Nevin Manimala

Kidney Int. 2021 Nov 1:S0085-2538(21)01020-6. doi: 10.1016/j.kint.2021.09.024. Online ahead of print.

ABSTRACT

Registries are essential for health infrastructure planning, benchmarking, continuous quality improvement, hypothesis generation and real world trials. To date, data from these registries have predominantly been analysed in isolated “silos”, hampering efforts to analyse “big data” at the international level, with wide-ranging benefits including enhanced statistical power, an ability to conduct international comparisons, and greater capacity to study rare diseases. This review serves as a valuable resource to clinicians, researchers, and policymakers by comprehensively describing kidney failure registries active in 2021, before proposing approaches for inter-registry research under current conditions and solutions to enhance global capacity for data collaboration. We identified 79 kidney failure registries spanning 77 countries worldwide. International Society of Nephrology exemplar initiatives, including the “Global Kidney Health Atlas” and “Sharing Expertise to support the set-up of Renal Registries (SharE-RR)” continue to raise awareness regarding international healthcare disparities and support the development of universal kidney disease registries. Current barriers to inter-registry collaboration include under-representation of lower income countries, poor syntactic and semantic interoperability, absence of clear consensus guidelines for healthcare data sharing, and limited researcher incentives. This review represents a call to action for international stakeholders to enact systemic change that will harmonise the current fragmented approaches to kidney failure registry data collection and research.

PMID:34736973 | DOI:10.1016/j.kint.2021.09.024

Prog Biophys Mol Biol. 2021 Nov 1:S0079-6107(21)00125-5. doi: 10.1016/j.pbiomolbio.2021.10.003. Online ahead of print.

ABSTRACT

This response aims to expand on some of the issues raised by Keith Baverstock’s The Gene: An Appraisal, especially on the evolution and nature of knowledge in living things. In contrast to the simple associationism envisaged in “genetic information”, it emphasises the dynamic complexity and changeability of most natural environments, and, therefore, predictability based on underlying statistical structures. That seems to be the basis of the “cognitive” functions increasingly being reported about cellular, as well as more evolved, functions, and of the autonomous agency of organisms thriving creatively in complex environments.

PMID:34736965 | DOI:10.1016/j.pbiomolbio.2021.10.003

Gastrointest Endosc. 2021 Nov 1:S0016-5107(21)01763-6. doi: 10.1016/j.gie.2021.10.026. Online ahead of print.

ABSTRACT

BACKGROUND AND AIMS: With the increasing incidence of small gastrointestinal stromal tumors (GISTs), endoscopic full-thickness resection (EFR) and cap-assisted EFR (EFR-C) have been suggested as 2 effective resection methods. We aimed to compare the outcomes of EFR and EFR-C for the treatment of small (≤ 1.5 cm) gastric GISTs.

METHODS: This retrospective study included 67 patients who underwent EFR and 46 patients who underwent EFR-C at Nanjing Drum Tower Hospital. Clinicopathological features, adverse events and outcomes were compared between the 2 groups. Univariate and multivariate linear and logistic regressions were used to analyze the effects of the procedure on the therapeutic outcomes of patients and adjusted for covariates in multivariate analysis.

RESULTS: The tumor size in the EFR group tended to be larger (P = 0.005). The resection time in the EFR-C group was shorter than that in the EFR group (38.3 ± 20.7 min vs 15.0 ± 11.8 min, P < 0.001), which retained statistical significance with adjustment for the covariates (adjusted mean difference: 22.2; 95% CI, 15.0-29.4, P < 0.001). The R0 resection rate of the EFR group was 94.0%, and for the EFR-C group, it was 97.8% (P = 0.355). The EFR-C group was superior to the EFR group in terms of perioperative therapeutic outcomes, adverse events and postoperative recovery. No recurrence occurred in the EFR and EFR-C groups.

CONCLUSION: EFR-C was found to be the preferable technique for small (≤1.5 cm) gastric GISTs with shorter operation times, lower adverse events, faster postoperative recovery, and shorter hospitalization times as compared with those with EFR.

PMID:34736933 | DOI:10.1016/j.gie.2021.10.026

Ann Thorac Surg. 2021 Nov 1:S0003-4975(21)01832-4. doi: 10.1016/j.athoracsur.2021.09.056. Online ahead of print.

