Publications by authors named "Stephanie J C Taylor"

74 Publications

Embedding supervised exercise training for men on androgen deprivation therapy into standard prostate cancer care: a feasibility and acceptability study (the STAMINA trial).

Sci Rep 2021 06 14;11(1):12470. Epub 2021 Jun 14.

Allied Health Professionals, Radiotherapy and Oncology, Sheffield Hallam University, Sheffield, UK.

Lifestyle interventions involving exercise training offset the adverse effects of androgen deprivation therapy in men with prostate cancer. Yet provision of integrated exercise pathways in cancer care is sparse. This study assessed the feasibility and acceptability of an embedded supervised exercise training intervention into standard prostate cancer care in a single-arm, multicentre prospective cohort study. Feasibility included recruitment, retention, adherence, fidelity and safety. Acceptability of behaviourally informed healthcare and exercise professional training was assessed qualitatively. Despite the imposition of lockdown for the COVID-19 pandemic, referral rates into and adherence to, the intervention was high. Of the 45 men eligible for participation, 79% (n = 36) received the intervention and 47% (n = 21) completed the intervention before a government mandated national lockdown was enforced in the United Kingdom. Patients completed a mean of 27 min of aerobic exercise per session (SD = 3.48), at 77% heart rate maximum (92% of target dose), and 3 sets of 10 reps of 3 resistance exercises twice weekly for 12 weeks, without serious adverse event. The intervention was delivered by 26 healthcare professionals and 16 exercise trainers with moderate to high fidelity, and the intervention was deemed highly acceptable to patients. The impact of societal changes due to the pandemic on the delivery of this face-to-face intervention remain uncertain but positive impacts of embedding exercise provision into prostate cancer care warrant long-term investigation.
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http://dx.doi.org/10.1038/s41598-021-91876-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8203669PMC
June 2021

The development of a theory and evidence-based intervention to aid implementation of exercise into the prostate cancer care pathway with a focus on healthcare professional behaviour, the STAMINA trial.

BMC Health Serv Res 2021 Mar 25;21(1):273. Epub 2021 Mar 25.

Institute for Population Health Sciences, Queen Mary, University of London, London, UK.

Background: Twice-weekly supervised aerobic and resistance exercise for 12 weeks reduces fatigue and improves quality of life in men on Androgen Deprivation Therapy for prostate cancer. Despite the National Institute for Health and Care Excellence (NICE) proposing this as standard of care, it does not routinely take place in practice. Healthcare professionals are in a prime position to deliver and integrate these recommendations. A change in the behaviour of clinical teams is therefore required. In this paper, we describe the development of a training package for healthcare professionals using theory and evidence to promote delivery of such recommendations as standard care.

Methods: The intervention development process was guided by the Medical Research Council guidance for complex interventions and the Behaviour Change Wheel. Target behaviours were identified from the literature and thirty-five prostate cancer care healthcare professionals (including oncologists, consultant urologists, clinical nurse specialists, physiotherapists, general practitioners and commissioners) were interviewed to understand influences on these behaviours. The Theoretical Domains Framework was used to identify theoretical constructs for change. Behaviour change techniques were selected based on theory and evidence and were translated into intervention content. The intervention was refined with the input of stakeholders including healthcare professionals, patients, and exercise professionals in the form of rehearsal deliveries, focus groups and a workshop.

Results: Seven modifiable healthcare professional target behaviours were identified to support the delivery of the NICE recommendations including identifying eligible patients suitable for exercise, recommending exercise, providing information, exercise referral, providing support and interpret and feedback on progress. Ten domains from the Theoretical Domain's Framework were identified as necessary for change, including improving knowledge and skills, addressing beliefs about consequences, and targeting social influences. These were targeted through twenty-two behaviour change techniques delivered in a half-day, interactive training package. Based on initial feedback from stakeholders, the intervention was refined in preparation for evaluation.

Conclusions: We designed an intervention based on theory, evidence, and stakeholder feedback to promote and support the delivery of NICE recommendations. Future work will aim to test this training package in a multi-centre randomised trial. If proven effective, the development and training package will provide a template for replication in other clinical populations, where exercise has proven efficacy but is insufficiently implemented.
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http://dx.doi.org/10.1186/s12913-021-06266-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7992804PMC
March 2021

Towards implementing exercise into the prostate cancer care pathway: development of a theory and evidence-based intervention to train community-based exercise professionals to support change in patient exercise behaviour (The STAMINA trial).

BMC Health Serv Res 2021 Mar 22;21(1):264. Epub 2021 Mar 22.

Institute for Population Health Sciences, Queen Mary University of London, London, UK.

Background: The National Institute for Health and Care Excellence (NICE) recommend that men on androgen deprivation therapy (ADT) for prostate cancer should receive supervised exercise to manage the side-effects of treatment. However, these recommendations are rarely implemented into practice. Community-based exercise professionals (CBEPs) represent an important target group to deliver the recommendations nationally, yet their standard training does not address the core competencies required to work with clinical populations, highlighting a need for further professional training. This paper describes the development of a training package to support CBEPs to deliver NICE recommendations.

Methods: Development of the intervention was guided by the Medical Research Council guidance for complex interventions and the Behaviour Change Wheel. In step one, target behaviours, together with their barriers and facilitators were identified from a literature review and focus groups with CBEPs (n = 22) and men on androgen deprivation therapy (n = 26). Focus group outputs were mapped onto the Theoretical Domains Framework (TDF) to identify theoretical constructs for change. In step two, behaviour change techniques and their mode of delivery were selected based on psychological theories and evidence to inform intervention content. In step three, the intervention was refined following delivery and subsequent feedback from intervention recipients and stakeholders.

Results: Six modifiable CBEPs target behaviours were identified to support the delivery of the NICE recommendations. Nine domains of the TDF were identified as key determinants of change, including: improving knowledge and skills and changing beliefs about consequences. To target the domains, we included 20 BCTs across 8 training modules and took a blended learning approach to accommodate different learning styles and preferences. Following test delivery to 11 CBEPs and feedback from 28 stakeholders, the training package was refined.

Conclusion: Established intervention development approaches provided a structured and transparent guide to intervention development. A training package for CBEPs was developed and should increase trust amongst patients and health care professionals when implementing exercise into prostate cancer care. Furthermore, if proven effective, the development and approach taken may provide a blueprint for replication in other clinical populations where exercise has proven efficacy but is insufficiently implemented.
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http://dx.doi.org/10.1186/s12913-021-06275-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7982309PMC
March 2021

People's preferences for self-management support.

Health Serv Res 2021 Feb 25. Epub 2021 Feb 25.

Centre for Health Economics, University of York, York, UK.

Objective: To identify and assess the preferences of people with long-term health conditions toward generalizable characteristics of self-management support interventions, with the objective to inform the design of more person-centered support services.

