Participants’ awareness of ethical compliance, safety and protection during participation in pharmaceutical industry clinical trials: a controlled survey

Background: The rapid increase of industry-sponsored clinical research towards developing countries has led to potentially complex ethical issues to assess. There is scarce evidence about the perception of these participants about the ethical compliance, security, and protection. We sought to evaluate and contrast the awareness and perception of participants and non-participants of industry-sponsored research trials (ISRT) on ethical, safety, and protection topics. Methods: A Cases-control survey conducted at twelve research sites in México. Previous and current participants of ISRT (cases) as well as non-participants (controls) with one of four chronic diseases, were asked to complete the survey which focused on ethical compliance and protection issues of ISRT, and the perception of participating in a trial. Results: A total of 604 cases and 604 controls were surveyed. Cases significantly answered that ethics committees are aware of what is happening in studies (50.5% vs. 33.8%, P=≤ 0.001), and that medical care of industry-sponsored research trials is better than their usual medical care (77.2% vs. 38.2%, P=<0.001).Thesameproportionofcasesand controls thought patients must receive economical reimbursement for participating in a research study (49.5% vs. 53.1%, P=0.205). The informed consent of the pharmaceutical clinical trial was fully read by 90.4% of the cases. Most cases were satisfied or very satisfied with their overall study participation (35.6 and 62.3%, respectively). Conclusion: Previous and current participants of industry-sponsored research trials have a more positive attitude towards ethics committees, the quality of medical care of the research trials, and the main purpose of economical reimbursements, when compared to non-participants. Keywords: Good clinical practices, Perception, Clinical trials, Pharmaceutical industry, Ethics committee

Participants' perception of pharmaceutical clinical research: a cross-sectional controlled study

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

Ovarian and Adrenal Androgens and Their Link to High Human Chorionic Gonadotropin Levels: A Prospective Controlled Study

Background. Although the association between human chorionic gonadotropin (hCG) and hyperandrogenism was identified more than 40 years ago, relevant questions remain unanswered. Design and Methods. We conducted a prospective, longitudinal, and controlled study in 23 women with a diagnosis of a complete hydatidiform mole (HM). Results. All participants completed the study. Before HM evacuation mean hCG was markedly higher in the cases than in the control group (P≤0.001). Free testosterone (T) and dehydroepiandrosterone sulfate (DHEA-S) were found to be higher in the cases (2.78 ± 1.24 pg/mL and 231.50 ± 127.20 μ/dL) when compared to the control group (1.50 ± 0.75 pg/mL and 133.59 ± 60.69 μ/dL) (P=0.0001 and 0.001), respectively. There was a strong correlation between hCG and free T/total T/DHEA-S concentrations (r=0.78; P≤0.001, r=0.74;  P≤0.001, and r=0.71;  P≤0.001), respectively. In the cases group 48 hours after HM evacuation, hCG levels were found to be significantly lower when compared to initial levels (P=0.001) and free T and DHEA-S declined significantly (P=0.0002 and 0.009). Conclusion. Before uterus evacuation, hCG, free T, and DHEA-S levels were significantly higher when compared with controls finding a strong correlation between hCG and free T/DHEA-S levels. Forty-eight hours after HM treatment hCG levels declined and the difference was lost. A novel finding of our study is that in cases, besides free T, DHEA-S was also found to be significantly higher and both the ovaries and adrenal glands appear to be the sites of this androgen overproduction

Trustworthiness of randomized trials in endocrinology—A systematic survey

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 researc

Asociación de tipología familiar y disfuncionalidad en familias con adolescentes de una población mexicana

