Ratna Sohanpal, Hilary Pinnock, Liz Steed, Karen Heslop-Marshall, Moira J Kelly, Claire Chan, Vari Wileman, Amy Barradell, Clarisse Dibao-Dina, Paulino Font Gilabert, Andy Healey, Richard Hooper, Kristie-Marie Mammoliti, Stefan Priebe, Mike Roberts, Vickie Rowland, Sarah Waseem, Sally Singh, Melanie Smuk, Martin Underwood, Patrick White, Nahel Yaziji, Stephanie Jc Taylor
<p><strong>Background: </strong>People with chronic obstructive pulmonary disease have high levels of anxiety and depression, which is associated with increased morbidity and poor uptake of effective treatments, such as pulmonary rehabilitation. Cognitive-behavioural therapy improves mental health of people with long-term conditions and could potentially increase uptake of pulmonary rehabilitation, enabling synergies that could enhance the mental health of people with chronic obstructive pulmonary disease.</p><p><strong>Aim: </strong>Our aim was to develop and evaluate the clinical effectiveness and cost effectiveness of a tailored cognitive-behavioural approach intervention, which links into, and optimises the benefits of, routine pulmonary rehabilitation.</p><p><strong>Design: </strong>We carried out a pragmatic multicentre randomised controlled trial using a 1.25 : 1 ratio (intervention : control) with a parallel process evaluation, including assessment of fidelity.</p><p><strong>Setting: </strong>Twelve NHS trusts and five Clinical Commissioning Groups in England were recruited into the study. The intervention was delivered in participant's own home or at a local NHS facility, and by telephone.</p><p><strong>Participants: </strong>Between July 2017 and March 2020 we recruited adults with moderate/very severe chronic obstructive pulmonary disease and mild/moderate anxiety and/or depression, meeting eligibility criteria for assessment for pulmonary rehabilitation. Carers of participants were invited to participate.</p><p><strong>Intervention: </strong>The cognitive-behavioural approach intervention (i.e. six to eight 40- to 60-minute sessions plus telephone support throughout pulmonary rehabilitation) was delivered by 31 trained respiratory healthcare professionals to participants prior to commencing pulmonary rehabilitation. Usual care included routine pulmonary rehabilitation referral.</p><p><strong>Main outcome measures: </strong>Co-primary outcomes were Hospital Anxiety and Depression Scale - anxiety and Hospital Anxiety and Depression Scale - depression at 6 months post randomisation. Secondary outcomes at 6 and 12 months included health-related quality of life, smoking status, uptake of pulmonary rehabilitation and healthcare use.</p><p><strong>Results: </strong>We analysed results from 423 randomised participants (intervention, <i>n</i> = 242; control, <i>n</i> = 181). Forty-three carers participated. Follow-up at 6 and 12 months was 93% and 82%, respectively. Despite good fidelity for intervention delivery, mean between-group differences in Hospital Anxiety and Depression Scale at 6 months ruled out clinically important effects (Hospital Anxiety and Depression Scale - anxiety mean difference -0.60, 95% confidence interval -1.40 to 0.21; Hospital Anxiety and Depression Scale - depression mean difference -0.66, 95% confidence interval -1.39 to 0.07), with similar results at 12 months. There were no between-group differences in any of the
{"title":"A tailored psychological intervention for anxiety and depression management in people with chronic obstructive pulmonary disease: TANDEM RCT and process evaluation.","authors":"Ratna Sohanpal, Hilary Pinnock, Liz Steed, Karen Heslop-Marshall, Moira J Kelly, Claire Chan, Vari Wileman, Amy Barradell, Clarisse Dibao-Dina, Paulino Font Gilabert, Andy Healey, Richard Hooper, Kristie-Marie Mammoliti, Stefan Priebe, Mike Roberts, Vickie Rowland, Sarah Waseem, Sally Singh, Melanie Smuk, Martin Underwood, Patrick White, Nahel Yaziji, Stephanie Jc Taylor","doi":"10.3310/PAWA7221","DOIUrl":"10.3310/PAWA7221","url":null,"abstract":"<p><strong>Background: </strong>People with chronic obstructive pulmonary disease have high levels of anxiety and depression, which is associated with increased morbidity and poor uptake of effective treatments, such as pulmonary rehabilitation. Cognitive-behavioural therapy improves mental health of people with long-term conditions and could potentially increase uptake of pulmonary rehabilitation, enabling synergies that could enhance the mental health of people with chronic obstructive pulmonary disease.</p><p><strong>Aim: </strong>Our aim was to develop and evaluate the clinical effectiveness and cost effectiveness of a tailored cognitive-behavioural approach intervention, which links into, and optimises the benefits of, routine pulmonary rehabilitation.</p><p><strong>Design: </strong>We carried out a pragmatic multicentre randomised controlled trial using a 1.25 : 1 ratio (intervention : control) with a parallel process evaluation, including assessment of fidelity.</p><p><strong>Setting: </strong>Twelve NHS trusts and five Clinical Commissioning Groups in England were recruited into the study. The intervention was delivered in participant's own home or at a local NHS facility, and by telephone.</p><p><strong>Participants: </strong>Between July 2017 and March 2020 we recruited adults with moderate/very severe chronic obstructive pulmonary disease and mild/moderate anxiety and/or depression, meeting eligibility criteria for assessment for pulmonary rehabilitation. Carers of participants were invited to participate.</p><p><strong>Intervention: </strong>The cognitive-behavioural approach intervention (i.e. six to eight 40- to 60-minute sessions plus telephone support throughout pulmonary rehabilitation) was delivered by 31 trained respiratory healthcare professionals to participants prior to commencing pulmonary rehabilitation. Usual care included routine pulmonary rehabilitation referral.</p><p><strong>Main outcome measures: </strong>Co-primary outcomes were Hospital Anxiety and Depression Scale - anxiety and Hospital Anxiety and Depression Scale - depression at 6 months post randomisation. Secondary outcomes at 6 and 12 months included health-related quality of life, smoking status, uptake of pulmonary rehabilitation and healthcare use.</p><p><strong>Results: </strong>We analysed results from 423 randomised participants (intervention, <i>n</i> = 242; control, <i>n</i> = 181). Forty-three carers participated. Follow-up at 6 and 12 months was 93% and 82%, respectively. Despite good fidelity for intervention delivery, mean between-group differences in Hospital Anxiety and Depression Scale at 6 months ruled out clinically important effects (Hospital Anxiety and Depression Scale - anxiety mean difference -0.60, 95% confidence interval -1.40 to 0.21; Hospital Anxiety and Depression Scale - depression mean difference -0.66, 95% confidence interval -1.39 to 0.07), with similar results at 12 months. There were no between-group differences in any of the ","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 1","pages":"1-129"},"PeriodicalIF":3.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017633/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139478396","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ruth M Mackenzie, Abdulmajid Ali, Duff Bruce, Julie Bruce, Ian Ford, Nicola Greenlaw, Eleanor Grieve, Mike Lean, Robert S Lindsay, Joanne O'Donnell, Naveed Sattar, Sally Stewart, Jennifer Logue
