El valor de p del test no es un ‘índice matemático’, es simplemente una frecuencia relativa / The p-value of the test is not a ‘mathematical index’, it is simply a relative frequency

Las revistas científicas más importantes en campos como medicina, biología y sociología publican reiteradamente artículos y editoriales denunciando que un gran porcentaje de médicos no entiende los conceptos básicos del análisis estadístico, lo que favorece el riesgo de cometer errores al interpretar los datos, los hace más vulnerables frente a informaciones falsas y reduce la eficacia de la investigación. Este problema se extiende a lo largo de toda su carrera profesional y se debe, en gran parte, a una enseñanza deficiente en estadística que es común en países desarrollados. En palabras de H. Halle y S. Krauss, ‘el 90% de los profesores universitarios alemanes que usan con asiduidad el valor de p de los test no entiende lo que mide ese valor’. Es importante destacar que los razonamientos básicos del análisis estadístico son similares a los que realizamos en nuestra vida cotidiana y que comprender los conceptos básicos del análisis estadístico no requiere conocimiento matemático alguno. En contra de lo que muchos investigadores creen, el valor de p del test no es un ‘índice matemático’ que nos permita concluir claramente si, por ejemplo, un fármaco es más efectivo que el placebo. El valor de p del test es simplemente un porcentaje.(AU)

Abstract. Leading scientific journals in fields such as medicine, biology and sociology repeatedly publish articles and editorials claiming that a large percentage of doctors do not understand the basics of statistical analysis, which increases the risk of errors in interpreting data, makes them more vulnerable to misinformation and reduces the effectiveness of research. This problem extends throughout their careers and is largely due to the poor training they receive in statistics – a problem that is common in developed countries. As stated by H. Halle and S. Krauss, ‘90% of German university lecturers who regularly use the p-value in tests do not understand what that value actually measures’. It is important to note that the basic reasoning of statistical analysis is similar to what we do in our daily lives and that understanding the basic concepts of statistical analysis does not require any knowledge of mathematics. Contrary to what many researchers believe, the p-value of the test is not a ‘mathematical index’ that allows us to clearly conclude whether, for example, a drug is more effective than a placebo. The p-value of the test is simply a percentage.(AU)

Experiences of patients with advanced cancer coping with chronic pain: a qualitative analysis.

OBJECTIVES: To gain insight into the perceptions, and beliefs of patients with advanced cancer coping with chronic pain and to identify their attitudes and demands on pain management. METHODS: From July to September 2022, 17 patients with advanced cancer living with chronic pain were recruited from a tertiary cancer hospital in Hunan Province, China. Qualitative and semi-structured interviews were conducted individually, with 30-45 minutes for each. The Colaizzi 7-step analysis method in phenomenological research was used for data analysis. RESULTS: The experience of pain acceptance by advanced cancer patients with chronic pain was summarized into four themes: pain catastrophizing (unable to ignore the pain, try various methods to relieve the pain, exaggerating pain perception, and lack of knowledge about proper pain management), rumination (compulsive rumination and worrying rumination), avoidance coping (situational avoidance and repressive avoidance) and constructive action (setting clear value goal and taking reciprocal action). CONCLUSION: Most patients with advanced cancer had low pain acceptance and negative attitudes. Feeling helpless in the face of pain and suffering alone were their norm. Long-term negative emotions could lead to gradual depression and loss of hope for treatment, resulting in pain catastrophizing and persistent rumination. Nevertheless, a few patients accepted pain with positive attitudes. Medical professionals should pay more attention to the psychological status of advanced cancer patients with chronic pain, and employ alternative therapies, for example, cognitive behavioral therapy. More efforts are needed to reduce patients' pain catastrophizing, and promote their pain acceptance by a better understanding of pain through health education.

Evidence-based interventions for identifying candidate quality indicators to assess quality of care in diabetic foot clinics: a scoping review.

