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PLoS Medicine Feb 2014Trachoma is the world's leading cause of infectious blindness. The World Health Organization (WHO) has endorsed the SAFE strategy in order to eliminate blindness due to... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Trachoma is the world's leading cause of infectious blindness. The World Health Organization (WHO) has endorsed the SAFE strategy in order to eliminate blindness due to trachoma by 2020 through "surgery," "antibiotics," "facial cleanliness," and "environmental improvement." While the S and A components have been widely implemented, evidence and specific targets are lacking for the F and E components, of which water, sanitation, and hygiene (WASH) are critical elements. Data on the impact of WASH on trachoma are needed to support policy and program recommendations. Our objective was to systematically review the literature and conduct meta-analyses where possible to report the effects of WASH conditions on trachoma and identify research gaps.
METHODS AND FINDINGS
We systematically searched PubMed, Embase, ISI Web of Knowledge, MedCarib, Lilacs, REPIDISCA, DESASTRES, and African Index Medicus databases through October 27, 2013 with no restrictions on language or year of publication. Studies were eligible for inclusion if they reported a measure of the effect of WASH on trachoma, either active disease indicated by observed signs of trachomatous inflammation or Chlamydia trachomatis infection diagnosed using PCR. We identified 86 studies that reported a measure of the effect of WASH on trachoma. To evaluate study quality, we developed a set of criteria derived from the GRADE methodology. Publication bias was assessed using funnel plots. If three or more studies reported measures of effect for a comparable WASH exposure and trachoma outcome, we conducted a random-effects meta-analysis. We conducted 15 meta-analyses for specific exposure-outcome pairs. Access to sanitation was associated with lower trachoma as measured by the presence of trachomatous inflammation-follicular or trachomatous inflammation-intense (TF/TI) (odds ratio [OR] 0.85, 95% CI 0.75-0.95) and C. trachomatis infection (OR 0.67, 95% CI 0.55-0.78). Having a clean face was significantly associated with reduced odds of TF/TI (OR 0.42, 95% CI 0.32-0.52), as were facial cleanliness indicators lack of ocular discharge (OR 0.42, 95% CI 0.23-0.61) and lack of nasal discharge (OR 0.62, 95% CI 0.52-0.72). Facial cleanliness indicators were also associated with reduced odds of C. trachomatis infection: lack of ocular discharge (OR 0.40, 95% CI 0.31-0.49) and lack of nasal discharge (OR 0.56, 95% CI 0.37-0.76). Other hygiene factors found to be significantly associated with reduced TF/TI included face washing at least once daily (OR 0.76, 95% CI 0.57-0.96), face washing at least twice daily (OR 0.85, 95% CI 0.80-0.90), soap use (OR 0.76, 95% CI 0.59-0.93), towel use (OR 0.65, 95% CI 0.53-0.78), and daily bathing practices (OR 0.76, 95% CI 0.53-0.99). Living within 1 km of a water source was not found to be significantly associated with TF/TI or C. trachomatis infection, and the use of sanitation facilities was not found to be significantly associated with TF/TI.
CONCLUSIONS
We found strong evidence to support F and E components of the SAFE strategy. Though limitations included moderate to high heterogenity, low study quality, and the lack of standard definitions, these findings support the importance of WASH in trachoma elimination strategies and the need for the development of standardized approaches to measuring WASH in trachoma control programs.
Topics: Chlamydia trachomatis; Face; Humans; Hygiene; Odds Ratio; Risk Factors; Sanitation; Skin; Skin Care; Soaps; Trachoma; Water Microbiology; Water Supply
PubMed: 24586120
DOI: 10.1371/journal.pmed.1001605 -
Health Technology Assessment... Dec 2013The principal diagnosis/indication for this assessment is chronic diarrhoea due to bile acid malabsorption (BAM). Diarrhoea can be defined as the abnormal passage of... (Review)
Review
SeHCAT [tauroselcholic (selenium-75) acid] for the investigation of bile acid malabsorption and measurement of bile acid pool loss: a systematic review and cost-effectiveness analysis.
