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Abstract Background Venous leg ulcers (VLUs) can take many months to heal and 25% fail to heal. The main treatment for venous leg ulcers is compression therapy and few additional therapies exist. Two previous trials indicated that low-dose aspirin may improve healing time, but these trials were insufficiently robust. Methods A multi-centred, pilot, phase II, randomised, double blind, parallel-group, placebo-controlled, efficacy trial (RCT) was conducted to determine: if aspirin improves VLU healing time; the safety of aspirin in this population; treatment compliance; and the feasibility of recruitment to a phase III trial. We recruited patients from secondary care who were aged ≥ 18 years, had a chronic VLU and not regularly taking aspirin. Participants were randomly assigned (1:1) to receive 300 mg of daily aspirin or placebo in addition to standard care, which consisted of multi component compression therapy aiming to deliver 40 mmHg at the ankle where possible. The randomisation list was stratified by ulcer size (≤ 5 cm2 or > 5 cm2). The primary endpoint was time to ulcer healing, which was defined as ‘complete epithelial healing in the absence of scab (eschar) with no dressing required’. Safety outcomes were assessed in all participants who received at least one dose of the study drug. Results Twenty-seven patients were recruited from eight sites (target 100 patients). A short time-frame to recruit and a large number of patients failing to meet the eligibility criteria were the main barriers to recruitment. There was no evidence of a difference in time to healing of the reference ulcer following adjustment for log ulcer area and duration (hazard ratio 0.58, 95% confidence interval 0.18 to 1.85; p = 0.357). One expected serious adverse event related to aspirin was recorded. A number of options to improve recruitment were explored. Conclusions There was no evidence that aspirin was effective in expediting the healing of chronic VLUs. However, the analysis was underpowered due to the low number of participants recruited. The trial design would require substantial amendment in order to progress to a phase III (effectiveness) trial. Trial registration Clinicaltrials.gov, NCT02333123. Registered on 5 November 2014.

Objective: To describe the use of computing systems by primary care staff in Scotland. Participants Practice managers in Scotland on behalf of their practice teams. Methods: A survey of computer use in Scottish general practices was carried out by the Scottish Clinical Information Management in Primary Care (SCIMP) group in April 2001. Every practice was sent an electronic copy of a questionnaire using NHSnet. Practices that did not respond to the electronic version were sent a paper version of the questionnaire. Main outcome measures: Access to computers, use during consultations, links to laboratories, problems experienced by users. Results: A total of 308 practices (30%) replied to the electronic questionnaire and 346 practices (33%) to a paper version, giving an overall response rate of 63% (654 practices). A total of 296 (29%) of practices could not receive the electronic version. It was reported that 94% of general practitioners and 74% of practice nurses frequently used a computer; 72% of practices used their computer for chronic disease management. There was great variability in links to laboratories for lab results (range 1-30% by region). Of responding practices, 16% had plans for a unified patient record, but access to a computer is still a major problem for community nurses. Satisfaction was expressed for all systems and many practices also use third-party programs. Conclusions: Most Scottish doctors make frequent use of computers for a variety of clinical and practice management activities. Many other staff want to make greater use of computers, but are often unable to obtain access. [ABSTRACT FROM AUTHOR]

Abstract Background Negative pressure wound therapy (NPWT) is widely promoted as a treatment for full thickness wounds; however, there is a lack of high-quality research evidence regarding its clinical and cost effectiveness. A trial of NPWT for the treatment of grade III/IV pressure ulcers would be worthwhile but premature without assessing whether such a trial is feasible. The aim of this pilot randomised controlled trial was to assess the feasibility of conducting a future full trial of NPWT for the treatment of grade III and IV pressure ulcers and to pilot all aspects of the trial. Methods This was a two-centre (acute and community), pilot randomised controlled trial. Eligible participants were randomised to receive either NPWT or standard care (SC) (spun hydrocolloid, alginate or foam dressings). Outcome measures were time to healing of the reference pressure ulcer, recruitment rates, frequency of treatment visits, resources used and duration of follow-up. Results Three hundred and twelve patients were screened for eligibility into this trial over a 12-month recruitment period and 12/312 participants (3.8%) were randomised: 6 to NPWT and 6 to SC. Only one reference pressure ulcer healed (NPWT group) during follow-up (time to healing 79 days). The mean number of treatment visits per week was 3.1 (NPWT) and 5.7 (SC); 6/6 NPWT and 1/6 SC participants withdrew from their allocated trial treatment. The mean duration of follow-up was 3.8 (NPWT) and 5.0 (SC) months. Conclusions This pilot trial yielded vital information for the planning of a future full study including projected recruitment rate, required duration of follow-up and extent of research nurse support required. Data were also used to inform the cost-effectiveness and value of information analyses, which were conducted alongside the pilot trial. Trial registration Current Controlled Trials ISRCTN69032034.

