Digital Training Program for Line Managers (Managing Minds at Work): Protocol for a Feasibility Pilot Cluster Randomized Controlled Trial.

BACKGROUND: Mental health problems affect 1 in 6 workers annually and are one of the leading causes of sickness absence, with stress, anxiety, and depression being responsible for half of all working days lost in the United Kingdom. Primary interventions with a preventative focus are widely acknowledged as the priority for workplace mental health interventions. Line managers hold a primary role in preventing poor mental health within the workplace and, therefore, need to be equipped with the skills and knowledge to effectively carry out this role. However, most previous intervention studies have directly focused on increasing line managers' understanding and awareness of mental health rather than giving them the skills and competencies to take a proactive preventative approach in how they manage and design work. The Managing Minds at Work (MMW) digital training intervention was collaboratively designed to address this gap. The intervention aims to increase line managers' knowledge and confidence in preventing work-related stress and promoting mental health at work. It consists of 5 modules providing evidence-based interactive content on looking after your mental health, designing and managing work to promote mental well-being, management competencies that prevent work-related stress, developing a psychologically safe workplace, and having conversations about mental health at work. OBJECTIVE: The primary aim of this study is to pilot and feasibility test MMW, a digital training intervention for line managers. METHODS: We use a cluster randomized controlled trial design consisting of 2 arms, the intervention arm and a 3-month waitlist control, in this multicenter feasibility pilot study. Line managers in the intervention arm will complete a baseline questionnaire at screening, immediately post intervention (approximately 6 weeks after baseline), and at 3- and 6-month follow-ups. Line managers in the control arm will complete an initial baseline questionnaire, repeated after 3 months on the waitlist. They will then be granted access to the MMW intervention, following which they will complete the questionnaire post intervention. The direct reports of the line managers in both arms of the trial will also be invited to take part by completing questionnaires at baseline and follow-up. As a feasibility pilot study, a formal sample size is not required. A minimum of 8 clusters (randomized into 2 groups of 4) will be sought to inform a future trial from work organizations of different types and sectors. RESULTS: Recruitment for the study closed in January 2022. Overall, 24 organizations and 224 line managers have been recruited. Data analysis was finished in August 2023. CONCLUSIONS: The results from this feasibility study will provide insight into the usability and acceptability of the MMW intervention and its potential for improving line manager outcomes and those of their direct reports. These results will inform the development of subsequent trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT05154019; https://clinicaltrials.gov/study/NCT05154019. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48758.

Strengthening Mental Abilities with Relational Training (SMART) in multiple sclerosis (MS): study protocol for a feasibility randomised controlled trial.

BACKGROUND: Multiple sclerosis (MS) is a chronic condition of the central nervous system, affecting around 1 in every 600 people in the UK, with 130 new diagnoses every week. Cognitive difficulties are common amongst people with MS, with up to 70% experiencing deficits in higher-level brain functions-such as planning and problem-solving, attention, and memory. Cognitive deficits make it difficult for people with MS to complete everyday tasks and limit their abilities to work, socialise, and live independently. There is a clear need-and recognised research priority-for treatments that can improve cognitive functioning in people with MS. The absence of effective cognitive interventions exacerbates burdens on the services accessed by people with MS-requiring these services to manage sequelae of untreated cognitive deficits, including reduced quality of life, greater disability and dependence, and poorer adherence to disease-modifying treatments. Our planned research will fill the evidence gap through developing-and examining the feasibility of trialling-a novel online cognitive rehabilitation programme for people with MS (SMART). The SMART programme directly trains relational skills (the ability to flexibly relate concepts to one another) based on theory that these skills are critical to broader cognitive functioning. METHODS: The primary objective of this study aims to conduct a feasibility study to inform the development of a definitive trial of SMART for improving cognitive functioning in people with MS. The secondary objective is to develop the framework for a cost-effectiveness analysis alongside a definitive trial, and the exploratory objective is to assess the signal of efficacy. DISCUSSION: As a feasibility trial, outcomes are unlikely to immediately effect changes to NHS practice. However, this is a necessary step towards developing a definitive trial-and will give us a signal of efficacy, a prerequisite for progression to a definitive trial. If found to be clinically and cost-effective, the latter trial could create a step-change in MS cognitive rehabilitation-improving service delivery and optimising support with limited additional resources. TRIAL REGISTRATION: Registration ID: ClnicalTrials.gov: NCT04975685-registered on July 23rd, 2021. PROTOCOL VERSION: 2.0, 25 November 2021.

