Facing the Ethical Challenges: Consumer Involvement in COVID-19 Pandemic Research.

Consumer involvement in clinical research is an essential component of a comprehensive response during emergent health challenges. During the COVID-19 pandemic, the moderation of research policies and regulation to facilitate research may raise ethical issues. Meaningful, diverse consumer involvement can help to identify practical approaches to prioritize, design, and conduct rapidly developed clinical research amid current events. Consumer involvement might also elucidate the acceptability of flexible ethics review approaches that aim to protect participants whilst being sensitive to the challenging context in which research is taking place. This article describes the main ethical challenges arising from pandemic research and how involving consumers and the community could enable resolution of such issues.

In vitro Analysis of the Hemostatic Properties of Whole Blood Products Prepared with a Platelet-Sparing Leukoreduction Filter.

Background: Warm fresh whole blood (WFWB) is an ideal resuscitation fluid for exsanguinating patients but there are myriad logistic and infectious issues associated with its use. Cold whole blood (CWB) may be an acceptable alternative to the reconstituted whole blood (RWB), the current standard of care. A leukoreduction filter has been developed which maintains platelet count while eliminating white blood cells but its effect on platelet function is unknown. We hypothesize that CWB will retain an acceptable functional coagulation profile after filtration and over time. Study Design and Methods: WFWB and CWB samples were obtained from eight donors and four units of RWB were created. The quantitative and qualitative in vitro coagulation profiles of WFWB, RWB, and CWB over time were compared. Results: Filtration was successful at removing white blood cells (5.5 ± 1.2 vs. 0.3 ± 0.3 × 106/L) while retaining an adequate platelet count (172.0 ± 47.0 to 166.0 ± 42.3 × 109/L) and hemoglobin concentration (13.7 ± 0.5 vs. 13.0 ± 0.7 g/dL). Rotational Thromboelastography (ROTEM) results revealed a similar clotting time (CT) before and after filtration (64.9 ± 5.1 vs. 64.1 ± 6.8 s) but a decreased maximum clot firmness (MCF) (58.6 ± 4.2 vs. 54.9 ± 4.6 mm). Platelet aggregation decreased substantially (28.8 ± 6.7 vs. 9.3 ± 2.1 ohm) immediately after filtration. CWB function continued to diminish over time. Conclusion: CWB holds great promise as a surrogate for WFWB, but use of a platelet-sparing LR filter diminishes platelet function almost immediately after filtration.

Phosphine-imine and -enamido ligands for acceptorless dehydrogenation catalysis.

A highly tunable phosphine-imine ligand family is introduced. Following metallation with ruthenium, deprotonation of the ligand affords a phosphine-enamido species. Complexes with the ligand in both the imine and enamido forms are active toward acceptorless dehydrogenation reactions.

Catalytic cyclization and competitive deactivation with Ru(PR2NR'2) complexes.

The first successful use of the PR2NR'2 (1,5-R'-3,7-R-1,5-diaza-3,7-diphosphacyclooctane) ligand family toward an organic synthesis is described. The precatalysts [Ru(Cp)(PR2NBn2)(MeCN)]PF6 are active toward cyclization of 2-ethynylbenzyl alcohol at low catalyst loading and mild temperatures. Catalyst performance however is limited by both low conscription and by competitive deactivation.

Barriers to the reporting of medication administration errors and near misses: an interview study of nurses at a psychiatric hospital.

