The disproportionately high prevalence of hypertension and its associated mortality and morbidity in minority older adults is a major public health concern in the United States. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes on blood pressure reduction, these approaches remain largely untested among minority elders in community-based settings. The Counseling Older Adults to Control Hypertension trial is a two-arm randomized controlled trial of 250 African-American and Latino seniors, 60 years and older with uncontrolled hypertension, who attend senior centers. The goal of the trial is to evaluate the effect of a therapeutic lifestyle intervention delivered via group classes and individual motivational interviewing sessions versus health education, on blood pressure reduction. The primary outcome is change in systolic and diastolic blood pressure from baseline to 12 months. The secondary outcomes are blood pressure control at 12 months; changes in levels of physical activity; body weight; and number of daily servings of fruits and vegetables from baseline to 12 months. The intervention group will receive 12 weekly group classes followed by individual motivational interviewing sessions. The health education group will receive an individual counseling session on healthy lifestyle changes and standard hypertension education materials. Findings from this study will provide needed information on the effectiveness of lifestyle interventions delivered in senior centers. Such information is crucial in order to develop implementation strategies for translation of evidence-based lifestyle interventions to senior centers, where many minority elders spend their time, making the centers a salient point of dissemination.
Hypertension; Minority Elders; Senior Centers; Therapeutic Lifestyle Changes
To assess the association between serum adiponectin level and all-cause mortality in people with type 2 diabetes. Because of the insulin-sensitizing, anti-inflammatory, and antiatherogenic effects of adiponectin, we hypothesized that higher adiponectin level would be associated with lower all-cause mortality.
RESEARCH DESIGN AND METHODS
A total of 609 men and women aged 72 ± 6.3 years with type 2 diabetes and information on total and high molecular weight adiponectin were followed for a median of 5 years. The longitudinal association between adiponectin and all-cause mortality was analyzed with Cox proportional hazards models with time from adiponectin measurement to death as the time-to-event variable. Analyses were adjusted for demographic variables and significant diabetes parameters, significant cardiovascular parameters, and significant diabetes medications.
Total and high molecular weight adiponectin were highly correlated. The highest adiponectin quartile was strongly associated with higher all-cause mortality compared with the lowest quartile (hazard ratio = 4.0 [95% CI: 1.7–9.2]) in the fully adjusted model. These results did not change in analyses stratified by sex and thiazolidinedione use, after exclusion of people who died within one year of adiponectin measurement, or when change in weight before adiponectin measurement was considered.
Contrary to our hypothesis, higher adiponectin level was related to higher all-cause mortality. This association was not explained by confounding by other characteristics, including medications or preceding weight loss.
To examine the effects of electronic health information technology (HIT) on nursing home residents.
The study evaluated the impact of implementing a comprehensive HIT system on resident clinical, functional, and quality of care outcome indicators, as well as measures of resident awareness of and satisfaction with the technology. The study used a prospective, quasi-experimental design, directly assessing 761 nursing home residents in 10 urban and suburban nursing homes in the greater New York City area.
No statistically significant impact of the introduction of HIT on residents was found on any outcomes, with the exception of a significant negative effect on behavioral symptoms. Residents' subjective assessment of the HIT intervention were generally positive.
The absence of effects on most indicators is encouraging for the future development of HIT in nursing homes. The single negative finding suggests that further investigation is needed on possible impact on resident behavior.
Long-Term Care; Technology; Quality of Care
Elder abuse in long term care has received considerable attention; however, resident-to-resident elder mistreatment (R-REM) has not been well researched. Preliminary findings from studies of R-REM suggest that it is sufficiently widespread to merit concern, and is likely to have serious detrimental outcomes for residents. However, no evidence-based training, intervention and implementation strategies exist that address this issue.
The objective was to evaluate the impact of a newly developed R-REM training intervention for nursing staff on knowledge, recognition and reporting of R-REM.
The design was a prospective cluster randomized trial with randomization at the unit level.
A sample of 1405 residents (685 in the control and 720 in the intervention group) from 47 New York City nursing home units (23 experimental and 24 control) in 5 nursing homes was assessed. Data were collected at three waves: baseline, 6 and 12 months. Staff on the experimental units received the training and implementation protocols, while those on the comparison units did not. Evaluation of outcomes was conducted on an intent-to-treat basis using mixed (random and fixed effects) models for continuous knowledge variables and Poisson regressions for longitudinal count data measuring recognition and reporting.
