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How to develop and evaluate a PRO instrument? - Pubrica

PRO or Patient-reported outcome is a relatively novel method to evaluate the outcome of any treatment by clinician or researcher (in clinical trial) purely based on the inputs got from the patient alone.<br>Full Information : https://bit.ly/2VPA4uX<br><br>Reference : https://pubrica.com/services/data-analytics-machine-learning/<br><br>Why pubrica?<br><br>When you order our services, we promise you the following u2013 Plagiarism free, always on Time, outstanding customer support, written to Standard, Unlimited Revisions support and High-quality Subject Matter Experts.<br><br>Contact us :t<br>Web: https://pubrica.com/<br>Blog: https://pubrica.com/academy/<br>Email: sales@pubrica.com<br>WhatsApp : 91 9884350006<br>United Kingdom: 44-74248 10299<br><br>Related Topics:<br>Literature gap and future research<br>Meta-Analysis in evidence-based research<br>Biostatistics in clinical research<br>Scientific Communication in healthcare<br><br>Tags:<br>Medical writing service | Scientific communication services | Scientific research services | Clinical trials | Publication services | Scientific Manuscript editing services | healthcare data analytics services<br>

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How to develop and evaluate a PRO instrument? - Pubrica

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  1. HOWTODEVELOPAND EVALUATEAPRO INSTRUMENT AnAcademicpresentation by Dr.NancyAgens,Head,TechnicalOperations,PubricaGroup:www.pubrica.com Email:sales@pubrica.com

  2. Today'sDiscussion Outline WhatisPRO AsktheDoctor,WhyAskthePatient WhatInformationDoIWantfromthePatient?–ThePROInstrumentDesigningaValidPROInstrument EvaluatingPROInstrument Conclusion

  3. WhatisPRO? PROorPatient-reportedoutcomeisarelativelynovelmethodtoevaluatetheoutcomeofanytreatmentbyclinicianorresearcher(inclinicaltrial)purelybasedontheinputsgotfromthepatientalone. TheUnitedStatesFoodandDrugAdministration(US-FDA)definesPROas‘anyreportofthepatient’shealthconditionthatcomesdirectlyfromthepatient,withoutinterpretationofthepatient’sresponsebyaclinicianoranyoneelse.’

  4. AsktheDoctor,WhyAskthePatient? Objectivedataregardingoutcomecanbegivenbythetreatingphysician,byinvestigationsandbythecaregiver. TheseareObserver-reportedoutcomes(OROs)andmedicinehaslongreliedontheseforevidence-basedmanagement. TheconceptofHealth-relatedQualityofLife,amulti-dimensionalapproachthatrecordspatient’sperceivedeffectoftheillnessandtreatmentonqualityoflifeinhis/herphysical,mental,emotional,economical,andsocialspace. PROdataisusedtoinformandguidepatient-centeredcare,toassessriskandbenefitfromtreatment,todecideontreatmentprotocolsandtoguidehealthpolicymakers.

  5. WhatInformationDoIWantfromthe Patient?–ThePROInstrument ThePROinstrumentisthemeanstocollectthedatarelatedtothePROconcept,intheformofquestionnaireandtheinformationanddocumentationthatsupportsitsuse. Inotherwords,PROinstrumentisaquestionnairethatcompilesdatarelatedtothePROconceptofinterestwhichcanbesummarizedasascore. Contentvalidityistheextenttowhichaninstrumentmeasurestheconceptofinterestthatisdesiredfromboththedeveloper’sanduser’sperspective.

  6. DesigningaValid PROInstrument Contd..

  7. Stepsinvolvedare:- 1.DEFININGTHECONCEPT ConceptshouldbeclearlydefinedbasedonreviewandliteraturegapanalysisofexistingPROinstrumentsaswellastakinginputsfromscientificresearchservices,developersandmostimportantlythepatientsortheusers. 2.CONCEPTUALFRAMEWORK Breakdowntheconcepttosub-conceptsandfinallytoitemsorthequestionsthatwillbeincludedinthequestionnaire. 3.END-POINTMODEL Endpointisthefinalmeasuredoutcomeofthetreatmentthatwillbecompared,andanendpointmodelsummarisesalltheendpointbasedonOROsandPROs. Contd..

  8. 4.REVIEWOFPRELIMINARYINSTRUMENT Literacyreviewisdonetounderstandtheproportionofpeoplewhomayor maynothavetheliteracyleveltotakethequestionnaire. Translationreviewisdonetoensureconceptualequivalencewhen translatedtoanotherlanguage. Cognitiveinterviewistheprocesswheretheuserismadetotakethe questionnairebythinkingaloudtounderstandtheapproachoftheuserto thequestions. Contd..

  9. 5.RELIABILITYTESTING Measuretoestimatereproducibilityandconsistenttrueestimationofoutcomesunderconsideration.Itisfurtherdescribedbelow. 6.VALIDATION Itisanongoingnever-endingprocessofimprovingtheinstrumentbyrepeatedfeedbackmechanism.

  10. EvaluatingPROInstrument Asclinicalvalidationdataaccumulates,aPROinstrumentundergoesreviewandrevisiontomakethemrobust.Itincludestheevaluatingforthefollowing:- 1.VALIDITY istheextenttowhichthescoresandtheirinterpretations,supportedbytheoreticalevidence,correlatewiththeproposeduseoftheinstrument. a.ContentValidity-Itisameasureofhowmuchtheinstrumentmeasurestheconceptofinterest. (i)Qualitativeestimation–includeitemsinvolved,theirrecallperiod,response options,scoringpattern,methodofconductingthequestionnaireetc. Contd..

  11. (ii)Quantitativeestimation–e.g. =>Itemresponsetheory(IRT)–Apowerfultooltoassesswhethertheitemsusedmeasuretheentirespectrumorcontinuumofthepatientresponses. =>Raschanalysis-OnlyIRTtooltousethetotalofalltheitemsinthePROinstrumentmakingitasimplemodel. b.ConstructValidity-Itisbasedoncomparisonwithconvergentanddivergentgroupswithknownvalidityandshowingthattheinstrumentunderstudyconformstosimilarinterpretations. c.CriterionValidity-Comparisonwithknowncriteriaorknowngoldstandardfor thisconcept. Contd..

  12. 2.RELIABILITY a.Reproducibilityortest-retestreliability-Itisassessedundersameconditionsinsameuserinaclosespanoftimetoassessanyvariationsinrecordingresultsthatcanbeattributedtotheinstrument. b.Internalconsistency-Theitemsshoulddeliversamescoresinsimilarsituationsconsistently. c.Floorandceilingeffect–i.e.theinstrument’sabilitytomeasureextremesofconstructhelpschoosetheproperinstrumentforthestudy. d.Inter-interviewerreliability-thereshouldnotbesignificantdifferenceinscoreswheninterviewedbytwodifferentinterviewers. e.Variability–Instrumentshouldhaveabilitytodetectchangeswhenoutcomesaredifferent,elseitisnogood.

  13. Conclusion AdheringtogoodpracticeswhiledesigningandvalidatingaPROinstrumentisprimaryforittobeeffectiveandreceiveregulatoryapprovals. Readinesstocontinuouslyrevisitandreviseitemsisneededtodobetterjusticetotheconceptofinterestinthelongrun.

  14. ContactUs UNITEDKINGDOM +44-1143520021 INDIA +91-9884350006 EMAIL sales@pubrica.com

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