Risk Reduction Research Articles

Prediabetes and cardiovascular risk factors: the effectiveness of a guided self-determination counselling approach in primary health care, a randomized controlled trial

BackgroundIdentify individuals who are at risk of Type 2 diabetes, who also are at a greater risk of developing cardiovascular disease is important. The rapid worldwide increase in diabetes prevalence call for Primary Health Care to find feasible prevention strategies, to reduce patient risk factors and promote lifestyle changes. Aim of this randomized controlled trial was to investigate how a nurse-lead Guided Self-Determination counselling approach can assist people at risk of type 2 diabetes to lower their coronary heart disease risk.MethodsIn this randomized controlled study, 81 people at risk of developing type 2 diabetes were assigned into an intervention group (n = 39) receiving Guided Self-Determination counselling from Primary Health Care nurses over three months and a control group (n = 42) that received a diet leaflet only. Measurements included the Finnish Diabetes Risk Score questionnaire and biological measurements of Hemoglobin A1c protein, Body Mass Index, fasting blood glucose, Blood pressure, Cholesterol, High-density lipoprotein, and triglycerides, at baseline (time1), 6 (time2) and 9 months (time 3).ResultsA total of 56 participants, equal number in intervention and control groups, completed all measurements. A significant difference between the intervention and control groups, in coronary heart disease risk was not found at 6 nor 9-months. However, within-group data demonstrated that 55.4% of the participants had lower coronary heart disease risk in the next ten years at the 9-month measurement. Indicating an overall 18% relative risk reduction of coronary heart disease risk by participating in the trial, with the number needed to treat for one to lower their risk to be nine. Within the intervention group a significant difference was found between time 1 and 3 in lower body mass index (p = 0.046), hemoglobin A1c level (p = 0.018) and diastolic blood pressure (p = 0.03).ConclusionsAlthough unable to show significant group differences in change of coronary heart disease risk by this 12-weeks intervention, the process of regular measurements and the guided self-determination counselling seem to be beneficial for within-group measures and the overall reduction of coronary heart disease risk factors.Trial registrationThis study is a part of the registered study ‘Effectiveness of Nurse-coordinated Follow-Up Programme in Primary Care for People at Risk of T2DM’ at www.ClinicalTrials.gov (NCT04688359) (accessed on 30 December 2020).

NNT and NNH: statistics and stochastics in the evaluation of added therapeutic value

Any pharmacological, invasive, surgical health intervention should have an added therapeutic value as well as the requirements of quality, safety, efficacy, to be considered as a medical device based on scientific evidence and of clinical utility for the patient. The intervention should be shared between the doctor and the patient who should have rigorous but simple tools to decide on the best therapy to undertake. Assessment of relative risk reduction is commonly used in the scientific literature to quantify both statistical and clinical significance. The reduction of the relative risk is independent of the baseline risk and is useful for comparing the results of trials conducted on populations at different risk levels. A biased reading of relative risk reduction can be used to emphasize the magnitude of the benefit for market innovation. The absolute risk reduction, on the other hand, is proportional to the magnitude of the baseline risk and is a more useful parameter for physicians and patients to understand the extent of benefit and harm, especially if the parameter is expressed in terms of the number needed to treat (NNT) or to harm (NNH). The mode of scientific communication is important for doctors' choices and patients' trust. Even true data can be fake in communication and perception by resorting to verbose paraphrases. Presenting the results of clinical trials in stochastic as well as statistical terms is useful for doctors and patients to verify whether it is worth practicing a certain treatment whose success sometimes has the probability of winning the lottery, also considering side effects and adverse events. One of the most important challenges in precision medicine will be understanding the relationship between probability and randomness.

Comparison of Time to Next Treatment or Death Between Front-Line Daratumumab, Lenalidomide, and Dexamethasone (DRd) Versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) Among Transplant-Ineligible Patients With Multiple Myeloma.

