In clinical trial design, this distinguishes something that is done before the study is started. Determining specific study criteria prior to study initiation.
Absolute risk reduction
The difference in the percentage of subjects developing the adverse event in the control group versus subjects in the intervention group. Also refers to the number of subjects spared the adverse event by taking the intervention compared to the control.
A database that provides abstracts and citations for journal articles.
A synopsis (usually of 250 words or less) of the most important aspect(s) of an article.
Pertaining to a college, school, or other educational institution.
A process by which a health care educator visits a physician to provide a 15- to 20-minute educational intervention on a specific topic. Information provided is based on the physician's prescribing patterns and evidence-based medicine to improve prescribing.
Accountable care organization
A collaborative group of hospitals, doctors, and other providers of health care who coordinate their patient care efforts for Medicare patients. An emphasis is placed on minimizing duplication of effort and preventing medical errors, in particular, for the chronically ill.
A term coined by Beauchamp and Childress to refer to a hierarchical approach to analysis of an ethical issue when forming particular judgments about the issue.
A standard therapy or procedure (but not a placebo) used in a study to determine the difference in effect produced by the study intervention.
Adaptive clinical trial
A trial design, also known as group sequential design, that allows adaptation of various components such as inclusion/exclusion criteria, dosing, efficacy outcomes, and duration of trial based on continuously emerging knowledge throughout the study.
A therapy (e.g., medication, exercise, diet) that all subjects within a study receive. Since all subjects are receiving, it is not considered a study bias since the effect of this therapy occurs among all subjects within the study.
Adverse drug event (ADE)
An ADE is defined as an injury from a medicine or lack of intended medicine. An ADE refers to all adverse drug reactions (ADRs), including allergic or idiosyncratic reactions, as well as medication errors that result in harm to a patient.
Adverse drug event (ADE) monitoring
Computer programs that use electronic data and predetermined rules to identify when an ADE may have occurred or is about to occur.
Adverse drug event (ADE) trigger tool
It is an augmented chart review method that uses automated systems to identify alerts or triggers to efficiently identify patients with potential ADEs. The triggers are cues that a patient may have experienced an error and/or adverse event. When these triggers are identified, it is suspected that the patient may have experienced a medication error. The patient's chart is reviewed for evidence of error and/or level of harm and data are collected and collated to determine potential common causes.
Adverse drug reaction (ADR)
Defined broadly, any unexpected, unintended, undesired, or excessive response to a medicine. The Food and Drug Administration's (FDA) definition of ADRs is: “any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following: adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose, whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any significant failure of expected pharmacologic action.” Adverse drug reactions also include drug interactions. Defined by the World Health Organization (WHO) as “any response that is noxious, unintended, or undesired, which occurs at doses normally used in humans for prophylaxis, diagnosis, therapy of disease or modification of physiological function.” Several other definitions are available; many of those are discussed in Chapter 15.
Agenda for Change
An initiative adopted by the JCAHO in 1986 intended to improve standards by focusing on key functions of quality of care, to monitor the performance of health care organizations using indicators, improve the relevance and quality of the survey process, and enhance the accuracy and value of JCAHO accreditation.
Provide a summary of the frequency, or timeliness, of a process by aggregating numerous cases.
A piece of software that is used to automatically collect information from RSS and Weblog sites, which allows the user to look at material from many of those sites at one time and in one place.
A situation in which clinical decision support system (CDSS) alerts and warnings appear too frequently resulting in a provider ignoring or overriding these messages.
A situation in which clinical decision support system (CDSS) alerts and warnings appear too frequently resulting in a provider ignoring or overriding these messages.
Alpha (level of significance)
The probability of a false positive result in a study. Criterion for rejecting the null hypothesis. It is the upper bound of the Type I error rate. The value (usually 0.05) that is set prior to the beginning of a study and in which the p-value is compared at the end of the study to determine if statistical difference is present in the outcome being measured. A p-value less than alpha (e.g., 0.001 < 0.05) is interpreted as a statistical difference was determined between the intervention and control groups of a study. Also is the amount of error the researchers are willing to accept that a false-positive result is identified between the study intervention and control groups (e.g., alpha of 0.05 is up to a 5% chance of a false-positive result).
Sometimes referred to as the research hypothesis. The hypothesis that states there is some difference or relationship between the therapy under investigation and the control.
An approach to health care outside conventional medicine. Alternative medicine refers to using a nonmainstream approach in place of conventional medicine.
American Hospital Formulary System (AHFS) classification
A classification that can be found in the AHFS Drug Information reference book, published by the American Society of Health-Systems Pharmacists. It groups agents by use and/or drug class into specific numbered categories (e.g., 24:32.04 Angiotensin-Converting Enzyme Inhibitors).
Analysis is the critical assessment of the nature, merit, and significance of individual elements, ideas, or factors. Functionally, it involves separating the information into its isolated parts so that each can be critically assessed. Analysis requires thoughtful review and evaluation of the quality and overall weight of available evidence.
Quantitative research conducted in a controlled environment to determine cause-and-effect relationships.
A therapy (e.g., medication, exercise, diet) that is disproportional in use among the subjects in the groups within a study and has an effect on the outcome being measured; this can lead to a difference in effect between the groups, which can bias the study results.
Antibiotic use review (AUR)
Retrospective evaluation of antibiotic use. Usually quantitative and limited to identifying patterns of use.
Application service provider (ASP)
See Software as a Service (SaaS).
Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument
A structured instrument to assess the quality of guidelines, provide a methodological strategy for the development of guidelines, and inform what information and how information ought to be reported in guidelines.
A letter asking the publisher whether they would be interested in possibly publishing something on a particular topic written by the person(s) who are inquiring.
Aspect of care
A term used in quality assurance programs to indicate the title that describes the area being evaluated.
The process of ensuring that a drug truly has a notable effect by utilizing high-quality clinical trials of the drug against placebo.
Assumption of the risk
A defense in the law of torts, which bars a plaintiff from recovery against a negligent party if the defendant can demonstrate that the plaintiff voluntarily and knowingly assumed the risks at issue inherent to the dangerous activity in which he or she was participating at the time of his or her injury.
The difference in the rate of a condition when comparing an exposed population to an unexposed population. This is primarily used in cohort studies and is considered an epidemiological term.
Automated dispensing cabinets (ADCs)
Automated devices with a range of functions. Core capabilities include medication storage and retrieval for administration to patients, especially in patient care areas, as well as audit trails of cabinet access. Other functions can include medication charging and automated inventory management.
Autonomy is the personal rule that is free from both controlling interferences by others and from personal limitations that prevent meaningful choice. Autonomous individuals act intentionally, with understanding, and without controlling influences.
A movable three-dimensional image used to represent some body in cyberspace.
Bar code verification
The use of bar code scanning to ensure that the correct drug, strength, and dosage form were dispensed in the drug selection process and the five basic patient rights (i.e., right patient, right drug, right dose, right route, right time) are followed at the point of care.
A basic principle of consequentialist theory that expresses the duty to promote good.
A type of selection bias noted in case-control studies and is produced when the probability of hospitalization of cases and controls differs. This probability can be increased based on the specific exposure being studied and increases the chance of hospital admission.
The probability of a false-negative result in a study.
An intentional or unintentional systematic error in the way a study is designed, conducted, analyzed, or reported.
A list of references, usually seen at the end of a piece of professional writing.
Biocreep (also known as placebo creep)
The phenomenon that results in the reference drug becoming no better than placebo in NI trials. This occurs when a somewhat inferior test drug is chosen as the reference drug for a future generation of NI trials. After multiple generations of this occurring, the final result is a future reference drug that is no better than placebo.
Research that evaluates whether products are similar in rate and extent of absorption.
Biologics license applications (BLA)
A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology, and the medical effects of the biologic product. It is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce.
Black letter rules
Principles of law that are known generally to all and are free from doubt and ambiguity. Also known as hornbook law, since they are in a format that would probably be enunciated in a hornbook.
A study technique used in research to reduce bias by having the study subjects and/or investigators not know which group the study subjects are assigned.
Body area network (BAN)
A multidevice, interconnected computer system carried on a person. Sometimes referred to as a wearable computer.
Boolean operators (logical operators)
Words used to combine search terms (i.e., AND, OR, NOT) when using computerized databases.
The aggregate of reported cases; the law pertaining to a particular subject as formed by adjudged cases.
A descriptive record of a single individual (case report) in which the possibility of an association between an observed effect and a specific intervention or exposure is described (often an unexpected complication of treatment or procedure) based on detailed clinical evaluation and history of the individual.
A grouping of records (case studies) that documents a practitioner's experiences, thoughts, or observations related to the care of multiple patients with similar medical situations.
A record of descriptive research that documents a practitioner's experiences, thoughts, or observations related to the care of a single patient. Not useful to test a hypothesis but can serve to generate pilot information to design future controlled trials.
A retrospective trial design (often using medical charts or cases) strictly based on the observation of a group of people that have experienced a similar outcome. The study is used to determine the possible exposure these patients have had, which would lead to this known outcome.
A variable measured on a nominal or ordinal scale.
See Compact disc-read only memory.
Negligent acts and/or omissions, other than breach of contract, normally independent of moral obligations for which a remedy can be provided in a court of law. This form of liability is imposed under civil laws and processes, not criminal law. For example, a person injured in someone's home can bring suit under civil liability law.
Clinical decision support systems (CDSS)
Computer programs that augment clinical decision making by combining referential information with patient-specific information to prevent negative actions and update providers of patient status.
Any experiment in which a drug is administered or dispensed to one or more human subjects. An experiment is any use of a drug (except for the use of a marketed drug) in the course of medical practice. Although there are many other definitions, this is the FDA's definition and would seem the appropriate one to use given the nature of this topic. Please note that the FDA does not regulate the practice of medicine and prescribers are (as far as the agency is concerned) free to use any marketed drug for off-label use.
Clinical practice guidelines
Recommendations for optimizing patient care that are developed by systematically reviewing the evidence and assessing the benefits and harms of health care interventions.
Clinical response letters
Written correspondence that contains company-approved content in response to an unsolicited request for medical information.
