Cross-sectional studies in prescribing research

A cross-sectional study aims to describe the overall picture of a phenomenon, a situational problem, an attitude or an issue, by asking a cross-section of a given population at one specified moment in time. This paper describes the key features of the cross-sectional survey method. It begins by highlighting the main principles of the method, then discusses stages in the research process, drawing on two surveys of primary care pharmacists to illustrate some salient points about planning, sampling frames, definition and conceptual issues, research instrument design and response rates. Four constraints in prescribing studies were noted. First the newness of the subject meant a low basis of existing knowledge to design a questionnaire. Second, there was no public existing database for the sampling frame, so a pragmatic sampling exercise was used. Third, the definition of a Primary Care Pharmacist (PCP) [in full] and respondents recognition of that name and identification with the new role limited the response. Fourth, a growing problem for all surveys, but particularly with pharmacists and general practitioners (GP) [in full] is the growing danger of survey fatigue, which has a negative impact on response levels.

Reducing medicines waste in the community

There is increasing concern at the amount and cost of prescribed medicines that are unused or wasted and then have to be disposed of. Previous studies have used health promotion and Dispose Unwanted Medicines Properly campaigns targeted at the patient to describe and quantify the annual cost of waste. The reasons patients return unused drugs to pharmacies have also been explored. The paper focuses on patient explanations for not needing medication; categorized as: over-collection in the past, self-management strategies, changes in medical condition, other changes in patient circumstances, or the repeat medicines policy at the surgery. The aim of the original study was to make a measurable change in prescribed medicines with a reduction in medicines wastage, whilst at the same time achieving improved standards of pharmaceutical care. Information on patient needs and behaviour came from consultation in the pharmacy monitoring forms and interview. The study was based on two medical practices in the West Midlands, UK, comparing an outer city and an inner city population. The participants were general practitioners, pharmacists and 350 repeat prescription patients. Prescriptions were issued for two three-month periods. The outcome was that 23.8% of the prescribed items were not dispensed, at a value of £13.1K, 58% of the medications that would be expected to be regularly supplied were collected. The study suggests that closer professional management at the point of dispensing and an understanding of patient experiences can help reduce the amount of unwanted medication collected by patients.

Diabetes service provision:a qualitative study of newly diagnosed Type 2 diabetes patients' experiences and views

Aims: To explore newly diagnosed Type 2 diabetes patients' views about Scottish diabetes services at a time when these services are undergoing a major reorganization. To provide recommendations to maximize opportunities brought by the devolvement of services from secondary to primary healthcare settings. Methods: Qualitative panel study with 40 patients newly diagnosed with Type 2 diabetes, recruited from hospital clinics and general practices in Lothian, Scotland. Patients were interviewed three times over 1 year. The study was informed by grounded theory, which involves concurrent data collection and analysis. Results: Patients were generally satisfied with diabetes services irrespective of the types of care received. Most wanted their future care/review to be based in general practice for reasons of convenience and accessibility, although they dis-liked it when appointments were scheduled for different days. Many said they lacked the knowledge/confidence to know how to manage their diabetes in particular situations, and needed access to healthcare professionals who could answer their questions promptly. Patients expressed a need for primary care professionals who had diabetes expertise, but who had more time and were more accessible than general practitioners. Patients who had encountered practice lead nurses for diabetes spoke particularly positively of these professionals. Conclusions: Nurses with diabetes training are particularly well placed to provide information and support to patients in primary care. Ideally, practices should run 'one-stop' diabetes clinics to provide structured care, with easily accessible dietetics, podiatry and retinopathy screening. Newly diagnosed patients may benefit from being made more aware of specific services provided by charitable organizations such as Diabetes UK. © 2005 Diabetes UK.

