Insulin Use During Gestational and Pre-existing Diabetes in Pregnancy: A Systematic Review of Study Design.

INTRODUCTION: Insulin is the first-line pharmacologic therapy for women with diabetes in pregnancy. However, conducting well-designed randomized clinical trials (RCTs) and achieving recommended glycemic targets remains a challenge for this unique population. This systematic literature review (SLR) aimed to understand the evidence for insulin use in pregnancy and the outcome metrics most often used to characterize its effect on glycemic, maternal and fetal outcomes in gestational diabetes mellitus (GDM) and in pregnant women with diabetes. METHODS: An SLR was conducted using electronic databases in Medline, EMBASE via Ovid platform, evidence-based medicine reviews (2010-2020) and conference proceedings (2018-2019). Studies were included if they assessed the effect of insulin treatment on glycemic, maternal or fetal outcomes in women with diabetes in pregnancy. Studies on any type of diabetes other than gestational or pre-existing diabetes as well as non-human studies were excluded. RESULTS: In women diagnosed with GDM or pre-existing diabetes, most studies compared treatment of insulin with metformin (n = 35) followed by diet along with lifestyle intervention (n = 24) and glibenclamide (n = 12). Most studies reporting on glycemic outcomes compared insulin with metformin (n = 22) and glibenclamide (n = 4). Fasting blood glucose was the most reported clinical outcome of interest. Among the studies reporting maternal outcomes, method of delivery and delivery complications were most commonly reported. Large for gestational age, stillbirth and perinatal mortality were the most common fetal outcomes reported. CONCLUSION: This SLR included a total of 108 clinical trials and observational studies with diverse populations and treatment arms. Outcomes varied across the studies, and a lack of consistent outcome measures to manage diabetes in pregnant women was observed. This elucidates a need for global consensus on study design and standardized clinical, maternal and fetal outcomes metrics.

The Impact of Substantial Improvements in HbA1c and Weight Loss on the Medication Preferences of People with Type 2 Diabetes.

Purpose: To quantify the preferences of people with type 2 diabetes (T2D) for treatment attributes of a glucose-dependent insulinotropic polypeptide (GIP)/glucagon-like peptide-1 (GLP-1) receptor agonist (RA) versus an injectable GLP-1 RA medication profile. Patients and Methods: Injection-naive people taking oral medications for T2D in the US and UK completed a web survey including a discrete choice experiment to quantify patients' preferences for five treatment attributes: delivery system, frequency of nausea, frequency of hypoglycemia, HbA1c reduction, and weight reduction. Attributes and levels were based on head-to-head clinical trial data of tirzepatide 5mg, 10mg, and 15mg versus semaglutide 1mg. Preference data were analyzed separately by country using multinomial mixed logit (MXL) models. MXL parameters were used to estimate the predicted preference for each tirzepatide dose versus semaglutide 1mg. Direct preferences for each dose of tirzepatide versus semaglutide 1mg were elicited. Results: Participants (N=620) in the US (N=301) and UK (N=319) were 50.8% and 50.5% female with mean ages of 60.7 years and 58.9 years, respectively. The order and magnitude of relative attribute importance (RAI) scores differed between countries. HbA1c reduction (26.3%) had the greatest impact on US participants' preferences, and hypoglycemia (32.8%) did among UK participants. Attribute-level marginal utility results indicated preferences for greater HbA1c improvements, the single-use pre-filled pen, lower hypoglycemia, greater weight reductions, and lower frequency of nausea. Assuming the availability of only tirzepatide or semaglutide 1mg, the predicted preference for tirzepatide (5, 10, and 15mg) in the US is 95.6% (vs 4.4% for semaglutide 1mg) and in the UK was 86.3% (vs 13.7% for semaglutide 1mg). Conclusion: HbA1c reduction, frequency of hypoglycemia, and weight reduction are key drivers of preferences among people with T2D when considering medication options. Overall, people with T2D are likely to prefer the tirzepatide over the semaglutide 1mg medication profiles.

People With Diabetes and Caregivers Prefer Rescue Glucagon Treatment With a Wider Storage Temperature Range and a Nasal Administration, When Efficacy is Similar: A Discrete Choice Experiment in Spain.

