Outcome measurement in functional somatic syndromes: SF-36 summary scores and some scales were not valid
Open accessAbstract
OBJECTIVE: This study aimed to test the validity of the 36-item Short-Form Health Survey (SF-36) scales and summaries in patients with severe functional somatic syndromes (FSS), such as fibromyalgia and irritable bowel syndrome. STUDY DESIGN AND SETTING: One hundred twenty patients with severe FSS enrolled in a randomized controlled trial filled in the SF-36 questionnaire. We tested for data quality, central scaling assumptions, and agreement with the conceptual model. RESULTS: Most SF-36 scales were found to be valid; however, three scales (role physical, role emotional, and general health) did not satisfy predefined criteria for construct validity, internal consistency, or targeting to the sample. The correlations between SF-36 scales differed considerably from those reported in the general population. As a consequence, the SF-36 summaries, physical component summary (PCS) and mental component summary (MCS), did not accurately reflect their underlying scales and were negatively correlated (r=-0.46, 95% CI [-0.60 to -0.31]). CONCLUSION: Although the SF-36 is a valuable instrument to assess perceived health in patients with severe FSS, there are problems with some of the scales and with the scoring procedure of the summaries. The SF-36 PCS may, therefore, not accurately measure the physical health status of these patients. Alternative summary measures are needed.
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A study has suggested that some subscales of the physical component summary of the SF-36 are not valid in patients with functional somatic disorders.
“However, a study has suggested that some subscales of the PSC is not valid in patients with FSD [36]”
From Internet-delivered treatment for patients suffering from severe functional somatic disorders: Protocol for a randomized controlled trial (2023) · cites this paper as [36]
The Key findings report that three SF-36 scales contributing substantially to the physical component summary failed basic scaling assumptions. The study examined patients with severe functional somatic syndromes, so it does not establish the claim for patients with functional somatic disorders more generally. (LLM, conf=0.83)
Experimental — accuracy not yet measuredThe SF-36 aggregate score has previously been used as the primary outcome in a comparable trial in adults due to well-known psychometric problems with the existing physical component score (PCS) and based on the rationale that these three subscales have shown to be key domains affected in this patient group.
“This score has previously been used as the primary outcome in a comparable trial in adults39 due to well-known psychometric problems with the existing physical component score (PCS)73 and based on the rationale that these three subscales have shown to be key domains affected in this patient group.74”
From Comparing group-based acceptance and commitment therapy (ACT) with enhanced usual care for adolescents with functional somatic syndromes: A study protocol for a randomised trial (2016) · cites this paper as [73]
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredThe SF-36 subscales PF, BP and VT have shown to be valid outcome measures in adult patients with severe FSS.
“The primary outcome was the aggregate score ‘physical health’ derived from The 36-Item Short Form Health Survey (SF-36) subscales PF (physical functioning), BP (bodily pain) and VT (vitality) which all have shown to be valid outcome measures in adult patients with severe FSS [56].”
From Feasibility of group-based acceptance and commitment therapy for adolescents (AHEAD) with multiple functional somatic syndromes: A pilot study (2020) · cites this paper as [56]
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Self-citationPetersen, M. W., Skovenborg, E. L., Rask, C. U., Høeg, M. D., Ørnbøl, E., & Schröder, A. (2017) · Journal of Psychosomatic Research · doi:10.1016/j.jpsychores.2017.11.005 · Cited by 13 · see citing works
Self-citationHsiao, Y., Shih, C., Yu, W.-H., Hsieh, C., & Hsieh, C. (2014) · Quality of Life Research · doi:10.1007/s11136-014-0771-z · Cited by 11 · see citing works
Effects of Dapagliflozin on Health-Related Quality of Life in Patients with CKD
Bakker, W. M., Heerspink, H. J. L., Jongs, N., Correa‐Rotter, R., Rossing, P. R., Toto, R. D., Wheeler, D. C., McMurray, J. J. V., Langkilde, A. M., Gansevoort, R. T., et al. (2025) · Journal of the American Society of Nephrology · doi:10.1681/asn.0000000776 · Cited by 8 · see citing works
Psychometric Evaluation of the Brunei-Malay SF-36 version 2 Health Survey
Alhaji, M. M., Johan, N. H., Sharbini, S. H., Hamid, M. R. W. A., Khalil, M. A. M., Tan, J. C., Naing, L., & Tuah, N. A. (2018) · Europe PMC (PubMed Central) · doi:10.22034/apjcp.2018.19.7.1859 · Cited by 7 · see citing works
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Pedersen, H. F., Lamm, T. T., Fink, P., Ørnbøl, E., & Frostholm, L. (2023) · Contemporary Clinical Trials Communications · doi:10.1016/j.conctc.2023.101069 · Cited by 4 · see citing works
“However, a study has suggested that some subscales of the PSC is not valid in patients with FSD [36], and therefore we have chosen to Fig.”
