Inequity in smoking cessation clinical trials testing pharmacotherapies: exclusion of smokers with mental health disorders

ObjectivesPeople suffering from mental health disorder (MHDs) are often under-represented in clinical research though the reasons for their exclusion are rarely recorded. As they have higher rates of smoking and nicotine dependence, it is crucial that they are adequately represented in clinical trials of established pharmacotherapy interventions for smoking cessation. This review aims to examine the practice of excluding smokers with MHDs and reasons for such exclusion in clinical trials evaluating pharmacotherapy treatments for smoking cessation.Data sourceThe Cochrane database of systematic reviews was searched until September 2020 for reviews on smoking cessation using pharmacotherapies.Study selectionRandomised controlled trials (RCTs) within the selected Cochrane reviews were included.Data extractionConducted by one author and independently verified by three authors.Data synthesisWe included 279 RCTs from 13 Cochrane reviews. Of all studies, 51 (18.3%) explicitly excluded participants with any MHDs, 152 (54.5%) conditionally excluded based on certain MHD criteria and 76 (27.2%) provided insufficient information to ascertain either inclusion or exclusion. Studies of antidepressant medications used for smoking cessation were found to be 3.33 times more likely (95% CI 1.38 to 8.01, p=0.007) to conditionally exclude smokers with MHDs than explicitly exclude compared with studies of nicotine replacement therapy.ConclusionSmokers with MHDs are not sufficiently represented in RCTs examining the safety and effectiveness of smoking cessation medications. Greater access to clinical trial participation needs to be facilitated for this group to better address access to appropriate pharmacotherapeutic interventions in this vulnerable population.

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Rationalisations for women-only randomised controlled trials in conditions that affect both sexes: a scoping review protocol

BMJ Open ◽

10.1136/bmjopen-2020-043370 ◽

2021 ◽

Vol 11 (2) ◽

pp. e043370

Author(s):

Ainsley Matthewson ◽

Olena Bereznyakova ◽

Brian Dewar ◽

Alexandra Davis ◽

Mark Fedyk ◽

...

Keyword(s):

Clinical Trials ◽

Scoping Review ◽

Randomised Controlled Trials ◽

Standard Of Care ◽

Standards Of Care ◽

Controlled Trials ◽

Theory Approach ◽

Reference Centre ◽

Cochrane Database ◽

Randomised Controlled

IntroductionWomen have historically been under-represented in randomised controlled trials (RCTs), including many landmark RCTs that established standards of care. In light of this fact, some modern researchers are calling for replication of earlier landmark trials with women only. This approach is ethically concerning, in that it would require some enrolled women to be deprived of treatments that are currently considered standard of care.ObjectiveIn an attempt to better understand the justification of a women-only approach to designing clinical trials, this study looks to systematically categorise the number of women-only RCTs for conditions that affect both men and women and the reasons given within the medical and philosophical literatures to perform them.MethodologyThis scoping review of the literature will search, screen and select articles based on predetermined inclusion/exclusion criteria, after which a grounded theory approach will be used to synthesise the data. It is expected that there will be a variety of reasons given for why a women-only trial may be justified. Electronic databases that will be searched include MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Clinical Trials Register, Web of Science Proceedings, ClinicalTrials.gov, Philosopher’s Index, Phil Papers, JSTOR, Periodicals Archive Online, Project MUSE and the National Reference Centre for Bioethics.SignificanceThe scope of this study is to determine published rationales used to justify women-only randomised trials, both in the case of new trials and in the repetition of landmark trials.Ethics and disseminationResearch ethics board approval is not required for this study as there is no participant involvement. Results will be published as a stand-alone manuscript and will inform a larger project related to the ethics of a women-only RCT of carotid intervention for women with symptomatic high-grade carotid stenosis.

