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1.  A rehabilitation intervention to promote physical recovery following intensive care: a detailed description of construct development, rationale and content together with proposed taxonomy to capture processes in a randomised controlled trial 
Trials  2014;15:38.
Background
Increasing numbers of patients are surviving critical illness, but survival may be associated with a constellation of physical and psychological sequelae that can cause ongoing disability and reduced health-related quality of life. Limited evidence currently exists to guide the optimum structure, timing, and content of rehabilitation programmes. There is a need to both develop and evaluate interventions to support and expedite recovery during the post-ICU discharge period. This paper describes the construct development for a complex rehabilitation intervention intended to promote physical recovery following critical illness. The intervention is currently being evaluated in a randomised trial (ISRCTN09412438; funder Chief Scientists Office, Scotland).
Methods
The intervention was developed using the Medical Research Council (MRC) framework for developing complex healthcare interventions. We ensured representation from a wide variety of stakeholders including content experts from multiple specialties, methodologists, and patient representation. The intervention construct was initially based on literature review, local observational and audit work, qualitative studies with ICU survivors, and brainstorming activities. Iterative refinement was aided by the publication of a National Institute for Health and Care Excellence guideline (No. 83), publicly available patient stories (Healthtalkonline), a stakeholder event in collaboration with the James Lind Alliance, and local piloting. Modelling and further work involved a feasibility trial and development of a novel generic rehabilitation assistant (GRA) role. Several rounds of external peer review during successive funding applications also contributed to development.
Results
The final construct for the complex intervention involved a dedicated GRA trained to pre-defined competencies across multiple rehabilitation domains (physiotherapy, dietetics, occupational therapy, and speech/language therapy), with specific training in post-critical illness issues. The intervention was from ICU discharge to 3 months post-discharge, including inpatient and post-hospital discharge elements. Clear strategies to provide information to patients/families were included. A detailed taxonomy was developed to define and describe the processes undertaken, and capture them during the trial. The detailed process measure description, together with a range of patient, health service, and economic outcomes were successfully mapped on to the modified CONSORT recommendations for reporting non-pharmacologic trial interventions.
Conclusions
The MRC complex intervention framework was an effective guide to developing a novel post-ICU rehabilitation intervention. Combining a clearly defined new healthcare role with a detailed taxonomy of process and activity enabled the intervention to be clearly described for the purpose of trial delivery and reporting. These data will be useful when interpreting the results of the randomised trial, will increase internal and external trial validity, and help others implement the intervention if the intervention proves clinically and cost effective.
doi:10.1186/1745-6215-15-38
PMCID: PMC4016544  PMID: 24476530
Critical care; Rehabilitation; Complex intervention
2.  A longitudinal qualitative exploration of healthcare and informal support needs among survivors of critical illness: the RELINQUISH protocol 
BMJ Open  2012;2(4):e001507.
Introduction and background
Survival following critical illness is associated with a significant burden of physical, emotional and psychosocial morbidity. Recovery can be protracted and incomplete, with important and sustained effects upon everyday life, including family life, social participation and return to work. In stark contrast with other critically ill patient groups (eg, those following cardiothoracic surgery), there are comparatively few interventional studies of rehabilitation among the general intensive care unit patient population. This paper outlines the protocol for a sub study of the RECOVER study: a randomised controlled trial evaluating a complex intervention of enhanced ward-based rehabilitation for patients following discharge from intensive care.
Methods and analysis
The RELINQUISH study is a nested longitudinal, qualitative study of family support and perceived healthcare needs among RECOVER participants at key stages of the recovery process and at up to 1 year following hospital discharge. Its central premise is that recovery is a dynamic process wherein patients' needs evolve over time. RELINQUISH is novel in that we will incorporate two parallel strategies into our data analysis: (1) a pragmatic health services-oriented approach, using an a priori analytical construct, the ‘Timing it Right’ framework and (2) a constructivist grounded theory approach which allows the emergence of new themes and theoretical understandings from the data. We will subsequently use Qualitative Health Needs Assessment methodology to inform the development of timely and responsive healthcare interventions throughout the recovery process.
