Early experience with an opt-in research register - Scottish Health Research Register (SHARE): a multi-method evaluation of participant recruitment performance

Background Recruiting 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. Methods Recruitment 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). Results Forty-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%). Conclusions SHARE 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.

“I am in other people's hands as regards my health” A sociological critique of health care encounters of people with cirrhosis. A secondary analysis

Objectives People with cirrhosis are encouraged to participate in shared decision-making with their doctors, but studies suggest that doctors limit the amount of information that is shared. In this study we explore the presence of medical power in clinical encounters in 2015 from a patient perspective and highlight its effects on healthcare interactions. Methods Qualitative semi-structured interviews were conducted with ten people with cirrhosis attending a tertiary liver transplant centre in southern England. We explored their understanding of their disease and prognosis, and their participation in decision-making. Using the lens of medical power as a framework, we analysed findings into thematic sentences to summarise key ideas whilst preserving the complexity of identified concepts. Results Three key concepts explained patient perspectives of their communication with doctors: (1) portraying a positive image to doctors, (2) avoiding confrontation with doctors, (3) feeling powerless in the face of doctors’ medical knowledge. These concepts show deeper dynamic issues of power during healthcare encounters, illustrated by participants’ reluctance to voice their concerns and express themselves, challenge decisions, or seek information. Conclusion People with cirrhosis struggle to articulate their concerns or challenge decisions on their care and treatment and may worry about potential consequences. Our findings demonstrate the continuing persistence of issues of power at play in contemporary health care.

Evaluating the quality of asynchronously versus synchronously delivered virtual care: Differences in rates of reported medication side effects by patients on a direct-to-consumer telehealth platform (Preprint)

BACKGROUND End-to-end asynchronous health care encounters are becoming an increasingly mainstream form of telehealth. Unlike synchronous telehealth, policy makers and other key health care stakeholders have been hesitant to fully embrace the fully asynchronous modality, especially in the context of direct-to-consumer (DTC) platforms where encounters are patient-initiated and there is no pre-established relationship with their provider. This hesitation is compounded by limited research comparing outcomes between asynchronous and synchronous care, especially in the DTC context. OBJECTIVE The purpose of this study is to explore whether entirely asynchronous care leads to different patient outcomes in the form of medication-related adverse events when compared to synchronous virtual care METHODS Using 10,000 randomly sampled patient records from a prominent, U.S. based DTC platform, we analyzed rates of patient-reported side effects from commonly prescribed medications and compared these rates across modalities of treatment RESULTS Fully end-to-end asynchronous care resulted in lower but nonsignificant rates of reported drug-related side effects compared to synchronous treatment. CONCLUSIONS In some circumstances, fully asynchronous care may not create unsafe prescribing conditions when compared to synchronous care. More research is needed to evaluate the safety of asynchronous care across a wider set of circumstances and measures.

Early Experience with An Opt-In Research Register - Scottish Health Research Register (SHARE): A Multi-Method Evaluation of Participant Recruitment Performance.

Background Recruiting participants to a clinical study is a resource-intensive process and has high rate of failure. 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. Methods Recruitment projects eligible for evaluation were those for clinical trials or observational studies and had finished before the end of 2019. From SHARE records, for each project we calculated 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). Results 44 projects were eligible for inclusion. Recruitment data for 24 projects were collected (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%). Conclusions SHARE 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.

Integrating data from multiple Finnish biobanks and national health-care registers for retrospective studies: Practical experiences

Aim: This case study aimed to investigate the process of integrating resources of multiple biobanks and health-care registers, especially addressing data permit application, time schedules, co-operation of stakeholders, data exchange and data quality. Methods: We investigated the process in the context of a retrospective study: Pharmacogenomics of antithrombotic drugs (PreMed study). The study involved linking the genotype data of three Finnish biobanks (Auria Biobank, Helsinki Biobank and THL Biobank) with register data on medicine dispensations, health-care encounters and laboratory results. Results: We managed to collect a cohort of 7005 genotyped individuals, thereby achieving the statistical power requirements of the study. The data collection process took 16 months, exceeding our original estimate by seven months. The main delays were caused by the congested data permit approval service to access national register data on health-care encounters. Comparison of hospital data lakes and national registers revealed differences, especially concerning medication data. Genetic variant frequencies were in line with earlier data reported for the European population. The yearly number of international normalised ratio (INR) tests showed stable behaviour over time. Conclusions: A large cohort, consisting of versatile individual-level phenotype and genotype data, can be constructed by integrating data from several biobanks and health data registers in Finland. Co-operation with biobanks is straightforward. However, long time periods need to be reserved when biobank resources are linked with national register data. There is a need for efforts to define general, harmonised co-operation practices and data exchange methods for enabling efficient collection of data from multiple sources.

Boundary-Work and the Distribution of Care for Survivors of Domestic Violence and Abuse in Primary Care Settings: Perspectives From U.K. Clinicians

Health care encounters are opportunities for primary care practitioners to identify women experiencing domestic violence and abuse (DVA). Increasing DVA support in primary care is a global policy priority but discussion about DVA during consultations remains rare. This article explores how primary care teams in the United Kingdom negotiate the boundaries of their responsibilities for providing DVA support. In-depth interviews were undertaken with 13 general practitioners (GPs) in two urban areas of the United Kingdom. Interviews were analyzed thematically. Analysis focused on the boundary practices participants undertook to establish their professional remit regarding abuse. GPs maintained permeable boundaries with specialist DVA support services. This enabled ongoing negotiation of the role played by clinicians in identifying DVA. This permeability was achieved by limiting the boundaries of the GP role in the care of patients with DVA to identification, with the work of providing support distributed to local specialist DVA agencies.