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Mayo Clinic Proceedings. Innovations,... Apr 2021To systematically evaluate the prevalence of disclosed and undisclosed financial conflicts of interest (FCOI) among clinical practice guidelines (CPGs). (Review)
Review
OBJECTIVE
To systematically evaluate the prevalence of disclosed and undisclosed financial conflicts of interest (FCOI) among clinical practice guidelines (CPGs).
METHODS
In this systematic review, we ascertained the prevalence and types of FCOI for CPGs from January 1, 1980, to March 3, 2019. The primary outcome was the prevalence of FCOI among authors of CPGs. FCOI disclosures were compared between medical subspecialties and societies producing CPGs.
RESULTS
Among the 37 studies including 14,764 total guideline authors, 45% had at least one FCOI. The prevalence of FCOI per study ranged from 6% to 100%. More authors had FCOI involving general payments (39%) compared with research payments (29%). Oncology, neurology, and gastroenterology had the highest prevalence of FCOI compared with other medical specialties. Among the 8 studies that included the monetary values in US dollars of FCOI, average payments per author ranged from $578 to $242,300. Among the 10 studies that included data on undisclosed FCOI, 32% of authors had undisclosed industry payments.
CONCLUSION
There are numerous FCOI among authors of CPGs, many of which are undisclosed Our study found a significant difference in FCOI prevalence based on types of FCOI and CPG sponsor society. Additional research is required to quantify the implications of FCOI on clinical judgment and patient care.
PubMed: 33997642
DOI: 10.1016/j.mayocpiqo.2020.09.016 -
Clinical Journal of the American... Dec 2020Patients with kidney failure experience depression at rates higher than the general population. Despite the Centers for Medicare and Medicaid Services' ESRD Quality...
BACKGROUND AND OBJECTIVES
Patients with kidney failure experience depression at rates higher than the general population. Despite the Centers for Medicare and Medicaid Services' ESRD Quality Incentive Program requirements for routine depression screening for patients with kidney failure, no clear guidance exists.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS
For this systematic review, we searched MEDLINE, PsycINFO, and other databases from inception to June 2020. Two investigators screened all abstracts and full text. We included studies assessing patients with kidney failure and compared a tool to a clinical interview or another validated tool (., Beck Depression Inventory II). We abstracted data related to sensitivity and specificity, positive and negative predictive value, and the area under the curve. We evaluated the risk of bias using the Quality Assessment of Diagnostic Accuracy Studies 2.
RESULTS
A total of 16 studies evaluated the performance characteristics of depression assessment tools for patients with kidney failure. The Beck Depression Inventory II was by far the best studied. A wide range of thresholds were reported. Shorter tools in the public domain such as the Patient Health Questionnaire 9 and Geriatric Depression Scale 15 (adults over 60) performed well but were not well studied. Short tools such as the Beck Depression Inventory-Fast Screen may be a good option for an initial screen.
CONCLUSIONS
There is limited research evaluating the diagnostic accuracy of most screening tools for depression in patients with kidney failure, and existing studies may not be generalizable to US populations. Studies suffer from limitations related to methodology quality and/or reporting. Future research should target widely used, free tools such as the Patient Health Questionnaire 2 and the Patient Health Questionnaire 9.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER
Systematic Review Registration: PROSPERO CRD42020140227.
Topics: Aged; Depression; Diagnostic Screening Programs; Geriatric Assessment; Humans; Middle Aged; Patient Health Questionnaire; Predictive Value of Tests; Prognosis; Renal Insufficiency; Renal Replacement Therapy; Risk Assessment; Risk Factors
PubMed: 33203736
DOI: 10.2215/CJN.05540420 -
Journal of Vascular Surgery Jan 2024To identify disparities in sociodemographic factors that are associated with major lower limb amputation in patients with peripheral arterial disease (PAD). (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To identify disparities in sociodemographic factors that are associated with major lower limb amputation in patients with peripheral arterial disease (PAD).
