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BMC Geriatrics Jan 2017For immobile patients, a body wash in bed is sometimes the only bathing option. Traditionally, the bed bath is performed with water and soap. However, alternatives are... (Review)
Review
BACKGROUND
For immobile patients, a body wash in bed is sometimes the only bathing option. Traditionally, the bed bath is performed with water and soap. However, alternatives are increasingly used in health care. Washing without water is one such alternative that has been claimed to offer several advantages, such as improved hygiene and skin condition. This systematic review aims to provide a comprehensive overview of the evidence on outcomes of the washing without water concept compared to the traditional bed bath.
METHODS
Controlled trials about washing without water outcomes published after 1994 were collected by means of a systematic literature search in CINAHL, Embase, MEDLINE, and PUBMED at the 25th of February, 2016. Additionally, references and citations were searched and experts contacted. Studies were eligible if (1) the study designs included outcomes of washing without water products developed for the full body wash compared to the traditional bed bath, and (2) they were controlled trials. Two researchers independently used a standardized quality checklist to assess the methodological quality of the eligible studies. Finally, outcomes were categorized in (1) physiological outcomes related to hygiene and skin condition, (2) stakeholder-related outcomes, and (3) organizational outcomes in the data synthesis.
RESULTS
Out of 33 potentially relevant articles subjected to full text screening, six studies met the eligibility criteria. Only two studies (of the same research group) were considered of high quality. The results of these high quality studies show that washing without water performed better than the traditional bed bath regarding skin abnormalities and bathing completeness. No differences between washing without water and the traditional bed bath were found for outcomes related to significant skin lesions, resistance during bathing and costs in the studies of high quality.
CONCLUSIONS
There is limited moderate to high quality evidence that washing without water is not inferior to the traditional bed bath. Future research on washing without water is needed and should pay special attention to costs, hygiene, and to stakeholder-related outcomes, such as experiences and value perceptions of patients, nursing staff and family.
Topics: Baths; Disabled Persons; Humans; Hygiene; Sanitation; Soaps; Water
PubMed: 28118815
DOI: 10.1186/s12877-017-0425-4 -
International Journal of Environmental... Sep 2022Severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) is a global and evolving pandemic associated with heavy health and financial burdens. Considering the oral... (Meta-Analysis)
Meta-Analysis Review
Severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) is a global and evolving pandemic associated with heavy health and financial burdens. Considering the oral cavity as the major reservoir for SARS-CoV-2, a systematic review and meta-analysis were conducted to assess the efficacy of mouth rinses and nasal sprays in reducing the salivary viral load of SARS-CoV-2. All and studies that assessed the virucidal efficacy of mouth rinses and nasal sprays against SARS-CoV-2 and were published in the English language from December 2019 to April 2022 were considered for analyses. Special Medical Subject Headings terms were used to search Pubmed, Scopus, Embase Ovid, and Web of Science databases. The toxicological data reliability assessment tool (ToxRToool) was used to assess the quality of the included studies. Thirty-three studies (11 and 22 ) were deemed eligible for inclusion in this analysis. Results of the pooled data showed that povidone-iodine is the most efficacious intervention in terms of reducing the SARS-CoV-2 salivary viral load, followed by chlorhexidine. The mean difference in the viral load was 86% and 72%, respectively. Similarly, povidone-iodine was associated with the highest log reduction value (LRV) , followed by cetylpyridinium chloride, (LRV = 2.938 ( < 0.0005) and LRV = 2.907 ( = 0.009), respectively). Povidone-iodine-based oral and nasal preparations showed favourable results in terms of reducing SARS-CoV-2 viral loads both and . Considering the limited number of patients , further studies among larger cohorts are recommended.
Topics: COVID-19; Cetylpyridinium; Chlorhexidine; Humans; Mouthwashes; Nasal Sprays; Povidone-Iodine; Reproducibility of Results; SARS-CoV-2
PubMed: 36231450
DOI: 10.3390/ijerph191912148 -
The Cochrane Database of Systematic... May 2015Achilles tendinopathy is a common condition, often with significant functional consequences. As a wide range of injection treatments are available, a review of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Achilles tendinopathy is a common condition, often with significant functional consequences. As a wide range of injection treatments are available, a review of randomised trials evaluating injection therapies to help inform treatment decisions is warranted.
