Clinical Practice Guidelines for selected clinical topics in Islamic Republic of Iran Dr. Shahram...

Clinical Practice Guidelinesfor selected clinical topics in

Islamic Republic of Iran

Dr. Shahram Yazdani

“The truth is rarely pure and never simple”

Oscar Wilde, 1895

• A clinical guideline is a statement which assists in decision-making for specific clinical conditions, for specific provider which is based on available evidence or research.

Guideline Effectiveness

• Research has shown that clinical practice guidelines can be an effective means of changing the process of health care and improving health outcomes (Grimshaw & Russell 1993, EHCB 1994).

ASSESSING THE EVIDENCE

Dr. Shahram Yazdani

Evidence Dimensions

• Strength of evidence• Size of effect• Outcome Relevance

Strength of evidence

• Level: – The study design used, as an indicator of the

degree to which bias has been eliminated by design

• Quality: – The methods used by investigators to minimize

bias within a study design.

• Statistical precision: – The P-value or, alternatively the precision of the

estimate of the effect (as indicated by the confidence interval). It reflects the degree of certainty about the existence of a true effect.

Evidence Dimensions

• Strength of evidence– Level– Quality– Statistical Precision

• Size of effect• Outcome Relevance

Level of Evidence

• The study design used, as an indicator of the degree to which bias has been eliminated by design

Types of studies used for assessing clinical

interventions• Systematic review• Experimental studies

– Randomized controlled trial– Pseudo-randomized controlled trial– Clustered randomized trial

• Comparative studies– Concurrent control or cohort– Case-control– Historical control– Interrupted time series

• Other observational studies– Case series

The Level of Evidence Depends on the Question type

PhenomenonEtiologyDiagnosisPrognosisTreatment

Types of Clinical Question

RCT CohortCase-

controlCaseSeries

Cross-sectional

Qualitative

Systematic ReviewsMeta-analyses

Types of Research


RCT CohortCase-

controlCaseSeries

Cross-sectional

Qualitative



II III III IV

I

II II III

I

II III III

I I

IV IV

I

IIIII


RCT CohortCase-

controlCaseSeries

Cross-sectional

Qualitative



II III III IV

I

II II III

I

II III III

I

IV IV

I I

Evidence Dimensions



Quality of Evidence

• The methods used by investigators to minimize bias within a study design.

Quality criteria for:Randomized controlled

trials• Was the study double blinded?• Was allocation to treatment groups

concealed from those responsible for recruiting the subjects?

• Were all randomized participants included in the analysis?

Quality criteria for:Cohort studies

• How were subjects selected for the ‘new intervention’?• How were subjects selected for the comparison or

control group?• Does the study adequately control for demographic

characteristics, clinical features and other potential confounding variables in the design or analysis?

• Was the measurement of outcomes unbiased (i.e. blinded to treatment group and comparable across groups)?

• Was follow-up long enough for outcomes to occur?• Was follow-up complete and were there exclusions

from the analysis?

Quality criteria for:Case-control studies

• How were cases defined and selected?• How were controls defined and selected?• Does the study adequately control for

demographic characteristics and important potential confounders in the design or analysis?

• Was measurement of exposure to the factor of interest (eg the new intervention) adequate and kept blinded to case/control status?

• Were all selected subjects included in the analysis?

Quality criteria for:Systematic reviews

• Was an adequate search strategy used?• Were the inclusion criteria appropriate and

applied in an unbiased way?• Was a quality assessment of included studies

undertaken?• Were the characteristics and results of the

individual studies appropriately summarized?• Were the methods for pooling the data

appropriate?• Were sources of heterogeneity explored?

Evaluation criteria are coded according to the extent to which the criteria are fulfilled

Code

Criterion entirely fulfilled a

Criterion mostly fulfilled b1

Criterion mostly not fulfilled b2

Criterion not at all fulfilled c

Criterion not described adequately to classify as a, b1, b2 or c

?

Criterion not applicable n/a

Coding for evaluation criteria

Codes for overall assessment of quality of study checklists

Low risk of bias

A All or most evaluation criteria from the checklist are fulfilled. Where evaluation criteria are not fulfilled, the conclusions of the study or review are thought very unlikely to alter.

