Health technology assessment最新文献

{"title":"Artificial intelligence software for analysing chest X-ray images to identify suspected lung cancer: an evidence synthesis early value assessment.","authors":"Jill Colquitt, Mary Jordan, Rachel Court, Emma Loveman, Janette Parr, Iman Ghosh, Peter Auguste, Mubarak Patel, Chris Stinton","doi":"10.3310/LKRT4721","DOIUrl":"https://doi.org/10.3310/LKRT4721","url":null,"abstract":"<p><strong>Background: </strong>Lung cancer is one of the most common types of cancer in the United Kingdom. It is often diagnosed late. The 5-year survival rate for lung cancer is below 10%. Early diagnosis may improve survival. Software that has an artificial intelligence-developed algorithm might be useful in assisting with the identification of suspected lung cancer.</p><p><strong>Objectives: </strong>This review sought to identify evidence on adjunct artificial intelligence software for analysing chest X-rays for suspected lung cancer, and to develop a conceptual cost-effectiveness model to inform discussion of what would be required to develop a fully executable cost-effectiveness model for future economic evaluation.</p><p><strong>Data sources: </strong>The data sources were MEDLINE All, EMBASE, Cochrane Database of Systematic Reviews, Cochrane CENTRAL, Epistemonikos, ACM Digital Library, World Health Organization International Clinical Trials Registry Platform, clinical experts, Tufts Cost-Effectiveness Analysis Registry, company submissions and clinical experts. Searches were conducted from 25 November 2022 to 18 January 2023.</p><p><strong>Methods: </strong>Rapid evidence synthesis methods were employed. Data from companies were scrutinised. The eligibility criteria were (1) primary care populations referred for chest X-ray due to symptoms suggestive of lung cancer or reasons unrelated to lung cancer; (2) study designs that compared radiology specialist assessing chest X-ray with adjunct artificial intelligence software versus radiology specialists alone and (3) outcomes relating to test accuracy, practical implications of using artificial intelligence software and patient-related outcomes. A conceptual decision-analytic model was developed to inform a potential full cost-effectiveness evaluation of adjunct artificial intelligence software for analysing chest X-ray images to identify suspected lung cancer.</p><p><strong>Results: </strong>None of the studies identified in the searches or submitted by the companies met the inclusion criteria of the review. Contextual information from six studies that did not meet the inclusion criteria provided some evidence that sensitivity for lung cancer detection (but not nodule detection) might be higher when chest X-rays are interpreted by radiology specialists in combination with artificial intelligence software than when they are interpreted by radiology specialists alone. No significant differences were observed for specificity, positive predictive value or number of cancers detected. None of the six studies provided evidence on the clinical effectiveness of adjunct artificial intelligence software. The conceptual model highlighted a paucity of input data along the course of the diagnostic pathway and identified key assumptions required for evidence linkage.</p><p><strong>Limitations: </strong>This review employed rapid evidence synthesis methods. This included only one reviewer conducting all el","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 50","pages":"1-75"},"PeriodicalIF":3.5,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11403378/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142285844","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":"Nurse-delivered sleep restriction therapy to improve insomnia disorder in primary care: the HABIT RCT.","authors":"Simon D Kyle, Peter Bower, Ly-Mee Yu, Aloysius Niroshan Siriwardena, Yaling Yang, Stavros Petrou, Emma Ogburn, Nargis Begum, Leonie Maurer, Barbara Robinson, Caroline Gardner, Stephanie Armstrong, Julie Pattinson, Colin A Espie, Paul Aveyard","doi":"10.3310/RJYT4275","DOIUrl":"10.3310/RJYT4275","url":null,"abstract":"<p><strong>Background: </strong>Insomnia is a prevalent and distressing sleep disorder. Multicomponent cognitive-behavioural therapy is the recommended first-line treatment, but access remains extremely limited, particularly in primary care where insomnia is managed. One principal component of cognitive-behavioural therapy is a behavioural treatment called sleep restriction therapy, which could potentially be delivered as a brief single-component intervention by generalists in primary care.</p><p><strong>Objectives: </strong>The primary objective of the Health-professional Administered Brief Insomnia Therapy trial was to establish whether nurse-delivered sleep restriction therapy in primary care improves insomnia relative to sleep hygiene. Secondary objectives were to establish whether nurse-delivered sleep restriction therapy was cost-effective, and to undertake a process evaluation to understand intervention delivery, fidelity and acceptability.