Modified dietary fat intake for treatment of gallstone disease in people of any age.

BACKGROUND: The prevalence of gallstones varies between less than 1% and 64% in different populations and is thought to be increasing in response to changes in nutritional intake and increasing obesity. Some people with gallstones have no symptoms but approximately 2% to 4% develop them each year, predominantly including severe abdominal pain. People who experience symptoms have a greater risk of developing complications. The main treatment for symptomatic gallstones is cholecystectomy. Traditionally, a low-fat diet has also been advised to manage gallstone symptoms, but there is uncertainty over the evidence to support this. OBJECTIVES: To evaluate the benefits and harms of modified dietary fat intake in the treatment of gallstone disease in people of any age. SEARCH METHODS: We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials in the Cochrane Library, MEDLINE ALL Ovid, Embase Ovid, and three other databases to 17 February 2023 to identify randomised clinical trials in people with gallstones. We also searched online trial registries and pharmaceutical company sources, for ongoing or unpublished trials to March 2023. SELECTION CRITERIA: We included randomised clinical trials (irrespective of language, blinding, or status) in people with gallstones diagnosed using ultrasonography or conclusive imaging methods. We excluded participants diagnosed with another condition that may compromise dietary fat tolerance. We excluded trials where data from participants with gallstones were not reported separately from data from participants who did not have gallstones. We included trials that investigated other interventions (e.g. trials of drugs or other dietary (non-fat) components) providing that the trial groups had received the same proportion of drug or other dietary (non-fat) components in the intervention. DATA COLLECTION AND ANALYSIS: We intended to undertake meta-analysis and present the findings according to Cochrane recommendations. However, as we identified only five trials, with data unsuitable and insufficient for analyses, we described the data narratively. MAIN RESULTS: We included five trials but only one randomised clinical trial (69 adults), published in 1986, reported outcomes of interest to the review. The trial had four dietary intervention groups, three of which were relevant to this review. We assessed the trial at high risk of bias. The dietary fat modifications included a modified cholesterol intake and medium-chain triglyceride supplementation. The control treatment was a standard diet. The trial did not report on any of the primary outcomes in this review (i.e. all-cause mortality, serious adverse events, and health-related quality of life). The trial reported on gallstone dissolution, one of our secondary outcomes. We were unable to apply the GRADE approach to determine certainty of evidence because the included trial did not provide data that could be used to generate an estimate of the effect on this or any other outcome. The trial expressed its finding as "no significant effect of a low-cholesterol diet in the presence of ursodeoxycholic acid on gallstone dissolution." There were no serious adverse events reported. The included trial reported that they received no funding that could bias the trial results through conflicts of interest. We found no ongoing trials. AUTHORS' CONCLUSIONS: The evidence about the effects of modifying dietary fat on gallstone disease versus standard diet is scant. We lack results from high-quality randomised clinical trials which investigate the effects of modification of dietary fat and other nutrient intakes with adequate follow-up. There is a need for well-designed trials that should include important clinical outcomes such as mortality, quality of life, impact on dissolution of gallstones, hospital admissions, surgical intervention, and adverse events.

What works for whom in the management of diabetes in people living with dementia: a realist review.

BACKGROUND: Dementia and diabetes mellitus are common long-term conditions and co-exist in a large number of older people. People living with dementia (PLWD) may be less able to manage their diabetes, putting them at increased risk of complications such as hypoglycaemia. The aim of this review was to identify key mechanisms within different interventions that are likely to improve diabetes outcomes in PLWD. METHODS: This is a realist review involving scoping of the literature and stakeholder interviews to develop theoretical explanations of how interventions might work, systematic searches of the evidence to test and develop the theories and their validation with a purposive sample of stakeholders. Twenty-six stakeholders - user/patient representatives, dementia care providers, clinicians specialising in diabetes or dementia and researchers - took part in interviews, and 24 participated in a consensus conference. RESULTS: We included 89 papers. Ten focused on PLWD and diabetes, and the remainder related to people with either dementia, diabetes or other long-term conditions. We identified six context-mechanism-outcome configurations which provide an explanatory account of how interventions might work to improve the management of diabetes in PLWD. This includes embedding positive attitudes towards PLWD, person-centred approaches to care planning, developing skills to provide tailored and flexible care, regular contact, family engagement and usability of assistive devices. An overarching contingency emerged concerning the synergy between an intervention strategy, the dementia trajectory and social and environmental factors, especially family involvement. CONCLUSIONS: Evidence highlighted the need for personalised care, continuity and family-centred approaches, although there was limited evidence that this happens routinely. This review suggests there is a need for a flexible service model that prioritises quality of life, independence and patient and carer priorities. Future research on the management of diabetes in older people with complex health needs, including those with dementia, needs to look at how organisational structures and workforce development can be better aligned to their needs. TRIAL REGISTRATION: PROSPERO, CRD42015020625. Registered on 18 May 2015.