Molecular analysis of methicillin-resistant Staphylococcus aureus reveals an absence of plasmid DNA in multidrug-resistant isolates

The number, diversity and restriction enzyme fragmentation patterns of plasmids harboured by 44 multidrug-resistant hospital-acquired methicillin-resistant Staphylococcus aureus (MR-HA-MRSA) isolates, two multidrug-resistant community-acquired MRSA (MR-CA-MRSA), 50 hospital-acquired MRSA (HA-MRSA) isolates (from the University Hospital Birmingham, NHS Trust, UK) and 34 community-acquired MRSA (CA-MRSA) isolates (from general practitioners in Birmingham, UK) were compared. In addition, pulsed-field gel electrophoresis (PFGE) type following SmaI chromosomal digest and SCCmec element type assignment were ascertained for each isolate. All MR-HA-MRSA and MR-CA-MRSA isolates possessed the type II SCCmec, harboured no plasmid DNA and belonged to one of five PFGE types. Forty-three out of 50 HA-MRSA isolates and all 34 CA-MRSA isolates possessed the type IV SCCmec and all but 10 of the type IV HA-MRSA isolates and nine CA-MRSA isolates carried one or two plasmids. The 19 non-multidrug-resistant isolates (NMR) that did not harbour plasmids were only resistant to methicillin whereas all the NMR isolates harbouring at least one plasmid were resistant to at least one additional antibiotic. We conclude that although plasmid carriage plays an important role in antibiotic resistance, especially in NMR-HA-MRSA and CA-MRSA, the multidrug resistance phenotype from HA-MRSA is not associated with increased plasmid carriage and indeed is characterised by an absence of plasmid DNA. © 2005 Federation of European Microbiological Societies. Published by Elsevier B.V. All rights reserved.

Evaluation of the Heart of Birmingham teaching Primary Care Trust (HoBtPCT): My Choice Weight Management Programme:report commissioned by Heart of Birmingham teaching Primary Care Trust

This report details an evaluation of the My Choice Weight Management Programme undertaken by a research team from the School of Pharmacy at Aston University. The My Choice Weight Management Programme is delivered through community pharmacies and general practitioners (GPs) contracted to provide services by the Heart of Birmingham teaching Primary Care Trust. It is designed to support individuals who are ‘ready to change’ by enabling the individual to work with a trained healthcare worker (for example, a healthcare assistant, practice nurse or pharmacy assistant) to develop a care plan designed to enable the individual to lose 5-10% of their current weight. The Programme aims to reduce adult obesity levels; improve access to overweight and obesity management services in primary care; improve diet and nutrition; promote healthy weight and increased levels of physical activity in overweight or obese patients; and support patients to make lifestyle changes to enable them to lose weight. The Programme is available for obese patients over 18 years old who have a Body Mass Index (BMI) greater than 30 kg/m2 (greater than 25 kg/m2 in Asian patients) or greater than 28 kg/m2 (greater than 23.5 kg/m2 in Asian patients) in patients with co-morbidities (diabetes, high blood pressure, cardiovascular disease). Each participant attends weekly consultations over a twelve session period (the final iteration of these weekly sessions is referred to as ‘session twelve’ in this report). They are then offered up to three follow up appointments for up to six months at two monthly intervals (the final of these follow ups, taking place at approximately nine months post recruitment, is referred to as ‘session fifteen’ in this report). A review of the literature highlights the dearth of published research on the effectiveness of primary care- or community-based weight management interventions. This report may help to address this knowledge deficit. A total of 451 individuals were recruited on to the My Choice Weight Management Programme. More participants were recruited at GP surgeries (n=268) than at community pharmacies (n=183). In total, 204 participants (GP n=102; pharmacy n=102) attended session twelve and 82 participants (GP n=22; pharmacy 60) attended session fifteen. The unique demographic characteristics of My Choice Weight Management Programme participants – participants were recruited from areas with high levels of socioeconomic deprivation and over four-fifths of participants were from Black and Minority Ethnic groups; populations which are traditionally underserved by healthcare interventions – make the achievements of the Programme particularly notable. The mean weight loss at session 12 was 3.8 kg (equivalent to a reduction of 4.0% of initial weight) among GP surgery participants and 2.4 kg (2.8%) among pharmacy participants. At session 15 mean weight loss was 2.3 kg (2.2%) among GP surgery participants and 3.4 kg (4.0%) among pharmacy participants. The My Choice Weight Management Programme improved the general health status of participants between recruitment and session twelve as measured by the validated SF-12 questionnaire. While cost data is presented in this report, it is unclear which provider type delivered the Programme more cost-effectively. Attendance rates on the Programme were consistently better among pharmacy participants than among GP participants. The opinions of programme participants (both those who attended regularly and those who failed to attend as expected) and programme providers were explored via semi-structured interviews and, in the case of the participants, a selfcompletion postal questionnaire. These data suggest that the Programme was almost uniformly popular with both the deliverers of the Programme and participants on the Programme with 83% of questionnaire respondents indicating that they would be happy to recommend the Programme to other people looking to lose weight. Our recommendations, based on the evidence provided in this report, include: a. Any consideration of an extension to the study also giving comparable consideration to an extension of the Programme evaluation. The feasibility of assigning participants to a pharmacy provider or a GP provider via a central allocation system should also be examined. This would address imbalances in participant recruitment levels between provider type and allow for more accurate comparison of the effectiveness in the delivery of the Programme between GP surgeries and community pharmacies by increasing the homogeneity of participants at each type of site and increasing the number of Programme participants overall. b. Widespread dissemination of the findings from this review of the My Choice Weight Management Project should be undertaken through a variety of channels. c. Consideration of the inclusion of the following key aspects of the My Choice Weight Management Project in any extension to the Programme: i. The provision of training to staff in GP surgeries and community pharmacies responsible for delivery of the Programme prior to patient recruitment. ii. Maintaining the level of healthcare staff input to the Programme. iii. The regular schedule of appointments with Programme participants. iv. The provision of an increased variety of printed material. d. A simplification of the data collection method used by the Programme commissioners at the individual Programme delivery sites.

