Overcoming barriers to the implementation of patient-reported outcomes in cancer clinical trials

The PROMOTION Registry

Fabio Efficace* (Corresponding Author), Jonathan Rees, Peter Fayers, Andrea Pusic, Martin Taphoorn, Elfriede Greimel, Jaap Reijneveld, Katie Whale, Jane Blazeby

*Corresponding author for this work

Research output: Contribution to journalComment/debate

15 Citations (Scopus)
4 Downloads (Pure)

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.

Original languageEnglish
Article number86
Number of pages5
JournalHealth and Quality of Life Outcomes
Volume12
Issue number1
DOIs
Publication statusPublished - 6 Jun 2014

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Registries
Clinical Trials
Patient Outcome Assessment
Randomized Controlled Trials
Neoplasms
Quality of Life
Therapeutics
Drug Approval
United States Food and Drug Administration
Patient Reported Outcome Measures
Research
Delivery of Health Care
Physicians

Keywords

  • Cancer
  • Clinical decision-making
  • Clinical trials
  • Patient-reported outcomes
  • Quality of life

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health

Cite this

Overcoming barriers to the implementation of patient-reported outcomes in cancer clinical trials : The PROMOTION Registry. / Efficace, Fabio (Corresponding Author); Rees, Jonathan; Fayers, Peter; Pusic, Andrea; Taphoorn, Martin; Greimel, Elfriede; Reijneveld, Jaap; Whale, Katie; Blazeby, Jane.

In: Health and Quality of Life Outcomes, Vol. 12, No. 1, 86, 06.06.2014.

Research output: Contribution to journalComment/debate

Efficace, Fabio ; Rees, Jonathan ; Fayers, Peter ; Pusic, Andrea ; Taphoorn, Martin ; Greimel, Elfriede ; Reijneveld, Jaap ; Whale, Katie ; Blazeby, Jane. / Overcoming barriers to the implementation of patient-reported outcomes in cancer clinical trials : The PROMOTION Registry. In: Health and Quality of Life Outcomes. 2014 ; Vol. 12, No. 1.
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