Spinal Cord Injury–Functional Index/Capacity: Responsiveness to Change Over Time

ObjectiveTo establish responsiveness of 3 Spinal Cord Injury–Functional Index/Capacity (SCI-FI/C) item banks in the first year after spinal cord injury (SCI).DesignLongitudinal patient-reported outcomes assessment replicated through secondary analysis of an independent data set.SettingA total of 8 SCI Model Systems rehabilitation hospitals in the United States.ParticipantsStudy 1 participants included 184 adults with recent (≤4 months) traumatic SCI and 221 community-dwelling adults (>1 year post injury) (N=405). Study 2 participants were 418 individuals with recent SCI (≤4 months) (N=418).InterventionsIn study 1, SCI-FI/C computer adaptive tests were presented in a standardized interview format either in person or by phone call at baseline and 6-month follow-up. Responsiveness was examined by comparing 6-month changes in SCI-FI scores within and across samples (recently injured vs community-dwelling) because only the recent injury sample was expected to exhibit change over time. Effect sizes were also computed. In study 2, the study 1 results were cross-validated in a second sample with recent SCI 1 year after baseline measurement. Study 2 also compared the SCI-FI/C measures’ responsiveness to that of the Self-reported Functional Measure (SRFM) and stratified results by injury diagnosis and completeness.Main Outcome MeasuresThe SCI-FI Basic Mobility/C, Self-care/C and Fine Motor/C item banks (study 1 and study 2); Self-reported Functional Measure SRFM (study 2 only).ResultsIn study 1, changes in SCI-FI/C scores between baseline and 6-month follow-up were statistically significant (P<.01) for recently injured individuals. SCI-FI Basic Mobility/C, Self-care/C, and Fine Motor/C item banks demonstrated small to medium effect sizes in the recently injured sample. In the community-dwelling sample, all SCI-FI/C effects were negligible (ie, effect size<0.08). Study 2 results were similar to study 1. As expected, SCI-FI Basic Mobility/C and Self-care/C were responsive to change for all individuals in study 2, whereas the SCI-FI Fine Motor/C was responsive only for individuals with tetraplegia and incomplete paraplegia. The SRFM demonstrated a medium effect size for responsiveness (effect size=0.65).ConclusionsThe SCI-FI Basic Mobility/C and Self-care/C banks demonstrate adequate sensitivity to change at 6 months and 1 year for all individuals with SCI, while the SCI-FI/C Fine Motor item bank is sensitive to change in individuals with tetraplegia or incomplete paraplegia. All SCI-FI/C banks demonstrate stability in a sample not expected to change. Results provide support for the use of these measures for research or clinical use.     

Trends of self-reported non-adherence among type 2 diabetes medication users in the United States across three years using the self-reported Medication Adherence Reasons Scale

Background & aimsTo determine the trends of self-reported non-adherence rates among adults taking Type 2 medicines (T2D) medicines between 2017 and 2019 and to identify the patterns for the frequently reported reasons for non-adherence in the United States.Methods & resultsData from the National Health and Wellness Survey, a self-administered, internet-based cross-sectional survey of US adults from 2017 to 2019 was used. Non-adherence was measured using the self-reported Medication Adherence Reasons Scale (MAR-Scale). Frequencies were used to identify the reasons for non-adherence for insulin and non-insulin therapies for T2D.Data were obtained from 2983 respondents in 2017, 5416 in 2018, and 5268 in 2019. Based on the MAR-Scale, the self-reported medication non-adherence rate was 25% in 2017, 21% in 2018, and 27% in 2019. The most common reason for non-adherence across all the three years was simple forgetfulness, yet patients reported the lowest mean number of days missing medication for that reason. Though less frequently reported, non-adherence lasted longer when patient did not know how to take their medicines, cost was a reason, or had concerns about the long term effects of the medicines.ConclusionsWith no significant improvement in adherence with T2D medicines over time, regardless of better awareness and extensive diabetes education, focus should be on individualized non-adherence reasons-based interventions.     

Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States

ObjectivesThe aim of this study was to report 1-year clinical outcomes following commercial transcatheter left atrial appendage occlusion (LAAO) in the United States.BackgroundThe National Cardiovascular Data Registry LAAO Registry was initiated to meet a condition of Medicare coverage and allow the assessment of clinical outcomes. The 1-year rates of thromboembolic events after transcatheter LAAO in such a large cohort of “real-world” patients have not been previously reported.MethodsPatients entered into the National Cardiovascular Data Registry LAAO Registry for a Watchman procedure between January 1, 2016, and December 31, 2018, were included. The primary endpoint was ischemic stroke. Key secondary endpoints included the rate of ischemic stroke or systemic embolism, mortality, and major bleeding. Major bleeding was defined as any bleeding requiring hospitalization, and/or causing a decrease in hemoglobin level > 2g/dL, and/or requiring blood transfusion that was not hemorrhagic stroke. The Kaplan-Meier method was used for 1-year estimates of cumulative event rates.ResultsThe study population consisted of 36,681 patients. The mean age was 76.0 ± 8.1 years, the mean CHA₂DS₂-VASc score was 4.8 ± 1.5, and the mean HAS-BLED score was 3.0 ± 1.1. Prior stroke was present in 25.5%, clinically relevant bleeding in 69.5%, and intracranial bleeding in 11.9%. Median follow-up was 374 days (IQR: 212-425 days). The Kaplan-Meier–estimated 1-year rate of ischemic stroke was 1.53% (95% CI: 1.39%-1.69%), the rate of ischemic stroke or systemic embolism was 2.19% (95% CI: 2.01%-2.38%), and the rate of mortality was 8.52% (95% CI: 8.19%-8.87%). The 1-year estimated rate of major bleeding was 6.93% (95% CI: 6.65%-7.21%). Most bleeding events occurred between discharge and 45 days following the procedure.ConclusionsThis study characterizes important outcomes in a national cohort of patients undergoing transcatheter LAAO in the United States. Clinicians and patients can integrate these data in shared decision making when considering this therapy.     

