A survey of experts to identify methods to detect problematic studies: Stage 1 of the INSPECT-SR Project.

Background: Randomised controlled trials (RCTs) inform healthcare decisions. Unfortunately, some published RCTs contain false data, and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise 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 INSPECT-SR project is developing a tool to identify problematic RCTs in systematic reviews of healthcare-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 categorised 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. Conclusions: 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.

Inpatient-level care at home delivered by virtual wards and hospital at home: a systematic review and meta-analysis of complex interventions and their components.

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 .

Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions.

INTRODUCTION: Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare-related interventions. METHODS AND ANALYSIS: The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: (1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, (2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, (3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in, (4) a consensus meeting to select checks to be included in a draft tool and to determine its format and (5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies and will help patients by protecting them from the influence of false data on their healthcare. ETHICS AND DISSEMINATION: The University of Manchester ethics decision tool was used, and this returned the result that ethical approval was not required for this project (30 September 2022), which incorporates secondary research and surveys of professionals about subjects relating to their expertise. Informed consent will be obtained from all survey participants. All results will be published as open-access articles. The final tool will be made freely available.

Compression therapies for the treatment of venous leg ulcers: study protocol for a process evaluation in a randomised controlled trial, VenUS 6.

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.

Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions.

Introduction: Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INSPECT-SR project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare related interventions. Methods and analysis: The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: 1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, 2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, 3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in 4) a consensus meeting to select checks to be included in a draft tool and to determine its format, 5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies, and will help patients by protecting them from the influence of false data on their healthcare.

Barriers and facilitators to use of compression therapy by people with venous leg ulcers: A qualitative exploration.

AIMS: To explore barriers to, and facilitators of, adherence to compression therapy, from the perspective of people with venous leg ulcers. DESIGN: An interpretive, qualitative, descriptive study involving interviews with patients. METHODS: Participants were purposively sampled from respondents to a survey exploring attitudes to compression therapy in people with venous leg ulcers. Sampling continued until data saturation: 25 interviews between December 2019 and July 2020. Inductive thematic analysis of interview transcripts was undertaken to create a framework for the data, followed by deductive analysis informed by the Common-Sense Model of Self-Regulation. RESULTS: A range of knowledge and understanding about the cause of venous leg ulcers and the mechanisms of compression therapy was demonstrated, which was not particularly related to adherence. Participants talked about their experience with different compression methods and their concerns about the length of time healing could take. They also spoke about aspects of the organization of services which affected their care. CONCLUSION: Identifying specific, individual barriers/facilitators to compression therapy is not simple, rather factors combine to make adherence more or less likely or possible. There was no clear relationship between an understanding of the cause of VLUs or the mechanism of compression therapy and adherence; different compression therapies presented different challenges for patients; unintentional non-adherence was frequently mentioned; and the organization of services could impact on adherence. Ways in which people could be supported to adhere to compression therapy are indicated. Implications for practice include issues relating to communication with patients; taking into account patients' lifestyles and ensuring that they know about useful 'aids'; providing services that are accessible and provide continuity of appropriately trained staff; minimizing unintentional non-adherence; and acknowledging that healthcare professionals will always need to support/advise those who cannot tolerate compression. IMPACT: Compression therapy is a cost-effective, evidence-based treatment for venous leg ulcers. However, there is evidence that patients do not always adhere to this therapy and there is limited research investigating reasons why patients do not wear compression. The study found no clear relationship between an understanding of the cause of VLUs or the mechanism of compression therapy and adherence; that different compression therapies presented different challenges for patients; that unintentional non-adherence was frequently mentioned and that the organization of services could impact on adherence. Attending to these findings offers the opportunity to increase the proportion of people undergoing appropriate compression therapy and achieving complete wound healing, the main outcome desired by this group. PATIENT/PUBLIC CONTRIBUTION: A patient representative sits on the Study Steering Group, contributing to the work from developing the study protocol and interview schedule to interpretation and discussion of findings. Members of a Wounds Research Patient and Public Involvement Forum were consulted about interview questions.

Effect of encouraging awareness of reduced fetal movement and subsequent clinical management on pregnancy outcome: a systematic review and meta-analysis.

