Patient- and Clinician-Reported Outcomes for Tirbanibulin in Actinic Keratosis in Clinical Practice Across the United States (PROAK).

BACKGROUND: The Patient-Reported Outcomes in Actinic Keratosis (PROAK) study evaluated patient- and clinician-reported outcomes (PRO; ClinRO) during 24 weeks of follow-up among adult patients with actinic keratosis (AK) on the face or scalp who were administered tirbanibulin 1% ointment in real-world community practices in the United States.  Methods: Quality of life (QoL) was assessed by Skindex-16 at week (W) 8. Additionally, effectiveness (Investigator Global Assessment [IGA]), PRO and ClinRO (Treatment Satisfaction Questionnaire for Medication and Expert Panel Questionnaire), safety, and tolerability were assessed at W8 and W24. RESULTS: The safety population included 300 patients; the full analysis set included 290 patients (278 patients at W24). At W8, a statistically significant difference (P<0.03) was observed for Skindex-16 domains in all assessed subgroups. Clinicians and patients reported high global satisfaction (mean [SD] scores of 74.9 [23.9] and 72.0 [24.6], respectively) at W24. Overall skin appearance improved from baseline to W24 (83.6% clinicians; 78.5% patients). IGA success (IGA score of 0-1) was achieved by 71.9% of patients at W24 with a similar % at W8 (73.8%) suggesting a stable effectiveness over time. About 5% of patients reported at least one adverse event, 4% reported at least one serious adverse event and no patients reported serious adverse drug reactions. At W8, the most frequently reported local skin reactions were mild/moderate erythema (47.6%) and flaking/scaling (49.6%). CONCLUSIONS: Treatment with tirbanibulin demonstrated effectiveness in the management of AK lesions and a favorable safety and tolerability profile. Furthermore, QoL was improved as early as W8, and both patients and clinicians reported high levels of treatment satisfaction, independently of patients' characteristics. J Drugs Dermatol. 2024;23(5):338-346. doi:10.36849/JDD.8264.

INDIVIDUAL ARTICLE: Impact of Acne Vulgaris and Sarecycline on Social/Emotional Functioning and Daily Activities: PROSES Study.

BACKGROUND: Concise patient-reported outcome (PRO) instruments addressing the consequences of facial acne vulgaris (AV) on patients’ functioning and activities of daily living (ADL) are needed. METHODS: A 12-week, single-arm, prospective cohort study was conducted in patients ≥9 years old with moderate/severe non-nodular facial AV prescribed sarecycline as part of usual care. The primary endpoint included AV-specific patient- and caregiver-reported outcomes assessed with the expert panel questionnaire (EPQ, developed by 10 experts using a Delphi method) in patients (>12 years) and caregivers (for patients 9-11 years). Additional assessments included parental/caregiver perspectives on children’s AV. RESULTS: A total of 253 patients completed the study. Following 12-weeks of treatment, there were significant (P ≤.0001) changes from baseline in the proportion of patients responding that they never or rarely: felt angry (31.6%), worried about AV worsening (28.9%), had thoughts about AV (20.9%), had a certain level of worries about AV (38.7%), altered their social media/selfie activity (23.7%), had an impact on real-life plans due to AV (22.9%), made efforts to hide AV (21.3%), felt picked-on/judged due to AV (15.0%), were concerned about their ability to reach future goals due to AV (13.8%), or had sleep impacted due to AV (18.2%). No significant change from baseline was observed for parent/caregiver’s understanding of the child’s AV concerns, from both patient and parent/caregiver perspectives. CONCLUSIONS: Over 12 weeks of AV management with oral sarecycline, patients reported significant reductions in AV-related effects on emotional/social functioning and ADL as measured by the EPQ, a simple PRO with potential for use in clinical practice. J Drugs Dermatol. 2024;23:1(Suppl 1):s4-11.

INDIVIDUAL ARTICLE: Sarecycline Improves Acne Severity, Symptoms, and Psychosocial Burden in Non-nodular Acne Vulgaris: PROSES Study.

