Uncontrolled Before-after Studies Research Articles

Targeted Drug Administration to Reduce Malaria Transmission: A Systematic Review and Meta-Analysis.

In low- to very low-malaria transmission areas, most infections may be accrued within specific groups whose behaviors or occupations put them at increased risk of infection. If these infections comprise a large proportion of the reservoir of infection, targeting interventions to these groups could reduce transmission at the population level. We conducted a systematic review to assess the impact of providing antimalarials to groups of individuals at increased risk of malaria whose infections were considered to comprise a large proportion of the local reservoir of infections (targeted drug administration [TDA]). A literature search was conducted in March 2021 and updated in April 2022. Two reviewers screened titles, abstracts, and full-text records. The Grading of Recommendations Assessment, Development and Evaluation approach was used to rate the certainty of the evidence (CoE) for each outcome. Out of 2,563 records, we identified five studies for inclusion: two cluster-randomized controlled trials (cRCTs) in Uganda and Kenya; one controlled before-after study in Ghana; and two uncontrolled before-after studies in Sri Lanka and Greece. Compared with no intervention, TDA resulted in little to no difference in the prevalence of infection at the population level (risk ratio [RR]: 0.85, 95% CI: 0.73-1.00; one cRCT, high CoE), although TDA likely resulted in a large reduction in prevalence among those targeted by the intervention (RR: 0.15, 95% CI: 0.06-0.38; two cRCTs, moderate CoE). Although TDA may reduce the burden of malaria among those receiving antimalarials, we found no evidence that it reduces transmission at the population level.

Mosquito aquatic habitat modification and manipulation interventions to control malaria.

Larval source management (LSM) may help reduce Plasmodium parasite transmission in malaria-endemic areas. LSM approaches include habitat modification (permanently or temporarily reducing mosquito breeding aquatic habitats); habitat manipulation (temporary or recurrent change to environment); or use of chemical (e.g. larviciding) or biological agents (e.g. natural predators) to breeding sites. We examined the effectiveness of habitat modification or manipulation (or both), with and without larviciding. This is an update of a review published in 2013. 1. To describe and summarize the interventions on mosquito aquatic habitat modification or mosquito aquatic habitat manipulation, or both, on malaria control. 2. To evaluate the beneficial and harmful effects of mosquito aquatic habitat modification or mosquito aquatic habitat manipulation, or both, on malaria control. We used standard, extensive Cochrane search methods. The latest search was from January 2012 to 30 November 2021. Randomized controlled trials (RCT) and non-randomized intervention studies comparing mosquito aquatic habitat modification or manipulation (or both) to no treatment or another active intervention. We also included uncontrolled before-after (BA) studies, but only described and summarized the interventions from studies with these designs. Primary outcomes were clinical malaria incidence, malaria parasite prevalence, and malaria parasitaemia incidence. We used standard Cochrane methods. We assessed risk of bias using the Cochrane RoB 2 tool for RCTs and the ROBINS-I tool for non-randomized intervention studies. We used a narrative synthesis approach to systematically describe and summarize all the interventions included within the review, categorized by the type of intervention (habitat modification, habitat manipulation, combination of habitat modification and manipulation). Our primary outcomes were 1. clinical malaria incidence; 2. malaria parasite prevalence; and 3. malaria parasitaemia incidence. Our secondary outcomes were 1. incidence of severe malaria; 2. anaemia prevalence; 3. mean haemoglobin levels; 4. mortality rate due to malaria; 5. hospital admissions for malaria; 6. density of immature mosquitoes; 7. density of adult mosquitoes; 8. sporozoite rate; 9. entomological inoculation rate; and 10. We used the GRADE approach to assess the certainty of the evidence for each type of intervention. Sixteen studies met the inclusion criteria. Six used an RCT design, six used a controlled before-after (CBA) study design, three used a non-randomized controlled design, and one used an uncontrolled BA study design. Eleven studies were conducted in Africa and five in Asia. Five studies reported epidemiological outcomes and 15 studies reported entomological outcomes. None of the included studies reported on the environmental impacts associated with the intervention. For risk of bias, all trials had some concerns and other designs ranging from moderate to critical. Ten studies assessed habitat manipulation (temporary change to the environment). This included water management (spillways across streams; floodgates; intermittent flooding; different drawdown rates of water; different flooding and draining regimens), shading management (shading of drainage channels with different plants), other/combined management approaches (minimal tillage; disturbance of aquatic habitats with grass clearing and water replenishment), which showed mixed results for entomological outcomes. Spillways across streams, faster drawdown rates of water, shading drainage canals with Napier grass, and using minimal tillage may reduce the density of immature mosquitoes (range of effects from 95% reduction to 1.7 times increase; low-certainty evidence), and spillways across streams may reduce densities of adult mosquitoes compared to no intervention (low-certainty evidence). However, the effect of habitat manipulation on malaria parasite prevalence and clinical malaria incidence is uncertain (very low-certainty evidence). Two studies assessed habitat manipulation with larviciding. This included reducing or removal of habitat sites; and drain cleaning, grass cutting, and minor repairs. It is uncertain whether drain cleaning, grass cutting, and minor repairs reduces malaria parasite prevalence compared to no intervention (odds ratio 0.59, 95% confidence interval (CI) 0.42 to 0.83; very low-certainty evidence). Two studies assessed combination of habitat manipulation and permanent change (habitat modification). This included drainage canals, filling, and planting of papyrus and other reeds for shading near dams; and drainage of canals, removal of debris, land levelling, and filling ditches. Studies did not report on epidemiological outcomes, but entomological outcomes suggest that such activities may reduce the density of adult mosquitoes compared to no intervention (relative risk reduction 0.49, 95% CI 0.47 to 0.50; low-certainty evidence), and preventing water stagnating using drainage of canals, removal of debris, land levelling, and filling ditches may reduce the density of immature mosquitoes compared to no intervention (ranged from 10% to 55% reductions; low-certainty evidence). Three studies assessed combining manipulation and modification with larviciding. This included filling or drainage of water bodies; filling, draining, or elimination of rain pools and puddles at water supply points and stream bed pools; and shoreline work, improvement and maintenance to drainage, clearing vegetation and undergrowth, and filling pools. There were mixed effect sizes for the reduction of entomological outcomes (moderate-certainty evidence). However, filling or draining water bodies probably makes little or no difference to malaria parasite prevalence, haemoglobin levels, or entomological inoculation rate when delivered with larviciding compared to no intervention (moderate-certainty evidence). Habitat modification and manipulation interventions for preventing malaria has some indication of benefit in both epidemiological and entomological outcomes. While the data are quite mixed and further studies could help improve the knowledge base, these varied approaches may be useful in some circumstances.