Usability and acceptability of a cognitive training intervention (SMART) for people with multiple sclerosis (MS): A prefeasibility formative evaluation.

Background: Multiple sclerosis (MS) is a chronic autoimmune, inflammatory neurological disease of the central nervous system (CNS), increasing in incidence and prevalence across both developed and developing countries. Cognitive difficulties are common in MS sufferers with 70% experiencing difficulties in higher-level brain functioning such as planning, attention, problem solving, and memory. Computerised cognitive training programmes may hold promise as a treatment option for improving cognitive function in people with MS, subject to exploring and addressing potential barriers to usability and acceptability. Methods: This study aimed to test the usability and acceptability of a computerised cognitive training intervention-Strengthening Mental Abilities Through Relational Training (SMART) -for people with MS, through a mostly qualitative prefeasibility design ( n= 12). There were two phases of testing: (1) initial usability testing via a think-aloud protocol ( n= 6) and (2) alpha-testing to assess experienced acceptability over a four-week period of engagement ( n= 6). Data from the two phases were subjected to Framework Analysis, wherein we deductively applied the Health IT Usability Evaluation Model and Theoretical Framework of Acceptability to assess usability and acceptability, respectively. Results: Results show SMART to have satisfactory usability with participants reacting positively to the formatting, visuality, and process of the interface. Minor suggestions were made on how best to adapt SMART for people with MS, but the programme and facilitative support were generally perceived to be acceptable, with participants expressing positive feelings about taking part in the intervention, despite associated burdens. Conclusions: This prefeasibility study provides preliminary evidence of the usability and acceptability of SMART as a computerised cognitive training programme for people with MS. We conclude that we can now move forward with a feasibility trial of SMART, with the intention of proceeding to a definitive trial with cost-effectiveness analysis.

AIMS: We are developing a new 'brain training' treatment to help people with multiple sclerosis (MS) who have problems with thinking skills ( e.g., problem-solving, attention, and memory). This study aimed to test whether the training (called 'Strengthening Mental Abilities Through Relational Training' ['SMART']) is suitable for people with MS. Specifically, we assessed whether SMART was easy to use and acceptable for use in their everyday lives. BACKGROUND: MS is a long-term condition that affects the nervous system, with the number of cases increasing in both developed and developing countries. MS affects an individual's thinking skills, which can affect their ability to go about their everyday lives. Brain training has potential for improving thinking skills in people with MS, provided ease of use and factors impacting willingness to use the training are explored. Design and methods used: This study used a mix of methods, such as scores from objective tests and verbal feedback, to explore whether SMART is easy to use and acceptable for people with MS. The study had two phases: think-aloud interviews (participants provided feedback on whether the training interface and guidance were easy to use) and then the alpha-testing phase (participants tested the training over time, and then gave feedback on acceptability). Common and salient themes were identified in both phases. RESULTS: Participants found SMART to be suitably easy to use and acceptable for use by people with MS. Participants thought that the interface was visually appealing, and easy to operate and navigate. Participants made minor suggestions for improving the intervention, but feedback was generally positive, despite demands on time and energy. DISCUSSION: SMART appears to be suitable for people with MS. We conclude that we can go ahead with the next phase of testing SMART, as a possible treatment for improving thinking skills in people with MS.

The effect of explosive remnants of war on global public health: a systematic mixed-studies review using narrative synthesis.

