Increasing the transparency of systematic reviews: presenting a generalized registration form.

This paper presents a generalized registration form for systematic reviews that can be used when currently available forms are not adequate. The form is designed to be applicable across disciplines (i.e., psychology, economics, law, physics, or any other field) and across review types (i.e., scoping review, review of qualitative studies, meta-analysis, or any other type of review). That means that the reviewed records may include research reports as well as archive documents, case law, books, poems, etc. Items were selected and formulated to optimize broad applicability instead of specificity, forgoing some benefits afforded by a tighter focus. This PRISMA 2020 compliant form is a fallback for more specialized forms and can be used if no specialized form or registration platform is available. When accessing this form on the Open Science Framework website, users will therefore first be guided to specialized forms when they exist. In addition to this use case, the form can also serve as a starting point for creating registration forms that cater to specific fields or review types.

Diseño de modelo de registro electrónico para el desarrollo del Plan de Alta de Enfermería / Design of electronic record model for the development of the Nursing Discharge Plan / Desenho de modelo de prontuário eletrônico para elaboração do Plano de Alta de Enfermagem

El escenario actual de transición hacia el registro digital en Uruguay es una oportunidad para diseñar estándares interoperables que faciliten y optimicen el tiempo de registro, para proponerlos en la Historia Clínica Electrónica, contribuyendo de esta manera al desarrollo y visibilidad de la disciplina y al fortalecimiento de políticas de Estado. Objetivo: fue diseñar un modelo de registro electrónico de la Gestión del Cuidado de Enfermería Profesional al alta. Material y métodos: se realizó un estudio de tipo cuantitativo, para el consenso y validación de contenidos por medio de expertos aplicando la técnica Delphi. Los expertos que participaron fueron profesionales vinculados al registro electrónico, Nacionales e Internacionales, residentes en América Latina y el Caribe. Por medio de un cuestionario on line se relevó la información proveniente de los expertos, obteniendo consenso en la segunda ronda de respuestas, este proceso abarcó el primer y segundo semestre del año 2019. Resultados: se propusieron variables para el proceso y su forma de registro electrónico, se realizó primera ronda con un 61 % de aprobación de las variables propuestas (X= 1 - 1.16/ Dst= 0,00 - 0,04), el 11 % fueron excluidas (X= 1,4/ Dst= 0,63) y el 28 % requirió reformulación (X= 1,2/ Dst= 0,49). Conclusión: se construyó un modelo de plan de alta de Enfermería conteniendo 25 variables y su forma de registro electrónico.

The current scenario of transition towards digital registration in Uruguay is an opportunity to design interoperable standards that facilitate and optimize registration time, to propose them in the Electronic Medical Record, thus contributing to the development and visibility of the discipline and the strengthening of state policies. Objective: was to design an electronic record model of Professional Nursing Care Management at discharge. Material and methods: a quantitative study was carried out, for the consensus and validation of contents by experts applying the Delphi technique. The experts who participated were professionals linked to the electronic registry, National and International, residing in Latin America and the Caribbean. Through an online questionnaire, the information from the experts was collected, obtaining consensus in the second round of responses, this process covered the first and second semester of 2019. Results: variables were proposed for the process and its form of registration electronic, the first round was carried out with 61 % approval of the proposed variables (X= 1 -1.16/ Dst=0.00 - 0.04), 11 % were excluded (X= 1.4/ Dst=0, 63) and 28 % required reformulation (X=1.2/ Dst=0.49). Conclusion: A Nursing discharge plan model was built containing 25 variables and its electronic record form.

O cenário atual de transição para o registro digital no Uruguai é uma oportunidade para desenhar padrões interoperáveis que facilitem e otimizem o tempo de registro, para propô-los no Prontuário Eletrônico, contribuindo assim para o desenvolvimento e visibilidade da disciplina e o fortalecimento das políticas estatais. Objetivo: foi elaborar um modelo de prontuário eletrônico do Gerenciamento do Cuidado Profissional de Enfermagem na alta. Material e métodos: foi realizado um estudo quantitativo, para consenso e validação de conteúdo por especialistas aplicando a técnica Delphi. Os peritos que participaram foram profissionais vinculados ao registro eletrônico, Nacional e Internacional, residentes na América Latina e Caribe. Por meio de um questionário online, foram coletadas as informações dos especialistas, obtendo consenso na segunda rodada de respostas, esse processo abrangeu o primeiro e segundo semestre de 2019. Resultados: foram propostas variáveis para o processo e sua forma de registro, primeira rodada foi realizada com 61 % de aprovação das variáveis propostas (X=1 - 1,16/ Dst= 0,00 - 0,04), 11 % foram excluídas (X=1,4/ Dst= 0,63) e 28 % necessitaram de reformulação (X= 1,2/Dst= 0,49). Conclusão: Foi construído um modelo de plano de alta de Enfermagem contendo 25 variáveis e seu formulário de registro eletrônico.