Simvastatin improves the sexual health-related quality of life in men aged 40 years and over with erectile dysfunction: additional data from the erectile dysfunction and statin trial.

BACKGROUND: Erectile dysfunction is prevalent in men over 40 years, affecting their quality of life and that of their partners. The aims of this study were:a) To evaluate the internal reliability of the male erectile dysfunction specific quality of life (MED-QoL) scale and explore its factor structure.b) To evaluate the effect of simvastatin on subscales of the MED-QoL in men over forty years with erectile dysfunction. METHODS: This is a double blind randomised controlled trial of 40 mg simvastatin or placebo given once daily for six months to men over forty years with untreated erectile dysfunction, who were not at high cardiovascular risk and were not on anti-hypertensive or lipid-lowering medication. 173 eligible men were recruited from 10 general practices in East of England. Data were collected at two points over 30 weeks.We report on the factor structure of MED-QoL, the internal reliability of the scale and the derived subscales, and the effect of simvastatin on MED-QoL subscales. RESULTS: An initial analysis of the MED-QoL items suggested that a number of items should be removed (MED-QoL-R). Exploratory factor analysis identified three subscales within the MED-QoL-R which accounted for 96% of the variance, related to feelings of Control, initiating Intimacy, and Emotional response to erectile dysfunction. The alpha value for the revised scale (MED-Qol-R) was >0.95 and exceeded .82 for each subscale. Regression analysis showed that patients in the placebo group experienced a significantly reduced feeling of Control over erectile dysfunction than those in the statin group. Those in the placebo group had significantly lower Emotional response than those in the statin group at the close of trial, but there was no significant treatment effect on Intimacy. CONCLUSIONS: Our revised MED-QoL-R identified three subscales. Secondary analysis showed a significant improvement in sexual health related quality of life, specifically in relation to perception of control and emotional health in men with untreated erectile dysfunction given 40 mg simvastatin for six months. TRIAL REGISTRATION: Current Controlled Trials ISRCTN66772971.

Facilitators and barriers of digital health technologies implementation in hospital settings in lower-income and middle-income countries since the COVID-19 pandemic: a scoping review protocol.

INTRODUCTION: The implementation of digital health technologies (DHTs) in hospitals worldwide has been uneven since the COVID-19 pandemic. Ambiguity in defining the landscape of DHTs adds to the complexity of this process. To address these challenges, this scoping review aims to identify the facilitators and barriers of implementing DHTs in hospitals in lower-income and middle-income countries (LMIC) since COVID-19, describe the DHTs that have been adopted in hospital settings in LMIC during this period, and develop a comprehensive classification framework to define the landscape of DHTs implemented in LMIC. METHODS AND ANALYSIS: We will conduct a systematic search in PubMed, Scopus, Web of Science and grey literature. Descriptive statistics will be used to report the characteristics of included studies. The facilitators and barriers to DHTs implementation, gathered from both quantitative and qualitative data, will be synthesised using a parallel-results convergent synthesis design. A thematic analysis, employing an inductive approach, will be conducted to categorise these facilitators and barriers into coherent themes. Additionally, we will identify and categorise all available DHTs based on their equipment types and methods of operation to develop an innovative classification framework. ETHICS AND DISSEMINATION: Formal ethical approval is not required, as primary data collection is not involved in this study. The findings will be disseminated through peer-reviewed publications, conference presentations and meetings with key stakeholders and partners in the field of digital health.

Testing a faith-placed education intervention for bowel cancer screening in Muslim communities using a two-group non-randomised mixed-methods approach: Feasibility study protocol.