METHODS
A systematic review of the literature was performed to identify studies that reported major lower limb amputation rates in patients with PAD among different sociodemographic groups. Data that compared amputation rates on the basis of sex, race, ethnicity, income, insurance, geography, and hospital type were collected and described. Outcomes were then aggregated and standardized, and a meta-analysis was performed to synthesis data into single odds ratios (ORs).
RESULTS
Forty-one studies were included in the review. There was no association found between males and females (OR, 0.95; 95% confidence interval [CI], 0.90-1.00). Compared with Whites, higher rates of amputation were seen among Blacks/African Americans (OR, 2.02; 95% CI, 1.81-2.26) and Native Americans (OR, 1.22; 95% CI, 1.04-1.45). No significant association was found between Whites and Asians, Native Hawaiians, or Pacific Islanders (OR, 1.15; 95% CI, 1.00-1.33). Hispanics had higher rates of amputation compared with non-Hispanics (OR, 1.36; 95% CI, 1.22-1.52). Compared with private insurance, higher rates of amputation were seen among Medicare patients (OR, 1.38; 95% CI, 1.27-1.50), Medicaid patients (OR, 1.59; 95% CI, 1.44-1.76), and noninsured patients (OR, 1.41; 95% CI, 1.02-1.95). Compared with the richest income quartile, higher rates of amputation were seen among the second income quartile (OR, 1.10; 95% CI, 1.05-1.15), third income quartile (OR, 1.20; 95% CI, 1.07-1.35), and bottom income quartile (OR, 1.36; 95% CI, 1.24-1.49). There was no association found between rural and urban populations (OR, 1.35; 95% CI, 0.92-1.97) or between teaching and nonteaching hospitals (OR, 1.01; 95% CI, 0.91-1.12).
CONCLUSIONS
Our study has identified a number of disparities and quantified the influence of sociodemographic factors on major lower limb amputation rates owing to PAD between groups. We believe these findings can be used to better target interventions aimed at decreasing amputation rates, although further research is needed to better understand the mechanisms behind our findings.
Topics: Aged; Female; Humans; Male; Amputation, Surgical; Medicare; Peripheral Arterial Disease; Retrospective Studies; Risk Factors; Sociodemographic Factors; Treatment Outcome; United States
PubMed: 37722513
DOI: 10.1016/j.jvs.2023.08.130 -
JACC. Cardiovascular Interventions Apr 2022Transcatheter aortic valve replacement (TAVR) is the standard of care for severe, symptomatic aortic stenosis. Real-world TAVR data collection contributes to...
Transcatheter aortic valve replacement (TAVR) is the standard of care for severe, symptomatic aortic stenosis. Real-world TAVR data collection contributes to benefit/risk assessment and safety evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, as well as clinical research and real-world implementation through appropriate use criteria. The essential minimum core dataset for these purposes has not previously been defined but is necessary to promote efficient, reusable real-world data collection supporting quality, regulatory, and clinical applications. The authors performed a systematic review of the published research for high-impact TAVR studies and U.S. multicenter, multidevice registries. Two expert task forces, one from the Predictable and Sustainable Implementation of National Cardiovascular Registries/Heart Valve Collaboratory and another from The Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry convened separately and then met to reconcile a final list of essential data elements. From 276 unique data elements considered, unanimous consensus agreement was achieved on 132 "core" data elements, with the most common reasons for exclusion from the minimum core dataset being burden or difficulty in accurate assessment (36.9%), duplicative information (33.3%), and low likelihood of affecting outcomes (10.7%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established 132 interoperable, reusable essential core data elements essential to supporting more efficient, consistent, and informative TAVR device evidence for regulatory submissions, safety surveillance, best practice, and hospital quality assessments.
Topics: Aged; Aortic Valve; Aortic Valve Stenosis; Humans; Medicare; Multicenter Studies as Topic; Registries; Risk Factors; Time Factors; Transcatheter Aortic Valve Replacement; Treatment Outcome; United States
PubMed: 35367168
DOI: 10.1016/j.jcin.2022.01.014 -
JAMA Network Open Jul 2020Health care spending in the United States continues to grow. Mental health and substance use disorders (MH/SUDs) are prevalent and associated with worse health outcomes...
