An investigation into perceived autonomy support, motivation and competence in chronic pain patients in Ireland: A cross-sectional study.

Autonomy supportive healthcare settings are associated with enhanced behaviour change and self-management strategies in individuals living with chronic disease. The level of autonomy support provided by healthcare professionals to individuals living with chronic pain in Ireland is unknown. A cross-sectional study was completed on participants living with chronic pain (>3 months) in Ireland. Participants (n = 389) completed an anonymous survey constructed of patient reported outcome measures relating to autonomy support (HCCQ), motivation (TSRQ), competence in physical activity (PCS), pain interference (BPI) and psychological factors (PHQ-9, GAD-7). Results showed the median HCCQ (H = 39.287, p < .001), Autonomous Motivation (H = 13.568, p = 0.019) and PCS (H = 30.701, p < .001) scores were significantly different when patients received care from different healthcare professionals. There was a negative correlation between PCS and pain severity (r = -0.32, <0.01), pain interference (r = -0.44, p = <0.01), PHQ-9 (r = -0.50, p = <0.01) and GAD-7 (r = -0.34, p = <0.01). This study has identified that perceived healthcare support in Ireland varies according to the healthcare professional leading pain care. Furthermore, higher levels of self-determination were associated with decreased depression and anxiety in individuals with chronic pain. Given the limited number of multidisciplinary team clinics to provide pain management programs, an alternative cost-effective community led solution is required. The results of this study indicate that allied health professionals may be well placed to fill this void. Future research exploring the barriers to providing healthcare supportive settings is required.

Informing nursing policy: An exploration of digital health research by nurses in England.

AIMS: Digital health technologies are designed, implemented, and evaluated to support clinical practice, enable patients to self-manage illness, and further public and global health. Nursing and health policies often emphasise the importance of evidence-based digital health services to deliver better care. However, the contribution nurses make to digital health research in many countries is unknown. Hence, this study aims to examine digital health research conducted by nurses in England. DESIGN: A bibliometric analysis. METHODS: The CINAHL, MEDLINE, and Scopus databases were searched between 2000 and 2022, and supplemented with a hand search of nurses' research profiles. Results were screened by title, abstract, and full text against eligibility criteria. Data were extracted and bibliometric analysis used to summarise the findings. RESULTS: Mental health nurses produced the most digital health research in England, followed by nurses working in community care, with several disciplines underrepresented or missing. Web/online health services or information was the most researched technology, followed by mobile health and telehealth. Nurses based in the south-east and north-west of England produced the most digital health research, with other regions less well represented. CONCLUSION: Nurse leaders should support nurses to conduct more digital health research by providing dedicated time, funding, and professional development opportunities, particularly in under researched clinical areas, technologies, and geographic regions to further evidence-based practice and patient care. More digital nursing data is needed to support nurse led research in areas like artificial intelligence and data science. The findings supported the national Philips Ives Review by identifying areas of digital nursing research that need more investment in England.

Over twenty years of pedagogical research from Nurse Education in Practice: A bibliometric analysis from 2001 to 2023.

AIM: To present a bibliometric overview of pedagogical research from Nurse Education in Practice from its inception in 2001 up until 2023. BACKGROUND: Bibliometric methods are useful in analysing and understanding the characteristics of scientific publications in a particular field and the influence of specific journals. However, no bibliometric analysis of a nurse education journal has been undertaken to date which would highlight important research trends in this area of nursing and midwifery. METHODS: A total of 2231 publications (articles and reviews only) from Nursing Education in Practice were retrieved from the Scopus database between 2001 and 2023. Several software applications including Microsoft Excel and VOSviewer were used to undertake bibliometric analysis on this dataset. Publication trends such as country analysis, author analysis, keywords analyses (cluster, content and trend analysis) were generated to help understand the volume and scope of pedagogical nursing and midwifery research in this journal. RESULTS: There has been a steady increase in pedagogical research from Nurse Education in Practice since its launch in 2001 up until 2018, with a dip in publications in 2022 most likely due to the impact of restrictions during the coronavirus pandemic. The most prolific institutions publishing in the journal are mainly from the United Kingdom, Australia and the United States, with over eighty countries represented demonstrating its global reach and impact. Nursing students, nursing education, simulation and learning are some of the most frequent author keywords. CONCLUSION: The diversity of pedagogies in nursing and midwifery education, clinical learning and supervision in practice environments, and competence and confidence when transitioning to practice are the most popular research areas in Nurse Education in Practice. This study informs nurse and midwife educators and scholars about the volume and scope of pedagogical research in nursing and midwifery. It also makes recommendations on how to improve aspects of scholarship in education and areas for future pedagogical research.

