Publications by authors named "Mike Clarke"

343 Publications

Strengthening prehospital clinical practice guideline development in South Africa: Reflections from guideline experts.

Afr J Emerg Med 2021 Mar 29;11(1):132-139. Epub 2020 Oct 29.

Centre for Evidence-based Health Care, Division of Epidemiology and Biostatistics, Department of Global Health, Stellenbosch University, South Africa.

Introduction: (new) guideline development methods are well described and supported by numerous examples, including comprehensive checklists. However, alternative guideline development methods, which draw from existing up to date, high quality clinical practice guidelines instead of re-inventing the wheel, have not been adopted so readily, despite the potential efficiencies of such methods compared to development. In Africa, guideline quality and rigour of development, especially for prehospital care, remains poor. This paper firstly describes the opinions of international guideline experts on the African Federation for Emergency Medicine guideline project, and secondly updates a framework for South African prehospital guideline development.

Methods: We conducted a qualitative study of expert reviews of an evidence-based guideline development project led by the African Federation for Emergency Medicine in 2016 for prehospital care in South Africa. We purposefully sampled key international and regional guideline experts from a range of organisations. Comments and voice memos, following a terms of reference guide, were thematically analysed through manual coding.

Results: A total of seven experts gave feedback. Key themes revolved around existing international clinical practice guidelines not being enough to cover context specific evidence, blurring of guideline responsibilities and output, and transparency of guideline decisions and conflicts of interest. We showcase three fit-for-purpose guideline development approaches and provide an updated alternative guideline development roadmap for low-resource settings.

Conclusion: In order to create clinical practice guidelines that clinicians trust and use on a daily basis to change lives, guideline developers need rigorous yet pragmatic approaches that are responsive to end-user needs. Reflecting on the African Federation for Emergency Medicine prehospital guideline development project in 2016, this paper presents key guiding themes to strengthen guideline development in low- and middle-income countries and other low-resource settings and provides an updated hybrid guideline development approach.
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http://dx.doi.org/10.1016/j.afjem.2020.09.010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7910183PMC
March 2021

A Neurodisparity Index of Nationwide Access to Neurological Health Care in Northern Ireland.

Front Neurol 2021 12;12:608070. Epub 2021 Feb 12.

Department of Neurology, Altnagelvin Hospital, Derry, Ireland.

Nationwide disparities in managing neurological patients have rarely been reported. We compared neurological health care between the population who reside in a Health and Social Care Trust with a tertiary neuroscience center and those living in the four non-tertiary center Trusts in Northern Ireland. Using the tertiary center Trust population as reference, neurodisparity indices (NDIs) defined as the number of treated patients resident in each Trust per 100,000 residents compared to the same ratio in the tertiary center Trust for a fixed time period. NDIs were calculated for four neurological pathways-intravenous thrombolysis (iv-tPA) and mechanical thrombectomy (MT) for acute ischemic stroke (AIS), disease modifying treatment (DMT) in multiple sclerosis (MS) and admissions to a tertiary neurology ward. Neurological management was recorded in 3,026 patients. Patients resident in the tertiary center Trust were more likely to receive AIS treatments (iv-tPA and MT) and access to the neurology ward ( < 0.001) than patients residing in other Trusts. DMT use for patients with MS was higher in two non-tertiary center Trusts than in the tertiary center Trust. There was a geographical gradient for MT for AIS patients and ward admissions. Averaged NDIs for non-tertiary center Trusts were: 0.48 (95%CI 0.32-0.71) for patient admissions to the tertiary neurology ward, 0.50 (95%CI 0.38-0.66) for MT in AIS patients, 0.78 (95%CI 0.67-0.92) for iv-tPA in AIS patients, and 1.11 (95%CI 0.99-1.26) for DMT use in MS patients. There are important neurodisparities in Northern Ireland, particularly for MT and tertiary ward admissions. Neurologists and health service planners should be aware that geography and time-dependent management of neurological patients worsen neurodisparities.
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http://dx.doi.org/10.3389/fneur.2021.608070DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7907594PMC
February 2021

The effectiveness of different patient referral systems to shorten waiting times for elective surgeries: systematic review.

BMC Health Serv Res 2021 Feb 17;21(1):155. Epub 2021 Feb 17.

Center for Public Health, School of Medicine Dentistry and Biomedical Sciences, Queen's University Belfast, Institute of Clinical Science Block A, Royal Victoria Hospital, Grosvenor Road, Belfast, BT12 6BA, UK.

Background: Long waiting times for elective surgery are common to many publicly funded health systems. Inefficiencies in referral systems in high-income countries are more pronounced than lower and middle-income countries. Primary care practitioners play a major role in determining which patients are referred to surgeon and might represent an opportunity to improve this situation. With conventional methods of referrals, surgery clinics are often overcrowded with non-surgical referrals and surgical patients experience longer waiting times as a consequence. Improving the quality of referral communications should lead to more timely access and better cost-effectiveness for elective surgical care. This review summarises the research evidence for effective interventions within the scope of primary-care referral methods in the surgical care pathway that might shorten waiting time for elective surgeries.

Methods: We searched PubMed, EMBASE, SCOPUS, Web of Science and Cochrane Library databases in December-2019 to January-2020, for articles published after 2013. Eligibility criteria included major elective surgery lists of adult patients, excluding cancer related surgeries. Both randomised and non-randomised controlled studies were eligible. The quality of evidence was assessed using ROBINS-I, AMSTAR 2 and CASP, as appropriate to the study method used. The review presentation was limited to a narrative synthesis because of heterogeneity. The PROSPERO registration number is CRD42019158455.

Results: The electronic search yielded 7543 records. Finally, nine articles were considered as eligible after deduplication and full article screening. The eligible research varied widely in design, scope, reported outcomes and overall quality, with one randomised trial, two quasi-experimental studies, two longitudinal follow up studies, three systematic reviews and one observational study. All the six original articles were based on referral methods in high-income countries. The included research showed that patient triage and prioritisation at the referral stage improved timely access and increased the number of consultations of surgical patients in clinics.

Conclusions: The available studies included a variety of interventions and were of medium to high quality researches. Managing patient referrals with proper triaging and prioritisation using structured referral formats is likely to be effective in health systems to shorten the waiting times for elective surgeries, specifically in high-income countries.
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http://dx.doi.org/10.1186/s12913-021-06140-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7887721PMC
February 2021

New psychoactives within polydrug use trajectories-evidence from a mixed-method longitudinal study.

Addiction 2021 Jan 28. Epub 2021 Jan 28.

Centre for Evidence and Social Innovation, Queen's University Belfast, Belfast, UK.

Aims: To provide public health-related research evidence on types and usage patterns of new psychoactive substances (NPS), developmental pathways into NPS and decision-making factors for, and associated harms of, NPS use.

Design: Three-phase mixed-methods design, including a latent class analysis (LCA) of the longitudinal Belfast Youth Development Study (BYDS), a narrative analysis of interviews with NPS users and a three-step approach manual method modelling using regressions to reveal classes of substance use and their associated predictors and outcomes.

Setting: Northern Ireland.

Participants: A total of 2039 people who responded to the questions on 'ever use' of the drug variables included at wave 7 (aged 21 years) of the BYDS. Eighty-four narrative interviews with NPS users.

