Table 3.
Amendments to the beta version of COMPASS following feasibility testing in the clinical setting
| Amendment | Rationale |
|---|---|
| Revisions to decision analytic model | • Enhanced clinical face validity of predicted outcomes and accuracy of predicted risk of SICH |
| o Time horizon of three months for predicted outcomes (independence, dependence and death) | |
| o Inclusion of new scoring model for risk of symptomatic intracranial haemorrhage, which necessitated the addition ‘current use of Clopidogrel’ and ‘history of hypertension’ to the list of patient details | |
| Inclusion of the additional features: | • Enhanced clinical utility and interpretability |
| o rt-PA dosage calculator, with a pop-up icon displaying detailed dosage figures | |
| o Glucose conversion tool (mg/dl to mmol/L) | |
| o Line graph incorporated into timeline function to show more clearly the decrease in likely benefit from thrombolysis as a function of stroke onset time to treatment | |
| Amendments to list of patient details and warning messages: | • Enhanced clinical face validity and usability, reduced risk of data entry errors and security with data validation |
| o Amended warning for entered NIHSS values < 5 and > 25: “The license states that a minor neurological deficit or severe stroke as assessed clinically (NIHSS > 25) are relative contraindications to treatment with rt-PA. For patients with mild stroke the risks may outweigh the expected benefit. Patients with very severe stroke are at increased risk of intra-cerebral haemorrhage.” | |
| o Rules for number of integers that need to be entered for onset time, target treatment time, age, systolic blood pressure, glucose and weight); e.g. users must enter >1 and <4 integers for systolic blood pressure | |
| o Signs of early infarction on CT/MRI scan replaced with ‘Signs of current infarction at baseline imaging’ | |
| o Larger text boxes for two patient details: systolic blood pressure and glucose (BM) | |
| o Added flexibility for stoke onset time and target treatment time – users can enter values in multiple formats (hhmm, hh:mm, hh.mm) | |
| Amendments to the risk presentations: | • Enhanced interpretability of predicted clinical outcomes |
| o Addition of time horizon for SICH ‘within 24–36 hours after clot-busting treatment’ | |
| o Added to whitespace area: “Please note: predicted clinical outcomes at 3 months apply to patients with pre-stroke modified Rankin scores of 0 to 2” | |
| Other amendments to the user interface: | • Enhanced usability and |
| o Inclusion of ‘acute ischaemic stroke’ to header ‘predicted clinical outcomes’ | • acceptance of the decision aid |
| o Disabled copy/paste function (tablet computer only) | |
| o Inclusion of readability statistics and production date |