INTRO TO RESEARCH METHODS AND STATISTICS - LEARNING OUTCOMES Flashcards

1
Q

Describe how you would go about defining a research questions for further study.

A

Whatever form a research question takes, it needs to be well-defined. One useful way of focussing a research question is to use the PICO approach:

People, patients or population – who are you asking the question about?

Intervention – what intervention are you interested in?

Control or comparison – what are you comparing the intervention to?

Outcome – what outcome are you interested in measuring?

This is mainly applicable to quantitative research questions.

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2
Q

Describe ways of defining disease for a research study.

A

For clinical medicine a patient tends to either be categorised as sick or healthy.

The ways in which individual diseases are defined and diagnosed tend to fit into the clinical, statistical, prognostic and operational categories.

Clinical disease definition is based on the recognition of a characteristic pattern of history, current symptoms and physical signs on examination, often supplemented by data from clinical investigation.

The statistical method of defining disease is in terms of a particular attribute or objective measurement value that lies outside of a defined normal range. This is the standard practice in the definition of abnormal results in many laboratory investigations in which 5% or the population are arbitrarily defined as abnormal.

A prognostic definition involves defining a disease in terms of a measurement, clinical finding, laboratory test result or other characteristic that carries prognostic significance.

Operational definitions of disease are based on the identification of individuals in whom a different management or treatment policy is indicated – for example hypertension is now defined operationally as the level above which therapy is given.

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3
Q

Give a clinical definition of disease.

A

Clinical disease definition is based on the recognition of a characteristic pattern of history, current symptoms and physical signs on examination, often supplemented by data from clinical investigation.

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4
Q

Give a statistical definition of disease.

A

The statistical method of defining disease is in terms of a particular attribute or objective measurement value that lies outside of a defined normal range. This is the standard practice in the definition of abnormal results in many laboratory investigations in which 5% or the population are arbitrarily defined as abnormal.

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5
Q

Give a prognostic definition of disease.

A

A prognostic definition involves defining a disease in terms of a measurement, clinical finding, laboratory test result or other characteristic that carries prognostic significance.

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6
Q

Give an operation definition of disease.

A

Operational definitions of disease are based on the identification of individuals in whom a different management or treatment policy is indicated – for example hypertension is now defined operationally as the level above which therapy is given.

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7
Q

Define Prevalence.

A

Prevalence – the prevalence of a disease is the number of people in a population with disease at any given time, divided by the total number of people in the population. It is a cross-sectional snapshot of disease in a population.

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8
Q

Describe Incidence.

A

Incidence – the incidence of a disease is the number of people who develop disease over a period of time.

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9
Q

Outline the different types of study design.

A
  1. Cross-sectional studies – a study of a population at a specific point in time, used to measure prevalence, and cross-sectional associations between disease prevalence and ‘exposure’.
  2. Case-control studies - the characteristics of people with disease (cases) are compared with people without disease (controls). For example: a case control study for lung cancers would compare cases (individuals with lung cancer) with controls (individuals without lung cancer).
  3. Follow-up (longitudinal or cohort) studies – these involve following up a defined population over a period of time, and can measure incidence and look prospectively at the association between exposure and onset of disease.
  4. Intervention studies or randomised controlled trials – where some people receive a treatment or preventative measure, and others don’t or get a placebo or different treatment. Clinical trials of new drugs in medicine are an example of this.
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10
Q

Outline a cross-sectional study.

A

Cross-sectional studies – a study of a population at a specific point in time, used to measure prevalence, and cross-sectional associations between disease prevalence and ‘exposure’.

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11
Q

Outline a case-control study.

A

Case-control studies - the characteristics of people with disease (cases) are compared with people without disease (controls). For example: a case control study for lung cancers would compare cases (individuals with lung cancer) with controls (individuals without lung cancer).

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12
Q

Outline a cohort study.

A

Follow-up (longitudinal or cohort) studies – these involve following up a defined population over a period of time, and can measure incidence and look prospectively at the association between exposure and onset of disease.

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13
Q

What is meant by the term ‘target population’?

A

Group we want to know about.

The population in which the results of the study are intended to apply

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14
Q

What is meant by the term ‘sample population’?

A

Group we choose to sample from.

The population in which the study is conducted

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15
Q

What is meant by the term ‘participant population’?

