Methodological considerations in cross-sectional studies validating the International Classification of Functioning, Disability and Health (ICF) Core-Sets: a systematic review.

PURPOSE: To describe and analyze the methodological characteristics and quality of cross-sectional studies that have validated an ICF-CS. MATERIALS AND METHODS: A systematic review was conducted to identify empirical studies published in English that validated any ICF-CS using a cross-sectional design. Databases searched included Web of Science, Scopus, CINAHL, PubMed, Embase, and PsycINFO. The search was conducted in November 2022 with an update in October 2023. Two independent reviewers coded studies that met the inclusion criteria and assessed their methodological quality and risk of bias using the AXIS tool. Synthesis was performed by calculating frequencies and percentages. RESULTS: 87 articles validating 24 ICF-CSs were analyzed. Most articles showed strengths in consistency between study objectives and the outcome variables measured. However, a large majority did not report sample size calculation (up to 94.2% in Delphi studies), and few validation studies were conducted in the WHO regions of Africa and the Eastern Mediterranean. CONCLUSIONS: The quality of cross-sectional studies validating ICF-CSs was satisfactory, although several articles did not describe aspects such as sample size calculation. Validity evidence for ICF-CS studies could be improved by conducting more multicenter studies, replicating ICF-CS validation studies in different WHO regions, and through synthesis of existing research.

Cross-sectional validation studies of ICF-CSs have satisfactory quality, supporting the use of the CSs in clinical rehabilitation settings similar to those evaluated here.Additional validation studies are required for ICF-CSs that have not yet been validated or for which validity evidence is limited.The methodological findings of this review constitute a roadmap that could guide the development and improve the quality of future ICF-CS validation studies.Knowing which ICF-CSs are validated through cross-sectional designs is useful for planning and designing interventions and instrument development.

Do NPM1 and FLT3-ITD mutations modify prognosis in patients treated with non-intensive regimens?

FLT3-ITD and NPM1 mutations are key to defining the genetic risk profile of acute myeloid leukemia (AML). We aimed to assess the prognostic features of the FLT3-ITD and NPM1 mutations in old and/or unfit individuals with AML treated with non-intensive therapies in the era before azacitidine-venetoclax approbation. The results of various non-intensive regimens were also compared. We conducted a retrospective analysis that included patients treated with different non-intensive regimens, between 2007 and 2020 from PETHEMA AML registry. We compiled 707 patients with a median age of 74 years and median follow-up time of 37.7 months. FLT3-ITD patients (N = 98) showed a non-significant difference in overall survival (OS) compared to FLT3-ITD negative-patients (N = 608) (P = 0.17, median OS was 5 vs 7.3 months respectively). NPM1-mutated patients (N = 144) also showed a non-significant difference with NPM1 wild type (N = 519) patients (P = 0.25, median OS 7.2 vs 6.8 respectively). In the Cox regression analysis neither NPM1 nor FLT3-ITD nor age were significant prognostic variables for OS prediction. Abnormal karyotype and a high leukocyte count showed a statistically significant deleterious effect. Azacitidine also showed better survival compared to FLUGA (low dose cytarabine plus fludarabine). NPM1 and FLT3-ITD seem to lack prognostic value in older/unfit AML patients treated with non-intensive regimens other than azacitidine-venetoclax combination.

Microplastics in stomach contents of juvenile Patagonian blennies (Eleginops maclovinus).

Microplastics are one of the major environmental issues that need to be addressed because they are starting to impact food chains and are also affecting human populations. The size, colour, form, and abundance of microplastics in young blennies of the species Eleginops maclovinus were examined in the current study. While the stomach contents of 70 % of the studied individuals contained microplastics, 95 % of them included fibres. Individual size and the largest particle size that can be eaten, which ranges between 0.09 and 1.5 mm present no statistical correlation. The quantity of particles taken in by each individual does not change with size. The most present microfibers colours were blue and red. Sampled fibres were analysed with FT-IR and no natural fibres were detected, proving the synthetic origin of the detected particles. These findings suggest that protected coastlines create conditions that favour the encounter of microplastics increasing local wildlife exposure to microplastics, raising the danger of their ingestion with potential physiological, ecological, economical and human health consequences.

The antihypertensive and diuretic effect of crude root extract and saponins from Solanum sisymbriifolium Lam., in L-NAME-induced hypertension in rats.

ETHNOPHARMACOLOGICAL RELEVANCE: Solanum sisymbriifolium Lam., is used in Paraguayan folk medicine claiming antihypertensive and diuretic properties. AIM OF THE STUDY: This study aimed to determine the influence of chronic oral administration of the crude root extract and saponins obtained from S. sisymbriifolium Lam., on the blood pressure of male and female rats with hypertension induced by L-NAME, and its consequences on diuresis, the body weight, blood glucose, and level of serum parameters of liver and kidney functionality. MATERIALS AND METHODS: Wistar rats were randomly divided into seven male, and seven female groups (8 animals each), which received as 6-week pretreatment, 0.9% saline solution (two groups; 0.1mL/10 g of b.w.), L-arginine (100.0 mg/kg/day), enalapril (15.0 mg/kg/day), crude extract (CESs 100.0 mg/kg/day), and saponin purified fraction (1.0, and 10.0 mg/kg/day), and treated with L-NAME (20 mg/kg/day/i.p.) twice, 1, and 6 h after pre-treatment. The animals' body weight, glycemia, and blood pressure were recorded weekly, while serum, hepatic, renal, and histological parameters were analyzed at the end of 6-week of treatment. RESULTS: A protective effect of CESs (100.0 mg/kg/day), and saponins (1.0, and 10.0 mg/kg/day) against hypertension induced by L-NAME was verified in the systolic, diastolic, and mean blood pressure values, which were significantly lower than the positive L-NAME-hypertensive control group (male and female) at the end of the 6-week treatment. Also, pretreatment with enalapril (15.0 mg/kg/day) induced an efficient protective activity, which validates the method used. Likewise, the volume of urine, creatinine, uric acid, urea, and electrolyte excretion was enhanced at the end of 6-week of treatment in concordance with the reduction in serum level of the same parameters, compatible with the improvement of the diuretic activity. The glycemia, body weight, heart rate, and functional hepato-renal parameters were not modified after a 6-week of treatment, in comparison to the control group, indicating relatively acceptable harmless properties of CESs and saponins. Interestingly, the HDL level in females was increased in contrast to male rats by chronic saponins treatment when compared with the negative control group. CONCLUSIONS: It can be concluded that either the increment in blood pressure (systolic, diastolic, and median) or cardiorenal remodeling effects in male and female rats submitted to L-NAME-induced hypertensive condition, were prevented and well-preserved without a significant variation during a period of 6-week of pretreatment with CESs and saponins pretreatments. Likewise, an important diuretic effect was revealed after this period of treatment.