IN THE NAME OF ALLAH,...Prof. Dr. Tarek Hassan El-Metwally, Professor of Medical Biochemistry and...

IN THE NAME OF ALLAH,

THE MOST GRACIOUS, THE MOST MERCIFUL

JUMJ Editorial Board and Description

Jouf University Medical Journal (JUMJ), 2018 December 1; 5(4): i - ii.

2018 2018

JUMJ EDITORIAL BOARD AND DESCRIPTION

EDITORIAL BOARD

AUMJ Editor-in-Chief

Prof. Dr. Saleh Abdul Allah Al-Damegh, Professor of Radiology, General Supervisor for Unaizah Colleges New campus at Qassim University, Founding Dean of Unaizah College of Medicine and Applied Medical Sciences, Qassim University, Qassim, Saudi Arabia.

AUMJ Associate Editor-In-Chief

Prof. Dr. Tarek Hassan El-Metwally, Professor of Medical Biochemistry and Molecular Biology & Consultant Clinical Biochemist, Biochemistry Division, Department of Pathology, CME Coordinator, College of Medicine, Jouf University, Sakaka, Saudi Arabia.

AUMJ DEVELOPMENT HISTORY

Jouf University Medical Journal (JUMJ) is issued under the general supervision of his esteem Dr Salim M. ALanazy, The vice-Rector of Jouf University for Graduate Studies and Scientific Research.

The inaugural issue of JUMJ first appeared September 1, 2014 with Prof. Dr. Saleh A. Al-Damegh, Founding Dean of Unaizah College of Medicine and Applied Medical Sciences and General Supervisor for Unaizah Colleges New Campus at Qassim University, Qassim University, Qassim, Saudi Arabia, as the Founding Editor-In-Chief.

The journal was initially name as Aljouf University Medical Journal (AUMJ). As the university name changed into Jouf University, the journal's name was also modified into Jouf University Medical Journal (JUMJ) starting from the 3rd issue of the year 2018.

AUMJ Editors

Prof. Dr. Parviz M Pour, Professor of Pathology, Department of Pathology and Molecular Biology, UNMC, NE, USA.

Prof. Dr. Azmi Mohammad-Ghaleb Darwazeh, Department of Oral Medicine, Faculty of Dentistry, Jordan University of Science & Technology, Ramtha, Jordan.

Prof. Dr. Maged A. El-Setouhy, Substance Abuse Research Center (SARC) and Department of Family and Community Medicine, College of Medicine, Jazan University, Jazan, Saudi Arabia, Department of Community, Environmental and Occupational Medicine, Faculty of Medicine, Ain Shams

University, Cairo, Egypt, and, Part-time visiting professor, Department of Emergency Medicine, Maryland University at Baltimore, Maryland, USA.

Dr. Adel A. Maklad, Associate Professor, Department of Neurobiology & Anatomical Sciences, University of Mississippi Medical Center, MS, USA.

Dr. Abdulrahman A. Alduraywish, Associate Professor, Consultant Endocrinologist and Head of the Department of Internal Medicine, College of Medicine, Jouf University, Sakaka, Saudi Arabia.

AUMJ DESCRIPTION AND SCOPE

JUMJ (pISSN: 1658-6700) is an online Open-Access and printed General Medical Multidisciplinary Peer-Reviewed International Journal that is published quarterly (every 3 months; March, June, September and December) by the Deanship for Graduate Studies and Scientific Research as the official medical journal of Jouf University, Sakaka, Saudi Arabia (http://vrgs.ju.edu.sa/jer.aspx).

JUMJ full text articles and their serial code Digital Object Identifier (DOI) address number (according to the International DOI Foundation) are accessible online through searching Journals for Aljouf University Medical Journal at Al-Manhal Platform (https://platform.almanhal.com/Search/Result?q=&sf_21_0_3=Aljouf+University+Medical+Journal&opsf_21_0=1&f_title_type_exact_loc_en=Article&opf_title_type_exact_loc_en=2). JUMJ is indexed by the three major players in the world of academic library discovery services: EBSCO Discovery Services (EDS), OCLC (Worldcat Discovery) and ProQuest (SUMMON). The DOI of AUMJ is 10.12816.

JUMJ welcomes and publishes innovative original manuscripts encompassing all Basic Biomedical and Clinical Medical Sciences, Allied Health Sciences - Dentistry, Pharmacy, Nursing and Applied Medical Sciences, and biological researches interested in basic and experimental medical investigations. Such research includes both academic researches (basic and translational) and community-based practice researches.

AUMJ AUDIENCE

Physicians, Clinical Chemists, Microbiologists, Pathologists, Hematologists, and Immunologists, Medical Molecular Biologists and Geneticists, Professional Health Specialists and Policymakers, Researchers in the Basic Biomedical, Clinical and Allied Health

http://vrgs.ju.edu.sa/jer.aspx

https://platform.almanhal.com/Search/Result?q=&sf_21_0_3=Aljouf+University+Medical+Journal&opsf_21_0=1&f_title_type_exact_loc_en=Article&opf_title_type_exact_loc_en=2




JUMJ Editorial Board and Description

Jouf University Medical Journal (JUMJ), 2018 December 1; 5(4): i - ii.

2018 2018

Sciences, Biological Researchers interested in Experimental Medical Investigations, Educators, and interested members of the public around the world.

AUMJ MISSION

JUMJ is dedicated to expanding, increasing the depth, and spreading of updated internationally competent peer reviewed genuine and significant medical knowledge among the journal target audience all over the world.

AUMJ VISION

To establish JUMJ as an internationally competent journal within the international medical databases in publishing peer reviewed research and editorial manuscripts in medical sciences.

AUMJ OBJECTIVES

1. To evolve JUMJ as a reliable academic reference within the international databases for researchers and professionals in the medical arena.

2. Providing processing and publication fee-free open-access vehicle for publishing genuine and significant research and editorial manuscripts for local, regional, and international researchers and professionals in medical sciences, along with being a means of education and academic leadership.

3. Expanding, increasing the depth, and spreading of internationally competent and updated medical knowledge among the JUMJ target audiences for the benefit of advancing the medical service to the local and international communities.

4. While insuring integrity and declaration of any conflict of interest, JUMJ is adopting an unbiased, fast, and comprehensively constructive one-month peer review cycle from date of submission to notification of final acceptance.

PUBLICATION FEE & SCHEDULE

JUMJ is processing and publication fee-free as a strategy of Jouf University in support of investigators worldwide. However, subscription to the journal and reprint (black and white or color) requests are placed through Deanship of Library Affairs at Jouf University. JUMJ is a bimonthly journal. Average processing time is 2 months; one month from receipt to issuing the acceptance letter and one month for providing the paginated final PDF file of the manuscript. Abstracts and PDF formatted articles are available to all Online Guests free of charge for all countries of the world. JUMJ is published quarterly (every 3 months) March, June, September and December 1st.

EDITORIAL OFFICE & COMMUNICATION

Jouf University Medical Journal (JUMJ), Jouf University, POB: 2014 Sakaka, 42421, Aljouf, Saudi Arabia.

Email: [email protected]

Tel: 00966146252271

Fax:00966146247183

SUBSCRIPTION & EXCHANGE

Deanship of Library Affairs, Jouf University, POB: 2014 Sakaka, 42421, Aljouf, Saudi Arabia.

Email: [email protected]

Tel: 00966146242271

Fax: 00966146247183

Price and Shipping Costs of One Issue is 25 SR within KSA and 25 US$ Abroad.

mailto:[email protected]

JUMJ Table of Contents

Jouf University Medical Journal (JUMJ), 2018 December 1; 5(4): iii.

2018 2018

Table of Contents

Jouf University Medical Journal (JUMJ), 2018 December 1; 5(4)

Content Pages

Description of AUMJ. i-ii

Table of Contents. iii

Review Article:

Intravitreal Steroid Implant in Treatment of Diabetic Macular Edema: A Review. Abdulaziz M. Al-Hadlaq.

Original Articles:

Conformal CT Planning vs. Conventional Planning for Supra-Clavicular Lymph Nodes Irradiation in Egyptian Patients with Breast Cancer: Impact of Body Mass Index. Alaa A. Fayed, Bader

A. Abdelmaksoud, Mostafa M. Toam.

1 – 7

9 – 16

Unmet Needs of Depression among University Students: A Northern Saudi Cross-Sectional Study. Ashokkumar Thirunavukkarasu,

Balaji Arumugam, Khaled Saher Alanazi, Ibrahim Yousef Alajaj, Faisal Khalid S. Alrashed, Amnah Ibrahim E. Alsirhani, Hanan Abdulrahman A. Alfayyadh.

17 – 26

The use of an Electronic Augmentative Communication Device to assess the needs of Mechanically Ventilated Patients in Critical Care. Aziza M. Salem, Nagwa M. A. Mohamed.

27 - 32

JUMJ Comprehensive Instructions For Authors and Reviewers. 33 – 46

Manuscript Submission and Copyright Transfer Form. 47

JUMJ Table of Contents

Jouf University Medical Journal (JUMJ), 2018 December 1; 5(4): iii.

2018 2018

Al-Hadlaq - Intravitreal steroid implant in treatment of diabetic macular edema: A review

Jouf University Medical Journal (JUMJ), 2018 December 1; 5(4): 1 - 7.

2018 2018

Review Article

Intravitreal Steroid Implant in Treatment of Diabetic Macular Edema: A Review

Abdulaziz M. Al-Hadlaq

Department of Ophthalmology, College of Medicine, Qassim University, Buraidah, Qassim, Saudi Arabia.

For correspondence: [email protected]

Abstract

Background: In view of the high cost and unknown number of anti-angiogenic intravitreal injections to be given to treat diabetic macular edema (DME), steroid implant in the vitreous cavity became a widely accepted treatment modality in recent years.

Objectives: We present the review of articles published on the intravitreal steroid implant in treatment of diabetic macular edema to study rationale, advantages and disadvantages of using these implants.

Methods: We conducted literature search using PubMed, Google scholar, M-Base, and data bases available through the Saudi Digital Library to trace all published full articles, book chapters, and theses on steroid implants in treatment of DME. Articles in other than English were excluded. More emphasis was paid to clinical trials, reviews, meta-analysis and longitudinal studies with adequate samples.

Results/Findings: Intravitreal implant to deliver both dexamethasone and fluocinolone are effective in reducing retinal thickness, reduce edema and less often improve vision. Fluocinolone antiinflammatory has longer lasting effect compared to dexamethasone since it duration is much longer. The method of insertion of implant is simple and could be a day care procedure. It also can be performed in conjunction with other ocular procedures. Complications, like cataract and increase in intraocular pressure are transient and should be monitored and managed medically. Steroid implant is better option than the conventional direct injection of antiinflammatory drugs and the frequently required anti-VEGF injection to treat DME. Cost effectiveness and long-term outcomes need to be further studied.

Conclusions/Implications: Steroid delivery using implants to treat DME seems to be cost-effective and have promising short-term results. However, long-term outcomes are awaited to decide evidence-based treatment policy.

Key words: Intravitreal steroid implant, Diabetic macular edema, Dexamethasone, Fluocinolone, Vascular Growth Factor inhibitors.

Citation: Al-Hadlaq AM. Intravitreal steroid implant in treatment of diabetic macular edema: A review. JUMJ, 2018, December 1, 5(4): 1 - 7.

Introduction

Diabetes is a non-communicable disease of epidemic proportions. Globally there were 451 million adult suffering from diabetes in 2017 and they would increase to 693 M in 2045

(1). Its complication in

eye; diabetic retinopathy (DR) is prevalent in 34.6% and diabetic macular edema (DME) is noted in 6.8% of persons with diabetes

(2). Vision-related functional

burden was significantly greater among those with severe Non-Proliferative DR

(NPDR) or Proliferative DR (PDR) than those without diabetic retinopathy

(3). The

most common cause of vision loss in patients with DR is DME. It is characterized by swelling or thickening of the macula due to sub- and intra-retinal fluid accumulation due to breakdown of the blood-retinal barrier (BRB)

(4).

In addition to the primary prevention of diabetes, the risk factors of DR if addressed in time, one can reduce visual impairment. Prompt treatment of Sight



2018 2018

Threatening Diabetic Retinopathy (STDR) that comprises DME include pan retinal photocoagulation (PRP), focal laser, intravitreal injections of anti-vascular growth factors and surgeries for tractional retinal detachment (TRD) and vitrectomies for vitreous hemorrhage

(5,6).

Progression of DR & impact of treatment on DME are monitored using non-invasive retinal imaging techniques

(7,8).

Non-mydriatic retinal photography and optical coherence tomography (OCT) are widely used and scope of tele-consultation have increased the chances of reaching to the underprivileged diabetic population at remote places

(9,10).

Uptake of the recommended periodic DR screening is low

(11). Perhaps patient

perceived severity of DR which is mainly based on its effect on vision could act as barrier for a high uptake of annual DR screening. In early stages of DR, vision is often not affected which could set lethargy among diabetic patients for subsequent and regular DR screening thinking that it is an asymptomatic issue

(12).

The viability of macula is so crucial in diabetes that in advanced PDR, PRP is carried out sacrificing the peripheral retina and thus perfusion of central retina is maintained/improved

(13). However, this

hypothesis is debated recently(14)

. Even the prognosis of TRD in diabetic patient depends on whether the macula is involved in TRD

(14). Scotoma in the

central field of vision negatively affects the reading and writing of person and vision related quality of life of diabetic patients

(15). Thus, marinating/improving

macular function is the goal of the service provider and person with diabetes.

Pathophysiologic study of DME has suggested an element of inflammation due to hypoxia which is responsible for a number of chemical stimulator for abnormal vascular growth

(16). The DME,

therefore, respond to steroid therapy in addition to anti-vascular growth factor (AVGF) inhibitors. Oral or parental steroid often have serious side effects especially in elderly patients posing a risk of hypertension, glaucoma, secondary infections and glucose intolerance

(17).

Intravitreal injections are, therefore,

treatment of choice for DME so that the concentration of steroid remains high at the pathological site and systemic side effects are minimized.

In countries where healthcare provision is state affair, like in the Saudi Arabia, the cost of treatment would be crucial to determine long-term management of DME. The conventional intravitreal injections of AVGF like Ranibizumab (Lucentis), Aflibercept (Eylea) and bevacizumab (Avastin) need to be administered frequently; even every month

(18). The former two AVGFs are

expensive while bevacizumab although less expensive, FDA has not yet approved its intraocular use

(19). Thus it is not clear

how many injections of which medication is suitable for a diabetic patient. The protocol for giving these injections is also not uniform in all countries

(20). In these

circumstances, care providers and diabetic patients prefer a drug delivery system which is near the pathology site, provide drug for a long time, does not cause discomfort and is still affordable.

Types of steroid implants

The advent of implants in vitreous cavity that release steroids slowly over a period of time commenced in 2009 with Ozurdex® (Allergan Inc) having 0.7 mg dexamethasone and was followed in 2017 by Iluvien® (Alimera Sciences) containing 0.19 mg fluocinolone acetonide

(21,22). While Ozurdex requires

replacement after 6 - 7 months, Iluvien has efficacy for 36 months

(23,24).

Fluocinolone acetonide is also marketed as RETISERT

® (Bausch & Lomb) in a

dose of 0.59 mg for treatment of DME & its effect lasts for 2.5 years

(25).

Composition of implants

These implants have outer cover made up of the polymers of synthetic aliphatic polyesters of the poly-α-hydroxy acid family including polylactic acid, polyglycolic acid, and polylactic-co-glycolic acid

(26). In Ozurdex, the implant

consists of a biodegradable copolymer of polylactic-co-glycolic acid which eventually breaks down into carbon dioxide and water

(27). Thus its removal

from the eye is not required. The dexamethasone is released from the



2018 2018

implant slowly for over six months. Iluvien

® has 0.19 mg of the active

ingredient fluocinolone acetonide and inactive slow degradable ingredient made of polyimide tube

(28). Composition of the

three brands available in the market; Iluvien (pSivida Corp), Retisert (Bausch & Lomb) and Yutiq (EyePoint) is similar.

Indications for steroid implant

In addition to treat DME, steroid implants are indicated to treat central retinal vein occlusion (CRVO), and non-infectious chronic uveitis

(29,30).

Steps of implantation

After taking aseptic precaution and anesthetizing the eye with topical medication, the implant is inserted using 20 to 23 gauge needle which is inserted from the infro-temporal quadrant of the eyeball. Conjunctiva is usually fixed by a swab stick. The injection is performed at 20 degree angle with objective of inserting the implant away from the macula and the visual axis and to place it in the inferior quadrant. The procedure is described in details by the experts

(31).

Possible intraoperative complications include subconjunctival hemorrhage, misplaced implant, increased intraocular pressure (IOP), retinal breaks/detachment and endophthalmitis

(27,32).

The implant and Cataract

Steroid implants were approved initially to treat DME in phakic eye of a patient not suffering from glaucoma

(33). This is

because of high risk of implant migrating in the anterior chamber in aphakic eye or in eye with weak capsular support. In phakic patients, nearly half of the lens showed cataract progression

(34). The

biodegradable material of the implants; Ilivien and Retisert were highly associated with cataract development and glaucoma

(35). Cataract surgeries by

phacoemulsification along with intravitreal steroid implantation were successfully carried out without any additional risk

(36). The cause of

progression of cataract following implant in phakic eye could be either surgical trauma or disturbance in physiology of lens.

Implant and rise of intraocular pressure

Rise in IOP is common occurrence after steroid implants intravitreal in treatment of DME

(37). As many as 28% of eyes with

implant developed raised IOP which needed medical management

(34). The risk

varied with the type of steroid implant used. It was 32% with conventional triamcinolone injection, 79% with fluocinolone and 11 - 15% with dexamethasone implants

(38). Periodic

monitoring of IOP and documenting the field of vision changes for a long time is suggested to DME patients to be treated with steroid implant especially fluocinolone. They should also be explained for the risk and need for glaucoma surgery in long term if such complication occur

(39).

