Pub Date : 2024-04-18DOI: 10.3310/nihropenres.13559.1
Tracy L Finch, Leah Bührmann, Sebastian Potthoff, Carl R May, Beckie Gibson, Jiri Gumancik, Oliver Wilson-Dickson, M. Girling, Tim Rapley
Background Implementation outcomes measures can be used to assess the implementation of complex health and social care interventions, but evidence for the use of these measures, and their psychometric properties, remains limited. The NoMAD (Normalisation Measure Development) survey, based on Normalisation Process Theory, was developed to assess, monitor, or measure factors likely to affect normalisation of a new practice from the perspective of participants who are engaged in an implementation process. Since publication in 2015, NoMAD has been translated into several languages and is increasingly being used in health and care research. This systematic review will identify, appraise, and synthesise the existing literature on the use of NoMAD as an implementation outcome measure, focusing on use and application across different studies and settings, and on its properties as a measurement tool. Methods We will systematically search the bibliographic databases Web of Science, Scopus and PubMed for articles reporting empirical data in peer-reviewed journals. A citation search will also be undertaken in Google Scholar for primary NoMAD publications. Studies will be eligible for inclusion if they: (a) specify using NoMAD as a method and report results from using it, and/or (b) report a translation and/or validation study of NoMAD’s measurement properties. Screening of abstracts and full text articles will be done independently by two researchers. Data extraction will be structured to allow collection and descriptive synthesis of data on study characteristics, use of NoMAD, psychometric results, and authors’ reflections and recommendations. Conclusions This review will provide the first synthesis of how NoMAD has been applied in health and care research, and evidence on its properties as an outcome measure since its publication. This will be used to update existing freely accessible guidance for researchers and other users, and disseminated through peer-reviewed publications, and engagement activities with researchers and practitioners.
{"title":"Systematic review of applications and properties of the NoMAD instrument for assessing implementation outcomes: Study protocol","authors":"Tracy L Finch, Leah Bührmann, Sebastian Potthoff, Carl R May, Beckie Gibson, Jiri Gumancik, Oliver Wilson-Dickson, M. Girling, Tim Rapley","doi":"10.3310/nihropenres.13559.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13559.1","url":null,"abstract":"Background Implementation outcomes measures can be used to assess the implementation of complex health and social care interventions, but evidence for the use of these measures, and their psychometric properties, remains limited. The NoMAD (Normalisation Measure Development) survey, based on Normalisation Process Theory, was developed to assess, monitor, or measure factors likely to affect normalisation of a new practice from the perspective of participants who are engaged in an implementation process. Since publication in 2015, NoMAD has been translated into several languages and is increasingly being used in health and care research. This systematic review will identify, appraise, and synthesise the existing literature on the use of NoMAD as an implementation outcome measure, focusing on use and application across different studies and settings, and on its properties as a measurement tool. Methods We will systematically search the bibliographic databases Web of Science, Scopus and PubMed for articles reporting empirical data in peer-reviewed journals. A citation search will also be undertaken in Google Scholar for primary NoMAD publications. Studies will be eligible for inclusion if they: (a) specify using NoMAD as a method and report results from using it, and/or (b) report a translation and/or validation study of NoMAD’s measurement properties. Screening of abstracts and full text articles will be done independently by two researchers. Data extraction will be structured to allow collection and descriptive synthesis of data on study characteristics, use of NoMAD, psychometric results, and authors’ reflections and recommendations. Conclusions This review will provide the first synthesis of how NoMAD has been applied in health and care research, and evidence on its properties as an outcome measure since its publication. This will be used to update existing freely accessible guidance for researchers and other users, and disseminated through peer-reviewed publications, and engagement activities with researchers and practitioners.","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":" 10","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140690028","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}
Pub Date : 2024-04-17DOI: 10.3310/nihropenres.13550.1
J. Matthewman, Kirsty Andresen, Anne Suffel, Liang-Yu Lin, Anna Schultze, J. Tazare, K. Bhaskaran, Elizabeth Williamson, R. Costello, Jennifer Quint, H. Strongman
Background Codelists are required to extract meaningful information on characteristics and events from electronic health records (EHRs). EHR research relies on codelists to define study populations and variables, thus, trustworthy codelists are important. Here, we provide a checklist, in the style of commonly used reporting guidelines, to help researchers adhere to best practice in codelist development and sharing. Methods Based on a literature search and a workshop with experienced EHR researchers we created a set of recommendations that are 1. broadly applicable to different datasets, research questions, and methods of codelist creation; 2. easy to follow, implement and document by an individual researcher, and 3. fit within a step-by-step process. We then formatted these recommendations into a checklist. Results We have created a 9-step checklist, comprising 26 items, with accompanying guidance on each step. The checklist advises on which metadata to provide, how to define a clinical concept, how to identify and evaluate existing codelists, how to create new codelists, and how to review, finalise, and publish a created codelist. Conclusions Use of the checklist can reassure researchers that best practice was followed during the development of their codelists, increasing trust in research that relies on these codelists and facilitating wider re-use and adaptation by other researchers.