Daratumumab, lenalidomide, and dexamethasone (DRd) and bortezomib, lenalidomide, and dexamethasone (VRd) are the only preferred treatment regimens for patients with transplant-ineligible (TIE) newly diagnosed multiple myeloma (NDMM). As there are no randomized head-to-head studies of DRd versus VRd, this analysis aimed to compare real-world time-to-next-treatment (TTNT) or death in this population. Patients with NDMM who received front-line (FL) DRd or VRd were identified from the Acentrus database (January 1, 2018 to May 31, 2023). Those with a record of a stem cell transplant or aged < 65 years were excluded to limit analysis to the TIE population. Inverse probability of treatment weighting was used to balance baseline patient characteristics. A doubly robust Cox proportional hazards model was used to compare TTNT or death between cohorts. A total of 149 and 494 patients who initiated DRd and VRd, respectively, were identified. After weighting (weighted NDRd = 302, weighted NVRd = 341), cohorts had similar baseline characteristics. Of these, 98 (32.4%) DRd and 175 (51.2%) VRd patients either received a subsequent line of therapy or died, with a median TTNT or death of 37.8 months in the DRd cohort and 18.7 months in the VRd cohort (hazard ratio: 0.58, 95% confidence interval: 0.35, 0.81; p < 0.001). Treatment of TIE NDMM patients with DRd led to a significantly longer TTNT or death compared to VRd, evidenced by a 42% risk reduction, supporting the effectiveness of DRd over VRd as FL treatment in this patient population.

How to Promote Data Sharing of Financial Service Providers Based on Federated Learning Technology

Data sharing between financial service providers (FSPs) can promote the reduction of financial risks, but the reality is that the FSPs may be unwilling to share data with each other due to data security problems. The emergence of federated data technology provides a convenient way to address this issue. In this article, the author proposes using a federated data sharing model for FSPs and two dynamic evolutionary games for evaluating influencing factors. Cooperation results when both FSPs reach a certain level of mutual payoff. The reward and punishment mechanisms are important means by which FSPs actively implement real data sharing. The interaction between the FSP and the federated technology service provider (FTSP) demonstrates the practicality of this new technology. The results show that the data sharing improved the data trust and supported regulatory mechanisms.

Agricultural innovation for climate change: limited but positive impacts of commercialized drought-tolerant corn

Abstract The extent to which new technologies can countervail the risks posed by climate change is a critical element for designing adaptation strategies. This study uses new experimental data spanning 17 US states from 2008 to 2023 to examine the potential impact of recently commercialized drought tolerant (DT) traits on both yield and yield resilience in US corn production. We find that there is no yield advantage for DT hybrids under average weather conditions, but they improve yield resilience, particularly with respect to precipitation. These effects are spatially heterogeneous, such that DT has a positive yield impact in the droughty, western US, but a small, or even negative, impact in the central and eastern US. In addition, the presence of DT reduces yield variance and kurtosis, and increases skewness, all of which imply a reduction in yield risk. Using the statistical model estimates, we project the impact of DT on corn yields under future climate conditions obtained from 20 general circulation models with two representative concentration pathways. The projected ensemble means of yield gains are 6.34 bu/acre and 5.39 bu/acre under moderate and extreme warming scenarios, respectively, by the mid-twenty-first century. These gains compensate for 23% and 13.5% of total yield loss due to climate change. Our results indicate that current commercial DT hybrids reduce yield risk, improve resilience with respect to precipitation, and have the potential to offer moderate benefits under climate change warming scenarios.

Degree of joint risk factor control and incident chronic kidney disease among individuals with obesity.

