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National Clinical Guideline Centre (UK). Hypertension: The Clinical Management of Primary Hypertension in Adults: Update of Clinical Guidelines 18 and 34 [Internet]. London: Royal College of Physicians (UK); 2011 Aug. (NICE Clinical Guidelines, No. 127.)

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Hypertension: The Clinical Management of Primary Hypertension in Adults: Update of Clinical Guidelines 18 and 34 [Internet].

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Appendix EReview protocols

E.1. Review protocol for the diagnosis of hypertension and monitoring treatment efficacy

  • Predicting outcome using clinic, home and ambulatory measurements
  • Sensitivity and specificity of clinic, home and ambulatory measurements
  • Measuring response to treatment using clinic, home and ambulatory measurements
Review questionsAMB1: In adults with suspected primary hypertension, what is the best method to measure blood pressure (home vs ambulatory vs office) to establish the diagnosis and predict the development of CV events?

AMB2: In adults with treated primary hypertension, what is the best method to measure blood pressure (home vs ambulatory vs office) for response to treatment and to predict the development of CV events?
ObjectivesThis aim of this review is to estimate the accuracy and cost-effectiveness of BP measurements (home vs ambulatory vs. office) for establishing the diagnosis of and prognosis in adults ≥18 years old with suspected primary hypertension; and for establishing response to treatment in adults ≥18 years old with treated primary hypertension.
CriteriaPopulation(s):
AMB1: Adults ≥18 years old with suspected primary hypertension who may or may not have pre-existing cardiovascular disease, chronic kidney disease and diabetes

AMB2: Adults ≥18 years old with treated primary hypertension who may or may not have pre-existing cardiovascular disease, chronic kidney disease and diabetes
Studies in indirect populations will not be considered (ocular HT, pulmonary HT, HT during pregnancy, acute HT, malignant HT, portal HT, renal HT and intercranial HT)
Studies in adult women of conception age will be considered (in accordance with BNF).
Studies with an exclusive diabetic or CKD population will be excluded (in accordance with the 2006 guideline exclusion criteria)

Intervention(s):
Home; ambulatory (and home vs. ambulatory)
Studies looking at home telemonitoring BP will be excluded, as this not common in clinical practice

Comparison(s):
Gold standard (office)

Outcome(s):
  • Risk of developing clinical outcomes:
  • Mortality
  • Stroke
  • MI Vascular procedures (including both coronary and arotid artery procedures)
  • Angina requiring hospitalisation
Major adverse cardiac and cerebrovascular events (MAACE): fatal and non-fatal MI, fatal a non-fatal stroke, hospitalised angina, hospitalised heart failure, revascularisation (AND DIFFERENT COMPOSITES OF THIS OUTCOME)

Studies will be excluded if they:
  • have no comparative BP measurement arm
  • are validation studies
  • are RCTs for treatment that have not monitored Tx throughout trial by ≥two different BP measurement methods (office or home or ABPM) and use two methods only at end of study
  • assess the prediction of future BP (rather than the specified clinical outcomes)
Search StrategySee Appendix D:Search Strategies.
Review StrategyStudy design: SRs / meta-analyses (will be included if they are published after the cut-off date of the previous guideline CG18, however the studies included within the SR/MA may have been published pre- and post- 2003); RCTs; non-RCTs: mainly diagnostic, prognostic and cohort studies

Taking into consideration the advice on prognostic reviews in the NICE guidelines manual, meta-analysis or GRADE will not be undertaken for prognostic studies as well as for other non-RCTs.

E.2. Review protocols for the diagnosis of hypertension: measurement protocols for diagnosing hypertension

Review questionsAMBU PROTOCOL: In adults with primary hypertension, what protocol should be used when measuring ambulatory BP for treatment and diagnosis?