Low - moderaterisk of bias

B1 Some evaluation criteria from the checklist are fulfilled. Where evaluation criteria are not fulfilled or are not adequately described, the conclusions of the study or review are thought unlikely to alter.

Moderate - highrisk of bias

B2 Some evaluation criteria from the checklist are fulfilled. Where evaluation criteria are not fulfilled or are not adequately described, the conclusions of the study or review are thought likely to alter.

High risk of bias

C Few or no evaluation criteria fulfilled. Where evaluation criteria are not fulfilled or are not adequately described, the conclusions of the study or review are thought very likely to alter.

Evidence Dimensions



Statistical precision of the effect

• The magnitude of the P-value and the precision (or width of the confidence interval) of the estimate of the treatment effect

• The P-value obtained from a statistical test corresponds to the probability of claiming that there is treatment effect when in fact there is no real effect.

• Incorrect rejection of the null hypothesis is called a Type I error.

Statistical precision of the effect

Alendronate

Alfa-Calcidiol

Calcitonin 50-400

Calcitonin 200

Calcitriol

Calcium

Etidronate

Fluoride

HRT

Raloxifene 60-120

Raloxifene 60

Risedronate

0 0.2 0.4 0.6 0.8 1 1.2 1.4 1.6 1.8 2

Relative Risk

Relative Risk of Vertebral FractureApplied

Relative Risk of Vertebral Fracture

Alendronate

Alfa-Calcidiol

Calcitonin 50-400

Calcitonin 200

Calcitriol

Calcium

Etidronate

Fluoride

HRT

Raloxifene 60-120

Raloxifene 60

Risedronate

0 0.2 0.4 0.6 0.8 1 1.2 1.4 1.6 1.8 2

Relative Risk

Evidence Dimensions


Size of effect

• The distance of the study estimate from the ‘null’ value and the inclusion of only clinically important effects in the confidence interval.

Measures of treatment effect

• The choice of the measure of treatment effect depends on a number of things, the most important being the scale of measurement used.

• The effect of some outcomes will be measured on a continuous scale (eg blood pressure, serum cholesterol, quality of life), while others are on a dichotomous or binary scale (eg improved/not improved, dead/alive, cancer recurrence/no recurrence).

Continuous outcomes

• Difference between group means

• Standardized difference• Weighted difference in means• Standardized weighted mean

difference

Binary outcomes

• Risk Difference (RD)• Relative Risk or Risk Ratio (RR)• Odds Ratio (OR)• Hazard Ratio (HR)• Number Needed to Treat (NNT)

1 2 3 4 5 6 7 8 9 -5 -4 -2 -1 0

12

11

10

9

8

7

6

5

4

3

2

1

0

-1

-2

-3

-4

-5

Alendronate

Alfacalcidol

Calcium Alone

Ca & Vit D

Calcitonin

Calcitriol

Etidronate

Fluoride

HRT

Raloxifene

Risedronate

Changes in spine BMD relative to placebo.

% Change in treatment group

% C

hange in placebo

group

Hypothetical Importance LinesSize of Study

Statistical Significance and Clinical Importance

Diff

ere

nc

e ClinicallyImportant

NullHypothesis

A clinically important benefit for the full range of plausible estimates. The point estimate of effect is clinically important but the confidence interval includes clinically unimportant (but statistically significant) effects

The point estimate of effect is not clinically important but the confidence interval include clinically important effects

The effect is statistically significant but the confidence interval does not include any clinically important effects

Statistically Significant

Not Statistically Significant

Clinically Important

Not Clinically Important

Statistical Significance and Clinical Importance

Diff

ere

nc

e ClinicallyImportant

NullHypothesis

The point estimate of effect is clinically important but the effect is not statistically significant

The effect is neither statistically significant nor clinically important but the confidence interval include clinically important effects

The effect is neither statistically significant nor clinically important The point estimate shows a negative effect but the confidence interval include clinically important effects

The point estimate shows a negative effect A negative effect for the full range of confidence interval

Statistically Significant

Not Statistically Significant

Clinically Important

Not Clinically Important

Evidence Dimensions


Outcome Relevance

• The usefulness of the evidence in clinical practice, particularly the appropriateness of the outcome measures used.

