This document discusses patient diaries which are used in clinical trials to record patients' experiences and health status over time. It defines what patient diaries are, who writes in them, and different types including paper-based diaries, electronic diaries using handheld devices, PDAs, mini computers, and IVR systems. The benefits of electronic diaries over paper diaries are outlined, such as improved data quality and compliance. Guidelines are provided on when diaries can be started and how they support clinical research objectives.
The document defines key terms related to clinical trial monitoring such as monitoring, monitoring visits, and monitoring reports. It describes the purpose of monitoring is to protect subjects, ensure accurate data, and ensure compliance. It discusses selecting qualified monitors and different types of monitoring visits including site evaluation, initiation, routine monitoring, and close-out visits. The key responsibilities of monitors during visits are also summarized.
This document defines a source document as an original document where clinical trial data is first recorded, such as medical records, laboratory notes, or subjects' diaries. Source documents can be either electronic or paper. Electronic source documents must meet requirements regarding computer system validation, electronic records, electronic signatures, and technical support. Paper source documents are typically handwritten forms or records with the investigator's original signature. The document discusses challenges of source document verification like informed consent processes and adverse event reporting. It provides examples of informed consent procedures for patients who cannot read, are disabled, or lack decision-making capacity.
The document discusses case report forms (CRFs), which are used in clinical trials to record patient data. It defines CRFs and explains that they contain all protocol-required information including adverse events. The goals of CRFs are to collect verifiable data according to Good Clinical Practice standards. CRFs can be paper-based or electronic. Well-designed CRFs are structured and formatted consistently to facilitate accurate data collection while avoiding duplication. CRFs provide essential standardized data that is analyzed to advance medical research.
Investigator Site File (ISF) / Trial Master file in trial (TMF)KiranRajput38
This document discusses the investigator site file (ISF) for a Phase 3 clinical trial of COVAXINE, a COVID-19 vaccine. It notes that the principal investigator is responsible for creating and maintaining the ISF. The contents of the ISF include essential documents like the protocol, informed consent forms, and case report forms. The document outlines procedures for maintaining the ISF, including updating it ongoing, filing documents without delay, and replacing outdated versions of documents. It also discusses who is responsible for single site studies and maintaining organization and version control of important documents in the ISF.
A clinical research coordinator (CRC) is responsible for conducting clinical trials according to regulatory requirements and under the supervision of the principal investigator. The CRC acts as a vital link between all parties involved in the clinical trial. Their responsibilities include completing feasibility assessments, obtaining ethics committee approval, recruiting and retaining subjects, maintaining documentation, ensuring safety of patients, and closing out the trial in accordance with regulations.
This document discusses adverse events and serious adverse events in clinical trials. It defines key terms like adverse event, adverse drug reaction, serious adverse event, and unexpected adverse event. It describes the importance of collecting and reporting adverse events in clinical trials from regulatory and ethical perspectives to protect human subjects. It provides examples and criteria for assessing severity, causality, expectedness, and timeframes for reporting serious and unexpected adverse events to regulatory agencies, institutional review boards, and other investigators. It also addresses managing reporting for blinded trials and reactions associated with active comparators.
The sponsor is responsible for initiating, managing, and financing clinical trials. This includes selecting investigators and sites, defining responsibilities, submitting documents for regulatory approval, monitoring safety and progress, ensuring proper labeling and storage of investigational products, auditing sites for compliance, and preparing and submitting clinical trial reports to regulatory authorities. The sponsor may delegate trial-related duties to third parties like CROs but retains ultimate responsibility for the trial.
Introduction to Aggregate Reporting in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
The document defines key terms related to clinical trial monitoring such as monitoring, monitoring visits, and monitoring reports. It describes the purpose of monitoring is to protect subjects, ensure accurate data, and ensure compliance. It discusses selecting qualified monitors and different types of monitoring visits including site evaluation, initiation, routine monitoring, and close-out visits. The key responsibilities of monitors during visits are also summarized.
This document defines a source document as an original document where clinical trial data is first recorded, such as medical records, laboratory notes, or subjects' diaries. Source documents can be either electronic or paper. Electronic source documents must meet requirements regarding computer system validation, electronic records, electronic signatures, and technical support. Paper source documents are typically handwritten forms or records with the investigator's original signature. The document discusses challenges of source document verification like informed consent processes and adverse event reporting. It provides examples of informed consent procedures for patients who cannot read, are disabled, or lack decision-making capacity.
The document discusses case report forms (CRFs), which are used in clinical trials to record patient data. It defines CRFs and explains that they contain all protocol-required information including adverse events. The goals of CRFs are to collect verifiable data according to Good Clinical Practice standards. CRFs can be paper-based or electronic. Well-designed CRFs are structured and formatted consistently to facilitate accurate data collection while avoiding duplication. CRFs provide essential standardized data that is analyzed to advance medical research.
Investigator Site File (ISF) / Trial Master file in trial (TMF)KiranRajput38
This document discusses the investigator site file (ISF) for a Phase 3 clinical trial of COVAXINE, a COVID-19 vaccine. It notes that the principal investigator is responsible for creating and maintaining the ISF. The contents of the ISF include essential documents like the protocol, informed consent forms, and case report forms. The document outlines procedures for maintaining the ISF, including updating it ongoing, filing documents without delay, and replacing outdated versions of documents. It also discusses who is responsible for single site studies and maintaining organization and version control of important documents in the ISF.
A clinical research coordinator (CRC) is responsible for conducting clinical trials according to regulatory requirements and under the supervision of the principal investigator. The CRC acts as a vital link between all parties involved in the clinical trial. Their responsibilities include completing feasibility assessments, obtaining ethics committee approval, recruiting and retaining subjects, maintaining documentation, ensuring safety of patients, and closing out the trial in accordance with regulations.
This document discusses adverse events and serious adverse events in clinical trials. It defines key terms like adverse event, adverse drug reaction, serious adverse event, and unexpected adverse event. It describes the importance of collecting and reporting adverse events in clinical trials from regulatory and ethical perspectives to protect human subjects. It provides examples and criteria for assessing severity, causality, expectedness, and timeframes for reporting serious and unexpected adverse events to regulatory agencies, institutional review boards, and other investigators. It also addresses managing reporting for blinded trials and reactions associated with active comparators.