BACKGROUND: Patient-reported outcomes (PROs) are emerging as a fundamental component of disease impact assessment in acne vulgaris (AV), complementing clinician-reported outcomes. No data is available on PROs for patients with AV using sarecycline in real-world settings. METHODS: A single-arm, prospective cohort study that included patients ≥9 years old diagnosed with moderate or severe non-nodular AV was implemented as part of routine care in clinical practices (N=30). Patients received oral sarecycline (60 mg, 100 mg, or 150 mg) for 12 weeks, as part of usual care. The primary endpoint was Acne Symptom and Impact Scale (ASIS) responses from patients (≥12 years) and caregivers (for patients 9-11 years) at week 12 and change from baseline (CFB). Investigator’s Global Assessment (IGA) of AV severity and adverse events (AEs) were also recorded. RESULTS: A total of 253 patients with AV completed the study (adults: 60.1%, females: 77.6%). ASIS mean scores significantly decreased (P <.0001) at week 12 for: signs (mean CFB ± standard deviation [SD]: –0.8 ± 0.7), impact (–1.0 ± 1.0), emotional impact (–1.2 ± 1.1), and social impact (0.6 ± 1.1). Significant reductions in AV severity (P <.0001) were reported by patients and caregivers. The IGA success rate was 58.9% and physician satisfaction with treatment outcomes was 88.1%. A total of 31 (10.3%) patients reported ≥1 AE during the study. CONCLUSIONS: Patients with moderate-to-severe AV receiving acne management with an oral antibiotic for 12 weeks experienced a significant improvement in AV-related symptoms and psychosocial burden. J Drugs Dermatol. 2024;23:1(Suppl 1):s12-18.

Patient-reported outcomes in patients with cystic fibrosis with a G551D mutation on ivacaftor treatment: results from a cross-sectional study.

BACKGROUND: Clinical studies demonstrate that ivacaftor (IVA) improves health-related quality of life (HRQoL) in patients aged ≥6 years with cystic fibrosis (CF). The real-world impact of IVA and standard of care (SOC) in groups of patients with G551D and F508del mutations, respectively, was assessed using a survey comprising disease-specific and generic HRQoL measures. METHODS: Patients with CF aged ≥12 years, or aged 6-11 years with caregiver support, with either (1) a G551D mutation and receiving IVA (G551D/IVA) for ≥3 months, or (2) homozygous for F508del and receiving SOC before lumacaftor/IVA availability (F508del/SOC), were eligible to participate in a cross-sectional survey. Demographic and clinical characteristics, and HRQoL measures were compared between patient groups, and multiple regression analyses were conducted. RESULTS: After differences in patient demographic and clinical characteristics were controlled for, significantly better scores were observed in the G551D/IVA group than in the F508del/SOC group on multiple domains of the validated Cystic Fibrosis Questionnaire-Revised and the EuroQol 5-dimensions 5-level questionnaire. CONCLUSIONS: G551D/IVA patients reported better HRQoL than F508del/SOC patients on generic and disease-specific measures in a real-world setting.

Deflazacort versus prednisone/prednisolone for maintaining motor function and delaying loss of ambulation: A post HOC analysis from the ACT DMD trial.

INTRODUCTION: ACT DMD was a 48-week trial of ataluren for nonsense mutation Duchenne muscular dystrophy (nmDMD). Patients received corticosteroids for ≥6 months at entry and stable regimens throughout study. This post hoc analysis compares efficacy and safety for deflazacort and prednisone/prednisolone in the placebo arm. METHODS: Patients received deflazacort (n = 53) or prednisone/prednisolone (n = 61). Endpoints included change from baseline in 6-minute walk distance (6MWD), timed function tests, estimated age at loss of ambulation (extrapolated from 6MWD). RESULTS: Mean changes in 6MWD were -39.0 m (deflazacort; 95% confidence limit [CL], -68.85, -9.17) and -70.6 m (prednisone/prednisolone; 95% CL, -97.16, -44.02). Mean changes in 4-stair climb were 3.79 s (deflazacort; 95% CL, 1.54, 6.03) and 6.67 s (prednisone/prednisolone; 95% CL, 4.69, 8.64). CONCLUSIONS: This analysis, limited by its post hoc nature, suggests greater preservation of 6MWD and 4-stair climb with deflazacort vs. prednisone/prednisolone. A head-to-head comparison will better define these differences. Muscle Nerve 58: 639-645, 2018.

Family caregivers' facilitation of daily adult prescription medication use.