HOME PROTOCOL: In adults with primary hypertension, what protocol should be used when measuring BP at home for treatment and diagnosis?
ObjectivesThis aim of this review is to establish the best protocols for measuring ambulatory BP and home BP for diagnosis of hypertension and for monitoring treatment (in adults ≥18 years old).
CriteriaPopulation (s):
Adults ≥18 years old with suspected primary hypertension (diagnosis) or hypertension (treatment) who may or may not have pre-existing cardiovascular disease, chronic kidney disease and diabetes
Studies in indirect populations will not be considered (ocular HT, pulmonary HT, HT during pregnancy, acute HT, malignant HT, portal HT, renal HT and intercranial HT)
Studies in adult women of conception age will be considered (in accordance with BNF).
Studies with an exclusive diabetic or CKD population will be excluded (in accordance with the 2006 guideline exclusion criteria)

Intervention (s) and comparison(s):
Home vs Home; ABPM vs ABPM
Studies looking at home telemonitoring BP will be excluded, as this not common in clinical practice
Studies will be selected from abstract lists if they mention more than 1 method or protocol of measuring home BP or if they directly assess what the optimum HBP protocol should be; otherwise they will be excluded at the abstracting stage.

Outcome(s):
  • Risk of developing clinical outcomes:
  • Mortality
  • Stroke
  • MI
  • Vascular procedures (including both coronary and arotid artery procedures)
  • Angina requiring hospitalisation
  • Major adverse cardiac and cerebrovascular events (MAACE): fatal and non-fatal MI, fatal and non-fatal stroke, hospitalised angina, hospitalised heart failure, revascularisation (AND DIFFERENT COMPOSITES OF THIS OUTCOME)
Studies will be excluded if they:
  • are validation studies
  • are prognostic studies that only give one of the following ABPM: day, night, 24hours. Need to compare all of them for which is best predictor
  • assess the prediction of future BP (rather than the specified clinical outcomes)
Search StrategySee appendix Appendix D:Search Strategies.
Review StrategyStudy design: SRs / meta-analyses (will be included if they are published after the cut-off date of the previous guideline CG18, however the studies included within the SR/MA may have been published pre- and post- 2003); RCTs; non-RCTs: mainly diagnostic, prognostic and cohort studies, reliability / reproducibility studies

Taking into consideration the advice on prognostic reviews in the NICE guidelines manual, meta-analysis or GRADE will not be undertaken for prognostic studies as well as for other non-RCTs.

E.3. Review protocol for initiating and monitoring treatment, including blood pressure targets

  • Blood pressure thresholds for initiating treatment
  • Blood pressure targets for treatment
  • Monitoring treatment (covered in AMB1 and AMB2 protocol, xxx)
  • Equivalent thresholds for intervention / treatment targets

Blood pressure thresholds for initiating treatment and blood pressure targets for treatment

Review questionsINITIATION: In adults with primary hypertension, at what BP should treatment be initiated?

OPTIMUM: In adults with primary hypertension, what is the optimum BP that should be reached for once treatment has been initiated/ targeted for treatment?
ObjectivesThis aim of this review is to determine the appropriate level (threshold) of BP that a person must have in order for treatment to be initiated, and to determine the appropriate BP that treatment should be targeted to in order to gain an appropriate reduction in risk of CV events.
CriteriaPopulation (s):
Adults ≥18 years old with suspected primary hypertension (diagnosis) or hypertension (treatment) who may or may not have pre-existing cardiovascular disease, chronic kidney disease and diabetes
Studies in indirect populations will not be considered (ocular HT, pulmonary HT, HT during pregnancy, acute HT, malignant HT, portal HT, renal HT and intercranial HT)
Studies in adult women of conception age will be considered (in accordance with BNF).
Studies with an exclusive diabetic or CKD population will be excluded (in accordance with the 2006 guideline exclusion criteria)

