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1.  Effect of Multicomponent Interventions on Caregiver Burden and Depression: The REACH Multisite Initiative at 6-Month Follow-Up 
Psychology and aging  2003;18(3):361-374.
Meta-analysis was used to examine pooled parameter estimates of 9 active compared with 6 control conditions of the Resources for Enhancing Alzheimer’s Caregiver Health (REACH) project at 6 months on caregiver burden and depressive symptoms. Associations of caregiver characteristics and outcomes were examined. For burden, active interventions were superior to control conditions (p = .022). Also, active interventions were superior to control conditions for women versus men and for caregivers with lower education versus those with higher education. For depressive symptoms, a statistically significant association of group assignment was found for Miami’s family therapy and computer technology intervention (p = .034). Also, active interventions were superior to control conditions for Hispanics, nonspouses, and caregivers with lower education. Results suggest interventions should be multicomponent and tailored.
PMCID: PMC2583061  PMID: 14518800
2.  A Home-Based Intervention to Reduce Depressive Symptoms and Improve Quality of Life in Older African Americans 
Annals of internal medicine  2013;159(4):243-252.
Effective care models for treating older African Americans with depressive symptoms are needed.
To determine whether a home-based intervention alleviates depressive symptoms and improves quality of life in older African Americans.
Parallel, randomized trial stratified by recruitment site. Interviewers assessing outcomes were blinded to treatment assignment. ( NCT00511680)
A senior center and participants’ homes from 2008 to 2010.
African Americans aged 55 years or older with depressive symptoms.
A multicomponent, home-based intervention delivered by social workers or a wait-list control group that received the intervention at 4 months.
Self-reported depression severity at 4 months (primary outcome) and depression knowledge, quality of life, behavioral activation, anxiety, function, and remission at 4 and 8 months.
Of 208 participants (106 and 102 in the intervention and wait-list groups, respectively), 182 (89 and 93, respectively) completed 4 months and 160 (79 and 81, respectively) completed 8 months. At 4 months, participants in the intervention group showed reduced depression severity (difference in mean change in Patient Health Questionnaire-9 score from baseline, −2.9 [95% CI, −4.6 to −1.2]; difference in mean change in Center for Epidemiologic Studies Depression Scale score from baseline, −3.7 [CI, −5.4 to −2.1]); improved depression knowledge, quality of life, behavioral activation, and anxiety (P < 0.001); and improved function (P = 0.014) compared with wait-list participants. More intervention than wait-list participants entered remission at 4 months (43.8% vs. 26.9%). After treatment, control participants showed benefits similar in magnitude to those of participants in the initial intervention group. Those in the initial intervention group maintained benefits at 8 months.
The study had a small sample, short duration, and differential withdrawal rate.
A home-based intervention delivered by social workers could reduce depressive symptoms and enhance quality of life in most older African Americans.
Primary Funding Source
National Institute of Mental Health.
PMCID: PMC4091662  PMID: 24026257
3.  A Biobehavioral Home-Based Intervention and the Well-being of Patients With Dementia and Their Caregivers 
Optimal treatment to postpone functional decline in patients with dementia is not established.
To test a nonpharmacologic intervention realigning environmental demands with patient capabilities.
Design, Setting, and Participants
Prospective 2-group randomized trial (Care of Persons with Dementia in their Environments [COPE]) involving patients with dementia and family caregivers (community-living dyads) recruited from March 2006 through June 2008 in Pennsylvania.
Up to 12 home or telephone contacts over 4 months by health professionals who assessed patient capabilities and deficits; obtained blood and urine samples; and trained families in home safety, simplifying tasks, and stress reduction. Control group caregivers received 3 telephone calls and educational materials.
Main Outcome Measures
Functional dependence, quality of life, frequency of agitated behaviors, and engagement for patients and well-being, confidence using activities, and perceived benefits for caregivers at 4 months.
