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Stem Cell Investigation 2021Hematopoietic stem cell transplant (HSCT) is an expensive and complex treatment regimen that can be curative in many diseases of the bone marrow, including malignant and... (Review)
Review
BACKGROUND
Hematopoietic stem cell transplant (HSCT) is an expensive and complex treatment regimen that can be curative in many diseases of the bone marrow, including malignant and non-malignant conditions. The introduction of the Affordable Care Act increased access to potential candidates and removed or reduced many barriers previously identified in the literature, however, racial disparities continue to persist. As HSCT expands its utilization and indications, there is a continued need to understand the multifactorial barriers which lead to inequalities in transplant referral, utilization, and survival. The objective of this systematic review is to summarize these racial disparities, expand the current understanding of the literature, and determine whether the increases in insurance status from Medicaid expansion have played a role in HSCT utilization and survival rates by race.
METHODS
We explored studies based on retrospective reviews, literature reviews, and focus groups with the key-terms of 'race', 'hematopoietic stem cell transplant', and 'disparities'. The included studies were extracted from Cochrane and Medline databases. After screening for relevancy to research aims and objectives, 10 articles were utilized for background information and discussion, while 30 articles were categorized into main groups of outcomes, chiefly, (I) access/referral to transplant and (II) survival.
RESULTS
Eight of the eleven retrospective reviews found substantial variation in access to HSCT by ethnic minorities (Black, Hispanic, or Asian) when compared to their Caucasian counterparts. Thirteen of the fourteen publications found racial disparities in either overall survival, progression free survival, treatment related mortality, relapse, or combinations of these outcomes. The majority of the studies evaluated African American patients with six of eight studies showing significantly elevated mortality compared to Caucasian patients.
DISCUSSION
Substantial variation exists in access to HSCT, particularly in black patients. Having less generous insurance coverage was previously hypothesized to reduce the likelihood of HSCT utilization. Studies performed after full implementation of the Affordable Care Act continue to show poorer survival among ethnic minorities, particularly black patients, despite this increased coverage. Perceived racial bias and health-related stigma, as well as physician decisions and delay in referral process are likely contributing factors.
PubMed: 35071585
DOI: 10.21037/sci-2021-058 -
Journal of Managed Care & Specialty... Jan 2022Benzodiazepines are indicated for the treatment of many conditions, such as anxiety disorders, muscle spasms, alcohol withdrawal, agitation, movement disorders, and...
Benzodiazepines are indicated for the treatment of many conditions, such as anxiety disorders, muscle spasms, alcohol withdrawal, agitation, movement disorders, and epilepsy, and are one of the most frequently prescribed medication classes. This class of medication has important safety considerations, including an increased risk of dependence and addiction, falls, and death from opioid overdose. Although benzodiazepine safety and prescribing encompasses a rich and important research area, there is a lack of pharmacoepidemiologic literature addressing benzodiazepine dosing intensity in real-world settings. To develop and apply a standardized benzodiazepine milligram equivalency conversion algorithm and assess the dose intensity of benzodiazepine use in Rhode Island (RI) in 2018. A systematic literature review was conducted to identify the most commonly used benzodiazepine equivalency values. We then conducted a cross-sectional analysis of 2018 data from the RI Prescription Drug Monitoring Program (PDMP) to calculate the mean daily diazepam milligram equivalency (DME) based on a patient's most recent dispensing. A multivariable logistic regression analysis was conducted to determine the association between higher benzodiazepine doses (≥ 15 DME/day) and recipient characteristics, including concurrent use of opioids or stimulants. We identified 143,026 patients who received at least 1 prescription for a benzodiazepine in RI in 2018. The mean (SD) daily DME was 10.60 (9.05), and 26.2% of individuals had a mean DME per day of at least 15. Approximately 14% (n = 20,168) of patients prescribed a benzodiazepine had concurrent use with a prescription opioid, and 6.7% (n = 9,547) had concurrent use with a prescription stimulant. Females had a 28% lower adjusted odds of receiving a benzodiazepine dose of at least 15 DME per day compared with males (adjusted odds ratio [aOR] = 0.72, 95% CI = 0.70-0.73). The adjusted odds of receiving a benzodiazepine prescription of at least 15 DME per day was lower among the younger (aged 18-34 years) and older age groups (aged 65 years and older) compared with patients aged 35-64 years. Compared with commercial