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Conway R.,Galway University Hospitals | Conway R.,National University of Ireland | Conway R.,Park University | Low C.,Connolly Hospital Blanchardstown | And 4 more authors.
BMJ (Online) | Year: 2015

Objective To evaluate the relative risk of pulmonary disease among patients with psoriasis, psoriatic arthritis, and inflammatory bowel disease treated with methotrexate. Data sources PubMed, Cochrane central register of controlled trials, and Embase to 9 January 2014. Study selection Double blind randomised controlled trials of methotrexate versus placebo or active comparator agents in adults with psoriatic arthritis, psoriasis, or inflammatory bowel disease. Studies with fewer than 50 participants or of less than 12 weeks' duration were excluded. Data synthesis Two investigators independently searched both databases. All authors reviewed selected studies. We compared relative risk differences using the Mantel-Haenszel random effects method to assess total respiratory adverse events, infectious respiratory adverse events, non-infectious respiratory adverse events, interstitial lung disease, and death. Results Seven studies met our inclusion criteria, six with placebo as the comparator. Heterogeneity across the studies was not significant (I2=0%), allowing combination of trial results. 504 respiratory adverse events were documented in 1630 participants. Methotrexate was not associated with an increased risk of adverse respiratory events (relative risk 1.03, 95% confidence interval 0.90 to 1.17), respiratory infections (1.02, 0.88 to 1.19), or non-infectious respiratory events (1.07, 0.58 to 1.96). No pulmonary deaths occurred. Conclusions Findings suggested that there was no increased risk of lung disease in methotrexate treated patients with non-malignant inflammatory diseases. Given the limitations of the study, however, we cannot exclude a small but clinically important risk. © BMJ Publishing Group Ltd 2015. Source


Conway R.,Park University | Conway R.,National University of Ireland | Low C.,Connolly Hospital Blanchardstown | Coughlan R.J.,Park University | And 2 more authors.
Journal of Rheumatology | Year: 2016

Objective. To evaluate the relative risk (RR) of pulmonary disease among patients with rheumatoid arthritis (RA) treated with leflunomide (LEF). Methods. We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials to April 15, 2014. We included double-blind randomized controlled trials (RCT) of LEF versus placebo or active comparator agents in adults with RA. Studies with fewer than 50 subjects or shorter than 12 weeks were excluded. Two investigators independently searched both databases. All authors reviewed selected studies. We compared RR differences using the Mantel-Haenszel random-effects method to assess total respiratory adverse events, infectious respiratory adverse events, noninfectious respiratory adverse events, interstitial lung disease, and death. Results. Our literature search returned 5673 results. A total of 8 studies, 4 with placebo comparators, met our inclusion criteria. There were 708 respiratory adverse events documented in 4579 participants. Six cases of pneumonitis occurred, all in the comparator group. Four pulmonary deaths were reported, none in the LEF group. LEF was not associated with an increased risk of total adverse respiratory events (RR 0.99, 95% CI 0.56-1.78) or infectious respiratory adverse events (RR 1.02, 95% CI 0.58-1.82). LEF was associated with a decreased risk of noninfectious respiratory adverse events (RR 0.64, 95% CI 0.41-0.97). Conclusion. Our study found no evidence of increased respiratory adverse events in RCT of LEF treatment. © 2016. All rights reserved. Source


Harrington J.M.,University College Cork | Fitzgerald A.P.,University College Cork | Kearney P.M.,University College Cork | McCarthy V.J.,University College Cork | And 4 more authors.
American journal of hypertension | Year: 2013

BACKGROUND: The Dietary Approaches to Stop Hypertension (DASH) Trial provides critical data on the impact of a specific diet pattern (low in salt, fat, and processed foods and high in fruit and vegetables) on blood pressure (BP). The effect of compliance with a DASH-type diet on BP in a general population sample is less well defined. We studied associations between a DASH style diet and BP.METHODS: We used cross-sectional data from a study of men and women aged 47-73 years (n = 2,047). Participants completed a physical examination that included 3 standardized clinical BP recordings. A subsample (n = 1,187) had ambulatory BP measurements (ABPM) taken. Diet was assessed using a DASH dietary score constructed from a standard Food Frequency Questionnaire. Lower scores indicated less healthy diets. Hypertension was defined as clinic BP ≥ 140/90 mm Hg on medication or as 24-hour ABPM ≥ 130/80 mmHg.RESULTS: Inverse associations were evident between DASH and systolic BP (SBP). There was a difference in clinic SBP of 7.5 mm Hg and 5.1 mm Hg and a difference in ABPM SBP of 6.3mm Hg and 5.4mm Hg in men and women, respectively, between the highest and lowest DASH quintiles. In fully adjusted multivariable regression analysis, DASH score was inversely associated with SBP. Clear population differences in SBP were evident across DASH quintiles.CONCLUSIONS: The observed associations indicate that the findings are consistent with the hypothesis that adherence to DASH-equivalent diet can reduce BP at the population level. Public policy promoting a DASH-style healthy diet could have a significant impact on population health by reducing average BP in the population. © American Journal of Hypertension, Ltd 2013. All rights reserved. For Permissions, please email: journals.permissions@oup.com. Source


