A more severe issue in terms of (research) ethics is that of the missing "informed consent" in SMA, comprehensively dealt with in Krieger, Grubmüller et al. [36].
Exclusion criteria were trauma within 7 days, chronic headache defined as > 3 months duration, age < 18 years, missing informed consent, and inability to comply with study procedures due to insufficient knowledge of the German language.
On the other hand, patients were excluded if they were of age <17 years, if they were pregnant, if they had missing informed consent either from the patient or the relative, if they participated before in this clinical trial, if they had cancer as the cause of SIRS or sepsis, chronic kidney diseases and if medical staff decided to limit care.
Because of missing informed consent forms or questionnaire data, 548 individuals were excluded, leaving a complete data set of 8,281 individuals (94% of the initial enrollment).
A total of 75 patients who underwent cardiac surgery with CPB were analyzed [inclusion criteria: aged 3 18 years, body weight >12 kg; exclusion criteria: missing informed consent of parents, palliative cardiac surgery (e.g. if single ventricle circulation was the aim of surgery, (Glenn, Fontan or total cavopulmonary connection [TCPC]).
The exclusion criteria were missing informed consent, lack of cooperation capability, American Society of Anesthesiologists (ASA) score >3, rheumatoid arthritis, cancer co-morbidity, alcohol or drug abuse, previous major surgery on the affected joint, neurologic or psychiatric disease, pregnancy, and participation in other clinical studies.
Exclusion criteria were inability or unwillingness to participate, missing or withdrawn informed consent, chronic atrial fibrillation, and known heart failure or pulmonary disease with dyspnea requiring supplemental oxygen.
Exclusion criteria also included: missing BMI information, the informed consent not being signed, and self-reported pregnancy at the time of the examination.
Also, a reminder was sent in case of a missing signature on the informed consent form.
Module Two, "The Art of Medicine," presents topics relating to challenging communication issues including maintaining adolescent confidentiality, addressing hidden agendas, conducting mental status exams in the elderly, confronting patients that miss appointments, and obtaining informed consent.
Attempts are consistently made to avoid missing data and prevent withdrawal of informed consent or lost to follow-up that can compromise the integrity of the study.
