Categories | Items |
---|---|
Study population | • 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? |
• Which diagnostic tests are routinely used in the diagnostic procedure? | |
• Where possible, typical and optimal patient characterisation in relation to: | |
○ 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? | |
• Therapy expectation for the "everyday" or "optimal" population (are these discussed with the patients)? Data on course of illness without treatment? | |
• Other than the aforementioned characteristics? | |
• Which patients are not suitable for the intervention and why? | |
Intervention und Control | • 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? |
• 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?) | |
• Routine method of application of the therapy, is this also the optimal application? | |
• 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?) | |
• Usual accompanying treatments in the therapy of the illness? | |
• Usual accompanying therapies for commonly associated illnesses? Are interactions with investigational or similar drug/intervention known? | |
• Are typical characteristics of the drug/intervention known (e.g. taste, odour, or local irritation following application, whereby the intervention can become "un-blinded")? | |
• Known adverse effects of the intervention? | |
• 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)? | |
Outcome measurements, results and evaluation | • What are the relevant outcomes for the patients (or their relatives) in practice? |
• Which parameters are routinely assessed for the progress evaluation of the illness/indication? | |
• Which outcome measurements best reflect the intervention's efficacy? | |
• What are the routine assessment procedures for the chosen outcome measurements and their clinically relevant threshold values? | |
• Is intra-individual variability in illness progress accounted for? | |
• What are the routine conditions for the test procedure? | |
• What are the optimal conditions for the representation of the intervention efficacy? | |
• When will the intervention effect become apparent (earliest, latest)? | |
• When are adverse or rebound effects expected after termination of the application? | |
• 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? | |
• (Questions regarding the model validity of individual studies may at best be answered by topic experts) | |
Study design and setting | • What are the clinically relevant research questions? |
• Characteristics of best cases/settings and worst cases/settings for the treatment? | |
• Description of the standard treatment setting (and variability), and optimal setting? | |
• Are there specifically relevant factors for the indication or therapy? | |
• Which physicians have the most experience with the intervention or the indication (practice/clinic, speciality, level of training, experience)? | |
• Typical first and subsequent contact with the intervention from the patient's perspective? | |
• Time and effort for medical care in routine and optimal situations? Other relevant context factors (e.g. trust in therapy and/or physician)? | |
• Time and effort for routine and optimal documentation? | |
• (For hypothesis testing without comparison group: Is the reference value clinically relevant?) | |
• Where appropriate: Consult specialists for an evaluation of the closeness to practice of individual studies or other factors concerning EV and MV. |