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Financial hardship from purchasing prescription drugs among older adults in the United States before, during, and after the Medicare Part D “Donut Hole”: Findings from 1998, 2001, 2015, and 2021

J Manag Care Spec Pharm. 2022 May;28(5):508-517. doi: 10.18553/jmcp.2022.28.5.508.

ABSTRACT

BACKGROUND: Cost-related nonadherence compromises successful and effective management of chronic disease. The Medicare Modernization Act of 2003 (MMA) and Patient Protection and Affordable Care Act of 2010 (ACA) aimed to increase the affordability of outpatient prescription drugs for older adults (older than age 64 years). The Medicare Part D prescription drug insurance coverage gap (“donut hole”) created by the MMA was fully closed in 2020 by the ACA. OBJECTIVES: To (1) describe prescription drug coverage and financial hardship from purchasing prescription drugs among older American adults for 2021, (2) compare these results with findings from data collected before the MMA and during the progressive elimination of the Medicare Part D coverage gap, and (3) compute the likelihood for financial hardship from purchasing prescription drugs using variables for year, prescription drug insurance coverage, health-related information, and demographics. METHODS: Data were obtained from 4 nationally distributed, crosssectional surveys of older adults to track coverage for and financial hardship from purchasing prescription drugs. Surveys in 1998 and 2001 were mailed to national random samples of US seniors. Of 2,434 deliverable surveys, 700 (29%) provided useable data. Data were collected in 2015 and 2021 via online surveys sent to samples of US adults. Of 27,694 usable responses, 4,445 were from older adults. Descriptive statistics and logistic regression analyses described relationships among financial hardship and demographics, diagnoses, and daily prescription drug use. RESULTS: Five percent of older adults lacked prescription drug coverage in 2021, continuing a downward trend from 32% in 1998, 29% in 2001, and 9% in 2015. Contrastingly, 20% of older adults reported financial hardship from prescription drug purchases in 2021, bending an upward trend from 19% in 1998, 31% in 2001, and 36% in 2015. Financial hardship from purchasing prescription drugs was more likely to be reported by older adults lacking prescription drug insurance, taking multiple medications daily, and having a low annual household income across all survey years. The latter 2 of these 3 factors were still predictive of financial hardship from purchasing prescription drugs among older adults with prescription drug insurance. CONCLUSIONS: Financial hardship from purchasing prescription drugs is still experienced by many older adults after the full implementation of the MMA and ACA. Lacking prescription drug coverage, taking more than 5 prescription drugs daily, and a low annual household income may increase the likelihood of experiencing this financial hardship. Pharmacists can be a resource for older adults making choices about their prescription drug coverages and purchases. DISCLOSURES: Funding was provided by the American Association of Colleges of Pharmacy New Investigator Program, the University of Minnesota Grant-in-Aid of Research Program, the Peters Endowment for Pharmacy Practice Innovation, the Chapman University Research Program, and the University Minnesota Research Program.

PMID:35471065 | DOI:10.18553/jmcp.2022.28.5.508

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Vascular ultrasonography in the preparation and surveillance of arteriovenous fistula: a monocentric experience

G Ital Nefrol. 2022 Apr 21;39(2):2022-vol2.

ABSTRACT

Creating an arteriovenous fistula (AVF) is complicated by the gradual increase in the average age of patients initiating chronic haemodialysis treatment and by the greater prevalence of pathologies that impact the cardiovascular system. In the past, the choice of which vessels to use for the creation of the AVF was essentially based on the physical examination of the upper limbs. Current international guidelines suggest that a colour doppler ultrasound (DUS) should be performed to complete the physical examination. Similarly, vascular ultrasound is fundamental in the post-operative phase for appropriately monitoring the access. We have conducted a retrospective analysis on the use of DUS in clinical practice in our centre, in order to determine the repercussions on vascular access survival. To this end, we identified three phases, according to the methods that were used for pre-operative vascular evaluation and monitoring of the AVF, that saw the progressive integration of clinical and ultrasound parameters. The analysis of the data highlighted a statistically significant higher rate of survival for all vascular accesses, evaluated as a whole, and for distal AVFs, in the third phase, despite a greater percentage of patients over 75 (48% vs 28%). In conclusion, we believe that an approach integrating clinical and ultrasound evaluation is indispensable to identify the most suitable AVF site and guarantee its efficiency over time.

