Publications by authors named "Amanda J Farrin"

39 Publications

A hypothesis test of feasibility for external pilot trials assessing recruitment, follow-up, and adherence rates.

Stat Med 2021 Jun 14. Epub 2021 Jun 14.

Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.

The power of a large clinical trial can be adversely affected by low recruitment, follow-up, and adherence rates. External pilot trials estimate these rates and use them, via prespecified decision rules, to determine if the definitive trial is feasible and should go ahead. There is little methodological research underpinning how these decision rules, or the sample size of the pilot, should be chosen. In this article we propose a hypothesis test of the feasibility of a definitive trial, to be applied to the external pilot data and used to make progression decisions. We quantify feasibility by the power of the planned trial, as a function of recruitment, follow-up, and adherence rates. We use this measure to define hypotheses to test in the pilot, propose a test statistic, and show how the error rates of this test can be calculated for the common scenario of a two-arm parallel group definitive trial with a single normally distributed primary endpoint. We use our method to redesign TIGA-CUB, an external pilot trial comparing a psychotherapy with treatment as usual for children with conduct disorders. We then extend our formulation to include using the pilot data to estimate the standard deviation of the primary endpoint and incorporate this into the progression decision.
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http://dx.doi.org/10.1002/sim.9091DOI Listing
June 2021

A non-randomised feasibility study of an intervention to optimise medicines at transitions of care for patients with heart failure.

Pilot Feasibility Stud 2021 Mar 26;7(1):85. Epub 2021 Mar 26.

NIHR Yorkshire and Humber Patient Safety Translational Research Centre. Bradford Institute for Health Research, Temple Bank House, Bradford, BD9 6RJ, UK.

Background: Heart failure affects 26 million people globally, and the optimal management of medicines is crucial for patients, particularly when their care is transferred between hospital and the community. Optimising clinical outcomes requires well-calibrated cross-organisational processes with staff and patients responding and adapting to medicines changes. The aim of this study was to assess the feasibility of implementing a complex intervention (the Medicines at Transitions Intervention; MaTI) co-designed by patients and healthcare staff. The purpose of the intervention was to optimise medicines management across the gaps between secondary and primary care when hospitals handover care. The study objectives were to (1) assess feasibility through meeting specified progression criteria to proceed to the trial, (2) assess if the intervention was acceptable to staff and patients, and (3) determine whether amendment or refinement would be needed to enhance the MaTI.

Methods: The feasibility of the MaTI was tested in three healthcare areas in the North of England between July and October 2017. Feasibility was measured and assessed through four agreed progression to trial criteria: (1) patient recruitment, (2) patient receipt of a medicines toolkit, (3) transfer of discharge information to community pharmacy, and (4) offer of a community pharmacy medicines review/discussion or medicines reconciliation. From the cardiology wards at each of the three NHS Acute Trusts (sites), 10 patients (aged ≥ 18 years) were recruited and introduced to the 'My Medicines Toolkit' (MMT). Patients were asked to identify their usual community pharmacy or nominate a pharmacy. Discharge information was transferred to the community pharmacy; pharmacists were asked to reconcile medicines and invited patients for a medicines use review (MUR) or discussion. At 1 month following discharge, all patients were sent three questionnaire sets: quality-of-life, healthcare utilisation, and a patient experience survey. In a purposive sample, 20 patients were invited to participate in a semi-structured interview about their experiences of the MaTI. Staff from hospital and primary care settings involved in patients' care were invited to participate in a semi-structured interview. Patient and staff interviews were analysed using Framework Analysis. Questionnaire completion rates were recorded and data were descriptively analysed.

Results: Thirty-one patients were recruited across three sites. Eighteen staff and 18 patients took part in interviews, and 19 patients returned questionnaire sets. All four progression to trial criteria were met. We identified barriers to patient engagement with the intervention in hospital, which were compounded by patients' focus on returning home. Some patients described not engaging in discussions with staff about medicines and lacking motivation to do so because they were preoccupied with returning home. Some patients were unable or unwilling to attend a community pharmacy in person for a medicines review. Roles and responsibilities for delivering the MaTI were different in the three sites, and staff reported variations in time spent on MaTI activities. Staff reported some work pressures and staff absences that limited the time they could spend talking to patients about their medicines. Clinical teams reported that recording a target dose for heart failure medicines in patient-held documentation was difficult as they did not always know the ideal or tolerable dose. The majority of patients reported receiving the patient-held documentation. More than two-thirds reported being offered a MUR by their community pharmacists.

Conclusions: Delivery of the Medicines at Transitions Intervention (MaTI) was feasible at all three sites, and progression to trial criteria were met. Refinements were found to be necessary to overcome identified barriers and strengthen delivery of all steps of the intervention. Necessary changes to the MaTI were identified along with amendments to the implementation plan for the subsequent trial. Future implementation needs to take into account the complexity of medicines management and adaptation to local context.
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http://dx.doi.org/10.1186/s40814-021-00819-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7995719PMC
March 2021

Bayesian design and analysis of external pilot trials for complex interventions.

Stat Med 2021 05 17;40(12):2877-2892. Epub 2021 Mar 17.

Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.

External pilot trials of complex interventions are used to help determine if and how a confirmatory trial should be undertaken, providing estimates of parameters such as recruitment, retention, and adherence rates. The decision to progress to the confirmatory trial is typically made by comparing these estimates to pre-specified thresholds known as progression criteria, although the statistical properties of such decision rules are rarely assessed. Such assessment is complicated by several methodological challenges, including the simultaneous evaluation of multiple endpoints, complex multi-level models, small sample sizes, and uncertainty in nuisance parameters. In response to these challenges, we describe a Bayesian approach to the design and analysis of external pilot trials. We show how progression decisions can be made by minimizing the expected value of a loss function, defined over the whole parameter space to allow for preferences and trade-offs between multiple parameters to be articulated and used in the decision-making process. The assessment of preferences is kept feasible by using a piecewise constant parametrization of the loss function, the parameters of which are chosen at the design stage to lead to desirable operating characteristics. We describe a flexible, yet computationally intensive, nested Monte Carlo algorithm for estimating operating characteristics. The method is used to revisit the design of an external pilot trial of a complex intervention designed to increase the physical activity of care home residents.
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http://dx.doi.org/10.1002/sim.8941DOI Listing
May 2021

Cluster randomised controlled feasibility study of HENRY: a community-based intervention aimed at reducing obesity rates in preschool children.

Pilot Feasibility Stud 2021 Feb 26;7(1):59. Epub 2021 Feb 26.

Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.

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 acceptable. Contamination was likely, though the impact of this on behaviour was unclear.

Conclusion: Our findings indicate that a cluster RCT of HENRY to assess its effect on childhood obesity prevention is feasible. This study has allowed us to design a pragmatic definitive trial with minimal bias, taking account of lessons learnt from conducting evaluation research in public health settings.

Trial Registration: ClinicalTrials.gov Identifier NCT03333733 registered 6th November 2017.
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http://dx.doi.org/10.1186/s40814-021-00798-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7908721PMC
February 2021

Efficient and flexible simulation-based sample size determination for clinical trials with multiple design parameters.

Stat Methods Med Res 2021 Mar 2;30(3):799-815. Epub 2020 Dec 2.

Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.