To investigate the extent to which joint risk factor control might attenuate the excess risk of chronic kidney disease (CKD) in participants with obesity. We included a total of 97 538 participants who were obese at baseline and matched 97 538 normal weight control participants from the UK Biobank in the analysis. The degree of joint risk factor control was assessed based on six major CKD risk factors, including blood pressure, glycated haemoglobin, low-density lipoprotein cholesterol, albuminuria, smoking and physical activity. The Cox proportional hazards models were used to estimate associations between the degree of risk factor control and risk of CKD, following participants from their baseline assessment until the occurrence of CKD, death, or the end of the follow-up period. Among participants with obesity, joint risk factor control showed an association with a stepwise reduction of incident CKD risk. Each additional risk factor control corresponded to an 11% (hazard ratio: 0.89; 95% confidence interval: 0.86-0.91) reduced risk of CKD among participants with obesity, with the optimal controlling of all six risk factors associated with a 49% (hazard ratio: 0.51; 95% confidence interval: 0.43-0.61) decrease in risk of CKD. Furthermore, in individuals with obesity who jointly controlled all six risk factors, the excess risk of CKD associated with obesity was effectively neutralized compared with normal weight control subjects. Notably, the protective correlations between the degree of joint risk factor control and the incidence of CKD were more pronounced in men compared with women, in individuals with a lower healthy food score versus a higher score, and among diabetes medication users as opposed to non-users (pinteraction = 0.017, 0.033 and 0.014, respectively). The joint risk factor control is associated with an inverse association of CKD risk in an accumulative manner among individuals with obesity. Achieving ideal control over risk factors may effectively counterbalance the excessive risk of CKD typically associated with obesity.

Smoking Cessation and Incident Cardiovascular Disease

The association between smoking cessation and cardiovascular disease (CVD) risk in relation to cumulative smoking exposure remains poorly understood. To evaluate the associations among smoking cessation, lifetime smoking burden, and CVD risk according to the number of years elapsed after smoking cessation. This retrospective cohort study of the Korean National Health Insurance Service database investigated smoking duration and intensity between January 2006 and December 2008. Participants were categorized by self-reported smoking habits as current, ex-, or never-smokers. Smoking records were updated every 2 years until December 2019, with participants whose smoking status changed or whose smoking status was unclear excluded. Data analysis was performed between June and December 2022. Time-updated self-reported smoking status, years since quitting, and cumulative smoking amount (pack-years [PY]). The primary outcome was incidence and hazard ratio of CVD (composite of cardiovascular death, myocardial infarction, stroke, and heart failure). Overall, 5 391 231 participants (39.9% male; mean [SD] age, 45.8 [14.7] years; 853 756 [15.8%] current smokers, 104 604 [1.9%] ex-smokers, and 4 432 871 [82.2%] never smokers) were followed up for a mean (SD) of 4.2 (4.4) years. The median (IQR) baseline cumulative smoking amounts were 14.0 (7.5-20.0) PY in current smokers and 10.5 (5.3-20.0) PY in ex-smokers. The median (IQR) duration of smoking cessation was 4 (2-8) years for ex-smokers. Regardless of continued smoking, a dose-dependent association was evident between smoking and incident CVD. Compared with current smokers, ex-smokers with a lifetime smoking burden of less than 8 PY (light ex-smokers) experienced a significant reduction in CVD risk within 10 years of cessation, with a CVD risk similar to that of never-smokers. Conversely, ex-smokers with at least 8 PY (heavy ex-smokers) exhibited a slower decline in CVD risk than light ex-smokers, requiring more than 25 years for the residual CVD risk to disappear. In this cohort study, smoking and CVD risk exhibited a dose-dependent association, with light ex-smokers having a CVD risk similar to that of never-smokers relatively soon after smoking cessation. For heavy ex-smokers, greater than 25 years might be required for the residual CVD risk to align with that of never-smokers.