BACKGROUND: Explosive remnants of war (ERW)-landmines, unexploded ordnance (UXO), and abandoned explosive ordnance (AXO)-have been recognised as a threat to health since the 1990s. We aimed to study the effect of ERW on global public health. METHODS: In this systematic mixed-studies review, we searched the Web of Science, Scopus, PubMed, and ProQuest databases, and hand searched relevant websites, for articles published between Jan 1, 1990, and Aug 31, 2015. We used keywords and Medical Subject Headings related to ERW, landmines, UXO, and AXO to locate original peer-reviewed quantitative, qualitative, or mixed-methods studies in English of the direct physical or psychological effects of ERW on direct victims of the explosive device or reverberating social and economic effects on direct victims and indirect victims (their families and the wider at-risk community). We excluded studies if more than 20% of participants were military, if they were of deminers, if they were from high-income countries, or if they were of chemical weapons. We identified no peer-reviewed studies of AXO effects, so we extended the search to include grey literature. We critically appraised study quality using a mixed methods appraisal tool. We used a narrative synthesis approach to categorise and synthesise the literature. We extracted quantitative data and calculated means and percentages. FINDINGS: The initial search identified 10 226 studies, leaving 8378 (82%) after removal of duplicates, of which we reviewed 54 (26 [48%] were quantitative descriptive studies, 20 [37%] were quantitative non-randomised studies, four [7%] were mixed-methods studies, and four [7%] were grey literature). The direct psychological effects of landmines or UXO appear high. We identified comorbidity of anxiety and depression in landmine or UXO victims in four studies, more women presented with post-traumatic stress disorder than did men in two studies, and landmine or UXO victims reported a greater prevalence of post-traumatic stress disorder, anxiety, or depression than did control groups in two studies. Overall injury and mortality rates caused by landmines or UXO decreased over time across five studies and increased in one. More men were injured or killed by landmines or UXO than were women (0-30·6% of women), the mean ages of casualties ranged from 18·5 years to 38·1 years, and victims were likely to be doing an activity of economic necessity at the time of injury. The proportion of casualties of landmines or UXO younger than 18 years ranged from 22% to 55% across twelve studies. Landmine or UXO victims who had one or more limbs amputated ranged from 19·5% to 82·6%. Landmines and UXO had a negative effect on internally displaced populations and returning refugees, physical security, economic productivity, child health and educational attainment, food security, and agriculture in studies from seven countries. We could not establish the proportion of casualties caused by AXO from unplanned explosions at munitions sites, although the grey literature suggests that AXO is a substantial problem. INTERPRETATION: Individually, these landmine and UXO results are not new and substantiate findings from existing research. Taken together, however, these findings provide a picture of the effect of landmines and UXO that stretches far beyond injury and mortality prevalence, making landmine and UXO clearance a more favourable option for funders. AXO effects are understudied and warrant further research. FUNDING: King's College London.

Limitations of body mass index for counseling individuals with unilateral lower extremity amputation.

BACKGROUND: Body composition is important for health screening, but appropriate methods for unilateral lower extremity amputees have not been validated. OBJECTIVES: To compare body mass index adjusted using Amputee Coalition equations (body mass index-Amputee Coalition) to dual-energy X-ray absorptiometry in unilateral lower limb amputees. STUDY DESIGN: Cross-sectional, experimental. METHODS: Thirty-eight men and women with lower limb amputations (transfemoral, transtibial, hip disarticulation, Symes) participated. Body mass index (mass/height2) was compared to body mass index corrected for limb loss (body mass index-Amputee Coalition). Accuracy of classification and extrapolation of percent body fat with body mass index was compared to dual-energy X-ray absorptiometry. RESULTS: Body mass index-Amputee Coalition increased body mass index (by ~ 1.1 kg/m2) but underestimated and mis-classified 60% of obese and overestimated 100% of lean individuals according to dual-energy X-ray absorptiometry. Estimated mean percent body fat (95% confidence interval) from body mass index-Amputee Coalition (28.3% (24.9%, 31.7%)) was similar to dual-energy X-ray absorptiometry percent body fat (29.5% (25.2%, 33.7%)) but both were significantly higher ( p < 0.05) than percent body fat estimated from uncorrected body mass index (23.6% (20.4%, 26.8%)). However, total errors for body mass index and body mass index-Amputee Coalition converted to percent body fat were unacceptably large (standard error of the estimate = 6.8%, 6.2% body fat) and the discrepancy between both methods and dual-energy X-ray absorptiometry was inversely related ( r = -0.59 and r = -0.66, p < 0.05) to the individual's level of body fatness. CONCLUSIONS: Body mass index (despite correction) underestimates health risk for obese patients and overestimates lean, muscular individuals with lower limb amputation. Clinical relevance Clinical recommendations for an ideal body mass based on body mass index-Amputee Coalition should not be relied upon in lower extremity amputees. This is of particular concern for obese lower extremity amputees whose health risk might be significantly underestimated based on body mass index despite a "correction" formula for limb loss.

An assessment of the barriers to accessing the Basic Package of Health Services (BPHS) in Afghanistan: was the BPHS a success?

Afghanistan is one of the most fragile and conflict-affected countries in the world. It has experienced almost uninterrupted conflict for the last thirty years, with the present conflict now lasting over a decade. With no history of a functioning healthcare system, the creation of the Basic Package of Health Services (BPHS) in 2003 was a response to Afghanistan's dire health needs following decades of war. Its objective was to provide a bare minimum of essential health services, which could be scaled up rapidly through contracting mechanisms with Non-Governmental Organisations (NGOs). The central thesis of this article is that, despite the good intentions of the BPHS, not enough has been done to overcome the barriers to accessing its services. This analysis, enabled through a review of the existing literature, identifies and categorises these barriers into the three access dimensions of: acceptability, affordability and availability. As each of these is explored individually, analysis will show the extent to which these barriers to access are a critical issue, consider the underlying reasons for their existence and evaluate the efforts to overcome these barriers. Understanding these barriers and the policies that have been implemented to address them is critical to the future of health system strengthening in Afghanistan.