OBJECTIVE: To describe ways family members assist adult patients with prescription medications at home, during medical visits and at the pharmacy. METHODS: Online survey of 400 adults (caregivers) who help another adult (care recipient) with prescription medication use. Regression modeled the contribution of caregiver communication during recipients' medical visits, evaluation of physicians' medication communication and discussions with the dispensing pharmacist on caregivers' assistance with home medication management. RESULTS: Female (68%) family members (94%) assisted care recipients with multimorbidity (mean 2.9 conditions) and polypharmacy (mean 3.2 prescriptions). On average, caregivers performed 3 visit communication behaviors (e.g., notetaking) and implemented 2.6 home medication management strategies (e.g., filling/monitoring pill boxes). Communication-related variables explained 17% of home medication management assistance; including caregivers' visit communication (std. beta 0.31), physicians' medication communication (std. beta 0.15) and pharmacist discussions (std. beta 0.10). The final model included recipients' multimorbidity and caregiver education (std. betas 0.21 and 0.13) explaining 22% of caregiver assistance with home medication management. CONCLUSION: Caregivers' assistance with safe and effective home medication use crosses care contexts and is facilitated by clinician and pharmacist communication. PRACTICE IMPLICATIONS: Support for caregiver engagement in healthcare conversations can contribute to patient adherence and family-centered, high quality care.

Adherence to therapies in cystic fibrosis: a targeted literature review.

INTRODUCTION: Cystic fibrosis (CF) is a life-shortening condition with no cure. Available therapies relieving the symptoms of CF are complex and time-consuming. A comprehensive review assessing adherence to different CF therapies, association of adherence with outcomes, and factors influencing adherence could inform optimal patient management strategies. Areas covered: A targeted literature review of studies published from 2010-2016 assessed adherence to CF therapies. Nineteen studies qualified for inclusion. Adherence to CF therapies was sub-optimal, and varied by treatment, mode of treatment administration, age, season, time and method of adherence measurement. Adherence to ivacaftor and inhaled antibiotics were reported higher than dornase alfa or hypertonic saline, oral pancreatic enzyme and vitamin supplements, and airway clearance therapy. Several patient, healthcare provider and treatment related factors influenced adherence. Sub-optimal adherence was shown to impact clinical and economic burden of the disease. Expert commentary: Higher adherence to CF therapies can lower disease burden, and improve patient outcomes. Healthcare providers and policy makers should devise patient-centered and caregiver-enabled interventions to improve adherence. Research on long-term adherence and outcomes associated with promising oral treatments such as CFTR modulators is needed. Identifying ways to overcome key barriers to adherence can positively affect outcomes associated with CF.

Health-Related Quality of Life in Patients with Metastatic Pancreatic Cancer.

PURPOSE: Due to its clinical course and often-late detection, many patients with metastatic pancreatic cancer (mPC) experience poor quality of life (QoL). This pilot project assessed real-world QoL in patients with mPC at different stages of treatment. METHODS: A cross-sectional survey was conducted in the following groups of patients with mPC: before initiation of first-line (1L) chemotherapy (no treatment); with partial response (PR) or stable disease (SD) upon receipt of ≥3 cycles of 1L nab-paclitaxel plus gemcitabine (nab-paclitaxel plus gemcitabine PR or SD); and with disease progression during ≥1L chemotherapy and not currently receiving nab-paclitaxel (≥1L PD). Eligible participants completed three QoL instruments, EORTC QLQ-C30, the pancreatic cancer module of EORTC QLQ-PAN26, and the EQ-5D, during their clinical visits at 14 clinics across the USA. RESULTS: Demographic characteristics were similar among groups (no treatment, n = 29; nab-paclitaxel plus gemcitabine PR or SD, n = 26; ≥1L PD, n = 17). Patients in the nab-paclitaxel plus gemcitabine PR or SD group had lower mean pain scores by EORTC-QLQ-C30 (27.6 vs 47.1; P = 0.02) and lower mean pancreatic pain scores by EORTC-QLQ-PAN26 (27.9 vs 45.4; P = 0.02) compared with the no treatment group. The groups did not differ significantly in QoL as measured by the EQ-5D. CONCLUSIONS: Patients who experienced PR or SD with 1L nab-paclitaxel plus gemcitabine had improved general and pancreatic pain scores and no clinically meaningful deterioration in QoL compared with patients who had not yet initiated chemotherapy.

Oncologist Support for Consolidated Payments for Cancer Care Management in the United States.

