Abstract

Background: The relationship between autonomic nervous system (ANS) dysfunction and familial Mediterranean fever (FMF) is controversial. We recently reported normal heart rate variability (HRV), suggestive of normal ANS, in patients with uncomplicated FMF.

Objectives: To evaluate ANS function in colchicine non-responders by using the HRV tool.

Methods: The study group comprised 24 FMF patients suffering from recurrent FMF attacks despite treatment with a maximal colchicine dose. Electrocardiogram was measured under strict conditions and HRV parameters were calculated. Results were compared with age- and gender-matched unaffected controls.

Results: No statistically significant difference was found between the groups in any of the HRV parameters: maximal RR, minimal RR and average RR intervals, standard deviation of RR interval, square root of the mean squared differences of successive RR intervals, HRV triangular index, NN50, pNN50, and power spectral analysis parameters.

Conclusions: Although a small difference in HRV parameters in the current study cannot be entirely excluded, FMF patients in whom colchicine did not provide adequate symptomatic relief and who did not develop amyloidosis appear to have normal HRV parameters suggestive of normal ANS function, compared with healthy adults. 

Abstract

Background: The familial Mediterranean fever 50 score (FMF50) score was recently devised to define response to treatment and as an outcome measure for clinical trials of FMF.

Objectives: To examine the performance of the FMF50 score in a previously published trial of rilonacept for patients whose FMF was resistant or intolerant to colchicine.

Methods: We reanalyzed the data from our controlled trial of rilonacept vs. placebo in 14 patients with colchicine-resistant or intolerant FMF using the FMF50 score as the primary outcome. The FMF50 score required improvement by ≥ 50 in five of six criteria (attack frequency, attack duration, global patient assessment, global physician assessment, frequency of attacks with arthritis, and levels of acute-phase reactants without worsening of the sixth criterion).

Results: In the original trial rilonacept was considered effective according to the primary outcome measure (differences in the attack frequency) with eight analyzable patients considered responders and four as non-responders. According to the FMF50 score, only two participants would have been considered responders to rilonacept, and one to placebo. Only two participants had ≥ 50% differences between rilonacept and placebo in five criteria. The major explanation for non-response to treatment was that with rilonacept the duration of attack decreased by ≥ 50% in only 2 participants and 5 participants had no attacks of arthritis either during screening (before randomization) or during treatment with rilonacept.

Conclusions: The proposed FMF50 score did not differentiate well between responders and non-responders compared to the a priori defined primary outcome measure in this successful controlled study. 

Objectives: To estimate the effect of implementation of a safety checklist in an orthopedic surgical department.

Methods: We conducted a single-center cross-sectional study to compare the incidence of complications prior to and following implementation of the Guidelines for Safe Surgery checklist. The medical records of all consecutive adult patients admitted to the orthopedics department at Wolfson Medical Center during the period 1 July 2008 to 1 January 2009 (control group) and from 1 January 2009 to 1 July 2009 (study group) were reviewed. The occurrences of all complications were compared between the two groups.

Results: The records of 760 patients (380 in each group) hospitalized during this 12 month period were analyzed. Postoperative fever occurred in 5.3% vs. 10.6% of patients with and without the checklist respectively (P = 0.008). Significantly more patients received only postoperative prophylactic antibiotics rather than both pre-and postoperative antibiotic treatment prior to implementation of the checklist (3.2% vs. 0%, P = 0.004). In addition, a statistically non-significant 34% decrease in the rate of surgical wound infection was also detected in the checklist group. In a logistic regression model of postoperative fever, the checklist emerged as a significant independent predictor of this outcome: odds ratio 0.53, 95% confidence interval 0.29–0.96, P = 0.037.

Conclusion: A significant reduction in postoperative fever after the implementation of the surgical safety checklist was found. It is possible that the improved usage of preoperative prophylactic antibiotics may explain the reduction in postoperative fever.