Physical activity and sedentary behaviour of Bahraini people with type 2 diabetes: A cross-sectional study.

Objective: Study patterns of physical activity and sedentary behaviour and the influence of demographics and body mass index (BMI) on these behaviours amongst Bahraini adults with type 2 diabetes over 10 weeks using an activity tracker. Method: This cross-sectional observational study was conducted at a Bahrain government health centre. Thirty-three Bahraini Arab adults, 30-60 years old, with controlled type 2 diabetes, wore a Fitbit Flex 2TM activity tracker for 10 weeks. Data on age, sex, marital and employment status, education and BMI were collected at the start of the study. Results: A total of N = 32 participants completed the study. The average steps per day were 7859 ± 4131, and there were no differences between baseline, week 5 and 10. A third of participants were sedentary, based on a threshold of 5000 steps/day. Females accumulated fewer average daily steps than males (6728 ± 2936 vs. 10,281 ± 4623, p = 0.018). Daily averages for physical activity intensity were as follows: sedentary (786 ± 109 min), light (250 ± 76 min), moderate (9 ± 10 min) and vigorous (12 ± 18 min). Males had higher daily averages versus females for moderate (13 ± 9 vs. 5 ± 9 min, p = 0.018) and vigorous physical activity (21 ± 23 vs. 5 ± 7 min, p = 0.034). 91% of participants wore the device ≥10 h/day. The adherence rate was 79% based on percentage of days the device was worn continuously over 10 weeks. Conclusion: Future physical activity interventions should target sedentary and female participants with type 2 diabetes. In addition, we need to understand the facilitators and barriers to physical activity and the physical activity preferences of these two subgroups.

Psychological interventions for women with non-metastatic breast cancer.

BACKGROUND: Breast cancer is the most common cancer affecting women worldwide. It is a distressing diagnosis and, as a result, considerable research has examined the psychological sequelae of being diagnosed and treated for breast cancer. Breast cancer is associated with increased rates of depression and anxiety and reduced quality of life. As a consequence, multiple studies have explored the impact of psychological interventions on the psychological distress experienced after a diagnosis of breast cancer. This review is an update of a Cochrane Review first published in 2015. OBJECTIVES: To assess the effect of psychological interventions on psychological morbidities and quality of life among women with non-metastatic breast cancer.  SEARCH METHODS: We searched the Cochrane Breast Cancer Group Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov up to 16 March 2021. We also scanned the reference lists of relevant articles. SELECTION CRITERIA: Randomised controlled trials that assessed the effectiveness of psychological interventions for women with non-metastatic breast cancer. DATA COLLECTION AND ANALYSIS: Two review authors independently appraised, extracted data from eligible trials, and assessed risk of bias and certainty of the evidence using the GRADE approach. Any disagreement was resolved by discussion. Extracted data included information about participants, methods, the intervention and outcomes. MAIN RESULTS: We included 60 randomised controlled trials comprising 7998 participants. The most frequent reasons for exclusion were non-randomised trials and the inclusion of women with metastatic disease. The updated review included 7998 randomised women; the original review included 3940 women. A wide range of interventions was evaluated. Most interventions were cognitive- or mindfulness-based, supportive-expressive, and educational. The interventions were mainly delivered face-to-face (56 studies) and in groups (50 studies) rather than individually (10 studies). Most intervention sessions were delivered on a weekly basis with an average duration of 14 hours. Follow-up time ranged from two weeks to 24 months.  Pooled standardised mean differences (SMD) from baseline indicated that the intervention may reduce depression (SMD -0.27, 95% confidence interval (CI) -0.52 to -0.02; P = 0.04; 27 studies, 3321 participants, I2 = 91%, low-certainty evidence); anxiety (SMD -0.43, 95% CI -0.68 to -0.17; P = 0.0009; 22 studies, 2702 participants, I2 = 89%, low-certainty evidence); mood disturbance in the intervention group (SMD -0.18, 95% CI -0.31 to -0.04; P = 0.009; 13 studies, 2276 participants, I2 = 56%, low-certainty evidence); and stress (SMD -0.34, 95% (CI) -0.55 to -0.12; P = 0.002; 8 studies, 564 participants, I2 = 31%, low-certainty evidence). The intervention is likely to improve quality of life in the intervention group (SMD 0.78, 95% (CI) 0.32 to 1.24; P = 0.0008; 20 studies, 1747 participants, I2 = 95%, low-certainty evidence). Adverse events were not reported in any of the included studies. AUTHORS' CONCLUSIONS: Based on the available evidence, psychological intervention may have produced favourable effects on psychological outcomes, in particular depression, anxiety, mood disturbance and stress. There was also an improvement in quality of life in the psychological intervention group compared to control group. Overall, there was substantial variation across the studies in the range of psychological interventions used, control conditions, measures of the same outcome and timing of follow-up.