Clinical Safety Officer (CSO)
Also known as the regulatory management officer (RMO). This will be the sponsor's Food and Drug Administration contact person. Generally, the CSO/RMO assigned to a drug's investigational new drug application will also be assigned to the new drug application.
The clinical importance of data generated in a study, irrespective of statistical results. Usually refers to the application of study results into clinical practice. Also, can be called clinical meaningfulness.
A result large enough to cause an effect on an efficacy outcome measure that noticeably changes a patient's condition.
A drug formulary that restricts the drugs available within an institution or available under a third-party plan.
Any individual who writes a portion of an article, chapter, book, etc. This includes individuals other than the primary author, whose name is normally listed first on a publication.
A prospective trial design strictly based on the observation of a group of people who experience a known exposure over time. The study is used to determine outcomes to this exposure.
An IND for which the sponsor is usually either a corporate entity or one of the institutes of the National Institutes of Health (NIH). In addition, CDER may designate other INDs as commercial, if it is clear the sponsor intends the product to be commercialized at a later date.
See Locality rule.
Compact disc-read only memory (CD-ROM)
A storage and retrieval system for large quantities of computerized data. Modern computers usually cannot only read the data on these disks, but usually can write new data to disks designed to accept that new data.
The allocation of responsibility for damages incurred between the plaintiff and the defendant, based on the relative negligence of the two.
Complementary and alternative medicine
An approach to health care outside conventional medicine. Complementary medicine refers to using a non-mainstream approach together with conventional medicine. Alternative medicine refers to using a non-mainstream approach in place of conventional medicine.
A measure of how well instructions are followed. In a study, compliance refers to how well a patient follows instructions for medication administration and how well the investigator follows the study protocol.
An interconnection of computers and computer-related devices (e.g., printers, modems) that allows the devices to interchange data, electronic mail, programs, and other files. In addition, a network allows sharing of peripheral devices, such as printers, modems, fax boards, etc. Normally, this interconnection is via a dedicated wiring system (other than telephone/modem communication); however, wireless connections are becoming common.
Computer-based clinical decision support systems
software that is designed to assist clinical decision making which utilizes both patient-specific information and clinical knowledge to make assessments or recommendations in clinical practice.
Computerized provider order entry (CPOE)
A process allowing medical provider instructions to be electronically entered for the treatment of patients who are under a provider's care.
An indicator used in any quality assurance program that determines whether quality is acceptable while an action is being taken or care is being given.
The wrongful acts or omissions of two or more persons acting independently, but causing the same injury.
Range calculated for a study result in which the true value for the population exists; the percentage association with the range (e.g., 95%) indicates the confidence in which the true population value is within the range. For instance, the investigators are 95% confident that the mean blood pressure lowering effect of the medication for the population is between −8 to −12 mmHg for the 95% confidence interval of (−8 to −12 mmHg).
A moral rule, related to the principle of autonomy, which specifically addresses the individual client's right to give or refuse consent relative to release of privileged information.
Conflict of interest
A situation in which the interests of an investigator conflicts with the study purpose, design, and/or result interpretation. An investigator may be a stock holder of and/or speaker for a pharmaceutical company; the study may be designed to produce favorable results and/or be interpreted or promoted with a bias to use the study intervention.
A known or unknown variable that has the potential to mask actual associations or falsely demonstrate a nonexisting but apparent association between the defined related variable (exposure) and outcome(s) being studied. The real issue occurs when the confounder is unevenly distributed between the exposure and nonexposure study groups, leading to confusion interpreting the results. Unevenly distributed confounders are common in cohort studies since this imbalance is the product of not using a randomization schedule that evenly distributes the confounder between the groups.
A moral rule related to the principle of autonomy which states that the client has a right to be informed and to freely choose a course of action.
Also called special damages; damages claimed and/or awarded in a lawsuit which were caused as a direct foreseeable result of wrongdoing. Consequential damages occur with injury or harm that does not ensue directly and immediately from the act of a party, but only from some of the results of such act, and that is compensable by a monetary award after a judgment has been rendered in a lawsuit.
An ethical theory which holds that the rightness or wrongness of decisions or actions is determined by the total of good that is achieved or harm that is prevented.
A determination made that past studies being used to determine the noninferiority (NI) margin in an NI trial are similar in design and conduct compared to the NI trial regarding features that could alter the effect size of the reference drug compared to placebo.
Consumer health information (CHI)
Information actively sought by the patient in response to their need for more information about their health. Information is not individualized for a specific patient but rather general health information.
A term used to limit a search to specific things, such as specific drugs or disease states.
Provide a simple count, or time estimate, related to a process (e.g., average turnaround time on medication orders).
Continuous quality improvement (CQI)
The term given to the methodologies used in the process of Total Quality Management. Efforts to improve quality are part of each participant's responsibilities on an ongoing basis.
A variable measured on an interval or ratio scale.
Contract research organization (CRO)
An individual or organization that assumes one or more of the obligations of the sponsor through an independent contractual agreement.
The group of test animals or humans that receive a placebo (a dosage that does not contain active medicine) or active (a dosage that does contain active medicine) treatment. For most preclinical and clinical trials, the FDA will require that this group receive placebo (commonly referred to as the placebo control). However, some studies may have an active control, which generally consists of an available (standard of care) treatment modality. An active control may, with the concurrence of the FDA, be used in studies where it would be considered unethical to use a placebo. A historical control is one in which a group of previous patients is compared to a matched set of patients receiving the new therapy. A historical control might be used in cases where the disease is consistently fatal (i.e., acquired immunodeficiency syndrome [AIDS]). (Refer to Chapter 4 for additional information on control groups).
Controlled clinical trial
Research design that prospectively and directly compares plus measures and quantifies differences in outcomes between an intervention and control. This is the best study design to determine a cause-and-effect relationship between an item under investigation and an outcome.
A treatment (placebo, active, historical) used for comparison in a study to measure a difference in effect against an investigational agent. The investigator usually wishes to determine superiority of a new treatment over the control in terms of efficacy and safety.
Payment made by an individual who has health insurance at the time the service is received to offset the cost of care. Copayments may vary depending on the service rendered.
Cost-benefit analysis (CBA)
A study where monetary value is given for both costs and benefits associated with a drug or service. The results are expressed as a ratio (benefit-to-cost), and the ratio is used to determine the economic value of the drug or service.
A study where monetary value is given for both costs and benefits associated with a drug or service. The results are expressed as a ratio (benefit to cost), and the ratio is used to determine the economic value of the drug or service.
Cost-consequence analysis (CCA)
An informal variant of a cost-effectiveness analysis (CEA). The costs and various outcomes are listed but no evaluations are conducted.
Cost-effectiveness analysis (CEA)
A study where the cost of a drug or service is compared to its therapeutic impact. Cost-effectiveness studies determine the relative efficiency of various drugs or services in achieving desired therapeutic outcomes.
Cost-effectiveness ratio (CER)
The CER is the ratio of resources used per unit of clinical benefit, and implies that this calculation has been made in relation to doing nothing or no treatment.
A study where the cost of a drug or service is compared to its therapeutic impact. Cost-effectiveness studies determine the relative efficiency of various drugs or services in achieving desired therapeutic outcomes.
A study that compares costs of drugs or services that have been determined to have equivalent therapeutic outcomes.
Cost-utility analysis (CUA)
A study that relates therapeutic outcomes to both costs of drugs or services and patient preferences, and measures cost per unit of utility. Utility is the amount of satisfaction obtained from a drug or service.
A study that relates therapeutic outcomes to both costs of drugs or services and patient preferences and measures cost per unit of utility. Utility is the amount of satisfaction obtained from a drug or service.
An ethical covenant in medical ethics suggests an implicit contract between the client and the health care provider that broadly describes the relationship involved whenever a health care service is provided, including the provision of information. Within this contract the service recipient has a right to competently provided service, as well as respectful treatment. The service recipient also has an obligation to provide needed information to the provider in a respectful manner.
It is a bias in a statistic that occurs when the target population you want to survey does not coincide with the sample population that is actually surveyed. This can be an issue when observing a sample of the population instead of the entire population.
Criteria for specific drugs determined by the health plan in conjunction with the pharmacy and therapeutics committee that is used to determine if a prescription is covered. Criteria are based on evidence-based medicine.
See Continuous quality improvement.
Definitions of safe and effective use of medications used to assess components of the medication use process that are endorsed by the organization within which they are to be applied. Criteria summarize an organization's definition of appropriate or acceptable use of the medication.
A study where each subject receives all study treatments, and endpoints during the various treatments are compared.
Data that is measured one time.
A trial design involving data collection only once on members of the study population that represents a snapshot in time. These members are not required to be studied all at once, but each member can be studied at a different time. The key is that the data collected represents a specific period in time.
A concept broader than telemedicine that includes the marketing, relationship creation, advice, prescribing, and selling pharmaceuticals and devices in cyberspace.
In relation to adverse drug reactions, this occurs when the drug is taken away and the patient is monitored to determine whether the adverse drug reaction (ADR) abates or decreases in intensity.
A tool that can help visualize a pharmacoeconomic analysis. It is the application of an analytical method for systematically comparing different decision options. Decision analysis graphically displays choices and performs the calculations needed to compare these options.
Practical consideration that involves the naming of additional codefendants in personal injury lawsuits to provide assurance to the plaintiff that there will be sufficient assets to pay the judgment.
Degrees of freedom
The number of data points that are free to vary.
The amount of difference that the investigators wish to detect between intervention and control groups in a study.
An ethical theory that seeks to establish what is a right or wrong decision or action on the basis of prioritizing specific recognized ethical rules or principles.
Quantitative research that describes naturally occurring events.
Statistics that describe data such as medians, modes, and standard deviations.
Diagnostic review bias
It occurs when the reference test results are not definitive and the study test results affect or influence how the final diagnosis is established.
See Drug information center.
A variable that has two mutually exclusive categories.
Digital video disk (DVD)
Also known as digital versatile disk. A disk that physically resembles a CD-ROM, but allows the storage of much larger amounts of data. It requires a special reading/
writing device in a computer, although this device may also be combined with that used for CD-ROMs. DVDs have been used to a large extent to store and replay movies; however, it is being used on computers to store large amounts of computer data, particularly large multimedia files.