OBJECTIVE: Reduced fetal movement, defined as a decrease in the frequency or strength of fetal movements as perceived by the mother, is a common reason for presentation to maternity care. Observational studies have demonstrated an association between reduced fetal movement and stillbirth and fetal growth restriction related to placental insufficiency. However, individual intervention studies have described varying results. This systematic review and meta-analysis aimed to determine whether interventions aimed at encouraging awareness of reduced fetal movement and/or improving its subsequent clinical management reduce the frequency of stillbirth or other important secondary outcomes. DATA SOURCES: Searches were conducted in MEDLINE, Embase, CINAHL, The Cochrane Library, Web of Science, and Google Scholar. Guidelines, trial registries, and gray literature were also searched. Databases were searched from inception to January 20, 2022. STUDY ELIGIBILITY CRITERIA: Randomized controlled trials and controlled nonrandomized studies were eligible if they assessed interventions aimed at encouraging awareness of fetal movement or fetal movement counting and/or improving the subsequent clinical management of reduced fetal movement. Eligible populations were singleton pregnancies after 24 completed weeks of gestation. The primary review outcome was stillbirth; a number of secondary maternal and neonatal outcomes were specified in the review. METHODS: Risk of bias was assessed using the Cochrane Risk of Bias 2 and Risk of Bias in Non-Randomized Studies I tools for randomized controlled trials and nonrandomized studies, respectively. Variation caused by heterogeneity was assessed using I2. Data from studies employing similar interventions were combined using random effects meta-analysis. RESULTS: A total of 1609 citations were identified; 190 full-text articles were evaluated against the inclusion criteria, 18 studies (16 randomized controlled trials and 2 nonrandomized studies) were included. The evidence is uncertain about the effect of encouraging awareness of fetal movement on stillbirth when compared with standard care (2 studies, n=330,084) with a pooled adjusted odds ratio of 1.19 (95% confidence interval, 0.96-1.47). Interventions for encouraging awareness of fetal movement may be associated with a reduction in neonatal intensive care unit admissions and Apgar scores of <7 at 5 minutes of age and may not be associated with increases in cesarean deliveries or induction of labor. The evidence is uncertain about the effect of encouraging fetal movement counting on stillbirth when compared with standard care with a pooled odds ratio of 0.69 (95% confidence interval, 0.18-2.65) based on data from 3 randomized controlled trials (n=70,584). Counting fetal movements may increase maternal-fetal attachment and decrease anxiety when compared with standard care. When comparing combined interventions of fetal movement awareness and subsequent clinical management with standard care (1 study, n=393,857), the evidence is uncertain about the effect on stillbirth (adjusted odds ratio, 0.86; 95% confidence interval, 0.70-1.05). CONCLUSION: The effect of interventions for encouraging awareness of reduced fetal movement alone or in combination with subsequent clinical management on stillbirth is uncertain. Encouraging awareness of fetal movement may be associated with reduced adverse neonatal outcomes without an increase in interventions in labor. The meta-analysis was hampered by variations in interventions, outcome reporting, and definitions. Individual studies are frequently underpowered to detect a reduction in severe, rare outcomes and no studies were included from high-burden settings. Studies from such settings are needed to determine whether interventions can reduce stillbirth.

Rapid evidence synthesis to enable innovation and adoption in health and social care.

BACKGROUND: The rapid identification and adoption of effective innovations in healthcare is a known challenge. The strongest evidence base for innovations can be provided by evidence synthesis, but this is frequently a lengthy process and even rapid versions of this can be time-consuming and complex. In the UK, the Accelerated Access Review and Academic Health Science Network (AHSN) have provided the impetus to develop a consistently rapid process to support the identification and adoption of high-value innovations in the English NHS. METHODS: The Greater Manchester Applied Research Collaboration (ARC-GM) developed a framework for a rapid evidence synthesis (RES) approach, which is highly integrated within the innovation process of the Greater Manchester AHSN and the associated healthcare and research ecosystem. The RES uses evidence synthesis approaches and draws on the GRADE Evidence to Decision framework to provide rapid assessments of the existing evidence and its relevance to specific decision problems. We implemented this in a real-time context of decision-making around adoption of innovative health technologies. RESULTS: Key stakeholders in the Greater Manchester decision-making process for healthcare innovations have found that our approach is both timely and flexible; it is valued for its combination of rigour and speed. Our RES approach rapidly and systematically identifies, appraises and contextualises relevant evidence, which can then be transparently incorporated into decisions about the wider adoption of innovations. The RES also identifies limitations in existing evidence for innovations and this can inform subsequent evaluations. There is substantial interest from other ARCs and AHSNs in implementing a similar process. We are currently exploring methods to make completed RES publicly available. We are also exploring methods to evaluate the impact of using RES as more implementation decisions are made. CONCLUSIONS: The RES framework we have implemented combines transparency and consistency with flexibility and rapidity. It therefore maximises utility in a real-time decision-making context for healthcare innovations.