Perioperative care bundles for the prevention of surgical-site infections: meta-analysis.

Care bundles are used widely to prevent surgical-site infections (SSIs). Recent systematic reviews suggested larger effects from bundles with more interventions. These reviews were largely based on uncontrolled before-after studies and did not consider their biases. The aim of this meta-analysis was to determine the effectiveness of care bundles to prevent SSIs and explore characteristics of effective care bundles. A systematic review, reanalysis, and meta-analysis of available evidence were undertaken. RCTs, controlled before-after studies, and uncontrolled before-after studies with sufficient data for reanalysis as interrupted time series studies (ITS) were eligible. Studies investigating the use of a care bundle, with at least one intraoperative intervention, compared with standard care were included. Four RCTs, 1 controlled before-after study, and 13 ITS were included. Pooled data from RCTs were heterogeneous. Meta-analysis of ITS resulted in a level change of -1.16 (95 per cent c.i.-1.78 to -0.53), indicating a reduction in SSI. The effect was larger when the care bundle comprised a higher proportion of evidence-based interventions. Meta-regression analyses did not show statistically significant associations between effect estimates and number of interventions, number of evidence-based interventions, or proportion of evidence-based interventions. Meta-analysis of ITS indicated that perioperative care bundles prevent SSI. This effect is inconsistent across RCTs. Larger bundles were not associated with a larger effect, but the effect may be larger if the care bundle contains a high proportion of evidence-based interventions. No strong evidence for characteristics of effective care bundles was identified.

Efficacy of interventions to manage sexual dysfunction in women with cancer: a systematic review.

Cancer and its treatment negatively affect female sexual health and function. The prevalence of female sexual dysfunction after cancer is between 33% and 43%. Numerous studies have addressed treatment options for sexual dysfunction in women with cancer, but it still remains a challenge to select the most efficacious option for patients. To compile and appraise recent evidence of any interventions for managing sexual dysfunction in female cancer survivors. A literature search of the electronic databases MEDLINE, EMBASE, PsycINFO, and Cochrane Central Register of Controlled Trials (January 2011 to February 2021) was conducted using general search terms of "women", "cancer", "intervention", "sexual dysfunction". We included randomized controlled trials (RCTs) and uncontrolled before-after studies that evaluated the efficacy of intervention for female sexual dysfunction in women with history of cancer. Methodological quality of studies was assessed using Risk of Bias (RoB) 2.0 for RCTs and National Institutes of Health (NIH) assessment tools for uncontrolled before-after studies. Thirty-six studies were included for qualitative synthesis (14 RCTs (n = 1284), 17 uncontrolled trials (n = 589), and 5 cohort studies (n = 497). Only four studies were at low risk of bias. Topical interventions (vaginal gels or creams) were able to alleviate vaginal dryness and dyspareunia, with intravaginal dehydroepiandrosterone (DHEA) (6.5 mg) gel showing evidence of improved sexual function. Evidence for estriol-lactobacilli vaginal tablets was unreliable due to a small-scale study. Psychoeducational therapy (internet-based cognitive behavioral therapy [CBT]) studies typically were at high risk of bias, but all displayed significant improvements of sexual function. Both laser therapy (fractional CO2 and erbium) and multimodal approach studies were at concerning risk of bias, although suggesting beneficial effects on sexual function. The most reliable evidence for improvement was from a study of DHEA vaginal gel, but in general, gels or creams were useful in reducing dyspareunia. Pharmacological, psychoeducational, laser therapy, and multimodal approaches demonstrated potential in managing cancer-related sexual issues, but most were small in size (10-70 participants), with moderate to high risk of bias. Therefore, large-scale, double-blind, RCTs with long-period follow-up, and at low risk of bias are needed to show efficacy for these interventions.

