Minimal important differences for the WOMAC osteoarthritis index and the Forgotten Joint Score-12 in total knee arthroplasty patients.

BACKGROUND: Total knee arthroplasty (TKA) is an effective treatment for end-stage osteoarthritis. Patient reported-outcome measures (PROMs) capture the patients' perception of the success of an intervention. The minimal important difference (MID) is an important characteristic of the PROM, which helps to interpret results. The aim of this study was to identify the MID for the Forgotten Joint Score-12 (FJS-12) and Western Ontario and McMaster Universities (WOMAC) osteoarthritis index. METHODS: Data were collected in a prospective cohort study. Patients were asked to complete the FJS-12, WOMAC osteoarthritis index and transition items evaluating change over time to determine the MID. We employed an anchor-based methodology relating score change to the response categories of the transition items using both binary logistic regression and receiver operating characteristic (ROC) analysis. RESULTS: Data from 199 patients were analysed. Mean age was 72.3 years, 58% were women. Employing binary logistic regression the MID for the FJS-12 was 10.8 points, for the WOMAC pain score 7.5 points and for the WOMAC function score 7.2 points. ROC analyses found a MID of 13.0 points for the FJS-12, 12.5 points for WOMAC pain and 14.7 points for WOMAC function. CONCLUSION: We report MIDs for the FJS-12 and the WOMAC Pain and Function scales in a TKA patient cohort, which can be used to interpret meaningful differences in score. In line with previous research, we found more advanced statistical methods to result in smaller MID estimates for both scores. TRIAL REGISTRATION: Written consent for this study was obtained from all participants and ethical approval was granted by the local ethics committee (Ethikkommission St. Gallen; EKSG 14/973; Registered 03 July 2014; http://www.sg.ch/home/gesundheit/ethikkommission.html).

Dihydroergotamine nasal spray for the acute treatment of migraine.

We conducted a multicenter, double-blind, parallel-group study to compare the efficacy and safety of dihydroergotamine (DHE) nasal spray and placebo over 4 hours in the treatment of migraine. Of the 112 patients enrolled, 100 were included in the "intent-to-treat" efficacy analysis. The patients self-administered either 2.0 mg DHE (0.5 mg per nostril, repeated after 15 minutes) or placebo at the onset of two separate headaches and rated hourly the drugs' effects on pain severity, pain relief, nausea, and vomiting. The physicians assessed the overall effectiveness of the drugs in relieving headache pain, nausea, and vomiting. Both the patients' and physicians' ratings indicated that DHE was significantly superior to placebo in improving headache and nausea; according to the patients' ratings, these between-group differences were already significant at the first (hour 1) evaluation. There were no significant differential treatment effects with respect to relief of vomiting. Most adverse events were mild or moderate, confined to the nasopharyngeal area, and probably related to the route of administration. We conclude that DHE nasal spray is a safe and effective treatment for the pain and nausea of migraine attacks.

[High-dose immunoglobulin therapy of rheumatoid arthritis]. / Hochdosierte Immunglobulintherapie der rheumatoiden Arthritis.

Eight patients suffering from severe rheumatoid arthritis were treated with high-dose human immunoglobulin. Doses of 500 mg/kg were administered intravenously in the morning on 4 consecutive days. Improvement of arthritic symptoms was indicated by a significant decrease of the Ritchie index, the number of swollen joints, and the duration of morning stiffness as well as an increase of grip strength. The improvement lasted up to 4 months. In 2 patients the disease activity increased again after 4 weeks. Investigations of laboratory parameters demonstrated a significant reduction of the acute-phase response. Parallel investigations of immunological parameters revealed a decrease of Il-6 levels in the sera. Therefore, we suggest a decreased activation status of the monocyte-macrophage system and T cells as a possible mode of action of high-dose immunoglobulin therapy in rheumatoid arthritis.