Representation of Patients With Chronic Kidney Disease in Clinical Trials of Cardiovascular Disease Medications: A Systematic Review.

Importance: Patients with chronic kidney disease (CKD) are at high risk for cardiovascular disease, but their systematic underrepresentation in cardiovascular randomized clinical trials (RCTs) limits the generation of appropriate evidence to guide cardiovascular risk management (CVRM). Objective: To evaluate the underrepresentation of patients with CKD in cardiovascular RCTs, and to highlight evidence gaps in CVRM medications in this population. Evidence Review: A systematic search was conducted in ClinicalTrials.gov from February 2000 through October 2021 for RCTs with full-text publications. If no full-text publications were found in ClinicalTrials.gov, MEDLINE, Embase, and Google Scholar were also searched. Eligible RCTs were those evaluating the effectiveness of antiplatelets, anticoagulants, blood pressure-lowering drugs, glucose-lowering drugs, or cholesterol-lowering drugs in adults with cardiovascular disease or cardiovascular risk factors. Trials with a sample size of fewer than 100 patients were excluded. Findings: In total, 1194 RCTs involving 2 207 677 participants (mean [SD] age, 63 [6] years; 1 343 970 males [64%]) were included. Since 2000, the percentage of cardiovascular RCTs excluding patients with CKD has increased from 66% to 79% (74% overall [884 RCTs]). In 864 RCTs (72%), more patients were excluded than anticipated on safety grounds (63% [306] of trials required no dose adjustment, and 79% [561] required dose adjustment). In total, 158 RCTs (13%) reported results for patients with CKD separately (eg, in subgroup analyses). Significant evidence gaps exist in most CVRM interventions for patients with CKD, particularly for those with CKD stages 4 to 5. Twenty-three RCTs (2%) reported results for patients with an estimated glomerular filtration rate less than 30 mL/min/1.73 m2, 15 RCTs (1%) reported for patients receiving dialysis, and 1 RCT (0.1%) reported for recipients of kidney transplant. Conclusions and Relevance: Results of this systematic review suggest that representation of patients with CKD in cardiovascular RCTs has not improved in the past 2 decades and that these RCTs excluded more patients with CKD than expected on safety grounds. Lack of reporting or underreporting of results for this patient population is associated with evidence gaps in the effectiveness of most CVRM medications in patients with all stages of CKD, particularly CKD stages 4 to 5.

Patients' Experiences, Needs, and Expectations of Cooperation Between Medical Specialists and Occupational Health Physicians: A Qualitative Study.

OBJECTIVE: Cooperation between clinical and occupational health care practitioners is a key aspect of clinical work-integrating care. This study aimed to gain insight into patients' experiences, needs, and expectations regarding cooperation between medical specialists and occupational health physicians. METHODS: A thematic qualitative study was conducted involving a total of 33 participants in eight online focus groups. RESULTS: Participants indicated practitioners are currently working in an isolated manner. However, participants desired for partnership between specialists and occupational health physicians to address work-related concerns and showed a need for explanation of the consequences of their diagnosis, so this can be translated into their ability to work. CONCLUSIONS: Currently, cooperation between clinical and occupational health care is lacking. Yet, some participants experienced that these disciplines could complement each other by working together to support patients in work participation.

Current practices, needs, and expectations of discussing work with a medical specialist from a patient's perspective: a qualitative study.

PURPOSE: Attention to paid work in clinical health care-clinical work-integrating care (CWIC)-might be beneficial for patients of working age. However, the perceptions and expectations of patients about CWIC are unknown. The aim of this study was to develop an understanding of current practices, needs, and expectations among patients for discussing work with a medical specialist. MATERIALS AND METHODS: A qualitative study was undertaken involving patients with diverse medical conditions (n = 33). Eight online synchronous focus groups were held. A thematic analysis was then performed. RESULTS: Three themes emerged from the data: (1) the process of becoming a patient while wanting to work again, (2) different needs for different patients, (3) patients' expectations of CWIC. We identified three different overarching categories of work-concerns: (a) the impact of work on disease, (b) the impact of disease or treatment on work ability, and (c) concerns when work ability remained decreased. For each category of concerns, patients expected medical specialists to perform differing roles. CONCLUSIONS: Patients indicated that they need support for work-related concerns from their medical specialists and/or other professionals. Currently, not all work concerns received the requested attention, leaving a portion of the patients with unmet needs regarding CWIC.

Patients have a wide range of questions regarding work and health, which they want to discuss with their medical specialistIn current clinical practice, not all work concerns get the requested attention, leaving some patients with unmet needsCooperation with different health care professionals, including rehabilitation occupational health care, might aid in supporting patients with their work-related questions.