Of 284 dyads screened, 270 (95%) were eligible and 237 (88%) randomized. Data were collected from 209 dyads (88%) at 4 months and 173 (73%) at 9 months. At 4 months, compared with controls, COPE patients had less functional dependence (adjusted mean difference, 0.24; 95% CI, 0.03–0.44; P=.02; Cohen d=0.21) and less dependence in instrumental activities of daily living (adjusted mean difference, 0.32; 95% CI, 0.09–0.55; P=.007; Cohen d=0.43), measured by a 15-item scale modeled after the Functional Independence Measure; COPE patients also had improved engagement (adjusted mean difference, 0.12; 95% CI, 0.07–0.22; P=.03; Cohen d=0.26), measured by a 5-item scale. COPE caregivers improved in their well-being (adjusted mean difference in Perceived Change Index, 0.22; 95% CI, 0.08–0.36; P=.002; Cohen d=0.30) and confidence using activities (adjusted mean difference, 0.81; 95% CI, 0.30–1.32; P=.002; Cohen d=0.54), measured by a 5-item scale. By 4 months, 64 COPE dyads (62.7%) vs 48 control group dyads (44.9%) eliminated 1 or more caregiver-identified problems (χ12=6.72, P=.01).
Among community-living dyads, a nonpharmacologic biobehavioral environmental intervention compared with control resulted in better outcomes for COPE dyads at 4 months. Although no group differences were observed at 9 months for patients, COPE caregivers perceived greater benefits.
PMCID: PMC4091681  PMID: 20810376
4.  Validity of the Walking Scale for Spinal Cord Injury and Other Domains of Function in a Multicenter Clinical Trial 
To demonstrate criterion (concurrent and predictive) and construct validity of the Walking Index for Spinal Cord Injury (WISCI) scale and other walking measures in the Spinal Cord Injury Locomotor Trial (SCILT).
Prospective multicenter clinical trial of a walking intervention for patients with acute traumatic spinal cord injury (SCI).
Body weight–supported treadmill training was compared to overground mobility training in 146 patients with incomplete SCI (C4 to L3) enrolled within 8 weeks of onset and treated for 12 weeks. Primary outcome measures were the Functional Independence Measure (FIM), 50-foot walking speed (50FW-S), and 6-minute walking distance (6MW-D), tested 3, 6, and 12 months after entry. Secondary measures were the Lower Extremity Motor Score (LEMS), Berg Balance Scale (BBS), WISCI, and FIM locomotor score (LFIM), assessed at 6 centers by blinded observers. Data for the 2 arms were combined since no significant differences in outcomes had been found.
Correlations with WISCI at 6 months were significant with BBS (r = .90), LEMS (r = .85), LFIM (r = .89), FIM (r = .77), 50FW-S (r = .85), and 6MW-D (r = .79); similar correlations occurred at 3 and 12 months. Correlations of change scores from baseline WISCI were significant for change scores from baseline of LEMS/BBS/LFIM. Correlation of baseline LEMS and WISCI at 12 months were most significant (r = .73). The R2 of baseline LEMS explained 57% of variability of WISCI levels at 3 months.
Concurrent validity of the WISCI scale was supported by significant correlations with all measures at 3, 6, and 12 months. Correlation of change scores supports predictive validity. The LEMS at baseline was the best predictor of the WISCI score at 12 months and explained most of the variance, which supported both predictive and construct validity. The combination of the LEMS, BBS, WISCI, 50FW-S, and LFIM appears to encompass adequate descriptors for outcomes of walking trials for incomplete SCI.
PMCID: PMC4080923  PMID: 17507642
Spinal cord injuries; Ambulation; Outcome assessment; Validity
5.  Identification of and Beliefs about Depressive Symptoms and Preferred Treatment Approaches Among Community-living Older African Americans 
To examine older African American’s recognition of and beliefs about depressive symptoms, preferred symptom management strategies, and factors associated with willingness to use mental health treatments. Differences between depressed and non-depressed and men and women were examined.
Cross-sectional survey.
Home, senior center.
153 senior center members (56=males, 97=females) ≥55 years.
Using a depression vignette, participants indicated if the person was depressed and their endorsement of items reflecting beliefs, stigma, symptom management, and willingness to use treatments (yes/no). PHQ-9 assessed current symptomatology.
