e-Consent in UK academic-led clinical trials: current practice, challenges and the need for more evidence.

BACKGROUND: During the COVID-19 pandemic, in-person healthcare visits were reduced. Consequently, trial teams needed to consider implementing remote methods for conducting clinical trials, including e-Consent. Although some clinical trials may have implemented e-Consent prior to the pandemic, anecdotes of uptake for this method increased within academic-led trials. When the increased use of this process emerged, representatives from several large academic clinical trial groups within the UK collaborated to discuss ways in which trialists can learn from one another when implementing e-Consent. METHODS: A survey of UKCRC-registered Clinical Trials Units (CTUs) was undertaken in April-June 2021 to understand the implementation of and their views on the use of e-Consent and experiences from the perspectives of systems programmers and quality assurance staff on the use of e-Consent. CTUs not using e-Consent were asked to provide any reasons/barriers (including no suitable trials) and any plans for implementing it in the future. Two events for trialists and patient and public involvement (PPI) representatives were then held to disseminate findings, foster discussion, share experiences and aid in the identification of areas that the academic CTU community felt required more research. RESULTS: Thirty-four (64%) of 53 CTUs responded to the survey, with good geographical representation across the UK. Twenty-one (62%) of the responding CTUs had implemented e-Consent in at least one of their trials, across different types of trials, including CTIMPs (Clinical Trial of Investigational Medicinal Product), ATIMPs (Advanced Therapy Medicinal Products) and non-CTIMPs. One hundred ninety-seven participants attended the two workshops for wide-ranging discussions. CONCLUSION: e-Consent is increasingly used in academic-led trials, yet uncertainties remain amongst trialists, patients and members of the public. Uncertainties include a lack of formal, practical guidance and a lack of evidence to demonstrate optimal or appropriate methods to use. We strongly encourage trialists to continue to share their own experiences of the implementation of e-Consent.

Patient-reported outcomes for older adults on CamAPS FX closed loop system.

AIMS: Use of the CamAPS FX hybrid closed loop (CL) system is associated with improved time in range and glycated haemoglobin A1c across the age span, but little is known about its effects on patient-reported outcomes (PROs). METHODS: This open-label, randomized, multi-site study compared CamAPS FX to sensor-augmented pump (SAP) in a sample of older adults (≥60 years) with type 1 diabetes (T1D). Thirty-five older adults completed PROs surveys at the start of the study and after each period of 16 weeks using either CL or SAP. At the end of the study, 19 participated in interviews about their experiences with CL. RESULTS: Results examining the 16 weeks of CL use showed that the overall Diabetes Distress Scale score and two subscales (powerlessness and physician distress) improved significantly along with trust on the Glucose Monitoring Satisfaction Survey. User experience interview responses were consistent in noting benefits of 'improved glycaemic control' and 'worrying less about diabetes'. CONCLUSION: In this sample of older adults with T1D who have previously shown glycaemic benefit, there are indicators of improved PROs and subjective user experience benefits.

Incidence and sociodemographic, living environment and maternal health associations with stillbirth in a tertiary healthcare setting in Kano, Northern Nigeria.

BACKGROUND: Almost two million stillbirths occur annually, most occurring in low- and middle-income countries. Nigeria is reported to have one of the highest stillbirth rates on the African continent. The aim was to identify sociodemographic, living environment, and health status factors associated with stillbirth and determine the associations between pregnancy and birth factors and stillbirth in the Murtala Mohammed Specialist Hospital, Kano, Nigeria. METHODS: A three-month single-site prospective observational feasibility study. Demographic and clinical data were collected. We fitted bivariable and multivariable models for stillbirth (yes/no) and three-category livebirth/macerated stillbirth/non-macerated stillbirth outcomes to explore their association with demographic and clinical factors. FINDINGS: 1,998 neonates and 1,926 mothers were enrolled. Higher odds of stillbirth were associated with low-levels of maternal education, a further distance to travel to the hospital, living in a shack, maternal hypertension, previous stillbirth, birthing complications, increased duration of labour, antepartum haemorrhage, prolonged or obstructed labour, vaginal breech delivery, emergency caesarean-section, and signs of trauma to the neonate following birth. INTERPRETATION: This work has obtained data on some factors influencing stillbirth. This in turn will facilitate the development of improved public health interventions to reduce preventable deaths and to progress maternal health within this site.

