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  1. Article ; Online: Reducing Self-harm in Adolescents. An individual participant data meta-analysis (RISA-IPD)

    David Cottrell / Peter Fonagy / Amanda Farrin / Alexandra Wright-Hughes / Daniel Stahl / Dennis Ougrin / Rebecca Walwyn

    BMJ Open, Vol 11, Iss

    systematic review protocol

    2021  Volume 5

    Abstract: Introduction Up to 10% of adolescents report self-harm in the previous year. Non-fatal repetition is common (18% in 1 year), death from any cause shows a fourfold and suicide a 10-fold excess. Despite the scale of the problem, there is insufficient ... ...

    Abstract Introduction Up to 10% of adolescents report self-harm in the previous year. Non-fatal repetition is common (18% in 1 year), death from any cause shows a fourfold and suicide a 10-fold excess. Despite the scale of the problem, there is insufficient evidence for effective interventions for self-harm. Those who self-harm do so for a variety of different reasons. Different treatments may be more effective for subgroups of adolescents; however, little is known about which subgroups are appropriate for further study. This protocol outlines a systematic review and individual participant data meta-analysis (IPD-MA) to identify subgroups of adolescents for which therapeutic interventions for self-harm show some evidence of benefit.Methods and analysis A systematic literature search was conducted in August 2019 (including Cochrane Library, Embase, trial registers and other databases). An update search is planned. Study selection will identify randomised controlled trials examining interventions to reduce self-harm in adolescents who have self-harmed and presented to services. Identified research teams will be invited to contribute data and form a collaborative group. Two-stage IPD-MA will be used to evaluate effectiveness of different therapeutic interventions compared with any active or non-active control on repetition of self-harm, general psychopathology, depression, suicidal ideation, quality of life and death. Subgroup analyses will identify adolescent subgroups in whom different therapeutic interventions may be more effective. Meta-regression will explore moderating study and intervention effects. Sensitivity analyses will incorporate aggregate data from studies lacking IPD and test the robustness of results to methods for handling missing data, within-study clustering, non-adherence and study quality.Ethics and dissemination Ethical approval is provided by the University of Leeds, Faculty of Medicine and Health Ethics Committee (18-098). Outcomes will inform research recommendations and will be disseminated ...
    Keywords Medicine ; R
    Subject code 170
    Language English
    Publishing date 2021-06-01T00:00:00Z
    Publisher BMJ Publishing Group
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: Cancer patients’ needs assessment in primary care

    Scott Wilkes / Joseph Clark / Miriam Johnson / Amanda Farrin / Robbie Foy / David Meads / Alexandra Wright-Hughes / Petra Bijsterveld / Bethan Copsey / Jon Mark Dickson / Terry McCormack / Emma McNaught

    BMJ Open, Vol 12, Iss

    study protocol for a cluster randomised controlled trial (cRCT), economic evaluation and normalisation process theory evaluation of the needs assessment tool cancer (CANAssess)

    2022  Volume 5

    Keywords Medicine ; R
    Language English
    Publishing date 2022-05-01T00:00:00Z
    Publisher BMJ Publishing Group
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: A cluster randomised trial of a Needs Assessment Tool for adult Cancer patients and their carers (NAT-C) in primary care

    Joseph Clark / Elvis Amoakwa / Alexandra Wright-Hughes / John Blenkinsopp / David C Currow / David Meads / Amanda Farrin / Victoria Allgar / Una Macleod / Miriam Johnson

    PLoS ONE, Vol 16, Iss 1, p e

    A feasibility study.

    2021  Volume 0245647

    Abstract: Background People with cancer often have unidentified symptoms and social care needs. The Needs Assessment Tool-Cancer (NAT-C) is a validated, structured method of assessing patient/carer concerns and prompting action, to address unmet need. Aims Assess ... ...