Abstract Background Proximal humeral fractures, which occur mainly in older adults, account for approximately 4 to 5% of all fractures. Approximately 40% of these fractures are displaced fractures involving the surgical neck. Management of this group of fractures is often challenging and the outcome is frequently unsatisfactory. In particular it is not clear whether surgery gives better outcomes than non-surgical management. Currently there is much variation in the use of surgery and a lack of good quality evidence to inform this decision. Methods/Design We aim to undertake a pragmatic UK-based multi-centre randomised controlled trial evaluating the effectiveness and cost-effectiveness of surgical versus standard non-surgical treatment for adults with an acute closed displaced fracture of the proximal humerus with involvement of the surgical neck. The choice of surgical intervention is left to the surgeon, who must use techniques that they are fully experienced with. This will avoid 'learning curve' problems. We will promote good standards of non-surgical care, similarly insisting on care-provider competence, and emphasize the need for comparable provision of rehabilitation for both groups of patients. We aim to recruit 250 patients from a minimum of 18 NHS trauma centres throughout the UK. These patients will be followed-up for 2 years. The primary outcome is the Oxford Shoulder Score, which will be collected via questionnaires completed by the trial participants at 6, 12 and 24 months. This is a 12-item condition-specific questionnaire providing a total score based on the person's subjective assessment of pain and activities of daily living impairment. We will also collect data for other outcomes, including general health measures and complications, and for an economic evaluation. Additionally, we plan a systematic collection of reasons for non-inclusion of eligible patients who were not recruited into the trial, and their baseline characteristics, treatment preferences and intended treatment. Discussion This article presents the protocol for a multi-centre randomised controlled trial. It gives extensive details of, and the basis for, the chosen methods, and describes the key measures taken to avoid bias and to ensure validity. Trial Registration Current Controlled Trials ISRCTN50850043

Two hundred and fifty two of the patients referred to a rapid access clinic (that's 52%) were judged not to have cardiac pain. When surveyed eight months later half of the 69% who responded said they were still having chest pain. Women were more likely than men to be still suffering symptoms. More than 50% were still not convinced that their pain was not heart pain. The authors note that there is 'an ongoing challenge' to provide more support for these patients. [ABSTRACT FROM AUTHOR]

Introduction: The pandemic saw widespread use of home pulse oximeters to patients diagnosed with COVID-19 to support early detection of low oxygen saturation levels and appropriate care. Rapid implementation made conventional evaluation challenging, highlighting the need for rigorous non-randomised methods to support decision-making about future use of these technologies. We used routine data to explore the benefits of pulse oximetry in Greater Manchester, under the 'COVID-19 oximetry at home' (CO@h) programme., Methods: We used data from the Greater Manchester Secure Data Environment and defined study parameters using a 'target trial' model to compare patients receiving pulse oximetry under the CO@h programme, with matched controls using various comparator groups. Primary outcomes were unplanned hospitalisation and all-cause mortality. This study is based on data from the Greater Manchester Care Record (GMCR), using anonymised, routinely collected data provided in a de-identified format for research. Informed written consent is needed for primary care patient data to be collected for service improvement and research, before data extraction to the GMCR. The study was approved under protocol GMCR RQ-048, on 12/05/2022. As indicated by the University of Manchester ethics decision tool, formal ethical approval was not required for this study., Results: The adjusted odds ratios for an unplanned hospitalisation were higher among patients receiving pulse oximetry: OR 1.86 (95% CI 1.54-2.25) at 28 days, 1.5 (95% CI 1.3-1.74) at 90 days and 1.63 (95% CI 1.44-1.83) at 1 year. Overall odds of mortality were lower among patients receiving pulse oximetry: adjusted ORs of 0.5 (95% CI 0.25-0.98) at 28 days, 0.5 (95% CI 0.32-0.78) at 90 days and 0.58 (95% CI 0.44-0.76) at 1 year. The results were robust to different comparison groups., Conclusion: Use of pulse oximetry at home under the CO@h programme, through the resulting prioritisation for appropriate care, was associated with a higher frequency of unplanned admissions and a reduction in the risk of mortality up to 1 year later. Therefore, it is likely effective for early detection of clinical deterioration and timely intervention among patients with COVID-19. Further research is needed to understand