An examination of adverse drug reaction reporting to the yellow card scheme

Chief pharmacists in 209 hospitals were surveyed about ADR reporting schemes, the priority given to ADR reporting, and attitudes towards ADR reporting. ADR reporting had a low managerial priority. Local reporting schemes were found to be operating in 37% trusts, but there were few plans to start new schemes. Few problems were discovered by the introduction of pharmacist ADR reporting. Chief pharmacists had concerns about the competence of hospital pharmacists to detect ADRs and were in favour of increased training. Lack of time on wards, and recruitment difficulties were suggested as reasons for hospital pharmacist under-reporting. Teaching hospitals appeared to have an increased interest in ADR reporting. A retrospective analysis of reporting trends within the West Midlands region from 1994, showed increasing or stable reporting rates for most sectors of reporters, except for general practitioners (GPs). The West Midlands region maintained higher ADR reporting rates than the rest of the UK. National reporting figures showed a worrying decline in ADR reports from healthcare professionals. Variation was found in the ADR reporting rates of Acute NHS Hospital Trusts and Primary Care Trusts (PCTs) in the West Midlands region, including correlations with prescribing rates and other PCT characteristics. Qualitative research into attitudes of GPs towards the Yellow Card scheme was undertaken. A series of qualitative interviews with GPs discovered barriers and positive motivators for their involvement in the Yellow Card scheme. A grounded theory of GP involvement in the Yellow Card scheme was developed to explain GP behaviour, and which could be used to inform potential solutions to halt declining rates of reporting. Under-reporting of ADRs continues to be a major concern to those who administer spontaneous reporting schemes.

