Unit 2 Flashcards

1
Q

Name the factors that can create false impressions of the placebo effect.

A

Spontaneous Improvement, Fluctuation of Symptoms, Additional Treatment, Conditional Switching of Treatment, Scaling Bias, Irrelevant or Questionable Response Variables, Experimental Subordination, Conditioned Answers, Psychotic Misjudgment, No placebo given, Uncritical reporting, misquotation, false assumptions

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2
Q

What are four questions to ask for evaluating CAM therapies?

A

Does the therapy have a beneficial effect on any individual disease or disorder?

Does the therapy have any advantage over existing therapies in terms of efficacy, safety, patient preference, cost, and availability?

Is the effect of the therapy a placebo, or is there some specific treatment effect?

What mechanisms underlie the therapy’s action?

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3
Q

Why is it difficult from a scientific perspective to determine the effectiveness of CAM therapies?

A

The confusing nature of evidence

little medical research

no independent trials

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4
Q

What is the basis of CAM therapies frequently found upon?

A

Claims of those often involved in the CAM therapy (biased)

impossible rationals

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5
Q

How can one establish a scientific basis of therapy for CAM? Give an example

A

show that the therapy is effective in a controlled trial and, if possible, that symptoms relate to an objective measure.

An example: if a disorder is caused by hypoglycemia or a yeast infection, then the symptoms should be there when blood sugar is low or when yeast level is high, and the symptoms should disappear when the objective measure is normalized.

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6
Q

What are the two methods to investigate CAM therapies?

A

Descriptive observation of the therapy and Randomized controlled clinical trials

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7
Q

What is observational research?

A

An investigator using observational research methodology looks for clues to gain insight into a situation or phenomenon.

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8
Q

How is observational research data collected?

A

The investigator collects data through observation. At its simplest level the study may involve a mere one case. This is called a case report. Observation of more than one subject is a case series.

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9
Q

How is observational studies conducted?

A

Subjects can be studied through interviews and surveys.

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10
Q

How are observational study participants selected?

A

Subjects are selected according to their experience with the phenomenon being explored (known as a convenience sample), but they cannot be considered typical or representative of the whole population.

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11
Q

How can good reliability of the observational study be provided through selection of participants?

A

If the group of subjects studied is representative of the target population, obtained in a random fashion, then the results may have reasonably good reliability.

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12
Q

What are the pitfalls of observational studies?

A

bias from practitioner being involved in the therapy for a number of years

Distortion from a single experience due to anecdotal evidence

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13
Q

What are seven factors to consider when examining anecdotal information or case reports?

A
Natural history of disease
Fluctuations in disease
Premature follow-up
Spontaneous regression
Misinterpretation of information
Wrong information
Simultaneous conventional therapy
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14
Q

What is observational research useful for?

A

exploring the nature of a particular condition or phenomenon

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15
Q

What is a placebo?

A

any therapeutic procedure that has an effect on a patient, symptom, or disease without any specific activity for the condition being treated

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16
Q

Why is the placebo effect important when evaluating CAM treatments? Give an example

A

as practitioners typically interact with their clients in ways that are likely to boost the placebo effect. For example, when a practitioner assures a client who has pain from arthritis that he will gain much relief from the treatment, then there is an excellent chance that the patient will indeed feel some relief, even if the treatment has no actual direct impact on the problem.

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17
Q

What are some of the myths of the placebo response?

A

One is that there is nothing wrong with placebo responders in the first place, and the second is that a fixed proportion of people, usually around 30 per cent, are placebo responders.

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18
Q

What are some of the explanations for the placebo effect? Give four

A

physiological mechanisms (where fear or anxiety increase production of adrenaline and noradrenaline, which through feedback inhibition modulates the pain response

classical conditioning (where pairing conditioned and unconditioned stimuli eventually result in the conditioned stimulus eliciting the same response as the unconditioned)

autonomic nervous system activity (which affects neurohormone production such as endorphins

psychological effects such as mental imagery and the behaviour and attitudes of health-care practitioners

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19
Q

Give an example of the placebo effect (hint: it was surgical of mammary gland)

A

The internal mammary artery ligation was once thought to improve angina. This procedure was standard medical practice until studies revealed that, with both subjective and objective evidence, a sham operation produced the same results.

