Category: Methodology

Measuring disability in patients with chronic fatigue syndrome: reliability and validity of the Work and Social Adjustment Scale

Abstract:

BACKGROUND: Disability is a defining feature of chronic conditions, and it is an increasingly used measure of therapy effectiveness. The Work and Social Adjustment Scale (WSAS) is a simple and clear measure of disability. Although the scale is widely used, no study has yet investigated its psychometric properties in patients with chronic fatigue syndrome (CFS).

METHODS: Data from two samples of patients were used, one from a multicenter randomized controlled clinical trial of treatments for CFS (n =639) and the other from a clinic that specializes in CFS (n=384). All patients completed the WSAS as well as other measures.

RESULTS: Internal consistency and the Spearman-Brown split-half coefficient values indicated that the scale is reliable. CFS patients who had comorbid diagnoses of depression, anxiety or fibromyalgia had higher WSAS scores. High levels of disability were associated with high number of physical symptoms, severe fatigue, depression, anxiety, poor sleep quality and poor physical fitness, with correlation coefficients ranging between 0.41 and 0.11. Lower scores on the WSAS were modestly associated with better physical functioning as well as higher levels of physical capacity as assessed by a walking test. Sensitivity to change was evaluated in a subgroup of patients who had undergone a course of cognitive behavioral therapy. Disability significantly decreased after therapy and remained stable at follow-ups.

CONCLUSION: The WSAS is a reliable and valid assessment tool for disability in patients with CFS.

Copyright © 2011 Elsevier Inc. All rights reserved.

 

Source: Cella M, Sharpe M, Chalder T. Measuring disability in patients with chronic fatigue syndrome: reliability and validity of the Work and Social Adjustment Scale. J Psychosom Res. 2011 Sep;71(3):124-8. doi: 10.1016/j.jpsychores.2011.02.009. Epub 2011 Apr 3. https://www.ncbi.nlm.nih.gov/pubmed/21843745

 

Multi-source synthesis of data to inform health policy

Abstract:

OBJECTIVES: To propose a new method for comparing and integrating original qualitative data with systematic reviews of quantitative and qualitative studies, demonstrated by a study of the psychosocial needs of chronic fatigue syndrome (CFS) sufferers in Québec.

METHODS: A systematic literature review was performed across various databases for English and French language studies, on the psychosocial aspects of CFS. Qualitative, quantitative, and mixed method studies published between January 1994 and July 2008 were included. Unpublished literature and reference lists of included studies were also searched. Themes identified in the literature were used to guide semi-structured interviews with seventeen CFS-sufferers, mostly recruited from a large specialist practice in Montreal. Interviews were transcribed verbatim and validated by a research assistant. Transcripts were coded using the identified themes. New codes were created when new issues arose. All themes were subsequently synthesized into overall categories using a constant comparative method.

RESULTS: The literature search yielded thirty-one papers: twenty-eight primary studies and three systematic reviews. Twelve themes were identified and synthesized into four overall problem categories, such as “Lack of professional recognition.” Interviews confirmed findings from the literature, but also revealed unidentified needs specific to CFS-sufferers in Québec. Policy recommendations were provided to address these needs.

CONCLUSIONS: Multi-Source Synthesis provides a systematic method for synthesizing data from original studies with literature findings, thereby broadening the knowledge base and the local relevance of decisions concerning specific patient populations.

 

Source: Pedersen VH, Dagenais P, Lehoux P. Multi-source synthesis of data to inform health policy. Int J Technol Assess Health Care. 2011 Jul;27(3):238-46. doi: 10.1017/S0266462311000213. Epub 2011 Jul 8. https://www.ncbi.nlm.nih.gov/pubmed/21736858

 

Reliability and validity of Short Form 36 Version 2 to measure health perceptions in a sub-group of individuals with fatigue

Abstract:

PURPOSE: To determine the validity and reliability of Short Form 36 Version 2 (SF36v2) in sub-groups of individuals with fatigue.

