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Objective: Functioning is an important outcome for rheumatoid arthritis (RA) management. Heterogeneity of respective patient-reported outcome measures (PROMs) challenges direct comparisons between their results. This study aimed to standardize reporting of such PROMs measuring functioning in RA to facilitate comparability.
Methods: Common Item Non-Equivalent Groups Design (NEAT) with the Health Assessment Questionnaire (HAQ) as a common scale across data sets from various countries (incl. UK, Turkey and Germany) to establish a common metric. Other PROMs included are the Physical Function items of the Multidimensional Health Assessment Questionnaire (MDHAQ), Disabilities of Arm, Shoulder and Hand (DASH), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), World Health Organization Disability Assessment Schedule Version 2.0 (WHODAS 2.0), and four short forms (20, 10, 6, and 4 physical function items) from the Patient-Reported Outcomes Measurement Information System (PROMIS). As the HAQ includes mobility, self-care and domestic life items, this study focuses on these three domains. PROMs were described using Standard Error of Measurement (SEM) and Smallest Detectable Difference (SDD). Rasch Measurement model was used to create the common metric.
Results: Range of SEM is 0.2 (MDHAQ) to 7.4 (SF36-PF). SDD revealed a range from 9.7 % (WOMAC-RAT) to 33.5 % (WHODAS-PF). PROMs co-calibration revealed fit to the Rasch measurement model. A transformation table was developed to allow exchange between PROMs scores.
Discussion: Scores between the Daily Activity PROMs commonly used in RA can now be compared. Factors such as SEM and SDD help determine choice of PROM in clinical practice and research.
Background
Vertigo, dizziness and balance disorders (VDB) are among the most relevant contributors to the burden of disability among older adults living in the community and associated with immobility, limitations of activities of daily living and decreased participation. The aim of this study was to identify the quality of evidence of physical therapy interventions that address mobility and participation in older patients with VDB and to characterize the used primary and secondary outcomes.
Methods
A systematic search via MEDLINE (PubMed), Cochrane Library, CINAHL, PEDro, forward citation tracing and hand search was conducted initially in 11/2017 and updated in 7/2019. We included individual and cluster-randomized controlled trials and trials with quasi-experimental design, published between 2007 and 2017/2019 and including individuals ≥65 years with VDB. Physical therapy and related interventions were reviewed with no restrictions to outcome measurement. Screening of titles, abstracts and full texts, data extraction and critical appraisal was conducted by two independent researchers. The included studies were heterogeneous in terms of interventions and outcome measures. Therefore, a narrative synthesis was conducted.
Results
A total of 20 randomized and 2 non-randomized controlled trials with 1876 patients met the inclusion criteria. The included studies were heterogeneous in terms of complexity of interventions, outcome measures and methodological quality. Vestibular rehabilitation (VR) was examined in twelve studies, computer-assisted VR (CAVR) in five, Tai Chi as VR (TCVR) in three, canal repositioning manoeuvres (CRM) in one and manual therapy (MT) in one study. Mixed effects were found regarding body structure/function and activities/participation. Quality of life and/or falls were assessed, with no differences between groups. VR is with moderate quality of evidence superior to usual care to improve balance, mobility and symptoms.
Conclusion
To treat older individuals with VDB, VR in any variation and in addition to CRMs seems to be effective. High-quality randomized trials need to be conducted to inform clinical decision making.
Trial registration
PROSPERO 2017 CRD42017080291.
The objective of this study was to catalogue items from instruments used to measure functioning, disability, and contextual factors in patients with low back pain (LBP) treated with manual medicine (manipulation and mobilization) according to the International Classification of Functioning, Disability and Health (ICF). This catalogue will be used to inform the development of an ICF-based assessment schedule for LBP patients treated with manual medicine. In this scoping review we systematically searched MEDLINE, Embase, PsycINFO and CINAHL. We identified instruments (questionnaires, clinical tests, single questions) used to measure functioning, disability and contextual factors, extracted the relevant items and then linked these items to the ICF. We included 95 articles and identified 1510 meaningful concepts. All but 70 items were linked to the ICF. Of the concepts linked to the ICF, body functions accounted for 34.7%, body structures accounted for 0%, activities and participation accounted for 41%, environmental factors accounted for 3.6%, and personal factors accounted for 16%. Most items used to measure functioning and disability in LBP patient treated with manual medicine focus on body functions, and activities and participation. The lack of measures that address environmental factors warrants further investigation.
Objective: Functioning is an important outcome for rheumatoid arthritis (RA) management. Heterogeneity of respective patient-reported outcome measures (PROMs) challenges direct comparisons between their results. This study aimed to standardize reporting of such PROMs measuring functioning in RA to facilitate comparability.
Methods: Common Item Non-Equivalent Groups Design (NEAT) with the Health Assessment Questionnaire (HAQ) as a common scale across data sets from various countries (incl. UK, Turkey and Germany) to establish a common metric. Other PROMs included are the Physical Function items of the Multidimensional Health Assessment Questionnaire (MDHAQ), Disabilities of Arm, Shoulder and Hand (DASH), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), World Health Organization Disability Assessment Schedule Version 2.0 (WHODAS 2.0), and four short forms (20, 10, 6, and 4 physical function items) from the Patient-Reported Outcomes Measurement Information System (PROMIS). As the HAQ includes mobility, self-care and domestic life items, this study focuses on these three domains. PROMs were described using Standard Error of Measurement (SEM) and Smallest Detectable Difference (SDD). Rasch Measurement model was used to create the common metric.