Overall, 24.2% reported depressive symptoms (≥5); 88.2% correctly identified the person in the vignette as depressed. Most (≥75%) endorsed active symptom management strategies, preference for treatment in physician and therapist offices, and willingness to take medications, seek therapy, see doctor and attend support groups; <33% viewed depression as stigmatizing whereas 48% viewed depression as normal aging. Logistic regressions revealed lower education, higher physical function and feeling okay if community knew of depression diagnosis were associated with willingness to see physician if feeling depressed; being married and believing anti-depressant medications are beneficial were related to willingness to use medications. Different associations emerged for depressed/non-depressed and men and women.
Overall, this older African American sample had positive attitudes and beliefs and endorsed traditional treatment modalities suggesting that beliefs alone are unlikely barriers to underutilization of mental health services. As different factors were associated with willingness to seek physician help and use medications and factors differed for depressed/non-depressed and by sex, interventions should be tailored.
PMCID: PMC4030409  PMID: 22643600
Depression; health disparities; depression beliefs
6.  Toward Global Standards for Comparator Pharmaceutical Products: Case Studies of Amoxicillin, Metronidazole, and Zidovudine in the Americas 
The AAPS Journal  2012;14(3):462-472.
This study compared in vitro dissolution characteristics and other quality measures of different amoxicillin, metronidazole, and zidovudine products purchased in the Americas to a comparator pharmaceutical product (CPP). These three drugs are classified as Biopharmaceutics Classification System Class I drugs with the possibility that dissolution findings might be used to document bioequivalence. All investigated zidovudine products were found to be in vitro equivalent to the CPP. Only 3 of 12 tested amoxicillin products were found to be in vitro equivalent to the CPP. None of the tested metronidazole products were in vitro equivalent to the CPP. These findings suggest but do not confirm bioinequivalence where in vitro comparisons failed, given that an in vivo blood level study might have confirmed bioequivalence. At times, identifying a CPP in one of the selected markets proved difficult. The study demonstrates that products sold across national markets may not be bioequivalent. When coupled with the challenge of identifying a CPP in different countries, the results of this study suggest the value of an international CPP as well as increased use of BCS approaches as means of either documenting bioequivalence or signaling the need for further in vivo studies. Because of increased movement of medicines across national borders, practitioners and patients would benefit from these approaches.
Electronic supplementary material
The online version of this article (doi:10.1208/s12248-012-9350-9) contains supplementary material, which is available to authorized users.
PMCID: PMC3385829  PMID: 22528504
bioequivalence; Biopharmaceutics Classification System; comparator pharmaceutical products; equivalence; standards
7.  Two-stage hierarchical modeling for analysis of subpopulations in conditional distributions 
Journal of applied statistics  2011;39(2):445-460.
In this work, we develop modeling and estimation approach for the analysis of cross-sectional clustered data with multimodal conditional distributions where the main interest is in analysis of subpopulations. It is proposed to model such data in a hierarchical model with conditional distributions viewed as finite mixtures of normal components. With a large number of observations in the lowest level clusters, a two-stage estimation approach is used. In the first stage, the normal mixture parameters in each lowest level cluster are estimated using robust methods. Robust alternatives to the maximum likelihood estimation are used to provide stable results even for data with conditional distributions such that their components may not quite meet normality assumptions. Then the lowest level cluster-specific means and standard deviations are modeled in a mixed effects model in the second stage. A small simulation study was conducted to compare performance of finite normal mixture population parameter estimates based on robust and maximum likelihood estimation in stage 1. The proposed modeling approach is illustrated through the analysis of mice tendon fibril diameters data. Analyses results address genotype differences between corresponding components in the mixtures and demonstrate advantages of robust estimation in stage 1.
PMCID: PMC3329128  PMID: 22523443
Robust finite normal mixture; Weighted likelihood estimator; Hierarchical models; Mixed effects models; Two-stage estimation
8.  Targeting and Managing Behavioral Symptoms in Individuals with Dementia: A Randomized Trial of a Nonpharmacologic Intervention 
Test effects of an intervention that helps families manage distressful behaviors.
