Study population – assessment of selection bias (related to EV)
|
• To what extent do the inclusion and exclusion criteria (where relevant, other selection criteria) define the "everyday or target population" of the intervention?
|
☐
|
☐
|
☐
|
☐
|
|
• Does the applied diagnostic procedure reflect everyday conditions and the everyday possibilities (access, necessity) respectively?
|
☐
|
☐
|
☐
|
☐
|
|
• Are the diagnostic procedures and evaluations performed by persons with similar qualification and experience as in everyday practice?
|
☐
|
☐
|
☐
|
☐
|
|
• Does the study population reflect the everyday population in terms of:
|
☐
|
☐
|
☐
|
☐
|
| ○ Severity of the illness |
☐
|
☐
|
☐
|
☐
|
| ○ Duration of illness |
☐
|
☐
|
☐
|
☐
|
| ○ Intra-individual variability |
☐
|
☐
|
☐
|
☐
|
| ○ Age |
☐
|
☐
|
☐
|
☐
|
| ○ Gender |
☐
|
☐
|
☐
|
☐
|
| ○ Further socio-demographic characteristics |
☐
|
☐
|
☐
|
☐
|
| ○ Therapy preferences and expectations |
☐
|
☐
|
☐
|
☐
|
| ○ Symptoms of side effects of the interventions |
☐
|
☐
|
☐
|
☐
|
| ○ Accompanying illnesses |
☐
|
☐
|
☐
|
☐
|
| ○ Accompanying medication |
☐
|
☐
|
☐
|
☐
|
| ○ Further prognostic or therapy relevant parameters? |
☐
|
☐
|
☐
|
☐
|
|
• Has the structural similarity between the study and the everyday population or target population been tested?
|
☐
|
☐
|
☐
|
☐
|
Intervention und control – assessment of performance bias (related to EV)
|
• Does the preparation (medication, other medicinal products, other kind of interventions) reflect the usual treatment?
|
☐
|
☐
|
☐
|
☐
|
|
• In case of medication, does the dosage reflect the usual treatment? (Is dose modification possible?)
|
☐
|
☐
|
☐
|
☐
|
|
• Does the type of administration reflect the usual treatment?
|
☐
|
☐
|
☐
|
☐
|
|
• Does the intervention duration reflect the usual treatment duration?
|
☐
|
☐
|
☐
|
☐
|
|
• Are the permitted accompanying treatments the usual accompanying treatments?
|
☐
|
☐
|
☐
|
☐
|
|
• Does the study situation reflect the common treatment situation?
|
☐
|
☐
|
☐
|
☐
|
|
• Are the interventions carried out by therapists with similar qualifications and experience as in everyday practice?
|
☐
|
☐
|
☐
|
☐
|
Outcome measurements, results and evaluation – assessment of detection and attrition bias (related to EV)
|
• Are the chosen outcomes practice and patient relevant? (E.g. no surrogate parameter, are individual therapy goals defined?)
|
☐
|
☐
|
☐
|
☐
|
|
• Were the following important outcomes considered: quality of life, subjective health, patient's general evaluations, compliance, reasons for dropout, use of accompanying treatments, rebound effect following termination of treatment (or, for example, symptom deceit)?
|
☐
|
☐
|
☐
|
☐
|
|
• Are the test procedures used in usual practice?
|
☐
|
☐
|
☐
|
☐
|
|
• Are the tests and evaluations performed by persons with similar qualifications and experience as in every day practice?
|
☐
|
☐
|
☐
|
☐
|
|
• Are the differences clinically relevant?
|
☐
|
☐
|
☐
|
☐
|
|
• Were sufficient data collected to cover the intra-individual variability?
|
☐
|
☐
|
☐
|
☐
|
|
• Do the test conditions reflect the everyday practice?
|
☐
|
☐
|
☐
|
☐
|
|
• Does the dropout rate reflect everyday experience? Are the reasons for dropout registered (e.g. adverse effects, insufficient effect), so that the significance for the everyday effectiveness can be assessed?
|
☐
|
☐
|
☐
|
☐
|
|
• Is clinical relevance considered in the conclusion?
|
☐
|
☐
|
☐
|
☐
|
Study design and Setting (related to EV)
|
• Is the research question clinically relevant?
|
☐
|
☐
|
☐
|
☐
|
|
• Does the study design ensure a high EV?
|
☐
|
☐
|
☐
|
☐
|
|
• Does the study setting reflect the everyday conditions?
|
☐
|
☐
|
☐
|
☐
|
|
• Are the investigators the regular contact persons (e.g. GP or relevant clinic doctor, or are they at least comparable in terms of training, status, experience, preferences; does the number of contact people reflect the usual setting)?
|
☐
|
☐
|
☐
|
☐
|
|
• Does the doctor/therapist-patient relationship reflect the everyday conditions (e.g. frequency of contact, constant contact person)?
|
☐
|
☐
|
☐
|
☐
|