James M.N. Duffy

A core outcome set for evaluation of interventions to prevent preterm birth.

OBJECTIVE: To develop a consensus on a set of key clinical outcomes for the evaluation of preventive interventions for preterm birth in asymptomatic pregnant women. METHODS: A two-stage web-based Delphi survey and a face-to-face meeting of key stakeholders were used to develop a consensus on a set of critical and important outcomes. We approached five stakeholder groups (parents, midwives, obstetricians, neonatologists, and researchers) from middle- and high-income countries. Outcomes subjected to the Delphi survey were identified by systematic literature review and stakeholder input. Survey participants scored each outcome on a 9-point Likert scale anchored between 1 (limited importance) and 9 (critical importance). They had the opportunity to reflect on total and stakeholder subgroup feedback between survey stages. For consensus, defined a priori, outcomes required at least 70% of participants of each stakeholder group to score them as “critical” and less than 15% as “limited.” RESULTS: A total of 228 participants from five stakeholder groups from three lower middle-income countries, seven upper middle-income countries, and 17 high-income countries were asked to score 31 outcomes. Of these participants, 195 completed the first survey and 174 the second. Consensus was reached on 13 core outcomes: four were related to pregnant women: maternal mortality, maternal infection or inflammation, prelabor rupture of membranes, and harm to mother from intervention. Nine were related to offspring: gestational age at birth, offspring mortality, birth weight, early neurodevelopmental morbidity, late neurodevelopmental morbidity, gastrointestinal morbidity, infection, respiratory morbidity, and harm to offspring from intervention. CONCLUSION: This core outcome set for studies that evaluate prevention of preterm birth developed with an international multidisciplinary perspective will ensure that data from trials that assess prevention of preterm birth can be compared and combined. DATABASE REGISTRATION: COMET Initiative, http://www.comet-initiative.org/studies/details/603, Registration Number: 603.

Variation in outcome reporting in endometriosis trials: a systematic review

OBJECTIVE We reviewed the outcomes and outcome measures reported in randomized controlled trials and their relationship with methodological quality, year of publication, commercial funding, and journal impact factor. DATA SOURCES We searched the following sources: (1) Cochrane Central Register of Controlled Trials, (2) Embase, and (3) MEDLINE from inception to November 2014. STUDY ELIGIBILITY We included all randomized controlled trials evaluating a surgical intervention with or without a medical adjuvant therapy for the treatment of endometriosis symptoms. STUDY DESIGN Two authors independently selected trials, assessed methodological quality (Jadad score; range, 1-5), outcome reporting quality (Management of Otitis Media with Effusion in Cleft Palate criteria; range, 1-6), year of publication, impact factor in the year of publication, and commercial funding (yes or no). Univariate and bivariate analyses were performed using Spearman Rh and Mann-Whitney U tests. We used a multivariate linear regression model to assess relationship associations between outcome reporting quality and other variables. RESULTS There were 54 randomized controlled trials (5427 participants), which reported 164 outcomes and 113 outcome measures. The 3 most commonly reported primary outcomes were dysmenorrhea (10 outcome measures; 23 trials), dyspareunia (11 outcome measures; 21 trials), and pregnancy (3 outcome measures; 26 trials). The median quality of outcome reporting was 3 (interquartile range 4-2) and methodological quality 3 (interquartile range 5-2). Multivariate linear regression demonstrated a relationship between outcome reporting quality with methodological quality (β = 0.325; P = .038) and year of publication (β = 0.067; P = .040). No relationship was demonstrated between outcome reporting quality with journal impact factor (Rho = 0.190; P = .212) or commercial funding (P = .370). CONCLUSION Variation in outcome reporting within published endometriosis trials prohibits comparison, combination, and synthesis of data. This limits the usefulness of research to inform clinical practice, enhance patient care, and improve patient outcomes. In the absence of a core outcome set for endometriosis we recommend the use of the 3 most common pain (dysmenorrhea, dyspareunia, and pelvic pain) and subfertility (pregnancy, miscarriage, and live birth) outcomes. International consensus among stakeholders is needed to establish a core outcome set for endometriosis trials.

Developing, implementing and disseminating a core outcome set for neonatal medicine.