Two-group randomized trial
272 caregivers and dementia patients
Up to 11 home/telephone contacts over 16-weeks by health professionals who identified potential triggers of patient behaviors including communication, environment, patient undiagnosed medical conditions (by obtaining blood/urine samples), and trained caregivers in strategies to modify triggers and reduce caregiver upset. Between 16–24 weeks, 3 telephone contacts reinforced strategy use.
Primary outcomes included frequency of targeted problem behavior, and caregiver upset with and confidence managing it at 16-weeks. Secondary outcomes included caregiver well-being and management skills at 16 and 24 weeks, and caregiver perceived benefits. Prevalence of medical conditions for intervention patients were also examined.
At 16 weeks, 67.5% of intervention caregivers reported patient improvement in targeted problem behavior compared to 45.8% of caregivers in a no-treatment control group (p=.002), reduced upset with (p=.028) and enhanced confidence managing (p=.011) the behavior. Additionally, compared to controls, intervention caregivers reported less upset with all problem behaviors (p=.001), negative communication (p=.017), burden (p=.051), and improved well-being (p=.001). Fewer intervention caregivers had depressive symptoms (53.0%) than control group caregivers (67.8%, p=.020). Similar caregiver outcomes occurred at 24-weeks. Compared to controls, intervention caregivers perceived more study benefits (p values <.05) including ability to keep patients home. Blood/urine samples of intervention patients showed 40 (34.1%) had undiagnosed illnesses requiring physician follow-up.
Targeting behaviors upsetting to caregivers and modifying potential triggers improves patient symptomatology and caregiver well-being and skills.
PMCID: PMC2955191  PMID: 20662955
Quality of life; neuropsychiatric behaviors; dementia; caregiving; environmental modification
9.  Depressive Symptoms in Older African-American and White Adults with Functional Difficulties: The Role of Control Strategies 
To examine whether control-oriented strategies buffer effects of functional difficulties on depressive symptoms over time in older African-American and white adults with disability.
Community-based, prospective study.
Baseline and 12-month data from a randomized trial.
One hundred twenty-nine African-American and 151 white older adults with 12-month data from 319 participants in the trial.
Data were obtained for functional difficulties, the extent that respondents reported using control (cognitive and behavioral) strategies to enhance and maintain independence, and baseline and 12-month depressive symptoms (Center for Epidemiologic Studies Depression Scale; CES-D).
African Americans reported greater baseline functional difficulty (P = .009), fewer depressive symptoms (P = .002) and higher control strategy use (P = .001) than whites. Functional difficulty was associated with depressive symptoms for both groups at baseline and 12 months. Living alone for whites and low spirituality for African Americans predicted higher 12-month depressive symptom scores. African Americans with baseline functional difficulty and high strategy use had lower 12-month depression than those with similar difficulty levels but low strategy use (P = .04 for interaction), representing a 28.5-point CES-D score differential. Control strategies did not buffer the function–depression relationship over time for whites.
Control-oriented strategies moderated the experience of depressive symptomatology over time for African Americans with disability but not for whites. This may explain the paradox of greater functional disparities but less reported emotional distress in African Americans than whites. Results suggest that the use and benefits of adaptive resources to attain functional goals and determinants of depression differ by race. Depression prevention programs should be modified to be suitable for different cultural groups
PMCID: PMC2907298  PMID: 17608874
disability; aging in place; late-life mental disorder
10.  Long-term Effect on Mortality of a Home Intervention that Reduces Functional Difficulties in Older Adults: Results from a Randomized Trial1 
To evaluate long-term mortality effects of a home-based intervention previously shown to reduce functional difficulties, and whether survivorship benefits differed by risk level.
Two-group randomized trial with survivorship followed up to 4 years from study entry.
Homes of urban community-living elders.
319 adults 70+ years with difficulties performing daily activities.
Occupational and physical therapy sessions to instruct participants in compensatory strategies, home modifications, safety, fall recovery techniques, and balance and muscle strength exercises.
Survival time was number of days between baseline interview and date of death as determined by data from the National Death Index or December 31, 2005. Participants were stratified by baseline mortality risk (low, moderate, high) using a prognostic indicator.
