Prospective, multicenter study to evaluate performance and safety of a re-engineered temporary lead for InterStim™ therapy evaluation.

AIMS: The basic evaluation or percutaneous nerve evaluation (PNE) is a method to assess pre-implantation therapeutic response in patients considering sacral neuromodulation for the treatment of refractory overactive bladder. A new PNE lead with a more robust design and greater distensibility designed to reduce the possibility of lead migration has recently been introduced to the market. The aim of this prospective, multicenter, global, postmarket study was to evaluate the clinical performance and safety of the new InterStim PNE lead with the foramen needle. METHODS: Patients with overactive bladder were enrolled in this study. The primary objective of this study was to determine the proportion of subjects who demonstrated motor or sensory response(s) during lead placement using the InterStim PNE lead. Additional measures included the Patient Global Impression of Improvement (PGI-I), patient satisfaction at the end of therapy evaluation, and change in bladder symptoms from baseline to the end of therapy evaluation (1-week follow-up visit). RESULTS: One-hundred and ten subjects met the inclusion and exclusion criteria and underwent a lead implant procedure. Of those, 108 had a successful procedure and 107 completed the 1-week follow-up visit. Ninety-nine percent of subjects (109/110) had a motor or sensory response during needle placement (95% confidence interval [CI]: 95%-100%) and 97% of subjects (107/110) had a motor or sensory response during lead placement (95% CI: 92%-99%). The majority of subjects (88%, 95/108) reported their bladder condition was better at the follow-up visit compared to before the PNE implant procedure, as reported in PGI-I. Subjects reported being satisfied with how the therapy impacted their voiding symptoms (82%, 88/108) and that they would recommend this therapy (87%, 94/108) to other patients. Symptom improvement was demonstrated with urinary urge incontinence subjects having an average of 4.2 ± 3.4 urinary incontinence episodes/day at baseline and 2.2 ± 2.5 at follow-up, and urinary frequency subjects having an average of 12.5 ± 4.4 voids/day at baseline and 10.5 ± 4.3 voids/day at follow-up. Lead removal was deemed to be easy and safe by the implanting physician, with a total of three adverse device effects in 3/110 subjects. No event was categorized as serious and all were resolved without sequelae. CONCLUSIONS: The updated InterStim PNE lead with a more robust design and greater distensibility designed to reduce migration was shown to have a high rate of motor or sensory response during lead placement. Furthermore, subjects reported high rates of global improvements and amelioration of symptoms, and the lead was easy to remove with minimal morbidity.

Analysis of Morbidity and Mortality Outcomes in Postoperative Clostridium difficile Infection in the Veterans Health Administration.

IMPORTANCE: This study analyzes and reports Clostridium difficile infection (CDI) rates, risk factors, and associations with postoperative outcomes in the Veterans Health Administration (VHA). OBJECTIVE: To report 30-day postoperative CDI rates and outcomes and identify associated risks by surgical procedures and preoperative patient demographics in a large integrated health care system. DESIGN, SETTING, AND PARTICIPANTS: In a retrospective observational study conducted from September 2014 to April 2015, the Veterans Affairs Surgical Quality Improvement Program database and the Decision Support System pharmacy database were linked to analyze the association of postoperative CDI with patients' demographics, preoperative comorbidities, operative characteristics, and preoperative medications. The Veterans Affairs Surgical Quality Improvement Program assessments from October 1, 2009, to September 30, 2013, were investigated. The study was conducted at 134 VHA surgery programs, and the study population represents 12 surgical specialties: general, gynecological, neurosurgical, oral, orthopedics, otolaryngologic, plastic, podiatric, thoracic, transplant, urologic, and peripheral vascular. MAIN OUTCOMES AND MEASURES: Thirty-day postoperative CDI rates, risk factors of CDI, and association of CDI with postoperative morbidity and mortality. RESULTS: Among 468,386 surgical procedures, the postoperative CDI rate was 0.4% per year and varied by the VHA Surgery Program (0.0% to 1.4%) and surgical specialty (0.0% to 2.4%). Thirty-day CDI rates were higher in emergency procedures, procedures with greater complexity and higher relative value units, and those with a contaminated/infected wound classification. Patients with postoperative CDI were significantly older, more frequently hospitalized after surgery (59.9% vs 15.4%), had longer preoperative hospital stays (9.1 days vs 1.9 days), and had received 3 or more classes of antibiotics (1.5% vs 0.3% for a single antibiotic class) (all P < .001). Patients with CDI had higher rates of other postoperative morbidity (86.0% vs 7.1%), 30-day mortality (5.3% vs 1.0%), and longer postoperative hospital stays (17.9 days vs 3.6 days). Independent risk factors for CDI included commonly identified patient factors (albumin, functional class, and weight loss), procedural characteristics (complexity, relative value units, emergency, and wound classification), surgical program complexity, the number of preoperative antibiotic classes, and length of preoperative hospital stay. CONCLUSIONS AND RELEVANCE: The number and class of antibiotics administered after surgery, preoperative length of stay, procedural characteristics, surgical program complexity, and patient comorbidities are associated with postoperative CDI in the VHA.

