Clinical research benefits immensely from the increased use of digital tools to enhance efficiency, and to enable decentralized clinical trials (DCTs) to happen. DCTs count on remote participation of patients, which can be very convenient, but it also means that researchers may need to be more attentive to ensure engagement and data quality. This is why professional use of questionnaires in decentralized clinical trials is so important.
What You Will Learn in This Article ?
- The role of questionnaires in DCTS
- Best practices to designing and implementing questionnaires
- The benefits of using these digital surveys
- Other aspects to consider when designing patient-centric questionnaires
Questionnaires in Decentralized Clinical Trials
Questionnaires can be used in more than one situation in clinical trials. When it comes to remote clinical research, digital questionnaires are a great tool to capture data without the need for an in-person meeting. Through online forms, researchers can collect information such as patient-reported outcomes (PROs) and symptoms reporting.
Patient-reported outcomes that are electronic based (as opposed to paper-based) are called ePROS. Questionnaires are the main format through which ePROs are collected, and they allow researchers to obtain information about the effects of a treatment or medication in real-time.
Therefore, questionnaires are not just a great tool for data collection, but they can also be at the core of patient engagement, as they are the main channel through which researchers will be collecting participants’ information in a decentralized clinical trial. Digital questionnaires allow for real-time data collection and regular monitoring, enabling the research team to answer patient’s concerns as soon as they are manifested.
Best Practices for Designing Electronic Questionnaires in Decentralized Clinical Trials
Electronic questionnaires can be a powerful tool to enhance decentralized clinical trials and ensure efficient and high-quality data collection as well as maximized patient engagement. This potential is, however, conditional to professional and meticulous design. It is also necessary to plan their implementation very carefully, as problems in administering them can be an obstacle to achieving the best results. In this section, we share some best practices to design and implement patient-centric questionnaires that deliver accurate results.
Build User-Friendly Interfaces
This practice is frequently overlooked, but it should not be. It is easy to underestimate the importance of simple details like font size and color, but they can make all the difference in user experience and, ultimately, in patient engagement. Participants may even quit answering a questionnaire that is difficult to navigate or understand. Some easy adjustments to make a questionnaire interface user-friendly are:
- Use a font size that is not too small or too large, it should be comfortable to read in various screen sizes.
- Use (but do not abuse) images and icons to help navigation.
- Minimize the use of technical jargon.
- Ensure the form pages are responsive in different device types (mobile, tablets and computers).
- Format the questionnaire in a way that helps patients to navigate it, using numbering and bullet points and dividing questions into sections.
Write Simple, Effective and Clear Instructions
Rule number one is conciseness. Nowadays, people are used to receiving information in the form of images and audio, and they are less attracted to extensive blocks of text. Make sure the informative parts of the questionnaire are written in clear and effective language, providing all essential information without discouraging people from reading it.
The questions should also be written with extra care, to ensure that no ambiguity confuses patients and reduce the likelihood of errors and missing data. You may include short reminders between the sections of the questionnaire about the study’s objectives and potential outcomes.
Provide Various Response Options
While this might seem advice that is most oriented towards ensuring the quality of the data delivered, it also may be beneficial to the patient’s experience. Associating single and multiple choice with open-ended questions is useful to have access to a wider variety of participants’ experiences, but it also makes the questionnaire more pleasant to answer.
Ensure the response options that are provided are comprehensive and targeted at the relevant group of respondents. Avoid inconsistencies in data by providing patients with all response options that they might need to reflect their experiences with the treatment.
Make Good Use of Digital Tools
Technology should be used to simplify our lives. The many digital tools available can be a great support to design user-friendly questionnaires and facilitate data management. They allow researchers to use pre-made forms that are customizable, and there are also ways to use technology to automate and enhance questionnaire implementation. Some of the tools that can be used in questionnaire designing and implementation are:
- Electronic platforms: These are very comprehensive solutions which allow researchers to build surveys and also share them with patients, who can access the form using a secure and unique login. They can do this from anywhere that has an internet connection using their own devices.
- Mobile applications: Apps which are designed to complete and submit clinical research questionnaires offer patients the great convenience of always having the survey in their pockets. They are also very useful for participants taking part in symptom monitoring, as apps can be configured to send notifications reminding patients to complete the questionnaire at specific times.
- Text messaging: For groups of patients that prefer simpler, minimal communication platforms, text messaging can be more adequate than mobile applications. The questions can be sent as simple text and responded the same way. It is a classic tool that is still very useful.
- Voice-based technologies: When dealing with groups of patients with visual impairments or with low literacy levels, voice-based technologies can be very helpful to keep them engaged. Patients can listen to questions read by an interactive voice system and respond to them over the phone.