Other complications of implant

In addition to the raised IOP and progression of cataract, a number of complications are documented in the literature. They include, sterile and infective endophthalmitis, migration of implant to anterior chamber, in advert insertion of implant in crystalline lens, and, transient rise of LDL-cholesterol levels

(40,41). Following the recommended

protocol for implant insertion and regular monitoring of eye to detect complication in early stages are recommended.

Implant with other treatment regimen for DME

The steroid implantation attempted in both eyes of a patient was found to be well-tolerated. Bilateral implantation is proposed as same day procedure to save indirect costs and treatment burden

(42). In

addition to steroid implant procedure, phacoemulsification cataract surgery

(35),

focal laser treatment for DME(43)

and vitrectomy with silicone oil tamponade

(44)

have also been performed in one sitting.

Anatomical and visual outcomes of steroid implant

Short-term and long-term reduction of DME can be effectively evaluated using OCT

(9). The functional success was

measured as change in distance visual acuity. The steroid implant treatment was reported to have significant anatomical outcomes. However, improved visual outcome was not significant

(45). In

contrast, Singer et al(46)

reported in their



2018 2018

large multi-center study that steroid implant provided promising anatomical and visual outcomes. The anatomical success correlated to visual acuity improvement but more so for red green color than yellow – blue color

(47). The

steroid implantation treatment was noted to have better visual outcome and reduction of central macular thickness compared to refractory DME cases

(48).

The visual outcomes in intravitreal injections compared to sham treatment have shown 21% vs. 11.1% improvement of more than 15 letter in BCVA. However internal comparison of visual gain among different types of steroid implant was not reviewed to the best of our knowledge.

Patient satisfaction for steroid implant

Client perspective of an ocular intervention is best evaluated by assessing the change in Health-related Quality of Life (HQL). In a study treatment satisfaction was reported but in absence of benchmark score, HQL impact was a challenge. They also found that visual acuity, central foveal thickness and macular volume influenced the patient satisfaction

(49). Health-related QoL and

patient-related outcome measures (PROM) were assessed by using the Retinopathy-Dependent Quality of Life (RetDQoL) questionnaire, Visual Function Questionnaire-25 (VFQ-25) and Retinopathy Treatment Satisfaction Questionnaire (RetTSQ). The researchers noted that VQL & PROM were correlated to VA, CMR & macular thickness at 12 months after implant treatment

(49).

Cost effectiveness of implant

Comparison of different licensed intravitreal therapy revealed that steroid implant enables service provider in reducing the treatment cost for DME compared to intravitreal injections of anti VEGF

(50). Among them, fluocinolone was

found to be more cost effective than other regimen

(51). This UK study evaluated

quality-adjusted life years (QALYs) in eyes having dexamethasone intravitreal implant vs. conventional care for DME. It was noted that 0.126 additional QALYs in 15 year could be saved with additional cost of £1777

(51).

Conclusion

The drug delivery using implants in eye have not only revolutionized the treatment modality of DME, but it also has reduced frequency of interventions, improved response and reduced the cost of treatment. The initial promising reports which could be industry-supported research have subsequently been complimented by independent research and long term outcomes support their use but with a caution to monitor development of possible complications and manage them promptly. One should remember that primary prevention of both diabetes and diabetic retinopathy is nonnegotiable in spite of promise of implant treatment in addressing this sight threatening ocular condition.

Funding

This review was funded by Qassim University as a part of the author's employment duties.

Conflict of Interests

The author declared no conflict of interests.

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41. Valverde-Megías A, Cifuentes-Canorea P, Ruiz-Medrano J, Peña-García P, Megías-Fresno A, Donate-López J, García-Feijoo J. Systemic Effects of Repeated Intraocular Dexamethasone Intravitreal Implant in Diabetic Patients: A Retrospective Study. Diabetes Ther., 2017; 8(5):1087-96.

42. Kapoor KG, Colchao JB. Safety of consecutive same-day bilateral intravitreal dexamethasone implant (Ozurdex). Retin Cases Brief Rep., 2017 Nov 16. doi: 10.1097/ICB.0000000000000653. (ahead of print).

43. Elhamid AHA. Combined intravitreal dexamethasone implant and micropulse yellow laser for treatment of anti-vegf resistant diabetic macular edema. Open Ophthalmol J., 2017;11:164-72.

44. Banerjee PJ, Quartilho A, Bunce C, Xing W, Zvobgo TM, Harris N, Charteris DG. Slow-Release Dexamethasone in Proliferative Vitreoretinopathy: A Prospective, Randomized Controlled Clinical Trial. Ophthalmology, 2017;124(6):757-67.

45. He Y, Ren XJ, Hu BJ, Lam WC, Li XR. A meta-analysis of the effect of a dexamethasone intravitreal implant versus intravitreal anti-vascular endothelial growth factor treatment for diabetic macular edema. BMC Ophthalmol., 2018;18(1):121.

46. Singer MA, Dugel PU, Fine HF, Capone A Jr, Maltman J. Real-world assessment of dexamethasone intravitreal implant in DME: Findings of the prospective, multicenter REINFORCE Study. Ophthalmic Surg Lasers Imaging Retina, 2018;49(6):425-35.

47. Abdel-Hay A, Sivaprasad S, Subramanian A, Barbur JL. Acuity and colour vision changes post intravitreal dexamethasone



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implant injection in patients with diabetic macular oedema. PLoS One, 2018;13(6):e0199693.

48. Castro-Navarro V, Cervera-Taulet E, Navarro-Palop C, Monferrer-Adsuara C, Hernández-Bel L, Montero-Hernández J. Intravitreal dexamethasone implant Ozurdex® in naïve and refractory patients with different subtypes of diabetic macular edema. BMC Ophthalmol., 2019;19(1):15.

49. Ramu J, Chatziralli I, Yang Y, Menon G, Bailey C, Eckstein M, Hykin P, Sivaprasad S. Health-related quality of life, visual function and treatment satisfaction following intravitreal dexamethasone implant for diabetic macular edema. Patient Prefer Adherence, 2017;11:579-86.

50. Neubauer AS, Haritoglou C, Ulbig MW. Cost Comparison of Licensed Intravitreal Therapies for Insufficiently Anti-VEGF Responding Fovea Involving Diabetic Macular Edema in Germany. Klin Monbl Augenheilkd., 2019;236(2):180-91.

51. Pochopien M, Beiderbeck A, McEwan P, Zur R, Toumi M, Aballéa S. Cost-effectiveness of fluocinolone acetonide implant (ILUVIEN®) in UK patients with chronic diabetic macular oedema considered insufficiently responsive to available therapies. BMC Health Serv Res., 2019;19(1):22.



2018 2018

Fayed et al - Conformal CT Planning versus Conventional Planning for Supra-Clavicular …..


2018 2018

Original Article

Conformal CT Planning vs. Conventional Planning for Supra-Clavicular Lymph Nodes Irradiation in Egyptian Patients with

Breast Cancer: Impact of Body Mass Index

Alaa A. Fayed, Bader A. Abdelmaksoud*, Mostafa M. Toam

Department of Clinical Oncology and Nuclear Medicine, Faculty of Medicine, Zagazig University, Zagazig, Egypt.

*Corresponding Author: [email protected]

Abstract

Background: Irradiation of supra-clavicular lymph nodes (SC-LNs) is an integral part of breast cancer radiotherapy. Efforts were exerted to improve dose distribution to this area for proper coverage of target volume & to decrease radiation dose to organs at risk.

Objectives: We aimed at improving the outcome of the dose homogeneity and distribution during breast radiotherapy - to allow better dose coverage of supra-clavicular fossa/field (SCF) with consequent decrease of the radiation dose to normal organ at risk. Effect of variation in body mass index (BMI) was also assessed. We compared the conventional treatment planning vs. conformal method. The acute side effects after radiotherapy were also assessed.

Patients and Methods: Fifty one women with invasive breast cancer and had indication for SC-LNs irradiation were included. After primary surgery and chemotherapy, patients were divided into 3 groups (n = 17) according to BMI - normal (18.5-24.9), overweight (25-29.9) and obese (≥30). All patients were subjected to three treatment planning techniques, the 1

st plan conventionally used 6MV photons prescribed to 1.5

cm, the 2nd

plan was also conventional and used 6MV photons prescribed to 3 cm depth, and, the 3

rdplan was 3D CT-based conformal combined 6 and 15MV photons

optimized manually so as the target volume is covered with 90% of the prescribed dose. The three plans were compared regarding: 1) mean dose to SCF, 2) percent of SCF target covered by >90% of prescribed dose, and, 3) hot spots and mean dose to heart and lung. Then, BMI was correlated with the depth of SCF.

Results: Regarding the maximum dose within planning target volume (PTV), 3rd

plan was the best in all BMI classes with lowest hot spots than the other two plans (103.88% in normal, 104.64% in overweight, and 104.23% in obese), followed by 2

nd plan

(107.7% in normal, 109.88% in overweight, and 107.52% in obese), then 1st plan was

the worst plan across in all BMI classes (113.70% in normal, 114.76% in overweight, and 112.64% in obese). The differences were statistically highly significant across the three BMI classes. Regarding the coverage by 90% of prescribed dose, 3

rd plan was the

best in all BMI classes (96.05% in normal, 95.23% in overweight, and 95.41% in obese) followed by 2

nd plan (92.64% in normal, 91.58% in overweight, and76.47% in obese),

but1st

plan was the worst across all BMI classes (87.76% in normal, 78.52% overweight, and 82.29% in obese). The 3

rd plan was the best in all BMI classes having lowest mean

heart (nonsignificantly different from the other two plan) and lung dose (high significantly different from the other two plans).

Conclusion: The 3D conformal planning for SCLNs had better covering of the target volume and offered more homogenous dose distribution than the two conventional planning across all BMI classes - with lowest heart and lung exposure. 3

rd plan of

combined 6/15 MV should be a routine treatment planning for SCF in breast cancer.

Keywords: Radiotherapy, Treatment planning, Supra-clavicular lymph nodes, Breast cancer.

Citation: Fayed AA, Abdelmaksoud BA, Toam MM. Conformal CT Planning vs. Conventional Planning for Supra-Clavicular Lymph Nodes Irradiation in Egyptian Patients with Breast Cancer: Impact of the Body Mass Indices. JUMJ, 2018, December 1, 5(4): 9 - 16.



2018 2018

Introduction

Globally, breast cancer is the most common cancer and the leading cause of cancer deaths among females; accounts for 23% of the total cancer cases and 14% of the cancer death

(1). Adjuvant

radiotherapy is an essential part of breast cancer treatment; it provides 70-75% decrease of risks of loco-regional relapse after mastectomy

(2). The American

Society of Clinical Oncology (ASCO) recommends the use of post-mastectomy radiotherapy (PMRT) for patients whose primary tumor is larger than 5 cm and/or patients who have four or more involved axillary lymph nodes (ALNs)

(3).

Recent trials have been published showing the positive impact of PMRT on overall survival even in patients having 1-3 positive ALNs with T1-T2 primary disease or early breast cancer

(4). As part of

PMRT, the supra-clavicular fossa/field (SCF) is treated if four or more ALNs contain metastatic disease or if the extent of nodal disease is unknown or uncertain - because the axilla either has not been treated surgically or the surgery has been suboptimal. This is because SCF recurrence is the second most common site of recurrence following mastectomy; to chest wall recurrence provided that the axilla is treated surgically

(5).

Variations in practice have been documented in surveys done by the Radiation Oncology Expert Advisory Group of the National Breast Cancer Centre regarding SCF field size, treatment parameters and depth

(6). Simulation using

CT is now widely available for radiation treatment planning of breast cancer. It is an important tool to help defining the tumor target and normal tissue; based on anatomical features of an individual patient. However, despite the availability of this technology, a common practice for delivering radiation to SC nodal bed during breast cancer treatment is to use 6 MV photons empirically prescribed to the depth of maximum dose (Dmax); 1.5 cm or 3 cm. It is likely that empiric prescription depth points may not properly cover the target nodal basin in all patient

(7).

In this study, we aimed to improve the outcomes of the dose distribution and

homogeneity and to achieve better coverage to SCF with decreasing dose to organ at risk; considering Body Mass Index (BMI). For that, we compared two 2½D conventional planning methods (1

st

6MV photons/1.5 cm depth, and, 2nd

6MV photons/3 cm depth) vs. 3

rd plan method

(3D conformal combined 6/15MV photons) and to detect acute side effects following radiotherapy, e.g., skin reaction, radiation pneumonitis.

Patients and Methods

Eligibility criteria

This prospective clinical study was conducted at Department of Clinical Oncology and Nuclear Medicine, Faculty of Medicine, Zagazig University, Zagazig, Egypt in the period from March 2015 to February 2016, It enrolled 51 patients with breast cancer; with the following inclusion criteria: Female patient >18 years with histopathological confirmation of invasive unilateral breast carcinoma, underwent conservative surgery or mastectomy, had indication of supra-clavicular LNs irradiation, no previous radiotherapy, and, no contraindication to radiotherapy (cardiovascular, e.g., pace maker implantation). Oral and written informed consent was taken from every participant. The protocol this study was approved by the Bioethics and Scientific Ethical Committee of the faculty of Medicine, Zagazig University.

Study design and patient follow-up

Patients met the above mentioned inclusion were divided into 3 equal groups of 17 patients according to BMI; normal (BMI = 18.5-24.9), overweight (BMI = 25-29.9) and obese (BMI ≥30). Each patient was subjected to three treatment planning techniques for SCF. The best planning technique regarding the homogeneity and minimizing dose to organs at risk was applied to the patient. 1

st plan was 2½D conventional plan that

used 6MV photons prescribed to 1.5 cm depth of maximum dose (Dmax, 6MV-1.5), the 2

nd plan was 2½D conventional

plan that used 6MV photons prescribed to 3 cm depth (6MV-3.0), and, the 3

rd 3D

conformal plan combined 6MV and 15MV (6/15MV) photons that were



2018 2018

manually optimized to cover the target volume with 90% of the prescribed dose. The three plans were compared regarding the mean dose to SCF, % of SCF target covered by >90%of prescribed dose, and, hot spots and mean dose to heart and lung. In the CT-based planning, the isodose surface was 90% vs. 40% in conventional planning. At 80% power and 95% CI, the estimated sample size is 17 in each group. The patient's BMI was correlated with the depth of SCF. Each patient was evaluated monthly and for 6 months by clinical examination and chest X-ray.

Statistical analysis

All data were analyzed using Statistical Package for Social Science for Windows version 18.0 (SPSS Inc., Chicago, IL, USA) & MedCalc for Windows version 13 (MedCalc Software bvba, Ostend, Belgium). Quantitative data were expressed as mean ± SD and the qualitative data were expressed as frequency; number (n) and %. Continuous variables were checked for normality by using Shapiro-Wilk test. Independent Student t-test was used to compare two groups of normally distributed data, while Mann-Whitney U test was used for non-normally distributed data. One-Way ANOVA was used to compare more than two groups with normally distributed data, while Kruskal-Wallis H test was used for non-normally distributed data multiple comparisons. Post-hoc test was done by multiple head to head comparisons using Paired t test for normally distributed data & Wilcoxon signed ranks test for non-normally distributed data. Percent of categorical variables were compared using χ

2 test. All

tests were two sided. P <0.05 was considered statistically significant.

Results

Basic characteristics

Basic characteristics of the studied patients are summarized in Table 1. Their mean age was 46 years. 54.9% of them had right-sided breast cancer. About 52.9% of them presented with pathological T2. Also 52.9% of patients presented with pathological N3. Most of patients underwent modified radical

mastectomy (MRM; 62.7%) and remaining underwent breast conserving surgery (BCS). Pathology for all patients was confirmed as invasive duct carcinoma.

Table 1: Characteristics of the studied breast cancer patients (total n = 51). Data shown are frequency; n (%), mean ± SD and median (range). MRM = Modified radical mastectomy and, BCS = Breast conserving surgery.

Characteristic n (%)/Mean ± SD Median (range)

Age, years

Mean ±SD 45.92 ± 9.35 46 (29 – 66)

Laterality Right breast

28 (54.9)

Left breast 23 (45.1)

T T1 9 (17.6)

T2 27 (52.9)

T3 15 (29.4)

N N1 10 (19.6)

N2 14 (27.5)

N3 27 (52.9)

Surgery BCS 19 (37.3)

MRM 32 (62.7)

Comparison between the three plans; 6MV-1.5, 6MV-3.0 and 6/15MV

The dosimetric parameters for the three plans are shown in Table 2. The mean doses of the 3D conformal 6/15MV, 6MV-1.5, and 6MV-3.0 plans were 97.41%, 90.7% and 92.5% of the prescribed dose, respectively (P<0.001). Dmax was 104.2%, 108.39% and 113.7% of the prescribed dose, respectively (P <0.001). The volume % of SCF covered with 90% of the prescribed dose were 95.56%, 82.86% and 86.9% of the prescribed dose, respectively (P <0.001). The mean heart doses were 2.60%, 2.69% and 3% of the prescribed dose, respectively with nonsignificant differences (P = 0.138). The mean lung doses were 9.66%, 11.25% and 11.35% of the prescribed dose, respectively (P <0.001).

