Health technology assessment最新文献

{"title":"Use of selective gut decontamination in critically ill children: PICnIC a pilot RCT and mixed-methods study.","authors":"Alanna Brown, Paloma Ferrando-Vivas, Mariana Popa, Gema Milla de la Fuente, John Pappachan, Brian H Cuthbertson, Laura Drikite, Richard Feltbower, Theodore Gouliouris, Isobel Sale, Robert Shulman, Lyvonne N Tume, John Myburgh, Kerry Woolfall, David A Harrison, Paul R Mouncey, Kathryn Rowan, Nazima Pathan","doi":"10.3310/HDKV1008","DOIUrl":"10.3310/HDKV1008","url":null,"abstract":"<p><strong>Background: </strong>Healthcare-associated infections are a major cause of morbidity and mortality in critically ill children. In adults, data suggest the use of selective decontamination of the digestive tract may reduce the incidence of healthcare-associated infections. Selective decontamination of the digestive tract has not been evaluated in the paediatric intensive care unit population.</p><p><strong>Objectives: </strong>To determine the feasibility of conducting a multicentre, cluster-randomised controlled trial in critically ill children comparing selective decontamination of the digestive tract with standard infection control.</p><p><strong>Design: </strong>Parallel-group pilot cluster-randomised controlled trial with an integrated mixed-methods study.</p><p><strong>Setting: </strong>Six paediatric intensive care units in England.</p><p><strong>Participants: </strong>Children (> 37 weeks corrected gestational age, up to 16 years) requiring mechanical ventilation expected to last for at least 48 hours were eligible for the PICnIC pilot cluster-randomised controlled trial. During the ecology periods, all children admitted to the paediatric intensive care units were eligible. Parents/legal guardians of recruited patients and healthcare professionals working in paediatric intensive care units were eligible for inclusion in the mixed-methods study.</p><p><strong>Interventions: </strong>The interventions in the PICnIC pilot cluster-randomised controlled trial included administration of selective decontamination of the digestive tract as oro-pharyngeal paste and as a suspension given by enteric tube during the period of mechanical ventilation.</p><p><strong>Main outcome measures: </strong>The decision as to whether a definitive cluster-randomised controlled trial is feasible is based on multiple outcomes, including (but not limited to): (1) willingness and ability to recruit eligible patients; (2) adherence to the selective decontamination of the digestive tract intervention; (3) acceptability of the definitive cluster-randomised controlled trial; (4) estimation of recruitment rate; and (5) understanding of potential clinical and ecological outcome measures.</p><p><strong>Results: </strong>A total of 368 children (85% of all those who were eligible) were enrolled in the PICnIC pilot cluster-randomised controlled trial across six paediatric intensive care units: 207 in the baseline phase (Period One) and 161 in the intervention period (Period Two). In sites delivering selective decontamination of the digestive tract, the majority (98%) of children received at least one dose of selective decontamination of the digestive tract, and of these, 68% commenced within the first 6 hours. Consent for the collection of additional swabs was low (44%), though data completeness for potential outcomes, including microbiology data from routine clinical swab testing, was excellent. Recruited children were representative of the wider paediatric intensiv","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 8","pages":"1-84"},"PeriodicalIF":3.5,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017160/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139989802","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and evaluation of a de-escalation training intervention in adult acute and forensic units: the EDITION systematic review and feasibility trial.","authors":"Owen Price, Cat Papastavrou Brooks, Isobel Johnston, Peter McPherson, Helena Goodman, Andrew Grundy, Lindsey Cree, Zahra Motala, Jade Robinson, Michael Doyle, Nicholas Stokes, Christopher J Armitage, Elizabeth Barley, Helen Brooks, Patrick Callaghan, Lesley-Anne Carter, Linda M Davies, Richard J Drake, Karina Lovell, Penny Bee","doi":"10.3310/FGGW6874","DOIUrl":"10.3310/FGGW6874","url":null,"abstract":"<p><strong>Background: </strong>Containment (e.g. physical restraint and seclusion) is used frequently in mental health inpatient settings. Containment is associated with serious psychological and physical harms. De-escalation (psychosocial techniques to manage distress without containment) is recommended to manage aggression and other unsafe behaviours, for example self-harm. All National Health Service staff are trained in de-escalation but there is little to no evidence supporting training's effectiveness.