Measurements: Categories of drug use identified by LCA. Predictors and outcomes included measures of family, partners, peers, substance use, school, delinquency and mental health.

Findings: A four-class solution provided the best fit for the data: alcohol; alcohol and tobacco; alcohol, tobacco and cannabis; and polydrug (the latter including NPS). The qualitative analysis yielded a taxonomy that distinguished how NPS operate within a wider range of drug repertoires from experimental to problematic.

Conclusions: In Northern Ireland, new psychoactive substances appear to be a feature of broader polydrug use rather than a standalone class of drug use.
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http://dx.doi.org/10.1111/add.15422DOI Listing
January 2021

Opinion and practice survey about the use of prognostic models in acute pulmonary embolism.

Thromb Res 2021 Feb 1;198:40-48. Epub 2020 Nov 1.

Department for Continuing Education Professional Development, University of Oxford, Oxford, United Kingdom; Northern Ireland Network for Trials Methodology Research, Queen's University Belfast, Belfast, United Kingdom.

Introduction: Methods for prognosis assessment and patient management in acute pulmonary embolism (PE) are much debated among physicians. We conducted an online survey to determine physician's attitudes and barriers towards the use of prognostic models when treating patients with acute PE.

Method: Physicians members of the French and the European scientific societies for emergency medicine or of a French thrombosis research network were reached by their respective scientific societies and invited to participate via email. The questionnaire was a mixture of close-ended with yes-no or multiple-choice options and a small number of open-ended questions.

Results: The survey included 461 respondents. The most commonly used prognostic tools were clinical judgment (36%) and prognostic models (29.5%). Prognostic models were used by 57% of respondents in more than half of all cases and prognostic indicators by 62% in addition to prognostic models. Affiliation group and type of hospital emerged as independent predictors for choosing prognostic models. Many (52%) reported lack of familiarity with the models and reported clinical judgment (60%) or hospital checklists (73%) as being as good as or better than prognostic models. The highest acceptable 30-day mortality rate limit for early discharge or outpatient management was deemed to be 1%, but few patients are discharged early or completely managed on an outpatient basis.

Conclusions: This survey provides new information for implementing knowledge translation strategies to improve prognostic risk assessment for acute PE patients, and highlights the need for considering the use of clinical judgment and hospital checklists in future clinical research.
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http://dx.doi.org/10.1016/j.thromres.2020.10.027DOI Listing
February 2021

Nurse-led advance care planning with older people who have end-stage kidney disease: feasibility of a deferred entry randomised controlled trial incorporating an economic evaluation and mixed methods process evaluation (ACReDiT).

BMC Nephrol 2020 11 13;21(1):478. Epub 2020 Nov 13.

School of Nursing and Midwifery, Queen's University Belfast, Medical Biology Centre, 97 Lisburn Road, Belfast, BT9 7BL, UK.

Background: Advance Care Planning is recommended for people with end-stage kidney disease but evidence is limited. Robust clinical trials are needed to investigate the impact of advance care planning in this population. There is little available data on cost-effectiveness to guide decision makers in allocating resources for advance care planning. Therefore we sought to determine the feasibility of a randomised controlled trial and to test methods for assessing cost-effectiveness.

Methods: A deferred entry, randomised controlled feasibility trial, incorporating economic and process evaluations, with people with end-stage kidney disease, aged 65 years or older, receiving haemodialysis, in two renal haemodialysis units in Northern Ireland, UK. A nurse facilitator helped the patient make an advance care plan identifying: a surrogate decision-maker; what the participant would like to happen in the future; any advance decision to refuse treatment; preferred place of care at end-of-life.

Results: Recruitment lasted 189 days; intervention and data collection 443 days. Of the 67 patients invited to participate 30 (45%) declined and 36 were randomised to immediate or deferred advance care plan groups. Twenty-two (61%) made an advance care plan and completed data collection at 12 weeks; 17 (47.2%) were able to identify a surrogate willing to be named in the advance care plan document. The intervention was well-received and encouraged end-of-life conversations, but did not succeed in helping patients to fully clarify their values or consider specific treatment choices. There was no significant difference in health system costs between the immediate and deferred groups.

Conclusions: A trial of advance care planning with participants receiving haemodialysis is feasible and acceptable to patients, but challenging. A full trial would require a pool of potential participants five times larger than the number required to complete data collection at 3 months. Widening eligibility criteria to include younger (under 65 years of age) and less frail patients, together with special efforts to engage and retain surrogates may improve recruitment and retention. Traditional advance care planning outcomes may need to be supplemented with those that are defined by patients, helping them to participate with clinicians in making medical decisions.

Trial Registration: Registered December 16, 2015. ClinicalTrials.gov Identifier: NCT02631200 .
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http://dx.doi.org/10.1186/s12882-020-02129-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7663906PMC
November 2020

Clinical Practice Guidelines and Experts' Consensuses for Treatment of Coronavirus Disease 2019 (COVID-19) Patients with Chinese Herbal Medicine: A Systematic Review.

Chin J Integr Med 2020 Oct 8;26(10):786-793. Epub 2020 Oct 8.

Northern Ireland Clinical Trials Unit and Methodology Hub, Centre for Public Health, Queen's University Belfast, Belfast, UK.

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http://dx.doi.org/10.1007/s11655-020-3431-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7543674PMC
October 2020

A systematic review finds Core Outcome Set uptake varies widely across different areas of health.

J Clin Epidemiol 2021 Jan 26;129:114-123. Epub 2020 Sep 26.

MRC North West Hub for Trials Methodology Research, Department of Health Data Science, University of Liverpool, Block F Waterhouse Building, 1-5 Brownlow Street, Liverpool L69 3GL, United Kingdom.

Objective: The aim of our review was to bring together studies that had assessed the uptake of core outcome sets (COS) to explore the level of uptake across different COS and areas of health.

Study Design And Setting: We examined the citations of 337 COS reports to identify studies that had assessed the uptake of a particular COS in randomized controlled trials (RCTs) or systematic reviews (SRs).

Results: We identified 24 studies that had assessed uptake in RCTs and two studies that had assessed uptake in SRs. The studies covered a total of 17/337 (5%) COS. Uptake rates reported for RCTs varied from 0% of RCTs (gout) to 82% RCTs (rheumatoid arthritis) measuring the full COS. Studies that assessed uptake of individual core outcomes showed a wide variation in uptake between the outcomes. Suggested barriers to uptake included lack of validated measures, lack of patient and other key stakeholder involvement in COS development, and lack of awareness of the COS.

Conclusions: Few studies have been undertaken to assess the uptake of COS in RCTs and SRs. Further studies are needed to assess whether COS have been implemented across a wider range of disease categories and to explore the barriers and facilitators to COS uptake.
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http://dx.doi.org/10.1016/j.jclinepi.2020.09.029DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7815247PMC
January 2021

Evidence-Based Research Series-Paper 2 : Using an Evidence-Based Research approach before a new study is conducted to ensure value.

J Clin Epidemiol 2021 Jan 26;129:158-166. Epub 2020 Sep 26.

Johns Hopkins University School of Medicine, Baltimore, MD.

