LEGAL RESPONSIBILITY PRESCRIBING OFF-LABEL DRUGS: IS SPAIN DIFFERENT?

– In Spain the compassionate use and off-label prescription, are both regulated in the same law: the Royal Decree 1015/2009. This norm facilitates the access to drugs in specific clinical situations, similar to US regulation and in a different way to the UE regulation.– It is a legal practice to prescribe in an off-label manner if the following requirements are followed: there are no authorized therapeutic alternatives, prescribed in health centers, when access to these drugs is provided through a protocol of use after justifying (written) and properly informing (verbal) and obtaining the patient's consent.– When prescribing off-label the doctor's decision is based on contrasted scientific evidence (not merely on personal intuition nor personal experience). In fact, this anticipates an eventual update of the data sheet for new indications or populations, unlike the French situation where they have the ATU (Temporary Utilization Authorization).– In Spain the holder of the Marketing Authorization is obliged not to promote or advertise the use of the drug in different conditions to those approved (unlike the USA regulation).– The jurisprudential analysis from the Spanish Courts states that the doctor's responsibility is equal than that concerning on-label prescription, that is, only in the case of bad medical praxis (as in the USA). The most important cause of sentencing were: the lack of informed consent, lack of control of the medication and lack of correct follow-up of the illness, whereas this does not include the drug, dose, duration or even the patient's age.– In European Union the general rule dictated by the Courts is to permit off-label use if this is according to the best medical practice (lex artis ad hoc). Even more, there are some specific cases (in Germany, like in the USA) where it is possible to generate doctor's responsibility for no prescribing in a off-label manner.

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“A debriefer must be neutral” and other debriefing myths: a systemic inquiry-based qualitative study of taken-for-granted beliefs about clinical post-event debriefing

Advances in Simulation ◽

10.1186/s41077-021-00161-5 ◽

2021 ◽

Vol 6 (1) ◽

Author(s):

Julia Carolin Seelandt ◽

Katie Walker ◽

Michaela Kolbe

Keyword(s):

Interpersonal Relationships ◽

Western Europe ◽

Ad Hoc ◽

Scientific Evidence ◽

Clinical Event ◽

Clinical Settings ◽

Healthcare Organizations ◽

The Usa ◽

Open Coding ◽

Healthcare Administrators

Abstract Background The goal of this study was to identify taken-for-granted beliefs and assumptions about use, costs, and facilitation of post-event debriefing. These myths prevent the ubiquitous uptake of post-event debriefing in clinical units, and therefore the identification of process, teamwork, and latent safety threats that lead to medical error. By naming these false barriers and assumptions, the authors believe that clinical event debriefing can be implemented more broadly. Methods We interviewed an international sample of 37 clinicians, educators, scholars, researchers, and healthcare administrators from hospitals, universities, and healthcare organizations in Western Europe and the USA, who had a broad range of debriefing experience. We adopted a systemic-constructivist approach that aimed at exploring in-depth assumptions about debriefing beyond obvious constraints such as time and logistics and focused on interpersonal relationships within organizations. Using circular questions, we intended to uncover new and tacit knowledge about barriers and facilitators of regular clinical debriefings. All interviews were transcribed and analyzed following a comprehensive process of inductive open coding. Results In total, 1508.62 min of interviews (25 h, 9 min, and 2 s) were analyzed, and 1591 answers were categorized. Many implicit debriefing theories reflected current scientific evidence, particularly with respect to debriefing value and topics, the complexity and difficulty of facilitation, the importance of structuring the debriefing and engaging in reflective practice to advance debriefing skills. We also identified four debriefing myths which may prevent post-event debriefing from being implemented in clinical units. Conclusion The debriefing myths include (1) debriefing only when disaster strikes, (2) debriefing is a luxury, (3) senior clinicians should determine debriefing content, and (4) debriefers must be neutral and nonjudgmental. These myths offer valuable insights into why current debriefing practices are ad hoc and not embedded into daily unit practices. They may help ignite a renewed momentum into the implementation of post-event debriefing in clinical settings.