Background In high resource settings, 1 in 10 newborn babies require admission to a neonatal unit. Research evaluating neonatal care involves recording and reporting many different outcomes and outcome measures. Such variation limits the usefulness of research as studies cannot be compared or combined. To address these limitations, we aim to develop, disseminate and implement a core outcome set for neonatal medicine. Methods A steering group that includes parents and former patients, healthcare professionals and researchers has been formed to guide the development of the core outcome set. We will review neonatal trials systematically to identify previously reported outcomes. Additionally, we will specifically identify outcomes of importance to parents, former patients and healthcare professionals through a systematic review of qualitative studies. Outcomes identified will be entered into an international, multi-perspective eDelphi survey. All key stakeholders will be invited to participate. The Delphi method will encourage individual and group stakeholder consensus to identify a core outcome set. The core outcome set will be mapped to existing, routinely recorded data where these exist. Discussion Use of a core set will ensure outcomes of importance to key stakeholders, including former patients and parents, are recorded and reported in a standard fashion in future research. Embedding the core outcome set within future clinical studies will extend the usefulness of research to inform practice, enhance patient care and ultimately improve outcomes. Using routinely recorded electronic data will facilitate implementation with minimal addition burden. Trial registration number Core Outcome Measures in Effectiveness Trials (COMET) database: 842 (www.comet-initiative.org/studies/details/842).

Standardizing abortion research outcomes (STAR): a protocol for developing, disseminating and implementing a core outcome set for medical and surgical abortion

Author(s): Whitehouse, Katherine C; Kim, Caron R; Ganatra, Bela; Duffy, James MN; Blum, Jennifer; Brahmi, Dalia; Creinin, Mitchell D; DePineres, Teresa; Gemzell-Danielsson, Kristina; Grossman, Daniel; Winikoff, Beverly; Gulmezoglu, A Metin

Protocol for developing, disseminating and implementing a core outcome set for endometriosis

Introduction Endometriosis is a common gynaecological disease characterised by pain and subfertility. Randomised controlled trials evaluating treatments for endometriosis have reported many different outcomes and outcome measures. This variation restricts effective data synthesis limiting the usefulness of research to inform clinical practice. To address these methodological concerns, we aim to develop, disseminate and implement a core outcome set for endometriosis engaging with key stakeholders, including healthcare professionals, researchers and women with endometriosis. Methods and analysis An international steering group has been established, including healthcare professionals, researchers and patient representatives. Potential outcomes identified from a systematic review of the literature will be entered into a modified Delphi method. Key stakeholders will be invited to participate including healthcare professionals, researchers and women with endometriosis. Participants will be invited to score individual outcomes on a nine-point Likert scale anchored between 1 (not important) and 9 (critical). Repeated reflection and rescoring should promote whole and individual stakeholder group converge towards consensus, ‘core’, outcomes. High-quality outcome measures will be associated with core outcomes. Ethics and dissemination The implementation of a core outcome set for endometriosis within future clinical trials, systematic reviews and clinical guidelines will enhance the availability of comparable data to facilitate evidence-based patient care. This study was prospectively registered with Core Outcome Measures in Effectiveness Trials Initiative; number: 691.

Googling endometriosis: a systematic review of information available on the Internet

BACKGROUND: The demand for health information online is increasing rapidly without clear governance. OBJECTIVE: We aim to evaluate the credibility, quality, readability, and accuracy of online patient information concerning endometriosis. STUDY DESIGN: We searched 5 popular Internet search engines: aol.com, ask.com, bing.com, google.com, and yahoo.com. We developed a search strategy in consultation with patients with endometriosis, to identify relevant World Wide Web pages. Pages containing information related to endometriosis for women with endometriosis or the public were eligible. Two independent authors screened the search results. World Wide Web pages were evaluated using validated instruments across 3 of the 4 following domains: (1) credibility (White Paper instrument; range 0‐10); (2) quality (DISCERN instrument; range 0‐85); and (3) readability (Flesch‐Kincaid instrument; range 0‐100); and (4) accuracy (assessed by a prioritized criteria developed in consultation with health care professionals, researchers, and women with endometriosis based on the European Society of Human Reproduction and Embryology guidelines [range 0‐30]). We summarized these data in diagrams, tables, and narratively. RESULTS: We identified 750 World Wide Web pages, of which 54 were included. Over a third of Web pages did not attribute authorship and almost half the included pages did not report the sources of information or academic references. No World Wide Web page provided information assessed as being written in plain English. A minority of web pages were assessed as high quality. A single World Wide Web page provided accurate information: evidentlycochrane.net. Available information was, in general, skewed toward the diagnosis of endometriosis. There were 16 credible World Wide Web pages, however the content limitations were infrequently discussed. No World Wide Web page scored highly across all 4 domains. CONCLUSION: In the unlikely event that a World Wide Web page reports high‐quality, accurate, and credible health information it is typically challenging for a lay audience to comprehend. Health care professionals, and the wider community, should inform women with endometriosis of the risk of outdated, inaccurate, or even dangerous information online. The implementation of an information standard will incentivize providers of online information to establish and adhere to codes of conduct.

