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Article ; Online: Summarizing the evidence of the benefit of surgical simulation in gynecologic surgery.

Orejuela, Francisco J / Balk, Ethan M

American journal of obstetrics and gynecology

2022 Volume 227, Issue 6, Page(s) 930–931

MeSH term(s)	Female ; Humans ; Gynecologic Surgical Procedures ; Robotic Surgical Procedures ; Computer Simulation
Language	English
Publishing date	2022-08-18
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	80016-8
ISSN	1097-6868 ; 0002-9378
ISSN (online)	1097-6868
ISSN	0002-9378
DOI	10.1016/j.ajog.2022.08.022
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Article ; Online: Untangling the Gordian Knot of Vitamin D Supplementation and Type 2 Diabetes Prevention.

Pittas, Anastassios G / Balk, Ethan M

Diabetes care

2021 Volume 43, Issue 7, Page(s) 1375–1377

MeSH term(s)	Diabetes Mellitus, Type 2/prevention & control ; Dietary Supplements ; Humans ; Insulin Resistance ; Vitamin D
Chemical Substances	Vitamin D (1406-16-2)
Language	English
Publishing date	2021-05-25
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Comment
ZDB-ID	441231-x
ISSN	1935-5548 ; 0149-5992
ISSN (online)	1935-5548
ISSN	0149-5992
DOI	10.2337/dci20-0011
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Zs.A 1434: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Vitamin D and Risk for Type 2 Diabetes in People With Prediabetes.

Pittas, Anastassios G / Kawahara, Tetsuya / Jorde, Rolf / Dawson-Hughes, Bess / Balk, Ethan M

Annals of internal medicine

2023 Volume 176, Issue 8, Page(s) eL230202

Language	English
Publishing date	2023-08-15
Publishing country	United States
Document type	Journal Article
ZDB-ID	336-0
ISSN	1539-3704 ; 0003-4819
ISSN (online)	1539-3704
ISSN	0003-4819
DOI	10.7326/L23-0202
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Article ; Online: Large variability in definitions of sleep apnea indices used in clinical studies.

Balk, Ethan M / Adam, Gaelen P / D'Ambrosio, Carolyn M

Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine

2023 Volume 20, Issue 3, Page(s) 461–468

Abstract: ... whether studies are generalizable from one setting to another.: Citation: Balk EM, Adam GP, D'Ambrosio CM ...

Abstract	Study objectives: We explored the variability of sleep apnea indices and definitions of obstructive sleep apnea in clinical studies of continuous positive airway pressure. Methods: In a systematic review of the long-term clinical effects of continuous positive airway pressure, we noted variability across studies in how sleep apnea was defined. We, thus, sought to quantify the heterogeneity. Results: Across 57 comparative studies of long-term clinical outcomes of continuous positive airway pressure, only 40% fully and explicitly reported their definitions of apnea and hypopnea. Most studies defined apnea as 100% airflow cessation, but a minority used 90% or even down to 75% thresholds. Almost half of the studies defined hypopnea as ≥ 50% airflow cessation, but the majority used 30% or even 25% thresholds. Similarly, about half of the studies used a 4% desaturation threshold to define oxygen desaturation and about half used a 3% threshold, with 2 studies using both thresholds for different purposes. Randomized trials were no more consistent or better-reported than observational studies. Studies that cited published criteria generally reported definitions that were different from the cited criteria. Conclusions: The criteria used to define sleep apnea indices (apnea, hypopnea, and oxygen desaturation) were highly variable, even among studies stating that definitions were based on the same standard criteria. It was often difficult to discern the actual criteria used. The great variability across studies and lack of transparency about their sleep study methods hampers the interpretability and utility of the studies and calls into question whether studies are generalizable from one setting to another. Citation: Balk EM, Adam GP, D'Ambrosio CM. Large variability in definitions of sleep apnea indices used in clinical studies.
MeSH term(s)	Humans ; Sleep Apnea Syndromes/diagnosis ; Sleep ; Sleep Apnea, Obstructive/diagnosis ; Sleep Apnea, Obstructive/therapy ; Polysomnography ; Oxygen
Chemical Substances	Oxygen (S88TT14065)
Language	English
Publishing date	2023-12-06
Publishing country	United States
Document type	Systematic Review ; Journal Article
ZDB-ID	2397213-0
ISSN	1550-9397 ; 1550-9389
ISSN (online)	1550-9397
ISSN	1550-9389
DOI	10.5664/jcsm.10918
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Article ; Online: Long-term effects on clinical event, mental health, and related outcomes of CPAP for obstructive sleep apnea: a systematic review.

