Interpreting patient-reported outcome results: US FDA guidance and emerging methods. - Wikidata - awgldk - TriplyDB

Interpreting patient-reported outcome results: US FDA guidance and emerging methods.

Interpreting patient-reported outcome results: US FDA guidance and emerging methods.

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Pragmatic Implementation of a Stratified Primary Care Model for Low Back Pain Management in Outpatient Physical Therapy Settings: Two-Phase, Sequential Preliminary Study.New targets in psoriatic arthritis Alprostadil cream in the treatment of erectile dysfunction: clinical evidence and experience Comparable performance of the Kansas City Cardiomyopathy Questionnaire in patients with heart failure with preserved and reduced ejection fraction.Responders vs clinical response: a critical analysis of data from linaclotide phase 3 clinical trials in IBS-C Report of the NIH Task Force on research standards for chronic low back pain Development and validation of a modified Korean version of the Pharmacy Services Questionnaire (PSQ-K) for the quality assessment of community pharmacy services.Conceptual and Analytical Considerations toward the Use of Patient-Reported Outcomes in Personalized Medicine Patient-reported outcomes and survival in multiple sclerosis: A 10-year retrospective cohort study using the Multiple Sclerosis Impact Scale-29.Interpreting effect sizes and clinical relevance of pharmacological interventions for fibromyalgia.An evaluation of the FDA responder endpoint for IBS-C clinical trials: analysis of data from linaclotide Phase 3 clinical trials.Development and validation of the PROcedural Sedation Assessment Survey (PROSAS) for assessment of procedural sedation quality Decay of impact after self-management education for people with chronic illnesses: changes in anxiety and depression over one year.Patient-reported Outcomes for Multicentric Castleman's Disease in a Randomized, Placebo-controlled Study of Siltuximab.Development and validation of a symptom-based activity index for adults with eosinophilic esophagitis.Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial.Prediction of pain outcomes in a randomized controlled trial of dose-response of spinal manipulation for the care of chronic low back pain Interpretability of the PedsQL™ Gastrointestinal Symptoms Scales and Gastrointestinal Worry Scales in Pediatric Patients With Functional and Organic Gastrointestinal Diseases.Thyroid-specific questions on work ability showed known-groups validity among Danes with thyroid diseases.Interpreting small treatment differences from quality of life data in cancer trials: an alternative measure of treatment benefit and effect size for the EORTC-QLQ-C30.Minimal important improvement thresholds for the six-minute walk test in a knee arthroplasty cohort: triangulation of anchor- and distribution-based methods.Development and validation of a symptom index for advanced hepatobiliary and pancreatic cancers: the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy (NCCN-FACT) Hepatobiliary-Pancreatic Symptom Index (NFHSI).Maintaining primacy of the patient perspective in the development of patient-centered patient reported outcomes.A qualitative study of perceptions of meaningful change in spinal muscular atrophy Effect of ivacaftor treatment in patients with cystic fibrosis and the G551D-CFTR mutation: patient-reported outcomes in the STRIVE randomized, controlled trial Quality of life and technology: impact on children and families with diabetes Agreement about identifying patients who change over time: cautionary results in cataract and heart failure patients.Patient-Reported Outcomes in Oncology Drug Labeling in the United States: A Framework for Navigating Early Challenges.Minimal clinically important improvement (MCII) and patient-acceptable symptom state (PASS) in total hip arthroplasty (THA) patients 1 year postoperatively.Inflammatory markers and development of symptom burden in patients with multiple myeloma during autologous stem cell transplantation.Don't middle your MIDs: regression to the mean shrinks estimates of minimally important differences.Asthma outcome measures.Interpretation of patient-reported outcomes.Predicting improvement of functioning in disability claimants.Quantitative challenges facing patient-centered outcomes research.Focus article: report of the NIH Task Force on Research Standards for Chronic Low Back Pain.Best (but oft-forgotten) practices: expressing and interpreting associations and effect sizes in clinical outcome assessments.Patient-reported outcomes for US oncology labeling: review and discussion of score interpretation and analysis methods.Patient reported outcomes in GNE myopathy: incorporating a valid assessment of physical function in a rare disease.Current Status of Celiac Disease Drug Development.

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Interpreting patient-reported outcome results: US FDA guidance and emerging methods.

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What is the relationship between the minimally important difference and health state utility values? The case of the SF-6D

Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance

Use of the cumulative proportion of responders analysis graph to present pain data over a range of cut-off points: making clinical trial data more understandable.

A method of comparing the areas under receiver operating characteristic curves derived from the same cases.

Evaluating the statistical significance of health-related quality-of-life change in individual patients.

Approaches and recommendations for estimating minimally important differences for health-related quality of life measures.

Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale.

Evaluating minimal clinically important differences for the acne-specific quality of life questionnaire.

Determining a minimal important change in a disease-specific Quality of Life Questionnaire.

Further evidence supporting an SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life.

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