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1.
Am J Infect Control ; 51(11S): A158-A163, 2023 11.
Article En | MEDLINE | ID: mdl-37890947

OBJECTIVE: To determine the relationship between home disinfectant use and the prevalence of antibiotic resistance among environmental isolates of human pathogens. METHODS: Bacteria were cultured from 5 kitchen and 5 bathroom sites using quantitative methods. Antibiotic susceptibility was determined by standard methods. Home disinfectant use was assessed via a questionnaire. RESULTS: The overall total mean log10 counts (total CFU) for the kitchen and bathroom were 4.31 and 4.88, respectively. Gram-positive bacteria were more common in the bathroom (4.05) than in the kitchen (3.60), while Gram-negative bacilli were more common in the kitchen (4.23) than in the bathroom (3.86). The sink and bath drains were the most contaminated sites with 6.16-log10 of total CFU and 6.6-log10 in the kitchen and bathroom, respectively. Households reported cleaning frequency with a variety of commercial products. Most respondents used antibacterial products (eg, soaps, surface disinfectants) in the home. Antibiotic-resistant pathogens were infrequently isolated in the homes evaluated. CONCLUSIONS: Compared to pathogens causing community-acquired clinical infections in the ICARE study, pathogens isolated from households are less likely to demonstrate antibiotic resistance. In addition, no relationship between antibacterial use or frequency of cleaning or disinfection and antibiotic resistance was revealed.


Disinfectants , Humans , Disinfectants/pharmacology , Anti-Bacterial Agents/pharmacology , Toilet Facilities , Drug Resistance, Microbial , Gram-Negative Bacteria
2.
J Pain Symptom Manage ; 66(6): e672-e686, 2023 12.
Article En | MEDLINE | ID: mdl-37666368

CONTEXT: The CONSORT guideline defines a pilot trial as a small-scale version of a desired future efficacy trial that is intended to answer the key questions of whether and how a larger study should be done. For example, a pilot trial might evaluate different approaches to data collection or outcome measurement. However, pilot trials are unreliable for assessing treatment efficacy due to the statistical phenomenon called sampling variability. OBJECTIVES: In this tutorial we use computer simulation to demonstrate the influence of sampling variability on efficacy estimates from pilot trials, illustrating why pilot trial designs should not be used to evaluate whether a treatment is promising or not. METHODS: We simulate a 2-arm parallel group trial (N=20 per group) with a survival outcome as an example. Simulations are done under two scenarios: 1) the treatment is efficacious at the level of a hypothetical minimum clinically important difference (hazard ratio [HR] = 0.75); and 2) the treatment is not efficacious (HR=1). RESULTS: As expected, in both simulated scenarios the range of observed results is distributed around the true treatment effect, HR=0.75 or HR=1. Importantly, ∼20% of trials simulated under scenario 1 incorrectly suggest the treatment may be harmful (HR > 1). Under scenario 2, half of the simulated studies incorrectly suggest the treatment is beneficial. CONCLUSION: Treatment effect estimates from pilot trials should not be used to make future development decisions regarding a novel therapy because of the high risk of misleading conclusions.


Computer Simulation , Humans , Pilot Projects , Treatment Outcome , Proportional Hazards Models
3.
Account Res ; 30(4): 252-259, 2023 05.
Article En | MEDLINE | ID: mdl-34569387

Questionable research practices (QRP) are actions taken by researchers that span a range of concern related to violation of research best practices, and ultimately expose institutions and research participants to risk. Numerous studies have shown that QRP are common. The continued prevalence of QRP indicates that existing approaches for dealing with QRP are falling short. In this editorial we discuss the risks associated with QRP and propose mitigation strategies at the institutional level using a common QRP as an example, questionable treatment of subgroup analyses. We argue that the need for institutional intervention in cases such as this are particularly motivating when both the investigator and the institution have a substantial financial conflict of interest related to intellectual property that requires the investigator's expertise to continue developing. To address this, we propose an expansion of the traditional conflict of interest management process.


