The Medical Science Liaison Role in Spain: Opinion of the Commercial Department Personnel.

INTRODUCTION: The Medical Science Liaison (MSL) works in a cross-functional way, especially with the commercial department. The aim of the present study was to evaluate the knowledge of these positions about the MSL role in their companies and describe the grade of internal interaction between them in daily practice. METHODS: An online survey was completed by 151 employees from commercial departments between January and April 2020. It consisted of 29 or 31 items, depending on answers. RESULTS: Of participants, 22.5% and 77.5% occupied management or non-management positions, respectively. Most respondents stated that the MSL role belongs primarily to the medical department (94.6%), considered important that promotional materials are elaborated or supported by the medical department (95.4%), highlighted the importance of sharing their daily activity with MSLs (77.8%) and vice versa (89.3%). The most valuable activity of MSLs was clinical sessions (55.3%), followed by speaker briefings (16.0%), and data discussions (14.7%). Most useful activities of MSLs for participant's day to day were external training (sessions to healthcare providers, HCPs, 34.9%), support of key opinion leaders' (KOLs) unmet needs (22.1%), and feedback from fieldwork aimed at redefining new strategies of the company (15.4%). The mean overall assessment (0-10) of the MSL was 8.1. CONCLUSION: The MSL represents a key role inside pharmaceutical and biotechnological companies, providing scientific value. The members of the commercial departments interact with the MSL on a daily basis and consider that it is a strategic position with a great future that adds value within the company.

The Medical Science Liaison Role in Spain: A Survey Capturing the Opinion of Medical Department Professionals.

BACKGROUND: Literature that addresses the role of Medical Science Liaison (MSL) is currently limited. To the best of our knowledge, this is the first survey in Spain that gathers opinions from professionals whose work is either in or related to the medical departments from pharmaceutical companies. METHODS: A survey delivered by the SurveyMonkey online platform was completed by 101 pharmaceutical industry professionals (medical advisor/manager, 31.7%; medical director, 26.7%; medical information, 12.9%; and MSL manager, 11.9%). RESULTS: The median score for the global impression of the MSL was 8.7. The collaboration goes beyond formation since 85.1% of the respondents believed that MSLs should actively collaborate in both clinical trials and investigator-initiated studies, they should have more involvement with market access (51.5%), and they play an important role in compliance (94.0%). There was a tendency toward granting MSLs more responsibilities in terms of budget (73.3%) and their participation in the elaboration of the Medical Plan (91.1%). This position was considered as a strategic partner both internally and externally (76.2%). CONCLUSION: MSL is a well-known field-based profile with increasing importance and responsibilities. MSLs represent a strategic position as internal collaborators in the company, whose success relies on cross-functional work. The MSL's profile is in constant development, currently facing challenges such as adapting to remote interactions, or providing a clear definition with the best metrics to measure their performance as a non-promotional position.

The medical science liaison role in Spain: A nationwide survey.

CONTEXT AND AIMS: The Medical Science Liaison's (MSL's) value to the company has evolved into a more strategic role with a wide variety of responsibilities. We conducted an online survey of current MSLs nationwide to assess their profile, activity development, performance evaluation, and career development. SUBJECTS AND METHODS: A 37-item survey was hosted on SurveyMonkey© and accessible from December 2018 to February 2019. The survey was open to current MSLs from different pharmaceutical companies in Spain and included questions about the participant profile, activity development, performance evaluation, and career development. STATISTICAL ANALYSIS USED: The results were expressed as valid percentages; to establish relationships between the answers to different questions, exclusion and comparison filters were used on the web platform. RESULTS: A total of 179 MSLs responded to the anonymous survey. Off-label information management (79%), relationships with key opinion leaders (76%), continuous medical training for HCPs (70%), involvement in clinical trials/investigator-initiated trials (68%), and elaboration of the National Strategy (67%) were mentioned as the top new competencies. Fifty-eight percent spend an average of 61%-80% of their time out in the field and 68% use remote interactions. Fifty-six percent did not agree that their current performance metrics are a reflection of their true value. Forty-five percent of the participants disagreed when asked if their activity is easily balanced with their personal lives. CONCLUSIONS: Based on our findings, we believe that there is a need to consider the MSL's strategic priorities, to define metrics that accurately assess MSL performance, and to find ways to fully maximize their limited time.

The Medical Science Liaison Role in Spain: A Survey About the Opinion of HealthCare Professionals.