BACKGROUND
The principal diagnosis/indication for this assessment is chronic diarrhoea due to bile acid malabsorption (BAM). Diarrhoea can be defined as the abnormal passage of loose or liquid stools more than three times daily and/or a daily stool weight > 200 g per day and is considered to be chronic if it persists for more than 4 weeks. The cause of chronic diarrhoea in adults is often difficult to ascertain and patients may undergo several investigations without a definitive cause being identified. BAM is one of several causes of chronic diarrhoea and results from failure to absorb bile acids (which are required for the absorption of dietary fats and sterols in the intestine) in the distal ileum.
OBJECTIVE
For people with chronic diarrhoea with unknown cause and in people with Crohn's disease and chronic diarrhoea with unknown cause (i.e. before resection): (1) What are the effects of selenium-75-homocholic acid taurine (SeHCAT) compared with no SeHCAT in terms of chronic diarrhoea, other health outcomes and costs? (2) What are the effects of bile acid sequestrants (BASs) compared with no BASs in people with a positive or negative SeHCAT test? (3) Does a positive or negative SeHCAT test predict improvement in terms of chronic diarrhoea, other health outcomes and costs?
DATA SOURCES
A systematic review was conducted to summarise the evidence on the clinical effectiveness of SeHCAT for the assessment of BAM and the measurement of bile acid pool loss. Search strategies were based on target condition and intervention, as recommended in the Centre for Reviews and Dissemination (CRD) guidance for undertaking reviews in health care and the Cochrane Handbook for Diagnostic Test Accuracy Reviews. The following databases were searched up to April 2012: MEDLINE; MEDLINE In-Process & Other Non-Indexed Citations; EMBASE; the Cochrane Databases; Database of Abstracts of Reviews of Effects; Health Technology Assessment (HTA) Database; and Science Citation Index. Research registers and conference proceedings were also searched.
REVIEW METHODS
Systematic review methods followed the principles outlined in the CRD guidance for undertaking reviews in health care and the National Institute for Health and Care Excellence (NICE) Diagnostic Assessment Programme interim methods statement. In the health economic analysis, the cost-effectiveness of SeHCAT for the assessment of BAM, in patients with chronic diarrhoea, was estimated in two different populations. The first is the population of patients with chronic diarrhoea with unknown cause and symptoms suggestive of diarrhoea-predominant irritable bowel syndrome (IBS-D) and the second population concerns patients with Crohn's disease without ileal resection with chronic diarrhoea. For each population, three models were combined: (1) a short-term decision tree that models the diagnostic pathway and initial response to treatment (first 6 months); (2) a long-term Markov model that estimates the lifetime costs and effects for patients initially receiving BAS; and (3) a long-term Markov model that estimates the lifetime costs and effects for patients initially receiving regular treatment (IBS-D treatment in the first population and Crohn's treatment in the second population). Incremental cost-effectiveness ratios were estimated as additional cost per additional responder in the short term (first 6 months) and per additional quality-adjusted life-year (QALY) in the long term (lifetime).
RESULTS
We found three studies assessing the relationship between the SeHCAT test and response to treatment with cholestyramine. However, the studies had small numbers of patients with unknown cause chronic diarrhoea, and they used different cut-offs to define BAM. For the short term (first 6 months), when trial of treatment is not considered as a comparator, the optimal choice depends on the willingness to pay for an additional responder. For lower values (between £1500 and £4600) the choice will be no SeHCAT in all scenarios; for higher values either SeHCAT 10% or SeHCAT 15% becomes cost-effective. For the lifetime perspective, the various scenarios showed widely differing results: in the threshold range of £20,000-30,000 per QALY gained we found as optimal choice either no SeHCAT, SeHCAT 5% (only IBS-D) or SeHCAT 15%. When trial of treatment is considered a comparator, the analysis showed that for the short term, trial of treatment is the optimal choice across a range of scenarios. For the lifetime perspective with trial of treatment, again the various scenarios show widely differing results. Depending on the scenario, in the threshold range of £20,000-30,000 per QALY gained, we found as optimal choice either trial of treatment, no SeHCAT or SeHCAT 15%.
