Who Should Access Closed-Loop Technology? A Qualitative Study of Clinician Attitudes in England.

Background: Clinicians mediate access to closed-loop technology for people with diabetes. Consequently, their attitudes regarding appropriate levels of closed-loop usage will play a key role in future adoption processes. This study aimed to explore clinician attitudes toward future mainstream closed-loop usage in England. Materials and Methods: We conducted 36 semistructured interviews with clinicians from a range of professional backgrounds working in outpatient clinics in England. Interview topics included clinicians' views on future pathways for closed-loop use and attitudes toward the predictability of users' technology experiences, a key factor in eligibility decision making. We analyzed transcripts using thematic and framework approaches. Results: Clinicians exhibited a range of opinions regarding future eligibility for closed-loop technology. We identified three key strands of clinician opinion, envisaging (1) tighter access for closed loop (n = 10), citing funding challenges and issues arising from user overconfidence or negative technology attitudes; (2) similar access to closed loop as for current diabetes technologies (n = 15), on the grounds that future funding and access pathways will be similar to current arrangements; and (3) wider access for closed-loop technologies (n = 9), given the potential for significant and widespread benefits arising from closed-loop usage, including downstream cost savings alongside improved glycemic control. Conclusions: Clinicians expressed a range of opinions encompassing continuity with current diabetes technologies, while others envisaged either tighter or more liberal access for closed-loop systems. To optimize technology adoption and equitable uptake, future implementation pathways should consider clinician attitudes toward technology use and access.

Ambassadors of hope, research pioneers and agents of change-individuals' expectations and experiences of taking part in a randomised trial of an innovative health technology: longitudinal qualitative study.

BACKGROUND: While a growing body of research has explored why people take part in clinical trials, this research has not considered how people's understandings, motivations and agendas might influence their conduct during a trial. This is an important area of enquiry because it is now widely recognised that an intervention might lead to different clinical outcomes when delivered as part of a trial than when implemented in routine clinical practice; however, the reasons for this are not fully understood. METHODS/DESIGN: We interviewed 24 individuals who took part in a trial of an innovative health technology under development for people with type 1 diabetes which automatically regulates blood glucose: the closed-loop system. Participants were interviewed following randomisation to a closed-loop and at trial closeout. RESULTS: Participants provided complex agendas for taking part in which altruistic and self-interested considerations were often inseparable. Many described belonging to a wider diabetes community and being beneficiaries of others' participation in research and how this had given rise to attendant citizenship obligations. Participants also shared the excitement and pride they experienced from contributing to research which situated them at the forefront of technological innovation and enabled them to present themselves to others, by virtue of their trial participation, as ambassadors of hope and research pioneers. Given their desire to support the progression of a potentially life-changing technology, and be part of that innovation, participants, at follow-up, described having made extra effort during the trial. Specifically, participants described having been more focused on their diabetes management to help create conditions in which the closed-loop could work most effectively to optimize their blood glucose control. CONCLUSIONS: Our findings contribute a new dimension to understandings of trial effects; specifically, we argue that, to aid interpretation of trial outcomes, participants' understandings and motivations for participation need to be considered. We highlight the potential pertinence of our findings in the contemporary era of bio-citizenship where, increasingly, people are driving research agendas and see themselves as co-producers of knowledge. We also recommend a new concept be introduced into the literature-'the altruselfish agenda'-to recognise potential inseparability of self-interested and altruistic motivations. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02523131 . Registered on 14 August 2015.

Women's Experiences of Day-and-Night Closed-Loop Insulin Delivery During Type 1 Diabetes Pregnancy.