Conflict of Interest , Research Personnel , Humans
4.
J Pain Symptom Manage ; 63(6): e749-e755, 2022 06.
Article En | MEDLINE | ID: mdl-35235856

This is a tutorial on designing a persuasive pilot study of a psychosocial intervention (e.g., behavioral symptom management) in the palliative care setting. This tutorial is most relevant for early stages of intervention research that aims to progress toward a randomized controlled trial with a high degree of internal validity. Broadly, a pilot study aims to address multiple elements of feasibility and acceptability so that investigators are well positioned for the next study in their program of research. To assist investigators in writing compelling grant applications we designed this tutorial as an annotated checklist of goals that a pilot study within the palliative care domain should seek to accomplish. These goals include the following: 1) begin with the end in mind, 2) use a formal conceptual model, 3) use measures with strong psychometric properties, 4) justify the timing of study sessions and assessments, 5) test recruitment methods, 6) estimate retention, 7) assess interventionist fidelity, 8) assess acceptability of the intervention, 9) assess feasibility, and 10) identify barriers to the next study. We elaborate on these goals by describing an ongoing pilot study testing the feasibility and acceptability of a psychosocial pain management intervention for patients with advanced cancer. Pilot studies are crucial for building a successful program of research, but they are also limited in terms of their sample size and overall objectives. A persuasive pilot study is one that is limited yet useful rather than limited and trivial.


Hospice and Palliative Care Nursing , Palliative Care , Feasibility Studies , Humans , Palliative Care/methods , Pilot Projects , Psychosocial Intervention , Randomized Controlled Trials as Topic
5.
Front Cardiovasc Med ; 8: 638929, 2021.
Article En | MEDLINE | ID: mdl-33869303

Background: The goal was studying the differential effects of aerobic training (AT) vs. resistance training (RT) on cardiac and peripheral arterial capacity on cardiopulmonary (CP) and peripheral vascular (PV) function in sedentary and obese adults. Methods: In a prospective randomized controlled trial, we studied the effects of 6 months of AT vs. RT in 21 subjects. Testing included cardiac and vascular ultrasoundography and serial CP for ventricular-arterial coupling (Ees/Ea), strain-based variables, brachial artery flow-mediated dilation (BAFMD), and peak VO2 (pVO2; mL/kg/min) and peak O2-pulse (O2p; mL/beat). Results: Within the AT group (n = 11), there were significant increases in rVO2 of 4.2 mL/kg/min (SD 0.93) (p = 0.001); O2p of 1.9 mL/beat (SD 1.3) (p = 0.008) and the brachial artery post-hyperemia peak diameter 0.18 mm (SD 0.08) (p = 0.05). Within the RT group (n = 10) there was a significant increase in left ventricular end diastolic volume 7.0 mL (SD 9.8; p = 0.05) and percent flow-mediated dilation (1.8%) (SD 0.47) (p = 0.004). Comparing the AT and RT groups, post exercise, rVO2 2.97, (SD 1.22), (p = 0.03), O2p 0.01 (SD 1.3), (p = 0.01), peak hyperemic blood flow volume (1.77 mL) (SD 140.69) (p = 0.009), were higher in AT, but LVEDP 115 mL (SD 7.0) (p = 0.05) and Ees/Ea 0.68 mmHg/ml (SD 0.60) p = 0.03 were higher in RT. Discussion: The differential effects of AT and RT in this hypothesis generating study have important implications for exercise modality and clinical endpoints.

6.
Contemp Clin Trials ; 102: 106287, 2021 03.
Article En | MEDLINE | ID: mdl-33497833

BACKGROUND: Women with breast cancer in medically underserved areas are particularly vulnerable to persistent pain and disability. Behavioral pain interventions reduce pain and improve outcomes. Cancer patients in medically underserved areas receive limited adjunctive cancer care, as many lack access to pain therapists trained in behavioral interventions, face travel barriers to regional medical centers, and may have low literacy and limited resources. mHealth technologies have the potential to decrease barriers but must be carefully adapted for, and efficacy-tested with, medically underserved patients. We developed an mHealth behavioral pain coping skills training intervention (mPCST-Community). We now utilize a multisite randomized controlled trial to: 1) test the extent mPCST-Community reduces breast cancer patients' pain severity (primary outcome), pain interference, fatigue, physical disability, and psychological distress; 2) examine potential mediators of intervention effects; and 3) evaluate the intervention's cost and cost-effectiveness. METHODS/DESIGN: Breast cancer patients (N = 180) will be randomized to mPCST-Community or an attention control. mPCST-Community's four-session protocol will be delivered via videoconferencing at an underserved community clinic by a remote pain therapist at a major medical center. Videoconference sessions will be supplemented with a mobile application. Participants will complete self-report measures at baseline, post-intervention, and 3- and 6-month follow-ups. CONCLUSIONS: mPCST-Community has the potential to reduce pain and disability, and decrease barriers for cancer patients in medically underserved areas. This is one of the first trials to test an mHealth behavioral cancer pain intervention developed specifically for medically underserved communities. If successful, it could lead to widespread implementation and decreased health disparities.


