Kay Wang, Sharon Tonner, Malcolm G Semple, Jane Wolstenholme, Rafael Perera, Anthony Harnden
Background Influenza and influenza-like illness place significant burden on the NHS. Children with underlying health conditions are vulnerable to developing bacterial complications. Objective To strengthen the evidence base underlying antibiotic use in at-risk children with influenza-like illness. Design This programme comprised five separate work packages. Work package A investigated published and unpublished data from previously published literature and work package B explored attitudes of parents and general practitioners to influenza-like illness and antibiotics in at-risk children. This was followed by a clinical trial to assess the effectiveness of early co-amoxiclav (Augmentin ® , GlaxoSmithKline UK) use at reducing reconsultation due to clinical deterioration (work package C), a nested sub-study to examine bacterial carriage indicators of antibiotic resistance (work package D) and a within-trial economic evaluation and clinical risk prediction analysis (work package E). Setting Interviews were conducted by telephone with general practitioners across the UK and parents/guardians in England (work package B). We conducted the clinical trial (work package C and nested work packages D and E) in general practices and ambulatory care services in England and Wales. Participants General practitioners and parents/guardians of at-risk children who previously had influenza-like illness participated in work package B. At-risk children with influenza-like illness aged 6 months to 12 years participated in work packages C and E and optionally in work package D. Interventions The intervention for the clinical trial was a 5-day course of co-amoxiclav 400/57 with dosing regimens based on British National Formulary guidance. Main outcome measures Hospital admission (work package A); findings from semi-structured interviews with patients and health-care professionals (work package B); proportion of patients who reconsulted owing to clinical deterioration (work package C); respiratory bacterial carriage and antibiotic resistance of potentially pathogenic respiratory tract bacteria at 3, 6, 9 and 12 months (work package D); and risk factors for reconsultation owing to clinical deterioration, quality of life (EuroQol-5 Dimensions, three-level youth version), symptoms (Canadian Acute Respiratory Infection and Flu Scale), health-care use and costs (work package E). Review methods For work package A, we searched the MEDLINE, MEDLINE In-Process, EMBASE, Science Citation Index and CINAHL (Cumulative Index to Nursing and Allied Health Literature) databases until 3 April 2013 with no language restrictions and requested unpublished data from authors of studies which had collected but not published relevant data. We included studies involving children up to 18 years of age with influenza or influenza-like illness from primary or ambulatory care settings. We used univariable meta-analysis methods to calculate odds ratios with 95% confidence intervals for individual risk f
{"title":"The early use of Antibiotics for At-risk children with InfluEnza in Primary Care (the ARCHIE programme)","authors":"Kay Wang, Sharon Tonner, Malcolm G Semple, Jane Wolstenholme, Rafael Perera, Anthony Harnden","doi":"10.3310/wdfr7331","DOIUrl":"https://doi.org/10.3310/wdfr7331","url":null,"abstract":"Background Influenza and influenza-like illness place significant burden on the NHS. Children with underlying health conditions are vulnerable to developing bacterial complications. Objective To strengthen the evidence base underlying antibiotic use in at-risk children with influenza-like illness. Design This programme comprised five separate work packages. Work package A investigated published and unpublished data from previously published literature and work package B explored attitudes of parents and general practitioners to influenza-like illness and antibiotics in at-risk children. This was followed by a clinical trial to assess the effectiveness of early co-amoxiclav (Augmentin ® , GlaxoSmithKline UK) use at reducing reconsultation due to clinical deterioration (work package C), a nested sub-study to examine bacterial carriage indicators of antibiotic resistance (work package D) and a within-trial economic evaluation and clinical risk prediction analysis (work package E). Setting Interviews were conducted by telephone with general practitioners across the UK and parents/guardians in England (work package B). We conducted the clinical trial (work package C and nested work packages D and E) in general practices and ambulatory care services in England and Wales. Participants General practitioners and parents/guardians of at-risk children who previously had influenza-like illness participated in work package B. At-risk children with influenza-like illness aged 6 months to 12 years participated in work packages C and E and optionally in work package D. Interventions The intervention for the clinical trial was a 5-day course of co-amoxiclav 400/57 with dosing regimens based on British National Formulary guidance. Main outcome measures Hospital admission (work package A); findings from semi-structured interviews with patients and health-care professionals (work package B); proportion of patients who reconsulted owing to clinical deterioration (work package C); respiratory bacterial carriage and antibiotic resistance of potentially pathogenic respiratory tract bacteria at 3, 6, 9 and 12 months (work package D); and risk factors for reconsultation owing to clinical deterioration, quality of life (EuroQol-5 Dimensions, three-level youth version), symptoms (Canadian Acute Respiratory Infection and Flu Scale), health-care use and costs (work package E). Review methods For work package A, we searched the MEDLINE, MEDLINE In-Process, EMBASE, Science Citation Index and CINAHL (Cumulative Index to Nursing and Allied Health Literature) databases until 3 April 2013 with no language restrictions and requested unpublished data from authors of studies which had collected but not published relevant data. We included studies involving children up to 18 years of age with influenza or influenza-like illness from primary or ambulatory care settings. We used univariable meta-analysis methods to calculate odds ratios with 95% confidence intervals for individual risk f","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135422256","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
L. Yardley, Katherine Morton, K. Greenwell, B. Stuart, C. Rice, K. Bradbury, B. Ainsworth, R. Band, E. Murray, F. Mair, C. May, S. Michie, Samantha Richards-Hall, Peter Smith, A. Bruton, J. Raftery, Shihua Zhu, M. Thomas, R. McManus, P. Little
Digital interventions offer a potentially cost-effective means to support patient self-management in primary care, but evidence for the feasibility, acceptability and cost-effectiveness of digital interventions remains mixed. This programme focused on the potential for self-management digital interventions to improve outcomes in two common, contrasting conditions (i.e. hypertension and asthma) for which care is currently suboptimal, leading to excess deaths, illness, disability and costs for the NHS. The overall purpose was to address the question of how digital interventions can best provide cost-effective support for patient self-management in primary care. Our aims were to develop and trial digital interventions to support patient self-management of hypertension and asthma. Through the process of planning, developing and evaluating these interventions, we also aimed to generate a better understanding of what features and methods for implementing digital interventions could make digital interventions acceptable, feasible, effective and cost-effective to integrate into primary care. For the hypertension strand, we carried out systematic reviews of quantitative and qualitative evidence, intervention planning, development and optimisation, and an unmasked randomised controlled trial comparing digital intervention with usual care, with a health economic analysis and nested process evaluation. For the asthma strand, we carried out a systematic review of quantitative evidence, intervention planning, development and optimisation, and a feasibility randomised controlled trial comparing digital intervention with usual care, with nested process evaluation. General practices (hypertension, n = 76; asthma, n = 7) across Wessex and Thames Valley regions in Southern England. For the hypertension strand, people with uncontrolled hypertension taking one, two or three antihypertensive medications. For the asthma strand, adults with asthma and impaired asthma-related quality of life. Our hypertension intervention (i.e. HOME BP) was a digital intervention that included motivational training for patients to self-monitor blood pressure, as well as health-care professionals to support self-management; a digital interface to send monthly readings to the health-care professional and to prompt planned medication changes when patients’ readings exceeded recommended targets for 2 consecutive months; and support for optional patient healthy behaviour change (e.g. healthy diet/weight loss, increased physical activity and reduced alcohol and salt consumption). The control group were provided with a Blood Pressure UK (London, UK) leaflet for hypertension and received routine hypertension care. Our asthma intervention (i.e. My Breathing Matters) was a digital intervention to improve the functional quality of life of primary care patients with asthma by supporting illness self-management. Motivational content intended to facilitate use of
