Effect of a Multicomponent Home-Based Physical Therapy Intervention on Ambulation After Hip Fracture in Older Adults: The CAP Randomized Clinical Trial.

Importance: Disability persists after hip fracture in older persons. Current rehabilitation may not be sufficient to restore ability to walk in the community. Objective: To compare a multicomponent home-based physical therapy intervention (training) with an active control on ability to walk in the community. Design, Setting, and Participants: Parallel, 2-group randomized clinical trial conducted at 3 US clinical centers (Arcadia University, University of Connecticut Health Center, and University of Maryland, Baltimore). Randomization began on September 16, 2013, and ended on June 20, 2017; follow-up ended on October 17, 2017. Patients aged 60 years and older were enrolled after nonpathologic, minimal trauma hip fracture, if they were living in the community and walking without human assistance before the fracture, were assessed within 26 weeks of hospitalization, and were not able to walk during daily activities at the time of enrollment. A total of 210 participants were randomized and reassessed 16 and 40 weeks later. Interventions: The training intervention (active treatment) (n = 105) included aerobic, strength, balance, and functional training. The active control group (n = 105) received transcutaneous electrical nerve stimulation and active range-of-motion exercises. Both groups received 2 to 3 home visits from a physical therapist weekly for 16 weeks; nutritional counseling; and daily vitamin D (2000 IU), calcium (600 mg), and multivitamins. Main Outcomes and Measures: The primary outcome (community ambulation) was defined as walking 300 m or more in 6 minutes at 16 weeks after randomization. The study was designed to test a 1-sided hypothesis of superiority of training compared with active control. Results: Among 210 randomized participants (mean age, 80.8 years; 161 women [76.7%]), 197 (93.8%) completed the trial (187 [89.0%] by completing the 6-minute walk test at 16 weeks and 10 [4.8%] by adjudication of the primary outcome). Among these, 22 of 96 training participants (22.9%) and 18 of 101 active control participants (17.8%) (difference, 5.1% [1-sided 97.5% CI, -∞ to 16.3%]; 1-sided P = .19) became community ambulators. Seventeen training participants (16.2%) and 15 control participants (14.3%) had 1 or more reportable adverse events during the intervention period. The most common reportable adverse events reported were falls (training: 6 [5.7%], control: 4 [3.8%]), femur/hip fracture (2 in each group), pneumonia (training: 2, control: 0), urinary tract infection (training: 2, control: 0), dehydration (training: 0, control: 2), and dyspnea (training: 0, control: 2). Conclusions and Relevance: Among older adults with a hip fracture, a multicomponent home-based physical therapy intervention compared with an active control that included transcutaneous electrical nerve stimulation and active range-of-motion exercises did not result in a statistically significant improvement in the ability to walk 300 m or more in 6 minutes after 16 weeks. Trial Registration: ClinicalTrials.gov Identifier: NCT01783704.

Dynamic Effects of Depressive Symptoms on Osteoarthritis Knee Pain.

OBJECTIVE: To estimate the dynamic causal effects of depressive symptoms on osteoarthritis (OA) knee pain. METHODS: Marginal structural models were used to examine dynamic associations between depressive symptoms and pain over 48 months among older adults (n = 2,287) with radiographic knee OA (Kellgren/Lawrence grade 2 or 3) in the Osteoarthritis Initiative. Depressive symptoms at each annual visit were assessed (threshold ≥16) using the Center for Epidemiologic Studies Depression Scale. OA knee pain was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, rescaled to range from 0 to 100. RESULTS: Depressive symptoms at each visit were generally not associated with greater OA knee pain at subsequent time points. Causal mean differences in WOMAC pain score comparing depressed to nondepressed patients ranged from 1.78 (95% confidence interval [95% CI] -0.73, 4.30) to 2.58 (95% CI 0.23, 4.93) within the first and fourth years, and the depressive symptoms by time interaction were not statistically significant (P = 0.94). However, there was a statistically significant dose-response relationship between the persistence of depressive symptoms and OA knee pain severity (P = 0.002). Causal mean differences in WOMAC pain score comparing depressed to nondepressed patients were 0.89 (95% CI -0.17, 1.96) for 1 visit with depressive symptoms, 2.35 (95% CI 0.64, 4.06) for 2 visits with depressive symptoms, and 3.57 (95% CI 0.43, 6.71) for 3 visits with depressive symptoms. CONCLUSION: The causal effect of depressive symptoms on OA knee pain does not change over time, but pain severity significantly increases with the persistence of depressed mood.