Adaptação e evidências de validade da Escala de Mindsets da Sexualidade / Adaptation and validity evidence for the Sexual Destiny and Sexual growth beliefs measure / Adaptación y evidencias de validez de la Escala de Mindsets de la Sexualidad

Este trabalho apresenta dois estudos que visaram adaptar e buscar evidências de validade da Sexual Destiny and Sexual Growth Beliefs Measure para a população brasileira. Essa escala tem como objetivo medir o quanto as pessoas acreditam que satisfação sexual depende de encontrar o parceiro certo ou de investimento na relação. No primeiro estudo, realizou-se a adaptação transcultural, da qual participaram quatro tradutores, quatro pesquisadores e clínicos em famílias, uma amostra do público-alvo (N = 9) para verificar compreensão dos itens e finalmente 100 respondentes para o estudo piloto, que revelou boa consistência interna. O segundo estudo (N = 637) confirmou a estrutura de dois fatores da escala e a invariância entre grupos de homens e mulheres. Outras evidências de validade foram obtidas por meio da correlação com escalas de qualidade conjugal e satisfação de vida. Conclui-se que a escala foi adaptada com sucesso para a população brasileira e que foram demonstradas evidências de validade.(AU)

This paper presents two studies that aimed to adapt and seek evidence of validity for the Sexual destiny and sexual growth beliefs measure for the Brazilian population. This scale aims to measure how much people believe that sexual satisfaction depends on finding the right partner or depends on investment in the relationship. In the first study, a cross-cultural adaptation was carried out, with the participation of four translators, four experts in the study with families, a sample of the target audience (N = 9) to verify the understanding of the items, and finally 100 respondents for the pilot study, which revealed good internal consistency. The second study (N = 637) confirmed the two-factor structure and the invariance between men and women. Other validity evidence was obtained through the correlation with scales of marital quality and life satisfaction. The scale was successfully adapted for the Brazilian population and evidence of its validity was demonstrated.(AU)

Este trabajo presenta dos estudios que visaron adaptar y buscar evidencias de validez de la Sexual destiny and sexual groth beliefs measure para la población brasileña. Esta escala tiene como objetivo mensurar en qué medida las personas creen que la satisfacción sexual depende de encontrar la pareja adecuada o de invertir en la relación. En el primer estudio se realizó la adaptación transcultural, en la cual participaron cuatro traductores, cuatro investigadores y clínicos en familias, una muestra del público objetivo (N=9) para averiguar la comprensión de los ítems y, finalmente, 100 encuestados contestaron al estudio piloto, que reveló una buena consistencia interna. El segundo estudio (N=637) confirmó la estructura de dos factores de la escala y la invarianza entre grupos de hombres y mujeres. Otras evidencias de validez fueron obtenidas a través de la correlación con escalas de calidad marital y satisfacción con la vida. Se concluye que la escala fue adaptada con éxito para la población brasileña y que se evidenciaron evidencias de validez.(AU)

A Novel Standard for Systematic Reporting of Neuroblastoma Surgery: The International Neuroblastoma Surgical Report Form (INSRF): A Joint Initiative by the Pediatric Oncological Cooperative Groups SIOPEN∗, COG∗∗, and GPOH∗∗∗.