METHOD: Thirty subjects participated in this study, including n = 16 subjects who met case definition criteria for chronic fatigue syndrome (CFS) and n = 14 non-disabled sedentary matched control subjects. SF36v2 and Multidimensional Fatigue Inventory (MFI-20) were administered before two maximal cardiopulmonary exercise tests (CPETs) administered 24 h apart and an open-ended recovery questionnaire was administered 7 days after CPET challenge. The main outcome measures were self-reported time to recover to pre-challenge functional and symptom status, frequency of post-exertional symptoms and SF36v2 sub-scale scores.

RESULTS: Individuals with CFS demonstrated significantly lower SF36v2 and MFI-20 sub-scale scores prior to CPET. Between-group differences remained significant post-CPET, however, there were no significant group by test interaction effects. Subjects with CFS reported significantly more total symptoms (p < 0.001), as well as reports of fatigue (p < 0.001), neuroendocrine (p < 0.001), immune (p < 0.01), pain (p < 0.01) and sleep disturbance (p < 0.01) symptoms than control subjects as a result of CPET. Many symptom counts demonstrated significant relationships with SF36v2 sub-scale scores (p < 0.05). SF36v2 and MFI-20 sub-scale scores demonstrated significant correlations (p < 0.05). Various SF36v2 sub-scale scores demonstrated significant predictive validity to identify subjects who recovered from CPET challenge within 1 day and 7 days (p < 0.05). Potential floor effects were observed for both questionnaires for individuals with CFS.

CONCLUSION: Various sub-scales of SF36v2 demonstrated adequate reliability and validity for clinical and research applications. Adequacy of sensitivity to change of SF36v2 as a result of a fatiguing stressor should be the subject of additional study.

 

Source: Davenport TE, Stevens SR, Baroni K, Van Ness JM, Snell CR. Reliability and validity of Short Form 36 Version 2 to measure health perceptions in a sub-group of individuals with fatigue. Disabil Rehabil. 2011;33(25-26):2596-604. doi: 10.3109/09638288.2011.582925. Epub 2011 Jun 20. https://www.ncbi.nlm.nih.gov/pubmed/21682669

 

Quality and acceptability of patient-reported outcome measures used in chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME): a systematic review

Abstract:

PURPOSE: To review the quality and acceptability of condition-specific, domain-specific and generic multi-item patient-reported outcome measures (PROMs) used in the assessment of adults with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME).

METHODS: Systematic literature searches were made to identify PROMs. Quality and acceptability was assessed against an appraisal framework, which captured evidence of both the thoroughness and results of evaluations: evidence of measurement (reliability, validity, responsiveness, interpretability, data quality/precision) and practical properties (feasibility, patient acceptability), and the extent of active patient involvement was sought.

RESULTS: A total of 11 CFS/ME-specific, 55 domain-specific and 11 generic measures were reviewed. With the exception of the generic SF-36, all measures had mostly limited evidence of measurement and/or practical properties. Patient involvement was poorly reported and often cursory.

CONCLUSIONS: The quality and acceptability of reviewed PROMs is limited, and recommendations for patient-reported assessment are difficult. Significant methodological and quality issues in PROM development/evaluation were identified by the appraisal framework, which must be addressed in future research. Clear discrepancies exist between what is measured in research and how patients define their experience of CFS/ME. Future PROM development/evaluation must seek to involve patients more collaboratively to measure outcomes of importance using relevant and credible methods of assessment.

 

Source: Haywood KL, Staniszewska S, Chapman S. Quality and acceptability of patient-reported outcome measures used in chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME): a systematic review. Qual Life Res. 2012 Feb;21(1):35-52. doi: 10.1007/s11136-011-9921-8. Epub 2011 May 18. https://www.ncbi.nlm.nih.gov/pubmed/21590511

 

Classifying medication use in clinical research

Abstract:

BACKGROUND: Medication use data are usually collected in clinical research. Yet no standardized method for categorizing these exists, either for sample description or for the study of medication use as a variable.

OBJECTIVE: The present investigation was designed to develop a simple, empirically based classification scheme for medication use categorization.

METHOD: The authors used factor analysis to reduce the number of possible medication groupings. This permitted a pattern of medication usage to emerge that appeared to characterize specific clinical constellations. To illustrate the technique’s potential, the authors applied this classification system to samples where sleep disorders are prominent: chronic fatigue syndrome and sleep apnea.