Antibiotic resistance genes in the gut microbiota of mothers and linked neonates with or without sepsis from low- and middle-income countries.

Early development of the microbiome has been shown to affect general health and physical development of the infant and, although some studies have been undertaken in high-income countries, there are few studies from low- and middle-income countries. As part of the BARNARDS study, we examined the rectal microbiota of 2,931 neonates (term used up to 60 d) with clinical signs of sepsis and of 15,217 mothers screening for blaCTX-M-15, blaNDM, blaKPC and blaOXA-48-like genes, which were detected in 56.1%, 18.5%, 0% and 4.1% of neonates' rectal swabs and 47.1%, 4.6%, 0% and 1.6% of mothers' rectal swabs, respectively. Carbapenemase-positive bacteria were identified by MALDI-TOF MS and showed a high diversity of bacterial species (57 distinct species/genera) which exhibited resistance to most of the antibiotics tested. Escherichia coli, Klebsiella pneumoniae and Enterobacter cloacae/E. cloacae complex, the most commonly found isolates, were subjected to whole-genome sequencing analysis and revealed close relationships between isolates from different samples, suggesting transmission of bacteria between neonates, and between neonates and mothers. Associations between the carriage of antimicrobial resistance genes (ARGs) and healthcare/environmental factors were identified, and the presence of ARGs was a predictor of neonatal sepsis and adverse birth outcomes.

PrEP Use, Sexual Behaviour, and PrEP Adherence Among Men who have Sex with Men Living in Wales Prior to and During the COVID-19 Pandemic.

We examined PrEP use, condomless anal sex (CAS), and PrEP adherence among men who have sex with men (MSM) attending sexual health clinics in Wales, UK. In addition, we explored the association between the introduction of measures to control transmission of SARS-CoV-2 on these outcomes. We conducted an ecological momentary assessment study of individuals in receipt of PrEP in Wales. Participants used an electronic medication cap to record PrEP use and completed weekly sexual behaviour surveys. We defined adherence to daily PrEP as the percentage of CAS episodes covered by daily PrEP (preceded by ≥ 3 days of PrEP and followed by ≥ 2 days). Sixty participants were recruited between September 2019 and January 2020. PrEP use data prior to the introduction of control measures were available over 5785 person-days (88%) and following their introduction 7537 person-days (80%). Data on CAS episodes were available for 5559 (85%) and 7354 (78%) person-days prior to and following control measures respectively. Prior to the introduction of control measures, PrEP was taken on 3791/5785 (66%) days, there were CAS episodes on 506/5559 (9%) days, and 207/406 (51%) of CAS episodes were covered by an adequate amount of daily PrEP. The introduction of pandemic-related control measures was associated with a reduction in PrEP use (OR 0.44, 95%CI 0.20-0.95), CAS (OR 0.35, 95%CI 0.17-0.69), and PrEP adherence (RR = 0.55, 95%CI 0.34-0.89) and this may have implications for the health and wellbeing of PrEP users and, in addition to disruption across sexual health services, may contribute to wider threats across the HIV prevention cascade.

A qualitative focus group study concerning perceptions and experiences of Nigerian mothers on stillbirths.

OBJECTIVE: To explore the experiences and perceptions of stillbirth among mothers from a tertiary medical centre in Kano, Northern Nigeria. DESIGN: Qualitative, interpretative. SETTING: Tertiary healthcare facility, Murtala Muhammad Specialist Hospital (MMSH), Kano, Northern Nigeria. SAMPLE: Mothers who had given birth to a liveborn baby at the MMSH in the prior 6 months (n = 31). In order to capture the experiences and perception of stillbirth within this cohort we approached mothers who had in a previous pregnancy experienced a stillbirth. Of the 31 who attended 16 had a previous stillbirth. METHODS: Semi-structured Focus Group Discussions, consisting of open-ended questions about stillbirth, beliefs, experiences and influences were held in MMSH, conducted over 1 day. RESULTS: Our findings highlight that this is a resource-poor tertiary facility serving an ever-growing population, increasing strain on the hospital and healthcare workers. Many of the participants highlighted needing permission from certain family members before accessing healthcare or medical treatment. We identified that mothers generally have knowledge on self-care during pregnancy, yet certain societal factors prevented that from being their priority. Judgement and blame was a common theme, yet a complex area entwined with traditions, superstitions and the pressure to procreate with many mothers described being made to feel useless and worthless if they did not birth a live baby. CONCLUSIONS: As access to healthcare becomes easier, there are certain traditions, family and social dynamics and beliefs which conflict with scientific knowledge and act as a major barrier to uptake of healthcare services. The findings highlight the need for investment in maternity care, appropriate health education and public enlightenment; they will help inform appropriate interventions aimed at reducing stigma around stillbirth and aide in educating mothers about the importance of appropriate health seeking behaviour. Stillbirths are occurring in this area of the world unnecessarily, globally there has been extensive research conducted on stillbirth prevention. This research has highlighted some of the areas which can be tackled by modifying existing successful interventions to work towards reducing preventable stillbirths.