{"title":"Digital interventions for hypertension and asthma to support patient self-management in primary care: the DIPSS research programme including two RCTs","authors":"L. Yardley, Katherine Morton, K. Greenwell, B. Stuart, C. Rice, K. Bradbury, B. Ainsworth, R. Band, E. Murray, F. Mair, C. May, S. Michie, Samantha Richards-Hall, Peter Smith, A. Bruton, J. Raftery, Shihua Zhu, M. Thomas, R. McManus, P. Little","doi":"10.3310/bwfi7321","DOIUrl":"https://doi.org/10.3310/bwfi7321","url":null,"abstract":"\u0000 \u0000 Digital interventions offer a potentially cost-effective means to support patient self-management in primary care, but evidence for the feasibility, acceptability and cost-effectiveness of digital interventions remains mixed. This programme focused on the potential for self-management digital interventions to improve outcomes in two common, contrasting conditions (i.e. hypertension and asthma) for which care is currently suboptimal, leading to excess deaths, illness, disability and costs for the NHS.\u0000 \u0000 \u0000 \u0000 The overall purpose was to address the question of how digital interventions can best provide cost-effective support for patient self-management in primary care. Our aims were to develop and trial digital interventions to support patient self-management of hypertension and asthma. Through the process of planning, developing and evaluating these interventions, we also aimed to generate a better understanding of what features and methods for implementing digital interventions could make digital interventions acceptable, feasible, effective and cost-effective to integrate into primary care.\u0000 \u0000 \u0000 \u0000 For the hypertension strand, we carried out systematic reviews of quantitative and qualitative evidence, intervention planning, development and optimisation, and an unmasked randomised controlled trial comparing digital intervention with usual care, with a health economic analysis and nested process evaluation. For the asthma strand, we carried out a systematic review of quantitative evidence, intervention planning, development and optimisation, and a feasibility randomised controlled trial comparing digital intervention with usual care, with nested process evaluation.\u0000 \u0000 \u0000 \u0000 General practices (hypertension, n = 76; asthma, n = 7) across Wessex and Thames Valley regions in Southern England.\u0000 \u0000 \u0000 \u0000 For the hypertension strand, people with uncontrolled hypertension taking one, two or three antihypertensive medications. For the asthma strand, adults with asthma and impaired asthma-related quality of life.\u0000 \u0000 \u0000 \u0000 Our hypertension intervention (i.e. HOME BP) was a digital intervention that included motivational training for patients to self-monitor blood pressure, as well as health-care professionals to support self-management; a digital interface to send monthly readings to the health-care professional and to prompt planned medication changes when patients’ readings exceeded recommended targets for 2 consecutive months; and support for optional patient healthy behaviour change (e.g. healthy diet/weight loss, increased physical activity and reduced alcohol and salt consumption). The control group were provided with a Blood Pressure UK (London, UK) leaflet for hypertension and received routine hypertension care. Our asthma intervention (i.e. My Breathing Matters) was a digital intervention to improve the functional quality of life of primary care patients with asthma by supporting illness self-management. Motivational content intended to facilitate use of","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76094980","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A. Blom, A. Beswick, A. Burston, F. Carroll, K. Garfield, R. Gooberman-Hill, Shaun Harris, S. Kunutsor, A. Lane, E. Lenguerrand, A. MacGowan, C. Mallon, Andrew J. Moore, S. Noble, Cecily K Palmer, O. Rolfson, S. Strange, M. Whitehouse
People with severe osteoarthritis, other joint conditions or injury may have joint replacement to reduce pain and disability. In the UK in 2019, over 200,000 hip and knee replacements were performed. About 1 in 100 replacements becomes infected, and most people with infected replacements require further surgery. To investigate why some patients are predisposed to joint infections and how this affects patients and the NHS, and to evaluate treatments. Systematic reviews, joint registry analyses, qualitative interviews, a randomised controlled trial, health economic analyses and a discrete choice questionnaire. Our studies are relevant to the NHS, to the Swedish health system and internationally. People with prosthetic joint infection after hip or knee replacement and surgeons. Revision of hip prosthetic joint infection with a single- or two-stage procedure. Long-term patient-reported outcomes and reinfection. Cost-effectiveness of revision strategies over 18 months from two perspectives: health-care provider and Personal Social Services, and societal. National Joint Registry; literature databases; published cohort studies; interviews with 67 patients and 35 surgeons; a patient discrete choice questionnaire; and the INFORM (INFection ORthopaedic Management) randomised trial. Systematic reviews of studies reporting risk factors, diagnosis, treatment outcomes and cost comparisons. Individual patient data meta-analysis. In registry analyses, about 0.62% and 0.75% of patients with hip and knee replacement, respectively, had joint infection requiring surgery. Rates were four times greater after aseptic revision. The costs of inpatient and day-case admissions in people with hip prosthetic joint infection were about five times higher than those in people with no infection, an additional cost of > £30,000. People described devastating effects of hip and knee prosthetic joint infection and treatment. In the treatment of hip prosthetic joint infection, a two-stage procedure with or without a cement spacer had a greater negative impact on patient well-being than a single- or two-stage procedure with a custom-made articulating spacer. Surgeons described the significant emotional impact of hip and knee prosthetic joint infection and the importance of a supportive multidisciplinary team. In systematic reviews and registry analyses, the risk factors for hip and knee prosthetic joint infection included male sex, diagnoses other than osteoarthritis, high body mass index, poor physical status, diabetes, dementia and liver disease. Evidence linking health-care setting and surgeon experience with prosthetic joint infection was inconsistent. Uncemented fixation, posterior approach and ceramic bearings were associated with lower infection risk after hip replacement. In our systematic review, synovial fluid alpha-defensin and leucocyte esterase showed high diagnostic accuracy for prosthetic joint infection