BACKGROUND: The cost of cancer care in the United States continues to rise, with pressure on oncologists to provide high-quality, cost-effective care while maintaining the financial stability of their practice. Existing payment models do not typically reward care coordination or quality of care. In May 2014, the American Society of Clinical Oncology (ASCO) released a payment reform proposal (revised in May 2015) that includes a new payment structure for quality-of-care performance metrics. OBJECTIVES: To assess US oncologists' perspectives on and support for ASCO's payment reform proposal, and to determine use of quality-of-care metrics, factors influencing their perception of value of new cancer drugs, the influence of cost on treatment decisions, and the perceptions of the reimbursement climate in the country. METHODS: Physicians and medical directors specializing in oncology in the United States practicing for at least 2 years and managing at least 20 patients with cancer were randomly invited, from an online physician panel, to participate in an anonymous, cross-sectional, 15-minute online survey conducted between July and November 2014. The survey assessed physicians' level of support for the payment reform, use of quality-of-care metrics, factors influencing their perception of the value of a new cancer drug, the impact of cost on treatment decision-making, and their perceptions of the overall reimbursement climate. Descriptive statistics (chi-square tests and t-tests for discrete and continuous variables, respectively) were used to analyze the data. Logistic regression models were constructed to evaluate the main payment models described in the payment reform proposal. RESULTS: Of the 231 physicians and medical directors who participated in this study, approximately 50% strongly or somewhat supported the proposed payment reform. Stronger support was seen among survey respondents who were male, who rated the overall reimbursement climate as excellent/good, who have a contract with a commercial payer that reimburses for dispensed oral cancer drugs, or who practice in a hospital setting. The use of at least 1 quality-of-care metric was more common among respondents participating in an accountable care organization (ACO) than among those not participating in an ACO (92.6% vs 83.2%, respectively; P = .0380). The most common metric used by the physicians in their practice setting was patient satisfaction scores (60.1%). Accountability for delivering high-quality care was supported by 74.9% of respondents; those who practice in a hospital setting were twice as likely as those in private practice to support accountability for quality of care (81.3% vs 67.6%; odds ratio, 2.1; P = .0176). CONCLUSION: Support for ASCO's payment reform proposal is mixed among oncology physicians and medical directors, underscoring the importance of continuous and broader engagement of practicing physicians around the country via outreach and dialogue on topics that impact their clinical practices, as well as providing education or awareness activities by ASCO to its membership.

Demonstrating the value of medicines: evolution of value equation and stakeholder perception of uncertainties.

It is important to evaluate how the value of medicine is assessed, as it may have important implications for health technology and reimbursement assessments. The value equation could comprise 'incremental benefit/outcome' (relative results of care in terms of patient health, comparing the innovation to best available alternative(s)) in the numerator and 'cost' (relative costs involved in the full cycle of care (or a defined period) for the patient's medical condition, incorporating the relevant cost-offsets due to displacement of best available alternative(s)) in the denominator. This 'relative value' combined with the overall net budget impact (of including the drug in the formulary or reimbursed drug list) at the concerned population level in the given institution/region/country may better inform the usefulness of the new therapeutic option to the healthcare system. As product value messages are created, anticipating external stakeholder questions and information needs, including addressing three main categories of 'uncertainties', namely the scientific uncertainties, usage uncertainties, and financial uncertainties, could facilitate demonstration of optimal product value and help informed decision-making to benefit all stakeholders involved in the process.

Disease burden and patient reported outcomes among patients with moderate to severe psoriasis: an ethnography study.

OBJECTIVES: To assess the impact of psoriasis on health-related quality of life (HRQoL). METHODS: An ethnographic study of patients with moderate to severe psoriasis was conducted in the US, France, Germany, Italy, Spain, UK, Brazil, and Canada to explore patients' views on treatment and the impact of psoriasis on HRQoL. Anthropologists and ethnographers spent a minimum of 5.5 hours with each consented patient and filmed their behaviors in everyday situations. Visual data and notes were analyzed to identify HRQoL-related themes. RESULTS: The study included 50 adult patients. Patients described their appearance with disgust and self-loathing. Frustration was expressed due to a perceived lack of control of their lives. Prior to initiation of biologic treatment, daily rituals absorbed a good part of their day, including applying creams, checking one's appearance, and covering the body. Due to a lack of cultural discourse and patient's difficulty in articulating the impact of psoriasis, partners and family did not know how to react nor did they realize the full extent of the problem, and many patients experienced perceived social discrimination due to psoriasis, leaving them with feelings of isolation. Patients established on biologic treatment noticed a significant physical improvement and regained confidence, but psychosocial impacts, including social isolation, remained. CONCLUSION: This ethnographic study vividly depicted the unarticulated and emotional impact of psoriasis on the everyday lives of patients and presents an effective method of assessing HRQoL in chronic diseases.