The application and use of artificial intelligence in cancer nursing: A systematic review.

PURPOSE: Artificial Intelligence is being applied in oncology to improve patient and service outcomes. Yet, there is a limited understanding of how these advanced computational techniques are employed in cancer nursing to inform clinical practice. This review aimed to identify and synthesise evidence on artificial intelligence in cancer nursing. METHODS: CINAHL, MEDLINE, PsycINFO, and PubMed were searched using key terms between January 2010 and December 2022. Titles, abstracts, and then full texts were screened against eligibility criteria, resulting in twenty studies being included. Critical appraisal was undertaken, and relevant data extracted and analysed. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. RESULTS: Artificial intelligence was used in numerous areas including breast, colorectal, liver, and ovarian cancer care among others. Algorithms were trained and tested on primary and secondary datasets to build predictive models of health problems related to cancer. Studies reported this led to improvements in the accuracy of predicting health outcomes or identifying variables that improved outcome prediction. While nurses led most studies, few deployed an artificial intelligence based digital tool with cancer nurses in a real-world setting as studies largely focused on developing and validating predictive models. CONCLUSION: Electronic cancer nursing datasets should be established to enable artificial intelligence techniques to be tested and if effective implemented in digital prediction and other AI-based tools. Cancer nurses need more education on machine learning and natural language processing, so they can lead and contribute to artificial intelligence developments in oncology.

The ChatGPT Effect: Nursing Education and Generative Artificial Intelligence.

This article examines the potential of generative artificial intelligence (AI), such as ChatGPT (Chat Generative Pre-trained Transformer), in nursing education and the associated challenges and recommendations for their use. Generative AI offers potential benefits such as aiding students with assignments, providing realistic patient scenarios for practice, and enabling personalized, interactive learning experiences. However, integrating generative AI in nursing education also presents challenges, including academic integrity issues, the potential for plagiarism and copyright infringements, ethical implications, and the risk of producing misinformation. Clear institutional guidelines, comprehensive student education on generative AI, and tools to detect AI-generated content are recommended to navigate these challenges. The article concludes by urging nurse educators to harness generative AI's potential responsibly, highlighting the rewards of enhanced learning and increased efficiency. The careful navigation of these challenges and strategic implementation of AI is key to realizing the promise of AI in nursing education. [J Nurs Educ. 2024;63(X):XXX-XXX.].

Current Concussion Knowledge, Beliefs, Education, and Management Practices Among Irish Post-Primary PE Teachers.

Purpose: Physical education (PE) teachers play an important role in concussion recognition and management in schools both in an academic and activity based setting. This study aimed to identify Irish post-primary PE teachers' concussion knowledge, beliefs, education and management practices. Methods:  An anonymous online survey, adapted to the Irish context from the validated BAKPAC-TEACH, was completed by 128 PE teachers (female = 74/123; 60.2%; male = 49/123; 39.8%, 36.1 ± 10.9 years), representing 4% of registered PE teachers in Ireland. Results: PE teachers reported 3.5 ± 4.7 students suffer with a sports-related concussion in their classroom annually and 43.9% previously had a student sustain a concussion during their PE class. Most received concussion education (58.6%), largely provided by sporting bodies. They frequently identified dizziness (93.0%) and headaches (92.2%) as concussion symptoms, but less commonly emotional (more emotional = 36.5%, nervous or anxious = 33.6%, sadness = 28.9%) or sleep (35.2%) symptoms. All PE teachers knew that a concussion requires immediate removal from a game/practice. PE teachers demonstrated less perceived knowledge and confidence relating to academic adjustments and return to learn criteria. Just 31.3% reported their school facilitates academic adjustments. Conclusion: Tailored concussion education addressing knowledge gaps highlighted in this study should be developed. A concussion policy and an academic support team in each school should be established and widely publicised to enhance the support of concussed students in returning to school.