Immunologic response to antiretroviral therapy by age among treatment-naive patients in Sub-Saharan Africa.

OBJECTIVE: To estimate the association between age at antiretroviral therapy (ART) initiation and immunologic response over time by stratum of baseline CD4 cell counts. DESIGN: Retrospective cohort analysis of data pooled from four President's Emergency Plan for AIDS Relief funded countries in Sub-Saharan Africa. METHODS: General linear models were used to estimate the mean CD4 cell count by age group within groups defined by baseline CD4 cell count. Kaplan-Meier methods were used to estimate time to achieving a CD4 cell count of at least 500 cells/µl by age group and stratified by baseline CD4 cell count. RESULTS: A total of 126 672 previously treatment-naive patients provided 466 482 repeated CD4 cell count measurements over 4 years of ART. The median baseline CD4 cell count for all age groups was less than 200 cells/µl. Patients aged 30-39, 40-49, 50-59, and 60 and older at ART initiation had significantly lower mean CD4 cell counts in most strata and at most time points than those 20-29 years old. Compared with those 20-29, all older age groups had a significantly longer time to, and lower rate of, achieving a CD4 cell count of 500 cells. CONCLUSION: Age is associated with the magnitude of CD4 cell gain and the amount of time it takes to gain cells at different levels of baseline CD4 cell count. The delay in achieving a robust immune response could have significant implications for the risk of tuberculosis reactivation as well as comorbidities associated with age in the management of older HIV-infected patients.

Factors associated with high cardiovascular risk in a primarily African American, urban HIV-infected population.

OBJECTIVE: To determine factors associated with increased risk of developing cardiovascular disease in a high-risk patient population. DESIGN: Cross-sectional analysis of a retrospective cohort study. METHODS: One-hundred patients at an inner city HIV clinic in 2008 were reviewed. The atherosclerotic vascular disease risk score was calculated using the Pooled Cohort Equation. Chi-square test was performed to identify associations of potential risk factors with elevated atherosclerotic vascular disease risk. RESULTS: Eighty-one participants were included in the final analysis. In total, 95.1% were African American, and 38.3% were women. The median atherosclerotic vascular disease risk score was 8.8% and 8.1% in 2008 and 2012, respectively. The medical co-morbidities associated with increased atherosclerotic vascular disease risk were hepatitis C infection (X2 = 3.93; p value = 0.048), elevated triglycerides levels (X2 = 4.0; p value = 0.046), and low albumin (X2 = 4.65; p value = 0.031). There were a higher number of women with known atherosclerotic vascular disease despite lower median atherosclerotic vascular disease risk score compared to men. CONCLUSION: An elevated risk of developing cardiovascular disease persists in high-risk demographic groups of the HIV epidemic even in the current HIV era. There is an unexplained gender disparity and some non-traditional risk factors not accounted for in the Pooled Cohort Equation may be contributing to the excess cardiovascular disease risk observed among HIV-infected patients.

Warfarin usage among elderly atrial fibrillation patients with traumatic injury, an analysis of United States Medicare fee-for-service enrollees.

This study examined warfarin usage for elderly Medicare beneficiaries with atrial fibrillation (AF) who suffered traumatic brain injury (TBI), hip fracture, or torso injuries. Using the 5% Chronic Condition Data Warehouse administrative claims data, this study included fee-for-service Medicare beneficiaries who had a single injury hospitalization (TBI, hip fracture, or major torso injury) between 1/1/2007 and 12/31/2009, with complete Medicare Parts A, B (no Medicare Advantage), and D coverage 6 months before injury, and who were aged 66 years or older and diagnosed with AF at least 1 year before injury. About 45% of the AF patients were using warfarin before TBI or torso injury, and 35% before hip fracture. After injury, there was a dramatic and persistent decrease in warfarin use in TBI and torso injury groups (30% for TBI and 37% for torso injury at 12 months after injury). Warfarin usage in hip fracture patients also dropped after injury but returned to pre-injury level within 4 months. TBI and torso injury lead to significant decreases in warfarin usage in elderly AF patients. Further research is needed to understand reasons for the pattern and to develop evidence-based management strategies in the post-acute setting.