{"title":"Infection after total joint replacement of the hip and knee: research programme including the INFORM RCT","authors":"A. Blom, A. Beswick, A. Burston, F. Carroll, K. Garfield, R. Gooberman-Hill, Shaun Harris, S. Kunutsor, A. Lane, E. Lenguerrand, A. MacGowan, C. Mallon, Andrew J. Moore, S. Noble, Cecily K Palmer, O. Rolfson, S. Strange, M. Whitehouse","doi":"10.3310/hdwl9760","DOIUrl":"https://doi.org/10.3310/hdwl9760","url":null,"abstract":"\u0000 \u0000 People with severe osteoarthritis, other joint conditions or injury may have joint replacement to reduce pain and disability. In the UK in 2019, over 200,000 hip and knee replacements were performed. About 1 in 100 replacements becomes infected, and most people with infected replacements require further surgery.\u0000 \u0000 \u0000 \u0000 To investigate why some patients are predisposed to joint infections and how this affects patients and the NHS, and to evaluate treatments.\u0000 \u0000 \u0000 \u0000 Systematic reviews, joint registry analyses, qualitative interviews, a randomised controlled trial, health economic analyses and a discrete choice questionnaire.\u0000 \u0000 \u0000 \u0000 Our studies are relevant to the NHS, to the Swedish health system and internationally.\u0000 \u0000 \u0000 \u0000 People with prosthetic joint infection after hip or knee replacement and surgeons.\u0000 \u0000 \u0000 \u0000 Revision of hip prosthetic joint infection with a single- or two-stage procedure.\u0000 \u0000 \u0000 \u0000 Long-term patient-reported outcomes and reinfection. Cost-effectiveness of revision strategies over 18 months from two perspectives: health-care provider and Personal Social Services, and societal.\u0000 \u0000 \u0000 \u0000 National Joint Registry; literature databases; published cohort studies; interviews with 67 patients and 35 surgeons; a patient discrete choice questionnaire; and the INFORM (INFection ORthopaedic Management) randomised trial.\u0000 \u0000 \u0000 \u0000 Systematic reviews of studies reporting risk factors, diagnosis, treatment outcomes and cost comparisons. Individual patient data meta-analysis.\u0000 \u0000 \u0000 \u0000 In registry analyses, about 0.62% and 0.75% of patients with hip and knee replacement, respectively, had joint infection requiring surgery. Rates were four times greater after aseptic revision. The costs of inpatient and day-case admissions in people with hip prosthetic joint infection were about five times higher than those in people with no infection, an additional cost of > £30,000. People described devastating effects of hip and knee prosthetic joint infection and treatment. In the treatment of hip prosthetic joint infection, a two-stage procedure with or without a cement spacer had a greater negative impact on patient well-being than a single- or two-stage procedure with a custom-made articulating spacer. Surgeons described the significant emotional impact of hip and knee prosthetic joint infection and the importance of a supportive multidisciplinary team. In systematic reviews and registry analyses, the risk factors for hip and knee prosthetic joint infection included male sex, diagnoses other than osteoarthritis, high body mass index, poor physical status, diabetes, dementia and liver disease. Evidence linking health-care setting and surgeon experience with prosthetic joint infection was inconsistent. Uncemented fixation, posterior approach and ceramic bearings were associated with lower infection risk after hip replacement. In our systematic review, synovial fluid alpha-defensin and leucocyte esterase showed high diagnostic accuracy for prosthetic joint infection","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87861482","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
R. Byng, C. Lennox, Tim Kirkpatrick, C. Quinn, Robert F. Anderson, S. Brand, Lynne Callaghan, L. Carroll, G. Durcan, Laura Gill, Sara Goodier, Jonathan Graham, Rebecca Greer, Mark Haddad, T. Harris, W. Henley, R. Hunter, M. Maguire, S. Leonard, S. Michie, C. Owens, M. Pearson, Sarah Rybczynska-Bunt, C. Stevenson, Amy Stewart, A. Stirzaker, Rodney S Taylor, R. Todd, F. Walter, F. Warren, Lauren Weston, N. Wright, J. Shaw
Many male prison leavers have significant mental health problems. Prison leavers often have a history of trauma, ongoing substance misuse and housing insecurity. Only a minority of prison leavers receive mental health care on release from prison. The aim of the Engager research programme was to develop and evaluate a theory- and evidence-informed complex intervention designed to support individuals with common mental health problems (e.g. anxiety, depression) and other complex needs, including mental health comorbidity, before and after release from prison. In phase 1, the intervention was developed through a set of realist-informed substudies, including a realist review of psychosocial care for individuals with complex needs, case studies within services demonstrating promising intervention features, focus groups with individuals from under-represented groups, a rapid realist review of the intervention implementation literature and a formative process evaluation of the prototype intervention. In a parallel randomised trial, methodological development included selecting outcome measures through reviewing literature, piloting measures and a consensus process, developing ways to quantify intervention receipt, piloting trial procedures and modelling economic outcomes. In phase 2, we conducted an individually randomised superiority trial of the Engager intervention, cost-effectiveness and cost–consequence analyses and an in-depth mixed-methods process evaluation. Patient and public involvement influenced the programme throughout, primarily through a Peer Researcher Group. In phase 1, the Engager intervention included multiple components. A practitioner offered participants practical support, emotional help (including mentalisation-based approaches) and liaison with other services in prison on the day of the participant’s release and for 3–5 months post release. An intervention delivery platform (i.e. training, manual, supervision) supported implementation. Outcome measures were selected through testing and stakeholder consensus to represent a broad range of domains, with a general mental health outcome as the primary measure for the trial. Procedures for recruitment and follow-up were tested and included flexible approaches to engagement and retention. In phase 2, the trial was conducted in three prison settings, with 280 participants randomised in a 1 : 1 ratio to receive either Engager plus usual care (n = 140) or usual care only (n = 140). We achieved a follow-up rate of 65% at 6 months post release from prison. We found no difference between the two groups for the Clinical Outcomes in Routine Evaluation – Outcome Measure at 6 months. No differences in secondary measures and sensitivity analyses were found beyond those expected by chance. The cost-effectiveness analysis showed that Engager cost significantly more at £2133 (95% of iterations between £997 and £3374) with no difference in quality-adjusted life-years (–0.017,
{"title":"Development and evaluation of a collaborative care intervention for male prison leavers with mental health problems: the Engager research programme","authors":"R. Byng, C. Lennox, Tim Kirkpatrick, C. Quinn, Robert F. Anderson, S. Brand, Lynne Callaghan, L. Carroll, G. Durcan, Laura Gill, Sara Goodier, Jonathan Graham, Rebecca Greer, Mark Haddad, T. Harris, W. Henley, R. Hunter, M. Maguire, S. Leonard, S. Michie, C. Owens, M. Pearson, Sarah Rybczynska-Bunt, C. Stevenson, Amy Stewart, A. Stirzaker, Rodney S Taylor, R. Todd, F. Walter, F. Warren, Lauren Weston, N. Wright, J. Shaw","doi":"10.3310/mmwc3761","DOIUrl":"https://doi.org/10.3310/mmwc3761","url":null,"abstract":"\u0000 \u0000 Many male prison leavers have significant mental health problems. Prison leavers often have a history of trauma, ongoing substance misuse and housing insecurity. Only a minority of prison leavers receive mental health care on release from prison.\u0000 \u0000 \u0000 \u0000 The aim of the Engager research programme was to develop and evaluate a theory- and evidence-informed complex intervention designed to support individuals with common mental health problems (e.g. anxiety, depression) and other complex needs, including mental health comorbidity, before and after release from prison.\u0000 \u0000 \u0000 \u0000 In phase 1, the intervention was developed through a set of realist-informed substudies, including a realist review of psychosocial care for individuals with complex needs, case studies within services demonstrating promising intervention features, focus groups with individuals from under-represented groups, a rapid realist review of the intervention implementation literature and a formative process evaluation of the prototype intervention. In a parallel randomised trial, methodological development included selecting outcome measures through reviewing literature, piloting measures and a consensus process, developing ways to quantify intervention receipt, piloting trial procedures and modelling economic outcomes. In phase 2, we conducted an individually randomised superiority trial of the Engager intervention, cost-effectiveness and cost–consequence analyses and an in-depth mixed-methods process evaluation. Patient and public involvement influenced the programme throughout, primarily through a Peer Researcher Group.\u0000 \u0000 \u0000 \u0000 In phase 1, the Engager intervention included multiple components. A practitioner offered participants practical support, emotional help (including mentalisation-based approaches) and liaison with other services in prison on the day of the participant’s release and for 3–5 months post release. An intervention delivery platform (i.e. training, manual, supervision) supported implementation. Outcome measures were selected through testing and stakeholder consensus to represent a broad range of domains, with a general mental health outcome as the primary measure for the trial. Procedures for recruitment and follow-up were tested and included flexible approaches to engagement and retention. In phase 2, the trial was conducted in three prison settings, with 280 participants randomised in a 1 : 1 ratio to receive either Engager plus usual care (n = 140) or usual care only (n = 140). We achieved a follow-up rate of 65% at 6 months post release from prison. We found no difference between the two groups for the Clinical Outcomes in Routine Evaluation – Outcome Measure at 6 months. No differences in secondary measures and sensitivity analyses were found beyond those expected by chance. The cost-effectiveness analysis showed that Engager cost significantly more at £2133 (95% of iterations between £997 and £3374) with no difference in quality-adjusted life-years (–0.017, ","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86952200","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
