Life Engagement Improvement Following Initiation of Brexpiprazole Treatment in Patients with MDD: A Naturalistic, Retrospective Real-World Study.

Purpose: Life engagement encompasses concepts such as life fulfillment, well-being, and participation in meaningful activities, encompassing cognitive, physical, social, and emotional dimensions. Patients with MDD experience impaired functioning across multiple domains of life engagement and have ranked concepts related to life engagement and fulfillment as important predictors of treatment success. Post-hoc analyses of three clinical trials of patients with MDD treated adjunctively with brexpiprazole have reported a significantly greater improvement in life engagement. This study investigated improvements in life engagement among patients with MDD following initiation of brexpiprazole treatment using a real-world dataset. Patients and Methods: Information was extracted from semi-structured clinical notes of the Mental Status Examination (MSE) of patients in a real-world setting to develop an outcome measure for quantifying life engagement of psychiatric patients. Measures of life engagement and its four sub-domains (emotional, physical, social, and cognitive) were calculated at each clinical visit for 624 adult patients with MDD during the 6 months following brexpiprazole initiation. Paired t-tests assessed differences between the index event and time periods within 6 months of the index event. Kaplan-Meier survival analyses were used to quantify the improvement in life engagement scores following brexpiprazole initiation. Results: The study identified 54 clinical features associated with life engagement. Statistically significant improvements were observed from as early as 1 month following brexpiprazole initiation, with 20.6%, 37.9%, and 53.9% of the patients demonstrating improved life engagement scores within 1, 3, and 6 months, respectively. The improvements were particularly apparent for the emotional and social sub-domains. Conclusion: The results of this study provide evidence of improved life engagement following brexpiprazole initiation in a real-world dataset.

The Impact of Agitation in Dementia on Caregivers: A Real-World Survey.

BACKGROUND: Dementia patients frequently depend on caregivers. Agitation is a common behavioral dementia symptom particularly burdensome to patients and caregivers. OBJECTIVE: To assess the association of agitation severity with non-professional caregiver hours, burden, health status, and productivity. Secondarily, to assess the association of agitation severity with these outcomes for patients receiving remote (not living with the patient) and proximate (living with the patient) caregiving. METHODS: A retrospective analysis of physician and non-professional caregiver-reported data from a US point-in-time survey. Patients were aged ≥50 years, with early cognitive impairment or dementia. Regression analyses compared outcomes by agitation severity; covariates included age, sex, and clinical characteristics. RESULTS: Data were included for 1,349 patients (non-agitated n = 656, agitated n = 693; no care n = 305, remote care n = 248, proximate care n = 691; unknown care n = 105). Greater agitation was significantly associated (p < 0.05) in all caregivers with increasing: Zarit Burden Interview (ZBI) Total Caregiver Burden, Personal Strain, Role Strain, and Guilt; Work Productivity and Activity Index (WPAI) presenteeism, overall work impairment, and total activity impairment. Higher ZBI Total Caregiver Burden, Personal Strain, and Role Strain were associated with greater agitation in proximate caregivers and higher ZBI Guilt associated with greater agitation in remote caregivers (p < 0.05). Higher WPAI presenteeism and total activity impairment were associated (p < 0.05) with greater agitation in proximate caregivers. Caregiving hours increased with increasing agitation for proximate caregiving (p = 0.001). CONCLUSION: Greater agitation severity was associated with higher caregiver burden and lower productivity, with higher indirect costs a likely outcome of agitation.

The Economic Burden of Posttraumatic Stress Disorder in the United States From a Societal Perspective.

Objective: To estimate the economic burden of posttraumatic stress disorder (PTSD) in the United States civilian and military populations from a societal perspective.Methods: A prevalence-based and human capital approach was used to estimate the total excess costs of PTSD in 2018 from insurance claims data, academic literature, and governmental publications. Excess direct health care costs (pharmacy, medical), direct non-health care costs (research and training, substance use, psychotherapy, homelessness, disability), and indirect costs (unemployment, productivity loss, caregiving, premature mortality) associated with PTSD were compared between adults with PTSD and adults without PTSD, or the general population if information was not available for adults without PTSD.Results: The total excess economic burden of PTSD in the US was estimated at $232.2 billion for 2018 ($19,630 per individual with PTSD). Total excess costs were $189.5 billion (81.6%) in the civilian population and $42.7 billion (18.4%) in the military population, corresponding to $18,640 and $25,684 per individual with PTSD in the civilian and military populations, respectively. In the civilian population, the excess burden was driven by direct health care ($66.0 billion) and unemployment ($42.7 billion) costs. In the military population, the excess burden was driven by disability ($17.8 billion) and direct health care ($10.1 billion) costs.Conclusions: The economic burden of PTSD goes beyond direct health care costs and has been found to rival costs for other costly mental health conditions. Increased awareness of PTSD, development of more effective therapies, and expansion of evidence-based interventions may be warranted to reduce the large clinical and economic burden of PTSD.

