Methods used to assess outcome consistency in clinical studies: A literature-based evaluation.

Evaluation studies of outcomes used in clinical research and their consistency are appearing more frequently in the literature, as a key part of the core outcome set (COS) development. Current guidance suggests such evaluation studies should use systematic review methodology as their default. We aimed to examine the methods used. We searched the Core Outcome Measures in Effectiveness Trials (COMET) database (up to May 2019) supplementing it with additional resources. We included evaluation studies of outcome consistency in clinical studies across health subjects and used a subset of A MeaSurement Tool to Assess systematic Reviews (AMSTAR) 2 (items 1-9) to assess their methods. Of 93 included evaluation studies of outcome consistency (90 full reports, three summaries), 91% (85/93) reported performing literature searches in at least one bibliographic database, and 79% (73/93) was labelled as a "systematic review". The evaluations varied in terms of satisfying AMSTAR 2 criteria, such that 81/93 (87%) had implemented PICO in the research question, whereas only 5/93 (6%) had included the exclusions list. None of the evaluation studies explained how inconsistency of outcomes was detected, however, 80/90 (88%) concluded inconsistency in individual outcomes (66%, 55/90) or outcome domains (20%, 18/90). Methods used in evaluation studies of outcome consistency in clinical studies differed considerably. Despite frequent being labelled as a "systematic review", adoption of systematic review methodology is selective. While the impact on COS development is unknown, authors of these studies should refrain from labelling them as "systematic review" and focus on ensuring that the methods used to generate the different outcomes and outcome domains are reported transparently

Outcomes of obstructed abdominal wall hernia: results from the UK national small bowel obstruction audit

Background: Abdominal wall hernia is a common surgical condition. Patients may present in an emergency with bowel obstruction, incarceration or strangulation. Small bowel obstruction (SBO) is a serious surgical condition associated with significant morbidity. The aim of this study was to describe current management and outcomes of patients with obstructed hernia in the UK as identified in the National Audit of Small Bowel Obstruction (NASBO). Methods: NASBO collated data on adults treated for SBO at 131 UK hospitals between January and March 2017. Those with obstruction due to abdominal wall hernia were included in this study. Demographics, co-morbidity, imaging, operative treatment, and in-hospital outcomes were recorded. Modelling for factors associated with mortality and complications was undertaken using Cox proportional hazards and multivariable regression modelling. Results: NASBO included 2341 patients, of whom 415 (17·7 per cent) had SBO due to hernia. Surgery was performed in 312 (75·2 per cent) of the 415 patients; small bowel resection was required in 198 (63·5 per cent) of these operations. Non-operative management was reported in 35 (54 per cent) of 65 patients with a parastomal hernia and in 34 (32·1 per cent) of 106 patients with an incisional hernia. The in-hospital mortality rate was 9·4 per cent (39 of 415), and was highest in patients with a groin hernia (11·1 per cent, 17 of 153). Complications were common, including lower respiratory tract infection in 16·3 per cent of patients with a groin hernia. Increased age was associated with an increased risk of death (hazard ratio 1·05, 95 per cent c.i. 1·01 to 1·10; P = 0·009) and complications (odds ratio 1·05, 95 per cent c.i. 1·02 to 1·09; P = 0·001). Conclusion: NASBO has highlighted poor outcomes for patients with SBO due to hernia, highlighting the need for quality improvement initiatives in this group

Outcomes of obstructed abdominal wall hernia: results from the UK national small bowel obstruction audit

