Quality Of Observational Studies Research Articles

Using STROBE checklist to assess the reporting quality of observational studies affiliated with Shiraz University of Medical Sciences, and its correlates: a scientometric study from Iran

The reporting quality of Observational Studies (OSs) is an important measure of their overall quality. We aim to assess the reporting quality of OSs of Shiraz University of Medical Sciences (SUMS) in Iran in the years 2012–2015, using Strengthening the Reporting of Observational Studies checklist. Systematic online search was performed. A random sample of SUMS affiliated published articles was selected. Articles were appraised and scored by two reviewers. Variables such as the study design, publication year, journals’ impact factor etc. were retrieved and their correlation with the articles’ scores was assessed. Out of 4297 published articles during 2012–2015, 1742 (40.5%) were OSs of which we assessed 171 (~ 10%) studies. Among these, 87 (50.9%), 74 (43.3%) and 10 (5.8%) articles had a cross-sectional, case–control and cohort design, respectively. Overall score of the reporting quality was 79% ± 0.01. It was at 81% ± 0.1, 77% ± 0.01 and 83% ± 0.02 for cross-sectional, case–control and cohort studies, respectively. A significant correlation was observed between the study design and the score for the reporting quality (P = 0.015). Reporting of “flow-diagram” (5%), “sources of bias” (28%) and “study size calculation” (30%) were the most missed items. Although the overall reporting quality of OSs was found to be at an acceptable rate, there are points of concern regarding some of the most important items that deserve the attention of authors as well as reviewers and editors.

Protocol for a systematic review of the development of depression among adolescents and young adults: psychological, biological, and contextual perspectives around the world

BackgroundDepression is a leading contributor to disability-adjusted life-years because of early onset and chronicity throughout the lifecycle. It is crucial to identify early predictors of depression among adolescents and young people to effectively target prevention. A gap in the literature is a comprehensive systematic review of predictors of depression among adolescents around the globe, especially in low- and middle-income countries LMICs. This review aims to identify evidence for biological, psychological, and contextual risk factors for the development of depression among adolescents and young adults (10–24 years of age) in high-income countries (HICs) and LMICs, ultimately contributing to (a) identification of potential mechanisms underlying depression development, (b) selection of common risk and protective factors as targets for detection, and (c) refinement of risk models that can be evaluated through existing cohorts in HICs and LMICs.MethodsThis review will follow the Population, Exposure, Comparison, Outcome (PI(E)CO) model and adheres to the PRISMA-P guidelines. A search strategy was developed by a multidisciplinary research consortium. Seven databases (MEDLINE via Ovid, PsycINFO, Cochrane Database of Systematic Reviews, Web of Science, Lilacs, African Journals Online, Global Health) will be searched to identify articles. Independent raters will screen and retrieve articles for inclusion, conduct quality ratings, and extract data. The Systematic Assessment of Quality in Observational Research adapted for Cultural Psychiatry Epidemiology (SAQOR-CPE) will be used to assess quality of observational studies. We will assess for publication bias using funnel plots and statistical methods. We will use narrative synthesis to present results, addressing the study’s objectives following the Cochrane Handbook guidelines. Meta-analyses will be used to report summary statistics for association of risk factors with development of depression.DiscussionThis systematic review will summarize evidence-based research that examines the psychological, biological, and contextual factors contributing to the onset of depression in adolescents across the globe. Results will support the development of a model that can be evaluated in existing cohorts around the world.Systematic review registrationPROSPERO registration CRD42018103973.

