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The role of patient-reported outcomes (PROs) in healthcare: drug development, medical practice and clinical trials

2022-04-13

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The development of a new drug is directly dependent on a successful clinical trial which, in turn, requires the submission of a series of clinical results, namely:

  • Clinician-reported outcomes (CROs), as observed by a physician or requiring a physician’s interpretation. One example of this would be the results of an x-ray.¹
  • Laboratory-reported outcomes (LROs), as measured by an instrument.¹
  • Patient-reported outcomes (PROs), reporting the patient’s health status directly from the patient himself/herself, with no interpretation of the clinical response by a physician or anyone else. ²’³

Although CROs and LROs are essential materials of tremendous clinical value, they may be insufficient in certain conditions. According to experts, CROs and LROs are inadequate in clinical conditions involving, for example, states of pain, depression or fatigue, since they are lacking several key components with regard to the patient’s experience and quality of life.¹

Herein lies the importance of PROs, which are used specifically for drugs to treat chronic, debilitating and incurable diseases to improve the patient’s symptoms and quality of life.¹

 

The importance of a PRO in healthcare

PROs may be required, for example, while developing a drug for cancer, depression, insomnia, asthma, rheumatoid arthritis or irritable bowel syndrome. In the cases of cancer and rheumatoid arthritis, PROs are used to assess the impact of the drug on patients’ quality of life. ¹

The FDA (Food and Drug Administration) and EMA (European Medicines Agency) recommend the use of PROs to assess the efficacy of clinical trial results by analysing the patient’s symptoms, satisfaction and adherence to treatment.¹’²

Although initially devised to support research, PROs are becoming more frequently used in clinical practice, providing key information for decision-making on patient health and prescribed therapies by physicians. Furthermore, PROs are also used to evaluate healthcare performance, and are thus useful in improving health systems.²

 

How to prepare a PRO

PROs contain key information for supporting healthcare decisions and patient care, including:

  • Symptoms experienced by the patient;
  • Relationship between the patient’s health and quality of life;
  • Patient satisfaction with regard to healthcare;
  • Adherence to medicines and prescribed therapies;
  • Perceived value of the treatment.²

To prepare this report, responses must be obtained directly from the patient. These responses may be collected and measured using various methods: by filling out questionnaires (with no clinical interpretation by a physician), conducting interviews or using healthcare scales.¹

 

Translation of PROs: the “why” and “how”

The preparation of PROs for international use requires translation as well as cultural adaptation into other languages. The process is very specific and complex, similar to that of translating healthcare scales (see more details in this article). Normally it involves the following steps:

  1. Translation of the original document by at least two separate translators, preferably professionally certified native speakers;
  2. Comparison and reconciliation of the two translated versions, resulting in a single translated version;
  3. Back-translation of the last document version into the original language by two separate translators with the same qualifications and characteristics as in point 1;
  4. Performance of a test of cognitive interviews using a panel of patients residing in the target country;
  5. Review of the test result by a panel of experts;
  6. Creation of the final version of the translated PRO. 4

 

If you need help with any of these steps, you can count on L10N, a company with 20 years of experience offering certified medical translation and pharmaceutical translation services in 40 languages. These are done by professional translators who specialize in the area of healthcare and are native speakers of the required mother tongue.

References:

1 Bansal, D. et al. Role of patient-reported outcomes and other efficacy endpoints in the drug approval process in Europe (2008-2012). Journal of Epidemiology and Global Health, 2015.

2 NIH Collaboratory Coordinating Center – Rethinking Clinical Trials, Patient -Reported Outcomes, 2014.

3 Patient-reported outcomes, EUPATI, disponível em https://toolbox.eupati.eu/glossary/resultados-reportados-pelos-doentes/?lang=pt-pt, accessed in December 2021.

4 Acquadro C., et al. Translating patient-reported outcome measures: a multi-step process is essential. J Bras Pneumol, 2014.

 


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