Stroke incidence following traumatic brain injury in older adults.

OBJECTIVE: Following traumatic brain injury (TBI), older adults are at an increased risk of hemorrhagic and thromboembolic events, but it is unclear whether the increased risk continues after hospital discharge. We estimated incidence rates of hemorrhagic and ischemic stroke following hospital discharge for TBI among adults 65 years or older and compared them with pre-TBI rates. PARTICIPANTS: A total of 16 936 Medicare beneficiaries 65 years or older with a diagnosis of TBI in any position on an inpatient claim between June 1, 2006, and December 31, 2009, who survived to hospital discharge. DESIGN: Retrospective analysis of a random 5% sample of Medicare claims data. MAIN MEASURES: Hemorrhagic stroke was defined as ICD-9 (International Classification of Diseases, Ninth Revision) codes 430.xx-432.xx. Ischemic stroke was defined as ICD-9 codes 433.xx-435.xx, 437.0x, and 437.1x. RESULTS: There was a 6-fold increase in the rate of hemorrhagic stroke following TBI compared with the pre-TBI period (adjusted rate ratio, 6.5; 95% confidence interval, 5.3-7.8), controlling for age and sex. A smaller increase in the rate of ischemic stroke was observed (adjusted rate ratio, 1.3; 95% CI, 1.2-1.4). CONCLUSION: Future studies should investigate causes of increased stroke risk post-TBI as well as effective treatment options to reduce stroke risk and improve outcomes post-TBI among older adults.

Benefits and risks of anticoagulation resumption following traumatic brain injury.

IMPORTANCE: The increased risk of hemorrhage associated with anticoagulant therapy following traumatic brain injury creates a serious dilemma for medical management of older patients: Should anticoagulant therapy be resumed after traumatic brain injury, and if so, when? OBJECTIVE: To estimate the risk of thrombotic and hemorrhagic events associated with warfarin therapy resumption following traumatic brain injury. DESIGN, SETTING, AND PARTICIPANTS: Retrospective analysis of administrative claims data for Medicare beneficiaries aged at least 65 years hospitalized for traumatic brain injury during 2006 through 2009 who received warfarin in the month prior to injury (n = 10,782). INTERVENTION: Warfarin use in each 30-day period following discharge after hospitalization for traumatic brain injury. MAIN OUTCOMES AND MEASURES: The primary outcomes were hemorrhagic and thrombotic events following discharge after hospitalization for traumatic brain injury. Hemorrhagic events were defined on inpatient claims using International Classification of Diseases, Ninth Revision, Clinical Modification codes and included hemorrhagic stroke, upper gastrointestinal bleeding, adrenal hemorrhage, and other hemorrhage. Thrombotic events included ischemic stroke, pulmonary embolism, deep venous thrombosis, and myocardial infarction. A composite of hemorrhagic or ischemic stroke was a secondary outcome. RESULTS: Medicare beneficiaries with traumatic brain injury were predominantly female (64%) and white (92%), with a mean (SD) age of 81.3 (7.3) years, and 82% had atrial fibrillation. Over the 12 months following hospital discharge, 55% received warfarin during 1 or more 30-day periods. We examined the lagged effect of warfarin use on outcomes in the following period. Warfarin use in the prior period was associated with decreased risk of thrombotic events (relative risk [RR], 0.77 [95% CI, 0.67-0.88]) and increased risk of hemorrhagic events (RR, 1.51 [95% CI, 1.29-1.78]). Warfarin use in the prior period was associated with decreased risk of hemorrhagic or ischemic stroke (RR, 0.83 [95% CI, 0.72-0.96]). CONCLUSIONS AND RELEVANCE: Results from this study suggest that despite increased risk of hemorrhage, there is a net benefit for most patients receiving anticoagulation therapy, in terms of a reduction in risk of stroke, from warfarin therapy resumption following discharge after hospitalization for traumatic brain injury.

Care-related risk factors for hospital-acquired pressure ulcers in elderly adults with hip fracture.