Disordered alcohol and substance use in Irish farmers: A cross-sectional survey.

PURPOSE: Farming is a high-pressure occupation. Populations of farmers face significant health risks, including injury, mental illness, and in some cases, heavy alcohol use. However, there is little research on farmers' use of substances beyond alcohol. This study examines factors relating to Irish farmers' disordered alcohol and substance use. METHODS: In accordance with STROBE guidelines for cross-sectional research and reporting, we examined disordered alcohol and substance use in 351 Irish farmers using the Alcohol Use Disorders Identification Tool (AUDIT) and Drug Use Disorders Identification Tool (DUDIT). FINDINGS: While 28% of farmers did not drink, 40% of those who did drink exceeded the AUDIT threshold for disordered use. Similarly, while 95% of farmers did not use substances, 78% of farmers who did use substances exceeded the DUDIT threshold for disordered use. Age was the most important risk factor for disordered alcohol and substance use and correlated with other main risk factors: lower income, no children, part-time farmer, and full-time off-farm roles. Disordered drinking was highest in farmers engaged in full-time education. CONCLUSIONS: This population of Irish farmers report broadly healthy alcohol and substance use behaviors. Irish farmers may serve as a model group whose strengths can be utilized in interventions within and beyond the Irish farming community. Our results confirm the importance of analyzing demographic factors in farmers' drinking and identify younger farmers as especially at-risk for harmful alcohol and substance use.

Electronic Health Record Stress and Burnout Among Clinicians in Hospital Settings: A Systematic Review.

Background: There is growing evidence to suggest that EHRs may be associated with clinician stress and burnout, which could hamper their effective use and introduce risks to patient safety. Objective: This systematic review aimed to examine the association between EHR use and clinicians' stress and burnout in hospital settings, and to identify the contributing factors influencing this relationship. Methods: The search included peer-reviewed published studies between 2000 and 2023 in English in CINAHL, Ovid Medline, Embase, and PsychINFO. Studies that provided specific data regarding clinicians' stress and/or burnout related to EHRs in hospitals were included. A quality assessment of included studies was conducted. Results: Twenty-nine studies were included (25 cross-sectional surveys, one qualitative study, and three mixed methods), which focused on physicians (n = 18), nurses (n = 10) and mixed professions (n = 3). Usability issues and the amount of time spent on the EHR were the most significant predictors, but intensity of the working environment influenced high EHR-related workload and thereby also contributed to stress and burnout. The differences in clinicians' specialties influenced the levels of stress and burnout related to EHRs. Conclusions: This systematic review showed that EHR use was a perceived contributor to clinicians' stress and burnout in hospitals, primarily driven by poor usability and excessive time spent on EHRs. Addressing these issues requires tailored EHR systems, rigorous usability testing, support for the needs of different specialities, qualitative research on EHR stressors, and expanded research in Non-Western contexts.

Associations of eHealth literacy and knowledge with preventive behaviours and psychological distress during the COVID-19 pandemic: a population-based online survey.