Assessing medical mistrust in organ donation across countries using item response theory.

Although medical mistrust (MM) may be an impediment to public health interventions, no MM scale has been validated across countries and the assessment of MM has not been explored using item response theory, which allows generalisation beyond the sampled data. We aimed to determine the dimensionality of a brief MM measure across four countries through Mokken analysis and Graded Response Modelling. Analysis of 1468 participants from UK (n = 1179), Ireland (n = 191), India (n = 49) and Malaysia (n = 49) demonstrated that MM items formed a hierarchical, unidimensional measure, which is very informative about high levels of MM. Possible item reduction and scoring changes were also demonstrated. This study demonstrates that this brief MM measure is suitable for international studies as it is unidimensional across countries, cross cultural, and shows that minor adjustments will not impact on the assessment of MM when using these items.

Vaccine trials during a pandemic: potential approaches to ethical dilemmas.

Ever since the emergence of the coronavirus disease 2019 (COVID-19), global public health infrastructures and systems, along with community-wide collaboration and service, have risen to an unprecedented challenge. Vaccine development was immediately propelled to the centre of all our scientific, public health and community efforts. Despite the development of SARS-CoV-2 vaccines arguably being the greatest and most palpable achievements of the past 12 months, they have also been one of the most contentious and debated issues during the pandemic. However, what uniquely differentiates vaccine development is its intimate relationship with the community it seeks to serve; both in its clinical trial testing as an efficacious and safe prophylactic, and its post-developmental 'roll-out' success, as an effective public health tool. These relationships have birthed a myriad of complexities, from community-based mistrust, to academically contended ethical dilemmas. Indeed, the accelerated advances in the COVID-19 vaccine race have further exacerbated this phenomenon, bringing with it new ethical dilemmas that need to be examined to ensure the continued clinical success of these therapeutics and a renewed societal trust in clinical medicine.In this paper, we discuss two major ethical dilemmas: (1) the equipoise of continuing new vaccine trials in the advent of successful candidates and (2) the maleficence of blinded placebo arms. Accordingly, we discuss six different potential approaches to these ethical dilemmas: (1) continuing with placebo-controlled trials, (2) transitioning from placebo-controlled to open-label, (3) unblinding at-risk priority groups only, (4) transitioning to a blinded stepped-wedge cross-over design, (5) progressing to a blinded active-controlled stepped-wedge cross-over trial, and (6) conducting randomised stepped-wedge community trials. We also propose a decision-making algorithm for relevant stakeholders in advanced stages of vaccine trials.It is important to remember that the emergent nature of the COVID-19 situation does not justify a compromise on core ethical values. In fact, the discourse surrounding this topic and the decisions made will remain a potent case study and a continuously referenced example for all such future scenarios.

Theory Content, Question-Behavior Effects, or Form of Delivery Effects for Intention to Become an Organ Donor? Two Randomized Trials.

Eliciting different attitudes with survey questionnaires may impact on intention to donate organs. Previous research used varying numbers of questionnaire items, or different modes of intervention delivery, when comparing groups. We aimed to determine whether intention to donate organs differed among groups exposed to different theoretical content, but similar questionnaire length, in different countries. We tested the effect of excluding affective attitudinal items on intention to donate, using constant item numbers in two modes of intervention delivery. Study 1: A multi-country, interviewer-led, cross-sectional randomized trial recruited 1007 participants, who completed questionnaires as per group assignment: including all affective attitude items, affective attitude items replaced, negatively-worded affective attitude items replaced. Study 2 recruited a UK-representative, cross-sectional sample of 616 participants using an online methodology, randomly assigned to the same conditions. Multilevel models assessed effects of group membership on outcomes: intention to donate (primary), taking a donor card, following a web-link (secondary). In study 1, intention to donate did not differ among groups. Study 2 found a small, significantly higher intention to donate in the negatively-worded affective attitudes replaced group. Combining data yielded no group differences. No differences were seen for secondary outcomes. Ancillary analyses suggest significant interviewer effects. Contrary to previous research, theoretical content may be less relevant than number or valence of questionnaire items, or form of intervention delivery, for increasing intention to donate organs.

Doctors don't Do-little: a national cross-sectional study of workplace well-being of hospital doctors in Ireland.