BACKGROUND: Foot ulcers in people with diabetes are a serious complication requiring a complex management and have a high societal impact. Quality monitoring systems to optimize diabetic foot care exist, but a formal and more evidence-based approach to develop quality indicators (QIs) is lacking. We aimed to identify a set of candidate indicators for diabetic foot care by adopting an evidence-based methodology. METHODS: A systematic search was conducted across four academic databases: PubMed, Embase CINAHL and Cochrane Library. Studies that reported evidence-based interventions related to organization or delivery of diabetic foot care were searched. Data from the eligible studies were summarized and used to formulate process and structure indicators. The evidence for each candidate QI was described in a methodical and transparent manner. The review process was reported according to the "Preferred Reported Items for Systematic reviews and Meta-Analysis" (PRISMA) statements and its extension for scoping reviews. RESULTS: In total, 981 full-text articles were screened, and 322 clinical studies were used to formulate 42 candidate QIs. CONCLUSIONS: An evidence-based approach could be used to select candidate indicators for diabetic foot ulcer care, relating to the following domains: wound healing interventions, peripheral artery disease, offloading, secondary prevention, and interventions related to organization of care. In a further step, the feasibility of the identified set of indicators will be assessed by a multidisciplinary panel of diabetic foot care stakeholders.

"So at least now I know how to deal with things myself, what I can do if it gets really bad again"-experiences with a long-term cross-sectoral advocacy care and case management for severe multiple sclerosis: a qualitative study.

BACKGROUND: Persons with severe Multiple Sclerosis (PwsMS) face complex needs and daily limitations that make it challenging to receive optimal care. The implementation and coordination of health care, social services, and support in financial affairs can be particularly time consuming and burdensome for both PwsMS and caregivers. Care and case management (CCM) helps ensure optimal individual care as well as care at a higher-level. The goal of the current qualitative study was to determine the experiences of PwsMS, caregivers and health care specialists (HCSs) with the CCM. METHODS: In the current qualitative sub study, as part of a larger trial, in-depth semi-structured interviews with PwsMS, caregivers and HCSs who had been in contact with the CCM were conducted between 02/2022 and 01/2023. Data was transcribed, pseudonymized, tested for saturation and analyzed using structuring content analysis according to Kuckartz. Sociodemographic and interview characteristics were analyzed descriptively. RESULTS: Thirteen PwsMS, 12 caregivers and 10 HCSs completed interviews. Main categories of CCM functions were derived deductively: (1) gatekeeper function, (2) broker function, (3) advocacy function, (4) outlook on CCM in standard care. Subcategories were then derived inductively from the interview material. 852 segments were coded. Participants appreciated the CCM as a continuous and objective contact person, a person of trust (92 codes), a competent source of information and advice (on MS) (68 codes) and comprehensive cross-insurance support (128 codes), relieving and supporting PwsMS, their caregivers and HCSs (67 codes). CONCLUSIONS: Through the cross-sectoral continuous support in health-related, social, financial and everyday bureaucratic matters, the CCM provides comprehensive and overriding support and relief for PwsMS, caregivers and HCSs. This intervention bears the potential to be fine-tuned and applied to similar complex patient groups. TRIAL REGISTRATION: The study was approved by the Ethics Committee of the University of Cologne (#20-1436), registered at the German Register for Clinical Studies (DRKS00022771) and in accordance with the Declaration of Helsinki.

Implementation and evaluation of an interprofessional prescription writing workshop with a simulated electronic prescribing activity for preclerkship medical students.