Intervention (s) and comparisons:
Home, ABPM and clinic

Outcome(s):
FOR INITIATION
  • Risk of developing clinical outcomes (at different BPs; studies will be excluded if they do not assess results by stratifying into different BP thresholds / values (thresholds or treatment targets)
  • Mortality
  • Stroke
  • MI
  • Vascular procedures (including both coronary and arotid artery procedures)
  • Angina requiring hospitalisation
  • Major adverse cardiac and cerebrovascular events (MAACE): fatal and non-fatal MI, fatal and non-fatal stroke, hospitalised angina, hospitalised heart failure, revascularisation (AND DIFFERENT COMPOSITES OF THIS OUTCOME)
FOR OPTIMUM
Same outcomes as above plus:
  • Number of patients with controlled BP
  • Number of patients reaching target
  • Final BP values
Studies will be excluded if they:
  • do not stratify results by different BP thresholds / values
  • compare treated vs. untreated patients (for OPTIMUM)
Search StrategySee appendix Appendix D:Search Strategies.
Review StrategyStudy design: SRs / meta-analyses (will be included if they are published after the cut-off date of the previous guideline CG18, however the studies included within the SR/MA may have been published pre- and post- 2003); RCTs; non-RCTs: mainly diagnostic, prognostic and cohort studies.

Taking into consideration the advice on prognostic reviews in the NICE guidelines manual, meta-analysis or GRADE will not be undertaken for prognostic studies as well as for other non-RCTs.

Equivalent thresholds for intervention / treatment targets

Review questionADJUST (AMB3): if used, should ambulatory or home blood pressure readings be interpreted differently to office measurements? i.e. are different thresholds for intervention/targets for treatment required, or should adjustment be made to readings.
ObjectivesTo establish the adjustment factor required for ambulatory, home and office BP measurements in order to give the same (in adults ≥18 years old).
CriteriaSee ‘review strategy’
Search StrategySee ‘review strategy’
Review StrategyFor this question data from the reviews comparing all three BP measurement methods (ABPM, home and clinic) were used to determine equivalent thresholds for intervention and targets for treatment based on outcome measures showing equivalent prognosis.

E.4. Review protocol for pharmacological interventions

  • Step one therapy: Angiotensin-converting enzyme inhibitors (ACEi) versus Angiotensin Receptor Blockers (ARB); Diuretics
  • Step two therapy: A+C vs A+D
  • Special groups for consideration: people aged over 80 years and ethnicity

Step-one therapy: ACEi vs ARBs

Review questionIn adults with primary hypertension, which is the most clinically and cost effective anti- hypertensive monotherapy (ACEi vs ARB) for first-line treatment, and does this vary with age and ethnicity?
ObjectivesSince the publication of the earlier HT guidelines, a major outstanding issue for first line therapy was A vs A (as there was no evidence for these comparisons). Recent evidence has now emerged directly comparing ACEi and ARB. Therefore the aim of this review is to estimate the efficacy, safety and cost-effectiveness of ACEi vs ARB for first-line treatment of adults ≥18 years old with primary hypertension.
CriteriaPopulation (s):
Adults ≥18 years old with primary hypertension who may or may not have pre-existing cardiovascular disease, chronic kidney disease and diabetes
Studies in indirect populations will not be considered (ocular HT, pulmonary HT, HT during pregnancy, acute HT, malignant HT, portal HT, renal HT and intercranial HT)
Studies in adult women of conception age will be considered (in accordance with BNF).
Studies with an exclusive diabetic or CKD population will be excluded (in accordance with the 2006 guideline exclusion criteria)
Intervention (s):
ACEi*
Comparison(s):
ARB*
*In accordance with the 2006 guideline, all drugs in these classes will be assessed (licensed and unlicensed) as we are assuming a class effect
Outcome(s):
Effectiveness10%
• Mortality from any cause
• Stroke (ischaemic or haemorrhagic)10%
• Myocardial infarction (MI) (including, where reported, silent MI)
Heart failure
• New onset diabetes
• Vascular procedures (including both coronary and carotid artery procedures)
• Angina requiring hospitalisation
• Health-related quality of life (to use what is reported by trials)
• Major adverse cardiac and cerebrovascular events (MAACE): fatal and non-fatal MI, fatal and non-fatal stroke, hospitalised angina, hospitalised heart failure, revascularisation (AND DIFFERENT COMPOSITES OF THIS OUTCOME)
10%
Safety
  • Study drug withdrawal rates (surrogate for adverse effects of drug treatment and for adherence)
  • Angioodema in black people of African and Caribbean descent
Search StrategySee appendix Appendix D:Search Strategies.
Review StrategyStudy design: SRs / meta-analyses (will be included if they are published after the cut-off date of the previous guideline CG34, however the studies included within the SR/MA may have been published pre- and post- 2006); RCTs.
Where appropriate, meta-analysis will be undertaken.
Subgroup analyses will be done for age >80 years (vs <80 years) and for black people of African and Caribbean descent (vs. white people)
Sensitivity analysis will be carried out based on methodological quality if significant heterogeneity exists.
Overall assessment of the quality (for each outcome) will be undertaken using GRADE.
Studies will be excluded if they:
  • have sample size of N<200 (in accordance with the 2006 guideline exclusion criteria)
  • have follow-up time of <12 months (in accordance with the 2006 guideline exclusion criteria)

