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Background: Cardiovascular disease is responsible for 31% of all global deaths. Primary prevention strategies are needed to improve longer-term adherence to statins and healthy lifestyle behaviours to reduce risk in people at risk of cardiovascular disease.Methods: Pragmatic randomised controlled trial recruited between May 2016 and March 2017 from primary care practices, England. Participants (n = 212) prescribed statins for primary prevention of cardiovascular disease with total cholesterol level ≥ 5 mmol/l were randomised: 105 to the intervention group and 107 to the control group, stratified by age and sex. The 3R intervention involved two facilitated, structured group education sessions focusing on medication adherence to statins, lifestyle behaviours and cardiovascular risk, with 44 weeks of medication reminders and motivational text messages and two supportive, coaching phone calls (at approximately 2 weeks and 6 months). The control group continued with usual clinical care. Both groups received a basic information leaflet. The primary outcome was medication adherence to statins objectively measured by a biochemical urine test. Self-reported adherence and practice prescription data provided additional measures. Secondary outcomes included cholesterol profile, blood pressure, anthropometric data, cardiovascular risk score, and self-reported lifestyle behaviours and psychological measures (health/medication beliefs, quality of life, health status). All outcomes were assessed at 12 months.Results: Baseline adherence to statins was 47% (control) and 62% (intervention). No significant difference between the groups found for medication adherence to statins using either the urine test (OR 1.02, 95% CI 0.34 to 3.06, P = 0.968) or other measures. This may have been due to the higher than expected adherence levels at baseline. The adjusted mean difference between the groups (in favour of the intervention group) for diastolic blood pressure (- 4.28 mmHg (95% CI - 0.98 to - 1.58, P = 0.002)) and waist circumference (- 2.55 cm (95% CI - 4.55 to - 0.55, P = 0.012)). The intervention group also showed greater perceived control of treatment and more coherent understanding of the condition.Conclusions: The 3R programme successfully led to longer-term improvements in important clinical lifestyle indicators but no improvement in medication adherence, raising questions about the suitability of such a broad, multiple risk factor approach for improving medication adherence for primary prevention of CVD.Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN16863160), March 11, 2006. [ABSTRACT FROM AUTHOR]

Background: The Diabetes Education and Self-Management for Ongoing and Newly Diagnosed (DESMOND) Self-monitoring Trial reported that people with newly diagnosed type 2 diabetes attending community-based structured education and randomized to self-monitoring of blood glucose (SMBG) or urine monitoring had comparable improvements in biomedical outcomes, but differences in satisfaction with, and continued use of monitoring method, well-being and perceived threat from diabetes.Objectives: To explore experiences of SMBG and urine monitoring following structured education. We specifically addressed the perceived usefulness of each monitoring method and the associated well-being.Methods: Qualitative semi-structured interviews with 18 adults with newly diagnosed type 2 diabetes participating in the DESMOND Self-monitoring Trial (SMBG, N=10; urine monitoring, N=8)~12 months into the trial. Analysis was informed by the constant comparative approach.Results: Interviewees reported SMBG as accurate, convenient and useful. Declining use was explained by having established a pattern of managing blood glucose with less frequent monitoring or lack of feedback or encouragement from health care professionals. Many initially positive views of urine monitoring progressively changed due to perceived inaccuracy, leading some to switch to SMBG. Perceiving diabetes as less serious was attributable to lack of symptoms, treatment with diet alone and-in the urine-monitoring group-consistently negative readings. Urine monitoring also provided less visible evidence of diabetes and of the effect of behaviour on glucose.Conclusions: The findings highlight the importance for professionals of considering patients' preferences when using self-monitoring technologies, including how these change over time, when supporting the self-care behaviours of people with type 2 diabetes. [ABSTRACT FROM AUTHOR]

Background In trials of behavioural interventions, the individuals who deliver the intervention are in a position of key influence on the success of the trial. Their fidelity to the intervention is crucial. Yet little is understood about the experiences of this group of trial personnel. This study aimed to investigate the views and experiences of educators who delivered a structured education intervention to people with type 2 diabetes, which incorporated training in selfmonitoring of either blood glucose (SMBG) or urine glucose (SMUG) as part of a randomized controlled trial (RCT). Methods Educators' views were explored through focus groups before and after training (N = 18) and approximately 1 year into the trial (N = 14), and semi-structured telephone interviews at approximately 2 years (N = 7). Analysis was based on the constant comparative method. Results Educators held preferences regarding the intervention variants; thus, they were not in individual equipoise. Training raised awareness of preferences and their potential to impact on delivery. Educators were confident in their unbiased delivery, but acknowledged the challenges involved. Concealing their preferences was helped by a sense of professionalism, the patient-centred nature of the intervention, and concessions in the trial protocol (enabling participants to swap monitoring methods if needed). Commitment to unbiased delivery was explained through a desire for evidence-based knowledge in the contentious area of SMBG. Conclusions The findings provide insight into a previously unexplored group of trial personnel - intervention deliverers in trials of behavioural interventions - which will be useful to those designing and running similar trials. Rather than individual equipoise, it is intervention deliverers' awareness of personal preferences and their potential impact on the trial outcome that facilitates unbiased delivery. Further, awareness of community equipoise, the need for evidence, and relevance to the individual enhance commitment to the RCT. Trial registration ISRCTN95696668 [ABSTRACT FROM AUTHOR]