</p><p><strong>Objectives: </strong>Objectives were to: (1) qualitatively investigate de-escalation and identify barriers and facilitators to use across the range of adult acute and forensic mental health inpatient settings; (2) co-produce with relevant stakeholders an intervention to enhance de-escalation across these settings; (3) evaluate the intervention's preliminary effect on rates of conflict (e.g. violence, self-harm) and containment (e.g. seclusion and physical restraint) and understand barriers and facilitators to intervention effects.</p><p><strong>Design: </strong>Intervention development informed by Experience-based Co-design and uncontrolled pre and post feasibility evaluation. Systematic reviews and qualitative interviews investigated contextual variation in use and effects of de-escalation. Synthesis of this evidence informed co-design of an intervention to enhance de-escalation. An uncontrolled feasibility trial of the intervention followed. Clinical outcome data were collected over 24 weeks including an 8-week pre-intervention phase, an 8-week embedding and an 8-week post-intervention phase.</p><p><strong>Setting: </strong>Ten inpatient wards (including acute, psychiatric intensive care, low, medium and high secure forensic) in two United Kingdom mental health trusts.</p><p><strong>Participants: </strong>In-patients, clinical staff, managers, carers/relatives and training staff in the target settings.</p><p><strong>Interventions: </strong>Enhancing de-escalation techniques in adult acute and forensic units: Development and evaluation of an evidence-based training intervention (EDITION) interventions included de-escalation training, two novel models of reflective practice, post-incident debriefing and feedback on clinical practice, collaborative prescribing and ward rounds, practice changes around admission, shift handovers and the social and physical environment, and sensory modulation and support planning to reduce patient distress.</p><p><strong>Main outcome measures: </strong>Outcomes measured related to feasibility (recruitment and retention, completion of outcome measures), training outcomes and clinical and safety outcomes. Conflict and containment rates were measured via the Patient-Staff Conflict Checklist. Clinical outcomes were measured using the Attitudes to Containment Measures Questionnaire, Attitudes to Personality Disorder Questionnaire, Violence Prevention Climate Scale, Capabilities, Opportunities, and Motiv","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 3","pages":"1-120"},"PeriodicalIF":3.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017147/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139722314","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Abrocitinib, tralokinumab and upadacitinib for treating moderate-to-severe atopic dermatitis.","authors":"Steven J Edwards, Charlotta Karner, Tracey Jhita, Samantha Barton, Gemma Marceniuk, Zenas Z N Yiu, Miriam Wittmann","doi":"10.3310/LEXB9006","DOIUrl":"10.3310/LEXB9006","url":null,"abstract":"<p><strong>Background: </strong>Atopic dermatitis is a chronic relapsing inflammatory skin condition. One of the most common skin disorders in children, atopic dermatitis typically manifests before the age of 5 years, but it can develop at any age. Atopic dermatitis is characterised by dry, inflamed skin accompanied by intense itchiness (pruritus).</p><p><strong>Objectives: </strong>To appraise the clinical and cost effectiveness of abrocitinib, tralokinumab and upadacitinib within their marketing authorisations as alternative therapies for treating moderate-to-severe atopic dermatitis compared to systemic immunosuppressants (first-line ciclosporin A or second-line dupilumab and baricitinib).</p><p><strong>Data sources: </strong>Studies were identified from an existing systematic review (search date 2019) and update searches of electronic databases (MEDLINE, EMBASE, CENTRAL) to November 2021, from bibliographies of retrieved studies, clinical trial registers and evidence provided by the sponsoring companies of the treatments under review.