OBJECTIVES: To identify care-related factors associated with hospital-acquired pressure ulcers (HAPUs). DESIGN: Prospective cohort study. SETTING: Nine hospitals in Baltimore Hip Studies network. PARTICIPANTS: Six hundred fifty-eight individuals aged 65 and older who underwent surgery for hip fracture. MEASUREMENTS: Skin examinations at baseline and on alternating days until hospital discharge. Participants were deemed to have a HAPU if they developed one or more new Stage 2 or higher pressure ulcers (PUs) during the hospital stay. RESULTS: Longer emergency department stays were associated with lower HAPU incidence (>4-6 hours: adjusted incidence rate ratio (aIRR) = 0.68, 95% confidence interval (CI) = 0.48-0.96; >6 hours: aIRR = 0.68, 95% CI = 0.46-0.99, both vs ≤ 4 hours). Participants with 24 hours or longer between admission and surgery had a higher postsurgery HAPU rate than those with less than 24 hours (aIRR = 1.62, 95% CI = 1.24-2.11). Surgery with general anesthesia had a lower postsurgery HAPU rate than surgery with other types of anesthesia (aIRR = 0.66, 95% CI = 0.49-0.88). There was no significant association between HAPU incidence and timing of transport to the hospital, type of transport to the hospital, or surgery duration. CONCLUSION: Most of the factors hypothesized to be associated with higher PU incidence were associated with lower incidence or were not significantly associated, suggesting that HAPU development may not be as sensitive to care-related factors as commonly believed. Rigorous studies of innovative preventive interventions are needed to inform policy and practice.

Screening questionnaires for parkinsonism: a systematic review.

Parkinson's disease (PD) is a common, treatable movement disorder that often remains undiagnosed despite clinically manifest symptoms. Screening for parkinsonism could lead to improved detection and earlier treatment, and facilitate research studies of PD prevalence. In order to determine the feasibility of screening, this study evaluated the validity of previously developed screening questionnaires. We systematically searched online databases PubMed and EMBASE for English-language studies published between 1980 and 2009. In each database a "Parkinson(s) disease" or "parkinsonism" term was combined with a screening term ("screening instrument," "screening questionnaire," "screen" or "prevalence survey") and a validity term ("validation," "sensitivity" and "specificity"). Included studies reported the psychometric properties of at least one self-report questionnaire for parkinsonism. Twenty-seven studies met the inclusion criteria. From these studies, 9 screening questionnaires were identified. Sensitivity and specificity estimates varied widely. Sensitivity estimates were as high as 100% when questionnaires were tested among previously diagnosed PD patients and included a high number of parkinsonism specific items, but were as low as 48% when tested among early cases in a community-based sample. Specificity estimates were lower, ranging from 22 to 100%. An older sample, presence of multiple co-morbid conditions and lower literacy led to lower specificity estimates. Higher specificity estimates were seen when the screening questionnaires were administered by a physician. Screening questionnaires can detect symptomatic parkinsonism. However, the performance of these questionnaires varied based on the individual items, study sample, and method of administration. The performance of screening questionnaires in the detection of early or mild parkinsonism was modest.

Pressure-redistributing support surface use and pressure ulcer incidence in elderly hip fracture patients.

OBJECTIVES: To evaluate the association between pressure-redistributing support surface (PRSS) use and incident pressure ulcers in older adults with hip fracture. DESIGN: Secondary analysis of data from prospective cohort with assessments performed as soon as possible after hospital admission and on alternating days for 21 days. SETTING: Nine hospitals in the Baltimore Hip Studies network and 105 postacute facilities to which participants were discharged. PARTICIPANTS: Six hundred fifty-eight people aged 65 and older who underwent surgery for hip fracture. MEASUREMENTS: Full-body examination for pressure ulcers; bedbound status; and PRSS use, recorded as none, powered (alternating pressure mattresses, low-air-loss mattresses, and alternating pressure overlays), or nonpowered (high-density foam, static air, or gel-filled mattresses or pressure-redistributing overlays except for alternating pressure overlays). RESULTS: Incident pressure ulcers (IPUs), Stage 2 or higher, were observed at 4.2% (195/4,638) of visits after no PRSS use, 4.5% (28/623) of visits after powered PRSS use, and 3.6% (54/1,496) of visits after nonpowered PRSS use. The rate of IPU per person-day of follow-up did not differ significantly between participants using powered PRSSs and those not using PRSSs. The rate also did not differ significantly between participants using nonpowered PRSSs and those not using PRSSs, except in the subset of bedbound participants (incidence rate ratio=0.3, 95% confidence interval=0.1-0.7). CONCLUSION: PRSS use was not associated with a lower IPU rate. Clinical guidelines may need revision for the limited effect of PRSS use, and it may be appropriate to target PRSS use to bedbound patients at risk of pressure ulcers.

