Patient-reported outcomes (PRO) focused on adverse events (PRO-AEs) in adjuvant and metastatic breast cancer: clinical and translational implications

被引:18
作者
Stefanovic, Stefan [1 ]
Wallwiener, Markus [1 ]
Karic, Uros [2 ]
Domschke, Christoph [1 ]
Katic, Luka [2 ]
Taran, Florin-Andrei [3 ]
Pesic, Aleksandra [2 ]
Hartkopf, Andreas [3 ]
Hadji, Peyman [4 ]
Teufel, Martin [5 ]
Schuetz, Florian [1 ]
Sohn, Christof [1 ]
Fasching, Peter [6 ]
Schneeweiss, Andreas [1 ,7 ]
Brucker, Sara [8 ]
机构
[1] Univ Heidelberg Hosp, Dept Gynecol & Obstet, Neuenheimer Feld 440, D-69120 Heidelberg, Germany
[2] Int Med Diplomacy Inst, IMDI Sci Ctr, Vodovodska 27a, Belgrade 11000, Serbia
[3] Univ Hosp Tuebingen, Dept Womens Hlth, Calwerstr 7, D-72076 Tubingen, Germany
[4] Philipps Univ Marburg, Krankenhaus Nordwest, Dept Bone Oncol Gynecol Endocrinol & Reprod Med, Steinbacher Hohl 2-26, D-60488 Frankfurt, Germany
[5] Tuebingen Univ Hosp, Dept Psychosomat Med & Psychotherapy Psychooncol, Osianderstr 5, D-72076 Tubingen, Germany
[6] Erlangen Univ Hosp, Dept Gynecol & Obstet, Univ Str 21-23, D-91054 Erlangen, Germany
[7] Natl Ctr Tumor Dis NCT Heidelberg, Neuenheimer Feld 460, D-69120 Heidelberg, Germany
[8] Tuebingen Univ Hosp, Dept Womens Hlth, Res Inst Womens Hlth, Calwerstr 7, D-72076 Tubingen, Germany
关键词
Patient-reported outcome; Adverse events; Breast cancer; Adjuvant; Metastatic; BODY-MASS INDEX; QUALITY-OF-LIFE; COMMON TERMINOLOGY CRITERIA; ENDOCRINE THERAPY; CARDIOVASCULAR-DISEASE; VAGINAL DRYNESS; HOT FLUSHES; WOMEN; SYMPTOMS; CHEMOTHERAPY;
D O I
10.1007/s00520-016-3437-2
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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.
引用
收藏
页码:549 / 558
页数:10
相关论文
共 58 条
[11]   The Missing Voice of Patients in Drug-Safety Reporting [J].
Basch, Ethan .
NEW ENGLAND JOURNAL OF MEDICINE, 2010, 362 (10) :865-869
[12]   Adverse Symptom Event Reporting by Patients vs Clinicians: Relationships With Clinical Outcomes [J].
Basch, Ethan ;
Jia, Xiaoyu ;
Heller, Glenn ;
Barz, Allison ;
Sit, Laura ;
Fruscione, Michael ;
Appawu, Mark ;
Iasonos, Alexia ;
Atkinson, Thomas ;
Goldfarb, Shari ;
Culkin, Ann ;
Kris, Mark G. ;
Schrag, Deborah .
JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE, 2009, 101 (23) :1624-1632
[13]   Native American Breast Cancer Survivors' Physical Conditions and Quality of Life [J].
Burhansstipanov, Linda ;
Krebs, Linda U. ;
Seals, Brenda F. ;
Bradley, Alice A. ;
Kaur, Judith S. ;
Iron, Pamela ;
Dignan, Mark B. ;
Thiel, Carol ;
Gamito, Eduard .
CANCER, 2010, 116 (06) :1560-1571
[14]   Prevalence and Severity of Urogenital Symptoms in Postmenopausal Women Receiving Endocrine Therapy for Breast Cancer [J].
Chin, Sheray N. ;
Trinkaus, Mateya ;
Simmons, Christine ;
Flynn, Candi ;
Dranitsaris, George ;
Bolivar, Robyn ;
Clemons, Mark .
CLINICAL BREAST CANCER, 2009, 9 (02) :108-117
[15]   EVALUATING OUTCOME CRITERIA USED IN METHADONE-MAINTENANCE PROGRAMS [J].
COHEN, M ;
HOWARD, A ;
KLEIN, DF ;
NEWFIELD, K .
INTERNATIONAL JOURNAL OF THE ADDICTIONS, 1976, 11 (02) :283-294
[16]   Management of vaginal dryness and dyspareunia in estrogen sensitive cancer patients [J].
Del Pup, Lino .
GYNECOLOGICAL ENDOCRINOLOGY, 2012, 28 (09) :740-745
[17]  
Dennison CR, 2002, AM J MANAG CARE, V8, pS580
[18]   Validity and Reliability of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) [J].
Dueck, Amylou C. ;
Mendoza, Tito R. ;
Mitchell, Sandra A. ;
Reeve, Bryce B. ;
Castro, Kathleen M. ;
Rogak, Lauren J. ;
Atkinson, Thomas M. ;
Bennett, Antonia V. ;
Denicoff, Andrea M. ;
O'Mara, Ann M. ;
Li, Yuelin ;
Clauser, Steven B. ;
Bryant, Donna M. ;
Bearden, James D., III ;
Gillis, Theresa A. ;
Harness, Jay K. ;
Siegel, Robert D. ;
Paul, Diane B. ;
Cleeland, Charles S. ;
Schrag, Deborah ;
Sloan, Jeff A. ;
Abernethy, Amy P. ;
Bruner, Deborah W. ;
Minasian, Lori M. ;
Basch, Ethan .
JAMA ONCOLOGY, 2015, 1 (08) :1051-1059
[19]  
Egberts TCG, 1996, BRIT MED J, V313, P530
[20]  
European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP), 2014, REFL PAP REG GUID US