BACKGROUND: Prescription writing skills are essential for physician practice. This study describes the development and implementation of a curricular intervention focused on improving the knowledge and confidence of preclerkship medical students' prescription writing practices utilizing an interprofessional education model, with a focus on electronic prescribing. METHODS: Medicine and Pharmacy Faculty from a large, urban university collaborated to develop the content of the workshop and a simulation platform was used for the e-prescribing activity. Second-year medical students attended a mandatory in-person workshop facilitated by fourth-year pharmacy students. A pre and post knowledge test and confidence survey were used to assess students' knowledge, confidence, and satisfaction. Outcomes from the knowledge test were evaluated with paired-samples proportions tests, and confidence survey data was evaluated with paired t-tests and Wilcoxon signed-rank tests in a pre-post study design. RESULTS: Students demonstrated a significant increase in prescription writing knowledge and confidence after completing the workshop. On the pre-test, 7% of students (21/284) completed the electronic prescribing assessment correctly and 51% of students (149/295) completed it correctly on the post-test. All items on the confidence survey showed a significant increase in pre- versus post-survey comparisons (p < 0.001). CONCLUSIONS: This interprofessional prescription writing workshop facilitated by pharmacy students shows promise for improving the knowledge and confidence of prescription writing and electronic prescribing practices in preclerkship medical students.

Perspectives on Injectable HIV Pre-Exposure Prophylaxis: A Qualitative Study of Health Care Providers in the United States.

The introduction of injectable HIV pre-exposure prophylaxis (PrEP) has the potential to significantly change the biomedical HIV prevention landscape. However, effective implementation will require health care providers to adopt, prescribe, and administer injectable PrEP within clinical settings. This study qualitatively examined challenges and benefit of injectable PrEP implementation from the perspective of health care providers. From April to August 2022, we conducted 19 in-depth interviews with current PrEP-prescribing health care providers in New York State, including 3 physician assistants, 5 physicians, and 11 nurse practitioners. Interviews were audio-recorded, transcribed verbatim, and thematically analyzed to report semantic-level themes regarding injectable PrEP implementation. More than half of participants (61%) were aware of injectable PrEP; only 21% had experience prescribing it. Qualitative findings highlighted five themes. Three themes represented implementation challenges, including speculative concerns about side effects, appointment compliance, and practical and logistical considerations. The remaining two themes described benefits of injectable PrEP relative to oral PrEP, which included greater convenience and enhanced privacy. Findings from this qualitative study make significant applied contributions to the sparse knowledge on health care provider perspectives of injectable PrEP post-US Food and Drug Administration approval and their concerns and considerations regarding implementation in real-world clinical settings.

Digital Health Technology (DHT) in European Clinical Trials, How to Improve the Status-Quo of the Regulatory Landscape?

Digital health technology (DHT) is increasingly used to facilitate the conduct of clinical drug trials. The European regulatory environment would benefit from some adjustments to realize the full potential of DHTs. Considering current discussions such as the European Accelerating Clinical Trial Initiative (ACT EU), we propose four concrete adjustments to this regulatory landscape to introduce risk-based qualification approaches for DHTs. In our view, these changes would have the potential to facilitate the use of DHT in clinical research and thus provide access to innovative therapies in Europe.

An optimization framework for large-scale screening under limited testing capacity with application to COVID-19.

We consider the problem of targeted mass screening of heterogeneous populations under limited testing capacity. Mass screening is an essential tool that arises in various settings, e.g., ensuring a safe supply of blood, reducing prevalence of sexually transmitted diseases, and mitigating the spread of infectious disease outbreaks. The goal of mass screening is to classify whole population groups as positive or negative for an infectious disease as efficiently and accurately as possible. Under limited testing capacity, it is not possible to screen the entire population and hence administrators must reserve testing and target those among the population that are most in need or most susceptible. This paper addresses this decision problem by taking advantage of accessible population-level risk information to identify the optimal set of sub-populations to target for screening. We conduct a comprehensive analysis that considers the two most commonly adopted schemes: Individual testing and Dorfman group testing. For both schemes, we formulate an optimization model that aims to minimize the number of misclassifications under a testing capacity constraint. By analyzing the formulations, we establish key structural properties which we use to construct efficient and accurate solution techniques. We conduct a case study on COVID-19 in the United States using geographic-based data. Our results reveal that the considered proactive targeted schemes outperform commonly adopted practices by substantially reducing misclassifications. Our case study provides important managerial insights with regards to optimal allocation of tests, testing designs, and protocols that dictate the optimality of schemes. Such insights can inform policy-makers with tailored and implementable data-driven recommendations.

