\u00a9 Jinshuo Li, Steve Parrott, Michael Sweeting, Andrew Farmer, Jamie Ross, Charlotte Dack, Kingshuk Pal, Lucy Yardley, Maria Barnard, Mohammed Hudda, Ghadah Alkhaldi, Elizabeth Murray. Background: Type 2 diabetes mellitus is one of the most common long-term conditions, and costs health services approximately 10% of their total budget. Active self-management by patients improves outcomes and reduces health service costs. While the existing evidence suggested that uptake of self-management education was low, the development of internet-based technology might improve the situation. Objective: To establish the cost-effectiveness of a Web-based self-management program for people with type 2 diabetes (HeLP-Diabetes) compared to usual care. Methods: An incremental cost-effectiveness analysis was conducted, from a National Health Service and personal and social services perspective, based on data collected from a multi-center, two-arm individually randomized controlled trial over 12 months. Adults aged 18 or over with a diagnosis of type 2 diabetes and registered with the 21 participating general practices (primary care) in England, UK, were approached. People who were unable to provide informed consent or to use the intervention, terminally ill, or currently participating in a trial of an alternative self-management intervention, were excluded. The participants were then randomized to either usual care plus HeLP-Diabetes, an interactive, theoretically-informed Web-based self-management program, or to usual care plus access to a comparator website containing basic information only. The participants\u2019 intervention costs and wider health care resource use were collected as well as two health-related quality of life measures: the Problem Areas in Diabetes (PAID) Scale and EQ-5D-3L. EQ-5D-3L was then used to calculate quality-adjusted life years (QALYs). The primary analysis was based on intention-to-treat, using multiple imputation to handle the missing data. Results: In total, 374 participants were randomized, with 185 in the intervention group and 189 in the control group. The primary analysis showed incremental cost-effectiveness ratios of \u00a358 (95% CI \u2013411 to 587) per unit improvement on PAID scale and \u00a35550 (95% CI \u201321,077 to 52,356) per QALY gained by HeLP-Diabetes, compared to the control. The complete case analysis showed less cost-effectiveness and higher uncertainty with incremental cost-effectiveness ratios of \u00a3116 (95% CI \u20131299 to 1690) per unit improvement on PAID scale and \u00a318,500 (95% CI \u2013203,949 to 190,267) per QALY. The cost-effectiveness acceptability curve showed an 87% probability of cost-effectiveness at \u00a320,000 per QALY willingness-to-pay threshold. The one-way sensitivity analyses estimated 363 users would be needed to use the intervention for it to become less costly than usual care. Conclusions: Facilitated access to HeLP-Diabetes is cost-effective, compared to usual care, under the recommended threshold of \u00a320,000 to \u00a330,000 per QALY by National Institute of Health and Care Excellence. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 02123133; http://www.controlled-trials.com/ISRCTN02123133 (Archived by WebCite at http://www.webcitation.org/6zqjhmn00)
\n \n\n \n \n\u00a9 Lucy Mackillop, Jane Elizabeth Hirst, Katy Jane Bartlett, Jacqueline Susan Birks, Lei Clifton, Andrew J Farmer, Oliver Gibson, Yvonne Kenworthy, Jonathan Cummings Levy, Lise Loerup, Oliver Rivero-Arias, Wai-Kit Ming, Carmelo Velardo, Lionel Tarassenko. Background: Treatment of hyperglycemia in women with gestational diabetes mellitus (GDM) is associated with improved maternal and neonatal outcomes and requires intensive clinical input. This is currently achieved by hospital clinic attendance every 2 to 4 weeks with limited opportunity for intervention between these visits. Objective: We conducted a randomized controlled trial to determine whether the use of a mobile phone-based real-time blood glucose management system to manage women with GDM remotely was as effective in controlling blood glucose as standard care through clinic attendance. Methods: Women with an abnormal oral glucose tolerance test before 34 completed weeks of gestation were individually randomized to a mobile phone-based blood glucose management solution (GDm-health, the intervention) or routine clinic care. The primary outcome was change in mean blood glucose in each group from recruitment to delivery, calculated with adjustments made for number of blood glucose measurements, proportion of preprandial and postprandial readings, baseline characteristics, and length of time in the study. Results: A total of 203 women were randomized. Blood glucose data were available for 98 intervention and 85 control women. There was no significant difference in rate of change of blood glucose (\u20130.16 