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Gerardo González-Saldivar,1 René Rodríguez-Gutiérrez,2 José Luis Viramontes-Madrid,3 Alejandro Salcido-Montenegro,2 Kevin Erick Gabriel Carlos-Reyna,2 Andrés Marcelo Treviño-Alvarez,2 Neri Alejandro Álvarez-Villalobos,4 José Gerardo González-González2 1Ophthalmology Department, 2Endocrinology Division, Hospital Universitario “Dr. José E. González”, Facultad de Medicina, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, 3Instituto Nacional de Salud Pública, Cuernavaca, Morelos, 4Medical Statistics Department, Hospital Universitario “Dr. José E. González”, Facultad de Medicina, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico Background: There is scarce scientific information assessing participants’ perception of pharmaceutical research in developed and developing countries concerning the risks, safety, and purpose of clinical trials.Methods: To assess the perception that 604 trial participants (cases) and 604 nonparticipants (controls) of pharmaceutical clinical trials have about pharmaceutical clinical research, we surveyed participants with one of four chronic diseases from 12 research sites throughout Mexico.Results: Participation in clinical trials positively influences the perception of pharmaceutical clinical research. More cases (65.4%) than controls (50.7%) perceived that the main purpose of pharmaceutical research is to cure more diseases and to do so more effectively. In addition, more cases considered that there are significant benefits when participating in a research study, such as excellent medical care and extra free services, with this being the most important motivation to participate for both groups (cases 52%, controls 54.5%). We also found a sense of trust in their physicians to deal with adverse events, and the perception that clinical research is a benefit to their health, rather than a risk. More controls believed that clinical trial participants’ health is put at risk (57% vs 33.3%). More cases (99.2%) than controls (77.5%) would recommend participating in a clinical trial, and 90% of cases would enroll in a clinical trial again.Conclusion: Participation in clinical trials positively influences the perception that participants have about pharmaceutical clinical research when compared to nonparticipants. This information needs to be conveyed to clinicians, public health authorities, and general population to overcome misconceptions. Keywords: perceptions, clinical trials, chronic disorders, participants’ perception, pharmaceutical industry, developing countries

