Characteristics of Clinical Trials included in the Registry
- Randomized Controlled Clinical trials
- Enrolling at least 50 patients overall
- Having included a Patient-Reported Outcome (PRO) component
- Published since January 2004
Evidence Acquisition
Published papers meeting the above reported criteria are mainly searched through the following electronic databases: PubMed/Medline and the Cochrane library.
Methods of evaluation of studies
After having verified eligibility of articles, at least two reviewers (i.e., study collaborators) independently review and extract several information. Each reviewer has a personal password to access the online system and can complete the electronic-data extraction form (eDEF). This approach allows a double blind data entry procedure to ensure the highest possible quality data collection in the PROMOTION Registry. Discrepancies in the two evaluations are recorded and a discrepancy Form is electronically generated by the data collection system. On the basis of this discrepancy Form the two reviewers discuss each issue by revisiting the paper to reconcile any differences. When consensus is achieved on each single variable, a final eDEF (for that specific article) is then locked, validated and imputed in the PROMOTION database.
Type of information included for each study
More than 50 different information (i.e., variables) are included in the eDEF. Data extracted for each RCT includes:
1. Basic trial demographics and clinical and PRO characteristics (e.g., number of patients enrolled, study location, treatments being compared, PRO instrument used, clinical and PRO assessments);
2. Level of PRO reporting, based on the recently published recommendations by the International Society for Quality of Life Research (ISOQOL) (Brundage M, et al, Qual Life Res, 22: 1161-1175, 2013) and the CONSORT PRO recommendations (Calvert M, et al, JAMA, 309: 814-822, 2013);
3. Bias, assessed using the Cochrane Risk of Bias tool which rates RCTs for their adequacy of sequence generation, allocation concealment, blinding of participant/personnel, incomplete outcome data, blinding of outcome assessment, selective outcome reporting and other possible source of bias (Higgins JP, et al, BMJ 2011; 343: d5928).
Lastly, a summary of clinical and PRO data is also extracted from each paper reviewed.
Cancer Disease sites included in the Registry
To date (January 2021) 928 studies have been included in the Registry.
See more details hereunder:
| Cancer Disease sites | Published Until | Nr. of RCTs |
|---|---|---|
| Breast | February 2019 | 187 |
| Lung (Non-Small Cell Lung) | February 2019 | 131 |
| Prostate | February 2019 | 120 |
| Colorectal/anal | February 2019 | 107 |
| Gynecological | February 2019 | 86 |
| Bladder | February 2019 | 18 |
| Leukemia/Lymphoma/MDS* | January 2019 | 81 |
| Multiple Myeloma | January 2021 | 26 |
| Head & Neck | June 2015 | 66 |
| Esophago-gastric | February 2013 | 29 |
| Pancreas | March 2013 | 24 |
| Brain | June 2013 | 14 |
| Kidney | June 2013 | 13 |
| Melanoma | September 2013 | 10 |
| Liver primary | March 2013 | 9 |
| Sarcoma | August 2013 | 5 |
| Testicular | May 2012 | 3 |
| *Myelodysplastic syndromes |