AIMS: Closed-loop insulin delivery has the potential to improve day-to-day glucose control in type 1 diabetes pregnancy. However, the psychosocial impact of day-and-night usage of automated closed-loop systems during pregnancy is unknown. Our aim was to explore women's experiences and relationships between technology experience and levels of trust in closed-loop therapy. METHODS: We recruited 16 pregnant women with type 1 diabetes to a randomized crossover trial of sensor-augmented pump therapy compared to automated closed-loop therapy. We conducted semistructured qualitative interviews at baseline and follow-up. Findings from follow-up interviews are reported here. RESULTS: Women described benefits and burdens of closed-loop systems during pregnancy. Feelings of improved glucose control, excitement and peace of mind were counterbalanced by concerns about technical glitches, CGM inaccuracy, and the burden of maintenance requirements. Women expressed varied but mostly high levels of trust in closed-loop therapy. CONCLUSIONS: Women displayed complex psychosocial responses to day-and-night closed-loop therapy in pregnancy. Clinicians should consider closed-loop therapy not just in terms of its potential impact on biomedical outcomes but also in terms of its impact on users' lives.

Adaptability of Closed Loop During Labor, Delivery, and Postpartum: A Secondary Analysis of Data from Two Randomized Crossover Trials in Type 1 Diabetes Pregnancy.

Tight glucose control during labor and delivery is recommended for pregnant women with type 1 diabetes. This can be challenging to achieve using the current treatment modalities. The automated nature of closed loop and its ability to adapt to real-time glucose levels make it well suited for use during labor, delivery, and the immediate postpartum period. We report observational data of participants from two randomized crossover trials who chose to continue using closed loop during labor, delivery, and postpartum. Labor was defined as the 24 h before delivery and postpartum as the 48 h after delivery. The glucose target range during pregnancy was 3.5-7.8 mmol/L (63-140 mg/dL) and 3.9-10 mmol/L (70-180 mg/dL) after delivery. Twenty-seven (84.4%) of the potential 32 trial participants used closed loop through labor, delivery, and postpartum. Use of closed loop was associated with 82.0% (interquartile range [IQR] 49.3, 93.0) time-in-target range during labor and delivery and a mean glucose of 6.9 ± 1.4 mmol/L (124 ± 25 mg/dL). Closed loop performed well throughout vaginal, elective, and emergency cesarean section deliveries. Postpartum, women spent 83.3% (IQR 75.2, 94.6) time-in-target range (3.9-10.0 mmol/L [70-180 mg/dL]), with a mean glucose of 7.2 ± 1.4 mmol/L (130 ± 25 mg/dL). There was no difference in maternal glucose concentration between mothers of infants with and without neonatal hypoglycemia (6.9 ± 1.6 mmol/L and 6.8 ± 1.1 mmol/L [124 ± 29 mg/dL and 122 ± 20 mg/dL] respectively; P = 0.84). Automated closed-loop insulin delivery is feasible during hospital admissions for labor, delivery, and postpartum. Larger scale studies are needed to evaluate its efficacy compared with current clinical approaches as well as understand how women and healthcare providers will adopt this technology.

Day-and-Night Closed-Loop Insulin Delivery in a Broad Population of Pregnant Women With Type 1 Diabetes: A Randomized Controlled Crossover Trial.

OBJECTIVE: Despite advances in technology, optimal glucose control remains elusive and neonatal complications remain ubiquitous in type 1 diabetes (T1D) pregnancy. Our aim was to examine the safety, efficacy, and longer-term feasibility of day-and-night closed-loop insulin delivery. RESEARCH DESIGN AND METHODS: We recruited 16 pregnant women (mean [SD]: age 32.8 [5.0] years, T1D duration 19.4 [10.2] years, HbA1c 8.0% [1.1], and BMI 26.6 [4.4] kg/m2) to an open-label, randomized, crossover trial. Participants completed 28 days of closed-loop and sensor-augmented pump (SAP) insulin delivery separated by a washout period. Afterward, participants could continue to use the closed-loop system up to 6 weeks postpartum. The primary end point was the proportion of time with glucose levels within the target range (63-140 mg/dL). RESULTS: The proportion of time with glucose levels within target was comparable during closed-loop and SAP insulin delivery (62.3 vs. 60.1% [95% CI -4.1 to 8.3]; P = 0.47). Mean glucose and time spent hyperglycemic >140 mg/dL also did not differ (131.4 vs. 131.4 mg/dL [P = 0.85] and 36.6 vs. 36.1% [P = 0.86], respectively). During closed-loop, fewer hypoglycemic episodes occurred (median 8 [range 1-17] vs. 12.5 [1-53] over 28 days; P = 0.04) and less time at <63 mg/dL (1.6 vs. 2.7%; P = 0.02). Hypoglycemia <50 mg/dL (0.24 vs. 0.47%; P = 0.03) and low blood glucose index (1.0 vs. 1.4; P = 0.01) were lower. Less nocturnal hypoglycemia (2300-0700 h) during closed-loop therapy (1.1 vs. 2.7%; P = 0.008) and a trend toward higher overnight time in target (67.7 vs. 60.6%; P = 0.06) were found. CONCLUSIONS: Closed-loop insulin delivery was associated with comparable glucose control and significantly less hypoglycemia than SAP therapy. Larger, longer-duration multicenter trials are now indicated to determine clinical efficacy of closed-loop insulin delivery in T1D pregnancy and the impact on neonatal outcomes.