PMID:35470998

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Sarcopenia and catastrophic health expenditure by socio-economic groups in China: an analysis of household-based panel data

J Cachexia Sarcopenia Muscle. 2022 Apr 26. doi: 10.1002/jcsm.12997. Online ahead of print.

ABSTRACT

BACKGROUND: Sarcopenia was thought to be associated with adverse outcomes and will cause lots of health expenditure. But the relationship between sarcopenia and catastrophic health expenditure (CHE) had been little explored. Here, we examined the distribution of sarcopenia in relation to medical and payment burdens.

METHODS: We used data from three waves of China Health and Retirement Longitudinal Study including 14 130 participants from 9077 households aged over 50 years old. Sarcopenia was operationalized according to the Asian Working Group for Sarcopenia 2019. Medical expenditure was obtained by self-reported data, and CHE was identified by WHO definitions. We used the negative binomial regression model and logistic mixed-effects models to examine the associations between sarcopenia and medical and CHE.

RESULTS: A total of 14 130 participants [52.2% female, aged 60.8 (SD 9.3)] from 9077 households were included in this study. The prevalence of sarcopenia was 19.8%, 11.9% for moderate sarcopenia, and 7.9% for severe sarcopenia, respectively. We identified 1416 household CHE events in all three waves. Severe sarcopenia was associated with an increase in the number of inpatient visits [incidence rate ratio 1.31, 95% confidence interval (CI): 1.03-1.66, P = 0.03] and the risk of CHE (odds ratio: 1.04, 95% CI: 1.01-1.07, P < 0.01). We saw similar effects in health service use of sarcopenia in different socio-economic groups. Moderate sarcopenia increased the risk of CHE in the lowest socio-economic group (odds ratio 1.03, 95% CI: 1.01-1.06, P = 0.03) and had no statistical significance in other groups. The association between severe sarcopenia and CHE did not attenuate after the adjustment of disease factors.

CONCLUSIONS: Severe sarcopenia may increase the risk of CHE. Timely and effective intervention on moderate sarcopenia from severe sarcopenia will contribute to reduce the health burden.

PMID:35470981 | DOI:10.1002/jcsm.12997

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The effect of different wound dressing materials used in postoperative treatment of wounds after total hip arthroplasty and total knee arthroplasty: A meta-analysis

Int Wound J. 2022 Apr 26. doi: 10.1111/iwj.13816. Online ahead of print.

ABSTRACT

A meta-analysis was performed to assess the effect of different wound dressing materials used in the postoperative treatment of wounds after total hip arthroplasty (THA) and total knee arthroplasty (TKA). A systematic literature search up to January 2022 incorporated 16 trials involving 2765 subjects after THA or TKA at the beginning of the study: 1447 were using active and interactive dressings, and 1318 were using passive dressings. The statistical tools like the dichotomous or continuous method were used within a random or fixed-influence model to establish the odds ratio (OR) and mean difference (MD) with 95% confidence intervals (CIs) to evaluate the influence of different wound dressing materials used in postoperative treatment of wounds after THA and TKA. Active and interactive dressings had significantly lower overall wound complications (OR, 0.32; 95% CI, 0.26-0.40, P < 0.001), number of dressing changes (MD, -1.53; 95% CI, -2.09 to -0.96, P < 0.001), and early dressing change need (OR, 0.14; 95% CI, 0.04-0.47, P = 0.002) compared with passive dressings for subjects after THA and TKA. Active and interactive dressings had significantly lower overall wound complications, the number of dressing changes, and early dressing change need compared with passive dressings for subjects after THA and TKA. Furthermore, evidence is needed to confirm the outcomes.

PMID:35470964 | DOI:10.1111/iwj.13816

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Care Pathways in Atopic Dermatitis: A Retrospective Population-Based Cohort Study

J Eur Acad Dermatol Venereol. 2022 Apr 26. doi: 10.1111/jdv.18185. Online ahead of print.

ABSTRACT

BACKGROUND: Atopic dermatitis (AD) is a complex disease with variations in severity and healthcare utilization. Examining patient pathways through analyses of longitudinal patient data provides an opportunity to describe real-world clinical patient care and evaluate healthcare access and treatment.

OBJECTIVE: To describe longitudinal care pathways including health care management, treatment patterns and disease progression (by proxy measures) in patients with AD.

MATERIAL AND METHODS: This was a longitudinal observational study which used linked data from national and regional healthcare registers in Sweden. Patients with AD were identified through diagnosis in primary or secondary care or by dispensed medications. Descriptive statistics for number of healthcare visits, type of dispensed drug class, rate of – and time to – referral to secondary care and treatment escalation were calculated.