whether this is a cost-effective use of healthcare resources., Competing Interests: RW, JD, PB, FR and EK were supported by the NIHR Applied Research Collaboration Greater Manchester (NIHR200174) and RW and JD by the NIHR Manchester Biomedical Research Centre (NIHR203308). As explained in the data availability section, there are restrictions using patient level data and we cannot freely share the data used in this paper through the journal., (Copyright: © 2024 Rubinstein et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background and Objective: Randomized controlled trials (RCTs) inform health-care decisions. Unfortunately, some published RCTs contain false data, and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesize all RCTs which have been conducted on a given topic. This means that any of these 'problematic studies' are likely to be included, but there are no agreed methods for identifying them. The INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project is developing a tool to identify problematic RCTs in systematic reviews of health care-related interventions. The tool will guide the user through a series of 'checks' to determine a study's authenticity. The first objective in the development process is to assemble a comprehensive list of checks to consider for inclusion., Methods: We assembled an initial list of checks for assessing the authenticity of research studies, with no restriction to RCTs, and categorized these into five domains: Inspecting results in the paper; Inspecting the research team; Inspecting conduct, governance, and transparency; Inspecting text and publication details; Inspecting the individual participant data. We implemented this list as an online survey, and invited people with expertise and experience of assessing potentially problematic studies to participate through professional networks and online forums. Participants were invited to provide feedback on the checks on the list, and were asked to describe any additional checks they knew of, which were not featured in the list., Results: Extensive feedback on an initial list of 102 checks was provided by 71 participants based in 16 countries across five continents. Fourteen new checks were proposed across the five domains, and suggestions were made to reword checks on the initial list. An updated list of checks was constructed, comprising 116 checks. Many participants expressed a lack of familiarity with statistical checks, and emphasized the importance of feasibility of the tool., Conclusion: A comprehensive list of trustworthiness checks has been produced. The checks will be evaluated to determine which should be included in the INSPECT-SR tool., Competing Interests: Declaration of competing interest J.W., CH, GAA., L.B., and J.J.K. declare funding from NIHR (NIHR203568) in relation to the current project. J.W. additionally declares Stats or Methodological Editor roles for BJOG, Fertility and Sterility, Reproduction and Fertility, Journal of Hypertension, and for Cochrane Gynecology and Fertility. C.H. declares a Statistical Editor role for Cochrane Colorectal. L.B. additionally declares a role as Academic Meta-Research Editor for PLoS Biology, and that The University of Colorado receives remuneration for service as Senior Research Integrity Editor, Cochrane. J.J.K. additionally declares a Statistical Editor role for The BMJ. A.A. declares that The Health Services Research Unit, University of Aberdeen, is funded by the Health and Social Care Directorates of the Scottish Government. V.B. is EiC of the Medical Journal of Australia and on the Editorial Board of Research Integrity and Peer Review. N.J.L.B. declares roles as Editorial Board member for International Review of Social Pyschology/Revue Internationale de Psychologie Sociale, Statistical Advisory Board member for Mental Health Science, and Advisory Board member for Meta-Psychology. M.C. declares that he is Co-ordinating Editor for the Cochrane Methodology Review Group, Editor in Chief, Journal of Evidence-Based Medicine, and Coordinating Editor, James Lind Library. E.F., S.G., and T.La. declare employment by Cochrane. E.F. additionally declares a role as Editorial Board member for Cochrane Synthesis and Methods. T.La. additionally declares authorship of a chapter in the Cochrane Handbook for Systematic Reviews of Interventions and that he is a developer of standards for Cochrane intervention reviews (MECIR). T.Li. is funded by the National Eye Institute, National Institutes of Health (Grant #UG1 EY020522). S.L. is funded by NHMRC (APP1195189), and holds general or methodological editor positions for Cochrane Gynecology and Fertility, Fertility and Sterility, and Human Reproduction. A.L. is on the editorial board of BMC Medical Ethics. B.W.M. declares roles as Editor for Cochrane Gynecology and Fertility and Sexually Transmitted Infections, and for Fertility and Sterility. S.L. declares roles as Associate Editor for Human Reproduction, Methodological Editor for Fertility and Sterility, and Editor for Cochrane Gynecology and Fertility. N.O.C. is a