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Trial registered on ANZCTR


Registration number
ACTRN12617000111370
Ethics application status
Approved
Date submitted
18/01/2017
Date registered
20/01/2017
Date last updated
20/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Influence of the Disease Label 'Polycystic Ovary Syndrome' on Intention to have an Ultrasound and Psychosocial Outcomes: A Randomised Online Study in Young Women
Scientific title
Influence of the Disease Label 'Polycystic Ovary Syndrome' on Intention to have an Ultrasound and Psychosocial Outcomes: A Randomised Online Study in Young Women
Secondary ID [1] 290930 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The effect of the disease label 'Polycystic Ovary Syndrome' 301653 0
Condition category
Condition code
Mental Health 301368 301368 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 301405 301405 0 0
Health promotion/education
Reproductive Health and Childbirth 301417 301417 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is delivered online and takes approximately 15-30 minutes to complete.

Time 1 intervention: Hypothetical scenarios are used to test the impact of the disease label 'polycystic ovary syndrome' on outcome measures. The text scenarios are presented online using Qualtrics survey software.

Intervention materials: A hypothetical scenario of a doctor’s visit- Participants are asked to imagine that for the past six months they have had unusually irregular periods, a few more pimples than usual and an increase of body hair in certain areas, so they visit their general practitioner to see if this is of any concern.

Disease label intervention: In the intervention group, the doctor provides the disease label ‘polycystic ovary syndrome’ for the symptoms described. The control group receives no disease label (symptoms are just described as an hormonal imbalance)
Information about ultrasounds variable: the doctor briefly mentions that ultrasounds are unreliable in clarifying a diagnosis or identifying the cause of absent periods vs. the doctor mentions no information about ultrasound unreliability.

Participants are randomised to receive one of four hypothetical scenarios, where the disease label provided and information about ultrasounds given is varied:
1) PCOS disease label + no information about ultrasound reliability
2) No disease label + no information about ultrasound reliability
3) PCOS disease label + information about ultrasound reliability
4) No disease label + information about ultrasound reliability

Time 2 intervention: Second hypothetical scenario highlighting issue of overdiagnosis of PCOS.
After completing the outcome measures after viewing the first hypothetical scenario, all participants are presented with another scenario asking them to imagine they get a second opinion. In this second scenario, the new doctor says: “I believe your symptoms are often overdiagnosed as polycystic ovary syndrome. Because of the increased sensitivity of ultrasounds, screening can lead to finding ‘abnormalities’ that are not harmful or unusual, resulting in unnecessary stress, anxiety and medication”.
Intervention code [1] 296881 0
Behaviour
Comparator / control treatment
The control group is provided the same explanation and summary of associated risks in the hypothetical scenario of a doctor's visit, but does not receive a specific disease label for their hypothetical condition, the doctor instead referring to the condition as a ‘hormonal imbalance’ throughout the scenario. The words 'polycystic ovary syndrome' are never mentioned prior to post-intervention measures or during the hypothetical scenario.
Control group
Active

Outcomes
Primary outcome [1] 300764 0
Intention to have an ultrasound: a single item on a 10-point scale assessing hypothetical intention to have an ultrasound, adapted from previous research (Fisher et al., 2012) (1=Definitely will not to 10=Definitely will).
Timepoint [1] 300764 0
Immediately after participants have read their respective hypothetical scenarios of the doctors visit at Time 1.
Secondary outcome [1] 330813 0
Self-esteem, measured using the validated Rosenberg self-esteem scale (Strongly disagree to Strongly agree) (Rosenberg, 1965).
Timepoint [1] 330813 0
Immediately after participants have read their respective hypothetical scenarios of the doctors visit at Time 1.
Secondary outcome [2] 330904 0
Negative affect, measured using the validated Positive and Negative affect schedule (PANAS) questionnaire, which consists of 20 items that each describe a mood, measured on a 5-point scale (Very slightly or not at all to Extremely) (Watson et al., 1988).
Timepoint [2] 330904 0
Immediately after participants have read their respective hypothetical scenarios of the doctors visit at Time 1.
Secondary outcome [3] 330905 0
Perceived severity of the (hypothetical) diagnosis:
The validated Perceived Severity Scale, which measured 5 items on a 5-point scale (Strongly disagree to Strongly agree) (Bish, 2000).

Timepoint [3] 330905 0
Immediately after participants have read their respective hypothetical scenarios of the doctors visit at Time 1.
Secondary outcome [4] 330906 0
Intention to have an ultrasound, after information about overdiagnosis is presented, measured by a single item on a 10-point scale, adapted from previous research (Fisher et al., 2012) (1=Definitely will not to 10=Definitely will).
Timepoint [4] 330906 0
Measured immediately after participants are presented with the second hypothetical scenario, where a second doctor mentions the possibility of overdiagnosis of PCOS at Time 2.
Secondary outcome [5] 330907 0
Perceived seriousness was measured using a single item on a 7-point scale (Strongly disagree to Strongly agree) (Courneya, 2001).
Timepoint [5] 330907 0
Immediately after participants have read their respective hypothetical scenarios of the doctors visit at Time 1.
Secondary outcome [6] 330908 0
Perceived seriousness of diagnosis, after information about overdiagnosis is presented, measured using a single item on a 7-point scale (Strongly disagree to Strongly agree).
Timepoint [6] 330908 0
Measured immediately after participants are presented with the second hypothetical scenario, where a second doctor mentions the possibility of overdiagnosis of PCOS at Time 2.
Secondary outcome [7] 330909 0
Credibility of the doctor, measured using the validated five item Credibility Index, measured on a 5-point scale (Longman et al., 2012, Meyer, 1988).
Timepoint [7] 330909 0
Immediately after participants have read their respective hypothetical scenarios of the doctors visit at Time 1.
Secondary outcome [8] 330910 0
Interest in obtaining a second opinion: One item on a 7-point scale.
Timepoint [8] 330910 0
Immediately after participants have read their respective hypothetical scenarios of the doctors visit at Time 1.
Secondary outcome [9] 330911 0
Response efficacy of having the ultrasound: 4 items on a 7-point scale, adapted from previous research (Courneya & Hellsten)
Timepoint [9] 330911 0
Immediately after participants have read their respective hypothetical scenarios of the doctors visit at Time 1.
Secondary outcome [10] 330928 0
Response costs of having the ultrasound (4 items on a 7-point scale; Courneya & Hellsten, 2001).
Timepoint [10] 330928 0
Immediately after participants have read their respective hypothetical scenarios of the doctors visit at Time 1.

