Switching to once-weekly insulin icodec versus once-daily insulin glargine U100 in individuals with basal-bolus insulin-treated type 2 diabetes (ONWARDS 4): a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial.

BACKGROUND: Insulin icodec (icodec) is a basal insulin analogue suitable for once-weekly dosing. ONWARDS 4 aimed to assess the efficacy and safety of once-weekly icodec compared with once-daily insulin glargine U100 (glargine U100) in individuals with long-standing type 2 diabetes on a basal-bolus regimen. METHODS: In this 26-week, phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial, adults from 80 sites (outpatient clinics and hospital departments) across nine countries (Belgium, India, Italy, Japan, Mexico, the Netherlands, Romania, Russia, and the USA) with type 2 diabetes (glycated haemoglobin [HbA1c] 7·0-10·0%) were randomly assigned (1:1) to receive once-weekly icodec or once-daily glargine U100 combined with 2-4 daily bolus insulin aspart injections. The primary outcome was change in HbA1c from baseline to week 26 (non-inferiority margin of 0·3 percentage points). The primary outcome was evaluated in the full analysis set (ie, all randomly assigned participants). Safety outcomes were evaluated in the safety analysis set (ie, all participants randomly assigned who received at least one dose of trial product). This trial is registered with ClinicalTrials.gov, NCT04880850. FINDINGS: Between May 14 and Oct 29, 2021, 746 participants were screened for eligibility, of whom 582 (78%) were randomly assigned (291 [50%] to icodec treatment and 291 [50%] to glargine U100 treatment). Participants had a mean duration of type 2 diabetes of 17·1 years (SD 8·4). At week 26, estimated mean change in HbA1c was -1·16 percentage points in the icodec group (baseline 8·29%) and -1·18 percentage points in the glargine U100 group (baseline 8·31%), showing non-inferiority for icodec versus glargine U100 (estimated treatment difference 0·02 percentage points [95% CI -0·11 to 0·15], p<0·0001). Overall, 171 (59%) of 291 participants in the icodec group and 167 (57%) of 291 participants in the glargine U100 group had an adverse event. 35 serious adverse events were reported in 22 (8%) of 291 participants in the icodec group and 33 serious adverse events were reported in 25 (9%) of 291 participants receiving glargine U100. Overall, combined level 2 and level 3 hypoglycaemia rates were similar between treatment groups. No new safety concerns were identified for icodec. INTERPRETATION: In people with long-standing type 2 diabetes on a basal-bolus regimen, once-weekly icodec showed similar improvements in glycaemic control, with fewer basal insulin injections, lower bolus insulin dose, and with no increase in hypoglycaemic rates compared with once-daily glargine U100. Key strengths of this trial include the use of masked continous glucose monitoring; the high trial completion rate; and the inclusion of a large, diverse, and multinational population. Limitations include the relatively short trial duration and the open-label design. FUNDING: Novo Nordisk.

Frequency of hypoglycaemia with basal insulin treatments in adults with type 1 diabetes treated with basal-bolus insulin regimens in treat-to-target trials: A narrative review.

AIM: To summarise, in a narrative review, published data on hypoglycaemia occurrence with basal insulin therapy in adults with type 1 diabetes treated with basal-bolus insulin regimens in treat-to-target randomised controlled trials. METHODS: Data were included from 21 eligible trials, which mainly used self-measured blood glucose or plasma glucose to detect hypoglycaemia. RESULTS: All-day self-measured blood glucose or plasma glucose level 2 (glucose threshold of 3.1 or 3.0 mmol/L) and level 3 (severe, requiring assistance) hypoglycaemic events were reported, respectively, by a range of 69.0%-97.5% and 0%-13.4% adults when receiving basal-bolus insulin therapy, with rates of 10.6-68.1 and 0.0-0.4 events per patient-year of exposure, respectively. Hypoglycaemia rates measured using continuous glucose monitoring (three studies) were numerically, yet consistently, higher than with either other method, except when limiting to symptomatic events. Nocturnal hypoglycaemia rates were generally less than 30% of the equivalent all-day rates. CONCLUSIONS: Differences across the studies in design (e.g., titration targets) and participant characteristics hindered comparison of hypoglycaemia rates by insulin formulation. Consequently, few trends were identified by insulin formulation, study methodology or individuals' characteristics, suggesting that further research is required to identify treatment strategies that facilitate development of individualised recommendations to lower hypoglycaemia risk. These findings are useful to understand hypoglycaemia risk with available basal insulin therapies when used in a multiple daily injection regimen, as well as to provide context for the results of ongoing and future clinical trials, including those for two once-weekly basal insulins, insulin icodec and basal insulin Fc.