Background And Objectives: There is considerable actual and potential waste in research. The aim of this article is to describe how using an evidence-based research approach before conducting a study helps to ensure that the new study truly adds value.

Study Design And Setting: Evidence-based research is the use of prior research in a systematic and transparent way to inform a new study so that it is answering questions that matter in a valid, efficient, and accessible manner. In this second article of the evidence-based research series, we describe how to apply an evidence-based research approach before starting a new study.

Results: Before a new study is performed, researchers need to provide a solid justification for it using the available scientific knowledge as well as the perspectives of end users. The key method for both is to conduct a systematic review of earlier relevant studies.

Conclusion: Describing the ideal process illuminates the challenges and opportunities offered through the suggested evidence-based research approach. A systematic and transparent approach is needed to provide justification for and to optimally design a relevant and necessary new study.
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http://dx.doi.org/10.1016/j.jclinepi.2020.07.019DOI Listing
January 2021

Evidence-Based Research Series-Paper 3: Using an Evidence-Based Research approach to place your results into context after the study is performed to ensure usefulness of the conclusion.

J Clin Epidemiol 2021 Jan 23;129:167-171. Epub 2020 Sep 23.

Johns Hopkins Evidence-based Practice Center, Division of General Internal Medicine, Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.

Background And Objective: There is considerable actual and potential waste in research. Using evidence-based research (EBR) can ensure the value of a new study. The aim of this article, the third in a series, is to describe an EBR approach to putting research results into context.

Study Design And Setting: EBR is the use of prior research in a systematic and transparent way to inform a new study so that it is answering questions that matter in a valid, efficient, and accessible manner. In this third and final article of a series, we describe how to use the context of existing evidence to reach and present a trustworthy and useful conclusion when reporting results from a new clinical study.

Results: We describe a method, the EBR approach, that by using a systematic and transparent consideration of earlier similar studies when interpreting and presenting results from a new original study will ensure usefulness of the conclusion.

Conclusion: Using an EBR approach will improve the usefulness of a clinical study by providing the context to draw more valid conclusions and explicit information about new research needs.
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http://dx.doi.org/10.1016/j.jclinepi.2020.07.021DOI Listing
January 2021

Assessing the relevance and uptake of core outcome sets (an agreed minimum collection of outcomes to measure in research studies) in Cochrane systematic reviews: a review.

BMJ Open 2020 09 6;10(9):e036562. Epub 2020 Sep 6.

Center for Evidence-based Healthcare, Medizinische Fakultät, Technische Universität Dresden, Dresden, Germany.

Objectives: A core outcome set (COS) is an agreed standardised minimum collection of outcomes that should be measured and reported in research in a specific area of health. Cochrane systematic reviews ('reviews') are rigorous reviews on health-related topics conducted under the auspices of Cochrane. This study examines the use of existing COS to inform the choice of outcomes in Cochrane systematic reviews ('reviews') and investigates the views of the coordinating editors of Cochrane Review Groups (CRGs) on this topic.

Methods: A cohort of 100 recently published or updated Cochrane reviews were assessed for reference to a COS being used to inform the choice of outcomes for the review. Existing COS, published 2 or more years before the review publication, were then identified to assess how often a reviewer could have used a relevant COS if it was available. We asked 52 CRG coordinating editors about their involvement in COS development, how outcomes are selected for reviews in their CRG and their views of the advantages and challenges surrounding the standardisation of outcomes within their CRG.

Results: In the cohort of reviews from 2019, 40% (40/100) of reviewers noted problems due to outcome inconsistency across the included studies. In 7% (7/100) of reviews, a COS was referenced in relation to the choice of outcomes for the review. Relevant existing COS could be considered for a review update in 35% of the others (33/93). Most editors who responded (31/36, 86%) thought that COS should definitely or possibly be used to inform the choice of outcomes in a review.

Conclusions: Systematic reviewers are continuing to note outcome heterogeneity but are starting to use COS to inform their reviews. There is potential for greater uptake of COS in Cochrane reviews.
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http://dx.doi.org/10.1136/bmjopen-2019-036562DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7476465PMC
September 2020

Development and feasibility of a tailored habit-based dietary intervention coupled with natural tooth replacement on the nutritional status of older patients.

Pilot Feasibility Stud 2020 24;6:120. Epub 2020 Aug 24.

Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Institute of Clinical Science Block B, Belfast, BT12 6BJ UK.

Background: Older adults suffering partial tooth loss may need additional intervention strategies other than natural tooth replacement alone to improve their nutritional status. This study aimed to design and develop a habit-based tailored dietary intervention and to assess the feasibility and acceptability of the intervention, in conjunction with natural tooth replacement, amongst partially dentate older adults.

Methods: The design and development of the dietary intervention (phase 1) consisted of analysis of the target population's dietary intake and qualitative research through focus groups with community-dwelling older adults (aged 65 years and over). The dietary intervention consisted of forming three healthy dietary habits around fruits and vegetables, wholegrains and healthy proteins. Feasibility of the intervention was then tested amongst older adults who had recently completed dental treatment for natural tooth replacement in a small non-randomised single arm study (phase 2). The principal feasibility outcome was the usability and acceptability of the intervention which was measured using evaluation questionnaires and by conducting post-intervention semi-structured interviews. Supporting outcomes consisted of feasibility of screening procedures, recruitment strategies and retention/attrition rates as well as the participant's compliance to the intervention assessed through self-monitoring tracking sheets.

Results: Twenty-one older adults (mean [SD] age 72.1 [10.4].) took part in one of four focus group discussions (phase 1). Twelve themes related to barriers (e.g. oral health, appetite) and facilitators (e.g. nutritional knowledge, retirement) of healthy eating guided intervention development, as did a further five themes when asked for direct intervention feedback. Nine older adult participants (mean [SD] age 72.5[9.7]) were recruited into the feasibility study (phase 2) where eight themes were identified from feedback interview discussions. The principal outcome measures identified intervention feasibility as participants considered the intervention acceptable and useable as both the evaluation questionnaire and qualitative interview results were overwhelmingly positive. As a supporting outcome measure, strong intervention compliance was also achieved. Screening procedures were accepted but additional recruitment strategies (e.g. incorporation of home study visits or recruitment via posters advertisement) may benefit future study enrolment and retention.

Conclusion: Phase 1 and phase 2 findings have allowed for an iterative, user-driven intervention to be developed and refined for a randomised control study to evaluate the intervention's effectiveness.

Trial Registration: ISRCTN66118345.
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http://dx.doi.org/10.1186/s40814-020-00654-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7446197PMC
August 2020

Clinical practice guidelines and experts' consensuses of traditional Chinese herbal medicine for novel coronavirus (COVID-19): protocol of a systematic review.

Syst Rev 2020 08 3;9(1):170. Epub 2020 Aug 3.

School of Health Preservation and Rehabilitation, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.

Background: The World Health Organization declared on March 11, 2020, that the spread of the severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) has escalated from epidemic into pandemic. As the initial outbreak area, China has taken multiple active measures to deal with the epidemic. Updated versions of diagnosis and treatment guideline for novel coronavirus (COVID-19) patients have been issued, and traditional Chinese herbal medicine has been recommended as a treatment. The objective of this study will be to summarize the recommendations in current clinical practice guidelines about the use of traditional Chinese herbal medicine for COVID-19 patients. We will also evaluate and report on the methodological and reporting quality of these guidelines.

