METHODS: This is a prospective, single-centre, single-blind, randomised controlled pilot feasibility study: The Kegel Exercise Pregnancy Training app (KEPT-app) Trial. Sixty-four incontinent pregnant women who attended one primary care clinic for the antenatal follow-up will be recruited and randomly assigned to either intervention or waitlist control group. The intervention group will receive the intervention, the KEPT-app developed from the Capability, Opportunity, Motivation-Behaviour (COM-B) theory with Persuasive Technology and Technology Acceptance Model.
DISCUSSION: This study will provide a fine-tuning for our future randomised control study on the recruitment feasibility methods, acceptability, feasibility, and usability of the KEPT-app, and the methods to reduce the retention rates among pregnant women with UI.
TRIAL REGISTRATION: This study was registered on ClinicalTrials.gov on 19 February 2021 (NCT04762433) and is not yet recruiting.
METHODS: This was a cross-sectional study in a semi-urban primary care clinic in Selangor, Malaysia, among pregnant women aged 18 years old and above. The validated study instruments consisted of questions on socio-demography, the International Consultation on Incontinence Questionnaire-UI Short Form (ICIQ-UI SF) to determine UI and the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSQoL) to assess their QoL. A generalised linear model was used to determine the association between the continent and incontinent pregnant women with QoL.
RESULTS: Of the approached 610 respondents, 440 consented to participate in the study, resulting in a response rate of 72.1%. The mean age was 29.8 years old (SD 4.69) with 82.2% (n = 148) having stress UI. Significant independent factors related to the decreased QoL were mid to late trimester (OR 3.06, 95% CI 1.48-6.32), stress UI, (OR 6.94, 95%CI 4.00-12.04) and urge UI (OR3.87, 95%CI 0.48-31.28). Non-Malay improved QoL (OR 0.29, 95% CI 0.16-0.52).
CONCLUSIONS: All types of UI significantly affecting pregnant women's QoL. This information is useful in enhancing antenatal management at the primary care level, whereby they should be screened for UI and provided with effective early intervention to improve their QoL.
OBJECTIVE: This study aims to document the validation process in developing the Kegel Exercise Pregnancy Training app, which was designed to improve the PFMT adherence among pregnant women.
METHODS: We utilized an intervention mapping approach incorporated within the mobile health development and evaluation framework. The framework involved the following steps: (1) conceptualization, (2) formative research, (3) pretesting, (4) pilot testing, (5) randomized controlled trial, and (6) qualitative research. The user-centered design-11 checklist was used to evaluate the user-centeredness properties of the app.
RESULTS: A cross-sectional study was conducted to better understand PFMT and UI among 440 pregnant women. The study reported a UI prevalence of 40.9% (180/440), with less than half having good PFMT practice despite their good knowledge. Five focus group discussions were conducted to understand the app design preferred by pregnant women. They agreed a more straightforward design should be used for better app usability. From these findings, a prototype was designed and developed accordingly, and the process conformed to the user-centered design-11 (UCD-11) checklist. A PFMT app was developed based on the mHealth development and evaluation framework model, emphasizing higher user involvement in the application design and development. The application was expected to improve its usability, acceptability, and ease of use.
CONCLUSIONS: The Kegel Exercise Pregnancy Training app was validated using a thorough design and development process to ensure its effectiveness in evaluating the usability of the final prototype in our future randomized control trial study.
METHOD: Data collected for an individual participant data meta-analysis of Patient Health Questionnaire-9 (PHQ-9) diagnostic accuracy were analysed and binomial generalised linear mixed models were fit.
RESULTS: A total of 17 158 participants (2287 with major depression) from 57 primary studies were analysed. Among fully structured interviews, odds of major depression were higher for the MINI compared with the Composite International Diagnostic Interview (CIDI) (odds ratio (OR) = 2.10; 95% CI = 1.15-3.87). Compared with semi-structured interviews, fully structured interviews (MINI excluded) were non-significantly more likely to classify participants with low-level depressive symptoms (PHQ-9 scores ≤6) as having major depression (OR = 3.13; 95% CI = 0.98-10.00), similarly likely for moderate-level symptoms (PHQ-9 scores 7-15) (OR = 0.96; 95% CI = 0.56-1.66) and significantly less likely for high-level symptoms (PHQ-9 scores ≥16) (OR = 0.50; 95% CI = 0.26-0.97).
CONCLUSIONS: The MINI may identify more people as depressed than the CIDI, and semi-structured and fully structured interviews may not be interchangeable methods, but these results should be replicated.Declaration of interestDrs Jetté and Patten declare that they received a grant, outside the submitted work, from the Hotchkiss Brain Institute, which was jointly funded by the Institute and Pfizer. Pfizer was the original sponsor of the development of the PHQ-9, which is now in the public domain. Dr Chan is a steering committee member or consultant of Astra Zeneca, Bayer, Lilly, MSD and Pfizer. She has received sponsorships and honorarium for giving lectures and providing consultancy and her affiliated institution has received research grants from these companies. Dr Hegerl declares that within the past 3 years, he was an advisory board member for Lundbeck, Servier and Otsuka Pharma; a consultant for Bayer Pharma; and a speaker for Medice Arzneimittel, Novartis, and Roche Pharma, all outside the submitted work. Dr Inagaki declares that he has received grants from Novartis Pharma, lecture fees from Pfizer, Mochida, Shionogi, Sumitomo Dainippon Pharma, Daiichi-Sankyo, Meiji Seika and Takeda, and royalties from Nippon Hyoron Sha, Nanzando, Seiwa Shoten, Igaku-shoin and Technomics, all outside of the submitted work. Dr Yamada reports personal fees from Meiji Seika Pharma Co., Ltd., MSD K.K., Asahi Kasei Pharma Corporation, Seishin Shobo, Seiwa Shoten Co., Ltd., Igaku-shoin Ltd., Chugai Igakusha and Sentan Igakusha, all outside the submitted work. All other authors declare no competing interests. No funder had any role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; and decision to submit the manuscript for publication.