Publications by authors named "Fiona Campbell"

285 Publications

Selenium Supplementation in Pregnancy-Maternal and Newborn Outcomes.

J Nutr Metab 2022 4;2022:4715965. Epub 2022 May 4.

Rowett Institute, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, UK.

Background: Several studies have suggested that increased oxidative stress during pregnancy may be associated with adverse maternal and foetal outcomes. As selenium is an essential mineral with an antioxidant role, our aim was to perform a systematic review of the existing literature reporting the effects of selenium supplementation during pregnancy on maternal and neonatal outcomes.

Materials And Methods: Six electronic databases (Medline, Embase, Cochrane Library, Web of Science, Scopus, and PubMed) were searched for studies reporting the effects of selenium supplementation during pregnancy and the postpartum period on maternal and neonatal outcomes. Only randomised controlled trials on human subjects reported in English and published up to October 2021 were included. Quality assessments were conducted using the modified Downs and Black quality assessment tool. Data were extracted using a narrative synthesis.

Results: Twenty-two articles were included in our systematic review (seventeen reported on maternal outcomes, two on newborn outcomes, and three on both). Maternal studies reported the effects of selenium supplementation in the prevention of thyroid dysfunction, gestational diabetes, pregnancy-induced hypertension/preeclampsia, oxidative stress, postpartum depression, premature rupture of membranes, intrauterine growth retardation, breastmilk composition, and HIV-positive women. Newborn studies reported the effects of maternal selenium supplementation on foetal oxidation stress, foetal lipid profile, neonatal hyperbilirubinemia, and newborn outcomes in HIV-positive mothers. The majority of studies were inappropriately designed to establish clinical or scientific utility. Of interest, four studies reported that selenium supplementation reduced the incidence of thyroid dysfunction and permanent hypothyroidism during the postpartum period by reducing thyroid peroxidase and thyroglobulin antibody titres.

Conclusion: The evidence supporting selenium supplementation during pregnancy is poor and there is a need for appropriately designed randomised controlled trials before routine use can be recommended.
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http://dx.doi.org/10.1155/2022/4715965DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9095401PMC
May 2022

Interventions for the prevention of spontaneous preterm birth: a scoping review of systematic reviews.

BMJ Open 2022 May 13;12(5):e052576. Epub 2022 May 13.

Department of Oncology and Metabolism, The University of Sheffield, Sheffield, UK.

Background: Globally, 11% of babies are born preterm each year. Preterm birth (PTB) is a leading cause of neonatal death and under-five mortality and morbidity, with lifelong sequelae in those who survive. PTB disproportionately impacts low/middle-income countries (LMICs) where the burden is highest.

Objectives: This scoping review sought to the evidence for interventions that reduce the risk of PTB, focusing on the evidence from LMICs and describing how context is considered in evidence synthesis.

Design: We conducted a scoping review, to describe this wide topic area. We searched five electronic databases (2009-2020) and contacted experts to identify relevant systematic reviews of interventions to reduce the risk of PTB. We included published systematic reviews that examined the effectiveness of interventions and their effect on reducing the risk of PTB. Data were extracted and is described narratively.

Results: 139 published systematic reviews were included in the review. Interventions were categorised as primary or secondary. The interventions where the results showed a greater effect size and consistency across review findings included treatment of syphilis and vaginal candidiasis, vitamin D supplementation and cervical cerclage. Included in the 139 reviews were 1372 unique primary source studies. 28% primary studies were undertaken in LMIC contexts and only 4.5% undertaken in a low-income country (LIC) Only 10.8% of the reviews sought to explore the impact of context on findings, and 19.4% reviews did not report the settings or the primary studies.

Conclusion: This scoping review highlights the lack of research evidence derived from contexts where the burden of PTB globally is greatest. The lack of rigour in addressing contextual applicability within systematic review methods is also highlighted. This presents a risk of inappropriate and unsafe recommendations for practice within these contexts. It also highlights a need for primary research, developing and testing interventions in LIC settings.
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http://dx.doi.org/10.1136/bmjopen-2021-052576DOI Listing
May 2022

Parents' views about healthcare professionals having real-time remote access to their young child's diabetes data: qualitative study.

Pediatr Diabetes 2022 May 13. Epub 2022 May 13.

Usher Institute, University of Edinburgh, Edinburgh, UK.

Objectives: We explored parents' views about healthcare professionals having remote access to their young child's insulin and glucose data during a clinical trial to inform use of data sharing in routine paediatric diabetes care.

Methods: Interviews with 33 parents of 30 children (aged 1-7 years) with type 1 diabetes participating in a randomised trial (KidsAP02) comparing hybrid closed-loop system use with sensor-augmented pump therapy. Data were analysed using a qualitative descriptive approach.

Results: Parents reported multiple benefits to healthcare professionals being able to remotely access their child's glucose and insulin data during the trial, despite some initial concerns regarding the insights offered into everyday family life. Key benefits included: less work uploading/sharing data; improved consultations; and, better clinical input and support from healthcare professionals between consultations. Parents noted how healthcare professionals' real-time data access facilitated remote delivery of consultations during the Covid-19 pandemic, and how these were more suitable for young children than face-to-face appointments. Parents endorsed use of real-time data sharing in routine clinical care, subject to caveats regarding data access, security and privacy. They also proposed that, if data sharing were used, consultations for closed-loop system users in routine clinical care could be replaced with needs-driven, ad-hoc contact.

Conclusions: Real-time data sharing can offer clinical, logistical and quality-of-life benefits and enhance opportunities for remote consultations, which may be more appropriate for young children. Wider rollout would require consideration of ethical and cybersecurity issues and, given the heightened intrusion on families' privacy, a non-judgemental, collaborative approach by healthcare professionals. This article is protected by copyright. All rights reserved.
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http://dx.doi.org/10.1111/pedi.13363DOI Listing
May 2022

Don't judge a book by its cover: Exploring low self-reported distress and repressive coping in a pediatric chronic pain population.

J Child Health Care 2022 May 2:13674935221096925. Epub 2022 May 2.

Department of Anesthesia and Pain Medicine, 7979The Hospital for Sick Children, Toronto, ON, Canada.

Repression has been linked to greater illness, somatic symptoms, and poorer physical health, both in adult and pediatric populations. The current study examined psychological and pain profiles of children with chronic pain who may under-report levels of psychological distress at a first interdisciplinary chronic pain assessment. Children and their caregiver completed measures of psychopathology and pain intensity, while clinicians rated their levels of disability. Based on self-report measures, children were classified as "repressors" (low anxiety/high social desirability) or as "true low anxious" (low anxiety/low social desirability). Groups were then compared on psychological and pain characteristics. Compared to children with true low anxiety, repressors reported lower levels of depressive and somatic symptoms but provided higher ratings on pain intensity, pain-unpleasantness, and self-oriented perfectionism. Caregivers of repressors rated their children as having higher levels of adaptability compared to caregivers of children in the true low anxious group. Groups did not differ on clinician-rated level of disability. Children classified as repressors exhibited different profiles than children classified as having true low anxiety on both psychological outcomes and pain characteristics. Repression may be an important factor to consider for those assessing and treating children with chronic pain.
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http://dx.doi.org/10.1177/13674935221096925DOI Listing
May 2022

Parents' experiences of using a hybrid closed-loop system (CamAPS FX) to care for a very young child with type 1 diabetes: Qualitative study.