Background Abdominal wall hernia is a common surgical condition. Patients may present in an emergency with bowel obstruction, incarceration or strangulation. Small bowel obstruction (SBO) is a serious surgical condition associated with significant morbidity. The aim of this study was to describe current management and outcomes of patients with obstructed hernia in the UK as identified in the National Audit of Small Bowel Obstruction (NASBO). Methods NASBO collated data on adults treated for SBO at 131 UK hospitals between January and March 2017. Those with obstruction due to abdominal wall hernia were included in this study. Demographics, co‐morbidity, imaging, operative treatment, and in‐hospital outcomes were recorded. Modelling for factors associated with mortality and complications was undertaken using Cox proportional hazards and multivariable regression modelling. Results NASBO included 2341 patients, of whom 415 (17·7 per cent) had SBO due to hernia. Surgery was performed in 312 (75·2 per cent) of the 415 patients; small bowel resection was required in 198 (63·5 per cent) of these operations. Non‐operative management was reported in 35 (54 per cent) of 65 patients with a parastomal hernia and in 34 (32·1 per cent) of 106 patients with an incisional hernia. The in‐hospital mortality rate was 9·4 per cent (39 of 415), and was highest in patients with a groin hernia (11·1 per cent, 17 of 153). Complications were common, including lower respiratory tract infection in 16·3 per cent of patients with a groin hernia. Increased age was associated with an increased risk of death (hazard ratio 1·05, 95 per cent c.i. 1·01 to 1·10; P = 0·009) and complications (odds ratio 1·05, 95 per cent c.i. 1·02 to 1·09; P = 0·001). Conclusion NASBO has highlighted poor outcomes for patients with SBO due to hernia, highlighting the need for quality improvement initiatives in this group

National prospective cohort study of the burden of acute small bowel obstruction

Background Small bowel obstruction is a common surgical emergency, and is associated with high levels of morbidity and mortality across the world. The literature provides little information on the conservatively managed group. The aim of this study was to describe the burden of small bowel obstruction in the UK. Methods This prospective cohort study was conducted in 131 acute hospitals in the UK between January and April 2017, delivered by trainee research collaboratives. Adult patients with a diagnosis of mechanical small bowel obstruction were included. The primary outcome was in‐hospital mortality. Secondary outcomes included complications, unplanned intensive care admission and readmission within 30 days of discharge. Practice measures, including use of radiological investigations, water soluble contrast, operative and nutritional interventions, were collected. Results Of 2341 patients identified, 693 (29·6 per cent) underwent immediate surgery (within 24 h of admission), 500 (21·4 per cent) had delayed surgery after initial conservative management, and 1148 (49·0 per cent) were managed non‐operatively. The mortality rate was 6·6 per cent (6·4 per cent for non‐operative management, 6·8 per cent for immediate surgery, 6·8 per cent for delayed surgery; P = 0·911). The major complication rate was 14·4 per cent overall, affecting 19·0 per cent in the immediate surgery, 23·6 per cent in the delayed surgery and 7·7 per cent in the non‐operative management groups (P < 0·001). Cox regression found hernia or malignant aetiology and malnutrition to be associated with higher rates of death. Malignant aetiology, operative intervention, acute kidney injury and malnutrition were associated with increased risk of major complication. Conclusion Small bowel obstruction represents a significant healthcare burden. Patient‐level factors such as timing of surgery, acute kidney injury and nutritional status are factors that might be modified to improve outcomes

Outcomes following small bowel obstruction due to malignancy in the national audit of small bowel obstruction

Introduction Patients with cancer who develop small bowel obstruction are at high risk of malnutrition and morbidity following compromise of gastrointestinal tract continuity. This study aimed to characterise current management and outcomes following malignant small bowel obstruction. Methods A prospective, multicentre cohort study of patients with small bowel obstruction who presented to UK hospitals between 16th January and 13th March 2017. Patients who presented with small bowel obstruction due to primary tumours of the intestine (excluding left-sided colonic tumours) or disseminated intra-abdominal malignancy were included. Outcomes included 30-day mortality and in-hospital complications. Cox-proportional hazards models were used to generate adjusted effects estimates, which are presented as hazard ratios (HR) alongside the corresponding 95% confidence interval (95% CI). The threshold for statistical significance was set at the level of P ≤ 0.05 a-priori. Results 205 patients with malignant small bowel obstruction presented to emergency surgery services during the study period. Of these patients, 50 had obstruction due to right sided colon cancer, 143 due to disseminated intraabdominal malignancy, 10 had primary tumours of the small bowel and 2 patients had gastrointestinal stromal tumours. In total 100 out of 205 patients underwent a surgical intervention for obstruction. 30-day in-hospital mortality rate was 11.3% for those with primary tumours and 19.6% for those with disseminated malignancy. Severe risk of malnutrition was an independent predictor for poor mortality in this cohort (adjusted HR 16.18, 95% CI 1.86 to 140.84, p = 0.012). Patients with right-sided colon cancer had high rates of morbidity. Conclusions Mortality rates were high in patients with disseminated malignancy and in those with right sided colon cancer. Further research should identify optimal management strategy to reduce morbidity for these patient groups