OBJECTIVES: To measure levels of occupational stress, burn-out, work-life balance, presenteeism, work ability (balance between work and personal resources) and desire to practise in trainee and consultant hospital doctors in Ireland. DESIGN: National cross-sectional study of randomised sample of hospital doctors. Participants provided sociodemographic data (age, sex), work grade (consultant, higher/basic specialist trainee), specialty, work hours and completed workplace well-being questionnaires (Effort-Reward Imbalance (ERI) Scale, overcommitment, Maslach Burnout Inventory) and single item measures of work ability, presenteeism, work-life balance and desire to practise. SETTING: Irish publicly funded hospitals and residential institutions. PARTICIPANTS: 1749 doctors (response rate of 55%). All hospital specialties were represented except radiology. RESULTS: 29% of respondents had insufficient work ability and there was no sex, age or grade difference. 70.6% reported strong or very strong desire to practise medicine, 22% reported good work-life balance, 82% experienced workplace stress, with effort greatly exceeding reward, exacerbated by overcommitment. Burn-out was evident in 29.7% and was significantly associated with male sex, younger age, lower years of practice, lower desire to practise, lower work ability, higher ERI ratio and greater overcommitment. Apart from the measures of work ability and overcommitment, there was no sex or age difference across any variable. However, ERI and burn-out were significantly lower in consultants than trainees. CONCLUSIONS: Hospital doctors across all grades in Ireland had insufficient work ability, low levels of work-life balance, high levels of work stress and almost one-third experienced burn-out indicating suboptimal work conditions and environment. Yet, most had high desire to practise medicine. Measurement of these indices should become a quality indicator for hospitals and research should focus on the efficacy of a range of individual and organisational interventions for burn-out and occupational stress.

The Role of Physical Activity Prescription in Cardiovascular Disease Prevention Amongst South Asian Canadians.

Unequivocal evidence suggests an increased prevalence of cardiovascular disease (CVD) amongst South Asian Canadians (SACs) compared to other ethnic cohorts, due to a combination of their unique cardiometabolic profile and environmental factors. This unfavorable CVD profile is characterized by an elevated risk of dyslipidemia, high apolipoprotein B/apolipoprotein A1 ratio, hypertension, glucose intolerance, type 2 diabetes mellitus, as well as increased BMI, body fat percentage, abdominal and visceral adiposity. Despite the overwhelming evidence for the effectiveness of physical activity (PA) in circumventing the onset of CVD and in the reduction of CVD risk factors, SACs are among the most physically inactive cohorts in Canada. This relates to a set of common and unique socio-cultural barriers, such as gender, beliefs and perceptions about illness, immigration, unfavorable PA environments, and their high prevalence of debilitating chronic diseases. Several strategies to improve PA participation rates in this high-risk population have been suggested, and include the implementation of culturally sensitive PA interventions, as well as clinician training in PA prescription through workshops that emphasize knowledge translation into clinical practice. Therefore, the purpose of this mini-review is to highlight and discuss: (1) the burden of heart disease in SACs (2) the cardiovascular benefits of PA for SACs; (3) factors affecting PA participation among SACs and how they can be addressed; (4) the impact of culturally sensitive PA prescription on CVD prevention; (5) barriers to culture-specific PA prescription by clinicians, and strategies to improve its use and impact.

Efficacy and cost-effectiveness of nurse-led care involving education and engagement of patients and a treat-to-target urate-lowering strategy versus usual care for gout: a randomised controlled trial.

BACKGROUND: In the UK, gout management is suboptimum, with only 40% of patients receiving urate-lowering therapy, usually without titration to achieve a target serum urate concentration. Nurses successfully manage many diseases in primary care. We compared nurse-led gout care to usual care led by general practitioners (GPs) for people in the community. METHODS: Research nurses were trained in best practice management of gout, including providing individualised information and engaging patients in shared decision making. Adults who had experienced a gout flare in the previous 12 months were randomly assigned 1:1 to receive nurse-led care or continue with GP-led usual care. We assessed patients at baseline and after 1 and 2 years. The primary outcome was the percentage of participants who achieved serum urate concentrations less than 360 µmol/L (6 mg/dL) at 2 years. Secondary outcomes were flare frequency in year 2, presence of tophi, quality of life, and cost per quality-adjusted life-year (QALY) gained. Risk ratios (RRs) and 95% CIs were calculated based on intention to treat with multiple imputation. This study is registered with www.ClinicalTrials.gov, number NCT01477346. FINDINGS: 517 patients were enrolled, of whom 255 were assigned nurse-led care and 262 usual care. Nurse-led care was associated with high uptake of and adherence to urate-lowering therapy. More patients receiving nurse-led care had serum urate concentrations less than 360 µmol/L at 2 years than those receiving usual care (95% vs 30%, RR 3·18, 95% CI 2·42-4·18, p<0·0001). At 2 years all secondary outcomes favoured the nurse-led group. The cost per QALY gained for the nurse-led intervention was £5066 at 2 years. INTERPRETATION: Nurse-led gout care is efficacious and cost-effective compared with usual care. Our findings illustrate the benefits of educating and engaging patients in gout management and reaffirm the importance of a treat-to-target urate-lowering treatment strategy to improve patient-centred outcomes. FUNDING: Arthritis Research UK.