The sponsor is responsible for initiating, managing, and financing clinical trials. This includes selecting investigators and sites, defining responsibilities, submitting documents for regulatory approval, monitoring safety and progress, ensuring proper labeling and storage of investigational products, auditing sites for compliance, and preparing and submitting clinical trial reports to regulatory authorities. The sponsor may delegate trial-related duties to third parties like CROs but retains ultimate responsibility for the trial.
Introduction to Aggregate Reporting in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
This document discusses quality assurance and quality control in clinical research. It defines quality assurance as planned actions to ensure a trial complies with good clinical practice and regulations. Quality control refers to operational techniques that verify quality requirements are fulfilled. Ensuring accurate, reliable data is an ongoing challenge managed through monitoring data collection and management at all study levels. Sponsors are responsible for quality systems with standard operating procedures and allowing monitoring, auditing and inspections. Quality assurance and quality control help ensure successful project completion and credible, compliant research.
Clinical trials that are needed for efficacy & safety evidence of Medical devices include feasibility (pilot) and Pivotal trials. An extended battery of preclinical trials are also needed for high risk devices.
Case Processing Work Flow in PharmacoviglanceClinosolIndia
The case processing workflow in pharmacovigilance involves a series of steps and activities to manage and analyze individual cases of adverse drug reactions (ADRs) and other drug-related problems. While specific processes may vary depending on the pharmacovigilance system and organization, here is a generalized overview of the case processing workflow
Essential Documents of Clinical Trials_2heba rashed
Essential documents for clinical trials include documents that demonstrate compliance with good clinical practice standards and regulations. These documents are grouped into three sections: before, during, and after the clinical trial. Key documents include the protocol, patient consent forms, safety reports, data records, and archival documents that must be retained for 15 years. Maintaining organized essential document files is important for evaluating trial conduct and data quality.
This document defines an investigational product and outlines requirements for its use in clinical trials. An investigational product refers to a drug, biologic, device, or other therapy being studied for safety and efficacy. Key points covered include that investigational products must be manufactured and handled according to Good Manufacturing Practice standards and used per the approved trial protocol. Labeling, storage, and distribution of investigational products are also discussed.
The document provides an overview of discrepancy management in clinical data management. It defines discrepancies as inconsistencies in clinical trial data that need correction. It discusses the goal of discrepancy management as accurately representing captured study data. It also describes different types of discrepancies like system-generated, electronically-generated, and manual discrepancies. Additionally, it outlines the discrepancy management process which involves identifying discrepancies, resolving them by updating data or sending queries to investigators, and updating the clinical database.
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
The document discusses medical writing, which involves producing scientific documentation for researchers who are not directly involved in the studies. It describes the need for medical writing due to the complex nature of clinical trials and regulations. There are two main types of medical writing - regulatory, which creates documents for approval processes, and educational, which makes information accessible to healthcare professionals and the public. Medical writers require skills like attention to detail, writing ability, and scientific knowledge. Their duties can include drafting protocols, reports, and manuscripts for publication.
This document outlines safety reporting procedures for a clinical trial, including definitions of adverse events and serious adverse events, causality assessment guidelines, reporting timelines, and medical management of adverse events. Adverse events will be monitored for 28 days following vaccination and reported within required timelines. Serious adverse events must be reported within 24 hours of occurrence and followed up until resolution. The ethics committee, regulatory authorities, and sponsor will assess causality and determine compensation if needed.
A sponsor in literal terms is defined as an individual or a company or an institution that takes the responsibility for the initiation, management and/or financing of a clinical study.
In case an investigator independently initiates and takes full responsibility for a trial, he/she automatically assumes the role of a sponsor.
Lets, just get to know more about safety reporting in clinical trails with some terminologies, reporting requirements of ADR, compensations involved and finally the role of ethics committee in it,
Clinical trial protocol, ammendments, Protocol deviations and violationsAmol Patil
This document provides guidelines for developing a clinical trial protocol including general information, background, aims and objectives, inclusion/exclusion criteria, study design, methodology, statistics, ethics, quality control, and protocol amendments. Key elements that must be addressed in the protocol are enumerated such as the research question, treatment characteristics, data collection and analysis, and legal responsibilities. Protocol deviations and violations that occur during the study are also discussed along with examples and regulatory requirements for reporting them. Adherence to good clinical practice and obtaining necessary approvals are emphasized.
This document outlines the roles and responsibilities of ethics committee (EC) members in reviewing clinical trial protocols. It describes the composition of ECs, which includes chairs, clinicians, scientists, legal experts, social scientists, philosophers, theologians, and lay people. The roles of EC members include scientifically and ethically reviewing protocols, informed consent documents, risks and benefits, qualifications, and providing ongoing trial oversight. The chair oversees meetings while the member secretary organizes documentation and communication. Together the multidisciplinary EC works to protect research participants.
This document provides an overview of pharmacovigilance systems and regulations in the US and EU. It describes regulatory oversight bodies, key regulations governing pharmacovigilance, safety reporting requirements during pre-marketing and post-marketing periods, pediatric legislation differences, and risk management strategies between the regions.
This document outlines procedures for reporting and managing serious adverse events (SAEs) related to research. It defines an SAE as an untoward medical occurrence that may not be causally related to the research. Investigators are responsible for reporting SAEs using a study-specific form within a specified timeframe. The chief investigator then reviews the SAE for seriousness, causality, and expectedness. For related or unexpected SAEs, the trial manager submits reports to the approving research ethics committee. The trial management group may provide consensus on SAE classifications as needed. The document provides detailed guidance on procedures for classifying, documenting, reporting and following up on SAEs.
This document discusses audits and inspections in clinical trials. It defines an audit as a systematic examination of trial activities and documents to determine compliance, while an inspection involves a regulatory review of documents, facilities, and resources related to a trial. The key differences between audits and inspections are that audits are conducted internally by sponsors or CROs, while inspections are done by regulatory authorities. Routine audits ensure compliance, while for-cause audits investigate non-compliance issues. Audits and inspections evaluate areas like personnel, trial conduct, documentation, drug accountability, and computer systems. Proper preparation and responding to document requests within time limits are important for audits and inspections.
The CRA oversees all stages of clinical trials from site selection to completion. They identify investigators, set up trial sites, train staff, monitor compliance, and verify informed consent and data collection. The CRA ensures protocols are followed, documents are collected, and supplies are accounted for throughout the trial. Effective communication, relationship building, attention to detail, and strong organizational skills are important for this role.