member of the Cochrane Editorial Board and holds an ERA-NET Neuron Cofund grant for a separate project. A.L.S. declares funding from Australian National Health and Medical Research Council Investigator Grants (GNT2009432). E.S. is a Sign-off Editor for the Cochrane Library. M.v.W. is coordinating editor of Cochrane Gynecology and Fertility and Cochrane Sexually Transmitted Infections, Methodological Editor of Human Reproduction Update and editorial Editor of Fertility and Sterility. There are no competing interests for any other author., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objective: Groups which are marginalised, disadvantaged or otherwise vulnerable have lower uptake of vaccinations. This differential has been amplified in COVID-19 vaccination compared to (e.g.) influenza vaccination. This overview assessed the effectiveness of interventions to increase vaccination in underserved, minority or vulnerable groups., Methods: In November 2022 we searched four databases for systematic reviews that included RCTs evaluating any intervention to increase vaccination in underserved, minority or vulnerable groups; our primary outcome was vaccination. We used rapid review methods to screen, extract data and assess risk of bias in identified reviews. We undertook narrative synthesis using an approach modified from SWiM guidance. We categorised interventions as being high, medium or low intensity, and as targeting vaccine demand, access, or providers., Results: We included 23 systematic reviews, including studies in high and low or middle income countries, focused on children, adolescents and adults. Groups were vulnerable based on socioeconomic status, minority ethnicity, migrant/refugee status, age, location or LGBTQ identity. Pregnancy/maternity sometimes intersected with vulnerabilities. Evidence supported interventions including: home visits to communicate/educate and to vaccinate, and facilitator visits to practices (high intensity); telephone calls to communicate/educate, remind/book appointments (medium intensity); letters, postcards or text messages to communicate/educate, remind/book appointments and reminder/recall interventions for practices (low intensity). Many studies used multiple interventions or components., Conclusion: There was considerable evidence supporting the effectiveness of communication in person, by phone or in writing to increase vaccination. Both high and low intensity interventions targeting providers showed effectiveness. Limited evidence assessed additional clinics or targeted services for increasing access; only home visits had higher confidence evidence showing effectiveness. There was no evidence for interventions for some communities, such as religious minorities which may intersect with gaps in evidence for additional services. None of the evidence related to COVID-19 vaccination where inequalities of outcome are exacerbated., Prospero Registration: CRD42021293355., (© 2024. The Author(s).)

Purpose: To gain an understanding of the nursing professionals who treat people with malignant fungating wounds (MFW) in the UK and their current practices, including perceived barriers and facilitators to providing MFW care., Method: An online anonymous questionnaire was created with questions about the role of nursing professionals who reported caring for patients with MFW, the number of people with MFW they regularly cared for, treatment aims, treatments used, and challenges faced. These questions were developed with professional input and piloted. Using a convenience sampling method, we collected responses from UK nurses by distributing the questionnaire via social media and through relevant professional organisations. The questionnaire was constructed in QualtricsXM software and analysed using SPSS., Result: We received 154 questionnaire responses, with three-quarters from tissue viability nurses and the rest from community and other specialist nurses. The most important treatment aim reported was pain management, followed by odour management. Almost all respondents used antimicrobial and standard dressings for these patients, with a range of products reported. Poor access to MFW care training and lack of local and national guidelines were reported as barriers to providing care for people with MFW. Availability of dressings, access to training, and good communication processes were reported as facilitators., Conclusion: This is the first study to explore MFW wound care practices in the UK. A range of nurses are involved in care delivery with variations in the treatments used. Lack of access to MFW care training, resources, and standardised guidelines may impede care delivery., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests. Susy Pramod reports financial support and article publishing charges were provided by United Kingdom National Institute for Health and Care Research (NIHR) Applied Research Collaboration Greater Manchester (ARC-GM). If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Crown Copyright © 2024. Published by Elsevier Ltd. All rights reserved.)

