Prosthesis preferences for those with upper limb loss: Discrete choice study of PULLTY® for use in regulatory decisions.

Introduction: The patient's voice in shared decision-making has progressed from physician's office to regulatory decision-making for medical devices with FDA's Patient Preference Initiative. A discrete-choice preference measure for upper limb prosthetic devices was developed to investigate patient's risk/benefit preference choices for regulatory decision making. Methods: Rapid ethnographic procedures were used to design a discrete-choice measure describing risk and benefits of osseointegration with myoelectric control and test in a pilot preference study in adults with upper limb loss. Primary outcome is utility of each choice based conjoint (CBC) attribute using mixed-effects regression. Utilities with and without video, and between genders were compared. Results: Strongest negative preference was for avoiding infection risk (B = -1.77, p < 0.001) and chance of daily pain (B = -1.22, p, 0.001). Strongest positive preference was for attaining complete independence when cooking dinner (B = 1.62, p < 0.001) and smooth grip patterns at all levels (B = 1.62, B = 1.28, B = 1.26, p < 0.001). Trade-offs showed a 1% increase in risk of serious/treatable infection resulted in a 1.77 decrease in relative preference. There were gender differences, and where video was used, preferences were stronger. Conclusions: Strongest preferences were for attributes of functionality and independence versus connectedness and sensation but showed willingness to make risk-benefit trade-offs. Findings provide valuable information for regulatory benefit-risk decisions for prosthetic device innovations. Trial Registration: This study is not a clinical trial reporting results of a health care intervention so is not registered.

Preliminary Study of Virtual-reality-guided Meditation for Veterans with Stress and Chronic Pain.

Context: Studies have found evidence for meditation's positive effects on health and well-being, but the difficulty of learning and engaging in meditation practice has been identified as a major barrier. Virtual reality (VR) technology may facilitate meditation practice by immersing users in a distraction-free and calming virtual environment, although this theory has yet to be rigorously tested. Objective: This study intended to examine the efficacy of VR-guided meditation in a population of US veterans as a tool to facilitate meditation and relaxation practice for reduction of stress and chronic pain as well as to elicit participants' feedback regarding their perceptions of VR-guided meditation. Design: The research team designed a preliminary study to identify the scope of future investigations. Setting: The study was conducted at an outpatient polytrauma clinic in a Veterans Affairs (VA) Palo Alto Health Care System, located in Palo Alto, California. Participants: Participants were a convenience sample of 31 veterans, with an average age of 55.2 years, who were patients at the polytrauma clinic and who had conditions with varying levels of stress and chronic pain. Intervention: All participants completed a 10-minute, VR-guided-meditation session based on the Zen form of meditation. Outcome Measures: At baseline immediately before and postintervention immediately after the VR meditation session, self-report ratings of pain and stress, physiological measures testing heart rate (HR) and blood pressure (BP), and participants' survey responses that assessed their experiences with, attitudes toward, and concerns about VR for clinical therapy were obtained. Results: Participants showed statistically significant reductions in self-reported pain and stress, HR, and systolic and diastolic BP. Participants reported high satisfaction with VR-guided meditation, and few reported negative side-effects. Conclusions: The study provided evidence for the usefulness of VR technology as a facilitator of meditation practice for reduction of stress and chronic pain. Future studies are needed to examine the long-term effects of repeated VR-guided-meditation sessions for patients with stress and chronic pain.

Headache Diary Mobile Application for Monitoring and Characterizing Posttraumatic Headaches.

OBJECTIVE: This study analyzed the data collected using a headache diary mobile application to characterize posttraumatic headaches (PTHs) in a sample of US veterans. Specifically, we measured patient engagement with the mobile application and compared our findings with previous literature regarding PTHs. SETTING: A Headache Center of Excellence (HCoE) in a Veterans Health Administration facility. PARTICIPANTS: Forty-nine veterans currently being treated for ongoing PTH-related complaints with English fluency, reliable access to the internet, and a mobile phone. DESIGN: Observational study of PTH characteristics using the mobile application over the course of 1 year. MEASURES: Main outcome measures were collected via a headache diary mobile application developed for patients to track headache-associated symptoms, headache location, triggers, type, intensity, and duration. Patients also completed a baseline Headache Impact Test (HIT-6) survey. RESULTS: In total, 1569 entries were completed during the first year of application deployment. On average, patients completed 2.5 entries per week and used the application for 70 days. They frequently reported associated PTH symptoms of photophobia (56.7%) and headaches triggered by emotional stress (35.1%). Network analyses revealed patterns of co-occurrence in triggers of headache pain, associated symptoms, and headache pain location. Headache pain severity and impact ratings from the headache diary demonstrated convergent validity with the established HIT-6 measure. CONCLUSIONS: Headache diary mobile applications are a promising tool for monitoring and characterizing PTHs in veterans. Present results mirror past studies of PTH characteristics. Mobile application headache diaries may be used in both clinical and research settings to monitor headache symptoms and communicate the functional impact of headaches in real time.

Venous Thromboembolism is Associated With Lack of Vitamin D Supplementation in Patients With Spinal Cord Injury and Low Vitamin D Levels.