J. Sparrow, M. Grzeda, Andrew Frost, Christopher Liu, R. Johnston, P. Scanlon, Christalla Pithara, D. Elliott, J. Donovan, Natalie Joseph-Williams, Daniella Holland-Hart, P. Donachie, Padraig Dixon, R. Kandiyali, H. Taylor, K. Breheny, J. Sterne, W. Hollingworth, David Evans, Fiona Fox, Sofia Theodoropoulou, R. Hughes, Matthew Quinn, D. Gray, L. Benjamin, A. Loose, Lara Edwards, P. Craggs, Frances Paget, K. Kapoor, J. Searle
Surgery for established cataract is highly cost-effective and uncontroversial, yet uncertainty remains for individuals about when to proceed and when to delay surgery during the earlier stages of cataract. We aimed to improve decision-making for cataract surgery through the development of evidence-based clinical tools that provide general information and personalised risk/benefit information. We used a mixed methodology consisting of four work packages. Work package 1 involved the development and psychometric validation of a brief, patient self-reported measure of visual difficulty from cataract and its relief from surgery, named Cataract Patient-Reported Outcome Measure, five items (Cat-PROM5). Work package 2 involved the review and refinement of risk models for adverse surgical events (posterior capsule rupture and visual acuity loss related to cataract surgery). Work package 3 involved the development of prediction models for the Cat-PROM5-based self-reported outcomes from a cohort study of 1500 patients; assessment of the validity of preference-based health economic indices for cataract surgery and the calibration of these to Cat-PROM5; assessment of patients’ and health-care professionals’ views on risk–benefit presentation formats, the perceived usefulness of Cat-PROM5, the value of personalised risk–benefit information, high-value information items and shared decision-making; development of cataract decision aid frequently asked questions, incorporation of personalised estimates of risks and benefits; and development of a cataract decision quality measure to assess the quality of decision-making. Work package 4 involved a mixed-methods feasibility study for a fully powered randomised controlled trial of the use of the cataract decision aid and a qualitative study of discordant or mismatching perceptions of outcome between patients and health-care professionals. Four English NHS recruitment centres were involved: Bristol (lead centre), Brighton, Gloucestershire and Torbay. Multicentre NHS cataract surgery data were obtained from the National Ophthalmology Database. Work package 1 – participants (n = 822) were from all four centres. Work package 2 – electronic medical record data were taken from the National Ophthalmology Database (final set > 1M operations). Work package 3 – cohort study participants were from Bristol (n = 1200) and Gloucestershire (n = 300); qualitative and development work was undertaken with patients and health-care professionals from all four centres. Work package 4 – Bristol, Brighton and Torbay participated in the recruitment of patients (n = 42) for the feasibility trial and recruitment of health-care professionals for the qualitative elements. For the feasibility trial, the intervention was the use of the cataract decision aid, incorporating frequently asked questions and personalised estimations of both adverse outcomes and self-reported benefit. There was a range of qu
{"title":"Developing decision support tools incorporating personalised predictions of likely visual benefit versus harm for cataract surgery: research programme","authors":"J. Sparrow, M. Grzeda, Andrew Frost, Christopher Liu, R. Johnston, P. Scanlon, Christalla Pithara, D. Elliott, J. Donovan, Natalie Joseph-Williams, Daniella Holland-Hart, P. Donachie, Padraig Dixon, R. Kandiyali, H. Taylor, K. Breheny, J. Sterne, W. Hollingworth, David Evans, Fiona Fox, Sofia Theodoropoulou, R. Hughes, Matthew Quinn, D. Gray, L. Benjamin, A. Loose, Lara Edwards, P. Craggs, Frances Paget, K. Kapoor, J. Searle","doi":"10.3310/baga4188","DOIUrl":"https://doi.org/10.3310/baga4188","url":null,"abstract":"\u0000 \u0000 Surgery for established cataract is highly cost-effective and uncontroversial, yet uncertainty remains for individuals about when to proceed and when to delay surgery during the earlier stages of cataract.\u0000 \u0000 \u0000 \u0000 We aimed to improve decision-making for cataract surgery through the development of evidence-based clinical tools that provide general information and personalised risk/benefit information.\u0000 \u0000 \u0000 \u0000 We used a mixed methodology consisting of four work packages. Work package 1 involved the development and psychometric validation of a brief, patient self-reported measure of visual difficulty from cataract and its relief from surgery, named Cataract Patient-Reported Outcome Measure, five items (Cat-PROM5). Work package 2 involved the review and refinement of risk models for adverse surgical events (posterior capsule rupture and visual acuity loss related to cataract surgery). Work package 3 involved the development of prediction models for the Cat-PROM5-based self-reported outcomes from a cohort study of 1500 patients; assessment of the validity of preference-based health economic indices for cataract surgery and the calibration of these to Cat-PROM5; assessment of patients’ and health-care professionals’ views on risk–benefit presentation formats, the perceived usefulness of Cat-PROM5, the value of personalised risk–benefit information, high-value information items and shared decision-making; development of cataract decision aid frequently asked questions, incorporation of personalised estimates of risks and benefits; and development of a cataract decision quality measure to assess the quality of decision-making. Work package 4 involved a mixed-methods feasibility study for a fully powered randomised controlled trial of the use of the cataract decision aid and a qualitative study of discordant or mismatching perceptions of outcome between patients and health-care professionals.\u0000 \u0000 \u0000 \u0000 Four English NHS recruitment centres were involved: Bristol (lead centre), Brighton, Gloucestershire and Torbay. Multicentre NHS cataract surgery data were obtained from the National Ophthalmology Database.\u0000 \u0000 \u0000 \u0000 Work package 1 – participants (n = 822) were from all four centres. Work package 2 – electronic medical record data were taken from the National Ophthalmology Database (final set > 1M operations). Work package 3 – cohort study participants were from Bristol (n = 1200) and Gloucestershire (n = 300); qualitative and development work was undertaken with patients and health-care professionals from all four centres. Work package 4 – Bristol, Brighton and Torbay participated in the recruitment of patients (n = 42) for the feasibility trial and recruitment of health-care professionals for the qualitative elements.\u0000 \u0000 \u0000 \u0000 For the feasibility trial, the intervention was the use of the cataract decision aid, incorporating frequently asked questions and personalised estimations of both adverse outcomes and self-reported benefit.\u0000 \u0000 \u0000 \u0000 There was a range of qu","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79845398","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Aziz Sheikh, J. Coleman, Antony Chuter, Robin Williams, R. Lilford, A. Slee, Z. Morrison, K. Cresswell, Ann Robertson, S. Slight, H. Mozaffar, Lisa Lee, Sonal Shah, S. Pontefract, Abby King, V. Wiegel, S. Watson, Ndeshi Salema, David Bates, A. Avery, A. Girling, L. McCloughan, N. Watson
