Anxiety and Academic Performance based on the school average, in Students of the Faculty of Psychology and Human Communication Therapy (FPYTCH) of the Juárez University of the State of Durango

In undergraduate students, it is not uncommon to hear that they have symptoms of anxiety, due to the workload they have. Objectives: Identify the presence of anxiety in FPyTCH students, Indicate if academic performance is affected with respect to anxiety in FPyTCH students. Methodology: This research was non-experimental, exploratory, observational, by survey, cross-sectional and descriptive, since no experimental maneuver was performed, in a non-probabilistic sample obtained by accident and convenience, after signing the informed consent. Procedure: 104 students participated corresponding to the semesters of 1st, 2nd, 3rd, 4th and 5th, to who were administered the Beck anxiety questionnaire. For statistical processing, spss version 20.0 software was used. Contribution: .906 CRONBACH. The results obtained show that 28.8% of the students present severe anxiety and 13.5% do not have anxiety, as well as the minimum grade average found is 6.9 and the maximum is 9.7, however, said grade average is not found. influenced by the presence or not of anxiety.

Deferred Consent in an Acute Stroke Trial from a Patient, Proxy, and Physician Perspective: A Cross-Sectional Survey

Background In some acute care trials, immediate informed consent is not possible, but deferred consent is often considered problematic. We investigated the opinions of patients, proxies, and physicians about deferred consent in an acute stroke trial to gain insight into its acceptability and effects. Methods Paper-based surveys were sent to patients who were randomly assigned in the Ultra-early Tranexamic Acid After Subarachnoid Hemorrhage (ULTRA) trial between 2015 and 2018 in two tertiary referral centers and to physicians of centers who agreed or declined to participate. The primary outcome measure was the proportion of respondents who agreed with deferral of consent in the ULTRA trial. Secondary outcomes included respondents’ preferred consent procedure for the ULTRA trial, the effect of deferred consent on trust in physicians and scientific research, and the willingness to participate in future research. Results Eighty-nine of 135 (66%) patients or proxies and 20 of 30 (67%) physicians completed the survey. Of these, 82 of 89 (92%) patients or proxies and 14 of 20 (70%) physicians agreed with deferral of consent in the ULTRA trial. When asked for their preferred consent procedure for the ULTRA trial, 31 of 89 (35%) patients or proxies indicated deferred consent, 15 of 89 (17%) preferred immediate informed consent, and 32 of 89 (36%) had no preference. None of the patients’ or proxies’ trust in physicians or scientific research had decreased because of the deferred consent procedure. Willingness to participate in future studies remained the same or increased in 84 of 89 (94%) patients or proxies. Conclusions A large majority of the surveyed patients and proxies and a somewhat smaller majority of the surveyed physicians agreed with deferred consent in the ULTRA trial. Deferred consent may enable acute care trials in an acceptable manner without decreasing trust in medicine. Future research should investigate factors facilitating the responsible use of deferred consent, such as in-depth interviews, to study the minority of participants who agreed with deferred consent but still preferred immediate informed consent.

Volunteers for clinical trials: from the history of abuses and exploitation to the inclusion movement, and to an income resource

Medical research is essential to develop new and better therapies, increase social standards and a better life for all of us. Scientific curiosity has helped to achieve many successful innovations, but history also demonstrates that research can lead to abuses of individuals neglecting autonomy and integrity of the human being. Since the 1960ies we have witnessed a continuous development of international regulations and ethics guidelines (soft law) in medical research, leading to a higher quality of scientific results. An important focus lies on recognizing human vulnerability and a therefore adapted informed consent procedure. Our modern clinical trials structure requires the inclusion of healthy volunteers in the first phases of the development of a new medicinal product, leading to new ethical questions and challenges. The Corona-Pandemic has accelerated vaccine development in a successful way also leading to a new importance of healthy volunteers in the medical research landscape.

Practice variation in the informed consent procedure for thrombolysis in acute ischemic stroke: a survey among neurologists and neurology residents

Background Obtaining informed consent for intravenous thrombolysis in acute ischemic stroke can be challenging, and little is known about if and how the informed consent procedure is performed by neurologists in clinical practice. This study examines the procedure of informed consent for intravenous thrombolysis in acute ischemic stroke in high-volume stroke centers in the Netherlands. Methods In four high volume stroke centers, neurology residents and attending neurologists received an online questionnaire concerning informed consent for thrombolysis with tissue-type plasminogen activator (tPA). The respondents were asked to report their usual informed consent practice for tPA treatment and their considerations on whether informed consent should be obtained. Results From the 203 invited clinicians, 50% (n = 101) completed the questionnaire. One-third of the neurology residents (n = 21) and 21% of the neurologists (n = 8) reported that they always obtain informed consent for tPA treatment. If a patient is not capable of providing informed consent, 30% of the residents (n = 19) reported that they start tPA treatment without informed consent. In these circumstances, 53% of the neurologists (n = 20) reported that the resident under their supervision would start tPA treatment without informed consent. Most neurologists (n = 21; 55%) and neurology residents (n = 45; 72%) obtained informed consent within one minute. None of the respondents used more than five minutes for informed consent. Important themes regarding obtaining informed consent for treatment were patients’ capacity, and medical, ethical and legal considerations. Conclusion The current practice of informed consent for thrombolysis in acute ischemic stroke varies among neurologists and neurology residents. If informed consent is obtained, most clinicians stated to obtain informed consent within one minute. In the future, a shortened information provision process may be applied, making a shift from informed consent to informed refusal, while still considering the patient’s capacity, stroke severity, and possible treatment delays.