mmol/L in the intervention and \u20130.14 mmol/L in the control group per 28 days, P=.78). Women using the intervention had higher satisfaction with care (P=.049). Preterm birth was less common in the intervention group (5/101, 5.0% vs 13/102, 12.7%; OR 0.36, 95% CI 0.12-1.01). There were fewer cesarean deliveries compared with vaginal deliveries in the intervention group (27/101, 26.7% vs 47/102, 46.1%, P=.005). Other glycemic, maternal, and neonatal outcomes were similar in both groups. The median time from recruitment to delivery was similar (intervention: 54 days; control: 49 days; P=.23). However, there were significantly more blood glucose readings in the intervention group (mean 3.80 [SD 1.80] and mean 2.63 [SD 1.71] readings per day in the intervention and control groups, respectively; P<.001). There was no significant difference in direct health care costs between the two groups, with a mean cost difference of the intervention group compared to control of \u2013\u00a31044 (95% CI \u2013\u00a32186 to \u00a399). There were no unexpected adverse outcomes. Conclusions: Remote blood glucocse monitoring in women with GDM is safe. We demonstrated superior data capture using GDm-health. Although glycemic control and maternal and neonatal outcomes were similar, women preferred this model of care. Further studies are required to explore whether digital health solutions can promote desired self-management lifestyle behaviors and dietetic adherence, and influence maternal and neonatal outcomes. Digital blood glucose monitoring may provide a scalable, practical method to address the growing burden of GDM around the world.
\n \n\n \n \n\u00a9 Hannah Long, Yvonne K Bartlett, Andrew J Farmer, David P French. Background: Current interventions to support medication adherence in people with type 2 diabetes are generally resource-intensive and ineffective. Brief messages, such as those delivered via short message service (SMS) systems, are increasingly used in digital health interventions to support adherence because they can be delivered on a wide scale and at low cost. The content of SMS text messages is a crucial intervention feature for promoting behavior change, but it is often unclear what the rationale is for chosen wording or any underlying mechanisms targeted for behavioral change. There is little guidance for developing and optimizing brief message content for use in mobile device\u2013delivered interventions. Objective: This review aimed to (1) identify theoretical constructs (ie, the targets that interventions aim to change) and behavioral strategies (ie, features of intervention content) found to be associated with medication adherence in patients with type 2 diabetes and (2) map these onto a standard taxonomy for behavior change techniques (BCTs, that is, active ingredients of interventions used to promote behavioral change, to produce an evidence-based set of approaches that have shown promise of improving adherence in previous studies and which could be further tested in digital health interventions. Methods: A rapid systematic review of existing relevant systematic reviews was conducted. MEDLINE and PsycINFO databases were searched from inception to April 10, 2017. Inclusion criteria were (1) systematic reviews of quantitative data if the studies reviewed identified predictors of or correlates with medication adherence or evaluated medication adherence\u2013enhancing interventions and included adult participants taking medication to manage a chronic physical health condition, and (2) systematic reviews of qualitative studies of experiences of medication adherence for adult participants with type 2 diabetes. Data were extracted on review characteristics and BCTs, theoretical constructs, or behavioral strategies associated with improved adherence. Constructs and strategies were mapped onto the BCT version 1 taxonomy. Results: A total of 1701 references were identified; 25 systematic reviews (19 quantitative reviews, 3 qualitative reviews, and 3 mixed-method reviews) were included. Moreover, 20 theoretical constructs (eg, self-efficacy) and 19 behavioral strategies (eg, habit analysis) were identified in the included reviews. In total, 46 BCTs were identified as being related to medication adherence in type 2 diabetes (eg, habit formation, prompts or cues, and information about health consequences). Conclusions: We identified 46 promising BCTs related to medication adherence in type 2 diabetes on which the content of brief messages delivered through mobile devices to improve adherence could be based. By using explicit systematic review methods and linking our findings to a standardized taxonomy of BCTs, we have described a novel approach for the development of digital message content. Future brief message interventions that aim to support medication adherence could incorporate the identified BCTs.