BACKGROUND: Conventional injectable glucagon (IG) and nasal glucagon (NG), both having similar efficacy, are two options for the emergency treatment of severe hypoglycemia in Spain. This study elicited the effect of changes in key attributes on preferences for NG and IG medication profiles of people with diabetes and caregivers in Spain. METHODS: The relative attribute importance (RAI) that participants placed on glucagon preparation, preparation and administration time, delivery method, recovery time, device size, storage temperature, and headache risk was estimated from an online discrete choice experiment. In addition, patients and caregivers were presented with NG and IG profiles that included rates of successful administration; the proportion of participants choosing each profile was summarized. RESULTS: The analysis included 276 adults with diabetes (65% type 1) and 270 caregivers (49% type 1). Overall mean age was 40 years; 51% were female. The most important attributes were storage temperature (RAI [95% confidence interval] = 27.3% [22.9-32.2]) and delivery method (17.4% [13.1-21.9]). Headache risk (16.2% [11.8-20.7]), time to prepare and administer (14.5% [10.1-18.8]), glucagon preparation (11.4% [6.8-15.8]), recovery time (8.9% [4.3-13.3]), and device size (4.3% [0.3-8.8]) were also relevant. When comparing medication profiles, significantly more participants (78%) preferred NG over IG profiles (P < .001). CONCLUSION: Adults with diabetes and caregivers prefer a glucagon treatment with a higher rate of successful administration, wider storage temperature, and nasal delivery method, when efficacy is similar. Participants favored NG over conventional IG as a rescue medication for severe hypoglycemia. This information may help decision-making by payers and treatment discussions between health care professionals and patients.

Cost of Severe Hypoglycemia and Budget Impact with Nasal Glucagon in Patients with Diabetes in Spain.

INTRODUCTION: Severe hypoglycemic events (SHE) represent a clinical and economic burden in patients with diabetes. Nasal glucagon (NG) is a novel treatment for SHEs with similar efficacy, but with a usability advantage over injectable glucagon (IG) that may translate to improved economic outcomes. The economic implications of this usability advantage on SHE-related spending in Spain were explored in this analysis. METHODS: A cost-offset and budget impact analysis (BIA) was conducted using a decision tree model, adapted for the Spanish setting. The model calculated average costs per SHE over the SHE treatment pathway following a treatment attempt with IG or NG. Analyses were performed separately in three populations with insulin-treated diabetes: children and adolescents (4-17 years) with type 1 diabetes (T1D), adults with T1D and adults with type 2 diabetes (T2D), with respective population estimates applied in BIA. Treatment probabilities were assumed to be equal for IG and NG, except for treatment success following glucagon administration. Epidemiologic and cost data were obtained from Spanish-specific sources. BIA results were presented at a 3-year time horizon. RESULTS: On a per SHE level, NG was associated with lower costs compared to IG (children and adolescents with T1D, EUR 820; adults with T1D, EUR 804; adults with T2D, EUR 725). Lower costs were attributed to reduced costs of professional medical assistance in patients treated with NG. After 3 years, BIA showed that relative to IG, the introduction of NG was projected to reduce SHE-related spending by EUR 1,158,969, EUR 142,162,371, and EUR 6,542,585 in children and adolescents with T1D, adults with T1D, and adults with insulin-treated T2D, respectively. CONCLUSIONS: In Spain, the usability advantage of NG over IG translates to potential cost savings per SHE in three populations with insulin-treated diabetes, and the introduction of NG was associated with a lower budget impact versus IG in each group.

The PRIME Type 2 Diabetes Model: a novel, patient-level model for estimating long-term clinical and cost outcomes in patients with type 2 diabetes mellitus.

