An alternative trial design to overcome validity and recruitment problems in primary care research

BACKGROUND: Although the randomized controlled trial is widely accepted as the best design to investigate new interventions, conducting a trial in primary care may present researchers with many methodological problems. OBJECTIVE: Our aim was to present an alternative trial design to overcome internal validity and recruitment problems. METHODS: In a randomized controlled trial, fatigued employees absent from work were selected among the population of an occupational health service in the South of The Netherlands. Patients randomly assigned to the experimental condition received cognitive behavioural therapy by a research GP near their home address, whereas patients in the control group received no intervention. We describe our considerations for building an alternative design. Research GPs and patients were recruited separately for the study. The pre-randomization design was applied. RESULTS: Nine research GPs performed all the interventions. Seventy-six experimental patients and 75 control patients were selected for study participation. Of these, only six patients in the experimental group and seven patients in the control group withdrew from the study at some point during follow-up. CONCLUSION: Results suggest that recruitment and randomization procedures in the alternative design served their purpose well. The alternative design proposed here might have several advantages compared with conventional trial procedures. However, our design is not widely applicable and there are ethical aspects involved that should be considered. Researchers should address their creativity when trying to minimize the problems they may encounter in designing a study.     

Using value of information analysis to inform publicly funded research priorities

Introduction

The purpose of this article is to demonstrate the application and feasibility of using value of information analysis to help set priorities for research as part of the UK National Health Service (NHS) Health Technology Assessment Programme. Probabilistic decision analysis and value of information methods were applied to a research topic under consideration by the National Coordinating Centre for Health Technology Assessment (NCCHTA), in the UK. The case study presented considers whether long-term, low-dose antibacterial treatment of recurrent urinary tract infections (UTIs) in children is effective and cost effective compared with short-term antibacterial therapy.

Methods

A probabilistic decision-analytic model was developed, within which evidence from published sources was synthesised. Eight subgroups were considered and defined in terms of sex and presence of vesico-ureteral reflux (VUR). Costs were assessed from an NHS perspective, and benefits were expressed as quality-adjusted life-years (QALYs). Simulation methods were used to determine the probability that alternative therapies would be cost effective at a range of threshold values that the NHS may attach to an additional QALY. Value of information analysis was used to quantify the cost of uncertainty associated with the decision about which therapy to adopt, which indicates the maximum value of future research. The feasibility and practicality of using value of information methods to help inform research prioritisation was evaluated.

Results

At a threshold value for an additional QALY of £30 000, long-term antibacterial treatment may be regarded as cost effective for all eight patient groups. There was, however, substantial uncertainty surrounding the choice of antibacterial.

Discussion/conclusion

The use of value of information methods was feasible and could inform research prioritisation for the NHS. In the context of this specific decision faced by the NHS, the results show that long-term low-dose antibacterials for preventing recurrent UTIs may be cost effective, based on current evidence. However, the analysis suggests that further primary research with longer follow-up may be worthwhile, particularly for girls with no VUR.     

Toward an ecosystemic approach to chronic care design and practice in primary care

Despite the increasing prevalence of chronic conditions and multimorbidities, the essential attributes of the structure and delivery of primary care continue to be defined in terms of disease-specific approaches and acute conditions. Effective improvements will require alternative ways of thinking about chronic care design and practice. This essay argues for an ecosystemic understanding of chronic care founded on a communal and a dynamic view of the response of the patient, family, and health professionals to chronic illness. The communal view highlights the cocreative nature of the response to illness and the need to integrate the skills and resources of all the participants; what and how the participants learn in the course of the illness become central to chronic care. The dynamic view draws attention to the unfolding of illness management activities over time and to the need to engage the illness at specific time points or recurring time intervals that have the potential for important change in the experience of the participants. Chronic care would then include design for community, with an emphasis on the patient and family as necessary participants in the health care team. It would also include design for emergent learning and practice whereby health professionals go beyond standardization of care processes to develop new ways to harness the participants' imagination and learn from the changing experience of illness. Health professionals would also learn to cultivate trust, communal engagement, and openness to experimentation that facilitate collective learning, and help sharpen the participants' responsiveness to the emergent.     