CONCLUSIONS
In conclusion, the various analyses show that for both populations considerable decision uncertainty exists and that no firm conclusions can be formulated about which strategy is optimal. Standardisation of the definition of a positive SeHCAT test should be the first step in assessing the usefulness of this test. As there is no reference standard for the diagnosis of BAM and SeHCAT testing provides a continuous measure of metabolic function, diagnostic test accuracy (DTA) studies are not the most appropriate study design. However, in studies where all patients are tested with SeHCAT and all patients are treated with BASs, response to treatment can provide a surrogate reference standard; further DTA studies of this type may provide information on the ability of SeHCAT to predict response to BASs. A potentially more informative option would be multivariate regression modelling of treatment response (dependent variable), with SeHCAT result and other candidate clinical predictors as covariates. Such a study design could also inform the definition of a positive SeHCAT result.
STUDY REGISTRATION
The study is registered as PROSPERO CRD42012001911.
FUNDING
The National Institute for Health Research Health Technology Assessment programme.
Topics: Adult; Bile Acids and Salts; Chronic Disease; Cost-Benefit Analysis; Crohn Disease; Diagnosis, Differential; Diarrhea; Humans; Irritable Bowel Syndrome; Malabsorption Syndromes; Models, Economic; Predictive Value of Tests; Taurocholic Acid; United Kingdom
PubMed: 24351663
DOI: 10.3310/hta17610 -
The Cochrane Database of Systematic... Sep 2012Surgical site infections (SSIs) are wound infections that occur after invasive (surgical) procedures. Preoperative bathing or showering with an antiseptic skin wash... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Surgical site infections (SSIs) are wound infections that occur after invasive (surgical) procedures. Preoperative bathing or showering with an antiseptic skin wash product is a well-accepted procedure for reducing skin bacteria (microflora). It is less clear whether reducing skin microflora leads to a lower incidence of surgical site infection.
OBJECTIVES
To review the evidence for preoperative bathing or showering with antiseptics for preventing hospital-acquired (nosocomial) surgical site infections.
SEARCH METHODS
For this fourth update we searched the Cochrane Wounds Group Specialised Register (searched 29 June 2012); the Cochrane Central Register of Controlled Trials (The Cochrane Library 2012 Issue 6); Ovid MEDLINE (2010 to June Week 3 2012), Ovid MEDLINE (In-Process & Other Non-Indexed Citations June 27, 2012); Ovid EMBASE (2010 to 2012 Week 25), EBSCO CINAHL (1882 to 21 June 2012) and reference lists of articles.
SELECTION CRITERIA
Randomised controlled trials comparing any antiseptic preparation used for preoperative full-body bathing or showering with non-antiseptic preparations in people undergoing surgery.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed studies for selection, risk of bias and extracted data. Study authors were contacted for additional information.
MAIN RESULTS
We did not identify any new trials for inclusion in this fourth update. Seven trials involving a total of 10,157 participants were included. Four of the included trials had three comparison groups. The antiseptic used in all trials was 4% chlorhexidine gluconate (Hibiscrub/Riohex). Three trials involving 7791 participants compared chlorhexidine with a placebo. Bathing with chlorhexidine compared with placebo did not result in a statistically significant reduction in SSIs; the relative risk of SSI (RR) was 0.91 (95% confidence interval (CI) 0.80 to 1.04). When only trials of high quality were included in this comparison, the RR of SSI was 0.95 (95%CI 0.82 to 1.10). Three trials of 1443 participants compared bar soap with chlorhexidine; when combined there was no difference in the risk of SSIs (RR 1.02, 95% CI 0.57 to 1.84). Three trials of 1192 patients compared bathing with chlorhexidine with no washing, one large study found a statistically significant difference in favour of bathing with chlorhexidine (RR 0.36, 95%CI 0.17 to 0.79). The smaller studies found no difference between patients who washed with chlorhexidine and those who did not wash preoperatively.
AUTHORS' CONCLUSIONS
This review provides no clear evidence of benefit for preoperative showering or bathing with chlorhexidine over other wash products, to reduce surgical site infection. Efforts to reduce the incidence of nosocomial surgical site infection should focus on interventions where effect has been demonstrated.
Topics: Anti-Infective Agents, Local; Baths; Chlorhexidine; Disinfection; Female; Humans; Male; Preoperative Care; Randomized Controlled Trials as Topic; Soaps; Surgical Wound Infection
PubMed: 22972080
DOI: 10.1002/14651858.CD004985.pub4 -
The Cochrane Database of Systematic... Dec 2011Sclerotherapy has been used in clinical practice for centuries, but there is still no consensus about which, if any, sclerosing agent provides the best results. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Sclerotherapy has been used in clinical practice for centuries, but there is still no consensus about which, if any, sclerosing agent provides the best results.
