Patient Reported Outcomes

The outcomes of clinical activity are traditionally measured in terms of morbidity and mortality.  This data are collected by clinical staff.  Measuring patient reported outcomes (PRO) with standardized questionnaires is an emerging tool for qualitative evaluation of clinical care. A PRO is a report of the status of a patient’s health that comes directly from the patient without being interpreted by the doctor or anybody else.  The PRO instruments can be generic or disease-specific such as rheumatoid arthritis. The concept of self-reporting is key. For most patients there is little opportunity outside the clinical encounter to communicate their symptoms, concerns and fears.  PROs assess what patients are able to do and how they feel about asking questions. The type of outcomes that really matter are the patient’s symptoms, mental status, effects of the disease and its treatment, and how he is coping.  Symptoms are of great importance.  The patient can provide details about the frequency of symptoms, severity of symptoms, the impact of the symptoms on daily life, and the perception of the patient towards his disease and its treatment.  It can lead to faster more personalized care.  Until recently PROs were not in widespread use in clinical practice.  There is a lack of familiarity about aggregating patient level outcomes for measuring performance in healthcare delivery.

The introduction of PROs has begun to produce promising results.  Some hospitals have a core set of PRO assessments.  PROs can improve physician-patient satisfaction, enable important dialogue, improve workflow, and increase physician satisfaction.  PROs help to bridge the gap between the clinical world and the patient world.  They facilitate conversations and augment the patient interaction1. There is learning curve in the establishment of PROs.  Feedback initially tends to concentrate on concerns and challenges.  Time and effort needs to be invested in the characterization of normal patient responses for various conditions.  The use of digitalized PROs is increasing. This poses challenges.  Electronic collection of PROs requires investment in hardware and staff training in its use. The key to success of PROs is that the technology must work.  The caregivers and patients must become comfortable with the system. The usual set-up is an electronic ePRO software that enables the patient to self-report via the internet, an app, or an automated phone system.The type of response scales used include- the Likert scale, the visual analog scale, the pictorial scale, the rating scale, and the checklist.

Over time better quality data begins to flow.  It will take physicians time to understand this new information source.  Patients start measuring, reporting and sharing responsibility for the management of their condition.  Care givers begin to get a better understanding of the patient’s symptoms. This is important because it has been stated that clinicians understanding of the effects of disease and treatment on patients’ lives is poor.  Orthopaedics is very suited to PROs because of the emphasis on pain and function.  Another example is inflammatory bowel disease with the concentration on pain and diarrhoea. Using a spinal surgery example, doctors can get a better understanding of the degree of the patient’s pain postoperatively.  The patient is able to document how long the pain lasts and when mobility free pain is achieved.  The real patient experience can be imparted to other patients.  Also treatments can be modified in the light of the PRO feedback.

Clinicians are fearful that PROs may take up more time, an additional step in an already busy day.  Also some may feel that they spend sufficient time talking to their patients, and that they do not need additional information from them.  These sentiments reflect a lack of understanding of the PRO concept. Patients and their families are very interested in finding out how individuals with the same condition coped with the treatment and fared into the future2.  This information complements the therapeutic details provided by the medical and nursing team.  Rotenstein et al1 give the example of discussions about incontinence and impotence in a patient considering a prostatectomy or surveillance.  The demonstration of real patient data about these complications gives the individual a better insight into what option to choose.

PROs can be used proactively.  The patient can complete the symptom questionnaire prior to visiting the doctor.  The prior answering of check lists enables the consultation to concentrate on the most relevant concerns.  In other situations the PRO can identify previously undetected depression. Wagle3 in an audio interview gave guidance on how an institution can develop PROs.  Leadership buy in is important.  Examples of where it has worked are helpful.  It is critical to choose the right initial target or specialty.  Conditions with a high symptom count are suitable because they provide that the patient with a range of measures to evaluate during the course of his treatment. It is helpful to demonstrate situations where it has worked well.  The correct technology platform is important, electronic forms of PRO are the future.

PROs offer a useful potential in clinical research and trials.  Deshpande et al4 describe how to evaluate treatment efficacy across the 3 parameters; the physical examination (non-PRO), biochemical tests (non-PRO), symptoms of the disease/treatment (PRO). PROs are increasingly being used in oncology because they reflect how  patients feel and function.  There is a drive to integrate the systematic collection of symptoms during routine cancer clinical care.  The patient’s PRO can be communicated with the clinicians, other patients/caregivers, the healthcare system, and health service researchers.  The Cochrane Collaborative has created a PRO methods group website.  Its objective is to advise how to incorporate PROs into systematic reviews.  The concept reflects an understanding that self reported measures from patients help to determine whether treatments are working effectively.

In summary PROs have the potential to strengthen the clinician-patient relationship.

JFA Murphy

1. Rotenstein LS, Huckman RS, Wagle NW. Making patients and doctors happier – the potential of patient – reported outcomes. N Engl J Med 2017;377:1309-1312
2. Nelson E, Eftimovska E, Lind C, Wasson JH, Lindblad S. Patient reported outcome measures in practice. BMJ 2015;350:7818
3. Wagle NW. Audio interview @ NEJM .org
4. Deshpande PR, Rajan S, Sudeepthi BL, Nazar CPA. Patient reported outcomes: A new era in clinical research. Perspect Clin Res 2011;2:137-144