Data Sources: Primary qualitative and quantitative data collected on a representative sample of individuals with at least one of the fifteen most prevalent long-term conditions in the UK.

Study Design: Targeted literature review followed by a series of one-to-one qualitative semistructured interviews and a large-scale discrete choice experiment.

Data Collection: Digital recording of one-to-one qualitative interviews, one-to-one cognitive interviews, and a series of online quantitative surveys, including two best-worst scaling and one discrete choice experiment, with individuals with long-term conditions.

Principal Findings: On average, patients preferred a self-management support intervention that (a) discusses the options available to the patient and make her choose, (b) is individual-based, (c) face to face (d) with doctor or nurse, (e) at the GP practice, (f) sessions shorter than 1 hour, and (g) occurring annually for two-third of the sample and monthly for the rest. We found heterogeneity in preferences via three latent classes, with class sizes of 41% (C1), 30% (C2), and 29% (C3). The individuals' gender [P < 0.05(C1), P < 0.01(C3)], age [P < 0.05(C1), P < 0.05(C2)], type of long-term condition [P < 0.05(C1), P < 0.01(C3)], and presence of comorbidity [P < 0.01(C1), P < 0.01(C3), P < 0.01(C3)] were able to characterize differences between these latent classes and help understand the heterogeneity of preferences toward the above mentioned features of self-management support interventions. These findings were then used to profile individuals into different preference groups, for each of whom the most desirable form of self-management support, one that was more likely to be adopted by the recipient, could be designed.

Conclusions: We identified several factors that could be used to inform a more nuanced self-management support service design and provision that take into account the recipient's characteristics and preferences.
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http://dx.doi.org/10.1111/1475-6773.13635DOI Listing
February 2021

Process evaluation within pragmatic randomised controlled trials: what is it, why is it done, and can we find it?-a systematic review.

Trials 2020 Nov 9;21(1):916. Epub 2020 Nov 9.

Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK.

Background: Process evaluations are increasingly conducted within pragmatic randomised controlled trials (RCTs) of health services interventions and provide vital information to enhance understanding of RCT findings. However, issues pertaining to process evaluation in this specific context have been little discussed. We aimed to describe the frequency, characteristics, labelling, value, practical conduct issues, and accessibility of published process evaluations within pragmatic RCTs in health services research.

Methods: We used a 2-phase systematic search process to (1) identify an index sample of journal articles reporting primary outcome results of pragmatic RCTs published in 2015 and then (2) identify all associated publications. We used an operational definition of process evaluation based on the Medical Research Council's process evaluation framework to identify both process evaluations reported separately and process data reported in the trial results papers. We extracted and analysed quantitative and qualitative data to answer review objectives.

Results: From an index sample of 31 pragmatic RCTs, we identified 17 separate process evaluation studies. These had varied characteristics and only three were labelled 'process evaluation'. Each of the 31 trial results papers also reported process data, with a median of five different process evaluation components per trial. Reported barriers and facilitators related to real-world collection of process data, recruitment of participants to process evaluations, and health services research regulations. We synthesised a wide range of reported benefits of process evaluations to interventions, trials, and wider knowledge. Visibility was often poor, with 13/17 process evaluations not mentioned in the trial results paper and 12/16 process evaluation journal articles not appearing in the trial registry.

Conclusions: In our sample of reviewed pragmatic RCTs, the meaning of the label 'process evaluation' appears uncertain, and the scope and significance of the term warrant further research and clarification. Although there were many ways in which the process evaluations added value, they often had poor visibility. Our findings suggest approaches that could enhance the planning and utility of process evaluations in the context of pragmatic RCTs.

Trial Registration: Not applicable for PROSPERO registration.
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http://dx.doi.org/10.1186/s13063-020-04762-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7650157PMC
November 2020

Tailored, psychological intervention for anxiety and/or depression in people with chronic obstructive pulmonary disease (COPD), TANDEM (Tailored intervention for ANxiety and DEpression Management in COPD): statistical analysis plan for a randomised controlled trial.

Trials 2020 Oct 15;21(1):858. Epub 2020 Oct 15.

Institute of Population Health Sciences, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, UK.

Background: The aim of the TANDEM trial is to evaluate whether a tailored, psychological cognitive behavioural approach intervention, which links into, and optimises the effects of routine pulmonary rehabilitation (PR), leads to a reduction in mild/moderate anxiety and/or depression in people with moderate, severe or very severe chronic obstructive pulmonary disease.

Methods And Design: TANDEM is a multi-centre, two-arm, parallel group, pragmatic, individually randomised controlled, superiority trial including an internal pilot. Participants are randomised to receive either the intervention (a tailored psychological intervention plus usual care including referral to PR) or the control (usual care including referral to PR). The designed randomisation ratio is 1.25:1 in favour of the intervention. The multiple-primary outcomes are participant depression and anxiety at 6 months, measured using the Hospital Anxiety and Depression Scale (HADS) depression and anxiety subscales.

Results: This article describes the statistical analysis plan (SAP) for the TANDEM trial. In particular, we describe the general analysis principles, how we will handle missing data, the primary and secondary outcomes and how these will be analysed, sensitivity analyses for the multiple-primary outcomes, and any other analyses and data summaries. The SAP was developed and published prior to completion of follow-up of the last participant.

Trial Registration: ISRCTN registry ISRCTN59537391. Registered on 20 March 2017.
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http://dx.doi.org/10.1186/s13063-020-04786-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7559776PMC
October 2020

Adherence and the Moral Construction of the Self: A Narrative Analysis of Anticoagulant Medication.

Qual Health Res 2020 12 28;30(14):2316-2330. Epub 2020 Aug 28.

Queen Mary University of London, London, United Kingdom.

In this article, we examine illness narratives to illuminate the discursive work that patients undertake to construct themselves as "good" and adherent. Biographical narrative interviews were undertaken with 17 patients receiving anticoagulation for stroke prevention in atrial fibrillation, from five English hospitals (May 2016-June 2017). Through pluralistic narrative analysis, we highlight the discursive tensions narrators face when sharing accounts of their medicine-taking. They undertake challenging linguistic and performative work to reconcile apparently paradoxical positions. We show how the adherent patient is co-constructed through dialogue at the intersection of discourses including authority of doctors, personal responsibility for health, scarcity of resources, and deservingness. We conclude that the notion of medication adherence places a hidden moral and discursive burden of treatment on patients which they must negotiate when invited into conversations about their medications. This discursive work reveals, constitutes, and upholds medicine-taking as a profoundly moral practice.
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http://dx.doi.org/10.1177/1049732320951772DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7649927PMC
December 2020

A Lay Health Worker Intervention to Increase Uptake and Completion of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease: Assessing Fidelity of Intervention Delivery.

COPD 2020 10 17;17(5):557-561. Epub 2020 Aug 17.

Centre for Behaviour Change, Department of Clinical, Educational and Health Psychology, University College London, London, UK.