Comparison between the three plans; 6MV-1.5 cm, 6MV-3 cm and 6/15MV for different BMIs

Table 3 shows the relationship between BMI and dosimetric parameters for the three plans. Regarding the mean dose,



2018 2018

6/15MV was the best in for all BMI classes (98.05% in normal, 96.82% in overweight, and, 97.32% in obese) followed by 6MV-3.0 (91.94 for normal, 91.88% in overweight, and 93.94% for obese), while 6MV-1.5 was the worst plan across all BMI classes (90.70% for normal, 91.29% for overweight, and 90.35% for obese). The differences were statistically highly significant across the three BMI classes (P <0.001). Regarding Dmax within planning target volume (PTV), 6/15MV plan was the best in for all BMI classes with a lower hot spots than the other plans (103.88% in normal, 104.64 in overweight, and, 104.23% in obese) followed by 6MV-1.5 (107.7 for normal, 109.88% in overweight, and 107.52% in obese), while, 6MV-3.0 plan

was the worst plan across all BMI classes with Dmax doses of 113.70% for normal, 114.76% for overweight, and 112.64% for obese). The differences were statistically highly significant across the three BMI classes (P <0.001). Regarding the coverage for 90% of the prescribed dose for PTV, also 6/15MV plan was the best for all BMI classes (96.05% in normal, 95.23% in overweight, and 95.41% for obese) followed by 6MV-3.0 plan (92.64% in normal, 91.58% in overweight, and 76.47% in obese), while 6MV-1.5 plan stayed the worst across all BMI classes (87.76% in normal, 78.52% in overweight, and 82.29% in obese). The differences were statistically highly significant across the three BMI classes (P <0.001).

Table 2: Comparison between % dosimetric parameters for the three plans used for breast cancer radiotherapy in our patients (total n =51). Data shown are % mean ± SD and f and P values for Friedman's test (¶) or Repeated measure ANOVA test (*). SCF = Supraclavicular field.

Parameter 6/15MV plan 6MV-1.5 plan 6MV-3 plan f P

Mean dose to SCF 97.41 ± 5.64 90.78 ± 8.22 92.58 ± 6.84 72.385¶ <0.001

Max dose to SCF 104.25 ± 2.80 108.39 ± 4.82 113.7 ± 5.90 81.319¶ <0.001

% volume of SCF covered by 90% of the prescribed dose

95.56 ± 3.80 82.86 ± 11.85 86.90 ± 9.71 48.192¶ <0.001

Mean heart dose 2.60 ± 1.30 2.69 ± 1.06 3.0 ± 1.31 3.957¶ 0.138

Mean lung dose 9.66 ± 3.31 11.25 ± 3.59 11.35 ± 3.62 41.061* <0.001

Mean dose to the heart and lung

6/15MV plan was the best in all BMI classes with lowest mean heart dose, followed by 6MV-3.0 plan, then 6MV-1.5 plan that was the worst across all BMI classes. However, statistically the differences were non-significant across the three BMI classes. Also, 6/15MV plan was the best for all BMI classes with lowest mean lung dose, followed by 6MV-1.5 plan, while 6MV-3.0 plan had the highest mean dose across all BMI classes. Differences were highly significant different across the three BMI classes (Table 3).

Skin toxicities

Skin toxicity was evaluated monthly for 6 months after radiotherapy. There was no change over the base line in 23 patients (grade 0), faint or dry erythema was detected in 16 patients, and, bright erythema and patchy moist desquamation was detected in 11 patients. Only one patient suffered from wide moist

desquamation during the radiotherapy sessions and needed to stop radiotherapy sessions for 5 days and was treated with topical corticosteroids then radiotherapy sessions were continued. No patients suffered from grade 4 skin toxicity. No differences in skin toxicity among the three plans, and, across BMI classes. Radiation pneumonitis was not recorded for any patient.

Discussion

This study included 51 female patients divided into 3 groups according to BMI, for every patient in every group three plans were done. For breast cancer adjuvant radiotherapy, we employed two conventional plans; 6MV photons prescribed to 1.5 cm (Dmax, 6MV-1.5) or to 3 cm depth (6MV-3.0) along with a 3

rd

plan that combined 6MV and 15MV photons manually optimized to cover the target volume with 90% of the prescribed dose were created for comparison. 28 patients (54.9%) had right-sided cancer and 23 (45.1%) had left-sided tumor. All



2018 2018

patients received radiotherapy using the 3

rd6/15MV plan, optimally covered CT

simulation 50 Gy, in 25 fractions over 5 weeks from Saturday to Wednesday and were followed up for acute skin toxicity, radiation pneumonitis and brachial plexopathy - during and for 6 months after radiotherapy. These side-effects were correlated with patients' BMI. In our study, the dose in 6MV-3.0 plan to the supra-clavicular field (SCF) in all patients was 46.25 ± 3.42 Gy (i.e., 92.5 ± 6.84% of the prescribed 50Gy dose), while in the 3

rd 6/15MV plan dose to SCV was 48.7 ±

2.82 GY (i.e., 97.41 ± 5.64% of the prescribed 50 Gy dose). These findings are in accordance with the study carried out by Barsoum et al on 15 patients which favored 3

rd plan over 6MV-3.0 plan. In

conventional planning, the radiation dose to PTV was 4109.062 ± 1605.087 cGy, while in 3

rd plan it was 4902.132 ±

1134.469 cGy(8)

. In the 1st 6MV-1.5 plan

the dose to SCF in all patients was 45.39 ± 4.11 Gy (i.e., 90.78 ± 8.22% of the prescribed dose of 50 Gy) but there were no detailed available data form Barsoum's et al study for comparison

(8).

Table 3: Relationship between BMI and % dosimetric parameters for the three plans of treatment in the studied breast cancer patients (total n =51; n = 17 for each BMI subgroup). Data shown are mean ± SD and P values.

Parameter BMI 6/15MV plan 6MV-1.5 cm plan 6MV-3 cm plan P

Mean dose to SCF

Normal 98.05 ± 5.72 90.70 ± 10.37 91.94 ± 6.74 0.004

Overweight 96.82 ± 5.41 91.29 ± 7.67 91.88 ± 7.27 <0.001

Obese 97.35 ± 6.05 90.35 ± 6.65 93.94 ± 6.73 <0.001

P 0.821 0.605 0.617

Max dose to SCF Normal 103.88 ± 2.36 107.7 ± 4.76 113.70 ± 5.91 <0.001

Overweight 104.64 ± 2.8 109.88 ± 5.43 114.76 ± 6.99 <0.001

Obese 104.23 ± 3.28 107.52 ± 4.07 112.64 ± 4.76 <0.001

P 0.737 0.550 0.766

Volume of SC covered by 90% of prescribed dose

Normal 96.05 ± 2.70 87.76 ± 6.29 92.64 ± 3.08 <0.001

Overweight 95.23 ± 4.16 78.52 ± 9.42 91.58 ± 3.57 <0.001

Obese 95.41 ± 4.48 82.29 ± 16.28 76.47 ± 9.91 0.003

P 0.808 0.071 <0.001

Mean heart dose Normal 2.33 ± 1.03 2.83 ± 0.98 3.16 ± 1.16 0.050

Overweight 2.6 ± 1.34 2.40 ± 1.17 2.7 ± 1.56 0.582

Obese 2.85 ± 1.57 3.0 ± 1.0 3.28 ± 1.11 0.449

P 0.787 0.524 0.644

Mean lung dose Normal 9.88 ± 3.83 10.82 ± 3.69 11.05 ± 3.83 0.001

Overweight 9.41 ± 3.48 12.0 ± 4.25 12.0 ± 4.25 <0.001

Obese 9.70 ± 2.71 10.94 ± 2.79 11.0 ± 2.76 <0.001

P 0.919 0.586 0.674

In this study we found that the coverage by 90% of the prescribed dose was the best in 3

rd 6/15MV plan across all BMI

classes (96.05 ± 2.70% in normal BMI, 95.23 ± 4.16% in overweight, and, 95.41± 4.48% in obese patients). The conventional 6MV-3.0 plan came 2

nd and

was acceptable for normal BMI and overweight patients but was unsatisfactory for obese women (92.64 ± 3.08% in normal BMI, 91.58 ± 3.57% in overweight, and, 76.47 ± 9.91 % in obese

patients). The conventional 6MV-1.5 plan was the worst plan across all the BMI classes in coverage of PTV by 90% of the prescribed dose, and, was not acceptable for the three BMI classes (87.76 ± 6.29% in normal BMI, 78.52 ± 9.42% in overweight and, 82.29 ± 16.28% in obese patients). There were high statistically significant differences across the three BMI classes. Comparing PTV coverage by 90% of the prescribed dose in 3

rd

6/15MV plan and 6MV-3.0 plan



2018 2018

(P<0.001). The same was obtained by Goodman et al in 2001 treating 55 patients where coverage with 3

rd 6/15MV

vs. conventional 6MV/3.0 plan was statistically significant (P <0.003

(9). This

was also confirmed by Liengsawangwong et al working on 32 patients, where CT-optimized plans were the most successful among all plans for all BMI groups. But, 6MV-3.0 plan provided the adequate coverage only in some patients with normal and overweight BMI and was accepted only in 20% of obese patients. The criterion for acceptability was 90% of target volume receiving >90% of the prescribed dose

(10).

In another study conducted by Jabbari et al on 100 patients showed that the coverage by single anterior field with 3 cm depth with 90% at 88% PTV, which isn't optimal and they suggested using AP/PA fields for better coverage

(11).On

the other hand, the study carried out by Houshyari et al on 40 patients treated with anterior field 6MV-3.0, showed that the dose reaching 90% of PTV of SCF/≥90% of the prescribed dose in all BMI groups of patients. Thus, indicating that coverage of SCF was appropriate

(12). This is in

agreement with Madu et al(13)

treating 20 patients, they compared between a single anterior treatment field was set at 97 cm source-to-skin distance (depth 3 cm from skin surface) and 3

rd optimized conformal

plan. The latter covered 100% of SCF by the 90% isodose surface, whereas in the conventional plans about 93.3% (range is 44.7-98.2%) of SCF was covered by the 90% isodose surface.

Regarding the area of hotspots, in our study we found fewer hotspots for the 3D plan and was the best across all BMI (104.25 ± 2.80%), while in the 2½D plans the mean was 113.7 ± 5.90% for 6MV-3.0 and 108.39 ± 4.82%for 6MV-1.5. Therefore, the 3D plan was the best in all BMI classes for hotspots (103.88 ± 2.36 % in normal BMI, 104.64 ± 2.8 in overweight, and 104.23 ± 3.28 in obese patients), followed by 6MV-1.5 (107.7 ± 4.76 for normal BMI, 109.88 ± 5.43% in overweight and 107.52 ± 4.07% in obese patients), while 6MV-3.0 was the worst plan across all BMI classes having hotspots reaching 113.70 ± 5.91% for

normal BMI, 114.76 ± 6.99% for overweight, and 112.64 ± 4.76% for obese patients). These findings are in agreement with Liengsawangwong's et al study, where the conformal plan was the most successful for all BMI groups while the conventional 6MV-3.0 generated the most frequent hotspots reaching mean 105% of the prescribed dose

(10).

Houshyari et al study stated that although the coverage of the 2½D 6MV-3.0 plan was accepted in all BMI classes, it had hotspots reaching 120% of prescribed dose. The 3D conformal technique had fewer hot spots (102% of prescribed dose), while 6MV-1.5 plan hotspots reached 108%. The 3D technique had an overdose/point dose of 55 Gy (110% of the dose), while the 2½D 6MV-3.0 technique had an overdose of 61 Gy (122% of the dose)

(8,12).

In our study we found that the mean lung dose was lowest in the 3D plan (9.66 ± 3.13% of the prescribed dose) and did not differ among BMI classes (P = 0.919). In the 2½D 6MV-3.0 plan, lung dose was highest (11.35 ± 3.62%) with no significant difference across BMI groups (P = 0.674). In the 2½D 6MV-1.5 plan, lung dose was 11.35 ± 3.62% with no significant difference across BMI categories (P = 0.586). These results agreed with those of Aboziada et al who treated 20 patients. They compared the mean lung dose with SCF irradiation using the standard 6MV-3.0 single anterior field plan (with full dose prescribed to a point in the central axis 3 cm deep to the surface of the skin) vs. the 3D optimized plan. The mean dose to the lung was 10.5% and 8.74% of the prescribed dose, respectively

(14).

However, Barsoum et al reported lung dose of 20% (1021.428 ± 1206.461 cGy) of the prescribed dose in the 3D plan that was higher than that of 6MV-3.0 plan (15.2% of prescribed dose of 794.433 ± 001.589cGy)

(8). However, the mean heart

dose was higher in 6MV-3.0 plan compared to the 3D plan (2.60 ± 1.30% and 3 ± 1.31% of the prescribed dose, respectively). Also, in Barsoum's et al study, the 2½D planning showed radiation dose to the heart of 338.6 cGy (6.6% of the prescribed dose), while in their 3D



2018 2018

planning the dose was 612.1 cGy (12.2% of the prescribed dose)

(8).

And, finally regarding the follow up for acute toxicities during and after radiotherapy and considering BMI, our study revealed 32.4% had grade 1, 21.6% had grade 2 and only 2% suffered from grade 3 skin reactions. There were no changes from the baseline in 45.1% of patients and no one of the patients suffered from grade 4skin reaction. The relationship between skin toxicity and BMI classes was statistically significant. This is similar to reports of De Langhe et al and Yamazaki et al

(15,16). In our study

only two patients suffered from grade one pneumonitis (symptoms dry cough) with no radiological data. Both patients were in obese class and their lung dose was 20% (10Gy) and 19% (9.5 GY) of the prescribed dose, respectively. This is similar to observations from Chung et al

(17). There were no changes over

baseline and no symptoms predicting brachial plexopathy till the endpoint of our study. However, these data are inconclusive because all the new studies consider them as a late side effect and must be evaluated for at least 5 years. Despite the delivery of a higher dose of radiation to the brachial plexus volume by using the conformal technique, a higher rate of complications would not be expected with the dose restricted to 50 Gy

(8).

Conclusion

The 3D conformal radiotherapy planning for SC LNs allows better coverage of the target and offers more dose homogeneity than the conventional 2½D planning to 1.5 cm or 3 cm depth from skin surface across various BMI classes. Also, the 3D plan had lowest dose to organ at risk (heart and lung). Brachial plexus should be included in planning organ at risk during SC LNs irradiation. Skin reaction is usually more sever in high BMI classes due to dose inhomogeneity by the action of fat. Long term follow up should be done to evaluate the effect of radiation on lung and brachial plexus and the influence of BMI on these side-effects.

Limitations of the Study

The study limitations include its small sample size and short duration of follow-up that should be taken in consideration in further researches.

Funding

This study was funded by Zagazig University, Zagazig, Egypt as a part of the employment duties of the authors.


The authors declared no conflict of interests.

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6. Morgia M, Lamoury G, Morgan G. Survey of radiotherapy planning and treatment of the supraclavicular fossa in breast cancer. J Med Imaging Radiat Oncol., 2009;53(2):207-11.

7. Recht A, Comen EA, Fine RE, Fleming GF, Hardenbergh PH, Ho AY et al. Post-mastectomy Radiotherapy: An American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Focused Guideline Update. Pract Radiat Oncol., 2016;6(6):219-34.

8. Barsoum M, Mostafa M, El HossienyH, Nasr A, Mahmoud M, Fouda S. Dosimetric prospective study comparing 2½D and 3D planning for irradiation of supraclavicular and infra-clavicular regions in breast cancer patients. J Egypt Natl Can Ins., 2015; 27 (1): 25-34.



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9. Goodman RL, Grann A, Saracco P, Needham MF. The relationship between radiation fields and regional lymph nodes in carcinoma of the breast. Int J Radiat Oncol Biol Phys., 2001;50(1):99-105.

10. Liengsawangwong R, Tse-Kuan Y, Tzouh-Liang S. Treatment optimization using computed tomography-delineated targets should be used for supra-clavicular irradiation for breast cancer. Int J Radiation Oncol Biol Phy., 2007; 69(3): 711-5.

11. Jabbari K, Azarmahd N, Babazade S, Amouheidari A. Optimizing of the tangential technique and supraclavicular fields in 3 dimensional conformal radiation therapy for breast cancer. J Med Signals Sens., 2013;3(2):107-16.

12. Houshyari M, Kashi Y, Varaki S, Rakhsha A, Blookat ER. Regional lymph node radiotherapy in breast cancer: single anterior supra-clavicular field vs. two anterior and posterior opposed supra-clavicular fields. Electron Physician, 2015;7(2):1032-8.

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Thirunavukkarasu et al - Unmet Needs of Depression among University Students: …..


2018 2018

Original Article

Unmet Needs of Depression among University Students: A Northern Saudi Cross-Sectional Study

Ashokkumar Thirunavukkarasu1*

, Balaji Arumugam2, Khaled Saher Alanazi

3,

Ibrahim Yousef Alajaj3, Faisal Khalid S. Alrashed

3, Amnah Ibrahim E. Alsirhani

3,

Hanan Abdulrahman A. Alfayyadh3

1Department of Community Medicine, College of Medicine, Jouf University.

Department of Community Medicine, Tagore Medical College and Hospital, Chennai, India.

3College of Medicine, Jouf University, Sakaka, Saudi Arabia.

*Corresponding author: [email protected].

Abstract

Background: Depression is one of the commonest mental health problems affecting all age groups and communities. Accurate assessments of the need for depression by assessing their met and unmet needs are essential for effective planning for support services. Unnoticed and untreated depression is a contributor to suicide, which is one of the causes of death among 15-29-year-old young adults.

Objectives: The present study was aimed to assess the prevalence of depression among Jouf University students and to determine unmet needs of depression and its predictors.

Participants and Methods: An analytical cross-sectional study was done among 400 randomly selected students of healthcare and non-healthcare colleges of Jouf University, Sakaka, Saudi Arabia. Patient Health Questionnaire-9 (PHQ-9) was used to assess the depression status and their met and unmet needs of depression. Logistic regression analysis was done to identify the predictors of unmet needs of depression.

Results: Depression was found among 21.3% of the participants, where 42.4% of the students who suffered from any form of depression had an unmet need for depression. The age group of <20 years, non-healthcare college students, hostlers, and daily smokers had significantly higher unmet needs of depression.

