Premenstrual disorders Signs and Symptoms
Conditions
Interventions
The study is a user acceptability and usability study which will enable us to move on to validate the PreMentricS app.
The study will:
1. Determine numbers and power c
Sponsors
University of Alberta
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women from the general public between 18 -50 years age will be included in the study. We will be recruiting from the public as we intend to see which method of symptom recording is preferred in the general population (paper vs electronic method of data capture). The women recruited will be over the age of 18 years and under 50 years. Above 18 years is to ensure that recruited women have regular cycles and ovulation. The upper age limit exists as most women experience menopause around the age of 50 and we are studying disorders surrounding menstruation. 2. For the second part of the study: Qualified gynaecology doctors (male and female) will be recruited as they are specialists in the area and will have experience in being able to diagnose premenstrual disorders.
Exclusion criteria
Exclusion criteria: 1. Males 2. Women < 18 years of age 3. Pregnant women 4. Post menopausal women 5. Women on gonadotrophin releasing hormone analogues 6. Women who have used either method of symptom scoring previously 7. Women who lack capacity 8. Women who have special communication needs/who do not understand written English For the second part of the study: 1. Doctors (male or female) who are in training and not completed their qualifying exams (junior doctors in gynaecology)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to initiate the validation of the PreMentricS app against the current paper method of recording premenstrual symptoms, Daily Record of Severity of Problems (DRSP) charts. The current Royal College of Obstetricians and Gynaecologists Clinical Guideline on premenstrual disorders recognises the new PreMentricS app but also implies that it should be validated against the DRSP. Determination of the user (participant and clinician) acceptability and usability of PreMentricS app is the first step in this validation process. Acceptability will be measured using the affective attitude of the participants towards the methods (both women using the methods and clinicians using data collected by those methods) and the burden of the method on the participants. The data will be captured in the questionnaires which seek information on the participants' perception of the different methods. This will be analysed in the data analysis stage (Dec 2018 - Jan 2019). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Perceived concurrent validity measured from answers provided in the study questionnaires (completed by all participants - women using the methods and clinicians who will use those methods to make a diagnosis of premenstrual disorders). This will be measured in the data analysis stage (Dec 2018 - Jan 2019) 2. Construct validity of the app: concordance of the clinician's diagnosis with the diagnosis suggested by the app. Sensitivity, specificity, positive and negative predictive values will be assessed. This will be measured in the data analysis stage (Dec 2018 - Jan 2019) 3. Difference in proportion of days of prospective symptom recording completed between both methods. The app does not allow retrospective recording and women given the paper forms will be informed not to fill in information retrospectively. This will be measured in the data analysis stage (Dec 2018 - Jan 2019) 4. Proportion of women returning the paper forms and app results. This will be measured in the data analysis stage (Dec 2018 - Jan 2019) | — |
Countries
Australia, Canada, France, India, United Kingdom, United States of America
Outcome results
None listed