Medical Information Department Research Articles

Optimizing patient (pt) care through pt-focused resources to prevent and manage hand-foot skin reaction (HFSR).

e24144 Background: Research has shown that pts and caregivers (non-HCPs) seek medical and disease-related information more than once a month, and this has accelerated due to the COVID-19 pandemic. However, they find it difficult to understand the information they receive and thus, can be misinformed. By understanding the use of fair-balanced medical information (MI) resources by non-HCPs, pharmaceutical companies can develop scientifically accurate yet pt-friendly resources to meet their needs (Goettner, 2022; Rai, 2022). Upon reviewing the unsolicited oncology inquiries received by our MI department, approximately 25% of inquiries were from non-HCPs seeking information. Over the past 3 years, non-HCPs have submitted almost 10,000 inquiries regarding our oncology products, in which 191 inquiries were specifically regarding HFSR and regorafenib and sorafenib. Historically, our MI department responded to non-HCP inquiries by sharing the product label information. However, we identified an unmet need for trustworthy, comprehensive, and accurate pt resources in plain language. Methods: A full literature review was performed, and the relevant data were summarized in plain language for pts. Both HCPs and pts participated in developing the global pt resource on the prevention and management of HFSR for regorafenib and sorafenib. The seven-page interactive brochure was written in 4th to 6th grade reading level which included images and graphics to enhance the understanding of data, easy navigation to the content of interest, and glossary to define key terms. Furthermore, these materials were translated for pts who participated in the regorafenib and sorafenib Patient Support Program in Brazil to further educate and support pts who have started therapy. Results: As of June 2023, the global pt medical resource has been deployed 28 times in Brazil, delivering key information to non-HCPs on their disease and treatment while emphasizing its practical utility and addressing health literacy challenges. We collected feedback from pts who utilized the translated material, and they described it to be “informative” and “helpful” since it empowered them to effectively navigate and address HFSR-associated discomforts during their treatment journey. The feedback has also been utilized to further enhance the resource’s feasibility. Conclusions: The pt feedback on the brochures showcases the value of pt-focused approach in oncology and the positive impact of collective efforts across all stakeholders including pts, pharmaceutical MI departments and pt programs. Furthermore, it demonstrates how MI can bridge the gap between pt insights and clinical knowledge by addressing their needs and providing practical and trustworthy tools. Not only does this initiative enhance pt understanding but also empowers pts to take a more active role in their treatment and fosters shared-decision making.

An Update from the Benchmark Survey of phactMI™ Member Companies on Providing Medical Information in the Digital Space

ObjectiveThe Pharma Collaboration for Transparent Medical Information (phactMI™) benchmarking survey of 32 pharmaceutical companies describes the use of technology by Medical Information Departments.MethodsA survey was distributed to phactMI™ member companies in June 2022 and included 79 closed and open-ended questions. The survey’s six sections included demographics, chatbot, social media, instant messaging applications, websites, and technology.ResultsMost Medical Information Departments have implemented innovative technology since 2019 with the main driver of remaining up-to-date. A total of 94% have a Medical Information website. Of those with a Medical Information website for healthcare professionals (HCPs), 97% allow for self-authentication. Most HCP-based websites have webforms for inquiries and 1–800 numbers, while only few offer video chat, chatbot, and the ability to identify local representatives. These websites also link to clinicaltrials.gov, publications, posters, and congress materials. Only 30% have a website for patients/caregivers. Most websites are discoverable by Google™. Awareness of Medical Information Websites occurs in a variety of ways, with most using multiple strategies to reach HCPs. There is wide variation in the technology platform used for the core functions of Medical Information.ConclusionAs technology continues to advance and omnichannel content remains a key objective, Medical Information needs to remain agile and transformative in their strategic and tactical planning and execution. Based on this benchmarking survey, the authors recommend that Medical Information Departments focus on expanding services for patients/caregivers, leverage digital innovations, expanding awareness, building efficiencies in workflow through technology, and continually improving website functionalities with innovative technologies.

