Tag: pubmed

Ther Innov Regul Sci. 2022 Feb 5. doi: 10.1007/s43441-022-00379-z. Online ahead of print.

ABSTRACT

OBJECTIVE: Spontaneous reports of adverse drug reactions (ADRs) are an essential data source for pharmacovigilance activities. However, spontaneous reporting is affected by under-reporting, which can lead to bias in statistical signal detection and failure to identify potential drug-associated risks. This study aimed to estimate the degree of under-reporting of suspected serious ADRs (sADRs) in spontaneous reports in Japan.

METHODS: The new active ingredients approved in Japan between 2010 and 2016 for which all-case surveillance was conducted were selected for this study. Data of sADR reports were extracted from the Japanese Adverse Drug Event Report database (JADER). An interrupted time series (ITS) analysis was conducted to compare the number of sADR reports (sADR cases) obtained in the all-case surveillance period with that obtained in the spontaneous report period (after all-case surveillance had been completed).

RESULTS: The ITS analysis of all sADR cases revealed that 24 (68.6%) of the 35 investigated drugs showed a statistically significant decrease in the intercept (level) in the spontaneous reporting period compared with that in the all-case surveillance period. The median of the reduction rate of the level was 60.1%. The number of drugs with a statistically significant decrease in the level of cases with sADRs in the Important Medical Event list and in that leading to death was 19/35(54.3%) and 6/35 (17.1%), respectively.

CONCLUSION: This study demonstrated the existence of sADR under-reporting in spontaneous reports in Japan quantitatively. Meanwhile, it was suggested that information on sADRs was reported appropriately according to their level of severity.

PMID:35124790 | DOI:10.1007/s43441-022-00379-z

Allergy. 2022 Feb 6. doi: 10.1111/all.15247. Online ahead of print.

ABSTRACT

BACKGROUND: Homologous and heterologous SARS-CoV-2 vaccinations yield different spike protein-directed humoral and cellular immune responses. This study aimed to explore their currently unknown interdependencies.

METHODS: COV-ADAPT is a prospective, observational cohort study of 417 healthcare workers who received vaccination with homologous ChAdOx1 nCoV-19, homologous BNT162b2 or with heterologous ChAdOx1 nCoV-19/BNT162b2. We assessed humoral (anti-spike-RBD-IgG, neutralizing antibodies, avidity) and cellular (spike-induced T cell interferon-γ release) immune responses in blood samples up to 2 weeks before (T1) and 2 to 12 weeks following secondary immunization (T2).

RESULTS: Initial vaccination with ChAdOx1 nCoV-19 resulted in lower anti-spike-RBD-IgG compared to BNT162b2 (70±114 vs. 226±279 BAU/ml, p<0.01) at T1. Booster vaccination with BNT162b2 proved superior to ChAdOx1 nCoV-19 at T2 (anti-spike-RBD-IgG: ChAdOx1 nCoV-19/BNT162b2 2387±1627 and homologous BNT162b2 3202±2184 vs. homologous ChAdOx1 nCoV-19 413±461 BAU/ml, both p<0.001; spike-induced T cell interferon-γ release: ChAdOx1 nCoV-19/BNT162b2 5069±6733 and homologous BNT162b2 4880±7570 vs. homologous ChAdOx1 nCoV-19 1152±2243 mIU/ml, both p<0.001). No significant differences were detected between BNT162b2-boostered groups at T2. For ChAdOx1 nCoV-19, no booster effect on T cell activation could be observed. We found associations between anti-spike-RBD-IgG levels (ChAdOx1 nCoV-19/BNT162b2 and homologous BNT162b2) and T cell responses (homologous ChAdOx1 nCoV-19 and ChAdOx1 nCoV-19/BNT162b2) from T1 to T2. Additionally, anti-spike-RBD-IgG and T cell response were linked at both time points (all groups combined). All regimes yielded neutralizing antibodies and increased antibody avidity at T2.

CONCLUSIONS: Interdependencies between humoral and cellular immune responses differ between common SARS-CoV-2 vaccination regimes. T cell activation is unlikely to compensate for poor humoral responses.

PMID:35124800 | DOI:10.1111/all.15247

Ann Biomed Eng. 2022 Feb 5. doi: 10.1007/s10439-022-02922-3. Online ahead of print.