AdolescenteResumenObjetivo: Determinar la asociación entre tipología y disfuncionalidad familiar en familias mexi-canas con adolescentes.Dise˜no: Estudio observacional de tipo transversal.Emplazamiento y participantes: Cuatrocientas treinta y siete familias con adolescentes inscri-tos en una escuela secundaria pública de una población mexicana.Mediciones principales: Determinación de la tipología familiar (Consejo y Consenso Mexicanode Medicina Familiar) y la funcionalidad familiar (APGAR familiar) en adolescentes y suspadres/tutores. Identificación de las familias con percepciones concordantes entre miembros(kappa de Cohen), en las cuales se determinó la asociación entre tipología y percepción dedisfuncionalidad familiar (odds ratio [OR]).Resultados: Los tipos de familias están asociados con la funcionalidad familiar por parentesco,presencia física en el hogar y el nivel de pobreza familiar. Desde la percepción del adolescente,se asocian los tipos: nuclear simple (OR 0,5, IC 95% 0,3-0,8), monoparental extendida (OR 1,9,IC 95% 1,03-3,5), núcleo integrado (OR 0,6, IC 95% 0,4-0,9), pobreza familiar baja (OR 0,5, IC95% 0,3-0,8) y pobreza familiar alta (OR 5,3, IC 95% 1,5-18,6). Desde la percepción del tutor:la monoparental (OR 1,9, IC 95% 1,09-3,4) y de pobreza familiar alta (OR 2 9, IC 95% 1,1-7,7).Hubo 259 familias con percepción concordante de funcionalidad/disfuncionalidad familiar conun � = 0,189, determinando que los tipos asociados son: la nuclear simple (OR 0,4, IC 95% 0,2-0,7), monoparental (OR 1,7, IC 95% 0,80-3,8), núcleo integrado (OR 0,5, IC 95% 0,3-0,8), núcleono integrado (OR 1,9, IC 95% 1,09-3,5) y pobreza familiar alta (OR 13,8, IC 95% 1,7-108,5). Conclusión: Los tipos de familia con adolescentes asociadas con disfuncionalidad familiar sonlas monoparentales, las de núcleo no integrado y aquellas con pobreza familiar alta, y comofactores de protección, la nuclear simple y con núcleo integrado

Values, preferences and burden of treatment for the initiation of GLP-1 receptor agonists and SGLT-2 inhibitors in adult patients with type 2 diabetes: a systematic review

Objectives Assess values, preferences and burden of treatment that patients with type 2 diabetes consider when initiating glucagon-like peptide-1 receptor agonists (GLP-1 RA) or sodium-glucose cotransporter-2 inhibitors (SGLT-2i) compared with other glucose-lowering options.Methods Paired reviewers independently included studies reporting quantitative or qualitative methods to assess values, preferences and burden of treatment reported by patients with type 2 diabetes regarding the initiation of GLP-1 RA or SGLT-2i over other alternatives. A systematic search in MEDLINE, Scopus, EMBASE, Web of Science and Cochrane Central Register of Controlled Trials from inception until May 2020 was performed by an experienced librarian. Risk of bias was assessed with a specifically designed tool for values and preferences studies.Results 17 studies (7296 patients) proved eligible. Studies fulfilling criteria for SGLT-2i were not identified. Five studies (2662 patients) evaluated preferences for GLP-1 RA compared with other glucose-lowering medications. 12 studies (4634 patients) evaluated preferences between, at least, two kinds of GLP-1 RA or their injection devices based on the following attributes: efficacy, dose, application frequency, device characteristics. Among studies comparing GLP-1 RA to other glucose-lowering medications, some preferences were observed for dypeptil peptidase-4 inhibitors compared with once daily liraglutide. Comparing different attributes of GLP-1 RA drugs and devices, cardiovascular risk reduction, glucose lowering potential, once weekly and simple administered regimens were the most preferred.Conclusions As no evidence for preferences on SGLT-2i was available, only preferences for GLP-1 RA were assessed; however, evidence is still limited for the latter. Studies comparing preferences for GLP1-RA to other glucose-lowering alternatives only included twice daily or once daily injection regimens of GLP-1 RA drugs. According to our findings, once weekly alternatives are widely preferred than the formers. The extent to which patients with type 2 diabetes value reduced adverse cardiovascular and kidney outcomes, weighed benefits against harms and burden of treatment is limited and with very low certainty

Predictors of the length of stay of psychiatric inpatients: protocol for a systematic review and meta-analysis

