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Background: Silicone gel breast implants were removed from the U.S. market for cosmetic use in 1992 owing to safety concerns. They were reintroduced in 2006, with a call for improved surveillance of clinical outcomes.Purpose: To systematically review the literature regarding specific long-term health outcomes in women with silicone gel breast implants, including cancer; connective tissue, rheumatologic, and autoimmune diseases; neurologic diseases; reproductive issues, including lactation; offspring issues; and mental health issues (depression and suicide).Data Sources: MEDLINE, EMBASE, and Ovid Healthstar (inception through 30 June 2015), and the Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews (through the first quarter of 2015).Study Selection: 4 researchers double-screened articles for longitudinal studies that compared women with and without breast implants and reported long-term health outcomes of interest.Data Extraction: 4 researchers extracted data on participant and implant characteristics, analytic methods, and results.Data Synthesis: 32 studies (in 58 publications) met eligibility criteria. Random-effects model meta-analyses of effect sizes were conducted when feasible. For most outcomes, there was at most only a single adequately adjusted study, which usually found no significant associations. There were possible associations with decreased risk for primary breast and endometrial cancers and increased risks for lung cancer, rheumatoid arthritis, Sjögren syndrome, and Raynaud syndrome. Evidence on breast implants and other outcomes either was limited or did not exist.Limitation: The evidence was most frequently not specific to silicone gel implants, and studies were rarely adequately adjusted for potential confounders.Conclusion: The evidence remains inconclusive about any association between silicone gel implants and long-term health outcomes. Better evidence is needed from existing large studies, which can be reanalyzed to clarify the strength of associations between silicone gel implants and health outcomes.Primary Funding Source: The Plastic Surgery Foundation. [ABSTRACT FROM AUTHOR]

Background: Trials have shown efficacy of rigorous diet and physical activity promotion programs to reduce diabetes incidence and improve glycemic measures in adults at increased risk for type 2 diabetes.Purpose: To evaluate diet and physical activity promotion programs for persons at increased risk for type 2 diabetes, primarily to reduce diabetes risk and decrease body weight and glycemia.Data Sources: MEDLINE, the Cochrane Central Register of Controlled Trials, CAB Abstracts, Global Health, and Ovid HealthSTAR from 1991 through 27 February 2015, with no language restriction.Study Selection: 8 researchers screened articles for single-group or comparative studies of combined diet and physical activity promotion programs with at least 2 sessions over at least 3 months in participants at increased risk for type 2 diabetes.Data Extraction: 7 researchers extracted data on study design; participant, intervention, and outcome descriptions; and results and assessed study quality.Data Synthesis: 53 studies (30 of diet and physical activity promotion programs vs. usual care, 13 of more intensive vs. less intensive programs, and 13 of single programs) evaluated 66 programs. Compared with usual care, diet and physical activity promotion programs reduced type 2 diabetes incidence (risk ratio [RR], 0.59 [95% CI, 0.52 to 0.66]) (16 studies), decreased body weight (net change, -2.2% [CI, -2.9% to -1.4%]) (24 studies) and fasting blood glucose level (net change, -0.12 mmol/L [-2.2 mg/dL] [CI, -0.20 to -0.05 mmol/L {-3.6 to -0.9 mg/dL}]) (17 studies), and improved other cardiometabolic risk factors. Evidence for clinical events was limited. More intensive programs were more effective.Limitations: Wide variation in diet and physical activity promotion programs limited identification of features most relevant to effectiveness. Evidence on clinical outcomes and in children was sparse.Conclusion: Combined diet and physical activity promotion programs are effective at decreasing diabetes incidence and improving cardiometabolic risk factors in persons at increased risk. More intensive programs are more effective.Primary Funding Source: Centers for Disease Control and Prevention Community Preventive Services Task Force. [ABSTRACT FROM AUTHOR]