Direct medical costs
One of four categories of costs in pharmacoeconomic studies. These are the medically related inputs used directly in providing the treatment.
Direct nonmedical costs
One of four categories of costs in pharmacoeconomic studies. These are costs directly associated with treatment, but are not medical in nature. Examples include travel, food, and lodging to get to a place of treatment.
See Drug information service.
A term from finance which approximates the cost of capital by taking into account both the projected inflation rate and the interest rates of borrowed money, and then estimates the time value of money.
Drug class review
A drug evaluation monograph comparing all products in a particular class of drugs. It is used to determine what products will be available for use.
Drug evaluation monograph
A structured document covering all aspects of a particular drug product or class of drugs. It compares similar agents and is used to determine which products will be available for use.
Drug formulary system
See Formulary system.
The electronic management of drug information.
Facts or advice on drugs (including chemicals that has medicinal, performance-enhancing or intoxicating effects) regarding a specific patient or a group of patients.
Drug information center (DIC)
A physical location where pharmacists have the resources (e.g., books, journals, computer systems, etc.) to provide drug information. This area is generally staffed by a pharmacist specializing in drug information, but may be used by a variety of the pharmacy staff or other individuals.
Drug information service
A professional service providing drug information. This service is normally located in a drug information center.
The Food and Drug Administration defines this as “a pharmacologic response that cannot be explained by the action of a simple drug, but is due to two or more drugs acting simultaneously.”
Drug master file (DMF)
A submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
The final dosage form prepared from the drug substance.
Information provided by the pharmaceutical industry through advertising, detailing, and other printed material intended to increase sales of a medication.
Drug regimen review (DRR)
The monthly evaluation of nursing home charts by pharmacists.
Bulk compound from which the drug product is prepared. An active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body.
Drug use evaluation (DUE)
Concurrent evaluation of prescribing and outcome only. Multidisciplinary involvement.
Drug use review (DUR)
A program related to outpatient pharmacy services designed to educate physicians and pharmacists in identifying and reducing the frequency and patterns of fraud, abuse, gross overuse, or inappropriate or medically unnecessary care. DUR is typically retrospective in nature and utilizes claims data as its primary source of information.
See Reasonable care.
A moral or legal obligation.
A commentary usually written by an expert that describes study strengths and limitations plus the application of the study results to practice. This is published in the same journal issue as the study, but not all studies have an accompanying editorial.
Electronic mail (e-mail)
Brief messages sent from one computer to another, similar in use to interoffice memos. This serves as a quick, informal method of written communication. Also, e-mail may be used to send other items, such as word processing files, graphics, video, etc., to others.
Electronic medication administration record (eMAR)
An electronic version of the traditional medication administration record. It supports patient safety by incorporating clinical decision support and bar-coded medication administration. It also enables real-time documentation and billing of medication administration.
Electronic prescribing (e-prescribing)
Prescription entered by a prescriber directly into an electronic format using agreed-upon standards, which is securely transmitted to the pharmacy that the patient chooses. Faxes and printed prescriptions are not e-prescriptions.
See Electronic mail.
A parameter measured in a clinical study. The primary endpoint is the major variable analyzed and reflects the main objective of the study. Secondary endpoints are additional variables of interest monitored during clinical studies.
See Primary endpoint.
See Secondary endpoint.
Error, Type I
See Type I error.
Error, Type II
See Type II error.
Integrated bodies of principles and rules that may include mediating rules that govern cases of conflicts.
The philosophical inquiry of the moral dimensions of human conduct. An ethical issue involves judgments between right and wrong human conduct or praiseworthy and blameworthy human characters.
Ethics (defined by AACP)
Philosophical inquiry into the moral dimensions of human conduct.
Ethics (defined by Beauchamp and Childress)
A generic term for several ways of examining the moral life.
Evidence-based medicine (EBM)
A philosophy of practice and an approach to decision making in the clinical care of patients that involves making individual patient care decisions based on the best currently available evidence.
Characteristics of subjects defined prior to starting the study that are used as parameters to disqualify subjects from enrolling in the study (e.g., patients with cancer, lactating females, patients receiving corticosteroid therapy).
An exculpatory clause is part of an agreement which relieves one party from liability. It is a provision in a contract which stipulates (1) one party is relieved of any blame or liability arising from the other party's wrongdoing, or (2) one party (usually the one that drafted the agreement) is freed of all liability arising out of performance of that contract. An exculpatory clause will not be enforced when the party protected by the clause intentionally causes harm or engages in acts of reckless, wanton, or gross negligence or when found to be unreasonable under the particular circumstances (e.g., a restaurant checks a person's coat but the ticket states they are not responsible for loss or damage).
Research of a qualitative nature in which the investigators examines an unknown area to generate hypotheses.
The practice of compounding prescriptions from a list of several ingredients—usually performed by a pharmacist.
Quality of the study design that allows the result to be applied to practice. Study results are meaningful to practitioners and can be used for patient care.
Failure mode and effects analysis (FMEA)
FMEA is a structured proactive method of evaluating a process to identify the gaps—how the process might fail. The process includes identification of the likelihood of each of the failures along with its relative impact to the patient. This provides a prioritization of action plans to drive improvement and reduce the likelihood of failure.
A quality of drug promotions where similar attention is given to safety risks (e.g., contraindications, precautions/warnings, adverse effects) and efficacy benefits.
Individuals with the disease who were incorrectly identified as being disease free by the test.
Individuals without the disease who were incorrectly identified as having the disease by the test.
A directed, highly individualized postgraduate training program designed to prepare the participant to function as an independent investigator. The purpose of fellowship training programs is to develop competency and expertise in the scientific research process, including hypothesis generation and development, study design, protocol development, grantsmanship, study coordination, data collection, analysis and interpretation, technical skills development, presentation of results, and manuscript preparation and publication. A fellowship candidate is expected to possess appropriate practice skills relevant to the knowledge area of the fellowship. Such skills may be obtained through prior practice experience or completion of a residency program.
A principle of moral duty in deontological theory that addresses the responsibility to be trustworthy and keep promises.
File transfer protocol (FTP)
A method to transfer files from one computer to another.
A study where subjects exposed to a factor and those not exposed to the factor are followed forward in time and compared to determine the factor's influence on disease state development. Also called a cohort study.
Food and Drug Administration (FDA)
The agency of the U.S. government that is responsible for ensuring the safety and efficacy of all drugs on the market.
A preferred method to display the results from a meta-analysis and includes the 95% confidence intervals for the primary efficacy outcome for each study included in the meta-analysis with the overall resulting 95% confidence interval for the meta-analysis.
A continually revised list of medications that are readily available for use within an institution or from a third-party payer (e.g., insurance company, government) that reflects the current clinical judgment of the medical staff or the payer. Restrictions on this list may be placed that indicate certain drugs will not be reimbursed by insurance, or will only be reimbursed if several other alternative are tried first.
Formulary decision supports (FDS)
Program (often software) used to enhance compliance with formulary by guiding the prescriber to preferred formulary drugs over those considered nonformulary.
A method used to develop a drug formulary. It is sometimes even thought of as a philosophy.
A scatter plot of treatment effect versus sample size of studies included in a meta-analysis. They are used to assist in detecting potential publication bias which is a form of selection bias based on the magnitude, direction, or statistical significance of the study results.
A copy of a written work as it is to be published. The purpose of this document is to allow the author(s) to make a final check to ensure everything is correct before actual publication.
Project management tool used to plan and monitor elements of a project.
Showing favoritism or discrimination toward a selected gender.
Good clinical practice (GCP)
A standard for the design, conduct, monitoring, analyses, and reporting of clinical trials that provides assurance that the results are credible and accurate, and that the rights of study subjects are protected.
Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) system
A standardized system for grading the quality of the evidence and the strength of recommendations in clinical practice guidelines.
Documents provided in limited numbers outside the formal channels of publication and distribution. The concern with these documents in that they may include inaccurate information (not completely correct information), misinformation (incorrect information), and disinformation (false information deliberately provided in order to influence opinions) that can confound study results.
The utilization of health care related tools provided by Web 2.0.
Health applications (apps)
Software for devices designed to manage various aspects of health for the specific user.
Health Insurance Portability and Accountability Act of 1996
Commonly referred to as HIPAA, this act includes privacy restrictions for electronic health records.
It is the capability of patients to read or hear health information, understand it, and then act on health information.
Health maintenance organization (HMO)
Form of health insurance whereby the member prepays a premium for the HMO's health services, which generally include inpatient and outpatient care.
Health Plan Employer Data and Information Set (HEDIS)
A set of performance measures used to compare managed health care plans.
Health product information
Identified by Project Destiny as a service area where as pharmacists augment patient's health care by providing information to patients based on information from prescription history, patient profiles, and purchases.
Health-related quality of life (HR-QOL)
Term used to represent the value assigned to quality and quantity of life that can be modified by various factors such as impairments and perceptions that are caused by disease, injury, treatment, or medical policy.
Noted in meta-analyses, this describes a situation where there are differences in the way the studies being included in the meta-analysis were conducted. Ideally, all studies included should be identical in design and the way they are conducted (same doses used, same inclusion/exclusion criteria, same outcome measurements, same duration, etc.). There can be different degrees of heterogeneity; however, if there are significant variations in true effects underlying the studies, then the meta-analysis results are in question.
See Health Insurance Portability and Accountability Act of 1996.
A central ethical tradition of Western medicine that is committed to producing good for one's patient and protecting that patient from harm. There is a special emphasis placed on the responsibility of the medical professional to the specific patient.
Data used in research that were collected prior to the decision to conduct the study (e.g., medical records, insurance information, Medicaid databases).
Historical evidence of sensitivity to drug effects (HESDE)
In noninferiority trials this concept applies to appropriately designed and conducted past trials using the reference drug and regularly exhibiting the reference drug to be superior to placebo.
See Health maintenance organization.
