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Biomedical subjects

S O'Meara

Publications and source records attributed to S O'Meara.

At least 19 recordsLinked to original sources
PubMed2006

Patient acceptability of larval therapy for leg ulcer treatment: a randomised survey to inform the sample size calculation of a randomised trial.

BACKGROUND: A trial was commissioned to evaluate the effectiveness of larval therapy to debride and heal sloughy and necrotic venous leg ulcers. Larval therapy in the trial was to be delivered in either loose or bagged form. Researchers were concerned that resistance to larval therapy may threaten the feasibility of the trial. Additionally there was concern that the use of larval therapy may require a larger effect size in time to healing than originally proposed by the investigators. METHODS: To formally evaluate patient preferences a survey using two randomly allocated, nurse administered questionnaires was undertaken. Patients were randomised to receive one of the two following questionnaires (i) preferences between loose larvae and standard treatment (hydrogel) or (ii) patient preferences between bagged larvae and standard therapy (hydrogel). The study was undertaken in a Vascular Clinic, in an Outpatients Department of a large teaching hospital in the North of England. The sample consisted of 35 people aged 18 years and above with at least one leg ulcer of venous or mixed (venous and arterial) aetiology. RESULTS: Approximately 25% of participants would not consider the use of larval therapy as an acceptable treatment option for leg ulcers, regardless of the method of containment. For the patients that would consider the use of larval therapy, different preferences in healing times required to use the therapy were observed depending upon the method of containment. The median response of those participants questioned about bagged larvae found that they would be willing to use this therapy even if they were equally able to achieve healing with the use of hydrogel by 20 weeks. For those participants questioned about the use of loose larvae complete healing would have to have taken place over 17 weeks for them to choose larvae as their preferred option rather than hydrogel. This difference was not significant (p = 0.075). CONCLUSION: We found no evidence of widespread resistance to the utilisation of larval therapy from patients regardless of the method of larval therapy containment. These methods have the potential to inform sample size calculations where there are concerns of patient acceptability.

Aged↗
PubMed2006

Systematic review of antimicrobial treatments for diabetic foot ulcers.

BACKGROUND: Foot ulcers in diabetes are associated with increased mortality, illness and reduced quality of life. Ulcer infection impairs healing and antimicrobial interventions may cure infection, aid healing and reduce amputation rates. OBJECTIVES: To systematically review the evidence for antimicrobial interventions for foot ulcers in diabetes. METHODS: We searched 16 databases, 11 Internet sites, three books, conference proceedings, a journal and bibliographies in November 2002. We included randomized controlled trials (RCTs) or controlled clinical trials (CCTs). RESULTS: Twenty-three studies investigated the effectiveness or cost-effectiveness of antimicrobial agents: intravenous antibiotics (n = 8); oral antibiotics (n = 5); topical antimicrobials (n = 4); subcutaneous granulocyte-colony stimulating factor (G-CSF) (n = 4); Ayurvedic preparations (n = 1): and sugar vs. antibiotics vs. standard care (n = 1). The trials were small and too dissimilar to be pooled. There is no strong evidence for any particular antimicrobial agent for the prevention of amputation, resolution of infection, or ulcer healing. Pexiganan cream may be as effective as oral ofloxacin for resolution of infection. Ampicillin and sulbactam cost less than imipenem/cilastatin, G-CSF cost less than standard care and cadexomer iodine dressings may cost less than daily dressings. CONCLUSIONS: The evidence is too weak to recommend any particular antimicrobial agent. Large studies are needed of the effectiveness and cost-effectiveness of antimicrobial interventions.

Anti-Infective Agents↗
PubMed2006

Systematic review of methods to diagnose infection in foot ulcers in diabetes.