BACKGROUND: Previous systematic reviews of implantable cardioverter defibrillators (ICDs) used for primary prevention of sudden cardiac death (SCD) concluded that ICDs are less effective in women and the elderly. PURPOSE: To examine ICD effectiveness for primary prevention of SCD across subgroups by sex, age, New York Heart Association class, left ventricular ejection fraction, heart failure, left bundle branch block, QRS interval, time since myocardial infarction, blood urea nitrogen level, and diabetes. DATA SOURCES: MEDLINE and the Cochrane Central Register of Controlled Trials through 3 September 2013 with no language restriction. STUDY SELECTION: Researchers screened articles for studies comparing ICD versus no ICD for primary prevention. Data Extraction: Data were extracted about study design, patients, interventions, mortality and SCD outcomes, subgroup characteristics, and subgroup effects. Quality of subgroup analyses was determined by consensus. Relative odds ratios comparing subgroup effects were calculated, and random-effects model meta-analyses were conducted on these ratios. DATA SYNTHESIS: Meta-analysis of 14 studies showed a decrease in deaths and SCDs due to ICD treatment. Ten studies provided subgroup analyses. Nine studies compared ICD versus no ICD, whereas one compared cardiac resynchronization therapy plus a defibrillator versus no ICD. Within-study interaction tests and across-study meta-analyses yielded weak evidence that did not show differences for all-cause mortality in subgroups by sex, age, and QRS interval. The evidence was indeterminate for other evaluated subgroups because of a paucity of data. LIMITATION: Many subgroup analyses were underpowered, which may have resulted in false-negative findings. CONCLUSION: Weak evidence fails to show differences for all-cause mortality in subgroups of sex, age, and QRS interval. Evidence is indeterminate for all-cause mortality in the other subgroups and for SCD. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality. [ABSTRACT FROM AUTHOR]

Background: Previous systematic reviews of implantable cardioverter defibrillators (ICDs) used for primary prevention of sudden cardiac death (SCD) concluded that ICDs are less effective in women and the elderly. Purpose: To examine ICD effectiveness for primary prevention of SCD across subgroups by sex, age, New York Heart Association class, left ventricular ejection fraction, heart failure, left bundle branch block, QRS interval, time since myocardial infarction, blood urea nitrogen level, and diabetes. Data Sources: MEDLINE and the Cochrane Central Register of Controlled Trials through 3 September 2013 with no language restriction. Study Selection: Researchers screened articles for studies comparing ICD versus no ICD for primary prevention. Data Extraction: Data were extracted about study design, patients, interventions, mortality and SCD outcomes, subgroup characteristics, and subgroup effects. Quality of subgroup analyses was determined by consensus. Relative odds ratios comparing subgroup effects were calculated, and random-effects model meta-analyses were conducted on these ratios. Data Synthesis: Meta-analysis of 14 studies showed a decrease in deaths and SCDs due to ICD treatment. Ten studies provided subgroup analyses. Nine studies compared ICD versus no ICD, whereas one compared cardiac resynchronization therapy plus a defibrillator versus no ICD. Within-study interaction tests and across-study meta-analyses yielded weak evidence that did not show differences for all-cause mortality in subgroups by sex, age, and QRS interval. The evidence was indeterminate for other evaluated subgroups because of a paucity of data. Limitation: Many subgroup analyses were underpowered, which may have resulted in false-negative findings. Conclusion: Weak evidence fails to show differences for all-cause mortality in subgroups of sex, age, and QRS interval. Evidence is indeterminate for all-cause mortality in the other subgroups and for SCD. Primary Funding Source: Agency for Healthcare Research and Quality. [ABSTRACT FROM AUTHOR]