Assessment of socio-economic strategies for managing regional flood risk in an urban coastal catchment

With the cascading flooding events over the past decades, several structural and non-structural measures have been effectively implemented for improved flood management. However, the uneven impacts of the flooding events have highlighted that socio-economic inequality amongst the community needs to be addressed along with hazards to devise long term and sustainable flood management strategies. This study aims to evaluate the impact of socio-economic adaptive scenarios over an urban coastal catchment for reduction in flood risk. Flood risk is estimated utilizing socio-economic aspects (vulnerability) and flood inundation (hazard), for the highly flood-prone coastal city of Mumbai, India. A multivariate approach is used for assessing socio-economic vulnerability, starting with Principal Component Analysis followed by Data Envelopment Analysis, for various socio-economic scenarios, i.e., by reducing percentage of certain feasible socio-economic sensitivity indicators, to identify the key indicators, which contribute to significant change in vulnerability. The flood hazard is assessed through a comprehensive hydrodynamic flood modelling approach to quantify the flood inundation depth and extent. The flood risk is, thereafter, evaluated by combining socio-economic vulnerability and flood hazard using bivariate risk mapping approach. The results indicate that, with the decrease in alteration percentage of certain feasible socio-economic sensitivity indicators, the overall vulnerability and flood risk may be reduced. The areas under very high and high vulnerability classes reduce gradually for all scenarios as the percentage reduction for various indicators is varied from 5 % to 15 %, total illiteracy being the most significant indicator. This study marks the first effort to discern socio-economic vulnerability indicators that have the potential to significantly diminish flood risk, thereby constituting a viable long-term flood risk mitigation strategy. This novel framework is generic and applicable to any flood prone catchments, to devise appropriate long-term flood management measures.

Physician variation in adopting prophylactic salpingectomy at the time of postpartum sterilization for ovarian cancer risk reduction

Physician variation in adopting prophylactic salpingectomy at the time of postpartum sterilization for ovarian cancer risk reduction

Screening for Breast Cancer Risk: An Analysis of Under-recognized Risk Factors and Comparison of Interventions.

Recognition of patients at high risk (HR) for breast cancer allows earlier screening and opportunities for risk reduction. We compare patients referred to our breast clinic as HR vs referrals for other reason (ROR) and found to be HR. We evaluate under-recognized factors and treatment differences. A retrospective chart review of patients found to be HR but referred for any reason to our breast clinic from July 2012 to December 2022 was performed. Referral reason, demographics, hormonal history, family history, and other risk factors were evaluated and compared (HR vs ROR). While other risk models were used for screening, Gail and Tyrer-Cuzick version 7 (TCv7) were used for comparison. Breast imaging received, hormonal therapy, and genetics referral evaluations were compared. 195 patients were referred to our breast team, 113 (58%) were referred as HR while 82 (42%) were ROR. Average age was 47 years old. 175 (91%) were Caucasian. 74 (65.5%) were referred for genetic testing, and 32 (26%) tested positive for a genetic mutation (n = 10, 12% ROR). 67 (35%) were recommended chemoprevention (n = 32, 16.4% took chemoprevention). 6 (3.1%) underwent prophylactic mastectomies and 163 (85%) had supplemental breast imaging. Comparison of HR vs ROR did not show significant differences in hormonal factors or treatments received; however, TCv7 was higher in the group referred as HR (P < .001). Our study showed that HR patients are more commonly referred secondary to family history but undergo similar treatments as those ROR. Accessibility to screening tools and education of risk factors, especially in minorities and those not otherwise being screened, may help better recognize HR.

NOVEL AGENTS IN THE MANAGEMENT OF DIABETES AND RISK OF WORSENING DIABETIC RETINOPATHY.

Novel therapies for diabetes have potent effects on glycemic control, obesity, and cardiovascular risk reduction, but some, including the popular drug semaglutide, have also been implicated in worsening of diabetic retinopathy (DR). Given the ubiquity of these new agents, understanding the risks to vision is important. Here, we review the data for several newly available agents in terms of systemic efficacy and retinal safety. Literature review. Novel antihyperglycemic treatments include incretin mimetics and enhancers, sodium-glucose cotransporter inhibitors, long-acting insulins, and insulin delivery systems. All improve glycemic control, and some have been shown to reduce major cardiovascular outcomes. In a pivotal trial, semaglutide was associated with approximately 75% increased risk of DR worsening. The novel long-acting insulin icodec, formulated for once weekly dosing, showed increased risk of DR worsening over a once daily insulin. No other recent antihyperglycemic agent was associated with DR worsening, although following the semaglutide trials, nearly all studies excluded patients with preexisting DR. Cases of DR worsening were rare in all instances. Dedicated safety studies for semaglutide in DR are currently underway. For most patients being considered for treatment with a novel antihyperglycemic agent, benefits on systemic metabolic and cardiovascular health are very likely to outweigh potential retinal harms. Although the true risks of the new agents on DR are unclear because their safety data come from secondary end points, the most vulnerable patients are those with preexisting high-risk DR, poor baseline glycemic control, and using insulin.