Methods: In this systematic review, we will search for guidelines, expert consensuses, and policy documents published since December 2019 in electronic databases (e.g., PubMed, EMBASE, and Chinese databases) and on websites of governments or organizations (e.g., The National Guideline Clearinghouse [NGC], Guidelines International Network [GIN], National Institute for Health and Clinical Excellence (NICE), Scottish Intercollegiate Guidelines Network [SIGN], and WHO). Eligible documents will be independently selected, and relevant data will be independently extracted by two reviewers. We will also independently evaluate the methodological quality and reporting quality of the included guidelines, using the Appraisal of Guidelines for REsearch & Evaluation (AGREE) II tool and Reporting Items for Practice Guidelines in Healthcare (RIGHT) statement, respectively. Any discrepancies will be discussed and resolved through discussion among the reviewers. We will use the extracted information to summarize their recommendations for traditional Chinese herbal formulae and Chinese patent medicine for COVID-19 patients and to summarize the strength and quality of these recommendations with reference to the results of AGREE II and RIGHT tools.

Discussion: This review will summarize the recommendations in current clinical practice guidelines and provide insight into the implementation strategies for traditional Chinese herbal medicine in COVID-19 patients.

Systematic Review Registration: PROSPERO CRD42020179205.
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http://dx.doi.org/10.1186/s13643-020-01432-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7397967PMC
August 2020

Learning from Cochrane systematic reviews: what improvements do these suggest for the design of trials?

F1000Res 2020 11;9:178. Epub 2020 Mar 11.

Health Services Research Unit, University of Aberdeen, Aberdeen, UK.

Many randomised trials have serious methodological flaws that fatally undermine their results, which makes the research wasteful. This is of concern for many, including those doing systematic reviews that include trials. Cochrane systematic reviews have a section called '  ', which allows authors of the review to present their conclusions on how future research might be improved. Looking at these conclusions might highlight priority areas for improvement. We focused on the Cochrane Schizophrenia Review Group and the Multiple sclerosis and rare diseases of the central nervous system Review Group (the MS Review Group).  Reviews with citation dates between 2009 and 2019 were identified and the recommendations of review authors in '   were put into categories. Between 2009 and 2019 we identified 162 reviews for the Schizophrenia Review Group and 43 reviews for the MS Review Group. We created 22 categories of recommendations in total, of which 12 were common to both groups. The five most used categories were the same for both: better choice of outcomes; better choice of intervention/comparator; longer follow-up; larger sample size; use of validated scales.  Better choice of outcomes and/or intervention/comparator was recommended in over 50% of reviews. Longer follow-up and larger sample size were recommended in over a third, with use of validated scales being suggested in around a fifth of reviews. There was no obvious pattern of improvement over time for trials included in systematic reviews published by both groups. We suggest that trialists working in these and other areas ask themselves, or are compelled to do so by others (e.g. funders), why they have chosen their outcomes, intervention and comparator, whether follow-up is long enough, if the sample size is big enough and whether the scales they choose to measure their outcomes are appropriate.
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http://dx.doi.org/10.12688/f1000research.22635.2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7194492PMC
February 2021

Addressing challenges for clinical research responses to emerging epidemics and pandemics: a scoping review.

BMC Med 2020 06 25;18(1):190. Epub 2020 Jun 25.

Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, New Richards Building, Old Road Campus, Oxford, OX3 7LG, UK.

Background: Major infectious disease outbreaks are a constant threat to human health. Clinical research responses to outbreaks generate evidence to improve outcomes and outbreak control. Experiences from previous epidemics have identified multiple challenges to undertaking timely clinical research responses. This scoping review is a systematic appraisal of political, economic, administrative, regulatory, logistical, ethical and social (PEARLES) challenges to clinical research responses to emergency epidemics and solutions identified to address these.

Methods: A scoping review. We searched six databases (MEDLINE, Embase, Global Health, PsycINFO, Scopus and Epistemonikos) for articles published from 2008 to July 2018. We included publications reporting PEARLES challenges to clinical research responses to emerging epidemics and pandemics and solutions identified to address these. Two reviewers screened articles for inclusion, extracted and analysed the data.

Results: Of 2678 articles screened, 76 were included. Most presented data relating to the 2014-2016 Ebola virus outbreak or the H1N1 outbreak in 2009. The articles related to clinical research responses in Africa (n = 37), Europe (n = 8), North America (n = 5), Latin America and the Caribbean (n = 3) and Asia (n = 1) and/or globally (n = 22). A wide range of solutions to PEARLES challenges was presented, including a need to strengthen global collaborations and coordination at all levels and develop pre-approved protocols and equitable frameworks, protocols and standards for emergencies. Clinical trial networks and expedited funding and approvals were some solutions implemented. National ownership and community engagement from the outset were a key enabler for delivery. Despite the wide range of recommended solutions, none had been formally evaluated.

Conclusions: To strengthen global preparedness and response to the COVID-19 pandemic and future epidemics, identified solutions for rapid clinical research deployment, delivery, and dissemination must be implemented. Improvements are urgently needed to strengthen collaborations, funding mechanisms, global and national research capacity and capability, targeting regions vulnerable to epidemics and pandemics. Solutions need to be flexible to allow timely adaptations to context, and research led by governments of affected regions. Research communities globally need to evaluate their activities and incorporate lessons learnt to refine and rehearse collaborative outbreak response plans in between epidemics.
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http://dx.doi.org/10.1186/s12916-020-01624-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7315698PMC
June 2020

Anticipatory care planning for older adults: a trans-jurisdictional feasibility study.

Br J Gen Pract 2020 Jun;70(suppl 1)

Queens University Belfast.

Background: As the population of older adults' increases, the complexity of care required to support those who choose to remain in the community has also increased. Anticipatory Care Planning (ACP) through earlier identification of healthcare needs is evidenced to improve quality of life, decrease the number of aggressive futile interventions, and even to prolong life.

Aim: To determine the feasibility of a cluster randomised trial to evaluate the implementation and outcomes of Anticipatory Care Planning (ACP) in primary care to assist older adults identified as at risk for functional decline by developing a personalised support plan.

Method: GP practices were randomised into control/intervention groups stratified by jurisdiction [Northern Ireland (UK) and the Republic of Ireland (RoI)], and by setting (urban and rural). Participants were included if they were a) aged ≥70 years, b) 2 or more chronic medical conditions, c) 4 or more prescribed medications. The Anticipatory Care Plan consisted of home visits where the study nurse discussed patients' goals and plans. An action plan was put in place following consultation with patient's GPs and study Pharmacist.

Results: Eight primary care practices participated; four in the UK and four in the RoI. Sample = 64. Data was collected pertaining to patient quality of life, mental health, healthcare utilisation, costs, perception of person-centred care, and the use of potentially inappropriate medication.

Conclusion: Unique insights relating to the trans-jurisdictional delivery of healthcare services in the UK and RoI were observed which has implications on service delivery for older adults.
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http://dx.doi.org/10.3399/bjgp20X711197DOI Listing
June 2020

Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration in COVID-19 (REALIST-COVID-19): A structured summary of a study protocol for a randomised, controlled trial.

