Inter-rater Reliability of Diagnosing Thoracic Outlet Syndrome by NHS Physiotherapists Using the CORE-TOS Clinical Diagnostic Criteria

The principal method of the study will involve retrospective analysis of data prospectively recorded in patients' clinical notes. The data will pertain to clinical information recorded by both the physiotherapist referring the patient, and the principal investigator (P.I.) at their initial assessment of the patient. Patients will be selected from within the specific timeframe of the calendar year between April 2021 and April 2022.

At the first appointment with each rater patients will have undergone subjective and objective clinical examination within the current scope of physiotherapy practice. All relevant clinical CORE-TOS clinical diagnostic criteria (CDC) noted by each on examination will have been recorded, up to a maximum of 5.

Data Collection:

Pending ethical clearance from Queen Margaret University Edinburgh, collation and analysis of the data will take place in April & May 2022 (i.e., one calendar year following the final education session). Within the allocated resources of the study all data collection and analysis will be undertaken by the P.I. only and thus no blinding will be possible. A retrospective review of the P.I.s patient files will be undertaken to collate the relevant patient files. These are hand-written, paper files stored locally within the target physiotherapy department. An Excel® (Microsoft®) spreadsheet will be used to generate a database for the study. This will be stored on the local health service, password-protected server behind the researcher's unique login. Patients will be anonymised on the worklist to a random number using the random number generator function in Excel® and this number written into their case notes, along with the protocol identifier and the date the case note was reviewed. The purpose of this will be twofold. The first of these is for local data protection requirements. The second is to allow for any future consistency checking of the data, given that no blinding of the results will be possible within the study design.

Each CORE-TOS CDC noted by both the referrer (rater 1) and the principal investigator (rater 2) will be recorded on an Excel® spreadsheet. The worksheet will allow for both future quantification of CDC out of a possible 5 and to assist identification of any consistent errors or omissions. For the purposes of descriptive analysis, supplementary data will also be collected all of which will be personally non-identifiable in keeping with ethical and data protection agreements. These will include age, sex, initial quickDASH and SF-12 scores, the length of time symptoms were present prior to review by the researcher, the presence/absence of antecedent trauma, previous imaging and any other clinical sub-specialities seen for this presentation. Given the inability to blind the study, this Excel® file will be stored securely on the local NHS server, behind the researcher's password-protected login for 12 months to aid consistency checking, if required. In addition, it will also be used to inform an intended future study on the outcomes of local treatment for TOS and the optimal pathway for management of it.