Examining The VTP Protocol, Identifying the Risks of Its Use and Providing Risk Reduction Solutions in The Computer Networks of Offices and Large Organizations

Today, one of the challenges of computer networks implemented in large offices and organizations is maintaining the stability and security of networks, as well as the ease and automation of their configuration to save the time and energy of network administrators. The VTP protocol is a tool to ease and reduce the burden of manually configuring changes to VLANs on Cisco switches. However, the use of this protocol, despite having advantages such as automatic configuration and centralized management of VLANs, has great risks such as the complexity of implementation in large networks and the loss of settings in case of wrong configuration. The problem studied in this article is to investigate the characteristics and function of this protocol and to recognize the possible risks and dangers associated with its use. In the following, solutions are provided to reduce these risks so that the benefits of this protocol can be used and at the same time protect the stability and security of the network implemented in the organization. By using this evaluation, network administrators can have an optimal and more informed use of this protocol.

Association of long-term exposure to ozone with cardiovascular mortality and its metabolic mediators: evidence from a nationwide, population-based, prospective cohort study

Previous studies about chronic effects of ozone (O3) on cardiovascular mortality are scarce and inconclusive. We aimed to investigate the association between cardiovascular mortality and a broad range of long-term O3 exposure levels. This analysis included 3,206,871 participants aged 35-75 years enrolled in the ChinaHEART study. Participants were recruited from the 31 provinces of the Chinese mainland between January 2015 and December 2020. The five-year average O3 concentrations before baseline visits were calculated to represent long-term exposure. Over a median follow-up period of 4.7 (interquartile range: 3.7-6.2) years, 35,553 (1.1%) participants died from cardiovascular diseases (CVD). Following multivariable adjustment, nonlinear relationships were identified between O3 concentrations and CVD and ischemic heart disease (IHD) mortality, with inflection points at 85.44 and 88.15μg/m3, respectively. Above these points, a 10.0μg/m3 increase in the O3 level was associated with a 13.9% (hazard ratio [HR]: 1.139, 95% confidence interval [CI]: 1.096-1.184) and 25.0% (HR: 1.250, 95% CI: 1.151-1.357) greater risk of CVD and IHD mortality, respectively. Conversely, O3 exposure exhibited a linear relationship with ischemic stroke mortality. Moreover, the metabolic factors explained more than half of the association between O3 exposure and CVD mortality. Substantial influences of long-term O3 exposure on CVD mortality were identified, with notable mediation proportions attributed to metabolic factors. These findings could facilitate the air quality standard revisions and risk reduction strategy making in the future. This study was supported by the CAMS Innovation Fund for Medical Science (2021-1-I2M-011), the CAMS Innovation Fund for Medical Science (CIFMS, 2022-I2M-C&T-A-010), the National High Level Hospital Clinical Research Funding (2022-GSP-GG-4), the Ministry of Finance of China and National Health Commission of China, the 111 Project from the Ministry of Education of China (B16005).