{"title":"Checklist and guidance on creating codelists for electronic health records research","authors":"J. Matthewman, Kirsty Andresen, Anne Suffel, Liang-Yu Lin, Anna Schultze, J. Tazare, K. Bhaskaran, Elizabeth Williamson, R. Costello, Jennifer Quint, H. Strongman","doi":"10.3310/nihropenres.13550.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13550.1","url":null,"abstract":"Background Codelists are required to extract meaningful information on characteristics and events from electronic health records (EHRs). EHR research relies on codelists to define study populations and variables, thus, trustworthy codelists are important. Here, we provide a checklist, in the style of commonly used reporting guidelines, to help researchers adhere to best practice in codelist development and sharing. Methods Based on a literature search and a workshop with experienced EHR researchers we created a set of recommendations that are 1. broadly applicable to different datasets, research questions, and methods of codelist creation; 2. easy to follow, implement and document by an individual researcher, and 3. fit within a step-by-step process. We then formatted these recommendations into a checklist. Results We have created a 9-step checklist, comprising 26 items, with accompanying guidance on each step. The checklist advises on which metadata to provide, how to define a clinical concept, how to identify and evaluate existing codelists, how to create new codelists, and how to review, finalise, and publish a created codelist. Conclusions Use of the checklist can reassure researchers that best practice was followed during the development of their codelists, increasing trust in research that relies on these codelists and facilitating wider re-use and adaptation by other researchers.","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"220 S712","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140693243","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}
Pub Date : 2024-04-16DOI: 10.3310/nihropenres.13532.1
Sharanya Mahesh, Ila Bharatan, Robin Miller
Background There has been increasing emphasis towards adopting strengths-based practice (SBP) within adult social care in England. Whilst there is agreement that SBP is the right approach to discharge adult social care duties, there is limited evidence regarding the implementation of SBP. This paper presents findings from the evaluation of the implementation of SBP in fourteen local authorities in one region in England. Methods We employed a mixed methods research design, drawing on data from a scoping review, 36 interviews with practice leaders and two surveys, one with wider adult social care staff and the other, with external organisations like independent care providers and community and voluntary organisations. Our data collection and analysis were guided by two well established implementation theories: the Consolidated Framework for Implementation Research (CFIR) and Normalisation Process Theory (NPT). Interviews were analysed deductively, and surveys were analysed descriptively. Results Local authorities are at different stages in their implementation journey. The Care Act 2014 and support for SBP demonstrated by key professional groups were seen as major drivers for implementing SBP. Whilst SBP resonated with the professional principles of social workers and occupational therapists, staff did not always have the confidence and skills to adapt to SBP. Changing paperwork and recording systems, providing training opportunities to develop staff competencies, establishing new care pathways, genuine co-production, and senior management buy-in were key enablers supporting implementation. Conclusions To successfully implement SBP, a whole system approach that meaningfully collaborates with key professionals across sectors is essential. When implemented well, SBP has the potential to empower individuals by focusing on what matters to them.
{"title":"Strengths-based practice in adult social care: Understanding implementation","authors":"Sharanya Mahesh, Ila Bharatan, Robin Miller","doi":"10.3310/nihropenres.13532.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13532.1","url":null,"abstract":"Background There has been increasing emphasis towards adopting strengths-based practice (SBP) within adult social care in England. Whilst there is agreement that SBP is the right approach to discharge adult social care duties, there is limited evidence regarding the implementation of SBP. This paper presents findings from the evaluation of the implementation of SBP in fourteen local authorities in one region in England. Methods We employed a mixed methods research design, drawing on data from a scoping review, 36 interviews with practice leaders and two surveys, one with wider adult social care staff and the other, with external organisations like independent care providers and community and voluntary organisations. Our data collection and analysis were guided by two well established implementation theories: the Consolidated Framework for Implementation Research (CFIR) and Normalisation Process Theory (NPT). Interviews were analysed deductively, and surveys were analysed descriptively. Results Local authorities are at different stages in their implementation journey. The Care Act 2014 and support for SBP demonstrated by key professional groups were seen as major drivers for implementing SBP. Whilst SBP resonated with the professional principles of social workers and occupational therapists, staff did not always have the confidence and skills to adapt to SBP. Changing paperwork and recording systems, providing training opportunities to develop staff competencies, establishing new care pathways, genuine co-production, and senior management buy-in were key enablers supporting implementation. Conclusions To successfully implement SBP, a whole system approach that meaningfully collaborates with key professionals across sectors is essential. When implemented well, SBP has the potential to empower individuals by focusing on what matters to them.","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"31 25","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140696756","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}
Pub Date : 2024-04-12DOI: 10.3310/nihropenres.13551.1
