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.     

Developing a community-based neonatal care intervention: a health facility assessment to inform intervention design

Community-based interventions are an important way of improving health in low-income countries. A necessary prerequisite for the design of such interventions is an understanding of the local health system. This will inform intervention design, help ensure the community-intervention forms part of a continuum of care, and provide information about health system strengthening activities that may be necessary for success. Such formative research processes, however, are seldom reported in the literature. We present the results of a health facility assessment used in the design stage of Newhints, a community-based intervention to improve neonatal survival in rural Ghana. We illustrate the methodology, findings and how these were used to inform the design and implementation of Newhints. The assessment involved key informant interviews with staff members at seven health facilities within the study area, including a brief inventory of available drugs and equipment. The key informant interviews identified that practices and health promotion messages at the health facilities were not consistent with one of the key target behaviours of the Newhints intervention - thermal care through delayed infant bathing. Health workers were bathing neonates soon after delivery and also advising women to do the same, which is a potential cause of hypothermia for the newborn. We found that health centres other than large district hospitals were ill-equipped to treat serious complications of labour or illness in the newborn, which had implications for advice on health seeking behaviour within the intervention. As a result of the health facility assessment, it was deemed necessary to undertake both health worker training and sensitisation activities. We demonstrate that important information can be yielded from a relatively simple health facility assessment involving key informant interviews.     

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.     

Gender,citizenship and dementia care: a scoping review of studies to inform policy and future research

Gender is a neglected dimension in public discourse related to people with dementia. Those living with this condition are typically portrayed in policies and strategies in gender neutral terms as ‘people with dementia’ and ‘family carers’ as if gender does not matter, when clearly it does. The purpose of this scoping review was to take stock of knowledge about gender differences in relation to dementia care to inform policy and future research. The work is grounded in a feminist perspective to citizenship, as this provide a lens with which to expose and examine gendered assumptions within dementia studies. A search of four databases, including CINAHL, Web of Science, Medline and Cochrane was conducted using systematic techniques between May and July 2014. A repeat search was conducted in February 2015. We found a significant amount of valuable research concerned with gender differences in relation to dementia care published from 1990 to 2014; the majority of which lacks a feminist citizenship perspective. Moreover, a disproportionate number of studies focused solely on caregivers rather than citizens with dementia. As such, questions about gender equality are not being raised and the voices of men and women with dementia are silent. Thus we argue for increased gender‐sensitivity in policy making and recommend that social scientists inject a feminist citizenship perspective into their work.     

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.     

The cost of primary care research

A significant portion of research project costs is incurred before the receipt of grant funds. This poses a problem for the initiation of primary care research, especially in community practice settings. Potential investigators need financial support for staff time, training, pilot work, and grant proposal writing if primary care researchers are to compete successfully for grant funds. To find this support, we need to understand and eventually quantify the actual costs of research with attention to those that are incurred before the receipt of grant funds. We outline 10 phases of the research process and provide a model for understanding where costs are incurred and by whom. Costs include those associated with maintaining practice interest in research, supporting practice participation, and disseminating research findings. They may be incurred by either an academic center or a research network, by the practices and physicians themselves, or by an extramural funding source. The needed investment for initiating primary care research can be itemized and, with further research, quantified. This will enhance the arguments for capital investments in the primary care research enterprise.     

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.