OBJECTIVES
To assess the effectiveness and safety of sclerosing agents in the treatment of telangiectasias of the lower limbs.
SEARCH METHODS
The Cochrane Peripheral Vascular Diseases (PVD) Group searched their Specialised Register (last searched 26 May 2011) and CENTRAL (2011, Issue 2). We searched references within identified studies and from the Cited References in the Web of Science. We contacted study authors and pharmaceutical companies. There were no language restrictions.
SELECTION CRITERIA
We included randomised or quasi-randomised controlled trials on the treatment of telangiectasias comparing sclerotherapy with a normal saline placebo, no treatment or an alternative sclerotherapy regimen.
DATA COLLECTION AND ANALYSIS
Both authors determined which studies to include, extracted the data and rated risk of bias. One author (LS) contacted study authors and pharmaceutical companies and analysed the results.
MAIN RESULTS
Ten studies involving 484 patients were included. There was no evidence suggesting superior efficacy of any one sclerosant over another, but there was evidence of superiority of sclerotherapy to placebo.The evidence did not suggest an increase in patient satisfaction with any one agent versus another, but there was evidence that patients were less satisfied with placebo.There was some evidence suggesting that polidocanol (POL) was more likely to cause adverse reactions at a concentration of 1% compared with lower concentrations or hypertonic saline, and that sodium tetradecyl sulfate (STS) was more likely to cause adverse reactions at a concentration of 1% compared with POL at 0.5%.There was some evidence suggesting that STS was more painful than POL, heparsal (20% saline mixed with heparin 100 units/mL) or placebo, and that POL was no more painful than placebo. Evidence from one study suggested that hypertonic saline (HS) was more painful than POL.The data were not suitable for meta-analysis.
AUTHORS' CONCLUSIONS
The evidence did not suggest superior efficacy or patient satisfaction for any one sclerosing agent used in the treatment of telangiectasias of the lower limbs, but the agents studied showed superiority to a normal saline placebo. However, the amount of available evidence in this field is small and the overall methodological quality of the research was poor, as was the quality of reporting. More research is needed to determine the optimal agent(s) and the ideal dosing to achieve the best results and maximize patient satisfaction. Future research efforts should incorporate more demographic data and symptom measures to allow for comparison with findings from observational studies, thereby aiding assessment of how various risk groups respond to treatment.
Topics: Heparin; Humans; Leg; Patient Satisfaction; Polidocanol; Polyethylene Glycols; Randomized Controlled Trials as Topic; Sclerosing Solutions; Sclerotherapy; Sodium Chloride; Sodium Tetradecyl Sulfate; Telangiectasis
PubMed: 22161437
DOI: 10.1002/14651858.CD008826.pub2 -
British Journal of Sports Medicine Jul 2009To appraise existing evidence for prolotherapy, polidocanol, autologous whole blood and platelet-rich plasma injection therapies for lateral epicondylosis (LE). (Review)
Review
OBJECTIVE
To appraise existing evidence for prolotherapy, polidocanol, autologous whole blood and platelet-rich plasma injection therapies for lateral epicondylosis (LE).
DESIGN
Systematic review.
DATA SOURCES
Medline, Embase, CINAHL, Cochrane Central Register of Controlled Trials, Allied and Complementary Medicine.
SEARCH STRATEGY
names and descriptors of the therapies and LE.
STUDY SELECTION
All human studies assessing the four therapies for LE.
MAIN RESULTS
Results of five prospective case series and four controlled trials (three prolotherapy, two polidocanol, three autologous whole blood and one platelet-rich plasma) suggest each of the four therapies is effective for LE. In follow-up periods ranging from 9 to 108 weeks, studies reported sustained, statistically significant (p<0.05) improvement in visual analogue scale primary outcome pain score measures and disease-specific questionnaires; relative effect sizes ranged from 51% to 94%; Cohen's d ranged from 0.68 to 6.68. Secondary outcomes also improved, including biomechanical elbow function assessment (polidocanol and prolotherapy), presence of abnormalities and increased vascularity on ultrasound (autologous whole blood and polidocanol). Subjects reported satisfaction with therapies on single-item assessments. All studies were limited by small sample size.