Alison Booth, Catriona McDaid, Ashley Scrimshire, Harvinda Singh, A. Scantlebury, C. Hewitt
Background There is strong evidence that those recruited into studies are not always representative of the population for whom the research is most relevant. Development of the study design and funding decisions are points in the research process where considerations about inclusion of under-served populations may usefully be made. Current practical guidance focuses on designing and modifying participant recruitment and retention approaches but an area that has not been addressed is recruitment site selection. Methods We present case studies of three NIHR funded trials to demonstrate how publicly available UK population datasets can be used to facilitate the identification of under-served communities for inclusion in trials. The trials have different designs, address different needs and demonstrate recruitment planning across Trauma centres, NHS Trusts and special educational settings. We describe our use of national freely available datasets, such as those provided by NHS Digital and the Office for National Statistics, to identify potential recruitment sites with consideration of health status, socio-economic status and ethnicity as well as clinical and risk factors to support inclusivity. For all three studies, we produced lists of potential recruitment sites in excess of the number anticipated as necessary to meet the recruitment targets. Discussion We reflect on the challenges to our approach and some potential future developments. The datasets used are all free to use but each has their limitations. Agreeing search parameters, acceptable proxies and identifying the appropriate datasets, then cross referencing between datasets takes considerable time and particular expertise. The case studies are trials, but the methods are generalisable for various other study types. Conclusion Through these exemplars, we aim to build on the NIHR INCLUDE project, by providing trialists with a much needed practical approach to embedding EDI into trial design at the grant application stage.
背景 有确凿证据表明，研究中招募的人员并不总是代表与研究最相关的人群。在研究过程中，研究设计的制定和资助决策都需要考虑是否纳入服务不足的人群。目前的实用指南侧重于设计和修改参与者招募与保留方法，但尚未涉及招募地点的选择。方法 我们介绍了三项由英国国家卫生研究院（NIHR）资助的试验的案例研究，以展示如何利用可公开获得的英国人口数据集来帮助识别服务不足的群体，并将其纳入试验。这些试验具有不同的设计，针对不同的需求，并展示了创伤中心、NHS 信托基金会和特殊教育机构的招募规划。我们介绍了如何利用国家免费提供的数据集（如由 NHS Digital 和国家统计局提供的数据集）来确定潜在的招募地点，同时考虑健康状况、社会经济状况、种族以及临床和风险因素，以支持包容性。对于所有三项研究，我们都编制了潜在招募地点清单，其数量超过了预期数量，这是实现招募目标所必需的。讨论 我们反思了我们的方法所面临的挑战以及未来可能的发展。我们使用的数据集都是免费的，但每个数据集都有其局限性。商定搜索参数、可接受的替代方法、确定适当的数据集，然后在数据集之间进行交叉引用，这些都需要大量的时间和特殊的专业知识。案例研究是试验研究，但这些方法可用于其他各种研究类型。结论 通过这些范例，我们旨在以 NIHR INCLUDE 项目为基础，为试验人员提供急需的实用方法，以便在申请基金阶段将 EDI 嵌入试验设计中。
{"title":"Using publicly available UK datasets to identify recruitment sites to maximise inclusion of under-served groups: three case studies","authors":"Alison Booth, Catriona McDaid, Ashley Scrimshire, Harvinda Singh, A. Scantlebury, C. Hewitt","doi":"10.3310/nihropenres.13551.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13551.1","url":null,"abstract":"Background There is strong evidence that those recruited into studies are not always representative of the population for whom the research is most relevant. Development of the study design and funding decisions are points in the research process where considerations about inclusion of under-served populations may usefully be made. Current practical guidance focuses on designing and modifying participant recruitment and retention approaches but an area that has not been addressed is recruitment site selection. Methods We present case studies of three NIHR funded trials to demonstrate how publicly available UK population datasets can be used to facilitate the identification of under-served communities for inclusion in trials. The trials have different designs, address different needs and demonstrate recruitment planning across Trauma centres, NHS Trusts and special educational settings. We describe our use of national freely available datasets, such as those provided by NHS Digital and the Office for National Statistics, to identify potential recruitment sites with consideration of health status, socio-economic status and ethnicity as well as clinical and risk factors to support inclusivity. For all three studies, we produced lists of potential recruitment sites in excess of the number anticipated as necessary to meet the recruitment targets. Discussion We reflect on the challenges to our approach and some potential future developments. The datasets used are all free to use but each has their limitations. Agreeing search parameters, acceptable proxies and identifying the appropriate datasets, then cross referencing between datasets takes considerable time and particular expertise. The case studies are trials, but the methods are generalisable for various other study types. Conclusion Through these exemplars, we aim to build on the NIHR INCLUDE project, by providing trialists with a much needed practical approach to embedding EDI into trial design at the grant application stage.","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"82 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140709465","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}
Pub Date : 2024-04-08eCollection Date: 2023-01-01DOI: 10.3310/nihropenres.13507.2
Kavita Biggin, Ioana R Marian, Sarah E Lamb, Alana Morris, Caoileann Murphy, Andrew Carver, Nirvana Croft, Esther Williamson
