Shared decision-making (SDM), a process whereby physicians and patients collaborate to select interventions, is not well understood for biologic treatment of autoimmune conditions.
This was a ...cross-sectional survey of adults initiating treatment for Crohn's disease or ulcerative colitis (inflammatory bowel disease, IBD) or psoriatic arthritis or rheumatoid arthritis (RA/PA). Survey data were linked to administrative claims for 6 months before (baseline) and after (follow-up) therapy initiation. Measures included the Shared Decision Making Questionnaire, Patient Activation Measure (PAM), Morisky Medication Adherence Scale (MMAS), general health, and treatment satisfaction. Claims-based Quan-Charlson comorbidity scores, persistence, medication possession ratio (MPR), and health care costs were examined. Patients were compared by participation (SDM) and nonparticipation (non-SDM) in SDM.
Among 453 respondents, 357 were eligible, and 306 patients (204 RA/PA and 102 IBD) were included in all analyses. Overall (n=357), SDM participants (n=120) were more often females (75.0% vs 62.5%,
=0.018), had lower health status (48.0 vs 55.4,
=0.005), and higher Quan-Charlson scores (1.0 vs 0.7,
=0.035) than non-SDM (n=237) participants. Lower MMAS scores (SDM 0.17 vs non-SDM 0.41;
<0.05) indicated greater likelihood of adherence; SDM participants also reported higher satisfaction with medication and had greater activation (PAM: SDM vs non-SDM: 66.9 vs 61.6;
<0.001). Mean MPR did not differ, but persistence was longer among SDM participants (111.2 days vs 102.2 days for non-SDM;
=0.029). Costs did not differ by SDM status overall, or among patients with RA/PA. The patients with IBD, however, experienced lower (
=0.003) total costs ($9,404 for SDM vs $25,071 for non-SDM) during follow-up.
This study showed greater likelihood of adherence and satisfaction for patients who engaged in SDM and reduced health care costs among patients with IBD who engaged in SDM. This study provides a basis for defining SDM participation and detecting differences by SDM participation for biologic treatment selection for autoimmune conditions.
Abstract
Objective
The aim of the present study was to analyse the incidence, prevalence, mortality and cause of death data of adult SLE patients and matched controls in a full-populational, ...nationwide, retrospective study.
Methods
This non-interventional study was based on database research of the National Health Insurance Fund of Hungary. A total of 7888 patients were included in the analyses, within which two subgroups of incident patients were created: the ‘All incident SLE patients’ group consisted of all incident SLE patients (4503 patients), while the ‘Treated SLE patients’ group contained those who received relevant therapy in the first 6 months after diagnosis (2582 patients).
Results
The median age of the SLE population was found to be 46.5 years (women 85%). The incidence rate was 4.86 and 2.78 per 100 000 inhabitants in the ‘All incident SLE patients’ and ‘Treated SLE patients’ groups, respectively. The standardized mortality ratio was 1.63 and 2.09 in the ‘All incident SLE patients’ and ‘Treated SLE patients’ groups, respectively. Overall survival was significantly lower (P < 0.001) in both groups than in the general population, with hazard ratio = 2.17 in the ‘All incident SLE patients’ group and hazard ratio = 2.75 in the ‘Treated SLE patients’ group. There was no significant difference between SLE and control deaths regarding cerebrovascular conditions as the cause of death. Generally, cancer-related deaths were less common, while haematological cancer and infection-related deaths were more common in SLE patients.
Conclusion
Infections, especially sepsis, had the largest positive effect on top of the extra mortality of SLE. This highlights that SLE patients are at increased risk of infection-related death.
Aims: Systemic lupus erythematosus (SLE) is a multifaceted autoimmune disease involving multiple organs systems and places a significant economic burden on SLE patients. There is a literature gap ...regarding the standard of care and economic burden in SLE patients, their families, and society. This study assessed medication use patterns among SLE patients and generated the annual and total economic burden associated with the illness.
Materials and methods: Adult patients with ≥2 medical claims on different dates for SLE diagnoses were identified from 01 January 2013 to 31 December 2015 using two large administrative claims databases representative of the commercially insured US population. Patient demographics and clinical characteristics during 1-year pre-SLE diagnosis were assessed. Outcomes including the proportion of patients who used SLE medications and annual costs were assessed 1-year post-SLE diagnosis. Total costs related to SLE were extrapolated to the US population to estimate the economic burden based on SLE prevalence.