The benefits of pulmonary rehabilitation (PR) for chronic obstructive pulmonary disease (COPD) are restricted by poor uptake and completion. Lay health workers (LHWs) have been effective in improving access to treatment and services for other health conditions. We have successfully shown the feasibility of this approach in a PR setting and its acceptability to the LHWs and COPD patients. We present here the feasibility of assessment, and the fidelity of delivery of LHW support achieved for COPD patients referred for PR. LHWs, volunteer COPD patients experienced in PR, received training in the intervention including communication skills, confidentiality and behaviour change techniques (BCTs). Interactions between LHWs and patients were recorded, transcribed and coded for delivery style and BCTs. Inter-rater agreement on the coding of delivery style and BCTs was high at >84%. LHWs built rapport and communicated attentively in over 80% of interactions. LHWs most consistently delivered BCTs concerning information provision about the consequences of PR often making those consequences salient by referring to their own positive experience of PR. Social support BCTs were also used by the majority of LHWs. The use of BCTs varied between LHWs. The assessment of intervention delivery fidelity by LHWs was feasible. LHW training in the setting of PR should add emphasis to the acquisition of BCT skills relating to goal setting and action planning.
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http://dx.doi.org/10.1080/15412555.2020.1797658DOI Listing
October 2020

Supervised pulmonary hypertension exercise rehabilitation (SPHERe): study protocol for a multi-centre randomised controlled trial.

BMC Pulm Med 2020 May 19;20(1):143. Epub 2020 May 19.

Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.

Background: Supervised cardio-pulmonary rehabilitation may be safe and beneficial for people with pulmonary hypertension (PH) in groups 1 (pulmonary arterial hypertension) and 4 (chronic thromboembolic disease), particularly as a hospital in-patient. It has not been tested in the most common PH groups; 2 (left heart disease), 3 (lung disease), or 5 (other disorders). Further it has not been evaluated in the UK National Health Service (NHS) out-patient setting, or with long-term follow-up. The aim of this randomised controlled trial (RCT) is to test the clinical and cost-effectiveness of a supervised exercise rehabilitation intervention with psychosocial support compared to best practice usual care for people with PH in the community/outpatient setting.

Methods: This multi-centre, pragmatic, two-arm RCT with embedded process evaluation aims to recruit 352 clinically stable adults with PH (groups 1-5) and WHO functional class II-IV. Participants will be randomised to either the Supervised Pulmonary Hypertension Exercise Rehabilitation (SPHERe) intervention or control. The SPHERe intervention consists of 1) individual assessment and familiarisation sessions; 2) 8-week, twice-weekly, supervised out-patient exercise training; 3) psychosocial/motivational support and education; 4) guided home exercise plan. The control intervention consists of best practice usual care with a single one-to-one practitioner appointment, and general advice on physical activity. Outcomes will be measured at baseline, 4 months (post-intervention) and 12 months by researchers blinded to treatment allocation. The primary outcome is the incremental shuttle walk test at 4 months. Secondary outcomes include health-related quality of life (HRQoL), time to clinical worsening and health and social care use. A purposive sample of participants (n = 20 intervention and n = 20 control) and practitioners (n = 20) will be interviewed to explore experiences of the trial, outcomes and interventions.

Discussion: The SPHERe study is the first multi-centre clinical RCT to assess the clinical and cost effectiveness of a supervised exercise rehabilitation intervention compared to usual care, delivered in the UK NHS, for people in all PH groups. Results will inform clinicians and commissioners as to whether or not supervised exercise rehabilitation is effective and should be routinely provided for people with PH.

Trial Registration: ISRCTN no. 10608766, prospectively registered on 18th March 2019.
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http://dx.doi.org/10.1186/s12890-020-01182-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7236437PMC
May 2020

Tailored, psychological intervention for anxiety or depression in people with chronic obstructive pulmonary disease (COPD), TANDEM (Tailored intervention for ANxiety and DEpression Management in COPD): protocol for a randomised controlled trial.

Trials 2020 Jan 6;21(1):18. Epub 2020 Jan 6.

Institute for Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK.

Background: People with chronic obstructive pulmonary disease (COPD) are at increased risk of depression and anxiety, which greatly reduces their quality of life and is associated with worse outcomes; but these psychological co-morbidities are under-recognised and undertreated in COPD patients. Pulmonary rehabilitation (PR) improves mood for up to 6 months but health practitioners under-refer, and patients commonly fail to attend/complete PR. Research suggests that complex non-pharmacological interventions, including both psychological and exercise components, may reduce anxiety and depression in COPD. We have developed a tailored, cognitive behavioural approach (CBA) intervention for patients with COPD and co-morbid anxiety and/or depression ('TANDEM'), which precedes and optimises the benefits of currently offered PR. We hypothesise that such a psychological intervention, delivered by supervised, trained respiratory healthcare professionals, will improve mood in patients with mild to moderate anxiety and/or depression and encourage uptake and completion of PR.

Methods: We will conduct a multi-centre, pragmatic, randomised controlled trial of the TANDEM intervention compared to usual care across the Midlands, London, the South East and Bristol, UK. We will train healthcare professionals familiar with COPD to deliver the manualised, tailored, face-to-face, one-to-one intervention weekly for 6-8 weeks. We will recruit 430 participants from primary, community and secondary care with confirmed COPD and moderate to very severe airflow limitation, who are eligible for assessment for PR, and who screen positive for symptoms of mild/moderate depression and/or anxiety using the Hospital Anxiety and Depression scale (HADS). Participants will be randomised 1.25:1 (intervention: usual care). The co-primary outcomes are the HADS anxiety and depression subscale scores at 6 months; participants will be followed up to 12 months. Secondary outcomes include uptake and completion of PR and healthcare resource use. There will be a parallel process evaluation and a health economic evaluation.

Discussion: The TANDEM intervention has the potential to optimise the unrealised synergy between a psychological intervention and PR. The CBA sessions will precede PR and target individuals' cognitions, behaviours and symptoms associated with anxiety and depression to decrease psychological morbidity and increase effective self-management amongst patients with COPD.

Trial Registration: ISRCTN, ID: ISRCTN59537391. Registered on 20 March 2017. Protocol version 6.0, 22 April 2018.
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http://dx.doi.org/10.1186/s13063-019-3800-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6945421PMC
January 2020

Improving the relevance of randomised trials to primary care: a qualitative study investigating views towards pragmatic trials and the PRECIS-2 tool.

Trials 2019 Dec 11;20(1):711. Epub 2019 Dec 11.

Queen Mary, University of London, London, UK.

Background: Pragmatic trials have been suggested as a way to improve the relevance of clinical trial results to practice. PRECIS-2 (Pragmatic Explanatory Continuum Indicator Summary-2) is a trial design tool which considers how pragmatic a trial is across a number of domains. It is not known whether a pragmatic approach to all PRECIS-2 domains leads to results being more relevant to primary care. The aim of this study was to investigate the views of people with influence on primary care practice towards the design of randomised trials, pragmatic approaches to trial design, and the PRECIS-2 domains.