Background Frailty is a common syndrome affecting older people and puts them at risk of hospitalisation, needing care or death. First signs of frailty include reduced muscle strength and mobility decline. A key cause of mobility decline as we age is sarcopenia (age related reduction in muscle strength and mass). Poor nutrition contributes to sarcopenia. A shortfall in protein is associated with reduced muscle mass and strength. This may be due to inadequate intake but also because older people have higher protein needs, especially those with multimorbidity. We need to develop effective treatment to reduce or slow the onset of frailty and mobility decline. Exercise is a recommended treatment. Protein supplements to address the shortfall in protein have the potential to enhance the benefit of regular exercise in frail or pre-frail older adults. This has yet to be definitively demonstrated. Aim To establish the feasibility of conducting an RCT evaluating mobility and strength training with or without protein supplements for people over 60 years old who are frail or pre-frail with a low protein intake. Methods A multicentre, parallel, 2-group, feasibility RCT. Participants (recruitment target = 50) with problems walking, low protein intake and classified as frail or pre-frail will be recruited from four NHS Physiotherapy community services. Participants will be randomised (secure computer-generated: 1:1) to receive 24 weeks of mobility and strength training (delivered in 16 group sessions plus home exercises) or 24 weeks of mobility and strength training with daily protein supplements. Primary feasibility objectives are to estimate 1) ability to screen and recruit eligible participants, 2) intervention fidelity, adherence, and tolerance and 3) retention of participants at follow up. Secondary objectives are to 1) test data collection procedures, 2) assess data completeness and 3) confirm sample size calculation for a definitive RCT. Registration ISRCTN Registry (ISRCTN30405954; 18/10/2022).
{"title":"Mobility and strength training with and without protein supplements for pre-frail or frail older adults with low protein intake: the Maximising Mobility and Strength Training (MMoST) feasibility randomised controlled trial protocol.","authors":"Kavita Biggin, Ioana R Marian, Sarah E Lamb, Alana Morris, Caoileann Murphy, Andrew Carver, Nirvana Croft, Esther Williamson","doi":"10.3310/nihropenres.13507.2","DOIUrl":"10.3310/nihropenres.13507.2","url":null,"abstract":"<p><p>Background Frailty is a common syndrome affecting older people and puts them at risk of hospitalisation, needing care or death. First signs of frailty include reduced muscle strength and mobility decline. A key cause of mobility decline as we age is sarcopenia (age related reduction in muscle strength and mass). Poor nutrition contributes to sarcopenia. A shortfall in protein is associated with reduced muscle mass and strength. This may be due to inadequate intake but also because older people have higher protein needs, especially those with multimorbidity. We need to develop effective treatment to reduce or slow the onset of frailty and mobility decline. Exercise is a recommended treatment. Protein supplements to address the shortfall in protein have the potential to enhance the benefit of regular exercise in frail or pre-frail older adults. This has yet to be definitively demonstrated. Aim To establish the feasibility of conducting an RCT evaluating mobility and strength training with or without protein supplements for people over 60 years old who are frail or pre-frail with a low protein intake. Methods A multicentre, parallel, 2-group, feasibility RCT. Participants (recruitment target = 50) with problems walking, low protein intake and classified as frail or pre-frail will be recruited from four NHS Physiotherapy community services. Participants will be randomised (secure computer-generated: 1:1) to receive 24 weeks of mobility and strength training (delivered in 16 group sessions plus home exercises) or 24 weeks of mobility and strength training with daily protein supplements. Primary feasibility objectives are to estimate 1) ability to screen and recruit eligible participants, 2) intervention fidelity, adherence, and tolerance and 3) retention of participants at follow up. Secondary objectives are to 1) test data collection procedures, 2) assess data completeness and 3) confirm sample size calculation for a definitive RCT. Registration ISRCTN Registry (ISRCTN30405954; 18/10/2022).</p>","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"3 ","pages":"62"},"PeriodicalIF":0.0,"publicationDate":"2024-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11319903/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141977408","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-05DOI: 10.3310/nihropenres.13543.1
Lawrence O’Leary, William Sherwood, Michael Fadel, Musa Barkeji
Background Routine group and save (G&S) testing is frequently performed prior to cholecystectomy, despite growing evidence that a targeted approach is safe and avoids unnecessary investigations. This retrospective cohort study explored frequency of testing in our unit, and rates of and independent pre-operative risk factors for peri-operative blood transfusion. Methods Health records of 453 consecutive adults who underwent cholecystectomy in a UK NHS trust were reviewed for blood transfusion up to 30 days post-operatively. We compared the need for transfusion against patient demographics, indication and urgency of surgery, and the number of prior emergency hospital attendances with gallstone complications. Logistic regression determined whether prior attendances with complications of gallstones independently predicted the need for transfusion. Results Peri-operative blood transfusions within 30 days of operation occurred in 1.1% of cases, with no requirement for uncrossmatched blood. Patients who received a blood transfusion tended to have higher American Society of Anesthesiologists (ASA) grades (p<0.001), were more likely to have an underlying primary haematological malignancy (20.0% vs. 0.2%; p<0.001) and prior emergency hospital attendances with gallstone complications (median 4 vs. 1; p<0.001). Logistic regression showed each prior emergency attendance was associated with 4.6-fold odds of transfusion (p=0.019). Receiver operating characteristic curve analysis showed an area under the curve of 0.92. Three or more attendances predicted need for transfusion with 60.0% sensitivity and 98.0% specificity. Seventy-four percent had at least one G&S sample taken pre-operatively, costing the trust approximately £3,800 per year in materials. Conclusions Pre-operative G&S testing prior to cholecystectomy may not be routinely required. Increased frequency of prior emergency hospital attendances with gallstone complications and co-morbidities associated with coagulopathies were pre-operative risk factors for post-operative blood transfusion. More selective testing could provide large financial savings for health institutions without compromising patient safety.