EXPRESS: Factors influencing the use of different methods of consent in a randomised acute stroke trial, the Third International Stroke Trial (IST-3)

Background Obtaining informed consent in people with acute stroke is complex since many, as a direct result of their stroke, lose capacity to make important decisions. Furthermore reperfusion interventions are time dependent necessitating rapid consent. We developed 4 different consent approaches to facilitate recruitment of a broad range of patients in the Third International Stroke Trial (IST-3). Aims To describe the clinical characteristics of patients recruited by different consent methods and the association between these methods and time from stroke onset to randomisation. Methods IST-3 was a randomised controlled trial of thrombolysis for acute ischaemic stroke. Clinicians could use one of four consent procedures: written consent, witnessed consent, assent, or a waiver of consent. We analysed the relationship between consent procedure and baseline variables. The effect of consent procedure on delay time from onset to randomisation was determined using analysis of variance to adjust for confounding effects. Results Of the 3035 patients recruited, the method of consent was known for 3034 (99.9%) and it was: written in 985 subjects (24%), witnessed verbal consent in 280 (9.2%), assent by relative in 1727 (56.9%), and waiver of consent in 42 subjects (1.4%). Assent was required in 63.4% for those presenting 0-3 hours from stroke onset (written consent in 25.3%). Patients with more severe neurological deficits (or with a non-lacunar hemispheric stroke syndrome) were less likely to give written consent. Mean delay between onset and randomisation varied significantly between consent types (one way anova : F=15.7 on 3 df, P<0.0001) (longest at 4.06 hours for signed consent and 3.46 hours for waiver of consent). Conclusions Acute stroke trials requiring written informed consent would result in substantial selection bias. Flexible consent methods will ensure a broad range of patients are recruited, enabling trial results to be widely generalisable. Registration The study is registered number ISRCTN25765518. Data access statement IST-3 Trial dataset is available on Edinburgh Data Share. https://datashare.ed.ac.uk/handle/10283/1931

Intention, perception and trust: Comment on “Challenges of informed consent during a political crisis” by Mishra and Gaitonde

This note explores the relevance of the ethics requirement of having a “study­independent observer/impartial witness” signing off on the informed consent procedure when the community under study is unwilling to do so. It shows how the community's distrust of the researcher as an agent of a malevolent government (expressed in a refusal to sign the consent form) is reflected in the researcher's objective links to government through education and advanced academic research. The note argues that research ethics, rather than blindly following rules, means thinking about context. It reverses the question of relevance of the ethics protocol, to questioning the relevance of the research to the community. It suggests that thinking this through will clarify the position of the researcher and contribute to research ethics

Buffering Effect of in-patient Psychiatric Care on the Link Between Fear of Covid-19 and Mental Health Consequences

Background& AimesPsychiatric admissions during the covid-19 pandemic were limited ignoring their possible benefit. The study focused on assessing the effect of the fear of covid on the mental health and well-being of in-patients as opposed to outpatients MethodsDuring the first lockdown, forty-four in-patients and day care patients (in-patient group) and 74 outpatients (out-patient group) were recruited after an informed consent procedure. Fear from the infection was assed using the Fear of COVID-19 (FCV-19S), severity of mental health symptomatology was evaluated with the outcome questionnaire-45 (OQ-45)., wellbeing was assessed with the Psychological well-being scale (PWB).OutcomesThere was no difference between the in-patient group and out-patient group in their fear of COVID-19 levels. FCV-19 predicted changes in the outpatient OQ total score (B=2.21, p<0.001), OQ interpersonal relation subscale (B=0.34, p=0.01), PWB total score (B=-0.05, p<0.001), PWB environmental mastery subscale (B=-.07, p<0.001) and PWB positive relation subscale (B=-0.05, p<0.001), but not in the inpatient group.ConclusionsMental health and well-being of the out-patient group that had less therapeutic contact –unlike the in-patient group-correlated with the fear of covid. Supporting the hypothesis that intensive psychiatric therapy had a protective effect from the mental health consequences of “fear of covid”.