Health technology assessment最新文献

{"title":"Gabapentin as an adjunct to multimodal pain regimens in surgical patients: the GAP placebo-controlled RCT and economic evaluation.","authors":"Sarah Baos, Terrie Walker-Smith, Mandy Lui, Elizabeth A Stokes, Jingjing Jiang, Maria Pufulete, Ben Gibbison, Chris A Rogers","doi":"10.3310/PLMH9787","DOIUrl":"10.3310/PLMH9787","url":null,"abstract":"<p><strong>Background: </strong>Gabapentin is an anticonvulsant medication with a United Kingdom licence to treat partial seizures and neuropathic pain. It is used off-licence for acute pain and is frequently added to multimodal analgesic regimens after surgery to try and reduce opioid use while controlling pain effectively.</p><p><strong>Objective: </strong>To test the hypothesis that gabapentin reduces opioid use after major surgery and speeds up recovery, thereby reducing postoperative hospital length of stay compared to standard multimodal analgesia.</p><p><strong>Design, setting and participants: </strong>The GAP study was a multicentre, blinded, randomised controlled trial in patients aged ≥ 18 years, undergoing cardiac, thoracic or abdominal surgery with an expected postoperative stay of ≥ 2 days in seven National Health Service hospitals. The trial was designed to provide 90% power to detect a difference of 12.5% in the proportion of participants discharged by the median length of stay in <i>each</i> specialty (500 participants/specialty), which was reduced to 80% (340 participants/specialty) due to COVID-19-related recruitment challenges.</p><p><strong>Interventions: </strong>Participants were randomised 1 : 1 (stratified by surgical specialty) to receive either gabapentin (600 mg before surgery, 300 mg twice daily for 2 days after surgery) or placebo as an adjunct to multimodal pain regimens.</p><p><strong>Main outcome measures: </strong>Primary outcome was length of stay. Secondary outcomes included acute and chronic (Brief Pain Inventory) pain, total opioid use, adverse health events, health-related quality of life (-EQ-5D-5L, Short Form questionnaire-12 items physical component score and mental component score), resource use; cost-effectiveness (outcome measure quality-adjusted life-years using EQ-5D, five-level version).</p><p><strong>Results: </strong>One thousand one hundred and ninety-six (cardiac 500, thoracic 346, abdominal 350) participants consented and were randomised. Baseline characteristics were well balanced across the two groups: median age: 68 years; male sex 796/1195 (66.4%). Of the participants, 223/1195 (18.7%) did not receive all prescribed medication or received medication out of window. There was no difference in length of stay; median placebo (<i>n</i> = 589): 6.15, gabapentin (<i>n</i> = 595): 5.94 days [hazard ratio for discharge 1.07, 95% confidence interval (0.95 to 1.20), <i>p</i> = 0.26]. Opioid use <i>in-hospital</i> differed between surgical specialties (<i>p</i> = 0.001); in the abdominal specialty, it was significantly lower in the gabapentin group in 4 of the first 5 postoperative days [range -26% (-46% to 0%) to -36% (-52% to -14%)], with no differences in the cardiac specialty nor in the thoracic specialty beyond day 2. <i>During follow-up</i>, opioid use was similar in the two groups across all specialties. Acute pain beyond 24 hours was similar (<i>p</i> ≥ 0.15). The incidence of one or more serio","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"30 9","pages":"1-144"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12907993/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146142399","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":"Views on outpatient paracentesis and GnRH antagonists for ovarian hyperstimulation syndrome: a qualitative study of patients and healthcare professionals.","authors":"Elizabeth Lumley, Alicia O'Cathain, Katie Ridsdale, Sarah Drabble, David White, Clare Pye, Jessica Wright, Andrew Drakeley, Ying Cheong, Raj Mathur, Amy Barr, Mostafa Metwally","doi":"10.3310/GJMM2923","DOIUrl":"10.3310/GJMM2923","url":null,"abstract":"<p><strong>Background: </strong>Ovarian hyperstimulation syndrome is a significant complication of fertility treatment, where the ovaries become enlarged if they are overstimulated, resulting in fluid leakage. Ovarian hyperstimulation syndrome can be classified as mild, moderate or severe. Symptoms vary dependent on severity but can include abdominal swelling, pain, nausea and vomiting, and shortness of breath. Treatment typically consists of monitoring initially, with active intervention if the condition progresses to a severe state, requiring hospitalisation. This study explored the acceptability and feasibility of outpatient paracentesis, and of gonadotropin-releasing hormone antagonists, as early interventions for ovarian hyperstimulation syndrome.