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

Whitehouse, Katherine; Kim, Caron; Ganatra, Bela; Duffy, James M N; Blum, Jennifer; Brahmi, Dalia; Creinin, Mitchell D.; DePiñeres, Teresa; Gemzell‐Danielsson, Kristina; Grossman, Daniel; Winikoff, Beverly; Gülmezoglu, A. Metin

doi:10.1016/j.contraception.2016.12.009

Cited by 39 publications

(44 citation statements)

References 17 publications

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“…Seven published protocols were identified: endometriosis, termination of pregnancy, pre‐eclampsia, diabetes in pregnancy, neonatal abstinence syndrome, gastroschisis, and autologous fat grafting (Table S1). The protocols were published in 2015 ( n = 1), 2016 ( n = 5), or January 2017 ( n = 1). Five protocols described core outcome sets funded by international funders, World Health Organization, national funders, including Health Research Board (Ireland), National Institute of Health Research (UK), and Royal College of Obstetricians and Gynaecologists (UK), or regional funders such as Barts Health Charity (London, UK) .…”

Section: Resultsmentioning

confidence: 99%

“… The protocols were published in 2015 ( n = 1), 2016 ( n = 5), or January 2017 ( n = 1). Five protocols described core outcome sets funded by international funders, World Health Organization, national funders, including Health Research Board (Ireland), National Institute of Health Research (UK), and Royal College of Obstetricians and Gynaecologists (UK), or regional funders such as Barts Health Charity (London, UK) . The scope of the core outcome set was clearly stated in five protocols .…”

Section: Resultsmentioning

confidence: 99%

“…All protocols described systematic reviews to identify potential core outcomes. Additionally, three protocols described linked qualitative research methods, including a systematic review of qualitative research and qualitative patient interviews . All protocols intended to identify core outcomes using a modified Delphi method and in addition six protocols intended to organise a consensus development meeting.…”

Section: Resultsmentioning

confidence: 99%

See 2 more Smart Citations

Core outcome sets in women's and newborn health: a systematic review

Duffy

Rolph

Gale

et al. 2017

BJOG

140

165

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Core outcome sets in women's and newborn health: a systematic review

Duffy

Rolph

Gale

et al. 2017

BJOG

140

165

View full text Add to dashboard Cite

show abstract

“…A core outcome set would help to address these issues . Core outcome sets are being developed across women's health, including pre‐eclampsia, endometriosis, and infertility . A core outcome set for POP is currently under way, we would recommend as an interim consensus the use of a short list of the most commonly reported outcomes based on our findings as a minimum set.…”

Section: Discussionmentioning

confidence: 99%

A systematic review on reporting outcomes and outcome measures in trials on synthetic mesh procedures for pelvic organ prolapse: Urgent action is needed to improve quality of research

Lourenço¹,

Pergialiotis

Duffy

et al. 2018

Neurourology and Urodynamics

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The use of synthetic mesh in pelvic organ prolapse surgery is being closely scrutinized because of serious concerns regarding life‐changing complications such as erosion, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems. Randomized trials and their syntheses in meta‐analysis offer a unique opportunity to assess efficacy and safety. However, outcomes and outcome measures need to be consistently selected, collected, and reported across randomized trials to be effectively combined in systematic reviews. Aims We evaluated outcome and outcome measure reporting across randomized controlled trials on surgical interventions using synthetic mesh for pelvic organ prolapse. Methods Systematic review of randomized controlled trials using synthetic mesh for the treatment of pelvic organ prolapse. The selected studies were evaluated using Jadad and MOMENT criteria. Outcomes and outcome measures were systematically identified and categorized. Results Seventy‐one randomized trials were included. Twenty‐four different types of mesh were identified. Included trials reported 110 different outcomes and 60 outcome measures. Erosion (40 trials, 78%), pain (29 trials, 56%), bleeding (31 trials, 61%), and dyspareunia (25 trials, 49%) were the most frequently reported outcomes. The longest follow up was 74 months. Conclusions Most randomized trials evaluating surgical interventions using synthetic mesh for pelvic organ prolapse failed to report on clinically important outcomes and to evaluate efficacy and safety over the medium‐ and long‐term. Developing and implementing a minimum data set, known as a core outcome set, in future vaginal prolapse trials could help address these issues.

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“…Our primary outcomes were success rate and safety for women, and acceptability for women or providers. We thereby adhered to the core outcome sets for medical abortion that are being formulated . We defined success rate as any measure of complete abortion, safety as any measure of abortion‐related complications severely affecting the physical health of the woman, and quantitative acceptability for women or providers as any categorical measure of the emotional experience of performing or providing medical abortion through TM.…”

Section: Methodsmentioning

confidence: 99%

Telemedicine for medical abortion: a systematic review

Endler

Lavelanet

Cleeve

et al. 2019

BJOG

175

179

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Background Telemedicine is increasingly being used to access abortion services. Objective To assess the success rate, safety, and acceptability for women and providers of medical abortion using telemedicine. Search strategy We searched PubMed, EMBASE, ClinicalTrials.gov, and Web of Science up until 10 November 2017. Study criteria We selected studies where telemedicine was used for comprehensive medical abortion services, i.e. assessment/counselling, treatment, and follow up, reporting on success rate (continuing pregnancy, complete abortion, and surgical evacuation), safety (rate of blood transfusion and hospitalisation) or acceptability (satisfaction, dissatisfaction, and recommendation of the service). Data collection and analysis Quantitative outcomes were summarised as a range of median rates. Qualitative data were summarised in a narrative synthesis. Main results Rates relevant to success rate, safety, and acceptability outcomes for women ≤10+0 weeks’ gestation (GW) ranged from 0 to 1.9% for continuing pregnancy, 93.8 to 96.4% for complete abortion, 0.9 to 19.3% for surgical evacuation, 0 to 0.7% for blood transfusion, 0.07 to 2.8% for hospitalisation, 64 to 100% for satisfaction, 0.2 to 2.3% for dissatisfaction, and 90 to 98% for recommendation of the service. Rates in studies also including women >10+0 GW ranged from 1.3 to 2.3% for continuing pregnancy, 8.5 to 20.9% for surgical evacuation, and 90 to 100% for satisfaction. Qualitative studies on acceptability showed no negative impacts for women or providers. Conclusion Based on a synthesis of mainly self‐reported data, medical abortion through telemedicine seems to be highly acceptable to women and providers, success rate and safety outcomes are similar to those reported in literature for in‐person abortion care, and surgical evacuation rates are higher. Tweetable abstract A systematic review of medical abortion through telemedicine shows outcome rates similar to in‐person care.

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

Cited by 39 publications

References 17 publications

Core outcome sets in women's and newborn health: a systematic review

Core outcome sets in women's and newborn health: a systematic review

A systematic review on reporting outcomes and outcome measures in trials on synthetic mesh procedures for pelvic organ prolapse: Urgent action is needed to improve quality of research

Telemedicine for medical abortion: a systematic review

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