United States Department of Justice findings letters in psychiatric hospital CRIPA cases: an aid or a distraction
The Civil Rights of Institutionalized Persons Act (CRIPA) of 1980 allows the United States Department of Justice (DOJ) to investigate and file lawsuits against certain institutions, including state and county psychiatric hospitals, where individuals within may face unconstitutional conditions. Subsequent to an investigation and before negotiations or litigation, the state is provided a Findings Letter generated by the DOJ that generally contains recommended remedial measures. It has never been determined to what extent a Findings Letter provides a state with a recommendation specific to the institution for corrective action before the state enters into negotiations with the DOJ. Three study groups were derived from a sample of 15 Findings Letters written to states concerning their psychiatric hospitals between 2003 and 2009. The individual recommended remedial measures, labeled texts of interest (TOI), were identified, and the degree of overlap among the Findings Letters was determined. To a surprising degree, TOIs overlapped to various extents, from exact copies of text to paraphrased versions, in Findings Letters written between 2003 and 2009 to different states and for multiple state hospitals in the same state. The recommended remedial measures provided in the DOJ's Findings Letters are not specific to each state hospital's deficiencies. The Findings Letters offer limited guidance to the state on how to remedy the deficiencies before negotiating with the DOJ. This lack of specificity causes inefficient and delayed remediation of unconstitutional conditions and other deficiencies in care and treatment in psychiatric hospitals. While the current process most often leads to improvements in state hospitals, it is a costly, inefficient remedy, despite the possibility of alternative remedial processes of less expensive and equal or greater effectiveness.
Conceptualization and measurement of mental health providers' recovery-promoting competence: the recovery promoting relationships scale (RPRS)
OBJECTIVE: The purpose of this study was to construct and validate an instrument that measures practitioners' competence to promote the recovery among individuals with psychiatric disabilities from the perspective of the person served. Items were developed based upon input from individuals served and practitioners as well as the extant literature on recovery. "Recovery-promoting competence" was conceptualized as a set of practitioner capabilities that promote the recovery process and enhance the working alliance.
METHOD: A scale was developed using a two-stage process that initially identified specific recovery-promoting competencies and then tested candidate items measuring those competencies. Item Response Theory and Classical Test Theory approaches were used to validate the instrument and assess its psychometric properties with a national sample of 382 individuals with psychiatric disabilities.
RESULTS: Analyses revealed two distinct sets of recovery-promoting competencies: (a) competencies that enhance clients' recovery, and (b) competencies that build and maintain a strong therapeutic or working alliance. The first set further differentiated into subcompetencies-enhancing clients' hopefulness, empowerment, and self-acceptance. The instrument had high internal consistency and acceptable stability over time, convergent, criterion, and known groups' validity.
CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: This scale is a tool for assessing mental health and rehabilitation practitioners' competencies from the perspective of the individual served which can be used both in research and program evaluation of agencies serving individuals with psychiatric disabilities.
Ten year research update (2001-2010): evaluations for competence to stand trial (adjudicative competence)
This article reviews and evaluates publications during 2001-2010 with relevance for assessments of competence to stand trial, referred to in this article as adjudicative competence. The review focuses specifically on articles that provide new concepts or data supported by research or case analyses. The studies are reviewed under the following headings: (i) systemic issues, (ii) conceptual guidelines for AC evaluations, (iii) AC assessment methods, (iv) empirical correlates of AC judgments and psycholegal abilities, (v) quality of AC evaluations and reports, (vi) interpretive issues, (vii) special populations (defendants who are elderly, defendants with intellectual disabilities), (viii) AC evaluations of juveniles, and (ix) treatment of incompetent defendants. Suggestions are offered for further research to advance the quality of clinical evaluations of adjudicative competence.