At two years, intervention participants (n=160) had a 5.6% mortality rate (n=9 deaths) and controls (n=159) a 13.2% rate (n=21 deaths; p=.020). Mortality rates remained relatively lower for intervention participants up to 3.5 years from study entry. At two years, intervention participants with moderate mortality risk had a 16.7% mortality rate (n=16 deaths/96) compared to 28.2% for equivalent control group participants (n=24 deaths/85; p=.021). By three years, mortality rates were not statistically significantly different between experimental and control groups.
The intervention extended survivorship up to 3.5 years, and maintained statistically significant differences for two years. Those at moderate mortality risk derived the most intervention benefit. Findings suggest that the intervention could be a low-cost clinical tool to delay both functional decline and mortality.
PMCID: PMC2712136  PMID: 19187417
Home care; frailty; survivorship; occupational therapy; physical therapy
11.  Change in Criteria for USP Dissolution Performance Verification Tests 
AAPS PharmSciTech  2009;10(1):21-26.
The US Pharmacopeial Convention has been evaluating its performance verification tests (PVT) for several years. These tests help ensure the integrity of the US Pharmacopeia performance test when a dissolution procedure, as described in General Chapter Dissolution <711>, is relied upon to test a nonsolution orally administered dosage form. One result of the evaluation is a change in the PVT criterion from one based on individual tablet results to one based on the mean and variability of a set of tablets. This paper describes the new PVT and its criterion and how its acceptance limits are derived from results of a collaborative study, explains a two-stage option for the test, and presents operating characteristics.
PMCID: PMC2663662  PMID: 19132536
acceptance criteria; data analysis; dissolution test; performance verification test; reference standards
12.  Tailored Activities to Manage Neuropsychiatric Behaviors in Persons with Dementia and Reduce Caregiver Burden: A Randomized Pilot Study 
To test whether the Tailored Activity Program for at-home dementia patients reduces neuropsychiatric behaviors and caregiver burden.
A prospective, two-group controlled pilot study with 60 dyads randomized to treatment or wait-list control. Dyads were interviewed at baseline and 4 months (trial endpoint); control participants then received intervention and were reassessed 4 months later. The 8-session occupational therapy intervention involved neuropsychological and functional testing from which activities were customized and instruction in use provided to caregivers.
At 4-months, compared to controls, intervention caregivers reported reduced frequency of behaviors (p = .010; Cohen’s d = .72), specifically for shadowing (p = .003, Cohen’s d = 3.10) and repetitive questioning (p = .23, Cohen’s d = 1.22); greater activity engagement (p = .029, Cohen’s d = .61); and ability to keep busy (p = .017, Cohen’s d = .71). Also, fewer intervention caregivers reported agitation (p = .014, Cohen’s d = .75) or argumentation (p = .010, Cohen’s d = .77). Caregiver benefits included fewer hours doing things (p = .005, Cohen’s d = 1.14) and being on duty (p = .001, Cohen’s d = 1.01), greater mastery (p = .013, Cohen’s d = .55), self-efficacy (p = .011, Cohen’s d = .74), and use of simplification techniques (p = .023, Cohen’s d = .71). Wait-list control participants showed similar benefits for behavioral frequency following intervention.
Results suggest clinically-relevant benefits for both dementia patients and caregivers, with treatment minimizing the occurrence of behaviors that commonly trigger nursing home placement.
PMCID: PMC2803044  PMID: 18310553
Dementia caregiving; Activity engagement; Disruptive behaviors
13.  A Non-pharmacological Intervention to Manage Behavioral and Psychological Symptoms of Dementia and Reduce Caregiver Distress: Design and Methods of Project ACT1 
Clinical interventions in aging  2007;2(4):695-703.
Project ACT is a randomized controlled trial designed to test the effectiveness of a non-pharmacological home-based intervention to reduce behavioral and psychological symptoms of dementia (BPSD) and caregiver distress. The study targets 272 stressed racially diverse family caregivers providing in-home care to persons with moderate stage dementia with one or more behavioral disturbances. All participants are interviewed at baseline, 4 months (main trial endpoint), and 6 months (maintenance). The four-month intervention involves up to 13 visits from an occupational therapist who works with families to problem-solve potential triggers (communication style, environmental clutter) contributing to behaviors, and instruct in strategies to reduce caregiver stress and manage targeted behaviors. To rule out infection or other potential medical contributors to behaviors, a nurse obtains blood and urine samples from the dementia patient, and conducts a medication review. Participants in the no-treatment control group are offered the nurse arm and one in-home session following trial completion at 6-months. This paper describes the research methods, theoretical and clinical aspects of this multi-component, targeted psycho-social treatment approach, and the measures used to evaluate quality of life improvements for persons with dementia and their families.