AIM: To undertake a systematic review of the diagnostic performance of clinical examination, sample acquisition and sample analysis in infected foot ulcers in diabetes. METHODS: Nineteen electronic databases plus other sources were searched. To be included, studies had to fulfil the following criteria: (i) compare a method of clinical assessment, sample collection or sample analysis with a reference standard; (ii) recruit diabetic individuals with foot ulcers; (ii) present 2 x 2 diagnostic data. Studies were critically appraised using a 12-item checklist. RESULTS: Three eligible studies were identified, one each on clinical examination, sample collection and sample analysis. For all three, study groups were heterogeneous with respect to wound type and a small proportion of participants had foot ulcers due to diabetes. No studies identified an optimum reference standard. Other methodological problems included non-blind interpretation of tests and the time lag between index and reference tests. Individual signs or symptoms of infection did not prove to be useful tests when assessed against punch biopsy as the reference standard. The wound swab did not perform well when assessed against tissue biopsy. Semiquantitative analysis of wound swab might be a useful alternative to quantitative analysis. The limitations of these findings and their impact on recommendations from relevant clinical guidelines are discussed. CONCLUSION: Given the importance of this topic, it is surprising that only three eligible studies were identified. It was not possible to describe the optimal methods of diagnosing infection in diabetic patients with foot ulceration from the evidence identified in this systematic review.

Biopsy↗
PubMed2006

A series of systematic reviews to inform a decision analysis for sampling and treating infected diabetic foot ulcers.

OBJECTIVES: To review systematically the evidence on the performance of diagnostic tests used to identify infection in diabetic foot ulcers (DFUs) and of interventions to treat infected DFUs. To use estimates derived from the systematic reviews to create a decision analytic model in order to identify the most effective method of diagnosing and treating infection and to identify areas of research that would lead to large reductions in clinical uncertainty. DATA SOURCES: Electronic databases covering period from inception of the database to November 2002. REVIEW METHODS: Selected studies were assessed against validated criteria and described in a narrative review. The structure of a decision analytic model was derived for two groups of patients in whom diagnostic tests were likely to be used. RESULTS: Three studies that investigated the performance of diagnostic tests for infection on populations including people with DFUs found that there was no evidence that single items on a clinical examination checklist were reliable in identifying infection in DFUs, that wound swabs perform poorly against wound biopsies, and that semi-quantitative analysis of wound swabs may be a useful alternative to quantitative analysis. However, few people with DFUs were included, so it was not possible to tell whether diagnostic performance differs for DFUs relative to wounds of other aetiologies. Twenty-three studies investigated the effectiveness (n = 23) or cost-effectiveness (n = 2) of antimicrobial agents for DFUs. Eight studied intravenous antibiotics, five oral antibiotics, four different topical agents such as dressings, four subcutaneous granulocyte colony stimulating factor (G-CSF), one evaluated oral and topical Ayurvedic preparations and one compared topical sugar versus antibiotics versus standard care. The majority of trials were underpowered and were too dissimilar to be pooled. There was no strong evidence for recommending any particular antimicrobial agent for the prevention of amputation, resolution of infection or ulcer healing. Topical pexiganan cream may be as effective as oral antibiotic treatment with ofloxacin for the resolution of local infection. Ampicillin and sulbactam were less costly than imipenem and cilastatin, a growth factor (G-CSF) was less costly than standard care and cadexomer iodine dressings may be less costly than daily dressings. A decision analytic model was derived for two groups of people, those for whom diagnostic testing would inform treatment--people with ulcers which do not appear infected but whose ulcer is not progressing despite optimal concurrent treatment--and those in whom a first course of antibiotics (prescribed empirically) have failed. There was insufficient information from the systematic reviews or interviews with experts to populate the model with transition probabilities for the sensitivity and specificity of diagnosis of infection in DFUs. Similarly, there was insufficient information on the probabilities of healing, amputation or death in the intervention studies for the two populations of interest. Therefore, we were unable to run the model to inform the most effective diagnostic and treatment strategy. CONCLUSIONS: The available evidence is too weak to be able to draw reliable implications for practice. This means that, in terms of diagnosis, infection in DFUs cannot be reliably identified using clinical assessment. This has implications for determining which patients need formal diagnostic testing for infection, on whether empirical treatment with antibiotics (before the results of diagnostic tests are available) leads to better outcomes, and on identifying the optimal methods of diagnostic testing. With respect to treatment, it is not known whether treatment with systemic or local antibiotics leads to better outcomes or whether any particular agent is more effective. Limited evidence suggests that both G-CSF and cadexomer iodine dressings may be less expensive than 'standard' care, that ampicillin/sulbactam may be less costly than imipenem/cilastatin, and that an unlicensed cream (pexiganan) may be as effective as oral ofloxacin. Further research is needed to ascertain the characteristics of infection in people with DFUs that influence healing and amputation outcomes, to determine whether detecting infection prior to treatment offers any benefit over empirical therapy, and to establish the most effective and cost-effective methods for detecting infection, as well as the relative effectiveness and cost-effectiveness of antimicrobial interventions for DFU infection.