You J.J.,McMaster University | Liu Y.,University of Western Ontario | Kirby J.,Connolly Hospital Blanchardstown | Vora P.,McMaster University | Moayyedi P.,McMaster University
Trials | Year: 2015

Background: No head-to-head randomized controlled trials have demonstrated the superiority of one colorectal screening modality over another in reducing colorectal cancer mortality. We conducted a pilot randomized controlled trial of fecal occult blood testing (FOBT), optical colonoscopy (OC), and virtual colonoscopy (VC), to inform the planning of a larger evaluative trial. Methods: Eligible patients (aged 50 to 70) were recruited from five primary care practices in Hamilton, ON, Canada, between March 23, 2010 and August 11, 2010, and randomized 1:1:1 in a parallel design using an automated, centralized telephone service to either FOBT, OC, or VC. To reflect conventional practice, patients received no additional reminders to complete their allocated screening test beyond those received in usual practice. The primary outcome was completion of the assigned screening procedure. Results of the index test and any follow-up investigations were ascertained at 6 months. Participants, caregivers, and outcome assessors were not blinded to group assignment. The trial was stopped early due to lack of ongoing funding. Results: A total of 198 participants were enrolled, of whom 67 were allocated to FOBT, 66 to OC, and 65 to VC. The allocated screening procedure was completed by 43 (64 %) subjects allocated to FOBT (95 % confidence interval [CI], 52-75 %), 53 (80 %) subjects allocated to OC (95 % CI, 69-88 %), and 50 (77 %) subjects allocated to VC (95 % CI, 65-85 %); because the trial stopped early, we had insufficient statistical power to detect clinically relevant differences in completion rates. During 6 months follow-up, colorectal adenomas were detected in 0 (0 %) subjects allocated to FOBT, 12 (18 %) subjects allocated to OC, and 2 (3 %) subjects allocated to VC. One subject in the OC arm had histological evidence of high-grade dysplasia. No subjects were diagnosed with colorectal cancer. Conclusions: In this pilot randomized controlled trial of colorectal cancer screening in a primary care setting, 64-80 % of subjects completed their allocated screening test. These findings may be of value to investigators planning clinical trials to evaluate the effectiveness of colorectal cancer screening. © 2015 You et al. Source


You J.J.,McMaster University | Liu Y.,University of Western Ontario | Kirby J.,Connolly Hospital Blanchardstown | Vora P.,McMaster University | Moayyedi P.,McMaster University
Trials | Year: 2015

Background: No head-to-head randomized controlled trials have demonstrated the superiority of one colorectal screening modality over another in reducing colorectal cancer mortality. We conducted a pilot randomized controlled trial of fecal occult blood testing (FOBT), optical colonoscopy (OC), and virtual colonoscopy (VC), to inform the planning of a larger evaluative trial. Methods: Eligible patients (aged 50 to 70) were recruited from five primary care practices in Hamilton, ON, Canada, between March 23, 2010 and August 11, 2010, and randomized 1:1:1 in a parallel design using an automated, centralized telephone service to either FOBT, OC, or VC. To reflect conventional practice, patients received no additional reminders to complete their allocated screening test beyond those received in usual practice. The primary outcome was completion of the assigned screening procedure. Results of the index test and any follow-up investigations were ascertained at 6 months. Participants, caregivers, and outcome assessors were not blinded to group assignment. The trial was stopped early due to lack of ongoing funding. Results: A total of 198 participants were enrolled, of whom 67 were allocated to FOBT, 66 to OC, and 65 to VC. The allocated screening procedure was completed by 43 (64 %) subjects allocated to FOBT (95 % confidence interval [CI], 52-75 %), 53 (80 %) subjects allocated to OC (95 % CI, 69-88 %), and 50 (77 %) subjects allocated to VC (95 % CI, 65-85 %); because the trial stopped early, we had insufficient statistical power to detect clinically relevant differences in completion rates. During 6 months follow-up, colorectal adenomas were detected in 0 (0 %) subjects allocated to FOBT, 12 (18 %) subjects allocated to OC, and 2 (3 %) subjects allocated to VC. One subject in the OC arm had histological evidence of high-grade dysplasia. No subjects were diagnosed with colorectal cancer. Conclusions: In this pilot randomized controlled trial of colorectal cancer screening in a primary care setting, 64-80 % of subjects completed their allocated screening test. These findings may be of value to investigators planning clinical trials to evaluate the effectiveness of colorectal cancer screening. Trial registration: ClinicalTrials.gov NCT00865527. https://clinicaltrials.gov/ct2/show/NCT00865527. © 2015 You et al. Source

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