Search

This study examined the real-world use of nivolumab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). This was a multinational retrospective study (VOLUME) assessing treatment effectiveness and safety outcomes and a prospective study (VOLUME-PRO) assessing HRQoL and patient-reported symptoms. There were 447 and 51 patients in VOLUME and VOLUME-PRO, respectively. Across both studies, the median age was 64.0 years, 80.9% were male, and 52.6% were former smokers. Clinical outcomes of interest included real-world overall survival (rwOS) and real-world progression-free survival (rwPFS). The median rwOS was 9.2 months. Among patients with at least one assessment, 21.7% reported their best response as ‘partial response’, with 3.9% reporting ‘complete response’. The median duration of response (DoR) and median rwPFS were 11.0 months and 3.9 months, respectively. At baseline, VOLUME-PRO patients reported difficulties relating to fatigue, physical and sexual functioning, dyspnea, nausea, sticky saliva, dry mouth, pain/discomfort, mobility, and financial difficulties. There were improvements in social functioning and financial difficulties throughout the study; however, no other clinically meaningful changes were noted. No new safety concerns were identified. This real-world, multinational, multicenter, retrospective and prospective study supports the effectiveness and safety of nivolumab for R/M SCCHN patients.

To determine, in a European cohort, the prevalence and health-related quality-of-life (QOL) burden of moderate-to-severe vasomotor symptoms (VMS) in postmenopausal women, and among subgroups of women not taking hormone therapy (HT).Screening surveys were sent to a random sample of women aged 40-65 years; those meeting the inclusion criteria completed the full questionnaire. Women with successfully treated VMS or breast cancer or who were receiving HT for medical conditions were excluded.Frequency and duration of VMS, perceptions of menopause, seeking advice from a healthcare professional, treatment for VMS symptoms, perceptions of HT use, out-of-pocket costs, and other approaches to coping with menopause. The Menopause-Specific QOL (MENQOL) questionnaire and Work Productivity and Activity Impairment (WPAI) questionnaire were included.Of 11,452 women who completed the screening survey, 5178 were postmenopausal and 2035 completed the full questionnaire. Prevalence of moderate-to-severe VMS ranged from 31 % in France to 52 % in Italy. The majority were in the HT-caution or HT-averse group, despite being eligible for HT. Most common menopausal symptoms reported in the MENQOL were "feeling tired or worn out," with aching in muscles and joints reported as the most common symptom in Spain. Weight gain was the most bothersome symptom in all countries, except for Spain, where low backache was more bothersome. Hot flashes and night sweats had a greater impact on daily than on working activities, as measured by the WPAI.A high proportion of European women reported experiencing moderate-to-severe VMS, with associated symptoms influencing QOL.

Objective: To determine prevalence and health-related quality of life (HRQOL) of moderate-to-severe vasomotor symptoms (VMS) in postmenopausal women in Europe, the US, and Japan, and among subgroups of women not taking hormone therapy (HT). Methods: Screening surveys were sent to a random sample of women aged 40 to 65 years; full questionnaires followed to those who completed them and met inclusion criteria. Women with successfully treated VMS, breast cancer, or on HT for medical conditions were excluded. The Menopause-Specific QOL (MENQOL) and Work Productivity and Activity Impairment (WPAI) questionnaires were included in the questionnaire. Results: Of 25,161 women completing the screening survey, 11,771 were postmenopausal and 3,460 met inclusion criteria and completed the full questionnaire. Prevalence of moderate-to-severe VMS was 40%, 34%, and 16% in Europe, the US, and Japan, respectively. A large proportion were HT averse, albeit eligible (Europe 56%, US 54%, Japan 79%). In total, 12%, 9%, and 8% in Europe, the US, and Japan, respectively, were HT-contraindicated. A high proportion were HT-cautious (Europe 70%, US 69%, Japan 52%). Most common menopausal symptoms reported in the MENQOL were feeling tired or worn out (Europe/US 74%, Japan 75%), aching in muscles and joints (Europe 69%, US 68%, Japan 61%), difficulty sleeping (Europe 69%, US 66%, Japan 60%), and hot flashes (Europe 67%, US 68%, Japan 62%). Overall, the most bothersome symptom was weight gain. As measured by the WPAI, hot flashes and night sweats had a greater impact on daily activities than on working activities. Conclusions: A high proportion of women experienced moderate-to-severe VMS, with associated symptoms impacting QOL.