Diabetes Res Clin Pract 2022 Apr 22;187:109877. Epub 2022 Apr 22.

Usher Institute, Medical School, University of Edinburgh, Edinburgh, UK.

Aims: To explore parents' experiences of using a hybrid closed-loop system (CamAPS FX) when caring for a very young child (aged 1-7 years) with type 1 diabetes.

Methods: Interviews with n = 33 parents of 30 children who used the system during a randomised controlled trial. Data analysis used a descriptive thematic approach.

Results: While some parents were initially reticent about handing control to the system, all reported clinical benefits to using the technology, having to do less diabetes-related work and needing less clinical input over time. Parents welcomed opportunities to enhance the system's efficacy (using Ease-off and Boost functions) as required. Parents described how the system's automated glucose control facilitated more normality, including sleeping better, worrying less about their child, and feeling more confident and able to outsource care. Parents also described more normality for the child (alongside better sleep, mood and concentration, and lessened distress) and siblings. Parents liked being able to administer insulin using a smartphone, but suggested refinements to device size and functionality.

Conclusions: Using a hybrid closed-loop system in very young children can facilitate greater normality and may result in a lessened demand for health professionals' input. Systems may need to be customised for very young children.
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http://dx.doi.org/10.1016/j.diabres.2022.109877DOI Listing
April 2022

Partnering with Youth and Parents for the Greatest Impact of Top Patient-Oriented Priorities in Pediatric Chronic Pain Research, Care and Policy.

Healthc Q 2022 Apr;24(SP):18-23

A senior scientist at The Hospital for Sick Children and a professor at the University of Toronto in Toronto, ON. Jennifer is a nurse practitioner and nurse clinician scientist.

Our original patient-oriented research project identified the top 10 priorities for pediatric chronic pain research and care in Canada from the perspective of people with lived experience (patients), their family members and healthcare professionals through a modified James Lind Alliance Priority Setting Partnership. We undertook subsequent knowledge translation activities with youth, families, healthcare professionals, decision makers and researchers to (1) generate awareness and interest in the top 10 priorities and our partnership process, (2) facilitate collaborative dialogue and open innovation and (3) integrate and adopt the top 10 priorities into stakeholder activities. This paper describes our knowledge translation activities, outcomes and impact.
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http://dx.doi.org/10.12927/hcq.2022.26779DOI Listing
April 2022

Prophylactic internal fixation of the scaphoid to treat impending stress fracture in an athlete.

J Hand Surg Eur Vol 2022 Apr 11:17531934221093289. Epub 2022 Apr 11.

Spire Leeds Hospital, Leeds, UK.

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http://dx.doi.org/10.1177/17531934221093289DOI Listing
April 2022

Parents' experiences of using remote monitoring technology to manage type 1 diabetes in very young children during a clinical trial: Qualitative study.

Diabet Med 2022 Mar 11:e14828. Epub 2022 Mar 11.

Usher Institute, University of Edinburgh, Edinburgh, UK.

Aims: To explore parents' experiences of using remote monitoring technology when caring for a very young child with type 1 diabetes during a clinical trial.

Methods: Interviews were conducted with parents of 30 children (aged 1-7 years) participating in a trial (the KidsAP02 study) comparing hybrid closed-loop insulin delivery with sensor-augmented pump therapy. In both arms, parents had access to remote monitoring technology. Data analysis focused on identification of descriptive themes.

Results: Remote monitoring technology gave parents improved access to data which helped them pre-empt and manage glucose excursions. Parents observed how, when children were in their own care, they could be more absent while present, as their attention could shift to non-diabetes-related activities. Conversely, when children were others' care, remote monitoring enabled parents to be present while absent, by facilitating oversight and collaboration with caregivers. Parents described how remote monitoring made them feel more confident allowing others to care for their children. Parents' confidence increased when using a hybrid closed-loop system, as less work was required to keep glucose in range. Benefits to children were also highlighted, including being able to play and sleep uninterrupted and attend parties and sleepovers without their parents. While most parents welcomed the increased sense of control remote monitoring offered, some noted downsides, such as lack of respite from caregiving responsibilities.

Conclusions: Remote monitoring can offer manifold benefits to both parents and very young children with type 1 diabetes. Some parents, however, may profit from opportunities to take 'time out'.
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http://dx.doi.org/10.1111/dme.14828DOI Listing
March 2022

Cambridge hybrid closed-loop algorithm in children and adolescents with type 1 diabetes: a multicentre 6-month randomised controlled trial.

Lancet Digit Health 2022 04 7;4(4):e245-e255. Epub 2022 Mar 7.

Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Department of Paediatrics, University of Cambridge, Cambridge, UK. Electronic address:

Background: Closed-loop insulin delivery systems have the potential to address suboptimal glucose control in children and adolescents with type 1 diabetes. We compared safety and efficacy of the Cambridge hybrid closed-loop algorithm with usual care over 6 months in this population.

Methods: In a multicentre, multinational, parallel randomised controlled trial, participants aged 6-18 years using insulin pump therapy were recruited at seven UK and five US paediatric diabetes centres. Key inclusion criteria were diagnosis of type 1 diabetes for at least 12 months, insulin pump therapy for at least 3 months, and screening HbA levels between 53 and 86 mmol/mol (7·0-10·0%). Using block randomisation and central randomisation software, we randomly assigned participants to either closed-loop insulin delivery (closed-loop group) or to usual care with insulin pump therapy (control group) for 6 months. Randomisation was stratified at each centre by local baseline HbA. The Cambridge closed-loop algorithm running on a smartphone was used with either (1) a modified Medtronic 640G pump, Medtronic Guardian 3 sensor, and Medtronic prototype phone enclosure (FlorenceM configuration), or (2) a Sooil Dana RS pump and Dexcom G6 sensor (CamAPS FX configuration). The primary endpoint was change in HbA at 6 months combining data from both configurations. The primary analysis was done in all randomised patients (intention to treat). Trial registration ClinicalTrials.gov, NCT02925299.

Findings: Of 147 people initially screened, 133 participants (mean age 13·0 years [SD 2·8]; 57% female, 43% male) were randomly assigned to either the closed-loop group (n=65) or the control group (n=68). Mean baseline HbA was 8·2% (SD 0·7) in the closed-loop group and 8·3% (0·7) in the control group. At 6 months, HbA was lower in the closed-loop group than in the control group (between-group difference -3·5 mmol/mol (95% CI -6·5 to -0·5 [-0·32 percentage points, -0·59 to -0·04]; p=0·023). Closed-loop usage was low with FlorenceM due to failing phone enclosures (median 40% [IQR 26-53]), but consistently high with CamAPS FX (93% [88-96]), impacting efficacy. A total of 155 adverse events occurred after randomisation (67 in the closed-loop group, 88 in the control group), including seven severe hypoglycaemia events (four in the closed-loop group, three in the control group), two diabetic ketoacidosis events (both in the closed-loop group), and two non-treatment-related serious adverse events. There were 23 reportable hyperglycaemia events (11 in the closed-loop group, 12 in the control group), which did not meet criteria for diabetic ketoacidosis.