BACKGROUND: Inequalities exist in uptake of bowel cancer screening in England with low uptake in areas with high deprivation and amongst certain ethnic and religious groups. Individuals from these groups are more likely to receive a late diagnosis of bowel cancer. Uptake in Muslim communities, for example, has been shown to be lower than in the general population. Culturally adapted interventions are needed to address these inequalities. This feasibility study aims to assess the acceptability and accessibility of an educational faith-placed bowel cancer screening intervention in the East of England, alongside its impact on bowel screening uptake. It was developed by the British Islamic Medical Association in partnership with community stakeholders and professionals. METHODS: Ethical approval was granted on the 27 October 2021, REC reference number 21/EE/0231. A two-group non-randomised feasibility mixed methods study will be conducted, using surveys, focus groups and semi-structured interviews. Participants eligible for bowel screening will be recruited through local mosques and community venues. We aim to recruit 100 participants to the intervention group and 150 to the comparison group (not receiving the intervention). Intervention group participants will complete a survey at baseline, post-intervention and at six-month follow up. Comparison group participants will complete a survey at baseline and at six-month follow up. Outcomes will include: intention to take up screening; actual screening uptake; knowledge, attitudes, barriers and facilitators towards screening. Regional screening hub records will be used to ascertain actual screening uptake at six-month follow-up. Quantitative survey data will be summarised using descriptive statistics (e.g., proportion), and exploratory univariate analysis will be undertaken (e.g., chi-squared test). Two focus group interviews will be conducted with intervention group participants (with up to 16 participants). Semi-structured interviews will be conducted with 10 clinicians delivering the intervention to explore the acceptability of the intervention, training, and delivery. All qualitative data will be subject to a general inductive analysis. DISCUSSION: The findings will inform how faith-placed interventions can be implemented to increase uptake of bowel cancer screening, and potentially other health promotion programmes, to address health inequalities in ethnically diverse communities in England.

Triggers and factors associated with moral distress and moral injury in health and social care workers: A systematic review of qualitative studies.

OBJECTIVE: At some point in their career, many healthcare workers will experience psychological distress associated with being unable to take morally or ethically correct action, as it aligns with their own values; a phenomenon known as moral distress. Similarly, there are increasing reports of healthcare workers experiencing long-term mental and psychological pain, alongside internal dissonance, known as moral injury. This review examined the triggers and factors associated with moral distress and injury in Health and Social Care Workers (HSCW) employed across a range of clinical settings with the aim of understanding how to mitigate the effects of moral distress and identify potential preventative interventions. METHODS: A systematic review was conducted and reported according to recommendations from Cochrane and Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Searches were conducted and updated regularly until January 2024 on 2 main databases (CENTRAL, PubMed) and three specialist databases (Scopus, CINAHL, PsycArticles), alongside hand searches of study registration databases and other systematic reviews reference lists. Eligible studies included a HSCW sample, explored moral distress/injury as a main aim, and were written in English or Italian. Verbatim quotes were extracted, and article quality was assessed via the CASP toolkit. Thematic analysis was conducted to identify patterns and arrange codes into themes. Specific factors like culture and diversity were explored, and the effects of exceptional circumstances like the pandemic. RESULTS: Fifty-one reports of 49 studies were included in the review. Causes and triggers were categorised under three domains: individual, social, and organisational. At the individual level, patients' care options, professionals' beliefs, locus of control, task planning, and the ability to make decisions based on experience, were indicated as elements that can cause or trigger moral distress. In addition, and relevant to the CoVID-19 pandemic, was use/access to personal protection resources. The social or relational factors were linked to the responsibility for advocating for and communication with patients and families, and professionals own support network. At organisational levels, hierarchy, regulations, support, workload, culture, and resources (staff and equipment) were identified as elements that can affect professionals' moral comfort. Patients' care, morals/beliefs/standards, advocacy role and culture of context were the most referenced elements. Data on cultural differences and diversity were not sufficient to make assumptions. Lack of resources and rapid policy changes have emerged as key triggers related to the pandemic. This suggests that those responsible for policy decisions should be mindful of the potential impact on staff of sudden and top-down change. CONCLUSION: This review indicates that causes and triggers of moral injury are multifactorial and largely influenced by the context and constraints within which professionals work. Moral distress is linked to the duty and responsibility of care, and professionals' disposition to prioritise the wellbeing of patients. If the organisational values and regulations are in contrast with individuals' beliefs, repercussions on professionals' wellbeing and retention are to be expected. Organisational strategies to mitigate against moral distress, or the longer-term sequalae of moral injury, should address the individual, social, and organisational elements identified in this review.

Can simvastatin improve erectile function and health-related quality of life in men aged ≥40 years with erectile dysfunction? Results of the Erectile Dysfunction and Statins Trial [ISRCTN66772971].