There is a need to identify approaches to reduce medication errors. Interest has converged on ePrescribing systems that incorporate computerised provider order entry and clinical decision support functionality. We sought to describe the procurement, implementation and adoption of basic and advanced ePrescribing systems; to estimate their effectiveness and cost-effectiveness; and to develop a toolkit for system integration into hospitals incorporating implications for practice from our research. We undertook a theoretically informed, mixed-methods, context-rich, naturalistic evaluation. We undertook six longitudinal case studies in four hospitals (sites C, E, J and K) that did not have ePrescribing systems at the start of the programme (three of which went live and one that never went live) and two hospitals (sites A and D) with embedded systems. In the three hospitals that implemented systems, we conducted interviews pre implementation, shortly after roll-out and at 1 year post implementation. In the hospitals that had embedded systems, we conducted two rounds of interviews, 18 months apart. We undertook a three-round eDelphi exercise involving 20 experts to identify 80 clinically important prescribing errors, which were developed into the Investigate Medication Prescribing Accuracy for Critical error Types (IMPACT) tool. We elicited the cost of an ePrescribing system at one (non-study) site and compared this with the calculated ‘headroom’ (the upper limit that the decision-maker should pay) for the systems (sites J, K and S) for which effectiveness estimates were available. We organised four national conferences and five expert round-table discussions to contextualise and disseminate our findings. The implementation of ePrescribing systems with either computerised provider order entry or clinical decision support functionality. Error rates were calculated using the IMPACT tool, with changes over time represented as ratios of error rates (as a proportion of opportunities for errors) using Poisson regression analyses. We conducted 242 interviews and 32.5 hours of observations and collected 55 documents across six case studies. Implementation was difficult, particularly in relation to integration and interfacing between systems. Much of the clinical decision support functionality in embedded sites remained switched off because of concerns about over alerting. Getting systems operational meant that little attention was devoted to system optimisation or secondary uses of data. The prescriptions of 1244 patients were audited pre computerised provider order entry and 1178 post computerised provider order entry implementation of system A at sites J and K, and system B at site S. A total of 21,138 opportunities for error were identified from 28,526 prescriptions. Across the three sites, for those prescriptions for which opportunities for error were identified, the error rate was found to reduce significantly
{"title":"Electronic prescribing systems in hospitals to improve medication safety: a multimethods research programme","authors":"Aziz Sheikh, J. Coleman, Antony Chuter, Robin Williams, R. Lilford, A. Slee, Z. Morrison, K. Cresswell, Ann Robertson, S. Slight, H. Mozaffar, Lisa Lee, Sonal Shah, S. Pontefract, Abby King, V. Wiegel, S. Watson, Ndeshi Salema, David Bates, A. Avery, A. Girling, L. McCloughan, N. Watson","doi":"10.3310/ksrs2009","DOIUrl":"https://doi.org/10.3310/ksrs2009","url":null,"abstract":"\u0000 \u0000 There is a need to identify approaches to reduce medication errors. Interest has converged on ePrescribing systems that incorporate computerised provider order entry and clinical decision support functionality.\u0000 \u0000 \u0000 \u0000 We sought to describe the procurement, implementation and adoption of basic and advanced ePrescribing systems; to estimate their effectiveness and cost-effectiveness; and to develop a toolkit for system integration into hospitals incorporating implications for practice from our research.\u0000 \u0000 \u0000 \u0000 We undertook a theoretically informed, mixed-methods, context-rich, naturalistic evaluation.\u0000 \u0000 \u0000 \u0000 We undertook six longitudinal case studies in four hospitals (sites C, E, J and K) that did not have ePrescribing systems at the start of the programme (three of which went live and one that never went live) and two hospitals (sites A and D) with embedded systems. In the three hospitals that implemented systems, we conducted interviews pre implementation, shortly after roll-out and at 1 year post implementation. In the hospitals that had embedded systems, we conducted two rounds of interviews, 18 months apart. We undertook a three-round eDelphi exercise involving 20 experts to identify 80 clinically important prescribing errors, which were developed into the Investigate Medication Prescribing Accuracy for Critical error Types (IMPACT) tool. We elicited the cost of an ePrescribing system at one (non-study) site and compared this with the calculated ‘headroom’ (the upper limit that the decision-maker should pay) for the systems (sites J, K and S) for which effectiveness estimates were available. We organised four national conferences and five expert round-table discussions to contextualise and disseminate our findings.\u0000 \u0000 \u0000 \u0000 The implementation of ePrescribing systems with either computerised provider order entry or clinical decision support functionality.\u0000 \u0000 \u0000 \u0000 Error rates were calculated using the IMPACT tool, with changes over time represented as ratios of error rates (as a proportion of opportunities for errors) using Poisson regression analyses.\u0000 \u0000 \u0000 \u0000 We conducted 242 interviews and 32.5 hours of observations and collected 55 documents across six case studies. Implementation was difficult, particularly in relation to integration and interfacing between systems. Much of the clinical decision support functionality in embedded sites remained switched off because of concerns about over alerting. Getting systems operational meant that little attention was devoted to system optimisation or secondary uses of data. The prescriptions of 1244 patients were audited pre computerised provider order entry and 1178 post computerised provider order entry implementation of system A at sites J and K, and system B at site S. A total of 21,138 opportunities for error were identified from 28,526 prescriptions. Across the three sites, for those prescriptions for which opportunities for error were identified, the error rate was found to reduce significantly ","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83386871","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
L. Wyld, M. Reed, K. Collins, S. Ward, G. Holmes, J. Morgan, M. Bradburn, S. Walters, M. Burton, K. Lifford, A. Edwards, K. Brain, A. Ring, E. Herbert, T. Robinson, Charlene Martin, T. Chater, K. Pemberton, A. Shrestha, A. Nettleship, P. Richards, A. Brennan, K. Cheung, A. Todd, H. Harder, R. Audisio, N. Battisti, J. Wright, R. Simcock, C. Murray, A. Thompson, M. Gosney, M. Hatton, F. Armitage, J. Patnick, T. Green, D. Revill, J. Gath, K. Horgan, C. Holcombe, M. Winter, J. Naik, R. Parmeshwar
In breast cancer management, age-related practice variation is widespread, with older women having lower rates of surgery and chemotherapy than younger women, based on the premise of reduced treatment tolerance and benefit. This may contribute to inferior outcomes. There are currently no age- and fitness-stratified guidelines on which to base treatment recommendations. We aimed to optimise treatment choice and outcomes for older women (aged ≥ 70 years) with operable breast cancer. Our objectives were to (1) determine the age, comorbidity, frailty, disease stage and biology thresholds for endocrine therapy alone versus surgery plus adjuvant endocrine therapy, or adjuvant chemotherapy versus no chemotherapy, for older women with breast cancer; (2) optimise survival outcomes for older women by improving the quality of treatment decision-making; (3) develop and evaluate a decision support intervention to enhance shared decision-making; and (4) determine the degree and causes of treatment variation between UK breast units. A prospective cohort study was used to determine age and fitness thresholds for treatment allocation. Mixed-methods research was used to determine the information needs of older women to develop a decision support intervention. A cluster-randomised trial was used to evaluate the impact of this decision support intervention on treatment choices and outcomes. Health economic analysis was used to evaluate the cost–benefit ratio of different treatment strategies according to age and fitness criteria. A mixed-methods study was used to determine the degree and