{"title":"Assessment of routine pre-operative group and save testing in patients undergoing cholecystectomy: a retrospective cohort study","authors":"Lawrence O’Leary, William Sherwood, Michael Fadel, Musa Barkeji","doi":"10.3310/nihropenres.13543.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13543.1","url":null,"abstract":"Background Routine group and save (G&S) testing is frequently performed prior to cholecystectomy, despite growing evidence that a targeted approach is safe and avoids unnecessary investigations. This retrospective cohort study explored frequency of testing in our unit, and rates of and independent pre-operative risk factors for peri-operative blood transfusion. Methods Health records of 453 consecutive adults who underwent cholecystectomy in a UK NHS trust were reviewed for blood transfusion up to 30 days post-operatively. We compared the need for transfusion against patient demographics, indication and urgency of surgery, and the number of prior emergency hospital attendances with gallstone complications. Logistic regression determined whether prior attendances with complications of gallstones independently predicted the need for transfusion. Results Peri-operative blood transfusions within 30 days of operation occurred in 1.1% of cases, with no requirement for uncrossmatched blood. Patients who received a blood transfusion tended to have higher American Society of Anesthesiologists (ASA) grades (p<0.001), were more likely to have an underlying primary haematological malignancy (20.0% vs. 0.2%; p<0.001) and prior emergency hospital attendances with gallstone complications (median 4 vs. 1; p<0.001). Logistic regression showed each prior emergency attendance was associated with 4.6-fold odds of transfusion (p=0.019). Receiver operating characteristic curve analysis showed an area under the curve of 0.92. Three or more attendances predicted need for transfusion with 60.0% sensitivity and 98.0% specificity. Seventy-four percent had at least one G&S sample taken pre-operatively, costing the trust approximately £3,800 per year in materials. Conclusions Pre-operative G&S testing prior to cholecystectomy may not be routinely required. Increased frequency of prior emergency hospital attendances with gallstone complications and co-morbidities associated with coagulopathies were pre-operative risk factors for post-operative blood transfusion. More selective testing could provide large financial savings for health institutions without compromising patient safety.","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"6 8","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140739461","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}
Pub Date : 2024-04-04DOI: 10.3310/nihropenres.13548.1
S. Rees, Andrew Cooklin, Callum Duncan, Manjit Matharu, Seyran Naghdi, Martin Underwood, H. Mistry
Background Chronic migraine is a disabling condition that can substantially impact on quality of life. People with chronic migraine have headaches on at least 15 days of every month. Preventative medications aiming to reduce number of days with migraine are available, but high-quality randomised evidence is lacking for many drugs, and it is unclear which medications should be prioritised for research. There is also no existing evidence about patient and clinicians’ priorities for research. Methods We undertook a consensus workshop with patient and healthcare professional stakeholders, using nominal group technique, to understand these stakeholders’ priorities for future randomised controlled trials. We reached a consensus on a set of research recommendations for the field. Results Eight people with chronic migraine and eleven healthcare professionals took part in an online workshop. Comparisons of calcitonin gene-related peptide monoclonal antibodies (CGRP MAbs) and OnabotulinumtoxinA (BTA) were a top priority for our group. Candesartan and Flunarizine were the top drugs the group wanted to compare against placebo. Conclusions These research recommendations should guide researchers in the field, and funders when prioritising commissioned research and assessing funding applications. Particular areas to explore further are Candesartan or Flunarizine versus placebo, and comparing and combining CGRP MAbs with other medications.