The document describes Prescription Event Monitoring (PEM), a method of pharmacovigilance that involves collecting information on patient outcomes after being prescribed new medications. PEM was developed in the 1980s in the UK to address limitations of spontaneous adverse event reporting. It involves sending questionnaires to prescribers to obtain follow-up data on patients. Analysis of the data provides incidence rates of adverse events and allows detection of potential safety issues with new drugs. Modified PEM (M-PEM) expands the method to collect additional targeted safety information.
TSDP tells about the essential documents that are required for the #conduct of a clinical trial. For #regulatory medical writing training, contact hello@turacoz.in.
Patient safety has always been the industry’s focus during clinical trials. However, a recent spate of well-publicized patient safety issues have increased public scrutiny and the biotechnology, pharmaceutical and CRO industries' desire to improve study quality, resulting in larger, longer, more expensive trials. In this Q&A, James T. Gourzis, M.D., Ph.D., discusses issues affecting patient safety, including factors that have launched safety to the forefront; what to look for in evaluating CRO excellence; unique oncology considerations and the ramifications of the rare toxicity; optimizing the Data Monitoring Committee; budget decisions that affect patient safety and the evolution/future of FDA requirements.
Diaries are a research tool that require respondents to regularly record their daily activities and experiences. They can be open-format or highly structured, depending on the level of detail required. Diary studies typically last long enough to capture behaviors or events of interest. Different types of diaries include paper-based, email-based, text-based, voice-based, and social media-based. Diaries are useful for collecting sensitive information and as a supplement to interviews, as respondents can record entries in their own time and a wide range of people can participate without training. However, diaries also have limitations such as incomplete entries, lack of cooperation from some, and difficulty verifying accuracy.
This document discusses quality assurance and quality control in clinical research. It defines quality assurance as planned actions to ensure a trial complies with good clinical practice and regulations. Quality control refers to operational techniques that verify quality requirements are fulfilled. Ensuring accurate, reliable data is an ongoing challenge managed through monitoring data collection and management at all study levels. Sponsors are responsible for quality systems with standard operating procedures and allowing monitoring, auditing and inspections. Quality assurance and quality control help ensure successful project completion and credible, compliant research.
Clinical trials that are needed for efficacy & safety evidence of Medical devices include feasibility (pilot) and Pivotal trials. An extended battery of preclinical trials are also needed for high risk devices.
Case Processing Work Flow in PharmacoviglanceClinosolIndia
The case processing workflow in pharmacovigilance involves a series of steps and activities to manage and analyze individual cases of adverse drug reactions (ADRs) and other drug-related problems. While specific processes may vary depending on the pharmacovigilance system and organization, here is a generalized overview of the case processing workflow
Essential Documents of Clinical Trials_2heba rashed
Essential documents for clinical trials include documents that demonstrate compliance with good clinical practice standards and regulations. These documents are grouped into three sections: before, during, and after the clinical trial. Key documents include the protocol, patient consent forms, safety reports, data records, and archival documents that must be retained for 15 years. Maintaining organized essential document files is important for evaluating trial conduct and data quality.
This document defines an investigational product and outlines requirements for its use in clinical trials. An investigational product refers to a drug, biologic, device, or other therapy being studied for safety and efficacy. Key points covered include that investigational products must be manufactured and handled according to Good Manufacturing Practice standards and used per the approved trial protocol. Labeling, storage, and distribution of investigational products are also discussed.
The document provides an overview of discrepancy management in clinical data management. It defines discrepancies as inconsistencies in clinical trial data that need correction. It discusses the goal of discrepancy management as accurately representing captured study data. It also describes different types of discrepancies like system-generated, electronically-generated, and manual discrepancies. Additionally, it outlines the discrepancy management process which involves identifying discrepancies, resolving them by updating data or sending queries to investigators, and updating the clinical database.
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
The document discusses medical writing, which involves producing scientific documentation for researchers who are not directly involved in the studies. It describes the need for medical writing due to the complex nature of clinical trials and regulations. There are two main types of medical writing - regulatory, which creates documents for approval processes, and educational, which makes information accessible to healthcare professionals and the public. Medical writers require skills like attention to detail, writing ability, and scientific knowledge. Their duties can include drafting protocols, reports, and manuscripts for publication.
This document outlines safety reporting procedures for a clinical trial, including definitions of adverse events and serious adverse events, causality assessment guidelines, reporting timelines, and medical management of adverse events. Adverse events will be monitored for 28 days following vaccination and reported within required timelines. Serious adverse events must be reported within 24 hours of occurrence and followed up until resolution. The ethics committee, regulatory authorities, and sponsor will assess causality and determine compensation if needed.
A sponsor in literal terms is defined as an individual or a company or an institution that takes the responsibility for the initiation, management and/or financing of a clinical study.
In case an investigator independently initiates and takes full responsibility for a trial, he/she automatically assumes the role of a sponsor.
Lets, just get to know more about safety reporting in clinical trails with some terminologies, reporting requirements of ADR, compensations involved and finally the role of ethics committee in it,
Clinical trial protocol, ammendments, Protocol deviations and violationsAmol Patil
This document provides guidelines for developing a clinical trial protocol including general information, background, aims and objectives, inclusion/exclusion criteria, study design, methodology, statistics, ethics, quality control, and protocol amendments. Key elements that must be addressed in the protocol are enumerated such as the research question, treatment characteristics, data collection and analysis, and legal responsibilities. Protocol deviations and violations that occur during the study are also discussed along with examples and regulatory requirements for reporting them. Adherence to good clinical practice and obtaining necessary approvals are emphasized.
This document outlines the roles and responsibilities of ethics committee (EC) members in reviewing clinical trial protocols. It describes the composition of ECs, which includes chairs, clinicians, scientists, legal experts, social scientists, philosophers, theologians, and lay people. The roles of EC members include scientifically and ethically reviewing protocols, informed consent documents, risks and benefits, qualifications, and providing ongoing trial oversight. The chair oversees meetings while the member secretary organizes documentation and communication. Together the multidisciplinary EC works to protect research participants.
This document provides an overview of pharmacovigilance systems and regulations in the US and EU. It describes regulatory oversight bodies, key regulations governing pharmacovigilance, safety reporting requirements during pre-marketing and post-marketing periods, pediatric legislation differences, and risk management strategies between the regions.