ABSTRACT

The performance of Type I industrial helmets for fall protection is not required to be tested in standardized tests. The current study analyzed the fall protection performance of Type I industrial helmets and evaluated if the use of a chin strap and the suspension system tightness have any effect on protection performance. Head impact tests were performed using an instrumented manikin. There were 12 combinations of test conditions: with or without chin strap usage, three levels of suspension system tightness, and two impact surfaces. Four representative helmet models (two basic and two advanced models) were selected for the study. Impact tests without a helmet under all other applicable test conditions were used as a control group. There were four replicates for each test condition-a total of 192 impact tests with helmets and eight impact tests for the control group. The peak acceleration and the calculated head impact criteria (HIC) were used to evaluate shock absorption performance of the helmets. The results showed that all four helmet models demonstrated excellent performance for fall protection compared to the barehead control group. The fall protection performance of the advanced helmet models was substantially better than the basic helmet models. However, the effects of the use of chin straps and suspension system tightness on the helmets’ fall protection performance were statistically not significant.

PMID:35124769 | DOI:10.1007/s10439-022-02922-3

Eur Arch Otorhinolaryngol. 2022 Feb 6. doi: 10.1007/s00405-022-07261-6. Online ahead of print.

ABSTRACT

INTRODUCTION: Oropharyngeal surgery for Obstructive Sleep Apnea (OSA) has evolved from a radical excision of “redundant” soft tissue for the enlargment of the airway to a minimally invasive reconstruction to fulfill both preservation of pharyngeal function and improvement of sleep apnea. Recently, Alianza surgical technique has been successfully introduced as a new, non-resective procedure aimed to treat concentric pharyngeal collapse at the velum using Barbed Sutures. The aim of this study was to show the effectiveness and safety of Alianza technique as standalone surgical treatment in selected patients with moderate-severe OSA and concentric pharyngeal collapse that refused or did not tolerate Continuous Positive Airway Pressure therapy.

MATERIALS AND METHODS: Effectiveness of the surgical procedure was assessed by means of the Epworth Sleepiness Scale (ESS), Home Sleep Test, and a 0-10 snoring VAS.

RESULTS: At the end of our selection process, 26 patients were enrolled, with a mean age of 52.7 ± 9.2 years, that undergone Alianza tecnique. There was a statistically significant reduction in mean post-operative apnea-hypopnea indexes (34.1 ± 11.5-16.3 ± 10.3; p <0.01), mean oxygen desaturation index (29.0 ± 14.5-13.1 ± 9.2; p < 0.01), and mean ESS scores (12.1 ± 5.8 and 5.8 ± 4.4; p < 0.01).There was also a significant decrease in mean post-operative snoring VAS scores (7.85 ± 1.23 vs 3.2 ± 1.7, p < 0.01). There were no major complications.

CONCLUSIONS: Our preliminary results suggest that Alianza technique is a safe and repeatable surgery. Further studies on a larger scale are needed to confirm these encouraging data supporting the role of Alianza alone or in OSA multilevel surgery in selected OSA patients.

PMID:35124744 | DOI:10.1007/s00405-022-07261-6

J Behav Med. 2022 Feb 5. doi: 10.1007/s10865-022-00291-9. Online ahead of print.

ABSTRACT

Extended-care interventions have been demonstrated to improve maintenance of weight loss after the end of initial obesity treatment; however, it is unclear whether these programs are similarly effective for African American versus White participants. The current study examined differences in effectiveness of individual versus group telephone-based extended-care on weight regain, compared to educational control, in 410 African American (n = 82) and White (n = 328) adults with obesity (mean ± SD age = 55.6 ± 10.3 years, BMI = 36.4 ± 3.7 kg/m²). After controlling for initial weight loss, multivariate linear models demonstrated a significant interaction between treatment condition and race, p = .048. Randomization to the individual telephone condition produced the least amount of weight regain in White participants, while the group condition produced the least amount of weight regain in African American participants. Future research should investigate the role of social support in regain for African American versus White participants and examine whether tailoring delivery format by race may improve long-term outcomes.

PMID:35124742 | DOI:10.1007/s10865-022-00291-9

World J Urol. 2022 Feb 6. doi: 10.1007/s00345-022-03945-0. Online ahead of print.

ABSTRACT

OBJECTIVE: Age is known to have an impact on outcomes after radical prostatectomy (RP). However, age differences can be investigated from a cross-sectional as well as from a longitudinal perspective. This study combines both perspectives.

MATERIALS AND METHODS: LAP-01 is the first multicenter randomized patient blinded trial comparing outcomes after robotic-assisted and laparoscopic RP. This study stratified the entire population that received nerve-sparing surgery and was potent at baseline by the following ages: ≤ 60 years, 61-65 years, and > 65 years. Potency was assessed using the IIEF-5. The EORTC QLQ-C30 was used for global health perception and the EORTC QLQ-PR25 for urinary symptoms. Continence was assessed by the number of pads used. Longitudinal change was assessed using either validated anchor-based criteria or the 1 or 0.5-standard-deviation criterion. Worsening of continence was measured by increasing numbers of pads.