IMPORTANCE
Health care spending in the United States continues to grow. Mental health and substance use disorders (MH/SUDs) are prevalent and associated with worse health outcomes and higher health care spending; alternative payment and delivery models (APMs) have the potential to facilitate higher quality, integrated, and more cost-effective MH/SUD care.
OBJECTIVE
To systematically review and summarize the published literature on populations and MH/SUD conditions examined by APM evaluations and the associations of APMs with MH/SUD outcomes.
EVIDENCE REVIEW
A literature search of MEDLINE, PsychInfo, Scopus, and Business Source was conducted from January 1, 1997, to May 17, 2019, for publications examining APMs for MH/SUD services, assessing at least 1 MH/SUD outcome, and having a comparison group. A total of 27 articles met these criteria, and each was classified according to the Health Care Payment Learning and Action Network's APM framework. Strength of evidence was graded using a modified Oxford Centre for Evidence-Based Medicine framework.
FINDINGS
The 27 included articles evaluated 17 APM implementations that spanned 3 Health Care Payment Learning and Action Network categories and 6 subcategories, with no single category predominating the literature. APMs varied with regard to their assessed outcomes, funding sources, target populations, and diagnostic focuses. The APMs were primarily evaluated on their associations with process-of-care measures (15 [88.2%]), followed by utilization (11 [64.7%]), spending (9 [52.9%]), and clinical outcomes (5 [29.4%]). Medicaid and publicly funded SUD programs were most common, with each representing 7 APMs (41.2%). Most APMs focused on adults (11 [64.7%]), while fewer (2 [11.8%]) targeted children or adolescents. More than half of the APMs (9 [52.9%]) targeted populations with SUD, while 4 (23.5%) targeted MH populations, and the rest targeted MH/SUD broadly defined. APMs were most commonly associated with improvements in MH/SUD process-of-care outcomes (12 of 15 [80.0%]), although they were also associated with lower spending (4 of 8 [50.0%]) and utilization (5 of 11 [45.5%]) outcomes, suggesting gains in value from APMs. However, clinical outcomes were rarely measured (5 APMs [29.4%]). A total of 8 APMs (47.1%) assessed for gaming (ie, falsification of outcomes because of APM incentives) and adverse selection, with 1 (12.5%) showing evidence of gaming and 3 (37.5%) showing evidence of adverse selection. Other than those assessing accountable care organizations, few studies included qualitative evaluations.
CONCLUSIONS AND RELEVANCE
In this study, APMs were associated with improvements in process-of-care outcomes, reductions in MH/SUD utilization, and decreases in spending. However, these findings cannot fully substitute for assessments of clinical outcomes, which have rarely been evaluated in this context. Additionally, this systematic review identified some noteworthy evidence for gaming and adverse selection, although these outcomes have not always been duly measured or analyzed. Future research is needed to better understand the varied qualitative experiences across APMs, their successful components, and their associations with clinical outcomes among diverse populations and settings.
Topics: Accountable Care Organizations; Health Expenditures; Humans; Mental Health; Patient Acceptance of Health Care; Quality Improvement; Substance-Related Disorders; United States
PubMed: 32701157
DOI: 10.1001/jamanetworkopen.2020.7401 -
Otolaryngology--head and Neck Surgery :... Jun 2024Initiating postoperative radiotherapy (PORT) within 6 weeks of surgery for head and neck squamous cell carcinoma (HNSCC) is included in the National Comprehensive Cancer... (Review)
Review
OBJECTIVE
Initiating postoperative radiotherapy (PORT) within 6 weeks of surgery for head and neck squamous cell carcinoma (HNSCC) is included in the National Comprehensive Cancer Network Clincal Practice Guidelines and is a Commission on Cancer quality metric. Factors associated with delays in starting PORT have not been systematically described nor synthesized.
DATA SOURCES
PubMed, Scopus, and CINAHL.