The CHARMS pilot study: a multi-method assessment of the feasibility of a sexual counselling implementation intervention in cardiac rehabilitation in Ireland.

BACKGROUND: Many people living with cardiovascular disease (CVD) are affected by sexual problems associated with the condition. International guidelines recommend all patients with CVD should receive sexual counselling, yet this is rarely provided by health professionals. The current study piloted the Cardiac Health and Relationship Management and Sexuality (CHARMS) intervention, a complex multi-level intervention designed to increase the implementation of sexual counselling guidelines in hospital-based cardiac rehabilitation (CR) in Ireland. METHODS: The CHARMS intervention, consisting of awareness training and skills development for staff, and education and support for patients, was implemented in two CR centres. Following a repeated measures design, quantitative and qualitative feasibility, fidelity, cost, and outcome data were collected from staff and patients at baseline (T1, pre-intervention), at 3 months post-baseline (T2, post-intervention), and at 6 months post-baseline (T3, post-intervention). Data were organised according to a 14-point reporting framework of methodological issues that should be examined in pilot and feasibility studies. To inform a future definitive trial, potential solutions to identified feasibility issues were generated using the ADePT process for decision-making after pilot and feasibility trials. RESULTS: Most elements of the study protocol were executed smoothly, and intervention implementation was successful. Patients' (N = 42) responses to the intervention were positive. The reporting framework and the ADePT process facilitated the identification of two overarching feasibility problems, as well as solutions to be implemented in a definitive trial: (1) a high level of patient attrition in the pilot study, to be addressed through the use of financial incentives, reducing the length of the patient questionnaire, and providing a telephone survey option; and (2) negative staff perceptions, to be addressed through an augmented staff intervention, reframing 'sexual counselling' as 'sexual education and support' to fit with professional role perceptions, and reviewing all intervention terminology with a CR staff member to ensure acceptability. CONCLUSIONS: This article reports the successful piloting of a novel sexual counselling implementation intervention in cardiac rehabilitation. The utilisation of an extended reporting framework and the ADePT process facilitated the identification of adaptations necessary to ensure the feasibility of a definitive trial, thereby maximising methodological transparency.

Synergistic effects of brain-derived neurotrophic factor (BDNF) and exercise intensity on memory in the adolescent brain: a commentary.

This commentary highlights the recently published study by Jeon and Ha (Environ Health Prev Med 22:27, 2017) examining the effects of exercise intensity and brain-derived neurotrophic factor (BDNF) on memory in adolescents. This 12-week training study elicited increases in BDNF and improvements in working memory during moderate- and high-intensity exercise, which may have been achieved through improved brain tissue oxygenation, nutrient delivery, and BDNF mRNA expression. These improvements highlight the positive neuroendocrinological effects of BDNF and its role as a potential candidate molecule, as a mediator of synaptic plasticity. In this commentary, we aim to highlight the strengths and potential areas of consideration of Jeon and Ha (Environ Health Prev Med 22:27, 2017). We also offer insight into the clinical implications of this study, such as advocating for exercise in healthy children and as adjunctive therapy in pathological states. This study is promising and further highlights the importance of cardiorespiratory exercise in improving physiological health and cognitive functioning in youth through the phenomenon of neuroplasticity.

Participants' Experiences of a Sexual Counseling Intervention During Cardiac Rehabilitation: A Nested Qualitative Study Within the CHARMS Pilot Randomized Controlled Trial.

BACKGROUND: International guidelines recommend sexual assessment and counseling be offered to all patients with cardiovascular disease during cardiac rehabilitation. However, sexual problems are infrequently addressed. The Cardiac Health and Relationship Management and Sexuality (CHARMS) intervention is a complex, multilevel intervention designed to increase the provision of sexual counseling in cardiac rehabilitation. It was piloted in 2 cardiac rehabilitation centers to assess the acceptability and feasibility of the intervention and to inform and refine a definitive cluster randomized controlled trial protocol. OBJECTIVES: The aim of this study was to explore the experiences, perceptions, and opinions of patients, partners, and cardiac rehabilitation staff who participated in the CHARMS staff-led patient education class. METHODS: A qualitative, descriptive study using semistructured interviews to collect the data. Cardiac rehabilitation staff (n = 8) were interviewed when the intervention commenced in their center and 3 months later (n = 6). Patients (n = 19) and partners (n = 2) were interviewed after delivery of the class; 7 were interviewed again 3 months postintervention to explore temporal changes in opinions. RESULTS: Most cardiac rehabilitation staff were comfortable delivering the CHARMS intervention but would prefer a less structured format. Some staff perceived discomfort among patients. Few patients reported discomfort. Most patients and partners considered that the intervention was a welcome and acceptable part of a cardiac rehabilitation program. CONCLUSION: Incorporating sexual counseling into cardiac rehabilitation programs is feasible. Although the views of the patients and staff diverged on a number of issues including the perceived comfort of patients, its inclusion was welcomed by patients and was acceptable overall to both staff and patients.

