Study protocol for an open-label, single-arm, mixed methods feasibility study of the MWIQ AI-powered decision support tool for diabetes management in GP practices

There are a number of inaccuracies in the article by D. Hunter, which the Health Research Authority (HRA) and Medicines and Healthcare Products Regulatory Agency (MHRA) in collaboration would like...

I doubt that personal spats between foot-soldiers will further solutions to the research governance problems unmasked by Paul Stewart and myself in the BMJ last year [1]. Almost 1 year on, I believe progress is unlikely until the monarchs with the money at grant foundations concede that their largesse is being wasted and take sanctions against the robber barons among regulators. What follows therefore is a mere exhibition joust, aimed mainly at our common and worst foe, RD their incompetence and intimidation were not fully manifest at the time of my article [2], but were exposed by the unanimous obloquy directed at them during the meeting of National Institute of Health Research Senior Investigators in April at the Wellcome Trust (http://www.nihr.ac.uk/files/pdfs/DismantlingBarriersWorkshop.pdf).

IntroductionEvidence suggests bowel scope screening (BSS) can significantly reduce an individual’s risk of developing colorectal cancer (CRC). BSS for 55 year olds was therefore introduced to the English Bowel Cancer...

IntroductionDizziness is a common symptom that can occur in an unpredictable and episodic manner leading to the imprecise reporting of symptoms. Patients will often see many specialists before receiving a...

Plain English summaryResearchers carrying out research in the NHS in England have to obtain approval for their study from an NHS Research Ethics Committee (REC). Involving the public in research helps to ensure studies are ethically acceptable to the people taking part, and therefore supports the REC review. The form used by RECs asks researchers to describe any involvement that has taken place before the review or any planned for the future. We analysed researchers’ reports of involvement in 2748 applications to RECs in 2014, to assess how well their approaches to involvement are informing the review process. We found that researchers rarely describe involvement in enough detail to help REC members. It is difficult to judge whether previous involvement has shaped the research design in any way, and whether plans for future involvement are meaningful. It also seems that some researchers remain unclear about involvement and its purpose at different stages. This may be severely limiting its impact.So that public involvement can usefully inform REC reviews in future, the Health Research Authority, which oversees RECs, will carry out further work to find out what information RECS need about involvement. This information will be used to change the application form and to develop guidance and training for REC members and the wider research community. Researchers may also benefit from clearer guidance on the value and purpose of involvement at key research stages: early design, data collection and the dissemination of results.Background Researchers conducting research in the NHS in England are required to submit their study for approval by an NHS Research Ethics Committee (REC). Public involvement in research prior to REC review helps to ensure studies are ethically acceptable to participants, thus informing the review process. The Integrated Research Application System (IRAS) used by RECs, asks researchers to describe any involvement in the development of their project, and in its delivery and dissemination. We analysed researchers’ reports of involvement to assess how well current approaches to involvement are supporting REC review.Methods We used a mixed methods approach. The anonymised free-text data from all 2748 non-educational applications submitted to RECs in 2014 were analysed using NVivo. Themes were developed from the data and used to summarise and categorise the different types of reports of involvement. The frequency of common types of report was analysed using simple statistics.Results In general, researchers rarely describe any prior involvement in sufficient detail to know what was done and what difference this made. This makes it difficult to judge whether the involvement shaped the research design in any way to make it more ethically acceptable. Similarly, researchers’ plans for future involvement are not clear enough to enable RECs to make a proper assessment of whether this involvement will be meaningful, or whether potential ethical concerns raised by involvement have been addressed. This analysis also shows there is still considerable misunderstanding amongst researchers around what involvement means, and its purpose at different stages of a project. This may be severely limiting the potential for impact.Conclusions So that public involvement can usefully inform REC review in future, the HRA is undertaking a collaborative exercise to understand what information RECS need about involvement, and what changes need to be made to the IRAS form. At the same time it will develop guidance and training for REC members and the wider research community about how public involvement can support ethical review. Researchers may also benefit from guidance on the value and purpose of involvement at the research stages: design, data collection and dissemination of results.

Developing an International Core Outcome Set for SSD Interventions

IntroductionIn one-third of all abdominal aortic aneurysms (AAAs), the aneurysm neck is short (juxtarenal) or shows other adverse anatomical features rendering operations more complex, hazardous and expensive. Surgical options include...