What do we know about written assessment of health professionals’ communication skills? A scoping review

ObjectiveThe aim of this scoping review was to investigate the published literature on written assessment of communication skills in health professionals’ education.MethodsPubmed, Embase, Cinahl and Psychnfo were screened for the period 1/1995–7/2020. Selection was conducted by four pairs of reviewers. Four reviewers extracted and analyzed the data regarding study, instrument, item, and psychometric characteristics.ResultsFrom 20,456 assessed abstracts, 74 articles were included which described 70 different instruments. Two thirds of the studies used written assessment to measure training effects, the others focused on the development/validation of the instrument. Instruments were usually developed by the authors, often with little mention of the test development criteria. The type of knowledge assessed was rarely specified. Most instruments included clinical vignettes. Instrument properties and psychometric characteristics were seldom reported.ConclusionThere are a number of written assessments available in the literature. However, the reporting of the development and psychometric properties of these instruments is often incomplete. Practice implications written assessment of communication skills is widely used in health professions education. Improvement in the reporting of instrument development, items and psychometrics may help communication skills teachers better identify when, how and for whom written assessment of communication should be used.     

基于COSMIN指南对癌症患者支持性照护需求量表的系统评价

背景国内外用于评估癌症患者支持性照护需求的量表较多，但有关此类量表质量的标准化评价研究及不同量表间的横向比较研究较为缺乏，也少有研究者对此类量表的测量特性进行系统的整合与评价。目的评价中文版癌症患者支持性照护需求量表的测量学性能及研究的方法学质量。方法2021年4月检索中国知网、万方数据知识服务平台、维普中文科技期刊全文数据库、中国生物医学文献数据库、PubMed、EmBase、Web of Science、CINAHL Complete数据库，获取有关中文版癌症患者支持性照护需求量表测量学性能评价的研究，检索时限均为建库至2021年3月30日。由两位研究者独立筛选文献、提取资料后，采用健康测量工具遴选标准（COSMIN）系统综述指南，在对量表的测量特性及研究的方法学质量进行评价的基础上，综合评定中文版癌症患者支持性照护需求评估量表各测量特性的证据等级，并形成对于量表的最终推荐意见。采用描述分析法对评价结果进行汇总、分析。结果共纳入15项研究，涉及8个中文版癌症患者支持性照护需求评估量表〔癌症患者支持性照护需求简明问卷中文版（SCNS-SF34）、中文版支持性照护需求筛查工具（SCNS-ST9-C）、癌症患者综合需求评估量表（CNAT）、癌症需求简明问卷（CNQ-SF）、中文版癌症患者未满足需求量表（CaSUN-C）、癌症患者未满足需求简明量表（SF-SUNS）、晚期癌症患者需求评估问卷（ACNQ-41）、晚期癌症患者需求评估表简表（ACNQ-29）〕。就量表的测量特性质量而言，除ACNQ-29的内容效度为"未提及"外，其余7个量表的内容效度均为"不确定"；除CaSUN-C、SF-SUNS的结构效度为"充分"外，其余6个量表的结构效度均为"不确定"；SCNS-SF34、CNQ-SF、CaSUN-C、SF-SUNS的内部一致性为"充分"，ACNQ-41的内部一致性为"不充分"，其余3个量表的内部一致性为"不确定"；CNAT、CNQ-SF、ACNQ-29的假设检验为"未提及"，CaSUN-C、SF-SUNS、ACNQ-41的假设检验为"不确定"，SCNS-SF34、SCNS-ST9-C的假设检验为"充分"；除ACNQ-41的稳定性为"不充分"，SCNS-ST9-C、ACNQ-29的稳定性为"未提及"外，其余5个量表的稳定性均为"充分"；仅SCNS-SF34的跨文化效度为"充分"，其余7个量表的跨文化效度均为"未提及"。8个量表的推荐等级均为B级。结论SCNS-SF34的测量特性得到了最为全面的评价，其具有较好的信效度，且临床应用可行性高，可暂时被推荐使用，但上述结论仍有待更多高质量证据加以支撑。     

Differences in Evidentiary Requirements Between European Medicines Agency and European Health Technology Assessment of Oncology Drugs—Can Alignment Be Enhanced?

