A pilot study to test psychophonetics methodology for self-care and empathy in compassion fatique, burnout and secondary traumatic stress

Background: Home-based care is recognised as being a stressful occupation. Practitioners working with patients experiencing high levels of trauma may be susceptible to compassion fatigue, with the sustained need to remain empathic being a contributing factor. Objectives: The aim of this research was to evaluate psychophonetics methodology for selfcare and empathy skills as an intervention for compassion fatigue. Objectives were to measure levels of compassion fatigue pre-intervention, then to apply the intervention and retest levels one month and six months post-intervention. Method: The research applied a pilot test of a developed intervention as a quasi-experiment. The study sample comprised home-based carers working with HIV-positive patients at a hospice in Grabouw, a settlement in the Western Cape facing socioeconomic challenge. Results: The result of the pilot study showed a statistically-significant improvement in secondary traumatic stress, a component of compassion fatigue, measured with the ProQOL v5 instrument post-intervention. Conclusion: The results gave adequate indication for the implementation of a larger study in order to apply and test the intervention. The study highlights a dire need for further research in this field.Department of HE and Training approved lis

Location of community pharmacies and prevalence of oral conditions in the Western Cape Province

Community pharmacists are approached regularly for oral health advice; most commonly for ulcers which could be indicative of oral cancer, HIV, and various systemic diseases. Community pharmacists should know how to manage these conditions yet they have very limited training to manage these conditions appropriately. The area location and socioeconomic status (SES) of the pharmacy should be considered as it may influence patient management. A study of this nature has not yet been conducted in the Western Cape Province of South Africa. To determine the prevalence and frequency of oral complaints at community pharmacies and if these parameters differ by metropolitan location and SES. A cross-sectional survey of 162 randomlyselected private sector pharmacies was conducted. The sample (n = 121) was stratified by SES and metropolitan location. An open-ended structured questionnaire was faxed to pharmacists. A telephonic interview was conducted a day later. Community pharmacists were asked about the frequency and type of oral health problems they encountered. Most pharmacists (91%) dealt with oral health problems frequently, most commonly for ulcers (55.8%), thrush (49.2%), and toothache (33.3%). The results did not differ by metropolitan location and SES (Chi-squared, Fisher’s Exact, p > 0.05), with the exception of toothache and mouth sores. Community pharmacists are an important part of an interdisciplinary team, and play a definite role in the early detection of oral health conditions, namely, caries, HIV and oral cancer. Training on common oral health conditions should be included in undergraduate pharmacy curricula and continuous professional development courses.Department of HE and Training approved lis

Provision of syndromic treatment of sexually transmitted infections by community pharmacists: a potentially underutilized HIV prevention strategy

Background: Sexually transmitted infections (STIs) are known risk factors for HIV infection. Goal: The goal of this study was to assess the current and potential future role that community pharmacists in Western Cape, South Africa play in the treatment of STIs. Study Design: A cross-sectional survey of community pharmacists in the Western Cape region of South Africa. A face-to-face interview that ascertained experience with requests from patients for STI treatment, current STI treatment practices, and willingness to provide syndromic STI treatment was administered to head pharmacists. Results: Ninety pharmacies were selected and 85 (94%) of the head pharmacists participated; 55 from an urban area and 30 from a rural area. Pharmacists reported a median of 40 urban clients and 25 rural clients who sought STI treatment from community pharmacists. When provided with a hypothetical clinical situation, 13% of urban and 17% of rural pharmacists identified the correct medication for male urethral discharge, 8% of urban pharmacists and none of the rural pharmacists identified correct treatment for genital ulcers, and none of the pharmacists identified the correct medication for vaginal discharge. Fifty-three percent of pharmacists in urban regions and 47% of pharmacists in rural regions expressed willingness to provide syndromic STI treatment. Independent predictors of willingness to provide syndromic treatment were knowledge of the link between HIV transmission and STIs (adjusted odds ratio [OR]: 13.78; 95% CI: 2.69,70.66), past experience prescribing syndromic STI treatment (OR: 11.1; 95% CI: 1.14, 108.6), and male gender (OR: 4.38; 95% CI: 1.15, 16.7). Conclusions: Pharmacists are frequently called upon to provide STI treatment but have limited knowledge of correct treatment recommendations. Training pharmacists to provide syndromic STI treatment may be one strategy to reduce STI morbidity and HIV transmission.IS

Setting up a clinical trial in care homes: challenges encountered and recommendations for future research practice