Frequent manual repositioning and incidence of pressure ulcers among bed-bound elderly hip fracture patients.

Frequent manual repositioning is an established part of pressure ulcer prevention, but there is little evidence for its effectiveness. This study examined the association between repositioning and pressure ulcer incidence among bed-bound elderly hip fracture patients, using data from a 2004-2007 cohort study in nine Maryland and Pennsylvania hospitals. Eligible patients (n=269) were age ≥ 65 years, underwent hip fracture surgery, and were bed-bound at index study visits (during the first 5 days of hospitalization). Information about repositioning on the days of index visits was collected from patient charts; study nurses assessed presence of stage 2+ pressure ulcers 2 days later. The association between frequent manual repositioning and pressure ulcer incidence was estimated, adjusting for pressure ulcer risk factors using generalized estimating equations and weighted estimating equations. Patients were frequently repositioned (at least every 2 hours) on only 53% (187/354) of index visit days. New pressure ulcers developed at 12% of visits following frequent repositioning vs. 10% following less frequent repositioning; the incidence rate of pressure ulcers per person-day did not differ between the two groups (incidence rate ratio 1.1, 95% confidence interval 0.5-2.4). No association was found between frequent repositioning of bed-bound patients and lower pressure ulcer incidence, calling into question the allocation of resources for repositioning.

Use of pressure-redistributing support surfaces among elderly hip fracture patients across the continuum of care: adherence to pressure ulcer prevention guidelines.

PURPOSE: To estimate the frequency of use of pressure-redistributing support surfaces (PRSS) among hip fracture patients and to determine whether higher pressure ulcer risk is associated with greater PRSS use. DESIGN AND METHODS: Patients (n = 658) aged >or=65 years who had surgery for hip fracture were examined by research nurses at baseline and on alternating days for 21 days. Information on PRSS use and pressure ulcer risk factors was recorded at each assessment visit. Other information was obtained by interview and chart review. RESULTS: A PRSS was observed at 36.4% of the 5,940 study visits. The odds of PRSS use were lower in the rehabilitation setting (adjusted odds ratio [OR] 0.4, 95% confidence interval [CI] 0.3-0.6), in the nursing home (adjusted OR 0.2, 95% CI 0.1-0.3), and during readmission to the acute setting (adjusted OR 0.6, 95% CI 0.4-0.9) than in the initial acute setting. There was wide variation in frequency of PRSS use by admission hospital, even after adjusting for pressure ulcer risk factors. The relationships between PRSS use and pressure ulcer risk factors were not strong. IMPLICATIONS: In this study of hip fracture patients, adherence to guidelines for PRSS use was low and was based more on facility-related factors than on patient risk. There is an urgent need for health care providers to improve strategies for the prevention of pressure ulcers in high-risk patients.

Chronic inflammatory demyelinating polyneuropathy disease activity status: recommendations for clinical research standards and use in clinical practice.

Defining long-term outcomes in chronic inflammatory demyelinating polyneuropathy (CIDP) has been complicated by varying definitions of treatment response and differing scales measuring impairment or disability. An expert panel was convened to devise a CIDP Disease Activity Status (CDAS) and to classify long-term outcome by applying it to 106 patients with a consensus diagnosis of CIDP. Sixty of these cases were graded blindly by three independent reviewers to assess inter-rater reliability. The mean duration of follow-up was 6.4 years (range, 3 months-23 years). Eleven percent of patients were classified as cured (stable examination and off treatment for ≥5 years), 20% were in remission (stable and off treatment for <5 years), 44% had stable active disease but required ongoing therapy for at least 1 year, 7% were improving after recent initiation of therapy, and 18% had unstable active disease (treatment naïve or treatment refractory). Excellent inter-rater reliability was observed (kappa scores: 0.93-0.97; p < 0.0001). The CDAS is considered a simple and reproducible tool to classify patients with CIDP according to disease activity and treatment status that can be applied easily in practice and potentially to select patients for clinical trials.

