Patient Reported Outcomes definition

Patient Reported Outcomes means the outcomes from medical care that are important to patients and their support groups.
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Patient Reported Outcomes means outcomes from medical care that are important to patients and their support groups.
Sample 1Sample 2
Patient Reported Outcomes means a measurement that focuses on a patient’s health state, symptomology and effectiveness as perceived by such patient, which measurement gauges the effect or results of treatment for a set of patients of comparable clinical characteristics for which there are no objective measures and results can only be obtained from the patient (e.g., quality of life (QoL)), which is a value assigned to duration of life as modified by the impairments, physical, social and psychological functional states, perceptions and opportunities that are influenced by disease, injury, treatment or policy.
Sample 1

Examples of Patient Reported Outcomes in a sentence

  • Talk presented at Patient Reported Outcomes Seminar Series, University of North Carolina.

  • Two-Year Patient Reported Outcomes for Patients Undergoing Revision Hip Arthroscopy with Capsular Defects.

  • Two-Year Patient Reported Outcomes for Patients Undergoing Revision Hip Arthroscopy for Symptomatic Instability Due to Capsular Insufficiency.

  • Minimally important differences were estimated for six Patient- Reported Outcomes Measurement Information System-Cancer scales in advanced-stage cancer patients.

  • Nonpharmacological Treatments of Insomnia for Long-Term Painful Conditions: A Systematic Review and Metaanalysis of Patient- Reported Outcomes in Randomized Controlled Trials.

  • Electronic Patient Reported Outcomes uses the following tiers structure:● Tier 1: 1 to 25,000 ePro Case Report Forms● Tier 2: 25,001 to 50,000 ePro Case Report Forms● Tier 3: 50,000 to 100,000 ePro Case Report Forms● Tier 4: 100,001 to 500,000 ePro Case Report Forms● Tier 5: more than 500,000 ePro Case Report FormsNote: The data captured in the ePRO module counts as Data Points.

  • ENDPOINTS 188 5.1 Primary Endpoints 188 5.2 ABSORB IV Major Secondary Endpoint 188 5.3 Additional Secondary Endpoint(s) 189 5.4 Informational Endpoints 190 5.4.1 Patient Reported Outcomes 190 5.4.2 Health Economics 190 6.

  • Applying the Patient- Reported Outcomes Measurement Information System to Assess Upper Extremity Function among Children with Congenital Hand Differences.

  • Mental Health Diagnosis, Not Patient Reported Outcomes, is Predictive of Failing to Meet the Expected Outcomes Following Successful Implementation of a Enhanced Recovery After Surgery Protocol After Elective Colon Resection.

  • Patient- Reported Outcomes of Capsular Repair Versus Capsulotomy in Patients Undergoing Hip Arthroscopy: Minimum 5-Year Follow-up-A Matched Comparison Study.

Related to Patient Reported Outcomes

  • Adverse Event means any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

  • Routine patient care costs means Covered Medical Expenses which are typically provided absent a clinical trial and not otherwise excluded under the Policy. Routine patient care costs do not include:

  • Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Routine Patient Costs means all health care services that are otherwise covered under the Group Contract for the treatment of cancer or other Life-threatening Condition that is typically covered for a patient who is not enrolled in an Approved Clinical Trial.

  • Disinfection profile means a summary of daily Giardia lamblia inactivation through the treatment plant. The procedure for developing a disinfection profile is contained in s. NR 810.34.

  • patient record means a written account of all services provided to a patient by the home health agency, as well as other pertinent information necessary to provide care.

  • Patient Data means any electronic data, information or material about a Patient entered into the Software.

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • COVID-19 symptoms means fever of 100.4 degrees Fahrenheit or higher, chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea, unless a licensed health care professional determines the person’s symptoms were caused by a known condition other than COVID-19.

  • Substance abuse treatment means outpatient or inpatient services or participation in Alcoholics Anonymous or a similar program.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Coordinated licensure information system means an integrated process for collecting, storing, and sharing information on nurse licensure and enforcement activities related to nurse licensure laws that is administered by a nonprofit organization composed of and controlled by licensing boards.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • HEPA filter means high-efficiency particulate air filters that are rated to achieve a minimum initial particle-removal efficiency of 99.97 per cent using ASTM F 1471– 93 or equivalent standard;

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

  • Project Management Report means each report prepared in accordance with Section 4.02 of this Agreement;

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Covered contractor information system means an information system that is owned or operated by a contractor that processes, stores, or transmits Federal contract information.

  • Medication means any drug, chemical, compound, suspension, or preparation in suitable form for use as a curative or remedial substance taken either internally or externally by any person.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.