ABSTRACT

BACKGROUND: The Maastricht University Medical Center+ (MUMC+) is a Dutch center of expertise, appointed by the Netherlands Federation of University Medical Centres (NFU), for the treatment of thymomas. The aim of this study was to investigate the long-term oncological-, surgical-, and neurological outcomes of all patients who underwent a robotic thymectomy for a thymoma at the MUMC+.

METHODS: We retrospectively analyzed the clinical-pathological data of all consecutive patients with a thymoma who underwent robotic thymectomy using the DaVinci® Robotic System at the MUMC+ between April 2004 and December 2018. Follow-up data were collected from 60 referring Dutch hospitals.

RESULTS: In total, 398 robotic thymectomies were performed and 130 thymomas (32.7%) were found. Median follow-up time, procedure time and hospitalization were 46 months, 116 minutes and 3 days, respectively. In 8.4% of the patients a conversion was performed and in 20.8% a complication was registered. The majority of myasthenic patients with a thymoma went into remission, mostly within 12 to 24 months after thymectomy (81.0%). No statistical difference was found in the number of complications, conversions, incomplete resections or deaths between patients with myasthenia gravis and nonmyasthenic patients. Thirty-six patients (27.7%) underwent postoperative radiotherapy. The recurrence rate was 9.1% and the five-year thymoma-related survival rate was 96.6% .

CONCLUSIONS: Robotic thymectomy was found to be safe and feasible in early-stage thymomas, most advanced-stage thymomas and thymomatous myasthenia gravis. A national guideline could contribute to the improvement of the oncological follow-up of thymic epithelial tumors in the Netherlands.

PMID:34736927 | DOI:10.1016/j.athoracsur.2021.09.056

Am J Obstet Gynecol. 2021 Nov 1:S0002-9378(21)01183-2. doi: 10.1016/j.ajog.2021.10.034. Online ahead of print.

NO ABSTRACT

PMID:34736916 | DOI:10.1016/j.ajog.2021.10.034

Am J Obstet Gynecol. 2021 Nov 1:S0002-9378(21)01186-8. doi: 10.1016/j.ajog.2021.10.037. Online ahead of print.

ABSTRACT

OBJECTIVE: Limited evidence exists on the role that cause of CKD plays in determining pregnancy outcomes. The aim of this systematic review and meta-analysis was to examine the association between CKD and adverse pregnancy outcomes, by cause and severity of CKD where reported. Protocol registration (PROSPERO, CRD:42020211925).

DATA SOURCES: PubMed, Embase, and Web of Science were searched until May 24, 2021, supplemented with reference list checking.

STUDY ELIGIBILITY CRITERIA: Studies that compared pregnancy outcomes in women with or without CKD were included. Two reviewers independently screened titles, abstracts, and full-text articles according to a priori defined inclusion criteria.

STUDY APPRAISAL AND SYNTHESIS METHODS: Data extraction and quality appraisal were performed independently by three reviewers. The GRADE approach was used to assess the overall certainty of the evidence. Random-effects meta-analyses were used to calculate pooled estimates using the generic inverse variance method. Primary outcomes included pre-eclampsia, Caesarean section (CS), preterm birth (PTB) [<37 wk. gestation] and small for gestational age (SGA).

RESULTS: Of 4,076 citations, 31 studies were included. Pre-pregnancy CKD was associated significantly with a higher risk of pre-eclampsia [pooled crude odds ratio (OR)= 8.13 (95% confidence interval (CI), 4.41-15), and adjusted OR (aOR)=2.58 (1.33-5.01)], CS [aOR=1.65 (1.21-2.25)], PTB [aOR=1.73 (1.31-2.27)] and SGA [aOR= 1.93 (1.06-3.52)]. The association with stillbirth was not statistically significant [aOR=1.67 (0.96-2.92)]. Subgroup analyses indicated that different causes of CKD might confer different risks and that severity of CKD is associated with risk for adverse pregnancy outcomes, as pregnancies with later stages CKD, compared to earlier stages, had higher odds of pre-eclampsia, PTB and SGA. The GRADE certainty of the evidence was ‘very low’ across all outcomes.