insurance, all other forms of payment had significantly higher adjusted odds of a daily benzodiazepine dose of at least 15 DME per day. The adjusted odds receiving a daily DME of at least 15 was 67% higher among those who also received a concurrent pharmacy dispensing for an opioid and 84% higher among those who also received a concurrent dispensing for a stimulant drug (aOR = 1.67, 95% CI = 1.61-1.72; aOR = 1.84, 95% CI = 1.76-1.93, respectively). Individuals aged 35-64 years with Medicaid insurance and those aged under 65 years with Medicare were more likely to be prescribed a benzodiazepine of at least 15 DME per day. Higher benzodiazepine DMEs were also dispensed to patients who concurrently used prescription opioids or stimulants who may be at increased risk of medication-related harm. We advocate for routine measurement of benzodiazepine dose intensity as a risk reduction strategy. No funding supported this study. The authors have no conflicts of interest to disclose. The content and results of this study are solely the responsibility of the authors and do not necessarily represent the official views of the Rhode Island Department of Health. Kogut is partially supported by Institutional Development Award Numbers U54GM115677 and P20GM125507 from the National Institute of General Medical Sciences of the National Institutes of Health, which funds Advance Clinical and Translational Research (Advance-CTR) and the RI Lifespan Center of Biomedical Research Excellence (COBRE) on Opioids and Overdose, respectively. The content of this study is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Contents of this study were presented as a poster presentation at AMCP 2019 Nexus; October 29-November 1, 2019; National Harbor, MD.
Topics: Adolescent; Adult; Algorithms; Benzodiazepines; Cross-Sectional Studies; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Logistic Models; Male; Middle Aged; Rhode Island; Young Adult
PubMed: 34949119
DOI: 10.18553/jmcp.2022.28.1.58 -
Journal of Immigrant and Minority Health Jun 2022Sexual, reproductive, and maternal health (SRMH) care in the US is highly politicized, with restrictions that impede immigrant women's health. This review describes SRMH... (Review)
Review
Sexual, reproductive, and maternal health (SRMH) care in the US is highly politicized, with restrictions that impede immigrant women's health. This review describes SRMH outcomes among immigrant women accessing publicly-funded services. We examined articles published from December 2007 to August 2020 in PubMed, PsycINFO, and Web of Science databases, following PRISMA guidelines. Included articles (n = 9) consisted of predominantly Latina immigrant samples. The majority included a subsample of women classified as vulnerable due to low income, low educational attainment, and/or documentation status. Our search strategy included a range of SRMH outcomes; however, the majority of articles focused on prenatal care (PNC). Over half of the articles revealed that underserved immigrant women with access to Medicaid/CHIP during expansion had higher rates of PNC adequacy compared to those without access. There is a need for more research on the impact of publicly-funded services other than Medicaid on outcomes beyond PNC.
Topics: Emigrants and Immigrants; Female; Health Services Accessibility; Humans; Maternal Health Services; Medicaid; Pregnancy; Prenatal Care; United States
PubMed: 34697702
DOI: 10.1007/s10903-021-01289-2 -
Surgery Feb 2022The goal of this study was an assessment of availability postoperative pain management quality measures and National Quality Forum-endorsed measures. Postoperative pain...
BACKGROUND
The goal of this study was an assessment of availability postoperative pain management quality measures and National Quality Forum-endorsed measures. Postoperative pain is an important clinical timepoint because poor pain control can lead to patient suffering, chronic opiate use, and/or chronic pain. Quality measures can guide best practices, but it is unclear whether there are measures for managing pain after surgery.
METHODS
The National Quality Forum Quality Positioning System, Agency for Healthcare Research and Quality Indicators, and Centers for Medicare and Medicaid Services Measures Inventory Tool databases were searched in November 2019. We conducted a systematic literature review to further identify quality measures in research publications, clinical practice guidelines, and gray literature for the period between March 11, 2015 and March 11, 2020.
RESULTS
Our systematic review yielded 1,328 publications, of which 206 were pertinent. Nineteen pain management quality measures were identified from the quality measure databases, and 5 were endorsed by National Quality Forum. The National Quality Forum measures were not specific to postoperative pain management. Three of the non-endorsed measures were specific to postoperative pain.
CONCLUSION
The dearth of published postoperative pain management quality measures, especially National Quality Forum-endorsed measures, highlights the need for more rigorous evidence and widely endorsed postoperative pain quality measures to guide best practices.