Basal Insulin Degludec and Glycemic Control Compared to Aspart Via Insulin Pump in Type 1 Diabetes (BIGLEAP): A Single-Center, Open-Label, Randomized, Crossover Trial.

OBJECTIVE: We compared the efficacy of the second-generation basal insulin degludec (IDeg) to that of insulin aspart via pump using continuous glucose monitoring in patients with well-controlled type 1 diabetes. METHODS: In this 40-week, single-center, randomized, crossover-controlled trial, adults with well-controlled type 1 diabetes (hemoglobin A1C of <7.5% [<58 mmol/mol]) (N = 52) who were using an insulin pump and continuous glucose monitoring were randomized to 1 of 2 treatments for a 20-week period: a single daily injection of IDeg with bolus aspart via pump or a continuous subcutaneous insulin infusion (CSII) with aspart, followed by crossover to the other treatment. The primary endpoint was time in range (70-180 mg/dL) during the final 2 weeks of each treatment period. RESULTS: Fifty-two patients were randomized and completed both treatment periods. The time in range for IDeg and CSII was 71.5% and 70.9%, respectively (P = .553). The time in level 1 hypoglycemia for the 24-hour period with IDeg and CSII was 2.19% and 1.75%, respectively (P = .065). The time in level 2 hypoglycemia for the 24-hour period with IDeg and CSII was 0.355% and 0.271%, respectively (P = .212), and the nocturnal period was 0.330% and 0.381%, respectively (P = .639). The mean standard deviation of blood glucose levels for the 24-hour period for IDeg and CSII was 52.4 mg/dL and 51.0 mg/dL, respectively (P = .294). The final hemoglobin A1C level for each treatment was 7.04% (53 mmol/mol) with IDeg, and 6.95% (52 mmol/mol) with CSII (P = .288). Adverse events were similar between treatments. CONCLUSION: We observed similar glycemic control between IDeg and insulin aspart via CSII for basal insulin coverage in patients with well-controlled type 1 diabetes.

Social determinants of health, personalized medicine, and child maltreatment.

This review begins with a brief summary of the importance of child maltreatment as a major public health problem, given its prevalence and the substantial human and economic costs involved. The focus then shifts to consideration of personalized medicine and child maltreatment, including genetic and genomics factors, as well as the role of social determinants of health. Research on epigenetics related to child abuse and neglect is presented, followed by that pertaining to a few specific social factors, such as poverty, parental depression and substance use, and domestic (or intimate partner) violence. The review ends with a discussion of interventions to help address social determinants of health with brief descriptions of several model programs, and thoughts concerning the role of personalized medicine in addressing child maltreatment in the foreseeable future. IMPACT: This paper synthesizes knowledge on social determinants of health and advances in genetics and genomics related to the prevention of child maltreatment. It provides examples of model approaches to addressing the prevention of child maltreatment in primary care practices.

Interorganizational Knowledge Sharing to Establish Digital Health Learning Ecosystems: Qualitative Evaluation of a National Digital Health Transformation Program in England.