Results: A total of 30,086 SLE patients were identified. The most common baseline comorbidities were hypertension and infections. Corticosteroids and hydroxychloroquine were the most common SLE medications. Biologics utilization was minimal. SLE patients had, on average, 26.0 physician visits, 23.7 prescription claims, 1.7 inpatient admissions, and 2.0 hospital days per patient 1-year post-SLE diagnosis. Annual all-cause median costs among all SLE patients were $8712 per patient per year. Total costs ranged between $1.4-1.6 and $2.8-3.2 billion per year, depending on prevalence estimates.
Conclusions: Our findings indicate a nominal use of biologics (∼2%) among SLE patients; despite belimumab being one of the few approved treatments for SLE in the USA. These data reveal an unmet need for availability of advanced SLE therapy, and future studies are warranted concerning the underlying causes. SLE is also associated with a substantial economic burden of ≤3.2 billion per year. These findings may assist in future planning and resource allocation.
Objective
To identify discrete clusters of systemic lupus erythematosus (SLE) patients based on symptoms and investigate differences across clusters.
Methods
Data were collected in the US and 5 ...European countries via the Adelphi Real World Lupus Disease Specific Programme, a cross‐sectional survey. Rheumatologists provided data for 5 consecutively consulting adult patients with SLE, who were invited to participate. Identified SLE symptoms were reduced to factors based on commonly concurrent symptoms, using principal‐component factor analysis. Factors were used as covariates in a latent‐class cluster analysis to identify discrete patient clusters. Patient‐reported outcomes and physician‐reported data were compared across clusters.
Results
Among 1,376 patients, 87% were female and 74% were White. We identified 4 patient clusters (very mild, mild, moderate, and severe) based on 39 signs/symptoms. Physician‐reported symptom burden, organ involvement, disease activity, and the number of flares increased with increasing cluster severity (P < 0.0001). Patient‐reported impact (health status, fatigue, work productivity impairment, anxiety/depression, and emotional impact) increased with increasing cluster severity (P < 0.0001). Glucocorticoid and immunosuppressant use increased, and antimalarial use decreased, with increasing cluster severity. In all clusters, <20% of patients received biologics; >15% of patients not receiving biologics were considered eligible for treatment by their physician. The proportion of physicians and patients satisfied with treatment decreased with increasing cluster severity (P < 0.0001).
Conclusion
Our large, international, real‐world survey of SLE patients and physicians demonstrated strong associations between increased impairment, organ involvement, and humanistic burden in SLE, highlighting an unmet need for effective treatment options in patients with high disease activity.
The objective of this review was to identify health-related workplace productivity loss survey instruments, with particular emphasis on those that capture a metric suitable for direct translation ...into a monetary figure. A literature search using Medline, HealthSTAR, PsycINFO and Econlit databases between 1966 and 2002, and a telephone-administered survey of business leaders and researchers, were conducted to identify health-related workplace productivity measurement survey instruments. This review was conducted from the societal perspective. Each identified instrument was reviewed for the following: (i). reliability; (ii). content validity; (iii). construct validity; (iv). criterion validity; (v). productivity metric(s); (vi). instrument scoring technique; (vii). suitability for direct translation into a monetary figure; (viii). number of items; (ix). mode(s) of administration; and (x). disease state(s) in which it had been tested. Reliability and validity testing have been performed for 8 of the 11 identified surveys. Of the 11 instruments identified, six captured metrics that are suitable for direct translation into a monetary figure. Of those six, one instrument measured absenteeism, while the other five measured both absenteeism and presenteeism. All of the identified instruments except for one were available as paper, self-administered questionnaires and many were available in languages other than English. This review provides a comprehensive overview of the published, peer-reviewed survey instruments available to measure health-related workplace productivity loss. As the field of productivity measurement matures, tools may be developed that will allow researchers to accurately calculate lost productivity costs when performing cost-effectiveness and cost-benefit analyses. Using data captured by these instruments, society and healthcare decision makers will be able to make better informed decisions concerning the value of the medications, disease management and health promotion programmes that individuals receive.
