major study variables
Answer Sheet:
Variables
List the major study variables, and categorize them as research variables or independent and dependent variables.
Discuss how well the variables reflect the concepts from the theory framework.
List the demographic variables measured in the study, and any extraneous variables identified by the authors. Evaluate whether or not there are missing demographic variables, in your opinion.
Research Design
Identify the specific study design. Explain whether the design was appropriate to answer the study’s research questions/ hypotheses.
Briefly describe the study procedures, including recruitment, screening for eligibility, consent, timing & method of measurement of demographic & key study variables, and intervention, if applicable.
Discuss the clarity of description of study procedures. In other words, could another researcher replicate the study using the procedures described in the article?
If more than one group was included in the study, explain how participants were assigned to groups.
Describe any threats to design validity mentioned by the authors. If they did not describe that, then say so.
Describe the limits of generalizability (external validity).
Population, Sample, & Setting
What was the population for the study?
Identify the specific sampling method used for the study. Discuss the adequacy of the sampling method for producing a sample representative of the population.
Discuss potential biases with the sampling method used.
Identify and evaluate the inclusion and exclusion criteria used in the study.
Discuss how the planned sample size was determined (including power analysis & consideration of potential attrition if included).
Discuss actual sample size attained for the study, including acceptance rate, refusal rate, and attrition rate.
Describe study setting and its appropriateness for the study.
Reference List
Effects of a Community Population Health Initiative on Blood Pressure Control in Latinos James R. Langabeer II, PhD, EdD; Timothy D. Henry, MD, FACC; Carlos Perez Aldana, MS; Larissa DeLuna; Nora Silva, MPA; Tiffany Champagne-Langabeer, PhD, RD
Background-—Hypertension remains one of the most important, modifiable cardiovascular risk factors. Yet, the largest minority ethnic group (Hispanics/Latinos) often have different health outcomes and behavior, making hypertension management more difficult. We explored the effects of an American Heart Association–sponsored population health intervention aimed at modifying behavior of Latinos living in Texas.
Methods and Results-—We enrolled 8071 patients, and 5714 (65.7%) completed the 90-day program (58.5 years �11.7; 59% female) from July 2016 to June 2018. Navigators identified patients with risk factors; initial and final blood pressure (BP) readings were performed in the physician’s office; and interim home measurements were recorded telephonically. The intervention incorporated home BP monitoring, fitness and nutritional counseling, and regular follow-up. Primary outcomes were change in systolic BP and health-related quality of life. Using a univariate paired-samples pre–post design, we found an average 5.5% (7.6- mm Hg) improvement in systolic BP (139.1 versus 131.5, t=10.32, P<0.001). Quality of life measured by the European quality of life 5-dimension visual analog scale improved from 0.79 to 0.82 (t=31.03, P56% Hispanic population). All patients were enrolled from 1 of 3 participating clinics in the University Health System, a county-owned academic medical center in San Antonio. Institutional review board approval was obtained from the University of Texas Health Science Center at Houston.
Intervention Nonclinical patient navigators provided patient screening, consent, education, coaching, and follow-up. Navigators are especially trained personnel who assist patients with the process of care and are especially useful for overcoming barriers and reducing disparities related to language or cultural gaps.19 Eligibility criteria included adult Latino patients with risk factors, including elevated, stage 1, or stage 2 hypertension (>120/80 mm Hg). To complete the program, the patient study duration required 90 consecutive days and a minimum of 3 interim measurements. The first and final BP readings were performed entirely in the clinic by the provider. During the interim, home BP measurements were obtained by navigators during follow-up phone calls with patients (about 30% of all measurements) or follow-up visits by the patients to the clinic.
Approximately 26% of the patients received BP cuffs through the program (SmartHeart automatic arm digital monitor; Veridian Healthcare). The remainder either were given prescriptions to purchase the same monitor or stated they had an existing digital arm cuff. All cuffs had to be for the arm, and wrist monitor measurements were not permitted. Patients were instructed to perform at least 2 repeated measurements and to record all readings on paper for subsequent follow-up with the navigator. Other specific instructions to reduce measurement errors were provided, including guidance on how to utilize monitoring devices, proper arm and sitting position, timing, inflation techniques, and the need for repeated measurements.20
During the office visit, brief (0.7, we did not find evidence of significant collinearity between any of the variables. Statistical significance was defined as P25), with a mean of 33.4 (considered obese class I). The mean intervention time for participants was 98.1 days.