Step-one therapy: diuretics

Review questionIn adults with primary hypertension, which is the most clinically and cost effective thiazide diuretic (bendrofluazide / bendroflumethiazide, chlorthalidone, indapamide, hydrochlorothiazide) for first-line treatment, and does this vary with age and ethnicity?
ObjectivesA major issue for first line therapy is which diuretic is most effective because in the UK we use bendrofluazide for which there is very little evidence and the rest of the world do not use this drug. Is there a better diuretic to use? This was not looked at in the previous guidelines and so we have searched all dates. Therefore the aim of this review is to to estimate the efficacy, safety and cost-effectiveness of specific diuretics (bendrofluazide / bendroflumethiazide, chlorthalidone, indapamide, hydrochlorothiazide) for first-line treatment of adults ≥18 years old with primary hypertension.
CriteriaPopulation (s):
Adults ≥18 years old with primary hypertension who may or may not have pre-existing cardiovascular disease, chronic kidney disease and diabetes
Studies in indirect populations will not be considered (ocular HT, pulmonary HT, HT during pregnancy, acute HT, malignant HT, portal HT, renal HT and intercranial HT)
Studies in adult women of conception age will be considered (in accordance with BNF).
Studies with an exclusive diabetic or CKD population will be excluded (in accordance with the 2006 guideline exclusion criteria)
Intervention (s):
TD / TDLs (bendrofluazide / bendroflumethiazide, chlorthalidone, indapamide, hydrochlorothiazide)
Comparison(s):
TD/TDLs (head-to head – using the four named drugs above), placebo, other a-HT drug classes (BB, CCB, ACEi, ARBs: all drugs – licensed and unlicensed as we are assuming a class effect)
Outcome(s):
Effectiveness10%
• Mortality from any cause
• Stroke (ischaemic or haemorrhagic)10%
• Myocardial infarction (MI) (including, where reported, silent MI)
Heart failure
• New onset diabetes
• Vascular procedures (including both coronary and carotid artery procedures)
• Angina requiring hospitalisation
• Health-related quality of life (to use what is reported by trials)
• Major adverse cardiac and cerebrovascular events (MAACE): fatal and non-fatal MI, fatal and non-fatal stroke, hospitalised angina, hospitalised heart failure, revascularisation (AND DIFFERENT COMPOSITES OF THIS OUTCOME)
• BP lowering (for part 2 of the question only – see review strategy section)
10%
Safety
  • Study drug withdrawal rates (surrogate for adverse effects of drug treatment and for adherence)
  • Angioodema in black people of African and Caribbean descent
Search StrategySee appendix Appendix D:Search Strategies.
Review StrategyStudy design: SRs / meta-analyses (will be included if they are published after the cut-off date of the previous guideline CG34, however the studies included within the SR/MA may have been published pre- and post- 2006); RCTs.
Where appropriate, meta-analysis will be undertaken.
Subgroup analyses will be done for age >80 years (vs <80 years) and for black people of African and Caribbean descent (vs. white people)
Sensitivity analysis will be carried out based on methodological quality if significant heterogeneity exists.
Overall assessment of the quality (for each outcome) will be undertaken using GRADE.
Review strategy for part 1 and 2 of the question:
PART 1: TDs/TDLs vs placebo or other a-HT drug classes
TDs/TDLs must be: bendrofluazide / bendroflumethiazide, chlorthalidone, indapamide, hydrochlorothiazide
Sample size must be N>200 (in accordance with the 2006 guideline exclusion criteria
Follow up must be ≥1 year (in accordance with the 2006 guideline exclusion criteria
Outcomes must be clinical only (not BP)
Exclude studies if they report AEs / withdrawals but not our pre-specified clinical outcomes
PART 2: Head-to-head - TDs/TDLs vs other TDs/TDLs
TDs/TDLs must be: bendrofluazide / bendroflumethiazide, chlorthalidone, indapamide, hydrochlorothiazide
Sample size: any
Follow up: any
Outcomes: BP only (only use clinical if reported ≥1 year results)

