title: Integration of clinical and patient-reported outcomes in surgical oncology.
abstract: BACKGROUND
  Patient-reported outcomes (PROs) provide information about the patient perspective and experience of undergoing surgery for cancer, but evidence suggests that they are not used widely to influence practice. This review considers key challenges and opportunities for using PROs effectively in gastrointestinal surgical oncology, drawing on principles learnt from surgical oncology in general.
  
  
  METHODS
  Systematic reviews of randomized controlled trials (RCTs) in surgical oncology reporting PROs as primary or secondary outcomes, and studies examining methods to communicate PRO information, were identified. Common themes are summarized and the future of PRO studies considered.
  
  
  RESULTS
  Reviews highlighted the need for improved design, conduct and reporting of PROs in RCTs in surgical oncology. Main issues related to the multiplicity of PRO measures hindering data synthesis and clinical understanding, problems with missing data risking bias, and limited integration of clinical and PRO data undermining the role of PRO data in practice. Reviews indicated that patients want PRO data to meet information needs and early work shows that graphically displayed PROs are understood by patients.
  
  
  CONCLUSIONS
  PROs have a role in the evaluation of surgical oncology, but increased consensus and collaboration between surgeons and methodologists is needed to improve the design, conduct and reporting of PROs with clinical outcomes in trials. Possible solutions include investing more effort and systematic thought into the PRO rationale in RCTs, the development and use of 'core outcome sets' with PROs, and implementation of the extension to the Consolidated Standards of Reporting Trials (CONSORT) guidelines for reporting PROs in RCTs.
authors.affiliation: Academic Unit of Surgical Research, School of Social and Community Medicine, University of Bristol, UK.
authors.forename: R C
authors.initials: RC
authors.lastname: Macefield
authors.forename: K N L
authors.initials: KN
authors.lastname: Avery
authors.forename: J M
authors.initials: JM
authors.lastname: Blazeby
mesh_terms: D019033:Delivery of Health Care, Integrated / Q000458:organization & administration*; D005770:Gastrointestinal Neoplasms / Q000628:therapy*; D006801:Humans; D008495:Medical Oncology / Q000458:organization & administration*; D017063:Outcome Assessment, Health Care / Q000379:methods* / Q000458:organization & administration*; D017410:Practice Guidelines as Topic; D016032:Randomized Controlled Trials as Topic; D057566:Self Report; D016896:Treatment Outcome