</p><p><strong>Methods: </strong>A systematic review of the clinical effectiveness literature was carried out and a network meta-analysis undertaken for adults and adolescents at different steps of the treatment pathway. The primary outcome of interest was a combined response of Eczema Area and Severity Index 50 + Dermatology Life Quality Index ≥ 4; where this was consistently unavailable for a step in the pathway, an analysis of Eczema Area and Severity Index 75 was conducted. A de novo economic model was developed to assess cost effectiveness from the perspective of the National Health Service in England. The model structure was informed through systematic review of the economic literature and by consulting clinical experts. Effectiveness data were obtained from the network meta-analysis. Costs and utilities were obtained from the evidence provided by sponsoring companies and standard UK sources.</p><p><strong>Results: </strong>Network meta-analyses indicate that abrocitinib 200 mg and upadacitinib 30 mg may be more effective, and tralokinumab may be less effective than dupilumab and baricitinib as second-line systemic therapies. Abrocitinib 100 mg and upadacitinib 15 mg have a more similar effectiveness to dupilumab. Upadacitinib 30 and 15 mg are likely to be more effective than ciclosporin A as a first-line therapy. Upadacitinib 15 mg, abrocitinib 200 and 100 mg may be more effective than dupilumab in adolescents. The cost effectiveness of abrocitinib and upadacitinib for both doses is dependent on the subgroup of interest. Tralokinumab can be considered cost-effective as a second-line systemic therapy owing to greater cost savings per quality-adjusted life-year lost.</p><p><strong>Conclusions: </strong>The primary strength of the analysis of the three new drugs compared with current practice for each of the subpopulations is the consistent approach to the assessment of clinical and cost effectiveness. Howeve","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 4","pages":"1-113"},"PeriodicalIF":3.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017148/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139722324","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Undertaking Studies Within A Trial to evaluate recruitment and retention strategies for randomised controlled trials: lessons learnt from the PROMETHEUS research programme.","authors":"Adwoa Parker, Catherine Arundel, Laura Clark, Elizabeth Coleman, Laura Doherty, Catherine Elizabeth Hewitt, David Beard, Peter Bower, Cindy Cooper, Lucy Culliford, Declan Devane, Richard Emsley, Sandra Eldridge, Sandra Galvin, Katie Gillies, Alan Montgomery, Christopher J Sutton, Shaun Treweek, David J Torgerson","doi":"10.3310/HTQW3107","DOIUrl":"10.3310/HTQW3107","url":null,"abstract":"<p><strong>Background: </strong>Randomised controlled trials ('trials') are susceptible to poor participant recruitment and retention. Studies Within A Trial are the strongest methods for testing the effectiveness of strategies to improve recruitment and retention. However, relatively few of these have been conducted.</p><p><strong>Objectives: </strong>PROMoting THE Use of Studies Within A Trial aimed to facilitate at least 25 Studies Within A Trial evaluating recruitment or retention strategies. We share our experience of delivering the PROMoting THE Use of Studies Within A Trial programme, and the lessons learnt for undertaking randomised Studies Within A Trial.</p><p><strong>Design: </strong>A network of 10 Clinical Trials Units and 1 primary care research centre committed to conducting randomised controlled Studies Within A Trial of recruitment and/or retention strategies was established. Promising recruitment and retention strategies were identified from various sources including Cochrane systematic reviews, the Study Within A Trial Repository, and existing prioritisation exercises, which were reviewed by patient and public members to create an initial priority list of seven recruitment and eight retention interventions. Host trial teams could apply for funding and receive support from the PROMoting THE Use of Studies Within A Trial team to undertake Studies Within A Trial. We also tested the feasibility of undertaking co-ordinated Studies Within A Trial, across multiple host trials simultaneously.</p><p><strong>Setting: </strong>Clinical trials unit-based trials recruiting or following up participants in any setting in the United Kingdom were eligible.</p><p><strong>Participants: </strong>Clinical trials unit-based teams undertaking trials in any clinical context in the United Kingdom.</p><p><strong>Interventions: </strong>Funding of up to £5000 and support from the PROMoting THE Use of Studies Within A Trial team to design, implement and report Studies Within A Trial.</p><p><strong>Main outcome measures: </strong>Number of host trials funded.