There was a significant increase in knowledge post-training, controlling for pre-training levels for the intervention group (p<0.001), significantly increased recognition of R-REM (p<0.001), and longitudinal reporting in the intervention as contrasted with the control group (p=0.0058).
A longitudinal evaluation demonstrated that the training intervention was effective in enhancing knowledge, recognition and reporting of R-REM. It is recommended that this training program be implemented in long term care facilities.
Resident-to-resident elder mistreatment (R-REM); nursing homes; long term care; older people; elder abuse; staff education; staff training
Object naming tests are commonly included in neuropsychological test batteries. Differential item functioning (DIF) in these tests due to cultural and language differences may compromise the validity of cognitive measures in diverse populations. We evaluated 26 object naming items for DIF due to Spanish and English language translations among Latinos (n=1,159), mean age of 70.5 years old (Standard Deviation (SD)±7.2), using the following four item response theory-based approaches: Mplus/Multiple Indicator, Multiple Causes (Mplus/MIMIC; Muthén & Muthén, 1998–2011), Item Response Theory Likelihood Ratio Differential Item Functioning (IRTLRDIF/MULTILOG; Thissen, 1991, 2001), difwithpar/Parscale (Crane, Gibbons, Jolley, & van Belle, 2006; Muraki & Bock, 2003), and Differential Functioning of Items and Tests/MULTILOG (DFIT/MULTILOG; Flowers, Oshima, & Raju, 1999; Thissen, 1991). Overall, there was moderate to near perfect agreement across methods. Fourteen items were found to exhibit DIF and 5 items observed consistently across all methods, which were more likely to be answered correctly by individuals tested in Spanish after controlling for overall ability.
Item response theory; differential item functioning; object naming test; Hispanic/Latinos; Spanish
Despite its prevalence and negative consequences, research on elder abuse has rarely considered resident-to-resident aggression (RRA) in nursing homes. This study employed a qualitative event reconstruction methodology to identify the major forms of RRA that occur in nursing homes.
Design and methods:
Events of RRA were identified within a 2-week period in all units (n = 53) in nursing homes located in New York City. Narrative reconstructions were created for each event based on information from residents and staff who were involved as well as other sources. The event reconstructions were analyzed using qualitative methods to identify common features of RRA events.
Analysis of the 122 event reconstructions identified 13 major forms of RRA, grouped under five themes. The resulting framework demonstrated the heterogeneity of types of RRA, the importance of considering personal, environmental, and triggering factors, and the potential emotional and physical harm to residents.
These results suggest the need for person-centered and environmental interventions to reduce RRA, as well as for further research on the topic.
Abuse/neglect; Behavior; Long-term care; Aggression
A randomized controlled trial examined whether the diagnostic process for Alzheimer’s disease and other dementias may be influenced by knowledge of the patient’s education and/or self-reported race. Four conditions were implemented: diagnostic team knows (a) race and education, (b) education only, (c) race only, or (d) neither. Diagnosis and clinical staging was established at baseline, at Wave 2, and for a random sample of Wave 3 respondents by a consensus panel. At study end, a longitudinal, “gold standard” diagnosis was made for patients with follow-up data (71%). Group differences in Diagnostic and Statistical Manual of Mental Disorders (4th ed.; American Psychiatric Association, 1994) diagnosis were estimated using logistic regression and generalized estimating equations. Sensitivity and specificity were examined for baseline diagnosis in relation to the gold standard, longitudinal diagnosis. Despite equivalent status on all measured variables across waves, members of the “knows race only” group were less likely than those of other groups to receive a diagnosis of dementia. At final diagnosis, 19% of the “knows race only” group was diagnosed with dementia versus 38% to 40% in the other 3 conditions (p = .038). Examination of sensitivities and specificities of baseline diagnosis in relation to the gold standard diagnosis showed a nonsignificant trend for lower sensitivities in the knowing race conditions (0.3846), as contrasted with knowing education only (0.480) or neither (0.600). The finding that knowledge of race may influence the diagnostic process in some unknown way is timely, given the recent State-of-the-Science conference on Alzheimer’s disease prevention, the authors of which called for information about and standardization of the diagnostic process.