Methods: We carried out semi-structured interviews with people who influence practice in primary care in the UK. A thematic analysis was undertaken using the framework approach.

Results: We conducted individual or small group interviews involving an elite sample of 17 individuals. We found that an exclusively pragmatic approach to randomised trials may not always make the results of trials more applicable to primary care. For example, it may be better to have less flexibility in the way interventions are delivered in randomised trials than in practice. In addition, an appropriate balance needs to be struck when thinking about levels of resourcing and the intensity of steps needed to improve adherence in a trial. Across other aspects of a trial's design, for example the population and trial setting, a pragmatic approach was viewed as more appropriate.

Conclusions: To maximize the relevance of research directed at primary care, trials should be conducted with the same populations and settings that are found in primary care. Across other aspects of trials it is not always necessary to match the conditions found in practice.
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http://dx.doi.org/10.1186/s13063-019-3812-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6907200PMC
December 2019

Models and tools for those living with and beyond cancer.

Crit Rev Oncol Hematol 2019 12 17;144:102819. Epub 2019 Oct 17.

Department of Primary Care and Public Health, Barts and The London School of Medicine & Dentistry, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London E1 2AB, United Kingdom.

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http://dx.doi.org/10.1016/j.critrevonc.2019.102819DOI Listing
December 2019

Emergency packs for asthma: the simplicity is appealing but overlooks the complexity.

Lancet Respir Med 2019 07;7(7):e21

Centre for Primary Care and Public Health, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.

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http://dx.doi.org/10.1016/S2213-2600(19)30186-9DOI Listing
July 2019

Evaluating the effectiveness and cost-effectiveness of the Smoking Treatment Optimisation in Pharmacies (STOP) intervention: protocol for a cluster randomised controlled trial.

Trials 2019 Jun 10;20(1):337. Epub 2019 Jun 10.

Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.

Background: NHS community pharmacies provide effective smoking cessation services; however, there is scope for increasing throughput and improving quit rates. This trial examines whether the Smoking Treatment Optimisation in Pharmacies (STOP) intervention can improve smoker engagement to increase service throughput, retention and quitting.

Methods: This study is a pragmatic, cluster randomised controlled trial in 60 pharmacies in England and Wales. All workers in intervention pharmacies are offered STOP training while control pharmacies provide usual care. The STOP intervention, based on behavioural and organisational theories, comprises educational sessions for staff and environmental prompts in the pharmacy. Intervention fidelity is assessed by actors visiting pharmacies posing as smokers. The primary outcome is throughput, defined as the number of smokers who join the programme, set a firm quit date and undergo at least one stop smoking treatment session, and is measured using routinely collected data. Secondary outcomes include retention and quit rates at 4 weeks and continuous abstinence at 6 months verified by salivary cotinine. Cost-effectiveness is estimated using quality-adjusted life years and the probability that the intervention is effective at different levels of willingness to pay is calculated.

Discussion: The trial will generate evidence to inform the public health smoking cessation strategy in England and Wales, and may help to shape service commissioning decisions. The STOP intervention model may help inform the undertaking of a range of health behaviour change tasks in community pharmacies.

Trial Registration: ClinicalTrials.gov, ISRCTN16351033. Retrospectively registered on 21 March 2017.
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http://dx.doi.org/10.1186/s13063-019-3368-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6558670PMC
June 2019

The CHESS trial: protocol for the process evaluation of a randomised trial of an education and self-management intervention for people with chronic headache.

Trials 2019 Jun 4;20(1):323. Epub 2019 Jun 4.

Warwick Clinical Trials Unit, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.

Background: Process evaluation is increasingly common alongside complex randomised controlled trials (RCTs). This evaluation helps in understanding the mechanisms of impact and how the study processes were executed, and it includes any contextual factors which may have implications for the trial results and any future implementation. This process evaluation is for the Chronic Headache Education and Self-management Study (CHESS) RCT, which is evaluating an education and self-management group behavioural intervention for people with chronic headache. Chronic headache is defined as headaches which are present for 15 or more days per month. The most common types are chronic migraine and chronic tension type and medication overuse headaches.

Methods: We will use a mixed methods approach. Quantitative data will be taken from routine trial data which will help us to assess the reach of the study; i.e. did we reach those whom we expected and from where? Intervention attendance (dose received) and attrition and qualitative data will augment our understanding about reasons why people may not wish to take part in or failed to attend sessions. Interviews with intervention facilitators and trial participants will gain different perspectives on taking part in the trial. Fidelity will be assessed through listening to audio recordings for adherence to course content and competence of the facilitation of a sample of sessions.

Discussion: Our process evaluation will allow us to gain insight into how the trial was delivered, the obstacles and enablers encountered and the possible reasons why the interventions may or may not be effective.

Trial Registration: ISRCTN79708100 . Registered on 16 December 2015.
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http://dx.doi.org/10.1186/s13063-019-3372-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6549347PMC
June 2019

Development of an education and self-management intervention for chronic headache - CHESS trial (Chronic Headache Education and Self-management Study).

J Headache Pain 2019 Mar 18;20(1):28. Epub 2019 Mar 18.

Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.

Background: Self-management interventions are well recognised and widely used in chronic conditions. Their application to chronic headaches has been limited and generally of low quality. We describe here our process for developing an evidence based, and theory driven, education and self-management intervention for those living with chronic headache.

Methods: Our intervention was designed using several core information sources; the results of three systematic reviews, qualitative material from those living with chronic headaches, our knowledge from existing self-management interventions; and finally collaborative input from a multidisciplinary team of clinicians, academics, patients, and charity partners. We manualised the intervention and associated training as a package for use in a feasibility study. We made adaptations for its use in a randomised controlled trial.

Results: We piloted the intervention in four groups with a total of 18 participants. Qualitative feedback from 12 participants and five facilitators allowed the intervention to be refined for the main randomised controlled trial. Some of the key changes included shortening of the overall intervention, changes to the originally planned facilitators and spreading the facilitator training over three days rather than two. We are now testing the final revised intervention in a randomised controlled trial of its clinical and cost effectiveness. The group component of the intervention is delivered over two days with the first day focused on living, understanding and dealing with chronic headaches and the second day exploring how to adapt and take control of one's life with chronic headaches.

Conclusion: Our pilot work indicates that our intervention is feasible to deliver, and with the relevant changes would be acceptable for use with this population. Our randomised control trial is ongoing. We anticipate publishing final results in 2021.

Trial Registration: ISRCTN79708100. Registered 16th December 2015, http://www.isrctn.com/ISRCTN79708100.
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http://dx.doi.org/10.1186/s10194-019-0980-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6734363PMC
March 2019

Improving uptake and completion of pulmonary rehabilitation in COPD with lay health workers: feasibility of a clinical trial.