Development of Learning Media Using the Powtoon Application for Effective Communication Courses in Diploma 3 Medical Record and Health Information Department

Communication between health workers and patients is still a major problem in health services. Learning media are needed that can be used by students of medical records and health information to improve effective communication. The purpose of this research is to develop effective communication learning video media using the Powtoon application. This research method uses the ADDIE product development model. Validation of the development of learning video media through learning media expert tests and expert tests for Effective Communication subject matter. Test the effectiveness of learning media through pre-test and post-test on 70 students. The results of the learning media expert test from 4 learning videos averaged 95.42% (very feasible) and the lecture material test from Effective Communication course lecturers averaged 95.90 (very feasible). The results of the analysis of the pre-test average value of 78 and the post-test average value of 92.71. Through Paired t-test: Result = 0.000. Meaning: There is a difference between before and after treatment (learning using videos). Reason: The p value < 0.05 (95% confidence).

Effects of combination therapy with Shenfu Injection in critically ill patients with septic shock receiving mechanical ventilation: A multicentric, real-world study.

Background: Septic shock has increasingly become a cause of death threatening human survival. Shenfu Injection (SFI), a patented Chinese medicine, has been widely used in the treatment of patients with sepsis and cardiovascular diseases domestically. We sought to examine whether combination therapy with SFI can improve clinical outcomes in critically ill patients undergoing mechanical ventilation (MV). Methods: This real-world, multicenter retrospective trial enrolled consecutive adult patients with sepsis requiring MV from four medical/surgical intensive care units (ICUs) in China between August 2016 and September 2021. Patients were identified from the medical information department database of each center and assigned to either of two groups (SFI or control) on the basis of the initial treatment received. The primary outcome was 28-day all-cause mortality, and the durations of vasopressor therapy and MV, the ICU length of stay, and costs were assessed as secondary outcomes. Subsequently, we performed a meta-analysis of randomized controlled trials (RCTs) on SFI published before July 2021 to verify our conclusions. Results: 2311 mechanically ventilated patients with septic shock (1128 patients in the SFI group and 1183 in the control group) were analyzed. The survival probability during the first 28days after admission in the SFI group was greater than that in the control group [p < 0.01 by log-rank test; hazard ratio (HR), 0.56; 95% confidence interval (CI), 0.39-0.72]. Patients in the SFI group also experienced a significantly reduced duration of vasopressor therapy [7.28 (95% CI, 6.14-8.42) vs. 12.06 (95% CI, 10.71-13.41) days, p < 0.001], more ventilator-free days [6.49 (95% CI, 5.42-7.55) vs. 10.84 (95% CI, 9.59-12.09) days, p < 0.001], a shorter ICU length of stay [18.48 (95% CI, 17.59-19.38) vs. 23.77 (95% CI, 22.47-25.07) days, p < 0.001], and more time free from organ failure [14.23 (95% CI, 12.94-15.52) vs. 19.07 (95% CI, 16.09-22.05) days, p < 0.001]. No major adverse effects were reported in either group. Conclusion: Among critically ill patients requiring MV, combination therapy with SFI can improve the survival probability without any obvious adverse reactions.

Enregistrement informatique normalisé des actes de pharmacie clinique en établissement de santé : retour d’expérience et évaluation de la valorisation économique potentielle

Clinical pharmacy procedures are clearly defined by the French society of clinical pharmacy. However, clinical pharmacists do not have efficient tools for their traceability. This need has increased following the publication of the instruction on the day hospital management of patients. Indeed, the action of the clinical pharmacist is included in it. In order to improve our traceability of clinical pharmacy acts and to take advantage of the implementation of the instruction, we worked with the medical information department to integrate our activity into their business software and to model the pathways valued by the intervention of the clinical pharmacist in outpatient care and in day hospital.