</p><p><strong>Methods: </strong>We conducted qualitative semi-structured interviews with healthcare professionals from fertility clinics (<i>n</i> = 8) and patients who had experienced ovarian hyperstimulation syndrome (<i>n</i> = 10) across six United Kingdom fertility clinics. Interviews explored views on the proposed treatment protocols, and potential barriers and facilitators to randomised controlled trials evaluating these treatments.</p><p><strong>Results: </strong>Both healthcare professionals and patients were supportive of the proposed trials. Key findings included that healthcare professionals recommended clarity on patient eligibility, hospitalisation criteria and consent procedures. Patients expressed a desire to be given more detailed information about potential trials and had mixed opinions on self-monitoring. There were some concerns from both parties about treatment risks, particularly the paracentesis. Healthcare professionals noted a shift to more preventative practice due to the COVID-19 pandemic.</p><p><strong>Conclusions: </strong>Outpatient paracentesis and gonadotropin-releasing hormone antagonists were perceived as promising interventions. Potential concerns and recommendations around both acceptability and feasibility were raised, which were used to refine the treatment protocols for the Shaping and Trialling Outpatient Protocols for Ovarian Hyperstimulation Syndrome trial.</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 NIHR128137.</p>","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"1-14"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12968949/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147343987","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":"Feasibility, acceptability and appropriateness of laparoscopic versus abdominal hysterectomy for women and healthcare professionals: the LAVA trial qualitative process evaluation.","authors":"Lynsay Matthews, T Justin Clark, Sheriden Bevan, Lee Middleton, Lina Antoun, Paul Smith, Ertan Saridogan, Rebecca Woolley, Monique Morgan, Laura L Jones","doi":"10.3310/GJTC1325","DOIUrl":"10.3310/GJTC1325","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Laparoscopic hysterectomies performed for benign gynaecological conditions are increasing. However, there is a lack of up-to-date evidence on their surgical outcomes when compared with abdominal hysterectomy. The LAparoscopic Versus Abdominal hysterectomy trial aimed to address this gap. A qualitative process evaluation was embedded within the pilot phase of the LAparoscopic Versus Abdominal hysterectomy trial.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To explore the feasibility, acceptability and appropriateness of LAparoscopic Versus Abdominal hysterectomy for women and healthcare professionals.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design and methods: &lt;/strong&gt;A qualitative process evaluation using semistructured interviews informed by the Medical Research Council/National Institute for Health and Care Research updated Framework for Developing and Evaluating Complex Interventions. Interviews were thematically analysed to inform the development of a LAparoscopic Versus Abdominal hysterectomy trial programme theory (used to demonstrate how an intervention is expected to lead to its effects, under what conditions and for which stakeholders).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Setting and participants: &lt;/strong&gt;Eligible women and healthcare professionals (gynaecologists, research nurses and research midwives) from participating clinical sites in National Health Service England.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcome measures: &lt;/strong&gt;Insight on the feasibility,acceptability and appropriateness of LAparoscopic Versus Abdominal hysterectomy related to the: (1) environment, (2) patient and (3) the healthcare professionals.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Eleven women and 7 healthcare professionals (6 research nurses and 1 consultant gynaecologist) were interviewed. Four themes were interpreted. Theme 1 identified &lt;b&gt;decision-making processes&lt;/b&gt; for LAparoscopic Versus Abdominal hysterectomy participation. &lt;i&gt;Conditional altruism&lt;/i&gt; motivated women to participate, alongside the 'relief' of being offered a hysterectomy. The decision to decline participation was influenced by surgical preference and beliefs of laparoscopy having a faster recovery rate. Theme 2 highlighted &lt;b&gt;surgical preferences&lt;/b&gt;, with women's preferences being influenced by their previous experiences of surgery or perceived recovery times and family/friends. All healthcare professionals demonstrated &lt;i&gt;community equipoise&lt;/i&gt; but