ABSTRACT
Background: There are increasing demands on Emergency Medical Services. More efficient treatment pathways are required to support conveyance decision making and patient referral in prehospital care. Point of Care testing is increasingly available and utilised across the NHS to support optimal ways of working. We aimed to design and conduct a Multiple Criteria Decision Analysis to prioritise in vitro point of care tests and use cases for inclusion in a platform trial of in vitro point of care testing in UK Emergency Medical Services. Methods: We designed a Multiple Criteria Decision Analysis that included systematic scoping reviews stakeholder recruitment, two stakeholder surveys and two stakeholder workshops to scope the use cases, explore criteria and map use cases, evaluate the criteria and measure the use cases against the criteria. Results: We recruited 32 stakeholders. We developed a scoring matrix with 4 criteria for scoring the use cases and 8 criteria for scoring the point of care tests and applied weighting determined from survey results. Use cases were scored by the stakeholders against 4 criteria. The 3 highest scoring use cases were point of care troponin testing in: possible Acute Myocardial Infarction, lactate testing in suspected sepsis and in trauma. We developed the process for scoring the point of care tests to be completed close to a proposed trial to allow for a changes in technology. Conclusions: We successfully designed a Multiple Criteria Decision Analysis to identify use cases and candidate tests for inclusion in a future platform trial of in vitro point of care testing in UK Emergency Medical Services. We identified 3 use cases for evaluation in a platform trial of in vitro point of care testing: troponin testing in possible acute myocardial infarction, lactate testing in suspected sepsis and lactate testing to identify occult haemorrhage in trauma.
ABSTRACT
Background: Disciplinary behaviour management strategies are implemented in schools to manage pupil behaviour. There is limited evidence of their intended impact on behaviour but there is growing concern around the potential negative impacts on pupil wellbeing. Methods: We carried out a systematic review to examine the impact of these strategies on psychosocial outcomes in pupils (PROSPERO Registration: CRD42021285427). We searched multiple sources and double-screened titles, abstracts, and full texts. Data extraction and risk of bias assessment were done by one reviewer and checked by another. Results were narratively synthesised. Results: We included 14 studies, from 5375 citations, assessing temporary suspension (n=10), verbal reprimand (n=2), and mixed strategies (n=2). Depression was the most common outcome (n=7), followed by academic grades (n=4) and behaviour in class (n=4). All except one study were at high risk of bias. We found a recurring pattern in the evidence of disciplinary strategies associated with poor mental wellbeing and behaviour in pupils. The effect on academic attainment was unclear. Conclusions: Disciplinary behaviour management strategies may have negative impact on pupil mental wellbeing and class behaviour. These important consequences should be assessed in better designed studies before these strategies are implemented.
How does school discipline affect pupil mental health and wellbeing? A systematic review In England, a variety of approaches are used in schools to manage pupils' behaviour. There isn't much evidence about their impact on behaviour, but there's growing concern they might negatively affect pupils' wellbeing. We systematically reviewed the published research to understand the impact of these behaviour management strategies on pupils' wellbeing. We searched multiple sources and two people looked at titles, abstracts and full papers. One reviewer extracted the data and assessed the studies for risk of bias, while another checked this work. Results from all studies were combined together in text and tables. We included 14 studies from the 5,375 papers that we looked at. Included studies explored at a range of strategies, including temporary suspension (10 studies), verbal reprimand or being told off (2 studies), and a combination of strategies (2 studies). Seven studies looked at whether these strategies led to depression, four looked at the impact on exam grades and four on behaviour in class. All except one study were at high risk of bias, meaning we can't fully trust their findings. Many of the studies showed these disciplinary strategies were linked to poor mental wellbeing and behaviour in pupils. The effect on exam results wasn't clear. It appears pupil mental wellbeing and class behaviour was made worse by these strategies. These are important impacts and should be researched in high quality studies before these strategies are used further.
ABSTRACT
An assessment of the validity of studies is an essential component of most evidence syntheses (systematic reviews) to understand the risk of bias (ROB) and applicability of the evidence. A formal validity assessment requires a structured and comprehensive approach, which can be implemented using an assessment tool, specifically developed for this purpose. Many different tools are available, marking it difficult for researchers to choose the best tool for their evidence synthesis. We have established the LATITUDES Network to assist researchers in identifying the most appropriate tool to use in their evidence synthesis and to support researchers using these tools. The LATITUDES website (www.latitudes-network.org) includes a searchable library of validity assessment tools designed for use in evidence syntheses, bringing tools together in one place and providing researchers with clear information on suitable tools, categorized by study design. The website also provides links to training on the process of validity assessment and a list of tools currently under development. To be included in the LATITUDES library, tools must meet the following criteria: be designed for use in evidence syntheses; assess multidimensional aspects of validity of individual studies or reviews; and be developed for use by the wider research community rather than for a single research group. We highlight 'key' tools, those that are considered to be the most robust and reliable tools based on prespecified criteria agreed in conjunction with our advisory board, an international group of experts in the area of evidence synthesis and ROB tools.