Ampicillin↗
PubMed2005

Clinical effectiveness, tolerability and cost-effectiveness of newer drugs for epilepsy in adults: a systematic review and economic evaluation.

OBJECTIVES: To examine the clinical effectiveness, tolerability and cost-effectiveness of gabapentin (GBP), lamotrigine (LTG), levetiracetam (LEV), oxcarbazepine (OXC), tiagabine (TGB), topiramate (TPM) and vigabatrin (VGB) for epilepsy in adults. DATA SOURCES: Electronic databases. Internet resources. Pharmaceutical company submissions. REVIEW METHODS: Selected studies were screened and quality assessed. Separate analyses assessed clinical effectiveness, serious, rare and long-term adverse events and cost-effectiveness. An integrated economic analysis incorporating information on costs and effects of newer and older antiepileptic drugs (AEDs) was performed to give direct comparisons of long-term costs and benefits. RESULTS: A total of 212 studies were included in the review. All included systematic reviews were Cochrane reviews and of good quality. The quality of randomised controlled trials (RCTs) was variable. Assessment was hampered by poor reporting of methods of randomisation, allocation concealment and blinding. Few of the non-randomised studies were of good quality. The main weakness of the economic evaluations was inappropriate use of the cost-minimisation design. The included systematic reviews reported that newer AEDs were effective as adjunctive therapy compared to placebo. For newer versus older drugs, data were available for all three monotherapy AEDs, although data for OXC and TPM were limited. There was limited, poor-quality evidence of a significant improvement in cognitive function with LTG and OXC compared with older AEDs. However, there were no consistent statistically significant differences in other clinical outcomes, including proportion of seizure-free patients. No studies assessed effectiveness of AEDs in people with intellectual disabilities or in pregnant women. There was very little evidence to assess the effectiveness of AEDs in the elderly; no significant differences were found between LTG and carbamazepine monotherapy. Sixty-seven RCTs compared adjunctive therapy with placebo, older AEDs or other newer AEDs. For newer AEDs versus placebo, a trend was observed in favour of newer drugs, and there was evidence of statistically significant differences in proportion of responders favouring newer drugs. However, it was not possible to assess long-term effectiveness. Most trials were conducted in patients with partial seizures. For newer AEDs versus older drugs, there was no evidence to assess the effectiveness of LEV, LTG or OXC, and evidence for other newer drugs was limited to single studies. Trials only included patients with partial seizures and follow-up was relatively short. There was no evidence to assess effectiveness of adjunctive LEV, OXC or TPM versus other newer drugs, and there were no time to event or cognitive data. No studies assessed the effectiveness of adjunctive AEDs in the elderly or pregnant women. There was some evidence from one study (GBP versus LTG) that both drugs have some beneficial effect on behaviour in people with learning disabilities. Eighty RCTs reported the incidence of adverse events. There was no consistent or convincing evidence to draw any conclusions concerning relative safety and tolerability of newer AEDs compared with each other, older AEDs or placebo. The integrated economic analysis for monotherapy for newly diagnosed patients with partial seizures showed that older AEDs were more likely to be cost-effective, although there was considerable uncertainty in these results. The integrated analysis suggested that newer AEDs used as adjunctive therapy for refractory patients with partial seizures were more effective and more costly than continuing with existing treatment alone. Combination therapy, involving new AEDs, may be cost-effective at a threshold willingness to pay per quality-adjusted life year (QALY) greater than 20,000 pounds, depending on patients' previous treatment history. There was, again, considerable uncertainty in these results. There were few data available to determine effectiveness of treatments for patients with generalised seizures. LTG and VPA showed similar health benefits when used as monotherapy. VPA was less costly and was likely to be cost-effective. The analysis indicated that TPM might be cost-effective when used as an adjunctive therapy, with an estimated incremental cost-effectiveness ratio of 34,500 pounds compared with continuing current treatment alone. CONCLUSIONS: There was little good-quality evidence from clinical trials to support the use of newer monotherapy or adjunctive therapy AEDs over older drugs, or to support the use of one newer AED in preference to another. In general, data relating to clinical effectiveness, safety and tolerability failed to demonstrate consistent and statistically significant differences between the drugs. The exception was comparisons between newer adjunctive AEDs and placebo, where significant differences favoured newer AEDs. However, trials often had relatively short-term treatment durations and often failed to limit recruitment to either partial or generalised onset seizures, thus limiting the applicability of the data. Newer AEDs, used as monotherapy, may be cost-effective for the treatment of patients who have experienced adverse events with older AEDs, who have failed to respond to the older drugs, or where such drugs are contraindicated. The integrated economic analysis also suggested that newer AEDs used as adjunctive therapy may be cost-effective compared with the continuing current treatment alone given a QALY of about 20,000 pounds. There is a need for more direct comparisons of the different AEDs within clinical trials, considering different treatment sequences within both monotherapy and adjunctive therapy. Length of follow-up also needs to be considered. Trials are needed that recruit patients with either partial or generalised seizures; that investigate effectiveness and cost-effectiveness in patients with generalised onset seizures and that investigate effectiveness in specific populations of epilepsy patients, as well as studies evaluating cognitive outcomes to use more stringent testing protocols and to adopt a more consistent approach in assessing outcomes. Further research is also required to assess the quality of life within trials of epilepsy therapy using preference-based measures of outcomes that generate cost-effectiveness data. Future RCTs should use CONSORT guidelines; and observational data to provide information on the use of AEDs in actual practice, including details of treatment sequences and doses.