Development of a core outcome set for the evaluation of interventions to enhance trial participation decisions on behalf of adults who lack capacity to consent: a mixed methods study (COnSiDER Study).

BACKGROUND: Trials involving adults who lack capacity to provide consent rely on proxy or surrogate decision-makers, usually a family member, to make decisions about participation. Interventions to enhance proxy decisions about trial participation are now being developed. However, a lack of standardised outcome measures limits evaluation of these interventions. The aim of this study was to establish an agreed standardised core outcome set (COS) for use when evaluating interventions to improve proxy decisions about trial participation. METHODS: We used established methods to develop the COS including a consensus study with key stakeholder groups comprising those who will use the COS in research (researchers and healthcare professionals) and patients or their representatives. Following a scoping review to identify candidate items, we used a modified two-round Delphi survey to achieve consensus on core outcomes, with equivocal items taken to a consensus meeting for discussion. The COS was finalised following an online consensus meeting in October 2020. RESULTS: A total of 28 UK stakeholders (5 researchers, 10 trialists, 3 patient/family representatives, 7 recruiters and 3 advisors/approvers) participated in the online Delphi survey to rank candidate items from the scoping review (n = 36) and additional items proposed by participants (n = 1). Items were broadly grouped into three categories: how family members make decisions, their experiences of making decisions, and the personal aspects that influence the decision. Following the Delphi survey, 27 items were included and ten items exhibited no consensus which required discussion at the consensus meeting. Sixteen participants attended the meeting, including additional patient/family representatives invited to increase representation from this key group (n = 2). We reached consensus for the inclusion of 28 outcome items, including one selected at the consensus meeting. CONCLUSIONS: The study identified outcomes that should be measured as a minimum in all evaluations of interventions to enhance proxy decisions about trials. These relate to the process of decision-making, proxies' experience of decision-making, and factors that influence decision-making such as understanding. Further work with people with impairing conditions and their families is needed to explore their views about the COS and to identify appropriate outcome measures and timing of measurement. TRIAL REGISTRATION: The study is registered on the COMET database ( https://www.comet-initiative.org/Studies/Details/1409 ).

The Use of Posturography in Investigating the Risk of Falling in Frail or Prefrail Older People with Diabetes.

BACKGROUND: In older people, diabetes is associated with an increased risk of falls and frailty. The value of using posturography for evaluating the risk of falling is unclear. In theory, a time-scale analysis should increase the metrological properties of the posturography assessment. OBJECTIVES: This study aimed to determine which posturographic parameters can be used to identify fall-risk patients in a frail diabetic older population and to assess their interest in comparison to usual clinical trials for gait and balance. DESIGN: This is a prospective observational cohort. SETTINGS: frail or pre-frail diabetic patients, in Bordeaux, France. PARTICIPANTS: 84 patients were included in the study (mean age 80.09 years, 64.5% of men).Criteria for inclusion were: age over 70 years, diabetes mellitus for over 2 years, and at least one of the Fried's frailty criteria. MEASUREMENTS: Gait and balance assessments were undertaken at baseline: Static posturography, the timed up and go test, short physical performance battery, and (gait) walking speed. Raw data from posturography were used for wavelet analysis. Data on self reported new falls were collected prospectively during 6 months. RESULTS: The posturography parameter most useful was area of 90% confidence ellipse of statokinesigram (COP90area): area under the ROC curve AUC = 0.617 (95% CI, 0.445-0.789) and OR=1.003 (95%CI 1.000-1.005) p =0.05. The optimum clinical test was the time to walk over 4m AUC=0.735 (95%CI, 0.587-0.882) and OR=1.42 (95%CI 1.08-1.87) p= 0.013. CONCLUSION: Posturography has limited utility for assessment of falls risk in frail older people with diabetes. Gait and balance clinical assessments such as walking speed continue to retain their value.

