Health technology assessment最新文献

{"title":"Care models for coexisting serious mental health and alcohol/drug conditions: the RECO realist evidence synthesis and case study evaluation.","authors":"Elizabeth Hughes, Jane Harris, Tom Ainscough, Angela Bate, Alex Copello, Sonia Dalkin, Gail Gilchrist, Emma Griffith, Lisa Jones, Michelle Maden, Luke Mitcheson, Harry Sumnall, Charlotte Walker","doi":"10.3310/JTNT0476","DOIUrl":"10.3310/JTNT0476","url":null,"abstract":"<p><strong>Background: </strong>People with severe mental illness who experience co-occurring substance use experience poor outcome including suicide, violence, relapses and use of crisis services. They struggle to access care and treatment due to a lack of an integrated and co-ordinated approach which means that some people can fall between services. Despite these concerns, there is limited evidence as to what works for this population.</p><p><strong>Objectives: </strong>To undertake a realist evaluation of service models in order to identify and refine programme theories of what works under what contexts for this population.</p><p><strong>Design: </strong>Realist synthesis and evaluation using published literature and case study data.</p><p><strong>Setting: </strong>Mental health, substance use and related services that had some form of service provision in six locations in the United Kingdom (five in England and one in Northern Ireland).</p><p><strong>Participants: </strong>People with lived experience of severe mental illness and co-occurring substance use, carers and staff who work in the specialist roles as well as staff in mental health and substance use services.</p><p><strong>Results: </strong>Eleven initial programme theories were generated by the evidence synthesis and in conjunction with stakeholders. These theories were refined through focus groups and interviews with 58 staff, 25 service users and 12 carers across the 6 case study areas. We identified three forms of service provision (network, consultancy and lead and link worker); however, all offered broadly similar interventions. Evidence was identified to support most of the 11 programme theories. Theories clustered around effective leadership, workforce development and collaborative integrated care pathways. Outcomes that are meaningful for service users and staff were identified, including the importance of engagement.</p><p><strong>Limitations: </strong>The requirement for online data collection (due to the COVID-19 pandemic) worked well for staff data but worked less well for service users and carers. Consequently, this may have reduced the involvement of those without access to information technology equipment.</p><p><strong>Conclusion: </strong>The realist evaluation co-occurring study provides details on how and in what circumstances integrated care can work better for people with co-occurring severe mental health and alcohol/drug conditions. This requires joined-up policy at government level and local integration of services. We have also identified the value of expert clinicians who can support the workforce in sustaining this programme of work. People with co-occurring severe mental health and alcohol/drug conditions have complex and multifaceted needs which require a comprehensive and long-term integrated approach. The shift to integrated health and social care is promising but will require local support (local expert leaders, network opportunities and clarity of role","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 67","pages":"1-100"},"PeriodicalIF":3.5,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11491988/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142463899","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":"Interventions for people with perceptual disorders after stroke: the PIONEER scoping review, Cochrane systematic review and priority setting project.","authors":"Christine Hazelton, Alex Todhunter-Brown, Pauline Campbell, Katie Thomson, Donald J Nicolson, Kris McGill, Charlie Sy Chung, Liam Dorris, David C Gillespie, Susan M Hunter, Linda J Williams, Marian C Brady","doi":"10.3310/WGJT3471","DOIUrl":"10.3310/WGJT3471","url":null,"abstract":"<p><strong>Background: </strong>Stroke often affects recognition and interpretation of information from our senses, resulting in perceptual disorders. Evidence to inform treatment is unclear.</p><p><strong>Objective: </strong>To determine the breadth and effectiveness of interventions for stroke-related perceptual disorders and identify priority research questions.