Step-two therapy

Review questionCOMBI: In adults with primary hypertension, which is the most clinically and cost effective combination of anti-hypertensives (A+C or A+D) for second line treatment, and does this vary with age and ethnicity?
ObjectivesThe earlier HT guideline recommended the use of adding in either CCBs or D for second-line therapy (ie. A+C or A+D). Recent evidence has now emerged directly comparing these combinations. The aim of this review is therefore to estimate the efficacy, safety and cost-effectiveness of ACEi + CCB or ARB + CCB vs. ACE + Diuretic or ARB + Diuretic) for second-line treatment of adults ≥18 years old with primary hypertension.
CriteriaPopulation (s):
Adults ≥18 years old with primary hypertension who may or may not have pre-existing cardiovascular disease, chronic kidney disease and diabetes
Studies in indirect populations will not be considered (ocular HT, pulmonary HT, HT during pregnancy, acute HT, malignant HT, portal HT, renal HT and intercranial HT)
Studies in adult women of conception age will be considered (in accordance with BNF).
Studies with an exclusive diabetic or CKD population will be excluded (in accordance with the 2006 guideline exclusion criteria)
Intervention (s):
A (ACEi or ARB)* + CCB* in second line treatment
Comparison(s):
A (ACEi or ARB)* + D* in second line treatment
*In accordance with the 2006 guideline, all drugs in these classes will be assessed (licensed and unlicensed) as we are assuming a class effect
Outcome(s):
Effectiveness10%
• Mortality from any cause
• Stroke (ischaemic or haemorrhagic)10%
• Myocardial infarction (MI) (including, where reported, silent MI)
Heart failure
• New onset diabetes
• Vascular procedures (including both coronary and carotid artery procedures)
• Angina requiring hospitalisation
• Health-related quality of life (to use what is reported by trials)
• Major adverse cardiac and cerebrovascular events (MAACE): fatal and non-fatal MI, fatal and non-fatal stroke, hospitalised angina, hospitalised heart failure, revascularisation (AND DIFFERENT COMPOSITES OF THIS OUTCOME)
10%
Safety
  • Study drug withdrawal rates (surrogate for adverse effects of drug treatment and for adherence)
  • Angioodema in black people
Search StrategySee appendix Appendix D:Search Strategies.
Review StrategyStudy design: SRs / meta-analyses (will be included if they are published after the cut-off date of the previous guideline CG18, however the studies included within the SR/MA may have been published pre- and post- 2003); RCTs.
Where appropriate, meta-analysis will be undertaken.
Subgroup analyses will be done for age >80 years (vs <80 years) and for black people of African and Caribbean descent (vs. white people)
Sensitivity analysis will be carried out based on methodological quality if significant heterogeneity exists.
Overall assessment of the quality (for each outcome) will be undertaken using GRADE.
Studies will be excluded if they:
  • have sample size of N<200 (in accordance with the 2004 guideline exclusion criteria)
  • have follow-up time of <12 months (in accordance with the 2004 guideline exclusion criteria)