Interpretation: The Cambridge hybrid closed-loop algorithm had an acceptable safety profile, and improved glycaemic control in children and adolescents with type 1 diabetes. To ensure optimal efficacy of the closed-loop system, usage needs to be consistently high, as demonstrated with CamAPS FX.

Funding: National Institute of Diabetes and Digestive and Kidney Diseases.
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http://dx.doi.org/10.1016/S2589-7500(22)00020-6DOI Listing
April 2022

Qualitative evidence syntheses of attitudes and preferences to inform guidelines on infant feeding in the context of Ebola Virus Disease (EVD) transmission risk.

PLoS Negl Trop Dis 2022 03 10;16(3):e0010080. Epub 2022 Mar 10.

Institute of Population Health Sciences, Queen Mary, University of London, London, United Kingdom.

Background: Breast-feeding holds considerable potential to reduce infant mortality. Feeding choices, already complex, take on additional complexity against a backdrop of the risk of transmissible Ebola Virus. This review describes the factors that influence infant feeding and attitudes of pregnant women, mothers, family members and health practitioners, policy makers and providers (midwives) concerning infant feeding when there is a risk of Mother-to-Child (MTC) transmission of Ebola Virus Disease (EVD).

Methodology: A systematic review of qualitative studies identified through rigorous searches of thirteen online databases and additional citation searches of included studies was undertaken. Search terms included breast-feeding, breast-feeding, infant feeding; Ebola; and qualitative, interview(s) and findings. Independent extraction of data by two reviewers using predefined extraction forms. Studies were assessed using the CASP Qualitative checklist.

Principal Findings: 5219 references were screened. 38 references related specifically to Ebola, and five papers met the inclusion criteria with data gathered from two settings: Guinea and Sierra Leone. The EVD outbreak had a significant impact on beliefs, attitudes, and resources to support infant feeding practices negatively affecting the nutritional status of children. The evidence from these studies highlight the need for guidance and appropriate psychosocial support need to be available to mothers who display symptoms and become infected and to front-line staff who are giving advice. Communities need to be engaged because stigma and fear may hinder uptake of appropriate interventions. The EVD outbreak caused multi-level system disruption akin to that seen following a natural disaster, meaning that logistics and coordination are critical and need adequate resourcing. Food production and distribution, and malnutrition screening are also disrupted and thereby compounding compromised nutritional status. The limited number of relevant studies highlights the need for further primary research, particularly in translation of messages to local settings.

Conclusions: An EVD outbreak causes multi-level disruption that negatively impacts infant feeding and child care practices. Negative impacts have multiple causes and successful planning for Ebola outbreaks requires that nutrition of infants and young children is a priority. Lessons from the Ebola pandemic have wider applicability to other pandemic contexts including Covid-19.
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http://dx.doi.org/10.1371/journal.pntd.0010080DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8959176PMC
March 2022

Experiences of Pediatric Pain Professionals Providing Care during the COVID-19 Pandemic: A Qualitative Study.

Children (Basel) 2022 Feb 9;9(2). Epub 2022 Feb 9.

Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, ON M5G 0A4, Canada.

Chronic pain affects 1 in 5 youth, many of whom manage their pain using a biopsychosocial approach. The COVID-19 pandemic has impacted the way that healthcare is delivered. As part of a larger program of research, this study aimed to understand the impact of the pandemic on pediatric chronic pain care delivery including impact on patients' outcomes, from the perspective of pediatric healthcare providers. A qualitative descriptive study design was used and 21 healthcare providers from various professional roles, clinical settings, and geographic locations across Canada were interviewed. Using a reflexive thematic analysis approach 3 themes were developed: (1) duality of pandemic impact on youth with chronic pain (i.e., how the pandemic influenced self-management while also exacerbating existing socioeconomic inequalities); (2) changes to the healthcare system and clinical practices (i.e., triaging and access to care); (3) shift to virtual care (i.e., role of institutions and hybrid models of care). These findings outline provider perspectives on the positive and negative impacts of the pandemic on youth with chronic pain and highlight the role of socioeconomic status and access to care in relation to chronic pain management during the pandemic in a high-income country with a publicly funded healthcare system.
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http://dx.doi.org/10.3390/children9020230DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8870259PMC
February 2022

The ScHARR LMIC filter: Adapting a low- and middle-income countries geographic search filter to identify studies on preterm birth prevention and management.

Res Synth Methods 2022 Feb 10. Epub 2022 Feb 10.

School of Health and Related Research, The University of Sheffield, Sheffield, UK.

Search filters are used to find evidence on specific subjects. Performance of filters can be varied and may need adapting to meet the needs of research topics. There are limited geographic search filters available, and only one pertaining to low- and middle-income countries (LMICs). When searching for literature on preterm birth prevention and management in LMICs for a research project at the School of Health and Related Research (ScHARR), we made use of the Cochrane Effective Practice and Organisation of Care (EPOC) LMIC geographic search filter for the databases; Ovid MEDLINE, Ovid Embase, Cochrane Library. During screening following a broad scoping search in Ovid MEDLINE, it was found that the EPOC LMIC filter did not identify a relevant study. Adaptations were made to the LMIC geographic search filter to maximise retrieval and identify the missing study. Institution was included as a search field, and the search terms high burden or countdown countries were added. The filter was translated for the databases; Ovid Embase, Cochrane Library, Ovid PsycINFO, and CINAHL via EBSCO. The adapted ScHARR LMIC filter is a non-validated 1st generation filter which increases the sensitivity of the EPOC LMIC search filter. Validating the filter would confirm its retrieval performance and benefit information professionals, researchers, and health professionals. We recommend that the ScHARR LMIC filter is used to improve sensitivity of the Cochrane EPOC LMIC filter and reduce the risk of missing relevant studies.
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http://dx.doi.org/10.1002/jrsm.1552DOI Listing
February 2022

Association of British Clinical Diabetologists, Diabetes Technology Network UK and Association of Children's Diabetes Clinicians Survey of UK Healthcare Professional Attitudes Towards Open-Source Automated Insulin Delivery Systems.

Diabetes Ther 2022 Feb 31;13(2):341-353. Epub 2022 Jan 31.

Department of Diabetes, School of Life Course Sciences, King's College London, London, UK.

Introduction: Automated insulin delivery (AID) systems can enable improved glycaemic outcomes with reduced mental burden. Open-source AID (OS-AID) systems overcome some of the developmental and access barriers enabling a wider use of these systems. Limited data are available on healthcare professional (HCP) opinions and current practice regarding these systems. The aim of this survey was to gain insight into HCP perceptions and practices around OS-AID.