Results: Range of SEM is 0.2 (MDHAQ) to 7.4 (SF36-PF). SDD revealed a range from 9.7 % (WOMAC-RAT) to 33.5 % (WHODAS-PF). PROMs co-calibration revealed fit to the Rasch measurement model. A transformation table was developed to allow exchange between PROMs scores.
Discussion: Scores between the Daily Activity PROMs commonly used in RA can now be compared. Factors such as SEM and SDD help determine choice of PROM in clinical practice and research.
Keywords: Common metric; DASH; Disability and Health; HAQ; International Classification of Functioning; Multidimensional HAQ; PROMIS-SF; Rasch measurement model; Scale banking; WHODAS 2.0; WOMAC.
Introduction: In Germany, all new, innovative medicines are subject to an early benefit assessment by the German Federal Joint Committee with subsequent price negotiation and optional arbitration. The purpose of this study was to identify drivers of negotiated (including arbitrated) prices of new, non-orphan innovative medicines in Germany.
Methods: The analysis considered all non-orphan drugs that underwent a benefit appraisal between January 2011 and June 2016, and displayed a reimbursement price in the German Drug Directory (Lauer-Taxe®) in November 2017. Negotiated annual treatment costs were analyzed with respect to 11 explanatory variables in regression models.
Results: The total sample included 106 non-orphan drugs. The analysis showed a significant and positive association of log-transformed negotiated annual treatment cost of new medicines with log-transformed annual treatment cost of its comparator(s), extent of added benefit, and log-transformed size of the target population. Analyzing the effects of specific endpoints instead of the overall added benefit revealed that the single endpoint with the largest impact on price is adverse events (AEs). Surprisingly, an increase in AEs significantly increased the price. Various subgroup and sensitivity analyses demonstrated the robustness of the results. The adjusted R squared for all models was above 80%.
Conclusions: The analysis was able to confirm that variables whose consideration is mandated by law are, in fact, the key drivers of negotiated prices. Somewhat puzzling, the analysis also found an increase in AEs to move prices significantly upward.
Hintergrund: Die COVID-19-Pandemie ist eine Ausnahmesituation ohne Präzedenz und erforderte zahlreiche Ad-hoc-Anpassungen in den Strukturen und Prozessen der akutstationären Versorgung.
Ziel: Ziel war es zu untersuchen, wie aus Sicht von Führungspersonen und Hygienefachkräften in der Pflege die stationäre Akutversorgung durch die Pandemiesituation beeinflusst wurde und welche Implikationen sich daraus für die Zukunft ergeben.
Methoden: Qualitative Studie bestehend aus semistrukturierten Interviews mit fünf Verantwortlichen des leitenden Pflegemanagements und drei Hygienefachkräften in vier Krankenhäusern in Deutschland. Die Interviews wurden mittels qualitativer Inhaltsanalyse ausgewertet.
Ergebnisse: Die Befragten beschrieben den auf die prioritäre Versorgung von COVID-19-Fällen hin umstrukturierten Klinikalltag. Herausforderungen waren Unsicherheit und Angst bei den Mitarbeiter_innen, relative Ressourcenknappheit von Material und Personal und die schnelle Umsetzung neuer Anforderungen an die Versorgungleistung. Dem wurde durch gezielte Kommunikation und Information, massive Anstrengungen zur Sicherung der Ressourcen und koordinierte Steuerung aller Prozesse durch bereichsübergreifende, interprofessionelle Task Forces begegnet.
Schlussfolgerungen: Die in der COVID-19-Pandemie vorgenommenen Anpassungen zeigen Entwicklungspotenziale für die zukünftige Routineversorgung auf, z. B. könnten neue Arbeits- und Skill Mix-Modelle aufgegriffen werden. Für die Konkretisierung praktischer Implikationen sind vertiefende Analysen der Daten mit zeitlichem Abstand erforderlich.
Objective: Many different assessment tools are used to assess functioning in rehabilitation; this limits the comparability and aggregation of respective data. The aim of this study was to outline the development of an International Classification of Functioning, Disability and Health (ICF)-based interval-scaled common metric for 2 assessment tools assessing activities of daily living: the Functional Independence Measure (FIMTM) and the Extended Barthel Index (EBI), used in Swiss national rehabilitation quality reports.
Methods: The conceptual equivalence of the 2 tools was assessed through their linking to the ICF. The Rasch measurement model was then applied to create a common metric including FIMTM and EBI.
Subjects: Secondary analysis of a sample of 265 neurological patients from 5 Swiss clinics.
Results: ICF linking found conceptual coherency of the tools. An interval-scaled common metric, including FIMTM and EBI, could be established, given fit to the Rasch model in the related analyses.
Conclusion: The ICF-based and interval-scaled common metric enables comparison of patients and clinics functioning outcomes when different activities of daily living tools are used. The common metric can be included in a Standardized Assessment and Reporting System for functioning information in order to enable data aggregation and comparability.
Keywords: Barthel Index; Functional Independence Measure; Rasch Measurement Model; activities of daily living; outcome assessment (healthcare); psychometrics; quality in healthcare; rehabilitation.