Sexual dysfunction and related factors in pregnancy and postpartum: a systematic review and meta-analysis protocol

BackgroundSexual dysfunction refers to a chain of psychiatric, individual, and couple’s experiences that manifests itself as a dysfunction in sexual desire, sexual arousal, orgasm, and pain during intercourse. The aim of this systematic review will be to assess the sexual dysfunction and determine the relevant factors to sexual dysfunction during pregnancy and postpartum.Methods and analysisAll observational studies, including descriptive, descriptive-analytic, case-control, and cohort studies published between 1990 and 2019, will be included in the study. Review articles, case studies, case reports, letter to editors, pilot studies, and editorial will be excluded from the study. The search will be conducted in the Cochrane Central Register, MEDLINE, Google Scholar, EMBASE, ProQuest, Scopus, WOS, and CINAHL databases. Eligible studies should assess at least one of the sexual dysfunction symptoms in pregnant women or in the first year postpartum. Quality assessment of studies will be performed by two authors independently based on the NOS checklist. This checklist is designed to assess the quality of observational studies. Data will be analyzed using Stata software ver. 11. Considering that the index investigated in the present study will be the level of sexual disorder, standard error will be calculated for each study using binomial distribution. The heterogeneity level will be investigated using Cochran’s Q statistic and I2 index in a chi-square test at a significance level of 1.1. Predictable limitations of this study included a small number and unacceptable quality of studies.DiscussionThis systematic review addresses the factors associated with sexual dysfunction during pregnancy and postpartum. Considering the high prevalence of sexual dysfunction among women, the treatment of this problem has been highly sought after by the World Health Organization in recent years. The results of this study can help discover new strategies by introducing factors affecting women’s sexual dysfunction, thereby eliminating or diminishing these factors, and play an important role in improving the quality of life of women during pregnancy and postpartum periods.Systematic review registrationPROSPERO CRD42018083554

Assessing the safety of beta-blocker therapy in cirrhosis patients with ascites: A meta-analysis.

Beta-blocker therapy is effective at reducing risks of variceal bleeding. However, beta-blockers may detrimentally exacerbate the underlying haemodynamic changes in cirrhosis. A systematic review and meta-analysis was performed to evaluate impact of beta-blockers on all-cause mortality among cirrhosis patients with ascites. A literature search identified studies that evaluated beta-blocker vs no beta-blocker therapy in cirrhosis patients with ascites. The primary outcome was all-cause mortality with subcohort analysis of patients with refractory or severe ascites. Quality of observational studies was assessed with Newcastle-Ottawa Scale and overall certainty of the evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. Eight observational studies, representing 3627 cirrhosis patients with ascites (1630 treated with beta-blockers and 1997 not treated), were included. Pooled all-cause mortality was 38.6% in beta-blocker group vs 42.2% in no beta-blocker group (RR 0.93, 95% CI 0.77-1.13, χ2 =54.03, I2 =87%). Subcohort analysis of cirrhosis patients with refractory or severe ascites demonstrated 33.3% mortality in beta-blocker group vs 32.1% in no beta-blocker group (RR 0.99, 95% CI 0.70-1.40, χ2 =32.99, and I2 =82%). Three studies were good quality and five studies were fair quality. GRADE rating was 'very low' certainty of evidence, given concern for bias and inconsistency stemming from significant heterogeneity. No significant increase in all-cause mortality was observed in cirrhosis patients with ascites treated with beta-blockers. However, given the low certainty of the evidence, high quality prospective studies are needed.

Combined Laparoscopic Uterine Artery Occlusion and Myomectomy versus Laparoscopic Myomectomy: A Direct-Comparison Meta-Analysis of Short- and Long-Term Outcomes in Women with Symptomatic Leiomyomas

