Comparing Self-Management Programs with and without Peer Support among Patients with Chronic Obstructive Pulmonary Disease: A Clinical Trial.

Rationale: Self-management support (SMS) is an essential component of care for patients who have chronic obstructive pulmonary disease (COPD), but there is little evidence on how to provide SMS most effectively to these patients. Peer support (i.e., support provided by a person with a similar medical condition) has been successfully used to promote self-management among patients with various chronic conditions, yet no randomized studies have focused on testing its effects for patients with COPD. Objectives: To assess whether adding peer support to healthcare professional (HCP) support to help patients with COPD self-management results in better health-related quality of life (HRQoL) and less acute care use. Methods: A two-arm randomized controlled trial was performed at one academic and one community hospital and their affiliate clinics. The study population included patients aged ⩾40 years who had been diagnosed with COPD by a physician and were currently receiving daily treatment for it. Two self-management support strategies were compared over 6 months. One strategy relied on the HCP for COPD self-management (HCP support); the other used a dual approach involving both HCPs and peer supporters (HCP Plus Peer). The primary outcome was change in HRQoL measured by the St. George's Respiratory Questionnaire at 6 months (range, 0-100, lower is better; four-point meaningful difference). Secondary outcomes included COPD-related and all-cause hospitalizations and emergency department visits. Analysis was conducted under intention to treat. Results: The number of enrolled participants was 292. Mean age was 67.7 (standard deviation, 9.4) years; 70.9% of participants were White, and 61.3% were female. St. George's Respiratory Questionnaire scores were not significantly different between the study arms at 6 months. HCP Plus Peer arm participants had fewer COPD-related acute care events at 3 months (incidence rate ratio, 0.68; 95% confidence interval [CI], 0.50-0.93) and 6 months (incidence rate ratio, 0.84; 95% CI, 0.71-0.99). Conclusions: Adding peer support to HCP support to help patients self-manage COPD did not further improve HRQoL in this study. However, it did result in fewer COPD-related acute care events during the 6-month intervention period. Clinical trial registered with www.clinicaltrials.gov (NCT02891200).

Perspective on reducing errors in research.

Efforts to ensure research integrity has mostly focused on research misconduct. However, the complexity of research operations and processes makes research work also prone to unintentional errors. To safeguard against errors and their consequences, strategies for error reduction, detection, and mitigation can be applied to research work. Nurturing a scientific culture that encourages error disclosure and rectification is essential to reduce the negative consequences of errors. Creating repositories where errors can be reported can enable learning from errors and creation of more robust research processes.

Methodology and baseline characteristics of a randomized controlled trial testing a health care professional and peer-support program for patients with chronic obstructive pulmonary disease: The BREATHE2 study.

BACKGROUND: Self-management support (SMS) for patients with COPD can improve health-related quality of life (HRQOL). However, it remains unclear what SMS strategies are most effective. Using peer support to advance self-management is promising, as peer supporters possess credibility and can serve as role models. METHODS: We conducted a single-blinded RCT comparing the effectiveness of two strategies to support patients with COPD. The strategies were 'Health Care Professional (HCP)' and 'HCP Plus Peer' support. Peer support was provided by patients with COPD who have stopped smoking, completed an acute pulmonary rehabilitation program, and met the requirements for becoming a peer supporter. We enrolled patients receiving treatment at inpatient and outpatient settings. Patients were encouraged to invite one family-caregiver to enroll with them. The primary outcome measure was the change in HRQOL at 6 months post enrollment. Secondary outcomes included COPD-related and all-cause hospitalizations and ED visits. Caregiver outcomes included preparedness for caregiving, caregiver stress, and coping. RESULTS: A total of 292 patients as well as 50 family-caregivers were enrolled. The average patient age was 67.3 yrs. (SD 9.4), 61% were female and 26% were African-Americans. The majority of caregivers were females (68%) and were a spouse/partner (58%). DISCUSSION: This study tested a dual strategy for providing support to patients with COPD that incorporates peer and health care professional support. The study had minimal exclusion criteria. If shown effective, the study offers a program of peer support that can be readily implemented in health care settings.

Effect of a Hospital-Initiated Program Combining Transitional Care and Long-term Self-management Support on Outcomes of Patients Hospitalized With Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial.