<p><strong>Background: </strong>Bariatric surgery is a common procedure worldwide for the treatment of severe obesity and associated comorbid conditions but there is a lack of evidence as to medium-term safety and effectiveness outcomes in a United Kingdom setting.</p><p><strong>Objective: </strong>To establish the clinical outcomes and adverse events of different bariatric surgical procedures, their impact on quality of life and the effect on comorbidities.</p><p><strong>Design: </strong>Prospective observational cohort study.</p><p><strong>Setting: </strong>National Health Service secondary care and private practice in Scotland, United Kingdom.</p><p><strong>Participants: </strong>Adults (age >16 years) undergoing their first bariatric surgery procedure.</p><p><strong>Main outcome measures: </strong>Change in weight, hospital length of stay, readmission and reoperation rate, mortality, diabetes outcomes (HbA1c, medications), quality of life, anxiety, depression.</p><p><strong>Data sources: </strong>Patient-reported outcome measures, hospital records, national electronic health records (Scottish Morbidity Record 01, Scottish Care Information Diabetes, National Records Scotland, Prescription Information System).</p><p><strong>Results: </strong>Between December 2013 and February 2017, 548 eligible patients were approached and 445 participants were enrolled in the study. Of those, 335 had bariatric surgery and 1 withdrew from the study. Mean age was 46.0 (9.2) years, 74.7% were female and the median body mass index was 46.4 (42.4; 52.0) kg/m<sup>2</sup>. Weight was available for 128 participants at 3 years: mean change was -19.0% (±14.1) from the operation and -24.2% (±12.8) from the start of the preoperative weight-management programme. One hundred and thirty-nine (41.4%) participants were readmitted to hospital in the same or subsequent 35 months post surgery, 18 (5.4% of the operated cohort) had a reoperation or procedure considered to be related to bariatric surgery gastrointestinal complications or revisions. Fewer than five participants (<2%) died during follow-up. HbA1c was available for 93/182 and diabetes medications for 139/182 participants who had type 2 diabetes prior to surgery; HbA1c mean change was -5.72 (±16.71) (<i>p</i> = 0.001) mmol/mol and 65.5% required no diabetes medications (<i>p</i> < 0.001) at 3 years post surgery. Physical quality of life, available for 101/335 participants, improved in the 3 years post surgery, mean change in Rand 12-item Short Form Survey physical component score 8.32 (±8.95) (<i>p</i> < 0.001); however, there was no change in the prevalence of anxiety or depression.</p><p><strong>Limitations: </strong>Due to low numbers of bariatric surgery procedures in Scotland, recruitment was stopped before achieving the intended 2000 participants and follow-up was reduced from 10 years to 3 years.</p><p><strong>Conclusions: </strong>Bariatric surgery is a safe and effective treatment for obesity. Patients in Scotl
{"title":"Clinical outcomes and adverse events of bariatric surgery in adults with severe obesity in Scotland: the SCOTS observational cohort study.","authors":"Ruth M Mackenzie, Abdulmajid Ali, Duff Bruce, Julie Bruce, Ian Ford, Nicola Greenlaw, Eleanor Grieve, Mike Lean, Robert S Lindsay, Joanne O'Donnell, Naveed Sattar, Sally Stewart, Jennifer Logue","doi":"10.3310/UNAW6331","DOIUrl":"10.3310/UNAW6331","url":null,"abstract":"<p><strong>Background: </strong>Bariatric surgery is a common procedure worldwide for the treatment of severe obesity and associated comorbid conditions but there is a lack of evidence as to medium-term safety and effectiveness outcomes in a United Kingdom setting.</p><p><strong>Objective: </strong>To establish the clinical outcomes and adverse events of different bariatric surgical procedures, their impact on quality of life and the effect on comorbidities.</p><p><strong>Design: </strong>Prospective observational cohort study.</p><p><strong>Setting: </strong>National Health Service secondary care and private practice in Scotland, United Kingdom.</p><p><strong>Participants: </strong>Adults (age >16 years) undergoing their first bariatric surgery procedure.</p><p><strong>Main outcome measures: </strong>Change in weight, hospital length of stay, readmission and reoperation rate, mortality, diabetes outcomes (HbA1c, medications), quality of life, anxiety, depression.</p><p><strong>Data sources: </strong>Patient-reported outcome measures, hospital records, national electronic health records (Scottish Morbidity Record 01, Scottish Care Information Diabetes, National Records Scotland, Prescription Information System).</p><p><strong>Results: </strong>Between December 2013 and February 2017, 548 eligible patients were approached and 445 participants were enrolled in the study. Of those, 335 had bariatric surgery and 1 withdrew from the study. Mean age was 46.0 (9.2) years, 74.7% were female and the median body mass index was 46.4 (42.4; 52.0) kg/m<sup>2</sup>. Weight was available for 128 participants at 3 years: mean change was -19.0% (±14.1) from the operation and -24.2% (±12.8) from the start of the preoperative weight-management programme. One hundred and thirty-nine (41.4%) participants were readmitted to hospital in the same or subsequent 35 months post surgery, 18 (5.4% of the operated cohort) had a reoperation or procedure considered to be related to bariatric surgery gastrointestinal complications or revisions. Fewer than five participants (<2%) died during follow-up. HbA1c was available for 93/182 and diabetes medications for 139/182 participants who had type 2 diabetes prior to surgery; HbA1c mean change was -5.72 (±16.71) (<i>p</i> = 0.001) mmol/mol and 65.5% required no diabetes medications (<i>p</i> < 0.001) at 3 years post surgery. Physical quality of life, available for 101/335 participants, improved in the 3 years post surgery, mean change in Rand 12-item Short Form Survey physical component score 8.32 (±8.95) (<i>p</i> < 0.001); however, there was no change in the prevalence of anxiety or depression.</p><p><strong>Limitations: </strong>Due to low numbers of bariatric surgery procedures in Scotland, recruitment was stopped before achieving the intended 2000 participants and follow-up was reduced from 10 years to 3 years.</p><p><strong>Conclusions: </strong>Bariatric surgery is a safe and effective treatment for obesity. Patients in Scotl","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"28 7","pages":"1-115"},"PeriodicalIF":3.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017628/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139722326","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Olalekan A Uthman, Rachel Court, Seun Anjorin, Jodie Enderby, Lena Al-Khudairy, Chidozie Nduka, Hema Mistry, G J Melendez-Torres, Sian Taylor-Phillips, Aileen Clarke
Background: The aim of the study was to investigate the potential effect of different structural interventions for preventing cardiovascular disease.
Methods: Medline and EMBASE were searched for peer-reviewed simulation-based studies of structural interventions for prevention of cardiovascular disease. We performed a systematic narrative synthesis.
Results: A total of 54 studies met the inclusion criteria. Diet, nutrition, tobacco and alcohol control and other programmes are among the policy simulation models explored. Food tax and subsidies, healthy food and lifestyles policies, palm oil tax, processed meat tax, reduction in ultra-processed foods, supplementary nutrition assistance programmes, stricter food policy and subsidised community-supported agriculture were among the diet and nutrition initiatives. Initiatives to reduce tobacco and alcohol use included a smoking ban, a national tobacco control initiative and a tax on alcohol. Others included the NHS Health Check, WHO 25 × 25 and air quality management policy.
Future work and limitations: There is significant heterogeneity in simulation models, making comparisons of output data impossible. While policy interventions typically include a variety of strategies, none of the models considered possible interrelationships between multiple policies or potential interactions. Research that investigates dose-response interactions between numerous modifications as well as longer-term clinical outcomes can help us better understand the potential impact of policy-level interventions.
Conclusions: The reviewed studies underscore the potential of structural interventions in addressing cardiovascular diseases. Notably, interventions in areas such as diet, tobacco, and alcohol control demonstrate a prospective decrease in cardiovascular incidents. However, to realize the full potential of such interventions, there is a pressing need for models that consider the interplay and cumulative impacts of multiple policies. Rigorous research into holistic and interconnected interventions will pave the way for more effective policy strategies in the future.
Study registration: The study is registered as PROSPERO CRD42019154836.
Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 17/148/05.
