title: Overcoming barriers to the implementation of patient-reported outcomes in cancer clinical trials: the PROMOTION Registry.
abstract: Every cancer treatment, irrespective of its clinical effectiveness, has an impact on patients' quality of life (QoL). Even recently developed targeted therapies might have side effects and significantly impact patients' QoL. Thus, understanding the advantages and disadvantages of different treatments from the patient's standpoint has become a must in clinical research and is highly valued by major stakeholders. Thousands of cancer patients are enrolled into randomized controlled trials (RCTs) each year and many complete patient-reported outcome (PRO) instruments to obtain patient-centered information as part of the assessment of the overall effectiveness of the new therapy. Some of these RCTs have generated high quality PRO evidence forming the basis for approval (or support to approval) of drugs by the US Food and Drug Administration. However, a consistent strategy to determine the quality of patient centered evidence presented in RCTs has until recently been lacking. One of the fundamental questions when including PROs in clinical research revolves around methodological robustness and consistency of outcome reporting. Cancer patients, physicians and healthcare system stakeholders need to rely on solid information to make the best possible choice regarding treatment. Therefore generating high-quality findings from PRO assessment in cancer trials is of paramount importance. In an effort to improve quality of PRO assessment and reporting in the near future, the Patient-Reported Outcome Measurements Over Time In ONcology (PROMOTION) Registry was developed. The scope of this Registry is to identify, track, analyse, and store information on all cancer RCTs that have included PROs, and assess the quality of their PRO assessments.
authors.affiliation: Data Center and Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Via Benevento, 6, 00161 Rome, Italy. f.efficace@gimema.it.
authors.forename: Fabio
authors.initials: F
authors.lastname: Efficace
authors.forename: Jonathan
authors.initials: J
authors.lastname: Rees
authors.forename: Peter
authors.initials: P
authors.lastname: Fayers
authors.forename: Andrea
authors.initials: A
authors.lastname: Pusic
authors.forename: Martin
authors.initials: M
authors.lastname: Taphoorn
authors.forename: Elfriede
authors.initials: E
authors.lastname: Greimel
authors.forename: Jaap
authors.initials: J
authors.lastname: Reijneveld
authors.forename: Katie
authors.initials: K
authors.lastname: Whale
authors.forename: Jane
authors.initials: J
authors.lastname: Blazeby
mesh_terms: D006801:Humans; D009369:Neoplasms / Q000523:psychology* / Q000628:therapy; D063868:Patient Outcome Assessment; D016730:Program Development; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000706:statistics & numerical data*; D012042:Registries; D016896:Treatment Outcome