Determining the need for ethical review: a three-stage Delphi study.

AIMS: The aims of the study were to explore expert opinion on the distinction between "research" and "audit", and to determine the need for review by a National Health Service (NHS) Research Ethics Committee (REC). BACKGROUND: Under current guidelines only "research" projects within the NHS require REC approval. Concerns have been expressed over difficulties in distinguishing between research and other types of project, and no existing guidelines appear to have been validated. The implications of this confusion include unnecessary REC applications, and crucially, the potential for ethically unsound projects to escape review. METHODS: A three-stage Delphi method was chosen to explore expert opinion and develop consensus. Stage 1 comprised ten semi-structured interviews gathering opinion on distinguishing between types of project and how to determine need for ethical review. Stages 2 and 3 were questionnaires, asking 24 "experts" to rate levels of ethical concern and types of project for a series of questions. Anonymised responses from stage 2 were fed back in stage 3. The final responses were analysed for consensus. RESULTS: Of 46 questions, consensus was achieved for 14 (30.4%) for level of ethical concern and for 15 (32.6%) for type of project. CONCLUSIONS: Several ideas proved discriminatory for classifying the type of project and assessing level of ethical concern, and they can be used to develop an algorithm to determine need for ethical review. There was little relationship between assessment of the level of ethical concern and classification of the project. There was inconsistency in defining and classifying studies as something other than "research" or "audit".

Evidence-based postoperative pain management in nursing: is a randomized-controlled trial the most appropriate design?

There is an increasing drive to make nursing care evidence-based. High quality evidence from systematic reviews relevant to postoperative pain relief exists, yet pain after surgery remains poorly controlled for many patients. This study aimed to assess whether implementing evidence-based pain management improved postoperative pain outcomes. Pain on a 0-10 scale was the primary outcome and analgesic consumption a secondary outcome. A baseline audit was undertaken on four surgical wards to establish whether there was a need for the study. A randomized-controlled trial was then designed to assess the effects of implementing an evidence-based approach to postoperative pain management. The four wards were randomized to receive the intervention or act as a control. Outcomes were assessed 3 months after the intervention on both intervention and control wards. The intervention (implementation of an oral analgesic algorithm derived from systematic reviews) was then implemented on the control wards and outcomes reassessed after 3 months on the control wards. The intervention was designed using an evidence-based approach to effective implementation. Four interactive sessions covered: (1) detailed feedback of baseline data and discussion (utilizing audit and feedback), (2) why systematic reviews, analgesic league tables and choice of drugs to develop an analgesic algorithm (see Figure 1), (3) principles of evidence based health care (EBHC), including critical appraisal and (4) facilitation and change workshop. The findings revealed no significant differences in pain level or drug use between the intervention and control wards. However, the control wards also changed during the control period. Possible explanations for this are discussed. When looking at changes compared with baseline, both intervention and control wards increased their use of algorithm drugs and reduced use of non-algorithm drugs during the study. No effects were found on pain in the intervention wards. Pain ratings at rest since surgery, on movement since surgery and worst pain on movement were significantly reduced compared with baseline in the control wards. Although there are many pressures to utilize a randomized-controlled trial study design in the culture of evidence-based health care, there will be times, especially when implementing complex changes in practice that other types of design should be considered.

Principles of statistical analysis in nursing and healthcare research.

In the first of three papers on statistical analysis, Nicola Crichton gives an overview of using statistical analysis in nursing and health care research.

Disseminating research evidence. A controlled trial in continence care.

The dissemination of research evidence from which clinical practice should be based poses many well-documented problems for nurses. This study set out to overcome some of the common barriers to dissemination by providing a research-based clinical handbook for continence care. The impact of the handbook on nurses' knowledge of both urinary and faecal incontinence was tested using an experimental and control group. The experimental group received the handbook while the control group did not. Both groups completed an assessment questionnaire at week 1, prior to the intervention in the experimental group, followed by a second assessment at week 7 after the intervention in the experimental group. Data were collected using semi-structured questionnaires. Statistically significant improvements in knowledge were found for those nurses who received a copy of the handbook, and nurses reported that they found the handbook useful and acceptable as a form of clinical updating. The dissemination of research findings is essential if evidence-based nursing is to become a reality, and this study clearly demonstrates one method by which this can be successfully achieved.

Models for diagnosing chest pain: is CART helpful?

The use of classification and regression tree (CART) methodology is explored for the diagnosis of patients complaining of anterior chest pain. The results are compared with those previously obtained using correspondence analysis and independent Bayes classification. The technique is shown to be of potential value for identifying important indicators and cutpoints for continuous variables, although the overall classification performance was rather disappointing. Suggestions are made for extensions to the methodology to make it more suitable for clinical practice.

Using research for practice: a UK experience of the BARRIERS Scale.