Before study initiation, no participants were adhering to the AHA Life’s Simple 7 recommendations (including BP management, diet, BP, fitness, and activity). The majority (92.3%) were already placed on antihypertensive medication
before enrollment in the study and remained on medications during the intervention. Unless complications were reported in the interim, patients did not return to the physician’s office until the completion of the program; therefore, changes to medication were minimal. Only 110 patients (1.9%) had any change in dosage recorded during the program. Of those patients on medications, the majority had 1 primary medi- cation for hypertension management including calcium channel blocker in 30%, angiotensin-converting enzyme inhibitors in 60%, and angiotensin II receptor blockers in 10%. The results from interim measurements provided additional information for physicians to monitor medication concordance and improve BP management following the program’s completion. Table 1 summarizes the patient base- line characteristics.
There were minor differences in the demographics and baseline characteristics between those who did and did not complete the program, including higher rates of stroke, diabetes mellitus, prior heart failure, and baseline antihyper- tensive medications in patients who completed the program. Most patients dropped out of the program between the second and third BP readings. For compliant participants, we had full compliance for all readings during the program, largely because of proactive follow-up by the patient navigator.
There was a significant 5.5% improvement in mean SBP from 139.1 mm Hg at baseline to a final reading of 131.5 mm Hg (7.6 mm Hg, t=10.32, P<0.001). There was a similar 6% improvement in diastolic BP. Average EQ-5D score increased from 0.79 to 0.82 (t=31.03, P<0.001). Table 2
Table 1. Patient Characteristics
Variable Compliant Noncompliant P Value
Patients, n 5714 2357
Age, y, mean (SD) 58.5 (11.7) 57.14 (12.41) 0.001
Sex, female, n (%) 3353 (58.7) 1350 (57.3) 0.245
Body mass index, mean (SD) 33.4 (9.6) 33.7 (10.1) 0.112
Hispanic or Latino ethnicity, n (%)
4069 (71.2) 1697 (72.0) 0.010
Race, n (%)
White 4720 (82.6) 1968 (83.5) <0.001
Black 571 (10.0) 276 (11.7)
All others 423 (7.4) 113 (4.8)
Baseline characteristics, n (%)
Diabetes mellitus 3539 (61.9) 1335 (56.7) <0.001
Prior stroke 466 (8.1) 157 (6.6) <0.001
Prior heart failure 692 (12.1) 207 (8.7) <0.001
Antihypertensive medication 5277 (92.3) 2086 (88.6) <0.001
DOI: 10.1161/JAHA.118.010282 Journal of the American Heart Association 3
Community Hypertension Initiative for Latinos Langabeer et al O R IG
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nloaded from http://ahajournals.org by on January 7, 2020
summarizes the outcome differences between the initial and final readings for those who completed the program.
For patients who completed the intervention, there was a reduction in within-participant mean SBP at each reading across this consistent sample. The box plot in Figure shows trend reduction in participants’ SBP over 5 measurements during the 90-day period.
There was no significant difference between sexes for either outcome variable. With the dependent variable (im- provement in within-participant SBP) measured as a positive number, we fit a multivariate regression model. After control- ling for patient baseline and demographic factors, only BMI and change in QOL persisted as significant factors in SBP change in the final model (R2=0.092, P<0.001). Higher BMI and greater improvement in QOL were factors positively associated with improved SBP. Age, race, sex, ethnicity, medication compliance, and prior medical history were not significantly associated with reductions in SBP after controls. Table 3 shows the regression results.
Discussion We found that a targeted noninvasive intervention for Latinos, incorporating HBPM and lifestyle counseling, was associated with a reduction in mean SBP. We also observed an improvement in reported QOL scores during the program that were positively associated with SBP change. In addition, after controls for patient and demographic factors, individuals with greater BMI had the largest overall change. Cardiovas- cular health has been shown to have ethnic and racial variation, partially due to nutritional and cultural factors. Better understanding of the link between BMI and BP control is necessary,…