Monetary reinforcement for self-monitoring of blood glucose among young people with type 1 diabetes: evaluating effects on psychosocial functioning.

AIMS: To explore the auxiliary psychosocial effects of a monetary reinforcement intervention targeting self-monitoring of blood glucose among young people with Type 1 diabetes. METHODS: Sixty young people with Type 1 diabetes, HbA1c concentrations between 58 and 119 mmol/mol (7.5-13.0%), and average self-monitoring of blood glucose <4 times per day were randomized to either enhanced usual care or a 24-week intervention of monetary rewards for self-monitoring of blood glucose and associated behaviours (e.g. uploading glucose meters). Data were collected from the young people and their parents at baseline, during the intervention (6, 12 and 24 weeks) and after the intervention (36 weeks). RESULTS: Linear mixed models were used to evaluate the intervention effects on psychosocial outcomes, adjusting for corresponding baseline levels and potential moderation by baseline level. The intervention reduced diabetes distress at week 6 among young people who had average and high baseline distress. It also reduced diabetes distress at weeks 12 and 24 among those with low baseline distress. The intervention also reduced young person-reported diabetes-related family conflict and diabetes-related interference among those with high baseline scores in these areas; however, the intervention worsened young person-reported diabetes interference among those with low baseline interference. Effects were medium-sized and time-limited. CONCLUSIONS: Findings indicate predominantly positive impacts of monetary reinforcement interventions on psychosocial outcomes, although effects varied by outcome and time point. Whereas early improvements in diabetes distress were observed for all who received the intervention, improvements in other areas varied according to the level of psychosocial challenge at baseline. Incorporating psychosocial interventions may bolster and maintain effects over time.

What the public think about participation in medical research during an influenza pandemic: an international cross-sectional survey.

OBJECTIVES: The public and patients are primary contributors and beneficiaries of pandemic-relevant clinical research. However, their views on research participation during a pandemic have not been systematically studied. We aimed to understand public views regarding participation in clinical research during a hypothetical influenza pandemic. STUDY DESIGN: This is an international cross-sectional survey. METHODS: We surveyed the views of nationally representative samples of people in Belgium, Poland, Spain, Ireland, the United Kingdom, Canada, Australia and New Zealand, using a scenario-based instrument during the 2017 regional influenza season. Descriptive and regression analyses were conducted. RESULTS: Of the 6804 respondents, 5572 (81.8%) thought pandemic-relevant research was important, and 5089 (74.8%) thought 'special rules' should be applied to make this research feasible. The respondents indicated willingness to take part in lower risk (4715, 69.3%) and higher risk (3585, 52.7%) primary care and lower risk (4780, 70.3%) and higher risk (4113, 60.4%) intensive care unit (ICU) study scenarios. For primary care studies, most (3972, 58.4%) participants preferred standard enrolment procedures such as prospective written informed consent, but 2327 (34.2%) thought simplified procedures would be acceptable. For ICU studies, 2800 (41.2%) preferred deferred consent, and 2623 (38.6%) preferred prospective third-party consent. Greater knowledge about pandemics, trust in a health professional, trust in the government, therapeutic misconception and having had ICU experience as a patient or carer predicted increased willingness to participate in pandemic-relevant research. CONCLUSIONS: Our study indicates current public support for pandemic-relevant clinical research. Tailored information and initiatives to advance research literacy and maintain trust are required to support pandemic-relevant research participation and engagement.

Frailty and Brain-Muscle Correlates in Older People With Type 2 Diabetes: A structural-MRI Explorative Study.