did observe that 'younger surgeons' may prefer laparoscopic surgery based on their contemporary training. Theme 3 identified &lt;b&gt;attitudes towards the LAparoscopic Versus Abdominal hysterectomy trial&lt;/b&gt;, with women and healthcare professionals reporting positively about LAparoscopic Versus Abdominal hysterectomy's feasibility, acceptability and appropriateness in terms of burden, information and understanding of the study. Theme 4 identified the &lt;b&gt;facilitators and barriers&lt;/b&gt; for LAparoscopic Versus Abdominal hysterectomy participation. Facilitators included the key role of the resear","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"29-50"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12376202/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144729898","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":"Establishing the safety of waterbirth for mothers and their babies: the POOL cohort study with nested qualitative component.","authors":"Julia Sanders, Christian Barlow, Peter Brocklehurst, Rebecca Cannings-John, Susan Channon, Christopher Gale, Judith Cutter, Jacqueline Hughes, Billie Hunter, Fiona Lugg-Widger, Sarah Milosevic, Rebecca Milton, Leah Morantz, Mary Nolan, Rachel Plachcinski, Shantini Paranjothy, Michael Robling","doi":"10.3310/GGHD6684","DOIUrl":"10.3310/GGHD6684","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Intrapartum water immersion analgesia has been recommended by the National Institute for Health and Care Excellence since 2007, but high-quality evidence relating to the safety of waterbirth for mothers and their babies was lacking.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Primary study objective: &lt;/strong&gt;To establish whether, in the case of 'low-risk' women who use water immersion during labour, waterbirth, compared to birth out of water, is as safe for mothers and their babies.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A cohort study with non-inferiority design.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Setting: &lt;/strong&gt;Twenty-six National Health Service organisations in England and Wales.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Participants: &lt;/strong&gt;The primary analysis included 60,402 births between January 2015 and June 2022. Primary analysis was restricted to births where the woman: (1) was without complicating medical conditions at the time of pool entry, (2) used water immersion during labour and (3) did not receive obstetric or anaesthetic interventions prior to birth. Comparisons were undertaken between women who gave birth in water and women who gave birth out of water.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcome measures: &lt;/strong&gt;Maternal primary outcome: obstetric anal sphincter injury (with planned subgroup analysis by parity); neonatal composite primary outcome: fetal or neonatal death (after the commencement of intrapartum care and prior to discharge home), neonatal unit admission with respiratory support or the administration of intravenous antibiotics within 48 hours of birth. Separate a priori sample size calculations were undertaken for the maternal and neonatal primary outcomes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;After adjusting for differences in the characteristics of women who used intrapartum water immersion and gave birth in or out of water: (1) among nulliparous women, rates of recorded obstetric anal sphincter injury were no higher among women who gave birth in water than among women who left the pool before birth [730 of 15,176 women (4.8%) vs. 641 of 12,210 women (5.3%); adjusted odds ratio 0.97; one-sided 95% confidence interval, -∞ to 1.08]; (2) among parous women, rates of recorded obstetric anal sphincter injury were no higher among women who gave birth in water than among women who left the pool before birth [269 of 24,451 women (1.1%) vs. 144 of 8565 women (1.7%); adjusted odds ratio 0.64; -∞ to 0.78]. Among babies, rates of the primary outcome were no higher among babies born in water than among babies born out of water [263 of 9868 infants (2.7%) vs. 224 of 5078 infants (4.4%); adjusted odds ratio, 0.65; -∞ to 0.79]. All upper confidence intervals of the primary outcomes were lower than the prespecified margins of non-inferiority; therefore, we conclude that the rate of the primary outcomes for mothers and their babies were no higher among waterbirths than among births out of water. Rates of the individual components of the neonatal primary outcome were: Intrapartum or neonatal deat","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"30 15","pages":"1-128"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12907988/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146142423","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 