Older soft tissue sarcoma patients experience increased rates of venous thromboembolic events: a retrospective cohort study of SEER-Medicare data.

BACKGROUND: Venous thromboembolic co-morbidities can have a significant impact on treatment response, treatment options, quality of life, and ultimately, survival from cancer. There is a dearth of published information on venous thromboembolic co-morbidity among older soft tissue sarcoma patients. METHODS: SEER-Medicare linked data (1993-2005) was utilized for this retrospective cohort analysis (n = 3,480 soft tissue sarcoma patients). Non-cancer patients were frequency-matched by age to cancer patients at a ratio of 1:1; coverage and follow-up requirements were the same as for soft tissue sarcoma cases. Venous thromboembolic events were divided into three groups of interest: deep vein thrombosis, pulmonary embolism, and other thromboembolic events. Relative incidence rates of venous thromboembolic events in soft tissue sarcoma patients with a recent history of cardiovascular event or venous thromboembolic event (12 months before diagnosis) versus soft tissue sarcoma patients without such a recent history were calculated using the Cox proportional hazard models. The Cox proportional hazard model was used to build predictive models to identify important risk factors for each venous thromboembolic event of interest among soft tissue sarcoma patients. Relative incidence rate of VTEs in cancer patients (12 months after diagnosis) versus non-cancer cases (12 months after index date) was calculated using multivariable Cox proportional hazard models. RESULTS: We observed that among older soft tissue sarcoma patients, 10.6% experienced a deep vein thrombosis, 3.0% experienced a pulmonary embolism, and 3.1% experienced other thromboembolic events in the 12 months after sarcoma diagnosis. On average, 60% of venous thromboembolic events occurred in the first 90 days after sarcoma diagnosis. The highest rates of deep vein thrombosis and pulmonary embolism after sarcoma diagnosis were seen in patients with sarcoma not otherwise specified (deep vein thrombosis: 204/1,000 p-y and pulmonary embolism: 50/1,000 p-y). Recent history of a venous thromboembolic event was the strongest predictor of a subsequent venous thromboembolic event after soft tissue sarcoma diagnosis. CONCLUSION: Venous thromboembolic events are common and serious co-morbidities that should be closely monitored in older soft tissue sarcoma patients.

Older renal cell cancer patients experience increased rates of venous thromboembolic events: a retrospective cohort study of SEER-Medicare data.

BACKGROUND: Venous thromboembolic co-morbidities can have a significant impact on treatment response, treatment options, quality of life, and ultimately, survival from cancer. The extent of venous thromboembolic co-morbidity among older renal cell cancer patients is poorly described in the literature. It is important to understand the scope of venous thromboembolic events, before and after diagnosis, in order to offer renal cell cancer patients optimal care and improved quality of life. METHODS: The main goal of this study was to estimate and describe the incidence of venous thromboembolic events before and after renal cell cancer diagnosis. SEER-Medicare linked data (1991-2003) was utilized for this retrospective cohort analysis (n = 11,950) of older renal cell cancer patients (≥ 65 years). Incidence rates and proportions in addition to multivariable Cox proportional hazard and logistic regression models were utilized to describe the incidence and relative risk of venous thromboembolic events. RESULTS: We observed that in the 12 months after diagnosis, 8.3% of renal cell cancer patients experienced a deep venous thrombosis, 2.4% experienced a pulmonary embolism, and 3.9% experienced other thromboembolic events. Nearly 70% of venous thromboembolic events occurred in the first 90 days after renal cell cancer diagnosis. Renal cell cancer patients were 2-4 times more likely to have a venous thromboembolic event in the 12 months after cancer diagnosis than non-cancer patients followed during the same time frame. Recent history of a venous event substantially increased the risk of that same event in the 12 months after diagnosis (HR = 5.2-18.8). CONCLUSION: Venous thromboembolic events are common and serious co-morbidities that should be closely monitored in older renal cell cancer patients, particularly during the first 3 months following diagnosis and among those with a recent history of a venous thromboembolic event.

