A collaborative approach to research study recruitment in PLWH during the SARS CoV-2 pandemic

Background: Since COVID there are fewer site investigator meetings for non-CTIMP studies to discuss recruitment barriers. Additionally, literature highlights various research trials that have successfully recruited do not report their strategies, consequently impacting ability to learn from success. The pandemic has had considerable impact on enrolment to clinical research, thus services have needed to revaluate their approach. Following the pandemic, patients report more likely to engage in research if offered remote or combined visits. Method(s): We reviewed recruitment strategies at our clinic for two observational studies with large targets (SCAPE-HIV, Positive Voices). SCAPE-HIV, a prospective study exploring immune responses of PLWH to SARS CoV2 infection and vaccination. Positive Voices, a crosssectional questionnaire study. Minimum recruitment targets, 600 and 262 respectively. SCAPE involves open-offer enrolment, Positive Voices from a defined pre-selected cohort. Initial approaches identified people opportunistically at clinic visits, with research staff offering information. However, reaching our targets through COVID became challenging and a move to virtual appointments condensed our opportunities to approach. To increase recruitment, engagement and training of NHS nursing and clinical staff was undertaken alongside remote patient contact. Result(s): After implementing collaborative methods, Positive Voices recruitment increased to 170 in July/ August 2022 (73 in May/June). SCAPE recruitment also improved. Hybrid nurse practitioners dedicating time to approach people during clinic visits and clinic staff involvement attributed to this rise, representing over half of consents (Table A). The clinic team's substantial knowledge of our cohort, combined with their openness to research, leads to greater understanding of how likely individuals are to accept studies. Conclusion(s): Positive Voices and SCAPE-HIV studies have been successful with recruitment due to a collaborative approach, resulting in our site being the highest current recruiting site involved in Positive Voices. This approach has helped motivate the NHS team to become more involved and has become an exemplar for clinical trial delivery within our Trust. (Table Presented).

Slack as a virtual undergraduate dermatology community: a pilot

Dermatology has long been recognized as under-represented in UK's undergraduate curricula. With a diagnostic and educational toolkit that is heavily centred around face-to-face clinical examination, dermatology education has been disproportionately affected by the COVID-19 pandemic. Innovative approaches to distance teaching and learning within dermatology are essential, but historically have been unidirectional with a lack of community and patient-centred resources readily available. Online channel-based messaging apps such as Slack offer an opportunity to engage students in remote, multimodal collaborative learning by reproducing a classroom environment in the virtual space, while simultaneously maintaining a strong focus on patient care. The aim of this study was to determine the feasibility, acceptability and proof of concept for an online Slack community as an undergraduate dermatology learning platform. Undergraduate medical students participated in an online classroom for 6 weeks with a structured teaching programme encompassing online casebased discussions, seminars and journal clubs. The platform was facilitated by junior doctors (n = 10) and featured patient educators (n = 6). Students, faculty and patient educators completed a postcourse evaluation. In addition, students completed a pre-and postintervention dermatology quiz to determine knowledge acquisition. Mixed-methods analyses were applied including quantitative analyses to explore data trends and qualitative phenomenographic analyses to assimilate key underlying themes. Students (n = 65) were enrolled to join the platform for a 6-week period. The evaluation was completed by students (n = 52) from UK universities (n = 27). The majority of students (n = 27) interacted with the platform as passive observers (<= 5 active interactions). A small group of 'super users' (n = 4) actively engaged with the platform over 100 times during the study period. Ninety-six per cent of participants and 100% of faculty agreed that the overall quality of the course was excellent. No statistically significant difference in the pre-and postcourse dermatology quiz scores was noted, possibly owing to suboptimal levels of active engagement with the platform from many users. Barriers to engagement cited by the students included high university workload and the lack of a timetable for live sessions. A community-based online classroom can act as an enjoyable, acceptable and collaborative means of supplementing traditional educational methodologies for teaching dermatology to undergraduate medical students. Its ease of use and supportive nature can facilitate patient involvement, as well as other innovative approaches to teaching and learning dermatology, such as interuniversity collaboration and gamification of learning. Such advances may provide vital safeguards against the reduction in face-to-face learning that has accompanied the pandemic.

