Understanding the unintended consequences of new healthcare technologies aimed at supporting patient safety: a qualitative study

Introduction: Technologies such as electronic prescribing, clinical decision support systems, and electronic medication dispensers, are increasingly being introduced into healthcare. Existing toolkits focus on the implementation of such technologies, rather than identifying and mitigating any unintended consequences technologies may have on patient safety. They also focus on high-level organisational issues instead of those faced by end-users: frontline staff, patients and carers. Aim(s): To identify and classify types of unintended consequences that may be encountered by technologies' end-users, in order to inform development of a tool for identifying and preventing technology-related risks on patient safety. Method(s): Five focus group discussions with healthcare professionals, patients and carers were conducted through video-conferencing. Healthcare professionals with experience of using/implementing healthcare technologies and known to the research team via professional networks were invited to participate. Patient/carer participants were recruited using convenience sampling via an external research-participant organisation. Participants were asked to identify patient safety risks associated with the use of healthcare technologies, drawn from their own experiences and through consideration of hypothetical risks. Discussions were audio-recorded and transcribed verbatim. Transcripts were analysed by two researchers (NVivo R1.6) and two public partners (manually), using iterative inductive thematic analysis. Result(s): Eleven healthcare professionals and 29 patients and carers participated in focus groups. Three focus groups comprised patients, carers, and healthcare professionals. Two involved solely patients and carers. Analysis revealed five areas of unintended consequences (Table 1). Most unintended consequences identified by patients and carers were similar to those described by healthcare professionals. Healthcare professionals also described additional unintended consequences associated with technologies designed specifically for their use. Conclusion(s): A limitation of the study is that many of the unintended consequences identified related to virtual health technologies used during the COVID-19 pandemic, which may affect generalisability. A strength is that unintended consequences that have been overlooked in existing literature, such as the build-up of patients' psychological dependence on technologies, were identified. Developing a tool based on these will allow implementers and users of healthcare technologies to consider such issues and address the potential risks they may have on patient safety before healthcare technologies are fully implemented in practice.

Mucociliary transport deficiency and disease progression in Syrian hamsters with SARS-CoV-2 infection.

Substantial clinical evidence supports the notion that ciliary function in the airways is important in COVID-19 pathogenesis. Although ciliary damage has been observed in both in vitro and in vivo models, the extent or nature of impairment of mucociliary transport (MCT) in in vivo models remains unknown. We hypothesize that SARS-CoV-2 infection results in MCT deficiency in the airways of golden Syrian hamsters that precedes pathological injury in lung parenchyma. Micro-optical coherence tomography was used to quantitate functional changes in the MCT apparatus. Both genomic and subgenomic viral RNA pathological and physiological changes were monitored in parallel. We show that SARS-CoV-2 infection caused a 67% decrease in MCT rate as early as 2 days postinfection (dpi) in hamsters, principally due to 79% diminished airway coverage of motile cilia. Correlating quantitation of physiological, virological, and pathological changes reveals steadily descending infection from the upper airways to lower airways to lung parenchyma within 7 dpi. Our results indicate that functional deficits of the MCT apparatus are a key aspect of COVID-19 pathogenesis, may extend viral retention, and could pose a risk factor for secondary infection. Clinically, monitoring abnormal ciliated cell function may indicate disease progression. Therapies directed toward the MCT apparatus deserve further investigation.

Physical Activity Patterns among Urban Youth during the COVID-19 Pandemic

In a population of youth affiliated with a large Sport for Development facility in downtown Toronto, physical activity (PA) levels declined dramatically at the outset of the COVID-19 pandemic and remained inadequate a year later. Daily PA increased significantly over time, H(10) = 35.506, p < .01, but remained well below the recommended benchmarks for the accrual of positive health and wellness-related outcomes. During the first six months of the pandemic, respondents participating in virtual sport and physical activity programs offered by the facility were significantly more physically active than respondents not participating, H(1) = 8.327, p < .01, with the greatest difference between the two groups seen in May 2020. A larger percentage of individuals maintained adequate levels of PA during the pandemic compared to Canada’s general population of children and youth. These findings are consistent with evidence indicating a strong influence of built environment and other socioeconomic factors on movement behavior among children and youth during the COVID-19 pandemic and provide a unique narrative reflecting the experience of urban youth facing barriers to positive development in Canada’s largest city. © Common Ground Research Networks, Marika Warner, Jackie Robinson, Jennifer Lloyd, Some Rights Reserved.

