Research fraud: issues of which practitioners should be aware.

Treatment and care given to patients should be evidence-based, but research results based on fraudulent findings can have a serious impact on care. This paper examines how fraud may be perpetuated and discusses standards for robust research.

Prevalence of left ventricular systolic dysfunction and heart failure in high risk patients: community based epidemiological study.

OBJECTIVES: To determine the prevalence of left ventricular systolic dysfunction, and of heart failure due to different causes, in patients with risk factors for these conditions. DESIGN: Epidemiological study, including detailed clinical assessment, electrocardiography, and echocardiography. SETTING: 16 English general practices, representative for socioeconomic status and practice type. PARTICIPANTS: 1062 patients (66% response rate) with previous myocardial infarction, angina, hypertension, or diabetes. MAIN OUTCOME MEASURES: Prevalence of systolic dysfunction, both with and without symptoms, and of heart failure, in groups of patients with each of the risk factors. RESULTS: Definite systolic dysfunction (ejection fraction <40%) was found in 54/244 (22.1%, 95% confidence interval 17.1% to 27.9%) patients with previous myocardial infarction, 26/321 (8.1%, 5.4% to 11.6%) with angina, 7/388 (1.8%, 0.7% to 3.7%) with hypertension, and 12/208 (5.8%, 3.0% to 9.9%) with diabetes. In each group, approximately half of these patients had symptoms of dyspnoea, and therefore had heart failure. Overall rates of heart failure, defined as symptoms of dyspnoea plus objective evidence of cardiac dysfunction (systolic dysfunction, atrial fibrillation, or clinically significant valve disease) were 16.0% (11.6% to 21.2%) in patients with previous myocardial infarction, 8.4% (5.6% to 12.0%) in those with angina, 2.8% (1.4% to 5.0%) in those with hypertension, and 7.7% (4.5% to 12.2%) in those with diabetes. CONCLUSION: Many people with ischaemic heart disease or diabetes have systolic dysfunction or heart failure. The data support the need for trials of targeted echocardiographic screening, in view of the major benefits of modern treatment. In contrast, patients with uncomplicated hypertension have similar rates to the general population.

Impact of heart failure and left ventricular systolic dysfunction on quality of life: a cross-sectional study comparing common chronic cardiac and medical disorders and a representative adult population.

BACKGROUND: Heart failure and left ventricular systolic dysfunction (LVSD) are increasingly common disorders, with outcomes worse than many cancers. Evidence-based therapies, such as ACE inhibitors and beta-blockers, improve prognosis and symptoms, and reduce healthcare expenditure. However, despite the high prevalence and malignant prognosis, few studies have reported the impact of heart failure and LVSD on overall quality of life and, more crucially, have not researched the elderly or those in the community. METHODS: All patients attending the Echocardiographic Heart of England Screening (ECHOES) study of the prevalence of heart failure and LVSD in the community were assessed by clinical history and examination, electrocardiogram and echocardiography, and also completed the SF36 health status questionnaire. Quality of life in patients found to have heart failure, LVSD, and other cardiac and medical conditions are compared with the randomly selected general population sample. Data are generalisable to the UK. RESULTS: 6162 people in the community were screened in the ECHOES study, of whom 5961 (97%) completed the SF36. The health perceptions of 3850 people aged 45 years or older selected randomly from the population were compared with those of 426 patients diagnosed as having definite heart failure. Those with heart failure had significant impairment of all the measured aspects of physical and mental health, in addition to declines in physical functioning. Significantly worse impairment was found in those with more severe heart failure by NYHA class: indeed, NYHA functional class was closely correlated to SF36 score. Patients with asymptomatic left ventricular dysfunction and patients rendered asymptomatic by treatment had similar scores to the random population sample. Those with heart failure reported more severe physical impairment of quality of life than people giving a history of chronic lung disease or arthritis, with less impact on mental health than patients reporting depression. CONCLUSIONS: Patients with heart failure have statistically significant impairment of all aspects of quality of life, not simply physical functioning. The physical (role and functioning) health burden was significantly greater than that suffered in other serious common chronic disorders, whether cardiac or other systems. Optimising treatment to improve NYHA class appears to improve perceptions of quality of life for patients with heart failure. Given the dramatic decline in quality of life with heart failure, this end-point should be a much more important target for healthcare interventions, especially treatments such as ACE inhibitors and beta-blockers that are shown to improve quality of life.