Breast Neoplasms , Cancer Pain , Mobile Applications , Adaptation, Psychological , Breast Neoplasms/complications , Breast Neoplasms/therapy , Female , Humans , Medically Underserved Area , Prospective Studies , Videoconferencing
7.
Support Care Cancer ; 29(7): 3563-3569, 2021 Jul.
Article En | MEDLINE | ID: mdl-33159220

PURPOSE: Acute myeloid leukemia (AML) is a hematologic malignancy characterized by a poor prognosis but also a paradoxical possibility of cure. This renders decision-making complex and imminent. Unfortunately, many patients with AML misestimate their prognosis and treatment risk. While decision aids can improve illness understanding and reduce decisional conflict, there are no validated decision aids for AML. We developed and tested a novel AML decision aid (NCT03442452). METHODS: Patients (n = 20) were recruited at Duke University from May 2018 to February 2019. Participants completed assessments of AML knowledge and decisional conflict, before and after using the electronic decision aid. The primary endpoint was feasibility (endpoint met if > 80% of study participants completed all study components). Secondary analyses of efficacy were conducted using paired t tests for dependent pre-/post-samples. RESULTS: The primary endpoint of feasibility was met (100% of participants completed all study components). Secondary analyses showed improved knowledge and reduced decisional conflict after using the decision aid. Knowledge scores improved from a mean of 11.8 (out of 18) correct items at baseline to 15.1 correct items after using the decision aid (mean difference 3.35; p < 0.0001). Decisional conflict scores reduced significantly from baseline to post-test as well (mean difference - 6.5; p = 0.02). CONCLUSION: These findings suggest that our AML decision aid is a useful tool to improve the patient experience and promote shared decision-making in AML. A randomized efficacy trial is planned.


Decision Making/ethics , Decision Support Techniques , Health Knowledge, Attitudes, Practice , Leukemia, Myeloid, Acute/therapy , Female , Humans , Knowledge , Male , Middle Aged
8.
J Pain Symptom Manage ; 61(4): 858-863, 2021 04.
Article En | MEDLINE | ID: mdl-33246075

This is a short tutorial on two key questions that pertain to cluster randomized trials (CRTs): 1) Should I perform a CRT? and 2) If so, how do I derive the sample size? In summary, a CRT is the best option when you "must" (e.g., the intervention can only be administered to a group) or you "should" (e.g., because of issues such as feasibility and contamination). CRTs are less statistically efficient and usually more logistically complex than individually randomized trials, and so reviewing the rationale for their use is critical. The most straightforward approach to the sample size calculation is to first perform the calculation as if the design were randomized at the level of the patient and then to inflate this sample size by multiplying by the "design effect", which quantifies the degree to which responses within a cluster are similar to one another. Although trials with large numbers of small clusters are more statistically efficient than those with a few large clusters, trials with large clusters can be more feasible. Also, if results are to be compared across individual sites, then sufficient sample size will be required to attain adequate precision within each site. Sample size calculations should include sensitivity analyses, as inputs from the literature can lack precision. Collaborating with a statistician is essential. To illustrate these points, we describe an ongoing CRT testing a mobile-based app to systematically engage families of intensive care unit patients and help intensive care unit clinicians deliver needs-targeted palliative care.


Critical Care , Intensive Care Units , Cluster Analysis , Humans , Randomized Controlled Trials as Topic , Research Design , Sample Size
9.
Learn Health Syst ; 4(3): e10219, 2020 Jul.
Article En | MEDLINE | ID: mdl-32685686

We consider four memes, correct within the context of randomized trials but requiring modification for the analysis of the observational databases typically associated with learning health systems: (a) the right answer always requires randomization; (b) a bigger database is always a better database; (c) statistical adjustment always works if based on a large enough database; and (d) always make a formal adjustment when testing multiple hypotheses. The rationale for these memes within the context of randomized trials is discussed, and the memes are restated in a fashion that is consistent with learning health systems.