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Association of exposure to air pollution and green space with ovarian reserve hormones levels

Exposure to air pollution has been associated with adverse health effects while exposure to greenspace has been associated with public health benefits. However, the available evidence on the association of exposure to air pollution with ovarian reserve markers is still scarce, with no study on such an association with greenspace exposure. Therefore, this study aimed to investigate the association of exposure to particulate matter with diameter of less than 1, 2.5 and 10 μm (PM1, PM2.5, PM10), traffic indicators (distance from women's residence to major roads and total street length in different buffers around women's residential address) and greenspace indicators (residential surrounding greenspace and distance to green spaces) with serum levels of anti-müllerian hormone (AMH) and follicle stimulating hormone (FSH) as markers of ovarian reserve. This cross-sectional study was based on 67 women residing in Sabzevar, Iran (2018). Basal serum levels of FSH and AMH were measured by the enzyme-linked immunosorbent assays (ELISA). Land use regression models were used to estimate PMs concentrations at residential addresses and the average of normalized difference vegetation index (NDVI) in different buffers was used to characterize residential surrounding greenspace. Multiple linear regression models were developed to estimate the association of AMH and FSH with exposure to air pollution, traffic, and greenspace (one at a time) controlled for relevant covariates. In fully adjusted models, there was an inverse association between exposure to PM1, PM2.5 as well as total street length in 100 m buffer around women's residence and AMH level (β = �0.89, 95 confidence interval (CI): �1.43, �0.35, P-value � 0.01, β = �1.11, 95 CI: �1.67, �0.55, P-value � 0.01 and β = �0.76, 95 CI: �1.48, �0.50, P-value = 0.03, respectively). Moreover, increase in distance from home to nearest major road as well as residential surrounding greenspace (100 m buffer) and decrease in residential distance to a green space larger than 5000 m2 were associated with increase in serum level of AMH. However, we did not observe any significant association between exposure to air pollution, traffic, and greenspace with FSH level. Overall, our findings supported a beneficial association of exposure to greenspace and detrimental association of exposure to air pollution with ovarian reserve. © 2020 Elsevier Inc

Ecological and health risk assessment of exposure to atmospheric heavy metals

In the present study, we assessed the concentration of airborne HMs (Zn, Cu, Pb, and Cd) and their probable sources using the bark of Pinus eldarica as a bio-indicator. Hence, 47 tree bark samples were harvested according to the land uses and biomonitoring techniques in the city of Yazd, Iran. The potential health risks in 13 age groups, ecological risk, as well as the possible relationship between HM concentrations and traffic indicators, were evaluated. The order of average HM concentrations in the P. eldarica bark samples was as Zn &gt; Pb &gt; Cu &gt; Cd. The mean values of non-carcinogenic risks of all HMs in entire age groups were within secure range (HQ &lt; 1); however, the carcinogenic risk of Cd was higher than the allowed level (TCR &gt; 1 � 10�6). About Pb, it was in the safe level. The main element causing potential ecological risks was Cd, indicating moderate to very high ecological risk in most of the study areas. There was an inverse significant association between distance from major roads and Pb concentration (β = �0.011 95 confidence interval (CI): 0.022, �0.0001). All HMs in bark samples render the negative Moran's index, representing a random spatial distribution pattern. Besides, according to principal component analysis (PCA), the first component accounted for 36.55 of the total variance, dominated by Cd, Pb, Cu, and Zn, respectively, and characterized by vehicle and industrial emissions. Our results infer that industrial activities and traffic are the main sources of HMs pollution in urban environments that should be considered by decision-makers. © 2019 Elsevier Inc