PROMOTION Registry | Promotion Database Content
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PROMOTION METHODOLOGY

Characteristics of Clinical Trials included in the DB

  1. Randomized Controlled Clinical trials
  2. Enrolling at least 50 patients overall
  3. Having included a Patient-Reported Outcome (PRO) component
  4. Published since January 2004

Evidence Acquisition

Published papers meeting the above reported criteria are mainly searched through the following electronic databases: PubMed/Medline, the Cochrane library, PsycINFO and PsycARTICLES.

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 DB

To date several hundreds of studies published since January 2004 have been included in the DB. See more details hereunder:

Cancer Disease sites Published Until Nr. of RCTs
Colorectal/anal April 2017 97
Prostate April 2017 101
Testicular May 2012 3
Bladder May 2014 9
Head & Neck June 2015 66
Gynecological July 2017 84
Breast April 2017 170
Brain June 2013 14
Esophago-gastric February 2013 29
Sarcoma August 2013 5
Kidney June 2013 13
Liver primary March 2013 9
Lung (Non-Small Cell Lung) April 2017 120
Melanoma September 2013 10
Pancreas March 2013 24
Leukemia December 2013 18
Myelodysplastic syndromes December 2013 7