ACCESSIBLE SUMMARY: Medication administration errors and near misses are common including in mental health settings. Nurses should report all errors and near misses so that lessons can be learned and future mistakes avoided. We interviewed 50 nurses to find out if they would report an error that a colleague had made or if they would report a near-miss that they had. Less than half of nurses said they would report an error made by a colleague or a near-miss involving themselves. Nurses commonly said they would not report the errors or near misses because there was a good excuse for the error/near miss, because they lacked knowledge about whether it was an error/near miss or how to report it, because they feared the consequences of reporting it, or because reporting it was too much work. Mental health nurses mostly report similar reasons for not reporting errors and near misses as nurses working in general medical settings. We have not seen another study where nurses would not report an error or near miss because they thought there was a good excuse for it. Training programmes and policies should address all the reasons that prevent reporting of errors and near misses. Medication errors are a common and preventable cause of patient harm. Guidance for nurses indicates that all errors and near misses should be immediately reported in order to facilitate the development of a learning culture. However, medication errors and near misses have been under-researched in mental health settings. This study explored the reasons given by psychiatric nurses for not reporting a medication error made by a colleague, and the perceived barriers to near-miss reporting. We presented 50 nurses with clinical vignettes about error and near-miss reporting and interviewed them about their likely actions and about their views and perceptions. Less than half of participants would report an error made by a colleague (48%) or a near-miss involving themselves (40%). Thematic analysis revealed common themes for both not reporting an error or a near-miss were knowledge, fear, burden of work, and excusing the error. The first three themes are similar to results obtained from research in general medical settings, but the fourth appears to be novel. Many mental health nurses are not yet fully convinced of the need to report all errors and near misses, and that improvements could be made by increasing knowledge while reducing fear, burden of work, and excusing of errors.

Training support staff to modify fluids to appropriate safe consistencies for adults with intellectual disabilities and dysphagia: an efficacy study.

BACKGROUND: Modifying the consistency of food and drink is a strategy commonly used in the management of dysphagia for people with intellectual disabilities (ID). People with ID often depend on others for the preparation of food and drink and therefore depend on those caregivers achieving the correct consistency to keep them safe and avoid discomfort during mealtimes. Clinical experience and prior research have demonstrated that although training can improve modification, carers often find modification difficult and potentially stressful and recommend additional support for carers. Fluid consistency is often modified through the addition of powdered thickener. This study investigates the efficacy of typical training and use of consistency guides, the Thickness Indicator Model (TIM) tubes, in helping carers to modify fluids accurately. METHOD: A 3 × 3 pre-post experimental design with a control group was employed to compare the observed accuracy of modification across three groups and at three time points (pre-intervention baseline, immediately post-training intervention and 3-10 months post-training). Sixty-two paid carers who supported people with ID were recruited to participate in the study and each was randomly allocated to one of the three groups: a control group given written guidance only, a group who received typical training and written guidance and a group who received training, written guidance and the TIM tubes. RESULTS & CONCLUSIONS: Typical training resulted in significantly greater carer accuracy in modifying fluid consistencies when compared with written guidance alone. Use of the TIM tubes also significantly improved accuracy in the modification of drinks compared with the group who modified with the aid of written guidance alone. At 3-10-month follow-up only the group who received typical training alongside the TIM tubes were significantly more accurate than the Written Guidance group. Further research is warranted to ascertain the effectiveness of the training and the utility of the TIM tubes in improving accuracy over a longer time scale and in individuals' usual living environments.

Experience and acceptability of diets of varying protein content and glycemic index in an obese cohort: results from the Diogenes trial.

BACKGROUND/OBJECTIVES: To investigate acceptability and tolerability of diets of different protein and glycemic index (GI) content aimed at weight maintenance following a phase of rapid weight loss, as part of a large pan-European dietary intervention trial. SUBJECTS/METHODS: The Diogenes study (www.diogenes-eu.org) consisted of an initial 8-week rapid weight-loss phase (800-1000 kcal/day), followed by a 6-month weight maintenance intervention with five different diets varying in protein and GI content. Measurement of a range of outcomes relating to experience of the Diogenes diets in terms of acceptability, experience and mood were recorded via end of day questionnaires throughout the study. RESULTS: Weight change during the initial weight loss phase weakly, but positively correlated with acceptability of the programme (r range=-0.08 to 0.2, P 0.05, n=685 on four of five dimensions). Success at weight maintenance positively correlated with acceptance of the programme (r range=-0.21 to -0.34, P<0.001, n=540 for all five dimensions). The diets with higher protein content were more acceptable than the low protein (LP) diets, however, no differences between the high vs low GI diets were found concerning acceptability and tolerability. CONCLUSIONS: Results suggest that moderately high protein diets, compared with LP diets, are more acceptable diets for weight control in overweight individuals.

