Correlation between a pollen challenge chamber and a natural allergen exposure study design for eliciting ocular and nasal symptoms: Early evidence supporting a paradigm shift in drug investigation?

2012 ◽  
Vol 130 (1) ◽  
pp. 128-129 ◽  
Author(s):  
Jonathan A. Bernstein
Keyword(s):  
Study Design ◽  
Paradigm Shift ◽  
Allergen Exposure ◽  
Drug Investigation ◽  
Exposure Study ◽  
Nasal Symptoms ◽  
Early Evidence

scholarly journals Summaries of harms in systematic reviews are unreliable (Part 2 of 2): Given the same data sources, systematic reviews of gabapentin have different results for harms

2021 ◽  
Author(s):  
Riaz Qureshi ◽  
Evan Mayo-Wilson ◽  
Thanitsara Rittiphairoj ◽  
Mara McAdams-DeMarco ◽  
Eliseo Guallar ◽  
...  
Keyword(s):  
Study Design ◽  
Systematic Reviews ◽  
Paradigm Shift ◽  
Current Approach ◽  
Numerical Results ◽  
Data Sources ◽  
Covered Area ◽  
High Degree ◽  
Degree Of Overlap

ObjectiveIn this methodologic study (Part 2 of 2), we examined the overlap in sources of evidence and the corresponding results for harms in systematic reviews for gabapentin. Study Design & SettingWe extracted all citations referenced as sources of evidence for harms of gabapentin from 70 systematic reviews, as well as the harms assessed and numerical results. We assessed consistency of harms between pairs of reviews with a high degree of overlap in sources of evidence (>50%) as determined by corrected covered area (CCA). Whereas our focus in this paper is on the results for harms across reviews, Paper 1 examines the methods used to assess harms.ResultsWe found 514 reports cited across 70 included reviews. Most reports (244/514, 48%) were not cited in more than one review. Among 18 pairs of reviews, we found reviews had differences in which harms were assessed and their choice to meta-analyze estimates or present qualitative summaries. When a specific harm was meta-analyzed in a pair of reviews, we found similar effect estimates. ConclusionDifferences in harms results across reviews can occur because the choice of harms is driven by reviewer preferences, rather than standardized approaches to selecting harms for assessment. A paradigm shift is needed in the current approach to synthesizing harms.

Exposure to additives or multigrain flour is associated with high risk of work-related allergic symptoms among bakers

2020 ◽  
pp. oemed-2019-106052
Author(s):  
Mario Olivieri ◽  
Nicola Murgia ◽  
Gianluca Spiteri ◽  
Carlo Alberto Biscardo ◽  
Pierpaolo Marchetti ◽  
...  
Keyword(s):  
High Risk ◽  
Wheat Flour ◽  
Logistic Models ◽  
Allergen Exposure ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Job Tasks ◽  
Work Related ◽  
Nasal Symptoms ◽  
Skin Symptoms

ObjectivesWheat flour exposure in bakers can elicit respiratory and skin symptoms. Scarce data are available on the prevalence of such conditions in bakers. We investigated the prevalence of work-related rhinitis, asthma-like symptoms and dermatitis in bakers according to job task and type of allergens involved.MethodsOf the 229 traditional bakeries in Verona area who were invited to participate in a cross-sectional survey, 211 (92%) accepted; 727 employees in these bakeries answered a modified version of a questionnaire on job tasks; allergen exposure within the bakery; and work-related nasal, asthma-like and skin symptoms during 2010–2014. Determinants of work-related nasal, asthma-like or skin disorders were separately evaluated using different logistic models.ResultsThe prevalence of work-related nasal and asthma-like symptoms was, respectively, 15.1% and 4.2% in bakery shop assistants, increasing to 25.7% and 9.5% in bakers using only wheat flour, and further to 31.8% and 13.6% in bakers using flour and additives, and then to 34.1% and 18.2% in bakers using flour with additives and multigrain (p<0.001). The risk of work-related asthma-like symptoms was more than doubled in bakers using additives without or with multigrain than in shop assistants (OR 2.3, 95% CI 1.0 to 5.5 and OR 3.4, 95% CI 1.1 to 10.8, respectively). Making bread with additives alone or with multigrain significantly increased the risk of work-related nasal symptoms in shop assistants, while the risk of skin symptoms was not significantly affected.ConclusionsBakers using additives alone or with multigrain are at a high risk of experiencing nasal and asthma-like symptoms.

scholarly journals Summaries of harms in systematic reviews are unreliable (Part 1 of 2): Methods used to assess harms are neglected in systematic reviews of gabapentin

2021 ◽  
Author(s):  
Riaz Qureshi ◽  
Evan Mayo-Wilson ◽  
Thanitsara Rittiphairoj ◽  
Mara McAdams-DeMarco ◽  
Eliseo Guallar ◽  
...  
Keyword(s):  
Systematic Review ◽  
Study Design ◽  
Systematic Reviews ◽  
Paradigm Shift ◽  
General Guideline ◽  
Meta Analyses

ObjectiveIn this methodologic study (Part 1 of 2), we examined methods used to assess harms in systematic reviews and meta-analyses (SRMAs) of gabapentin. We compared methods used with current recommendations for synthesizing harms. Study Design &amp; SettingWe followed recommended systematic review practices. We selected reliable SRMAs of gabapentin (i.e., met a pre-defined list of methodological criteria) that assessed at least one harm. We extracted and compared methods in four areas: pre-specification, searching, analysis, and reporting. Whereas our focus in this paper is on the methods used, Part 2 examines the results for harms across reviews. ResultsWe screened 4320 records and identified 157 SRMAs of gabapentin, 70 of which were reliable. Most reliable reviews (51/70; 73%) reported following a general guideline for SRMA conduct or reporting, but none reported following recommendations specifically for synthesizing harms. Across all domains assessed, review methods were designed to address questions of benefit and rarely included the additional methods that are recommended for evaluating harms. ConclusionApproaches to assessing harms in SRMAs we examined are tokenistic and unlikely to produce valid summaries of harms to guide decisions. A paradigm shift is needed. At a minimal, reviewers should describe any limitations to their assessment of harms and provide clearer descriptions of methods for synthesizing harms.

Management of Children with the Trisomy 18 and Trisomy 13 Syndromes: Is there a Shift in the Paradigm of Care?

2021 ◽  
Author(s):  
John C. Carey
Keyword(s):  
Study Design ◽  
Paradigm Shift ◽  
Ventilatory Support ◽  
Trisomy 18 ◽  
Trisomy 13 ◽  
Comfort Care ◽  
Conventional View ◽  
Key Points ◽  
Technological Interventions

Objective The conventional view toward the management of infants with the trisomy 18 and trisomy 13 syndromes has been to recommend pure comfort care and the avoidance of technological interventions. This commentary aims to address the recently raised question about whether there has been a shift in the paradigm of the management of infants with the two conditions. Study Design The study design includes narrative review of the literature. Results A body of opinion pieces and evidence has emerged indicating that there has been a recent increase in the administration of interventions, including ventilatory support and surgery, in the management of children with these syndromes. Conclusion Based on the evidence in the literature, the author concludes that there has been a type of paradigm shift described by philosopher of science, Thomas Kuhn, in the treatment of infants with trisomy 18 and 13. More parents are being offered and choosing technological interventions, including cardiac surgery. Future investigation of the question whether intervention improves outcome, including the quality of life, is crucial in addressing the unanswered questions in this dialogue. Key Points

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