10.
J Stroke Cerebrovasc Dis ; 29(4): 104646, 2020 Apr.
Article En | MEDLINE | ID: mdl-32067855

BACKGROUND: African-Americans (AA) are 3 times more likely to have small-vessel-type ischemic strokes (SVS) than Whites. Small vessel strokes are associated with cognitive impairment, a relationship incompletely explained by white matter hyperintensity (WMH) burden. We examined whether inflammatory/endothelial dysfunction biomarkers are associated with cognition after SVS in AAs. METHODS: Biomarkers were obtained in 24 subjects (median age 56.5 years, 54% women, median 12 years education). Cognition was assessed more than 6 weeks poststroke using the memory composite score (MCS), which was generated using recall from the Hopkins Verbal Learning Test-II and Brief Visuospatial Memory Test-Revised. A semi-automated, volumetric protocol was used to quantify WMH volume (WMHv) on clinical MRI scans. Potential biomarkers including vascular cell adhesion molecule-1 (VCAM-1), interleukin-1 receptor antagonist, interleukin-6, interleukin-8, interleukin-10, interferon gamma, and thrombin-antithrombin (TAT) were log-transformed and correlated with MCS with adjustment for potential confounders. RESULTS: Among serum biomarkers, only VCAM-1-correlated with poorer memory based on the MCS (r = -.659; P = .0006). VCAM-1 (r = .554; P = .005) and age (r = .479; P = .018) correlated with WMHv; VCAM-1 was independently associated with MCS after adjustment for WMHv, age, and education (P = .023). CONCLUSIONS: The findings of this exploratory analysis suggest that endothelial dysfunction and inflammation as reflected by VCAM-1 levels may play a role in poststroke cognitive impairment. Additional studies are needed to validate this observation and to evaluate this relationship in non-AAs and with other stroke types and compare this finding to cognitive impairment in nonstroke populations.


Black or African American/psychology , Cerebral Small Vessel Diseases/blood , Memory Disorders/blood , Memory , Stroke/blood , Vascular Cell Adhesion Molecule-1/blood , Biomarkers/blood , Cerebral Small Vessel Diseases/diagnosis , Cerebral Small Vessel Diseases/ethnology , Cerebral Small Vessel Diseases/psychology , Female , Humans , Male , Memory Disorders/diagnosis , Memory Disorders/ethnology , Memory Disorders/psychology , Middle Aged , Neuropsychological Tests , Risk Factors , Stroke/diagnosis , Stroke/ethnology , Stroke/psychology , United States/epidemiology
11.
Support Care Cancer ; 28(11): 5099-5107, 2020 Nov.
Article En | MEDLINE | ID: mdl-32040637

PURPOSE: Utilization of electronic patient-reported outcomes (ePROs) in the clinic can improve quality of life and prolong survival in cancer care. However, there remain unanswered questions regarding trends in missing data and the potential effect on real-time patient care. METHODS: This study utilized a prospectively collected dataset of ePROs from oncology clinics that administered the Patient Care Monitor 2.0 (PCM), a validated symptoms survey assessing 78 items for men, and 86 for women. We tabulated the frequency of missing items, by item and domain (emotional, functional and physical symptom-related), and examined these by age, gender, education, race and marital status. RESULTS: Within 20,986 encounters, there were responses to at least 1 PCM item from 6933 unique patients. The highest frequency of missing answers occurred for: "attend a paid job" (10.7%), "reduced sexual enjoyment" (3.8%), and "run" (3.7%). By domain, 12.3% of functional, 8.4% of physical symptom-related, and 1.6% of emotional constructs contained at least one missing item. For functional and physical symptom-related items, missingness was most common in patients >60 years old. CONCLUSION: The frequency of missingness was highest for functional items, like attending a paid job, suggesting that some respondents (e.g., retirees without a paid job) skipped questions that were less applicable to them. More universal issues for cancer patients, such as emotional well-being, had much lower frequencies of missingness. This suggests differential item completion that warrants further study to understand the inherent drivers. Identifying causes of missingness could improve the clinical utility of ePROs and highlight opportunities to personalize care.