</p><p><strong>Methods: </strong>We undertook a scoping review and then Cochrane systematic review. Definitions, outcome prioritisation, data interpretation and research prioritisation were coproduced with people who had perceptual disorders post stroke and healthcare professionals. We systematically searched electronic databases (including MEDLINE, EMBASE, inception to August 2021) and grey literature. We included studies (any design) of interventions for people with hearing, smell, somatosensation, taste, touch or visual perception disorders following stroke. Abstracts and full texts were independently dual reviewed. Data were tabulated, synthesised narratively and mapped by availability, sense and interventions. Research quality was not evaluated. Our Cochrane review synthesised the randomised controlled trial data, evaluated risk of bias (including randomisation, blinding, reporting) and meta-analysed intervention comparisons (vs. controls or no treatment) using RevMan 5.4. We judged certainty of evidence using grading of recommendations, assessment, development and evaluation. Activities of daily living after treatment was our primary outcome. Extended activities of daily living, quality of life, mental health and psychological well-being perceptual functional and adverse event data were also extracted.</p><p><strong>Results: </strong>We included 80 studies (<i>n</i> = 893): case studies (36/80) and randomised controlled trials (22/80). No stroke survivor or family stakeholder involvement was reported. Studies addressed visual (42.5%, 34/80), somatosensation (35%, 28/80), auditory (8.7%, 7/80) and tactile (7.5%, 6/80) perceptual disorders; some studies focused on 'mixed perceptual disorders' (6.2%, 5/80 such as taste-smell disorders). We identified 93 pharmacological, non-invasive brain stimulation or rehabilitation (restitution, substitution, compensation or mixed) interventions. Details were limited. Studies commonly measured perceptual (75%, 60/80), motor-sensorimotor (40%, 32/80) activities of daily living (22.5%, 18/80) or sensory function (15%, 12/80) outcomes.</p><p><strong>Cochrane systematic review: </strong>We included 18 randomised controlled trials (<i>n</i> = 541) addressing tactile (3 randomised controlled trials; <i>n</i> = 70), somatosensory (7 randomised controlled trials; <i>n</i> = 196), visual (7 randomised controlled trials; <i>n</i> = 225) and mixed tactile-somatosensory (1 randomised controlled trial; <i>n</i> = 50) disorders. None addressed hearing, taste or smell disorders. One non-invasive brain stimulation, one compensation, 25 restitution and 4 mixed int","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 69","pages":"1-141"},"PeriodicalIF":3.5,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11586814/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142562719","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":"Take-home naloxone in multicentre emergency settings: the TIME feasibility cluster RCT.","authors":"Helen Snooks, Jonathan Benger, Fiona Bell, Sarah Black, Simon Dixon, Helena Emery, Bridie Angela Evans, Gordon Fuller, Rebecca Hoskins, Jane Hughes, Jenna Jones, Matthew Jones, Sasha Johnston, Jaqui Long, Chris Moore, Rakshita Parab, Richard Pilbery, Fiona C Sampson, Alan Watkins","doi":"10.3310/YNRC8249","DOIUrl":"10.3310/YNRC8249","url":null,"abstract":"<p><strong>Background: </strong>Opioids kill more people than any other drug. Naloxone is an opioid antagonist which can be distributed in take-home 'kits' for peer administration (take-home naloxone).</p><p><strong>Aim: </strong>To determine the feasibility of carrying out a definitive randomised controlled trial of take-home naloxone in emergency settings.</p><p><strong>Design: </strong>We used Welsh routine data (2015-21) to test the feasibility of developing a discriminant function to identify people at high risk of fatal opioid overdose. We carried out a cluster randomised controlled trial and qualitative study to examine experiences of service users and providers. We assessed feasibility of intervention and trial methods against predetermined progression criteria related to: site sign-up, staff trained, identification of eligible patients, proportion given kits, identification of people who died of opioid poisoning, data linkage and retrieval of outcomes.</p><p><strong>Setting: </strong>This study was carried out in the emergency environment; sites comprised an emergency department and associated ambulance service catchment area.