Background: Lipid-lowering therapy is not widely used in persons with chronic kidney disease (CKD) despite a high burden of dys-lipidemia and cardiovascular disease in this population. Purpose: To synthesize evidence examining the effect of lipid-lowering therapy on clinical outcomes in persons with CKD. Data Sources: MEDLINE, the Cochrane Central Register of Con-trolled Trials, and the Cochrane Database of Systematic Reviews from January 2000 through November 2011. Study Selection: Randomized, controlled trials (RCTs) comparing lipid-lowering therapy with control treatment in persons with CKD, including subgroup analyses of trials in the general population. Data Extraction: Abstracts were screened and data were extracted on study methodology, population, interventions, cardiovascular and kidney outcomes, and adverse events. Data were extracted by one author and confirmed by another. Study quality was deter-mined by consensus. Random-effects model meta-analyses were performed. Data Synthesis: 18 RCTs, all in adults, met the eligibility criteria. Five RCTs involved CKD populations, and 13 were CKD subgroup analyses from trials in the general population. Sixteen RCTs examined statins, and 2 examined statins plus ezetimibe. Lipid-lowering therapy does not improve kidney outcomes but decreases the risk for cardiac mortality (pooled risk ratio [RR] from 6 trials, 0.82 [95% Cl, 0.74 to 0.91]; P< 0.001), cardiovascular events (including revascularization) (pooled RR from 9 trials, 0.78 [Cl, 0.71 to 0.86]; P< 0.001), and myocardial infarction (pooled RR from 9 trials, 0.74 [Cl, 0.67 to 0.81]; P< 0.001). Significant benefit was also seen for all-cause mortality but was limited by a high degree of heterogeneity. No benefit was found for other cardiovascular out-comes. Rates of adverse events were similar between intervention and comparator groups. Limitations: Lack of data in children, heterogeneity among re-viewed studies, and the possibility of selective reporting of out-comes and adverse events. Conclusion: Lipid-lowering therapy decreases cardiac death and atherosclerosis-mediated cardiovascular events in persons with CKD. Primary Funding Source: Kidney Diseases: Improving Global Outcomes. [ABSTRACT FROM AUTHOR]

Background: Clinical laboratories are increasingly reporting estimated glomerular filtration rate (GFR) by using serum creatinine assays traceable to a standard reference material. Purpose: To review the performance of GFR estimating equations to inform the selection of a single equation by laboratories and the interpretation of estimated GFR by clinicians. Data Sources: A systematic search of MEDLINE, without language restriction, between 1999 and 21 October 2011. Study Selection: Cross-sectional studies in adults that compared the performance of 2 or more creatinine-based GFR estimating equations with a reference GFR measurement. Eligible equations were derived or reexpressed and validated by using creatinine measurements traceable to the standard reference material. Data Extraction: Reviewers extracted data on study population characteristics, measured GFR, creatinine assay, and equation performance. Data Synthesis: Eligible studies compared the MDRD (Modification of Diet in Renal Disease) Study and CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equations or modifications thereof. In 12 studies in North America, Europe, and Australia, the CKD-EPI equation performed better at higher GFRs (approximately >60 mL/min per 1.73 m2) and the MDRD Study equation performed better at lower GFRs. In 5 of 8 studies in Asia and Africa, the equations were modified to improve their performance by adding a coefficient derived in the local population or removing a coefficient. Limitation: Methods of GFR measurement and study populations were heterogeneous. Conclusion: Neither the CKD-EPI nor the MDRD Study equation is optimal for all populations and GFR ranges. Using a single equation for reporting requires a tradeoff to optimize performance at either higher or lower GFR ranges. A general practice and public health perspective favors the CKD-EPI equation. Primary Funding Source: Kidney Disease: Improving Global Outcomes. [ABSTRACT FROM AUTHOR]

