Scleroderma treatment differs between experts and general rheumatologists.
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Comorbidity↗
Biomedical subjects
Janine M Ouimet
Publications and source records attributed to Janine M Ouimet.
Close association of herpes zoster reactivation and systemic lupus erythematosus (SLE) diagnosis: case-control study of patients with SLE or noninflammatory musculoskeletal disorders.
OBJECTIVE: To investigate the prevalence of infections, particularly the frequency of shingles and the timing of varicella zoster virus (VZV) reactivation, and antibiotic use, vaccinations, and joint trauma prior to and at diagnosis of systemic lupus erythematosus (SLE). METHODS: We sent questionnaires to patients with SLE (n = 93) and controls with noninflammatory musculoskeletal disorders (MSK; n = 353) including osteoarthritis, fibromyalgia, and tendonitis. We matched SLE patients to controls for sex (up to 1:3). RESULTS: The response rate in SLE was 66% and in controls 69% (p < 0.53). Four of 61 SLE patients and 12 of 173 controls were men. The mean disease duration in the SLE group was 8 +/- 1 years compared to 10 +/- 1 years in controls (p < 0.23). SLE patients were significantly younger than controls (mean age of SLE patients 49 +/- 2 vs 57 +/- 1 years for controls; p < 0.0004), and results were adjusted for age. A significantly higher proportion of SLE participants had a history of VZV (shingles) (19% vs 7%, respectively; OR 2.98, p < 0.003), whereas rubella was reported less in SLE (23% vs 42%; OR 0.43, p < 0.03). VZV infections were clustered just prior to or after diagnosis in SLE but were more widely spaced temporally in the controls (1 +/- 4.5 years after the diagnosis of SLE vs -14.7 +/- 4 years before the diagnosis of noninflammatory MSK disorder; p < 0.003). Diagnosis of shingles was observed in 6 of 11 SLE patients within +/- 2 years of SLE diagnosis, whereas only 2 of 15 controls had shingles within +/- 2 years of diagnosis (OR 7.2, p < 0.03). Only 2 patients with SLE were taking immunosuppressive drugs or steroids at time of shingles, so immunosuppressive therapy was not usually concomitant at time of VZV reactivation. Common infections (respiratory, urinary tract, ear, and eye) in the SLE group exceeded controls, but not significantly (23% vs 9%; OR 2.98, p < 0.06) and SLE patients were more likely to have been vaccinated since 18 years of age with any type of vaccine (69% vs 51%; OR 2.21, p < 0.04). SLE patients were less likely than controls to report joint trauma within one year prior to their diagnosis (25% vs 40%; OR 0.49, p < 0.04). There were no differences with respect to streptococcal throat infection (p < 0.96), diarrhea/vomiting (p < 0.84), rash with fever (p < 0.07), parvovirus infection (p < 0.16), infection after surgery (p < 0.58), respiratory tract infection (p < 0.71), or ear (p < 0.09) and eye infection (p < 0.68) one year prior to diagnosis. A higher proportion of SLE patients had a history of urinary tract infections (46% vs 25%), but this was not significant (p < 0.17), nor was it significant one year prior to diagnosis (p < 0.63). Overall, the likelihood of having any infection one year prior to diagnosis was not significantly higher in the SLE group (p < 0.56). There were no differences one year prior to diagnosis in travel history (p < 0.69), hospitalizations (p < 0.47), use of antibiotics (p < 0.54), history of rheumatic fever, positive TB skin test, or hepatitis A, B or C infection. CONCLUSION: Varicella reactivation as shingles is increased in patients with SLE and clusters around diagnosis. Vaccinations are increased in those with SLE compared to controls. Common infections are not significantly increased in SLE patients prior to onset of symptoms. We cannot determine if VZV infections are causally associated with SLE in some people, are from an abnormal immune system response due to the lupus itself or from the use of steroids or other immunosuppressive drugs to control the disease, or are spurious.
Case-Control Studies↗
Erectile dysfunction associated with scleroderma: a case-control study of men with scleroderma and rheumatoid arthritis.
