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Table 4 Source of evidence provided to support each outcome reporting recommendation (n = 1758) identified within 244 eligible documents

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)

  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
  2. aEmpirical evidence within the source document and citation provided to other document categorizations were not mutually exclusive, nor are the subcategories within each
  3. 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
  4. cThe complete list of citations provided to other documents can be found in the online dataset