Outcome domains and pain outcome measures in randomized controlled trials of interventions for postoperative pain in children and adolescents

Borić, Krste; Kadić, Antonia Jeličić; Borić, Matija; Zarandi‐Nowroozi, Melissa; Jakus, Dora; Ćavar, Marija; Došenović, Svjetlana; Jerić, Milka; Batinic, Marijan; Vukovic, Igor; Puljak, Livia

doi:10.1002/ejp.1313

Cited by 20 publications

(20 citation statements)

References 14 publications

(24 reference statements)

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“…Several studies compared the use of the outcomes that the COS recommended before and after the publication of the COS [17,19,29]. Only one of these studies, which assessed a COS for ankylosing spondylitis, noted some increase in uptake of the full COS after publication (0% RCTs before versus 20% RCTs after).…”

Section: Discussionmentioning

confidence: 99%

“…They extracted data about the outcomes included from the RCT reports and SRs. Two (8%) studies searched SRs to identify RCTs [28,29], and one (4%) study included RCTs identified from one systematic review [30]. Five (19%) studies identified RCTs by searching in a clinical trials registry [31e35].…”

Section: Methods Used To Assess Uptakementioning

confidence: 99%

“…A further 15 studies suggested potential barriers that may have resulted in low uptake of the COS (Table 3). The absence of validated measures, or no consensus on which instruments should be used to assess the domains, was noted in four studies [11,25,26,29]. Six studies referred to a limited patient or other key stakeholder involvement in the development of the COS as a potential barrier to uptake.…”

Section: Suggested Barriers To Uptake Of Cosmentioning

confidence: 99%

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A systematic review finds Core Outcome Set uptake varies widely across different areas of health

Hughes

Clarke

Williamson

2021

Journal of Clinical Epidemiology

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The aim of our review was to bring together studies that had assessed the uptake of core outcome sets (COS) to explore the level of uptake across different COS and areas of health. Study Design and Setting: We examined the citations of 337 COS reports to identify studies that had assessed the uptake of a particular COS in randomized controlled trials (RCTs) or systematic reviews (SRs). Results: We identified 24 studies that had assessed uptake in RCTs and two studies that had assessed uptake in SRs. The studies covered a total of 17/337 (5%) COS. Uptake rates reported for RCTs varied from 0% of RCTs (gout) to 82% RCTs (rheumatoid arthritis) measuring the full COS. Studies that assessed uptake of individual core outcomes showed a wide variation in uptake between the outcomes. Suggested barriers to uptake included lack of validated measures, lack of patient and other key stakeholder involvement in COS development, and lack of awareness of the COS. Conclusions: Few studies have been undertaken to assess the uptake of COS in RCTs and SRs. Further studies are needed to assess whether COS have been implemented across a wider range of disease categories and to explore the barriers and facilitators to COS uptake.

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Section: Discussionmentioning

confidence: 99%

Section: Methods Used To Assess Uptakementioning

confidence: 99%

Section: Suggested Barriers To Uptake Of Cosmentioning

confidence: 99%

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A systematic review finds Core Outcome Set uptake varies widely across different areas of health

Hughes

Clarke

Williamson

2021

Journal of Clinical Epidemiology

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“…In a study of 337 trials, which analyzed outcome domains and pain outcome measures in randomized controlled trials (RCTs) of interventions for treatment of postoperative pain in children and adolescents and compared them with recommendations of the PedIMMPACT, it was found that the median number of outcomes reported in RCTs was 2 for PedIMMPACT outcomes (range, 0 to 6) (7).…”

Section: Adherence To Cos and Coms In Clinical Trialsmentioning

confidence: 99%

Pain assessment in clinical trials: a narrative review

2021

Self Cite

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Pain is a symptom measured in many clinical trials. For pain as an outcome domain, trialists need to choose adequate outcome measure(s), as there are myriad outcome measures for pain to choose from. To ensure consistency and uniformity in clinical trials and systematic reviews, core outcome sets (COS) have been defined; COS includes a predefined minimal list of core outcomes that should be measured within a trial, to ensure their consistency and comparability. COS is defined via consensus procedure, which includes relevant stakeholders such as experts from a specific field and patients. Along with outcomes, outcome measures for each outcome need to be defined to make sure that the outcomes will be measured consistently and uniformly. Hereby we reviewed studies that have examined use of recommended core outcome domains and outcome measures in clinical trials that would be expected to measure pain. Despite the existence of COS and defined core outcome measures (COMs), multiple studies have shown that these are not necessarily used in clinical trials, or in the relevant systematic reviews, which further increases heterogeneity of existing evidence, hinders evidence synthesis and trial comparability, and assessment of comparative effectiveness of interventions. Trialists are encouraged to use COS and COMs when designing clinical trials. Research community is encouraged to design interventions that will help with identifying barriers for using COS and COMs and interventions to foster their uptake. Use of consistent pain outcomes and pain outcome measures is in the interest of patients, research community, healthcare workers and decision-makers. For clinical conditions for which there are no COS and COMs, efforts to design them would be beneficial.

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“…36,56 Consistent with the biopsychosocial model, 18 a more comprehensive assessment of pain has been recommended, 38 including pain intensity, satisfaction and treatment response, side effects, pain interference, emotional response, and economic factors. However, pediatric pain research rarely includes all recommended domains of pain assessment, 7 possibly due to the lack of validated, comprehensive measures. Several multidimensional measures of pediatric pain have been developed, but only 4 have been found to have adequate psychometric properties.…”

mentioning

confidence: 99%

The Pediatric American Pain Society Patient Outcomes Questionnaire (Pediatric APS-POQ): Development and Initial Psychometric Evaluation of a Brief and Comprehensive Measure of Pain and Pain Outcomes in Hospitalized Youth

Kaczynski

Ely

Gordon

et al. 2020

The Journal of Pain

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Outcome domains and pain outcome measures in randomized controlled trials of interventions for postoperative pain in children and adolescents

Abstract: Recommended core outcomes have been insufficiently used in randomized controlled trials about postoperative pain in children, which hinders comparability of studies and makes synthesis of evidence difficult.

Cited by 20 publications

References 14 publications

A systematic review finds Core Outcome Set uptake varies widely across different areas of health

A systematic review finds Core Outcome Set uptake varies widely across different areas of health

Pain assessment in clinical trials: a narrative review

The Pediatric American Pain Society Patient Outcomes Questionnaire (Pediatric APS-POQ): Development and Initial Psychometric Evaluation of a Brief and Comprehensive Measure of Pain and Pain Outcomes in Hospitalized Youth

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