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Treatment of varicose tributaries with sclerotherapy with polidocanol 0.5 % foam

VASA ◽

10.1024/0301-1526/a000023 ◽

2010 ◽

Vol 39 (2) ◽

pp. 169-174 ◽

Cited By ~ 7

Author(s):

Reich-Schupke ◽

Weyer ◽

Altmeyer ◽

Stücker

Keyword(s):

Scientific Evidence ◽

Daily Practice ◽

Severe Adverse Effect ◽

Safe Procedure ◽

Efficacy And Safety ◽

Foam Sclerotherapy ◽

History Of ◽

One Year ◽

Additional Therapy

Background: Although foam sclerotherapy of varicose tributaries is common in daily practice, scientific evidence for the optimal sclerosant-concentration and session-frequency is still low. This study aimed to increase the knowledge on foam sclerotherapy of varicose tributaries and to evaluate the efficacy and safety of foam sclerotherapy with 0.5 % polidocanol in tributaries with 3-6 mm in diameter. Patients and methods: Analysis of 110 legs in 76 patients. Injections were given every second or third day. A maximum of 1 injection / leg and a volume of 2ml / injection were administered per session. Controls were performed approximately 6 months and 12 months after the start of therapy. Results: 110 legs (CEAP C2-C4) were followed up for a period of 14.2 ± 4.2 months. Reflux was eliminated after 3.4 ± 2.7 injections per leg. Insufficient tributaries were detected in 23.2 % after 6.2 ± 0.9 months and in 48.2 % after 14.2 ± 4.2 months, respectively. Only 30.9 % (34 / 110) of the legs required additional therapy. In 6.4 % vein surgery was performed, in 24.5 % similar sclerotherapy was repeated. Significantly fewer sclerotherapy-sessions were required compared to the initial treatment (mean: 2.3 ± 1.4, p = 0.0054). During the whole study period thrombophlebitis (8.2 %), hyperpigmentation (14.5 %), induration in the treated region (9.1 %), pain in the treated leg (7.3 %) and migraine (0.9 %) occurred. One patient with a history of thrombosis developed thrombosis of a muscle vein (0.9 %). After one year there were just hyperpigmentation (8.2 %) and induration (1.8 %) left. No severe adverse effect occurred. Conclusions: Foam sclerotherapy with injections of 0.5 % polidocanol every 2nd or 3rd day, is a safe procedure for varicose tributaries. The evaluation of efficacy is difficult, as it can hardly be said whether the detected tributaries in the controls are recurrent veins or have recently developed in the follow-up period. The low number of retreated legs indicates a high efficacy and satisfaction of the patients.

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The Language of New Terrorism: Differences in Psychological Dimensions of Communication in Dabiq and Inspire

10.31234/osf.io/xg4f3 ◽

2017 ◽

Author(s):

Matteo Vergani ◽

Ana-Maria Bliuc

Keyword(s):

Experimental Study ◽

English Language ◽

Terrorist Attacks ◽

Al Qaeda ◽

Positive Attitudes ◽

Terrorist Groups ◽

The Usa ◽

Psychological Dimensions ◽

New Terrorism

We investigate differences in the psychological aspects underpinning Western mobilisation of two terrorist groups by analysing their English-language propaganda. Based on a computerized analysis of the language used in two English-language online magazines circulated by ISIS and al-Qaeda (i.e., Dabiq and Inspire), we found significant differences in their language - the ISIS’ language being higher in authoritarianism and its level of religiousness. In a follow-up experimental study, we found that being high in religiousness and authoritarianism predicts more positive attitudes towards the language used by ISIS, but not towards the language used by al-Qaeda. The results suggest that ISIS’ propaganda may be more effective in mobilising individuals who are more authoritarian and more focused on religion than that of al-Qaeda. These findings are consistent with the behaviour observed in recent homegrown terrorist attacks in the USA and Europe.

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Faculty Opinions recommendation of Work-related asthma in the USA: nationally representative estimates with extended follow-up.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.737953984.793575027 ◽

2020 ◽

Author(s):

Sherwood Burge

Keyword(s):

Work Related ◽

The Usa ◽

Nationally Representative

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Topical Analgesic Formulations: Following the Transdermal Treatment Paradigm Only?