\n \n\n \n \n\u00a9 2018 Cooper et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Introduction Sexual dysfunction is a common complication for men with diabetes, yet little is known about the lived experiences of sexual difficulties within the context of diabetes, particularly in low-and-middle-income countries. This study explores how men with type 2 diabetes in three sub-Saharan African settings (Cape Town and Johannesburg, South Africa; Lilongwe, Malawi) perceive and experience sexual functioning and sexual well-being, and the biopsychosocial contexts in which these occur and are shaped. Methods We used a qualitative research design, including individual interviews (n = 15) and focus group discussions (n = 4). Forty-seven men were included in the study. We used an inductive thematic analysis approach to develop our findings. A biopsychosocial conceptual model on the relationship between chronic illness and sexuality informed the interpretation of findings. Results Men across the study settings identified sexual difficulties as a central concern of living with diabetes. These difficulties went beyond biomedical issues of erectile dysfunction, comprising complex psychological and relational effects. Low self-esteem, related to a sense of loss of masculinity and reduced sexual and emotional intimacy in partner relationships were common experiences. Specific negative relational effects included suspicion of infidelity, mutual mistrust, general unhappiness, and fear of losing support from partners. These effects may impact on men\u2019s ability to cope with their diabetes. Further stressors were a lack of information about the reasons for their sexual difficulties, perceived lack of support from healthcare providers and an inability to communicate with partners about sexual difficulties. Conclusion More in-depth research is needed to better understand sexual functioning and well-being within the context of diabetes, and its potential impact on diabetes self-management. Holistic and patient-centered care should include raising awareness of sexual problems as a potential complication of diabetes amongst patients, their partners and care providers, and incorporating sexual well-being as part of routine clinical care.
\n \n\n \n \nBACKGROUND: In response to concerns that the International Association of Diabetes in Pregnancy Study Group (IADPSG) criteria labeled too many women with gestational diabetes mellitus (GDM) without evidence of clinical or economic benefit, NICE recommended a change in diagnostic criteria in 2015. AIM: To compare diabetes associated maternal and neonatal complications in pregnancies complicated by GDM diagnosed using IADPSG criteria only, to those with GDM diagnosed using both IADPSG and NICE 2015 criteria. GDM screening was risk factor based. METHODS: This was a secondary analysis of a trial of women with GDM diagnosed by the IADPSG criteria (fasting blood glucose (BG) \u2265 5.1 mmol/L, 1 h \u2265 10.0 mmol/L and 2 h \u2265 8.5 mmol/L). Outcomes were compared for two groups: NICE + IADPSG defined as those with GDM diagnosed by both the NICE 2015 and IADPSG criteria (fasting BG \u2265 5.6 mmol/L, 2 h \u2265 8.5 mmol/L); and IADPSG-ONLY (fasting BG 5.1 mmol/L to 5.5 mmol/L, and/or 1-hour \u226510.0 mmol/L, and 2 h \u2265 8.5 mmol/L). We were not able to obtain data for women with a 2-h value between BG 7.8\u207b8.4 mmol/L (i.e., NICE-ONLY; NICE 2015 positive and IADPSG negative). All women were treated for GDM using targets of fasting BG < 5.3 mmol/L and 1-h post prandial BG < 7.8 mmol/L respectively. RESULTS: Of 159 women, 65 (40.9%) were NICE + IADPSG and 94 (59.1%) IADPSG-ONLY. Hypoglycaemic medication use was similar in both groups: 52.3% NICE + IADPSG, 46.8% IADPSG-ONLY, OR 1.0 (0.5\u207b1.9). The IADPSG-ONLY group delivered later than the NICE + IADPSG group; 39.0 weeks (sd 1.4) compared to 38.2 weeks (sd 2.5), p value 0.02. Fewer caesarean sections occurred in IADPSG-ONLY group 30.9% vs. 52.3%, OR 0.4 (0.2\u207b0.9). Birthweight, large for gestational age, and other neonatal complications were not significantly different between groups. CONCLUSIONS: Gestational diabetes-associated perinatal complications were similar in both groups. The IADPSG criteria detect women with evidence of ongoing hyperglycaemia who may benefit from treatment during pregnancy.