BACKGROUND: The English Global Digital Exemplar (GDE) program is one of the first concerted efforts to create a digital health learning ecosystem across a national health service. OBJECTIVE: This study aims to explore mechanisms that support or inhibit the exchange of interorganizational digital transformation knowledge. METHODS: We conducted a formative qualitative evaluation of the GDE program. We used semistructured interviews with clinical, technical, and managerial staff; national program managers and network leaders; nonparticipant observations of knowledge transfer activities through attending meetings, workshops, and conferences; and documentary analysis of policy documents. The data were thematically analyzed by drawing on a theory-informed sociotechnical coding framework. We used a mixture of deductive and inductive methods, supported by NVivo software, to facilitate coding. RESULTS: We conducted 341 one-on-one and 116 group interviews, observed 86 meetings, and analyzed 245 documents from 36 participating provider organizations. We also conducted 51 high-level interviews with policy makers and vendors; performed 77 observations of national meetings, workshops, and conferences; and analyzed 80 national documents. Formal processes put in place by the GDE program to initiate and reinforce knowledge transfer and learning have accelerated the growth of informal knowledge networking and helped establish the foundations of a learning ecosystem. However, formal networks were most effective when supported by informal networking. The benefits of networking were enhanced (and costs reduced) by geographical proximity, shared culture and context, common technological functionality, regional and strategic alignments, and professional agendas. CONCLUSIONS: Knowledge exchange is most effective when sustained through informal networking driven by the mutual benefits of sharing knowledge and convergence between group members in their organizational and technological setting and goals. Policy interventions need to enhance incentives and reduce barriers to sharing across the ecosystem, be flexible in tailoring formal interventions to emerging needs, and promote informal knowledge sharing.

Exploring the Burden of Mealtime Insulin Dosing in Adults and Children With Type 1 Diabetes.

Timely and accurate mealtime insulin dosing can be an ongoing challenge for people with type 1 diabetes. This multinational, online study aimed to explore attitudes and behaviors around mealtime insulin dosing and the impact of mealtime dose timing, particularly with regard to premeal dosing (15-20 minutes before a meal). Although the majority of surveyed participants (96%) recognized the importance of accurate mealtime bolus insulin dosing, only a small proportion (35%) reported being "very confident" in accurate bolus insulin estimation. Given the choice, the majority of participants would prefer to administer insulin immediately before or after a meal, as this timing would improve their quality of life.

The relationship between HbA1c and hypoglycaemia in patients with diabetes treated with insulin degludec versus insulin glargine 100 units/mL.

AIM: Treat-to-target, randomized controlled trials have confirmed lower rates of hypoglycaemia at equivalent glycaemic control with insulin degludec (degludec) versus insulin glargine 100 units/mL (glargine U100) in patients with type 1 (T1D) or type 2 diabetes (T2D). Treat-to-target trials are designed to enable comparisons of safety and tolerability at a similar HbA1c level. In this post hoc analysis of the SWITCH 1 and 2 trials, we utilised a patient-level modelling approach to compare how glycaemic control might differ between basal insulins at a similar rate of hypoglycaemia. MATERIALS AND METHODS: Data for HbA1c and symptomatic hypoglycaemia from the SWITCH 1 and SWITCH 2 trials were analyzed separately for patients with type 1 diabetes and type 2 diabetes, respectively. The association between the individual patient-level risk of hypoglycaemia and HbA1c was investigated using a Poisson regression model and used to estimate potential differences in glycaemic control with degludec versus glargine U100, at the same rate of hypoglycaemia. RESULTS: Improvements in glycaemic control increased the incidence of hypoglycaemia with both basal insulins across diabetes types. Our analysis suggests that patients could achieve a mean HbA1c reduction of 0.70 [0.05; 2.20]95% CI (for type 1 diabetes) or 0.96 [0.39; 1.99]95% CI (for type 2 diabetes) percentage points (8 [1; 24]95% CI or 10 [4; 22]95% CI mmol/mol, respectively) further with degludec than with glargine U100 before incurring an equivalent risk of hypoglycaemia. CONCLUSION: Our findings suggest that patients in clinical practice may be able to achieve lower glycaemia targets with degludec versus glargine U100, before incurring an equivalent risk of hypoglycaemia.

Theoretical and methodological considerations in evaluating large-scale health information technology change programmes.

BACKGROUND: Attempts to achieve digital transformation across the health service have stimulated increasingly large-scale and more complex change programmes. These encompass a growing range of functions in multiple locations across the system and may take place over extended timeframes. This calls for new approaches to evaluate these programmes. MAIN BODY: Drawing on over a decade of conducting formative and summative evaluations of health information technologies, we here build on previous work detailing evaluation challenges and ways to tackle these. Important considerations include changing organisational, economic, political, vendor and markets necessitating tracing of evolving networks, relationships, and processes; exploring mechanisms of spread; and studying selected settings in depth to understand local tensions and priorities. CONCLUSIONS: Decision-makers need to recognise that formative evaluations, if built on solid theoretical and methodological foundations, can help to mitigate risks and help to ensure that programmes have maximum chances of success.

