Reliability of patient-reported outcome measures: Hemorrhage, anticoagulant, antiplatelet medication use.
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ABSTRACT: Background
Most antithrombotic medication users are older adults. Patient-reported outcome measures are commonly used in clinical research on antithrombotic medication, such as the diagnosis of intracranial hemorrhage.Objectives
To determine the reliability of patient-reported intracranial hemorrhage, anticoagulant and platelet aggregation inhibitor use in the older adult population.Patients/methods
We conducted a secondary analysis of a prospective, observational cohort study of older adults who presented to the emergency department with a fall. The primary outcome was diagnosis of intracranial bleeding. We compared patient-reported intracranial bleeding to structured chart review with adjudication. We also compared patient-reported use of antiplatelet and anticoagulant medication to physician-reported medication use supplemented with structured chart review. We calculated the diagnostic accuracy of the patient-reported outcomes using our comparators as the reference standard.Results
Exact agreement for patient-reported intracranial bleeds was 95%, with a Cohen's kappa of 0.30 (95% confidence interval [CI], 0.15-0.45). The sensitivity was 36.7% (95% CI, 20.6%-56.1%) and specificity 97.2% (95% CI, 95.8%-98.1%). For anticoagulant medication use, exact agreement was 87%, Cohen's kappa 0.66 (95% CI, 0.63-0.72), sensitivity 84.0% (95% CI, 79.3%-83.8%), and specificity 87.6% (95% CI, 85.1%-89.7%). For antiplatelet medication use, exact agreement was 77%, Cohen's kappa 0.50 (95% CI, 0.44-0.55), sensitivity 68.7% (95% CI, 64.0%-73.1%), and specificity 81.2% (95% CI, 78.0-83.8%).Conclusions
Patient-reported outcome and exposure data were unreliable in this study. Our findings have a bearing on future research study design.
SUBMITTER: Selvanayagam N
PROVIDER: S-EPMC8117814 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveTo categorise patient-reported outcome measures (PROMs) into their propensity to detect intentional and/or unintentional non-adherence to medication, and synthesise their psychometric properties.DesignSystematic review and regression analysis.EligibilityMedication adherence levels studied at primary, secondary and tertiary care settings. Self-reported measures with scoring methods were included. Studies without proxy measures were excluded.Data sourcesUsing detailed searches with key concepts including questionnaires, reliability and validity, and restricted to English, MEDLINE, EMBASE, CINAHL, International Pharmaceutical Abstracts, and Cochrane Library were searched until 01 March 2022. Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 (PRISMA-2020) checklist was used.Data analysisRisk of bias was assessed via COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN-2018) guidelines. Narrative synthesis aided by graphical figures and statistical analyses.Outcome measuresProcess domains [behaviour (e.g., self-efficacy), barrier (e.g., impaired dexterity) or belief (e.g., perception)], and overall outcome domains of either intentional (I), unintentional (UI), or mixed non-adherence.ResultsPaper summarises evidence from 59 studies of PROMs, validated among patients aged 18-88 years in America, the United Kingdom, Europe, Middle East, and Australasia. PROMs detected outcome domains: intentional non-adherence, n=44 (I=491 criterion items), mixed intentionality, n=13 (I=79/UI=50), and unintentional, n=2 (UI=5). Process domains detected include belief (383 criterion items), barrier (192) and behaviour (165). Criterion validity assessment used proxy measures (biomarkers, e-monitors), and scoring was ordinal, dichotomised, or used Visual Analogue Scale. Heterogeneity was revealed across psychometric properties (consistency, construct, reliability, discrimination ability). Intentionality correlated positively with negative beliefs (r(57)=0.88) and barriers (r(57)=0.59). For every belief or barrier criterion-item, PROMs' aptitude to detect intentional non-adherence increased by β=0.79 and β=0.34 units, respectively (R2=0.94). Primary care versus specialised care predicted intentional non-adherence (OR 1.9; CI 1.01 to 2.66).ConclusionsTen PROMs had adequate psychometric properties. Of the ten, eight PROMs were able to detect total, and two PROMs were able to detect partial intentionality to medication default. Fortification of patients' knowledge and illness perception, as opposed to daily reminders alone, is most imperative at primary care levels.
| S-EPMC9486224 | biostudies-literature
Project description:ImportanceOutpatient postpartum recovery is an underexplored area of obstetrics. There is currently no consensus regarding which patient-reported outcome measure (PROM) clinicians and researchers should use to evaluate postpartum recovery.ObjectiveTo evaluate PROMs of outpatient postpartum recovery using Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines.Evidence reviewAn initial literature search performed in July 2019 identified postpartum recovery PROMs and validation studies. A secondary search in July 2020 identified additional validation studies. Both searches were performed using 4 databases (Web of Science, Embase, PubMed, and CINAHL), with no date limiters. Studies with PROMs evaluating more than 3 proposed outpatient postpartum recovery domains were considered. Studies were included if they assessed any psychometric measurement property of the included PROMs in the outpatient postpartum setting. The PROMs were assessed for the following 8 psychometric measurement properties, as defined by COSMIN: content validity, structural validity, internal consistency, cross-cultural validity and measurement invariance, reliability, measurement error, hypothesis testing, and responsiveness. Psychometric measurement properties were evaluated in each included study using the COSMIN criteria by assessing (1) the quality of the methods (very good, adequate, doubtful, inadequate, or not assessed); (2) overall rating of results (sufficient, insufficient, inconsistent, or indeterminate); (3) level of evidence assessed using the Grading of Recommendations, Assessment, Development and Evaluations assessment tool; and (4) level of recommendation, which included class A (recommended for use; showed adequate content validity with at least low-quality evidence for sufficient internal consistency), class B (not class A or class C), or class C (not recommended).FindingsIn total, 15 PROMs (7 obstetric specific and 8 non-obstetric specific) were identified, evaluating outpatient postpartum recovery in 46 studies involving 19 165 women. The majority of psychometric measurement properties of the included PROMs were graded as having very-low-level or low-level evidence. The best-performing PROMs that received class A recommendations were the Maternal Concerns Questionnaire, the Postpartum Quality of Life tool, and the World Health Organization Quality of Life-BREF. The remainder of the evaluated PROMs had insufficient evidence to make recommendations regarding their use (and received class B recommendations).Conclusions and relevanceThis review found that the best-performing PROMs currently available to evaluate outpatient postpartum recovery were the Maternal Concerns Questionnaire, the Postpartum Quality of Life tool, and the World Health Organization Quality of Life-BREF; however, these tools all had significant limitations. This study highlights the need to focus future efforts on robustly developing and validating a new PROM that may comprehensively evaluate outpatient postpartum recovery.
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