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Matchar DB, McCrory DC, Orlando LA, et al. Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin II Receptor Antagonists (ARBs) for Treating Essential Hypertension [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2007 Nov. (Comparative Effectiveness Reviews, No. 10.)

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Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin II Receptor Antagonists (ARBs) for Treating Essential Hypertension [Internet].

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Appendix FApplicability Criteria

Instructions to abstractors/assessors: Do not assign an overall applicability score. Instead, list the most important (up to 3) limitations affecting applicability, if any, based on the following list.

Setting of the study

(1) In which country (or countries) was the study conducted?

(2) In what health care system (or systems) was the study conducted?

(3) Were patients recruited from the primary, secondary, or tertiary care settings?

(4) How were study centers selected for participation?

(5) How were study clinicians selected for participation?

Selection of participants

(6) How were participants diagnosed and identified for eligibility screening before random allocation?

(7) What were the study eligibility criteria?

(8) What were the study exclusion criteria?

(9) Did the study require a run-in period with the control or placebo intervention?

(10) Did the study require a run-in period with the active intervention?

(11) Did the study selectively recruit participants who demonstrated a history of favorable or unfavorable response to drug or other interventions for the condition?

(12) Did the study report the ratio of randomly allocated participants to nonallocated participants (who were eligible)?

(13) Did the study report the proportion of eligible participants who declined random allocation?

Characteristics of study participants

(14) Did the study report participants’ baseline characteristics?

(15) Did the study report participants’ race?

(16) Did the study report participants’ underlying pathology?

(17) Did the study report participants’ stage in the natural history of the disease?

(18) Did the study report participants’ severity of disease?

(19) Did the study report participants’ comorbid conditions?

(20) Did the study report participants’ absolute risk of a poor outcome in the control arm?

Differences between the study protocol and routine clinical practice

(21) Were the study interventions (active arm) similar to interventions used in routine clinical practice?

(22) Was the timing of the intervention similar to the timing in routine clinical practice?

(23) Was the study’s control arm appropriate and relevant in relation to routine clinical practice?

(24) Were the study’s cointerventions—which were not randomly allocated—adequate to reflect routine clinical practice?

(25) Were any interventions prohibited by the study that are routinely used in clinical practice?

(26) Have there been diagnostic or therapeutic advances used in routine practice since the study was conducted?

Outcome measures and followup

(27) If applicable, did the study use a clinically relevant surrogate outcome?

(28) If applicable, did the study use a scale that is clinically relevant, valid, and reproducible?

(29) If applicable, was the intervention beneficial on the most relevant components of the composite outcome?

(30) Which clinician measured the outcome (e.g., treating physician or surgeon)?

(31) Did the study use patient-centered outcomes?

(32) How frequently were participants followed in the study?

(33) Was the duration of participant followup adequate?

Adverse effects of treatment

(34) How completely did the study report the occurrence of relevant adverse effects?

(35) Did the study report the rates of treatment discontinuations?

(36) Were the study centers and/or clinicians selected on the basis of their skill or experience?

(37) Did the study exclude participants at elevated risk of intervention complications?

(38) Did the study exclude participants who suffered adverse effects during the run-in period?

(39) Did the study monitor participants intensively for early signs of adverse effects?

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