Reconstructive surgery for treating pressure ulcers.

BACKGROUND: There are several possible interventions for managing pressure ulcers (sometimes referred to as pressure injuries), ranging from pressure-relieving measures, such as repositioning, to reconstructive surgery. The surgical approach is usually reserved for recalcitrant wounds (where the healing process has stalled, or the wound is not responding to treatment) or wounds with full-thickness skin loss and exposure of deeper structures such as muscle fascia or bone. Reconstructive surgery commonly involves wound debridement followed by filling the wound with new tissue. Whilst this is an accepted means of ulcer management, the benefits and harms of different surgical approaches, compared with each other or with non-surgical treatments, are unclear. This is an update of a Cochrane Review published in 2016. OBJECTIVES: To assess the effects of different types of reconstructive surgery for treating pressure ulcers (category/stage II or above), compared with no surgery or alternative reconstructive surgical approaches, in any care setting. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was January 2022. SELECTION CRITERIA: Published or unpublished randomised controlled trials (RCTs) that assessed reconstructive surgery in the treatment of pressure ulcers. DATA COLLECTION AND ANALYSIS: Two review authors independently selected the studies, extracted study data, assessed the risk of bias and undertook GRADE assessments. We would have involved a third review author in case of disagreement. MAIN RESULTS: We identified one RCT conducted in a hospital setting in the USA. It enrolled 20 participants aged between 20 and 70 years with stage IV ischial or sacral pressure ulcers (involving full-thickness skin and tissue loss). The study compared two reconstructive techniques for stage IV pressure ulcers: conventional flap surgery and cone of pressure flap surgery, in which a large portion of the flap tip is de-epithelialised and deeply inset to obliterate dead space. There were no clear data for any of our outcomes, although we extracted some information on complete wound healing, wound dehiscence, pressure ulcer recurrence and wound infection. We graded the evidence for these outcomes as very low-certainty. The study provided no data for any other outcomes. AUTHORS' CONCLUSIONS: Currently there is very little randomised evidence on the role of reconstructive surgery in pressure ulcer management, although it is considered a priority area. More rigorous and robust research is needed to explore this intervention.

Evaluating a tool to improve engagement and recruitment of under-served groups in trials.

BACKGROUND: Despite substantial awareness that certain groups (e.g. ethnic minorities) are under-represented and under-served in trials, limited progress has been made in addressing this. As well as a public service and ethical duty to recruit and engage under-served groups in relevant research, importantly, there are clear scientific benefits, for example, increased generalisability. The key aims of the current study were to explore the following: general barriers and facilitators to enhancing the recruitment of under-served groups into trials, the usability and value of a specific tool (INCLUDE Ethnicity Framework) to support engagement and recruitment of under-served groups, and ways of engaging diverse patient, public and community involvement and engagement (PCIE) groups. METHODS: Firstly, researchers completed a brief survey in relation to a specific trial in which they were involved (N = 182, 38% response rate). A second stage involved sampling survey respondents and asking them to complete the INCLUDE Ethnicity Framework and then a remote semi-structured interview (N = 15). Qualitative data were analysed using thematic analysis. Finally, we conducted a consultation process with PCIE contributors primarily to develop guidelines for discussing the INCLUDE Ethnicity Framework with PCIE representatives. RESULTS: Researchers recognised the importance of increasing engagement and recruitment of under-served groups within trials, but varied in their knowledge, ability and commitment to implementation in practice. The INCLUDE Ethnicity Framework was described by some as raising their awareness of how inclusion could be improved. Respondents highlighted a need for shared resources and wider structural change to facilitate such engagement. PCIE was identified, in the survey and interviews, as the most common method of trying to improve recruitment of under-served groups. However, researchers also commonly highlighted that PCIE groups were sometimes not very diverse. CONCLUSIONS: There is a need for researchers to consider the funding and time resources required for diverse and inclusive recruitment to trials and for funders to enable this. The INCLUDE Ethnicity Framework can help to raise awareness of inclusion challenges. This study indicates that it is important to take proactive steps to involve relevant under-served groups in PCIE and practical suggestions are made to facilitate this.

Evidence assessing the development, evaluation and implementation of digital health technologies in wound care: A rapid scoping review.