</p><p><strong>Design: </strong>Pragmatic, multicentre, individually randomised, parallel-group, superiority trial with embedded process evaluation.</p><p><strong>Setting: </strong>National Health Service general practice in three regions of England.</p><p><strong>Participants: </strong>Adults aged ≥ 18 years with insomnia disorder were randomised using a validated web-based randomisation programme.</p><p><strong>Interventions: </strong>Participants in the intervention group were offered a brief four-session nurse-delivered behavioural treatment involving two in-person sessions and two by phone. Participants were supported to follow a prescribed sleep schedule with the aim of restricting and standardising time in bed. Participants were also provided with a sleep hygiene leaflet. The control group received the same sleep hygiene leaflet by e-mail or post. There was no restriction on usual care.</p><p><strong>Main outcome measures: </strong>Outcomes were assessed at 3, 6 and 12 months. Participants were included in the primary analysis if they contributed at least one post-randomisation outcome. The primary end point was self-reported insomnia severity with the Insomnia Severity Index at 6 months. Secondary outcomes were health-related and sleep-related quality of life, depressive symptoms, work productivity and activity impairment, self-reported and actigraphy-defined sleep, and hypnotic medication use. Cost-effectiveness was evaluated using the incremental cost per quality-adjusted life-year. For the process evaluation, semistructured interviews were carried out with participants, nurses and practice managers or general practitioners. Due to the nature of the intervention, both participants and nurses were aware of group allocation.</p><p><strong>Results: </strong>We recruited 642 participants (<i>n</i> = 321 for sleep restriction therapy; <i>n</i> = 321 for sleep hygiene) between 29 August 2018 and 23 March 2020. Five hundred and eighty participants (90.3%) provided data at a minimum of one follow-up ti","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 36","pages":"1-107"},"PeriodicalIF":3.5,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11367301/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142054174","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":"Impact of Social Stories on social and emotional health of autism spectrum primary school children: the ASSSIST2 RCT with economic evaluation.","authors":"Barry Wright, Kerry Jane Bell, Jane E Blackwell, Catarina Teige, Laura Mandefield, Han I Wang, Charlie Welch, Arabella Scantlebury, Jude Watson, Dean McMillan, Emma Standley, Leah Attwell, Hayley Carrick, Amelia Taylor, Olivia Taylor, Rachel Hodkinson, Hannah Edwards, Hannah Pearson, Steve Parrott, David Marshall, Danielle Varley, Rebecca Hargate, Ann Mclaren, Catherine Elizabeth Hewitt","doi":"10.3310/JBTM8017","DOIUrl":"10.3310/JBTM8017","url":null,"abstract":"<p><strong>Background: </strong>Differences in the way autistic children experience the world can contribute to anxiety and stress. Carol Gray's Social Stories™ are a highly personalised intervention to support children by providing social information about specific situations in an individual story.</p><p><strong>Objectives: </strong>This randomised controlled trial aimed to establish whether Social Stories are clinically effective and cost-effective in improving social responsiveness and social and emotional health in children on the autism spectrum in schools.</p><p><strong>Design: </strong>A multisite pragmatic cluster randomised controlled trial comparing Social Stories with care as usual.</p><p><strong>Setting: </strong>Eighty-seven schools (clusters) across Yorkshire and the Humber.</p><p><strong>Participants: </strong>Two hundred and forty-nine children were randomised via a bespoke system hosted at York Trials Unit (129 Social Stories and 120 care as usual). Recruitment was completed in May 2021. Participants were children aged 4-11 years with a diagnosis of autism, alongside teachers, interventionists and caregivers. Recruitment was via schools, NHS trusts, support groups and local publicity.</p><p><strong>Intervention: </strong>The intervention included training for educational professionals and caregivers covering psychoeducation and implementation of Social Stories. Stories were written around contextualised goals around the child's need for social information. Interventionists read the Social Story™ with the child at least six times over 4 weeks during school.</p><p><strong>Main outcome measure: </strong>The primary outcome was the Social Responsiveness Scale-2 completed by teachers at 6 months (the primary end point), which measures social awareness, cognition, communication and behaviour. Data were collected from caregivers and educational professionals at 6 weeks and 6 months through questionnaires. Blinding of participants was not possible.