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Biomedical subjects

T Schofield

Publications and source records attributed to T Schofield.

At least 19 recordsLinked to original sources

Ethics of evidence based medicine in the primary care setting.

Evidence based medicine has had an increasing impact on primary care over the last few years. In the UK it has influenced the development of guidelines and quality standards for clinical practice and the allocation of resources for drug treatments and other interventions. It has informed the thinking around patient involvement in decision making with the concept of evidence based patient choice. There are, however, concerns among primary care clinicians that evidence based medicine is not always relevant to primary care and that undue emphasis placed on it can lead to conflict with a clinician's duty of care and respect for patient autonomy. In this paper we consider the impact of evidence based medicine on primary care, and the ethical implications of its increasing prominence for clinicians and managers in primary care.

Decision Making↗

RCGP Quality Team Development programme: an illuminative evaluation.

BACKGROUND: There is increasing interest in quality initiatives that are locally owned and delivered, team based, multiprofessional, and formative. The Royal College of General Practitioners' Quality Team Development (QTD) programme is one such initiative aimed at developing primary healthcare teams and their services. AIMS: To evaluate QTD from the perspective of participants and assessors. SETTING: UK primary health care. DESIGN AND METHOD: Twelve of 14 practices and all four primary care organisations (PCOs) approached agreed to participate. Thirty four semi-structured interviews were conducted with key stakeholders. The interviews were taped, transcribed, and analysed using the constant comparative method. RESULTS: The QTD programme appears to be highly valued by participating organisations. Practice based respondents perceived it as acceptable and feasible, and reported positive changes in teamwork and patient services. They valued its formative, participative, and multiprofessional nature, especially the peer review element. PCOs saw QTD as a method of delivering on prevailing national policies on clinical quality and modernization agendas as well as promoting interorganizational collaboration. The main concerns raised were the workload, particularly for assessors, and maintaining the quality of the assessments and the programme. CONCLUSION: This qualitative study suggests positive benefits for participants in the QTD programme. However, such practices are a self-selecting innovative minority. Further research is needed on more typical practices to identify barriers to their participation in QTD or other formative, team based quality improvement programmes.

Attitude of Health Personnel↗

In vitro versus in vivo concordance: a case study of the replacement of an animal potency test with an immunochemical assay.

Early in its development, the potency of Merck's recombinant hepatitis B vaccine, RECOMBIVAX HB, was monitored using an assay performed in mice. A specification was determined to be the lowest potency which induced acceptable response in clinical trials. As a post-licensing commitment, Merck was asked to replace its mouse potency assay with an in vitro procedure for product release in the US market. Early studies with a commercial enzyme immunoassay (EIA) yielded highly variable results. That assay, combined with a sample pretreatment step, proved more dependable and predictive of potency in the mouse assay. Based on measurements made on manufactured materials, combined with experiments contrived to yield a wide range of reactivity in the two assays, concordance was established between the EIA and the mouse potency assay. This concordance was used to calibrate a specification for the in vitro assay that is predictive of a satisfactory response in vivo. Data from clinical trials established a correspondence between human immunogenicity and these potency markers.

Animal Testing Alternatives↗

Cluster randomised controlled trial to compare three methods of promoting secondary prevention of coronary heart disease in primary care.

OBJECTIVE: To assess the effectiveness of three different methods of promoting secondary prevention of coronary heart disease in primary care. DESIGN: Pragmatic, unblinded, cluster randomised controlled trial. SETTING: Warwickshire. SUBJECTS: 21 general practices received intervention; outcome measured in 1906 patients aged 55-75 years with established coronary heart disease. INTERVENTIONS: Audit of notes with summary feedback to primary health care team (audit group); assistance with setting up a disease register and systematic recall of patients to general practitioner (GP recall group); assistance with setting up a disease register and systematic recall of patients to a nurse led clinic (nurse recall group). MAIN OUTCOME MEASURES: At 18 months' follow up: adequate assessment (defined) of 3 risk factors (blood pressure, cholesterol, and smoking status); prescribing of hypotensive agents, lipid lowering drugs, and antiplatelet drugs; blood pressure, serum cholesterol level, and plasma cotinine levels. RESULTS: Adequate assessment of all 3 risk factors was much more common in the nurse and GP recall groups (85%, 76%) than the audit group (52%). The advantage in the nurse recall compared with the audit group was 33% (95% confidence interval 19% to 46%); in the GP recall group compared with the audit group 23% (10% to 36%), and in the nurse recall group compared with the GP recall group 9% (-3% to 22%). However, these differences in assessment were not reflected in clinical outcomes. Mean blood pressure (148/80, 147/81, 148/81 mm Hg), total cholesterol (5.4, 5.5, 5.5 mmol/l), and cotinine levels (% probable smokers 17%, 16%, 19%) varied little between the nurse recall, GP recall, and audit groups respectively, as did prescribing of hypotensive and lipid lowering agents. Prescribing of antiplatelet drugs was higher in the nurse recall group (85%) than the GP recall or audit groups (80%, 74%). After adjustment for baseline levels, the advantage in the nurse recall group compared with the audit group was 10% (3% to 17%), in the nurse recall group compared with the GP recall group 8% (1% to 15%) and in the GP recall group compared with the audit group 2% (-6% to 10%). CONCLUSIONS: Setting up a register and recall system improved patient assessment at 18 months' follow up but was not consistently better than audit alone in improving treatment or risk factor levels. Understanding the reasons for this is the key next step in improving the quality of care of patients with coronary heart disease.