As used with meta-analyses, homogeneity measures the differences or similarities between the several studies included in the meta-analysis. Ideally, all studies included should be identical in design and the way they are conducted (same doses used, same inclusion/exclusion criteria, same outcome measurements, same duration, etc.).
Tests used when conducting a meta-analysis to determine the similarity of studies whose results were combined for the analysis.
In correlation and regression, the variability around the best fit line of the linear relationship is constant across all data points.
http—hypertext transfer protocol
A method by which information is encoded and transmitted on the World Wide Web.
A secure form of http, used to transmit confidential information, such as credit card numbers.
Also called a link; it is a word, group of words, or image that can be clicked on to jump (link) to another place within the same document or to an entirely different document. When you move the cursor over a link in a Web site, the arrow will turn into a little hand. Hyperlinks are the most essential ingredient of all hypertext systems, including the Internet.
The researchers' assumptions regarding probable study results. The research hypothesis or alternative hypothesis (HA) is the expectations of the researchers in terms of study results. The null hypothesis (HO) is the no difference hypothesis, which assumes equality amongst study treatments. The null hypothesis is the basis for all statistical tests and must be rejected in order to accept the research hypothesis. In vitro
Experiments conducted using components of an organism that have been isolated from their usual biological surroundings. These types of experiments are also referred to as “test tube experiments.” In vivo
Experiments conducted in living organisms in their intact state.
Measures the probability that a healthy person will develop a disease within a specified period of time. It is the number of new cases of disease in the population over a specific time period.
Characteristics of subjects defined prior to starting the study that are used as parameters to enroll participants in the study (e.g., males and females between 50 and 75 years of age with a prior myocardial infarction).
Incremental cost-effectiveness ratio (ICER)
Is the ratio of the change in costs to incremental benefits of a therapeutic intervention or treatment.
Independent data monitoring committee
A group of experts that are independent of the ongoing clinical study they are monitoring. This group looks at the blinded data being generated by the study to determine if changes or adjustments should be made about how the study is being conducted.
A searchable database of biomedical journal citations.
A drug that, when prescribed, may offer evidence that an adverse effect to a drug may have occurred. Pharmacists can then investigate further to determine whether there really was an adverse effect. Examples are found in Chapter 17.
Measures or screens for quality and can focus on structure, process, or outcomes.
Indirect medical costs
One of four categories of costs in pharmacoeconomic studies. Indirect costs involve costs that result from the loss of productivity due to illness or death.
Also known as the reasoning engine, this forms the brain of the clinical decision support system, working to link patient-specific information with information in the knowledge base. It evaluates the available information and determines what to present to the user.
Statistics (i.e., parametric and nonparametric tests) that determine the statistical importance of differences between groups and allow conclusions to be drawn from the data.
An individual that has advanced medication information skills with a keen understanding of computer and information technology.
Evidence-based patient education and/or medical information presented at an appropriate time to most effectively assist the patient in making a specific health decision or change in their behavior.
The document signed by a subject, or the subject's representative, entering into a trial that informs him or her of his or her rights as a research subject, plus potential benefits and risks of the trial. This document indicates that the person is willing to participate in the study.
Inherent drug risks
Are unique to the drug and usually identified in the package insert, but do not include probable or common side effects.
A judicial remedy issues in order to prohibit a party from doing or continuing to do a certain activity.
Institutional Review Board (IRB)
A group of individuals from various disciplines (e.g., lay people, physicians, pharmacists, nurses, clergy) who evaluate protocols for clinical studies to assess risks to the research participants and benefits to society. Approval of a local IRB (i.e., an IRB located in the community in which the study is to be conducted) is necessary prior to initiation of a clinical study involving patients.
One of four categories of costs in pharmacoeconomic studies. Includes such items as the costs of pain, suffering, anxiety, or fatigue that occur because of an illness or the treatment of an illness.
Intelligent infusion (smart) pumps
Infusion pumps containing software designed to help eliminate pump programming errors.
A study design technique used to include results of all subjects in the final analysis even when the subject does not complete the entire study.
Analysis of all subject results randomized in a clinical trial regardless of whether they completed or dropped out of the study.
Evaluation of data at specified time points before scheduled termination or completion of a study.
Internal validity refers to the extent to which the study results reflect what actually happened in the study (i.e., appropriate and sound study methods).
A worldwide computer network.
The ability of disparate computer systems to exchange information in a manner that allows the information to be used meaningfully.
Data in which each measurement has an equal distance between points, but an arbitrary zero (e.g., temperature in Fahrenheit).
A scale of measurement that has rank ordered data with meaningful distance between two ranks, but no natural zero.
A study where the investigator introduces a factor and examines the factor's influence on certain variables or outcomes.
A computer network with restricted access, as within a health-system.
Inverse variance test
A statistical test commonly used to combine continuous data in meta-
Investigational device exemption (IDE)
An approved IDE means that the IRB (and FDA for significant risk devices) has approved the sponsor's study application and all requirements under 21CFR812 are met. It allows the use of a device in a clinical investigation to collect safety and effectiveness data.
Investigational new drug
A drug, antibiotic, or biological that is used in a clinical investigation. The label of an investigational drug must bear the statement: “Caution: New Drug-Limited by Federal (or United States) law to investigational use.”
Investigational new drug application (IND)
A submission to the FDA containing chemical information, preclinical data, and a detailed description of the planned clinical trials. Thirty days after submission of this document to the FDA by the sponsor, clinical trials may be initiated in humans (unless a clinical hold is placed by the FDA). When the FDA allows the studies to proceed, this document allows unapproved drugs to be shipped in interstate commerce.
The individual responsible for initiating the clinical trial at the study site. This individual must treat the patients, ensure that the protocol is followed, evaluate responses and adverse reactions, solve problems as they arise, and ensure proper conduct of the study.
Joint Commission on Accreditation of Healthcare Organizations. See The Joint Commission.
Joint and several liability
Refers to the sharing of liabilities among a group of people collectively and also individually. If the defendants are “jointly and severally” liable, the injured party may sue some or all of the defendants together, or each one separately, and may collect equal or unequal amounts from each.
Just Culture is a term coined by David Marx, which is a structured accountability model that supports patient safety and a learning culture. It is intended to balance recognition and understanding of system contribution to errors with an understanding of human error concepts in order to facilitate an accountability process that is valued by leadership and staff. When applied consistently and fairly it is also a proactive approach to identifying gaps in system processes.
A concept that relates to fairness and tendering what is due, resource allocation, and providing that to which the individual is entitled.
Key opinion leaders
Health care professionals considered to be experts in their area by their peers. Key opinion leaders are often highly regarded for their expertise in publications, speaking engagements, and influential value in the medical community.
Refers to how flat or peaked the curve appears. A curve with a flat or board top is referred to as platykurtic while a peaked distribution is described as leptokurtic.
Occurs when only specific articles are included in a review or study that are published in a specific language such as the review author's native language. The issue is that potentially important articles are eliminated from the review.
Involves written rules set by the whole society, or its representatives, that address the responsibilities of that society's members.
A doctrine of products liability law and personal injury law; the manufacturer of a prescription drug fulfills its duty to warn of potentially harmful effects of the drug by informing the prescribing physician and is not also obligated to warn the user. The prescribing physician acts as a learned intermediary between the manufacturer and the consumer and has the primary responsibility of warning patients of the hazards of prescribed pharmaceutical products. This doctrine is an exception to the rule that one who markets goods must warn foreseeable ultimate users of dangers inherent in their products.
Comments from readers of a study or other article published in a journal. These are published in a latter issue of the same journal and usually have a reply from the original study/article author(s). Occasionally, short reports of a case or small study may be reported this way.
Level of evidence
A scale used to categorize the overall quality of a specific clinical trial. The reliability of the results can be inferred from the category given a trial.
Life table methods
In the context of cohort study life tables, data are collected by following patients throughout their lives or a specific duration of their life and then compiled into tables for such uses as survival or mortality analyses comparing exposed to nonexposed situations.
A service offered by some e-mail systems that allows a member of the listserver to send an e-mail message to one particular Internet address where it will be sent to all members of the listserver. This acts as a dynamic distribution list for e-mail messages.
Local area network (LAN)
A group of computers connected in a way that they may share data, programs, and/or equipment over a small geographic area (e.g., building, department).
Legal doctrine created in the latter part of the nineteenth century that stated that the local defendant practitioner would have his or her standard of performance evaluated in light of the performance of other peers in the same or similar communities. Also known as community rule.
A term such as AND, OR, NOT, NEAR, or WITH that can be used in searching a computer database.
A linear transformation of probability. That is, probability is bounded between 0 and 1, log-odds transform probability to a continuous scale ranging from −∞ to +∞. The log-odds become the dependent variable in logistic regression.
Data that is measured repeatedly over time.
Level of decision-making sets policy for the health system, as a standard established for an entire profession, or through government as law/regulation for the society as a whole.
Mail service drug program
Program that provides free home delivery for up to a 90 day supply of maintenance prescription drugs.
A large centralized computer that is used via computer terminals or other devices. This term is becoming blurred as smaller computer systems gain greater capabilities.
Managed care organization (MCO)
Health care provider who contracts with participating providers to provide a variety of services to enrolled members.
Statistical test commonly used to combine categorical data in meta-analyses.
Marginal (or incremental) cost-utility ratio
It is the gain in a benefit from an increase, or loss from a decrease, in a good or service, such as the quality-adjusted life years (QALY). It is calculated to estimate the added cost for an added benefit, not calculated when the added benefit comes at a lower cost.
Marginal cost-effectiveness ratio
The additional cost of one unit expansion of a single intervention.
A statistical technique which is used to evaluate the effect of a treatment by comparing the treated and nontreated units in an observational study such as case-control studies. The goal is to identify a nontreated patient with similar observable characteristics for every treated patient (cases and controls are similar), so treatment effect can be measured more accurately.
Material issue of fact
Genuine issue of material fact is a legal term often used as the basis for a motion for summary judgment. A summary judgment is proper if there is no genuine issue of material fact and the movant is entitled to a judgment as a matter of law. Such a motion will be granted if the party making the motion proves there is no genuine issue of material fact to be decided. When the moving party makes a prima facie showing that no genuine issue of material fact exists, the burden shifts to the nonmoving party to rebut the showing by presenting substantial evidence creating a genuine issue
See Managed care organization.