causes of variation in treatment allocation. The main outcome measures were enhanced age- and fitness-specific decision support leading to improved quality-of-life outcomes in older women (aged ≥ 70 years) with early breast cancer. (1) Cohort study: the study recruited 3416 UK women aged ≥ 70 years (median age 77 years). Follow-up was 52 months. (a) The surgery plus adjuvant endocrine therapy versus endocrine therapy alone comparison: 2854 out of 3416 (88%) women had oestrogen-receptor-positive breast cancer, 2354 of whom received surgery plus adjuvant endocrine therapy and 500 received endocrine therapy alone. Patients treated with endocrine therapy alone were older and frailer than patients treated with surgery plus adjuvant endocrine therapy. Unmatched overall survival and breast-cancer-specific survival were higher in the surgery plus adjuvant endocrine therapy group (overall survival: hazard ratio 0.27, 95% confidence interval 0.23 to 0.33; p < 0.001; breast-cancer-specific survival: hazard ratio 0.41, 95% confidence interval 0.29 to 0.58; p < 0.001) than in the endocrine therapy alone group. In matched analysis, surgery plus adjuvant endocrine therapy was still associated with better overall survival (hazard ratio 0.72, 95% confidence interval 0.53 to 0.98; p = 0.04) than endocrine therapy alone, but not with better breast-cancer-specific
{"title":"Improving outcomes for women aged 70 years or above with early breast cancer: research programme including a cluster RCT","authors":"L. Wyld, M. Reed, K. Collins, S. Ward, G. Holmes, J. Morgan, M. Bradburn, S. Walters, M. Burton, K. Lifford, A. Edwards, K. Brain, A. Ring, E. Herbert, T. Robinson, Charlene Martin, T. Chater, K. Pemberton, A. Shrestha, A. Nettleship, P. Richards, A. Brennan, K. Cheung, A. Todd, H. Harder, R. Audisio, N. Battisti, J. Wright, R. Simcock, C. Murray, A. Thompson, M. Gosney, M. Hatton, F. Armitage, J. Patnick, T. Green, D. Revill, J. Gath, K. Horgan, C. Holcombe, M. Winter, J. Naik, R. Parmeshwar","doi":"10.3310/xzoe2552","DOIUrl":"https://doi.org/10.3310/xzoe2552","url":null,"abstract":"\u0000 \u0000 In breast cancer management, age-related practice variation is widespread, with older women having lower rates of surgery and chemotherapy than younger women, based on the premise of reduced treatment tolerance and benefit. This may contribute to inferior outcomes. There are currently no age- and fitness-stratified guidelines on which to base treatment recommendations.\u0000 \u0000 \u0000 \u0000 We aimed to optimise treatment choice and outcomes for older women (aged ≥ 70 years) with operable breast cancer.\u0000 \u0000 \u0000 \u0000 Our objectives were to (1) determine the age, comorbidity, frailty, disease stage and biology thresholds for endocrine therapy alone versus surgery plus adjuvant endocrine therapy, or adjuvant chemotherapy versus no chemotherapy, for older women with breast cancer; (2) optimise survival outcomes for older women by improving the quality of treatment decision-making; (3) develop and evaluate a decision support intervention to enhance shared decision-making; and (4) determine the degree and causes of treatment variation between UK breast units.\u0000 \u0000 \u0000 \u0000 A prospective cohort study was used to determine age and fitness thresholds for treatment allocation. Mixed-methods research was used to determine the information needs of older women to develop a decision support intervention. A cluster-randomised trial was used to evaluate the impact of this decision support intervention on treatment choices and outcomes. Health economic analysis was used to evaluate the cost–benefit ratio of different treatment strategies according to age and fitness criteria. A mixed-methods study was used to determine the degree and causes of variation in treatment allocation.\u0000 \u0000 \u0000 \u0000 The main outcome measures were enhanced age- and fitness-specific decision support leading to improved quality-of-life outcomes in older women (aged ≥ 70 years) with early breast cancer.\u0000 \u0000 \u0000 \u0000 (1) Cohort study: the study recruited 3416 UK women aged ≥ 70 years (median age 77 years). Follow-up was 52 months. (a) The surgery plus adjuvant endocrine therapy versus endocrine therapy alone comparison: 2854 out of 3416 (88%) women had oestrogen-receptor-positive breast cancer, 2354 of whom received surgery plus adjuvant endocrine therapy and 500 received endocrine therapy alone. Patients treated with endocrine therapy alone were older and frailer than patients treated with surgery plus adjuvant endocrine therapy. Unmatched overall survival and breast-cancer-specific survival were higher in the surgery plus adjuvant endocrine therapy group (overall survival: hazard ratio 0.27, 95% confidence interval 0.23 to 0.33; p < 0.001; breast-cancer-specific survival: hazard ratio 0.41, 95% confidence interval 0.29 to 0.58; p < 0.001) than in the endocrine therapy alone group. In matched analysis, surgery plus adjuvant endocrine therapy was still associated with better overall survival (hazard ratio 0.72, 95% confidence interval 0.53 to 0.98; p = 0.04) than endocrine therapy alone, but not with better breast-cancer-specific","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83203466","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
L. Howard, K. M. Abel, Katie H. Atmore, D. Bick, A. Bye, S. Byford, L. Carson, C. Dolman, M. Heslin, M. Hunter, S. Jennings, Sonia Johnson, I. Jones, B. Taylor, Rebecca McDonald, J. Milgrom, N. Morant, S. Nath, S. Pawlby, L. Potts, C. Powell, D. Rose, E. Ryan, G. Seneviratne, R. Shallcross, N. Stanley, K. Trevillion, A. Wieck, A. Pickles
It is unclear how best to identify and treat women with mental disorders in pregnancy and the year after birth (i.e. the perinatal period). (1) To investigate how best to identify depression at antenatal booking [work package (WP) 1]. (2) To estimate the prevalence of mental disorders in early pregnancy (WP1). (3) To develop and examine the efficacy of a guided self-help intervention for mild to moderate antenatal depression delivered by psychological well-being practitioners (WP1). (4) To examine the psychometric properties of the perinatal VOICE (Views On Inpatient CarE) measure of service satisfaction (WP3). (5) To examine the clinical effectiveness and cost-effectiveness of services for women with acute severe postnatal mental disorders (WPs 1–3). (6) To investigate women’s and partners’/significant others’ experiences of different types of care (WP2). Objectives 1 and 2 – a cross-sectional survey stratified by response to Whooley depression screening questions. Objective 3 – an exploratory randomised controlled trial. Objective 4 – an exploratory factor analysis, including test–retest reliability and validity assessed by association with the Client Satisfaction Questionnaire contemporaneous satisfaction scores. Objective 5 – an observational cohort study using propensity scores for the main analysis and instrumental variable analysis using geographical distance to mother and baby unit. Objective 6 – a qualitative study. English maternity services and generic and specialist mental health services for pregnant and postnatal women. Staff and users of mental health and maternity services. Guided self-help, mother and baby units and generic care. The following measures were evaluated in WP1(i) – specificity, sensitivity, positive predictive value, likelihood ratio, acceptability and population prevalence estimates. The following measures were evaluated in WP1(ii) – participant recruitment rate, attrition and adverse events. The following measure was evaluated in WP2 – experiences of care. The following measures were evaluated in WP3 – psychometric indices for perinatal VOICE and the proportion of participants readmitted to acute care in the year after discharge. WP1(i) – the population prevalence estimate was 11% (95% confidence interval 8% to 14%) for depression and 27% (95% confidence interval 22% to 32%) for any mental disorder in early pregnancy. The diagnostic accuracy of two depression screening questions was as follows: a weighted sensitivity of 0.41, a specificity of 0.95, a positive predictive value of 0.45, a negative predictive value of 0.93 and a likelihood ratio (positive) of 8.2. For the Edinburgh Postnatal Depression Scale, the diagnostic accuracy was as follows: a weighted sensitivity of 0.59, a specificity of 0.94, a positive predictive value of 0.52, a negative predictive value of 0.95 and a likelihood ratio (positive) of 9.8. Most women reported that asking about depression a