Background: In trials of behavioural interventions, the individuals who deliver the intervention are in a position of key influence on the success of the trial. Their fidelity to the intervention is crucial. Yet little is understood about the experiences of this group of trial personnel. This study aimed to investigate the views and experiences of educators who delivered a structured education intervention to people with type 2 diabetes, which incorporated training in self-monitoring of either blood glucose (SMBG) or urine glucose (SMUG) as part of a randomized controlled trial (RCT).Methods: Educators' views were explored through focus groups before and after training (N=18) and approximately 1 year into the trial (N=14), and semi-structured telephone interviews at approximately 2 years (N=7). Analysis was based on the constant comparative method.Results: Educators held preferences regarding the intervention variants; thus, they were not in individual equipoise. Training raised awareness of preferences and their potential to impact on delivery. Educators were confident in their unbiased delivery, but acknowledged the challenges involved. Concealing their preferences was helped by a sense of professionalism, the patient-centred nature of the intervention, and concessions in the trial protocol (enabling participants to swap monitoring methods if needed). Commitment to unbiased delivery was explained through a desire for evidence-based knowledge in the contentious area of SMBG.Conclusions: The findings provide insight into a previously unexplored group of trial personnel--intervention deliverers in trials of behavioural interventions--which will be useful to those designing and running similar trials. Rather than individual equipoise, it is intervention deliverers' awareness of personal preferences and their potential impact on the trial outcome that facilitates unbiased delivery. Further, awareness of community equipoise, the need for evidence, and relevance to the individual enhance commitment to the RCT.Trial Registration: ISRCTN95696668. [ABSTRACT FROM AUTHOR]

Objective: to identify predictive morbidities for urinary storage syndromes including indicators for neurological, musculoskeletal, cardiovascular, immune, lower bowel and psychological systems. This is the first study to test prior hypotheses, based on a literature review. Design: this was a prospective cohort study involving 12,570 female respondents aged 40 or more registered with general practitioners and living at home in Leicestershire. Postal questionnaires were used at baseline and 1-year follow-up (response rates 65 and 79%, respectively). Measures: pure stress urinary incontinence (SUI) and overactive bladder syndrome (OAB) were defined using standardised symptom indicators. Specific morbidities included reported medical diagnoses, standardised symptoms and general health indicators. Associations were identified using logistic regression, adjusting for age and physical impairment, with separate models for general and specific morbidities. Results: multivariate morbidities consistently associated (i.e. both longitudinally and cross-sectionally) were SUI--cystitis and obesity; and OAB--bowel urgency, osteoporosis, imbalance, ankle swelling, cystitis, poor health and old age. Other independent predictors were SUI--multiple sclerosis and joint pain; and OAB--deep vein thrombosis and diabetes. Consistent univariate indicators supported neurological, musculoskeletal, cardiovascular, immunological and psychological connections with both types of storage disorder plus an association with lower bowel problems for OAB. Conclusions: abnormal urinary storage symptoms were predicted by obesity and poor general health, involving a range of systems of the body. OAB showed more extensive links than SUI with specific morbidities, including more medically diagnosed as opposed to symptom-based conditions. These findings were independent of problems with physical impairment. [ABSTRACT FROM AUTHOR]

Objective: To investigate associations between diet and non-dietary lifestyle factors and the onset of overactive bladder (OAB) in men.Subjects: Random sample of community-dwelling men aged 40 years plus.Design and Methods: Baseline data on urinary symptoms and diet were collected from 5454 men using a postal questionnaire and a food-frequency questionnaire. Follow-up data on urinary symptoms were collected from 4887 men in a postal survey one year later. Logistic regression analysis was used to investigate diet and lifestyle factors associated with onset of OAB in the men without OAB at baseline.Results: There was a highly significant negative association between beer intake at baseline and subsequent OAB onset (P=0.001), with reduced risk at all levels of intake compared with those who seldom/never drank beer. Adjustment for total alcohol intake (g ethanol day(-1)) reduced the significance of the association (P=0.02). None of the food groups studied was associated with OAB onset, with the possible exception of potatoes (P=0.05), which showed an increased risk of onset at the highest level of consumption. Physical activity, smoking and obesity were not significantly associated.Conclusions: While most diet and lifestyle factors were not associated with OAB onset, the evidence from this prospective longitudinal study suggests that beer may have a protective role in the development of OAB. This could be due to a non-alcoholic ingredient as well as the alcohol content. [ABSTRACT FROM AUTHOR]