Simulation offers a simple and flexible way to estimate the power of a clinical trial when analytic formulae are not available. The computational burden of using simulation has, however, restricted its application to only the simplest of sample size determination problems, often minimising a single parameter (the overall sample size) subject to power being above a target level. We describe a general framework for solving simulation-based sample size determination problems with several design parameters over which to optimise and several conflicting criteria to be minimised. The method is based on an established global optimisation algorithm widely used in the design and analysis of computer experiments, using a non-parametric regression model as an approximation of the true underlying power function. The method is flexible, can be used for almost any problem for which power can be estimated using simulation, and can be implemented using existing statistical software packages. We illustrate its application to a sample size determination problem involving complex clustering structures, two primary endpoints and small sample considerations.
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http://dx.doi.org/10.1177/0962280220975790DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8008419PMC
March 2021

Improving the Safety and Continuity Of Medicines management at Transitions of care (ISCOMAT): protocol for a process evaluation of a cluster randomised control trial.

BMJ Open 2020 11 24;10(11):e040493. Epub 2020 Nov 24.

Wolfson Centre for Applied Health Research, Bradford, UK.

Introduction: A key priority for the UK National Health Service and patients is to ensure that medicines are used safely and effectively. However, medication changes are not always optimally communicated and implemented when patients transfer from hospital into community settings. Heart failure is a common reason for admission to hospital. Patients with heart failure have a high burden of morbidity, mortality and complex pharmacotherapeutic regimens. The Improving the Safety and Continuity Of Medicines management at Transitions of care programme comprises a cluster randomised controlled trial which will test the effectiveness of a complex behavioural intervention aimed at improving medications management at the interface between hospitals discharge and community care. We will conduct a rigorous process evaluation to inform interpretation of the trial findings, inform implementation of the intervention on a wider scale and aid dissemination of the intervention.

Methods And Analysis: The process evaluation will be conducted in six purposively selected intervention sites (ie, hospital trusts and associated community pharmacies) using a mixed-methods design. Fidelity and barriers/enablers of implementation of the Medicines at Transitions Intervention (MaTI) will be explored using observation, interviews (20 patients, 40 healthcare professionals), surveys and routine trial data collection on adherence to MaTI. A parallel mixed analysis will be applied. Qualitative data will be thematically analysed using Framework analysis and survey data will be analysed descriptively. Data will be synthesised, triangulated and mapped to the Consolidated Framework for Implementation Research where appropriate. The process evaluation commenced on June 2018 and is due to end on February 2021.

Ethics And Dissemination: Approved by Research Ethics Committee and the UK Health Research Authority REC: 18/YH/0017/IRAS: 231 431. Findings will be disseminated via academic and policy conferences, peer-reviewed publications and social media.

Trial Registration Number: ISRCTN66212970.
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http://dx.doi.org/10.1136/bmjopen-2020-040493DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7689064PMC
November 2020

Measuring commissioners' willingness-to-pay for community based childhood obesity prevention programmes using a discrete choice experiment.

BMC Public Health 2020 Oct 12;20(1):1535. Epub 2020 Oct 12.

Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.

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.
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http://dx.doi.org/10.1186/s12889-020-09576-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7549208PMC
October 2020

Effectiveness of Dementia Care Mapping™ to reduce agitation in care home residents with dementia: an open-cohort cluster randomised controlled trial.

Aging Ment Health 2021 Aug 13;25(8):1410-1423. Epub 2020 Apr 13.

Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.

Objectives: Agitation is common and problematic in care home residents with dementia. This study investigated the (cost)effectiveness of Dementia Care Mapping™ (DCM) for reducing agitation in this population.

Method: Pragmatic, cluster randomised controlled trial with cost-effectiveness analysis in 50 care homes, follow-up at 6 and 16 months and stratified randomisation to intervention ( = 31) and control ( = 19). Residents with dementia were recruited at baseline ( = 726) and 16 months ( = 261). Clusters were not blinded to allocation. Three DCM cycles were scheduled, delivered by two trained staff per home. Cycle one was supported by an external DCM expert. Agitation (Cohen-Mansfield Agitation Inventory (CMAI)) at 16 months was the primary outcome.

Results: DCM was not superior to control on any outcomes (cross-sectional sample  = 675: 287 control, 388 intervention). The adjusted mean CMAI score difference was -2.11 points (95% CI -4.66 to 0.44,  = 0.104, adjusted ICC control = 0, intervention 0.001). Sensitivity analyses supported the primary analysis. Incremental cost per unit improvement in CMAI and QALYs (intervention vs control) on closed-cohort baseline recruited sample ( = 726, 418 intervention, 308 control) was £289 and £60,627 respectively. Loss to follow-up at 16 months in the original cohort was 312/726 (43·0%) mainly (87·2%) due to deaths. Intervention dose was low with only a quarter of homes completing more than one DCM cycle.

Conclusion: No benefits of DCM were evidenced. Low intervention dose indicates standard care homes may be insufficiently resourced to implement DCM. Alternative models of implementation, or other approaches to reducing agitation should be considered.
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http://dx.doi.org/10.1080/13607863.2020.1745144DOI Listing
August 2021

Enabling people with dementia to access and receive cancer treatment and care: The crucial role of supportive networks.

J Geriatr Oncol 2020 09 4;11(7):1125-1131. Epub 2020 Apr 4.

Clinical Trials Research Unit, Institute of Clinical Trials Research, University of Leeds, Leeds, UK. Electronic address:

Objectives: Despite cancer and dementia being conditions in which prevalence increases with age, there remains limited research on the cancer treatment and care needs of this population. Our study aimed to address this gap and this paper reports on the role of supportive networks in enabling people with dementia to access cancer treatment and care.

Materials And Methods: An ethnographic study involving seventeen people with cancer and dementia, 22 relatives and nineteen oncology staff. It comprised observations (46 h) of and informal conversations during oncology appointments attended by people with dementia and their relatives and semi-structured interviews (n = 37) with people living with cancer and dementia, their relatives and staff working in various roles across oncology services. Data were analysed using thematic analysis.

Results: Patients and oncology staff relied on and expected relatives to provide practical and emotional support around cancer treatment and care. Families varied in their ability to provide required support due to extent of the family network, practical issues, knowledge of the patient and their wishes, family conflict and the patient's willingness to accept help. Where no family network was available, support provision was complex and this could compromise access to cancer treatment.

Conclusions: People with comorbid cancer and dementia rely heavily on a supportive family network to access treatment and care. Oncology services need to assess the supportive networks available to individual patients in developing cancer treatment plans. Urgent consideration needs to be given to how those with no family networks can be appropriately supported.
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http://dx.doi.org/10.1016/j.jgo.2020.03.015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7544010PMC
September 2020

Dementia Care Mapping™ to reduce agitation in care home residents with dementia: the EPIC cluster RCT.

Health Technol Assess 2020 03;24(16):1-172

Clinical Trials Research Unit, University of Leeds, Leeds, UK.

Background: The quality of care for people with dementia in care homes is of concern. Interventions that can improve care outcomes are required.

Objective: To investigate the clinical effectiveness and cost-effectiveness of Dementia Care Mapping™ (DCM) for reducing agitation and improving care outcomes for people living with dementia in care homes, versus usual care.

Design: A pragmatic, cluster randomised controlled trial with an open-cohort design, follow-up at 6 and 16 months, integrated cost-effectiveness analysis and process evaluation. Clusters were not blinded to allocation. The primary end point was completed by staff proxy and independent assessors.

Setting: Stratified randomisation of 50 care homes to the intervention and control groups on a 3 : 2 ratio by type, size, staff exposure to dementia training and recruiting hub.

Participants: Fifty care homes were randomised (intervention,  = 31; control,  = 19), with 726 residents recruited at baseline and a further 261 recruited after 16 months. Care homes were eligible if they recruited a minimum of 10 residents, were not subject to improvement notices, had not used DCM in the previous 18 months and were not participating in conflicting research. Residents were eligible if they lived there permanently, had a formal diagnosis of dementia or a score of 4+ on the Functional Assessment Staging Test of Alzheimer's Disease, were proficient in English and were not terminally ill or permanently cared for in bed. All homes were audited on the delivery of dementia and person-centred care awareness training. Those not reaching a minimum standard were provided training ahead of randomisation. Eighteen homes took part in the process evaluation.

