Health technology assessment : HTA
-
Health Technol Assess · Jan 2001
Randomized Controlled Trial Multicenter Study Clinical TrialThe role of radiography in primary care patients with low back pain of at least 6 weeks duration: a randomised (unblinded) controlled trial.
To test the hypotheses that: (1) Lumbar spine radiography in primary care patients with low back pain is not associated with improved patient outcomes, including pain, disability, health status, sickness absence, reassurance, and patient satisfaction or belief in the value of radiography. (2) Lumbar spine radiography in primary care patients with low back pain is not associated with changes in patient management, including medication use, and the use of primary and secondary care services, physical therapies and complementary therapies. (3) Participants choosing their treatment group (i.e. radiography or no radiography) do not have better outcomes than those randomised to a treatment group. (4) Lumbar spine radiography is not cost-effective compared with usual care without lumbar spine radiography. ⋯ Lumbar spine radiography in primary care patients with low back pain of at least 6 weeks duration is not associated with improved functioning, severity of pain or overall health status, and is associated with an increase in GP workload. Participants receiving X-rays are more satisfied with their care, but are not less worried or more reassured about serious disease causing their low back pain. CONCLUSIONS - RECOMMENDATIONS FOR FURTHER RESEARCH: Further work is required to develop and test an educational package that educates patients and GPs about the utility of radiography and provides strategies for identifying and meeting the information needs of patients, and the needs of patients and GPs to be reassured about missing serious disease. Guidelines on the management of low back pain in primary care should be consistent about not recommending lumbar spine radiography in patients with low back pain in the absence of red flags for serious spinal pathology, even if the pain has persisted for at least 6 weeks.
-
Health Technol Assess · Jan 2001
Review Comparative StudyA rapid and systematic review of the clinical effectiveness and cost-effectiveness of topotecan for ovarian cancer.
Ovarian cancer is the most common gynaecological cancer with an annual incidence of 21.6 per 100,000 in England and Wales. Due to the often asymptomatic nature of the early stages of the disease, most cases are not detected until the advanced stages. Consequently, the prognosis after diagnosis is poor and the 5-year survival rate in the UK is only about 30%. Current recommendations suggest that first-line chemotherapy for ovarian cancer should involve paclitaxel and platinum (Pt)-based therapy (cisplatin/ carboplatin), however, most patients develop resistant or refractory disease and require second-line therapy. Patients may respond to re-challenge with Pt-agents if the treatment-free interval is > 6 months, but an alternative is often required. Topotecan is one of six drugs currently licensed in the UK for second-line therapy, and recent reviews suggest that it has modest efficacy in the treatment of advanced disease and performs favourably against paclitaxel. However, these reviews are based on a limited number of reports mainly consisting of non-randomised Phase I and II studies. ⋯ RECOMMENDATIONS FOR RESEARCH: Further good quality RCTs and CEAs are required comparing topotecan with other licensed and potentially useful (soon to be licensed) second-line treatments for ovarian cancer. At present, it is difficult to make any decisions about topotecan and other drugs for second-line therapy without good quality direct comparisons. In view of the ongoing studies identified, an update of the current review should be considered in approximately 18 months (Summer 2002) or possibly sooner if the recently commissioned National Institute for Clinical Excellence review of caelyx for ovarian cancer identifies additional data relevant to topotecan.
-
Health Technol Assess · Jan 2001
ReviewA rapid and systematic review of the clinical effectiveness and cost-effectiveness of orlistat in the management of obesity.
The prevalence of obesity in developed societies is increasing. Obesity is associated with an increased risk of co-morbidity, including cardiovascular disease and diabetes. Following the withdrawal of fenfluramine and dexfenfluramine, interest has focused on a novel anti-obesity drug orlistat. ⋯ To systematically assess the clinical effectiveness and cost-effectiveness of orlistat in the management of obesity. METHODS - SEARCH STRATEGY: Nineteen electronic databases were searched from inception to June 2000. Additionally, Internet searches were carried out, bibliographies of retrieved articles were examined and submissions were received from the manufacturer of orlistat. METHODS - INCLUSION AND EXCLUSION CRITERIA: Randomised controlled trials (RCTs) evaluating the effectiveness of orlistat used for weight loss or maintenance of weight loss in overweight or obese patients were eligible for inclusion. Primary outcome measures were changes in body weight, fat content or fat distribution. Secondary outcomes were changes in obesity-related risk-factor profiles, such as lipid levels, indicators of glycaemic control and blood pressure. Studies recruiting people with eating disorders such as anorexia nervosa and bulimia nervosa were excluded. METHODS - PROCESS OF STUDY SELECTION: Assessment of titles and abstracts was performed independently by two reviewers. If either reviewer considered a reference to be relevant, the full paper was retrieved. Full papers were assessed against the review selection criteria by two independent reviewers, and disagreements were resolved through discussion. METHODS - DATA EXTRACTION: Data were extracted by one reviewer into structured summary tables and checked by a second