Conclusion: The prevalence of depression was high among university students and nearly half of the needs of their depression were unmet. Hence, we recommend screening of depression among university students at entry-level and subsequent screening every year to look for depression and its unmet needs.

Keywords: Unmet needs, Depression, University students, Predictors.

Citation: Thirunavukkarasu A, Arumugam B, Alanazi KS, Alajaj IY, Alrashed FKS, Alsirhani AIE, Alfayyadh HAA. Unmet Needs of Depression among University Students: A Northern Saudi Cross-Sectional Study. JUMJ, December 1, 2018; 5(4): 17 - 26.

Introduction

The World Health Organization (WHO) stated that good mental health is an essential component to achieve health for all

(1). Sound mental health is not merely

an absence of mental illness. WHO stated, it is associated with the psychological and mental wellbeing of a person, which is a fundamental component of the definition of health

(2). A positive mental and

psychological wellbeing will empower the public to understand their potential and handle day to day stress. Hence, they can

be a part of a productive workforce for their families and communities

(3).

Unfortunately, the burden of mental health illness is on the rise all over the world. Disorders of mental health are highly prevalent all over the world affects irrespective of all ages and communities, be partly responsible for the increase in the burden of illness and socio-economic consequences. This prevalence is unequally distributed among countries. More than three fourth of mental disorders are prevalent in low- and middle-income group countries, which




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receives only 10% of global mental health resources

(4,5). Mental health disorders

prevalence and estimates are widely varying depends upon in which settings study was done and study period

(6).

Similar to other health components, mental health also affected by a variety of socio-demographic and cultural factors

(4).

According to WHO, 25% of people in the world are affected by some neurological or mental disorders at one point in their lives. Currently, around 450 million people are suffering from aforesaid conditions and they are one of the leading causes of disability and ill-health globally

(7). Mental health conditions are

broadly categorized into anxiety and depressive disorders. Depression is one of the commonest mental health problems affecting all age groups and communities. Depression is characterized by a wide variety of symptoms such as lack of interest in day to day life, persistence feeling of low and so forth. These depressive disorders are classified into mild, moderate or severe, depending upon the symptoms from a person

(6).

In 2015, around 4.3% of the total word’s population, was affected with depression, i.e., about 300 million and labeled as single largest causes of disability (7.5% of all disability per year lived). Untreated depression is a contributor to suicide, which is again a leading cause of death among 15-29-year-old

(7).

In the Kingdom of Saudi Arabia (KSA), mental health disorders are highly common affecting one third to half of the population

(8). This prevalence varies

depends upon in which settings research is conducted. Despite high prevalence among Saudi population, the social stigma persists in Saudi society

(9,10). The KSA

contributes 14% of the global neuropsychiatric burden, which is one of the highest in the world

(11).

A systematic review done by Alibrahim et al

(12) reported that 41% of Saudi

population is affected by depression. A study done

(13) in the Al-Ahsa region of

KSA by Rashed et al., in 2019 found that 8.6% Saudi population is affected by depression which is lower than that reported in other studies in different regions of KSA. Depression among

university students in the KSA was estimated by several studies

(14-17). Most of

the studies found that this depression prevalence is very high among medical students than non- medical students. They have used different self -administered questionnaires like Depression Anxiety and Stress Scales (DASS-21), Beck’s Depression Inventory and Patient Health Questionnaire - 9 (PHQ- 9)

(18-20).

The community needs assessment is a survey process in which met and unmet needs of health-related events are estimated for a given community. It usually involves several steps. Several international organizations have stated community needs assessment is essential for policymaking or changing the existing policy

(21, 22). The impact of the needs

assessment survey done in southern Australia found that needs assessment was useful in planning health-related services

(23). Barry et al have done a

study(24)

in Ireland on community needs and assessment on mental health promotion fond that there is a big gap in perception and need for mental health promotion among rural communities. Beran in 2015 stated that there is a gap in research and literature of chronic health conditions on the needs of the public and needs assessment

(25). He argued that

health care delivery systems are obliged to meet public needs and unless their needs are met, the overall health of the people cannot be improved. Assessment of perceived unmet need for depression as well as its predictors for unmet needs will help us to understand the barrier for help-seeking among depressed university students

(26). Hence, needs assessment is an

important issue in public policy and financing of health and support services

(27). Assessments of need for

depression by assessing their met and unmet needs are essential for effective planning for support services, but from the review of literature, there is little data available on type and acuity of need

(25-27).

Several studies(8,18,19,28)

were aimed to assess the depression among the public as well as among university students in Saudi Arabia by using different tools. But to our knowledge, this is the first study done in the KSA on which extent



2018 2018

depressed students go unmet for their needs. Hence this study was planned to assess the prevalence of depression among students of Jouf University and to determine unmet needs of depression and its predictors among the study population.

Participants and Methods

Study design and setting and ethical approval:

The present study is an analytical cross-sectional study that was conducted among college students of Jouf University, Sakaka, Saudi Arabia. The study was conducted over six months from October 2017 to March 2018. This study proposal was ethically approved by Jouf University Ethical Committee (approval no: 16-3-4/38-39). Students were asked to give informed consents to participate in this study.

Sample size estimation and method:

To the best of our knowledge, there was no study is available in Saudi Arabia that assessed unmet needs of depression among university students. Hence, we have taken a 50% prevalence to get a maximum sample size

(29). The sample size

was calculated using the formula n = (1.96)

2 pq/d

2 where p is the expected

prevalence (50%) and q is 50% (100-50). Taking the precision (d) as 5%, the sample size necessary, with 95% confidence interval (CI), was calculated and rounded up to be 400. A multistage sampling technique was used to select study participants. In this method, firstly two healthcare science colleges (Medicine and Applied Medical Sciences) were randomly selected and secondly two non-healthcare colleges (Arts, and, Computer and Information Sciences) were randomly selected. Hence, each college contributed 100 to the total sample size. Next, the required number of students from each college were selected based on probability proportional to size (PPS) to their academic year levels. These students were selected by using a systematic random sampling method according to their university academic number.

Data collection, categorization of depression and needs assessment of depression:

A self-administered questionnaire consists of three components was given to each of the enrolled participants. Firstly, it inquires about socio-demographic and lifestyle characteristics (age, gender, year of education, college type, mean sleeping hours per day, residential status, smoking status, and energy drinks intake). The second part consists of the Patient Health Questionnaire-9 (PHQ-9). PHQ-9 is a standard and validated tool that is used to screen, diagnose and measure depression severity. It has been used in a variety of settings including, primary care and research in Saudi Arabia as well as other parts of the world

(20,30,31). Some of the

authors(30)

stated that PHQ-9 is the first choice as a research tool to assess depression. PHQ-9 is Likert's scale response questions consist of 9 items of Diagnostic and Statistical Manual of Mental Disorders-IV criteria. Participants were asked to respond to their feeling in each item over the last two weeks.

Figure 1: Depression needs assessment flow chart.

Each item response in PHQ-9 was scored “0" for not at all, "1" for several days, "2" for more than half the days and "3" for nearly every day. Scores of all 9 items were summed to get a final score (ranges from 0 to 27) and participants were classified according to their score of depression as follows: 0 to 4 as None, 5 to 9 as mild, 10 to 14 as moderate, 15 to 19 as moderately severe and 20 to 27 as severe. The final part of the questionnaire inquired about currently depressed students who are going for any listed



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recommendation for their depression symptoms. This list is prepared as per the national HIV curriculum (NHIVC) criteria

(31). The NHIVC criteria a valid

and reliable tool to assess the need for the management of people screened for depression by PHQ-9

(32). Unmet needs are

defined as “Individual has any form of depression, for which they are not receiving appropriate assistance as per NHIVC criteria. If they receive appropriate assistance, their needs are met for depression (Figure 1).

Data analysis:

The data were expressed as frequency and percentage. Chi-Square test was performed to identify risk factors of depression and logistic regression analysis was done to identify risk factors of unmet needs. These risk factors were considered as predictors. In the analysis using logistic regression, odds ratios (ORs) with 95%

Confidence Intervals (CIs) were calculated. A confidence interval that did not include null value of one and a p <0.05 were considered as statistically significant. Analyses were performed using Statistical Package for Social Sciences (SPSS) Version 20. All the statistical tests applied in this research were two-tailed.

Results

The present study was conducted among students in healthcare college and non-healthcare colleges of Jouf University. Among 400 participants studied, 50.8% were males, 40% belonged to the age group of 20 to 23, 81.2% were living with family, and, 10.2% of people were daily smokers. Nearly two-thirds (67.3%) of the study population sleep less than 7 hours per day (Table 1).

Table 1: Socio-demographic and lifestyle characteristics of the participants (n = 400). Data shown

are mean ± SD and frequincies; n and %. Characteristics n %

Age, Years (21.6 ± 2.8)

<20

20 to 23

>23

113

160

127

28.3

40

31.7

Gender Male Female

203 197

50.8 49.2

Year of education

1st year

2nd year ≥3rd year

121

89 190

30.3

22.2 47.5

College Non-healthcare

Healthcare

200

200

50

50

Mean sleeping duration/day <7 hours

>7 hours

269

131

67.3

32.7

Residential status Hostler

Living with family

75

325

18.8

81.2

Smoking status Daily

Rarely Never

41

34 325

10.2

8.5 81.3

Energy drink intake Daily

Rarely

Never

98

52

250

24.5

13.0

62.5

Frequency of exercise <1 day/week

2 to 3 days/week

>3 days/week

109

207

84

27.3

51.7

21.0

Table 2 presents the prevalence of depression and distribution in each category. Of the 400-sample studied, 85 (21.3%) participants were diagnosed to have some form of depression as screened by PHQ-9 questionnaire. Depression prevalence was significantly higher among male gender, 1

st-year students,

students sleeping less than 7 hours per

day, daily smokers and those who exercise <1 day per week.

Further analysis was done among the 85 people who were depressed to looks for unmet and met the needs of depression. In the present study 36 students (42.4%) from the total of those suffered from any form of depression had an unmet need for depression (Table 3).



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Table 2: Prevalence of depression among the study participants as per PHQ-9 questionnaire (n =

400). Data shown are frequincies; n (%) and p value of Chi-Squire test. Characteristics Total

n

Depression

positive

(n = 85)

Depression

Negative

(n = 315)

p

Age group (in years)

<20

20-23

>23

113

160

127

31 (27.4)

29 (18.1)

25 (19.7)

82 (72.6)

131 (81.9)

102 (80.3)

0.157

Gender

Male

Female

203

197

55 (27.1%)

30 (15.2%)

148 (72.9%)

167 (84.8%)

0.007

Year of education 1st year

2nd year >3rd year

121

89 190

40 (33.1)

14 (15.7) 31 (16.3)

81 (66.9)

75 (84.3) 159 (83.7)

<0.001

College Type

Non-healthcare

Healthcare

200

200

36 (18)

49(24.5)

164 (82)

151 (75.5)

0.114

Mean sleep duration/day <7 hours > 7 hours

269 131

72 (26.8) 13 (9.9)

197 (73.2) 118 (90.1)

<0.001


Living with family

75

325

20 (26.7)

65 (18.8)

55 (73.3)

260 (81.2)

0.203

Smoking status

Daily

Rarely

Never

41

34

325

18 (43.9)

10 (29.4)

57 (17.5)

23 (56.1)

24 (70.6)

268 (82.5)

<0.001

Energy drink intake

Daily Rarely

Never

98 52

250

28 (28.6) 11 (21.1)

46 (18.4)

70 (71.4) 41 (78.9)

204 (81.6)

0.113

Frequency of exercise

<1 day/week 2-3 days/week

>3 days/week

109 207

84

39 (35.8) 38 (18.4)

8 (9.5)

70 (64.2) 169 (81.6)

76 (90.5)

<0.001

Table 3: Prevalence of Met (57.6%)/Unmet (42.4%) needs of depression as per PHQ-9

questionnaire and NHIVC Criteria. Data shown are frequincies; n (%). Characteristics Depressed

(n = 85)

Unmet need

(n = 36)

Met need

(n = 49)

Age group (in years)

<20

20 to 23 >23

31

29 25

18 (58.1)

12 (41.4) 6 (24.0)

13 (41.9)

17 (58.6) 19 (76.0)

Gender Male

Female

55

30

28 (50.9)

8 (26.7)

27 (49.1)

22 (73.3)

Year of education 1st year 2nd year

≥3rd year

40 14

31

21 (52.5) 6 (42.9)

9 (29)

19 (47.5) 8 (57.1)

22 (71)

College Type Non-healthcare

Healthcare

36

49

20 (55.6)

16 (32.7)

16 (44.4)

33 (67.3)

Mean sleep duration/day <7 hours

>7 hours

62

23

30 (48.4)

6 (26.1)

32 (51.6)

17 (73.9)


Living with family

24

61

15 (62.5)

21 (34.4)

9 (37.5)

40 (65.6)

Smoking status Daily

Rarely

Never

18

10

57

13 (72.2)

6 (60.0)

17 (29.8)

5 (27.8)

4 (40.0)

40 (70.2)

Energy drink intake Daily Rarely

Never

31 11

43

17 (54.8) 6 (54.5)

13 (30.2)

14 (45.2) 5 (45.5)

30 (69.8)

Frequency of exercise <1 day / week 2 to 3 days/week

>3 days /week

39 38

8

21 (53.8) 13 (34.2)

2 (25.0)

18 (46.2) 25 (65.8)

6 (75.0)

An attempt was made to identify predictors of unmet needs of depression by using both univariate and multivariate analysis; the same is presented in Tables 4

and 5. The univariate analysis revealed, among the participants who were positive for any depression category, age group of less than 20, male gender, non-healthcare



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college students, hostlers, daily smokers, and daily energy drink consumers were significantly having more unmet needs of depression. Characteristics continued to

be significant in multivariate analysis are the age group of less than 20, non-healthcare college students, hostlers, and daily smokers.

Table 4: Univariate analysis for detection of risk factors of unmet needs of depression among

participants with depression as per NHIVC Criteria. Data shown are frequency (n), Odds ratio at

95% CI (OR) and p value. Characteristics Total

(n = 85)

With unmet

needs (n = 36)

OR P

Age group

(in years)

>23 (Ref)

20 to 23 <20

25

29 31

6

12 18

1.94 (0.69 - 5.58)

4.26(1.37 - 14.66)

0.211

0.012

Gender Female (Ref)

Male

30

55

8

28

2.87 (1.08 - 7.78) 0.033

Year of education

≥3rd year (Ref) 2nd year

1st year

31 14

40

9 6

21

1.46 (0.42 - 5.31) 2.66 (0.99 -7.29)

0.553 0.052

College

Type

Healthcare colleges (Ref)

Non-healthcare

49

36

16

20

2.56 (1.05 - 6.33) 0.039

Mean sleep

duration/day

>7 hours (Ref)

<7 hours

23

62

6

30

0.83 (0.25 - 2.73) 0.767

Residential status

Living with family (Ref) Hostler

65 20

21 15

6.13(2.01 - 9.61) 0.001

Smoking status

Never (Ref) Rarely

Daily

57 10

18

17 6

13

1.69 (0.30 - 9.35) 5.95 (3.87 - 7.86)

0.540 0.002

Energy

drink intake

Never (Ref)

Rarely

Daily

43

11

31

13

6

17

1.28 (0.29 - 5.45)

3.84 (1.49 - 10.76)

0.736

0.007

Frequency

of exercise

>3 days/week (Ref)

2 to 3 days/week <1 day/week

8

38 39

2

13 21

2.72 (0.88 - 5.71)

3.41 (0.63 - 7.19)

0.091

0.163

Discussion

World health day is celebrated by the

WHO on 7th

April of every year with a

special theme that is related to the major

public health problem. WHO declared

world health day theme of the year 2017

as “Depression: Let’s talk”(32)

. Several

campaigns and prevention activities were

done all over the world for the prevention

of depressive disorders. Even world

mental health day of 2019 theme was

focused on suicide prevention which is

one of the major consequences of

depression(33)

. This very recent theme by

the WHO emphasizes that depression is a

major public health problem worldwide

and the need for its prevention through

several modalities. This can be achieved

not only by assessing the magnitude of

depression but also by assessing unmet

needs for depression. Our present study

was aimed to assess the prevalence of

depression, unmet needs for depression

and its predictors among Jouf university

students, Sakaka, Saudi Arabia.

The present study found that 21.3% of participants were affected by some type of depression. This finding is similar to a study done among university students of Turkey by Bayram and Bilgel

(34) as well

as some studies done among university students in Saudi Arabia

(11,12, 14). The

prevalence of depression in the aforementioned studies varies from 20.5% to 27.1%. In contrast to our present study, a study done

in Malaysia by Nahas

et al(35)

in 2019 found that 36.4% of students from the public university had suffered from some form of depression. This difference may be due to socio-cultural factors that are different from our study settings as still, stigma plays a major role in reporting symptoms related



2018 2018

to mental health issues that are present among Saudi population.

In our study, we found that 24.5% of

healthcare colleges' students of Jouf

University were suffering from depression

and 18% of non-healthcare colleges'

students were suffering from depression.

This is consistent with several studies

done in Saudi Arabia(8, 12, 15)

. A study was

done by Saud et al(36)

in 2016 found that

28.3% of students were screened positive

for depression. In contrast to our study,

another study done by Talal et al in 2017

found very low rate of 10.5% of medical

college students of Majmah University,

Saudi Arabia had suffered from

depression(16)

. This striking difference is

most likely due to the tool that they have

used for their study; the General Health

Questionnaire-28 (GHQ-28). GHQ-28 is a

self-administered questionnaire that is

used to screen current mental health

disorder. GHQ-28 screens only severe

depressive symptoms. Hence prevalence

was low in their study(37)

.

