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

• ClinicalTrials.gov Identifier: NCT03554252
• Recruitment Status: Completed
• First Posted: June 13, 2018
• Last Update Posted: September 25, 2018
• Sponsor: University of Split, School of Medicine
• Information provided by (Responsible Party): University of Split, School of Medicine

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Health Knowledge, Attitudes, Practice	Other: Frequencies; Other: Percentages	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 225 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: Comparison of Different Frames of Numerical Information in Cochrane Plain Language: Randomized Controlled Trial
• Actual Study Start Date: April 1, 2018
• Actual Primary Completion Date: August 1, 2018
• Actual Study Completion Date: August 1, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Frequencies	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)
Experimental: Percentages	Other: 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)

Outcome Measures

Primary Outcome Measures :

1. Understanding [ Time Frame: 3 months ]
   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.

Secondary Outcome Measures :

1. Attitudes towards the appropriateness of this type of presentation of health information [ Time Frame: 3 months ]
   Likert type scale from 1-10 (1 indicating low appropriateness and 10 would be completely appropriate presentation)
2. Health numeracy [ Time Frame: 3 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Croatia

University of Split School of Medicine

Split, Croatia, 21000

Sponsors and Collaborators

University of Split, School of Medicine

Investigators

• Principal Investigator: Ivan Buljan, MPsy; PhD student

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Buljan I, Tokalić R, Roguljić M, Zakarija-Grković I, Vrdoljak D, Milić P, Puljak L, Marušić A. Framing the numerical findings of Cochrane plain language summaries: two randomized controlled trials. BMC Med Res Methodol. 2020 May 6;20(1):101. doi: 10.1186/s12874-020-00990-4.

• Responsible Party: University of Split, School of Medicine
• ClinicalTrials.gov Identifier: NCT03554252
• Other Study ID Numbers: 214-09-7672
• First Posted: June 13, 2018
• Last Update Posted: September 25, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No