Methods: This survey was developed collaboratively with OS-AID users and distributed to adult and children's teams, using an online survey tool. Results were received between February and April 2019. Responses were assessed using simple descriptive statistics with analyses stratified by respondent characteristics.

Results: 317 responses were obtained from a range of HCPs in both adult and paediatric services. Key results include: HCP perception of OS-AID as "risky in the wrong hands" (43%); 91% felt uncomfortable initiating discussions around OS-AID because of lack of regulation (67%) and/or their own lack of knowledge (63%). Half of HCPs (47%) reported that they would choose OS-AID if they themselves had type 1 diabetes.

Conclusions: HCPs are generally supportive of OS-AID users but many feel uncomfortable with the technicalities of the systems given the lack of approval. Knowledge around the use of these systems was limited. Re-assessment of HCP perceptions should be performed in the future given the evolving landscape of diabetes technology, recent consensus statements and emerging ethical and legal perspectives.
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http://dx.doi.org/10.1007/s13300-022-01203-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8873338PMC
February 2022

Patients with presumed tuberculosis in sub-Saharan Africa that are not diagnosed with tuberculosis: a systematic review and meta-analysis.

Thorax 2022 Jan 24. Epub 2022 Jan 24.

Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.

Background: Many patients in sub-Saharan Africa whom a diagnosis of tuberculosis is considered are subsequently not diagnosed with tuberculosis. The proportion of patients this represents, and their alternative diagnoses, have not previously been systematically reviewed.

Methods: We searched four databases from inception to 27 April 2020, without language restrictions. We included all adult pulmonary tuberculosis diagnostic studies from sub-Saharan Africa, excluding case series and inpatient studies. We extracted the proportion of patients with presumed tuberculosis subsequently not diagnosed with tuberculosis and any alternative diagnoses received. We conducted a random effects meta-analysis to obtain pooled estimates stratified by passive and active case finding.

Results: Our search identified 1799 studies, of which 18 studies (2002-2019) with 14 527 participants from 10 African countries were included. The proportion of patients with presumed tuberculosis subsequently not diagnosed with tuberculosis was 48.5% (95% CI 39.0 to 58.0) in passive and 92.8% (95% CI 85.0 to 96.7) in active case-finding studies. This proportion increased with declining numbers of clinically diagnosed tuberculosis cases. A history of tuberculosis was documented in 55% of studies, with just five out of 18 reporting any alternative diagnoses.

Discussion: Nearly half of all patients with presumed tuberculosis in sub-Saharan Africa do not have a final diagnosis of active tuberculosis. This proportion may be higher when active case-finding strategies are used. Little is known about the healthcare needs of these patients. Research is required to better characterise these patient populations and plan health system solutions that meet their needs.

Prospero Registration Number: CRD42018100004.
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http://dx.doi.org/10.1136/thoraxjnl-2021-217663DOI Listing
January 2022

Randomized Trial of Closed-Loop Control in Very Young Children with Type 1 Diabetes.

N Engl J Med 2022 01;386(3):209-219

From the Wellcome Trust-Medical Research Council (MRC) Institute of Metabolic Science (J.W., J.M.A., C.K.B., M.E.W., R.H.) and the Department of Paediatrics (J.W., M.E.W., A.T., R.H.), University of Cambridge, and the Wolfson Diabetes and Endocrine Clinic, Cambridge University Hospitals NHS Foundation Trust (S.H.), Cambridge, the Department of Paediatric Diabetes, Leeds Children's Hospital, Leeds (F.M.C., J.Y.), and Usher Institute, University of Edinburgh, Edinburgh (J.L.) - all in the United Kingdom; Diabetes and Endocrine Care Clinique Pédiatrique, Clinique Pédiatrique, Centre Hospitalier de Luxembourg, Luxembourg (C.B., U.S.); the Department of Pediatric Endocrinology, Universitair Ziekenhuis Brussel-Vrije Universiteit Brussel, Brussels (C.B.); the Department of Pediatric and Adolescent Medicine (E.F.-R.), and the Division of Endocrinology and Diabetology, Department of Internal Medicine (J.K.M.), Medical University of Graz, Graz, the Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna (B.R.-M., M.T., K.N.), and the Department of Pediatrics I, Medical University of Innsbruck, Innsbruck (S.E.H.) - all in Austria; the Hospital for Children and Adolescents, University of Leipzig, Leipzig, and the Hospital for Children and Adolescents "am Nicolausholz," Bad Kösen - both in Germany (T.M.K.); the Division of Pediatric Endocrinology, Stanford University, Stanford, CA (K.K.H.); Vyoo Agency, Lyon, France (S.R.); and the Jaeb Center for Health Research, Tampa, FL (J.S., L.E.B., C.K.).

Background: The possible advantage of hybrid closed-loop therapy (i.e., artificial pancreas) over sensor-augmented pump therapy in very young children with type 1 diabetes is unclear.

Methods: In this multicenter, randomized, crossover trial, we recruited children 1 to 7 years of age with type 1 diabetes who were receiving insulin-pump therapy at seven centers across Austria, Germany, Luxembourg, and the United Kingdom. Participants received treatment in two 16-week periods, in random order, in which the closed-loop system was compared with sensor-augmented pump therapy (control). The primary end point was the between-treatment difference in the percentage of time that the sensor glucose measurement was in the target range (70 to 180 mg per deciliter) during each 16-week period. The analysis was conducted according to the intention-to-treat principle. Key secondary end points included the percentage of time spent in a hyperglycemic state (glucose level, >180 mg per deciliter), the glycated hemoglobin level, the mean sensor glucose level, and the percentage of time spent in a hypoglycemic state (glucose level, <70 mg per deciliter). Safety was assessed.

Results: A total of 74 participants underwent randomization. The mean (±SD) age of the participants was 5.6±1.6 years, and the baseline glycated hemoglobin level was 7.3±0.7%. The percentage of time with the glucose level in the target range was 8.7 percentage points (95% confidence interval [CI], 7.4 to 9.9) higher during the closed-loop period than during the control period (P<0.001). The mean adjusted difference (closed-loop minus control) in the percentage of time spent in a hyperglycemic state was -8.5 percentage points (95% CI, -9.9 to -7.1), the difference in the glycated hemoglobin level was -0.4 percentage points (95% CI, -0.5 to -0.3), and the difference in the mean sensor glucose level was -12.3 mg per deciliter (95% CI, -14.8 to -9.8) (P<0.001 for all comparisons). The time spent in a hypoglycemic state was similar with the two treatments (P = 0.74). The median time spent in the closed-loop mode was 95% (interquartile range, 92 to 97) over the 16-week closed-loop period. One serious adverse event of severe hypoglycemia occurred during the closed-loop period. One serious adverse event that was deemed to be unrelated to treatment occurred.

Conclusions: A hybrid closed-loop system significantly improved glycemic control in very young children with type 1 diabetes, without increasing the time spent in hypoglycemia. (Funded by the European Commission and others; ClinicalTrials.gov number, NCT03784027.).
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http://dx.doi.org/10.1056/NEJMoa2111673DOI Listing
January 2022

Chemotherapy-induced infiltration of neutrophils promotes pancreatic cancer metastasis via Gas6/AXL signalling axis.