Table 5: Multivariate analysis for detection of risk factors (predictors) of unmet needs of

depression among participants with depression as per NHIVC Criteria. Data shown are frequency

(n), Odds ratio at 95% CI (OR) and p value. Characteristics Total

(n = 85)

With unmet

needs (n = 36)

OR P

Age group

(in years)

>23 (Ref)

20 to 23

<20

25

29

31

6

12

18

1.87 (0.79 – 3.19)

3.40(1.64 – 7.12)

0.316

0.042

Gender Female (Ref) Male

30 55

8 28

2.64 (0.97 – 5.23) 0.058

Year of

education

≥3rd year (Ref)

2nd year

1st year

31

14 40

9

6 21

1.52 (0.64 – 4.91)

2.33 (0.86 -7.08)

0.381

0.073

College Type Healthcare (Ref) Non healthcare

49 36

16 20

2.476 (1.01 – 6.28) 0.043

Mean sleep

duration/day

>7 hours (Ref)

<7 hours

13

62

6

30

0.88 (0.31 – 2.43) 0.749

Residential status

Living with family (Ref) Hostler

65 20

21 15

5.13 (2.47 – 7.81) 0.007

Smoking

status

Never (Ref)

Rarely Daily

57

10 18

17

6 13

2.16 (0.69 – 5.64

4.79 (3.19 – 7.54)

0.098

0.004

Energy drink

intake

Never (Ref)

Rarely Daily

43

11 31

13

6 17

1.28 (0.29-5.45)

1.79 (0.94 – 8.64)

0.736

0.063

Frequency of

exercise

>3 days/week(Ref)

2 to 3 days/week

<1 day/week

8

38

39

2

13

21

3.12 (0.75 – 4.37)

2.95 (0.91 – 5.60)

0.087

0.093

The present study found that the depression was significantly higher among the students who sleep <7 hours/day (p<0.001). Consistent with our results, a study done by Saud et al in Saudi Arabia showed that depression was significantly (p<0.05) higher among the students who sleep less hours per day

(36).

The present study also found male gender, daily smokers and hostlers are more prone to get depression than others.

In this study, 42.4% of students who were diagnosed to have depression had an unmet need for their depressive symptoms. In contrast to our study, a

study done in USA by Mojtabai et al(26)

reported that 31.9% of university students had an unmet need for their depression and its treatment. High prevalence in our study is most probably contributed by the stigma associated with mental health disorders in Saudi Arabia. Hence, depressed people may not seek help for their symptoms at early stage. These perceived barriers to seek help may lead to the diagnosis of depression at a late stage that associates with long-term complications of depression.

After adjustment with other variables through multivariate analysis, our study



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found that age group of <20 years, non-healthcare college students, hostlers, and daily smokers have significantly higher unmet needs of depression. These findings are consistent with studies done by Mojtabai et al and Stewert

(26,38). They

also reported that a young age and other substance abusers such as smoking are important predictors of unmet need for depression. Greden

(39) had found in his

study that patients with other associated diseases reported having more unmet needs

Conclusion

The prevalence of depression is high among university students. Nearly half of the needs of their depression are unmet. The age group of <20 years, non-healthcare college students, hostlers, and daily smokers had significantly higher unmet needs of depression. Hence, we recommend screening of depression among all university students at entry-level and subsequent screening every year to look for depression and its unmet needs. Regular health education campaigns on depression and other mental health disorders need to be done to increase awareness and decrease the stigma of depression so that they seek help without any hindrance. These predictors can also be used to plan healthcare services related to mental health in other universities of KSA.


Despite the best effort made to assess the depression and its unmet needs by the authors by using standard methodology and adequate sample size, some limitations exist for this study. Firstly, this cross-sectional study found only the association between outcome and risk factors, not the direction of the association. Secondly, recall bias, exaggerated responses and social desirability to participate in this study from the students also to be considered while interpreting the results.

Funding

This study was funded by Jouf University as a part of the employment duties of the authors.



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3. Fekete C, Siegrist J, Post MWM, Brinkhof MWG; SwiSCI Study Group. Productive activities, mental health and quality of life in disability: Exploring the role enhancement and the role strain hypotheses. BMC Psychol., 2019; 7(1):1.

4. Jacob KS, Patel V. Classification of mental disorders: A global mental health perspective. The Lancet, 2014; 383(9926):1433-5.

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6. National Collaborating Centre for Mental Health (UK). Depression: The treatment and management of depression in adults (Updated Edition). Leicester (UK): British Psychological Society; 2010. (NICE Clinical Guidelines, No. 90.) Appendix 11, the classification of depression and depression rating scales/questionnaires. Available from: https://www.ncbi.nlm.nih.gov/books/NBK63740/

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8. Almutairi AF. Mental illness in Saudi Arabia: An overview. Psychology Research and Behavior Management, 2015; 8:47-9.

9. Alamri Y. Mental illness in Saudi Arabia: Stigma and acceptability. International J. Social Psychiatry, 2016; 62(3):306-7.

10. Alyousef SM. Interventions recommended to combat a stigma of mental health problems to access mental health care services in Saudi Arabia. IIMHS, 2017; 7(4):36-42.

11. Mental Health Atlas - Department of Mental Health and Substance Abuse, World Health Organization; 2011 (cited 2019 Nov 12). Available from: https://www.who.int/mental_health/evidence/atlas/profiles/sau_mh_profile.pdf?ua=1



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12. Alibrahim OA, Al-Sadat N, Elawad NA. Gender and risk of depression in Saudi Arabia, a systematic review and meta-analysis. J. Public Health in Africa, 2010; 1(1):e7.

13. Rashed ASA, Al-Naim AF, Almulhim BJ, Alhaddad MS, Al-Thafar AI, Alali MJ, et al. Prevalence and associated factors of depression among general population in Al-Ahsa, Kingdom of Saudi Arabia: A community-based survey. Neurology, Psychiatry and Brain Research, 2019;31:32-6.

14. Madkhali JM, Hakami AA, Dallak AH, Hakami RM, Yatimi AA, Hamdi ME, et al. Prevalence and associated factors of depression among patients with diabetes at Jazan Province, Saudi Arabia: A Cross-Sectional Study. Psychiatry J., 2019; 2019:6160927.

15. Alharbi H, Almalki A, Alabdan F, Hadad B. Depression among medical students in Saudi medical colleges: A cross-sectional study. Advances in Medical Education and Practice, 2018; 9:887-91.

16. Talal A, Tahir A, Fahad F, Mansour Z, Mohammed M, Waqas S et al. Prevalence of mental distress among undergraduate medical students at Majmaah University, Kingdom of Saudi Arabia. Majmaah J Heal Sci., 2017; 5(2):66-75.

17. AlFaris E, Irfan F, Amin HS, Qureshi R, AlMaflehi N, Batais MA, et al. The prevalence rate and associations of depressive symptoms and smoking among applied medical science students in a large university in Saudi Arabia: A cross-sectional study. J Nat Sci Med., 2019; 2:237-43.

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28. Al-Maharbi S, Abolkhair AB, Al Ghamdi H, Haddara M, Tolba Y, El Kabbani A, et al. Prevalence of depression and its association with socio-demographic factors in patients with chronic pain: A cross-sectional study in a tertiary care hospital in Saudi Arabia. Saudi J. Anaesthesia, 2018; 12(3):419-25.

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36. Saud AS, Abdulaziz AA, Shahad AS, Amjad AS, Hosam MS, Nuha MA, et al. Prevalence of depression among medical students at Taibah University, Madinah, Saudi Arabia. Int J of Acad Sci Res., 2016; 4(1): 93-102.

37. Shayan Z, Pourmovahed Z, Najafipour F, Abdoli AM, Mohebpour F, Najafipour S.

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Salem & Mohamed - The use of an Electronic Augmentative Communication Device to …..


2018 2018

Original Article

The use of an Electronic Augmentative Communication Device to assess the needs of Mechanically Ventilated

Patients in Critical Care

Aziza M. Salem1*

, Nagwa M. A. Mohamed1,2

1University College of Umluj, University of Tabuk, Tabuk, Saudi Arabia.

2Department

of Medical Surgical Nursing, Faculty of Nursing, Assiut University, Assiut, Egypt. *Corresponding author: [email protected]

Abstract

Background: Mutual communication among critical care nurses and patients is a basic part of patient care. Effective communication is as an important vehicle to convey patients‟ needs and the feedback decisions and interventions.

Objective: Our aim was to identify the invasive mechanical ventilated (IMV) patients‟ needs through using electronic augmentative and alternative communication (AAC) device ("Be My Voice") during IMV period.

Patients and Methods: A total of 74 patients participated in this study. The study was conducted in four hospitals at Amman, Jordan. During the study, IMV patients used I pad to communicate their needs to ICU nurses. All their communication trails were saved on these I pads for further analysis by researcher.

Results: Most of IMV patients experience pain, breathing difficulties and other distressing symptoms during being placed on invasive mechanical ventilation. "Be My Voice" is one nurse-patient communication applications, which was used to uncover the needs of patients on IMV. As a result, critical care nurses were able to fulfill these needs.

Conclusion: Enhancing communication with IMV patients can lead to appropriate symptom management and the fulfillment of patients‟ needs.

Key words: Critical care, Invasive mechanical ventilation, Electronic augmentative and alternative communication, Communication strategies, Intensive care, Nursing.

Citation: Salem AM, Mohamed NMA. The use of an Electronic Augmentative Communication Device to assess the needs of Mechanically Ventilated Patients in Critical Care. JUMJ, December 1, 2018; 5(4): 27 - 32.

Introduction

Inability to communicate verbally associated with many problems during invasive mechanical ventilation (IMV) period

(1). Patients who require IMV suffer

from discomfort due to the endotracheal tube and communication difficulties, which are significant causes of anxiety

(2).

More than one-third of communicative attempts between nonverbal intensive care unit (ICU) patients and their nurses (to express the pain they were experiences) were found to be unsuccessful

(1). Failed

communication attempts between patients and health care providers could result in experiencing pain that is not being appropriately assessed or managed

(3).

The communication abilities of IMV patients could be significantly enhanced through augmentative and alternative communication (AAC) that could become the means for increased efficiency and speed of communication. Augmentative and alternative communication has been in use since 1975 to help IMV patients communicate

(4). However, a few studies

have addressed its effects on patient outcomes in ICU

(5). There is a wide range

of communication aids from basic to high technology, but the selection of the most effective, efficient, and safe method should be based on a patient‟s clinical condition. There are several studies supporting the use of AAC to enhance communication with non-speaking



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patients in order to alleviate their frustration and ensure their needs are met

(5,6,7).

ICU nurses state that their communication with intubated patients is based on observing senior nurses or trial-and-error

(8). Therefore, ICU nurses report

feeling frustrated due to communication difficulties with IMV patients, and actually attempt to avoid patients with communication problems

(9). Thus, it

seems that ICU nurses need comprehensive training and educational support to maintain effective and efficient communication with IMV patients. Furthermore, the Joint Commission International Accreditation (JCIA) consider the effective communication as a requirement for patient safety

(10).

A number of articles address the lack of use of augmentative and alternative communication (AAC) systems in ICU

(6,8,9,11). Therefore, the effects of AAC

implementation are not adequately investigated. Sharing information among nurses and patients is an essential part of patient care. However, in the Arabic region there are no protocols in ICUs regarding communication with IMV patient. Thus, the main purpose of this study was to identify IMV patients‟ needs while using electronic AAC device during IMV period. The solicited data can be considered as baseline study in the field of communication with IMV patients.

Patients and Methods

Design and Setting

The descriptive design was used in view of its benefit in obtaining empirical information that addresses the most common needs among IMV patients while using electronic AAC. In this study, IMV patients were defined as patients with invasive (endotracheal or Tracheostomy tube) and connected to mechanical ventilator regardless of their mode of ventilation (control, SIMV, ect.). Before introducing AAC devices to patients, training for nurses on about the importance of communication with IMV patients and how to run electronic AAC device was conducted. Nurses' training was done by the researcher during the in-service education time, and once any IMV

patient met the selection criteria, an enforcement training session was conducted to the assigned nurse by the charge nurse at that shift. The charge nurses at the selected hospitals attended a training workshop about the application (BE MY VOICE) for 4 hours that was conducted by the researcher.

The researcher asked all ICU nurses to stop using an electronic AAC device when IMV patient has a need that must be fulfilled immediately, and, at any time IMV patient showed no interest in communication using an electronic AAC.

The study was conveniently conducted in four hospitals in Amman, Jordan. from March until July 2017. The selected hospitals were chosen because they had the largest ICUs with high occupancy rate. There were no available communication assistive devices in these hospitals during the pre-intervention phase. Institutional review board at the University of Jordan approved the study that was also approved by Bioethical Committees at each of the four hospitals where the study was conducted.

Files of patients admitted to ICU were retrieved with the help of the medical records officials through referencing them using their medical numbers. The target population of this study was all IMV patients. We reviewed the records of patients fulfilling the inclusion criteria among those placed on IMV for at least 24 hours. Patients aged ≥18 years, and patients who were able to move the upper arm and had intact visual ability (i.e., they are able to touch the electronic AAC screen) were voluntarily enrolled. Exclusion criteria included unconscious patients, those under deep sedation (with a score of -3 or -4 on the Richmond Agitation and Sedation Score), and those or their custodians were unwilling for participation.

The Intervention and Procedure

An electronic AAC, named „Be My Voice‟ was the study intervention, which was fully described in previous paper

(12).

IMV patients‟ needs that are integrated in that application included basic physiological needs such as, eating, drinking and toiletings. In addition, they



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include the need for nursing care as (suctioning, positioning and bathing), and, the patients social needs. Other functions can be used to report IMV patients subjective symptoms such as, dyspnea, feeling cold or hot and fatigue. A professional computer programmer was hired to place "Be My Voice" application on Android tablet. All functions accessible for use were included in touch selection of graphic buttons with pre-made spoken messages representing patients‟ symptoms or needs, in addition to a typewriting on-screen keyboard. It was instructed in Arabic phrases along with an integrated picture format to enhance the patients‟ communication abilities. The pateints' legal guardian were interviewed to ensure informed consent collection before enrolment.

The mean number of communication acts within communication exchanges per 24 hrs using the electronic AAC device was 12, where the total fequencies of using an electronic AAC ranged from 8 to 240 times.

Statistical Analysis Methods

Descriptive statistics were used for patient‟s demographics using mean ± SD, and frequency; n (%). And for the patients‟ needs, data were shown as frequency; n (%).

Results & Discussion

A total of 74 IMV patients participated in this study as described in Figure 1. Table 1 provides the demographic information about the study sample.

Most common needs when using the AAC device

Study findings demonstrate the first most reported IMV patient need which was feeling pain (99%). This was consistent with the Rodriguez et al (2016)

(13) stating

that patients want to communicate their feeling of pain to ICU nurses. In another study by Alasad et al (2015)

(9) conducted

on 98 ICU patients in three hospitals in Jordan, reported that 58% of patients have pain during their ICU stay. One explanation for unsuccessful pain expression may be related to the fact that ICU nurses‟ interpreted patient‟s facial expression as a measure of pain rather than using self-expression of pain among

IMV patients. This indicates the insufficiency of pain assessment among IMV patients. For that, Azzam and Alma‟s (2013)

(14) recommended using

several standardized visual pain intensity assessment tools for IMV patients, such as the Numeric Rating Scale and the Faces Pain Scale, to assess pain in acutely/critically ill adults who are responsive and unable to speak.

Figure 1: Consort flow diagram of the study (n = 74).

Table 1: Patients' characteristics (n = 74). Data shown are mean ± SD, and frequency; n (%).

Variables Mean ± SD or n (%)

Age, Years 56.28 ± 17.76

Gender Male 50 (67.6)

Female 24 (32.4)

Diagnosis

Medical 28 (37.8)

Surgical 14 (18.9)

Oncology 32 (43.2)

Communication acts per 24 hrs using an electronic AAC

12 ± 11.16

Our study revealed that feeling thirsty is the second highest ranked sensation (61%) among IMV patients which is consistent with Arai et al (2013)

(15)

addressing thirst as a common phenomenon in ICU. Furthermore, another study reported patients experiences of being conscious with IMV using a qualitative approach; within one patient described his thirst by saying, „I



2018 2018

dreamt of getting a mouthful of water‟(16)

. Among IMV patient, thirst is a need that could not be fulfilled because of the presence of endotracheal tube

(17).

In Jordanian culture, there are strong social bonds between families where everyone supports the other in times of need. Moreover, visiting hospitalized patients is considered as social duty by their relatives and friends. In the current study, about 38% of IMV patients asked to see their families. It was obvious that IMV patients may perceive their comfort and support from their family members by their company in ICU setting. Arabs value preserving family unity

(18). However,

most of the selected hospitals had restricted family visiting hours especially for critical care units.

The current study findings highlighted that the 3

rd most reported needs by IMV

patients were asking for a change of position (37%), changing the level of the bed head (31%), and suction (35%). It is well-documented in the literature that IMV patients feel suffocated, and most IMV patients reported discomfort due to secretions from their mouth

(16,17,19). IMV

patients reporting dyspnea in the present study matches the findings of Karlsson et al (2012)

(20) in that IMV patients

constantly reported difficulties in breathing. However, the previous literature did not rank IMV patients‟ needs or wants, as most of the literature only described patients recalled memories

of being connected to IMV in ICUs using qualitative approach retrospectively

(19-21).

As a majority in Jordan, Muslims believe that illness and cure is God's willing, and reciting the Holy Quran can be used as mediation to cure illness. For this reason, in the current study, 31% of IMV patients asked to listen to Quran. Religious beliefs are superior during illness, especially among the critical illness

(21). Meeting the

religious demands of IMV patients are of great importance. In view of this, precise assessment of IMV patients‟ spiritual needs could enhance effective spiritual care

(22). The low ranked needs were bed

bath (8%), to see a religious figure (10%) and to listen to music (12%). The low rank of a need may give an impression that some physical, social, emotional and spiritual needs in the selected hospitals have been matched to a high degree which could reflect a good quality of patient‟s care. Furthermore, the practice to see a religious figure is not common among Muslims and can be replaced by listening to Quran.

