How to embed qualitative research in trials: insights from the feasibility study of the SAFER trial programme.

Qualitative research can enhance the design, conduct and interpretation of trials. Despite this, few trials incorporate qualitative methods, and those that do may not realise their full potential. In this commentary, we highlight how qualitative research can contribute to the design, conduct and day-to-day running of a trial, outlining the working arrangements and relationships that facilitate these contributions. In doing so, we draw on (i) existing frameworks on the role of qualitative research alongside trials and (ii) our experience of integrated qualitative research conducted as part of the feasibility study of the SAFER trial (Screening for Atrial Fibrillation with ECG to Reduce stroke), a cluster randomised controlled trial of screening people aged 70 and above for atrial fibrillation in primary care in England. The activities and presence of the qualitative team contributed to important changes in the design, conduct and day-to-day running of the SAFER feasibility study, and the subsequent main trial, informing diverse decisions concerning trial documentation, trial delivery, timing and content of measures and the information given to participating patients and practices. These included asking practices to give screening results to all participants and not just to 'screen positive' participants, and greater recognition of the contribution of practice reception staff to trial delivery. These changes were facilitated by a 'one research team' approach that underpinned all formal and informal working processes from the outset and maximised the value of both qualitative and trial coordination expertise. The challenging problems facing health services require a combination of research methods and data types. Our experience and the literature show that the benefits of embedding qualitative research in trials are more likely to be realised if attention is given to both structural factors and relationships from the outset. These include sustained and sufficient funding for qualitative research, embedding qualitative research fully within the trial programme, providing shared infrastructure and resources and committing to relationships based on mutual recognition of and respect for the value of different methods and perspectives. We outline key learning for the planning of future trials.Trial registration: Screening for atrial fibrillation with ECG to reduce stroke ISRCTN16939438 (feasibility study); Screening for atrial fibrillation with ECG to reduce stroke - a randomised controlled trial ISRCTN72104369 .

The feasibility of rapid baseline objective physical activity measurement in a natural experimental study of a commuting population.

BACKGROUND: Studies of the effects of environmental interventions on physical activity should include valid measures of physical activity before and after the intervention. Baseline data collection can be difficult when the timetable for introduction of an intervention is outside researchers' control. This paper reports and reflects on the practical issues, challenges and results of rapid baseline objective physical activity measurement using accelerometers distributed by post in a natural experimental study. METHODS: A sample of working adults enrolling for the Commuting and Health in Cambridge study and expressing willingness to wear an activity monitor was selected to undertake baseline accelerometer assessment. Each selected participant received a study pack by post containing the core study questionnaire and an accelerometer to wear for seven consecutive days, and was asked to return their accelerometer and completed questionnaire in person or by post using the prepaid special delivery envelope provided. If a pack was not returned within two weeks of issue, a reminder was sent to the participant. Each participant received up to five reminders by various methods including letter, email, telephone and letter sent by recorded delivery. RESULTS: 95% of participants registering for the study were willing in principle to undertake accelerometer assessment. Using a pool of 221 accelerometers, we achieved a total of 714 issues of accelerometers to participants during a six month period. 116 (16%) participants declined to use the accelerometer after receiving it. Three accelerometers failed, 45 (6% of 714) were lost and many were returned with insufficient data recorded, resulted in 109 (15%) participants re-wearing their accelerometer for a second week of measurement. 550 (77%) participants completed data collection, 478 (87% of 550) to the required standard. A total of 694 reminders were issued to retrieve unreturned accelerometers. More than 90% of accelerometers were retrieved after a maximum of two reminders. CONCLUSIONS: It is feasible to use accelerometers to collect baseline objective physical activity data by post from a large number of participants in a limited time period. However, a substantial pool of devices is required and researchers need to be prepared to make significant efforts to recover some of the devices.

Framework for advancing improvement in primary care.

A consistent feature of effective healthcare delivery systems is a strong and well-integrated primary care sector. This paper presents a framework that describes the key elements of high-performing primary care and the supports required to attain it. The framework was developed by the Quality Improvement and Innovation Partnership in Ontario (now part of Health Quality Ontario) to guide the process of primary care transformation. The first section of this paper presents and describes the framework, the second proposes implementation strategies and the third identifies system-level structures and policies needed to support primary care transformation. The framework has three components: (1) the major constituencies that primary care serves ­ patients, families and their local communities; (2) the desired outcomes of primary care (better health, better care, better value); and (3) the attributes that will enable primary care organizations to attain these outcomes. These attributes are a population focus, patient engagement, partnerships with health and community services, innovation, performance measurement and quality improvement and team-based care.Proposed transformation strategies include building system capacity and capability, ensuring access to resources, providing support from coaches and employing effective spread and sustainability strategies. Broader system-level structures and policies necessary to support and sustain a high-performing and continually improving primary care sector include clear goals; a comprehensive approach to performance measurement; systematic evaluation of innovation; funding incentives aligned with quality outcomes; a system of local primary care organizations; support for inter-professional teams; funding for research to inform primary care policy, management and practice; patient enrolment with primary care providers; and mechanisms to support coordination and integration.

Commuting and health in Cambridge: a study of a 'natural experiment' in the provision of new transport infrastructure.

