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UNIT B ELEMENT 2

JANUARY 2006 Question No 1 (b) Outline factors that may affect the reliability of these epidemiological methods (4) Recognizing that reliability may be affected by factors such as; the cohort size; the accuracy of historical data on exposure; long latency periods for the effect; the frequency of disease in unexposed cohort; lifestyle factors such as alcohol consumption, diet, smoking etc.; there may be selection bias (cohort may not be representative of exposed population); the healthy worker effect (sick people leave); and the difficulty in following all of cohort for instance a geographic move, non-co-operation etc. (a) Compare and contrast the following epidemiological methods: (i) Retrospective Cohort Study and (ii) Prospective Cohort Study (3) (3)

In answering this question many candidates showed confusion in their understanding of the meaning of retrospective and prospective studies. Compare and contrast was not reflected in most answers. Both methods involve looking for a link between cause (exposure) and effect (disease); using two cohorts in order to compare those that have been exposed against those that were unexposed and looking for a dose/response link. In contrast a retrospective cohort study starts at a point in the past and follows cohort forward in order to determine past exposure histories and health outcomes from records; a prospective cohort study starts at the present time and follows cohort forward and enables monitoring of the exposure and health outcomes.

Prospective vs. retrospective studies


Prospective
A prospective study watches for outcomes, such as the development of a disease, during the study period and relates this to other factors such as suspected risk or protection factor(s). The study usually involves taking a cohort of subjects and watching them over a long period. The outcome of interest should be common; otherwise, the number of outcomes observed will be too small to be statistically meaningful (indistinguishable from those that may have arisen by chance). All efforts should be made to avoid sources of bias such as the loss of individuals to follow up during the study. Prospective studies usually have fewer potential sources of bias and confounding than retrospective studies. Retrospective A retrospective study looks backwards and examines exposures to suspected risk or protection factors in relation to an outcome that is established at the start of the study. Many valuable casecontrol studies, such as Lane and Claypon's 1926 investigation of risk factors for breast cancer, were retrospective investigations. Most sources of error due to confounding and bias are more common in retrospective studies than in prospective studies. For this reason, retrospective investigations are often criticised. If the outcome of interest is uncommon, however, the size of prospective investigation required to estimate relative risk is often too large to be feasible. In retrospective studies the odds ratio provides an estimate of relative risk. You should take special care to avoid sources of bias and confounding in retrospective studies.

(b) Outline factors that may affect the reliability of these epidemiological methods. (4) Recognising that reliability may be affected by factors such as; the cohort size; the accuracy of historical data on exposure and health effects; the accuracy of diagnosis; there may be non-occupational exposure; long latency periods for the effect; the frequency of disease in unexposed cohort; lifestyle fractors such as alcohol consumption, diet, smoking etc; there may be selection bias (cohort may not be representative of exposed population); the healthy worker effect (sick people leave); and the difficulty in following all of cohort for instance a geographic move, non-co-operation etc.

January 2010 Question No 7 (a) Outline the principles of a prospective cohort study as used in epidemiology. (4) A prospective cohort study starts with a hypothesis to be tested. It involves looking for a link between cause (exposure) and effect (disease), using two cohorts in order to compare those that have been exposed against those that were unexposed looking for a dose/response link. The study starts at the present time and follows the cohorts forward enabling the monitoring of exposure and health outcomes. (b) National public health monitoring has recorded several hundred cases of an illness. Inn at least half the cases the cause has been confirmed, by laboratory tests, as a new strain of virus. Outline the possible data AND data sources that could be used for prospective cohort study of this outbreak. (10)

The possible data sources that could be used in the scenario described include: the gender, age, occupation and employment records of those affected and the geographical region involved; exposure data which might reveal the existence of any pattern and pre-existing medical records from GP surgeries; Vaccination history since some may not display symptoms although exposed to the virus; clinical results by testing; morbidity rates; the cause of death to those who succumbed to the illness; the reports of interviews with confirmed cases and with whom they have been in contact; hospital admissions with specific symptoms and laboratory reports of confirmed cases sent to the HPA. (c) Outline factors that may affect the reliability of such cohort studies (6) The cohort size; the accuracy of historical data on exposure and health effects; the accuracy of diagnosis; the reliability of recall from interviewees; there may be non-occupational exposure; long latency periods for the

effect; the frequency of disease in the unexposed cohort; lifestyle factors such as alcohol consumption, diet, smoking etc.; there may be selection bias and the cohort may not be representative of the exposed population; and the difficulty in following up all members of the cohort for instance some may be involved in a geographic move while others decide to take no further part in the project.

January 2011 Question 3 (a) Outline the following toxicological term; (i) (ii) LD 50 LC 50 (2) (2)

LD 50 relates to a single oral or dermal dose sufficient to kill 50 percent of a test population. LD 50 is measured in terms of milligrams (or grams) per kilogram body weight. LD 50 on the other hand, is an inhaled concentration sufficient to kill 50 per cent of a test population in a fixed period of time and is measured in milligrams per litre of air. (b) (i) Outline the toxicity test known as the fixed dose procedure (4) (ii) Outline the possible reasons why the fixed dose procedure has replaced previous methods that estimated LD 50 The toxicity test known as the fixed dose procedure is used to determine acute or oral toxicity with a rat normally being used as the test animal. An initial study is carried to determine the starting dose for the main study and this uses single animals and a successively increased dose to determine the range of toxic effects. The initial test dose for the main study is chosen as the dose which can identify toxicity without mortality. In the main study, an animal is tested at one of four fixed does namely 5, 50,

600 and 2000 mg/kg, with observation being carried out over fourteen days. The discriminating dose (i.e. that causes evident toxicity but not mortality) is determined and is used as the basis for classification such as very toxic, toxic or harmful or equivalent GHS classification. Possible reasons for substituting the fixed dose procedure for previous methods that estimated LD 50 include the fact that a smaller number of animals is used; it uses morbidity rather than mortality as the end point.

Jan 2007 Question Number 7 (a) Explain why it is difficult to determine whether cancers in working population are caused by exposure to substances used at work.

(6)

The difficulties to determine whether cancers in working population are caused by exposure to substances used to work are: the long latency period of many cancers, with changes in the exposure pattern and exposed population during that period; the multi-causality of many cancers and the potential for synergism and interaction with non-occupational causes; the prevalence of common cancers, such as lung cancer, in the general population; individual susceptibility, and poor historical records particularly of past exposure. (b) Review the merits and limitations of each of the following methods for identifying the carcinogenic potential of a substance. (i) Human epidemiology (ii) Animal Studies (ii) In vitro mutagenicity testing (5) (5) (4)

In their review of the merits and limitations of methods for identifying the carcinogenic potential of a substance, candidates could have pointed out that human epidemiology, whilst being a definitive method for identifying human

carcinogens is expensive and time consuming and usually requires large populations. It is not a method to be deployed for assessing the carcinogenic potential of new substances and suffers from problems of sensitivity, specificity, and reliance on accurate records for assessing substances currently in use. Animal testing studies are the best experimental method through the, too, can be expensive and time consuming but the data can be gathered more quickly than by epidemiology. Apart from any ethical concerns, there are difficulties in extrapolating animal data to humans and often very large doses are required to produce a response which may in any case vary with different species. In-vitro mutagenicity testing such as the Ames Test is rapid, low cost and avoids ethical problems. However, whilst a finding of mutagenic potential may well also indicate carcinogenic potential, the tests are not totally reliable and they can produce both false positives and false negatives.