{"title":"The potential impact of policies and structural interventions in reducing cardiovascular disease and mortality: a systematic review of simulation-based studies.","authors":"Olalekan A Uthman, Rachel Court, Seun Anjorin, Jodie Enderby, Lena Al-Khudairy, Chidozie Nduka, Hema Mistry, G J Melendez-Torres, Sian Taylor-Phillips, Aileen Clarke","doi":"10.3310/NMFG0214","DOIUrl":"https://doi.org/10.3310/NMFG0214","url":null,"abstract":"<p><strong>Background: </strong>The aim of the study was to investigate the potential effect of different structural interventions for preventing cardiovascular disease.</p><p><strong>Methods: </strong>Medline and EMBASE were searched for peer-reviewed simulation-based studies of structural interventions for prevention of cardiovascular disease. We performed a systematic narrative synthesis.</p><p><strong>Results: </strong>A total of 54 studies met the inclusion criteria. Diet, nutrition, tobacco and alcohol control and other programmes are among the policy simulation models explored. Food tax and subsidies, healthy food and lifestyles policies, palm oil tax, processed meat tax, reduction in ultra-processed foods, supplementary nutrition assistance programmes, stricter food policy and subsidised community-supported agriculture were among the diet and nutrition initiatives. Initiatives to reduce tobacco and alcohol use included a smoking ban, a national tobacco control initiative and a tax on alcohol. Others included the NHS Health Check, WHO 25 × 25 and air quality management policy.</p><p><strong>Future work and limitations: </strong>There is significant heterogeneity in simulation models, making comparisons of output data impossible. While policy interventions typically include a variety of strategies, none of the models considered possible interrelationships between multiple policies or potential interactions. Research that investigates dose-response interactions between numerous modifications as well as longer-term clinical outcomes can help us better understand the potential impact of policy-level interventions.</p><p><strong>Conclusions: </strong>The reviewed studies underscore the potential of structural interventions in addressing cardiovascular diseases. Notably, interventions in areas such as diet, tobacco, and alcohol control demonstrate a prospective decrease in cardiovascular incidents. However, to realize the full potential of such interventions, there is a pressing need for models that consider the interplay and cumulative impacts of multiple policies. Rigorous research into holistic and interconnected interventions will pave the way for more effective policy strategies in the future.</p><p><strong>Study registration: </strong>The study is registered as PROSPERO CRD42019154836.</p><p><strong>Funding: </strong>This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 17/148/05.</p>","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":" ","pages":"1-32"},"PeriodicalIF":3.6,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138884848","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Charles C Roehr, Andrew Sj Marshall, Alexandra Scrivens, Manish Sadarangani, Rachel Williams, Jean Yong, Louise Linsell, Virginia Chiocchia, Jennifer L Bell, Caz Stokes, Patricia Santhanadass, Ian Nicoll, Eleri Adams, Andrew King, David Murray, Ursula Bowler, Kayleigh Stanbury, Edmund Juszczak
<p><strong>Background: </strong>Lumbar puncture is an essential tool for diagnosing meningitis. Neonatal lumbar puncture, although frequently performed, has low success rates (50-60%). Standard technique includes lying infants on their side and removing the stylet 'late', that is, after the needle is thought to have entered the cerebrospinal fluid. Modifications to this technique include holding infants in the sitting position and removing the stylet 'early', that is, following transection of the skin. To the best of our knowledge, modified techniques have not previously been tested in adequately powered trials.</p><p><strong>Objectives: </strong>The aim of the Neonatal Champagne Lumbar punctures Every time - An RCT (NeoCLEAR) trial was to compare two modifications to standard lumbar puncture technique, that is, use of the lying position rather than the sitting position and of 'early' rather than 'late' stylet removal, in terms of success rates and short-term clinical, resource and safety outcomes.</p><p><strong>Methods: </strong>This was a multicentre 2 × 2 factorial pragmatic non-blinded randomised controlled trial. Infants requiring lumbar puncture (with a working weight ≥ 1000 g and corrected gestational age from 27<sup>+0</sup> to 44<sup>+0</sup> weeks), and whose parents provided written consent, were randomised by web-based allocation to lumbar puncture (1) in the sitting or lying position and (2) with early or late stylet removal. The trial was powered to detect a 10% absolute risk difference in the primary outcome, that is, the percentage of infants with a successful lumbar puncture (cerebrospinal fluid containing < 10,000 red cells/mm<sup>3</sup>). The primary outcome was analysed by modified intention to treat.</p><p><strong>Results: </strong>Of 1082 infants randomised (sitting with early stylet removal, <i>n</i> = 275; sitting with late stylet removal, <i>n</i> = 271; lying with early stylet removal, <i>n</i> = 274; lying with late stylet removal, <i>n</i> = 262), 1076 were followed up until discharge. Most infants were term born (950/1076, 88.3%) and were aged < 3 days (936/1076, 87.0%) with a working weight > 2.5 kg (971/1076, 90.2%). Baseline characteristics were balanced across groups. In terms of the primary outcome, the sitting position was significantly more successful than lying [346/543 (63.7%) vs. 307/533 (57.6%), adjusted risk ratio 1.10 (95% confidence interval 1.01 to 1.21); <i>p</i> = 0.029; number needed to treat = 16 (95% confidence interval 9 to 134)]. There was no significant difference in the primary outcome between early stylet removal and late stylet removal [338/545 (62.0%) vs. 315/531 (59.3%), adjusted risk ratio 1.04 (95% confidence interval 0.94 to 1.15); <i>p</i> = 0.447]. Resource consumption was similar in all groups, and all techniques were well tolerated and safe.</p><p><strong>Limitations: </strong>This trial predominantly recruited term-born infants who were < 3 days old, with working weights > 2.5 kg.
{"title":"Techniques to increase lumbar puncture success in newborn babies: the NeoCLEAR RCT.","authors":"Charles C Roehr, Andrew Sj Marshall, Alexandra Scrivens, Manish Sadarangani, Rachel Williams, Jean Yong, Louise Linsell, Virginia Chiocchia, Jennifer L Bell, Caz Stokes, Patricia Santhanadass, Ian Nicoll, Eleri Adams, Andrew King, David Murray, Ursula Bowler, Kayleigh Stanbury, Edmund Juszczak","doi":"10.3310/THJY0671","DOIUrl":"10.3310/THJY0671","url":null,"abstract":"<p><strong>Background: </strong>Lumbar puncture is an essential tool for diagnosing meningitis. Neonatal lumbar puncture, although frequently performed, has low success rates (50-60%). Standard technique includes lying infants on their side and removing the stylet 'late', that is, after the needle is thought to have entered the cerebrospinal fluid. Modifications to this technique include holding infants in the sitting position and removing the stylet 'early', that is, following transection of the skin. To the best of our knowledge, modified techniques have not previously been tested in adequately powered trials.</p><p><strong>Objectives: </strong>The aim of the Neonatal Champagne Lumbar punctures Every time - An RCT (NeoCLEAR) trial was to compare two modifications to standard lumbar puncture technique, that is, use of the lying position rather than the sitting position and of 'early' rather than 'late' stylet removal, in terms of success rates and short-term clinical, resource and safety outcomes.</p><p><strong>Methods: </strong>This was a multicentre 2 × 2 factorial pragmatic non-blinded randomised controlled trial. Infants requiring lumbar puncture (with a working weight ≥ 1000 g and corrected gestational age from 27<sup>+0</sup> to 44<sup>+0</sup> weeks), and whose parents provided written consent, were randomised by web-based allocation to lumbar puncture (1) in the sitting or lying position and (2) with early or late stylet removal. The trial was powered to detect a 10% absolute risk difference in the primary outcome, that is, the percentage of infants with a successful lumbar puncture (cerebrospinal fluid containing < 10,000 red cells/mm<sup>3</sup>). The primary outcome was analysed by modified intention to treat.