OBJECTIVES: To compare the associations of COVID-19 preventive behaviours and depressive and anxiety symptoms with eHealth literacy and COVID-19 knowledge among Korean adults. DESIGN: A cross-sectional online survey was conducted in April 2020. SETTING: Seoul metropolitan area in South Korea. PARTICIPANTS: 1057 Korean adults were recruited. MAIN OUTCOME MEASURES: Associations between eHealth literacy, COVID-19 knowledge, COVID-19 preventive behaviours and psychological distress were computed using Pearson's correlation and logistic regression analyses. eHealth literacy, COVID-19 knowledge, COVID-19 preventive behaviours and psychological distress were weighted by sex and age distribution of the general population in Seoul Metropolitan area. RESULTS: 68.40% (n=723) perceived high eHealth literacy level (eHEALS ≥26), while 57.43% (n=605) had high levels of COVID-19 knowledge (score ≥25). No significant association between eHealth literacy and COVID-19 knowledge was identified (r=0.05, p=0.09). eHealth literacy and COVID-19 knowledge were significantly associated with COVID-19 preventive behaviours (aOR=1.99, 95% CI 1.51 to 2.62 L; aOR=1.81, 95% CI 1.40 to 2.34, respectively). High eHealth literacy was significantly associated with anxiety symptom (aOR=1.71, 95% CI 1.18 to 2.47) and depressive symptom (aOR=1.69, 95% CI 1.24 to 2.30). COVID-19 knowledge had negative and no associations with the symptoms (aOR=0.62, 95% CI 0.46 to 0.86; aOR=0.79, 95% CI 0.60 to 1.03, respectively). High eHealth literacy with low COVID-19 knowledge was positively and significantly associated with COVID-19 preventive behaviours (aOR=2.30, 95% CI 1.52 to 3.43), and anxiety (aOR=1.81, 95% CI 1.09 to 3.01) and depressive symptoms (aOR=2.24, 95% CI 1.41 to 3.55). High eHealth literacy with high COVID-19 knowledge were significantly associated with more preventive behaviours (aOR=3.66, 95% CI 2.47 to 5.42) but no significant associations with anxiety and depressive symptoms. CONCLUSION: We identified that eHealth literacy and COVID-19 knowledge were not associated each other, and differently associated with individuals' COVID-19 preventive behaviours and psychological well-being. Public health strategies should pay attention to enhancing both eHealth literacy and COVID-19 knowledge levels in the public to maximise their COVID-19 preventive behaviours and mitigate their psychological distress during COVID-19 pandemic.

Nursing Informatics' Contribution to One Health.

OBJECTIVES: To summarise contemporary knowledge in nursing informatics related to education, practice, governance and research in advancing One Health. METHODS: This descriptive study combined a theoretical and an empirical approach. Published literature on recent advancements and areas of interest in nursing informatics was explored. In addition, empirical data from International Medical Informatics Association (IMIA) Nursing Informatics (NI) society reports were extracted and categorised into key areas regarding needs, established activities, issues under development and items not current. RESULTS: A total of 1,772 references were identified through bibliographic database searches. After screening and assessment for eligibility, 146 articles were included in the review. Three topics were identified for each key area: 1) education: "building basic nursing informatics competence", "interdisciplinary and interprofessional competence" and "supporting educators competence"; 2) practice: "digital nursing and patient care", "evidence for timely issues in practice" and "patient-centred safe care"; 3) governance: "information systems in healthcare", "standardised documentation in clinical context" and "concepts and interoperability", and 4) research: "informatics literacy and competence", "leadership and management", and "electronic documentation of care". 17 reports from society members were included. The data showed overlap with the literature, but also highlighted needs for further work, including more strategies, methods and competence in nursing informatics to support One Health. CONCLUSIONS: Considering the results of this study, from the literature nursing informatics would appear to have a significant contribution to make to One Health across settings. Future work is needed for international guidelines on roles and policies as well as knowledge sharing.

The Running Injury Continuum: A qualitative examination of recreational runners' description and management of injury.