Ethics and dissemination
The protocol has been approved by the Lothian Research Ethics Committee (protocol number HSRU011). The study has been added to the UK Clinical Research Network Database (study ID. 9986). The authors will disseminate the findings in peer reviewed publications and to relevant critical care stakeholder groups.
Article summary
Article focus
This is a nested, qualitative longitudinal study of informal support and healthcare needs among participants in a randomised controlled complex rehabilitative intervention for survivors of critical illness (the RECOVER study).
Its central premise is that recovery is a dynamic process wherein patients' needs evolve over time.
This study will explore patient experience and will identify specific needs at key points in the recovery process, for the purpose of developing timely healthcare interventions.
Key messages
Qualitative studies of recovery are comparatively rare among survivors of critical illness, and longitudinal studies are rarer still.
Qualitative approaches provide rich and detailed insights into patient experience that are often inaccessible by questionnaire based approaches (alone).
Strengths and limitations of this study
A key strength of this study is its analytical strategy. Methodological triangulation with the ‘parent’ study's quantitative outcome data will enhance its interpretation. Theoretical triangulation will (1) produce pragmatic data for the purposes of health services development and (2) enhance theoretical understandings of the recovery process.
A potential limitation, however, is the resource intensity of the analytical process.
doi:10.1136/bmjopen-2012-001507
PMCID: PMC3400070  PMID: 22802422
3.  A randomised controlled trial evaluating a rehabilitation complex intervention for patients following intensive care discharge: the RECOVER study 
BMJ Open  2012;2(4):e001475.
Introduction
Patients who survive an intensive care unit admission frequently suffer physical and psychological morbidity for many months after discharge. Current rehabilitation pathways are often fragmented and little is known about the optimum method of promoting recovery. Many patients suffer reduced quality of life.
Methods and analysis
The authors plan a multicentre randomised parallel group complex intervention trial with concealment of group allocation from outcome assessors. Patients who required more than 48 h of mechanical ventilation and are deemed fit for intensive care unit discharge will be eligible. Patients with primary neurological diagnoses will be excluded. Participants will be randomised into one of the two groups: the intervention group will receive standard ward-based care delivered by the NHS service with additional treatment by a specifically trained generic rehabilitation assistant during ward stay and via telephone contact after hospital discharge and the control group will receive standard ward-based care delivered by the current NHS service. The intervention group will also receive additional information about their critical illness and access to a critical care physician. The total duration of the intervention will be from randomisation to 3 months postrandomisation. The total duration of follow-up will be 12 months from randomisation for both groups. The primary outcome will be the Rivermead Mobility Index at 3 months. Secondary outcomes will include measures of physical and psychological morbidity and function, quality of life and survival over a 12-month period. A health economic evaluation will also be undertaken. Groups will be compared in relation to primary and secondary outcomes; quantitative analyses will be supplemented by focus groups with patients, carers and healthcare workers.
Ethics and dissemination
Consent will be obtained from patients and relatives according to patient capacity. Data will be analysed according to a predefined analysis plan.
Trial registration
The trial is registered as ISRCTN09412438 and funded by the Chief Scientist Office, Scotland.
Article summary
Article focus
The optimum method to maximise the rate and magnitude of recovery following an illness requiring intensive care is unknown.
Rehabilitation is a complex healthcare intervention, which following critical illness involves multiple healthcare professionals including doctors, nurses, physical therapists, dietitians, occupational therapists and other allied professionals.
The RECOVER trial hypothesises that providing more coordinated and intensive rehabilitation, delivered by a specialised generic rehabilitation assistant supported by the existing multidisciplinary team, will improve recovery as judged by a range of patient-centred outcome measures and is cost-effective.