OBJECTIVE: To evaluate the effectiveness and cost-effectiveness of simvastatin on erectile function and health-related quality of life in men aged ≥40 years with erectile dysfunction (ED). PATIENTS AND METHODS: ED is common in men aged ≥40 years and impacts upon their overall health-related quality of life and that of their partners. Men aged ≥40 years who were not receiving lipid lowering or anti-hypertensive medication and not at high cardiovascular risk were recruited from 10 general practices in the East of England. In total, 173 eligible men with untreated ED were randomized to double-blind treatment with 40 mg of simvastatin or placebo once daily for 6 months. Data were collected at three points over 30 weeks. The main outcome was erectile function (International Index of Erectile Function-5 score). Secondary outcomes included male ED-specific quality of life (MED-QoL), quality-adjusted life years (QALYs) using the generic Euroqol measure (EQ-5D), endothelial function, cardiovascular risk, cholesterol and health service costs. RESULTS: There was no significant difference in erectile function between the simvastatin and placebo groups (mean change, 1.28 vs 0.07, z = 1.1, p = 0.27), although a significant improvement in MED-QoL was observed (5% vs 2%, z = 2.09, p = 0.04). Both 10-year cardiovascular risk and low-density lipoprotein were reduced (cardiovascular risk, z = -3.67, p < 0.001; low-density lipoprotein, z = -5.46, p < 0.001), with no consistent change in endothelial function. The frequency of sexual encounters is correlated with improved erectile function. The joint distribution of costs and QALY benefits indicates that the probability of simvastatin being cost-effective for willingness-to-pay thresholds of £20,000 and £30,000 is 86% and 83%, respectively. CONCLUSIONS: Identifying men with ED provides an opportunity to modify future cardiovascular risk and to improve MED-QoL by treating them with 40 mg of simvastatin. The joint analysis of costs and QALY benefits suggests that there is high probability that simvastatin is a cost-effective strategy in men with ED. The findings could influence urological and primary care practice by including questions on ED during routine consultations and relevant clinical protocols. This provides an opportunity to impart lifestyle advice.

Use of social media in recruiting young people to mental health research: a scoping review.

OBJECTIVES: This review explored the literature on the use of social media in recruiting young people, aged 13-18 years, to mental health research. It aimed to identify barriers and facilitators to recruitment and strategies to improve participation in future research. DESIGN: Scoping review. DATA SOURCES: Articles published between January 2011 and February 2023 were searched for on PubMed, Scopus, Medline (via EBSCOhost) and Cochrane Library databases. ELIGIBILITY CRITERIA: Studies that outlined social media as a recruitment method and recruited participants aged 13-18 years. DATA EXTRACTION AND SYNTHESIS: Data was extracted by two reviewers independently and cross-checked by a third reviewer. Data on study design, aims, participants, recruitment methods and findings related specifically to social media as a recruitment tool were collected. RESULTS: 24 journal articles met the inclusion criteria. Studies were predominantly surveys (n=13) conducted in the USA (n=16) recruiting via Facebook (n=16) and/or Instagram (n=14). Only nine of the included articles provided a summary of success and reviewed the efficacy of social media recruitment for young people in mental health research. Type of advertisement, the language used, time of day and the use of keywords were all found to be factors that may influence the success of recruitment through social media; however, as these are based on findings from a small number of studies, such potential influences require further investigation. CONCLUSION: Social media recruitment can be a successful method for recruiting young people to mental health research. Further research is needed into recruiting socioeconomically marginalised groups using this method, as well as the effectiveness of new social media platforms. REGISTRATION: Open Science Framework Registry (https://osf.io/mak75/).

Colloid solutions for fluid resuscitation.