Disorganised patellar tendon structure remains inert despite continued exposure to high loading environments

Introduction: Ultrasound tissue characterisation (UTC) is a unique imaging modality used to investigate structural changes of the patellar tendon. Adolescent athletes who load their knees may be susceptible to patellar tendon abnormality(s) (PTA), characterised by areas of structural disorganisation. Presence of a PTA is a risk factor for the development of pain and dysfunction. This longitudinal study aimed to investigate patellar tendon structural changes in adolescent athletes with PTA. Method(s): Adolescent basketball, volleyball and Australian Rules football athletes aged 11-14 years were recruited between March and November 2017. Data collection occurred biannually over a 2.5-year period or until ceased with the covid-19 pandemic. Bilateral UTC scans of the patellar tendon were collected at each time point. Tendon structure was quantified into four echotypes (echotype I to IV), with echotype I representing the highest structural integrity and echotype IV representing the least amount of structural integrity. The proportion of each echotype was calculated using UTC software for a region of interest (2cm distal from the disappearance of the inferior patella pole). Statistical analysis was conducted for athletes who presented at the initial data collection session with a PTA(s). Maturity status was defined by Mirwald et al. (2002). Generalised additive modelling and generalised additive mixed modelling were used to investigate the relationship between tendon structure and maturity status. Result(s): Of the 173 adolescent athletes recruited for this longitudinal study, nine athletes presented with a PTA at the initial testing session (n=9/173 = 5.2%). When measured against maturity offset (years away from the peak growth spurt of adolescence) echotype 1 (healthy aligned tendon structure) increased in proportions (df=2.25, f=4.43, p=<0.05) while echotype II decreased (df =2.59, f=3.80, p=<0.05). Echotypes III and IV (representing disorganised tendon structure) remained stable in proportions throughout the duration of this longitudinal study (df =1.0, f=0.24 p=0.6 and df=1.0, f =0.27, p=0.6 respectively). Discussion(s): This longitudinal study demonstrates that despite adolescent athletes having the presence of areas of disorganised tendon structure, the proximal patellar tendon structure improves as seen via an increase in echotype I and decrease in echotype II. Areas of disorganised tendon structure (echotypes III and IV) appear inert during the adolescent growth spurt, that is, proportions of echotypes neither increase nor decrease despite continued exposure to high loading environments. Impact and application to the field * Imaging of the patellar tendon for adolescent athletes after the initial identification of tendon abnormality may not be useful given these areas of structural disorganisation appear inert. * Management and intervention strategies for adolescent athletes experiencing tendon problems should focus on clinical outcomes rather than imaging as areas of disorganisation are unlikely to change post development of PTA. * Adolescent athletes may continue to train and compete in high loading environments without further increases to areas of structural disorganisation of the tendon. Conflict of Interest Statement: The authors of this were financially supported with an Australian Government Research Training Program (PhD) scholarship and the General Electric and National Basketball Association Orthopaedics and Sports Medicine Collaboration. The authors certify that they have no affiliations or financial involvement with any entity that has a direct financial interest in the subject matter of this research. Copyright © 2022

Male and female adolescent athletes develop patellar tendon abnormalities at different maturity stages: a longitudinal study of 173 athletes

