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Research Reports |
J Nijs, PT, MSc, MT, is Assistant at the Department of Human Physiology, Faculty of Physical Education and Physical Therapy, Vrije Universiteit Brussel, Brussels, Belgium. Address all correspondence to Mr Nijs at Vakgroep MFAB/Sportgeneeskunde, AZ-VUB KRO Gebouw 1, Laarbeeklaan 101, 1090 Brussels, Belgium (Jo.Nijs{at}vub.ac.be)
P Vaes, PT, PhD, is Professor, Department of Physical Therapy, Faculty of Physical Education and Physical Therapy, Vrije Universiteit Brussel
N McGregor, PhD, MDSc, is Faculty Member, Collaborative Pain Research Unit, Department of Biological Sciences, Faculty of Science, University of Newcastle, Callaghan, New South Wales, Australia
E Van Hoof, Clin Psychol, is Clinical Psychologist, Department of Human Physiology, Faculty of Physical Education and Physical Therapy, Vrije Universiteit Brussel
K De Meirleir, MD, PhD, is Staff Member, Chronic Fatigue Clinic, Vrije Universiteit Brussel, and is Professor and Head, Department of Human Physiology, Faculty of Physical Education and Physical Therapy, Vrije Universiteit Brussel
Submitted August 1, 2002;
Accepted December 3, 2002
| Abstract |
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.95 (P<.001). Discussion and Conclusion. The results substantiate the convergent validity, content validity, and reliability of the CFS-APQ scores for patients with CFS.
Key Words: Activity limitations Chronic fatigue syndrome Participation restrictions Reliability Validity
| Introduction |
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Although the diagnosis of CFS requires severe activity limitations and participation restrictions (problems an individual may experience in involvement in life situations),1,2 no disease-specific measures are currently available to assess these aspects of disability in people with CFS. Exercise capacity testing appears to be valid for monitoring cardiorespiratory fitness,3,4 albeit an expensive and time-consuming option for characterizing a component of CFS. Generic questionnaires, such as the Medical Outcomes Study 36-Item Short-Form Health Status Survey (SF-36),3,5 are widely used in CFS research. The interpretation of data obtained with such generic measures is often difficult and time-consuming (eg, requiring interpretation of scores for 8 different subscales for the SF-36), which prohibits their routine application in practice. Furthermore, we believe that generic measures are unable to characterize all activity limitations and participation restrictions in patients with CFS and consequently have insufficient content validity for this population. These limitations decrease the usefulness of general questionnaires, especially when identifying activity limitations, which we believe is crucial so that patients can be taught to manage their activity levels (also known as "pacing," a strategy where patients are encouraged to achieve an appropriate balance between activity and rest to avoid exacerbations and to set realistic goals for increasing activity). Therefore, an inexpensive, quick, and valid measure to assess activity limitations and participation restrictions in patients with CFS might be of great value, especially to establish goals and to examine the effectiveness of interventions. Indeed, the primary expectation of treatment for patients with less severe disability may not to be to reduce symptoms, but to regain full participation in work and social activities.
Our group recently constructed a disease-specific and time-specific (reflecting the patients' health status during the last 7 days) questionnaire: the Chronic Fatigue SyndromeActivities and Participation Questionnaire (CFS-APQ).6 This new assessment tool was constructed based on self-reported activity limitations and participation restrictions of 141 patients with CFS (a retrospective analysis of over 600 quality-of-life questionnaires).6 In accordance with the World Health Organization's taxonomy, the International Classification of Functioning, Disability and Health,7 our new self-assessment tool is designed to monitor activity limitations and participation restrictions in patients with CFS. In this study, the convergent validity, 2 different aspects of content validity, and reliability of the CFS-APQ scores were examined in 47 patients with CFS.
| Method |
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Patients who did not fulfill the 1994 definition for CFS1 were excluded from the sample. To fulfill the CDC criteria for CFS, unexplained, persistent, or relapsing chronic fatigue that is of new or definite onset should result in a substantial reduction in previous levels of occupational, educational, social, or personal activities.1 Furthermore, at least 4 of the following symptoms must have persisted or recurred during 6 or more consecutive months and must not have predated the fatigue: impairment in short-term memory or concentration, tender cervical or axillary lymph nodes, muscle pain, multijoint pain, headache, unrefreshing sleep, and postexertional malaise lasting longer than 24 hours.1 Any active medical condition that may explain the presence of chronic fatigue prohibits the diagnosis of CFS. All subjects underwent an extensive medical evaluation, consisting of a physical examination, medical history, exercise capacity test, and routine laboratory tests. The laboratory tests included a complete blood cell count; determination of erythrocyte sedimentation rate; a serum electrolyte panel; measures of renal, hepatic, and thyroid function; and rheumatic and viral screens. If the patients' medical history did not include information that excluded a psychiatric problem at the time of disease onset, then a structured psychiatric interview was performed. In a number of cases, further neurological, gynecological, endocrine, cardiac, or gastrointestinal evaluations were performed to fulfill the CDC criteria for CFS. The medical records also were reviewed to determine whether patients had organic or psychiatric illnesses that could explain their symptoms. Furthermore, if patients did not complete more than 50% of the items on the questionnaire appropriately or if they were younger than 18 years of age, they were excluded from the sample. Underaged patients, we believe, have different activity limitations and participation restrictions as compared with adults.
