Measuring quality of life in mental health: Are we asking the right questions?

Measuring quality-adjusted-life years using generic preference-based quality of life measures is common practice when evaluating health interventions. However, there are concerns that measures in common use, such as the EQ-5D and SF-6D, focus overly on physical health and therefore may not be appropriate for measuring quality of life for people with mental health problems. The aim of this research was to identify the domains of quality of life that are important to people with mental health problems in order to assess the content validity of these generic measures. Qualitative semi-structured interviews were conducted with 19 people, recruited from UK mental health services, with a broad range of mental health problems at varying levels of severity. This complemented a previous systematic review and thematic synthesis of qualitative studies on the same topic. Seven domains important to quality of life for people with mental health problems were identified: well-being and ill-being; relationships and a sense of belonging; activity; self-perception; autonomy, hope and hopelessness; and physical health. These were consistent with the systematic review, with the addition of physical health as a domain, and revealed a differing emphasis on the positive and negative aspects of quality of life according to the severity of the mental health problems. We conclude that the content of existing generic preference-based measures of health do not cover this domain space well. Additionally, because people may experience substantial improvements in their quality of life without registering on the positive end of a quality of life scale, it is important that the full spectrum of negative through to positive aspects of each domain are included in any quality of life measure

Dataset of manually measured QT intervals in the electrocardiogram

BACKGROUND: The QT interval and the QT dispersion are currently a subject of considerable interest. Cardiac repolarization delay is known to favor the development of arrhythmias. The QT dispersion, defined as the difference between the longest and the shortest QT intervals or as the standard deviation of the QT duration in the 12-lead ECG is assumed to be reliable predictor of cardiovascular mortality. The seventh annual PhysioNet/Computers in Cardiology Challenge, 2006 addresses a question of high clinical interest: Can the QT interval be measured by fully automated methods with accuracy acceptable for clinical evaluations? METHOD: The PTB Diagnostic ECG Database was given to 4 cardiologists and 1 biomedical engineer for manual marking of QRS onsets and T-wave ends in 458 recordings. Each recording consisted of one selected beat in lead II, chosen visually to have minimum baseline shift, noise, and artifact. In cases where no T wave could be observed or its amplitude was very small, the referees were instructed to mark a 'group-T-wave end' taking into consideration leads with better manifested T wave. A modified Delphi approach was used, which included up to three rounds of measurements to obtain results closer to the median. RESULTS: A total amount of 2*5*548 Q-onsets and T-wave ends were manually marked during round 1. To obtain closer to the median results, 8.58 % of Q-onsets and 3.21 % of the T-wave ends had to be reviewed during round 2, and 1.50 % Q-onsets and 1.17 % T-wave ends in round 3. The mean and standard deviation of the differences between the values of the referees and the median after round 3 were 2.43 ± 0.96 ms for the Q-onset, and 7.43 ± 3.44 ms for the T-wave end. CONCLUSION: A fully accessible, on the Internet, dataset of manually measured Q-onsets and T-wave ends was created and presented in additional file: 1 (Table 4) with this article. Thus, an available standard can be used for the development of automated methods for the detection of Q-onsets, T-wave ends and for QT interval measurements

Fear of hypoglycaemia: defining a minimum clinically important difference in patients with type 2 diabetes

<p>Abstract</p> <p>Background</p> <p>To explore the concept of the Minimum Clinically Important Difference (MID) of the Worry Scale of the Hypoglycaemia Fear Survey (HFS-II) and to quantify the clinical importance of different types of patient-reported hypoglycaemia.</p> <p>Methods</p> <p>An observational study was conducted in Germany with 392 patients with type 2 diabetes mellitus treated with combinations of oral anti-hyperglycaemic agents. Patients completed the HFS-II, the Treatment Satisfaction Questionnaire for Medication (TSQM), and reported on severity of hypoglycaemia. Distribution- and anchor-based methods were used to determine MID. In turn, MID was used to determine if hypoglycaemia with or without need for assistance was clinically meaningful compared to having had no hypoglycaemia.</p> <p>Results</p> <p>112 patients (28.6%) reported hypoglycaemic episodes, with 15 patients (3.8%) reporting episodes that required assistance from others. Distribution- and anchor-based methods resulted in MID between 2.0 and 5.8 and 3.6 and 3.9 for the HFS-II, respectively. Patients who reported hypoglycaemia with (21.6) and without (12.1) need for assistance scored higher on the HFS-II (range 0 to 72) than patients who did not report hypoglycaemia (6.0).</p> <p>Conclusion</p> <p>We provide MID for HFS-II. Our findings indicate that the differences between having reported no hypoglycaemia, hypoglycaemia without need for assistance, and hypoglycaemia with need for assistance appear to be clinically important in patients with type 2 diabetes mellitus treated with oral anti-hyperglycaemic agents.</p

Serious adverse events reported in placebo randomised controlled trials of oral naltrexone: a systematic review and meta-analysis