Introduction: Patellar tendon abnormalities have been reported to occur in adolescent athletes who load the patellar tendon. The adolescent growth spurt has been suggested as a critical time-point for the formation of a healthy patellar tendon. Presence of a patellar tendon abnormality has been identified as a risk factor for the development of pain and dysfunction in later life. This longitudinal study aims to investigate factors associated with the development of patellar tendon abnormality during the critical time period of adolescence. Method(s): 173 athletes were recruited from the specialised sporting programs of basketball, volleyball, and Australian Rules football. Athletes were tested biannually for up to 2.5 years or until data collection ceased due to the covid-19 pandemic. To be eligible for inclusion, athletes had to be active in a selected sporting program and be between the ages of 11-14 at the initial data collection. Bilateral patellar tendon ultrasound tissue characterisation scans were conducted at each data collection point for each athlete to identify patellar tendon abnormality. Descriptive analysis was conducted for any athlete that had or went to develop a patellar tendon abnormality during the longitudinal study period. Maturity status of each athlete was calculated via the maturity offset equations (Mirwald et al (2002). Result(s): Seventeen of the 173 (9.8%) athletes developed a patellar tendon abnormality during this longitudinal study. Nine out of 10 male athletes were post-peak height velocity (PHV) when a patellar tendon abnormality developed. All female athletes (n=7) were peri-PHV (one year either side of the peak growth spurt) when they developed a patellar tendon abnormality. Male athletes who developed abnormality reached PHV at 14.5+/-0.5 vs. normative data of 13.7+/-1.4 years. Female athletes who developed abnormality reached PHV at 15.5+/-0.5 vs. normative data of 12.1+/-1.4 years. Discussion(s): The development of patellar tendon abnormalities appears to differ between male and female athletes with female athletes developing abnormality peri-PHV and male athletes developing abnormalities post-PHV. This raises the important question of sex differences in the development of patellar tendon abnormality during the adolescent growth spurt and suggests that adolescent athletes who develop patellar tendon abnormality achieve their peak growth spurt at a later chronological age as opposed to athletes that do not develop patellar tendon abnormality. Impact and application to the field * This longitudinal study is the first to highlight sex differences in the development of patellar tendon abnormality in adolescent athletes, suggesting that aetiology of this condition may differ by sex. * Adolescent athletes who achieve PHV at a later chronological age may be more susceptible to development of patellar tendon abnormalities and thus risk of future knee pain and dysfunction. * Clinicians should consider and monitor maturity status of adolescent athletes identified as being at risk of developing patellar tendon problems, paying particular attention to athletes who experience a delayed peak growth spurt so that early identification of tendon problems and effective management strategies can be implemented. Conflict of Interest Statement: The authors of this were financially supported with an Australian Government Research Training Program (PhD) scholarship and the General Electric and National Basketball Association Orthopaedics and Sports Medicine Collaboration. The authors certify that they have no affiliations or financial involvement with any entity that has a direct financial interest in the subject matter of this research. Copyright © 2022

PERSPECTIVES OF PRIMARY CARE LEADERS ON THE CHALLENGES AND OPPORTUNITIES OF LEADING THROUGH THE EARLY COVID-19 PANDEMIC

BACKGROUND: The initial onset of the COVID-19 pandemic presented new challenges to primary care, but little is known about the experience of practice leaders and their strategies for managing their teams as the crisis unfolded. In this study, we qualitatively describe the experience of leaders in a range of primary care delivery organizations, and their strategies for leading their teams during the first year of the COVID-19 pandemic. METHODS: Qualitative study -We performed semi-structured interviews with a purposive sample of 15 clinical leaders in organizations in the United States that deliver primary care between 9/15/2020 and 8/31/2021. Organizations included academic health centers, federally qualified health centers, non-academic health systems, and independent private practices. Interviews were recorded and transcribed verbatim. An iterative grounded review with open coding of transcripts was performed by the research team, followed by analysis using an immersion/crystallization approach. RESULTS: Early in the pandemic, leaders made many critical decisions at a rapid pace despite uncertainty and constant change. Clinicians and staff experienced fear regarding personal health, potential workplace exposures, and job security, while also having a strong sense of purpose and wanting to help with pandemic response. Leaders used multiple strategies for managing their teams, including: 1) Being present, listening, acknowledging uncertainty and showing vulnerability 2) Frequent, transparent communication regarding uncertain and changing conditions, 3) Deepening relationships among team members, and building new relationships within and across organizational boundaries, and 4) Supporting emerging roles and changing decision making systems by a) delegating work and elevating new leaders balanced with personal involvement in problem solving and b) allowing employees to change care processes independently. The experience of leaders was mediated by the size and complexity of their organization, and their role within it. Leaders noted that their organizations served as essential sources of reliable information to patients, but also that in some cases, relationships with patients and communities were stressed over disagreements over public health measures, mask use and vaccines, leading to clinician and staff burnout. Fee for service payment was noted as a barrier to effective pandemic response, and to primary care function in general, while leaders of capitated organizations expressed excitement over their ability to rapidly adapt. CONCLUSIONS: Primary care leaders used strategies including being present, listening and acknowledging uncertainty;frequent communication;enhancing relationships;and employing more transparent and participatory decision making models. Such practices may persist, strengthening organizational capacity, but damaged relationships with patients and communities may present ongoing challenges.

