Originalarbeiten / Original Articles. Entwicklung und Evaluation einer Aufklärungsbroschüre zu Ängsten und Angststörungen für Jugendliche.

Development and Evaluation of an Information Brochure on Anxiety and Anxiety Disorders for Adolescents Low mental health literacy and fear of being stigmatized are two main barriers that detain adolescents fromseeking professional help. An information brochure about anxiety disorders for adolescents was developed. To make a first statement about the quality of the brochure, 19 experts, consisting of (child and adolescents) psychotherapists, psychiatrists, and psychologists, rated a first version of the brochure regarding content validity and age-appropriatness. To evaluate the efficacy in knowledge and the acceptance of the brochure, a revised version was evaluated by N = 174 adolscents (106 female-, 66 male- and two non-binary) between 14 and 17 years of age (M = 16.56 years.; SD = 0.57).The experts' approval of all content items totals a mean average of 95.2 % (range: 84.2-100 %). In the adolescent sample, the intervention increased knowledge about anxiety disorders (d = 1.04) and improved attitudes about coping strategies (d = 0.99). Results of the experts' rating showed that content validity of the brochure can be assumed.The revised brochure seems to be a useful and effective tool to inform adolescents about anxiety disorders.

Use of Informational Brochures on Knowledge of Cataracts in Rural Ecuador.

Background Cataracts are the leading global cause of preventable blindness. Despite the high prevalence of cataracts in rural Ecuadorian communities, no community-wide educational efforts on the impact of cataract-related blindness have been attempted. This study used an educational brochure to assess individual knowledge of cataract blindness before and after the distribution of the brochure. Methods We conducted electronic surveys with 100 patients over the age of 18 who visited the Fundacion Internacional Buen Samaritano Paul Martel (FIBUSPAM) clinic serving the Chimborazo region of Ecuador. Participation in the study included an introduction and written consent followed by a pre-survey. Every patient was given a brochure. After reviewing the brochure, patients were then asked to complete the same survey again. Each survey question received one mark. Knowledge was considered "good" if the subject correctly answered four out of seven questions and "poor" if they scored ≤3. Results Of the 100 patients, 21 had poor knowledge surrounding cataracts. Cataract awareness was lowest in the group without formal education (50%). In addition, 17 participants demonstrated poor knowledge before the informational brochure was distributed, and all improved to "good" knowledge after. Following brochure distribution, there was an improved knowledge of cataract anatomy (correct answer: 32.9% to 94.6%), treatment of cataracts (80% to 95.9%), cataract symptoms (36.7% to 95.9%), age at risk (88.8% to 97.3%), and relationship to blindness (93.5% to 98.6%). In contrast, overall knowledge of the risk factors for cataracts (46.8% to 37%) and prevention of the onset of the cataract (81.3% to 77%) slightly decreased after the brochure was given. Overall, the increase in the number of correct answers after the brochure was not significant (p = 0.25). Conclusions To our knowledge, this is a rare study to assess the effect of informational brochures on cataract knowledge in rural Ecuador. This study was limited by selection bias and did not look at the long-term recall of knowledge. The results of this study suggest that brochures can improve health awareness; however, brochures alone may not be enough. Additional assessments on the use of oral and visual aids are needed. Health education efforts should go beyond simple brochures and focus on innovative strategies to improve health education and communication efforts.

Development, Validation, and Impact of Patient Information Booklet for Gamma Knife Radiosurgery.

Background: The inadequate awareness in the general population is a primary concern for the management of various neurosurgical ailments treated with gamma knife radiosurgery (GKRS). Objective: Our study aimed to assess the written patient information by focusing on readability, recall, communication, compliance, and patient satisfaction. Methodology: The senior author formulated disease-specific patient information booklets. The booklets comprised two segments: general information about GKRS and disease-specific information. The common themes for discussion were "What is your disease?", "What is gamma knife radiosurgery?", "What are the alternatives to gamma knife radiosurgery," "The benefits of gamma knife radiosurgery," "About gamma knife radiosurgery," "Recovering from gamma knife radiosurgery," "Follow up," "What are the risks," and "Contact." The booklet was emailed after the first consultation to 102 patients. Patients' socioeconomic status and comprehensibility were assessed on validated scoring. Post-GKRS, we emailed a custom-made Google feedback survey of 10 leading questions about the role of patient information booklet in educating and decision-making process. We tried to assess if the booklet helped the patient understand the disease and treatment options. Results: In total, 94% of patients read it thoroughly and understood it to their satisfaction. They also shared and discussed the information booklet with their family members and relatives (92%). Furthermore, 96% of patients found the disease-specific information informative. For 83% of patients, the information brochure cleared the doubts regarding the GKRS completely. For 66% of patients, their expectations met the reality. In addition, 94% of patients still recommended giving the booklet to the patients. All high, upper- and middle-class responders were happy and content with the patient information booklet. In contrast, 18 (90%) of the lower middle class and 2 (66.7%) of the lower class considered the information useful to the patients. Also, 90% patients found the language of the patient information booklet comprehensible and not too technical to understand. Conclusions: An essential component of disease management is to relieve the anxiety and confusion in the patient's mind and help one choose a treatment modality among the available options. A patient-centric booklet helps impart knowledge, clears doubts, and provides an opportunity to discuss options with family members.