Background: Cerebral palsy (CP) comprises a group of lifelong motor and postural development disorders that can cause static motor encephalopathy. The etiology of CP is attributed to nonprogressive lesions of the central nervous system during fetal or infant brain development. A diagnosis of CP is based on a combination of clinical and neurological signs, typically identified between 12 and 24 months. A medical history, several available standardized tools, including the Neoneuro assessment, and the Hammersmith infant neurological examination (HINE) can be used to predict risk. Magnetic resonance imaging (MRI) can contribute to the diagnosis of CP. The incidence of CP is 2 to 3 per 1000 live births, and in Western industrialized nations, it is 2.0-2.5 per 1000 live births; to our knowledge, no epidemiological studies have reported the incidence of CP in Mexico., Aim: To assess the incidence of CP in children aged up to 18 months in northeast Mexico and analyze the risk factors and neuroimaging findings., Methods: This was a multicenter, randomized, prospective, cohort, analytical study of newborn children in three community hospitals and an early intervention and CP center in Nuevo Leon, Mexico, from 2017 to 2021. This study included 3861 newborns randomly selected from a population of 75,951 mothers in the immediate puerperium. According to the Neoneuro tool, high-risk children (n = 432) had abnormal neurological results at birth; they were followed and assessed with the Spanish version of the HINE test by a pediatric neurologist and underwent neuroimaging studies. Neonates with normal results were randomly selected to be in the low-risk group (n= 864). These neonates were followed and assessed with the HINE by a neonatologist., Results: The incidence of CP was 4.4 of 1000 up to 18 months old, which was higher than that reported in developed countries. Perinatal risk factors were predominantly recognized in the etiology of CP, such as brain hemorrhage, and prematurity, in addition to congenital anomalies. The most frequent neuroimaging findings were ventricular dilation/cortical atrophy and intraventricular/subependymal hemorrhage and periventricular leukomalacia on MRI., Conclusions: This study is the first on the incidence/prevalence of CP in Mexico, and there are no formal studies in this field in other Latin American countries either. The incidence of CP in northeast Mexico is higher than that reported in developed countries. The follow-up of high-risk young children must be reinforced in the Mexican population, as children with disabilities have high and sequential health-care needs and may usually be lost to follow-up. Neuroimaging of PVL was the more frequent finding by MRI in this population., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Autism spectrum disorders (ASDs) are a group of neurodevelopmental pathologies characterized by social and communication deficits, for which treatments are limited. Cell therapies, including intrathecal (IT) administration of bone marrow (BM) mononuclear cells (BM-MNC), improves symptoms in patients with ASD. Twenty-four patients diagnosed with ASD, according to the Diagnostic and Statistical Manual of Mental Disorders Text Revision Fourth Edition (DSM-IV-TR) criteria, were autologously treated with IT BM-MNC, and the clinical effect was evaluated using the Childhood Autism Rating Scale (CARS) on Days 30 (n=24) and 180 (n=14) post-treatment. IT BM-MNC improved clinical outcomes by Day 30 ( p =0.0039), and those benefits remained and were further accentuated by Day 180 post-treatment (n=14; p =<0.0001). Clinical benefit at Days 30 ( p =0.001; r= -0.51) and 180 ( p =0.01; r= -0.60) posttreatment positively correlated with the enrichment of a putative BM stem cell population expressing the cluster of differentiation 133+ (CD133+) surface marker., Competing Interests: DISCLOSURES: All authors are employees of Hospital Universitario “Dr. José Eleuterio González.”, (Copyright © 2022. Matrix Medical Communications. All rights reserved.)

Background: This systematic review was commissioned to identify new variables associated with transplant outcomes that are not currently collected by the Organ Procurement and Transplantation Network (OPTN)., Methods: We identified 81 unique studies including 1 193 410 patients with median follow-up of 36 months posttransplant, reporting 108 unique risk factors., Results: Most risk factors (104) were recipient related; few (4) were donor related. Most risk factors were judged to be practical and feasible to routinely collect. Relative association measures were small to moderate for most risk factors (ranging between 1.0 and 2.0). The strongest relative association measure for a heart transplant outcome with a risk factor was 8.6 (recipient with the previous Fontan operation), for a kidney transplant 2.8 (sickle cell nephropathy as primary cause of end-stage renal disease), for a liver transplant 14.3 (recipient serum ferritin >500 µg/L), and for a lung transplant 6.3 (Burkholderia cepacia complex infection for 1 y or less). OPTN may consider some of these 108 variables for future collection to enhance transplant research and clinical care., Conclusions: Evidence-based approaches can be used to determine variables collected in databases and registries. Several candidate variables have been identified for OPTN.

Background: This systematic review summarizes the benefits of treating blood pressure (BP) in individuals 65 years and older., Methods: We included randomized trials that evaluated BP-lowering medications or BP targets in individuals 65 years and older. Trials were selected and appraised by pairs of independent reviewers., Results: We included 19 trials (42,134 patients). In individuals 65 years or older, antihypertensive therapy was associated with a reduction in all-cause mortality [relative risk: 0.88 (95% CI: 0.81 to 0.94); high certainty evidence; mean follow-up 31 months], cardiovascular mortality, myocardial infarction, heart failure, stroke, and chronic kidney disease. Individuals 75 years or older had a significant reduction in the risk of all-cause and cardiovascular mortality, stroke, and heart failure. Strict systolic BP targets (<120 mm Hg and <130 mm Hg) were associated with a significant reduction in the risk of all-cause and cardiovascular mortality and heart failure, whereas more liberal systolic targets (<150 mm Hg and <160 mm Hg) were associated with lower risk of heart failure and stroke. Older adults with type 2 diabetes mellitus (DM) had lower risk of chronic kidney disease without a significant reduction in other outcomes. However, there was no significant difference in estimates (i.e., interaction) between those with and without DM., Conclusions: Individuals aged 65 years and older or 75 years and older who receive antihypertensive therapy have statistically significant reduction in the risk of all-cause and cardiovascular mortality, heart failure, and stroke. There was no statistically significant difference in estimates between those with and without DM., (Copyright © 2019 Endocrine Society.)

