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Related Concept Videos

Clinical Trials01:16

Clinical Trials

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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Assumptions of Survival Analysis01:15

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Survival models analyze the time until one or more events occur, such as death in biological organisms or failure in mechanical systems. These models are widely used across fields like medicine, biology, engineering, and public health to study time-to-event phenomena. To ensure accurate results, survival analysis relies on key assumptions and careful study design.
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Longitudinal Studies01:26

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Longitudinal studies are also widely used in other medical and social science fields. For instance, in cardiovascular research, they can monitor patients' health over decades to identify risk factors for heart disease, such as high cholesterol or smoking, and evaluate the long-term effectiveness of preventive measures. Similarly, in mental health studies, researchers might follow individuals from adolescence into adulthood to understand the development and progression of conditions like...
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Longitudinal Research02:20

Longitudinal Research

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Sometimes we want to see how people change over time, as in studies of human development and lifespan. When we test the same group of individuals repeatedly over an extended period of time, we are conducting longitudinal research. Longitudinal research is a research design in which data-gathering is administered repeatedly over an extended period of time. For example, we may survey a group of individuals about their dietary habits at age 20, retest them a decade later at age 30, and then again...
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Imaging Studies II: Ultrasonography01:24

Imaging Studies II: Ultrasonography

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An Investigation of the Effects of Sports-related Concussion in Youth Using Functional Magnetic Resonance Imaging and the Head Impact Telemetry System
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Simple steps to develop trial follow-up procedures.

Ona McCarthy1, Rebecca S French2, Ian Roberts3

  • 1Department of Population Health, London School of Hygiene and Tropical Medicine, Keppel St, London, WC1E 7HT, United Kingdom. ona.mccarthy@lshtm.ac.uk.

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|January 16, 2016
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Summary
This summary is machine-generated.

Developing practical follow-up procedures for clinical trials, informed by systematic reviews and participant feedback, significantly improved participant retention. This user-centered approach enhanced completion rates for questionnaires and chlamydia testing in a sexual health intervention study.

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Area of Science:

  • Clinical Trials
  • Public Health Interventions
  • Sexual Health Research

Background:

  • Loss to follow-up in randomized controlled trials (RCTs) compromises statistical power and introduces bias.
  • High rates of participant attrition are common, with nearly half of trials failing to meet follow-up targets.
  • Existing statistical methods and systematic reviews offer limited practical guidance for developing effective follow-up procedures.

Purpose of the Study:

  • To describe the development of practical follow-up procedures for a pilot RCT of a sexual health intervention.
  • To identify and implement effective strategies to maximize participant follow-up and data collection.
  • To address barriers to follow-up completion through user feedback and iterative refinement.

Main Methods:

  • Systematic review of effective follow-up strategies.
  • Development and testing of prototype follow-up procedures.
  • Qualitative feedback collection from trial participants on proposed methods.
  • Iterative revision of procedures based on user input and identified barriers.

Main Results:

  • 17 strategies were identified, with 12 implemented.
  • Identified issues included non-fitting postal test kits and complex instructions.
  • User feedback led to simplified instructions, appropriately sized kits, pre-notification, and colored envelopes.
  • Achieved 92% questionnaire follow-up at 1 month and 82% at 12 months.
  • Achieved 86% chlamydia test follow-up at 3 months and 80% at 12 months.

Conclusions:

  • A user-centered approach, combining systematic review findings with participant feedback, resulted in higher follow-up rates compared to previous sexual health trials.
  • The developed procedures demonstrated success in improving participant retention.
  • Attribution of the response increase solely to the follow-up procedures could not be definitively determined.