PURPOSE/AIM: There are limited studies addressing the knowledge of healthcare professionals (HCPs) on the Medical Science Liaison (MSL) role. The objective of this study was to determine the percentage of HCPs that know the role, and to describe their opinion about the utility of the MSL activities on their clinical practice. METHODS: An online survey was completed by 107 HCPs between June 2019 and January 2020 through three Scientific Societies. It consisted of 17 or 25 questions, depending on the answers. RESULTS: Most HCPs (73.8%) knew the MSL role inside the pharmaceutical industry and were able to differentiate the MSL role from others in marketing/sales departments (77.6%). Support for research projects (70.8%) and training courses (68.1%) were the most valuable activities. Participants scored the credibility of data provided by the MSL with a mean of 7.5 (out of 10), and the added value that the MSL provides to their clinical practice with a mean of 6.9. Among HCPs unfamiliar with the role (26.2%), 60% of them are interested in meeting with the local MSL. CONCLUSION: Our study demonstrates that the MSL role is well-known by HCPs, mostly Key Opinion Leaders, and they agree on the importance of working together in scientific projects on, e.g., disease awareness, medical training, or clinical trials. Given the advance of targeted therapies and the move toward personalized medicine, the MSL role will be in more demand and necessary for HCPs in the years to come.

Clinical characterization of brief psychotic disorders triggered by the COVID-19 pandemic: a multicenter observational study.

This study aimed to characterize the clinical profile of patients with brief psychotic disorders (BPD) triggered by the psychosocial distress derived from the COVID-19 crisis. A multicenter study was conducted from March 14 to May 14, 2020 (the peak weeks of the pandemic in Europe). All consecutive patients presenting non-affective psychotic episodes with a duration of untreated psychosis of less than 1 month and whose onset was related to the COVID-19 crisis were recruited, but only those patients meeting Diagnostic Statistical Manual 5th edition (DSM-5) criteria for "BPD with marked stressors" (DSM-5 code: 298.8) during follow-up were finally included. Patients' sociodemographic and clinical characteristics were collected at baseline and summarized with descriptive statistics. During the study period, 57 individuals with short-lived psychotic episodes related to the emotional stress of the COVID-19 pandemic were identified, of whom 33 met DSM-5 criteria for "BPD with marked stressors". The mean age was 42.33 ± 14.04 years, the gender distribution was almost the same, and the majority were rated as having good premorbid adjustment. About a quarter of the patients exhibited suicidal symptoms and almost half presented first-rank schizophrenia symptoms. None of them were COVID-19 positive, but in more than half of the cases, the topic of their psychotic features was COVID-19-related. The coronavirus pandemic is triggering a significant number of BPD cases. Their risk of suicidal behavior, their high relapse rate, and their low temporal stability make it necessary to closely monitor these patients over time.

Hepatitis B virus sub-genotype A1 infection is characterized by high replication levels and rapid emergence of drug resistance in HIV-positive adults receiving first-line antiretroviral therapy in Malawi.

BACKGROUND: It has been proposed that hepatitis B virus (HBV) sub-genotype A1 infections have mild outcomes and a low risk of drug-resistance among patients infected with human immunodeficiency virus (HIV) receiving lamivudine-containing antiretroviral therapy (ART) without tenofovir in Africa. METHODS: The virologic expression of HBV sub-genotype A1 coinfection was studied over 12 months in HIV-positive adults starting stavudine/lamivudine/nevirapine in Malawi, using Sanger, deep, clonal, and single full-genome sequencing for the sensitive characterization of HBV resistance-associated mutations (RAMs). RESULTS: Among 1117 subjects, 133 (12%) tested HBsAg-positive. After starting ART, retention rates were 96/133 (72%) at 6 months and 54/133 (41%) at 12 months. Based upon the last available follow-up, 92/96 (96%) subjects achieved HIV-1 RNA <40 copies/mL, 48/96 (50%) showed HBV DNA <14 IU/mL, and 24/96 (25%) acquired HBV RAMs. At 6 months, M204I was detected in 8/46 (17%) and 16/17 (94%) subjects using Sanger and deep sequencing, respectively. At 12 months, all viremic patients had multiple resistance and compensatory mutations coexisting on the same HBV genomes. Comparing HBeA-positive (67/133, 50%) with HBeAg-negative subjects, 64/67 (96%) vs 35/66 (55%) showed baseline HBV DNA >2000 IU/mL (P = .0006), 39/47 (17%) vs 9/49 (82%) had persistent HBV DNA detection during follow-up (P < .0001), and 23/47 (49%) vs 2/49 (4%) acquired HBV RAMs (P < .0001). Baseline HBV DNA levels were median 8.1 vs 5.3 log10 IU/mL in subjects with vs those without treatment-emergent RAMs (P < .0001). CONCLUSIONS: HBV sub-genotype A1 infections showed a severe virologic expression in HIV-positive Malawians. The findings strengthen the urgency of interventions to improve ascertainment and management of chronic hepatitis B in the region.

Illness beliefs about cancer among healthy adults who have and have not lived with cancer patients.