Health professionals', expert patients' and dieters' beliefs and attitudes about obesity.

BACKGROUND: Research has suggested that patients and treatment providers hold different beliefs and models of obesity. This could impact upon the consistency and quality of interventions for weight management. The present study investigated the attitudes and beliefs of health professionals, commercial weight management advisors (expert patients) and overweight and obese dieters, towards obesity. METHODS: Data were collected using a self-administered questionnaire from 287 health professionals, 85 expert patients and 116 dieters. Respondents gave their views on obesity causation and consequences, and the most efficacious means to manage obesity. Demographic data and self-reported height and weight were also collected. Factor analysis, analysis of variance and t-tests were used to analyse the data. RESULTS: Health professionals, expert patients and dieters held similar models of obesity, identifying the same causes (lifestyle causes), consequences (medical consequences) and treatments (current recommended options) of obesity/overweight. CONCLUSIONS: The findings of the present study indicate a broader similarity between beliefs and attitudes of those involved in obesity treatment and those that they aim to treat than was previously assumed. The concordance of beliefs between patients and treatment providers is an encouraging finding and may have important implications for public health strategies in this area.

An initial evaluation of a family-based approach to weight management in adolescents attending a community weight management group.

BACKGROUND: Family-based approaches are recommended for the prevention and management of childhood obesity. Given the large numbers of obese children, scalable practical solutions are required. The present study evaluated a family-based national programme that aimed to empower adolescents to adopt healthier lifestyles. METHODS: Group facilitators supporting more than six young members (11-15 years) participated in the study. A questionnaire was designed to determine the characteristics of the adult attending with the adolescent, any health professional recommendations given and the young member's integration within traditional adult weight management groups. Data on measured height and weight [and calculated body mass index (BMI)], sex and attendance were collated from member's records. RESULTS: Questionnaires were completed by 22 facilitators (15% response rate), representing data for 128 young members with complete weight data available for 106. All members had a joining BMI > 91st centile, with 68% >98th centile. The mean (SD) number of weeks attended was 12.5 (8.1), with 19% (20) having attended for more than 20 weeks with 62% still attending. A mean (SD) BMI Z-score change of 2.49 (0.72) to 2.27 (0.74) was achieved (P < 0.001). The relationship of the adult supporter to the young member was varied, with 62% either already members or joining alongside their daughter/son. Limited guidance was provided by health professionals before or during attendance. Facilitators were comfortable about the age mix within groups. CONCLUSIONS: The community weight management organisation studied takes a family-based approach and successfully supports young members to manage their weight.

Subchronic JP-8 jet fuel exposure enhances vulnerability to noise-induced hearing loss in rats.