OBJECTIVES: Muscle alterations, mainly functional alterations are frequently observed in older people with type 2 diabetes (T2DM). Sarcopenia may be one mechanism of transition to frailty in these people. Thus, we aim to explore the characteristics of muscle and its association with cerebral grey matter volumes within this group. METHODS: Single center study nested within the international MID-Frail (a randomized clinical trial to evaluate the effectiveness of a multi-modal intervention in older people with T2DM on frailty and quality of life) trial participants underwent both brain and muscle T1 MRI, nutritional and functional assessments. Muscle areas were measured in rectus femoris (RF). Relationships between MRI grey matter volumes and muscle areas or function tests were described using positive and negative regressions. RESULTS: Twenty-six subjects (7 female, mean age 78.2 y, SD 5.0), 6 frail and 20 pre-frail were explored in this sub-study. Frail subjects had lower Mini Nutritional Assessment (MNA), Short Physical Performance Battery (SPPB), hip flexor strength than pre-frail ones but similar BMI and balance. Total SPPB was positively related with hip flexor strength and maximal RF area. Balance SPPB sub-score was unrelated to strength or RF area. MNA score was correlated with hip flexor strength and to global grey matter but not to SPPB. Hip flexor strength was correlated with grey matter areas involved in motor control. Walking time was negatively and rising chair sub-score was positively associated with grey matter volumes of motor areas. CONCLUSIONS: Sarcopenia features were more frequent in frail than prefrail subjects and were associated with decrease in grey matter volumes involved in motor control.

Exposure to Adverse Childhood Experiences and Oral Health Measures in Adulthood: Findings from the 2010 Behavioral Risk Factor Surveillance System.

INTRODUCTION: Adverse childhood experiences (ACEs) are negative life events occurring before the age of 18 y. ACEs are risk factors for heart disease and diabetes in adult life. Furthermore, individuals who experience ACEs are more likely to smoke and become obese-factors associated with poor oral health. OBJECTIVE: This study investigated likely associations between ACEs and the oral health measures of the 2010 Behavioral Risk Factor Surveillance System (BRFSS). METHODS: Data from 16,354 participants of the 2010 BRFSS were analyzed with SAS 9.4. ACE scores were calculated in 2 domains: abuse (emotional, physical, or sexual) and household challenges (parental separation or divorce, intimate partner violence, household substance abuse, household mental illness, and incarceration). ACE scores, ranging from 0 to 8, were categorized into 0, 1, 2, 3, and ≥4. The 2010 BRFSS oral health measures included >1 y since last dental visit, ≥6 teeth extracted, and ≥2 y since last dental cleaning. Survey logistic regression estimated prevalence odds ratios and 95% CIs, adjusted for age, sex, race/ethnicity, and educational attainment. RESULTS: The weighted mean ACE score was 1.74 (95% CI = 1.68 to 1.81), and the weighted and age-standardized percentages of study participants with ACE scores of 0, 1, 2, 3, and ≥4 were 33.1%, 24.3%, 14.9%, 9.69%, and 18.1%, respectively. There appeared to be a dose-response association between categories of ACE scores and the oral health measures. Specifically, when compared with participants with an ACE score of 0, participants with ACE scores of 1, 2, 3, and ≥4 had adjusted prevalence odds ratios (95% CIs) of 1.10 (0.82 to 1.47), 1.20 (0.90 to 1.60), 1.35 (0.98 to 1.85), and 1.72 (1.31 to 2.26), respectively, for reporting ≥2 y since last dental cleaning. CONCLUSIONS: Findings suggest that ACEs may be associated with poor oral health measures in adulthood, even after adjusting for important oral diseases risk factors. Longitudinal follow-up studies are needed to delineate pathways by which this relationship occurs. KNOWLEDGE TRANSFER STATEMENT: Our findings indicate that exposure to childhood trauma may have negative impacts on oral health in adulthood. Oral health practitioners need to be aware of the potential impacts of childhood trauma on health behaviors that ultimately affect oral health outcomes.

Assessing patient-reported outcomes for automated insulin delivery systems: the psychometric properties of the INSPIRE measures.