</p><p><strong>Results: </strong>Forty-two Studies Within A Trial were funded (31 host trials), across 12 Clinical Trials Units. The mean cost of a Study Within A Trial was £3535. Twelve Studies Within A Trial tested the same strategy across multiple host trials using a co-ordinated Study Within A Trial design, and four used a factorial design. Two recruitment and five retention strategies were evaluated in more than one host trial. PROMoting THE Use of Studies Within A Trial will add 18% more Studies Within A Trial to the Cochrane systematic review of recruitment strategies, and 79% more Studies Within A Trial to the Cochrane review of retention strategies. For retention, we found that pre-notifying participants by card, letter or e-mail before sending questionnaires was effective, as was the use of pens, and sending personalised text messages to improve questionnaire response. We highlight key lesson","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 2","pages":"1-114"},"PeriodicalIF":3.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017159/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139702330","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical and cost-effectiveness of an adapted intervention for preschoolers with moderate to severe intellectual disabilities displaying behaviours that challenge: the EPICC-ID RCT.","authors":"Tamara Ondruskova, Rachel Royston, Michael Absoud, Gareth Ambler, Chen Qu, Jacqueline Barnes, Rachael Hunter, Monica Panca, Marinos Kyriakopoulos, Kate Oulton, Eleni Paliokosta, Aditya Narain Sharma, Vicky Slonims, Una Summerson, Alastair Sutcliffe, Megan Thomas, Brindha Dhandapani, Helen Leonard, Angela Hassiotis","doi":"10.3310/JKTY6144","DOIUrl":"10.3310/JKTY6144","url":null,"abstract":"<p><strong>Background: </strong>Stepping Stones Triple P is an adapted intervention for parents of young children with developmental disabilities who display behaviours that challenge, aiming at teaching positive parenting techniques and promoting a positive parent-child relationship.</p><p><strong>Objective: </strong>To evaluate the clinical and cost-effectiveness of level 4 Stepping Stones Triple P in reducing behaviours that challenge in children with moderate to severe intellectual disabilities.</p><p><strong>Design, setting, participants: </strong>A parallel two-arm pragmatic multisite single-blind randomised controlled trial recruited a total of 261 dyads (parent and child). The children were aged 30-59 months and had moderate to severe intellectual disabilities. Participants were randomised, using a 3 : 2 allocation ratio, into the intervention arm (Stepping Stones Triple P; <i>n</i> = 155) or treatment as usual arm (<i>n</i> = 106). Participants were recruited from four study sites in Blackpool, North and South London and Newcastle.</p><p><strong>Intervention: </strong>Level 4 Stepping Stones Triple P consists of six group sessions and three individual phone or face-to-face contacts over 9 weeks. These were changed to remote sessions after 16 March 2020 due to the coronavirus disease 2019 pandemic.</p><p><strong>Main outcome measure: </strong>The primary outcome measure was the parent-reported Child Behaviour Checklist, which assesses the severity of behaviours that challenge.</p><p><strong>Results: </strong>We found a small non-significant difference in the mean Child Behaviour Checklist scores (-4.23, 95% CI -9.98 to 1.52, <i>p</i> = 0.146) in the intervention arm compared to treatment as usual at 12 months. Per protocol and complier average causal effect sensitivity analyses, which took into consideration the number of sessions attended, showed the Child Behaviour Checklist mean score difference at 12 months was lower in the intervention arm by -10.77 (95% CI -19.12 to -2.42, <i>p</i> = 0.014) and -11.53 (95% CI -26.97 to 3.91, <i>p</i> = 0.143), respectively. The Child Behaviour Checklist mean score difference between participants who were recruited before and after the coronavirus disease 2019 pandemic was estimated as -7.12 (95% CI -13.44 to -0.81) and 7.61 (95% CI -5.43 to 20.64), respectively (<i>p</i> = 0.046), suggesting that any effect pre-pandemic may have reversed during the pandemic. There were no differences in all secondary measures. Stepping Stones Triple P is probably value for money to deliver (-£1057.88; 95% CI -£3218.6 to -£46.67), but decisions to roll this out as an alternative to existing parenting interventions or treatment as usual may be dependent on policymaker willingness to invest in early interventions to reduce behaviours that challenge. Parents reported the intervention boosted their confidence and skills, and the group format enabled them to learn from others and benefit from peer support. There were 20 s","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 6","pages":"1-94"},"PeriodicalIF":3.