The lowest ranked feeling among IMV patients in the current study was feeling anxiety (7%). This result was contradictory to literature about anxiety experience among ICU patients

(23,24). The

rationale for low anxiety reporting in the current study may be due to the timing of data collection, which was only 24 hours after using electronic AAC. All IMV patients' needs are shown in Figure 2.

Figure 2: Invasive mechanical ventilation patients‟ needs during 1st 24 hours of using electronic augmentative and alternative communication. Data shown are frequency; n.



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Time management in a patient with complex needs and life-threatening situations is a paramount aspect of critical care nursing. One ICU nurse mentioned, “What the patient need is just to touch the icon, then easily we can know what he wants.” For this reason, many ICU nurses mentioned that the electronic AAC improved the quality of nursing care in ICU. ICU nurses used the time saved by not having to guess patient needs, which are easily identified using electronic AAC, to actually fulfill them. Another ICU nurse mentioned that, “using „Be My Voice‟ helped me to assess the patient pain by giving a full description of pain which helped to manage his pain appropriately, & in short period of time”.

The findings of this study demonstrated the effectiveness of using the "Be My Voice" application installed on an AAC device to ease the communication between ICU nurses and IMV patients. This method helped unveil the patients‟ needs and nurses‟ reactions to patients using the application, and found more satisfaction and cooperation with nursing care. However, these results should be considered within limitations of the study.

Conclusion

Effective communication is recognized as a priority across the healthcare continuum, especially when the patient becomes speechless. The key finding of this study is the demonstrated effectiveness of using an electronic AAC device to facilitate IMV patient-nurse communication. The current study provides satisfactory evidence to show that most IMV patients experience pain, breathing difficulties and other distressing complaints. These problems were not properly dealt with previously because of being non-verbal during IMV use. Enhancing communication with IMV patients can lead to appropriate problems management and the fulfillment of patients‟ needs. However, the results showed that there were still some challenges in communicating with IMV patients, especially when these patients are unable to use electronic AAC devices. The future of AAC devices looks bright by virtue of continuing research into its effect on patient outcomes.


The study is considered as baseline investigation for IMV patients‟ needs. Thus, a convenience sample was recruited with no randomization for the study intervention. In addition, low response rate as some IMV patients were unable to utilize the electronic AAC devices due to computer illiteracy which can be considered as another limitation for this study.

Funding

The study was funded by the authors' institutions as a part of their employment duties.



References

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2. Khalaila R, Zbidat W, Anwar K, Bayya A, Linton DM, Sviri S. Communication difficulties and psychoemotional distress in patients receiving mechanical ventilation. Am. J. Critical Care, 2011; 20(6):470-9.

3. Wilson-Stronks A, Blackstone SW. Taking collective action to improve patient-provider communication. Perspective on Augmentative and Alternative Communication, 2013; 22(2): 69-78.

4. El-Soussi A, Elshafey M, Othman S, Abed-Elkader F. Augmented alternative communication methods in intubated COPD patients: Does it make difference. The Egyptian Society of Chest Diseases and Tuberculosis, 2015; 64: 21-28.

5. Hoorn S, Elbers P, Tuinman P. Communicating with conscious and mechanically ventilated critically ill patients: a systematic review. Critical Care, 2016; 20(1):333; 1-14.

6. Costello JM, Patak L, Pritchard J. Communication vulnerable patients in the pediatric ICU: Enhancing care through augmentative and alternative communication. Journal of Pediatric Rehabilitation Medicine: An Interdisciplinary Approach, 2010; 3(4):289-301.

7. Grossbach I, Stranberg S, Chlan L. Promoting effective communication for patients receiving mechanical ventilation. Critical Care Nurse, 2011;31(3):46-60.



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8. Radtke JV, Tate JA, Happ MB. Nurses‟ perceptions of communication training in the ICU. Intensive and Critical Care Nursing, 2012; 28(1):16-25.

9. Alasad J, Abu Taber N, Ahmad M. Patients' experience of being in intensive care units. Journal of critical care, 2015; ;30(4):859.e7-11.

10. JCI. International Patient Safety Goals. 2016; http://www.jointcommissioninternational.org/improve/international-patient-safety-goals/ (accessed December 20, 2017).

11. McNaugton D, Light J. What We Write about When We Write About AAC: The Past 30 Years of Research and Future Directions. Augmentative and Alternative Communication, 2015; 31(4): 261-270.

12. Salem A, Ahmad M. "BE MY VOICE" placed on augmentative and alternative communication device. International Journal of Applied and Natural Sciences, 2018; 7(2): 1-10.

13. Rodriguez CS, Rowe M, Thomas L, Shuster J, Koeppel B, Cairns P. Enhancing the Communication of Suddenly Speechless Critical Care Patients, American Journal of Critical Care, (2016); 25(3): e40-e47.

14. Azzam PN, Alam A. Pain in the ICU: a psychiatric perspective. Journal of intensive care medicine, (013; 28(3): 140-150.

15. Arai S, Stotts N, Puntillo K. Thirst in critically ill patients: from physiology to sensation. American Journal of Critical Care, 2013; 22: 328-335.

16. Holm A, Dreyer P. Intensive care unit patients‟ experience of being conscious during endotracheal intubation and mechanical ventilation. Nurs Crit Care, 2017;22(2):81-88.

17. Alguindy A, Mohamed W, Gado A. Personal Lived Experience of Mechanically Ventilated Patients during the Recovery Period after Open-Heart Surgery at El Manial University Hospital. Journal of Biology, Agriculture and Healthcare, 2014; 4(24): 61-79.

18. Fateel E, O'Neill C. Family members‟ involvement in the care of critically ill patients in two intensive care units in an acute hospital in Bahrain: The experiences and perspectives of family members‟ and nurses‟ - A qualitative study. Clinical Nursing Studies, 2016; 4(1): 57-69.

19. Merilainen M, Kyngas H, Ala-Kokko T. Patients‟ interactions in an intensive care unit and their memories of intensive care: A mixed method study. Intensive and Critical Care Nursing, (013; 29(2): 78-87.

20. Karlsson V, Bergbom I, Forsberg A. The lived experiences of adult intensive care patients who were conscious during mechanical ventilation: A phenomenological-hermeneutic study. Intensive and Critical Care Nursing, 2012; 28(1): 6-15.

21. Loghmani L, Borhani F, Abbaszadeh A. Factors Affecting the Nurse-Patients‟ Family Communication in Intensive Care Unit of Kerman: a Qualitative Study. Journal of Caring Sciences, 2014; 3(1): 67-82.

22. Abuatiq A. Spiritual Care for Critical Care Patients. International Journal of Nursing & Clinical Practices, 2015; 2:128;1-4.

23. Castillo M, Aitken L, Cooke M. Study protocol: Intensive care anxiety and emotional recovery. Australian Critical Care, 2013; 26(3):142-7.

24. Perpiñá-Galvañ J, Richart-Martínez M. Scales for evaluating self-perceived anxiety levels in patients admitted to intensive care units: a review. American Journal of Critical Care, 2009; 18(6): 571-80.

http://www.jointcommissioninternational.org/improve/international-patient-safety-goals/



JUMJ Comprehensive Instructions for Authors and Reviewers

Jouf University Medical Journal (JUMJ), 2018 September 1; 5(4): 33 – 46.

2018 2018

JUMJ Comprehensive Instructions

For Authors and Reviewers

INTRODUCTION

Types of submission and criteria

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Plagiarism policy of this journal is mainly inspired from the plagiarism policy of The Nature (http://www.nature.com/authors/policies/plagiarism.html) and is summarized as described below:



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2. Plagiarism can be said to have clearly occurred when large chunks of text have been cut-and-pasted. Such manuscripts would not be considered for publication in the journal. Papers with confirmed plagiarisms are rejected immediately.

3. But minor plagiarism without dishonest intent is relatively frequent, for example, when an author reuses parts of an introduction from an earlier paper.

4. Duplicate publication, sometimes called self-plagiarism, occurs when an author reuses substantial parts of his or her own published work without providing the appropriate references. This can range from getting an identical paper published in multiple journals, to 'salami-slicing', where authors add small amounts of new data to a previous paper. Self-plagiarism, also referred to as „text recycling‟, is a topical issue and is currently generating much discussion among editors. Opinions are divided as to how much text overlap with an author‟s own previous publications is acceptable. We normally follow the guidelines given in COPE website. Editors, reviewers and authors are also requested to strictly follow this excellent guideline (Reference: Text Recycling Guidelines: http://publicationethics.org/text-recycling-guidelines).

5. In case of “suspected minor plagiarism”, authors are contacted for clarification. Depending on all these reports, reviewers and editors decide final fate of the manuscript.

6. Use of automated software is helpful to detect the 'copy-paste' problem. All submitted manuscripts are checked by the help of different databases, eTBLAST, Plagiarism Detection tools, etc. At the same time scientific implication of the case ('suspected minor plagiarism'), also judged by reviewers and editors. Plagiarism Detection tools are useful, but they should to be used in tandem with human judgment and discretion for the final conclusion. Therefore, suspected cases of plagiarisms are judged by editors on 'case-to-case basis'.

7. Editors have the final decision power for these cases.

Ethics in publishing

Policy and ethics

The work described in your article must have been carried out in accordance with The Code of Ethics of the World Medical Association (Declaration of Helsinki) for experiments involving humans (http://www.wma.net); Uniform Requirements for manuscripts submitted to Biomedical journals (http://www.icmje.org) published by the International Committee of Medical Journal Editors. An official local authorized body should review the research project before its beginning and a document acknowledging the ethical clearance of the research could be requested from prospective authors. This must be stated at an appropriate point in the article (Material and Methods). Research papers based on animal studies should get a similar ethical clearance from an official committee for the animal welfare.

Cover letter

A cover letter is required to accompany the manuscript submission along with the Manuscript Submission/Copyright Transfer Form. It should include information about the following points relevant to the specific type of your article:

Why should JUMJ publish your manuscript?

Relevance to JUMJ publication policy. Potential competing interests. Approval of the manuscript by all authors. Adherence to Simultaneous and Duplicate

Publication Policy.

Conflict of interest

All authors are requested to disclose any actual or potential conflict of interest including any financial, supplements, personal or other relationships with other people or organizations within three years of beginning the submitted work that could inappropriately influence, or be perceived to influence, their work.

Submission declaration and verification

Submission of an article implies that the work described has not been published previously (except in the form of an abstract or as part of a published lecture or academic thesis or as an electronic preprint), that it is not under consideration for publication elsewhere, that its publication is approved by all authors and by the responsible authorities where the work was carried out, and that, if accepted, it will

http://www.wma.net/

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not be published elsewhere in the same form, in English or in any other language, including electronically without the written consent of the copyright-holder. To verify originality, your article may be checked by an appropriate originality detection service.

Authorship

All authors should have made substantial contributions to all of the following: (1) the conception and design of the study, or acquisition of data, or analysis and interpretation of data, (2) drafting the article or revising it critically for important intellectual content, (3) final approval of the version to be submitted.

Changes to authorship

This policy concerns the addition, deletion, or rearrangement of author names in the authorship of accepted manuscripts before the accepted manuscript is published in an online and/or printed issue.

Requests to add or remove an author, or to rearrange the author names, must be sent to the Journal Manager from the corresponding author of the accepted manuscript and must include: (a) the reason the name should be added or removed, or the author names rearranged and (b) written confirmation (e-mail, fax, letter) from all authors that they agree with the addition, removal or rearrangement.

In the case of addition or removal of authors, this includes confirmation from the author being added or removed.

Requests that are not sent by the corresponding author will be forwarded by the Journal Manager to the corresponding author, who must follow the procedure as described above.

Journal Deputy Editor will inform the Journal Editor-in-Chief of any such requests and publication of the accepted manuscript in an online issue is suspended until authorship has been agreed.

After the accepted manuscript is published in an online and/or printed issue: Any requests to add, delete, or rearrange author names in an article published in an online issue will follow the same policies as noted above and result in a corrigendum.

Role of the funding source

You are requested to identify who provided financial support for the conduct of the research and/or preparation of the article and to briefly describe the role of the sponsor(s), if any, in study design; in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the article

for publication. If the funding source(s) had no such involvement, then this should be stated.

Open access

Once JUMJ is launched as an open access journal, articles are freely available to both subscribers and the wider public with permitted reuse. No Open Access publication fee. All articles published Open Access will be immediately and permanently free for everyone to read, download, distribute and copy the article, and to include in a collective work (such as an anthology), as long as they credit the author(s) and provided they do not alter or modify the article.

The processing and publication fee

No processing or publication fee is required.

Language (usage and editing services)

Please write your text in good English (American or British usage is accepted, but not a mixture of these). Authors who feel their English language manuscript may require editing to eliminate possible grammatical or spelling errors and to conform to correct scientific English may wish to use any English Language Editing service available. The abstract content will be translated into Arabic to accompany the published manuscript as an Arabic Abstract. In case the author's mother language is not Arabic, the Journal will help preparing it.

Submission

Manuscript submission and follow up to this journal proceeds totally online through email communications ([email protected]). Complete manuscript with tables and figures inserted within the text at their final place should be submitted as a single file in the two; word and PDF formats. The submission and copyright transfer form is available on request and is mandatory to hand fill, sign and date by all authors before any processing of the submitted material. The form is provided at the last page of every issue of JUMJ. Authors are encouraged to print and fill the form and submit alongside with the manuscript.

Referees

A minimum of six suitable potential reviewers (please provide their name, email addresses, title, institutional affiliation, and, ORCID or Scopus ID). When compiling this list of potential reviewers please consider the following important criteria: They must be knowledgeable about the manuscript subject area; must not be from your own institution; at least two of the suggested reviewers should be from another country than the authors'; and



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they should not have recent (less than four years) joint publications with any of the authors. However, the final choice of reviewers is at the editors' discretion. Excluding peer reviewers: During submission you may enter details of anyone who you would prefer not to review your manuscript.

Types of submission and criteria

Original Research Communications may be offered as Full Papers or as Short Communications. The latter format is recommended for presenting technical evaluations and short clinical notes, comprising up to 1,500 words of text, 15 references, and two illustrative items (Tables and/or Figures).

Case Reports will be accepted only where they provide novel insight into disease mechanisms, diagnostic, and management applications.

Critical Reviews will be welcome but prospective authors are strongly advised to seek authorization from the Editor-in-Chief to avoid conflict with scheduled reviews invited by the Editorial Board. They should address new topics or trends in fields of the Journal Scope.

Editorial and opinion pieces Please contact the Editor-in-Chief for consideration.

PREPARATION

NEW SUBMISSIONS

Submit your manuscript as a single PDF file and a single Word document file, in any format or layout that can be used by referees to evaluate your manuscript. It should contain high enough quality figures for refereeing.

References

There are no strict requirements on reference formatting at submission. References can be in any style or format as long as the style is consistent. Where applicable, author(s) name(s), chapter title/article title, journal title/book title, year of publication, volume number-issue number/book chapter and the pagination must be present. Use of DOI is highly encouraged. The reference style used by the journal will be applied to the accepted article at the proof stage. Note that missing data will be highlighted at proof stage for the author to correct.

Formatting requirements

On initial submission, there are no strict formatting requirements but all manuscripts must contain the essential elements needed to convey your manuscript message; Title, Abstract, Keywords, Introduction, Materials/Patients and Methods, Results with

Artwork, Figures and Tables with legends and titles (below the figure and on top of the table, respectively), Discussion, Limitations of the study and Future directions, Gain of Knowledge, Conclusions, Conflict of Interest, Acknowledgement (if any), and References. Upon final acceptance, the author(s) will be instructed to reformat their manuscript according to JUMJ format detailed below.

If your article includes any Videos and/or other Supplementary material, this should be included in your initial submission for peer review purposes.

Divide the article into clearly defined sections with title, subtitles and sub-subtitles on separate lines whenever applicable.

Figures and tables embedded in text. Please ensure the figures and the tables included in the single file are placed next to the relevant text in the manuscript.

All standard and non-standard abbreviations should be defined in full at the fist mention in the text and should be consistent throughout the paper.

In the initial submission, it is advisable to have references in names (e.g., Smith et al, 2014) within the text rather than numbering them. Revision and correction frequently necessitate dropping or inserting text with their references. Numbering references in that stage will create the problem of renumbering them is the text and list.

ORIGINAL RESEARCH PAPER WRITING TEMPLATE

Papers include original empirical data that have not been published anywhere earlier or is not under consideration for publication elsewhere (except as an abstract, conference presentation, or as part of a published lecture or academic thesis), and after accepted for publication it will not be submitted for publication anywhere else, in English. Null/negative findings and replication/refutation findings are also welcome. If a submitted study replicates or is very similar to previous work; authors must provide a sound scientific rationale for the submitted work and clearly reference and discuss the existing literature. Submissions that replicate or are derivative of existing work will likely be rejected if authors do not provide adequate justification. Studies, which are carried out to reconfirm/replicate the results of any previously published paper on new samples/subjects (particularly with different environmental and/or ethnic and genetic background) that produces new data-set, may be considered for publication. But these types



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of studies should have a „clear declaration‟ of this matter. The English language in submitted articles must be clear, correct, and unambiguous. No limits for the total number of words for articles of this type.

Title page information

Page 1 of the typescript should be reserved for the title, authors and their affiliation and addresses.

Title. Concise, informative and reflects the study content. Titles are often used in information-retrieval systems. Avoid abbreviations and formulae where possible.

Running Title: A shorter running title of no more than 55 letters including spaces should be provided.

Author names and affiliations. Where the family name may be ambiguous (e.g., a double name), please indicate this clearly. Present the authors' affiliation addresses (where the actual work was done) below the names. Indicate all affiliations with a superscript Arabic number immediately after the author's name and in front of the appropriate address. Provide the full postal address of each affiliation, including the country name and the e-mail address and phone number (with country and area code) of each author.