Importance: Patients hospitalized for chronic obstructive pulmonary disease (COPD) exacerbations have high rehospitalization rates and reduced quality of life. Objective: To evaluate whether a hospital-initiated program that combined transition and long-term self-management support for patients hospitalized due to COPD and their family caregivers can improve outcomes. Design, Setting, and Participants: Single-site randomized clinical trial conducted in Baltimore, Maryland, with 240 participants. Participants were patients hospitalized due to COPD, randomized to intervention or usual care, and followed up for 6 months after hospital discharge. Enrollment occurred from March 2015 to May 2016; follow-up ended in December 2016. Interventions: The intervention (n = 120) involved a comprehensive 3-month program to help patients and their family caregivers with long-term self-management of COPD. It was delivered by nurses with special training on supporting patients with COPD using standardized tools. Usual care (n = 120) included transition support for 30 days after discharge to ensure adherence to discharge plan and connection to outpatient care. Main Outcomes and Measures: The primary outcome was number of COPD-related acute care events (hospitalizations and emergency department visits) per participant at 6 months. The co-primary outcome was change in participants' health-related quality of life measured by the St George's Respiratory Questionnaire (SGRQ) at 6 months after discharge (score, 0 [best] to 100 [worst]; 4-point difference is clinically meaningful). Results: Among 240 patients who were randomized (mean [SD] age, 64.9 [9.8] years; 61.7% women), 203 (85%) completed the study. The mean (SD) baseline SGRQ score was 62.3 (18.8) in the intervention group and 63.6 (17.4) in the usual care group. The mean number of COPD-related acute care events per participant at 6 months was 1.40 (95% CI, 1.01-1.79) in the intervention group vs 0.72 (95% CI, 0.45-0.97) in the usual care group (difference, 0.68 [95% CI, 0.22-1.15]; P = .004). The mean change in participants' SGRQ total score at 6 months was 2.81 in the intervention group and -2.69 in the usual care group (adjusted difference, 5.18 [95% CI, -2.15 to 12.51]; P = .11). During the study period, there were 15 deaths (intervention: 8; usual care: 7) and 339 hospitalizations (intervention: 202; usual care: 137). Conclusions and Relevance: In a single-site randomized clinical trial of patients hospitalized due to COPD, a 3-month program that combined transition and long-term self-management support resulted in significantly greater COPD-related hospitalizations and emergency department visits, without improvement in quality of life. Further research is needed to determine reasons for this unanticipated finding. Trial Registration: ClinicalTrials.gov Identifier: NCT02036294.

Effect of a Program Combining Transitional Care and Long-term Self-management Support on Outcomes of Hospitalized Patients With Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial.

Importance: Patients hospitalized for chronic obstructive pulmonary disease (COPD) exacerbations have high rehospitalization rates and reduced quality of life. Objective: To evaluate a hospital-initiated program that combined transition and long-term self-management support for patients hospitalized due to COPD and their family caregivers. Design, Setting, and Participants: This single-site randomized clinical trial was conducted in Baltimore, Maryland, with 240 participants. Participants were patients hospitalized due to COPD, randomized to intervention or usual care, and followed up for 6 months after hospital discharge. Enrollment occurred from March 2015 to May 2016; follow-up ended in December 2016. Interventions: The intervention (n = 120) was a comprehensive 3-month program to help patients and their family caregivers with long-term self-management of COPD. It was delivered by COPD nurses (nurses with special training on supporting patients with COPD using standardized tools). Usual care (n = 120) included transition support for 30 days after discharge to ensure adherence to discharge plan and connection to outpatient care. Main Outcomes and Measures: The primary outcome was number of COPD-related acute care events (hospitalizations and emergency department visits) per participant at 6 months. The co-primary outcome was change in participants' health-related quality of life measured by the St George's Respiratory Questionnaire (SGRQ) at 6 months after discharge (score, 0 [best] to 100 [worst]; 4-point difference is clinically meaningful). Results: Among 240 patients who were randomized (mean [SD] age, 64.9 [9.8] years; females, 61.7%), 203 (85%) completed the study. The mean (SD) baseline SGRQ score was 63.1 (19.9) in the intervention group and 62.6 (19.3) in the usual care group. The mean number of COPD-related acute care events per participant at 6 months was 0.72 (95% CI, 0.45-0.97) in the intervention group vs 1.40 (95% CI, 1.01-1.79) in the usual care group (difference, 0.68 [95% CI, 0.22 to 1.15]; P = .004). The mean change in participants' SGRQ total score at 6 months was -1.53 in the intervention and +5.44 in the usual care group (adjusted difference, -6.69 [95% CI, -12.97 to -0.40]; P = .04). During the study period, there were 15 deaths (intervention: 7; usual care: 8) and 337 hospitalizations (intervention: 135; usual care: 202). Conclusions and Relevance: In a single-site randomized clinical trial of patients hospitalized due to COPD, a 3-month program that combined transition and long-term self-management support resulted in significantly fewer COPD-related hospitalizations and emergency department visits and better health-related quality of life at 6 months after discharge. Further research is needed to evaluate this intervention in other settings. Trial Registration: ClinicalTrials.gov Identifier: NCT02036294.