</p><p><strong>Participants: </strong>At intervention sites, we invited emergency department clinicians and paramedics to participate. We recruited adult patients who arrived at the emergency department or were attended to by ambulance paramedics for a problem related to opioid use with capacity to consent to receiving the take-home naloxone and related training.</p><p><strong>Interventions: </strong>Usual care comprised basic life support plus naloxone by paramedics or emergency department staff. The take-home naloxone intervention was offered in addition to usual care, with guidance for recipients on basic life support, the importance of calling the emergency services, duration of effect, safety and legality of naloxone administration.</p><p><strong>Discriminant function: </strong>With low numbers of opioid-related deaths (1105/3,227,396) and a high proportion having no contact with health services in the year before death, the predictive link between death and opioid-related healthcare events was weak. Logistic regression models indicated we would need to monitor one-third of the population to capture 75% of the decedents from opioid overdose in 1-year follow-up.</p><p><strong>Randomised controlled trial: </strong>Four sites participated in the trial and 299 of 687 (44%) eligible clinical staff were trained. Sixty take-home naloxone kits were supplied to patients during 1-year recruitment. Eligible patients were not offered take-home naloxone kits 164 times: 'forgot' (<i>n</i> = 136); 'too busy' (<i>n</i> = 15); suspected intentional overdose (<i>n</i> = 3).</p><p><strong>Qualitative interviews: </strong>Service users had high levels of knowledge about take-home naloxone. They were supportive of the intervention but noted concerns about opioid withdrawal and resistance to attending hospital for an overdose. Servi","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 74","pages":"1-69"},"PeriodicalIF":3.5,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11586806/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142564365","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 effect of two speech and language approaches on speech problems in people with Parkinson's disease: the PD COMM RCT.","authors":"Catherine M Sackley, Caroline Rick, Marian C Brady, Christopher Burton, Sue Jowett, Smitaa Patel, Rebecca Woolley, Patricia Masterson-Algar, Avril Nicoll, Christina H Smith, Zainab Abdali, Natalie Ives, Gillian Beaton, Sylvia Dickson, Ryan Ottridge, Helen Nankervis, Carl E Clarke","doi":"10.3310/ADWP8001","DOIUrl":"10.3310/ADWP8001","url":null,"abstract":"<p><strong>Background: </strong>Speech impairments are common with Parkinson's disease (reported prevalence 68%), increasing conversational demands, reliance on family and social withdrawal.</p><p><strong>Objective(s): </strong>The PD COMM trial compared the clinical and cost-effectiveness of two speech and language therapy approaches: Lee Silverman Voice Treatment LOUD and National Health Service speech and language therapy for the treatment of speech or voice problems in people with Parkinson's disease to no speech and language therapy (control) and against each other.</p><p><strong>Design: </strong>PD COMM is a phase III, multicentre, three-arm, unblinded, randomised controlled trial. Participants were randomised in a 1 : 1 : 1 ratio to control, National Health Service speech and language therapy or Lee Silverman Voice Treatment LOUD via a central computer-generated programme, using a minimisation procedure with a random element, to ensure allocation concealment. Mixed-methods process and health economic evaluations were conducted.</p><p><strong>Setting: </strong>United Kingdom outpatient and home settings.</p><p><strong>Participants: </strong>People with idiopathic Parkinson's disease, with self-reported or carer-reported speech or voice problems. We excluded people with dementia, laryngeal pathology and those within 24 months of previous speech and language therapy.</p><p><strong>Interventions: </strong>The Lee Silverman Voice Treatment LOUD intervention included maximum effort drills and high-effort speech production tasks delivered over four 50-minute therapist-led personalised sessions per week, for 4 weeks with prescribed daily home practice. National Health Service speech and language therapy content and dosage reflected local non-Lee Silverman Voice Treatment speech and language therapy practices, usually 1 hour, once weekly, for 6 weeks. Trained, experienced speech and language therapists or assistants provided interventions. The control was no speech and language therapy until the trial was completed.