Reliability of N-terminal pro-brain natriuretic peptide assay in diagnosis of heart failure: cohort study in representative and high risk community populations.

OBJECTIVE: To investigate the performance of a novel assay for N-terminal pro-brain natriuretic peptide (NT-proBNP) in diagnosing heart failure in various randomly selected general and high risk community populations. DESIGN: Community cohort study (substudy of the echocardiographic heart of England screening study). SETTING: Four randomly selected general practices in the West Midlands of England. PARTICIPANTS: 591 randomly sampled patients over the age of 45, stratified for age and socioeconomic status and falling into four cohorts (general population, patients with an existing clinical label of heart failure, patients prescribed diuretics, and patients deemed at high risk of heart failure). MAIN OUTCOME MEASURE: Sensitivity, specificity, positive and negative predictive values, likelihood ratios, and area under receiver operating characteristic curve for NT-proBNP assay in the diagnosis of heart failure. RESULTS: For NT-proBNP in the diagnosis of heart failure in the general population (population screen), a level of >36 pmol/l had a sensitivity of 100%, a specificity of 70%, a positive predictive value of 7%, a negative predictive value of 100%, and an area under the receiver operating characteristic curve of 0.92 (95% confidence interval 0.82 to 1.0). Similar negative predictive values were found for patients from the three other populations screened. CONCLUSIONS: This NT-proBNP assay seems to have value in the diagnosis of heart failure in the community. High negative predictive values indicate that the assay's chief use would be to rule out heart failure in patients with suspected heart failure with normal concentrations of NT-proBNP. Positive results may identify patients who need cardiac imaging.

Career pathways in research: support and management.

This article, the third in the series on career pathways, highlights support and management careers open to nurses working in the NHS and research and development, or people working for funding bodies or charitable organisations. These roles involve ensuring that the right infrastructure is in place to support research projects, and the correct decisions are made about which research projects should be supported and commissioned.

Career pathways in research: clinical research.

This article, the second in a series on career pathways, informs readers of the knowledge they require to conduct clinical therapeutic trials to recognised standards. Many nurses start their careers in research as clinical research nurses. The skills and knowledge they develop through conducting multi-centre studies gives them an excellent grounding in the discipline, organisation and management of research.

Career pathways in research: pharmaceutical.

The pharmaceutical pathway is the final article in this series on career pathways and highlights opportunities for nurses within associated industries. This pathway shows that nurses can use their nursing qualifications, combined with their knowledge, skills and expertise, to develop a career within another sphere of employment.

Career pathways in research: academic.

The academic pathway is the fourth in this series on career pathways and might be considered the most traditional career related to research. However, as is demonstrated in this series, research is every nurse's business and not a discipline to be conducted solely through academic institutions.

Patient attitudes to over-the-counter drugs and possible professional responses to self-medication.

BACKGROUND: There is a paucity of research about patients' attitudes towards their doctor's recommending over-the-counter (OTC) remedies or about how patients respond to the doctor's suggestion to try an OTC remedy. OBJECTIVES: The aim of this study was to ascertain the attitudes of patients to OTC drugs. METHODS: 505 consecutive patients from each of six participating practices filled in a questionnaire. RESULTS: A total of 2765 (91.3%) patients responded. The responses from 2624 patients were from adults and are presented here. Based on the number of valid responses to each question, 53.8% of these patients were exempt from prescription charges, 55.1% took regular prescribed medication and 24.6% stated that they used OTC remedies regularly. There were generally positive attitudes to doctors enquiring about prior OTC use as well as to doctors making OTC recommendations in the consultation. However, patients expressed fairly negative attitudes towards pharmacists making generic substitutions and were even more hostile to the idea that pharmacists should make therapeutic substitutions. CONCLUSION: In conclusion, GPs should consider asking their patients regularly about their use of OTC medicines and also consider recommending OTC use if this is cheaper than FP10s. However, the public at present do not appear to be prepared for interventions by the pharmacist.

Accuracy of routinely collected clinical data on acute medical admissions to one hospital.

