Tag: pubmed

J Clin Pharmacol. 2022 Oct 5. doi: 10.1002/jcph.2162. Online ahead of print.

ABSTRACT

Tacrolimus was frequently used in umbilical cord blood transplant (UCBT) pediatrics for prevention of graft-vs-host disease (GVHD). The aim of the present study was to evaluate the population pharmacokinetics (PPK) of tacrolimus among UCBT pediatrics and find potential influenced factors. A total of 275 concentrations from 13 pediatrics were used to build a PPK model using a non-linear mixed-effects modelling approach. The impact of demographic features, biological characteristics, and concomitant medications, including sex, age, body weight, postoperative day, white blood cell (WBC), red blood cell (RBC), hemoglobin (HB), platelet (PLT), hematocrit (HCT), urea nitrogen (BUN), creatinine (Cr), aspartate transaminase (AST), alanine transaminase (ALT), total bilirubin (TBil), albumin (ALB), and total protein (TP) were investigated. The pharmacokinetics of tacrolimus were best described by a one-compartment model with first- and zero-order mixed absorption and first order elimination. The clearance (CL) and volume of distribution (V) of tacrolimus were 1.93 L/h and 75.1 L, respectively. A covariate analysis identified that postoperative day and co-administration with trimethroprim-sulfamethoxazole (TMP-SMZ) were significant covariates influencing CL of tacrolimus. Frequent blood monitoring and dose adjustment might need with the prolongation of postoperative day and co-administration with TMP-SMZ. This article is protected by copyright. All rights reserved.

PMID:36196568 | DOI:10.1002/jcph.2162

Rev Esp Salud Publica. 2022 Oct 3;96:e202209075.

ABSTRACT

OBJECTIVE: Knowing the risk status of malnutrition and sarcopenia in institutionalized patients is essential to understand the current context after the impact of the coronavirus (COVID-19) pandemic.

METHODS: This research used a retrospective, observational study. The results of the Remote Malnutrition APP test (R-MAPP) are described: risk factors for malnutrition (including COVID-19), the Malnutrition Universal Screening Tool (MUST) and the SARC-F, in a selected sample of 402 residents of Castilla-La Mancha (Spain) during 2021. An inferential analysis was performed to determine which factors were related to the MUST (≥2 points) and SARC-F (≥4 points) response measures. With the factors that obtained statistical significance, a multivariate regression model was performed, adjusting for each one. of those factors.

RESULTS: Mean age was 84.2 years, 70.1% women. Most frequent risk factor for malnutrition was aging (85.1%). The mean body mass index was 26.5 (SD 11.6). MUST≥2 points was obtained in 16.2%, and a SARC-F≥4 in 69.9%. COPD (Chronic obstructive pulmonary disease / OR 0.35; 95% CI 0.13-0.92; p 0.03) was a protective factor against the risk of malnutrition. The risk of sarcopenia was related to aging (OR 8.16; 95% CI 4.13-16.20; p 0.00), COVID-19 (OR 1.96; 95% CI 1.17-3.29; p 0.01) and COPD (OR 2.44; 95% CI 1.21-4.89; p 0.01).

CONCLUSIONS: No relationship is found between COVID-19 and high risk of malnutrition. Aging, COVID-19 and COPD are risk factors for sarcopenia.

PMID:36196560

Rev Esp Salud Publica. 2022 Sep 29;96:e202209074.

ABSTRACT

Non-inferiority studies are increasingly more common for introducing new medicines in the market. Despite being situations where the use of this study design is justified, there is not a common analytical approach on how to conduct them. Pursuing a rigorous methodology, both in the study conduction and in its disseminations, is critical to ensure robust results to enable regulatory agencies and clinicians to reach valid conclusions and decisions which ultimately will benefit clinical practice. Most of the published reviews focus on the efficacy outcomes of non-inferiority clinical trials. We are unaware of other reviews that goes beyond and includes specific aspects for non-interventional designs and for studies focused on safety. Moreover, this review provides a simple and practical perspective with a minimum mathematical content on this complex type of studies.

PMID:36196559

Dent Med Probl. 2022 Jul-Sep;59(3):421-425. doi: 10.17219/dmp/133645.

ABSTRACT

BACKGROUND: Pain from dental injections is a common reason why people fear dentistry and avoid dental treatment. Thus, researchers have attempted to find methods to decrease dental injection pain.

OBJECTIVES: Considering the analgesic effect of the photobiomodulation therapy (PBMT), the aim of this study was to evaluate the effects of PBMT on the pain caused by dental anesthetic injections.