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017145/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139702331","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A tailored psychological intervention for anxiety and depression management in people with chronic obstructive pulmonary disease: TANDEM RCT and process evaluation.","authors":"Ratna Sohanpal, Hilary Pinnock, Liz Steed, Karen Heslop-Marshall, Moira J Kelly, Claire Chan, Vari Wileman, Amy Barradell, Clarisse Dibao-Dina, Paulino Font Gilabert, Andy Healey, Richard Hooper, Kristie-Marie Mammoliti, Stefan Priebe, Mike Roberts, Vickie Rowland, Sarah Waseem, Sally Singh, Melanie Smuk, Martin Underwood, Patrick White, Nahel Yaziji, Stephanie Jc Taylor","doi":"10.3310/PAWA7221","DOIUrl":"10.3310/PAWA7221","url":null,"abstract":"<p><strong>Background: </strong>People with chronic obstructive pulmonary disease have high levels of anxiety and depression, which is associated with increased morbidity and poor uptake of effective treatments, such as pulmonary rehabilitation. Cognitive-behavioural therapy improves mental health of people with long-term conditions and could potentially increase uptake of pulmonary rehabilitation, enabling synergies that could enhance the mental health of people with chronic obstructive pulmonary disease.</p><p><strong>Aim: </strong>Our aim was to develop and evaluate the clinical effectiveness and cost effectiveness of a tailored cognitive-behavioural approach intervention, which links into, and optimises the benefits of, routine pulmonary rehabilitation.</p><p><strong>Design: </strong>We carried out a pragmatic multicentre randomised controlled trial using a 1.25 : 1 ratio (intervention : control) with a parallel process evaluation, including assessment of fidelity.</p><p><strong>Setting: </strong>Twelve NHS trusts and five Clinical Commissioning Groups in England were recruited into the study. The intervention was delivered in participant's own home or at a local NHS facility, and by telephone.</p><p><strong>Participants: </strong>Between July 2017 and March 2020 we recruited adults with moderate/very severe chronic obstructive pulmonary disease and mild/moderate anxiety and/or depression, meeting eligibility criteria for assessment for pulmonary rehabilitation. Carers of participants were invited to participate.</p><p><strong>Intervention: </strong>The cognitive-behavioural approach intervention (i.e. six to eight 40- to 60-minute sessions plus telephone support throughout pulmonary rehabilitation) was delivered by 31 trained respiratory healthcare professionals to participants prior to commencing pulmonary rehabilitation. Usual care included routine pulmonary rehabilitation referral.</p><p><strong>Main outcome measures: </strong>Co-primary outcomes were Hospital Anxiety and Depression Scale - anxiety and Hospital Anxiety and Depression Scale - depression at 6 months post randomisation. Secondary outcomes at 6 and 12 months included health-related quality of life, smoking status, uptake of pulmonary rehabilitation and healthcare use.</p><p><strong>Results: </strong>We analysed results from 423 randomised participants (intervention, <i>n</i> = 242; control, <i>n</i> = 181). Forty-three carers participated. Follow-up at 6 and 12 months was 93% and 82%, respectively. Despite good fidelity for intervention delivery, mean between-group differences in Hospital Anxiety and Depression Scale at 6 months ruled out clinically important effects (Hospital Anxiety and Depression Scale - anxiety mean difference -0.60, 95% confidence interval -1.40 to 0.21; Hospital Anxiety and Depression Scale - depression mean difference -0.66, 95% confidence interval -1.39 to 0.07), with similar results at 12 months. There were no between-group differences in any of the ","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 1","pages":"1-129"},"PeriodicalIF":3.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017633/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139478396","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Strategies used for childhood chronic functional constipation: the SUCCESS evidence synthesis.","authors":"Alex Todhunter-Brown, Lorna Booth, Pauline Campbell, Brenda Cheer, Julie Cowie, Andrew Elders, Suzanne Hagen, Karen Jankulak, Helen Mason, Clare Millington, Margaret Ogden, Charlotte Paterson, Davina Richardson, Debs Smith, Jonathan Sutcliffe, Katie Thomson, Claire Torrens, Doreen McClurg","doi":"10.3310/PLTR9622","DOIUrl":"10.3310/PLTR9622","url":null,"abstract":"<p><strong>Background: </strong>Up to 30% of children have constipation at some stage in their life. Although often short-lived, in one-third of children it progresses to chronic functional constipation, potentially with overflow incontinence. Optimal management strategies remain unclear.