11.03.2020

White Paper: PROMs in Oncology

What do we know about patient-reported outcomes in oncology?

Reviewing over 500 publications led to the composition of our latest white paper. Herein, we highlight the most significant results and developments of patient-reported outcomes (PROMs) in oncological research and clinical practice.
White Paper: PROMs in Oncology 1

We at heartbeat medical have been following the development and working with Patient-Reported Outcome Measures (PROMs) for years. During this time, we have gained extensive experience in how to utilise PROMs to measure the health status of patients through collaborations with our customers and research partners. 

In recent years, the goal of disease treatment has shifted. It has moved away from treating organs and diseases through symptoms and biological parameters, but towards treating a human being as a whole. Considering that 1 in 2 people will be diagnosed with cancer during their lifetime and that patients are surviving longer thanks to therapeutic advances, PROMs have the potential to play an influential role in cancer patient care and management. And so, oncology is at the heart of an exciting development of PROMs, evolving from a niche topic to an informative tool for the optimal treatment of cancer patients. 

PROs bring gold-standard research tools in the day to day clinical practice

PROs are data with which the state of the patient’s health can be assessed from their own vantage point. These parameters, which are exclusively reported by patients, include qualities such as “pain”, “quality of life” or “functional status”. Such data are usually collected in the form of standardised questionnaires, so-called Patient-Reported Outcome Measures (PROMs), which have been validated in numerous studies1,2.

Overall, PROs have an enormous potential in research and clinical application promoted by convincing evidence for their more widespread implementation and use3. The literature demonstrates that PROs provide stronger information compared to physician-reported outcomes alone4. PROMs are applicable to many different disease categories and problem areas, as well as being cost-effective and with the right tools, easy to integrate into everyday clinical practice. 

Researchers from the University of Leeds (UK), acknowledged that there was a lack of robust population-based information from which the prevalence and impact of disease and treatment-associated morbidity burden can be ascertained. Thus policy for appropriate interventions and healthcare improvement stagnates. Glaser et al., pointed toward evidence that physical, psychological and social needs are not being addressed by health and social care services treating cancer patients. They were resolute in their opinion that PROMs utilisation should be scaled up and integrated within routine oncological health outcome assessment on a national basis so that the results can be distilled down to the hospital/service provider level with a view to improve patient quality of life5.

Standardisation is key

PROMs enable better patient satisfaction, symptom assessment, risk stratification, therapy monitoring, and long-term measurement of the success of hospital treatment. The additional information gained through PROMs is viewed as being clinically relevant. PROM assessment can influence therapy decisions and symptom management, ultimately improving outcomes6. Moreover, in the realm of pharmacological development,  PROMs are frequently used as secondary endpoints in the oncological approval studies7 – 8.

As PROMs are a relatively new instrument, there is still a lack of sufficient standardisation in many disease and therapeutic areas. Depending on the organisation, different questionnaires, evaluation methods or focal points are recommended making universal comparisons difficult to contend with9. For this reason, initiatives such as the International Consortium for Health Outcomes Measurement (ICHOM) are striving for uniform guidelines10, 11.

Patient-centred medicine from research studies to clinical practice

Overall, there is promising evidence mounting for the benefits of PROMs in both oncological research and routine clinical practice. With the appropriate “know-how” and a reliable, easy-to-use digital infrastructure, PROMs add an important parameter to the conventional patient evaluation by promoting the patient voice in their own treatment journey. PROMs are an objective and relevant measure of patients’ health status from their own perspective and are a step further towards a more patient-centred way of practising medicine.


Download "PROMs in Oncology"
White Paper: PROMs in Oncology 2
written by
Katie O’Keeffe

Medicine and healthcare writer, responsible for international healthcare research at heartbeat.

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Sources:

  1. Weldring T, Smith SM. Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs). Health Serv Insights 2013;6:61-8.
  2. Prinsen CAC, Mokkink LB, Bouter LM, et al. COSMIN guideline for systematic reviews of patient-reported outcome measures. Qual Life Res 2018;27:1147-57.
  3. Cannella L, Efficace F, Giesinger J. How should we assess patient-reported outcomes in the onco-hematology clinic?. Curr Opin Support Palliat Care. 2018;12(4):522–529. 
  4. Warsame R, D’Souza A. Patient Reported Outcomes Have Arrived: A Practical Overview for Clinicians in Using Patient Reported Outcomes in Oncology. InMayo Clinic Proceedings 2019 Sep 25. Elsevier.
  5. Glaser AW, Fraser LK, Corner J, Feltbower R, Morris EJ, Hartwell G, Richards M. Patient-reported outcomes of cancer survivors in England 1–5 years after diagnosis: a cross-sectional survey. BMJ open. 2013 Jan 1;3(4):e002317.
  6. Warrington L, Absolom K, Velikova G. Integrated care pathways for cancer survivors – a role for patient-reported outcome measures and health informatics. Acta Oncol. 2015;54(5):600–608. 
  7. Denis F, Basch E, Septans AL, et al. Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer. JAMA. 2019;321(3):306–307.
  8. Gnanasakthy A, Barrett A, Evans E, D’Alessio D, Romano CD. A Review of Patient-Reported Outcomes Labeling for Oncology Drugs Approved by the FDA and the EMA (2012-2016). Value Health. 2019;22(2):203–209.
  9. Vodicka E, Kim K, Devine EB, Gnanasakthy A, Scoggins JF, Patrick DL. Inclusion of patient-reported outcome measures in registered clinical trials: Evidence from ClinicalTrials.gov (2007-2013). Contemp Clin Trials. 2015;43:1–9.
  10. Zagadailov E, Fine M, Shields A. Patient-reported outcomes are changing the landscape in oncology care: challenges and opportunities for payers. Am Health Drug Benefits. 2013;6(5):264–274. 
  11. Ong WL, Schouwenburg MG, van Bommel ACM, et al. A Standard Set of Value-Based Patient-Centered Outcomes for Breast Cancer: The International Consortium for Health Outcomes Measurement (ICHOM) Initiative. JAMA Oncol. 2017;3(5):677–685.