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Blood May 2020There may be many predictors of venous thromboembolism (VTE) and bleeding in hospitalized medical patients, but until now, systematic reviews and assessments of the... (Meta-Analysis)
Meta-Analysis
There may be many predictors of venous thromboembolism (VTE) and bleeding in hospitalized medical patients, but until now, systematic reviews and assessments of the certainty of the evidence have not been published. We conducted a systematic review to identify prognostic factors for VTE and bleeding in hospitalized medical patients and searched Medline and EMBASE from inception through May 2018. We considered studies that identified potential prognostic factors for VTE and bleeding in hospitalized adult medical patients. Reviewers extracted data in duplicate and independently and assessed the certainty of the evidence using the Grading of Recommendations Assessment, Development, and Evaluation approach. Of 69 410 citations, we included 17 studies in our analysis: 14 that reported on VTE, and 3 that reported on bleeding. For VTE, moderate-certainty evidence showed a probable association with older age; elevated C-reactive protein (CRP), D-dimer, and fibrinogen levels; tachycardia; thrombocytosis; leukocytosis; fever; leg edema; lower Barthel Index (BI) score; immobility; paresis; previous history of VTE; thrombophilia; malignancy; critical illness; and infections. For bleeding, moderate-certainty evidence showed a probable association with older age, sex, anemia, obesity, low hemoglobin, gastroduodenal ulcers, rehospitalization, critical illness, thrombocytopenia, blood dyscrasias, hepatic disease, renal failure, antithrombotic medication, and presence of a central venous catheter. Elevated CRP, a lower BI, a history of malignancy, and elevated heart rate are not included in most VTE risk assessment models. This study informs risk prediction in the management of hospitalized medical patients for VTE and bleeding; it also informs guidelines for VTE prevention and future research.
Topics: Adult; Age Factors; Aged; Aged, 80 and over; Comorbidity; Female; Hemorrhage; Hospitalization; Humans; Male; Middle Aged; Prognosis; Risk Factors; Venous Thromboembolism
PubMed: 32092132
DOI: 10.1182/blood.2019003603 -
JB & JS Open Access 2019Understanding trends in operative times has become increasingly important in light of total hip arthroplasty (THA) being added to the Centers for Medicare & Medicaid...
UNLABELLED
Understanding trends in operative times has become increasingly important in light of total hip arthroplasty (THA) being added to the Centers for Medicare & Medicaid Services (CMS) 2019 Potentially Misvalued Codes List. The purpose of this review was to explore the mean THA operative times reported in the literature in order (1) to determine if they have increased, decreased, or remained the same for patients reported on between 2000 and 2019 and (2) to determine what factors might have contributed to the difference (or lack thereof) in THA operative time over a contemporary study period.
METHODS
The PubMed and EBSCOhost databases were queried to identify all articles, published between 2000 and 2019, that reported on THA operative times. The keywords used were "operative," "time," and "total hip arthroplasty." An article was included if the full text was available, it was written in English, and it reported operative times of THAs. An article was excluded if it did not discuss operative time; it reported only comparative, rather than absolute, operative times; or the cohort consisted of total knee arthroplasties (TKAs) and THAs, exclusively of revision THAs, or exclusively of robotic THAs. Data on manual or primary THAs were extracted from studies including robotic or revision THAs. Thirty-five articles reporting on 630,675 hips that underwent THA between 1996 and 2016 met our criteria.
RESULTS
The overall weighted average operative time was 93.20 minutes (range, 55.65 to 149.00 minutes). When the study cohorts were stratified according to average operative time, the highest number fell into the 90 to 99-minute range. Operative time was stable throughout the years reported. Factors that led to increased operative times included increased body mass index (BMI), less surgical experience, and the presence of a trainee.
CONCLUSIONS
The average operative time across the included articles was approximately 95 minutes and has been relatively stable over the past 2 decades. On the basis of our findings, we cannot support CMS lowering the procedural valuation of THA given the stability of its operative times and the relationship between operative time and cost.
PubMed: 32043063
DOI: 10.2106/JBJS.OA.19.00047 -
BMJ (Clinical Research Ed.) Feb 2020To conduct a systematic review and meta-analysis of the effects of rosiglitazone treatment on cardiovascular risk and mortality using multiple data sources and varying... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
To conduct a systematic review and meta-analysis of the effects of rosiglitazone treatment on cardiovascular risk and mortality using multiple data sources and varying analytical approaches with three aims in mind: to clarify uncertainties about the cardiovascular risk of rosiglitazone; to determine whether different analytical approaches are likely to alter the conclusions of adverse event meta-analyses; and to inform efforts to promote clinical trial transparency and data sharing.