</p><p><strong>Main outcome measures: </strong>Primary outcome: Voice Handicap Index total score at 3 months. Secondary outcomes: Voice Handicap Index subscales, Parkinson's Disease Questionnaire-39; Questionnaire on Acquired Speech Disorders; EuroQol-5D-5L; ICEpop Capabilities Measure for Older Adults; Parkinson's Disease Questionnaire - Carers; resource utilisation; and adverse events. Assessments were completed pre-randomisation and at 3, 6 and 12 months post randomisation.</p><p><strong>Results: </strong>Three hundred and eighty-eight participants were randomised to Lee Silverman Voice Treatment LOUD (<i>n</i> = 130), National Health Service speech and language therapy (<i>n</i> = 129) and control (<i>n</i> = 129). The impact of voice problems at 3 months after randomisation was lower for Lee Silverman Voice Treatment LOUD participants than control [-8.0 (99% confidence interval: -13.3, -2.6); <i>p</i> = 0.001]. There was no evidence","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 58","pages":"1-141"},"PeriodicalIF":3.5,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11474952/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142371695","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":"Preventive drug treatments for adults with chronic migraine: a systematic review with economic modelling.","authors":"Hema Mistry, Seyran Naghdi, Anna Brown, Sophie Rees, Jason Madan, Amy Grove, Saval Khanal, Callum Duncan, Manjit Matharu, Andrew Cooklin, Aiva Aksentyte, Natasha Davies, Martin Underwood","doi":"10.3310/AYWA5297","DOIUrl":"10.3310/AYWA5297","url":null,"abstract":"<p><strong>Background: </strong>Chronic migraine is a disabling condition, affecting 2-4% of adults globally. With the introduction of expensive calcitonin gene-related peptide monoclonal antibodies, it is timely to compare the clinical effectiveness and cost-effectiveness of preventive drugs for chronic migraine.</p><p><strong>Objective: </strong>To assess the clinical effectiveness and cost-effectiveness of medications used for chronic migraine through systematic reviews and economic modelling.</p><p><strong>Eligibility criteria: </strong>Randomised controlled trials of drug treatments for efficacy with > 100 participants with chronic migraine per arm; for adverse events > 100 participants with episodic or chronic migraine per arm. Previous economic analyses of preventive drugs for chronic migraine.</p><p><strong>Data sources: </strong>Eight databases.</p><p><strong>Reviews methods: </strong>Systematic reviews, network meta-analysis and economic modelling.</p><p><strong>Outcomes: </strong>Monthly headache days, monthly migraine days, headache-related quality of life, cost-effectiveness.</p><p><strong>Results: </strong>We found 51 individual articles, reporting 11 randomised controlled trials, testing 6 drugs (topiramate, Botox, eptinezumab, erenumab, fremanezumab, galcanezumab), versus placebo, on 7352 adults with chronic migraine. Calcitonin gene-related peptide monoclonal antibodies, Botox and topiramate reduced headache/migraine days by 2.0-2.5, just under two, or by less than 1.5 days per month, respectively. In the network meta-analysis, eptinezumab 300 mg and fremanezumab monthly ranked in first place in both monthly headache day and monthly migraine day analyses. The calcitonin gene-related peptide monoclonal antibodies were consistently the best choices for headache/migraine days and headache-related quality of life. Topiramate was very unlikely to be the best choice for headache/migraine days and headache-related quality of life when compared to calcitonin gene-related peptide monoclonal antibodies or Botox. We found no trials of the commonly used drugs, such as propranolol or amitriptyline, to include in the analysis. The adverse events review included 40 randomised controlled trials with 25,891 participants; 3 additional drugs, amitriptyline, atogepant and rimegepant, were included. There were very few serious adverse events - none of which were linked to the use of these medications. Adverse events were common. Most people using some calcitonin gene-related peptide monoclonal antibodies reported injection site issues; and people using topiramate or amitriptyline had nervous system or gastrointestinal issues. The cost-effectiveness review identified 16 studies evaluating chronic migraine medications in adults. The newer, injected drugs are more costly than the oral preventatives, but they were cost-effective. Our economic model showed that topiramate was the least costly option and had the fewest quality-adjusted life-year gains, whe","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 