REVIEW METHODS
We included studies describing demographic characteristics, clinical factors, or social determinants of health associated with PORT delay (>6 weeks) in patients with HNSCC treated in the United States after 2003. Meta-analysis of odds ratios (ORs) was performed on nonoverlapping datasets.
RESULTS
Of 716 unique abstracts reviewed, 21 studies were included in the systematic review and 15 in the meta-analysis. Study sample size ranged from 19 to 60,776 patients. In the meta-analysis, factors associated with PORT delay included black race (OR, 1.46, 95% confidence interval [CI]: 1.28-1.67), Hispanic ethnicity (OR, 1.37, 95% CI, 1.17-1.60), Medicaid or no health insurance (OR, 2.01, 95% CI, 1.90-2.13), lower income (OR, 1.38, 95% CI, 1.20-1.59), postoperative admission >7 days (OR, 2.92, 95% CI, 2.31-3.67), and 30-day hospital readmission (OR, 1.37, 95% CI, 1.29-1.47).
CONCLUSION
Patients at greatest risk for a delay in initiating guideline-adherent PORT include those who are from minoritized communities, of lower socioeconomic status, and experience postoperative challenges. These findings provide the foundational evidence needed to deliver targeted interventions to enhance equity and quality in HNSCC care delivery.
PubMed: 38842034
DOI: 10.1002/ohn.835 -
Surgical Endoscopy May 2023Some studies have suggested disparities in access to robotic colorectal surgery, however, it is unclear which factors are most meaningful in the determination of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Some studies have suggested disparities in access to robotic colorectal surgery, however, it is unclear which factors are most meaningful in the determination of approach relative to laparoscopic or open surgery. This study aimed to identify the most influential factors contributing to robotic colorectal surgery utilization.
METHODS
We conducted a systematic review and random-effects meta-analysis of published studies that compared the utilization of robotic colorectal surgery versus laparoscopic or open surgery. Eligible studies were identified through PubMed, EMBASE, CINAHL, Cochrane CENTRAL, PsycINFO, and ProQuest Dissertations in September 2021.
RESULTS
Twenty-nine studies were included in the analysis. Patients were less likely to undergo robotic versus laparoscopic surgery if they were female (OR = 0.91, 0.84-0.98), older (OR = 1.61, 1.38-1.88), had Medicare (OR = 0.84, 0.71-0.99), or had comorbidities (OR = 0.83, 0.77-0.91). Non-academic hospitals had lower odds of conducting robotic versus laparoscopic surgery (OR = 0.73, 0.62-0.86). Additional disparities were observed when comparing robotic with open surgery for patients who were Black (OR = 0.78, 0.71-0.86), had lower income (OR = 0.67, 0.62-0.74), had Medicaid (OR = 0.58, 0.43-0.80), or were uninsured (OR = 0.29, 0.21-0.39).
CONCLUSION
When determining who undergoes robotic surgery, consideration of factors such as age and comorbid conditions may be clinically justified, while other factors seem less justifiable. Black patients and the underinsured were less likely to undergo robotic surgery. This study identifies nonclinical disparities in access to robotics that should be addressed to provide more equitable access to innovations in colorectal surgery.
Topics: Humans; Female; Aged; United States; Male; Robotic Surgical Procedures; Colorectal Surgery; Medicare; Robotics; Digestive System Surgical Procedures; Laparoscopy
PubMed: 36520224
DOI: 10.1007/s00464-022-09793-8 -
Journal of Evaluation in Clinical... Aug 2021Missed appointments are a persistent problem across healthcare settings, and result in negative outcomes for providers and patients. We aimed to review and evaluate the... (Meta-Analysis)
Meta-Analysis Review
RATIONALE, AIMS AND OBJECTIVES
Missed appointments are a persistent problem across healthcare settings, and result in negative outcomes for providers and patients. We aimed to review and evaluate the effectiveness of interventions designed to reduce missed appointments in safety net settings.