BACKGROUND: Colloids are widely used in the replacement of fluid volume. However doubts remain as to which colloid is best. Different colloids vary in their molecular weight and therefore in the length of time they remain in the circulatory system. Because of this and their other characteristics, they may differ in their safety and efficacy. OBJECTIVES: To compare the effects of different colloid solutions in patients thought to need volume replacement. SEARCH METHODS: We searched the Cochrane Injuries Specialised Register (searched 1 Dec 2011), Cochrane Central Register of Controlled Trials 2011, issue 4 (The Cochrane Library); MEDLINE (Ovid) (1948 to November Week 3 2011); EMBASE (Ovid) (1974 to 2011 Week 47); ISI Web of Science: Science Citation Index Expanded (1970 to 1 Dec 2011); ISI Web of Science: Conference Proceedings Citation Index-Science (1990 to 1 Dec 2011); CINAHL (EBSCO) (1982 to 1 Dec 2011); National Research Register (2007, Issue 1) and PubMed (searched 1 Dec 2011). Bibliographies of trials retrieved were searched, and for the initial version of the review drug companies manufacturing colloids were contacted for information (1999). SELECTION CRITERIA: Randomised controlled trials comparing colloid solutions in critically ill and surgical patients thought to need volume replacement. DATA COLLECTION AND ANALYSIS: Two authors independently extracted the data and assessed the quality of the trials. The outcomes sought were death, amount of whole blood transfused, and incidence of adverse reactions. MAIN RESULTS: Ninety trials, with a total of 5678 participants, met the inclusion criteria. Quality of allocation concealment was judged to be adequate in 35 trials and poor or uncertain in the rest.Deaths were obtained in 61 trials. For albumin or PPF versus hydroxyethyl starch (HES) 32 trials (n = 1769) reported mortality. The pooled relative risk (RR) was 1.07 (95% CI 0.87 to 1.32). When the trials by Boldt were removed from the analysis the pooled RR was 0.90 (95% CI 0.68 to 1.20). For albumin or PPF versus gelatin, nine trials (n = 824) reported mortality. The RR was 0.89 (95% CI 0.65 to 1.21). Removing the study by Boldt from the analysis did not change the RR or confidence intervals. For albumin or PPF versus Dextran four trials (n = 360) reported mortality. The RR was 3.75 (95% CI 0.42 to 33.09). For gelatin versus HES 25 trials (n = 1756) reported mortality and the RR was 1.03 (95% CI 0.84 to 1.26). When the trials by Boldt were removed from the analysis the pooled RR was 1.04 (95% CI 0.85 to 1.27). RR was not estimable in the gelatin versus dextran and HES versus dextran groups.Forty five trials recorded the amount of blood transfused, however quantitative analysis was not possible due to skewness and variable reporting. Twenty-four trials recorded adverse reactions, with two studies reporting possible adverse reactions to Gel and one to HES. AUTHORS' CONCLUSIONS: From this review, there is no evidence that one colloid solution is more effective or safe than any other, although the confidence intervals are wide and do not exclude clinically significant differences between colloids. Larger trials of fluid therapy are needed if clinically significant differences in mortality are to be detected or excluded.

Colloid solutions for fluid resuscitation.

BACKGROUND: Colloids are widely used in the replacement of fluid volume. However, doubts remain as to which colloid is best. Different colloids vary in their molecular weight and therefore in the length of time they remain in the circulatory system. Because of this, and their other characteristics, they may differ in their safety and efficacy. OBJECTIVES: To compare the effects of different colloid solutions in patients thought to need volume replacement. SEARCH METHODS: We searched the Cochrane Injuries Specialised Register (searched 1 December 2011), the Cochrane Central Register of Controlled Trials 2011, issue 4 (The Cochrane Library); MEDLINE (Ovid) (1948 to November Week 3 2011); EMBASE (Ovid) (1974 to 2011 Week 47); ISI Web of Science: Science Citation Index Expanded (1970 to 1 December 2011); ISI Web of Science: Conference Proceedings Citation Index-Science (1990 to 1 December 2011); CINAHL (EBSCO) (1982 to 1 December 2011); National Research Register (2007, Issue 1) and PubMed (searched 1 December 2011). Bibliographies of trials retrieved were searched, and for the initial version of the review drug companies manufacturing colloids were contacted for information (1999). SELECTION CRITERIA: Randomised controlled trials comparing colloid solutions in critically ill and surgical patients thought to need volume replacement. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted the data and assessed the quality of the trials. The outcomes sought were death, amount of whole blood transfused, and incidence of adverse reactions. MAIN RESULTS: Eighty-six trials, with a total of 5,484 participants, met the inclusion criteria. Quality of allocation concealment was judged to be adequate in 33 trials and poor or uncertain in the rest.Deaths were reported in 57 trials. For albumin or plasma protein fraction (PPF) versus hydroxyethyl starch (HES) 31 trials (n = 1719) reported mortality. The pooled relative risk (RR) was 1.06 (95% confidence interval (CI) 0.86 to 1.31). When the trials by Boldt were removed from the analysis the pooled RR was 0.90 (95% CI 0.68 to 1.20). For albumin or PPF versus gelatin, nine trials (n = 824) reported mortality. The RR was 0.89 (95% CI 0.65 to 1.21). Removing the study by Boldt from the analysis did not change the RR or CIs. For albumin or PPF versus dextran four trials (n = 360) reported mortality. The RR was 3.75 (95% CI 0.42 to 33.09). For gelatin versus HES 22 trials (n = 1612) reported mortality and the RR was 1.02 (95% CI 0.84 to 1.26). When the trials by Boldt were removed from the analysis the pooled RR was 1.03 (95% CI 0.84 to 1.27). RR was not estimable in the gelatin versus dextran and HES versus dextran groups.Forty-one trials recorded the amount of blood transfused; however, quantitative analysis was not possible due to skewness and variable reporting. Twenty-four trials recorded adverse reactions, with two studies reporting possible adverse reactions to gel and one to HES. AUTHORS' CONCLUSIONS: From this review, there is no evidence that one colloid solution is more effective or safe than any other, although the CIs were wide and do not exclude clinically significant differences between colloids. Larger trials of fluid therapy are needed if clinically significant differences in mortality are to be detected or excluded.