The Prevalence and Specificity of Depression Diagnosis in a Clinic-Based Population of Adults With Type 2 Diabetes Mellitus.

OBJECTIVE: To estimate the crude prevalence of minor depressive disorder (MinD) in a clinic-based population of adults with type 2 diabetes. METHODS: We screened a clinical sample of 702 adults with type 2 diabetes for depressive symptoms using the Patient Health Questionnaire-2 and performed a structured diagnostic psychiatric interview on 52 screen-positive and a convenience sample of 51 screen-negative individuals. Depressive disorder diagnoses were made using Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) Text Revised criteria and categorized as MinD, major depressive disorder (MDD), or no depressive disorder. We estimated prevalence of MinD and MDD and derived 95% CIs. RESULTS: The crude prevalence of current, past, and current or past MinD was 4.3% (95% CI: 0.9-9.2%), 9.6% (95% CI: 3.9-15.9%), and 13.9% (95% CI: 7.7-21.2%), respectively. The crude prevalence of current, past, and current or past MDD was slightly higher-5.0% (95% CI: 1.9-9.4%), 12.0% (95% CI: 6.1-19.5%), and 17.0% (95% CI: 10.1-24.8%), respectively. There was a high prevalence of coexisting anxiety disorders in individuals with MinD (42.2%) and MDD (8.1%). Hemoglobin A1c levels were not significantly different in individuals with MinD or MDD compared to those without a depressive disorder. CONCLUSIONS: MinD is comparably prevalent to MDD in patients with type 2 diabetes; both disorders are associated with concomitant anxiety disorders. MinD is not included in the DSM-5; however, our data support continuing to examine patients with chronic medical conditions for MinD.

Neuroimaging evidence of white matter inflammation in newly diagnosed systemic lupus erythematosus.

OBJECTIVE: Central nervous system (CNS) involvement occurs frequently in systemic lupus erythematosus (SLE) and frequently results in morbidity. The primary pathophysiology of CNS involvement in SLE is thought to be inflammation secondary to autoantibody-mediated vasculitis. Neuroimaging studies have shown hypometabolism (representing impending cell failure) and atrophy (representing late-stage pathology), but not inflammation. The purpose of this study was to detect the presence and regional distribution of inflammation (hypermetabolism) and tissue failure, apoptosis, or atrophy (hypometabolism). METHODS: Eighty-five patients with newly diagnosed SLE, who had no focal neurologic symptoms, were studied. Disease activity was quantified using the Safety of Estrogens in Lupus Erythematosus: National Assessment version of the SLE Disease Activity Index (SELENA-SLEDAI), a validated index of SLE-related disease activity. 18Fluorodeoxyglucose (FDG) positron emission tomography (PET) images of glucose uptake were analyzed by visual inspection and as group statistical parametric images, using the SELENA-SLEDAI score as the analysis regressor. RESULTS: SELENA-SLEDAI-correlated increases in glucose uptake were found throughout the white matter, most markedly in heavily myelinated tracts. SELENA-SLEDAI-correlated decreases were found in the frontal and parietal cortex, in a pattern similar to that seen during visual inspection and presented in previous reports of hypometabolism. CONCLUSION: The SELENA-SLEDAI-correlated increases in glucose consumption are potential evidence of inflammation, consistent with prior reports of hypermetabolism in inflammatory disorders. To our knowledge, this is the first imaging-based evidence of SLE-induced CNS inflammation in an SLE inception cohort. The dissociation among 18FDG uptake characteristics, spatial distribution, and disease activity correlation is in accordance with the notion that glucose hypermetabolism and hypometabolism reflect fundamentally different aspects of the pathophysiology of SLE with CNS involvement.

Memantine in systemic lupus erythematosus: a randomized, double-blind placebo-controlled trial.

