https://orcid.org/0000-0001-7528-3234
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Abstract
Purpose
To develop a self-administered diagnostic screening questionnaire for lumbar spinal stenosis (LSS) consisting of items with high content validity and to investigate the diagnostic value of the questionnaire and the items.
Patients and Methods
A self-reported diagnostic LSS screening questionnaire was developed based on items from the existing literature describing key symptoms of LSS. The screening questionnaire (index test) was to be tested in a cohort of patients with persistent lumbar and/or leg pain recruited from a Danish publicly funded outpatient secondary care spine clinic with clinicians performing the reference test. However, to avoid unnecessary collection of data if the screening questionnaire proved to be of limited value, a case–control design was incorporated into the cohort design including an interim analysis. Additional cases for the case–control study were recruited at two Danish publicly funded spine surgery departments. Prevalence, sensitivity, specificity and diagnostic odds ratio (OR) were calculated for each individual item, and AUC (area under the curve) was calculated to examine the performance of the full questionnaire.
Results
A 13-item Danish questionnaire was developed and tested in 153 cases and 230 controls. The interim analysis was not in favour of continuing the cohort study, and therefore, only results from the case–control study are reported. There was a positive association for all items except the presence of back pain. However, the association was only moderate with ORs up to 3.3. When testing the performance of the whole questionnaire, an AUC of 0.72 was reached with a specificity of 20% for a fixed sensitivity of 95%.
Conclusion
The items were associated with LSS and therefore have some potential to identify LSS patients. However, the association was not strong enough to provide sufficient accuracy for a diagnostic tool. Additional dimensions of symptoms of LSS need identification to obtain a reliable questionnaire for screening purposes.
Acknowledgments
The authors would like to acknowledge the clinicians who took part in the data collection at the medical department and the surgical department at the Spine Centre of Southern Denmark and at the department of neurosurgery, Odense University Hospital.
Abbreviations
AUC, area under the curve; CI, confidence Interval; LSS, lumbar spinal stenosis; MRI, magnetic resonance imaging; NRS, numerical rating scale; ODI, Oswestry Disability Index.
Data Sharing Statement
The data supporting the findings of this study are retained at a central repository at the Spine Centre of Southern Denmark, Middelfart, Denmark and restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. However, data used in the current study can be applied for by contacting the Spine Centre of Southern Denmark.
Additional file 1 provides an overview of the 41 relevant questions extracted from five papers and how they were merged into the final 13 questions.
Ethics Approval and Informed Consent
The Regional Scientific Ethics Committee for Southern Denmark states on their webpage that this type of study did not require ethical approval.Citation28 The study conformed to the standards set by the Declaration of Helsinki. The project included only legally competent, consenting patients, and participation was voluntary. All participants were informed about the purpose of the study and written consent was collected. The project was registered at Danish Data Protection Agency [no: 10.180].
Author Contributions
RKJ: Study design, data acquisition, drafting the article, interpretation of data. HHL: Study design, statistical analysis, interpretation of data, revision of the article. ADKA: study design, data acquisition, revision of the article. RMM: Data acquisition, revision of the article. BSC: Data acquisition, revision of the article. WV: Study design, drafting the article, statistical analysis, interpretation of data. In addition, all authors contributed to data analysis, drafting or revising the article, have agreed on the journal to which the article will be submitted, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.
Disclosure
The authors declare that they have no competing interests for this work.