OBJECTIVES
To assess the effects (benefits and harms) of injection therapies for people with Achilles tendinopathy.
SEARCH METHODS
We searched the following databases up to 20 April 2015: the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, AMED, CINAHL and SPORTDiscus. We also searched trial registers (29 May 2014) and reference lists of articles to identify additional studies.
SELECTION CRITERIA
We included randomised and quasi-randomised controlled trials evaluating injection therapies in adults with an investigator-reported diagnosis of Achilles tendinopathy. We accepted comparison arms of placebo (sham) or no injection control, or other active treatment (such as physiotherapy, pharmaceuticals or surgery). Our primary outcomes were function, using measures such as the VISA-A (Victorian Institute of Sport Assessment-Achilles questionnaire), and adverse events.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data from the included studies. We assessed treatment effects using mean differences (MDs) and 95% confidence intervals (CIs) for continuous variables and risk ratios (RRs) and 95% CIs for dichotomous variables. For follow-up data, we defined short-term as up to six weeks, medium-term as up to three months and longer-term as data beyond three months. We performed meta-analysis where appropriate.
MAIN RESULTS
We included 18 studies (732 participants). Seven trials exclusively studied athletic populations. The mean ages of the participants in the individual trials ranged from 20 years to 50 years. Fifteen trials compared an injection therapy with a placebo injection or no injection control, four trials compared an injection therapy with active treatment, and one compared two different concentrations of the same injection. Thus no trials compared different injection therapies. Two studies had three trial arms and we included them twice in two different categories. Within these categories, we further subdivided injection therapies by mode of action (injury-causing versus direct repair agents).The risk of bias was unclear (due to poor reporting) or high in six trials published between 1987 and 1994. Improved methodology and reporting for the subsequent trials published between 2004 and 2013 meant that these were at less risk of bias.Given the very low quality evidence available from each of four small trials comparing different combinations of injection therapy versus active treatment and the single trial comparing two doses of one injection therapy, only the results of the first comparison (injection therapy versus control) are presented.There is low quality evidence of a lack of significant or clinically important differences in VISA-A scores (0 to 100: best function) between injection therapy and control groups at six weeks (MD 0.79, 95% CI -4.56 to 6.14; 200 participants, five trials), three months (MD -0.94, 95% CI -6.34 to 4.46; 189 participants, five trials) or between six and 12 months (MD 0.14, 95% CI -6.54 to 6.82; 132 participants, three trials). Very low quality evidence from 13 trials showed little difference between the two groups in adverse events (14/243 versus 12/206; RR 0.97, 95% CI 0.50 to 1.89), most of which were minor and short-lasting. The only major adverse event in the injection therapy group was an Achilles tendon rupture, which happened in a trial testing corticosteroid injections. There was very low quality evidence in favour of the injection therapy group in short-term (under three months) pain (219 participants, seven trials) and in the return to sports (335 participants, seven trials). There was very low quality evidence indicating little difference between groups in patient satisfaction with treatment (152 participants, four trials). There was insufficient evidence to conclude on subgroup differences based on mode of action given that only two trials tested injury-causing agents and the clear heterogeneity of the other 13 trials, which tested seven different therapies that act directly on the repair pathway.
AUTHORS' CONCLUSIONS
There is insufficient evidence from randomised controlled trials to draw conclusions on the use, or to support the routine use, of injection therapies for treating Achilles tendinopathy. This review has highlighted a need for definitive research in the area of injection therapies for Achilles tendinopathy, including in older non-athletic populations. This review has shown that there is a consensus in the literature that placebo-controlled trials are considered the most appropriate trial design.
Topics: Achilles Tendon; Adrenal Cortex Hormones; Adult; Aprotinin; Athletes; Fibroblasts; Glycosaminoglycans; Hemodialysis Solutions; Humans; Injections, Intralesional; Middle Aged; Platelet Transfusion; Polidocanol; Polyethylene Glycols; Randomized Controlled Trials as Topic; Sodium Chloride; Tendinopathy; Young Adult
PubMed: 26009861
DOI: 10.1002/14651858.CD010960.pub2 -
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 -
International Archives of Occupational... Jan 2022Irritant contact dermatitis (ICD) is a major cause of occupational disease. The aim was to review the relation between exposure to occupational irritants and ICD and the... (Review)
Review
PURPOSE
Irritant contact dermatitis (ICD) is a major cause of occupational disease. The aim was to review the relation between exposure to occupational irritants and ICD and the prognosis of ICD.