{"title":"Research priorities for randomised controlled trials in chronic migraine preventive medication: A stakeholder consensus workshop","authors":"S. Rees, Andrew Cooklin, Callum Duncan, Manjit Matharu, Seyran Naghdi, Martin Underwood, H. Mistry","doi":"10.3310/nihropenres.13548.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13548.1","url":null,"abstract":"Background Chronic migraine is a disabling condition that can substantially impact on quality of life. People with chronic migraine have headaches on at least 15 days of every month. Preventative medications aiming to reduce number of days with migraine are available, but high-quality randomised evidence is lacking for many drugs, and it is unclear which medications should be prioritised for research. There is also no existing evidence about patient and clinicians’ priorities for research. Methods We undertook a consensus workshop with patient and healthcare professional stakeholders, using nominal group technique, to understand these stakeholders’ priorities for future randomised controlled trials. We reached a consensus on a set of research recommendations for the field. Results Eight people with chronic migraine and eleven healthcare professionals took part in an online workshop. Comparisons of calcitonin gene-related peptide monoclonal antibodies (CGRP MAbs) and OnabotulinumtoxinA (BTA) were a top priority for our group. Candesartan and Flunarizine were the top drugs the group wanted to compare against placebo. Conclusions These research recommendations should guide researchers in the field, and funders when prioritising commissioned research and assessing funding applications. Particular areas to explore further are Candesartan or Flunarizine versus placebo, and comparing and combining CGRP MAbs with other medications.","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"22 6","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140741571","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}
Pub Date : 2024-04-03DOI: 10.3310/nihropenres.13575.1
Michele Siciliano, Sarah Bathers, Ida Bentley, L. Bullock, Andrea Cherrington, Emma M Clark, Jane Fleming, Clare Jinks, Sarah Lewis, Christian Mallen, Elaine Nicholls, Terence W O'Neill, Jo Smith, David Webb, Z. Paskins, Cynthia P Iglesias-Urrutia
Background Digital health interventions (DHI) are associated with significant promise. In recent years, the need to assess the value of these healthcare technologies has motivated a debate regarding the suitability of existing economic evaluation methods in the context of DHI evaluation. Some have argued that robust economic evaluation methods may not be capable of capturing relevant DHI’s characteristics. Others consider that assessing the value of DHI might not be feasible. This protocol paper challenges that view. More specifically, it describes early Health Technology Assessments (HTA) methods to rigorously assess the value for money of a complex intervention including a digital decision support tool i.e., Improving uptake of Fracture Prevention drug treatments (iFraP) as a tracer intervention. iFraP is a complex intervention consisting of a computerised decision support tool, a clinician training package, and information resources to facilitate shared decision-making, increase informed medicine initiation and reduce levels of medicine discontinuation. iFraP’s development was motivated by a view that good quality shared decision-making conversations have the potential to improve levels of osteoporosis medicine uptake. Methods An early economic evaluation of the iFraP intervention was designed to identify, measure, and evaluate the costs and health benefits of iFraP compared to usual practice in Fracture Liaison Services (FLSs). A within-trial cost-effectiveness from the perspective of the National Health Service and Personal Social Service in England will be conducted using patient’s self-reported health related quality of life (HRQoL) and resource use from the iFraP randomised controlled trial. Microanalysis will be used to estimate iFraP’s intervention cost. Finally, Bayesian Value of Information analysis will allow us to estimate an upper bound for the potential health benefits gained from reducing uncertainty on the impact of the iFraP intervention to support uptake and adherence with osteoporosis medicines. Trial registration ISRCTN10606407 - https://doi.org/10.1186/ISRCTN10606407
{"title":"Protocol for a trial-based economic evaluation analysis of a complex digital health intervention including a computerised decision support tool: the iFraP intervention","authors":"Michele Siciliano, Sarah Bathers, Ida Bentley, L. Bullock, Andrea Cherrington, Emma M Clark, Jane Fleming, Clare Jinks, Sarah Lewis, Christian Mallen, Elaine Nicholls, Terence W O'Neill, Jo Smith, David Webb, Z. Paskins, Cynthia P Iglesias-Urrutia","doi":"10.3310/nihropenres.13575.