Tag: pubmed

Res Social Adm Pharm. 2021 Oct 29:S1551-7411(21)00361-2. doi: 10.1016/j.sapharm.2021.10.008. Online ahead of print.

ABSTRACT

BACKGROUND: Value-based contracts that tie payments for pharmaceuticals to predefined outcomes aim to promote value through shared risk and aligned incentives between manufacturers and payers.

METHODS: We conducted a Delphi study among diverse stakeholders (patients, providers, payers, pharmacy benefits managers, pharmaceutical company representatives) to identify top meaningful outcomes for inclusion in value-based contracts for atrial fibrillation medications. The final panel (n = 55) rated the importance of each outcome on a 5-point Likert scale and selected their top 3 most meaningful outcomes. Non-patient participants rated the feasibility of collecting each outcome on a 5-point Likert scale. Consensus was defined as ≥75% agreement (Likert scores ≥4/5 or selection of an outcome as most meaningful). Differences between stakeholder groups were examined using Fisher’s Exact Test.

RESULTS: Consensus was achieved for importance of 10 outcomes (Likert scale), where “preventing stroke or mini-stroke” reached 100% agreement (55/55). Eighty-one percent (44/54) of participants selected “preventing stroke or mini-stroke” as the most meaningful outcome (rank order question). The measures rated as most feasibly collected were “reducing hospitalizations” (97%, 36/37) followed by “preventing stroke or mini-stroke” and “reducing emergency department visits” (both 92%, 34/37). There were statistically significant differences between patients and non-patients [0% (0/17) vs 22% (8/37), P = 0.047] and patients and providers [0% (0/17) vs 39% (7/18), P = 0.008] in selection of “improving health-related quality of life” as a most meaningful outcome.

CONCLUSIONS: These findings will inform the design of atrial fibrillation value-based pharmaceutical contracts and provide additional insight into preferences for outcomes which could be used to improve the quality of atrial fibrillation care.

PMID:34764046 | DOI:10.1016/j.sapharm.2021.10.008

Int J Health Plann Manage. 2021 Nov 11. doi: 10.1002/hpm.3385. Online ahead of print.

ABSTRACT

BACKGROUND: Supply chain management is essential for cold chain medicines since they are temperature-controlled and must be maintained within a specific temperature range to ensure product integrity and quality. In Nigeria, guidelines that address drug distribution do not adequately address the issue of cold chain management in addition to challenges in implementation. Given the chaotic medicines distribution system, this study examined the quality of practice of supply chain management of cold chain products in line with the World Health Organisation’s Expert Committee report on Specifications for Pharmaceutical Preparations.

METHODS: The study was set in Abuja Nigeria and descriptive survey was used to explore cold chain supply management. A checklist developed from regulatory requirements stipulated by the World Health Organisation covering documentations, storage and distribution guidelines was used to assess supply chain management of cold chain medicines across various facilities. Data were analysed using IBM Statistical Package for the Social Sciences (SPSS) version 25.

RESULTS: The results from this study showed that most of the storage facilities assessed (66.7%) did not meet up to the required standards of quality management for cold chain products. In addition, 50.4% of retail and hospital pharmacy facilities performed poorly in cold chain management practices. Many of aspects of quality management guidelines and regulations were not met by the facilities. Most facilities (66.7%) do not have their equipment calibrated, 43.6% of the hospital and retail pharmacies assessed do not have an automated system to cater for power failure while 37.6% do not perform a temperature check on cold chain products before receiving from suppliers.

CONCLUSION: The study has shown that the levels of the supply chain assessed for quality management and regulatory compliance performed poorly. There was limited availability and use of validated quality monitoring systems for cold chain medicines in these facilities.

PMID:34763368 | DOI:10.1002/hpm.3385

Dig Dis. 2021 Nov 11. doi: 10.1159/000520829. Online ahead of print.

