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  1. Article ; Online: Contamination within trials of community-based public health interventions

    Elizabeth Stamp / Holly Schofield / Victoria Laurina Roberts / Wendy Burton / Michelle Collinson / June Stevens / Amanda Farrin / Harry Rutter / Maria Bryant

    Pilot and Feasibility Studies, Vol 7, Iss 1, Pp 1-

    lessons from the HENRY feasibility study

    2021  Volume 10

    Abstract: Abstract Introduction Contamination occurs when participants allocated to trial control arms receive elements of the active intervention. Randomisation at cluster level, rather than individual level, may reduce or eliminate contamination, avoiding the ... ...

    Abstract Abstract Introduction Contamination occurs when participants allocated to trial control arms receive elements of the active intervention. Randomisation at cluster level, rather than individual level, may reduce or eliminate contamination, avoiding the dilution of intervention effectiveness that it may cause. However, cluster randomisation can result in selection bias and may not be feasible to deliver. We explored the extent of contamination in a qualitative study nested within a feasibility study of HENRY (Health, Exercise and Nutrition for the Really Young); a UK community-based child obesity prevention programme. We aimed to determine the nature and impact of contamination to inform a larger planned trial and other trials in community based public health settings. Method We invited participants to take part in the nested qualitative study who were already involved in the HENRY feasibility study. Semi-structured interviews/focus groups were conducted with children’s centre managers (n=7), children’s centre staff (n=15), and parents (n=29). Data were transcribed and analysed using an integrative approach. First, deductively organised using a framework guided by the topic guide and then organised using inductive thematic analysis. Results Potential for contamination between treatment arms was recognised by all stakeholder groups. Staff within the intervention centres presented the greatest risk of contamination, predominantly because they were often asked to work in other children centre’s (including control group centres). ‘Sharing of best practice’ by staff was reported to be a common and desirable phenomenon within community based settings. Parental sharing of HENRY messages was reported inconsistently; though some parents indicated a high degree of knowledge transfer within their immediate circles. Conclusions The extent of contamination identified has influenced the design of a future effectiveness trial of HENRY which will be clustered at the centre level (with geographically distinct clusters). The common ...
    Keywords Contamination ; Public health ; Childhood ; Community ; Obesity ; Randomised control trial ; Medicine (General) ; R5-920
    Subject code 360
    Language English
    Publishing date 2021-03-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  2. Article ; Online: Cluster randomised controlled feasibility study of HENRY

    Maria Bryant / Michelle Collinson / Wendy Burton / Elizabeth Stamp / Holly Schofield / Bethan Copsey / Suzanne Hartley / Edward Webb / Amanda J. Farrin

    Pilot and Feasibility Studies, Vol 7, Iss 1, Pp 1-

    a community-based intervention aimed at reducing obesity rates in preschool children

    2021  Volume 17

    Abstract: Abstract Background Community-based obesity prevention interventions are often commissioned despite the limited evidence base. HENRY (Health, Exercise, Nutrition for the Really Young) is a programme delivered to parents of preschool children across the ... ...

    Abstract Abstract Background Community-based obesity prevention interventions are often commissioned despite the limited evidence base. HENRY (Health, Exercise, Nutrition for the Really Young) is a programme delivered to parents of preschool children across the UK. Early evidence suggests that it may be effective, but a robust evaluation has not been conducted. We initiated a systematic evaluation of HENRY by studying the feasibility of conducting a multi-centre definitive trial to evaluate its effectiveness and cost-effectiveness to prevent obesity. Objectives were to assess the feasibility of recruiting local authorities, centres and parents; test processes and time required to train and certify intervention staff; explore HENRY commissioning processes; identify potential sources (and associated impact) of contamination; and consider the feasibility of trial procedures. Methods We conducted a multi-centre, open labelled, two group, prospective, cluster randomised, controlled, feasibility study, with embedded process evaluation and pre-defined criteria for progression to definitive trial. We sought to recruit 120 parents from 12 children’s centres, across two UK local authority (government) areas. Within each local authority, we planned to randomise three centres to HENRY and three to ‘standard care’ control. Our plan was to collect data in family homes at baseline and 12 months, including parent and child height and weight, and parent-reported questionnaires on self-efficacy, feeding, eating habits, quality of life and resource use. Contamination, implementation and study acceptability were explored using parent interviews. Results We recruited two local authorities and 12 children’s centres within eight months. One hundred and seventeen parents were recruited (average 3.9 parents per programme) and follow-up data were collected from 85% of participants. Process data from 20 parents and 24 members of staff indicate that both would benefit from more detail about their involvement as participants, but that methods were ...
    Keywords Childhood obesity ; Community ; Prevention ; Parent programme ; Public health ; Medicine (General) ; R5-920
    Subject code 360
    Language English
    Publishing date 2021-02-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  3. Article ; Online: Characteristics and general practice resource use of people with comorbid cancer and dementia in England

