Natural Cycles app: contraceptive outcomes and demographic analysis of UK users

Pearson, Jack T; Chelstowska, Magda; Rowland, Simon P.; McIlwaine, Emily; Benhar, Eleonora; Scherwitzl, Elina Berglund; Walker, Susan; Danielsson, Kristina Gemzell; Scherwitzl, Raoul

doi:10.1080/13625187.2020.1867844

Cited by 13 publications

(8 citation statements)

References 19 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Two articles accounted for confounders but did not mention how they were chosen. Five articles used per-protocol analysis [ 32 , 39 , 41 , 43 , 44 ]. All articles had strong support for the SUTVA assumption and clear definitions of treatment and adherence.…”

Section: Resultsmentioning

confidence: 99%

Collection and Analysis of Adherence Information for Software as a Medical Device Clinical Trials: Systematic Review

Grayek,

Krishnamurti,

et al. 2023

JMIR Mhealth Uhealth

View full text Add to dashboard Cite

Background The rapid growth of digital health apps has necessitated new regulatory approaches to ensure compliance with safety and effectiveness standards. Nonadherence and heterogeneous user engagement with digital health apps can lead to trial estimates that overestimate or underestimate an app’s effectiveness. However, there are no current standards for how researchers should measure adherence or address the risk of bias imposed by nonadherence through efficacy analyses. Objective This systematic review aims to address 2 critical questions regarding clinical trials of software as a medical device (SaMD) apps: How well do researchers report adherence and engagement metrics for studies of effectiveness and efficacy? and What efficacy analyses do researchers use to account for nonadherence and how appropriate are their methods? Methods We searched the Food and Drug Administration’s registration database for registrations of repeated-use, patient-facing SaMD therapeutics. For each such registration, we searched ClinicalTrials.gov, company websites, and MEDLINE for the corresponding clinical trial and study articles through March 2022. Adherence and engagement data were summarized for each of the 24 identified articles, corresponding to 10 SaMD therapeutics. Each article was analyzed with a framework developed using the Cochrane risk-of-bias questions to estimate the potential effects of imperfect adherence on SaMD effectiveness. This review, funded by the Richard King Mellon Foundation, is registered on the Open Science Framework. Results We found that although most articles (23/24, 96%) reported collecting information about SaMD therapeutic engagement, of the 20 articles for apps with prescribed use, only 9 (45%) reported adherence information across all aspects of prescribed use: 15 (75%) reported metrics for the initiation of therapeutic use, 16 (80%) reported metrics reporting adherence between the initiation and discontinuation of the therapeutic (implementation), and 4 (20%) reported the discontinuation of the therapeutic (persistence). The articles varied in the reported metrics. For trials that reported adherence or engagement, there were 4 definitions of initiation, 8 definitions of implementation, and 4 definitions of persistence. All articles studying a therapeutic with a prescribed use reported effectiveness estimates that might have been affected by nonadherence; only a few (2/20, 10%) used methods appropriate to evaluate efficacy. Conclusions This review identifies 5 areas for improving future SaMD trials and studies: use consistent metrics for reporting adherence, use reliable adherence metrics, preregister analyses for observational studies, use less biased efficacy analysis methods, and fully report statistical methods and assumptions.

show abstract

Section: Resultsmentioning

confidence: 99%

Collection and Analysis of Adherence Information for Software as a Medical Device Clinical Trials: Systematic Review

Grayek,

Krishnamurti,

et al. 2023

JMIR Mhealth Uhealth

View full text Add to dashboard Cite

show abstract

“…This is in contrast with fundamental cause theory [31][32][33], stating that lower educated women experience more barriers in accessing reliable methods. We currently do not know why this is the case, but a possible explanation may be the variation within the group of women using natural or no contraception methods, as they include both women experience barriers to accessing contraceptives as 'typical' users of the app Natural Cycles being higher educated, financially comfortable women around the age of 30 who are in a stable/long term relationship [34][35][36]. This may be enforced by the selection effect of the Isala citizen-science project resulting in an over-representation of high SES women, since women were self-selected and likely already had an interest in health topics.…”

