Improved compliance measures: Applications in an ambulatory hypertensive drug trial

Rudd, Peter; Ahmed, Shaheda; Zachary, Valerie; Barton, Carol; Bonduelle, D.

doi:10.1038/clpt.1990.211

Cited by 131 publications

(60 citation statements)

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“…36 We chose to use MEMS caps as our primary measure of adherence because MEMS caps have a low failure rate 31 and may be more sensitive than other adherence measures. 37,38 In addition, prior studies have shown that MEMS caps do not signifi cantly infl uence adherence. 31,39 Also, any effect of MEMS caps on medication adherence would be experienced equally in both groups and, therefore, would not infl uence a comparative assessment by randomization assignment.…”

Section: Discussionmentioning

confidence: 99%

Integration of Depression and Hypertension Treatment: A Pilot, Randomized Controlled Trial

Bogner¹,

Vries²

2008

The Annals of Family Medicine

115

122

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PURPOSE We wanted to examine whether integrating depression treatment into care for hypertension improved adherence to antidepressant and antihypertensive medications, depression outcomes, and blood pressure control among older primary care patients. METHODSOlder adults prescribed pharmacotherapy for depression and hypertension from physicians at a large primary care practice in West Philadelphia were randomly assigned to an integrated care intervention or usual care. Outcomes were assessed at baseline, 2, 4, and 6 weeks using the Center for Epidemiologic Studies Depression Scale (CES-D) to assess depression, an electronic monitor to measure blood pressure, and the Medication Event Monitoring System to assess adherence. RESULTSIn all, 64 participants aged 50 to 80 years participated. Participants in the integrated care intervention had fewer depressive symptoms (CES-D mean scores, intervention 9.9 vs usual care 19.3; P <.01), lower systolic blood pressure (intervention 127.3 mm Hg vs usual care 141.3 mm Hg; P <.01), and lower diastolic blood pressure (intervention 75.8 mm Hg vs usual care 85.0 mm Hg; P <.01) compared with participants in the usual care group at 6 weeks. Compared with the usual care group, the proportion of participants in the intervention group who had 80% or greater adherence to an antidepressant medication (intervention 71.9% vs usual care 31.3%; P <.01) and to an antihypertensive medication (intervention 78.1% vs usual care 31.3%; P <.001) was greater at 6 weeks.CONCLUSION A pilot, randomized controlled trial integrating depression and hypertension treatment was successful in improving patient outcomes. Integrated interventions may be more feasible and effective in real-world practices, where there are competing demands for limited resources. Ann Fam Med 2008;6:295-301. DOI: 10.1370/afm.843. INTRODUCTIONP rimary care occupies a strategic position in the evaluation and treatment of depression among older adults, 1 and enhancing depression management in primary care appears to be a promising use of health care resources.2 To have an impact on public health, advances in the treatment of depression must be realized in primary care. Although recent studies have shown that a variety of primary care interventions can improve depression outcomes among older adults, 3,4 these interventions are not being widely implemented in practice. Some evidence indicates that addressing medical comorbidity, especially cardiovascular disease (CVD), may be essential in managing depression. [5][6][7] In addition, managing depression in the context of medical comorbidity may be more acceptable to patients than managing depression alone. DEPR ES SION A ND HY PER T ENSION T R E AT MEN Tmanagement of depression with management of medical comorbidity.In this trial, we focused on integrating depression management into care for hypertension. Hypertension affects between 20% to 50% of adults in most countries 9 and is a major risk factor for cardiovascular morbidity and mortality, 10 representing two-thirds of all s...

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Section: Discussionmentioning

confidence: 99%

Integration of Depression and Hypertension Treatment: A Pilot, Randomized Controlled Trial

Bogner¹,

Vries²

2008

The Annals of Family Medicine

115

122

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“…Prior to randomization, all eligible subjects received a single-blind, 30-day supply of placebo capsules and underwent a 4-week, single-blind run-in test (14,15) (Figure 1), which was designed to exclude from randomization subjects who were incapable of adhering (or unwilling to adhere) to a twice-daily dosing regimen and/or who could not/would not keep scheduled appointments. To "pass" the run-in test, subjects were required to keep 2 biweekly appointments (at week Ϫ2 and week 0) and to maintain Ն80% adherence to a twice-daily dosing regimen over the entire 4-week period (as indicated by the dates on/times at which each dose was taken) as recorded in the memory of an electronic dosing monitor (Medication Event Monitoring System; AARDEX, Union City, CA) contained in the cap of the medication vial (16,17). The requirements for the run-in test (and the consequences of failing) were disclosed to the subject prior to screening, at the time informed consent was obtained.…”

Section: Methodsmentioning

confidence: 99%

Effects of doxycycline on progression of osteoarthritis: Results of a randomized, placebo‐controlled, double‐blind trial