RESULTS: A total of 341,866 patients with AD distributed as 197,959 pediatric (age <12), 36,133 adolescent (age ≥12-<18) and 107,774 adult (age ≥18) patients were included in this study. Healthcare visits to primary and secondary care and dispensation of AD-indicated treatments were more common during the year in which managed AD care was initiated. Topical corticosteroids (TCSs) and emollients were the most frequently used treatments across all age-cohorts while systemic treatment was uncommon in all age-cohorts. Among patients who initiated treatment with TCSs, 18.2% escalated to TCSs with higher potency following the start of managed AD care.

CONCLUSIONS: We found that healthcare contacts and use of AD-indicated treatments were concentrated in the year during which managed AD care was initiated and decreased significantly thereafter. Since a significant proportion of patients with AD have flares and persistent AD, our results suggest that patients with AD may be monitored infrequently and are undertreated. There is a need to inform practitioners about adequate treatment options to provide individualized care, in particular for patients with persistent severe AD.

PMID:35470924 | DOI:10.1111/jdv.18185

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Prevalence, progression, and management of advanced chronic kidney disease in a cohort of people living with HIV

HIV Med. 2022 Apr 26. doi: 10.1111/hiv.13317. Online ahead of print.

ABSTRACT

BACKGROUND: Advanced kidney disease is an emerging problem in people living with HIV despite sustained viral suppression.

METHODS: We performed a prospective cohort study to identify people living with HIV with advanced kidney disease according to the Kidney Disease Improving Global Outcomes criteria and to assess disease progression over a 48-week period following the offer of targeted multidisciplinary management.

RESULTS: From our cohort of 3090 individuals, 55 (1.8%, 95% confidence interval [CI] 1.31-2.25) fulfilled the inclusion criteria. Most were male (83.6%), and the median (interquartile range [IQR]) age was 58 (53.25-66.75) years. Nadir CD4 T-cell count was 135.5 (IQR 43.5-262.75) cells/μl, current CD4 T-cell count was 574 (IQR 438.5-816) cells/μl, and 96% had maintained HIV viral suppression. The most frequent comorbidity was arterial hypertension (85.5%). Inadequate antiretroviral dose was detected in three individuals (5.5%), and drug-drug interactions were recorded in eight (14.5%), mainly involving the use of cobicistat (n = 5 [9%]). Four individuals (7%) required modification of their concomitant treatment. Seven (13%) had to start or resume follow-up with a nephrologist. Nine participants (16.4%) experienced an improvement in kidney disease stage, three individuals (5.5%) underwent renal transplantation, and one (2%) started haemodialysis.

CONCLUSIONS: Our results show that a multidisciplinary approach, including a critical review of treatment and evaluation of specific requirements, could be useful for anticipating drug-drug interactions and toxicities and for reducing death and hospitalization in people living with HIV with advanced kidney disease.

PMID:35470944 | DOI:10.1111/hiv.13317

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Real-world evidence from over one-million COVID-19 vaccinations is consistent with reactivation of the varicella-zoster virus

J Eur Acad Dermatol Venereol. 2022 Apr 26. doi: 10.1111/jdv.18184. Online ahead of print.

ABSTRACT

BACKGROUND: Reactivation of the varicella-zoster virus (VZV), which causes herpes zoster (HZ, synonym: shingles) in humans, can be a rare adverse reaction to vaccines. Recently, reports of cases after COVID-19 vaccination have arisen.

OBJECTIVES: The aim of this study was to assess if the frequency of HZ is found to increase after COVID-19 vaccination in a large cohort, based on real-world data. As a hypothesis, the incidence of HZ was assumed to be significantly higher in subjects who received a COVID-19 vaccine (Cohort I) versus unvaccinated individuals (Cohort II).

METHODS: Initial cohorts of 1,095,086 vaccinated and 16,966,018 unvaccinated patients were retrieved from the TriNetX database, and were matched on age and gender in order to mitigate confounder bias.

RESULTS: After matching, each cohort accounted for 1,095,086 patients. For the vaccinated group (Cohort I), 2,204 subjects developed HZ within 60 days of COVID-19 vaccination, while among Cohort II, 1,223 patients were diagnosed with HZ within 60 days after having visited the clinic for any other reason (i.e., not vaccination). The risk of developing shingles was calculated as 0.20% and 0.11% for cohort I and cohort II, respectively. The difference was statistically highly significant (p < 0.0001; log-rank test). The risk ratio and odds ratio were 1.802 (95% confidence interval [CI] = 1.680; 1.932) and 1.804 (95% CI = 1.682; 1.934).