Resistant hypertension

Review questionIn adults with resistant hypertension, which is the most clinically and cost effective fourth-line pharmacological treatment, and does this vary with age and ethnicity?
ObjectivesResistant hypertension has not been covered in the previous guidelines. The aim of this review is therefore to estimate the efficacy, safety and cost-effectiveness of fourth-line therapy in adults ≥18 years old with resistant hypertension.
CriteriaPopulation (s):
Adults (≥18 years old) with resistant hypertension (people whose BP is still uncontrolled despite treatment with optimal doses of three a-HT drugs) who may or may not have pre-existing cardiovascular disease, chronic kidney disease and diabetes
Studies in indirect populations will not be considered (ocular HT, pulmonary HT, HT during pregnancy, acute HT, malignant HT, portal HT, renal HT and intercranial HT)
Studies in adult women of conception age will be considered (in accordance with BNF).
Studies with an exclusive diabetic or CKD population will be excluded (in accordance with the 2006 guideline exclusion criteria)
Intervention (s):
4th line drugs (MOST WIDELY USED OPTIONS: including alpha-blockers; beta-blockers; other/further diuretics such as amiloride and spironolactone; aliskerin; aldosterin antagonists; moxonidine )
Comparison(s):
Any comparison (placebo or each other)
Outcome(s):
Effectiveness10%
• Mortality from any cause
• Stroke (ischaemic or haemorrhagic)10%
• Myocardial infarction (MI) (including, where reported, silent MI)
Heart failure
• New onset diabetes
• Vascular procedures (including both coronary and carotid artery procedures)
• Angina requiring hospitalisation
• Health-related quality of life (to use what is reported by trials)
• Major adverse cardiac and cerebrovascular events (MAACE): fatal and non-fatal MI, fatal and non-fatal stroke, hospitalised angina, hospitalised heart failure, revascularisation (AND DIFFERENT COMPOSITES OF THIS OUTCOME)
10%
Safety
  • Study drug withdrawal rates (surrogate for adverse effects of drug treatment and for adherence)
  • Angioodema in black people
Search StrategySee appendix Appendix D:Search Strategies.
Review StrategyStudy design: SRs / meta-analyses (will be included if they are published after the cut-off date of the previous guideline CG18, however the studies included within the SR/MA may have been published pre- and post- 2003); RCTs; cohort studies.
Where appropriate, meta-analysis will be undertaken.
Subgroup analyses will be done for age >80 years (vs <80 years) and for black people of African and Caribbean descent (vs. white people)
Sensitivity analysis will be carried out based on methodological quality if significant heterogeneity exists.
Overall assessment of the quality (for each outcome) will be undertaken using GRADE.
Studies will be excluded if they:
  • are RCTs with a sample size of N<200 (in accordance with the 2004 guideline exclusion criteria); unless evidence is sparse
  • are RCTs with a follow-up time of <12 months (in accordance with the 2004 guideline exclusion criteria); unless evidence is sparse