Adolescent↗
PubMed2004

A systematic review of the clinical effectiveness of orlistat used for the management of obesity.

The aim of this paper is to assess the clinical effectiveness of orlistat used for the management of obesity. Nineteen electronic databases were searched for randomized controlled trials evaluating the effectiveness of orlistat for weight loss or maintenance of weight loss in overweight or obese patients. Each included trial was assessed for methodological quality. Statistical pooling was performed when trials were considered to be sufficiently similar. Twenty-three trials were eligible for inclusion. Placebo-controlled trials recruiting patients with uncomplicated obesity reported statistically significant differences in favour of orlistat for weight loss and changes in obesity-related risk factors at all time points. Trials in obese patients with defined risk factors at baseline showed similar results, however, smaller effect sizes were observed in patients with type 2 diabetes. The effectiveness of orlistat relative to other anti-obesity drugs is currently unclear. When orlistat was added to simvastatin, this proved to be more effective for weight loss than either drug used individually. Orlistat use is associated with a higher incidence of gastrointestinal adverse events compared with placebo. In conclusion, orlistat is more effective than placebo in promoting weight loss, maintenance of weight loss, and improving cardiovascular risk factor profiles. Baseline parameters of patients seen in clinical practice should be taken into account when considering treatment.

Anti-Obesity Agents↗
PubMed2002

Homoeopathy.

Explore the source record for details and available documents.

Drug Prescriptions↗
PubMed2001

Interventions for preventing obesity in children.

BACKGROUND: The prevalence of obesity and overweight is increasing world-wide. Obesity in children impacts on their health in both the short and longer term. Obesity prevention strategies are poorly understood. OBJECTIVES: To assess the effectiveness of interventions designed to prevent obesity in childhood. SEARCH STRATEGY: Electronic databases were searched from 1985 to October 1999. SELECTION CRITERIA: Data from RCTs and non-randomised trials with concurrent control group were included. studies with follow up of one year minimum were selected, A priori, this was subsequently amended to include studies with minimum follow up of three months. The possible susceptibility of post hoc questions to bias is addressed. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study quality. MAIN RESULTS: Seven studies were included, three long-term and four short- term. The studies included were diverse in terms of study design and quality, target population, theoretical underpinning of intervention approach, and outcome measures. As such, it was not possible to combine study findings using statistical methods. REVIEWER'S CONCLUSIONS: The findings of the review suggest that currently there is limited quality data on the effectiveness of obesity prevention programs and as such no generalisable conclusions can be drawn. The need for well-designed studies which examine a range of interventions remains a priority.

Adolescent↗
PubMed2001

Interventions for preventing obesity in childhood. A systematic review.