This document outlines procedures for reporting and managing serious adverse events (SAEs) related to research. It defines an SAE as an untoward medical occurrence that may not be causally related to the research. Investigators are responsible for reporting SAEs using a study-specific form within a specified timeframe. The chief investigator then reviews the SAE for seriousness, causality, and expectedness. For related or unexpected SAEs, the trial manager submits reports to the approving research ethics committee. The trial management group may provide consensus on SAE classifications as needed. The document provides detailed guidance on procedures for classifying, documenting, reporting and following up on SAEs.
This document discusses audits and inspections in clinical trials. It defines an audit as a systematic examination of trial activities and documents to determine compliance, while an inspection involves a regulatory review of documents, facilities, and resources related to a trial. The key differences between audits and inspections are that audits are conducted internally by sponsors or CROs, while inspections are done by regulatory authorities. Routine audits ensure compliance, while for-cause audits investigate non-compliance issues. Audits and inspections evaluate areas like personnel, trial conduct, documentation, drug accountability, and computer systems. Proper preparation and responding to document requests within time limits are important for audits and inspections.
The CRA oversees all stages of clinical trials from site selection to completion. They identify investigators, set up trial sites, train staff, monitor compliance, and verify informed consent and data collection. The CRA ensures protocols are followed, documents are collected, and supplies are accounted for throughout the trial. Effective communication, relationship building, attention to detail, and strong organizational skills are important for this role.
The document describes Prescription Event Monitoring (PEM), a method of pharmacovigilance that involves collecting information on patient outcomes after being prescribed new medications. PEM was developed in the 1980s in the UK to address limitations of spontaneous adverse event reporting. It involves sending questionnaires to prescribers to obtain follow-up data on patients. Analysis of the data provides incidence rates of adverse events and allows detection of potential safety issues with new drugs. Modified PEM (M-PEM) expands the method to collect additional targeted safety information.
TSDP tells about the essential documents that are required for the #conduct of a clinical trial. For #regulatory medical writing training, contact hello@turacoz.in.
Patient safety has always been the industry’s focus during clinical trials. However, a recent spate of well-publicized patient safety issues have increased public scrutiny and the biotechnology, pharmaceutical and CRO industries' desire to improve study quality, resulting in larger, longer, more expensive trials. In this Q&A, James T. Gourzis, M.D., Ph.D., discusses issues affecting patient safety, including factors that have launched safety to the forefront; what to look for in evaluating CRO excellence; unique oncology considerations and the ramifications of the rare toxicity; optimizing the Data Monitoring Committee; budget decisions that affect patient safety and the evolution/future of FDA requirements.
Diaries are a research tool that require respondents to regularly record their daily activities and experiences. They can be open-format or highly structured, depending on the level of detail required. Diary studies typically last long enough to capture behaviors or events of interest. Different types of diaries include paper-based, email-based, text-based, voice-based, and social media-based. Diaries are useful for collecting sensitive information and as a supplement to interviews, as respondents can record entries in their own time and a wide range of people can participate without training. However, diaries also have limitations such as incomplete entries, lack of cooperation from some, and difficulty verifying accuracy.
The document provides guidelines for the structure and content of clinical study reports. It outlines 16 sections that should be included in a study report, such as the title page, synopsis, investigational plan, study patients, efficacy and safety evaluations, discussion and conclusions. The guidelines aim to produce a complete, unambiguous and well-organized report to facilitate regulatory review.
This document discusses various physics concepts and clinical measurements related to anaesthesia. It covers gas laws, critical temperatures, solubility, diffusion, osmosis, electricity, fluid dynamics, and blood pressure monitoring. Key points include definitions of Boyle's law, Charles' law, and Dalton's law of partial pressures. It also discusses non-invasive and invasive blood pressure monitoring techniques.
Clinical assessment involves gathering information to understand abnormal behavior and determine how to help an individual. It can follow three models: the info-gathering model focuses on collecting relevant data; the therapeutic model aims to evaluate treatment progress; and the differential treatment model seeks to determine the best treatment approach. Common assessment methods include clinical interviews, intelligence and personality tests, and behavioral observations. Projective tests like the Rorschach inkblot technique and TAT are also used to reveal unconscious thoughts and feelings.
This document discusses pain assessment. It defines pain and notes that pain assessment includes subjective and objective components. The subjective assessment involves taking a pain history, including onset, duration, location, and intensity measured using scales like numeric, verbal, or visual analogue scales. Objective assessment examines behavioral and physiological indicators of pain. Key aspects to assess include provocation, quality, referral or radiation of pain. Nursing interventions for pain include using assessment scales, administering analgesics, documenting pain severity, and teaching non-pharmacological pain management techniques.
Everything you need to know about diaries and journals: travel diaries, aka road diaries or travelogues, food or diet diaries, workout or exercise journals, audio, personal writing, creative writing, memory, prayer, and sleep diaries.
Text version: http://www.mac-diary.com/2010/03/types-of-diaries.html
This document provides information on pain management for internal medicine housestaff. It begins with definitions of pain from the International Association for the Study of Pain. It then covers the basic approach to pain management, including assessing the etiology, classifying pain types, clinically assessing pain, and treating pain. It discusses treating cancer pain specifically and provides guidelines on the WHO analgesic ladder for treating mild, moderate, and severe pain. It also covers adjuvant analgesics, opioid selection, routes of administration, and equianalgesic dosing of common opioids like morphine, oxycodone, fentanyl, hydromorphone, and methadone.
This document discusses pain and its treatment. It begins by defining pain and classifying common types of pain conditions. It then discusses the body's reflex responses to pain and the endorphin system that modulates pain. It describes the differences between acute and chronic pain and methods of pain measurement. Various treatment options are provided for different types of pain, including NSAIDs, opioids, tramadol, tapentadol, muscle relaxants, and sodium channel blockers. Newer treatments discussed include epirisone and the comparative properties of different NSAIDs, muscle relaxants, tramadol, and tapentadol. Key questions are also provided about comparing treatment effectiveness and safety across patient subgroups.
This document provides an overview of pain, including definitions, classifications, physiology, assessment, and management. It defines pain as an unpleasant sensory and emotional experience associated with actual or potential tissue damage. Pain is classified based on location, duration (acute vs chronic), and intensity (mild, moderate, severe). The physiology of pain involves transduction, transmission, modulation, and perception of pain signals in the nervous system. Nurses assess pain using scales and treat it using pharmacological and non-pharmacological methods based on the type and severity of the pain.