Mean (arithmetic mean)
The most common measure of central tendency for data measured on an interval or ratio scale and is best described as the average numerical value for the data set. Calculated as the sum of the observations divided by the number of observations. The arithmetic average of a set of numbers.
A set of standards defined by the CMS as the use of certified EHR technology to (1) improve quality, safety, and efficiency, (2) engage patients and their families, (3) improve care coordination, as well as public and population health, and (4) maintain privacy and security of PHI.
Occurs when the collection of data is influenced by the interviewer or when the survey item itself is unclear from the respondent's point of view.
Measures of association
Calculation and interpretation of nominal study results using relative risk (RR), relative risk reduction (RRR), absolute risk reduction (ARR), and numbers needed to treat (NNT).
The absolute middle value of a set of number.
Medical executive committee
A committee that acts as the administrative body of a medical staff in an institution. It is responsible for overseeing all aspects of care within the institution. This committee may be known by other names at specific institutions.
Medical Literature Analysis and Retrieval System (MedLARS)
The computerized information retrieval system at the National Library of Medicine.
Medical Subject Headings (MeSH terms)
A thesaurus of official indexing terms used when searching some of the databases of the National Library of Medicine (e.g., MEDLINE, TOXLINE).
Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.
Information for drug and biological products that the FDA determines pose a serious and significant public health concern requiring the distribution of FDA-approved patient medication information that is necessary to patients' safe and effective use of the drug products.
Facts or advice on medicines regarding a specific patient or a group of patients.
Any iatrogenic hazard or incident associated with medications that is an inherent risk when medication therapy is indicated; is created through either omission or commission by the administration of a medicine or medicines during which a patient may be harmed, with effects ranging from mild discomfort to fatality; may be attributable to error (human or system, or both), immunologic response, or idiosyncratic response; is always unexpected or undesirable to the patient and the health professional; and whose outcome may or may not be independent of the preexisting pathology or disease process It includes adverse drug events (ADEs), adverse drug reactions (ADRs), and medication errors.
Medication therapy management
Medication therapy management is a distinct service or group of services that optimizes drug therapy with the intent of improved therapeutic outcomes for individual patients.
Medication tier status
An indication, usually designated by the payer for prescriptions, as to whether a medication is a preferred agent within its class (i.e., first tier), second choice (second tier), third choice (third tier), or not covered. Each “tier” is generally associated with decreasing payment from the payer and increasing patient responsibility for the cost of the drug, with “not covered” (or nonformulary) being entirely the patient's responsibility to pay.
Medication usage patterns
Trends and patterns of drug use. Often influenced by reimbursement decisions and formularies of insurance companies, Medicare and Medicaid, direct-to-consumer advertising, etc.
Medication use evaluation (MUE)
A part of the overall performance improvement program within institutional settings that provides in-depth assessment of the medication use process including prescribing, dispensing, administering, monitoring, and outcome. Multidisciplinary involvement.
See Medical Literature Analysis and Retrieval System.
The FDA Medical Products Reporting Program that monitors clinically significant adverse drug events and problems with medical products. Information is found at http://www.fda.gov/medwatch.
Level of decision making variably described as occurring at the institutional/organizational level or at community/regional levels of health care.
A study design where results of previously conducted similar clinical trials are combined, statistically analyzed, and new data are created for interpretation. Meta-analyses are especially useful when previous studies are inconclusive or controversial. They are also useful where sample size of multiple similar studies are too small to detect a statistically significant difference, but combining them will provide adequate sample size to meet a set power.
Level of health care related decision making, which involves decisions made at the individual professional–patient level of health care.
Middle technical style
A writing style used by professionals addressing professionals in other fields. It tends to be formal and avoids use of the first person (e.g., I, us). Technical jargon is avoided in this writing style.
The most frequently occurring value or category in the set of data. A data set can have more than one mode.
Modified systematic approach
A seven-step approach to answering drug information requests that includes (1) secure demographics of requestor, (2) obtain background information, (3) determine and categorize ultimate question, (4) develop strategy and conduct search, (5) perform evaluation, analysis, and synthesis, (6) formulate and provide response, and (7) conduct follow-up and documentation.
Detrimental consequences (other than death) related to a treatment, exposure, or disease state.
See Medication therapy management.
See Medication use evaluation.
Two or more variables have extremely high correlations (e.g., >0.90) indicating that they are redundant or that they are measuring the same construct.
See Nonsystematic review.
Narrow therapeutic index
Used to describe a drug with small differences in dose or blood concentration that may lead to dose and blood concentration dependent serious therapeutic failures or adverse drug reactions.
National Committee for Quality Assurance (NCQA)
An organization dedicated to assessing and reporting on the quality of managed care plans; it surveys and accredits managed care organizations much like JCAHO accredits hospitals.
National Patient Safety Goals (NPSGs)
Program established and updated by The Joint Commission to assist health care organizations to address safety concerns related to patient safety.
See National Committee for Quality Assurance.
A drug formulary that starts out with every marketed drug product and specifically eliminates products that are considered inferior, unnecessary, unsafe, too expensive, and so forth.
Failure to exercise that degree of care that a person of ordinary prudence or a reasonable person would exercise under the same circumstances. Elements of a negligence case include (1) duty breached, (2) damages, (3) direct causation, and (4) defenses absent.
Occurs when the defendant carelessly makes a representation or statement without reasonable basis to believe it to be true. The burden of proof that is required passes to the person who made the statement who must prove that the statement was either not one of fact but opinion and that he or she had reasonable ground to believe and did believe that the facts represented were true.
Also referred to as a multiple treatment comparison meta-analysis or mixed treatment meta-analysis, it is a network of randomized controlled trials which is developed where all these trials have one intervention in common. This network allows an indirect estimate for comparison of interventions A and B when head-to-head trials do not exist.
New drug application (NDA)
The application to the FDA requesting approval to market a new drug for human use. The NDA contains data supporting the safety and efficacy of the drug for its intended use.
New molecular entity (NME)
A compound that can be patented and has not been previously marketed in the United States in any form.
See Number needed to treat.
A controlled study conducted in a single subject where periods of exposure to a treatment are compared to periods of exposure to a placebo or alternative therapy, such as standard of care, to determine the effects of the treatment on various variables and outcomes in the subject.
Data that are categorical (e.g., yes/no; male/female).
A scale of measurement that places data into mutually exclusive categories without reference to rank order.
Any difference shown in a noninferiority design trial between two treatments is small enough to conclude the test drug has an effect not too much smaller (no worse) than the active control or reference drug.
A prespecified amount of effect used to show the test drug's treatment effect is not worse than the reference drug by more than this specific degree.
Noninherent drug risks
Are created by the particular drug in combination with some extrinsic factor that the pharmacist should reasonably know about.
A basic principle of consequentialist theory which encompasses the duty to do no harm.
Statistical tests used to analyze data that is not normally distributed such as nominal and ordinal data.
Statistical tests that do not assume a conditional normal distribution.
Treatment options focusing on a holistic approach to patient care (e.g., nutrition and exercise-related interventions).
Nonpublic unsolicited requests
A nonpublic unsolicited request is an unsolicited request that is directed privately to a firm using a one-on-one communication approach.
A type of bias called nonresponse bias where the answers of respondents differ from the potential answers of those who did not answer the survey. This is the result of a nonresponse error associated with the survey.
Occurs when a significant number of subjects in a sample do not respond to the survey. The potential result of this is a type of bias called nonresponse bias where the answers of respondents differ from the potential answers of those who did not answer.
A review article that summarizes previously conducted research, but does not provide a description of the systematic methods used to identify the research included in the article. Also called a narrative review.
See National Patient Safety Goals.
The hypothesis that states there is no difference or relationship in the data. Statement of no difference in outcome between the intervention and control; created before the beginning of a study. This statement is either rejected or failed-to-be-rejected (i.e., accepted) at the end of the study based upon the p-value compared to the alpha value.
Number needed to treat
A measure used to determine the effectiveness of an intervention. This measure states the average number of patients who need to be treated with the intervention to prevent one additional negative outcome such as a myocardial infarction. The higher the value, the less effective is the intervention.
See Omnibus Reconciliation Act of 1990.
A study where the investigator analyzes naturally occurring events.
Tendency for observer/investigator to consciously or unconsciously distort what they see and record as the effect in a clinical trial situation. In other words, seeing what they expect to see.
A measure of association between an exposure and an outcome. This ratio represents the chances that an outcome will occur given a particular exposure compared to the chances of the outcome occurring in the absence of that exposure.
Information that originates from sources (e.g., clinical studies, case reports) outside of the FDA-approved prescription drug labeling.
Consulting the correct source, but failure to locate the correct answer(s) when providing information.
Omnibus Reconciliation Act of 1990 (OBRA '90)
A statute (Public Law 101-508) focused on drug benefits provided under Medicaid. The statute requires pharmacists to conduct drug utilization review (DUR) including prescription screening, patient counseling, and documentation of interventions.
A statistical test of an overall difference. That is, the test indicates if at least one difference or relationship is statistically significant.
A hypothesis that makes claim to the direction of the difference or relationship.
The process of connecting to a remote computer via modem or network.
A formulary that allows any marketed drug to be ordered in an institution or under a third-party plan. Can be considered an oxymoron.
See Ordinal scale.
A scale of measurement that has rank order, but makes no reference to the distance between ranks.
See Reasonable care.
A JCAHO initiative to mandate the use of performance measurement tools to monitor outcomes and integrate these data into the accreditation process.
Quality assurance indicators that review whether the final desired result was obtained from whatever action was being reviewed.
A change in a patient's health status (e.g., recovery, death, disability, disease, discomfort, and dissatisfaction) that can be attributed to the care provided.
A systematic investigation which seeks to provide evidence about which interventions are best for certain types of patients and under certain circumstances. An attempt to identify, measure, and evaluate the end results of health care services. It may include not only clinical and economic consequences, but also outcomes, such as patient health status and satisfaction with their health care.
