From: Outcome reporting recommendations for clinical trial protocols and reports: a scoping review
 | N (%) |
---|---|
Empirical evidence provided within source document and/or citations provided | 1027 (58.4) |
No empirical evidence or citations provided | 731 (41.6) |
Empirical evidence provided within source documenta | 704 (40.0) |
 Literature review | 513 (29.2) |
  Systematic and/or scoping review | 290 (16.5) |
  Assessment of reporting completenessb | 170 (9.7) |
  Other type of review | 68 (3.9) |
 Expert consensus | 373 (21.2) |
 Interview | 12 (0.7) |
 Case study | 2 (0.1) |
 Survey | 1 (0.06) |
Citation(s) provided to other document(s)a | 582 (33.1) |
 Citations to existing reporting guidelines | |
  SPIRIT-PRO | 253 (14.4) |
  CONSORT-PRO | 241 (13.7) |
  CONSORT | 141 (8.0) |
  SPIRIT | 42 (2.4) |
  Other CONSORT extensions | 26 (1.5) |
 Citations to selected key guidance documentsc | |
  ICH E6 Good Clinical Practice Guideline | 71 (4.0) |
  International Society for Quality of Life Research (ISOQOL)-recommended PRO reporting standards | 14 (7.9) |
  ICH E9 Statistical Principles for Clinical Trials | 8 (0.5) |
  International Committee of Medical Journal Editors (ICMJE) | 7 (0.4) |
  ICH E3 Structure and Content of Clinical Study Reports | 5 (0.3) |
  Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) publication | 4 (0.2) |
  ClinicalTrials.gov guidelines | 3 (0.2) |
  Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) publications | 2 (0.1) |