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      Minimal important differences for fatigue patient reported outcome measures—a systematic review

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          Abstract

          Background

          Fatigue is the most frequent symptom reported by patients with chronic illnesses. As a subjective experience, fatigue is commonly assessed with patient-reported outcome measures (PROMs). Currently, there are more than 40 generic and disease-specific PROMs for assessing fatigue in use today. The interpretation of changes in PROM scores may be enhanced by estimates of the so-called minimal important difference (MID). MIDs are not fixed attributes of PROMs but rather vary in relation to estimation method, clinical and demographic characteristics of the study group, etc. The purpose of this paper is to compile published MIDs for fatigue PROMs, spanning diagnostic/patient groups and estimation methods, and to provide information relevant for appraising their appropriateness for use in specific clinical trials and in monitoring fatigue in defined patient groups in routine clinical practice.

          Methods

          A systematic search of three databases (Scopus, CINAHL and Cochrane) for studies published between January 2000 to April 2015 using fatigue and variations of the term MID, e.g. MCID, MIC, etc. Two authors screened search hits and extracted data independently. Data regarding MIDs, anchors used and study designs were compiled in tables.

          Results

          Included studies ( n = 41) reported 60 studies or substudies estimating MID for 28 fatigue scales, subscales or single item measures in a variety of diagnostic groups and study designs. All studies used anchor-based methods, 21/60 measures also included distribution-based methods and 17/60 used triangulation of methods. Both similarities and dissimilarities were seen within the MIDs.

          Conclusions

          Magnitudes of published MIDs for fatigue PROMs vary considerably. Information about the derivation of fatigue MIDs is needed to evaluate their applicability and suitability for use in clinical practice and research.

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          Most cited references55

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          Measurement of health status. Ascertaining the minimal clinically important difference.

          In recent years quality of life instruments have been featured as primary outcomes in many randomized trials. One of the challenges facing the investigator using such measures is determining the significance of any differences observed, and communicating that significance to clinicians who will be applying the trial results. We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change. Using this approach we have established a plausible range within which the minimal clinically important difference (MCID) falls. In three studies in which instruments measuring dyspnea, fatigue, and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item, when responses were presented on a seven point Likert scale. Furthermore, we have established ranges for changes in questionnaire scores that correspond to moderate and large changes in the domains of interest. This information will be useful in interpreting questionnaire scores, both in individuals and in groups of patients participating in controlled trials, and in the planning of new trials.
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            Dimensional assessment of chronic fatigue syndrome.

            The absence of laboratory tests and clear criteria to identify homogeneous (sub)groups in patients presenting with unexplained fatigue, and to assess clinical status and disability in these patients, calls for further assessment methods. In the present study, a multi-dimensional approach to the assessment of chronic fatigue syndrome (CFS) is evaluated. Two-hundred and ninety-eight patients with CFS completed a set of postal questionnaires that assessed the behavioural, emotional, social, and cognitive aspects of CFS. By means of statistical analyses nine relatively independent dimensions of CFS were identified along which CFS-assessment and CFS-research can be directed. These dimensions were named: psychological well-being, functional impairment in daily life, sleep disturbances, avoidance of physical activity, neuropsychological impairment, causal attributions related to the complaints, social functioning, self-efficacy expectations, and subjective experience of the personal situation. A description of the study sample on these dimensions is presented.
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              The experiences of professionals with using information from patient-reported outcome measures to improve the quality of healthcare: a systematic review of qualitative research.

              To synthesise qualitative studies that investigated the experiences of healthcare professionals with using information from patient-reported outcome measures (PROMs) to improve the quality of care. A qualitative systematic review was conducted by searching PubMed, PsycINFO and CINAHL with no time restrictions. Hand searching was also performed. Eligible studies were evaluated using the Critical Appraisal Skills Programme toolkit for qualitative studies. A thematic synthesis identified common themes across studies. Study characteristics were examined to explain differences in findings. All healthcare settings. Healthcare professionals. Professionals' views of PROMs after receiving PROMs feedback about individual patients or groups of patients. Sixteen studies met the inclusion criteria. Barriers and facilitators to the use of PROMs emerged within four main themes: collecting and incorporating the data (practical), valuing the data (attitudinal), making sense of the data (methodological) and using the data to make changes to patient care (impact). Professionals value PROMs when they are useful for the clinical decision-making process. Practical barriers to the routine use of PROMs are prominent when the correct infrastructure is not in place before commencing data collection and when their use is disruptive to normal work routines. Technology can play a greater role in processing the information in the most efficient manner. Improvements to the interpretability of PROMs should increase their use. Attitudes to the use of PROMs may be improved by engaging professionals in the planning stage of the intervention and by ensuring a high level of transparency around the rationale for data collection. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
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                Author and article information

                Contributors
                +46 707 521226 , anna.dencker@gu.se
                Journal
                BMC Med Res Methodol
                BMC Med Res Methodol
                BMC Medical Research Methodology
                BioMed Central (London )
                1471-2288
                26 May 2016
                26 May 2016
                2016
                : 16
                : 62
                Affiliations
                [ ]Gothenburg Centre for Person-Centred Care (GPCC), Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
                [ ]Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
                [ ]Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
                Article
                167
                10.1186/s12874-016-0167-6
                4937582
                27387456
                bac4c7ce-8f4b-4ae9-9e18-5581b854daaa
                © The Author(s). 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 23 December 2015
                : 17 May 2016
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2016

                Medicine
                mid,fatigue,prom,minimal important difference,systematic review,mcid,mcii
                Medicine
                mid, fatigue, prom, minimal important difference, systematic review, mcid, mcii

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