Assessing patient PREFERence between the dulaglutide pen and the semaglutide pen: A crossover study (PREFER).

AIM: When selecting treatments for type 2 diabetes (T2D), it is important to consider not only efficacy and safety, but also other treatment attributes that have an impact on patient preference. The objective of this study was to examine preference between injection devices used for two weekly GLP-1 receptor agonists. MATERIALS AND METHODS: The PREFER study was an open-label, multicentre, randomized, crossover study assessing patient preference for dulaglutide and semaglutide injection devices among injection-naïve patients receiving oral medication for type 2 diabetes. After being trained to use each device, participants performed all steps of injection preparation and administered mock injections into an injection pad. Time-to-train (TTT) for each device was assessed in a subset. RESULTS: There were 310 evaluable participants (48.4% female; mean age, 60.0 years; 78 participants in the TTT subgroup). More participants preferred the dulaglutide device than the semaglutide device (84.2% vs. 12.3%; P < 0.0001). More participants perceived the dulaglutide device to have greater ease of use (86.8% vs. 6.8%; P < 0.0001). After preparing and using the devices, more participants were willing to use the dulaglutide device (93.5%) than the semaglutide device (45.8%). Training participants to use the dulaglutide device required less time than the semaglutide device (3.38 vs. 8.14 minutes; P < 0.0001). CONCLUSIONS: Participants with type 2 diabetes preferred the dulaglutide injection device to the semaglutide injection device. If patients prefer a device, they may be more willing to use the medication, which could result in better health outcomes. Furthermore, a shorter training time for injection devices may be helpful in busy clinical practice settings.

Acute and chronic impact of cardiovascular events on health state utilities.

BACKGROUND: Cost-utility models are frequently used to compare treatments intended to prevent or delay the onset of cardiovascular events. Most published utilities represent post-event health states without incorporating the disutility of the event or reporting the time between the event and utility assessment. Therefore, this study estimated health state utilities representing cardiovascular conditions while distinguishing between acute impact including the cardiovascular event and the chronic post-event impact. METHODS: Health states were drafted and refined based on literature review, clinician interviews, and a pilot study. Three cardiovascular conditions were described: stroke, acute coronary syndrome (ACS), and heart failure. One-year acute health states represented the event and its immediate impact, and post-event health states represented chronic impact. UK general population respondents valued the health states in time trade-off tasks with time horizons of one year for acute states and ten years for chronic states. RESULTS: A total of 200 participants completed interviews (55% female; mean age = 46.6 y). Among acute health states, stroke had the lowest utility (0.33), followed by heart failure (0.60) and ACS (0.67). Utility scores for chronic health states followed the same pattern: stroke (0.52), heart failure (0.57), and ACS (0.82). For stroke and ACS, acute utilities were significantly lower than chronic post-event utilities (difference = 0.20 and 0.15, respectively; both p < 0.0001). CONCLUSIONS: Results add to previously published utilities for cardiovascular events by distinguishing between chronic post-event health states and acute health states that include the event and its immediate impact. Findings suggest that acute versus chronic impact should be considered when selecting scores for use in cost-utility models. Thus, the current utilities provide a unique option that may be used to represent the acute and chronic impact of cardiovascular conditions in economic models comparing treatments that may delay or prevent the onset of cardiovascular events.

Impact of caregiver and parenting status on time trade-off and standard gamble utility scores for health state descriptions.