INTRODUCTION: A critical step in understanding and preventing running-related injuries (RRIs) is appropriately defining RRIs. Current definitions of RRIs may not represent the full process of injury development, failing to capture lower levels of injury that many athletes continue to train through. Understanding runners' description and management of the injury development process may allow for a more appropriate examination of all levels of injury. This study aimed to examine recreational runners' description and management of the injury development process. METHODS: A qualitative focus group study was undertaken. Seven semi-structured focus groups with male (n = 13) and female (n = 18) recreational runners took place. Focus groups were audio and video recorded, and transcribed verbatim. Transcripts were reflexively thematically analysed. A critical friend approach was taken to data coding. Multiple methods of trustworthiness were executed. RESULTS: Runners describe injury on a nine-level continuum, ranging from injury-free to career-ending injury. There are lower and higher levels of injury. Each level of injury is described across four categories of descriptors; physical description, outcome (effect on running and daily life), psychological description, and management. CONCLUSION: The Running Injury Continuum is a tool that can be used for injury surveillance (for healthcare professionals and researchers) and for research investigating RRI risk factors. Healthcare professionals, researchers and coaches must ensure they monitor the development of all levels of RRIs, across all categories of descriptors. Runners need to be educated regarding appropriate self-management strategies for lower level injuries, with access to evidence-based information being a critical management tool.

Injury prevention in ladies Gaelic football referees: Understanding the barriers, facilitators, and preferences of referees.

OBJECTIVES: The injury prevalence in Gaelic games refereeing is high, however few are adopting injury prevention programmes. This study aims to identify the barriers and facilitators to injury prevention strategy success and determine Ladies Gaelic Football referees' preferences for injury prevention strategies and education. DESIGN: Semi-structured interviews were conducted with 11 Ladies Gaelic Football referees (10 men, 1 woman). Two were club level, two were provincial level and 7 were national level referees. Interviews were audio-recorded, transcribed verbatim, and reflexive thematic analysis was completed. This analysis involved examining the data repeatedly and gradually developing sub-themes, themes, and categories related to each core concept. RESULTS: The barriers to injury prevention success included negative attitudes, accessibility issues, lack of education, the state of refereeing and undesirable injury prevention strategy characteristics. Injury prevention promotion, suitable strategy characteristics and open communication were believed to facilitate success. Referees gave their preferences for injury prevention programmes, strategy logistics, and stakeholder roles along with their preferred topics, delivery, educators, characteristics, rollout, and timing for injury prevention education. CONCLUSIONS: Reducing referee injury is critical to the success of Ladies Gaelic Football and other community sports. Governing bodies must develop and support injury prevention programmes and education for referees. These should be designed according to referees' preferences and consider the barriers and facilitators referees have identified to maximise adoption.

Gaelic games players' awareness and use of, and attitudes towards injury prevention exercise programmes.

OBJECTIVE: The aim was to determine the awareness of and use of injury prevention exercise programmes (IPEPs) among adult Gaelic games players and to investigate Gaelic games players' attitudes to injury prevention and barriers and facilitators to successful IPEPs use. METHODS: A recruitment email was sent to all clubs and county boards throughout Ireland (whose email was available online) and the survey was advertised on social media platforms. Adult players completed an anonymous survey, including awareness, use, and attitudes towards injury prevention and injuries. Frequencies and descriptive statistics were conducted, a chi-squared test was used to assess any differences in awareness and use of IPEPs, a Mann-Whitney U test was used to examine differences between groups for attitudes to injury prevention (men vs women; elite vs non-elite). RESULTS: A third of players (32.4%) stated awareness of IPEPs. However, only 13.4% correctly identified one. A significantly greater number of men (35.7%) used IPEPs compared to women (26.5%) (p = 0.04). The Activate (65.5%) and GAA15 (32.5%) were most used. Players had a positive attitude towards injury prevention but agreed that injuries were an issue (68.2%) and stated that their coach didn't have enough knowledge how to use IPEPs was a large barrier (41.6%). CONCLUSION: Despite this positive attitude to injury prevention and believing injuries are an issue, adoption remains low. Organisations/clubs should educate players on the benefits of using IPEPs and support structures put in place to gain greater implementation, which is critical to mitigating the risk of injury.

High PrEP uptake, adherence, persistence and effectiveness outcomes among young Thai men and transgender women who sell sex in Bangkok and Pattaya, Thailand: findings from the open-label combination HIV prevention effectiveness (COPE) study.