Alzheimer’s disease; clinical diagnosis; bias; self-reported race; education
In 2002, the NIH launched the ‘Roadmap for Medical Research’. The Patient-Reported Outcomes Measurement Information System (PROMIS®) is one of the Roadmap’s key aspects. To create the next generation of patient-reported outcome measures, PROMIS utilizes item response theory (IRT) and computerized adaptive testing. In 2009, the NIH funded the second wave of PROMIS studies (PROMIS II). PROMIS II studies continue PROMIS’s agenda, but also include new features, including longitudinal analyses and more sociodemographically diverse samples. PROMIS II also includes increased emphasis on pediatric populations and evaluation of PROMIS item banks for clinical research and population science. These aspects bring new psychometric challenges. To address this, investigators associated with PROMIS gathered at the Third Psychometric Summit in September 2010 to identify, describe and discuss pressing psychometric issues and new developments in the field, as well as make analytic recommendations for PROMIS. The summit addressed five general themes: linking, differential item functioning, dimensionality, IRT models for longitudinal applications and new IRT software. In this article, we review the discussions and presentations that occurred at the Third PROMIS Psychometric Summit.
computerized adaptive testing; dimensionality; factor analysis; item response theory; patient-reported outcomes; PROMIS; psychometrics; structural equation modeling
Dementia prevalence and its burden on families are increasing. Caregivers of persons with dementia have more depression and stress than the general population. Several interventions have proven efficacy in decreasing depression and stress in selected populations of caregivers. Hispanics in New York City tend to have a higher burden of dementia caregiving compared to non-Hispanic whites (NHW) because Hispanics have a higher prevalence of dementia, tend to have high family involvement, and tend to have higher psychosocial and economic stressors. Thus, we chose to test the effectiveness of a dementia caregiving intervention, the New York University Caregiver Intervention (NYUCI), with demonstrated efficacy in spouse caregivers in Hispanic relative caregivers of persons with dementia. Including the community health worker (CHW) intervention in both arms alleviates general psychosocial stressors and allows the assessment of the effectiveness of the intervention. Compared to two original efficacy studies of the NYUCI, which included only spouse caregivers, our study includes all relative caregivers, including common law spouses, children, siblings, a nephew and nieces. This study will be the first randomised trial to test the effectiveness of the NYUCI in Hispanic caregivers including non-spouses.
Methods and analysis
The design of the study is a randomised controlled trial (RCT). Participants are randomised to two arms: case management by a CHW and an intervention arm including the NYUCI in addition to case management by the CHW. The duration of intervention is 6 months. The main outcomes in the trial are changes in the Geriatric Depression Scale (GDS) and the Zarit Caregiver Burden Scale (ZCBS) from baseline to 6 months.
Ethics and dissemination
This trial is approved by the Columbia University Medical Center Institutional Review Board (AAAI0022), and funded by the National Institute on Minority Health and Health Disparities. The funding agency has no role in dissemination.
Differential item functioning (DIF) occurs when a test item has different statistical properties in subgroups, controlling for the underlying ability measured by the test. DIF assessment is necessary when evaluating measurement bias in tests used across different language groups. However, other factors such as educational attainment can differ across language groups, and DIF due to these other factors may also exist. How to conduct DIF analyses in the presence of multiple, correlated factors remains largely unexplored. This study assessed DIF related to Spanish versus English language in a 44-item object naming test. Data come from a community-based sample of 1,755 Spanish- and English-speaking older adults. We compared simultaneous accounting, a new strategy for handling differences in educational attainment across language groups, with existing methods. Compared to other methods, simultaneously accounting for language- and education-related DIF yielded salient differences in some object naming scores, particularly for Spanish speakers with at least 9 years of education. Accounting for factors that vary across language groups can be important when assessing language DIF. The use of simultaneous accounting will be relevant to other cross-cultural studies in cognition and in other fields, including health-related quality of life.
cognitive testing; item response theory; logistic regression; test bias; translation
to examine whether improved diabetes control is related to better cognitive outcomes.
randomized control trial
a randomized trial of telemedicine vs. usual care in elderly persons with type 2 diabetes.
Participants were 2169 persons 55 years and older with type 2 diabetes from New York City and Upstate New York.