Eligibility
Key inclusion criteria
Female and fluent in written English.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Male and not fluent in written English.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants were sent an email link to access the Qualtrics survey by the researcher. The link directed participants to complete the online consent form. After completing the consent form participants were then randomised to one of the four hypothetical scenarios using Qualtrics survey software. The recruiting researcher was unaware of which condition participants would be randomised to, as randomisation occurred after participants had clicked on the link to complete the online intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using Qualtrics survey software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical Package for the Social Sciences (SPSS) version 22.0 was used, with an alpha level of .05 set for all statistical tests. A power analysis using Cohen's d formula was conducted, and results indicated a sample size of N = 160 was sufficient to detect a medium effect size (f=.30) with power at .95 and significance level of .05. However, to be able to detect effects in the secondary outcomes it is worthwhile recruiting more participants.

To control for previous experience of the syndrome and its associated symptoms, a composite variable was computed by combining a personal diagnosis and/ or a family history of PCOS to include as a covariate in further analyses. Prior to analyses, data was examined for missing values, outliers and accuracy, and to establish homogeneity of variance. A few outliers were identified, however, as they had no effect on results, they were retained to provide a complete report of the data.

To analyse the effect of the disease label and ultrasound reliability information on participants’ intention and psychosocial outcomes, six 2 (disease label: PCOS versus no label) x2 (ultrasound reliability: unreliable versus no information) between-participant analyses of covariance (ANCOVAS), were conducted, controlling for previous history of PCOS (personal diagnosis and/or family history). Two 2x2x(2) mixed-design ANCOVAS were also conducted to investigate the impact of the two experimental factors on intention and perceived severity after overdiagnosis information was presented.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/06/2015
Date of last participant enrolment
Anticipated
Actual
24/08/2015
Date of last data collection
Anticipated
Actual
31/08/2015
Sample size
Target
160
Accrual to date
Final
204
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 15110 0
2006 - The University Of Sydney

Funding & Sponsors
Funding source category [1] 295360 0
Government body
Name [1] 295360 0
National Health and Medical Research Council Program Grant 633003
Country [1] 295360 0
Australia
Primary sponsor type
University
Name
School of Public Health, University of Sydney
Address
Edward Ford Building (A27)
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 294187 0
None
Name [1] 294187 0
Address [1] 294187 0
Country [1] 294187 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296693 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 296693 0
Human Ethics Office
Margaret Telfer Building (K07)
University of Sydney
NSW 2006
Ethics committee country [1] 296693 0
Australia
Date submitted for ethics approval [1] 296693 0
13/04/2015
Approval date [1] 296693 0
29/05/2015
Ethics approval number [1] 296693 0
2015/335

Summary
Brief summary
Widening diagnostic criteria and improved imaging sensitivity have increased the number of reproductive-aged women diagnosed with PCOS from 4-8% to up to 21%. Given the increase in prevalence, the uncertain clinical benefit of knowing this diagnosis needs to be weighed against the potential for poor psychological outcomes in women labelled with PCOS. The purpose of this experimental study was to investigate the impact of the disease label PCOS on interest in medical interventions and on psychosocial outcomes.
181 young women were randomised online to receive one of four hypothetical scenarios of a doctor’s visit in a 2 (PCOS disease label vs. no disease label) x 2 (information about unreliability of ultrasounds in clarifying diagnosis vs. no information) design. Participants were university students (mean age: 19.4). After presenting the scenario, intention to have an ultrasound, negative affect, self-esteem, perceived severity of condition, credibility of the doctor, interest in a second opinion and response efficacy and costs of having the ultrasound were measured. Participants were then presented with a second scenario, where the possibility of PCOS overdiagnosis was mentioned. Change in intention and perceived severity were then assessed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71762 0
Dr Jesse Jansen
Address 71762 0
226a Edward Ford Building (A27)
The University of Sydney
NSW 2006
Country 71762 0
Australia
Phone 71762 0
+61 02 9351 5178
Fax 71762 0
Email 71762 0
[email protected]
Contact person for public queries
Name 71763 0
Dr Jesse Jansen
Address 71763 0
226a Edward Ford Building (A27)
The University of Sydney
NSW 2006
Country 71763 0
Australia
Phone 71763 0
+61 02 9351 5178
Fax 71763 0
Email 71763 0
[email protected]
Contact person for scientific queries
Name 71764 0
Dr Jesse Jansen
Address 71764 0
226a Edward Ford Building (A27)
The University of Sydney
NSW 2006
Country 71764 0
Australia
Phone 71764 0
+61 02 9351 5178
Fax 71764 0
Email 71764 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseInfluence of the disease label polycystic ovary syndrome' on intention to have an ultrasound and psychosocial outcomes: A randomised online study in young women.2017https://dx.doi.org/10.1093/humrep/dex029
N.B. These documents automatically identified may not have been verified by the study sponsor.