A core outcome set for trials evaluating self-management interventions in people with severe mental illness and coexisting type 2 diabetes.

BACKGROUND: People with severe mental illness (SMI), such as schizophrenia, have higher rates of type 2 diabetes and worse outcomes, compared to those without SMI and it is not known whether diabetes self-management interventions are effective for people who have both conditions. Research in this area has been impeded by a lack of consensus on which outcomes to prioritise in people with co-existing SMI and diabetes. AIMS: To develop a core outcome set (COS) for use in effectiveness trials of diabetes self-management interventions in adults with both type 2 diabetes and SMI. METHODS: The COS was developed in three stages: (i) identification of outcomes from systematic literature review of intervention studies, followed by multi-stakeholder and service user workshops; (ii) rating of outcomes in a two-round online Delphi survey; (iii) agreement of final 'core' outcomes through a stakeholder consensus workshop. RESULTS: Seven outcomes were selected: glucose control, blood pressure, body composition (body weight, BMI, body fat), health-related quality of life, diabetes self-management, diabetes-related distress and medication adherence. CONCLUSIONS: This COS is recommended for future trials of effectiveness of diabetes self-management interventions for people with SMI and type 2 diabetes. Its use will ensure trials capture important outcomes and reduce heterogeneity so findings can be readily synthesised to inform practice and policy.

Interventions to address unprofessional behaviours between staff in acute care: what works for whom and why? A realist review.

BACKGROUND: Unprofessional behaviour (UB) between staff encompasses various behaviours, including incivility, microaggressions, harassment, and bullying. UB is pervasive in acute healthcare settings and disproportionately impacts minoritised staff. UB has detrimental effects on staff wellbeing, patient safety and organisational resources. While interventions have been implemented to mitigate UB, there is limited understanding of how and why they may work and for whom. METHODS: This study utilised a realist review methodology with stakeholder input to improve understanding of these complex context-dependent interventions. Initial programme theories were formulated drawing upon scoping searches and reports known to the study team. Purposive systematic searches were conducted to gather grey and published global literature from databases. Documents were selected if relevant to UB in acute care settings while considering rigour and relevance. Data were extracted from these reports, synthesised, and initial theories tested, to produce refined programme theories. RESULTS: Of 2977 deduplicated records, 148 full text reports were included with 42 reports describing interventions to address UB in acute healthcare settings. Interventions drew on 13 types of behaviour change strategies and were categorised into five types of intervention (1) single session (i.e. one off); (2) multiple session; (3) single or multiple sessions combined with other actions (e.g. training sessions plus a code of conduct); (4) professional accountability and reporting programmes and; (5) structured culture change interventions. We formulated 55 context-mechanism-outcome configurations to explain how, why, and when these interventions work. We identified twelve key dynamics to consider in intervention design, including importance of addressing systemic contributors, rebuilding trust in managers, and promoting a psychologically safe culture; fifteen implementation principles were identified to address these dynamics. CONCLUSIONS: Interventions to address UB are still at an early stage of development, and their effectiveness to reduce UB and improve patient safety is unclear. Future interventions should incorporate knowledge from behavioural and implementation science to affect behaviour change; draw on multiple concurrent strategies to address systemic contributors to UB; and consider the undue burden of UB on minoritised groups. STUDY REGISTRATION: This study was registered on the international database of prospectively registered systematic reviews in health and social care (PROSPERO): https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021255490 .

Exploring variation in implementation of multifactorial falls risk assessment and tailored interventions: a realist review.

BACKGROUND: Falls are the most common safety incident reported by acute hospitals. In England national guidance recommends delivery of a multifactorial falls risk assessment (MFRA) and interventions tailored to address individual falls risk factors. However, there is variation in how these practices are implemented. This study aimed to explore the variation by examining what supports or constrains delivery of MFRAs and tailored interventions in acute hospitals. METHODS: A realist review of literature was conducted with searches completed in three stages: (1) to construct hypotheses in the form of Context, Mechanism, Outcome configurations (CMOc) about how MFRAs and interventions are delivered, (2) to scope the breadth and depth of evidence available in Embase to test the CMOcs, and (3) following prioritisation of CMOcs, to refine search strategies for use in multiple databases. Citations were managed in EndNote; titles, abstracts, and full texts were screened, with 10% independently screened by two reviewers. RESULTS: Two CMOcs were prioritised for testing labelled: Facilitation via MFRA tools, and Patient Participation in interventions. Analysis indicated that MFRA tools can prompt action, but the number and type of falls risk factors included in tools differ across organisations leading to variation in practice. Furthermore, the extent to which tools work as prompts is influenced by complex ward conditions such as changes in patient condition, bed swaps, and availability of falls prevention interventions. Patient participation in falls prevention interventions is more likely where patient directed messaging takes individual circumstances into account, e.g., not wanting to disturb nurses by using the call bell. However, interactions that elicit individual circumstances can be resource intensive and patients with cognitive impairment may not be able to participate despite appropriately directed messaging. CONCLUSIONS: Organisations should consider how tools can be developed in ways that better support consistent and comprehensive identification of patients' individual falls risk factors and the complex ward conditions that can disrupt how tools work as facilitators. Ward staff should be supported to deliver patient directed messaging that is informed by their individual circumstances to encourage participation in falls prevention interventions, where appropriate. TRIAL REGISTRATION: PROSPERO: CRD42020184458.

