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Practical application of opt-out recruitment methods in two health services research studies.

ABSTRACT: BACKGROUND:Participant recruitment is an ongoing challenge in health research. Recruitment may be especially difficult for studies of access to health care because, even among those who are in care, people using services least often also may be hardest to contact and recruit. Opt-out recruitment methods (in which potential participants are given the opportunity to decline further contact about the study (opt out) following an initial mailing, and are then contacted directly if they have not opted out within a specified period) can be used for such studies. However, there is a dearth of literature on the effort needed for effective opt-out recruitment. METHODS:In this paper we describe opt-out recruitment procedures for two studies on access to health care within the U.S. Department of Veterans Affairs. We report resource requirements for recruitment efforts (number of opt-out packets mailed and number of phone calls made). We also compare the characteristics of study participants to potential participants via t-tests, Fisher's exact tests, and chi-squared tests. RESULTS:Recruitment rates for our two studies were 12 and 21%, respectively. Across multiple study sites, we had to send between 4.3 and 9.2 opt-out packets to recruit one participant. The number of phone calls required to arrive at a final status for each potentially eligible Veteran (i.e. study participation or the termination of recruitment efforts) were 2.9 and 6.1 in the two studies, respectively. Study participants differed as expected from the population of potentially eligible Veterans based on planned oversampling of certain subpopulations. The final samples of participants did not differ statistically from those who were mailed opt-out packets, with one exception: in one of our two studies, participants had higher rates of mental health service use in the past year than did those mailed opt-out packets (64 vs. 47%). CONCLUSIONS:Our results emphasize the practicality of using opt-out methods for studies of access to health care. Despite the benefits of these methods, opt-out alone may be insufficient to eliminate non-response bias on key variables. Researchers will need to balance considerations of sample representativeness and feasibility when designing studies investigating access to care.

SUBMITTER: Miller CJ

PROVIDER: S-EPMC5391553 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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Practical application of opt-out recruitment methods in two health services research studies.

Miller Christopher J CJ Burgess James F JF Fischer Ellen P EP Hodges Deborah J DJ Belanger Lindsay K LK Lipschitz Jessica M JM Easley Siena R SR Koenig Christopher J CJ Stanley Regina L RL Pyne Jeffrey M JM

BMC medical research methodology 20170414 1

<h4>Background</h4>Participant recruitment is an ongoing challenge in health research. Recruitment may be especially difficult for studies of access to health care because, even among those who are in care, people using services least often also may be hardest to contact and recruit. Opt-out recruitment methods (in which potential participants are given the opportunity to decline further contact about the study (opt out) following an initial mailing, and are then contacted directly if they have ...[more]

PMID: 28410585

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Project description:Due to recently proposed changes in the Common Rule regarding the collection of research preferences, there is an increased need for efficient methods to document opt-in research preferences at a population level. Previously, our institution developed an opt-out paper-based workflow that could not be utilized for research in a scalable fashion. This project was designed to demonstrate the feasibility of implementing an electronic health record (EHR)-based active opt-in research preferences program. The first phase of implementation required creating and disseminating a patient questionnaire through the EHR portal to populate discreet fields within the EHR indicating patients' preferences for future research study contact (contact) and their willingness to allow anonymised use of excess tissue and fluid specimens (biobank). In the second phase, the questionnaire was presented within a clinic nurse intake workflow in an obstetrical clinic. These permissions were tabulated in registries for use by investigators for feasibility studies and recruitment. The registry was also used for research patient contact management using a new EHR encounter type to differentiate research from clinical encounters. The research permissions questionnaire was sent to 59,670 patients via the EHR portal. Within four months, 21,814 responses (75% willing to participate in biobanking, and 72% willing to be contacted for future research) were received. Each response was recorded within a patient portal encounter to enable longitudinal analysis of responses. We obtained a significantly lower positive response from the 264 females who completed the questionnaire in the obstetrical clinic (55% volunteers for biobank and 52% for contact). We demonstrate that it is possible to establish a research permissions registry using the EHR portal and clinic-based workflows. This patient-centric, population-based, opt-in approach documents preferences in the EHR, allowing linkage of these preferences to health record information.

Project description:BackgroundRecruiting participants to a clinical study is a resource-intensive process with a high failure rate. The Scottish Health Research Register (SHARE) provides recruitment support service which helps researchers recruit participants by searching patients' Electronic Health Records (EHRs). The current study aims to evaluate the performance of SHARE in participant recruitment.MethodsRecruitment projects eligible for evaluation were those that were conducted for clinical trials or observational studies and finished before 2020. For analysis of recruitment data, projects with incomplete data were excluded. For each project we calculated, from SHARE records, 1) the fraction of the participants recruited through SHARE as a percentage of the number requested by researchers (percentage fulfilled), 2) the percentage of the potential candidates provided by SHARE to researchers that were actually recruited (percentage provided and recruited), 3) the percentage of the participants recruited through SHARE of all the potentially eligible candidates identified by searching registrants' EHRs (percentage identified and recruited). Research teams of the eligible projects were invited to participate in an anonymised online survey. Two metrics were derived from research teams' responses, including a) the fraction of the recruited over the study target number of participants (percentage fulfilled), and b) the percentage of the participants recruited through SHARE among the candidates received from SHARE (percentage provided and recruited).ResultsForty-four projects were eligible for inclusion. Recruitment data for 24 projects were available (20 excluded because of missingness or incompleteness). Survey invites were sent to all the eligible research teams and received 12 responses. Analysis of recruitment data shows the overall percentage fulfilled was 34.2% (interquartile 13.3-45.1%), the percentage provided and recruited 29.3% (interquartile 20.6-52.4%) and percentage identified and recruited 4.9% (interquartile 2.6-10.2%). Based on the data reported by researchers, percentage fulfilled was 31.7% (interquartile 5.8-59.6%) and percentage provided and recruited was 20.2% (interquartile 8.2-31.0%).ConclusionsSHARE may be a valuable resource for recruiting participants for some clinical studies. Potential improvements are to expand the registrant base and to incorporate more data generated during patients' different health care encounters into the candidate-searching step.