Culture is the driver of sustainable performance. Management board culture is not as elusive as often thought. It can be made concrete by evaluating management board performance, not only based on figures and strategic memos, but also on key cultural characteristics. It is time to rethink the role of non-executives in the boardroom.
This document provides guidance on effective scientific writing. It discusses why scientists should write, including to communicate their work, convey knowledge, and facilitate understanding. The document outlines aspects to consider when writing such as the writing process, elements of high-quality writing, and the style of writing. It emphasizes the importance of clarity, precision, structure, coherence, and using an active voice to objectively present information for the reader.
This presentation was delivered by the INDPETH Network (Nana Oye) to a workshop at the Liverpool School of Tropical Medicine on improving the use of research in policy and practice.
Skyals is a blog website is an online platform that serves as a regularly post written content in the form of articles, essays or posts. These entries, often arranged in reverse chronological order, cover a wide range of topics and are typically personalized with the blogger's unique perspective, expertise, or experiences, variety of purposes, including personal expression, sharing knowledge, building a professional online presence, promoting products or services, or engaging with a community of like-minded individuals. They have become a popular and accessible way for individuals and organizations to communicate and connect with a global audience on the internet.
The Nintendo Wii Presentation For Canada Professionals 2Ben Herz
This document discusses using the Nintendo Wii gaming system as an occupational therapy treatment for patients with Parkinson's disease. It summarizes evidence that physical activity, especially playing video games, can increase motor function and decrease Parkinson's symptoms. The study aims to determine if using the Wii can improve functional activities and motor skills for patients with Parkinson's in both the short-term and long-term following treatment. It hypothesizes that the Wii will increase patients' ability to perform daily tasks and functional movement, as well as decrease impairment, through interactive gaming sessions.
This document summarizes evidence from 27 trials involving over 10,000 participants on the safety and efficacy of clot-dissolving drugs (thrombolytics) such as alteplase for treating acute ischemic stroke. The trials compared thrombolytics administered intravenously or intra-arterially within 4.5 hours of stroke onset to placebo or no treatment. Thrombolytics were found to improve outcomes after stroke but also increase the risk of serious bleeding in the brain. While thrombolytics can restore blood flow and reduce brain damage if given promptly, the risks and benefits were shown to depend on the time since stroke onset.
- Veolia Transportation Washington Facility project involves renovating an existing 5-acre site into office and maintenance spaces, including propane fueling, buswash, and CNG fueling facilities.
- AFEX Corporate Office project involves renovating an existing 24,000sf building to consolidate AFEX headquarters, including renovations, new server room, and computer system migration.
- Haronian Medical Building project involves new construction of a 30,000sf, three-story medical office building with surgery centers and site work.
Research and Development in Roof-Top Solar Potentiality Using LiDAR Technology
Mr. Radhey Shyam Meena
M.Tech Scholar (Power System)
Student Member -The Institute of Engineering & Technology (IET), UACEE
Dept. Of Electrical Engineering
Sri Balaji College Of Engineering & Technology Jaipur Rajasthan Technical University Kota
4th International conference on “Advance Trend in Engineering, Technology and Research (ICATETR-2015)”
Date: 19-20 June-2015
Venue: Bal Krishna Institute of Technology, Kota IPC-15, RIICO Institutional Area, Ranpur Kota (Rajasthan) (India)
This document provides guidelines for writing effective laboratory reports. It outlines the key sections that should be included such as an introduction, methodology, analysis/results, and conclusion. Proper formatting is important, with the report title including course number, experiment title, student names, teaching assistant, and date. The abstract should be a concise summary without details, while the introduction discusses the experiment's purpose and objectives. Proper spelling, grammar, and technical writing skills are essential for clear communication.
WTIA Marketing Series: What Can You Learn from a Gaming Companynpyron
This document discusses concepts related to developing and understanding one's identity, including understanding oneself, learning from mistakes, measuring and improving performance over time, and gaining wisdom from life experiences. Key areas explored are goals, mistakes as learning opportunities, self-awareness, and personal growth.
This document summarizes the objectives and approach of the Continuous Update Project (CUP) Mechanisms Project. The project aims to develop guidelines for systematically reviewing mechanistic studies linking exposures like diet and cancer. It will create a template protocol through expert workshops and test it on a specific exposure-outcome link. Challenges include developing generalizable methods, assessing study quality, and determining relevance to humans. The methodology could mainstream how mechanistic evidence is reviewed and inform future research directions.
Legalism was an influential philosophical school in ancient China during the Spring and Autumn and Warring States periods. It emphasized ruling through strict laws and punishments rather than ethics or morality. Legalism viewed people as inherently self-interested and focused on strengthening state power through rule by law. It believed an authoritarian government could maintain social control and order. While effective in uniting early imperial China, Legalism is now seen as lacking concern for people's welfare. Confucianism later became the dominant philosophy.
This multi-disciplinary think tank at the University of Utah College of Architecture + Planning aims to improve the patient experience. It brings together students and faculty to explore healthcare delivery through design thinking and focus on complex problems. The group seeks to enhance quality and access through research on spaces, processes, and technologies that support patients and providers.
The document outlines an awareness campaign to grow golf participation in England. It identifies three key consumer groups - working males, retired couples, and settling down males aged 26-35. It highlights three regions of the country - South East, North West, and North East England - as targets for the campaign. The campaign aims to reach a wider audience and get more people playing golf regularly through regional outreach and tailored messaging to different consumer segments.
The document discusses setting up a Farmers Market organization and provides recommendations for its practices. It suggests the organization focus on supporting local farmers and producers by selling only locally-grown or made products. Guidelines are also provided around community engagement, vendor requirements, and operating procedures to help the market serve the community.
This document provides information on four top British schools located in Sharjah, United Arab Emirates. It summarizes the key details of each school, including their curriculum, facilities, values and contact information. The four schools discussed are:
1. Providence English Private School, which follows the British educational plan and aims to provide students with knowledge for future success.
2. International School of Creative Sciences, which provides both British and UAE curriculums and focuses on developing creative and critical thinking.
3. Scholars International Academy, which is accredited by top British organizations and offers a rigorous international British education program.
4. Sharjah English School, an established nonprofit school providing excellent quality British education along
Healthcare Improvement Scotland aims to continuously improve healthcare quality and safety in Scotland. It runs national improvement programs focused on areas like patient safety, healthcare associated infections, and person-centered care. Through measurement and data collection, the Scottish Patient Safety Program has demonstrated significant reductions in infection rates, improved compliance with best practices, and decreased mortality and length of stay in critical care units. The goal is to spread effective improvement strategies nationwide to benefit all Scottish patients.