Corresponding author. The corresponding author should be indicated in addition with a superscript asterisk * immediately after his/her affiliation superscript Arabic number. The corresponding author will handle correspondence at all stages of refereeing, publication, and post-publication. Contact details must be kept up to date by the corresponding author.

Present/permanent address. If an author has moved since the work described in the article was done, or was visiting at the time, a 'Present address' (or 'Permanent address') may be indicated as a footnote to that author's name. The address at which the author actually did the work must be retained as the main, affiliation address. Superscript lower-case letters are used for such footnotes.

Abstract

Page 2 of the typescript should be reserved for the abstract which should be presented in a structured format and should not exceed 350 words. The following headings should be included for research articles followed by a colon: a) Background, b) Hypothesis/Objectives: c) Materials/Patients and Methods: d) Results: e) Conclusions (should be data justified). Suitable headings could be used for other types of publications (Case reports, Review articles, etc.).

A concise and factual abstract is required. The abstract should state briefly the purpose of the research, the principal results and major conclusions. An abstract is often presented separately from the article, so it must be able to stand alone. For this reason, References should be avoided. Non-standard or uncommon abbreviations should be avoided, but if essential they must be defined at their first mention in the abstract itself.

Keywords

Immediately after the abstract, provide a maximum of 10 keywords for full papers, or 5 keywords for Short Communications, using American spelling and avoiding general and plural terms and multiple concepts (avoid, for example, "and", "of"). Please use terms from the most current issue of medical subject headings of Index Medicus. The key words should cover precisely the contents of the submitted paper and should give readers sufficient information as to the relevance of the paper to his/her particular field. Be sparing with abbreviations: only abbreviations firmly established in the field may be eligible. These keywords will be used for indexing purposes.

Introduction

Provide adequate background that highlights the importance and gap information of your research point in relation to previous studies but avoiding a detailed literature survey. State the hypothesis or rationale and objectives of the work and a brief description of how you planned to approach them.

Materials or Patients and Methods

Provide sufficient detail to allow the work to be reproduced, with details of supplier and catalogue number when appropriate. Methods already published should be indicated by a reference: only relevant modifications should be described.

Patients and Normal Subjects

If human participants were used in the experiment please make a statement to the effect that this study has been approved by your Institution Ethics Review Board for human studies (the number of the approval should be stated in the methods section and JUMJ may ask for submission of the original ethical approval with the manuscript), and, that patients or their custodians have signed an informed consent that also states right of withdrawal without any consequences. Sample sized should be appropriately calculated. The manuscript should describe how the size of the experiment was planned. If a sample size calculation was performed this should be reported in detail, including the expected



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difference between groups, the expected variance, the planned analysis method, the desired statistical power and the sample size thus calculated. For parametric data, variance should be reported as 95% confidence limits or standard deviations rather than as the standard error of the mean. Normal participants and patients criteria, inclusion and exclusion criteria should be stated. Name and address where the work was done and when it was done (time period, from …. to …..) should be clearly stated, too.

Experimental animals

When animals were used in the experiments, a local Institutional Ethics Review Board for animal studies should review and approve the experiment and that all animal procedures were in accordance with the standards set forth in guidelines for the care and use of experimental animals by Committee for Purpose of Supervision of Experiments on Animals (CPCSEA) and according to National Institute of Health (NIH) protocol. The precise species, strain, sub-strain and source of animals used should be stated. Where applicable (for instance in studies with genetically modified animals) the generation should also be given, as well as the details of the wild-type control group (for instance littermate, back cross etc.). The manuscript should describe the method by which animals were allocated (randomized) to experimental groups, particularly for comparisons between groups of genetically modified animals (transgenic, knockout etc.), the method of allocation to for instance sham operation or focal ischemia should be described.

Experimental

Provide sufficient detail to allow the work to be reproduced. Methods already published should be indicated by a reference: only relevant modifications should be described. Where and when the study was conducted should be stated.

Results

Results should be clear and concise. Data should be presented in an appropriately organized tables, figures and/or artworks. The statistical analysis used should be suitable for the objectives of the study and type of data analyzed. Prospective authors are highly advised to consult a biostatician.

Footnotes

Footnotes should be used sparingly. For table footnotes, indicate each footnote in a table with a superscript lowercase letter or add them into the title.

Graphical abstract

A Graphical abstract is optional and should summarize the contents of the article in a concise, pictorial form designed to capture the attention of a wide readership online. Authors must provide images that clearly represent the work described in the article. Please provide an image with a minimum of 531 × 1328 pixels (h × w) or proportionally more. The image should be readable at a size of 5 × 13 cm using a regular screen resolution of 96 dpi. It is preferable to be inserted at its normal place to the relevant text or otherwise be submitted as a separate TIFF, EPS, PDF or MS Office files.

Discussion

This should explore the significance, interpretation and reasoning of the results of the work vs. other studies. Do not repeat describing the results in this section. A combined Results and Discussion section is acceptable. Avoid extensive citations and discussion of published literature. In the same time, avoid speculations without a supporting literature. Avoid discussion based on "Data not Shown" or "Personal Communications".

Limitations and Future Prospective

The authors may wish to pinpoint the limitations of the study and their reason and foresee the next step to go from their study. This may be presented in a short Limitations and Future Prospective section standing alone or as a separate paragraph in the Discussion or Results/Discussion section.

Conclusions

The main conclusions of the study may be presented in a short Conclusions section standing alone or as a separate paragraph at the end of the Discussion or Results/Discussion section. Conclusions should not be biased and should be based on the data, presented and discussed inside the manuscript only.

Gain of Knowledge

Following the conclusion section, it is mandatory for manuscripts submitted for final publication in JUMJ to have a Gain of Knowledge section that is consisted of 2 - 5 bullet points (maximum 90 characters, including spaces, per bullet point) that convey the core findings of the article.

Acknowledgements and Funding

Collate acknowledgements in a separate section at the end of the article before the references. List individuals or organizations that provided help during the research (e.g., providing language help, writing assistance or proof reading the article, etc.). Whoever would



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be acknowledged should be informed and a verification for that could be requested by JUMJ Editor. If funded, the source of funding should be mentioned.

Appendices

If there is more than one appendix, they should be identified as A, B, etc. Formulae and equations in appendices should be given separate numbering: Eq. (A.1), Eq. (A.2), etc.; in a subsequent appendix, Eq. (B.1) and so on. Similarly, for tables and figures: Table A.1; Fig. A.1, etc.

CASE REPORT WRITING TEMPLATE

Title. Include the words “case report” in the title. Describe the phenomenon of greatest interest (e.g., symptom, diagnosis, diagnostic test, intervention, and outcome).

Abstract. Summarize the following information if relevant: 1) Rationale for this case report, 2) Presenting concerns (e.g., chief complaints or symptoms, diagnoses), 3) Interventions (e.g., diagnostic, preventive, prognostic, therapeutic exchange), 4) Outcomes, and 5) Main lesson(s) from this case report.

Key Words. Provide 3 - 8 key words that will help potential readers search for and find this case report.

Introduction. Briefly summarize the background and context of this case report.

Presenting Concerns. Describe the patient characteristics (e.g., relevant demographics - age, gender, ethnicity, occupation) and their presenting concern(s) with relevant details of related past interventions.

Clinical Findings. Describe: 1) the medical, family, and psychosocial history including lifestyle and genetic information; 2) pertinent co-morbidities and relevant interventions (e.g., self-care, other therapies); and 3) the physical examination (PE) focused on the pertinent findings including results from testing.

Timeline. Create a timeline that includes specific dates and times (table, figure, or graphic).

Diagnostic Focus and Assessment. Provide an assessment of the; 1) diagnostic methods (e.g., PE, laboratory testing, imaging, questionnaires, referral), 2) diagnostic challenges (e.g., financial, patient availability, cultural), 3) diagnostic reasoning including other diagnoses considered, and, 4) prognostic characteristics (e.g., staging) where applicable.

Therapeutic Focus and Assessment. Describe: 1) the type(s) of intervention (e.g., preventive, pharmacologic, surgical, lifestyle, self-care) and 2) the administration and intensity of the

intervention (e.g., dosage, strength, duration, frequency.

Follow-up and Outcomes. Describe the clinical course of this case including all follow-up visits as well as 1) intervention modification, interruption, or discontinuation, and the reasons; 2) adherence to the intervention and how this was assessed; and 3) adverse effects or unanticipated events. In addition, describe: 1) patient-reported outcomes, 2) clinician-assessed and ‐reported outcomes, and 3) important positive and negative test results.

Discussion. Please describe: 1) the strengths and limitations of this case report including case management, 2) the literature relevant to this case report (the scientific and clinical context), 3) the rationale for your conclusions (e.g., potential causal links and generalizability), and 4) the main findings of this case report: What are the take-away messages?

Patient Perspective. The patient should share his or her experience or perspective of the care in a narrative that accompanies the case report whenever appropriate.

Informed Consent. Did the patient or their custodian give the author of this case report informed consent? Provide if requested .

Case Report Submission Requirements: 1) Competing interests, are there any competing interests? 2) Ethics Approval, Did an ethics committee or institutional review board review give approval? If yes, please provide if requested, 3) De‐Identification, has all patient's related data been de-identified?

RANDOMIZED CLINICAL TRIALS WRITING TEMPLATE

In this particular type of original study, individuals are randomly allocated to receive or not receive a preventive, therapeutic, or diagnostic intervention and then followed up to determine the effect of the intervention. All randomized clinical trials should include a flow diagram and authors should provide a completed randomized trial checklist (see CONSORT Flow Diagram and Checklist; http://www.consort-statement.org) and a trial protocol.

Authors of randomized controlled trials are encouraged to submit trial protocols along with their manuscripts.

All clinical trials must be registered (before recruitment of the first participant) at an appropriate online public that must be independent of for-profit interest, e.g.:

http://www.clinicaltrials.gov; http://www.anzctr.org.au;

http://www.clinicaltrials.gov/

http://www.anzctr.org.au/



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http://www.umin.ac.jp/ctr; http://isrctn.org; http://www.trialregister.nl/trialreg/index.as

p).

Each manuscript should clearly state an objective or hypothesis; the design and methods (including the study setting and dates, patients or participants with inclusion and exclusion criteria, or data sources, and how these were selected for the study); the essential features of any interventions; the main outcome measures; the main results of the study; a comment section placing the results in context with the published literature and addressing study limitations; and the conclusions.

Data included in research reports must be original. A structured abstract not exceeding 300 words is required. Clinical trials are limited to 2700 words (not including abstract, tables, figures, and references), 40 references, and no more than 5 tables and figures.

REVIEW, MINIREVIEW AND META-ANALYSIS PAPERS

These papers will not have empirical data acquired by the authors but will include historical perspectives, analysis and discussion of papers published and data acquired in a specific area.

Systematic reviews and meta-analyses are a particular type of original articles that perform systematic, critical assessment of literature and data sources pertaining to clinical topics, emphasizing factors such as cause, diagnosis, prognosis, therapy, or prevention. All articles or data sources should be searched for and selected systematically for inclusion and critically evaluated, and the search and selection process should be described in detail in the manuscript. The specific type of study or analysis, population, intervention, exposure, and tests or outcomes should be described for each article or data source. A structured abstract of less than 300 words is required. The text is limited to 3500 words (not including abstract, tables, figures, and references); about 4 tables (a flow diagram that depicts search and selection processes as well as evidence tables should be included) - and no reference limit.

Minireview is a brief historical perspective, or summaries of developments in fast-moving areas covered within the scope of the journal. They must be based on published articles; they are not outlets for unpublished data. They may address any subject within the scope of the journal. The goal of the minireview is to provide a concise very up-to-date summary of

a particular field in a manner understandable to all readers.

SHORT COMMUNICATION AND SHORT RESEARCH ARTICLE

Short Communications are urgent communications of important preliminary results that are very original, of high interest and likely to have a significant impact on the subject area of the journal. A Short Communication needs only to demonstrate a „proof of principle‟. Authors are encouraged to submit an Original Research Paper to the journal following their Short Communication. There is no strict page limit for a Short Communication; however, a length of 2500-3500 words, plus 2-3 figures and/or tables, and 15-20 key references is advisable. Short Research Article may be smaller single-result findings as a brief summary that include enough information, particularly in the methods and results sections, that a reader could understand what was done.

POLICY PAPER

The purpose of the policy paper is to provide a comprehensive and persuasive argument justifying the policy recommendations presented in the paper, and therefore to act as a decision-making tool and a call to action for the target audience.

COMMENTARIES/OPINION ARTICLES

An opinion-based article on a topical issue of broad interest, which is intended to engender discussion.

STUDY PROTOCOLS AND PRE-PROTOCOLS

JUMJ welcomes publishing protocols for any study design, including observational studies and systematic reviews. All protocols for randomized clinical trials must be registered and follow the CONSORT guidelines; ethical approval for the study must have been already granted. Study pre-protocols (i.e., discussing provisional study designs) may also be submitted and will be clearly labeled as such when published. Study protocols for pilot and feasibility studies may also be considered.

METHOD ARTICLES

These articles describe a new experimental or computational method, test or procedure, and should have been well tested. This includes new study methods, substantive modifications to existing methods or innovative applications of existing methods to new models or scientific questions. We also welcome new technical tools that facilitate the design or performance of experiments or operations and

http://www.umin.ac.jp/ctr

http://isrctn.org/

http://www.trialregister.nl/trialreg/index.asp

http://www.trialregister.nl/trialreg/index.asp



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data analysis such as software and laboratory and surgical devices, or of new technologies to assist medical diagnosis and treatment such as drug delivery devices.

Maximum length of submissions

Full length original research articles should not exceed 10000 words (maximum 60 references), and up to 6 tables and/or figures.

Short communications comprising up to 1800 words of text, maximum 15 references, and two illustrative items (Tables and/or Figures).

Letters and Case Reports (provide novel insight into disease mechanisms, diagnostic and management applications). Clinical Laboratory Notes (technical evaluation or important insight into analytical methodology), or Letters to the Editor (focused on a specific article that has appeared in JUMJ within 4 weeks of print issue date of article). For all 3 types of letters listed above, the text should not exceed 600 words, with no abstract, a maximum of 1 table or figure and up to 5 references.

Review Articles, Surveys, Essays, and Special Reports may exceed the word and reference limit for Full-length articles as per the comprehensive nature of these articles. However, both of these articles (Reviews and Special Reports) will still require an abstract (unstructured, 350 word maximum).

Editorials, Meeting summary, Commentaries, Book review and Opinion pieces will not require an abstract and will be limited to 2000 words and up to 20 references. A book review is a brief critical and unbiased evaluation of a current book determined to be of interest to the journal audience. Publication of a submitted book review is at the discretion of the editor.

Artwork

General points

Make sure you use uniform lettering and sizing of your original artwork. Preferred fonts: Arial (or Helvetica), Times New Roman (or Times), Symbol, Courier. Number the illustrations according to their sequence in the text. Use a logical naming convention for your artwork files. Indicate per figure if it is a single, 1.5 or 2-column fitting image. For Word submissions only, you may still provide figures and their captions, and tables within a single file at the revision stage.

Formats

Regardless of the application used, when your electronic artwork is finalized, please 'save as' or convert the images to one of the following formats (note the resolution requirements for line drawings, halftones, and line/halftone

combinations given below). Please do not supply files that are optimized for screen use (e.g., GIF, BMP, PICT, WPG); the resolution is too low, supply files that are too low in resolution, and, submit graphics that are disproportionately large for the content.

EPS (or PDF): Vector drawings. Embed the font or save the text as 'graphics'.

TIFF (or JPG): Color or grayscale photographs (halftones): always use a minimum of 300 dpi.

TIFF (or JPG): Bitmapped line drawings: use a minimum of 1000 dpi.

TIFF (or JPG): Combinations bitmapped line/half-tone (color or grayscale): a minimum of 500 dpi is required.

Color artwork

Please make sure that artwork files are in an acceptable format (TIFF (or JPEG), EPS (or PDF), or MS Office files) and with the correct resolution. If, together with your accepted article, you submit usable color figures the Journal will ensure that these figures will appear in color on the Web regardless of whether or not these illustrations are reproduced in color in the printed version. Because of technical complications which can arise by converting color figures to 'gray scale' please submit in addition usable black and white versions of all the color illustrations.

Figure captions

Ensure that each illustration has a caption (Legend). A caption should comprise a brief title below the figure that describes its content and not to be general. Keep text in the illustrations themselves to a minimum but explain all symbols and abbreviations used in the legend. Figure caption should stand for itself (self-explanatory) without the need for consulting the text.

Tables

Number tables consecutively in accordance with their appearance in the text. Place footnotes to tables below the table body and indicate them with superscript lowercase letters within the table. If necessary, such footnotes could be placed at the end of the table title. Avoid vertical rules. Be sparing in the use of tables and ensure that the data presented in tables do not duplicate results described elsewhere in the article (Figures or text). The table caption (Title) should be brief but describes its content and not to be general. Explain all symbols and abbreviations used in the table in the footnote. Table title should stand for itself (self-explanatory) without the need for consulting the text. The table structure should be scientifically organized



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(columns and rows) and its message should be easily comprehendible.

The Editor-in-Chief, on accepting a manuscript, may recommend that additional tables and/or graphs containing important backup data, too extensive to be published in the article, may be published as supplementary material. In that event, an appropriate statement will be added to the text. However, the author should submit such material for consideration with the manuscript.

References

References cited should be relevant, up-to-date and adequately cover the field without ignoring any supportive or conflicting publications. Please ensure that every reference cited in the text is also present in the reference list (and vice versa). If present, unpublished results and personal communications may be mentioned in the text and not in the reference list. Citation of a reference as 'in press' implies that the item has been accepted for publication and shows up on PubMed literature search or a copy of the title page of the relevant article must be submitted. DOI of the references - whenever applicable should be presented. Authors are encouraged to cite primary literature rather than review articles in order to give credit to those who have done the original work.

