Economic Burden of Itch-Related Sleep Loss in Moderate-to-Severe Atopic Dermatitis in the United Kingdom.

INTRODUCTION: Atopic dermatitis is associated with intense itch, which has been shown to cause sleep disruption that significantly impacts the lives of patients with atopic dermatitis. Despite this, little is known about its burden to the healthcare system and society. This study aimed to quantify the economic burden of itch-related sleep loss in moderate-to-severe atopic dermatitis in the UK. METHODS: A literature-based decision-analytic model was developed from a healthcare payer and societal perspective. The model quantifies the economic burden by linking the severity of itch to the number of days of sleep disruption. The model captures the direct costs of healthcare resource utilization and treatment alongside the indirect costs of productivity loss from absenteeism and presenteeism at work over a 5-year time horizon. The patient population considered was patients aged ≥ 15 years with moderate-to-severe atopic dermatitis and itch-related sleep disruption. RESULTS: The model estimated that itch-related sleep disruption as a result of moderate-to-severe atopic dermatitis would affect an average of 821,142 people over the time horizon (2022 to 2026). This translates into an average net economic burden of £3.8 billion (£4687 per patient), with an average of 172 million days being affected by sleep disruption per year in the UK. The greatest contributor to the annual average net economic burden was productivity loss from absenteeism and presenteeism, each accounting for 34%. The direct costs (treatment costs and healthcare resource use) accounted for 32% of the net economic burden. The results showed a high and gradually increasing economic burden over the 5-year time horizon. CONCLUSIONS: Sleep disruption has a high economic burden and reducing itch may provide substantial direct and indirect savings. Quantifying the economic burden of itch-related sleep loss may provide support for analyses to inform public health policies for treatment of atopic dermatitis, particularly within the moderate-to-severe level.

Economic impact analysis of a minimally invasive temperature-controlled radiofrequency device versus nasal surgery for the treatment of nasal airway obstruction in the United States.

OBJECTIVE: To determine the economic impact of a minimally invasive temperature-controlled radiofrequency (TCRF) device for treating nasal airway obstruction (NAO). METHODS: A budget impact model was developed for two scenarios: a reference scenario of functional rhinoplasty surgery with concomitant septoplasty and inferior turbinate reduction (ITR) performed in the hospital outpatient department where TCRF is not an available treatment option and a new scenario consisting of in-office TCRF treatment of the nasal valve and ITR. A payor perspective was adopted with a hypothetical population plan size of one million members. Costs were estimated over a time horizon of 4 years. The eligible population included patients with severe/extreme NAO and nasal valve collapse (NVC) as the primary cause or significant contributor. Data inputs were sourced from targeted literature reviews. Uncertainty within the model structure and input parameters was assessed using one-way sensitivity analysis. RESULTS: The introduction of a TCRF device resulted in population-level cost savings of $20,015,123 and per-responder average cost savings of $3531 through a 4-year time horizon due to lower procedure costs and complication rates of the device relative to the surgical comparator. Results were robust when varying parameter values in sensitivity analyses, with cost savings being most sensitive to the prevalence of NAO and estimated response rates to functional rhinoplasty and TCRF. CONCLUSIONS: In patients with severe/extreme NAO, with NVC as the primary or major contributor, introducing TCRF with ITR as a treatment option demonstrates the potential for significant cost savings over functional rhinoplasty with septoplasty and ITR.

Nasal valve dysfunction is a common cause of nasal airway obstruction (NAO) that has a significant impact on heath and quality of life for affected individuals. Previously, patients were offered temporary measures or a type of surgery called functional rhinoplasty which is a highly complex surgery that can be costly, requires recovery time, and in rare cases, not be successful. Recently, a new minimally invasive treatment alternative for NAO called temperature-controlled radiofrequency (TCRF) that may be performed in a surgery center or a doctor's office has become available. This paper provides the results of budget impact analysis performed to assess whether adding the TCRF procedure in place of surgery as a choice for patients with NAO will result in cost savings to an insurance payer with 1 million covered individuals in the United States over a period of 4 years. Results show that TCRF may result in an average of 9,416 fewer rhinoplasty surgeries, provide an average 4-year cost-savings of $3,531 for every patient that responds to TCRF treatment, and a savings of $20,015,123 over 4 years for the insurance provider. These potential cost savings over 4 years would likely be due to reduced procedure costs and complication rates compared to surgery.

Acceptability of Online Yoga Among Individuals With Chronic Conditions and Their Caregivers: Qualitative Study.