DESIGN
Systematic review and meta-analysis of randomized controlled trials.
DATA SOURCES
GlaxoSmithKline's (GSK's) ClinicalStudyDataRequest.com for individual patient level data (IPD) and GSK's Study Register platforms, MEDLINE, PubMed, Embase, Web of Science, Cochrane Central Registry of Controlled Trials, Scopus, and ClinicalTrials.gov from inception to January 2019 for summary level data.
ELIGIBILITY CRITERIA FOR SELECTING STUDIES
Randomized, controlled, phase II-IV clinical trials that compared rosiglitazone with any control for at least 24 weeks in adults.
DATA EXTRACTION AND SYNTHESIS
For analyses of trials for which IPD were available, a composite outcome of acute myocardial infarction, heart failure, cardiovascular related death, and non-cardiovascular related death was examined. These four events were examined independently as secondary analyses. For analyses including trials for which IPD were not available, myocardial infarction and cardiovascular related death were examined, which were determined from summary level data. Multiple meta-analyses were conducted that accounted for trials with zero events in one or both arms with two different continuity corrections (0.5 constant and treatment arm) to calculate odds ratios and risk ratios with 95% confidence intervals.
RESULTS
33 eligible trials were identified from ClinicalStudyDataRequest.com for which IPD were available (21 156 patients). Additionally, 103 trials for which IPD were not available were included in the meta-analyses for myocardial infarction (23 683 patients), and 103 trials for which IPD were not available contributed to the meta-analyses for cardiovascular related death (22 772 patients). Among 29 trials for which IPD were available and that were included in previous meta-analyses using GSK's summary level data, more myocardial infarction events were identified by using IPD instead of summary level data for 26 trials, and fewer cardiovascular related deaths for five trials. When analyses were limited to trials for which IPD were available, and a constant continuity correction of 0.5 and a random effects model were used to account for trials with zero events in only one arm, patients treated with rosiglitazone had a 33% increased risk of a composite event compared with controls (odds ratio 1.33, 95% confidence interval 1.09 to 1.61; rosiglitazone population: 274 events among 11 837 patients; control population: 219 events among 9319 patients). The odds ratios for myocardial infarction, heart failure, cardiovascular related death, and non-cardiovascular related death were 1.17 (0.92 to 1.51), 1.54 (1.14 to 2.09), 1.15 (0.55 to 2.41), and 1.18 (0.60 to 2.30), respectively. For analyses including trials for which IPD were not available, odds ratios for myocardial infarction and cardiovascular related death were attenuated (1.09, 0.88 to 1.35, and 1.12, 0.72 to 1.74, respectively). Results were broadly consistent when analyses were repeated using trials with zero events across both arms and either of the two continuity corrections was used.
CONCLUSIONS
The results suggest that rosiglitazone is associated with an increased cardiovascular risk, especially for heart failure events. Although increased risk of myocardial infarction was observed across analyses, the strength of the evidence varied and effect estimates were attenuated when summary level data were used in addition to IPD. Because more myocardial infarctions and fewer cardiovascular related deaths were reported in the IPD than in the summary level data, sharing IPD might be necessary when performing meta-analyses focused on safety.
SYSTEMATIC REVIEW REGISTRATION
OSF Home https://osf.io/4yvp2/.
Topics: Cardiovascular Diseases; Humans; Hypoglycemic Agents; Information Dissemination; Randomized Controlled Trials as Topic; Risk Factors; Rosiglitazone
PubMed: 32024657
DOI: 10.1136/bmj.l7078 -
American Journal of Preventive Medicine Apr 2020The Patient Protection and Affordable Care Act increases healthcare access and includes provisions that directly impact access to and cost of evidence-based colorectal...
CONTEXT
The Patient Protection and Affordable Care Act increases healthcare access and includes provisions that directly impact access to and cost of evidence-based colorectal cancer screening. The Affordable Care Act's removal of cost sharing for colorectal cancer screening as well as Medicaid expansion have been hypothesized to increase screening and improve other health outcomes. However, since its passage in 2010, there is little consensus on the Affordable Care Act's impact.
