CORE-Kids: a protocol for the development of a core outcome set for childhood fractures

Marson, Ben; Manning, Joseph C; James, Marilyn; Craxford, Simon; Deshmukh, Sandeep R.; Ollivere, B.

doi:10.1136/bmjopen-2019-036224

Cited by 11 publications

(7 citation statements)

References 47 publications

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“…12 , 13 Study reporting is consistent with the COS-STAR guidelines (Supplementary Material). 14 As stated in the study protocol, 15 the scope of this core outcome set was set by the steering group in collaboration with the National Institute for Health Research (NIHR) trauma trials network as: Setting: research studies; Health condition: fractures to the appendicular skeleton (i.e. limbs, pelvis, and shoulder girdle but not spine, ribs, or head) excluding children with multiple injuries.…”

Section: Methodsmentioning

confidence: 99%

“…Detailed methods have been published elsewhere. 15 In brief, children with fractures were sampled from outpatient clinics with purposeful sampling to generate a diverse group of ages, fracture types, and experience of different treatments. Interviews were conducted and recorded by researchers trained in qualitative methods and analyzed using a content analysis.…”

Section: Methodsmentioning

confidence: 99%

“…A pre-specified threshold of > 70% was set for outcomes to be included in the core set. 15 A sensitivity analysis was performed to identify the effect of the majority stakeholder group by first removing the scores of surgeons and then exclusively including scores of partners and patients.…”

Section: Methodsmentioning

confidence: 99%

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Development of the CORE-Kids core set of outcome domains for studies of childhood limb fractures

Marson

Manning

James

et al. 2021

The Bone & Joint Journal

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Aims The aim of this study is to develop a core set of outcome domains that should be considered and reported in all future trials of childhood limb fractures. Methods A four-phase study was conducted to agree a set of core outcome domains. Identification of candidate outcome domains were identified through systematic review of trials, and outcome domains relevant to families were identified through semi-structured interviews with 20 families (parent-child pairing or group). Outcome domains were prioritized using an international three-round Delphi survey with 205 panellists and then condensed into a core outcome set through a consensus workshop with 30 stakeholders. Results The systematic review and interviews identified 85 outcome domains as relevant to professionals or families. The Delphi survey prioritized 30 upper and 29 lower limb outcome domains at first round, an additional 17 upper and 18 lower limb outcomes at second round, and four additional outcomes for upper and lower limb at the third round as important domains. At the consensus workshop, the core outcome domains were agreed as: 1) pain and discomfort; 2) return to physical and recreational activities; 3) emotional and psychosocial wellbeing; 4) complications from the injury and treatment; 5) rturn to baseline activities daily living; 6) participation in learning; 7) appearance and deformity; and 8) time to union. In addition, 9a) recovery of mobility and 9b) recovery of manual dexterity was recommended as a core outcome for lower and upper limb fractures, respectively. Conclusion This set of core outcome domains is recommended as a minimum set of outcomes to be reported in all trials. It is not an exhaustive set and further work is required to identify what outcome tools should be used to measure each of these outcomes. Adoption of this outcome set will improve the consistency of research for these children that can be combined for more meaningful meta-analyses and policy development.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Development of the CORE-Kids core set of outcome domains for studies of childhood limb fractures

Marson

Manning

James

et al. 2021

The Bone & Joint Journal

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“…The Delphi method is a well-established method for achieving formal consensus [ 46 , 47 ]. This method has been used to reach consensus on core domains for different health conditions such as low back pain [ 48 ], shoulder disorders [ 41 ], and childhood fractures [ 49 ]. Using an online survey permits the involvement of a large number of participants from geographically distant locations, protects the anonymity of participant responses, and avoids the effect of overly vocal or dominant individuals [ 27 ].…”

Section: Consensus Processmentioning

confidence: 99%

Protocol for the development of a core domain set for individuals with ankle osteoarthritis