IntroductionCongenital heart defect (CHD) is a significant, rapidly emerging global problem in child health and a leading cause of neonatal and childhood death. Prenatal detection of CHDs with the help of ultrasound allows better perinatal management of such pregnancies, leading to reduced neonatal mortality, morbidity and developmental complications. However, there is a wide variation in reported fetal heart problem detection rates from 34% to 85%, with some low- and middle-income countries detecting as low as 9.3% of cases before birth. Research has shown that deep learning-based or more general artificial intelligence (AI) models can support the detection of fetal CHDs more rapidly than humans performing ultrasound scan. Progress in this AI-based research depends on the availability of large, well-curated and diverse data of ultrasound images and videos of normal and abnormal fetal hearts. Currently, CHD detection based on AI models is not accurate enough for practical clinical use, in part due to the lack of ultrasound data available for machine learning as CHDs are rare and heterogeneous, the retrospective nature of published studies, the lack of multicentre and multidisciplinary collaboration, and utilisation of mostly standard planes still images of the fetal heart for AI models. Our aim is to develop AI models that could support clinicians in detecting fetal CHDs in real time, particularly in nonspecialist or low-resource settings where fetal echocardiography expertise is not readily available.Methods and analysisWe have designed the Clinical Artificial Intelligence Fetal Echocardiography (CAIFE) study as an international multicentre multidisciplinary collaboration led by a clinical and an engineering team at the University of Oxford. This study involves five multicountry hospital sites for data collection (Oxford, UK (n=1), London, UK (n=3) and Southport, Australia (n=1)). We plan to curate 14 000 retrospective ultrasound scans of fetuses with normal hearts (n=13 000) and fetuses with CHDs (n=1000), as well as 2400 prospective ultrasound cardiac scans, including the proposed research-specific CAIFE 10 s video sweeps, from fetuses with normal hearts (n=2000) and fetuses diagnosed with major CHDs (n=400). This gives a total of 16 400 retrospective and prospective ultrasound scans from the participating hospital sites. We will build, train and validate computational models capable of differentiating between normal fetal hearts and those diagnosed with CHDs and recognise specific types of CHDs. Data will be analysed using statistical metrics, namely, sensitivity, specificity and accuracy, which include calculating positive and negative predictive values for each outcome, compared with manual assessment.Ethics and disseminationWe will disseminate the findings through regional, national and international conferences and through peer-reviewed journals. The study was approved by the Health Research Authority, Care Research Wales and the Research Ethics Committee (Ref: 23/EM/0023; IRAS Project ID: 317510) on 8 March 2023. All collaborating hospitals have obtained the local trust research and development approvals.

Introduction: Cancer-related fatigue is well described. Fatigue in patients with a malignant pleural effusion (MPE) has not been directly studied. Methods: A prospective observational cohort pilot study ‘Do Interventions for Malignant Pleural Effusions (MPE) impact on patient reported fatigue levels (IMPE-F study)’ is planned to determine whether pleural interventions reduce fatigue in MPE. Fatigue will be assessed with a validated patient reported outcome measure, FACIT-F. Discussion: MPE-F has funding from Rocket Medical Plc, and is part of a Masters in Clinical Research at Newcastle University. Respondent fatigue will be addressed by the investigators going through the questionnaire with the participants. Inclusion criteria are all patients above 18 years of age with a presumed MPE undergoing a procedure and able to consent. The expected number of participants is 50. Trial registration: The IMPE-F study has Research Ethics Committee (REC) [20/YH/0224] and Health Research Authority (HRA) and Health and Care Research Wales (HCRW) approvals [IRAS project ID: 276451]. The study has been adopted on National Institute for Health Research portfolio [CPMS ID 46430].

Early delayed gastric emptying (DGE) occurs in up to 37% of patients following esophagectomy. This can contribute to increased anastomotic leak and respiratory infection rates. Although the treatment of DGE in the form of pyloric balloon dilatation (PBD) post-operatively is well established, there is no consensus on the optimal approach in the prevention of DGE. The aim is to carry out a randomised control trial to determine the efficacy of prophylactic PBD in the prevention of DGE following esophagectomy. This presentation details the protocol, recruitment strategy and potential timeline for a feasibility study addressing this. We detail the rationale, objectives, design, and methods of this study. Patients will be recruited over a three to six-month period (starting in January 2022) and randomised to either a control group (no intervention) or a treatment group (prophylactic PBD). The Chief Investigator has obtained approval from the UK Health Research Authority (HRA) and Research Ethics Committee (REC) on 01/12/21 (IRAS project ID: 287659). As a feasibility study, the objectives will be to ascertain the following: Number of patients approached; Number of patients who agreed to be randomised; Number of patients successfully randomised; Number of patients who dropped out; Successful measurement of outcome measures (delayed gastric emptying, pneumonia, anastomotic leak). Prophylactic pyloric balloon dilatation is potentially a safe and effective procedure which can significantly improve outcomes in patients after an esophagectomy. This protocol describes details for the feasibility study to be carried out which will allow important learning points for the main randomised controlled trial.