AIM: Participants in clinical trials assessing automated insulin delivery systems report perceived benefits and burdens that reflect their experiences and may predict their likelihood of uptake and continued use of this novel technology. Despite the importance of understanding their perspectives, there are no available validated and reliable measures assessing the psychosocial aspects of automated insulin delivery systems. The present study assesses the initial psychometric properties of the INSPIRE measures, which were developed for youth and adults with Type 1 diabetes, as well as parents and partners. METHODS: Data from 292 youth, 159 adults, 150 parents of youth and 149 partners of individuals recruited from the Type 1 Diabetes Exchange Registry were analysed. Participants completed INSPIRE questionnaires and measures of quality of life, fear of hypoglycaemia, diabetes distress, glucose monitoring satisfaction. Exploratory factor analysis assessed factor structures. Associations between INSPIRE scores and other measures, HbA1c , and technology use assessed concurrent and discriminant validity. RESULTS: Youth, adult, parent and partner measures assess positive expectancies of automated insulin delivery systems. Measures range from 17 to 22 items and are reliable (α = 0.95-0.97). Youth, adult and parent measures are unidimensional; the partner measure has a two-factor structure (perceptions of impact on partners versus the person with diabetes). Measures showed concurrent and discriminant validity. CONCLUSIONS: INSPIRE measures assessing the positive expectancies of automated insulin delivery systems for youth, adults, parents and partners have meaningful factor structures and are internally consistent. The developmentally sensitive INSPIRE measures offer added value as clinical trials test newer systems, systems become commercially available and clinicians initiate using these systems.

The acceptability of fluoride varnish and fissure sealant treatments in children aged 6-9 delivered in a school setting.

OBJECTIVE: To assess the acceptability of fluoride varnish and fissure sealant treatments for children. To investigate the acceptability of delivering this treatment in a school setting for children, parents, clinicians and school staff. BASIC RESEARCH DESIGN: Semi-structured interviews (with children, parents, clinicians and school staff) and a questionnaire (for school staff) as part of a two-arm, randomised clinical trial. PARTICIPANTS: Children aged 6-9, their parents, clinical staff and school staff. INTERVENTIONS: Fluoride varnish or fissure sealant was delivered to children from the ages of 6 to 9 years for 36 months, by a community dental service in a school setting. Fluoride varnish was re-applied every 6 months; fissure sealant was applied once to first permanent molars and re-applied as required. RESULTS: Interviews with children a few days after treatment indicated little difference in preference; acceptability at this point was driven by factors such as finding it fun to visit 'the van' (i.e. mobile dental unit) and receiving a "sticker" rather than specific treatment received. Interviews with parents, clinicians and school staff indicated high acceptability of delivering this type of intervention in a school setting; this may have been partly due to the service being delivered by a well-established, child-oriented community dental service which delivered the clinical trial. CONCLUSIONS: Preventive fluoride varnish and fissure sealant treatments in a school setting has high overall acceptability.

Pediatric Quality of Life Inventory (PedsQL) 3.2 Diabetes Module for youth with Type 2 diabetes: reliability and validity.

AIM: To test the measurement properties of the revised and updated Pediatric Quality of Life Inventory (PedsQL) 3.2 Diabetes Module originally developed in Type 1 diabetes in youth with Type 2 diabetes. METHODS: The PedsQL 3.2 Diabetes Module and PedsQL Generic Core Scales were administered in a field test study to 100 young people aged 9-25 years with Type 2 diabetes. Factor analysis was conducted to determine the factor structure of the items. RESULTS: The 15-item Diabetes Symptoms Summary Score and 12-item Type 2-specific Diabetes Management Summary Score were empirically derived through factor analysis. The Diabetes Symptoms and Type 2-specific Diabetes Management Summary Scores showed acceptable to excellent reliability across the age groups tested (α = 0.85-0.94). The Diabetes Symptoms and Type 2-specific Diabetes Management Summary Scores evidenced construct validity through large effect size correlations with the Generic Core Scales Total Scale Score (r = 0.67 and 0.57, respectively). HbA1c was correlated with the Diabetes Symptoms and Type 2-specific Diabetes Management Summary Scores (r = -0.13 and -0.22). Minimal clinically important difference (MCID) scores were 5.91 and 7.39 for the Diabetes Symptoms and Type 2-specific Diabetes Management Summary Scores. CONCLUSIONS: The PedsQL 3.2 Diabetes Module Diabetes Symptoms Summary Score and Type 2-specific Diabetes Management Summary Score exhibited satisfactory measurement properties for use as youth self-reported diabetes symptoms and diabetes management outcomes for clinical research and clinical practice for young people with Type 2 diabetes.

Diabetes technology: improving care, improving patient-reported outcomes and preventing complications in young people with Type 1 diabetes.