RESULTS: 310 patients were included into this study. Older patients had a significantly higher risk for worsening of continence at 3 and 6 months (OR 2.21, 95% CI [1.22, 4.02], p = 0.009 and OR 2.00, 95% CI [1.16, 3.46], p = 0.013, respectively); at 12 months, the odds of worsening did not differ significantly between age groups. Potency scores were better in younger patients from a cross-sectional perspective, but longitudinal change did not differ between the age groups. In contrast, global health perception was better in older patients from a cross-sectional perspective and longitudinal decreases were significantly more common among the youngest patients, at 12 months (36.9% vs. 24.4%, p = 0.038).

CONCLUSION: From a cross-sectional perspective, function scores were better in younger patients, but from a longitudinal perspective, age differences were found in continence only. In contrast, global health scores were better in older patients from a cross-sectional and longitudinal perspective.

TRIAL REGISTRATION: The LAP-01 trial was registered with the U.S. National Library of Medicine clinical trial registry (clinicaltrials.gov), NCT number: NCT03682146, and with the German Clinical Trial registry (Deutsches Register Klinischer Studien), DRKS ID number: DRKS00007138.

PMID:35124734 | DOI:10.1007/s00345-022-03945-0

Eur J Health Econ. 2022 Feb 6. doi: 10.1007/s10198-022-01439-9. Online ahead of print.

ABSTRACT

The financing structure of the healthcare system and, particularly, the voluntary health insurance (VHI) constituent, has been a vital pillar in improving the overall quality of life. Consequently, this study aims to shed light on the effect of VHI on the population’s health and longevity in a sample of 26 European OECD countries. The methodology employed covers both hierarchical clustering and the novel dynamic panel threshold technique. First, the descriptive cluster analysis unveils a delimitation of the countries into four main groups with respect to a broad set of health status indicators. Second, the estimates show that VHI is a significant determinant of health and longevity. More specifically, we find that the relationship between variables is characterized by a threshold effect, whose estimated value is roughly 6.3% of the total healthcare financing. Also, the heterogeneity analysis unveils consistent differences regarding the impact of VHI on health and longevity for the supplementary and complementary types of VHI. Overall, results are strongly robust, the signs and the significance of the coefficients being preserved in the presence of several additional control factors. From a policy perspective, the study’s findings can be used nationwide to stimulate regulatory policies to encourage the achievement of a satisfactory level of private health insurance.

PMID:35124741 | DOI:10.1007/s10198-022-01439-9

Int Orthop. 2022 Feb 5. doi: 10.1007/s00264-022-05329-w. Online ahead of print.

ABSTRACT

BACKGROUND: Over the last 20 years, suprapatellar (SP) intramedullary nailing has gained considerable attention for treating tibia fractures and is believed to improve fracture alignments, decrease anterior knee pain, and facilitate intraoperative fluoroscopy. However, it is associated with various concerns, including the need to make another infrapatellar (IP) incision to remove the nail.

AIMS: This study was aimed at developing a new technique for the removal of SP tibial nails through an SP approach using a cannulated extraction system. The efficiency of the novel SP approach was compared to that of the traditional IP approach for the removal of SP tibial nails.

PATIENTS AND METHODS: This was a retrospective cohort study from a prospectively collected clinical registry. The data for 69 consecutive patients who received surgery to remove a previous SP intramedullary nail using an SP approach (n = 30, SP cohort) or an IP approach (n = 39, IP cohort) were analyzed. Intra-operative evaluations included intraoperative blood loss, operation time, and changes in the surgical procedures. At six months follow-up, post-operative Lysholm knee score, visual analog scale (VAS) score, and the active range of motion (ROM) of the affected knee and complications were assessed.

RESULTS: Patients in the SP cohort exhibited an increased post-operative Lysholm knee score (β, 2.6; 95% confidence interval [CI], 0.6 to 4.6; P = 0.012), decreased post-operative VAS score (β, – 0.7; 95% CI, – 1.1 to – 0.2; P = 0.004), and increased operation time (β, 9.8 minutes; 95% CI, 5.7 to 14.0 minutes; P < 0.001) compared with those treated with the IP approach after adjustment for baseline characteristics. There were no statistically significant differences in blood loss, post-operative ROM, or complications between the two cohorts.

CONCLUSIONS: Compared with the IP technique, the SP approach for the removal of an SP tibial nail was independently associated with an increased post-operative Lysholm knee score and decreased VAS score, although the surgery was longer in duration. The novel technique offers a reliable and minimally invasive option for the removal of an SP tibial nail.

PMID:35124710 | DOI:10.1007/s00264-022-05329-w

Knee Surg Sports Traumatol Arthrosc. 2022 Feb 6. doi: 10.1007/s00167-022-06887-7. Online ahead of print.

