title: Patient-reported outcomes (PRO) focused on adverse events (PRO-AEs) in adjuvant and metastatic breast cancer: clinical and translational implications.
abstract: The capture of adequate treatment outcomes and quality of life (QOL) of advanced breast cancer patients in clinical routine represents a great challenge. Patient-reported outcomes (PROs) are data elements directly reported by patients about experiences with care, including symptoms, functional status, or quality of life. There is growing interest in the medical community for the evaluation and implementation of PROs of adverse events (PRO-AEs). Recent interest in PROs in health care has evolved in the context of patient centeredness. Our primary objective was to identify trials that had implemented PRO-AEs in the breast cancer treatment setting, thereby demonstrating its feasibility. We aimed to identify published studies that used patient reports to assess AEs during and after breast cancer treatment, to identify clinician underreported and modifiable AEs that are important to patients, and to analyze the feasibility and usefulness of PRO instrument implementation in everyday oncological practice with special attention given to electronic-based PRO instruments.
  
  
  
  We conducted a systematic search of PubMed for studies that used PRO instruments to assess AEs of breast cancer treatment in the metastatic and adjuvant settings. Two authors independently reviewed the search results and decided which studies fully met the predefined inclusion criteria.
  
  
  
  The search yielded 606 publications. The two reviewers found that 9 studies met the inclusion criteria. Three AEs were identified as important to patients but inadequately reported by health care providers, namely hot flushes, vaginal dryness, and weight gain.
  
  
  
  PROs and PRO-AEs are the consequence of contemporary concepts of patient-centered medicine and the growing feasibility, utility, and implications of collecting data using modern technology. Furthermore, the willingness of patients to utilize innovative applications for their own health has been increasing in parallel to the enhanced impact of the World Wide Web. Especially, the coverage of the metastatic situation promises numerous findings on the structure and quality of health care, enabling implementation of individually tailored interventions. Remote electronic self-reporting (i.e., home reporting) is feasible and is associated with high compliance levels.
authors.affiliation: Department of Gynecology and Obstetrics, Heidelberg University Hospital, Im Neuenheimer Feld 440, 69120, Heidelberg, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Stefanovic
authors.affiliation: Department of Gynecology and Obstetrics, Heidelberg University Hospital, Im Neuenheimer Feld 440, 69120, Heidelberg, Germany. markus.wallwiener@med.uni-heidelberg.de.
authors.forename: Markus
authors.initials: M
authors.lastname: Wallwiener
authors.affiliation: IMDI Science Center, International Medical Diplomacy Institute, Vodovodska 27a, Belgrade, 11000, Serbia.
authors.forename: Uros
authors.initials: U
authors.lastname: Karic
authors.affiliation: Department of Gynecology and Obstetrics, Heidelberg University Hospital, Im Neuenheimer Feld 440, 69120, Heidelberg, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Domschke
authors.affiliation: IMDI Science Center, International Medical Diplomacy Institute, Vodovodska 27a, Belgrade, 11000, Serbia.
authors.forename: Luka
authors.initials: L
authors.lastname: Katic
authors.affiliation: Department of Women's Health, University Hospital Tuebingen, Calwerstr. 7, 72076, Tübingen, Germany.
authors.forename: Florin-Andrei
authors.initials: FA
authors.lastname: Taran
authors.affiliation: IMDI Science Center, International Medical Diplomacy Institute, Vodovodska 27a, Belgrade, 11000, Serbia.
authors.forename: Aleksandra
authors.initials: A
authors.lastname: Pesic
authors.affiliation: Department of Women's Health, University Hospital Tuebingen, Calwerstr. 7, 72076, Tübingen, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Hartkopf
authors.affiliation: Department of Bone Oncology, Gynecological Endocrinology and Reproductive Medicine, Philipps-University of Marburg-Krankenhaus Nordwest, Steinbacher Hohl 2-26, 60488, Frankfurt am Main, Germany.
authors.forename: Peyman
authors.initials: P
authors.lastname: Hadji
authors.affiliation: Department of Psychosomatic Medicine and Psychotherapy/Psycho-Oncology, Tuebingen University Hospital, Osianderstr. 5, 72076, Tuebingen, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Teufel
authors.affiliation: Department of Gynecology and Obstetrics, Heidelberg University Hospital, Im Neuenheimer Feld 440, 69120, Heidelberg, Germany.
authors.forename: Florian
authors.initials: F
authors.lastname: Schuetz
authors.affiliation: Department of Gynecology and Obstetrics, Heidelberg University Hospital, Im Neuenheimer Feld 440, 69120, Heidelberg, Germany.
authors.forename: Christof
authors.initials: C
authors.lastname: Sohn
authors.affiliation: Department of Gynecology and Obstetrics, Erlangen University Hospital, Universitätsstraße 21-23, 91054, Erlangen, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Fasching
authors.affiliation: Department of Gynecology and Obstetrics, Heidelberg University Hospital, Im Neuenheimer Feld 440, 69120, Heidelberg, Germany.|National Center for Tumor Diseases (NCT) Heidelberg, Im Neuenheimer Feld 460, 69120, Heidelberg, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Schneeweiss
authors.affiliation: Department of Women's Health, Research Institute for Women's Health, Tuebingen University Hospital, Calwerstr. 7, 72076, Tuebingen, Germany.
authors.forename: Sara
authors.initials: S
authors.lastname: Brucker
mesh_terms: D001943:Breast Neoplasms / Q000150:complications*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology*; D005260:Female; D006801:Humans; D009362:Neoplasm Metastasis; D000071066:Patient Reported Outcome Measures; D011788:Quality of Life / Q000523:psychology*; D057566:Self Report; D016896:Treatment Outcome
keywords: Adjuvant; Adverse events; Breast cancer; Metastatic; Patient-reported outcome