63","pages":"1-329"},"PeriodicalIF":3.5,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11474956/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142371698","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":"MRI software and cognitive fusion biopsies in people with suspected prostate cancer: a systematic review, network meta-analysis and cost-effectiveness analysis.","authors":"Alexis Llewellyn, Thai Han Phung, Marta O Soares, Lucy Shepherd, David Glynn, Melissa Harden, Ruth Walker, Ana Duarte, Sofia Dias","doi":"10.3310/PLFG4210","DOIUrl":"10.3310/PLFG4210","url":null,"abstract":"<p><strong>Background: </strong>Magnetic resonance imaging localises cancer in the prostate, allowing for a targeted biopsy with or without transrectal ultrasound-guided systematic biopsy. Targeted biopsy methods include cognitive fusion, where prostate lesions suspicious on magnetic resonance imaging are targeted visually during live ultrasound, and software fusion, where computer software overlays the magnetic resonance imaging image onto the ultrasound in real time. The effectiveness and cost-effectiveness of software fusion technologies compared with cognitive fusion biopsy are uncertain.</p><p><strong>Objectives: </strong>To assess the clinical and cost-effectiveness of software fusion biopsy technologies in people with suspected localised and locally advanced prostate cancer. A systematic review was conducted to evaluate the diagnostic accuracy, clinical efficacy and practical implementation of nine software fusion devices compared to cognitive fusion biopsies, and with each other, in people with suspected prostate cancer. Comprehensive searches including MEDLINE, and Embase were conducted up to August 2022 to identify studies which compared software fusion and cognitive fusion biopsies in people with suspected prostate cancer. Risk of bias was assessed with quality assessment of diagnostic accuracy studies-comparative tool. A network meta-analysis comparing software and cognitive fusion with or without concomitant systematic biopsy, and systematic biopsy alone was conducted. Additional outcomes, including safety and usability, were synthesised narratively. A de novo decision model was developed to estimate the cost-effectiveness of targeted software fusion biopsy relative to cognitive fusion biopsy with or without concomitant systematic biopsy for prostate cancer identification in biopsy-naive people. Scenario analyses were undertaken to explore the robustness of the results to variation in the model data sources and alternative assumptions.</p><p><strong>Results: </strong>Twenty-three studies (3773 patients with software fusion, 2154 cognitive fusion) were included, of which 13 informed the main meta-analyses. Evidence was available for seven of the nine fusion devices specified in the protocol and at high risk of bias. The meta-analyses show that patients undergoing software fusion biopsy may have: (1) a lower probability of being classified as not having cancer, (2) similar probability of being classified as having non-clinically significant cancer (International Society of Urological Pathology grade 1) and (3) higher probability of being classified at higher International Society of Urological Pathology grades, particularly International Society of Urological Pathology 2. Similar results were obtained when comparing between same biopsy methods where both were combined with systematic biopsy. Evidence was insufficient to conclude whether any individual devices were superior to cognitive fusion, or whether some software fusion technologi","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 61","pages":"1-310"},"PeriodicalIF":3.5,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11472214/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142377785","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":"Antidepressants for pain management in adults with chronic pain: a network meta-analysis.","authors":"Hollie Birkinshaw, Claire Friedrich, Peter Cole, Christopher Eccleston, Marc Serfaty, Gavin Stewart, Simon White, Andrew Moore, David Phillippo, Tamar Pincus","doi":"10.3310/MKRT2948","DOIUrl":"10.3310/MKRT2948","url":null,"abstract":"<p><strong>Background: </strong>Chronic pain is common and costly. Antidepressants are prescribed to reduce pain. However, there has not been a network meta-analysis examining all antidepressants across all chronic pain conditions, so effectiveness and safety for most antidepressants for pain conditions remain unknown.