BACKGROUND: The prevalence of obesity and overweight is increasing worldwide. Obesity in children impacts on their health in both short- and long-term. Obesity prevention strategies are poorly understood. OBJECTIVE: To assess the effectiveness of interventions designed to prevent obesity in childhood. SEARCH STRATEGY: Electronic databases were searched from January 1985 to October 1999. SELECTION CRITERIA: Data from randomized control trials and non-randomized trials with concurrent control group were included. A priori, studies with follow up of 1 year minimum were selected however, this was subsequently amended to include studies with a minimum follow up of three months. DATA COLLECTION & ANALYSIS: Two reviewers independently extracted data and assessed study quality. MAIN RESULTS: Seven studies were included, three long-term (> 1 years) and four short-term (> 3 months and < 1 years). The studies included were diverse in terms of study design and quality, target population, theoretical underpinning of intervention approach, and outcome measures. As such, it was not appropriate to combine study findings using statistical methods. CONCLUSIONS: Two of the long-term studies (one focused on dietary education and physical activity vs. control, and the other only on dietary education vs. control), resulted in a reduction in the prevalence on obesity, but the third, which focused on dietary education and physical activity, found no effect. Of the four short-term studies, three focused simply on physical activity/reduction of sedentary behavious vs. control. Two of these studies resulted in a reduction in the prevalence of obesity in intervention groups compared with control groups, and another study found a non-significant reduction. The fourth study focused on dietary education and physical activity, and did not find an effect on obesity, but did report a reduction in fat intake. Overall, the findings of the review suggest that currently there is limited quality data on the effectiveness of obesity prevention programmes and as such no generalizable conclusions can be drawn. The need for well-designed studies that examine a range of interventions remains a priority.

Child↗
PubMed2001

A rapid and systematic review of the clinical effectiveness and cost-effectiveness of debriding agents in treating surgical wounds healing by secondary intention.

BACKGROUND: Most surgically sutured wounds heal without any complication. However, in some cases wound healing can be delayed due to the presence of infection or wound breakdown. This can result in the wounds becoming cavity wounds and thus necessitate healing by secondary intention. Other surgical wounds that are not sutured but left to heal by secondary intention include abscess cavities such as perianal abscesses or breast abscesses. Surgical wounds healing by secondary intention are thought to heal more slowly than wounds healing by primary intention, especially if infection is present or healing is compromised by factors such as decreased blood supply, poor nutritional status or a general suppression of the immune response. Such wounds may contain dead tissue and have a moderate or high level of exudate. Debridement involves the removal of devitalised, necrotic tissue or fibrin from a wound. There are many different methods that can be used to debride a wound, which are broadly classified as surgical/sharp, biosurgical, mechanical, chemical, enzymatic and autolytic. Although it is generally agreed that the management of surgical wounds which contain devitalised tissue and are healing by secondary intention requires debridement, it is not always clear as to what is the best method or agent to use. There is currently a large selection of products with debriding properties available on the market, which vary considerably in cost. It is important that the choice of both debriding method and product is based on the best scientific evidence available, taking into account both cost and effectiveness data. OBJECTIVES: The review had two main objectives: (1) To determine the clinical effectiveness and cost-effectiveness of debriding agents in treating surgical wounds healing by secondary intention. (2) To evaluate the clinical effectiveness and cost-effectiveness of treating patients with surgical wounds healing by secondary intention at specialised wound care clinics as compared to conventional care. The review incorporated all debriding methods and any agent that is considered to have a debriding property. METHODS The following databases were searched using strategies designed specifically for each database: MEDLINE, EMBASE, CINAHL, HMIC (Health Management Information Consortium), CCTR via the Cochrane Library, the National Research Register (NRR), the NHS Economic Evaluation Database (NHS EED), and the Health Economic Evaluations Database (HEED). Additional references were identified through reviewing manufacturer and sponsor submissions made to NICE, the bibliographies of retrieved articles, and conferences proceedings on the Internet. Only randomised controlled trials (RCTs) or non-randomised controlled trials with concurrent controls and full economic evaluations were considered for inclusion. Only studies that evaluated some sort of debriding method or a specialised wound care clinic (a nurse with specialist training in wound care; care being provided by a multidisciplinary team; a fast-track referral system to other professions (e.g. dermatologist); or access to the latest health technology) were included in the review. Studies had to include participants with surgical wounds healing by secondary intention (e.g. cavity wounds, the consequences of wound dehiscence and abscesses) and report an objective measure of wound healing. Data were extracted by one reviewer and checked by a second. Quality assessment was conducted independently by two reviewers. Disagreements were resolved by consensus and, when necessary, by recourse to a third reviewer. The primary outcomes of interest were wound healing and cost. Results of data extraction and quality assessment were presented in structured tables and also as a narrative summary. In addition, where feasible, the results of individual studies were presented as forest plots. Studies were grouped according to the type of wound, debriding method and outcome measure used. RESULTS - CLINICAL EFFECTIVENESS: Seventeen trials met the inclusion criteria, all of which used the autolytic method of debridement. No studies were found that investigated sharp/surgical, biosurgical, mechanical, chemical or enzymatic debridement in the treatment of surgical wounds healing by secondary intention. No studies were found which investigated specialised wound care clinics that included the provision of care within a clinical setting (based in either primary or secondary care). The type of surgical wounds investigated by studies included in the review were those that had broken down postoperatively, perineal wounds resulting from proctolectomy or rectal excision, and those left open after pilonidal sinus excision or abscess incision, or wounds following a laparotomy. Four additional studies investigated treatment of postoperative wounds from toenail avulsions. (ABSTRACT TRUNCATED)

