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Mobile health (mHealth) technologies have become increasingly popular for monitoring mental health symptoms and lifestyle behaviours, and are largely reported to be feasible and acceptable to users. However, to date, the efficacy of such technologies to improve perinatal mental health outcomes has been mixed. Within the perinatal context, much of this work has been done in the context of postpartum depression, stemming from electronic health records as well as cohort studies. There is, however, a dearth of studies focusing on depression in pregnancy, and machine learning-based clinical decision support systems remain underexplored. The HappyMums application has been developed to meet this need, and its use across Europe will be tested in this study.
A total of 1000 pregnant people currently suffering from, or at risk of, antenatal depression will be recruited across six countries. All participants will be between 13 and 28 weeks’ gestation and will be given access to the new purposefully developed HappyMums mobile application, to use from enrolment until 2 months postpartum. The application leverages passively collected data from smartphone sensors relating to physical activity and behaviour, as well as requiring active engagement from the user to complete mental health questionnaires and ‘game-like’ activities. Digital data types will be combined with traditional mental health measurement methods, such as standardised questionnaires and interviews, to develop novel predictive models capable of identifying mental health trajectories in women at risk of developing antenatal depression and to test the app’s utility for use as personalised risk prediction and depression identification tool. The primary outcome of this study is to determine what proportion of users will continue to use the mobile application and engage with its tasks and activities at least weekly, while secondary exploratory outcomes include assessing usability of the app and testing the predictive ability of a novel machine learning-based model. These outcomes will, for the first time, be assessed by integrating active as well as passive data.
Ethical approval has been granted by local research ethics committees in each recruiting centre. At King’s College London (leading the clinical study), the study was reviewed by the East of England—Essex Research Ethics Committee and granted favourable opinion (REC reference 24/EE/0129). All other sites collecting participant data have the study approved for local delivery. Findings relating to the primary and secondary outcomes will be submitted for publication in open access, peer-reviewed journals, as well as presentations at conferences as symposia or posters. Findings will be made available to a non-specialist audience through open access digital mental health magazines and promotion on social media.
To adapt and validate the HSOPS 2 instrument for the Italian context and to describe the current patient safety culture amongst healthcare personnel working in Italian hospitals.
Cross-sectional study.
We adapted and validated the HSOPS 2 instrument following the COSMIN guidelines: we performed a forward-backward translation, calculated the content validity index, evaluated face validity, acceptability (percentage of participants responding to all items on the questionnaire and to every specific item), construct validity (confirmatory factor analysis), and internal consistency (Cronbach's alpha for each dimension). We then performed a cross-sectional study following the guidelines of the original instrument: we categorised the responses into “positive,” “negative,” and “midpoints.” For each dimension we calculated the average percentage of positive responses. We repeated this process, dividing the responses by various sample characteristics (e.g., profession), and compared them using the chi-square test. Data were collected between April and November 2023.
A total of 633 hospital personnel participated in the survey, and 473 completed the questionnaire in its entirety. The dimensions of “teamwork”, “supervisor”, “manager”, or “clinical leader support”, and “communication about error” emerged as dimensions with higher percentages of positive responses, while those that received lower percentages were “hospital management support for patient safety”, “staffing and work pace”, and “response to error”. We identified statistically significant differences in many dimensions between gender, profession, and clinical inpatient units.
These findings provide a comprehensive overview of challenges and opportunities within the healthcare sector as regards patient safety culture and can inform the development of targeted interventions aimed at improving patient safety across healthcare organisations.
Proper assessment of safety culture, one of the main indicators of patient safety, can inform the development of effective strategies and interventions to enhance patient safety.
What problem did the study address? To effectively assess patient safety culture, it is essential to use valid and reliable tools. It is crucial to proactively assess patient safety culture in hospital personnel, whether employed in clinical units, in management, or in support services, to develop initiatives aimed at improving patient safety.
What were the main findings? The use of the adapted and validated version of the HSOPS 2 will produce valid and reliable evidence on patient safety culture. Perception of patient safety culture differs amongst respondents according to gender, profession, clinical setting. The dimensions of “hospital management support for patient safety”, “staffing and work pace”, and “response to error” were identified as those with the greatest need for improvement.
Where and on whom will the research have an impact? Patient safety heavily impacts care at every level; therefore, this study could have an impact on healthcare organisations as well as healthcare workers, patients, and their families. By making available an instrument that can contribute to a proper assessment of patient safety culture, this study might contribute to the development of appropriate strategies and targeted interventions to improve patient safety, quality of care and satisfaction while decreasing adverse events and related costs.
The COSMIN guidelines were used for the validation of the instrument; the STROBE reporting guidelines were used for the cross-sectional study.
No patient or public contribution.
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