How to describe outcomes in soft or text trials, specifically in clinical trials with subjective or qualitative data?

From the Guidelines

To describe outcomes in a soft or text trial, it is essential to adhere to the guidelines outlined in the CONSORT-Outcomes 2022 extension, which provides a framework for reporting outcomes in clinical trial reports. This approach ensures that the description of outcomes is clear, specific, and accurately represents the results, prioritizing morbidity, mortality, and quality of life as the primary outcomes. When describing outcomes, begin by stating the primary outcome measures and their results, using precise numerical data when available, as recommended by the guidelines for reporting outcomes in trial reports 1. For example, write "The treatment group experienced a 30% reduction in symptom severity compared to the control group" rather than vague statements like "patients felt better."

Key Considerations for Describing Outcomes

• Include both statistical significance (p-values, confidence intervals) and clinical significance to provide context for the findings, as this helps in understanding the implications of the trial's results on morbidity, mortality, and quality of life.
• Describe secondary outcomes systematically, addressing each pre-specified endpoint, to ensure a comprehensive understanding of the intervention's effects.
• When reporting adverse events or side effects, be specific about their frequency, severity, and relationship to the intervention, as this information is crucial for assessing the safety profile of the treatment and its impact on patient outcomes.
• Use consistent terminology throughout your description to avoid confusion and consider including patient-reported outcomes to provide a more comprehensive picture of the intervention's effects on quality of life and patient-centered outcomes, as emphasized in the study on patient values and preferences regarding VTE disease 1.

By following these guidelines and considering the most recent and highest quality evidence, such as the CONSORT-Outcomes 2022 extension 1, the description of outcomes in a soft or text trial can be accurate, comprehensive, and relevant to clinical practice, ultimately prioritizing morbidity, mortality, and quality of life as the primary outcomes.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Describing Outcomes in Soft or Text Trials

To describe outcomes in soft or text trials, several factors should be considered, including the use of validated assessment instruments and the measurement of health-related quality of life.

• The Brief Pain Inventory (BPI) is a suitable instrument for detecting chronic pain in adults, as it shows good to excellent validity and reliability 2.
• The SF-36 Health Survey is a useful outcome measure for chronic pain patients, as it can detect major depression and demonstrate a dose-effect relationship between depression type and health-related quality of life 3.
• The Multidimensional Pain Inventory (MPI) is more responsive than the SF-36 and the Numeric Rating Scale (NRS) for pain in measuring changes in health and quality-of-life in chronic pain patients 4.
• A modified version of the BPI short form has been shown to be internally reliable, consistent over time, and have good construct, convergent, and predictive validity in assessing patients with osteoarthritis 5.
• The SF-36 can reflect changes in pain status over time and predict pain outcome, making it a useful tool for measuring health status in chronic musculoskeletal pain 6.

Outcome Measurement Instruments

The choice of outcome measurement instrument depends on the specific research question and the population being studied.

• The BPI and MPI are suitable for measuring pain and its impact on daily functions.
• The SF-36 is a useful instrument for measuring health-related quality of life and can detect changes in pain status over time.
• The Numeric Rating Scale (NRS) is a simple and widely used instrument for measuring pain intensity.

Considerations for Soft or Text Trials

When designing soft or text trials, it is essential to consider the following factors:

• The use of validated assessment instruments to ensure accurate and reliable measurements.
• The measurement of health-related quality of life to capture the impact of interventions on patients' daily lives.
• The selection of instruments that are sensitive to changes in pain status and can predict pain outcome.