MATERIAL AND METHODS: This randomized, split-mouth, triple-blind clinical trial evaluated 60 bilateral canine teeth in 30 dental students. After the random selection of the test (laser) quadrant, the injection site was irradiated with a 940 nm diode laser. Buccal infiltration anesthesia was then administered by injecting lidocaine plus epinephrine with a short needle. The level of pain experienced during the injection was determined using a 100-millimeter visual analog scale (VAS). The same procedure was performed for the control (no laser) quadrant, with the difference being that the laser handpiece was turned on, but no radiation was administered. The 2 groups were compared using the non-parametric Wilcoxon signed-rank test.

RESULTS: The mean VAS pain scores were 21.2 ±15.7 for the laser quadrant and 27.9 ±18.9 for the control quadrant; this difference was statistically significant (p = 0.030), but did not seem to be clinically relevant.

CONCLUSIONS: The photobiomodulation therapy prior to dental anesthetic injections has no clinical advantage for reducing injection pain.

PMID:36196515 | DOI:10.17219/dmp/133645

Ren Fail. 2022 Dec;44(1):1623-1631. doi: 10.1080/0886022X.2022.2129064.

ABSTRACT

BACKGROUND: A large number of studies have shown that proton pump inhibitors (PPIs) are associated with infection events. Therefore, we retrospectively evaluated the association of PPI therapy with the occurrence of first pneumonia and peritoneal dialysis(PD)-related peritonitis events in the maintenance PD patients.

METHODS: We collected PD patients in two large hospitals from January 1, 2012 to December 31, 2016, and divided them into the PPI group and the non-PPI group. Multivariate Cox proportional hazards models were applied to evaluate the cumulative incidence and hazard ratios (HRs). Inverse probability of treatment weight (IPTW) method was used to adjust for covariate imbalance between the two groups and further confirm our findings.

RESULTS: Finally, 656 PD patients were included for data analysis, and the results showed that PPI usage was associated with an increased risk of pneumonia [HR 1.71; 95% CI 1.06-2.76; p = 0.027] and peritonitis [HR 1.73; 95% CI 1.24-2.40; p = 0.001]. IPTW-adjusted HRs for the association of PPIs with pneumonia and peritonitis were 1.58 (95% CI:1.18-2.12; p = 0.002) and 2.33 (95% CI:1.91-2.85; p < 0.001), respectively. Moreover, the competitive risk model proved that under the conditions of competition for other events(including transfer to hemodialysis therapy, kidney transplant, transfer from our research center, loss to follow-up, and death), the differences in endpoints events between the two groups were still statistically significant (p = 0.009, p < 0.001, respectively).

CONCLUSIONS: PPIs was associated with an increased risk of first pneumonia and PD-related peritonitis events in PD patients, which reminds clinicians to be cautious when prescribing acid-suppressing drugs for PD patients.

PMID:36195979 | DOI:10.1080/0886022X.2022.2129064

Phys Occup Ther Pediatr. 2022 Oct 4:1-14. doi: 10.1080/01942638.2022.2128973. Online ahead of print.

ABSTRACT

AIM: To systematically review evidence of the effectiveness of sticky mittens training to improve reaching skills and manual exploration of full-term and at-risk infants and optimal training dosage.

METHODS: The Cochrane Collaboration and Preferred Reporting Items for Systematic Reviews and Meta-Analyses guided this systematic review. The electronic search was performed from September 2017 to August 2021 on PubMed, Scopus, Science Direct, and Cochrane databases. Eligibility criteria followed PICO terms: clinical trials investigating the effects of sticky mittens training on reaching skills and manual exploration of full-term and at-risk infants. PEDro scale and GRADE assessed methodological quality and quality of evidence, respectively.

RESULTS: Eight studies (313 children) were included. Five studies found statistically significant differences between experimental and control groups (62.6%). One study presented high methodological quality. Evidence synthesis showed very low and low evidence of the beneficial effects of sticky mittens training in full-term and at-risk infants, respectively.

CONCLUSIONS: Findings suggest that sticky mittens training facilitates reaching skills and manual exploration. However, results should interpretation with caution because studies targeted full-term infants. Future research should focus on infants at risk or with motor impairments since sticky mittens training seems to show positive effects and is easy to apply.

PMID:36195977 | DOI:10.1080/01942638.2022.2128973

J Health Popul Nutr. 2022 Oct 4;41(1):45. doi: 10.1186/s41043-022-00326-6.

ABSTRACT

BACKGROUND: Medically unnecessary caesarean section (CS) is now an ongoing concern worldwide including in Bangladesh. This intensifies the occurrence of adverse maternal and child health outcomes. We investigated the associations of CS with some basic health and behavioural outcomes of the mothers and their children in Bangladesh.