Topics: Centers for Medicare and Medicaid Services, U.S.; Databases, Factual; Humans; Medicare; Pain Management; Pain, Postoperative; Practice Guidelines as Topic; Practice Patterns, Physicians'; Professional Practice Gaps; United States; United States Agency for Healthcare Research and Quality
PubMed: 34538340
DOI: 10.1016/j.surg.2021.08.004 -
NPJ Digital Medicine Jul 2021Mobile health (mHealth) technologies improve hypertension outcomes, but it is unknown if this benefit applies to all populations. This review aimed to describe the... (Review)
Review
Mobile health (mHealth) technologies improve hypertension outcomes, but it is unknown if this benefit applies to all populations. This review aimed to describe the impact of mHealth interventions on blood pressure outcomes in populations with disparities in digital health use. We conducted a systematic search to identify studies with systolic blood pressure (SBP) outcomes located in urban settings in high-income countries that included a digital health disparity population, defined as mean age ≥65 years; lower educational attainment (≥60% ≤high school education); and/or racial/ethnic minority (<50% non-Hispanic White for US studies). Interventions were categorized using an established self-management taxonomy. We conducted a narrative synthesis; among randomized clinical trials (RCTs) with a six-month SBP outcome, we conducted random-effects meta-analyses. Twenty-nine articles (representing 25 studies) were included, of which 15 were RCTs. Fifteen studies used text messaging; twelve used mobile applications. Studies were included based on race/ethnicity (14), education (10), and/or age (6). Common intervention components were: lifestyle advice (20); provision of self-monitoring equipment (17); and training on digital device use (15). In the meta-analyses of seven RCTs, SBP reduction at 6-months in the intervention group (mean SBP difference = -4.10, 95% CI: [-6.38, -1.83]) was significant, but there was no significant difference in SBP change between the intervention and control groups (p = 0.48). The use of mHealth tools has shown promise for chronic disease management but few studies have included older, limited educational attainment, or minority populations. Additional robust studies with these populations are needed to determine what interventions work best for diverse hypertensive patients.
PubMed: 34294852
DOI: 10.1038/s41746-021-00486-5 -
JMIR Rehabilitation and Assistive... Jun 2021The term 'Telemedicine' was coined in the 1970s to imply 'healing at a distance. Physical therapy rehabilitation (PTR) focuses on the re-institution of function in...
BACKGROUND
The term 'Telemedicine' was coined in the 1970s to imply 'healing at a distance. Physical therapy rehabilitation (PTR) focuses on the re-institution of function in bodily strength and movement. Covid-19 has created a challenge in one-on-one PTR sessions due to social distancing, which requires the minimization of all non-essential physical contact. Most outpatient services in PTR have had to be staggered and minimized to increase adherence to social distancing requirements and flatten the pandemic's curve. Telemedicine is applicable in PTR in several ways, including guided therapy sessions, and remote monitoring of patient progress through videoconferencing. Telemedicine allows patients to access PTR from the comfort of their homes, which minimizes travel costs and general strain on the body. Although it has been encumbered by various challenges, telemedicine could revolutionize the delivery of PTR while also increasing access to essential healthcare services.
OBJECTIVE
Purpose: Covering the main aspects of telemedicine usability in physical therapy rehabilitation, that encourage using of the telemedicine in physical therapy in the world regions not covered by, especially the Middle East.
METHODS
Method: A systematic search in libgen.is, jmir.org, wiley.com, sagepub.com, and scholar.google.com. was performed using the search terms: Telemedicine; asynchronous telemedicine; synchronous telemedicine; Covid-19; rehabilitation medicine; physical therapy rehabilitation; videoconferencing; Medicaid programs; telehealth; and HIPAA. Papers published up to Oct. 22nd, 2020, in English, were included.
RESULTS
Telemedicine is cost-effective for physical therapy Rehabilitation particularly in pandemic like COVID19, also it's time and human resources saving especially with hands-off skills rehabilitation.
CONCLUSIONS
Telemedicine is a revolutionary aspect of medicine that has seen an unexpected uptake following the Covid-19 pandemic. While people formerly preferred live sessions for PTR, the convenience of telemedicine is increasingly emerging. The various advantages, including reduced cost implications, reduced waiting time, and reduction of non-essential travel to obtain therapy have increased the preference for telemedicine. [9] The WHO recognizes the importance of Telemedicine, and conducted a regional and global survey to analyze its viability. At the onset of global lockdown due to Covid-19, the APTA expressed the need for physiotherapists to utilize telemedicine as an alternative for efficient PTR delivery within the bounds of social recommendations for curve-flattening. Telemedicine in PTR has various advantages including cost reduction, the convenience of access, reduction of long waiting lists among others for the patient. [10] PTR can also be availed to areas that are too remote to have a full-fledged PTR center. Through the utilization of nurse aides and other social support systems, therapists can effectively conduct therapy sessions through videoconferencing. Laws governing the adoption and use of telemedicine for PTR include the HIPAA and other DPL, which regulate the extent to which therapists can collect, use, and store data collected during online therapy sessions. Therapists need to obtain verifiable consent from the patient before commencement.