Background: Technology-enabled inpatient-level care at home services, such as virtual wards and hospital at home, are being rapidly implemented. This is the first systematic review to link the components of these service delivery innovations to evidence of effectiveness to explore implications for practice and research., Methods: For this review (registered here https://osf.io/je39y ), we searched Cochrane-recommended multiple databases up to 30 November 2022 and additional resources for randomised and non-randomised studies that compared technology-enabled inpatient-level care at home with hospital-based inpatient care. We classified interventions into care model groups using three key components: clinical activities, workforce, and technology. We synthesised evidence by these groups quantitatively or narratively for mortality, hospital readmissions, cost-effectiveness and length of stay., Results: We include 69 studies: 38 randomised studies (6413 participants; largely judged as low or unclear risk of bias) and 31 non-randomised studies (31,950 participants; largely judged at serious or critical risk of bias). The 69 studies described 63 interventions which formed eight model groups. Most models, regardless of using low- or high-intensity technology, may have similar or reduced hospital readmission risk compared with hospital-based inpatient care (low-certainty evidence from randomised trials). For mortality, most models had uncertain or unavailable evidence. Two exceptions were low technology-enabled models that involve hospital- and community-based professionals, they may have similar mortality risk compared with hospital-based inpatient care (low- or moderate-certainty evidence from randomised trials). Cost-effectiveness evidence is unavailable for high technology-enabled models, but sparse evidence suggests the low technology-enabled multidisciplinary care delivered by hospital-based teams appears more cost-effective than hospital-based care for those with chronic obstructive pulmonary disease (COPD) exacerbations., Conclusions: Low-certainty evidence suggests that none of technology-enabled care at home models we explored put people at higher risk of readmission compared with hospital-based care. Where limited evidence on mortality is available, there appears to be no additional risk of mortality due to use of technology-enabled at home models. It is unclear whether inpatient-level care at home using higher levels of technology confers additional benefits. Further research should focus on clearly defined interventions in high-priority populations and include comparative cost-effectiveness evaluation., Trial Registration: https://osf.io/je39y ., (© 2024. The Author(s).)

Background: The VenUS 6 parallel-group randomised controlled trial (RCT) will compare the clinical and cost-effectiveness of compression wraps, two-layer compression bandage and evidence-based compression therapy, comprising of two-layers of hosiery or four-layer bandages, for healing time of venous leg ulcers. We will conduct an embedded process evaluation to evaluate the implementation of the trial and the various compression therapies and to gain a more in-depth understanding of trial participant and nursing staff views and experiences of these therapies., Methods: This process evaluation will be a mixed-method study, embedded into a wider RCT. Qualitative data will be collected through semi-structured individual in-depth interviews with trial participants and staff members. Quantitative data will be collected using patient questionnaires and case report forms that are part of the main trial data collection process. Interview transcripts will be analysed using the Framework Analysis and interview data will be integrated with quantitative RCT data using the RE-AIM framework and the Pillar Integration Process., Discussion: We describe the protocol for a process evaluation, designed to assess the implementation of the various venous leg ulcer compression therapies as evaluated in VenUS6, and the experiences of trial participants and nursing staff using these. This protocol provides one example of how an embedded mixed-method process evaluation can be conducted., Trial Registration: ISRCTN 67321719 ( https://doi.org/10.1186/ISRCTN67321719 ). Prospectively registered on 14 September 2020. Recruitment Infographic SWAT-MRC Hub for Trials Methodology Research SWAT repository #116. Registered on 13 April 2020. Retention Thank You Card SWAT-MRC Hub for Trials Methodology Research SWAT repository #119. Registered on 13 April 2020. Retention Newsletter SWAT-MRC Hub for Trials Methodology Research SWAT repository #28. Registered on 01 July 2007. Retention Pen SWAT-MRC Hub for Trials Methodology Research SWAT repository #92. Registered on 01 April 2019., Protocol Version: V1.5, 26 May 2022., (© 2023. The Author(s).)