METHODS
Through a systematic search, 1516 titles were identified, and 48 studies were included in the systematic review.
RESULTS
We found that the evidence for an association between ICD and occupational irritants was strong for wet work, moderate for detergents and non-alcoholic disinfectants, and strong for a combination. The highest quality studies provided limited evidence for an association with use of occlusive gloves without other exposures and moderate evidence with simultaneous exposure to other wet work irritants. The evidence for an association between minor ICD and exposure to metalworking fluids was moderate. Regarding mechanical exposures, the literature was scarce and the evidence limited. We found that the prognosis for complete healing of ICD is poor, but improves after decrease of exposure through change of occupation or work tasks. There was no substantial evidence for an influence of gender, age, or household exposures. Inclusion of atopic dermatitis in the analysis did not alter the risk of ICD. Studies were at risk of bias, mainly due to selection and misclassification of exposure and outcome. This may have attenuated the results.
CONCLUSION
This review reports strong evidence for an association between ICD and a combination of exposure to wet work and non-alcoholic disinfectants, moderate for metalworking fluids, limited for mechanical and glove exposure, and a strong evidence for a poor prognosis of ICD.
Topics: Dermatitis, Allergic Contact; Dermatitis, Atopic; Dermatitis, Irritant; Dermatitis, Occupational; Humans; Irritants; Occupational Exposure; Skin
PubMed: 34665298
DOI: 10.1007/s00420-021-01781-0 -
Alimentary Pharmacology & Therapeutics May 2014Bile acid malabsorption (BAM) is a common, yet under-recognised, cause of chronic diarrhoea, with limited guidance available on the appropriate management of patients... (Review)
Review
BACKGROUND
Bile acid malabsorption (BAM) is a common, yet under-recognised, cause of chronic diarrhoea, with limited guidance available on the appropriate management of patients with BAM.
AIM
To summarise the evidence supporting different treatments available for patients with bile acid malabsorption, noting their impact on clinical outcomes, tolerability and associated side effects.
METHODS
A literature search was conducted through PubMed, the Cochrane Database of Systematic Reviews and Scopus. Relevant articles studied patients who had been diagnosed with BAM and were clinically assessed before and after therapy.
RESULTS
A total of 30 relevant publications (1241 adult patients) were identified, which investigated the clinical response to drugs, including colestyramine, colestipol, colesevelam, aluminium hydroxide and obeticholic acid. The most commonly used diagnostic test of bile acid malabsorption was the SeHCAT test (24 studies). Colestyramine treatment was by far the most studied of these agents, and was successful in 70% of 801 patients (range: 63-100%).
CONCLUSIONS
Colestyramine and colestipol are generally effective treatments of gastrointestinal symptoms from BAM, but may be poorly tolerated and reduce the bioavailability of co-administered agents. Alternative therapies (including colesevelam and aluminium hydroxide) as well as dietary intervention may also have a role, and the promising results of the first proof-of-concept study of obeticholic acid suggest that its novel approach may have an exciting future in the treatment of this condition. Future trials should employ accurate diagnostic testing and be conducted over longer periods so that the long-term benefits and tolerability of these different approaches can be evaluated.
Topics: Adult; Anion Exchange Resins; Bile Acids and Salts; Chronic Disease; Diarrhea; Gastrointestinal Diseases; Humans; Steatorrhea; Taurocholic Acid
PubMed: 24602022
DOI: 10.1111/apt.12684 -
The Cochrane Database of Systematic... Sep 2015Diarrhoea accounts for 1.8 million deaths in children in low- and middle-income countries (LMICs). One of the identified strategies to prevent diarrhoea is hand washing. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Diarrhoea accounts for 1.8 million deaths in children in low- and middle-income countries (LMICs). One of the identified strategies to prevent diarrhoea is hand washing.
OBJECTIVES
To assess the effects of hand washing promotion interventions on diarrhoeal episodes in children and adults.