</p><p><strong>Results: </strong>At 6 months, the estimated difference in expected teacher-reported Social Responsiveness Scale-2 T-score (the primary end point) was -1.61 (95% confidence interval -4.18 to 0.96, <i>p</i> = 0.220), slightly favouring the intervention group. The estimated differences for the parent-reported secondary outcomes at 6 months were small and generally favoured the control group except the measure of children's quality-adjusted life-year (+ 0.001, 95% confidence interval -0.032 to 0.035) and parental stress (-1.49, 95% confidence interval -5.43 to 2.46, <i>p</i> = 0.460), which favoured the intervention group. Children in the intervention group met their individual goals more frequently than children who received usual care alone (0.97 confidence interval 0.21 to 1.73, <i>p</i> = 0.012). The intervention is likely to save small costs (-£191 per child, 95% confidence interval -767.7 to 337.7) and maintain a similar quality of life compared to usual care. The probability","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 39","pages":"1-121"},"PeriodicalIF":3.5,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142106913","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":"Real-time ultrasound elastography in the diagnosis of newly identified thyroid nodules in adults: the ElaTION RCT.","authors":"Hisham Mehanna, Jonathan J Deeks, Kristien Boelaert, Gitta Madani, Paul Sidhu, Paul Nankivell, Neil Sharma, Rebecca Woolley, Judith Taylor, Tessa Fulton-Lieuw, Andrew Palmer","doi":"10.3310/PLEQ4874","DOIUrl":"https://doi.org/10.3310/PLEQ4874","url":null,"abstract":"<p><strong>Background: </strong>Strain and shear wave elastography which is commonly used with concurrent real-time imaging known as real-time ultrasound shear/strain wave elastography is a new diagnostic technique that has been reported to be useful in the diagnosis of nodules in several organs. There is conflicting evidence regarding its benefit over ultrasound-guided fine-needle aspiration cytology alone in thyroid nodules.</p><p><strong>Objectives: </strong>To determine if ultrasound strain and shear wave elastography in conjunction with fine-needle aspiration cytology will reduce the number of patients who have a non-diagnostic first fine-needle aspiration cytology results as compared to conventional ultrasound-only guided fine-needle aspiration cytology.</p><p><strong>Design: </strong>A pragmatic, unblinded, multicentre randomised controlled trial.</p><p><strong>Setting: </strong>Eighteen centres with a radiology department across England.</p><p><strong>Participants: </strong>Adults who had not undergone previous fine-needle aspiration cytology with single or multiple nodules undergoing investigation.</p><p><strong>Interventions: </strong>Ultrasound shear/strain wave elastography-ultrasound guided fine-needle aspiration cytology (intervention arm) - strain or shear wave elastography-guided fine-needle aspiration cytology. Ultrasound-only guided fine-needle aspiration cytology (control arm) - routine ultrasound-only guided fine-needle aspiration cytology (the current standard recommended by the British Thyroid Association guidelines).</p><p><strong>Main outcome measure: </strong>The proportion of patients who have a non-diagnostic cytology (Thy 1) result following the first fine-needle aspiration cytology.</p><p><strong>Randomisation: </strong>Patients were randomised at a 1 : 1 ratio to the interventional or control arms.</p><p><strong>Results: </strong>A total of 982 participants (80% female) were randomised: 493 were randomised to ultrasound shear/strain wave elastography-ultrasound guided fine-needle aspiration cytology and 489 were randomised to ultrasound-only guided fine-needle aspiration cytology. There was no evidence of a difference between ultrasound shear/strain wave elastography and ultrasound in non-diagnostic cytology (Thy 1) rate following the first fine-needle aspiration cytology (19% vs. 16% respectively; risk difference: 0.030; 95% confidence interval -0.007 to 0.066; <i>p</i> = 0.11), the number of fine-needle aspiration cytologies needed (odds ratio: 1.10; 95% confidence interval 0.82 to 1.49; <i>p</i> = 0.53) or in the time to reach a definitive diagnosis (hazard ratio: 0.94; 95% confidence interval 0.81 to 1.10; <i>p</i> = 0.45). There was a small, non-significant reduction in the number of thyroid operations undertaken when ultrasound shear/strain wave elastography was used (37% vs. 40% respectively; risk difference: -0.02; 95% confidence interval -0.06 to 0.009; <i>p</i> = 0.15), but no difference in the number of op","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 46","pages":"1-51"},"PeriodicalIF":3.5,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11403383/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142285840","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":"Automated devices for identifying peripheral arterial disease