Background: Older adults in care homes have increasingly complex health care needs, and care provision should be evidence-based whenever possible. However, recruitment of frail, older people to research is a complex process and often results in care home residents being excluded from research participation. This paper draws on the experience of setting up a randomised controlled trial to determine the effectiveness of probiotics on antibiotic-associated diarrhoea in care home residents [Probiotics for Antibiotic Associated Diarrhoea in Care Homes (PAAD) Study] in Wales. Findings: Significant challenges were encountered setting up a clinical trial in care homes. There were a number of barriers and facilitative factors encountered that were unique to this research setting. The classification of the study intervention (a widely available food supplement with a low risk safety profile) as an investigational medicinal product, with the associated requirements including obtaining statutory approvals and research governance, had a major impact. Conclusion: The process for setting up a clinical trial of an investigational medicinal product in care homes has been more complex and time consuming than the process for setting up an observational study in the same setting, and clinical trials in other health care settings. We recommend regulatory changes to ensure approvals processes are more proportionate to risk and context, to ensure that care home residents have the opportunity to participate in research and are able to help generate much needed evidence to underpin care. Recommendations made may inform future research practice

Rehabilitation following rotator cuff repair: A multi-centre pilot & feasibility randomised controlled trial (RaCeR)

Objective: To evaluate the feasibility of a multi-centre randomised controlled trial to compare the clinical and cost-effectiveness of early patient-directed rehabilitation versus standard rehabilitation following surgical repair of the rotator cuff of the shoulder. Design: Two-arm, multi-centre pilot and feasibility randomised controlled trial. Setting: Five National Health Service hospitals in England. Participants: Adults (n = 73) with non-traumatic rotator cuff tears scheduled for repair were recruited and randomly allocated remotely prior to surgery. Interventions: Early patient-directed rehabilitation (n = 37); advised to remove their sling as soon as able and move as symptoms allow. Standard rehabilitation (n = 36); sling immobilisation for four weeks. Measures: (1) Randomisation of 20% or more eligible patients. (2) Difference in time out of sling of 40% or more between groups. (3) Follow-up greater than 70%. Results: 73/185 (39%) potentially eligible patients were randomised. Twenty participants were withdrawn, 11 due to not receiving rotator cuff repair. The between-group difference in proportions of participants who exceeded the cut-off of 222.6 hours out of the sling was 50% (80% CI = 29%, 72%), with the early patient-directed rehabilitation group reporting greater time out of sling. 52/73 (71%) and 52/53 (98%) participants were followed-up at 12 weeks when withdrawals were included and excluded respectively. Eighteen full-thickness re-tears were reported (early patient-directed rehabilitation = 7, standard rehabilitation = 11). Five serious adverse events were reported. Conclusion: A main randomised controlled trial is feasible but would require allocation of participants following surgery to counter the issue of withdrawal due to not receiving surgery

In Vitro Proliferation of Adult Human Beta-Cells

A decrease in functional beta-cell mass is a key feature of type 2 diabetes. Glucagon-like peptide 1 (GLP-1) analogues induce proliferation of rodent beta-cells. However, the proliferative capacity of human beta-cells and its modulation by GLP-1 analogues remain to be fully investigated. We therefore sought to quantify adult human beta-cell proliferation in vitro and whether this is affected by the GLP-1 analogue liraglutide

The cellular redox environment alters antigen presentation

Cysteine-containing peptides represent an important class of T cell epitopes, yet their prevalence remains underestimated. We have established and interrogated a database of around 70,000 naturally processed MHC-bound peptides and demonstrate that cysteine-containing peptides are presented on the surface of cells in an MHC allomorph-dependent manner and comprise on average 5-10% of the immunopeptidome. A significant proportion of these peptides are oxidatively modified, most commonly through covalent linkage with the antioxidant glutathione. Unlike some of the previously reported cysteine-based modifications, this represents a true physiological alteration of cysteine residues. Furthermore, our results suggest that alterations in the cellular redox state induced by viral infection are communicated to the immune system through the presentation of S-glutathionylated viral peptides, resulting in altered T cell recognition. Our data provide a structural basis for how the glutathione modification alters recognition by virus-specific T cells. Collectively, these results suggest that oxidative stress represents a mechanism for modulating the virus-specific T cell response.This work was supported, in whole or in part, by National Institutes of Health Grant R01 NS036592. This work was also supported by an infrastructure grant (Grant LE100100036) from the Australian Research Council (ARC) and a project grant from the Juvenile Diabetes Research Foundation (17-2012-134)

Updated standardized definitions for efficacy endpoints in adjuvant breast cancer clinical trials: STEEP Version 2.0