ObjectiveTo ascertain the efficacy and safety of laparoscopic uterine artery occlusion (LUAO) during laparoscopic myomectomy (LM) on intra- and postoperative morbidity and to assess its impact on leiomyoma recurrence rates. Data SourcesMEDLINE, Scopus, Web of Science, and Cochrane Database were searched for relevant references from inception until December 2018, in line with PRISMA guidelines. Methods of Study SelectionTwo authors screened for study eligibility and extracted data. Randomized controlled trials (RCTs) and observational studies (OSs) comparing short- and long-term morbidity of LM with or without LUAO were included. The modified Jadad score and the methodologic index for nonrandomized studies were used to evaluate the quality of RCTs and OSs, respectively. Tabulation, Integration, and ResultsTwelve studies encompassing 750 LM and 873 LUAO-LM cases were included in the meta-analysis. The studies were of moderate quality. LUAO-LM appears to significantly decrease intraoperative blood loss, postoperative hemoglobin drop, and blood transfusion rate. A trend toward shorter hospital length of stay was demonstrated, whereas no significant difference in operation duration was observed. The combined procedure seemingly contributes to lower recurrence rate. No LUAO-related complications were reported. Moderate to high heterogeneity was observed for few outcomes. ConclusionThis is the first meta-analysis to date to provide a convincing overview of efficacy and safety of LUAO-LM. Although a medium risk of bias warrants some caution with interpretation of the results, LUAO-LM seemingly improves intra- and postoperative outcomes in women with symptomatic leiomyomas.

Hospitalized Patients' Knowledge of Care: a Systematic Review.

Patients' comprehension of their medical conditions is fundamental to patient-centered care. Hospitalizations present opportunities to educate patients but also challenges to patient comprehension given the complexity and rapid pace of clinical care. We conducted a systematic review of the literature to characterize the current state of inpatients' knowledge of their hospitalization, assess the methods used to determine patient comprehension, and appraise the effects of interventions on improving knowledge. We searched MEDLINE, EMBASE, and the Cochrane Library for articles published from January 1, 1995 through December 11, 2017. Eligible studies included patients under inpatient or observation status on internal medicine, family medicine, or neurology services. We extracted study characteristics (author, year, country, study design, sample size, patient characteristics, methods, intervention, primary endpoints, results) in a standardized fashion. The quality of observational studies was assessed using the NIH Quality Assessment Tool for Observation Cohort and Cross-Sectional Studies and the quality of interventional studies was assessed using adapted EPOC criteria from the Cochrane Collaboration. Twenty-eight studies met the criteria for inclusion, including 17 observational studies and 11 interventional studies. Patient knowledge of all aspects of their hospitalization was poor and patients often overestimated their knowledge. Older patients and those with lower education levels were more likely to have poorer knowledge. Intervention methods varied, but generally showed improvements in patient knowledge. Few interventional studies assessed the effect on health behaviors or outcomes and those that did were often underpowered. Clinicians should be aware that comprehension is often poor among hospitalized patients, especially in those with lower education and advanced age. Our results are limited by overall poor quality of interventional studies. Future research should use objective, standardized measures of patient comprehension and interventions should be multifaceted in approach, focusing on knowledge improvement while also addressing other factors influencing outcomes.

Terminology of Pelvic Floor Muscle Function in Women With and Without Urinary Incontinence: A Systematic Review.

Pelvic floor muscle function (PFMF) is a target of the physical therapist intervention for women with urinary incontinence (UI). However, possible variations in PFMF terminology might hamper communication among researchers and health care professionals in Women's Health. The objective of this study was to investigate the terminology of PFMF regarding clear terms, conceptual definitions, and operational definitions. Data sources include PUBMED, CINAHL, LILACS, and SCIELO. Observational studies investigating any PFMF in women with or without UI, published in English, Spanish, or Portuguese from 2005 through 2017, were considered. The risk of bias was assessed by a questionnaire on the quality of observational studies. Data on terminology were extracted as terms, conceptual definitions, and operational definitions of PFMF and were synthesized according to key words, key ideas, and key operationalization, respectively. Consistencies and variations were identified for the most frequently investigated PFMF. Sixty-four studies were included, and a low risk of bias was identified. All studies presented terms and operational definitions of PFMF, but only 29.7% presented conceptual definitions of those terms. One hundred ninety-six different terms referred to PFMF. According to similarities in terminology, 161 PFMF terms could be grouped under 26 terms; the other 35 were left ungrouped. Therefore, a total of 61 different PFMF terms were identified in the literature. A limitation in the study was that only observational studies were included. A large variation in PFMF terminology was identified, precluding data gathering and meta-analysis. The lack of use of standardized terminology delays the progress of scientific knowledge and evidence-based practice dissemination. Efforts toward creating a collaborative, consensual terminology based on a sound framework are necessary.