EVIDENCE ACQUISITION
Data from March 2010 to June 2019 were reviewed and 21 relevant studies were identified; 19 studies examined colorectal cancer screening with most finding increased screening rates.
EVIDENCE SYNTHESIS
Eleven studies found significant increases, 5 found nonsignificant increases, 3 found nonsignificant decreases, and 1 study found a significant decrease in colorectal cancer screening. Three studies examined the impact on colorectal cancer incidence and stage of diagnosis, where a significant 2.4% increase in early diagnosis was found in one and a nonsignificant increase in incidence in another. However, survival improved after Medicaid expansion.
CONCLUSIONS
Free preventive colorectal cancer screening and Medicaid expansion because of passage of the Affordable Care Act have been, in general, positively associated with modest improvements in screening rates across the country. Future studies are needed that investigate the longer-term impact of the Affordable Care Act on colorectal cancer morbidity and mortality rates, as screening is only the first step in treatment of cancerous and precancerous lesions, preventing them from progressing. Moreover, more studies examining subpopulations are needed to better assess where gaps in care remain.
Topics: Cancer Survivors; Colorectal Neoplasms; Early Detection of Cancer; Health Services Accessibility; Healthcare Disparities; Humans; Insurance Coverage; Medicaid; Patient Protection and Affordable Care Act; United States
PubMed: 32008799
DOI: 10.1016/j.amepre.2019.11.018 -
JAMA Jan 2020The tort liability system is intended to serve 3 functions: compensate patients who sustain injury from negligence, provide corrective justice, and deter negligence....
IMPORTANCE
The tort liability system is intended to serve 3 functions: compensate patients who sustain injury from negligence, provide corrective justice, and deter negligence. Deterrence, in theory, occurs because clinicians know that they may experience adverse consequences if they negligently injure patients.
OBJECTIVE
To review empirical findings regarding the association between malpractice liability risk (ie, the extent to which clinicians face the threat of being sued and having to pay damages) and health care quality and safety.
DATA SOURCES AND STUDY SELECTION
Systematic search of multiple databases for studies published between January 1, 1990, and November 25, 2019, examining the relationship between malpractice liability risk measures and health outcomes or structural and process indicators of health care quality.
DATA EXTRACTION AND SYNTHESIS
Information on the exposure and outcome measures, results, and acknowledged limitations was extracted by 2 reviewers. Meta-analytic pooling was not possible due to variations in study designs; therefore, studies were summarized descriptively and assessed qualitatively.
MAIN OUTCOMES AND MEASURES
Associations between malpractice risk measures and health care quality and safety outcomes. Exposure measures included physicians' malpractice insurance premiums, state tort reforms, frequency of paid claims, average claim payment, physicians' claims history, total malpractice payments, jury awards, the presence of an immunity from malpractice liability, the Centers for Medicare & Medicaid Services' Medicare malpractice geographic practice cost index, and composite measures combining these measures. Outcome measures included patient mortality; hospital readmissions, avoidable admissions, and prolonged length of stay; receipt of cancer screening; Agency for Healthcare Research and Quality patient safety indicators and other measures of adverse events; measures of hospital and nursing home quality; and patient satisfaction.
RESULTS
Thirty-seven studies were included; 28 examined hospital care only and 16 focused on obstetrical care. Among obstetrical care studies, 9 found no significant association between liability risk and outcomes (such as Apgar score and birth injuries) and 7 found limited evidence for an association. Among 20 studies of patient mortality in nonobstetrical care settings, 15 found no evidence of an association with liability risk and 5 found limited evidence. Among 7 studies that examined hospital readmissions and avoidable initial hospitalizations, none found evidence of an association between liability risk and outcomes. Among 12 studies of other measures (eg, patient safety indicators, process-of-care quality measures, patient satisfaction), 7 found no association between liability risk and these outcomes and 5 identified significant associations in some analyses.
CONCLUSIONS AND RELEVANCE
In this systematic review, most studies found no association between measures of malpractice liability risk and health care quality and outcomes. Although gaps in the evidence remain, the available findings suggested that greater tort liability, at least in its current form, was not associated with improved quality of care.
Topics: Humans; Insurance, Liability; Liability, Legal; Malpractice; Obstetrics; Outcome Assessment, Health Care; Postoperative Complications; Quality of Health Care
PubMed: 31990319
DOI: 10.1001/jama.2019.21411 -
Population Health Management Apr 2020A limited number of patients, commonly termed super-utilizers, account for the bulk of health care expenditures. Multiple criteria for identifying super-utilizers exist,...