Balk, Ethan M / Adam, Gaelen P / Cao, Wangnan / Bhuma, Monika Reddy / D'Ambrosio, Carolyn / Trikalinos, Thomas A

Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine

2024

Abstract: Study objectives: Systematic review of long-term health outcomes of continuous positive airway pressure (CPAP) use in adults with obstructive sleep apnea.: Methods: We updated prior systematic reviews with searches in multiple databases through ... ...

Abstract	Study objectives: Systematic review of long-term health outcomes of continuous positive airway pressure (CPAP) use in adults with obstructive sleep apnea. Methods: We updated prior systematic reviews with searches in multiple databases through January 3, 2023. We included randomized controlled trials (RCTs) and adjusted nonrandomized comparative studies (NRCSs) that reported specified long-term (mostly >1 year) health outcomes. We assessed risk of bias, conducted meta-analyses, and evaluated strength of evidence. Results: We found 38 eligible studies (16 trials, 28 observational). All conclusions were of low strength of evidence given study and data limitations. RCTs found no evidence of effect of CPAP on mortality (summary effect size [ES] 0.89; 95% CI 0.66, 1.21); inclusion of adjusted NRCSs yields an association with reduced risk of death (ES 0.57; 95% CI 0.44, 0.73). RCTs found no evidence of effects of CPAP for cardiovascular death (ES 0.99; 95% CI 0.64, 1.53), stroke (ES 0.99; 95% CI 0.73, 1.35), myocardial infarction (ES 1.05; 95% CI 0.78, 1.41), incident atrial fibrillation (ES 0.89; 95% CI 0.48, 1.63), and composite cardiovascular outcomes (all statistically nonsignificant). RCTs found no evidence of effects for incident diabetes (ES 1.02; 95% CI 0.69, 1.51) and accidents (all nonsignificant), and no clinically significant effects on depressive symptoms, anxiety symptoms, or cognitive function. Conclusions: Whether CPAP use for obstructive sleep apnea affects long-term health outcomes remains largely unanswered. RCTs and NRCSs are inconsistent regarding the effect of CPAP on mortality. Current studies are underpowered, with relatively short duration follow-up and methodological limitations.
Language	English
Publishing date	2024-02-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	2397213-0
ISSN	1550-9397 ; 1550-9389
ISSN (online)	1550-9397
ISSN	1550-9389
DOI	10.5664/jcsm.11030
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Article ; Online: Kidney Transplantation From Hepatitis C Virus-Infected Donors to Uninfected Recipients: A Systematic Review for the KDIGO 2022 Hepatitis C Clinical Practice Guideline Update.

Gordon, Craig E / Adam, Gaelen P / Jadoul, Michel / Martin, Paul / Balk, Ethan M

American journal of kidney diseases : the official journal of the National Kidney Foundation

2023 Volume 82, Issue 4, Page(s) 410–418

Abstract: Rationale & objective: Direct-acting antiviral (DAA) treatment of hepatitis C virus (HCV) infection in patients with chronic kidney disease (CKD) has made transplantation of kidneys from HCV-infected donors to uninfected recipients (D+/R-) feasible. To ... ...