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Role of Topical Oxymetazoline for Management of Erythematotelangiectatic Rosacea

Annals of Pharmacotherapy ◽

10.1177/1060028017740139 ◽

2017 ◽

Vol 52 (3) ◽

pp. 263-267 ◽

Cited By ~ 5

Author(s):

Rebecca M. Hoover ◽

John Erramouspe

Keyword(s):

English Language ◽

Human Subjects ◽

Data Extraction ◽

Drug Approval ◽

Current Data ◽

Patient Response ◽

Study Selection ◽

Cochrane Database ◽

Drug Approval Process ◽

Individual Patient Response

Objective: To review and summarize topical oxymetazoline’s pharmacology, pharmacokinetics, efficacy, safety, cost, and place in therapy for persistent redness associated with erythematotelangiectatic rosacea. Data Sources: Literature searches of MEDLINE (1975 to September 2017), International Pharmaceutical Abstracts (1975 to September 2017), and Cochrane Database (publications through September 2017) using the terms rosacea, persistent redness, α -agonist, and oxymetazoline. Study Selection and Data Extraction: Results were limited to studies of human subjects, English-language publications, and topical use of oxymetazoline. Relevant materials from government sources, industry, and reviews were also included. Data Synthesis: Data support the efficacy of oxymetazoline for persistent facial redness. Little study beyond clinical trials cited in the drug approval process has been conducted. Current data suggest that oxymetazoline is similar in safety and efficacy to brimonidine. Head-to-head comparisons of topical α-agonists for erythema caused by rosacea are needed. Conclusion: The topical α-agonist, oxymetazoline, is safe and effective for reducing persistent facial redness associated with erythematotelangiectatic subtype of rosacea. Health care practitioners selecting among treatments should consider not only the subtype of rosacea but also individual patient response, preference, and cost.

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A novel ACT-based video game to support mental health through embedded learning: a mixed-methods feasibility study protocol

BMJ Open ◽

10.1136/bmjopen-2020-041667 ◽

2020 ◽

Vol 10 (11) ◽

pp. e041667

Author(s):

Darren J Edwards ◽

Andrew H Kemp

Keyword(s):

Mental Health ◽

Mixed Methods ◽

Video Game ◽

Emotional Regulation ◽

Cognitive Skills ◽

Controlled Trial ◽

Qualitative Interviews ◽

Mental Health Disorder ◽

Acceptance And Commitment ◽

Randomised Controlled

IntroductionIn recent years, serious video games have been used to promote emotional regulation in individuals with mental health issues. Although these therapeutic strategies are innovative, they are limited with respect to scope of treatment, often focusing on specific cognitive skills, to help remediate a specific mental health disorder.ObjectiveHere, we propose a protocol for assessing the feasibility of a novel acceptance and commitment therapy (ACT)-based video game for young adults.Methods and analysisThe Medical Research Council (MRC) framework will be used for developing a complex intervention to design and test the feasibility of an ACT-based video game intervention using a mixed-methods approach involving qualitative and quantitative data. The primary outcomes will include feasibility testing of recruitment processes and the acceptability of the intervention through qualitative interviews, attendance and rates of attrition. Secondary outcomes will involve a series of quantitative questionnaires to obtain effect sizes for power analysis, allowing for the ideal sample size for an appropriately powered, randomised controlled trial to be determined.Ethics and disseminationThis study has been approved by the Psychology Department Research Ethics Committee (2020-4929-3923) at Swansea University in the UK. Dissemination activities will involve publications in peer-reviewed journals, presentations at local and national conferences and promotion through social media.Trial registration numberNCT04566042.

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Thromboembolic events, recurrent bleeding and mortality after resuming anticoagulant following gastrointestinal bleeding

Thrombosis and Haemostasis ◽

10.1160/th15-01-0063 ◽

2015 ◽

Vol 114 (10) ◽

pp. 819-825 ◽

Cited By ~ 44

Author(s):

Chatree Chai-Adisaksopha ◽

Christopher Hillis ◽

Manuel Monreal ◽

Daniel Witt ◽

Mark Crowther

Keyword(s):

