VenUS II: a randomised controlled trial of larval therapy in the management of leg ulcers.

OBJECTIVES: To compare the clinical effectiveness and cost-effectiveness of larval therapy with a standard debridement technique (hydrogel). DESIGN: A pragmatic, three-arm, randomised controlled trial with an economic evaluation. SETTING: Community nursing services, community leg ulcer clinics and hospital outpatient leg ulcer clinics. A range of urban and rural settings. PARTICIPANTS: Patients with venous or mixed venous/arterial ulcers (minimum ankle brachial pressure index of 0.6) where a minimum of 25% of ulcer area was covered by slough and/or necrotic material. INTERVENTIONS: Loose larval therapy and bagged larval therapy compared with hydrogel. MAIN OUTCOME MEASURES: The primary end point was complete healing of the largest eligible ulcer. The primary outcome was time to complete healing of the reference ulcer. Secondary outcomes were: time to debridement, cost of treatments, health-related quality of life (including ulcer-related pain), bacterial load, presence of methicillin-resistant Staphylococcus aureus and staff and patient attitudes to and beliefs about larval therapy. RESULTS: Between July 2004 and May 2007 the trial recruited 267 people aged 20-94 years at trial entry. There were more female (n = 158) than male (n = 109) participants and most ulcers were classified by the nurse as having an area greater than 5 cm(2). The time to healing for the three treatment arms was compared using the log rank test. The difference in time to healing in the three treatments was not statistically significant at the 5% level. Adjustment was then made for stratification and prespecified prognostic factors (centre, baseline ulcer area, ulcer duration and type of ulcer) using a Cox proportional hazards model. No difference was found in healing rates between the loose and bagged larvae groups. Results for larvae (loose and bagged pooled) compared with hydrogel showed no evidence of a difference in time to healing. When the same analytical steps were used to investigate time to debridement, larvae-treated ulcers debrided significantly more rapidly than hydrogel-treated ulcers; however, the difference in time to debridement between loose and bagged larvae was not significant. The adjusted analysis reported the hazard of debriding at any time for those in loose and bagged larvae groups as approximately twice that of the hydrogel group. No differences in health-related quality of life or bacteriology were observed between trial arms. Larval therapy was associated with significantly more ulcer-related pain than hydrogel. Our base-case economic evaluation showed large decision uncertainty associated with the cost-effectiveness of larval therapy compared with hydrogel, suggesting that larval therapy and hydrogel therapy have similar costs and effects in the treatment of sloughy and/or necrotic leg ulcers. CONCLUSIONS: Larval therapy significantly reduced the time to debridement of sloughy and/or necrotic, chronic venous and mixed venous/arterial leg ulcers, compared with hydrogel; however, larval therapy did not significantly increase the rate of healing of the ulcers. It was impossible to distinguish between larval therapy and hydrogel in terms of cost-effectiveness. Future research should investigate the association of debridement and healing and the value of debridement as a clinical outcome for patients and clinicians. To inform decision-makers' selection of debriding agents where debridement is the treatment goal, decision analytic modelling of all alternative debridement treatments is required. TRIAL REGISTRATION: Current Controlled Trials ISRCTN55114812.

Research information in nurses' clinical decision-making: what is useful?

AIM: To examine those sources of information which nurses find useful for reducing the uncertainty associated with their clinical decisions. BACKGROUND: Nursing research has concentrated almost exclusively on the concept of research implementation. Few, if any, papers examine the use of research knowledge in the context of clinical decision-making. There is a need to establish how useful nurses perceive information sources are, for reducing the uncertainties they face when making clinical decisions. DESIGN: Cross-case analysis involving qualitative interviews, observation, documentary audit and Q methodological modelling of shared subjectivities amongst nurses. The case sites were three large acute hospitals in the north of England, United Kingdom. One hundred and eight nurses were interviewed, 61 of whom were also observed for a total of 180 hours and 122 nurses were involved in the Q modelling exercise. RESULTS: Text-based and electronic sources of research-based information yielded only small amounts of utility for practising clinicians. Despite isolating four significantly different perspectives on what sources were useful for clinical decision-making, it was human sources of information for practice that were overwhelmingly perceived as the most useful in reducing the clinical uncertainties of nurse decision-makers. CONCLUSIONS: It is not research knowledge per se that carries little weight in the clinical decisions of nurses, but rather the medium through which it is delivered. Specifically, text-based and electronic resources are not viewed as useful by nurses engaged in making decisions in real time, in real practice, but those individuals who represent a trusted and clinically credible source are. More research needs to be carried out on the qualities of people regarded as clinically important information agents (specifically, those in clinical nurse specialist and associated roles) whose messages for practice appear so useful for clinicians.