OBJECTIVE: To create the first structured surgical report form for NBL with international consensus, to permit standardized documentation of all NBL-related surgical procedures and their outcomes. SUMMARY OF BACKGROUND DATA: NBL, the most common extracranial solid malignant tumor in children, covers a wide spectrum of tumors with significant differences in anatomical localization, organ or vessel involvement, and tumor biology. Complete surgical resection of the primary tumor is an important part of NBL treatment, but maybe hazardous, prone to complications and its role in high-risk disease remains debated. Various surgical guidelines exist within the protocols of the different cooperative groups, although there is no standardized operative report form to document the surgical treatment of NBL. METHODS: After analyzing the treatment protocols of the SIOP Europe International Neuroblastoma Study Group, Children's Oncology Group, and Gesellschaft fuer Paediatrische Onkologie und Haematologie - German Association of Pediatric Oncology and Haematology pediatric cooperative groups, important variables were defined to completely describe surgical biopsy and resection of NBL and their outcomes. All variables were discussed within the Surgical Committees of SIOP Europe International Neuroblastoma Study Group, Children's Oncology Group, and Gesellschaft fuer Paediatrische Onkologie und Haematologie - German Association of Pediatric Oncology and Haematology. Thereafter, joint meetings were organized to obtain intercontinental consensus. RESULTS: The "International Neuroblastoma Surgical Report Form" provides a structured reporting tool for all NBL surgery, in every anatomical region, documenting all Image Defined Risk Factors and structures involved, with obligatory reporting of intraoperative and 30 day-postoperative complications. CONCLUSION: The International Neuroblastoma Surgical Report Form is the first universal form for the structured and uniform reporting of NBL-related surgical procedures and their outcomes, aiming to facilitate the postoperative communication, treatment planning and analysis of surgical treatment of NBL.

The integration of mental health care act in primary care: an audit of the use of mental health care act forms for patients´ admission and the effect of continuing medical education on health professionals´ performance of usage, based on Letsholathebe II Memorial Hospital´s experience, in Maun, Botswana.

INTRODUCTION: despite the adoption of mental disorders act in 1972, the use of required mental health care act (MHCA) forms during admission of patients with mental illnesses remained below the legal expectation in the Maun District Hospital. This study audited Letsholathebe II Memorial Hospital (LIIMH) professionals´ usage of MHCA forms. METHODS: this was a quasi-experimental study that audited files of patients admitted with mental illnesses, before, three and six months after a continuing medical education (CME). Cochran Q, McNemar symmetry Chi-square were used for comparison of performance. RESULTS: of the 239 eligible files, we accessed 235 (98.3%). About two in ten (n=36/235, 15.3%) MHCA forms were not used in combination with required forms. The quasi-majority of MHCA forms set used, aligned with involuntary admission (n=134/137, 97.8%). Required admission MHCA forms significantly increased from nil before continuing medical education (CME-0), to 64.6% (n=51/79) at CME-3 and 77% (n=59/77) at CME-6 (p<0.001). However, there was no statistical difference between the last two periods (64.6% vs 77%, p=0.164). Voluntary admission remained below 13% (n=10/79). Only six types of MHCA forms were used during this study. CONCLUSION: there was no adequate use of required MHCA forms at LIIMH before CME. Thereafter, the proportion of adequate use increased from period CME-0 to the periods CME-3 and CME-6. However, there was no difference in proportion between the last two periods. We recommend an effective and regular CME twice a year for health professionals on selected MHCA forms.

Preparation and Practice of the Necessary Documents in Hospital for the "Act on Decision of Life-Sustaining Treatment for Patients at the End-of-Life".

PURPOSE: Six forms relating to decisions on life-sustaining treatment (LST) for patients at the end-of-life (EOL) in hospital are required by the "Act on Decision of LST for Patients at the EOL." We investigated the preparation and creation status of these documents from the database of the National Agency for Management of LST. MATERIALS AND METHODS: We analyzed the contents and details of each document necessary for decisions on LST, and the creation status of forms. We defined patients completing form 1 as "self-determined" of LST, and those whose family members had completed form 11/12 as "family decision" of LST. According to the determination subject, we compared the four items of LST on form 13 (the paper of implementation of LST) and the documentation time interval between forms. RESULTS: The six forms require information about the patient, doctor, specialized doctor, family members, institution, decision for LST, and intention to use hospice services. Of 44,381 who had completed at least one document, 36,693 patients had form 13. Among them, 11,531, 10,976, and 12,551 people completed forms 1, 11, and 12, respectively. The documentation time interval from forms 1, 11, or 12 to form 13 was 8.6±13.6 days, 1.0±9.5 days, and 1.5±9.7 days, respectively. CONCLUSION: The self-determination rate of LST was 31% and the mean time interval from self-determination to implementation of LST was 8.6 days. The creation of these forms still takes place when the patients are close to death.

Innovative standardized reporting template for prostate mpMRI improves clarity and confidence in the report.

