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Study population
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• Characterisation of the routine and optimal indication and population, respectively for the therapy (where appropriate with modifications); for what kind of patients with the same or similar conditions are alternative therapies favoured?
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• Which diagnostic tests are routinely used in the diagnostic procedure?
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• Where possible, typical and optimal patient characterisation in relation to:
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| | ○ Severity of the illness |
| | ○ Duration of illness |
| | ○ Intra-individual variability |
| | ○ Age |
| | ○ Gender |
| | ○ Further socio-demographic characteristics |
| | ○ Therapy preferences and expectations |
| | ○ Symptoms of adverse effects of the interventions |
| | ○ Accompanying illnesses |
| | ○ Accompanying medication |
| | ○ Further prognostic or therapy relevant parameters? |
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• Therapy expectation for the "everyday" or "optimal" population (are these discussed with the patients)? Data on course of illness without treatment?
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• Other than the aforementioned characteristics?
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• Which patients are not suitable for the intervention and why?
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Intervention und Control
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• Which are the most commonly prescribed or best effective drugs/interventions for the indication/illness in question (gold-standard), and how do they differ from the investigational drug/intervention? When will the study intervention be selected, when the therapy alternative?
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• In case of medication, usual dosage of the therapy; is this related to the optimal effect? (Or is this a reduced dose due to adverse effects?)
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• Routine method of application of the therapy, is this also the optimal application?
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• Routine therapy duration? (Or by continuous application: after which period of time is a treatment-free interval considered? When are possible changes to alternative medications considered?)
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• Usual accompanying treatments in the therapy of the illness?
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• Usual accompanying therapies for commonly associated illnesses? Are interactions with investigational or similar drug/intervention known?
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• Are typical characteristics of the drug/intervention known (e.g. taste, odour, or local irritation following application, whereby the intervention can become "un-blinded")?
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• Known adverse effects of the intervention?
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• Context factors of the usual or optimal interventions treatment (e.g. individual modification of therapy, therapy expectation of the physician and patient, kind of medical care, accessibility to the therapy)?
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Outcome measurements, results and evaluation
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• What are the relevant outcomes for the patients (or their relatives) in practice?
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• Which parameters are routinely assessed for the progress evaluation of the illness/indication?
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• Which outcome measurements best reflect the intervention's efficacy?
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• What are the routine assessment procedures for the chosen outcome measurements and their clinically relevant threshold values?
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• Is intra-individual variability in illness progress accounted for?
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• What are the routine conditions for the test procedure?
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• What are the optimal conditions for the representation of the intervention efficacy?
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• When will the intervention effect become apparent (earliest, latest)?
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• When are adverse or rebound effects expected after termination of the application?
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• Estimate of the compliance for the intervention (in comparison to alternative therapies), reasons for non-compliance or dropouts, for what reasons is the intervention terminated, after what average time period?
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• (Questions regarding the model validity of individual studies may at best be answered by topic experts)
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Study design and setting
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• What are the clinically relevant research questions?
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• Characteristics of best cases/settings and worst cases/settings for the treatment?
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• Description of the standard treatment setting (and variability), and optimal setting?
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• Are there specifically relevant factors for the indication or therapy?
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• Which physicians have the most experience with the intervention or the indication (practice/clinic, speciality, level of training, experience)?
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• Typical first and subsequent contact with the intervention from the patient's perspective?
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• Time and effort for medical care in routine and optimal situations? Other relevant context factors (e.g. trust in therapy and/or physician)?
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• Time and effort for routine and optimal documentation?
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• (For hypothesis testing without comparison group: Is the reference value clinically relevant?)
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• Where appropriate: Consult specialists for an evaluation of the closeness to practice of individual studies or other factors concerning EV and MV.
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