Gut 2022 Jan 12. Epub 2022 Jan 12.

Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, UK

Objective: Pancreatic ductal adenocarcinoma (PDAC) is a highly metastatic disease and cytotoxic chemotherapy is the standard of care treatment for patients with advanced disease. Here, we investigate how the microenvironment in PDAC liver metastases reacts to chemotherapy and its role in metastatic disease progression post-treatment, an area which is poorly understood.

Design: The impact of chemotherapy on metastatic disease progression and immune cell infiltrates was characterised using flow and mass cytometry combined with transcriptional and histopathological analysis in experimental PDAC liver metastases mouse models. Findings were validated in patient derived liver metastases and in an autochthonous PDAC mouse model. Human and murine primary cell cocultures and ex vivo patient-derived liver explants were deployed to gain mechanistical insights on whether and how chemotherapy affects the metastatic tumour microenvironment.

Results: We show that in vivo, chemotherapy induces an initial infiltration of proinflammatory macrophages into the liver and activates cytotoxic T cells, leading only to a temporary restraining of metastatic disease progression. However, after stopping treatment, neutrophils are recruited to the metastatic liver via CXCL1 and 2 secretion by metastatic tumour cells. These neutrophils express growth arrest specific 6 (Gas6) which leads to AXL receptor activation on tumour cells enabling their regrowth. Disruption of neutrophil infiltration or inhibition of the Gas6/AXL signalling axis in combination with chemotherapy inhibits metastatic growth. Chemotherapy increases Gas6 expression in circulating neutrophils from patients with metastatic pancreatic cancer and recombinant Gas6 is sufficient to promote tumour cell proliferation ex vivo, in patient-derived metastatic liver explants.

Conclusion: Combining chemotherapy with Gas6/AXL or neutrophil targeted therapy could provide a therapeutic benefit for patients with metastatic pancreatic cancer.
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http://dx.doi.org/10.1136/gutjnl-2021-325272DOI Listing
January 2022

hENT1 Predicts Benefit from Gemcitabine in Pancreatic Cancer but Only with Low CDA mRNA.

Cancers (Basel) 2021 Nov 17;13(22). Epub 2021 Nov 17.

Liverpool Experimental Cancer Medicine Centre, 2nd Floor Sherrington Building, Ashton St, University of Liverpool, Liverpool L69 3GE, UK.

Gemcitabine or 5-fluorouracil (5-FU) based treatments can be selected for pancreatic cancer. Equilibrative nucleoside transporter 1 (hENT1) predicts adjuvant gemcitabine treatment benefit over 5-FU. Cytidine deaminase (CDA), inside or outside of the cancer cell, will deaminate gemcitabine, altering transporter affinity. ESPAC-3(v2) was a pancreatic cancer trial comparing adjuvant gemcitabine and 5-FU. Tissue microarray sections underwent in situ hybridization and immunohistochemistry. Analysis of both CDA and hENT1 was possible with 277 patients. The transcript did not correlate with protein levels for either marker. High hENT1 protein was prognostic with gemcitabine; median overall survival was 26.0 v 16.8 months ( 0.006). Low CDA transcript was prognostic regardless of arm; 24.8 v 21.2 months with gemcitabine ( 0.02) and 26.4 v 14.6 months with 5-FU ( 0.02). Patients with low hENT1 protein did better with 5-FU, but only if the CDA transcript was low (median survival of 5-FU v gemcitabine; 29.3 v 18.3 months, compared with 14.2 v 14.6 with high CDA). CDA mRNA is an independent prognostic biomarker. When added to hENT1 protein status, it may also provide treatment-specific predictive information and, within the frame of a personalized treatment strategy, guide to either gemcitabine or 5FU for the individual patient.
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http://dx.doi.org/10.3390/cancers13225758DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8616255PMC
November 2021

Safety, tolerability and antiviral activity of the antisense oligonucleotide bepirovirsen in patients with chronic hepatitis B: a phase 2 randomized controlled trial.

Nat Med 2021 10 12;27(10):1725-1734. Epub 2021 Oct 12.

Ionis Pharmaceuticals Inc, Carlsbad, CA, USA.

Chronic infection with hepatitis B virus (HBV) leads to an increased risk of death from cirrhosis and hepatocellular carcinoma. Functional cure rates are low with current treatment options (nucleos(t)ide analogs (NAs) and pegylated interferons). Bepirovirsen is an antisense oligonucleotide targeting all HBV messenger RNAs; in cell culture and animal models, bepirovirsen leads to reductions in HBV-derived RNAs, HBV DNA and viral proteins. This phase 2 double-blinded, randomized, placebo-controlled trial is the first evaluation of the safety and activity of an antisense oligonucleotide targeting HBV RNA in both treatment-naïve and virally suppressed individuals with chronic HBV infection. The primary objective was to assess the safety and tolerability of bepirovirsen in individuals with chronic hepatitis B (CHB) (NCT02981602). The secondary objective was to assess antiviral activity, including the change from baseline to day 29 in serum hepatitis B surface antigen (HBsAg) concentration. Participants with CHB infection ≥6 months and serum HBsAg ≥50 IU ml were enrolled from seven centers across Hong Kong and the Republic of Korea and randomized (3:1 within each dose cohort) to receive bepirovirsen or placebo via subcutaneous injection twice weekly during weeks 1 and 2 (days 1, 4, 8 and 11) and once weekly during weeks 3 and 4 (days 15 and 22). Participants were then followed for 26 weeks. Twenty-four participants were treatment-naïve and seven were receiving stable NA therapy. Treatment-emergent adverse events were mostly mild/moderate (most commonly injection site reactions). Eleven (61.1%) and three (50.0%) treatment-naïve participants experienced one or more treatment-emergent adverse event in the bepirovirsen and placebo groups, respectively. In participants receiving NA therapy, the corresponding numbers were three (60.0%) and one (50.0%). Transient, self-resolving alanine aminotransferase flares (≥2× upper limit of normal) were observed in eight treatment-naïve participants and three participants on stable NA regimens in the bepirovirsen treatment arms. HBsAg reductions were observed and were significant versus placebo for treatment-naïve participants receiving bepirovirsen 300 mg (P = 0.001), but not for the bepirovirsen 150 mg group (P = 0.245) or participants receiving stable NA therapy (P = 0.762). Two participants in each of the 300 mg dose groups achieved HBsAg levels below the lower limit of quantitation by day 29 (n = 3) or day 36 (n = 1). Bepirovirsen had a favorable safety profile. These preliminary observations warrant further investigation of the safety and activity of bepirovirsen in a larger CHB patient population.
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http://dx.doi.org/10.1038/s41591-021-01513-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8516644PMC
October 2021

Development of a Screening Tool for Pediatric Neuropathic Pain and Complex Regional Pain Syndrome: Pediatric PainSCAN.

Clin J Pain 2021 10 12;38(1):15-22. Epub 2021 Oct 12.

