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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 -
North American Spine Society Journal Mar 2024Increasing evidence demonstrates disparities among patients with differing insurance statuses in the field of spine surgery. However, no pooled analyses have performed a... (Review)
Review
BACKGROUND
Increasing evidence demonstrates disparities among patients with differing insurance statuses in the field of spine surgery. However, no pooled analyses have performed a robust review characterizing differences in postoperative outcomes among patients with varying insurance types.
METHODS
A comprehensive literature search of the PUBMED, MEDLINE(R), ERIC, and EMBASE was performed for studies comparing postoperative outcomes in patients with private insurance versus government insurance. Pooled incidence rates and odds ratios were calculated for each outcome and meta-analyses were conducted for 3 perioperative events and 2 types of complications. In addition to pooled analysis, sub-analyses were performed for each outcome in specific government payer statuses.
RESULTS
Thirty-eight studies (5,018,165 total patients) were included. Compared with patients with private insurance, patients with government insurance experienced greater risk of 90-day re-admission (OR 1.84, p<.0001), non-routine discharge (OR 4.40, p<.0001), extended LOS (OR 1.82, p<.0001), any postoperative complication (OR 1.61, p<.0001), and any medical complication (OR 1.93, p<.0001). These differences persisted across outcomes in sub-analyses comparing Medicare or Medicaid to private insurance. Similarly, across all examined outcomes, Medicare patients had a higher risk of experiencing an adverse event compared with non-Medicare patients. Compared with Medicaid patients, Medicare patients were only more likely to experience non-routine discharge (OR 2.68, p=.0007).
CONCLUSIONS
Patients with government insurance experience greater likelihood of morbidity across several perioperative outcomes. Additionally, Medicare patients fare worse than non-Medicare patients across outcomes, potentially due to age-based discrimination. Based on these results, it is clear that directed measures should be taken to ensure that underinsured patients receive equal access to resources and quality care.
PubMed: 38533185
DOI: 10.1016/j.xnsj.2024.100315 -
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 -
Journal of Medical Internet Research Jun 2023Virtual reality (VR) has potential to improve chronic pain management outcomes. However, the majority of studies assessing VR are conducted in predominantly White... (Review)
Review
BACKGROUND
Virtual reality (VR) has potential to improve chronic pain management outcomes. However, the majority of studies assessing VR are conducted in predominantly White populations in well-resourced settings, thus leaving a gap in knowledge of VR use among diverse populations who experience a significant chronic pain burden.
OBJECTIVE
This review aims to examine the extent to which usability of VR for chronic pain management has been studied within historically marginalized patient groups.
METHODS
We conducted a systematic search to identify studies with usability outcomes located in high-income countries that included a historically marginalized population, defined by a mean age greater than or equal to 65 years, lower educational attainment (greater than or equal to 60% having attained high school education or less), and being a racial or ethnic minority (less than or equal to 50% non-Hispanic White people for studies based in the United States).
RESULTS
Our analysis included 5 papers, which we used to conduct a narrative analysis. Three studies examined VR usability as a primary outcome. All studies assessed VR usability using different measures, of which 4 found VR to be usable by their respective study population. Only 1 study found a significant improvement in pain levels post-VR intervention.
CONCLUSIONS
The use of VR shows promise for chronic pain management, but few studies include populations that are older, have limited educational attainment, or have racial or ethnic diversity. Additional studies with these populations are needed to further develop VR systems that work best for diverse patients with chronic pain.
Topics: Humans; Chronic Pain; Pain Management; Ethnicity; Minority Groups; Virtual Reality
PubMed: 37279039
DOI: 10.2196/40044 -
Biology of Blood and Marrow... Dec 2020Hematopoietic cell transplantation (HCT) is an effective treatment for many hematologic malignancies, and its utilization continues to rise. However, due to the...