What's up doc? A national cross-sectional study of psychological wellbeing of hospital doctors in Ireland.

OBJECTIVES: To measure levels of psychological distress, psychological wellbeing and self-stigma in hospital doctors in Ireland. DESIGN: National cross-sectional study of randomised sample of hospital doctors. Participants provided sociodemographic data (age, sex, marital status), work grade (consultant, higher/basic specialist trainee), specialty and work hours and completed well-being questionnaires (the Depression Anxiety Stress Scale, WHO Well-being Index, General Health Questionnaire) and single-item scales on self-rated health and self-stigma. SETTING: Irish publicly funded hospitals and residential institutions. PARTICIPANTS: 1749 doctors (response rate of 55%). All hospital specialties were represented except radiology. RESULTS: Half of participants were men (50.5%). Mean hours worked per week were 57 hours. Over half (52%) rated their health as very good/excellent, while 50.5% reported positive subjective well-being (WHO-5). Over a third (35%) experienced psychological distress (General Health Questionnaire 12). Severe/extremely severe symptoms of depression, anxiety and stress were evident in 7.2%, 6.1% and 9.5% of participants (Depression, Anxiety, Stress Scale 21). Symptoms of distress, depression, anxiety and stress were significantly higher and levels of well-being were significantly lower in trainees compared with consultants, and this was not accounted for by differences in sociodemographic variables. Self-stigma was present in 68.4%. CONCLUSIONS: The work hours of doctors working in Irish hospitals were in excess of European Working Time Directive's requirements. Just over half of hospital doctors in Ireland had positive well-being. Compared with international evidence, they had higher levels of psychological distress but slightly lower symptoms of depression and anxiety. Two-thirds of respondents reported self-stigma, which is likely to be a barrier to accessing care. These findings have implications for the design of support services for doctors, for discussions on quality of patient care and for future research.

Circumventing the "Ick" Factor: A Randomized Trial of the Effects of Omitting Affective Attitudes Questions to Increase Intention to Become an Organ Donor.

Objectives: Including or excluding certain questions about organ donation may influence peoples' intention to donate. We investigated the effect of omitting certain affective attitudinal items on potential donors' intention and behavior for donation. Design: A cross-sectional survey with a subgroup nested randomized trial. Methods: A total of 578 members of the public in four shopping centers were surveyed on their attitudes to organ donation. Non-donors (n = 349) were randomly assigned to one of three groups: Group 1 completed items on affective and cognitive attitudes, anticipated regret, intention, subjective norm and perceived behavioral control. Group 2 completed all items above but excluded affective attitudes. Group 3 completed all items but omitted negatively worded affective attitudes. The primary outcome was intention to donate, taking a donor card after the interview was a secondary behavioral outcome, and both were predicted using linear and logistic regression with group 1 as the reference. Results: Mean (SD) 1-7 intention scores for groups 1, 2 and 3 were, respectively: 4.43 (SD 1.89), 4.95 (SD 1.64) and 4.88 (SD 1.81), with group 2 significantly higher than group 1 (ß = 0.518, 95% confidence interval [CI] 0.18 to 0.86).At the end of the interview, people in group 2 (66.7%; OR = 1.40, 95% CI 0.94 to 2.07, p = 0.096) but not those in group 3 (61.7%; OR = 1.10, 95% CI 0.69 to 1.75, p = 0.685), were marginally more likely to accept a donor card from the interviewer than people in group 1 (59.7%). Conclusion: Omitting affective attitudinal items results in higher intention to donate organs and marginally higher rates of acceptance of donor cards, which has important implications for future organ donation public health campaigns.

Association Between Sexual Problems and Relationship Satisfaction Among People With Cardiovascular Disease.