Audit of Singleton Breech Delivery in a Tertiary Hospital

Background: The 2000 Term Breech Trial (TBT) demonstrated that planned caesarean section was safer for the 3-4% of pregnancies in which the fetus will be in the breech presentation at term. However, the approach to delivery has been a topic of interesting debate and heated controversy among obstetricians. Objectives: The aim of this study was to find out the incidence and perinatal outcome of singleton breech delivery at the University of Abuja Teaching Hospital, Abuja, and North-Central Nigeria. Methodology: This was a retrospective study of singleton breech deliveries managed at the University of Abuja Teaching Hospital between 1st January 2015 to 31st December 2019. Data on social-demographic characteristics, presentation, mode of delivery and neonatal outcome were obtained from the case notes retrieved from the Medical health information Department. Result: There were 287 singleton breech deliveries out of 10416 deliveries during the study period given an incidence rate of 2.8%. Majority of the women 265 (92%) were between 21-40 years with a mean age of 30.27 +/-5.66 years. There were 144 (50.2%) unbooked patients. Majority of the women 188 (65.5%) were multipara. About 108 (37.6%) of the babies were delivered as preterm. Assisted breech deliveries was conducted in 162 (56.44%) while 125 (43.55%) were via caesarean section with a caesarean section rate of 43.55%. The commonest indication for caesarean section was Breech plus previous uterine scar in 36 (28.8%). About 28 (9.8%) babies were born with low APGAR scores and had severe birth asphyxia. Majority of the babies, 23 (8.1%) delivered through assisted breech delivery suffered severe birth asphyxia compared to 3 (1.0%) babies who were delivered via caesarean section. Significant association was noted between route of delivery and perinatal outcome. Again, 77 (27.8) primigravidae had breech delivery in this study. About 9 (3.1%) babies delivered to these primigravidae had poor APGAR scores and suffered severe birth asphyxia. However, 8 (2.8%) babies were delivered through assisted vaginal delivery compared to 1 (0.3%) baby who was delivered through caesarean section. The test showed a significant association in perinatal outcome in primigravidae who were allowed to have assisted breech delivery with Chi-Square value of 50.551, df =2 and p-value of 0.0002 which is less than the significant level of 0.05. There were 41 perinatal deaths given a perinatal mortality rate of 143/1000. It was noted that 10 (3.5%) babies had intrauterine fetal death before delivery, while 31 (10.8%) occurred as fresh stillbirth and early neonatal death. About 26 (9.1%) of the perinatal were through assisted breech delivery and 5 (1.7%) were through caesarean section. The mean birth weight was 2.6 +/- 0.92 years. Maternal morbidities were associated with mothers who had caesarean section, this however was not significant. Conclusion: Breech delivery was common and was associated with high perinatal morbidity and mortality. Route of delivery has significant association with perinatal outcome. Careful case selection and skillful delivery protocol would ensure optimal perinatal outcome that will in turn reduce caesarean section rate and reduce the morbidities associated with caesarean section.

Research of Natural Health Products is Lacking – Right?

In May 1994, while working in marketing for BASF Pharmaceuticals in Germany, I was prescribed a product called Sinupret® for chronic sinusitis by my family physician. The product was behind the counter in the local pharmacy and was reimbursed by my health insurance. After some months, my sinusitis was gone and I was intrigued about the product, its regulation and most particularly the research behind it. In reading the Sinupret® packet I discovered to my surprise that it was a herbal medicine. Convinced, with my pharma background, that there would be little evidence for such a product I asked our medical information department to conduct a literature review of all clinical trials for herbal medicines in all languages. A week later I received 4 thick lever arch files of abstracts of tens of thousands of clinical trials on hundreds of products. This delivery changed my life!

