Table 4.
Source of evidence provided to support each outcome reporting recommendation (n = 1758) identified within 244 eligible documents
| 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) |
CONSORT Consolidated Standards of Reporting Trials, ICH International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, PRO Patient Reported Outcomes, SPIRIT Standard Protocol Items: Recommendations for Interventional Trials
aEmpirical evidence within the source document and citation provided to other document categorizations were not mutually exclusive, nor are the subcategories within each
bIncludes any type of literature review that aimed to assess the completeness of reporting in the included articles from either an original review or a secondary analyses of documents included in a prior review
cThe complete list of citations provided to other documents can be found in the online dataset