CONCLUSIONS: Consistent with the hypothesis, a higher incidence of HZ was statistically detectable post-COVID-19 vaccine. Accordingly, eruption of HZ may be a rare adverse drug reaction to COVID-19 vaccines. Even though the molecular basis of VZV reactivation remains murky, temporary compromising of VZV-specific T cell-mediated immunity may play a mechanistic role in post-vaccination pathogenesis of HZ. Note that VZV reactivation is a well-established phenomenon both with infections and with other vaccines (i.e., this adverse event is not COVID-specific).

PMID:35470920 | DOI:10.1111/jdv.18184

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Probiotics for the prevention of Hirschsprung-associated enterocolitis

Cochrane Database Syst Rev. 2022 Apr 26;4:CD013714. doi: 10.1002/14651858.CD013714.pub2.

ABSTRACT

BACKGROUND: Hirschsprung-associated enterocolitis (HAEC) is a leading cause of serious morbidity and potential mortality in children with Hirschsprung’s disease (HD). People with HAEC suffer from intestinal inflammation, and present with diarrhoea, explosive stools, and abdominal distension. Probiotics are live microorganisms with beneficial health effects, which can optimise gastrointestinal function and gut flora. However, the efficacy and safety of probiotic supplementation in the prevention of HAEC remains unclear.

OBJECTIVES: To assess the effects of probiotic supplements used either alone or in combination with pharmacological interventions on the prevention of Hirschsprung-associated enterocolitis.

SEARCH METHODS: We searched CENTRAL, PubMed, Embase, the China BioMedical Literature database (CBM), the World Health Organization International Clinical Trials Registry, ClinicalTrials.gov, the Chinese Clinical Trials Registry, Australian New Zealand Clinical Trials Registry, and Clinical Trials Registry-India, from database inception to 27 February 2022. We also searched the reference lists of relevant articles and reviews for any additional trails.

SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing probiotics and placebo, or any other non-probiotic intervention, for the prevention of HAEC were eligible for inclusion.

DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the risk of bias of the included studies; disagreements were resolved by discussion with a third review author. We assessed the certainty of evidence using the GRADE approach. We calculated odds ratios (ORs) with 95% confidence intervals (CIs) for dichotomous outcomes.

MAIN RESULTS: We included two RCTs, with a total of 122 participants. We judged the overall risk of bias as high. We downgraded the evidence due to risk of bias (random sequence generation, allocation concealment, and blinding) and small sample size. The evidence is very uncertain about the effect of probiotics on the occurrence of HAEC (OR 0.58, 95% CI 0.10 to 3.43; I² = 74%; 2 studies, 120 participants; very low-certainty evidence). We found one included study that did not measure serious adverse events and one included study that reported no serious adverse events related to probiotics. Probiotics may result in little to no difference between probiotics and placebo in relation to the severity of children with HAEC at Grade I (OR 0.66, 95% CI 0.14 to 3.16; I² = 25%; 2 studies, 120 participants; low-certainty evidence). The effects of probiotics on the severity of HAEC at Grade II are very uncertain (OR 1.14, 95% CI 0.01 to 136.58; I² = 86%; 2 studies, 120 participants; very low-certainty evidence). Similarly, the evidence suggests that probiotics results in little to no difference in relation to the severity of HAEC at Grade III (OR 0.43, 95% CI 0.05 to 3.45; I² = 0%; 2 studies, 120 participants; low-certainty evidence). No overall mortality or withdrawals due to adverse events were reported. Probiotics may result in little to no difference in the recurrence of episodes of HAEC compared to placebo (OR 0.85, 95% CI 0.24 to 3.00; 1 study, 60 participants; low-certainty evidence).

AUTHORS’ CONCLUSIONS: There is currently not enough evidence to assess the efficacy or safety of probiotics for the prevention of Hirschsprung-associated enterocolitis when compared with placebo. The presence of low- to very-low certainty evidence suggests that further well-designed and sufficiently powered RCTs are needed to clarify the true efficacy of probiotics.

PMID:35470864 | DOI:10.1002/14651858.CD013714.pub2

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Pragmatic Uncontrolled Study of Specialized Cognitive Behavioral Therapy for Adults With Chronic Tinnitus

Ear Hear. 2022 Apr 25. doi: 10.1097/AUD.0000000000001226. Online ahead of print.