BACKGROUND: The online delivery of yoga interventions rapidly expanded during the COVID-19 pandemic, and preliminary studies indicate that online yoga is feasible across multiple chronic conditions. However, few yoga studies provide synchronous online yoga sessions and rarely target the caregiving dyad. Online chronic disease management interventions have been evaluated across conditions, life spans, and diverse samples. However, the perceived acceptability of online yoga, including self-reported satisfaction and online delivery preferences, is underexplored among individuals with chronic conditions and their caregivers. Understanding user preferences is essential for successful and safe online yoga implementation. OBJECTIVE: We aimed to qualitatively examine the perceived acceptability of online yoga among individuals with chronic conditions and their caregivers who participated in an online dyadic intervention that merged yoga and self-management education to develop skills (MY-Skills) to manage persistent pain. METHODS: We conducted a qualitative study among 9 dyads (>18 years of age; individuals experiencing persistent moderate pain) who participated in MY-Skills online during the COVID-19 pandemic. The intervention consisted of 16 online, synchronous yoga sessions over 8 weeks for both dyad members. After the completion of the intervention, participants (N=18) participated in semistructured telephone interviews for around 20 minutes, discussing their preferences, challenges, and recommendations for improved online delivery. Interviews were analyzed by using a rapid analytic approach. RESULTS: MY-Skills participants were, on average, aged 62.7 (SD 19) years; were primarily women; were primarily White; and had a mean of 5.5 (SD 3) chronic conditions. Both participants and caregivers reported moderate pain severity scores (mean 6.02, SD 1.3) on the Brief Pain Inventory. The following three themes were identified related to online delivery: (1) participants indicated a preference for the intervention to be in person rather than online because they were distracted in the home setting, because they felt that in-person yoga would be more engaging, because the yoga therapist could physically correct positions, and because of safety concerns (eg, fear of falling); (2) participants indicated good acceptability of online MY-Skills delivery due to convenience, access, and comfort with being in their home; and (3) recommendations for improving online delivery highlighted a need for additional and accessible technical support. CONCLUSIONS: Both individuals with chronic conditions and their caregivers find online yoga to be an acceptable intervention. Participants who preferred in-person yoga did so due to distractions in the home and group dynamics. Some participants preferred in-person corrections to ensure correct positioning, while others felt safe with verbal modifications in their homes. Convenience and access were the primary reasons for preferring online delivery. To improve online delivery, future yoga studies should include specific activities for fostering group engagement, enhancing safety protocols, and increasing technical support. TRIAL REGISTRATION: ClinicalTrials.gov NCT03440320; https://clinicaltrials.gov/ct2/show/NCT03440320.

Disutility of injectable therapies in obesity and type 2 diabetes mellitus: general population preferences in the UK, Canada, and China.

INTRODUCTION: Once-daily and once-weekly injectable glucagon-like peptide-1 receptor agonist therapies (GLP-1 RAs) are established in obesity and type 2 diabetes mellitus (T2DM). In T2DM, both once-daily and once-weekly insulin are expected to be available. This study elicited utilities associated with these treatment regimens from members of the general public in the UK, Canada, and China, to quantify administration-related disutility of more-frequent injectable treatment, and allow economic modelling. METHODS: Two anchor states (no pharmacological treatment), and seven treatment states (daily oral tablet and generic injectable regimens of variable frequency), with identical outcomes were tested A broadly representative sample of the general public in each country participated (excluding individuals with diabetes or pharmacologically treated obesity). An adapted Measurement and Valuation of Health protocol was administered 1:1 in web-enabled interviews by trained moderators: visual analogue scale (VAS) as a "warm-up", and time trade-off (TTO) using a 20-year time horizon for utility elicitation. RESULTS: A total of 310 individuals participated. The average disutility of once-daily versus once-weekly GLP-1 RA was - 0.048 in obesity and - 0.033 in T2DM; the corresponding average disutility for insulin was - 0.064. Disutilities were substantially greater in China, relative to UK and Canada. DISCUSSION: Within obesity and T2DM, more-frequent treatment health states had lower utility. Scores by VAS also followed a logical order. The generated utility values are suitable for use in modelling injectable therapy regimens in obesity and T2DM, due to the use of generic descriptions and assumption of equal efficacy. Future research could examine the reasons for greater administration-related disutility in China.

Matching Exercise Volume in Active Control Groups for Yoga Interventions.