Drivers of unprofessional behaviour between staff in acute care hospitals: a realist review.

BACKGROUND: Unprofessional behaviours (UB) between healthcare staff are rife in global healthcare systems, negatively impacting staff wellbeing, patient safety and care quality. Drivers of UBs include organisational, situational, team, and leadership issues which interact in complex ways. An improved understanding of these factors and their interactions would enable future interventions to better target these drivers of UB. METHODS: A realist review following RAMESES guidelines was undertaken with stakeholder input. Initial theories were formulated drawing on reports known to the study team and scoping searches. A systematic search of databases including Embase, CINAHL, MEDLINE and HMIC was performed to identify literature for theory refinement. Data were extracted from these reports, synthesised, and initial theories tested, to produce refined programme theories. RESULTS: We included 81 reports (papers) from 2,977 deduplicated records of grey and academic reports, and 28 via Google, stakeholders, and team members, yielding a total of 109 reports. Five categories of contributor were formulated: (1) workplace disempowerment; (2) harmful workplace processes and cultures; (3) inhibited social cohesion; (4) reduced ability to speak up; and (5) lack of manager awareness and urgency. These resulted in direct increases to UB, reduced ability of staff to cope, and reduced ability to report, challenge or address UB. Twenty-three theories were developed to explain how these contributors work and interact, and how their outcomes differ across diverse staff groups. Staff most at risk of UB include women, new staff, staff with disabilities, and staff from minoritised groups. UB negatively impacted patient safety by impairing concentration, communication, ability to learn, confidence, and interpersonal trust. CONCLUSION: Existing research has focused primarily on individual characteristics, but these are inconsistent, difficult to address, and can be used to deflect organisational responsibility. We present a comprehensive programme theory furthering understanding of contributors to UB, how they work and why, how they interact, whom they affect, and how patient safety is impacted. More research is needed to understand how and why minoritised staff are disproportionately affected by UB. STUDY REGISTRATION: This study was registered on the international database of prospectively registered systematic reviews in health and social care (PROSPERO): https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021255490 .

What Works Where and How for Uptake and Impact of Artificial Intelligence in Pathology: Review of Theories for a Realist Evaluation.

BACKGROUND: There is increasing interest in the use of artificial intelligence (AI) in pathology to increase accuracy and efficiency. To date, studies of clinicians' perceptions of AI have found only moderate acceptability, suggesting the need for further research regarding how to integrate it into clinical practice. OBJECTIVE: The aim of the study was to determine contextual factors that may support or constrain the uptake of AI in pathology. METHODS: To go beyond a simple listing of barriers and facilitators, we drew on the approach of realist evaluation and undertook a review of the literature to elicit stakeholders' theories of how, for whom, and in what circumstances AI can provide benefit in pathology. Searches were designed by an information specialist and peer-reviewed by a second information specialist. Searches were run on the arXiv.org repository, MEDLINE, and the Health Management Information Consortium, with additional searches undertaken on a range of websites to identify gray literature. In line with a realist approach, we also made use of relevant theory. Included documents were indexed in NVivo 12, using codes to capture different contexts, mechanisms, and outcomes that could affect the introduction of AI in pathology. Coded data were used to produce narrative summaries of each of the identified contexts, mechanisms, and outcomes, which were then translated into theories in the form of context-mechanism-outcome configurations. RESULTS: A total of 101 relevant documents were identified. Our analysis indicates that the benefits that can be achieved will vary according to the size and nature of the pathology department's workload and the extent to which pathologists work collaboratively; the major perceived benefit for specialist centers is in reducing workload. For uptake of AI, pathologists' trust is essential. Existing theories suggest that if pathologists are able to "make sense" of AI, engage in the adoption process, receive support in adapting their work processes, and can identify potential benefits to its introduction, it is more likely to be accepted. CONCLUSIONS: For uptake of AI in pathology, for all but the most simple quantitative tasks, measures will be required that either increase confidence in the system or provide users with an understanding of the performance of the system. For specialist centers, efforts should focus on reducing workload rather than increasing accuracy. Designers also need to give careful thought to usability and how AI is integrated into pathologists' workflow.

Effectiveness and implementation of psychological interventions for depression in people with non-communicable diseases in South Asia: Systematic review and meta-analysis.

We evaluate the effectiveness of psychological interventions for depression in people with NCDs in South Asia and explore the individual, organizational, and policy-level barriers and facilitators for the implementation and scaling up of these interventions. Eight databases (and local web pages) were searched in May 2022. We conducted random effects models to evaluate the pooled effect of psychological interventions on depression in people with NCDs. We extracted the individual, organizational, and policy level barriers and facilitators. We found five randomized control trials, nine qualitative studies, and 35 policy documents that fitted the inclusion criteria. The pooled standardized mean difference in depression comparing psychological interventions with usual care was -2.31 (95% CI, -4.16 to -0.45; p = .015, I2 = 96.0%). We found barriers and facilitators to intervention delivery, mental health appears in the policy agenda in Bangladesh and Pakistan. However, there is a lack of policies relating to training in mental health for NCD health providers and a lack of integration of mental health care with NCD care. All of the psychological interventions reported to be effective in treating depression in this population. There are important delivery and policy barriers to the implementation and scaling up of psychological interventions for people with NCDs.