clinical and cost-effectiveness of paravertebral blockade versus thoracic epidural blockade in reducing chronic post-thoracotomy pain: TOPIC2 RCT synopsis.","authors":"Ben Shelley, Lee Middleton, Andreas Goebel, Stephen Grant, Louise Jackson, Mishal Javed, Marcus Jepson, Nandor Marczin, Rajnikant Mehta, Teresa Melody, Babu Naidu, Hannah Summers, Lajos Szentgyorgyi, Sarah Tearne, Ben Watkins, Matthew Wilson, Andrew Worrall, Joyce Yeung, Fang Gao Smith","doi":"10.3310/GJFG1715","DOIUrl":"10.3310/GJFG1715","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;More than a third of patients undergoing thoracotomy suffer from debilitating chronic post-thoracotomy pain lasting months or years postoperatively. Aggressive management of acute pain during the perioperative period may mitigate this risk.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective(s): &lt;/strong&gt;To determine the clinical and cost-effectiveness of paravertebral blockade compared to thoracic epidural blockade, by testing the hypothesis that paravertebral blockade reduces the incidence of chronic post-thoracotomy pain.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design and methods: &lt;/strong&gt;A parallel, open, multicentre, randomised controlled with integrated health-economic evaluation and an internal pilot that incorporated a qualitative recruitment intervention.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Setting and participants: &lt;/strong&gt;Adult patients undergoing thoracotomy in 15 United Kingdom centres.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interventions: &lt;/strong&gt;Paravertebral blockade compared to thoracic epidural blockade.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcome measures: &lt;/strong&gt;The primary outcome was the presence of chronic post-thoracotomy pain at 6 months post randomisation defined as 'worst chest pain over the last week' of at least moderate intensity, with a visual analogue scale score ≥ 40 mm. Secondary outcomes included visual analogue scale pain scores in the acute (days 1, 2, 3 and discharge) and chronic (3, 6 and 12 months) phases postoperatively; Brief Pain Inventory; Short Form McGill Pain Questionnaire 2; Hospital Anxiety and Depression Scale; patient satisfaction; analgesia use in the acute and chronic phases; complications (analgesic, surgical and pulmonary) and mortality. For the economic evaluation, the EuroQol-5 Dimensions, five-level version questionnaire was utilised.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Between 8 January 2019 and 29 September 2023, 770 patients underwent randomisation; 33 did not proceed to thoracotomy. At 6 months, 59 (22%) of 272 participants in the paravertebral blockade group and 47 (16%) of 292 in the thoracic epidural blockade group developed chronic pain [adjusted risk ratio = 1.32 (95% confidence interval 0.93 to 1.86); adjusted risk difference = 0.05 (95% confidence interval -0.01 to 0.11); &lt;i&gt;p&lt;/i&gt; = 0.12]. During the acute phase, both worst and average pain was higher on day 1 with paravertebral blockade [adjusted mean difference 7.7 mm (95% confidence interval 2.8 to 12.5) and 7.0 mm (95% confidence interval 2.7 to 11.2), respectively] but not different on days 2 and 3. Hypotension was less common in the paravertebral blockade group [adjusted risk ratio = 0.66 (95% confidence interval 0.46 to 0.94)], and overall complications were comparable between groups. The health-economic analysis demonstrated that thoracic epidural blockade produced an additional 0.04 quality-adjusted life-years when compared to paravertebral blockade, and was associated with slightly lower costs, but these differences were not statistically significant.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Limitations: &lt;/strong&gt;The main limita","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"30 16","pages":"1-21"},"PeriodicalIF":3.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12907990/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146149640","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":"Treatments for renal cell carcinoma: NICE Pilot Treatment Pathways Appraisal.","authors":"Dawn Lee, Madhusubramanian Muthukumar, Alan Lovell, Caroline Farmer, Darren Burns, Justin Matthews, Helen Coelho, Brian O'Toole, Laura A Trigg, Tristan M Snowsill, Maxwell S Barnish, Thalia Nikoglou, Amanda Brand, Zain Ahmad, Ahmed Abdelsabour, Louise Crathorne, Sophie Robinson, Edward Cf Wilson, G J Melendez-Torres","doi":"10.3310/GJDL0327","DOIUrl":"10.3310/GJDL0327","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The National Institute for Health and Care Excellence is piloting a new approach to evaluating health technologies, which takes into consideration the full treatment pathway for a condition. This report describes the first pilot topic for the pathways process, which evaluated systemic treatments for advanced renal cell carcinoma.