Inadequate safety reporting in pre-eclampsia trials: a systematic evaluation

Randomised trials and their syntheses in meta‐analyses offer a unique opportunity to assess the frequency and severity of adverse reactions.

Twin–Twin Transfusion Syndrome: study protocol for developing, disseminating, and implementing a core outcome set

BackgroundTwin–Twin Transfusion Syndrome (TTTS) is associated with an increased risk of perinatal mortality and morbidity. Several treatment interventions have been described for TTTS, including fetoscopic laser surgery, amnioreduction, septostomy, expectant management, and pregnancy termination. Over the last decade, fetoscopic laser surgery has become the primary treatment. The literature to date reports on many different outcomes, making it difficult to compare results or combine data from individual studies, limiting the value of research to guide clinical practice. With the advent and ongoing development of new therapeutic techniques, this is more important than ever. The development and use of a core outcome set has been proposed to address these issues, prioritising outcomes important to the key stakeholders, including patients. We aim to produce, disseminate, and implement a core outcome set for TTTS.MethodsAn international steering group has been established to oversee the development of this core outcome set. This group includes healthcare professionals, researchers and patients. A systematic review is planned to identify previously reported outcomes following treatment for TTTS. Following completion, the identified outcomes will be evaluated by stakeholders using an international, multi-perspective online modified Delphi method to build consensus on core outcomes. This method encourages the participants towards consensus ‘core’ outcomes. All key stakeholders will be invited to participate. The steering group will then hold a consensus meeting to discuss results and form a core outcome set to be introduced and measured. Once core outcomes have been agreed, the next step will be to determine how they should be measured, disseminated, and implemented within an international context.DiscussionThe development, dissemination, and implementation of a core outcome set in TTTS will enable its use in future clinical trials, systematic reviews and clinical practice guidelines. This is likely to advance the quality of research studies and their effective use in order to guide clinical practice and improve patient care, maternal, short-term perinatal outcomes and long-term neurodevelopmental outcomes.Trial registrationCore Outcome Measures in Effectiveness Trials (COMET), 921 Registered on July 2016.International Prospective Register of Systematic Reviews (PROSPERO), CRD42016043999. Registered on 2 August 2016.

A systematic review of primary outcomes and outcome measure reporting in randomized trials evaluating treatments for pre-eclampsia

An evaluation of outcome reporting is required to develop a core outcome set.

Pharmacologic intervention for retained placenta: a systematic review and meta-analysis.

OBJECTIVE: To assess the effectiveness and safety of pharmacologic interventions for the treatment of retained placenta (when the placenta remains undelivered after 30 minutes of active management of the third stage of labor). DATA SOURCES: We searched: 1) Cochrane Central Register of Controlled Trials (CENTRAL), 2) Cochrane Pregnancy and Childbirth Groups Trials Register, 3) EMBASE, and 4) MEDLINE from inception to June 2014. METHODS OF STUDY SELECTION: Randomized controlled trials comparing a pharmacologic intervention(s) with a placebo for the treatment of retained placenta were included. TABULATION, INTEGRATION, AND RESULTS: Sixteen randomized controlled trials, including 1,683 participants, were included. Study characteristics and quality were recorded. The meta-analysis was based on random-effects methods for pooled data. There were no statistically significant differences in the requirement to perform manual removal of a placenta in patients treated with oxytocin (55% compared with 60%; relative risk [RR] 0.86, 95% confidence interval [CI] 0.73–1.02; 10 randomized controlled trials [RCTs]), prostaglandins (44% compared with 55%; RR 0.82, 95% CI 0.58–1.15; four RCTs), nitroglycerin (85% compared with 80%; RR 1.06, 95% CI 0.80–1.41; one RCT), or oxytocin and nitroglycerin (52% compared with 79%; RR 0.23, 95% CI 0.01–8.48; two RCTs) compared with placebo. There was limited reporting of secondary outcomes. CONCLUSION: As opposed to the use of oxytocin as part of the active management of the third stage of labor that has been shown to diminish bleeding in the third stage, once the diagnosis of retained placenta has been made, no pharmacologic treatment has been shown to be effective. When retained placenta is diagnosed, immediate manual removal of the placenta should be considered. SYSTEMATIC REVIEW REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews, http://www.crd.york.ac.uk/PROSPERO/, CRD42014010641.