Environmental determinants of participation restriction after stroke: A systematic review of observational and qualitative studies

Introduction The International Classification of Functioning, Disability and Health (ICF) was published in 2001 by the World Health Organization (WHO) who defined participation restriction as the difficulty to achieve activities in daily life. The ICF allows to consider an individual in its global functioning then, participation restriction is the combined consequence of disability, activity limitation and contextual factors both personal and environmental. Participation is a major determinant of quality of life and life satisfaction in stroke patients, then for a given deficiency and activity limitation, consequences on participation may be very different depending on these contextual factors. However, there is limited evidence existing. The ICF defined two levels of environmental factors: “individual, direct environment” (interaction between an individual and his direct environment: physical environment, social and familial relationships) and “societal, global environment” (interaction with social, health services, lows and national policies). The aim of this systematic literature review is to better understand the role of environment in stroke patients’ functioning and precisely to identify which environmental determinants could be associated with participation restriction in stroke patients. Methods Searches were conducted in MEDLINE, PsycINFO, and Web of Science. The search algorithms were: for MEDLINE, (‘Stroke’[Mesh]) AND (‘Social Participation’[Mesh]); for PsycINFO and Web of science: ‘stroke and participation restriction’; ‘stroke and social participation’. The quality of observational studies was based on 4 criteria adapted from the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) checklist and quality of qualitative studies was based on four criteria adapted from the COREQ (Consolidated criteria for reporting qualitative research) checklist. Results Forty-one studies were retained for entire reading, full-text assessment of eligibility and quality. We eventually selected 16 articles, among them, 11 were quantitative studies and 5 were qualitative studies. The first level “individual, direct environment” was widely more studied in articles selected than the second level “societal, global environment”. Direct environment conceptualized as social support, attitudes towards the patient and physical environment were the mainly environmental determinant of participation restriction identified and appeared to be a major facilitator of participation. Global environment (access to health services and health policies) was only investigated in one study in the review and showed a significant association with participation, then appeared to be a facilitator of participation. Conclusion This is to our knowledge the first review which gathered evidence regarding environmental determinants of stroke patients’ participation, 16 studies were included. This review shows that two levels of environment: “individual, direct environment” and “societal, global environment” are facilitators of participation and should be considered in clinical practice, in rehabilitation programs and constitute issues for future intervention research.

Long-Term Quality of Life After Extracorporeal Membrane Oxygenation in ARDS Survivors: Systematic Review and Meta-Analysis.

Extracorporeal membrane oxygenation (ECMO) is an increasingly prevalent treatment for acute respiratory failure (ARF). To evaluate the impact of ECMO support on long-term outcomes for critically ill adults with ARF. We searched electronic databases 1948 through to November 30 2016; selected controlled trials or observational studies of critically ill adults with acute respiratory distress syndrome, examining long-term morbidity specifically health-related quality of life (HRQL); 2 authors independently selected studies, extracted data, and assessed methodological quality. Of the 633 citations, 1 randomized controlled trial and 5 observational studies met the selection criteria. Overall quality of observational studies was moderate to high (mean score on Newcastle-Ottawa scale, 7.2/9; range, 6-8). In 3 studies (n = 245), greater decrements in HRQL were seen for survivors of ECMO when compared to survivors of conventional mechanical ventilation (CMV) as measured by the Short Form 36 (SF-36) scores ([ECMO-CMV]: 5.40 [95% confidence interval, CI, 4.11 to 6.68]). As compared to CMV survivors, those who received ECMO experienced significantly less psychological morbidity (2 studies; n = 217 [ECMO-CMV]: mean weighted difference [MWD], -1.31 [95% CI, -1.98 to -0.64] for depression and MWD, -1.60 [95% CI, -1.80 to -1.39] for anxiety). Further studies are required to confirm findings and determine prognostic factors associated with more favorable outcomes in survivors of ECMO.