BACKGROUND: Modifying transport infrastructure to support active travel (walking and cycling) could help to increase population levels of physical activity. However, there is limited evidence for the effects of interventions in this field, and to the best of our knowledge no study has convincingly demonstrated an increase in physical activity directly attributable to this type of intervention. We have therefore taken the opportunity presented by a 'natural experiment' in Cambridgeshire, UK to establish a quasi-experimental study of the effects of a major transport infrastructural intervention on travel behaviour, physical activity and related wider health impacts. DESIGN AND METHODS: The Commuting and Health in Cambridge study comprises three main elements: a cohort study of adults who travel to work in Cambridge, using repeated postal questionnaires and basic objective measurement of physical activity using accelerometers; in-depth quantitative studies of physical activity energy expenditure, travel and movement patterns and estimated carbon emissions using household travel diaries, combined heart rate and movement sensors and global positioning system (GPS) receivers; and a longitudinal qualitative interview study to elucidate participants' attitudes, experiences and practices and to understand how environmental and social factors interact to influence travel behaviour, for whom and in what circumstances. The impacts of a specific intervention - the opening of the Cambridgeshire Guided Busway - and of other changes in the physical environment will be examined using a controlled quasi-experimental design within the overall cohort dataset. DISCUSSION: Addressing the unresolved research and policy questions in this area is not straightforward. The challenges include those of effectively combining different disciplinary perspectives on the research problems, developing common methodological ground in measurement and evaluation, implementing robust quantitative measurement of travel and physical activity behaviour in an unpredictable 'natural experiment' setting, defining exposure to the intervention, defining controls, and conceptualising an appropriate longitudinal analytical strategy.

Development, implementation, and process evaluation of a regional palliative care quality improvement project.

The delivery of optimal palliative care requires an integrated and coordinated approach of many health care providers across the continuum of care. In response to identified gaps in the region, the Palliative Care Integration Project (PCIP) was developed to improve continuity and decrease variability of care to palliative patients with cancer. The infrastructure for the project included multi-institutional and multisectoral representation on the Steering Committee and on the Development, Implementation and Evaluation Working Groups. After review of the literature, five Collaborative Care Plans and Symptom Management Guidelines were developed and integrated with validated assessment tools (Edmonton Symptom Assessment System and Palliative Performance Scale). These project resources were implemented in the community, the palliative care unit, and the cancer center. Surveys were completed by frontline health professionals (defined as health professionals providing direct care), and two independent focus groups were conducted to capture information regarding: 1) the development of the project and 2) the processes of implementation and usefulness of the different components of the project. Over 90 individuals from more than 30 organizations were involved in the development, implementation, and evaluation of the PCIP. Approximately 600 regulated health professionals and allied health professionals who provided direct care, and over 200 family physicians and medical residents, received education/training on the use of the PCIP resources. Despite unanticipated challenges, frontline health professionals reported that the PCIP added value to their practice, particularly in the community sector. The PCIP showed that a network in which each organization had ownership and where no organization lost its autonomy, was an effective way to improve integration and coordination of care delivery.

Palliative Care Integration Project (PCIP) quality improvement strategy evaluation.

This study evaluated the effectiveness of implementation of common assessment tools, collaborative care plans, and symptom management guidelines for cancer patients as a strategy to improve the quality, coordination, and integration of palliative care service across organizations and health care sectors. A pre-post design to measure the impact on symptom management, caregiver burden and satisfaction with care delivery, and service utilization was used. Two cohorts of eligible patients and caregivers completed Edmonton Symptom Assessment Scales, Caregiver Reaction Assessment and FAMCARE Scales and chart audits were conducted. Administrative data from each participating site were examined for utilization trends. Audits of 53 charts preimplementation and 63 postimplementation showed an increase in documentation of pain from 24.5% to 74.6% (P<0.001) of charts. Administrative data showed a decrease in the percentage of patients with at least one emergency room visit from 94.3% to 84.8% (P<0.001), in the percentage of patients with at least one admission to the acute care hospital (P<0.001), and deaths in acute care 43.1%-35.7% (P=0.133). There was minimal change in the intensity of symptoms (P=0.591), and no change in the burden on the caregiver (P=0.086) or caregiver satisfaction with care (P=0.942). This study showed that implementation of common assessment tools, collaborative care plans, and symptom management guidelines across health sectors can result in some increased documentation of symptoms and efficiencies in care. Future projects should consider imbedding a continuous quality improvement methodology and longer timelines into their projects to improve outcomes.

Phospholipid biosynthesis program underlying membrane expansion during B-lymphocyte differentiation.

Stimulated B-lymphocytes differentiate into plasma cells committed to antibody production. Expansion of the endoplasmic reticulum and Golgi compartments is a prerequisite for high rate synthesis, assembly, and secretion of immunoglobulins. The bacterial cell wall component lipopolysaccharide (LPS) stimulates murine B-cells to proliferate and differentiate into antibody-secreting cells that morphologically resemble plasma cells. LPS activation of CH12 B-cells augmented phospholipid production and initiated a genetic program, including elevated expression of the genes for the synthesis, elongation, and desaturation of fatty acids that supply the phospholipid acyl moieties. Likewise, many of the genes in phospholipid biosynthesis were up-regulated, most notably those encoding Lipin1 and choline phosphotransferase. In contrast, CTP:phosphocholine cytidylyltransferase alpha (CCTalpha) protein, a key control point in phosphatidylcholine biosynthesis, increased because of stabilization of protein turnover rather than transcriptional activation. Furthermore, an elevation in cellular diacylglycerol and fatty acid correlated with enhanced allosteric activation of CCTalpha by the membrane lipids. This work defines a genetic and biochemical program for membrane phospholipid biogenesis that correlates with an increase in the phospholipid components of the endoplasmic reticulum and Golgi compartments in LPS-stimulated B-cells.