Our multiphasic study will work toward the development of a core outcome set for postoperative pain management in pediatric patients.
Stage 1
To perform a comprehensive review of the literature including published primary studies and unpublished studies catalogued in clinical trials registries. An informational specialist will assist in the search process using the following databases: PubMed/Medline, Cochrane Central Register of Controlled Trials, and clinicaltrials.gov over a 15 year period. Using these studies, we will produce a comprehensive list of all outcome variables reported across studies as well as the ways in which these outcomes are measured. We will use Saldanha’s et al. (2014) framework to extract the completeness of reported outcomes and the matrix recommended by the ORBIT project to determine the inconsistency of outcomes measured and the potential for outcome reporting bias (Kirkham et al., 2010).
Stage 2
To examine the nature of the outcome found during Stage 1, we will apply social network analysis to the list of outcomes and use centrality measures to determine which outcomes are more centrally located within the network of outcomes (Saldanha, et al., in press).
Stage 3
To further refine our outcomes from Stage 2, we will conduct semi-structured interviews or focus groups of patients who underwent postoperative pain management procedures and anesthesiologists who routinely perform them.
Stage 4
We will perform a Delphi study to arrive at a preliminary set of core outcomes. To assist in the methodological rigor of this stage, we will use Boulkedid, et al., (2011) and other references that discuss best practices when conducting Delphi studies.
Stage 5
We will work with appropriate Cochrane review groups, guideline developers, funding agencies, journal editors, and clinical trials registries to disseminate and increase uptake of our findings.
References:
1. Saldanha, Ian J., et al. "Outcomes in Cochrane systematic reviews addressing four common eye conditions: an evaluation of completeness and comparability." (2014): e109400.
2. Kirkham JJ, Dwan KM, Altman DG, Gamble C, Dodd S, Smyth R, Williamson PR. “The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews”.BMJ (2010),340:c365
3. Saldanha, IJ, Li, T, Yang, C, Ugarte-Gil, C, Rutherford, GW, Dickersin, K. “Social network analysis identified central outcomes for core outcome sets using systematic reviews of HIV/AIDS.” Journal of Clinical Epidemiology (2015), doi: 10.1016/j.jclinepi.2015.08.023.
4. Boulkedid R, Abdoul H, Loustau M, Sibony O, Alberti C. Using and Reporting the Delphi Method for Selecting Healthcare Quality Indicators: A Systematic Review. Wright JM, ed. PLoS ONE. 2011;6(6):e20476. doi:10.1371/journal.pone.0020476
Riley Hedin, MPH
Greg Aran
Alex Demand
Jeff Young
Andrew Ross
Matt Vassar, PhD
Jody Worley, PhD
Disease Category: Anaesthesia & pain control
Disease Name: Postoperative pain
Age Range: 0 - 18
Sex: Either
Nature of Intervention: Postoperative management
- Clinical experts
- Consumers (patients)
- Methodologists
- Researchers
- Statisticians
- Trialists
- COS for clinical trials or clinical research
- Systematic review of outcomes measured in trials
- Delphi process
- Interview
- Other
- Systematic review
1. A systematic review of the literature on postoperative pain management in pediatric patients will be performed using Pubmed, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov to identify relevant studies from the previous 15 years.
2. Social network analysis of published outcomes will allow identification of outcomes most central to the network.
3. Semi-structured interviews with patients and anesthesiologists will be conducted to identify additional outcomes from these key stakeholders.
4. A Delphi study will be used to refine the list of outcomes.