Intervention: Two staff members from each intervention home were trained to use DCM and were asked to carry out three DCM cycles; the first was supported by an external expert.

Main Outcome Measures: The primary outcome was agitation (Cohen-Mansfield Agitation Inventory), measured at 16 months. Secondary outcomes included resident behaviours and quality of life.

Results: There were 675 residents in the final analysis (intervention,  = 388; control,  = 287). There was no evidence of a difference in agitation levels between the treatment arms. The adjusted mean difference in Cohen-Mansfield Agitation Inventory score was -2.11 points, being lower in the intervention group than in the control (95% confidence interval -4.66 to 0.44;  = 0.104; adjusted intracluster correlation coefficient: control = 0, intervention = 0.001). The sensitivity analyses results supported the primary analysis. No differences were detected in any of the secondary outcomes. The health economic analyses indicated that DCM was not cost-effective. Intervention adherence was problematic; only 26% of homes completed more than their first DCM cycle. Impacts, barriers to and facilitators of DCM implementation were identified.

Limitations: The primary completion of resident outcomes was by staff proxy, owing to self-report difficulties for residents with advanced dementia. Clusters were not blinded to allocation, although supportive analyses suggested that any reporting bias was not clinically important.

Conclusions: There was no benefit of DCM over control for any outcomes. The implementation of DCM by care home staff was suboptimal compared with the protocol in the majority of homes.

Future Work: Alternative models of DCM implementation should be considered that do not rely solely on leadership by care home staff.

Trial Registration: Current Controlled Trials ISRCTN82288852.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 24, No. 16. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta24160DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7132533PMC
March 2020

An adaptable implementation package targeting evidence-based indicators in primary care: A pragmatic cluster-randomised evaluation.

PLoS Med 2020 02 28;17(2):e1003045. Epub 2020 Feb 28.

Leeds Institute of Health Sciences, University of Leeds, Leeds, United Kingdom.

Background: In primary care, multiple priorities and system pressures make closing the gap between evidence and practice challenging. Most implementation studies focus on single conditions, limiting generalisability. We compared an adaptable implementation package against an implementation control and assessed effects on adherence to four different evidence-based quality indicators.

Methods And Findings: We undertook two parallel, pragmatic cluster-randomised trials using balanced incomplete block designs in general practices in West Yorkshire, England. We used 'opt-out' recruitment, and we randomly assigned practices that did not opt out to an implementation package targeting either diabetes control or risky prescribing (Trial 1); or blood pressure (BP) control or anticoagulation in atrial fibrillation (AF) (Trial 2). Within trials, each arm acted as the implementation control comparison for the other targeted indicator. For example, practices assigned to the diabetes control package acted as the comparison for practices assigned to the risky prescribing package. The implementation package embedded behaviour change techniques within audit and feedback, educational outreach, and computerised support, with content tailored to each indicator. Respective patient-level primary endpoints at 11 months comprised the following: achievement of all recommended levels of haemoglobin A1c (HbA1c), BP, and cholesterol; risky prescribing levels; achievement of recommended BP; and anticoagulation prescribing. Between February and March 2015, we recruited 144 general practices collectively serving over 1 million patients. We stratified computer-generated randomisation by area, list size, and pre-intervention outcome achievement. In April 2015, we randomised 80 practices to Trial 1 (40 per arm) and 64 to Trial 2 (32 per arm). Practices and trial personnel were not blind to allocation. Two practices were lost to follow-up but provided some outcome data. We analysed the intention-to-treat (ITT) population, adjusted for potential confounders at patient level (sex, age) and practice level (list size, locality, pre-intervention achievement against primary outcomes, total quality scores, and levels of patient co-morbidity), and analysed cost-effectiveness. The implementation package reduced risky prescribing (odds ratio [OR] 0.82; 97.5% confidence interval [CI] 0.67-0.99, p = 0.017) with an incremental cost-effectiveness ratio of £1,359 per quality-adjusted life year (QALY), but there was insufficient evidence of effect on other primary endpoints (diabetes control OR 1.03, 97.5% CI 0.89-1.18, p = 0.693; BP control OR 1.05, 97.5% CI 0.96-1.16, p = 0.215; anticoagulation prescribing OR 0.90, 97.5% CI 0.75-1.09, p = 0.214). No statistically significant effects were observed in any secondary outcome except for reduced co-prescription of aspirin and clopidogrel without gastro-protection in patients aged 65 and over (adjusted OR 0.62; 97.5% CI 0.39-0.99; p = 0.021). Main study limitations concern our inability to make any inferences about the relative effects of individual intervention components, given the multifaceted nature of the implementation package, and that the composite endpoint for diabetes control may have been too challenging to achieve.

Conclusions: In this study, we observed that a multifaceted implementation package was clinically and cost-effective for targeting prescribing behaviours within the control of clinicians but not for more complex behaviours that also required patient engagement.

Trial Registration: The study is registered with the ISRCTN registry (ISRCTN91989345).
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http://dx.doi.org/10.1371/journal.pmed.1003045DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7048270PMC
February 2020

Safety and efficacy of co-careldopa as an add-on therapy to occupational and physical therapy in patients after stroke (DARS): a randomised, double-blind, placebo-controlled trial.

Lancet Neurol 2019 06;18(6):530-538

Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.

Background: Dopamine is a key modulator of striatal function and learning and might improve motor recovery after stroke. Previous small trials of dopamine agonists after stroke provide equivocal evidence of effectiveness on improving motor recovery. We aimed to assess the safety and efficacy of co-careldopa plus routine occupational and physical therapy during early rehabilitation after stroke.

Methods: This double-blind, multicentre, randomised controlled trial of co-careldopa versus placebo in addition to routine NHS occupational and physical therapy was done at 51 UK NHS acute inpatient stroke rehabilitation services. We recruited patients with new or recurrent clinically diagnosed ischaemic or haemorrhagic (excluding subarachnoid haemorrhage) stroke 5-42 days before randomisation, who were unable to walk 10 m or more, had a score of less than 7 points on the Rivermead Mobility Index, were expected to need rehabilitation, and were able to access rehabilitation after discharge from hospital. Participants were assigned (1:1) using stratified random blocks to receive 6 weeks of oral co-careldopa or matched placebo in addition to routine NHS physiotherapy and occupational therapy. The initial two doses of co-careldopa were 62·5 mg (50 mg of levodopa and 12·5 mg of carbidopa) and the remaining doses were 125 mg (100 mg of levodopa and 25 mg of carbidopa). Participants were required to take a single oral tablet 45-60 min before physiotherapy or occupational therapy session. The primary outcome was ability to walk independently, defined as a Rivermead Mobility Index score of 7 or more, at 8 weeks. Primary and safety analyses were done in the intention-to-treat population. The trial is registered on the ISRCTN registry, number ISRCTN99643613.

Findings: Between May 30, 2011, and March 28, 2014, of 1574 patients found eligible, 593 (mean age 68·5 years) were randomly assigned to either the co-careldopa group (n=308) or to the placebo group (n=285), on an average 18 days after stroke onset. Primary outcome data were available for all 593 patients. We found no evidence that the ability to walk independently improved with co-careldopa (125 [41%] of 308 patients) compared with placebo (127 [45%] of 285 patients; odds ratio 0·78 [95% CI 0·53-1·15]) at 8 weeks. Mortality at 12 months did not differ between the two groups (22 [7%] vs 17 [6%]). Serious adverse events were largely similar between groups. Vomiting during therapy sessions, after taking the study drug, was the most frequent adverse event and was more frequent in the co-careldopa group than the placebo group (19 [6·2%] vs 9 [3·2%]).