Despite the rapid growth in routine computerized data collection within the National Health Service (NHS), and the increased use of such data for generating hospital statistics and doctor activity rates, few validation studies exist. During a study of 158 acute medical admissions, and examination of hospital data revealed numerous and systematic inaccuracies. If general practitioner (GP) performance statistics are to be reliably based on such sources, data validation, staff training, and protocols for data entry should form a routine part of NHS practice.

Analysis of primary care staff language about aggression at work using concordancing techniques to identify themes.

OBJECTIVE: We aimed to describe features of language used during interviews about the extent of aggression and violence at work and their effect on primary care staff. METHOD: Forty-four primary health care team members in the West Midlands were interviewed, and interviews were recorded on videotape. The language content of these interviews was analysed using Cobuild concordancing software. Outcome measures used were word frequency, collocation and mutual information (MI) scores for language use. RESULTS: A total of 17517 words spoken by interviewees were analysed. Violence in this sample was perceived as occurring principally in connection with unmet demands for such things as prescriptions and referrals. Only patients were perceived as violent; health care workers used other terms to describe their own feelings and responses. Sixty-eight specific incidents of violence were recounted, features perceived as salient being drink, youth and to a lesser extent mental illness. CONCLUSIONS: Concordancing software can be successfully used in the qualitative examination of videotaped interviews. In this study, the technique rapidly identified a number of perceived training needs among a variety of primary care staff.

A national survey to medical and dental schools to assess the level of undergraduate teaching and research about HIV/AIDS in the UK.

The views of heads of academic departments in UK medical and dental schools on the extent of their specialty's involvement in teaching undergraduates about HIV/AIDS and undertaking research in this area was ascertained by postal questionnaire. Three hundred and nineteen responses were received from medical schools (61.7%) and 58 responses from dental schools (53.2%). The greatest number of responses in one specialty was received from the Departments of General Practice, Paediatrics and Children's Dentistry. The amount of teaching varied widely, was dispersed throughout the curriculum within a wide range of broader subject areas and tended to be carried out by senior staff using didactic lecture format. Dental courses were more often assessed than medical courses. The small number of patients available was seen as a major problem. Involvement in research was appreciable. However, knowledge of student awareness campaigns was not widespread. We conclude that more specific teaching on HIV/AIDS is needed, particularly discussion about attitudes towards patients and ethical issues. HIV/AIDS counsellors should have an increased involvement in undergraduate teaching and teaching methods should provide opportunities for interactive discussion. Extensive research is being conducted in the UK. However, further work is needed to identify the perceived needs of students and the extent to which these are being met.

Reliability and feasibility of a near patient test for C-reactive protein in primary care.

BACKGROUND: The applications of new diagnostic technologies such as near patient tests are relevant to the further development and potential of primary care. Through their use, doctors in the community may increase the accuracy of their diagnoses and improve their ability to monitor disease. A reliable indicator of disease activity in various clinical conditions is C-reactive protein (CRP) and a near patient test for this is now available, although there is little information on its use outside hospitals. AIM: A study was set up to evaluate the feasibility of using a novel near patient test for CRP in primary care to validate the results against the laboratory "gold standard' for CRP (Beckman Array) and to compare results with the usual inflammation test used in general practice. METHOD: Prospective recording of CRP as a near patient test on an "intention to investigate' basis, with validation of results against the Beckman Array system for CRP and hospital laboratory erythrocyte sedimentation rate results, in six general medical practices in Birmingham. Main outcome measures were change in local laboratory usage, characteristics of patients chosen for testing, use of quality control, and comparison of readings with results from the same sample sent to an independent laboratory. RESULTS: Tests of CRP levels were rarely requested before the study was undertaken. During the 3-month study period, 181 near patient tests were carried out, 146 (81%) to establish a diagnosis and the remainder for disease monitoring. Out of the tests, 67% were performed by general practitioners, mostly during the consultation itself. Using a cut-off level of 10 mg I-1, the near patient test and the Beckman Array gave results which agreed in 84% of cases. The sensitivity and specificity of the near patient test results were 97 and 79%, respectively. The predictive value of a positive result was 59% and that of a negative result was 99%. Cohen's Kappa was 62% and the overall mean bias for results in the range of the test was 6.11 mg I-1 (SE = 3.07 mg I-1). Each test took 6 min on average to perform, including all preparations, blood letting, performing the test and averaging the time for quality control estimations. The cost per test averaged pounds 1.72, rising to pounds 4.17 including labour, capital costs, quality controls and consumables (general practitioner performing the assay at average frequency found in this study). CONCLUSIONS: Measurement of CRP is rarely used in primary care and awareness of its value could be raised. This near patient test proved feasible for use by general practitioners and practice nurses. Its reliability compared with a laboratory result was satisfactory overall, and excellent with adequate operator technique.

