Why clinical trial outcomes fail to translate into benefits for patients

Commentary - Open Access - Open Peer Review

• TrialsEmail authorView ORCID ID profil
 

Carl HeneghanEmail authorView ORCID ID profile,

Ben Goldacre and

Kamal R. Mahtani

Trials201718:122https://doi.org/10.1186/s13063-017-1870-2

Open Peer Review reports

Abstract

Clinical research should ultimately improve patient care. For this to be possible, trials must evaluate outcomes that genuinely reflect real-world settings and concerns. However, many trials continue to measure and report outcomes that fall short of this clear requirement. We highlight problems with trial outcomes that make evidence difficult or impossible to interpret and that undermine the translation of research into practice and policy.

Bilastine safety in drivers who need antihistamines: new evidence from high-speed simulator driving test on allergic patients

Eur Rev Med Pharmacol Sci 2018; 22 (3): 820-828

DOI: 10.26355/eurrev_201802_14318

A. Demonte, M.B. Guanti, S. Liberati, A. Biffi, F. Fernando, M. Fainello, P. Pepe

Department of Surgical, Medical, Dental and Morphological Sciences with Interest in Transplant, Oncological and Regenerative Medicine; Dermatology Unit; University of Modena and Reggio Emilia, Modena, Italy. patrizia.pepe@unimore.it

• 
  

OBJECTIVE: Bilastine is a highly selective, non-sedating antihistamine, indicated for the symptomatic treatment of allergic rhinoconjunctivitis and urticaria. Available data suggest that bilastine interferes neither with driving ability nor with flying-related performance. However, no data are available on the effect of bilastine on the driving ability in extreme conditions. Here we analyzed the effect of 7 days treatment with 20 mg bilastine in patients with allergic rhinitis and/or chronic urticaria, on psychophysical performance assessed by the Formula One (F1) high-speed simulator-driving test.

The International Study of the Allergic Rhinitis Survey: outcomes from 4 geographical regions

Asia Pac Allergy. 2018 Jan;8(1):e7. English.  https://doi.org/10.5415/apallergy.2018.8.e7

Desiderio Passali,1 Cemal Cingi,2 Paola Staffa,1 Francesco Passali,3 Nuray Bayar Muluk,4and Maria Luisa Bellussi1

1Department of Otorhinolaryngology - Head and Neck Surgery, University of Siena, 53100 Siena, Italy.

2Department of Otorhinolaryngology - Head and Neck Surgery, Osmangazi University, Faculty of Medicine, 26040 Eskisehir, Turkey.

3ENT Clinic, University of Roma Tor Vergata, 00173 Rome, Italy.

4Department of Otorhinolaryngology - Head and Neck Surgery, Kırıkkale University, Faculty of Medicine, 71450 Kırıkkale, Turkey.

Abstract

Background Allergic rhinitis (AR) is a global health problem and is characterised by one or more symptoms, including sneezing, itching, nasal congestion and rhinorrhea.

Diet during pregnancy and infancy and risk of allergic or autoimmune disease: A systematic review and meta-analysis

PLOS MEDICINE

Vanessa Garcia-Larsen , Despo Ierodiakonou , Katharine Jarrold, Sergio Cunha, Jennifer Chivinge, Zoe Robinson, Natalie Geoghegan, Alisha Ruparelia, Pooja Devani, Marialena Trivella, Jo Leonardi-Bee, Robert J. Boyle 

https://doi.org/10.1371/journal.pmed.1002507

Abstract

Background

There is uncertainty about the influence of diet during pregnancy and infancy on a child’s immune development. We assessed whether variations in maternal or infant diet can influence risk of allergic or autoimmune disease.

Clinical implications of CD4+ T cell subsets in adult atopic asthma patients

• Allergy, Asthma & Clinical Immunology
• Research  Open Access

• Matthew Wiest†,
• Katherine Upchurch†,
• Wenjie Yin,
• Jerome Ellis,
• Yaming Xue,
• Bobby Lanier,
• Mark Millard,
• HyeMee Joo and
• SangKon OhEmail authorView ORCID ID profile

†Contributed equally

Allergy, Asthma & Clinical Immunology201814:7

https://doi.org/10.1186/s13223-018-0231-3

Abstract

Background T cells play a central role in chronic inflammation in asthma. However, the roles of individual subsets of T cells in the pathology of asthma in patients remain to be better understood.

Methods We investigated the potential signatures of T cell subset phenotypes in asthma using fresh whole blood from adult atopic asthma patients (n = 43) and non-asthmatic control subjects (n = 22). We further assessed their potential clinical implications by correlating asthma severity.

The role of tonsillectomy in the Periodic Fever, Aphthous stomatitis, Pharyngitis and cervical Adenitis syndrome; a literature review

BMC Ear, Nose and Throat Disorders

Jostein Førsvoll

 and

Knut Øymar

BMC Ear, Nose and Throat DisordersBMC series – open, inclusive and trusted201818:3

https://doi.org/10.1186/s12901-017-0049-5

©  The Author(s). 2018

Open Peer Review reports

Abstract

Background

Tonsillectomy (TE) or adenotonsillectomy (ATE) may have a beneficial effect on the clinical course in children with the Periodic Fever, Aphthous stomatitis, Pharyngitis and cervical Adenitis (PFAPA) syndrome. However, an immunological reason for this effect remains unknown. This literature review summarizes the current knowledge of the effect of TE or ATE in the PFAPA syndrome.

Dupilumab: an evidence-based review of its potential in the treatment of atopic dermatitis

REVIEW

          

• Abstract
• Metrics
• Get Permission

Authors Eshtiaghi P, Gooderham MJ

Published 23 February 2018 Volume 2018:13 Pages 13—20

DOI https://doi.org/10.2147/CE.S133661

Video abstract presented by Melinda J Gooderham

Views: 3

Panteha Eshtiaghi,¹ Melinda J Gooderham<sup>2–4

1</sup>Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada; ²SKiN Centre for Dermatology, Peterborough, ON, Canada; ³Probity Medical Research, Waterloo, ON, Canada; ⁴Queen’s University, Kingston, ON, Canada

Introduction: Atopic dermatitis (AD) is a recurrent, pruritic inflammatory skin disease with complex immunopathogenesis characterized by a dominant T_H2 response. Dupilumab is an interleukin (IL)-4 receptor alpha antagonist that subsequently blocks IL-4 and IL-13 signaling. It has recently been approved for the treatment of adult patients with moderate-to-severe AD whose current treatment options are limited.

Epinephrine in Anaphylaxis: Preclinical Study of Pharmacokinetics after Sublingual Administration of Taste-Masked Tablets for Potential Pediatric Use

Open Access

Pharmaceutics 2018, 10(1), 24; doi:10.3390/pharmaceutics10010024

Ousama Rachid 1,*, Mutasem Rawas-Qalaji 2,* and Keith J. Simons 3

Abstract

: 

Epinephrine is a life-saving treatment in anaphylaxis. In community settings, a first-aid dose of epinephrine is injected from an auto-injector (EAI). Needle phobia highly contributes to EAI underuse, leading to fatalities—especially in children. A novel rapidly-disintegrating sublingual tablet (RDST) of epinephrine was developed in our laboratory as a potential alternative dosage form.