BACKGROUND: Relationship satisfaction is generally positively correlated with sexual satisfaction, but this relation has been poorly examined in people with cardiovascular disease who are at increased risk of sexual problems compared with the general population. AIM: To document reported changes to sex after a diagnosis of cardiac disease and determine whether there is an association between sexual function and relationship satisfaction. METHODS: Semistructured telephone interviews focused on relationship satisfaction and sexual problems were conducted with 201 people with cardiovascular disease who were currently in a sexual relationship with one main partner and were recruited from six hospital cardiac rehabilitation centers in Ireland. Comparisons between groups were conducted using t-tests and multivariate analysis of variance for continuous variables and χ2 tests for categorical variables. Predictors of relationship satisfaction were assessed using multiple linear regression analysis. OUTCOMES: Data were gathered on demographic and clinical variables, sexual problems, and relationship satisfaction, including satisfaction with the physical, emotional, affection, and communication aspects of relationships. RESULTS: Just less than one third of participants (n = 61, 30.3%) reported that sex had changed for the worse since their cardiac event or diagnosis, with approximately half of these stating that this was a serious problem for them. Satisfaction with relationships was high among patients surveyed; more than 70% of the sample reported being very or extremely satisfied with the physical and emotional aspects and showing affection during sex. Satisfaction with communication about sex was lower, with only 58% reporting being very or extremely satisfied. We did not find significant associations between reporting of sexual problems or deterioration of sex as a result of disease and relationship satisfaction. CLINICAL IMPLICATIONS: Cardiac rehabilitation programs should address these sexual problems, potentially by enhancing communication within couples about sex. STRENGTHS AND LIMITATIONS: The strength is that data are presented on the sexual experiences and relationship satisfaction of a relatively large sample of people diagnosed with cardiac disease, a relatively underexplored research area. Limitations include the possibility of selection bias of study participants and bias associated with self-report measurement. CONCLUSIONS: Sexual problems were significant in this population but were not related to relationship satisfaction in this cross-sectional survey. Byrne M, Murphy P, D'Eath M, et al. Association Between Sexual Problems and Relationship Satisfaction Among People With Cardiovascular Disease. J Sex Med 2017;14:666-674.

Local anaesthesia versus spinal anaesthesia in inguinal hernia repair: A systematic review and meta-analysis.

BACKGROUND: Inguinal hernias are a significant cause of morbidity. The purpose of this systematic review and meta-analysis is to determine the totality of evidence regarding the effectiveness of local anaesthesia when compared to spinal anaesthesia in individuals undergoing open inguinal hernia repair. METHODS: A systematic literature search was conducted. Inclusion criteria were randomised controlled trials (RCTs) comparing spinal and local anaesthesia on clinical and self-reported outcomes, in patients undergoing open inguinal hernia repairs. The methodological quality was assessed using the Cochrane risk of bias tool. The mode of analysis used was the difference in outcomes between the groups post-surgery and at follow-up time points. Statistical heterogeneity was assessed using the I2 statistic. RESULTS: Ten original RCTs were included, with a total of 1379 patients. There was no significant difference in operative time between the groups [Random Effects Model, MD -0.70 min (95% CI, -5.80 to 4.40 min), p = 0.79, I2 = 84%]. Patients in the local anaesthetic group experienced significantly less pain than those in the spinal group [Fixed Effects Model, SMD -0.63 (95% CI, -0.81 to -0.46), p < 0.01, I2 = 49%], lower rates of urinary retention [FEM, RR 0.03 (95% CI 0.01-0.08), p < 0.01, I2 = 0%], decreased rates of anaesthetic failure [FEM, OR 0.17 (95% CI 0.06-0.45), p < 0.01, I2 = 0%], and increased satisfaction with the anaesthetic [FEM, OR 3.40 (95% CI 2.09-5.52), p < 0.01, I2 = 0%]. The methodological quality of studies was variable. CONCLUSION: Our findings support the use of local anaesthetic in adult patients undergoing open repair for a primary inguinal hernia.

Novel Genetic Variants for Cartilage Thickness and Hip Osteoarthritis.

Osteoarthritis is one of the most frequent and disabling diseases of the elderly. Only few genetic variants have been identified for osteoarthritis, which is partly due to large phenotype heterogeneity. To reduce heterogeneity, we here examined cartilage thickness, one of the structural components of joint health. We conducted a genome-wide association study of minimal joint space width (mJSW), a proxy for cartilage thickness, in a discovery set of 13,013 participants from five different cohorts and replication in 8,227 individuals from seven independent cohorts. We identified five genome-wide significant (GWS, P≤5·0×10-8) SNPs annotated to four distinct loci. In addition, we found two additional loci that were significantly replicated, but results of combined meta-analysis fell just below the genome wide significance threshold. The four novel associated genetic loci were located in/near TGFA (rs2862851), PIK3R1 (rs10471753), SLBP/FGFR3 (rs2236995), and TREH/DDX6 (rs496547), while the other two (DOT1L and SUPT3H/RUNX2) were previously identified. A systematic prioritization for underlying causal genes was performed using diverse lines of evidence. Exome sequencing data (n = 2,050 individuals) indicated that there were no rare exonic variants that could explain the identified associations. In addition, TGFA, FGFR3 and PIK3R1 were differentially expressed in OA cartilage lesions versus non-lesioned cartilage in the same individuals. In conclusion, we identified four novel loci (TGFA, PIK3R1, FGFR3 and TREH) and confirmed two loci known to be associated with cartilage thickness.The identified associations were not caused by rare exonic variants. This is the first report linking TGFA to human OA, which may serve as a new target for future therapies.