METHODS: We conducted a community-based case-control study from May to August 2019. A total of 600 mother-child dyads were interviewed using a structured questionnaire, 300 of them had CS, and 300 had vaginal delivery (VD) in their most recent live births. The exposure variable was the mode of delivery, classified as 1 if mothers had CS and 0 if mothers had VD. The outcome variables were a group of health and behavioural problems of the mothers and their children. Multivariate or multiple logistic regression model, separately for each health and behavioural outcome, was used to determine the effect of exposure variable on outcome variable after adjusting for possible confounders.

RESULTS: The mean age and weight of mothers were 25.1 years and 53.1 kg, respectively. Likelihoods of headache, after delivery hip pain, problem of daily activities, and breastfeeding problem were reported higher among mothers who had CS in their most recent live birth than mothers who had VD. Similarly, children who were born through the CS operation were more likely to report breathing problem, frequent illness, lower food demand and lower hours of sleeping.

CONCLUSION: The use of CS increases the risks of health and behavioural problems of the mothers and their children. Policies and programs to avoid medically unnecessary CS and increase awareness over its adverse effects are important.

PMID:36195965 | DOI:10.1186/s41043-022-00326-6

Pilot Feasibility Stud. 2022 Oct 4;8(1):225. doi: 10.1186/s40814-022-01107-y.

ABSTRACT

BACKGROUND: While international guidelines recommend medication reviews as part of the management of multimorbidity, evidence on how to implement reviews in practice in primary care is lacking. The MyComrade (MultimorbiditY Collaborative Medication Review And Decision Making) intervention is an evidence-based, theoretically informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care.

AIM: The pilot study aimed to assess the feasibility of a definitive trial of the MyComrade intervention across two healthcare systems (Republic of Ireland (ROI) and Northern Ireland (NI)).

DESIGN: A pilot cluster-randomised controlled trial was conducted (clustered at general practice level), using specific progression criteria and a process evaluation framework.

SETTING: General practices in the ROI and NI.

PARTICIPANTS: Eligible practices were those in defined geographical areas who had GP’s and Practice Based Pharmacists (PBP’s) (in NI) willing to conduct medication reviews. Eligible patients were those aged 18 years and over, with multi morbidity and on ten or more medications.

INTERVENTION: The MyComrade intervention is an evidence-based, theoretically informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care, using a planned collaborative approach guided by an agreed checklist, within a specified timeframe.

OUTCOME MEASURES: Feasibility outcomes, using pre-determined progression criteria, assessed practice and patient recruitment and retention and intervention acceptability and fidelity. Anonymised patient-related quantitative data, from practice medical records and patient questionnaires were collected at baseline, 4 and 8 months, to inform potential outcome measures for a definitive trial. These included (i) practice outcomes-completion of medication reviews; (ii) patient outcomes-treatment burden and quality of life; (iii) prescribing outcomes-number and changes of prescribed medications and incidents of potentially inappropriate prescribing; and (iv) economic cost analysis. The framework Decision-making after Pilot and feasibility Trials (ADePT) in conjunction with a priori progression criteria and process evaluation was used to guide the collection and analysis of quantitative and qualitative data.

RESULTS: The recruitment of practices (n = 15) and patients (n = 121, mean age 73 years and 51% female), representing 94% and 38% of a priori targets respectively, was more complex and took longer than anticipated; impacted by the global COVID-19 pandemic. Retention rates of 100% of practices and 85% of patients were achieved. Both practice staff and patients found the intervention acceptable and reported strong fidelity to the My Comrade intervention components. Some practice staff highlighted concerns such as poor communication of the reviews to patients, dissatisfaction regarding incentivisation and in ROI the sustainability of two GPs collaboratively conducting the medication reviews. Assessing outcomes from the collected data was found feasible and appropriate for a definitive trial. Two progression criteria met the ‘Go’ criterion (practice and patient retention), two met the ‘Amend’ criterion (practice recruitment and intervention implementation) and one indicated a ‘Stop – unless changes possible’ (patient recruitment).

CONCLUSION: The MyComrade intervention was found to be feasible to conduct within two different healthcare systems. Recruitment of participants requires significant time and effort given the nature of this population and the pairing of GP and pharmacist may be more sustainable to implement in routine practice.

TRIAL REGISTRATION: Registry: ISRCTN, ISRCTN80017020 ; date of confirmation 4/11/2019; retrospectively registered.

PMID:36195963 | DOI:10.1186/s40814-022-01107-y

Trials. 2022 Oct 4;23(1):846. doi: 10.1186/s13063-022-06668-0.