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13575.1","url":null,"abstract":"Background Digital health interventions (DHI) are associated with significant promise. In recent years, the need to assess the value of these healthcare technologies has motivated a debate regarding the suitability of existing economic evaluation methods in the context of DHI evaluation. Some have argued that robust economic evaluation methods may not be capable of capturing relevant DHI’s characteristics. Others consider that assessing the value of DHI might not be feasible. This protocol paper challenges that view. More specifically, it describes early Health Technology Assessments (HTA) methods to rigorously assess the value for money of a complex intervention including a digital decision support tool i.e., Improving uptake of Fracture Prevention drug treatments (iFraP) as a tracer intervention. iFraP is a complex intervention consisting of a computerised decision support tool, a clinician training package, and information resources to facilitate shared decision-making, increase informed medicine initiation and reduce levels of medicine discontinuation. iFraP’s development was motivated by a view that good quality shared decision-making conversations have the potential to improve levels of osteoporosis medicine uptake. Methods An early economic evaluation of the iFraP intervention was designed to identify, measure, and evaluate the costs and health benefits of iFraP compared to usual practice in Fracture Liaison Services (FLSs). A within-trial cost-effectiveness from the perspective of the National Health Service and Personal Social Service in England will be conducted using patient’s self-reported health related quality of life (HRQoL) and resource use from the iFraP randomised controlled trial. Microanalysis will be used to estimate iFraP’s intervention cost. Finally, Bayesian Value of Information analysis will allow us to estimate an upper bound for the potential health benefits gained from reducing uncertainty on the impact of the iFraP intervention to support uptake and adherence with osteoporosis medicines. Trial registration ISRCTN10606407 - https://doi.org/10.1186/ISRCTN10606407","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"287 ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140750659","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}
Pub Date : 2024-04-02DOI: 10.3310/nihropenres.13571.1
L. Bullock, Elaine Nicholls, Andrea Cherrington, S. Butler-Walley, Emma M Clark, Jane Fleming, S. Leyland, Ida Bentley, Simon Thomas, Cynthia P Iglesias-Urrutia, David Webb, Jo Smith, Sarah Bathers, Sarah Lewis, Angela Clifford, Michele Siciliano, Joanne Protheroe, Sarah Ryan, J. Lefroy, N. Dale, A. Hawarden, Sarah Connacher, Robert Horne, Terence W O'Neill, Christian D Mallen, Clare Jinks, Z. Paskins
Background Good quality shared decision-making (SDM) conversations involve people with, or at risk of osteoporosis and clinicians collaborating to decide, where appropriate, which evidence-based medicines best fit the person’s life, beliefs, and values. We developed the improving uptake of Fracture Prevention drug treatments (iFraP) intervention comprising a computerised Decision Support Tool (DST), clinician training package and information resources, for use in UK Fracture Liaison Service consultations. Two primary objectives to determine (1) the effect of the iFraP intervention on patient-reported ease in decision-making about osteoporosis medicines, and (2) cost-effectiveness of iFraP intervention compared to usual NHS care. Secondary objectives are to determine the iFraP intervention effect on patient reported outcome and experience measures, clinical effectiveness (osteoporosis medicine adherence), and to explore intervention acceptability, mechanisms, and processes underlying observed effects, and intervention implementation. Methods The iFraP trial is a pragmatic, parallel-group, individual randomised controlled trial in patients referred to a Fracture Liaison Service, with nested mixed methods process evaluation and health economic analysis. Participants aged ≥50 years (n=380) are randomised (1:1 ratio) to one of two arms: (1) iFraP intervention (iFraP-i) or (2) comparator usual NHS care (iFraP-u) and are followed up at 2-weeks and 3-months. The primary outcome is ease of decision-making assessed 2 weeks after the consultation using the Decisional Conflict Scale (DCS). The primary objectives will be addressed by comparing the mean DCS score in each trial arm (using analysis of covariance) for patients given an osteoporosis medicine recommendation, alongside a within-trial cost-effectiveness and value of information (VoI) analysis. Process evaluation data collection includes consultation recordings, semi-structured interviews, and DST analytics. Discussion The iFraP trial will answer important questions about the effectiveness of the new ‘iFraP’ osteoporosis DST, coupled with clinician training, on SDM and informed initiation of osteoporosis medicines. Trial registration: ISRCTN 10606407, 21/11/2022 https://doi.org/10.1186/ISRCTN10606407
{"title":"A person-centred consultation intervention to improve shared decision-making about, and uptake of, osteoporosis medicines (iFraP): a pragmatic, parallel-group, individual randomised controlled trial protocol","authors":"L. Bullock, Elaine Nicholls, Andrea Cherrington, S. Butler-Walley, Emma M Clark, Jane Fleming, S. Leyland, Ida Bentley, Simon Thomas, Cynthia P Iglesias-Urrutia, David Webb, Jo Smith, Sarah Bathers, Sarah Lewis, Angela Clifford, Michele Siciliano, Joanne Protheroe, Sarah Ryan, J. Lefroy, N. Dale, A. Hawarden, Sarah Connacher, Robert Horne, Terence W O'Neill, Christian D Mallen, Clare Jinks, Z. Paskins","doi":"10.3310/nihropenres.13571.