    Abstract Background People with cancer often have unidentified symptoms and social care needs. The Needs Assessment Tool-Cancer (NAT-C) is a validated, structured method of assessing patient/carer concerns and prompting action, to address unmet need. Aims Assess feasibility and acceptability of a definitive two-armed cluster randomised trial of NAT-C in primary care by evaluating: recruitment of GP practices, patients and carers; most effective approach of ensuring NAT-C appointments, acceptability of study measures and follow-up. Methods Non-blinded, feasibility study in four General Practices, with cluster randomisation to method of NAT-C appointment delivery, and process evaluation. Adults with active cancer were invited to participate with or without carer. Practices cluster randomised (1:1) to Arm I: promotion and use of NAT-C with a NAT-C trained clinician or Arm II: clinician of choice irrespective of training status. Participants completed study questionnaires at: baseline, 1, 3 and 6 months. Patients booked a 20 minute needs-assessment appointment post-baseline. Patients, carers and GP practice staff views regarding the study sought through interviews/focus groups. Quantitative data were analysed descriptively. Qualitative data were analysed thematically, informed by Normalisation Process Theory. Progression to a definitive trial was assessed against feasibility outcomes, relating to: recruitment rate, uptake and delivery of the NAT-C, data collection and quality. Results Five GP practices approached, four recruited and trained to use the NAT-C. Forty-seven participants and 17 carers recruited. At baseline, 34/47 (72%) participants reported at least one moderate-severe unmet need, confirming study rationale. 32/47 (68%) participants received a NAT-C-guided consultation, 19 of which on Arm I. Study attrition at one month (n = 44 (94%), n = 16 (94%)), three months (n = 38 (81%), n = 14 (82%)) and six months (n = 32 (68%), n = 10 (59%)). Fifteen patient interviews conducted across the whole study and one focus ...
    Keywords Medicine ; R ; Science ; Q
    Subject code 420
    Language English
    Publishing date 2021-01-01T00:00:00Z
    Publisher Public Library of Science (PLoS)
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Problem-solving therapy rather than treatment as usual for adults after self-harm

    David Owens / Alexandra Wright-Hughes / Liz Graham / Paul Blenkiron / Kayleigh Burton / Michelle Collinson / Amanda Farrin / Simon Hatcher / Katie Martin / John O’Dwyer / Louise Pembroke / David Protheroe / Sandy Tubeuf / Allan House

    Pilot and Feasibility Studies, Vol 6, Iss 1, Pp 1-

    a pragmatic, feasibility, randomised controlled trial (the MIDSHIPS trial)

    2020  Volume 14

    Abstract: Abstract Background Non-fatal self-harm is one of the commonest reasons for adults’ emergency hospital attendance. Although strongly associated with fatal and non-fatal repetition, there is weak evidence about effective interventions—and no clear NICE ... ...

    Abstract Abstract Background Non-fatal self-harm is one of the commonest reasons for adults’ emergency hospital attendance. Although strongly associated with fatal and non-fatal repetition, there is weak evidence about effective interventions—and no clear NICE guidance or clinical consensus concerning aftercare. We examined the practicability of a definitive trial to evaluate problem-solving therapy (PST) to reduce repetition of self-harm; MIDSHIPS is a single-centre, parallel-group, individually randomised controlled feasibility trial comparing treatment-as-usual (TAU) alone to TAU plus up to six sessions of brief problem-solving therapy (PST) with adults who had recently attended hospital because of self-harm. Objectives were to adapt the intervention for a UK setting, train therapists, recruit and randomise patients, deliver PST under supervision, and establish comparative outcomes, assessed blindly. Methods We adapted the problem-solving intervention from an earlier trial and trained a mental-health nurse to deliver it. Adult patients attending the general hospital for self-harm were recruited while undergoing psychosocial assessment by the mental health team, and 62 were randomly allocated (32 TAU, 30 PST). The primary outcome assessed repeat hospital attendance due to further self-harm 6 months post-randomisation. Secondary outcomes included participant-reported outcomes and service use at 3 and 6 months post-randomisation. Results The recruitment period had to be extended and 710 patients screened in order to establish a trial sample of the planned size (N = 62). A quarter of participants allocated to PST did not undertake the therapy offered; those who received PST attended a median of three sessions. Secondary outcomes were established for 49 (79%) participants at 6 months; all participants’ hospital records were retrieved. Repetition of self-harm leading to hospital presentation occurred in 19 of the 62 participants (30.6%, 95% CI 19.2%, 42.1%) within 6 months of randomisation. Promising differential rates of self-harm were observed with an event rate of 23.3% (95% CI 8.2%, 38.5%) in the PST arm; and 37.5% (95% CI 20.7%, 54.3%) in TAU. Economic findings were also encouraging, with a small QALY gain (0.0203) in the PST arm together with less reported use of the NHS in the PST arm (average £2120) than with TAU-only (£2878). Conclusions The feasibility trial achieved its objectives despite considerable difficulties with recruitment—adapting the PST, training a therapist, recruiting patients who had recently self-harmed, delivering the therapy, and establishing primary and secondary outcomes. These data provide a robust platform for a definitive multicentre randomised controlled trial of brief problem-solving therapy after hospital attendance due to self-harm. Trial registration Identification number and URL: ISRCTN54036115 http://www.isrctn.com/search?q=midships . Registered: 13 January 2012
    Keywords Self-harm ; Problem-solving therapy ; Self-poisoning ; Self-injury ; Adults ; Feasibility RCT ; Medicine (General) ; R5-920
    Subject code 150
    Language English
    Publishing date 2020-08-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article ; Online: A randomised fractional factorial screening experiment to predict effective features of audit and feedback