Intercritical circulating levels of neo-epitopes reflecting matrixmetalloprotease-driven degradation as markers of gout and frequent gout attacks.

OBJECTIVE: Recurrent flares constitute the main clinical burden of gout. Our aim was to assess whether biomarkers measuring MMP tissue degradation could be used as markers of frequent gout flares. METHODS: Fasting plasma samples from 112 men with gout and 170 controls, along with serum samples from 447 men with gout collected at baseline from an ongoing clinical trial, were analysed by ELISA for neo-epitopes from MMP degradation of collagens type I (C1M) and type III (C3M). The log10 levels of both markers were compared between cases and controls and between gout patients with three or more gout attacks in the past year and those with two or less attacks. RESULTS: The circulating levels of C1M and C3M correlated with gout status in the case-control study. Levels of both markers were associated with frequent gout flares (⩾3 attacks in the past year) in both cohorts (odds ratio, OR = 3.1; 95% CI: 1.4, 6.8; P = 0.0056 for log10C1M, and OR = 6.7; 95% CI: 2.3, 19.3; P = 0.0005 for log10C3M). The area under the curve in a receiver operating characteristic analysis of frequent flares increased from 0.68 to 0.74 in one cohort and from 0.60 to 0.66 in the other when log10C1M and log10C3M were added to clinical variables of the model. CONCLUSION: C1M and C3M, reflective of interstitial matrix destruction, are associated with gout status and with frequent gout flares in men, suggesting that increased MMP activity may contribute to gout flares. Further research is needed to find out whether this is independent of dietary and lifestyle risk factors for acute gout.

Sexual counselling for patients with cardiovascular disease: protocol for a pilot study of the CHARMS sexual counselling intervention.

INTRODUCTION: Sexual problems are common with cardiovascular disease, and can negatively impact quality of life. To address sexual problems, guidelines have identified the importance of sexual counselling during cardiac rehabilitation, yet this is rarely provided. The Cardiac Health and Relationship Management and Sexuality (CHARMS) intervention aims to improve the provision of sexual counselling in cardiac rehabilitation in Ireland. METHODS AND ANALYSIS: This is a multicentre pilot study for the CHARMS intervention, a complex, multilevel intervention delivered within hospital-based cardiac rehabilitation programmes. The intervention includes (1) training in sexual counselling for staff, (2) a staff-led patient education and support intervention embedded within the cardiac rehabilitation programme, (3) a patient information booklet and (4) an awareness raising poster. The intervention will be delivered in two randomly selected cardiac rehabilitation centres. In each centre 30 patients will be recruited, and partners will also be invited to participate. Data will be collected from staff and patients/partners at T1 (study entry), T2 (3-month follow-up) and T3 (6-month follow-up). The primary outcome for patients/partners will be scores on the Sexual Self-Perception and Adjustment Questionnaire. Secondary outcomes for patients/partners will include relationship satisfaction; satisfaction with and barriers to sexual counselling in services; sexual activity, functioning and knowledge; physical and psychological well-being. Secondary outcomes for staff will include sexuality-related practice; barriers to sexual counselling; self-ratings of capability, opportunity and motivation; sexual attitudes and beliefs; knowledge of cardiovascular disease and sex. Fidelity of intervention delivery will be assessed using trainer self-reports, researcher-coded audio recordings and exit interviews. Longitudinal feasibility data will be gathered from patients/partners and staff via questionnaires and interviews. ETHICS AND DISSEMINATION: This study is approved by the Research Ethics Committee (REC) of the National University of Ireland, Galway. Findings will be disseminated to cardiac rehabilitation staff, patients/partners and relevant policymakers via appropriate publications and presentations.

Erosive and osteoarthritic structural progression in early rheumatoid arthritis.

