A digital health approach for identifying polyendocrine metabolic ovarian syndrome using machine learning and body temperature

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Machine learning models analyzing vaginal body temperature data from 387 users demonstrated moderate ability to predict Polyendocrine Metabolic Ovarian Syndrome, suggesting digital health devices could facilitate passive identification of this prevalent endocrine disorder.

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This study evaluated the feasibility of using machine learning models to identify Polyendocrine Metabolic Ovarian Syndrome (PMOS) based on basal body temperature data collected from a vaginal monitor. Researchers analyzed cycle-level and user-level temperature features from 387 participants, employing logistic regression, support vector machines, and random forest algorithms within a nested cross-validation framework. The results indicated moderate discrimination performance with area under the curve scores ranging from 0.64 to 0.70, suggesting that passive temperature monitoring could potentially aid in identifying undiagnosed cases. Relevance to endometriosis: The paper focuses on PMOS (formerly PCOS) and does not explicitly discuss endometriosis or adenomyosis; it was included in the corpus via a keyword match in the upstream search index.

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Abstract

Background Polyendocrine Metabolic Ovarian Syndrome (PMOS), formerly known as Polycystic Ovary Syndrome (PCOS), is a prevalent endocrine disorder with high rates of undiagnosed cases globally. Accessible screening tools are needed to facilitate appropriate management and earlier intervention. As PMOS is frequently characterised by oligo-anovulation, the absence of the characteristic rise in basal body temperature typically seen in ovulatory cycles may serve as a physiological marker for the condition. Objective This study aimed to assess the feasibility of using machine learning to identify individuals with PMOS from temperature data collected by a body-worn device. Methods We used data from 387 users of a vaginal temperature monitor (OvuSense TM ) who responded to a questionnaire. The sample was restricted to individuals with at least three cycles with sufficient temperature data and whose PMOS case/control status could be determined from questions about prior clinical consultation for infertility and conditions for which they take medications. We randomly sampled three menstrual cycles for each participant and derived a set of cycle-level and user-level temperature features. Cycle-level features included cycle length and measures describing the temperature rise indicative of ovulation (e.g. temperature rise, cycle day of temperature rise start). We also constructed a reference cycle representing the typical bi-phasic cycle pattern (created using cycles from those without known fertility conditions) and used this to derive features describing how much a participant’s cycles differed from this reference. The cycle-level features were aggregated into user-level features by taking the minimum, maximum, median, and range of the cycle-level features across the three selected cycles for each participant. We used 5-fold nested cross-validation to evaluate the extent that PMOS could be predicted, at the cycle and user levels, using Logistic Regression (LR), Support Vector Machine (SVM), and Random Forest (RF). Results The average age of participants was 31.97 years (SD=4.58), with 49.6% having a self-reported PMOS diagnosis. The models demonstrated moderate discrimination, with cycle-level AUC-ROC scores ranging from 0.64 (SD=0.02) (LR) to 0.68 (SD=0.04) (RF), and user-level scores ranging from 0.65 (SD=0.07) (LR) to 0.70 (SD=0.04) (RF). All models were reasonably calibrated, though confidence intervals were wide (e.g. RF cycle-level: calibration slope = 0.83 (95% confidence interval [CI]: 0.68, 1.00), calibration intercept = 0.02 (95% CI: -0.11, 0.14); user-level: slope = 0.88 (95% CI: 0.69, 1.15), intercept = -0.01 (95% CI: -0.22, 0.16)). Conclusions This study demonstrates the potential of using body temperature from digital health devices to identify those with PMOS. Such a passive approach to identifying PMOS could help to identify undiagnosed PMOS in those who have not actively sought a diagnosis. Further research is needed to assess its predictive performance and acceptability in a general population using more widely used digital devices.
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Abstract

Background Polyendocrine Metabolic Ovarian Syndrome (PMOS), formerly known as Polycystic Ovary Syndrome (PCOS), is a prevalent endocrine disorder with high rates of undiagnosed cases globally. Accessible screening tools are needed to facilitate appropriate management and earlier intervention. As PMOS is frequently characterised by oligo-anovulation, the absence of the characteristic rise in basal body temperature typically seen in ovulatory cycles may serve as a physiological marker for the condition.

Objective

This study aimed to assess the feasibility of using machine learning to identify individuals with PMOS from temperature data collected by a body-worn device.

Methods

We used data from 387 users of a vaginal temperature monitor (OvuSenseTM) who responded to a questionnaire. The sample was restricted to individuals with at least three cycles with sufficient temperature data and whose PMOS case/control status could be determined from questions about prior clinical consultation for infertility and conditions for which they take medications. We randomly sampled three menstrual cycles for each participant and derived a set of cycle-level and user-level temperature features. Cycle-level features included cycle length and measures describing the temperature rise indicative of ovulation (e.g. temperature rise, cycle day of temperature rise start). We also constructed a reference cycle representing the typical bi-phasic cycle pattern (created using cycles from those without known fertility conditions) and used this to derive features describing how much a participant’s cycles differed from this reference. The cycle-level features were aggregated into user-level features by taking the minimum, maximum, median, and range of the cycle-level features across the three selected cycles for each participant. We used 5-fold nested cross-validation to evaluate the extent that PMOS could be predicted, at the cycle and user levels, using Logistic Regression (LR), Support Vector Machine (SVM), and Random Forest (RF).

Results

The average age of participants was 31.97 years (SD=4.58), with 49.6% having a self-reported PMOS diagnosis. The models demonstrated moderate discrimination, with cycle-level AUC-ROC scores ranging from 0.64 (SD=0.02) (LR) to 0.68 (SD=0.04) (RF), and user-level scores ranging from 0.65 (SD=0.07) (LR) to 0.70 (SD=0.04) (RF). All models were reasonably calibrated, though confidence intervals were wide (e.g. RF cycle-level: calibration slope = 0.83 (95% confidence interval [CI]: 0.68, 1.00), calibration intercept = 0.02 (95% CI: -0.11, 0.14); user-level: slope = 0.88 (95% CI: 0.69, 1.15), intercept = -0.01 (95% CI: -0.22, 0.16)).

Conclusions

This study demonstrates the potential of using body temperature from digital health devices to identify those with PMOS. Such a passive approach to identifying PMOS could help to identify undiagnosed PMOS in those who have not actively sought a diagnosis. Further research is needed to assess its predictive performance and acceptability in a general population using more widely used digital devices. Competing Interest Statement ViO HealthTech Ltd provided the data used in this study and was involved in participant recruitment and data collection, but was not involved in the design, analysis, or execution of the research, and had no role in the decision to publish or in the preparation of the manuscript. TRG receives funding from Biogen, GSK and Roche for unrelated research. DAL and TRG receive funding from Novartis for unrelated research. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Faculty of Health Sciences Research Ethics Committee of University of Bristol gave ethical approval for this work (Reference: 4527). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data Availability The data used in study are not publicly available because they are owned by viO HealthTech. Abbreviations - AUC-ROC - Area under the receiver operating curve - BBT - Basal Body Temperature - CI - Confidence interval - CV - Cross-validation - DTW - Dynamic time warping - LR - Logistic regression - PCOS - Polycystic ovary syndrome - PMOS - Polyendocrine metabolic ovarian syndrome - RF - Random forest - SD - Standard deviation - SHAP - Shapley Additive exPlanations - SVM - Support Vector Machine

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