    Alexandra Wright-Hughes / Thomas A. Willis / Stephanie Wilson / Ana Weller / Fabiana Lorencatto / Mohamed Althaf / Valentine Seymour / Amanda J. Farrin / Jillian Francis / Jamie Brehaut / Noah Ivers / Sarah L. Alderson / Benjamin C. Brown / Richard G. Feltbower / Chris P. Gale / Simon J. Stanworth / Suzanne Hartley / Heather Colquhoun / Justin Presseau /
    Rebecca Walwyn / Robbie Foy

    Implementation Science, Vol 17, Iss 1, Pp 1-

    2022  Volume 18

    Abstract: Abstract Background Audit and feedback aims to improve patient care by comparing healthcare performance against explicit standards. It is used to monitor and improve patient care, including through National Clinical Audit (NCA) programmes in the UK. ... ...

    Abstract Abstract Background Audit and feedback aims to improve patient care by comparing healthcare performance against explicit standards. It is used to monitor and improve patient care, including through National Clinical Audit (NCA) programmes in the UK. Variability in effectiveness of audit and feedback is attributed to intervention design; separate randomised trials to address multiple questions about how to optimise effectiveness would be inefficient. We evaluated different feedback modifications to identify leading candidates for further “real-world” evaluation. Methods Using an online fractional factorial screening experiment, we randomised recipients of feedback from five UK NCAs to different combinations of six feedback modifications applied within an audit report excerpt: use effective comparators, provide multimodal feedback, recommend specific actions, provide optional detail, incorporate the patient voice, and minimise cognitive load. Outcomes, assessed immediately after exposure to the online modifications, included intention to enact audit standards (primary outcome, ranked on a scale of −3 to +3, tailored to the NCA), comprehension, user experience, and engagement. Results We randomised 1241 participants (clinicians, managers, and audit staff) between April and October 2019. Inappropriate repeated participant completion occurred; we conservatively excluded participant entries during the relevant period, leaving a primary analysis population of 638 (51.4%) participants. None of the six feedback modifications had an independent effect on intention across the five NCAs. We observed both synergistic and antagonistic effects across outcomes when modifications were combined; the specific NCA and whether recipients had a clinical role had dominant influences on outcome, and there was an antagonistic interaction between multimodal feedback and optional detail. Among clinical participants, predicted intention ranged from 1.22 (95% confidence interval 0.72, 1.72) for the least effective combination in which ...
    Keywords Audit and feedback ; Randomised fractional factorial experiment ; MOST ; Behaviour change ; Medicine (General) ; R5-920
    Subject code 150
    Language English
    Publishing date 2022-05-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  6. Article ; Online: Interventions to optimise the outputs of national clinical audits to improve the quality of health care

    Thomas A Willis / Alexandra Wright-Hughes / Ana Weller / Sarah L Alderson / Stephanie Wilson / Rebecca Walwyn / Su Wood / Fabiana Lorencatto / Amanda Farrin / Suzanne Hartley / Jillian Francis / Valentine Seymour / Jamie Brehaut / Heather Colquhoun / Jeremy Grimshaw / Noah Ivers / Richard Feltbower / Justin Keen / Benjamin C Brown /
    Justin Presseau / Chris P Gale / Simon J Stanworth / Robbie Foy

    Health and Social Care Delivery Research, Vol 10, Iss

    a multi-method study including RCT

    2022  Volume 15

    Abstract: Background: National clinical audit programmes aim to improve patient care by reviewing performance against explicit standards and directing action towards areas not meeting those standards. Their impact can be improved by (1) optimising feedback content ...