No sympathy for the devil: attributing psychopathic traits to capital murderers also predicts support for executing them
Mental health evidence concerning antisocial and psychopathic traits appears to be introduced frequently in capital murder trials in the United States to argue that defendants are a "continuing threat" to society and thus worthy of execution. Using a simulation design, the present research examined how layperson perceptions of the psychopathic traits exhibited by a capital defendant would impact their attitudes about whether he should receive a death sentence. Across three studies (total N = 362), ratings of a defendant's perceived level of psychopathy strongly predicted support for executing him. The vast majority of the predictive utility was attributable to interpersonal and affective traits historically associated with psychopathy rather than traits associated with a criminal and socially deviant lifestyle. A defendant's perceived lack of remorse in particular was influential, although perceptions of grandiose self-worth and a manipulative interpersonal style also contributed incrementally to support for a death sentence. These results highlight how attributions regarding socially undesirable personality traits can have a pronounced negative impact on layperson attitudes toward persons who are perceived to exhibit these characteristics.
Identification of factors that predict recurrent antisocial behavior is integral to the social sciences, criminal justice procedures, and the effective treatment of high-risk individuals. Here we show that error-related brain activity elicited during performance of an inhibitory task prospectively predicted subsequent rearrest among adult offenders within 4 y of release (N = 96). The odds that an offender with relatively low anterior cingulate activity would be rearrested were approximately double that of an offender with high activity in this region, holding constant other observed risk factors. These results suggest a potential neurocognitive biomarker for persistent antisocial behavior.
Areas of the brain modulated by single-dose methylphenidate treatment in youth with ADHD during task-based fMRI: a systematic review
OBJECTIVE: Attention-deficit/hyperactivity disorder (ADHD) is a psychiatric disorder affecting 5% of children. Methylphenidate (MPH) is a common medication for ADHD. Studies examining MPH's effect on pediatric ADHD patients' brain function using functional magnetic resonance imaging (fMRI) have not been compiled. The goals of this systematic review were to determine (1) which areas of the brain in pediatric ADHD patients are modulated by a single dose of MPH, (2) whether areas modulated by MPH differ by task type performed during fMRI data acquisition, and (3) whether changes in brain activation due to MPH relate to clinical improvements in ADHD-related symptoms.
METHODS: We searched the electronic databases PubMed and PsycINFO (1967-2011) using the following terms: ADHD AND (methylphenidate OR MPH OR ritalin) AND (neuroimaging OR MRI OR fMRI OR BOLD OR event related), and identified 200 abstracts, 9 of which were reviewed based on predefined criteria.
RESULTS: In ADHD patients the middle and inferior frontal gyri, basal ganglia, and cerebellum were most often affected by MPH. The middle and inferior frontal gyri were frequently affected by MPH during inhibitory control tasks. Correlation between brain regions and clinical improvement was not possible due to the lack of symptom improvement measures within the included studies.
CONCLUSIONS: Throughout nine task-based fMRI studies investigating MPH's effect on the brains of pediatric patients with ADHD, MPH resulted in increased activation within frontal lobes, basal ganglia, and cerebellum. In most cases, this increase "normalized" activation of at least some brain areas to that seen in typically developing children.
Symptoms of major depressive disorder (MDD) manifest variably across individuals. Accordingly, recent models of the disorder imply that MDD may be characterized according to independent symptom dimensions. In particular, several studies reveal that depression may be characterized along dimensions of negative affect, agitation and hostility, and lassitude and malaise. No research has examined the relationship between these dimensions and neuropsychological function. Towards this end, 133 in patients with unipolar MDD and 17 people without psychiatric illness were administered a brief battery of neuropsychological tests and the MMPI-2. Paralleling earlier research, principal component analysis of the MMPI-2 revealed symptom dimensions of negative affect, agitation, and lassitude and malaise. Multiple regression analyses showed that the negative affect and agitation dimensions accounted for significant variance on measures of executive function, speed of information processing, new learning, dexterity, and overall impairment. Lassitude and malaise failed to correspond with neuropsychological performance. Implications of these data for clinical practice and neural models of MDD are discussed.