\n \n\n \n \n\u00a9 2018 Massachusetts Medical Society. Background: Increased intake of n-3 fatty acids has been associated with a reduced risk of cardiovascular disease in observational studies, but this finding has not been confirmed in randomized trials. It remains unclear whether n-3 (also called omega-3) fatty acid supplementation has cardiovascular benefit in patients with diabetes mellitus. Methods: We randomly assigned 15,480 patients with diabetes but without evidence of atherosclerotic cardiovascular disease to receive 1-g capsules containing either n-3 fatty acids (fatty acid group) or matching placebo (olive oil) daily. The primary outcome was a first serious vascular event (i.e., nonfatal myocardial infarction or stroke, transient ischemic attack, or vascular death, excluding confirmed intracranial hemorrhage). The secondary outcome was a first serious vascular event or any arterial revascularization. Results: During a mean follow-up of 7.4 years (adherence rate, 76%), a serious vascular event occurred in 689 patients (8.9%) in the fatty acid group and in 712 (9.2%) in the placebo group (rate ratio, 0.97; 95% confidence interval [CI], 0.87 to 1.08; P = 0.55). The composite outcome of a serious vascular event or revascularization occurred in 882 patients (11.4%) and 887 patients (11.5%), respectively (rate ratio, 1.00; 95% CI, 0.91 to 1.09). Death from any cause occurred in 752 patients (9.7%) in the fatty acid group and in 788 (10.2%) in the placebo group (rate ratio, 0.95; 95% CI, 0.86 to 1.05). There were no significant between-group differences in the rates of nonfatal serious adverse events. Conclusions: Among patients with diabetes without evidence of cardiovascular disease, there was no significant difference in the risk of serious vascular events between those who were assigned to receive n-3 fatty acid supplementation and those who were assigned to receive placebo.
\n \n\n \n \n\u00a9 2018 Massachusetts Medical Society. Background: Diabetes mellitus is associated with an increased risk of cardiovascular events. Aspirin use reduces the risk of occlusive vascular events but increases the risk of bleeding; the balance of benefits and hazards for the prevention of first cardiovascular events in patients with diabetes is unclear. Methods: We randomly assigned adults who had diabetes but no evident cardiovascular disease to receive aspirin at a dose of 100 mg daily or matching placebo. The primary efficacy outcome was the first serious vascular event (i.e., myocardial infarction, stroke or transient ischemic attack, or death from any vascular cause, excluding any confirmed intracranial hemorrhage). The primary safety outcome was the first major bleeding event (i.e., intracranial hemorrhage, sight-threatening bleeding event in the eye, gastrointestinal bleeding, or other serious bleeding). Secondary outcomes included gastrointestinal tract cancer. Results: A total of 15,480 participants underwent randomization. During a mean follow-up of 7.4 years, serious vascular events occurred in a significantly lower percentage of participants in the aspirin group than in the placebo group (658 participants [8.5%] vs. 743 [9.6%]; rate ratio, 0.88; 95% confidence interval [CI], 0.79 to 0.97; P = 0.01). In contrast, major bleeding events occurred in 314 participants (4.1%) in the aspirin group, as compared with 245 (3.2%) in the placebo group (rate ratio, 1.29; 95% CI, 1.09 to 1.52; P = 0.003), with most of the excess being gastrointestinal bleeding and other extracranial bleeding. There was no significant difference between the aspirin group and the placebo group in the incidence of gastrointestinal tract cancer (157 participants [2.0%] and 158 [2.0%], respectively) or all cancers (897 [11.6%] and 887 [11.5%]); long-term follow-up for these outcomes is planned. Conclusions: Aspirin use prevented serious vascular events in persons who had diabetes and no evident cardiovascular disease at trial entry, but it also caused major bleeding events. The absolute benefits were largely counterbalanced by the bleeding hazard.