in people with leg ulceration: an evidence synthesis and cost-effectiveness analysis.","authors":"Dwayne Boyers, Moira Cruickshank, Lorna Aucott, Charlotte Kennedy, Paul Manson, Paul Bachoo, Miriam Brazzelli","doi":"10.3310/TWCG3912","DOIUrl":"10.3310/TWCG3912","url":null,"abstract":"<p><strong>Background: </strong>Peripheral artery disease is a common condition caused by narrowing/blockage of the arteries, resulting in reduced blood supply. Peripheral artery disease is associated with an increased risk of vascular complications, but early treatment reduces mortality and morbidity. Leg ulcers are long-lasting wounds, usually treated by compression therapy. Compression therapy is not suitable for people with peripheral artery disease, as it can affect the arterial blood supply. In clinical practice, people with peripheral artery disease are identified by measurement of the ankle-brachial pressure index using a sphygmomanometer and manual Doppler device. However, this method can be uncomfortable for people with leg ulcers and automated devices have been proposed as a more acceptable alternative. The objective of this appraisal was to summarise the clinical and cost-effectiveness evidence on the use of automated devices to detect peripheral artery disease in people with leg ulcers.</p><p><strong>Methods: </strong>.</p><p><strong>Clinical effectiveness: </strong>To identify reports of relevant studies, we searched major electronic databases and scrutinised the information supplied by the manufacturers of the automated devices under investigation. Due to the lack of evidence on people with leg ulcers, we considered evidence from studies of any design assessing automated devices versus an acceptable reference device in any population receiving ankle-brachial pressure index assessment. We summarised information on diagnostic accuracy of the automated devices and level of agreement with the reference device. For each device, when data permit, we pooled data across studies by conducting random-effects meta-analyses using a Hierarchical Summary Receiving Operating Characteristics model.</p><p><strong>Cost-effectiveness: </strong>An economic model comprising a decision tree (24 weeks) and Markov models to capture lifetime costs and quality-adjusted life-years associated with venous, arterial and mixed aetiology disease in leg ulcer patients. Analyses were conducted from a United Kingdom National Health Service and Personal Social Services perspective. Costs and quality-adjusted life-years were discounted at 3.5% per year. Deterministic and several probabilistic analyses were used to capture uncertainty surrounding a range of optimistic and pessimistic assumptions about the impact of automated tests on health outcomes (ulcer healing and requirement for invasive management of arterial disease).</p><p><strong>Results: </strong>.</p><p><strong>Clinical effectiveness: </strong>From the 116 records retrieved by the electronic searches, we included 24 studies evaluating five devices (BlueDop Vascular Expert, BOSO ABI-System 100, Dopplex Ability, MESI ankle-brachial pressure index MD and WatchBP Office ABI). Two studies assessing people with leg ulcers found that automated devices often gave higher ankle-brachial pressure index readings than ma","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 37","pages":"1-158"},"PeriodicalIF":3.5,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11367298/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142054175","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":"Image directed redesign of bladder cancer treatment pathways: the BladderPath RCT.","authors":"Nicholas James, Sarah Pirrie, Wenyu Liu, James Catto, Kieran Jefferson, Prashant Patel, Ana Hughes, Ann Pope, Veronica Nanton, Harriet P Mintz, Allen Knight, Jean Gallagher, Richard T Bryan","doi":"10.3310/DEHT5407","DOIUrl":"10.3310/DEHT5407","url":null,"abstract":"<p><strong>Background: </strong>Transurethral resection of bladder tumour has been the mainstay of bladder cancer staging for > 60 years. Staging inaccuracies are commonplace, leading to delayed treatment of muscle-invasive bladder cancer. Multiparametric magnetic resonance imaging offers rapid, accurate and non-invasive staging of muscle-invasive bladder cancer, potentially reducing delays to radical treatment.</p><p><strong>Objectives: </strong>To assess the feasibility and efficacy of the introducing multiparametric magnetic resonance imaging ahead of transurethral resection of bladder tumour in the staging of suspected muscle-invasive bladder cancer.</p><p><strong>Design: </strong>Open-label, multistage randomised controlled study in three parts: feasibility, intermediate and final clinical stages. The COVID pandemic prevented completion of the final stage.</p><p><strong>Setting: </strong>Fifteen UK hospitals.</p><p><strong>Participants: </strong>Newly diagnosed bladder cancer patients of age ≥ 18 years.