Simulation of drug information skills in the medical information department

Purpose: To utilise DIcipher, an escape-room challenge, to provide a simulation of using drug information (DI) skills to answer drug questions in the medical information (MI) department within the pharmaceutical industry. Methods: The 15-minute challenge required the groups to solve one clue and retrieve DI questions about iron deficiency anaemia. DI resources were used to search for answers to unlock a box with the antidote. A debriefing session followed and a Likert scale survey was administered to obtain student perception. Results: A total of 15 second to fourth year pharmacy students at university participated in the challenge and completed the survey. No groups retrieved the antidote by answering all of the questions correctly. All students agreed that the challenge provided a realistic view of how to apply DI skills in an industry-based setting. Conclusion: This challenge demonstrated the function of a pharmacist in the MI department to pharmacy students.

Bilastine 10 and 20 mg in paediatric and adult patients: an updated practical approach to treatment decisions.

BackgroundBilastine, a non-sedating H1-antihistamine, is indicated to treat the symptoms of allergic disorders (e.g. rhinoconjunctivitis and urticaria) in adults and adolescents and, more recently, in children. Following its marketing approval, many questions regarding the ideal use of bilastine in various clinical practice situations have been received by the Medical Information Department (MID) of Faes Farma Spain. This article is an update of a previous review, with a focus on recent clinical information on the use of bilastine in paediatric and other populations.MethodsResults of recent clinical studies in paediatric and other populations as well as questions received and responses provided by the Faes Farma MID.ResultsThe information regarding the use of bilastine in paediatric patients is the most relevant aspect of this updated review. The stepwise approval of the paediatric formulations in various countries started with the European Medicines Agency approval in 2017 in accordance with a 2009 Paediatric Investigation Plan, followed by approval in other countries. The queries that are most commonly received by the Faes Farma MID include the potential for drug interactions involving bilastine and other frequently used drugs, and the use of bilastine in special populations or to treat specific symptoms related to allergic conditions. As the concomitant use of many medications is not permitted during clinical trials, the advice provided regarding the concomitant use of other medications with bilastine considers the pharmacological properties of both the drug in question and bilastine, as well as expert opinion. Likewise, advice regarding the use of bilastine in special populations (e.g. patients with renal impairment, obesity, lactose intolerance, and elderly or pregnant individuals) or to treat specific symptoms (e.g. treatment-resistant urticaria, pruritus or BASCULE syndrome) considers the best evidence from a variety of sources, including clinical studies, real-world experience, guideline recommendations and expert opinion.ConclusionThis updated review provides current data regarding the best use of bilastine in specific situations and patients and identifies areas in which further knowledge is required. Although decisions regarding the use of bilastine may be aided by expert opinion that relies on knowledge of the underlying science, additional research and evidence are required to answer certain queries regarding the use of bilastine.

Preferences for Accessing Medical Information in the Digital Age: Health Care Professional Survey.