Institute for Health Policy, Management, & Evaluation.

Objective: Neuropathic pain (NP) and complex regional pain syndrome (CRPS) in children can result in significant disability and emotional distress. Early assessment and treatment could potentially improve pain, function, quality of life, and reduce costs to the health care system. Currently, there are no screening tools for pediatric NP and CRPS. This research aimed to develop and establish the content validity of a screening tool for pediatric NP and CRPS using a phased approach.

Materials And Methods: Phase I surveyed clinical experts using a modified Delphi procedure to elicit disease concepts for inclusion. In phase II, a consensus conference including clinicians, researchers, and people with lived experience, informed the initial item pool. Consensus for item inclusion was achieved using a nominal group technique for voting. Phase III used iterative rounds of cognitive interviews with children aged 8 to 18 years with CRPS or NP to evaluate the tool's comprehensiveness and individual item relevance and comprehensibility. Descriptive statistics were used to describe participant characteristics. Content analysis was used to analyze patient interviews.

Results: Phase I (n=50) generated an initial item pool (22 items). Phase II generated a comprehensive item pool (50 items), after which an initial version of the screening tool was drafted. Following phase III (n=26) after item revision and elimination, 37 items remained.

Discussion: The Pediatric PainSCAN is a novel screening tool that has undergone rigorous development and content validity testing. Further research is needed to conduct item reduction, determine scoring, and test additional measurement properties.
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http://dx.doi.org/10.1097/AJP.0000000000000993DOI Listing
October 2021

Medical cannabis or cannabinoids for chronic pain: a clinical practice guideline.

BMJ 2021 09 8;374:n2040. Epub 2021 Sep 8.

Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.

Clinical Question: What is the role of medical cannabis or cannabinoids for people living with chronic pain due to cancer or non-cancer causes?

Current Practice: Chronic pain is common and distressing and associated with considerable socioeconomic burden globally. Medical cannabis is increasingly used to manage chronic pain, particularly in jurisdictions that have enacted policies to reduce use of opioids; however, existing guideline recommendations are inconsistent, and cannabis remains illegal for therapeutic use in many countries.

Recommendation: The guideline expert panel issued a weak recommendation to offer a trial of non-inhaled medical cannabis or cannabinoids, in addition to standard care and management (if not sufficient), for people living with chronic cancer or non-cancer pain.

How This Guideline Was Created: An international guideline development panel including patients, clinicians with content expertise, and methodologists produced this recommendation in adherence with standards for trustworthy guidelines using the GRADE approach. The MAGIC Evidence Ecosystem Foundation (MAGIC) provided methodological support. The panel applied an individual patient perspective.

The Evidence: This recommendation is informed by a linked series of four systematic reviews summarising the current body of evidence for benefits and harms, as well as patient values and preferences, regarding medical cannabis or cannabinoids for chronic pain.

Understanding The Recommendation: The recommendation is weak because of the close balance between benefits and harms of medical cannabis for chronic pain. It reflects a high value placed on small to very small improvements in self reported pain intensity, physical functioning, and sleep quality, and willingness to accept a small to modest risk of mostly self limited and transient harms. Shared decision making is required to ensure patients make choices that reflect their values and personal context. Further research is warranted and may alter this recommendation.
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http://dx.doi.org/10.1136/bmj.n2040DOI Listing
September 2021

Medical cannabis or cannabinoids for chronic non-cancer and cancer related pain: a systematic review and meta-analysis of randomised clinical trials.

BMJ 2021 09 8;374:n1034. Epub 2021 Sep 8.

Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada.

Objective: To determine the benefits and harms of medical cannabis and cannabinoids for chronic pain.

Design: Systematic review and meta-analysis.

Data Sources: MEDLINE, EMBASE, AMED, PsycInfo, CENTRAL, CINAHL, PubMed, Web of Science, Cannabis-Med, Epistemonikos, and trial registries up to January 2021.

Study Selection: Randomised clinical trials of medical cannabis or cannabinoids versus any non-cannabis control for chronic pain at ≥1 month follow-up.

Data Extraction And Synthesis: Paired reviewers independently assessed risk of bias and extracted data. We performed random-effects models meta-analyses and used GRADE to assess the certainty of evidence.

Results: A total of 32 trials with 5174 adult patients were included, 29 of which compared medical cannabis or cannabinoids with placebo. Medical cannabis was administered orally (n=30) or topically (n=2). Clinical populations included chronic non-cancer pain (n=28) and cancer related pain (n=4). Length of follow-up ranged from 1 to 5.5 months. Compared with placebo, non-inhaled medical cannabis probably results in a small increase in the proportion of patients experiencing at least the minimally important difference (MID) of 1 cm (on a 10 cm visual analogue scale (VAS)) in pain relief (modelled risk difference (RD) of 10% (95% confidence interval 5% to 15%), based on a weighted mean difference (WMD) of -0.50 cm (95% CI -0.75 to -0.25 cm, moderate certainty)). Medical cannabis taken orally results in a very small improvement in physical functioning (4% modelled RD (0.1% to 8%) for achieving at least the MID of 10 points on the 100-point SF-36 physical functioning scale, WMD of 1.67 points (0.03 to 3.31, high certainty)), and a small improvement in sleep quality (6% modelled RD (2% to 9%) for achieving at least the MID of 1 cm on a 10 cm VAS, WMD of -0.35 cm (-0.55 to -0.14 cm, high certainty)). Medical cannabis taken orally does not improve emotional, role, or social functioning (high certainty). Moderate certainty evidence shows that medical cannabis taken orally probably results in a small increased risk of transient cognitive impairment (RD 2% (0.1% to 6%)), vomiting (RD 3% (0.4% to 6%)), drowsiness (RD 5% (2% to 8%)), impaired attention (RD 3% (1% to 8%)), and nausea (RD 5% (2% to 8%)), but not diarrhoea; while high certainty evidence shows greater increased risk of dizziness (RD 9% (5% to 14%)) for trials with <3 months follow-up versus RD 28% (18% to 43%) for trials with ≥3 months follow-up; interaction test P=0.003; moderate credibility of subgroup effect).

Conclusions: Moderate to high certainty evidence shows that non-inhaled medical cannabis or cannabinoids results in a small to very small improvement in pain relief, physical functioning, and sleep quality among patients with chronic pain, along with several transient adverse side effects, compared with placebo. The accompanying Rapid Recommendation provides contextualised guidance based on this body of evidence. SYSTEMATIC REVIEW REGISTRATION: https://osf.io/3pwn2.
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http://dx.doi.org/10.1136/bmj.n1034DOI Listing
September 2021

Psychological Well-Being of Parents of Very Young Children With Type 1 Diabetes - Baseline Assessment.

Front Endocrinol (Lausanne) 2021 12;12:721028. Epub 2021 Aug 12.

Wellcome Trust-Medical Research Council (MRC) Institute of Metabolic Science, University of Cambridge, Cambridge, United Kingdom.