ABSTRACT

Background Colonoscopy surveillance guidelines set the surveillance schedule based on polyp characteristics. Polyps with high-grade dysplasia (HGD) require 3 years of follow-up regardless of size. However, it is unclear whether patients with diminutive polyps (≤5 mm) with HGD have a higher risk. We evaluated the effect of diminutive adenoma with HGD on adenoma occurrence. Methods From Jan 2015 to Dec 2017, patients who underwent index and surveillance colonoscopy were retrospectively screened. The patients were grouped into no adenoma group, low-risk (patients with ≤2 low-grade dysplasia (LGD)), diminutive HGD and high-risk (HGD >5 mm, ≥3 adenomas) groups according to the index colonoscopy results. Each group was analyzed using logistic analysis. Results The mean follow-up period was 22.47 months. Altogether, 610 (50.45%) patients had LGD and 152 (12.5%) had HGD. Among them, 61(5.0%) patients had a diminutive polyp with HGD. Analysis of the risks of developing advanced adenoma in the surveillance colonoscopy showed that compared to no adenoma group, the diminutive HGD group did not show a significant risk (odds ratio [OR]=1.503 [0.449-5.027], p=0.509), while the high-risk group showed a significant risk (odds ratio [OR]=2.044 [1.015-4.114], p=0.045). Conclusions Diminutive adenoma with HGD increased the risk of adenoma on surveillance colonoscopy, In the case of advanced adenoma, the risk was increased, but it was not statistically significant.

PMID:34763334 | DOI:10.1159/000520829

Med J Aust. 2021 Nov 11. doi: 10.5694/mja2.51335. Online ahead of print.

NO ABSTRACT

PMID:34763362 | DOI:10.5694/mja2.51335

Nutrition. 2021 Sep 30;93:111504. doi: 10.1016/j.nut.2021.111504. Online ahead of print.

ABSTRACT

OBJECTIVES: We sought to investigate the effects of time-restricted feeding (TRF) and a traditional weight-loss method on body composition and cardio-metabolic risk factors in middle-aged women.

METHODS: In a single-center, randomized, open-label, parallel-group design, women ages 40 to 65 y with body mass index ≥ 24 kg/m² or waist circumference > 80 cm were recruited. They were guided to a daily low-calorie diet of 1400 kcal and randomly assigned into a TRF group (limit 8 h of eating time and fasting for 16 h) or a non-TRF group (traditional weight-loss method, unrestricted eating time) for 8 wk. Body composition, blood pressure, blood biochemical variables, and insulin resistance status were measured before and after intervention.

RESULTS: Body weight, body mass index, waist circumference, and body fat mass decreased significantly in both groups after 8 wk of intervention (P < 0.05). Body weight decreased more in the TRF group than the non-TRF group (-4.1% ± 2.8% versus -2.4% ± 2.5%; P = 0.012), as did diastolic blood pressure (75.3 ± 11.2 mm Hg versus 70.5 ± 9.4 mm Hg; P = 0.012). There were no statistical differences between the two groups in total cholesterol, triacylglycerols, high- or low-density lipoprotein cholesterol, and fasting insulin level. However, fasting glucose and insulin resistance status increased significantly for the TRF group after the intervention (respectively, 88.3 ± 7.6 mg/dL versus 92.6 ± 9.6 mg/dL, P = 0.003; 1.7 ± 0.7 versus 2.1 ± 1.0, P = 0.048).

CONCLUSION: The weight loss and reduction in diastolic blood pressure using the TRF method were better than with the traditional weight-loss method. However, this method may increase fasting glucose levels and adverse insulin resistance status.

PMID:34763309 | DOI:10.1016/j.nut.2021.111504

Parkinsonism Relat Disord. 2021 Nov 5;93:19-26. doi: 10.1016/j.parkreldis.2021.10.030. Online ahead of print.

ABSTRACT

BACKGROUND: The association between nonalcoholic fatty liver disease (NAFLD) and Parkinson’s disease (PD) remains uncertain. This study sought to assess the sex-specific association between NAFLD and PD risk considering that sex is an important factor in both conditions.

METHODS: We included 2,651,169 men and 2,998,904 women (≥40 years of age) who underwent health examinations in 2009 using database of the Korean National Health Insurance Service. To define NAFLD, the Fatty Liver Index (FLI) was used and a score of at least 60 points was regarded as suggesting the presence of NAFLD. Cox proportional hazards analyses were performed to evaluate the association between the presence of NAFLD/each component of FLI and the risk of PD. All analyses were stratified by sex.