Agitation in Dementia: Real-World Impact and Burden on Patients and the Healthcare System.

BACKGROUND: At least 90%of patients with dementia experience behavioral or neuropsychiatric symptoms including agitation, psychotic symptoms, apathy, depression, and sleep disturbances. Agitation has been reported to be experienced by 60%of patients with mild cognitive impairment and 76%of patients with Alzheimer's disease. OBJECTIVE: We aimed to assess the impact of agitation in patients with dementia on healthcare resource utilization (HCRU) and healthcare costs. METHODS: This was a retrospective analysis of physician-reported patient data from a point-in-time survey. Patients included were aged≥50 years, with early cognitive impairment or dementia. Agitated and non-agitated patients were compared. Regression analyses assessed the relationship of agitation score (calculated from number/severity of agitation symptoms) with outcomes, with covariates including age and Mini-Mental State Examination score. Sensitivity analyses compared patients with 0 and≥2 agitation symptoms following propensity score matching on the base-case covariates. RESULTS: Data were included for 1,349 patients (agitated, n = 693; non-agitated, n = 656). Based on regression analyses, agitation score was correlated with proportion of patients with professional caregivers (p < 0.01), institutionalized (p < 0.01), hospitalized in a psychiatric ward (p < 0.05), and receiving an antipsychotic/antidepressant (both p < 0.001); number of consultations with a healthcare professional (HCP), psychiatrist, or psycho-geriatrician; number and cost of hospitalizations (p < 0.01); cost of HCP consultations (p < 0.001); and total direct healthcare costs (p < 0.001). Sensitivity analyses generally supported the base-case analysis. CONCLUSION: Agitation in dementia is associated with increased HCRU and healthcare costs. Effective therapies are needed to address agitation in dementia, with the potential to alleviate patient impact, HCRU, and healthcare costs.

Impact of agitation in long-term care residents with dementia in the United States.

OBJECTIVES: To describe characteristics and compare clinical outcomes including falls, fractures, infections, and neuropsychiatric symptoms (NPS) among long-term care residents with dementia with and without agitation. METHODS: A cross-sectional secondary analysis of administrative healthcare data was conducted whereby residents with dementia residing in a long-term care facility for ≥12 months were identified from the AnalytiCare LLC database (10/2010-06/2014) and were classified into mutually exclusive cohorts (Agitation Cohort or No-Agitation Cohort) based on available agitation-related symptoms. Entropy balancing was used to balance demographic and clinical characteristics between the two cohorts. The impact of agitation on clinical outcomes was compared between balanced cohorts using weighted logistic regression models. RESULTS: The study included 6,265 long-term care residents with dementia among whom, 3,313 were included in the Agitation Cohort and 2,952 in the No-Agitation Cohort. Prior to balancing, residents in the Agitation Cohort had greater dementia-related cognitive impairment and clinical manifestations compared to the No-Agitation Cohort. After balancing, residents with and without agitation, respectively, received a median of five and four distinct types of medications (including antipsychotics). Further, compared to residents without agitation, those with agitation were significantly more likely to have a recorded fall (OR = 1.58), fracture (OR = 1.29), infection (OR = 1.18), and other NPS (OR = 2.11). CONCLUSIONS: Agitation in long-term care residents with dementia was associated with numerically higher medication use and an increased likelihood of experiencing falls, fractures, infections, and additional NPS compared to residents without agitation, highlighting the unmet need for effective management of agitation symptoms in this population.

Mental Illness Disclosure in the Workplace: An Opportunity for Improvement.