PMCID: PMC2670989  PMID: 18225471
family caregiving; environmental modification; home care; occupational therapy; psychosocial intervention
14.  Variation in Response to a Home Intervention to Support Daily Function by Age, Race, Sex, and Education 
Functional difficulty is associated with increased frailty and poor life quality, with the oldest old, women, African Americans and less educated at greatest risk of disablement. This study examines whether these at-risk groups benefit differentially from an in-home intervention previously found to effectively reduce functional difficulties.
319 community-living functionally vulnerable adults 70 years or older were randomized to usual care or an intervention involving occupational and physical therapy home instruction in problem-solving, device use, energy conservation, safety, fall recovery, balance and muscle strengthening instruction. Outcome measures at six and 12 months included difficulty level in ambulation, instrumental (IADLs) and activities of daily living (ADLs), self-efficacy, and fear of falling.
At six-months, for ADLs, individuals ≥80 years (p=.022), women (p=.036), and less educated (p=.028) intervention participants improved compared to their control group counterparts. For mobility, women (p=.048) and the oldest (p=.001) intervention participants improved relative to their counterparts. For self-efficacy, women (p=.036) and less educated (p=.016) intervention participants benefited more. For fear of falling, those less educated improved more (p=.001). A similar pattern was found at 12 months. For IADLs, Whites improved more than non-Whites at 12 months.
Treatment benefits varied by specific participant characteristics, with individuals at greatest disability riskbeing most responsive to the intervention. Both White and non-White participants benefited similarly except in IADL functioning. Future research should control for participant characteristics, identify underlying mechanisms for variation in treatment effects, and tailor treatment to patient characteristics and desired outcomes.
PMCID: PMC2656911  PMID: 18693230
Home modification; disability; frailty
15.  Dissolution Variability: Comparison of Commercial Dosage Forms with US Pharmacopeia Lot P Prednisone Reference Standard Tablets—A Technical Note 
AAPS PharmSciTech  2008;9(1):238-242.
PMCID: PMC2976897  PMID: 18446487
apparatus qualification; dissolution testing; reference standard tablets
16.  A non-pharmacological intervention to manage behavioral and psychological symptoms of dementia and reduce caregiver distress: Design and methods of project ACT3 
Clinical Interventions in Aging  2007;2(4):695-703.
Project ACT is a randomized controlled trial designed to test the effectiveness of a non-pharmacological home-based intervention to reduce behavioral and psychological symptoms of dementia (BPSD) and caregiver distress. The study targets 272 stressed racially diverse family caregivers providing in-home care to persons with moderate stage dementia with one or more behavioral disturbances. All participants are interviewed at baseline, 4-months (main trial endpoint), and 6-months (maintenance). The four-month intervention involves up to 13 visits from an occupational therapist who works with families to problem-solve potential triggers (communication style, environmental clutter) contributing to behaviors, and instruct in strategies to reduce caregiver stress and manage targeted behaviors. To rule out infection or other potential medical contributors to behaviors, a nurse obtains blood and urine samples from the dementia patient, and conducts a medication review. Participants in the no-treatment control group are offered the nurse arm and one in-home session following trial completion at 6-months. This paper describes the research methods, theoretical and clinical aspects of this multi-component, targeted psycho-social treatment approach, and the measures used to evaluate quality of life improvements for persons with dementia and their families.
PMCID: PMC2670989  PMID: 18225471
family caregiving; environmental modification; home care; occupational therapy; psychosocial intervention
17.  Physician and Patient Factors Associated with Ordering a Colon Evaluation After a Positive Fecal Occult Blood Test 
Successful colorectal cancer screening relies in part on physicians ordering a complete diagnostic evaluation of the colon (CDE) with colonoscopy or barium enema plus sigmoidoscopy after a positive screening fecal occult blood test (FOBT).