Abstract	Rationale & objective: Direct-acting antiviral (DAA) treatment of hepatitis C virus (HCV) infection in patients with chronic kidney disease (CKD) has made transplantation of kidneys from HCV-infected donors to uninfected recipients (D+/R-) feasible. To facilitate an update to the 2018 KDIGO guideline for patients with CKD and HCV, we conducted a systematic review of HCV D+/R-kidney transplantation coupled with DAA treatment. Study design: Systematic review and meta-analysis. Setting & study populations: We included studies of HCV D+/R-kidney transplantations that used any DAA protocol. Selection criteria for studies: Based on a search of PubMed, Embase, Cochrane, CINAHL, and ClinicalTrials.gov through February 1, 2022, conferences from 2019 to 2021, and the 2018 KDIGO HCV guideline we identified single-group (D+/R-) or comparative studies of D+/R-versus D-/R-kidney transplantation. Data extraction: Conducted in SRDR-Plus with review by a second researcher. Analytical approach: Maximum likelihood meta-analyses; the certainty of evidence was assessed per GRADE (Grading of Recommendations Assessment, Development and Evaluation). Results: We identified 16 studies (N=557). A sustained viral response at 12 weeks after treatment (SVR12) was observed in 97.7% (95% CI, 96.3%-98.8%). Ultrashort duration treatment (≤8 days) resulted in viremia requiring standard-course DAA treatment in some patients, all of whom achieved SVR12 after 1 or rarely 2 DAA courses. Serious adverse events from DAA treatment were rare after D+/R-transplantation (0.4% [95% CI, 0.1%-2.8%]). At≥1 year after D+/R-transplantation, recipient death occurred in 2.1% (95% CI, 0.9-3.7) and allograft survival was 97.6% (95% CI, 95.7%-98.9%). Estimated glomerular filtration rate 1 year after transplantation ranged from 46 to 74mL/min/1.73m Limitations: Analyses were generally based on low-certainty evidence. Uncertainty exists about the long-term safety and efficacy of D+/R-transplantation. Few studies investigated ultrashort treatment courses. Conclusions: Kidney transplantation from HCV-infected donors to uninfected recipients followed by DAA treatment appears to be safe and associated with excellent 1-year clinical outcomes. Plain-language summary: Due to the high efficacy of direct-acting antivirals (DAA), the use of kidneys from HCV-infected deceased donors may increase rates of kidney transplantation. We conducted a systematic review for the 2022 KDIGO Clinical Practice Guideline on Hepatitis C to evaluate the safety and efficacy of kidney transplantation from HCV-infected donors to uninfected recipients (D+/R-) followed by DAA therapy. Sixteen studies comprising 557 patients revealed high rates of sustained viral response, low rates of adverse events, and excellent patient and allograft survival 1 year after transplantation. Kidney transplantation from HCV-infected deceased donors to uninfected recipients treated with DAA appears safe and effective. Future studies should investigate shorter treatment durations, monitor safety, and obtain longer-term efficacy data.
MeSH term(s)	Humans ; Antiviral Agents/therapeutic use ; Hepacivirus ; Kidney Transplantation ; Hepatitis C, Chronic/complications ; Hepatitis C/complications ; Renal Insufficiency, Chronic/complications ; Tissue Donors
Chemical Substances	Antiviral Agents
Language	English
Publishing date	2023-04-14
Publishing country	United States
Document type	Meta-Analysis ; Systematic Review ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	604539-x
ISSN	1523-6838 ; 0272-6386
ISSN (online)	1523-6838
ISSN	0272-6386
DOI	10.1053/j.ajkd.2022.12.019
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Zs.A 1669: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Long-Term Health Outcomes in Women With Silicone Gel Breast Implants.

Balk, Ethan M / Raman, Gowri

Annals of internal medicine

2016 Volume 165, Issue 7, Page(s) 527–528

Language	English
Publishing date	2016-10-04
Publishing country	United States
Document type	Journal Article
ZDB-ID	336-0
ISSN	1539-3704 ; 0003-4819
ISSN (online)	1539-3704
ISSN	0003-4819
DOI	10.7326/L16-0196
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Article ; Online: A Systematic Review of Direct-Acting Antivirals for Hepatitis C in Advanced CKD.