OBJECTIVES: Cognitive impairment affects up to 80% of systemic lupus erythematosus (SLE) patients within 10 years of diagnosis. Memantine, a seronergic receptor and nicotine acetylcholine receptor antagonist, acts on the glutamatergic system through the NMDA receptor and is used to treat dementia. We investigated whether it had benefit for SLE cognitive impairment. METHODS: A randomized double-blind, placebo-controlled single-center 12-week trial of memantine titrated to 20 mg/d was performed, using a 2:1 randomization ratio, in 51 SLE patients. The primary outcome measures were change in the Automated Neuropsychological Assessment Metrics throughput scores at 12 weeks. RESULTS: There were no statistically significant differences between treatment groups or change from baseline in any of the Automated Neuropsychological Assessment Metrics throughput scores at 6 or 12 weeks. For the American College of Rheumatology cognitive battery, the only statistically significant findings were for the Controlled Oral Word Association Test-S words at 6 and 12 weeks. At 12 weeks, the memantine group exhibited greater improvement compared with the placebo group (3.6 ± 1.8 vs 0.5 ± 3.8 words, P = 0.03). In a subset analysis limited to patients that scored ≥1 standard deviation below normal controls at baseline, no significant differences between treatment groups were found. CONCLUSIONS: In this first clinical trial of memantine in SLE, patients treated with memantine did not exhibit significant improvement in cognitive performance compared with the placebo group, regardless of the degree of impairment at baseline, with the exception of controlled oral word association.

Depression and cognitive impairment in newly diagnosed systemic lupus erythematosus.

OBJECTIVE: Cognitive impairment is present in 80% of patients with systemic lupus erythematosus (SLE) 10 years after diagnosis. The natural history of cognitive dysfunction in newly diagnosed SLE is unknown. We examined the association of depression and cognitive performance in newly diagnosed SLE. METHODS: A multicenter cohort of 111 patients newly diagnosed (within 9 months) with SLE underwent cognitive function testing using an automated battery [Automated Neuropsychological Assessment Metrics (ANAM)] with 9 subtests. Depression was measured using the Calgary Depression Scale (CDS). RESULTS: The patient cohort was 97.3% female, 55.9% white, 15.3% African American, 20.7% Hispanic, mean age 37.8 years, mean education 15.2 years. CDS score ranged from 0 to 18 (mean 5.0 ± 4.6). CDS score did not differ by age, sex, ethnicity, or prednisone dose. Higher Krupp Fatigue Severity Scale scores and presence of fibromyalgia were significantly associated with higher CDS score (p < 0.001; p = 0.006, respectively). Depressed patients, defined by a CDS score > 6, had significantly poorer performance on 5 ANAM throughput measures: code substitution (p = 0.03), continuous performance (p = 0.02), matching-to-sample (p = 0.04), simple reaction time (p = 0.02), and the Sternberg memory test (p = 0.04). Adjusting for age, sex, ethnicity, education, and prednisone dose, a higher CDS score remained significantly associated with poorer performance on 3 measures, but the association was slightly attenuated for code substitution and matching-to-sample. Depression was not associated with mathematical or spatial processing. CONCLUSION: Depression, a modifiable risk factor, is associated with significantly poorer function in several cognitive domains in patients newly diagnosed with SLE. Treatment of depression when the CDS score is greater than 6 may improve cognitive functioning and should be further studied.

Brain magnetic resonance imaging in newly diagnosed systemic lupus erythematosus.

OBJECTIVE: We wished to determine the prevalence of cerebral atrophy and focal lesions in a cohort of patients with newly diagnosed systemic lupus erythematosus (SLE) and the association of these brain abnormalities with clinical characteristics. METHODS: A total of 97 patients with SLE, within 9 months of diagnosis, with 4 or more American College of Rheumatology classification criteria, were enrolled. Brain magnetic resonance imaging was performed. RESULTS: The patients were 97% female, mean age 38.1 (SD 12.2) years, education 15.1 (2.8) years; 59 Caucasian, 11 African American, 19 Hispanic, 5 Asian, and 3 other ethnicity. Cerebral atrophy was prevalent in 18% (95% CI 11%-27%): mild in 12%, moderate in 5%. Focal lesions were prevalent in 8% (95% CI 4%-16%): mild in 2%, moderate in 5%, severe in 1%. Patients with cerebral atrophy were more likely to have anxiety disorder (p = 0.04). Patients with focal lesions were more likely to be African American (p = 0.045) and had higher Safety of Estrogens in Lupus Erythematosus National Assessment SLEDAI scores (p = 0.02) and anti-dsDNA (p = 0.05). CONCLUSION: In this population with newly diagnosed SLE, brain abnormalities were prevalent in 25% of patients. These findings suggest that the brain may be affected extremely early in the course of SLE, even before the clinical diagnosis of SLE is made. Followup of these patients is planned, to determine the reversibility or progression of these abnormalities and their association with and potential predictive value for subsequent neuropsychiatric SLE manifestations.

