Association between cervical artery dissection and spinal manipulative therapy -a medicare claims analysis.

BACKGROUND: Cervical artery dissection and subsequent ischemic stroke is the most serious safety concern associated with cervical spinal manipulation. METHODS: We evaluated the association between cervical spinal manipulation and cervical artery dissection among older Medicare beneficiaries in the United States. We employed case-control and case-crossover designs in the analysis of claims data for individuals aged 65+, continuously enrolled in Medicare Part A (covering hospitalizations) and Part B (covering outpatient encounters) for at least two consecutive years during 2007-2015. The primary exposure was cervical spinal manipulation; the secondary exposure was a clinical encounter for evaluation and management for neck pain or headache. We created a 3-level categorical variable, (1) any cervical spinal manipulation, 2) evaluation and management but no cervical spinal manipulation and (3) neither cervical spinal manipulation nor evaluation and management. The primary outcomes were occurrence of cervical artery dissection, either (1) vertebral artery dissection or (2) carotid artery dissection. The cases had a new primary diagnosis on at least one inpatient hospital claim or primary/secondary diagnosis for outpatient claims on at least two separate days. Cases were compared to 3 different control groups: (1) matched population controls having at least one claim in the same year as the case; (2) ischemic stroke controls without cervical artery dissection; and (3) case-crossover analysis comparing cases to themselves in the time period 6-7 months prior to their cervical artery dissection. We made each comparison across three different time frames: up to (1) 7 days; (2) 14 days; and (3) 30 days prior to index event. RESULTS: The odds of cervical spinal manipulation versus evaluation and management did not significantly differ between vertebral artery dissection cases and any of the control groups at any of the timepoints (ORs 0.84 to 1.88; p > 0.05). Results for carotid artery dissection cases were similar. CONCLUSION: Among Medicare beneficiaries aged 65 and older who received cervical spinal manipulation, the risk of cervical artery dissection is no greater than that among control groups.

Sensitizing brain metastases to stereotactic radiosurgery using hyperbaric oxygen: A proof-of-principle study.

PURPOSE: Increased oxygen levels may enhance the radiosensitivity of brain metastases treated with stereotactic radiosurgery (SRS). This project administered hyperbaric oxygen (HBO) prior to SRS to assess feasibility, safety, and response. METHODS: 38 patients were studied, 19 with 25 brain metastases treated with HBO prior to SRS, and 19 historical controls with 27 metastases, matched for histology, GPA, resection status, and lesion size. Outcomes included time from HBO to SRS, quality-of-life (QOL) measures, local control, distant (brain) metastases, radionecrosis, and overall survival. RESULTS: The average time from HBO chamber to SRS beam-on was 8.3 ± 1.7 minutes. Solicited adverse events (AEs) were comparable between HBO and control patients; no grade III or IV serious AEs were observed. Radionecrosis-free survival (RNFS), radionecrosis-free survival before whole-brain radiation therapy (WBRT) (RNBWFS), local recurrence-free survival before WBRT (LRBWFS), distant recurrence-free survival before WBRT (DRBWFS), and overall survival (OS) were not significantly different for HBO patients and controls on Kaplan-Meier analysis, though at 1-year estimated survival rates trended in favor of SRS + HBO: RNFS - 83% vs 60%; RNBWFS - 78% vs 60%; LRBWFS - 95% vs 78%; DRBWFS - 61% vs 57%; and OS - 73% vs 56%. Multivariate Cox models indicated no significant association between HBO treatment and hazards of RN, local or distant recurrence, or mortality; however, these did show statistically significant associations (p < 0.05) for: local recurrence with higher volume, radionecrosis with tumor resection, overall survival with resection, and overall survival with higher GPA. CONCLUSION: Addition of HBO to SRS for brain metastases is feasible without evident decrement in radiation necrosis and other clinical outcomes.

Immediate Symptom Relief After a First Session of Massage Therapy or Reiki in Hospitalized Patients: A 5-Year Clinical Experience from a Rural Academic Medical Center.