Background: Daily oral pre-exposure prophylaxis (PrEP) is effective in preventing HIV infection, but no study has evaluated combination prevention interventions with PrEP for transgender women (TGW) and men who have sex with men (MSM) who sell sex. Methods: The Combination Prevention Effectiveness (COPE) study was a community-based, non-randomized implementation study in Bangkok and Pattaya, Thailand. Participants were HIV-negative MSM and TGW aged 18-26 years who reported exchanging sex with men in the prior 12 months and who met 2014 U.S. Public Health Service PrEP eligibility criteria. The intervention included quarterly HIV testing, semiannual testing for sexually transmitted infections, provision of condoms with lubricant, and the opportunity to initiate or end daily oral PrEP use at any time during study participation. Participants taking PrEP received monthly adherence counseling and short message service reminders. The primary outcome was HIV incidence rate ratio (IRR) on PrEP vs. not on PrEP. Secondary outcomes were PrEP initiation, PrEP use at 12 months, and PrEP adherence. Findings: From October 2017 to August 2019, 846 participants were enrolled: 531 (62.8%) immediately initiated PrEP; 104 (12.3%) subsequently initiated PrEP, and 211 (24.9%) never initiated PrEP. Among those initiating PrEP within 30 days of enrollment; 85.9% were on PrEP at the 12-months. When taking PrEP, participants reported adherent PrEP use at 94.2% of quarterly assessments. Ten HIV seroconversions occurred without PrEP use (incidence rate [IR] = 3.42 per 100 person-years [PY]; 95% CI = 1.64-6.30), while zero cases occurred with PrEP use (IR = 0.0 per 100PY; 95% CI = 0.0-0.62), with IRR = 0.0 (95% CI = 0.0-0.22; p < 0.001). Interpretation: Young Thai MSM and TGW who exchange sex can have high PrEP uptake, persistence and adherence, and low HIV incidence when offered in supportive community-based settings. Funding: U.S. National Institute of Allergy and Infectious Diseases; Centers for Disease Control and Prevention.

Running towards injury? A prospective investigation of factors associated with running injuries.

BACKGROUND: Given the high incidence and heavy burden of running related injuries, large-scale, prospective multifactorial investigations examining potential risk factors are warranted. This study aimed to identify factors associated with running related injuries and to evaluate their potential in injury screening. STUDY DESIGN: Prospective cohort study. MATERIALS AND METHODS: Two hundred and seventy-four recreational runners were recruited. Clinical measures (strength, range of motion, foot position), injury and training history (via questionnaire), impact loading (via accelerometery) and running technique measures were collected at baseline. Runners were tracked for injury for one year via fortnightly check-ins. A binary logistic regression, (injury versus no injury), was performed for each variable univariably, and then adjusting for age, sex and mileage. A multivariable regression was also performed to evaluate the model's discriminative ability. RESULTS: Of the 225 runners included in the final analysis 52% experienced a running related injury. Injury history in the past year, less navicular drop, and measures of running technique (knee, hip, and pelvis kinematics) were associated with increased odds of injury (p < .05). The multivariable logistic regression model was statistically significant, χ2(11) = 56.45, p < .001, correctly classifying 74% of cases with a sensitivity and specificity of 72% and 76%, respectively. The area under the receiver operating characteristic curve was 0.79 (CI95% = 0.73-0.85), demonstrating acceptable discriminative ability. CONCLUSIONS: This study found a number of clinical and running technique factors to be associated with prospective running related injuries among recreational runners. With the exception of injury history, the factors identified as being significantly associated with injury may be modifiable and therefore, could form the basis of interventions. Range of motion, spatiotemporal parameters and strength measures were not associated with injury and thus their utilisation in injury prevention practices should be reconsidered.

Virtual reality simulation-enhanced blood transfusion education for undergraduate nursing students: A randomised controlled trial.