A general term for a summary of the literature. It includes nonsystematic (narrative), systematic (qualitative), and quantitative (meta analyses) reviews. p
The probability of obtaining a test statistic as large or larger than the one actually obtained, conditional on the null hypothesis being true. It is the remaining area under a given probability distribution.
See Pharmacy and therapeutics committee.
Traditional method to compile a meta-analysis by synthesizing the results of different trials to obtain an overall estimate of the treatment effect (one intervention relative to the control). The key is that all trials have the same intervention. All trials used are comparing treatment A to treatment B.
A technique to test reliability of responses to questions in a survey by the responders. The technique usually consists of alternatively worded survey items placed throughout the survey. The parallel concept applies in that a question is asked in a positive manner in one place and in a negative manner in another place of the survey instrument. The answers to these alternate questions undergo a correlation analysis to determine the relatedness of the respondents alternate answers.
A study where two or more groups receive different treatments and the outcomes are compared.
A measurement that describes part of the population.
Failure to consult the correct source in providing information.
Statistical tests used to analyze data with a normal (e.g., bell-shaped) distribution. Commonly used to analyze ratio and interval data.
Statistical tests that assume a conditional normal distribution.
Solutions containing drug products for intravenous administration.
Delivers written or verbal drug information through a planned activity initiated by a health care provider with the goal of changing patient behavior, improve adherence, and ultimately improve health.
Patient pocket formulary
Pocket-sized drug formulary listing top therapeutic drug classes, preferred products within those classes, cost index for the products, and other pertinent information.
Patient Safety Organizations (PSO)
The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) authorized the creation of a nationwide network of Patient Safety Organizations (PSOs) to improve safety and quality through the collection and analysis of data on patient events.
Patient-centered medical home (PCMH)
Team-based healthcare delivery led by a physician or other primary care provider, but including multiple other types of providers, including pharmacists, to optimize patient outcomes.
See Pharmacy benefit management companies.
A quality assurance program that centers on the evaluation of specific individuals by other similar professionals. Also, the process where a group of experts review a manuscript for accuracy and appropriateness for publication in a biomedical journal.
Per protocol analysis
Assessment of the study results in only those subjects completing the entire study duration.
Items used to measure quality as part of the check function of quality improvement. The indicators typically focus on the process or outcomes of a care system, although they can also focus on structure.
A study design technique to analyze the study results of only those subjects who completed the entire duration of the study.
Personal health records (PHRs)
Health 2.0 applications that provide the patient increased opportunity to participate in the collection, maintenance, and sharing of their personal health-related information through a Web-based environment.
A pharmacoeconomic term that describes whose costs (such as the insurer, or the patient) are relevant based on the purpose of the study.
The responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient's quality of life.
The description and analysis of the costs of drug therapy to health care systems and society—it identifies, measures, and compares the costs and consequences of pharmaceutical products and services.
A type of study that combines clinical pharmacology and epidemiology design concepts to study the use of and the effects of drugs in large numbers of people.
The process of preventing and detecting adverse effects from medications.
Pharmacy and therapeutics (P&T) committee
A group in an institution or company that oversees any and/or all aspects of drug therapy for that institution or company. In hospitals, it is usually a subcommittee of the medical staff. May be known by a variety of similar names, such as pharmacy and formulary committee, drug and therapeutics committee (DTC), or formulary committee.
Pharmacy benefit design
Contract that specifies the level of coverage and types of pharmaceutical services available to the health plan member.
Pharmacy benefit management (PBM) companies
Organizations that manage pharmaceutical benefits for managed care organizations, medical providers, or employers.
Focuses on the use of information, information systems, and automation technology to ensure safe and effective medication usage.
Select pharmacies and pharmacy chains where members of a health plan have to go to get their prescriptions filled, usually at a lower cost.
A pharmaceutical preparation that does not contain a pharmacologically active ingredient, but is otherwise identical to the active drug preparation in terms of appearance, taste, and smell.
Placebo creep (also known as biocreep)
The phenomenon that results in the reference drug becoming no better than placebo in noninferiority trials. This occurs when a somewhat inferior test drug is chosen as the reference drug for a future generation of NI trials. After multiple generations of this occurring, the final result is a future reference drug that is no better than placebo.
A phenomenon where the patient has a perceived or actual improvement in their medical condition after receiving placebo treatment.
A specialized area of drug information. By definition, it is the provision of information on the toxic effects of an extensive range of chemicals, as well as, plan and animal exposures.
Poison information center
A place that specializes in research, management, and dissemination of toxicity information. A physician usually directs it, although a pharmacist directs many on a day-to-day basis. Often, pharmacists and nurses provide staffing of these centers.
A broad, general statement that takes into consideration and describes the goals and purposes of a policy and procedure document.
Popular technical style
A writing style used by professionals addressing lay people. This is less formal than writing addressed to professionals.
Every individual in the entire universe with the characteristics or disease states under investigation. Since entire populations are generally very large, a sample representative of the population is usually selected for an investigation.
A drug formulary that starts out with no drug products and specifically adds products, after appropriate evaluation, that are needed by the institution or company. Post hoc
In clinical trial design, this distinguishes something that is done after the study is completed.
Postgraduate year one (PGY1) residency
An organized, directed, accredited program that builds on knowledge, skills, attitudes, and abilities gained from an accredited professional pharmacy degree program. The first-year residency program enhances general competencies in managing medication use systems and supports optimal medication therapy outcomes for patients with a broad range of disease states.
Postgraduate year two (PGY2) residency
An organized, directed, accredited program that builds on the competencies established in postgraduate year one of residency training. The second-year residency program is focused on a specific area of practice. The PGY-2 program increases the resident's depth of knowledge, skills, attitudes, and abilities to raise the resident's level of expertise in medication therapy management and clinical leadership in the area of focus. In those practice areas where board certification exists, graduates are prepared to pursue such certification.
The process of continually monitoring and reviewing suspected adverse reactions associated with medications once they reach the market and are available to the public. Legislation mandates this activity for pharmaceutical manufacturers and the U.S. Food and Drug Administration (FDA), but health care providers can also participate by reporting adverse drug events, adverse drug reactions, and medication errors to the FDA and other regulatory bodies.
Postmarketing surveillance study
A study designed to examine drug use and frequency of side effects following approval by the Food and Drug Administration (FDA).
The ability of a study to detect a difference between a study intervention and control if a difference exists. Usual minimum target value is 80%; power increases by increasing sample size, which also decreases the probability of a Type II or beta error.
A statistical procedure conducted by the investigators to determine a sample size for the trial.
Preferred drug product
Specific drug product within a specific therapeutic class selected as the most appropriate to treat a specific disease or condition as determined by the pharmacy and therapeutics committee.
Preferred therapeutic class
Specific drug class selected as the most appropriate to treat a specific disease or condition as determined by the pharmacy and therapeutics committee.
The ability of a drug to be prescribed for the first time.
Measures the number of people in the population who have the disease at a given time. Prima facie
A fact presumed to be true unless it is disproved. That is, evidence that is sufficient to raise a presumption of fact or to establish the fact in question unless rebutted.
The author listed first on a publication. Sometimes referred to as the first author.
An outcome measured by the study investigators that quantifies the difference in effect between the intervention and control of the clinical trial. The results of this outcome measurement are used to answer the primary study objective. This outcome is also used by the study investigators to determine other study methods (e.g., sample size, statistical tests, duration, dose, patient type to enroll).
Original research published in biomedical journals.
In ethical analysis, a principle is relatively broad and fundamental in scope, and guides ethical decision-making or actions.
Authorization from the health plan or pharmacy benefit manager in conjunction with the pharmacy and therapeutics committee for specified medications or specified quantities of medications. Request is reviewed against preestablished criteria which are based on evidence-based medicine.
A rule within the principle of autonomy, more generally relating to the right of the individual to control his or her own affairs without interference from or knowledge of outside parties.
Probabilistic sensitivity analysis
A sensitivity analysis that allows one to determine how the results of an analysis would change when these best guesses or assumptions are varied over a rel evant range of values. In cost-effectiveness analysis, probability distributions are created for each factor about which there is uncertainty. By simulating the results of random samplings from these distributions, it enables judgments to be formed about the decisions in relation to each factor.
Specific actions to be taken.
Refers to the set of activities that occur between the patient and the provider, encompassing the services and products that are provided to patients and the manner in which the services are provided.
Making a change to routine process. It may be through changes in policy or procedures, implementation of new services, acquisition of new equipment, changes in staffing, generation of regular notifications, or other methods. It is used to correct practice when quality assurance/drug usage evaluation/medication usage evaluation shows a deficiency.
Quality assurance indicators based on the presence or absence of policies and procedures. These assume that if policies and procedures are appropriate they will be effective and be properly performed.
A workflow diagram that provides a clear and consistent understanding of the steps and/or parallel processes required to accomplish a task. This is a process undertaken in many industries as an approach to developing standardized work as part of process improvement. It generally identifies variations within a process that may contribute to excess waste or risk.
The information affixed to the product and used to identify the contents.
Product information including prescribing information.
Rules of conduct or standards by which a particular group in society regulates its actions and sets standards for its members.
Any written communication prepared in the fulfillment of the practice of a profession.
Research focused on the impact and economic value of programs and services provided by pharmacists in community and institutional settings.
A discipline or science that is goal oriented, organized, detailed, and has built-in accountability.
An indicator used in any quality assurance program that determines whether quality is acceptable before an action is taken or care is given.
A study where data are collected forward in time from date of study initiation.
Protected Health Information (PHI)
A term under the HIPAA Privacy Rule which refers to individually identifiable health information that can be linked to a particular person. Specifically, this information can relate to the individual's past, present, or future physical or mental health or condition, the provision of health care to the individual, or past, present, or future payment for the provision of health care to the individual. Common identifiers of health information include names, social security numbers, addresses, and birth dates.
When a treatment for the first symptoms of a disease or other outcome appears to cause the outcome. In this case, the first symptoms of the outcome of interest are the reason for the treatment under study and not the outcome itself. For instance, early symptoms of pancreatic cancer can be the symptoms of diabetes since beta cells are being destroyed by the cancer.