Data Interpretation, Statistical , Electronic Health Records , Neoplasms/diagnosis , Neoplasms/therapy , Patient Reported Outcome Measures , Adult , Data Collection/methods , Databases, Factual , Female , Humans , Male , Mental Health , Middle Aged , Neoplasms/psychology , Quality of Life , Surveys and Questionnaires
12.
HPB (Oxford) ; 21(12): 1667-1675, 2019 12.
Article En | MEDLINE | ID: mdl-31155452

BACKGROUND: Approximately 38% of patients with colorectal cancer will develop isolated liver metastases. Sidedness of colon tumor is identified in non-metastatic and unresected metastatic cancers as predictive of survival, yet its dedicated analysis in resected liver metastases is minimal. Our primary aim was to assess whether left-sided primary tumors improve prognosis in stage IV cancer patients undergoing curative-intent liver metastasectomy; it was hypothesized that it would. METHODS: This is a retrospective, observational cohort study from 1996 to 2016 in a single tertiary-care facility. Survival from diagnosis was calculated via Kaplan-Meier method and compared between the right and left sides via log-rank analysis. RESULTS: Median survival differs significantly between colorectal tumors of the right and left origins after hepatic metastasectomy in 612 patients. In patients with right-sided tumors, median survival from diagnosis was 4.5 years (IQR 4.1-5.3), and 6.3 years (IQR 5.6-6.9) in those with left tumors (HR 1.5, 95% CI 1.38-1.60, p < 0.001). CONCLUSION: As in studies on earlier-stage or unresected metastatic disease, tumor sidedness is an important prognostic factor in patient survival with liver metastasectomy. Clinical risk scores should include side of primary tumor. Further work is needed to determine the molecular basis for this difference.


Colorectal Neoplasms/mortality , Colorectal Neoplasms/pathology , Liver Neoplasms/mortality , Liver Neoplasms/secondary , Aged , Chemotherapy, Adjuvant/statistics & numerical data , Cohort Studies , Female , Hepatectomy , Humans , Kaplan-Meier Estimate , Liver Neoplasms/surgery , Male , Middle Aged , Neoadjuvant Therapy/statistics & numerical data , Retrospective Studies
14.
Support Care Cancer ; 27(10): 3897-3904, 2019 Oct.
Article En | MEDLINE | ID: mdl-30762144

PURPOSE: Pruritus is a common symptom in cutaneous malignancies, but its impact on patients with solid tumors is unclear. We explored the impact and management of pruritus in patients with solid tumors, using patient-reported outcomes (PRO) data from a real-world registry. METHODS: From 2006 to 2011, patients seen in the Duke Cancer Institute reported their symptoms via the Patient Care Monitor v2.0, a validated PRO tool that includes a 0-10-point question about pruritus severity. From > 25,000 encounters, 203 patients reported severe pruritus (> 6/10) on at least one visit and 506 total visits were abstracted where patients reported either moderate or severe pruritus (> 3/10). From this cohort, we abstracted demographics, diagnosis, stage, cancer therapy, anti-pruritic therapy, and clinicians' responses. RESULTS: Mean age was 59.8 (SD 13.3), 134 (66%) were female, 125 (62%) were Caucasian, and 65 (32%) were African American. Breast cancer was the most common tumor (36.5%), followed by lung cancer (23.2%). Mean pruritus severity score was 6.8 (SD 1.8) for patients on chemotherapy, 6.9 (SD 1.8) for patients on targeted therapy alone or in combination, and 7.1(SD 1.8) for patients off treatment. Overall, 67% of patients reported at least two episodes of moderate-severe pruritus (mean # of visits 4.2 (SD 2.7)). Despite frequent report of severe and persistent pruritus, this was mentioned in just 28% of clinician notes and an intervention was recommended/prescribed in only 7% of visits. CONCLUSIONS: Pruritus is an under-addressed symptom in patients with solid tumors. Additional research is needed to understand the burden of pruritus in affected populations.