The impact of drug information on the prescribing of drugs

Using prescription analyses and questionnaires, the way drug information was used by general medical practitioners during the drug adoption process was studied. Three new drugs were considered; an innovation and two 'me-too' products. The innovation was accepted by general practitioners via a contagion process, information passing among doctors. The 'me-too' preparations were accepted more slowly and by a process which did not include the contagion effect. 'Industrial' information such as direct mail was used more at the 'awareness' stage of the adoption process while 'professional' sources of information such as articles in medical journals were used more to evaluate a new product. It was shown that 'industrial' information was preferred by older single practice doctors who did not specialise, had a first degree only and who did not dispense their own prescriptions. Doctors were divided into early and late-prescribers by using the date they first prescribed the innovatory drug. Their approach to drug information sources was further studied and it was shown that the early-prescriber issued slightly more prescriptions per month, had a larger list size, read fewer journals and generally rated industrial sources of information more highly than late-prescribers. The prescribing habits of three consultant rheumatologists were analysed and compared with those of the general practitioners in the community which they served. Very little association was noted and the influence of the consultant on the prescribing habits of general practitioners was concluded to be low. The consultants influence was suggested to be of two components, active and passive; the active component being the most influential. Journal advertising and advertisement placement were studied for one of the 'me-too' drugs. It was concluded that advertisement placement should be based on the reading patterns of general practitioners and not on ad-hoc data gathered by representatives as was the present practice. A model was proposed relating the 'time to prescribe' a new drug to the variables suggested throughout this work. Four of these variables were shown to be significant. These were, the list size, the medical age of the prescriber, the number of new preparations prescribed in a given time and the number of partners in the practice.

The clinical assessment of systemic hypertension in optometric practice

This thesis sets out to examine in detail the condition of systemic hypertension (high Blood Pressure) in relation to optometric practice in the United Kingdom. Systemic hypertension, which is asymptomatic in the early stages, is diagnosed from the Blood Pressure (BP) measurement recorded by a sphygmomanometer and/or from the complications that have developed in target organs. Optometric practice based surveys revealed that diagnosed systemic hypertension was the most prevalent cardiovascular medical condition (20.5%). Measurement of BP of patients in this sample revealed that if an optometrist included sphygmomanometry into the sight examination then at least one patient each day would be referred for suspect systemic hypertension. Optometric opinion felt that the measurement of BP in optometric practice would advance the profession, being appreciated by both patients and General Practitioners (GPs), but was felt to be an unnecessary routine procedure. The present sight examination for the systemic hypertensive is similar to that of the normotensive patient, but may involve an altered fundus examination and a visual field test. The GPs were in favour of optometric BP measurement and a future role in the share care management of the systemic hypertensive. The application of a new pictorial grading scale for the grading of vascular changes associated with pre-malignant systemic hypertension was found to be both accurate and reliable. Clinical trial of the grading scale in optometric practice found positive correlations between BP and increasing severity of the retinal vascular features. The subtle pre-malignant vascular changes require reliable accurate detection and analysis to assist in the management of the systemic hypertensive patient. Vessel width was shown to decrease with increasing age. Image analysis of the A/V ratio, arteriolar tortuosity and focal calibre changes revealed a positive correlation to the patient's BP (p<0.001). The retinal vasculature is relatively stable longitudinally with only minor changes in response to early disease states. Age and elevated BP increased a patient's risk of developing systemic medical conditions over a two-year period. The application of the pictorial grading scale to optometric practice and training the optometrist in the use of sphygmomanometry would improve the management of the systemic hypertensive patient in optometric practice. Future advances in image analysis hold substantial benefits for the detection and monitoring of subtle vascular changes associated with systemic hypertension.