Context: The selection of a control group should foremost be determined by the study's primary intended outcome and trial design. When examining the effects of the physical movements that comprise yoga postures, an active control group, with physical exercise as the control, is often recommended. Objective: The current study aimed to define an active control group that participates in physical exercise, emphasizing the importance of matching the exercise's volume to that of an intervention group's yoga, and to provide a tangible example from a federally funded, recently completed, randomized controlled trial. Design: The research team designed a control group, providing a case study as a example of it. Setting: The study took place at Colorado State University. Intervention: The exercise component for the control group included 60 minutes of low-intensity exercise, matched with 60 minutes of Hatha yoga for the intervention group. Because the intervention included chronic pain self-management in addition to the exercise component, the education component for the control group included 45 minutes of group-based, general health-and-wellness education and discussion. Conclusions: Future randomized trials for yoga and other complementary or integrative health interventions should continue to use appropriate active control groups, which will serve to enhance the scientific rigor of conclusions that can be drawn with respect to the effectiveness of these interventions.

Manual development for a multi-modal, dyadic intervention for persistent pain: A Qualitative Study.

Background: People who experience persistent pain often require help from a family member, partner, or friend. These caregivers frequently have pain but are often not included in interventions. Caregivers and care receivers who both experience pain are more likely to be socially isolated, and experience communication conflict and decreased quality of life. Interventions should target caregiving dyads to help them manage their pain together. However, there are few intervention manuals or research protocols developed to support the dyad. Objective: The purpose of this qualitative study was to explore the needs of caregiving dyads, including input from dyads and medical and allied health experts to inform the development of an intervention manual for dyads with persistent pain. Method: A total of 16 caregiving dyads experiencing persistent pain, one care receiver (caregiver could not participate), and 8 health experts, recruited from the community, participated in focus groups. Data were transcribed verbatim, uploaded into NVivo software, and analyzed using constant comparison qualitative methods. Results: Findings identified the importance of a new intervention to focus on modifiable approaches to managing pain as a dyad, addressing the emotional and psychological effects of experiencing pain as a dyad, and careful consideration of logistics to implement an intervention with dyads in persistent pain. Conclusion: These results highlight important considerations to meet the needs of caregiving dyads with pain. This study informed the development of the MY-Skills intervention, a novel program that merges self-management education with adaptive yoga to treat persistent pain in caregiving dyads.

Positive Health Behavior Changes in Custodial Grandparents and Grandchildren Following an Intervention.

BACKGROUND: Custodial grandparents experience greater physical health declines and higher rates of depression than their same-age peers who do not provide care, and grandchildren in grandfamilies often have behavior problems. However, few researchers have explored the impact of self-care education on decreasing these negative outcomes. Our study examined how a self-care and life-skills intervention influenced health behavior change in a sample of grandparents and grandchildren. METHODS: Data were collected during eleven focus groups (and two interviews) with 55 grandparents, and one focus group with five grandchildren, at 6 months after the 6-week intervention detailed in this paper. Grandparents ranged in age from 46 to 84 years old (M = 62.19, SD = 8.24). Participating grandchildren ranged in age from 9 to 12 years old. Focus group transcripts were coded for content related to grandparents' and grandchildren's positive behavior changes following the intervention. FINDINGS: Grandparents reported taking more time for themselves, reducing negative self-talk, increasing healthy physical choices, and having better communication skills after participating in the intervention. Similarly, grandchildren reported increased confidence in making friends, making good decisions, and getting along with others. Findings suggest that a self-care and life skills program show promise for improving the health and wellness of grandfamilies.

Program Evaluation of Population- and System-Level Policies: Evidence for Decision Making.

BACKGROUND: Policy evaluations often focus on ex post estimation of causal effects on short-term surrogate outcomes. The value of such information is limited for decision making, as the failure to reflect policy-relevant outcomes and disregard for opportunity costs prohibits the assessment of value for money. Further, these evaluations do not always consider all relevant evidence, other courses of action, or decision uncertainty. METHODS: In this article, we explore how policy evaluation could better meet the needs of decision making. We begin by defining the evidence required to inform decision making. We then conduct a literature review of challenges in evaluating policies. Finally, we highlight potential methods available to help address these challenges. RESULTS: The evidence required to inform decision making includes the impacts on the policy-relevant outcomes, the costs and associated opportunity costs, and the consequences of uncertainty. Challenges in evaluating health policies are described using 8 categories: 1) valuation space; 2) comparators; 3) time of evaluation; 4) mechanisms of action; 5) effects; 6) resources, constraints, and opportunity costs; 7) fidelity, adaptation, and level of implementation; and 8) generalizability and external validity. Methods from a broad set of disciplines are available to improve policy evaluation, relating to causal inference, decision-analytic modeling, theory of change, realist evaluation, and structured expert elicitation. LIMITATIONS: The targeted review may not identify all possible challenges, and the methods covered are not exhaustive. CONCLUSIONS: Evaluations should provide appropriate evidence to inform decision making. There are challenges in evaluating policies, but methods from multiple disciplines are available to address these challenges. IMPLICATIONS: Evaluators need to carefully consider the decision being informed, the necessary evidence to inform it, and the appropriate methods.[Box: see text].