Background: The optimal blood pressure target in patients with chronic kidney disease (CKD) is unclear. Purpose: To summarize trials comparing lower versus higher blood pressure targets in adult patients with CKD and focus on proteinuria as an effect modifier. Data Sources: MEDLINE and the Cochrane Central Register of Controlled Trials (July 2001 through January 2011) were searched for reports from randomized, controlled trials with no language restriction. Study Selection: Authors screened abstracts to identify reports from trials comparing blood pressure targets in adults with CKD that had more than 50 participants per group; at least 1-year follow-up; and outcomes of death, kidney failure, cardiovascular events, change in kidney function, number of antihypertensive agents, and adverse events. Data Extraction: Reviewers extracted data on study design, methods, sample characteristics, interventions, comparators, outcomes, number of medications, and adverse events and rated study quality and quality of analyses for proteinuria subgroups. Data Synthesis: Three trials with a total of 2272 participants were included. Overall, trials did not show that a blood pressure target of less than 125/75 to 130/80 mm Hg is more beneficial than a target of less than 140/90 mm Hg. Lower-quality evidence suggests that a low target may be beneficial in subgroups with proteinuria greater than 300 to 1000 mg/d. Participants in the low target groups needed more antihypertensive medications and had a slightly higher rate of adverse events. Limitations: No study included patients with diabetes. Trial duration may have been too short to detect differences in clinically important outcomes, such as death and kidney failure. Ascertainment and reporting of adverse events was not uniform. Conclusion: Available evidence is inconclusive but does not prove that a blood pressure target of less than 130/80 mm Hg improves clinical outcomes more than a target of less than 140/90 mm Hg in adults with CKD. Whether a lower target benefits patients with proteinuria greater than 300 to 1000 mg/d requires further study. [ABSTRACT FROM AUTHOR]

This paper summarizes major changes in treatment of hepatitis C in chronic kidney disease (CKD) as recommended by the Kidney Disease: Improving Global Outcomes (KDIGO) 2022 clinical practice guideline for the prevention, diagnosis, evaluation, and treatment of hepatitis C. In particular, it highlights new evidence and subsequent recommendations on expanding treatment of hepatitis C in patients with CKD, expanding the donor pool for kidney transplant recipients with kidney donors who are positive for hepatitis C virus, and treating hepatitis C in patients with glomerulonephritis. Description: The Kidney Disease: Improving Global Outcomes (KDIGO) 2022 clinical practice guideline on prevention, diagnosis, evaluation, and treatment of hepatitis C in chronic kidney disease (CKD) is an update of the 2018 guideline from KDIGO. Methods: The KDIGO Work Group (WG) updated the guideline, which included reviewing and grading new evidence that was identified and summarized. As in the previous guideline, the WG used the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach to appraise evidence and rate the strength of recommendations and used expert judgment to develop recommendations. New evidence led to updating of recommendations in the chapters on treatment of hepatitis C virus (HCV) infection in patients with CKD (Chapter 2), management of HCV infection before and after kidney transplant (Chapter 4), and diagnosis and management of kidney disease associated with HCV infection (Chapter 5). Recommendations in chapters on detection and evaluation of hepatitis C in CKD (Chapter 1) and prevention of HCV transmission in hemodialysis units (Chapter 3) were not updated because of an absence of significant new evidence. Recommendations: The 2022 updated guideline includes 43 graded recommendations and 20 ungraded recommendations, 7 of which are new or modified on the basis of the most recent evidence and consensus among the WG members. The updated guidelines recommend expanding treatment of hepatitis C with sofosbuvir-based regimens to patients with CKD glomerular filtration rate categories G4 and G5, including those receiving dialysis; expanding the donor pool for kidney transplant recipients by accepting HCV-positive kidneys regardless of the recipient's HCV status; and initiating direct-acting antiviral treatment of HCV-infected patients with clinical evidence of glomerulonephritis without requiring kidney biopsy. The update also addresses the use of immunosuppressive regimens in such patients. [ABSTRACT FROM AUTHOR]