Evaluation of hazard brochures using topic viewing durations: Application to tsunami evacuation brochures.

This study describes a novel method of assessing risk communication effectiveness by reporting an evaluation of a tsunami information brochure by 90 residents of three Pacific coast communities that are vulnerable to a Cascadia Subduction Zone earthquake and tsunami-Commencement Bay, Washington; Lincoln City, Oregon; and Eureka, California. Study participants viewed information that was presented in DynaSearch, an internet-based computer system that allowed them to view text boxes and tsunami inundation zone maps. DynaSearch recorded the number of times each text box or map was clicked and the length of time that it was viewed. This information viewing phase was followed by questionnaire pages assessing important aspects of tsunami hazard and sources of tsunami warnings. Participants gave the longest click durations to what to do in the emergency period during earthquake shaking and in its immediate aftermath before a tsunami arrives-topics that should be displayed prominently in tsunami brochures and emphasized in talks to community groups. The smallest adjusted click durations were associated with advance preparations for a tsunami-topics that can be posted on websites whose URLs are printed in the brochures.

Effectiveness of an educational module in improving knowledge, awareness and perception among pregnant women regarding the safe use of prenatal ultrasound.

Background: Lack of public understanding, perception and awareness of the biological effects of prenatal ultrasound has led to the non-medical use of ultrasound. An educational programme is required to enlighten pregnant women and the public regarding prenatal ultrasound safety. Objective: To evaluate the effectiveness of educational modules (video and brochure) in improving knowledge, awareness and perception (KAP) among pregnant women regarding prenatal ultrasound safety. Methods: This is a quasi-experimental study with a pre-and post-test design. This study recruited 51 pregnant women as respondents from the Obstetrics and Gynaecology clinic (O&G) of Hospital Canselor Tuanku Muhriz (HCTM). The first phase of the study was conducted by distributing a set of closed-ended questionnaires with multiple choice and Likert scale answers to assess the KAP of pregnant women regarding the safe use of prenatal ultrasound, followed by educational modules where the respondents were allocated into three groups (17 watched a video, 17 received brochure and 17 received combined media). After the intervention, the respondents' KAP were assessed using the same questionnaire. Results: The Wilcoxon signed rank test showed that educational modules like video, brochure and combined media had a statistically significant increase in post-test scores over the pre-test scores (video: mean rank = 9.00, p < 0.05) (brochure: mean rank = 9.79,p < 0.05) and (combined media: mean rank = 10.17, p > 0.05). The Kruskal Wallis test indicated that educational video was more effective in improving the KAP of pregnant women than the brochure and combined media (mean rank = 34.62, p < 0.05). Among the parameters, the occupation has the strongest positive correlation with the post-test knowledge score in improving the KAP of pregnant women regarding the safe use of prenatal ultrasound. Conclusion: The educational video is the most effective approach for enhancing pregnant women's KAP. The educational module on the safety of prenatal ultrasound is thought to dispel myths by providing accurate information to audiences from various backgrounds.

Adherence to WHO Criteria on Drug Promotion Literature: An Exploratory Study From a Tertiary Healthcare Facility in South-West Nigeria.