Exercise therapy for trismus secondary to head and neck cancer: A systematic review.

Effects of exercise therapy for trismus secondary to head and neck cancer have not been reviewed systematically since 2004. Four databases were searched. The quality of observational studies and randomized controlled trials was assessed. Two hundred eleven articles were found, 20 studies were included. A large variation in research methodology, stretching techniques, duration of stretch, and repetition of exercises was found. The overall quality was moderate. Five of the 8 preventive studies found that exercises during (chemo)radiotherapy could not prevent a reduction in mouth opening. In 4 therapeutic case studies, mouth opening increased between 17 and 24 mm. In 8 other therapeutic studies, mouth opening increased between -1.9 and 13.6 mm. No exercise therapy was clearly superior to the others. Changes in mouth opening ranged considerably and no stretching technique was superior to others regarding either prevention or treatment of trismus. Clinical guidelines cannot be given based on this systematic review. © 2016 Wiley Periodicals, Inc. Head Neck 39: 160-169, 2017.

Individual, social and environmental determinants of sleep among women: protocol for a systematic review and meta-analysis

IntroductionSleep is important to promote optimal health and avoid negative health outcomes. Short-duration and low-quality sleep may be more common and more detrimental among women compared with men. Identifying the...

Organization of care for persons with HIV-infection: a systematic review

ABSTRACTThe objective of this systematic review was to examine the effectiveness of the organization of care: case management, multidisciplinary care, multi-faceted treatment, hours of service, outreach programs and health information systems on medical, immunological, virological, psychosocial and economic outcomes for persons living with HIV/AIDS. We searched PubMed (MEDLINE) and 10 other electronic databases from 1 January 1980 to April, 2012 for both experimental and controlled observational studies. Thirty-three studies met the inclusion criteria. Eleven studies were randomized controlled trials (RCTs), three of which were conducted in low–middle income settings. Patient characteristics, study design, organization measures and outcomes data were abstracted independently by two reviewers from all studies. A risk of bias tool was applied to RCTs and a separate tool was used to assess the quality of observational studies. This review concludes that case management interventions were most consistently associated with improvements in immunological outcomes but case management demonstrates no clear association with other outcome measures. The same mixed results were also identified for multidisciplinary and multi-faceted care interventions. Eight studies with an outreach intervention were identified and demonstrated improvements or non-inferiority with respect to mortality, receipt of antiretroviral medications, immunological outcomes, improvements in healthcare utilization and lower reported healthcare costs when compared to usual care. Of the interventions examined in this review, sustained in-person case management and outreach interventions were most consistently associated with improved medical and economic outcomes, in particular antiretroviral prescribing, immunological outcomes and healthcare utilization. No firm conclusions can be reached about the impact of any one intervention on patient mortality.

Exercise therapy for trismus secondary to head and neck cancer: A systematic review.

Effects of exercise therapy for trismus secondary to head and neck cancer have not been reviewed systematically since 2004. Four databases were searched. The quality of observational studies and randomized controlled trials was assessed. Two hundred eleven articles were found, 20 studies were included. A large variation in research methodology, stretching techniques, duration of stretch, and repetition of exercises was found. The overall quality was moderate. Five of the 8 preventive studies found that exercises during (chemo)radiotherapy could not prevent a reduction in mouth opening. In 4 therapeutic case studies, mouth opening increased between 17 and 24 mm. In 8 other therapeutic studies, mouth opening increased between -1.9 and 13.6 mm. No exercise therapy was clearly superior to the others. Changes in mouth opening ranged considerably and no stretching technique was superior to others regarding either prevention or treatment of trismus. Clinical guidelines cannot be given based on this systematic review. © 2016 Wiley Periodicals, Inc. Head Neck 39: 160-169, 2017.

Reported burden on informal caregivers of ICU survivors: a literature review.