This article summarizes key updates from the KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease. The summary highlights revised recommendations on what constitutes comprehensive care and on use of sodium–glucose cotransporter-2 inhibitors and glucagon-like peptide-1 receptor agonists and adds a section on use of mineralocorticoid receptor antagonists. Description: The KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease is an update of the 2020 guideline from Kidney Disease: Improving Global Outcomes (KDIGO). Methods: The KDIGO Work Group updated the guideline, which included reviewing and grading new evidence that was identified and summarized. As in the previous guideline, the Work Group used the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach to appraise evidence and rate the strength of recommendations and expert judgment to develop consensus practice points. New evidence led to updating of recommendations in the chapters Comprehensive Care in Patients With Diabetes and CKD (Chapter 1) and Glucose-Lowering Therapies in Patients With T2D and CKD (Chapter 4). New evidence did not change recommendations in the chapters Glycemic Monitoring and Targets in Patients With Diabetes and CKD (Chapter 2), Lifestyle Interventions in Patients With Diabetes and CKD (Chapter 3), and Approaches to Management of Patients With Diabetes and CKD (Chapter 5). Recommendations: The updated guideline includes 13 recommendations and 52 practice points for clinicians caring for patients with diabetes and chronic kidney disease (CKD). A focus on preserving kidney function and maintaining well-being is recommended using a layered approach to care, starting with a foundation of lifestyle interventions, self-management, and first-line pharmacotherapy (such as sodium–glucose cotransporter-2 inhibitors) demonstrated to improve clinical outcomes. To this are added additional drugs with heart and kidney protection, such as glucagon-like peptide-1 receptor agonists and nonsteroidal mineralocorticoid receptor antagonists, and interventions to control risk factors for CKD progression and cardiovascular events, such as blood pressure, glycemia, and lipids. [ABSTRACT FROM AUTHOR]

Description: The Kidney Disease: Improving Global Outcomes (KDIGO) 2021 clinical practice guideline for the management of blood pressure (BP) in patients with chronic kidney disease (CKD) not receiving dialysis is an update of the KDIGO 2012 guideline on the same topic and reflects new evidence on the risks and benefits of BP-lowering therapy among patients with CKD. It is intended to support shared decision making by health care professionals working with patients with CKD worldwide. This article is a synopsis of the full guideline.Methods: The KDIGO leadership commissioned 2 co-chairs to convene an international Work Group of researchers and clinicians. After a Controversies Conference in September 2017, the Work Group defined the scope of the evidence review, which was undertaken by an evidence review team between October 2017 and April 2020. Evidence reviews were done according to the Cochrane Handbook. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach was used to guide the development of the recommendations and rate the strength and quality of the evidence. Practice points were included to provide guidance when evidence was insufficient to make a graded recommendation. The guideline was revised after public consultation between January and March 2020.Recommendations: The updated guideline comprises 11 recommendations and 20 practice points. This synopsis summarizes key recommendations pertinent to the diagnosis and management of high BP in adults with CKD, excluding those receiving kidney replacement therapy. In particular, the synopsis focuses on recommendations for standardized BP measurement and a target systolic BP of less than 120 mm Hg, because these recommendations differ from some other guidelines. [ABSTRACT FROM AUTHOR]

This review assessed global health technology assessment (HTA) reports and recommendations of non-vitamin K oral anticoagulants (NOACs) in non-valvular atrial fibrillation (NVAF). NHTA agency websites were searched for HTA reports evaluating NOACs versus NOACs or vitamin K antagonists. HTA methods and information on patient involvement/access were collected and empirically analyzed. The review identified 38 unique HTA reports published between 2012 and 2017 in 16 countries including 11 in Europe. NOACs that were cost-effective per local willingness-to-pay (WTP) thresholds were positively recommended for the treatment of NVAF. WTP thresholds ranged from €20,000 to 69,000. Apixaban was recommended in 10/12 (83%) countries, dabigatran in 9/13 (69%) countries, and rivaroxaban in 10/13 (76%) over warfarin. Edoxaban was recommended in 5/7 (71%) countries. Economic evaluations and recommendations comparing NOACs were sparse (two or three countries per NOAC) and generally favored apixaban and edoxaban, followed by dabigatran. Eleven HTA reports from four countries considered the patient voice (Canada [n = 3], Scotland [n = 3], England [n = 4], Brazil [n = 1]); however, only 2/11 (18%) developed recommendations based on this. Among the reports with a positive recommendation, 26/30 (87%) featured a decision that aligned with the approved regulatory label. Most agencies recommended NOACs over warfarin for patients with NVAF. Few countries made statements recommending one NOAC over another. Given different WTP thresholds, a drug that is cost-effective in one market may not be in another. Therefore, the various NOAC recommendations from HTA agencies cannot be generalized across different countries. • A review is needed of HTA submissions of clinical and/or economic value of NOACs. • Cost-effectiveness was a major driver of recommendations based on WTP thresholds. • Different thresholds limit ability to generalize recommendations across countries. [ABSTRACT FROM AUTHOR]