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20
Q

Explain how therapy with a placebo is not the same as no therapy

A

The placebo effect may be a consequence of many factors in the therapist-patient relationship, including the psychological state of the patient, the patient’s expectations and convictions in the efficacy of the method of treatment, and the therapist’s biases, attitudes, expectations, and methods of communication

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21
Q

What are RCT’s?

A

In this method a hypothesis is tested regarding a causal relationship. Any study where subjects are randomized into two or more groups, one of which is the control group

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22
Q

What is a hypothesis?

A

a supposition that a specific cause produces the observed phenomenon.

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23
Q

What must a hypothesis be?

A

The hypothesis must be specific and testable by experiments in which all other variables that might also cause the observation are ruled out.

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24
Q

Describe the essential features of an experiment?

A

there must be a control group. All variables remain constant in the control group. One particular variable is manipulated and the effect is measured in the experimental group. Such experiments produce results that either support or refute the hypothesis, thus the researcher is able to draw a conclusion about the validity of the hypothesis.

25
Q

Describe how to test if sodium increases blood pressure

A

two groups of subjects might be given diets with different amounts of salt. In the first step of conducting such a study volunteers are recruited who meet the selection criteria (e.g., healthy young adults; this is based on inclusion and exclusion criteria). Subjects are then randomly assigned to the different groups. After a few weeks the changes in blood pressure are determined. The experiment may reveal that subjects given the extra salt (the experimental group) had an increase in blood pressure, whereas those given their usual salt intake (the control group) had very little change in blood pressure.

26
Q

How are RCT’s performed?

A

subjects are randomly assigned to one of two groups: the experimental group (given the drug or CAM therapy) and the control group. When planning the trial, it is essential to select inclusion and exclusion criteria for the subjects to be used.

27
Q

What are two types of control groups for RCT’s?

A

Standard treatment and no active treatment

28
Q

What is a standard control group?

A

The experimental group would be given the herb while the control group receives the drug. The results will indicate how effective the herb is in comparison with the drug.

29
Q

What is a no active treatment control group?

A

Used where no effective treatment is available or one may exists but only want to see if the treatment works.

Control group given a placebo or a sham

As an example (in a variation of the previous study) we may give herb X to the experimental group and a placebo to the control group. The results will indicate whether or not the herb has any effect on the symptoms of depression.

30
Q

What is a sham or placebo in a drug trial?

A

an inert substance that is indistinguishable from the intervention treatment in appearance and mode of administration.

31
Q

When might more than one experimental group be used?

A

This may be done when, for example, the investigators wish to test different doses or different test substances.

32
Q

Why are tests called double blind?

A

The test is called double-blind because neither the investigators nor the subjects know who is receiving which treatment. Only when the data from all subjects have been recorded do the investigators find out which subjects received the test substance and which the placebo.

33
Q

Why is blinding important in an RCT for patients and researchers?

A

Blinding of patients is necessary because of the placebo effect and to ensure that patients are not biased in how they describe their response to treatment.

Blinding of investigators is necessary to ensure that they do not impart an extra dose of placebo effect to patients, which could happen unintentionally, and also to prevent biases interfering with accurate recording of results.

34
Q

What are double blind controlled trials ideal for?

A

investigating the effectiveness of drugs because a placebo is easily substituted for the drug.

35
Q

Explain how you might test acupuncture in a single blind control trial

A

Many trials to investigate the effectiveness of acupuncture use needling in sites away from classical point locations.

Depth of insertion and stimulation are the same, only the locations differ. This procedure, which is termed sham acupuncture, has been shown to have an analgesic effect in 40 to 50 per cent of patients, in comparison with 60 per cent for real acupuncture

Other forms of controlled trial might include randomizing subjects to receive CAM therapy or conventional therapy. An investigator can subsequently evaluate the subjects and compare the progress of the two groups using standard criteria that allow objective evaluation.

36
Q

When and why is ethical approval needed?

A

required for all research that involves humans.

done in order to protect the patient or subjects from harmful practice and ensure that the patient is not denied any essential treatment.

37
Q

What are ethical considerations that are used?

A

Ethical considerations include informed written consent, right to privacy, right to self-dignity, assured confidentiality, freedom from harm, and right to withdraw from the trial at any time.

38
Q

What is the first step in evaluating research?

A

determine if there is any bias and if the study is published in a reputable journal

39
Q

What should you consider before drawing any conclusions of a study?

A

consider whether the population being studied is comparable to the one you are interested in.

40
Q

what does a statistical positive result mean?

