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Patient Diary
A patient diary is a tool used during a clinical trial or a disease treatment to assess the patient's condition (e.g. symptom severity, quality of life) or to measure treatment compliance. An electronic patient diary registers the data in a storage device and allows for automatically monitoring the time the entry was made. Frequent recording of symptoms using a diary helps to reduce recall bias. Electronic diaries ensure entries are made as scheduled, and not, for example, in a batch immediately before the clinic visit. Patient diaries are also way to find out if a patient takes the medication according to the treatment schedule, which is an important problem during clinical trials and the treatment of degenerative diseases with relatively few symptoms. See also * Case report form * Electronic patient reported outcomes (ePRO) * Patient-reported outcome A patient-reported outcome (PRO) is a health outcome directly reported by the patient who experienced it. It stands in contrast ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Case Report Form
A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient. All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events. The sponsor of the clinical trial develops the CRF to collect the specific data they need in order to test their hypotheses or answer their research questions. The size of a CRF can range from a handwritten one-time 'snapshot' of a patient's physical condition to hundreds of pages of electronically captured data obtained over a period of weeks or months. (It can also include required check-up visits months after the patient's treatment has stopped.) The sponsor is responsible for designing a CRF that accurately represents the protocol of the clinical trial, as well as managing its production, monitoring the data collection and a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Electronic Patient-reported Outcome
An electronic patient-reported outcome (ePRO) is a patient-reported outcome that is collected by electronic methods. ePRO methods are most commonly used in clinical trials, but they are also used elsewhere in health care. As a function of the regulatory process, a majority of ePRO questionnaires undergo the linguistic validation process. When the data is captured for a clinical trial, the data is considered a form of Electronic Source Data. Methods The two main methods currently used for ePRO are computers (including smartphones) and telephone systems. ''Computers'' are most often touch-screen devices, ranging from wearables, hand-held devices and smartphones, through iPads and other Tablet computers. The smaller devices are often used as electronic diaries, designed to be used for symptom reporting on a daily basis. Larger devices are generally used in a clinic setting. Computers generally run dedicated ePRO applications - the use of the web for ePRO is not yet widespread. Typic ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Patient-reported Outcome
A patient-reported outcome (PRO) is a health outcome directly reported by the patient who experienced it. It stands in contrast to an outcome reported by someone else, such as a physician-reported outcome, a nurse-reported outcome, and so on. PRO methods, such as questionnaires, are used in clinical trials or other clinical settings, to help better understand a treatment's efficacy or effectiveness. The use of digitized PROs, or electronic patient-reported outcomes (ePROs), is on the rise in today's health research setting. Terminology PROs should not be confused with PCOs, or '' patient-centered outcomes''. The latter implies the use of a questionnaire covering issues and concerns that are specific to a patient. Instead, ''patient-reported'' outcomes refers to reporting situations in which only the patient provides information related to a specific treatment or condition; this information may or may not be of concern to the patient. Further, PROs should not be confused with PREM ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Research
Clinical research is a branch of healthcare science that determines the safety and effectiveness ( efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment. Overview The term "clinical research" refers to the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied. In the United States ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Data Management
Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical data management ensures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). The ultimate goal of CDM is to ensure that conclusions drawn from research are well supported by the data. Achieving this goal protects public health and increases confidence in marketed therapeutics. Role of the clinical data manager in a clinical trial Job profile acceptable in CDM: clinical researcher, clinical research associate, clinical research coordinator etc. The clinical data manager plays a key role in the setup and conduct of a clinical trial. The data collected during a clinical trial forms the basis of subsequent safety a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Quality Of Life
Quality of life (QOL) is defined by the World Health Organization as "an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns". Standard indicators of the quality of life include wealth, employment, the environment, physical and mental health, education, recreation and leisure time, social belonging, religious beliefs, safety, security and freedom. QOL has a wide range of contexts, including the fields of international development, healthcare, politics and employment. Health related QOL (HRQOL) is an evaluation of QOL and its relationship with health. Engaged theory One approach, called engaged theory, outlined in the journal of ''Applied Research in the Quality of Life'', posits four domains in assessing quality of life: ecology, economics, politics and culture. In the domain of culture, for example, it includes the following subdomains of ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Patient
A patient is any recipient of health care services that are performed by healthcare professionals. The patient is most often ill or injured and in need of treatment by a physician, nurse, optometrist, dentist, veterinarian, or other health care provider. Etymology The word patient originally meant 'one who suffers'. This English noun comes from the Latin word ', the present participle of the deponent verb, ', meaning 'I am suffering,' and akin to the Greek verb (', to suffer) and its cognate noun (). This language has been construed as meaning that the role of patients is to passively accept and tolerate the suffering and treatments prescribed by the healthcare providers, without engaging in shared decision-making about their care. Outpatients and inpatients An outpatient (or out-patient) is a patient who attends an outpatient clinic with no plan to stay beyond the duration of the visit. Even if the patient will not be formally admitted with a note as an outpatient, ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