Types of Outcomes

• Surrogate • Clinical• Patient relevant

Surrogate outcomes

• A laboratory measurement or a physical sign used as a substitute for a clinically meaningful endpoint that measures directly how a patient feels, functions or survives. Changes induced by a therapy on a surrogate endpoint should be expected to reflect changes in a clinically meaningful endpoint

Disease related outcomes

• Outcomes that tend to be defined on the basis of the disease being studied; for example, survival in cancer, occurrence of vertebral fractures in treatments for osteoporosis, ulcer healing, walking distance or microbiological ‘cure’ in the treatment of infections.

Patient relevant outcomes

• Outcomes that matter to the patient and their careers. They need to be outcomes that patients can experience and that they care about (eg quality of life, return to normal function). Patient relevant outcomes may also be clinical outcomes or surrogate outcomes that are good predictors (in a causal sense) of outcomes that matter to the patient and their careers.

When are surrogate outcomes useful?

It should be a physiological variable. It should exhibit an association with a clinical

or patient-relevant outcome of interest. There should be a biological and

pathophysiological basis for believing that the surrogate outcome is a causal determinant of the clinical outcome in the disease being studied and that it is in the chain of causal events believed to be between the intervention and desired clinical or patient-relevant outcome.

Surrogate Disease related

Patient-relevant

Cardiovascular

blood pressure stroke, myocardialinfarction, MI mortality

Survival, QoL, functional status

HIV/AIDS CD4 T lymphocytecounts

AIDs events,AIDS survival


Fracture bone mineraldensity

bone fracture Survival, QoL, functional status

Coronary heartdisease

blood cholesterollevels

myocardialinfarction, MI survival


Otitis media microbiological‘cure’

clinical cure Survival, QoL, functional status

Disease

Outcome

Classifying the relevance of the evidence1. Evidence of an effect on patient-relevant outcomes,

including quality of life and survival.2. Evidence of an effect on patient-relevant outcomes,

including only survival.3. Evidence of an effect on disease specific outcomes,

combining positive and negative outcomes4. Evidence of an effect on one disease specific

outcomes5. Evidence of an effect on a surrogate outcome that

has been shown to be predictive of patient-relevant outcomes for the same intervention.

6. Evidence of an effect on proven surrogate outcomes but for a different intervention.

7. Evidence of an effect on proven surrogate outcomes but for a different intervention and population.

8. Evidence confined to unproven surrogate outcomes.

APPLYING THE EVIDENCE

Dr. Shahram Yazdani

Study Sample with

(α,β,γ,δ,ε,ζ)Specifications

Other Populations With the same(α,β,γ,δ,ε,ζ)

Specifications

External ValidityExtrapolation

Transferability

•The extent to which a study’s results provide a correct basis for generalization beyond

the setting of the study and the particular people studied to the theoretical population

•The application of results to a wider population than that studied (i.e. beyond

theoretical population).

•The extent to which a study’s results provide a correct basis for generalization beyond

the study sample

•The biological, and epidemiological differences in the people and the variations in the

nature of the disease that may alter the treatment effect.

Generalizability

Regarding general recommendation of performing BMD in all people older than 65 years

Life Expectancy (2002 Statistics)

Iran Canada Japan

Male 66.5 77.2 81.7

Female 71.7 82.3 85.3

In 60-70 years age group 30% of women and 10% of men have osteoporosisIn the same age group half of population have osteopenia

Tehran Study

66.5 71.7

43.4% difference between lifetime and 10-year risk32.2% difference between lifetime and 10-year risk19.9% difference between lifetime and 10-year risk

Meaningful for a 60 year Canadian woman with life expectancy of 82.3 years Meaningful for a 60 year Iranian woman with life expectancy of 71.7 years

• Cost of Bone Densitometry in Iran is about 250,000 Rls equals to cost of Alendronate therapy of a woman for 4.15 years

