Cellular Phone-Based Technologies for Monitoring Of Patients With Diabetes: a Systematic Review and Meta Analysis

Systematic Review And Meta-Analysis Class 3PhD João FonsecaIntrodução à Medicina II

Overview

IntroductionMotivationResearch questionAims

Methods and ParticipantsSystematic review and Meta-analysisQueryInclusion and Exclusion criteriaSampling methodsData collectionStudies’ quality

Statistical analysis and ResultsDiabetes and the chronic diseasesCharacteristics of the studiesSecondary variablesOutcomesMeta-analysis

DiscussionMain findingsLimitationsCritical comparison with other studiesConclusions

IntroductionMotivationResearch questionAims

Methods and ParticipantsSystematic review and Meta-analysisQueryInclusion and Exclusion criteriaSampling methodsData collectionStudies’ quality

Statistical analysis and ResultsDiabetes and the chronic diseasesCharacteristics of the studiesSecondary variablesOutcomesMeta-analysis

DiscussionMain findingsLimitationsCritical comparison with other studiesConclusions

Chronic diseases

60% of all deaths [1]

Slow progression

Mobile phone based

tecnhologies

Applied in management of diseases [3]

Increasing international interest[2]

[1]http://www.who.int/en/, available at 1-11-2007[2] Pinnock Hilary, Slack Roger, Pagliari Claudia, Price David, Sheikh Aziz. Understanding the potential role of mobile phone-based monitoring on asthma self-

management: qualitative study. Clinical and Experimental Allergy. May 2007. 37(5):794-802; Available at: www.pubmed.com 26-10-2007.[3] Ryan D, Cobern W, Wheeler J, Price D, Tarassenko L; Mobile Phone Technology in the Management of Asthma; Journal of Telemedicine and Telecare 2005; 11

Suppl 1:4Kollmann et al., 2007 [6]-6; Available at: www.pubmed.com 26-10-2007

Motivation

Patient with diabetes

Quick communication of symptoms [4]

Healthcare professional

Communication of adapted treatment

Fig. 1_ The role of CPT in the monitoring of patients with chronic diseases

[4] Morak J, Kollmann A, Schreier G; Feasibility and usability of a home monitoring concept based on mobile phones and near field communication (NFC) technology; Medinfo. 2007; 12 (Pt 1):112-6; Available at: www.pubmed.com 26-10-2007.

Diabetes

High mortality

High morbidity

Increasing prevalence in society [5]

Selection of one disease

Clear and structured article

Focused article

[5] Amosa F.; Mccarty D. J.; Zimmet P., The rising global burden of diabetes and its implications: estimates and projections to the year 2010 ;Diabetic medicine ; 1997, vol.14, pp S7-S84, SUP5

“Does cellular phone based tecnhologies monitoring

improve diabetes patients’ clinical outcomes?”

Research question

Aims

* To describe the proportion of published studies about CPT regarding major chronic diseases.

* To investigate if CPT improves patients’ medical state

Glycosylated haemoglobin

Fasting plasma glycemia

IntroductionMotivationResearch questionAims

Methods and ParticipantsSystematic review and Meta-analysisQueryInclusion and Exclusion criteriaSampling methodsData collectionStudies’ quality

Statistical analysis and ResultsDiabetes and the chronic diseasesCharacteristics of the studiesSecondary variablesOutcomesMeta-analysis

DiscussionMain findingsLimitationsCritical comparison with other studiesConclusions

Search Collect Summarize

Evidence collected from

articles

Systematic review and Meta-analysis

((monitoring) OR (telemonitoring))

AND

((cellular phone-based technologies) OR (mobile phone-based technologies) OR (cellular phone) OR (mobile phone))

AND

((chronic diseases) OR (chronic patients) OR (cancer) OR (nephrologic diseases) OR (kidney insufficiency) OR (asthma) OR (respiratory chronic

diseases) OR (COPD) OR (diabetes) OR (cardiovascular disease)).