BackgroundCritical illness and the problems faced after ICU discharge do not only affect the patient, it also negatively impacts patients’ informal caregivers. There is no review which summarizes all types of burden reported in informal caregivers of ICU survivors. It is important that the burdens these informal caregivers suffer are systematically assessed so the caregivers can receive the professional care they need. We aimed to provide a complete overview of the types of burdens reported in informal caregivers of adult ICU survivors, to make recommendations on which burdens should be assessed in this population, and which tools should be used to assess them.MethodWe performed a systematic search in PubMed and CINAHL from database inception until June 2014. All articles reporting on burdens in informal caregivers of adult ICU survivors were included. Two independent reviewers used a standardized form to extract characteristics of informal caregivers, types of burdens and instruments used to assess these burdens. The quality of the included studies was assessed using the Newcastle-Ottawa and the PEDro scales.ResultsThe search yielded 2704 articles, of which we included 28 in our review. The most commonly reported outcomes were psychosocial burden. Six months after ICU discharge, the prevalence of anxiety was between 15 % and 24 %, depression between 4.7 % and 36.4 % and post-traumatic stress disorder (PTSD) between 35 % and 57.1 %. Loss of employment, financial burden, lifestyle interference and low health-related quality of life (HRQoL) were also frequently reported. The most commonly used tools were the Hospital Anxiety and Depression Scale (HADS), Centre for Epidemiological Studies-Depression questionnaire, and Impact of Event Scale (IES). The quality of observational studies was low and of randomized studies moderate to fair.ConclusionsInformal caregivers of ICU survivors suffer a substantial variety of burdens. Although the quality of the included studies was poor, there is evidence that burden in the psychosocial field is most prevalent. We suggest screening informal caregivers of ICU survivors for anxiety, depression, PTSD, and HRQoL using respectively the HADS, IES and Short Form 36 and recommend a follow-up period of at least 6 months.Electronic supplementary materialThe online version of this article (doi:10.1186/s13054-016-1185-9) contains supplementary material, which is available to authorized users.

TOTAL CHOLESTEROL, LOW-DENSITY LIPOPROTEIN CHOLESTEROL, OR HIGH DENSITY LIPOPROTEIN AND BONE HEALTH: SYSTEMATIC REVIEW AND MENDELIAN RANDOMIZATION

TOTAL CHOLESTEROL, LOW-DENSITY LIPOPROTEIN CHOLESTEROL, OR HIGH DENSITY LIPOPROTEIN AND BONE HEALTH: SYSTEMATIC REVIEW AND MENDELIAN RANDOMIZATION

Methotrexate and liver fibrosis in people with psoriasis: a systematic review of observational studies

Methotrexate (MTX) is an effective treatment for psoriasis but concerns regarding the development of liver fibrosis prevent optimal use. The primary objective of this systematic review was to assess whether MTX use increases the risk of developing fibrosis in people with psoriasis. Searches were performed on Medline, Embase, the Cochrane Database and Clinical Trials Register from inception until September 2013 for studies including at least two liver biopsies in people with psoriasis. Double extraction using predefined data fields was performed. Randomized controlled trials and observational studies were considered. Statistical analysis was performed using Review Manager 5. Quality of observational studies was assessed using a study quality bias checklist. Eight observational studies met the inclusion criteria (n = 429 patients). The pooled risk difference (RD) of developing significant liver fibrosis was 0·09 [95% confidence interval (CI) -0·03 to 0·20]. The RD for developing 'any fibrosis' was 0·22 (95% CI 0·04-0·41). The RD for cirrhosis was 0·04 (95% CI 0·02-0·07). There was no clear association between cumulative dose of MTX and fibrosis. Obesity, diabetes and alcohol use were under-reported. The quality of the included studies was weak and the degree of selection bias means the results are not generalizable to all patients with psoriasis taking MTX. High-quality, population-based studies that consider potential confounders common in psoriasis population are justified for better prediction of the subset of patients at risk of liver fibrosis. In this highly selected review population, MTX use appears to contribute to the development of 'any' fibrosis without clear evidence of risk stratifiers.

