Psychometric properties of an instrument for assessing treatment satisfaction associated with pramlintide use

Richard R. Rubin, Mark Peyrot

Research output: Contribution to journalArticle

Abstract

Background: The clinical benefits of any new treatment depend substantially on patient acceptance and treatment satisfaction, because only well-accepted treatments will be widely used. Thus, it is important to understand how patients experience a new treatment. Objective: This study assessed the psychometric properties of a questionnaire (PRAM-TSQ) designed to measure treatment satisfaction in patients using pramlintide (an analog of amylin, a glucoregulatory hormone co-secreted with insulin), which is designed to improve glucose control. Methods: Patients with diabetes completed the 14-item PRAM-TSQ at the end of 2 separate lacebo-controlled, double-blind, randomized clinical trials in which they added active or placebo pramlintide to their established insulin regimen. Factor analysis was used to assess item clustering for the PRAM-TSQ, and the Cronbach's α measure of inter-item agreement was used to assess scale reliability. PRAM-TSQ validity was assessed by comparing scores between treatment arms, and effect sizes were measured by the n statistic. Validity was also assessed by associations (Pearson correlations) between the PRAM-TSQ and clinical study outcomes (end of study values and during study changes in clinical measures: postprandial glucose [PPG], A1C, weight, and insulin requirements). Results: Scaling revealed 4 PRAM-TSQ components: Global Benefits, Specific Benefits, Absence of Side Effects, Treatment Preference. The total composite PRAM-TSQ had good reliability in both studies (type 1 α =.93; type 2 α =.94); subscale reliabilities ranged from.65 to 94. Composite scores differed for pramlintide-treated and placebo-treated patients (type 1 P

Original languageEnglish (US)
Pages (from-to)136-146
Number of pages11
JournalDiabetes Educator
Volume35
Issue number1
DOIs
StatePublished - Jan 2009
Externally publishedYes

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Psychometrics
Insulin
Therapeutics
Placebos
Islet Amyloid Polypeptide
Glucose
pramlintide
Patient Satisfaction
Statistical Factor Analysis
Cluster Analysis
Randomized Controlled Trials
Outcome Assessment (Health Care)
Hormones
Weights and Measures

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Health Professions (miscellaneous)

Cite this

Psychometric properties of an instrument for assessing treatment satisfaction associated with pramlintide use. / Rubin, Richard R.; Peyrot, Mark.

In: Diabetes Educator, Vol. 35, No. 1, 01.2009, p. 136-146.

Research output: Contribution to journalArticle

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