BackgroundHealth care professionals (HCPs) routinely have questions concerning the medications they are recommending. There are numerous resources available; however, each has its own advantages and disadvantages.ObjectiveThe purpose of this survey was to gain knowledge of the preferred methods and sources HCPs use to obtain information concerning medications.MethodsA total of 511 HCPs (202 physicians, 105 pharmacists, 100 advance practice nurses, 53 registered nurses, and 51 physician assistants) were surveyed through a third-party market research firm. All participants were practicing in the United States. Individuals working for a pharmaceutical company were excluded. The survey collected demographics, frequency of searching medical information, types of questions searched, sources of medical information, and rationale for preferred and nonpreferred sources of medical information. Use of medical information resources were rated on a 5-point ordinal scale. Data were analyzed with descriptive statistics.ResultsOf the 511 respondents, 88.5% (452/511) searched for medical information either daily or several times per week. The most common questions involved dosing and administration, drug-drug interactions, adverse events and safety, clinical practice guidelines, and disease state information. The main rationale for using specific medical websites or apps and general online search engines frequently or very frequently was ease of use (medical websites or apps: 269/356, 75.6%; general online search engines: 248/284, 87.3%). Accuracy was the main rationale for frequent or very frequent use of medical literature search databases (163/245, 66.5%), prescribing labels or information (122/213, 57.3%), and professional literature (120/195, 61.5%). The main reason for rarely or never using specific medical websites or apps and medical literature search databases was unfamiliarity (medical websites or apps: 16/48, 33%; medical literature search databases: 35/78, 45%); for general online search engines, inaccuracy (34/54, 63%); and for prescribing labels or information and professional literature, excessive time (prescribing labels or information : 54/102, 52.9%; professional literature: 66/106, 62.3%). The pharmaceutical company was sometimes used as a resource for medical information. When the medical information department was used, the call center and the website were considered thorough and complete (call center: 14/25, 56%; website: 33/55, 60%). However, the rationale for not using the call center was the time required (199/346, 57.5%) and the website being unfamiliar (129/267, 48.3%).ConclusionsThe driving forces in the selection of resources are accuracy and ease of use. There is an opportunity to increase awareness of all the appropriate resources for HCPs which may aid in their daily clinical decisions. Specifically, pharmaceutical company medical information departments can help fulfill this need by addressing two major challenges with use of the pharmaceutical company: lack of awareness of medical information services and the speed at which responses are disseminated. Overall, there is lack of understanding or appreciation of the range of pathways to obtain published information and knowledge from pharmaceutical company medical information services. Among the many challenges resource champions will face are the ability to effectively make resources and their platforms accessible, known, and useful to the scientific community.

A survey on the structure, organization, and functions of medical information departments in the pharmaceutical industry in Spain

The medical information (MI) function within the pharmaceutical industry plays a significant role in the provision of scientific answers for patients and healthcare professionals. The purpose of this study is to identify the current structure, organization, and functions of MI departments in Spain. Sixty local and international pharmaceutical companies based in Spain were invited to participate in this study between May and July 2019. An online 34–item questionnaire developed by the AMIFE MI Working Group was distributed to the companies. Data were analyzed through descriptive statistics using response frequencies. A total of 44 responses from 60 surveys (73%) were received. More than half of the respondents were employed in international companies based in Europe (57%, n = 25). Seventy-one percent (n = 31) of the companies had 100 to 1,000 employees in Spain. Most respondents declared that they had an MI department in their company (73%, n = 32), with most (53%) having two to five employees working on MI. Most MI (n = 50) specialists had a biomedical academic degree (predominantly pharmacy, biology, and medicine). MI departments were involved in many functions, the most common being answering enquiries (100%), handling drug information requests (97%), preparing written responses (94%), and literature services for external use (77%). The mean annual volume of MI enquiries was 2,301 (median 1,100). The results of this survey contribute to a better understanding of MI departments in Spanish pharmaceutical companies, as well as their functions and responsibilities, and could help identify opportunities and areas for improvement.

A Deep Learning Framework for Automated ICD-10 Coding.

The International Statistical Classification of Diseases and Related Health Problems (ICD) is one of the widely used classification system for diagnoses and procedures to assign diagnosis codes to Electronic Health Record (EHR) associated with a patient's stay. The aim of this paper is to propose an automated coding system to assist physicians in the assignment of ICD codes to EHR. For this purpose, we created a pipeline of Natural Language Processing (NLP) and Deep Learning (DL) models able to extract the useful information from French medical texts and to perform classification. After the evaluation phase, our approach was able to predict 346 diagnosis codes from heterogeneous medical units with an accuracy average of 83%. Our results were finally validated by physicians of the Medical Information Department (MID) in charge of coding hospital stays.