OBJECTIVES: To investigate factors associated with joint damage in early RA, and how comorbid OA might influence patient assessment and outcomes. METHODS: Baseline radiographs of hands and feet from 512 participants in the Early RA Network cohort, and after 3 (±1) years, 166 of those participants yielded complete scores for RA [erosions, joint space narrowing (JSN)] and OA [JSN, osteophytes (OST)] using validated atlases. DAS28-P is the proportion of DAS28 attributed to patient-reported factors. Adjusted odds ratios were calculated using logistic regression. RESULTS: OA was common at baseline in early RA (40% hand and 48% foot) and associated with RA radiographic score. Higher baseline RA scores were associated with increasing age and ESR, and lower DAS28-P. OST scores were associated with higher age. DAS28 and patient-reported outcomes improved, whereas RA and OA radiographic scores deteriorated by follow-up. Erosive progression was predicted by higher baseline erosions, female gender, better mental health and lower DAS28-P. Hand OST progression was predicted by baseline OST scores. Inflammatory disease activity was associated with erosive, but not with OA progression. Baseline hand OA predicted worse physical function at follow-up, but radiographic progression did not explain changes in patient-reported outcomes. CONCLUSION: OA is a common comorbidity that might confound radiographic and clinical assessment, but does not fully explain erosive progression or patient-reported outcomes in early RA. Early RA management should address psychosocial factors and comorbidities, as well as joint inflammation.

Sexual counselling for sexual problems in patients with cardiovascular disease.

BACKGROUND: Sexual problems are common among people with cardiovascular disease. Although clinical guidelines recommend sexual counselling for patients and their partners, there is little evidence on its effectiveness. OBJECTIVES: To evaluate the effectiveness of sexual counselling interventions (in comparison to usual care) on sexuality-related outcomes in patients with cardiovascular disease and their partners. SEARCH METHODS: We searched CENTRAL, MEDLINE, EMBASE, and three other databases up to 2 March 2015 and two trials registers up to 3 February 2016. SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-RCTs, including individual and cluster RCTs. We included studies that compared any intervention to counsel adult cardiac patients about sexual problems with usual care. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We included three trials with 381 participants. We were unable to pool the data from the included studies due to the differences in interventions used; therefore we synthesised the trial findings narratively.Two trials were conducted in the USA and one was undertaken in Israel. All trials included participants who were admitted to hospital with myocardial infarction (MI), and one trial also included participants who had undergone coronary artery bypass grafting. All trials followed up participants for a minimum of three months post-intervention; the longest follow-up timepoint was five months.One trial (N = 92) tested an intensive (total five hours) psychotherapeutic sexual counselling intervention delivered by a sexual therapist. One trial (N = 115) used a 15-minute educational video plus written material on resuming sexual activity following a MI. One trial (N = 174) tested the addition of a component that focused on resumption of sexual activity following a MI within a hospital cardiac rehabilitation programme.The quality of the evidence for all outcomes was very low.None of the included studies reported any outcomes from partners.Two trials reported sexual function. One trial compared intervention and control groups on 12 separate sexual function subscales and used a repeated measures analysis of variance (ANOVA) test. They reported statistically significant differences in favour of the intervention. One trial compared intervention and control groups using a repeated measures analysis of covariance (ANCOVA), and concluded: "There were no significant differences between the two groups [for sexual function] at any of the time points".Two trials reported sexual satisfaction. In one trial, the authors compared sexual satisfaction between intervention and control and used a repeated measured ANOVA; they reported "differences were reported in favour of the intervention". One trial compared intervention and control with a repeated measures ANCOVA and reported: "There were no significant differences between the two groups [for sexual satisfaction] at any of the timepoints".All three included trials reported the number of patients returning to sexual activity following MI. One trial found some evidence of an effect of sexual counselling on reported rate of return to sexual activity (yes/no) at four months after completion of the intervention (relative risk (RR) 1.71, 95% confidence interval (CI) 1.26 to 2.32; one trial, 92 participants, very low quality of evidence). Two trials found no evidence of an effect of sexual counselling on rate of return to sexual activity at 12 week (RR 1.01, 95% CI 0.94 to 1.09; one trial, 127 participants, very low quality of evidence) and three month follow-up (RR 0.98, 95% CI 0.88 to 1.10; one trial, 115 participants, very low quality of evidence).Two trials reported psychological well-being. In one trial, no scores were reported, but the trial authors stated: "No treatment effects were observed on state anxiety as measured in three points in time". In the other trial no scores were reported but, based on results of a repeated measures ANCOVA to compare intervention and control groups, the trial authors stated: "The experimental group had significantly greater anxiety at one month post MI". They also reported: "There were no significant differences between the two groups [for anxiety] at any other time points".One trial reporting relationship satisfaction and one trial reporting quality of life found no differences between intervention and control.No trial reported on satisfaction in how sexual issues were addressed in cardiac rehabilitation services. AUTHORS' CONCLUSIONS: We found no high quality evidence to support the effectiveness of sexual counselling for sexual problems in patients with cardiovascular disease. There is a clear need for robust, methodologically rigorous, adequately powered RCTs to test the effectiveness of sexual counselling interventions for people with cardiovascular disease and their partners.