Incidence trends for twelve cancers in younger adults-a rapid review.

Many cancer referral guidelines use patient's age as a key criterium to decide who should be referred urgently. A recent rise in the incidence of colorectal cancer in younger adults has been described in high-income countries worldwide. Information on other cancers is more limited. The aim of this rapid review was to determine whether other cancers are also increasing in younger age groups, as this may have important implications for prioritising patients for investigation and referral. We searched MEDLINE, Embase and Web of Science for studies describing age-related incidence trends for colorectal, bladder, lung, oesophagus, pancreas, stomach, breast, ovarian, uterine, kidney and laryngeal cancer and myeloma. 'Younger' patients were defined based on NICE guidelines for cancer referral. Ninety-eight studies met the inclusion criteria. Findings show that the incidence of colorectal, breast, kidney, pancreas, uterine cancer is increasing in younger age groups, whilst the incidence of lung, laryngeal and bladder cancer is decreasing. Data for oesophageal, stomach, ovarian cancer and myeloma were inconclusive. Overall, this review provides evidence that some cancers are increasingly being diagnosed in younger age groups, although the mechanisms remain unclear. Cancer investigation and referral guidelines may need updating in light of these trends.

Attracting, recruiting and retaining nurses and care workers working in care homes: the need for a nuanced understanding informed by evidence and theory.

The care home sector relies on nurses and care workers to deliver care to residents living with frailty and complex needs. However, attracting, recruiting and retaining staff is one of the biggest challenges facing this sector. There is evidence available that describes factors that influence staff decisions to join and/or remain in the care home workforce, for example, individual rewards (such as feeling valued at work or training opportunities), relationships with colleagues and residents, supportive management or working arrangements (including flexible hours). However, it is less clear how different strategies are informed by evidence to improve recruitment and retention. Care homes are heterogeneous in terms of their size, staffing levels and mix, staff age groups, geographical location and working conditions. What matters to different members of the care home workforce will vary across nurses and care workers of different ages and levels of qualification or experience. Recognising this diversity is key: understanding how to attract, recruit and retain staff needs to discriminate and offer solutions that address this diversity. This important area of practice does not lend itself to a 'one-approach-fits-all' solution. This commentary provides a brief overview of known workforce challenges for the care home sector and argues for studies that use empirical evidence to test different theories of what might work for different staff, how and why, and in different circumstances.

Interventions for preventing type 2 diabetes in adults with mental disorders in low- and middle-income countries.

BACKGROUND: The prevalence of type 2 diabetes is increased in individuals with mental disorders. Much of the burden of disease falls on the populations of low- and middle-income countries (LMICs). OBJECTIVES: To assess the effects of pharmacological, behaviour change, and organisational interventions versus active and non-active comparators in the prevention or delay of type 2 diabetes among people with mental illness in LMICs. SEARCH METHODS: We searched the Cochrane Common Mental Disorders Controlled Trials Register, CENTRAL, MEDLINE, Embase and six other databases, as well as three international trials registries. We also searched conference proceedings and checked the reference lists of relevant systematic reviews. Searches are current up to 20 February 2020. SELECTION CRITERIA: Randomized controlled trials (RCTs) of pharmacological, behavioural or organisational interventions targeting the prevention or delay of type 2 diabetes in adults with mental disorders in LMICs. DATA COLLECTION AND ANALYSIS: Pairs of review authors working independently performed data extraction and risk of bias assessments. We conducted meta-analyses using random-effects models. MAIN RESULTS: One hospital-based RCT with 150 participants (99 participants with schizophrenia) addressed our review's primary outcome of prevention or delay of type 2 diabetes onset. Low-certainty evidence from this study did not show a difference between atypical and typical antipsychotics in the development of diabetes at six weeks (risk ratio (RR) 0.46, 95% confidence interval (CI) 0.03 to 7.05) (among a total 99 participants with schizophrenia, 68 were in atypical and 31 were in typical antipsychotic groups; 55 participants without mental illness were not considered in the analysis). An additional 29 RCTs with 2481 participants assessed one or more of the review's secondary outcomes. All studies were conducted in hospital settings and reported on pharmacological interventions. One study, which we could not include in our meta-analysis, included an intervention with pharmacological and behaviour change components. We identified no studies of organisational interventions. Low- to moderate-certainty evidence suggests there may be no difference between the use of atypical and typical antipsychotics for the outcomes of drop-outs from care (RR 1.31, 95% CI 0.63 to 2.69; two studies with 144 participants), and fasting blood glucose levels (mean difference (MD) 0.05 lower, 95% CI 0.10 to 0.00; two studies with 211 participants). Participants who receive typical antipsychotics may have a lower body mass index (BMI) at follow-up than participants who receive atypical antipsychotics (MD 0.57, 95% CI 0.33 to 0.81; two studies with 141 participants; moderate certainty of evidence), and may have lower total cholesterol levels eight weeks after starting treatment (MD 0.35, 95% CI 0.27 to 0.43; one study with 112 participants). There was moderate certainty evidence suggesting no difference between the use of metformin and placebo for the outcomes of drop-outs from care (RR 1.22, 95% CI 0.09 to 16.35; three studies with 158 participants). There was moderate-to-high certainty evidence of no difference between metformin and placebo for fasting blood glucose levels (endpoint data: MD -0.35, 95% CI -0.60 to -0.11; change from baseline data: MD 0.01, 95% CI -0.21 to 0.22; five studies with 264 participants). There was high certainty evidence that BMI was lower for participants receiving metformin compared with those receiving a placebo (MD -1.37, 95% CI -2.04 to -0.70; five studies with 264 participants; high certainty of evidence). There was no difference between metformin and placebo for the outcomes of waist circumference, blood pressure and cholesterol levels. Low-certainty evidence from one study (48 participants) suggests there may be no difference between the use of melatonin and placebo for the outcome of drop-outs from care (RR 1.00, 95% CI 0.38 to 2.66). Fasting blood glucose is probably reduced more in participants treated with melatonin compared with placebo (endpoint data: MD -0.17, 95% CI -0.35 to 0.01; change from baseline data: MD -0.24, 95% CI -0.39 to -0.09; three studies with 202 participants, moderate-certainty evidence). There was no difference between melatonin and placebo for the outcomes of waist circumference, blood pressure and cholesterol levels. Very low-certainty evidence from one study (25 participants) suggests that drop-outs may be higher in participants treated with a tricyclic antidepressant (TCA) compared with those receiving a selective serotonin reuptake inhibitor (SSRI) (RR 0.34, 95% CI 0.11 to 1.01). It is uncertain if there is no difference in fasting blood glucose levels between these groups (MD -0.39, 95% CI -0.88 to 0.10; three studies with 141 participants, moderate-certainty evidence). It is uncertain if there is no difference in BMI and depression between the TCA and SSRI antidepressant groups. AUTHORS' CONCLUSIONS: Only one study reported data on our primary outcome of interest, providing low-certainty evidence that there may be no difference in risk between atypical and typical antipsychotics for the outcome of developing type 2 diabetes. We are therefore not able to draw conclusions on the prevention of type 2 diabetes in people with mental disorders in LMICs. For studies reporting on secondary outcomes, there was evidence of risk of bias in the results. There is a need for further studies with participants from LMICs with mental disorders, particularly on behaviour change and on organisational interventions targeting prevention of type 2 diabetes in these populations.