This article has been corrected. The original version (PDF) is appended to this article as a Supplement.Description: The Kidney Disease: Improving Global Outcomes (KDIGO) 2018 clinical practice guideline for the prevention, diagnosis, evaluation, and treatment of hepatitis C virus (HCV) infection in chronic kidney disease (CKD) is an extensive update of KDIGO's 2008 guideline on HCV infection in CKD. This update reflects the major advances since the introduction of direct-acting antivirals (DAAs) in the management of HCV infection in the CKD population.Methods: The KDIGO work group tasked with developing the HCV and CKD guideline defined the scope of the guideline, gathered evidence, determined topics for systematic review, and graded the quality of evidence previously summarized by the evidence review team. The GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach was used to appraise the quality of evidence and rate the strength of the recommendations. Searches of the English-language literature were conducted through May 2017 and were supplemented with targeted searches for studies of DAA treatment and with abstracts from nephrology, hepatology, and transplantation conferences. A review process involving many stakeholders, subject matter experts, and industry and national organizations informed the guideline's final modification.Recommendation: The updated guideline comprises 66 recommendations. This synopsis focuses on 32 key recommendations pertinent to the prevention, diagnosis, treatment, and management of HCV infection in adult CKD populations. [ABSTRACT FROM AUTHOR]

Background: Clinical laboratories are increasingly reporting estimated glomerular filtration rate (GFR) by using serum creatinine assays traceable to a standard reference material.Purpose: To review the performance of GFR estimating equations to inform the selection of a single equation by laboratories and the interpretation of estimated GFR by clinicians.Data Sources: A systematic search of MEDLINE, without language restriction, between 1999 and 21 October 2011.Study Selection: Cross-sectional studies in adults that compared the performance of 2 or more creatinine-based GFR estimating equations with a reference GFR measurement. Eligible equations were derived or reexpressed and validated by using creatinine measurements traceable to the standard reference material.Data Extraction: Reviewers extracted data on study population characteristics, measured GFR, creatinine assay, and equation performance.Data Synthesis: Eligible studies compared the MDRD (Modification of Diet in Renal Disease) Study and CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equations or modifications thereof. In 12 studies in North America, Europe, and Australia, the CKD-EPI equation performed better at higher GFRs (approximately >60 mL/min per 1.73 m(2)) and the MDRD Study equation performed better at lower GFRs. In 5 of 8 studies in Asia and Africa, the equations were modified to improve their performance by adding a coefficient derived in the local population or removing a coefficient.Limitation: Methods of GFR measurement and study populations were heterogeneous.Conclusion: Neither the CKD-EPI nor the MDRD Study equation is optimal for all populations and GFR ranges. Using a single equation for reporting requires a tradeoff to optimize performance at either higher or lower GFR ranges. A general practice and public health perspective favors the CKD-EPI equation.Primary Funding Source: Kidney Disease: Improving Global Outcomes. [ABSTRACT FROM AUTHOR]

The 2009 Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guideline on the monitoring, management, and treatment of kidney transplant recipients is intended to assist the practitioner caring for adults and children after kidney transplantation. The guideline development process followed an evidence-based approach, and management recommendations are based on systematic reviews of relevant treatment trials. Critical appraisal of the quality of the evidence and the strength of recommendations followed the Grades of Recommendation Assessment, Development, and Evaluation (GRADE) approach. The guideline makes recommendations for immunosuppression and graft monitoring, as well as prevention and treatment of infection, cardiovascular disease, malignancy, and other complications that are common in kidney transplant recipients, including hematological and bone disorders. Limitations of the evidence, especially the lack of definitive clinical outcome trials, are discussed and suggestions are provided for future research. This summary includes a brief description of methodology and the complete guideline recommendations but does not include the rationale and references for each recommendation, which are published elsewhere. [ABSTRACT FROM AUTHOR]