Reference Case Methods for Expert Elicitation in Health Care Decision Making.

BACKGROUND: The evidence used to inform health care decision making (HCDM) is typically uncertain. In these situations, the experience of experts is essential to help decision makers reach a decision. Structured expert elicitation (referred to as elicitation) is a quantitative process to capture experts' beliefs. There is heterogeneity in the existing elicitation methodology used in HCDM, and it is not clear if existing guidelines are appropriate for use in this context. In this article, we seek to establish reference case methods for elicitation to inform HCDM. METHODS: We collated the methods available for elicitation using reviews and critique. In addition, we conducted controlled experiments to test the accuracy of alternative methods. We determined the suitability of the methods choices for use in HCDM according to a predefined set of principles for elicitation in HCDM, which we have also generated. We determined reference case methods for elicitation in HCDM for health technology assessment (HTA). RESULTS: In almost all methods choices available for elicitation, we found a lack of empirical evidence supporting recommendations. Despite this, it is possible to define reference case methods for HTA. The reference methods include a focus on gathering experts with substantive knowledge of the quantities being elicited as opposed to those trained in probability and statistics, eliciting quantities that the expert might observe directly, and individual elicitation of beliefs, rather than solely consensus methods. It is likely that there are additional considerations for decision makers in health care outside of HTA. CONCLUSIONS: The reference case developed here allows the use of different methods, depending on the decision-making setting. Further applied examples of elicitation methods would be useful. Experimental evidence comparing methods should be generated.

Estimating the shares of the value of branded pharmaceuticals accruing to manufacturers and to patients served by health systems.

Previous studies have estimated that patients served by health systems accrue 59-98% of the value generated by new pharmaceuticals. This has led to questions about whether sufficient returns accrue to manufacturers to incentivize socially optimal levels of R&D. These studies have not, however, fully reflected the health opportunity costs imposed by payments for branded pharmaceuticals. We present a framework for estimating how the value generated by new branded pharmaceuticals is shared. We quantify value in net health effects and account for benefits and health opportunity costs in the patent period and post-patent period when generic/biosimilar products become available. We apply the framework to 12 National Institute for Health and Care Excellence appraisals and show that realized net health effects range from losses of 160%, to gains of 94%, of the potential net health benefits available. In many cases, even in the long run, the benefits of new medicines are not sufficient to offset the opportunity costs of payments to manufacturers, and approval is expected to reduce population health. This cannot be dynamically efficient as it incentivizes future innovation at prices which will also reduce population health. Further work should consider how to reflect these findings in reimbursement policies.

Developing a reference protocol for structured expert elicitation in health-care decision-making: a mixed-methods study.