Introduction: In many low and middle-income countries (LMIC), drug promotional literature (DPL) remains one of the main sources of drug information for physicians. Studies conducted in many LMICs showed poor compliance to the WHO guidelines for ethical drug promotion especially in the area of information about excipients, adverse drug reactions, drug-drug interactions and contra-indications. These inadequacies in the information provided may mislead the prescriber with potential adverse consequences among patients using the medicines. Nigeria has a big pharmaceutical sector which is poorly regulated and we hypothesize that such unethical drug promotional practices may exist. This study therefore set out to assess compliance to the WHO ethical drug promotion (using DPL) at the Ekiti State University Teaching Hospital (EKSUTH), Ado-Ekiti, South-West Nigeria. Methodology: This was a descriptive cross-sectional study conducted in several specialist clinics of EKSUTH, Ado-Ekiti. Printed DPLs (brochures and leaflets) were collected from these clinics, collated using a pre-designed data collection form and analyzed using the WHO ethical criteria for medicinal drug promotion. Results:Two hundred seventy-five DPLs were screened A total of out of which 234 DPLs were selected after screening to after removal of duplications. Only 5 (2.1%) DPLs met all the WHO criteria. DPLs promoting antibiotics, cardiovascular drugs, and vitamins/nutritional supplements were in the majority (22.2%, 17.1%, and 11.5% respectively. Most of the DPLs had the generic (223; 95.3%) and brand (234; 100%) names, active ingredients (209; 89.3%), excipients (149; 63.7%), and indications (232; 99.1%). Information about adverse drug reactions (76; 32.5%), contra-indications (73; 31.2%), and drug interactions (46; 19.7%) was less represented. Only 59 (25.2%) DPLs had references. Fixed-dose combination drugs made up 34.6% of drugs being promoted. Conclusion:The DPLs assessed in this study had low adherence to WHO ethical drug promotion criteria especially those related to adverse drug reaction, drug interactions, and contra-indications.

Effects of Information Provided to University Students Through an Educational Brochure on Health Beliefs and Testicular Self-Examination.

This study aimed to examine the effect of an educational brochure about testicular cancer and its early diagnosis on the health beliefs and self-examination of participants. The pretests/posttests were conducted in a quasi-experimental design with non-randomized groups and a control group of university students. The study recruited students enrolled in the psychological counseling and guidance department of a Turkish public university. The research sample comprised 92 students, 48 in the experimental and 44 in the control group. An educational brochure about testicular cancer and self-examination was provided to the experimental group. The data includes a personal information form, testicular cancer and health beliefs scale about testicular self-examination, and the form for self-examination. Mann Whitney U, Wilcoxon, and chi-square analyses were performed for data analysis. A significant difference was found between the scores of the experimental and control groups regarding seriousness/caring, benefit and health motivation, obstacles, and self-efficacy (p < 0.05). Moreover, the testicular self-examination ratio was determined as 83.3% in the experimental group and 4.5% in the control group. It can be asserted that the training brochure is effective in promoting the self-examination of testicles. It may be recommended to conduct experimental studies with larger study groups to increase testicular self-examination.

Preclinical efficacy in investigator's brochures: Stakeholders' views on measures to improve completeness and robustness.

AIMS: Research ethics committees and regulatory agencies assess whether the benefits of a proposed early-stage clinical trial outweigh the risks based on preclinical studies reported in investigator's brochures (IBs). Recent studies have indicated that the reporting of preclinical evidence presented in IBs does not enable proper risk-benefit assessment. We interviewed different stakeholders (regulators, research ethics committee members, preclinical and clinical researchers, ethicists, and metaresearchers) about their views on measures to increase the completeness and robustness of preclinical evidence reporting in IBs. METHODS: This study was preregistered (https://osf.io/nvzwy/). We used purposive sampling and invited stakeholders to participate in an online semistructured interview between March and June 2021. Themes were derived using inductive content analysis. We used a strengths, weaknesses, opportunities and threats matrix to categorize our findings. RESULTS: Twenty-seven international stakeholders participated. The interviewees pointed to several strengths and opportunities to improve completeness and robustness, mainly more transparent and systematic justifications for the included studies. However, weaknesses and threats were mentioned that could undermine efforts to enable a more thorough assessment: The interviewees stressed that current review practices are sufficient to ensure the safe conduct of first-in-human trials. They feared that changes to the IB structure or review process could overburden stakeholders and slow drug development. CONCLUSION: In principle, more robust decision-making processes align with the interests of all stakeholders and with many current initiatives to increase the translatability of preclinical research and limit uninformative or ill-justified trials early in the development process. Further research should investigate measures that could be implemented to benefit all stakeholders.

Effect of educational brochure compared with video on disease-related knowledge in patients with juvenile idiopathic arthritis: A randomized controlled trial.