Technological Capabilities to Assess Digital Excellence in Hospitals in High Performing Health Care Systems: International eDelphi Exercise.

BACKGROUND: Hospitals worldwide are developing ambitious digital transformation programs as part of broader efforts to create digitally advanced health care systems. However, there is as yet no consensus on how best to characterize and assess digital excellence in hospitals. OBJECTIVE: Our aim was to develop an international agreement on a defined set of technological capabilities to assess digital excellence in hospitals. METHODS: We conducted a two-stage international modified electronic Delphi (eDelphi) consensus-building exercise, which included a qualitative analysis of free-text responses. In total, 31 international health informatics experts participated, representing clinical, academic, public, and vendor organizations. RESULTS: We identified 35 technological capabilities that indicate digital excellence in hospitals. These are divided into two categories: (a) capabilities within a hospital (n=20) and (b) capabilities enabling communication with other parts of the health and social care system, and with patients and carers (n=15). The analysis of free-text responses pointed to the importance of nontechnological aspects of digitally enabled change, including social and organizational factors. Examples included an institutional culture characterized by a willingness to transform established ways of working and openness to risk-taking. The availability of a range of skills within digitization teams, including technological, project management and business expertise, and availability of resources to support hospital staff, were also highlighted. CONCLUSIONS: We have identified a set of criteria for assessing digital excellence in hospitals. Our findings highlight the need to broaden the focus from technical functionalities to wider digital transformation capabilities.

Day-to-day fasting self-monitored blood glucose variability is associated with risk of hypoglycaemia in insulin-treated patients with type 1 and type 2 diabetes: A post hoc analysis of the SWITCH Trials.

AIMS: To investigate the association between day-to-day fasting self-monitored blood glucose (SMBG) variability and risk of hypoglycaemia in type 1 (T1D) and type 2 diabetes (T2D), and to compare day-to-day fasting SMBG variability between treatments with insulin degludec (degludec) and insulin glargine 100 units/mL (glargine U100). MATERIALS AND METHODS: Data were retrieved from two double-blind, randomized, treat-to-target, two-period (32 weeks each) crossover trials of degludec vs glargine U100 in T1D (SWITCH 1, n = 501) and T2D (SWITCH 2, n = 720). Available fasting SMBGs were used to determine the standard deviation (SD) of day-to-day fasting SMBG variability for each patient and the treatment combination. The association between day-to-day fasting SMBG variability and overall symptomatic, nocturnal symptomatic and severe hypoglycaemia was analysed for the pooled population using linear regression, with fasting SMBG variability included as a three-level factor defined by population tertiles. Finally, day-to-day fasting SMBG variability was compared between treatments. RESULTS: Linear regression showed that day-to-day fasting SMBG variability was significantly associated with overall symptomatic, nocturnal symptomatic and severe hypoglycaemia risk in T1D and T2D (P < 0.05). Day-to-day fasting SMBG variability was significantly associated (P < 0.01) with all categories of hypoglycaemia risk, with the exception of severe hypoglycaemia in T2D when analysed within tertiles. Degludec was associated with 4% lower day-to-day fasting SMBG variability than glargine U100 in T1D (P = 0.0082) and with 10% lower day-to-day fasting SMBG variability in T2D (P < 0.0001). CONCLUSIONS: Higher day-to-day fasting SMBG variability is associated with an increased risk of overall symptomatic, nocturnal symptomatic and severe hypoglycaemia. Degludec has significantly lower day-to-day fasting SMBG variability vs glargine U100.

A randomized, multicentre trial evaluating the efficacy and safety of fast-acting insulin aspart in continuous subcutaneous insulin infusion in adults with type 1 diabetes (onset 5).