</p><p><strong>Objective: </strong>To determine the most effective interventions, and combinations and sequences of interventions, for childhood chronic functional constipation, and understand how they can best be implemented.</p><p><strong>Methods: </strong>Key stakeholders, comprising two parents of children with chronic functional constipation, two adults who experienced childhood chronic functional constipation and four health professional/continence experts, contributed throughout the research. We conducted pragmatic mixed-method reviews. For all reviews, included studies focused on any interventions/strategies, delivered in any setting, to improve any outcomes in children (0-18 years) with a clinical diagnosis of chronic functional constipation (excluding studies of diagnosis/assessment) included. Dual reviewers applied inclusion criteria and assessed risk of bias. One reviewer extracted data, checked by a second reviewer. <b>Scoping review:</b> We systematically searched electronic databases (including Medical Literature Analysis and Retrieval System Online, Excerpta Medica Database, Cumulative Index to Nursing and Allied Health Literature) (January 2011 to March 2020) and grey literature, including studies (any design) reporting any intervention/strategy. Data were coded, tabulated and mapped. Research quality was not evaluated. <b>Systematic reviews of the evidence of effectiveness:</b> For each different intervention, we included existing systematic reviews judged to be low risk of bias (using the Risk of Bias Assessment Tool for Systematic Reviews), updating any meta-analyses with new randomised controlled trials. Where there was no existing low risk of bias systematic reviews, we included randomised controlled trials and other primary studies. The risk of bias was judged using design-specific tools. Evidence was synthesised narratively, and a process of considered judgement was used to judge certainty in the evidence as high, moderate, low, very low or insufficient evidence. <b>Economic synthesis:</b> Included studies (any design, English-language) detailed intervention-related costs. Studies were categorised as cost-consequence, cost-effectiveness, cost-utility or cost-benefit, and reporting quality evaluated using the consensus health economic criteria checklist. <b>Systematic review of implementation factors:</b> Included studies reported data relating to implementation barriers or facilitators. Using a best-fit framework synthesis approach, factors were synthesised around the consolidated framework for implementation research domains.</p><p><strong>Results: </strong>Stakeholders prioritised outcomes, developed a model which informed evidence synth","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 5","pages":"1-266"},"PeriodicalIF":3.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017632/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139722325","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical outcomes and adverse events of bariatric surgery in adults with severe obesity in Scotland: the SCOTS observational cohort study.","authors":"Ruth M Mackenzie, Abdulmajid Ali, Duff Bruce, Julie Bruce, Ian Ford, Nicola Greenlaw, Eleanor Grieve, Mike Lean, Robert S Lindsay, Joanne O'Donnell, Naveed Sattar, Sally Stewart, Jennifer Logue","doi":"10.3310/UNAW6331","DOIUrl":"10.3310/UNAW6331","url":null,"abstract":"<p><strong>Background: </strong>Bariatric surgery is a common procedure worldwide for the treatment of severe obesity and associated comorbid conditions but there is a lack of evidence as to medium-term safety and effectiveness outcomes in a United Kingdom setting.</p><p><strong>Objective: </strong>To establish the clinical outcomes and adverse events of different bariatric surgical procedures, their impact on quality of life and the effect on comorbidities.</p><p><strong>Design: </strong>Prospective observational cohort study.</p><p><strong>Setting: </strong>National Health Service secondary care and private practice in Scotland, United Kingdom.</p><p><strong>Participants: </strong>Adults (age >16 years) undergoing their first bariatric surgery procedure.</p><p><strong>Main outcome measures: </strong>Change in weight, hospital length of stay, readmission and reoperation rate, mortality, diabetes outcomes (HbA1c, medications), quality of life, anxiety, depression.