Institutional Review Boards are mandated to carry out the requirements of the Common Rule, and it is widely agreed that they are appropriate and necessary mechanisms to ensure the ethical conduct of human research. In this paper, we suggest that the changes proposed in ANPRM, although generally helpful, fail to take into consideration how IRBs actually review applications and therefore do not adequately address some of the problems that may be leading to ineffective human subject protection.
Progressive levels of physical dependence to tobacco coincide with changes in the anterior cingulum bundle microstructure
BACKGROUND: The tobacco withdrawal syndrome indicates the development of neurophysiologic dependence. Clinical evidence indicates that neurophysiologic dependence develops through a set sequence of symptom presentation that can be assessed with a new 3-item survey measure of wanting, craving, and needing tobacco, the Level of Physical Dependence (PD). This study sought to determine if advancing neurophysiologic dependence as measured by the Level of PD correlates with characteristics of white matter structure measured by Fractional Anisotropy (FA).
METHODS: Diffusion-MRI based FA and diffusion tensor imaging probabilistic tractography were used to evaluate 11 smokers and 10 nonsmokers. FA was also examined in relation to two additional measures of dependence severity, the Hooked on Nicotine Checklist (HONC), and the Fagerstrom Test for Nicotine Dependence (FTND).
RESULTS: Among smokers, FA in the left anterior cingulate bundle (ACb) correlated negatively with the Level of PD (r = -0.68, p = 0.02) and HONC scores (r = -0.65, p = 0.03), but the correlation for the FTND did not reach statistical significance (r = -49, p = 0.12). With advancing Levels of PD, the density of streamlines between the ACb and precuneus increased (r = -0.67, p<0.05) and those between the ACb and white matter projecting to the superior-frontal cortex (r = -0.86, p = 0.0006) decreased significantly.
CONCLUSIONS: The correlations between neural structure and both the clinical Level of PD survey measure and the HONC suggest that the Level of PD and the HONC may reflect the microstructural integrity of white matter, as influenced by tobacco abuse. Given that the Level of PD is measuring a sequence of symptoms of neurophysiologic dependence that develops over time, the correlation between the Level of PD and neural structure suggests that these features might represent neuroplastic changes that develop over time to support the development of neurophysiologic dependence.
INTRODUCTION: Moderate intensity physical activity is recommended for individuals with diabetes to control glucose and prevent diabetes-related complications. The extent to which a diabetes diagnosis motivates patients to increase physical activity is unclear. This study used data from the Women's Health Initiative Observational Study (baseline data collected from 1993-1998) to examine change in physical activity and sedentary behavior in women who reported a diabetes diagnosis compared to women who did not report diabetes over 7 years of follow-up (up to 2005).
METHODS: Participants (n=84,300) were post-menopausal women who did not report diabetes at baseline [mean age=63.49; standard deviation (SD)=7.34; mean BMI=26.98 kg/m; SD=5.67]. Linear mixed model analyses were conducted adjusting for study year, age, race/ethnicity, BMI, education, family history of diabetes, physical functioning, pain, energy/fatigue, social functioning, depression, number of chronic diseases and vigorous exercise at age 18. Analyses were completed in August 2012.
RESULTS: Participants who reported a diabetes diagnosis during follow-up were more likely to report increasing their total physical activity (p=0.002), walking (p
CONCLUSION: A diabetes diagnosis may prompt patients to increase physical activity. Healthcare professionals should consider how best to capitalize on this opportunity to encourage increased physical activity and maintenance.