Doctors' engagements with patient experience surveys in primary and secondary care: a qualitative study.

BACKGROUND: Patient experience surveys are increasingly important in the measurement of, and attempts to improve, health-care quality. To date, little research has focused upon doctors' attitudes to surveys which give them personalized feedback. AIM: This paper explores doctors' perceptions of patient experience surveys in primary and secondary care settings in order to deepen understandings of how doctors view the plausibility of such surveys. DESIGN, SETTING AND PARTICIPANTS: We conducted a qualitative study with doctors in two regions of England, involving in-depth semi-structured interviews with doctors working in primary care (n = 21) and secondary care (n = 20) settings. The doctors in both settings had recently received individualized feedback from patient experience surveys. FINDINGS: Doctors in both settings express strong personal commitments to incorporating patient feedback in quality improvement efforts. However, they also concurrently express strong negative views about the credibility of survey findings and patients' motivations and competence in providing feedback. Thus, individual doctors demonstrate contradictory views regarding the plausibility of patient surveys, leading to complex, varied and on balance negative engagements with patient feedback. DISCUSSION: Doctors' contradictory views towards patient experience surveys are likely to limit the impact of such surveys in quality improvement initiatives in primary and secondary care. We highlight the need for 'sensegiving' initiatives (i.e. attempts to influence perceptions by communicating particular ideas, narratives and visions) to engage with doctors regarding the plausibility of patient experience surveys. CONCLUSION: This study highlights the importance of engaging with doctors' views about patient experience surveys when developing quality improvement initiatives.

Factors Affecting Recruitment of Participants for Studies of Diabetes Technology in Newly Diagnosed Youth with Type 1 Diabetes: A Qualitative Focus Group Study with Parents and Children.

BACKGROUND: Relatively little is known about parents' or children's attitudes toward recruitment for, and participation in, studies of new diabetes technologies immediately after diagnosis. This study investigated factors affecting recruitment of participants for studies in newly diagnosed youth with type 1 diabetes. METHODS: Qualitative focus group study incorporating four recorded focus groups, conducted in four outpatient pediatric diabetes clinics in large regional hospitals in England. Participants comprised four groups of parents (n = 22) and youth (n = 17) with type 1 diabetes, purposively sampled on the basis of past involvement (either participation or nonparticipation) in an ongoing two-arm randomized trial comparing multiple daily injection with conventional continuous subcutaneous insulin infusion regimens from the onset of type 1 diabetes. RESULTS: Stress associated with diagnosis presents significant challenges in terms of study recruitment, with parents demonstrating varied levels of willingness to be approached soon after diagnosis. Additional challenges arise regarding the following: randomization when study arms are perceived as sharply differentiated in terms of therapy effectiveness; burdens arising from study participation; and the need to surrender new technologies following the end of the study. However, these challenges were mostly insufficient to rule out study participation. Participants emphasized the benefits and reassurance arising from support provided by staff and fellow study participants. CONCLUSIONS: Recruitment to studies of new diabetes technologies immediately after diagnosis in youth presents significant challenges, but these are not insurmountable. The stress and uncertainty arising from potential participation may be alleviated by personalized discussion with staff and peer support from fellow study participants.