PURPOSE: The goal of the current study was to evaluate the effect of a standardized prostate mpMRI reporting template on urologists' understanding and confidence in counselling a patient on the results of the MRI. To do this we performed a survey study to assess the understanding and confidence of urologists reviewing reports prior to (pre) and after (post) adoption of a standardized mpMRI template. METHODS: Six urologists reviewed ten pre- and post- mpMRI templated reports and completed a survey to assess the clarity of key elements and the confidence in counseling the patient. The urologists were blinded to the study objective. Nonparametric constrained permutation test for significance was performed to compare the results prior to and after implementation of the template. RESULTS: 29 pre- and 30 post-template mpMRI reports were reviewed. The average score for the post-template reports was significantly higher (10.7 ± 0.6 vs 7.5 ± 2.7 [ p< 0.001]) regardless of the reviewer. Urologists were also overall more confident in counselling patients when the standardized mpMRI reporting template had been used. CONCLUSION: Implementation of a standardized template for reporting of prostate mpMRI findings resulted in improved clarity and confidence in counselling patients. Radiologists should consider implementing a standardized reporting template to improve clinicians' understanding and confidence of the report.

A Novel Method Enables General Pathologists to Create Web Dynamic Forms for Synoptic Tumor Reporting.

CONTEXT.­: Tumor reporting constitutes a significant daily task of pathologists. An efficient tumor-reporting methodology is thus vitally important. The Web dynamic form (WbDF) method offers a multitude of advantages over the prevailing transcription-mediated reporting method based on static-text checklists. However, its adaptation has been severely hampered for 2 decades by its costly needs to maintain a complex back-end system and to change the system for frequent updates of reporting content. OBJECTIVE.­: To overcome these 2 obstacles with a serverless Web platform that enables users to create, customize, use, and download WbDFs as synoptic templates for structured tumor reporting. DESIGN.­: Deploy ReactJS as a Web platform. Create form components in JavaScript Object Notation files. Use JavaScript Object Notation files to make WbDFs on the Web platform. Use the WbDFs to generate final pathology reports. RESULTS.­: Ordinary users (pathologists) can create/customize reporting templates as WbDFs on the Web platform. The WbDF can be used to make a pathology report and stored/shared like ordinary document files. There is no back-end system to change, nor a requirement for computer programming skills. CONCLUSIONS.­: This strategy eliminates the need for a complex back-end system and the associated cost when updating tumor-reporting standards, making it possible to adopt the WbDF method without the technological drawbacks associated with content updates. It also opens a new field of how the tumor-reporting system should be organized, updated, and implemented.

Standardization of Burn Patients Transfer: Implementation of a Transfer Request Form to Israel's National Burn Center.

BACKGROUND: Burn injuries are an extreme form of traumatic injury and are a global health issue. The Israeli National Burn Unit at the Sheba Medical Center, a tertiary level 1 trauma center and hence the national referral center, treats burn patients admitted both directly and referred from other medical centers. The transfer and handover of patients is a critical step in patient care. In Israel, to date, there is no standardized and accepted transfer request form for burn patients from one medical facility to another. OBJECTIVES: To construct a transfer request form to be used in all future burn patient referrals. METHODS: After reviewing publicly available international transfer forms and comparing them to the admission checklist used at our unit, a structured transfer request form was constructed. RESULTS: After a pilot study period, testing the form in various scenarios and adapting it, the first standardized transfer form for burn patients in Israel in both English and Hebrew was implemented beginning May 2020. CONCLUSIONS: Implementation of a standardized transfer process will improve communication between healthcare professionals to help maintain a continuum of care. We believe that implementation of a burn transfer form in all future referrals can standardize and assure better care for burn patients, thus improving overall patient care.

Outpatient vascular clinic management in COVID-19 pandemic.

INTRODUCTION: The recent Sars-CoV2 pandemic has dramatically slowed patients' access to our clinic for vascular pathology when the contagion curve peaked. The need to restore the assistance activity has led us to adopt new individual prophylaxis and hygiene measures. METHODS: Doctors and staff must wear dedicated clothes. Mask and gloves are mandatory for patients. A visit is scheduled every 60 minutes to allow the sanitation of the rooms. The day before the visit patients are contacted by telephone for the Covid-19 risk triage. In the presence of symptoms the visit is postponed. In the presence of other risk factors a IgG/IgM Rapid Test for Covid-19 is performed on admission to the clinic. In the presence of fever, if an extraordinary rapid test cannot be performed, the visit must be postponed. Rapid test positive patients cannot be visited: they are placed in solitary confinement at their home waiting for a nasopharyngeal swab for Covid-19. When the rapid test is positive, immediate room sanitation also occurs. The rooms dedicated to the outpatient clinic as well as medical and not medical instruments are disinfected. CONCLUSION: The one adopted can be a useful management model for any type of care activity in order to guarantee the safety of patients and all the staff. KEY WORDS: COVID-19, Management, vascular, Outpatient clinic.