Int J Chron Obstruct Pulmon Dis 2019;14:631-643. Epub 2019 Mar 12.

Department of Clinical, Educational and Health Psychology, University College London, London, UK.

Purpose: This study was designed to evaluate the feasibility of a cluster randomized controlled trial to test the efficacy of lay health workers (LHWs) in improving the uptake and completion of pulmonary rehabilitation (PR) in the treatment of COPD.

Materials And Methods: LHWs, trained in confidentiality, role boundaries, and behavior change techniques, supported patients newly referred for PR. Interactions between LHWs and participants were recorded with smartphones. Outcomes were recruitment and retention rates of LHWs, questionnaire and interview-evaluated acceptability and analysis of intervention fidelity.

Results: Forty (36%) of 110 PR-experienced COPD patients applied to become LHWs. Twenty (18%) were selected for training. Twelve (11%) supported patients. Sixty-six COPD patients referred for PR received the intervention (5.5 participants per LHW). Ten LHWs were retained to the end of the study. Seventy-three percent of supported patients were satisfied or very satisfied with the intervention. LHWs delivered the intervention with appropriate style and variable fidelity. LHWs would welcome more intensive training. Based on this proof of concept, a cluster randomized controlled trial of an LHW intervention to improve uptake and completion of PR is feasible.

Conclusion: PR-experienced COPD patients can be recruited, trained, and retained as LHWs to support participation in PR, and can deliver the intervention. Participant COPD patients found the intervention acceptable. A cluster randomized controlled clinical trial is feasible.
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http://dx.doi.org/10.2147/COPD.S188731DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6419591PMC
July 2019

Chronic Headache Education and Self-management Study (CHESS) - a mixed method feasibility study to inform the design of a randomised controlled trial.

BMC Med Res Methodol 2019 02 11;19(1):30. Epub 2019 Feb 11.

Headache Group, UCL Institute of Neurology and The National Hospital for Neurology and Neurosurgery, Queen Square, London, WC1N 3BG, UK.

Background: Self-management support programmes are effective in a range of chronic conditions however there is limited evidence for their use in the treatment of chronic headaches. The aim of this study was to test the feasibility of four key aspects of a planned, future evaluative trial of a new education and self-management intervention for people with chronic headache: 1) recruiting people with chronic headache from primary care; 2) a telephone interview for the classification of chronic headaches; 3) the education and self-management intervention itself; and 4) the most appropriate patient reported outcomes (PROMS).

Methods: Participants were identified and recruited from general practices in the West Midlands of the UK. We developed a nurse-led chronic headache classification interview and assessed agreement with an interview with headache specialists. We developed and tested a group based education and self-management intervention to assess training and delivery receipt using observation, facilitator, and participant feedback. We explored the acceptability and relevance of PROMs using postal questionnaires, interviews and a smartphone app.

Results: Fourteen practices took part in the study and participant recruitment equated to 1.0/1000 registered patients. Challenges to recruitment were identified. We did 107 paired headache classification interviews. The level of agreement between nurse and doctor interviews was very good. We piloted the intervention in four groups with 18 participants. Qualitative feedback from participants and facilitators helped refine the intervention including shortening the overall intervention and increasing the facilitator training time. Participants completed 131 baseline questionnaires, measurement data quality, reliability and validity for headache-specific and generic measures was acceptable.

Conclusion: This study indicated that recruiting people with chronic headache from primary care is feasible but challenging, our headache classification interview is fit for purpose, our study intervention is viable, and that our choice of outcome measures is acceptable to participants in a future randomised controlled trial (RCT).

Trial Registration: ISRCTN, ISRCTN79708100. Registered 16th December 2015, http://www.isrctn.com/ISRCTN79708100.
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http://dx.doi.org/10.1186/s12874-019-0672-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6371558PMC
February 2019

Supported self-management for people with type 2 diabetes: a meta-review of quantitative systematic reviews.

BMJ Open 2018 12 14;8(12):e024262. Epub 2018 Dec 14.

Usher Institute of Population Health Sciences and Informatics, The University of Edinburgh, Edinburgh, UK.

Objectives: Self-management support aims to give people with chronic disease confidence to actively manage their disease, in partnership with their healthcare provider. A meta-review can inform policy-makers and healthcare managers about the effectiveness of self-management support strategies for people with type 2 diabetes, and which interventions work best and for whom.

Design: A meta-review of systematic reviews of randomised controlled trials (RCTs) was performed adapting Cochrane methodology.

Setting And Participants: Eight databases were searched for systematic reviews of RCTs from January 1993 to October 2016, with a pre-publication update in April 2017. Forward citation was performed on included reviews in Institute for Scientific Information (ISI) Proceedings. We extracted data and assessed quality with the Revised-Assessment of Multiple Systematic Reviews (R-AMSTAR).

Primary And Secondary Outcome Measures: Glycaemic control as measured by glycated haemoglobin (HbA1c) was the primary outcome. Body mass Index, lipid profiles, blood pressure and quality of life scoring were secondary outcomes. Meta-analyses reporting HbA1c were summarised in meta-forest plots; other outcomes were synthesised narratively.

Results: 41 systematic reviews incorporating data from 459 unique RCTs in diverse socio-economic and ethnic communities across 33 countries were included. R-AMSTAR quality score ranged from 20 to 42 (maximum 44). Apart from one outlier, the majority of reviews found an HbA1c improvement between 0.2% and 0.6% (2.2-6.5 mmol/mol) at 6 months post-intervention, but attenuated at 12 and 24 months. Impact on secondary outcomes was inconsistent and generally non-significant. Diverse self-management support strategies were employed; no single approach appeared optimally effective (or ineffective). Effective programmes tended to be multi-component and provide adequate contact time (>10 hours). Technology-facilitated self-management support showed a similar impact as traditional approaches (HbA1c MD -0.21% to -0.6%).

Conclusions: Self-management interventions using a range of approaches improve short-term glycaemic control in people with type 2 diabetes including culturally diverse populations. These findings can inform researchers, policy-makers and healthcare professionals re-evaluating the provision of self-management support in routine care. Further research should consider implementation and sustainability.
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http://dx.doi.org/10.1136/bmjopen-2018-024262DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6303627PMC
December 2018

IMPART systematic review of education for healthcare professionals implementing supported self-management for asthma.

NPJ Prim Care Respir Med 2018 11 6;28(1):42. Epub 2018 Nov 6.

Asthma UK Centre for Applied Research, Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.