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;This pilot aimed to develop a decision model representing the treatment pathway that will be used to evaluate new technologies for advanced renal cell carcinoma. The pilot also evaluated a new treatment for renal cell carcinoma: cabozantinib (Cabometyx®; Ipsen, Slough, UK) plus nivolumab (Opdivo®; Bristol Myers Squibb, Princeton, NJ, USA).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Review methods: &lt;/strong&gt;A systematic literature review was conducted to identify evidence to inform effectiveness, safety and economic model development, including systematic literature reviews, randomised controlled trials, economic evaluations, utility studies and cost and resource use data. Real-world evidence was sought following the recommendations of the National Institute for Health and Care Excellence real-world evidence framework. Structured expert elicitation informed assumptions about overall survival and progression-free survival. Network meta-analyses were conducted to evaluate the clinical effectiveness of treatments. A de novo state transition model that was constructed with a partitioned survival analysis structure was also presented. The cost perspective of the model was that of the National Health Service and Personal Social Services; the time horizon was 40 years, costs and outcomes were discounted at 3.5% per annum and a 2022 price year was used. The model allowed sequences of up to four active lines of treatment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Information sources: &lt;/strong&gt;The review included 118 systematic literature reviews, 30 randomised controlled trials, 122 economic evaluations, 82 studies reporting utility data and 13 studies reporting cost and/or resource use data. A total of 21 real-world evidence sources were identified. Unpublished data were provided by the manufacturer and other stakeholders (competitor companies, patient and clinical organisations). The expert elicitation recruited nine United Kingdom-based oncologists.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Cabozantinib plus nivolumab was associated with better progression-free survival and overall survival than existing tyrosine kinase inhibitors as first-line treatment in the all-risk group. Using the list price of the evaluated interventions, the incremental cost-effectiveness ratio for cabozantinib plus nivolumab compared to the next non-dominated tyrosine kinase inhibitor monotherapy (pazopanib [Votrient®; Novartis, Slough, UK]) was £275,106 per quality-adjusted life-year in the all-risk population and was £379,222 in the favourable-risk population. Incremental cost-effectiveness ratios were relatively consistent across the base-case and s","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"30 1","pages":"1-221"},"PeriodicalIF":3.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12833715/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146003346","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":"Process evaluation exploring implementation and delivery of a home-based extended exercise intervention for older people with frailty: the HERO trial.","authors":"Abi J Hall, Friederike Ziegler, Matthew Prescott, Victoria A Goodwin, Claire Hulme, Amanda J Farrin, Ellen Thompson, Anne Forster, Andrew Clegg, David Clarke","doi":"10.3310/GJAC2501","DOIUrl":"10.3310/GJAC2501","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Frailty is an especially significant consequence of ageing with resulting physical decline. Some studies suggest that exercise can reduce the deleterious effects of ageing and have a positive impact on functional ability and quality of life. Further research was required to determine the clinical effectiveness and cost-effectiveness of extended community-based rehabilitation for older people following acute illness or injury. The Home-based Extended Rehabilitation for Older people trial included an embedded process evaluation and compared provision of a home-based graded exercise programme plus usual care (the Home-based Older People's Exercise intervention) versus usual care alone for community-dwelling older people with frailty.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Qualitative mixed-methods process evaluation incorporating non-participant observations, semistructured interviews and analysis of therapy records and participants' exercise diaries. Primary aims of the process evaluation were to explore fidelity and acceptability in intervention delivery. Data analysis was based on thematic analysis and was underpinned by Normalisation Process Theory.