Data Extraction ◽

Meta Analysis ◽

Anticoagulation Therapy ◽

Phase Iii ◽

Recurrent Bleeding ◽

Thromboembolic Events ◽

Gi Bleeding ◽

Study Selection ◽

Language Restriction ◽

Randomised Controlled

SummaryGastrointestinal (GI) bleeding commonly complicates anticoagulant therapy. We aimed to systematically review the published literature to determine the risk of thromboembolism, recurrent GI bleeding and mortality for patients on long-term anticoagulation who experience GI bleeding based on whether anticoagulation therapy was resumed. We performed a systematic review of phase III randomised controlled trials and cohort studies in patients with atrial fibrillation or venous thromboembolism who received oral anticoagulant. We searched MEDLINE, EMBASE and CENTRAL (from 1996-July 2014), conferences abstracts (from January 2006-July 2014) and www.clinicaltrials.gov (up to the last week of July 2014) with no language restriction. Two reviewers independently performed study selection, data extraction and study quality assessment. A total of three studies were included in the meta-analysis. The resumption of warfarin was associated with a significant reduction in thromboembolic events (hazard ratio [HR] 0.68, 95 % confidence interval [CI] 0.52 to 0.88, p < 0.004, I2=82 %). There was an increase in recurrent GI bleeding but not statistically significant for patients who restarted warfarin compared to those who did not (HR 1.20, 95 % CI 0.97 to 1.48, p = 0.10, I2 = 0 %). Resumption of warfarin was associated with significant reduction in mortality (HR 0.76, 95 % CI 0.66 to 0.88, p < 0.001, I2 = 87 %). This meta-analysis demonstrates that resumption of warfarin following interruption due to GI bleeding is associated with a reduction in thromboembolic events and mortality without a statistically significant increase in recurrent GI bleeding.Institution where the work was performed: McMaster University, Hamilton, Ontario, Canada.

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Acupuncture for Tourette Syndrome: A Systematic Review

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2016/1834646 ◽

2016 ◽

Vol 2016 ◽

pp. 1-10 ◽

Cited By ~ 6

Author(s):

Jinna Yu ◽

Yongming Ye ◽

Jun Liu ◽

Yang Wang ◽

Weina Peng ◽

...

Keyword(s):

Tourette Syndrome ◽

Western Medicine ◽

Data Extraction ◽

Cochrane Collaboration ◽

Fixed Effect Model ◽

Study Selection ◽

Mean Differences ◽

Randomised Controlled ◽

Meta Analyses ◽

The Cochrane Collaboration

Tourette syndrome (TS) is a neuropsychiatric disorder that affects both children and adults. We searched for randomised controlled trials (RCTs) using acupuncture to treat TS written in English or Chinese without restrictions on publication status. Study selection, data extraction, and assessment of study quality were conducted independently by two reviewers. Meta-analyses were performed using Review Manager (RevMan) 5.3 software from the Cochrane Collaboration. Data were combined with the fixed-effect model based on a heterogeneity test. Results were presented as risk ratios for dichotomous data and mean differences (MDs) for continuous data. This review included 7 RCTs with a total of 564 participants. The combined results showed that acupuncture may have better short-term effect than Western medicine for TS and that acupuncture may be an effective adjuvant therapy in improving the effect of Western medicine on TS, but the evidence is limited because of existing biases. Rigorous high-quality RCTs are needed to verify these findings.

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Effects of Composite Attachments on Orthodontic Clear Aligners Therapy: A Systematic Review

Materials ◽

10.3390/ma15020533 ◽

2022 ◽

Vol 15 (2) ◽

pp. 533

Author(s):

Riccardo Nucera ◽

Carolina Dolci ◽

Angela Mirea Bellocchio ◽

Stefania Costa ◽

Serena Barbera ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Data Extraction ◽

Risk Of Bias ◽

Bias Assessment ◽

Bodily Movement ◽

Study Selection ◽

Medium Risk ◽

Clear Aligner ◽

Anterior Root

This systematic review aims to highlight the differences between different clear aligner therapies that differ in the presence of attachments or in attachment configuration. Eight electronic databases were searched up to March 2020. Two authors independently proceeded to study selection, data extraction, and risk of bias assessment. The analysis of the results was carried out examining six groups of movements (mesio-distal tipping/bodily movement; anterior bucco-lingual tipping/root torque; posterior bucco-lingual tipping/expansion; intrusion; extrusion; rotation). Five clinical trials were selected and all of them showed a medium risk of bias. Literature showed that attachments mostly increase the effectiveness of orthodontic treatment with clear aligners, improving anterior root torque, rotation, and mesio-distal (M-D) movement; they are also important to increase posterior anchorage. However, some articles showed contradictory or not statistically significant results. Attachments also seem to improve intrusion, but the evidence about this movement, as well as extrusion, is lacking. No studies evaluated posterior bucco-lingual tipping/expansion. Further clinical trials are strongly suggested to clarify the influence of attachments and their number, size, shape, and position on each orthodontic movement.