Interpretation: Co-careldopa in addition to routine occupational and physical therapy does not seem to improve walking after stroke. Further research might identify subgroups of patients with stroke who could benefit from dopaminergic therapy at different doses or times after stroke with more intensive motor therapy.

Funding: Medical Research Council.
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http://dx.doi.org/10.1016/S1474-4422(19)30147-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6527868PMC
June 2019

The Implementation of Dementia Care Mapping in a Randomized Controlled Trial in Long-Term Care: Results of a Process Evaluation.

Am J Alzheimers Dis Other Demen 2019 09 5;34(6):390-398. Epub 2019 May 5.

2 Clinical Trials Research Unit, University of Leeds, Leeds, United Kingdom.

This study explored intervention implementation within a pragmatic, cluster randomized controlled trial of Dementia Care Mapping™ (DCM) in UK care homes. DCM is a practice development tool comprised of a 5 component cycle (staff briefing, mapping observations, data analysis and reporting, staff feedback, and action planning) that supports delivery of person-centered care. Two staff from the 31 intervention care homes were trained in DCM and asked to deliver 3 cycles over a 15-month period, supported by a DCM expert during cycle 1. Implementation data were collected after each mapping cycle. There was considerable variability in DCM implementation fidelity, dose, and reach. Not all homes trained 2 mappers on schedule, and some found it difficult to retain mappers. Only 26% of homes completed more than 1 cycle. Future DCM trials in care home settings should consider additional methods to support intervention completion including intervention delivery being conducted with ongoing external support.
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http://dx.doi.org/10.1177/1533317519845725DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6676338PMC
September 2019

An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for the process evaluation of a cluster randomised controlled feasibility trial.

Trials 2018 Jul 11;19(1):368. Epub 2018 Jul 11.

Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.

Background: Whilst pathways relating to the early stages of stroke care have become well established, strategies for longer-term care are less developed and longer-term outcomes remain poor for many stroke survivors. New Start, a complex intervention that includes needs identification, exploration of social networks and components of problem-solving and self-management, was designed to improve stroke survivors' quality of life by addressing unmet needs and increasing participation. It is delivered approximately 6 months post-stroke by trained staff (facilitators). We are currently undertaking a cluster randomised feasibility trial of the New Start intervention with an embedded process evaluation, which is an important component of the design and testing of complex interventions as it provides an understanding of how interventions are delivered and function in different settings.

Methods/design: This mixed methods process evaluation will explore the degree to which New Start is implemented as intended, the impact of context on intervention delivery and the acceptability of the intervention for stroke survivors, their families and practitioners. It will include non-participant observation of facilitator training and intervention delivery. Interviews with stroke survivors, facilitators and other relevant staff (including administrators and managerial staff) will be undertaken. Qualitative data from interview transcripts, facilitator reflections and observational field notes will be analysed thematically alongside numerical data documenting intervention delivery collected as part of the trial.

Discussion: This process evaluation will identify factors that aid and impede implementation of the New Start intervention and improve understanding of this novel approach to longer-term stroke care.

Trial Registration: ISRCTN Registry, ISRCTN38920246 . Registered on 22 June 2016.
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http://dx.doi.org/10.1186/s13063-018-2683-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6042238PMC
July 2018

Cluster randomised controlled feasibility study of HENRY: a community-based intervention aimed at reducing obesity rates in preschool children.

Pilot Feasibility Stud 2018 21;4:118. Epub 2018 Jun 21.

1Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT UK.

Background: In the UK and beyond, public funding is used to commission interventions delivered in public health early years settings aimed at improving health and well-being and reducing inequalities in order to promote school readiness. This is a key setting for obesity prevention programmes, which are often commissioned despite the limited evidence base. The HENRY (Health, Exercise, Nutrition for the Really Young) programme is an 8-week programme delivered to parents of preschool children, designed to support families to optimise healthy weight behaviours. Early evidence suggests that it may be effective, but a robust evaluation using a randomised controlled design has not been conducted. This study begins this process by evaluating the feasibility of conducting a multi-centre definitive trial to evaluate the effectiveness and cost-effectiveness of HENRY to prevent obesity in the early years.

Methods: This is a multi-centre, open labelled, two group, prospective, cluster randomised, controlled, feasibility study aiming to recruit 120 parents from 12 children's centres, based in two local authority areas. Within each of the two local authorities, three centres will be randomised to HENRY and three will be randomised to a control arm of standard care (usual provision of services within children's centres). We will explore HENRY commissioning, provision and delivery and assess the feasibility of local authority, centre and parent recruitment, the processes and time required to train and certify staff to deliver the intervention, the potential sources (and associated risk) of contamination and the feasibility of the trial procedures. Research includes a process evaluation, feasibility of cost-effectiveness evaluation, with progression to the definitive trial judged against pre-defined criteria.

Discussion: This feasibility study will support the decision to proceed to, and the design of, a future definitive trial, providing an evidence base of an approach to prevent childhood obesity, which has been deemed attractive to all stakeholders, including parents. Given the widespread adoption of the intervention, this has the potential to impact on public health in the UK and beyond.

Trial Registration: ClinicalTrials.gov Identifier NCT03333733 registered 6th November 2017Protocol date: 25th October 2017Protocol version: 4.0.
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http://dx.doi.org/10.1186/s40814-018-0309-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6013860PMC
June 2018

Developing and feasibility testing of data collection methods for an economic evaluation of a supported selfmanagement programme for adults with a learning disability and type 2 diabetes.

Pilot Feasibility Stud 2018 23;4:80. Epub 2018 Apr 23.

1Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Worsley Building, Leeds, LS2 9NL UK.

Background: The challenges of conducting research with hard to reach vulnerable groups are particularly pertinent for people with learning disabilities. Data collection methods for previous cost and cost-effectiveness analyses of health and social care interventions targeting people with learning disabilities have relied on health care/health insurance records or data collection forms completed by the service provider rather than by people with learning disabilities themselves. This paper reports on the development and testing of data collection methods for an economic evaluation within a randomised controlled trial (RCT) for a supported self-management programme for people with mild/moderate learning disabilities and type 2 diabetes.

Methods: A case finding study was conducted to identify types of health and social care use and data collection methods employed in previous studies with this population. Based on this evidence, resource use questionnaires for completion by GP staff and interviewer-administered participant questionnaires (covering a wider cost perspective and health-related quality of life) were tested within a feasibility RCT. Interviewer-administered questionnaires included the EQ-5D-3L (the NICE recommended measure for use in economic evaluation). Participants were adults > 18 years with a mild or moderate learning disability and type 2 diabetes, with mental capacity to give consent to research participation.

Results: Data collection for questionnaires completed by GP staff requesting data for the last 12 months proved time intensive and difficult. Whilst 82.3% (121/147) of questionnaires were returned, up to 17% of service use items were recorded as unknown. Subsequently, a shorter recall period (4 months) led to a higher return rate but with a higher rate of missing data. Missing data for interviewer-administered participant questionnaires was > 8% but the interviewers reported difficulty with participant recall. Almost 60% (48/80) of participants had difficulty completing the EQ-5D-3L.

Conclusions: Further investigation as to how service use can be recorded is recommended. Concerns about the reliability of identifying service use data directly from participants with a learning disability due to challenges in completion, specifically around recall, remain. The degree of difficulty to complete EQ-5D-3L indicates concerns regarding the appropriateness of using this measure in its current form in research with this population.