Ceftriaxone compared with benzylpenicillin in the treatment of neurosyphilis in France: a retrospective multicentre study

Intravenous benzylpenicillin is the gold-standard treatment for neurosyphilis, but it requires prolonged hospitalisation. Ceftriaxone is a possible alternative treatment, the effectiveness of which remains unclear. We aimed to assess the effectiveness of ceftriaxone compared with benzylpenicillin in the treatment of neurosyphilis. We did a retrospective multicentre study including patients with neurosyphilis who were treated at one of eight tertiary care centres in France, from Jan 1, 1997, to Dec 31, 2017. We defined neurosyphilis as positive treponemal and non-treponemal tests and at least one of otic syphilis, ocular syphilis, either neurological symptom with a positive result on cerebrospinal fluid (CSF)-VDRL or CSF-PCR tests, or more than five leukocytes in a CSF cell count. Patients with neurosyphilis were identified from the medical information department database of each centre and assigned to one of two groups on the basis of the initial treatment received (ie, benzylpenicillin group or ceftriaxone group). The primary outcome was the overall clinical response (ie, proportion of patients with a complete or partial response) 1 month after treatment initiation. The secondary endpoints were proportions of patients with a complete response at 1 month and serological response at 6 months, and length of hospital stay. Of 365 patients with a coded diagnosis of neurosyphilis in one of the eight care centres during 1997-2017, 208 were included in this study (42 in the ceftriaxone group and 166 in the benzylpenicillin group). The mean age of patients was 44·4 years (SD 13·4), and 193 (93%) were men. We observed 41 instances of overall clinical response (98%) in the ceftriaxone group versus 125 (76%) in the benzylpenicillin group (crude odds ratio [OR] 13·02 [95% CI 1·73-97·66], p=0·017). After propensity score weighting, overall clinical response rates remained different between the groups (OR 1·22 [95% CI 1·12-1·33], p<0·0001). 22 (52%) patients in the ceftriaxone group and 55 (33%) in the benzylpenicillin group had a complete response (crude OR 2·26 [95% CI 1·12-4·41], p=0·031), with no significant difference after propensity score weighting (OR 1·08 [95% CI 0·94-1·24], p=0·269). Serological response at 6 months did not differ between the groups (21 [88%] of 24 in the ceftriaxone group vs 76 [82%] of 93 in the benzylpenicillin group; crude OR 1·56 [95% CI 0·42-5·86], p=0·50), whereas hospital stay was shorter for patients in the ceftriaxone group than for those in the benzylpenicillin group (mean 13·8 days [95% CI 12·8-14·8] vs 8·9 days [5·7-12·0], p<0·0001). No major adverse effects were reported in either group. Our results suggest that ceftriaxone is similarly effective to benzylpenicillin for the treatment of neurosyphilis, potentially decreasing the length of hospital stay. Randomised, controlled trials should be done to confirm these results. None.

The Drug Manufacturer as a Drug Information Resource.

Pharmacists use a myriad of drug resources for patient care; however, the drug manufacturer is often overlooked and underutilized as a resource for drug information. Pharmaceutical companies have a medical information department that is responsible for providing drug information to pharmacists and the public about the company's products. This article will explain the purpose and functions of the medical information department within a pharmaceutical company. In addition, the type of information that may be requested and the ways to request drug information will be discussed.

Markov chain analysis for the neonatal inpatient flow in a hospital.

Discrete-time Markov chain and queueing-theoretic models are used to quantitatively formulate the flow of neonatal inpatients over several wards in a hospital. Parameters of the models are determined from the operational analysis of the record of the numbers of admission/departure for each ward every day and the order log of patient movement from ward to ward for two years provided by the Medical Information Department of the University of Tsukuba Hospital in Japan. Our formulation is based on the analysis of the precise routes (the route of an inpatient is defined as a sequence of the wards in which he/she stays from admission to discharge) and their length-of-stay (LoS) in days in each ward on their routes for all neonatal inpatients. Our theoretical model calculates the probability distribution for the number of patients staying in each ward per day which agrees well with the corresponding histogram observed for each ward as well as for the whole hospital. The proposed method can be used for the long-term capacity planning of hospital wards with respect to the probabilistic bed utilization.