BACKGROUND: The role of vitamin D in the pathogenesis of venous thromboembolism (VTE) and prevalence of low vitamin D (LVitD) in spinal cord injury (SCI) has motivated vitamin D testing and supplementation. This is an exploratory study of data collected at a time before the routine clinical practice of vitamin D supplementation, allowing for evaluation of the natural history of vitamin D levels in patients with SCI. OBJECTIVE: To determine if vitamin D supplementation in persons with SCI and LVitD levels is associated with decreased prevalence of VTE. DESIGN: Retrospective cohort study. SETTING: Rehabilitation Center at a Level I Trauma Center. PARTICIPANTS: Patients with SCI admitted to acute inpatient rehabilitation (N = 282). MAIN OUTCOME MEASURES: VTE prevalence in patients with LVitD levels, grouped by presence or absence of vitamin D supplementation. RESULTS: Of the acute inpatient SCI population, 80% (227/282) of patients demonstrated vitamin D levels <30 ng/mL (LVitD). Although the incidence of VTE was almost double in the LVitD group, 19% (43/227) of the patients in the LVitD group had VTE versus 9% (5/55) of patients with vitamin D levels ≥30 ng/mL (normal VitD [NVitD]); this difference was not statistically significant (P = .108, Cramer's V = .104). When the role of vitamin D supplementation was analyzed, individuals in the LVitD group who received no vitamin D supplementation (LVitDSuppNegative) had a higher incidence of VTE (statistically significant) compared to the LVitD group with vitamin D supplementation (LVitDSuppPositive) (24% [42/178] vs. 2% [1/49]) (P < .001, Cramer's V = .226). In post hoc exploratory analyses, the VTE rate of patients in the LVitDSuppNegative group was noted to be significantly higher than that in all other patient groups combined (P < .001, Cramer's V = .229). A binary logistic regression model incorporating clinical covariates also showed this grouping to be significant. CONCLUSION: A significant association appears to exist between lack of vitamin D supplementation and VTE occurrence in persons with acute SCI and LVitD levels. LEVEL OF EVIDENCE: III.

Health Coaching: A Preliminary Report on the Effects in Traumatic Brain Injury/Polytrauma Patients.

BACKGROUND: Failure to adhere to treatment recommendations has significant impact on the health outcomes of the individual and health care systems. Health coaching is a promising care model that has gained interest in the medical field. This study focused on the impact of health coaching on health behaviors that may have direct impact on successful patient outcomes. PRIMARY STUDY OBJECTIVE: The objective of this study was to assess the impact of health coaching administered through the Polytrauma Integrative Medicine Initiative (PIMI). METHODS/DESIGN: This study was a quasiexperimental cohort study. SETTING: This study occurred at a specialized polytrauma rehabilitation center. PARTICIPANTS: Participants were divided into 3 cohorts: (1) 33 patients who served through PIMI enrollment, (2) 22 patients who declined PIMI, and (3) a control cohort of 30 random patients who were not referred to PIMI. Patients were primarily male active duty or veteran military personnel. INTERVENTION: The intervention consisted of personalized health coaching by trained, certified personnel. PRIMARY OUTCOME MEASURES: Outcome measures included the following (1) Self-assessment: utilizing the Personal Health Inventory (PHI) at enrollment and at 3 mo; (2) treatment adherence: the percentage of scheduled appointments fulfilled by patients; and (3) post hoc analysis: for no-show and cancellation rates; 2-tailed paired t tests for PHI data and post hoc within groups; 2-tailed independent samples t tests for treatment adherence percentages and post hoc between groups. RESULTS: There was no significant difference in treatment adherence rates between the 3 cohorts (all P > .45). PIMI patients had significantly higher cancellation rates than no-show rates for both clinical, 20.8%/5%, and coaching appointments, 17.3%/7.5%, (P < .05). PIMI patients had significantly lower no-show rates, 5%, than control patients, 15.8% (P = .007). PHI data suggest PIMI patients believe they are making improvements in many areas of health coaching focus. CONCLUSION: Low cohort numbers are a concern. There was no difference for treatment adherence rates for health coaching compared with no health coaching. Select variables such as cancellation and no-show appointment rates may better capture the impact of health coaching on patient behavior and clinical resource utilization.

Low-dose outpatient chemobiotherapy with temozolomide, granulocyte-macrophage colony stimulating factor, interferon-alpha2b, and recombinant interleukin-2 for the treatment of metastatic melanoma.

PURPOSE: The objective of this study was to further investigate the efficacy and safety of low-dose outpatient chemobiotherapy in patients with unresectable metastatic melanoma. PATIENTS AND METHODS: Thirty-one patients with histologically confirmed unresectable measurable metastatic melanoma were enrolled onto an open-label, multicenter phase II study. The treatment regimen consisted of oral temozolomide followed by subcutaneous biotherapy with granulocyte macrophage colony-stimulating factor, interferon-alfa, and recombinant interleukin-2 (rIL-2). RESULTS: Twenty-eight patients (90%) had M1c disease, and 58% had three or more sites of metastasis. Four patients (13%), all with M1c disease, had a complete response, and four patients had a partial response. The median progression-free survival was 4.9 months and the median overall survival was 13.1 months. Two patients (6%) developed CNS metastasis as the first site of disease progression, and 7 (23%) of 30 experienced CNS progression after receiving chemobiotherapy. A total of 112 cycles of therapy were administered. Toxicity occurred in 78% of the cycles and was grade 1 or 2 in the majority of cases and easily managed. Grade 4 toxicity occurred in 3% of the cycles. CONCLUSION: This low-dose chemobiotherapy combination produces clinical responses in patients with metastatic melanoma, even in those with M1c disease, is well tolerated, and allows home dosing. It offers a reasonable alternative to high-dose regimens, such as high-dose biochemotherapy or rIL-2 requiring prolonged periods of hospitalization, or single agent outpatient regimens, such as dacarbazine, which is usually not effective in patients with M1c disease. Furthermore, it may protect against the development of brain metastases.