202 CHAPTER 3.1 Data entry After entering the baseline patient characteristics, the patient’s medical data are entered in five sequential steps: All relevant medical conditions (either chronic or acute) are entered using ICD-10 codes. Surgical interventions not requiring (current) medical treatment are not considered for data input. Coronary artery stent deployment, for example, is entered as this treatment requires antiplatelet therapy for 6–12months. For some medical conditions, the date of onset is important and this can also be entered during this step. All current medications are entered (including those upon admission) at ATC-5 level (generic drug names), including frequency and route of administration. This may differ from the patient’s home medication. Additionally, drugs with a long-term indication that have been withheld upon admission due to the specific nature of the patient’s presenting illness are included, as their re-initiation after hospitalization is likely. 1. All patient-reported signs and symptoms are entered. They are either elicited from the patient during SHiM or found in the medical records or in the laboratory results. A predefined list of signs and symptoms present in START and STOPP criteria in the form of checkboxes is available in STRIPA, and includes for example constipation, dizziness, blurred vision and ankle oedema, among others. Other signs or symptoms can be entered manually and then selected from the Medical Dictionary for Regulatory Activities (MedDRA) database, a medical dictionary developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), integrated with STRIPA. 2. All available vital and laboratory measurements are reviewed. However, only those parameters present within one or more of the STOPP and START criteria are available within STRIPA. These can either be entered manually or selected from the predefined list of parameters present. 3. The final step in the data entry process comprises different measurements, specifically the HAS-BLED score [37], clinical parameters such as urea and electrolyte values, heart rate and blood pressure, patient height and weight as well as the pneumococcal and influenza vaccination status. Additionally, allergies and ADRs can be entered here as plain text.
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