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Research

Enhanced hypertension care through private clinics in Pakistan: a cluster randomised trial

Muhammad Amir Khan, Nida Khan, John D Walley, Shaheer Ellahi Khan, Joseph Hicks, Faisal Imtiaz Sheikh, Muhammad Ahmar Khan, Muhammad Ali, Maqsood Ahmed, Haroon Jehangir Khan and Rony Zachariah
BJGP Open 2019; 3 (1): bjgpopen18X101617. DOI: https://doi.org/10.3399/bjgpopen18X101617
Muhammad Amir Khan
1Chief Coordinating Professional, Association for Social Development, , Pakistan
DHA, MPH, PhD, FFPH
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Nida Khan
2Project Coordinator, Association for Social Development, , Pakistan
MSc, MS
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  • For correspondence: nidakhan{at}asd.com.pk
John D Walley
3Professor of International Public Health, Nuffield Centre for International Health and Development, Leeds Institute of Health Sciences, University of Leeds, , UK
MComH, FFPH, MRCGP
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Shaheer Ellahi Khan
4Assistant Professor, Humanities and Social Sciences Department, Bahria University, , Pakistan
MSc, MPhil
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Joseph Hicks
5Senior Medical Statistician, Nuffield Centre for International Health and Development, Leeds Institute of Health Sciences, , UK
MSc, PhD
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Faisal Imtiaz Sheikh
6Research Coordinator, Association for Social Development, , Pakistan
MS, PharmD
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Muhammad Ahmar Khan
7Research Coordinator, Association for Social Development, , Pakistan
MBBS
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Muhammad Ali
8Research Assistant, Association for Social Development, , Pakistan
BA
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Maqsood Ahmed
9Senior Professional, Association for Social Development, , Pakistan
MBBS, MPhil (Public Health)
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Haroon Jehangir Khan
10Director, NCD & Mental Health, Directorate General of Health Services, , Pakistan
BSc, MA HMPP, MPH, FRIPH
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Rony Zachariah
11General Coordinator and Strategic Advisor, Operational Research, Médecins Sans Frontières, , Belgium
MD, PhD, DTM&H, DCH
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Article Figures & Data

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    Figure 1. CONSORT trial flow chart

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    Table 1. Baseline characteristics
    CharacteristicsIntervention, n (%)Control, n (%)
    Clusters
    Total13 (50.0)13 (50.0)
    Doctors
    Male13 (100.0)13 (100.0)
    Female0 (0.0)0 (0.0)
    Paramedics
    Male13 (100.0)13 (100.0)
    Female0 (0.0)0 (0.0)
    Participants
    Total574 (50.4)564 (49.6)
    Mean cluster size (SD)44.15 (33.22)43.38 (27.96)
    Sex
    Male290 (50.5)268 (47.5)
    Female284 (49.5)296 (52.5)
    Mean age, years (SD)45.69 (11.72)44.60 (12.40)
    Mean education, years (SD)6.5 (4.8)6.1 (4.4)
    Mean BMI, kg/m2 (SD)27.52 (5.85)26.49 (5.67)
    Hypertensive574 (100)564 (100)
    Smoker71 (12.4)90 (16.0)
    Mean fasting blood sugar, mg/dL (SD)134.69 (56.06)141.88 (55.81)
    Mean random blood sugar, mg/dL (SD)151.99 (70.73)140.78 (62.43)
    Mean HbA1c (%)8.28 (2.51)8.026 (2.58)
    Mean systolic blood pressure, mmHg (SD)161.25 (13.28)161.42 (16.38)
    Mean diastolic blood pressure, mmHg (SD)103.60 (8.91)103.48 (9.02)
    Mean serum cholesterol, mg/dL (SD)195.06 (45.38)185.95 (44.03)
    • Hypertensive defined as baseline SBP >140 mmHg.