    Michelle Collinson / Ellen Mason / Rachael Kelley / Alys Griffiths / Laura Ashley / Ann Henry / Hayley Inman / Fiona Cowdell / June Hennell / Liz Jones / Maria Walsh / Margaret Ogden / Amanda Farrin / Claire Surr

    BMC Primary Care, Vol 23, Iss 1, Pp 1-

    a retrospective cross-sectional study

    2022  Volume 13

    Abstract: Abstract Background Cancer and dementia are common in older people and management of the conditions as comorbidities can be challenging, yet little is known about the size or characteristics of this group. We aimed to estimate the prevalence, ... ...

    Abstract Abstract Background Cancer and dementia are common in older people and management of the conditions as comorbidities can be challenging, yet little is known about the size or characteristics of this group. We aimed to estimate the prevalence, characteristics and general practice resource usage of people living with both conditions in England. Methods Anonymised electronic healthcare records from 391 National Health Service general practices across England using the TPP SystmOne general practice system were obtained from ResearchOne. Data included demographic and clinical characteristics, and general practice healthcare useage (appointments, prescriptions, referrals and secondary care contacts) for people aged 50 and over with a cancer and/or dementia diagnosis consistent with the Quality and Outcomes Framework between 2005 and 2016. Multi-level negative binomial regression was used to analyse the association between having cancer and/or dementia and the number of general practice appointments. Results Data from 162,371 people with cancer and/or dementia were analysed; 3616 (2.2%) people were identified as having comorbid cancer and dementia. Of people with cancer, 3.1% also had dementia, rising to 7.5% (1 in 13 people) in those aged 75 and over. Fewer people with both conditions were female (50.7%) compared to those with dementia alone (65.6%) and those with comorbid cancer and dementia were older than those with cancer alone [mean ages 83 (sd = 7), 69 (sd = 12) respectively]. Those with both conditions were less likely to have lung cancer than those with cancer alone (7.5% vs. 10.3%) but more likely to have prostate cancer (20.9% vs. 15.8%). Additional comorbidities were more prevalent for those with both conditions than those with cancer or dementia alone (68.4% vs. 50.2% vs. 54.0%). In the year following the first record of either condition, people with cancer and dementia had 9% more general practice appointments (IRR:1.09, 95% CI:1.01–1.17) than those with cancer alone and 37% more appointments than those ...
    Keywords Cancer ; Dementia ; Older adults ; Primary health care ; Administrative data ; Electronic health records ; Medicine (General) ; R5-920
    Subject code 360
    Language English
    Publishing date 2022-11-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: A cluster RCT and process evaluation of an implementation optimisation intervention to promote parental engagement enrolment and attendance in a childhood obesity prevention programme

    Maria Bryant / Wendy Burton / Michelle Collinson / Amanda Farrin / Jane Nixon / June Stevens / Kim Roberts / Robbie Foy / Harry Rutter / Bethan Copsey / Suzanne Hartley / Sandy Tubeuf / Julia Brown

    Trials, Vol 22, Iss 1, Pp 1-

    results of the Optimising Family Engagement in HENRY (OFTEN) trial

    2021  Volume 21

    Abstract: Abstract Background Poor and variable implementation of childhood obesity prevention programmes reduces their population impact and sustainability. We drew upon ethnographic work to develop a multi-level, theory-based implementation optimisation ... ...