Pressure ulcers in elderly patients with hip fracture across the continuum of care.

OBJECTIVES: To identify care settings associated with greater pressure ulcer risk in elderly patients with hip fracture in the postfracture period. DESIGN: Prospective cohort study. SETTING: Nine hospitals that participate in the Baltimore Hip Studies network and 105 postacute facilities to which patients from these hospitals were discharged. PARTICIPANTS: Hip fracture patients aged 65 and older who underwent surgery for hip fracture. MEASUREMENTS: A full-body skin examination was conducted at baseline (as soon as possible after hospital admission) and repeated on alternating days for 21 days. Patients were deemed to have an acquired pressure ulcer (APU) if they developed one or more new stage 2 or higher pressure ulcers after hospital admission. RESULTS: In 658 study participants, the APU cumulative incidence at 32 days after initial hospital admission was 36.1% (standard error 2.5%). The adjusted APU incidence rate was highest during the initial acute hospital stay (relative risk (RR)=2.2, 95% confidence interval (CI)=1.3-3.7) and during re-admission to the acute hospital (RR=2.2, 95% CI=1.1-4.2). The relative risks in rehabilitation and nursing home settings were 1.4 (95% CI=0.8-2.3) and 1.3 (95% CI=0.8-2.1), respectively. CONCLUSION: Approximately one-third of hip fracture patients developed an APU during the study period. The rate was highest in the acute setting, a finding that is significant in light of Medicare's policy of not reimbursing hospitals for the treatment of hospital-APUs. Hip fracture patients constitute an important group to target for pressure ulcer prevention in hospitals.

Pressure ulcer preventive device use among elderly patients early in the hospital stay.

BACKGROUND: Clinical guidelines for the prevention of pressure ulcers advise that pressure-reducing devices should be used for all patients at risk of or with pressure ulcers and that all pressure ulcers should be documented in the patient record. Adherence to these guidelines among elderly hospital patients early in the hospital stay has not been examined in prior studies. OBJECTIVE: The objective of this study was to examine adherence to guidelines by determining the frequency and correlates of use of preventive devices early in the hospital stay of elderly patients and by determining the frequency and correlates of recording pressure ulcers in the patient record. METHODS: This was a cross-sectional study of 792 patients aged 65 years or older admitted through the emergency department to the inpatient medical service at two teaching hospitals in Philadelphia, Pennsylvania, between 1998 and 2001. Patients were examined by a research nurse on Hospital Day 3 (median of 48 hours after admission) to determine the use of preventive devices, presence of pressure ulcers, and risk of pressure ulcers (by Norton scale). Data on additional risk factors were obtained from the admission nursing assessment in the patient record. Data on documentation of pressure ulcers were obtained by chart abstraction. RESULTS: Only 15% of patients had any preventive devices in use at the time of the examination. Among patients considered at risk of pressure ulcers (Norton score < or =14), only 51% had a preventive device. In multivariable analyses, high risk of pressure ulcers was associated with use of preventive devices (odds ratio = 41.8, 95% confidence interval = 14.0-124.6), whereas the type and stage of pressure ulcer were not. Documentation of a pressure ulcer was present for only 68% of patients who had a pressure ulcer according to the research examination. DISCUSSION: Use of preventive devices and documentation of pressure ulcers are suboptimal even among patients at high risk.

Validity of pressure ulcer diagnosis using digital photography.