SEARCH METHODS
We searched the Cochrane Infectious Diseases Group Specialized Register (27 May 2015); CENTRAL (published in the Cochrane Library 2015, Issue 5); MEDLINE (1966 to 27 May 2015); EMBASE (1974 to 27 May 2015); LILACS (1982 to 27 May 2015); PsycINFO (1967 to 27 May 2015); Science Citation Index and Social Science Citation Index (1981 to 27 May 2015); ERIC (1966 to 27 May 2015); SPECTR (2000 to 27 May 2015); Bibliomap (1990 to 27 May 2015); RoRe, The Grey Literature (2002 to 27 May 2015); World Health Organization (WHO) International Clinical Trial Registry Platform (ICTRP), metaRegister of Controlled Trials (mRCT), and reference lists of articles up to 27 May 2015. We also contacted researchers and organizations in the field.
SELECTION CRITERIA
Individually randomized controlled trials (RCTs) and cluster-RCTs that compared the effects of hand washing interventions on diarrhoea episodes in children and adults with no intervention.
DATA COLLECTION AND ANALYSIS
Three review authors independently assessed trial eligibility, extracted data, and assessed risk of bias. We stratified the analyses for child day-care centres or schools, community, and hospital-based settings. Where appropriate, incidence rate ratios (IRR) were pooled using the generic inverse variance method and random-effects model with 95% confidence intervals (CIs). We used the GRADE approach to assess the quality of evidence.
MAIN RESULTS
We included 22 RCTs: 12 trials from child day-care centres or schools in mainly high-income countries (54,006 participants), nine community-based trials in LMICs (15,303 participants), and one hospital-based trial among people with acquired immune deficiency syndrome (AIDS) (148 participants).Hand washing promotion (education activities, sometimes with provision of soap) at child day-care facilities or schools prevents around one-third of diarrhoea episodes in high income countries (rate ratio 0.70; 95% CI 0.58 to 0.85; nine trials, 4664 participants, high quality evidence), and may prevent a similar proportion in LMICs but only two trials from urban Egypt and Kenya have evaluated this (rate ratio 0.66, 95% CI 0.43 to 0.99; two trials, 45,380 participants, low quality evidence). Only three trials reported measures of behaviour change and the methods of data collection were susceptible to bias. In one trial from the USA hand washing behaviour was reported to improve; and in the trial from Kenya that provided free soap, hand washing did not increase, but soap use did (data not pooled; three trials, 1845 participants, low quality evidence).Hand washing promotion among communities in LMICs probably prevents around one-quarter of diarrhoea episodes (rate ratio 0.72, 95% CI 0.62 to 0.83; eight trials, 14,726 participants, moderate quality evidence). However, six of these eight trials were from Asian settings, with only single trials from South America and sub-Saharan Africa. In six trials, soap was provided free alongside hand washing education, and the overall average effect size was larger than in the two trials which did not provide soap (soap provided: rate ratio 0.66, 95% CI 0.56 to 0.78; six trials, 11,422 participants; education only: rate ratio: 0.84, 95% CI 0.67 to 1.05; two trials, 3304 participants). There was increased hand washing at major prompts (before eating/cooking, after visiting the toilet or cleaning the baby's bottom), and increased compliance to hand hygiene procedure (behavioural outcome) in the intervention groups than the control in community trials (data not pooled: three trials, 3490 participants, high quality evidence).Hand washing promotion for the one trial conducted in a hospital among high-risk population showed significant reduction in mean episodes of diarrhoea (1.68 fewer) in the intervention group (Mean difference 1.68, 95% CI 1.93 to 1.43; one trial, 148 participants, moderate quality evidence). There was increase in hand washing frequency, seven times per day in the intervention group versus three times in the control in this hospital trial (one trial, 148 participants, moderate quality evidence).We found no trials evaluating or reporting the effects of hand washing promotions on diarrhoea-related deaths, all-cause-under five mortality, or costs.
AUTHORS' CONCLUSIONS
Hand washing promotion probably reduces diarrhoea episodes in both child day-care centres in high-income countries and among communities living in LMICs by about 30%. However, less is known about how to help people maintain hand washing habits in the longer term.
