A protocol for developing, disseminating, and implementing a core outcome set for pre-eclampsia

Duffy, James M N; Hooft, Janneke van ’t; Gale, Chris; Brown, Mark; Grobman, William A.; Fitzpatrick, Ray; Karumanchi, S. Ananth; Lucas, Nuala; Magee, Laura A.; Mol, Ben Willem; Stark, Michael J.; Thangaratinam, Shakila; Wilson, Mathew J.; Dadelszen, Peter von; Williamson, Paula; Khan, Khalid S.; Ziébland, Sue; McManus, Richard J

doi:10.1016/j.preghy.2016.04.008

Cited by 49 publications

(51 citation statements)

References 16 publications

(32 reference statements)

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“…Of these 37, 21 planned to use both interviews and focus groups. Of the planned and ongoing studies five have published protocols [75–79]. Overall this supports the findings in Gorst’s [80] recently updated systematic review which reports the increase in COS development studies and the increasing involvement of patients and carers.…”

Section: Resultssupporting

confidence: 71%

A review of patient and carer participation and the use of qualitative research in the development of core outcome sets

Jones

Keeley

et al. 2017

PLoS ONE

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BackgroundTo be meaningful, a core outcome set (COS) should be relevant to all stakeholders including patients and carers. This review aimed to explore the methods by which patients and carers have been included as participants in COS development exercises and, in particular, the use and reporting of qualitative methods.MethodsIn August 2015, a search of the Core Outcomes Measures in Effectiveness Trials (COMET) database was undertaken to identify papers involving patients and carers in COS development. Data were extracted to identify the data collection methods used in COS development, the number of health professionals, patients and carers participating in these, and the reported details of qualitative research undertaken.ResultsFifty-nine papers reporting patient and carer participation were included in the review, ten of which reported using qualitative methods. Although patients and carers participated in outcome elicitation for inclusion in COS processes, health professionals tended to dominate the prioritisation exercises. Of the ten qualitative papers, only three were reported as a clear pre-designed part of a COS process. Qualitative data were collected using interviews, focus groups or a combination of these. None of the qualitative papers reported an underpinning methodological framework and details regarding data saturation, reflexivity and resource use associated with data collection were often poorly reported. Five papers reported difficulty in achieving a diverse sample of participants and two reported that a large and varied range of outcomes were often identified by participants making subsequent rating and ranking difficult.ConclusionsConsideration of the best way to include patients and carers throughout the COS development process is needed. Additionally, further work is required to assess the potential role of qualitative methods in COS, to explore the knowledge produced by different qualitative data collection methods, and to evaluate the time and resources required to incorporate qualitative methods into COS development.

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Section: Resultssupporting

confidence: 71%

A review of patient and carer participation and the use of qualitative research in the development of core outcome sets

Jones

Keeley

et al. 2017

PLoS ONE

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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%

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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“…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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A protocol for developing, disseminating, and implementing a core outcome set for pre-eclampsia

Cited by 49 publications

References 16 publications

A review of patient and carer participation and the use of qualitative research in the development of core outcome sets

A review of patient and carer participation and the use of qualitative research in the development of core outcome sets

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

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