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Data were generated in 10 community services in England. Non-participant observations of 10 staff training sessions, 61 intervention delivery sessions and 8 staff trial update sessions were completed. Semistructured interviews were conducted with 10 therapy service managers, 19 therapists and 4 therapy assistants. Thirty-five interviews were conducted with intervention participants, with some including supporting carers, and 19 with usual care only participants. There was evidence of fidelity to the intervention protocol, with no significant variation between sites. Less experienced therapists were sometimes less confident in making judgements about what exercises could be adapted and tailored to the individual while maintaining intervention fidelity. Most therapists utilised planned behaviour change techniques to engage participants and sustain their involvement in the exercise programme. Intervention acceptability was generally good, with therapy staff and participants noting potential and actual benefits of the intervention and associated physical improvements for participants completing the 24-week intervention. Usual care only participant interviews provided no evidence of engagement with or perceived benefit from community-based programmes provided by the National Health Service or private providers which were equivalent to the Home-based Older People's Exercise intervention. Therapists and therapy service managers noted the value of the Home-based Older People's Exercise intervention as an addition to existing programmes that were designed to reduce the likelihood of older people with frailty requiring hospital admission. However, they felt that embedding the intervention in routine service provision would prove to be challenging within ","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"41-66"},"PeriodicalIF":3.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12720193/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145742496","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":"Addition of early vocational advice to usual primary care on sickness absence in employed adults: exploratory findings from the discontinued WAVE Randomised Controlled Trial.","authors":"Gwenllian Wynne-Jones, Martyn Lewis, Gail Sowden, Ira Madan, Karen Walker-Bone, Carolyn A Chew-Graham, Kieran Bromley, Sue Jowett, Vaughan Parsons, Gemma Mansell, Kendra Cooke, Benjamin Saunders, Rosie Harrison, Sarah A Lawton, Simon Wathall, John Pemberton, Julia Hammond, Cyrus Cooper, And Nadine E Foster","doi":"10.3310/SVEG8456","DOIUrl":"10.3310/SVEG8456","url":null,"abstract":"<p><strong>Background and objectives: </strong>To describe exploratory findings and lessons learned from the discontinued WAVE trial, which sought to determine the effectiveness and costs of adding an early vocational advice intervention to usual primary care on number of days of sickness absence over 6 months.</p><p><strong>Methods: </strong>Pragmatic, multicentre, two-parallel arm, superiority, randomised controlled trial with health economic analysis in 10 general practices in England, with nested qualitative interviews. Population: Adults with fit notes for any health condition, absent from work ≥ 2 weeks and ≤ 6 months were invited to participate. Intervention and comparator: Participants were randomised (1 : 1) to usual primary care with/without vocational advice delivered by trained Vocational Support Workers. The planned sample size was 720, the first 4 months of recruitment served as an internal pilot phase and the primary outcome was self-reported days of work absence over 6 months.</p><p><strong>Results: </strong>One hundred and thirty participants were recruited from 7955 invitations (May 2022-May 2023) before trial closure (64 usual care, 66 usual care plus vocational advice). Exploratory analysis of 125 participants (with outcome data) indicated small additional benefits of the vocational advice intervention over usual care [mean days absence = 37.86 (standard deviation = 48.76) vs. usual care = 42.66 (standard deviation = 57.67), incidence rate ratio = 0.913, 80% confidence interval (0.653 to 1.276)]. The vocational advice intervention was delivered remotely [mean = 4.8 contacts (range 1-12)]. Partial health economic evaluation found lower work productivity losses at 6 months after vocational advice intervention (£5513.84, standard deviation = £7101.43) compared to usual care (£6146.21, standard deviation = £8431.88).