Aged↗

Dissolved air flotation in drinking water production.

Dissolved Air Flotation (DAF) has become increasingly important in the field of potable water treatment, as a preferred option for treating upland and stored lowland waters. This paper outlines the development of dissolved air flotation (DAF) in potable water treatment, the benefits and disadvantages and the recent advances that has taken the process technology from an art to a science.

Air↗

Understanding men's health and illness: a gender-relations approach to policy, research, and practice.

Men's health has emerged as an important public concern that may require new kinds of healthcare interventions and increased resources. Considerable uncertainty and confusion surround prevailing understandings of men's health, particularly those generated by media debate and public policy, and health research has often operated on oversimplified assumptions about men and masculinity. A more useful way of understanding men's health is to adopt a gender-relations approach. This means examining health concerns in the context of men's and women's interactions with each other, and their positions in the larger, multidimensional structure of gender relations. Such an approach raises the issue of differences among men, which is a key issue in recent research on masculinity and an important health issue. The gender-relations approach offers new ways of addressing practical issues of healthcare for men in college environments.

Gender Identity↗

An assessment of morbidity registers for coronary heart disease in primary care. ASSIST (ASSessment of Implementation STrategy) trial collaborative group.

BACKGROUND: Organised care delivered systematically to all patients with established coronary heart disease (CHD) can reduce their risk factors and improve their quality of life. Therefore, identifying all patients with established CHD in a general practice population is an important first step for delivering this effective healthcare. However, there is little information on how registers are compiled, the factors that predict inclusion on the register or the relationship between registration and level of care provided. AIM: To assess the completeness of morbidity registers for CHD in primary care, the factors that predict inclusion on the register, and the relationship between registration and level of care provided. METHOD: Observational study at baseline of 1979 patients aged 55 to 75 years with established CHD in 18 general practices recruited for a cluster randomised controlled trial. RESULTS: The proportion of CHD patients correctly identified on practice morbidity registers varied from 29.3% to 100%. Four factors were significantly and independently associated with being on a register: a relevant surgery contact since diagnosis (OR = 2.1, 95% CI = 1.6%-2.9%); a relevant repeat prescription since diagnosis (OR = 1.6, 95% CI = 1.1%-2.3%); a diagnosis of myocardial infarction (OR = 1.5, 95% CI = 1.2%-1.9%); and a revascularisation procedure (OR = 1.5, 95% CI = 1.1%-2.0%). Inclusion on a register was strongly associated with being adequately assessed (i.e. assessed for smoking status, blood pressure, and cholesterol) (OR = 1.8, 95% CI = 1.3%-2.3%) and with treatment with aspirin or a lipid-lowering agent (OR = 1.4 for each agent). CONCLUSION: A wide variation in registration levels between practices exists. There is evidence that practices using multiple methods of case detection achieve higher levels of registration. The association between registration and better care does not prove causality but an effective call-recall system is impossible without complete registration.

Aged↗

Validation of assays for use with combination vaccines.

A general methodology is presented for the validation of assays used for testing combination vaccines. The presentation is detailed and technical as our intention is to address challenges that we have encountered in the design and statistical analysis of assay validation studies. There are several noteworthy features which render the approach particularly useful in practice. It employs a statistical experimental design approach to the investigation of assay ruggedness with respect to manufacturing variability; it makes use of the assay variability results to determine the level of test-run replication necessary to achieve precision compatible with the product specifications; and, it provides a generic approach to assay validation. With combination vaccines, as with other pharmaceuticals, the analytical methods for release and stability must be validated early in the development programme Several things, though, distinguish this task with combination vaccines: (1) assays are typically pre-existing and often have been validated for use with an established sample matrix, e.g. a monovalent formulation; (2) sample matrices are complex and therefore more subject to manufacturing variability and more likely to cause assay interferences; and (3) the analytical workload is considerable due to the number of antigens. The methodology presented here was developed jointly by Merck Research Laboratories (West Point, PA) and Pasteur Mérieux Connaught, Inc. (Swiftwater, PA). Many of the issues discussed here have application outside of combination vaccines and are common features of all assay validations.

