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Review ArticleClinical Review

Understanding the Quality Chasm for Hypertension Control in Diabetes: A Structured Review of “Co-maneuvers” Used in Clinical Trials

Aanand D. Naik, Tim T. Issac, Richard L. Street and Mark E. Kunik
The Journal of the American Board of Family Medicine September 2007, 20 (5) 469-478; DOI: https://doi.org/10.3122/jabfm.2007.05.070026
Aanand D. Naik
MD
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Tim T. Issac
MD
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Richard L. Street Jr
PhD
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Mark E. Kunik
MD, MPH
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    Figure 1.

    The role of collaborative goal setting and action planning to improve the effectiveness of treatment for hypertension control.

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    Table 1.

    Baseline Characteristics of Included Trials

    Clinical TrialPrincipal ManeuverComparison ManeuverStudy DesignEligibility CriteriaEnrollment ProceduresPrimary Outcome
    1. SHEP (Systolic Hypertension in Elderly) subgroup18ChlorthalidonePlacebo + Usual CareDBAge ≥60 years, NIDDM, BP ≥ 160/90IC, RCStroke
    2. SYST-EUR (Systolic Hypertension in Europe Trial) subgroup19NitrendipinePlacebo + Usual CareDBAge ≥60 years, SBP ≥ 160, controlled DMIC, RCStroke
    3. ALLHAT (Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attacks Trial) subgroup20,21ChlorthalidoneLisinopril, AmlodipineDBAge ≥55 years, DM, HTN + CV RFsIC, RCComposite CV endpoints
    4. CAPPP (Captopril Prevention Project) subgroup22CaptoprilUsual CareO-BEAge 25 to 65 years, DM + DBP >100IC, RCComposite CV endpoints
    5. LIFE (Losartan Intervention for Endpoint Reduction in Hypertension Study) subgroup23LosartanAtenololDBAge 55 to 80 years, DM, HTN + LVHIC, RCComposite CV endpoints
    6. STOP-2 (Swedish Trial in Old Patients with Hypertension) subgroup24Calcium antagonists, ACE inhibitorsUsual CareO-BEAge 70 to 84 years, DM + HTNIC, RCComposite CV endpoints
    7. INSIGHT (International Nifedipine GITS Study) subgroup25Nifedipine GITSDiureticsDBAge 55 to 80 years, DM, HTN + CV RFsIC, RCComposite CV endpoints
    8. JMIC-B (Japan Multicenter Investigation for Cardiovascular Diseases) subgroup26NifedipineACE inhibitorO-BEAge 55 to 75 years, DM, HTN + CADIC, RCComposite CV endpoints
    9. IDNT (Irbesartan Diabetic Nephropathy Trial)27IrbesartanAmlodipine + usual careDBAge 30 to 70 years, DM, HTN + albuminuriaIC, RCComposite CV endpoints
    10. CONVINCE (Controlled Onset Verapamil Investigation of Cardiovascular Endpoints) subgroup28VerapamilUsual careDBAge ≥55 years, DM + HTNIC, RCComposite CV endpoints
    11. BENEDICT (Bergamo Nephrologic Diabetes Complications Trial)29TrandolaprilVerapamil + placeboDBAge >40 years, DM, HTN + no micoalbuminuriaIC, RC,TPPMicroalbuminuria
    12. INVEST (International Verapamil SR-trandolapril Study) subgroup30VerapamilAtenololO-BEAge >70 years, DM, HTN + CADIC, RC,TPPComposite CV endpoints
    13. FACET (Fosinopril versus Ampldipine Cardiovascular Events Randomized Trial) subgroup31FosinoprilAmlodipine + usual careO-BEAge >60 years, DM + BP≥140/90IC, RC,TPPComposite CV endpoints
    14. NORDIL (Nordic Diltiazam Study) subgroup32DiltiazamUsual careO-BEAge 50 to 80 years, DM + DBP >100IC, RCComposite CV endpoints
    15. Hypertension in Diabetes Study IV33Tight BP controlLess tight BP controlOPAge 25 to 65 years, DM, BP ≥ 150/85IC, RCMacro/Micro Vascular Complications
    16. UKPDS (United Kingdom Prospective Diabetes Study) subgroup34Tight BP controlLess tight BP controlOPAge 25 to 65 years, DM + HTNIC, RCDeath
    17. HOT (Hypertension Optimal Treatment Study) subgroup35Tight BP controlLess tight BP controlO-BEAge 50 to 80 years, DM + DBP > 100IC, RCComposite CV endpoints
    18. ABCD (Appropriate Blood Pressure Control in Diabetes Trial)36Tight BP controlLess tight BP controlOPAge 40 to 75 years, DM + untreated DBP > 80IC, RCDiabetic nephropathy
    19. Steno-2 Study37Intensive multi-risk factor controlConventional strategiesOPDM + microalbuminuriaIC, RC,TPPMacro- or microvascular complications
    20. High Risk Patients with Diabetes: A Motivation and Teaching Intervention38Personalized BP goalsUsual careOPAge 45 to 70 years, DM + BP > 140/90IC, RC,TPPMicrovascular complications
    • ACE, angiotensin-converting enzyme; BP, blood pressure; DB, double blinded; O-BE, open, blinded to endpoints; OP, open pragmatic; DM, diabetes mellitus; HTN, hypertension; SBP, systolic blood pressure; DBP, diastolic blood pressure; CV, cardiovascular; RF, risk factors; IC, informed consent; RC, reviewed medical charts; TPP, targeted physician practices.