reviewer. Any disagreements about data were resolved by discussion. METHODS - QUALITY ASSESSMENT: Each included trial was assessed against a comprehensive checklist for methodological quality. Quality assessment was performed independently by two reviewers with disagreements resolved by discussion. METHODS - METHODS OF ANALYSIS/SYNTHESIS: This report is a narrative summary, with results grouped according to study endpoint. Statistical pooling was undertaken in groups of trials that were considered to be sufficiently similar. METHODS - ESTIMATION OF QUALITY OF LIFE, COSTS AND COST-EFFECTIVENESS AND/OR COST PER QUALITY-ADJUSTED LIFE-YEAR: Relevant economic evaluations were identified from the search strategy described above. Assessment of methodological quality was undertaken using principles outlined in published guidelines. METHODS - COMPANY SUBMISSIONS: Data from company submissions were subject to the same selection and appraisal processes as other studies considered for inclusion in the review, except that only RCTs with a duration of at least 1 year were selected. RESULTS - RESULTS OF THE SEARCH STRATEGY: Fourteen RCTs (including three company submissions) and two economic evaluations (including one company submission) were included in the review. RESULTS - RESULTS OF THE QUALITY ASSESSMENT: Methodological quality of trials was moderate to good. The main problems were lack of detail on methods used to produce true randomisation, small sample sizes in some cases and failure to use intention-to-treat analysis. It is likely that maintenance of blinding was difficult due to adverse effects associated with the study medication. RESULTS - EVIDENCE OF CLINICAL EFFECTIVENESS AND COST-EFFECTIVENESS: Most of the trials showed greater weight loss and better weight maintenance with orlistat compared to placebo at all endpoints (statistically significant differences for both outcomes). Orlistat 120 mg three times daily was the optimum regimen in terms of weight loss. Most trials showed significant improvement in at least some lipid concentration parameters, and, in three RCTs, orlistat produced statistically significant reductions in blood pressure relative to placebo. In obese patients with type 2 diabetes, orlistat resulted in a significantly greater weight loss at 1 year compared with placebo, and some parameters of glycaemic control and lipid concentration also showed significantly greater improvements compared with placebo. The incidence of gastrointestinal adverse events was consistently higher in orlistat groups compared with placebo, and orlistat use was associated with lower serum levels of fat-soluble vitamins. The cost per quality-adjusted life-year for orlistat was 45,881 UK pounds. CONCLUSIONS - IMPLICATIONS FOR CLINICAL PRACTICE: Although many trials have demonstrated statistically significant differences between groups in terms of weight loss in favour of orlistat versus placebo, the differences may not always be of clinical significance. The clinical significance of between-group differences for secondary outcomes may also be debatable. Possible adverse effects should be taken into account when prescribing orlistat, particularly gastrointestinal effects. (ABSTRACT TRUNCATED)
-
Health Technol Assess · Jan 2001
ReviewSystematic reviews of wound care management: (5) beds; (6) compression; (7) laser therapy, therapeutic ultrasound, electrotherapy and electromagnetic therapy.
Chronic wounds such as leg ulcers, diabetic foot ulcers and pressure sores are common in both acute and community healthcare settings. The prevention and treatment of these wounds involves many strategies: pressure-relieving beds, mattresses and cushions are universally used as measures for the prevention and treatment of pressure sores; compression therapy in a variety of forms is widely used for venous leg ulcer prevention and treatment; and a whole range of therapies involving laser, ultrasound and electricity is also applied to chronic wounds. This report covers the final three reviews from a series of seven. ⋯ Randomised controlled trials (RCTs) which evaluated these interventions were eligible for inclusion in this review if they used objective measures of outcome such as wound incidence or healing rates. RESULTS - BEDS, MATTRESSES AND CUSHIONS FOR PRESSURE SORE PREVENTION AND TREATMENT: A total of 45 RCTs were identified, of which 40 compared different mattresses, mattress overlays and beds. Only two trials evaluated cushions, one evaluated the use of sheepskins, and two looked at turning beds/kinetic therapy. RESULTS - COMPRESSION FOR LEG ULCERS: A total of 24 trials reporting 26 comparisons were included (two of prevention and 24 of treatment strategies). RESULTS - LOW-LEVEL LASER THERAPY, THERAPEUTIC ULTRASOUND, ELECTROTHERAPY AND ELECTROMAGNETIC THERAPY: Four RCTs of laser (for venous leg ulcers), 10 of therapeutic ultrasound (for pressure sores and venous leg ulcers), 12 of electrotherapy (for ischaemic and diabetic ulcers, and chronic wounds generally) and five of electromagnetic therapy (for venous leg ulcers and pressure sores) were included. Studies were generally small, and of poor methodological quality. CONCLUSIONS (1) Foam alternatives to the standard hospital foam mattress can reduce the incidence of pressure sores in people at risk, as can pressure-relieving overlays on the operating table. One study suggests that air-fluidised therapy may increase pressure sore healing rates. (2) Compression is more effective in healing venous leg ulcers than is no compression, and multi-layered high compression is more effective than single-layer compression. High-compression hosiery was more effective than moderate compression in preventing ulcer recurrence. (3) There is generally insufficient reliable evidence to draw conclusions about the contribution of laser therapy, therapeutic ultrasound, electrotherapy and electromagnetic therapy to chronic wound healing.