Biological Assay↗

Communication teaching and assessment in medical education: an international consensus statement. Netherlands Institute of Primary Health Care.

The importance of communication between doctors and patients has been well established, and there is growing acceptance of the need to teach and assess communication skills in medical schools. Faculty meeting at a consensus workshop during the International Conference on Teaching Communication in Medicine (Oxford, July 1996) generated a series of recommendations for developing and implementing teaching and assessment programmes. The points were refined in subsequent discussions with other interested groups, and endorsed in their current form by a workshop of teachers attending the Communication in Health Care Conference organized by NIVEL, the Netherlands Institute of Primary Health Care (Amsterdam, June 1998). While focused on medical schools, the eight recommendations highlighted in this consensus statement are also relevant to both graduate and continuing medical education programmes: (1) teaching and assessment should be based on a broad view of communication in medicine; (2) communication skills teaching and clinical teaching should be consistent and complementary; (3) teaching should define, and help students achieve, patient-centred communication tasks; (4) communication teaching and assessment should foster personal and professional growth; (5) there should be a planned and coherent framework for communication skills teaching; (6) students' ability to achieve communication tasks should be assessed directly; (7) communication skills teaching and assessment programmes should be evaluated; (8) faculty development should be supported and adequately resourced.

Clinical Competence↗

Comparison of gpELISA and neutralizing antibody responses to Oka/Merck live varicella vaccine (Varivax) in children and adults.

A comparison was made of antibody responses generated to live varicella (Oka/Merck) vaccine (Varivax) produced during three different manufacturing campaigns to evaluate the quality of the antibody responses and demonstrate consistency of the manufacturing process. Anti-varicella zoster virus (VZV) antibody titers were measured by an enhanced neutralization assay and VZV glycoprotein-based enzyme-linked immunosorbent assay (gpELISA). For sera taken from children who had received one dose of vaccine an excellent linear concordance in titers was observed between the two assays. Sera from adults who had received two doses demonstrated continuing increased neutralization at high gpELISA titers. The immunogenicity measured by the two assays demonstrates that the overall performance of the vaccine was very similar over the three production series.

Adult↗

Health promotion in primary care: physician-patient communication and decision making about prescription medications.

To examine health promotion in a primary-care context, we studied perceived and actual communication in 271 consultations between general practitioners and patients in Oxford (England). Although health promotion is a term usually reserved for public-health or wellness programs, a health promotion perspective enriches the examination of communication in physician-patient interactions by emphasizing issues of empowerment, competence and control. Accordingly, we are interested in how communication during medical encounters can improve patients' abilities to exercise appropriate control over their health. A major factor in enabling patients to increase control over their health involves developing their competencies for making decisions and enacting behaviors that can lead to desired, and attainable, health outcomes. This report focuses on communication and decision making about prescription medications, since whether and how to use medications are among the most common and important decisions in which patients can participate. Five instruments were employed to collect data about physicians, patients and their consultations: a Video Analysis, which allowed assessment of actual communication behavior; a Patient Questionnaire designed to gauge perceptions of the encounter and collect demographic information; a Medical-Record Review, which provided information on utilization, diagnosis and treatment; a Telephone Interview, conducted 14 days after the consultation to obtain follow-up information (e.g. experience with the prescribed medication); and a Doctor Questionnaire that focused on attitudes toward consultations and patients. With respect to communication about prescription medications, physicians most frequently mentioned product name (78.2% of consultations) and instructions for use (86.7% of consultations). Patients were extremely passive, rarely offering their opinion or initiating discussion about any aspect of the treatment. We suggest that improving patients' decision-making competencies may require more discussion of benefits and risks, as well as discussion of patients' opinions about the prescribed medications and their abilities to follow through with the treatment plans. The research design proved useful in highlighting discrepancies between perceived and actual communication. Physicians tended to overestimate the extent to which they discussed patients' ability to follow the treatment plan, elicited patients' opinion about the prescribed medication and discussed risks of the medication. And, 24.3% of the patients left the consultation with an 'illusion of competence', a belief that important topics had been discussed when, in fact, they had not been mentioned at all. The pattern of results illustrates the complexity of health promotion in primary care, and underscores the importance of attending to both perceived and actual communication in medical encounters.

Adolescent↗

Sensitive assays for hepatitis A antibodies.

Two commercial assay kits for detecting antibody to hepatitis A virus (anti-HAV) have been modified in order to increase their sensitivity. These modifications are made by less dilution of the test serum, in the case of Abbott HAVAB-M assay, or by an increase in the volumetric ratio of the test serum to the labeled anti-HAV in the case of the Abbott HAVAB assay. These modifications result in 5- to 20-fold increases in test sensitivity and enable the detection of anti-HAV at 2-3 weeks following vaccination. The earlier detection of anti-HAV is important to vaccine development in assuring the presence of antibody levels in travelers sooner after vaccination.

Adult↗