A limited number of patients, commonly termed super-utilizers, account for the bulk of health care expenditures. Multiple criteria for identifying super-utilizers exist, but no standard methodology is available for determining which criteria should be used for a specific population. Application is often arbitrary, and poorly aligned super-utilizer criteria might result in misallocation of resources and diminished effects of interventions. This study sought to apply an innovative, data-driven approach to classify super-utilizers among Utah Medicaid beneficiaries. The authors conducted a literature review of research methods to catalogue applied super-utilizer criteria. The most commonly used criteria were applied to Utah Medicaid beneficiaries enrolled during July 1, 2016-June 30, 2017, using their previous 12 months of claims data (N = 309,921). The -medoids algorithm cluster analysis was used to find groups of beneficiaries with similar characteristic based on criteria from the literature. In all, 180 super-utilizer criteria were identified in the literature, 21 of which met the inclusion criteria. When these criteria were applied to Utah Medicaid data, 5 distinct subpopulation clusters were found: non-super-utilizers (n = 163,118), beneficiaries with multiple chronic or mental health conditions (n = 68,054), beneficiaries with a single chronic health condition (n = 43,939), emergency department super-utilizers with chronic or mental health conditions (n = 7809), and beneficiaries with uncomplicated hospitalizations (n = 27,001). This study demonstrates how cluster analysis can aid in selecting characteristics from the literature that systematically differentiate super-utilizer groups from other beneficiaries. This methodology might be useful to health care systems for identifying super-utilizers within their patient populations.
Topics: Chronic Disease; Cluster Analysis; Databases, Factual; Emergency Service, Hospital; Health Services Misuse; Humans; Medicaid; Mental Disorders; United States; Utah
PubMed: 31424319
DOI: 10.1089/pop.2019.0076 -
Journal of General Internal Medicine Oct 2019Changing Medicaid fees is a common approach for states to address budget fluctuations, and many currently set Medicaid physician fees at levels lower than Medicare and...
BACKGROUND
Changing Medicaid fees is a common approach for states to address budget fluctuations, and many currently set Medicaid physician fees at levels lower than Medicare and private insurers. The Affordable Care Act included a temporary Medicaid fee bump for primary care providers (PCPs) in 2013-2014 that recently led to both an increase and then subsequent decrease in PCP fees in many states.
OBJECTIVE
To conduct a systematic literature review on the effects of changing Medicaid fees on provider participation and enrollees' access to care and service use.
METHODS
We searched PubMed/Medline and JSTOR and identified 18 studies that assessed the longitudinal impact of provider fee changes in Medicaid on the outcomes of interest. We summarized information on study design, methods, and findings.
RESULTS
Seven studies examined the impact of fee changes on provider participation in Medicaid. Of these, three studies found that fee increases were associated with positive effects on providers' likelihood of accepting Medicaid patients or on their Medicaid caseloads. Five studies that examined the impact of fee changes on Medicaid enrollees' access to care found a positive association with one or more access measure, such as having a usual source of care or appointment availability. Lastly, eight of 14 studies that examined service use found positive associations between fee changes and at least one measure of use, such as changes in the probability of enrollees having any visit, the number of visits, and shifts in the site of care toward office-based care; others largely did not find significant associations.
CONCLUSIONS
There is mixed evidence on the impact of changing Medicaid fees on provider participation and enrollees' service use; however, increasing fees appears to have more consistent positive effects on access to care. Whether these improvements in access translate into better health outcomes or downstream cost savings are critical questions.
Topics: Fees and Charges; Health Services Accessibility; Humans; Medicaid; Patient Protection and Affordable Care Act; United States
PubMed: 31388912
DOI: 10.1007/s11606-019-05160-x -
Critical Care Medicine Oct 2019To address three controversial components in the Centers for Medicare and Medicaid Service's sepsis bundle for performance measure (SEP-1): antibiotics within 3 hours, a...
Antibiotic- and Fluid-Focused Bundles Potentially Improve Sepsis Management, but High-Quality Evidence Is Lacking for the Specificity Required in the Centers for Medicare and Medicaid Service's Sepsis Bundle (SEP-1).