{"title":"Perinatal mental health services in pregnancy and the year after birth: the ESMI research programme including RCT","authors":"L. Howard, K. M. Abel, Katie H. Atmore, D. Bick, A. Bye, S. Byford, L. Carson, C. Dolman, M. Heslin, M. Hunter, S. Jennings, Sonia Johnson, I. Jones, B. Taylor, Rebecca McDonald, J. Milgrom, N. Morant, S. Nath, S. Pawlby, L. Potts, C. Powell, D. Rose, E. Ryan, G. Seneviratne, R. Shallcross, N. Stanley, K. Trevillion, A. Wieck, A. Pickles","doi":"10.3310/ccht9881","DOIUrl":"https://doi.org/10.3310/ccht9881","url":null,"abstract":"\u0000 \u0000 It is unclear how best to identify and treat women with mental disorders in pregnancy and the year after birth (i.e. the perinatal period).\u0000 \u0000 \u0000 \u0000 (1) To investigate how best to identify depression at antenatal booking [work package (WP) 1]. (2) To estimate the prevalence of mental disorders in early pregnancy (WP1). (3) To develop and examine the efficacy of a guided self-help intervention for mild to moderate antenatal depression delivered by psychological well-being practitioners (WP1). (4) To examine the psychometric properties of the perinatal VOICE (Views On Inpatient CarE) measure of service satisfaction (WP3). (5) To examine the clinical effectiveness and cost-effectiveness of services for women with acute severe postnatal mental disorders (WPs 1–3). (6) To investigate women’s and partners’/significant others’ experiences of different types of care (WP2).\u0000 \u0000 \u0000 \u0000 Objectives 1 and 2 – a cross-sectional survey stratified by response to Whooley depression screening questions. Objective 3 – an exploratory randomised controlled trial. Objective 4 – an exploratory factor analysis, including test–retest reliability and validity assessed by association with the Client Satisfaction Questionnaire contemporaneous satisfaction scores. Objective 5 – an observational cohort study using propensity scores for the main analysis and instrumental variable analysis using geographical distance to mother and baby unit. Objective 6 – a qualitative study.\u0000 \u0000 \u0000 \u0000 English maternity services and generic and specialist mental health services for pregnant and postnatal women.\u0000 \u0000 \u0000 \u0000 Staff and users of mental health and maternity services.\u0000 \u0000 \u0000 \u0000 Guided self-help, mother and baby units and generic care.\u0000 \u0000 \u0000 \u0000 The following measures were evaluated in WP1(i) – specificity, sensitivity, positive predictive value, likelihood ratio, acceptability and population prevalence estimates. The following measures were evaluated in WP1(ii) – participant recruitment rate, attrition and adverse events. The following measure was evaluated in WP2 – experiences of care. The following measures were evaluated in WP3 – psychometric indices for perinatal VOICE and the proportion of participants readmitted to acute care in the year after discharge.\u0000 \u0000 \u0000 \u0000 WP1(i) – the population prevalence estimate was 11% (95% confidence interval 8% to 14%) for depression and 27% (95% confidence interval 22% to 32%) for any mental disorder in early pregnancy. The diagnostic accuracy of two depression screening questions was as follows: a weighted sensitivity of 0.41, a specificity of 0.95, a positive predictive value of 0.45, a negative predictive value of 0.93 and a likelihood ratio (positive) of 8.2. For the Edinburgh Postnatal Depression Scale, the diagnostic accuracy was as follows: a weighted sensitivity of 0.59, a specificity of 0.94, a positive predictive value of 0.52, a negative predictive value of 0.95 and a likelihood ratio (positive) of 9.8. Most women reported that asking about depression a","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74890552","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
C. Price, P. White, J. Balami, N. Bhattarai, D. Coughlan, C. Exley, D. Flynn, K. Halvorsrud, J. Lally, P. McMeekin, Lisa Shaw, H. Snooks, L. Vale, A. Watkins, G. Ford
Intravenous thrombolysis and intra-arterial thrombectomy are proven emergency treatments for acute ischaemic stroke, but they require rapid delivery to selected patients within specialist services. National audit data have shown that treatment provision is suboptimal. The aims were to (1) determine the content, clinical effectiveness and day 90 cost-effectiveness of an enhanced paramedic assessment designed to facilitate thrombolysis delivery in hospital and (2) model thrombectomy service configuration options with optimal activity and cost-effectiveness informed by expert and public views. A mixed-methods approach was employed between 2014 and 2019. Systematic reviews examined enhanced paramedic roles and thrombectomy effectiveness. Professional and service user groups developed a thrombolysis-focused Paramedic Acute Stroke Treatment Assessment, which was evaluated in a pragmatic multicentre cluster randomised controlled trial and parallel process evaluation. Clinicians, patients, carers and the public were surveyed regarding thrombectomy service configuration. A decision tree was constructed from published data to estimate thrombectomy eligibility of the UK stroke population. A matching discrete-event simulation predicted patient benefits and financial consequences from increasing the number of centres. The paramedic assessment trial was hosted by three regional ambulance services (in north-east England, north-west England and Wales) serving 15 hospitals. A total of 103 health-care representatives and 20 public representatives assisted in the development of the paramedic assessment. The trial enrolled 1214 stroke patients within 4 hours of symptom onset. Thrombectomy service provision was informed by a Delphi exercise with 64 stroke specialists and neuroradiologists, and surveys of 147 patients and 105 public respondents. The paramedic assessment comprised additional pre-hospital information collection, structured hospital handover, practical assistance up to 15 minutes post handover, a pre-departure care checklist and clinician feedback. The primary outcome was the proportion of patients receiving thrombolysis. Secondary outcomes included day 90 health (poor status was a modified Rankin Scale score of > 2). Economic outputs reported the number of cases treated and cost-effectiveness using quality-adjusted life-years and Great British pounds. National registry data from the Sentinel Stroke National Audit Programme and the Scottish Stroke Care Audit were used. Systematic searches of electronic bibliographies were used to identify relevant literature. Study inclusion and data extraction processes were described using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The paramedic assessment trial found a clinically important but statistically non-significant reduction in thrombolysis among intervention patients, compared with standard care patients [19
{"title":"Improving emergency treatment for patients with acute stroke: the PEARS research programme, including the PASTA cluster RCT","authors":"C. Price, P. White, J. Balami, N. Bhattarai, D. Coughlan, C. Exley, D. Flynn, K. Halvorsrud, J. Lally, P. McMeekin, Lisa Shaw, H. Snooks, L. Vale, A. Watkins, G. Ford","doi":"10.3310/tzty9915","DOIUrl":"https://doi.org/10.3310/tzty9915","url":null,"abstract":"\u0000 \u0000 Intravenous thrombolysis and intra-arterial thrombectomy are proven emergency treatments for acute ischaemic stroke, but they require rapid delivery to selected patients within specialist services. National audit data have shown that treatment provision is suboptimal.\u0000 \u0000 \u0000 \u0000 The aims were to (1) determine the content, clinical effectiveness and day 90 cost-effectiveness of an enhanced paramedic assessment designed to facilitate thrombolysis delivery in hospital and (2) model thrombectomy service configuration options with optimal activity and cost-effectiveness informed by expert and public views.\u0000 \u0000 \u0000 \u0000 A mixed-methods approach was employed between 2014 and 2019. Systematic reviews examined enhanced paramedic roles and thrombectomy effectiveness. Professional and service user groups developed a thrombolysis-focused Paramedic Acute Stroke Treatment Assessment, which was evaluated in a pragmatic multicentre cluster randomised controlled trial and parallel process evaluation. Clinicians, patients, carers and the public were surveyed regarding thrombectomy service configuration. A decision tree was constructed from published data to estimate thrombectomy eligibility of the UK stroke population. A matching discrete-event simulation predicted patient benefits and financial consequences from increasing the number of centres.\u0000 \u0000 \u0000 \u0000 The paramedic assessment trial was hosted by three regional ambulance services (in north-east England, north-west England and Wales) serving 15 hospitals.