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

Jordan M. Harrison; Miyeon Jung; Terry A. Lennie; Debra K. Moser; Dean G. Smith; Sandra B. Dunbar; David L. Ronis; Todd M. Koelling; Bruno Giordani; Penny L. Riley; Susan J. Pressler

doi:10.1111/jocn.13135

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

Jordan M. Harrison, Miyeon Jung, Terry A. Lennie, Debra K. Moser, Dean G. Smith, Sandra B. Dunbar, David L. Ronis, Todd M. Koelling, Bruno Giordani, Penny L. Riley, Susan J. Pressler

College of Nursing

Research output: Contribution to journal › Article › peer-review

20 Scopus citations

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.

Original language	English
Pages (from-to)	983-991
Number of pages	9
Journal	Journal of Clinical Nursing
Volume	25
Issue number	7-8
DOIs	https://doi.org/10.1111/jocn.13135
State	Published - Apr 1 2016

Bibliographical note

Publisher Copyright:
© 2016 John Wiley & Sons Ltd.

Funding

The BMI study (Lennie et al. 2011) was supported in part by a grant from NIH NINR R01 NR009280; General Clinical Research Centers at University of Kentucky: M01RR02602; Emory University: M01RR0039; PHS Grant UL1 RR025008 from the Clinical and Translational Science Award program, National Center for Research Resources, and the Atlanta Veterans Administration Medical Center; Indiana University: MO1 RR000750; and NIH, NINR Center grant 1P20NR010679 to the University of Kentucky College of Nursing. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NINR, NCRR or the Veterans Administration. The THINK study (Pressler et al. 2008) was funded by the NINR (R01 NR008147). The MEMOIR study (Pressler et al. 2011) was funded by NINR research grants R01 NR008147 and P30 NR009000. MEMOIR-2 (Pressler 2014, epub ahead of print) was funded by MCubed Project of the University of Michigan and supported in part by the Michigan Institute for Clinical Research (2UL1TR000433). For both MEMOIR studies, Brain Fitness software was donated by PositScience and Heart Insight magazines were donated by the American Heart Association.

Funders	Funder number
Atlanta Veterans Administration Medical Center
Michigan Institute for Clinical and Health Research	2UL1TR000433
NIH NINR	R01 NR009280
NINR Center	1P20NR010679
University of Kentucky College of Nursing, 533 College of Nursing Building
National Institutes of Health (NIH)
National Institute of Health National Institute of Nursing Research
National Center for Research Resources
U.S. Department of Veterans Affairs	P30 NR009000, R01 NR008147
U.S. Department of Veterans Affairs
American the American Heart Association
National Center for Advancing Translational Sciences (NCATS)	UL1TR002378
National Center for Advancing Translational Sciences (NCATS)
University of Southern Indiana	MO1 RR000750
University of Southern Indiana
Michigan Retirement Research Center, University of Michigan
University of Kentucky	M01RR0039, M01RR02602, UL1 RR025008
University of Kentucky

Keywords

Cardiovascular
Heart disease
Older
Research
Women

ASJC Scopus subject areas

General Nursing

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10.1111/jocn.13135

Cite this

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title = "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.",

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author = "Harrison, \{Jordan M.\} and Miyeon Jung and Lennie, \{Terry A.\} and Moser, \{Debra K.\} and Smith, \{Dean G.\} and Dunbar, \{Sandra B.\} and Ronis, \{David L.\} and Koelling, \{Todd M.\} and Bruno Giordani and Riley, \{Penny L.\} and Pressler, \{Susan J.\}",

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AU - Lennie, Terry A.

AU - Moser, Debra K.

AU - Smith, Dean G.

AU - Dunbar, Sandra B.

AU - Ronis, David L.

AU - Koelling, Todd M.

AU - Giordani, Bruno

AU - Riley, Penny L.

AU - Pressler, Susan J.

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

Abstract

Bibliographical note

Funding

Keywords

ASJC Scopus subject areas

Access to Document

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