The accessibility of research-based knowledge for nurses in United Kingdom acute care settings.

BACKGROUND: The successful dissemination of the results of the National Health Service (NHS) research and development strategy and the development of evidence based approaches to health care rely on clinicians having access to the best available evidence; evidence fit for the purpose of reducing the uncertainties associated with clinical decisions. AIM: To reveal the accessibility of those sources of information actually used by nurses, as well as those which they say they use. DESIGN: Mixed method case site, using interview, observational, Q sort and documentary audit data in medical, surgical and coronary care units (CCUs) in three acute hospitals. RESULTS: Three perspectives on accessibility were identified: (a) the humanist--in which human sources of information were the most accessible; (b) local information for local needs--in which locally produced resources were seen as the most accessible and (c) moving towards technology--in which information technology begins to be seen as accessible. Nurses' experience in a clinical specialty is positively associated with a perception that human sources such as clinical nurse specialists, link nurses, doctors and experienced clinical colleagues are more accessible than text based sources. Clinical specialization is associated with different approaches to accessing research knowledge. Coronary care unit nurses were more likely to perceive local guidelines, protocols and on-line databases as more accessible than their counterparts in general medical and surgical wards. Only a third of text-based resources available to nurses on the wards had any explicit research base. These, and the remainder were out of date (mean age of textbooks 11 years), and authorship hard to ascertain. CONCLUSION: A strategy to increase the use of research evidence by nurses should harness the influence of clinical nurse specialists, link nurses and those engaged in practice development. These roles could act as 'conduits' through which research-based messages for practice, and information for clinical decision making, could flow. This role should be explored and enhanced.

Developing critical appraisal skills.

Critical appraisal is used to evaluate research and determine whether it should be incorporated into the reader's area of practice. Checklists are used in critical appraisal to provide a useful framework for the systematic analysis of research studies. Critical appraisal skills can be acquired in a number of ways, and can even be self-taught.

The impact of nursing grade on the quality and outcome of nursing care.

The large industry which has grown up around the estimation of nursing requirements for a ward or for a hospital takes little account of variations in nursing skill; meanwhile nursing researchers tend to concentrate on the appropriate organisation of the nursing process to deliver best quality care. This paper, drawing on a Department of Health funded study, analyses the relation between skill mix of a group of nurses and the quality of care provided. Detailed data was collected on 15 wards at 7 sites on both the quality and outcome of care delivered by nurses of different grades, which allowed for analysis at several levels from a specific nurse-patient interaction to the shift sessions. The analysis shows a strong grade effect at the lowest level which is 'diluted' at each succeeding level of aggregation; there is also a strong ward effect at each of the lower levels of aggregation. The conclusion is simple; you pay for quality care.

Assessing the outcomes of nursing care.

There are many dimensions to outcome measurement for patient care and this study focuses on one aspect of outcome, namely that which is most concerned with the immediate effects of nursing care. Traditionally, outcome studies have been almost exclusively concerned with measuring the clinical outcomes of care with very little attempt being made to assess the effect of the nurses' contributions to that care. One of this study's purposes has been to redress this imbalance. As part of a research project on skill mix and the effectiveness of nursing care, a number of patient-focused standards related to the outcome of nursing care were designed. These were tested, in a case study situation, on 15 wards at seven acute hospitals. Initial testing indicates that these outcome measures show promise as a valid and reliable evaluation instrument with the utility for easy application in the clinical setting. They are being presented as a possible way forward to assessing the outcomes of nursing care.

Skill mix in nursing: a selective review of the literature.

The issues surrounding skill mix are often highly contentious and, not surprisingly, various interest groups either welcome or reject attempts to examine the different combinations of staff, qualified and unqualified, experienced and inexperienced, in relation to costs, outcomes and quality of nursing care. Despite the strong passions aroused by the debate, other factors, most notably demographic changes and the possible shortage of nurses, new demands on health care services and the call for more cost-effective use of resources, have kept skill mix foremost on the policy agenda. The review covers manpower planning, an area where considerable efforts have been made to determine the number but rarely the mix of nurses required to provide the necessary care for patients. In addition, previous work on staff turnover, and the possibility of substituting less qualified for more qualified staff, are examined in relation to cost-containment, recruitment and demography, and the creation of a new single level of nurse. These factors, along with the introduction of health care assistants, will have an important influence on the future shape and structure of nursing and, of course, the composition of the skills available. While calling for further work on skill mix, the review provides a timely reminder that the issues are complex and often highly political.