Cause which immediately precedes and produces the effect, as distinguished from the remote or intervening cause.
Public unsolicited requests
An unsolicited request made in a public form, whether directed to a firm specifically or a forum at large.
To selectively pick publications and not include all publications available on the topic for the article.
Pure technical style
A writing style used by professionals addressing other professionals in the same field. It tends to be formal and avoids use of the first person (e.g., I, us). Technical jargon can be used in this writing style.
A method by which information is actively sent to users' computers with little, if any, effort required by the user. The information may be displayed as a screen saver or the computer may in some way let the user know that the information is available to be displayed (e.g., pop up notification).
A statistical value calculated based on the study results. When this number is less than the α-value, it is interpreted as the probability of rejecting a true null hypothesis or the probability of chance being the reason that a difference in the results between the two groups was calculated.
QR (Quick Response)
Codes A type of two-dimensional bar code that provides more information than is possible with a standard UPC barcode. It is increasingly common to find these codes on advertisements or items available for purchase, where the code can be scanned by an application on a smartphone to provide referral to a Web site where further information may be found on something of interest.
Qualitative systematic review
See Meta-analysis or Systematic review.
A degree or grade of excellence that can be applied to goods, services, processes or even people.
Quality assessment and assurance committee
A committee found in long-term care facilities to evaluate quality of care, including drug usage evaluation.
A process used to ensure that something is done or made well enough. It is usually retrospective and focuses only on a particular component within a process, not the entire process.
When this term is used in health care, it is used to indicate methods of quantifying the type of care a patient received (indicators may include details about processes and organization structure, overall patient outcomes, and even patients' perceptions of the quality of the care received).
Quality of life
This is an evaluation of a patient's living situation based on the patient's environment, family life, financial situation, education, and health. It is used in quality assurance programs when developing indicators. In some cases, quality-of-life aspects will take precedence over the absolute best treatment. For example, a quick cure to a disease state may not be as desirable when it costs so much that a family is bankrupted in the process.
Quality-adjusted life years (QALY)
A QALY is a health-utility measure combining quality and quantity of life, as determined by some valuations process.
Quantitative systematic review
See Meta-analysis or Systematic review.
Set quantity of drug that can be prescribed, which is set by the health plan in conjunction with the pharmacy and therapeutics committee and is usually based on FDA-prescribing guidelines.
See Sample error.
A process used in a study in which all subjects enrolled in the study have an equal opportunity to be in any of the study groups. This is used to reduce bias, enable the groups to be as similar as possible at baseline, and is required to validate certain statistical tests.
Randomized clinical trial
See Controlled clinical trial.
The difference between the highest data value and the lowest data value.
Usually measure the proportion of activities, or patients, that conform to a desired standard (e.g., the proportion of stat orders that are dispensed within 15 minutes).
Rank ordered data in which each measurement has a meaningful equal distance between points and also an absolute/natural zero (e.g., temperature in Kelvin).
A scale of measurement that has rank ordered data with meaningful distance between ranks and a natural zero.
Also called due care or ordinary care; conduct that an ordinarily prudent or reasonable person would normally exercise in a particular situation to avoid harm to another, taking the circumstances into account. The concept of due care is used as a test of liability for negligence and usually made on a case-by-case basis where each juror has to determine what a reasonable man or woman would do.
See Inference engine.
In relation to adverse drug reactions, this occurs when the drug is discontinued and, after the adverse drug reactions (ADR) abates, the patient is given the same medication in an attempt to elicit the response again.
An expert in a particular area who reviews a written document to determine whether it is appropriate for publication.
A publication in which the editors have experts in the appropriate field review items submitted for possible publication to determine whether those items are of suitable quality.
Regulatory project manager (RPM)
This is the sponsor's primary FDA contact person. Each application that is submitted is assigned a regulatory project manager (RPM). Contact information for the RPM is provided in the letter sent to the applicant acknowledging receipt of the application. If the RPM is changed during the course of the review, the applicant is notified by the new RPM.
The risk of developing a disease or adverse event in those participants exposed to a specific variable compared to those not exposed to that variable.
See Risk evaluation and mitigation strategy.
(also known as the alternative hypothesis) It is a difference between the therapy under investigation and the control.
The difference between the model predicted dependent variable and the actual dependent variable value. Respondeat superior
Refers to the proposition that the employer is responsible for the negligent acts of its agents or employees.
See Measurement error.
Restatement (Second) of Torts
“An attempt by the American Law Institute to present an orderly statement of the general common law of the United States, including in that term not only the law developed solely by judicial decision, but also the law that has grown from the application by the courts of statutes...” It takes into account other factors, such as the modern trend of the law according to influential jurisdictions and well thought out opinions.
An indicator used in any quality assurance program that determines whether quality was acceptable after an action was taken or care was given.
A study that analyzes historical data (e.g., previously collected data such as medical records or insurance information).
Risk Evaluation and Mitigation Strategy (REMS)
A risk management plan required by the FDA that goes beyond requirements in the drug prescribing information to manage serious risks associated with a drug.
Risk minimization action plans (RiskMAPs)
A strategic safety program designed to meet specific goals and objectives in minimizing known risks of a product while preserving its benefits.
See Risk minimization action plans.
The ability of the statistical test to produce correct test statistics and parameter estimates in the presence of assumption violations.
Root cause analysis (RCA)
In response to a sentinel or serious event, the expectation of The Joint Commission is that the organization will conduct a timely, thorough, and credible analysis to determine root causes of the event, develop and implement an action plan to reduce the risk of recurrence, and monitor the effectiveness of the plan and its implementation.
This acronym has multiple meanings, but is usually defined as Really Simple Syndication. It is a method by which an aggregator program collects information from Web sites and Weblogs (blog), which is then displayed as a collation. This allows individuals to monitor new or additional information on the Internet without having to use a browser to go to multiple Web sites.
In ethical analysis, a rule guides ethical decision making or actions, but is relatively specific in context and restricted in scope.
Computer programs, similar to ADE monitoring systems, with built-in, logic rules designed to aid in monitoring specific aspects of patient care.
A short duration of patient assessment but prior to being enrolling in the study. Various reasons exist for this phase and include assessment of medication compliance, meet an inclusion criteria (e.g., LDL-C less than 130 mg/dL), and allow for medication washout.
A group of subjects, taken from the population, who are enrolled in a study; these individuals should represent the population in order for the study results to be extrapolated to the population.
A term describing the population that will actually be drawn from to make up the sample.
A measure of how close an estimator is expected to be to the true value of a parameter.
The number of subjects in a study.
See sampling error.
In statistics, this is incurred when the statistical characteristics of a population are estimated from a subset or sample of that population. The statistics on that sample such as means and variances differ from the parameters of the entire population because not all members of the entire population are used (also known as sample error).
An outcome measured by the study investigators that quantifies the difference in effect between the intervention and control of the clinical trial, but not considered the focus of the study. The results of this outcome measurement are used to answer secondary study objectives. For example, a study compares a statin to placebo to determine if the statin can reduce the risk of having a stroke (primary endpoint); change in LDL-C levels are also compared between the two groups (secondary endpoint).
Resources that index and/or abstract literature from biomedical journals.
Study subjects who meet the study inclusion/exclusion criteria but are not randomized into either the intervention or control (i.e., excluded from the study).
An error in selection method to obtain individuals or groups to take part in a scientific study.
See Standard error of the mean.
The probability that a diseased individual will have a positive test result. It is the true positive rate of the test. The ability of a test to correctly identify those with the disease.
Tests that are undertaken to determine the influence of various criteria or conditions on study results. Sensitivity analyses are commonly used in meta-analyses and pharmacoeconomic research.
The Joint Commission defines a sentinel event as an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase “or the risk thereof” includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called sentinel because they signal the need for immediate investigation and response.
Reflect the occurrence of a serious event that requires further investigation (e.g., adverse drug-related event, death).
The measure of symmetry of a curve.
A cellular device that has Internet capabilities and supports various software functions.
Form of electronic communication allowing interactions with users to share information, messages, and other various forms of content.
Software as a service (SaaS)
(also known as application service provider [ASP]) A computing model in which an organization's data and software are hosted by an off-site vendor who is responsible for maintaining data storage as well as the equipment on which it is stored.
Special Protocol Assessment
Is a statement from the U.S. Food and Drug Administration that an uninitiated or ongoing Phase III trial's design, clinical endpoints, and statistical analyses are adequate for FDA approval.
The probability an individual without a disease will have a negative test result.
An organization (or individual) that takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, government agency, academic institution, private organization, or other organization.
An individual who both initiates and conducts a clinical investigation (i.e., submits the IND and directly supervises administration of the drug as well as other investigator responsibilities).
A study designed to determine the stability of drugs in various preparations.
Any individual who affects or is affected by the problem or issue addressed by the policy.
A term used in quality assurance program that indicates how often an indicator must be complied with. The level of compliance will be set at either 0% (i.e., never done) or 100% (i.e., always done). A threshold, which allows compliance of between 0% and 100%, has sometimes been used instead of a standard.
(1) A measurement of the range of data values (i.e., variability) around the mean. (2) The measure of the average amount by which each observation in a series of data points differs from the mean. In other words, how far away is each data point from the mean (dispersion or variability) or the average deviation from the mean.
Standard error of the mean (SEM)
An estimate of the true mean of the population from the mean of the sample. Mathematically, SEM is calculated as the standard deviation divided by the square root of the sample size. Ninety-five percent of the time, true mean of the population lies within +2 standard errors of the sample mean. Describes the precision of the mean of a sample of data that is being used to estimate some unknown or “true” value of the mean of the target population. The standard error of the mean (SEM) increases as the variability of the data increases, and decreases as the sample size increases.
One method used in measuring health preferences. Each subject is offered two alternatives. Alternative one is treatment with two possible outcomes: either the return to normal health or immediate death. Alternative two is the certain outcome of a chronic disease state for life. The probability of dying is varied until the subject is indifferent between alternative one and alternative two. Used to assess his or her quality-adjusted life years (QALY) estimate.