Comment on: Community treatment orders for patients with psychosis (OCTET): a randomised controlled trial. [Lancet. 2013]
All-Cause, Cardiovascular, and Cancer Mortality Rates in Postmenopausal White, Black, Hispanic, and Asian Women With and Without Diabetes in the United States: The Women's Health Initiative, 1993-2009
Using data from the Women's Health Initiative (1993-2009; n = 158,833 participants, of whom 84.1% were white, 9.2% were black, 4.1% were Hispanic, and 2.6% were Asian), we compared all-cause, cardiovascular, and cancer mortality rates in white, black, Hispanic, and Asian postmenopausal women with and without diabetes. Cox proportional hazard models were used for the comparison from which hazard ratios and 95% confidence intervals were computed. Within each racial/ethnic subgroup, women with diabetes had an approximately 2-3 times higher risk of all-cause, cardiovascular, and cancer mortality than did those without diabetes. However, the hazard ratios for mortality outcomes were not significantly different between racial/ethnic subgroups. Population attributable risk percentages (PARPs) take into account both the prevalence of diabetes and hazard ratios. For all-cause mortality, whites had the lowest PARP (11.1, 95% confidence interval (CI): 10.1, 12.1), followed by Asians (12.9, 95% CI: 4.7, 20.9), blacks (19.4, 95% CI: 15.0, 23.7), and Hispanics (23.2, 95% CI: 14.8, 31.2). To our knowledge, the present study is the first to show that hazard ratios for mortality outcomes were not significantly different between racial/ethnic subgroups when stratified by diabetes status. Because of the "amplifying" effect of diabetes prevalence, efforts to reduce racial/ethnic disparities in the rate of death from diabetes should focus on prevention of diabetes.
Dietary Magnesium Intake Improves Insulin Resistance among Non-Diabetic Individuals with Metabolic Syndrome Participating in a Dietary Trial
Many cross-sectional studies show an inverse association between dietary magnesium and insulin resistance, but few longitudinal studies examine the ability to meet the Recommended Dietary Allowance (RDA) for magnesium intake through food and its effect on insulin resistance among participants with metabolic syndrome (MetS). The dietary intervention study examined this question in 234 individuals with MetS. Magnesium intake was assessed using 24-h dietary recalls at baseline, 6, and 12 months. Fasting glucose and insulin levels were collected at each time point; and insulin resistance was estimated by the homeostasis model assessment (HOMA-IR). The relation between magnesium intake and HOMA-IR was assessed using linear mixed models adjusted for covariates. Baseline magnesium intake was 287 +/- 93 mg/day (mean +/- standard deviation), and HOMA-IR, fasting glucose and fasting insulin were 3.7 +/- 3.5, 99 +/- 13 mg/dL, and 15 +/- 13 muU/mL, respectively. At baseline, 6-, and 12-months, 23.5%, 30.4%, and 27.7% met the RDA for magnesium. After multivariate adjustment, magnesium intake was inversely associated with metabolic biomarkers of insulin resistance (P < 0.01). Further, the likelihood of elevated HOMA-IR (>3.6) over time was 71% lower [odds ratio (OR): 0.29; 95% confidence interval (CI): 0.12, 0.72] in participants in the highest quartile of magnesium intake than those in the lowest quartile. For individuals meeting the RDA for magnesium, the multivariate-adjusted OR for high HOMA-IR over time was 0.37 (95% CI: 0.18, 0.77). These findings indicate that dietary magnesium intake is inadequate among non-diabetic individuals with MetS and suggest that increasing dietary magnesium to meet the RDA has a protective effect on insulin resistance.
The interdomain interface in bifunctional enzyme protein 3/4A (NS3/4A) regulates protease and helicase activities
Hepatitis C (HCV) protein 3/4A (NS3/4A) is a bifunctional enzyme comprising two separate domains with protease and helicase activities, which are essential for viral propagation. Both domains are stable and have enzymatic activity separately, and the relevance and implications of having protease and helicase together as a single protein remains to be explored. Altered in vitro activities of isolated domains compared with the full-length NS3/4A protein suggest the existence of interdomain communication. The molecular mechanism and extent of this communication was investigated by probing the domain-domain interface observed in HCV NS3/4A crystal structures. We found in molecular dynamics simulations that the two domains of NS3/4A are dynamically coupled through the interface. Interestingly, mutations designed to disrupt this interface did not hinder the catalytic activities of either domain. In contrast, substrate cleavage and DNA unwinding by these mutants were mostly enhanced compared with the wild-type protein. Disrupting the interface did not significantly alter RNA unwinding activity; however, the full-length protein was more efficient in RNA unwinding than the isolated protease domain, suggesting a more direct role in RNA processing independent of the interface. Our findings suggest that HCV NS3/4A adopts an "extended" catalytically active conformation, and interface formation acts as a switch to regulate activity. We propose a unifying model connecting HCV NS3/4A conformational states and protease and helicase function, where interface formation and the dynamic interplay between the two enzymatic domains of HCV NS3/4A potentially modulate the protease and helicase activities in vivo.