A

If the treatment achieves positive results, this should be reflected in a statement that the difference was “significant.” This means that the probability that the observation occurred by chance was less than one in 20. This is written as p

41
Q

What are three points for statistical significance to keep in mind when examining statistics?

A

The larger the difference between the test and control groups, the lower the p value.

The larger the sample size, the less likely is it that the findings are due to mere chance, and therefore the lower the p value.

The reliability of the statistical analysis can be no greater than the quality of the data.

42
Q

What are type one errors? When do they show up?

A

statistical errors where a significant difference was reported but in reality the difference was due to chance.

This error can arise from the investigator making multiple comparisons until a statistically significant relationship between two variables is obtained.

43
Q

What are type II errors? What needs to be assessed?

A

occur when a real difference exists between two groups but the number being studied is inadequate to demonstrate statistical significance.

the number of patients in the study needs to be assessed.

44
Q

What is publication bias?

A

a type II error where the tendency for investigators to seek, and journals to accept, studies in which a positive result is observed and a significant difference is demonstrated.

45
Q

Why must collection means be evaluated?

A

Measurements and recording of information must be accurate. If a practitioner claims to be successful in treating people afflicted with a deadly disease, such as cancer or AIDS, then the most significant evidence would be patient survival

46
Q

What is a systematic review?

A

investigators look for all published studies on a particular topic.

47
Q

What is Ockham’s razor?

A

Simpler explanations are, other things being equal, generally better than more complex ones. We accept the more complex explanation only if it is clearly more consistent with the observations.

48
Q

How can the media affect a treatment?

A

Often they only report one single finding and they are often overly enthusiastic about the finding.

Usually they have insufficient information as to the risk and costs of the medication

49
Q

What characteristics are available for an internet source on CAM therapies?

A

a reliable source of information is a website maintained by a professional organization whose members have appropriate qualifications. Likewise, websites for government agencies are, in general, also trustworthy.

50
Q

What are untrustworthy websites?

A

websites run by commercial organizations have the primary goal of selling products. Honesty is often the first casualty with such websites and they generally have little credibility. Other websites are run by organizations that are giving a particular point of view, such as that promoting a particular type of CAM therapy.

51
Q

What are the benefits and challenges of using the double–blind randomized control study methodology to test a CAM therapy?

A

Benefits: one major strength of the double–blind RCT lies in the process of randomization, which increases the likelihood that study participants will be similar in all respects other than their exposure to the intervention. A second major advantage is the lack of bias by using a double-blind methodology. Diifferences observed at the end of the trial can then be attributed to the true effect of the intervention.

Challenges or weaknesses: setting in which the double–blind RCT is undertaken is likely to be different from the real world setting of clinical practice and, therefore, results may not be easy to generalize. Random allocation of subjects is not always feasible. It may not always be possible to blind people as to whether or not they are receiving the active treatment.

52
Q

What factors need to be considered when you are reading promotional literature about a therapy?

A

Review the unit commentary titled “Evaluation of Research.”

53
Q

How would you determine if an internet site is a credible source of information?

A

Look at the source (who is involved, credentials), currency (date last modified), content (accurate, complete, references cited, review process, disclaimer, readability), disclosure (purpose, intention, audience, advertising disclosure), and design (links to other sites, area to provide feedback)

54
Q

Discuss how having a vested interest in recommending a treatment or a therapeutic intervention can affect objectivity.

A

For someone to criticize the value of a treatment that he or she has a vested interest in may mean a significant financial loss. That person may truly believe that he or she is being honest and objective, but we may judge their opinions as unreliable.

55
Q

What is publication bias?

A

Publication bias refers to the tendency for only positive results to be published. Consequently, if a literature search finds several studies all supporting a particular treatment, it is possible that there are other studies supporting the opposite result that were not published.

56
Q

Outline the major issues that arise when using observational evidence as the sole supporting evidence for a medical therapy. Often case studies are used to illustrate the effects of a CAM therapy. Explain why you would agree or disagree with this approach.

A

Observational evidence is subject to numerous biases. For instance, the patient may be biased in his or her reporting and the observer may be biased in how he or she interprets information. Case studies may be used to illustrate a particular therapy but, where possible, should be combined with other lines of evidence or else the observations cannot be relied on.

57
Q

Why is the public often confused about health information presented in the media?

A

Contradictory reports on various therapies or treatments are often reported in the media and this generates confusion.

58
Q

What is meant by inclusion and exclusion criteria?

A

Review the section titled “Randomized Controlled Trials.”