</p><p><strong>Results: </strong>Of 1082 infants randomised (sitting with early stylet removal, <i>n</i> = 275; sitting with late stylet removal, <i>n</i> = 271; lying with early stylet removal, <i>n</i> = 274; lying with late stylet removal, <i>n</i> = 262), 1076 were followed up until discharge. Most infants were term born (950/1076, 88.3%) and were aged < 3 days (936/1076, 87.0%) with a working weight > 2.5 kg (971/1076, 90.2%). Baseline characteristics were balanced across groups. In terms of the primary outcome, the sitting position was significantly more successful than lying [346/543 (63.7%) vs. 307/533 (57.6%), adjusted risk ratio 1.10 (95% confidence interval 1.01 to 1.21); <i>p</i> = 0.029; number needed to treat = 16 (95% confidence interval 9 to 134)]. There was no significant difference in the primary outcome between early stylet removal and late stylet removal [338/545 (62.0%) vs. 315/531 (59.3%), adjusted risk ratio 1.04 (95% confidence interval 0.94 to 1.15); <i>p</i> = 0.447]. Resource consumption was similar in all groups, and all techniques were well tolerated and safe.</p><p><strong>Limitations: </strong>This trial predominantly recruited term-born infants who were < 3 days old, with working weights > 2.5 kg. ","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"27 33","pages":"1-97"},"PeriodicalIF":3.5,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017152/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139039793","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
John R Ingram, Janine Bates, Rebecca Cannings-John, Fiona Collier, Angela Gibbons, Ceri Harris, Kerenza Hood, Laura Howells, Rachel Howes, Paul Leighton, Muhammad Riaz, Jeremy Rodrigues, Helen Stanton, Kim S Thomas, Emma Thomas-Jones
<p><strong>Background: </strong>Hidradenitis suppurativa is a chronic inflammatory skin disease characterised by recurrent inflammatory lesions and skin tunnels in flexural sites such as the axilla. Deroofing of skin tunnels and laser treatment are standard hidradenitis suppurativa interventions in some countries but not yet introduced in the United Kingdom.</p><p><strong>Objective: </strong>To understand current hidradenitis suppurativa management pathways and what influences treatment choices to inform the design of future randomised controlled trials.</p><p><strong>Design: </strong>Prospective 12-month observational cohort study, including five treatment options, with nested qualitative interviews and an end-of-study consensus workshop.</p><p><strong>Setting: </strong>Ten United Kingdom hospitals with recruitment led by dermatology and plastic surgery departments.</p><p><strong>Participants: </strong>Adults with active hidradenitis suppurativa of any severity not adequately controlled by current treatment.</p><p><strong>Interventions: </strong>Oral doxycycline 200 mg once daily; oral clindamycin and rifampicin, both 300 mg twice daily for 10 weeks initially; laser treatment targeting the hair follicle (neodymium-doped yttrium aluminium garnet or alexandrite); deroofing; and conventional surgery.</p><p><strong>Main outcome measures: </strong>Primary outcome was the proportion of participants who are eligible, and hypothetically willing, to use the different treatment options. Secondary outcomes included proportion of participants choosing each of the study interventions, with reasons for their choices; proportion of participants who switched treatments; treatment fidelity; loss to follow-up rates over 12 months; and efficacy outcome estimates to inform outcome measure instrument responsiveness.</p><p><strong>Results: </strong>Between February 2020 and July 2021, 151 participants were recruited, with two pauses due to the COVID-19 pandemic. Follow-up rates were 89% and 83% after 3 and 6 months, decreasing to 70% and 44% at 9 and 12 months, respectively, because pandemic recruitment delays prevented all participants reaching their final review. Baseline demographics included an average age of 36 years, 81% female, 20% black, Asian or Caribbean, 64% current or ex-smokers and 86% with a raised body mass index. Some 69% had moderate disease, 19% severe disease and 13% mild disease. Regarding the study's primary outcome, laser treatment was the intervention with the highest proportion (69%) of participants who were eligible and hypothetically willing to receive treatment, followed by deroofing (58%), conventional surgery (54%), the combination of oral clindamycin and rifampicin (44%) and doxycycline (37%). Considering participant willingness in isolation, laser was ranked first choice by the greatest proportion (41%) of participants. The cohort study and qualitative study demonstrated that participant willingness to receive treatment was strongly inf
{"title":"Treatment of Hidradenitis Suppurativa Evaluation Study: the THESEUS prospective cohort study.","authors":"John R Ingram, Janine Bates, Rebecca Cannings-John, Fiona Collier, Angela Gibbons, Ceri Harris, Kerenza Hood, Laura Howells, Rachel Howes, Paul Leighton, Muhammad Riaz, Jeremy Rodrigues, Helen Stanton, Kim S Thomas, Emma Thomas-Jones","doi":"10.3310/HWNM2189","DOIUrl":"10.3310/HWNM2189","url":null,"abstract":"<p><strong>Background: </strong>Hidradenitis suppurativa is a chronic inflammatory skin disease characterised by recurrent inflammatory lesions and skin tunnels in flexural sites such as the axilla. Deroofing of skin tunnels and laser treatment are standard hidradenitis suppurativa interventions in some countries but not yet introduced in the United Kingdom.</p><p><strong>Objective: </strong>To understand current hidradenitis suppurativa management pathways and what influences treatment choices to inform the design of future randomised controlled trials.</p><p><strong>Design: </strong>Prospective 12-month observational cohort study, including five treatment options, with nested qualitative interviews and an end-of-study consensus workshop.</p><p><strong>Setting: </strong>Ten United Kingdom hospitals with recruitment led by dermatology and plastic surgery departments.</p><p><strong>Participants: </strong>Adults with active hidradenitis suppurativa of any severity not adequately controlled by current treatment.</p><p><strong>Interventions: </strong>Oral doxycycline 200 mg once daily; oral clindamycin and rifampicin, both 300 mg twice daily for 10 weeks initially; laser treatment targeting the hair follicle (neodymium-doped yttrium aluminium garnet or alexandrite); deroofing; and conventional surgery.</p><p><strong>Main outcome measures: </strong>Primary outcome was the proportion of participants who are eligible, and hypothetically willing, to use the different treatment options. Secondary outcomes included proportion of participants choosing each of the study interventions, with reasons for their choices; proportion of participants who switched treatments; treatment fidelity; loss to follow-up rates over 12 months; and efficacy outcome estimates to inform outcome measure instrument responsiveness.</p><p><strong>Results: </strong>Between February 2020 and July 2021, 151 participants were recruited, with two pauses due to the COVID-19 pandemic. Follow-up rates were 89% and 83% after 3 and 6 months, decreasing to 70% and 44% at 9 and 12 months, respectively, because pandemic recruitment delays prevented all participants reaching their final review. Baseline demographics included an average age of 36 years, 81% female, 20% black, Asian or Caribbean, 64% current or ex-smokers and 86% with a raised body mass index. Some 69% had moderate disease, 19% severe disease and 13% mild disease. Regarding the study's primary outcome, laser treatment was the intervention with the highest proportion (69%) of participants who were eligible and hypothetically willing to receive treatment, followed by deroofing (58%), conventional surgery (54%), the combination of oral clindamycin and rifampicin (44%) and doxycycline (37%). Considering participant willingness in isolation, laser was ranked first choice by the greatest proportion (41%) of participants. The cohort study and qualitative study demonstrated that participant willingness to receive treatment was strongly inf","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"27 30","pages":"1-107"},"PeriodicalIF":3.5,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017627/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139039792","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}
Ros Wade, Emily South, Sumayya Anwer, Sahar Sharif-Hurst, Melissa Harden, Helen Fulbright, Robert Hodgson, Sofia Dias, Mark Simmonds, Ian Rowe, Patricia Thornton, Alison Eastwood