CONCLUSIONS: This meta-analysis quantified associations between pre-pregnancy CKD, overall and according to cause and severity, and adverse pregnancy outcomes. These findings might support clinicians aiming to counsel women with CKD, by allowing them to tailor their advice according to cause and severity of CKD. We identified gaps in the literature and further studies examining the effect of specific kidney diseases, and other clinical characteristics (e.g. proteinuria, hypertension), on adverse pregnancy outcomes are warranted.

PMID:34736915 | DOI:10.1016/j.ajog.2021.10.037

Indian Heart J. 2021 Nov 1:S0019-4832(21)00232-7. doi: 10.1016/j.ihj.2021.10.013. Online ahead of print.

ABSTRACT

The microbiological profile, associated risk factors and demographic characteristics of patients with IE has changed in the recent times. In the present study, the antibiotic susceptibility profile of 66 isolates (40 from IDU and 26 from non IDU) recovered over a period of three years from the the patients with definitive diagnosis of IE along with their absolute minimum inhibitory concentrations (MIC-μg/ml) was determined as per CLSI, 2017 guidelines. Staphylococcus aureus was found to be the predominant pathogen associated with IE out of which 90.2% isolates were MRSA, although none of the isolates were found resistant to vancomycin, teicoplanin, daptomycin and linezolid. Pseudomonas aeruginosa isolates were 100% susceptible to carbapenams, however variable resistance was observed against other antimicrobials. All Enterococci were found to be 100% susceptible to linezolid and daptomycin, whereas vancomycin resistant enterococci phenotype was observed in 25% of the Enterococcal isolates. A noticeable difference in the antimicrobial susceptibility profile and their MICs were observed in the present study, as compared to published literature across the globe and within the country. However, no statistically significant difference (λ ² test, p>0.01)in the AST pattern of isolates from IDU vs. Non IDU was observed. After reviewing the local antibiogram it seems that we need to have our own regional guidelines, which may partially replace the currently prevailing AHA/ESC guidelines.

PMID:34736905 | DOI:10.1016/j.ihj.2021.10.013

Clin Biochem. 2021 Nov 1:S0009-9120(21)00282-4. doi: 10.1016/j.clinbiochem.2021.10.011. Online ahead of print.

ABSTRACT

OBJECTIVES: Biotin therapy can affect the results of many immunoassay procedures. The present study investigates biotin’s interference on 25-hydroxy vitamin D(25-OHD), parathyroidhormone(PTH) and thyroid-stimulating hormone(TSH) tests using four different assay systems and biotin neutralization.

DESIGN AND METHODS: Enrolled in the study were 50 children diagnosed with biotinidase deficiency(BTD) undergoing treatment with biotin(5-20 mg/day) who were subjected to a series of analyses involving 25-OHD (Roche Diagnostics assays, Beckman Coulter assays, HPLC, LC/MS-MS), TSH, PTH (Roche Diagnostics assays, Beckman Coulter assays) and biotin (LC/MS-MS), before and after biotin neutralization with Streptavidin-coated magnetic particles(SMP).

RESULTS: The median biotin concentration was found to be 175.2 [94.0-307.1]μg/L. There was no significant difference in the 25-OHD results before and after neutralization with the Beckman Coulter, HPLC and LC-MS/MS assays. In contrast, the median 25-OHD level was seen to decrease from 90.2[35.9-105.3]ng/mL to 29.1[22.6-37.6]ng/mL after neutralization with the Roche assay(p<0.0001). While there was no statistically significant difference in the values recorded before and after neutralization in PTH analysis using Beckman assay, the median PTH levels increased from 7.8[1.6-21.6]pg/mL to 28.2[22.5-41.9]pg/mL after neutralization with the Roche assay(p<0.0001). The cut-off values at which serum biotin interfered in the Roche assay PTH test, with 25-OHD levels determined as 51.4μg/L and 62.9μg/L, respectively. A significant increase was detected in the TSH levels analyzed with a Roche assay after neutralization (from 2.36[1.85-3.00]mIU/L to 2.74[1.93-3.70]mIU/L, p<0.0001).

CONCLUSIONS: The PTH, 25-OHD and TSH results were found to be affected by high biotin concentrations in Roche assays, leading to a risk of misdiagnosis, although SMP neutralization can suppress any such interference efficiently.

