lecture 2, Guideline for selecting OMS.pdf

Guideline for selecting Outcome Measures Instruments Mohammed TA, Omar, PhD. PT,PGDCR CAMS-KSU,  The objective of this lecture is to Objective provide Therapists a guide in selecting an OMs Current problems with the OMs in clinical trials...

Guideline for selecting Outcome Measures Instruments Mohammed TA, Omar, PhD. PT,PGDCR CAMS-KSU,  The objective of this lecture is to Objective provide Therapists a guide in selecting an OMs Current problems with the OMs in clinical trials Failure to Lack of High degree of Variation in collect information on Biased variability outcome outcomes that the reporting of across trials in measurement are most measurement outcomes in the outcomes instruments meaningful to properties of published trials reported used patients the instruments J Comp Eff Res. 2016 Mar; 5(2): 193–205.  Current problems with the outcomes in clinical trials Failure to collect outcomes that are most meaningful to patients Relief of symptoms. Return to work. Cost-efficient patient management Patient satisfaction Statistical/clinical significance (MCID)  Current problems with the outcomes in clinical trials High degree of variability across trials in the outcomes reported At present, many studies that explore the effects of the same intervention on a specific health condition measure or report different outcomes. This makes it difficult to compare, contrast or combine the findings of these studies when making decisions and setting policies, causing problems for people trying to use the output from healthcare research.  Current problems with the outcomes in clinical trials Variation in outcome measurement instruments used, Outcome measurement instruments Number of items Response Scoring Availability or Questions option Physical function 24-item Roland Morris Disability 24 0–1 0–24 Yes , no fees Questionnaire (RMDQ-24) Oswestry Disability Index version 2.1a (ODI 10 0–6 0–100 Yes, fees may apply 2.1a) Quebec Back Pain Disability Scale (QBPDS) 20 0–5 0–80 Yes, fees may apply Outcome measurement Number of items or Response option Scoring Availability instruments Questions EuroQol-5D-3L (EQ-5D-3L) 5 items 1 VAS 1-3 (items) 0-100 0-1 (items) 0-100 (VAS) Yes, fees may appl (VAS) Health- Short Form Health Survey 12 (SF-12) 12 Varying number from 0-100 (physical and mental Yes, fees may apply related quality of 2 to 6 component summary life scores)  Current problems with the outcomes in clinical trials Lack of information on the measurement properties of OMs lack of clarity in the literature about terminology and definitions of measurement properties, lack of evidence on the measurement properties of many outcome measurement instruments, Inconsistency in methods used to determine these measurement properties.  Current problems with the outcomes in clinical trials Lack Biased reporting of outcomes in published trials. 40–62% of studies had at least one primary outcome that was changed, introduced or omitted in the period between the production of these documents describing what the researchers planned to do and what they eventually did. 55% (157/283) of reviews in the first cohort could not include data for the review on the primary outcome from all eligible studies , and 86% (79/92) of the second cohort could not include full data from the main harm outcome of interest for all studies. Framework to guide the selection of outcome measures COSMIN Initiative COMET Initiative To raise awareness of current problems with outcomes in To Improve the selection of OMIs. clinical trials To developed methodological standards for To encourage Core Outcomes (COS) development & measurement properties of OMIs uptake To standardize the selection of outcomes & OMIs is To promote patient and public input into COS development needed. To provide resources to facilitate this To facilitate the development and application of To avoid unnecessary duplication of effort agreed standardized COS To encourage evidence-based COS development Guideline for Selecting Instruments for a Core Outcome COMET Initiative | Downloadable slide set (comet- Set COSMIN initiative.org) Guideline for selecting outcome measurement Conceptual Finding existing Considerations OMS instruments Four steps in the selection of OMIs for COS Generic Quality recommendations assessment of on selection of OMs instruments OMs instruments Prinsen CAC et al. Trials 2016;17:449  Conceptual Considerations Construct (i.e., outcome or domain) to be measured Target population Age ( Adults versus geriatric), Gender Disease characteristics ( acute versus chronic) Administration mode, country/language version, Specific area of health or healthcare inpatient or outpatient setting Types of OMs Generic /Disease Specific/ Performance based/self-reported  Conceptual Considerations Predictive Discriminative Evaluative OMs OMs OMs Used to forecast future Differentiate between patient Detecting the magnitude of status and identify risk, groups and on the basis of a longitudinal change in an Select treatment programs particular characteristic. individual or group Set treatment goals, Facilitate a proper discharge plan, Short Physical Performance Battery Short Physical Performance Battery, 6MWT , TUG, BBS Performance-Oriented Mobility 6MWT Assessment  Conceptual Considerations For example: Construct: pain : What exactly do you want to measure? Pain intensity, pain interference, pain behavior? Average pain last week, current pain, achievement of an acceptable pain state? Pain interference Pain Brief Pain Inventory (BPI-PI) Numeric Rating Scale (NRS) Multidimensional Pain Inventory (MPI-PI) Conceptual Considerations For example: Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire Timed-up and go test (TUG), Functional Reach Test (FRT), Step