CONCLUSIONS
There is strong pilot-level evidence supporting the use of prolotherapy, polidocanol, autologous whole blood and platelet-rich plasma injections in the treatment of LE. Rigorous studies of sufficient sample size, assessing these injection therapies using validated clinical, radiological and biomechanical measures, and tissue injury/healing-responsive biomarkers, are needed to determine long-term effectiveness and safety, and whether these techniques can play a definitive role in the management of LE and other tendinopathies.
Topics: Blood Transfusion, Autologous; Humans; Injections; Naturopathy; Platelet-Rich Plasma; Polidocanol; Polyethylene Glycols; Randomized Controlled Trials as Topic; Sclerosing Solutions; Tennis Elbow
PubMed: 19028733
DOI: 10.1136/bjsm.2008.052761 -
The Cochrane Database of Systematic... Oct 2007Trials have assessed bile acids for patients with viral hepatitis, but no consensus has been reached regarding their usefulness. (Review)
Review
BACKGROUND
Trials have assessed bile acids for patients with viral hepatitis, but no consensus has been reached regarding their usefulness.
OBJECTIVES
To assess the beneficial and harmful effects of bile acids for viral hepatitis.
SEARCH STRATEGY
Searches were performed in The Cochrane Hepato-Biliary Group Controlled Trials Register (July 2007), The Cochrane Library (Issue 1, 2007), MEDLINE (July 2007), EMBASE (July 2007), Science Citation Index Expanded (July 2007), and Chinese Biomedical Database (July 2007).
SELECTION CRITERIA
Randomised clinical trials comparing any dose or duration of bile acids versus placebo or no intervention for viral hepatitis were included, irrespective of language, publication status, or blinding. Co-interventions were allowed in the included randomised clinical trials.
DATA COLLECTION AND ANALYSIS
Two authors extracted the data independently. The methodological quality of the trials was evaluated with respect to generation of the allocation sequence, allocation concealment, double blinding, and follow-up. The outcomes were presented as relative risks (RR) or weighted mean differences (WMD) with 95% confidence intervals (CI).
MAIN RESULTS
We identified 29 randomised trials of bile acids for hepatitis B or C; none were of high methodological quality. We were unable to extract data from two trials. In one trial, ursodeoxycholic acid (UDCA) versus placebo for acute hepatitis B significantly reduced the risk of hepatitis B surface antigen positivity at the end of treatment and serum HBV DNA level at the end of follow-up. In another trial, UDCA versus no intervention for chronic hepatitis B significantly reduced the risk of having abnormal serum transaminase activities at the end of treatment. Twenty-five trials compared bile acids (21 trials UDCA; four trials tauro-UDCA) versus placebo or no intervention with or without co-interventions for chronic hepatitis C. Bile acids did not significantly reduce the risk of having detectable serum HCV RNA (RR 0.99, 95% CI 0.91 to 1.07), cirrhosis, or portal and periportal inflammation score at the end of treatment. Bile acids significantly decreased the risk of having abnormal serum alanine aminotransferase activity at the end of treatment (RR 0.82, 95% CI 0.76 to 0.90) and follow-up (RR 0.91, 95% CI 0.85 to 0.98). Bile acids significantly increased the Knodell score (WMD 0.20, 95% CI 0.08 to 0.31) at the end of treatment. No severe adverse events were reported. We did not identify trials including patients with hepatitis A, acute hepatitis C, hepatitis D, or hepatitis E.
AUTHORS' CONCLUSIONS
Bile acids lead to a significant improvement in serum transaminase activities in hepatitis B and C but have no effects on the clearance of virus. There is insufficient evidence either to support or to refute effects on long-term outcomes including hepatocellular carcinoma, hepatic decompensation, and liver related mortality. Randomised trials with high methodological quality are required before clinical use is considered.
Topics: Antiviral Agents; Hepatitis B, Chronic; Hepatitis C, Chronic; Hepatitis, Viral, Human; Humans; Randomized Controlled Trials as Topic; Taurochenodeoxycholic Acid; Ursodeoxycholic Acid
PubMed: 17943781
DOI: 10.1002/14651858.CD003181.pub2