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Lactulose in the Management of Constipation: A Current Review

Annals of Pharmacotherapy ◽

10.1177/106002809202601017 ◽

1992 ◽

Vol 26 (10) ◽

pp. 1277-1282 ◽

Cited By ~ 19

Author(s):

Theresa V. Kot ◽

Ngaire A. Pettit-Young

Keyword(s):

Clinical Trials ◽

Adverse Effects ◽

Clinical Studies ◽

Data Extraction ◽

Point Of View ◽

Data Synthesis ◽

Study Selection ◽

Beneficial Response ◽

A Current

OBJECTIVE: To review the current published clinical studies evaluating the clinical efficacy and safety of lactulose compared with other laxatives or placebo. Adverse effects associated with lactulose are also reported. DATA SOURCES: Information was retrieved by searching the MEDLINE and EMBASE databases for clinical trials, abstracts, conference proceedings, and review articles dealing with lactulose. STUDY SELECTION: Emphasis was placed on clinical trials where lactulose was compared with other laxatives or placebo in patient populations where the diagnosis of constipation was reasonably established. DATA EXTRACTION: The methodology and results from clinical studies were evaluated. Assessment of the studies was made based on diagnosis of constipation, prior management of patients, follow-up of patients, dosage, and adverse effects. DATA SYNTHESIS: Clinical trials in geriatric patients, terminally ill patients, children, and normal and constipated subjects were reviewed. In most instances, lactulose was compared with a placebo, without incorporating the current education on dietary techniques for improving defecation. CONCLUSIONS: Generally, clinical trials have demonstrated a beneficial response compared with placebo, although sometimes that response has been only marginally better, from a clinical point of view.

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PrabotulinumtoxinA-xvfs for the Treatment of Moderate-to-Severe Glabellar Lines

Annals of Pharmacotherapy ◽

10.1177/1060028020943527 ◽

2020 ◽

pp. 106002802094352

Author(s):

Mary B. Gadarowski ◽

Rima I. Ghamrawi ◽

Sarah L. Taylor ◽

Steven R. Feldman

Keyword(s):

Clinical Trials ◽

Phase Ii ◽

Data Extraction ◽

Botulinum Toxin Type A ◽

Botulinum Toxin Type ◽

Phase Iii ◽

Phase Iii Clinical Trials ◽

Study Selection ◽

Pubmed Database ◽

Phase Ii And Iii

Objective: PrabotulinumtoxinA-xvfs (Jeuveau), a botulinum toxin type A, was approved by the Food and Drug Administration for the temporary improvement in the appearance of moderate-to-severe glabellar lines in February 2019. This article will review phase II and III clinical trials to assess the efficacy, safety, and clinical application of this novel, aesthetic-only drug. Data sources: A systematic literature review was performed using the terms “glabellar lines AND prabotulinumtoxinA” in the PubMed database. ClinicalTrials.gov was searched to identify nonpublished studies. Study Selection and Data Extraction: Articles written in English between November 2019 and June 2020 discussing phase II and phase III clinical trials were evaluated. Data Synthesis: By the primary efficacy end point on day 30, more patients achieved a greater than 2-point improvement on the Glabellar Line Scale (GLS) at maximum frown compared with baseline on day 0. The proportions of participants who responded to treatment with prabotulinumtoxinA were 67.5% and 70.4% versus 1.2% and 1.3% in placebo groups across 2 identical clinical trials ( P < 0.001). Patients receiving prabotulinumtoxinA experienced greater improvement in GLS at maximum frown on day 30 (87.2%) compared with onabotulinumtoxinA (82.8%) and placebo (4.2%; P < 0.001). PrabotulinumtoxinA was well tolerated across all studies. Relevance to Patient Care and Clinical Practice: This review provides a detailed analysis of the safety and efficacy of prabotulinumtoxinA-xvfs and includes special considerations to help guide patients and clinicians. Conclusion: PrabotulinumtoxinA is a safe and effective new addition to the repository of available treatments for the appearance of glabellar lines.