</p><p><strong>Objective: </strong>To assess the efficacy and safety of antidepressants for chronic pain (except headache) in adults. Our primary outcomes were as follows: substantial pain relief (50%), pain intensity, mood and adverse events. Our secondary outcomes were as follows: moderate pain relief (30%), physical function, sleep, quality of life, Patient Global Impression of Change, serious adverse events and withdrawal.</p><p><strong>Design: </strong>This was a systematic review with a network meta-analysis. We searched CENTRAL, MEDLINE, EMBASE, CINAHL, LILACS, AMED and PsycINFO databases for randomised controlled trials of antidepressants for chronic pain conditions up until 4 January 2022. The review was registered in PROSPERO (CRD42020171855), and the protocol was published in the Cochrane Library (https://doi.org/10.1002/14651858.CD014682).</p><p><strong>Setting: </strong>We analysed trials from all settings.</p><p><strong>Participants: </strong>We included trials in which participants had chronic pain, defined as longer than 3 months, from any condition excluding headache.</p><p><strong>Interventions: </strong>We included all antidepressants.</p><p><strong>Main outcome measures: </strong>Our primary outcome was substantial pain relief, defined as a reduction ˃ 50%. We also measured pain intensity, mood and adverse events. Secondary measures included moderate pain relief (above 30% reduction), physical function, sleep, quality of life, Global Impression of Change, serious adverse events, and withdrawal from trial.</p><p><strong>Results: </strong>We identified 176 studies with a total of 28,664 participants. Most studies were placebo-controlled (<i>n</i> = 83) and parallel armed (<i>n</i> = 141). The most common pain conditions examined were fibromyalgia (59 studies), neuropathic pain (49 studies) and musculoskeletal pain (40 studies). The average length of randomised controlled trials was 10 weeks. Most studies measured short-term outcomes only and excluded people with low mood and other mental health conditions. Across efficacy outcomes, duloxetine was consistently the highest-ranked antidepressant with moderate- to high-certainty evidence. Standard dose was equally efficacious as high dose for the majority of outcomes. Milnacipran was often ranked as the next most efficacious antidepressant, although the certainty of evidence was lower than that for duloxetine. There was insufficient evidence to draw robust conclusions for the efficacy and safety of any other antidepressant for chronic pain.</p><p><strong>Limitations: </strong>The evidence for antidepressants other than duloxetine is poor. For duloxetine, it is not clea","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 62","pages":"1-155"},"PeriodicalIF":3.5,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11474957/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142377786","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":"Specific phobias in children with moderate to severe intellectual disabilities: SPIRIT, an adaptation and feasibility study.","authors":"Kylie M Gray, Magdalena M Apanasionok, Emma Scripps, Karen Bunning, Christine Burke, Malwina Filipczuk, Richard P Hastings, Ashley Liew, Rachel McNamara, Atiyya Nisar, Rebecca Playle, Tim Williams, Peter E Langdon","doi":"10.3310/LRWD7852","DOIUrl":"10.3310/LRWD7852","url":null,"abstract":"<p><strong>Background: </strong>There is a lack of interventions for specific phobia in children and adolescents with moderate to severe intellectual disabilities.</p><p><strong>Objectives: </strong>The objectives were to: (a) develop an intervention for specific phobia, together with an intervention fidelity checklist and logic model, and evaluate candidate outcome measures, together with parents/carers and clinicians; (b) describe treatment as usual; (c) model the intervention to determine the acceptability and feasibility for all stakeholders, judge the appropriateness of outcome measures, explore recruitment pathways, and examine the feasibility and acceptability of consent and associated processes; and (d) describe factors that facilitate or challenge the intervention.</p><p><strong>Design: </strong>Phase 1a: using consensus methods, an Intervention Development Group was established who met to develop the intervention, review candidate outcome measures and contribute to the development of the intervention fidelity checklists and logic model. Phase 1b: a national online survey was conducted with parents and professionals to describe treatment as usual. Phase 2: a single-group non-randomised feasibility study was designed to model the intervention and to test intervention feasibility and acceptability, outcome measures and aspects of the research process.