2020
A Systematic Review of Patient‐Reported Outcomes in Primary Biliary Cholangitis and Primary Sclerosing Cholangitis
Kim HP, Lieber SR, Rogers ME, Moon AM, Loiselle M, Walker J, Assis DN, Safer R, Gomel R, Evon DM. A Systematic Review of Patient‐Reported Outcomes in Primary Biliary Cholangitis and Primary Sclerosing Cholangitis. Hepatology Communications 2020, 4: 1502-1515. PMID: 33024919, PMCID: PMC7527768, DOI: 10.1002/hep4.1567.Peer-Reviewed Original ResearchPrimary biliary cholangitisPrimary sclerosing cholangitisHealth-related qualityPRO instrumentsPRO conceptsSclerosing cholangitisAdverse eventsBiliary cholangitisSystematic reviewDecreased health-related qualityPhysical adverse eventsGastrointestinal adverse eventsNumeric rating scaleTarget populationStudy populationVisual analogueCholangitisPatient experiencePsychometric testingPatient validationStudy outcomesRating ScaleDescriptive statisticsOutcome conceptsOutcomes
2017
Assessment of established patient reported outcomes (PROs) instruments measuring toxicities and quality of life (QOL) for patients (pts) with head and neck cancer (HNC) treated on ECOG 1308 and 2399 studies.
Cmelak A, Flamand Y, Li S, Marur S, Murphy B, Cella D, Forastiere A, Burtness B. Assessment of established patient reported outcomes (PROs) instruments measuring toxicities and quality of life (QOL) for patients (pts) with head and neck cancer (HNC) treated on ECOG 1308 and 2399 studies. Journal Of Clinical Oncology 2017, 35: 6074-6074. DOI: 10.1200/jco.2017.35.15_suppl.6074.Peer-Reviewed Original ResearchFACT-HNQuality of lifeLate toxicityConformal RTLow doseHigh cure ratesRT doseTreatment toxicityCure rateStandard doseVanderbilt HeadNeck cancerKatz IndexPatient outcomesInstrumental activitiesOutcome instrumentsDaily livingDose reductionPRO dataIMRT dosePRO instrumentsRT techniquesFatigue indexDosePatients
2013
The Psoriasis Symptom Diary: development and content validity of a novel patient‐reported outcome instrument
Lebwohl M, Swensen A, Nyirady J, Kim E, Gwaltney C, Strober B. The Psoriasis Symptom Diary: development and content validity of a novel patient‐reported outcome instrument. International Journal Of Dermatology 2013, 53: 714-722. PMID: 23557000, DOI: 10.1111/j.1365-4632.2012.05798.x.Peer-Reviewed Original ResearchMeSH KeywordsAdaptation, PhysiologicalAdaptation, PsychologicalAdolescentAdultAge FactorsAgedCohort StudiesFemaleHumansMaleMiddle AgedObserver VariationPsoriasisPsychometricsQuality of LifeSelf ReportSeverity of Illness IndexSex FactorsSickness Impact ProfileSurveys and QuestionnairesTreatment OutcomeYoung AdultConceptsSymptom diaryPatient experienceNovel patient-reported outcome instrumentContent validityPatient-reported outcome instrumentsPsoriasis-related symptomsQuantitative psychometric testingChronic plaque psoriasisImpact of symptomsQualitative patient interviewsVariety of symptomsPatient's daily lifeNew PRO instrumentAppearance of plaquesPlaque psoriasisEfficacy endpointPsoriasis treatmentPatient interviewsClinical trialsNew patientsPatient understandingOutcome instrumentsImportant symptomKey patient experiencesPRO instruments
2011
Validity of two new patient‐reported outcome measures in systemic sclerosis: Patient‐reported outcomes measurement information system 29‐item health profile and functional assessment of chronic illness therapy–dyspnea short form
Hinchcliff M, Beaumont JL, Thavarajah K, Varga J, Chung A, Podlusky S, Carns M, Chang RW, Cella D. Validity of two new patient‐reported outcome measures in systemic sclerosis: Patient‐reported outcomes measurement information system 29‐item health profile and functional assessment of chronic illness therapy–dyspnea short form. Arthritis Care & Research 2011, 63: 1620-1628. PMID: 22034123, PMCID: PMC3205420, DOI: 10.1002/acr.20591.Peer-Reviewed Original ResearchMeSH KeywordsAdultAge of OnsetAgedChronic DiseaseCross-Sectional StudiesDyspneaFemaleHealth StatusHealth Status IndicatorsHumansMaleMichiganMiddle AgedPredictive Value of TestsPrognosisRegistriesReproducibility of ResultsScleroderma, SystemicSelf ReportSeverity of Illness IndexTime FactorsYoung AdultConceptsOutcomes Measurement Information SystemComposite severity scoreMeasurement Information SystemSeverity scorePRO instrumentsPROMIS-29SSc patientsHealth profileFunctional assessmentHealth statusPatient-reported outcome measuresPatient-reported outcome instrumentsRaynaud's phenomenon symptomsSSc disease durationSystemic sclerosis trialMean patient ageNew patient-reported outcome measurePatient-Reported Outcomes Measurement Information SystemPhysical functioning scoresCross-sectional studyDisease severity scoreShort formNew PRO instrumentComplicated scoring systemsDisease durationUse of Patient-Reported Outcomes in Randomized, Double-Blind, Placebo-Controlled Clinical Trials
Dinan MA, Compton KL, Dhillon JK, Hammill BG, DeWitt EM, Weinfurt KP, Schulman KA. Use of Patient-Reported Outcomes in Randomized, Double-Blind, Placebo-Controlled Clinical Trials. Medical Care 2011, 49: 415-419. PMID: 21368680, PMCID: PMC3682647, DOI: 10.1097/mlr.0b013e3182064aa2.Peer-Reviewed Original ResearchConceptsPatient-reported outcomesClinical trialsPRO instrumentsDisease-specific patient-reported outcomesDisease-specific PRO instrumentsMore PROsUse of PROsPrimary trial outcomeCurrent clinical trialsStudy inclusion criteriaUse of patientMultivariable analysisLarge trialsMajor therapeutic areasInclusion criteriaPRO measurementRelevant outcomesTrial outcomesLogistic regressionClinical researchStudy outcomesPRO outcomesTrialsTherapeutic areasStatistical significance
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