</p><p><strong>Data sources: </strong>Patient-reported outcome measures, hospital records, national electronic health records (Scottish Morbidity Record 01, Scottish Care Information Diabetes, National Records Scotland, Prescription Information System).</p><p><strong>Results: </strong>Between December 2013 and February 2017, 548 eligible patients were approached and 445 participants were enrolled in the study. Of those, 335 had bariatric surgery and 1 withdrew from the study. Mean age was 46.0 (9.2) years, 74.7% were female and the median body mass index was 46.4 (42.4; 52.0) kg/m<sup>2</sup>. Weight was available for 128 participants at 3 years: mean change was -19.0% (±14.1) from the operation and -24.2% (±12.8) from the start of the preoperative weight-management programme. One hundred and thirty-nine (41.4%) participants were readmitted to hospital in the same or subsequent 35 months post surgery, 18 (5.4% of the operated cohort) had a reoperation or procedure considered to be related to bariatric surgery gastrointestinal complications or revisions. Fewer than five participants (<2%) died during follow-up. HbA1c was available for 93/182 and diabetes medications for 139/182 participants who had type 2 diabetes prior to surgery; HbA1c mean change was -5.72 (±16.71) (<i>p</i> = 0.001) mmol/mol and 65.5% required no diabetes medications (<i>p</i> < 0.001) at 3 years post surgery. Physical quality of life, available for 101/335 participants, improved in the 3 years post surgery, mean change in Rand 12-item Short Form Survey physical component score 8.32 (±8.95) (<i>p</i> < 0.001); however, there was no change in the prevalence of anxiety or depression.</p><p><strong>Limitations: </strong>Due to low numbers of bariatric surgery procedures in Scotland, recruitment was stopped before achieving the intended 2000 participants and follow-up was reduced from 10 years to 3 years.</p><p><strong>Conclusions: </strong>Bariatric surgery is a safe and effective treatment for obesity. Patients in Scotl","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 7","pages":"1-115"},"PeriodicalIF":3.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017628/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139722326","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The potential impact of policies and structural interventions in reducing cardiovascular disease and mortality: a systematic review of simulation-based studies.","authors":"Olalekan A Uthman, Rachel Court, Seun Anjorin, Jodie Enderby, Lena Al-Khudairy, Chidozie Nduka, Hema Mistry, G J Melendez-Torres, Sian Taylor-Phillips, Aileen Clarke","doi":"10.3310/NMFG0214","DOIUrl":"https://doi.org/10.3310/NMFG0214","url":null,"abstract":"<p><strong>Background: </strong>The aim of the study was to investigate the potential effect of different structural interventions for preventing cardiovascular disease.</p><p><strong>Methods: </strong>Medline and EMBASE were searched for peer-reviewed simulation-based studies of structural interventions for prevention of cardiovascular disease. We performed a systematic narrative synthesis.</p><p><strong>Results: </strong>A total of 54 studies met the inclusion criteria. Diet, nutrition, tobacco and alcohol control and other programmes are among the policy simulation models explored. Food tax and subsidies, healthy food and lifestyles policies, palm oil tax, processed meat tax, reduction in ultra-processed foods, supplementary nutrition assistance programmes, stricter food policy and subsidised community-supported agriculture were among the diet and nutrition initiatives. Initiatives to reduce tobacco and alcohol use included a smoking ban, a national tobacco control initiative and a tax on alcohol. Others included the NHS Health Check, WHO 25 × 25 and air quality management policy.</p><p><strong>Future work and limitations: </strong>There is significant heterogeneity in simulation models, making comparisons of output data impossible. While policy interventions typically include a variety of strategies, none of the models considered possible interrelationships between multiple policies or potential interactions. Research that investigates dose-response interactions between numerous modifications as well as longer-term clinical outcomes can help us better understand the potential impact of policy-level interventions.</p><p><strong>Conclusions: </strong>The reviewed studies underscore the potential of structural interventions in addressing cardiovascular diseases. Notably, interventions in areas such as diet, tobacco, and alcohol control demonstrate a prospective decrease in cardiovascular incidents. However, to realize the full potential of such interventions, there is a pressing need for models that consider the interplay and cumulative impacts of multiple policies. Rigorous research into holistic and interconnected interventions will pave the way for more effective policy strategies in the future.