Trial Registration: Current Controlled Trials ISRCTN41897033 (registered 21 January 2013).
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http://dx.doi.org/10.1186/s40814-018-0266-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5911950PMC
April 2018

A pragmatic randomised controlled trial and economic evaluation of family therapy versus treatment as usual for young people seen after second or subsequent episodes of self-harm: the Self-Harm Intervention - Family Therapy (SHIFT) trial.

Health Technol Assess 2018 03;22(12):1-222

Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.

Background: Self-harm in adolescents is common and repetition rates high. There is limited evidence of the effectiveness of interventions to reduce self-harm.

Objectives: To assess the clinical effectiveness and cost-effectiveness of family therapy (FT) compared with treatment as usual (TAU).

Design: A pragmatic, multicentre, individually randomised controlled trial of FT compared with TAU. Participants and therapists were aware of treatment allocation; researchers were blind to allocation.

Setting: Child and Adolescent Mental Health Services (CAMHS) across three English regions.

Participants: Young people aged 11-17 years who had self-harmed at least twice presenting to CAMHS following self-harm.

Interventions: Eight hundred and thirty-two participants were randomised to manualised FT delivered by trained and supervised family therapists ( = 415) or to usual care offered by local CAMHS following self-harm ( = 417).

Main Outcome Measures: Rates of repetition of self-harm leading to hospital attendance 18 months after randomisation.

Results: Out of 832 young people, 212 (26.6%) experienced a primary outcome event: 118 out of 415 (28.4%) randomised to FT and 103 out of 417 (24.7%) randomised to TAU. There was no evidence of a statistically significant difference in repetition rates between groups (the hazard ratio for FT compared with TAU was 1.14, 95% confidence interval 0.87 to 1.49;  = 0.3349). FT was not found to be cost-effective when compared with TAU in the base case and most sensitivity analyses. FT was dominated (less effective and more expensive) in the complete case. However, when young people's and caregivers' quality-adjusted life-year gains were combined, FT incurred higher costs and resulted in better health outcomes than TAU within the National Institute for Health and Care Excellence cost-effectiveness range. Significant interactions with treatment, indicating moderation, were detected for the unemotional subscale on the young person-reported Inventory of Callous-Unemotional Traits ( = 0.0104) and the affective involvement subscale on the caregiver-reported McMaster Family Assessment Device ( = 0.0338). Caregivers and young people in the FT arm reported a range of significantly better outcomes on the Strengths and Difficulties Questionnaire. Self-reported suicidal ideation was significantly lower in the FT arm at 12 months but the same in both groups at 18 months. No significant unexpected adverse events or side effects were reported, with similar rates of expected adverse events across trial arms.

Conclusions: For adolescents referred to CAMHS after self-harm, who have self-harmed at least once before, FT confers no benefits over TAU in reducing self-harm repetition rates. There is some evidence to support the effectiveness of FT in reducing self-harm when caregivers reported poor family functioning. When the young person themselves reported difficulty expressing emotion, FT did not seem as effective as TAU. There was no evidence that FT is cost-effective when only the health benefits to participants were considered but there was a suggestion that FT may be cost-effective if health benefits to caregivers are taken into account. FT had a significant, positive impact on general emotional and behavioural problems at 12 and 18 months.

Limitations: There was significant loss to follow-up for secondary outcomes and health economic analyses; the primary outcome misses those who do not attend hospital following self-harm; and the numbers receiving formal FT in the TAU arm were higher than expected.

Future Work: Evaluation of interventions targeted at subgroups of those who self-harm, longer-term follow-up and methods for evaluating health benefits for family groups rather than for individuals.

Trial Registration: Current Controlled Trials ISRCTN59793150.

Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in ; Vol. 22, No. 12. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta22120DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5867393PMC
March 2018

To what extent can behaviour change techniques be identified within an adaptable implementation package for primary care? A prospective directed content analysis.

Implement Sci 2018 02 17;13(1):32. Epub 2018 Feb 17.

Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.

Background: Interpreting evaluations of complex interventions can be difficult without sufficient description of key intervention content. We aimed to develop an implementation package for primary care which could be delivered using typically available resources and could be adapted to target determinants of behaviour for each of four quality indicators: diabetes control, blood pressure control, anticoagulation for atrial fibrillation and risky prescribing. We describe the development and prospective verification of behaviour change techniques (BCTs) embedded within the adaptable implementation packages.

Methods: We used an over-lapping multi-staged process. We identified evidence-based, candidate delivery mechanisms-mainly audit and feedback, educational outreach and computerised prompts and reminders. We drew upon interviews with primary care professionals using the Theoretical Domains Framework to explore likely determinants of adherence to quality indicators. We linked determinants to candidate BCTs. With input from stakeholder panels, we prioritised likely determinants and intervention content prior to piloting the implementation packages. Our content analysis assessed the extent to which embedded BCTs could be identified within the packages and compared them across the delivery mechanisms and four quality indicators.

Results: Each implementation package included at least 27 out of 30 potentially applicable BCTs representing 15 of 16 BCT categories. Whilst 23 BCTs were shared across all four implementation packages (e.g. BCTs relating to feedback and comparing behaviour), some BCTs were unique to certain delivery mechanisms (e.g. 'graded tasks' and 'problem solving' for educational outreach). BCTs addressing the determinants 'environmental context' and 'social and professional roles' (e.g. 'restructuring the social and 'physical environment' and 'adding objects to the environment') were indicator specific. We found it challenging to operationalise BCTs targeting 'environmental context', 'social influences' and 'social and professional roles' within our chosen delivery mechanisms.

Conclusion: We have demonstrated a transparent process for selecting, operationalising and verifying the BCT content in implementation packages adapted to target four quality indicators in primary care. There was considerable overlap in BCTs identified across the four indicators suggesting core BCTs can be embedded and verified within delivery mechanisms commonly available to primary care. Whilst feedback reports can include a wide range of BCTs, computerised prompts can deliver BCTs at the time of decision making, and educational outreach can allow for flexibility and individual tailoring in delivery.
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http://dx.doi.org/10.1186/s13012-017-0704-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5816358PMC
February 2018

Effectiveness of systemic family therapy versus treatment as usual for young people after self-harm: a pragmatic, phase 3, multicentre, randomised controlled trial.

Lancet Psychiatry 2018 03 12;5(3):203-216. Epub 2018 Feb 12.

Clinical Trials Research Unit, University of Leeds, Leeds, UK.

Background: Self-harm in adolescents is common and repetition occurs in a high proportion of these cases. Scarce evidence exists for effectiveness of interventions to reduce self-harm.

Methods: This pragmatic, multicentre, randomised, controlled trial of family therapy versus treatment as usual was done at 40 UK Child and Adolescent Mental Health Services (CAMHS) centres. We recruited young people aged 11-17 years who had self-harmed at least twice and presented to CAMHS after self-harm. Participants were randomly assigned (1:1) to receive manualised family therapy delivered by trained and supervised family therapists or treatment as usual by local CAMHS. Participants and therapists were aware of treatment allocation; researchers were masked. The primary outcome was hospital attendance for repetition of self-harm in the 18 months after group assignment. Primary and safety analyses were done in the intention-to-treat population. The trial is registered at the ISRCTN registry, number ISRCTN59793150.

Findings: Between Nov 23, 2009, and Dec 31, 2013, 3554 young people were screened and 832 eligible young people consented to participation and were randomly assigned to receive family therapy (n=415) or treatment as usual (n=417). Primary outcome data were available for 795 (96%) participants. Numbers of hospital attendances for repeat self-harm events were not significantly different between the groups (118 [28%] in the family therapy group vs 103 [25%] in the treatment as usual group; hazard ratio 1·14 [95% CI 0·87-1·49] p=0·33). Similar numbers of adverse events occurred in both groups (787 in the family therapy group vs 847 in the treatment as usual group).