AIM: To evaluate the efficacy and safety of fast-acting insulin aspart (faster aspart) vs insulin aspart (IAsp) used in continuous subcutaneous insulin infusion (CSII) in participants with type 1 diabetes (T1D). MATERIALS AND METHODS: This was a double-blind, treat-to-target, randomized, 16-week trial investigating CSII treatment with faster aspart (n = 236) or IAsp (n = 236). All available information, regardless of treatment discontinuation, was used for the evaluation of effect. RESULTS: Faster aspart was non-inferior to IAsp regarding the change from baseline in glycated haemoglobin (HbA1c; primary endpoint). The mean HbA1c changed from 58.4 mmol/mol (7.5%) at baseline to 57.8 mmol/mol (7.4%) with faster aspart and to 56.8 mmol/mol (7.4%) with IAsp after 16 weeks' treatment, with an estimated treatment difference (ETD) of 1.0 mmol/mol (95% confidence interval [CI] 0.14; 1.87) or 0.09% (95% CI 0.01; 0.17; P < 0.001) for non-inferiority (0.4% margin; P < 0.02 for statistical significance in favour of IAsp). Faster aspart was superior to IAsp in change from baseline in 1-hour postprandial glucose (PPG) increment after a meal test (ETD -0.91 mmol/L [95% CI -1.43; -0.39] or -16.4 mg/dL [95% CI -25.7; -7.0]; P = 0.001), with statistically significant reductions also at 30 minutes and 2 hours. The improvement in PPG was reflected in the change from baseline in 1-hour interstitial glucose increment after all meals (ETD -0.21 mmol/L [95% CI -0.31; -0.11] or -3.77 mg/dL [95% CI -5.53; -2.01]). There was no statistically significant difference in the overall rate of severe or blood glucose-confirmed hypoglycaemia (estimated rate ratio 1.00 [95% CI 0.85; 1.16]). A numerical imbalance in severe hypoglycaemic episodes between faster aspart and IAsp was seen in the treatment (21 vs 7) and 4-week run-in periods (4 vs 0). CONCLUSIONS: Faster aspart provides an effective and safe option for CSII treatment in T1D.

Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 1 Diabetes: The SWITCH 1 Randomized Clinical Trial.

IMPORTANCE: Hypoglycemia, common in patients with type 1 diabetes, is a major barrier to achieving good glycemic control. Severe hypoglycemia can lead to coma or death. OBJECTIVE: To determine whether insulin degludec is noninferior or superior to insulin glargine U100 in reducing the rate of symptomatic hypoglycemic episodes. DESIGN, SETTING, AND PARTICIPANTS: Double-blind, randomized, crossover noninferiority trial involving 501 adults with at least 1 hypoglycemia risk factor treated at 84 US and 6 Polish centers (January 2014-January 12, 2016) for two 32-week treatment periods, each with a 16-week titration and a 16-week maintenance period. INTERVENTIONS: Patients were randomized 1:1 to receive once-daily insulin degludec followed by insulin glargine U100 (n = 249) or to receive insulin glargine U100 followed by insulin degludec (n = 252) and randomized 1:1 to morning or evening dosing within each treatment sequence. MAIN OUTCOMES AND MEASURES: The primary end point was the rate of overall severe or blood glucose-confirmed (<56 mg/dL) symptomatic hypoglycemic episodes during the maintenance period. Secondary end points included the rate of nocturnal symptomatic hypoglycemic episodes and proportion of patients with severe hypoglycemia during the maintenance period. The noninferiority criterion for the primary end point and for the secondary end point of nocturnal hypoglycemia was defined as an upper limit of the 2-sided 95% CI for a rate ratio of 1.10 or lower; if noninferiority was established, 2-sided statistical testing for superiority was conducted. RESULTS: Of the 501 patients randomized (mean age, 45.9 years; 53.7% men), 395 (78.8%) completed the trial. During the maintenance period, the rates of overall symptomatic hypoglycemia were 2200.9 episodes per 100 person-years' exposure (PYE) in the insulin degludec group vs 2462.7 episodes per 100 PYE in the insulin glargine U100 group for a rate ratio (RR) of 0.89 (95% CI, 0.85-0.94; P < .001 for noninferiority; P < .001 for superiority; rate difference, -130.31 episodes per 100 PYE; 95% CI, -193.5 to -67.16). The rates of nocturnal symptomatic hypoglycemia were 277.1 per 100 PYE in the insulin degludec group vs 428.6 episodes per 100 PYE in the insulin glargine U100 group, for an RR of 0.64 (95% CI, 0.56-0.73; P < .001 for noninferiority; P < .001 for superiority; rate difference, -61.94 episodes per 100 PYE; 95% CI, -83.85 to -40.03). A lower proportion of patients in the insulin degludec than in the insulin glargine U100 group experienced severe hypoglycemia during the maintenance period (10.3%, 95% CI, 7.3%-13.3% vs 17.1%, 95% CI, 13.4%-20.8%, respectively; McNemar P = .002; risk difference, -6.8%; 95% CI, -10.8% to -2.7%). CONCLUSIONS AND RELEVANCE: Among patients with type 1 diabetes and at least 1 risk factor for hypoglycemia, 32 weeks' treatment with insulin degludec vs insulin glargine U100 resulted in a reduced rate of overall symptomatic hypoglycemic episodes. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02034513.

