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OBJECTIVES: Pre-trial acceptability studies may boost recruitment, especially in trials comparing distinctly different interventions. We evaluated the impact of an acceptability study on recruitment to a randomised trial of antipsychotic reduction versus maintenance treatment and explored demographic and clinical predictors of subsequent enrolment. METHODS: Participants with a diagnosis of a schizophrenia spectrum disorder who were taking antipsychotic medication were interviewed about their views of taking part in a future trial. RESULTS: In a sample of 210 participants, 151 (71.9%) expressed an interest in taking part in the future trial, 16 (7.6%) said they might be interested, and 43 (20.5%) said they were not. Altruistic reasons were most commonly given for wanting to take part, and concern about randomisation for not wanting to. Ultimately 57 people enrolled in the trial (27.1% of the original sample). Eighty-five people who initially expressed an interest did not enrol due to declining or not being eligible (for clinical reasons). Women and people from a white ethnic background were more likely to enrol in the trial, but no illness or treatment-related characteristics were associated with enrolment. CONCLUSION: An acceptability study can be a useful tool for recruitment to challenging trials, but it may over-estimate recruitment.

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The objective of this study was to determine the attitudes and impressions of breastfeeding mothers and healthcare practitioners towards a device concept integrating breastfeeding with infant drug and nutrient administration. This was an exploratory qualitative study involving 20 breastfeeding mothers and 6 healthcare practitioners from the Suffolk and Middlesex County areas of Massachusetts, USA each individually interviewed. Interview transcription of the semi-structured interviews by an independent service began during data collection, and data coding into major themes continued until and after data saturation was reached. Repeated medication delivery with a reusable product was highlighted as a potential use case for the device concept; ease of use and cleaning as well as cost, familiarity with the method, and infant response were identified as critical considerations. Participants questioned device suitability with liquid formulations (as opposed to non-liquid), while potential advantages over alternative medication delivery technology like oral syringes were identified, including a more "natural" feeling. Most participants had prior knowledge of, or personal experience with, devices like commercially available nipple shields. Attitudes towards the NSDS were not determined by experience with nipple shields, however. The participants' prior exposure to nipple shields is in contrast to related studies in Kenya and South Africa where commercial nipple shields were not widely known and where specific concerns surrounding potential community stigma to an unknown device were raised by participants.

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Purpose: Transgender and gender-nonconforming (TGNC) youth often report higher rates of chronic social stressors such as victimization, discrimination, and rejection. Some of these gender-based stressors may have long-range physical health consequences through inflammation pathways. This study evaluates the feasibility and acceptability of adding biological measures of inflammation to an ongoing prospective clinical study of TGNC youth (ages 9-20 years), initiating affirming medical therapy at a large, urban children's hospital (N=56). We also examine the relationship between gender-based sources of stress and support with inflammation. This is the first study to explore how gender identity, social stressors, and social supports may contribute to poorer health in TGNC youth through inflammation and immune dysregulation pathways. Methods: Between October 2016 and August 2018, the study team collected dried blood spot (DBS) samples and health measures during clinical visits. Participants also completed computer-assisted surveys assessing gender minority stress and support during these visits. We used regression analysis to evaluate differences in C-reactive protein (CRP) controlling for demographics, health, gender-based stress, and supports. Results: The results from this study indicate that adding DBS samples to assess inflammation was feasible and acceptable in a clinical sample of TGNC youth seeking affirming-medical interventions. We found an association between greater inflammation and the composite score for greater gender-based stressors and lower gender-based supports using the Gender Minority Stress and Resilience Tool (GMSR); however, we did not find statistically significant differences in CRP associated with any of the individual GMSR subscales assessing various types of gender-based supports or stressors. Conclusion: More research is necessary to evaluate how different sources of gender-based support and stress relate to inflammation with larger sample sizes.