Study Sample with



Specifications


TransferabilityImplementabilityIndividualiziblity

•The availability, accessibility and affordability of interventions, appropriately trained personnel, and required infrastructures and the sociocultural acceptability of the program

Generalizability

• The strength of the individual patient's preferences for outcomes.

whether, for the individual patient, the predicted absolute benefit has greater value

than the harm and cost of treatment. This will vary with the patient’s expected event

rate (PEER)

Bismuth Antibiotic 1 Antibiotic 2 Proton Pump Inhibitor ?ID Day Eff #P Rls

Bismuth 2 QID Metronidazole 250 mg QID Tetracycline 500 mg QID Omeprazole 20 mg BID 4 14 96% 22 73836

Bismuth 2 QID Metronidazole 250 mg QID Tetracycline 500 mg QID 4 14 90% 20 51240

Bismuth 2 QID Metronidazole 250 mg TID Amoxicillin 500 mg TID 4 14 82% 14 56490


Bismuth 2 QID Clarithromycin 500 mg TID Tetracycline 500 mg QID 4 14 92% 19 866040

Bismuth 2 QID Clarithromycin 500 mg TID Amoxicillin 500 mg TID 4 14 92% 14 872340

Bismuth 2 QID Clarithromycin 500 mg BID Omeprazole 20 mg BID 4 8 80% 12 346032

Clarithromycin 500 mg BID Metronidazole 500 mg BID Omeprazole 20 mg BID 2 10 91% 8 409140

Amoxicillin 1 gr TID Metronidazole 250 mg QID Omeprazole 20 mg BID 4 14 90% 12 59556

Amoxicillin 1 gr BID Clarithromycin 500 mg BID Omeprazole 20 mg BID 2 10 96% 8 421740

Amoxicillin 1 gr BID Metronidazole 500 mg BID Omeprazole 20 mg BID 2 14 81% 10 48636

Amoxicillin 500 mg TID Omeprazole 40 mg BID 3 14 67% 7 61572

Amoxicillin 500 mg QID Clarithromycin 500 mg TID 4 14 91% 7 840840

Clarithromycin 500 mg TID Omeprazole 40 mg daily 3 14 74% 5 841596
















Rls

#P

D

?ID

Ef769 Rls/%Eradication
















Rls

#P

D

?ID


دارو فروش نام عددي

ريالي فروش

CIMETIDINE 200 MG TAB 152,353,500 8,988,856,500

CIMETIDINE 200MG/2ML AMP 8,212,314 3,152,809,010

RANITIDINE 150 MG TAB 592,469,160 57,469,508,520

RANITIDINE 25MG/ML 2ML AMP 3,507,864 2,449,362,775

RANITIDINE 50MG/5ML AMP 25,617 571,899,525

FAMOTIDINE 20 MG TAB 29,816,770 1,431,204,960

FAMOTIDINE 40 MG TAB 65,675,870 5,582,448,950

OMEPRAZOLE 20 MG CAP 69,735,470 51,185,834,980

SUCRALFATE 500 MG TAB 12,935,400 620,899,200

SUCRALFATE 1 G TAB 66,750 2,728,740,000

ALUMINIUM MG S SUSP 10,284,169 24,682,005,600

ALUMINIUM MG S TAB 75,636,600 2,722,917,600

BISMUTH SUBCITRATE 120 MG TAB 28,016,920 8,405,076,000

ALUMINIUM MG SUSP 4,149,664 9,751,710,400

ALUMINIUM MG TAB 52,301,600 1,830,556,000

181,573,830,000

• In Iran there are approximately 150,000 new cases and about 1 million recurrences of peptic ulcer disease yearly

• 150,000 Course of Peptic Ulcer Therapy with Famotidine– 950,000,000 Rls

• 1,000,000 Courses of H. Pylori Eradication – 48,000,000,000 Rls

• Total Expenditure – 48,950,000,000

• Cost Saving for the first year– 72%

• Cost Saving for the next year (considering %81 eradication rate of protocol)– %94

Study Sample with



Specifications


TransferabilityImplementabilityIndividualiziblity

Generalizability

• The strength of the individual patient's preferences for outcomes.