Background: The efficacy of lipid-lowering agents on patient-important outcomes in older individuals is unclear., Methods: We included randomized trials that enrolled individuals aged 65 years or older and that included at least 1 year of follow-up.Pairs of reviewers selected and appraised the trials., Results: We included 23 trials that enrolled 60,194 elderly patients. For primary prevention, statins reduced the risk of coronary artery disease [CAD; relative risk (RR): 0.79, 95% CI: 0.68 to 0.91] and myocardial infarction (MI; RR: 0.45, 95% CI: 0.31 to 0.66) but not all-cause or cardiovascular mortality or stroke. These effects were imprecise in patients with diabetes, but there was no significant interaction between diabetes status and the intervention effect. For secondary prevention, statins reduced all-cause mortality (RR: 0.80, 95% CI: 0.73 to 0.89), cardiovascular mortality (RR: 0.68, 95% CI: 0.58 to 0.79), CAD (RR: 0.68, 95% CI: 0.61 to 0.77), MI (RR: 0.68, 95% CI: 0.59 to 0.79), and revascularization (RR: 0.68, 95% CI: 0.61 to 0.77). Intensive (vs less-intensive) statin therapy reduced the risk of CAD and heart failure. Niacin did not reduce the risk of revascularization, and fibrates did not reduce the risk of stroke, cardiovascular mortality, or CAD., Conclusion: High-certainty evidence supports statin use for secondary prevention in older individuals. Evidence for primary prevention is less certain. Data in older individuals with diabetes are limited; however, no empirical evidence has shown a significant difference based on diabetes status., (Copyright © 2019 Endocrine Society.)

Background: Trustworthy (i.e. low risk of bias) randomized clinical trials (RCTs) play an important role in evidence-based decision making. We aimed to systematically assess the risk of bias of trials published in high-impact endocrinology journals., Methods: We searched the MEDLINE/PubMed database between 2014 and 2016 for phase 2-4 RCTs evaluating endocrine-related therapies. Reviewers working independently and in duplicate used the Cochrane Risk of Bias Tool (CCRBT) to determine the extent to which the methods reported protected the results of each RCT from bias., Results: We assessed 292 eligible RCTs, of which 40% (116) were judged to be at low risk, 43% (126) at moderate, and 17% (50) at high risk of bias. Blinding of outcome assessment was the least common domain reported 43% (125), while selective reporting of outcomes was the most common 97% (282). In multivariable analysis, RCTs with a parallel design (OR 2.4; 95% CI; 1.2-4.6) and funded by for-profit sources (OR 2.2; 95% CI; 1.3-3.6) were more likely to be at low risk of bias., Conclusions: Trustworthy evidence should ultimately shape care to improve the likelihood of desirable patient outcomes. Six out-of 10 RCTs published in top endocrine journals are at moderate/high-risk of bias. Improving this should be a priority in endocrine research., Competing Interests: The authors have declared that no competing interests exist.