Despite a robust evidence base for its effectiveness, implementation of supported self-management for asthma is suboptimal. Professional education is an implementation strategy with proven effectiveness, though the specific features linked with effectiveness are often unclear. We performed a systematic review of randomised controlled trials and controlled clinical trials (published from 1990 and updated to May 2017 using forward citation searching) to determine the effectiveness of professional education on asthma self-management support and identify features of effective initiatives. Primary outcomes reflected professional behaviour change (provision of asthma action plans) and patient outcomes (asthma control; unscheduled care). Data were coded using the Effective Practice and Organisation of Care Taxonomy, the Theoretical Domains Framework (TDF), and Bloom's Taxonomy and synthesised narratively. Of 15,637 articles identified, 18 (reporting 15 studies including 21 educational initiatives) met inclusion criteria. Risk of bias was high for five studies, and unclear for 10. Three of 6 initiatives improved action plan provision; 1/2 improved asthma control; and 2/7 reduced unscheduled care. Compared to ineffective initiatives, effective initiatives were more often coded as being guideline-based; involving local opinion leaders; including inter-professional education; and addressing the TDF domains 'social influences'; 'environmental context and resources'; 'behavioural regulation'; 'beliefs about consequences'; and 'social/professional role and identity'. Findings should be interpreted cautiously as many strategies were specified infrequently. However, identified features warrant further investigation as part of implementation strategies aiming to improve the provision of supported self-management for asthma.
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http://dx.doi.org/10.1038/s41533-018-0108-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6219611PMC
November 2018

The acceptability of an online intervention using positive psychology for depression: A qualitative study.

Internet Interv 2018 Sep 8;13:60-66. Epub 2018 Jul 8.

Queen Mary University of London, Unit for Social and Community Psychiatry (WHO Collaborating Centre for Mental Health Services Development), Glen Road, London, Newham E13 8SP, UK.

Background: Positive psychology interventions may usefully treat depression and can be delivered online to reduce the treatment gap. However, little is known about how acceptable patients find this approach. To address this, the present study interviewed recent users of a positive psychology self-help website.

Methods: In-depth semi-structured interviews explored the experiences of twenty-three participants from a larger feasibility study. A stratified purposive sampling strategy selected participants with varying intervention experience according to their intervention logins, as well as varying age, gender and depressive symptoms. Framework analysis was used to explore patterns and linkages within and between participants' accounts.

Results: Acceptability varied between participants. Those who found it more acceptable felt it was relevant to their depression and reported feeling empowered by a self-help approach. Conversely, participants for whom it was less acceptable perceived the positive focus irrelevant to their depression and found the emphasis on self-action unsupportive.

Conclusions: The acceptability of an online positive psychology intervention may be facilitated by a patients' preference for a psychological focus on the positive. However, patients may also have distinct preferences for online self-help. Future research should investigate the importance of the therapeutic orientation of online self-help interventions and whether patients' preferences for these can be reliably identified. This could help to target online self-help in clinical practice.
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http://dx.doi.org/10.1016/j.invent.2018.07.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6112095PMC
September 2018

What might affect acceptability of online positive psychology interventions for depression: a qualitative study on patient expectations'.

BMC Psychiatry 2018 07 27;18(1):240. Epub 2018 Jul 27.

Queen Mary University of London, Unit for Social and Community Psychiatry (WHO Collaborating Centre for Mental Health Services Development), Glen Road, London, Newham, E13 8SP, UK.

Background: Positive psychology interventions are brief self-adminstered exercises designed to promote positive emotions, behaviours, or thoughts. They are potentially effective for reducing depression and are considered suitable for online dissemination to people with depression and related conditions, as they are assumed to be more acceptable than traditional symptom-focused approaches. However, there is little investigation into perceived acceptability and potential factors that might affect it. This might limit the development and evaluation of effective interventions.

Methods: Semi-structured interviews with patients with depression and/or anxiety (n = 18) and professionals, including GPs and psychologists (n = 5) were conducted on their perceptions of a proposed online intervention using positive psychology. Thematic analysis, according to Braun and Clarke, was used to identify meaningful patterns in the data.

Results: Four key themes were identified. The fit between the positive psychological approach and the patient's context, including their personality, symptoms and other treatments, was important in determining acceptability. Social aspects of interventions were thought to facilitate acceptability, as long as these were balanced. Support was identified as important in facilitating intervention suitability, although it was not without limitations. Finally, participants identified how design features can enhance acceptability.

Conclusions: The findings suggest that positive psychology interventions might not be acceptable to all and that specific exercises might be more or less appropriate to deliver online. Design aspects can help to facilitate acceptability, beyond the psychological content. These findings may inform the design of future online psychology interventions for people with depression and anxiety, which can then be evaluated in future research.
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http://dx.doi.org/10.1186/s12888-018-1812-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6062878PMC
July 2018

Supporting self-management for people with hypertension: a meta-review of quantitative and qualitative systematic reviews.

J Hypertens 2019 02;37(2):264-279

Usher Institute of Population Health Sciences and Informatics, The University of Edinburgh, Edinburgh.

Objectives: Globally, healthcare policy promotes supported self-management as a strategy for people with long-term conditions. This meta-review aimed to explore how people with hypertension make sense of their condition, to assess the effectiveness of supported self-management in hypertension, and to identify effective components of support.

Methods: From a search of eight databases (January 1993-October 2012; update June 2017) we included systematic syntheses of qualitative studies of patients' experiences, and systematic reviews of randomized controlled trials evaluating the impact of supported self-management on blood pressure and medication adherence. We used meta-ethnography, meta-Forest plots and narrative analysis to synthesise the data.

Results: Six qualitative and 29 quantitative reviews provided data from 98 and 446 unique studies, respectively. Self-management support consistently reduced SBP (by between 2 and 6 mmHg), and DBP (by between 1 and 5 mmHg). Information about hypertension and treatment, home BP monitoring (HBPM) and feedback (including telehealth) were widely used in effective interventions. Patients' perceptions of a disease with multiple symptoms contrasted with the professional view of an asymptomatic condition. HBPM, in the context of a supportive patient-professional relationship, changed perceptions of the significance of symptoms and fostered confidence in ability to self-manage hypertension.

Conclusion: Our systematic qualitative and quantitative meta-reviews tell complementary stories. Supported self-management can improve blood pressure control. Interventions are complex and encompass a broad range of support strategies. HBPM (with or without telehealth) within the context of a supportive patient-professional partnership can bridge the gap between medical and lay perspectives of hypertension and enable effective self-management.
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http://dx.doi.org/10.1097/HJH.0000000000001867DOI Listing
February 2019

Opioid prescribing for chronic musculoskeletal pain in UK primary care: results from a cohort analysis of the COPERS trial.

BMJ Open 2018 06 6;8(6):e019491. Epub 2018 Jun 6.

Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.

Objective: To establish the level of opioid prescribing for patients with chronic musculoskeletal pain in a sample of patients from primary care and to estimate prescription costs.

Design: Secondary data analyses from a two-arm pragmatic randomised controlled trial (COPERS) testing the effectiveness of group self-management course and usual care against relaxation and usual care for patients with chronic musculoskeletal pain (ISRCTN 24426731).