Searching for Programme theories for a realist evaluation: a case study comparing an academic database search and a simple Google search.

BACKGROUND: Realist methodologies are increasingly being used to evaluate complex interventions in health and social care. Programme theory (ideas and assumptions of how a particular intervention works) development is the first step in a realist evaluation or a realist synthesis, with literature reviews providing important evidence to support this. Deciding how to search for programme theories is challenging and there is limited guidance available. Using an example of identifying programme theories for a realist evaluation of Pressure Ulcer Risk Assessment Instruments in clinical practice, the authors explore and compare several different approaches to literature searching and highlight important methodological considerations for those embarking on a programme theory review. METHODS: We compared the performance of an academic database search with a simple Google search and developed an optimised search strategy for the identification primary references (i.e. documents providing the clearest examples of programme theories) associated with the use of Pressure Ulcer Risk Assessment Instruments (PU-RAIs). We identified the number of primary references and the total number of references retrieved per source. We then calculated the number needed to read (NNR) expressed as the total number of titles and abstracts screened to identify one relevant reference from each source. RESULTS: The academic database search (comprising CINAHL, The Cochrane Library, EMBASE, HMIC, Medline) identified 2 /10 primary references with a NNR of 1395.The Google search identified 7/10 primary references with a NNR of 10.1. The combined NNR was 286.3. The optimised search combining Google and CINAHL identified 10/10 primary references with a NNR of 40.2. CONCLUSION: The striking difference between the efficiency of the review's academic database and Google searches in finding relevant references prompted an in-depth comparison of the two types of search. The findings indicate the importance of including grey literature sources such as Google in this particular programme theory search, while acknowledging the need for transparency of methods. Further research is needed to facilitate improved guidance for programme theory searches to enhance practice in the realist field and to save researcher time and therefore resource.

Behavioural activation therapy for depression in adults with non-communicable diseases.