    Abstract Abstract Background Poor and variable implementation of childhood obesity prevention programmes reduces their population impact and sustainability. We drew upon ethnographic work to develop a multi-level, theory-based implementation optimisation intervention. This intervention aimed to promote parental enrolment and attendance at HENRY (Health Exercise Nutrition for the Really Young), a UK community obesity prevention programme, by changing behaviours of children’s centre and local authority stakeholders. Methods We evaluated the effectiveness of the implementation optimisation intervention on HENRY programme enrolment and attendance over a 12-month implementation period in a cluster randomised controlled trial. We randomised 20 local government authorities (with 126 children’s centres) to HENRY plus the implementation optimisation intervention or to HENRY alone. Primary outcomes were (1) the proportion of centres enrolling at least eight parents per programme and (2) the proportion of centres with a minimum of 75% of parents attending at least five of eight sessions per programme. Trial analyses adjusted for stratification factors (pre-randomisation implementation of HENRY, local authority size, deprivation) and allowed for cluster design. A parallel mixed-methods process evaluation used qualitative interviews and routine monitoring to explain trial results. Results Neither primary outcome differed significantly between groups; 17.8% of intervention centres and 18.0% of control centres achieved the parent enrolment target (adjusted difference − 1.2%; 95% CI − 19.5%, 17.1%); 17.1% of intervention centres and 13.9% of control centres achieved the attendance target (adjusted difference 1.2%; 95% CI − 15.7%, 18.1%). Unexpectedly, the trial coincided with substantial national service restructuring, including centre closures and reduced funds. Some commissioning and management teams stopped or reduced delivery of both HENRY and the implementation optimisation intervention due to competing demands. Thus, at follow-up, ...
    Keywords Community ; Parent ; Engagement ; Enrolment ; Attendance ; Obesity ; Medicine (General) ; R5-920
    Subject code 360
    Language English
    Publishing date 2021-11-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  5. Article ; Online: Acceptance and Commitment Therapy to support medication decision-making and quality of life in women with breast cancer

    Samuel G. Smith / Rachel Ellison / Louise Hall / Jane Clark / Suzanne Hartley / Ellen Mason / Jamie Metherell / Catherine Olivier / Vicky Napp / Jay Naik / Sarah Buckley / Charlotte Hirst / Sue Hartup / Richard D. Neal / Galina Velikova / Amanda Farrin / Michelle Collinson / Christopher D. Graham

    Pilot and Feasibility Studies, Vol 8, Iss 1, Pp 1-

    protocol for a pilot randomised controlled trial

    2022  Volume 17

    Abstract: Abstract Background Adherence to adjuvant endocrine therapy is affected by medication side-effects and associated distress. Previous interventions focused on educating women to enhance adherence have proved minimally effective. We co-designed an ... ...

    Abstract Abstract Background Adherence to adjuvant endocrine therapy is affected by medication side-effects and associated distress. Previous interventions focused on educating women to enhance adherence have proved minimally effective. We co-designed an Acceptance and Commitment Therapy (ACT) intervention to enhance medication decision-making and quality of life by targeting a broader range of factors, including side-effect management and psychological flexibility. This study aims to establish key trial parameters, assess the acceptability of the intervention and the extent to which it can be delivered with fidelity, and to demonstrate “proof of principle” regarding its efficacy on primary and process outcomes. Methods The ACTION intervention includes an individual 1:1 ACT session followed by three group sessions involving 8–10 women and two practitioner psychologists. Participants are also provided with access to a website containing evidence-based methods for self-managing side-effects. The ACT sessions were adapted during the COVID-19 pandemic to be remotely delivered via video conferencing software. To evaluate the feasibility and acceptability of this intervention, a multi-site, exploratory, two-arm, individually randomised external pilot trial with a nested qualitative study will be undertaken. Eighty women with early stage breast cancer prescribed adjuvant endocrine therapy will be randomised (1:1) to receive treatment as usual or treatment as usual plus the ACTION intervention. The planned future primary outcome is medication adherence assessed by the ASK-12 measure. Progression to a phase III RCT will be based on criteria related to recruitment and follow-up rates, acceptability to patients, competency and fidelity of delivery, and proof of principle for change in medication adherence. Discussion This external pilot trial will be used to ascertain the feasibility of undertaking a future phase III RCT to definitively evaluate an ACT-based intervention to support medication taking behaviour and quality of life in ...
    Keywords Medication adherence ; Breast cancer ; Acceptance and Commitment Therapy ; Pilot ; Quality of life ; Remote delivery ; Medicine (General) ; R5-920
    Subject code 610
    Language English
    Publishing date 2022-02-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  6. Article ; Online: Explaining variable effects of an adaptable implementation package to promote evidence-based practice in primary care

    Liz Glidewell / Cheryl Hunter / Vicky Ward / Rosemary R. C. McEachan / Rebecca Lawton / Thomas A. Willis / Suzanne Hartley / Michelle Collinson / Michael Holland / Amanda J. Farrin / Robbie Foy / on behalf of the ASPIRE programme team

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

    a longitudinal process evaluation

    2022  Volume 24

    Abstract: Abstract Background Implementing evidence-based recommendations is challenging in UK primary care, especially given system pressures and multiple guideline recommendations competing for attention. Implementation packages that can be adapted and hence ... ...