A critical review of methodologies used in pharmaceutical pricing policy analyses

Robust evidence from health policy research has the potential to inform policy-making, but studies have suggested that methodological shortcomings are abundant. We aimed to identify common methodological weaknesses in pharmaceutical pricing policy analyses. A systematic review (SR) of studies examining pharmaceutical pricing policies served as basis for the present analysis. We selected all studies that were included in the SR (n = 56), and those that were excluded from the SR due to ineligible study designs only (n = 101). Risk of bias was assessed and specific study design issues were recorded to identify recurrent methodological issues. Sixty-one percent of studies with a study design eligible for the SR presented with a high risk of bias in at least one domain. Potential interference of co-interventions was a source of possible bias in 53% of interrupted time series studies. Failing to consider potential confounders was the primary cause for potential bias in difference-in-differences, regression, and panel data analyses. In 101 studies with a study design not eligible for the SR, 32% were uncontrolled before-after studies and 23% were studies without pre-intervention data. Some of the methodological issues encountered may be resolved during the design of a study. Awareness among researchers on methodological issues will help improve the rigor of health policy research in general.

Medication-related interventions to improve medication safety and patient outcomes on transition from adult intensive care settings: a systematic review and meta-analysis

BackgroundPatients recovering from an episode in an intensive care unit (ICU) frequently experience medication errors on transition to the hospital ward. Structured handover recommendations often underestimate the challenges and complexity...

Oral appliance-generated malocclusion traits during the long-term management of obstructive sleep apnea in adults.

To identify malocclusion characteristics generated after using oral appliances (OAs) for at least 5 years for the management of snoring and obstructive sleep apnea (OSA) in adults. PubMed, MEDLINE (Ovid), Scopus, CINAHL, and Informit were searched without language restrictions through January 20, 2021. Unpublished literature was searched on ClinicalTrials.gov, the National Research Register, and the Pro-Quest Dissertation Abstracts and Thesis database. Authors were contacted when necessary, and reference lists of the included studies were screened. Risk of bias was assessed through the revised Cochrane Risk of Bias tool for randomized controlled trials (RoB2) and Non-Randomized Studies of Interventions for non-RCTs and uncontrolled before-after studies (ROBINS-I). A random-effects meta-analysis was conducted only on studies that used the same OAs to exclude biomechanical differences. Risk of bias across studies was assessed with the Grading of Recommendations, Assessment, Development and Evaluation tool. A total of 12 studies were included in the final qualitative synthesis. Eight included studies had high, one had moderate, and three had low risks of bias. Significant progressive decreases of overjet (OJ; -1.43 mm; 95% confidence interval [CI], -1.66 to -1.20) and overbite (OB; -1.94 mm; 95% CI, -2.14 to -1.74) associated with maxillary incisor retroclination and mandibular incisor proclination were reported long term. Although most studies showed no sagittal skeletal changes, some degree of vertical skeletal changes were noted. Based on a very low evidence level, inevitable anterior teeth positional changes seem to be a common long-term adverse effect of OAs. The magnitude of those changes could be considered clinically irrelevant for most pretreatment occlusions, but in occlusions with limited OJ and OB, it may be worth clinical consideration.

Can SBAR be implemented with high fidelity and does it improve communication between healthcare workers? A systematic review

ObjectiveTo characterise the extent to which health professionals perform SBAR (situation, background, assessment, recommendation) as intended (ie, with high fidelity) and the extent to which its use improves communication clarity...

Optimal designs of clinical studies in the context of their inclusion in systematic reviews.

In this article I focus on the designs of clinical studies that have a high likelihood of producing reliable findings and those that do not, but that are still being published in large numbers in scientific journals. The former category includes randomized trials, controlled before-after studies and interrupted time series, while the latter category comprises non-randomized trials, uncontrolled before-after studies, case-control/cohort studies and other observational studies. This distinction is important, particularly when studies of inferior design are used in systematic reviews that inform clinical practice guidelines, thereby potentially exerting adverse effects on clinical practice. I also highlight the implications of failing to enrol adequate numbers of patients in clinical trials.

Nutritional intervention strategies for the management of overweight and obesity in primary health care: A systematic review with meta-analysis.