Adolescent Cancer Survivors and Their Parents' Experiences With the Transition Off Treatment to Survivorship: A Qualitative Interview Study.

Background: Transitioning from active cancer treatment to survivorship represents a vulnerable yet underresearched phase for adolescents and their families. Knowledge of their support needs, the challenges they experience, and how they manage them are useful to inform tailored follow-up care. Thus, we aimed to explore their transition experiences. Method: We interviewed 15 adolescents (12-19 years) who had transitioned off of treatment 1 to 47 months prior at Oslo University Hospital's Department of Paediatric Haematology and Oncology and their biological parents (n = 16). The interviews were analyzed using inductive, reflexive thematic analysis inspired by Braun and Clarke. NVivo-12 was used for data management. Results: Four main themes were identified: (a) consequences of cancer beyond transition, (b) transition back to normalcy, (c) survivorship competence, and (d) changes in roles and relationships. The families described happiness and relief but also said that the lingering effects of cancer treatment had a profound impact on day-to-day living. The adolescents expressed closeness with and dependency on their parents, and they perceived family and friends as essential for social readjustment. Discussion: Although adolescent survivors and their parents described a wide variety of strategies for returning to "normalcy," their perspectives also illustrate ongoing psychosocial and educational support needs that changed over time. Our findings indicate a need for improved preparation for and support through the transition. Nurses are well positioned to provide continuous and structured transition support tailored to the needs of the individual survivors and their families.

Exploring the Pathways of Diabetes Foot Complications Treatment and Investigating Experiences From Frontline Health Care Professionals: Protocol for a Mixed Methods Study.

BACKGROUND: Diabetes affects more than 4.3 million individuals in the United Kingdom, with 19% to 34% developing diabetes-related foot ulceration (DFU) during their lifespan, which can lead to an amputation. In the United Kingdom, every week, approximately 169 people have an amputation due to diabetes. Preventing first-ever ulcers is the most effective strategy to reduce the occurrence of diabetes-related amputations, but research in this space is lacking. OBJECTIVE: This protocol seeks to document the experiences and perspectives of frontline health care professionals who work with people who have diabetes and diabetes-related foot problems. Special attention is given to their perceptions of barriers to effective care, their views about barriers to effective and inclusive engagement with people with diabetes, and their experience with the first-ever DFU. Another aspect of the study is the focus on whether clinical management is affected by data sharing, data availability, and interoperability issues. METHODS: This is a mixed methods explanatory protocol, which is sequential, and its purpose is to use the qualitative data to explain the initial quantitative data collected through a survey of frontline health care professionals. Data analysis of quantitative data will be completed first and then synthesized with the qualitative data analysis. Qualitative data will be analyzed using the framework method. This study will use joint displays to integrate the data. Ethical approval has been granted by the ethics committee of Staffordshire University. RESULTS: The quantitative data collection started in March 2023 and will close in May 2024. The qualitative interviews commenced in November 2023 with volunteer participants who initially completed the survey. CONCLUSIONS: This study's survey focuses on data interoperability and the interviews focus more on the perspectives and experiences of clinicians and their perceived barriers for the effective management of diabetes foot ulcers. Including a geographically relevant and diverse cohort of health care professionals that spans a wide range of roles and care settings involved in diabetes-related foot care is very important for the successful application of this protocol. Special care is given to advertise and promote participation as widely as possible. The qualitative part of this protocol is also limited to 30-40 interview participants, as it is not realistic to interview higher numbers, due to time and resource constraints. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/54852.

Co-Design, Development, and Evaluation of a Mobile Solution to Improve Medication Adherence in Cancer: Design Science Research Approach.