RESULTS: The median follow-up duration was 7.3 years in both men and women. Of the total study population, 23,233 patients with PD (10,578 men and 12,655 women) were identified. Among men, a decreased risk of PD was observed in those with NAFLD [adjusted hazard ratio (aHR): 0.86, 95% confidence interval (CI): 0.82-0.91]. In contrast, among women, an increased risk of PD was observed in those with NAFLD (aHR: 1.09, 95% CI: 1.02-1.16). This different association according to sex was more prominent among younger participants but was not significant in the old age group.

CONCLUSIONS: NAFLD defined by FLI is differently associated with the risk of PD by sex (i.e., low risk of PD in men with NAFLD vs. high risk of PD in women with NAFLD).

PMID:34763304 | DOI:10.1016/j.parkreldis.2021.10.030

Complement Ther Clin Pract. 2021 Oct 26;46:101502. doi: 10.1016/j.ctcp.2021.101502. Online ahead of print.

ABSTRACT

BACKGROUND: and purpose: There is limited evidence from randomised controlled trials (RCTs) regarding the use of yoga and Pilates for the management of urinary incontinence (UI) in women. This study aims to investigate the preliminary effects of using Pilates and yoga to manage UI.

MATERIALS AND METHODS: An assessor-blinded, prospective, three-arm parallel-group randomised controlled pilot trial was conducted in three elderly care centres in Hong Kong. Thirty women aged 60 years or above were included in the study. Study centres were randomly assigned to each of the three interventions (yoga, Pilates and pelvic floor muscle training [PFMT; standard care control]). Study interventions were provided once a week for four weeks, followed by unsupervised CD-guided home exercises for eight weeks. Outcomes included the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), 1-h pad test, and feasibility measures such as adherence to the intervention programme, recruitment and retention rates and safety. Outcomes were assessed at baseline, 4 and 12 weeks. Statistical analysis was performed using two-way repeated measures analysis of covariance.

RESULTS: All three interventions demonstrated a statistically significant effect on ICIQ-SF scores from baseline to weeks 4 and 12. Significant effects in UI were reported for yoga compared with Pilates (mean: -2.93, 95% CI -5.35, -0.51; p = 0.02).

CONCLUSION: Yoga poses intended to address the pelvic floor and core muscles were found to have superior benefits over Pilates exercises in terms of improved continence measured with the ICIQ-SF.

PMID:34763295 | DOI:10.1016/j.ctcp.2021.101502

J Hazard Mater. 2021 Oct 22;424(Pt C):127540. doi: 10.1016/j.jhazmat.2021.127540. Online ahead of print.

ABSTRACT

Monitored Natural Attenuation (MNA) is a preferred remedy for sites contaminated with 1,4-dioxane due to its low cost and limited environmental impacts compared to active remediation. Having a robust estimate of the rate at which biodegradation occurs is an essential component of assessing MNA. In this study, an assay was developed using ¹⁴C-labeled 1,4-dioxane to measure rate constants for biodegradation based on accumulation of ¹⁴C products. Purification of the ¹⁴C-1,4-dioxane stock solution lowered the level of ¹⁴C impurities to below 1% of the total ¹⁴C activity. This enabled determination of rate constants in groundwater as low as 0.0021 yr^-1, equating to a half-life greater than 300 years. Of the 54 groundwater samples collected from 10 sites in the US, statistically significant rate constants were determined with the ¹⁴C assay for 24. The median rate constant was 0.0138 yr^-1 (half-life = 50 yr); the maximum rate constant was 0.367 yr^-1 (half-life = 1.9 yr). The results confirmed that biodegradation of 1,4-dioxane is occurring at 9 of the 10 sites sampled, albeit with considerable variability in the level of activity. The specificity of the assay was confirmed using acetylene and the absence of oxygen to inhibit monooxygenases.

PMID:34763286 | DOI:10.1016/j.jhazmat.2021.127540

Epilepsy Res. 2021 Oct 26;178:106796. doi: 10.1016/j.eplepsyres.2021.106796. Online ahead of print.