ABSTRACT
BACKGROUND: Prevention of obesity in adolescents is an international public health priority. The prevalence of overweight and obesity is over 25% in North and South America, Australia, most of Europe, and the Gulf region. Interventions that aim to prevent obesity involve strategies that promote healthy diets or 'activity' levels (physical activity, sedentary behaviour and/or sleep) or both, and work by reducing energy intake and/or increasing energy expenditure, respectively. There is uncertainty over which approaches are more effective, and numerous new studies have been published over the last five years since the previous version of this Cochrane Review. OBJECTIVES: To assess the effects of interventions that aim to prevent obesity in adolescents by modifying dietary intake or 'activity' levels, or a combination of both, on changes in BMI, zBMI score and serious adverse events. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was February 2023. SELECTION CRITERIA: Randomised controlled trials in adolescents (mean age 12 years and above but less than 19 years), comparing diet or 'activity' interventions (or both) to prevent obesity with no intervention, usual care, or with another eligible intervention, in any setting. Studies had to measure outcomes at a minimum of 12 weeks post baseline. We excluded interventions designed primarily to improve sporting performance. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our outcomes were BMI, zBMI score and serious adverse events, assessed at short- (12 weeks to < 9 months from baseline), medium- (9 months to < 15 months) and long-term (≥ 15 months) follow-up. We used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: This review includes 74 studies (83,407 participants); 54 studies (46,358 participants) were included in meta-analyses. Sixty studies were based in high-income countries. The main setting for intervention delivery was schools (57 studies), followed by home (nine studies), the community (five studies) and a primary care setting (three studies). Fifty-one interventions were implemented for less than nine months; the shortest was conducted over one visit and the longest over 28 months. Sixty-two studies declared non-industry funding; five were funded in part by industry. Dietary interventions versus control The evidence is very uncertain about the effects of dietary interventions on body mass index (BMI) at short-term follow-up (mean difference (MD) -0.18, 95% confidence interval (CI) -0.41 to 0.06; 3 studies, 605 participants), medium-term follow-up (MD -0.65, 95% CI -1.18 to -0.11; 3 studies, 900 participants), and standardised BMI (zBMI) at long-term follow-up (MD -0.14, 95% CI -0.38 to 0.10; 2 studies, 1089 participants); all very low-certainty evidence. Compared with control, dietary interventions may have little to no effect on BMI at long-term follow-up (MD -0.30, 95% CI -1.67 to 1.07; 1 study, 44 participants); zBMI at short-term (MD -0.06, 95% CI -0.12 to 0.01; 5 studies, 3154 participants); and zBMI at medium-term (MD 0.02, 95% CI -0.17 to 0.21; 1 study, 112 participants) follow-up; all low-certainty evidence. Dietary interventions may have little to no effect on serious adverse events (two studies, 377 participants; low-certainty evidence). Activity interventions versus control Compared with control, activity interventions do not reduce BMI at short-term follow-up (MD -0.64, 95% CI -1.86 to 0.58; 6 studies, 1780 participants; low-certainty evidence) and probably do not reduce zBMI at medium- (MD 0, 95% CI -0.04 to 0.05; 6 studies, 5335 participants) or long-term (MD -0.05, 95% CI -0.12 to 0.02; 1 study, 985 participants) follow-up; both moderate-certainty evidence. Activity interventions do not reduce zBMI at short-term follow-up (MD 0.02, 95% CI -0.01 to 0.05; 7 studies, 4718 participants; high-certainty evidence), but may reduce BMI slightly at medium-term (MD -0.32, 95% CI -0.53 to -0.11; 3 studies, 2143 participants) and long-term (MD -0.28, 95% CI -0.51 to -0.05; 1 study, 985 participants) follow-up; both low-certainty evidence. Seven studies (5428 participants; low-certainty evidence) reported data on serious adverse events: two reported injuries relating to the exercise component of the intervention and five reported no effect of intervention on reported serious adverse events. Dietary and activity interventions versus control Dietary and activity interventions, compared with control, do not reduce BMI at short-term follow-up (MD 0.03, 95% CI -0.07 to 0.13; 11 studies, 3429 participants; high-certainty evidence), and probably do not reduce BMI at medium-term (MD 0.01, 95% CI -0.09 to 0.11; 8 studies, 5612 participants; moderate-certainty evidence) or long-term (MD 0.06, 95% CI -0.04 to 0.16; 6 studies, 8736 participants; moderate-certainty evidence) follow-up. They may have little to no effect on zBMI in the short term, but the evidence is very uncertain (MD -0.09, 95% CI -0.2 to 0.02; 3 studies, 515 participants; very low-certainty evidence), and they may not reduce zBMI at medium-term (MD -0.05, 95% CI -0.1 to 0.01; 6 studies, 3511 participants; low-certainty evidence) or long-term (MD -0.02, 95% CI -0.05 to 0.01; 7 studies, 8430 participants; low-certainty evidence) follow-up. Four studies (2394 participants) reported data on serious adverse events (very low-certainty evidence): one reported an increase in weight concern in a few adolescents and three reported no effect. AUTHORS' CONCLUSIONS: The evidence demonstrates that dietary interventions may have little to no effect on obesity in adolescents. There is low-certainty evidence that activity interventions may have a small beneficial effect on BMI at medium- and long-term follow-up. Diet plus activity interventions may result in little to no difference. Importantly, this updated review also suggests that interventions to prevent obesity in this age group may result in little to no difference in serious adverse effects. Limitations of the evidence include inconsistent results across studies, lack of methodological rigour in some studies and small sample sizes. Further research is justified to investigate the effects of diet and activity interventions to prevent childhood obesity in community settings, and in young people with disabilities, since very few ongoing studies are likely to address these. Further randomised trials to address the remaining uncertainty about the effects of diet, activity interventions, or both, to prevent childhood obesity in schools (ideally with zBMI as the measured outcome) would need to have larger samples.