Here are a few key points from the passage:
- Learning is difficult if the lesson/video game is not well planned. Learners don't realize how challenging it is.
- Good instructors help guide students along their learning journey so the information has meaning and purpose. They provide context and support.
- Overtly telling students information is less effective than engaging them in active learning through well-designed lessons and games. When students are having fun, they don't realize how much they are actually learning.
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The document discusses a study on diabetes mellitus-induced atrial fibrillation. It identifies the MAPK10 gene as a critical regulator using time-series RNA sequencing analysis of mice. Various methods are used like real-time PCR, western blot analysis, and tunnel assay to analyze cardiac tissues and identify proteins. Results show MAPK10, TNFα, and tubulin expression increasing over time in db/db mice. The discussion cites previous studies finding hyperglycemia contributes to atrial fibrosis and remodeling, increasing atrial fibrillation susceptibility. Graphics are important for immunological studies and molecular biology advances medical research.
Similar to Patient Diary by Abhinandan Sandhu (20)
1. Patient Diaries
Abhina a Sa hu
nd n nd
Fa ulty a C
c t linic l Re e rc Ins
a s a h titute
a hi_g
b ill@ ya o o
ho .c .in
2. Objective
W t a P tie d irie ?
ha re a nt a s
W ta P
ha re ROs ?
Ne dfo p tie d rie
e r a nt ia s
W w sin thed ry?
ho rite ia
Typ so d rie
e f ia s
C m a o o p p r a e c nicd rie
o p ris n f a e nd le tro ia s
C a n o d rie
re tio f ia s
Sub c p fe nc s
je t re re e
3. What are Patient Dairy?
Patient Diary is a to l us d d
o e uring a
clinic l tria o a d e s tre tm nt to
a l r is a e a e
m a uretre tm nt c m lia e
es a e o p nc
P tie s Dia a o p vid s w a
a nt’ ry ls ro e ith
s le ha y p c to d c e he lth
ing , nd la e o um nt a
ins nc p lic info a n, d c r’
ura e o y rm tio o to s
vis , p s rip ns a q s ns fo
its re c tio , nd ue tio r
yo ur d c rs
o to , p rm c t a
ha a is nd
ins nc c m a
ura e o p ny
4. What are PROs
P tie
a nt-re o d o o e (P
p rte utc m s RO)
ha lo b e e s ntia s urc s o
ve ng e n s e l o e f
d ta
a in b p rm c utic l
io ha a e a
c ma sc
o p nie ' linic l re e rc
a sa h
A PRO is a m a ure e o a
e s m nt f ny
a p c o a p tie s he lth s tus
s et f a nt’ a ta
tha c m s d c fro thep tie
t o e ire tly m a nt
(i.e w ut the inte re tio o
., itho rp ta n f
the p tie s re p ns s b a
a nt’ so e y
p ic n o a nee e
hys ia r nyo ls )