Special groups for consideration: people aged over 80 years

Review questionIn adults with primary hypertension, what is the most clinically and cost effective first-line anti-hypertensive treatment (drug classes) in elderly people (aged ≥80 years)?
ObjectivesIn the previous guidelines (CG18 and CG34) there was no evidence available showing whether there were differences in treatment effects in elderly people (80+). However data has since then emerged on drug treatment in this age-group. Therefore the aim of this review is to to estimate the efficacy, safety and cost-effectiveness of anti-hypertensive drugs for the first-line treatment of adults ≥80 years old with primary hypertension.
CriteriaPopulation (s):
Adults ≥80 years old with primary hypertension who may or may not have pre-existing cardiovascular disease, chronic kidney disease and diabetes
Studies in indirect populations will not be considered (ocular HT, pulmonary HT, HT during pregnancy, acute HT, malignant HT, portal HT, renal HT and intercranial HT)
Studies in adult women of conception age will be considered (in accordance with BNF).
Studies with an exclusive diabetic or CKD population will be excluded (in accordance with the 2006 guideline exclusion criteria)
Intervention (s):
All a-HT drug classes (BB, CCB, ACEi, ARBs)*
Comparison(s): all a-HT drug classes (BB, CCB, ACEi, ARBs)*
*In accordance with the 2006 guideline, all drugs in these classes will be assessed (licensed and unlicensed) as we are assuming a class effect
Outcome(s):
Effectiveness10%
• Mortality from any cause
• Stroke (ischaemic or haemorrhagic)10%
• Myocardial infarction (MI) (including, where reported, silent MI)
Heart failure
• New onset diabetes
• Vascular procedures (including both coronary and carotid artery procedures)
• Angina requiring hospitalisation
• Health-related quality of life (to use what is reported by trials)
• Major adverse cardiac and cerebrovascular events (MAACE): fatal and non-fatal MI, fatal and non-fatal stroke, hospitalised angina, hospitalised heart failure, revascularisation (AND DIFFERENT COMPOSITES OF THIS OUTCOME)
10%
Safety
  • Study drug withdrawal rates (surrogate for adverse effects of drug treatment and for adherence)
  • Angioodema in black people of African and Caribbean descent
Search StrategySee appendix Appendix D:Search Strategies.
Review StrategyStudy design: SRs / meta-analyses (will be included if they are published after the cut-off date of the previous guideline CG34, however the studies included within the SR/MA may have been published pre- and post- 2006); RCTs.
Where appropriate, meta-analysis will be undertaken.
Sensitivity analysis will be carried out based on methodological quality if significant heterogeneity exists.
Overall assessment of the quality (for each outcome) will be undertaken using GRADE.
Studies will be excluded if they:
  • have sample size of N<200 (in accordance with the 2006 guideline exclusion criteria)
  • have follow-up time of <12 months (in accordance with the 2006 guideline exclusion criteria)

Special groups for consideration: ethnicity

Review questionIn adults with primary hypertension, what is the most clinically and cost effective first-line anti-hypertensive treatment (drug classes) in black people of African or Caribbean descent)?
ObjectivesIn the previous guideline there was little evidence available showing whether there were differences in treatment effects in elderly people (80+). However data has since then emerged on drug treatment in this age-group. Therefore the aim of this review is to to estimate the efficacy, safety and cost-effectiveness of anti-hypertensive drugs for the first-line treatment of adults ≥80 years old with primary hypertension.
CriteriaPopulation (s):
Black adults (of African or Caribbean descent) ≥18 years old with primary hypertension who may or may not have pre-existing cardiovascular disease, chronic kidney disease and diabetes
Studies in indirect populations will not be considered (ocular HT, pulmonary HT, HT during pregnancy, acute HT, malignant HT, portal HT, renal HT and intercranial HT)
Studies in adult women of conception age will be considered (in accordance with BNF).
Studies with an exclusive diabetic or CKD population will be excluded (in accordance with the 2006 guideline exclusion criteria)
Intervention (s):
ACEi*
Comparison(s):
ARB*
*In accordance with the 2006 guideline, all drugs in these classes will be assessed (licensed and unlicensed) as we are assuming a class effect
Outcome(s):
Effectiveness10%
• Mortality from any cause
• Stroke (ischaemic or haemorrhagic)10%
• Myocardial infarction (MI) (including, where reported, silent MI)
Heart failure
• New onset diabetes
• Vascular procedures (including both coronary and carotid artery procedures)
• Angina requiring hospitalisation
• Health-related quality of life (to use what is reported by trials)
• Major adverse cardiac and cerebrovascular events (MAACE): fatal and non-fatal MI, fatal and non-fatal stroke, hospitalised angina, hospitalised heart failure, revascularisation (AND DIFFERENT COMPOSITES OF THIS OUTCOME)
10%
Safety
  • Study drug withdrawal rates (surrogate for adverse effects of drug treatment and for adherence)
  • Angioodema
Search StrategySee appendix Appendix D:Search Strategies.
Review StrategyStudy design: SRs/meta-analyses (will be included if they are published after the cut-off date of the previous guideline CG34, however the studies included within the SR/MA may have been published pre- and post- 2006); RCTs; sub-group analyses of RCTs, cohort studies.
Where appropriate, meta-analysis will be undertaken.
Sensitivity analysis will be carried out based on methodological quality if significant heterogeneity exists.
Overall assessment of the quality (for each outcome) will be undertaken using GRADE.
Studies will be excluded if they have a:
  • sample size of N<1000 in each arm (as a very large study, ALLHAT, has been published with a sample size of 42,418)
  • follow-up time of <12 months (in accordance with the 2006 guideline exclusion criteria)