Balk, Ethan M / Adam, Gaelen P / Jadoul, Michel / Martin, Paul / Gordon, Craig E

Kidney international reports

2022 Volume 8, Issue 2, Page(s) 240–253

Abstract: Introduction: Direct-acting antivirals (DAAs) have improved treatment of hepatitis C virus (HCV) infection in patients with chronic kidney disease (CKD). To facilitate the 2022 update of the Kidney Disease: Improving Global Outcomes (KDIGO) guideline ... ...

Abstract	Introduction: Direct-acting antivirals (DAAs) have improved treatment of hepatitis C virus (HCV) infection in patients with chronic kidney disease (CKD). To facilitate the 2022 update of the Kidney Disease: Improving Global Outcomes (KDIGO) guideline for CKD patients with HCV, we systematically reviewed DAA regimens in patients with CKD stages G4 and G5 nondialysis (G4-G5ND), CKD stage G5 on dialysis (G5D), and kidney transplant recipients (KTRs). Methods: We conducted a systematic review by searching PubMed, Embase, Cochrane, CINAHL, and ClinicalTrials.gov through February 1, 2022, and conferences from 2019 to 2021. Studies of HCV-infected patients with CKD G4-G5ND, G5D, and KTRs treated with specified DAA regimens were included. Outcomes included death at 6 months or later, sustained virologic response at 12 weeks (SVR12), serious adverse events (SAEs) attributed to DAA, and treatment discontinuation because of adverse events. Maximum likelihood meta-analyses were determined; certainty of evidence was assessed per GRADE (Grading of Recommendations Assessment, Development, and Evaluation). Results: We identified 106 eligible studies (22 reported on CKD G4-G5ND, 69 on CKD G5D, and 29 on KTRs). In each population, the majority of DAA regimens achieved SVR12 ≥ 93%. We found generally low quality of evidence of low risk of SAEs (mostly 0%, up to 2.9%) and low risk of discontinuation because of adverse events (mostly 0%-5%). Across 3 unadjusted observational studies in KTRs, the risk of death after DAA treatment was substantially lower than without treatment (summary odds ratio, 0.16; 95% CI, 0.04-0.61). Conclusion: Combination DAA regimens are safe and highly effective in patients with advanced CKD, on dialysis, and with kidney transplants.
Language	English
Publishing date	2022-12-01
Publishing country	United States
Document type	Journal Article
ISSN	2468-0249
ISSN (online)	2468-0249
DOI	10.1016/j.ekir.2022.11.008
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Article ; Online: Approaches to Assessing and Adjusting for Selective Outcome Reporting in Meta-analysis.

Jackson, Jeffrey L / Balk, Ethan M / Hyun, Noorie / Kuriyama, Akira

Journal of general internal medicine

2021 Volume 37, Issue 5, Page(s) 1247–1253

Abstract: Background: Selective or non-reporting of study outcomes results in outcome reporting bias.: Objective: We sought to develop and assess tools for detecting and adjusting for outcome reporting bias.: Design: Using data from a previously published ... ...