Breast Neoplasms/pathology , Lung Neoplasms/pathology , Pruritus/diagnosis , Self Report/statistics & numerical data , Skin Neoplasms/pathology , Adult , Cohort Studies , Female , Humans , Male , Middle Aged , Pruritus/complications , Pruritus/therapy , Surveys and Questionnaires
15.
N C Med J ; 80(1): 7-11, 2019.
Article En | MEDLINE | ID: mdl-30622197

BACKGROUND Adoption of HIV pre-exposure prophylaxis (PrEP) remains limited among populations at greatest risk for HIV acquisition. This study aims to assess awareness of PrEP among individuals in Durham, North Carolina, which has one of the highest rates of HIV diagnoses in the state.METHOD In 2015-2016, we administered a survey including questions to assess PrEP awareness to individuals at multiple venues throughout Durham, North Carolina.RESULTS A total of 139 respondents were surveyed. The majority were male (66%) and black/African American (75%); 21% were Hispanic/Latino. There were an estimated 53 men who have sex with men (MSM), of which 18 (33%) were black MSM M 24 years of age. Overall, only 53/138 (38%) respondents were aware of PrEP. Awareness was reported among 33/52 (63%) MSM respondents, 29/46 (63%) black MSM, and 10/17 (59%) black MSM M 24 years of age. In multivariate analysis, non-heterosexual orientation, health-insured status, and prior HIV testing were significantly associated with PrEP awareness. Ninety-four (69%) of 137 respondents reported prior HIV testing.LIMITATIONS Limitations include non-random sampling and limited sample size. Further research needs to be done in other areas of North Carolina, and assessment of PrEP acceptability and uptake needs to be performed.CONCLUSION This study reveals low overall awareness of PrEP in Durham, North Carolina, indicating that expanded outreach is necessary to increase public awareness and encourage adoption of PrEP among all demographics at risk for HIV.


HIV Infections/prevention & control , Health Knowledge, Attitudes, Practice , Pre-Exposure Prophylaxis , Black or African American/psychology , Black or African American/statistics & numerical data , Female , Health Knowledge, Attitudes, Practice/ethnology , Hispanic or Latino/psychology , Hispanic or Latino/statistics & numerical data , Homosexuality, Male/ethnology , Homosexuality, Male/psychology , Homosexuality, Male/statistics & numerical data , Humans , Male , North Carolina , Surveys and Questionnaires
16.
JAMA Neurol ; 75(12): 1494-1501, 2018 12 01.
Article En | MEDLINE | ID: mdl-30167675

Importance: Data from animal models show that the administration of dextroamphetamine combined with task-relevant training facilitates recovery after focal brain injury. Results of clinical trials in patients with stroke have been inconsistent. Objectives: To collect data important for future studies evaluating the effect of dextroamphetamine combined with physiotherapy for improving poststroke motor recovery and to test the efficacy of the approach. Design, Setting, Participants: This pilot, double-blind, block-randomized clinical trial included patients with cortical or subcortical ischemic stroke and moderate or severe motor deficits from 5 rehabilitation hospitals or units. Participants were screened and enrolled from March 2001 through March 2003. The primary outcome was assessed 3 months after stroke. Study analysis was completed December 31, 2015. A total of 1665 potential participants were screened and 64 were randomized. Participants had to begin treatment 10 to 30 days after ischemic stroke. Data analysis was based on intention to treat. Interventions: Participants were allocated to a regimen of 10 mg of dextroamphetamine (n = 32) or placebo (n = 32) combined with a 1-hour physical therapy session beginning 1 hour after drug or placebo administration every 4 days for 6 sessions in addition to standard rehabilitation. Main Outcomes and Measures: The primary outcome was the difference between groups in change in Fugl-Meyer motor scores from baseline to 3 months after stroke (intention to treat with dextroamphetamine). Secondary exploratory measures included the National Institutes of Health Stroke Scale, Canadian Neurological Scale, Action Research Arm Test, modified Rankin Scale score, Functional Independence Measure, Ambulation Speed and Distance, Mini-Mental State Examination, Beck Depression Inventory, and Stroke Impact Scale. Results: Among the 64 patients randomized to dextroamphetamine vs placebo (55% men; median age, 66 years; age range, 27-91 years), no overall treatment-associated difference in the mean (SEM) change in Fugl-Meyer motor scores from baseline to 3 months after stroke was noted (-18.65 [2.27] points with dextroamphetamine vs -20.83 [2.94] points with placebo; P = .58). No overall treatment-associated differences in any of the study's secondary measures and no differences in subgroups based on stroke location or baseline severity were found. No adverse events were attributed to study treatments. Conclusions and Relevance: Treatment with dextroamphetamine combined with physical therapy did not improve recovery of motor function compared with placebo combined with physical therapy as assessed 3 months after hemispheric ischemic stroke. The studied treatment regimen was safe. Trial Registration: ClinicalTrials.gov identifier: NCT01905371.