Hematopoietic cell transplantation (HCT) is an effective treatment for many hematologic malignancies, and its utilization continues to rise. However, due to the difficult logistics and high cost of HCT, there are significant barriers to accessing the procedure; these barriers are likely greater for older patients. Although numerous factors may influence HCT access, no formal analysis has detailed the cumulative barriers that have been studied thus far. We conducted a systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to better categorize the barriers to access and referral to HCT, with a focus on the subgroup of older patients. We searched for articles published in English from PubMed, Embase, Cumulative Index for Nursing and Allied Health, and Cochrane Central Register of Controlled Trials between the database inception and January 31, 2020. We selected articles that met the following inclusion criteria: (1) study design: qualitative, cross-sectional, observational cohort, or mixed-method study designs; (2) outcomes: barriers related to patient and physician access to HCT; and (3) population: adults aged ≥18 years with hematologic malignancies within the United States. Abstracts without full text were excluded. QUALSYST methodology was used to determine article quality. Data on the barriers to access and referral for HCT were extracted, along with other study characteristics. We summarized the findings using descriptive statistics. We included 26 of 3859 studies screened for inclusion criteria. Twenty studies were retrospective cohorts and 4 were cross-sectional. There was 1 prospective cohort study and 1 mixed-method study. Only 1 study was rated as high quality, and 16 were rated as fair. Seventeen studies analyzed age as a potential barrier to HCT referral and access, with 16 finding older age to be a barrier. Other consistent barriers to HCT referral and access included nonwhite race (n = 16/20 studies), insurance status (n = 13/14 studies), comorbidities (n = 10/11 studies), and lower socioeconomic status (n = 7/8 studies). High-quality studies are lacking related to HCT barriers. Older age and nonwhite race were consistently linked to reduced access to HCT. To produce a more just health care system, strategies to overcome these barriers for vulnerable populations should be prioritized. Examples include patient and physician education, as well as geriatric assessment guided care models that can be readily incorporated into clinical practice.
Topics: Adolescent; Adult; Aged; Cross-Sectional Studies; Hematologic Neoplasms; Hematopoietic Stem Cell Transplantation; Humans; Prospective Studies; Retrospective Studies; United States
PubMed: 32961375
DOI: 10.1016/j.bbmt.2020.09.013 -
BMC Health Services Research Mar 2021The aim of this study was to identify the range of ways that safety net hospitals (SNHs) have been empirically operationalized in the literature and determine the extent...
BACKGROUND
The aim of this study was to identify the range of ways that safety net hospitals (SNHs) have been empirically operationalized in the literature and determine the extent to which patterns could be identified in the use of empirical definitions of SNHs.
METHODS
We conducted a PRISMA guided systematic review of studies published between 2009 and 2018 and analyzed 22 articles that met the inclusion criteria of hospital-level analyses with a clear SNH definition.
RESULTS
Eleven unique SNH definitions were identified, and there were no obvious patterns in the use of a definition category (Medicaid caseload, DSH payment status, uncompensated care, facility characteristics, patient care mix) by the journal type where the article appeared, dataset used, or the year of publication.
CONCLUSIONS
Overall, there is broad variability in the conceptualization of, and variables used to define, SNHs. Our work advances the field toward the development of standards in measuring, operationalizing, and conceptualizing SNHs across research and policy questions.
Topics: Health Services Research; Humans; Medicaid; Safety-net Providers; United States
PubMed: 33766014
DOI: 10.1186/s12913-021-06292-9 -
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 -
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 -
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 Epidemiology Nov 2021We assessed the teratogenicity of tenofovir, a human immunodeficiency virus (HIV) drug similar to remdesivir that is currently being evaluated for the treatment of... (Meta-Analysis)
Meta-Analysis
We assessed the teratogenicity of tenofovir, a human immunodeficiency virus (HIV) drug similar to remdesivir that is currently being evaluated for the treatment of coronavirus disease 2019 (COVID-19). Using US Medicaid Analytic eXtract (MAX) claims data (2000-2014), we identified a population-based pregnancy cohort of women with HIV who filled at least 1 prescription for antiretroviral therapies (ART) during the first trimester. Women on tenofovir disoproxil fumarate (TDF) were compared with women receiving ART without TDF. Major malformations were identified by International Classification of Diseases, Ninth Revision, codes using validated algorithms. Relative risks and 95% confidence intervals were estimated using propensity score stratification to control for potential confounders. We incorporated the results into prior knowledge by conducting a systematic literature review and a meta-analysis. Major congenital malformations were diagnosed in 37 out of 866 (4.27%) infants exposed to TDF and 38 out of 1,020 (3.73%) infants exposed to ART other than TDF; the adjusted relative risk was 1.21 (95% confidence interval: 0.77, 1.90). Estimates for specific malformations were imprecise. The pooled relative risk from the meta-analysis with 6 prior studies was 0.88 (95% confidence interval: 0.75, 1.03). Based on evidence accumulated in patients with HIV, first-trimester TDF use does not increase the risk of major congenital malformations overall in the newborn compared with other ART.
Topics: Adult; Anti-HIV Agents; Antiviral Agents; COVID-19; Cohort Studies; Female; HIV Infections; Humans; Pandemics; Pregnancy; Pregnancy Complications, Infectious; Pregnancy Outcome; Pregnant Women; Reverse Transcriptase Inhibitors; SARS-CoV-2; Tenofovir; COVID-19 Drug Treatment
PubMed: 33847737
DOI: 10.1093/aje/kwab109