Brandt¹,

Mazzuca²,

Katz³

et al. 2005

Arthritis & Rheumatism

248

198

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Objective. To confirm preclinical data suggesting that doxycycline can slow the progression of osteoarthritis (OA). The primary outcome measure was joint space narrowing (JSN) in the medial tibiofemoral compartment.Methods. In this placebo-controlled trial, obese women (n ‫؍‬ 431) ages 45-64 years with unilateral radiographic knee OA were randomly assigned to receive 30 months of treatment with 100 mg doxycycline or placebo twice a day. Tibiofemoral JSN was measured manually in fluoroscopically standardized radiographic examinations performed at baseline, 16 months, and 30 months. Severity of joint pain was recorded at 6-month intervals.Results. Seventy-one percent of all randomized subjects completed the trial. Radiographs were obtained from 85% of all randomized subjects at 30 months. Adherence to the dosing regimen was 91.8% among subjects who completed the study per protocol. After 16 months of treatment, the mean ؎ SD loss of joint space width in the index knee in the doxycycline group was 40% less than that in the placebo group (0.15 ؎ 0.42 mm versus 0.24 ؎ 0.54 mm); after 30 months, it was 33% less (0.30 ؎ 0.60 mm versus 0.45 ؎ 0.70 mm). Doxycycline did not reduce the mean severity of joint pain, although pain scores in both treatment groups were low at baseline and remained low throughout the trial, suggesting the presence of a floor effect. However, the frequency of followup visits at which the subject reported a >20% increase in pain in the index knee, relative to the previous visit, was reduced among those receiving doxycycline. In contrast, doxycycline did not have an effect on either JSN or pain in the contralateral knee. In both treatment groups, subjects who reported a >20% increase in knee pain at the majority of their followup visits had more rapid JSN than those whose pain did not increase.Conclusion. Doxycycline slowed the rate of JSN in knees with established OA. Its lack of effect on JSN in the contralateral knee suggests that pathogenetic mechanisms in that joint were different from those in the index knee.In the present report, we describe the results of a randomized, placebo-controlled, double-blind trial of the tetracycline antibiotic, doxycycline, in subjects with knee osteoarthritis (OA). Selection of doxycycline as a potential disease-modifying OA drug was based not on the premise that OA is an infectious disease, but rather on results of in vitro studies showing 1) that doxycycline inhibited the degradation of type XI collagen, one of the minor collagens of articular cartilage, by 72-kd gelati-

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“…Devices for self-monitoring parameters such as symptoms, health status, blood pressure, anticoagulation, and blood glucose in the home environment are available, 45,46 yet these devices are not well integrated into treatment practice. Likewise, interactive technologies such as Web-based instruction and feedback that can support patient responses to these data are infrequently utilized.…”

Section: Study Novel Approaches To Enhance Patient Self-managementmentioning

confidence: 99%

Report of the National Heart, Lung, and Blood Institute Working Group on Outcomes Research in Cardiovascular Disease

et al. 2005

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Abstract-The National Heart, Lung, and Blood Institute convened a working group on outcomes research in cardiovascular disease (CVD). The working group sought to provide guidance on research priorities in outcomes research related to CVD. For the purposes of this document, "outcomes research" is defined as investigative endeavors that generate knowledge to improve clinical decision making and healthcare delivery to optimize patient outcomes. The working group identified the following priority areas: (1) national surveillance projects for high-prevalence CV conditions; (2) patient-centered care; (3) translation of the best science into clinical practice; and (4) studies that place the cost of interventions in the context of their real-world effectiveness. Within each of these topics, the working group described examples of initiatives that could serve the Institute and the public. In addition, the group identified the following areas that are important to the field: (1) promotion of the use of existing data; (2) O utcomes research is a field directed to the study and eventual improvement of the end results of health care. 1 "Outcomes research" can be defined as the study of the delivery and consequences of health care on outcomes from the perspective of patients, practitioners, and the healthcare system. Outcomes research focuses particularly on providing evidence to assess and promote the effectiveness of therapeutic interventions, enhancing the migration of best practice to clinical practice, improving decision making, elevating the quality of care, and supporting the optimal allocation of resources for all patients. Consequently, the research has a proximate and immediate connection to patient care and healthcare delivery.Despite the accelerating pace of basic and traditional clinical research in cardiovascular disease (CVD), there remains ample opportunity to improve clinical practice and healthcare delivery. Clinicians and policy makers often lack knowledge about gaps in healthcare delivery, disparities and inefficiencies, ineffectiveness of seemingly "proven" strategies, and the cumulative impact of interventions on the lives of patients. There is also a dearth of knowledge about how best to promote CV health and healthcare delivery in practice. 1-3 These gaps in knowledge hinder our ability to advance medical care even as our understanding of health and disease expands. We lack basic information about contemporary patterns of care and have a limited array of valid tools and strategies to quantify and improve clinical performance. We often demonstrate efficacy of treatments but commonly do not know the effectiveness of different clinical strategies in actual practice, as well as the impediments to achieving the true potential of the best interventions. We often do not know the impact of clinical and policy strategies on a broad range of patient outcomes, other than mortality and events. We lack basic information that would enhance clinical decision making from the patient's perspective. We lack evidence a...

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Improved compliance measures: Applications in an ambulatory hypertensive drug trial

Cited by 131 publications

References 0 publications

Integration of Depression and Hypertension Treatment: A Pilot, Randomized Controlled Trial

Integration of Depression and Hypertension Treatment: A Pilot, Randomized Controlled Trial

Effects of doxycycline on progression of osteoarthritis: Results of a randomized, placebo‐controlled, double‐blind trial

Report of the National Heart, Lung, and Blood Institute Working Group on Outcomes Research in Cardiovascular Disease

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