title: Development of a conceptual framework of health-related quality of life in locally recurrent rectal cancer.
abstract: OBJECTIVE
  The surgical management of locally recurrent rectal cancer (LRRC) has become widely accepted to afford cure and improve quality of life in this subset of patients. Thus far, traditional surgical and oncological markers have been used to highlight the success of surgical intervention. The use of patient-reported outcomes, specifically health-related quality of life (HRQoL), is sparse in these patients. This may be in part due to the lack of well-designed, validated instruments. This study identifies HRQoL issues relevant to patients undergoing surgery for LRRC, with the aim of developing a conceptual framework of HRQoL specific to LRRC to enable measurement of patient-reported outcomes in this cohort of patients.
  
  
  METHODS
  Qualitative focus groups were undertaken at two institutions to identify relevant HRQoL themes. The principles of thematic content analysis were used to analysis data. NViVo10 was used to analyse data.
  
  
  RESULTS
  Twenty-one patients participated in six consecutive focus groups. Two patterns of themes emerged related to HRQoL and healthcare service delivery and utilization. Identified themes related to HRQoL included symptoms, sexual function, psychological impact, role and social functioning and future perspective. Under healthcare service and delivery and utilization the subdomain of disease management, treatment expectations and healthcare professionals were identified.
  
  
  CONCLUSIONS
  This is the first qualitative study undertaken exclusively in patients with LRRC to ascertain relevant HRQoL outcomes. The impact of LRRC on patients is wide-ranging and extends beyond traditional HRQoL outcomes. The study operationalizes the identified outcomes into a conceptual framework, which will provide the basis for the development of a LRRC-specific patient-reported outcome measure.
authors.affiliation: School of Medicine and Health, University of Leeds, Leeds, UK.|The John Goligher Colorectal Unit, St James' University Hospital, Leeds, UK.
authors.forename: D P
authors.initials: DP
authors.lastname: Harji
authors.affiliation: Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.
authors.forename: C
authors.initials: C
authors.lastname: Koh
authors.affiliation: Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.|Discipline of Surgery, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Solomon
authors.affiliation: Leeds Institute of Cancer and Oncology, University of Leeds, Leeds, UK.|St James's Institute of Oncology, St James's University Hospital, Leeds, UK.
authors.forename: G
authors.initials: G
authors.lastname: Velikova
authors.affiliation: The John Goligher Colorectal Unit, St James' University Hospital, Leeds, UK.
authors.forename: P M
authors.initials: PM
authors.lastname: Sagar
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
authors.forename: J
authors.initials: J
authors.lastname: Brown
mesh_terms: D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000523:psychology* / Q000601:surgery; D011788:Quality of Life; D012004:Rectal Neoplasms / Q000523:psychology* / Q000601:surgery; D011795:Surveys and Questionnaires
keywords: Health related quality of life; advanced pelvic oncology; patient reported outcomes