Project description:BackgroundRecruitment of patients is one of the main challenges when designing and conducting randomised controlled trials (RCTs). Trials of rare injuries or those that include surgical interventions pose added challenges due to the small number of potentially eligible patients and issues with patient preferences and surgeon equipoise. We explore key issues to consider when recruiting to orthopaedic surgical trials from the perspective of staff and patients with the aim of informing the development of strategies to improve recruitment in future research.DesignTwo qualitative process evaluations of a UK-wide orthopaedic surgical RCT (ACTIVE) and mixed methods randomised feasibility study (PRESTO). Qualitative semi-structured interviews were conducted and data was analysed thematically.SettingNHS secondary care organisations throughout the UK. Interviews were undertaken via telephone.ParticipantsThirty-seven health professionals including UK-based spinal and orthopaedic surgeons and individuals involved in recruitment to the ACTIVE and PRESTO studies (e.g. research nurses, surgeons, physiotherapists). Twenty-two patients including patients who agreed to participate in the ACTIVE and PRESTO studies (n=15) and patients that declined participation in the ACTIVE study (n=7) were interviewed.ResultsWe used a mixed methods systematic review of recruiting patients to randomised controlled trials as a framework for reporting and analysing our findings. Our findings mapped onto those identified in the systematic review and highlighted the importance of equipoise, randomisation, communication, patient's circumstances, altruism and trust in clinical and research teams. Our findings also emphasised the importance of considering how eligibility criteria are operationalised and the impact of complex patient pathways when recruiting to surgical trials. In particular, the influence of health professionals, who are not involved in trial recruitment, on patients' treatment preferences by suggesting they would receive a certain treatment ahead of recruitment consultations should not be underestimated.ConclusionsA wealth of evidence exploring factors affecting recruitment to randomised controlled trials exists. A methodological shift is now required to ensure that this evidence is used by all those involved in recruitment and to ensure that existing knowledge is translated into methods for optimising recruitment to future trials.Trial registrationACTIVE: ( ISRCTN98152560 ). Registered on 06/03/2018. PRESTO: ( ISRCTN12094890 ). Registered on 22/02/2018.

Project description:Study questionWhat is the effect of default test offers--opt-in, opt-out, and active choice--on the likelihood of acceptance of an HIV test among patients receiving care in an emergency department?MethodsThis was a randomized clinical trial conducted in the emergency department of an urban teaching hospital and regional trauma center. Patients aged 13-64 years were randomized to opt-in, opt-out, and active choice HIV test offers. The primary outcome was HIV test acceptance percentage. The Denver Risk Score was used to categorize patients as being at low, intermediate, or high risk of HIV infection.Study answer and limitations38.0% (611/1607) of patients in the opt-in testing group accepted an HIV test, compared with 51.3% (815/1628) in the active choice arm (difference 13.3%, 95% confidence interval 9.8% to 16.7%) and 65.9% (1031/1565) in the opt-out arm (difference 27.9%, 24.4% to 31.3%). Compared with active choice testing, opt-out testing led to a 14.6 (11.1 to 18.1) percentage point increase in test acceptance. Patients identified as being at intermediate and high risk were more likely to accept testing than were those at low risk in all arms (difference 6.4% (3.4% to 9.3%) for intermediate and 8.3% (3.3% to 13.4%) for high risk). The opt-out effect was significantly smaller among those reporting high risk behaviors, but the active choice effect did not significantly vary by level of reported risk behavior. Patients consented to inclusion in the study after being offered an HIV test, and inclusion varied slightly by treatment assignment. The study took place at a single county hospital in a city that is somewhat unique with respect to HIV testing; although the test acceptance percentages themselves might vary, a different pattern for opt-in versus active choice versus opt-out test schemes would not be expected.What this paper addsActive choice is a distinct test regimen, with test acceptance patterns that may best approximate patients' true preferences. Opt-out regimens can substantially increase HIV testing, and opt-in schemes may reduce testing, compared with active choice testing.Funding, competing interests, data sharingThis study was supported by grant NIA 1RC4AG039078 from the National Institute on Aging. The full dataset is available from the corresponding author. Consent for data sharing was not obtained, but the data are anonymized and risk of identification is low.Trial registration Clinical trials NCT01377857.

Dataset Information

Practical application of opt-out recruitment methods in two health services research studies.

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Practical application of opt-out recruitment methods in two health services research studies.

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