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Respiratory Syncytial Virus Immune Globulin Intravenous

Annals of Pharmacotherapy ◽

10.1177/106002809703100114 ◽

1997 ◽

Vol 31 (1) ◽

pp. 83-88 ◽

Cited By ~ 8

Author(s):

Todd L Wandstrat

Keyword(s):

Clinical Trials ◽

Respiratory Syncytial Virus ◽

Immune Globulin ◽

Data Extraction ◽

Safety Data ◽

Infants And Children ◽

Medline Search ◽

Study Selection ◽

Syncytial Virus ◽

In Infants And Children

OBJECTIVE: To review the clinical data detailing the use of respiratory syncytial virus immune globulin intravenous (RSV—IGIV) in infants and children. DATA SOURCES: A MEDLINE search (1990–1996) was used to identify all publications that dealt with RSV—IGIV clinical trials, pharmacology, and pharmacokinetics in infants and children. Bibliographies of articles were also used. STUDY SELECTION: All abstracts and clinical trials were reviewed. DATA EXTRACTION: Study design, population, efficacy, and safety data were retained. DATA SYNTHESIS: RSV—IGIV is an immunoglobulin product with serum neutralizing titers against RSV. It has been shown to reduce hospital stay, admissions, intensive care unit admissions, and mechanical ventilation days in infants and children with RSV pneumonia or bronchiolitis who are younger than 24 months of age and were born prematurely, or have bronchopulmonary dysplasia. RSV—IGIV is well tolerated by infants and children. CONCLUSIONS: RSV—IGIV is an effective prophylactic agent against serious RSV disease in select groups of infants and children.

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The Revised Starling Equation: The Debate of Albumin Versus Crystalloids Continues

Annals of Pharmacotherapy ◽

10.1177/1060028020907084 ◽

2020 ◽

Vol 54 (9) ◽

pp. 921-927

Author(s):

Brian L. Erstad

Keyword(s):

Clinical Trials ◽

Data Extraction ◽

Plasma Expansion ◽

Fluid Exchange ◽

Data Synthesis ◽

Study Selection ◽

Endothelial Cell Layer ◽

Resuscitation Fluid ◽

Intravenous Fluid Administration ◽

Crystalloid Solutions

Objectives: The purpose of this critical narrative review is to discuss the revised Starling equation for microvascular fluid exchange and the associated implications for intravenous fluid administration. Data Sources: PubMed (1946 to December 2019) and EMBASE (1947 to December 2019) were used, and bibliographies of retrieved articles were searched for additional articles. Study Selection and Data Extraction: Articles pertaining to the revised Starling equation and microvascular fluid exchange. Additionally, prospective human studies involving the disposition and oncotic action of radiolabeled albumin and large randomized trials comparing fluid requirements associated with isotonic crystalloid and albumin administration were included. Data Synthesis: In the revised Starling equation, oncotic forces act across the endothelial cell layer, more specifically between the fluid in the vessel lumen and the protein-sparse subglycocalyx space. The revised Starling equation and radiolabeled investigations of albumin necessitate a reconsideration of conventional views of the plasma-expanding properties of exogenous albumin. Large clinical trials demonstrate that the administration of iso-oncotic or hyper-oncotic albumin solutions in patients undergoing resuscitation does not have the reductions in fluid requirements anticipated from a traditional understanding of the oncotic actions of albumin. Relevance to Patient Care and Clinical Practice: When used as a resuscitation fluid, albumin does not have the degree of plasma expansion or intravascular retention commonly used to justify its use. Conclusions: The principles underlying the revised Starling equation in conjunction with data from radiolabeled studies of albumin and large clinical trials demonstrate that albumin does not have the perceived degree of plasma expansion or duration of intravascular retention beyond crystalloid solutions predicted by the classic Starling equation.

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