Introduction: Patient education plays an important role in the management of chronic diseases such as juvenile idiopathic arthritis (JIA). This study compared the effectiveness of a brochure and a video regarding JIA-related knowledge immediately after the intervention, and at 4 weeks post-intervention. Methods: A prospective randomized controlled trial was conducted. Patients with JIA or parents were randomized to receive education from either a brochure (n = 50) or a video (n = 50) at the clinic. Participants answered questionnaires about disease-specific knowledge before the intervention (T0), immediately after the intervention (T1), and at follow-up 4 weeks later (T2). The questionnaire comprised 15 multiple-choice questions. Final scores ranged from 0 to 15, and were scaled from 0% to 100% to calculate the percentage of knowledge scores. Ninety participants completed the questionnaire at T2 (42 in the brochure and 48 in the video group). Results: The mean percentage of knowledge scores at T0 was not significantly different between the brochure group and the video group. At T1, the mean percentage of knowledge scores was significantly higher in the video group compared with the brochure group (86.7 ± 12.9% vs. 76.0 ± 21.4%, p = 0.003). Among parents with an educational level below secondary school, the mean percentage of knowledge scores at T1 was significantly higher in the video group compared with the brochure group (83.5 ± 14.4% vs. 69.1 ± 23.2%, p = 0.006). Participants in both groups had significantly higher mean percentage of knowledge scores at T2 compared with T0 (72.7 ± 20.3% vs. 51.1 ± 24.7%, p < 0.001 in the brochure group and 78.3 ± 15.7% vs. 56.1 ± 21.9%, p < 0.001 in the video group). There was no significant difference in the mean percentage of total score change between T2 and T1 between the brochure and video groups (-4.7 ± 13.3% vs. -8.5 ± 11.0%, p = 0.152). Conclusion: The video was more effective for improving disease-related knowledge immediately post-intervention, particularly in participants with limited education. Although both educational tools had lasting effects on knowledge, the retention rate declined at 4 weeks after both interventions. Trial registration: Thai Clinical Trials Registry (TCTR)20200310004, retrospectively registered since 06/03/2020.

Nurse information in Spanish intensive care units: Formal or informal role? Multicentre study.

OBJECTIVES: To evaluate the brochure provided to relatives on admission to Spanish Intensive Care Units (ICU) regarding nursing information. METHODOLOGY: Descriptive, cross-sectional, multicentre study from September-December 2019. A total of 280 adult ICUs were included, according to the list of the Spanish Society of Intensive Care. The brochure was requested through personal contact, phone call, twitter, or hospital website. ANALYSED VARIABLES: Hospital (public/private), university (yes/no), visiting (open/closed), medical and nurse information. Descriptive statistics and X2 test (relations nurse information and other variables). RESULTS: Data were collected from 228 ICU (81.4%), of which 25 (11%) did not have a brochure. A total of 77.8% were public and 49.8% university hospitals. Of the hospitals, 94.1% had closed visiting hours, although 42.4% supplemented it with flexible. All the hospitals included daily medical information with an established timetable, 21.7% (n = 44) contained nurse information, 27.3% with established hours and 38.6% during visits. Of the nursing information, 79.5% referred to care, 29.5% to needs, 13.6% to well-being, 15.9% to the patient's condition, 11.4% to the environment, 9.1% to observations, and 29.5% to clarifications. A total of 17.2% of all ICU offered to collaborate in care. Of the brochures with nurse information, 90.9% were public hospitals and 9.1% were private (p = .02). Of the hospitals, 65.9% were university compared to 34.1% who were not (p = .02). CONCLUSIONS: While medical information is consistently reflected in all brochures, only a few contain nursing information with generic and non-homogeneous and specific content. These results contrast with the reality of the ICU, where the nurse is the professional with the greatest contact with the family. The official provision of nursing information occurs more frequently in public and university hospitals. It is necessary to standardise this information, since as a responsible part of the care process, nurses must communicate their care in a formal manner, and thus help make their work visible.