The diabetes case management intervention was implemented by a diabetes nurse, via a telemedicine unit in the participant’s home, and in coordination with the primary care physician.
Hemoglobin A1c (HbA1c), systolic blood pressure (SBP), and low density lipoprotein cholesterol (LDL), were measured at a baseline visit and at up to 5 annual follow-up visits. Global cognition was measured at those visits with the Comprehensive Assessment and Referral Evaluation (CARE).
In mixed models the intervention was related to slower global cognitive decline in the intervention group (p = 0.01). Improvements in HbA1c (p = 0.03), but not SBP or LDL, mediated the effect of the intervention on cognitive decline.
Improved diabetes control in the elderly following existing guidelines through a telemedicine intervention was associated with less global cognitive decline. The main mediator of this effect seemed to be improvements in HbA1c.
Diabetes treatment; cognitive impairment; clinical trials
Hispanics in the USA are affected by the diabetes epidemic disproportionately, and they consistently have lower access to care, poorer control of the disease and higher risk of complications. This study evaluates whether a community health worker (CHW) intervention may improve clinically relevant markers of diabetes care in adult underserved Hispanics.
Methods and analysis
The Northern Manhattan Diabetes Community Outreach Project (NOCHOP) is a two-armed randomised controlled trial to be performed as a community-based participatory research study performed in a Primary Care Setting in Northern Manhattan (New York City). 360 Hispanic adults with poorly controlled type 2 diabetes mellitus (haemoglobin A1c >8%), aged 35–70 years, will be randomised at a 1:1 ratio, within Primary Care Provider clusters. The two study arms are (1) a 12-month CHW intervention and (2) enhanced usual care (educational materials mailed at 4-month intervals, preceded by phone calls). The end points, assessed after 12 months, are primary = haemoglobin A1c and secondary = blood pressure and low-density lipoprotein-cholesterol levels. In addition, the study will describe the CHW intervention in terms of components and intensity and will assess its effects on (1) medication adherence, (2) medication intensification, (3) diet and (4) physical activity.
Ethics and dissemination
All participants will provide informed consent; the study protocol has been approved by the Institutional Review Board of Columbia University Medical Center. CHW interventions hold great promise in improving the well-being of minority populations who suffer from diabetes mellitus. The NOCHOP study will provide valuable information about the efficacy of those interventions vis-à-vis clinically relevant end points and will inform policy makers through a detailed characterisation of the programme and its effects.
Clinical trial registration number
NCT00787475 at clinicaltrials.gov.
Randomised controlled trial.
This community-based participatory research study is a collaboration between a community organisation and a university in Northern Manhattan, New York City.
The goal is to assess whether the CHW worker intervention may improve diabetes care in underserved adult Hispanics from the community.
The primary outcome of interest is haemoglobin A1c, a marker of diabetes control; secondary outcomes are blood pressure and low-density lipoprotein cholesterol levels.
Strengths and limitations of this study
This study will examine effects of the CHW intervention after 12 months, a longer time period than in previous studies.
The CHW intervention protocol was developed in a culturally appropriate manner to address the needs of Hispanics residing in our community.
If proven efficacious, it will warrant examination in other cultural socioeconomic milieus.
The Informatics for Diabetes Education and Telemedicine (IDEATel) project randomized ethnically diverse underserved older adults with diabetes to a telemedicine intervention or usual care. Intervention participants had lower A1C levels over 5 years. New analyses were performed to help better understand this difference.
RESEARCH DESIGN AND METHODS
IDEATel randomized Medicare beneficiaries with diabetes (n = 1,665) to receive home video visits with a diabetes educator and upload glucose levels every 4–6 weeks or usual care (2000–2007). Annual measurements included BMI, A1C (primary outcome), and completion of questionnaires. Mixed-model analyses were performed using random effects to adjust for clustering within primary care physicians.