Behavior problems among preschool children are common. They are important targets for intervention because early externalizing problems and self-regulation issues tend to persist without appropriate attention, and can affect later mental health and school achievement outcomes. However, few preschool curricula addressing social and emotional development exist, and evidence for effects are mixed. In this study, the Second Step Pre/Kindergarten Social and Emotional Learning curriculum was adapted and tested in a small cluster randomized pilot study of community preschool classrooms to determine if it could improve outcomes in: (1) individual children's teacher-rated behavior problems and prosocial skills; (2) classroom climate (classroom interactions and two measures of disruptive behavior); and (3) teacher interaction skills. Year 1 outcomes were modest and were accounted for by baseline differences. In Year 2, classroom climate, measured by independent observers, differed significantly in intervention classrooms, largely because of declines in control classrooms, and there was some evidence for better teacher interaction skills in intervention classrooms. The pattern of effects suggests important impacts on classroom quality worth investigating in a larger study. Both fidelity and implementation rates, as well as positive teacher responses to the curriculum, indicate potential for widespread adoption.
We report the performance of our approaches for protein-protein docking and interface analysis in CAPRI rounds 20-26. At the core of our pipeline was the ZDOCK program for rigid-body protein-protein docking. We then reranked the ZDOCK predictions using the ZRANK or IRAD scoring functions, pruned and analyzed energy landscapes using clustering, and analyzed the docking results using our interface prediction approach RCF. When possible, we used biological information from the literature to apply constraints to the search space during or after the ZDOCK runs. For approximately half of the standard docking challenges we made at least one prediction that was acceptable or better. For the scoring challenges we made acceptable or better predictions for all but one target. This indicates that our scoring functions are generally able to select the correct binding mode. (c) Proteins 2013;. (c) 2013 Wiley Periodicals, Inc.
A population-based dietary inflammatory index predicts levels of C-reactive protein in the Seasonal Variation of Blood Cholesterol Study (SEASONS)
OBJECTIVE: To perform construct validation of the population-based Dietary Inflammatory Index (DII) using dietary data from two different dietary assessments and serum high-sensitivity C-reactive protein (hs-CRP) as the construct validator.
DESIGN: Using data derived from (i) three 24 h dietary recalls (24HR) at baseline and at the end of each subsequent quarter (i.e. up to fifteen over a year) and (ii) a 7 d dietary recall (7DDR) measured at baseline and then quarterly, regression analyses were conducted to test the effect of the DII score on serum hs-CRP as dichotomous (3 mg/l), while controlling for important potential confounders.
SETTING: Existing data from the Seasonal Variation of Blood Cholesterol Study (SEASONS), a longitudinal observational study of healthy participants recruited in Worcester, MA, USA and participants were followed for 1 year.
SUBJECTS: Participants who had at least one hs-CRP measurement over her/his 1-year participation (n 495 for 24HR, n 559 for 7DDR).
RESULTS: Higher DII scores were associated with values of hs-CRP >3 mg/l (OR = 1.08; 95 % CI 1.01, 1.16, P = 0.035 for the 24HR; and OR = 1.10; 95 % CI 1.02, 1.19, P = 0.015 for the 7DDR).
