None listed
Conditions
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.
Interventions
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
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”.
Sponsors
School of Public Health, University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Female and fluent in written English.
Exclusion criteria
Male and not fluent in written English.
Outcome results
None listed