Our multiphasic study will work toward the development of a core outcome set for pediatric acute lymphoblastic leukemia.
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To perform a comprehensive review of the literature including published primary studies and unpublished studies catalogued in clinical trials registries.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 ten 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 the aforementioned procedures and oncologists 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.
Contributors: David Herrmann, Tim Nissen, Will Blaik, Cole Wayant, Jordan Wiebe, Matt Vassar, Ph.D.
Disease Category: Cancer
Disease Name: Acute lymphoblastic leukemia
Age Range: 0 - 18
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Methodologists
- Other
- Statisticians
- COS for clinical trials or clinical research
- Delphi process
- Interview
- Other
- Systematic review
1. A systematic review of the literature on acute lymphoblastic leukemia will be performed using Pubmed, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov to identify relevant studies from the previous 10 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 oncologists will be conducted to identify additional outcomes from these key stakeholders.
4. A Delphi study will be used to refine the list of outcomes.
Other stakeholders: Cochrane reviewers
Clinical trials registry representatives