BackgroundSelf-citationJespersen, C. P., Pedersen, H. F., Kleinstäuber, M., Fink, P., Wellnitz, K. B., Ørnbøl, E., Schröder, A., Agger, J. L., Vase, L., Finnerup, N. B., et al. (2024) · Contemporary Clinical Trials · doi:10.1016/j.cct.2024.107524 · Cited by 2 · see citing works
Self-citationLesion network localization of functional and somatic symptomsPreprint
Milano, B. A., Palm, S. T., Burke, M. J., Drew, W., Kletenik, I., Pines, A. R., Corbetta, M., Grafman, J. H., Downar, J. H., & Siddiqi, S. (2025) · medRxiv · doi:10.1101/2025.03.06.25323494 · Cited by 2 · see citing works
Agger, J. L., Schröder, A., Ørnbøl, E., Jensen, J. S., Pedersen, H. F., Fink, P., & Gormsen, L. K. (2022) · Psychiatry Research · doi:10.1016/j.psychres.2022.114474 · Cited by 1 · see citing works
Self-citationMeasurement Properties of Commonly Used Outcome Measures in Patients With Glenohumeral Instability
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Recall Rate of Opportunistic Screening Mammography in a University Referral Breast Center in Iran
Alikhassi, A., Rahmani, M., Ahmadinejad, N., Kia, S. A., Roozafzai, F., & Habibabadi, Z. A. (2017) · Iranian Red Crescent Medical Journal · doi:10.5812/ircmj.58569
Kallesøe, K. H., Schröder, A., Wicksell, R. K., Preuss, T., Jensen, J. S., & Rask, C. U. (2020) · Figshare · doi:10.6084/m9.figshare.12986608
Self-citationKallesøe, K. H., Schröder, A., Wicksell, R. K., Preuss, T., Jensen, J. S., & Rask, C. U. (2020) · Figshare · doi:10.6084/m9.figshare.12986599
Self-citationKallesøe, K. H., Schröder, A., Wicksell, R. K., Preuss, T., Jensen, J. S., & Rask, C. U. (2020) · Figshare · doi:10.6084/m9.figshare.12986602
Self-citationKallesøe, K. H., Schröder, A., Wicksell, R. K., Preuss, T., Jensen, J. S., & Rask, C. U. (2020) · Figshare · doi:10.6084/m9.figshare.12986605
Self-citationOutcome measures in long COVID clinical trials: a review
van Rhijn-Brouwer, F. C. C.-C., de Canson, C., VanDerNagel, J., Westerhuis, X., Young, S. Y., van Kuijk, S. M. J., de Vries, L. V., van Rhijn, J.-R., & Hellemons, M. E. (2026) · Frontiers in Public Health · doi:10.3389/fpubh.2026.1972605
- Authors
- Schröder, A., Oernboel, E., Licht, R. W., Sharpe, M., & Fink, P.
- Affiliations
- Aarhus University Hospital (DK)
- Royal Edinburgh Hospital (GB)
- Corresponding author
- Schröder, Andreas
- Venue
- Journal of Clinical Epidemiology
- Publisher
- Elsevier BV
- Published
- 2012-01
- Volume
- 65
- Issue
- 1
- Pages
- 30-41
- ISSN
- 0895-4356 (ISSN-L)
- OpenAlex
- W2059783081
- Cited by
- 38
- References
- 72
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 1 · 2023: 1 · 2022: 1 · 2020: 9 · 2019: 2 · 2018: 1 · 2017: 5 · 2016: 2 · 2015: 1 · 2014: 4 · 2013: 3 · 2012: 4
- FWCI
- 8.92
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Clinical Epidemiology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
- Health Sciences › Medicine › Psychiatry and Mental health › Fibromyalgia and Chronic Fatigue Syndrome Research
- Social Sciences › Decision Sciences › Management Science and Operations Research › Psychometric Methodologies and Testing
- Keywords
- functional somatic syndromes, SF-36, construct validity, psychometric validation, fibromyalgia, irritable bowel syndrome, physical component summary, mental component summary, scale correlation, health-related quality of life, outcome measurement
- MeSH terms
- Adult, Algorithms, Female, Fibromyalgia, Health Surveys, Humans, Male, Quality of Life, Surveys and Questionnaires, Research Design, Sampling Studies, Self-Assessment, Severity of Illness Index, Somatoform Disorders, Syndrome, Reproducibility of Results, Randomized Controlled Trials as Topic, Outcome Assessment, Health Care, Sickness Impact Profile, Irritable Bowel Syndrome
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