</p><p><strong>Interventions: </strong>Participants were randomised to Pathway 1 or 2 following visual assessment of the suspicion of non-muscle-invasive bladder cancer or muscle-invasive bladder cancer at the time of outpatient cystoscopy, based upon a 5-point Likert scale: Likert 1-2 tumours considered probable non-muscle-invasive bladder cancer; Likert 3-5 possible muscle-invasive bladder cancer. In Pathway 1, all participants underwent transurethral resection of bladder tumour. In Pathway 2, probable non-muscle-invasive bladder cancer participants underwent transurethral resection of bladder tumour, and possible muscle-invasive bladder cancer participants underwent initial multiparametric magnetic resonance imaging. Subsequent therapy was determined by the treating team and could include transurethral resection of bladder tumour.</p><p><strong>Main outcome measures: </strong>Feasibility stage: proportion with possible muscle-invasive bladder cancer randomised to Pathway 2 which correctly followed the protocol. Intermediate stage: time to correct treatment for muscle-invasive bladder cancer.</p><p><strong>Results: </strong>Between 31 May 2018 and 31 December 2021, of 638 patients approached, 143 participants were randomised; 52.1% were deemed as possible muscle-invasive bladder cancer and 47.9% probable non-muscle-invasive bladder cancer. Feasibility stage: 36/39 [92% (95% confidence interval 79 to 98%)] muscle-invasive bladder cancer participants followed the correct treatment by pathway. Intermediate stage: median time to correct treatment was 98 (95% confidence interval 72 to 125) days for Pathway 1 versus 53 (95% confidence interval 20 to 89) days for Pathway 2 [hazard ratio 2.9 (95% confidence interval 1.0 to 8.1)], <i>p</i> = 0.040. Median time to correct treatment for all participants was 37 days for Pathway 1 and 25 days for Pathway 2 [hazard ratio 1.4 (95% confidence interval 0.9 to 2.0)].</p><p><strong>Limitations: </strong>For pa","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 42","pages":"1-65"},"PeriodicalIF":3.5,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11403381/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142153873","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":"Community-based complex interventions to sustain independence in older people, stratified by frailty: a systematic review and network meta-analysis.","authors":"Thomas Frederick Crocker, Natalie Lam, Joie Ensor, Magda Jordão, Ram Bajpai, Matthew Bond, Anne Forster, Richard D Riley, Deirdre Andre, Caroline Brundle, Alison Ellwood, John Green, Matthew Hale, Jessica Morgan, Eleftheria Patetsini, Matthew Prescott, Ridha Ramiz, Oliver Todd, Rebecca Walford, John Gladman, Andrew Clegg","doi":"10.3310/HNRP2514","DOIUrl":"10.3310/HNRP2514","url":null,"abstract":"<p><strong>Background: </strong>Sustaining independence is important for older people, but there is insufficient guidance about which community health and care services to implement.</p><p><strong>Objectives: </strong>To synthesise evidence of the effectiveness of community services to sustain independence for older people grouped according to their intervention components, and to examine if frailty moderates the effect.</p><p><strong>Review design: </strong>Systematic review and network meta-analysis.</p><p><strong>Eligibility criteria: </strong>Studies: Randomised controlled trials or cluster-randomised controlled trials. Participants: Older people (mean age 65+) living at home. Interventions: community-based complex interventions for sustaining independence. Comparators: usual care, placebo or another complex intervention.</p><p><strong>Main outcomes: </strong>Living at home, instrumental activities of daily living, personal activities of daily living, care-home placement and service/economic outcomes at 1 year.</p><p><strong>Data sources: </strong>We searched MEDLINE (1946-), Embase (1947-), CINAHL (1972-), PsycINFO (1806-), CENTRAL and trial registries from inception to August 2021, without restrictions, and scanned reference lists.</p><p><strong>Review methods: </strong>Interventions were coded, summarised and grouped. Study populations were classified by frailty. A random-effects network meta-analysis was used. We assessed trial-result risk of bias (Cochrane RoB 2), network meta-analysis inconsistency and certainty of evidence (Grading of Recommendations Assessment, Development and Evaluation for network meta-analysis).