A novel approach to sharing all available information from funded health research: the NIHR Journals Library

Abstract Background Relevant information on health research must be made publicly available in an accurate, timely and accessible manner if evidence is to inform practice and benefit patient care. Failure to publish research information represents a significant waste of research funds. However, recent studies have demonstrated that non-publication and selective or biased reporting remains a significant problem. The role of online publications in rectifying these issues by providing open access to study information is increasingly recognised. Objective This paper details a novel approach to publishing research information developed by the National Institute for Health Research (NIHR), a major funder of health research in the United Kingdom. The NIHR has enhanced its Journals Library (www.journalslibrary.nihr.ac.uk), providing an online repository of information from research funded through five programmes. We describe how the NIHR Journals Library provides a ‘thread’ of relevant information for each study, including protocols, participant information sheets, data linkages, final reports, publications and diverse knowledge products. We also discuss the Library as a ‘living’ resource, one that is updated as each study progresses from inception to completion. Finally, we consider the implications of the Library for the NIHR, other journals and research teams submitting information. Conclusion Openly publishing information from funded research in the NIHR Journals Library serves as a model of knowledge sharing, maximising return on investment and enhancing the usability and replicability of research findings for different evidence-user communities. The Library also supports wider ‘research on research’ ambitions, enabling users to interrogate the repository of NIHR-funded studies, enhancing the understanding of research commissioning, design, dissemination and impact. Video abstract: www.youtube.com/watch?v=8H03uxN_iTE

Reviewing the case for critical appraisal skills training

Introduction:To review the evolution of critical appraisal skills training alongside the results from a long-term evaluation of a series of research utilisation workshops.Critical appraisal skills training and evidence based health care:The evolution of critical appraisal skills (CAS) training across health care professions is described, showing the centrality of this to evidence based health care and thus clinical effectiveness. The evidence for the effectiveness of CAS training is reviewed.The long-term evaluation of the Foundation of Nursing Studies’ workshops:A postal questionnaire and qualitative interview study of participants and managers were used to evaluate the workshops. These findings were then contextualised through a consultation exercise with senior nurses, practice developers and nurse educators in health care trusts and academic units across the UK.Discussion:The effectiveness of CAS training, its focus and structure is revisited with reference to the literature and the long-term evaluation. Questions concerning the way forward are proposed

The development and implementation of NHS treatment centres as an organisational innovation

The idea for Treatment Centres was first heralded in the NHS Plan (DH, 2000). From a planned small scale introduction of four ‘Diagnostic and Treatment Centres’ (soon renamed as Treatment Centres) in 2001, the plan was to increase the number, range of services and type of provider (with the introduction of the private sector) so that 50 TCs would be operational by 2004/05 (DH,2002). Using the existing Ambulatory Care and Diagnostic Centre at Central Middlesex Hospital (London) and models of surgicentres (developed overseas) as prototypes, the TC model was innovative as it proposed a ‘one-stop shop’ for planned (nonemergency) care. Patients could obtain diagnostic and treatment services under one roof. TCs aimed to reduce inappropriate delays and waiting lists through the separation of elective surgery from emergency and unplanned treatment. By focussing on high volume and routine surgical procedures in orthopaedics, gynaecology, ophthalmology and cardiology, TCs sought to increase efficiency by delivering high volumes of activity and high quality health care using modern methods. This proposed service development was timely for NHS change managers who were seeking ways to make progress towards national waiting time targets and to introduce more patientcentred models of care.Whilst many had not previously considered the TC model, they were eager to explore its advantages at a local level

Evaluating a midwife-led model of antenatal care for women with a previous caesarean section: a retrospective, comparative cohort study