Section: Discussionmentioning

confidence: 99%

Relationship between classic indicators of health behaviour and contraceptive choices in women in Flanders

Van Eekert,

Biegel,

De Kort

et al. 2024

BMC Women's Health

View full text Add to dashboard Cite

Background In this study we shed light on ongoing trends in contraceptive use in Flanders (Belgium). Building on the fundamental cause theory and social diffusion of innovation theory, we examine socio-economic gradients in contraceptive use and the relationship to health behaviours. Methods Using the unique and recently collected (2020) ISALA data, we used multinomial logistic regression to model the uptake of contraceptives and its association to educational level and health behaviour (N:4316 women). Results Higher educated women, and women with a healthy lifestyle especially, tend to use non-hormonal contraceptives or perceived lower-dosage hormonal contraceptives that are still trustworthy from a medical point of view. Moreover, we identified a potentially vulnerable group in terms of health as our results indicate that women who do not engage in preventive health behaviours are more likely to use no, or no modern, contraceptive method. Discussion The fact that higher educated women and women with a healthy lifestyle are less likely to use hormonal contraceptive methods is in line with patient empowerment, as women no longer necessarily follow recommendations by healthcare professionals, and there is a growing demand for naturalness in Western societies. Conclusion The results of this study can therefore be used to inform policy makers and reproductive healthcare professionals, since up-to-date understanding of women’s contraceptive choices is clearly needed in order to develop effective strategies to prevent sexually transmitted infections and unplanned pregnancies, and in which women can take control over their sexuality and fertility in a comfortable and pleasurable way.

show abstract

“…There remains an unmet need for contraceptive choices, especially for non-hormonal methods. 29 FRFC is only available to those with smartphones, and, despite people of all ages having them, 30 the use of 'wearables' to monitor/control details of health is much more common in 18-to 34-year-olds. 31 The trend of using smartphones to manage health is here to stay as this generation gets older, as will FRFC.…”

Section: The Rise Of Digital Contraceptivesmentioning

confidence: 99%

Rethinking the regulation of digital contraception under the medical devices regime

McMillan

2023

Medical Law International

View full text Add to dashboard Cite

Contraceptives are vital healthcare for women and people with wombs. Recently, there has been a rise in the use of ‘digital contraceptives’, a type of ‘femtech’ software available for download on app stores which require data input in order to make predictions about users’ fertility. Digital contraceptives, when marketed as such, fall within the definition of a ‘medical device’ and under the authority of the Medical Devices Regulations 2002 are a ‘medium-risk’ device. However, not all femtech which may be used as contraception are captured by this framework. In this article, it is argued that the regulatory category into which digital contraceptives have been placed by the medical devices regime is (a) unduly limited in scope, (b) insufficiently stringent to protect users considering the grave and life-changing effects this technology can have if things go wrong, and (c) ill-conceived as a regulatory response to a technology that affects large sections of the population. It is suggested here that the broader context in which software as a contraceptive sits (i.e. within the general contraceptive market) is key to understanding the regulatory blindness that is occurring when it comes to digital contraceptives and some other forms of fertility-related femtech. As such, software which can be used as a contraceptive are in fact ‘high risk’ and should be reclassified as such.

show abstract

Natural Cycles app: contraceptive outcomes and demographic analysis of UK users

Cited by 13 publications

References 19 publications

Collection and Analysis of Adherence Information for Software as a Medical Device Clinical Trials: Systematic Review

Collection and Analysis of Adherence Information for Software as a Medical Device Clinical Trials: Systematic Review

Relationship between classic indicators of health behaviour and contraceptive choices in women in Flanders

Rethinking the regulation of digital contraception under the medical devices regime

Contact Info

Product

Resources

About