BACKGROUND: Nurse-administered blood transfusion (BT) is a common form of medical treatment, but nursing students are often excluded from participating in and observing BTs during clinical placements. To address clinical placement limitations, nursing educators have increasingly adopted technology-guided simulation pedagogies, including virtual reality (VR) simulation, for nursing students' clinical skills education. OBJECTIVES: To develop VR simulation for BT practice and investigate its effectiveness with nursing students. DESIGN: A single-blinded, two-arm randomised controlled trial. SETTINGS: One university in Hong Kong. PARTICIPANTS: A total of 151 nursing students enrolled in a nursing undergraduate course at a university in Hong Kong were recruited via convenience sampling in March 2022. METHODS: Evidence-based VR simulation videos consisting of 1) animated blood formation physiology and side effects of BT and 2) 360° BT nursing practice were developed. The nursing students were randomly allocated into intervention and control groups. The intervention group (n = 75) received the usual BT education (i.e. Zoom lecture) with the developed VR video education, whereas the control group (n = 76) received the usual BT education (Zoom). The BT knowledge (RBTKQ-O), student satisfaction and self-confidence (SSSC) and self-efficacy (GSES) of BT practice were measured before and after BT education. Intention-to-treat analyses were performed. RESULTS: The primary and secondary outcomes (RBTKQ-O, SSCS and GSES, respectively) improved over time in both groups. Analysis of covariance revealed that students who received VR simulation reported higher post-intervention measurement scores in BT knowledge and SSCS than those who did not receive VR simulation. CONCLUSIONS: VR simulation-enhanced BT education effectively enhances the knowledge and SSCS of BT practice amongst nursing students. Nurse educators may adopt VR simulation to enhance the effectiveness of existing BT education for nursing students.

Feasibility of 5-fluorouracil and imiquimod for the topical treatment of cervical intraepithelial neoplasias (CIN) 2/3.

OBJECTIVES: To determine the feasibility (as measured by tolerability and safety) and efficacy of topical 5-fluorouracil (5-FU) and imiquimod for the treatment of cervical intraepithelial neoplasia (CIN) 2/3. METHODS: This pilot prospective study was conducted in women aged 18-45 years with p16+ CIN 2/3. Participants underwent an 8-week alternating regimen of self-applied 5% 5-FU on weeks 1, 3, 5, and 7 and physician-applied imiquimod on weeks 2, 4, 6, and 8. Adverse events (AEs) were collected by symptom diary and clinical exam. Feasibility was measured by tolerability and safety (AEs) of the study intervention. Tolerability was assessed as the number of participants able to apply 50% or more of the treatment doses. The safety outcome was calculated as the number of participants who experienced "specified AEs" defined as possibly, probably, or definitely related grade 2 or worse AE or grade 1 genital AEs (blisters, ulcerations, or pustules) lasting more than 5 days. The efficacy of the intervention was determined by histology and high-risk human papillomavirus (hrHPV) testing was done after treatment. RESULTS: The median age of the 13 participants was 27 ± 2.9 years. Eleven (84.61%) participants applied 50% or more of the treatment. All participants reported grade 1 AEs; 6 (46.15%) reported grade 2 AEs; and 0 reported grade 3/4 AEs. Three (23.08%) participants had specified AEs. Histologic regression to normal or CIN 1 among those completing 50% or more of the treatment doses was observed in 10 (90.91%) participants, and 7 (63.63%) tested negative for hr-HPV at the end of the study. CONCLUSIONS: Topical treatment for CIN 2/3 with 5-FU/imiquimod is feasible, with preliminary evidence of efficacy. Topical therapies need further investigation as adjuncts or alternatives to surgical therapy for CIN 2/3.

Randomized controlled phase IIa clinical trial of safety, pharmacokinetics and pharmacodynamics of tenofovir and tenofovir plus levonorgestrel releasing intravaginal rings used by women in Kenya.