Introduction
Vitiligo is a chronic autoimmune disease characterized by destruction of melanocytes, leading to skin depigmentation. Vitiligo can have a high quality-of-life burden and profound impact ...on psychosocial well-being. The objectives of this study were to describe the self-reported patient burden among patients with nonsegmental vitiligo with ≤ 10% affected body surface area, summarize the physician-reported psychosocial and psychological impact of vitiligo on patient lives, and describe disease characteristics and treatment history, goals, and satisfaction.
Methods
Data were drawn from the Adelphi Vitiligo Disease Specific Programme™, a real-world, cross-sectional survey with retrospective data collection of physicians and patients with vitiligo, collected in the United States between October 2021 and April 2022. Separate surveys for dermatologists and patients contained questions on clinical and demographic characteristics of patients with vitiligo and burden of vitiligo. Treatment history, goals, and satisfaction were assessed together with the impact of vitiligo on quality of life.
Results
Sixty-one dermatologists provided data for 326 patients with ≤ 10% affected body surface area (adults,
n
= 221; adolescents,
n
= 105); 90 of those patients also responded to the survey. The most common treatments were topical corticosteroids, topical calcineurin inhibitors, and narrow-band ultraviolet-B phototherapy, with the main treatment goal being repigmentation. Physician-reported treatment satisfaction was 56%; 25% of patients reported frustration with treatment options. Physicians reported impact of vitiligo on everyday life in 46% of patients. Patients reported 12.7% overall work impairment; mean scores for Hospital Anxiety and Depression Scale anxiety and depression domains were 3.5 and 2.2, respectively, and mean Vitiligo-specific Quality of Life index score was 26.9. Patients with facial involvement experienced higher burden than those without.
Conclusion
A high patient burden was reported by dermatologists and their patients with vitiligo who had ≤ 10% affected body surface area, including psychosocial and psychological consequences. These findings highlight an unmet need in the treatment of vitiligo.
Plain Language Summary
Vitiligo is a chronic disease in which cells that produce the skin pigment melanin are attacked, causing patches of skin to lose color and become pale. Vitiligo can have emotional impacts such as social or psychological distress that can affect the day-to-day well-being of individuals. However, there is a lack of studies that assess the ways that vitiligo affects the everyday lives of people with the condition in the United States. Dermatologists and people with vitiligo answered survey questions on treatment goals, any vitiligo treatments currently and previously used, and how satisfied they were with the results of treatment. The surveys also contained questions that assessed the impact of vitiligo on everyday life. Sixty-one dermatologists answered questions about 326 patients and 90 of those patients also provided their own answers to the survey questions. Both dermatologists and patients reported that restoring color to patches of pale skin was their goal in treating vitiligo. However, dermatologists and patients both reported that they were dissatisfied with the results of available treatments. Dermatologists and patients both reported that vitiligo impacted aspects of everyday life. Emotional and psychological impacts such as anxiety and depression were reported, as well as negative effects on patients’ work and social lives due to vitiligo. These results confirm that vitiligo impacts the day-to-day well-being of patients. Furthermore, this study highlights that there is a need for improvements in the treatment of vitiligo.
Background
Atopic dermatitis is a chronic inflammatory skin disease that can negatively impact work productivity and daily activities. Ruxolitinib cream, a Janus kinase inhibitor, demonstrated ...efficacy and safety in patients with atopic dermatitis in two phase III studies (TRuE-AD1 and TRuE-AD2).
Objective
This post hoc analysis sought to describe the effects of ruxolitinib cream on work productivity and activity impairment from pooled data from the phase III studies, to estimate indirect costs due to atopic dermatitis, and to estimate the incremental cost savings with ruxolitinib cream versus vehicle cream.
Methods
Patients in both studies were ≥ 12 years old with atopic dermatitis for ≥ 2 years, an Investigator’s Global Assessment score of 2 or 3, and a 3–20% affected body surface area at baseline. Patients were randomized 2:2:1 to receive ruxolitinib cream (0.75% or 1.5%) or vehicle cream for 8 weeks. Patient self-reported productivity in the efficacy-evaluable population was assessed at weeks 2, 4, and 8 using the Work Productivity and Activity Impairment Questionnaire-Specific Health Problem version 2.0. Statistical significance for the two doses versus vehicle was calculated using an analysis of covariance. Work Productivity and Activity Impairment overall work impairment scores were converted to a model of costs per employed patient due to lost productivity and incremental cost savings from ruxolitinib cream treatment using a human capital approach.