    Abstract Abstract Background Implementing evidence-based recommendations is challenging in UK primary care, especially given system pressures and multiple guideline recommendations competing for attention. Implementation packages that can be adapted and hence applied to target multiple guideline recommendations could offer efficiencies for recommendations with common barriers to achievement. We developed and evaluated a package of evidence-based interventions (audit and feedback, educational outreach and reminders) incorporating behaviour change techniques to target common barriers, in two pragmatic trials for four “high impact” indicators: risky prescribing; diabetes control; blood pressure control; and anticoagulation in atrial fibrillation. We observed a significant, cost-effective reduction in risky prescribing but there was insufficient evidence of effect on the other outcomes. We explored the impact of the implementation package on both social processes (Normalisation Process Theory; NPT) and hypothesised determinants of behaviour (Theoretical Domains Framework; TDF). Methods We conducted a prospective multi-method process evaluation. Observational, administrative and interview data collection and analyses in eight primary care practices were guided by NPT and TDF. Survey data from trial and process evaluation practices explored fidelity. Results We observed three main patterns of variation in how practices responded to the implementation package. First, in integration and achievement, the package “worked” when it was considered distinctive and feasible. Timely feedback directed at specific behaviours enabled continuous goal setting, action and review, which reinforced motivation and collective action. Second, impacts on team-based determinants were limited, particularly when the complexity of clinical actions impeded progress. Third, there were delivery delays and unintended consequences. Delays in scheduling outreach further reduced ownership and time for improvement. Repeated stagnant or declining feedback that ...
    Keywords Tailored intervention ; Adaptable implementation package ; Theoretical Domains Framework ; Normalization Process Theory ; Process evaluation ; Audit and feedback ; Medicine (General) ; R5-920
    Subject code 360
    Language English
    Publishing date 2022-01-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  7. Article ; Online: Refining and optimising a behavioural intervention to support endocrine therapy adherence (ROSETA) in UK women with breast cancer

    Samuel G Smith / David P French / Galina Velikova / Amanda Farrin / Robbie Foy / Nikki Rousseau / Daniel Howdon / Jane Clark / Michelle Collinson / Christopher D Graham / Rebecca Walwyn / Emma McNaught / Ellen Mason / Sophie M C Green / Rachel Ellison / Louise H Hall / Hollie Wilkes / Erin Raine / Jacqueline Buxton /
    Sally J L Moore / Catherine Parbutt

    BMJ Open, Vol 13, Iss

    protocol for a pilot fractional factorial trial

    2023  Volume 2

    Abstract: Introduction Women with breast cancer who do not adhere to adjuvant endocrine therapy (AET) have increased risks of mortality and recurrence. There are multiple barriers to AET adherence, including medication side-effects, beliefs about medication, ... ...

    Abstract Introduction Women with breast cancer who do not adhere to adjuvant endocrine therapy (AET) have increased risks of mortality and recurrence. There are multiple barriers to AET adherence, including medication side-effects, beliefs about medication, memory and psychological distress. We developed four intervention components, each targeting a different barrier. This pilot trial is part of the preparation phase of the Multiphase Optimisation Strategy, and aims to establish key trial parameters, establish intervention component adherence, establish availability and feasibility of outcome and process data, estimate variability in planned outcome measures and estimate cost of developing and delivering each intervention component.Methods and analysis The four intervention components are as follows: short message service text reminders (target: memory); a written information leaflet (target: medication beliefs); a guided self-help Acceptance and Commitment Therapy programme (target: psychological flexibility to reduce distress) and a self-management website (target: side-effect management). To evaluate the feasibility of recruitment, acceptability of the intervention components and the availability of outcome data, we will conduct a multisite, exploratory pilot trial using a 24-1 fractional factorial design, with a nested process evaluation. We will randomise 80 women with early-stage breast cancer who have been prescribed AET to one of eight experimental conditions. This will determine the combination of intervention components they receive, ranging from zero to four, with all conditions receiving usual care. Key outcomes of interest include medication adherence and quality of life. Progression to the optimisation phase will be based on predefined criteria for consent rates, patient adherence to intervention components and availability of medication adherence data.Ethics and dissemination The study was reviewed by the Wales Research Authority Research Ethics Committee 3 (21/WA/0322). Written informed consent will be ...
    Keywords Medicine ; R
    Subject code 170
    Language English
    Publishing date 2023-02-01T00:00:00Z
    Publisher BMJ Publishing Group
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  8. Article ; Online: Acceptability, fidelity and trial experience of four intervention components to support medication adherence in women with breast cancer