Introduction: Globally, many young women face the overlapping burden of HIV infection and unintended pregnancy. Protection against both may benefit from safe and effective multipurpose prevention technologies. Methods: Healthy women ages 18-34 years, not pregnant, seronegative for HIV and hepatitis B surface antigen, not using hormonal contraception, and at low risk for HIV were randomized 2:2:1 to continuous use of a tenofovir/levonorgestrel (TFV/LNG), TFV, or placebo intravaginal ring (IVR). In addition to assessing genital and systemic safety, we determined TFV concentrations in plasma and cervicovaginal fluid (CVF) and LNG levels in serum using tandem liquid chromatography-mass spectrometry. We further evaluated TFV pharmacodynamics (PD) through ex vivo CVF activity against both human immunodeficiency virus (HIV)-1 and herpes simplex virus (HSV)-2, and LNG PD using cervical mucus quality markers and serum progesterone for ovulation inhibition. Results: Among 312 women screened, 27 were randomized to use one of the following IVRs: TFV/LNG (n = 11); TFV-only (n = 11); or placebo (n = 5). Most screening failures were due to vaginal infections. The median days of IVR use was 68 [interquartile range (IQR), 36-90]. Adverse events (AEs) were distributed similarly among the three arms. There were two non-product related AEs graded >2. No visible genital lesions were observed. Steady state geometric mean amount (ssGMA) of vaginal TFV was comparable in the TFV/LNG and TFV IVR groups, 43,988 ng/swab (95% CI, 31,232, 61,954) and 30337 ng/swab (95% CI, 18,152, 50,702), respectively. Plasma TFV steady state geometric mean concentration (ssGMC) was <10 ng/ml for both TFV IVRs. In vitro, CVF anti-HIV-1 activity showed increased HIV inhibition over baseline following TFV-eluting IVR use, from a median of 7.1% to 84.4% in TFV/LNG, 15.0% to 89.5% in TFV-only, and -27.1% to -20.1% in placebo participants. Similarly, anti-HSV-2 activity in CVF increased >50 fold after use of TFV-containing IVRs. LNG serum ssGMC was 241 pg/ml (95% CI 185, 314) with rapid rise after TFV/LNG IVR insertion and decline 24-hours post-removal (586 pg/ml [95% CI 473, 726] and 87 pg/ml [95% CI 64, 119], respectively). Conclusion: TFV/LNG and TFV-only IVRs were safe and well tolerated among Kenyan women. Pharmacokinetics and markers of protection against HIV-1, HSV-2, and unintended pregnancy suggest the potential for clinical efficacy of the multipurpose TFV/LNG IVR. Clinical Trial Registration: NCT03762382 [https://clinicaltrials.gov/ct2/show/NCT03762382].

Conducting a systematic review and evaluation of commercially available mobile applications (apps) on a health-related topic: the TECH approach and a step-by-step methodological guide.

OBJECTIVES: To provide an overview of the methodological considerations for conducting commercial smartphone health app reviews (mHealth reviews), with the aim of systematising the process and supporting high-quality evaluations of mHealth apps. DESIGN: Synthesis of our research team's experiences of conducting and publishing various reviews of mHealth apps available on app stores and hand-searching the top medical informatics journals (eg, The Lancet Digital Health, npj Digital Medicine, Journal of Biomedical Informatics and the Journal of the American Medical Informatics Association) over the last five years (2018-2022) to identify other app reviews to contribute to the discussion of this method and supporting framework for developing a research (review) question and determining the eligibility criteria. RESULTS: We present seven steps to support rigour in conducting reviews of health apps available on the app market: (1) writing a research question or aims, (2) conducting scoping searches and developing the protocol, (3) determining the eligibility criteria using the TECH framework, (4) conducting the final search and screening of health apps, (5) data extraction, (6) quality, functionality and other assessments and (7) analysis and synthesis of findings. We introduce the novel TECH approach to developing review questions and the eligibility criteria, which considers the Target user, Evaluation focus, Connectedness and the Health domain. Patient and public involvement and engagement opportunities are acknowledged, including co-developing the protocol and undertaking quality or usability assessments. CONCLUSION: Commercial mHealth app reviews can provide important insights into the health app market, including the availability of apps and their quality and functionality. We have outlined seven key steps for conducting rigorous health app reviews in addition to the TECH acronym, which can support researchers in writing research questions and determining the eligibility criteria. Future work will include a collaborative effort to develop reporting guidelines and a quality appraisal tool to ensure transparency and quality in systematic app reviews.