</p><p><strong>Setting: </strong>Phase 2: participants were recruited from National Health Service community child learning disabilities teams and special schools in England. Treatment was delivered in the child learning disabilities teams.</p><p><strong>Participants: </strong>Children aged 5-15 years with moderate to severe learning disability and specific phobia, and their parents/carers.</p><p><strong>Interventions: </strong>The SPIRIT intervention comprised two half-day workshops and eight support sessions plus treatment as usual.</p><p><strong>Main outcomes: </strong>The feasibility and acceptability of the intervention and research processes, recruitment, outcome measure completion rates and acceptability, and intervention adherence. Parents completed all of the outcome measures, with very low rates of missing data. The recruitment of sites and participants was impacted by the COVID-19 pandemic.</p><p><strong>Results: </strong>The intervention was successfully developed and modelled with 15 participants with moderate to severe learning disabilities and their parents. The intervention was judged to be feasible and acceptable by parents/carers and therapists. Parents/carers and therapists suggested minor intervention revisions.</p><p><strong>Limitations: </strong>Randomisation was not modelled within this feasibility study, although the majority of parents and therapists indicated that this would be acceptable.</p><p><strong>Conclusions: </strong>The SPIRIT intervention and associated study processes were judged to be feasible and acceptable. The intervention requires minor revisions.</p><","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 64","pages":"1-118"},"PeriodicalIF":3.5,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11472212/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142377787","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":"Ceftazidime with avibactam for treating severe aerobic Gram-negative bacterial infections: technology evaluation to inform a novel subscription-style payment model.","authors":"Sue Harnan, Ben Kearns, Alison Scope, Laetitia Schmitt, Dina Jankovic, Jean Hamilton, Tushar Srivastava, Harry Hill, Chu Chang Ku, Shijie Ren, Claire Rothery, Laura Bojke, Mark Sculpher, Beth Woods","doi":"10.3310/YAPL9347","DOIUrl":"10.3310/YAPL9347","url":null,"abstract":"<p><strong>Background: </strong>To limit the use of antimicrobials without disincentivising the development of novel antimicrobials, there is interest in establishing innovative models that fund antimicrobials based on an evaluation of their value as opposed to the volumes used. The aim of this project was to evaluate the population-level health benefit of ceftazidime-avibactam in the NHS in England, for the treatment of severe aerobic Gram-negative bacterial infections when used within its licensed indications. The results were used to inform National Institute for Health and Care Excellence guidance in support of commercial discussions regarding contract value between the manufacturer and NHS England.</p><p><strong>Methods: </strong>The health benefit of ceftazidime-avibactam was first derived for a series of high-value clinical scenarios. These represented uses that were expected to have a significant impact on patients' mortality risks and health-related quality of life. Patient-level costs and health-related quality of life of ceftazidime-avibactam under various usage scenarios compared with alternative management strategies in the high-value clinical scenarios were quantified using decision modelling. Results were reported as incremental net health effects expressed in quality-adjusted life-years, which were scaled to 20-year population in quality-adjusted life-years using infection number forecasts based on data from Public Health England. The outcomes estimated for the high-value clinical scenarios were extrapolated to other expected uses for ceftazidime-avibactam.</p><p><strong>Results: </strong>The clinical effectiveness of ceftazidime-avibactam relative to its comparators was estimated by synthesising evidence on susceptibility of the pathogens of interest to the antimicrobials in a network meta-analysis. In the base case, ceftazidime-avibactam was associated with a statistically significantly higher susceptibility relative to colistin (odds ratio 7.24, 95% credible interval 2.58 to 20.94). The remainder of the treatments were associated with lower susceptibility than colistin (odds ratio < 1). The results were sensitive to the definition of resistance and the studies included in the analysis. In the base case, patient-level benefit of ceftazidime-avibactam was between 0.08 and 0.16 quality-adjusted