Systematic review of head cooling in adults after traumatic brain injury and stroke.

BACKGROUND: Brain injuries resulting from trauma and stroke are common and costly. Cooling therapy may reduce damage and potentially improve outcome. Head cooling targets the site of injury and may have fewer side effects than systemic cooling, but there has been no systematic review and the evidence base is unclear. OBJECTIVE: To assess the effect of non-invasive head cooling after traumatic brain injury (TBI) and stroke on intracranial and/or core body temperature, functional outcome and mortality, determine adverse effects and evaluate cost-effectiveness. REVIEW METHODS: Search strategy Major international databases [including MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, Web of Science, the British Library's Electronic Table of Contents (Zetoc)], The Cochrane Library, trial registers, country-specific databases (including China, Japan), Google Scholar, hypothermia conference reports and reference lists of papers were searched with no publication or language restrictions. The searches were conducted from March 2010 to April 2011, with no back date restriction. Selection criteria For formal analysis of effect of head cooling on functional outcome and mortality: randomised controlled trials (RCTs) of non-invasive head cooling in TBI or stroke in adults (aged ≥ 18 years). RCT prespecified in protocol to include adequate randomisation and blinded outcome assessment. For assessment of effect on temperature and adverse effects of cooling methods/devices: studies of any type in TBI, stroke, cardiac arrest and neonatal hypoxic-ischaemic encephalopathy (adverse effects only). Data collection and analysis A study assessment and data collection form was developed and piloted. Data on functional outcome, mortality, temperature change and adverse effects of devices were sought and extracted. Two authors independently assessed RCTs for quality using the Cochrane Renal Group checklist. RESULTS: Out of 46 head-cooling studies in TBI and stroke, there were no RCTs of suitable quality for formal outcome analysis. Twelve studies had useable data on intracranial and core body temperature. These included 99 patients who were cooled after TBI or stroke and 198 patients cooled after cardiac arrest. The data were too heterogeneous for a single summary measure of effect (many studies had no measure of spread) and are therefore presented descriptively. The most effective techniques for which there were adequate data (nasal coolant and liquid cooling helmets) could reduce intracranial temperature by ≥ 1 °C in 1 hour. The main device-related adverse effects were localised skin problems, which were generally mild and self-limiting. There were no suitable data for economic modelling, but an exploratory model of possible treatment effects and cost-effectiveness of head cooling in TBI was created using local patient data. LIMITATIONS: We conducted extensive and sensitive searches but found no good-quality RCTs of the effect of head cooling on functional outcome that met the review inclusion criteria. Most trials were small and/or of low methodological quality. However, if the trial reports did not reflect the true quality of the research, there may be some excluded trials that should have been included. Temperature data were often poorly reported which made it difficult to assess the effect of head cooling on temperature. CONCLUSIONS: Whether head cooling improves functional outcome or has benefits and fewer side effects compared with systemic cooling or no cooling could not be established. Some methods of head cooling can reduce intracranial temperature, which is an important first step in determining effectiveness, but there is insufficient evidence to recommend its use outside of research trials. The principal recommendations for research are that active cooling devices show the most promise for further investigation and more robust proof of concept of intracranial and core body temperature reduction with head cooling is required, clearly showing whether temperature has changed and by how much. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Randomised comparison of uterine artery embolisation (UAE) with surgical treatment in patients with symptomatic uterine fibroids (REST trial): 5-year results.

OBJECTIVE: To compare the long-term results of uterine artery embolisation (UAE) with surgery for women with symptomatic uterine fibroids. DESIGN: Pragmatic, open, multicentre, randomised trial. SETTING: Twenty-seven participating UK secondary care centres. SAMPLE: Women aged ≥18 years with symptomatic fibroids who were considered to justify surgical treatment. METHODS: In total, 157 women were randomised (in a 2:1 ratio): 106 to UAE and 51 to surgery (hysterectomy 42; myomectomy nine). MAIN OUTCOME MEASURES: Quality of life at 5 years, as assessed by the Short Form General Health Survey (SF-36). Secondary measures included complications, adverse events and the need for further intervention. RESULTS: There were no significant differences between groups in any of the eight components of the SF-36 scores at 5 years (minimum P = 0.45). Symptom score reduction and patient satisfaction with either treatment was very high, with no group difference. Rates of adverse events were similar in both groups (19% embolization and 25% surgery; P = 0.40). The 5-year intervention rate for treatment failure or complications was 32% (UAE arm) and 4% (surgery arm), respectively. The initial cost benefit of UAE over surgery at 12 months was substantially reduced because of subsequent interventions, with treatments being cost neutral at 5 years. CONCLUSIONS: We have found that UAE is a satisfactory alternative to surgery for fibroids. The less invasive nature of UAE needs to be balanced against the need for re-intervention in almost a third of patients. The choice should lie with the informed patient.