\u0000 \u0000 \u0000 \u0000 A total of 103 health-care representatives and 20 public representatives assisted in the development of the paramedic assessment. The trial enrolled 1214 stroke patients within 4 hours of symptom onset. Thrombectomy service provision was informed by a Delphi exercise with 64 stroke specialists and neuroradiologists, and surveys of 147 patients and 105 public respondents.\u0000 \u0000 \u0000 \u0000 The paramedic assessment comprised additional pre-hospital information collection, structured hospital handover, practical assistance up to 15 minutes post handover, a pre-departure care checklist and clinician feedback.\u0000 \u0000 \u0000 \u0000 The primary outcome was the proportion of patients receiving thrombolysis. Secondary outcomes included day 90 health (poor status was a modified Rankin Scale score of > 2). Economic outputs reported the number of cases treated and cost-effectiveness using quality-adjusted life-years and Great British pounds.\u0000 \u0000 \u0000 \u0000 National registry data from the Sentinel Stroke National Audit Programme and the Scottish Stroke Care Audit were used.\u0000 \u0000 \u0000 \u0000 Systematic searches of electronic bibliographies were used to identify relevant literature. Study inclusion and data extraction processes were described using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.\u0000 \u0000 \u0000 \u0000 The paramedic assessment trial found a clinically important but statistically non-significant reduction in thrombolysis among intervention patients, compared with standard care patients [19","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87694714","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
R. Foy, F. Lorencatto, R. Walwyn, A. Farrin, J. Francis, Natalie J Gould, S. McIntyre, Riya Patel, James Smith, Camilla During, S. Hartley, Robert Cicero, L. Glidewell, J. Grant-Casey, M. Rowley, A. Deary, Nicholas Swart, Stephen Morris, M. Collinson, Lauren A Moreau, Jon Bird, S. Michie, J. Grimshaw, S. Stanworth
Blood transfusion is a common but costly treatment. Repeated national audits in the UK suggest that up to one-fifth of transfusions are unnecessary when judged against recommendations for good clinical practice. Audit and feedback seeks to improve patient care and outcomes by comparing clinical care against explicit standards. It is widely used internationally in quality improvement. Audit and feedback generally has modest but variable effects on patient care. A considerable scope exists to improve the impact that audit and feedback has, particularly through head-to-head trials comparing different ways of delivering feedback. The AFFINITIE (Development & Evaluation of Audit and Feedback INterventions to Increase evidence-based Transfusion practIcE) programme aimed to design and evaluate enhanced feedback interventions, within a national blood transfusion audit programme, to promote evidence-based guidance and reduce the unnecessary use of blood components. We developed, piloted and refined two feedback interventions, ‘enhanced content’ and ‘enhanced follow-on’ (workstream 1), evaluated the effectiveness and cost-effectiveness of the two feedback interventions compared with standard feedback practice (workstream 2), examined intervention fidelity and contextual influences (workstream 3) and developed general implementation recommendations and tools for other audit and feedback programmes (workstream 4). Interviews, observations and documentary analysis in four purposively sampled hospitals explored contemporary practice and opportunities for strengthening feedback. We developed two interventions: ‘enhanced content’, to improve the clarity and utility of feedback reports, and ‘enhanced follow-on’, to help hospital staff with action-planning (workstream 1). We conducted two linked 2 × 2 factorial cross-sectional cluster-randomised trials within transfusion audits for major surgery and haematological oncology, respectively (workstream 2). We randomised hospital clusters (the organisational level at which hospital transfusion teams operate) to enhanced or standard content or enhanced or standard follow-on. Outcome assessment was masked to assignment. Decision-analytic modelling evaluated the costs, benefits and cost-effectiveness of the feedback interventions in both trials from the perspective of the NHS. A parallel process evaluation used semistructured interviews, documentary analyses and web analytics to assess the fidelity of delivery, receipt and enactment and to identify contextual influences (workstream 3). We explored ways of improving the impact of national audits with their representatives (workstream 4). All NHS hospital trusts and health boards participating in the National Comparative Audit of Blood Transfusions were invited to take part. Among 189 hospital trusts and health boards screened, 152 hospital clusters participated in the surgical audit. Among 187 hospital trusts and health boards screened, 141 hospita
{"title":"Enhanced feedback interventions to promote evidence-based blood transfusion guidance and reduce unnecessary use of blood components: the AFFINITIE research programme including two cluster factorial RCTs","authors":"R. Foy, F. Lorencatto, R. Walwyn, A. Farrin, J. Francis, Natalie J Gould, S. McIntyre, Riya Patel, James Smith, Camilla During, S. Hartley, Robert Cicero, L. Glidewell, J. Grant-Casey, M. Rowley, A. Deary, Nicholas Swart, Stephen Morris, M. Collinson, Lauren A Moreau, Jon Bird, S. Michie, J. Grimshaw, S. Stanworth","doi":"10.3310/rehp1241","DOIUrl":"https://doi.org/10.3310/rehp1241","url":null,"abstract":"\u0000 \u0000 Blood transfusion is a common but costly treatment. Repeated national audits in the UK suggest that up to one-fifth of transfusions are unnecessary when judged against recommendations for good clinical practice. Audit and feedback seeks to improve patient care and outcomes by comparing clinical care against explicit standards. It is widely used internationally in quality improvement. Audit and feedback generally has modest but variable effects on patient care. A considerable scope exists to improve the impact that audit and feedback has, particularly through head-to-head trials comparing different ways of delivering feedback.\u0000 \u0000 \u0000 \u0000 The AFFINITIE (Development & Evaluation of Audit and Feedback INterventions to Increase evidence-based Transfusion practIcE) programme aimed to design and evaluate enhanced feedback interventions, within a national blood transfusion audit programme, to promote evidence-based guidance and reduce the unnecessary use of blood components. We developed, piloted and refined two feedback interventions, ‘enhanced content’ and ‘enhanced follow-on’ (workstream 1), evaluated the effectiveness and cost-effectiveness of the two feedback interventions compared with standard feedback practice (workstream 2), examined intervention fidelity and contextual influences (workstream 3) and developed general implementation recommendations and tools for other audit and feedback programmes (workstream 4).\u0000 \u0000 \u0000 \u0000 Interviews, observations and documentary analysis in four purposively sampled hospitals explored contemporary practice and opportunities for strengthening feedback. We developed two interventions: ‘enhanced content’, to improve the clarity and utility of feedback reports, and ‘enhanced follow-on’, to help hospital staff with action-planning (workstream 1). We conducted two linked 2 × 2 factorial cross-sectional cluster-randomised trials within transfusion audits for major surgery and haematological oncology, respectively (workstream 2). We randomised hospital clusters (the organisational level at which hospital transfusion teams operate) to enhanced or standard content or enhanced or standard follow-on. Outcome assessment was masked to assignment. Decision-analytic modelling evaluated the costs, benefits and cost-effectiveness of the feedback interventions in both trials from the perspective of the NHS. A parallel process evaluation used semistructured interviews, documentary analyses and web analytics to assess the fidelity of delivery, receipt and enactment and to identify contextual influences (workstream 3). We explored ways of improving the impact of national audits with their representatives (workstream 4).\u0000 \u0000 \u0000 \u0000 All NHS hospital trusts and health boards participating in the National Comparative Audit of Blood Transfusions were invited to take part. Among 189 hospital trusts and health boards screened, 152 hospital clusters participated in the surgical audit. Among 187 hospital trusts and health boards screened, 141 hospita","PeriodicalId":32307,"journal":{"name":"Programme Grants for Applied Research","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74534666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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