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NCT Number: NCT02637622

Measuring the Preferences of Patients With Type II Diabetes Using Best-worst Scaling and Discrete Choice Experiment

In 2012, the FDA Center for Devices and Radiological Health (CDRH) issued guidance to clarify the principal benefit-risk factors FDA considers during the reviews for premarket approval applications and de novo classification requests. In addition to a detailed description of benefits and risks, CDRH listed "patient tolerance for risk and perspective on benefit" as a factor that CDRH may consider in regulatory reviews. It underlined the need for developing methods to measure patient preference and incorporate it into regulatory decision-making. The purpose of this study is to advance methods for patient and community engagement in patient-centered outcome research (PCOR) and has three objectives.

First, demonstrate good practices for patient and community involvement in PCOR projects by applying principles of community-based participatory research (CBPR).

Second, address methodological gaps pertaining to the use of stated-preference methods in studying preferences in PCOR. These include identifying the best methods for designing a preference study and strategies for analyzing variation in preferences. The investigators also seek to assess the relevance of stated-preference methods to patients and stakeholders using both qualitative and quantitative methods.

Third, demonstrate good practices for applying stated-preference methods by studying the preferences of patients with type II diabetes. While type II diabetes provides an important case study, this research will advance approaches and methods that will be broadly generalizable to other diseases, and to diverse patient and stakeholder groups.

Clinical Significance:

This project will illustrate and advance methods for assessing the values of patients and stakeholders. It will demonstrate how CBPR methods apply to PCOR studies and the value of stated-preference methods in measuring the preferences of patients and stakeholders and directing health care.

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Key information

Conditions

Type II Diabetes Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Metabolic Diseases Nutritional and Metabolic Diseases Patient Preference Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

About this study

This study will apply the principles of CBPR to involve patients and stakeholders associated with a local community board and a national diabetes advisory board in key decisions in the project. During year 1, the investigators will utilize mixed methods to develop, pretest, and pilot the survey instruments to assess the preferences of patients with type II diabetes. In year 2, the investigators plan further engagement to finalize the survey instruments, and will implement a nationally representative, racially/ethnically diverse sample of patients with type II diabetes. Based on further consultation, the investigators will conduct statistical analysis, including stratified analyses and segmentation of patients with similar preferences. In year 3, mixed methods will be applied to assess beliefs of patients and other consumers about the relevance of this work and its generalizability to other PCOR topics. Finally, lay language reports will be developed to highlight patient and stakeholder engagement and the application of stated-preference methods to the study of the preferences of patients with type II diabetes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participate in the GfK's KnowledgePanel
  • Self-reported Type II diabetes diagnosis

Exclusion criteria

  • Does not have Type II diabetes diagnosis
  • Unable to communicate in English or Spanish

Treatment and study plan

Best-Worst Scaling (Case 2)

Other

Respondents receive questions asking them to choose the best and worst features of a hypothetical medication.

Discrete choice experiment

Other

Respondents receive questions asking them to choose the medication they prefer between a pair of hypothetical medications.

Primary outcomes

  1. Patient Medication Preference as Estimated by a Choice Model

    Time frame: One-time survey

    Preference estimate for each medicine attribute level from a conditional logit regression analysis. For each arm, there were six attributes of the medication, with 3 levels each. Within each attribute the parameter estimates for each of the levels sum to 0. If a parameter estimate for a level is above (below) 0 then the parameter is higher (lower) than average for that medication attribute.

  2. Weight Respondents Assign to Medication Attribute (Relative Attribute Importance) Assessed by a Choice Model

    Time frame: One-time survey

    Relative attribute importance (RAI) for each attribute in each arm measures the overall importance of that attribute. It is estimated by subtracting the lowest parameter estimate from the highest parameter estimate within each attribute. The RAI was then re-scaled on a 0 to 10 scale with 0 demonstrating no importance and 10 reflecting the most important attribute in each arm.

Secondary outcomes

  1. Self-reported Difficulty in Understanding and Answering the Survey Questions

    Time frame: One-time survey

    Questions that asked the respondents to evaluate if the Best-Worst Scaling (BWS) or Discrete Choice Experiment (DCE tasks were easy to understand and answer.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Advancing Stated-preference Methods for Measuring the Preferences of Patients With Type II Diabetes

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Dec 22, 2015
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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