It is generally recognized that the majority of health care has been largely based upon opinion rather than research evidence of clinical effectiveness. Attempts to rectify this have been initiated by increasing emphasis on the dissemination of findings. For example, in the UK this had been supported via the Cochran Collaboration and the Centre for Dissemination and Reviews. Dissemination does not, however, guarantee implementation. The complex nature of research utilization has been studied and obstacles identified that can influence the uptake of research by practising nurses. Sandra Funk and colleagues developed the BARRIERS Scale using this research and literature on research utilization. The scale may be helpful for identifying and measuring the barriers to research utilization perceived by nurses working within the UK and has formed the basis of the present study. A convenience sample of 316 comprising a broad spectrum of nurses working in the UK provided the data. Comparison is made with North American nurses from the studies used in the scale's development. The results suggest there ware items which are consistently perceived as either strong or negligible barriers by both groups of nurses. Differences, however, did emerge between nurses from the UK and North America on several items. These included the confidence in evaluating research and the perception of the nurse's authority to change patient procedures. Psychometric evaluation was also done. These findings are presented and discussed.

School sex education: an experimental programme with educational and medical benefit.

OBJECTIVES: To develop and teach a school sex education programme that will lead to a decrease in sexual activity. DESIGN: A matched internal and external control experiment, comparing control populations which received their own sex education programmes with populations which received a novel sex education intervention that included medical and peer led teaching. SETTING: Comprehensive secondary schools; control and intervention populations within Devon, and distant controls from rural, semiurban, and urban areas of England excluding major conurbations. SUBJECTS: Schoolchildren were taught from age 12 to 16; three successive cohorts of students were evaluated in school year 11 (mean age 16.0). MAIN OUTCOME MEASURES: Questionnaire conducted under "examination conditions" and invigilated by the research team and other trained medical staff. RESULTS: In the intervention population, progressive increase in knowledge related to contraception, sexually transmitted diseases, and prevalence of sexual activity (chi 2 (trend) P < 0.001 for all three series); relative increase between intervention and control populations in knowledge, relative decrease in attitudes suggesting that sexual intercourse is of itself beneficial to teenagers and their relationships, relative decrease in sexual activity, and relative increase in approval of their "sex education" (relative risk > 1.00 with 95% confidence limits not including 1.00 for all series and for comparisons with both control populations); odds ratio (control v programme) for sexual activity of 1.45, controlling for sociodemographic variables. CONCLUSION: School sex education that includes specific targeted methods with the direct use of medical staff and peers can produce behavioural changes that lead to health benefit.

A method for determining rates of sexual activity in schoolchildren.

This report details a novel methodology for determining rates of sexual activity in schoolchildren. The method has been found to be acceptable to schools, parents and students, it receives a high level of co-operation, a low (1%) parental withdrawal, and a low number (3%) of inadequate responses. A marked advantage of this method is the absence of direct questioning about first intercourse which is often considered inappropriate within schools. Validation conducted by interview at the time of the questionnaire and one year postal questionnaire follow-up indicates that this method gives a good estimate of sexual activity for school populations.

Correspondence analysis as a screening method for indicants for clinical diagnosis.

In clinical diagnosis, a patient's symptoms are observed and the probabilities of various diseases are assessed. A widely used method of formalizing this approach is independent Bayes in which symptoms are assumed to be independent conditional on the disease category. Correspondence analysis provides a method for examining the dependence between symptoms and assists in the selection of a reduced set of symptoms for the application of the independent Bayes method. This approach is illustrated on two data sets concerned with patients attending Accident and Emergency departments with chest pain and acute abdominal pain, respectively.

An audit of doctor's management of patients with chest pain in the accident and emergency department.

In a series of 604 patients attending an accident and emergency department with chest pain, the decisions made by casualty officers about admission to the coronary care unit were compared with the retrospective opinions of experienced clinical assessors who knew the results of any subsequent investigations. Of the 119 patients whom the assessors judged should have been admitted to the coronary care unit, 14 (11.8 per cent) were judged to have been discharged in error. Of the 485 patients whom the assessors judged should not have been admitted to the coronary care unit, 32 (16 per cent) were judged to have been advised admission unnecessarily. Misinterpretation of the electrocardiographic results was apparently the reason for five of the 14 false negative errors and four of the 32 false positive errors. The median time that patients who were eventually admitted to the coronary care unit spent in the accident and emergency department was 78 min.

The role of chest radiography in patients presenting with anterior chest pain to the Accident & Emergency Department.

The chest radiological findings and outcomes of 120 consecutive patients attending the Accident & Emergency Department with anterior chest pain were recorded prospectively to investigate the value of routine chest radiography in their management. Twenty-one patients (17.5%) were excluded because of incomplete information. Thirty-seven radiological abnormalities were identified in 33 (33%) of the remaining 99 chest X-rays. Seventeen of the abnormalities identified in 14 (14%) of the chest X-rays were clinically significant. The casualty officer's interpretation of 70 (70%) of the chest X-rays was correct, but 36 errors were made interpreting the other 29 chest X-rays. Of these errors, 19 were false negative errors, resulting in the mismanagement of two patients and 17 false positive errors, resulting in the mismanagement of four patients. It appears that a routine chest X-ray provides little information of practical value in the management of patients with anterior chest pain attending an Accident & Emergency Department, unless the training of medical students and junior doctors in the interpretation of chest X-rays is improved.