    Louise H. Hall / Sophie M.C. Green / David P. French / Nikki Rousseau / Michelle Collinson / Christopher D. Graham / Hollie Wilkes / Ellen Mason / Robbie Foy / Daniel Howdon / Jane Clark / Rebecca Walwyn / Erin Raine / Catherine Parbutt / Jacqueline Buxton / Rachel Ellison / Galina Velikova / Sally J. L. Moore / Samuel G. Smith /
    Amanda Farrin

    NIHR Open Research, Vol

    A process evaluation protocol for a pilot fractional factorial trial [version 2; peer review: 2 approved]

    2023  Volume 3

    Abstract: Background: The Refining and Optimising a behavioural intervention to Support Endocrine Therapy Adherence (ROSETA) programme has developed four intervention components aiming to improve medication adherence in women with early-stage breast cancer. These ... ...

    Abstract Background: The Refining and Optimising a behavioural intervention to Support Endocrine Therapy Adherence (ROSETA) programme has developed four intervention components aiming to improve medication adherence in women with early-stage breast cancer. These are (a) text messages, (b) information leaflet, (c) Acceptance and Commitment Therapy-based guided self-help (ACT), (d) side-effect management website. Guided by the Multiphase Optimisation Strategy, our pilot trial will use a fractional factorial design to evaluate the feasibility of undertaking a larger optimisation trial. The pilot will include a process evaluation to maximise learning regarding the fidelity and acceptability of the intervention components before proceeding with a larger trial. The trial process evaluation has three aims: to assess the (1) fidelity and (2) acceptability of the intervention components; and (3) to understand participant’s trial experience, and barriers and facilitators to recruitment and retention. Methods: The process evaluation will use multiple methods. Fidelity of the intervention components will be assessed using self-reported questionnaire data, trial data on intervention component adherence, and observations of the ACT sessions. Acceptability of the intervention components and trial experience will be explored using an acceptability questionnaire and interviews with patients and trial therapists. Trial experience will be assessed using a questionnaire and interviews with participants, while barriers and facilitators to recruitment and retention will be assessed using a questionnaire completed by research nurses and participant interviews. The pilot trial opened for recruitment on 20th May 2022 and was open at the time of submission. Conclusions: This process evaluation will provide information regarding whether the intervention components can be delivered with fidelity within a national healthcare setting and are acceptable to participants. We will also better understand participant experience in a pilot trial with a ...
    Keywords process evaluation ; intervention fidelity ; acceptability ; trial experience ; fractional factorial ; eng ; Medicine ; R
    Subject code 380
    Language English
    Publishing date 2023-04-01T00:00:00Z
    Publisher F1000 Research Ltd
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  9. Article ; Online: Measuring commissioners’ willingness-to-pay for community based childhood obesity prevention programmes using a discrete choice experiment

    Edward J. D. Webb / Elizabeth Stamp / Michelle Collinson / Amanda J. Farrin / June Stevens / Wendy Burton / Harry Rutter / Holly Schofield / Maria Bryant

    BMC Public Health, Vol 20, Iss 1, Pp 1-

    2020  Volume 11

    Abstract: Abstract Background In the UK, rates of childhood obesity remain high. Community based programmes for child obesity prevention are available to be commissioned by local authorities. However, there is a lack of evidence regarding how programmes are ... ...

    Abstract Abstract Background In the UK, rates of childhood obesity remain high. Community based programmes for child obesity prevention are available to be commissioned by local authorities. However, there is a lack of evidence regarding how programmes are commissioned and which attributes of programmes are valued most by commissioners. The aim of this study was to determine the factors that decision-makers prioritise when commissioning programmes that target childhood obesity prevention. Methods An online discrete choice experiment (DCE) was used to survey commissioners and decision makers in the UK to assess their willingness-to-pay for childhood obesity programmes. Results A total of 64 commissioners and other decision makers completed the DCE. The impact of programmes on behavioural outcomes was prioritised, with participants willing to pay an extra £16,600/year if average daily fruit and vegetable intake increased for each child by one additional portion. Participants also prioritised programmes that had greater number of parents fully completing them, and were willing to pay an extra £4810/year for every additional parent completing a programme. The number of parents enrolling in a programme (holding the number completing fixed) and hours of staff time required did not significantly influence choices. Conclusions Emphasis on high programme completion rates and success increasing children’s fruit and vegetable intake has potential to increase commissioning of community based obesity prevention programmes.
    Keywords Childhood obesity ; Parental education ; Discrete choice experiment ; Willingness-to-pay ; Service commissioners ; Public aspects of medicine ; RA1-1270
    Subject code 360
    Language English
    Publishing date 2020-10-01T00:00:00Z
    Publisher BMC
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  10. 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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