Economic burden of systemic lupus erythematosus flares and comorbidities in a commercially insured population in the United States.

OBJECTIVE: To estimate the medical and productivity-related cost burden of systemic lupus erythematosus (SLE) flares and comorbidities in a commercially insured population. METHODS: Using administrative data, annual medical costs and indirect costs because of work loss were calculated for adult SLE patients, including flare severity and SLE-related comorbidity subsets, and a matched control group without SLE. RESULTS: Adjusted annualized medical costs were $18,952, $4305, $914, and $441 greater for SLE patients with severe, moderate, mild, and no flares, respectively, during follow-up than those of the matched controls. Medical costs also varied by SLE-related comorbidity. Adjusted annualized indirect costs of work loss because of absence and short-term disability were $1867 and $1602 greater, respectively, for SLE patients than for controls. CONCLUSIONS: SLE imposes a substantial cost burden to both patients and their employers.

A longitudinal analysis of costs associated with change in disease activity in systemic lupus erythematosus.

OBJECTIVES: To estimate the economic consequences of changes in disease activity on healthcare resource utilization (HRU) and costs. METHODS: A retrospective longitudinal study of systemic lupus erythematosus (SLE) patients receiving care in a regional integrated health delivery system in the US from 01/2004 through 03/2011 was conducted using electronic health records, medical chart reviews, and claims. Eligible patients were ≥18 years old, with ≥1 rheumatologist-confirmed SLE diagnosis and ≥1 eligible rheumatology encounter. Patients were continuously enrolled ≥90 days before and ≥30 days after the encounters. Charts were manually reviewed to estimate SLEDAI scores. Average unit costs of each medical procedure, facility use, and prescription were estimated from a payer perspective (2011 USD) using a managed care claims database. HRU and costs were calculated for the 30-day period surrounding every SLEDAI score date (10 days before and 19 after). Relationships between HRU/costs and SLEDAI scores were estimated using mixed-effect models. RESULTS: Overall, 178 SLE patients were included; mean age was 50.6 years, 91% were female, and 95.5% Caucasian. Patients had a total of 1343 encounters with SLEDAI scores over an average period of 1035 days. Reductions of SLEDAI scores were associated with reductions in HRU and costs. SLEDAI score reductions of 4-points were associated with reductions of 10% HRU and 14% costs over a 30-day period; reductions of 8-points had associated reductions of 19% HRU and 26% costs; and reductions of 10-points had associated reductions of 23% HRU and 31% costs. Annualized, changes in SLEDAI scores are associated with changes of $2485 (SLEDAI score change: 10-6), $4624 (10-2), and $5579 (10-0), respectively. CONCLUSION: Reductions in disease activity were associated with substantial reductions of HRU and costs. LIMITATIONS: Only short-term effects of disease activity change were investigated, disregarding other potential benefits of low disease activity on long-term organ damage prevention or comorbidities.

Economic burden of herpes zoster among skilled nursing facility residents in the United States.

OBJECTIVES: To evaluate health care resource use and direct medical costs attributable to herpes zoster (HZ) among elderly residents of skilled nursing facilities (SNF). METHODS: This was a retrospective matched cohort study using data from 300 SNF in the United States. A total of 404 patients with HZ were matched with 1616 patients with no documented HZ or post-herpetic neuralgia using propensity scores. The study period included a 1-month pre-index period and the 90-day acute/subacute phase following the HZ index date. Health care resource utilization was captured from the long term care minimum dataset (MDS) and SNF admission-discharge records. The direct medical costs consisted of the SNF net bed revenue and hospitalization cost. RESULTS: Over the 4-month study period, significantly more patients were hospitalized among the HZ (20.5%) than non-HZ cohort (14.4%). Both the numbers of hospitalization episodes and hospitalization days were greater for HZ than for non-HZ patients. An average additional 0.09 hospitalization episodes and 0.55 days of hospitalization were estimated in a multivariate model for patients in the HZ compared with the non-HZ cohort. The incremental direct medical costs, which are composed of the incremental medical costs incurred in the SNF, and the incremental costs attributable to hospitalization, were estimated between $1079 and $1673 for patients with HZ. CONCLUSION: In the SNF setting, the presence of HZ imposes significant health care resource utilization and direct medical costs.