OBJECTIVE: To scope published data on the development, evaluation and implementation of digital health technologies for use in wound care. We focused on digital health technologies that supported one or more of the following functions: system level (such as electronic health records, management systems), wound imaging and measurement, and communication. METHODS: For this rapid scoping review, Ovid MEDLINE and Ovid Embase were searched in January 2021 and relevant experts were consulted. We identified English language publications that reported the development, evaluation, and/or implementation of relevant digital health technologies. Studies were screened and data extracted and coded following the established scoping review methodology. Data were presented narratively, and in tabular formats. RESULTS: We included 156 studies in the review. After reported technologies were categorised based on their predominant function, 51 (32.7%) studies reported on system level technologies; 123 (78.8%) on wound imaging and measurement technologies; and 34 (21.8%) on communication-focused technologies such as video-conferencing technologies, messaging technologies). Of the 156 studies, 37 (23.7%) reported data on development of the technology; 135 (86.5%) reported evaluation activities, mainly for wound imaging and measurement technologies; and 2 (1.3%) reported implementation research. CONCLUSION: There is increasing focus on digital health technologies in wound care. Assessment of digital health technologies aimed at wound care has mainly been for those with a primary function around wound imaging and measurement. Most studies reported evaluation whilst evidence suggests the field may lack transparent reporting of technology development and implementation activities that could aid further decision-making.

The accuracy of pulse oximetry in measuring oxygen saturation by levels of skin pigmentation: a systematic review and meta-analysis.

BACKGROUND: During the COVID-19 pandemic, there have been concerns regarding potential bias in pulse oximetry measurements for people with high levels of skin pigmentation. We systematically reviewed the effects of skin pigmentation on the accuracy of oxygen saturation measurement by pulse oximetry (SpO2) compared with the gold standard SaO2 measured by CO-oximetry. METHODS: We searched Ovid MEDLINE, Ovid Embase, EBSCO CINAHL, ClinicalTrials.gov, and WHO International Clinical Trials Registry Platform (up to December 2021) for studies with SpO2-SaO2 comparisons and measuring the impact of skin pigmentation or ethnicity on pulse oximetry accuracy. We performed meta-analyses for mean bias (the primary outcome in this review) and its standard deviations (SDs) across studies included for each subgroup of skin pigmentation and ethnicity and used these pooled mean biases and SDs to calculate accuracy root-mean-square (Arms) and 95% limits of agreement. The review was registered with the Open Science Framework ( https://osf.io/gm7ty ). RESULTS: We included 32 studies (6505 participants): 15 measured skin pigmentation and 22 referred to ethnicity. Compared with standard SaO2 measurement, pulse oximetry probably overestimates oxygen saturation in people with the high level of skin pigmentation (pooled mean bias 1.11%; 95% confidence interval 0.29 to 1.93%) and people described as Black/African American (1.52%; 0.95 to 2.09%) (moderate- and low-certainty evidence). The bias of pulse oximetry measurements for people with other levels of skin pigmentation or those from other ethnic groups is either more uncertain or suggests no overestimation. Whilst the extent of mean bias is small or negligible for all subgroups evaluated, the associated imprecision is unacceptably large (pooled SDs > 1%). When the extent of measurement bias and precision is considered jointly, pulse oximetry measurements for all the subgroups appear acceptably accurate (with Arms < 4%). CONCLUSIONS: Pulse oximetry may overestimate oxygen saturation in people with high levels of skin pigmentation and people whose ethnicity is reported as Black/African American, compared with SaO2. The extent of overestimation may be small in hospital settings but unknown in community settings. REVIEW PROTOCOL REGISTRATION: https://osf.io/gm7ty.

Postoperative Packing of Perianal Abscess Cavities (PPAC2): randomized clinical trial.