Trials 2020 Jun 3;21(1):462. Epub 2020 Jun 3.

Wellcome Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Science Queen's University Belfast, Belfast, UK.

Objectives: The primary objective of the study is to assess the safety of a single intravenous infusion of Mesenchymal Stromal Cells (MSCs) in patients with Acute Respiratory Distress Syndrome (ARDS) due to COVID-19. Secondary objectives are to determine the effects of MSCs on important clinical outcomes, as described below.

Trial Design: REALIST COVID 19 is a randomised, placebo-controlled, triple blinded trial.

Participants: The study will be conducted in Intensive Care Units in hospitals across the United Kingdom. Patients with moderate to severe ARDS as defined by the Berlin definition, receiving invasive mechanical ventilation and with a diagnosis of COVID-19 based on clinical diagnosis or PCR test will be eligible. Patients will be excluded for the following reasons: more than 72 hours from the onset of ARDS; age < 16 years; patient known to be pregnant; major trauma in previous 5 days; presence of any active malignancy (other than non-melanoma skin cancer); WHO Class III or IV pulmonary hypertension; venous thromboembolism currently receiving anti-coagulation or within the past 3 months; patient receiving extracorporeal life support; severe chronic liver disease (Child-Pugh > 12); Do Not Attempt Resuscitation order in place; treatment withdrawal imminent within 24 hours; prisoners; declined consent; non-English speaking patients or those who do not adequately understand verbal or written information unless an interpreter is available; previously enrolled in the REALIST trial.

Intervention And Comparator: Intervention: Allogeneic donor CD362 enriched human umbilical cord derived mesenchymal stromal cells (REALIST ORBCEL-C) supplied as sterile, single-use cryopreserved cell suspension of a fixed dose of 400 x10 cells in 40ml volume, to be diluted in Plasma-Lyte 148 to a total volume of 200mls for administration. Comparator (placebo): Plasma-Lyte 148 Solution for Infusion (200mls). The cellular product (REALIST ORBCEL-C) was developed and patented by Orbsen Therapeutics.

Main Outcomes: The primary safety outcome is the incidence of serious adverse events. The primary efficacy outcome is Oxygenation Index (OI) at day 7. Secondary outcomes include: OI at days 4 and 14; respiratory compliance, driving pressure and PaO/FiO ratio (PF ratio) at days 4, 7 and 14; Sequential Organ Failure Assessment (SOFA) score at days 4, 7 and 14; extubation and reintubation; ventilation free days at day 28; duration of mechanical ventilation; length of ICU and hospital stay; 28-day and 90-day mortality.

Randomisation: After obtaining informed consent, patients will be randomised via a centralised automated 24-hour telephone or web-based randomisation system (CHaRT, Centre for Healthcare Randomised Trials, University of Aberdeen). Randomisation will be stratified by recruitment centre and by vasopressor use and patients will be allocated to REALIST ORBCEL-C or placebo control in a 1:1 ratio.

Blinding (masking): The investigator, treating physician, other members of the site research team and participants will be blinded. The cell therapy facility and clinical trials pharmacist will be unblinded to facilitate intervention and placebo preparation. The unblinded individuals will keep the treatment information confidential. The infusion bag will be masked at the time of preparation and will be administered via a masked infusion set.

Numbers To Be Randomised (sample Size): A sample size of 60 patients with 30 patients randomised to the intervention and 30 to the control group. If possible, recruitment will continue beyond 60 patients to provide more accurate and definitive trial results. The total number of patients recruited will depend on the pandemic and be guided by the data monitoring and ethics committee (DMEC).

Trial Status: REALIST Phase 1 completed in January 2020 prior to the COVID-19 pandemic. This was an open label dose escalation study of REALIST ORBCEL-C in patients with ARDS. The COVID-19 pandemic emerged as REALIST Phase 2 was planned to commence and the investigator team decided to repurpose the Phase 2 trial as a COVID-19 specific trial. This decision was discussed and approved by the Trial Steering Committee (TSC) and DMEC. Submissions were made to the Research Ethics Committee (REC) and MHRA to amend the protocol to a COVID-19 specific patient population and the protocol amendment was accepted by the REC on 27 March 2020 and MHRA on 30 March 2020 respectively. Other protocol changes in this amendment included an increase in the time of onset of ARDS from 48 to 72 hours, inclusion of clinical outcomes as secondary outcomes, the provision of an option for telephone consent, an indicative sample size and provision to continue recruitment beyond this indicative sample size. The current protocol in use is version 4.0 23.03.2020 (Additional file 1). Urgent Public Health status was awarded by the NIHR on 2 April 2020 and the trial opened to recruitment and recruited the first participant the same day. At the time of publication the trial was open to recruitment at 5 sites across the UK (Belfast Health and Social Care Trust, King's College London, Guys and St Thomas' Hospital London, Birmingham Heartlands Hospital and the Queen Elizabeth Hospital Birmingham) and 12 patients have been recruited across these sites. Additional sites are planned to open and appropriate approvals for these are being obtained. It is estimated recruitment will continue for 6 months.

Trial Registration: ClinicalTrials.gov NCT03042143 (Registered 3 Feb 2017). EudraCT 2017-000585-33 (Registered 28 Nov 2017).

Full Protocol: The full protocol (version 4.0 23.03.2020) is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7267756PMC
June 2020

Early switch from intravenous to oral antibiotic therapy in patients with cancer who have low-risk neutropenic sepsis (the EASI-SWITCH trial): study protocol for a randomised controlled trial.

Trials 2020 May 27;21(1):431. Epub 2020 May 27.

Centre for Cancer Research and Cell Biology, Queen's University Belfast, Lisburn Road, Belfast, BT9 7AE, UK.

Background: Neutropenic sepsis remains a common treatment complication for patients receiving systemic anti-cancer treatment. The UK National Institute for Health and Care Excellence have not recommended switching from empirical intravenous antibiotics to oral antibiotics within 48 h for patients assessed as low risk for septic complications because of uncertainty about whether this would achieve comparable outcomes to using intravenous antibiotics for longer. The UK National Institute for Health Research funded the EASI-SWITCH trial to tackle this uncertainty.

Methods: The trial is a pragmatic, randomised, non-inferiority trial that aims to establish the clinical and cost-effectiveness of early switching from intravenous to oral antibiotics in cancer patients with low-risk neutropenic sepsis. Patients ≥ 16 years, receiving systemic anti-cancer treatment (acute leukaemics/stem cell transplants excluded), with a temperature of > 38 °C, neutrophil count ≤ 1.0 × 10/L, MASCC (Multinational Association of Supportive Care in Cancer) score ≥ 21 and receiving IV piperacillin/tazobactam or meropenem for less than 24 h are eligible to participate. Patients are randomised 1:1 either (i) to switch to oral ciprofloxacin and co-amoxiclav within 12-24 h of commencing intravenous antibiotics, completing at least 5 days total antibiotics (intervention), or (ii) to continue intravenous antibiotics for at least 48 h, with ongoing antibiotics being continued at the physician's discretion (control). Patients are discharged home when their physician deems it appropriate. The primary outcome measure is a composite of treatment failures as assessed at day 14. The criteria for treatment failure include fever persistence or recurrence 72 h after starting intravenous antibiotics, escalation from protocolised antibiotics, hospital readmission related to infection/antibiotics, critical care support or death. Based on a 15% treatment failure rate in the control group and a 15% non-inferiority margin, the recruitment target is 230 patients.