Results
Of 1249 patients enrolled (median age, 32 years; female sex, 61.7%), 1208 were included in the efficacy-evaluable population. Patients applying 0.75% or 1.5% ruxolitinib cream had significant changes in overall work impairment (− 17.9% 0.75% strength and − 15.0% 1.5% strength vs − 5.7% for vehicle;
p
< 0.0001 for both) and daily activity impairment (− 20.6% 0.75% strength and − 21.5% 1.5% strength vs − 10.6% for vehicle;
p
< 0.0001 for both). These corresponded to estimated lost productivity costs in 2021 US dollars of $1313 (0.75% strength) and $1242 (1.5% strength) versus $2008 (vehicle) over the 8-week trial period. Compared with a patient receiving vehicle, incremental annual indirect cost savings were estimated to be $5302 with 0.75% ruxolitinib cream and $4228 with 1.5% ruxolitinib cream.
Conclusions
Ruxolitinib cream therapy is associated with improved work productivity and daily activity compared with vehicle and is estimated to reduce the indirect cost burden on the patient.
Clinical trial registration
ClinicalTrials.gov identifiers: NCT03745638 (registered 19 November, 2018) and NCT03745651 (registered 19 November, 2018)
Background
Crohn’s disease (CD) and ulcerative colitis (UC) are chronic, debilitating conditions that can have important economic and clinical implications.
Aim
To quantify individual and national ...estimates of the health care and patient out-of-pocket (OOP) costs of CD and UC.
Methods
In a retrospective study using 1996 to 2009 data from the Medical Expenditure Panel Survey, individuals’ self-reported health conditions were mapped to International Classification of Diseases, Ninth Revision, Clinical Modification diagnostic codes. Individuals with a code of 555.x (CD) or 556.x (UC) were identified. Health care services and costs included prescriptions and inpatient, outpatient, emergency room, office, and home health services. OOP costs were the portion of individuals’ total payments for health care services.
Results
There were 358 individuals with CD (mean age 49.0 years; 55 % female), 198 individuals with UC (mean age 47.1 years; 64 % female), and 206,993 individuals without inflammatory bowel disease (IBD) (mean age 48.2 years; 58 % female). Annual per capita health insurer and OOP costs for individuals with CD were greater than those without IBD ($9,526 versus $3,781,
p
< 0.001 and $1,603 versus $866,
p
< 0.001, respectively). Health insurer and OOP costs were greater for UC compared with those without IBD ($6,443 versus $3,781,
p
< 0.001 and $1,263 versus $866,
p
< 0.001, respectively). US national aggregate annual estimates of health insurer, OOP, and total direct costs secondary to CD are $2.04 billion, $0.26 billion, and $2.29 billion, respectively. Aggregate health insurer, OOP, and total direct costs attributable to UC are $0.53 billion, $0.07 billion, and $0.61 billion, respectively.
Conclusions
The direct costs associated with CD and UC are substantial. The extent to which appropriate diagnosis and treatment reduces the total health care costs for individuals with CD or UC should be examined.
Introduction
Patients with atopic dermatitis (AD) experience burdensome symptoms and impaired quality of life (QoL). The objective of this study was to investigate the effects of topical AD therapies ...on disease control, physician and patient treatment satisfaction, and QoL in a real-world setting.
Methods
This was a retrospective, point-in-time study of physician-completed medical records and patient surveys drawn from two Adelphi AD Disease Specific Programmes™ (1. adults ≥ 18 years old; 2. pediatrics ≤ 17 years old) in the USA. Eligible physicians completed patient record forms and provided disease control assessments. Physicians and matched patients were surveyed regarding their satisfaction with current treatment. Patient-reported outcomes included the Dermatology Life Quality Index (DLQI), Children’s DLQI (CDLQI), Patient-Oriented Eczema Measure (POEM), and the Work Productivity and Activity Impairment (WPAI) questionnaire.