Outcome evaluation of Active Herts: A community-based physical activity programme for inactive adults at risk of cardiovascular disease and/or low mental wellbeing.

Background: A high proportion of UK adults are inactive, which can lead to a range of physical and mental health concerns. Active Herts is a community-based physical activity programme for inactive adults at risk of cardiovascular disease and/or low mental wellbeing. This paper provides a pragmatic evaluation of this programme. Method: This longitudinal study observed 717 adults (68% female, mean age = 56.9 years) from the "Active Herts" programme. Programme users were provided with a 45-min consultation with a "Get Active Specialist," who talked them through an Active Herts self-help booklet and then signposted them to free or subsidized local exercise sessions. Programme users were followed up with a booster call 2 weeks later. The Get Active Specialist was a registered exercise professional (REPS Level 3), with additional training from the study team in motivational interviewing, health coaching, COM-B behavioral diagnosis and delivery of behavior change techniques (BCTs) in practice. The Active Herts booklet contained theoretically-driven and evidence-based BCTs to translate behavioral science into public health practice. Physical activity (Metabolic Equivalent Time [METs], measured using the International Physical Activity Questionnaire (IPAQ), perceived health (EQ-5D-5L) and mental wellbeing (Warwick-Edinburgh Mental Wellbeing Scale: WEMWBS) were measured at baseline, 3, 6 and 12 months. Results: At the end of the 12-month programme, users showed sustained improvements in physical activity (by +1331 METS), exceeding weekly recommendations. Sitting (reducing by over an hour per day), sporting participation, and perceptions of health were also improved, with improvements in mental wellbeing in the first 3 months. Conclusion: Designing and delivering a community-based physical activity programme that is theoretically-driven and evidence-based with frequent behavior change training and supervision can yield a significant increase in self-reported physical activity, reduction in sitting behavior and improvements to perceived health and mental wellbeing. Future research should extend this approach, utilizing a real-world, pragmatic evaluation. Trial registration: ClinicalTrials.gov, identifier (NCT number): NCT03153098.

Can simvastatin improve erectile function and health-related quality of life in men aged >40 years with erectile dysfunction? Rationale and design of the Erectile Dysfunction and Statins (EDS) Trial [ISRCTN66772971](1).

UNLABELLED: What's known on the subject? and What will the study add? Erectile dysfunction is often associated with endothelial dysfunction. It is also recognized as a marker for underlying vascular disease. This study tests the hypothesis that statin therapy may improve erectile function and also reduce the risk of future cardiovascular events via a reduction in serum cholesterol and by improving endothelial function. The study will also determine whether the treatment improves quality of life related to sexual function. OBJECTIVE: • To describe the rationale and design of the Erectile Dysfunction and Statins (EDS) Trial which aims to evaluate the effectiveness of simvastatin on erectile function and health-related quality of life in men aged ≥40 years with erectile dysfunction. PATIENTS AND METHODS: • The study is a randomized, double-blind, placebo-controlled trial to test the hypotheses that statins improve endothelial function and reduce cholesterol and may improve erectile function in men with untreated erectile dysfunction (ED). • Study subjects are men ≥40 years who are not receiving lipid-lowering or anti-hypertensive medication and have no other cardiovascular disease (CVD) risk factors. • Eligible men with untreated ED are randomized to double-blind treatment with 40 mg simvastatin or placebo once daily for 6 months. • Data are collected at baseline, mid-trial and at the final follow-up visit at 30 weeks. • The main outcome is erectile function measured by the five-item version of the International Index of Erectile Function. Secondary outcomes include sexual-health-related quality of life and endothelial function. RESULTS: • Ten general practices have been recruited in the east of England. • We have randomized 173 men for a power of 90% to assess the main outcome. • To date there have been no serious unexpected adverse events. • Study findings will be available in September 2011. CONCLUSION: • If simvastatin improves erectile function it would provide an inexpensive treatment for ED suitable for most men, and reduce the risk of future CVD.

Colloid solutions for fluid resuscitation.