Reduced risk of hypoglycemia with insulin degludec versus insulin glargine in patients with type 2 diabetes requiring high doses of basal insulin: a meta-analysis of 5 randomized begin trials.

OBJECTIVE: This meta-analysis of 5 trials from the Phase 3a insulin degludec (IDeg) clinical trial program evaluated the risk of hypoglycemia in a subset of subjects with type 2 diabetes (T2D) who required high basal insulin doses at the end of the trials. METHODS: This meta-analysis compared glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), basal insulin dose, body weight, and rates of overall and nocturnal confirmed hypoglycemia in a pooled population of T2D subjects using >60 U basal insulin at trial completion. Five Phase 3a, open-label, randomized, treat-to-target, confirmatory 26- or 52-week trials with IDeg (n = 2,262) versus insulin glargine (IGlar) (n = 1,110) administered once daily were included. Overall confirmed hypoglycemia was defined as self-measured blood glucose >56 mg/dL or any episode requiring assistance; nocturnal confirmed hypoglycemia had an onset between 00:01 and 05:59 AM. RESULTS: More than one-third of IDeg- (35%) and IGlar- (34%) treated T2D subjects required >60 U of basal insulin daily at the ends of the trial. Patients achieved similar mean HbA1c values (estimated treatment difference [ETD] IDeg - IGlar: 0.05%, P = .44) while mean FPG values were lower with IDeg than IGlar (ETD: -5.9 mg/dL, P = .04) at end-of-trial. There was a 21% lower rate of overall confirmed hypoglycemic episodes for IDeg (estimated rate ratio [RR] IDeg/IGlar: 0.79, P = .02) and a 52% lower rate of nocturnal confirmed hypoglycemic episodes for IDeg (RR: 0.48, P<.01). CONCLUSION: In this post hoc meta-analysis, more than 30% of subjects with T2D required >60 U/day of basal insulin at the end of the trials. In these individuals, IDeg achieves similar HbA1c reduction with significantly less overall and nocturnal confirmed hypoglycemia compared with IGlar.

Prevalence, trends, and factors associated with maternal autonomy regarding healthcare, finances, and mobility in Bangladesh: Analysis of Demographic and Health Surveys 1999-2018.

Maternal autonomy is associated with improved healthcare utilization/outcomes for mothers and babies in low- and middle-income countries. We investigated the trends in the prevalence and factors associated with maternal autonomy in Bangladesh. This cross-sectional study analyzed the Bangladesh Demographic and Health Survey for 1999-00, 2004, 2007, 2011, 2014, and 2017-18. Maternal autonomy was defined as at least one decision-making ability regarding healthcare, large household purchases, and freedom of mobility. We included 15-49-year-old mothers with at least one live-birth in the past three years. We compared the samples based on the presence of autonomy and reported the trends in prevalence (95% confidence intervals (CIs)) across the survey years. Lastly, we performed multilevel logistic regression to report prevalence odds ratios (PORs) for the associated factors. Variables investigated as potential factors included maternal age, number of children, maternal education, paternal education, current work, religion, mass media exposure, wealth quintile, place and division of residence, and survey years. The prevalence of 'any' maternal autonomy was 72.0% (95% CI: 70.5-73.5) in 1999-00 and increased to 83.8% (95% CI: 82.7-84.9) in 2017-18. In adjusted analysis, mothers with older age, higher education, work outside the home, and mass media exposure had higher odds of autonomy than their counterparts (POR > 1, p < 0.05). For instance, compared to mothers without any formal education, the odds of autonomy were significantly (p < 0.001) higher among mothers with primary (adjusted POR: 1.2, 95% CI: 1.1-1.4), secondary (adjusted POR: 1.4, 95% CI: 1.2-1.6), and college/above (adjusted POR: 1.9, 95% CI: 1.6-2.2) education. While the level of maternal autonomy has increased, a substantial proportion still do not have autonomy. Expanding educational and earning opportunities may increase maternal autonomy. Further research should investigate other ways to improve it as well.