Both laboratory and epidemiological studies published over the past two decades have identified the risk of excess hearing loss when specific chemical contaminants are present along with noise. The objective of this study was to evaluate the potency of JP-8 jet fuel to enhance noise-induced hearing loss (NIHL) using inhalation exposure to fuel and simultaneous exposure to either continuous or intermittent noise exposure over a 4-wk exposure period using both male and female Fischer 344 rats. In the initial study, male (n = 5) and female (n = 5) rats received inhalation exposure to JP-8 fuel for 6 h/d, 5 d/wk for 4 wk at concentrations of 200, 750, or 1500 mg/m³. Parallel groups of rats also received nondamaging noise (constant octave band noise at 85 dB(lin)) in combination with the fuel, noise alone (75, 85, or 95 dB), or no exposure to fuel or noise. Significant concentration-related impairment of auditory function measured by distortion product otoacoustic emissions (DPOAE) and compound action potential (CAP) threshold was seen in rats exposed to combined JP-8 plus noise exposure when JP-8 levels of 1500 mg/m³ were presented with trends toward impairment seen with 750 mg/m³ JP-8 + noise. JP-8 alone exerted no significant effect on auditory function. In addition, noise was able to disrupt the DPOAE and increase auditory thresholds only when noise exposure was at 95 dB. In a subsequent study, male (n = 5 per group) and female (n = 5 per group) rats received 1000 mg/m³ JP-8 for 6 h/d, 5 d/wk for 4 wk with and without exposure to 102 dB octave band noise that was present for 15 min out of each hour (total noise duration 90 min). Comparisons were made to rats receiving only noise, and thosereceiving no experimental treatment. Significant impairment of auditory thresholds especially for high-frequency tones was identified in the male rats receiving combined treatment. This study provides a basis for estimating excessive hearing loss under conditions of subchronic JP-8 jet fuel exposure.

Weight, body mass index and behaviour change in a commercially run lifestyle programme for young people.

BACKGROUND: There are few practical, scalable, community-based solutions that provide ongoing support to combat the recent rapid rise in obesity in young people. A commercial weight management organisation (CWMO) has developed a tailored version of its programme for young people. The present study assessed the programme's impact on self-reported body weight, body mass index (BMI; kg m(-2) ) and health-related behaviour changes in participating young people. METHODS: Seventy-nine current young members completed a web-based questionnaire on age, height, weight and self-reported eating and activity behaviours for when they joined the programme and at the time of survey. Inclusion criteria were age 11-15 years old and membership for at least 1 month. Subjects completed the questionnaire online via the CWMO website. This was a retrospective observational study without a control group. All data were self-reported. RESULTS: Mean (SD) age was 13.4 (1.4) years and start weight was 78.5 (16.7) kg; 67% were >99th centile for BMI. Mean (SD) attendance was 23 (19) weeks; weight change was -5.0 (4.5) kg; BMI change was -2.5 (2.0) kg m(-2) ; and BMI Z-score change was -0.5 (0.4) (all P < 0.001). Height increased by 0.01 (0.03) m (P < 0.01); however, height Z-score remained unchanged. Regression analysis showed that BMI Z-score change was related to increased fruit and vegetable intake (P = 0.012), as well as a decrease in avoidance of moderate and intense activity (both P < 0.003). CONCLUSIONS: This programme for overweight and obese young people helped implement behaviour and lifestyle changes that were associated with significant reductions in self-reported weight and BMI Z-score, without compromising growth in height.

Multicilin promotes centriole assembly and ciliogenesis during multiciliate cell differentiation.

Multiciliate cells function prominently in the respiratory system, brain ependyma and female reproductive tract to produce vigorous fluid flow along epithelial surfaces. These specialized cells form during development when epithelial progenitors undergo an unusual form of ciliogenesis, in which they assemble and project hundreds of motile cilia. Notch inhibits multiciliate cell formation in diverse epithelia, but how progenitors overcome lateral inhibition and initiate multiciliate cell differentiation is unknown. Here we identify a coiled-coil protein, termed multicilin, which is regulated by Notch and highly expressed in developing epithelia where multiciliate cells form. Inhibiting multicilin function specifically blocks multiciliate cell formation in Xenopus skin and kidney, whereas ectopic expression induces the differentiation of multiciliate cells in ectopic locations. Multicilin localizes to the nucleus, where it directly activates the expression of genes required for multiciliate cell formation, including foxj1 and genes mediating centriole assembly. Multicilin is also necessary and sufficient to promote multiciliate cell differentiation in mouse airway epithelial cultures. These findings indicate that multicilin initiates multiciliate cell differentiation in diverse tissues, by coordinately promoting the transcriptional changes required for motile ciliogenesis and centriole assembly.