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13571.1","url":null,"abstract":"Background Good quality shared decision-making (SDM) conversations involve people with, or at risk of osteoporosis and clinicians collaborating to decide, where appropriate, which evidence-based medicines best fit the person’s life, beliefs, and values. We developed the improving uptake of Fracture Prevention drug treatments (iFraP) intervention comprising a computerised Decision Support Tool (DST), clinician training package and information resources, for use in UK Fracture Liaison Service consultations. Two primary objectives to determine (1) the effect of the iFraP intervention on patient-reported ease in decision-making about osteoporosis medicines, and (2) cost-effectiveness of iFraP intervention compared to usual NHS care. Secondary objectives are to determine the iFraP intervention effect on patient reported outcome and experience measures, clinical effectiveness (osteoporosis medicine adherence), and to explore intervention acceptability, mechanisms, and processes underlying observed effects, and intervention implementation. Methods The iFraP trial is a pragmatic, parallel-group, individual randomised controlled trial in patients referred to a Fracture Liaison Service, with nested mixed methods process evaluation and health economic analysis. Participants aged ≥50 years (n=380) are randomised (1:1 ratio) to one of two arms: (1) iFraP intervention (iFraP-i) or (2) comparator usual NHS care (iFraP-u) and are followed up at 2-weeks and 3-months. The primary outcome is ease of decision-making assessed 2 weeks after the consultation using the Decisional Conflict Scale (DCS). The primary objectives will be addressed by comparing the mean DCS score in each trial arm (using analysis of covariance) for patients given an osteoporosis medicine recommendation, alongside a within-trial cost-effectiveness and value of information (VoI) analysis. Process evaluation data collection includes consultation recordings, semi-structured interviews, and DST analytics. Discussion The iFraP trial will answer important questions about the effectiveness of the new ‘iFraP’ osteoporosis DST, coupled with clinician training, on SDM and informed initiation of osteoporosis medicines. Trial registration: ISRCTN 10606407, 21/11/2022 https://doi.org/10.1186/ISRCTN10606407","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":"43 14","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140751995","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}
Pub Date : 2024-03-25DOI: 10.3310/nihropenres.13563.1
S. Ijaz, James Nobles, Loubaba Mamluk, Sarah Dawson, Bonnie Curran, Rachael Pryor, Sabi Redwood, Jelena Savović
Background Disciplinary behaviour management strategies are implemented in schools to manage pupil behaviour. There is limited evidence of their intended impact on behaviour but there is growing concern around the potential negative impacts on pupil wellbeing. Methods We carried out a systematic review to examine the impact of these strategies on psychosocial outcomes in pupils (PROSPERO Registration: CRD42021285427). We searched multiple sources and double-screened titles, abstracts, and full texts. Data extraction and risk of bias assessment were done by one reviewer and checked by another. Results were narratively synthesised. Results We included 14 studies, from 5375 citations, assessing temporary suspension (n=10), verbal reprimand (n=2), and mixed strategies (n=2). Depression was the most common outcome (n=7), followed by academic grades (n=4) and behaviour in class (n=4). All except one study were at high risk of bias. We found a recurring pattern in the evidence of disciplinary strategies associated with poor mental wellbeing and behaviour in pupils. The effect on academic attainment was unclear. Conclusions Disciplinary behaviour management strategies may have negative impact on pupil mental wellbeing and class behaviour. These important consequences should be assessed in better designed studies before these strategies are implemented.
{"title":"Disciplinary behaviour management strategies in schools and their impact on student psychosocial outcomes: A systematic review","authors":"S. Ijaz, James Nobles, Loubaba Mamluk, Sarah Dawson, Bonnie Curran, Rachael Pryor, Sabi Redwood, Jelena Savović","doi":"10.3310/nihropenres.13563.1","DOIUrl":"https://doi.org/10.3310/nihropenres.13563.1","url":null,"abstract":"Background Disciplinary behaviour management strategies are implemented in schools to manage pupil behaviour. There is limited evidence of their intended impact on behaviour but there is growing concern around the potential negative impacts on pupil wellbeing. Methods We carried out a systematic review to examine the impact of these strategies on psychosocial outcomes in pupils (PROSPERO Registration: CRD42021285427). We searched multiple sources and double-screened titles, abstracts, and full texts. Data extraction and risk of bias assessment were done by one reviewer and checked by another. Results were narratively synthesised. Results We included 14 studies, from 5375 citations, assessing temporary suspension (n=10), verbal reprimand (n=2), and mixed strategies (n=2). Depression was the most common outcome (n=7), followed by academic grades (n=4) and behaviour in class (n=4). All except one study were at high risk of bias. We found a recurring pattern in the evidence of disciplinary strategies associated with poor mental wellbeing and behaviour in pupils. The effect on academic attainment was unclear. Conclusions Disciplinary behaviour management strategies may have negative impact on pupil mental wellbeing and class behaviour. These important consequences should be assessed in better designed studies before these strategies are implemented.","PeriodicalId":74312,"journal":{"name":"NIHR open research","volume":" 99","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140384643","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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