E.4.1. Health economic review protocol

Review questionAll questions – health economic evidence
ObjectivesTo identify economic studies relevant to the review questions set out above.
CriteriaPopulations, interventions and comparators, and date cut-offs as specified in the question-specific review protocols. Must be a relevant economic study design (cost-utility analysis, cost-benefit analysis, cost-effectiveness analysis, cost-consequence analysis, comparative cost analysis).
Search strategySee Appendix D:.
Review strategyEach study is assessed using the NICE economic evaluation checklist – NICE (2009) Guidelines Manual, Appendix H.

Inclusion/exclusion criteria
  • If a study is rated as both ‘Directly applicable’ and ‘Minor limitations’ (using the NICE economic evaluation checklist) then it should be included in the guideline. An evidence table should be completed and it should be included in the economic profile.
  • If a study is rated as either ‘Not applicable’ or ‘Very serious limitations’ then it should be excluded from the guideline. It should not be included in the economic profile and there is no need to include an evidence table.
  • If a study is rated as ‘Partially applicable’ and/or ‘Potentially serious limitations’ then there is discretion over whether it should be included. The health economist should make a decision based on the relative applicability and quality of the available evidence for that question, in discussion with the GDG if required. The ultimate aim being to include studies that are helpful for decision making in the context of the guideline. Where exclusions occur on this basis, this should be noted in the relevant section of the guideline with references.
Also exclude:
  • unpublished reports unless submitted as part of the call for evidence
  • abstract-only studies
  • letters
  • editorials
  • reviews of economic evaluations(a)
  • foreign language articles
Where there is discretion
The health economist should be guided by the following hierarchies.

Setting:
  1. UK NHS
  2. OECD countries with predominantly public health insurance systems (e.g. France, Germany, Sweden)
  3. OECD countries with predominantly private health insurance systems (e.g. USA, Switzerland)
  4. Non-OECD settings (always ‘Not applicable’)
Economic study type:
  1. Other type of full economic evaluation (cost-benefit analysis, cost-effectiveness analysis, cost-consequence analysis)
  2. Comparative cost analysis
  3. Non-comparative cost analyses including cost of illness studies (always ‘Not applicable’)
Year of analysis:
  • The more recent the study, the more applicable it is
Quality and relevance of effectiveness data used in the economic analysis:
  • The more closely the effectiveness data used in the economic analysis matches with the studies included for the clinical review the more useful the analysis will be to decision making for the guideline.
a

Recent reviews will be ordered although not reviewed. The bibliographies will be checked for relevant studies, which will then be ordered.

Recent reviews will be ordered although not reviewed. The bibliographies will be checked for relevant studies, which will then be ordered.

Copyright © 2011, National Clinical Guideline Centre.

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