Where are We Now in Providing Medical Information in the Digital Space? A Benchmark Survey of PhactMI™ Member Companies.

The Pharma Collaboration for Transparent Medical Information (phactMI™) benchmarking survey was conducted to evaluate the use of technology and websites associated with the medical information (MI) departments of 27 biopharmaceutical companies in the United States. The e-survey was administered to phactMI™ members between December 2017 and February 2018 and included closed and open-ended questions with 7 distinct categories: existence of a MI website, content type available following a search query, website functions, search engine optimization (SEO), website traffic, internal communications/analytics, and additional technology capabilities. Survey findings noted that 20 companies own a MI-specific website through which MI services are provided to healthcare providers (HCPs). When asked about the dissemination of MI content through varying formats, survey results indicated Portable Document Format (PDF) to be the most common (18/27), followed by videos (8/27), presentations (5/27), infographics (3/27), and Hypertext Markup Language (3/27). Many companies have a responsive design website (19/25), webform (24/25), and a 1-800 number (22/25) for MI services. Few companies have a live chat (10/25) or a chatbot (1/25) and 9 of 25 said that content is searchable on Google™. Although website traffic varied among companies, a significant driver of this appeared to be whether the site is indexed. While most of the member companies have a MI website, there is significant room for improvement in content formats available as part of a search. Traditional website features, such as search functionality and webform, are commonly available on websites; however, newer technologies, such as chatbot and live chat, are less featured. Across most member companies, there is also a need for improvement in increasing website traffic, Google™ indexing, and SEO.

Association Between Use of Anticancer Drugs and Cardiovascular Disease-Related Hospitalization in Metastatic Colorectal Cancer: Insights From a Population-Based Study, the Anticancer Vigilance of Cardiac Events Study.

We aimed to investigate the association between use of anticancer drugs and cardiovascular-related hospitalization (CVRH) among patients with metastatic colorectal cancer (mCRC). A cohort study, the Anticancer Vigilance of Cardiac Events (AVOCETTE) Study, was conducted using data from the digestive tumor registry of a French county, the Département du Calvados. Incident mCRC cases diagnosed between 2008 and 2014 were included. The follow-up end date was December 31, 2016. Data from the county hospital center pharmacy and medical information departments were matched with the registry data. A competing-risks approach was used. Statistical tests were 2-sided. A total of 1,116 mCRC patients were included, and they were administered 12,374 rounds of treatment; fluorouracil, oxaliplatin, irinotecan, and bevacizumab were most common drugs used. A total of 208 CVRH events occurred in 145 patients (13.0%). The International Cancer Survival Standards type 1 standardized incidence was 84.0 CVRH per 1,000 person-years (95% confidence interval: 72.6, 95.5). Anticancer drugs were not associated with a higher incidence of CVRH. Male sex, increasing age, a prior history of CVRH, and a higher Charlson comorbidity index score were associated with a higher incidence of CVRH. CVRH was significantly associated with higher all-cause mortality (multivariable hazard ratio = 1.58, 95% confidence interval: 1.28, 1.95). In this study, anticancer drugs were not associated with a higher incidence of CVRH in mCRC patients.

Opinions and Trends of Healthcare Providers Concerning Scientific/Standard Response Documents.