Subject(s)
Body Mass Index , Exercise , Pediatric Obesity , Randomized Controlled Trials as Topic , Humans , Adolescent , Child , Pediatric Obesity/prevention & control , Female , Energy Intake , Male , Sedentary Behavior , Bias , Diet, Healthy , Research Support as Topic , SleepABSTRACT
BACKGROUND: Breast-conserving surgery with adjuvant radiotherapy and mastectomy are currently offered as equivalent surgical options for early-stage breast cancer based on RCTs from the 1970s and 1980s. However, the treatment of breast cancer has evolved and recent observational studies suggest a survival advantage for breast-conserving surgery with adjuvant radiotherapy. A systematic review and meta-analysis was undertaken to summarize the contemporary evidence regarding survival after breast-conserving surgery with adjuvant radiotherapy versus mastectomy for women with early-stage breast cancer. METHODS: A systematic search of MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL), and Embase that identified studies published between 1 January 2000 and 18 December 2023 comparing overall survival after breast-conserving surgery with adjuvant radiotherapy versus mastectomy for patients with unilateral stage 1-3 breast cancer was undertaken. The main exclusion criteria were studies evaluating neoadjuvant chemotherapy, rare breast cancer subtypes, and specific breast cancer populations. The ROBINS-I tool was used to assess risk of bias, with the overall certainty of evidence assessed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) tool. Studies without critical risk of bias were included in a quantitative meta-analysis. RESULTS: From 11 750 abstracts, 108 eligible articles were identified, with one article including two studies; 29 studies were excluded from the meta-analysis due to an overall critical risk of bias, 42 studies were excluded due to overlapping study populations, and three studies were excluded due to reporting incompatible results. A total of 35 observational studies reported survival outcomes for 909 077 patients (362 390 patients undergoing mastectomy and 546 687 patients undergoing breast-conserving surgery with adjuvant radiotherapy). The pooled HR was 0.72 (95% c.i. 0.68 to 0.75, P < 0.001), demonstrating improved overall survival for patients undergoing breast-conserving surgery with adjuvant radiotherapy. The overall certainty of the evidence was very low. CONCLUSION: This meta-analysis provides evidence suggesting a survival advantage for women undergoing breast-conserving surgery with adjuvant radiotherapy for early-stage breast cancer compared with mastectomy. Although these results should be interpreted with caution, they should be shared with patients to support informed surgical decision-making.
Subject(s)
Breast Neoplasms , Mastectomy, Segmental , Humans , Radiotherapy, Adjuvant , Female , Breast Neoplasms/radiotherapy , Breast Neoplasms/mortality , Breast Neoplasms/surgery , Breast Neoplasms/pathology , Neoplasm Staging , MastectomyABSTRACT
BACKGROUND: Prevention of obesity in children is an international public health priority given the prevalence of the condition (and its significant impact on health, development and well-being). Interventions that aim to prevent obesity involve behavioural change strategies that promote healthy eating or 'activity' levels (physical activity, sedentary behaviour and/or sleep) or both, and work by reducing energy intake and/or increasing energy expenditure, respectively. There is uncertainty over which approaches are more effective and numerous new studies have been published over the last five years, since the previous version of this Cochrane review. OBJECTIVES: To assess the effects of interventions that aim to prevent obesity in children by modifying dietary intake or 'activity' levels, or a combination of both, on changes in BMI, zBMI score and serious adverse events. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was February 2023. SELECTION CRITERIA: Randomised controlled trials in children (mean age 5 years and above but less than 12 years), comparing diet or 'activity' interventions (or both) to prevent obesity with no intervention, usual care, or with another eligible intervention, in any setting. Studies had to measure outcomes at a minimum of 12 weeks post baseline. We excluded interventions designed primarily to improve sporting performance. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our outcomes were body mass index (BMI), zBMI score and serious adverse events, assessed at short- (12 weeks to < 9 months from baseline), medium- (9 months to < 15 months) and long-term (≥ 15 months) follow-up. We used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: This review includes 172 studies (189,707 participants); 149 studies (160,267 participants) were included in meta-analyses. One hundred forty-six studies were based in high-income countries. The main setting for intervention delivery was schools (111 studies), followed by the community (15 studies), the home (eight studies) and a clinical setting (seven studies); one intervention was conducted by telehealth and 31 studies were conducted in more than one setting. Eighty-six interventions were implemented for less than nine months; the shortest was conducted over one visit and the longest over four years. Non-industry funding was declared by 132 studies; 24 studies were funded in part or wholly by industry. Dietary interventions versus control Dietary interventions, compared with control, may have little to no effect on BMI at short-term follow-up (mean difference (MD) 0, 95% confidence interval (CI) -0.10 to 0.10; 5 studies, 2107 participants; low-certainty evidence) and at medium-term follow-up (MD -0.01, 95% CI -0.15 to 0.12; 9 studies, 6815 participants; low-certainty evidence) or