<p><strong>Background: </strong>A wide range of ablative and non-surgical therapies are available for treating small hepatocellular carcinoma in patients with very early or early-stage disease and preserved liver function.</p><p><strong>Objective: </strong>To review and compare the effectiveness of all current ablative and non-surgical therapies for patients with small hepatocellular carcinoma (≤ 3 cm).</p><p><strong>Design: </strong>Systematic review and network meta-analysis.</p><p><strong>Data sources: </strong>Nine databases (March 2021), two trial registries (April 2021) and reference lists of relevant systematic reviews.</p><p><strong>Review methods: </strong>Eligible studies were randomised controlled trials of ablative and non-surgical therapies, versus any comparator, for small hepatocellular carcinoma. Randomised controlled trials were quality assessed using the Cochrane Risk of Bias 2 tool and mapped. The comparative effectiveness of therapies was assessed using network meta-analysis. A threshold analysis was used to identify which comparisons were sensitive to potential changes in the evidence. Where comparisons based on randomised controlled trial evidence were not robust or no randomised controlled trials were identified, a targeted systematic review of non-randomised, prospective comparative studies provided additional data for repeat network meta-analysis and threshold analysis. The feasibility of undertaking economic modelling was explored. A workshop with patients and clinicians was held to discuss the findings and identify key priorities for future research.</p><p><strong>Results: </strong>Thirty-seven randomised controlled trials (with over 3700 relevant patients) were included in the review. The majority were conducted in China or Japan and most had a high risk of bias or some risk of bias concerns. The results of the network meta-analysis were uncertain for most comparisons. There was evidence that percutaneous ethanol injection is inferior to radiofrequency ablation for overall survival (hazard ratio 1.45, 95% credible interval 1.16 to 1.82), progression-free survival (hazard ratio 1.36, 95% credible interval 1.11 to 1.67), overall recurrence (relative risk 1.19, 95% credible interval 1.02 to 1.39) and local recurrence (relative risk 1.80, 95% credible interval 1.19 to 2.71). Percutaneous acid injection was also inferior to radiofrequency ablation for progression-free survival (hazard ratio 1.63, 95% credible interval 1.05 to 2.51). Threshold analysis showed that further evidence could plausibly change the result for some comparisons. Fourteen eligible non-randomised studies were identified (<i>n</i> ≥ 2316); twelve had a high risk of bias so were not included in updated network meta-analyses. Additional non-randomised data, made available by a clinical advisor, were also included (<i>n</i> = 303). There remained a high level of uncertainty in treatment rankings after the network meta-analyses were updated. However, the upd
{"title":"Ablative and non-surgical therapies for early and very early hepatocellular carcinoma: a systematic review and network meta-analysis.","authors":"Ros Wade, Emily South, Sumayya Anwer, Sahar Sharif-Hurst, Melissa Harden, Helen Fulbright, Robert Hodgson, Sofia Dias, Mark Simmonds, Ian Rowe, Patricia Thornton, Alison Eastwood","doi":"10.3310/GK5221","DOIUrl":"10.3310/GK5221","url":null,"abstract":"<p><strong>Background: </strong>A wide range of ablative and non-surgical therapies are available for treating small hepatocellular carcinoma in patients with very early or early-stage disease and preserved liver function.</p><p><strong>Objective: </strong>To review and compare the effectiveness of all current ablative and non-surgical therapies for patients with small hepatocellular carcinoma (≤ 3 cm).</p><p><strong>Design: </strong>Systematic review and network meta-analysis.</p><p><strong>Data sources: </strong>Nine databases (March 2021), two trial registries (April 2021) and reference lists of relevant systematic reviews.</p><p><strong>Review methods: </strong>Eligible studies were randomised controlled trials of ablative and non-surgical therapies, versus any comparator, for small hepatocellular carcinoma. Randomised controlled trials were quality assessed using the Cochrane Risk of Bias 2 tool and mapped. The comparative effectiveness of therapies was assessed using network meta-analysis. A threshold analysis was used to identify which comparisons were sensitive to potential changes in the evidence. Where comparisons based on randomised controlled trial evidence were not robust or no randomised controlled trials were identified, a targeted systematic review of non-randomised, prospective comparative studies provided additional data for repeat network meta-analysis and threshold analysis. The feasibility of undertaking economic modelling was explored. A workshop with patients and clinicians was held to discuss the findings and identify key priorities for future research.</p><p><strong>Results: </strong>Thirty-seven randomised controlled trials (with over 3700 relevant patients) were included in the review. The majority were conducted in China or Japan and most had a high risk of bias or some risk of bias concerns. The results of the network meta-analysis were uncertain for most comparisons. There was evidence that percutaneous ethanol injection is inferior to radiofrequency ablation for overall survival (hazard ratio 1.45, 95% credible interval 1.16 to 1.82), progression-free survival (hazard ratio 1.36, 95% credible interval 1.11 to 1.67), overall recurrence (relative risk 1.19, 95% credible interval 1.02 to 1.39) and local recurrence (relative risk 1.80, 95% credible interval 1.19 to 2.71). Percutaneous acid injection was also inferior to radiofrequency ablation for progression-free survival (hazard ratio 1.63, 95% credible interval 1.05 to 2.51). Threshold analysis showed that further evidence could plausibly change the result for some comparisons. Fourteen eligible non-randomised studies were identified (<i>n</i> ≥ 2316); twelve had a high risk of bias so were not included in updated network meta-analyses. Additional non-randomised data, made available by a clinical advisor, were also included (<i>n</i> = 303). There remained a high level of uncertainty in treatment rankings after the network meta-analyses were updated. However, the upd","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"27 29","pages":"1-172"},"PeriodicalIF":3.5,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017143/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139039791","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}
Janet A Wilson, Tony Fouweather, Deborah D Stocken, Tara Homer, Catherine Haighton, Nikki Rousseau, James O'Hara, Luke Vale, Rebecca Wilson, Sonya Carnell, Scott Wilkes, Jill Morrison, Kim Ah-See, Sean Carrie, Claire Hopkins, Nicola Howe, Musheer Hussain, Lyndsay Lindley, Kenneth MacKenzie, Lorraine McSweeney, Hisham Mehanna, Christopher Raine, Ruby Smith Whelan, Frank Sullivan, Alexander von Wilamowitz-Moellendorff, Dawn Teare
<p><strong>Background: </strong>The place of tonsillectomy in the management of sore throat in adults remains uncertain.</p><p><strong>Objectives: </strong>To establish the clinical effectiveness and cost-effectiveness of tonsillectomy, compared with conservative management, for tonsillitis in adults, and to evaluate the impact of alternative sore throat patient pathways.</p><p><strong>Design: </strong>This was a multicentre, randomised controlled trial comparing tonsillectomy with conservative management. The trial included a qualitative process evaluation and an economic evaluation.</p><p><strong>Setting: </strong>The study took place at 27 NHS secondary care hospitals in Great Britain.</p><p><strong>Participants: </strong>A total of 453 eligible participants with recurrent sore throats were recruited to the main trial.</p><p><strong>Interventions: </strong>Patients were randomised on a 1 : 1 basis between tonsil dissection and conservative management (i.e. deferred surgery) using a variable block-stratified design, stratified by (1) centre and (2) severity.</p><p><strong>Main outcome measures: </strong>The primary outcome measure was the total number of sore throat days over 24 months following randomisation. The secondary outcome measures were the number of sore throat episodes and five characteristics from Sore Throat Alert Return, describing severity of the sore throat, use of medications, time away from usual activities and the Short Form questionnaire-12 items. Additional secondary outcomes were the Tonsil Outcome Inventory-14 total and subscales and Short Form questionnaire-12 items 6 monthly. Evaluation of the impact of alternative sore throat patient pathways by observation and statistical modelling of outcomes against baseline severity, as assessed by Tonsil Outcome Inventory-14 score at recruitment. The incremental cost per sore throat day avoided, the incremental cost per quality-adjusted life-year gained based on responses to the Short Form questionnaire-12 items and the incremental net benefit based on costs and responses to a contingent valuation exercise. A qualitative process evaluation examined acceptability of trial processes and ramdomised arms.</p><p><strong>Results: </strong>There was a median of 27 (interquartile range 12-52) sore throats over the 24-month follow-up. A smaller number of sore throats was reported in the tonsillectomy arm [median 23 (interquartile range 11-46)] than in the conservative management arm [median 30 (interquartile range 14-65)]. On an intention-to-treat basis, there were fewer sore throats in the tonsillectomy arm (incident rate ratio 0.53, 95% confidence interval 0.43 to 0.65). Sensitivity analyses confirmed this, as did the secondary outcomes. There were 52 episodes of post-operative haemorrhage reported in 231 participants undergoing tonsillectomy (22.5%). There were 47 re-admissions following tonsillectomy (20.3%), 35 relating to haemorrhage. On average, tonsillectomy was more costly and mor