BACKGROUND: Depression is common in people with non-communicable diseases (NCDs) such as cardiovascular disease, diabetes, cancer, and chronic respiratory conditions. The co-existence of depression and NCDs may affect health behaviours, compliance with treatment, physiological factors, and quality of life. This in turn is associated with worse outcomes for both conditions. Behavioural activation is not currently indicated for the treatment of depression in this population in the UK, but is increasingly being used to treat depression in adults. OBJECTIVES: To examine the effects of behavioural activation compared with any control group for the treatment of depression in adults with NCDs. To examine the effects of behavioural activation compared with each control group separately (no treatment, waiting list, other psychological therapy, pharmacological treatment, or any other type of treatment as usual) for the treatment of depression in adults with NCDs. SEARCH METHODS: We searched CCMD-CTR, CENTRAL, Ovid MEDLINE, Embase, four other databases, and two trial registers on 4 October 2019 to identify randomised controlled trials (RCTs) of behavioural activation for depression in participants with NCDs, together with grey literature and reference checking. We applied no restrictions on date, language, or publication status to the searches. SELECTION CRITERIA: We included RCTs of behavioural activation for the treatment of depression in adults with one of four NCDs: cardiovascular disease, diabetes, cancer, and chronic respiratory conditions. Only participants with a formal diagnosis of both depression and an NCD were eligible. Studies were included if behavioural activation was the main component of the intervention. We included studies with any comparator that was not behavioural activation, and regardless of reported outcomes. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane, including independent screening of titles/abstracts and full-text manuscripts, data extraction, and risk of bias assessments in duplicate. Where necessary, we contacted study authors for more information. MAIN RESULTS: We included two studies, contributing data from 181 participants to the analyses. Both studies recruited participants from US hospital clinics; one included people who were recovering from a stroke and the other women with breast cancer. For both studies, the intervention consisted of eight weeks of face-to-face behavioural therapy, with one study comparing to poststroke treatment as usual and the other comparing to problem-solving therapy. Both studies were at risk of performance bias and potential conflict of interest arising from author involvement in the development of the intervention. For one study, risks of selection bias and reporting bias were unclear and the study was judged at high risk of attrition bias. Treatment efficacy (remission) was greater for behavioural activation than for comparators in the short term (risk ratio (RR) 1.53, 95% confidence interval (CI) 0.98 to 2.38; low-certainty evidence) and medium term (RR 1.76, 95% CI 1.01 to 3.08; moderate-certainty evidence), but these estimates lacked precision and effects were reduced in the long term (RR 1.42, 95% CI 0.91 to 2.23; moderate-certainty evidence). We found no evidence of a difference in treatment acceptability in the short term (RR 1.81, 95% CI 0.68 to 4.82) and medium term (RR 0.88, 95% CI 0.25 to 3.10) (low-certainty evidence). There was no evidence of a difference in depression symptoms between behavioural activation and comparators (short term: MD -1.15, 95% CI -2.71 to 0.41; low-certainty evidence). One study found no difference for quality of life (short term: MD 0.40, 95% CI -0.16 to 0.96; low-certainty evidence), functioning (short term: MD 2.70, 95% CI -6.99 to 12.39; low-certainty evidence), and anxiety symptoms (short term: MD -1.70, 95% CI -4.50 to 1.10; low-certainty evidence). Neither study reported data on adverse effects. AUTHORS' CONCLUSIONS: Evidence from this review was not sufficient to draw conclusions on the efficacy and acceptability of behavioural activation for the treatment of depression in adults with NCDs. A future review may wish to include, or focus on, studies of people with subthreshold depression or depression symptoms without a formal diagnosis, as this may inform whether behavioural activation could be used to treat mild or undiagnosed (or both) depressive symptoms in people with NCDs. Evidence from low-resource settings including low- and middle-income countries, for which behavioural activation may offer a feasible alternative to other treatments for depression, would be of interest.

Opioids combined with antidepressants or antiepileptic drugs for cancer pain: Systematic review and meta-analysis.

BACKGROUND: Combining antidepressant or antiepileptic drugs with opioids has resulted in increased pain relief when used for neuropathic pain in non-cancer conditions. However, evidence to support their effectiveness in cancer pain is lacking. AIM: To determine if there is additional benefit when opioids are combined with antidepressant or antiepileptic drugs for cancer pain. DESIGN: Systematic review and meta-analysis. Randomised control trials comparing opioid analgesia in combination with antidepressant or antiepileptic drugs versus opioid monotherapy were sought. Data on pain and adverse events were extracted. Data were pooled using DerSimonian-Laird random-effects meta-analyses, and heterogeneity was assessed. RESULTS: Seven randomised controlled trials that randomised 605 patients were included in the review. Patients' pain was described as neuropathic cancer pain, cancer bone pain and non-specific cancer pain. Four randomised controlled trials were included in the meta-analysis in which opioid in combination with either gabapentin or pregabalin was compared with opioid monotherapy. The pooled standardised mean difference was 0.16 (95% confidence interval, -0.19, 0.51) showing no significant difference in pain relief between the groups. Adverse events were more frequent in the combination arms. Data on amitriptyline, fluvoxamine and phenytoin were inconclusive. CONCLUSION: Combining opioid analgesia with gabapentinoids did not significantly improve pain relief in patients with tumour-related cancer pain compared with opioid monotherapy. Due to the heterogeneity of patient samples, benefit in patients with definite neuropathic cancer pain cannot be excluded. Clinicians should balance the small likelihood of benefit in patients with tumour-related cancer pain against the increased risk of adverse effects of combination therapy.

Measurement of adherence in a randomised controlled trial of a complex intervention: supported self-management for adults with learning disability and type 2 diabetes.