Reference management software

This journal has standard templates available in key reference management packages EndNote (http://www.endnote.com/support/enstyles.asp) and Reference Manager (http://refman.com/support/rmstyles.asp). Using plug-ins to word processing packages, authors only need to select the appropriate journal template when preparing their article and the list of references and citations to these will be formatted according to the journal style, which is described below.

Reference formatting

There are no strict requirements on reference formatting at submission but should be consistent, complete and up-to-date. Where applicable, author(s) name(s), chapter title/article title, journal title/book title, year of publication, volume number-issue number/book chapter and the pagination must be present. For the book reference, the edition number, editors (if they are not the authors), publisher and its main address (City and Country) should be added as described below in the example. The reference style used by the journal should be applied to the accepted article at the proof stage. Note that missing

data will be highlighted at proof stage for the author to correct. Use peer-reviewed references only except for national and international organizational reporting and registers. If you do wish to format the references yourself, they should be arranged according to the following examples:

Reference style

Indicate references by number(s) in curved brackets as a bolded superscript at the end of the cited text(s) before the full stop, e.g., ………. shorter hospital stay and lower cost(20). The actual authors can be referred to, but the reference number(s) must always be given. Number the references in the list in the order in which they appear in the text. The authors list should not be shortened, all authors‟ names should be mentioned up to 10 authors and end longer list by et al. For further details you are referred to 'Uniform Requirements for Manuscripts submitted to Biomedical Journals' (J Am Med Assoc 1997; 277: 927-34) (see also http://www.nlm.nih.gov/bsd/uniform_requirements.html).

Examples:

Reference to a journal publication: Format your journal publications according to the following examples depending on whether; 1) It is already published with specific page numbers, 2 and 3) It is already published with article ID number and pages from 1 to …, 4) It is published put ahead of print, or, it is accepted for publication.

1. Van der Geer J, Hanraads JAJ, Lupton RA. The art of writing a scientific article. J. Sci. Commun., 2010;163(1):51-9.

2. Leta S, Dao TH, Mesele F, Alemayehu G. Visceral Leishmaniasis in Ethiopia: An Evolving Disease. PLoS Negl Trop Dis., 2014; 8(9):e3131;1-7.

3. Arjmand MH, Ahmad Shah F, Saleh Moghadam M, Tara F, Jalili A, Mosavi Bazaz M, Hamidi Alamdari D. Prooxidant-antioxidant balance in umbilical cord blood of infants with meconium stained of amniotic fluid. Biochem Res Int., 2013;2013:ID270545;1-4.

4. Teferra RA, Grant BJ, Mindel JW, Siddiqi TA, Iftikhar IH, Ajaz F, Aliling JP, Khan MS, Hoffmann SP, Magalang UJ. Cost minimization using an artificial neural network sleep apnea prediction tool for sleep studies. Ann Am Thorac Soc., 2018 Jul 28 (ahead of print).

5. Alduraywish AA, Almani AZ, Alanazi AD-A, Alruwaili FS, Alolaywi AN, Almaeen AH, El-Metwally TH. Vitamin D insufficiency among healthy participants

http://www.nlm.nih.gov/bsd/uniform_requirements.html

http://www.nlm.nih.gov/bsd/uniform_requirements.html



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and type 2 diabetic patients from the northern Al-Jouf region of Saudi Arabia: Correlation with the prognostic indices of the disease. International Medical J, 2019 (Accepted for publication; http://www.seronjihou.co.jp/imj/).

Reference to a book: Strunk Jr W, White EB (Editors). The elements of style, 4th Edition, Longman, New York; 2000, pp. 210-9.

Reference to a chapter in an edited book: Mettam GR, Adams LB. How to prepare an electronic version of your article. In: Jones BS, Smith RZ (Editors), Introduction to the electronic age, 1st Edition, E-Publishing Inc., New York, 2009, Chapter 2: pp. 281-304.

Reference to a homepage: It is acceptable to refer to an Organizational Guidelines, Reports, Forms, Data sheets, Questionnaires, etc. It should follow the following format. World Health Organization. Non-communicable Diseases (NCD) Country Profile, 2014 (http://www.who.int/globalcoordinationmechanism/publications/ncds-country-profiles-eng.pdf; last accessed March 1, 2017).

Journal abbreviations source

Journal names should be abbreviated according to the List of Title Word Abbreviations: http://www.issn.org/services/online-services/access-to-the-ltwa/.

Abbreviations and units

Standard abbreviations as listed in the Council of Biology Editors Style Manual may be used without definition. Use non-standard abbreviations sparingly, preceding their first use in the text with the corresponding full designation. Use units in conformity with the standard International System (SI) of units.

Video data

The journal accepts video material and animation sequences to support and enhance your scientific research. Authors who have video or animation files that they wish to submit with their article are strongly encouraged to include links to these within the body of the article. This can be done in the same way as a figure or table by referring to the video or animation content and noting in the body text where it should be placed. All submitted files should be properly labeled so that they directly relate to the video file's content. To ensure that your video or animation material is directly usable, please provide the files in one of our recommended file formats with a preferred maximum size of 50 MB. Video and animation files supplied will be published online in the electronic version of your article. Since video and

animation cannot be embedded in the print version of the journal, please provide text for both the electronic and the print version for the portions of the article that refer to this content.

Audio Slides

JUMJ encourages authors to create an Audio Slides presentation with their published article as supplementary material. This gives authors the opportunity to summarize their research in their own words and to help readers understand what the paper is about. Authors of this journal will automatically receive an invitation e-mail to create an Audio Slides presentation after acceptance of their paper.

Supplementary data

JUMJ accepts electronic supplementary material to support and enhance your scientific research. Supplementary files offer the author additional possibilities to publish supporting applications, high-resolution images, background datasets, sound clips and more. Supplementary files supplied will be published online alongside the electronic version of your article. In order to ensure that your submitted material is directly usable, please provide the data in one of our recommended file formats. Authors should submit the material in electronic format together with the article and supply a concise and descriptive caption for each file.

Supplementary material captions

Each supplementary material file should have a short caption which will be placed at the bottom of the article, where it can assist the reader and also be used by search engines.

THE COPYRIGHTS

The copyrights of all papers published in this journal are retained by the respective authors as per the 'Creative Commons Attribution License' (http://creativecommons.org/licenses/by/3.0/). The author(s) should be the sole author(s) of the article and should have full authority to enter into agreement and in granting rights to the journal, which are not in breach of any other obligation. The author(s) should ensure the integrity of the paper and related works. Authors should mandatorily ensure that submission of manuscript to JUMJ would result into no breach of contract or of confidence or of commitment given to secrecy.

Submission checklist

The following list will be useful during the final checking of an article prior to sending it to the journal for review. Please consult this Guide for Authors for further details of any item.



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To avoid unnecessary errors, you are strongly advised to use the 'spell-check' and 'grammar-check' functions of your word processor.

Ensure that the following items are present:

One author has been designated as the corresponding author with contact details for all authors:

E-mail address. Full postal address. Telephone.

All necessary files have been uploaded, and contain:

Keywords. All figures and their captions. All tables (including title, description,

footnotes).

Further considerations:

Manuscript has been 'spell-checked' and 'grammar-checked'.

All references mentioned in the Reference list are cited in the text, and vice versa.

Permission has been obtained for use of copyrighted material from other sources (including the Web).

Color figures are clearly marked as being intended for color reproduction on and in print, or to be reproduced in color electronically and in black-and-white in print.

PEER REVIEW PROCESS

High quality manuscripts are peer-reviewed by minimum of two peers of the same field along with a biostatistician in the case the study requires. Pre-reviewing advice and help will be provided by the Editor-In-Chief on first submission for initial improvements to meeting the minimum criteria of peer-reviewing. The journal follows strict double-blind fold constructive review policy to ensure neutral evaluation. During this review process identity of both the authors and reviewers are kept hidden to ensure unbiased evaluation. A cycle of one-month reviewing process is the target of the journal from submission to final acceptance. For meeting this goal, the Editor-In-Chief is expecting strict compliance from author hastening corrections and replying editorial requests. Continuous post-publication open peer reviewing is highly encouraged through submitting comments to the Editor on any of the published article that will show up with author reply in the subsequent issue to the journal.

The reviewers‟ comments are sent to authors once received. With the help of the reviewers‟ comments, FINAL decision (accepted or accepted with minor revision or accepted with

major revision or rejected) will be sent to the corresponding author. Reviewers are asked if they would like to review a revised version of the manuscript. The editorial office may request a re-review regardless of a reviewer's response in order to ensure a thorough and fair evaluation.

In order to maintain this journal‟s mission of one-month publication cycle, authors are encouraged to submit the revised manuscript within one week of receipt of reviewer‟s comment (in case of minor corrections). However, revised manuscript submission should not go beyond 2 weeks (only for the cases of major revision which involves additional experiment, analysis etc.). Along with corrected manuscript authors will be requested to submit filled a point-by-point answers to the reviewers' comments and any rebuttal to any point raised. The Editor-In-Chief of the journal will have exclusive power to take final decision for acceptance or rejection during any dispute.

Under special circumstance, if the review process takes more time, author(s) will be informed accordingly. The editorial board or referees may re-review manuscripts that are accepted pending revision. Manuscripts with latest and significant findings will be handled with the highest priority so that it could be published within a very short time. The journal is determined to promote integrity in research publication. In case of any suspected misconduct, the journal management reserves the right to re-review any manuscript at any stages before final publication.

Our massage to JUMJ potential reviewers says “Although the Manuscript General Evaluation Form is attached, we like to instigate a policy of constructive reviewing and to do our best to make the submitted manuscripts publishable - provided that it is genuine and contain no major frauds of republication, duplicate use of self-data or plagiarism of intellectual properties of the others. Please, make your changes and insert your corrections, comments and suggestions directly into the manuscript text but in a different color. Please also make sure that the author(s) presented an inclusive and updated list of genuine references, applied proper statistics and extracted justified conclusions”.

Manuscript General Revision Form

The Manuscript Assigned Number and Title: ……..

Although the following manuscript general evaluation form is sent to reviewers, JUMJ asks the reviewer for further meticulous one-



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word-at-a-time revision, please. Please insert corrections, changes, suggestions, questions, comments and points of deficiency directly into the manuscript text but in a different color. Also, please do not worry much for the formatting.

The Manuscript Evaluation Score: Please, score the manuscript from 0 to 4 (highest) for each of the following items, and sum the total score. Please, also check if the statistics of the results require revision.

Items Scores 0 1 2 3 4 Item Score

The Study is a Priority Problem

Originality

Significance of the Work

Research Design

Quality and Clarity of the English Writing

Standard and Reproducible Methodology

Results Presentation and Appropriate Statistics

Relevant Discussion and Justified Conclusions

Tables/ Illustrations/ Figures

References: Inclusive and Updated

Total score

Requires Statistical Revision (Mark Please)

Yes No

Justification for Decision & Feedback for the Author (REQUIRED): JUMJ recommends the reviewer to introduce such justifications and feedback into the text at the appropriate places within the manuscript (Specific and Comprehensive Revision).

Note to the Editor (WELCOMED): JUMJ welcomes reviewer writing a note to the Editor

including conflict of interest that will not be disclosed to the Author(s).

The Decision: Should JUMJ publish the manuscript? Please, check the appropriate box.

Yes, without any revision:

Accepted

Yes, with minor revision and alterations:

Accepted with revision

Yes, with major revision and alterations:

Re-Evaluation after substantial

revision

No, this manuscript should be denied publication:

Denied

AFTER ACCEPTANCE

Online proof correction

Corresponding authors will receive an e-mail with annotation for correction of MS format proofs and resend the corrected version. All instructions for proofing will be given in the e-mail we send to authors. We will do everything possible to get your article published quickly and accurately - please upload all of your corrections within 48 hours. It is important to ensure that all corrections are sent back to us in one communication. Please check carefully before replying, as inclusion of any subsequent corrections cannot be guaranteed. Proofreading is solely your responsibility.

Offprints

The corresponding author, at no cost, will be provided with a PDF file of the article via email (the PDF file is a watermarked version of the published article and includes a cover sheet with the journal cover image and a disclaimer outlining the terms and conditions of use). For an extra charge, paper offprints can be ordered at any time via the offprint order form, which is sent once the article is accepted for publication.

Policy Regarding Corrections & Retractions

JUMJ differentiates the post-publication amendments into: Comments, Addenda, Corrections, and Retractions (or Partial Retractions).

Comments and Replies: An interested reader may approach the Editorial Office in cases of questionable results or experimental design and methods of a published article. Upon request, the Editorial Office will ask the reader to formulate his/her argument in a one-page evidence-supported comment on the article. In



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case the comment is valid after revision, the Editorial Office will approach the authors of the article in question and invite them to prepare a Reply. Reply will be reviewed, and if accepted, will be compiled with the comment for publication in the current issue of JUMJ, with page numbers added - with a hyperlink to the Comments and Replies appearing on the original publication. If the reader‟s complaints are substantiated without a valid refute from the authors, the authors in collaboration with the Editorial Office may consequently publish a Correction or decide to retract the paper entirely.

Addenda: If crucial results were unintentionally omitted from the original publication, the original article can be amended through an Addendum reporting these previously omitted results. The Addendum will be published, with page numbers added, in the current issue of the journal. A hyperlink to the Addendum will also be added to the original publication.

Corrections: Any corrections to published articles have to be reasonable and valid, and, will be published after revision and approval by the Editorial Office. Publication will be in the current issue of the journal, with page numbers added, as a separate Correction notice. A hyperlink to the corrections will also be added to the original publication.

Retractions: Published article that will be proven to contain incorrect, misrepresented, carelessly prepared, intentionally falsified or plagiarized content should be retracted. It threatens the integrity of scientific records of the authors and their institutions. Once such note of possible scientific misconduct reaches the Editorial Office, the Office will investigate the claim with authors, Editorial Board members, the author's institution authorities or other parties (as appropriate). In case proven correct, the original article will be retracted and a Retraction will be published, with page numbers added, as a separate item in the current issue of the journal, so that after issue release, the Retraction can be picked up by indexing & abstracting services. Retraction replaces the original publication on the website. The original publication is amended with a “RETRACTED” watermark, but will stay available on the journal‟s website for future reference. Retracted articles should not be cited and used for further research, as they cannot be relied upon. After similar processing and revision, Partial Retractions might be published in cases where results are only partially wrong.

AUTHOR INQUIRIES

For inquiries relating to the submission and follow up of review and proof correction of an article, please email us.

ABSTRACTING and INDIXENG

It is in processing since membership in such Data Bases and organizations requires precedential publication of a few issues of the journal.

PATIENT CONSENT FORM

Date: ………………...

Place: ……………….

Title of the article

Name of the Author(s)

Patient‟s name:

I give my consent for this material to be published in Aljouf University Medical Journal and associated publications without limit on the duration of publication.

I understand that the material will be published in Aljouf University Medical Journal will be included in any reprints of the published article. I understand that my name will not be included in the published article, and that every effort will be made to keep my identity anonymous in the text and in any images. However, I understand that complete anonymity and control of all uses cannot be guaranteed.

Signed: ………………

Full name of the relative: ……..........

Relation: ……………….

Patient‟s Name and Contact Address

Corresponding Author‟s Name and Contact Address

Alternative:

I have been offered the opportunity to preview the material in the format it will eventually appear and I am satisfied with it.

Signed: …..…………..

Full Name of the Patient: ……..……….

Jouf University Medical Journal (JUMJ)

Manuscript Submission and Copyright Transfer Form Newly submitted manuscript should be accompanied with this form. The form must be fully and accurately completed and signed by all authors before final acceptance. Scan the form and send it as an email attachment to [email protected].

By signing this form, I/We accept and/or certify of the following information:

1. I/We reviewed and approved the version submitted as a valid work. 2. I/We acknowledged all related direct and indirect source of grant, financial and material

supports and got appropriate written permission for data used in the manuscript. 3. I/We certify that the manuscript had not been previously published or is currently under

consideration for publication elsewhere. 4. I/We attest that, upon Editor's request, I/We will provide the data/information on which the

manuscript is bases for examination by the Editor or his assignees. 5. I/We have participated sufficiently in the work to take public responsibility for all or part of

the content. My intellectual contribution was in the form of (please, put author number beside the suitable activity):

a. Concept and design. b. Acquisition of data. c. Analysis of data. d. Drafting the article. e. Critically revising the article.

6. I/We agree that the authors mentioned are my/our coauthors in the sequence presented and that the named corresponding author shall be the sole correspondent with the Editorial Office in all matters related to this submission including review and correction of the final proof after which no substantial changes will be allowed.

7. To the best of my knowledge, I/We have specified the nature of all potential conflicts of interest. For authors that have nothing to declare, they should state it explicitly.

8. I/We hereby transfer all copyright ownership (preprinting, reprinting, republishing and translating in whole or in part in any format) to the Journal, in event that such work is published by the Journal, and I/We authorize the corresponding author to make the changes as per request of the Journal as the guarantor for the manuscript and to execute the Journal Publishing Agreement on our behalf.

9. If I am named as the corresponding author, I additionally certify that: a. All individuals who meet the criteria for authorship are included as authors. b. The version submitted is the version that all authors have approved. c. Written permission has been received by all individuals named in Acknowledgment

section.

Manuscript Assigned Number & Title: …………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………….………………………………………

Author(s) List (in order; Please highlight the Corresponding Author): # Name: Signature: # Name: Signature:

1 6

2 7

3 8

4 9

5 10

Date: Attached another blank paper for signature if necessary.


Jouf University Medical Journal (JUMJ)

IN THE NAME OF ALLAH,...Prof. Dr. Tarek Hassan El-Metwally, Professor of Medical Biochemistry and...

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