Journal of Clinical and Medical Research ◽

10.37191/mapsci-2582-4333-1(3)-017 ◽

2019 ◽

Author(s):

Jan M Keppel Hesselink

Keyword(s):

Ad Hoc ◽

Active Pharmaceutical Ingredient ◽

Mechanisms Of Action ◽

Onset Of Action ◽

Good Tolerability ◽

Short Commentary ◽

Topical Analgesics ◽

The Usa ◽

Treatment Paradigm ◽

Topical Analgesic

Topical analgesics are regarded as new inroads to treat peripheral neuropathic pain, with a number of advantages over oral treatments. Topical treatment reduces systemic induced side-effects and have good tolerability, without problems of misuse or abuse, or dependency. Furthermore, the onset of action is fast, mostly within 30 minutes. The mechanism of action of topical analgesics is either via transdermal delivery of the analgesic, or via intradermal mechanisms of action. In the latter case, plasma levels of analgesics in the blood are absent or very low. This perspective is missing in the approach of the ad hoc committee of the National Academies of Sciences, Engineering, and Medicine in the USA, installed by the FDA. In this short commentary, we plead for a more comprehensive approach of topical analgesics, including those formulations which explicitly are not based on transdermal penetration of the active pharmaceutical ingredient, but on intradermal mechanisms of action.

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Feasibility of using a biofeedback device in mindfulness training - a pilot randomized controlled trial

Pilot and Feasibility Studies ◽

10.1186/s40814-021-00807-1 ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Brenna Lin ◽

Christopher Prickett ◽

Steven Woltering

Keyword(s):

College Students ◽

Mindfulness Meditation ◽

Controlled Trial ◽

Scientific Evidence ◽

Well Being ◽

Open Science ◽

Control Group ◽

Test Procedures ◽

The Usa ◽

Biofeedback Device

Abstract Background Stress can negatively impact an individual’s health and well-being and high levels of stress are noted to exist among college students today. While traditional treatment methods are plagued with stigma and transfer problems, newly developed wearable biofeedback devices may offer unexplored possibilities. Although these products are becoming commonplace and inexpensive, scientific evidence of the effectiveness of these products is scarce and their feasibility within research contexts are relatively unexplored. Conversely, companies are not required, and possibly reluctant, to release information on the efficacy of these products against their claims. Thus, in the present pilot, we assess the feasibility of using a real-time respiratory-based biofeedback device in preparation for a larger study. Our main aims were to assess device-adherence and collaboration with the company that develops and sells the device. Method Data were collected from 39 college students who self-identified as experiencing chronic stress at a Southwestern university in the USA. Students were randomized into either a mindfulness-only control group without a biofeedback device (n = 21), or an experimental group with biofeedback device (n = 18). Both groups received mindfulness meditation training. Pre-test and post-test procedures were conducted 2 weeks apart. Further, both participant compliance and company compliance were assessed and collaboration with the company was evaluated. Results Participant device-adherence as well as the company’s collaboration necessary for a full-scale study was determined to be low. This may also have affected our results which showed a strong main effect for time for all outcome variables, suggesting all groups showed improvement in their levels of stress after the intervention period. No group by time effects were identified, however, indicating no added benefit of the biofeedback device. Conclusions Our findings suggest feasibility of future studies requires full collaboration and detailed and agreed upon data sharing procedures with the biofeedback company. The particular device under investigation added no value to the intervention outcomes and it was not feasible to continue a larger-scale study. Further, as the technology sector is innovating faster than it can validate products, we urge for open science collaborations between public and private sectors to properly develop evidence-based regulations that can withstand technological innovation while maintaining product quality, safety, and effectiveness. Trial registration NCT02837016. Registered 19 July 2016.

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Maternal age at birth and daughter’s fecundability

Human Reproduction ◽

10.1093/humrep/deab057 ◽

2021 ◽

Author(s):

Olga Basso ◽

Sydney K Willis ◽

Elizabeth E Hatch ◽

Ellen M Mikkelsen ◽

Kenneth J Rothman ◽

...