BACKGROUND: Medication nonadherence negatively impacts the health outcomes of people with cancer as well as health care costs. Digital technologies present opportunities to address this health issue. However, there is limited evidence on how to develop digital interventions that meet the needs of people with cancer, are perceived as useful, and are potentially effective in improving medication adherence. OBJECTIVE: The objective of this study was to co-design, develop, and preliminarily evaluate an innovative mobile health solution called Safety and Adherence to Medication and Self-Care Advice in Oncology (SAMSON) to improve medication adherence among people with cancer. METHODS: Using the 4 cycles and 6 processes of design science research methodology, we co-designed and developed a medication adherence solution for people with cancer. First, we conducted a literature review on medication adherence in cancer and a systematic review of current interventions to address this issue. Behavioral science research was used to conceptualize the design features of SAMSON. Second, we conducted 2 design phases: prototype design and final feature design. Last, we conducted a mixed methods study on patients with hematological cancer over 6 weeks to evaluate the mobile solution. RESULTS: The developed mobile solution, consisting of a mobile app, a web portal, and a cloud-based database, includes 5 modules: medication reminder and acknowledgment, symptom assessment and management, reinforcement, patient profile, and reporting. The quantitative study (n=30) showed that SAMSON was easy to use (21/27, 78%). The app was engaging (18/27, 67%), informative, increased user interactions, and well organized (19/27, 70%). Most of the participants (21/27, 78%) commented that SAMSON's activities could help to improve their adherence to cancer treatments, and more than half of them (17/27, 63%) would recommend the app to their peers. The qualitative study (n=25) revealed that SAMSON was perceived as helpful in terms of reminding, supporting, and informing patients. Possible barriers to using SAMSON include the app glitches and users' technical inexperience. Further needs to refine the solution were also identified. Technical improvements and design enhancements will be incorporated into the subsequent iteration. CONCLUSIONS: This study demonstrates the successful application of behavioral science research and design science research methodology to design and develop a mobile solution for patients with cancer to be more adherent. The study also highlights the importance of applying rigorous methodologies in developing effective and patient-centered digital intervention solutions.

The PICOTS-ComTeC Framework for Defining Digital Health Interventions: An ISPOR Special Interest Group Report.

OBJECTIVES: Digital health definitions are abundant, but often lack clarity and precision. We aimed to develop a minimum information framework to define patient-facing digital health interventions (DHIs) for outcomes research. METHODS: Definitions of digital-health-related terms (DHTs) were systematically reviewed, followed by a content analysis using frameworks, including PICOTS (population, intervention, comparator, outcome, timing, and setting), Shannon-Weaver Model of Communication, Agency for Healthcare Research and Quality Measures, and the World Health Organization's Classification of Digital Health Interventions. Subsequently, we conducted an online Delphi study to establish a minimum information framework, which was pilot tested by 5 experts using hypothetical examples. RESULTS: After screening 2610 records and 545 full-text articles, we identified 101 unique definitions of 67 secondary DHTs in 76 articles, resulting in 95 different patterns of concepts among the definitions. World Health Organization system (84.5%), message (75.7%), intervention (58.3%), and technology (52.4%) were the most frequently covered concepts. For the Delphi survey, we invited 47 members of the ISPOR Digital Health Special Interest Group, 18 of whom became the Delphi panel. The first, second, and third survey rounds were completed by 18, 11, and 10 respondents, respectively. After consolidating results, the PICOTS-ComTeC acronym emerged, involving 9 domains (population, intervention, comparator, outcome, timing, setting, communication, technology, and context) and 32 optional subcategories. CONCLUSIONS: Patient-facing DHIs can be specified using PICOTS-ComTeC that facilitates identification of appropriate interventions and comparators for a given decision. PICOTS-ComTeC is a flexible and versatile tool, intended to assist authors in designing and reporting primary studies and evidence syntheses, yielding actionable results for clinicians and other decision makers.

A framework for leveraging network course-based undergraduate research experience (CURE) faculty to develop, validate, and administer an assessment instrument.