Clinical Trials as Topic↗
PubMed2001

A rapid and systematic review of the clinical effectiveness and cost-effectiveness of orlistat in the management of obesity.

BACKGROUND: 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. OBJECTIVE: 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)

Anti-Obesity Agents↗
PubMed2000

The effectiveness and cost-effectiveness of prophylactic removal of wisdom teeth.

BACKGROUND: Removal of wisdom teeth is one of the most common surgical procedures performed in the UK. Little controversy surrounds the removal of impacted third molars when they are associated with pathological changes such as infection, non-restorable carious lesions, cysts, tumours, and destruction of adjacent teeth and bone. However, the justification for prophylactic removal of impacted third molars is less certain and has been debated for many years. OBJECTIVES: To provide a summary of existing evidence on prophylactic removal of impacted wisdom teeth, in terms of the incidence of surgical complications associated with prophylactic removal, and the morbidity associated with retention. METHODS: A systematic review of the research literature was undertaken. METHODS - DATA SOURCES: An existing review formed the basis of this report, and additional literature searches were undertaken, including searches of electronic databases (MEDLINE, 1984-99; EMBASE, 1984-99; Science Citation Index, Cochrane Controlled Trials Register, National Research Register; Database of Abstracts of Reviews of Effectiveness), paper sources (including Clinical Evidence), and web-based resources. Relevant organisations and professional bodies were contacted for further information. METHODS - STUDY SELECTION: Studies were selected for inclusion if they met the following criteria: (1) design - randomised controlled trials (RCTs), literature reviews, or decision analyses; (2) participants - people with unerupted or impacted third molars, or those undergoing surgical removal of third molars either as prophylaxis or due to associated pathological changes; (3) reported outcomes - either the pathological changes associated with retention of third molars, or post-operative complications following extraction. There were no language restrictions on study selection. METHODS - DATA EXTRACTION AND SYNTHESIS: Data from included studies were extracted into structured tables and individual study validity was assessed against methodological checklists. Data were summarised descriptively. Decisions relating to study selection, data extraction and validity assessment were made by two independent reviewers, and disagreements were resolved by discussion. For non-English papers, translators were recruited to assist with study selection and data extraction. RESULTS: Forty studies were included in the review: two RCTs, 34 literature reviews, and four decision analysis studies. One RCT in the UK focused on the effects of retained third molars on incisor crowding (predominantly a cosmetic problem) in patients who had previously undergone orthodontic treatment. The results of this trial suggested that the removal of third molars to prevent late incisor crowding cannot be justified. Another on-going RCT in Denmark compares the effects and costs of prophylactic removal of third molars with removal according to morbidity. So far, this trial has recruited 200 participants, and preliminary results indicate that watchful waiting may be a promising strategy. However, more data and longer follow-up of patients are needed to conclude which treatment strategy is the most cost-effective. It is also known that a trial is on-going in the USA but no results are available so far. The methodological quality of the literature reviews was generally poor, and none of the reviews was systematic. Conclusions from nine reviews on anterior crowding suggested that there was only a weak association between retention of third molars and crowding. Six out of 21 reviews with a more general scope also concluded that the prophylactic removal of third molars was unjustified. Twelve general reviews did not conclude with a clear message about the management of third molars. Three reviews suggested that prophylactic removal of third molars is appropriate, but these reviews were of poorer methodological quality than the majority of other reviews. Three out of four papers focusing on surgical management expressed