    Abstract Background: National clinical audit programmes aim to improve patient care by reviewing performance against explicit standards and directing action towards areas not meeting those standards. Their impact can be improved by (1) optimising feedback content and format, (2) strengthening audit cycles and (3) embedding randomised trials evaluating different ways of delivering feedback. Objectives: The objectives were to (1) develop and evaluate the effects of modifications to feedback on recipient responses, (2) identify ways of strengthening feedback cycles for two national audits and (3) explore opportunities, costs and benefits of national audit participation in a programme of trials. Design: An online fractional factorial screening experiment (objective 1) and qualitative interviews (objectives 2 and 3). Setting and participants: Participants were clinicians and managers involved in five national clinical audits – the National Comparative Audit of Blood Transfusions, the Paediatric Intensive Care Audit Network, the Myocardial Ischaemia National Audit Project, the Trauma Audit & Research Network and the National Diabetes Audit – (objective 1); and clinicians, members of the public and researchers (objectives 2 and 3). Interventions: We selected and developed six online feedback modifications through three rounds of user testing. We randomised participants to one of 32 combinations of the following recommended specific actions: comparators reinforcing desired behaviour change; multimodal feedback; minimised extraneous cognitive load for feedback recipients; short, actionable messages followed by optional detail; and incorporating ‘the patient voice’ (objective 1). Main outcome measures: The outcomes were intended actions, including enactment of audit standards (primary outcome), comprehension, user experience and engagement (objective 1). Results: For objective 1, the primary analysis included 638 randomised participants, of whom 566 completed the outcome questionnaire. No modification independently increased ...
    Keywords clinical audit ; implementation ; quality improvement ; randomised controlled trial ; factorial ; user-computer interface ; behavioural sciences ; Medicine (General) ; R5-920 ; Public aspects of medicine ; RA1-1270
    Subject code 360 ; 300
    Language English
    Publishing date 2022-06-01T00:00:00Z
    Publisher NIHR Journals Library
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  7. Article ; Online: Pain self-management interventions for community-based patients with advanced cancer

    Michael I Bennett / Matthew J Allsop / Peter Allen / Christine Allmark / Bridgette M Bewick / Kath Black / Alison Blenkinsopp / Julia Brown / S José Closs / Zoe Edwards / Kate Flemming / Marie Fletcher / Robbie Foy / Mary Godfrey / Julia Hackett / Geoff Hall / Suzanne Hartley / Daniel Howdon / Nicholas Hughes /
    Claire Hulme / Richard Jones / David Meads / Matthew R Mulvey / John O’Dwyer / Sue H Pavitt / Peter Rainey / Diana Robinson / Sally Taylor / Angela Wray / Alexandra Wright-Hughes / Lucy Ziegler

    Programme Grants for Applied Research, Vol 9, Iss

    a research programme including the IMPACCT RCT

    2021  Volume 15

    Abstract: Background: Each year in England and Wales, 150,000 people die from cancer, of whom 110,000 will suffer from cancer pain. Research highlights that cancer pain remains common, severe and undertreated, and may lead to hospital admissions. Objective: To ... ...

    Abstract Background: Each year in England and Wales, 150,000 people die from cancer, of whom 110,000 will suffer from cancer pain. Research highlights that cancer pain remains common, severe and undertreated, and may lead to hospital admissions. Objective: To develop and evaluate pain self-management interventions for community-based patients with advanced cancer. Design: A programme of mixed-methods intervention development work leading to a pragmatic multicentre randomised controlled trial of a multicomponent intervention for pain management compared with usual care, including an assessment of cost-effectiveness. Participants: Patients, including those with metastatic solid cancer (histological, cytological or radiological evidence) and/or those receiving anti-cancer therapy with palliative intent, and health professionals involved in the delivery of community-based palliative care. Setting: For the randomised controlled trial, patients were recruited from oncology outpatient clinics and were randomly allocated to intervention or control and followed up at home. Interventions: The Supported Self-Management intervention comprised an educational component called Tackling Cancer Pain, and an eHealth component for routine pain assessment and monitoring called PainCheck. Main outcome measures: The primary outcome was pain severity (measured using the Brief Pain Inventory). The secondary outcomes included pain interference (measured using the Brief Pain Inventory), participants’ pain knowledge and experience, and cost-effectiveness. We estimated costs and health-related quality-of-life outcomes using decision modelling and a separate within-trial economic analysis. We calculated incremental cost-effectiveness ratios per quality-adjusted life-year for the trial period. Results: Work package 1 – We found barriers to and variation in the co-ordination of advanced cancer care by oncology and primary care professionals. We identified that the median time between referral to palliative care services and death for 42,758 patients ...
    Keywords palliative care ; cancer pain ; self-management ; education ; clinical trial ; Public aspects of medicine ; RA1-1270
    Subject code 360
    Language English
    Publishing date 2021-12-01T00:00:00Z
    Publisher NIHR Journals Library
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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