Is bureaucracy being busted in research ethics and governance for health services research in the UK? Experiences and perspectives reported by stakeholders through an online survey

Background: It has long been noted that the chain from identification of need (research gap) to impact in the real world is both long and tortuous. This study aimed to contribute evidence about research ethics and governance arrangements and processes in the UK with a focus on: what works well; problems; impacts on delivery; and potential improvements. Methods: Online questionnaire widely distributed 20th May 2021, with request to forward to other interested parties. The survey closed on 18th June 2021. Questionnaire included closed and open questions related to demographics, role, study objectives. Results: Responses were received from 252 respondents, 68% based in universities 25% in the NHS. Research methods used by respondents included interviews/focus groups (64%); surveys/questionnaires (63%); and experimental/quasi experimental (57%). Respondents reported that participants in the research they conducted most commonly included: patients (91%); NHS staff (64%) and public (50%). Aspects of research ethics and governance reported to work well were: online centralised systems; confidence in rigorous, respected systems; and helpful staff. Problems with workload, frustration and delays were reported, related to overly bureaucratic, unclear, repetitive, inflexible and inconsistent processes. Disproportionality of requirements for low-risk studies was raised across all areas, with systems reported to be risk averse, defensive and taking little account of the risks associated with delaying or deterring research. Some requirements were reported to have unintended effects on inclusion and diversity, particularly impacting Patient and Public Involvement (PPI) and engagement processes. Existing processes and requirements were reported to cause stress and demoralisation, particularly as many researchers are employed on fixed term contracts. High negative impacts on research delivery were reported, in terms of timescales for completing studies, discouraging research particularly for clinicians and students, quality of outputs and costs. Suggested improvements related to system level changes / overall approach and specific refinements to existing processes. Conclusions: Consultation with those involved in Health Services Research in the UK revealed a picture of overwhelming and increasing bureaucracy, delays, costs and demoralisation related to gaining the approvals necessary to conduct research in the NHS. Suggestions for improvement across all three areas focused on reducing duplication and unnecessary paperwork/form filling and reaching a better balance between risks of harm through research and harms which occur because research to inform practice is delayed or deterred

Patient and clinician factors associated with prehospital pain treatment and outcomes: cross sectional study

Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.Objective: We aimed to identify how patient (age, sex, condition) and paramedic factors (sex, role) affected prehospital analgesic administration and pain alleviation. Methods: We used a cross-sectional design with a 7-day retrospective sample of adults aged 18 years or over requiring primary emergency transport to hospital, excluding patients with Glasgow Coma Scale below 13, in two UK ambulance services. Multivariate multilevel regression using Stata 14 analysed factors independently associated with analgesic administration and a clinically meaningful reduction in pain (≥2 points on 0–10 numerical verbal pain score [NVPS]). Results: We included data on 9574 patients. At least two pain scores were recorded in 4773 (49.9%) patients. For all models fitted there was no significant relationship between analgesic administration or pain reduction and sex of the patient or ambulance staff. Reduction in pain (NVPS ≥2) was associated with ambulance crews including at least one paramedic (odds ratio [OR] 1.52, 95% confidence interval [CI] 1.14 to 2.04, p < 0.01), with any recorded pain score and suspected cardiac pain (OR 2.2, 95% CI 1.02 to 4.75). Intravenous morphine administration was also more likely where crews included a paramedic (OR 2.82, 95% CI 1.93 to 4.13, P < 0.01), attending patients aged 51 to 64 years (OR 2.04, 95% CI 1.21 to 3.45, p = 0.01), in moderate to severe (NVPS 4–10) compared with lower levels of pain for any clinical condition group compared with the reference condition. Conclusion: There was no association between patient sex or ambulance staff sex or grade and analgesic administration or pain reduction.Peer reviewedFinal Accepted Versio

Patient Perspectives on the Acceptability of Emergency Admission Risk Prediction: A Focus Group Study

Background: Emergency admission risk stratification (EARS) tools predict admission risk for a general practice patient population. Policy has encouraged targeting higher risk patients with proactive care approaches, in partnership with patients. Previously published stakeholder views on the acceptability and use of EARS tools have been limited to professionals. Objective: Our objective was to explore the views of patients on acceptability, benefits, challenges and risks of communicating emergency admission risk scores to patients. Design, setting and participants: We undertook an in-person focus group with a geographically diverse group of patient and public members in Wales, UK. Participants brought experience of multiple health providers. All had chronic conditions and/or recent experience of emergency admission to hospital. We coded and thematically analyzed the transcript. Results: Participants supported the use of EARS where it was underpinned by communication of risk scores and direct involvement of patients. Participants expressed a desire to receive their own risk scores. They felt EARS use was well suited to holistic approaches to care, and as a stimulus to self-management. They recognized capacity and cost challenges related to general practitioner use but saw potential for other primary and community staff to be involved. The security and integrity of EARS data was deemed important. Conclusions: This study provides a rare insight from a stakeholder group that has largely been excluded from debates around EARS use. These findings identify issues that are deserving of further exploration to improve our understanding of the potential role and effectiveness of EARS and other risk approaches in healthcare. Patient or public contribution: This study was conceived following discussion with public contributors to a trial of emergency admission risk stratification (PRISMATIC) [1], and a subsequent informal workshop with eight members of a patient, carer and public member group aligned to research around chronic conditions management in Wales, UK [2]. This preliminary work emphasized the importance of patient involvement in debates around EARS and contributed to the study reported here and to the information sheet and topic guide. JD, a public contributor, was a co-applicant on PRISMATIC, took part in a preliminary workshop, and is a co-author of this paper

Qualitative research within trials: developing a standard operating procedure for a clinical trials unit

BackgroundQualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design.MethodsHealth services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP).ResultsThe qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component.ConclusionsWe recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trial

Primary Care Service Utilization Among People at High Risk of Fatal Opioid Overdose: A Short Communication on an Autopsy Study

Objectives: We sought to explore the sociodemographics and primary care service utilization among people who died from opioid overdose and to assess the possibility of using this information to identify those at high risk of opioid overdose using routine linked data. Methods: Data related to decedents of opioid overdose between January 1, 2012 and December 31, 2015 were linked with general practitioner (GP) records over a period of 36 months prior to death. Results: Of n = 312 decedents of opioid overdose, 73% were male (n = 228). Average age at death was 40.72 (SD 11.92) years. A total of 63.8% of the decedents were living in the 2 most deprived quintiles according to the Welsh Index of Multiple Deprivation. Over 80% (n = 258) of the decedents were recorded as having at least 1 GP episode during the 36-month observation period prior to death. The median number of episodes per decedent was 75 [38-118]. Overall, 31.8% (n = 82) of decedents with at least 1 GP episode received a prescription for a proton pump inhibitor and 31% (n = 80) were prescribed a broad-spectrum antibiotic. According to their GP records, less than 10% were referred to or receiving specialist drug treatment (n = 24, 9.3%); or were known to be drug dependent (n = 21, 8.14%), or a drug user (n = 5, 1.94%). In all, 81% were recorded as smokers (n = 209) and 10.5% as ex-smokers (n = 27). Conclusions: The majority of decedents of opioid overdose were in contact with GP services prior to death. GPs are either often unaware of high-risk opioid use, or rarely record details of opioid use in patient notes. It is possible that GP awareness of high-risk opioid use could be increased. For example, awareness of the risks associated with opioid use, and the relationship between the sociodemographic and clinical characteristics of opioid overdose decedents could be raised using educational materials prominently displayed in waiting areas. Clinicians in primary care may be in an excellent position to intervene in problematic opioid use