zBMI at long-term follow-up (MD -0.05, 95% CI -0.10 to 0.01; 7 studies, 5285 participants; low-certainty evidence). Dietary interventions, compared with control, probably have little to no effect on BMI at long-term follow-up (MD -0.17, 95% CI -0.48 to 0.13; 2 studies, 945 participants; moderate-certainty evidence) and zBMI at short- or medium-term follow-up (MD -0.06, 95% CI -0.13 to 0.01; 8 studies, 3695 participants; MD -0.04, 95% CI -0.10 to 0.02; 9 studies, 7048 participants; moderate-certainty evidence). Five studies (1913 participants; very low-certainty evidence) reported data on serious adverse events: one reported serious adverse events (e.g. allergy, behavioural problems and abdominal discomfort) that may have occurred as a result of the intervention; four reported no effect. Activity interventions versus control Activity interventions, compared with control, may have little to no effect on BMI and zBMI at short-term or long-term follow-up (BMI short-term: MD -0.02, 95% CI -0.17 to 0.13; 14 studies, 4069 participants; zBMI short-term: MD -0.02, 95% CI -0.07 to 0.02; 6 studies, 3580 participants; low-certainty evidence; BMI long-term: MD -0.07, 95% CI -0.24 to 0.10; 8 studies, 8302 participants; zBMI long-term: MD -0.02, 95% CI -0.09 to 0.04; 6 studies, 6940 participants; low-certainty evidence). Activity interventions likely result in a slight reduction of BMI and zBMI at medium-term follow-up (BMI: MD -0.11, 95% CI -0.18 to -0.05; 16 studies, 21,286 participants; zBMI: MD -0.05, 95% CI -0.09 to -0.02; 13 studies, 20,600 participants; moderate-certainty evidence). Eleven studies (21,278 participants; low-certainty evidence) reported data on serious adverse events; one study reported two minor ankle sprains and one study reported the incident rate of adverse events (e.g. musculoskeletal injuries) that may have occurred as a result of the intervention; nine studies reported no effect. Dietary and activity interventions versus control Dietary and activity interventions, compared with control, may result in a slight reduction in BMI and zBMI at short-term follow-up (BMI: MD -0.11, 95% CI -0.21 to -0.01; 27 studies, 16,066 participants; zBMI: MD -0.03, 95% CI -0.06 to 0.00; 26 studies, 12,784 participants; low-certainty evidence) and likely result in a reduction of BMI and zBMI at medium-term follow-up (BMI: MD -0.11, 95% CI -0.21 to 0.00; 21 studies, 17,547 participants; zBMI: MD -0.05, 95% CI -0.07 to -0.02; 24 studies, 20,998 participants; moderate-certainty evidence). Dietary and activity interventions compared with control may result in little to no difference in BMI and zBMI at long-term follow-up (BMI: MD 0.03, 95% CI -0.11 to 0.16; 16 studies, 22,098 participants; zBMI: MD -0.02, 95% CI -0.06 to 0.01; 22 studies, 23,594 participants; low-certainty evidence). Nineteen studies (27,882 participants; low-certainty evidence) reported data on serious adverse events: four studies reported occurrence of serious adverse events (e.g. injuries, low levels of extreme dieting behaviour); 15 studies reported no effect. Heterogeneity was apparent in the results for all outcomes at the three follow-up times, which could not be explained by the main setting of the interventions (school, home, school and home, other), country income status (high-income versus non-high-income), participants' socioeconomic status (low versus mixed) and duration of the intervention. Most studies excluded children with a mental or physical disability. AUTHORS' CONCLUSIONS: The body of evidence in this review demonstrates that a range of school-based 'activity' interventions, alone or in combination with dietary interventions, may have a modest beneficial effect on obesity in childhood at short- and medium-term, but not at long-term follow-up. Dietary interventions alone may result in little to no difference. Limited evidence of low quality was identified on the effect of dietary and/or activity interventions on severe adverse events and health inequalities; exploratory analyses of these data suggest no meaningful impact. We identified a dearth of evidence for home and community-based settings (e.g. delivered through local youth groups), for children living with disabilities and indicators of health inequities.
Subject(s)
Body Mass Index , Exercise , Pediatric Obesity , Child , Child, Preschool , Female , Humans , Male , Bias , Diet, Healthy , Energy Intake , Pediatric Obesity/prevention & control , Randomized Controlled Trials as Topic , Sedentary Behavior , SleepABSTRACT
Rates of mental health problems among medical students have prompted efforts to reduce stress during medical training. However, stress can be motivating and is a feature of clinical work. This qualitative study explores what makes an experience stressful, and how medical students respond to such experiences. In-depth interviews were conducted with a purposive sample of 15 medical students. Experiences were distressing when they threatened students' self-perception, goals or coping mechanisms, or when they reminded the student of distressing past events. Moderate stress was motivating and could build resilience. Students selected coping mechanisms based on their availability, acceptability, likely outcome and their previous experience of using these mechanisms. Social support, extra-curricular activities and exercise were helpful. High levels of distress, poor self-esteem and course factors, including remote placements, impaired engagement with coping strategies. Perception of stressors as being insurmountable or beyond one's control, led to increasing distress and the adoption of avoidant coping strategies. University strategies need to consider the beneficial effects of stress and seek to bolster coping resources as well as minimising unnecessary sources of stress.