Background: For patients with VTE, current American Society of Hematology (ASH) guideline panel suggests using direct oral anticoagulants (DOACs) over vitamin K antagonists (VKAs) where VKAs are required to be bridged with a parenteral anticoagulant (PAC). For patients with VTE and cancer, current guidelines recommend DOACs over low molecular weight heparin (LMWH) and LMWH over unfractionated heparin (heparin) for the initial treatment of VTE. Limited evidence is available about the patterns of anticoagulant treatment for VTE in routine clinical practice of large healthcare delivery networks in the United States (US) and whether the VTE treatments are aligned with current guidelines. This study aimed to assess real-world anticoagulant treatment patterns among VTE patients using harmonized electronic health record (EHR) data from four Integrated Delivery Networks (IDNs) in the US. Methods: This was a retrospective, longitudinal, multicenter, cohort study using harmonized EHR data from both inpatient and outpatient settings. The study population included adult patients prescribed DOACs, warfarin, and/or PAC therapy as inpatient or outpatient treatment within ≤30 days of VTE diagnosis, between June 2015 through May 2018. Data from the four IDNs was pooled to describe demographic characteristics and treatment patterns among VTE patients overall and by subgroups. Results: A total of 10,527 patients who were treated with OACs after VTE diagnosis were included for analysis. The mean (SD) age was 61.9 (5.98) years, with 46.1% aged 65 or older. More than half (53.2%) were female, and White patients comprised the majority (74.4%), followed by African American patients (22.8%). Obese and morbidly obese patients comprised 39.1% and 16.1% of patients, respectively. Among all VTE patients, warfarin-only (n=3545; 33.7%) was the most commonly used OAC treatment, followed by warfarin + PAC (n=3128; 29.7%), rivaroxaban-only (n=1357; 12.9%), rivaroxaban + PAC (n=853; 8.1%), apixaban + PAC (n=839; 8.0%), apixaban-only (n=762; 7.2%), and Other OAC (n=357; 3.4%) (Table 1). When stratifying VTE patients by age, gender, race and BMI, some variations in OAC treatment were observed. Among both older (≥65 years) and younger ( Patterns of anticoagulant treatments including OACs and/or parental anticoagulants among VTE patients with cancer were further analyzed (Figure 1). Among VTE patients with cancer (n=3657), heparin had the highest use (26.7%), then enoxaparin (22.7%); approximately the same proportion of cancer patients received warfarin-only (16.0%) and warfarin + PAC (16.9%). Of DOACs, rivaroxaban-only was the most commonly used treatment (4.9%), then apixaban + PAC (3.5%), and lastly, rivaroxaban + PAC (3.4%) among cancer patients. Conclusion: Current VTE treatment guidelines recommend warfarin to be bridged with PAC, however, warfarin-only therapy remained the most used treatment option followed by warfarin + PAC. While rivaroxaban and apixaban are not required to be bridged with PAC, such practices were observed for a large proportion of apixaban- and rivaroxaban-treated VTE patients. VTE treatment among patients with cancer was not completely aligned with current guidelines, as heparin was more commonly used than LMWH (enoxaparin). Our findings suggest greater efforts are needed to improve anticoagulant treatment practices among VTE patients. Figure 1 Figure 1. Disclosures Dhamane: Bristol Myers Squibb: Current Employment, Current equity holder in publicly-traded company. Rosenblatt: Bristol Myers Squibb: Current Employment, Current equity holder in publicly-traded company. Jiang: Bristol Myers Squibb: Current Employment, Current equity holder in publicly-traded company. Guo: Bristol Myers Squibb: Ended employment in the past 24 months. Dorsch: Agency for Health Research and Quality: Research Funding; National Institutes of Health/National Institute of Aging: Research Funding; American Health Association Health IT Research Network: Research Funding; Janssen Pharmaceuticals: Honoraria; Bristol Myers Squibb/Pfizer: Research Funding; Amgen: Research Funding. Luo: Pfizer Inc: Current Employment, Current equity holder in publicly-traded company.