METHODS
We conducted a systematic review of interventions reported in three electronic databases. Data extraction and quality assessment were conducted according to PRISMA guidelines. Eligible studies were analyzed qualitatively to describe intervention types. A random effects model was used to measure the pooled relative risk of appointment adherence across interventions in the meta-analysis.
RESULTS
Thirty-four studies met inclusion criteria for the qualitative synthesis, and 21 studies reported sufficient outcome data for inclusion in the meta-analysis. Qualitative analysis classified nine types of interventions used to increase attendance; however, application of each intervention type varied widely between studies. Across all study types (N = 12 000), RR was 1.08, (95% CI 1.03, 1.13) for any intervention used to increase appointment attendance. No single intervention was clearly effective: facilitated appointment scheduling [RR = 3.31 (95% CI: 0.30, 37.13)], financial incentives [RR = 1.88 (0.73, 4.82)] case management/patient navigator [RR = 1.09, (0.96, 1.24)], text messages [RR = 1.02 (0.96, 1.08)], transportation, [RR = 1.05 (0.98, 1.13)], telephone reminder calls [RR 1.12, (0.87, 1.45)], in-person referrals, [RR = 1.01 (0.90, 1.13)], patient contracts [RR = 0.87 (0.52, 1.46)] or combined strategies, [RR = 1.16 (1.03, 1.32)]. No strategy was clearly superior to others, p interaction = .50.
CONCLUSIONS
Strategies to improve appointment adherence in safety net hospitals varied widely and were only modestly effective. Further research harmonizing intervention delivery within each strategy and comparing strategies with the most potential for success is needed.
Topics: Appointments and Schedules; Humans; Reminder Systems; Text Messaging
PubMed: 33064929
DOI: 10.1111/jep.13496 -
The Journal of Trauma and Acute Care... Aug 2019Trauma and emergency general surgery (EGS) patients who are uninsured have worse outcomes as compared with insured patients. Partially modeled after the 2006... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Trauma and emergency general surgery (EGS) patients who are uninsured have worse outcomes as compared with insured patients. Partially modeled after the 2006 Massachusetts Healthcare Reform (MHR), the Patient Protection and Affordable Care Act was passed in 2010 with the goal of expanding health insurance coverage, primarily through state-based Medicaid expansion (ME). We evaluated the impact of ME and MHR on outcomes for trauma patients, EGS patients, and trauma systems.
METHODS
This study was approved by the Eastern Association for the Surgery of Trauma Guidelines Committee. Using Grading of Recommendations Assessment, Development and Evaluation methodology, we defined three populations of interest (trauma patients, EGS patients, and trauma systems) and identified the critical outcomes (mortality, access to care, change in insurance status, reimbursement, funding). We performed a systematic review of the literature. Random effect meta-analyses and meta-regression analyses were calculated for outcomes with sufficient data.
RESULTS
From 4,593 citations, we found 18 studies addressing all seven predefined outcomes of interest for trauma patients, three studies addressing six of seven outcomes for EGS patients, and three studies addressing three of eight outcomes for trauma systems. On meta-analysis, trauma patients were less likely to be uninsured after ME or MHR (odds ratio, 0.49; 95% confidence interval, 0.37-0.66). These coverage expansion policies were not associated with a change in the odds of inpatient mortality for trauma (odds ratio, 0.96; 95% confidence interval, 0.88-1.05). Emergency general surgery patients also experienced a significant insurance coverage gains and no change in inpatient mortality. Insurance expansion was often associated with increased access to postacute care at discharge. The evidence for trauma systems was heterogeneous.
CONCLUSION
Given the evidence quality, we conditionally recommend ME/MHR to improve insurance coverage and access to postacute care for trauma and EGS patients. We have no specific recommendation with respect to the impact of ME/MHR on trauma systems. Additional research into these questions is needed.
LEVEL OF EVIDENCE
Review, Economic/Decision, level III.
Topics: Emergencies; Humans; Insurance Coverage; Patient Protection and Affordable Care Act; Surgical Procedures, Operative; Traumatology; Treatment Outcome; United States; Wounds and Injuries
PubMed: 31095067
DOI: 10.1097/TA.0000000000002368