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Before a new medicinal product is introduced to the market, safety, efficacy and tolerability have to be tested. YOU have the experience with your product and we have the experience how to bring YOUR product to YOUR planned market.  

LaNova Consulting one step ahead
LaNova Consulting                             one step ahead

PRO (Patient Reported Outcomes) in RWE

Patient choice over treatment and care is a central feature of many National Health Services bodies and governmental HTAs. Patients' experience of treatment and care is a major indicator of quality and there has been a huge expansion in the development and application of questionnaires, interview schedules and rating scales that measure states of health and illness from the patient’s perspective. Patient-reported outcome measures (PROMs) provide a means of gaining an insight into the way patients perceive their health and the impact that treatments or adjustments to lifestyle have on their quality of life. These instruments can be completed by a patient or individual about themselves, or by others on their behalf.

 

LaNova's understanding of PRO

By using PRO, various types of outcomes can be measured such as physical functions, symptoms, global judgments of health, psychological well-being, social well-being, cognitive functioning, role activities, personal constructs, satisfaction with care, health related quality of life (HRQOL), adherence to medical regimens and clinical trial outcomes.

PROs may be helpful in determination of the eligibility of the patient for certain clinical trials.

PROs can be used for confirmation of the measures.

PROs can help to interpret other measures and also help to eliminate other possibilities.

PROs are useful in determination of patient compliance or reasons for non-compliance.

PROs may be used as study endpoint.

In diseases like cancer it is important to determine the quality of life of the patient as patients with progression of cancer frequently experience multiple symptoms, economical burden, home management problems and lack of emotional well-being, all of which can adversely affect quality of life.

PROs are helpful in the determination of quality of life in cancer patients. Role of QOL/PROs in cancer care can be considered in the following conditions like

  • Determination of negative effects of the adjuvant therapy
  • Identification of the needs for the supportive care
  • Comparison of two standard therapies having similar survival outcomes
  • Identification of negative effects of the therapy when survival time is long
  • To find out whether a new therapy is preferable to standard therapy
  • To determine whether a therapeutic regimen is better than supportive care only, when survival time is short
  • Targeting problems and making the communication easier in clinical practice

As PRO instruments are based upon the scores obtained by the patient without any interpretation; it gives a clear picture about the patient condition.

PROs are useful for the patients, patient-family members and loved ones, healthcare providers, payers, regulatory authorities, technological assessors and researchers.

PROs are beneficial for the patients as he/she asks for and experience the treatment. It is useful for patient family members and loved ones as they desire the best for the patient and themselves.

The PRO data is also useful for healthcare providers and payers as they make a decision with patients on prescribing of treatments/therapy and pay for the treatment respectively. Information obtained from PRO can also be used by regulatory authorities (e.g. FDA) and technology assessors [e.g. National institute for health and clinical excellence (NICE)].

PRO studies make the consequences of the studies accessible through various publications like formulary submission dossiers, direct to consumer advertisements, journals and continuing medical educations (CME).

Conclusively, PROs are unique indicators of impact of disease on the patient, helpful in empowerment of the patients, necessary for determination of efficacy of the treatment, by communication helpful in creating a rapport between patient and healthcare providers, useful in the interpretation of clinical outcomes and treatment decision making.

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