With the evolution of diabetes technology, those living with Type 1 diabetes are given a wider arsenal of tools with which to achieve glycaemic control and improve patient-reported outcomes. Furthermore, the use of these technologies may help reduce the risk of acute complications, such as severe hypoglycaemia and diabetic ketoacidosis, as well as long-term macro- and microvascular complications. In addition, diabetes technology can have a beneficial impact on psychosocial health by reducing the burden of diabetes. Unfortunately, diabetes goals are often unmet and people with Type 1 diabetes too frequently experience acute and long-term complications of this condition, in addition to often having less than ideal psychosocial outcomes. Increasing realization of the importance of patient-reported outcomes is leading to diabetes care delivery becoming more patient-centred. Diabetes technology in the form of medical devices, digital health and big data analytics have the potential to improve clinical care and psychosocial support, resulting in lower rates of acute and chronic complications, decreased burden of diabetes care, and improved quality of life.

Adapting and validating a measure of diabetes-specific self-compassion.

AIMS: Self-compassion (SC), or treating oneself with kindness when dealing with personal challenges, has not been rigorously examined in people with T1D. SC has been shown to buffer against negative emotions and to be linked to improved health outcomes, but diabetes-specific SC has not been studied. This study aimed to adapt the Self-Compassion Scale and validate it for a diabetes-specific population. METHODS: We developed and validated a diabetes-specific version of the Self-Compassion Scale (Neff, 2003) in a sample of adults with T1D (N=542; 65% female; 97% non-Hispanic White; M age 41, SD=15.7; M A1c=7.3, SD=1; 72% insulin pump users; 50% continuous glucose monitoring [CGM] users). Confirmatory factor analyses (CFA), and reliability and construct validity analyses were conducted. Validity measures included diabetes distress, diabetes empowerment, diabetes numeracy, and A1c. RESULTS: A two-factor bi-factor structure showed best fit, providing support for use of the adapted scale (SCS-D) as a unitary construct. The 19-item unidimensional SCS-D demonstrated excellent internal consistency (ɑ=0.94; range of item-total correlations: 0.52-0.71) and construct validity. As hypothesized, higher SCS-D was associated with less distress, greater empowerment, and lower A1c, and was not associated with numeracy. CONCLUSIONS: The SCS-D is a reliable and valid measure of diabetes-specific self-compassion in adults with T1D.

Levels of wound calprotectin and other inflammatory biomarkers aid in deciding which patients with a diabetic foot ulcer need antibiotic therapy (INDUCE study).

AIMS: Deciding if a diabetic foot ulcer is infected in a community setting is challenging without validated point-of-care tests. Four inflammatory biomarkers were investigated to develop a composite algorithm for mildly infected diabetic foot ulcers: venous white cell count, C-reactive protein (CRP) and procalcitonin, and a novel wound exudate calprotectin assay. Calprotectin is a marker of neutrophilic inflammation. METHODS: In a prospective study, people with uninfected or mildly infected diabetic foot ulcers who had not received oral antibiotics in the preceding 2 weeks were recruited from community podiatry clinics for measurement of inflammatory biomarkers. Antibiotic prescribing decisions were based on clinicians' baseline assessments and participants were reviewed 1 week later; ulcer infection was defined by clinicians' overall impression from their two assessments. RESULTS: Some 363 potential participants were screened, of whom 67 were recruited, 29 with mildly infected diabetic foot ulcers and 38 with no infection. One participant withdrew early in each group. Ulcer area was 1.32 cm2 [interquartile range (IQR) 0.32-3.61 cm2 ] in infected ulcers and 0.22 cm2 (IQR 0.09-1.46 cm2 ) in uninfected ulcers. Baseline CRP for mild infection was 9.00 mg/ml and 6.00 mg/ml for uninfected ulcers; most procalcitonin levels were undetectable. Median calprotectin level in infected diabetic foot ulcers was 1437 ng/ml and 879 ng/ml in uninfected diabetic foot ulcers. Area under the receiver operating characteristic curve for a composite algorithm incorporating calprotectin, CRP, white cell count and ulcer area was 0.68 (95% confidence intervals 0.52-0.82), sensitivity 0.64, specificity 0.81. CONCLUSIONS: A composite algorithm including CRP, calprotectin, white cell count and ulcer area may help to distinguish uninfected from mildly infected diabetic foot ulcers. Venous procalcitonin is unhelpful for mild diabetic foot ulcer infection.