We surveyed primary care physicians about colorectal cancer screening practices, beliefs, and intentions. At least 1 physician responded in 318 of 413 (77%) primary care practices that were affiliated with a managed care organization offering a mailed FOBT program for patients aged ≥50 years. Of these 318 practices, 212 (67%) had 602 FOBT+ patients from August through November 1998. We studied 184 (87%) of these 212 practices with 490 FOBT+ patients after excluding those judged ineligible for a CDE or without demographic data. Three months after notification of the FOBT+ result, physicians were asked on audit forms if they had ordered CDEs for study patients. Patient- and physician-predictors of ordering CDEs were identified using logistic regression.
A CDE was ordered for only 69.5% of 490 FOBT+ patients. After adjustment, women were less likely to have had CDE initiated than men (adjusted odds, 0.66; confidence interval, 0.44 to 0.97). Physician survey responses indicating intermediate or high intention to evaluate a FOBT+ patient with a CDE were associated with nearly 2-fold greater adjusted odds of actually initiating a CDE in this circumstance versus physicians with a low intention.
Primary care physicians often fail to order CDE for FOBT+ patients. A CDE was less likely to be ordered for women and was influenced by physician's beliefs about CDEs.
PMCID: PMC1494867  PMID: 12795734
colorectal neoplasms; primary health care; occult blood; mass screening; attitude of health personnel
18.  Relationship of Gender, Depression, and Health Care Delivery With Antiretroviral Adherence in HIV-infected Drug Users 
Antiretroviral adherence is worse in women than in men, and depression can influence medication adherence.
To evaluate the relationship of gender, depression, medical care, and mental health care to adherence in HIV-infected drug users.
Retrospective cohort study.
New York State Medicaid program.
One thousand eight hundred twenty-seven female and 3,246 male drug users on combination antiretroviral therapy for more than 2 months in 1997.
A pharmacy-based measure of adherence was defined as ≥95% days covered by at least 2 prescribed antiretroviral drugs. Independent variables were: depression, regular drug treatment (≥6 months), regular medical care (2+ and >35% of visits), HIV-focused care (2+ visits), psychiatric care (2+ visits), and antidepressant therapy.
Women were less adherent than men (18% vs 25%, respectively, P < .001) and more likely to be diagnosed with depression (34% vs 29%). In persons with depression, the adjusted odds ratio (AOR) for adherence was greater for those with psychiatric care alone (AOR 1.52; 95% confidence interval [95% CI], 1.03 to 2.26) or combined with antidepressants (AOR 1.49; 95% CI, 1.04 to 2.15). In separate models by gender in persons with depression, psychiatric care plus antidepressants had a slightly stronger association with adherence in women (AOR 1.92; 95% CI, 1.00 to 3.68) than men (AOR, 1.26; 95% CI, 0.81 to 1.98). In drug users without depression, antidepressants alone were associated with greater adherence (AOR, 1.23; 95% CI, 1.02 to 1.49) with no difference by gender. Regular drug treatment was positively associated with adherence only in men.
In this drug-using cohort, women had worse pharmacy-measured antiretroviral adherence than men. Mental health care was significantly associated with adherence in women, while regular drug treatment was positively associated with adherence in men.
PMCID: PMC1494846  PMID: 12709091
HIV infection; antiretroviral therapy; adherence; compliance; mental health services
19.  The effect of ethnicity and maternal birthplace on small-for-gestational-age deliveries to HIV-infected women 
To examine the relative role of ethnicity and maternal birthplace on small-for-gestational-age (SGA) deliveries of a cohort of mothers in New York who were infected with human immunodeficiency virus.
Medicaid claims and linked vital statistics records were examined for 2,525 singleton deliveries to HIV-infected women from 1993 through 1996. We estimated adjusted odds ratios (AORs) and 95% confidence intervals (CIs) of SGA delivery associated with ethnicity (i.e., white, white-Latina, black, and black-Latina) and maternal birthplace (i.e., native US/Puerto Rican vs. foreign born) in a series of multivariate regression models to which we sequentially added demographic, health services, and lifestyle factors (i.e., alcohol, tobacco, and illicit drug use).
