The evaluation and use of patient reported outcome (PRO) measures requires detailed understanding of the meaning of the outcome of interest. The Food and Drug Administration (FDA) recently presented its draft guidance and view on the use of PRO measures as endpoints in clinical trials. One section of the guidance document specifically deals with advice about the use of the minimal important dif...

Background: The Single Assessment Numeric Evaluation (SANE) is a simple, one-question patient-reported outcomemeasure (PROM). We systematically reviewed correlations between SANE and more extensive PROMs.Methods: We identified studies with correlation coefficients between SANE and other shoulder, knee, and anklespecificPROMs. We calculated mean, median and range across studies...

In medical research, the concept of minimum clinically important difference (MCID) has gained its popularity among clinical practitioners and health policy markers. Over the past 20 years, intensive research has been conducted to explore how clinical significance could be interpreted from the patient reported outcomes (PROs) by using MCID. This article aims to provide a review on the statistica...

1Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine, Dartmouth College, 35 Centerra Parkway, Suite 300, Lebanon, NH 03766, USA; 2Dartmouth-Hitchcock Health, Lebanon, NH, USA ; 3 Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, Sweden ; 4Rare Diseases Sweden, Stockholm, Sweden ; 5Genia, Stockholm, Sweden ; 6Hansen Law, Stockho...

Patient-reported outcome (PRO) measures are being used more frequently in epidemiological studies, health service research and in clinical trials to evaluate therapeutic interventions from the patient's perspective. In MS, where evaluations of treatments are becoming increasingly important, outcome measures that are rigorous and appropriate to patients are needed. This article examines the valu...

OBJECTIVE Cross-cultural translation of patient-reported outcome measures (PROMs) is a lengthy process, often performed professionally. Cognitive interviewing assesses patient comprehension of PROMs. The objective was to evaluate the usefulness of cognitive interviewing to assess translations and compare professional (full) with non-professional (simplified) translation processes. METHODS A f...

- The International Society of Arthroplasty Registries (ISAR) Patient-Reported Outcome Measures (PROMs) Working Group have evaluated and recommended best practices in the selection, administration, and interpretation of PROMs for hip and knee arthroplasty registries. The 2 generic PROMs in common use are the Short Form health surveys (SF-36 or SF-12) and EuroQol 5-dimension (EQ-5D). The Working...

Patient-reported outcome measures (PROMs) have been identified as being measures of a patient's health status or health-related quality of life, allowing for health status information to be collected from patients before and after an intervention through completion of a questionnaire. The information collected will provide an indication of the outcomes or quality of care delivered to NHS Patien...

With the increasing prominence of the patients' involvement in the care they receive, the assessment of outcomes based on the patient's perspective using patient-reported outcome measures (PROMs), are increasingly accompanying the traditional clinical ways of measuring health and the effects of treatment on the patient. This article provides an overview as to what PROMs are and the different he...