\n \n\n \n \nTo review published studies on the effect of diabetes and its complications on utility scores to establish whether there is systematic variation across studies and to examine the implications for the estimation of quality-adjusted life years (QALYs). A systematic review was performed using studies reporting QALY measures elicited from people with diabetes including those with a history of complications. Meta-analysis was used to obtain the average utility, and meta-regression was employed to examine the impact of study characteristics and elicitation methods on these values. The effect of different utility scores on QALYs was examined using diabetes simulation models. In the meta-analysis based on 45 studies reporting 66 values, the average utility score was 0.76 (95% CI 0.75-0.77). A meta-regression showed significant variation due to age, method of elicitation and the proportion of males. The average utility score for individual complications ranged from 0.48 (95% CI 0.25, 0.71) for chronic renal disease to 0.75 (95% CI 0.73, 0.78) for myocardial infarction, and these differences produced meaningful changes in simulated QALYs. There was significant heterogeneity between studies. We provide summary utility scores for diabetes and its major complications that could help inform economic evaluation and policy analysis. \u00a9 2011 Springer Science+Business Media B.V.
\n \n\n \n \n\u00a9 2016 Diabetes UK Aims: To explore patients' perceptions and experiences of taking oral medications for the pharmacological management of Type 2 diabetes mellitus. Methods: Cinahl, EMBASE, Medline and PsycINFO databases were searched in 2014 to identify qualitative studies exploring patients' perceptions or experiences of taking medications for the management of Type 2 diabetes. Key concepts and themes were extracted and synthesized using meta-ethnography. Results: Eight studies were included. Primary study findings were synthesized to develop three higher-order constructs that moved beyond the results of individual studies. The first construct, Medications for diabetes: a necessary evil, outlines how patients' negative perceptions of medication risks co-exist with a resounding view that medications are beneficial. Passive patients but active experimenters highlights the contrast between patients' passive acceptance of medication prescriptions and the urge to actively experiment and adjust doses to optimize medication use in daily life. Finally, Taking oral medication for Type 2 diabetes: a unique context describes features specific to the Type 2 diabetes medication experience, including lack of symptoms and the perceived relationship between medication and diet, which may influence adherence. Conclusions: Medication-taking for Type 2 diabetes is a unique adherence context, which requires the development of condition-specific interventions. The present findings indicate patients understand the need for medications but adjust dosage and timing in their daily lives. This review suggests providers should acknowledge patient preferences in the development of management strategies, and highlights an opportunity to direct the motivation evident in patients' experimentation towards potentially more beneficial medication-taking behaviours.
\n \n\n \n \n\u00a9 2015 Murray et al. Background: Type 2 Diabetes Mellitus (T2DM) is common, affecting nearly 400 million people worldwide. Achieving good health for people with T2DM requires active self-management; however, uptake of self-management education is poor, and there is an urgent need to find better, more acceptable, cost-effective methods of providing self-management support. Web-based self-management support has many potential benefits for patients and health services. The aim of this trial is to determine the effectiveness and cost-effectiveness of a web-based self-management support programme for people with T2DM. Methods: This will be a multi-centre individually randomised controlled trial in primary care, recruiting adults with T2DM who are registered with participating general practices in England. Participants will be randomised to receive either an evidence-based, theoretically informed, web-based self-management programme for people with T2DM which addresses medical, emotional, and role management, called Healthy Living for People with type 2 Diabetes (HeLP-Diabetes) or a simple information website. The joint primary outcomes are glycated haemoglobin (HbA1c) and diabetes-related distress, measured by the Problem Areas In Diabetes (PAID) questionnaire. Secondary outcomes include cardiovascular risk factors, depression and anxiety, and self-efficacy for self-management of diabetes. Health economic data include health service use, costs due to the intervention, and EQ-5D for calculation of Quality Adjusted Life Years (QALYS). Data will be collected at baseline, 3 months and 12 months, with the primary endpoint at 12 months. Practice nurses, blinded to patient allocation, collect clinical data; patients complete online questionnaires for patient reported measures. A sample size of 350 recruited participants allows for attrition of up to 15 % and will provide 90 % power of detecting at a 5 % significance level a true average difference in the PAID score of 4.0 and 0.25 % change in HbA1c (both small effect sizes). The analysis will follow a pre-specified analysis plan, based on comparing the groups as randomised (intention-to-treat). Discussion: The findings of this trial are likely to be of interest to policy makers, clinicians, and commissioners, all of whom are actively seeking additional forms of self-management support for people with T2DM. Trial registration: The Trial Registration number is ISRCTN 02123133; date of registration 14.2.13.