How Should Clinicians and Health Care Organizations Promote Equity in Child Abuse and Neglect Suspicion, Evaluation, and Reporting?

Victims of child abuse and neglect come from every racial, ethnic, and socioeconomic background, yet clinical evaluation, reporting to child protective services, and responses to reports inequitably harm Black children and malign families of color. Racial bias and inequity in suspicion, reporting, and substantiation of abuse and neglect and in services offered and delivered, foster care placement, and criminal prosecution are widely documented. In response, clinicians and health care organizations should promote equity by educating clinicians about racial bias, standardizing evaluation using clinical decision support tools, and working with policy makers to support prevention services. If we decide that it is ethically justifiable for clinicians to err on the side of overreporting, we must ensure fair distribution of associated benefits and harms among all children and families.

Effective Overall Glycaemic Control with Fast-Acting Insulin Aspart Across Patients with Different Baseline Characteristics: A Post Hoc Analysis of the Onset 9 Trial.

AIMS: To investigate the efficacy and safety of fast-acting insulin aspart (faster aspart) compared with insulin aspart (IAsp) in participants with type 2 diabetes (T2D) across different subgroups. METHODS: We report on a post hoc analysis of onset 9, a 16-week trial of participants with T2D randomised to faster aspart (n = 546) or IAsp (n = 545). Participants were grouped by baseline HbA1c (< 7.0%, ≥ 7.0%), meal test bolus insulin dose (≤ 10 units [U], > 10 U to ≤ 20 U, > 20 U), body mass index (< 30 kg/m2, ≥ 30 to < 35 kg/m2, ≥ 35 kg/m2), and age (< 65 years, ≥ 65 years). Outcomes assessed were change from baseline in HbA1c and in 1-h postprandial glucose (PPG) increment, and severe or blood glucose (BG)-confirmed hypoglycaemia. RESULTS: Faster aspart provided reductions in HbA1c comparable to IAsp across all subgroups, with improved 1-h PPG control compared with IAsp in several subgroups. Faster aspart had comparable or improved rates of severe or BG-confirmed hypoglycaemia versus IAsp, particularly in participants with good glycaemic control (HbA1c < 7.0%), the elderly (≥ 65 years old), and those with insulin resistance (> 20 U meal test bolus insulin dose). CONCLUSIONS: Faster aspart provides effective overall glycaemic control, with improved early PPG control compared with IAsp across a range of patient characteristics. CLINICAL TRIAL REGISTRATION: NCT03268005.

Fast-acting insulin aspart (faster aspart) is a type of insulin used at mealtimes to reduce the spike in blood sugar resulting from that meal. Faster aspart works in the body more quickly and more effectively than insulin aspart (IAsp), the previous version of this insulin. The properties of insulins in the body can change according to certain patient characteristics. In this study, the researchers wanted to find out if there were differences between various subgroups of patients in the effectiveness and safety of faster aspart compared with IAsp in the treatment of type 2 diabetes. Data were used from a clinical trial (onset 9), in which 546 patients were treated with faster aspart and 545 were treated with IAsp. Patients were grouped by baseline glycated haemoglobin (HbA1c), meal test actual bolus insulin dose, body mass index, and age. Faster aspart provided reductions in HbA1c comparable to IAsp across all subgroups, with improved glucose control 1 hour after a meal compared with IAsp, in several subgroups. Faster aspart had comparable or improved rates of hypoglycaemia versus IAsp, particularly in participants with good glucose control, the elderly (≥ 65 years old), and those with insulin resistance. In summary, the researchers found that faster aspart provides effective overall glucose control, with improved early mealtime glucose control compared with IAsp across patients with a range of baseline characteristics.