PROVIDING PHARMACY SUPPORT TO HOUSEBOUND PATIENTS: LEARNING FROM THE COVID-19 PANDEMIC

Introduction: Housebound patients may face challenges to their medicines management due to reduced household mobility and potential lack of access to healthcare services. Previous literature has explored the medication-related needs of housebound patients from pharmacists' perspectives (1-2). However little work has focussed on the patient/family perspective. In this study, we used data obtained from those staying at home as much as possible during the COVID-19 pandemic to fill this gap. Aim: To explore home medicine practices and safety for people who were housebound during the COVID19 pandemic and to create guidance, from the patient/family perspective, for enabling pharmacists to facilitate safe medicine practices for this population. Methods: Interviews were carried out with people who were taking at least one long term medication and met the criteria for ?shielding' and/or were over 70 years of age during the first wave of the COVID-19 pandemic in the UK and/or their family carers. Respondents were recruited through patient and public involvement representatives, the research team's networks, and support groups. Potential participants were approached via personal contact and social media. Interviews were conducted by telephone or video conferencing and participants asked about their medicines management while staying at home. Inductive thematic analysis was carried out. Patient and public involvement representatives were involved in the data analysis alongside the researchers. Results: Fifty people were interviewed (16 males, 34 females;mean age 68 years, range 26-93 years). Interview data suggested diversity of experiences of medicines management while staying at home. Some respondents reported no or little change, others an initial crisis followed by re-stabilisation, and others that the pandemic was a tipping point, exacerbating underlying challenges and having negative effects on their health and wellbeing. Medicine safety issues reported included omitted doses and less-effective formulations being used. Participants also described experiencing high levels of anxiety related to obtaining medicines, monitoring medicines and feeling at risk of contracting COVID-19 while accessing medicine-related healthcare services. Key factors identified as facilitating a smooth transition included patients' own agency, support from family, friends and community, good communication with pharmacy staff, continuity of pharmacy services and synchronisation of medicines supply so that a maximum of one collection/delivery was required each month. Conclusion: The study findings that we have presented relate to the UK only;this may limit the generalisability of our findings to other countries. Findings from Ireland are in the process of being analysed and will provide a basis of comparison. In addition, more females took part than males, despite efforts to address this. However, our findings suggest pharmacy staff can support medicines management for people who are housebound by synchronisation of medicines supply, delivering medicines where possible, developing/raising awareness of alternative means of communication, providing continuity of pharmacy services and signposting any community support available.

A comprehensive, multidisciplinary approach to breast cancer treatment during the COVID-19 pandemic improves time to treatment

A recently published study from the National COVID Cohort Collaborative (N3C) revealed that COVID-19 (CoV) positive status in cancer patients (pts) was associated with an increased risk of all-cause mortality at 1 year when compared to CoV negative status. In addition, age ≥65 years, Southern or Western US residence, an adjusted Charlson Comorbidity Index score ≥4, multi-tumor sites, and recent cytotoxic therapy were associated with increased risk of all-cause mortality. The CoV pandemic significantly impacted our hospital's operations in 03/2020. Regardless, the hospital remained operational for cancer pts through the entire pandemic. The objective of this study is to investigate the impact of CoV pandemic on breast cancer (BC) treatment and outcomes in our academic medical center in East Tennessee. A retrospective cohort group was identified from a prospectively monitored Cancer Registry database of 706 pts comparing those diagnosed with BC from 3/1/2019-12/31/2019 (G1=406 pts) to those diagnosed from 3/1/2020-12/31/2020 (G2=300 pts). The impact of CoV pandemic was studied utilizing SPSS statistical software. During the pandemic, 26% fewer pts were treated for BC in our hospital, likely resulting from decreased screening rates. Pts in G2 were significantly younger than in G1 (mean age 61.4 vs 63.5), but no difference was observed in racial and insurance status or diagnosis with invasive BC vs DCIS (Table 1). CoV test results for 20 pts from G1 and all 300 pts in G2 (Table 2) were analyzed. Only 8 pts (2.6%) tested positive for CoV (all in G2). For 5 of these 8 pts, CoV positivity had no impact on their care or survival, since CoV infection happened either before or after their BC diagnosis and therapy. CoV caused delay of the first course of treatment in 9/300 (3%) G2 pts: 3/9 delays were due to CoV infection and 6/9 delays were due to implementation of nation-wide CoV pandemic guidelines for care of BC pts. Of the 6/9 pts who experienced delayed treatment, 5 were diagnosed with BC in 03/2020 and 1 in 06/2020, all in the time period of the national "lock-down". Delayed surgical treatment had no impact on patient outcomes. During the pandemic, the number of days from diagnosis to chemotherapy or hormonal treatment was significantly shorter (p<0.05) in the G2 cohort than in the pre-pandemic G1 cohort. The number of days to surgery or radiation treatment although non-significant was also lower in the G2 cohort. CoV did not impact readmission to our hospital within 30 days of surgery. None of the BC pts died from CoV. One-year overall survival of our BC pts was not negatively impacted by the CoV pandemic. Our results show that during the CoV pandemic, BC pts were receiving chemotherapy and hormonal treatment sooner than in the pre-pandemic time, likely due to effective teamwork while implementing national guidelines for triaging and administering neoadjuvant treatment during the pandemic. In contrast to N3C data, CoV pandemic did not negatively impact outcomes or 1-year overall survival in our patients. Future studies will determine if these findings remain at the 5 and 10-year follow-up period.