    • View popup
    Table 2. Primary and secondary outcomes
    Intervention, 
    mean outcome (95% CI)
    (clusters n = 13)
    Control, 
    mean outcome (95% CI)
    (clusters n = 13)
    Crude control-intervention difference (95% CI); P valuebAdjusted control-intervention difference (95% CI); P valueb
    Change in SBP, mmHgc-25.23 
    (-29.86 to -20.61)
    -9.41 
    (-21.24 to 2.24)
    15.82 
    (3.60 to 28.04); 0.01
    12.63 (0.68 to 24.57); 0.04
    Change in DBP, mmHgc-18.18 
    (-22.12 to -14.25)
    -8.62 
    (-15.00 to -2.24)
    9.57 
    (2.39 to 16.74); 0.01
    7.58 
    (0.61 to 14.55); 0.04
    Hypertension control, %d69.56 
    (57.09 to 82.03)
    35.79 
    (15.44 to 56.13)
    -34pp 
    (-56 to -11); 0.01
    -30pp
    (-53 to -6); 0.02
    Change in HbA1c, %c-0.70pp 
    (-2.02 to 0.61)
    -1.71pp 
    (-2.63 to -0.79)
    1.01pp 
    (-2.53 to 0.52); 0.18
    0.59pp 
    (-0.29 to 0.17); 0.60
    Glycaemic control, %e33.03 
    (10.11 to 55.94%)
    42.79 
    (27.22 to 58.36%)
    10pp 
    (-17 to 36); 0.45
    3pp 
    (-2 to 87); 0.19
    Change in total serum cholesterol (mg/dL)c-27.69 
    (-31.69 to -23.69)
    0.52 
    (-9.85 to 10.89)
    28.21 
    (17.37 to 39.06); 0.001
    22.52 
    (15.89 to 29.16); 0.001
    Treatment adherencef73.11 
    (56.34 to 89.88)
    18.60 
    (6.63 to 30.57)
    -54.51 
    (-74.13 to -34.88); 0. 00
    -53.57 
    (-77.68 to -29.46); 0.00
    Smoking cessation3.08 
    (0.78 to 5.38)
    4.17 
    (1.74 to 6.62)
    1.10 
    (-2.08 to 4.28); 0.48
    0.03 
    (-1.37 to 1.43); 0.97
    • DBP = diastolic blood pressure. pp = percentage points. SBP = systolic blood pressure. aArm-specific mean outcomes and their 95% confidence intervals are themselves based on cluster-level summary (mean/proportion) outcomes. bAll control minus intervention differences (that is, intervention effect estimates) are based on analysis of crude/covariate-adjusted cluster-level summary (mean/proportion) outcomes. cAll change outcomes are calculated as outcome at endpoint minus outcome at baseline. dHypertension control defined as endpoint systolic BP ≤140 mmHg; eGlycaemic control defined as endpoint HbA1c ≤7%. fTreatment adherence was defined as patient having attended ≥5 treatment visits. All differences for percentage outcomes are on the absolute scale as percentage points. All analyses use only complete cases.

    • View popup
    Table 3. Effect modification by sex for the primary outcome (change in SBP)
    Mean outcome (95% CI)a
    Intervention
    (clusters n = 13)
    Control 
    (clusters n = 13)
    Crude effect (95% CI); P valuebAdjusted effect (95% CI); P value
    Female change in SBP-25.62
    (-30.49
     to -20.75)
    -10.42
    (-21.92 to 1.09)
    15.20
    (3.06 to 27.34); 0.02
    13.32
    (0.74 to 25.89); 0.04
    Male change in SBP-24.64
    (-29.33
     to -19.95)
    -7.52
    (-23.42 to 8.39)
    17.13
    (0.81 to 33.44); 0.04
    17.51
    (3.69 to 31.34); 0.02
    Female–male
    difference
    for change in SBP
    ---1.93
    (-12.38 to 8.53); 0.70
    -0.50
    (-9.27 to 8.27); 0.90
    • SBP = systolic blood pressure. aArm-specific mean outcomes and their 95% confidence intervals are themselves based on cluster-level summary mean outcomes for females/males/female–male differences. bAll control minus intervention differences (intervention effect estimates) are based on analysis of crude/covariate-adjusted cluster-level summary (mean/proportion) female–male difference outcomes. Change in SBP is calculated as outcome at endpoint minus outcome at baseline.

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Enhanced hypertension care through private clinics in Pakistan: a cluster randomised trial
Muhammad Amir Khan, Nida Khan, John D Walley, Shaheer Ellahi Khan, Joseph Hicks, Faisal Imtiaz Sheikh, Muhammad Ahmar Khan, Muhammad Ali, Maqsood Ahmed, Haroon Jehangir Khan, Rony Zachariah
BJGP Open 2019; 3 (1): bjgpopen18X101617. DOI: 10.3399/bjgpopen18X101617

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Enhanced hypertension care through private clinics in Pakistan: a cluster randomised trial
Muhammad Amir Khan, Nida Khan, John D Walley, Shaheer Ellahi Khan, Joseph Hicks, Faisal Imtiaz Sheikh, Muhammad Ahmar Khan, Muhammad Ali, Maqsood Ahmed, Haroon Jehangir Khan, Rony Zachariah
BJGP Open 2019; 3 (1): bjgpopen18X101617. DOI: 10.3399/bjgpopen18X101617
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Keywords

  • Cluster randomised controlled trial
  • primary private clinics
  • hypertension
  • contextualised care package
  • primary care
  • General practice

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