5. Emergence of Psychometrics
P rha s the m s im o nt d ve p e ha b e
e p o t p rta e lo m nt s e n
g a r a ntio to p yc m tric , the s ie e o
re te tte n s ho e s c nc f
a s s ingp tie e e nc
ses a nt xp rie e
Qua tive w rk is inc a ing to e ure tha the
lita o re s ly ns t
inte e m a ure ta s the full ra e o p tie
nd d e s p ng f a nt
e e nc s a q s nna s a s je te to
xp rie e nd ue tio ire re ub c d
rig ro q ntita s tis a te ts
o us ua tive ta tic l s
6. Need of Diaries in Clinical Trials
So etreatment effects a known only to the patient
m re
To know the patient perspective a o the e c ne s
b ut ffe tive s
o atre tm nt
f a e
Sys m tic a s s m nt o the patient’s perspective may
te a ses e f
provide valuable information tha c n b lo t w n tha
t a e s he t
p rs e tive is filte d thro h a c
e pc re ug linic n’ e lua n o
ia s va tio f
thep tie sre p ns toc
a nt’ s o e linic l inte wq s ns
a rvie ue tio
7. PROs Objectives
Thefo us o P
c f RO m a ure is s
e s s hifting fro b a
m ro d
q lity o life a s s m nts to measures of signs
ua f ses e
and symptoms, w h m y b d e s s e ific
hic a e is a e p c
Tre tm nt-re te changes in quality of life
a e la d
Direct consequences of disease and treatment,
the ha m reo n s rve a p a e p ints
y ve o fte e d s rim ry nd o
in clinic l tria
a ls
8. When can the Diary be started
In clinic l tria , d iry iss re p r tous o
a ls a ta d rio e f
inve tig tio l a e
s a na g nt
In inte ivec re d rie a us lly s rte o the
ns a , ia s re ua ta d n
p tie sthirdd y b c us p tie w s y
a nt’ a e a e a nts ho ta
lo e us lly e e nc m rem m ry g p
ng r ua xp rie e o e o as
9. Who writes in the Diary ?
P tie him e re o stheo s rva ns
a nt s lf c rd b e tio
A d ry ke t b nurs s w n in the
ia p y e , ritte
IC d
U uring p rio s o c a illne s
e d f ritic l s,
w h isha e o r to thep tie w n
hic nd d ve a nts he
the a c ns e d a le to re e it in
y re o id re b c ive
c s o inte ivec re
ae f ns a
In c s o c re e r the p re o
a e f hild n, ithe a nts r
c re und r thes e io o p re
hild n e up rvis n f a nts
10. Types of Patient Diaries
Paper Based
Electronic Handheld device diaries
Personal data assistants (PDAs)
Mini computers
IVR systems
11. Paper Diary
P tie
a nts ke p a d ily p p r d ry
e a ae ia
thro ho
ug ut the s y a
tud nd re o
c rd
s p m w n the e e nc dthe
ym to s he y xp rie e m
P p r p tie d rie c nno b tra ke fo
a e a nt ia s a t e c d r
a he nc tothere o
d re e p rtings he ule
c d
If thep tie fo e to c m le thed ry
a nt rg ts o p te ia
o the d te the s p m o c d the
n a ym to c urre , y
c n c m le the d ry la r, inc a ing
a o p te ia te re s
thelike o tha d taw h ise re is
liho d t a hic nte d
ina c te
c ura
12. Paper Diaries
The d ta re o
a p rting s ture
truc
s und p p r d rie is s w a
urro ing a e ia s lo nd
cs
o tly
By the tim the a e tio
e b rra ns are
d c ve d the p tie c n no lo e
is o re , a nt a ng r
re e b r the c rre t re p ns a
mm e o c s o e nd
im o nt d ta is lo t w h c n
p rta a s hic a
im a t theo o eo thes y
pc utc m f tud
13. Paper Diaries
The a ila ility o re va d ta
va b f le nt a
o re uire tim is q
n q d e uite
c m lic te a d ult
o p a d nd iffic
Re e rc r
s a he ha s to s a h
e rc
m nua
a lly fo re o
r p rts in the
e us
xha tive file a b the tim
s nd y e
he find the s e ific d ry he
s pc ia
m y s the p int he w nts to
a kip o a
put
14. PROs go Electronic
Clinic l re e rc rs ha
a s a he ve us d p p r
e ae
d rie fo tha p o e s e the 19 0 ,
ia s r t urp s inc 4s
b in a a m t to o rc m s je t
ut n tte p ve o e ub c
no o p nc a d ta ua p b m
nc m lia e nd a -q lity ro le s
a s c te w p p r d rie , the no
s o ia d ith a e ia s y w
o n us EDs
fte e
Re e s ie ha s w tha p tie
c nt tud s s ho n t a nt
c m lia e in va us c
o p nc rio linic l tria
a ls
inc a e totrip w theus o e ia s
re s s le ith e f -d rie
15. Rationale for Developing EDs
The a p a n o EDs ha its ro ts in the e
p lic tio f s o s
p rs te p b m a s c te w
e is nt ro le s s o ia d ith p p r
ae
d rie
ia s
P o d taq lity
o r a ua
Lo d la to d talo k
ng e ys a c
P o s je t c m lia e
o r ub c o p nc
Theris p te l fo lo s d m g
ks o ntia r s , a a e
Ina c c
c ura y
16. Electronic based Patient Diaries
Ele tro
c nic d ry m tho s fo c lle ting d ta fro
ia e d r o c a m
p tie in c
a nts linic l tria w sd ve p d in 19 7
a ls a e lo e 8
An Electronic Patient Diary re is rs thed ry in a
g te ia
s ra ed vic a a w fo m nito
to g e e nd llo s r o ringthetim the
e
m d a n w s ta n, a s p m o Qua o
e ic tio a ke nd ym to s r lity f
Lifed tare o e
a c rd d
Sp ns rs s uld e ta lis a ‘ o
o o ho s b h to lkit’o p fe d
f re rre
te hno g a a a o
c lo y nd n lg rithm b w h the c n
y hic y a
d c e w h te hno g to a p to a p rtic r
e id hic c lo y p ly a ula
s y
tud
17. Handheld Device diaries
De e c n b c nfig d to b e o fla h to re ind the
vic s a e o ure le p r s m
p tie o as he ule d ry e
a nt f c d d ia ntry
The in-built s re n fa ilita s the e
c e c te ntry o fre te a
f e xt nd
vis l a lo ue s a d ta a c n a o b us d to p s nt
ua na g c le a , nd a ls e e re e
o c e d
n-s re n uringd ry c m le n
ia o p tio
The m in lim tio c ntre a und the e s o us , the
ir a ita ns e ro ir a e f e
re uire e to d p y a
q m nt e lo nd m inta ha w re a
a in rd a , nd
c nne tivity is ue
o c s
18.
19. Personal Data Assistants (PDAs)
The e d vic s ha
s e e ve a s a s re n to d p y
m ll c e is la
q s ns a
ue tio , nd a num e o b ns to c ntro
b r f utto o l
na a n thro h q s ns a to a s n a re p ns
vig tio ug ue tio nd s ig so e
toaq s n
ue tio
Da c lle te o the P
ta o c d n DA is tra m d b the
ns itte y
s je t,
ub c thro h
ug w le s
ire s o r a lo
na g
te c m unic tio , to a c ntra s rve ho te b the
le o m a ns e l e r s d y
e RO s lutio p vid r
P o n ro e
The PDAs c n b p g m e to he p tie
a e ro ra m d lp a nts
re e b r tore o the d ta
mm e c rd ir a
20. IVR systems
IVR s te s a a c s e b the p tie w
ys m re c e s d y a nt ho
te p ne into a c ntra c m ute s te via a to
le ho s e l o p r ys m ll-
fre num e
e br
P -re o e m s a e c m ris the d ry q s ns
re c rd d e s g s o p e ia ue tio ,
a re p ns s a m d us
nd s o e re a e ing the ke o the
ys f
te p neke a
le ho yp d
21. IVR systems
IVRS re o s the info a n in vo e fo a a