Results
A total of 394 adult (topicals only,
n
= 284; topical plus systemic,
n
= 110) and 144 adolescent (aged 12–17 years; topicals only,
n
= 114; topical plus systemic,
n
= 30) patients who had received their current treatment for at least 1 month were included. Overall, 24.5% of patients had physician-reported uncontrolled disease (adults, 22.8%; adolescents, 29.2%). Rates of physician- and patient-reported dissatisfaction with current treatment were 32.0% (adults, 28.2%; adolescents, 42.4%) and 24.8% (adults, 24.0%; adolescents, 26.8%), respectively, and were higher for patients with uncontrolled versus controlled disease. Poorer disease control and higher rates of treatment dissatisfaction were generally reported among patients receiving topical plus systemic therapy versus topicals alone. Patients with uncontrolled versus controlled disease reported more impairment in the DLQI, CDLQI, POEM, and WPAI (
P
< 0.05 for all), with generally greater impairments observed among patients on topical plus systemic therapy versus topicals alone.
Conclusion
Patients receiving topical AD therapies experienced uncontrolled disease and reported decreased overall functioning and lower QoL. An unmet need for topical AD treatments that improve disease control and patient outcomes exists.
Plain Language Summary
Atopic dermatitis (or eczema) is a common skin condition that causes dry, cracked, and itchy skin. Patients are frequently prescribed topical therapy, such as ointments and creams, to apply directly to the affected skin. Additionally, patients may be prescribed systemic therapies, which are oral or injectable medications that work throughout the entire body. This study included 394 adults and 144 adolescents (aged 12–17 years) with atopic dermatitis. All patients in the study were receiving topical therapy, and some received both topical and systemic therapy. The goal of the study was to evaluate how satisfied patients and their doctors were with current treatment and to learn how patients in the study felt about their quality of life. Patients and their doctors completed surveys that asked about feelings, symptoms, and whether their condition affects their work. The study results showed that patients had high levels of dissatisfaction with their treatment. Doctors reported that between one-fifth and one-quarter of adult patients and up to one-half of adolescent patients had uncontrolled disease (defined as changeable or worsening). Patients with uncontrolled disease reported higher dissatisfaction with their therapy and a negative outlook on their quality of life versus those with controlled disease (defined as stable or improving by their doctors). In summary, doctors and their patients currently using topical medications to treat atopic dermatitis reported that treatments were not working well enough and that uncontrolled disease was negatively affecting patients’ quality of life and work, indicating that additional treatment options are needed.
Background
There is limited information on gastroenterologists’ perspectives of shared decision making (SDM) in discussions of therapeutic agents with inflammatory bowel disease (IBD) patients.
Aims
...To examine gastroenterologists’ perspectives about SDM with IBD patients, using a novel statistical hybrid approach to analyze qualitative data.
Methods
Physician interviews and online surveys were conducted from a panel of gastroenterologists in April 2012. Gastroenterologists were asked about their barriers to SDM, SDM practices, relationship to their patients, knowledge of SDM, and insights into SDM implementation. Key audio excerpts adapted from the interviews were used for moment-to-moment affect trace analysis in an online survey. Cluster analysis was used to segment gastroenterologists into mutually exclusive provider groups.
Results
One hundred and six gastroenterologists completed the survey (88 % male; 55 % ≤ 50 years of age). Over three-fourths of gastroenterologists were familiar with SDM (77 %). The vast majority of gastroenterologists (80 %) tried to use a form of SDM with their patients; only 12 % stated that they have a systematic, consistent, and formally documented approach to SDM. Three unique physician clusters were identified: SDM Believers (20 %,
n
= 20); SDM Skeptics (47 %,
n
= 47); and SDM Enthusiasts (34 %,
n
= 34). The three key barriers to practicing SDM were lack of the following: time (74 %), reimbursement (70 %), and tools (51 %). Twenty-two percent of gastroenterologists do not currently use SDM tools.
Conclusions
Gastroenterologists lack the systematic approaches and tools for implementing SDM within their IBD practices. These data offer a foundation for future research in developing and testing SDM programs for gastroenterologists and their IBD patients.
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