A core outcome set for future research in ectopic pregnancy: an international consensus development study

Chong, Krystle Y.; Solangon, Sarah; Barnhart, Kurt T.; Causa-Andrieu, Pamela; Capmas, P.; Condous, G.; Waard, Liesl de; Duffy, James M.N.; Horne, Andrew; Memtsa, Maria; Mol, Femke; Oza, Munira; Pesce, Romina; Strandell, Annika; Wely, Madelon van; Hooft, Janneke van ’t; Vuong, Lan N.; Zhang, Jian; Mol, Ben Willem

doi:10.1016/j.fertnstert.2023.01.042

Cited by 6 publications

(4 citation statements)

References 20 publications

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“…Whilst future research and quality assurance projects are merited to assess cost-effectiveness, patient and clinician satisfaction and strategies to help both groups, these models add minimal financial burden, provide an objective tool to support women and healthcare professionals, and can be used as part of a two-step strategy (Figure 1) 19,20,42 . Clinical factors can be collected routinely, most units already use serial β-hCG monitoring (with or without progesterone measurement), and Step 1 of the two-step strategy safely reduces the number of 48-h reviews required 19,20 .…”

Section: Discussionmentioning

confidence: 99%

Updating M6 pregnancy of unknown location risk‐prediction model including evaluation of clinical factors

Kyriacou,

Ledger,

Bobdiwala

et al. 2024

Ultrasound in Obstet & Gyne

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IntroductionEctopic pregnancy (EP) is the major high‐risk outcome following a pregnancy of unknown location (PUL) classification. Biochemical markers are used to triage PUL to high versus low risk to decide appropriate follow up. The M6 model is currently the best risk prediction model. We aimed to update the M6 model and evaluate whether the model can be improved by including clinical factors.MethodsThis prospective cohort study recruited consecutive PUL between January 2015 and January 2017 (phase one) at eight units, with two center recruitment between January 2017 and March 2021 (phase two). Serum samples were routinely collected and sent for BhCG and progesterone measurement. Clinical factors recorded were maternal age, pain score, bleeding score and history of previous EP. Based on transvaginal ultrasonography and/or biochemical confirmation during follow‐up, PUL were subsequently classified as failed PUL, intrauterine pregnancy, or EP (including persistent PUL (PPUL)). The M6 models with (M6P) and without progesterone (M6NP) were refitted and extended with clinical factors. Model validation was performed using internal‐external cross validation (IECV ‐ phase one), and external validation (EV ‐ phase two). Missing values were handled using multiple imputation.Results5473 PUL were recruited over both phases. 709 PUL were excluded because maternal age was <16 years or initial BhCG was ≤25 IU/L, leaving 4764 (86%) PUL for analysis (2894 in phase one, 1870 in phase 2). For the refitted M6P, the area under the receiver operating characteristic curve (AUROC) for EP/PPUL vs other was 0.89 for IECV and 0.84‐0.88 with EV. For the refitted M6NP, the AUROC was 0.85 for IECV and 0.82‐0.86 with EV. Calibration performance was good overall, but with heterogeneity between centers. Net Benefit confirmed clinical utility. The change in AUROC when extending M6P with maternal age, bleeding score, and EP history was ‐0.02 to 0.01 depending on center and phase. The change in AUROC when extending M6NP was ‐0.01 to 0.03. At the 5% threshold defining high EP/PPUL risk, extending M6P altered sensitivity by ‐0.02 to ‐0.01, specificity by 0.03 to 0.04, and Net Benefit by ‐0.005 to 0.006. Extending M6NP altered sensitivity by ‐0.03 to ‐0.01, specificity by 0.05 to 0.07, and Net Benefit by ‐0.005 to 0.006.ConclusionsThe updated M6 model offers accurate diagnostic performance, with excellent sensitivity for EP. Adding clinical factors to the model improves performance in some centers, especially when progesterone levels are not suitable or unavailable.This article is protected by copyright. All rights reserved.

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Section: Discussionmentioning

confidence: 99%

Updating M6 pregnancy of unknown location risk‐prediction model including evaluation of clinical factors

Kyriacou,

Ledger,

Bobdiwala

et al. 2024

Ultrasound in Obstet & Gyne

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“…Our IPD‐MA highlights the need to standardize outcome definitions and reporting to compare studies more effectively. The recent development of a core outcome set for treatment of ectopic pregnancies for future investigators will enable this 43 . All future studies should state clear diagnostic criteria for an EP to eliminate uncertainty as to what condition is being treated, whether a true tubal EP or a PUL, the latter of which could be a miscarriage or live normally sited pregnancy too small to visualize on ultrasound scan.…”

Section: Discussionmentioning

confidence: 99%

“…The recent development of a core outcome set for treatment of ectopic pregnancies for future investigators will enable this. 43 All future studies should state clear diagnostic criteria for an EP to eliminate uncertainty as to what condition is being treated, whether a true tubal EP or a PUL, the latter of which could be a miscarriage or live normally sited pregnancy too small to visualize on ultrasound scan. Advances in ultrasound have enabled accurate detection of tubal EP with studies demonstrating high sensitivity, specificity and positive predictive values 2 , 44 , 45 , 46 and we should therefore define tubal EP as a scan diagnosis.…”

Section: Discussionmentioning

confidence: 99%

Methotrexate vs expectant management for treatment of tubal ectopic pregnancy: An individual participant data meta‐analysis