BACKGROUND: Reporting adherence to intervention delivery and uptake is a detailed way of describing what was actually delivered and received, in comparison to what was intended. Measuring and reporting adherence is not routinely done well in complex interventions. The OK Diabetes trial (ISRCTN41897033) aimed to develop and subsequently test the feasibility of implementing a supported self-management intervention in adults with a learning disability and type 2 diabetes. A key study objective was to develop a measure of adherence to the intervention. METHODS: We conducted a systematic review of published literature, extracting data from included papers using a standardised proforma. We undertook a narrative synthesis of papers to determine the form and content of methods for adherence measurement for self-management interventions in this population that had already been developed. We used the framework and data extraction form developed for the review as the basis for an adherence measurement tool that we applied in the OK Diabetes trial. RESULTS: The literature review found variability in the quality and content of adherence measurement and reporting, with no standardised approach. We were able to develop an adherence measure based upon the review, and populate it with data collected during the OK Diabetes trial. The adherence tool proved satisfactory for recording and measuring adherence in the trial. CONCLUSION: There remains a need for a standardised approach to adherence measurement in the field of complex interventions. We have shown that it is possible to produce a simple, feasible measure for assessing adherence in the OK Diabetes trial.

Attaining surgical competency and its implications in surgical clinical trial design: a systematic review of the learning curve in laparoscopic and robot-assisted laparoscopic colorectal cancer surgery.

BACKGROUND: Laparoscopic surgery is increasingly used in the treatment of colorectal cancer and more recently robotic assistance has been advocated. However, the learning curve to achieve surgical proficiency in laparoscopic surgery is ill-defined and subject to many influences. The aim of this review was to comprehensively appraise the literature on the learning curve for laparoscopic and robotic colorectal cancer surgery, and to quantify attainment of surgical proficiency and its implications in surgical clinical trial design. METHODS: A systematic review using a defined search strategy was performed. Included studies had to state an explicit numerical value of the learning curve evaluated by a single parameter or multiple parameters. RESULTS: Thirty-four studies were included, 28 laparoscopic and 6 robot assisted. Of the laparoscopic studies, nine defined the learning curve on the basis of a single parameter. Nine studies used more than one parameter to define learning, and 11 used a cumulative sum (CUSUM) analysis. One study used both a multiparameter and CUSUM analysis. The definition of proficiency was subjective, and the number of operations to achieve it ranged from 5 to 310 cases for laparoscopic and 15-30 cases for robotic surgery. CONCLUSIONS: The learning curve in laparoscopic colorectal surgery is multifaceted and often ill-defined, with poor descriptions of mentorship/supervision. Further, the quantification to attain proficiency is variable. The use of a single parameter to quantify this is simplistic. Multidimensional assessment is recommended; as part of this, the CUSUM model, which assesses trends in multiple surgical outcomes, is useful and appropriate when assessing the learning curve in a clinical setting.

Adoption of technology enabled care to support the management of children and teenagers in rheumatology services: a protocol for a mixed-methods systematic review.

INTRODUCTION: COVID-19 catalysed a rapid move to provide care away from the hospital using online communication platforms. Technology enabled care (TEC) continues to be an important driver in progressing future healthcare services. Due to the complex and chronic nature of conditions seen within paediatric rheumatology, TEC may lead to better outcomes. Despite some growth in published literature into the adoption of TEC in paediatric rheumatology, there is limited synthesis. The aim of this review is to provide a comprehensive understanding and evaluation of the adoption of TEC by patients in paediatric rheumatology services, to establish best practices. METHODS AND ANALYSIS: This proposed mixed-methods systematic review will be conducted by searching a wide variety of healthcare databases, grey literature resources and associated charities and societies, for articles reported in English language. Data extraction will include population demographics, technology intervention, factors affecting adoption of intervention and consequent study outcomes. A parallel-results convergent synthesis design is planned, with independent syntheses of quantitative and qualitative data, followed by comparison of the findings of each synthesis using a narrative approach. Normalisation process theory will be used to identify, characterise and explain implementation factors. The quality of included articles will be assessed using the Mixed Methods Appraisal Tool for research papers and the Authority, Accuracy, Coverage, Objectivity, Date, Significance checklist for grey literature. Overall confidence in quality and strength of evidence will be assessed using the Confidence in the Evidence from Reviews of Qualitative Research tool. ETHICS AND DISSEMINATION: Ethical approval is not required due to the nature of this mixed-methods systematic review. The findings will be disseminated via a peer-reviewed journal, relevant conferences and any other methods (eg, via NHS Trust or NIHR YouTube channels) as advised by paediatric rheumatology patients. PROSPERO REGISTRATION NUMBER: CRD42023443058.

Reducing self-harm in adolescents: the RISA-IPD individual patient data meta-analysis and systematic review.