BACKGROUND: The purpose of this study was to examine the effect of caregiver status on time trade-off (TTO) and standard gamble (SG) health state utility scores. Respondents were categorized as caregivers if they reported that either children or adults depended on them for care. METHODS: This study was a secondary analysis of data from three studies in which general population samples rated health state descriptions. Study 1: UK; four osteoarthritis health states. Study 2: UK; three adult ADHD health states. Study 3: US; 16 schizophrenia health states. All three studies included time trade-off assessment. Study 1 also included standard gamble. Descriptive statistics were calculated to examine willingness to trade in TTO or gamble in SG. Utilities for caregivers and non-caregivers were compared using t-tests and ANCOVA models. RESULTS: There were 364 respondents including 106 caregivers (n = 30, 47, and 29 in Studies 1, 2, and 3) and 258 non-caregivers. Most caregivers were parents of dependent children (78.3%). Compared to non-caregivers, caregivers had more responses at the ceiling (i.e., utility = 0.95), indicating less willingness to trade time or gamble. All utilities were higher for caregivers than non-caregivers (mean utility difference between groups: 0.07 to 0.16 in Study 1 TTO; 0.03 to 0.17 in Study 1 SG; 0.06 to 0.10 in Study 2 TTO; 0.11 to 0.22 in Study 3 TTO). These differences were statistically significant for at least two health states in each study (p < 0.05). Results of sensitivity analyses with two caregiver subgroups (parents of dependent children and parents of any child regardless of whether the child was still dependent) followed the same pattern as results of the primary analysis. The parent subgroups were generally less willing to trade time or gamble (i.e., resulting in higher utility scores) than comparison groups of non-parents. CONCLUSIONS: Results indicate that caregiver status, including being a parent, influences responses in time trade-off health state valuation. Caregivers (i.e., predominantly parents) were less willing than non-caregivers to trade time, resulting in higher utility scores. This pattern was consistent across multiple health states in three studies. Standard gamble results followed similar patterns, but with less consistent differences between groups. It may be useful to consider parenting/caregiving status when collecting, interpreting, or using utility data because this demographic variable could influence results.

Physician Perceptions of Dose Escalation for Type 2 Diabetes Medications in the United States.

INTRODUCTION: Medications used to treat type 2 diabetes (T2D) often require dose escalation to optimize effectiveness. Physician and patient perceptions of treatment characteristics of T2D medications have previously been examined, but little is known about perceptions of escalation to the optimal dose for each patient. This study examined physicians' perceptions of dose escalation for medications used to treat T2D. METHODS: Data on dose escalation and other factors influencing decision-making for treatment of T2D were collected via an online survey of endocrinologists and primary care physicians in the USA. RESULTS: The sample included 501 physicians (348 primary care physicians and 153 endocrinologists). Dose escalation was not frequently considered by physicians as a primary factor keeping patients' from reaching treatment goals (mentioned as a factor by only 7.6% of the sample) or a barrier to prescribing T2D medication (16.2%). Factors more likely to keep patients from reaching treatment goals included an unhealthy diet (86.6%) and medication adherence (77.4%). The most common reasons that physicians reported for escalating dose levels were the need for better glycemic control (reported by 89.8% of the sample), ability to decrease the total number of medications by increasing the dose of one medication (39.9%), and the need for the patient to lose weight (39.3%). Data reported by primary care physicians and endocrinologists followed similar patterns. CONCLUSIONS: Although common with T2D treatments, escalating the dose of T2D medication was not perceived by physicians to be a significant barrier to attaining treatment goals or prescribing medication. Multiple factors contribute to the decision to escalate the dose of T2D medication.

In early phases of initiating medication treatment for a patient with type 2 diabetes (T2D), it is common for physicians to increase from a lower initial dose to a higher end dose to maximize treatment benefit. This process is known as dose escalation. The purpose of this study was to examine physicians' perceptions of dose escalation for medications used to treat T2D. An online survey was designed to identify reasons why physicians in the US may choose to escalate or not escalate a dose of medication for T2D. In addition, physicians were asked about factors that keep patients from reaching treatment goals to identify whether the requirement for dose escalation is perceived to be a common barrier to successful treatment. The sample included 501 physicians (348 primary care, 153 endocrinologists). Dose escalation was not frequently considered to be a primary factor keeping patients' from reaching treatment goals or a barrier to prescribing medication for T2D. Dose escalation decisions are complex, driven by a range of factors such as glycemic control medication tolerability, the patient's body mass index, treatment guidelines, comorbidities, characteristics of the patient's entire treatment regimen, and potential cardiovascular benefits.