Solangon

Wely

Mello

et al. 2023

Acta Obstet Gynecol Scand

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IntroductionEctopic pregnancy is an important health condition which affects up to 1 in 100 women. Women who present with mild symptoms and low serum human chorionic gonadotrophin (hCG) are often treated with methotrexate (MTX), but expectant management with close monitoring is a feasible alternative. Studies comparing the two treatments have not shown a statistically significant difference in uneventful resolution of ectopic pregnancy, but these studies were too small to define whether certain subgroups could benefit more from either treatment.Material and methodsWe performed a systematic review and individual participant data meta‐analysis (IPD‐MA) of randomized controlled trials comparing systemic MTX and expectant management in women with tubal ectopic pregnancy and low hCG (<2000 IU/L). A one‐stage IPD‐MA was performed to assess overall treatment effects of MTX and expectant management to generate a pooled intervention effect. Subgroup analyses and exploratory multivariable analyses were undertaken according to baseline serum hCG and progesterone levels. Primary outcome was treatment success, defined as resolution of clinical symptoms and decline in level of serum hCG to <20 IU/L, or a negative urine pregnancy test by the initial intervention strategy, without any additional treatment. Secondary outcomes were need for blood transfusion, surgical intervention, additional MTX side‐effects and hCG resolution times. Trial registration number: PROSPERO: CRD42021214093.Results1547 studies reviewed and 821 remained after duplicates removed. Five studies screened for eligibility and three IPD requested. Two randomized controlled trials supplied IPD, leading to 153 participants for analysis. Treatment success rate was 65/82 (79.3%) after MTX and 48/70 (68.6%) after expectant management (IPD risk ratio [RR] 1.16, 95% confidence interval [CI] 0.95–1.40). Surgical intervention rates were not significantly different: 8/82 (9.8%) vs 13/70 (18.6%) (RR 0.65, 95% CI 0.23–1.14). Mean time to success was 19.7 days (95% CI 17.4–22.3) after MTX and 21.2 days (95% CI 17.8–25.2) after expectant management (P = 0.25). MTX specific side‐effects were reported in 33 MTX compared to four in the expectant group.ConclusionsOur IPD‐MA showed no statistically significant difference in treatment efficacy between MTX and expectant management in women with tubal ectopic pregnancy with low hCG. Initial expectant management could be the preferred strategy due to fewer side‐effects.

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“…Participants were invited nationwide through the professional contacts of the leading investigator. Guided by the established core outcome set methodology, [16] we aimed to recruit at least 30 participants from each key stakeholder group, with critical consideration including experts with a deep understanding of the project. Therefore, in addition to considering stakeholder inclusion, we formulated the criteria for optimal representation.…”

Section: Participantsmentioning

confidence: 99%

Core outcome set for clinical trials of stent implantation in coronary heart disease -- a systematic review and mixed-method consensus study

Wan,

Wang,

et al. 2024

Preprint

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BackgroundAlthough various types of stent interventions have been found in clinical trials to be effective in treating coronary heart disease, researchers often use heterogeneous outcome measures. This can preclude the comparison of results across studies and prevent effective meta-analyses from answering important clinical questions. The need to standardize outcome measure reporting is urgent. This study aims to produce a core outcome set(COS) for coronary stent implantation research.MethodsWe performed a systematic review via the PubMed and EMBASE databases and then synthesized recommendations from international standardized endpoint definitions and consensus documents to generate a list of potential outcomes. We conducted a two-round Delphi survey, achieving the iterative selection of potential outcomes. A multidisciplinary panel of experts and patients with coronary stent implantation experience rated the importance of candidate outcomes on a 9-point Likert scale. To be provisionally accepted, outcomes needed to be critical important (score 7-9, with 9 being the maximum) by 70% of each stakeholder group. Finally, we held a consensus meeting to discuss and generate the COS.ResultsA total of seventy-two potential outcomes were identified by systematic literature review. We obtained nine key consensus documents to inform the standardized definitions of the outcomes. After duplication and combination of similar outcomes, 26 of the 72 outcomes assigned into five outcome domains were included in the Delphi surveys. Twenty outcomes were provisionally accepted. Following the consensus meetings, the agreement was reached on a twelve-item COS.ConclusionWe developed a COS for coronary stent implantation in coronary heart disease. Its implementation will facilitate the standardization reporting of clinical trials and reduce the heterogeneity in assessment in future research. Further research may help determine the specific, validated measurement instruments to assess each outcome.What is KnownCoronary stent implantation is consider to be the primary method for treating coronary heart disease.Many trials use heterogeneous effectiveness and safety outcome measures with different defined and non-patient concerned outcome measures, which would largely prevent meta-analyses and contribute to selective reporting bias.What the Study AddsWe initially develop the first core outcome set(COS) of coronary stent implantation intervention for China to facilitate the standardization reporting of clinical trials and enable meta-analysis.In our study, patient concerned outcome measure were thoroughly discussed and included in the COS by extensively involved patient representatives in every step of the project.Although we used rigorous method to development the COS, it should be updated as new evidence emerges in this rapidly evolving field.

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A core outcome set for future research in ectopic pregnancy: an international consensus development study

Cited by 6 publications

References 20 publications

Updating M6 pregnancy of unknown location risk‐prediction model including evaluation of clinical factors

Updating M6 pregnancy of unknown location risk‐prediction model including evaluation of clinical factors

Methotrexate vs expectant management for treatment of tubal ectopic pregnancy: An individual participant data meta‐analysis

Core outcome set for clinical trials of stent implantation in coronary heart disease -- a systematic review and mixed-method consensus study

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