At baseline, A1C levels (mean ± SD) were 7.02 ± 1.25% in non-Hispanic whites (n = 821), 7.58 ± 1.78% in non-Hispanic blacks (n = 248), and 7.79 ± 1.68% in Hispanics (n = 585). Over time, lower A1C levels were associated with more glucose uploads (P = 0.02) and female sex (P = 0.002). Blacks, Hispanics, and insulin-users had higher A1C levels than non-Hispanic whites (P < 0.0001). BMI was not associated with A1C levels. Blacks and Hispanics had significantly fewer uploads than non-Hispanic whites over time. Hispanics had the highest baseline A1C levels and showed the greatest improvement in the intervention, but, unlike non-Hispanic whites, Hispanics did not achieve A1C levels <7.0% at 5 years.
Racial/ethnic disparities were observed in this cohort of underserved older adults with diabetes. The IDEATel telemedicine intervention was associated with improvement in glycemic control, particularly in Hispanics, who had the highest baseline A1C levels, suggesting that telemedicine has the potential to help reduce disparities in diabetes management.
Caring for persons with diabetes is expensive, and this burden is increasing. Little is known about service use, behaviors, and self-care of older individuals with diabetes who live in underserved communities. Information about self-care, informal care, and service utilization in urban (largely Latino, n = 695) and rural (mostly white, n = 819) Medicare beneficiaries with diabetes living in federally designated medically underserved areas was collected using computer-aided telephone interviews as part of the baseline assessment in the Informatics and Diabetes Education and Telemedicine (IDEATel) Project. Where items were comparable, service use was compared with that of a nationally representative group of Medicare beneficiaries with diabetes, using data from the Medical Expenditure Panel Survey. Compared to nationally representative groups, the underserved groups reported worse general health but similar health care service use, with the exception of home care. However, compared to the underserved rural group, the underserved, largely minority urban group, reported worse general health (P < 0.0001); more inpatient nights (P = 0.003), emergency room visits (P < 0.001), and home health care (P < 0.001); spent more time on self-care; and had more difficulty with housework, meal preparation, and personal care. Differences in service use between urban and rural groups within the underserved group substantially exceeded differences between the underserved and nationally representative groups. These findings address a gap in knowledge about older, ethnically diverse individuals with diabetes living in medically underserved areas. This profile of disparate service use and health care practices among urban minority and rural majority underserved adults with diabetes can assist in the planning of future interventions. (Population Health Management 2011;14:11–20)
Poorly controlled hypertension (HTN) remains one of the most significant public health problems in the United States, in terms of morbidity, mortality, and economic burden. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes (TLC) for blood pressure (BP) reduction, the effectiveness of these approaches in primary care practices remains untested, especially among African Americans, who share a disproportionately greater burden of HTN-related outcomes.
This randomized controlled trial tests the effectiveness of a practice-based comprehensive therapeutic lifestyle intervention, delivered through group-based counseling and motivational interviewing (MINT-TLC) versus Usual Care (UC) in 200 low-income, African Americans with uncontrolled hypertension. MINT-TLC is designed to help patients make appropriate lifestyle changes and develop skills to maintain these changes long-term. Patients in the MINT-TLC group attend 10 weekly group classes focused on healthy lifestyle changes (intensive phase); followed by 3 monthly individual motivational interviewing (MINT) sessions (maintenance phase). The intervention is delivered by trained research personnel with appropriate treatment fidelity procedures. Patients in the UC condition receive a single individual counseling session on healthy lifestyle changes and print versions of the intervention materials. The primary outcome is within-patient change in both systolic and diastolic BP from baseline to 6 months. In addition to BP control at 6 months, other secondary outcomes include changes in the following lifestyle behaviors from baseline to 6 months: a) physical activity, b) weight loss, c) number of daily servings of fruits and vegetables and d) 24-hour urinary sodium excretion.
This vanguard trial will provide information on how to refine MINT-TLC and integrate it into a standard treatment protocol for hypertensive African Americans as a result of the data obtained; thus maximizing the likelihood of its translation into clinical practice.
Hypertension; African American; Therapeutic Lifestyle Changes; Practice-based trial
To determine whether a diabetes case management telemedicine intervention reduced healthcare expenditures, as measured by Medicare claims, and to assess the costs of developing and implementing the telemedicine intervention.
We studied 1665 participants in the Informatics for Diabetes Education and Telemedicine (IDEATel), a randomized controlled trial comparing telemedicine case management of diabetes to usual care. Participants were aged 55 years or older, and resided in federally designated medically underserved areas of New York State.