The purpose of this study was to evaluate the validity of digital photographs for the assessment of the presence of pressure ulcers stage 2 or higher. Participants were 48 patients (28 white and 20 black) with pressure ulcers identified in the course of a wound specialist's routine clinical practice at the University of Maryland Medical Center. One pressure ulcer and one unaffected skin area were photographed on each participating patient. The gold standard diagnosis (stage 2 pressure ulcer vs. stage 1 or no pressure ulcer) was recorded by the wound specialist based on bedside examination. The photographs were reviewed blindly by another wound expert. The sensitivity of the blinded assessment was 97% (95% confidence interval [CI] 91-100%). The specificity was 97% (95% CI 92-100%). The sensitivity and specificity were both 100% in the white patients. In black patients, the sensitivity and specificity were 92% (95% CI 75-100%) and 93% (95% CI 82-100%), respectively. These results suggest that the use of photographic images to assess the presence or absence of a pressure ulcer stage 2 or higher has a high degree of validity. Since blinded outcome assessment is one of the cornerstones of good clinical trial design, photography offers the potential to strengthen future studies.

Minority enrollment in Parkinson's disease clinical trials.

Under-representation of minorities in clinical trials limits access to information relevant to all segments of the population. We assessed the enrollment of minority subjects with Parkinson's disease (PD) into clinical trials. We searched PubMed for published studies of PD trials conducted in the US over the past 20 years and found that only 41 reported racial/ethnic participation (17%). In those trials reporting race/ethnicity, 8% of subjects were non-white, compared to 20% of the non-white US population over age 60. Results of this study identified the need for better reporting of racial composition in clinical trials and for the enrollment of more minority participants in research studies.

Lung cancer risk following detection of pulmonary scarring by chest radiography in the prostate, lung, colorectal, and ovarian cancer screening trial.

BACKGROUND: Fibrotic scars are frequently found in proximity to lung cancer at the time of cancer diagnosis. However, the nature of the relationship between pulmonary scarring and lung cancer remains uncertain. Our objective was to test whether localized pulmonary scarring is associated with increased lung cancer risk. METHODS: Cohort analysis of data from the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. We included 66 863 cancer-free trial participants aged 55 to 74 years, who received a baseline chest radiographic examination and were followed up subsequently for up to 12 years. We used proportional hazards models to estimate hazard ratios (HRs) for lung cancer associated with scarring, adjusting for age, sex, race, and cigarette smoking, and in relation to laterality of scarring. The main outcome measure was incident lung cancer. RESULTS: Scarring was present on the baseline chest radiograph for 5041 subjects (7.5%). Scarring was associated with elevated lung cancer risk (809 lung cancer cases [HR, 1.5; 95% confidence interval {CI}, 1.2-1.8]). This association was specific for cancer in the lung ipsilateral to the scar (HR, 1.8; 95% CI, 1.4-2.4) and absent for contralateral cancer (HR, 0.9; 95% CI, 0.7-1.2). Ipsilateral lung cancer risk was elevated throughout the follow-up period (interval-specific HRs, 1.6, 2.0, 2.1, and 1.7 during 0.01-2.00, 2.01-4.00, 4.01-6.00, and 6.01-12.00 years after baseline chest radiography, respectively). CONCLUSIONS: The relationship between pulmonary scarring and lung cancer was specific to the same lung and extended over time. These findings are consistent with the hypothesis that localized inflammatory processes associated with scarring promote the subsequent development of lung cancer.

Prevalence of pressure ulcers on hospital admission among nursing home residents transferred to the hospital.

The purpose of this study was to compare the prevalence of pressure ulcers among newly hospitalized nursing home residents and among newly hospitalized patients from nonnursing home settings. Study participants were at least 65 years old and admitted through the emergency department to one of two study hospitals. Research nurses ascertained the presence of pressure ulcers (stage 1-4) by visual skin assessment on the third day following admission to the hospital unit. Other data were collected by clinical examination, interview, and medical record review. The prevalence of preexisting pressure ulcers at the time of admission was 26.2% among those admitted from a nursing home and 4.8% among those admitted from another living situation (odds ratio 5.5, 95% confidence interval 4.3-7.1). After adjustment for confounders, the association between admission from a nursing home and pressure ulcer prevalence on admission was reduced (odds ratio 1.51, 95% confidence interval 1.03-2.23). These results indicate that admission from a nursing home is a potent marker for pressure ulcer risk and that the excess risk is largely mediated by the higher prevalence of pressure ulcer risk factors among patients admitted from a nursing home. The results highlight the importance of continuity of care across transitions between care settings.