Forty-seven of the 111 study participants fulfilled the inclusion criteria. Demographic features of the sample and descriptive statistics for the visual analog scales (VASs) for pain, fatigue, and ability to concentrate are presented in Table 1. The subjects had a mean age of 36.5 years (SD=11.1, range=1860) and a mean illness duration of 4.8 years (SD=4.9, range=1.028.0), and 39 subjects (83.0%) were female.
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Reliability
Test-retest reliability of data obtained with the self-report instrument was assessed by having the subjects complete a modified version of the questionnaire at home and returning it within 24 hours. The subjects were given a sealed envelope containing the modified version of the questionnaire, an instruction letter, and a stamped, addressed return envelope as they departed from the hospital and were instructed not to open the envelope until they arrived home. The modified version of the CFS-APQ (the retest questionnaire) had different fonts and a different question sequence, including VASs for pain, fatigue, ability to concentrate. The reasoning behind our using this approach was our effort to prevent subjects from replicating their answer sequence rather than responding to the questions. The instruction letter explained the nature and purpose of the research, and again we stipulated that patients were not obliged to participate and that anonymity was guaranteed. The same exclusion criteria were used as we did for the validity analysis.
Validity
To examine the unidemensionality of the questionnaire, the Cronbach alpha coefficient was calculated. To investigate the convergent validity of this new measure, 100-mm VASs for fatigue, pain, and ability to concentrate were used. The pain scores obtained with the VAS are believed to be reliable12,13 and sensitive to change.14 Additionally, before completing the questionnaire, participants were asked to list at least 5 activities or tasks that have become difficult for them to do. All answers were analyzed for their accordance with the contents of the questionnaire. Other researchers have used this method for investigating content validity.15 The CFS-APQ is designed to monitor activity limitations and participation restrictions in patients with CFS. Therefore, every item of the questionnaire was checked in the International Classification of Impairments, Disability and Health (ICIDH) beta II draft16 to examine whether the items of this measurement tool assess activity limitations and participation restrictions. At the time this study was performed, the International Classification of Functioning, Disability and Health (ICF, the latest revision of the ICIDH) was not available. Likewise, frequently reported answers to the open question that did not match the content of the questionnaire were searched in the ICIDH beta II draft.
Data Analysis
Spearman rank correlation coefficients were calculated for the analysis of the data highlighting the convergent validity of the CFS-APQ scores with the VASs for pain, fatigue, and concentration. The significance level was set at .01 to help protect against potential Type I errors. Simple descriptive statistics (frequencies and percentages) were used for the analysis of the content validity data. The test-retest data were assessed using intraclass correlation coefficients (ICCs, two-way mixed model).17 Possible differences in demographic characteristics between the first sample (n=47) and the retest sample (n=34) were assessed using the independent-samples Student t test for equality of means (age and illness duration) and the Fisher exact test (sex).
| Results |
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Table 5 lists all ICCs for the total scores on the questionnaire, the individual questions as well as the VAS scores. The test-retest ICCs of the overall scores on this self-administered measure were .96 (total score 1) and .95 (total score 2). The ICCs of the total scores were >.80, except for the ICCs for questions 6 ("replacing a lightbulb," ICC=.57), 9 ("standing for 1 hour," ICC=.80), and 18 ("reading," ICC=.77). The ICCs for the VAS scores for pain, fatigue, and ability to concentrate between the test and the retest were .83, .82, and .76, respectively.
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| Discussion and Conclusions |
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Validity
The Cronbach alpha coefficient was .94 for both total scores, suggesting a high degree of consistency among the different items. Consequently, the calculated Cronbach alpha coefficients suggest that the different items of the questionnaire measure the same construct. These data suggest sufficient convergent validity of the CFS-APQ scores with VASs for pain and fatigue. The way the CFS-APQ was constructed, based on self-reported activity limitations and participation restrictions of 141 patients with CFS,6 supports disease specificity and content validity of this new measure. In our study, 47 participants with CFS reported 183 activities that became difficult to do, and the majority (157 responses [85.8%]) complied with the content of the questionnaire (ie, the answers were found in the content of the questionnaire). The most prevalent of the nonfitting items ("sleeping") is a mental function, indicating it is unsuitable for a questionnaire aiming at monitoring activity limitations and participation restrictions. These results, we believe, substantiate the comprehensiveness of item selection. In addition, reviewing the content of the CFS-APQ in the ICIDH beta II draft indicated that this measure focuses on the activity and participation domains.