Benefits realization management in the context of a national digital transformation initiative in English provider organizations.

BACKGROUND: The Global Digital Exemplar (GDE) Programme is a national initiative to promote digitally enabled transformation in English provider organizations. The Programme applied benefits realization management techniques to promote and demonstrate transformative outcomes. This work was part of an independent national evaluation of the GDE Programme. AIMS: We explored how benefits realization management was approached and conceptualized in the GDE Programme. METHODS: We conducted a series of 36 longitudinal case studies of provider organizations participating in the GDE Programme, 12 of which were in depth. Data collection included a combination of 628 interviews (with implementation staff in provider organizations, national programme management staff, and suppliers), 499 documents (of national and local implementation plans and lessons learned), and 190 nonparticipant observations (of national and local programme management meetings to develop insights into the broader context of benefits realization activities, tensions arising, and how these were negotiated). Data were coded drawing on a sociotechnical framework developed in related work and thematically analyzed, initially within and then across cases, with the help of NVivo 11 software. RESULTS: Most stakeholders broadly agreed with the rationale of benefits realization in the GDE Programme to show due diligence that public money was appropriately spent, and to develop an evidence base supporting the value of digitally enabled transformation. Differing national and local reporting purposes, however, created tensions. Central requirements, for progress reporting and tracking high-level benefits, had limited perceived local value and were seen to impose an unnecessary burden on provider organizations. This was accentuated by the lack of harmonization of reporting requirements to different stakeholders (which differed in content and timing). There were tensions between the desire for early evidence of outcomes and the slow processes of infrastructural change (which created problems of attribution of benefits to causes as benefits emerged gradually and over long timeframes), and also between reporting immediately visible local changes and showing how these flowed through to high level organization wide benefits (eg, in terms of health outcomes or cost savings/return on investment). The attempt to fulfill these diverging agendas and informational needs within a single reporting tool had limited success. These difficulties were mitigated by efforts to simplify reporting requirements and to support targeted collection of key national outcome measures. Although progress was hampered by an initial lack of benefits realization expertise in provider organizations, some providers subsequently retained these skills for their own change management purposes. CONCLUSIONS: There is a need to recognize the limitations and cost of benefits realization management practices in the context of healthcare digitalization where benefits may materialize over long timeframes and in unanticipated ways. Although diverse stakeholder information needs may create tensions, prior agreement about rationales for collecting information and a targeted approach to tracking local and high-level benefits may enhance local relevance, reduce perceived reporting burdens, and improve acceptance/effectiveness. A single integrated reporting mechanism is unlikely to fulfill both national and local requirements.

Cost effectiveness of SEEK: A primary care-based child maltreatment prevention model.

BACKGROUND: Funding for prevention interventions is often quite limited. Cost-related assessments are important to best allocate prevention funds. OBJECTIVES: To determine the (1) overall cost for implementing the Safe Environment for Every Kid (SEEK) model, (2) cost of implementation per child, and (3) cost per case of maltreatment averted. DESIGN: Cost-effective analysis of a randomized controlled trial. PARTICIPANTS AND SETTING: 102 pediatric providers at 18 pediatric primary care practices. 924 families with children < 6 years receiving care by those providers. METHODS: Practices and their providers were randomized to either SEEK training and implementation or usual care. Families in SEEK and control practices were recruited for evaluation. Rates of psychological and physical abuse were calculated by parent self-report 12 months following recruitment. Model costs were calculated including salaries for team members, provider time for training and booster sessions, and development and distribution of materials. RESULTS: Implementing SEEK in all 18 practices would have cost approximately $265,892 over 2.5 years; $3.59 per child per year; or $305.58 ($229.18-$381.97) to prevent one incident. Based on a very conservative cost estimate of $2779 per maltreatment incident, SEEK would save an estimated $2,151,878 in health care costs for 29,610 children. CONCLUSIONS: The SEEK model is cost saving. Cost per case of psychological and physical abuse averted were significantly lower than the short-term costs of medical and mental health care for maltreated children. SEEK model expansion has the potential to significantly decrease medical, mental health, and other related costs associated with maltreatment.