Background Length of stay (LOS) for inpatient psychiatric services is an important factor with serious drawbacks when it is extended more than needed. Impacts on economy, social functioning, and stigma can hamper improvement and affect the patients’ experiences on future mental healthcare. Predictions of which patients have a higher chance for prolonged LOS have been extensively researched. Previous systematic reviews found consistent predictors of both longer and shorter LOS. However, they do not provide an estimate from the pooled effect sizes. Furthermore, to our knowledge, there is no meta-analysis on the influence of these factors. The primary objective of this study will be to provide point estimates on the effect sizes of all studied predictors of the LOS of psychiatric inpatients. Methods We will conduct a systematic search in PubMed, MEDLINE, EMBASE, and PsycINFO for observational studies evaluating the effect size of independent factors on the length of stay of psychiatric inpatients. Prospective and retrospective cohorts that assess the influence of predictors through the reporting of standardized regression coefficients will be included. We will provide a qualitative synthesis of the findings from each study and perform a meta-analysis from pooled regression coefficients that were adjusted for other variables or confounders in order to obtain a point estimate and confidence interval for all factors extracted from the included studies. Discussion The results from this study may provide more accurate predictions for mental health institutions, psychiatrists, mental health service providers, patients, and families on the prognosis regarding the length of stay for needed inpatient care. This information may be used to anticipate individuals with a higher chance for prolonged hospitalization to plan the necessary interventions for these specific situations. Considering both the benefits and disadvantages of longer and shorter stays, the pooled estimates for independent factors may be used by mental healthcare providers and patients for informed decision-making. The results from this study will also update results presented in previous studies and identify the strengths and limitations from the current available evidence

Ovarian and Adrenal Androgens and Their Link to High Human Chorionic Gonadotropin Levels: A Prospective Controlled Study

Background. Although the association between human chorionic gonadotropin (hCG) and hyperandrogenism was identified more than 40 years ago, relevant questions remain unanswered. Design and Methods. We conducted a prospective, longitudinal, and controlled study in 23 women with a diagnosis of a complete hydatidiform mole (HM). Results. All participants completed the study. Before HM evacuation mean hCG was markedly higher in the cases than in the control group ( ≤ 0.001). Free testosterone (T) and dehydroepiandrosterone sulfate (DHEA-S) were found to be higher in the cases (2.78 ± 1.24 pg/mL and 231.50 ± 127.20 /dL) when compared to the control group (1.50 ± 0.75 pg/mL and 133.59 ± 60.69 /dL) ( = 0.0001 and 0.001), respectively. There was a strong correlation between hCG and free T/total T/DHEA-S concentrations ( = 0.78; ≤ 0.001, = 0.74; ≤ 0.001, and = 0.71; ≤ 0.001), respectively. In the cases group 48 hours after HM evacuation, hCG levels were found to be significantly lower when compared to initial levels ( = 0.001) and free T and DHEA-S declined significantly ( = 0.0002 and 0.009)

Economic impact of Juvenile Idiopathic Arthritis: a systematic review

Abstract Background Juvenile Idiopathic Arthritis (JIA) requires complex care that generate elevated costs, which results in a high economic impact for the family. The aim of this systematic review was to collect and cluster the information currently available on healthcare costs associated with JIA after the introduction of biological therapies. Methods We comprehensively searched in MEDLINE, EMBASE, Web of Science, Scopus, and Cochrane Databases for studies from January 2000 to March 2021. Reviewers working independently and in duplicate appraised the quality and included primary studies that report total, direct and/or indirect costs related to JIA for at least one year. The costs were converted to United States dollars and an inflationary adjustment was made. Results We found 18 eligible studies including data from 6,540 patients. Total costs were reported in 10 articles, ranging from $310 USD to$44,832 USD annually. Direct costs were reported in 16 articles ($193 USD to$32,446 USD), showing a proportion of 55 to 98 % of total costs. Those costs were mostly related to medications and medical appointments. Six studies reported indirect costs ($117 USD to$12,385 USD). Four studies reported costs according to JIA category observing the highest in polyarticular JIA. Total and direct costs increased up to three times after biological therapy initiation. A high risk of reporting bias and inconsistency of the methodology used were found. Conclusion The costs of JIA are substantial, and the highest are derived from medication and medical appointments. Indirect costs of JIA are underrepresented in costs analysis