What is clinical nutrition? Nutritional care for individual patients or patient
groups due to changes in nutritional requirements
caused by illness, treatment, or malnutrition.
What are the consequences of muscle wasting 1. More severe toxicity of treatment 2. Reduced
according to observational studies? functional status 3. Reduced quality of life (QoL) 4.
Reduced survival.
What is the importance of interventions aiming at Clinical outcomes may be improved by interventions
preserving muscle mass in clinical outcomes? aiming at preserving muscle mass.
What is the significance of sufficient protein intake Sufficient protein intake, next to an adequate
and adequate physical activity in inducing muscle physical activity, is of critical importance in inducing
protein anabolism? muscle protein anabolism.
What is the scientific relevance gap in the research What is already known about this topic.
question/aim?
What is the purpose of a sample size calculation? To determine the number of participants needed in
a study to ensure adequate statistical power and
minimize the risk of false conclusions.
What are the two factors that need to be considered The desired power of the study (1-ß) and the
when determining the desired power of a study? desired significance level (α).
What is the significance level in a sample size The significance level is the probability of falsely
calculation? concluding that there is an intervention effect when
there is none (false positive).
What is the clinically relevant difference in a sample The clinically relevant difference is the difference in
size calculation? the outcome variable that is considered meaningful
from a clinical perspective.
Why is it important to consider the variance of the The variance of the outcome variable is important
outcome variable in a sample size calculation? because it affects the precision of the study and the
number of participants needed to detect a
significant difference.
What is the desired significance level for preventing 5%-accepting a chance of 0.05 to detect an effect in
a type I error? your study that is not present in the whole
population (false positive).
What is the clinically relevant (or expected) Which difference or which effect are you trying to
difference (v)? find? - from literature.
,What is the expected variance/standard deviation How much variation is expected in subjects
(σ)? belonging to the same study group? - from pilot data
or literature.
What is the attrition rate? Anticipate on the number of included subjects who
will not 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.
What are the differences in means? Difference in body weight change between groups,
difference in survival time between groups.
What are the differences in proportions? Difference in proportions (%) with a certain weight
loss between groups, difference in proportions (%)
1-year survival between groups. Improvement in
overall survival would be most important!
What is the mechanism of action of loop diuretics? Inhibition of Na+ and Cl- reabsorption.
How do loop diuretics affect renal excretion of water They increase renal excretion of water and Na+.
and Na+?
What is the median survival time for new 20 months.
medications?
What is the standard improvement for new 2 months.
medications?
What is the significance level for the sample size α=0.05.
calculation?
What is the power level for the sample size β=80%.
calculation?
What is the first effect that would be observed Body weight or muscle mass.
before treatment toxicity/quality of life/survival?
How is the effect on muscle mass measured? On CT scan.
What is a Type I error? Falsely rejecting H0.
,What is a Type II error? Falsely accepting H0.
What is WMO? Wet medisch-wetenschappelijk onderzoek met
mensen.
What are the criteria for research to be subject to It concerns medical scientific research and
WMO? participants are subject to procedures or required to
follow rules of behavior that may infringe on their
physical and/or psychological integrity, and the
subject must be physically involved in the research.
What is the Declaration of Helsinki? A standard for Good Clinical Practice (GCP) that
aims to protect humans through ethical principles,
protection of personal information, safety
procedures, etc.
What are the goals of GCP and the Declaration of To prioritize patients' well-being, to aim to
Helsinki? understand diseases and improve treatments, and
to protect human research subjects through ethical
standards and reliable, reproducible research.
What is the first priority of doctors when treating Prioritizing patients' well-being.
patients?
What is the aim of medical research? To understand diseases and improve treatments.
What do ethical standards protect in human Human research subjects.
research?
What comes before research goals in terms of Individual rights.
individual rights?
What should research aim to minimize in terms of Harm to the environment.
the environment?
Who is qualified to conduct research on humans? Only qualified individuals.
What is informed consent in research? Participation must be voluntary and informed.
Subjects must be informed about the study's aims,
risks, and benefits.
When should placebos be used in research? Placebos should be used when scientifically
necessary and ethical.
, What is the requirement for all research involving All research involving humans must be publicly
humans? registered. Researchers must publish all research
results.
What is the protocol for using unproven Doctors may use unproven interventions within
interventions in desperate cases? informed consent, followed by research to evaluate
them.
What is the requirement for participants in research Participants must be actively involved and subject
involving actions that affect their physical or mental to WMO review.
integrity?
What is the purpose of the monitoring board in To guard the safety of patients and quality of
research? research.
What are the quality checks performed in a random Informed consent; In-and-exclusion criteria; Source
test of recruited patients? data verification; Protocol violations; Check of
Serious Adverse Events.
Why are more and more rules, laws, and directives Unethical medical experiments in minorities such as
being implemented in medical research? prisoners, prostitutes, orphans, homosexuals, etc;
Fraud and falsification.
What are the five balances that contribute to Energy in balance; Water in balance; Minerals in
health? balance; Nutrients in balance; Stable metabolism.
What are the consequences of disease on the Weight loss; Dehydration/oedema; Hypo-/hyper...;
body? Catabolism; (pro-)inflamm. changes.
How are carbohydrates formed? Monosaccharides linked together (by condensation)
form di- or polysaccharides.
What are the three types of lipids? Triglycerides (fats and oils) (4-24 carbons long:
MCT/LCT); Phospholipids (lecithin); Sterols
(cholesterol/bile).
What are essential fatty acids? 18-carbon polyunsaturated fatty acids: linolenic.
What are the three types of lipids found in the diet? Oils (4-24 carbons long: MCT/LCT), phospholipids
(lecithin), and sterols (cholesterol/bile).
groups due to changes in nutritional requirements
caused by illness, treatment, or malnutrition.