{"title":"Tonsillectomy compared with conservative management in patients over 16 years with recurrent sore throat: the NATTINA RCT and economic evaluation.","authors":"Janet A Wilson, Tony Fouweather, Deborah D Stocken, Tara Homer, Catherine Haighton, Nikki Rousseau, James O'Hara, Luke Vale, Rebecca Wilson, Sonya Carnell, Scott Wilkes, Jill Morrison, Kim Ah-See, Sean Carrie, Claire Hopkins, Nicola Howe, Musheer Hussain, Lyndsay Lindley, Kenneth MacKenzie, Lorraine McSweeney, Hisham Mehanna, Christopher Raine, Ruby Smith Whelan, Frank Sullivan, Alexander von Wilamowitz-Moellendorff, Dawn Teare","doi":"10.3310/YKUR3660","DOIUrl":"10.3310/YKUR3660","url":null,"abstract":"<p><strong>Background: </strong>The place of tonsillectomy in the management of sore throat in adults remains uncertain.</p><p><strong>Objectives: </strong>To establish the clinical effectiveness and cost-effectiveness of tonsillectomy, compared with conservative management, for tonsillitis in adults, and to evaluate the impact of alternative sore throat patient pathways.</p><p><strong>Design: </strong>This was a multicentre, randomised controlled trial comparing tonsillectomy with conservative management. The trial included a qualitative process evaluation and an economic evaluation.</p><p><strong>Setting: </strong>The study took place at 27 NHS secondary care hospitals in Great Britain.</p><p><strong>Participants: </strong>A total of 453 eligible participants with recurrent sore throats were recruited to the main trial.</p><p><strong>Interventions: </strong>Patients were randomised on a 1 : 1 basis between tonsil dissection and conservative management (i.e. deferred surgery) using a variable block-stratified design, stratified by (1) centre and (2) severity.</p><p><strong>Main outcome measures: </strong>The primary outcome measure was the total number of sore throat days over 24 months following randomisation. The secondary outcome measures were the number of sore throat episodes and five characteristics from Sore Throat Alert Return, describing severity of the sore throat, use of medications, time away from usual activities and the Short Form questionnaire-12 items. Additional secondary outcomes were the Tonsil Outcome Inventory-14 total and subscales and Short Form questionnaire-12 items 6 monthly. Evaluation of the impact of alternative sore throat patient pathways by observation and statistical modelling of outcomes against baseline severity, as assessed by Tonsil Outcome Inventory-14 score at recruitment. The incremental cost per sore throat day avoided, the incremental cost per quality-adjusted life-year gained based on responses to the Short Form questionnaire-12 items and the incremental net benefit based on costs and responses to a contingent valuation exercise. A qualitative process evaluation examined acceptability of trial processes and ramdomised arms.</p><p><strong>Results: </strong>There was a median of 27 (interquartile range 12-52) sore throats over the 24-month follow-up. A smaller number of sore throats was reported in the tonsillectomy arm [median 23 (interquartile range 11-46)] than in the conservative management arm [median 30 (interquartile range 14-65)]. On an intention-to-treat basis, there were fewer sore throats in the tonsillectomy arm (incident rate ratio 0.53, 95% confidence interval 0.43 to 0.65). Sensitivity analyses confirmed this, as did the secondary outcomes. There were 52 episodes of post-operative haemorrhage reported in 231 participants undergoing tonsillectomy (22.5%). There were 47 re-admissions following tonsillectomy (20.3%), 35 relating to haemorrhage. On average, tonsillectomy was more costly and mor","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"27 31","pages":"1-195"},"PeriodicalIF":3.5,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017150/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139416847","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}
Peter S Blair, Grace J Young, Clare Clement, Padraig Dixon, Penny Seume, Jenny Ingram, Jodi Taylor, Jeremy Horwood, Patricia J Lucas, Christie Cabral, Nick A Francis, Elizabeth Beech, Martin Gulliford, Sam Creavin, Janet A Lane, Scott Bevan, Alastair D Hay
<p><strong>Background: </strong>Clinical uncertainty in primary care regarding the prognosis of children with respiratory tract infections contributes to the unnecessary use of antibiotics. Improved identification of children at low risk of future hospitalisation might reduce clinical uncertainty. A National Institute for Health and Care Research-funded 5-year programme (RP-PG-0608-10018) was used to develop and feasibility test an intervention.</p><p><strong>Objectives: </strong>The aim of the children with acute cough randomised controlled trial was to reduce antibiotic prescribing among children presenting with acute cough and respiratory tract infection without increasing hospital admission.</p><p><strong>Design: </strong>An efficient, pragmatic open-label, two-arm trial (with embedded qualitative and health economic analyses) using practice-level randomisation using routinely collected data as the primary outcome.</p><p><strong>Setting: </strong>General practitioner practices in England.</p><p><strong>Participants: </strong>General practitioner practices using the Egton Medical Information Systems<sup>®</sup> patient-record system for children aged 0-9 years presenting with a cough or upper respiratory tract infection. Recruited by Clinical Research Networks and Clinical Commissioning Groups.</p><p><strong>Intervention: </strong>Comprised: (1) elicitation of parental concerns during consultation; (2) a clinician-focused prognostic algorithm to identify children with acute cough and respiratory tract infection at low, average or elevated risk of hospitalisation in the next 30 days accompanied by prescribing guidance, (3) provision of a printout for carers including safety-netting advice.</p><p><strong>Main outcome measures: </strong>Co-primaries using the practice list-size for children aged 0-9 years as the denominator: rate of dispensed amoxicillin and macrolide items at each practice (superiority comparison) from <i>NHS Business Services Authority ePACT2</i> and rate of hospital admission for respiratory tract infection (non-inferiority comparison) from Clinical Commissioning Groups, both routinely collected over 12 months.</p><p><strong>Results: </strong>Of the 310 practices required, 294 (95%) were recruited (144 intervention and 150 controls) with 336,496 registered 0-9-year-olds (5% of all 0-9-year-old children in England) from 47 Clinical Commissioning Groups. Included practices were slightly larger than those not included, had slightly lower baseline dispensing rates and were located in more deprived areas (reflecting the distribution for practice postcodes nationally). Twelve practices (4%) subsequently withdrew (six related to the pandemic). The median number of times the intervention was used was 70 per practice (by a median of 9 clinicians) over 12 months. There was no evidence that the antibiotic dispensing rate in the intervention practices [0.155 (95% confidence interval 0.135 to 0.179)] differed to controls [0.154 (95% confid