Central Nervous System Stimulants/pharmacology , Dextroamphetamine/pharmacology , Outcome Assessment, Health Care , Physical Therapy Modalities , Recovery of Function , Stroke Rehabilitation/methods , Stroke/drug therapy , Adult , Aged , Aged, 80 and over , Brain Ischemia/complications , Central Nervous System Stimulants/administration & dosage , Combined Modality Therapy , Dextroamphetamine/administration & dosage , Double-Blind Method , Female , Humans , Male , Middle Aged , Pilot Projects , Severity of Illness Index , Stroke/etiology
17.
JMIR Mhealth Uhealth ; 6(3): e66, 2018 Mar 19.
Article En | MEDLINE | ID: mdl-29555620

BACKGROUND: Pain is a challenge for patients following hematopoietic stem cell transplantation (HCT). OBJECTIVE: This study aimed to develop and test the feasibility, acceptability, and initial efficacy of a Web-based mobile pain coping skills training (mPCST) protocol designed to address the needs of HCT patients. METHODS: Participants had undergone HCT and reported pain following transplant (N=68). To guide intervention development, qualitative data were collected from focus group participants (n=25) and participants who completed user testing (n=7). After their input was integrated into the mPCST intervention, a pilot randomized controlled trial (RCT, n=36) was conducted to examine the feasibility, acceptability, and initial efficacy of the intervention. Measures of acceptability, pain severity, pain disability, pain self-efficacy, fatigue, and physical disability (self-report and 2-min walk test [2MWT]) were collected. RESULTS: Participants in the focus groups and user testing provided qualitative data that were used to iteratively refine the mPCST protocol. Focus group qualitative data included participants' experiences with pain following transplant, perspectives on ways to cope with pain, and suggestions for pain management for other HCT patients. User testing participants provided feedback on the HCT protocol and information on the use of videoconferencing. The final version of the mPCST intervention was designed to bridge the intensive outpatient (1 in-person session) and home settings (5 videoconferencing sessions). A key component of the intervention was a website that provided personalized messages based on daily assessments of pain and activity. The website also provided intervention materials (ie, electronic handouts, short videos, and audio files). The intervention content included pain coping advice from other transplant patients and instructions on how to apply pain coping skills while engaging in meaningful and leisure activities. In the RCT phase of this research, HCT patients (n=36) were randomized to receive the mPCST intervention or to proceed with the treatment as usual. Results revealed that the mPCST participants completed an average of 5 out of 6 sessions. The participants reported that the intervention was highly acceptable (mean 3/4), and they found the sessions to be helpful (mean 8/10) and easy to understand (mean 7/7). The mPCST participants demonstrated significant improvements in pre- to post-treatment pain, self-efficacy (P=.03, d=0.61), and on the 2MWT (P=.03, d=0.66), whereas the patients in the treatment-as-usual group did not report any such improvements. Significant changes in pain disability and fatigue were found in both groups (multiple P<.02); the magnitudes of the effect sizes were larger for the mPCST group than for the control group (pain disability: d=0.79 vs 0.69; fatigue: d=0.94 vs 0.81). There were no significant changes in pain severity in either group. CONCLUSIONS: Using focus groups and user testing, we developed an mPCST protocol that was feasible, acceptable, and beneficial for HCT patients with pain. TRIAL REGISTRATION: ClinicalTrials.gov NCT01984671; https://clinicaltrials.gov/ct2/show/NCT01984671 (Archived by WebCite at http://www.webcitation.org/6xbpx3clZ).