Interpretation: For adolescents referred to CAMHS after self-harm, having self-harmed at least once before, our family therapy intervention conferred no benefits over treatment as usual in reducing subsequent hospital attendance for self-harm. Clinicians are therefore still unable to recommend a clear, evidence-based intervention to reduce repeated self-harm in adolescents.

Funding: National Institute for Health Research Health Technology Assessment programme.
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http://dx.doi.org/10.1016/S2215-0366(18)30058-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5835764PMC
March 2018

Improving the Development, Monitoring and Reporting of Stroke Rehabilitation Research: Consensus-Based Core Recommendations from the Stroke Recovery and Rehabilitation Roundtable.

Neurorehabil Neural Repair 2017 Oct-Nov;31(10-11):877-884

11 University of Central Lancashire, Preston, UK and Australian Catholic University, Sydney, Australia.

Recent reviews have demonstrated that the quality of stroke rehabilitation research has continued to improve over the last four decades but despite this progress, there are still many barriers in moving the field forward. Rigorous development, monitoring and complete reporting of interventions in stroke trials are essential in providing rehabilitation evidence that is robust, meaningful and implementable. An international partnership of stroke rehabilitation experts committed to develop consensus-based core recommendations with a remit of addressing the issues identified as limiting stroke rehabilitation research in the areas of developing, monitoring and reporting stroke rehabilitation interventions. Work exploring each of the three areas took place via multiple teleconferences and a two-day meeting in Philadelphia in May 2016. A total of 15 recommendations were made. To validate the need for the recommendations, the group reviewed all stroke rehabilitation trials published in 2015 (n=182 papers). Our review highlighted that the majority of publications did not clearly describe how interventions were developed or monitored during the trial. In particular, under-reporting of the theoretical rationale for the intervention and the components of the intervention call into question many interventions that have been evaluated for efficacy. More trials were found to have addressed the reporting of interventions recommendations than those related to development or monitoring. Nonetheless, the majority of reporting recommendations were still not adequately described. To progress the field of stroke rehabilitation research and to ensure stroke patients receive optimal evidence-based clinical care, we urge the research community to endorse and adopt our recommendations.
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http://dx.doi.org/10.1177/1545968317732686DOI Listing
July 2018

Improving the development, monitoring and reporting of stroke rehabilitation research: Consensus-based core recommendations from the Stroke Recovery and Rehabilitation Roundtable.

Int J Stroke 2017 07;12(5):472-479

11 University of Central Lancashire, Preston, UK and Australian Catholic University, Sydney, Australia.

Recent reviews have demonstrated that the quality of stroke rehabilitation research has continued to improve over the last four decades but despite this progress, there are still many barriers in moving the field forward. Rigorous development, monitoring and complete reporting of interventions in stroke trials are essential in providing rehabilitation evidence that is robust, meaningful and implementable. An international partnership of stroke rehabilitation experts committed to develop consensus-based core recommendations with a remit of addressing the issues identified as limiting stroke rehabilitation research in the areas of developing, monitoring and reporting stroke rehabilitation interventions. Work exploring each of the three areas took place via multiple teleconferences and a two-day meeting in Philadelphia in May 2016. A total of 15 recommendations were made. To validate the need for the recommendations, the group reviewed all stroke rehabilitation trials published in 2015 (n = 182 papers). Our review highlighted that the majority of publications did not clearly describe how interventions were developed or monitored during the trial. In particular, under-reporting of the theoretical rationale for the intervention and the components of the intervention call into question many interventions that have been evaluated for efficacy. More trials were found to have addressed the reporting of interventions recommendations than those related to development or monitoring. Nonetheless, the majority of reporting recommendations were still not adequately described. To progress the field of stroke rehabilitation research and to ensure stroke patients receive optimal evidence-based clinical care, we urge the research community to endorse and adopt our recommendations.
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July 2017

The evaluation of enhanced feedback interventions to reduce unnecessary blood transfusions (AFFINITIE): protocol for two linked cluster randomised factorial controlled trials.

Implement Sci 2017 07 3;12(1):84. Epub 2017 Jul 3.

Transfusion Medicine, NHS Blood and Transplant, Oxford, UK.

Background: Blood for transfusion is a frequently used clinical intervention, and is also a costly and limited resource with risks. Many transfusions are given to stable and non-bleeding patients despite no clear evidence of benefit from clinical studies. Audit and feedback (A&F) is widely used to improve the quality of healthcare, including appropriate use of blood. However, its effects are often inconsistent, indicating the need for coordinated research including more head-to-head trials comparing different ways of delivering feedback. A programmatic series of research projects, termed the 'Audit and Feedback INterventions to Increase evidence-based Transfusion practIcE' (AFFINITIE) programme, aims to test different ways of developing and delivering feedback within an existing national audit structure.

Methods: The evaluation will comprise two linked 2×2 factorial, cross-sectional cluster-randomised controlled trials. Each trial will estimate the effects of two feedback interventions, 'enhanced content' and 'enhanced follow-on support', designed in earlier stages of the AFFINITIE programme, compared to current practice. The interventions will be embedded within two rounds of the UK National Comparative Audit of Blood Transfusion (NCABT) focusing on patient blood management in surgery and use of blood transfusions in patients with haematological malignancies. The unit of randomisation will be National Health Service (NHS) trust or health board. Clusters providing care relevant to the audit topics will be randomised following each baseline audit (separately for each trial), with stratification for size (volume of blood transfusions) and region (Regional Transfusion Committee). The primary outcome for each topic will be the proportion of patients receiving a transfusion coded as unnecessary. For each audit topic a linked, mixed-method fidelity assessment and cost-effectiveness analysis will be conducted in parallel to the trial.

Discussion: AFFINITIE involves a series of studies to explore how A&F may be refined to change practice including two cluster randomised trials linked to national audits of transfusion practice. The methodology represents a step-wise increment in study design to more fully evaluate the effects of two enhanced feedback interventions on patient- and trust-level clinical, cost, safety and process outcomes.

Trial Registration: http://www.isrctn.com/ISRCTN15490813.
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http://dx.doi.org/10.1186/s13012-017-0614-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5496161PMC
July 2017

Effectiveness of an implementation optimisation intervention aimed at increasing parent engagement in HENRY, a childhood obesity prevention programme - the Optimising Family Engagement in HENRY (OFTEN) trial: study protocol for a randomised controlled trial.

Trials 2017 01 24;18(1):40. Epub 2017 Jan 24.

Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS29JT, UK.

Background: Family-based interventions to prevent childhood obesity depend upon parents' taking action to improve diet and other lifestyle behaviours in their families. Programmes that attract and retain high numbers of parents provide an enhanced opportunity to improve public health and are also likely to be more cost-effective than those that do not. We have developed a theory-informed optimisation intervention to promote parent engagement within an existing childhood obesity prevention group programme, HENRY (Health Exercise Nutrition for the Really Young). Here, we describe a proposal to evaluate the effectiveness of this optimisation intervention in regard to the engagement of parents and cost-effectiveness.

Methods/design: The Optimising Family Engagement in HENRY (OFTEN) trial is a cluster randomised controlled trial being conducted across 24 local authorities (approximately 144 children's centres) which currently deliver HENRY programmes. The primary outcome will be parental enrolment and attendance at the HENRY programme, assessed using routinely collected process data. Cost-effectiveness will be presented in terms of primary outcomes using acceptability curves and through eliciting the willingness to pay for the optimisation from HENRY commissioners. Secondary outcomes include the longitudinal impact of the optimisation, parent-reported infant intake of fruits and vegetables (as a proxy to compliance) and other parent-reported family habits and lifestyle.