Factors influencing gynecologic risk reduction surgeries for BRCA1 or BRCA2 germline mutation carriers

Factors influencing gynecologic risk reduction surgeries for BRCA1 or BRCA2 germline mutation carriers

Effects of Extracted Pulse Proteins on Lipid Targets for Cardiovascular Risk Reduction: Systematic Review and Meta-Analysis of Randomized Controlled Trials

Effects of Extracted Pulse Proteins on Lipid Targets for Cardiovascular Risk Reduction: Systematic Review and Meta-Analysis of Randomized Controlled Trials

A novel clinical prediction model for hip fractures: a development and validation study in the total population of Sweden

Low bone density and osteoporosis are indications for bone-specific treatment. However, given the limited availability of bone density data in clinical practice and the fact that most patients with hip fracture do not have osteoporosis, accurate prediction of hip fracture risk in the absence of bone density data would be crucial. This development and validation study included the entire Swedish population aged 50 years or older in 2005 (N=3,340,977) and was conducted by cross-linking data from nationwide registers. Potential predictive variables included diagnoses, prescription medications, familial factors, frailty-related factors, and socioeconomic factors. The primary endpoint was the 5-year risk of hip fracture. Fracture prediction algorithms were developed and validated using multivariable models. Model performance and validation was also examined in a sub cohort restricted to 504,431 individuals with non-Swedish background. During a total follow-up of 15.2 million person-years, 87,089 individuals suffered a hip fracture within 5 years. In the final prediction model, 19 variables were associated with a population attributable fraction of 93.9% (95% CI, 93.7-94.1) in women and 92.7% (95% CI, 92.2-93.0) in men. The strongest predictor, besides old age, was the use of homemaker service, with a 5-year risk of hip fracture of 7.8% in women and 4.7% in men. The diagnoses most strongly predicting the 5-year risk of hip fracture was Parkinson's disease (6.8% in women, 4.6% in men) and dementia (6.1% in women, 3.6% in men). Validation of the prediction model suggested that the optimal threshold for treatment with bone-specific agents was an estimated 5-year hip fracture risk of 3%. Assuming a threshold of 3% and a 30% relative risk reduction from bone-specific treatment, the number needed to treat to prevent one hip fracture was estimated to 36 in women and 52 in men. Similar results were obtained in the sub cohort with non-Swedish background. A clinical prediction model developed and validated in the total Swedish population could predict the risk of hip fractures with high precision even in absence of data on bone density. The model was associated with a population attributable fraction for hip fracture of more than 90%, and the strongest predictor besides old age was the use of homemaker service, which likely reflect frailty. Based on the model, individuals with an estimated 5-year risk of hip fracture of at least 3% could be considered for bone-specific treatment. None.

Effect of increased systemic oxygen delivery on postoperative outcomes and quality of life in elderly undergoing major abdominal surgery: A randomised controlled trial.

Studies comparing the intentional increase in oxygen delivery and normal oxygen delivery during general anaesthesia in elderly patients undergoing major abdominal surgery are limited and have reported contradictory findings. Therefore, the study aimed to evaluate the effect of intraoperative increase in systemic oxygen delivery on postoperative outcomes and quality of life in elderly patients undergoing major abdominal surgery. This randomised, blinded, parallel-arm, pragmatic clinical trial included elderly patients of >60 years of age undergoing major abdominal surgery. The patients in the intervention arm received noradrenaline or increased fractional inspiration of oxygen to augment central venous oxygen saturation ⩾75%. The primary outcome measure was composite of in-hospital mortality and major organ complications. The secondary outcome measure included comparison of quality of life. A total of 160 patients were assessed for eligibility, and 146 were randomised in the study groups. The mean arterial and central venous oxygen saturation increased and were significantly higher in the intervention arm. The composite primary outcome occurred in 49.31% in the intervention arm and 57.53% in the usual care arm (relative risk; 95% confidence interval: 0.85; 0.63-1.16; absolute risk reduction; 8.22%; p = 0.32). Furthermore, quality of life at the end of three months was similar (0.658 ± 0.19 versus 0.647 ± 0.19; p = 0.771). In conclusion, central venous oxygen saturation-guided increase in systemic oxygen delivery during the intraoperative period of major abdominal surgery in elderly patients did not reduce predefined composite outcome of in-hospital mortality or organ-specific complications.

Implants versus autologous tissue flaps for breast reconstruction following mastectomy.