Cognitive function in a systemic lupus erythematosus inception cohort.

OBJECTIVE: Measurable cognitive impairment occurs in 30-75% of patients with systemic lupus erythematosus (SLE). We compared cognitive functioning in recently-diagnosed SLE patients and normal controls. METHODS: The Automated Neuropsychological Assessment Metrics (ANAM), a repeatable computerized cognitive battery assessing cognitive processing speed and efficiency, was administered to 111 recently diagnosed SLE patients and 79 normal controls. Throughput scores on ANAM subtests were compared using linear regression. RESULTS: After adjusting for age, gender, ethnicity, and education, SLE patients scored significantly lower than controls on throughput measures of 4 ANAM subtests: code substitution immediate recall (p = 0.02), continuous performance (p = 0.02), matching to sample (p = 0.02), and Sternberg subtest (p = 0.0002). CONCLUSIONS: Recently diagnosed SLE patients performed significantly worse than normal controls on 4 of 9 ANAM subtests. ANAM subtests of cognitive efficiency requiring sustained attention/vigilance, visuospatial span of attention/working memory, and simple reaction time showed the greatest impairment. These cognitive deficits were particularly striking, because the SLE patients in this sample were not selected for the presence of neuropsychiatric manifestations, had mild SLE-related disease/damage, and were recently diagnosed with SLE. This suggests that deficits in cognitive efficiency and sustained attention are present early in the course of SLE and in the absence of other significant neuropsychiatric manifestations.

The effect of pain on health-related quality of life in the immediate postoperative period.

UNLABELLED: The hypothesis of this study was to determine if the severity of postoperative pain would affect patients' health-related quality of life (HRQL) in the immediate postoperative period (within 2 wk of surgery). We designed this study as a prospective, nonrandomized observational trial in a tertiary academic care center. Patients undergoing elective total hip or knee replacement surgery were eligible. Patients received a standardized intraoperative general or epidural anesthetic followed by IV patient-controlled analgesia or patient-controlled epidural analgesia. Short Form (SF)-12, visual analog scores for pain at rest and pain with activity, nausea, and itching were assessed on postoperative days 1-5, 7, and 14. The severity of pain correlated with a decrease in both the physical and mental component of the SF-12. The severity of nausea correlated with a decrease in the mental but not physical component of the SF-12. The severity of itching did not correlate with a change in the SF-12. Our findings suggest that an increase in postoperative pain will decrease a patient's quality of life in the immediate postoperative period; however, several methodologic issues exist when assessing HRQL in the immediate postoperative period. IMPLICATIONS: Severity of postoperative pain may affect quality of life.

Sympathoadrenal imbalance before neurocardiogenic syncope.

Neurocardiogenic syncope is the most common cause of acute loss of consciousness in adults. The present study attempted to identify neuroendocrine and hemodynamic changes before syncope that could therefore play a pathophysiologic role. Twenty-five patients referred for chronic orthostatic intolerance had plasma catecholamines measured serially; 21 patients during tilt-table testing (evoking syncope in 13) and 4 others with spontaneous syncope while supine. Forearm blood flow was measured by impedance plethysmography. All 12 patients with blood sampled before tilt-induced syncope had progressive, marked increases in plasma epinephrine levels (mean 11 times baseline, p <0.0001) before syncope. Simultaneously obtained norepinephrine levels increased to a much smaller extent than did epinephrine levels ("sympathoadrenal imbalance"). In the same patients, forearm vascular resistance decreased by 21% before syncope. Proportionate changes in forearm vascular resistance before syncope correlated negatively with those in the epinephrine:norepinephrine ratio (r = -0.75, p = 0.005). Patients without syncope had forearm vasoconstriction and no sympathoadrenal imbalance during tilt. Patients with syncope while supine also had sympathoadrenal imbalance before loss of consciousness. Sympathoadrenal imbalance precedes tilt-evoked and spontaneous neurocardiogenic syncope and correlates with concurrent skeletal muscle vasodilation. Sympathoadrenal imbalance may contribute to hemodynamic derangements precipitating neurocardiogenic syncope.