</p><p><strong>Results: </strong>We included 129 studies (74,946 participants). Nineteen intervention components, including 'multifactorial-action' (multidomain assessment and management/individualised care planning), were identified in 63 combinations. The following results were of low certainty unless otherwise stated. For living at home, compared to no intervention/placebo, evidence favoured: multifactorial-action and review with medication-review (odds ratio 1.22, 95% confidence interval 0.93 to 1.59; moderate certainty) multifactorial-action with medication-review (odds ratio 2.55, 95% confidence interval 0.61 to 10.60) cognitive training, medication-review, nutrition and exercise (odds ratio 1.93, 95% confidence interval 0.79 to 4.77) and activities of daily living training, nutrition and exercise (odds ratio 1.79, 95% confidence interval 0.67 to 4.76). Four intervention combinations may reduce living at home. For instrumental activities of daily living, evidence favoured multifactorial-action and review with medication-review (standardised mean difference 0.11, 95% confidence interval 0.00 to 0.21; moderate certainty). Two interventions may reduce instrumental activities of daily living. For personal activities of daily living, evidence favoured exercise, multifactorial-action and review with medication-review and sel","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 48","pages":"1-194"},"PeriodicalIF":3.5,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11403382/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142285842","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 validation of prediction models for fetal growth restriction and birthweight: an individual participant data meta-analysis.","authors":"John Allotey, Lucinda Archer, Dyuti Coomar, Kym Ie Snell, Melanie Smuk, Lucy Oakey, Sadia Haqnawaz, Ana Pilar Betrán, Lucy C Chappell, Wessel Ganzevoort, Sanne Gordijn, Asma Khalil, Ben W Mol, Rachel K Morris, Jenny Myers, Aris T Papageorghiou, Basky Thilaganathan, Fabricio Da Silva Costa, Fabio Facchinetti, Arri Coomarasamy, Akihide Ohkuchi, Anne Eskild, Javier Arenas Ramírez, Alberto Galindo, Ignacio Herraiz, Federico Prefumo, Shigeru Saito, Line Sletner, Jose Guilherme Cecatti, Rinat Gabbay-Benziv, Francois Goffinet, Ahmet A Baschat, Renato T Souza, Fionnuala Mone, Diane Farrar, Seppo Heinonen, Kjell Å Salvesen, Luc Jm Smits, Sohinee Bhattacharya, Chie Nagata, Satoru Takeda, Marleen Mhj van Gelder, Dewi Anggraini, SeonAe Yeo, Jane West, Javier Zamora, Hema Mistry, Richard D Riley, Shakila Thangaratinam","doi":"10.3310/DABW4814","DOIUrl":"10.3310/DABW4814","url":null,"abstract":"<p><strong>Background: </strong>Fetal growth restriction is associated with perinatal morbidity and mortality. Early identification of women having at-risk fetuses can reduce perinatal adverse outcomes.</p><p><strong>Objectives: </strong>To assess the predictive performance of existing models predicting fetal growth restriction and birthweight, and if needed, to develop and validate new multivariable models using individual participant data.</p><p><strong>Design: </strong>Individual participant data meta-analyses of cohorts in International Prediction of Pregnancy Complications network, decision curve analysis and health economics analysis.</p><p><strong>Participants: </strong>Pregnant women at booking. External validation of existing models (9 cohorts, 441,415 pregnancies); International Prediction of Pregnancy Complications model development and validation (4 cohorts, 237,228 pregnancies).</p><p><strong>Predictors: </strong>Maternal clinical characteristics, biochemical and ultrasound markers.</p><p><strong>Primary outcomes: </strong>fetal growth restriction defined as birthweight <10th centile adjusted for gestational age and with stillbirth, neonatal death or delivery before 32 weeks' gestation birthweight.</p><p><strong>Analysis: </strong>First, we externally validated existing models using individual participant data meta-analysis. If needed, we developed and validated new International Prediction of Pregnancy Complications models using random-intercept regression models with backward elimination for variable selection and undertook internal-external cross-validation. We estimated the study-specific performance (<i>c</i>-statistic, calibration slope, calibration-in-the-large) for each model and pooled using random-effects meta-analysis. Heterogeneity was quantified using τ<sup>2</sup> and 95% prediction intervals. We assessed the clinical utility of the fetal growth restriction model using decision curve analysis, and health economics analysis based on National Institute for Health and Care Excellence 2008 model.</p><p><strong>Results: </strong>Of the 119 published models, one birthweight model (Poon) could be validated. None reported fetal growth restriction using our definition. Across all cohorts, the Poon model had good summary calibration slope of 0.93 (95% confidence interval 0.90 to 0.96) with slight overfitting, and underpredicted birthweight by 90.4 g on average (95% confidence interval 37.9 g to 142.9 g). The newly developed International Prediction of Pregnancy Complications-fetal growth restriction model included maternal age, height, parity, smoking status, ethnicity, and any history of hypertension, pre-eclampsia, previous stillbirth or small for gestational age baby and gestational age at delivery. This allowed predictions conditional on a range of assumed gestational ages at delivery. The pooled apparent <i>c</i>-statistic and calibration