Women who have a mastectomy for breast cancer treatment or risk reduction may be offered different options for breast reconstruction, including use of implants or the woman's own tissue (autologous tissue flaps). The choice of technique depends on factors such as the woman's preferences, breast characteristics, preoperative imaging, comorbidities, smoking habits, prior chest or breast irradiation, and planned adjuvant therapies. To assess the effects of implants versus autologous tissue flaps for postmastectomy breast reconstruction on women's quality of life, satisfaction, and short- and long-term surgical complications. We searched the Cochrane Breast Cancer Group's Specialised Register, CENTRAL, MEDLINE, Embase, and two trials registries in July 2022. We included studies that compared implant-based reconstruction with autologous tissue-based reconstruction following mastectomy for breast cancer treatment or risk reduction. The minimum eligible sample size was 100 participants. Two review authors independently assessed risk of bias and extracted data using standard Cochrane procedures. We used GRADE to assess the certainty of the evidence. Thirty-five non-randomised studies with 57,555 participants met our inclusion criteria. There were nine prospective cohort studies and 26 retrospective cohort studies. We judged 26 studies at serious overall risk of bias and the remaining studies at moderate overall risk of bias. Some studies measured quality of life and satisfaction using the BREAST-Q (scale of 0 to 100, higher is better). Implants may reduce postoperative psychosocial well-being compared with autologous tissue flaps (mean difference (MD) -4.26 points, 95% confidence interval (CI) -4.91 to -3.61; I² = 0%; 6 studies, 3335 participants; low-certainty evidence). Implants may reduce or have little to no effect on postoperative physical well-being compared with autologous tissue flaps, but the evidence is very uncertain (MD -1.92 points, 95% CI -4.44 to 0.60; I² = 87%; 6 studies, 3335 participants; very low-certainty evidence). Implants may reduce postoperative sexual well-being compared with autologous reconstruction (MD -6.63 points, 95% CI -7.55 to -5.72; I² = 0; 6 studies, 3335 participants; low-certainty evidence). Women who undergo breast reconstruction with implants versus autologous tissue flaps may be less satisfied with the breast, but the evidence is very uncertain (MD -8.17 points, 95% CI -11.41 to -4.92; I² = 90%; 6 studies, 3335 participants; very low-certainty evidence). This outcome refers to a woman's satisfaction with breast size, bra fit, appearance in the mirror (clothed or unclothed), and how the breast feels to touch. Women who undergo breast reconstruction with implants versus autologous tissue flaps may be less satisfied with the reconstruction (MD -5.96 points, 95% CI -10.24 to -1.68; I² = 62%; 4 studies, 1196 participants; low-certainty evidence). This outcome refers to whether the aesthetic outcome has met the woman's expectations, the impact surgery has had on her life, and whether she thinks she made the right decision to have the reconstruction. Implants may reduce or have little to no effect on the risk of short-term complications compared with autologous tissue flaps, but the evidence is very uncertain (risk ratio (RR) 0.80, 95% CI 0.63 to 1.03; I² = 91%; 22 studies, 34,244 participants; very low-certainty evidence). Implants may increase long-term complications compared with autologous tissue flaps, but the evidence is very uncertain (RR 1.56, 95% CI 1.09 to 2.22; I² = 94%; 17 studies, 26,930 participants; very low-certainty evidence). Implants may have little to no effect on the need for reintervention compared with autologous tissue flaps, but the evidence is very uncertain (RR 1.23, 95% CI 0.91 to 1.68; I² = 93%; 15 studies, 14,171 participants; very low-certainty evidence). Implants may reduce the duration of surgery compared with autologous tissue flaps, but the evidence is very uncertain (MD -125.04 minutes, 95% CI -131.41 to -118.67; I² = 0; 2 studies, 836 participants; very low-certainty evidence). The findings of this review show that autologous tissue-based reconstruction compared with implant-based reconstruction may improve participant-reported outcomes such as psychosocial well-being, sexual well-being, and satisfaction with the reconstruction. There is also very uncertain evidence to suggest that autologous tissue-based reconstruction increases satisfaction with the breast and reduces the risk of long-term complications compared with implants. Implant-based reconstruction may be a shorter procedure, but the evidence is very uncertain. Despite the growing demand for breast reconstruction, the best technique has not been adequately studied in randomised controlled trials (RCTs), and the evidence provided by non-randomised studies is often unsatisfactory. There is no superior breast reconstruction technique for all women. Future research should focus on the definition of decisional drivers to guide an evidence-based shared decision-making process in reconstructive breast surgery.