Key messages
The RECOVER study will evaluate whether enhanced rehabilitation is clinically effective and cost-effective in patients enrolled at the time of ICU discharge.
Both positive and negative results will be clinically important in guiding future research directions and health service improvement.
Strengths and limitations of this study
RECOVER was informed by the recommendations of recent evidence-based NICE guidance, and a significant body of research was used to develop the intervention.
The trial has been designed to adhere closely to recent guidance concerning the evaluation of complex healthcare interventions, especially the measurement of process.
A weakness may be the inclusion of patients with a range of illness severity and disability from a general intensive care population; this could miss important effects in patient subgroups.
doi:10.1136/bmjopen-2012-001475
PMCID: PMC3391367  PMID: 22761291
4.  The case study approach 
The case study approach allows in-depth, multi-faceted explorations of complex issues in their real-life settings. The value of the case study approach is well recognised in the fields of business, law and policy, but somewhat less so in health services research. Based on our experiences of conducting several health-related case studies, we reflect on the different types of case study design, the specific research questions this approach can help answer, the data sources that tend to be used, and the particular advantages and disadvantages of employing this methodological approach. The paper concludes with key pointers to aid those designing and appraising proposals for conducting case study research, and a checklist to help readers assess the quality of case study reports.
doi:10.1186/1471-2288-11-100
PMCID: PMC3141799  PMID: 21707982
5.  Is multidisciplinary teamwork the key? A qualitative study of the development of respiratory services in the UK 
Summary
Objectives
Using frameworks, such as the long-term conditions pyramid of healthcare, primary care organizations (PCOs) in England and Wales are exploring ways of developing services for people with long-term respiratory disease. We aimed to explore the current and planned respiratory services and the roles of people responsible for change.
Setting
A purposive sample of 30 PCOs in England and Wales.
Design
Semi-structured telephone interviews with the person responsible for driving the reconfiguration of respiratory services. Recorded interviews were transcribed and coded, and themes identified. The association of the composition of the team driving change with the breadth of services provided was explored using a matrix.
Results
All but two of the PCOs described clinical services developed to address the needs of people with respiratory conditions, usually with a focus on preventing admissions for chronic obstructive pulmonary disease (COPD). Although the majority identified the need to develop a strategic approach to service development and to meet educational needs of primary care professionals, relatively few described clearly developed plans for addressing these issues. Involvement of clinicians from both primary and secondary care was associated with a broad multifaceted approach to service development. Teamwork was often challenging, but could prove rewarding for participants and could result in a fruitful alignment of objectives. The imminent merger of PCOs and overriding financial constraints resulted in a ‘fluid’ context which challenged successful implementation of plans.
Conclusions
While the majority of PCOs are developing clinical services for people with complex needs (principally in order to reduce admissions), relatively few are addressing the broader strategic issues and providing for local educational needs. The presence of multidisciplinary teams, which integrated primary and secondary care clinicians with PCO management, was associated with more comprehensive service provision addressing the needs of all respiratory patients. Future research needs to provide insight into the structures, processes and inter-professional relationships that facilitate development of clinical, educational and policy initiatives which aim to enhance local delivery of respiratory care.
doi:10.1258/jrsm.2009.080356
PMCID: PMC2738772  PMID: 19734535
6.  Mind the gap between policy imperatives and service provision: a qualitative study of the process of respiratory service development in England and Wales 
Background
Healthcare systems globally are reconfiguring to address the needs of people with long-term conditions such as respiratory disease. Primary Care Organisations (PCOs) in England and Wales are charged with the task of developing cost-effective patient-centred local models of care. We aimed to investigate how PCOs in England and Wales are reconfiguring their workforce to develop respiratory services, and the background factors influencing service redesign.
Methods
Semi-structured qualitative telephone interviews with the person(s) responsible for driving respiratory service reconfiguration in a purposive sample of 30 PCOs. Interviews were recorded, transcribed, coded and thematically analysed.