A measurement that describes part of a sample.
The impact of a study in terms of the outcome of statistical tests conducted on the data. A study is said to be statistically significant when statistical tests demonstrate a difference between treatment groups.
Written law enacted by a legislature other than that of a municipality.
Prescribing guidelines set by the health plan in conjunction with the pharmacy and therapeutics committee that specify which drugs should be prescribed first before more expensive drugs will be covered. Guidelines are based on evidence-based medicine.
An advanced type of randomization to produce study groups as similar as possible; considers baseline demographic information of the subjects selected for the study.
Also called absolute liability; the legal responsibility for damages, or injury, even if the person was not at fault or negligent. Strict liability has been applied to certain activities, such as holding employers absolutely liable for the torts of their employees, but it is most commonly associated with claims for injuries resulting from defectively manufactured or designed products. A successful plaintiff need only show that the product was in fact defective in design or manufacture, rendering it unreasonably dangerous and the cause of injury.
Refers to the characteristics of providers, the tools and resources at their disposal, and the physical or organizational settings in which they work.
Quality assurance indicators based on the presence or absence of items, such as staffing patterns, available space, equipment, resources, or administrative organization.
A brief statement of the goals and purpose of a research study.
Evaluation of study results within a subset of subjects enrolled in the study according to specific demographic (e.g., age, gender, disease state).
An individual who participates in a clinical investigation (either as the recipient of the investigational drug or as a member of the control group).
A party moving (applying) for summary judgment is attempting to avoid the time and expense of a trial when the outcome is obvious. A party may also move for summary judgment in order to eliminate the risk of losing at trial, and possibly avoid having to go through discovery (i.e., by moving at the outset of discovery), by demonstrating to the judge, via sworn statements and documentary evidence, that there are no material factual issues remaining to be tried. If there is nothing for the fact finder to decide, then the moving party asks rhetorically, why have a trial? A dispute over a material fact on which the outcome of a legal case may rely, and which, therefore, must be decided by a judge or jury; a dispute which precludes summary judgment.
A study measurement (e.g., laboratory value or physical assessment) that serves as a substitute marker for an actual clinical outcome. It is an effect that can be easily measured to correlate an outcome that is more difficult and/or time-consuming to measure (e.g., lowering LDL-C levels [measured effect] should result in reducing cardiovascular events [predicted outcome] such as myocardial infarction, stroke, or death).
Research where responses to questions asked of subjects are analyzed to determine the incidence, distribution, and relationships of sociological and psychological variables.
The ability to exchange one drug for another.
A meeting focused on a particular topic.
Synthesis is the careful, systematic, and orderly process of integrating varied and diverse elements, ideas, or factors into a coherent response. This process relies not only on the type and quality of the data gathered, but also on how the data are organized, viewed, and evaluated. Synthesis, as it relates to pharmacotherapy, involves the careful integration of critical information about the patient, disease, and medication along with pertinent background information to arrive at a judgment or conclusion.
A summary of previously conducted studies where the research to be included in the review is systematically identified; however, the results are not statistically combined as would occur with a quantitative systematic review or meta-analysis. Also called a qualitative systematic review.
Target drug program
A program that evaluates the use of a medication or group of medications on an ongoing basis. Within these programs, interventions are usually made at the time of discovery based on established criteria or guidelines.
The entire group a researcher is interested in because this is the population that the findings of the survey are meant to generalize and the researcher wishes to make inferences and draw conclusions.
It is defined as the use of telecommunications and interactive video technology to provide health care services to patients who are at a distance.
A program for microcomputers that causes the computer to mimic a dumb terminal, so that it can run programs on other computers (usually minicomputers or mainframes) over the Internet or other computer networks.
Ten major considerations
A tool containing 10 items identified to evaluate a clinical trial article that if any single item is considered a limitation, the reliability of the entire article is questionable and the results deemed possibly unreliable.
Toxicity of drugs to the unborn fetus.
Textbooks and drug compendia (includes full-text computer databases) that consists of established knowledge.
The Joint Commission (TJC)
Organization that accredits health care organizations and programs in the United States.
Organization that pays for or underwrites coverage for health care expenses for another entity.
A method of reimbursement for medical care in which neither the care provider nor the patient is charged. Third-party payers include insurance, health maintenance organizations, and government entities.
A term used in quality assurance program that indicates how often an indicator must be complied with. Unlike standards, thresholds can be set at any level of compliance from 0% to 100%.
Tiered copayment benefit
A pharmacy benefit design that encourages patients to use generic and formulary drugs, by requiring the patient to pay progressively higher copayments for brand name and nonformulary drugs.
A method for measuring health preferences. The subject is offered two alternatives. Alternative one is a certain disease state for a specific length of time t, the life expectancy for a person with the disease, then death. Alternative two is being healthy for time x, which is less than t. Time x is varied until the respondent is indifferent between the two alternatives. The proportion of the number of years of life a person is willing to give up (t - x) to have his or her remaining years (x) of life in a healthy state is used to assess his or her quality-adjusted life years (QALY) estimate.
See The Joint Commission.
Civil wrongs recognized by law as grounds for a lawsuit.
Total quality management (TQM)
A management concept dealing with the implementation of continuous quality improvement.
See Total quality management.
A mean difference in the outcome measure over time between two drugs (i.e., drug minus placebo or test drug minus reference drug)
Treatment order effect
A situation where the order in which patients receive the treatment in a trial (generally a crossover design) affects the results of that trial.
See Case-control study.
A study where researchers apply a treatment and determine its effects on subjects.
Individuals without the disease who were correctly identified as being disease free by the test.
Individuals with the disease who were correctly identified as diseased by the test.
A hypothesis that does not claim a direction of the difference or relationship.
Type I error
The probability of a false positive result. The probability of a type I error is equal to alpha and occurs when the null hypothesis is rejected when it is in fact true. Falsely rejecting the null hypothesis when, in fact, the null hypothesis is true.
Type II error
The probability of a false negative result. The probability of a type II error is equal to beta and occurs when the null hypothesis is accepted when it is in fact false. Failing to reject the null hypothesis when, in fact, the null hypothesis is false.
Unexpected drug reaction
The Food and Drug Administration defines this as “one that is not listed in the current labeling for the drug as having been reported or associated with the use of the drug. This includes an ADR that may be symptomatically or pathophysiologically related to an ADR listed in the labeling but may differ from the labeled ADR because of greater severity or specificity (e.g., abnormal liver function versus hepatic necrosis).”
Uniform resource locator—URL
An Internet address (e.g., http://druginfo.creighton.edu).
Requests initiated by persons or entities that are completely independent of the relevant firm.
A large number of discussion groups that are replicated in numerous places on the Internet. Users can read items posted on a topic and can contribute their own items to be posted.
The truthfulness of study results. Internal validity refers to the extent to which the study results reflect what actually happened in the study (i.e., appropriate and sound study methods). External validity is the degree to which the study results can be applied to patients routinely encountered in clinical practice.
A type of term or limit used to narrow a search to only the highest quality studies, such randomized controlled trial or double-blind.
See External validity.
See Internal validity.
Has been assigned many definitions, but within health care, it usually reflects the ratio of quality and costs (value = quality/cost).
Factors (characteristics that are being observed or measured) that are the focus of a study. The independent variable (e.g., treatment) causes change in the dependent variable (e.g., outcome).
A measurement of the range of data values (i.e., variability) about the mean. Variance is the square of the standard deviation.
This term addresses the obligation to truth telling or honesty.
Also called imputed liability or imputed negligence; the doctrine that attaches responsibility on one person for the failure of another, with whom the person has a special relationship (such as parent and child, employer and employee, husband and wife, or owner of vehicle and driver), to exercise such care as a reasonably prudent person would use under similar circumstances. Ordinarily, the independent negligence of one person is not imputable to another person.
Virtual private network (VPN)
A method to connect computers over a distance, for example, over the Internet, which allows secure transmission of confidential data.
An assurance by one party to a contract of the existence of a fact upon which the other party may rely, intended to relieve the promisee of any duty to ascertain the fact for himself or herself. Amounts to a promise to indemnify the promisee for any loss if the fact warranted proves untrue. Warranties may be express (made overtly) or implied (by implication).
Simply refers to those applications of the Internet that are interactive and social, allowing for collaboration and interactivity among patients, caregivers, and providers. Web 2.0 is not new software but a different strategy to use the Web. The Web goes beyond being a search engine and a source of information to include a platform to create, share, and collaborate in developing new knowledge. Social networking is the phenomenon of online communities in which people share interests and/or activities with one another and is an outgrowth of Web 2.0.
A computer program used to access information on the World Wide Web. The most popular programs are Microsoft Internet Explorer, Google Chrome, and Mozilla Firefox.
A Web site that acts as an interface to the Internet for users. Many Internet search engines are considered to be Web portals. A variation on this, the enterprise portal, can also be used by an institution to help guide employees to necessary information within the institution or out on the Internet.
(also known as blog) This is a public Web site where a person maintains a journal that is open to viewers.
A group of Web pages that will provide information to the person requesting that information. These pages are generally grouped under one main Internet address (URL).
Wide area network (WAN)
A group of computers connected in a way that they may share data, programs, and/or equipment over a distance (e.g., connection between computers owned by an institution that are scattered in clinics around a city).
Web sites which allows its users to add, modify, or delete its content via a Web browser usually using a simplified markup language or a rich-text editor. Wikis are powered by wiki software, are created collaboratively, and can be community Web sites and intranets, for example. Some permit control over different functions (levels of access). For example, editing rights may permit changing, adding, or removing material. Others may permit access without enforcing access control.
World Wide Web (WWW)
Computers connected to the Internet that provide a graphical interface to a variety of information that is available as text, pictures, sounds, databases, and other electronic files. Generally accessed using a Web browser, such as Internet Explorer.
A combination of HTML and Extensible Markup Language.
XML—Extensible Markup Language
A superset of HTML that provides information on the content of a Web page, presentation of the information (how it looks), and semantics (what it means). This is designed to make it easier to find more relevant information using search engines. z
The distance a data point is from its variable's mean in standard deviation units.