Blended e-learning and end of life care in nursing homes: a small-scale mixed-methods case study.

BACKGROUND: A 'blended' (e-learning and facilitated workshops) training course for Group C staff (i.e. staff with relatively infrequent contact with end of life care) has been delivered across several English counties with the aim of improving end of life care in nursing and residential care homes. This paper evaluates the impact of the course on participants' understandings of and confidence in delivering end of life care in one nursing home, while also considering barriers to change in practice. METHODS: A mixed-methods case study approach, incorporating pre- and post-course questionnaires (SHA East of England End of Life Care Education Programme 'ABC' Project Work Force C or Non Nurse Workforce B Pre and Post Course Questionnaire; E-Learning in End of Life Care Study Pre and Post Course Questionnaire), documentary analysis, semi-structured interviews, and observation of course workshops. Participants were 20 members of staff at a nursing home in a city in the East of England, including 14 Health Care Assistants (carers) and 6 others (administrative, activities, hosting, and catering staff). The questionnaires and interviews assessed understandings of and confidence towards end of life care delivery. RESULTS: Improvements in participants' confidence in delivering end of life care were observed, particularly in the core competency areas of symptom management, communication, and advance care planning. A shift towards more detailed and more holistic understandings of end of life care was in evidence; some participants also championed end of life care in the home as a result of the course. Several barriers to changes in practice were encountered, including uneven participation, the absence of mechanisms for disseminating new insights and knowledge within the home, and a widespread perception that nurses' professional dominance in the home made sustainable change difficult to enact. CONCLUSIONS: While blended e-learning courses have the potential to generate positive change in participants' understandings of and confidence about End of Life Care, organizational and inter-professional obstacles must be overcome in order to translate these changes into improved end of life care delivery in nursing (and residential) homes.

mHealth and global mental health: still waiting for the mH2 wedding?

BACKGROUND: Two phenomena have become increasingly visible over the past decade: the significant global burden of disease arising from mental illness and the rapid acceleration of mobile phone usage in poorer countries. Mental ill-health accounts for a significant proportion of global disability-adjusted life years (DALYs) and years lived with disability (YLDs), especially in poorer countries where a number of factors combine to exacerbate issues of undertreatment. Yet poorer countries have also witnessed significant investments in, and dramatic expansions of, mobile coverage and usage over the past decade. DEBATE: The conjunction of high levels of mental illness and high levels of mobile phone usage in poorer countries highlights the potential for "mH(2)" interventions--i.e. mHealth (mobile technology-based) mental health interventions--to tackle global mental health challenges. However, global mental health movements and initiatives have yet to engage fully with this potential, partly because of scepticism towards technological solutions in general and partly because existing mH(2) projects in mental health have often taken place in a fragmented, narrowly-focused, and small-scale manner. We argue for a deeper and more sustained engagement with mobile phone technology in the global mental health context, and outline the possible shape of an integrated mH(2) platform for the diagnosis, treatment, and monitoring of mental health. SUMMARY: Existing and developing mH(2) technologies represent an underutilised resource in global mental health. If development, evaluation, and implementation challenges are overcome, an integrated mH2 platform would make significant contributions to mental healthcare in multiple settings and contexts.

A global model for effective use and evaluation of e-learning in health.

Healthcare systems worldwide face a wide range of challenges, including demographic change, rising drug and medical technology costs, and persistent and widening health inequalities both within and between countries. Simultaneously, issues such as professional silos, static medical curricula, and perceptions of "information overload" have made it difficult for medical training and continued professional development (CPD) to adapt to the changing needs of healthcare professionals in increasingly patient-centered, collaborative, and/or remote delivery contexts. In response to these challenges, increasing numbers of medical education and CPD programs have adopted e-learning approaches, which have been shown to provide flexible, low-cost, user-centered, and easily updated learning. The effectiveness of e-learning varies from context to context, however, and has also been shown to make considerable demands on users' motivation and "digital literacy" and on providing institutions. Consequently, there is a need to evaluate the effectiveness of e-learning in healthcare as part of ongoing quality improvement efforts. This article outlines the key issues for developing successful models for analyzing e-health learning.