life-years, depending on the site of infection and the usage scenario. There was a high degree of uncertainty surrounding the benefits of ceftazidime-avibactam across all subgroups, and the results were sensitive to assumptions in the meta-analysis used to estimate susceptibility. There was substantial uncertainty in the number of infections that are suitable for treatment with ceftazidime-avibactam, so population-level results are presented for a range of scenarios for the current infection numbers, the expected increases in infections over time, and rates of emergence of resistance. The population-level benefit varied substantially across","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 73","pages":"1-230"},"PeriodicalIF":3.5,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11586833/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142564364","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":"Behavioural interventions to treat anxiety in adults with autism and moderate to severe intellectual disabilities: the BEAMS-ID feasibility study.","authors":"Peter E Langdon, Magdalena M Apanasionok, Emma Scripps, Karen Bunning, Malwina Filipczuk, David Gillespie, Richard P Hastings, Andrew Jahoda, Rachel McNamara, Dheeraj Rai, Kylie M Gray","doi":"10.3310/MWTQ5721","DOIUrl":"10.3310/MWTQ5721","url":null,"abstract":"<p><strong>Background: </strong>Interventions for anxiety need to be adapted to meet the needs of autistic people with moderate to severe learning disabilities and successfully modelled before evidence about efficacy can be generated from clinical trials.</p><p><strong>Objectives: </strong>The objectives were to: (1) adapt a behavioural intervention for anxiety, develop an intervention fidelity checklist and logic model, and appraise candidate outcome measures, together with carers, autistic people, and clinicians, (2) characterise treatment-as-usual, (3) model the adapted intervention to determine the acceptability and feasibility for all stakeholders, judge the appropriateness of outcome measures, examine the feasibility and acceptability of consent and associated processes and (4) describe factors that facilitate or challenge intervention delivery.</p><p><strong>Design: </strong>This study had two phases. Phase 1a: using consensus methods, an intervention adaptation group was formed who met to adapt the intervention, appraise candidate outcome measures, and contribute to the development of the intervention fidelity checklists and logic model. Phase 1b: a national online survey was conducted with professionals to characterise treatment-as-usual. Phase 2: this was a single-group non-randomised feasibility study designed to model the intervention to test intervention feasibility and acceptability, outcome measures, and aspects of the research process.</p><p><strong>Setting: </strong>Participants were recruited from National Health Service community adult learning disabilities teams in England.</p><p><strong>Participants: </strong>Participants aged 16 and over with a diagnosis of autism, moderate to severe learning disabilities, an anxiety disorder, and a carer who was available to take part in the intervention. For those who lacked capacity to make a decision about taking part, a consultee had to provide advice that the participant should be included in the study.</p><p><strong>Interventions: </strong>The intervention comprised 12 sessions alongside treatment-as-usual.</p><p><strong>Main outcome measures: </strong>The feasibility and acceptability of the intervention and research processes, outcome measure completion rates, and intervention adherence.</p><p><strong>Results: </strong>The intervention was successfully adapted and modelled with 28 autistic participants with moderate to severe learning disabilities. The intervention was judged to be feasible and acceptable by autistic adults with learning disabilities, carers, and therapists. Carers and therapists suggested minor intervention revisions. Carers completed 100% of outcome measures and the missing data rate was low; however, they indicated that some of the questions were repetitive and said they had difficulty responding to some items. The use of the Mental Capacity Act, 2005, led to an average 5-week delay to participant enrolment. The accrual rate was affected by the COVID-19 pandemic ","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 72","pages":"1-147"},"PeriodicalIF":3.5,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11586821/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142564363","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}