A systematic review with meta-analysis (MA) was conducted to synthesize the effectiveness of nutrition intervention strategies for managing overweight and obesity in the adult population attending primary health care. Relevant articles were searched in the PubMed, Embase, Web of Science, Cochrane and LILACS databases from inception to January 2020. Seventy studies were identified: 45 randomized controlled trials (RCTs) and 25 uncontrolled before-after studies (UBAs). The MA of nutritional intervention revealed a reduced average estimate of the effect on weight in RCTs (weighted mean differences [WMD]=-1.80kg, 95% confidence interval [CI], -2.40 to -1.19), BMI (WMD=-0.80kg/m2 , 95% CI, -1.11 to -0.49), and WC (WMD=-2.28cm, 95% CI, -3.06 to -1.49); and for UBAs showed reductions in weight (WMD=-4.17kg; 95% CI, -5.18 to -1.70), BMI (WMD=-1.26kg/m2 ; 95% CI, -1.81 to -0.72) and (WMD=-2.90cm; 95%CI, -4.21 to -1.59). There was no association between treatment effect and follow-up for both designs. Nutritional interventions alone yielded a higher but nonsignificant average reduction on weight when compared with combined components intervention. Interventions delivered through individual or group sessions showed a similar positive effect on weight decrease. The dietary prescription approach yielded a greater effect on weight loss than did the behavioural approaches but only in UBA studies.

Educational interventions for preventing lead poisoning in workers

Occupational lead exposure can lead to serious health effects that range from general symptoms (depression, generalised ache, and digestive signs, such as loss of appetite, stomach ache, nausea, diarrhoea, and constipation) to chronic conditions (cerebrovascular and cardiovascular diseases, cognitive impairment, kidney disease, cancers, and infertility). Educational interventions may contribute to the prevention of lead uptake in workers exposed to lead, and it is important to assess their effectiveness. To assess the effect of educational interventions for preventing lead uptake in workers exposed to lead. We searched CENTRAL, MEDLINE, Embase, CINAHL, and OSH UPDATE to 5 June 2020, with no language restrictions. We sought randomised controlled trials (RCT), cluster-RCTs (cRCT), interrupted time series (ITS), controlled before-after studies (CBA) and uncontrolled before-after studies that examined the effects of an educational intervention aimed at preventing lead exposure and poisoning in workers who worked with lead, for which effectiveness was measured by lead levels in blood and urine, blood zinc protoporphyrin levels and urine aminolevulinic acid levels. Two review authors independently screened the search results, assessed studies for eligibility, and extracted data using standard Cochrane methods. We used the ROBINS-I tool to assess the risk of bias, and GRADE methodology to assess the certainty of the evidence. We did not find any RCT, cRCT, ITS or CBA studies that met our criteria. We included four uncontrolled before-after studies studies, conducted between 1982 and 2004. Blood lead levels Educational interventions may reduce blood lead levels, but the evidence is very uncertain. In the short-term after the educational intervention, blood lead levels may decrease (mean difference (MD) 9.17 µg/dL, 95% confidence interval (CI) 4.14 to 14.20; one study with high baseline blood lead level, 18 participants; very low-certainty evidence). In the medium-term, blood lead levels may decrease (MD 3.80 µg/dL, 95% CI 1.48 to 6.12; one study with high baseline blood lead level, 34 participants; very low-certainty evidence). In the long-term, blood lead levels may decrease when the baseline blood lead levels are high (MD 8.08 µg/dL; 95% CI 3.67 to 12.49; two studies, 69 participants; very low-certainty evidence), but not when the baseline blood lead levels are low (MD 1.10 µg/dL, 95% CI -0.11 to 2.31; one study, 52 participants, very low-certainty evidence). Urine lead levels In the long-term, urinary lead levels may decrease after the educational intervention, but the evidence is very uncertain (MD 42.43 µg/L, 95% CI 29.73 to 55.13; one study, 35 participants; very low-certainty evidence). Behaviour change The evidence is very uncertain about the effect of educational intervention on behaviour change. At medium-term follow-up after the educational intervention, very low-certainty evidence from one study (89 participants) found inconclusive results for washing before eating (risk ratio (RR) 1.71, 95% CI 0.42 to 6.91), washing before drinking (RR 1.37, 95% CI 0.61 to 3.06), and not smoking in the work area (RR 1.04, 95% CI 0.74 to 1.46). Very low-certainty evidence from one study (21 participants) suggested that employers may improve the provision of fit testing for all respirator users (RR 1.87, 95% CI 1.16 to 3.01), and prohibit eating, drinking, smoking, and other tobacco use in the work area (RR 4.25, 95% CI 1.72 to 10.51), however, the results were inconclusive for the adequate provision of protective clothing (RR 1.40, 95% CI 0.82 to 2.40). At long-term follow-up, very low-certainty evidence from one study (89 participants) suggested that workers may improve washing before drinking (RR 3.24, 95% CI 1.09 to 9.61), but results were inconclusive for washing before eating (RR 11.71, 95% CI 0.66 to 208.33), and for not smoking in the work area (RR 1.56, 95% CI 0.98 to 2.50). Very low-certainty evidence from one study (21 participants) suggested that employers may improve the provision of fit testing for all respirator users (RR 1.70, 95% CI 1.09 to 2.63), may provide adequate protective clothing (RR 2.80, 95% CI 1.23 to 6.37), and may prohibit eating, drinking, smoking, and other tobacco use in the work area (RR 2.13, 95% CI 1.19 to 3.81). Improved knowledge or awareness of the adverse health effects of lead The evidence is very uncertain about the effect of educational intervention on workers' knowledge. At medium-term follow-up, questionnaires found that workers' knowledge may improve (MD 5.20, 95% CI 3.29 to 7.11; one study, 34 participants; very low-certainty evidence). At long-term follow-up, there may be an improvement in workers' knowledge (MD 5.80, 95% CI 3.89 to 7.71; one study, 34 participants; very low-certainty evidence), but results were inconclusive for employers' knowledge (RR 1.67, 95% CI 0.74 to 3.75; one study, 21 participants; very low-certainty evidence). None of the studies measured the other outcomes of interest: blood zinc protoporphyrin levels, urine aminolevulinic acid levels, air lead levels, and harms. One study provided the costs of each component of the intervention. Educational interventions may prevent lead poisoning in workers with high baseline blood lead levels and urine lead levels but this is uncertain. Educational interventions may not prevent lead poisoning in workers with low baseline blood lead levels but this is uncertain.