Background Naltrexone is an opioid antagonist used in many different conditions, both licensed and unlicensed. It is used at widely varying doses from 3 - 250 mg. The aim of this review was to evaluate the safety of oral naltrexone by examining the risk of serious adverse events (SAEs) in randomised controlled trials (RCTs) of naltrexone compared to placebo. Methods A systematic search of Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, other databases and clinical trials registries was undertaken up to March 2018. Parallel placebo-controlled RCTs longer than 4 weeks published after 1/1/2001, of oral naltrexone at any dose were selected. Any condition and age group were included, excluding only studies for opioid or ex-opioid users, due to possible opioid/opioid antagonist interactions. The systematic review used the guidance of the Cochrane Handbook throughout. Numerical data was independently extracted by two people and cross-checked. Risk of bias was assessed with the Cochrane Risk of Bias Tool. Meta-analyses were performed using Stata 15 and R, using random and fixed effects models throughout. Results Eighty-nine RCTs with 11194 participants were found, studying alcohol use disorders, various psychiatric disorders, impulse control disorders, other addictions, obesity, Crohn’s disease, fibromyalgia and cancers. Twenty-six studies (4,960 participants) recorded SAEs occurring by arm of study. There was no evidence of increased risk of SAEs for naltrexone compared to placebo, relative risk (RR) 0.84 (95% CI: 0.66 to 1.06). Sensitivity analyses pooling risk differences supported this conclusion (RD = -0.01 (-0.02, 0.00)) and subgroup analyses showed that results were consistent across different doses and disease groups. The quality of evidence for this outcome was judged high using the GRADE criteria. Conclusions Naltrexone does not appear to increase the risk of SAEs over placebo. These findings confirm the safety of naltrexone when used in licensed indications and encourage investments to undertake efficacy studies in unlicensed indications

Challenge of conducting a placebo-controlled randomized efficacy study for influenza vaccine in a season with low attack rate and a mismatched vaccine B strain: a concrete example

<p>Abstract</p> <p>Background</p> <p>Our aim was to determine the efficacy of a trivalent inactivated split virus influenza vaccine (TIV) against culture-confirmed influenza A and/or B in adults 18 to 64 years of age during the 2005/2006 season in the Czech Republic.</p> <p>Methods</p> <p>6203 subjects were randomized to receive TIV (N = 4137) or placebo (N = 2066). The sample size was based on an assumed attack rate of 4% which provided 90% power to reject the hypothesis that vaccine efficacy (VE) was ≥ 45%. Cases of influenza like illness (defined as fever (oral temperature ≥37.8°C) plus cough and/or sore throat) were identified both by active (biweekly phone contact) and passive (self reporting) surveillance and nasal and throat swabs were collected from subjects for viral culture.</p> <p>Results</p> <p>TIV was well tolerated and induced a good immune response. The 2005/2006 influenza season was exceptionally mild in the study area, as it was throughout Europe, and only 46 culture-confirmed cases were found in the study cohort (10 influenza A and 36 influenza B). Furthermore among the B isolates, 35 were identified as B/Hong Kong 330/2001-like (B/Victoria/2/87 lineage) which is antigenically unrelated to the vaccine B strain (B/Yamagata/16/88 lineage). The attack rate in the vaccine group (0.7%) was not statistically significantly different from the attack rate in the placebo group (0.9%).</p> <p>Conclusion</p> <p>Due to the atypical nature of the influenza season during this study we were unable to assess TIV efficacy. This experience illustrates the challenge of conducting a prospective influenza vaccine efficacy trial during a single season when influenza attack rates and drift in circulating strains or B virus lineage match can be difficult to estimate in advance.</p> <p>Trial Registration</p> <p>Clinical trial registery: NCT00197223.</p

Environmental Geotechnics: Challenges and Opportunities in the Post COVID-19 World

The outbreak of the COVID-19 pandemic not only created a health crisis across the world but is expected to negatively impact the global economy and societies at a scale that maybe larger than the 2008 financial crisis. Simultaneously, it has inevitably exerted many negative consequences on the geoenvironment upon which human beings depend. The current article articulates the role of environmental geotechnics to elucidate and mitigate the effects of the current pandemic. It is the belief of all authors that the COVID-19 pandemic presents significant challenges, but also opportunities for the development of our field. Our discipline should make full use of our professional skills and expertise to look for development opportunities from this crisis, to highlight our discipline’s irreplaceable position in the global fight against pandemics, and to contribute to the health and prosperity of our communities, so as to better serve humankind. In order to reach this goal, while taking into account the specificity of the SARS-CoV-2 and the uncertainty of its environmental effects, it is believed that more emphasis should be placed on the following research directions: pathogen-soil interactions, isolation and remediation technologies for pathogen-contaminated sites, new materials for pathogen-contaminated soil, recycling and safe disposal of medical wastes, quantification of uncertainty in geoenvironmental and epidemiological problems, emerging technologies and adaptation strategies in civil, geotechnical, and geoenvironmental infrastructure, pandemic-induced environmental risk management, and model pathogen transport and fate in geoenvironment, among others. Moreover, COVID-19 has made it clear to the environmental geotechnics community the importance of urgent international cooperation and of multidisciplinary research actions that must extend to a broad range of scientific fields, including medical and public health disciplines, in order to meet the complexities posed by the COVID-19 pandemic