ABSTRACT
OBJECTIVES: The aim of this review was to identify factors associated with multiple visits to emergency department (ED) services for mental health care in adolescents. METHODS: Electronic databases (MEDLINE, PsycINFO, Embase, CINAHL, Web of Science and ProQuest Dissertations & Thesis Global) were searched for evidence that presented an association between risk factors or correlates of multiple visits to the emergency departmental for mental health care by 10-24 year olds. High impact use was defined as at least one return ED visit for mental health care. Primary studies of any quantitative design were included, with no exclusions based on language or country and all possible risk factors were considered. Data were extracted and synthesised using quantitative methods; frequencies of positive, negative and null associations were summarised for categories of potential risk factors. RESULTS: Sixty-five studies were included in the review. Most studies were from North America and reported a wide range of measures of high impact ED use, the most common being a binary indicator of multiple ED visits. Sex/gender and age were the most frequently reported risk factors. Measure of previous or concurrent access to mental health care was consistently positively associated with high impact use. Having private health insurance, compared with public or no insurance, was generally negatively associated with high impact use. Proxy measures of socioeconomic position (SEP) showed associations between lower SEP and more high impact use in a small number of studies. No other factors were consistently or uniformly associated with high impact use. CONCLUSIONS: The review identified a substantial evidence base but due to the variability in study design and measurement of both risk factors and outcomes, no consistent risk factors emerged. More research is needed, particularly outside North America, using robust methods and high quality routinely collected data.
Subject(s)
Emergency Service, Hospital , Humans , Adolescent , Emergency Service, Hospital/statistics & numerical data , Risk Factors , Mental Health Services/statistics & numerical data , Mental Disorders/therapy , Mental Disorders/epidemiology , Male , Child , Female , Young Adult , Health Services Accessibility/statistics & numerical data , Emergency Room VisitsABSTRACT
BACKGROUND: Virtual wards (VWs) deliver multidisciplinary care at home to people with frailty who are at high risk of a crisis or in crisis, aiming to mitigate the risk of acute hospital admission. Different VW models exist, and evidence of effectiveness is inconsistent. AIM: We conducted a rapid realist review to identify different VW models and to develop explanations for how and why VWs could deliver effective frailty management. METHODS: We searched published and grey literature to identify evidence on multidisciplinary VWs. Information on how and why VWs might 'work' was extracted and synthesised into context-mechanism-outcome configurations with input from clinicians and patient/public contributors. RESULTS: We included 17 peer-reviewed and 11 grey literature documents. VWs could be short-term and acute (1-21 days), or longer-term and preventative (typically 3-7 months). Effective VW operation requires common standards agreements, information sharing processes, an appropriate multidisciplinary team that plans patient care remotely, and good co-ordination. VWs may enable delivery of frailty interventions through appropriate selection of patients, comprehensive assessment including medication review, integrated case management and proactive care. Important components for patients and caregivers are good communication with the VW, their experience of care at home, and feeling involved, safe and empowered to manage their condition. CONCLUSIONS: Insights gained from this review could inform implementation or evaluation of VWs for frailty. A combination of acute and longer-term VWs may be needed within a whole system approach. Proactive care is recommended to avoid frailty-related crises.
Subject(s)
Frailty , Humans , Frailty/diagnosis , Frailty/therapy , Hospitalization , HospitalsABSTRACT
BACKGROUND: Observational epidemiologic studies provide critical data for the evaluation of the potential effects of environmental, occupational and behavioural exposures on human health. Systematic reviews of these studies play a key role in informing policy and practice. Systematic reviews should incorporate assessments of the risk of bias in results of the included studies. OBJECTIVE: To develop a new tool, Risk Of Bias In Non-randomized Studies - of Exposures (ROBINS-E) to assess risk of bias in estimates from cohort studies of the causal effect of an exposure on an outcome. METHODS AND RESULTS: ROBINS-E was developed by a large group of researchers from diverse research and public health disciplines through a series of working groups, in-person meetings and pilot testing phases. The tool aims to assess the risk of bias in a specific result (exposure effect estimate) from an individual observational study that examines the effect of an exposure on an outcome. A series of preliminary considerations informs the core ROBINS-E assessment, including details of the result being assessed and the causal effect being estimated. The assessment addresses bias within seven domains, through a series of 'signalling questions'. Domain-level judgements about risk of bias are derived from the answers to these questions, then combined to produce an overall risk of bias judgement for the result, together with judgements about the direction of bias. CONCLUSION: ROBINS-E provides a standardized framework for examining potential biases in results from cohort studies. Future work will produce variants of the tool for other epidemiologic study designs (e.g. case-control studies). We believe that ROBINS-E represents an important development in the integration of exposure assessment, evidence synthesis and causal inference.