BACKGROUND: Colloids are widely used in the replacement of fluid volume. However doubts remain as to which colloid is best. Different colloids vary in their molecular weight and therefore in the length of time they remain in the circulatory system. Because of this and their other characteristics, they may differ in their safety and efficacy. OBJECTIVES: To compare the effects of different colloid solutions in patients thought to need volume replacement. SEARCH STRATEGY: We searched the Cochrane Injuries Group's specialised register, CENTRAL (2007, Issue 1), MEDLINE (1994 to March 2007), EMBASE (1974 to March 2007), and the National Research Register (2007, Issue 1). Bibliographies of trials retrieved were searched, and drug companies manufacturing colloids were contacted for information. The search was last updated in March 2007. SELECTION CRITERIA: Randomised and quasi-randomised trials comparing colloid solutions in critically ill and surgical patients thought to need volume replacement. The outcomes measured were death, amount of whole blood transfused, and incidence of adverse reactions. DATA COLLECTION AND ANALYSIS: Two authors independently extracted the data and assessed the quality of the trials. MAIN RESULTS: Seventy trials, with a total of 4375 participants, met the inclusion criteria. Quality of allocation concealment was judged to be adequate in 24 trials and poor or uncertain in the rest.Deaths were obtained in 46 trials. For albumin or PPF versus hydroxyethyl starch (HES) 25 trials (n = 1234) reported mortality. The pooled relative risk (RR) was 1.14 (95% CI 0.91 to 1.43). When the trials by Boldt are removed from the analysis the pooled RR was 0.97 (95% CI 0.70 to 1.35). For albumin or PPF versus gelatin, seven trials (n = 636) reported mortality. The RR was 0.97 (95% CI 0.68 to 1.39). For albumin or PPF versus Dextran four trials (n = 360) reported mortality. The RR was 3.75 (95% CI 0.42 to 33.09). For gelatin versus HES 18 trials (n = 1337) reported mortality and RR was 1.00 (95% CI 0.80 to 1.25). RR was not estimable in the gelatin versus dextran and HES versus dextran groups.Thirty-seven trials recorded the amount of blood transfused, however quantitative analysis was not possible due to skewness and variable reporting. Nineteen trials recorded adverse reactions, but none occurred. AUTHORS' CONCLUSIONS: From this review, there is no evidence that one colloid solution is more effective or safe than any other, although the confidence intervals are wide and do not exclude clinically significant differences between colloids. Larger trials of fluid therapy are needed if clinically significant differences in mortality are to be detected or excluded.

Determinants of weekly sitting time: construct validation of an initial COM-B model and comparison of its predictive validity with the Theory of Planned Behaviour.

OBJECTIVE: In relation to sitting behaviour, to investigate which theoretical domains best formed the Capability, Opportunity, and Motivation constructs of the COM-B, and compare the predictive validity to the Theory of Planned Behaviour (TPB), taking habit strength into consideration. DESIGN: Using a prospective design, 186 adults completed measures capturing domains from the Theoretical Domains Framework for the three COM-B constructs, and habit strength, which were examined using a formative measurement model. Predictive validity was then compared to the TPB. MAIN OUTCOME MEASURES: Self-reported sitting behaviour. RESULTS: Self-monitoring (behavioural regulation domain) formed Capability; subjective norm (social influences domain) formed Opportunity; intention (intentions domain), positive affect (emotion domain), and perceived behavioural control (beliefs about capabilities domain), formed Motivation. The COM-B strongly predicted sitting behaviour (27% variance explained), with Capability, Opportunity, and habit strength as key drivers. The TPB explained a large amount of variance (23%) in sitting behaviour, with intention and habit strength as key drivers. CONCLUSIONS: The behavioural regulation domain of Capability, the social influences domain of Opportunity, and habit strength were important drivers of sitting behaviour, with comparable variance predicted in the COM-B and TPB. Future research should consider this approach to conceptualise the COM-B for specific populations and behaviours.

A prospective study exploring the construct and predictive validity of the COM-B model for physical activity.

This study examined the constructs of capability, opportunity and motivation from the COM-B model and their influence on moderate-to-vigorous physical activity. Using a prospective survey design, 186 healthy adults completed measures representing the theoretical domains framework mapped to the COM-B, and moderate-to-vigorous physical activity 1 week later. The main indicators for the COM constructs were 'habits' (Capability), 'subjective norms' (Opportunity) and 'exercise self-identity' (Motivation). Motivation (77%) and moderate-to-vigorous physical activity (50%) were strongly predicted, with Capability and Motivation as key drivers of behaviour. Motivation was a strong mediator for Capability on behaviour. Future research should consider this approach for other populations and behaviours.

Are physical activity interventions for healthy inactive adults effective in promoting behavior change and maintenance, and which behavior change techniques are effective? A systematic review and meta-analysis.