CONCLUSIONS: The population-based DII was associated with interval changes in hs-CRP using both the 24HR and 7DDR. The success of this first-of-a-kind attempt at relating individuals' intakes of inflammation-modulating foods using this refined DII, and the finding that there is virtually no drop-off in predictive capability using a structured questionnaire in comparison to the 24HR standard, sets the stage for use of the DII in a wide variety of other epidemiological and clinical studies.
Factor H-Dependent Alternative Pathway Inhibition Mediated by Porin B Contributes to Virulence of Neisseria meningitidis
The identification of "factor H binding protein (fHbp)-null" invasive meningococcal isolates and the realization that widespread use of fHbp-based vaccines could herald selection of such strains prompted us to characterize novel mechanisms of alternative pathway (AP) inhibition on meningococci. Of seven strains engineered to lack four known AP-inhibiting molecules, capsular polysaccharide, lipooligosaccharide sialic acid, fHbp, and neisserial surface protein A (quadruple mutants), four strains inhibited human AP-mediated C3 deposition. All four expressed the porin B2 (PorB2) molecule, and three strains belonged to the hypervirulent ST-11 lineage. Consistent with reduced C3 deposition, the rate of C3a generation by a PorB2 isolate was lower than that by a PorB3 strain. Allelic replacement of PorB3 with PorB2, in both encapsulated and unencapsulated strains, confirmed the role of PorB2 in AP inhibition. Expression of PorB2 increased resistance to complement-dependent killing relative to that seen in an isogenic PorB3-expressing strain. Adult rabbit and mouse APs were unimpeded on all mutants, and human fH inhibited nonhuman C3 deposition on PorB2-expressing strains, which provided functional evidence for human fH-dependent AP regulation by PorB2. Low-affinity binding of full-length human fH to quadruple mutants expressing PorB2 was demonstrated. fH-like protein 1 (FHL-1; contains fH domains 1 through 7) and fH domains 6 and 7 fused to IgG Fc bound to one PorB2-expressing quadruple mutant, which suggested that fH domains 6 and 7 may interact with PorB2. These results associate PorB2 expression with serum resistance and presage the appearance of fHbp-null and hypervirulent ST-11 isolates that may evade killing by fHbp-based vaccines. IMPORTANCE The widespread use of antimeningococcal vaccines based on factor H (fH) binding protein (fHbp) is imminent. Meningococci that lack fHbp were recently isolated from persons with invasive disease, and these fHbp-null strains could spawn vaccine failure. Our report provides a molecular basis for an explanation of how fHbp-null strains may evade the host immune system. Meningococci possess several mechanisms to subvert killing by the alternative pathway (AP) of complement, including production of the fHbp and NspA fH binding proteins. Here we show that a meningococcal protein called porin B2 (PorB2) contributes to inhibition of the AP on the bacterial surface. A majority of the "fHbp-null" isolates identified, as well as all members of a "hypervirulent" lineage (called ST-11), express PorB2. Our findings highlight the potential for the emergence of fHbp-negative strains that are able to regulate the AP and may be associated with fHbp vaccine failure.
Patient-reported outcomes after total knee replacement vary on the basis of preoperative coexisting disease in the lumbar spine and other nonoperatively treated joints: the need for a musculoskeletal comorbidity index
BACKGROUND: Although the majority of patients report substantial gains in physical function following primary total knee replacement, the degree of improvement varies widely. To understand the potential role of preoperative pain due to other musculoskeletal conditions on postoperative outcomes, we quantified bilateral knee and hip pain and low back pain before primary total knee replacement and evaluated its association with physical function at six months after total knee replacement.
METHODS: A prospective cohort of 180 patients having primary unilateral total knee replacement reported joint-specific pain in right and left hips and knees (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC] pain) as well as the low back (Oswestry Disability Index) before surgery. Participants also completed the Short Form-36 (SF-36), including the physical and mental component summary scores, before and at six months after surgery.