Subject(s)
Bias , Environmental Exposure , Humans , Environmental Exposure/statistics & numerical data , Follow-Up Studies , Observational Studies as Topic , Cohort Studies , Epidemiologic Studies , Risk Assessment/methodsABSTRACT
BACKGROUND: Centor and McIsaac scores are clinical prediction rules for diagnosing group A streptococcus (GAS) infection in patients with pharyngitis. Their recommended thresholds vary between guidelines. OBJECTIVES: To estimate the sensitivity and specificity of the McIsaac and Centor scores to diagnose GAS pharyngitis and evaluate their impact on antibiotic prescribing at each threshold in patients presenting to secondary care. DATA SOURCES: MEDLINE, Embase, and Web of Science were searched from inception to September 2022. STUDY ELIGIBILITY CRITERIA: Studies of patients presenting with acute pharyngitis to emergency or outpatient clinics that estimated the accuracy of McIsaac or Centor scores against throat cultures and/or rapid antigen detection tests (RADT) as reference standards. TESTS: Centor or McIsaac score. REFERENCE STANDARD: Throat cultures and/or RADT. ASSESSMENT OF RISK OF BIAS: Quality Assessment of Diagnostic Accuracy Studies. METHODS OF DATA SYNTHESIS: The sensitivities and specificities of the McIsaac and Centor scores were pooled at each threshold using bivariate random effects meta-analysis. RESULTS: Fourteen studies were included (eight McIsaac and six Centor scores). Eight studies had unclear and six had a high risk of bias. The McIsaac score had higher estimated sensitivity and lower specificity relative to Centor scores at equivalent thresholds but with wide and overlapping confidence regions. Using either score as a triage to RADT to decide antibiotic treatment would reduce antibiotic prescription to patients with non-GAS pharyngitis relative to RADT test for everyone, but also reduce antibiotic prescription to patients with GAS. DISCUSSION: Centor and McIsaac scores are equally ineffective at triaging patients who need antibiotics presenting with pharyngitis at hospitals. At high thresholds, too many true positive cases are missed, whereas at low thresholds, too many false positives are treated, leading to the over prescription of antibiotics. The former may be compensated by adequate safety netting by clinicians, ensuring that patients can seek help if symptoms worsen.
Subject(s)
Anti-Bacterial Agents , Pharyngitis , Sensitivity and Specificity , Streptococcal Infections , Streptococcus pyogenes , Pharyngitis/microbiology , Pharyngitis/diagnosis , Pharyngitis/drug therapy , Humans , Streptococcal Infections/diagnosis , Streptococcal Infections/drug therapy , Streptococcal Infections/microbiology , Anti-Bacterial Agents/therapeutic use , Secondary Care , Clinical Decision RulesABSTRACT
OBJECTIVES: Evidence-based research (EBR) is the systematic and transparent use of prior research to inform a new study so that it answers questions that matter in a valid, efficient, and accessible manner. This study surveyed experts about existing (e.g., citation analysis) and new methods for monitoring EBR and collected ideas about implementing these methods. STUDY DESIGN AND SETTING: We conducted a cross-sectional study via an online survey between November 2022 and March 2023. Participants were experts from the fields of evidence synthesis and research methodology in health research. Open-ended questions were coded by recurring themes; descriptive statistics were used for quantitative questions. RESULTS: Twenty-eight expert participants suggested that citation analysis should be supplemented with content evaluation (not just what is cited but also in which context), content expert involvement, and assessment of the quality of cited systematic reviews. They also suggested that citation analysis could be facilitated with automation tools. They emphasized that EBR monitoring should be conducted by ethics committees and funding bodies before the research starts. Challenges identified for EBR implementation monitoring were resource constraints and clarity on responsibility for EBR monitoring. CONCLUSION: Ideas proposed in this study for monitoring the implementation of EBR can be used to refine methods and define responsibility but should be further explored in terms of feasibility and acceptability. Different methods may be needed to determine if the use of EBR is improving over time.
Subject(s)
Research Design , Humans , Cross-Sectional StudiesABSTRACT
BACKGROUND: The optimal dose of dexamethasone for severe/critical COVID-19 is uncertain. We compared higher versus standard doses of dexamethasone in adults with COVID-19 and hypoxia. METHODS: We searched PubMed and trial registers until 23 June 2023 for randomised clinical trials comparing higher (>6 mg) versus standard doses (6 mg) of dexamethasone in adults with COVID-19 and hypoxia. The primary outcome was mortality at 1 month. Secondary outcomes were mortality closest to 90 days; days alive without life support; and the occurrence of serious adverse events/reactions (SAEs/SARs) closest to 1 month. We assessed the risk of bias using the Cochrane RoB2 tool, risk of random errors using trial sequential analysis, and certainty of evidence using Grading of Recommendations Assessment, Development and Evaluation (GRADE). RESULTS: We included eight trials (2478 participants), of which four (1293 participants) had low risk of bias. Higher doses of dexamethasone probably resulted in little to no difference in mortality at 1 month (relative risk [RR] 0.97, 95% CI: 0.79-1.19), mortality closest to Day 90 (RR 1.01, 95% CI: 0.86-1.20), and SAEs/SARs (RR 1.00, 95% CI: 0.97-1.02). Higher doses of dexamethasone probably increased the number of days alive without invasive mechanical ventilation and circulatory support but had no effect on days alive without renal replacement therapy. CONCLUSIONS: Based on low to moderate certainty evidence, higher versus standard doses of dexamethasone probably result in little to no difference in mortality, SAEs/SARs, and days alive without renal replacement therapy, but probably increase the number of days alive without invasive mechanical ventilation and circulatory support.