Background: Research is yet to identify effective and safe interventions to increase the vaginal birth after cesarean (VBAC) rate. This research aimed to compare intended and actual VBAC rates before and after implementation of midwife-led antenatal care for women with one previous cesarean birth and no other risk factors in a large, tertiary maternity hospital in England.Methods: This was a retrospective, comparative cohort study. Data were collected from the medical records of women with one previous lower segment cesarean delivery and no other obstetric, medical, or psychological complications who gave birth at the hospital before (2008) and after (2011) the implementation of midwife-led antenatal care. Chi-squared analysis was used to calculate the odds ratio, and logistic regression to account for confounders.Results: Intended and actual VBAC rates were higher in 2011 compared with 2008: 90 percent vs. 77 percent, adjusted odds ratio (aOR) 2.69 (1.48–4.87); and 61 percent vs. 47 percent, aOR 1.79 (1.17–2.75), respectively. Mean rates of unscheduled antenatal care sought via the delivery suite and inpatient admissions were lower in 2011 than 2008. Postnatal maternal and neonatal safety outcomes were similar between the two groups, except mean postnatal length of stay, which was shorter in 2011 compared with 2008 (2.67 vs. 3.15 days).Conclusions: Implementation of midwife-led antenatal care for women with one previous cesarean offers a safe and effective alternative to traditional obstetrician-led antenatal care, and is associated with increased rates of intended and actual VBAC

Balancing the skills: the need for an improvement pyramid

Improvements in health services require a range of technical skills, but like all complex organisational tasks they also rely on the personal skills and attitudes of the staff carrying out the changes. That much is axiomatic.1 2 3 Less certain, but surely potentially helpful to front-line staff undertaking improvement initiatives, is ascertaining just what might be the right sets of skills needed for different kinds of improvement tasks in varying circumstances.4 5 6Useful insights into the ways in which a range of organisational circumstances demand such skills were exposed when the Heath Foundation, an independent charity working to improve healthcare quality in the UK, funded our project to help local ‘improvement groups’ learn how to bring about specifically agreed developments, while simultaneously observing how the improvements worked out. By formatively evaluating the processes involved, the intention was to help the Health Foundation promulgate improvement skills more effectively in future. The methods that we used are briefly summarised in box and have been published fully elsewhere along with the details of the sites, participants, processes and outcomes.7 In brief, two National Health Service (NHS) sites were chosen for being exceptionally well primed, due to their apparent excellence in continual quality improvement, to benefit from extra funding, facilitation and expertise aimed at helping them make better use of ‘improvement science’.8 The expectation was that the focus would be on technical skills (such as rapid improvement cycles, process mapping, tailored outcome measures and data analysis), which would be made available as needed through the Health Foundation’s extensive network of improvement experts

Collective knowledge brokering: The model and impact of an embedded team

Background: The Bristol Knowledge Mobilisation (KM) Team was an unusual collective brokering model, consisting of a multi-professional team of four managers and three academics embedded in both local healthcare policymaking (aka commissioning) and academic primary care.Aims and objectives: They aimed to encourage ‘research-informed commissioning’ and ‘commissioning-informed research’. This paper covers context, structure, processes, advantages, challenges and impact.Methods: Data sources from brokers included personal logs, reflective essays, exit interviews and a team workshop. These were analysed inductively using constant comparison. To obtain critical distance, three external evaluations were conducted, using interviews, observations and documentation.Findings: Stable, solvent organisations; senior involvement with good inter-professional relationships; secure funding; and networks of engaged allies in host organisations supported the brokers. Essential elements were two-way embedding, ‘buddying up’, team leadership, brokers’ interpersonal skills, and two-year, part-time contracts. By working collectively, the brokers fostered cross-community interactions and modelled collaborative behaviour, drawing on each other’s ‘insider’ knowledge, networks and experience. Challenges included too many taskmasters, unrealistic expectations and work overload. However, team-brokering provided a safe space to be vulnerable, share learning, and build confidence. As host organisations benefitted most from embedded brokers, both communities noted changes in attitude, knowledge, skills and confidence. The team were more successful in fostering ‘commissioning-informed research’ with co-produced research grants than ‘research-informed commissioning’.Discussion and conclusions: Although still difficult, the collective support and comradery of an embedded, two-way, multi-professional team made encouraging interactions, and therefore brokering, easier. A team approach modelled collaborative behaviour and created a critical mass to affect cultural change

