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Monitoring Disease Activity in Multiple Sclerosis
Published in Richard K. Burt, Alberto M. Marmont, Stem Cell Therapy for Autoimmune Disease, 2019
The use of defined measures of disease relapses or disability progression became increasingly important as large scale studies were done to assess the efficacy of new therapies. Instruments used for clinical outcome measures must be assessed for reliability, validity and sensitivity. One must also consider their clinical usefulness including time to administer the test, ease of use, patient tolerability and training requirements. Interrater and intrarater reliability is especially important in MS clinical trials, as change in neurologic examination becomes the primary end-point of these studies. It is especially important that the instrument not falsely contribute to measures of disease progression or improvement. The instrument must detect small but significant changes.1
Critical Appraisal Skills
Published in John C Watkinson, Raymond W Clarke, Louise Jayne Clark, Adam J Donne, R James A England, Hisham M Mehanna, Gerald William McGarry, Sean Carrie, Basic Sciences Endocrine Surgery Rhinology, 2018
Paul Nankivell, Christopher Coulson
To determine the impact of an intervention on patient health, one needs to define clearly the outcome that needs to be measured. This sounds straightforward enough but it can take up a larger amount of the preparation time of the research. An outcome measure is any feature that is recorded to determine the progression of the disease or problem being studied. In this paper a comprehensive questionnaire was used to determine outcomes.
Human factors, patient safety and quality improvement
Published in Professor Sir Norman Williams, Professor P. Ronan O’Connell, Professor Andrew W. McCaskie, Bailey & Love's Short Practice of Surgery, 2018
Professor Sir Norman Williams, Professor P. Ronan O’Connell, Professor Andrew W. McCaskie
Outcome indicators are specific, observable and measurable changes that represent the achievement of an outcome of a quality improvement measure. Clinical outcome measures refer specifically to outcomes of healthcare interventions whether they are to do with diagnosis, treatment or that care received by service users. Ideally, they should be outcomes that are important to patients rather than to the health provider, and there should be evidence that they reflect the quality of the interventions and their effect. Outcome measures are what are commonly used in clinical audit when compared with evidenced-based standards of clinical care.
Test–retest reliability of the L-Test in patients with advanced knee osteoarthritis
Published in Physiotherapy Theory and Practice, 2022
Abdurrahman Nalbant, Bayram Unver, Vasfi Karatosun
The reliable and valid measurement of outcome measures is crucial in both research and clinical practice (Dobson et al., 2017). Reliability provides information about how consistent and repeatable the measurements are. It is an essential feature of a meaningful measurement (Gadotti, Vieira, and Magee, 2006). It can be defined as the consistency of a measurement tool. The margin of error that can always be seen in continuous measurements is in accordance with the accepted measurement error. It is important for the effective and practical use of the measuring tool. Reliability should be tested for first in a new measurement tool since it will never be valid if it is not adequately consistent with whatever value it indicates from repeated measurements (Atkinson and Nevill, 1998). There are different types of reliability like test–retest, intra-rater, and inter-rater.
Multiarm study comparing patient-reported and clinical outcome measures in patients undergoing antipsoriatic therapy with non-biological systemic agents in a real-world setting
Published in Journal of Dermatological Treatment, 2022
Christine Fink, Christina Alt, Timo E. Schank, Katharina Sies, Samuel Kilian, Knut Schäkel
In conclusion, this real-life study demonstrates the outstanding importance of patient-reported outcome measures in clinical trials. The need to differentiate between clinical and patient-reported outcome measures was illustrated by several points. For instance, the treatment effectiveness was rated almost equally by patients of all three study groups by means of the TSQM. However, objectively, apremilast showed a worse PASI response compared to fumaric acids and methotrexate. Moreover, despite a considerably increased side-effect rate in the fumaric acids group leading to therapy interruption, side-effects were rated only slightly worse in the TSQM questionnaire compared to the two other groups. These study findings indicate that an adequate assessment of antipsoriatic drugs by PASI-reduction alone is not sufficient and underline the importance of patient-reported outcome measures not only in clinical trials, but also as a parameter to establish improved patient care.
A concept analysis and overview of outcome measures used for evaluating patients with proximal humerus fractures
Published in Disability and Rehabilitation, 2021
Lauren L. Nowak, Aileen M. Davis, Muhammad Mamdani, Dorcas Beaton, Emil H. Schemitsch
Previous studies have evaluated frequency of use and concepts of some outcome measures used in studies of patients with shoulder disorders [18,83,84]. While there is some overlap with the information reported in these studies, our study is a valuable addition to the literature for several reasons. The Outcome Measures in Rheumatology Shoulder Core Outcome Special Interest Group conducted a systematic review of outcome measures and outcome concepts used in randomized trials of patients with shoulder disorders [18]. However, the authors focused only on the concept that the developers intended the measures to reflect, not the actual content of the measures. In contrast, our study provides a concise overview of the concepts represented by the items of each measure. Second, Roe et al. [83] used the established ICF linking rules to assess the concepts reflected by 17 shoulder-specific measures used in studies of patients with shoulder pain. However, the linking rules allow a single item to be linked to more than one concept, and do not distinguish between Activity Limitations and Participation Restrictions. In addition, these authors did not include any general health state or other measures. Our study outlines the overarching concepts represented by all existing measures on an item-by-item basis, differentiating between Activity Limitations and Participation Restrictions. This information can be used by clinicians and researchers to select outcome measures based on concepts important to relevant stakeholders, and how the items of outcome measures reflect these concepts.