Fall-related hospitalization and facility costs among residents of institutions providing long-term care.

PURPOSE: The purpose of this study was to estimate hospital and long-term-care costs resulting from falls in long-term-care facilities (LTCFs). DESIGN AND METHODS: The study used a retrospective, pre/post with comparison group design. We used matching, based on propensity scores, to control for baseline differences between fallers and non-fallers. We estimated residents' propensity to fall from demographics, comorbidities, and reimbursement in the pre-period. The matched sample included 1,130 fallers and 1,130 non-fallers who were residents of a large, multifacility long-term-care chain. Cost estimates were based on information in the Minimum Data Set and were defined as hospital and LTCF reimbursements. We estimated fall-related costs as the difference between changes in costs for fallers and non-fallers from the pre- to post-period. RESULTS: Fallers were substantially more likely to suffer fractures and hospitalizations in the post-period than were non-fallers. Fall-related LTCF and hospital costs were $6,259 (95% confidence interval = $2,034-$10,484) per resident per year. About 60% of this amount was attributable to higher hospitalization costs. Fallers were more likely to be discharged to hospitals or to die. IMPLICATIONS: Falls in LTCFs are associated with costs of about $6,200 per resident per year. These results provide baseline estimates that one may use to estimate the cost-effectiveness of interventions to reduce fall rates.

Factors influencing the acceptance of changes in antiretroviral therapy among HIV-1-infected patients.

Physicians routinely consider modifying antiretroviral therapy (ART) regimen for their patients with HIV. Little is known about the factors associated with patients' willingness to accept providers' recommended ART changes. This multicenter prospective observational study examined factors associated with willingness to accept ART changes recommended by their providers among HIV-infected adults from six urban outpatient HIV clinics. Patients were surveyed using the Patient Attitudes about Altering Antiretroviral Therapy Survey questionnaire (PAAARTS). Factors associated with willingness to accept ART changes were assessed using a multivariate generalized estimating equation (GEE) model to account for correlated responses. The Classification and Regression Trees (CART) analysis was also performed to determine subgroups of patients with higher acceptance of change. 216 of 289 patients (75%) definitely accepted recommended changes. Odds for acceptance were 3.2, 2.3, and 2.8 times higher for patients with higher attitudes and beliefs about ART (p < 0.01; 95% confidence interval [CI] = 1.59, 6.52), patients who rated their provider's care as excellent (p < 0.05; 95% CI = 1.07, 4.78), and non-Hispanic patients (p < 0.05; 95% CI 1.03, 7.57), respectively. CART analysis showed similar results and identified that when patients had less positive attitude about ART, acceptance rates were higher for non-Hispanic patients with higher assessments of their patient-provider communication. While most patients accepted providers' recommendation for ART changes, this willingness was influenced by both patients' attitudes and beliefs about ART and their assessment of either the effectiveness of patient-provider communication or their rating of providers' care. ART acceptance rates among Hispanic patients were lower.

Is drug therapy for urinary incontinence used optimally in long-term care facilities?

OBJECTIVES: To examine the management of urinary incontinence (UI) among nursing home (NH) residents in the United States, particularly drug therapy for UI in those who may be suitable candidates for such treatment based on their functional status. DESIGN: Retrospective analysis of admissions (between January 2, 2002, and December 31, 2003) to a total of 373 skilled nursing facilities and assisted living centers operated by a single provider of long-term care. PARTICIPANTS: Residents identified as incontinent according to at least one Minimum Data Set (MDS) assessment during their NH stay who had adequate mobility and/or cognitive ability to toilet, as determined by a toileting score of < or =2 on the 5-point MDS scale, and/or a score of < or =3 on the 7-point scale, the Cognitive Performance Score (CPS). MEASUREMENTS: MDS assessments for individual residents were obtained from a central database linked to a physician order database that captured the dose, frequency, and start and stop dates of all medications prescribed. Residents were stratified into treated or untreated groups according to whether or not they were prescribed medications used to treat UI (including tolterodine, oxybutynin [oral and transdermal patch formulations], desmopressin, and flavoxate). RESULTS: During the study period, there were 58,216 admissions to the 373 participating facilities; 31,219 (54%) were identified as incontinent of urine on the MDS. The study population comprised 25,140 NH residents who met MDS criteria for UI (80.5% of the total identified as incontinent of urine) and who had adequate mobility to toilet and/or did not have severe cognitive impairment. They were typically over 60 years of age (95.2%), female (65.1%), and frequently or completely incontinent (63.1%). Nonpharmacologic treatment (as recorded in the MDS) included pads/briefs (76.8%), scheduled toileting (31.9%), and/or bladder retraining (2.8%). Only 1752 (7.0%) of eligible residents received medication for their UI. Using a multivariate analysis, factors that were significantly associated with drug treatment for UI included female gender, frequent or complete urinary incontinence (MDS category 3-4), constipation, and use of incontinence appliances/programs and walking aids. Older residents and those with severe cognitive impairment were less likely to receive drug therapy. CONCLUSIONS: Only a small proportion of incontinent NH residents with mobility and cognitive function potentially suitable for specific treatment for incontinence receives drug therapy for their condition. Further research is needed to determine whether low drug use reflects an unmet need for treating UI, or appropriate prescribing practices based on the multiple and interacting factors that influence decisions on drug therapy in the NH population.