Long-Term Benefits and Safety of Statins in Patients with Kidney Failure: A Target Trial Emulation Study.

Patients with kidney failure are at elevated risk of cardiovascular diseases. Although statins were commonly used to mitigate cardiovascular disease risk among the population with high risk, the evidence for initiating statin therapy among patients with kidney failure remains inconclusive. This study aimed to investigate the long-term benefits and risks associated with statin therapy in patients with kidney failure. Using territory-wide public electronic health records in Hong Kong, 3,019 statin-eligible individuals with kidney failure and elevated LDL cholesterol ≥ 100 mg/dL from Jan 2008 to Dec 2015 were included for analysis. The framework of target trial emulation was adopted to investigate the risk of the major cardiovascular diseases (i.e., a composite of myocardial infarction, heart failure and stroke), all-cause mortality, as well as the major adverse events (i.e., myopathies and liver dysfunction) between statin initiators and statin non-initiators. The pooled logistic model was used to obtain the hazard ratio (HRs) for the outcomes of interest in both intention-to-treat (ITT) analysis and per-protocol (PP) analysis. Significant risk reduction associated with statin therapy (HR [95%CI]) was observed for major cardiovascular diseases (ITT: 0.78 [0.62, 0.98]; PP: 0.66 [0.50, 0.87]) and all-cause mortality (ITT: 0.80 [0.68, 0.95]; PP: 0.60 [0.48, 0.76]). The standardised 5-year and 10-year absolute risk reduction in per-protocol analysis was 7% (3%, 11%) and 11% (4%, 18%), respectively. No significant risks for the major adverse events were observed. Statin therapy was associated with lower risks of cardiovascular diseases and all-cause mortality in patients with kidney failure without a higher risk of major adverse events.

Cardiovascular effects of obstructive sleep apnoea and effects of continuous positive airway pressure therapy: evidence from different study models

INTRODUCTIONCardiovascular consequences of obstructive sleep apnoea (OSA) and the effects of continuous positive airway pressure (CPAP) therapy on blood pressure, endothelial dysfunction, and MACE (major adverse cardiovascular events) have been studied over decades using different study designs. However, clinical findings from different study models on cardiovascular outcomes are sometimes contradictory.METHODSA literature search was conducted in PubMed for randomised controlled trials, meta-analyses, population-based epidemiological studies and OSA cohort studies up to September 2023 investigating the cardiovascular effect of OSA and CPAP in adults with OSA on the following cardiovascular endpoints: blood pressure, arterial hypertension, endothelial function, and MACE (myocardial infarction, stroke, transient ischemic attack, cardiovascular death). The level of evidence for these outcomes was discussed on the basis of different study models.RESULTS AND CONCLUSIONSThere is high-level evidence of a causal relationship between OSA and arterial hypertension and endothelial dysfunction, as well as on higher MACE incidence among subgroups of patients with untreated OSA. The cardiovascular effects of OSA depend on the severity of OSA, symptoms, phenotype, and comorbidities. The blood pressure-lowering effect of CPAP is mainly observed in uncontrolled and treatment-resistant hypertension. The MACE risk reduction in OSA depends on good long-term CPAP adherence. Younger, sleepy patients with more severe OSA, higher hypoxaemic burden and without overt cardiovascular end-organ disease may particularly benefit from CPAP treatment in terms of cardiovascular risk reduction. Randomised controlled trials of CPAP or other effective OSA treatments in primary cardiovascular prevention and in patients at highest risk are lacking.