RESULTS: The authors’ classification approach resulted in 5 factors that appear to cohere in a logical fashion. These were labeled Cardiovascular or Metabolic Syndrome Medication, Symptom Relief Medication, Psychotropic Medication, Preventative Medication, and Hormonal Medication.

CONCLUSIONS: The findings show that medication profile varies according to clinical sample. The medication profile for participants with sleep apnea reflects known comorbid conditions; the medication profile associated with chronic fatigue syndrome appears to reflect the common perception of this condition as a psychogenic disorder.

 

Source: Rizzo D, Creti L, Bailes S, Baltzan M, Grad R, Amsel R, Fichten CS, Libman E. Classifying medication use in clinical research. J Prim Care Community Health. 2011 Jan 1;2(1):26-32. doi: 10.1177/2150131910385843. Epub 2010 Oct 27. https://www.ncbi.nlm.nih.gov/pubmed/23804659

 

Measuring fatigue in clinical and community settings

Abstract:

OBJECTIVE: The Chalder Fatigue Scale (CFQ) is a widely used instrument to assess fatigue in both clinical and nonclinical settings. Psychometric properties of the scale and discriminative abilities were examined.

METHODS: A total of 361 patients with CFS and 1615 individuals in the community were assessed with the CFQ. Principal component analysis (PCA) was used to explore the structure of the scale. Receiver-operating characteristic curve (ROC) was used to investigate the discriminative properties.

RESULTS: Two components, physical and mental fatigue, were identified in the CFS patient group and in the general population samples. Area under the curve for ROC was .91. The fatigue scale effectively discriminates, at high scores, between CFS patients and the general population.

CONCLUSION: Physical and mental fatigue are clearly separable components of fatigue. The CFQ can discriminate reliably between clinical and nonclinical conditions.

Copyright (c) 2010 Elsevier Inc. All rights reserved.

 

Source: Cella M, Chalder T. Measuring fatigue in clinical and community settings. J Psychosom Res. 2010 Jul;69(1):17-22. doi: 10.1016/j.jpsychores.2009.10.007. Epub 2009 Dec 11. https://www.ncbi.nlm.nih.gov/pubmed/20630259

 

Measuring substantial reductions in functioning in patients with chronic fatigue syndrome

Abstract:

PURPOSE: All the major current case definitions for chronic fatigue syndrome (CFS) specify substantial reductions in previous levels of occupational, educational, social, or personal activities to meet criteria. Difficulties have been encountered in operationalizing ‘substantial reductions.’ For example, the Medical Outcomes Study Short Form-36 Health Survey (SF-36) has been used to determine whether individuals met the CFS disability criterion. However, previous methods of using the SF-36 have been prone to including people without substantial reductions in key areas of physical functioning when diagnosing CFS. This study sought to empirically identify the most appropriate SF-36 subscales for measuring substantial reductions in patients with CFS.

METHOD: The SF-36 was administered to two samples of patients with CFS: one recruited from tertiary care and the other a community-based sample; as well as a non-fatigued control group. Receiver operating characteristics were used to determine the optimal cutoff scores for identifying patients with CFS.

RESULTS: The SF-36 Role-Emotional subscale had the worst sensitivity and specificity, whereas the Vitality, Role-Physical, and Social Functioning subscales had the best sensitivity and specificity.

CONCLUSION: Based on the evidence from this study, the potential criteria for defining substantial reductions in functioning and diagnosing CFS is provided.

© 2011 Informa UK, Ltd.

 

Source: Jason L, Brown M, Evans M, Anderson V, Lerch A, Brown A, Hunnell J, Porter N. Measuring substantial reductions in functioning in patients with chronic fatigue syndrome. Disabil Rehabil. 2011;33(7):589-98. doi: 10.3109/09638288.2010.503256. Epub 2010 Jul 9. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3170036/ (Full article)

 

The PRIME project: developing a patient evidence-base

Abstract:

BACKGROUND: The concept of evidence has become firmly rooted in health care, with most importance placed on the outcome of research in clinical and economic spheres. Much less emphasis is placed on the patient’s contribution to evidence which remains relatively vague, of low status and often difficult to integrate with other forms of knowledge.