BACKGROUND: Perianal abscess is common. Traditionally, postoperative perianal abscess cavities are managed with internal wound packing, a practice not supported by evidence. The aim of this randomized clinical trial (RCT) was to assess if non-packing is less painful and if it is associated with adverse outcomes. METHODS: The Postoperative Packing of Perianal Abscess Cavities (PPAC2) trial was a multicentre, RCT (two-group parallel design) of adult participants admitted to an NHS hospital for incision and drainage of a primary perianal abscess. Participants were randomized 1:1 (via an online system) to receive continued postoperative wound packing or non-packing. Blinded data were collected via symptom diaries, telephone, and clinics over 6 months. The objective was to determine whether non-packing of perianal abscess cavities is less painful than packing, without an increase in perianal fistula or abscess recurrence. The primary outcome was pain (mean maximum pain score on a 100-point visual analogue scale). RESULTS: Between February 2018 and March 2020, 433 participants (mean age 42 years) were randomized across 50 sites. Two hundred and thirteen participants allocated to packing reported higher pain scores than 220 allocated to non-packing (38.2 versus 28.2, mean difference 9.9; P < 0.0001). The occurrence of fistula-in-ano was low in both groups: 32/213 (15 per cent) in the packing group and 24/220 (11 per cent) in the non-packing group (OR 0.69, 95 per cent c.i. 0.39 to 1.22; P = 0.20). The proportion of patients with abscess recurrence was also low: 13/223 (6 per cent) in the non-packing group and 7/213 (3 per cent) in the packing group (OR 1.85, 95 per cent c.i. 0.72 to 4.73; P = 0.20). CONCLUSION: Avoiding abscess cavity packing is less painful without a negative morbidity risk. REGISTRATION NUMBER: ISRCTN93273484 (https://www.isrctn.com/ISRCTN93273484). REGISTRATION NUMBER: NCT03315169 (http://clinicaltrials.gov).

Perianal abscess is a common, painful condition due to infection and swelling around the anus caused by blockage of the anal glands. The treatment of perianal abscess has stayed the same for over 50 years. An operation is performed under general anaesthetic to cut the skin and drain the infection. This is followed by continued internal dressing (packing) of the remaining cavity (hole) until the skin has healed over. Packing changes are needed multiple times a week for several weeks. Packing is the accepted treatment as it is believed to reduce the chance of the abscess coming back, and also reduces the chance of perianal fistula forming. There are no medical studies to support this idea. Perianal fistula (an abnormal passage between the skin around the anus, and the inside of the anal canal or rectum) is a long-term condition, which causes pain, and pus (and sometimes faeces) discharge, and often needs another operation (or multiple operations) to fix it. This trial was performed to demonstrate if no packing of a perianal abscess would result in a reduction of pain, with no increase in unwanted abscess recurrences and fistulas, in comparison to the standard treatment of packing. The trial recruited 433 people, who were randomly chosen to enter one of two groups; one to have their wound packed and the other to have no packing of the wound. After being discharged from hospital following surgery, the patients attended or were visited by a community nurse for the dressing to be changed or wound packed. Each patient provided information on pain from their wound, including worst pain each day and pain before, during, and after the changing of their dressing or packing. This and other information was gathered for the first 10 days after surgery and periodically until 6 months after surgery. The no-packing group experienced much less pain than the packing group. There was no difference in abscess recurrence and fistula formation between the non-packing and packing groups. The findings demonstrate that no packing of perianal abscess wounds after drainage operation is the best treatment.

What promotes or prevents greater use of appropriate compression in people with venous leg ulcers? A qualitative interview study with nurses in the north of England using the Theoretical Domains Framework.

OBJECTIVES: To investigate factors that promote and prevent the use of compression therapy in people with venous leg ulcers. DESIGN: Qualitative interview study with nurses using the Theoretical Domains Framework (TDF). SETTING: Three National Health Service Trusts in England. PARTICIPANTS: Purposive sample of 15 nurses delivering wound care. RESULTS: Nurses described factors which made provision of compression therapy challenging. Organisational barriers (TDF domains environmental context and resources/knowledge, skills/behavioural regulation) included heavy/increasing caseloads; lack of knowledge/skills and the provision of training; and prescribing issues (variations in bandaging systems/whether nurses could prescribe). Absence of specialist leg ulcer services to refer patients into was perceived as a barrier to providing optimal care by some community-based nurses. Compression use was perceived to be facilitated by clinics for timely initial assessment; continuity of staff and good liaison between vascular/leg ulcer clinics and community teams; clear local policies and care pathways; and opportunities for training such as 'shadowing' in vascular/leg ulcer clinics. Patient engagement barriers (TDF domains goals/beliefs about consequences) focused on getting patients 'on board' with compression, and supporting them in using it. Clear explanations were seen as key in promoting compression use. CONCLUSIONS: Rising workload pressures present significant challenges to enhancing leg ulcer services. There may be opportunities to develop facilitated approaches to enable community nursing teams to make changes to practice, enhancing quality of patient care. The majority of venous leg ulcers could be managed in the community without referral to specialist community services if issues relating to workloads/skills/training are addressed. Barriers to promoting compression use could also be targeted, for example, through the development of clear patient information leaflets. While the patient engagement barriers may be easier/quicker to address than organisational barriers, unless organisational barriers are addressed it seems unlikely that all people who would benefit from compression therapy will receive it.