HIV PATIENT PREFERENCES FOR CARE: RESETTING FOR A NEW NORMAL

Introduction During Covid we adopted telephone appointments as standard of care, with patients attending for monitoring bloods as required or for specific clinical reasons. This patient survey was undertaken to formally collate patient views to inform our future approach to provision of care. Methods A literature review and semi structured telephone interviews were used to develop the survey questions and a link to the on-line survey tool was then texted to all our patient cohort who had given permission to receive text messages. Results Twenty-eight out of approximately 160 patients responded to the survey. All participants rated the service good (2/28) or very good (26/28). Patients preferred to attend once or twice per year ((15/28 and 13/28 respectively). Telephone appointments were felt to be either moderately or very convenient (11 and 15 patients respectively), however only a minority (6 patients) expressed a preference for video consultations, with 12 patients expressing a dislike. Of the 28 patients, 17 would prefer consultations face to face, 8 via telephone and only 2 by video. We also asked patients what was most important in how they receive their care. Face to face appointments (20 patients) were most important, followed by confidentiality (16) and continuity of care (13). Most patients (22/28) would be happy to complete a short questionnaire prior to their appointment to identify any issues they wished to discuss. Discussion Patients were happy with the care that they received but were keen to return to face to face appointments. (Table Presented).

FACE TO FACE VERSUS TELEPHONE CONSULTATION: RESETTING THE BALANCE

Introduction During Covid, we adopted telephone consultations for initial history taking, with in person follow-up appointments where clinically indicated. This review was undertaken to identify the proportion of patients managed remotely only and to adjust algorithms for future appointments. Methods We retrospectively audited consultations over the course of one month. We reviewed basic demographic data, along with presenting complaints and management. Results Of 176 telephone consultations, 36 (20.45%) were managed remotely. The majority were either positive on online testing (8) or chlamydia contacts (10) and received postal treatment. Of the 16 remaining, 4 were signposted to online testing, 4 received management for known herpes and a further 4 needed advice or wanted to discuss prior results. Amongst the 48/140 attendees reviewed, the commonest presentations in women were vaginal discharge (9/26), skin lesions (8/26, 4 confirmed warts) and pain (6/26). In men, 10/ 22 had skin lesions (6/22 with warts) and 6 had discharge/ dysuria. Three contacts of infections attended due to symptoms or needing additional testing, 1 patient because of insufficient bloods from home testing, and 1 following a needlestick injury. Two under 18's were assessed by telephone, both subsequently reviewed in the department. Safeguarding issues were addressed for one of these. Discussion This review has identified that very few asymptomatic patients required triage, and about 1/5 presentations were managed remotely. Younger and vulnerable patients were still signposted into service, as were those needing further examination or testing. Our future approach for blended service provision will reflect this.

World ethanol producers' rankings in major reshuffle

USA continues to be the largest producer of ethanol globally followed by Brazil. The Covid-19 pandemic impacted the sector adversely as the rise in unemployment, plus the attendant restrictions on movement resulted in people driving much less than before and thereby decreasing demand for transportation fuel. US companies Poet, Valero and ADM will continue to dominate the league table of top producers. The Brazilian company Raizen is expected to move up in rankings (to 4) in 2021/22 following the recent acquisition of the sugar-ethanol producer Biosev.

Timeline for site onboarding for an nih funded clinical trial in pediatric gastroenterology & nutrition: Ikaneat