OBJECTIVES: There is an increasing demand for and use of alternative and complementary therapies, such as reiki and massage therapy, in hospital-based settings. Most controlled studies and practice-based reports include oncology and surgical patient populations; thus the effect in a more heterogeneous hospitalized patient population is hard to estimate. We examined the immediate symptom relief from a single reiki or massage session in a hospitalized population at a rural academic medical center. DESIGN: Retrospective analysis of prospectively collected data on demographic, clinical, process, and quality of life for hospitalized patients receiving massage therapy or reiki. SETTINGS/LOCATION: A 396-bed rural academic and tertiary medical center in the United States. SUBJECTS: Hospitalized patients requesting or referred to the healing arts team who received either a massage or reiki session and completed both a pre- and post-therapy symptom questionnaire. INTERVENTIONS: First session of routine reiki or massage therapy during a hospital stay. OUTCOME MEASURES: Differences between pre- and postsession patient-reported scores in pain, nausea, fatigue, anxiety, depression, and overall well-being using an 11-point Likert scale. RESULTS: Patients reported symptom relief with both reiki and massage therapy. Analysis of the reported data showed reiki improved fatigue (-2.06 vs. -1.55 p < 0.0001) and anxiety (-2.21 vs. -1.84 p < 0.001) statistically more than massage. Pain, nausea, depression, and well being changes were not statistically different between reiki and massage encounters. Immediate symptom relief was similar for cancer and noncancer patients for both reiki and massage therapy and did not vary based on age, gender, length of session, and baseline symptoms. CONCLUSIONS: Reiki and massage clinically provide similar improvements in pain, nausea, fatigue, anxiety, depression, and overall well-being while reiki improved fatigue and anxiety more than massage therapy in a heterogeneous hospitalized patient population. Controlled trials should be considered to validate the data.

Computer-assisted behavioral therapy and contingency management for cannabis use disorder.

Computer-assisted behavioral treatments hold promise for enhancing access to and reducing costs of treatments for substance use disorders. This study assessed the efficacy of a computer-assisted version of an efficacious, multicomponent treatment for cannabis use disorders (CUD), that is, motivational enhancement therapy, cognitive-behavioral therapy, and abstinence-based contingency-management (MET/CBT/CM). An initial cost comparison was also performed. Seventy-five adult participants, 59% Black, seeking treatment for CUD received either, MET only (BRIEF), therapist-delivered MET/CBT/CM (THERAPIST), or computer-delivered MET/CBT/CM (COMPUTER). During treatment, the THERAPIST and COMPUTER conditions engendered longer durations of continuous cannabis abstinence than BRIEF (p < .05), but did not differ from each other. Abstinence rates and reduction in days of use over time were maintained in COMPUTER at least as well as in THERAPIST. COMPUTER averaged approximately $130 (p < .05) less per case than THERAPIST in therapist costs, which offset most of the costs of CM. Results add to promising findings that illustrate potential for computer-assisted delivery methods to enhance access to evidence-based care, reduce costs, and possibly improve outcomes. The observed maintenance effects and the cost findings require replication in larger clinical trials.

Multidimensional needs of caregivers for patients with cancer.

This pilot study describes the multidimensional (physical, psychological, social, and spiritual) needs of caregivers of cancer survivors. A regional comprehensive cancer center and nine community-based rural and urban cancer clinics in New Hampshire assembled a convenience sample. Patients with cancer completed an online survey, the cancer survivor Web-based needs assessment survey (CS-WEBS), to identify needs and desire for intervention. Patients then identified a caregiver who was recruited to complete a caregiver version of the CS-WEBS. Caregivers reported challenges within all four domains of the survivorship model. The highest reported physical symptoms were fatigue, insomnia, and weight gain. Social symptoms included financial issues. Although visiting nurse services were the most commonly used resource, many caregivers used no supportive services. The most common caregiver task was listening and talking. Caregivers frequently experienced fatigue, anxiety, and insomnia. Exploring effective ways to alleviate their symptom burden should be a priority. Local and national attention should be directed toward easing the financial burden of caring for a patient with cancer.

Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial.