The effects of diagnosis-related groups payment on hospital healthcare in China: a systematic review

BackgroundThere has been a growing interest in using diagnosis-related groups (DRGs) payment to reimburse inpatient care worldwide. But its effects on healthcare and health outcomes are controversial, and the evidence from low- and middle- income countries (LMICs) is especially scarce. The objective of this study is to evaluate the effects of DRGs payment on healthcare and health outcomes in China.MethodA systematic review was conducted. We searched literature databases of PubMed, Cochrane Library, EMBASE, Web of Science, Chinese National Knowledge Infrastructure and SinoMed for empirical studies examining the effects of DRGs payment on healthcare in mainland China. We performed a narrative synthesis of outcomes regarding expenditure, efficiency, quality and equity of healthcare, and assessed the quality of evidence.ResultsTwenty-three publications representing thirteen DRGs payment studies were included, including six controlled before after studies, two interrupted time series studies and five uncontrolled before-after studies. All studies compared DRGs payment to fee-for-service, with or without an overall budget, in settings of tertiary (7), secondary (7) and primary care (1). The involved participants varied from specific groups to all inpatients. DRGs payment mildly reduced the length of stay. Impairment of equity of healthcare was consistently reported, especially for patients exempted from DRGs payment, including: patient selection, cost-shifting and inferior quality of healthcare. However, findings on total expenditure, out of pocket payment (OOP) and quality of healthcare were inconsistent. The quality of the evidence was generally low or very low due to the study design and potential risk of bias of included studies.ConclusionDRGs payment may mildly improve the efficiency but impair the equity and quality of healthcare, especially for patients exempted from this payment scheme, and may cause up-coding of medical records. However, DRGs payment may or may not contain the total expenditure or OOP, depending on the components design of the payment. Policymakers should very carefully consider each component of DRGs payment design against policy goals. Well-designed randomised trials or comparative studies are warranted to consolidate the evidence of the effects of DRGs payment on healthcare and health outcomes in LMICs to inform policymaking.

Spotlight on Transition in Patients With Inflammatory Bowel Disease: A Systematic Review.

Transition of adolescents from pediatric to adult care is of great importance in the management of inflammatory bowel disease (IBD). Our aim was to review and summarize the currently applied interventions and outcomes related to transition practices in IBD. A systematic review was performed in accordance with the PRISMA Statement. We searched PubMed, EMBASE, CENTRAL, and Web of Science databases up to February 15, 2019. Controlled studies evaluating adolescents and young adults with IBD participating in structured transition interventions or patient educational programs and single-arm (before-after) studies were included. Several individual, health care, and social outcomes were assessed. The PROSPERO registration number is CRD42019118520. A total of 23 articles were eligible for qualitative synthesis. Eleven studies compared an intervention to a control group, whilst 12 studies were uncontrolled before-after studies. The age of the participants varied from 11 to 25 years. The most common structured transition interventions were joint visits and patient education programs. IBD nurses were operating as nominated transition coordinators in the transition process. Quality of life, patient satisfaction, self-efficacy, disease-specific knowledge, adherence rate, and nonattendance rate at outpatient clinic were identified as main health care transition outcomes besides disease-related outcomes. Despite the various study designs and methodological limitations, outcomes improved with the application of structured transition interventions in eleven of the studies. These results facilitate the design of randomized controlled trials along better standards in transitional care in IBD.

Interventions to improve insulin prescribing practice for people with diabetes in hospital: a systematic review.