Patient Perceptions of and Preferences Between Characteristics of Injectable Diabetes Treatments.

INTRODUCTION: The administration of medications targeting type 2 diabetes mellitus (T2D) has evolved over time. As injection delivery systems continue to evolve, it is necessary to understand patients' perceptions of currently available treatments. The objective of this study was to examine the patient perspective of injectable treatment for T2D and identify characteristics of these treatments that are most important to patients. METHODS: Data were collected via an online survey study with a sample of individuals in the UK and US who were treated for T2D with injectable medication. The survey was designed to elicit perceptions of the treatment process for injectable glucagon-like peptide 1 (GLP-1) receptor agonists and insulin. RESULTS: The sample included 504 participants (251 UK, 253 US). Approximately half (50.4%) were treated with a GLP-1 receptor agonist and half (49.6%) were treated with insulin. Respondents were presented with a list of 17 characteristics of injectable medication and asked to indicate which were most important to them. Respondents most frequently selected confidence in administering the correct dose (n = 300, 59.5%); ease of selecting the correct dose (n = 268, 53.2%); overall ease of using the injection device (n = 239, 47.4%); frequency of injections (n = 223, 44.2%); and ease of carrying the device when necessary to inject away from home (n = 190, 37.7%). Characteristics least frequently cited as important included dose escalation (n = 79, 15.7%); handling the needle (n = 74, 14.7%); connectivity to an electronic device (n = 70, 13.9%); and the time required to prepare and inject each dose (n = 62, 12.3%). CONCLUSION: Results of this survey suggest that patients prioritize some attributes of injectable treatments over others. These findings may have implications for clinical practice and development of injection devices.

Resilience training for functioning adults: program description and preliminary findings from a pilot investigation.

It has previously been asserted that the construct of resilience holds great promise for diverse high-risk populations and that resilience may be an attribute that can be acquired through training. A rich body of literature suggests the strengths that comprise resilience. This paper describes a resilience training program based upon the identified strengths of resilience and provides additional preliminary data from a pilot investigation which lend support to the idea that resilience can be acquired through training. Suggestions for future research are provided.

Patient-Reported Outcomes and Impact of Type 2 Diabetes: A Cross-Sectional Study in the Kingdom of Saudi Arabia.

BACKGROUND: The Kingdom of Saudi Arabia (KSA) has the second highest prevalence of type 2 diabetes mellitus (T2DM) in the Middle East. There is a paucity of research on the experiences and treatment preferences of patients with T2DM in KSA. This study explored Saudi patients' health-related quality of life, eating habits, experiences during Ramadan, and preference between two glucagon-like peptide-1 receptor agonist (GLP-1 RA) treatment devices. METHODS: A cross-sectional, observational study was conducted in three cities in KSA. Participants completed sociodemographic and clinical forms, EQ-5D-5L, Impact of Weight on Self-Perceptions, and a diabetes treatment survey. Participants also viewed instructional videos on GLP-1 RA injection devices and indicated their device preference. RESULTS: Of the 310 participants, 53% were male. The mean age was 43 years (range: 30.0-75.0), duration since diabetes diagnosis was 6.3 years (range: 0.2-27.1), the most commonly reported last HbA1c level was between ≥7.1% and 8% (45%). The mean EQ-5D-5L index score was 0.90, with some participants reporting problems with pain/discomfort (34.5%) and usual activities (33.2%). Patients reported a low-to-moderate impact of weight on self-perception. In preparation for Ramadan, participants sought physician advice on diabetes management (37%) and/or increased checks of their blood glucose (37%). After watching the videos, 89% (n=277) of participants indicated a device preference, with significantly more preferring the dulaglutide device (n=186, 67%) over the semaglutide device (n=91, 33%) (p<0.0001). CONCLUSION: This study indicates that T2DM has a significant social, emotional, and behavioral impact on the lives of patients in KSA.