BACKGROUND AND AIMS: The growing burden of diabetes mellitus and recent progress in understanding cardiovascular outcomes for type 2 diabetes (T2D) patients continue to make the disease a priority for healthcare decision-makers around the world. Our objective was to develop a new, product-independent model capable of projecting long-term clinical and cost outcomes for populations with T2D to support health economic evaluation. METHODS: Following a systematic literature review to identify longitudinal study data, existing T2D models and risk formulae for T2D populations, a model was developed (the PRIME Type 2 Diabetes Model [PRIME T2D Model]) in line with good practice guidelines to simulate disease progression, diabetes-related complications and mortality. The model runs as a patient-level simulation and is capable of simulating treatment algorithms and risk factor progression, and projecting the cumulative incidence of macrovascular and microvascular complications as well as hypoglycemic events. The PRIME T2D Model can report clinical outcomes, quality-adjusted life expectancy, direct and indirect costs, along with standard measures of cost-effectiveness and is capable of probabilistic sensitivity analysis. Several approaches novel to T2D modeling were utilized, such as combining risk formulae using a weighted model averaging approach that takes into account patient characteristics to evaluate complication risk. RESULTS: Validation analyses comparing modeled outcomes with published studies demonstrated that the PRIME T2D Model projects long-term patient outcomes consistent with those reported for a number of long-term studies, including cardiovascular outcomes trials. All root mean squared deviation (RMSD) values for internal validations (against published studies used to develop the model) were 1.1% or less and all external validation RMSDs were 3.7% or less. CONCLUSIONS: The PRIME T2D Model is a product-independent analysis tool that is available online and offers new approaches to long-standing challenges in diabetes modeling and may become a useful tool for informing healthcare policy.HIGHLIGHTSThe PRIME Type 2 Diabetes (T2D) Model is a new, product-independent simulation model.The model offers new approaches to long-standing challenges in diabetes modeling.PRIME T2D Model projects outcomes consistent with those from clinical trials.The model is designed to be a useful tool for informing healthcare policy in T2D.

Evaluation of the cost and medical resource use outcomes associated with nasal glucagon versus injectable glucagon for treatment of severe hypoglycemia in people with diabetes in Canada: a modeling analysis.

OBJECTIVES: Treatments for severe hypoglycemia aim to restore blood glucose through successful administration of rescue therapy, and choosing the most effective and cost-effective option will improve outcomes for patients and may reduce costs for healthcare payers. The present analysis aimed to compare costs and use of medical services with nasal glucagon and injectable glucagon in people with type 1 and 2 diabetes in Canada when used to treat severe hypoglycemic events when impaired consciousness precludes treatment with oral carbohydrates using an economic model, based on differences in the frequency of successful administration of the two interventions. METHODS: A decision tree model was prepared in Microsoft Excel to project outcomes with nasal glucagon and injectable glucagon. The model structure reflected real-world decision-making and treatment outcomes, based on Canada-specific sources. The model captured the use of glucagon, emergency medical services (EMS), emergency room, inpatient stay, and follow-up care. Costs were accounted for in 2019 Canadian dollars (CAD). RESULTS: Nasal glucagon was associated with reduced use of all medical services compared with injectable glucagon. EMS call outs were projected to be reduced by 45%, emergency room treatments by 52%, and inpatient stays by 13%. Use of nasal glucagon was associated with reduced direct, indirect, and combined costs of CAD 1,249, CAD 460, and CAD 1,709 per severe hypoglycemic event, respectively, due to avoided EMS call outs and hospital costs, resulting from a higher proportion of successful administrations. CONCLUSIONS: When a patient with type 1 or type 2 diabetes is being treated for a severe hypoglycemic event when impaired consciousness precludes treatment with oral carbohydrate, use of nasal glucagon was projected to be dominant versus injectable glucagon in Canada reducing costs and use of medical services.

Conversations and reactions around severe hypoglycemia (CRASH) global survey of people with type 1 diabetes or insulin-treated type 2 diabetes and caregivers: Findings from the French cohort.

AIM: The objective of the CRASH (Conversations and Reactions Around Severe Hypoglycemia) survey was to further our understanding of the characteristics, experience, behavior and conversations with healthcare professionals (HCPs) of people with diabetes (PWD) receiving insulin, and of caregivers (CGs) caring for such people, concerning hypoglycemia requiring external assistance (severe hypoglycemic events [SHEs]). METHODS: CRASH was an online cross-sectional survey conducted across eight countries. PWD with self-reported type 1 (T1D) or insulin-treated type 2 (T2D) diabetes were aged≥18 years and had experienced one or more SHEs in the past 3 years; CGs were non-medical professionals aged ≥18 years, caring for PWD meeting all the above criteria except for PWD age (≥4 rather than ≥18 years). The present report is a descriptive analysis of data from France. RESULTS: Among PWD who had ever discussed SHEs with an HCP, 38.9% of T1D PWD and 50.0% of T2D PWD reported that SHEs were discussed at every consultation; 26.3% and 8.8%, respectively, had not discussed the most recent SHE with an HCP. In total, 35.7% of T1D PWD and 53.8% of T2D PWD reported that glucagon was not available to them at the time of their most recent SHE. Only 16.9% of T1D PWD and 6.5% of T2D PWD who had discussed their most recent SHE with an HCP reported that the HCP recommended obtaining a glucagon kit or asked them to confirm that they already had one. High proportions of PWD and CGs reported that the most recent SHE had made them feel unprepared, scared and helpless and had affected mood, emotional state and activities. CONCLUSION: CRASH survey data from France identify a need for greater discussion about SHEs between HCPs and PWD and the CGs of such people, and reveal gaps in the diabetes education of PWDs and CGs.