Selenium, folate, and colon cancer.

Selenium is an essential trace element that has been implicated in cancer risk; however, study results have been inconsistent with regard to colon cancer. Our objectives were to 1) investigate the association between selenium and colon cancer, 2) evaluate possible effect measure modifiers, and 3) evaluate potential biases associated with the use of postdiagnostic serum selenium measures. The North Carolina Colon Cancer Study is a large population-based, case-control study of colon cancer in North Carolina between 1996 and 2000 (n = 1,691). Nurses interviewed patients about diet and lifestyle and drew blood specimens, which were used to measure serum selenium. Individuals who had both high serum selenium (> 140 mcg/l) and high reported folate (> 354 mcg/day) had a reduced relative risk of colon cancer [odds ratio (OR) = 0.5, 95% confidence interval (CI) = 0.4-0.8). The risk of colon cancer for those with high selenium and low folate was approximately equal to the risk among those with low selenium and low folate (OR = 1.1, 95% CI = 0.7-1.5) as was the risk for those with low selenium and high folate (OR = 0.9, 95% CI = 0.7-1.2). We did not find evidence of bias due to weight loss, stage at diagnosis, or time from diagnosis to selenium measurement. High levels of serum selenium and reported folate jointly were associated with a substantially reduced risk of colon cancer. Folate status should be taken into account when evaluating the relation between selenium and colon cancer in future studies. Importantly, weight loss, stage at diagnosis, or time from diagnosis to blood draw did not appear to produce strong bias in our study.

Selenium, apoptosis, and colorectal adenomas.

BACKGROUND: Selenium is an essential trace element found in cereals, wheat, dairy products, meat, and fish. This micronutrient may prevent carcinogenesis through several biochemical pathways; one suggested pathway is enhanced apoptosis. OBJECTIVES: The relation between selenium and colorectal adenomas was evaluated because the colorectal adenoma is the established precursor lesion of most colorectal cancers. Apoptosis was a pathway of interest because decreased apoptosis has been associated with an increased prevalence of adenomas. Our objectives were as follows: to investigate the association between (a) selenium and colorectal adenomas and (b) selenium and apoptosis. METHODS: The study population was assembled for the Diet and Health Study III (n = 803), a cross-sectional study conducted at the University of North Carolina Hospital (Chapel Hill, NC). There were 451 participants in the analysis of selenium and adenoma prevalence and 351 participants in the analysis of selenium and apoptosis. Selenium was measured from serum collected at the time of colonoscopy. Apoptosis was measured in biopsies from normal rectal epithelium obtained during the colonoscopy procedure. RESULTS: Participants in the highest fifth of serum selenium were less likely to have adenomas in comparison with those in the lowest fifth (prevalence ratio, 0.6; 95% confidence interval, 0.4-1.1). Selenium and apoptosis (>2.76 cells per crypt) were not strongly related, but results collectively suggested a roughly inverse association. CONCLUSIONS: High selenium was associated with a reduced prevalence of colorectal adenomas. Apoptosis, however, did not seem to be the mechanism by which selenium was related to adenoma prevalence in our data.

Does physical activity modify the association between body mass index and colorectal adenomas?

Although both physical inactivity and obesity have been associated with an increased risk of colorectal adenomas, it is unclear whether physical activity modifies the relationship between obesity and colorectal adenomas or through what mechanism this might occur. The aim of this study is to evaluate whether physical activity modifies the relationship between body mass index (BMI) and colorectal adenomas and whether apoptosis is a plausible mechanism responsible for this effect modification. Study subjects were part of a large, cross-sectional study, the Diet and Health Study III. Consecutive patients underwent colonoscopy between August 1998 and March 2000. Apoptosis was measured by morphological evaluation of hematoxylin and eosin-stained sections obtained from rectal pinch biopsy samples. There were 226 patients with adenomas and 494 adenoma-free controls. When comparing overweight subjects with the referent group (high physical activity/normal BMI), the relative odds of having an adenoma decreased as physical activity increased: low (odds ratio, OR=1.6; 95% confidence interval, CI=0.7-3.4); moderate (OR=1.1; 95% CI=0.6-2.0); and high (OR=0.8; 95% CI=0.4-1.6). When comparing obese subjects with the referent group, relative odds of having an adenoma were increased regardless of physical activity level. Apoptosis was not associated with obesity or physical activity. Our results suggest that physical activity may modify the association between obesity and colorectal adenoma until a high level of obesity is achieved. Apoptosis does not appear to be associated with obesity or physical activity.