Glossary

Passive surveillance is the use of local healthcare services to collect data on disease incidence or adverse effects of medicines. It relies on staff and services, who are part of a reporting network, collecting data and generating reports. There is no active search for cases.

For example, passive surveillance is the most common method used to monitor the incidence of vaccine-preventable diseases so that national and international bodies can identify possible outbreaks and organise vaccine provisions.

A bacterium, virus, or other micro-organism that can cause disease.

Patient Information Leaflet

A patient registry is a collection of information about individuals, usually those with a specific diagnosis or with specific risk factors for a disease. Some patient registries seek people with varying health levels who may be willing to take part in research about a particular disease. Registries can be funded and/or managed by government agencies, non-profit organisations, clinics, or commercial organisations.

Patient registries have multiple uses. For example, registries for rare diseases can be used to establish the basic characteristics of the disease, how it is managed in clinics, and what outcomes people experience. Other uses include helping to measure clinical effectiveness of treatments in 'real world' settings, and investigating quality of patient care.

Clinical trial registries collect basic health information from people who agree to be contacted about taking part in future clinical trials. Volunteering for a registry does not mean a person has signed up for a clinical trial. Volunteering for a disease registry can sometimes become a first step toward taking part in a clinical trial, but registries and specific trials are not directly linked.

Patient selection can refer to how patients are matched with proposed treatments (in the clinic), or how patients are selected to take part in clinical trials.

For clinical trials, detailed inclusion and exclusion criteria are documented before recruitment of patients can begin. The inclusion and exclusion criteria are an important part of a trial protocol. If they are properly defined, inclusion and exclusion criteria will increase the chances of a trial producing reliable results. They also protect participants from harm and help avoid exploitation of vulnerable people (such as those without the ability to provide informed consent).

The patient year (or person year) statistic is used in many clinical studies and statistical assessments of risk.

Patient years are calculated as follows: If 15 patients participated in a study on heart attacks for 20 years, the study would have involved 300 patient years (15 x 20). This number can be divided by the number of patients who have been affected by a certain condition or event. For example, if six of the patients had heart attacks, that would be equal to one heart attack for every 50 patient years in the study (300 / 6 = 50).

Looking at data in this way can reveal trends and allows researchers to communicate levels of risk. Many studies on new medicines express their findings using patient years. For example, if one serious side effect is experienced for every 1,000 patient years of a study, this might be considered an acceptable level of risk.

A patient-reported outcome (PRO) is a measure of the experience or view of a participant in a clinical study. It is not a clinical measure, or an assessment made by anyone else involved in the study. PROs are commonly collected by asking patients to fill in questionnaires, or by interviewing patients. Questionnaires or interview guides used as part of clinical studies should undergo extensive testing to ensure they are reliable and valid.

PROs can be used to assess, for example, symptoms as experienced by the patient, disability, quality of life, and other health perceptions.

There are many published PRO questionnaires dealing with aspects of quality of life. some have been developed for specific conditions or treatments. Some are designed to be general, such as the 'EuroQoL' or 'EQ-5D', which has been translated into many languages and used extensively in clinical trials.

PRO is often used interchangeably with the term patient-reported outcome measure (PROM).

Patient Reported Outcomes (PROs) are data reported directly by a patient on his or her own health condition, without interpretation by a doctor or anyone else. They are based on a patient™s perception of a disease and its treatment. The findings or outcomes can be measured in absolute terms (e.g. severity of a symptom, sign, or state of a disease or condition) or as a change from a previous measure.

Patient-reported outcome measures (PROMs) are the tools used to measure and collect data on PROs. Generally, findings are measured by a well-defined and reliable patient-reported outcome (PRO) instrument. The use of a PRO instrument is advised when measuring an aspect of the disease or condition that is best known by the patient or is best measured from the patient perspective.

Patients’ and Consumers’ Working Party (PCWP) http://www.ema.europa.eu/ema/index.jsp?curl=pages/partners_and_networks/general/general_content_000708.jsp&mid=WC0b01ac0580028d32"

German National Competent Authority. http://www.pei.de/"