Query

Inclusion criteria Exclusion criteria

* Articles published in the last 10 years

* Articles containing original data

* Cellular phone-based technologies (CPT)

* Articles about the application of CPT in

patients

* Articles regarding diabetes

* Articles regarding comparison studies

* Articles regarding the evolution of the

clinical state of the patient

* Articles in English, Spanish and French

* Use of cellular-phone for interviewing

patients about other issues unrelated

to disease monitoring

* Articles that describe technologies and

their development

Inclusion and Exclusion criteria

33 14

3

Sampling methods

Fig.2 – Distribution of articles repeated among databases

Read abstract of 160 (inclusion and exclusion criteria) 50 repeated

among databases

Requested by e-mail

6 with no full-text

3 repeated within databases

Read full-text of 21 (inclusion and exclusion criteria)

80 excluded

7 excluded

9 with no abstract

Systematic review

5 articles included

4 excluded (no control group or no postest values)

2 articles included

Meta-analysis

2 answered1 included

* year of publication

* country of origin

* type of study

* n intervention

* n controls

* age group

* Glycosylated haemoglobinControl/intervention

* Fasting plasma glycemiaControl/intervention

Children : 0-14Youth: 15-17Adults: 18-65Elderly: +65

Data collection

Table 1 - Quality Criteria used to evaluate the final articles included, adapted from “Extending the CONSORT Statement to Randomized Trials of Nonpharmacologic Treatment: Explanation and Elaboration ”

Studies’ quality

Study section Quality criteria

Introduction 1. Objectives and/or hypotheses of the study

Methods

Intervention 2. Precise details of the interventions intended for each group and how they were actually administered

Outcomes 3. Clearly defined primary and secondary outcome measures

Statistical methods 4. Statistical methods used to compare groups for primary outcome(s)

Recruitment 5. Duration of recruitment and follow-up

Baseline data 6. Not existence of different characteristics in each group

Numbers analyzed 7. Number of participants in each group included in each analysis

Outcomes and estimation

8. For each primary and secondary outcome, a summary of results for each group and the estimated effect size and its precision (e.g., 95% confidence interval)

DiscussionGeneralizability 9. Generalizability (external validity) of the trial findings according to the intervention,

comparators, patients, and care providers and centers involved in the trial

Overall evidence 10. General interpretation of the results in the context of current evidence

Table 2 – Articles classification according to quality criteria

Criteria

Studies

TotalKollmann et al., 2007 [6]

Kim et al.,2006 [7]

Kim et al., 2007 [8]

Benhamou et al., 2007 [9]

Vahatalo et al., 2004 [10]

Ladyzynski et al. 2001 [11]

1 1 1 1 1 1 1 6

2 1 1 1 1 1 1 6

3 1 0 1 1 1 1 5

4 1 1 1 1 1 1 6

5 1 1 1 1 1 1 6

6 1 1 1 1 0 1 5

7 1 1 1 1 1 1 6

8 1 1 1 1 0 1 5

9 0 1 0 0 0 0 1

10 1 1 1 1 1 1 6

Total 9 9 9 9 7 9

IntroductionMotivationResearch questionAims

Methods and ParticipantsSystematic review and Meta-analysisQueryInclusion and Exclusion criteriaSampling methodsData collectionStudies’ quality

Statistical analysis and ResultsDiabetes and the chronic diseasesCharacteristics of the studiesSecondary variablesOutcomesMeta-analysis

DiscussionMain findingsLimitationsCritical comparison with other studiesConclusions

Graphic 1 - Distribuition of chronic diseases among obtained articles. Total number of articles obtained regarding chronic diseases N= 81

Diabetes and chronic diseases

Table 3 - Included articles characteristics

Characteristics of the studies

Article Year of publication Country Type of study n intervention n control Age group

Ladyzynski et al., 2001 [11] 2001 Poland Quasi-experimental 15 Adults

Vahatalo et al., 2004 [10] 2004 Finland Quasi-experimental 102 101 Adults

Kim et al., 2006 [7] 2006 South

Korea Quasi-experimental 33 Adults

Kollmann et al., 2007 [6] 2007 Austria Clinical trial 10 Adults

Kim et al., 2007 [8] 2007 South

Korea Clinical trial 25 26 Adults

Benhamou et al., 2007 [9] 2007 France Randomized

crossover study30 (29

glycemia)30 (28

glycemia) Adults

Table 4 - Secondary variables

Secondary variables

Secondary Variables

Articles

Kollmann et al., 2007 [6]

Kim et al., 2006 [7]

Kim et al., 2007 [8]

Benhamou et al., 2007 [9]

Vahatalo et al., 2004 [10]

Ladyzynski et al., 2001 [11]

Glycemia above 150 mg/dl p>0,05

Glycemia in normal range (80-150 mg/dl)

p>0,05

Glycemia below 50 mg/dl p>0,05

Two hours post-meal glucose (mg/dl)

p<0,05

Mean blood glucose (mg/dl) P< 0.05

Physical Exercise (d/wk) p<0,05

Diabetic medication taking (d/wk)

p<0,05 p<0,05

Foot Care (d/wk) p<0,05

Diabetic diet (d/wk) p>0,05

DQoL p<0,05

Satisfaction with life p<0,05

Table 5 - Extracted variables

Outcomes

Articles

Glycosylated haemoglobin %

intervention

Glycosylated haemoglobin %

control

Fasting plasma glycemia (mg/dl)

intervention

Fasting plasma glycemia (mg/dl)

control Posttest Pretest Posttest Pretest Posttest Pretest Posttest Pretest

Vahatalo et al., 2004 [10]