Introduction Pharmacotherapy of overactive bladder (OAB) typically involves treatment with an antimuscarinic or mirabegron, a β3-adrenoceptor agonist, but real-world evidence on their use, including treatment access, persistence, and switching, is limited. Here, we describe the design of a prospective, multicenter, non-interventional registry of patients beginning a new course of OAB pharmacological therapy in routine clinical practice. Methods Adults with an OAB diagnosis for at least 3 months who either initiated a new course of mirabegron or antimuscarinic, or who switched therapy were enrolled into PERSPECTIVE (a P rospective, non-int E rventional R egistry S tudy of P ati E nts initiating a C ourse of drug T herapy for overact IVE bladder). The primary objective was to identify factors associated with improved OAB treatment effectiveness from a patient perspective. Secondary objectives were to compare persistence rates, reasons for discontinuation, and switching patterns between patients taking mirabegron or antimuscarinics. Healthcare centers and sites involving medical specialties who routinely participate in the care and treatment of patients with OAB (e.g., gynecology, urology, and primary care practices) were targeted for recruitment. Patient-reported outcomes (PROs), including quality of life, symptom bother, and treatment satisfaction from OAB-validated scales, were collected at baseline, months 1, 3, 6, and 12, and when patients switched or discontinued their current OAB medication. Conclusions PERSPECTIVE is the first real-world observational study in the United States and Canada on clinical and patient perspectives in OAB management. Recruitment was reflective of centers where patients are treated for OAB to maximize generalizability to the real-world population. Trial registration: ClinicalTrials.gov , ID number NCT02386072 (date of registration March 6, 2015).

Objective To determine the differences in attitudes and other determinants of care-seeking behavior between persons who have used chiropractic services and persons who have not. A second objective is to determine the interest in members of these 2 groups in choosing nonmedical doctors for providing routine services. Methods In 1998, a nationwide telephone survey of randomly selected households in the United States was done, including 400 adults who have used chiropractic services and 400 adults who have not. Survey participants were asked about their use, knowledge, and attitudes about chiropractic care, attitudes about personal role in health care, current source of obtaining usual and routine care, and willingness to consider use of nonmedical doctors as the usual source of such care. The analysis compares persons who have used with those who have not used chiropractic services by using a χ2 test to determine significance of differences between the responses of the 2 groups. A multivariate analysis is done of willingness to use alternative providers for routine care. Results Persons who have seen a doctor of chiropractic before have different attitudes and preferences about health and health care than others who have never seen a doctor of chiropractic. Almost all of persons in both groups have medical doctors that they use for routine care, and a sizeable portion of both groups would be willing to consider using a nonmedical doctor for this role. Although willingness to use a chiropractor in this role is much higher among persons who have used a chiropractor before, both groups would prefer physician assistants and nurse practitioners to chiropractors in this role. Conclusion For persons participating in this survey, unwillingness to accept the idea of a chiropractor in a primary care role may be largely due to poor knowledge about chiropractic care.