Discussion: This innovative trial will provide evidence on the implementation of a theory-informed optimisation intervention to promote parent engagement in HENRY, a community-based childhood obesity prevention programme. The findings will be generalisable to other interventions delivered to parents in other community-based environments. This research meets the expressed needs of commissioners, children's centres and parents to optimise the potential impact that HENRY has on obesity prevention. A subsequent cluster randomised controlled pilot trial is planned to determine the practicality of undertaking a definitive trial to robustly evaluate the effectiveness and cost-effectiveness of the optimised intervention on childhood obesity prevention.

Trial Registration: ClinicalTrials.gov identifier: NCT02675699 . Registered on 4 February 2016.
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http://dx.doi.org/10.1186/s13063-016-1732-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5260000PMC
January 2017

Evaluating the effectiveness and cost-effectiveness of Dementia Care Mapping™ to enable person-centred care for people with dementia and their carers (DCM-EPIC) in care homes: study protocol for a randomised controlled trial.

Trials 2016 06 24;17(1):300. Epub 2016 Jun 24.

School of Dementia Studies, University of Bradford, Bradford, BD7 1DP, UK.

Background: Up to 90 % of people living with dementia in care homes experience one or more behaviours that staff may describe as challenging to support (BSC). Of these agitation is the most common and difficult to manage. The presence of agitation is associated with fewer visits from relatives, poorer quality of life and social isolation. It is recommended that agitation is treated through psychosocial interventions. Dementia Care Mapping™ (DCM™) is an established, widely used observational tool and practice development cycle, for ensuring a systematic approach to providing person-centred care. There is a body of practice-based literature and experience to suggests that DCM™ is potentially effective but limited robust evidence for its effectiveness, and no examination of its cost-effectiveness, as a UK health care intervention. Therefore, a definitive randomised controlled trial (RCT) of DCM™ in the UK is urgently needed.

Methods/design: A pragmatic, multi-centre, cluster-randomised controlled trial of Dementia Care Mapping (DCM™) plus Usual Care (UC) versus UC alone, where UC is the normal care delivered within the care home following a minimum level of dementia awareness training. The trial will take place in residential, nursing and dementia-specialist care homes across West Yorkshire, Oxfordshire and London, with residents with dementia. A random sample of 50 care homes will be selected within which a minimum of 750 residents will be registered. Care homes will be randomised in an allocation ratio of 3:2 to receive either intervention or control. Outcome measures will be obtained at 6 and 16 months following randomisation. The primary outcome is agitation as measured by the Cohen-Mansfield Agitation Inventory, at 16 months post randomisation. Key secondary outcomes are other BSC and quality of life. There will be an integral cost-effectiveness analysis and a process evaluation.

Discussion: The protocol was refined following a pilot of trial procedures. Changes include replacement of a questionnaire, whose wording caused some residents distress, to an adapted version specifically designed for use in care homes, a change to the randomisation stratification factors, adaption in how the staff measures are collected to encourage greater compliance, and additional reminders to intervention homes of when mapping cycles are due, via text message.

Trial Registration: Current Controlled Trials ISRCTN82288852 . Registered on 16 January 2014. Full protocol version and date: v7.1: 18 December 2015.
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http://dx.doi.org/10.1186/s13063-016-1416-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4921015PMC
June 2016

The HAPPY (Healthy and Active Parenting Programmme for early Years) feasibility randomised control trial: acceptability and feasibility of an intervention to reduce infant obesity.

BMC Public Health 2016 Mar 1;16:211. Epub 2016 Mar 1.

Bradford Institute for Health Research, Bradford Teaching Hospital NHS Foundation Trust, Bradford Royal Infirmary, Duckworth Lane, Bradford, BD9 6RJ, UK.

Background: The prevalence of infant obesity is increasing, but there is a lack of evidence-based approaches to prevent obesity at this age. This study tested the acceptability and feasibility of evaluating a theory-based intervention aimed at reducing risk of obesity in infants of overweight/obese women during and after pregnancy: the Healthy and Active Parenting Programme for Early Years (HAPPY).

Methods: A feasibility randomised controlled trial was conducted in Bradford, England. One hundred twenty overweight/obese pregnant women (Body Mass Index [BMI] ≥25 kg/m(2)) were recruited between 10-26 weeks gestation. Consenting women were randomly allocated to HAPPY (6 antenatal, 6 postnatal sessions: N = 59) or usual care (N = 61). Appropriate outcome measures for a full trial were explored, including: infant's length and weight, woman's BMI, physical activity and dietary intake of the women and infants. Health economic data were collected. Measurement occurred before randomisation and when the infant was aged 6 months and 12 months. Feasibility outcomes were: recruitment/attrition rates, and acceptability of: randomisation, measurement, and intervention. Intra-class correlations for infant weight were calculated. Fidelity was assessed through observations and facilitator feedback. Focus groups and semi-structured interviews explored acceptability of methods, implementation, and intervention content.

Results: Recruitment targets were met (~20 women/month) with a recruitment rate of 30 % of eligible women (120/396). There was 30 % attrition at 12 months; 66 % of recruited women failed to attend intervention sessions, but those who attended the first session were likely to continue to attend (mean 9.4/12 sessions, range 1-12). Reaction to intervention content was positive, and fidelity was high. Group clustering was minimal; an adjusted effect size of -0.25 standard deviation scores for infant weight at 12 months (95 % CI: -0.16-0.65) favouring the intervention was observed using intention to treat analyses. No adverse events were reported.

Conclusions: The HAPPY intervention appeared feasible and acceptable to participants who attended and those delivering it, however attendance was low; adaptations to increase initial attendance are recommended. Whilst the study was not powered to detect a definitive effect, our results suggest a potential to reduce risk of infant obesity. The evidence reported provides valuable lessons to inform progression to a definitive trial.

Trial Registration: Current Controlled Trials ISRCTN56735429.
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http://dx.doi.org/10.1186/s12889-016-2861-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4774160PMC
March 2016

Action to Support Practices Implement Research Evidence (ASPIRE): protocol for a cluster-randomised evaluation of adaptable implementation packages targeting 'high impact' clinical practice recommendations in general practice.

Implement Sci 2016 Feb 29;11:25. Epub 2016 Feb 29.

Leeds Institute of Health Sciences, University of Leeds, Leeds, LS2 9JT, UK.

Background: There are recognised gaps between evidence and practice in general practice, a setting which provides particular challenges for implementation. We earlier screened clinical guideline recommendations to derive a set of 'high impact' indicators based upon criteria including potential for significant patient benefit, scope for improved practice and amenability to measurement using routinely collected data. We aim to evaluate the effectiveness and cost-effectiveness of a multifaceted, adaptable intervention package to implement four targeted, high impact recommendations in general practice.

Methods/design: The research programme Action to Support Practice Implement Research Evidence (ASPIRE) includes a pair of pragmatic cluster-randomised trials which use a balanced incomplete block design. Clusters are general practices in West Yorkshire, United Kingdom (UK), recruited using an 'opt-out' recruitment process. The intervention package adapted to each recommendation includes combinations of audit and feedback, educational outreach visits and computerised prompts with embedded behaviour change techniques selected on the basis of identified needs and barriers to change. In trial 1, practices are randomised to adapted interventions targeting either diabetes control or risky prescribing and those in trial 2 to adapted interventions targeting either blood pressure control in patients at risk of cardiovascular events or anticoagulation in atrial fibrillation. The respective primary endpoints comprise achievement of all recommended target levels of haemoglobin A1c (HbA1c), blood pressure and cholesterol in patients with type 2 diabetes, a composite indicator of risky prescribing, achievement of recommended blood pressure targets for specific patient groups and anticoagulation prescribing in patients with atrial fibrillation. We are also randomising practices to a fifth, non-intervention control group to further assess Hawthorne effects. Outcomes will be assessed using routinely collected data extracted 1 year after randomisation. Economic modelling will estimate intervention cost-effectiveness. A process evaluation involving eight non-trial practices will examine intervention delivery, mechanisms of action and unintended consequences.