Endovascular Aneurysm Repair Versus Open Repair for Patients With a Ruptured Abdominal Aortic Aneurysm: A Systematic Review and Meta-analysis of Short-term Survival

There is clinical equipoise between open (OR) and endovascular aneurysm repair (EVAR) for the best treatment of ruptured abdominal aortic aneurysm (RAAA). The aim of the study was to perform a systematic review and meta-analysis to estimate the short-term (combined 30-day or in-hospital) survival after EVAR and OR for patients with RAAA. Data sources included Medline, Embase, and the World Health Organization International Clinical Trials Registry until 13 January 2014. All randomised controlled trials (RCTs), observational cohort studies, and administrative registries comparing OR and EVAR of at least 50 patients were included. Articles were full-length and in English. Standard PRISMA guidelines were followed. The methodological quality of RCTs was assessed with the Cochrane Collaboration's tool for assessing risk of bias. The quality of observational studies was assessed with a modified Cochrane Collaboration's tool for assessing risk of bias, the Newcastle–Ottawa Scale, and the Methodological Index for Non-Randomized Studies. The results of the RCTs, of the obersvational studies, and of the administrative registries were pooled separately and analysed with the use of a random effects model. From a total of 3,769 articles, three RCTs, 21 observational studies, and eight administrative registries met the inclusion criteria. In the RCTs, the risk of bias was lowest and the pooled odds ratio for death after EVAR versus OR was 0.90 (95% CI 0.65-1.24). The majority of the observational studies had a high risk of bias and the pooled odds ratio for death was 0.44 (95% CI 0.37-0.53). The majority of the administrative registries had a high risk of bias and the pooled odds ratio for death was 0.54 (95% CI 0.47-0.62). Endovascular aneurysm repair is not inferior to open repair in patients with a ruptured abdominal aortic aneurysm. This supports the use of EVAR in suitable patients and OR as a reasonable alternative.

Reducing the Burden of Surgical Harm

To perform a systematic review of interventions used to reduce adverse events in surgery. Many interventions, which aim to improve patient safety in surgery, have been introduced to hospitals. Little is known about which methods provide a measurable decrease in morbidity and mortality. MEDLINE, EMBASE, and Cochrane databases were searched from inception to Week 19, 2012, for systematic reviews, randomized controlled trials (RCTs), and cross-sectional and cohort studies, which reported an intervention aimed toward reducing the incidence of adverse events in surgical patients. The quality of observational studies was measured using the Newcastle-Ottawa Scale. RCTs were assessed using the Cochrane Collaboration's tool for assessing risk of bias. Ninety-one studies met inclusion criteria, 26 relating to structural interventions, 66 described modifying process factors. Only 17 (of 42 medium to high quality studies) reported an intervention that produced a significant decrease in morbidity and mortality. Structural interventions were: improving nurse to patient ratios (P = 0.008) and Intensive Care Unit (ITU) physician involvement in postoperative care (P < 0.05). Subspecialization in surgery reduced technical complications (P < 0.01). Effective process interventions were submission of outcome data to national audit (P < 0.05), use of safety checklists (P < 0.05), and adherence to a care pathway (P < 0.05). Certain safety technology significantly reduced harm (P = 0.02), and team training had a positive effect on patient outcome (P = 0.001). Only a small cohort of medium- to high-quality interventions effectively reduce surgical harm and are feasible to implement. It is important that future research remains focused on demonstrating a measurable reduction in adverse events from patient safety initiatives.

The Catch-22 of appraisals on the quality of observational studies

The Catch-22 of appraisals on the quality of observational studies

Postmarketing evidence of disease-modifying drugs in multiple sclerosis

There is growing interest in the use of observational data to estimate treatment effects in chronic diseases such as multiple sclerosis (MS). The main results derived from postmarketing evaluations, in the last 2 years, of short-and long-term disease modifying drugs (DMDs) effectiveness will be reported in this Review. Moreover, some of the methodological improvements that may be useful to enhance the quality of observational studies will also be discussed.