The Global Consortium Study of Neurological Dysfunction in COVID-19 (GCS-NeuroCOVID): Development of Case Report Forms for Global Use.

Since its original report in January 2020, the coronavirus disease 2019 (COVID-19) due to Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) infection has rapidly become one of the deadliest global pandemics. Early reports indicate possible neurological manifestations associated with COVID-19, with symptoms ranging from mild to severe, highly variable prevalence rates, and uncertainty regarding causal or coincidental occurrence of symptoms. As neurological involvement of any systemic disease is frequently associated with adverse effects on morbidity and mortality, obtaining accurate and consistent global data on the extent to which COVID-19 may impact the nervous system is urgently needed. To address this need, investigators from the Neurocritical Care Society launched the Global Consortium Study of Neurological Dysfunction in COVID-19 (GCS-NeuroCOVID). The GCS-NeuroCOVID consortium rapidly implemented a Tier 1, pragmatic study to establish phenotypes and prevalence of neurological manifestations of COVID-19. A key component of this global collaboration is development and application of common data elements (CDEs) and definitions to facilitate rigorous and systematic data collection across resource settings. Integration of these elements is critical to reduce heterogeneity of data and allow for future high-quality meta-analyses. The GCS-NeuroCOVID consortium specifically designed these elements to be feasible for clinician investigators during a global pandemic when healthcare systems are likely overwhelmed and resources for research may be limited. Elements include pediatric components and translated versions to facilitate collaboration and data capture in Latin America, one of the epicenters of this global outbreak. In this manuscript, we share the specific data elements, definitions, and rationale for the adult and pediatric CDEs for Tier 1 of the GCS-NeuroCOVID consortium, as well as the translated versions adapted for use in Latin America. Global efforts are underway to further harmonize CDEs with other large consortia studying neurological and general aspects of COVID-19 infections. Ultimately, the GCS-NeuroCOVID consortium network provides a critical infrastructure to systematically capture data in current and future unanticipated disasters and disease outbreaks.

Society for Maternal-Fetal Medicine Special Statement: A maternal transport briefing form and checklist.

When performing a maternal transport between two facilities, numerous pieces of information must be communicated between physicians, nurses, and transport personnel, including the health status of 2 patients (mother and fetus), availability of bed space and personnel in 2 units at the receiving facility (labor and delivery unit and neonatal intensive care unit), arrangements for transportation, and inpatient and outpatient records. The amount and complexity of information creates a risk of medical error due to communication lapses. A cognitive aid such as a standardized form can help the team prepare for a transfer and provide a consistent framework for a handoff briefing among healthcare professionals. SMFM presents a sample briefing form to ensure that key elements are communicated for every maternal transport. Practical suggestions are given to help facilities customize the form and implement it on their units.

[Contact tracing in patients infected with SARS-CoV-2. The fundamental role of Primary Health Care and Public Health]. / Estudio de contactos en infectados por SARS-CoV-2. El papel fundamental de la Atención Primaria y de la Salud Pública.

The aim of this study was to promote the rapid identification of the contacts of patients infected with SARS-CoV-2 and therefore the control of the pandemic. Different methodologies and recommendations on contact tracing for Primary Health Care (PHC) and Public Health Services (PHS), like articles in Pubmed about COVID-19 and contact tracing, official contact definitions, the classic contact tracing model in tuberculosis (TB), information about apps for contact tracing and the role of the diagnostic tests, were reviewed. To establish efficient prevention and control measures, it is always necessary to implement contact tracing based on clinical suspicion, early diagnosis and isolation of cases and contacts and their follow-up. The classic contact tracing model in TB can be applied to this new infection, but accelerating the process given its acute nature and its potential severity. Good coordination between PHC and PHS and having sufficient resources is essential.

Compliance of hand written transfusion requisition form and improvement after online request - a clinical audit.