ABSTRACT

OBJECTIVES: Tinnitus is the perception of sound without an external source, affecting quality of life that can cause severe distress in approximately 1 to 3% of the population of people with tinnitus. Randomized controlled trials of cognitive behavioral therapy for tinnitus have demonstrated its effectiveness in improving quality of life, but the effects of their implementation on a large scale in routine practice remains unknown. Therefore, the main purpose of this study was to examine the effects of stepped-care cognitive behavioral therapy for tinnitus delivered in a tertiary audiological center of a regional hospital. Second, we wished to examine predictors of favorable outcome.

DESIGN: Four hundred three adults with chronic tinnitus were enrolled in this prospective observational study (at 3 months, N=334, 8 months, N=261; 12 months, N=214). The primary outcome was health-related quality of life as measured by the Health Utilities Index III (HUI-III) at 12 months. Secondary outcomes were self-reported levels of tinnitus-related distress, disability, affective distress and tinnitus-related negative beliefs and fear. Measures were completed pre-intervention at 3 months, 8 months, and 12 months. Multilevel modeling was used to examine effects and their predictors.

RESULTS: Younger participants with lower levels of tinnitus distress were more likely to dropout while those with higher tinnitus distress at baseline and quality of life were more likely to receive step 2 of treatment. MLM analyses revealed, with one exception, no relation between any baseline variable and outcome change over time. Most participants’ improvement exceeded minimally clinical important difference criteria for quality of life, tinnitus-related handicap, and tinnitus distress.

CONCLUSIONS: Results from this large pragmatic study complements those from randomized controlled trials of cognitive behavioral therapy for chronic tinnitus distress and supports its implementation under “real-world” conditions.

PMID:35470813 | DOI:10.1097/AUD.0000000000001226

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Hearing Impairment in the Extended High Frequencies in Children Despite Clinically Normal Hearing

Ear Hear. 2022 Apr 25. doi: 10.1097/AUD.0000000000001225. Online ahead of print.

ABSTRACT

OBJECTIVES: Pediatric hearing impairment, regardless of degree and type, has a detrimental effect on speech perception, cognition, oral language development, academic outcomes, and literacy. Hearing assessment in the clinic is limited to 8 kHz although humans can hear up to 20 kHz. Hearing impairment in the extended high frequencies (EHFs > 8 kHz) can occur despite clinically normal hearing. However, to date, the nature and effects of EHF hearing impairment in children remain unknown. The goals of the present study were to determine the effects of EHF hearing impairment on speech-in-noise recognition in children and to examine whether hearing impairment in the EHFs is associated with altered cochlear functioning in the standard frequencies.

DESIGN: A volunteer sample of 542 participants (4 to 19 years) with clinically normal audiograms were tested. Participants identified with EHF impairment were assigned as cases in a subsequent case-control study. EHF loss was defined as hearing thresholds greater than 20 dB in at least one EHFs (10, 12.5, or 16 kHz). Speech recognition thresholds in multi-talker babble were measured using the digit triplet test. Distortion product otoacoustic emissions (f2 = 2, 3, 4, and 5 kHz) were measured to assess cochlear functioning.

RESULTS: Thresholds in the EHFs were as reliable as those in the standard frequency range. Thirty-eight children had EHF hearing impairment regardless of a clinically normal audiogram. A linear mixed-effects model revealed that children with EHF hearing impairment had higher (poorer) mean speech recognition threshold than children with normal EHF sensitivity (estimate = 2.14 dB, 95% CI: 1.36 to 3.92; effect size = small). The overall magnitude of distortion product otoacoustic emissions was lower for children with EHF impairment (estimate = -2.47 dB, 95% CI: -4.60 to -0.73; effect size = medium). In addition, the pure-tone average for standard audiometric frequencies was relatively higher for EHF-impaired children (estimate = 3.68 dB, 95% CI: 2.56 to 4.80; effect size = small).

CONCLUSIONS: Hearing impairment in the EHFs is common in children despite clinically normal hearing and can occur without a history of otitis media. EHF impairment is associated with poorer speech-in-noise recognition and preclinical cochlear deficits in the lower frequencies where hearing thresholds are normal. This study highlights the clinical need to identify EHF impairments in children.

PMID:35470812 | DOI:10.1097/AUD.0000000000001225