Nutrition in Health and Disease HC 02-09-
2019
Rules and Regulations
To do:
inschrijven voor project groepen
preparation body composition practice quiz
voeg dingen van de slides toe
gedeelte van clinically relevant difference uitwerken vanuit slides
Writing a research proposal
http://english.ccmo.nl/investigator/standard-research-file
Research question: based on knowledge, knowledge gap, scientific
relevance.
P = population
I = intervention
C = comparison
O = outcome
Background:
Broad context + clinical / social relevance.
What is already known about this topic.
Scientific relevance
Research question / aim
(hypothesis)
Study design research proposal
Budget: salary, equipment, laboratory costs, education, office equipment,
travel costs for participants. Write a giant proposal to get funding.
Population: inclusion, exclusion, sample size calculation
Why sample size calculation?
Small sample size: false negative conclusion
Large group: effective too many missed out (type II) ineffective: too
many have been exposed to this ineffective intervention
, Desired power of the study: how certain do you want to be of
preventing a type II error
Desired significant level: how certain do you want to be of
preventing a type I error
Desired test direction: one or two sided
Beta: desired power of the study (1-b), how certain do you want to
be of preventing a type II error: 80% - accepting a chance of 20% of
failing to detect an effect that is indeed present in the population
(false negative).
Alpha: desired significance level, how certain do you want do be of
preventing a type I error: 5% - accepting a chance of 0.05 to detect
an effect in your study that is not present in the whole population
(false positive)
V: Clinically relevant difference: which difference or which effect are
you trying to find? From literature.
Zigma: expected variance, how much variation is expected in
subjects belonging to the same study group? From pilot data or
literature.
Attrition rate, anticipate on the number of included subjects who will
be available for the study analysis. Expected drop-out / withdrawal
from previous studies e.g. if 10% drop-out is expected divide
number needed by 0,9.
Study design: dbRCT preferred, flow chart
Treatment of subjects: intervention
Methods: primary, secondary outcomes
Difference in means, difference in proportions
,Ethical considerations: control, recruit, phone call to participate, insurance,
who does randomization
1. write proposal
2. present protocol to department
3. prepare protocol for Scientific Research Group
4. prepare protocol for METC
5. prepare logistics
WMO
Medisch Wetenschappelijk Onderzoek met mensen - Medical Research
Involving Human Subjects Act
Research falls under the WMO when the following criteria are met: medical
scientific research, patients are subjects to procedures, are required to
follow rules of behaviors, or asked personal questions.
When WMO examples: new treatments, may questionnaires, invasive
measurements, personal questions.
What to do next?
The time line of study approval
, Make an investigator site file with all important research documents.
Make case report forms (CFR) for writing down the data.
Set up a database; no personal data in database!
Make arrangements with the involved departments on the
measurements you planned.
Paperwork (stock of patient information letters, case report forms)
Training of staff
Etc.
Declaration of Helsinki: Good Clinical Practice (GCP) protection of humans
(ethical principles, protection of personal information, safety procedures)
2019
Rules and Regulations
To do:
inschrijven voor project groepen
preparation body composition practice quiz
voeg dingen van de slides toe
gedeelte van clinically relevant difference uitwerken vanuit slides
Writing a research proposal
http://english.ccmo.nl/investigator/standard-research-file
Research question: based on knowledge, knowledge gap, scientific
relevance.
P = population
I = intervention
C = comparison
O = outcome
Background:
Broad context + clinical / social relevance.
What is already known about this topic.
Scientific relevance
Research question / aim
(hypothesis)
Study design research proposal
Budget: salary, equipment, laboratory costs, education, office equipment,
travel costs for participants. Write a giant proposal to get funding.
Population: inclusion, exclusion, sample size calculation
Why sample size calculation?
Small sample size: false negative conclusion
Large group: effective too many missed out (type II) ineffective: too
many have been exposed to this ineffective intervention
, Desired power of the study: how certain do you want to be of
preventing a type II error
Desired significant level: how certain do you want to be of
preventing a type I error
Desired test direction: one or two sided
Beta: desired power of the study (1-b), how certain do you want to
be of preventing a type II error: 80% - accepting a chance of 20% of
failing to detect an effect that is indeed present in the population
(false negative).
Alpha: desired significance level, how certain do you want do be of
preventing a type I error: 5% - accepting a chance of 0.05 to detect
an effect in your study that is not present in the whole population
(false positive)
V: Clinically relevant difference: which difference or which effect are
you trying to find? From literature.
Zigma: expected variance, how much variation is expected in
subjects belonging to the same study group? From pilot data or
literature.
Attrition rate, anticipate on the number of included subjects who will
be available for the study analysis. Expected drop-out / withdrawal
from previous studies e.g. if 10% drop-out is expected divide
number needed by 0,9.
Study design: dbRCT preferred, flow chart
Treatment of subjects: intervention
Methods: primary, secondary outcomes
Difference in means, difference in proportions
,Ethical considerations: control, recruit, phone call to participate, insurance,
who does randomization
1. write proposal
2. present protocol to department
3. prepare protocol for Scientific Research Group
4. prepare protocol for METC
5. prepare logistics
WMO
Medisch Wetenschappelijk Onderzoek met mensen - Medical Research
Involving Human Subjects Act
Research falls under the WMO when the following criteria are met: medical
scientific research, patients are subjects to procedures, are required to
follow rules of behaviors, or asked personal questions.
When WMO examples: new treatments, may questionnaires, invasive
measurements, personal questions.
What to do next?
The time line of study approval
, Make an investigator site file with all important research documents.
Make case report forms (CFR) for writing down the data.
Set up a database; no personal data in database!
Make arrangements with the involved departments on the
measurements you planned.
Paperwork (stock of patient information letters, case report forms)
Training of staff
Etc.
Declaration of Helsinki: Good Clinical Practice (GCP) protection of humans
(ethical principles, protection of personal information, safety procedures)