</p><p><strong>Conclusions, limitations and future work: </strong>Exploratory analysis indicated a signal of effect, with differences in the number of days absent from work, costs and secondary outcomes. Key lessons learned included the need for closer working with primary care teams and more flexible recruitment methods. A future fully powered randomised controlled trial of vocational advice intervention added to usual primary care is needed to determine the effectiveness and cost-effectiveness.</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 17/94/49.</p>","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"37-68"},"PeriodicalIF":3.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12884355/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146100155","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":"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.</p>","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"53-94"},"PeriodicalIF":3.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12833717/pdf/","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":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Home-based extended rehabilitation for older people with frailty (HERO): a multicentre randomised controlled trial with health economic analysis and process evaluation.","authors":"Matthew Prescott, Michelle Collinson, Abi J Hall, Rebecca Bestwick, Victoria A Goodwin, Ellen Thompson, Chris Bojke, David Clarke, Florence Day, Anne Forster, Claire Hulme, Julie Peacock, Friederike Ziegler, Amanda J Farrin, Andrew Clegg","doi":"10.3310/GJAC1602","DOIUrl":"10.3310/GJAC1602","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Half of older people in hospital have frailty and are at increased risk of re-admission or death following discharge. Although short-term rehabilitation can reduce early re-admissions, benefits are attenuated over time. It is unknown whether extended rehabilitation for older people with frailty can improve outcomes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial design: &lt;/strong&gt;Pragmatic, multicentre, individually randomised controlled parallel-group superiority trial with economic evaluation and embedded process evaluation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Participants: Eligible participants were 65 years or older with mild/moderate/severe frailty (score of 5-7 on Clinical Frailty Scale) admitted to hospital with acute illness or injury, then discharged home directly or from intermediate care (post-acute care) rehabilitation services. People with significant cognitive impairment and care home residents were among those ineligible. Recruitment took place from December 2017 to August 2021, with follow-up till August 2022. Interventions: Participants were randomly assigned (1.28 : 1) to the Home-based Older People's Exercise programme - a 24-week home-based manualised, progressive exercise intervention delivered by National Health Service therapists as extended rehabilitation, or usual care (control). Randomisation occurred after the participant had been discharged from hospital or intermediate care. Participants were not masked to allocation. Main outcome measures: The primary outcome was physical health-related quality of life, measured using the physical component score of the modified Short Form 36-item health questionnaire at 12 months. Secondary outcomes at 6 and 12 months included physical and mental health-related quality of life, functional independence, death, hospitalisations and care home admissions. Researchers involved in data collection were masked to allocation. Data sources: Primary and secondary outcomes were obtained via self-report questionnaire at 6 and 12 months. Hospitalisations and deaths were collected from routine healthcare data.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;We randomised 740 participants (410 Home-based Older People's Exercise, 330 control) across 15 sites. Four hundred and seventy-nine (64.7%) participants completed 12-month follow-up. One hundred and eighty-eight Home-based Older People's Exercise participants (45.9%) completed 24 weeks of intervention delivery. Over half of participants completed more than 75% of prescribed exercises. Intention-to-treat analyses (258 Home-based Older People's Exercise participants, 208 control participants for primary outcome) showed no evidence that Home-based Older People's Exercise was superior to control for 12-month physical component score (adjusted mean difference -0.22, 95% confidence interval -1.47 to 1.03; &lt;i&gt;p&lt;/i&gt; = 0.73). There was some evidence of a higher rate of all-cause hospitalisations in the control arm (incidence rate ratio 1.12, 95% confidence interval 1.0","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"30 4","pages":"1-40"},"PeriodicalIF":3.4,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12833716/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146010043","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}