PubMed: 34287208
DOI: 10.2196/25250 -
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 -
JAMA Network Open May 2021Chiral switching, a strategy in which drug manufacturers develop a single-enantiomer formulation of a drug to be substituted for a racemic formulation, allows...
IMPORTANCE
Chiral switching, a strategy in which drug manufacturers develop a single-enantiomer formulation of a drug to be substituted for a racemic formulation, allows manufacturers to maintain market exclusivity for drugs losing patent protection, even without demonstrating superior efficacy or safety.
OBJECTIVE
To identify and characterize all randomized clinical trials (RCTs) directly comparing a Food and Drug Administration (FDA)-approved single-enantiomer drug against a previously approved racemic drug for 1 or more efficacy or safety end points.
EVIDENCE REVIEW
Drugs were identified using the Drugs@FDA database. Randomized clinical trials were identified using Ovid MEDLINE (1949 to October 22, 2019), Ovid Embase (1974 to October 22, 2019), Web of Science Core Collection (all years), ClinicalTrials.gov, and Cochrane Central Registry of Controlled Trials (CENTRAL, Wiley, Issue 8 of 12, October 22, 2019). Trials were characterized as favoring the single-enantiomer or racemic drugs based on whether the primary efficacy, secondary efficacy, and safety end points achieved each study's defined significance level (eg, P < .05). Trials were characterized as favoring neither drug if no statistically significant differences were reported for any end point or if both drugs were found to be superior for 1 or more separate end points.
FINDINGS
Fifteen FDA-approved single-enantiomer drugs were identified with racemic precursors approved in the US or Europe. For 3 single-enantiomer racemic drug pairs, no RCTs directly comparing the drugs were identified. For the remaining 12 pairs, 185 RCTs comparing efficacy or safety of the drug pairs were identified, 124 (67.0%) of which studied 1 pair (levobupivacaine/bupivacaine). There were 179 RCTs directly comparing drug pairs using efficacy end points, of which 23 (12.8%) favored the single enantiomer based on primary efficacy end point results. There were 124 RCTs directly comparing drug pairs using safety end points, of which 17 (13.7%) favored the single-enantiomer drug. For 9 of the 15 single-enantiomer drugs (60.0%), no RCTs were identified providing evidence of improved efficacy, based on primary end point results, or safety as compared with their racemic precursors.
CONCLUSIONS AND RELEVANCE
The results of this systematic review suggest that most newly marketed FDA-approved single-enantiomer drugs are infrequently directly compared with their racemic precursors, and when compared, they are uncommonly found to provide improved efficacy or safety, despite their greater costs.
Topics: Drug Approval; Drug Compounding; Drug Prescriptions; Drugs, Generic; Humans; Medicare; Randomized Controlled Trials as Topic; Stereoisomerism; United States
PubMed: 33956134
DOI: 10.1001/jamanetworkopen.2021.5731 -
Clinical Orthopaedics and Related... Nov 2021The goal of bundled payments-lump monetary sums designed to cover the full set of services needed to provide care for a condition or medical event-is to provide a...
BACKGROUND
The goal of bundled payments-lump monetary sums designed to cover the full set of services needed to provide care for a condition or medical event-is to provide a reimbursement structure that incentivizes improved value for patients. There is concern that such a payment mechanism may lead to patient screening and denying or providing orthopaedic care to patients based on the number and severity of comorbid conditions present associated with complications after surgery. Currently, however, there is no clear consensus about whether such an association exists.
QUESTIONS/PURPOSES
In this systematic review, we asked: (1) Is the implementation of a bundled payment model associated with a change in the sociodemographic characteristics of patients undergoing an orthopaedic procedure? (2) Is the implementation of a bundled payment model associated with a change in the comorbidities and/or case-complexity characteristics of patients undergoing an orthopaedic procedure? (3) Is the implementation of a bundled payment model associated with a change in the recent use of healthcare resources characteristics of patients undergoing an orthopaedic procedure?
