Refusal to participate in heart failure studies: do age and gender matter?

Abstract

Aims and objectives The objective of this retrospective study was to evaluate reasons heart failure patients decline study participation, to inform interventions to improve enrollment. Background Failure to enrol older heart failure patients (age > 65) and women in studies may lead to sampling bias, threatening study validity. Design This study was a retrospective analysis of refusal data from four heart failure studies that enrolled 788 patients in four states. Methods Chi-Square and a pooled t-test were computed to analyse refusal data (n = 300) obtained from heart failure patients who were invited to participate in one of the four studies but declined. Results Refusal reasons from 300 patients (66% men, mean age 65 33) included: not interested (n = 163), too busy (n = 64), travel burden (n = 50), too sick (n = 38), family problems (n = 14), too much commitment (n = 13) and privacy concerns (n = 4). Chi-Square analyses showed no differences in frequency of reasons (p > 0 05) between men and women. Patients who refused were older, on average, than study participants. Conclusions Some reasons were patient-dependent; others were study-dependent. With ‘not interested’ as the most common reason, cited by over 50% of patients who declined, recruitment measures should be targeted at stimulating patients’ interest. Additional efforts may be needed to recruit older participants. However, reasons for refusal were consistent regardless of gender. Relevance to clinical practice Heart failure researchers should proactively approach a greater proportion of women and patients over age 65. With no gender differences in type of reasons for refusal, similar recruitment strategies can be used for men and women. However, enrolment of a representative proportion of women in heart failure studies has proven elusive and may require significant effort from researchers. Employing strategies to stimulate interest in studies is essential for recruiting heart failure patients, who overwhelmingly cited lack of interest as the top reason for refusal.

Who says “no” to participating in stroke clinical trials and why: an observational study from the Vancouver Stroke Program

“…This discomfort with randomization has been confirmed in previous surgical intervention studies [11]. Consistent with other work [1, 12], our analysis found that disinterest was a common reason for participation refusal, particularly in the device study. Previous work investigating home health monitoring devices suggests that patients often have no interest in using a device or they perceive it as unnecessary [13].…”

Health effectiveness of community health workers as a diabetes self-management intervention

“…Although according to the CDC, 45 there is a minimal difference in diabetes rates among men (6.6%) and women (5.9%), studies show that reasons for refusing to participate in studies is the same among men and women. [46][47][48] Participants of this study were recruited, engaged and retained; there was an 84.4% retention rate for the entire 12 months of the study, with only 15.6% lost to follow-up. Retention rates were similar in the IG and CG groups (90% and 88%, respectively) and slightly lower in the ACG group (75%; Table 2).…”

A research tool for measuring non-participation of older people in research on digital health

“…Research participants are likely to be younger than those who decline to participate [6, 26, 37–41]. Decliners have also been found to have lower levels of education [7, 41, 42] and lower QOL [42], worse health [37, 38, 41, 43–45], more cognitive impairment [45] and higher levels of perceived social support [41] compared to participants. The role of gender is less clear.…”

“…The role of gender is less clear. Some studies show that men are more likely than women to participate in health-related research [7, 26, 39, 40], while others demonstrate the opposite [46] or no [38] effect. Lack of time and competing tasks have been described as further reasons for declining participation in health-related research [33, 38, 47–49], and in some cases the lack of time was due to care-related activities [37].…”

“…Some studies show that men are more likely than women to participate in health-related research [7, 26, 39, 40], while others demonstrate the opposite [46] or no [38] effect. Lack of time and competing tasks have been described as further reasons for declining participation in health-related research [33, 38, 47–49], and in some cases the lack of time was due to care-related activities [37]. Participants, on the other hand, participated in the research because they hoped to improve their health and benefit from more care and support [50], and to contribute to science and society [50, 51].…”