Discussion: If the trial demonstrates non-inferiority of early switching to oral antibiotics, with potential benefits for patient quality of life and resource savings, this finding will have significant implications for the routine clinical management of those with low-risk neutropenic sepsis.

Trial Registration: ISRCTN: 84288963. Registered on the 1 July 2015. https://doi.org/10.1186/ISRCTN84288963. EudraCT: 2015-002830-35.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7251886PMC
May 2020

Controversy and Debate Series on Core Outcome Sets. Paper 4: Debate on Paper 1 from the perspective of COMET [Core Outcome Measures in Effectiveness Trials].

J Clin Epidemiol 2020 09 13;125:222-224. Epub 2020 May 13.

MRC-NIHR Trials Methodology Research Partnership, University of Liverpool, Liverpool L63 3GL, UK.

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September 2020

Obtaining and managing data sets for individual participant data meta-analysis: scoping review and practical guide.

BMC Med Res Methodol 2020 05 12;20(1):113. Epub 2020 May 12.

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.

Background: Shifts in data sharing policy have increased researchers' access to individual participant data (IPD) from clinical studies. Simultaneously the number of IPD meta-analyses (IPDMAs) is increasing. However, rates of data retrieval have not improved. Our goal was to describe the challenges of retrieving IPD for an IPDMA and provide practical guidance on obtaining and managing datasets based on a review of the literature and practical examples and observations.

Methods: We systematically searched MEDLINE, Embase, and the Cochrane Library, until January 2019, to identify publications focused on strategies to obtain IPD. In addition, we searched pharmaceutical websites and contacted industry organizations for supplemental information pertaining to recent advances in industry policy and practice. Finally, we documented setbacks and solutions encountered while completing a comprehensive IPDMA and drew on previous experiences related to seeking and using IPD.

Results: Our scoping review identified 16 articles directly relevant for the conduct of IPDMAs. We present short descriptions of these articles alongside overviews of IPD sharing policies and procedures of pharmaceutical companies which display certification of Principles for Responsible Clinical Trial Data Sharing via Pharmaceutical Research and Manufacturers of America or European Federation of Pharmaceutical Industries and Associations websites. Advances in data sharing policy and practice affected the way in which data is requested, obtained, stored and analyzed. For our IPDMA it took 6.5 years to collect and analyze relevant IPD and navigate additional administrative barriers. Delays in obtaining data were largely due to challenges in communication with study sponsors, frequent changes in data sharing policies of study sponsors, and the requirement for a diverse skillset related to research, administrative, statistical and legal issues.

Conclusions: Knowledge of current data sharing practices and platforms as well as anticipation of necessary tasks and potential obstacles may reduce time and resources required for obtaining and managing data for an IPDMA. Sufficient project funding and timeline flexibility are pre-requisites for successful collection and analysis of IPD. IPDMA researchers must acknowledge the additional and unexpected responsibility they are placing on corresponding study authors or data sharing administrators and should offer assistance in readying data for sharing.
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http://dx.doi.org/10.1186/s12874-020-00964-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7218569PMC
May 2020

Strengthening prehospital clinical practice guideline implementation in South Africa: a qualitative case study.

BMC Health Serv Res 2020 Apr 24;20(1):349. Epub 2020 Apr 24.

Centre for Evidence-based Health Care, Division of Epidemiology and Biostatistics, Department of Global Health, Stellenbosch University, Cape Town, South Africa.

Background: Methods on developing new (de novo) clinical practice guidelines (CPGs) have received substantial attention. However, research into alternative methods of CPG development using existing CPG documents (CPG adaptation) - a specific issue for guideline development groups in low- and middle-income countries - is sparse. There are only a few examples showcasing the pragmatic application of such alternative approaches in settings with time and budget constraints, especially in the prehospital setting. This paper aims to describe and strengthen the methods of developing prehospital CPGs using alternative guideline development methods through a case study design.

Methods: We qualitatively explored a CPG development project conducted in 2016 for prehospital providers in South Africa as a case study. Key stakeholders, involved in various processes of the guideline project, were purposefully sampled. Data were collected from one focus group and six in-depth interviews and analysed using thematic analysis. Overarching themes and sub-themes were inductively developed and categorised as challenges and recommendations and further transformed into action points.

Results: Key challenges revolved around guideline implementation as opposed to development. These included the unavoidable effect of interest and beliefs on implementing recommendations, the local evidence void, a shifting implementation context, and opposing end-user needs. Guideline development and implementation strengthening priority actions included: i) developing a national end-user document; ii) aligning recommendations with local practice; iii) communicating a clear and consistent message; iv) addressing controversial recommendations; v) managing the impact of interests, beliefs and intellectual conflicts; and vi) transparently reporting implementation decisions.

Conclusion: The cornerstone of a successful guideline development process is the translation and implementation of CPG recommendations into clinical practice. We highlight key priority actions for prehospital guideline development teams with limited resources to strengthen guideline development, dissemination, and implementation by drawing from lessons learnt from a prehospital guideline project conducted in South Africa.
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http://dx.doi.org/10.1186/s12913-020-05111-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7183123PMC
April 2020

Traditional Chinese herbal medicine for treating novel coronavirus (COVID-19) pneumonia: protocol for a systematic review and meta-analysis.

Syst Rev 2020 04 8;9(1):75. Epub 2020 Apr 8.

School of Health Preservation and Rehabilitation, Chengdu University of Traditional Chinese Medicine, Chengdu, China.

Background: A new type of coronavirus, novel coronavirus (COVID-19), is causing an increasing number of cases of pneumonia and was declared a Public Health Emergency of International Concern by the World Health Organization on 30 January 2020. The virus first appeared in Wuhan, China, in late December 2019, and traditional Chinese herbal medicine is being used for its treatment. This systematic review and meta-analysis will assess studies of the effects of traditional Chinese herbal medicine in COVID-19 pneumonia.

Methods: We will search electronic databases including PubMed, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), Chinese Science and Technology Periodical Database (VIP), and Wanfang database using keywords related to COVID-19 and traditional Chinese herbal medicine. Reference lists of relevant trials and reviews will be searched. We will manually search gray literature, such as conference proceedings and academic degree dissertations, and trial registries. Two independent reviewers will screen studies (XL and DZ), extract data (YL and LG), and evaluate risk of bias (YL and DZ). Data analysis will be conducted using the Review Manager software (version 5.3.5) and R software (version 3.6.1). Statistical heterogeneity will be assessed using a standard chi-square test with a significance level of P < 0.10. Biases associated with study size (e.g., publication bias) will be investigated using funnel plots, Egger's test and Begg's test, and Trim and Fill analysis.

Discussion: This study will provide a high-quality synthesis of the effects of traditional Chinese herbal medicine for COVID-19. The use of traditional Chinese herbal medicine for treatment or prevention of these novel viral infections affecting the pneumonia will be investigated.

