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Study population – assessment of selection bias (related to EV)
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• To what extent do the inclusion and exclusion criteria (where relevant, other selection criteria) define the "everyday or target population" of the intervention?
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• Does the applied diagnostic procedure reflect everyday conditions and the everyday possibilities (access, necessity) respectively?
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• Are the diagnostic procedures and evaluations performed by persons with similar qualification and experience as in everyday practice?
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• Does the study population reflect the everyday population in terms of:
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| | ○ Severity of the illness |
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| | ○ Duration of illness |
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| | ○ Intra-individual variability |
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| | ○ Age |
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| | ○ Gender |
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| | ○ Further socio-demographic characteristics |
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| | ○ Therapy preferences and expectations |
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| | ○ Symptoms of side effects of the interventions |
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| | ○ Accompanying illnesses |
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| | ○ Accompanying medication |
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| | ○ Further prognostic or therapy relevant parameters? |
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• Has the structural similarity between the study and the everyday population or target population been tested?
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Intervention und control – assessment of performance bias (related to EV)
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• Does the preparation (medication, other medicinal products, other kind of interventions) reflect the usual treatment?
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• In case of medication, does the dosage reflect the usual treatment? (Is dose modification possible?)
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• Does the type of administration reflect the usual treatment?
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• Does the intervention duration reflect the usual treatment duration?
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• Are the permitted accompanying treatments the usual accompanying treatments?
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• Does the study situation reflect the common treatment situation?
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• Are the interventions carried out by therapists with similar qualifications and experience as in everyday practice?
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Outcome measurements, results and evaluation – assessment of detection and attrition bias (related to EV)
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• Are the chosen outcomes practice and patient relevant? (E.g. no surrogate parameter, are individual therapy goals defined?)
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• 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)?
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• Are the test procedures used in usual practice?
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• Are the tests and evaluations performed by persons with similar qualifications and experience as in every day practice?
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• Are the differences clinically relevant?
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• Were sufficient data collected to cover the intra-individual variability?
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• Do the test conditions reflect the everyday practice?
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• 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?
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• Is clinical relevance considered in the conclusion?
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Study design and Setting (related to EV)
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• Is the research question clinically relevant?
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• Does the study design ensure a high EV?
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• Does the study setting reflect the everyday conditions?
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• 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)?
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• Does the doctor/therapist-patient relationship reflect the everyday conditions (e.g. frequency of contact, constant contact person)?
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