Over the last several years, nationally disseminated course-based undergraduate research experiences (CUREs) have emerged as an alternative to developing a novel CURE from scratch, but objective assessment of these multi-institution (network) CUREs across institutions is challenging due to differences in student populations, instructors, and fidelity of implementation. The time, money, and skills required to develop and validate a CURE-specific assessment instrument can be prohibitive. Here, we describe a co-design process for assessing a network CURE [the Prevalence of Antibiotic Resistance in the Environment (PARE)] that did not require support through external funding, was a relatively low time commitment for participating instructors, and resulted in a validated instrument that is usable across diverse PARE network institution types and implementation styles. Data collection efforts have involved over two dozen unique institutions, 42 course offerings, and over 1,300 pre-/post-matched assessment record data points. We demonstrated significant student learning gains but with small effect size in both content and science process skills after participation in the two laboratory sessions associated with the core PARE module. These results show promise for the efficacy of short-duration CUREs, an educational research area ripe for further investigation, and may support efforts to lower barriers for instructor adoption by leveraging a CURE network for developing and validating assessment tools.

A case study to engage students in the research design and ethics of high-throughput metagenomics.

Case studies present students with an opportunity to learn and apply course content through problem solving and critical thinking. Supported by the High-throughput Discovery Science & Inquiry-based Case Studies for Today's Students (HITS) Research Coordination Network, our interdisciplinary team designed, implemented, and assessed two case study modules entitled "You Are What You Eat." Collectively, the case study modules present students with an opportunity to engage in experimental research design and the ethical considerations regarding microbiome research and society. In this manuscript, we provide instructors with tools for adopting or adapting the research design and/or the ethics modules. To date, the case has been implemented using two modalities (remote and in-person) in three courses (Microbiology, Physiology, and Neuroscience), engaging over 200 undergraduate students. Our assessment data demonstrate gains in content knowledge and students' perception of learning following case study implementation. Furthermore, when reflecting on our experiences and student feedback, we identified ways in which the case study could be modified for different settings. In this way, we hope that the "You Are What You Eat" case study modules can be implemented widely by instructors to promote problem solving and critical thinking in the traditional classroom or laboratory setting when discussing next-generation sequencing and/or metagenomics research.

Glossary of healthcare pathways: a methodological approach involving a transdisciplinary team in public health.

Introduction: The healthcare pathway is at the heart of public health organization concerns, but communication between the various players can be an obstacle. This work, produced by a French transdisciplinary team, offers a methodological approach based on formalized consensus to elaborate a glossary of healthcare pathways. A two-steps procedure was elaborated, including a double rounded Delphi method to formalize expert consensus, and two groups of experts: a workgroup and a review group. Methods: The workgroup provided a list of words or expressions that, in their opinion, described, evaluated or compared the healthcare pathways for patients, caregivers or regulators. The review group checked this list and added or deleted words or expressions. Then, definitions were added by the workgroup based into account three dimensions: official, academic and from the field. The review group validated the definitions and provided complementary proposals if needed. Results: After pooling the list of words proposed by each of the six members of the working group, 417 words/expressions were ranked. After the two rounds of evaluation, 294 words/expressions were rated "appropriate" and were analyzed by the review group. This group, after two rounds of evaluation, agreed on 263 words/expressions that were transmitted to the working group who defined them. These definitions were rated by the review group. The first round of evaluation established 195 definitions as being appropriated whereas 68 definitions were amended by the review group. Conclusion: This glossary supports transdisciplinary communication, reduces the extent of variations in practice and optimizes decision-making. International debate on all aspects might be strengthened by an improved understanding of the concept of health pathway.

Single mothers by choice - experiences of single women seeking treatment at a public fertility clinic in Denmark: A pilot study.