Negative pressure wound therapy for surgical wounds healing by primary closure.

BACKGROUND: Indications for the use of negative pressure wound therapy (NPWT) are broad and include prophylaxis for surgical site infections (SSIs). Existing evidence for the effectiveness of NPWT on postoperative wounds healing by primary closure remains uncertain. OBJECTIVES: To assess the effects of NPWT for preventing SSI in wounds healing through primary closure, and to assess the cost-effectiveness of NPWT in wounds healing through primary closure. SEARCH METHODS: In January 2021, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries and references of included studies, systematic reviews and health technology reports. There were no restrictions on language, publication date or study setting. SELECTION CRITERIA: We included trials if they allocated participants to treatment randomly and compared NPWT with any other type of wound dressing, or compared one type of NPWT with another. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed trials using predetermined inclusion criteria. We carried out data extraction, assessment using the Cochrane risk of bias tool, and quality assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology. Our primary outcomes were SSI, mortality, and wound dehiscence. MAIN RESULTS: In this fourth update, we added 18 new randomised controlled trials (RCTs) and one new economic study, resulting in a total of 62 RCTs (13,340 included participants) and six economic studies. Studies evaluated NPWT in a wide range of surgeries, including orthopaedic, obstetric, vascular and general procedures. All studies compared NPWT with standard dressings. Most studies had unclear or high risk of bias for at least one key domain. Primary outcomes Eleven studies (6384 participants) which reported mortality were pooled. There is low-certainty evidence showing there may be a reduced risk of death after surgery for people treated with NPWT (0.84%) compared with standard dressings (1.17%) but there is uncertainty around this as confidence intervals include risk of benefits and harm; risk ratio (RR) 0.78 (95% CI 0.47 to 1.30; I2 = 0%). Fifty-four studies reported SSI; 44 studies (11,403 participants) were pooled. There is moderate-certainty evidence that NPWT probably results in fewer SSIs (8.7% of participants) than treatment with standard dressings (11.75%) after surgery; RR 0.73 (95% CI 0.63 to 0.85; I2 = 29%). Thirty studies reported wound dehiscence; 23 studies (8724 participants) were pooled. There is moderate-certainty evidence that there is probably little or no difference in dehiscence between people treated with NPWT (6.62%) and those treated with standard dressing (6.97%), although there is imprecision around the estimate that includes risk of benefit and harms; RR 0.97 (95% CI 0.82 to 1.16; I2 = 4%). Evidence was downgraded for imprecision, risk of bias, or a combination of these. Secondary outcomes There is low-certainty evidence for the outcomes of reoperation and seroma; in each case, confidence intervals included both benefit and harm. There may be a reduced risk of reoperation favouring the standard dressing arm, but this was imprecise: RR 1.13 (95% CI 0.91 to 1.41; I2 = 2%; 18 trials; 6272 participants). There may be a reduced risk of seroma for people treated with NPWT but this is imprecise: the RR was 0.82 (95% CI 0.65 to 1.05; I2 = 0%; 15 trials; 5436 participants). For skin blisters, there is low-certainty evidence that people treated with NPWT may be more likely to develop skin blisters compared with those treated with standard dressing (RR 3.55; 95% CI 1.43 to 8.77; I2 = 74%; 11 trials; 5015 participants). The effect of NPWT on haematoma is uncertain (RR 0.79; 95 % CI 0.48 to 1.30; I2 = 0%; 17 trials; 5909 participants; very low-certainty evidence). There is low-certainty evidence of little to no difference in reported pain between groups. Pain was measured in different ways and most studies could not be pooled; this GRADE assessment is based on all fourteen trials reporting pain; the pooled RR for the proportion of participants who experienced pain was 1.52 (95% CI 0.20, 11.31; I2 = 34%; two studies; 632 participants). Cost-effectiveness Six economic studies, based wholly or partially on trials in our review, assessed the cost-effectiveness of NPWT compared with standard care. They considered NPWT in five indications: caesarean sections in obese women; surgery for lower limb fracture; knee/hip arthroplasty; coronary artery bypass grafts; and vascular surgery with inguinal incisions. They calculated quality-adjusted life-years or an equivalent, and produced estimates of the treatments' relative cost-effectiveness. The reporting quality was good but the evidence certainty varied from moderate to very low. There is moderate-certainty evidence that NPWT in surgery for lower limb fracture was not cost-effective at any threshold of willingness-to-pay and that NPWT is probably cost-effective in obese women undergoing caesarean section. Other studies found low or very low-certainty evidence indicating that NPWT may be cost-effective for the indications assessed. AUTHORS' CONCLUSIONS: People with primary closure of their surgical wound and treated prophylactically with NPWT following surgery probably experience fewer SSIs  than people treated with standard dressings but there is probably no difference in wound dehiscence (moderate-certainty evidence). There may be a reduced risk of death after surgery for people treated with NPWT compared with standard dressings but there is uncertainty around this as confidence intervals include risk of benefit and harm (low-certainty evidence). People treated with NPWT may experience more instances of skin blistering compared with standard dressing treatment (low-certainty evidence). There are no clear differences in other secondary outcomes where most evidence is low or very low-certainty. Assessments of cost-effectiveness of NPWT produced differing results in different indications. There is a large number of ongoing studies, the results of which may change the findings of this review. Decisions about use of NPWT should take into account surgical indication and setting and consider evidence for all outcomes.