A new x-ray interface and surface scattering environmental cell design for in situ studies of radioactive and atmosphere-sensitive samples.

We present a novel design of a purpose-built, portable sample cell for in situ x-ray scattering experiments of radioactive or atmosphere sensitive samples. The cell has a modular design that includes two independent layers of containment that are used simultaneously to isolate the sensitive samples. Both layers of containment can be flushed with an inert gas, thus serving a double purpose as containment of radiological material (either as a solid sample or as a liquid phase) and in separating reactive samples from the ambient atmosphere. A remote controlled solution flow system is integrated into the containment system that allows sorption experiments to be performed on the diffractometer. The cell's design is discussed in detail and we demonstrate the cell's performance by presenting first results of crystal truncation rod measurements. The results were obtained from muscovite mica single crystals reacted with 1 mM solutions of Th(IV) with 0.1 M NaCl background electrolyte. Data were obtained in specular as well as off-specular geometry.

Problems in identifying predictors and correlates of weight loss and maintenance: implications for weight control therapies based on behaviour change.

Weight management is a dynamic process, with a pre-treatment phase, a treatment (including process) phase and post-treatment maintenance, and where relapse is possible during both the treatment and maintenance. Variability in the statistical power of the studies concerned, heterogeneity in the definitions, the complexity of obesity and treatment success, the constructs and measures used to predict weight loss and maintenance, and an appreciation of who and how many people achieve it, make prediction difficult. In models of weight loss or maintenance: (i) predictors explain up to 20-30% of the variance; (ii) many predictors are the sum of several small constituent variables, each accounting for a smaller proportion of the variance; (iii) correlational or predictive relationships differ across study populations; (iv) inter-individual variability in predictors and correlates of outcomes is high and (v) most of the variance remains unexplained. Greater standardization of predictive constructs and outcome measures, in more clearly defined study populations, tracked longitudinally, is needed to better predict who sustains weight loss. Treatments need to develop a more individualized approach that is sensitive to patients' needs and individual differences, which requires measuring and predicting patterns of intra-individual behaviour variations associated weight loss and its maintenance. This information will help people shape behaviour change solutions to their own lifestyle needs.

Covert administration of medication to older adults: a review of the literature and published studies.

The aim of the study was to review published studies of covert medicines administration in older people, as well as carrying out a broad review of the subject. A review of MEDLINE, EMBASE, PsycINFO, BNI and CINAHL was conducted in order to identify studies providing quantitative or qualitative data on covert administration in older adults. National guidance on covert medication and the ethics and legality of the practice were also reviewed. Data were extracted from eight studies and one inspection report. In addition, one qualitative study was identified. Nine studies included a questionnaire or interview with staff and only one involved non-professional carers. Seven studies were from the UK. Disguising medication in food or drink was reported in 43-71% of nursing homes. In total, 1.5-17% of institutional patients were receiving medication covertly. Despite legislation, incomplete documentation was common and nursing staff alone often made the decision to administer medication covertly. Covert administration appears to be common in older adults with dementia but despite legislation it often takes place without documentation and consultation of all relevant parties. Staff education and training and local audit are needed to improve standards and safeguard vulnerable patients in institutions.

Off-label psychotropic prescribing for young persons in medium security.