Patterns of primary care and mortality among patients with schizophrenia or diabetes: a cluster analysis approach to the retrospective study of healthcare utilization

Background  

Patients with schizophrenia have difficulty managing their medical healthcare needs, possibly resulting in delayed treatment and poor outcomes. We analyzed whether patients reduced primary care use over time, differentially by diagnosis with schizophrenia, diabetes, or both schizophrenia and diabetes. We also assessed whether such patterns of primary care use were a significant predictor of mortality over a 4-year period.     

PHLS primary care consultation--infectious disease and primary care research and service development priorities

In 1999 for the first time the PHLS undertook a questionnaire survey of general practitioners' views of the burden of infectious disease and the priorities for research and development of infectious disease services within the PHLS. Three hundred and seventy-one (38%) of 979 questionnaires mailed to chairs of primary care groups in England, and general practitioners in research networks, were returned. Service areas: computer transfer of laboratory results was considered of greatest priority. Guidance on antibiotic usage, guidance on infectious diseases and education for general practitioners were ranked two, three and four. Burden of infectious disease in primary care: upper respiratory tract infections, tonsillitis/pharyngitis, otitis media/externa and acute cough were placed one, three, four and seven respectively. Urinary tract infections were ranked second and dyspepsia/Helicobacter pylori fifth. Leg ulcers, diarrhoea, genital chlamydia infection and vaginal discharge were other diseases considered to cause a large burden of ill-health. Genital chlamydia, tuberculosis, Helicobacter pylori and meningococci were ranked one, two, three, and five in the NHS opportunity to affect the burden of ill-health. Priorities for improvements to diagnostic tests, evidence on which to base treatment and guidance: chronic fatigue/ME was ranked top in these areas. The other top ten syndromes ranked in order were genital chlamydia infections, antibiotic resistance surveillance, vaginal discharge, leg ulcers, sinusitis, otitis media/externa, dyspepsia/Helicobacter pylori, Creutzfeld Jacob Disease, and tonsillitis. This consultation exercise has highlighted broad areas for future PHLS involvement in primary care. In order to make progress, further consultation is needed with groups of GPs, and other relevant bodies. Particularly for the areas ranked in the top ten, the type of further PHLS involvement needs to be defined. For some syndromes (chronic fatigue and leg ulcers) this may be writing guidance and for others (respiratory tract infections) more treatment trials are required. The purposes and possible methods of communicable disease surveillance in general practice should be the subject of additional consultation.     

Family practices registration networks contributed to primary care research

BACKGROUND AND OBJECTIVE: Family physicians (FP) play a key role in the diagnosis and treatment of health problems in the community and for evidence-based guidance clinical research must be based on primary care data. This paper analyses the state-of-the-art approaches to collection of data and the building of databases in family practice. METHODS: Experience in the Netherlands in family practice-based research networks (PBRNs) is explored in registering and analyzing primary care data, illustrated with four examples of PBRN studies. RESULTS: PBRNs bring together practices and FPs with a research interest to collect data and pursue research under routine patient care conditions. This directs research at relevant questions of family practice. Important features of success are practitioners' ownership of data and the use of data in improving care of patients in the participating practices. International standardization of terminology and definitions in the international classification of primary care improves the scientific quality of data recorded in registration networks and PBRNs. CONCLUSIONS: Through primary care registration networks and PBRNs it is possible to tap-in unselected care of patients and at the same time produce scientifically rigorous data. This enables research that represents the realities of primary care with valid data.     

Global health and primary care research.