Of the deliveries, 10% were SGA. The odds of SGA infants for black and white women did not differ by maternal birthplace. Foreign-born white-Latinas and black-Latinas had lower unadjusted odds of a SGA delivery than their US-born counterparts (OR 0.29, CI 0.14, 0.61 and OR 0.22, CI 0.07, 0.71, respectively). After adjustment for maternal lifestyle characteristics, the odds of SGA delivery were 0.50 (CI 0.23, 1.09) for white-Latina mothers and 0.60 (CI 0.17, 2.08) for black-Latina mothers.
SGA outcomes did not differ by maternal birthplace for black and white women. Differences in lifestyle factors appear to contribute to lower odds of SGA delivery for foreign-born versus US-born white- and black-Latina HIV-infected women.
PMCID: PMC3456377  PMID: 11937623
African American; Hispanic American; HIV Infection; Medicaid; Small for Gestational Age; Substance Abuse-Related Disorders
20.  Clinic characteristics associated with reduced hospitalization of druc users with aids 
To identify features of ambulatory care associated with reduced hospitalization among drug users with acquired immunodeficiency syndrome (AIDS).
A nonconcurrent prospective study of hospital use by 1,369 drug users with AIDS was conducted using data from New York State Medicaid research data files linked to telephone interview data from directors of ambulatory care clinics serving this group.
Follow-up averaged 29 months, during which 88% of subjects were hospitalized at least once. On average, those hospitalized spent 14% of follow-up time as inpatients. Hospitalization was less likely for patients in clinics with case managers (adjusted odds ratio=0.42, 95% confidence interval 0.25, 0.68) or high director’s rating of coordination of care (adjusted odds ratio=0.50, 95% confidence interval 0.29, 0.89). Multivariate analysis showed significantly less time in hospital for patients in clinics with methadone maintenance, case managers, high continuity ratings, and clinic physicians attending for hospitalized clinic patients.
Drug users with AIDS rely heavily on inpatient care, but those followed in clinics featuring greater coordination and offering special services, including methadone treatment and case management, appear to have significantly less hospital use.
PMCID: PMC3456288  PMID: 9663974
Acquired immunodeficienty syndrome; Substance abuse; Hospitalization; Ambulatory care
21.  Clinic HIV-Focused Features and Prevention of Pneumocystis Carinii Pneumonia 
To examine the association of clinic HIV-focused features and advanced HIV care experience with Pneumocystis carinii pneumonia (PCP) prophylaxis and development of PCP as the initial AIDS diagnosis.
Nonconcurrent prospective study.
New York State Medicaid Program.
Medicaid enrollees diagnosed with AIDS in 1990–1992.
We collected patient clinical and health care data from Medicaid files, conducted telephone interviews of directors of 125 clinics serving as the usual source of care for study patients, and measured AIDS experience as the cumulative number of AIDS patients treated by the study clinics since 1986. Pneumocystis carinii pneumonia prophylaxis in the 6 months before AIDS diagnosis and PCP at AIDS diagnosis were the main outcome measures. Bivariate and multivariate analyses adjusted for clustering of patients within clinics. Of 1,876 HIV-infected persons, 44% had PCP prophylaxis and 38% had primary PCP. Persons on prophylaxis had 20% lower adjusted odds of developing PCP (95% confidence interval [CI] 0.64, 0.99). The adjusted odds of receiving prophylaxis rose monotonically with the number of HIV-focused features offered by the clinic, with threefold higher odds (95% CI 1.6, 5.7) for six versus two or fewer such features. Patients in clinics with three HIV-focused features had 36% lower adjusted odds of PCP than those in clinics with one or none. Neither clinic experience nor specialty had a significant association with prophylaxis or PCP.
PCP prevention in our study cohort appears to be more successful in clinics offering an array of HIV-focused features.
PMCID: PMC1496898  PMID: 9462490
Pneumocystis carinii pneumonia (PCP); AIDS; clinical competence; ambulatory care; case management

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