7.7±1.3 7.9± 1.5

0.45±1.2 0.35 ± 1.0

Kollmann et al., 2007 [6] 7,5± 0,9 7,9± 1,1 141,2±

23,1141,8±

22,5

Kim et al., 2007 [8] 7,04± 1,39 8,09± 1,72 7,70±

0,907,59± 1,09

145,7± 39,7

151,1± 25,7

149,5± 39,3

142,2± 24,1

Kim et al., 2006 [7]

7,0± 1,1 8,1± 2,1 -1,1± 2,1

Benhamou et al., 2007 [9]

8.18 ± 0.59 8.31 ± 0.65 8.34 ±

0.678.22 ± 0.72 160 ± 20 166 ± 23 167 ± 21 162 ± 22

– 0.14 ± 0.53 0.12 ± 0.65 – 5 ± 17 4 ± 18

Ladyzynski et al., 2001 [11] 7,1 ± 1,1 8,0 ± 1,1

Fig. 3 - Glycosilated haemoglobin forest plot

Meta-analysis

Glycosilated haemoglobin

Fig.4 - Fasting plasma glycemia forest plot

Fasting plasma glycemia

IntroductionMotivationResearch questionAims

Methods and ParticipantsSystematic review and Meta-analysisQueryInclusion and Exclusion criteriaSampling methodsData collectionStudies’ quality

Statistical analysis and ResultsDiabetes and the chronic diseasesCharacteristics of the studiesSecondary variablesOutcomesMeta-analysis

DiscussionMain findingsLimitationsCritical comparison with other studiesConclusions

Ladyzynski et al., 2001 [11]

Vahatalo et al., 2004 [10]

Kim et al., 2006 [7]

Kollmann et al., 2007 [6]

Benhamou et al., 2007 [9]

Kim et al., 2007 [8]

Clinical State S NS NS S

Adherence S S (Diet NS)

QoL and Satisfaction with life S

Glycosilated haemoglobin (Posttest-Pretest int.) S NS

(increase) S S NS S

Glycosilated haemoglobin (Posttest int. vs control) NS (decrease)

Fasting plasma glycemia (Posttest- Pretest int.) NS NS NS

Fasting plasma glycemia (Posttest int. vs control) NS (decrease)

Quality 9 7 9 9 9 9

Main findings

Table 6 – Summary of obtained results

Ladyzynski et al., 2001 [11]

Vahatalo et al., 2004 [10]

Kim et al., 2006 [7]

Kollmann et al., 2007 [6]

Benhamou et al., 2007 [9]

Kim et al., 2007 [8]

Clinical State S NS NS S

Adherence S S (Diet NS)

QoL and Satisfaction with life S

Quality 9 7 9 9 9 9

Clinical State: Measured in different waysImpossible to compare

Adherence: Significant except for Diabetic dietAdherence seem to increase with the use of CPT

QoL and Satisfaction with life:SignificantThis variable seem to increase with the use of CPT

Table 7 – Summary of results obtained for secondary variables and studies quality classification

Ladyzynski et al., 2001 [11]

Vahatalo et al., 2004 [10]

Kim et al., 2006 [7]

Kollmann et al., 2007 [6]

Benhamou et al., 2007 [9]

Kim et al., 2007 [8]

Glycosilated haemoglobin (Posttest-Pretest int.) S NS

(increase) S S NS S

Glycosilated haemoglobin (Posttest int. vs control) NS (decrease)

Quality 9 7 9 9 9 9

Glycosilated haemoglobin:Increases in Vahatalo et al., 2004 [10] (Quality 7)Decreases significantly in 4 of the studiesMeta-analysis not significant, although decreasesMeasured in different waysIncluded studies are different

Table 8 – Summary of results obtained for glycosilated haemoglobin

Ladyzynski et al., 2001 [11]

Vahatalo et al., 2004 [10]

Kim et al., 2006 [7]

Kollmann et al., 2007 [6]

Benhamou et al., 2007 [9]

Kim et al., 2007 [8]

Fasting plasma glycemia (Posttest- Pretest int.) NS NS NS

Fasting plasma glycemia (Posttest int. vs control) NS (decrease)

Quality 9 7 9 9 9 9

Fasting plasma glycemia:Measured in 3 studiesDecreases not significantly in every studiesMeta-analysis not significant, although decreases