{"title":"A multifaceted intervention to reduce antibiotic prescribing among CHIldren with acute COugh and respiratory tract infection: the CHICO cluster RCT.","authors":"Peter S Blair, Grace J Young, Clare Clement, Padraig Dixon, Penny Seume, Jenny Ingram, Jodi Taylor, Jeremy Horwood, Patricia J Lucas, Christie Cabral, Nick A Francis, Elizabeth Beech, Martin Gulliford, Sam Creavin, Janet A Lane, Scott Bevan, Alastair D Hay","doi":"10.3310/UCTH3411","DOIUrl":"10.3310/UCTH3411","url":null,"abstract":"<p><strong>Background: </strong>Clinical uncertainty in primary care regarding the prognosis of children with respiratory tract infections contributes to the unnecessary use of antibiotics. Improved identification of children at low risk of future hospitalisation might reduce clinical uncertainty. A National Institute for Health and Care Research-funded 5-year programme (RP-PG-0608-10018) was used to develop and feasibility test an intervention.</p><p><strong>Objectives: </strong>The aim of the children with acute cough randomised controlled trial was to reduce antibiotic prescribing among children presenting with acute cough and respiratory tract infection without increasing hospital admission.</p><p><strong>Design: </strong>An efficient, pragmatic open-label, two-arm trial (with embedded qualitative and health economic analyses) using practice-level randomisation using routinely collected data as the primary outcome.</p><p><strong>Setting: </strong>General practitioner practices in England.</p><p><strong>Participants: </strong>General practitioner practices using the Egton Medical Information Systems<sup>®</sup> patient-record system for children aged 0-9 years presenting with a cough or upper respiratory tract infection. Recruited by Clinical Research Networks and Clinical Commissioning Groups.</p><p><strong>Intervention: </strong>Comprised: (1) elicitation of parental concerns during consultation; (2) a clinician-focused prognostic algorithm to identify children with acute cough and respiratory tract infection at low, average or elevated risk of hospitalisation in the next 30 days accompanied by prescribing guidance, (3) provision of a printout for carers including safety-netting advice.</p><p><strong>Main outcome measures: </strong>Co-primaries using the practice list-size for children aged 0-9 years as the denominator: rate of dispensed amoxicillin and macrolide items at each practice (superiority comparison) from <i>NHS Business Services Authority ePACT2</i> and rate of hospital admission for respiratory tract infection (non-inferiority comparison) from Clinical Commissioning Groups, both routinely collected over 12 months.</p><p><strong>Results: </strong>Of the 310 practices required, 294 (95%) were recruited (144 intervention and 150 controls) with 336,496 registered 0-9-year-olds (5% of all 0-9-year-old children in England) from 47 Clinical Commissioning Groups. Included practices were slightly larger than those not included, had slightly lower baseline dispensing rates and were located in more deprived areas (reflecting the distribution for practice postcodes nationally). Twelve practices (4%) subsequently withdrew (six related to the pandemic). The median number of times the intervention was used was 70 per practice (by a median of 9 clinicians) over 12 months. There was no evidence that the antibiotic dispensing rate in the intervention practices [0.155 (95% confidence interval 0.135 to 0.179)] differed to controls [0.154 (95% confid","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"27 32","pages":"1-110"},"PeriodicalIF":3.5,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017154/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139416848","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}
Barnaby R Scholefield, Julie C Menzies, Jennifer McAnuff, Jacqueline Y Thompson, Joseph C Manning, Richard G Feltbower, Michelle Geary, Sophie Lockley, Kevin P Morris, David Moore, Nazima Pathan, Fenella Kirkham, Robert Forsyth, Tim Rapley
<p><strong>Background: </strong>Early rehabilitation and mobilisation encompass patient-tailored interventions, delivered within intensive care, but there are few studies in children and young people within paediatric intensive care units.</p><p><strong>Objectives: </strong>To explore how healthcare professionals currently practise early rehabilitation and mobilisation using qualitative and quantitative approaches; co-design the Paediatric Early Rehabilitation and Mobilisation during InTensive care manual of early rehabilitation and mobilisation interventions, with primary and secondary patient-centred outcomes; explore feasibility and acceptability of implementing the Paediatric Early Rehabilitation and Mobilisation during InTensive care manual within three paediatric intensive care units.</p><p><strong>Design: </strong>Mixed-methods feasibility with five interlinked studies (scoping review, survey, observational study, codesign workshops, feasibility study) in three phases.</p><p><strong>Setting: </strong>United Kingdom paediatric intensive care units.</p><p><strong>Participants: </strong>Children and young people aged 0-16 years remaining within paediatric intensive care on day 3, their parents/guardians and healthcare professionals.</p><p><strong>Interventions: </strong>In Phase 3, unit-wide implementation of manualised early rehabilitation and mobilisation.</p><p><strong>Main outcome measures: </strong>Phase 1 observational study: prevalence of any early rehabilitation and mobilisation on day 3. Phase 3 feasibility study: acceptability of early rehabilitation and mobilisation intervention; adverse events; acceptability of study design; acceptability of outcome measures.</p><p><strong>Data sources: </strong>Searched Excerpta Medica Database, Cumulative Index to Nursing and Allied Health Literature, MEDLINE, PEDro, Open grey and Cochrane CENTRAL databases.</p><p><strong>Review methods: </strong>Narrative synthesis.</p><p><strong>Results: </strong>In the scoping review we identified 36 full-text reports evaluating rehabilitation initiated within 7 days of paediatric intensive care unit admission, outlining non-mobility and mobility early rehabilitation and mobilisation interventions from 24 to 72 hours and delivered twice daily. With the survey, 124/191 (65%) responded from 26/29 (90%) United Kingdom paediatric intensive care units; the majority considered early rehabilitation and mobilisation a priority. The observational study followed 169 patients from 15 units; prevalence of any early rehabilitation and mobilisation on day 3 was 95.3%. We then developed a manualised early rehabilitation and mobilisation intervention informed by current evidence, experience and theory. All three sites implemented the Paediatric Early Rehabilitation and Mobilisation during InTensive care manual successfully, recruited to target (30 patients recruited) and followed up the patients until day 30 or discharge; 21/30 parents consented to complete additional outcom
{"title":"Implementing early rehabilitation and mobilisation for children in UK paediatric intensive care units: the PERMIT feasibility study.","authors":"Barnaby R Scholefield, Julie C Menzies, Jennifer McAnuff, Jacqueline Y Thompson, Joseph C Manning, Richard G Feltbower, Michelle Geary, Sophie Lockley, Kevin P Morris, David Moore, Nazima Pathan, Fenella Kirkham, Robert Forsyth, Tim Rapley","doi":"10.3310/HYRW5688","DOIUrl":"10.3310/HYRW5688","url":null,"abstract":"<p><strong>Background: </strong>Early rehabilitation and mobilisation encompass patient-tailored interventions, delivered within intensive care, but there are few studies in children and young people within paediatric intensive care units.</p><p><strong>Objectives: </strong>To explore how healthcare professionals currently practise early rehabilitation and mobilisation using qualitative and quantitative approaches; co-design the Paediatric Early Rehabilitation and Mobilisation during InTensive care manual of early rehabilitation and mobilisation interventions, with primary and secondary patient-centred outcomes; explore feasibility and acceptability of implementing the Paediatric Early Rehabilitation and Mobilisation during InTensive care manual within three paediatric intensive care units.</p><p><strong>Design: </strong>Mixed-methods feasibility with five interlinked studies (scoping review, survey, observational study, codesign workshops, feasibility study) in three phases.</p><p><strong>Setting: </strong>United Kingdom paediatric intensive care units.</p><p><strong>Participants: </strong>Children and young people aged 0-16 years remaining within paediatric intensive care on day 3, their parents/guardians and healthcare professionals.</p><p><strong>Interventions: </strong>In Phase 3, unit-wide implementation of manualised early rehabilitation and mobilisation.</p><p><strong>Main outcome measures: </strong>Phase 1 observational study: prevalence of any early rehabilitation and mobilisation on day 3. Phase 3 feasibility study: acceptability of early rehabilitation and mobilisation intervention; adverse events; acceptability of study design; acceptability of outcome measures.</p><p><strong>Data sources: </strong>Searched Excerpta Medica Database, Cumulative Index to Nursing and Allied Health Literature, MEDLINE, PEDro, Open grey and Cochrane CENTRAL databases.