Patient preferences in Italy: health state utilities associated with attributes of weekly injection devices for treatment of type 2 diabetes.

OBJECTIVES: Several glucagon-like peptide-1 receptor agonists are administered as weekly injections for treatment of type 2 diabetes (T2D). These medications vary in their injection processes, and a recent study in the UK found that these differences had an impact on patient preference and health state utilities. The purpose of this study was to replicate the UK study in Italy to examine preferences of an Italian patient sample, while allowing for comparison between utilities in the UK and Italy. MATERIALS AND METHODS: Participants with T2D in Italy valued health states in time trade-off interviews. All health states had the same description of T2D, but differed in description of the treatment process. As in the original UK study, the first health state described an oral treatment regimen, while additional health states added a weekly injection. The injection health states differed in three injection-related attributes: requirements for reconstituting the medication, waiting during medication preparation, and needle handling. RESULTS: Interviews were completed by 238 patients (58.8% male; mean age = 60.2 years; 118 from Milan, 120 from Rome). The oral treatment health state had a mean (SD) utility of 0.90 (0.10). The injection health states had significantly (p < 0.0001) lower utilities, which ranged from 0.87 (requirements for reconstitution, waiting, and handling) to 0.89 (weekly injection with none of these requirements). Differences in health state utility scores suggest that each administration requirement was associated with a disutility (ie, negative utility difference): -0.006 (reconstitution), -0.006 (needle handling), -0.011 (reconstitution, needle handling), and -0.022 (reconstitution, waiting, needle handling). CONCLUSION: Disutilities associated with the injection device characteristics were similar to those reported with the UK sample. Results suggest that injection device attributes may be important to some patients with T2D, and it may be useful for clinicians to consider these attributes when choosing medication for patients initiating these weekly treatments.

Physician perceptions of GLP-1 receptor agonists in the UK.

Objectives Glucagon-like peptide-1 (GLP-1) receptor agonists have been used to treat type 2 diabetes for almost a decade, and new treatments in this class have recently been introduced. The purpose of this study was to examine perceptions of GLP-1 receptor agonists among physicians who treat patients with type 2 diabetes in the UK. Methods A total of 670 physicians (226 diabetes specialists; 444 general practice [GP] physicians) completed a survey in 2014. Results Almost all physicians had prescribed GLP-1 receptor agonists (95.4% total sample; 99.1% specialists; 93.5% GP), most frequently to patients whose glucose levels are not adequately controlled with oral medications (85.9% of physicians) and obese/overweight patients (83.7%). Physicians' most common reasons for prescribing a GLP-1 receptor agonist were: associated with weight loss (65.8%), good efficacy (55.7%), less hypoglycemia risk than insulin (55.2%), not associated with weight gain (34.5%), and better efficacy than oral medications (32.7%). Factors that most commonly cause hesitation when prescribing this class were: not considered first line therapy according to guidelines (56.9%), injectable administration (44.6%), cost (36.7%), gastrointestinal side effects (33.4%), and risk of pancreatitis (26.7%). Almost all specialists (99.1%) believed they had sufficient knowledge to prescribe a GLP-1 receptor agonist, compared with 76.1% of GPs. Conclusions Results highlight the widespread use of GLP-1 receptor agonists for treatment of type 2 diabetes in the UK. However, almost a quarter of GPs reported that they do not have enough knowledge to prescribe GLP-1s, suggesting a need for increased dissemination of information to targeted groups of physicians. Study limitations were that the generalizability of the clinician sample is unknown; survey questions required clinicians to select answers from multiple response options rather than generating the responses themselves; and responses to this survey conducted in 2014 do not reflect perceptions of the most recently introduced GLP-1 receptor agonists.