Randomized clinical trial comparing self-expanding metallic stents with plastic endoprostheses in the palliation of oesophageal cancer.

BACKGROUND: There is little evidence of the clinical and cost effectiveness of self-expanding metallic stents in the palliation of oesophageal cancer. The aims of this randomized trial were to evaluate the immediate and medium-term clinical outcomes following palliative intubation, examine patient quality of life, and evaluate costs and benefits from the perspective of the health service. METHODS: Fifty patients with inoperable oesophageal cancer were randomly allocated a metallic stent (n = 25) or plastic endoprosthesis (n = 25). Patients were followed up monthly until death. RESULTS: There was no significant difference in procedure-related complications or mortality rate between the two groups. There was a trend towards significance in favour of metallic stents with respect to quality of life and survival (median survival 62 versus 107 days for plastic prosthesis and metallic stent respectively). The cost of the initial placement of metallic stents was significantly higher than that of plastic endoprostheses ( pound 983 versus pound 296). After 4 weeks, cost differences were no longer significant. CONCLUSION: Metallic stents may contribute to improved survival and quality of life in patients with oesophageal cancer. Although initially more expensive, this cost difference does not last beyond 4 weeks. A larger trial involving approximately 300 patients would be required to detect a quality of life benefit of the magnitude observed in this trial.

Service provision for people with schizophrenia. I. Clinical and economic perspective.

BACKGROUND: The aim of this study was to provide information on patients current service use which could inform future decisions on service planning and resource allocation. METHOD: Individuals with a diagnosis of schizophrenia, who had received in-patient care in the previous five years, were identified from the Lothian Case Register. Information was obtained from 193 subjects. Patients' service use over a six-month period was examined. The costs incurred in service provision were determined. RESULTS: Patients differed markedly in their use of services. This was not found to be related to their mental state. Average care costs were high. In-patient care accounted for most of the overall expenditure. CONCLUSIONS: There is considerable variation in the services used by patients with schizophrenia and in the costs incurred in service provision. When planning services it is therefore important that detailed information on the patient population is available if resources are to be allocated cost-effectively.

Case mix adjustment in comparative audit.

There is increasing pressure to measure and publicize the quality of health care, with, for example, hospital 'league tables' appearing regularly in the lay press. Equally, there is increasing recognition that such simplistic presentations of data can be seriously misleading, as differences in case mix mean that they do not compare like with like. We discuss what is required of a statistical model if it si to be used to make comparisons of clinical performance which are adjusted for case mix. Outcome measures must be well defined and relevant, and the risk factors used in the model must reflect the patients' potential prognosis rather than aspects of his or her clinical care. In addition, the calibration of the statistical model is crucial. We review a number of established clinical scoring systems and demonstrate that they fail to meet all of the required criteria. Of particular concern is the fact that these scoring systems are susceptible to biases which could actually mask differences in performance. We highlight areas where further research is required, with the aim of stimulating progress in this field.

Presentation of comparative audit data.

The Royal College of Surgeons of England organizes a voluntary comparative audit service for its general surgical fellows. To date, the information from the audit has been presented purely descriptively, which does not take account of statistical variability and the effects of differences in case mix between the participants. A new approach to the presentation of these data, based on statistical modelling of the effects of case mix, is presented. The approach is illustrated in an application based on data relating to 136203 admissions reported by 110 surgeons. The result of adjusting for case mix is a substantial change in the relative performance of the participating surgeons, which demonstrates the folly of attempting to compare surgical performance on the basis of a measure as crude as the unadjusted mortality rate. Further development of the statistical modelling is required, but this new statistical approach appears to enhance greatly the credibility of the audit data, by quantifying its strengths and limitations.

Cross-sectional assessment of caries and periodontitis risk within the same subject.

Dental caries and chronic periodontitis may be synergistically associated, negatively associated, or completely independent. The present report examines this relationship by comparing the susceptibility to chronic periodontitis and caries within the same individual. From an 800-patient sample, a periodontitis risk score was derived by radiographic assessment of bone loss in quarters of optimum bone height and obtaining for each subject a mean score based on all measurable surfaces. Similarly the caries risk was determined radiographically from the total decayed and filled teeth (DFT), as a percentage of the total teeth measured. The Mantel-Haenszel technique was used for analysis of the relationship between periodontitis and caries and data was stratified on four categories of age, sex, and numbers of teeth present. This analysis revealed no systematic patterns, indicating that the risks of caries and periodontal diseases are unrelated (chi 2 = 0.00; 1 df; P greater than 0.50). In addition, a regression analysis, which was controlled for sex and age, indicated a marked lack of association between caries and periodontitis (P = 0.94). Thus, although these common diseases share putative etiologic factors such as oral hygiene practices and dental attendance pattern, the major risk factors are probably quite different.