</p><p><strong>Review methods: </strong>Narrative synthesis.</p><p><strong>Results: </strong>In the scoping review we identified 36 full-text reports evaluating rehabilitation initiated within 7 days of paediatric intensive care unit admission, outlining non-mobility and mobility early rehabilitation and mobilisation interventions from 24 to 72 hours and delivered twice daily. With the survey, 124/191 (65%) responded from 26/29 (90%) United Kingdom paediatric intensive care units; the majority considered early rehabilitation and mobilisation a priority. The observational study followed 169 patients from 15 units; prevalence of any early rehabilitation and mobilisation on day 3 was 95.3%. We then developed a manualised early rehabilitation and mobilisation intervention informed by current evidence, experience and theory. All three sites implemented the Paediatric Early Rehabilitation and Mobilisation during InTensive care manual successfully, recruited to target (30 patients recruited) and followed up the patients until day 30 or discharge; 21/30 parents consented to complete additional outcom","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"27 27","pages":"1-155"},"PeriodicalIF":3.5,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017141/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138803022","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}
Adrian Murray Brunt, Joanne S Haviland, Duncan A Wheatley, Mark A Sydenham, David J Bloomfield, Charlie Chan, Suzy Cleator, Charlotte E Coles, Ellen Donovan, Helen Fleming, David Glynn, Andrew Goodman, Susan Griffin, Penelope Hopwood, Anna M Kirby, Cliona C Kirwan, Zohal Nabi, Jaymini Patel, Elinor Sawyer, Navita Somaiah, Isabel Syndikus, Karen Venables, John R Yarnold, Judith M Bliss
<p><strong>Background: </strong>FAST-Forward aimed to identify a 5-fraction schedule of adjuvant radiotherapy delivered in 1 week that was non-inferior in terms of local cancer control and as safe as the standard 15-fraction regimen after primary surgery for early breast cancer. Published acute toxicity and 5-year results are presented here with other aspects of the trial.</p><p><strong>Design: </strong>Multicentre phase III non-inferiority trial. Patients with invasive carcinoma of the breast (pT1-3pN0-1M0) after breast conservation surgery or mastectomy randomised (1 : 1 : 1) to 40 Gy in 15 fractions (3 weeks), 27 Gy or 26 Gy in 5 fractions (1 week) whole breast/chest wall (Main Trial). Primary endpoint was ipsilateral breast tumour relapse; assuming 2% 5-year incidence for 40 Gy, non-inferiority pre-defined as < 1.6% excess for 5-fraction schedules (critical hazard ratio = 1.81). Normal tissue effects were assessed independently by clinicians, patients and photographs.</p><p><strong>Sub-studies: </strong>Two acute skin toxicity sub-studies were undertaken to confirm safety of the test schedules. Primary endpoint was proportion of patients with grade ≥ 3 acute breast skin toxicity at any time from the start of radiotherapy to 4 weeks after completion. Nodal Sub-Study patients had breast/chest wall plus axillary radiotherapy testing the same three schedules, reduced to the 40 and 26 Gy groups on amendment, with the primary endpoint of 5-year patient-reported arm/hand swelling.</p><p><strong>Limitations: </strong>A sequential hypofractionated or simultaneous integrated boost has not been studied.</p><p><strong>Participants: </strong>Ninety-seven UK centres recruited 4096 patients (1361:40 Gy, 1367:27 Gy, 1368:26 Gy) into the Main Trial from November 2011 to June 2014. The Nodal Sub-Study recruited an additional 469 patients from 50 UK centres. One hundred and ninety and 162 Main Trial patients were included in the acute toxicity sub-studies.</p><p><strong>Results: </strong>Acute toxicity sub-studies evaluable patients: (1) acute grade 3 Radiation Therapy Oncology Group toxicity reported in 40 Gy/15 fractions 6/44 (13.6%); 27 Gy/5 fractions 5/51 (9.8%); 26 Gy/5 fractions 3/52 (5.8%). (2) Grade 3 common toxicity criteria for adverse effects toxicity reported for one patient. At 71-month median follow-up in the Main Trial, 79 ipsilateral breast tumour relapse events (40 Gy: 31, 27 Gy: 27, 26 Gy: 21); hazard ratios (95% confidence interval) versus 40 Gy were 27 Gy: 0.86 (0.51 to 1.44), 26 Gy: 0.67 (0.38 to 1.16). With 2.1% (1.4 to 3.1) 5-year incidence ipsilateral breast tumour relapse after 40 Gy, estimated absolute differences versus 40 Gy (non-inferiority test) were -0.3% (-1.0-0.9) for 27 Gy (<i>p</i> = 0.0022) and -0.7% (-1.3-0.3) for 26 Gy (<i>p</i> = 0.00019). Five-year prevalence of any clinician-assessed moderate/marked breast normal tissue effects was 40 Gy: 98/986 (9.9%), 27 Gy: 155/1005 (15.4%), 26 Gy: 121/1020 (11.9%). Across all clinici
{"title":"One versus three weeks hypofractionated whole breast radiotherapy for early breast cancer treatment: the FAST-Forward phase III RCT.","authors":"Adrian Murray Brunt, Joanne S Haviland, Duncan A Wheatley, Mark A Sydenham, David J Bloomfield, Charlie Chan, Suzy Cleator, Charlotte E Coles, Ellen Donovan, Helen Fleming, David Glynn, Andrew Goodman, Susan Griffin, Penelope Hopwood, Anna M Kirby, Cliona C Kirwan, Zohal Nabi, Jaymini Patel, Elinor Sawyer, Navita Somaiah, Isabel Syndikus, Karen Venables, John R Yarnold, Judith M Bliss","doi":"10.3310/WWBF1044","DOIUrl":"10.3310/WWBF1044","url":null,"abstract":"<p><strong>Background: </strong>FAST-Forward aimed to identify a 5-fraction schedule of adjuvant radiotherapy delivered in 1 week that was non-inferior in terms of local cancer control and as safe as the standard 15-fraction regimen after primary surgery for early breast cancer. Published acute toxicity and 5-year results are presented here with other aspects of the trial.</p><p><strong>Design: </strong>Multicentre phase III non-inferiority trial. Patients with invasive carcinoma of the breast (pT1-3pN0-1M0) after breast conservation surgery or mastectomy randomised (1 : 1 : 1) to 40 Gy in 15 fractions (3 weeks), 27 Gy or 26 Gy in 5 fractions (1 week) whole breast/chest wall (Main Trial). Primary endpoint was ipsilateral breast tumour relapse; assuming 2% 5-year incidence for 40 Gy, non-inferiority pre-defined as < 1.6% excess for 5-fraction schedules (critical hazard ratio = 1.81). Normal tissue effects were assessed independently by clinicians, patients and photographs.</p><p><strong>Sub-studies: </strong>Two acute skin toxicity sub-studies were undertaken to confirm safety of the test schedules. Primary endpoint was proportion of patients with grade ≥ 3 acute breast skin toxicity at any time from the start of radiotherapy to 4 weeks after completion. Nodal Sub-Study patients had breast/chest wall plus axillary radiotherapy testing the same three schedules, reduced to the 40 and 26 Gy groups on amendment, with the primary endpoint of 5-year patient-reported arm/hand swelling.</p><p><strong>Limitations: </strong>A sequential hypofractionated or simultaneous integrated boost has not been studied.</p><p><strong>Participants: </strong>Ninety-seven UK centres recruited 4096 patients (1361:40 Gy, 1367:27 Gy, 1368:26 Gy) into the Main Trial from November 2011 to June 2014. The Nodal Sub-Study recruited an additional 469 patients from 50 UK centres. One hundred and ninety and 162 Main Trial patients were included in the acute toxicity sub-studies.</p><p><strong>Results: </strong>Acute toxicity sub-studies evaluable patients: (1) acute grade 3 Radiation Therapy Oncology Group toxicity reported in 40 Gy/15 fractions 6/44 (13.6%); 27 Gy/5 fractions 5/51 (9.8%); 26 Gy/5 fractions 3/52 (5.8%). (2) Grade 3 common toxicity criteria for adverse effects toxicity reported for one patient. At 71-month median follow-up in the Main Trial, 79 ipsilateral breast tumour relapse events (40 Gy: 31, 27 Gy: 27, 26 Gy: 21); hazard ratios (95% confidence interval) versus 40 Gy were 27 Gy: 0.86 (0.51 to 1.44), 26 Gy: 0.67 (0.38 to 1.16). With 2.1% (1.4 to 3.1) 5-year incidence ipsilateral breast tumour relapse after 40 Gy, estimated absolute differences versus 40 Gy (non-inferiority test) were -0.3% (-1.0-0.9) for 27 Gy (<i>p</i> = 0.0022) and -0.7% (-1.3-0.3) for 26 Gy (<i>p</i> = 0.00019). Five-year prevalence of any clinician-assessed moderate/marked breast normal tissue effects was 40 Gy: 98/986 (9.9%), 27 Gy: 155/1005 (15.4%), 26 Gy: 121/1020 (11.9%). Across all clinici","PeriodicalId":12898,"journal":{"name":"Health technology assessment","volume":"27 25","pages":"1-176"},"PeriodicalIF":3.5,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11017153/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138290804","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}
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