Health state utilities associated with attributes of treatments for hepatitis C.

BACKGROUND: Cost-utility analyses are frequently conducted to compare treatments for hepatitis C, which are often associated with complex regimens and serious adverse events. Thus, the purpose of this study was to estimate the utility associated with treatment administration and adverse events of hepatitis C treatments. DESIGN: Health states were drafted based on literature review and clinician interviews. General population participants in the UK valued the health states in time trade-off (TTO) interviews with 10- and 1-year time horizons. The 14 health states described hepatitis C with variations in treatment regimen and adverse events. RESULTS: A total of 182 participants completed interviews (50% female; mean age = 39.3 years). Utilities for health states describing treatment regimens without injections ranged from 0.80 (1 tablet) to 0.79 (7 tablets). Utilities for health states describing oral plus injectable regimens were 0.77 (7 tablets), 0.75 (12 tablets), and 0.71 (18 tablets). Addition of a weekly injection had a disutility of -0.02. A requirement to take medication with fatty food had a disutility of -0.04. Adverse events were associated with substantial disutilities: mild anemia, -0.12; severe anemia, -0.32; flu-like symptoms, -0.21; mild rash, -0.13; severe rash, -0.48; depression, -0.47. One-year TTO scores were similar to these 10-year values. CONCLUSIONS: Adverse events and greater treatment regimen complexity were associated with lower utility scores, suggesting a perceived decrease in quality of life beyond the impact of hepatitis C. The resulting utilities may be used in models estimating and comparing the value of treatments for hepatitis C.

Health state utilities associated with adult attention-deficit/hyperactivity disorder.

OBJECTIVES: With growing awareness of the importance of adult attention-deficit/hyperactivity disorder (ADHD) treatment, cost-effectiveness analyses, including utilities, are needed to compare the value of treatment options. Although utilities have been reported for childhood ADHD, little is known about utilities representing adult ADHD. Therefore, the purpose of this study was to estimate utilities associated with adult ADHD. METHODS: Health-state descriptions of adult ADHD were drafted based on literature review, interviews with four clinicians, and clinical trial data. Health states were revised based on a pilot study with 26 participants. Final health states were rated in time trade-off interviews with general population respondents in London and Edinburgh, UK. RESULTS: A total of 158 participants completed interviews (mean age =47.0 years; 49.4% female; Edinburgh =80 participants). Mean (standard deviation [SD]) utilities were 0.82 (0.17), 0.68 (0.28), and 0.67 (0.28) for health states describing treatment responders (health state A), nonresponders (health state B), and untreated patients (health state C), respectively. Most participants rated health state A as preferable to B (n=92; 58.2%) and C (n=97; 61.4%). The majority rated B and C as equal (n=125; 79.1%). Paired Student's t-tests found that A had a significantly greater mean utility than B (t=10.0; P<0.0001) and C (t=10.2; P<0.0001). CONCLUSION: The current study provides utilities that may be used in cost-utility models of treatment for adult ADHD. Results reflected clear differences between health states representing treatment responders and nonresponders/untreated patients. Current utilities were comparable to those previously reported for childhood ADHD.

Challenges to time trade-off utility assessment methods: when should you consider alternative approaches?

In recent years, the time trade-off (TTO) method, most commonly with a 10-year time horizon, has been the most frequently used approach for direct health state utility assessment, likely due to National Institute for Health and Care Excellence (NICE) preference for comparability with the EQ-5D, which has a utility scoring algorithm derived via this method. Although comparability to previous utility studies is important, there are situations when the TTO method may not be appropriate. The purpose of the current review is to highlight challenges to the TTO method. Five challenges to the TTO method are discussed: mild health states, small differences among health states, temporary health states, pediatric health states, and assessment of samples with particular characteristics. Some of these challenges are associated with the 10-year time horizon, while other situations may raise issues for TTO methods regardless of the time horizon. Alternative approaches for valuing health states are suggested.