Using the Delphi Technique to Determine Which Outcomes to Measure in Clinical Trials: Recommendations for the Future Based on a Systematic Review of Existing Studies

Sinha, Ian; Smyth, Rosalind L; Williamson, Paula

doi:10.1371/journal.pmed.1000393

Cited by 699 publications

(838 citation statements)

References 23 publications

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“…11 All key stakeholders including healthcare professionals (anaesthetists, general practitioners, obstetricians, midwives, and neonatologists), researchers, and patients will be invited to participate. There is no robust method for calculating the required sample size but typically groups have included 13 to 222 participants.…”

Section: Stage Two: Determining Core Outcomesmentioning

confidence: 99%

“…There is no robust method for calculating the required sample size but typically groups have included 13 to 222 participants. 11 We aim to recruit a minimum of 18 participants for each stakeholder group (anaesthetists, general practitioners, obstetricians, midwives, neonatologists, researchers, and patients) with balanced representation from high, middle, and low income countries. Before entering the exercise participants will be allocated a unique identifier to anonymise their response.…”

Section: Stage Two: Determining Core Outcomesmentioning

confidence: 99%

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

Duffy

Hooft

Gale

et al. 2016

Pregnancy Hypertension: An International Journal of Women's Car

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Background Pre-eclampsia is a serious complication of pregnancy and contributes to maternal and offspring mortality and morbidity. Randomised controlled trials evaluating therapeutic interventions for pre-eclampsia have reported many different outcomes and outcome measures. Such variation contributes to an inability to compare, contrast, and combine individual studies, limiting the usefulness of research to inform clinical practice. The development and use of a core outcome set would help to address these issues ensuring outcomes important to all stakeholders, including patients, will be collected and reported in a standardised fashion. Methods An international steering group including healthcare professionals, researchers, and patients, has been formed to guide the development of this core outcome set. Potential outcomes will be identified through a comprehensive literature review and semi-structured interviews with patients. Potential core outcomes will be entered into an international, multi-perspective online Delphi survey. All key stakeholders, including healthcare professionals, researchers, and patients will be invited to participate. The modified Delphi method encourages whole and stakeholder group convergence towards consensus ‘core’ outcomes. Once core outcomes have been agreed upon it is important to determine how they should be measured. The truth, discrimination, and feasibility assessment framework will assess the quality of potential outcome measures. High quality outcome measures will be associated with core outcomes. Mechanisms exist to disseminate and implement the resulting core outcome set within an international context. Discussion Embedding the core outcome set within future clinical trials, systematic reviews, and clinical practice guidelines could make a profound contribution to advancing the usefulness of research to inform clinical practice, enhance patient care, and improve maternal and offspring outcomes. The infrastructure created by developing a core outcome set for pre-eclampsia could be leveraged in other settings, for example selecting research priorities and clinical practice guideline development

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Section: Stage Two: Determining Core Outcomesmentioning

confidence: 99%

Section: Stage Two: Determining Core Outcomesmentioning

confidence: 99%

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

Duffy

Hooft

Gale

et al. 2016

Pregnancy Hypertension: An International Journal of Women's Car

View full text Add to dashboard Cite

show abstract

“…The technique is designed as a group exercise that aims to achieve a convergence of opinion that may prove very useful. [8][9][10][11][15][16][17][18][19] The interactions of experts may lead to a reduction in individual bias. The Delphi method is a wellrecognized tool for solving problems in healthcare, and it is increasingly being used to reach consensus around many topics in medicine, including education, development of clinical guidelines, and prioritization of research topics.…”

Section: Discussionmentioning

confidence: 99%

“…The Delphi method is a wellrecognized tool for solving problems in healthcare, and it is increasingly being used to reach consensus around many topics in medicine, including education, development of clinical guidelines, and prioritization of research topics. 16,17 It has been argued that the forecasting accuracy of the Delphi technique is clearly reliable. For example, a Delphi study involving medical doctors evaluating the forecasting application of the method revealed that, in 75% of cases, the estimated values proved to be less than 10% different from the values observed.…”

Section: Discussionmentioning

confidence: 99%

Controversy between anesthesiologists and obstetricians on the labour ward: the Delphi method is used as a consensus-building technique

Nguyen-Lu

Downey

Carvalho

2014

Can J Anesth/J Can Anesth

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“…our views, we used open ended questions (30). In view of the potential use of different terms by different respondents for items that were essentially the same and for subsequent item operationalization, the experts were asked to provide a brief description/meaning of the items and/or proposed measurement approach.…”

Section: Methodsmentioning

confidence: 99%

Pediatric post-thrombotic syndrome in children: Toward the development of a new diagnostic and evaluative measurement tool

Avila

Brandão

Williams

et al. 2016

Thrombosis Research

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Objective: Our goal was to conduct the generation and piloting of a discriminative and evaluative tool for pediatric post-thrombotic syndrome.Methods: We followed a formative model for the development of the tool, focusing on the signs/symptoms (items) that define post-thrombotic syndrome. For item generation, pediatric thrombosis experts and diagnosed with extremity post-thrombotic syndrome during childhood nominated items. In the piloting phase, items were cross-sectionally measured in children with limb deep vein thrombosis to examine the performance of the items.Result: Twenty-three experts and 16 subjects listed 34 items, which were then measured in 140 subjects with previous diagnosis of limb deep vein thrombosis (70 upper extremity and 70 lower extremity). The items with strongest correlation with post-thrombotic syndrome severity and largest area under the curve were pain (in older children), paresthesia, and swollen limb for the upper extremity group, and pain (in older children), tired limb, heaviness, tightness and paresthesia for the lower extremity group.Conclusion: Diagnostic properties and correlation with post-thrombotic syndrome severity of the different signs and symptoms varied according to the assessed venous territory.The information gathered in this study will help experts decide which item should be considered for inclusion in the new tool.

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Using the Delphi Technique to Determine Which Outcomes to Measure in Clinical Trials: Recommendations for the Future Based on a Systematic Review of Existing Studies

Abstract: Ian Sinha and colleagues advise that when using the Delphi process to develop core outcome sets for clinical trials, patients and clinicians be involved, researchers and facilitators avoid imposing their views on participants, and attrition of participants be minimized.

Cited by 699 publications

References 23 publications

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

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

Controversy between anesthesiologists and obstetricians on the labour ward: the Delphi method is used as a consensus-building technique

Pediatric post-thrombotic syndrome in children: Toward the development of a new diagnostic and evaluative measurement tool

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