Setting: 25 general practices and two community musculoskeletal services in the UK (London and Midlands).

Participants: 703 chronic pain participants; 81% white, 67% female, enrolled in the COPERS trial.

Main Outcome Measures: Anonymised prescribing data over 12 months extracted from GP electronic records.

Results: Of the 703 trial participants with chronic musculoskeletal pain, 413 (59%) patients were prescribed opioids. Among those prescribed an opioid, the number of opioid prescriptions varied from 1 to 52 per year. A total of 3319 opioid prescriptions were issued over the study period, of which 53% (1768/3319) were for strong opioids (tramadol, buprenorphine, morphine, oxycodone, fentanyl and tapentadol). The mean number of opioid prescriptions per patient prescribed any opioid was 8.0 (SD=7.9). A third of patients on opioids were prescribed more than one type of opioid; the most frequent combinations were: codeine plus tramadol and codeine plus morphine. The cost of opioid prescriptions per patient per year varied from £3 to £4844. The average annual prescription cost was £24 (SD=29) for patients prescribed weak opioids and £174 (SD=421) for patients prescribed strong opioids. Approximately 40% of patients received >3 prescriptions of strong opioids per year, with an annual cost of £236 per person.

Conclusions: Long-term prescribing of opioids for chronic musculoskeletal pain is common in primary care. For over a quarter of patients receiving strong opioids, these drugs may have been overprescribed according to national guidelines.

Trial Registration Number: ISRCTN24426731; Post-results.
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http://dx.doi.org/10.1136/bmjopen-2017-019491DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6009475PMC
June 2018

The effectiveness of a group self-management education course for adults with poorly controlled epilepsy, SMILE (UK): A randomized controlled trial.

Epilepsia 2018 05 16;59(5):1048-1061. Epub 2018 Apr 16.

Department of Psychology, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.

Objective: Epilepsy is one of the most common neurological conditions affecting about 1% of adults. Up to 40% of people with epilepsy (PWE) report recurring seizures while on medication. And optimal functioning requires good self-management. Our objective was to evaluate a group self-management education courses for people with epilepsy and drug-resistant seizures by means of a multicenter, pragmatic, parallel group, randomized controlled trial.

Methods: We recruited adults with epilepsy, having ≥2 seizures in the prior 12 months, from specialist clinics. Consenting participants were randomized 1:1 to a group course or treatment as usual. The primary outcome measure was quality of life 12 months after randomization using Quality of Life 31-P (QOLIE-31-P). Secondary outcome measures were seizure frequency and recency, psychological distress, impact and stigma of epilepsy, self-mastery, medication adherence, and adverse effects. Analysis of outcomes followed the intention-to-treat principle using mixed-effects regression models.

Results: We enrolled 404 participants (intervention: n = 205, control: n = 199) with 331 (82%) completing 12-month follow-up (intervention: n = 163, control: n = 168). Mean age was 41.7 years, ranging from 16 to 85, 54% were female and 75% were white. From the intervention arm, 73.7% attended all or some of the course. At 12-month follow-up, there were no statistically significant differences between trial arms in QOLIE-31-P (intervention mean: 67.4, standard deviation [SD]: 13.5; control mean: 69.5, SD 14.8) or in secondary outcome measures.

Significance: This is the first pragmatic trial of group education for people with poorly controlled epilepsy. Recruitment, course attendance, and follow-up rates were higher than expected. The results show that the primary outcome and quality of life did not differ between the trial arms after 12 months. We found a high prevalence of felt-stigma and psychological distress in this group of people with drug-resistant seizures. To address this, social and psychological interventions require evaluation, and may be necessary before or alongside self-management-education courses.
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http://dx.doi.org/10.1111/epi.14073DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5969309PMC
May 2018

Interventions to enhance the adoption of asthma self-management behaviour in the South Asian and African American population: a systematic review.

NPJ Prim Care Respir Med 2018 02 15;28(1). Epub 2018 Feb 15.

Asthma UK Centre for Applied Research, Usher Institute of Population Health Sciences and Informatics, The University of Edinburgh, Edinburgh, UK.

South Asian and other minority communities suffer poorer asthma outcomes, have a higher rate of unscheduled care and benefit less from most existing self-management interventions when compared to the majority population. Possible reasons for these differences include failure to implement asthma self-management strategies, or that strategies implemented were inappropriate for their needs; alternatively, they may relate to the minority and/or lower socioeconomic status of these populations. We aimed to synthesise evidence from randomised controlled trials for asthma self-management in South Asian and Black populations from different sociocultural contexts, and identify barriers and facilitators to implementing self-management. We systematically searched eight electronic databases, and research registers, and manually searched relevant journals and reference lists of reviews. Seventeen trials met the inclusion criteria and were analysed narratively. We found two culturally targeted interventions compared to fifteen culturally modified interventions. Interventions used diverse self-management strategies; education formed a central component. Interventions in South Asian and African-American minority communities were less effective than interventions delivered in indigenous populations in South Asia, though the latter trials were at higher risk of bias. Education, with continuous professional support, was common to most interventions. Facilitators to asthma self-management included: ensuring culturally/linguistically appropriate education, adapting to learning styles, addressing daily stressors/social support and generic self-management strategies. In conclusion, when developing and evaluating self-management interventions aimed at different cultures, the influence of sociocultural contexts (including whether patients are from a minority or indigenous population) can be important for the conceptualisation of culture and customisation of self-management strategies.
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http://dx.doi.org/10.1038/s41533-017-0070-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5814446PMC
February 2018

Smartphone App Using Mindfulness Meditation for Women With Chronic Pelvic Pain (MEMPHIS): Protocol for a Randomized Feasibility Trial.

JMIR Res Protoc 2018 Jan 15;7(1):e8. Epub 2018 Jan 15.

Women's Health Research Unit, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.

Background: Female chronic pelvic pain (CPP) is defined as intermittent or constant pelvic or lower abdominal pain occurring in a woman for at least 6 months. Up to a quarter of women are estimated to be affected by CPP worldwide and it is responsible for one fifth of specialist gynecological referrals in the United Kingdom. Psychological interventions are commonly utilized. As waiting times and funding capacity impede access to face-to-face consultations, supported self-management (SSM) has emerged as a viable alternative. Mindfulness meditation is a potentially valuable SSM tool, and in the era of mobile technology, this can be delivered to the individual user via a smartphone app.

Objective: To assess the feasibility of conducting a trial of a mindfulness meditation intervention delivered by a mobile phone app for patients with CPP. The main feasibility objectives were to assess patient recruitment and app adherence, to obtain information to be used in the sample size estimate of a future trial, and to receive feedback on usability of the app.