Results
We interviewed representatives of 30 PCOs with diverse demographic profiles planning a range of models of care. Although the primary driver was consistently identified as the need to respond to a central policy to shift the delivery of care for people with long-term conditions into the community whilst achieving financial balance, the design and implementation of services were subject to a broad range of local, and at times serendipitous, influences. The focus was almost exclusively on the complex needs of patients at the top of the long-term conditions (LTC) pyramid, with the aim of reducing admissions. Whilst some PCOs seemed able to develop innovative care despite uncertainty and financial restrictions, most highlighted many barriers to progress, describing initiatives suddenly shelved for lack of money, progress impeded by reluctant clinicians, plans thwarted by conflicting policies and a PCO workforce demoralised by job insecurity.
Conclusion
For many of our interviewees there was a large gap between central policy rhetoric driving workforce change, and the practical reality of implementing change within PCOs when faced with the challenges of limited resources, diverse professional attitudes and an uncertain organisational context. Research should concentrate on understanding these complex dynamics in order to inform the policymakers, commissioners, health service managers and professionals.
doi:10.1186/1472-6963-8-248
PMCID: PMC2632662  PMID: 19055843
7.  Practice organisational characteristics can impact on compliance with the BTS/SIGN asthma guideline: Qualitative comparative case study in primary care 
BMC Family Practice  2008;9:32.
Background
Although the BTS-SIGN asthma guideline is one of the most well known and widely respected guidelines in the world, implementation in UK primary care remains patchy. Building on extensive earlier descriptive work, we sought to explore the way teamwork and inter-professional relationships impact on the implementation of the BTS-SIGN guideline on asthma in general practice.
Methods
Qualitative comparative case study using nine in-depth interviews and 2 focus groups with general practitioners and practice nurses, involved in delivering asthma care. Participants were purposively recruited from practices in a Scottish health board with high and low compliance with the BTS-SIGN asthma guideline.
Results
There was a marked difference in the way respondents from practices with high compliance and respondents from practices with low compliance spoke about the value of guidelines and the challenges of implementing them. On both accounts, the former were more positive than the latter and were able to be more specific about the strategies they used to overcome barriers to implementation. We explored the reason for this difference in response and identified practice organisation, centring on delegation of work to nurses, as a factor mediating the practice's level of compliance. Effective delegation was underpinned by organisation of asthma work among practice members who have the appropriate level of skills and knowledge, know and understand each others' work and responsibilities, communicate well among themselves and trust each others' skills. It was the combination of these factors which made for successful delegation and guideline implementation, not any one factor in isolation.
Conclusion
In our sample of practices, teamwork and organisation of care within practices appeared to impact on guideline implementation and further larger studies are needed to explore this issue further. Isolated interventions such as measures to improve staff's knowledge or increased clinical resource and time, which are currently being considered, are unlikely to be effective unless practices are supported in developing their teams in a way which supports the deployment of these resources.
doi:10.1186/1471-2296-9-32
PMCID: PMC2427031  PMID: 18533013
8.  The Department of Health's research governance framework remains an impediment to multi-centre studies: findings from a national descriptive study 
Objective We describe our experience of using the standard application form, designed to streamline applications for multi-centre research, to seek approval from all primary care organizations (PCOs) in England and Wales to undertake a single telephone interview with a health service manager.
Design We sent applications (n=316), by email to each PCO, or consortium of PCOs, attaching a completed standard application form, the 15 required documents, and the approval we had been granted by the lead NHS organization. We maintained detailed records of the responses to our application, subsequent correspondence, additional paperwork requested, and time spent on the approval process.
Setting The UK Research Governance Framework, which regulates all research conducted in health and social care settings.
Participants All PCOs in England and Wales.
Interventions None.
Main outcome measures Time taken to obtain approval to undertake a telephone interview with a health service manager.