Systematic Review Registration: PROSPERO registration number: CRD42020168004.
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http://dx.doi.org/10.1186/s13643-020-01343-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7138957PMC
April 2020

Reporting of Outcomes and Outcome Measures in Studies of Interventions to Prevent and/or Treat Delirium in the Critically Ill: A Systematic Review.

Crit Care Med 2020 04;48(4):e316-e324

Intensive Care Unit, Watford General Hospital, Watford, United Kingdom.

Objectives: To inform development of a core outcome set, we evaluated the scope and variability of outcomes, definitions, measures, and measurement time-points in published clinical trials of pharmacologic or nonpharmacologic interventions, including quality improvement projects, to prevent and/or treat delirium in the critically ill.

Data Sources: We searched electronic databases, systematic review repositories, and trial registries (1980 to March 2019).

Study Selection And Data Extraction: We included randomized, quasi-randomized, and nonrandomized intervention studies of pharmacologic and nonpharmacologic interventions. We extracted data on study characteristics, verbatim descriptions of study outcomes, and measurement characteristics. We assessed quality of outcome reporting using the Management of Otitis Media with Effusion in Children with Cleft Palate study scoring system; risk of bias and study quality using the Cochrane tool and Scottish Intercollegiate Guidelines Network checklists. We categorized reported outcomes using Core Outcome Measures in Effectiveness Trials taxonomy.

Data Synthesis: From 195 studies (1/195 pediatric) recruiting 74,632 participants and reporting a mean (SD) of 10 (6.2) outcome domains, we identified 12 delirium-specific outcome domains. Delirium incidence (147, 75% of studies), duration (67, 34%), and antipsychotic use (42, 22%) were most commonly reported. We identified a further 94 non-delirium-specific outcome domains within 19 Core Outcome Measures in Effectiveness Trials taxonomy categories. For both delirium-specific and nonspecific outcome domains, we found multiple outcomes in domains due to differing descriptions and time-points. The Confusion Assessment Method-ICU with Richmond Agitation-Sedation Scale to assess sedation was the most common measure used to ascertain delirium (51, 35%). Measurement generally began at randomization or ICU admission, and lasted from 1 to 30 days, ICU/hospital discharge. Frequency of measurement was highly variable with daily measurement and greater than daily measurement reported for 36% and 37% of studies, respectively.

Conclusions: We identified substantial heterogeneity and multiplicity of outcome selection and measurement in published studies. These data will inform the consensus building stage of a core outcome set to inform delirium research in the critically ill.
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April 2020

OptiBIRTH: a cluster randomised trial of a complex intervention to increase vaginal birth after caesarean section.

BMC Pregnancy Childbirth 2020 Mar 6;20(1):143. Epub 2020 Mar 6.

Trinity College Dublin, Dublin, Ireland.

Background: Despite evidence supporting the safety of vaginal birth after caesarean section (VBAC), rates are low in many countries.

Methods: OptiBIRTH investigated the effects of a woman-centred intervention designed to increase VBAC rates through an unblinded cluster randomised trial in 15 maternity units with VBAC rates < 35% in Germany, Ireland and Italy. Sites were matched in pairs or triplets based on annual birth numbers and VBAC rate, and randomised, 1:1 or 2:1, intervention versus control, following trial registration. The intervention involved evidence-based education of clinicians and women with one previous caesarean section (CS), appointment of opinion leaders, audit/peer review, and joint discussions by women and clinicians. Control sites provided usual care. Primary outcome was annual hospital-level VBAC rates before the trial (2012) versus final year of the trial (2016). Between April 2014 and October 2015, 2002 women were recruited (intervention 1195, control 807), with mode-of-birth data available for 1940 women.

Results: The OptiBIRTH intervention was feasible and safe across hospital settings in three countries. There was no statistically significant difference in the change in the proportion of women having a VBAC between intervention sites (25.6% in 2012 to 25.1% in 2016) and control sites (18.3 to 22.3%) (odds ratio adjusted for differences between intervention and control groups (2012) and for homogeneity in VBAC rates at sites in the countries: 0.87, 95% CI: 0.67, 1.14, p = 0.32 based on 5674 women (2012) and 5284 (2016) with outcome data. Among recruited women with birth data, 4/1147 perinatal deaths > 24 weeks gestation occurred in the intervention group (0.34%) and 4/782 in the control group (0.51%), and two uterine ruptures (one per group), a rate of 1:1000.

Conclusions: Changing clinical practice takes time. As elective repeat CS is the most common reason for CS in multiparous women, interventions that are feasible and safe and that have been shown to lead to decreasing repeat CS, should be promoted. Continued research to refine the best way of promoting VBAC is essential. This may best be done using an implementation science approach that can modify evidence-based interventions in response to changing clinical circumstances.

Trial Registration: The OptiBIRTH trial was registered on 3/4/2013. Trial registration number ISRCTN10612254.
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http://dx.doi.org/10.1186/s12884-020-2829-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7059398PMC
March 2020

Modifiable Lifestyle and Medical Risk Factors Associated With Myeloproliferative Neoplasms.

Hemasphere 2020 Feb 3;4(1):e327. Epub 2020 Jan 3.

Centre for Medical Education, Queen's University Belfast, Belfast, Northern Ireland and Belfast Health and Social Care Trust, Northern Ireland.

Despite the identification of acquired genetic mutations associated with Myeloproliferative Neoplasms (MPNs) there is a paucity of information relating to modifiable risk factors that may lead to these mutations. The MOSAICC Study was an exploratory case-control study of polycythemia vera (PV), essential thrombocythemia (ET), and Myelofibrosis (MF). MPN patients and population controls (identified by General Practitioners) and non-blood relative/friend controls were recruited from 2 large UK centers. Participants completed a telephone-based questionnaire analyzed by unconditional logistic regression analysis adjusting for potential confounders. Risk factors for MPNs identified included increasing childhood household density [odds ratio (OR) 2.55, 95% confidence interval (CI) 1.16-5.62], low childhood socioeconomic status (OR 2.30, 95%CI 1.02-5.18) and high pack years smoking (OR 2.19, 95%CI 1.03-4.66) and current smoking restricted to JAK2 positive PV cases (OR 3.73, 95%CI 1.06-13.15). Obesity was linked with ET (OR 2.59, 95%CI 1.02-6.58) confirming results in previous cohort studies. Receipt of multiple CT scans was associated with a strongly increased risk of MPN although with wide confidence intervals (OR 5.38, 95%CI 1.67-17.3). Alcohol intake was inversely associated with risk of PV (OR 0.41, 95%CI 0.19-0.92) and ET (OR 0.48, 95%CI 0.24-0.98). The associations with childhood household density, high pack years smoking and alcohol were also seen in multivariate analysis. This is the largest case control study in MPNs to date and confirms the previously reported associations with obesity and cigarette smoking from cohort studies in addition to novel associations. In particular, the role of smoking and JAK2 mutation cases merits further evaluation.
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http://dx.doi.org/10.1097/HS9.0000000000000327DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7000482PMC
February 2020

A qualitative study of the factors influencing recruitment to a pilot trial on the prevention of striae gravidarum.

BMC Pregnancy Childbirth 2020 Feb 12;20(1):103. Epub 2020 Feb 12.

School of Nursing and Midwifery, Aras Moyola, National University of Ireland Galway, Galway, H91 TK33, Ireland.