METHODS
This systematic review was registered in PROSPERO before data collection (CRD42020189416). Our systematic review included scientific manuscripts published in MEDLINE, Embase, Web of Science, Econlit, Policyfile, and Google Scholar through March 2020. Of the 30 studies undergoing full-text review, 20 were excluded because they did not evaluate the outcome of interest (patient selection) (n = 8); were editorial, commentary, or review articles (n = 5); did not evaluate the appropriate intervention (introduction of a bundled payment program) (n = 4); or assessed the wrong patient population (not orthopaedic surgery patients) (n = 3). This led to 10 studies included in this systematic review. For each study, patient factors analyzed in the included studies were grouped into the following three categories: sociodemographics, comorbidities and/or case complexity, or recent use of healthcare resources characteristics. Next, each patient factor falling into one of these three categories was examined to evaluate for changes from before to after implementation of a bundled payment initiative. In most cases, studies utilized a difference-in-difference (DID) statistical technique to assess for changes. Determination of whether the bundled payment initiative required mandatory participation or not was also noted. Scientific quality using the Adapted Newcastle-Ottawa Scale had a median (range) score of 8 (7 to 8; highest possible score: 9), and the quality of the total body of evidence for each patient characteristic group was found to be low using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) tool. We could not assess the likelihood of publication using funnel plots because of the variation of patient factors analyzed in each study and the heterogeneity of data precluded a meta-analysis.
RESULTS
Of the nine included studies that reported on the sociodemographic characteristics of patients selected for care, seven showed no change with the implementation of bundled payments, and two demonstrated a difference. Most notably, the studies identified a decrease in the percentage of patients undergoing an orthopaedic operative intervention who were dual-eligible (range DID estimate -0.4% [95% CI -0.75% to -0.1%]; p < 0.05 to DID estimate -1.0% [95% CI -1.7% to -0.2%]; p = 0.01), which means they qualified for both Medicare and Medicaid insurance coverage. Of the 10 included studies that reported on comorbidities and case-complexity characteristics, six reported no change in such characteristics with the implementation of bundled payments, and four studies noted differences. Most notably, one study showed a decrease in the number of treated patients with disabilities (DID estimate -0.6% [95% CI -0.97% to -0.18%]; p < 0.05) compared with before bundled payment implementation, while another demonstrated a lower number of Elixhauser comorbidities for those treated as part of a bundled payment program (before: score of 0-1 in 63.6%, 2-3 in 27.9%, > 3 in 8.5% versus after: score of 0-1 in 50.1%, 2-3 in 38.7%, > 3 in 11.2%; p = 0.033). Of the three included studies that reported on the recent use of healthcare resources of patients, one study found no difference in the use of healthcare resources with the implementation of bundled payments, and two studies did find differences. Both studies found a decrease in patients undergoing operative management who recently received care at a skilled nursing facility (range DID estimate -0.50% [95% CI -1.0% to 0.0%]; p = 0.04 to DID estimate: -0.53% [95% CI -0.96% to -0.10%]; p = 0.01), while one of the studies also found a decrease in patients undergoing operative management who recently received care at an acute care hospital (DID estimate -0.8% [95% CI -1.6% to -0.1%]; p = 0.03) or as part of home healthcare (DID estimate -1.3% [95% CI -2.0% to -0.6%]; p < 0.001).
CONCLUSION
In six of 10 studies in which differences in patient characteristics were detected among those undergoing operative orthopaedic intervention once a bundled payment program was initiated, the effect was found to be minimal (approximately 1% or less). However, our findings still suggest some level of adverse patient selection, potentially worsening health inequities when considered on a large scale. It is also possible that our findings reflect better care, whereby the financial incentives lead to fewer patients with a high risk of complications undergoing surgical intervention and vice versa for patients with a low risk of complications postoperatively. However, this is a fine line, and it may also be that patients with a high risk of complications postoperatively are not being offered surgery enough, while patients at low risk of complications postoperatively are being offered surgery too frequently. Evaluation of the longer-term effect of these preliminary bundled payment programs on patient selection is warranted to determine whether adverse patient selection changes over time as health systems and orthopaedic surgeons become accustomed to such reimbursement models.
Topics: Humans; Orthopedic Procedures; Orthopedics; Patient Care Bundles; Reimbursement Mechanisms; United States
PubMed: 33942797
DOI: 10.1097/CORR.0000000000001792