Subject(s)
COVID-19 , Adult , Humans , COVID-19 Drug Treatment , Patients , Dexamethasone/adverse effects , HypoxiaABSTRACT
OBJECTIVE: The purpose of this review was to identify prognostic models for clinical application in patients with venous leg ulcers (VLUs). METHODS: Literature searches were conducted in Embase, Medline, Cochrane, and CINAHL databases from inception to December 22, 2021. Eligible studies reported prognostic models aimed at developing, validating, and adjusting multivariable prognostic models that include multiple prognostic factors combined, and that predicted clinical outcomes. Methodological quality was assessed using the CHARMS checklist and PROBAST short form questionnaire. RESULTS: Thirteen studies were identified, of which three were validation studies of previously published models, four reported derivation and validation of models, and the remainder reported derivation models only. There was substantial heterogeneity in the model characteristics, including 11 studies focused on wound healing outcomes reporting 91 different predictors. Three studies shared similar predicted outcomes, follow-up timepoint and used a Cox proportional hazards model. However, these models reported different predictor selection methods and different predictors and it was therefore not feasible to summarize performance, such as discriminative ability. CONCLUSIONS: There are no standout risk prediction models in the literature with promising clinical application for patients with VLUs. Future research should focus on developing and validating high-performing models in wider VLU populations.
Subject(s)
Varicose Ulcer , Humans , Prognosis , Varicose Ulcer/diagnosis , Varicose Ulcer/therapy , Wound HealingABSTRACT
OBJECTIVES: This umbrella review aims to quality assess published meta-analyses, conduct a de-novo meta-analysis of the available randomized control trials (RCTs), and test the hypothesis that there is a long-term difference in mortality between OSR and EVAR. METHODS: A systematic search was conducted in MEDLINE and EMBASE's bibliographic databases (June 2022). Data were extracted using standardized extraction forms. The methodological quality of publications was assessed using the ROBIS tool. Data were analyzed with 'one-stage' and 'two-stage' approaches. RESULTS: According to two-stage analysis, EVAR has significantly favorable mortality for up to four years (increasing evidence). Subsequently, until the longest available time period, there is no difference between EVAR and OSR; all the results are statistically non-significant.In one stage analysis, the Cox model demonstrated a non-significant (weak evidence) hazard ratio of 1.03 (95% confidence interval [CI]: 0.94-1.12) in favor of OSR. The best-fitting parametric model (generalized gamma), leads to an hazard ratio of 0.97 (95% CI: 0.93-1.01) in favor of EVAR, with the results approaching significance (weak evidence). CONCLUSION: The results of this umbrella systematic review and meta-analysis failed to demonstrate any difference in long-term mortality following planned EVAR, compared with OSR of infrarenal AAA.
Subject(s)
Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/adverse effects , Endovascular Procedures/methods , Postoperative Complications , Risk Factors , Treatment OutcomeABSTRACT
OBJECTIVE: To identify demographic, premorbid and injury-related factors, or biomarkers associated with long-term (≥3 months) adverse outcomes in children after mild traumatic brain injury (mTBI). DESIGN: Scoping review of literature. PATIENTS: Children and adolescents with mTBI. RISK FACTORS: Any demographic, premorbid and injury-related factors, or biomarkers were included. We excluded genetic and treatment-related factors. MAIN OUTCOME MEASURES: Postconcussion syndrome (PCS), recovery. RESULTS: Seventy-three publications were included, reporting 12 long-term adverse outcomes, including PCS in 12 studies and recovery in 29 studies. Additional outcomes studied were symptom scores/severity (n=22), quality of life (n=9) and cognitive function (n=9). Forty-nine risk factors were identified across studies. Risk factors most often assessed were sex (n=28), followed by age (n=23), injury mechanism = (n=22) and prior mTBI (n=18). The influence of these and other risk factors on outcomes of mTBI were inconsistent across the reviewed literature. CONCLUSIONS: The most researched risk factors are sex, age and mechanism of injury, but their effects have been estimated inconsistently and did not show a clear pattern. The most studied outcomes are recovery patterns and symptom severity. However, these may not be the most important outcomes for clinicians and patients. Future primary studies in this area should focus on patient-important outcomes. Population-based prospective studies are needed that address prespecified hypotheses on the relationship of risk factors with given outcomes to enable reliable prediction of long-term adverse outcomes for childhood mTBI.
Subject(s)
Brain Concussion , Post-Concussion Syndrome , Adolescent , Humans , Child , Brain Concussion/complications , Brain Concussion/diagnosis , Quality of Life , Post-Concussion Syndrome/etiology , Post-Concussion Syndrome/complications , Risk Factors , BiomarkersABSTRACT
In this experimental study, picosecond laser treatment was performed on a nickel-based superalloy Nimonic 263, aiming to investigate the surface effects induced by irradiation in different atmospheric conditions and, concerning changes in surface composition, regarding the possibility for improvement of its functionality. Besides the varying laser parameters, such as a number of pulses and pulse energy, environmental conditions are also varied. All surface modifications were carried out in standard laboratory conditions and a nitrogen- and argon-rich atmosphere. The resulting topography effects depend on the specific laser treatment and could be categorized as increased roughness, crater formation, and formation of the laser-induced periodic surface structures (LIPSS). Changes in the chemical surface composition are distinguished as the potential formation of the protective oxides/nitrides on the sample surface. Numerous characterization techniques analyse the resulting effects on the topography and surface parameters. The multi-response parametric optimization of the picosecond laser process was performed using an advanced statistical method based on Taguchi's robust parameter design. Finally, the optimal parameter conditions for Nimonic 263 modification are suggested.