ABSTRACT

PURPOSE: To compare the long-term clinical efficacy provided by intra-articular injections of either Pure Platelet-rich Plasma (P-PRP) or sham saline to treat knee osteoarthritis (KOA).

METHODS: This prospective, parallel-group, double-blind, multi-center, sham-controlled randomized clinical trial recruited participants with KOA from orthopedic departments at nine public hospitals (five tertiary medical centers, four secondary medical units) starting January 1, 2014, with follow-up completed on February 28, 2021. Participants were randomly allocated to interventions in a 1:1 ratio. Data were analyzed from March 1, 2021, to July 15, 2021. Three sessions (1 every week) of P-PRP or sham saline injected by physicians. The primary outcome was the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 3, 6, 12, 24, 60 months of follow-up. Secondary outcomes included the International Knee Documentation Committee (IKDC) subjective score, visual analogue scale (VAS) score, intra-articular biochemical marker concentrations, cartilage volume, and adverse events. Laboratory of each hospital analyzed the content and quality of P-PRP.

RESULTS: 610 participants (59% women) with KOA who received three sessions of P-PRP (n = 308, mean age 53.91 years) or sham saline (n = 302, mean age 54.51 years) injections completed the trial. The mean platelet concentration in PRP is 4.3-fold (95% confidence interval 3.6-4.5) greater than that of whole blood. Both groups showed significant improvements in IKDC, WOMAC, and VAS scores at 1 month of follow-up. However, only the P-PRP group showed a sustained improvement in clinical outcome measurements at month 24 (P < 0.001). There were statistically significant differences between the P-PRP and sham saline groups in all clinical outcome measurements at each follow-up time point (P < 0.001). The benefit of P-PRP was clinically better in terms of WOMAC-pain, WOMAC-physical function and WOMAC-total at 6, 12, 24, and 60 months of follow-up. No clinically significant differences between treatments were documented in terms of WOMAC-stiffness at any follow-up. A clinically significant difference favoring P-PRP group against saline in terms of IKDC and VAS scores was documented at 6, 12, 24 and 60 months of follow-up. At 6 months after injection, TNF-α and IL-1β levels in synovial fluid were lower in the P-PRP group (P < 0.001). Tibiofemoral cartilage volume decreased by a mean value of 1171 mm³ in the P-PRP group and 2311 mm³ in the saline group over 60 months and the difference between the group was statistically significant (intergroup difference, 1140 mm³, 95% CI – 79 to 1320 mm³; P < 0.001).

CONCLUSIONS: In this randomized clinical trial of patients with KOA, P-PRP was superior to sham saline in treating KOA. P-PRP was effective for achieving at least 24 months of symptom relief and slowing the progress of KOA, with both P-PRP and saline being comparable in safety profiles.

PMID:35124707 | DOI:10.1007/s00167-022-06887-7

Clin Neurol Neurosurg. 2022 Feb 1;214:107150. doi: 10.1016/j.clineuro.2022.107150. Online ahead of print.

ABSTRACT

BACKGROUND: Spinocerebellar ataxia (SCA) presents different rates of functional decline depending on the type of ataxia.

OBJECTIVE: To compare the progression of disability, imbalance and severity of ataxia in patients with the three most common types of SCA in southern Brazil.

METHODS: 126 patients (31-SCA2, 58-SCA3 and 37-SCA10) were stratified into four groups based on disease duration. Progression rates were calculated in each group for ataxia severity (SARA), functioning (FIM-ADL and Lawton-IADL), and balance (Berg Balance Scale).

RESULTS: Differences across groups in terms of disease severity revealed a linear pattern of decline in SCA3, with a faster rate over time (p = 0.039) compared to SCA2 and SCA10. The pattern was nonlinear for SCA2 and SCA10, with a twofold faster rate in patients with up to seven years of disease compared to all other periods in SCA10 (p < 0.001) and to the longer follow up period in SCA2 (p = 0.049). Differences across groups regarding worsening of balance scores was significantly faster in SCA3 compared to SCA10 (p = 0.028) and SCA2 (p = 0.028). The rate of loss of independence of ADLs tended to diminish over time in the three types of ataxia and was faster in SCA3. Similarly, the rate for loss of independence (IADLs) was faster in SCA3 compared to SCA2 (p = 0.057) and significantly faster compared to SCA10 (p = 0.028).

CONCLUSION: The present findings suggest that the progression of the disease (severity/functioning/balance) varies according to the SCA subtype and the period in disease course. Progression is more linear and aggressive in patients with SCA3.

PMID:35123369 | DOI:10.1016/j.clineuro.2022.107150