To conduct a systematic review of literature to identify interventions that are effective in improving insulin prescribing for people with diabetes in the hospital setting. Computerized bibliographic databases were searched for studies published in English that described the effectiveness of interventions to improve insulin prescribing within the hospital setting. Studies were eligible for inclusion if they reported data that compared insulin prescribing practice after an intervention or compared with a control group. Studies were not excluded on the basis of publication date, geographical location or risk of bias assessment. We identified 35 studies for inclusion in the review, including two cluster randomized controlled trials, two cohort studies, and 31 uncontrolled before-after studies. Studies reported a variety of interventions that aimed to increase insulin prescribing accuracy or completeness or decrease the use of discouraged subcutaneous sliding scale insulin regimens. Differences in definition of insulin prescribing error, terminology and common practice based on geographical location was evident, and quality issues with respect to study design and reporting somewhat limited the interpretation of conclusions. Implementing strategies that are sensitive to local context and designed to increase adherence to insulin prescribing guidelines are associated with a reduction in prescribing errors. Future implementation should build on effective approaches including multifaceted interventions involving multiple stakeholders at various institutional levels. Future studies in insulin prescribing errors would benefit from the use of standardized approaches, terminology and outcome measures to enable greater comparison.

Interventions to reduce ambient particulate matter air pollution and their effect on health.

Ambient air pollution is associated with a large burden of disease in both high-income countries (HICs) and low- and middle-income countries (LMICs). To date, no systematic review has assessed the effectiveness of interventions aiming to reduce ambient air pollution. To assess the effectiveness of interventions to reduce ambient particulate matter air pollution in reducing pollutant concentrations and improving associated health outcomes. We searched a range of electronic databases with diverse focuses, including health and biomedical research (CENTRAL, Cochrane Public Health Group Specialised Register, MEDLINE, Embase, PsycINFO), multidisciplinary research (Scopus, Science Citation Index), social sciences (Social Science Citation Index), urban planning and environment (Greenfile), and LMICs (Global Health Library regional indexes, WHOLIS). Additionally, we searched grey literature databases, multiple online trial registries, references of included studies and the contents of relevant journals in an attempt to identify unpublished and ongoing studies, and studies not identified by our search strategy. The final search date for all databases was 31 August 2016. Eligible for inclusion were randomized and cluster randomized controlled trials, as well as several non-randomized study designs, including controlled interrupted time-series studies (cITS-EPOC), interrupted time-series studies adhering to EPOC standards (ITS-EPOC), interrupted time-series studies not adhering to EPOC standards (ITS), controlled before-after studies adhering to EPOC standards (CBA-EPOC), and controlled before-after studies not adhering to EPOC standards (CBA); these were classified as main studies. Additionally, we included uncontrolled before-after studies (UBA) as supporting studies. We included studies that evaluated interventions to reduce ambient air pollution from industrial, residential, vehicular and multiple sources, with respect to their effect on mortality, morbidity and several air pollutant concentrations. We did not restrict studies based on the population, setting or comparison. After a calibration exercise among the author team, two authors independently assessed studies for inclusion, extracted data and assessed risk of bias. We conducted data extraction, risk of bias assessment and evidence synthesis only for main studies; we mapped supporting studies with regard to the types of intervention and setting. To assess risk of bias, we used the Graphic Appraisal Tool for Epidemiological studies (GATE) for correlation studies, as modified and employed by the Centre for Public Health Excellence at the UK National Institute for Health and Care Excellence (NICE). For each intervention category, i.e. those targeting industrial, residential, vehicular and multiple sources, we synthesized evidence narratively, as well as graphically using harvest plots. We included 42 main studies assessing 38 unique interventions. These were heterogeneous with respect to setting; interventions were implemented in countries across the world, but most (79%) were implemented in HICs, with the remaining scattered across LMICs. Most interventions (76%) were implemented in urban or community settings.We identified a heterogeneous mix of interventions, including those aiming to address industrial (n = 5), residential (n = 7), vehicular (n = 22), and multiple sources (n = 4). Some specific interventions, such as low emission zones and stove exchanges, were assessed by several studies, whereas others, such as a wood burning ban, were only assessed by a single study.Most studies assessing health and air quality outcomes used routine monitoring data. Studies assessing health outcomes mostly investigated effects in the general population, while few studies assessed specific subgroups such as infants, children and the elderly. No identified studies assessed unintended or adverse effects.The judgements regarding the risk of bias of studies were mixed. Regarding health outcomes, we appraised eight studies (47%) as having no substantial risk of bias concerns, five studies (29%) as having some risk of bias concerns, and four studies (24%) as having serious risk of bias concerns. Regarding air quality outcomes, we judged 11 studies (31%) as having no substantial risk of bias concerns, 16 studies (46%) as having some risk of bias concerns, and eight studies (23%) as having serious risk of bias concerns.The evidence base, comprising non-randomized studies only, was of low or very low certainty for all intervention categories and primary outcomes. The narrative and graphical synthesis showed that evidence for effectiveness was mixed across the four intervention categories. For interventions targeting industrial, residential and multiple sources, a similar pattern emerged for both health and air quality outcomes, with essentially all studies observing either no clear association in either direction or a significant association favouring the intervention. The evidence base for interventions targeting vehicular sources was more heterogeneous, as a small number of studies did observe a significant association favouring the control. Overall, however, the evidence suggests that the assessed interventions do not worsen air quality or health. Given the heterogeneity across interventions, outcomes, and methods, it was difficult to derive overall conclusions regarding the effectiveness of interventions in terms of improved air quality or health. Most included studies observed either no significant association in either direction or an association favouring the intervention, with little evidence that the assessed interventions might be harmful. The evidence base highlights the challenges related to establishing a causal relationship between specific air pollution interventions and outcomes. In light of these challenges, the results on effectiveness should be interpreted with caution; it is important to emphasize that lack of evidence of an association is not equivalent to evidence of no association.We identified limited evidence for several world regions, notably Africa, the Middle East, Eastern Europe, Central Asia and Southeast Asia; decision-makers should prioritize the development and implementation of interventions in these settings. In the future, as new policies are introduced, decision-makers should consider a built-in evaluation component, which could facilitate more systematic and comprehensive evaluations. These could assess effectiveness, but also aspects of feasibility, fidelity and acceptability.The production of higher quality and more uniform evidence would be helpful in informing decisions. Researchers should strive to sufficiently account for confounding, assess the impact of methodological decisions through the conduct and communication of sensitivity analyses, and improve the reporting of methods, and other aspects of the study, most importantly the description of the intervention and the context in which it is implemented.