were 0.96 (95% confidence interval 0.51 to 1.0), and 0.95 (95% confidence interval 0.67","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 47","pages":"1-119"},"PeriodicalIF":3.5,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11404361/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142285841","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":"Lenvatinib plus pembrolizumab for untreated advanced renal cell carcinoma: a systematic review and cost-effectiveness analysis.","authors":"Nigel Fleeman, Rachel Houten, Sarah Nevitt, James Mahon, Sophie Beale, Angela Boland, Janette Greenhalgh, Katherine Edwards, Michelle Maden, Devarshi Bhattacharyya, Marty Chaplin, Joanne McEntee, Shien Chow, Tom Waddell","doi":"10.3310/TRRM4238","DOIUrl":"10.3310/TRRM4238","url":null,"abstract":"<p><strong>Background: </strong>Renal cell carcinoma is the most common type of kidney cancer, comprising approximately 85% of all renal malignancies. Patients with advanced renal cell carcinoma are the focus of this National Institute for Health and Care Excellence multiple technology appraisal. A patient's risk of disease progression depends on a number of prognostic risk factors; patients are categorised as having intermediate/poor risk or favourable risk of disease progression.</p><p><strong>Objectives: </strong>The objectives of this multiple technology appraisal were to appraise the clinical effectiveness and cost-effectiveness of lenvatinib plus pembrolizumab versus relevant comparators listed in the final scope issued by the National Institute for Health and Care Excellence: sunitinib, pazopanib, tivozanib, cabozantinib and nivolumab plus ipilimumab.</p><p><strong>Methods: </strong>The assessment group carried out clinical and economic systematic reviews and assessed the clinical and cost-effectiveness evidence submitted by Eisai, Hatfield, Hertfordshire, UK (the manufacturer of lenvatinib) and Merck Sharp & Dohme, Whitehouse Station, NJ, USA (the manufacturer of pembrolizumab). The assessment group carried out fixed-effects network meta-analyses using a Bayesian framework to generate evidence for clinical effectiveness. As convergence issues occurred due to sparse data, random-effects network meta-analysis results were unusable. The assessment group did not develop a de novo economic model, but instead modified the partitioned survival model provided by Merck Sharp & Dohme.</p><p><strong>Results: </strong>The assessment group clinical systematic review identified one relevant randomised controlled trial (CLEAR trial). The CLEAR trial is a good-quality, phase III, multicentre, open-label trial that provided evidence for the efficacy and safety of lenvatinib plus pembrolizumab compared with sunitinib. The assessment group progression-free survival network meta-analysis results for all three risk groups should not be used to infer any statistically significant difference (or lack of statistically significant difference) for any of the treatment comparisons owing to within-trial proportional hazards violations or uncertainty regarding the validity of the proportional hazards assumption. The assessment group overall survival network meta-analysis results for the intermediate-/poor-risk subgroup suggested that there was a numerical, but not statistically significant, improvement in the overall survival for patients treated with lenvatinib plus pembrolizumab compared with patients treated with cabozantinib or nivolumab plus ipilimumab. Because of within-trial proportional hazards violations or uncertainty regarding the validity of the proportional hazards assumption, the assessment group overall survival network meta-analysis results for the favourable-risk subgroup and the all-risk population should not be used to infer any statistically signi","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 49","pages":"1-190"},"PeriodicalIF":3.5,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11404358/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142285843","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":"Reducing self-harm in adolescents: the RISA-IPD individual patient data meta-analysis and systematic review.","authors":"David Cottrell, Alex Wright-Hughes, Amanda Farrin, Rebecca Walwyn, Faraz Mughal, Alex Truscott, Emma Diggins, Donna Irving, Peter Fonagy, Dennis Ougrin, Daniel Stahl, Judy Wright","doi":"10.3310/GTNT6331","DOIUrl":"https://doi.org/10.3310/GTNT6331","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Method: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</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 17/117/11. A plain language summary of this research article is available on the NIHR Journals Library Website https://doi.org/10.3310/GTNT6331.</p>","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"1-42"},"PeriodicalIF":3.5,"publicationDate":"2024-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141723589","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}