BACKGROUND: In Swedish primary care, the healthcare process for patients with knee osteoarthritis (KOA) can be initiated by a physician or physiotherapist assessment. However, it is unclear how the different assessments affect the healthcare processes and patient reported outcomes over time. The purpose of this study was to examine the differences in health-related quality of life (HrQoL), adjusted for pain and physical function, for patients with KOA when the healthcare process is initiated by a physiotherapist assessment compared to a physician assessment in primary care. METHODS: An assessor-blinded randomised controlled pragmatic trial. Using a computer-generated list of random numbers, patients seeking primary care during 2013 to 2017 with suspected KOA were randomised to either a physiotherapist or physician for primary assessment and treatment. Data was collected before randomisation and at 3, 6, and 12-month follow-ups. Primary outcome was HrQoL using EuroQol 5 dimensions 3 levels questionnaire, index (EQ-5D-3L index) and a visual analogue scale (VAS) (EQ-5D-3L VAS); pain intensity was measured with VAS (0 to 100) and physical function measured with the 30-s chair stand test. Mixed effect model analyses compared repeated measures of HrQoL between groups. The significance level was p < 0.05 and data was applied with intention-to-treat. RESULTS: Patients were randomised to either a physiotherapist (n = 35) or physician (n = 34) for primary assessment. All 69 patients were included in the analyses. There were no significant differences in HrQoL for patients assessed by a physiotherapist or a physician as primary assessor (EQ-5D-3L index, p = 0.18; EQ-5D-3L VAS, p = 0.49). We found that HrQoL changed significantly 12 months after baseline assessment for all patients regardless of assessor (EQ-5D-3L index, p < 0.001; EQ-5D-3 L VAS, p = 0.0049). No adverse events or side effects were reported. CONCLUSIONS: There were no differences in HrQoL, when adjusted for pain and physical function, for patients with KOA when the healthcare process was initiated with physiotherapist assessment compared to physician assessment in primary care. Both assessments resulted in significantly higher HrQoL at the 12-month follow-up. The results imply that physiotherapists and physicians in primary care are equally qualified as primary assessors. TRIAL REGISTRATION: Retrospectively registered at http://ClinicalTrials.gov, ID: NCT03715764.

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