Clinical Data Interchange Standards Consortium (CDISC)
August 22, 2024
No Comments
Established instruments for studies are just one of several elements that are essential to clinical trials’ effectiveness. Validated questionnaires are one of the evaluation instruments for this purpose. An accurate evaluation of the study endpoint is a critical component of clinical trials.
Feedback from patient questionnaires given to healthcare professionals may have a modestly positive. Effect on communication between patients and providers and a minimally positive impact on patients’ quality of life.1 Clinical trials are becoming more and more dependent on questionnaires from physicians and patients. As well as visual analogue scales and rating scales for assessing efficacy, safety, quality of life (QoL), utilization of resources, and medical costs.
The positive aspect of having novel treatments that can give equal attention to both the efficacy of the treatment. And the side effects that it can produce on a daily basis is that patients have been asking for an increasing amount of patient involvement in the conduct of clinical research. The way doctors and researchers treat patients has also begun to change. They are beginning to adopt precision medicine techniques that consider each patient as an individual. Patient-reported outcomes (PROs) allow for the direct collection of personal data from patients. Which would not be feasible without them, and the acquisition of more precise and structured data.
If a new questionnaire is to be designed, testing will show that it reliably and accurately measures. The following types of questions are employed while creating questionnaires for clinical trials:
Open-ended questions: Participants may write text in the space provided by open-ended questions to respond. These can be applied when there are many potential answers, and it is crucial to record every aspect of the given information.
Closed-ended questions: They must either only have answer choices that are mutually exclusive or clearly state that participants may choose more than one answer (such as “tick all that apply”).
If participants are asked ancillary questions (or “branching off”) based on their responses to the main questions. More information about the outcomes will be provided, but the questionnaire’s length will increase and it may be more difficult to understand.
It is possible to anticipate that fewer volunteers will sign up for longer and harder tasks than for shorter and simpler ones. The finding that “shorter is preferable” when it comes to questionnaire design appears. To be supported by the data from randomized studies of questionnaire length in a variety of scenarios. It will be more effective for the study to employ the shorter version of an outcome scale. If it yields measures of an outcome that are strongly associated with the longer version.2
There are two types of questionnaires: generic and specific. Generic questionnaires can be used with a variety of populations and can measure a wide range of variables. The EuroQol (EQ-5D), a frequently used patient-reported outcome (PRO), assesses a patient’s overall health state using 5 health dimensions: personal care, mobility, daily activity, pain/discomfort, and anxiety/depression. There are further questionnaires available for assessing symptoms. From anemia (such as the FACT-An) to something a little more comprehensive, such as the QLQ-C30, the most commonly used PRO for any sort of cancer.
The design of a self-administered questionnaire is just as significant as the questions themselves. The following are some factors that should be taken into account while developing a questionnaire layout:2
Self-administered questionnaires typically cost less to use because they don’t need any further input from the investigator beyond distribution. Self-administered surveys have less input from the investigators. Therefore, they are less prone to information bias but more prone to item non-response.
When administering in person, it is possible to establish rapport with participants by. For instance, making eye contact, active listening, and using body language. Additionally, it enables interviewers to examine replies and clarify queries. It is also possible to mix up the modalities of administration; for instance, participant follow-up could start with mailing or emailing the questionnaire. Followed by phone calls to people who didn’t reply.2
There can be several issues related to patient questionnaires. Some common ones include:
Addressing these issues requires careful questionnaire design, clear instructions, validation checks, and follow-up procedures to minimize loss to follow-up. It’s important to consider these factors to ensure the quality and reliability of the data collected through patient questionnaires.
In conclusion, patient questionnaires in clinical trials play a crucial role in gathering important data about participants’ health, symptoms. These questionnaires provide researchers with valuable insights into the effectiveness and safety of the trial. Allowing them to assess outcomes and measure progress. By collecting information directly from patients, these questionnaires contribute to the overall understanding of the impact of a treatment or intervention. They are an essential tool in the research process, helping to improve the quality of clinical trials. Ultimately advance medical knowledge and patient care.
Supporting Healthcare and Pharmaceutical Industries Across Internal, External, and Regulatory Communications. Delivering Top-Tier Support for Our Client’s Success.
Supporting Healthcare and Pharmaceutical Industries Across Internal, External, and Regulatory Communications. Delivering Top-Tier Support for Our Client’s Success.