Glycans for the greater good

Carbohydrates are ubiquitous in nature and present across all kingdoms of life – bacteria, fungi,viruses, yeast, plants, animals and humans. They are essential to many biological processes. However,due to their complexity and heterogeneous nature they are often neglected, sometimes referred toas the ‘dark matter’ of biology. Nevertheless, due to their extensive biological impact on health anddisease, glycans and the field of glycobiology have become increasingly popular in recent years, givingrise to glycan-baseddrug development and therapeutics. Forecasting of communicable diseasespredicts that we will see an increase in pandemics of humans and livestock due to global loss ofbiodiversity from changes to land use, intensification of agriculture, climate change and disruption ofecosystems. As such, the development of point-of-caredevices to detect pathogens is vital to preventthe transmission of infectious disease, as we have seen with the COVID-19pandemic. So, can glycansbe exploited to detect COVID-19and other infectious diseases? And is this technology sensitive andaccurate? Here, I discuss the structure and function of glycans, the current glycan-basedtherapeuticsand how glycan binding can be exploited for detection of infectious disease, like COVID-19 © The Authors. Published b 52 y Portland Press Limited under the Creative Commons Attribution License 4.0 (CC BY-NC-ND)

Mucociliary Transport Deficiency and Disease Progression in Syrian Hamsters with SARS-CoV-2 Infection (preprint)

Substantial clinical evidence supports the notion that ciliary function in the airways plays an important role in COVID-19 pathogenesis. Although ciliary damage has been observed in both in vitro and in vivo models, consequent impaired mucociliary transport (MCT) remains unknown for the intact MCT apparatus from an in vivo model of disease. Using golden Syrian hamsters, a common animal model that recapitulates human COVID-19, we quantitatively followed the time course of physiological, virological, and pathological changes upon SARS-CoV-2 infection, as well as the deficiency of the MCT apparatus using micro-optical coherence tomography, a novel method to visualize and simultaneously quantitate multiple aspects of the functional microanatomy of intact airways. Corresponding to progressive weight loss up to 7 days post- infection (dpi), viral detection and histopathological analysis in both the trachea and lung revealed steadily descending infection from the upper airways, as the main target of viral invasion, to lower airways and parenchymal lung, which are likely injured through indirect mechanisms. SARS-CoV-2 infection caused a 67% decrease in MCT rate as early as 2 dpi, largely due to diminished motile ciliation coverage, but not airway surface liquid depth, periciliary liquid depth, or cilia beat frequency of residual motile cilia. Further analysis indicated that the fewer motile cilia combined with abnormal ciliary motion of residual cilia contributed to the delayed MCT. The time course of physiological, virological, and pathological progression suggest that functional deficits of the MCT apparatus predispose to COVID-19 pathogenesis by extending viral retention and may be a risk factor for secondary infection. As a consequence, therapies directed towards the MCT apparatus deserve further investigation as a treatment modality.

Understanding the impact of COVID-19 on healthcare for medically-complex children and youth

BACKGROUND: COVID-19 and associated pandemic measures have disproportionately affected already vulnerable populations, including medically-complex children and youth. In Canada, about one percent of children and youth aged 0 to 18 years (inclusive) are medically complex, which is characterized by having complex, chronic conditions that require specialized care, high healthcare service usage, and functional dependence. In addition to being high users of formal healthcare services, it is estimated that parents spent an average of 52 hours per week providing unpaid care. OBJECTIVES: As part of a larger study exploring the effect of the pandemic on these children and their families, the impact on healthcare usage by this population was investigated. DESIGN/METHODS: In August 2020, a web-based cross-sectional survey was conducted with parents of medically-complex children and youth in British Columbia, Canada. A convenience sample was recruited through posting advertisements on social media platforms, word of mouth, and amplifying the study via the media. The survey, co-created with parent co-researchers, was comprised of 93 questions. It was divided into three sections that focused on pre-and post-pandemic questions about a) medically complex child(ren), b) family/household/community characteristics, and c) respondent demographics. Data were analyzed using descriptive statistics. RESULTS: Results illustrate the largely negative impact of the pandemic on this population's healthcare usage. The survey was completed by 156 parents, mainly mothers (92.3%) who reported information for 188 medically complex children and youth. The children ranged in age from 0 to 18 years, with an average age of 9.5 years, and 58.0% were boys. Between February and August 2020, 30.3% of children had visited the emergency department and the same percentage had parents who avoided taking them in circumstances where they typically would have. 36.2% of the children had been admitted to hospital during that period. The children typically saw an average of four medical specialists and during the pandemic 63.8% had a specialist appointment cancelled or postponed by the clinic. During this time, there was also a steep decline or stoppage of all allied health therapies. CONCLUSION: These results demonstrate a lack of pandemic preparedness to ensure continuity of services. Consequently, medically complex children and youth may be missing key interventions to address ongoing health issues and maintain functional abilities. More proactive planning and coordination are needed to ensure that future situations will not lead to lack of access or therapy for this vulnerable group.

