Implementation of a consent for chart review and contact and its impact in one clinical centre

Druce, Irena; Ooi, Teik Chye; McGuire, Debbie; Sorisky, Alexander; Malcolm, Janine

doi:10.1136/medethics-2013-101765

Cited by 5 publications

(3 citation statements)

References 7 publications

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“…Several studies have documented the implementation of registries which utilise this recruitment method [ 23 – 26 ]. Studies have demonstrated it to be cost efficient [ 24 , 25 ], accelerate patient involvement in research [ 23 , 24 ], have high consent rates [ 23 , 25 , 26 ] and to improve consumer autonomy by reducing the role of the clinician as a ‘gatekeeper’ [ 23 ]. With this method demonstrating such promising results, there is an urgent need to continue this research through the consideration of consumer preferences for research participation, such as frequency of participation and methods of contact.…”

Section: Introductionmentioning

confidence: 99%

A consumer register: an acceptable and cost-effective alternative for accessing patient populations

Bryant

Sanson‐Fisher

Fradgley

et al. 2016

BMC Med Res Methodol

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BackgroundPopulation-based registries are increasingly used to recruit patient samples for research, however, they have several limitations including low consent and participation rates, and potential selection bias. To improve access to samples for research, the utility of a new model of recruitment termed the ‘Consumer Register’, that allows for direct patient recruitment from hospitals, was examined. This paper reports: (i) consent rates onto the register; (ii) preferred methods and frequency of contact; and (iii) the feasibility of establishing the register, including: (a) cost per person recruited to the register; (b) the differential cost and consent rates of volunteer versus paid data collectors; and (c) participant completion rates.MethodsA cross-sectional survey was conducted in five outpatient clinics in Australia. Patients were approached by volunteers or paid data collectors and asked to complete a touch-screen electronic survey. Consenting individuals were asked to indicate their willingness and preferences for enrolment onto a research register. Descriptive statistics were used to examine patient preferences and linear regression used to model the success of volunteer versus paid data collectors. The opportunity and financial costs of establishing the register were calculated.ResultsA total of 1947 patients (80.6 %) consented to complete the survey, of which, 1486 (76.3 %) completed the questionnaire. Of the completers, the majority (69.4 %, or 1032 participants) were willing to be listed on the register and preferred to be contacted by email (50.3 %). Almost 39 % of completers were willing to be contacted three or more times in a 12 month period. The annual opportunity cost of resources consumed by the register was valued at $37,187, giving an opportunity cost per person recruited to the register of $36. After amortising fixed costs, the annual financial outlay was $23,004 or $22 per person recruited to the register. Use of volunteer data collectors contributed to an annual saving of $14,183, however paid data collectors achieved significantly higher consent rates. Successful enrolment onto the register was completed for 42 % of the sample.ConclusionsA Consumer Register is a promising and feasible alternative to population-based registries, with the majority of participants willing to be contacted multiple times via low-resource methods such as email. There is an effectiveness/cost trade off in the use of paid versus volunteer data collectors.

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Section: Introductionmentioning

confidence: 99%

A consumer register: an acceptable and cost-effective alternative for accessing patient populations

Bryant

Sanson‐Fisher

Fradgley

et al. 2016

BMC Med Res Methodol

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“…32 Others have suggested that while uptake to specific research may increase among those giving permission to contact (compared to those recruited through traditional physician-mediated contacts), there may be significant differences in the age and gender of those who agreed compared to those who declined the permission to contact form. 33 A further consideration is whether a permission to contact agreement constitutes a valid consent. Studies indicate that there may be confusion among patients as to whether they were immediately signing up to research, 34 and this may be especially true when patients are recruited upon arrival to the hospital prior to diagnosis.…”

Section: Countervailing Trendsmentioning

confidence: 99%

Is the Red Queen Sitting on the Throne?

Nicholls¹

2021

The Cambridge Handbook of Health Research Regulation

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Human health research is a vast enterprise; worldwide, hundreds of billions of dollars are spent annually on health research involving millions of research participants. 1 This research is guided by multiple regulations and guidance documents that commonly reflect several core principles: the protection of the rights and welfare of individual research participants; the promotion of justice in the practice and outcomes of research; and that human health research should be socially valuable (see van Delden and van der Graff , Chapter 4, in this volume). In addition, oftcited goals of health research regulation include the development of a culture of ethical concern among researchers and institutions, and the maintenance of public trust in the research enterprise. 2 However, these generally accepted principles belie an ongoing tension between the protection of individual participants through appropriate regulation, and the facilitation of health research. 3 Authors have, for example, written regarding the amount of waste in research, including inefficient research regulation and management. 4 Others have pointed to the variation in decisions 5 and time takenwith associated costs 6of obtaining ethics

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“…There are several models for sign-up, including allowing patients to sign up on their own at home, on their own in the clinic at a kiosk, or with help from staff at a clinic appointment. Available data suggest that patient registries are cost-effective [13,14], increase patient involvement in research [12,14] have high consent rates [13,19], and improve patient autonomy [12]. For example, data from Rimel et al suggest that online registries can boost participation by more than 4 times compared with paper registries, with higher participation from minorities [20].…”

Section: Journal Of Clinical and Translational Sciencementioning

confidence: 99%

Evaluation of 3 approaches for increasing patient engagement in clinical research: Feedback from a community engagement advisory board

Matthews

Rak

Anderson

et al. 2018

J. Clin. Trans. Sci.

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IntroductionThe purpose of this study was to obtain feedback from a diverse group of community advisory board members about different clinic or hospital-based approaches to increasing research participation.MethodsMembers of an established community engagement advisory board (n=16) provided qualitative and survey data regarding attitudes and preferences for 3 hospital and clinic system strategies to recruit patients into clinical research including universal consent for research, patient registries, and patient portals.ResultsOverall, there was moderate support for each of the 3 approaches discussed. Board members described advantages and disadvantages of each method. Based on the qualitative data, universal consent was viewed as the best strategy for consenting high volumes of patients for research. However, patient registries and portals were seen as more acceptable, less-intrusive and more likely to result in higher participation rates. Survey data were consistent with qualitative findings.ConclusionsInput from community stakeholders is needed to identify strategies to enhance participation and increase diversity in clinical research. Members of our CEAB identified patient registries and portals as feasible and nonintrusive approaches to increasing research participation. Additional research is needed to confirm these findings and to establish best practices for supporting patients in using registry approaches.

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Implementation of a consent for chart review and contact and its impact in one clinical centre

Abstract: Consent for chart review and contact addresses several important ethical issues regarding the use of patient clinical information for research purposes. Our study demonstrated how such a process can be implemented.

Cited by 5 publications

References 7 publications

A consumer register: an acceptable and cost-effective alternative for accessing patient populations

A consumer register: an acceptable and cost-effective alternative for accessing patient populations

Is the Red Queen Sitting on the Throne?

Evaluation of 3 approaches for increasing patient engagement in clinical research: Feedback from a community engagement advisory board

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