We analyzed Medicare claims payments for each participant for up to 60 study months from date of randomization, until their death, or until December 31, 2006 (whichever happened first). We also analyzed study expenditures for the telemedicine intervention over six budget years (February 28, 2000– February 27, 2006).
Mean annual Medicare payments (SE) were similar in the usual care and telemedicine groups, $9040 ($386) and $9669 ($443) per participant, respectively (p>0.05). Sensitivity analyses, including stratification by censored status, adjustment by enrollment site, and semi-parametric weighting by probability of dropping-out, rendered similar results. Over six budget years 28 821 participant/months of telemedicine intervention were delivered, at an estimated cost of $622 per participant/month.
Telemedicine case management was not associated with a reduction in Medicare claims in this medically underserved population. The cost of implementing the telemedicine intervention was high, largely representing special purpose hardware and software costs required at the time. Lower implementation costs will need to be achieved using lower cost technology in order for telemedicine case management to be more widely used.
Diabetes; informatics; telemedicine
We sought to examine the relationship between functional outcome and process of care for patients with hip fracture.
Research Design and Participants
We undertook a prospective cohort study in 4 hospitals of 554 patients treated with surgery for hip fracture.
Information on patient characteristics and processes of hospital care collected from the medical record, interviews, and bedside observations. Follow-up information obtained at 6 months on function (using the Functional Independence Measure [FIM]), survival, and readmission.
Individual processes of care were generally not associated with adjusted outcomes. A scale of 9 processes related to mobilization was associated with improved adjusted locomotion (P = 0.006), self care (P = 0.022), and transferring (P = 0.007) at 2 months, but the benefits were smaller and not significant by 6 months. These processes were not associated with mortality. The predicted value for the FIM locomotion measure (range, 2–14) at 2 months was 5.9 (95% confidence interval 5.4–6.4) for patients at the 10th percentile of performance on these processes compared with 7.1 (95% confidence interval 6.6, 7.6) at the 90th percentile. Patients who experienced no hospital complications and no readmissions retained the benefits in locomotion at 6 months. Anticoagulation processes were associated with improved transferring at 2 months (P = 0.046) but anticoagulation and other processes of care were not otherwise associated with improved function.
Our findings indicate the need to attend to all steps in the care of patients with hip fracture. Additionally, functional outcomes were more sensitive markers of improved process of care, compared with 6-month mortality, in the case of hip fracture.
quality; process; function; hip fracture
The aims of this paper are to present findings related to differential item functioning (DIF) in the Patient Reported Outcome Measurement Information System (PROMIS) depression item bank, and to discuss potential threats to the validity of results from studies of DIF. The 32 depression items studied were modified from several widely used instruments. DIF analyses of gender, age and education were performed using a sample of 735 individuals recruited by a survey polling firm. DIF hypotheses were generated by asking content experts to indicate whether or not they expected DIF to be present, and the direction of the DIF with respect to the studied comparison groups. Primary analyses were conducted using the graded item response model (for polytomous, ordered response category data) with likelihood ratio tests of DIF, accompanied by magnitude measures. Sensitivity analyses were performed using other item response models and approaches to DIF detection. Despite some caveats, the items that are recommended for exclusion or for separate calibration were “I felt like crying” and “I had trouble enjoying things that I used to enjoy.” The item, “I felt I had no energy,” was also flagged as evidencing DIF, and recommended for additional review. On the one hand, false DIF detection (Type 1 error) was controlled to the extent possible by ensuring model fit and purification. On the other hand, power for DIF detection might have been compromised by several factors, including sparse data and small sample sizes. Nonetheless, practical and not just statistical significance should be considered. In this case the overall magnitude and impact of DIF was small for the groups studied, although impact was relatively large for some individuals.
patient reported outcomes measurement information system; item response theory; differential item functioning; depression
We present results of a feasibility test of a sequential treatment strategy using continuation phase cognitive-behavioral therapy (CBT) to prevent relapse in youths with major depressive disorder (MDD) who have responded to acute phase pharmacotherapy.
Forty-six youths (ages 11–18 years) who had responded to 12 weeks of treatment with fluoxetine were randomized to receive either 6 months of continued antidepressant medication management (MM) or antidepressant MM plus relapse prevention CBT (MM+CBT). Primary outcome was time to relapse, defined as a Childhood Depression Rating Scale-Revised score of 40 or higher and 2 weeks of symptom worsening or clinical deterioration warranting alteration of treatment to prevent full relapse.