\n \n\n \n \n\u00a9 The Author 2016. Background Valvular heart disease (VHD) is expected to become more common as the population ages. However, current estimates of its natural history and prevalence are based on historical studies with potential sources of bias.We conducted a cross-sectional analysis of the clinical and epidemiological characteristics of VHD identified at recruitment of a large cohort of older people. Methods and results We enrolled 2500 individuals aged \u226565 years from a primary care population and screened for undiagnosed VHD using transthoracic echocardiography. Newly identified (predominantly mild) VHD was detected in 51% of participants. The most common abnormalities were aortic sclerosis (34%), mitral regurgitation (22%), and aortic regurgitation (15%). Aortic stenosis was present in 1.3%. The likelihood of undiagnosed VHD was two-fold higher in the two most deprived socioeconomic quintiles than in the most affluent quintile, and three-fold higher in individuals with atrial fibrillation. Clinically significant (moderate or severe) undiagnosed VHD was identified in 6.4%. In addition, 4.9% of the cohort had pre-existing VHD (a total prevalence of 11.3%). Projecting these findings using population data, we estimate that the prevalence of clinically significant VHD will double before 2050. Conclusions Previously undetected VHD affects 1 in 2 of the elderly population and is more common in lower socioeconomic classes. These unique data demonstrate the contemporary clinical and epidemiological characteristics of VHD in a large population-based cohort of older people and confirm the scale of the emerging epidemic of VHD, with widespread implications for clinicians and healthcare resources.
\n \n\n \n \n\u00a9 2016 Elsevier Ireland Ltd Aims Clinical trial patients are highly motivated but may encounter difficulty in taking study medication regularly when treatment burden is substantial. We assessed a brief behavioural intervention, given in addition to a standard trial protocol. Methods We performed a two-arm adherence sub-study within a twelve-month randomised controlled drug trial evaluating the impact of statin and/or omega-3 EE90 treatment in 800 patients with type 2 diabetes. Fifty-nine United Kingdom general practices were cluster-randomised to action-planning or control groups. The former delivered an initial written exercise prompting participants to formulate action-plans to take study medication regularly, with brief nurse encouragement to use action-plans at later visits, whilst the latter followed the standard trial protocol. The primary outcome was proportion of days on which study medication were taken as intended measured by electronic medication containers. Results Adjusted mean (95% CI) proportion of days with medication taken as intended was 79.3% (76.3\u201382.3%) for the 30 action-planning practices (321 participants), compared with 78.5% (75.8\u201381.1%) for 27 control group practices (426 participants, with a mean intervention effect of 0.9%, 95% CI \u22123.1% to +4.9%, p = 0.67). Adjusted odds ratios for \u2a7e80% trial medication adherence for action-planning compared with control practices were 1.29 (0.90\u20131.84) and 1.38 (0.96\u20131.99) respectively. Conclusions Low-intensity action-planning interventions used alone are unlikely to have a clinically important impact on medication adherence, particularly in a clinical trial setting. These findings, do not exclude their contribution, as part of a multifactorial intervention, to improving treatment adherence. ISRCTN number 76737502.