A

Those that actually contribute to the study.

The people who take part in the study are referred to as the participants

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16
Q

Why is ethical approval required for research?

A

In order for research to result in benefit and minimise harm ethical approval is important.

17
Q

List some situations in the NHS for which ethical approval would be required.

A

Ethical approval is necessary in the following situations involving the NHS:

  • Working with data from recently deceased patients
  • Accessing data, organs, or other bodily material of past and present NHS patients
  • Research involving foetal material
  • IVF involving NHS patients
  • To carry out research that involves the use of / access to NHS premises or facilities
  • To carry out research involving NHS staff
  • To carry out trials on health volunteers in the NHS where a drug or device is being tested
18
Q

List some situations outside of the NHS for which ethical approval would be required.

A

There are a number of cases for which you would require ethical approval whether or not they take place within the NHS:

  • Adults lacking capacity to consent for themselves
  • Exposure to ionising radiation
  • Human tissue
  • Investigational medical devices
  • Investigational medicinal products
  • Practising midwives
  • Processing confidential patient information without consent
19
Q

Define the difference between research, audits and service evaluations.

A
  • Research derives new knowledge, addresses clearly defined questions and aims, usually involves collecting data and requires ethical approval.
  • Clinical audit assesses the level of service being provided. It measures against a standard. Clinical audits usually involve analysis of existing data but may include interviews and questionnaires. It does not require ethical approval.
  • Service evaluation judges current care. It measures current service without reference to a standard. It usually involves analysis of existing data but may include interviews and questionnaires. Service evaluation does not require ethical approval.
20
Q

Define ‘research’.

A
  • Research derives new knowledge, addresses clearly defined questions and aims, usually involves collecting data and requires ethical approval.
21
Q

Define ‘clinical audit’.

A
  • Clinical audit assesses the level of service being provided. It measures against a standard. Clinical audits usually involve analysis of existing data but may include interviews and questionnaires. It does not require ethical approval.
22
Q

Define ‘service evaluation’.

A
  • Service evaluation judges current care. It measures current service without reference to a standard. It usually involves analysis of existing data but may include interviews and questionnaires. Service evaluation does not require ethical approval.
23
Q

What is the Declaration of Helsinki and what does it mean for research using humans?

A

The declaration of Helsinki was developed by the world medical association as a set of ethical principles for the medical community regarding human experimentation. It was first developed in 1964 and has since been amended 6 times. It is the definitive document on medical research. 2008 is the current version. It contains 35 principles in a 5-page document. The main focus of the declaration of Helsinki is the responsibility of researchers for the protection of research subjects.

  1. Research should be based on knowledge of the scientific background, assessment of the risk and benefits, have reasonable likelihood of benefit to the population studied and be conducted by suitably trained investigators using approved protocols, subject to independent ethical review.
  2. Studies should be discontinued if the available information indicates that the original considerations are no longer satisfied.
  3. Experimental investigations should always be compared against the best methods, but under certain circumstances a placebo or no treatment group may be utilised.
  4. The interests of the subject after the study is completed should be part of the overall ethical assessment, including assuring access to best proven care.
24
Q

What is the Human Tissue Act and what are the principles underlying it?

A

The HTA 2004 was developed to regulate the removal, storage, use and disposal of human tissue. Consent is the fundamental principle of the legislation and underpins the lawful removal, storage and use of body parts and tissue. Different consent requirements apply when dealing with tissue from the diseased and the living.

  1. The Human Tissue Act 2004 regulates the removal, storage and use of human tissue. This is defined as material that has come from a human body and consists of, or includes, human cells.
  2. The Human Tissue Act 2004 creates a new offence of DNA ‘theft’. It is unlawful to have human tissue with the intention of its DNA being analysed, without the consent of the person from whom the tissue came.
  3. The Human Tissue Act 2004 makes it lawful to take minimum steps to preserve the organs of a deceased person for use in transplantation while steps are taken to determine the wishes of the deceased, or, in the absence of their known wishes, obtaining consent from someone in a qualifying relationship. - See more at: https://www.hta.gov.uk/human-tissue-act-2004#sthash.4XLSeqL8.dpuf
25
Q

What are qualitative methods?

A
  • complex psychological, social or cultural issues

- interviews, discussion groups

26
Q

What are quantitative methods?

A
  • highly standardised data collection

- structured