One of the main roles of the medical information (MI) department within a pharmaceutical company is to develop scientific/standard response documents (SRDs) to provide comprehensive medical information to healthcare providers (HCPs). Thisstudy seeks to gain HCP feedback on the various elements in the format of an SRD. This study surveyed 400 healthcare providers (200 physicians, 100 pharmacists, and 100 nurse practitioners/advanced practice nurses and physician assistants) regarding their opinions and preferences on the structure, content, layout, and delivery options of SRDs. The survey also included questions assessing where HCPs access their medical information, their trust in the medical information they receive from MI Departments, and alternative methods for receiving medical information. HCPs often self-search for medical information via an electronic device, which allows for SRDs to serve as a key resource. HCPs, who had prior contact with a pharmaceutical company's MI department, have a high degree of trust in the SRDs that they had received. However, perception of bias can have an impact on their level of trust. HCPs prefer all relevant data such as real-world evidence, adverse drug reactions, and clinical trial data, while abstracts and data on file may not be needed, but the overall length should only be three to five pages. HCPs find value in various SRD formatting characteristics, such as charts, tables, and infographics. Overall, HCPs seek medical information resources, such as SRDs, to aid in the delivery of personalized patient care. HCPs prefer SRDs to be concise, but include comprehensive, unbiased medical information. Through HCP feedback, MI Departments of pharmaceutical companies can continue to develop and update their SRDs to increase uptake and potentially impact clinical practice.

Pharma Collaboration for Transparent Medical Information (phactMI™) Benchmark Study: Trends, Drivers, and Value of Product Support Activities, Key Performance Indicators, and Other Medical Information Services: Insights from a Survey of 27 US Pharmaceutical Medical Information Departments.

A benchmarking survey was conducted by the pharmaceutical collaboration for transparent Medical Information (phactMI™) consortium, with the goal to capture insights from the 27 member companies and their medical information organizations. phactMI™ Benchmarking Committee delivered an electronic survey to 27 United States (US) member companies' Medical Information (MI) departments between December 12, 2017 and February 20, 2018. The survey consisted of approximately 300 questions, divided into 9 topics which included multiple choice and open-ended questions about the following categories: medical information support provided based on different product lifecycles, key metrics measured to assess department performance, and other key services provided by medical information groups. The extent of MI product support varied across the lifecycle of a product. Most companies provided MI product support throughout the product lifecycle starting from investigational all the way through mature; however, the extent of activities varied. The top key performance indicators (KPIs) that were reported to senior leadership included response turnaround time (59%) and inquiry volume (48%). Among the 27 companies, 85% noted using customer satisfaction surveys administered via links within written response documents and 52% verbally via the company's call center. Other services with which MI groups noted most involvement included congress booth support (100%), insights/metric reporting (96%), and training the sales force on the MI function (74%). Additional services included payor support clinical pathway submissions (22%), presenting at advisory boards (22%), and competitive intelligence (26%). The results of this survey provide pharmaceutical MI groups with opportunities to consider services or activities that could enhance the support these groups provide to their customers and business partners.

Proposed Best Practice Guidelines for Scientific Response Documents: A Consensus Statement from phactMI.

The Medical Information Department of a pharmaceutical manufacturer provides written scientific responses to unsolicited requests from healthcare providers for information on products that extends beyond the product labeling (off-label). These scientific response documents are non-promotional, evidence-based, and scientifically balanced, conforming with internal pharmaceutical manufacturer's procedures and the Food and Drug Administration (FDA) Draft Guidance on Responding to Unsolicited Requests for Off-Label Information. Members of phactMI™ developed this proposal to offer best practices for content generation of scientific response documents. Scientific response documents review available literature to respond to an unsolicited request; therefore, they are similar in nature to systematic reviews. The sections and elements identified in this proposed best practice guidelines for scientific response documents are based on an adaptation of the sections and elements of systematic reviews. The sections of a scientific response document should include a restatement of the unsolicited request (title); a structured summary (abstract); approved indications, black box warnings, and background information when appropriate (introduction); the literature search information and study selection (methods); summation of data from clinical trials, meta-analysis, case reports, and/or real world evidence, as appropriate (results); treatment guidelines, if applicable and available (discussion); and references. Elements for each section should be included in a scientific response document as appropriate, as some elements are not necessary in some documents, based on the question. These elements were selected for inclusion to address any potential concerns of bias and transparency and reflect the intent that scientific response documents should be non-promotional, accurate, truthful, free of commercial bias, scientifically balanced, and evidence based.