\n \n\n \n \n\u00a9 2016 Macmillan Publishers Limited, part of Springer Nature. All rights reserved. The genetic architecture of common traits, including the number, frequency, and effect sizes of inherited variants that contribute to individual risk, has been long debated. Genome-wide association studies have identified scores of common variants associated with type 2 diabetes, but in aggregate, these explain only a fraction of the heritability of this disease. Here, to test the hypothesis that lower-frequency variants explain much of the remainder, the GoT2D and T2D-GENES consortia performed whole-genome sequencing in 2,657 European individuals with and without diabetes, and exome sequencing in 12,940 individuals from five ancestry groups. To increase statistical power, we expanded the sample size via genotyping and imputation in a further 111,548 subjects. Variants associated with type 2 diabetes after sequencing were overwhelmingly common and most fell within regions previously identified by genome-wide association studies. Comprehensive enumeration of sequence variation is necessary to identify functional alleles that provide important clues to disease pathophysiology, but large-scale sequencing does not support the idea that lower-frequency variants have a major role in predisposition to type 2 diabetes.
\n \n\n \n \nProfessional bodies have produced comprehensive guidance about the management of hip fracture. They recommend orthogeriatric services focusing on achieving optimal recovery, and fracture liaison services (FLSs) focusing on secondary fracture prevention. Despite such guidelines being in place, there is significant variation in how services are structured and organised between hospitals.To establish the clinical effectiveness and cost-effectiveness of changes to the delivery of secondary fracture prevention services, and to identify barriers and facilitators to changes.A service evaluation to identify each hospital\u2019s current models of care and changes in service delivery. A qualitative study to identify barriers and facilitators to change. Health economics analysis to establish NHS costs and cost-effectiveness. A natural experimental study to determine clinical effectiveness of changes to a hospital\u2019s model of care.Eleven acute hospitals in a region of England.Qualitative study \u2013 43 health professionals working in fracture prevention services in secondary care.Changes made to secondary fracture prevention services at each hospital between 2003 and 2012.The primary outcome is secondary hip fracture. Secondary outcomes include mortality, non-hip fragility fracture and the overall rate of hip fracture.Clinical effectiveness/cost-effectiveness analyses \u2013 primary hip fracture patients identified from (1) Hospital Episode Statistics (2003\u201313, n\u2009=\u200933,152); and (2) Clinical Practice Research Datalink (1999\u20132013, n\u2009=\u200911,243).Service evaluation \u2013 there was significant variation in the organisation of secondary fracture prevention services, including staffing levels, type of service model (consultant vs. nurse led) and underlying processes. Qualitative \u2013 fracture prevention co-ordinators gave multidisciplinary health professionals capacity to work together, but communication with general practitioners was challenging. The intervention was easily integrated into practice but some participants felt that implementation was undermined by under-resourced services. Making business cases for a service was particularly challenging. Natural experiment \u2013 the impact of introducing an orthogeriatrician on 30-day and 1-year mortality was hazard ratio (HR) 0.73 [95% confidence interval (CI) 0.65 to 0.82] and HR 0.81 (95% CI 0.75 to 0.87), respectively. Thirty-day and 1-year mortality were likewise reduced following the introduction or expansion of a FLS: HR 0.80 (95% CI 0.71 to 0.91) and HR 0.84 (95% CI 0.77 to 0.93), respectively. There was no significant impact on time to secondary hip fracture. Health economics \u2013 the annual cost in the year of hip fracture was estimated at \u00a310,964 (95% CI \u00a310,767 to \u00a311,161) higher than the previous year. The annual cost associated with all incident hip fractures in the UK among those aged \u2265\u200950 years (n\u2009=\u200979,243) was estimated at \u00a31215M. At a \u00a330,000 per quality-adjusted life-year threshold, the most cost-effective model was introducing an orthogeriatrician.In hip fracture patients, orthogeriatrician and nurse-led FLS models are associated with reductions in mortality rates and are cost-effective, the orthogeriatrician model being the most cost-effective. There was no evidence for a reduction in second hip fracture. Qualitative data suggest that weaknesses lie in treatment adherence/monitoring, a possible reason for the lack of effectiveness on second hip fracture outcome. The effectiveness on non-hip fracture outcomes remains unanswered.Reliable estimates of health state utility values for patients with hip and non-hip fractures are required to reduce uncertainty in health economic models. A clinical trial is needed to assess the clinical effectiveness and cost-effectiveness of a FLS for non-hip fracture patients.The National Institute for Health Research (NIHR) Health Services and Delivery Research programme and the NIHR Musculoskeletal Biomedical Research Unit, University of Oxford.