Alanazi

Vicenzino

Bergen

et al. 2022

Trials

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Background Ankle osteoarthritis (OA) is a debilitating health condition that is increasing in prevalence. Currently, there are no evidence-based guidelines for managing ankle OA. One of the current challenges to establishing guidelines is the lack of a widely agreed-upon set of outcome measures that are consistently used in ankle OA research. Without a set of agreed-upon outcome measures, it is difficult to synthesise clinical trial outcomes through meta-analysis—an essential element of evidence-informed practice. In order to develop an appropriate set of outcome measures for ankle OA, it is important first to develop a core domain set. In this protocol, we describe the methodological approach that we will use to develop such a core domain set for ankle OA. Methods We established an international steering committee to guide the development of a core domain set for ankle OA. The core domain set development will follow a multi-staged approach consisting of three phases, involving participation by patients and clinicians/healthcare professionals. In phase 1, a list of candidate domains will be gleaned from (a) a scoping review of outcome measures used in ankle OA research, (b) qualitative interviews with individuals with ankle OA, and (c) qualitative interviews with healthcare professionals with expertise in ankle OA. In phase 2, the steering committee will review and generate a list of candidate domains from those gleaned in phase 1. In phase 3, this list of candidate domains will be considered in a Delphi process to reach a consensus on a core domain set. We anticipated this will involve 3 rounds of surveys. Conclusion This protocol describes the methods that will be used to develop a core domain set of health-related aspects for ankle OA. Importantly, it will include both healthcare professional and patient involvement. This is a prerequisite step to developing a core outcome set for ankle OA that should be reported in all clinical trials for ankle OA. The findings will be widely disseminated across peer-refereed publication(s) and national and international conferences, as well as via relevant professional societies, patient support group organisations, and social media platforms. Project registration This project is registered with the Core Outcome Measures in Effectiveness Trials (COMET) database on 17 March 2021. https://www.comet-initiative.org/Studies/Details/1837.

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“…The need for a core outcome set for distal tibia and ankle fractures is clear and has been recently recommended to increase outcome reporting homogeneity in ankle fracture research [ 21 ]. Currently, there is work ongoing to develop a core outcome set for ankle fractures specifically for children [ 22 ] but no guidance for adults.…”

Section: Introductionmentioning

confidence: 99%

Co-producing a multi-stakeholder Core Outcome Set for distal Tibia and Ankle fractures (COSTA): a study protocol

Pearson

Tutton

Joeris

et al. 2021

Trials

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Background Ankle fracture is a common injury with a strong evidence base focused on effectiveness of treatments. However, there are no reporting guidelines on distal tibia and ankle fractures. This has led to heterogeneity in outcome reporting and consequently, restricted the contribution of evidence syntheses. Over the past decade, core outcome sets have been developed to address this issue and are available for several common fractures, including those of the hip, distal radius, and open tibial fractures. This protocol describes the process to co-produce—with patient partners and other key stakeholders—a multi-stakeholder derived Core Outcome Set for distal Tibia and Ankle fractures (COSTA). The scope of COSTA will be for clinical trials. Methods The study will have five-stages which will include the following: (i) systematic reviews of existing qualitative studies and outcome reporting in randomised controlled trial studies to inform a developing list of potential outcome domains; (ii) qualitative interviews (including secondary data) and focus groups with patients and healthcare professionals to explore the impact of ankle fracture and the outcomes that really matter; (iii) generation of meaningful outcome statements with the study team, international advisory group and patient partners; (iv) a multi-round, international e-Delphi study to achieve consensus on the core domain set; and (v) an evidence-based consensus on a core measurement set will be achieved through a structured group consensus meeting, recommending best assessment approaches for each of the domains in the core domain set. Discussion Development of COSTA will provide internationally endorsed outcome assessment guidance for clinical trials for distal tibia and ankle fractures. This will enhance comparative reviews of interventions, potentially reducing reporting bias and research waste.

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CORE-Kids: a protocol for the development of a core outcome set for childhood fractures

Cited by 11 publications

References 47 publications

Development of the CORE-Kids core set of outcome domains for studies of childhood limb fractures

Development of the CORE-Kids core set of outcome domains for studies of childhood limb fractures

Protocol for the development of a core domain set for individuals with ankle osteoarthritis

Co-producing a multi-stakeholder Core Outcome Set for distal Tibia and Ankle fractures (COSTA): a study protocol

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