Validity and effectiveness of paediatric early warning systems and track and trigger tools for identifying and reducing clinical deterioration in hospitalised children: a systematic review

ObjectiveTo assess (1) how well validated existing paediatric track and trigger tools (PTTT) are for predicting adverse outcomes in hospitalised children, and (2) how effective broader paediatric early warning systems...

Efficacy of biofeedback therapy on sleep bruxism: A systematic review and meta-analysis.

This study updates the review published by Wang etal in 2014 (Sleep Breath 2014;18(2):235-242). The review focuses on the most recent literature on management of sleep bruxism (SB) with biofeedback. An electronic search was conducted in five databases searching for articles published later than the date of Wang etal's search, viz., October 2012. Six articles of 2320 identified citations involving 86 adult participants were included in the qualitative synthesis. Of them, 4 were randomised controlled trials (RCTs) and 2 were uncontrolled before-after studies. Different feedback modalities (electrical, auditory and vibratory stimulus) were investigated. The overall quality of the selected studies was assessed using the GRADE criteria. Due to heterogeneity between studies, the quantitative synthesis was performed out of three RCTs, of which two were retrieved from the previous review. The meta-analysis indicated a non-significant difference in electromyographic-measured SB episodes per hour after one night of contingent electrical stimulation (CES) compared with placebo control, yet a significant difference was shown after five nights of CES. The quality of evidence identified through GRADEpro was from low to moderate, due to imprecision and inconsistency between studies. Qualitative synthesis did not present a reliable reduction in clinical pain levels; however, no substantial sleep disturbances were indicated following the intervention. In conclusion, one of the biofeedback modalities, CES, is effective in reducing SB-related motor activities after a short-term treatment period. However, evidence of long-term effects is lacking. Further longitudinal studies with larger samples are necessary to acknowledge the clinical application of biofeedback.

Closed-system drug-transfer devices plus safe handling of hazardous drugs versus safe handling alone for reducing exposure to infusional hazardous drugs in healthcare staff.