Reduce the Burden on Patients
User-friendly interfaces and concise writing are good practices to ensure patients have a good questionnaire experience. There are other aspects to be considered to further reduce the burden on participants. After all, they are volunteers and responding to the questionnaire should not disturb their routine more than what is absolutely necessary. Some tips to minimize patient burden are:
- Calculate the timing and frequency of questionnaires to be just enough to obtain the necessary data, to avoid wasting patients’ time.
- Communicate the questionnaire deadlines beforehand and ask participants if they need or want to be reminded of the schedule.
- Remember that not all participants will have the same level of digital literacy. Using advanced technology solutions can be very helpful but can also be a source of anxiety to people who are not used to apps or online platforms. Avoid this unnecessary burden by getting to know the participants well.
Offer Ongoing Communication and Support
Regular monitoring is necessary not only to ensure timely data analysis and result delivery, but to help patients stay engaged. After providing them with clear instructions and the complete questionnaire, assure them that communication is still open. Contact information should be displayed in the questionnaire, if they need any kind of support while responding.
Patients should also be able to contact the team at any time if they have questions about the purpose of the research and how their data is going to be used, and they must have their concerns addressed as soon as possible. Inform your team about the importance of good communication and support to ensure that regular follow-up will be provided.
Consider Strategic Data Integration
Questionnaire platforms can be integrated with other research databases and be compared and analyzed together. This can leverage the use of questionnaires in decentralized clinical trials because it can increase quantity and quality of data generated.
Robust data management and integration systems should be used to ensure ethical and legal manipulation of patients’ private information. Carefully assessing the many digital solutions providers available to check their security levels is recommended. Be transparent with patients and make sure they understand how their data is collected and stored.
Benefits of Questionnaire Implementation in Decentralized Clinical Trials
Now that you already know the best practices that will help you implement effective questionnaires, you might want to know the reasons why remote clinical research is becoming more common and gradually replacing traditional site based clinical trials. These are the main benefits that questionnaire implementation may bring to researchers and patients:
- Improved data and research quality: Using digital solutions to collect and analyze data reduces the risk of human errors, generating reliable and accurate results. It also facilitates research continuation and improvement by allowing data from standardized questionnaires applied in different study sites and dates to be compared.
- Remote monitoring: This is beneficial to patients and researchers at the same time. Both groups avoid excessive trips to the study site and can participate remotely through online questionnaires. This also means that more people can participate in the study, since the geographic location is not an obstacle.
- Better patient experience: When responding to a questionnaire that has been designed with a patient-centric approach, participants have a clear picture of how important their participation is and what their role is in the study. This helps them to stay engaged, reduces drop-out rates and leads to overall patient satisfaction and comprehensive data collection.
- Efficient trial timeline management: The use of digital questionnaires allows data to be collected in less time than when using paper-based forms. Less time is also needed to organize and analyze all the data, resulting in more efficient clinical trials and faster result delivery.
Other Aspects to Consider When Implementing Questionnaires in Decentralized Clinical Trials
We have now covered the basics of designing and implementing digital questionnaires in clinical trials, and we have also highlighted some of the benefits of this type of survey that are relevant to researchers and patients. The last part of our comprehensive guide covers less addressed, but still very important, aspects to consider when implementing questionnaires in decentralized clinical trials.
Cultural differences
Because participants can be recruited in many different locations, as remote recruiting can reach people who are far away from the study site, cultural differences need to be taken into account. People from different countries may interpret questions in different ways, changing the kind of response they might provide and altering the expected results. This is not necessarily negative, but it can be a problem if not considered by researchers in the design stage.
Being sensitive to cultural differences means knowing how to phrase questions in a way that the targeted population will not only understand but relate to and accept to respond. It may also include providing translations or explanations of less known terms if the questionnaire is written in a language that is not the participants’ mother tongue.
Relevancy and completeness of data
It can be tempting to include an extensive list of questions when there are advanced tools that make this process a lot easier. However, relevancy of data should be considered to ensure high quality results and keep patients engaged. Ensure participants are presented only with questions that apply to their situation, and that only essential questions are mandatory.
It is also recommended to use real-time monitoring to identify any potential issues while participants are still responding to the questions. Problems with missing data or misinterpretation of questions can be addressed early on and ensure completeness of data. Other quality control measures that can be taken are double data entry and third-party audits.
Compliance and ethics
Compliant questionnaires follow Good Clinical Practice Guidelines and are built using robust data protection systems. It is also important to keep track of the consent acquisition process and ensure that patients are making informed decisions. The questionnaire implementation process should be reviewed and assessed, so if there are any risks of non-compliance they can be avoided and prevented in future questionnaires.
Key Takeaway Points
- Questionnaires are an essential part of decentralized clinical trials, which happen remotely.
- Implementing questionnaires in decentralized clinical trials is beneficial because it improves data quality and patient engagement.
- Some best practices to design and implement questionnaires are creating user-friendly interfaces, providing clear instructions, and offering comprehensive response options.
- Other aspects to consider are cultural differences and legal compliance.