Results We were unable to establish contact with 13 (4%) PCOs. Six months after submitting our application we had received approval from 259/316 (82%) PCOs and were still awaiting a verdict from 41 (13%). The median time to approval was 56 days (IQR 42-72). Overall, an estimated 318 staff-hours were spent completing supplementary forms, providing additional information and chasing up dormant applications.
Conclusions Recent initiatives to ‘streamline’ research governance approval have failed to address the problems that face researchers undertaking multi-centre studies. There is an urgent need to develop a simpler process that allows low risk research to take place without threatening staff morale and endangering the quality of the research outputs. In the meantime, we advise researchers to allow far greater time than might reasonably be envisioned to obtain research governance approval.
PMCID: PMC1861420  PMID: 17470931
9.  Morale among general practitioners: qualitative study exploring relations between partnership arrangements, personal style, and workload 
BMJ : British Medical Journal  2002;325(7356):140.
Objectives
To explore general practitioners' experiences of wellbeing and distress at work, to identify their perceptions of the causes of and solutions to distress, and to draw out implications for improving morale in general practice.
Design
Three stage qualitative study consisting of one to one unstructured interviews, one to one guided interviews, and focus groups.
Setting
Fife, Lothian, and the Borders, South East Scotland.
Participants
63 general practitioner principals.
Results
Morale of general practitioners was explained by the complex interrelations between factors. Three key factors were identified: workload, personal style, and practice arrangements. Workload was commonly identified as a cause of low morale, but partnership arrangements were also a key mediating variable between increasing workload and external changes in general practice on the one hand and individual responses to these changes on the other. Integrated interventions at personal, partnership, and practice levels were seen to make considerable contributions to improving morale. Effective partnerships helped individuals to manage workload, but increasing workload was also seen to take away time and opportunities for practices to manage change and to build supportive and effective working environments.
Conclusions
Solutions to the problem of low morale need integrated initiatives at individual, partnership, practice, and policy levels. Improving partnership arrangements is a key intervention, and rigorous action research is needed to evaluate different approaches.
PMCID: PMC117234  PMID: 12130611
10.  From trial data to practical knowledge: qualitative study of how general practitioners have accessed and used evidence about statin drugs in their management of hypercholesterolaemia 
BMJ : British Medical Journal  1998;317(7166):1130-1134.
Objectives To explore how general practitioners have accessed and evaluated evidence from trials on the use of statin lipid lowering drugs and incorporated this evidence into their practice. To draw out the practical implications of this study for strategies to integrate clinical evidence into general medical practice.
Design Qualitative analysis of semistructured interviews.
Setting General practices in Lothian.
Subjects 24 general practitioners selected to obtain a heterogeneous sample.
Results Respondents were generally aware of the evidence relating to the use of statins in secondary prevention of coronary heart disease, but they were less clear about the evidence in primary prevention. The benefits of statins in secondary prevention were clearer to them and the social and economic issues less complex than was the case for use in primary prevention. Respondents rarely said they appraised the methods and content of trials, rather they judged the trustworthiness of the source of trial evidence and interpreted it within the context of the economic and social factors which impinge on their practice. Moreover, trial data become relevant for routine practice only when underpinned by a consensus on these issues.
Conclusion Strategies to promote incorporation of evidence from clinical trials into everyday practice are likely to be effective if they tap into and build on the process of local consensus building. Strategies such as teaching critical appraisal skills and guideline development may have little effect if they are separated from this process.
Key messagesUse of clinical trial evidence to underpin everyday practice is seen as a key component of a cost effective high quality health serviceStrategies to facilitate use of clinical evidence in practice—for example, appraisal and clinical guidelines—may fail if they are based on unrealistic models of how evidence is assessedIn this study the general practitioners interviewed rarely critically appraised trial data but evaluated trial evidence in terms of its social and economic implicationsLocal consensus about trial findings and their implications strongly influenced incorporation of trial evidence into everyday practiceStrategies to maximise the use of clinical evidence in practice should build on local consensus
PMCID: PMC28696  PMID: 9784451

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