18.
J Palliat Med ; 21(6): 789-795, 2018 06.
Article En | MEDLINE | ID: mdl-29420142

BACKGROUND: Little is known about quality of life (QOL), depression, and end-of-life (EOL) outcomes among hospitalized patients with advanced cancer. OBJECTIVE: To assess whether the surprise question identifies inpatients with advanced cancer likely to have unmet palliative care needs. DESIGN: Prospective cohort study and long-term follow-up. SETTING/SUBJECTS: From 2008 to 2010, we enrolled 150 inpatients at Duke University with stage III/IV solid tumors or lymphoma/acute leukemia and whose physician would not be surprised if they died in less than one year. MEASUREMENTS: We assessed QOL (FACT-G), mood (brief CES-D), and EOL outcomes. RESULTS: Mean FACT-G score was quite low (66.9; SD 11). Forty-five patients (30%) had a brief CES-D score of ≥4 indicating a high likelihood of depression. In multivariate analyses, better QOL was associated with less depression (OR 0.91, p < 0.0001), controlling for tumor type, education, and spiritual well-being. Physicians correctly estimated death within one year in 101 (69%) cases, yet only 37 patients (25%) used hospice, and 4 (2.7%) received a palliative care consult; 89 (60.5%) had a do-not-resuscitate order, and 63 (43%) died in the hospital. CONCLUSIONS: The surprise question identifies inpatients with advanced solid or hematologic cancers having poor QOL and frequent depressive symptoms. Although physicians expected death within a year, EOL quality outcomes were poor. Hospitalized patients with advanced cancer may benefit from palliative care interventions to improve mood, QOL, and EOL care, and the surprise question is a practical method to identify those with unmet needs.


Depressive Disorder/psychology , Hematologic Neoplasms/nursing , Inpatients/psychology , Needs Assessment/statistics & numerical data , Neoplasms/nursing , Palliative Care/psychology , Quality of Life/psychology , Adult , Aged , Cohort Studies , Female , Humans , Male , Middle Aged , North Carolina , Prospective Studies
19.
Support Care Cancer ; 26(5): 1437-1445, 2018 May.
Article En | MEDLINE | ID: mdl-29151174

PURPOSE: Shared decision-making in acute myeloid leukemia (AML) requires understanding patients' longitudinal experiences of illness, but little is known about the impact of remission status on patient-reported outcomes (PROs). We aimed to explore the association between remission status and PROs 6-12 months following induction chemotherapy. METHODS: Forty-two patients completed three validated instruments characterizing symptom burden (Patient Care Monitor v2.0), distress (NCCN Distress Thermometer), and QOL (FACT-Leu), as part of a longitudinal observational study. We used regression models to explore the relationship between remission status and PROs, and explore differences by initial disease type (de novo versus secondary/relapsed AML). RESULTS: Those with secondary or relapsed AML at study onset had marked impairments in all measures compared to de novo AML patients. After 6 months, their mean distress score was 4.8 (> 4.0 warrants intervention), they reported a mean of 14.1 moderate/severe symptoms and had a mean QOL score of 113.6, compared to 1.0, 1.7, and 155.2, respectively, for those with de novo AML (p < .0001). Similarly, patients in relapse had a mean distress score of 5.3, a mean of 12.8 moderate/severe symptoms, and a mean QOL score of 113.4, compared to 1.8, 5.7, and 143.8, respectively, among those in remission (p < .005). These patterns persisted after adjusting for baseline differences (p < .0001). CONCLUSION: Remission is associated with markedly better patient well-being in AML. Patients with secondary or relapsed AML face more severe symptom burden, distress, and QOL issues after induction. Interventions are needed to improve AML patients' experiences of illness.


Leukemia, Myeloid, Acute/drug therapy , Patient Reported Outcome Measures , Quality of Life/psychology , Remission Induction/methods , Female , Humans , Male , Middle Aged
20.
J Am Coll Health ; 65(3): 223-227, 2017 Apr.
Article En | MEDLINE | ID: mdl-28059669

OBJECTIVE: To investigate sexual orientation differences in college men's motivations for HIV testing. PARTICIPANTS: 665 male college students in the Southeastern United States from 2006 to 2014. METHODS: Students completed a survey on HIV risk factors and testing motivations. Logistic regressions were conducted to determine the differences between heterosexual men (HM) and sexual minority men (SMM). RESULTS: SMM were more motivated to get tested by concern over past condomless sex, while HM were more often cited supporting the testing program "on principle" and wanting a free t-shirt. SMM and HM differed in behaviors that impact HIV risk and other demographics. However, differences in testing motivation by concern over past condomless sex or wanting a free t-shirt persisted when controlling for these demographic and behavioral differences. CONCLUSIONS: Appropriately designed HIV prevention interventions on college campuses should target SMM's distinct concern over past condomless sex as a testing motivation.


Diagnostic Tests, Routine/statistics & numerical data , HIV Infections/diagnosis , Motivation , Sexual Behavior/statistics & numerical data , Adolescent , Humans , Logistic Models , Male , Southeastern United States , Students/statistics & numerical data , Surveys and Questionnaires , Universities/organization & administration , Universities/statistics & numerical data , Young Adult
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