OBJECTIVE: To assess the compliance of healthcare personnel with regard to sending completely filled transfusion requisition forms. METHODS: The audit was conducted at Aga Khan University Hospital, Karachi, and comprised requisition slips received at the hospital blood bank from September 2014 to February 2015. The British Committee for Standards in Haematology guidelines was used as the standard. Percentage of each variable on the proforma was analsyed. Rating <50% for each form was defined as "needs improvement", 51-99% as "good compliance" and 100% as "excellent compliance". After implementing strategies to increase awareness and the launching of an online transfusion requisition form, a re-audit of physician compliance was done from February to April 2016 and the results were compared with the initial audit.. Data was analysed using SPSS 21. RESULTS: The audit and the re-audit both comprised 1000 transfusion requisition forms each. In the audit, The sum of total scores of all the transfusion requisition forms was 4911, indicating a compliance rate of 46.9%, while the corresponding numbers in the re-audit were 10000 and 100%. CONCLUSIONS: The implementation of online blood transfusion requisition system had a positive impact on compliance rate.

Syringomyelia and Chiari Syndrome Registry: advances in epidemiology, clinical phenotypes and natural history based on a North Western Italy cohort.

BACKGROUND: Syringomyelia and Chiari Syndrome are classified as rare diseases, but current known occurrence in Europe is missing. The increased ability to diagnose these pathologies by magnetic resonance imaging and its widespread availability has led to an increase of reported cases, often asymptomatic, with the need to standardize definitions, diagnostic criteria and treatments. AIMS: We present shared Interregional Recommendations developed with the primary aim to estimate Syringomyelia and Chiari Syndrome prevalence and incidence in North Western Italy, with special reference to symptomatic forms. METHODS: An agreement for the standardization of definitions, classifications, diagnostic criteria and surgical Recommendations was reached by the multidisciplinary Interregional Piemonte and Valle d'Aosta Chiari-Syringomyelia Consortium (Delphi method); next, in 2011 a census for Syringomyelia and Chiari Malformation was performed through the Interregional Piemonte and Valle d'Aosta Rare Disease Registry, integrated by a dedicated form in order to estimate prevalence and incidence. RESULTS: 436 patients, 292 females, met shared interregional diagnostic criteria. Syringomyelia prevalence was estimated in 4.84:100 000; Chiari Malformation prevalence was 7.74:100 000; incidence was 0.82:100 000 and 3.08:100 000 respectively. Demographics, neuroradiological parameters and aetiology were reported (in symptomatic and asymptomatic forms). Finally, symptoms and signs, familiar and natural history were analyzed. CONCLUSIONS: First Italian epidemiological data (prevalence, incidence) on Chiari and syringomyelia was collected, according to shared diagnostic Recommendations. Future perspectives include the adoption of these Recommendations at national level to standardize the access to diagnosis and care process and promote multicenter clinical trials.

Issues Impacting Adverse Event Frequency and Severity: Differences Between Randomized Phase 2 and Phase 3 Clinical Trials for Lasmiditan.

OBJECTIVE: We explore factors that may have contributed to differences in treatment-emergent adverse events in the phase 2 and phase 3 lasmiditan clinical trials. BACKGROUND: Phase 2 and phase 3 trials showed that the centrally penetrant 5-HT1F agonist, lasmiditan, was effective; higher frequency and severity of adverse events (AEs) were seen in phase 2. METHODS: This work represents a hybrid of a review of primary documents and study reports with additional post hoc analyses. Protocols, informed consents, data collection forms, and methodologies were reviewed. This information was supplemented by results from the clinical study reports and post hoc analyses of individual patient data from each trial. RESULTS: For lasmiditan 100 and 200 mg, in phase 2, the incidence of ≥1 AE was 72-86% (26% severe), while in phase 3 was 36-43% (2% severe). The most common AEs in all studies were CNS-related. The phase 2 consent form was more descriptive of AEs than phase 3. In phase 2, patients recorded AEs and severity in a paper diary that warned about drowsiness and dizziness. In phase 3, patients recorded in electronic diaries whether they experienced unusual feelings after dosing with lasmiditan that they had not felt with a migraine before, and were contacted to determine if an AE had occurred. In phase 2, the AE Schwindel was variably translated from German as "vertigo" or "dizziness," while phase 3 vertigo cases were queried to ensure there was a sensation of rotation or movement. History of recurrent dizziness and/or vertigo was exclusionary in phase 3. CONCLUSIONS: This work illustrates how informed consent wording, AE collection methods, translation, exclusion criteria, and other factors may be important determinants for reporting of the frequency and severity of AEs in clinical trials.