whether, for the individual patient, the predicted absolute benefit has greater value

than the harm and cost of treatment. This will vary with the patient’s expected event

rate (PEER)

Guideline Development

Dr. Shahram Yazdani

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Synthesis of Current Best Evidence with

Unique Local Conditionsand Requirements And Target Group

Considerations

Characteristics Local CPG EBS


1 Validity Less More



2 Relevance More Less




3 Practicality More Less





4 User-friendlily More Less






•Level of Evidence and Grade of Recommendation Mentioned•Referral to Studies and Articles






•Local Data, Requirements and Specifications•Confinement to Pharmacopoeia List•Availability of Drugs•Local Cost of Alternative Options

•International Data, Requirements and Specifications






•Target Specific•Final Recommendations•“If then” format•To do and not to do lists•Dose Recommendations•Further Readings

•NNTs, Risk Reductions, Likelihood Ratios, P values•Physiopathology•Basic Science•Reference List






•Highly Tabulated•Highly Diagrammatic•Use of Flowcharts•Highly Colorful

• “Local Clinical Practice Guidelines” are always more Prescriptive than “Evidence Based Statements”

Selection of Guideline Topics

Composition of Guideline Development Group

Systematic Literature Review

Formation of Recommendations

Consultation and Peer Review

Presentation and Dissemination

Local Implementation

Audit and Review

• Select Topics of Concern• Design a General Framework• Select Team of Experts • Orientation Cessions for Team of Experts• Generate List of Questions for each Topic• Systematically Review the Literature• Consider Different Alternatives for each Question• Consider Strength of Evidence for Different Alternatives• Consider Size of Effect for Different Alternatives• Consider Outcome Relevance for Evidences on Different

Alternatives• Consider Availability, Accessibility, and Affordability and Local

Cost of Different Alternatives• Consider Unique Biologic, Epidemiologic and Socio-cultural

Characteristics when Applicable• Compile LCPG According to General Framework

The Process of Arriving at LCPGs

Topics for clinical guideline development

• Common (high volume) clinical problems• Variation in clinical practice • General clinical uncertainty or controversy • High cost and/or resourcing • High risk issues • The introduction of new diagnostic tests, therapeutic

procedures or medication • Quality of care issues perceived by patients, clinicians or

managers • Frequent complaints • Several disciplines are involved (eg doctors, nurses,

therapists)

Guideline Topics

1. Upper Respiratory Tract Infection

2. Hyperlipidemia3. Hypertension4. Obesity5. Low Back Pain6. Knee Pain7. Asthma8. Constipation9. Goiter10.Postmenstrual Syndrome

11. Diabetes Mellitus- Type II12. Acute Diarrhea13. Gastro-esophageal Reflux

Disease14. Osteoporosis15. Head Trauma16. Addiction17. Periodical Tests18. Angina Pectoris19. Dyspepsia20. Urinary Tract Infection

Convene a multidisciplinary panel to oversee the development of the guidelines

• Clinicians from all disciplines with relevant specialist expertise• Clinicians with general expertise• Other relevant health professionals• Representatives of consumer groups• Experts in research methods relevant to guideline development• Health economists• Public policy analysts• Other relevant experts• Industry representatives• Bioethicists• Representatives of regulatory agencies

Review the scientific evidence

• If possible, a systematic literature review should be undertaken to establish the benefits and harms of the possible interventions.

• Methods for reviewing and evaluating the literature range from highly formal,quantitative information syntheses (such as meta-analysis of randomized controlled trials) to subjective synopses of observational data.

• The more formal the review, the more credible and valid the resulting guidelines. The panel should select the most rigorous and systematic review methods practicable

Formulate the guidelines

• The panel should consider the following:– The natural history of the disease or condition in question, if

appropriate;– The probable outcomes of each intervention, taking into account the

strength of evidence associated with each, with preference given to empirical evidence over expert judgment;

– The balance of benefits against risks;– A comparison between the outcomes for alternative interventions,

including conservative or expectant management where appropriate, for the disease or condition in question; and