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BACKGROUND: Transgender people are at a high risk of suicidal ideation, suicide attempts, and deaths. Among transgender individuals, 77% and 41% engage in suicidal ideation and suicide attempt in their lifetime, respectively, which exceeds the general population rates (9.2% and 2.7%, respectively). Traditionally, suicide risk factors have been studied over a long period between measurements, making it difficult to understand the short-term variability in suicide risk. Mobile phone apps offer an opportunity to understand the immediate precursors of suicidality through the assessment of behaviors and moods in real time. This is the first study to use a mobile phone app (TransLife) to understand the short-term risk factors for suicide among transgender individuals. OBJECTIVE: This study aims to beta test the usability of an evidence-informed mobile health (mHealth) suicide prevention phone app, TransLife. The primary aims are to obtain preliminary data on user engagement and satisfaction with the app, and to assess the feasibility of completing ecological momentary assessments (mood logs) within the app. METHODS: We used qualitative methods and an exploratory research approach that combined naturalistic app use, focus groups, and semistructured phone interviews. The focus group was informed about the development of the prototype. We conducted a 3-week evaluation to determine engagement and obtain detailed user feedback about the app. After participation in the pilot, phone-based, semistructured, and audio-recorded exit interviews were conducted with the research participants. RESULTS: In total, 16 transgender individuals participated in this study. On average, users logged in 4 (SD 2.7) times a week and spent approximately 5 (SD 3.5) minutes on the app per log-in. A total of 6 major themes emerged in this study. These themes focused on the app's functionality, satisfaction with using the app, perceived ease of use, perceived safety of providing personal data within the app, trusting the app enough to share personal feelings, and features that make this app engaging. These themes suggest that TransLife is an engaging, useful, and acceptable mHealth intervention. Participants reported that the app was easy to use and understand, supported mental self-care, promoted self-awareness, and helped them identify triggers of negative moods. CONCLUSIONS: The results of this pilot study indicate that TransLife is an engaging, acceptable, and potentially effective mHealth intervention. Transgender participants reported many advantages of using TransLife, such as being able to track their mood, connecting to the community, and accessing local resources. This study provides initial support for the acceptability and usability of TransLife as an mHealth intervention designed for the transgender community.

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PURPOSE: In France, polypharmacy among older people living in nursing homes (NH) is a major public health concern. In this context, the randomized controlled trial TEM-EHPAD was recently launched in various NH in southern France to evaluate the impact of implementing a novel telemedication review (TMR) on hospital admission rates of NH residents at high risk of iatrogenic disease. A qualitative study was integrated into the main trial study to assess general practitioners' (GP) and other NH healthcare professionals' (HP) acceptability of the proposed TMR before its implementation. MATERIAL AND METHODS: A qualitative study using face-to-face semi-structured interviews was conducted with 16 HP before the beginning of the intervention. A manual thematic analysis was performed on the transcribed interviews. RESULTS: Four main themes emerged from the thematic analysis: HP perceptions of the TMR, difficulties related to medication management for NH residents, HP perceptions of the roles of different professionals, and facilitators of good practices. Most participants were favorable to the TMR, but some GP expressed fears about loss of control over their prescription writing. CONCLUSION: This study fulfilled its objective to assess pre-intervention acceptability by GP and other HP. Results provided important information about how to adapt the TMR intervention to make it more acceptable to HP who will be involved in TEM-EHPAD. One of the main recommendations is the importance of providing participating GP with the opportunity to take part in the process of reviewing prescriptions.

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OBJECTIVE: To gain insights from pregnant women and obstetricians on the utility of the FIGO Nutrition Checklist in antenatal practice. METHODS: Women were recruited from the antenatal department of a large tertiary-level university maternity hospital in Dublin, Ireland, between October and December 2019. Participants completed the FIGO Nutrition Checklist before their routine antenatal appointment. Obstetricians and women were encouraged to discuss the FIGO Nutrition Checklist during the clinical visit. Completed FIGO Nutrition Checklists were collected after appointments. Acceptability was assessed through questionnaires. RESULTS: The majority (80.0%) of women answered "No" to at least one diet quality question, indicating a potential nutritional risk. While none of the participating obstetricians routinely discussed nutrition with women, all agreed that using the Checklist encouraged them to address nutrition with pregnant women. Nearly every woman (99.0%) found the Checklist quick to complete; however, all participating obstetricians felt there was not enough time to discuss it in routine practice. Despite this, most obstetricians and pregnant women recommended the FIGO Nutrition Checklist for use. CONCLUSION: The FIGO Nutrition Checklist is acceptable for use in routine antenatal practice in tertiary care settings. It helped identify potentially at-risk women during early pregnancy and facilitated conversations related to optimum diet.

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OBJECTIVE: To gain an in-depth understanding of how the FIGO Nutrition Checklist could work in clinical practice, from the perspective of pregnant women. METHODS: This qualitative study was part of a pilot study of the FIGO Nutrition Checklist in the antenatal department of a tertiary-level university maternity hospital in Dublin, Ireland. Individual semistructured phone interviews were conducted with pregnant women who had completed the FIGO Nutrition Checklist as part of the pilot. Interviews were transcribed verbatim and analyzed using content analysis after manual coding of transcripts. Themes and subthemes are described. RESULTS: Ten interviews were completed. Subthemes related to the FIGO Nutrition Checklist emerged including ease of use and comprehension. Participants discussed how the tool could add value to their appointment by supporting initiation of nutrition conversations and highlighting nutritional issues. The first trimester was identified as the highest priority for using the FIGO Nutrition Checklist. The convenience of having nutrition addressed as part of standard care, rather than a separate appointment, also emerged. CONCLUSION: Women in this study had a desire for nutrition and weight to be addressed by clinicians during routine antenatal appointments. The findings support using the FIGO Nutrition Checklist to address this.