Wound fluid sampling methods for proteomic studies: A scoping review.

Understanding why some wounds are hard to heal is important for improving care and developing more effective treatments. The method of sample collection used is an integral step in the research process and thus may affect the results obtained. The primary objective of this study was to summarise and map the methods currently used to sample wound fluid for protein profiling and analysis. Eligible studies were those that used a sampling method to collect wound fluid from any human wound for analysis of proteins. A search for eligible studies was performed using MEDLINE, Embase and CINAHL Plus in May 2020. All references were screened for eligibility by one reviewer, followed by discussion and consensus with a second reviewer. Quantitative data were mapped and visualised using appropriate software and summarised via a narrative summary. After screening, 280 studies were included in this review. The most commonly used group of wound fluid collection methods were vacuum, drainage or use of other external devices, with surgical wounds being the most common sample source. Other frequently used collection methods were extraction from absorbent materials, collection beneath an occlusive dressing and direct collection of wound fluid. This scoping review highlights the variety of methods used for wound fluid collection. Many studies had small sample sizes and short sample collection periods; these weaknesses have hampered the discovery and validation of novel biomarkers. Future research should aim to assess the reproducibility and feasibility of sampling and analytical methods for use in larger longitudinal studies.

Pressure redistributing static chairs for preventing pressure ulcers.

BACKGROUND: Sitting can be viewed as a therapeutic intervention and an important part of a person's recovery process; but the risk of ulceration must be mitigated. Interventions for ulcer prevention in those at risk from prolonged sitting include the use of specialist cushions and surfaces, especially for wheelchair users. Whilst there is interest in the effects of different pressure redistributing cushions for wheelchairs, the benefits of pressure redistributing static chairs, compared with standard chairs, for pressure ulcer development in at-risk people are not clear. OBJECTIVES: To assess the effects of pressure redistributing static chairs on the prevention of pressure ulcers in health, rehabilitation and social care settings, and places of residence in which people may spend their day. SEARCH METHODS: In June 2021 we searched the following electronic databases to identify reports of relevant randomised clinical trials: the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Ovid Embase and EBSCO CINAHL Plus (Cumulative Index to Nursing and Allied Health Literature). We also searched clinical trials registers for ongoing and unpublished studies, and reference lists of relevant systematic reviews, meta-analyses and health technology reports. There were no restrictions by language, date of publication or study setting. SELECTION CRITERIA: We sought to include published or unpublished randomised controlled trials that assessed pressure redistributing static chairs in the prevention or management of pressure ulcers. DATA COLLECTION AND ANALYSIS: Two review authors independently performed study selection. We planned that two review authors would also assess the risk of bias, extract study data and assess the certainty of evidence according to GRADE methodology. MAIN RESULTS: We did not identify any studies that met the review eligibility criteria, nor any registered studies investigating the role of pressure redistributing static chairs in the prevention or management of pressure ulcers. AUTHORS' CONCLUSIONS: Currently, there is no randomised evidence that supports or refutes the role of pressure redistributing static chairs in the prevention or management of pressure ulcers. This is a priority area and there is a need to explore this intervention with rigorous and robust research.

Variation in appropriate diabetes care and treatment targets in urban and rural areas in England: an observational study of the 'rule of halves'.