PROBLEM: There has been an increase in the number of single women deciding to have children through the use of medically assisted reproduction (MAR). These women are referred to as 'single mothers by choice' (SMC). BACKGROUND: Previous studies have shown how SMC can feel stigmatised. AIM: Explore if single women seeking fertility treatment in Denmark feel stigmatised. METHODS: Six single women undergoing MAR at a public fertility clinic in Denmark were interviewed. The interviews were audiotaped, anonymised, and transcribed in full, after provided written consent by the participants to take part in the study. Data were analysed using qualitative content analysis. FINDINGS: The women would have preferred to have a child in a relationship with a partner. Despite their dream of the nuclear family meaning a family group consisting of two parents and their children (one or more), the women choose to become SMC because motherhood was of such importance, and they feared they would otherwise become too old to have children. The participants did not experience stigma or negative responses to their decision, but they all had an awareness of the prejudices other people might have towards SMC. CONCLUSION: This study contributes to the understanding of the experiences of single women seeking fertility treatment in a welfare state where there are no differences in the possibilities for different social classes to seek MAR.

The impact of incorporating a simulation program into the undergraduate nursing curricula: A cross-sectional descriptive study.

AIM: To determine the degree of satisfaction for each academic year and according to the type of simulation performed (simulated patient actor/advanced simulator) among nursing students after the use of clinical simulation. INTRODUCTION: Clinical simulation is currently being incorporated in a cross-cutting manner throughout undergraduate nursing education. Its implementation requires a novel curricular design and educational changes throughout the academic subjects. DESIGN: A cross-sectional descriptive study was performed. METHODS: During the academic years 2018-2019 and 2019-2020, 425 students completed the High-Fidelity Simulation Satisfaction Reduced Scale for Students based on 25 questions and six factors, with a total score between 0 and 125. In total, 91 simulation sessions were performed among students who had different degrees of clinical and previous experience with simulation as well as standardized patient versus advanced simulator. A bivariate analysis was performed, comparing the total scores and the different subscales by sex, previous experience, academic year, and simulation methodology. Linear regression was used for both bivariate and multivariate analysis. RESULTS: The mean scale score was 116.8 (SD=7.44). The factor with the highest score was "F2: feedback or subsequent reflection", with a mean score of 14.71 (SD=0.73) out of 15. Fourth year students scored the highest (mean=119.17; SD=5.28). Students who underwent simulation training with a simulated patient actor presented a higher level of overall satisfaction (p<0.05) (Mean=120.31; SD=4.91), compared to students who used an advanced simulator (Mean=118.11; SD=5.75). CONCLUSIONS: Satisfaction with the simulation program was higher in fourth-year students compared to first-year students and was also higher when a simulated patient actor was used compared to an advanced simulator. The most highly valued aspect was the subsequent debriefing or reflective process.

Closed-loop automated drug infusion regulator: A clinically translatable, closed-loop drug delivery system for personalized drug dosing.

BACKGROUND: Dosing of chemotherapies is often calculated according to the weight and/or height of the patient or equations derived from these, such as body surface area (BSA). Such calculations fail to capture intra- and interindividual pharmacokinetic variation, which can lead to order of magnitude variations in systemic chemotherapy levels and thus under- or overdosing of patients. METHODS: We designed and developed a closed-loop drug delivery system that can dynamically adjust its infusion rate to the patient to reach and maintain the drug's target concentration, regardless of a patient's pharmacokinetics (PK). FINDINGS: We demonstrate that closed-loop automated drug infusion regulator (CLAUDIA) can control the concentration of 5-fluorouracil (5-FU) in rabbits according to a range of concentration-time profiles (which could be useful in chronomodulated chemotherapy) and over a range of PK conditions that mimic the PK variability observed clinically. In one set of experiments, BSA-based dosing resulted in a concentration 7 times above the target range, while CLAUDIA keeps the concentration of 5-FU in or near the targeted range. Further, we demonstrate that CLAUDIA is cost effective compared to BSA-based dosing. CONCLUSIONS: We anticipate that CLAUDIA could be rapidly translated to the clinic to enable physicians to control the plasma concentration of chemotherapy in their patients. FUNDING: This work was supported by MIT's Karl van Tassel (1925) Career Development Professorship and Department of Mechanical Engineering and the Bridge Project, a partnership between the Koch Institute for Integrative Cancer Research at MIT and the Dana-Farber/Harvard Cancer Center.