Background: The Americans with Disabilities Act (ADA) prohibits discrimination based on physical or mental disabilities and requires that employers provide reasonable accommodations to workers with disabilities who can perform their essential job functions. However, the ADA also states that an employer is not required to hire or keep an individual with a psychiatric disability if it poses a direct threat to his or her safety or the safety of others. Objectives: To identify employers' disclosure requirements for mental illness diagnosis or treatment during the job application process and/or as a condition of ongoing employment, to determine disclosure requirements of state and federal licensing bodies, and to evaluate the legality of disclosure of mental health status. Methods: We conducted an Internet-based search to identify public and private employers' disclosure requirements based on 4 keyword combinations, including "employment/mental health," "employment/mental illness," "license application/mental illness," and "license application/mental health." Other employers were included based on known federal and/or state certification requirements or a governing body policy for employee suitability and fitness. A panel of 3 investigators reviewed the data and analyzed the key findings, industry trends, and workplace implications. Results: Of the 23 industries (eg, construction, government, military, transportation) investigated, 5 were public and 18 were private. Public employees and government-regulated companies often required disclosure of mental health conditions because of the nature of the work. Private companies showed more variability than public in whether applications contained disclosure requirements, some of which were not compliant with the ADA regulations. Conclusion: Across the United States, job applicants and workers are often asked to disclose mental health status as a condition of employment. Consequently, applicants and workers may hide mental health issues, resulting in the underuse of mental health resources by those in need.

Impact of Atypical Antipsychotics as Adjunctive Therapy on Psychiatric Cost and Utilization in Patients with Major Depressive Disorder.

INTRODUCTION: Patients with major depressive disorder (MDD) incur high costs, despite established treatment options. Adding an atypical antipsychotic (AAP) to antidepressant therapy has shown to reduce depressive symptoms in MDD, but it remains unclear with which adjunctive AAP to initiate. As economic burden is one factor that can influence treatment selection, this study's objective was to evaluate the impact of adjunctive AAP choice on psychiatric costs and healthcare utilization in MDD. MATERIALS AND METHODS: This retrospective cohort study analyzed de-identified data from: (1) IBM® MarketScan® Commercial (C), Medicare Supplemental (MS), and MarketScan Multi-State Medicaid (M) Databases, and (2) Optum® Clinformatics® Datamart. Adult MDD patients were included if they had: initiated adjunctive AAPs during study identification period (7/1/15-9/30/16 MarketScan C/MS, and Optum; 7/1/15-6/30/16 MarketScan M), and ≥12 months of continuous enrollment before (baseline) and after (follow-up) first treatment date. Models included generalized linear models (GLMs) for psychiatric costs (total inpatient and outpatient services, excluding outpatient pharmacy costs), and a two-part model (logistic regression for psychiatric hospitalizations, GLM for psychiatric hospitalization costs among hospitalized patients); models were adjusted for baseline characteristics. RESULTS: The final study sample consisted of 10,325 patients (7657 aripiprazole, 1219 brexpiprazole, 827 lurasidone, 622 quetiapine). Using brexpiprazole as reference, lurasidone and quetiapine users had $1662 and $3894 higher psychiatric costs, respectively. Psychiatric costs were not statistically significantly different between aripiprazole and brexpiprazole (p>0.05). Quetiapine users had $15,159 (p<0.001) higher psychiatric hospitalization costs among those hospitalized, and higher odds of psychiatric hospitalization [2.11 (1.46-3.04); p<0.001] compared to brexpiprazole users. No statistically significant differences observed in psychiatric hospitalization risk comparing aripiprazole and lurasidone with brexpiprazole (p>0.05). CONCLUSION: In MDD, brexpiprazole users had significantly lower psychiatric costs than lurasidone and quetiapine users, and significantly lower psychiatric hospitalization risk than quetiapine users. Adjunctive AAP choice may impact subsequent healthcare costs and utilization in MDD.

Health Care Cost in Patients With Schizophrenia Treated With Brexpiprazole Versus Other Oral Atypical Antipsychotic Therapy.