Physical inactivity and sedentary behavior relate to poor health outcomes independently. Healthy inactive adults are a key target population for prevention. This systematic review and meta-analysis aimed to evaluate the effectiveness of physical activity and/or sedentary behavior interventions, measured postintervention (behavior change) and at follow-up (behavior change maintenance), to identify behavior change techniques (BCT) within, and report on fidelity. Included studies were randomized controlled trials, targeting healthy inactive adults, aiming to change physical activity and/or sedentary behavior, with a minimum postintervention follow-up of 6 months, using 16 databases from 1990. Two reviewers independently coded risk of bias, the "Template for Intervention Description and Replication" (TIDieR) checklist, and BCTs. Twenty-six studies were included; 16 pooled for meta-analysis. Physical activity interventions were effective at changing behavior (d = 0.32, 95% confidence intervals = 0.16-0.48, n = 2,346) and maintaining behavior change after 6 months or more (d = 0.21, 95% confidence intervals = 0.12-0.30, n = 2,190). Sedentary behavior interventions (n = 2) were not effective. At postintervention, physical activity intervention effectiveness was associated with the BCTs "Biofeedback," "Demonstration of the behavior," "Behavior practice/rehearsal," and "Graded tasks." At follow-up, effectiveness was associated with using "Action planning," "Instruction on how to perform the behavior," "Prompts/cues," "Behavior practice/rehearsal," "Graded tasks," and "Self-reward." Fidelity was only documented in one study. Good evidence was found for behavior change maintenance effects in healthy inactive adults, and underlying BCTs. This review provides translational evidence to improve research, intervention design, and service delivery in physical activity interventions, while highlighting the lack of fidelity measurement.

Managing diabetes in people with dementia: a realist review.

BACKGROUND: Dementia and diabetes mellitus are common long-term conditions that coexist in a large number of older people. People living with dementia and diabetes may be at increased risk of complications such as hypoglycaemic episodes because they are less able to manage their diabetes. OBJECTIVES: To identify the key features or mechanisms of programmes that aim to improve the management of diabetes in people with dementia and to identify areas needing further research. DESIGN: Realist review, using an iterative, stakeholder-driven, four-stage approach. This involved scoping the literature and conducting stakeholder interviews to develop initial programme theories, systematic searches of the evidence to test and develop the theories, and the validation of programme theories with a purposive sample of stakeholders. PARTICIPANTS: Twenty-six stakeholders (user/patient representatives, dementia care providers, clinicians specialising in dementia or diabetes and researchers) took part in interviews and 24 participated in a consensus conference. DATA SOURCES: The following databases were searched from 1990 to March 2016: MEDLINE (PubMed), Cumulative Index to Nursing and Allied Health Literature, Scopus, The Cochrane Library (including the Cochrane Database of Systematic Reviews), Database of Abstracts of Reviews of Effects, the Health Technology Assessment (HTA) database, NHS Economic Evaluation Database, AgeInfo (Centre for Policy on Ageing - UK), Social Care Online, the National Institute for Health Research (NIHR) portfolio database, NHS Evidence, Google (Google Inc., Mountain View, CA, USA) and Google Scholar (Google Inc., Mountain View, CA, USA). RESULTS: We included 89 papers. Ten papers focused directly on people living with dementia and diabetes, and the rest related to people with dementia or diabetes or other long-term conditions. We identified six context-mechanism-outcome (CMO) configurations that provide an explanatory account of how interventions might work to improve the management of diabetes in people living with dementia. This includes embedding positive attitudes towards people living with dementia, person-centred approaches to care planning, developing skills to provide tailored and flexible care, regular contact, family engagement and usability of assistive devices. A general metamechanism that emerges concerns the synergy between an intervention strategy, the dementia trajectory and social and environmental factors, especially family involvement. A flexible service model for people with dementia and diabetes would enable this synergy in a way that would lead to the improved management of diabetes in people living with dementia. LIMITATIONS: There is little evidence relating to the management of diabetes in people living with dementia, although including a wider literature provided opportunities for transferable learning. The outcomes in our CMOs are largely experiential rather than clinical. This reflects the evidence available. Outcomes such as increased engagement in self-management are potential surrogates for better clinical management of diabetes, but this is not proven. CONCLUSIONS: This review suggests that there is a need to prioritise quality of life, independence and patient and carer priorities over a more biomedical, target-driven approach. Much current research, particularly that specific to people living with dementia and diabetes, identifies deficiencies in, and problems with, current systems. Although we have highlighted the need for personalised care, continuity and family-centred approaches, there is much evidence to suggest that this is not currently happening. Future research on the management of diabetes in older people with complex health needs, including those with dementia, needs to look at how organisational structures and workforce development can be better aligned to the needs of people living with dementia and diabetes. STUDY REGISTRATION: This study is registered as PROSPERO CRD42015020625. FUNDING: The NIHR HTA programme.