Cox proportional hazards regression, adjusting for depression severity at randomization and for the hazard of relapsing by age across the trial, revealed that participants in the MM treatment group had a significantly greater risk for relapse than those in the MM+CBT treatment group (hazard ratio = 8.80; 95% confidence interval 1.01–76.89; χ2 = 3.86, p = .049) during 6 months of continuation treatment. In addition, patient satisfaction was significantly higher in the MM+CBT group. No differences were found between the two treatment groups on attrition rate, serious adverse events, and overall global functioning.
These preliminary results suggest that continuation phase CBT reduces the risk for relapse by eightfold compared with pharmacotherapy responders who received antidepressant medication alone during the 6-month continuation phase.
depression; CBT; relapse prevention; sequential treatment
In the present study, we assess maternal depressive symptoms at the beginning and end of treatment to investigate the possible reciprocal relationship of maternal illness with the child’s depressive illness and treatment.
We present data on 146 children and their mothers who were participating in a pediatric acute treatment study of fluoxetine. Patients were assessed with the Children’s Depression Rating Scale-Revised at baseline and at each treatment visit. Mothers completed the Quick Inventory of Depressive Symptomatology-Self Report at baseline and end of acute treatment.
Thirty percent of mothers had moderate to severe levels of depressive symptoms at the child’s baseline assessment. Overall, mothers reported improvement in maternal depressive symptoms at the end of their child’s acute treatment, although maternal depression was not specifically targeted for intervention. Furthermore, mother’s depressive symptoms appear to be associated with the child’s depression severity both at the beginning and end of treatment. Mothers with higher levels of depressive symptoms had children with higher levels of depression severity at baseline and over the course of treatment. However, maternal depressive symptoms at baseline had no association with the rate of improvement of child depression severity.
This study indicates a positive relationship between the depression severity of mothers and their children. These findings highlight potential areas of intervention in the acute treatment of childhood depression.
maternal depressive symptoms; pediatric depression; acute treatment of pediatric depression
The authors compared fluoxetine and placebo in continuation treatment to prevent relapse of major depressive disorder in children and adolescents.
After a detailed evaluation, children and adolescents 7–18 years of age with major depressive disorder were treated openly with fluoxetine. Those who had an adequate response after 12 weeks, as indicated by a Clinical Global Impression improvement score of 1 or 2 and a decrease of at least 50% in Children’s Depression Rating Scale—Revised score, were randomly assigned to receive fluoxetine or placebo for an additional 6 months. The primary outcome measures were relapse and time to relapse. Relapse was defined as either a score of 40 or higher on the Children’s Depression Rating Scale with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. Additional analyses were conducted with relapse defined only as a score of 40 or higher on the Children’s Depression Rating Scale.
Of 168 participants enrolled in acute fluoxetine treatment, 102 were randomly assigned to continuation treatment with fluoxetine (N=50) or placebo (N=52). Of these, 21 participants (42.0%) in the fluoxetine group relapsed, compared with 36 (69.2%) in the placebo group, a significant difference. Similarly, under the stricter definition of relapse, fewer participants in the fluoxetine group relapsed (N=11; 22.0%) than in the placebo group (N=25; 48.1%). Time to relapse was significantly shorter in the placebo group.
Continuation treatment with fluoxetine was superior to placebo in preventing relapse and in increasing time to relapse in children and adolescents with major depression.
Examination of the equivalence of measures involves several levels, including conceptual equivalence of meaning, as well as quantitative tests of differential item functioning (DIF). The purpose of this review is to examine DIF in patient-reported outcomes. Reviewed were measures of self-reported depression, quality of life (QoL) and general health. Most measures of depression contained large amounts of DIF, and the impact of DIF at the scale level was typically sizeable. The studies of QoL and health measures identified a moderate amount of DIF; however, many of these studies examined only one type of DIF (uniform). Relative to DIF analyses of depression measures, less analysis of the impact of DIF on QoL and health measures was performed, and the authors of these analyses generally did not recommend remedial action, with one notable exception. While these studies represent good beginning efforts to examine measurement equivalence in patient-reported outcome measures, more cross-validation work is required using other (often larger) samples of different ethnic and language groups, as well as other methods that permit more extensive analyses of the type of DIF, together with magnitude and impact.
