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RCT > Measuring > Flashcards

Measuring Flashcards

1
Q

What outcomes would you measure?

A
  • mental health (of disease under study), mainly symptoms
  • mental health (comorbid symptoms)
  • mechanisms of therapy change (e.g. cognitions in CBT)
  • functioning in daily life
  • quality of life
  • satisfaction with treatment
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2
Q

mental health (of disease under study)- how would you measure this?

A

Diagnosis vs. symptoms:
Diagnosis: DSM interview –> dichotomous, well understood and accepted, high burden
Symptoms: questionnaire (by therapist or patient) –> continuous (more sensitive to change), lower burden, more difficult to interpret (no gold standard to interpret severity)

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3
Q

how would you measure other outcomes?

A
  • questionnaire
  • hospital records (with permission)
  • behavioral tests or other tasks (e.g. cognition, is sb still afraid of spiders?)
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4
Q

How do you decide that your treatment is effective?

A

you decide based on your primary outcome

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5
Q

primary outcome

A
  • the outcome on which you decide whether your treatment is effective or not
  • also used to calculate how many people you need to include
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6
Q

secondary outcome

A
  • all other outcomes which you think are relevant
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7
Q

How many questionnaires/ or tests can you use?

A
  • no gold standard
  • danger too many questions: drop-out because of burden, unethical when you don’t use data
  • better to use few but well selected measures
  • always test how long it will take patients to fill it out before RCT
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8
Q

How to choose the best instrument/ questionnaire

A
  • literature on your topic/ target group
  • find a number of (frequently used) questionnaires
  • search for additional articles on the questionnaires itself
  • does it measure the concept you are interested in?
  • as short as possible
  • broadly used
  • psychometrically sound (valid, reliable, sensitive to change)
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9
Q

What if there is no questionnaire (in your language)?

A

-translate: backwards and forwards
- establish psychometric properties again
only in very rare cases:
-develop your own questionnaire
- establish psychometric properties

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10
Q

how to administer self-report questionnaires

A
  • paper-and-pencil
  • interview
  • online
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11
Q

when to measure

A
  • baseline always necessary
  • during treatment
  • after treatment (post-test) also necessary
  • follow-ups (e.g., 3 months, 6 months, 1 year)
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12
Q

Why would you (not) measure during treatment?

A
  • interested in overall treatment-effect: not measuring during treatment
  • when treatment is very long: maybe measure during treatment
  • interested in mediating variables: measure during treatment (e.g. in insomnia treatment, what changes first sleep or depression?)
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13
Q

Why would you do follow-ups and how often / for how long?

A
  • you usually want your treatment to work for a long(er) period
  • measure as long as possible
  • be aware: not possible in RCTs with waitlist control group
  • measuring too frequently: people will drop out
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14
Q

blinding

A

being unaware of treatment group

- originally: single vs. double blind trial (patients blinded only vs. patient and experimentor blinded)

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15
Q

What can you blind?

A
  • therapist (often not possible)
  • patient (often not possible)
  • outcome assessor
  • statistician (person doing analysis)
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16
Q

always blind:

A

outcomes that need interpretation:

  • diagnostic interview
  • therapist rated questionnaire
  • test
17
Q

what other things do you need to measure in a RCT?

A
  • safety (suicidal ideation)
  • in- and exclusion criteria
  • descriptives of the sample
  • adverse events
  • treatment uptake and integrity
18
Q

in- and exclusion criteria

A
  • you need to define it and give a clear cut-off (e.g., what is suicidal?)
19
Q

why do you need descriptives of the sample?

A
  • to see if it is a representative sample (of your target group)
  • important for you interpretation
  • important for the readers: do they have similar patients?

gender, age, SES, ethnicity, marital status, history of disease (how long, therapy, pills), comorbid diseases

20
Q

what are adverse events?

A
  • increase of health problems
  • might or might not be sure to your treatment
    e. g, accidents, mental health problems, suicide
21
Q

why measure adverse events?

A
  • should be reported to ethical committee

- important if they are treatment related

22
Q

treatment uptake

A

= how much of the treatment has been done
e.g., treatment protocol prescribes 10 face-to-face sessions but patient only has done 2
but also: how much was the patient involved in the treatment? e.g., how much homework did they do?
online: how many times logged in, stayed online etc.

23
Q

treatment integrity

A

= was the therapy delivered as planned

video taped, checklists…

RCT (16 decks)

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