BACKGROUND: Many decisions in health care aim to maximise health, requiring judgements about interventions that may have higher health effects but potentially incur additional costs (cost-effectiveness framework). The evidence used to establish cost-effectiveness is typically uncertain and it is important that this uncertainty is characterised. In situations in which evidence is uncertain, the experience of experts is essential. The process by which the beliefs of experts can be formally collected in a quantitative manner is structured expert elicitation. There is heterogeneity in the existing methodology used in health-care decision-making. A number of guidelines are available for structured expert elicitation; however, it is not clear if any of these are appropriate for health-care decision-making. OBJECTIVES: The overall aim was to establish a protocol for structured expert elicitation to inform health-care decision-making. The objectives are to (1) provide clarity on methods for collecting and using experts' judgements, (2) consider when alternative methodology may be required in particular contexts, (3) establish preferred approaches for elicitation on a range of parameters, (4) determine which elicitation methods allow experts to express uncertainty and (5) determine the usefulness of the reference protocol developed. METHODS: A mixed-methods approach was used: systemic review, targeted searches, experimental work and narrative synthesis. A review of the existing guidelines for structured expert elicitation was conducted. This identified the approaches used in existing guidelines (the 'choices') and determined if dominant approaches exist. Targeted review searches were conducted for selection of experts, level of elicitation, fitting and aggregation, assessing accuracy of judgements and heuristics and biases. To sift through the available choices, a set of principles that underpin the use of structured expert elicitation in health-care decision-making was defined using evidence generated from the targeted searches, quantities to elicit experimental evidence and consideration of constraints in health-care decision-making. These principles, including fitness for purpose and reflecting individual expert uncertainty, were applied to the set of choices to establish a reference protocol. An applied evaluation of the developed reference protocol was also undertaken. RESULTS: For many elements of structured expert elicitation, there was a lack of consistency across the existing guidelines. In almost all choices, there was a lack of empirical evidence supporting recommendations, and in some circumstances the principles are unable to provide sufficient justification for discounting particular choices. It is possible to define reference methods for health technology assessment. These include a focus on gathering experts with substantive skills, eliciting observable quantities and individual elicitation of beliefs. Additional considerations are required for decision-makers outside health technology assessment, for example at a local level, or for early technologies. Access to experts may be limited and in some circumstances group discussion may be needed to generate a distribution. LIMITATIONS: The major limitation of the work conducted here lies not in the methods employed in the current work but in the evidence available from the wider literature relating to how appropriate particular methodological choices are. CONCLUSIONS: The reference protocol is flexible in many choices. This may be a useful characteristic, as it is possible to apply this reference protocol across different settings. Further applied studies, which use the choices specified in this reference protocol, are required. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 37. See the NIHR Journals Library website for further project information. This work was also funded by the Medical Research Council (reference MR/N028511/1).

BACKGROUND: Decisions in health care aim to maximise health, requiring judgements about treatments. The evidence used to make these judgements is typically uncertain. In these situations, the experience of experts is essential. Structured expert elicitation collects beliefs from experts. There are different guidelines available for structured expert elicitation; however, it is not clear if any of these be can be used in health-care decision-making, for example in considering if a treatment should be made available in the NHS. This project aimed to develop a guidance for structured expert elicitation to inform health-care decision-making. METHODS: Reviews and experimental techniques were used to gather a list of methods to conduct structured expert elicitation. The suitability of these choices in health-care decision-making was then determined by comparing these with a set of standards that support the use of structured expert elicitation in health-care decision-making. RESULTS: Different guidelines prefer different approaches to conduct structured expert elicitation. There is a lack of evidence available to determine which of these methods is most appropriate across the whole of health-care decision-making. It is possible to define reference protocol methods that could be used in a particular type of health-care decision-making, health technology assessment. This includes gathering experts with knowledge of the clinical area, asking experts about things that they observe in clinical practice and asking experts individually for their beliefs. For decision-makers working outside health technology assessment, for example at a local level, or for treatments that are not yet available to patients, these choices may not be appropriate. CONCLUSIONS: This flexibility of this guidance is a useful feature. It is possible for different decision-makers in health care to interpret the reference protocol for their own circumstances.

Estimating the Cost of Preeclampsia in the Healthcare System: Cross-Sectional Study Using Data From SCOPE Study (Screening for Pregnancy End Points).

To estimate the cost of preeclampsia from the national health payer's perspective using secondary data from the SCOPE study (Screening for Pregnancy End Points). SCOPE is an international observational prospective study of healthy nulliparous women with singleton pregnancies. Using data from the Irish cohort recruited between November 2008 and February 2011, all women with preeclampsia and a 10% random sample of women without preeclampsia were selected. Additional health service use data were extracted from the consenting participants' medical records for maternity services which were not included in SCOPE. Unit costs were based on estimates from 3 existing Irish studies. Costs were extrapolated to a national level using a prevalence rate of 5% to 7% among nulliparous pregnancies. Within the cohort of 1774 women, 68 developed preeclampsia (3.8%) and 171 women were randomly selected as controls. Women with preeclampsia used higher levels of maternity services. The average cost of a pregnancy complicated by preeclampsia was €5243 per case compared with €2452 per case for an uncomplicated pregnancy. The national cost of preeclampsia is between €6.5 and €9.1 million per annum based on the 5% to 7% prevalence rate. Postpartum care was the largest contributor to these costs (€4.9-€6.9 million), followed by antepartum care (€0.9-€1.3 million) and peripartum care (€0.6-€0.7 million). Women with preeclampsia generate significantly higher maternity costs than women without preeclampsia. These cost estimates will allow policy-makers to efficiently allocate resources for this pregnancy-specific condition. Moreover, these estimates are useful for future research assessing the cost-effectiveness of preeclampsia screening and treatment.