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Randomized Controlled Trial

. 2017 Aug 24;377(8):733-744.

doi: x.1056/NEJMoa1611179.

Issue of Intensive Claret-Pressure level Treatment on Patient-Reported Outcomes

Capri G Foy 1 , Lewis E Kazis 1 , Linda P Bolin one , Molly B Conroy 1 , Peter Fitzpatrick 1 , Tanya R Gure ane , Paul 50 Kimmel i , Kent Kirchner 1 , Donald Due east Morisky 1 , Jill Newman 1 , Christine Olney 1 , Suzanne Oparil 1 , Nicholas 1000 Pajewski 1 , James Powell i , Thomas Ramsey 1 , Debra L Simmons 1 , Joni Snyder i , Marking A Supiano 1 , Daniel E Weiner i , Jeff Whittle one , Sprint Research Group

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  • PMID: 28834483
  • PMCID: PMC5706112
  • DOI: 10.1056/NEJMoa1611179

Free PMC article

Randomized Controlled Trial

Issue of Intensive Blood-Force per unit area Handling on Patient-Reported Outcomes

Dan R Berlowitz  et al. N Engl J Med. .

Complimentary PMC commodity

Abstract

Groundwork: The previously published results of the Systolic Blood Pressure Intervention Trial showed that among participants with hypertension and an increased cardiovascular risk, simply without diabetes, the rates of cardiovascular events were lower among those who were assigned to a target systolic blood pressure level of less than 120 mm Hg (intensive treatment) than amid those who were assigned to a target of less than 140 mm Hg (standard treatment). Whether such intensive treatment affected patient-reported outcomes was uncertain; those results from the trial are reported here.

Methods: Nosotros randomly assigned 9361 participants with hypertension to a systolic blood-pressure target of less than 120 mm Hg or a target of less than 140 mm Hg. Patient-reported issue measures included the scores on the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the Veterans RAND 12-Item Health Survey, the Patient Health Questionnaire 9-item depression scale (PHQ-9), patient-reported satisfaction with their blood-pressure care and blood-pressure medications, and adherence to blood-pressure medications. We compared the scores in the intensive-treatment group with those in the standard-treatment grouping among all participants and among participants stratified according to physical and cognitive part.

Results: Participants who received intensive treatment received an boilerplate of one additional antihypertensive medication, and the systolic blood pressure was fourteen.8 mm Hg (95% confidence interval, 14.3 to 15.4) lower in the group that received intensive handling than in the grouping that received standard treatment. Hateful PCS, MCS, and PHQ-9 scores were relatively stable over a median of 3 years of follow-upward, with no meaning differences betwixt the two handling groups. No significant differences between the handling groups were noted when participants were stratified according to baseline measures of physical or cognitive office. Satisfaction with blood-pressure care was high in both handling groups, and nosotros constitute no significant difference in adherence to blood-pressure level medications.

Conclusions: Patient-reported outcomes amid participants who received intensive treatment, which targeted a systolic blood pressure of less than 120 mm Hg, were similar to those amidst participants who received standard treatment, including amid participants with decreased physical or cerebral function. (Funded past the National Institutes of Health; Dart ClinicalTrials.gov number, NCT01206062 .).

Figures

Figure 1
Effigy ane. Patient-Reported Outcomes in the Two Treatment Groups over Fourth dimension

The data points correspond the estimated hateful based on a linear mixed model; I bars denote 95% confidence intervals. The values below each graph indicate the number of participants assessed at each trial visit. Scores on the Concrete Component Summary (PCS) and Mental Component Summary (MCS) of the Veterans RAND 12-Item Wellness Survey (VR-12) are standardized with a hateful of 50 and a standard departure of x; scores range from 0 to 100, with higher scores denoting meliorate physical health and mental health, respectively. Scores on the Patient Health Questionnaire nine-detail depression calibration (PHQ-ix) range from 0 to 27, with college scores indicating greater severity of depressive symptoms and scores of 10 or college suggesting moderate-to-severe depressive symptoms.

Figure 2
Effigy 2. Scores on the VR-12 over Time, According to Treatment Grouping and Number of Medical Coexisting Conditions

The burden of medical coexisting conditions was categorized as two or fewer, 3 or iv, 5 or six, or vii or more than. The data points stand for the estimated mean based on a linear mixed model, with I bars denoting 95% confidence intervals. The values below each graph indicate the number of participants assessed at each trial visit, co-ordinate to the number of circumstantial conditions participants had at baseline. Coexisting conditions were reported past the participants with the apply of the Selim comorbidity index, which assesses xxx medical weather and 6 mental health weather condition. The physical score on the Selim comorbidity index was calculated as the sum of the number of these thirty possible medical conditions reported, and the mental score was the sum of the number of these six possible mental health conditions reported.

Figure 3
Figure 3. Scores on the VR-12 over Time, According to Treatment Group and Historic period Category

The data points represent the estimated mean based on a linear mixed model, with I bars denoting 95% conviction intervals. The values below each graph indicate the number of participants assessed at each trial visit, co-ordinate to historic period category.

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