test Demonstrated good discriminative ability of functional measures in patients of knee OA classified based on radiographic severity Muscles, Ligaments and Tendons Journal 2021;11 (1)  Finding existing OMS instruments It is recommended that COS developers aim for finding all existing instruments Three sources of information: a. Systematic review (Up to date and good quality) b. Literature search (PubMed, OVID, EMBASE, Cochrane library CINAHL) ) c. Use other sources (optional)  Contact the developer of the OMs  Reference lists of the included studies  Contact the colleagues and experts in your area of practice  The Database is a centralized location Data in which information concerning bases for outcomes measures is collected and OMs made accessible to users Description of the outcome measure, Number of questions (items) contained in the measure, Target population, Time required to administer the measure, How the measure is administered, List of languages into which the measure has been translated, Links and contacts to access or obtain the outcome measure, and Cost (if any) to obtain the outcome measure. Link OMs into ICF Review related to psychometric properties  Name of data base URL COSMIN database of systematic reviews of https://database.cosmin.nl/ outcome measurement instruments: Rehabilitation measures database https://www.sralab.org/rehabilitation- measures Some Resources Arabic Health Measures https://ahm.pnu.edu.sa/ for Identifying Patient-Reported Outcome and Quality of Life http://www.proqolid.org/ Instruments Database Potential StrokEngine Assess (specific to outcome measures specific to stroke) http://www.medicine.mcgill.ca/strokengine- assess/ Outcome APTA Neurology Section EDGE ANPT Outcome Measures Measures recommendations Outcome Measures - SCIRE Professional Recommendations (EDGE) (neuropt.org) Outcome Measures - SCIRE Professional (scireproject.com) Core Outcome Measures in Effectiveness Trials COMET Initiative | Home (comet- initiative.org)  Quality assessment of OMs instruments methodological COSMIN quality checklist quality assessment of measurement the OMIs properties quality of the OMIs feasibility Checklists for Assessing Study Qualities COSMIN aspects  Internal consistency The degree of interrelatedness among the items Quality Reliability The degree to which the assessment of measurement is free from measurement error OMs Measurement error The systematic instruments and random error of a patient’s score that is not attributed to true changes in the construct to be measured Responsiveness The ability of a measurement instrument to detect change over time in the construct to be measured  Content validity(including face validity) The degree to which the content of a measurement instrument is an adequate reflection of the construct to be measured Structural validity The degree to which the scores of a measurement instrument are an adequate reflection of the dimensionality of the construct to Quality be measured assessment of Hypotheses testing The degree to which the scores of a measurement instrument are OMs consistent with hypotheses based on the assumption that the measurement instrument validly measures the construct to be measured instruments Cross cultural validity The degree to which the performance of the items on a translated or culturally adapted measurement instrument are an adequate reflection of the performance of the items of the original version of the measurement instrument Criterion validity The degree to which the scores of a measurement instrument are an adequate reflection of a ‘gold standard’  Quality assessment of Oms: Feasibility aspects Length of the outcome Interpretability Type of outcome measurement measurement instrument. and Ease of administration instrument completion time Length of the outcome measurement Cost of an OMs instruments instrument Patient’s comprehensibility, Completion time Required equipment mental and physical ability level Ease of standardization Copyright Clinician’s comprehensibility Patient’s physical ability level Cover sensitive personal issue Type of administration Regulatory agency’s requirement and culturally adapted for approval Availability in different settings Ease of score calculation Training required Financial & Patients Therapists resources Generic recommendations on selection of OMs instruments select only one OMI for each outcome in a COS If the outcome of interest is a complex outcome we Select only one outcome measurement recommend that these different aspects be considered instrument for each outcome in a COS as different outcomes Consider whether different (sub)populations Minimum requirements for including an outcome measurement instrument in a high quality evidence for all measurement properties COS Consensus procedure (e.g., a consensus meeting) to get final agreement on the selected OMIs included in a A consensus procedure to agree on the COS among all relevant stakeholders, including patients. outcome measurement instrument for each Group discussions and a plenary discussion plus voting outcome in a COS during a face-to-face meeting among a group of stakeholders can be used to achieve consensus on the final core set of OMIs. Flowchart for the selection of outcome measurement instruments for core outcome sets  References A Core Set of Outcome Measures for Adults With Neurologic Conditions Undergoing Rehabilitation JNPT Volume 42, July 2018 Outcomes reported on the management of COPD exacerbations: a systematic survey of randomised controlled trials ERJ Open Res 2019; 5: 00072-2019 Guideline for selecting outcome measurement instruments for outcomes included in a Core Outcome Set Final version (dated 05-Sep-2016) Making geriatric assessment work: selecting useful measures. Phys Ther. 2001;81:1233–1252.]