Topics: Adult; Child; Child Day Care Centers; Community-Acquired Infections; Cross Infection; Developed Countries; Developing Countries; Diarrhea; Hand Disinfection; Humans; Randomized Controlled Trials as Topic; Schools; Soaps
PubMed: 26346329
DOI: 10.1002/14651858.CD004265.pub3 -
The Cochrane Database of Systematic... Jul 2018Problems attributed to the accumulation of wax (cerumen) are among the most common reasons for people to present to their general practitioners with ear trouble.... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Problems attributed to the accumulation of wax (cerumen) are among the most common reasons for people to present to their general practitioners with ear trouble. Treatment for this condition often involves use of a wax softening agent (cerumenolytic) to disperse the cerumen, reduce the need for, or facilitate syringing, but there is no consensus on the effectiveness of the variety of cerumenolytics in use.
OBJECTIVES
To assess the effectiveness of ear drops (cerumenolytics) for the removal of symptomatic ear wax.
SEARCH METHODS
We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2008 issue 2); MEDLINE; EMBASE; CINAHL; ISI Proceedings; Cambridge Scientific Abstracts; mRCT and additional sources for published and unpublished trials. The date of the most recent search was April 2008.
SELECTION CRITERIA
We identified all randomised controlled trials in which a cerumenolytic was compared with no treatment, a placebo, or other cerumenolytics in participants with obstructing or impacted ear wax, and in which the proportion of participants with sufficient clearance of the external canal to make further mechanical clearance unnecessary (primary outcome measure) was stated or calculable.
DATA COLLECTION AND ANALYSIS
The two authors reviewed all the retrieved trials and applied the inclusion criteria independently.
MAIN RESULTS
Nine trials satisfied the inclusion criteria. In all, 679 participants received one of 11 different cerumenolytics. One trial compared active treatments with no treatment, three compared active treatments with water or a saline 'placebo', and all nine trials compared two or more active treatments. Eight trials included syringing as a secondary intervention.Overall, results were inconclusive. The majority of comparisons showed no difference between treatments. Meta-analysis of two high quality trials produced a statistical difference in favour of triethanolamine polypeptide over saline in preventing the need for syringing, but no other significant differences between treatments.In three trials of high to moderate quality, no difference was found between the effectiveness of either sodium bicarbonate ear drops, chlorbutanol, triethanolamine polypeptide oleate condensate or docusate sodium liquid versus a sterile water or saline 'placebo'.One trial of moderate methodological quality found all three treatments - sodium bicarbonate ear drops, chlorbutanol and sterile water - to be significantly better than no treatment at preventing the need for syringing.None of the higher quality trials demonstrated superiority of one agent over another in direct comparisons.
AUTHORS' CONCLUSIONS
Trials have been heterogeneous and generally of low or moderate quality, making it difficult to offer any definitive recommendations on the effectiveness of cerumenolytics for the removal of symptomatic ear wax. Using drops of any sort appears to be better than no treatment, but it is uncertain if one type of drop is any better than another. Future trials should be of high methodological quality, have large sample sizes, and compare both oil-based and water-based solvents with placebo, no treatment or both.
Topics: Cerumen; Detergents; Humans; Randomized Controlled Trials as Topic; Solvents; Syringes
PubMed: 30040120
DOI: 10.1002/14651858.CD004326.pub3 -
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... Apr 2018Occupational irritant hand dermatitis (OIHD) causes significant functional impairment, disruption of work, and discomfort in the working population. Different preventive... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Occupational irritant hand dermatitis (OIHD) causes significant functional impairment, disruption of work, and discomfort in the working population. Different preventive measures such as protective gloves, barrier creams and moisturisers can be used, but it is not clear how effective these are. This is an update of a Cochrane review which was previously published in 2010.
OBJECTIVES
To assess the effects of primary preventive interventions and strategies (physical and behavioural) for preventing OIHD in healthy people (who have no hand dermatitis) who work in occupations where the skin is at risk of damage due to contact with water, detergents, chemicals or other irritants, or from wearing gloves.
SEARCH METHODS
We updated our searches of the following databases to January 2018: the Cochrane Skin Specialised Register, CENTRAL, MEDLlNE, and Embase. We also searched five trials registers and checked the bibliographies of included studies for further references to relevant trials. We handsearched two sets of conference proceedings.
SELECTION CRITERIA
We included parallel and cross-over randomised controlled trials (RCTs) which examined the effectiveness of barrier creams, moisturisers, gloves, or educational interventions compared to no intervention for the primary prevention of OIHD under field conditions.
DATA COLLECTION AND ANALYSIS
We used the standard methodological procedures expected by Cochrane. The primary outcomes were signs and symptoms of OIHD developed during the trials, and the frequency of treatment discontinuation due to adverse effects.
