Collecting data is in many ways a science of its own. You may have to test some ways of engaging participants to get the data in the first place, or new ways to capture it. Luckily, with digital methods, engaging participants and collecting data can be a lot easier. But there are still several things you need to think about in order to get the information you need in an efficient way.
Above all, finding ways to notify participants in an automated way, structuring surveys and forms for organization and clarity, properly educating participants when it comes to certain data collection activities, and integrating external data sources easily are some of the ways you can aim for more efficient data collection.
Structure case report forms for easy completion
When it comes to case report forms, it’s important to think early on how you want the information to be structured and make sure that forms can be filled out easily. Since the purpose of a case report form is to capture safety and efficacy data, designing the form to ensure ease of use and accuracy is paramount to capturing data effectively.
- While open field text can be the better option for certain queries that require nuanced information, drop downs and other predefined fields give data more structure and can reduce entry errors.
- You should always strive to collect what is necessary, seeking to avoid collecting data that ultimately does not serve the aims of the study. It’s also important to capture the most important information first and use a logical order to the form’s questions.
- Be sure to provide clear instructions, and if necessary, to provide definitions for terms. This can help when you are employing ancillary research support staff to do telephone interviews of participants to collect data.
- A modern, user-friendly electronic data capture (EDC) system can be helpful when creating electronic case report forms (eCRFs) because they can automatically validate data, reduce transcription errors, and provide real-time data access. Good EDCs also allow for dynamic forms that can add in tooltips to define complex terms, and branching logic so that forms add in additional questions/parameters as needed.
Educate and notify for remote patient monitoring
Digital methods are incredibly useful for remote patient monitoring in helping you educate and notify participants. And with the right solution in place, you can integrate wearable data into your data collection for remote monitoring and make the experience mobile-friendly.
- Setting up automatic notifications to remind participants to report measures eliminates the need for your teams to manually communicate to participants.
- Alternatively, allowing participants to schedule convenient times of the day to receive notifications may help to spur even better compliance for your trials.
- Education is important when participants are required to take specific measurements that require detailed instructions. A good example is blood pressure.Consider utilizing video and other visuals to help participants learn how to take accurate measurements so that data can be correctly reported.
- Wearables can help automatically monitor participants, sending data to your electronic data capture system at regular intervals. Remember to ask to use participants’ wearable device data in your consent process. It’s also important to make wearable connectivity easy for participants so they can quickly and easily begin sending data from their devices to your study team without support. (read more about how to best integrate wearable data into your studies here.)
- Lastly, mobile friendliness is important especially for study populations that are constantly on-the-go. Smartphones allow for the reporting of data measurements wherever a participant may be so long as they have the measurement devices with them, like a blood pressure monitor. Here are some examples of smartphone apps we have designed for mobile data collection.
Find ways to easily verify treatment compliance
Ensuring that participants comply with treatments in your clinical trials is, like remote monitoring, a matter of reminding them. It also warrants verification in some instances. While you want to be sure you can notify participants in an easy and automated way to keep up with their treatments, you also want to find a way to make sure they are confirming they complied with the treatment protocol.
- One easy way of course is to have them reply ‘Yes’ or ‘No’ when, say, sending an automated SMS message asking them if they complied with treatment that day.
- You can also send push notifications if you are utilizing an app to capture data via a participant’s smartphone to verify treatment compliance.
- In certain cases, more verification is needed. For instance, some populations may be incentivized financially to participate in a decentralized clinical trial without wanting or caring enough to adhere to the treatment. In this case, study teams may want to use photo verification where a participant takes a picture in real-time to verify their adherence.
Make symptom management surveys simple for participants
Symptom management is also about notification, but it is more nuanced when it comes to getting the right responses from participants. Offering automated notifications for daily, weekly, or monthly symptom tracking can help your study staff by reducing their time filling out measures manually. It’s important of course to make sure your surveys follow best practices so that participants can understand and answer questions easily.
Documenting symptom management in an EDC also allows you to automate care triaging in the case of adverse events, serious adverse events, or persistent symptoms. Since monitoring symptoms over time can show significant increases in specific symptoms, you can set up triggers to alert nurses or other care staff who can follow up with participants individually as they experience these events. In this case, you can also trigger notifications back to patients to share information with them to help them manage their symptoms, and to notify them if a nurse or clinical staff will be in touch with them.
Wearables are also highly valuable in managing symptoms that are easily trackable values like heart rate, respiration rate, and so on.
Word and structure ePRO surveys clearly
Getting participants to answer electronic patient reported outcomes (ePROs) like surveys or ecological momentary assessments correctly is all about organizing and wording the questions in a way that makes sense to the participants. You have to consider the age and general health literacy of the populations you are engaging when creating the survey or choosing the right instruments to use.
- Remember to strive for a diverse range of questions to keep it interesting and avoid survey fatigue.
- We also suggest limiting the number of questions per page, and in general to strive for as simple a format as possible.
- Breaking larger surveys into segments can also be helpful to prevent survey fatigue.
- Consider adding interactive elements such as tool tips to define complex terms and media if needed to visually describe a concept.
- Lastly, it’s important to seek feedback on your surveys early and often, and if possible, to engage a survey methodologist to help you design your surveys for optimal performance.
Integrate with EHR, genomics, and wearable data
By integrating EHR, genomics, and wearables data you are simultaneously unlocking opportunities for more data and insights, but it’s important to integrate them carefully. First of all, it’s important to make sure you are properly consenting participants to collect these data.
Platforms like Vibrent’s allow you to give participants the ability to connect their EHR and wearable data to the study, and to order genomics kits directly from sequencing providers. These are done through integrations which allow the data to be accessed by study teams. The data, especially EHR, needs to be harmonized so that all data points fit together in a way that makes sense to the study. While some EHR data points are easily harmonized with software like Vibrent’s, we recommend mapping dispersed datasets using a data dictionary according to FL7/FHIR standards.
Conclusion
Optimizing digital data collection for efficiency is not always a straightforward process and can take some time for you and your research teams to experiment with different methodologies and different ways of engaging your participants. Remember that different studies can call for different strategies, and it’s important to consider what data is necessary to your study and start there. From that point, finding a good case for nice-to-have data that will further help you accomplish your aims, and figuring out a way to collect that data in as easy a manner as possible can be beneficial to gleaning deeper insights from your studies.
Overall, it’s important to find ways to automate your communication with participants to collect data more easily, to structure information for optimal clarity and organization, and to consider integrating datasets in a way that is easy for your study teams to manage. You may choose to do this work with internal resources, or partner with a company like Vibrent Health who can offer tools and expertise designed to allow you to collect more data with a higher quality with less work from your team.
Looking to collect other kinds of data? Reach out to us with your questions and to see what’s possible.
