Development of a Core Outcome Set for Studies Assessing Interventions for Diabetes-Related Foot Ulceration.

OBJECTIVE: Diabetes affects 537 million people globally, with 34% expected to develop foot ulceration in their lifetime. Diabetes-related foot ulceration causes strain on health care systems worldwide, necessitating provision of high-quality evidence to guide their management. Given heterogeneity of reported outcomes, a core outcome set (COS) was developed to standardize outcome measures in studies assessing treatments for diabetes-related foot ulceration. RESEARCH DESIGN AND METHODS: The COS was developed using Core Outcome Measures in Effectiveness Trials (COMET) methodology. A systematic review and patient interviews generated a long list of outcomes that were rated by patients and experts using a nine-point Likert scale (from 1 [not important] to 9 [critical]) in the first round of the Delphi survey. Based on predefined criteria, outcomes without consensus were reprioritized in a second Delphi round. Critical outcomes and those without consensus after two Delphi rounds were discussed in the consensus meeting where the COS was ratified. RESULTS: The systematic review and patient interviews generated 103 candidate outcomes. The two consecutive Delphi rounds were completed by 336 and 176 respondents, resulting in an overall second round response rate of 52%. Of 37 outcomes discussed in the consensus meeting (22 critical and 15 without consensus after the second round), 8 formed the COS: wound healing, time to healing, new/recurrent ulceration, infection, major amputation, minor amputation, health-related quality of life, and mortality. CONCLUSIONS: The proposed COS for studies assessing treatments for diabetes-related foot ulceration was developed using COMET methodology. Its adoption by the research community will facilitate assessment of comparative effectiveness of current and evolving interventions.

Significance of thickening of the upper gastrointestinal tract on cross sectional imaging: Endoscopic correlation.

AIM: To report the endoscopic findings for a cohort of patients referred for discussion at a specialist oesophago-gastric multi-disciplinary team (MDT) meeting, on the basis of CT mural thickening. PATIENTS AND METHODS: The records of patients discussed at a regional oesophago-gastric MDT during the time 1st April 2014 to 5th February 2016 were reviewed in order to identify patients who were endoscopy naïve at the time of CT and scans re-reviewed to measure maximum wall thickness. RESULTS: 456 patients were referred for discussion, 126 met the inclusion criteria. Endoscopy confirmed malignancy in 50/126 patients (40%); by site, oesophagus (21/67, 31%), stomach (25/50, 50%), duodenum (4/9, 44%). Malignancy was confirmed for 10/48 (21%) patients with isolated wall thickening, for 11/33 (33%) when regional lymphadenopathy was identified, and for 28/44 (64%) when possible metastatic disease was identified. The commonest source of diagnostic uncertainty was thickening around the gastro-oesophageal junction in the presence of a hiatal hernia. Wall thickening >20 mm was strongly associated with malignancy compared to thickening =<20 mm (p < 0.0001). Using this threshold would have resulted in a sensitivity of 32/50 (64%), a specificity of 55/76 (72%), a positive predictive value of 32/53 (60%) and a negative predictive value of 55/73 (75%) in this cohort. CONCLUSIONS: The cancer pick-up rate of 40% and the medicolegal consequences of a missed cancer suggest that endoscopy should be performed in all patients with CT identified mural thickening. In the presence of isolated mural thickening and a normal endoscopy, no formal MDT discussion is required.

Maternal outcomes in subsequent delivery after previous obstetric anal sphincter injury (OASI): a multi-centre retrospective cohort study.

INTRODUCTION AND HYPOTHESIS: Women with a history of obstetric anal sphincter injury (OASI) are at increased risk of recurrence (rOASI) at subsequent delivery; however, evidence regarding the factors influencing this risk is limited. Furthermore, little is known about what factors influence the decision to alternatively deliver by elective caesarean section (ELLSCS). METHODS: Retrospective univariate and multivariate logistic regression analysis of prospectively collected data from four NHS electronic maternity databases including primiparous women sustaining OASIS during a singleton, term, cephalic, vaginal delivery between 2004 and 2015, who had a subsequent delivery. RESULTS: Two thousand two hundred seventy-two women met the criteria; 10.2% delivering vaginally had a repeat OASI and 59.4% had a second-degree tear. Women having an ELLSCS were more likely to be Caucasian, older, have previously had an operative vaginal delivery (OVD) and have a more severe degree of OASI. Positive predictors for rOASI were increased birth weight and maternal age at both index and subsequent deliveries, a more severe degree of initial OASI and Asian ethnicity. The overall mediolateral episiotomy (MLE) rate was 15.6%; 77.2% of those who had an episiotomy sustained no spontaneous perineal trauma. Only 4.4% of women with a rOASI had an MLE, whilst the MLE rate was 16.9% in those without a recurrence (p < 0.001). MLE decreased the risk of rOASI by 80%. Birth weight > 4 kg increased the risk 2.5 fold. CONCLUSIONS: Women with previous OASIS are at an increased risk of recurrence. A more liberal use of MLE during subsequent vaginal delivery could significantly reduce the risk of recurrence.