PMID:34736903 | DOI:10.1016/j.clinbiochem.2021.10.011

Explore (NY). 2021 Oct 24:S1550-8307(21)00220-2. doi: 10.1016/j.explore.2021.10.004. Online ahead of print.

ABSTRACT

BACKGROUND: hemodialysis patients’ daily use of medications is essential for the disease management. One of the causes of medication non-adherence is that they forget to take medications, and non-adherence to treatment following memory loss is a common problem in patients on hemodialysis.

OBJECTIVE: the current study aimed to compare the effects of Lavender, Rosemary, and Orange essential oils on memory problems (both retrospective and prospective aspects of memory) and medication adherence in hemodialysis patients.

DESIGN: this study was a parallel randomized controlled trial.

SETTING: the two main hemodialysis centers in Kerman, southeastern Iran.

PARTICIPANTS: eighty-six patients under chronic hemodialysis were randomly allocated into four groups (Lavender, Rosemary, Orange, and control) by simple randomization method.

INTERVENTIONS: The samples of the intervention group, in addition to routine care, received Lavender or Rosemary or Orange essential oils three times a week for a month. A gauze containing with five drops of the essential oil was placed at a distance of 10 cm from the patient’s nose one hour after hemodialysis, and the patient was asked to inhale it for 30 min.

MAIN OUTCOME MEASURES: retrospective and prospective memory, and medication adherence were assessed before, immediately and one month after the intervention.

RESULTS: prospective memory problems in Lavender, Rosemary and Orange groups did not change significantly over time (P > 0.05). Prospective memory problems in the control group had a significant increase (P = 0.002). No significant difference was found in prospective memory problems between the four groups (P > 0.05). Retrospective memory problems in the Lavender and Rosemary groups decreased significantly over time (P <0.05). The decreasing retrospective memory problems in the Orange and control groups were not statistically significant over time (P > 0.05). There was no significant difference in retrospective memory problems between the four groups (P > 0.05). No significant difference was observed between the four groups in medication adherence score during the study (P > 0.05).

CONCLUSION: aromatherapy with Lavender or Rosemary can reduce some memory problems in hemodialysis patients. However, the results of this study could not justify the effect of aromatherapy on the rate of medication adherence in patients on hemodialysis, so further studies are required.

TRIAL REGISTRATION: IRCT20190428043410N1.

PMID:34736874 | DOI:10.1016/j.explore.2021.10.004

Glob Chang Biol. 2021 Nov 4. doi: 10.1111/gcb.15972. Online ahead of print.

ABSTRACT

Field studies are essential to reliably quantify ecological responses to global change because they are exposed to realistic climate manipulations. Yet such studies are limited in replicates, resulting in less power and, therefore, unreliable effect estimates. Further, while manipulative field experiments are assumed to be more powerful than non-manipulative observations, it has rarely been scrutinized using extensive data. Here, using 3,847 field experiments that were designed to estimate the effect of environmental stressors on ecosystems, we systematically quantified their statistical power and magnitude (Type M) and sign (Type S) errors. Our investigations focused upon the reliability of field experiments to assess the effect of stressors on both ecosystem’s response magnitude and variability. When controlling for publication bias, single experiments were underpowered to detect response magnitude (median power: 18% – 38% depending on effect sizes). Single experiments also had much lower power to detect response variability (6% – 12% depending on effect sizes) than response magnitude. Such underpowered studies could exaggerate estimates of response magnitude by 2 – 3 times (Type M errors) and variability by 4 – 10 times. Type S errors were comparatively rare. These observations indicate that low power, coupled with publication bias, inflates the estimates of anthropogenic impacts. Importantly, we found that meta-analyses largely mitigated the issues of low power and exaggerated effect size estimates. Rather surprisingly, manipulative experiments and non-manipulative observations had very similar results in terms of their power, Type M and S errors. Therefore, the previous assumption about the superiority of manipulative experiments in terms of power is overstated. These results call for highly powered field studies to reliably inform theory building and policymaking, via more collaboration and team science, and large-scale ecosystem facilities. Future studies also require transparent reporting and open science practices to approach reproducible and reliable empirical work and evidence synthesis.

PMID:34736291 | DOI:10.1111/gcb.15972