Background: Type 1 diabetes in young children is a heavy parental burden. As part of pilot phase of the KIDSAP01 study, we conducted a baseline assessment in parents to study the association between hypoglycemia fear, parental well-being and child behavior.

Methods: All parents were invited to fill in baseline questionnaires: hypoglycemia fear survey (HFS), WHO-5, Epworth Sleepiness Scale and Strength and Difficulties Questionnaire (SDQ).

Results: 24 children (median age: 5-year, range 1-7 years, 63% male, mean diabetes duration: 3 ± 1.7 years) participated. 23/24 parents filled out the questionnaires. We found a higher score for the hypoglycemia fear behavior 33.9 ± 5.6 compared to hypoglycemia worry 34.6 ± 12.2. Median WHO-5 score was 16 (8 - 22) with poor well-being in two parents. Median daytime sleepiness score was high in five parents (>10). For six children a high total behavioral difficulty score (>16) was reported. Pro social behavior score was lower than normal in six children (<6). Parental well-being was negatively associated with HFS total ( = - 0.50, <.05) and subscale scores ( = - 0.44, <.05 for HFS-Worry and HFS-Behavior), child behavior ( = - 0.45, = .05) and positively with child age and diabetes duration ( = 0.58, <.01, = 0.6, <.01). HFS, parental well-being nor daytime sleepiness are associated with the HbA1c.

Conclusion: Regular screening of parental well-being, hypoglycemia fear and child behavior should be part of routine care to target early intervention.
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http://dx.doi.org/10.3389/fendo.2021.721028DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8397439PMC
February 2022

Dataset for the reporting of carcinoma of the exocrine pancreas: recommendations from the International Collaboration on Cancer Reporting (ICCR).

Histopathology 2021 Dec 22;79(6):902-912. Epub 2021 Sep 22.

Department of Pathology, Microbiology, and Immunology, Vanderbilt University Medical Centre, Nashville, TN, USA.

Aims: Current guidelines for pathology reporting on pancreatic cancer differ in certain aspects, resulting in divergent reporting practices and a lack of comparability of data. Here, we report on a new international dataset for pathology reporting on resection specimens with cancer of the exocrine pancreas (ductal adenocarcinoma and acinar cell carcinoma). The dataset was produced under the auspices of the International Collaboration on Cancer Reporting (ICCR), which is a global alliance of major (inter)national pathology and cancer organisations.

Methods And Results: According to the ICCR's rigorous process for dataset development, an international expert panel consisting of pancreatic pathologists, a pancreatic surgeon and an oncologist produced a set of core and non-core data items based on a critical review and discussion of current evidence. Commentary was provided for each data item to explain the rationale for selecting it as a core or non-core element and its clinical relevance, and to highlight potential areas of disagreement or lack of evidence, in which case a consensus position was formulated. Following international public consultation, the document was finalised and ratified, and the dataset, which includes a synoptic reporting guide, was published on the ICCR website.

Conclusions: This first international dataset for cancer of the exocrine pancreas is intended to promote high-quality, standardised pathology reporting. Its widespread adoption will improve the consistency of reporting, facilitate multidisciplinary communication, and enhance the comparability of data, all of which will help to improve the management of pancreatic cancer patients.
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http://dx.doi.org/10.1111/his.14540DOI Listing
December 2021

COVID-19 Pandemic Impact and Response in Canadian Pediatric Chronic Pain Care: A National Survey of Medical Directors and Pain Professionals.

Can J Pain 2021 30;5(1):139-150. Epub 2021 Jun 30.

The Hospital for Sick Children, Child Health Evaluative Sciences, Toronto, Ontario, Canada.

: The COVID-19 pandemic presents one of the greatest threats to pediatric pain care seen in generations. Due to public health restrictions, many pediatric pain clinics halted in-person appointments, delaying and disrupting access to care. There is no existing research on the impacts of COVID-19 on pediatric chronic pain care in Canada or the challenges experienced by health care professionals and pain clinics. : The aim of this study was to evaluate the impact of COVID-19 on Canadian pediatric chronic pain care by documenting how health care professionals provided care during the first six months of the pandemic. : Two Canadian online cross-sectional surveys were conducted: one among Canadian pediatric pain clinic directors (Study 1) and another among multidisciplinary pediatric pain health care professionals (Study 2). : Responses from 13/13 Canadian pediatric pain clinics/rehabilitation programs indicated that all clinics provided virtual care during the pandemic. No significant changes were reported on the frequency of appointment requests. Most clinics reported no perceived change in patient pain levels ( = 9/13, 69%) or occurrence of pain flares ( = 10/13, 77%). Results from 151 individual health care professionals indicated that the majority (90%) of non-emergency department respondents were providing virtual care. The main challenges of virtual care included technological barriers, financial concerns, infrastructure and logistics, privacy, and clinical challenges. : This study documented the impact of the COVID-19 pandemic on pediatric chronic pain care in Canada and highlighted the rapid shift to using virtual solutions. Simultaneously, respondents outlined current challenges and potential solutions to consider in the development of virtual care guidelines and policy in Canada.
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http://dx.doi.org/10.1080/24740527.2021.1931069DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8253119PMC
June 2021

Adolescents' Experiences of Using a Smartphone Application Hosting a Closed-loop Algorithm to Manage Type 1 Diabetes in Everyday Life: Qualitative Study.

J Diabetes Sci Technol 2021 09 14;15(5):1042-1051. Epub 2021 Jul 14.

Usher Institute, Medical School, University of Edinburgh, UK.

Background: Closed-loop technology may help address health disparities experienced by adolescents, who are more likely to have suboptimal glycemic control than other age groups and, because of their age, find diabetes self-management particularly challenging. The CamAPS FX closed-loop has sought to address accessibility and usability issues reported by users of previous prototype systems. It comprises small components and a smartphone app used to: announce meal-time boluses, adjust ("boost" or "ease-off") closed-loop insulin delivery, customize alarms, and review/share data. We explored how using the CamAPS FX platform influences adolescents' self-management practices and everyday lives.

Methods: Eighteen adolescents were interviewed after having ≥6 months experience using the closed-loop platform. Data were analyzed thematically.

Results: Participants reported feeling less burdened and shackled by diabetes because closed-loop components were easier to carry/wear, finger-pricks were not required, the smartphone app provided a discreet and less stigmatizing way of managing diabetes in public, and they were able to customize alarms. Participants also reported checking and reviewing data more regularly, because they did so when using the smartphone for other reasons. Some reported challenges in school settings where use of personal phones was restricted. Participants highlighted how self-management practices were improved because they could easily review glucose data and adjust closed-loop insulin delivery using the "boost" and "ease-off" functions. Some described how using the system resulted in them forgetting about diabetes and neglecting certain tasks.

Conclusions: A closed-loop system with small components and control algorithm on a smartphone app can enhance usability and acceptability for adolescents and may help address the health-related disparities experienced by this age group. However, challenges can arise from using a medical app on a device which doubles as a smartphone.