Table 9 – Summary of results obtained for fasting plasma glycemia

Fasting plasma glycemia:Measured in 3 studiesDecreases not significantly in every studiesMeta-analysis not significant, although decreases

Clinical State: Measured in different waysImpossible to compare

Adherence: Significant except for Diabetic dietAdherence seem to increase with the use of CPT

QoL and Satisfaction with life:SignificantThis variable seem to increase with the use of CPT

Glycosilated haemoglobin:Decreases significantly in 4 of the studiesMeta-analysis not significant, although decreases

Limitations and Critical comparison with other studies

Small number of studiesSensitivity of the query?Too restrictive exclusion criteria?Requested articles?Data bases explored?Small number of published articles (recent area of interest)?Published articles have low quality?

Quality of the studiesStudies of short durationNo control groupWays of measuringLow number of participants

Paré et al., 2007 [12] (Systematic review)Bigger number of studies

Criteria applied less restrictive (older articles)Different databases explored

ConclusionsGlycosilated haemoglobin and Fasting plasma glycemia decrease

No meta-analysis found

31% of all articles report to diabetes

No meta-analysis found

Increasing number of patients with chronic diseases

Increasing mortality

Increasing costs for the National Health System

There is no cure, only regular treatments

Systematic review pointing the same conclusions

Increase of the adherence, clinical state and quality of life even if slightly

Older populationChanges in the way of life

Inconclusive results because of the small number of studies

Other chronic diseases are even less studied

Necessity of more studies and with more quality

Conclusions

Susana Carrilho

Sara CoelhoFernando Sá

Diogo Miguel

Alexandra Azevedo Ana Pessoa

Ana Lisboa

Ana Luísa Graça Pedro Lopes

Ana Luísa Padilhó

Joana Carvalho

Maycoll Vieira

Pedro Souteiro

Class 3

[1]http://www.who.int/en/, available on 1-11-2007[2] Hilary Pinnock, Roger Slack, Claudia Pagliari, David Price, Aziz Sheikh; Understanding the potential role of mobile phone-based monitoring on asthma self-management: qualitative study; Clinical and Experimental Allergy. 2007 May; 20077(5):794-802; Available at: www.pubmed.com 26-10-2007.[3] Ryan D, Cobern W, Wheeler J, Price D, Tarassenko L; Mobile Phone Technology in the Management of Asthma; Journal of Telemedicine and Telecare 2005; 11 Suppl 1:4Kollmann et al., 2007 [6]-6; Available at: www.pubmed.com 26-10-2007[4] Morak J, Kollmann A, Schreier G; Feasibility and usability of a home monitoring concept based on mobile phones and near field communication (NFC) technology; Medinfo. 2007; 12 (Pt 1):112-6; Available at: www.pubmed.com 26-10-2007.[5] Amosa F.; Mccarty D. J.; Zimmet P., The rising global burden of diabetes and its implications: estimates and projections to the year 2010 ;Diabetic medicine ; 1997, vol.14, pp S7-S84, SUP5 [6] Kollmann A, Riedl M, Kastner P, Schreier G, Ludvik B. Feasibility of a mobile phone-based data service for functional insulin treatment of type 1 diabetes mellitus patients. J Med Internet Res. Dez 2007; 31;9(5):e36.[7] Kim HS. Impact of Web-based nurse's education on glycosylated haemoglobin in type 2 diabetic patients; J Clin Nurs; Jul 2007; 16(7):1361-6.[8] Kim HS; A randomized controlled trial of a nurse short-message service by cellular phone for people with diabetes ; Int J Nurs Stud; Jul 2007; 687-92.[9] Benhamou, P, Melki, V, Boizel R, et al. One-year efficacy and safety of Web-based follow-up using cellular phone in type 1 diabetic patients under insulin pump therapy: the PumpNet study. Diabetes & Metabolism. Jun 2007; 33(2): 220-226.[10] Vahatalo, M.A., Virtamo, H.E., Viikari, J.S., Ronnemaa, T.; Cellular phone transferred self blood glucose monitoring: Prerequisites for positive outcome; Practical Diabetes International; 2004; 21 (5); 192-194.[11] Ladyzynski P, Wojcicki J, Krzymien J, et al. Teletransmission system upporting intensive insulin treatment of out-clinic type 1 diabetic pregnant women: Technical assessment during 3 years’ application. The International Journal of Artificial Organs. 2001. 24(3).[12] Paré G., Jaana M., Sicotte C.; Systematic Review of Home Telemonitoring for Chronic Diseases: The Evidence Base; J Am Med Inform Assoc. May–Jun 2007; 14(3): 269–277.

References