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:Patient Reported Outcome Measures (PROM) evoke measurements that allow capturing patients' perspectives on their condition. In endometriosis care, physicians' understanding of the effect of the disease and the treatment on patients is often poor. The use of PROMs in endometriosis clinical practice can facilitate patient-provider communication and the implementation of patient-centered care, improve patients' quality of life, as well as provide a tool for patients' self-management of the disease. Today, PROMs are extensively used in research and clinical trials, however they are barely used in clinical practice. The development of digital tools facilitating capturing PROMs can contribute to their use by physicians in routine endometriosis care. However, all PROMs are not adapted to be used in routine care in the context of endometriosis. The objective of this study was to present a catalogue of available PROMs for routine endometriosis care and evaluate them according to selected criteria. To do so, we explored the different PROMs currently in the literature. Consequently, 48 PROM were identified as tools used to evaluate various dimensions of the impact of endometriosis on patients. The selected PROMs were evaluated for their potential to be used as a standard in clinical practice in endometriosis. The selected catalogue of PROMs is the starting point for the integration of digital tools to capture PROMs and the development of patient-centered dashboards to be used by patients and clinicians in endometriosis care and self-management to improve care processes, patient satisfaction, quality of life, and outcomes.
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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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| S-EPMC7415058 | biostudies-literature
Project description:Background:Obtaining patients' views of their health and outcomes of interventions utilising patient-reported outcome measures (PROMs) is a well-established method, but there is still uncertainty about the impact of PROMs on services and patient care. Studies are now needed of alternative ways of implementing PROMs. This paper describes a case study of the introduction of a new PROM to assess musculoskeletal (MSK) problems, known as the Musculoskeletal Health Questionnaire (MSK-HQ). Methods:Following an invitation from the Arthritis Research UK (ARUK), 11 groups and organisations agreed to become 'partners' in piloting the MSK-HQ. Twenty-nine interviews and a focus group were carried out with key informants from the partners. Interviews were supplemented with some documentary evidence of partners' meetings. Data were coded and analysed with NVivo software V.10. Analysis was carried out via a framework method. Results:Participants reported positive evidence that the MSK-HQ is feasible and practical for use in patient care with content that helped health professionals identify and address patients' main presenting problems. Although mediated and reported through health professionals' judgments, the questionnaire was also seen as very relevant and acceptable to a wide spectrum of patients.There was also broad support for the view that whilst the MSK-HQ is relevant to individual patient care, it could also, when aggregated, reflect the experiences of patients as a group and be used as evidence for third parties concerned with the provision and commissioning of services.The main difficulties revealed by the case study were in the form of logistics and sustainability. It was recognised that electronic systems would be more effective for administration and data processing but they were not feasible to develop and implement within reasonable timelines and available budgets. A sustainable approach to using the PROM required significant long-term commitment of budget, a coherent system, and active support from diverse organisations. Conclusions:The current study supports the view that a bottom-up approach is a promising method to generate PROM-related insights that are relevant to patients and health professionals. The partnership approach to developing and using PROMs may have wider relevance and potential as a model of implementation.
| S-EPMC6031120 | biostudies-literature
Project description:BackgroundPatient-reported outcome measures (PROMs) are measures of the outcome of treatment(s) reported directly by the patient or carer. There is increasing international policy interest in using these to assess the impact of clinical care.AimsTo identify suitably validated PROMs for asthma and examine their potential for use in clinical settings.MethodsWe systematically searched MEDLINE, EMBASE and Web of Science databases from 1990 onwards to identify PROMs for asthma. These were critically appraised, then narratively synthesised. We also identified the generic PROMs commonly used alongside asthma-specific PROMs.ResultsWe identified 68 PROMs for asthma, 13 of which were selected through screening as being adequately developed to warrant full-quality appraisal: 8 for adults, 4 for children and 1 for a child's caregiver. The PROMs found to be sufficiently well validated to offer promise for use in clinical settings were the Asthma Quality of Life Questionnaire (AQLQ) and mini-AQLQ for adults, and Pediatric Asthma Quality of Life Questionnaire for children. Rhinasthma was considered promising in simultaneously assessing the impact of asthma and rhinitis in those with coexistent disease. We identified 28 generic PROMs commonly used in conjunction with asthma-specific instruments.ConclusionsWe identified asthma PROMs that offer the greatest potential for use in clinical settings. Further work is needed to assess whether these are fit-for-purpose for use in clinical practice with individual patients. In particular, there is a need to ensure these are validated for use in clinical settings, acceptable to patients, caregivers and clinicians, and yield meaningful outcomes.
| S-EPMC4373322 | biostudies-literature
Project description:ObjectivesTo identify patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) in clinical quality registries, for people with cutaneous melanoma, to inform a new Australian Melanoma Clinical Outcomes Registry; and describe opportunities and challenges of routine PROM/PREM collection, especially in primary care.DesignSystematic review.Primary and secondary outcome measuresWhich PROMs and PREMs are used in clinical quality registries for people with cutaneous melanoma, how they are collected, frequency of collection, participant recruitment methods and funding models for each registry.Results1134 studies were identified from MEDLINE, PreMEDLINE, Embase, PsychInfo, Cochrane Database of Abstracts of Reviews of Effects databases and TUFTS Cost-Effectiveness Analysis Registry, alongside grey literature, from database inception to 5th February 2020. Following screening, 14 studies were included, identifying four relevant registries: Dutch Melanoma Registry, Adelphi Real-World Disease-Specific Programme (Melanoma), Patient-Reported Outcomes Following Initial treatment and Long-term Evaluation of Survivorship Registry, and Cancer Experience Registry. These used seven PROMs: EuroQol-5 Dimensions, Functional Assessment of Cancer-General (FACT-G) and FACT-Melanoma (FACT-M), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Cancer 30 (EORTC QLQ-C30), Fatigue Assessment Scale Hospital Anxiety and Depression Scale, Patient-Reported Outcome Measures Information System-29 and one PREM; EORTC QLQ-Information Module 26. PROMs/PREMs in registries were reported to improve transparency of care; facilitate clinical auditing for quality assessment; enable cost-effectiveness analyses and create large-scale research platforms. Challenges included resource burden for data entry and potential collection bias toward younger, more affluent respondents. Feedback from patients with melanoma highlighted the relevance of PROMs/PREMs in assessing patient outcomes and patient experiences.ConclusionsClinical registries indicate PROMs/PREMs for melanoma care can be incorporated and address important gaps, however cost and collection bias may limit generalisability.Prospero registration numberCRD42018086737.
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