c rd rm tio ic rm t nd
tha c nve it intofilefo a
n o rt rm t
Da a e re d c
ta re nte d ire tly onto the c ntra IVR
e l
d ta a e e ina
a b s , lim ting d w a a
o nlo d nd c nne tivity
o c
is ue a m king a d ry d ta a ila le fo re w
s s nd a ll ia a va b r vie
in re l-tim
a e
IVR d rie us the te p ne ke a to e r d ta
ia s e le ho yp d nte a ,
m king it id a fo c lle tio o num ric b ry,
a el r o c n f e , ina
o ina s a , a c te o a ultip -c ic
rd l c le nd a g ric l/m le ho e
22. IVR Systems
Ea h p tie e
c a nt ntry is tim s m e w the p tie s
e ta p d ith a nt’
lo a tim d c e
cl e o um ntinge c w n thec ll ism d
xa tly he a ae
The IVR s te d fine a w o o tim d
ys m e s ind w f e uring
w h the p tie re o s p m tha the a
hic a nt p rts ym to s t y re
e e nc
xp rie ing a the m m nt o w
t o e r ithin the p vio
re us
12 4ho
-2 urs
Re o
p rting p ra e rs a s t d p nd w re o the
a m te re e e e ing he n
g b thep tie re id s
lo e a nt s e
23. IVR Systems
P g m e to g ne tea a rt w n d taise re
ro ra m d e ra n le he a nte d
w h isinva o o id a c p dra e
hic lid r uts e c e te ng s
Re p nd nts a im e ia ly p m te to re nte
so e re m d te ro p d -e r
d ta
a
Thus c nflic a re o dre o ly a ins ntly
, o ts re s lve m te nd ta
24. IVR Patie nt Diary
Patient diary call
Daily / weekly symptoms data
Update eCRFs
Record
diary IVR Non-compliance EDC
data alerts
System System
Query
cycle
Update IVR Patient enrolment
database - Screening number
- Initials
- Date of birth
- IVR user-envelope number
Withdrawal event
Adapted from Presentation EDC-IVR Integration, David M. Fishbach
25. Adapted from Electronic Diary Solutions: Enhanced Collection of Patient Reported Outcomes Data by
Dr Bill Byrom
26. Use of Electronic Diary
Ele tro p tie d rie he m ke s lf-re o d
c nic a nt ia s lp a e p rte
p tie d tam h m rere b fo c m a s
a nt a uc o lia le r o p nie
e RO re o c n b s nt to thes y te min re l
P p rts a e e tud a a
tim ,e
Elim te theris o lo s sin tra it
ina s k f se ns
P vid ss s ntia m red c tio a p c
ro e ub ta lly o is re n nd riva y
fo thep tie
r a nt
27. Limitations of Paper Based Diary
The c m o is ue ra e w n c lle ting d ta fro
o m n s s is d he o c a m
p p r-b s d ins
a e ae trum ntsa tha o le ib
e re t f g ility a hum n
nd a
e r w n inte re
rro he rp tingha w n a w rs
nd ritte ns e
All m nne o a c e
a r f c id nts c n ha p n, le d
a pe a ing to the
p p r b ingd m g d o e n lo t b fo e ingup b c
ae e a a e r ve s e re nd ak
in theha so thes y m na e e te m
nd f tud a g m nt a
Fa ric tio o thed ta
b a n f a
28. Limitations of Paper Based Diary
Sp llingc n a oa c thea c c o thed ta a this
e a ls ffe t c ura y f a , s
c n le dthete mtom keap s ib s rio
a a a a o s ly e us
m inte re tio
is rp ta n
W thea m tra
ith d inis tiveb e o typ upthe
urd n f ing
ha w n re p ns s
nd ritte s o e
29. Benefits of e-Patient Diary
Re l-tim , 2 /7 a c s
a e 4 c es
P m te p tie c m lia e
ro o s a nt o p nc
P vid sp c s c ns te y
ro e ro e s o is nc
Dra a a re uc shum n e r
m tic lly d e a rro
Im ro sd tare b
p ve a lia ility
Sa stim a m ne
ve e nd o y
He re e rc rs m re e c ly m na e p tie
lp s a he o ffe tive a g a nts
in s ie w re s lf-re o d d ta a a ke
tud s he e p rte a re y
e p int
nd o
30. Adapted from Applied Clinical Trials, Jun 1, 2004: Proving the eDiary Dividend by Sara McKenzie
31. FDA's ALCOA
The FDA's ALCOA (Attributable, Legible,
Contemporaneous, Original, Accurate) criteria
for patient data in labelling claims have helped
to substantiate the argument for using ePRO, as
patient data is far more accurate when collected
electronically
32. Compliance by Paper and Electronic
Subject Diary
Adapted from Applied Clinical Trials, Jun 1, 2004: Proving the eDiary Dividend by Sara McKenzie
33. Compliance by paper and electronic subject
diary
Adapted from Applied Clinical Trials, Jun 1, 2004: Proving the eDiary Dividend by Sara McKenzie
34. Aim of the Patient diary
Atte p to m a ureb th thee c ne s a
mt es o ffe tive s nd
thes ee c o tre tm nt
id ffe ts f a e
Me s
a ure the a ve e c ns q nc s o
d rs o e ue e f
tre tm nt s p ra ly fro the e c ne s o
a e e a te m ffe tive s f
tre tm nt
a e
35. Creation of the Diaries
W n d ve p
he e lo ing a d ry, s o o a e o g d to
ia p ns rs re nc ura e
a s s its a e ua y in the c nte o the fo w
ses dq c o xt f llo ing
d ve p e p c s e
e lo m nt ro e s s
Ge ra n o Ite s
ne tio f m
C ic o theDa C lle tio Me d
ho e f ta o c n tho
C ic o theRe a P rio
ho e f c ll e d
C ic o Re p ns Op ns
ho e f s o e tio
36. Creation of the Diaries
Eva tio o P tie Und rs nd
lua n f a nt e ta ing
De lo m nt
ve p e of Fo a
rm t, Ins tio ,
truc ns and
Training
C nfirm tio o the C nc p l Fra e o a
o a n f o e tua m w rk nd
Fina tio o theDAIRY
liza n f
37. Prior to e Diaries
Training s je ts is a ke
ub c y
e m nt in a e RO s lutio
le e ny P o n
Inve tig to ne d to b a le to
s a rs e e b
he s je ts us the e rie
lp ub c e Dia s
thro ho thes y
ug ut tud
38. A symbol based Patient Diary for children
Most children between 5
and 8 years old have not
yet learned to write full
sentences
Electronic patient diary in
which small children at
age 5-8 could express their
feelings through symbols
and drawings
39. Subjects Preference
The e p a lite ture re c a c a s je t p fe nc
m iric l ra fle ts le r ub c re re e
fo e c nicd rie re tivetop p r d rie
r le tro ia s la a e ia s
Drum o a c lle g s re o d tha 5
m nd nd o a ue p rte t 7% o the
f ir
s je ts w g s inte tina d o e p fe d the
ub c ith a tro s l is rd rs re rre
e c nic a s s m nt, a o 13 p fe d thep p r
le tro s e s e nd nly % re rre ae
ve io ; 3 % e re s dnop fe nc
rs ns 0 xp s e re re e
40. Subjects Preference
Tip d a c lle g s c m a d EDs a p p r d rie in 2
la y nd o a ue o p re nd a e ia s 2
re p to c
s ira ry linic o a nts w s lf-m nito d w
utp tie ho e o re ith b th
o
m tho s fo fo w e ; 5 % e re s d p fe nc fo the ED
e d r ur e ks 9 xp s e re re e r
o r thep p r d ry, 18 p fe d p p r, a 2 % e re s d no
ve a e ia % re rre a e nd 3 xp s e
p fe nc
re re e
Fina J ha s a c lle g s fo
lly, o nne nd o a ue und tha a p xim te 70
t p ro a ly %
o the a m le s m le (n=2 ) p fe d a ED ve us a p p r
f ir ll-fe a a p 3 re rre n rs ae
m ns l d ry
e trua ia