Trial Registration: Closed Loop From Onset in Type 1 Diabetes (CLOuD); NCT02871089; https://clinicaltrials.gov/ct2/show/NCT02871089.
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http://dx.doi.org/10.1177/1932296821994201DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8411472PMC
September 2021

Best practices for virtual care to support youth with chronic pain and their families: a rapid systematic review to inform health care and policy during COVID-19 and beyond.

Pain Rep 2021 Jul-Aug;6(2):e935. Epub 2021 Jun 3.

Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, ON, Canada.

The COVID-19 pandemic has acutely challenged health systems and catalyzed the need for widescale virtual care and digital solutions across all areas of health, including pediatric chronic pain. The objective of this rapid systematic review was to identify recommendations, guidelines, and/or best practices for using virtual care to support youth with chronic pain and their families (CRD42020184498). MEDLINE, CINAHL, Embase, APA PsychINFO, and Web of Science were searched the week of May 25, 2020, for English language peer-reviewed articles published since 2010 that (1) discussed children and adolescents aged <18 years reporting any type of chronic pain (ie, pain lasting >3 months); (2) focused on any type of virtual care (eg, telephone, telehealth, telemedicine, mHealth, eHealth, online, or digital); and (3) reported on guidelines, best practices, considerations, or recommendations for virtual care. Abstract and full text screening and data extraction were performed in duplicate. Meta-ethnography was used to synthesize concepts across articles. Of 4161 unique records screened, 16 were included addressing diverse virtual care and pediatric chronic pain conditions. Four key themes were identified: (1) opportunities to better leverage virtual care, (2) direct effective implementation of virtual care, (3) selection of virtual care platforms, and (4) gaps in need of further consideration when using virtual care to support youth with chronic pain and their families. No existing guidelines for virtual care for pediatric chronic pain were identified; however, best practices for virtual care were identified and should be used by health professionals, decision makers, and policymakers in implementing virtual care.
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http://dx.doi.org/10.1097/PR9.0000000000000935DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8177877PMC
June 2021

Rapid Evidence and Gap Map of virtual care solutions across a stepped care continuum for youth with chronic pain and their families in response to the COVID-19 pandemic.

Pain 2021 11;162(11):2658-2668

Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, ON, Canada.

Abstract: Poor access to pediatric chronic pain care is a longstanding concern. The COVID-19 pandemic has necessitated virtual care delivery at an unprecedented pace and scale. We conducted a scoping review to create an interactive Evidence and Gap Map of virtual care solutions across a stepped care continuum (ie, from self-directed to specialist care) for youth with chronic pain and their families. Review methodology was codesigned with 8 youth with chronic pain and 7 parents/caregivers. Data sources included peer-reviewed scientific literature, gray literature (app stores and web sites), and a call for innovations. Records were independently coded and assessed for quality. Overall, 185 records were included (105 scientific records, 56 apps, 16 web sites, and 8 innovations). Most virtual care solutions were applicable across pediatric chronic pain diagnoses, with the greatest proportion at lower levels of stepped care (ie, >100 self-guided apps and web sites). Virtual delivery of psychological strategies was common. Evidence gaps were noted at higher levels of stepped care (ie, requiring more resource and health professional involvement), integration with health records, communication with health professionals, web accessibility, and content addressing social/family support, medications, school, substance use, sleep, diet, and acute pain flares or crises. Evidence and Gap Maps are a novel visual knowledge synthesis tool, which enable rapid evidence-informed decision-making by patients and families, health professionals, and policymakers. This evidence and gap map identified high-quality virtual care solutions for immediate scale and spread and areas with no evidence in need of prioritization. Virtual care should address priorities identified by youth with chronic pain and their families.
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http://dx.doi.org/10.1097/j.pain.0000000000002339DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8516804PMC
November 2021

Rapid mobilization of a virtual pediatric chronic pain clinic in Canada during the COVID-19 pandemic.

Can J Pain 2020 Aug 5;4(1):162-167. Epub 2020 Aug 5.

Department of Anesthesia and Pain Medicine, Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada.

Background: Studies have been conducted describing the potential for using virtual care software during disasters and public health emergencies. However, limited data exist on ways in which the Canadian health care system utilizes virtual care during disasters or public health emergencies.

Aims: Due to the need for social distancing and reduction of nonessential ambulatory services during the COVID-19 pandemic, the SickKids Chronic Pain Clinic sought to transition care delivery from in person to virtual. The virtual clinic aimed to reduce risks associated with physical contact and environmental exposure without reducing access to care itself.

Methods: Harnessing of various digital tools including Ontario Telemedicine Network Guestlink, Zoom, and Microsoft Teams. The Chronic Pain Clinic Team worked together to communicate with patients and families, schedule virtual visits, establish remote access to clinical data collection tools, digitize the after-visit summary, and add resources on pain self-management to the clinic's website.

Results: The Chronic Pain Clinic successfully transitioned all clinic appointments (multidisciplinary and individual; 77 appointments) over a 2-week period to virtual care. Virtual clinics did not surpass the usual time taken pre-COVID-19, suggesting that the clinic workflow was readily adaptable to virtual care.

Conclusions: Access to quality virtual care is essential to prevent chronic pain from taking a toll on the lives of patients and families. Rapid establishment of a virtual clinic without gaps in service delivery to patients is possible given institutional support and a team culture centered around collaboration and flexibility.
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http://dx.doi.org/10.1080/24740527.2020.1771688DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7951167PMC
August 2020

Differential Risk Factor Profiles in the Prediction of General and Pain-Specific Functional Limitations 12 Months after Major Pediatric Surgery.

Children (Basel) 2021 Apr 30;8(5). Epub 2021 Apr 30.

Department of Psychology, York University, Toronto, ON M3J 1P3, Canada.

Pediatric chronic post-surgical pain is a surgical complication associated with various levels of functional limitation. Two commonly used measures of functional limitations in youth are the Functional Disability Inventory (FDI) and the PROMIS Pediatric Pain Interference Scale (PPIS), where the former is general, and the latter, pain specific. The aim of the present study was to prospectively compare pre-surgical youth and parent risk factors for youth functional limitations, assessed by the FDI and PPIS, 12 months after major pediatric surgery. Risk factors for the FDI and PPIS were compared in 79 dyads consisting of youth (58% female, = 14.56 years; SD = 2.31) undergoing major surgery and one of their parents. The FDI and PPIS were highly correlated prior to surgery ( = 0.698, < 0.001) and even more so 12 months after surgery ( = 0.807, < 0.001). Parent pre-surgical anxiety sensitivity and youth pre-surgical functional disability significantly predicted 12-month FDI ((6,56) = 4.443, = 0.001, Adjusted R = 0.25), whereas parent pre-surgical anxiety sensitivity, trait anxiety, pain anxiety, as well as youth pain-related anxiety and worry significantly predicted 12-month PPIS ((6,45) = 4.104, = 0.002, Adjusted R = 0.27). Risk factors for 12-month general and pain-specific functional limitations differ by dyad member and type. Functional limitations in youth after surgery are predicted by youth and parent factors, however the risk factors differ between the FDI and the PPIS.
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http://dx.doi.org/10.3390/children8050360DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8146066PMC
April 2021
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