Our results should be interpreted with some caution. The reliability and validity of scores obtained with the Dutch version of the CFS-APQ were assessed. No data are currently available to validate the English version of this questionnaire (Appendix). The patients included in this study and those used for constructing the questionnaire6 all fulfilled the current American definition for CFS.1 Because of the assumed socioeconomic similarities between American and Belgian citizens, the content of the Dutch CFS-APQ is likely to represent the most frequent activity limitations and participation restrictions in American patients with CFS. In Belgium, where predominantly Dutch- and French-speaking patients are seen in practice, validation of an English version is nearly impossible. We hope our report will convince English-speaking physical therapists that it would be worthwhile to investigate psychometric properties of the English version of the CFS-APQ.
Our questionnaire was designed to establish goals and outcomes of physical therapists' interventions. Our reliability data were obtained using mail for response. Therefore, we cannot be sure that each participant completed the questionnaire without assistance or within 24 hours following the first scoring. This is particularly relevant because a number of questionnaires were returned up to 5 weeks after the participants' initial visit to the Chronic Fatigue Clinic. The use of a mailed questionnaire may have biased the reliability analysis because we may have collected data from only highly motivated respondents. Our sample was derived from consecutive patients and was not randomly selected, and this also is a limitation. The questionnaire was given to all patients with CFS visiting the Chronic Fatigue Clinic of the Vrije Universiteit Brussels; therefore, we relied on a sample of convenience. Selection bias can only be due to appointment scheduling, but our secretaries were blinded to patients' medical records when they scheduled the appointments. Moreover, a sample consisting of consecutive patients visiting a clinic is more likely to represent routine clinical practice.
Our combining 2 different, but related, constructs (the satisfaction and importance verification of each question) might be inappropriate. Because the total score 1 as well as total score 2 (using only the satisfaction part) appeared to be reliable and valid, we believe this is unlikely to be the case. Likewise, the assumption that all item scores of the CFS-APQ can be summed together implies to us that activity limitations and participation restrictions represent a one-dimensional construct. The revised World Health Organization's classification system (the ICF) combines activities and participation into one health-related domain. This indicates to us that the data from the CFS-APQ represent a one-dimensional construct. However, dimensionality studies of the CFS-APQ that can support the interpretation of a one-dimensional construct are currently lacking.
In general, self-report questionnaires offer an easy and inexpensive way to monitor the patient's perceived quality of life, which cannot be offered by laboratory data.20 In our opinion, the use of this self-administered assessment tool, which acknowledges that people value things differently, should enable physical therapists to treat the patient rather than treating the disease. Indeed, we believe that because of the incorporation of importance verification to each item in the questionnaire, this health status instrument can be used to monitor at least a part of patients' expectations for care.
Our data, we argue, provide evidence for sufficient test-retest reliability, convergent validity, and 2 different aspects of content validity of the scores obtained with the Dutch CFS-APQ. Before the use of this new measure in clinical practice and research settings can be advised, however, responsiveness and other forms of validity should be examined.
| Appendix |
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| Footnotes |
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* The English version of the CFS-APQ is shown in the Appendix. The Dutch version of the questionnaire (as well as a French version) is available upon request from the corresponding author. ![]()
| References |
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This article has been cited by other articles:
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J. Nijs, K. Van de Putte, F. Louckx, and K. De Meirleir Employment status in chronic fatigue syndrome. A cross-sectional study examining the value of exercise testing and self-reported measures for the assessment of employment status Clinical Rehabilitation, August 1, 2005; 19(8): 895 - 899. [Abstract] [PDF] |
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J. Nijs, K. Vanherberghen, W. Duquet, and K. De Meirleir Chronic Fatigue Syndrome: Lack of Association Between Pain-Related Fear of Movement and Exercise Capacity and Disability Physical Therapy, August 1, 2004; 84(8): 696 - 705. [Abstract] [Full Text] [PDF] |
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J. Nijs and K. De Meirleir Prediction of peak oxygen uptake in patients fulfilling the 1994 CDC criteria for chronic fatigue syndrome Clinical Rehabilitation, July 1, 2004; 18(7): 785 - 792. [Abstract] [PDF] |
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J Nijs, K De Meirleir, S Wolfs, and W Duquet Disability evaluation in chronic fatigue syndrome: associations between exercise capacity and activity limitations/participation restrictions Clinical Rehabilitation, February 1, 2004; 18(2): 139 - 148. [Abstract] [PDF] |
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