Background: Striae gravidarum are a common occurrence in pregnancy and many women use a topical product to prevent their development or lessen their appearance if they do develop. There is a lack of evidence on the effectiveness of many of the products used by women. This study arose from challenges in recruitment to a pilot randomised trial (ISRCTN trial registration number:76992326) designed to evaluate the feasibility of a definitive trial to compare a moisturising oil to no treatment in the prevention and reduction in severity of striae gravidarum. The study reported here explored the factors influencing recruitment to that pilot trial.

Methods: A qualitative descriptive study was undertaken involving primigravid women attending an Irish maternity hospital. Data were collected by semi-structured telephone interviews over a four-week period and analysed using the framework method of analysis. Fifteen interview transcripts were included in the analysis.

Results: Four main themes consisting of twelve categories were identified from the interview data. The themes focused on women's prevention of stretch marks and their choice of anti-stretch mark product, who and what influenced that choice and influences on trial participation. In relation to influences on trial participation, the possibility of being randomised to the non- intervention or control group was a deterrent for many women.

Conclusions: The prevention of stretch marks is important to pregnant women, as is their choice of product to prevent them. Offering women the opportunity to be part of a trial that would be of low burden and would test a well-known product may optimise recruitment. However, reluctance to be randomised because of the possibility of being allocated to the non-intervention control group suggests that further work is needed in this field on how best to communicate uncertainty to potential participants.
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http://dx.doi.org/10.1186/s12884-020-2781-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7017448PMC
February 2020

Anticipatory care planning intervention for older adults at risk of functional decline: study protocol for a primary care cluster feasibility randomised trial.

Trials 2020 Feb 11;21(1):168. Epub 2020 Feb 11.

Royal College of Surgeons in Ireland, 123 St Stephen's Green, Dublin, D02 YN77, Ireland.

Background: The treatment and management of long-term health conditions is the greatest challenge facing health systems around the world today. Innovative approaches to patient care in the community such as Anticipatory Care Planning (ACP), which seek to help with the provision of high-quality comprehensive care to older adults at risk of functional decline, require evaluation. This study will evaluate one approach that will include primary care as the setting for ACP.

Methods/design: This study will help to determine the feasibility for a definitive randomised trial to evaluate the implementation and outcomes of an ACP intervention. The intervention will be delivered by specially trained registered nurses in a primary care setting with older adults identified as at risk of functional decline. The intervention will comprise: (a) information collection via patient assessment; (b) facilitated informed dialogue between the patient, family carer, general practitioner and other healthcare practitioners; and, (c) documentation of the agreed support plan and follow-up review dates. Through a structured consultation with patients and their family carers, the nurses will complete a mutually agreed personalised support plan.

Discussion: This study will determine the feasibility for a full trial protocol to evaluate the implementation and outcomes of an (ACP) intervention in primary care to assist older adults aged 70 years of age or older and assessed as being at risk of functional decline. The study will be implemented in two jurisdictions on the island of Ireland which employ different health systems but which face similar health challenges. This study will allow us to examine important issues, such as the impact of two different healthcare systems on the health of older people and the influence of different legislative interpretations on undertaking cross jurisdictional research in Ireland.

Protocol Version: Version 1, 17 September 2019.

Trial Registration: Clinicaltrials.gov, ID: NCT03902743. Registered on 4 April 2019.
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http://dx.doi.org/10.1186/s13063-020-4100-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7014651PMC
February 2020

Resilience, burnout and coping mechanisms in UK doctors: a cross-sectional study.

BMJ Open 2020 01 27;10(1):e031765. Epub 2020 Jan 27.

General Surgery, Ulster Hospital, Dundonald, UK.

Aims: This cross-sectional study aimed to assess resilience, professional quality of life and coping mechanisms in UK doctors. It also aimed to assess the impact of demographic variables, such as sex, grade and specialty on these factors.

Methods: During October and November 2018, medical doctors in the UK were eligible to complete an online survey made up of validated psychological instruments. Royal Colleges and other medical organisations invited their membership to participate via newsletters, email invitations, websites and social media.

Results: 1651 doctors participated from a wide range of specialties and grades across the UK. The mean resilience score was 65.01 (SD 12.3), lower than population norms. Of those who responded, 31.5% had high burnout (BO), 26.2% had high secondary traumatic stress and 30.7% had low compassion satisfaction (CS). Doctors who responded from emergency medicine were more burned out than any other specialty group (F=2.62, p=0.001, df 14). Those who responded from general practice scored lowest for CS (F=6.43, p<0.001, df 14). 120 (8%) doctors met the criteria for all three of high BO, high STS and low CS. The most frequently reported coping mechanism was the maladaptive strategy of self-distraction.

Conclusions: One-third of UK doctors who responded are burned out and suffering from STS. Those who responded from emergency medicine and general practice appear to be suffering the most. Over 100 doctors fell into the at-risk category of high BO, high STS and low CS. Future analysis of the free text responses from doctors may help to identify factors that are playing a role in the high levels of BO and STS being reported by medical staff.
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http://dx.doi.org/10.1136/bmjopen-2019-031765DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7045750PMC
January 2020

Fool's gold? Why blinded trials are not always best.

BMJ 2020 01 21;368:l6228. Epub 2020 Jan 21.

Northern Ireland Clinical Trials Unit and Methodology Hub, Centre for Public Health, Queen's University Belfast, Belfast, UK.

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January 2020

The research burden of randomized controlled trial participation: a systematic thematic synthesis of qualitative evidence.

BMC Med 2020 01 20;18(1). Epub 2020 Jan 20.

Université de Paris, CRESS, INSERM, INRA, F-75004, Paris, France.

Background: Participation in randomized controlled trials (RCTs) may be quite demanding and could represent an important burden for patients. We aimed to explore this research burden (i.e., the psychological, physical, and financial burdens) experienced by patients through their participation in a RCT.

Methods: We conducted a systematic review of qualitative studies exploring adult patients' experiences with RCT participation. We searched MEDLINE (PubMed), CINAHL, PSYCHINFO, and Embase (search date March 2018) for eligible reports. Qualitative data coding and indexing were assisted by NVivo. The quality of reports was assessed by using the Critical Appraisal Skills Program (CASP) tool.

Results: We included 45 qualitative studies that involved 1732 RCT participants. Important psychological burdens were identified at every stage of the trial process. Participants reported feeling anxiety and being afraid of "being a 'guinea pig'" and described undergoing randomization and allocation to a placebo as particularly difficult resulting in disappointment, anger, and depression. Patients' follow-up and trial closure were also responsible for a wide range of psychological, physical, and financial burdens. Furthermore, factors related to burdensome impacts and consequences were discerned. These factors involved trial information, poorly organized and too-demanding follow-up, and lack of appropriate management when the patient's participation ended. Trial participation was also associated with beneficial effects such as the satisfaction of feeling "useful," gaining "a sense of control," and receiving special attention.

Conclusions: Our finding provides a detailed description of research burden across the whole RCT process. Many of the burdens described could be anticipated, and some avoided in a movement toward minimally disruptive clinical research. Such an approach could improve trial recruitment and retention.

Review Registration: PROSPERO CRD42018098994.
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http://dx.doi.org/10.1186/s12916-019-1476-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6970283PMC
January 2020