Antipsychotic drug use among nursing home residents taking rivastigmine.

OBJECTIVE: To evaluate whether or not rivastigmine use is associated with a decrease in the initiation of antipsychotic drug therapy among nursing home residents in the United States. METHODS: A retrospective analysis was performed using Minimum Data Set data and physician order files for newly admitted residents of 452 US nursing facilities from 2000 through 2002. The rivastigmine group included those who were diagnosed with Alzheimers disease (AD) and began rivastigmine treatment within 30 days of diagnosis. Patients were required to be on treatment for a minimum of 30 days. The control group included those who were diagnosed with AD, but did not receive a cholinesterase inhibitor. All subjects were antipsychotic drug-naive within 30 days of baseline (initiation of rivastigmine or initial AD diagnosis). A Cox proportional hazards model was used to estimate predicted risk of antipsychotic drug use. RESULTS: This study included 845 patients in the rivastigmine group and 517 patients in the control group. The rivastigmine group had fewer female patients, was younger, and had more verbal distress, sleep issues, sadness, loss of interest, and behavioral symptoms at baseline compared with the control group (P < .01). Overall initiation of antipsychotics was lower in the rivastigmine group (8.6%) compared with the control group (17.0%). Patients in the control group were almost 2 times more likely (relative risk = 1.86; P < .001) to take antipsychotics compared with patients taking rivastigmine, after adjusting for demographic covariates and mental health conditions or behavioral symptoms at baseline. Patients with baseline mental health conditions or behavioral symptoms were more likely to start antipsychotics than those without such conditions (P < .001). CONCLUSIONS: Study results suggest that nursing home residents with Alzheimers disease treated with rivastigmine have a reduced risk of initiating therapy with an antipsychotic drug compared with residents who do not receive cholinesterase inhibitor treatment.

Urinary incontinence in the nursing home: resident characteristics and prevalence of drug treatment.

OBJECTIVES: To provide a descriptive overview of the elderly, nursing home patient population with urinary incontinence (UI). METHODS: This study was a descriptive, cross-sectional database analysis (2002-2003) examining UI prevalence, demographic and clinical characteristics of UI patients, and UI pharmacotherapy prevalence in the nursing home setting. RESULTS: Of the 29 645 eligible subjects, 8995 experienced some level of UI at the time the minimum data set (MDS) was completed (30%). Compared with continent residents, a greater percentage of incontinent residents were older, white women and had a longer length of stay. Incontinent residents also had more indicators of frailty than those who were continent; they were more impaired on activities of daily living and cognitive performance scale scores, were hospitalized more frequently, and had more urinary tract infections, pressure ulcers, and depression. More incontinent residents were using pads/briefs and had bladder retraining and scheduled toileting. Only 8.7% of those residents rated as having the most severe level of incontinence (MDS level 4) were being treated with pharmacotherapy. Of the 8995 residents with a UI rating of 1 to 4, only 8% (n = 731) had pharmacotherapy. CONCLUSION: There is a high prevalence of UI among nursing home residents and having this condition is negatively correlated with measures of resident health status and healthcare utilization. A variety of interventions are used in this setting to treat UI, and use of pharmacologic therapy appears to be quite low. Appropriate use of interventional strategies that may include drug treatment for UI in the nursing home may reduce the substantial personal and cost burdens associated with this condition. However, clinicians may need population-specific scientific evidence in determining which nursing home patients will benefit most from pharmacotherapy.