Skin disease is one of the top 15 groups of medical conditions for which prevalence and health care spending increased the most between 1987 and 2000, with approximately 1 of 3 people in the United States with a skin disease at any given time. Even so, a national data profile on skin disease has not been conducted since the late 1970s. This study closes the gap by estimating the prevalence, economic burden, and impact on quality of life for 22 leading categories of skin disease. The estimated annual cost of skin disease in 2004 was 39.3 billion dollars, including 29.1 billion dollars in direct medical costs (costs of health services and products) and 10.2 billion dollars in lost productivity costs (defined as costs related to consumption of medical care, costs associated with impaired ability to work, and lost future earning potential because of premature death). Based on a methodology of willingness to pay for symptom relief, the additional economic burden of skin disease on quality of life amounted to an estimated 56.2 billion dollars. Including the economic burden on quality of life, the total economic burden of skin disease to the US public in 2004 was approximately 96 billion dollars.

Objective: To examine the feasibility of broader and more frequent primary care roles for chiropractors. Data Collection: Literature review and analysis of existing databases. Six types of barriers were examined, including legal, financial, professional, accessibility or geographic location, consumer preference, and self-imposed barriers. Results: Although research into the barriers of an expanded primary care role for chiropractors is inconclusive, several inferences can be drawn from this analysis. First, prevailing state practice acts preclude only a limited number of activities that are necessary for chiropractors to serve in a primary care capacity. The self-perception by a portion of the chiropractic profession that as neuromusculoskeletal system specialists, they are either uninterested or ill-prepared for providing primary care serves as a second barrier. Third, payment provisions that do not permit chiropractors to be reimbursed for primary care services significantly limit their ability to expand primary care capacity. Fourth, consumer perceptions of chiropractors as neuromusculoskeletal system specialists are a persistent barrier to expanding status. Given the current importance of managed care, the fifth and most crucial barrier for chiropractic may be managed care organizations' lack of interest in having chiropractors in primary care roles. Conclusion: Research on the barriers to a more expanded primary care role for chiropractors is incomplete. The available research helps little in ruling out plausible barriers that might make it possible to narrow the scope of subsequent research. (J Manipulative Physiol Ther 2002;25:427-49)

To meet the challenge of an aging population, providers andpayors must optimize chronic wound care outcomes and contain costs. To explore the costs, outcomes, and effects of outcomes on costs of pressure and venous ulcer woundcare protocols. Modeling study using outcomes from a literature review. The cost of 12 weeks of wound care was modeled for a hypothetical managed-care plan. This included 100 000 covered lives and used a peer-validated wound care protocol. Only modalities with a pooled evidence base of at least 100 wounds were used to populate the model. Costs excluded supportive treatments. 26 studies of three pressure ulcer protocols (n = 519) and three venous ulcer protocols (n = 883) qualified for inclusion in the models. After 12 weeks, the weighted average proportion of ulcers healed, and cost per ulcer healed, ranged from 48 to 61% and from $US910 to $US2179 (2000 values) for pressure ulcers, and from 39 to 51% and $US1873 to $US15 053 for venous ulcers. For a hypothetical managed-care plan, the difference between the least and most cost-effective modalities was $US1.9 million for pressure ulcers and $US5.8 million for venous ulcers. Observed differences were generally attributable to variances in outcomes and cost differences related to frequency of dressing changes. Pressure ulcer care takes place in inpatient care settings; venous ulcers are managed on an outpatient basis. Physician visit frequencies are once every four weeks for pressure ulcers and once each week for venous ulcers. Wound sizes ranged from 2.5cm2 to 5.6cm2 for pressure ulcers and 5.4cm2 to 10cm2 for venous ulcers. All patients with pressure ulcers required pressure relief, nutritional support and incontinence management; venous ulcers required gradient compression. Costs per patient healed were lowest for pressure ulcers with hydrocolloids and highest with saline gauze (this is a manpower issue). Costs to heal venous ulcers were highest with human skin construct and lowest for 12-week management with hydrocolloid. Despite the limitations of the models (as a result of incomplete study data), this analysis confirms that defining wound care costs solely as cost of products used is inaccurate and can be expensive.