A strong primary health care system is essential to provide effective and efficient health care in both resource-rich and resource-poor countries. Although a direct link has not been proven, we can reasonably expect better economic status when the health of the population is improved. Research in primary care is essential to inform practice and to develop better health systems and health policies. Among the challenges for primary care, especially in countries with limited resources, is the need to enhance the research capacity and to engage primary care clinicians in the research enterprise. These caregivers need to be an integral part of the research enterprise so the right questions will be asked, the results from research will be used in practice, and a scholarly and evidence-based approach to primary care will become the norm. The challenge of developing research in primary care can be met only by creating a strong infrastructure. This will include strengthening academic departments, enhancing links to researchers in other fields, improving training programs for future primary care researchers, developing more practice-based primary care research networks, and increasing funding for research in primary care. A greatly increased commitment on the part of international organizations both within and outside of primary care is needed, in particular those organizations involved with funding research. We provide suggestions to improve the global primary care research enterprise for the benefit of the world's population.     

Spatial analysis of elderly access to primary care services

Background  

Admissions for Ambulatory Care Sensitive Conditions (ACSCs) are considered preventable admissions, because they are unlikely to occur when good preventive health care is received. Thus, high rates of admissions for ACSCs among the elderly (persons aged 65 or above who qualify for Medicare health insurance) are signals of poor preventive care utilization. The relevant geographic market to use in studying these admission rates is the primary care physician market. Our conceptual model assumes that local market conditions serving as interventions along the pathways to preventive care services utilization can impact ACSC admission rates.     

Applying research evidence to individuals in primary care: a study using non-rheumatic atrial fibrillation.

BACKGROUND: There is strong research evidence that anticoagulation of patients with nonrheumatic atrial fibrillation reduces the morbidity and mortality of stroke. This evidence is incompletely applied. OBJECTIVES: We aimed to report consequences associated with the intention to apply evidence about anticoagulation for non-rheumatic atrial fibrillation (NRAF) to individuals in general medical practice. METHODS: The study involved prospective structured reporting of the processes of applying evidence about NRAF to individual patients in six general practices in Cambridge. The subjects were patients identified to have NRAF in these practices. The intervention consisted of a practice-based review of evidence and the construction of a practice-owned protocol. This was followed by a review of individual patients' records according to protocol criteria. The main outcomes were indentification of the characteristics of the patients, quantitation of GPs' intention to change treatment, explicit reporting of the reasons for not anticoagulating individuals and time to achieve the practice protocol. RESULTS: The data collected confirmed that patients excluded from the authoritative randomized controlled trials predominate among patients cared for in general medical practice. Practitioners overestimated the prevalence of NRAF in their patients and underestimated the extent to which their current practice offered intervention. Practitioners initially overestimated the amount of change required in patient management. In reviewing their patients' records with the intention of following evidence-based practice, practitioners explicitly described and regarded as appropriate their reasons for not prescribing anticoagulation to certain individuals. The review process was time-consuming and will need to be repeated as further evidence emerges.     

GPs' experiences of primary care mental health research: a qualitative study of the barriers to recruitment

OBJECTIVE: To investigate the perceived barriers among GPs towards introducing participation in randomized controlled trials (RCTs) to patients presenting with depression during consultations. METHODS: Qualitative study using semi-structured interviews. Interviews were recorded using a digital voice recorder, transcribed verbatim and analysed using the Framework Approach. The participants were 41 GPs from five primary care trusts in the South West who were collaborating with the University of Bristol on an RCT recruiting patients with depression. RESULTS: Three themes were identified: (i) concern about protecting the vulnerable patient and the impact on the doctor-patient relationship; (ii) the perceived lack of skill and confidence of GPs to introduce a request for research participation within a potentially sensitive consultation; and (iii) the priority given to clinical and administrative issues over research participation. These themes were underpinned by GPs' observations that consultations with people about depression differed in content, style and perceived difficulty compared to other types of consultations. CONCLUSION: Depressed patients were often viewed as vulnerable and in need of protection and it was seen as difficult and intrusive to introduce research. Patients were not always given the choice to participate in research in the same way that they are encouraged to participate in treatment decision making. A lack of skills in introducing research could be addressed with training through the new Primary Care Research Network. A more radical change in clinician attitudes and policy may be needed in order to give research a higher priority within primary care.