RESULTS: Of the 180 patients, 110 (61%) were women; the mean age was 65.1 years, the mean body mass index (BMI) was 32.5 kg/m2, and mean SF-36 physical component summary score reported before the total knee replacement was 33.1. Before total knee replacement, 56.1% of the patients reported no or mild pain in the nonoperatively treated knee, hips, and low back. In addition, 22.2% of the patients had moderate to severe pain in one location; 12.8%, in two locations; and 8.9%, in three or four locations. Women reported more moderate to severe pain than men did in the nonoperatively treated knee (30% versus 11%; p andlt; 0.004) and ipsilateral hip (26% versus 11%; p andlt; 0.02). At six months, the mean physical component summary score was lower among patients with a greater number of preoperative locations of moderate to severe pain. After adjusting for age, sex, BMI, and SF-36 mental component summary score, moderate to severe preoperative pain in the contralateral knee (p = 0.013), ipsilateral (p = 0.014) and contralateral hip (p = 0.026), and low back (p andlt; 0.001) was significantly associated with poorer function at six months after total knee replacement.
CONCLUSIONS: Preoperative musculoskeletal pain in the low back and nonoperatively treated lower extremity joints is associated with poorer physical function at six months after total knee replacement. The degree of functional improvement varies with the burden of musculoskeletal pain in other weight-bearing locations.
LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.
BACKGROUND: In the largest overhaul to Medicare since its creation in 1965, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 established Part D in 2006 to improve access to essential medication among disabled and older Americans. Despite previous evidence of a positive impact on the general Medicare population, Part D's overall effects on long-term care (LTC) are unknown.
OBJECTIVE: The purpose of this systematic review was to evaluate the literature regarding Part D's impact on the LTC context, specifically costs to LTC residents, providers and payers; prescription drug coverage and utilization; and clinical and administrative outcomes.
DATA SOURCES: Four electronic databases [PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Health Business Fulltext Elite and Science Citation Index Expanded], selected US government and non-profit websites, and bibliographies were searched for quantitative and qualitative studies characterizing Part D in the LTC context. Searches were limited to studies that may have been published between 1 January 2006 (date of Part D implementation) and 8 January 2013.
STUDY SELECTION: Systematic searches identified 1,624 publications for a three-stage (title, abstract and full-text) review. Included publications were in English language; based in the US; assessed Part D-related outcomes; and included or were directly relevant to LTC residents or settings. News articles, reviews, opinion pieces, letters or commentaries; case reports or case series; simulation or modeling studies; and summaries that did not report original data were excluded.
STUDY APPRAISAL AND SYNTHESIS METHODS: A standardized form was used to abstract study type, study design, LTC setting, sources of data, method of data collection, time periods assessed, unit of observation, outcomes and results. Methodological quality was assessed using modified criteria specific to quantitative and qualitative studies.
RESULTS: Eleven quantitative and eight qualitative studies met inclusion criteria. In the seven years since its implementation, Part D decreased out-of-pocket costs among enrolled nursing home residents and potentially increased costs borne by LTC facilities. Coverage of prescription drugs frequently used by older adults was adequate, except for certain drugs and alternative formulations of importance to LTC residents. The use of medications that raise safety concerns was decreased, but overall drug utilization may have been unaffected. Although there was uncertain impact on clinical outcomes, quantitative studies demonstrated evidence of unintended health consequences. Qualitative studies consistently revealed increased administrative burden among providers.
LIMITATIONS: Empirical evidence of Part D's LTC impact was sparse. Due to limitations in available types of data, quantitative studies were generically lacking in methodological rigor. Qualitative studies suffered from lack of clarity of reporting. As future studies use clinical Medicare data, study quality is expected to improve.
CONCLUSION: Although LTC-specific policies continue to evolve, it appears that the prescription drug benefit may require further modifications to more effectively provide for LTC residents' unique medication needs and improve their health outcomes. Adjustments may be needed for Part D to be more compatible with LTC prescription drug delivery processes.