Cost-Benefit Analysis↗
PubMed2000

Systematic reviews of wound care management: (3) antimicrobial agents for chronic wounds; (4) diabetic foot ulceration.

BACKGROUND: Chronic wounds, including pressure sores, leg ulcers, diabetic foot ulcers and other kinds of wounds, healing by secondary intention are common in both acute and community settings. The prevention and treatment of chronic wounds includes many strategies, including the use of various wound dressings, bandages, antimicrobial agents, footwear, physical therapies and educational strategies. This review is one of a series of reviews, and focuses on the prevention and treatment of diabetic foot ulcers and the role of antimicrobial agents in chronic wounds in general. OBJECTIVES: To assess the clinical- and cost-effectiveness of (1) prevention and treatment strategies for diabetic foot ulcers and (2) systemic and topical antimicrobial agents in the prevention and healing of chronic wounds. METHODS - DATA SOURCES: Nineteen electronic databases were searched, including MEDLINE, CINAHL, Embase and the Cochrane Library. Relevant journals, conference proceedings and bibliographies of retrieved papers were hand-searched. An expert panel was consulted. METHODS - STUDY SELECTION: Randomised and non-randomised trials with a concurrent control group, which evaluated any intervention for the prevention or treatment of diabetic foot ulcers, or systemic or topical antimicrobials for chronic wounds (diabetic foot ulcers, pressure ulcers, leg ulcers of various aetiologies, pilonidal sinuses, non-healing surgical wounds, and cavity wounds) and used objective measures of outcome such as: (1) development or resolution of callus; (2) incidence of ulceration (for diabetic foot ulcer prevention studies); (3) incidence of pressure sores (pressure sore prevention studies); (4) any objective measure of wound healing (frequency of complete healing, change in wound size, time to healing, rate of healing); (5) ulcer recurrence rates; (6) side-effects; (7) amputation rates (diabetic foot ulcer treatment studies); (8) healing rates and recurrence of disease, among others, for pilonidal sinuses. Studies reporting solely microbiological outcomes were excluded. Decisions on the inclusion of primary studies were made independently by two reviewers. Disagreements were resolved through discussion. Data were extracted by one reviewer into structured summary tables. Data extraction was checked independently by a second reviewer and discrepancies resolved by discussion. All included studies were assessed against a comprehensive checklist for methodological quality. INCLUDED STUDIES - DIABETIC FOOT ULCERS: Thirty-nine trials which evaluated various prevention and treatment modalities for diabetic foot ulcers: footwear (2), hosiery (1), education (5), screening and foot protection programme (1); podiatry (1) for the prevention of diabetic foot ulcers; and footwear (1), skin replacement (2), hyperbaric oxygen (2), ketanserin (3), prostaglandins (3), growth factors (5), dressings and topical applications (9), debridement (2) and antibiotics (2) for the treatment of diabetic foot ulcers. INCLUDED STUDIES - ANTIMICROBIALS: Thirty studies were included, 25 with a randomised design. There were nine evaluations of systemic antimicrobials and 21 of topical agents. QUALITY OF STUDIES: The methodological and reporting quality was generally poor. Commonly encountered problems of reporting included lack of clarity about randomisation and outcome measurement procedures, and lack of baseline descriptive data. Common methodological weaknesses included: lack of blinded outcome assessment and lack of adjustment for baseline differences in important variables such as wound size; large loss to follow-up; and no intention-to-treat analysis. RESULTS - PREVENTION OF DIABETIC FOOT ULCERS: There is some evidence (1 large trial) that a screening and foot protection programme reduces the rate of major amputations. The evidence for special footwear (2 small trials) and educational programmes (5 trials) is equivocal. A single trial of podiatric care reported a significantly greater reduction in callus in patients receiving podiatric care. RESULTS - TREATMENT OF DIABETIC FOOT ULCERS: Total contact casting healed significantly more ulcers than did standard treatment in one study. There is evidence from 5 trials of topical growth factors to suggest that these, particularly platelet-derived growth factor, may increase the healing rate of diabetic foot ulcers. Although these studies were of relatively good quality, the sample sizes were far too small to make any definitive conclusions, and growth factors should be compared with current standard treatments in large, multicentre studies. Topical ketanserin increased ulcer healing rate in 2 studies, while systemic hyperbaric oxygen therapy reduced the rate of major amputations in 1 study. Preliminary research into the effects of iloprost and prostaglandin E1 (PGE1) on diabetic foot ulcer healing suggests possible benefits. However, good quality, large-scale confirmatory research is needed. (ABSTRACT TRUNCATED)