Cost of post-deployment screening for mental illness in the UK military: findings from a cluster randomised controlled trial.

BACKGROUND: Little is known about the economic impact of military mental health screening. AIMS: To investigate (a) whether post-deployment screening of military personnel affects use and cost of services and (b) the impact of psychiatric morbidity on costs. METHODS: Participants were recruited from UK Royal Marine and Army platoons and randomised to an intervention group (which received tailored advice predicated upon mental health status) or a control group (which received general advice following assessment of mental health status). The intervention costs were calculated while service use and associated costs were assessed at 12-month follow-up. RESULTS: Data were available for 6323 participants. Mean screening cost was £34. Service costs were slightly higher in the control group compared to the intervention group (£1197 vs. £1147) which was not statistically significant (bootstrapped 95%CI, -£363 to £434. In both groups, screening and control, costs were significantly higher for those who screened positive for mental health problems. CONCLUSIONS: Costs were not affected by screening. In countries that have already implemented post-deployment screening, the political cost of disinvestment needs careful consideration. Those who develop psychiatric morbidity have substantially higher care costs than those who do not.

Conversations and Reactions Around Severe Hypoglycaemia (CRASH): Results from the German Cohort of a Global Survey of People with Type 1 Diabetes or Insulin-Treated Type 2 Diabetes and Caregivers.

BACKGROUND: A global cross-sectional survey (CRASH) was designed to provide information about the experiences of people with diabetes (PWD) and their caregivers in relation to severe hypoglycaemic events. METHODS: Adults with type 1 diabetes or insulin-treated type 2 diabetes who had experienced one or more severe hypoglycaemic events within the past 3 years, and adult caregivers for such people, were recruited from medical research panels using purposive sampling. We present here results from Germany. RESULTS: Approximately 100 individuals in each of the four participant groups completed a 30-minute online survey. Survey results indicated that the most recent severe hypoglycaemic event made many participants feel scared (80.4%), unprepared (70.4%), and/or helpless (66.5%). Severe hypoglycaemia was discussed by healthcare professionals at every visit with only 20.2% of participants who had ever had this conversation, and 53.5% of participants indicated that their insulin regimen had not changed following their most recent event. 37.1% of PWD/people with diabetes cared for by caregivers owned a glucagon kit at the time of survey completion. CONCLUSIONS: The survey identified areas for improvement in the prevention and management of severe hypoglycaemic events. For healthcare professionals, these include enquiring more frequently about severe hypoglycaemia and adjusting blood glucose-lowering medication after a severe hypoglycaemic event. For individuals with diabetes and their caregivers, potential improvements include ensuring availability of glucagon at all times. Changes in these areas could lead not only to improved patient wellbeing but also to reduced use of emergency services/hospitalisation and, consequently, lower healthcare costs.

Conversations and Reactions Around Severe Hypoglycaemia (CRASH): Spanish results of a global survey of people with type 1 diabetes or insulin-treated type 2 diabetes and caregivers.

INTRODUCTION: Information on experience/management of severe hypoglycaemic events (SHEs) among people with insulin-treated diabetes (PWD) and caregivers (CGs) providing care to PWD was sought. MATERIALS AND METHODS: An online cross-sectional survey was conducted in eight countries. INCLUSION CRITERIA: PWD (aged≥18 years; self-reported type 1 [T1D] or insulin-treated type 2 [T2D] diabetes; experienced ≥1 SHE [hypoglycaemia requiring external assistance] in past 3 years); CGs (layperson aged ≥18 years; caring for PWD meeting all criteria above except age [≥4 years]). This descriptive analysis provides data from Spain. SHE-associated data relate to the most recent SHE. RESULTS: Across all groups (T1D PWD, n=106; T2D PWD, n=88, T1D CG, n=87; T2D CG, n=96), 76-89% reported that the SHE occurred at home; most common cause was eating less than planned (38-53%). Most usual action during the SHE was to intake carbohydrates (67-84%); glucagon use was low (9-36%). Discussion of the SHE with their healthcare provider (HCP) was reported by 70-75% of PWD. During the SHE, 35-69% of PWD/CGs reported feeling scared, unprepared and/or helpless. CONCLUSIONS: Most SHEs occurred outside the healthcare setting; treatment therefore depends greatly on CGs. SHEs have a negative emotional impact on PWD/CGs, underscoring the need for HCPs to discuss SHEs with PWD/CGs, and to provide tools and strategies to prevent and effectively manage SHEs.