Background: Self-harm is common in adolescents and a major public health concern. Evidence for effective interventions is lacking. An individual patient data meta-analysis has the potential to provide more reliable estimates of the effects of therapeutic interventions for self-harm than conventional meta-analyses, to explore which treatments are best suited to certain groups. Method: A systematic review and individual patient data meta-analysis of randomised controlled trials of therapeutic interventions to reduce repeat self-harm in adolescents who had a history of self-harm and presented to clinical services. Primary outcome was repetition of self-harm. The methods employed for searches, study screening and selection, and risk of bias assessment are described, with an overview of the outputs of the searching, selection and quality assessment processes. Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidance is followed. Results: We identified a total 39 eligible studies, from 10 countries, where we sought Individual Patient Data (IPD), of which the full sample of participants were eligible in 18 studies and a partial sample of participants were eligible in 21 studies. We obtained IPD from 26 studies of 3448 eligible participants. For our primary outcome, repetition of self-harm, only 6 studies were rated as low risk of bias with 10 rated as high risk (although 2 of these were for secondary outcomes only). Conclusions: Obtaining individual patient data for meta-analyses is possible but very time-consuming, despite clear guidance from funding bodies that researchers should share their data appropriately. More attention needs to be paid to seeking appropriate consent from study participants for (pseudo) anonymised data-sharing and institutions need to collaborate on agreeing template data-sharing agreements. Researchers and funders need to consider issues of research design more carefully. Our next step is to analyse all the data we have collected to see if it will tell us more about how we might prevent repetition of self-harm in young people. Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 17/117/11. A plain language summary of this research article is available on the NIHR Journals Library Website https://doi.org/10.3310/GTNT6331.

Self-harm is very common in young people and leads to an increased risk of death by suicide. Research so far has not provided clear evidence about which interventions can help to prevent self-harm repetition when young people present to services having harmed themselves. One way to understand what might help is to pool the results from lots of different clinical trials ­ this is known as a meta-analysis. This has already been done using the data published in research articles but has not led to clearer conclusions. In part this is because the information available in published articles is patchy and inconsistent which makes pooling the information and analysing it, difficult. A more useful approach is to ask researchers who led the clinical trials for their original 'raw' data and then pool and analyse all that data ­ this is known as an individual patient data meta-analysis. This has the added benefit that it is possible to include studies where only some of the participants are young people. We did this, and were able to identify many more study participants along with their data, compared to earlier meta-analyses. In this article, we describe how we searched for relevant research studies and the methods we used to obtain individual patient data from other researchers. We also describe our rating of the research quality of the studies we identified. We identified more studies, with many more participants in total, than in previous pooled study research. Gathering the data from other researchers was very time-consuming and not everyone was willing or able to share their data. When we rated the quality of the studies that we found, many were not of high quality. Our next step is to analyse all the data we have collected to see if it will tell us more about how we might prevent repetition of self-harm in young people.

How can interventions more directly address drivers of unprofessional behaviour between healthcare staff?

Unprofessional behaviours (UBs) between healthcare staff are widespread and have negative impacts on patient safety, staff well-being and organisational efficiency. However, knowledge of how to address UBs is lacking. Our recent realist review analysed 148 sources including 42 reports of interventions drawing on different behaviour change strategies and found that interventions insufficiently explain their rationale for using particular strategies. We also explored the drivers of UBs and how these may interact. In our analysis, we elucidated both common mechanisms underlying both how drivers increase UB and how strategies address UB, enabling the mapping of strategies against drivers they address. For example, social norm-setting strategies work by fostering a more professional social norm, which can help tackle the driver 'reduced social cohesion'. Our novel programme theory, presented here, provides an increased understanding of what strategies might be effective to adddress specific drivers of UB. This can inform logic model design for those seeking to develop interventions addressing UB in healthcare settings.

Practices of falls risk assessment and prevention in acute hospital settings: a realist investigation.

Background: Falls are the most common safety incident reported by acute hospitals. The National Institute of Health and Care Excellence recommends multifactorial falls risk assessment and tailored interventions, but implementation is variable. Aim: To determine how and in what contexts multifactorial falls risk assessment and tailored interventions are used in acute National Health Service hospitals in England. Design: Realist review and multisite case study. (1) Systematic searches to identify stakeholders' theories, tested using empirical data from primary studies. Review of falls prevention policies of acute Trusts. (2) Theory testing and refinement through observation, staff interviews (n = 50), patient and carer interviews (n = 31) and record review (n = 60). Setting: Three Trusts, one orthopaedic and one older person ward in each. Results: Seventy-eight studies were used for theory construction and 50 for theory testing. Four theories were explored. (1) Leadership: wards had falls link practitioners but authority to allocate resources for falls prevention resided with senior nurses. (2) Shared responsibility: a key falls prevention strategy was patient supervision. This fell to nursing staff, constraining the extent to which responsibility for falls prevention could be shared. (3) Facilitation: assessments were consistently documented but workload pressures could reduce this to a tick-box exercise. Assessment items varied. While individual patient risk factors were identified, patients were categorised as high or low risk to determine who should receive supervision. (4) Patient participation: nursing staff lacked time to explain to patients their falls risks or how to prevent themselves from falling, although other staff could do so. Sensitive communication could prevent patients taking actions that increase their risk of falling. Limitations: Within the realist review, we completed synthesis for only two theories. We could not access patient records before observations, preventing assessment of whether care plans were enacted. Conclusions: (1) Leadership: There should be a clear distinction between senior nurses' roles and falls link practitioners in relation to falls prevention; (2) shared responsibility: Trusts should consider how processes and systems, including the electronic health record, can be revised to better support a multidisciplinary approach, and alternatives to patient supervision should be considered; (3) facilitation: Trusts should consider how to reduce documentation burden and avoid tick-box responses, and ensure items included in the falls risk assessment tools align with guidance. Falls risk assessment tools and falls care plans should be presented as tools to support practice, rather than something to be audited; (4) patient participation: Trusts should consider how they can ensure patients receive individualised information about risks and preventing falls and provide staff with guidance on brief but sensitive ways to talk with patients to reduce the likelihood of actions that increase their risk of falling. Future work: (1) Development and evaluation of interventions to support multidisciplinary teams to undertake, and involve patients in, multifactorial falls risk assessment and selection and delivery of tailored interventions; (2) mixed method and economic evaluations of patient supervision; (3) evaluation of engagement support workers, volunteers and/or carers to support falls prevention. Research should include those with cognitive impairment and patients who do not speak English. Study registration: This study is registered as PROSPERO CRD42020184458. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: NIHR129488) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 5. See the NIHR Funding and Awards website for further award information.