Occupational exposure to hazardous drugs can decrease fertility and result in miscarriages, stillbirths, and cancers in healthcare staff. Several recommended practices aim to reduce this exposure, including protective clothing, gloves, and biological safety cabinets ('safe handling'). There is significant uncertainty as to whether using closed-system drug-transfer devices (CSTD) in addition to safe handling decreases the contamination and risk of staff exposure to infusional hazardous drugs compared to safe handling alone. To assess the effects of closed-system drug-transfer of infusional hazardous drugs plus safe handling versus safe handling alone for reducing staff exposure to infusional hazardous drugs and risk of staff contamination. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, OSH-UPDATE, CINAHL, Science Citation Index Expanded, economic evaluation databases, the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov to October 2017. We included comparative studies of any study design (irrespective of language, blinding, or publication status) that compared CSTD plus safe handling versus safe handling alone for infusional hazardous drugs. Two review authors independently identified trials and extracted data. We calculated the risk ratio (RR) and mean difference (MD) with 95% confidence intervals (CI) using both fixed-effect and random-effects models. We assessed risk of bias according to the risk of bias in non-randomised studies of interventions (ROBINS-I) tool, used an intracluster correlation coefficient of 0.10, and we assessed the quality of the evidence using GRADE. We included 23 observational cluster studies (358 hospitals) in this review. We did not find any randomised controlled trials or formal economic evaluations. In 21 studies, the people who used the intervention (CSTD plus safe handling) and control (safe handling alone) were pharmacists or pharmacy technicians; in the other two studies, the people who used the intervention and control were nurses, pharmacists, or pharmacy technicians. The CSTD used in the studies were PhaSeal (13 studies), Tevadaptor (1 study), SpikeSwan (1 study), PhaSeal and Tevadaptor (1 study), varied (5 studies), and not stated (2 studies). The studies' descriptions of the control groups were varied. Twenty-one studies provide data on one or more outcomes for this systematic review. All the studies are at serious risk of bias. The quality of evidence is very low for all the outcomes.There is no evidence of differences in the proportion of people with positive urine tests for exposure between the CSTD and control groups for cyclophosphamide alone (RR 0.83, 95% CI 0.46 to 1.52; I² = 12%; 2 studies; 2 hospitals; 20 participants; CSTD: 76.1% versus control: 91.7%); cyclophosphamide or ifosfamide (RR 0.09, 95% CI 0.00 to 2.79; 1 study; 1 hospital; 14 participants; CSTD: 6.4% versus control: 71.4%); and cyclophosphamide, ifosfamide, or gemcitabine (RR not estimable; 1 study; 1 hospital; 36 participants; 0% in both groups).There is no evidence of a difference in the proportion of surface samples contaminated in the pharmacy areas or patient-care areas for any of the drugs except 5-fluorouracil, which was lower in the CSTD group than in the control (RR 0.65, 95% CI 0.43 to 0.97; 3 studies, 106 hospitals, 1008 samples; CSTD: 9% versus control: 13.9%).The amount of cyclophosphamide was lower in pharmacy areas in the CSTD group than in the control group (MD -49.34 pg/cm², 95% CI -84.11 to -14.56, I² = 0%, 7 studies; 282 hospitals, 1793 surface samples). Additionally, one interrupted time-series study (3 hospitals; 342 samples) demonstrated a change in the slope between pre-CSTD and CSTD (3.9439 pg/cm², 95% CI 1.2303 to 6.6576; P = 0.010), but not between CSTD and post-CSTD withdrawal (-1.9331 pg/cm², 95% CI -5.1260 to 1.2598; P = 0.20). There is no evidence of difference in the amount of the other drugs between CSTD and control groups in the pharmacy areas or patient-care areas.None of the studies report on atmospheric contamination, blood tests, or other measures of exposure to infusional hazardous drugs such as urine mutagenicity, chromosomal aberrations, sister chromatid exchanges, or micronuclei induction.None of the studies report short-term health benefits such as reduction in skin rashes, medium-term reproductive health benefits such as fertility and parity, or long-term health benefits related to the development of any type of cancer or adverse events.Five studies (six hospitals) report the potential cost savings through the use of CSTD. The studies used different methods of calculating the costs, and the results were not reported in a format that could be pooled via meta-analysis. There is significant variability between the studies in terms of whether CSTD resulted in cost savings (the point estimates of the average potential cost savings ranged from (2017) USD -642,656 to (2017) USD 221,818). There is currently no evidence to support or refute the routine use of closed-system drug transfer devices in addition to safe handling of infusional hazardous drugs, as there is no evidence of differences in exposure or financial benefits between CSTD plus safe handling versus safe handling alone (very low-quality evidence). None of the studies report health benefits.Well-designed multicentre randomised controlled trials may be feasible depending upon the proportion of people with exposure. The next best study design is interrupted time-series. This design is likely to provide a better estimate than uncontrolled before-after studies or cross-sectional studies. Future studies may involve other alternate ways of reducing exposure in addition to safe handling as one intervention group in a multi-arm parallel design or factorial design trial. Future studies should have designs that decrease the risk of bias and enable measurement of direct health benefits in addition to exposure. Studies using exposure should be tested for a relevant selection of hazardous drugs used in the hospital to provide an estimate of the exposure and health benefits of using CSTD. Steps should be undertaken to ensure that there are no other differences between CSTD and control groups, so that one can obtain a reasonable estimate of the health benefits of using CSTD.

29 Has the licensing ACT 2003 affected levels of violence in England and Wales? A systematic review of hospital and police studies

BackgroundPopulation-level legislation has been implemented in many countries to try and address alcohol misuse and related harms, including assault. Most violent incidents in the UK are alcohol-related, with alcohol misuse...

Oral appliances for managing sleep bruxism in adults: a systematic review from 2007 to 2017.

The review focuses on the last decade of research regarding the use of various oral appliances (OAs) in the management of sleep bruxism (SB) in adults. Sixteen (n = 16) papers of 641 identified citations involving 398 participants were included in the review. Of them, seven were randomised controlled trials (RCTs), seven were uncontrolled before-after studies and two were crossover trials. Analysis of the included articles revealed a high variability of study designs and findings. Generally, the risk of bias was low-to-unclear for RCTs and high for crossover studies, whilst the before-after studies exhibited several structural limitations. Nine studies used polysomnography/polygraphy/electromyography for SB diagnosis, whilst others were based on history taking and clinical examination. Most of them featured small samples and were short term. Of the studies using objective SB evaluations, eight showed positive results for almost every type of OA in reducing SB activity, with a higher decrease for devices that are designed to provide a certain extent of mandibular advancement. Among the studies using a subjective SB evaluation, one demonstrated a significant reduction in SB activity, and additional two showed a myorelaxant effect of OA in SB patients. Although many positive studies support the efficiency of OA treatment for SB, accepted evidence is insufficient to support its role in the long-term reduction of SB activity. Further studies with larger samples and sufficient treatment periods are needed to obtain more acknowledgements for clinical application.