Prospective multicenter center studies are needed to develop inter-institutional clinical pathways and improve health care practices. Multicenter studies are encouraged by the National Institutes of Health and desired by investigators. However, investigator-initiated, randomized, controlled, multi-site trials face many challenges1, one of which is the timeline involved in contracting, regulatory and human subjects' requirements. These steps must be finalized prior to each site's activation to engage in any study-related activities. Research indicates these timelines can be especially challenging for pediatric trials, and trials involving medically complex patients.2,3 Given the typical investigator-initiated funding cycle of five years or less, understanding the timeline necessary to achieve multi-site activation is key to the conduct of multi-site trials, especially trials that are complex. Therefore, the purpose of the current analysis is to present the timeline for site activation across nine sites in the United States participating in the iKanEat trial (NCT03815019;NIH R01 HD093933) from October 2018 thru present. iKanEat is a prospective randomized controlled trial conducted across 10 sites in the United States focused on the use of megesterol as part of a pediatric tube weaning program. Data were collected from the regulatory system at the primary site regarding the variables of: expressing interest, IRB approval, contract approval, site activation, and first subject recruited. Data indicate that time from expressing interest in the study to full IRB approval averaged 230 days (range = 70-396) and time to full contract approval averaged 190 days (range = 88-190). The time for clearing all administrative hurdles and moving to full site activation for subject recruitment averaged 288 days (range = 253-350) and the time from site activation to consenting a first patient to the study averaged 463 days (range = 314-669). Reasons for delays collected from each site included coordination with the investigational pharmacy, site accounting set up, and scheduling site trainings with the investigative team at the primary site. It is also likely that the outbreak of SARS COV-2, and subsequent pauses in site activities, impacted these timelines, especially from March 2020-March 2021. These longer than anticipated timelines have put subject recruitment goals at risk and also increased cost for the current study. These findings indicate that at least one year should be built into study timelines prior to subject recruitment. This information should be helpful to other investigators planning multi-site investigator-initiated pediatric trials. Future research should examine specific methods for decreasing these timelines, with an emphasis on those trials that involve medically complex children.

Domestic abuse screening in people living with HIV

Background: In 2019, 2.4 million adults reported domestic abuse (DA) in the UK. During the COVID-19 pandemic, DA organisations saw an increase by 25% in calls, and 150% in access to information online (Source: ONS). There is increasing evidence of DA in PLWH, with correlation to poor health outcomes including death. Studies have specifically reported on DA screening in PLWH, showing female heterosexuals as predominantly affected. BHIVA recommends asking about previous or current intimate partner violence at initial assessment, and six monthly. We aimed to improve routine DA routine inquiry of PLWH at a London HIV service and determine the DA prevalence in PLWH. Method: All clinicians conducting consultations were asked to routinely ask PLWH about DA. All staff were trained on how to screen and manage DA cases, including national guidance from BASHH. Weekly reminders with DA screening rates were circulated, with continued support and encouragement to continue asking. Disclosures were referred to health advisors, and reviewed by the safeguarding team. Results: Routine DA screening improved from an average of 8% (range 0-19%) pre-lockdown (3148 asked from 10/2019-02/ 2020), to 33% (range 0-56%) post-lockdown (2530 asked from 03/2020-09/ 20202) (figure 1). 17 patients (0.3%) reported DA. 59% were male, of whom 70% homosexual, 53% Caucasian and 47% Black African-Caribbean. Non-British Caucasians accounted for 60% of all those that reported DA. Pre-lockdown 35% (6/17) disclosed DA, rising to 65% (11/17) post-lockdown. 89% were asked twice before disclosure, one was asked four times. Conclusion: Routine DA screening for PLWH by clinicians within the HIV service improved from 8% to 33%, peaking at 56%. The increase in screening, almost doubled DA disclosure. The majority did not disclose on first DA inquiry. Education and training, with weekly continued support and encouragement were the main interventions used to drive improvement. The majority of DA survivors in PLWH were homosexual Caucasian males, different to previous studies. Screening needs to be a continuous process, with everyone being asked, if we are to truly impact preventing the consequences of DA. (Table Presented).

An online forum to support consultant psychiatrists in their first five years of practice, introduced during the COVID-19 pandemic

IntroductionIn the United Kingdom, the move from trainee to consultant psychiatrist can be both exciting and daunting. Trainee psychiatrists have access to support and weekly supervision that is not available to consultants. Having an organised meeting for new consultants could help bridge this gap with peer-led support.ObjectivesImproving support and guidance to new consultants Networking with peers Promoting wellbeing, good clinical practice and career developmentMethodsWe identified a group of 85 consultants in their first five years of practice. Meetings were held online using videoconference. Senior leaders presented at each meeting, with a group discussion at the end. We surveyed attendees using an online platform.ResultsWe had excellent attendance rates from the group, with 30 to 45 consultants attending each webinar. Over 60% of attendees had been a consultant for less than a year. For 90%, this was their first experience of a new consultant forum. Attendees gave excellent feedback (Table). Being able to meet consultants from different specialties, hearing career stories from senior leaders and how they have managed the COVID-19 pandemic were cited as benefits.Table: Feedback scores (0 = not useful to 100 = very useful)StatementScoreThe forum helped me feel supported75Topics covered are relevant to me79I feel more connected with colleagues71ConclusionsThe forum was popular and the feedback was excellent. Using an online format worked well and made it easier to organise and plan sessions. There is potential to implement similar fora for other senior psychiatrists across Europe.

