cancer patient report outcome design

Patient-reported outcome measures, or PROMs, ask patients how they feel and what activities they can do in daily life. Patients receiving cancer treatment, such as chemotherapy, often have side effects. PROMs can help cancer centers know if patients are getting high-quality care that helps manage their side effects.

Full Answer

Are Patient-Reported Outcome measures useful in cancer care?

In cancer care, using patient-reported outcome measures has particular advantages. Cancer patients experience substantial physical and psychosocial consequences of the disease and its treatment, and much of the symptom burden occurs outside the hospital.

Can patient reporting improve the quality of side-effect data in trials?

"Patient reporting in various forms could improve the quality of side-effect data collection in clinical trials," said Dr. Basch. This is important in drug development, he explained, because if researchers miss or underestimate the severity of side effects caused by a drug they can inadvertently pick the wrong dose or the wrong treatment schedule.

What is this guidance for sponsors of cancer clinical trials?

This guidance provides recommendations to sponsors for collection of a core set of patient-reported clinical outcomes in cancer clinical trials and related considerations for instrument selection and trial design.

Does the FDA endorse pro measures in clinical trials?

FDA does not endorse any specific PRO measure and examples within this document are illustrative and should not be construed as endorsements. This guidance is specific to registration trials for anti-cancer therapies intended to demonstrate an effect on survival, tumor response, or delay in the progression of a malignancy.

How do you develop a patient-reported outcome?

Strategies for Collecting High-Quality Patient-Reported OutcomesSet Clear Goals. ... Use Validated Questions When Possible. ... Avoid Multiple Interpretations of Questions. ... Keep It Short and Sweet. ... Ensure Patient Understanding. ... Choose the Best Method for the Target Population. ... Protect a Patient's Right to Refuse. ... Conclusion.

What is patient-reported outcome data?

A patient-reported outcome (PRO) is "an outcome measure based on a report that comes directly from the patient (e.g., study subject) about the status of the patient's health condition without amendment or interpretation of the patient's response by a clinician or anyone else,” according to the National Health Council. ...

What is patient-reported outcomes research?

Patient-reported outcomes (PROs) are any report of the patients' perspectives about the impact of disease and treatment on their health status, for example quality of life and symptoms, without the interpretation of a clinician, or anyone else [1, 2].

What are patient-reported outcome measure?

Patient-reported outcome measures (PROMs) are used to assess a patient's health status at a particular point in time. PROMs tools can be completed either during an illness or while treating a health condition. In some cases, using pre- and post-event PROMs can help measure the impact of an intervention.

What are two types of patient reported outcome measures?

There are two basic types: General health PROMs can be used to survey patients with any condition. They usually focus on general well-being, mental health and/or quality of life. Condition-specific PROMs usually concentrate on the symptoms of a particular disease.

What are reported outcomes?

Patient-Reported Outcomes (PROs) are defined by the National Quality Forum as “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.” Most healthcare organizations consistently measure things like ...

What is an example of a patient reported outcome?

Health-Related Quality of Life Numerous generic health status measures, such as the Medical Outcomes Study Short Form SF-36 (and related measures) and the Sickness Impact Profile are classic examples.

Why do we use patient reported outcome measures?

The national Patient Reported Outcome Measures (PROMs) programme began in 2009. The purpose of PROMs is to collect information, from patients themselves, about how well the health service is treating them. PROMs allow us to understand the difference that healthcare interventions make to people's quality of life.

What are PROMs and PREMs?

Patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) are used to assess the quality of healthcare experiences, focusing on patients. These measures help healthcare providers, commissioners and other stakeholders to make informed changes to their services.

What are examples of outcome measures?

Outcome Measures For example: The percentage of patients who died as a result of surgery (surgical mortality rates). The rate of surgical complications or hospital-acquired infections.

What is PRO measure in cancer?

Although this guidance focuses on patient-reported outcome (PRO) measures, some of these recommendations may be relevant to other clinical outcome assessments (i.e., clinician-reported outcome, observer-reported outcome, performance outcome) in cancer clinical trials. Recommendations supplement previous guidance on use of PRO measures in clinical trials by providing additional considerations specific to the cancer clinical trial setting. Guidance specific to PRO endpoints and details of analytic methods are not comprehensively covered. FDA does not endorse any specific PRO measure and examples within this document are illustrative and should not be construed as endorsements.

Does the FDA endorse pro measures?

FDA does not en dorse any specific PRO measure and examples within this document are illustrative and should not be construed as endorsements. This guidance is specific to registration trials for anti-cancer therapies intended to demonstrate an effect on survival, tumor response, or delay in the progression of a malignancy.

What are brain and spine cancer patients' questionnaires?

Patients with brain and spine tumors and health care providers that complete survey forms and questionnaires are describing symptoms, mood, general health status, and perceived cognitive symptoms . They also answer questions to help researchers understand the impact and risk factors associated with the disease. This information is used by doctors, along with the evaluation of the tumor tissue and clinical exam, to make recommendations related to treatment and clinical care.

Why do doctors use questionnaires?

Questionnaires are also completed by physicians only to address specifics about the patient’s tumor and treatment history. These questionnaires are paired with the tumor tissue analysis to help researchers study the tumors and design clinical trials.

How long does cancer follow up last?

The care of a cancer patient does not end with the completion of the treatment, it continues with a follow-up phase that typically lasts for years. The follow-up protocol varies depending on the type of disease and treatment, and the protocols are different in different parts of the world, but it typically involves scheduled check-ups and investigations. The goal of follow-up is to detect recurrence of cancer as early as possible and to manage possible long-term side effects of the treatment.

Why is it important to hear the voice of the patient?

The importance of truly hearing the voice of the patient is growing as health systems strive to position patients at the center of care.1 Among the key solutions for more patient-centered clinical