Psychotropic drug prescribing for children and adolescents is frequently off-label and has increased over time and can be controversial. Psychotropic prescribing in two large UK medium secure units for young people has been studied. A total of 89 patients were included, 64% being aged less than 18 years. A total of 137 of 202 (67.8%) of prescriptions were off-label. The most common reasons for a prescription being off-label were the indication (N = 103) and the patient's age (N = 41). The main classes of drugs involved were antipsychotics (N = 59), antiepileptics as mood stabilisers (N = 22), anticholinergics and hyoscine (N = 15) and antidepressants (N = 11). Aggression (N = 48) and post-traumatic stress disorder (N = 30) were the most common off-label indications. Some antidepressant prescriptions were contrary to advice of the Committee on Safety of Medicines (CSM). Meta-analyses or randomised controlled trials supported 27% of off-label prescriptions, with lesser quality studies supporting a further 29.2% and expert opinion 38.7%, whereas for 5.1% no evidence could be found. Prescribers tended to over-estimate the level of evidence from clinical trials or extrapolated from findings in adults. They often quoted their own experience rather than expert sources to justify their prescribing practice. It is important that prescribers are fully aware of the quality of experimental data and the risk-benefit ratio when prescribing off-label for young persons. If the evidence base is limited, it is particularly important to provide information about the risks and benefits of the treatment to the patient/relatives. A second opinion may be helpful. Both target symptoms and side effects should be monitored and regularly reviewed.

Influence of Slimming World's lifestyle programme on diet, activity behaviour and health of participants and their families.

BACKGROUND: Understanding the impact of commercial weight management programmes on behaviour change is an area that requires greater evidence. The present study investigated the impact of a commercial weight management organisation's diet and activity programmes on the lifestyles of those accessing the services and their families. METHODS: This survey was based on self-reports from a group of people involved in their own weight control. A questionnaire consisting of multiple choice and open-ended questions regarding diet, activity patterns and health was distributed in a commercial slimming organisation's magazine and was available on the website for a 4 week period. Two thousand eight hundred and twelve respondents were analysed, including the organisation's members (53%) and nonmembers (47%). RESULTS: Those following the dietary programme reported significant changes towards healthier food choices in line with current guidelines (P < 0.01). Over 80% reported an improvement in their own health and over 26% reported an improvement in their partner's or family's health (P < 0.01). Respondents reported increasing physical activity after being made aware of the organisation's activity programme (P < 0.001). Members were more likely to have become more active than nonmembers (P = 0.011). The longer respondents had been members, the more likely they were to report an increased participation in physical activity (P = 0.02). Half of those reporting increased activity indicated that their partner or whole family had also increased their activity levels. CONCLUSIONS: The commercial slimming organisation's programme appeared to be having a beneficial impact on the diet and activity behaviours of those accessing the service. Group members were more likely to make positive behaviour changes and health improvements tended to increase with the duration of membership. The improvements observed with respect to both diet and activity levels also reached the wider family network.

Transfusion service disaster planning.

The Mayo Clinic, in Rochester, Minnesota, recently set forth a directive to develop a Mayo Emergency Incident Command System (MEICS) plan to respond to major disasters. The MEICS plan that was developed interfaces with national response plans to ensure effective communication and coordination between our institution and local, state, and federal agencies to establish a common language and communication structure. The MEICS plan addresses multiple aspects of dealing with resource needs during a crisis, including the need for blood and transfusion medicine services. The MEICS plan was developed to supplement our current local emergency preparedness procedures and provide a mechanism for responding to the escalating severity of an emergency to deal with situations of a magnitude that is outside the normal experience. A plan was developed to interface the existing Transfusion Medicine disaster plan standard operating procedures (SOP) with the institutional and Department of Laboratory Medicine (DLMP) MEICS plans. The first step in developing this interface was defining MEICS. Other major steps were defining the chain of command, developing a method for visually indicating who is "in charge," planning communication, defining the actions to be taken, assessing resource needs, developing flowcharts and updating SOPs, and developing a blood rationing team to deal with anticipated blood shortages. Several key features of the interface and updated disaster plan that were developed are calling trees for response personnel, plans for relocating leadership to alternative command centers, and action sheets to assist with resource assessment. The action sheets also provide documentation of key actions by response personnel.

Red blood cell transfusion in a patient with anti-AnWj: a case report.

Anti-AnWj (Anton) has been associated with clinically significant hemolytic transfusion reactions. More than 99 percent of studied populations have RBCs that express the antigen. Reported here is a patient with anti-AnWj who was transfused with antigen-positive RBCs without adverse reaction.