Does MRI add value in general practice for patients with traumatic knee complaints? A 1-year randomised controlled trial.

OBJECTIVE: To determine whether referral to MRI by the general practitioner (GP) is non-inferior to usual care (no access to MRI by GPs) in patients with traumatic knee complaints regarding knee-related daily function. METHODS: This was a multicentre, non-inferiority randomised controlled trial with 1-year follow-up. GPs invited eligible patients during or after their consultation. Eligible patients (18-45 years) consulted a GP with knee complaints due to a trauma during the previous 6 months. Patients allocated to the MRI group received an MRI at (median) 7 (IQR 1-33) days after the baseline questionnaire. Patients in the usual care group received information on the course of knee complaints, and a referral to a physiotherapist or orthopaedic surgeon when indicated. The primary outcome measure was knee-related daily function measured with the Lysholm scale (0 to 100; 100=excellent function) over 1 year, with a non-inferiority margin of 6 points. RESULTS: A total of 356 patients were included and randomised to MRI (n=179) or usual care (n=177) from November 2012 to December 2015. MRI was non-inferior to usual care concerning knee-related daily function during 1-year follow-up, for the intention-to-treat (overall adjusted estimate: 0.33; 95% CI -1.73 to 2.39) and per-protocol (overall adjusted estimate: 0.06; 95% CI -2.08 to 2.19) analysis. There were no differences between both groups in the amount of patients visiting other healthcare providers. CONCLUSION: MRI in general practice in patients with traumatic knee complaints was non-inferior to usual care regarding knee-related daily function during 1-year follow-up. TRIAL REGISTRATION NUMBER: NTR3689.

Post-traumatic knee MRI findings and associations with patient, trauma, and clinical characteristics: a subgroup analysis in primary care in the Netherlands.

BACKGROUND: The added value of magnetic resonance imaging (MRI) in primary care is still being debated. A high diagnostic yield can be expected in young and active patients with post-traumatic knee complaints. AIM: To determine the frequency of MRI abnormalities in young and active patients (aged 18-45 years) and the associations with patient, trauma, and clinical characteristics. DESIGN AND SETTING: A subgroup analysis of 174 patients, aged 18-45 years with knee trauma of <6 months, allocated to MRI in a randomised controlled trial on the yield of MRI in primary care. Patients were recruited by 150 GPs in the Netherlands from October 2012 to November 2015. METHOD: Associations were expressed using mean differences, odds ratio (OR) and predictive values. RESULTS: Sixty-seven out of 174 patients (39%) had a positive MRI finding, predominantly anterior cruciate ligament (ACL) ruptures (22%) and/or traumatic meniscal tears (15%). Patients with a pre-existing musculoskeletal comorbidity had a two-fold lower prevalence of positive MRI findings (21%), OR 3.0 (95% confidence interval [CI] = 1.3 to 7.0). A 'sports related trauma' showed the highest OR of 4.6 (95% CI = 2.2 to 9.3) for a positive MRI finding. Clinical scores were statistically, significantly worse in patients with positive MRI findings, with mean differences ranging from 10 to 20%. Furthermore, increasing duration of complaints was correlated with decreasing prevalence rates of positive MRI findings. Overall, a popping sound and direct swelling showed the highest positive predictive value of 65% for the presence of positive MRI findings. CONCLUSION: The results from this study enable a preselection of patients to increase the diagnostic yield of MRI in primary care.

Discontinuation of a randomised controlled trial in general practice due to unsuccessful patient recruitment.

BACKGROUND: A randomised controlled trial (RCT) in general practice, recruiting incident patients with (sub)acute sciatica, was discontinued because of insufficient recruitment. AIM: To describe factors that influenced the recruitment process and ultimately led to discontinuation of this trial, and to enable others to learn from this experience. DESIGN & SETTING: A pragmatic RCT was designed to compare two pain medication prescription strategies for treatment of (sub)acute sciatica in general practice. After 1 year of patient recruitment, the trial was prematurely terminated. METHOD: To analyse the underperforming recruitment, patient information systems of 20 general practices were screened twice a month to search for eligible patients and identify reasons for non-eligibility. Secondly, after study termination, an open question was distributed to the participating GPs for their views on the recruitment process. RESULTS: A total of 116 GPs from 37 general practices collaborated in the trial. Only eight of 234 patients were included after 12 months. The 22 GPs who offered their opinion on the main reasons for unsuccessful recruitment considered that these were the low incidence rate and strict eligibility criteria, a strong patient and/or GP preference, and time constraints. CONCLUSION: For this RCT, multiple factors were related to recruitment problems but it remains unknown which determinants prevailed. As the research question is unanswered but remains relevant, it is recommended that GPs' daily practice is taken into account when designing an RCT, a pilot study should be performed for feasibility of recruitment, and GP assistants should be involved at an early stage.