Peripheral neuropathies in rheumatic diseases: More diverse and frequent than expected. A cross-sectional study.

BACKGROUND/OBJECTIVE: Peripheral neuropathies (PN) are heterogeneous nerve disorders; frequently rheumatic patients have neuropathic symptoms. In some rheumatic diseases (RD) PN are secondary to nerve compression while others are related to metabolic abnormalities, inflammation or vasculitis. Our aim was to explore the frequency of neuropathic symptoms with three neuropathy questionnaires (NQ) and nerve conduction studies (NCS) in RD. METHODS: This is a cross-sectional study in patients with any RD attending for the first time to a rheumatology outpatient clinic. We included all patients who accepted to participate and who answered three NQ and received a physical evaluation. Twenty patients were randomly selected to perform NCS and 10 healthy subjects were included as controls. The topographic diagnoses were: mononeuropathy, multiplex mononeuropathy, and/or polyneuropathy. STATISTICAL ANALYSIS: descriptive statistics (mean, median, standard deviation, interquartile range and frequency, odds ratios and Pearson correlation test). RESULTS: One hundred patients and 10 healthy subjects were included. Sixty-nine were female, mean age 40.6 ± 15.7 years. Rheumatic diagnoses were: systemic lupus erythematosus (26%), rheumatoid arthritis (16%), gout (14%), and osteoarthritis (11%). Fifty-two patients had neuropathic signs during physical examination and 67% had positive questionnaires with variable scores among several RD. Abnormal NCS was reported in 14 patients (70%): 6 (42.8%) median nerve mononeuropathies, 4 (28.5%) multiplex mononeuropathies and 4 (28.5%) polyneuropathies. None of the healthy subjects had neuropathy (NQ, physical evaluation, or NCS). Risk of being NCS positive is higher when the patients were NQ positive. CONCLUSION: PN has variable distribution and high frequency in patients with RD; NQ+ increases the risk of presenting NCS+ for PN.

Trends of Informed Consent forms for industry-sponsored clinical trials in rheumatology over a 17-year period: Readability, and assessment of patients' health literacy and perceptions.

OBJECTIVE: To assess trends in the length and readability of informed consent forms (ICFs) for industry-sponsored multinational clinical trials (RCTs) in rheumatology over a 17-year period. Additionally, to assess the health literacy (HL) and perceptions of ICFs among participants of current RCTs. METHODS: The readability of ICFs conducted at an outpatient rheumatology clinic between 1999 and 2016 were assessed using the INFLESZ scale. Patients' HL was assessed using SALHSA-50 and STOFHLA. Patient opinions were assessed using a self-reported, in-office questionnaire with an independent patient sample who had signed an ICF in the past 6 months. RESULTS: Thirty-nine ICFs about 22 drugs from 13 pharmaceutical companies were analyzed. The global mean readability was 57 ± 3 (95% CI: 56-58), and all ICFs were categorized as either "somewhat difficult to read" or "average." Readability remained at these levels without significant changes from 1999 to 2016. The mean length of the ICFs written between 1999 and 2005 was 13 ± 5 pages, with a significant increase thereafter (mean 22 ± 8 pages, p = 0.004). Depending on the instrument, of 95 patients participating in the HL assessment, between 18% and 44% had limited HL. Of 90 patients participating in the perceptions questionnaire, 84% reported understanding the ICF well. However, 2-57% misunderstood basic concepts, including the study drug name and placebo. CONCLUSIONS: The disparity between the readability of ICFs with patients' HL and their comprehension of ICFs continues, even after decades of attempts of regulatory agencies and numerous published suggestions.