Keyword(s):

Risk Factors ◽

Cohort Study ◽

Maternal Age ◽

Limited Information ◽

Loss To Follow Up ◽

Older Mothers ◽

Registration Number ◽

The Usa ◽

Competing Interest

Abstract STUDY QUESTION Do daughters of older mothers have lower fecundability? SUMMARY ANSWER In this cohort study of North American pregnancy planners, there was virtually no association between maternal age ≥35 years and daughters’ fecundability. WHAT IS KNOWN ALREADY Despite suggestive evidence that daughters of older mothers may have lower fertility, only three retrospective studies have examined the association between maternal age and daughter’s fecundability. STUDY DESIGN, SIZE, DURATION Prospective cohort study of 6689 pregnancy planners enrolled between March 2016 and January 2020. PARTICIPANTS/MATERIALS, SETTING, METHODS Pregnancy Study Online (PRESTO) is an ongoing pre-conception cohort study of pregnancy planners (age, 21-45 years) from the USA and Canada. We estimated fecundability ratios (FR) for maternal age at the participant’s birth using multivariable proportional probabilities regression models. MAIN RESULTS AND THE ROLE OF CHANCE Daughters of mothers ≥30 years were less likely to have previous pregnancies (or pregnancy attempts) or risk factors for infertility, although they were more likely to report that their mother had experienced problems conceiving. The proportion of participants with prior unplanned pregnancies, a birth before age 21, ≥3 cycles of attempt at study entry or no follow-up was greater among daughters of mothers <25 years. Compared with maternal age 25–29 years, FRs (95% CI) for maternal age <20, 20–24, 30–34, and ≥35 were 0.72 (0.61, 0.84), 0.92 (0.85, 1.00), 1.08 (1.00, 1.17), and 1.00 (0.89, 1.12), respectively. LIMITATIONS, REASONS FOR CAUTION Although the examined covariates did not meaningfully affect the associations, we had limited information on the participants’ mother. Differences by maternal age in reproductive history, infertility risk factors and loss to follow-up suggest that selection bias may partly explain our results. WIDER IMPLICATIONS OF THE FINDINGS Our finding that maternal age 35 years or older was not associated with daughter’s fecundability is reassuring, considering the trend towards delayed childbirth. However, having been born to a young mother may be a marker of low fecundability among pregnancy planners. STUDY FUNDING/COMPETING INTEREST(S) PRESTO was funded by NICHD Grants (R21-HD072326 and R01-HD086742) and has received in-kind donations from Swiss Precision Diagnostics, FertilityFriend.com, Kindara.com, and Sandstone Diagnostics. Dr Wise is a fibroid consultant for AbbVie, Inc. TRIAL REGISTRATION NUMBER n/a

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Promoting Interpersonal Relationships through Elbow Tag, a Traditional Sporting Game. A Multidimensional Approach

Sustainability ◽

10.3390/su13147887 ◽

2021 ◽

Vol 13 (14) ◽

pp. 7887

Author(s):

Verónica Muñoz-Arroyave ◽

Miguel Pic ◽

Rafael Luchoro-Parrilla ◽

Jorge Serna ◽

Cristòfol Salas-Santandreu ◽

...

Keyword(s):

Decision Making ◽

Social Interactions ◽

Interpersonal Relationships ◽

Predictive Power ◽

Ad Hoc ◽

Scientific Evidence ◽

Point Of View ◽

Registration System ◽

Motor Behaviors ◽

Quasi Experimental

The aim of this research was to study from a multidimensional point of view (decisional, relational and energetic) the interpersonal relationships established by girls and boys in the traditional sport game of Elbow Tag. Scientific evidence has shown that Traditional Sport Games (TSG) trigger different effects on male and female genders in relation to emotional experiences, decision-making, conflicts and motor relationships. Despite the fact that these dimensions are intertwined, there are hardly any studies that interpret motor behaviors holistically, i.e., taking a multidimensional (360°) view of these dimensions. For this study, a quasi-experimental design was used and a type III design was applied, inspired by the observational methodology N/P/M. A total of 147 university students participated (M = 19.6, SD = 2.3): 47 girls (31.97%) and 100 boys (68.02%). A mixed ‘ad hoc’ registration system was designed with acceptable margins of data quality. Cross-tabulations, classification trees and T-patterns analysis were applied. The results indicated that social interactions between girls and boys in a mixed group were unequal. This difference was mainly due to decision-making (sub-role variable), which has much greater predictive power than the energetic variables (MV and steps).

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