Discussion: ASPIRE will provide 'real-world' evidence about the effects, cost-effectiveness and delivery of adapted intervention packages targeting high impact recommendations. By implementing our adaptable intervention package across four distinct clinical topics, and using 'opt-out' recruitment, our findings will provide evidence of wider generalisability.

Trial Registration: ISRCTN91989345.
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http://dx.doi.org/10.1186/s13012-016-0387-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4770678PMC
February 2016

Prevention of delirium (POD) for older people in hospital: study protocol for a randomised controlled feasibility trial.

Trials 2015 Aug 8;16:340. Epub 2015 Aug 8.

Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.

Background: Delirium is the most frequent complication among older people following hospitalisation. Delirium may be prevented in about one-third of patients using a multicomponent intervention. However, in the United Kingdom, the National Health Service has no routine delirium prevention care systems. We have developed the Prevention of Delirium Programme, a multicomponent delirium prevention intervention and implementation process. We have successfully carried out a pilot study to test the feasibility and acceptability of implementation of the programme. We are now undertaking preliminary testing of the programme.

Methods/design: The Prevention of Delirium Study is a multicentre, cluster randomised feasibility study designed to explore the potential effectiveness and cost-effectiveness of the Prevention of Delirium Programme. Sixteen elderly care medicine and orthopaedic/trauma wards in eight National Health Service acute hospitals will be randomised to receive the Prevention of Delirium Programme or usual care. Patients will be eligible for the trial if they have been admitted to a participating ward and are aged 65 years or over. The primary objectives of the study are to provide a preliminary estimate of the effectiveness of the Prevention of Delirium Programme as measured by the incidence of new onset delirium, assess the variability of the incidence of new-onset delirium, estimate the intracluster correlation coefficient and likely cluster size, assess barriers to the delivery of the Prevention of Delirium Programme system of care, assess compliance with the Prevention of Delirium Programme system of care, estimate recruitment and follow-up rates, assess the degree of contamination due to between-ward staff movements, and investigate differences in financial costs and benefits between the Prevention of Delirium Programme system of care and standard practice. Secondary objectives are to investigate differences in the number, severity and length of delirium episodes (including persistent delirium); length of stay in hospital; in-hospital mortality; destination at discharge; health-related quality of life and health resource use; physical and social independence; anxiety and depression; and patient experience.

Discussion: This feasibility study will be used to gather data to inform the design of a future definitive randomised controlled trial.

Trial Registration: ISRCTN01187372 . Registered 13 March 2014.
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http://dx.doi.org/10.1186/s13063-015-0847-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4529724PMC
August 2015

Supported self-management for adults with type 2 diabetes and a learning disability (OK-Diabetes): study protocol for a randomised controlled feasibility trial.

Trials 2015 Aug 8;16:342. Epub 2015 Aug 8.

Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.

Background: Individuals with a learning disability (LD) are at higher risk of developing type 2 diabetes, but LD is not straightforward to define or identify, especially at the milder end of the spectrum, which makes case finding difficult. While supported self-management of health problems is now established, current material is largely educational and didactic with little that facilitates behavioural change. The interaction between the person with diabetes and others supporting their care is also largely unknown. For these reasons, there is considerable work needed to prepare for a definitive trial. The aim of this paper is to publish the abridged protocol of this preparatory work.

Methods/design: Phase I is a prospective case-finding study (target n = 120 to 350) to identify and characterise potential participants, while developing a standardised supported self-management intervention. Phase II is a randomised feasibility trial (target n = 80) with blinded outcome assessment. Patients identified in Phase I will be interviewed and consented prior to being randomised to (1) standard treatment, or (2) supported self-management. Both arms will also be provided with an 'easy read' accessible information resource on managing type 2 diabetes. The intervention will be standardised but delivered flexibly depending on patient need, including components for the participant, a supporter, and shared activities. Outcomes will be (i) robust estimates of eligibility, consent and recruitment rates with refined recruitment procedures; (ii) characterisation of the eligible population; (iii) a standardised intervention with associated written materials, (iv) adherence and negative outcomes measures; (v) preliminary estimates of adherence, acceptability, follow-up and missing data rates, along with refined procedures; and (vi) description of standard treatment.

Discussion: Our study will provide important information on the nature of type 2 diabetes in adults with LD living in the community, on the challenges of identifying those with milder LD, and on the possibilities of evaluating a standardised intervention to improve self-management in this population.

Trial Registration: Current Controlled Trials ISRCTN41897033 (registered 21 January 2013).
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http://dx.doi.org/10.1186/s13063-015-0832-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4529698PMC
August 2015

Delivering an Optimised Behavioural Intervention (OBI) to people with low back pain with high psychological risk; results and lessons learnt from a feasibility randomised controlled trial of Contextual Cognitive Behavioural Therapy (CCBT) vs. Physiotherapy.

BMC Musculoskelet Disord 2015 Jun 16;16:147. Epub 2015 Jun 16.

Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, LS2 9JT, Leeds, UK.

Background: Low Back Pain (LBP) remains a common and costly problem. Psychological obstacles to recovery have been identified, but psychological and behavioural interventions have produced only moderate improvements. Reviews of trials have suggested that the interventions lack clear theoretical basis, are often compromised by low dose, lack of fidelity, and delivery by non-experts. In addition, interventions do not directly target known risk mechanisms. We identified a theory driven intervention (Contexual Cognitive Behavioural Therapy, CCBT) that directly targets an evidence-based risk mechanism (avoidance and ensured dose and delivery were optimised. This feasibility study was designed to test the credibility and acceptability of optimised CCBT against physiotherapy for avoidant LBP patients, and to test recruitment, delivery of the intervention and response rates prior to moving to a full definitive trial.

Methods: A randomised controlled feasibility trial with patients randomised to receive CCBT or physiotherapy. CCBT was delivered by trained supervised psychologists on a one to one basis and comprised up to 8 one-hour sessions. Physiotherapy comprised back to fitness group exercises with at least 60 % of content exercise-based. Patients were eligible to take part if they had back pain for more than 3 months, and scored above a threshold indicating fear avoidance, catastrophic beliefs and distress.

Results: 89 patients were recruited. Uptake rates were above those predicted. Scores for credibility and acceptability of the interventions met the set criteria. Response rates at three and six months fell short of the 75 % target. Problems associated with poor response rates were identified and successfully resolved, rates increased to 77 % at 3 months, and 68 % at 6 months. Independent ratings of treatment sessions indicated that CCBT was delivered to fidelity. Numbers were too small for formal analysis. Although average scores for acceptance were higher in the CCBT group than in the group attending physiotherapy (increase of 7.9 versus 5.1) and change in disability and pain from baseline to 6 months were greater in the CCBT group than in the physiotherapy group, these findings should be interpreted with caution.

Conclusions: CCBT is a credible and acceptable intervention for LBP patients who exhibit psychological obstacles to recovery.

Trial Registration: ISRCTN43733490 , registered 15/12/2010.
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http://dx.doi.org/10.1186/s12891-015-0594-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4468803PMC
June 2015
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