CONTEXT: There are few randomized controlled trials on the effectiveness of palliative care interventions to improve the care of patients with advanced cancer. OBJECTIVE: To determine the effect of a nursing-led intervention on quality of life, symptom intensity, mood, and resource use in patients with advanced cancer. DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial conducted from November 2003 through May 2008 of 322 patients with advanced cancer in a rural, National Cancer Institute-designated comprehensive cancer center in New Hampshire and affiliated outreach clinics and a VA medical center in Vermont. INTERVENTIONS: A multicomponent, psychoeducational intervention (Project ENABLE [Educate, Nurture, Advise, Before Life Ends]) conducted by advanced practice nurses consisting of 4 weekly educational sessions and monthly follow-up sessions until death or study completion (n = 161) vs usual care (n = 161). MAIN OUTCOME MEASURES: Quality of life was measured by the Functional Assessment of Chronic Illness Therapy for Palliative Care (score range, 0-184). Symptom intensity was measured by the Edmonton Symptom Assessment Scale (score range, 0-900). Mood was measured by the Center for Epidemiological Studies Depression Scale (range, 0-60). These measures were assessed at baseline, 1 month, and every 3 months until death or study completion. Intensity of service was measured as the number of days in the hospital and in the intensive care unit (ICU) and the number of emergency department visits recorded in the electronic medical record. RESULTS: A total of 322 participants with cancer of the gastrointestinal tract (41%; 67 in the usual care group vs 66 in the intervention group), lung (36%; 58 vs 59), genitourinary tract (12%; 20 vs 19), and breast (10%; 16 vs 17) were randomized. The estimated treatment effects (intervention minus usual care) for all participants were a mean (SE) of 4.6 (2) for quality of life (P = .02), -27.8 (15) for symptom intensity (P = .06), and -1.8 (0.81) for depressed mood (P = .02). The estimated treatment effects in participants who died during the study were a mean (SE) of 8.6 (3.6) for quality of life (P = .02), -24.2 (20.5) for symptom intensity (P = .24), and -2.7 (1.2) for depressed mood (P = .03). Intensity of service did not differ between the 2 groups. CONCLUSION: Compared with participants receiving usual oncology care, those receiving a nurse-led, palliative care-focused intervention addressing physical, psychosocial, and care coordination provided concurrently with oncology care had higher scores for quality of life and mood, but did not have improvements in symptom intensity scores or reduced days in the hospital or ICU or emergency department visits. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00253383.

The project ENABLE II randomized controlled trial to improve palliative care for rural patients with advanced cancer: baseline findings, methodological challenges, and solutions.

OBJECTIVE: There is a paucity of randomized controlled trials (RCTs) to evaluate models of palliative care. Although interventions vary, all have faced a variety of methodological challenges including adequate recruitment, missing data, and contamination of the control group. We describe the ENABLE II intervention, methods, and sample baseline characteristics to increase intervention and methodological transparency, and to describe our solutions to selected methodological issues. METHODS: Half of the participants recruited from our rural U.S. comprehensive cancer center and affiliated clinics were randomly assigned to a phone-based, nurse-led educational, care coordination palliative care intervention model. Intervention services were provided to half of the participants weekly for the first month and then monthly until death, including bereavement follow-up call to the caregiver. The other half of the participants were assigned to care as usual. Symptoms, quality of life, mood, and functional status were assessed every 3 months until death. RESULTS: Baseline data of 279 participants were similar to normative samples. Solutions to methodological challenges of recruitment, missing data, and "usual care" control group contamination are described. SIGNIFICANCE OF RESULTS: It is feasible to overcome many of the methodological challenges to conducting a rigorous palliative care RCT.

Endogenous formation of N'-nitrosonornicotine in F344 rats in the presence of some antioxidants and grape seed extract.

N'-Nitrosonornicotine (NNN) is one of the most abundant strong carcinogens in unburned tobacco and cigarette smoke and is classified by the International Agency for Research on Cancer as carcinogenic to humans. Human exposure to NNN mainly occurs upon use of tobacco products. It is also possible that additional amounts of NNN are formed endogenously. The goal of this study was to evaluate the inhibitory effect of some antioxidants, including ascorbic acid and grape seed extract (GSE), on endogenous NNN formation in rats treated with nornicotine and sodium nitrite by gavage twice daily for 3 days. The study included four groups of rats: (1) negative control group A, to which no chemical was administered; (2) negative control group B, treated with nornicotine alone (2.5 micromol per gavage); (3) positive control group, to which both nornicotine (2.5 micromol per gavage) and sodium nitrite (7.5 micromol per gavage) were administered; and (4) rats treated with nornicotine (2.5 micromol per gavage), inhibitor (7.5 or 37.5 micromol per gavage), and sodium nitrite (7.5 micromol per gavage). The mean (+/-SD) total amount of NNN in the 3-day urine of rats treated with both nornicotine and sodium nitrite was 4.78 +/- 2.88 nmol. The order of inhibition of endogenous NNN formation in rats at the molar ratio [nitrite]:[inhibitor] 1:5 was as follows: ascorbic acid (91%) > dihydroxyfumaric acid (86%) approximately catechin (85%) > resveratrol (no inhibition). Treatment of rats with grape seed extract did not produce statistically significant inhibition of endogenous nornicotine nitrosation. This is the first study that demonstrates endogenous NNN formation in rats treated with nornicotine and sodium nitrite and effective inhibition of this process by ascorbic acid, dixydroxyfumaric acid, and catechin.