Effect of Helicobacter pylori eradication therapy on dyspeptic symptoms in primary care.

OBJECTIVE: The aim was to explore the effect of eradication therapy on dyspeptic symptoms in patients with known peptic ulcer disease (PUD). METHOD: A total of 164 known dyspeptics and 147 non-dyspeptic attenders at six UK general practices were recruited. The Helisal Rapid Blood test was performed in the practices and eradication therapy left to the preference of the general practitioner. Patients were followed prospectively by a Likert scaled symptom questionnaire and record review. The symptom questionnaire distinguished between patients known to have dyspepsia and those not. RESULTS: There was a statistically significant decrease in dyspeptic symptoms in patients with known PUD who received eradication therapy (n = 43, Z = -2.63, P = 0.009). CONCLUSIONS: Eradication of Helicobacter pylori in primary care can lead to a reduction in consumption of H2 receptor antagonists and hence cost savings. This study demonstrates that dyspeptic symptoms also decrease. The questionnaire could be used in further studies to evaluate the effect of management on dyspeptic symptoms in the primary care setting.

A randomized controlled trial of electromagnetic therapy in the primary care management of venous leg ulceration.

OBJECTIVE: The aim was to establish the potential efficacy, tolerability and side-effect profile of electromagnetic therapy as an adjunct to conventional dressings in the treatment of venous leg ulcers. METHOD: A prospective, randomized, double blind controlled clinical trial was carried out in a dedicated leg ulcer clinic based in one urban general practice. Nineteen patients with leg ulcers of confirmed venous aetiology were assessed. The main outcome measures were rate and scale of venous leg ulcer healing, changes in patient-reported pain levels, quality of life, degree of mobility, side effect profile and acceptability to patients and staff. RESULTS: Sixty-eight per cent of patients attending this dedicated clinic achieved improvements in the size of their ulcer (4, 21%, healed fully) and in reduced pain levels (P < 0.05) during the trial, despite the chronicity of ulcer histories. Patients treated with electromagnetic therapy at 800 Hz were found at day 50 to have significantly greater healing (P < 0.05) and pain control (P < 0.05) than placebo therapy or treatment with 600 Hz. All patients reported improved mobility at the end of the study. The electromagnetic therapy was well tolerated by patients, with no differences between groups in reporting adverse events, and proved acceptable to staff. CONCLUSIONS: Despite the small numbers in this pilot study, electromagnetic therapy provided significant gains in the healing of venous leg ulcers and reduction in pain.

A prospective controlled trial of computerized decision support for lipid management in primary care.

OBJECTIVES: This study aimed to assess the uptake and effect in primary care of a computerized decision support system (DSS) for the management of hyperlipidaemia. METHOD: A prospective controlled trial was conducted in 25 practices covering a population of 150,000 in the city of Birmingham. The Primed system, a specialist developed, rule based DSS for general practice, was introduced prospectively after a 3-month baseline data collection. The main outcome measures were nine months' data on prescribing of lipid lowering agents; use of laboratory tests; and referrals to secondary care for the investigation of hyperlipidaemia. RESULTS: System use was lower than expected. A shift was observed towards requests for appropriate follow-up of previously abnormal lipid results and a greater emphasis on full lipid profiles, in line with the DSS guidelines. Referrals showed a 55% decrease on those expected (NS). The prescribing evaluation revealed a large variation between practices, but no significant alteration following system use. Views of users favoured decision support as a concept, but criticised technical problems with the system. CONCLUSIONS: Greater integration of DSS software and practice based data handling systems is needed. The mode of data capture, and hence both the content and form of knowledge representation, in DSS must take greater account of the primary care consultation process if such systems are to be of use to practitioners.