Differential Item Functioning (DIF); measurement equivalence; patient-reported outcomes; quality of life; depression; general health
Telemedicine is a promising but largely unproven technology for providing case management services to patients with chronic conditions and lower access to care.
To examine the effectiveness of a telemedicine intervention to achieve clinical management goals in older, ethnically diverse, medically underserved patients with diabetes.
Design, Setting, and Patients
A randomized controlled trial was conducted, comparing telemedicine case management to usual care, with blinded outcome evaluation, in 1,665 Medicare recipients with diabetes, aged ≥ 55 years, residing in federally designated medically underserved areas of New York State.
Home telemedicine unit with nurse case management versus usual care.
Main Outcome Measures
The primary endpoints assessed over 5 years of follow-up were hemoglobin A1c (HgbA1c), low density lipoprotein (LDL) cholesterol, and blood pressure levels.
Intention-to-treat mixed models showed that telemedicine achieved net overall reductions over five years of follow-up in the primary endpoints (HgbA1c, p = 0.001; LDL, p < 0.001; systolic and diastolic blood pressure, p = 0.024; p < 0.001). Estimated differences (95% CI) in year 5 were 0.29 (0.12, 0.46)% for HgbA1c, 3.84 (−0.08, 7.77) mg/dL for LDL cholesterol, and 4.32 (1.93, 6.72) mm Hg for systolic and 2.64 (1.53, 3.74) mm Hg for diastolic blood pressure. There were 176 deaths in the intervention group and 169 in the usual care group (hazard ratio 1.01 [0.82, 1.24]).
Telemedicine case management resulted in net improvements in HgbA1c, LDL-cholesterol and blood pressure levels over 5 years in medically underserved Medicare beneficiaries. Mortality was not different between the groups, although power was limited.
http://clinicaltrials.gov Identifier: NCT00271739.
To more fully characterize the spectrum of RRA.
A focus group study of nursing home staff members and residents who could reliably self-report.
A large urban, not-for-profit long-term care facility in New York City
7 residents and 96 staff members from multiple clinical and non-clinical occupational groups.
16 focus groups were conducted. Content was analyzed with nVivo 7 software for qualitative data.
35 different types of physical, verbal and sexual RRA were described, with screaming and/or yelling being the most common. Calling out and making noise were the most frequent of 29 antecedents identified as instigating episodes of RRA. RRA was most frequent in dining and residents’ rooms, and in the afternoon, though it occurred regularly throughout the facility at all times. While no proven strategies exist to manage RRA, staff described 25 self-initiated techniques to address the issue.
RRA is a ubiquitous phenomenon in nursing home settings with important consequences for affected individuals and facilities. Further epidemiologic research is necessary to more fully describe the phenomenon and identify risk factors and preventative strategies.
nursing home; dementia-related behaviors; focus groups
To illustrate the application of the Differential Item and Test Functioning (DFIT) method using English and Spanish versions of the Mini-Mental State Examination (MMSE).
Study participants were 65 years of age or older and lived in North Manhattan, New York. Of the 1578 study participants who were administered the MMSE 665 completed it in Spanish.
The MMSE contains 20 items that measure the degree of cognitive impairment in the areas of orientation, attention and calculation, registration, recall and language, as well as the ability to follow verbal and written commands.
After assessing the dimensionality of the MMSE scale, item response theory person and item parameters were estimated separately for the English and Spanish sample using Samejima’s 2-parameter graded response model. Then the DFIT framework was used to assess differential item functioning (DIF) and differential test functioning (DTF).
Nine items were found to show DIF; these were items that ask the respondent to name the correct season, day of the month, city, state, and 2 nearby streets, recall 3 objects, repeat the phrase no ifs, no ands, no buts, follow the command, “close your eyes,” and the command, “take the paper in your right hand, fold the paper in half with both hands, and put the paper down in your lap.” At the scale level, however, the MMSE did not show differential functioning.
Respondents to the English and Spanish versions of the MMSE are comparable on the basis of scale scores. However, assessments based on individual MMSE items may be misleading.
Mini-Mental State Examination; item response theory; Spanish; DIF; DFIT