Epidemiology of community-acquired meticillin-resistant Staphylococcus aureus obtained from the UK West Midlands region

Between January 2005 and December 2005, 199 meticillin-resistant Staphylococcus aureus (MRSA) isolates were obtained from nonhospitalised patients presenting skin and soft tissue infections to local general practitioners. The study area incorporated 57 surgeries from three Primary Care Trusts in the Lichfield, Tamworth, Burntwood, North and East Birmingham regions of Central England, UK. Following antibiotic susceptibility testing, pulsed-field gel electrophoresis, Panton-Valentine leukocidin gene detection and SCCmec element assignment, 95% of the isolates were shown to be related to hospital epidemic strains EMRSA-15 and EMRSA-16. In total 87% of the isolate population harboured SCCmec IV, 9% had SCCmec II and 4% were identified as carrying novel SCCmec IIIa-mecI. When mapped to patient home postcode, a diverse distribution of isolates harbouring SCCmec II and SCCmec IV was observed; however, the majority of isolates harbouring SCCmec IIIa-mecI were from patients residing in the north-west of the study region, highlighting a possible localised clonal group. Transmission of MRSA from the hospital setting into the surrounding community population, as demonstrated by this study, warrants the need for targeted patient screening and decolonisation in both the clinical and community environments.

Statnote 32 : the partial correlation coefficient

In previous statnotes, the application of correlation and regression methods to the analysis of two variables (X,Y) was described. The most important statistic used to measure the degree of correlation between two variables is Pearson’s ‘product moment correlation coefficient’ (‘r’). The correlation between two variables may be due to their common relation to other variables. Hence, investigators using correlation studies need to be alert to the possibilities of spurious correlation and the methods of ‘partial correlation’ are one method of taking this into account. This statnote applies the methods of partial correlation to three scenarios. First, to a fairly obvious example of a spurious correlation resulting from the ‘size effect’ involving the relationship between the number of general practitioners (GP) and the number of deaths of patients in a town. Second, to the relationship between the abundance of the nitrogen-fixing bacterium Azotobacter in soil and three soil variables, and finally, to a more complex scenario, first introduced in Statnote 24involving the relationship between the growth of lichens in the field and climate.

Patients’ and physicians’ experiences of atrial fibrillation and anticoagulation therapy:a qualitative journey

Background: Oral anticoagulation (OAC) reduces stroke risk in patients with atrial fibrillation (AF) however it is often underutilized and sometimes refused by patients. This programme of work included a meta-synthesis and two inter-linking studies aiming to explore patients’ and physicians’ experiences of AF and OAC. Methods: A meta-synthesis of qualitative evidence was conducted which informed the empirical work. Semi-structured individual interviews were utilised. Study 1: Three AF patient sub-groups were interviewed; accepted (n=4), refused (n=4), or discontinued (n=3) warfarin. Study 2: Four physician sub-groups (n=4 each group) prescribing OAC to AF patients were interviewed: consultant cardiologists, consultant general physicians, general practitioners and cardiology registrars. Data was analysed using interpretative phenomenological analysis. Results: Study 1: Three over-arching themes comprised patients’ experiences: (1) the initial consultation, (2) life after the consultation, and (3) patients’ reflections. Patients commented on the relief and reassurance experienced during the consultation but they perceived the decision making process mostly led by the physician. Lack of education and take-home materials distributed during the initial consultation was highlighted. Patients who had experienced stroke themselves or were caregivers, were more receptive to education aimed towards stroke risk reduction rather than bleeding risk. Warfarin monitoring was challenging for patients, however some patients perceived it as beneficial as it served to enhance patient-physician relationship. Study 2: Two over-arching themes emerged from physicians’ experiences: (1) communicating information and (2) challenges with OAC prescription for AF. Physicians’ approach to the consultation style shifted through a continuum of compliance-adherence-concordance during the consultation. They aimed for concordance, however challenges such as time and the perceived patient trust in them as the expert, led to physicians adopting a paternalistic approach. Physicians also pointed out challenges associated with guideline adherence and the need to adopt a multi-disciplinary approach, where other health professionals could provide on-going education. Conclusion: This programme of work has illustrated the benefit of taking an in depth phenomenological approach to understanding the lived experience of the physician-patient consultation. Together with the meta-synthesis, this work has strengthened the evidence base and demonstrated that there is a need to target patients' and physicians' ability to communicate with each other in a comprehensible way.