Methods: Mindfulness Meditation for Women With Chronic Pelvic Pain (MEMPHIS) is a three-arm feasibility trial, that took place in two hospitals in the United Kingdom. Eligible participants were randomized in a 1:1:1 ratio to one of three treatment arms: (1) the intervention arm, consisting of a guided, spoken mindfulness meditation app; (2) an active control arm, consisting of a progressive muscle relaxation app; and (3) usual care (no app). Participants were followed-up for 6 months. Key feasibility outcomes included the time taken to recruit all patients for the study, adherence, and estimates to be used in the sample size calculation for a subsequent full-scale trial. Upon completion of the feasibility trial we will conduct focus groups to explore app usability and reasons for noncompliance.

Results: Recruitment for MEMPHIS took place between May 2016 and September 2016. The study was closed March 2017 and the report was submitted to the NIHR on October 26, 2017.

Conclusions: This feasibility trial will inform the design of a large multicentered trial to assess the clinical effectiveness of mindfulness meditation delivered via a smartphone app for the treatment of CPP.

Trial Registration: ClinicalTrials.gov: NCT02721108; https://clinicaltrials.gov/ct2/show/NCT02721108 (Archived by WebCite at http://www.webcitation.org/6wLMAkuaU); BioMed Central: ISRCTN10925965; https://www.isrctn.com/ISRCTN10925965 (Archived by WebCite at http://www.webcitation.org/6wLMVLuys).
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http://dx.doi.org/10.2196/resprot.7720DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5789162PMC
January 2018

The lived experience of chronic headache: a systematic review and synthesis of the qualitative literature.

BMJ Open 2017 Dec 15;7(12):e019929. Epub 2017 Dec 15.

Complex Intervention and Social Practice in Health Care Unit, Centre for Primary Care and Public Health, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Coventry, UK.

Objective: To systematically review the qualitative literature of the lived experience of people with a chronic headache disorder.

Background: Chronic headaches affect 3%-4% of the population. The most common chronic headache disorders are chronic migraine, chronic tension-type headache and medication overuse headache. We present a systematic review and meta-ethnographic synthesis of the lived experience of people with chronic headache.

Methods: We searched seven electronic databases, hand-searched nine journals and used a modified Critical Appraisal Skills Programme checklist to appraise study quality. Following thematic analysis we synthesised the data using a meta-ethnographic approach.

Results: We identified 3586 unique citations; full texts were examined for 86 studies and 4 were included in the review. Included studies differed in their foci: exploring, patient-centred outcomes, chronic headache as a socially invisible disease, psychological processes mediating impaired quality of life, and the process of medication overuse. Initial thematic analysis and subsequent synthesis gave three overarching themes: 'headache as a driver of behaviour' (directly and indirectly), 'the spectre of headache' and 'strained relationships'.

Conclusion: This meta-synthesis of published qualitative evidence demonstrates that chronic headaches have a profound effect on people's lives, showing similarities with other pain conditions. There were insufficient data to explore the similarities and differences between different chronic headache disorders.
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http://dx.doi.org/10.1136/bmjopen-2017-019929DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5778309PMC
December 2017

Exploring the perspectives of clinical professionals and support staff on implementing supported self-management for asthma in UK general practice: an IMPART qualitative study.

NPJ Prim Care Respir Med 2017 Jul 18;27(1):45. Epub 2017 Jul 18.

Asthma UK Centre for Applied Research, Usher Institute for Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.

Despite an overwhelming evidence base, supported self-management of asthma is poorly implemented into routine practice. Strategies for implementation must address organisational routines, as well as provide resources for patients and training to improve professionals' skills. We aimed to explore the priority that primary care practices attach to asthma self-management, to describe their existing asthma management routines, and to generate innovative implementation strategies. We recruited 33 participants (23 general practitioners; seven nurses; three administrative staff) from 14 general practices. The 12 interviews and three focus groups were transcribed, coded and analysed thematically. Supported self-management was largely a nurse-led task within clinic-based annual reviews. Barriers included poor attendance at asthma clinics, lack of time, demarcation of roles, limited access to a range of tailored resources, and competing agendas in consultation, often due to multimorbidity. Suggestions for initiatives to improve the provision of supported self-management included emphasising the evidence for benefit (to influence prioritisation), improving teamwork (including team-based education), organisational strategies (including remote consulting) which need to fit within existing practice routines. Technology offers some potential solutions (e.g., improved templates, 'app'-based plans), but must be integrated with the practice information technology systems. Building on these insights, we will now develop a theoretically-based implementation strategy that will address patient, professional, and organisational buy-in, provide team-based education and offer a range of practical options and tools, which can be adapted and integrated within existing routines of individual practices.OVERCOMING THE ORGANISATIONAL BARRIERS TO IMPLEMENTING ASTHMA SELF-MANAGEMENT: Understanding the routines of primary care practices can suggest strategies to implement supported self-management in general practice. Supported self-management of asthma including provision of individual action plans improves patient health and reduces the burden on healthcare services, but is not well implemented in routine practice. As part of a large-scale programme to implement self-management into UK general practice, Hilary Pinnock at the University of Edinburgh and co-workers conducted interviews and focus groups with 33 participants from 14 general practices to explore the organisational routines that hinder or enable professionals to provide support asthma self-management. Poor attendance at asthma clinics, demarcation of roles, lack of time and limited access to tailored resources were identified as specific barriers. Improvements suggested included improved teamwork between doctors and other medical healthcare professionals, comprehensive training, and improvements to IT systems.
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http://dx.doi.org/10.1038/s41533-017-0041-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5515882PMC
July 2017

Understanding the applicability of results from primary care trials: lessons learned from applying PRECIS-2.

J Clin Epidemiol 2017 Oct 17;90:119-126. Epub 2017 Jun 17.

Centre for Primary Care and Public Health, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London E1 2AB, UK.

Objective: To compare two approaches for trial teams to apply PRECIS-2 to pragmatic trials: independent scoring and scoring following a group discussion.

Study Design And Setting: We recruited multidisciplinary teams who were conducting or had conducted trials in primary care in collaboration with the Pragmatic Clinical Trials Unit, Queen Mary University of London. Each team carried out two rounds of scoring on the nine PRECIS-2 domains: first independently using an online version of PRECIS-2 and second following a discussion.

Results: Seven teams took part in the study. Before the discussion, within-team agreement in scores was generally poor and not all raters were able to score all domains; agreement improved after the discussion. The PRECIS-2 wheels suggested that the trials were pragmatic, although some domains were more pragmatic than others.

Conclusion: PRECIS-2 can facilitate information exchange within trial teams. To apply PRECIS-2 successfully, we recommend a discussion between those with detailed understanding of what usual care is for the intervention, the trial's design including operational and technical aspects, and the PRECIS-2 domains. For some cluster-randomized trials, greater insight may be gained by plotting two PRECIS-2 wheels, one at the individual participant level and another at the cluster level.
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http://dx.doi.org/10.1016/j.jclinepi.2017.06.007DOI Listing
October 2017
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