ABSTRACT

BACKGROUND: Enteral feeding intolerance, energy-protein malnutrition, and muscle wasting are common conditions in the critical care setting. The primary aim of this study was to investigate the effect of synbiotic supplementation on enteral feed volume, energy and protein homeostasis, and muscle mass maintenance in critically ill adult patients.

METHODS: A consecutive of 42 patients admitted to the Edalatian Medical ICU, requiring enteral nutrition (EN), were prospectively randomized to receive the synbiotic capsule (containing a combination of Lactobacillus, Bifidobacterium, Streptococcus, and fructooligosaccharides) or placebo (21 patients in each group) for a maximum of 14 days. Enteral intolerance and energy homeostasis were evaluated on a daily basis. Nitrogen balance and 24-h urine creatinine excretion were recorded on days 1 and 14. Mid-arm circumference was recorded every 3 days.

RESULTS: Mean EN volume, energy, and protein intake per day were 962.5 ± 533.82 ml, 770 ± 427.05 kcal, and 38.5 ± 21.35 g (fourth day) vs. 590 ± 321.1 ml, 472 ± 256.81 kcal, and 23.6 ± 12.84 g (first day) in the synbiotic group (p < 0.05). Changes in the placebo group were not statistically significant. On day 1, nitrogen balance (NB) was – 19.84 ± 8.03 in the synbiotic vs. – 10.99 ± 9.12 in the placebo group (p = 0.003). On day 14, NB was – 14.18 ± 13.05 in the synbiotic and – 9.59 ± 7.71 in the placebo group (p = 0.41). Mid-arm circumference (MAC), 24-h urine creatinine, and creatinine-height index were almost steady in the synbiotic group, while they decreased in the placebo group.

CONCLUSION: Overall, it can be concluded that enteral nutrition supplemented with synbiotics has no statistically significant effect on energy and protein homeostasis and muscle mass maintenance of critically ill patients on day 14, but it can increase enteral feed volume and energy and protein intake during the first 4 days of ICU admission.

TRIAL REGISTRATION: The trial protocol has been approved in Iranian Registry of Clinical Trials on March 17, 2019. The registration reference is IRCT20190227042857N1.

PMID:36195945 | DOI:10.1186/s13063-022-06668-0

Cancer Imaging. 2022 Oct 4;22(1):55. doi: 10.1186/s40644-022-00497-9.

ABSTRACT

OBJECTIVES: To compare the diagnostic performance of international hepatocellular carcinoma (HCC) guidelines with gadoxetic acid-enhanced MRI (EOB-MRI) and contrast-enhanced Computed tomography (CECT) and their impact on liver transplant (LT) allocation in cirrhotic patients with explant histopathology correlation.

METHODS: In this prospective single-centre ethics-approved study, 101 cirrhotic patients were consecutively enrolled with informed consent from the pre-LT clinic. They underwent CECT and EOB-MRI alternately at three monthly intervals until LT or removal from LT list. Two abdominal radiologists, blinded to explant histopathology, independently recorded liver lesions visible on CECT and EOB-MRI. Imaging-based HCC scores were assigned to non-treated liver lesions utilizing Liver Imaging Reporting and Data System (LI-RADS), European Association for the Study of the Liver (EASL), Asian-Pacific Association for the Study of the Liver (APASL) and Korean Liver Cancer Association-National Cancer Center (KLCA) guidelines. Liver explant histopathology was the reference standard. Simulated LT eligibility was assessed as per Milan criteria (MC) in reference to explant histopathology.

RESULTS: One hundred and three non-treated HCC and 12 non-HCC malignancy were identified at explant histopathology in 34 patients (29 men, 5 women, age 55-73 years). Higher HCC sensitivities of statistical significance were observed with EOB-MRI for LI-RADS 4 + 5, APASL and KLCA compared to LI-RADS 5 and EASL with greatest sensitivity obtained for LIRADS 4 + 5 lesions. HCC sensitivities by all guidelines with both EOB-MRI and CECT were significantly lower if all histopathology-detected HCCs were included in the analysis, compared to imaging-visible lesions only. A significantly greater variation in HCC sensitivity was noted across the guidelines with EOB-MRI compared to CECT. No significant differences in simulated LT eligibility based on MC were observed across the HCC scoring guidelines with EOB-MRI or CECT.

CONCLUSION: HCC sensitivities are variable depending on scoring guideline, lesion size and imaging modality utilised. Prior studies that included only lesions visible on pre-operative imaging overestimate the diagnostic performance of HCC scoring guidelines. Per-lesion differences in HCC diagnosis across these guidelines did not impact patient-level LT eligibility based on MC.

PMID:36195953 | DOI:10.1186/s40644-022-00497-9