Administration, Topical↗
PubMed2000

A systematic review to evaluate the effectiveness of interventions to promote the initiation of breastfeeding.

BACKGROUND: Human breastmilk provides complete nutrition for infants and helps protect against certain childhood diseases. Despite this, rates of initiation of breastfeeding in the UK remain low relative to other countries. In 'Our healthier nation' action report, the government has highlighted the promotion of breastfeeding in order to assist improvements in health and to reduce the health inequalities of mothers and children in the UK. OBJECTIVES: The primary aim of this systematic review was to evaluate existing evidence to identify which promotion programmes are effective at increasing the number of women who start to breastfeed. In addition, the review aimed to assess the impact of such programmes on the duration and/or exclusivity of breastfeeding and the intermediate and process outcomes. Where the strength and quality of the evidence permitted, the review aimed to identify implications for practice within the UK and priority areas for future research. METHODS DATA SOURCES: A range of electronic databases were searched from inception to November 1998, several relevant journals were hand-searched, and references of retrieved papers were examined. Relevant experts, organisations and lay groups were contacted to help identify further published or unpublished material. Additionally, an expert panel was consulted. SELECTION CRITERIA: Four types of criteria were used to select eligible studies for this review: STUDY DESIGN - randomised controlled trials (RCTs), non-RCTs with concurrent controls, and before-after studies (cohort or cross-sectional). PARTICIPANTS - pregnant women, mothers in the immediate postpartum period before the first breastfeed, any participant linked to pregnant women or new mothers, or any participant who may breastfeed in the future, or be linked to a breastfeeding woman in the future. INTERVENTIONS - any type of intervention designed to promote the uptake of breastfeeding was included; control groups could receive an alternative breastfeeding promotion programme or standard care. OUTCOMES - the primary outcome was initiation of breastfeeding; secondary outcomes (duration and exclusivity of breastfeeding) were included if initiation was reported in the same study; intermediate and process outcomes were also included, and need not necessarily be associated with reported initiation rates. DATA EXTRACTION AND VALIDITY ASSESSMENT: Data were extracted into structured tables. All included studies were checked against a comprehensive methodological checklist. Different checklists were used for RCTs, non-RCTs and before-after studies. Data extraction and validity assessment were independently checked by a second reviewer. DATA SYNTHESIS: The studies were grouped according to intervention type, and were combined using a narrative synthesis. For individual RCTs and non-RCTs reporting initiation of breastfeeding, relative risks with associated 95% confidence intervals were estimated, with calculations performed on an intention-to-treat basis where possible. Pooling of relative risks was considered inappropriate owing to the lack of similarity across the studies. RESULTS: A total of 59 studies met the selection criteria, comprising 14 RCTs, 16 non-RCTs and 29 before-after studies. Interventions were grouped into the following categories: health education, health sector initiatives (HSI) - general, HSI - Baby Friendly Hospital Initiative (BFHI), HSI - training of health professionals, HSI - US Department of Agriculture's Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), HSI - social support from health professionals, peer support, media campaigns, multifaceted interventions. In many cases, studies were dissimilar in terms of the type of intervention(s), participants and the definitions of outcomes. Methodological problems of some studies also limited interpretation of findings. (ABSTRACT TRUNCATED)

Breast Feeding↗