An open letter to the BMJ editors on qualitative research

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Long-term safety and efficacy of patisiran for hereditary transthyretin-mediated amyloidosis with polyneuropathy: 12-month results of an open-label extension study

© 2020 Elsevier Ltd. All rights reserved.Background: Hereditary transthyretin-mediated amyloidosis is a rare, inherited, progressive disease caused by mutations in the transthyretin (TTR) gene. We assessed the safety and efficacy of long-term treatment with patisiran, an RNA interference therapeutic that inhibits TTR production, in patients with hereditary transthyretin-mediated amyloidosis with polyneuropathy. Methods: This multicentre, open-label extension (OLE) trial enrolled patients at 43 hospitals or clinical centres in 19 countries as of Sept 24, 2018. Patients were eligible if they had completed the phase 3 APOLLO or phase 2 OLE parent studies and tolerated the study drug. Eligible patients from APOLLO (patisiran and placebo groups) and the phase 2 OLE (patisiran group) studies enrolled in this global OLE trial and received patisiran 0·3 mg/kg by intravenous infusion every 3 weeks with plans to continue to do so for up to 5 years. Efficacy assessments included measures of polyneuropathy (modified Neuropathy Impairment Score +7 [mNIS+7]), quality of life, autonomic symptoms, nutritional status, disability, ambulation status, motor function, and cardiac stress, with analysis by study groups (APOLLO-placebo, APOLLO-patisiran, phase 2 OLE patisiran) based on allocation in the parent trial. The global OLE is ongoing with no new enrolment, and current findings are based on the interim analysis of the patients who had completed 12-month efficacy assessments as of the data cutoff. Safety analyses included all patients who received one or more dose of patisiran up to the data cutoff. This study is registered with ClinicalTrials.gov, NCT02510261. Findings: Between July 13, 2015, and Aug 21, 2017, of 212 eligible patients, 211 were enrolled: 137 patients from the APOLLO-patisiran group, 49 from the APOLLO-placebo group, and 25 from the phase 2 OLE patisiran group. At the data cutoff on Sept 24, 2018, 126 (92%) of 137 patients from the APOLLO-patisiran group, 38 (78%) of 49 from the APOLLO-placebo group, and 25 (100%) of 25 from the phase 2 OLE patisiran group had completed 12-month assessments. At 12 months, improvements in mNIS+7 with patisiran were sustained from parent study baseline with treatment in the global OLE (APOLLO-patisiran mean change -4·0, 95 % CI -7·7 to -0·3; phase 2 OLE patisiran -4·7, -11·9 to 2·4). Mean mNIS+7 score improved from global OLE enrolment in the APOLLO-placebo group (mean change from global OLE enrolment -1·4, 95% CI -6·2 to 3·5). Overall, 204 (97%) of 211 patients reported adverse events, 82 (39%) reported serious adverse events, and there were 23 (11%) deaths. Serious adverse events were more frequent in the APOLLO-placebo group (28 [57%] of 49) than in the APOLLO-patisiran (48 [35%] of 137) or phase 2 OLE patisiran (six [24%] of 25) groups. The most common treatment-related adverse event was mild or moderate infusion-related reactions. The frequency of deaths in the global OLE was higher in the APOLLO-placebo group (13 [27%] of 49), who had a higher disease burden than the APOLLO-patisiran (ten [7%] of 137) and phase 2 OLE patisiran (0 of 25) groups. Interpretation: In this interim 12-month analysis of the ongoing global OLE study, patisiran appeared to maintain efficacy with an acceptable safety profile in patients with hereditary transthyretin-mediated amyloidosis with polyneuropathy. Continued long-term follow-up will be important for the overall assessment of safety and efficacy with patisiran.info:eu-repo/semantics/publishedVersio