Purpose The Standardized Definitions for Efficacy End Points (STEEP) criteria, established in 2007, provide standardized definitions of adjuvant breast cancer clinical trial end points. Given the evolution of breast cancer clinical trials and improvements in outcomes, a panel of experts reviewed the STEEP criteria to determine whether modifications are needed.Methods We conducted systematic searches of ClinicalTrials.gov for adjuvant systemic and local-regional therapy trials for breast cancer to investigate if the primary end points reported met STEEP criteria. On the basis of common STEEP deviations, we performed a series of simulations to evaluate the effect of excluding non-breast cancer deaths and new nonbreast primary cancers from the invasive disease-free survival end point.Results Among 11 phase III breast cancer trials with primary efficacy end points, three had primary end points that followed STEEP criteria, four used STEEP definitions but not the corresponding end point names, and four used end points that were not included in the original STEEP manuscript. Simulation modeling demonstrated that inclusion of second nonbreast primary cancer can increase the probability of incorrect inferences, can decrease power to detect clinically relevant efficacy effects, and may mask differences in recurrence rates, especially when recurrence rates are low.Conclusion We recommend an additional end point, invasive breast cancer-free survival, which includes all invasive disease-free survival events except second nonbreast primary cancers. This end point should be considered for trials in which the toxicities of agents are well-known and where the risk of second primary cancer is small. Additionally, we provide end point recommendations for local therapy trials, low-risk populations, noninferiority trials, and trials incorporating patient-reported outcomes

Rehabilitation following rotator cuff repair: A multi-centre pilot & feasibility randomised controlled trial (RaCeR)

Objective: To evaluate the feasibility of a multi-centre randomised controlled trial to compare the clinical and cost-effectiveness of early patient-directed rehabilitation versus standard rehabilitation following surgical repair of the rotator cuff of the shoulder. Design: Two-arm, multi-centre pilot and feasibility randomised controlled trial. Setting: Five National Health Service hospitals in England. Participants: Adults (n = 73) with non-traumatic rotator cuff tears scheduled for repair were recruited and randomly allocated remotely prior to surgery. Interventions: Early patient-directed rehabilitation (n = 37); advised to remove their sling as soon as able and move as symptoms allow. Standard rehabilitation (n = 36); sling immobilisation for four weeks. Measures: (1) Randomisation of 20% or more eligible patients. (2) Difference in time out of sling of 40% or more between groups. (3) Follow-up greater than 70%. Results: 73/185 (39%) potentially eligible patients were randomised. Twenty participants were withdrawn, 11 due to not receiving rotator cuff repair. The between-group difference in proportions of participants who exceeded the cut-off of 222.6 hours out of the sling was 50% (80% CI = 29%, 72%), with the early patient-directed rehabilitation group reporting greater time out of sling. 52/73 (71%) and 52/53 (98%) participants were followed-up at 12 weeks when withdrawals were included and excluded respectively. Eighteen full-thickness re-tears were reported (early patient-directed rehabilitation = 7, standard rehabilitation = 11). Five serious adverse events were reported. Conclusion: A main randomised controlled trial is feasible but would require allocation of participants following surgery to counter the issue of withdrawal due to not receiving surgery

Pragmatic randomised controlled trial to evaluate the effectiveness and cost effectiveness of a multi-component intervention to reduce substance use and risk-taking behaviour in adolescents involved in the criminal justice system: A trial protocol (RISKIT-CJS)

Abstract Background Adolescence is a critical developmental stage when young people make lifestyle choices that have the potential to impact on their current and future health and social wellbeing. The relationship between substance use and criminal activity is complex but there is clear evidence that the prevalence of problematic substance use is far higher among adolescent offenders than the general adolescent population. Adolescent offenders are a marginalized and vulnerable population who are significantly more likely to experience health and social inequalities in later life than their non-offending peers. There is a paucity of evidence on effective interventions to address substance use and risk-taking behaviours in adolescent offender populations but it is clear that preventative or abstinence orientated interventions are not effective. RISKIT-CJS is an intervention developed in collaboration with young people taking account of the current best evidence. Feasibility and pilot studies have found the intervention addresses the needs of adolescents, is acceptable and has demonstrated potential in reducing substance use and risk-taking behavior. Methods The study is a mixed method, two-armed, prospective, pragmatic randomized controlled trial with individual randomisation to either treatment as usual alone or the RISKIT-CJS intervention in addition to treatment as usual. Adolescents, aged 13 to 17 years inclusive, engaged with the criminal justice system who are identified as having problematic substance use are eligible to participate. The study will be conducted across three geographical areas; South and South East England, London and North East England between March 2017 and February 2019. Discussion The study represents an ambitious programme of work to address an area of need for a marginalized and vulnerable population. Trial registration ISRCTN77037777 registered 15/09/2016