Comparison of Different Frames of Numerical Information in Cochrane Plain Language Summaries

Health Knowledge, Attitudes, Practice Clinical Trial

Official title:

Comparison of Different Frames of Numerical Information in Cochrane Plain Language: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03554252
• Other study ID #: 214-09-7672
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: August 1, 2018

Study information

• Verified date: May 2018
• Source: University of Split, School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Participants will be randomly given one of two formats containing descriptions of health interventions. In one format, participants will have to read short summaries where results of the intervention are presented as frequencies and the side effects of health intervention are presented as percentages, while in another format the frames will be reversed (results will be presented as percentages and side effects as frequencies). After reading, participants will be asked several questions about the content of the summary and its conclusions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients who are visiting their family doctor, and are at least 18 old. Students of biomedical studies at University of Split School of Medicine, who are at least 18 years old.

Exclusion Criteria:

• Participants younger than 18 years.

Related Conditions & MeSH terms

• Health Knowledge, Attitudes, Practice

Intervention

Other:
• Frequencies
Results are presented as natural frequencies (e.g. the drug was effective for 1 out of 10 people) while side effects are presented as percentages (e.g. 40% participants experienced severe side effects)
• Percentages
Results are presented as percentages (e.g. the drug was effective for 10% of people) while side effects are presented as natural frequencies (e.g. 4 out of 10 participants experienced severe side effects)

Locations

Country	Name	City	State
Croatia	University of Split School of Medicine	Split

Sponsors (1)

Lead Sponsor	Collaborator
University of Split, School of Medicine

Country where clinical trial is conducted

Croatia, 

References & Publications (1)

Schapira MM, Walker CM, Cappaert KJ, Ganschow PS, Fletcher KE, McGinley EL, Del Pozo S, Schauer C, Tarima S, Jacobs EA. The numeracy understanding in medicine instrument: a measure of health numeracy developed using item response theory. Med Decis Making. 2012 Nov-Dec;32(6):851-65. doi: 10.1177/0272989X12447239. Epub 2012 May 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Understanding	Number of the correct answers about the content of the summary, which will consist of four multiple choice questions (with four possible answers where only one is correct, for each question) about the text the participants are reading. Questions will be developed by research team and revised by expert in health communication. The scale ranges from 0-4, where greater score indicates better understanding of the material.	3 months
Secondary	Attitudes towards the appropriateness of this type of presentation of health information	Likert type scale from 1-10 (1 indicating low appropriateness and 10 would be completely appropriate presentation)	3 months
Secondary	Health numeracy	5 questions about the numerical tasks placed in medical content, total score is number of correct answers on those questions. The five questions are part of Numeracy Understanding in Medicine Instrument (Schapira et al, 2012), and we will translate only the questions focusing on Probability section. Cronbach's alpha in previous research was 0.86 (Schapira et al, 2012). The questions will be revised by independent translator and back translated to English. The scale range is from 0-5, where higher score indicates higher numeracy levels.	3 months