Healthcare professional experiences and attitudes on unlicensed/off-label paediatric prescribing and paediatric clinical trials

To investigate the knowledge and views of a range of healthcare professionals (consultant paediatricians, general practitioners (GPs), community pharmacists and paediatric nurses) regarding the use of unlicensed/off-label medicines in children and the participation of children in clinical trials.

The influence of patient's age on clinical decision-making about coronary heart disease in the USA and the UK

This paper examines UK and US primary care doctors' decision-making about older (aged 75 years) and midlife (aged 55 years) patients presenting with coronary heart disease (CHD). Using an analytic approach based on conceptualising clinical decision-making as a classification process, it explores the ways in which doctors' cognitive processes contribute to ageism in health-care at three key decision points during consultations. In each country, 56 randomly selected doctors were shown videotaped vignettes of actors portraying patients with CHD. The patients' ages (55 or 75 years), gender, ethnicity and social class were varied systematically. During the interviews, doctors gave free-recall accounts of their decision-making. The results do not establish that there was substantial ageism in the doctors' decisions, but rather suggest that diagnostic processes pay insufficient attention to the significance of older patients' age and its association with the likelihood of co-morbidity and atypical disease presentations. The doctors also demonstrated more limited use of 'knowledge structures' when diagnosing older than midlife patients. With respect to interventions, differences in the national health-care systems rather than patients' age accounted for the differences in doctors' decisions. US doctors were significantly more concerned about the potential for adverse outcomes if important diagnoses were untreated, while UK general practitioners cited greater difficulty in accessing diagnostic tests.

Patients' and health professionals' views on primary care for people with serious mental illness:focus group study

Objective: To explore the experience of providing and receiving primary care from the perspectives of primary care health professionals and patients with serious mental illness respectively. Design: Qualitative study consisting of six patient groups, six health professional groups, and six combined focus groups. Setting: Six primary care trusts in the West Midlands. Participants: Forty five patients with serious mental illness, 39 general practitioners (GPs), and eight practice nurses. Results: Most health professionals felt that the care of people with serious mental illness was too specialised for primary care. However, most patients viewed primary care as the cornerstone of their health care and preferred to consult their own GP, who listened and was willing to learn, rather than be referred to a different GP with specific mental health knowledge. Swift access was important to patients, with barriers created by the effects of the illness and the noisy or crowded waiting area. Some patients described how they exaggerated symptoms ("acted up") to negotiate an urgent appointment, a strategy that was also employed by some GPs to facilitate admission to secondary care. Most participants felt that structured reviews of care had value. However, whereas health professionals perceived serious mental illness as a lifelong condition, patients emphasised the importance of optimism in treatment and hope for recovery. Conclusions: Primary care is of central importance to people with serious mental illness. The challenge for health professionals and patients is to create a system in which patients can see a health professional when they want to without needing to exaggerate their symptoms. The importance that patients attach to optimism in treatment, continuity of care, and listening skills compared with specific mental health knowledge should encourage health professionals in primary care to play a greater role in the care of patients with serious mental illness.

Managing crisis:the role of primary care for people with serious mental illness

Background and Objectives: More than 30% of patients with serious mental illness in the United Kingdom now receive all their health care solely from primary care. This study explored the process of managing acute mental health crises from the dual perspective of patients and primary care health professionals. Methods: Eighteen focus groups involving 45 patients, 39 general practitioners, and eight practice nurses were held between May and November 2002 in six Primary Care Trusts across the British West Midlands. The topic guide explored perceptions of gold standard care, current issues and critical incidents in receiving/providing care, and ideas on improving services. Results: Themes relevant to the management of acute crisis included issues of process, such as access, advocacy, communication, continuity, and coordination of care; the development of more structured care that might reduce the need for crisis responses; and issues raised by the development of a more structured approach to care. Conclusions: Access to services is a complicated yet crucial feature of managing care in a crisis, with patients identifying barriers at the level of primary care and health professionals at the interface with secondary care. The development of more structured systems as a solution may generate its own ethical and pragmatic challenges.