OBJECTIVE: To determine if men with systemic sclerosis (SSc) are at increased risk of developing erectile dysfunction (ED) compared to men with rheumatoid arthritis (RA), and to investigate the temporal relationship of ED related to rheumatologic disease. METHODS: Men with SSc identified from the practices of 2 rheumatologists were age matched to men with RA and were sent a standardized, validated questionnaire (SHIM IIEF-5) to assess ED and related factors. The questionnaire also addressed information on the subject's overall health and rheumatic disease status. RESULTS: The response rate was 50% (48% in SSc and 55% in RA), thus 43 with SSc and 23 with RA were included. The mean age of respondents was 53 yrs +/- 1.34 (SEM), (range 34 to 83). No statistical differences were found for marital status, alcohol or drug use, or past/present smoking. Men with scleroderma weighed less than men with RA (p < 0.004) and were more likely to have Raynaud's phenomenon (p < 0.0001), and to have fewer biological children (2.0 +/- 0.2 vs 2.7 +/- 0.2, p < 0.01). The prevalence of erectile dysfunction was 81% (SSc) and 48% (RA), (relative risk for SSc vs RA: 4.77; 95% CI: 1.55, 14.66; p < 0.005). In subjects who had ED, 78% (both SSc and RA) reported it occurring after disease onset. Men with SSc noted their ED began 2.7 +/- 1.2 (mean +/- SEM) years after their disease was diagnosed, and similarly, men with RA noted their ED began 3.3 +/- 2.2 years after disease diagnosis, p = 0.82. Eighty-six percent of patients with SSc had Raynaud's phenomenon (RP) compared to 19% RA, p < 0.0001. Eighty percent of subjects with RP (SSc + RA) had ED versus 50% of men without RP, p < 0.01. In RA subjects with RP (n = 4), 75% had experienced ED, versus 39% of RA without RP, p = 0.18. Possible confounding factors for ED were examined including smoking, hypertension, diabetes, and steroid use; all except self-reported history of nerve damage (p < 0.0005) and diabetes (p < 0.02) were insignificant for predicting the likelihood of increased ED. Patients with SSc were not more likely than RA to have experienced nerve damage (p = 0.25), or diabetes (p = 0.19). CONCLUSION: ED occurs frequently in SSc, is more common than in RA, and occurs on average 3 years after disease onset. RP appears to be associated with ED in both SSc and RA, but is not necessarily an independent risk factor for ED in SSc alone.
Adult↗
Are subjects satisfied with the informed consent process? A survey of research participants.
OBJECTIVE: Letters of information (LOI) for clinical trials are becoming longer and more complicated. We investigated patients' perspectives of their ability to understand the information presented during a clinical trial. Satisfaction with and motivation for participation in clinical trials were also ascertained. Perceptions from various treatment disciplines were compared. METHODS: Participants were chosen from 14 clinical trials (departments of rheumatology, ophthalmology, and cardiology) conducted at the same university. Subjects were asked to complete a written questionnaire that assessed demographic information, recall and understanding of information, subjects' decisions to participate, and perceptions/opinions of the study. The response rate was 75% (rheumatology, n = 74; ophthalmology, n = 32; cardiology, n = 84). RESULTS: The majority of respondents (98%) indicated that they were satisfied with the informed consent process and with their involvement in a trial (97%). Subjects who reported having understood the LOI had better recall of placebo/active drug comparator (p < 0.03), and better understanding of why placebo was used (p < 0.04). No differences were found between those who reported understanding and those who did not on understanding the concept of concealed allocation (blinding). Subjects who felt they had received "the right amount of information" were more likely not to understand concealed allocation. The most frequent reason for trial participation was to help medical science (80%). Subjects with higher education were more likely to understand the reason for placebo use (p < 0.0003), but were not more likely to understand concealed allocation (p < 0.08). CONCLUSION: Subjects reported that they were satisfied with the informed consent process and their experience in a clinical trial, and that they understood trial concepts. Subjects may be able to self-assess their own level of understanding for trial concepts that intrinsically make sense within the context of their beliefs about medical care, but other trial concepts may be misunderstood/misinterpreted regardless of self-assessment of understanding or education level (i.e., concealed allocation). Subjects may prefer to believe that investigators know which treatment they are receiving, and have made a good treatment decision specific to their case, despite having being told about concealed allocation and placebo use.
Adult↗