PURPOSE: Brexpiprazole is an oral atypical antipsychotic (OAA) for the treatment of schizophrenia (SCZ). This study compared all-cause and psychiatric inpatient hospitalization and medical costs in adult patients with SCZ newly treated with brexpiprazole versus other US Food and Drug Administration-approved OAAs in a real-world setting. METHODS: This retrospective cohort study analyzed data from: (1) the IBM MarketScan Commercial and Medicare Supplemental databases, and the MarketScan Multi-State Medicaid database; and (2) the de-identified Optum Clinformatics Datamart. Adult patients were identified if they had SCZ and initiated either brexpiprazole or another OAA during the study identification period (July 1, 2015, to September 30, 2016, for MarketScan Commercial and Medicare Supplemental and for Optum; July 1, 2015, to June 30, 2016, for MarketScan Multi-State Medicaid) and had ≥12 months of continuous enrollment before (baseline) and after (follow-up) the first treatment date. Linear regression analyses were performed to test associations between treatment groups (brexpiprazole vs another OAA) and costs (total and medical); negative binomial regression models were used to estimate number of hospitalizations per year, adjusting for baseline characteristics and medication adherence to index treatment during the 12-month follow-up. FINDINGS: The final study sample consisted of 6254 patients with SCZ: 176 initiated brexpiprazole; 391, ziprasidone; 453, paliperidone; 523, lurasidone; 786, aripiprazole; 1234, quetiapine; 1264, olanzapine; and 1427, risperidone. Controlling for baseline characteristics and medication adherence, the adjusted number of hospitalizations (both all-cause and psychiatric), all-cause total costs, and all-cause medical costs did not differ across groups. Brexpiprazole users had the lowest mean psychiatric costs among all OAA users ($12,013; 95% bootstrap CI, 7488-16,538). Compared with brexpiprazole users, paliperidone (incidence rate ratio [95% CI], 1.52 [1.05-2.19]; P = 0.027) and quetiapine (incidence rate ratio [95% CI], 1.47 [1.04-2.07]; P = 0.029) users had more psychiatric hospitalizations per year. Paliperidone had higher psychiatric costs than brexpiprazole (total, $32,066 [95% bootstrap CI, 28,779-35,353] vs $23,851 [18,907-28,795]; medical, $19,343 [16,294-22,392] vs $12,013 [7488-16,538]). Psychiatric medical costs were also $6744 higher in olanzapine users (95% bootstrap CI, 1694-11,795; P = 0.009) than in brexpiprazole users. IMPLICATIONS: Patients with SCZ treated with brexpiprazole had fewer psychiatric hospitalizations and lower psychiatric costs than those treated with paliperidone. Differences in the number of all-cause hospitalizations and medical costs among treatments were not statistically significant. Although treatment decisions are driven by a number of factors (eg, clinical circumstances and drug costs), choice of OAA may affect health care costs.

Use of Initial Noninvasive Cardiac Testing and Association with Downstream Healthcare Resource: A Retrospective Review of Resources Used Across a 12-Month Window for Probable Type I Myocardial Infarction Patients.

BACKGROUND: Clinical guidelines provide clinicians with substantial discretion in the use of noninvasive cardiac testing for patients with suspected coronary artery disease. Repeat testing, frequent emergency department (ED) visits, and increases in other cardiac-related procedures can be a burden on patients and payers and can complicate treatment planning. We assessed downstream healthcare resource utilization (HCRU) for patients undergoing initial single-photon emission computed tomography (SPECT), myocardial perfusion imaging (MPI), stress echocardiography (ECHO), or exercise treadmill testing (ETT) with probable type I myocardial infarction (MI). METHODS: Electronic medical records data from 12,130 patients with probable type I MI presenting to EDs within a large healthcare system comprised of 11 adult hospitals were retrospectively analyzed. Logistic and linear regression determined the individual contribution of SPECT-MPI, ETT, and ECHO on repeat cardiovascular (CV) testing, inpatient visits, outpatient visits, and cardiac-related costs within 12 months of the index visit. RESULTS: The majority of patients received SPECT-MPI for the index-testing event (56.5%), followed by ETT (29.2%) and ECHO (14.3%). Patients who had SPECT-MPI at the index visit were less likely to have a repeat CV testing visit (odds ratio [OR] 0.77, 95% confidence interval [CI] 0.62‒0.96; p = 0.020) or an inpatient visit (OR 0.70, 95% CI 0.49‒0.98; p = 0.039) than those who underwent ETT or ECHO. ETT and ECHO were not predictive of any outcome. CONCLUSIONS: SPECT-MPI does not result in more downstream HCRU than ETT or ECHO and is associated with a lower likelihood of repeat non-invasive CV testing and inpatient visits.