Información enfermera en las unidades de cuidados intensivos españolas: ¿rol formal o informal? Estudio multicéntrico / Nurse information in Spanish intensive care units: Formal or informal role? Multicentre study

Objetivos: Evaluar la guía de acogida proporcionada a los familiares en las unidades de cuidados intensivos (UCI) españolas respecto a la información enfermera. Metodología: Estudio descriptivo, transversal multicéntrico de septiembre-diciembre de 2019. Se incluyeron 280 UCI de adultos, según el listado de la Sociedad Española de Cuidados Intensivos. El folleto se solicitó mediante contacto personal, llamada telefónica, Twitter o web del hospital. Variables analizadas: Hospital (público/concertado o privado), universitario (sí/no), visita (abierta/cerrada), información médica y enfermera. Estadística descriptiva y prueba Chi cuadrado (relación información enfermera y resto de variables). Resultados: Se recogieron datos de 228 UCI (81,4%), de las cuales 25 (11%) no disponían de folleto. Un 77,8% eran públicas/concertadas y el 49,8% universitarias. El 94,1% tenían horario cerrado, aunque el 42,4% lo complementaban con uno flexible o de acompañamiento. El 100% incluía información médica diaria con horario establecido. El 21,7% (n=44) contenía información enfermera, un 27,3% con horario establecido y un 38,6% durante las visitas. En el 79,5% la información enfermera hacía referencia a cuidados, en el 29,5% a necesidades, en el 13,6% al bienestar, en el 15,9% al estado del paciente, en el 11,4% al entorno, en el 9,1% a observaciones y en el 29,5% a aclaraciones. El 17,2% de todas las UCI ofrecía colaborar en los cuidados. De los folletos con información enfermera el 90,9% eran hospitales públicos/concertados y el 9,1% privados (p=0,02). El 65,9% eran universitarios frente al 34,1% que no lo eran (p=0,02). Conclusiones: Mientras que la información médica queda reflejada de forma unánime, una baja proporción de folletos citan la información enfermera, con un contenido poco homogéneo y concreto. Estos resultados contrastan con la realidad de la UCI, donde la enfermera es el profesional con mayor contacto con la familia.(AU)

Objectives: To evaluate the brochure provided to relatives on admission to Spanish Intensive Care Units (ICU) regarding nursing information. Methodology: Descriptive, cross-sectional, multicentre study from September-December 2019. A total of 280 adult ICUs were included, according to the list of the Spanish Society of Intensive Care. The brochure was requested through personal contact, phone call, twitter, or hospital website. Analyzed variables: Hospital (public/private), university (yes/no), visiting (open/closed), medical and nurse information. Descriptive statistics and X2 test (relations nurse information and other variables). Results: Data were collected from 228 ICU(81.4%), of which 25(11%) did not have a brochure. A total of 77.8% were public and 49.8% university hospitals. Of the hospitals, 94.1% had closed visiting hours, although 42.4% supplemented it with flexible. All the hospitals included daily medical information with an established timetable, 21.7%(n=44) contained nurse information, 27.3% with established hours and 38.6% during visits. Of the nursing information, 79.5% referred to care, 29.5% to needs, 13.6% to well-being, 15.9% to the patient's condition, 11.4% to the environment, 9.1% to observations, and 29.5% to clarifications. A total of 17.2% of all ICU offered to collaborate in care. Of the brochures with nurse information, 90.9% were public hospitals and 9.1% were private (P=.02). Of the hospitals, 65.9% were university compared to 34.1% who were not (P=.02). Conclusions: While medical information is consistently reflected in all brochures, only a few contain nursing information with generic and non-homogeneous and specific content. These results contrast with the reality of the ICU, where the nurse is the professional with the greatest contact with the family.(AU)

A Simple Brochure Improves Disposal of Unused Opioids: An Observational Cross-Sectional Study.

BACKGROUND: We evaluated the effectiveness of a simple, low-cost educational brochure in improving disposal rates of unused opioids after outpatient upper extremity surgery. METHODS: This cross-sectional study enrolled eligible adult patients from a peripheral nerve clinic between November 2017 and September 2018. Patients either received or did not receive the educational brochure, which outlined a simple method to dispose of unused opioids and completed a survey at 2 weeks after surgery. We compared the proportion of patients who disposed of unused opioids after surgery between the group that had received the brochure and the group that had not. Categorical data were analyzed with χ2 test, proportions data with binomial tests, and numerical data with Mann-Whitney U test, all with a significance level of P < .05. RESULTS: There were 339 survey respondents. Nineteen patients who did not meet inclusion criteria were excluded. Of the 320 remaining patients, 139 received the brochure and 181 did not. An additional 55 patients were excluded due to preoperative opioid use. Overall, 35.3% of recipients and 38.3% of those who did not receive the brochure used all of their prescribed opioid medication (P = .625; confidence interval = -14.6%-8.8%). Among patients with unused opioid medication, a significantly higher proportion of brochure recipients disposed of the medicine compared with those who did not receive the brochure (46.7% vs 19.6%, P < .001). CONCLUSIONS: Distribution of an educational brochure significantly improved disposal of unused opioids after surgery. This easily implemented intervention can improve disposal of unused opioids and ultimately decrease excess opioids available for diverted use in the community.