Satisfaction, Preference and Injection Habits of Switching to 200 Units/ml Insulin Lispro Pen from 100 Units/ml: A Patient Survey in Germany.

INTRODUCTION: The study was designed to assess patient satisfaction, preferences and injection habits for patients using insulin lispro 200 units/ml pen (IL200) compared to their previously used disposable 100 units/ml mealtime insulin pen ("MTI-100 pen") in Germany. METHODS: A site-based, cross-sectional study involving a self-reported survey and medical record extraction in patients with diabetes currently using IL200 for between 3 and 12 months and had previously used any disposable MTI-100 pen. RESULTS: Of 114 patients included, 83.3% were satisfied with IL200 and 3.5% were dissatisfied; 70.2% preferred IL200 over their previous MTI-100 pen and 4.4% preferred their previous MTI-100 pen. The main reasons for IL200 preference were the amount of insulin the pen carries, longer use before discarding, number of non-empty pens discarded, injection volume and frequency replacing pens. Patients discarded (median) 4 IL200 pens per month with 5.3% discarding more than 10 units in their last pen. When insufficient insulin remained to complete a dose, 74.6% injected the remainder and completed with a new pen, 19.3% discarded the pen with remaining insulin, 7.0% saved it for future use and 1.8% left the dose incomplete. CONCLUSIONS: Satisfaction and preference for IL200 was high in this sample of patients using IL200 for 3-12 months. Reasons were consistent with IL200 features, explaining the better patient experience and potential resource saving transitioning from a disposable MTI-100 pen.

An assessment of physician reasons for prescribing Insulin Lispro 200 units/ml in Germany.

OBJECTIVE: To understand physicians' reasons for prescribing Insulin Lispro 200 units/ml (IL200) and their experience with IL200 treatment in Germany. METHODS: The survey consisted of 28 questions on physician's profile, average IL200 patients' characteristics and rationales for prescribing IL200. Questions were rated on a scale of 0 ('not at all important'/'strongly disagree') to 4 ('absolutely important'/'strongly agree'). RESULTS: The surveyed physicians had a mean (SD) experience of 18.1 (7.0) years managing diabetes, consulted an average of 226.8 patients with diabetes/month and prescribed IL200 to 56.1% of their patients on mealtime insulin (MTI). About 80.0% of IL200 patients had type 2 diabetes mellitus, were overweight/obese, and received >20 units/day of MTI. More than 70.0% of physicians rated patient's insulin dose, pattern of self-measured glucose levels, hemoglobin A1c (HbA1c) (clinical); adherence, hypoglycemia knowledge, motivation to improve lifestyle, desire to reduce injection volume and emotional struggle with controlling HbA1c (behavioral) as 'very important'/'absolutely important' factors when prescribing IL200. CONCLUSION: Physicians considered IL200 a promising treatment option that reduces the injection burden for patients on MTI. Physicians adopted a patient-centered perspective by aligning IL200 prescribing decisions with each patient's medical needs and non-clinical preferences, with an aim to encourage treatment adherence through resorting to IL200's advantageous attributes.

Do welfare benefit reassessments of people with mental health conditions lead to worse mental health? A prospective cohort study.