– An economic appraisal of the best investment for the best health outcomes

Characteristics of LCPGs

• Consider a “to do list”• Consider a “not to do list”• Consider Conditional “if then” Statements• Avoid Controversies• Notify Warning Signs (Red Flags)• Mention Indications for Referral• Mention Cost of Selected Alternatives• Include Emergency Care• Mention Life Style Changes when Applicable• Minimal if any Physiopathology• No Level of Evidence and Grade of Recommendation• No Referral to Original Articles

Guideline Framework• Epidemiology and Importance

– Prevalence and Incidence– Burden of Disease– Cost of Illness– Economic Influence

• Definitions (when applicable)• Investigation and Diagnosis

– History– Physical Examination– Para clinic

• Treatment and Management– Life Style Changes– General Recommendations– Drug Treatment

• Follow up• Referral and Inter-professional Coordination• Prevention (when applicable)• Screening (when applicable)• Patient Education• Quality Indicators

GroupComposition

Systematic Review and Drafting Recommendations

Consultation and Peer Review

Public-ation

6 months 12 months 9 months 3 months

Average Timescale for Guideline Development

GUIDELINE DISSEMINATION AND IMPLEMENTATION

Dr. Shahram Yazdani

• Field and Lohr make the important point that ‘guidelines do not implement themselves’ (1992).

• If guidelines are to be effective, their dissemination and implementation must be vigorously pursued.

• If not, the time, energy and cost devoted to the guidelines’ development will be wasted and potential improvements in consumer health will be lost.

Implementation Panel

• A multidisciplinary panel should oversee the various steps needed to disseminate and implement the guidelines.

• The panel, should also identify any barriers to the guidelines’ acceptance and implementation and work with members of target groups to develop ways of overcoming these barriers.

1. As Booklets2. In professional journals;3. In professional associations’ newsletters and magazines;4. In trade publications and industry newspapers;5. In the popular media;6. As brochures7. On the Internet and linked to websites appropriate for the target audience;8. As audio or video tapes; 9. On computer disks.

Awareness PreparationPractice Change

Reinforcement

Publishing the Guidelines

1. Posting out guidelines2. Using national, regional and local media;3. Publicity in trade publications and possibly writing articles for them;4. Publicity through professional associations and their publications 5. Publicity in professional journals;6. Publicity through consumer groups and their publications;7. Contact with undergraduate and postgraduate educators;


Reinforcement


Informing the target audience

8. Contact with undergraduate and postgraduate students;9. Publicity through institutions such as colleges, hospitals, 10. Discussion at conferences, seminars and professional meetings;11. Using ‘champions’ or local authorities to promote the guidelines or to be interviewed 12. Identifying ‘human interest’ stories for guidelines.


Reinforcement



1. Including in Undergraduate Medical Education2. Continuous Medical Education3. Educational Materials4. Seminars and Conferences5. Web Based Materials6. Interactive Educational Meetings


Reinforcement



Education

1. Including only technically efficient drugs for each problem in “national pharmacopoeia”2. “Insurance pharmacopoeia” according to allocative efficiency of interventions3. Considering “Pharmacopoeia in use” through sophisticated drug logistic strategies


Reinforcement



EducationAvailability AccessibilityAffordability

1. Perfect Practice Prize2. Naming 5 Star GPs in Professional Media3. Payment Bonuses4. Incentives for organizations within them CPGs are adopted and implemented5. Incentives for Provinces within them CPGs are mostly Implemented


Reinforcement




Incentive Strategies


Reinforcement



1. Setting Regulatory Clinical Standards2. Mandatory Registration of Patients with Disease of Interest in Registration

Books3. Performance Monitoring4. Clinical Audit5. Feedback Messages (according to audit results)6. Practice Reminders (eg on report of laboratory or radiology orders)7. Prescription Feedbacks8. Re-evaluation and Re-certification


Incentive Strategies

ClinicalGovernance

Evidence based implementation

Consistently effective: Educational outreach Reminders Multi-faceted Interactive meetings

Variable effectiveness: Audit + feedback Opinion leaders Consensus processes Patient mediated

Little or no effect:

Distribution of educational materials

Didactic educational meetings

Clinical Practice Guidelines for selected clinical topics in Islamic Republic of Iran Dr. Shahram...

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