Accessibility: Skip to content

According to US-FDA definition, a patient reported outcome (PRO) is any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else [1].

Patient reports are widely used in clinical trials, but there has been a growing interest to integrate these methods into routine clinical practice. Sophisticated, user-friendly electronic systems on a computer or smart phone enables patients´ to report in real-time topics related to their health status such as symptoms, physical functioning and mental health. PRO data obtained from disease-specific validated questionnaires can be transferred automatically to the patient´s electronic medical records and used e.g. to alert clinical staff when reported symptoms require medical attention and provide tailored electronic guidance for the patient [2].

Patient reported outcomes have been applied also to routine cancer care, where patients undergo aggressive and potentially painful treatments and several years long follow-up periods outside the hospital. The routine use of patient reported outcomes measures (PROM) in oncology setting have been shown to provide many benefits to patients as well as to health care professionals.

Benefits that patient reported outcomes provide for patients and health care professionals

To patients:

  • Earlier detection of symptoms [3]
  • Improved symptom control [4]
  • Improved communication between clinician and patient [3,5,6]
  • Improved health related quality of life [5,7]
  • Increased patient satisfaction [5]
  • Less frequent hospitalization and admission to ER [7]
  • Longer continuation of chemotherapy [7,8]
  • Increased overall survival in cancer patients [8,9]

To health care professionals:

  • Provides systematically collected symptom data for a clinician [2]
  • Improves accuracy of the symptom assessment [2]
  • Supports clinical decision making [3]
  • Improves the monitoring of treatment response [6]
  • Improves patient-physician communication [3,5,6]
  • Saves time during clinical visits and helps to focus discussion based on the reported data [2]
  • Positive impact on health outcomes [6]
  • Enables better and more patient-centered clinical care [6]

Clinicians can utilize real-time PROM in many ways, e.g. to collect relevant disease-specific data using well-structured questionnaires, to identify patients requiring acute care and more intense follow-up, as well as to obtain more focused and efficient treatment processes. Patient self-reporting helps to understand how interventions during different phases of the cancer care impact patient´s quality of life and gives insights to improved patient experience and promotion of patient-centered care.

In Finland, currently two companies provide solutions for PRO-based data collection and utilization. Noona (http://www.noona.com) provides a smart cloud-based mobile service designed to capture patient-reported outcomes in Oncology. Kaiku Health (https://kaikuhealth.com/) is a digital platform supporting patient-reported outcomes monitoring in several medical specialties, such as cancer, fertility and preventive care.

References:

1. Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. U.S. Department of Health and Human Services Food and Drug Administration. December 2009.

2. Bennett A, Jensen RE and Basch E. Electronic Patient-Reported Outcome Systems in Oncology Clinical Practice. CA Cancer J Clin, 62:336-347, 2012.

3. Howell D, Molloy S, Wilkinson K, Green E, Orchard K, Wang K and Liberty J. Patient-reported outcomes in routine cancer clinical practice: a scoping review of use, impact on health outcomes, and implementation factors. Ann Oncol, 26(9):1846-1858, 2015.

4. Kotronoulas G, Kearney N, Maguire R, Harrow A, Di Domenico D, Croy S and MacGillivray S. What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials. J Clin Oncol, 32(14):1480-1501, 2014.

5. Velikova G, Booth L, Smith AB, Brown PM, Lynch P, Brown JM and Selby PJ. Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J. Clin Oncol, 22(4):714-724, 2004.

6. Chen J, Ou L and Hollis SJ. A systematic review of the impact of routine collection of patient reported outcome measures on patients, providers and health organisations in an oncologic setting. BMC Health Serv Res, 13:211, 2013

7. Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA and Schrag D. Symptom monitoring with patient-reported outcomes during routine cancer treatment: A randomized controlled trial. J Clin Oncol, 34(6):557-565, 2016.

8. Basch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C and Schrag D. Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. JAMA, 318(2):197-198, 2017.

9. Denis F, Lethrosne C, Pourel N, Molinier O, Pointreau Y, Domont J, Bourgeois H, Senellart H, Trémolières P, Lizée T, Bennouna J, Urban T, El Khouri C, Charron A, Septans AL, Balavoine M, Landry S, Solal-Céligny P and Letellier C. Randomized trial comparing a web-mediated follow-up with routine surveillance in lung cancer patients. J Natl Cancer Inst, 109(9), 2017.

Previous section:
Evaluation of effectiveness

Next section:
Real World Evidence (RWE)