title: 'Trial Exegesis': Methods for Synthesizing Clinical and Patient Reported Outcome (PRO) Data in Trials to Inform Clinical Practice. A Systematic Review.
abstract: OBJECTIVE
  The CONSORT extension for patient reported outcomes (PROs) aims to improve reporting, but guidance on the optimal integration with clinical data is lacking. This study examines in detail the reporting of PROs and clinical data from randomized controlled trials (RCTs) in gastro-intestinal cancer to inform design and reporting of combined PRO and clinical data from trials to improve the 'take home' message for clinicians to use in practice.
  
  
  METHODS
  The case study was undertaken in gastro-intestinal cancer trials. Well-conducted RCTs reporting PROs with validated instruments were identified and categorized into those combining PRO and clinical data in a single paper, or those separating data into linked primary and supplemental papers. Qualitative methods were developed to examine reporting of the critical interpretation of the trial results (trial exegesis) in the papers in relation of the PRO and clinical outcomes and applied to each publication category. Results were used to inform recommendations for practice.
  
  
  RESULTS
  From 1917 screened abstracts, 49 high quality RCTs were identified reported in 36 combined and 15 linked primary and supplemental papers. In-depth analysis of manuscript text identified three categories for understanding trial exegesis: where authors reported a "detailed", "general", or absent PRO rationale and integrated interpretation of clinical and PRO results. A total of 11 (30%) and 6 (16%) combined papers reported "detailed" PRO rationale and integrated interpretation of results although only 2 (14%) and 1 (7%) primary papers achieved the same standard respectively. Supplemental papers provide better information with 11 (73%) and 3 (20%) achieving "detailed" rationale and integrated interpretation of results. Supplemental papers, however, were published a median of 20 months after the primary RCT data in lower impact factor journals (median 16.8 versus 5.2).
  
  
  CONCLUSIONS
  It is recommended that single papers, with detailed PRO rationale and integrated PRO and clinical data are published to optimize trial exegesis. Further work to examine whether this improves the use of PRO data to inform practice is needed.
authors: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, Bristol, United Kingdom.|Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom.
authors: Angus G K
authors: http://orcid.org/0000-0002-2601-9258
authors: AG
authors: McNair
authors: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, Bristol, United Kingdom.
authors: Rhiannon C
authors: RC
authors: Macefield
authors: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, Bristol, United Kingdom.|Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom.
authors: Natalie S
authors: NS
authors: Blencowe
authors: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, Bristol, United Kingdom.
authors: Sara T
authors: ST
authors: Brookes
authors: Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Canynge Hall, Bristol, United Kingdom.|Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom.
authors: Jane M
authors: JM
authors: Blazeby
mesh_terms: D006801:Humans; D063868:Patient Outcome Assessment; D000071066:Patient Reported Outcome Measures; D016032:Randomized Controlled Trials as Topic