Sea Swimming as a Novel Intervention for Depression and Anxiety - a Feasibility Study Exploring Engagement and Effectiveness

Background In April 2019, our hospital transitioned to an electronic patient record system and patient portal (MyGOSH). MyGOSH enables young people aged 12 years or older and their parents to access results, documentation, appointments, and to communicate with their care team. Aims A focus group was conducted to explore the ethical and legal considerations of young people and their parents using a patient portal from the perspective of hospital Ethics Committee members. Participants and research context Members of the hospital Paediatric Bioethics Centre were recruited ( n = 7). Written informed consent was provided by all participants. Research design The focus group discussion was recorded, transcribed verbatim and analysed using thematic analysis. Ethical considerations Health Research Authority Research Ethics Committee (REC) Approval was granted by London Southeast REC (IRAS Project ID: 248793; REC Reference: 18/LO/1945). Results Four themes, and sub-themes, were identified: (1) granting access – complexities of assessing competence/capacity, exclusion from MyGOSH due to non-disclosure of diagnosis, and truth-telling; (2) inequalities resulting in inequities – complexities of inequity in access; (3) responding to change – providing support and managing expectations; (4) engagement, empowerment and understanding – data safety, empowering young people to take ownership of their health data, a one-size fits all system may not meet the needs of all families, and early engagement with young people/parents. Discussion Giving families portal access can increase engagement, empowering them to be more involved in care, yet poses challenges for all. Complexities exist in the assessment for portal access, and supporting and managing user expectations whilst providing an equitable service. Conclusions Ongoing support is required for all stakeholders following patient portal implementation to navigate the ethical and legal complexities, and to promote equity and portal utility for patient benefit.

We have followed with interest the commentaries arising from Moore and Donnellys1 argument that authorities in charge of research ethics committees (RECs) should focus primarily on establishing code-consistent reviews.1 We...

New information has been received that mandates an update to the retraction of “Skin-Derived Fibroblasts for the Treatment of Refractory Achilles Tendinosis: Preliminary Short-Term Results,” by H. Obaid, A. Clarke, P. Rosenfeld, C. Leach, and D. Connell (J Bone Joint Surg Am. 2012 Feb 1;94[3]:). The previously published retraction notice (J Bone Joint Surg Am. 2015 Apr 15;97[8]:) was inaccurate in several respects. The study was initially misclassified as a clinical trial by Dr. Connell, in error; the error was identified by the appropriate authorities during an audit, and Dr. Connell was informed of the problem. Dr. Connell did not reapply for the appropriate authorizations and ethics clearance using the correct classification. Records of the research findings have been requested for review by the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom. They were not received by that agency as of this writing, and we cannot confirm that they are available. Should they become available, that would not affect the retraction of this article, which did not meet our ethics policy criterion regarding institutional review board (IRB) approval or approval by a similar ethics board. To preserve the public record, the retraction notice published on April 15, 2015, is repeated below. Marc F. Swiontkowski, MD Editor-in-Chief Vernon T. Tolo, MD Editor-in-Chief Emeritus Previous Retraction Notice A letter to our readers: We regret to inform you that The Journal of Bone and Joint Surgery must retract “Skin-Derived Fibroblasts for the Treatment of Refractory Achilles Tendinosis: Preliminary Short-Term Results” by H. Obaid, A. Clarke, P. Rosenfeld, C. Leach, and D. Connell. The citation for this article is J Bone Joint Surg Am. 2012 Feb 1;94(3):193-200. The study was initially misclassified as a clinical trial by Dr. Connell, in error, and this error was compounded by the same misclassification by the Joint Royal National Orthopaedic Hospital (RNOH) and Institute of Orthopaedics and Musculoskeletal Science (IOMS) Research Ethics Committee. Thus, the ethics approval for this study that was given by the Joint RNOH/IOMS Research Ethics Committee was issued in error. Initial allegations regarding the conduct of this study largely resulted from the misclassification. Additionally, we have it on authority that records of the research findings were retained and are available. The study did not meet our ethics policy criterion regarding institutional review board (IRB) approval or approval by a similar ethics board, and thus the article must be retracted. Respectfully submitted, Marc F. Swiontkowski, MD Editor-in-Chief Vernon T. Tolo, MD Editor-in-Chief Emeritus

The Confidentiality Advisory Group (CAG) is a specialised body that advises the Health Research Authority (HRA) and the Secretary of State for Health on requests for access to confidential information, in the absence of informed consent from its owners. Its primary role is to oversee the safe use of such information and to counsel the governing bodies mentioned above as to whether such use is appropriate or inappropriate. Researchers who seek access to England or Wales-based confidential data, for medical purposes that are in the interest of the public, are typically required to submit an application to this body. However, it is not always clear to researchers whether requests for access to patient data fit within the remit of the CAG or a Trust’s local information governance team. This commentary will, therefore, explore the role of the CAG and reflect on how best to support researchers with this question.