Viscoelastometric-guided early fibrinogen concentrate replacement during postpartum haemorrhage: OBS2, a double-blind randomized controlled trial.

BACKGROUND: Postpartum haemorrhage (PPH) can be exacerbated by haemostatic failure. We hypothesized that early fibrinogen replacement, guided by viscoelastometric testing, reduces blood product usage and bleed size. METHODS: Women with PPH 1000-1500 ml were enrolled. If Fibtem A5 was ≤15 mm and bleeding continued, subjects were randomized to fibrinogen concentrate or placebo. The primary outcome compared the number of units of red blood cells, plasma, cryoprecipitate and platelets transfused. RESULTS: Of 663 women enrolled 55 were randomized. The adjusted incidence rate ratio (IRR) (95% CI) for the number of allogeneic units transfused in the fibrinogen group compared with placebo was 0.72 (0.3-1.7), P =0.45. In pre-specified subgroup analyses, subjects who had a Fibtem A5 ≤12 mm at the time of randomization and who received fibrinogen concentrate received a median (25th-75th centile) of 1 (0-4.5) unit of allogeneic blood products and had an additional 300 (100-350) ml blood loss whereas those who received placebo also received 3 (0-6) units of allogeneic blood products and had 700 (200-1550) ml additional blood loss; these differences were not statistically significantly different. There was one thrombotic event in each group. CONCLUSIONS: Infusion of fibrinogen concentrate triggered by Fibtem A5 ≤15 mm did not improve outcomes in PPH. Pre-specified subgroup analyses suggest that fibrinogen replacement is not required if the Fibtem A5 is > 12 mm or Clauss fibrinogen >2 g litre -1 , but an effect below these levels cannot be excluded. The raised fibrinogen at term appears to be a physiological buffer rather than required for haemostasis. TRIAL REGISTRATION: ISRCTN46295339 ( http://www.isrctn.com/ISRCTN46295339 , last accessed 5 July 2017), EudraCT 2012-005511-11 ( https://www.clinicaltrialsregister.eu/ctr-search/search?query=2012-005511-11 , last accessed 5 July 2017).

Viscoelastometry guided fresh frozen plasma infusion for postpartum haemorrhage: OBS2, an observational study.

BACKGROUND: Postpartum haemorrhage (PPH) can be exacerbated by haemostatic failure. Based on data from trauma studies, empirical infusions of fresh frozen plasma (FFP) are often given during severe PPH if coagulation tests are unavailable. This study observed a cohort of women with moderate/severe PPH in whom FFP infusion was guided by the use of viscoelastometric point-of-care testing (VE-POCT) and clinical assessment. METHODS: Women were enrolled into this observational study when blood loss was measured or suspected to be about 1000 mL. If Fibtem A5 determined by Rotem ® thromboelastometry remained >15 mm, or bleeding stopped, FFP was withheld. If Fibtem A5 was ≤15 mm and bleeding ongoing, women were randomized into an interventional study as previously reported. Clinical and laboratory outcomes were recorded. RESULTS: The study recruited 605 women and 98% had FFP withheld. The median (25 th -75 th centile) total blood loss was 1500 (1300-2000) mL with 300 (50-545) mL occurring after enrolment. Total blood loss was >2500 mL in 40/605 (6.6%) women. RBCs were transfused in 141/605 (23.3%) patients and 11 (1.8%) received ≥4 units. At least one invasive procedure was performed in 283/605 (46.8%) women. Level 3 care was required for 10/605 (1.7%) women. No women developed clinically significant haemostatic impairment. CONCLUSIONS: Restrictive use of FFP guided by clinical assessment of bleeding and VE-POCT is feasible and did not result in clinically significant haemostatic impairment. Studies should compare the clinical and cost effectiveness of empirical FFP infusions, according to current guidelines, with targeted use of FFP based on VE-POCT. CLINICAL TRIAL REGISTRATION: ISRCTN46295339 ( http://www.isrctn.com/ISRCTN46295339 ) (accessed July 24, 2017), EudraCT 2012-005511-11 ( https://www.clinicaltrialsregister.eu/ctr-search?query=2011-005511-11 ) (accessed July 24, 2017).