Many accidental falls by older people in hospitals could be avoided. There are guidelines to prevent falls, but some hospitals are better at following them than others. This study aimed to find out why. First, we looked at research and hospitals' falls policies for ideas about what stops falls. With advice from service users, we tested these ideas in four hospitals in England, watching how falls were prevented on wards for older people and people who need bone care, and talking to 50 staff, 28 patients and 3 carers. We found the following: Falls leadership: wards had staff called falls link practitioners who supported falls prevention, but senior nurses, not link practitioners, made the most important decisions. Sharing responsibility: patients with falls risks were monitored to try to stop falls. Because only nursing teams were always present to monitor patients, they had most responsibility for preventing falls. This limited sharing responsibility with other staff. Computer tools: nurses used computers to record prevention work, but high workloads could make this a 'tick-box' exercise. Computer tools reminded them to do this, although tools varied. Patients had individual falls plans, but they were also ranked more generally as high or low risk of falling, with 'high-risk' patients being monitored. Patient involvement: nursing staff did not have time to explain to patients how to prevent falls, but other staff could have such conversations. Many patients had problems like dementia and found it difficult to follow safety advice, although some could take steps to keep safe, with sensitive staff support. We need to involve patients, carers and different staff in falls prevention. Hospitals could develop computer systems to support this, think how to involve more ward staff, and provide guidance on helpful ways to talk with patients about falls.

School lives of adolescent school students living with chronic physical health conditions: a qualitative evidence synthesis.

OBJECTIVE: Assess the existing evidence base in order to synthesise the current qualitative findings for the impact of chronic health conditions on the school lives of young people. DESIGN: Qualitative evidence synthesis using thematic synthesis. PATIENTS: Young people aged 11-18 years with a chronic health condition from one of the following groups: oncology, cystic fibrosis, diabetes, asthma, rheumatology, neuromuscular, colorectal, chronic pain, allergies and dermatology. OUTCOME MEASURE: Qualitative findings and discussions present in included studies formed the data for the thematic synthesis. RESULTS: From a search identifying 19 311 records, a sample of 35 papers were included. The included papers represented 15 countries and primarily employed interviews as part of data collection. Thematic synthesis resulted in six themes: 'keeping up/catching up/missing out/looking forward'; 'identity'; 'relationship with peers'; 'normality and difference'; 'autonomy'; 'relationships with staff'. CONCLUSIONS: Thematic synthesis highlighted the commonalities, rather than divergence, of issues for young people across different chronic conditions. Policies need to be based on the experiences of the people they aim to provide for, and while attendance and attainment remain important, there is clearly more that needs to be considered when gathering data, designing interventions and developing policies to support this population. It may also be advisable for clinical professionals to include the broader psychosocial aspects of school life in discussions and plans to support young people with long-term conditions. PROSPERO REGISTRATION NUMBER: CRD42021278153.

Mid- to late-term follow-up of primary hip and knee arthroplasty: the UK SAFE evidence-based recommendations.

To review the evidence and reach consensus on recommendations for follow-up after total hip and knee arthroplasty. A programme of work was conducted, including: a systematic review of the clinical and cost-effectiveness literature; analysis of routine national datasets to identify pre-, peri-, and postoperative predictors of mid-to-late term revision; prospective data analyses from 560 patients to understand how patients present for revision surgery; qualitative interviews with NHS managers and orthopaedic surgeons; and health economic modelling. Finally, a consensus meeting considered all the work and agreed the final recommendations and research areas. The UK poSt Arthroplasty Follow-up rEcommendations (UK SAFE) recommendations apply to post-primary hip and knee arthroplasty follow-up. The ten-year time point is based on a lack of robust evidence beyond ten years. The term 'complex cases' refers to individual patient and surgical factors that may increase the risk for arthroplasty failure. For Orthopaedic Data Evaluation Panel (ODEP) 10A* minimum implants, it is safe to disinvest in routine follow-up from one to years post-non-complex hip and knee arthroplasty provided there is rapid access to orthopaedic review. For ODEP 10A* minimum implants in complex cases, or non-ODEP 10A* minimum implants, periodic follow-up post-hip and knee arthroplasty may be required from one to ten years. At ten years post-hip and knee arthroplasty, clinical and radiological evaluation is recommended. After ten years post-hip and knee arthroplasty, frequency of further follow-up should be based on the ten-year assessment; ongoing rapid access to orthopaedic review is still required. Complex cases, implants not meeting the ODEP 10A* criteria, and follow-up after revision surgery are not covered by this recommendation.