BACKGROUND: There have been cases of suicide following the Work Capability Assessment (WCA), a questionnaire and interview for those claiming benefits due to ill health or disability in the United Kingdom. AIMS: To examine whether experiencing problems with welfare benefits, including WCA, among people with pre-existing mental health conditions was associated with poorer mental health and wellbeing and increased health service use and costs. METHODS: A prospective cohort study of an exposed group (n = 42) currently seeking help from a Benefits Advice Service in London and a control group (n = 45) who had recently received advice from the same service. Questionnaires at baseline and 3-, 6- and 12-month follow-ups. RESULTS: The exposed group had higher mean scores for anxiety (p = .008) and depression (p = .016) at baseline and the control group higher mean scores for wellbeing at baseline (p = .034) and 12 months (p = .035). However, loss to follow-up makes overall results difficult to interpret. The control group had higher incomes throughout the study, particularly at the 12-month follow-up (p = .004), but the differences could have been accounted for by other factors. Health service costs were skewed by a few participants who used day-care services intensively or had inpatient stays. Over the study period the proportion of exposed participants engaged in benefits reassessment ranged from 50% to 88%, and 40% to 76% of controls. CONCLUSION: The hardship of living with financial insecurity and a mental health condition made it difficult for our participants to sustain involvement in a 12-month study and the frequency of benefit reviews meant that the experiences of our controls were similar to our exposed group. These limitations limit interpretation but confirm the relevance of our research. The control data raise the question of whether people with mental health conditions are being disproportionately reassessed.

Patient Preferences and Health State Utilities Associated with Mealtime Insulin Concentrations Among Patients with Diabetes in Italy.

INTRODUCTION: Standard concentration (100 units/mL) mealtime insulin is frequently used to treat patients with type 1 (T1D) and type 2 diabetes (T2D). A more concentrated version of the medication (200 units/mL) has been available in Italy since 2016. This concentrated version is bioequivalent to the standard version and delivers the same amount of medication but in half the volume of liquid. The purpose of this study was to examine patient preferences and estimate health state utilities associated with standard and concentrated rapid-acting mealtime analog insulin. METHODS: Participants with T1D and T2D in Italy valued two health states in time trade-off interviews. The descriptions of diabetes and treatment in the two health states were identical, differing only in terms of insulin concentration (e.g., half as much liquid for the same dose, less effort needed to press the injection button, and fewer injection pens required with concentrated insulin). To ensure participants understood the health states, they were shown a short video illustrating the differences between concentrations. RESULTS: A total of 217 participants completed the interviews (49.8% male; mean age 56.1 years; 109 from Milan; 108 from Rome; 12.0% T1D; 88.0% T2D). When asked which health state they preferred, 98.2% responded the concentrated version, 0.9% said the standard version, and 0.9% had no preference. Mean [standard deviation (SD)] utilities rounded to three decimals were 0.892 (0.099) for the concentrated version and 0.884 (0.101) for the standard version. The mean (SD; p value) utility difference between the standard and concentrated rapid-acting insulin was 0.007 (0.019; p < 0.0001). CONCLUSIONS: Findings from this study provide insight into patient preferences associated with concentration of rapid-acting insulin. Although the difference in utility is small, patients consistently preferred the concentrated formulation over the standard insulin, and for some patients this difference had an impact on utility valuations. These results suggest that the concentration of rapid-acting insulin should be considered because it could affect treatment preference and quality of life. FUNDING: Eli Lilly and Company.

Nasal Glucagon Versus Injectable Glucagon for Severe Hypoglycemia: A Cost-Offset and Budget Impact Analysis.

BACKGROUND: Severe hypoglycemic events (SHEs) in patients with diabetes are associated with substantial health care costs in the United States (US). Injectable glucagon (IG) is currently available for treatment of severe hypoglycemia but is associated with frequent handling errors. Nasal glucagon (NG) is a novel, easier-to-use treatment that is more often administered successfully. The economic impact of this usability advantage was explored in cost-offset and budget impact analyses for the US setting. METHODS: A health economic model was developed to estimate mean costs per SHE for which treatment was attempted using NG or IG, which differed only in the probability of treatment success, based on a published usability study. The budget impact of NG was projected over 2 years for patients with type 1 diabetes (T1D) and type 2 diabetes treated with basal-bolus insulin (T2D-BB). Epidemiologic and cost data were sourced from the literature and/or fee schedules. RESULTS: Mean costs were $992 lower if NG was used compared with IG per SHE for which a user attempted treatment. NG was estimated to reduce SHE-related spending by $1.1 million and $230 000 over 2 years in 10 000 patients each with T1D and T2D-BB, respectively. Reduced spending resulted from reduced professional emergency services utilization as successful treatment was more likely with NG. CONCLUSIONS: The usability advantage of NG over IG was projected to reduce SHE-related treatment costs in the US setting. NG has the potential to improve hypoglycemia emergency care and reduce SHE-related treatment costs.

The Economic Cost of Patients With Migraine Headache Referred to Specialist Clinics.