Attributes of nuclear imaging centers impacting physician referrals for single-photon emission computed tomography myocardial perfusion imaging tests.

AIM: To evaluate nuclear imaging center attributes that cardiologists and primary care physicians (PCPs) consider when referring patients for single-photon emission computed tomography myocardial perfusion imaging (SPECT-MPI) tests, and how these attributes impact physician referral decisions in the United States. METHODS: A targeted literature review and seven one-to-one interviews with physicians and imaging center directors were conducted to identify attributes that could impact physicians' referral decisions. The impact of the identified attributes was assessed via an online discrete choice survey among eligible PCPs and cardiologists randomly selected from a nationally representative panel, and quantified with an odds ratio (OR) scale estimated with a multivariable logistic regression. RESULTS: Nine two-level attributes were identified: ease of the referral process, waiting time for tests, insurance preauthorization assistance, time to receive results, conclusive test reports, patient satisfaction, a protocol for rapid conversion from an exercise to a pharmacological stress test, patient communication, and assistance with parking/wheelchair access. A total of 410 physicians, including 208 (50.7%) cardiologists and 202 (49.3%) PCPs completed the survey. Among all physicians, a protocol that allows for a rapid conversion from an exercise to a pharmacological stress test (OR = 2.9) and preauthorization assistance (OR = 2.6) were the most impactful attributes. Additionally, cardiologists preferred imaging centers that provide an easy referral process (OR = 2.7), while PCPs favored centers offering a conclusive test report (OR = 2.4). LIMITATIONS: Some center features that might impact physician referral decision were not evaluated in this study, if they were not easily changeable from an imaging center's perspective. CONCLUSIONS: The availability of a protocol for rapid conversion from an exercise to a pharmacological stress test and preauthorization assistance had the most significant impact on physician referral decisions for SPECT-MPI. Additionally, cardiologists preferred centers providing an easy referral process, while PCPs favored those offering a concluding statement and actionable steps in test reports.

Congruence between urban adolescent and caregiver responses to questions about the adolescent's asthma.

In clinical and research settings, it is increasingly acknowledged that adolescents may be better positioned than their caregivers to provide information in regard to their own health status, including information related to asthma. Very little is known, however, about the congruence between adolescent and caregiver responses to questions about asthma beyond reports of symptoms. We analyzed data for 215 urban, primarily African-American adolescent-caregiver pairs. Adolescents and caregiver reports concerning the adolescent's asthma-related medical history were moderately correlated and not found to differ at the aggregate level. Correlations between adolescent and caregiver reports of the adolescent's asthma symptoms and functional status were weak, although these differences deteriorated at the aggregate level. Adolescent-caregiver reports of symptoms and functioning were more likely to be in agreement if the adolescent was older, if school personnel were unaware of the child's asthma, and if the adolescent's asthma was classified as mild intermittent. For questions concerning the frequency of hospitalizations, emergency department visits, and physician visits, moderate correlations between adolescent and caregiver responses were noted, although with some differences at the aggregate level. Findings suggest that, when adolescents and their caregivers are asked about the adolescent's asthma in clinical and research settings, the extent to which the two perspectives are likely to agree depends on the type of information sought. Clinicians and researchers may obtain more accurate information if questions about symptoms and functional status are directed toward adolescents.

A developmental, community, and psychosocial approach to food allergies in children.

Recent estimates show that food allergies affect a substantial proportion of children in the United States and appear to have increased in prevalence. At present, management of food allergies consists of strict avoidance of the responsible allergen and an appropriate response should a reaction occur. Creating safe environments for the growing number of children with food allergies requires a partnership between affected families and members of the caregiving and educational communities. This article reviews issues affecting children with food allergies at different stages of psychosocial development and discusses strategies that can be implemented to promote food safety within child care and school environments as well as in the community. It also presents an overview of policy developments at the state and national level that have implications for children with food allergies.

Blowing the whistle: what do African American adolescents with asthma and their caregivers understand by "wheeze?".