MAIN RESULTS
We included nine RCTs involving 2888 participants without occupational irritant hand dermatitis (OIHD) at baseline. Six studies, including 1533 participants, investigated the effects of barrier creams, moisturisers, or both. Three studies, including 1355 participants, assessed the effectiveness of skin protection education on the prevention of OIHD. No studies were eligible that investigated the effects of protective gloves. Among each type of intervention, there was heterogeneity concerning the criteria for assessing signs and symptoms of OIHD, the products, and the occupations. Selection bias, performance bias, and reporting bias were generally unclear across all studies. The risk of detection bias was low in five studies and high in one study. The risk of other biases was low in four studies and high in two studies.The eligible trials involved a variety of participants, including: metal workers exposed to cutting fluids, dye and print factory workers, gut cleaners in swine slaughterhouses, cleaners and kitchen workers, nurse apprentices, hospital employees handling irritants, and hairdressing apprentices. All studies were undertaken at the respective work places. Study duration ranged from four weeks to three years. The participants' ages ranged from 16 to 67 years.Meta-analyses for barrier creams, moisturisers, a combination of both barrier creams and moisturisers, or skin protection education showed imprecise effects favouring the intervention. Twenty-nine per cent of participants who applied barrier creams developed signs of OIHD, compared to 33% of the controls, so the risk may be slightly reduced with this measure (risk ratio (RR) 0.87, 95% confidence interval (CI) 0.72 to 1.06; 999 participants; 4 studies; low-quality evidence). However, this risk reduction may not be clinically important. There may be a clinically important protective effect with the use of moisturisers: in the intervention groups, 13% of participants developed symptoms of OIHD compared to 19% of the controls (RR 0.71, 95% CI 0.46 to 1.09; 507 participants; 3 studies; low-quality evidence). Likewise, there may be a clinically important protective effect from using a combination of barrier creams and moisturisers: 8% of participants in the intervention group developed signs of OIHD, compared to 13% of the controls (RR 0.68, 95% CI 0.33 to 1.42; 474 participants; 2 studies; low-quality evidence). We are uncertain whether skin protection education reduces the risk of developing signs of OIHD (RR 0.76, 95% CI 0.54 to 1.08; 1355 participants; 3 studies; very low-quality evidence). Twenty-one per cent of participants who received skin protection education developed signs of OIHD, compared to 28% of the controls.None of the studies addressed the frequency of treatment discontinuation due to adverse effects of the products directly. However, in three studies of barrier creams, the reasons for withdrawal from the studies were unrelated to adverse effects. Likewise, in one study of moisturisers plus barrier creams, and in one study of skin protection education, reasons for dropout were unrelated to adverse effects. The remaining studies (one to two in each comparison) reported dropouts without stating how many of them may have been due to adverse reactions to the interventions. We judged the quality of this evidence as moderate, due to the indirectness of the results. The investigated interventions to prevent OIHD probably cause few or no serious adverse effects.
AUTHORS' CONCLUSIONS
Moisturisers used alone or in combination with barrier creams may result in a clinically important protective effect, either in the long- or short-term, for the primary prevention of OIHD. Barrier creams alone may have slight protective effect, but this does not appear to be clinically important. The results for all of these comparisons were imprecise, and the low quality of the evidence means that our confidence in the effect estimates is limited. For skin protection education, the results varied substantially across the trials, the effect was imprecise, and the pooled risk reduction was not large enough to be clinically important. The very low quality of the evidence means that we are unsure as to whether skin protection education reduces the risk of developing OIHD. The interventions probably cause few or no serious adverse effects.We conclude that at present there is insufficient evidence to confidently assess the effectiveness of interventions used in the primary prevention of OIHD. This does not necessarily mean that current measures are ineffective. Even though the update of this review included larger studies of reasonable quality, there is still a need for trials which apply standardised measures for the detection of OIHD in order to determine the effectiveness of the different prevention strategies.
Topics: Dermatitis, Irritant; Dermatitis, Occupational; Emollients; Excipients; Gloves, Protective; Hand Dermatoses; Humans; Organic Chemicals; Patient Education as Topic; Randomized Controlled Trials as Topic; Risk Reduction Behavior
PubMed: 29708265
DOI: 10.1002/14651858.CD004414.pub3