Experiences of diagnostic radiographers through the Covid-19 pandemic.

INTRODUCTION: Diagnostic Radiography plays a major role in the diagnosis and management of patients with Covid-19. This has seen an increase in the demand for imaging services, putting pressure on the workforce. Diagnostic radiographers, as with many other healthcare professions, have been on the frontline, dealing with an unprecedented situation. This research aimed to explore the experience of diagnostic radiographers working clinically during the Covid-19 pandemic. METHODS: Influenced by interpretative phenomenology, this study explored the experiences of diagnostic radiographers using virtual focus group interviews as a method of data collection. RESULTS: Data were analysed independently by four researchers and five themes emerged from the data. Adapting to new ways of working, feelings and emotions, support mechanisms, self-protection and resilience, and professional recognition. CONCLUSION: The adaptability of radiographers came across strongly in this study. Anxieties attributed to the provision of personal protective equipment (PPE), fear of contracting the virus and spreading it to family members were evident. The resilience of radiographers working throughout this pandemic came across strongly throughout this study. A significant factor for coping has been peer support from colleagues within the workplace. The study highlighted the lack of understanding of the role of the radiographer and how the profession is perceived by other health care professionals. IMPLICATIONS FOR PRACTICE: This study highlights the importance of interprofessional working and that further work is required in the promotion of the profession.

Randomized trial of remote cancer symptom monitoring during COVID-19: Impact on symptoms, QoL, and unplanned health care utilization

Background: Unplanned health care utilization due to poorly controlled cancer symptoms is common and important to avoid during the Covid- 19 pandemic. In a randomized trial we evaluated whether remote symptom monitoring and management utilizing Symptom Care at Home (SCH), would reduce symptom burden, improve quality of life, and decrease unplanned health care use in cancer patients receiving active treatment. Methods: Patients (n = 252) receiving chemotherapy and/or radiation therapy were randomized to the SCH intervention (n = 128) or usual care (UC) (n = 124). Daily, those in the intervention group, utilized the SCH system to report the presence and severity of 9 common symptoms during treatment. For symptoms endorsed, SCH participants received immediate, tailored automated self-management coaching. Symptoms at moderate to severe levels were automatically reported to oncology nurse practitioners who called the SCH patients to improve symptom management based on a decision support dashboard. Participants from both groups were assessed at baseline and monthly for up to 5 months on symptom burden (MDASI), mental health well-being and social isolation (PROMIS;HADS) and Health-related Quality of Life (HRQoL) (Penedo Covid-19 HRQoL subscale). Unplanned health care use was extracted from the EHR. Descriptive statistics examined equivalency between groups. Mixed effects models with random intercepts were utilized to examine group differences over time with post-hoc analyses to determine specific timepoint differences. Results: Participants did not differ on demographic or baseline measures. On average participants were 61 years of age, predominantly female (61%) and white (93%). A variety of cancers were represented with colon, breast and ovarian most common and 60% had stage 3 or 4 disease. Longitudinal mixed effects models found significant effects for lower symptom burden (p =.018) and better HRQoL (p =.007) for SCH participants versus UC at months 1 and 2 with improvements subsiding over the remaining months. Mental health wellbeing and social isolation were not significantly different. There were a total of 71 unplanned health care episodes with 28 for SCH and 43 for UC. Unplanned episode types included: unplanned clinic visit- 3 SCH vs 2 UC;ED visit- 10 SCH vs 16 UC and unplanned hospitalizations-15 SCH vs 25 UC. More SCH participants had no unplanned health care episodes than UC participants (χ2 4.08;p =.04). Conclusions: Remote monitoring and management of patients' cancer and treatmentrelated symptoms during the Covid-19 pandemic reduced symptom burden and improved quality of life during the first two months of monitoring. Unplanned health care utilization trended lower for those remotely monitored. Extending care to the home during the pandemic can decrease demand on the health care system and improve cancer patients' symptom experience.