OBJECTIVE
To address three controversial components in the Centers for Medicare and Medicaid Service's sepsis bundle for performance measure (SEP-1): antibiotics within 3 hours, a 30 mL/kg fluid infusion for all hypotensive patients, and repeat lactate measurements within 6 hours if initially elevated. We hypothesized that antibiotic- and fluid-focused bundles like SEP-1 would probably show benefit, but evidence supporting specific antibiotic timing, fluid dosing, or serial lactate requirements would not be concordant. Therefore, we performed a meta-analysis of studies of sepsis bundles like SEP-1.
DATA SOURCES
PubMed, Embase, ClinicalTrials.gov through March 15, 2018.
STUDY SELECTION
Studies comparing survival in septic adults receiving versus not receiving antibiotic- and fluid-focused bundles.
DATA EXTRACTION
Two investigators (D.J.P., P.Q.E.).
DATA SYNTHESIS
Seventeen observational studies (11,303 controls and 4,977 bundle subjects) met inclusion criteria. Bundles were associated with increased odds ratios of survival (odds ratio [95% CI]) in 15 studies with substantial heterogeneity (I = 61%; p < 0.01). Survival benefits were consistent in the five largest (1,697-12,486 patients per study) (1.20 [1.11-1.30]; I = 0%) and six medium-sized studies (167-1,029) (2.03 [1.52-2.71]; I = 8%) but not the six smallest (64-137) (1.25 [0.42-3.66]; I = 57%). Bundles were associated with similarly increased survival benefits whether requiring antibiotics within 1 hour (n = 7 studies) versus 3 hours (n = 8) versus no specified time (n = 2); or 30 mL/kg fluid (n = 7) versus another volume (≥ 2 L, n = 1; ≥ 20 mL/kg, n = 2; 1.5-2 L or 500 mL, n = 1 each; none specified, n = 4) (p = 0.19 for each comparison). In the only study employing serial lactate measurements, survival was not increased versus others. No study had a low risk of bias or assessed potential adverse bundle effects.
CONCLUSIONS
Available studies support the notion that antibiotic- and fluid-focused sepsis bundles like SEP-1 improve survival but do not demonstrate the superiority of any specific antibiotic time or fluid volume or of serial lactate measurements. Until strong reproducible evidence demonstrates the safety and benefit of any fixed requirement for these interventions, the present findings support the revision of SEP-1 to allow flexibility in treatment according to physician judgment.
Topics: Anti-Bacterial Agents; Fluid Therapy; Humans; Medicaid; Medicare; Patient Care Bundles; Quality Indicators, Health Care; Sepsis; United States
PubMed: 31369426
DOI: 10.1097/CCM.0000000000003892 -
Clinical and Applied... 2019
Topics: Cardiac Tamponade; Databases, Factual; Humans; Pericardial Effusion; Vena Cava Filters
PubMed: 31088147
DOI: 10.1177/1076029619849111 -
Journal of Public Health Research Mar 2019This study tested the hypothesis that socioeconomically vulnerable Canadians with diverse acute conditions or chronic diseases have health care access and survival...
This study tested the hypothesis that socioeconomically vulnerable Canadians with diverse acute conditions or chronic diseases have health care access and survival advantages over their counterparts in the USA. A rapid systematic review retrieved 25 studies (34 independent cohorts) published between 2003 and 2018. They were synthesized with a streamlined meta-analysis. Very low-income Canadian patients were consistently and highly advantaged in terms of health care access and survival compared with their counterparts in the USA who lived in poverty and/or were uninsured or underinsured. In aggregate and controlling for specific conditions or diseases and typically 4 to 9 comorbid factors or biomarkers, Canadians' chances of receiving better health care were estimated to be 36% greater than their American counterparts (RR=1.36, 95% CI 1.35-1.37). This estimate was significantly larger than that based on general patient or non-vulnerable population comparisons (RR=1.09, 95% CI 1.08-1.10). Contrary to prevalent political rhetoric, three studies observed that Americans experience more than twice the risk of long waits for breast or colon cancer care or of dying while they wait for an organ transplant (RR=2.36, 95% CI 2.09-2.66). These findings were replicated across externally valid national studies and more internally valid, metropolitan or provincial/state comparisons. Socioeconomically vulnerable Canadians are consistently and highly advantaged on health care access and outcomes compared to their American counterparts. Less vulnerable comparisons found more modest Canadian advantages. The Affordable Care Act ought to be fully supported including the expansion of Medicaid across all states. Canada's single payer system ought to be maintained and strengthened, but not through privatization.
PubMed: 30997359
DOI: 10.4081/jphr.2019.1479