What are the consequences of muscle wasting 1. More severe toxicity of treatment 2. Reduced
according to observational studies? functional status 3. Reduced quality of life (QoL) 4.
Reduced survival.
What is the importance of interventions aiming at Clinical outcomes may be improved by interventions
preserving muscle mass in clinical outcomes? aiming at preserving muscle mass.
What is the significance of sufficient protein intake Sufficient protein intake, next to an adequate
and adequate physical activity in inducing muscle physical activity, is of critical importance in inducing
protein anabolism? muscle protein anabolism.
What is the scientific relevance gap in the research What is already known about this topic.
question/aim?
What is the purpose of a sample size calculation? To determine the number of participants needed in
a study to ensure adequate statistical power and
minimize the risk of false conclusions.
What are the two factors that need to be considered The desired power of the study (1-ß) and the
when determining the desired power of a study? desired significance level (α).
What is the significance level in a sample size The significance level is the probability of falsely
calculation? concluding that there is an intervention effect when
there is none (false positive).
What is the clinically relevant difference in a sample The clinically relevant difference is the difference in
size calculation? the outcome variable that is considered meaningful
from a clinical perspective.
Why is it important to consider the variance of the The variance of the outcome variable is important
outcome variable in a sample size calculation? because it affects the precision of the study and the
number of participants needed to detect a
significant difference.
What is the desired significance level for preventing 5%-accepting a chance of 0.05 to detect an effect in
a type I error? your study that is not present in the whole
population (false positive).
What is the clinically relevant (or expected) Which difference or which effect are you trying to
difference (v)? find? - from literature.
,What is the expected variance/standard deviation How much variation is expected in subjects
(σ)? belonging to the same study group? - from pilot data
or literature.
What is the attrition rate? Anticipate on the number of included subjects who
will not 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.
What are the differences in means? Difference in body weight change between groups,
difference in survival time between groups.
What are the differences in proportions? Difference in proportions (%) with a certain weight
loss between groups, difference in proportions (%)
1-year survival between groups. Improvement in
overall survival would be most important!
What is the mechanism of action of loop diuretics? Inhibition of Na+ and Cl- reabsorption.
How do loop diuretics affect renal excretion of water They increase renal excretion of water and Na+.
and Na+?
What is the median survival time for new 20 months.
medications?
What is the standard improvement for new 2 months.
medications?
What is the significance level for the sample size α=0.05.
calculation?
What is the power level for the sample size β=80%.
calculation?
What is the first effect that would be observed Body weight or muscle mass.
before treatment toxicity/quality of life/survival?
How is the effect on muscle mass measured? On CT scan.
What is a Type I error? Falsely rejecting H0.
,What is a Type II error? Falsely accepting H0.
What is WMO? Wet medisch-wetenschappelijk onderzoek met
mensen.
What are the criteria for research to be subject to It concerns medical scientific research and
WMO? participants are subject to procedures or required to
follow rules of behavior that may infringe on their
physical and/or psychological integrity, and the
subject must be physically involved in the research.
What is the Declaration of Helsinki? A standard for Good Clinical Practice (GCP) that
aims to protect humans through ethical principles,
protection of personal information, safety
procedures, etc.
What are the goals of GCP and the Declaration of To prioritize patients' well-being, to aim to
Helsinki? understand diseases and improve treatments, and
to protect human research subjects through ethical
standards and reliable, reproducible research.
What is the first priority of doctors when treating Prioritizing patients' well-being.
patients?
What is the aim of medical research? To understand diseases and improve treatments.
What do ethical standards protect in human Human research subjects.
research?
What comes before research goals in terms of Individual rights.
individual rights?
What should research aim to minimize in terms of Harm to the environment.
the environment?
Who is qualified to conduct research on humans? Only qualified individuals.
What is informed consent in research? Participation must be voluntary and informed.
Subjects must be informed about the study's aims,
risks, and benefits.
When should placebos be used in research? Placebos should be used when scientifically
necessary and ethical.
, What is the requirement for all research involving All research involving humans must be publicly
humans? registered. Researchers must publish all research
results.
What is the protocol for using unproven Doctors may use unproven interventions within
interventions in desperate cases? informed consent, followed by research to evaluate
them.
What is the requirement for participants in research Participants must be actively involved and subject
involving actions that affect their physical or mental to WMO review.
integrity?
What is the purpose of the monitoring board in To guard the safety of patients and quality of
research? research.
What are the quality checks performed in a random Informed consent; In-and-exclusion criteria; Source
test of recruited patients? data verification; Protocol violations; Check of
Serious Adverse Events.
Why are more and more rules, laws, and directives Unethical medical experiments in minorities such as
being implemented in medical research? prisoners, prostitutes, orphans, homosexuals, etc;
Fraud and falsification.
What are the five balances that contribute to Energy in balance; Water in balance; Minerals in
health? balance; Nutrients in balance; Stable metabolism.
What are the consequences of disease on the Weight loss; Dehydration/oedema; Hypo-/hyper...;
body? Catabolism; (pro-)inflamm. changes.
How are carbohydrates formed? Monosaccharides linked together (by condensation)
form di- or polysaccharides.
What are the three types of lipids? Triglycerides (fats and oils) (4-24 carbons long:
MCT/LCT); Phospholipids (lecithin); Sterols
(cholesterol/bile).
What are essential fatty acids? 18-carbon polyunsaturated fatty acids: linolenic.
What are the three types of lipids found in the diet? Oils (4-24 carbons long: MCT/LCT), phospholipids
(lecithin), and sterols (cholesterol/bile).