Acceptance and Benefits of Two Different Strategies to Timely Integrate Specialist Palliative Care into Routine Cancer Care: A Randomized Pilot Study.

BACKGROUND/AIMS: The aim of this study is to investigate the acceptance and benefits of two different strategies to timely integrate specialist palliative care (SPC) in routine cancer care: commonly recommended early SPC counselling versus an informational brochure plus SPC counselling upon patients' request. METHODS: Patients diagnosed with incurable cancer within the last 6-12 weeks were sequentially randomized. Endpoints were acceptance of the two strategies after 3 months as well as the use of SPC counselling and psychosocial support, presence of advance directives, palliative care outcome (Integrated Palliative care Outcome Scale [IPOS]), and psychosocial distress (Distress Thermometer [DT]) after 3 and 6 months. In a qualitative part, SPC consultations were analyzed using a content analysis. RESULTS: Overall, 43 patients received SPC counselling and 37 a brochure with SPC counselling on demand. In the brochure group, only one patient later registered for SPC counselling from own initiative. SPC timing was appropriate in 70% of patients (75% counselling/61% brochure, n.s.). Sufficiency, helpfulness and relevance of information, provision of security, and help with finding contacts for specific support were perceived adequate in both groups. No significant differences were found regarding potential effects of the interventions on IPOS or DT after 3 and 6 months. The use of psychosocial support was comparable between the groups and 4 patients had new advance directives (3 counselling/1 brochure). Five key themes of SPC consultations were identified: symptoms, rapport, coping, illness understanding, and advance care planning. CONCLUSIONS: Both SPC integration strategies were well accepted. However, patients seem not to benefit from a brochure in terms of initiating SPC counselling timely after a palliative cancer diagnosis.

Soins plus ­ mise en place d'une intervention à trois volets visant à accroître la visibilité et la disponibilité du pharmacien dans un hôpital pédiatrique : une étude randomisée contrôlée.

BACKGROUND: The pharmacist's role within the multidisciplinary team is often poorly understood. Various interventions can be put into place to promote the role of the pharmacist in the hospital setting with families, patients, and other health care professionals. Few studies have described the feasibility and assessed the impact of such interventions, particularly in pediatrics. OBJECTIVES: To describe the implementation of a 3-part intervention aimed at increasing the visibility of pharmacists and their role on the treatment team, with the goal of optimizing the pharmaceutical care of hospitalized patients in the general pediatric units of CHU Sainte-Justine, in Montréal, Quebec, and to compare the perceptions and satisfaction of patients' parents and of health care professionals with exposure to either usual pharmaceutical care or to pharmaceutical care incorporating the intervention. METHODS: This single-blind, randomized, controlled experimental study involved patients admitted to general pediatric units between March 5 and August 8, 2019. In addition to usual care, the intervention included delivery of an information brochure about pharmaceutical services and care, access to a telephone line (which allowed families and patients to contact a pharmacy resident during their stay in hospital and up to 1 month after discharge), and completion of a standardized discharge form by the pharmacist responsible for the patient. The participants and health professionals concerned were surveyed to determine their perceptions and level of satisfaction. RESULTS: A total of 641 participants were included in the study, 321 in the intervention group and 320 in the control group. The brochure was given to all parents in the intervention group. Twelve phone calls were made through the dedicated telephone line. The standardized discharge form was completed for 46.7% (150/321) of the participants in the intervention group. Most of the parents and patients who responded to the survey, in either group (81.2%, 298/367), reported satisfaction with the pharmaceutical services and care received. Of participants in the intervention group, 83.9% were satisfied with the pharmaceutical care and services received, compared with 78.5% of those in the control group (p = 0.18). In addition, 60.3% (111/184) of participants in the intervention group said that the information about medications that was provided during the hospital stay gave them new knowledge, compared with 48.1% (87/181) of those in the control group (p = 0.019). The results of the survey showed that care providers were in agreement with the intervention. CONCLUSIONS: The 3 components of the intervention were implemented in the pediatric units over a period of 5 months. The intervention was perceived as positive by the parents and care providers concerned, and the respondents were mostly satisfied with the services and pharmaceutical care offered.

Pre-clinical study of IRDye800CW-nimotuzumab formulation, stability, pharmacokinetics, and safety.