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    Table 2.

    Co-Maneuvers Used in Randomized Controlled Trials

    Co-maneuver TypesCo-maneuver Characteristics by Study (Indicated by Reference Number)
    Frequency of clinic visitsFrequent baseline visits:18, 22–31, 35, 36, 38Every 3 to 4 months: 18–20, 25, 27, 29, 33, 34, 37Every 6 months: 22–24, 26, 28, 30–32, 35, 36Annual follow-up only: 38
    Activities occurring at each visitTreatment titrated unless BP at target: 18–37BP measured and compared to target: 18–38Assessment of study endpoints: 18–38
    Feedback given to study cliniciansDetailed feedback and decision support: 38Structured reminders of participants’ status: 20, 30, 33, 34No additional structured decision support: 18, 19, 22–28, 32, 35–37
    Education offered to study participantsCounseling, support, and behavior modification education: 37, 38Structured education at follow-up visits: 18, 21No structured education: 19, 22–36
    Specificity of blood pressure target(s)A specific systolic and/or diastolic BP target: 18, 20–38Targeted BP change from baseline: 19, 25, 27, 31
    Action plan for modification of treatmentsAction plan explicitly defined: 18–37Specific medications or medication classes: 18–38
    Communication of adverse events from principal maneuverAdverse events discussed at each follow-up: 18–37Specific adverse events queried: 19, 20–27, 29, 30, 32–37No published documentation of adverse events: 38
    • BP, blood pressure.

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The Journal of the American Board of Family Medicine: 20 (5)
The Journal of the American Board of Family Medicine
Vol. 20, Issue 5
September-October 2007
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Understanding the Quality Chasm for Hypertension Control in Diabetes: A Structured Review of “Co-maneuvers” Used in Clinical Trials
Aanand D. Naik, Tim T. Issac, Richard L. Street, Mark E. Kunik
The Journal of the American Board of Family Medicine Sep 2007, 20 (5) 469-478; DOI: 10.3122/jabfm.2007.05.070026

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Understanding the Quality Chasm for Hypertension Control in Diabetes: A Structured Review of “Co-maneuvers” Used in Clinical Trials
Aanand D. Naik, Tim T. Issac, Richard L. Street, Mark E. Kunik
The Journal of the American Board of Family Medicine Sep 2007, 20 (5) 469-478; DOI: 10.3122/jabfm.2007.05.070026
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