Table 1
Questions and Considerations When Developing an Electronic PRO Questionnaire Platform
| Catagory | Questions | Considerations |
| Questionnaire platform | Paper vs. electronic? | Cost, development time, data volume |
| If electronic, what hardware type (Web, PDA, IVR)? | Cost, hardware availability, training, maintenance | |
| Internal software development vs. third-party product? | Cost, time, technical support, updates | |
| Data storage in standard/exportable format? | Yes, because cannot anticipate future needs | |
| Questionnaire content | Use existing instrument vs. original development? | Objectives of research/data use |
| Verify adequate validation of instrument? | Re-validation for major modifications | |
| Appropriate to target population? | Prior use in similar patients or disease | |
| PHI privacy | Institutional privacy review? | Privacy board or IRB, HIPAA officer |
| Security (polarized) screens on monitors? | Computer locations | |
| Password protection? | Encryption, user modification, secure recovery | |
| Remote access to system vs. limited local access? | Objectives of research | |
| Disclaimer at login? | Legal/liability issues | |
| Data security | Institutional security review? | IRB, IS department |
| Secure system configuration and database? | System validation, automated audit trail | |
| Login timeout? | Functionality, institutional requirements | |
| Patient safety | Automated warnings for concerning responses? | Content of questionnaire items, liability, safety |
| Remote access to previously entered data? | Objectives of system, privacy, security |
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PRO = patient reported outcomes; PDA = personal digital assistant; IVR = integrated voice response; PHI = protected health information; IRB = institutional review board; HIPAA = Health Insurance Portability and Accountability Act; CAT = computerized adaptive testing; IRT = item response theory; IS = Information Services; UAT = user acceptance testing.