The long-term effects of probucol on serum lipid levels.

Probucol, a serum cholesterol-lowering agent, was studied in a double-blind, placebo-controlled trial for one year in 118 hypercholesterolemic men. The mean decrease in the level of serum cholesterol in the probucol group (N = 88) from baseline for months 6 through 12 ranged from 16.2% to 20.9%. The mean decrease from baseline for the placebo-treated patients (N = 30) ranged from 5.2% to 12.7%. The difference between the groups was highly significant. At the end of this one-year trial, 61 of the probucol-treated patients continued receiving therapy in an open trial for up to seven years. After the second year of probucol treatment, the reduction in serum cholesterol levels ranged from 23.1% to 27.4% and was subsequently maintained. The present report shows that probucol is safe and effective for the long-term lowering of serum cholesterol levels in patients with primary hypercholesterolemia.

The influence of constitutional variables on orthogonal electrocardiograms of normal women.

Correlations between 276 orthogonal electrocardiographic measurements and constitutional variables were made in 450 normal women, aged 18 to 90 years. Advancing age led to decreases in amplitudes, left QRS axis shift, rightward and superior displacement of the ST segment, and anterior shift of the T wave. QZ was absent in 1% of normal women over age 40. In the oldest subjects, Ry amplitude was 71% and RZ amplitude was 80% of the respective values in the youngest group. Whereas QRS amplitude decreases with age leveled off at the sixth decade of life, they continued to old age for ST-T measurements. Men revealed steeper age trends than women. Blacks had larger QRS amplitudes and smaller Q/R ratios than whites. Stratification of electrocardiographic criteria according to age, sex, and race appears essential for routine interpretations and for epidemiological studies where new events, such as myocardial infarcts, need to be differentiated from normal age trends.

Diagnosis of acute myocardial infarction in patients undergoing open heart surgery: a comparison of serial myocardial imaging with cardiac enzymes, electrocardiography, and vectorcardiography.

In 44 consecutive patients undergoing elective open heart surgery (OHS), serial electrocardiograms (ECG), vectorcardiograms (VCG), serum CPK, cardiac isoenzymes (CPKMB), and myocardial images using Tc-99m pyrophosphate were obtained, before and after the operation, for the detection of acute myocardial infarction (AMI). Twenty-nine patients developed one or more positive tests postoperatively. Two patients had positive myocardial scintiscans; both had other evidence of infarction. Conversely, the appearance of CPKMB, or new ECG and VCG changes, occurred frequently without evidence of infarction, and were not associated with the development of a positive scintiscan. The results show that false-negative results are infrequent in patients imaged early after OHS, and that cardiac surgical procedures do not cause a high incidence of false-positive scintigrams. Consequently, radionuclide imaging for AMI offers an important adjunct for excluding acute infarction following open heart surgery.

Clinical application of a second generation electrocardiographic computer program.

An electrocardiographic computer program based on multivariate analysis of orthogonal leads (Frank) was applied to records transmitted daily by telephone from the Veterans Administration Hospital, West Roxbury, Mass., to the Veterans Administration Hospital, Washington, D. C. A Bayesian classification procedure was used to compute probabilities for all diagnostic categories that might be encountered in a given record. Computer results were compared with interpretations of conventional 12 lead tracings. Of 1,663 records transmitted, 1,192 were selected for the study because the clinical diagnosis in these cases could be firmly established on the basis of independent, nonelectrocardiographic information. Twenty-one percent of the records were obtained from patients without evidence of cardiac disease and 79 percent from patients with various cardiovascular illnesses. Diagnostic electrocardiographic classifications were considered correct when in agreement with documented clinical diagnoses. Of the total sample of 1,192 recordings, 86 percent were classified correctly by computer as compared with 68 percent by conventional 12 lead electrocardiographic analysis. Improvement in diagnostic recognition by computer was most striking in patients with hypertensive cardiovascular disease or chronic obstructive lung disease. The multivariate classification scheme functioned most efficiently when a problem-oriented approach to diagnosis was simulated. This was accomplished by a simple method of adjusting prior probabilities according to the diagnostic problem under consideration.