</p><p><strong>Study registration: </strong>The study is registered as PROSPERO CRD42019154836.</p><p><strong>Funding: </strong>This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 17/148/05.</p>","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"1-32"},"PeriodicalIF":3.6,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138884848","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Techniques to increase lumbar puncture success in newborn babies: the NeoCLEAR RCT.","authors":"Charles C Roehr, Andrew Sj Marshall, Alexandra Scrivens, Manish Sadarangani, Rachel Williams, Jean Yong, Louise Linsell, Virginia Chiocchia, Jennifer L Bell, Caz Stokes, Patricia Santhanadass, Ian Nicoll, Eleri Adams, Andrew King, David Murray, Ursula Bowler, Kayleigh Stanbury, Edmund Juszczak","doi":"10.3310/THJY0671","DOIUrl":"10.3310/THJY0671","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Lumbar puncture is an essential tool for diagnosing meningitis. Neonatal lumbar puncture, although frequently performed, has low success rates (50-60%). Standard technique includes lying infants on their side and removing the stylet 'late', that is, after the needle is thought to have entered the cerebrospinal fluid. Modifications to this technique include holding infants in the sitting position and removing the stylet 'early', that is, following transection of the skin. To the best of our knowledge, modified techniques have not previously been tested in adequately powered trials.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;The aim of the Neonatal Champagne Lumbar punctures Every time - An RCT (NeoCLEAR) trial was to compare two modifications to standard lumbar puncture technique, that is, use of the lying position rather than the sitting position and of 'early' rather than 'late' stylet removal, in terms of success rates and short-term clinical, resource and safety outcomes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This was a multicentre 2 × 2 factorial pragmatic non-blinded randomised controlled trial. Infants requiring lumbar puncture (with a working weight ≥ 1000 g and corrected gestational age from 27&lt;sup&gt;+0&lt;/sup&gt; to 44&lt;sup&gt;+0&lt;/sup&gt; weeks), and whose parents provided written consent, were randomised by web-based allocation to lumbar puncture (1) in the sitting or lying position and (2) with early or late stylet removal. The trial was powered to detect a 10% absolute risk difference in the primary outcome, that is, the percentage of infants with a successful lumbar puncture (cerebrospinal fluid containing &lt; 10,000 red cells/mm&lt;sup&gt;3&lt;/sup&gt;). The primary outcome was analysed by modified intention to treat.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Of 1082 infants randomised (sitting with early stylet removal, &lt;i&gt;n&lt;/i&gt; = 275; sitting with late stylet removal, &lt;i&gt;n&lt;/i&gt; = 271; lying with early stylet removal, &lt;i&gt;n&lt;/i&gt; = 274; lying with late stylet removal, &lt;i&gt;n&lt;/i&gt; = 262), 1076 were followed up until discharge. Most infants were term born (950/1076, 88.3%) and were aged &lt; 3 days (936/1076, 87.0%) with a working weight &gt; 2.5 kg (971/1076, 90.2%). Baseline characteristics were balanced across groups. In terms of the primary outcome, the sitting position was significantly more successful than lying [346/543 (63.7%) vs. 307/533 (57.6%), adjusted risk ratio 1.10 (95% confidence interval 1.01 to 1.21); &lt;i&gt;p&lt;/i&gt; = 0.029; number needed to treat = 16 (95% confidence interval 9 to 134)]. There was no significant difference in the primary outcome between early stylet removal and late stylet removal [338/545 (62.0%) vs. 315/531 (59.3%), adjusted risk ratio 1.04 (95% confidence interval 0.94 to 1.15); &lt;i&gt;p&lt;/i&gt; = 0.447]. Resource consumption was similar in all groups, and all techniques were well tolerated and safe.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Limitations: &lt;/strong&gt;This trial predominantly recruited term-born infants who were &lt; 3 days old, with working weights &gt; 2.5 kg. ","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"27 33","pages":"1-97"},"PeriodicalIF":3.5,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017152/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139039793","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}