ABSTRACT
BACKGROUND: Paediatric abusive head trauma (AHT) occurs in young children due to violent shaking or blunt impact. Educational and behavioural programmes modifying parent/infant interactions may aid primary prevention. This systematic review aims to assess the effectiveness of such interventions to prevent AHT in infants. METHODS: We searched Embase, MEDLINE, PsycINFO, The Cochrane library, CINAHL databases and trial registries to September 2021, for studies assessing the effectiveness of educational and behavioural interventions in preventing AHT. Eligible interventions had to include messaging about avoiding or dangers of infant shaking. Randomised controlled trials (RCTs) reporting results for primary (AHT, infant shaking) or secondary outcomes (including parental responses to infant crying, mental wellbeing), and non-randomised studies (NRSs) reporting primary outcomes were included. Evidence from combinable studies was synthesised using random-effects meta-analyses. Certainty of evidence was assessed using GRADE framework. PROSPERO registration CRD42020195644. FINDINGS: Of 25 identified studies, 16 were included in meta-analyses. Five NRSs reported results for AHT, of which four were meta-analysed (summary odds ratio [OR] 0.95, 95 % confidence intervals [CI] 0.80-1.13). Two studies assessed self-reported shaking (one cluster-RCT, OR 0.11, 95 % CI 0.02-0.53; one cohort study, OR 0.36, 95 % CI 0.20-0.64, not pooled). Meta-analyses of secondary outcomes demonstrated marginal improvements in parental response to inconsolable crying (summary mean difference 1.58, 95 % CI 0.11-3.06, on a 100-point scale) and weak evidence that interventions increased walking away from crying infants (summary incidence rate ratio 1.52, 95 % CI 0.94-2.45). No intervention effects were found in meta-analyses of parental mental wellbeing or other responses to crying. INTERPRETATION: Low certainty evidence suggests that educational programmes for AHT prevention are not effective in preventing AHT. There is low to moderate certainty evidence that educational interventions have no effect or only marginally improve some parental responses to infant crying.
Subject(s)
Child Abuse , Craniocerebral Trauma , Infant , Child , Humans , Child, Preschool , Craniocerebral Trauma/epidemiology , Craniocerebral Trauma/prevention & control , Parents , Child Abuse/prevention & control , Crying , IncidenceABSTRACT
INTRODUCTION: Burns affect 11 million people globally and can result in long-term disability with substantial associated healthcare costs. There is limited research funding to support trials to provide evidence for clinical decision-making. Research prioritisation ensures that research focuses on the topics most important to stakeholders, addressing issues of research waste and evidence gaps. The aim of this project is to agree the global top 10 research priorities important to international patients, carers and clinicians from all income status countries. METHODS AND ANALYSIS: The Global Burns Research Priority Setting Partnership will use James Lind Alliance methods to establish the top 10 research priorities in global burns care. An initial international online multilingual survey will collect candidate research priorities from stakeholders. To increase equity in participation, the survey will also be available via the social media app WhatsApp. Additionally, interviews will be conducted. Data will be analysed to identify and collate research questions and to verify that the priorities are true clinical uncertainties. This list will then be ranked by stakeholders in order of importance via a second online survey. Finally, a consensus meeting will identify the top 10 research priorities. ETHICS AND DISSEMINATION: The University of Bristol Medical School Faculty Ethical Committee has approved this project. Research into burn care should be prioritised to ensure that funding is focused where most needed. This should be undertaken internationally, to ensure inclusion of the views of professionals and patients from lower income countries, where the incidence of thermal burns is highest. The involvement of the James Lind Alliance will ensure that the methodology is robust and that the patient voice is heard. The final top 10 priorities will be disseminated to funders, governments and researchers internationally to inform future global burns research.
Subject(s)
Biomedical Research , Burns , Burns/therapy , Caregivers , Consensus , Humans , Surveys and QuestionnairesABSTRACT
Ribavirin has been used widely to treat Lassa fever in West Africa since the 1980s. However, few studies have systematically appraised the evidence for its use. We conducted a systematic review of published and unpublished literature retrieved from electronic databases and gray literature from inception to March 8, 2022. We identified 13 studies of the comparative effectiveness of ribavirin versus no ribavirin treatment on mortality outcomes, including unpublished data from a study in Sierra Leone provided through a US Freedom of Information Act request. Although ribavirin was associated with decreased mortality rates, results of these studies were at critical or serious risk for bias when appraised using the ROBINS-I tool. Important risks for bias related to lack of control for confounders, immortal time bias, and missing outcome data. Robust evidence supporting the use of ribavirin in Lassa fever is lacking. Well-conducted clinical trials to elucidate the effectiveness of ribavirin for Lassa fever are needed.