BACKGROUND: Epidermal growth factor receptor (EGFR) is a target for cancer therapy as it is overexpressed in a wide variety of cancers. Therapeutic antibodies that bind EGFR are being evaluated in clinical trials as imaging agents for positron emission tomography and image-guided surgery. However, some of these antibodies have safety concerns such as infusion reactions, limiting their use in imaging applications. Nimotuzumab is a therapeutic monoclonal antibody that is specific for EGFR and has been used as a therapy in a number of countries. METHODS: Formulation of IRDye800CW-nimotuzumab for a clinical trial application was prepared. The physical, chemical, and pharmaceutical properties were tested to develop the specifications to determine stability of the product. The acute and delayed toxicities were tested and IRDye800CW-nimotuzumab was determined to be non-toxic. Non-compartmental pharmacokinetics analysis was used to determine the half-life of IRDye800CW-nimotuzumab. RESULTS: IRDye800CW-nimotuzumab was determined to be non-toxic from the acute and delayed toxicity study. The half-life of IRDye800CW-nimotuzumab was determined to be 38 ± 1.5 h. A bi-exponential analysis was also used which gave a t1/2 alpha of 1.5 h and t1/2 beta of 40.8 h. CONCLUSIONS: Here, we show preclinical studies demonstrating that nimotuzumab conjugated to IRDye800CW is safe and does not exhibit toxicities commonly associated with EGFR targeting antibodies.

How to Interpret an Investigator's Brochure for Meaningful Risk Assessment: Results of an AGAH Discussion Forum.

PURPOSE: A discussion forum was hosted by the Association for Applied Human Pharmacology (AGAH e.V.) to critically debate how to interpret and optimise the Investigator's Brochure (IB) for meaningful risk assessment of early clinical trials. MATERIALS AND METHODS: Four topics were specifically discussed: deficiencies/uncertainties in IBs, guidance for the investigator, reference safety information, and potential risks for human subjects associated with inadequate non-clinical safety assessment in the IB. In each case, 43 participants took part in a real-time online survey with pre-defined questions to capture the audience's opinion. RESULTS: The 'Summary of Data and Guidance for the Investigator' was considered as the section of the IB with the highest need for improvement with emphasis on readability, comprehensibility, timeliness of data, and appropriateness for risk assessment. It was suggested that the IB should at least be signed by the sponsor's scientist responsible for the content on pharmacology and toxicology. It was agreed that sponsors should consider thoroughly whether changes to an IB constitute a substantial amendment, and that the IB should include a section on the change history. Non-clinical pharmacology studies with negative outcomes should be reported in the IB in order to avoid assessment bias. The reference safety information for expectedness assessment of suspected serious adverse reactions should be provided as a stand-alone section of the IB. CONCLUSION: The overall consensus was that an optimised presentation of data will ensure the best possible understanding of a compound's characteristics and an optimal benefit-risk assessment which will safeguard the participants in clinical trials.

Nonclinical & clinical interface - extrapolation of nonclinical data to support Phase I clinical studies.

A review of the Investigator's Brochure and Clinical Study Reports for 58 non-oncology small molecule and biopharmaceutical drug candidates tested in a healthy volunteer subject population was conducted. Key findings were (1) a vital role for nonclinical pharmacology and toxicology testing was confirmed to allow setting of clinical starting dose and supporting use of highest dose based on No Observed Adverse Effect Levels (NOAELs), Pharmacologically Active Doses (PADs) and other approaches, (2) for clinical starting dose calculation, reference to the NOAEL was key, whether in calculation of a Maximum Recommended Starting Dose (MRSD), or by supporting PAD approaches (small molecules); or, through pharmacokinetic/pharmacodynamic (PK/PD) data modelling (biopharmaceuticals), (3) starting dose for small molecules was very conservative with human exposure >100- to 100-fold (46%) lower or between 10- and 100-fold (41%) lower than that seen at the NOAEL; high margins over exposure seen at NOAELs were also seen for biopharmaceuticals, (4) at the highest doses used, about 25% of studies for small molecules and 12% of studies for biopharmaceuticals showed exposure greater than that seen at the NOAEL and (5) adverse event evaluation showed that our current paradigm of moving from nonclinical testing into SAD/MAD Phase I testing is remarkably safe.

Levelling the Translational Gap for Animal to Human Efficacy Data.