Context: The efficacy and safety of testosterone replacement therapy (TRT) in hypogonadal men remain incompletely understood., Objective: To conduct a systematic review and meta-analysis of randomized clinical trials (RCT) to determine the effects of TRT on patient-important outcomes and adverse events in hypogonadal men., Data Sources: We searched Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Database of Systematic Reviews, Ovid Cochrane Central Register of Controlled Trials, and Scopus from inception to March 2th, 2017., Study Selection: RCTs that assessed the efficacy and adverse events of TRT of at least 12 weeks compared with placebo in adult men with hypogonadism, defined by morning testosterone ≤300 ng/dL and at least one symptom or sign of hypogonadism., Data Extraction: Reviewers working independently and in duplicate assessed the quality of the trials and collected data on patient characteristics, interventions, and outcomes., Data Synthesis: We found 11 publications, reporting on 4 eligible trials (including 1,779 patients) at low risk of bias. Compared to placebo, TRT was associated with a small but significant increase in sexual desire or libido [standardized mean difference (SMD): 0.17, 95% CI 0.01, 0.34] (n=1383), erectile function [SMD: 0.16, 95% CI 0.06, 0.27] (n=1344), and sexual satisfaction [SMD: 0.16, 95% CI 0.01, 0.31] (n=676), but had no effect on energy or mood. TRT was associated with an increased risk of developing erythrocytosis [relative risk: 8.14, 95% CI: 1.87, 35.40] (n=1579) compared to placebo, but had no significant effect on lower urinary tract symptoms (LUTS)., Conclusion: In hypogonadal men TRT improves sexual desire, erectile function, and sexual satisfaction, however it increases the risk of erythrocytosis.

Guidelines often use the term expert opinion (EO) to qualify recommendations. We sought to identify the rationale and evidence type in EO recommendations. We searched multiple databases and websites for contemporary guidelines published in the last decade that used the term EO. We identified 1106 references, of which 69 guidelines were included (2390 recommendations, of which 907 were qualified as EO). A rationale for using EO designation was not provided in most (91%) recommendations. The most commonly cited evidence type was extrapolated from studies that did not answer guideline question (40% from randomised trials, 38% from observational studies and 2% from case reports or series). Evidence extrapolated from populations that were different from those addressed in the guideline was found in 2.5% of EO recommendations. We judged 5.6% of EO recommendations as ones that could have been potentially labelled as good practice statements. None of the EO recommendations were explicitly described as being solely dependent on the clinical experience of the panel. The use of EO as a level of evidence in guidelines remains common. A rationale for such use is not explicitly provided in most instances. Most of the time, evidence labelled as EO was indirect evidence and occasionally was very low-quality evidence derived from case series. We posit that the explicit description of evidence type, as opposed to using the label EO, may add clarity and transparency and may ultimately improve uptake of recommendations., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objectives: In the care of patients with type 2 diabetes, self-management is emphasised and studied while theory and observations suggest that patients also benefit from social support. We sought to assess the effect of social network interventions on social support, glycaemic control and quality of life in patients with type 2 diabetes., Research Design and Methods: We searched Ovid MEDLINE, Ovid EBM Reviews, Cochrane Central Register of Controlled Trials, EMBASE, PsycINFO and CINAHL through April 2017 for randomised clinical trials (RCTs) of social network interventions in patients with type 2 diabetes. Reviewers working independently and in duplicate assessed eligibility and risk of bias, and extracted data from eligible RCTs. We pooled estimates using inverse variance random effects meta-analysis., Results: We found 19 eligible RCTs enrolling 2319 participants. Social network interventions were commonly based on individual behaviour change rather than social or interpersonal theories of self-management, were educational, and sought to engage social network members for their knowledge and experience. Interventions improved social support (0.74 SD (95% CI 0.32 to 1.15), I 2 =89%, 8 RCTs) and haemoglobin A1c at 3 months (-0.25 percentage points (95% CI -0.40 to -0.11), I 2 =12%, 9 RCTs), but not quality of life., Conclusions: Despite a compelling theoretical base, researchers have only minimally studied the value of interventions targeting patients' social networks on diabetes care. Although the body of evidence to date is limited, and based on individual behaviour change theories, the results are promising. This review challenges the scientific community to design and test theory-based interventions that go beyond self-management approaches to focus on the largely untapped potential of social networks to improve diabetes care., Prospero Registration: CRD42016036117., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)