AIM: This article proposes a concept of patient-based evidence, to complement clinical and economic forms of evidence, and demonstrates one way in which it has been operationalized. The PRIME project developed a patient evidence-base to capture the lived experience of individuals with myalgic encephalitis (ME) or chronic fatigue syndrome (CFS).

DESIGN: Interviews were performed with 40 individuals with ME/CFS who varied in a range of demographic characteristics, including age, gender, and how severely affected individuals were.

RESULTS: PRIME has developed a patient evidence-base which has an extensive array of experiences data to provide researchers, clinicians and others with an in-depth insight into the lived experience of ME/CFS that can be used and analysed. Data are grouped into a wide range of themes, which can be downloaded and used in a variety of ways as a source of evidence to enable understanding of the lived experience of ME/CFS and so contribute to the development of a more patient-focused research agenda in ME/CFS.

CONCLUSIONS: While patient-based evidence used in the PRIME Project provides a useful start, further work is required to develop this area conceptually and methodologically, particularly in relation to how patient-based evidence can be considered alongside clinical and economic evidence.

 

Source: Staniszewska S, Crowe S, Badenoch D, Edwards C, Savage J, Norman W. The PRIME project: developing a patient evidence-base. Health Expect. 2010 Sep;13(3):312-22. doi: 10.1111/j.1369-7625.2010.00590.x. Epub 2010 Jun 23. https://www.ncbi.nlm.nih.gov/pubmed/20579119

 

Impaired sleep in chronic fatigue syndrome: how is it best measured?

Abstract:

The goal was to examine comparative efficacy of polysomnography, actigraphy, and self-report in evaluating the sleep/wake experience of individuals with chronic fatigue syndrome (CFS). Sleep parameters were evaluated by the three measurement modalities for the same night in 49 participants with CFS. Psychological and daytime functioning were measured by self-report. Results indicate that: (a) objectively measured nocturnal sleep time effectively approximated subjective experience although nocturnal wakefulness did not; (b) total sleep time and sleep efficiency differentiated individuals with and without insomnia complaints; (c) daytime sleepiness, fatigue, and non-refreshing sleep were not reflected by the objective sleep-related measures (polysomnography and actigraphy).

 

Source: Creti L, Libman E, Baltzan M, Rizzo D, Bailes S, Fichten CS. Impaired sleep in chronic fatigue syndrome: how is it best measured? J Health Psychol. 2010 May;15(4):596-607. Doi: 10.1177/1359105309355336. https://www.ncbi.nlm.nih.gov/pubmed/20460416

 

Is the International Physical Activity Questionnaire-short form (IPAQ-SF) valid for assessing physical activity in Chronic Fatigue Syndrome?

Abstract:

PURPOSE: To evaluate the criterion validity and internal consistency of the International Physical Activity Questionnaire-short form (IPAQ-sf) in Chronic Fatigue Syndrome (CFS) patients.

METHOD: Fifty-six CFS patients completed the IPAQ-sf after they wore a tri-axial accelerometer and filled out activity diaries during 1 week. Spearman rank correlation coefficients and Cronbach’s Alpha were calculated.

RESULTS: The IPAQ-sf correlated significantly with the energy expenditure and Metabolic Equivalents (METs) minutes spent moderately to vigorously active following the activity diary and accelerometer. These correlation coefficients were however low (r varying between 0.282 and 0.426) and rather irrelevant, since CFS patients hardly reach moderate or vigorous activity levels. Internal consistency between the three subitems used for the total score of the IPAQ-sf was 0.337.

CONCLUSION: The observed associations between the IPAQ-sf data and the data obtained from the accelerometer (gold standard) and the diaries were too low to be in support of the use of the IPAQ-sf in patients with CFS. The IPAQ-sf does not seem an appropriate tool to assess physical activity in CFS patients. Further study is required to seek for a valid, practical and affordable tool.

 

Source: Meeus M, Van Eupen I, Willems J, Kos D, Nijs J. Is the International Physical Activity Questionnaire-short form (IPAQ-SF) valid for assessing physical activity in Chronic Fatigue Syndrome? Disabil Rehabil. 2011;33(1):9-16. doi: 10.3109/09638288.2010.483307. Epub 2010 May 6. https://www.ncbi.nlm.nih.gov/pubmed/20446802