Reports of a reproducibility crisis combined with a high attrition rate in the pharmaceutical industry have put animal research increasingly under scrutiny in the past decade. Many researchers and the general public now question whether there is still a justification for conducting animal studies. While criticism of the current modus operandi in preclinical research is certainly warranted, the data on which these discussions are based are often unreliable. Several initiatives to address the internal validity and reporting quality of animal studies (e.g., Animals in Research: Reporting In Vivo Experiments (ARRIVE) and Planning Research and Experimental Procedures on Animals: Recommendations for Excellence (PREPARE) guidelines) have been introduced but seldom implemented. As for external validity, progress has been virtually absent. Nonetheless, the selection of optimal animal models of disease may prevent the conducting of clinical trials, based on unreliable preclinical data. Here, we discuss three contributions to tackle the evaluation of the predictive value of animal models of disease themselves. First, we developed the Framework to Identify Models of Disease (FIMD), the first step to standardise the assessment, validation and comparison of disease models. FIMD allows the identification of which aspects of the human disease are replicated in the animals, facilitating the selection of disease models more likely to predict human response. Second, we show an example of how systematic reviews and meta-analyses can provide another strategy to discriminate between disease models quantitatively. Third, we explore whether external validity is a factor in animal model selection in the Investigator's Brochure (IB), and we use the IB-derisk tool to integrate preclinical pharmacokinetic and pharmacodynamic data in early clinical development. Through these contributions, we show how we can address external validity to evaluate the translatability and scientific value of animal models in drug development. However, while these methods have potential, it is the extent of their adoption by the scientific community that will define their impact. By promoting and adopting high quality study design and reporting, as well as a thorough assessment of the translatability of drug efficacy of animal models of disease, we will have robust data to challenge and improve the current animal research paradigm.

Effect of the patient information brochure in communicating the risks associated with crizotinib treatment to patients with non-small cell lung cancer (NSCLC) in Europe.

Crizotinib (XALKORI® ) is indicated for anaplastic lymphoma kinase-positive and ROS1-positive advanced non-small cell lung cancer. This study evaluated the distribution of the crizotinib patient information brochure (PIB) in Europe and patient knowledge of the key messages in the PIB. A cross-sectional survey was conducted in 10 European countries among patients who received crizotinib to ascertain whether each patient received and read the PIB, and his/her knowledge of its key messages on hepatotoxicity, interstitial lung disease/pneumonitis, QTc prolongation, bradycardia, and vision disorders. Of the 341 patients contacted, 40 responded (11.7%), and 39 patients were eligible. A total of 77% of respondents acknowledged receiving the PIB, of which, 93% reported reading it. Knowledge of the individual side effects ranged from 36% to 85%, and precautions for use ranged from 56% to 67%. Understanding the reasons for calling a physician ranged from 54% to 85%. Knowledge of each of the 6 key side effects was greater among readers of the PIB compared to non-readers or respondents who did not recall receiving the PIB. Approximately three-quarters of survey respondents recalled receiving the crizotinib PIB and respondents who read the PIB were more knowledgeable of the key side effects of crizotinib than those who did not read or receive. Caution should be taken in generalizing these results because of the potential for selection bias and small sample size. These survey results suggest that the crizotinib PIB may be an effective risk communication tool for crizotinib-treated patients in Europe.

The effect of the video and brochure via donor recruitment on fear, anxiety and intention: Randomized controlled trial.

Although voluntary blood donation is important in terms of sustainable blood supply, voluntary blood donation rates in the world and in our country are behind the desired target. University students are an important group in achieving the goal. The study was planned among 551 university students between 19-21 March 2018.It was planned as a single-blind randomized controlled study in order to evaluate the factors affecting students' blood donation decision and the effect of brochure and video information on fear, anxiety and intention. The data obtained by using Blood Donation Questionnaire and State Anxiety Scale and p ≤ 0.05 was accepted as significant. As a result of the study, 37.9 % of the students reported that they did not give blood due to health reasons, 26 % insecurity and 24.1 % fear. The increase in after the intervention knowledge level was mostly in the group of videos and improved brochures (p < 0.001).There was no difference between the groups in terms of the State Anxiety Scale mean scores p> 0.05). In after the intervention, those who intend to give blood have higher knowledge and their fear and anxiety scores less than those not intend to give blood (p < 0.05). There was no difference between the groups in terms of intention to give blood after the intervention (p> 0.05). As a result, it was found that the information given through the developed brochures and videos increased the level of knowledge, had no effect on the anxiety level and it can be said that the improved brochure has positive effects on intent and fear.