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When developing an innovative intervention, its acceptability to patients, health care professionals and managers must be considered to ensure the implementation into practice. This study aims to identify factors influencing the acceptability of a computer-tailored and pedometer-based socio-cognitive intervention for patients with heart disease. Focus group interviews were conducted in two outlying regions of the province of Quebec (Canada). The Theory of Planned Behavior formed the theoretical basis of the interview guide. Two researchers performed verbatim analysis independently until consensus was achieved. The sample included 44 participants divided into six groups (patients n = 7 + 8, health care professionals n = 8 + 8, managers n = 6 + 7). Health care professionals and managers mentioned benefits concerning partners' opportunity to improve assessment and monitoring. Patients believed the intervention could be useful to improve adherence to physical activity. Additional benefits indicated were self-monitoring behavior and improved health-related outcomes. However, patients expressed concern about the online security, fearing possible data breach. Some clinicians felt the pedometer may not be able to evaluate physical activities other than walking. With regard to behavioral control, a web application and pedometer must be easy to use and compatible with services already in place. Further barriers include level of literacy, cost and the various difficulties associated with wearing a pedometer. Findings suggest that, to improve the acceptability of a computer-tailored and pedometer-based socio-cognitive intervention, users must be assured of a secure website, validated, affordable and easy-to-use pedometers, and an intervention adapted to their level of literacy.

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BACKGROUND: Topical cosmetic products can cause adverse reactions in some individuals, particularly those with sensitive skin who may develop irritations or allergic contact dermatitis. Evidence suggests that the frequency of self-reported sensitive skin is increasing in the general population, placing greater importance on clinical testing of topical cosmetics for potential skin reactivity. OBJECTIVES: To confirm the cutaneous acceptability under normal conditions of use of a moisturizing cream in individuals with sensitive skin. METHODS: This was a prospective, single-center, open-label, noncomparative clinical trial conducted in female subjects aged 18-60 years with Fitzpatrick skin phototype I-IV and confirmed sensitive skin. Subjects applied the moisturizer twice daily to the body and/or face for 21 ± 2 days. Product acceptability was based on the occurrence of adverse events, investigator assessment of skin adverse reactions, and subjects' self-reported feelings of skin discomfort. RESULTS: Thirty-five female subjects initiated and completed the study; mean age was 43.2 years and most (89%) had Fitzpatrick skin phototype I-III. No adverse events or skin adverse reactions of erythema, edema, or skin desquamation were observed. There were no participant reports of skin dryness, prickling, or stinging on any occasion. One subject reported a single event of mild itching, which was considered by the investigator as probably not related to study product. CONCLUSIONS: These findings suggest that the moisturizing cream was well tolerated under normal conditions of use and appropriate for topical use on sensitive skin.

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BACKGROUND: Atrial fibrillation (AFib) is the most common form of heart arrhythmia and a potent risk factor for stroke. Nonvitamin K antagonist oral anticoagulants (NOACs) are routinely prescribed to manage AFib stroke risk; however, nonadherence to treatment is a concern. Additional tools that support self-care and medication adherence may benefit patients with AFib. OBJECTIVE: The aim of this study was to evaluate the perceived usability and usefulness of a mobile app designed to support self-care and treatment adherence for AFib patients who are prescribed NOACs. METHODS: A mobile app to support AFib patients was previously developed based on early stage interview and usability test data from clinicians and patients. An exploratory pilot study consisting of naturalistic app use, surveys, and semistructured interviews was then conducted to examine patients' perceptions and everyday use of the app. RESULTS: A total of 12 individuals with an existing diagnosis of nonvalvular AFib completed the 4-week study. The average age of participants was 59 years. All participants somewhat or strongly agreed that the app was easy to use, and 92% (11/12) reported being satisfied or very satisfied with the app. Participant feedback identified changes that may improve app usability and usefulness for patients with AFib. Areas of usability improvement were organized by three themes: app navigation, clarity of app instructions and design intent, and software bugs. Perceptions of app usefulness were grouped by three key variables: core needs of the patient segment, patient workflow while managing AFib, and the app's ability to support the patient's evolving needs. CONCLUSIONS: The results of this study suggest that mobile tools that target self-care and treatment adherence may be helpful to AFib patients, particularly those who are newly diagnosed. Additionally, participant feedback provided insight into the varied needs and health experiences of AFib patients, which may improve the design and targeting of the intervention. Pilot studies that qualitatively examine patient perceptions of usability and usefulness are a valuable and often underutilized method for assessing the real-world acceptability of an intervention. Additional research evaluating the AFib Connect mobile app over a longer period, and including a larger, more diverse sample of AFib patients, will be helpful for understanding whether the app is perceived more broadly to be useful and effective in supporting patient self-care and medication adherence.