\n \n\n \n \n\u00a9 Wai-Kit Ming, Lucy H Mackillop, Andrew J Farmer, Lise Loerup, Katy Bartlett, Jonathan C Levy, Lionel Tarassenko, Carmelo Background: Diabetes in pregnancy is a global problem. Technological innovations present exciting opportunities for novel approaches to improve clinical care delivery for gestational and other forms of diabetes in pregnancy. Objective: To perform an updated and comprehensive systematic review and meta-analysis of the literature to determine whether telemedicine solutions offer any advantages compared with the standard care for women with diabetes in pregnancy. Methods: The review was developed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) framework. Randomized controlled trials (RCT) in women with diabetes in pregnancy that compared telemedicine blood glucose monitoring with the standard care were identified. Searches were performed in SCOPUS and PubMed, limited to English language publications between January 2000 and January 2016. Trials that met the eligibility criteria were scored for risk of bias using the Cochrane Collaborations Risk of Bias Tool. A meta-analysis was performed using Review Manager software version 5.3 (Nordic Cochrane Centre, Cochrane Collaboration). Results: A total of 7 trials were identified. Meta-analysis demonstrated a modest but statistically significant improvement in HbA1c associated with the use of a telemedicine technology. The mean HbA1c of women using telemedicine was 5.33% (SD 0.70) compared with 5.45% (SD 0.58) in the standard care group, representing a mean difference of -0.12% (95% CI -0.23% to -0.02%). When this comparison was limited to women with gestational diabetes mellitus (GDM) only, the mean HbA1c of women using telemedicine was 5.22% (SD 0.70) compared with 5.37% (SD 0.61) in the standard care group, mean difference -0.14% (95% CI -0.25% to -0.04%). There were no differences in other maternal and neonatal outcomes reported. Conclusions: There is currently insufficient evidence that telemedicine technology is superior to standard care for women with diabetes in pregnancy; however, there was no evidence of harm. No trials were identified that assessed patient satisfaction or cost of care delivery, and it may be in these areas where these technologies may be found most valuable.
\n \n\n \n \n\u00a9 Published by the BMJ Publishing Group Limited. Introduction Text message interventions have been shown to be effective in prevention and management of several non-communicable disease risk factors. However, the extent to which their effects might vary in different participants and settings is uncertain. We aim to conduct a systematic review and individual participant data (IPD) meta-analysis of randomised clinical trials examining text message interventions aimed to prevent cardiovascular diseases (CVD) through modification of cardiovascular risk factors (CVRFs). Methods and analysis Systematic review and IPD meta-analysis will be conducted according to Preferred Reporting Items for Systematic review and Meta-Analysis of IPD (PRISMA-IPD) guidelines. Electronic database of published studies (MEDLINE, EMBASE, PsycINFO and Cochrane Library) and international trial registries will be searched to identify relevant randomised clinical trials. Authors of studies meeting the inclusion criteria will be invited to join the IPD meta-analysis group and contribute study data to the common database. The primary outcome will be the difference between intervention and control groups in blood pressure at 6-month follow-up. Key secondary outcomes include effects on lipid parameters, body mass index, smoking levels and self-reported quality of life. If sufficient data is available, we will also analyse blood pressure and other secondary outcomes at 12 months. IPD meta-analysis will be performed using a one-step approach and modelling data simultaneously while accounting for the clustering of the participants within studies. This study will use the existing data to assess the effectiveness of text message-based interventions on CVRFs, the consistency of any effects by participant subgroups and across different healthcare settings. Ethics and dissemination Ethical approval was obtained for the individual studies by the trial investigators from relevant local ethics committees. This study will include anonymised data for secondary analysis and investigators will be asked to check that this is consistent with their existing approvals. Results will be disseminated via scientific forums including peer-reviewed publications and presentations at international conferences.
\n \n\n \n \n