ObjectivesNational health technology assessments (HTAs) across Europe show differences in evidentiary requirements from assessments by the European Medicines Agency (EMA), affecting time to patient access for drugs after marketing authorization. This article analyzes the differences between EMA and HTA bodies’ evidentiary requirements for oncology drugs and provides recommendations on potential further alignment to minimize and optimally manage the remaining differences.MethodsInterviews were performed with representatives and drug assessment experts from EMA and HTA bodies to identify evidentiary requirements for several subdomains and collect recommendations for potentially more efficiently addressing differences. A comparative analysis of acceptability of the evidence by EMA and the HTA bodies and for potential further alignment between both authorities was conducted.ResultsAcceptability of available evidence was higher for EMA than HTA bodies. HTA bodies and EMA were aligned on evidentiary requirements in most cases. The subdomains showing notable differences concerned the acceptance of limitation of the target population and extrapolation of target populations, progression-free survival and (other) surrogate endpoints as outcomes, cross-over designs, short trial duration, and clinical relevance of the effect size. Recommendations for reducing or optimally managing differences included joint early dialogues, joint relative effectiveness assessments, and the use of managed entry agreements.ConclusionsDifferences between assessments of EMA and HTA bodies were identified in important areas of evidentiary requirements. Increased alignment between EMA and HTA bodies is suggested and recommendations for realization are discussed.     

Characterizing Standardized Functional Data at Inpatient Rehabilitation Facilities

ObjectiveThe Improving Medicare Post-Acute Care Transformation Act of 2014 mandates using standardized patient functional data across post-acute settings. This study characterized similarities and differences in clinician-observed scores of self-care and transfer items for the standardized section GG functional domain and the functional independent measure (FIM) at inpatient rehabilitation facilities.DesignWe conducted secondary analyses of 2017 Uniform Data System for Medical Rehabilitation national data. Patients were assessed by clinicians on both section GG and FIM at admission and discharge. We identified 7 self-care items and 6 transfer items in section GG conceptually equivalent with FIM. Clinician-assessed scores for each pair of items were examined using score distributions, Bland-Altman plot, correlation (Pearson coefficients), and agreement (kappa and weighted kappa) analyses.Setting and ParticipantsIn all, 408,491 patients were admitted to Uniform Data System for Medical Rehabilitation-affiliated inpatient rehabilitation facilities with one of the following impairments: stroke, brain dysfunction, neurologic condition, orthopedic disorders, and debility.MeasuresSection GG and FIM.ResultsPatients were scored as more functionally independent in section GG compared with FIM, but change score distributions and score orders within impairment groups were similar. Total scores in section GG had strong positive correlations (self-care: r = 0.87 and 0.95; transfer: r = 0.82 and 0.90 at admission and discharge, respectively) with total FIM scores. Weak to moderate ranking agreements with total FIM scores were observed (self-care: kappa = 0.49 and 0.60; transfers: kappa = 0.43 and 0.52 at admission and discharge, respectively). Lower agreements were observed for less able patients at admission and for higher ability patients of their change scores.Conclusions and ImplicationsOverall, response patterns were similar in section GG and FIM across impairments. However, variations exist in score distributions and ranking agreement. Future research should examine the use of GG codes to maintain effective care, outcomes, and unbiased reimbursement across post-acute settings.     

Construct validity of the Eating Assessment Tool (EAT-10)

Abstract

Purpose: We aimed to evaluate the construct validity of the Eating Assessment Tool (EAT-10) by determining its dimensionality, rating scale integrity, item-person match, precision and relationship with the degree of airway invasion and functional oral intake.

Methods: We conducted a retrospective analysis of patients’ EAT-10 scores. We used the Rasch rating scale model. We investigated correlations between the EAT-10 and scores on the Penetration-Aspiration Scale (PAS) and Functional Oral Intake Scale (FOIS).

Results: The median score of the EAT-10 from 127 patients was 16 of 40 (range 0–40). Confirmatory factor analysis supported unidimensionality. The 5-point rating scale categories met published criteria. Two items misfit the Rasch model and two other items displayed differential item functioning. Rasch person reliability was 0.79. Our patient cohort was divided into three person-strata. Correlations between the EAT-10 and the PAS and FOIS were weak to moderate in strength (respectively: r?=?0.26, p?=?0.0036; r?=??0.27, p?=?0.0027).

Conclusions: Our analyses identified deficits in the construct validity of the EAT-10 suggestive of a need to improve the EAT-10 to support its frequent use in clinical practice and research.

• Implications for Rehabilitation

• Swallowing disorders are associated with severe complications, such as pneumonia and malnutrition, and impose both social and psychological burdens on patients.

• The Eating Assessment Tool is a self-report instrument developed to estimate initial dysphagia severity and monitor change in patient-reported dysphagia symptoms as a response to treatment.

• This study shows that the Eating Assessment Tool has deficits in its construct validity and a need to improve the instrument to support its frequent use in clinical practice and research.