OBJECTIVES: To estimate the 'rule of halves' for diabetes care for urban and rural areas in England using several data sources covering the period 2015-2017; and to examine the extent to which any differences in urban and rural settings are explained by population characteristics and the workforce supply of primary care providers (general practices). DESIGN: A retrospective observational study. SETTING: Populations resident in predominantly urban and rural areas in England (2015-2017). PARTICIPANTS: N=33 336 respondents to the UK Household Longitudinal Survey in urban and rural settings in England; N=4913 general practices in England reporting to the National Diabetes Audit and providing workforce data to NHS Digital. OUTCOMES: Diabetes prevalence; administrative records of diagnoses of diabetes; provision of (all eight) recommended diabetes care processes; diabetes treatment targets. RESULTS: Diabetes prevalence was higher in urban areas in England (7.80% (95% CI 7.30% to 8.31%)) relative to rural areas (7.24% (95% CI 6.32% to 8.16%)). For practices in urban areas, relatively fewer cases of diabetes were recorded in administrative medical records (69.55% vs 71.86%), and a smaller percentage of those registered received the appropriate care (45.85% vs 49.32%). Among estimated prevalent cases of diabetes, urban areas have a 24.84% achieving these targets compared with 25.16% in rural areas. However, adjusted analyses showed that the performance of practices in urban areas in providing appropriate care quality was not significantly different from practices in rural areas. CONCLUSIONS: The 'rule of halves' is not an accurate description of the actual pattern across the diabetes care pathway in England. More than half of the estimated urban and rural diabetes population are registered with clinical practices and have access to treatment. However, less than half of those registered for treatment have achieved treatment targets. Appropriate care quality was associated with a greater proportion of patients with diabetes achieving treatment targets.

Health service costs of treating venous leg ulcers in the UK: evidence from a cross-sectional survey based in the north west of England.

OBJECTIVES: To estimate and examine the direct healthcare costs of treating people with open venous leg ulcers in the UK. DESIGN: Cost-of-illness study. SETTING: A cross-sectional survey of nine National Health Service community locales over 2-week periods in 2015/2016. METHODS: We examined the resource use and prevalence of venous leg ulcer treatment in the community. Examination of variation in these obtained costs was performed by ordinary least squares regression. We used additional resource use information from a randomised control trial and extrapolated costs to the UK for an annual period. RESULTS: The average 2-week per person cost of treating patients where a venous leg ulceration was the primary (most severe) wound was estimated at £166.39 (95% CI £157.78 to £175.00) with community staff time making up over half of this amount. Costs were higher where antimicrobial dressings were used and where wound care was delivered in the home. Among those with any recorded venous leg ulcer (primary and non-primary), we derived a point prevalence of 3.2 per 10 000 population and estimated that the annual prevalence could be no greater than 82.4 per 10 000 population. We estimated that the national cost of treating a venous leg ulcer was £102 million with a per person annual cost at £4787.70. CONCLUSION: Our point prevalence figures are in line with the literature. However, our annual prevalence estimations and costs are far lower than those reported in recent literature which suggests that the costs of treating venous leg ulcers are lower than previously thought. Movement towards routinely collected and useable community care activity would help provide a transparent and deeper understanding of the scale and cost of wound care in the UK.

Establishment of a core outcome set for burn care research: development and international consensus.

Objective: To develop a core outcome set for international burn research. Design: Development and international consensus, from April 2017 to November 2019. Methods: Candidate outcomes were identified from systematic reviews and stakeholder interviews. Through a Delphi survey, international clinicians, researchers, and UK patients prioritised outcomes. Anonymised feedback aimed to achieve consensus. Pre-defined criteria for retaining outcomes were agreed. A consensus meeting with voting was held to finalise the core outcome set. Results: Data source examination identified 1021 unique outcomes grouped into 88 candidate outcomes. Stakeholders in round 1 of the survey, included 668 health professionals from 77 countries (18% from low or low middle income countries) and 126 UK patients or carers. After round 1, one outcome was discarded, and 13 new outcomes added. After round 2, 69 items were discarded, leaving 31 outcomes for the consensus meeting. Outcome merging and voting, in two rounds, with prespecified thresholds agreed seven core outcomes: death, specified complications, ability to do daily tasks, wound healing, neuropathic pain and itch, psychological wellbeing, and return to school or work. Conclusions: This core outcome set caters for global burn research, and future trials are recommended to include measures of these outcomes.