Statistical Evaluations of the Reproducibility and Reliability of 3-Tesla High Resolution Magnetization Transfer Brain Images: A Pilot Study on Healthy Subjects

Magnetization transfer imaging (MT) may have considerable promise for early detection and monitoring of subtle brain changes before they are apparent on conventional magnetic resonance images. At 3 Tesla (T), MT affords higher resolution and increased tissue contrast associated with macromolecules. The reliability and reproducibility of a new high-resolution MT strategy were assessed in brain images acquired from 9 healthy subjects. Repeated measures were taken for 12 brain regions of interest (ROIs): genu, splenium, and the left and right hemispheres of the hippocampus, caudate, putamen, thalamus, and cerebral white matter. Spearman's correlation coefficient, coefficient of variation, and intraclass correlation coefficient (ICC) were computed. Multivariate mixed-effects regression models were used to fit the mean ROI values and to test the significance of the effects due to region, subject, observer, time, and manual repetition. A sensitivity analysis of various model specifications and the corresponding ICCs was conducted. Our statistical methods may be generalized to many similar evaluative studies of the reliability and reproducibility of various imaging modalities

Long-term retention on treatment with lumiracoxib 100 mg once or twice daily compared with celecoxib 200 mg once daily: A randomised controlled trial in patients with osteoarthritis

BACKGROUND: The efficacy, safety and tolerability of lumiracoxib, a novel selective cyclooxygenase-2 (COX-2) inhibitor, has been demonstrated in previous studies of patients with osteoarthritis (OA). As it is important to establish the long-term safety and efficacy of treatments for a chronic disease such as OA, the present study compared the effects of lumiracoxib at doses of 100 mg once daily (o.d.) and 100 mg twice daily (b.i.d.) with those of celecoxib 200 mg o.d. on retention on treatment over 1 year. METHODS: In this 52-week, multicentre, randomised, double-blind, parallel-group study, male and female patients (aged at least 40 years) with symptomatic primary OA of the hip, knee, hand or spine were randomised (1:2:1) to lumiracoxib 100 mg o.d. (n = 755), lumiracoxib 100 mg b.i.d. (n = 1,519) or celecoxib 200 mg o.d. (n = 758). The primary objective of the study was to demonstrate non-inferiority of lumiracoxib at either dose compared with celecoxib 200 mg o.d. with respect to the 1-year retention on treatment rate. Secondary outcome variables included OA pain in the target joint, patient's and physician's global assessments of disease activity, Short Arthritis assessment Scale (SAS) total score, rescue medication use, and safety and tolerability. RESULTS: Retention rates at 1 year were similar for the lumiracoxib 100 mg o.d., lumiracoxib 100 mg b.i.d. and celecoxib 200 mg o.d. groups (46.9% vs 47.5% vs 45.3%, respectively). It was demonstrated that retention on treatment with lumiracoxib at either dose was non-inferior to celecoxib 200 mg o.d. Similarly, Kaplan-Meier curves for the probability of premature discontinuation from the study for any reason were similar across the treatment groups. All three treatments generally yielded comparable results for the secondary efficacy variables and all treatments were well tolerated. CONCLUSION: Long-term treatment with lumiracoxib 100 mg o.d., the recommended dose for OA, was as effective and well tolerated as celecoxib 200 mg o.d. in patients with OA. TRIAL REGISTRATION: clinicaltrials.gov NCT00145301

Disclosures and Conflicts of Interest: Solving the Riddle, Wrapped in a Mystery, Inside an Enigma

PURPOSE: Confusion exists around the nature and best practices for authors in biomedical fields seeking to disclose conflicts of interest (COIs) and other information that can produce bias. Guidelines often provide principles for action and to avoid granularity that can limit their general usefulness. Journal editors must also interpret various guidelines to produce and enhance their own disclosure and COI policies. We discussion COIs and present heuristics that can enhance disclosure practices by individual authors and inform policy and practice among medical journal editors. METHODS: The authors reviewed the biomedical literature and drew on professional and academic experience to develop examples and a suggested matrix for decision making. FINDINGS: Most COI commentary centers on financial relationships. Disagreement still exists about the nature and impact of various forms of COI, making critical reasoning essential when making and interpreting disclosures. Journal editors, authors, critics, and other experts express varying opinions about best practices regarding COIs. Policy decisions should be balanced and reasonable. Narrative context may help readers understand the meaning and relevance of disclosures and COIs. IMPLICATIONS: A balance of personal responsibility and critical thinking can enhance disclosure practices as well as confidence in the medical literature. Using a heuristic to think through possible areas of conflict can help authors provide more complete disclosure information. Providing narrative context can ease the burden of peer reviewers, editors, and readers trying to understand disclosures

Disclosures and Conflicts of Interest: Solving the Riddle, Wrapped in a Mystery, Inside an Enigma

PURPOSE: Confusion exists around the nature and best practices for authors in biomedical fields seeking to disclose conflicts of interest (COIs) and other information that can produce bias. Guidelines often provide principles for action and to avoid granularity that can limit their general usefulness. Journal editors must also interpret various guidelines to produce and enhance their own disclosure and COI policies. We discussion COIs and present heuristics that can enhance disclosure practices by individual authors and inform policy and practice among medical journal editors. METHODS: The authors reviewed the biomedical literature and drew on professional and academic experience to develop examples and a suggested matrix for decision making. FINDINGS: Most COI commentary centers on financial relationships. Disagreement still exists about the nature and impact of various forms of COI, making critical reasoning essential when making and interpreting disclosures. Journal editors, authors, critics, and other experts express varying opinions about best practices regarding COIs. Policy decisions should be balanced and reasonable. Narrative context may help readers understand the meaning and relevance of disclosures and COIs. IMPLICATIONS: A balance of personal responsibility and critical thinking can enhance disclosure practices as well as confidence in the medical literature. Using a heuristic to think through possible areas of conflict can help authors provide more complete disclosure information. Providing narrative context can ease the burden of peer reviewers, editors, and readers trying to understand disclosures

Assistant Editors\u27 Interview with Dr. Lisa DeTora of Hofstra University

In issue 1.1 of RHM, Dr. Lisa DeTora, Assistant Professor and Director of STEM Writing at Hofstra University, contributes a research article titled: “The Dangers of Magical Thinking: Situating Right To Try Laws, Patient’s Rights, and the Language of Advocacy To download a transcription of this interview, (will open in a new window). See more on Dr. DeTora\u27s work at: https://www.hofstra.edu/faculty/fac_profiles.cfm?id=4710&t=/Academics/Colleges/HCLAS/WRITING

Dental Care in Times of the COVID-19 Pandemic: A Review

Given the dynamic relationship between oral and general health, dental care must not be neglected even during a public health emergency. Nevertheless, the fear of contracting the infection appears to have caused instances of dental treatment avoidance. In these times of uncertainty, regulatory and public health organizations have made numerous and sometimes controversial recommendations to practitioners and to the public about how to secure their oral health care needs. Dentists, as advocates of oral health, should actively maintain their practices while considering local epidemiological reports and recommendations regarding prevention of SARS-CoV-2 infection. Providing appropriate safety measures, accurate triage and prioritization of patients, notice to susceptible communities, remote health care delivery when appropriate, and epidemiological reports of COVID-19 (whenever possible) are all critical considerations for dental practitioners