Abstract	Background: Selective or non-reporting of study outcomes results in outcome reporting bias. Objective: We sought to develop and assess tools for detecting and adjusting for outcome reporting bias. Design: Using data from a previously published systematic review, we abstracted whether outcomes were reported as collected, whether outcomes were statistically significant, and whether statistically significant outcomes were more likely to be reported. We proposed and tested a model to adjust for unreported outcomes and compared our model to three other methods (Copas, Frosi, trim and fill). Our approach assumes that unreported outcomes had a null intervention effect with variance imputed based on the published outcomes. We further compared our approach to these models using simulation, and by varying levels of missing data and study sizes. Results: There were 286 outcomes reported as collected from 47 included trials: 142 (48%) had the data provided and 144 (52%) did not. Reported outcomes were more likely to be statistically significant than those collected but for which data were unreported and for which non-significance was reported (RR, 2.4; 95% CI, 1.9 to 3.0). Our model and the Copas model provided similar decreases in the pooled effect sizes in both the meta-analytic data and simulation studies. The Frosi and trim and fill methods performed poorly. Limitations: Single intervention of a single disease with only randomized controlled trials; approach may overestimate outcome reporting bias impact. Conclusion: There was evidence of selective outcome reporting. Statistically significant outcomes were more likely to be published than non-significant ones. Our simple approach provided a quick estimate of the impact of unreported outcomes on the estimated effect. This approach could be used as a quick assessment of the potential impact of unreported outcomes.
MeSH term(s)	Bias ; Computer Simulation ; Humans ; Meta-Analysis as Topic ; Publication Bias
Language	English
Publishing date	2021-10-19
Publishing country	United States
Document type	Journal Article
ZDB-ID	639008-0
ISSN	1525-1497 ; 0884-8734
ISSN (online)	1525-1497
ISSN	0884-8734
DOI	10.1007/s11606-021-07135-3
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Article ; Online: Evaluation and Management After Acute Left-Sided Colonic Diverticulitis : A Systematic Review.

Balk, Ethan M / Adam, Gaelen P / Cao, Wangnan / Mehta, Shivani / Shah, Nishit

Annals of internal medicine

2022 Volume 175, Issue 3, Page(s) 388–398

Abstract: Background: The value of interventions used after acute colonic diverticulitis is unclear.: Purpose: To evaluate postdiverticulitis colonoscopy and interventions to prevent recurrent diverticulitis.: Data sources: MEDLINE, Cochrane Central ... ...

Abstract	Background: The value of interventions used after acute colonic diverticulitis is unclear. Purpose: To evaluate postdiverticulitis colonoscopy and interventions to prevent recurrent diverticulitis. Data sources: MEDLINE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Embase, CINAHL, and ClinicalTrials.gov from 1 January 1990 through 16 November 2020. Study selection: Comparative studies of interventions of interest reporting critical or important outcomes, and larger single-group studies to evaluate prevalence of colonoscopy findings and harms. Data extraction: 6 researchers extracted study data and risk of bias. The team assessed strength of evidence. Data synthesis: 19 studies evaluated colonoscopy. Risk for prevalent colorectal cancer (CRC) compared with the general population is unclear. Based on low-strength evidence, long-term CRC diagnosis is similar with or without colonoscopy. High-strength evidence indicates that risk for prevalent CRC is higher among patients with complicated diverticulitis and colonoscopy complications are rare. Based on high-strength evidence, mesalamine does not reduce recurrence risk (6 randomized controlled trials [RCTs]). Evidence on other nonsurgical interventions is insufficient. For patients with prior complicated or smoldering or frequently recurrent diverticulitis, elective surgery is associated with reduced recurrence (3 studies; high strength). In 19 studies, serious surgical complications were uncommon. Limitations: Few RCTs provided evidence. Heterogeneity of treatment effect was not adequately assessed. Conclusion: It is unclear whether patients with recent acute diverticulitis are at increased risk for prevalent CRC, but those with complicated diverticulitis are at increased risk. Mesalamine is ineffective in preventing recurrence; other nonsurgical treatments have inadequate evidence. Elective surgery reduces recurrence in patients with prior complicated or smoldering or frequently recurrent diverticulitis, but it is unclear which of these patients may benefit most. Primary funding source: Agency for Healthcare Research and Quality and American College of Physicians. (PROSPERO: CRD42020151246).
MeSH term(s)	Colonoscopy ; Diverticulitis/surgery ; Diverticulitis, Colonic/complications ; Diverticulitis, Colonic/diagnosis ; Diverticulitis, Colonic/therapy ; Humans ; Mesalamine ; United States
Chemical Substances	Mesalamine (4Q81I59GXC)
Language	English
Publishing date	2022-01-18
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, P.H.S. ; Systematic Review
ZDB-ID	336-0
ISSN	1539-3704 ; 0003-4819
ISSN (online)	1539-3704
ISSN	0003-4819
DOI	10.7326/M21-1646
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