Slack as a virtual undergraduate dermatology community: a pilot study.

BACKGROUND: Dermatology is under-represented in UK undergraduate curricula, and with a diagnostic and educational toolkit that is heavily centred on face-to-face (F2F) clinical examination, dermatology education has been disproportionately affected by the COVID-19 pandemic. Online channel-based messaging apps such as Slack offer an opportunity to engage students in remote, multimodal collaborative learning by reproducing a classroom environment in the virtual space. AIM: To determine the feasibility, acceptability and proof of concept for an online Slack community in undergraduate dermatology education. METHODS: Undergraduate medical students participated in an online classroom for a 6-week programme encompassing case-based discussions, seminars and journal clubs. The platform was facilitated by junior doctors (n = 10) and patient educators (n = 6). Students and faculty completed a post-course evaluation. Students additionally completed a pre- and post-intervention dermatology quiz. Mixed methods analyses included quantitative analyses to explore data trends and qualitative phenomenographic analyses to assimilate key underlying themes. RESULTS: Students (n = 65) were enrolled to join the platform. The evaluation was completed by students (n = 52) from UK universities (n = 27). The majority of students (n = 27) interacted with the platform as passive observers (≤ 5 active interactions with the channel), with a small group (n = 4) of 'super-users' (≥ 100 active interactions). The overall quality of the course was described as 'excellent' by 96% of participants and 100% of faculty. CONCLUSION: A community-based online classroom can act as an enjoyable, acceptable and collaborative means of delivering dermatology education to undergraduate medical students. Its ease of use and supportive nature may also facilitate patient involvement. Such advances may provide vital safeguards against the reduction in F2F learning that has accompanied the COVID-19 pandemic.

Global coherence, healing meditations using heartmath applications during covid-19 lockdown

International lockdown and social distancing as a response to COVID-19 indicate planetary interconnectedness. This South African case study compared global coherence, healing meditations using HeartMath Global Coherence and Inner Balance electronic applications (apps) before and during a 3-week lockdown period. Methodology integrated quantitative and qualitative components. Findings revealed significant meditation coherence and achievement increases and significant correlational cluster patterns between meditation data and global coherence increases, magnetometer readings. Local and global healing phenomena, dynamics, mechanisms and implications are discussed. Contribution: This article represents research within a paradigm in which the intersection of philosophy, religious studies, social sciences, humanities and natural sciences generate an interdisciplinary, multidisciplinary and transdisciplinary contested discourse. © 2020. The Authors. Licensee: AOSIS.

SARS-CoV-2 spike protein predicted to form complexes with host receptor protein orthologues from a broad range of mammals.

SARS-CoV-2 has a zoonotic origin and was transmitted to humans via an undetermined intermediate host, leading to infections in humans and other mammals. To enter host cells, the viral spike protein (S-protein) binds to its receptor, ACE2, and is then processed by TMPRSS2. Whilst receptor binding contributes to the viral host range, S-protein:ACE2 complexes from other animals have not been investigated widely. To predict infection risks, we modelled S-protein:ACE2 complexes from 215 vertebrate species, calculated changes in the energy of the complex caused by mutations in each species, relative to human ACE2, and correlated these changes with COVID-19 infection data. We also analysed structural interactions to better understand the key residues contributing to affinity. We predict that mutations are more detrimental in ACE2 than TMPRSS2. Finally, we demonstrate phylogenetically that human SARS-CoV-2 strains have been isolated in animals. Our results suggest that SARS-CoV-2 can infect a broad range of mammals, but few fish, birds or reptiles. Susceptible animals could serve as reservoirs of the virus, necessitating careful ongoing animal management and surveillance.