BACKGROUND: Illness representations have been proposed as key determinants for facing health risks and managing disease, and consequently for health outcomes. PURPOSE: This study aims to know and compare non-specialised illness representations of cancer among adults who had not suffered from cancer and who had/had not lived with cancer patients. METHOD: The revised Illness Perception Questionnaire was adapted to assess illness perceptions among healthy people. Cancer representations were explored in a community-based sample of adults of both genders from different educational backgrounds and who had differing experience with cancer, none being a patient. RESULTS: The participants' beliefs about cancer included both biomedical and folk knowledge. Compared to age, sex, and educational level, family experience with cancer (having lived or not with a patient) had the strongest impact on the contents of the representations on cancer. Further, people with a family experience with the disease, compared to those not having a relative diagnosed with cancer, reported significantly more symptoms and stronger emotional impact. CONCLUSIONS: This study allowed us to establish the perceptions on cancer of non-patients with no specialised knowledge. Findings may help in designing and implementing tailored preventive interventions taking into account family experience with the disease, as well as interventions aimed at enhancing family and social care and support given to cancer patients.

Postoperative bilateral adrenal hemorrhage: correlation between clinical and radiological signs.

The case of a patient who developed progressive hemodynamic instability during the late postoperative period following oncologic abdominal surgery is presented. Suspecting the onset of intraabdominal infection, we ordered a computed tomographic scan of the area, on which bilateral adrenal hemorrhage was observed. Adrenal function tests confirmed the presence of adrenal insufficiency.

Human StarD5, a cytosolic StAR-related lipid binding protein.

Recently identified StarD5 belongs to the StarD4 subfamily, a subfamily of steroidogenic acute regulatory related lipid transfer (START) domain proteins that includes StarD4 and StarD6, proteins whose functions remain unknown. The objective of this study was to confirm StarD5's protein localization and sterol binding capabilities as measures to pursue function. Using rabbit polyclonal antibody against newly purified human histidine-tagged/StarD5 protein, StarD5 was detected in human liver. In parallel studies, increased expression of StarD5 in primary hepatocytes led to a marked increase in microsomal free cholesterol. Cell fractionation studies demonstrated StarD5 protein in liver cytosolic fractions only, suggesting StarD5 as a directional cytosolic sterol carrier. Supportive in vitro binding assays demonstrated a concentration-dependent binding of cholesterol by StarD5 similar to that of the cholesterol binding START domain protein StarD1. In contrast to selective cholesterol binding by StarD1, StarD5 bound the potent regulatory oxysterol, 25-hydroxycholesterol, in a concentration-dependent manner. StarD5 binding appeared selective for cholesterol and 25-hydroxycholesterol, as no binding was observed for other tested sterols. The ability of StarD5 to bind not only cholesterol but also 25-hydroxycholesterol, a potent inflammatory mediator and regulatory oxysterol, raises basic fundamental questions about StarD5's role in the maintenance of cellular cholesterol homeostasis.

Random amplified polymorphic DNA profiles as a tool for the identification of Acanthamoeba divionensis.

In the present study, we demonstrated the Random Amplified Polymorphism DNA (RAPD) diagnostic validity. In our study, we have analyzed RAPD profiles searching for characteristic and useful bands for Acanthamoeba diagnosis at the species level. We found a distinctive 370-bp band in A. divionensis RAPD patterns, using the OPC14 primer (TGCGTGCTTG) (Operon Technologies, Inc., Alameda, CA). The band specificity was confirmed by hybridization, using it as a probe, against all OPC14 amplifications from 10 different Acanthamoeba species. Once we sequenced this band, we used it to design a specific primer pair which showed positive amplification only in A. divionensis isolates.

Antigenicity of Leishmania braziliensis histone H1 during cutaneous leishmaniasis: localization of antigenic determinants.

The humoral immune response against Leishmania braziliensis histone H1 by patients with cutaneous leishmaniasis is described. For this purpose, the protein was purified as a recombinant protein in a prokaryotic expression system and was assayed by enzyme-linked immunosorbent assay (ELISA) with a collection of sera from patients with cutaneous leishmaniasis and Chagas' disease. The assays showed that L. braziliensis histone H1 was recognized by 66% of the serum samples from patients with leishmaniasis and by 40% of the serum samples from patients with Chagas' disease, indicating that it acts as an immunogen during cutaneous leishmaniasis. In order to locate the linear antigenic determinants of this protein, a collection of synthetic peptides covering the L. braziliensis histone H1sequence was tested by ELISA. The experiments showed that the main antigenic determinant is located in the central region of this protein. Our results show that the recombinant L. braziliensis histone H1 is recognized by a significant percentage of serum samples from patients with cutaneous leishmaniasis, but use of this protein as a tool for the diagnosis of cutaneous leishmaniasis is hampered by the cross-reaction with sera from patients with Chagas' disease.