OBJECTIVE: To conduct a cost of illness study to estimate the economic impact of referring people with headache to specialists. BACKGROUND: Headache is one of the commonest health conditions affecting individuals in society. METHODS: Participants formed a convenience sample and were recruited from specialist headache clinics across London. Self-report data on service use over a 4-month period and lost employment were provided. These data were used to estimate economic costs. Predictors of cost were identified using multivariate analyses. RESULTS: The mean (standard deviation) service costs for the 4-month period was £857 (£845). The mean total cost (including lost employment) was £6588 (£11,982) with costs of informal care accounting for 74% of this figure. Total costs were on average £1079 higher for a unit increase on the headache impact test scale (P < .001; 95% CI £330 to £1784). CONCLUSIONS: Costs of headache are high, and increase with severity of symptoms. The annual cost to the country for those referred to specialists is estimated at £835 million.

Efficacy of brief personcentered cognitive behavioral therapy to facilitate self-management for patients with Rheumatoid Arthritis: A mixed methods case series feasibility study / Eficacia de la terapia cognitivo conductual breve centrada en la persona para facilitar la autogestión de pacientes con artritis reumatoide: un estudio de la viabilidad de métodos mixtos para una serie de casos

The psychological consequences of living with rheumatoid arthritis (RA) are common. The objectives of this study were: (I) to investigate views of patients with RA about the provision of psychological support; (II) to study the efficacy of a person-centred cognitive behavioural therapy (CBT) self-management approach, including a health economic investigation. A mixed methods was applied: a formative qualitative interview study and a quantitative CBT intervention formed the case series feasibility study design, and a health economic investigation. The qualitative study highlighted that patients welcome emotional support. The CBT intervention from a small sample suggested that participants may have benefitted from the intervention until to the point of the follow-up. The results of the economic component need to be interpreted with caution in relation to service gaps. A broad approach in the delivery of a psychological intervention may benefit patients with long-term conditions. The practice implications are that RA patients may benefit from psychological interventions to cope better with their condition through personal intervention, and flexible appointment system. Intervention studies need to test this question in detail in the future

Las consecuencias psicológicas de vivir con artritis reumatoide (AR) son frecuentes. Los objetivos de este estudio fueron: (I) investigar las opiniones de los pacientes con AR acerca de la provisión de apoyo psicológico, (II) estudiar la eficacia de un enfoque de autogestión basado en la terapia cognitivo conductual (TCC) centrada en la persona, incluyendo una investigación económica de la salud. Se utilizaron métodos mixtos. Un estudio formativo de entrevista cualitativa y una intervención cuantitativa de TCC formaron el diseño del estudio de viabilidad de la serie de casos y una investigación económica de la salud. El estudio cualitativo destacó que los pacientes agradecen el apoyo emocional. La intervención de TCC con una pequeña muestra sugirió que los participantes podrían haberse beneficiado de la intervención hasta el seguimiento. Los resultados del componente económico deben interpretarse con precaución respecto a las carencias de los servicios. Un enfoque amplio en la prestación de una intervención psicológica puede beneficiar a los pacientes con dolencias a largo plazo. Las implicaciones prácticas son que los pacientes con AR pueden beneficiarse de intervenciones psicológicas para afrontar de mejor manera su enfermedad a través de una intervención personal y un sistema flexible de citas. Los estudios de intervención necesitan comprobar con detalle esta cuestión en el futuro

Reducing outcome measures in mental health: a systematic review of the methods.

BACKGROUND: Traditionally, classical test theory (CTT) has been used for instrument development and various methods have since been proposed for reducing outcome measures to shorter versions. These reduction methods have not previously been compared in mental or physical health. AIM: To identify and compare the various methods used to develop brief versions of outcome measures from existing measures in mental health. METHOD: A systematic review of the literature in Embase, Medline, PsychInfo and from a grey literature was done. Search strategies were developed in each database to identify all relevant literature based on the inclusion criteria. Each paper identified was briefly described and then assessed using a bespoke assessment checklist developed by the authors. Methods for reducing outcome measures found across all studies were compared. RESULTS: Ten papers were identified. Five methods were used for scale reduction: Rasch analysis (RA), exploratory factor analysis (EFA), graded response models (GRMs), all-subset regression, and regression. RA was the most widely used process. CONCLUSION: The Rasch model (RM) is the only model where "'specific objectivity"' is a defining property of the model. This property is necessary for constructing scales in line with the fundamental principles of measurement.