ABSTRACT

OBJECTIVE: Patients with epilepsy, mainly drug-resistant, have reduced heart rate variability (HRV), linked to an increased risk of sudden death in various other diseases. In this context, it could play a role in SUDEP. Generalized convulsive seizures (GCS) are one of the most consensual risk factors for SUDEP. Our objective was to assess the influence of GCS in HRV parameters in patients with drug-resistant epilepsy.

METHODS: We prospectively evaluated 121 patients with refractory epilepsy admitted to our Epilepsy Monitoring Unit. All patients underwent a 48-hour Holter recording. Only patients with GCS were included (n = 23), and we selected the first as the index seizure. We evaluated HRV (AVNN, SDNN, RMSSD, pNN50, LF, HF, and LF/HF) in 5-min epochs (diurnal and nocturnal baselines; preictal – 5 min before the seizure; ictal; postictal – 5 min after the seizure; and late postictal – >5 h after the seizure). These data were also compared with normative values from a healthy population (controlling for age and gender).

RESULTS: We included 23 patients, with a median age of 36 (min-max, 16-55) years and 65% were female. Thirty percent had cardiovascular risk factors, but no previously known cardiac disease. HRV parameters AVNN, RMSSD, pNN50, and HF were significantly lower in the diurnal than in the nocturnal baseline, whereas the opposite occurred with LF/HF and HR. Diurnal baseline parameters were inferior to the normative population values (which includes only diurnal values). We found significant differences in HRV parameters between the analyzed periods, especially during the postictal period. All parameters but LF/HF suffered a reduction in that period. LF/HF increased in that period but did not reach statistical significance. Visually, there was a tendency for a global reduction in our patients’ HRV parameters, namely AVNN, RMSSD, and pNN50, in each period, comparing with those from a normative healthy population. No significant differences were found in HRV between diurnal and nocturnal seizures, between temporal lobe and extra-temporal-lobe seizures, between seizures with and without postictal generalized EEG suppression, or between seizures of patients with and without cardiovascular risk factors.

SIGNIFICANCE/CONCLUSION: Our work reinforces the evidence of autonomic cardiac dysfunction in patients with refractory epilepsy, at baseline and mainly in the postictal phase of a GCS. Those changes may have a role in some SUDEP cases. By identifying patients with worse autonomic cardiac function, HRV could fill the gap of a lacking SUDEP risk biomarker.

PMID:34763267 | DOI:10.1016/j.eplepsyres.2021.106796

Breast. 2021 Nov 2;60:230-237. doi: 10.1016/j.breast.2021.11.002. Online ahead of print.

ABSTRACT

PURPOSE: To assess whether contralateral parenchymal enhancement (CPE) on MRI is associated with gene expression pathways in ER+/HER2-breast cancer, and if so, whether such pathways are related to survival.

METHODS: Preoperative breast MRIs were analyzed of early ER+/HER2-breast cancer patients eligible for breast-conserving surgery included in a prospective observational cohort study (MARGINS). The contralateral parenchyma was segmented and CPE was calculated as the average of the top-10% delayed enhancement. Total tumor RNA sequencing was performed and gene set enrichment analysis was used to reveal gene expression pathways associated with CPE (N = 226) and related to overall survival (OS) and invasive disease-free survival (IDFS) in multivariable survival analysis. The latter was also done for the METABRIC cohort (N = 1355).

RESULTS: CPE was most strongly correlated with proteasome pathways (normalized enrichment statistic = 2.04, false discovery rate = .11). Patients with high CPE showed lower tumor proteasome gene expression. Proteasome gene expression had a hazard ratio (HR) of 1.40 (95% CI = 0.89, 2.16; P = .143) for OS in the MARGINS cohort and 1.53 (95% CI = 1.08, 2.14; P = .017) for IDFS, in METABRIC proteasome gene expression had an HR of 1.09 (95% CI = 1.01, 1.18; P = .020) for OS and 1.10 (95% CI = 1.02, 1.18; P = .012) for IDFS.

CONCLUSION: CPE was negatively correlated with tumor proteasome gene expression in early ER+/HER2-breast cancer patients. Low tumor proteasome gene expression was associated with improved survival in the METABRIC data.

PMID:34763270 | DOI:10.1016/j.breast.2021.11.002