Question #1; two consequences to subject safety if sites are unable to track down subjects to ensure adequate follow-up: When planning a study, patient engagement and potential attrition should be strongly considered when writing the protocol. Subject visit schedules, planned procedures and length of the trial can have an impact on whether a patient is willing to finish the trial without early discontinuation. In any study, issues may arise such as Adverse Events which may cause a patient to need to exit the trial, however in some cases subjects may decide returning for additional visits or follow up is not worth their time and prematurely exit. Should a considerable percentage of subjects fail to return for visits or follow up, there is significant potential trial results could be skewed (Dettori, 2011). If skewed trial results show positive safety and efficacy, a drug could be brought to market and prescribed to millions of people erroneously. There is a chance this drug could not be as effective as current standard of care leading to a decline in patient health. There could also be missed safety signals that could possibly have been seen/discovered in the trial if all visits or follow-up for all subjects had been completed, thus risking subject safety. Question #2; two methods of ensuring subject retention and explanation: There are many methods sites and sponsors have implemented to ensure subject follow up visits and interviews. From a study published in 1996, a group in St. Louis, MO details a 96.6% follow up rate for a notoriously difficult study population and suggests that detailed contact information be collected at the very start so there are multiple ways to contact an enrolled subject (Cottler et al., 1996). This information should be reviewed and updated at every visit (or at least verified the information is still valid). The authors stress persistence, creativity and flexibility on behalf of the study team in continuing to find and follow up with subjects, which depending upon the culture at a study site may pose a problem if the site staff is unwilling to put in the needed efforts. Another consideration for study retention is use of incentives or subject payments as subjects move through trial activities. Subject payment and incentives must be carefully considered in an ethical frame to ensure that these would not be considered as coercion or bribery. Payments and incentives need to be practical and fair to all potential subjects so that time and travel are adequately compensated and potentially help to remove any barriers to participation. REFERENCES: Cottler, L. B., Compton, W. M., Ben-Abdallah, A., Horne, M., & Claverie, D. (1996). Achieving a 96.6 percent follow-up rate in a longitudinal study of drug abusers. Drug and Alcohol Dependence, 41(3), 209–217. https://doi.org/10.1016/0376-8716(96)01254-9 Dettori J. R. (2011). Loss to follow-up. Evidence-based spine-care journal, 2(1), 7–10. https://doi.org/10.1055/s-0030-1267080 Kimberly Question 1: If the site is unable to track down enrolled subjects, the site can risk not knowing if study medication has caused an adverse event. Having follow ups with subjects is not only for their safety, but others participating in the trials as well. If there have been other side effects noted by other participants in the study or an adverse event has been reported that causes the study to stop, the site needs to inform all the subjects. If they are unable to track down a subject, they could be at an increased risk for developing a reported side effect or adverse event. Another consequence if a site is unable to track down a subject, they may run out of study medication. The study medication for the study could be helping them and their disease/condition. If you as a site coordinator/PI are unable to track them down, if they have run out of medication, their condition/disease may not be under control. This could cause a worsening in their condition requiring more medication, some that may not be OK to take. The subject may also not have any of their prior medication (if any) that they were using to help keep their disease/condition under control before starting the study. Question 2: There are many reasons that subjects may feel the need to dropout or discontinue the study early. Its our job to help ensure that we keep subject retention high. One common way that studies do this is by providing compensation to the subjects. Subjects can sometimes feel the financial burden of having to take time off from jobs, school, etc. and use gas money to come to the study visits (Morrison). Providing some type of compensation for their time and commitment could help with retaining them throughout the study. One problem with this, is that sometimes the compensation does not cover the needed expenses for the person participating and therefore they choose not to participate. Another reason subjects may dropout is due to the uncertainty of the trial (2004). To ensure subject retention in this scenario, the PI, study coordinator, or anyone else in the trial can continually reach out to the subject to ensure they dont have any questions unanswered. Site staff can explain the procedures at each visit and ensure that the patient feels comfortable and reassure them that the product is safe and effective from prior studies. Site staff can provide their phone number, email, etc. so that the participant has a way to contact them with any questions or concerns. Open communication throughout the study is important and will go a long way in subject retention. A problem with this method may be that the subject still decides to dropout due to the fear of the unknown.
Mastering the Art of Online Learning: Your Guide to Acing Online Courses
Introduction
In recent years, the popularity of online courses has skyrocketed, offering learners the flexibility to acquire new skills and knowledge from the comfort of their homes. However, succeeding in online courses requires a different approach compared to traditional classroom settings. To help you make the most of your online learning experience, this article presents essential strategies and tips to ace your online courses.
1. Set Clear Goals and Plan Ahead
Before embarking on an online course, establish clear goals and objectives. Determine what you hope to achieve by the end of the course and break down your goals into manageable milestones. Create a study schedule that aligns with your other commitments, ensuring you allocate dedicated time for coursework, assignments, and revision.
2. Create a Productive Study Environment
Establishing a conducive study environment is crucial for online learning success. Find a quiet, well-lit space where you can concentrate without distractions. Remove any potential interruptions, such as notifications from social media or email. Organize your study materials and have a reliable internet connection to ensure seamless access to course materials.
3. Actively Engage in the Course
Active participation is key to mastering online courses. Engage with course materials, including videos, readings, and interactive components. Take comprehensive notes, highlighting key concepts and ideas. Participate in discussion boards, forums, and virtual meetings to interact with instructors and peers, fostering a sense of community and enhancing your understanding of the subject matter.
4. Manage Your Time Effectively
Online courses offer flexibility, but it’s essential to manage your time wisely to avoid falling behind. Create a detailed schedule, allocating specific time slots for coursework, assignments, and studying. Break down larger tasks into smaller, manageable segments to prevent procrastination. Prioritize tasks based on deadlines and dedicate focused time to each one, ensuring consistent progress throughout the course.
5. Develop Effective Communication Skills
Online courses often rely on written communication, making it crucial to hone your skills in this area. Be concise and clear in your written responses, paying attention to grammar and spelling. Actively participate in discussions, asking thoughtful questions and providing constructive feedback to your peers. Regularly check your course emails and notifications, ensuring you stay updated with any important announcements or changes.
6. Utilize Available Resources
Take full advantage of the resources provided by your online course platform and instructors. Familiarize yourself with the learning management system (LMS) and explore its features. Access supplementary materials, such as textbooks, lecture slides, and external resources recommended by instructors. Utilize online libraries, research databases, and tutorial services to deepen your understanding of the subject matter.
7. Stay Motivated and Engaged
Maintaining motivation throughout an online course can be challenging, particularly when faced with competing priorities or a lack of face-to-face interaction. Set short-term goals and reward yourself upon their completion. Connect with fellow learners through virtual study groups or online forums to foster a sense of camaraderie. Regularly remind yourself of the benefits and personal growth associated with completing the course successfully.
8. Seek Support and Clarification
Don’t hesitate to seek support or clarification when needed. Reach out to your instructors for guidance or clarification on course material. Utilize online discussion forums to ask questions or engage in collaborative problem-solving. Leverage the support services provided by your course platform or institution, such as technical support or academic advising.
Conclusion
Online courses present unique opportunities for self-paced learning and personal growth. By setting clear goals, creating a productive study environment, actively engaging with course materials, and managing your time effectively, you can maximize your chances of acing online courses. Remember to stay motivated, seek support when needed, and make the most of the available resources. Embrace the flexibility and adaptability of online learning to achieve your educational goals.
Recent Comments