AIMS: To investigate what African American adolescents with asthma and their caregivers understand by "wheeze". METHODS: Caregivers (n = 35) and adolescents (n = 35) were each asked to describe what they understood by "wheeze". Respondents were also shown a video clip of an adolescent wheezing and asked: a) to describe the breathing of the adolescent in the video; and, b) whether the adolescent respondent's breathing had ever been similar to the video-presented symptoms. RESULTS: Most caregivers described wheeze in terms of sound alone (61.8%) while the majority of adolescents described wheeze as something that is felt (55.8%). Few caregivers and adolescents (5.8% each) included "whistling" in their descriptions of "wheeze". Most caregivers and adolescents used the word "wheeze" when describing the video clip, but nearly one-quarter of the caregivers and one-third of the adolescents felt that the adolescent's breathing was never similar to the video. CONCLUSION: Caregiver and adolescents descriptions of wheeze are different from each other and both may be different from clinical definitions of the term. Study findings have implications for the ways in which questions about "wheeze" are framed and interpreted.

Working with a Head Start population with asthma: lessons learned.

The Early Childhood Asthma Project involved asthma case identification in 35 Head Start centers in Detroit, MI, and attempted implementation of an intervention designed to help families manage a child's asthma more effectively. Surveys were distributed to the parents of all Head Start children (3408), and 2198 complete surveys were returned. Case detection found probable asthma in 30% of the children whose parent returned a sufficiently complete survey. Implementation of the intervention was unsuccessful in this setting. Obstacles to effective implementation included the sample's low participation and high attrition, limited involvement of Head Start personnel, factors related to the program approach, and the target population's beliefs about asthma.

Community coalitions to control chronic disease: Allies against asthma as a model and case study.

There is a rich and extensive literature regarding coalitions as vehicles for amassing resources, influence, and energy in pursuit of a health goal. Despite insufficient empirical data regarding outcome, a number of observers have posited the aspects of coalition processes thought to lead to goal attainment. The supplement, which this article is part of, is devoted to an examination of how these elements fitted together (or did not) in the seven areas across the United States where Allies coalitions devoted themselves to achieving asthma control. The aim of this article is to present the theoretical bases for the work of the coalitions. It illustrates and emphasizes how the community context influenced coalition development, how membership was involved in and assessed coalition processes and structures, and the community-wide actions that were instituted and the capacities they were trying to strengthen.

Collaborative design and implementation of a multisite community coalition evaluation.

Evaluation designs assessing community coalitions must balance measures of how coalitions do their work and evidence that the coalitions are making a difference. The Allies cross-site evaluation attempts to determine the combined effects of the seven coalitions' work at the individual, organizational, and community levels. Principal components considered are (a) contextual factors of the coalition community, (b) coalition processes and structure, (c) planning and planning products, (d) implementation actions, (e) activities and collaborations, (f) anticipated intermediate outcomes, and (g) expected asthma related health outcomes. Measurements are quantitative and qualitative, and data generated by these methods are used as ends in themselves and as a way to confirm or inform other measures. Evaluation has been an integral part of the planning and implementation phases of the Allies coalition work, with a priority of involving all of the partners in conceiving of and deciding upon the elements of assessment.

Engaging the community in coalition efforts to address childhood asthma.

For health improvement efforts to effectively address community needs, community members must be engaged in planning and implementing public health initiatives. For Allies Against Asthma's coalitions, the community included not only the subpopulation of individuals who suffer disproportionately from asthma but also the individuals and institutions that surround them. Through a quantitative self-assessment survey, informal discussion among coalition leadership, and interviews with key informants, data relevant to community engagement identified a number of important ways the Allies coalitions approached community involvement. Respondents' comments made clear that the way the coalitions conduct their work is often as important as what they do. Across coalitions, factors that were identified as important for community involvement included (a) establishing a commitment to community involvement, (b) building trust, (c) making participation feasible and comfortable, (d) responding to community identified needs, (e) providing leadership development opportunities, and (f) building a shared commitment to desired outcomes.

Improving quality of care and promoting health care system change: The role of community-based coalitions.

As part of their community action plans, the Allies Against Asthma coalitions have developed efforts to improve quality of care and promote health care system change. All the coalitions have used an interdisciplinary collaborative approach to design these strategies and demonstrated a range of intervention approaches appropriate to their local context and circumstances. The coalitions' collective experience suggests that coalitions provide three key forces for quality improvement and change that may be lacking in the current fragmented U.S. health care system--motivation to change the status quo, integration across systems, and accountability for results. The collaborative and empowering processes that a coalition model encourages and the direct advocacy opportunity provided to the consumer appear to bring these forces into play.