Interventions to support a palliative care approach in patients with chronic obstructive pulmonary disease: an integrative review.

BACKGROUND: End-stage chronic obstructive pulmonary disease (COPD) is a debilitating, life-limiting condition. A palliative approach is appropriate for individuals with end-stage COPD, yet currently few interventions embrace this holistic, multidisciplinary and inclusive perspective. OBJECTIVE: To describe interventions to support a palliative care approach in patients with end-stage COPD. DESIGN: Integrative review. DATA SOURCES AND REVIEW METHOD: Peer reviewed articles meeting the search criteria were accessed from Medline, PsychINFO, CINAHL and Google Scholar databases as well as Caresearch online resource. The domains of quality palliative care developed by Steinhauser were used as the conceptual framework to synthesise information. RESULTS: This review has shown that a range of palliative interventions are used to address the needs of individuals with end-stage COPD. Although evidence exists for discrete elements of palliative management in this patient group, there is limited evidence for health service coordination and models that integrate the multiple domains of palliative care with active management. CONCLUSION: Further investigation is required to address the complex personal, provider and system elements associated with managing end-stage COPD. A comprehensive and collaborative approach is required to address the complex and varied needs of individuals with end-stage COPD and their families.

Developing spiritual and religious care competencies in practice: pilot of a Marie Curie blended learning event.

The Marie Curie Cancer Care (2003) Spiritual and Religious Care Competencies for Specialist Palliative Care provide a common language for healthcare practitioners in the nebulous area of spiritual care. The development of a pilot blended learning event, as described in this paper, sought to integrate the competencies into practice by providing opportunities both online and in the classroom to explore this aspect of holistic care in depth. In the planning stages, multiprofessional focus groups determined the level of delivery, and emerging themes shaped the content. Self-awareness and reflection were key features and part of the overall process to improve competency. The features of the virtual learning environment (VLE) used were video, facilitated asynchronous discussion and direct links to key articles and documents, while interactive classroom activities built on prior learning. Evaluation covered all aspects of the course design from participant and facilitator perspectives. Participant comments were overwhelmingly positive in relation to the content and chosen delivery methods with concerns about online learning proving unfounded.

Effects of Brassica vegetable juice on the induction of apoptosis and aberrant crypt foci in rat colonic mucosal crypts in vivo.

Glucosinolates are sulfur-containing glycosides found in the Brassica vegetables. Their breakdown products include isothiocyanates, which are produced following exposure to the endogenous plant enzyme myrosinase. Isothiocyanates are pungent, biologically active compounds that suppress carcinogenesis in vivo, and induce apoptosis in vitro. We have shown previously that oral administration of the isolated glucosinolate sinigrin induces apoptosis, and suppresses aberrant crypt foci in the colonic mucosa of rats treated previously with 1,2-dimethylhydrazine (DMH). In this study we explored the effects of both raw and thermally processed Brussels sprout tissue on the modulation of crypt cell apoptosis and mitosis, and the frequency of aberrant crypt foci in the colon. Freeze-dried raw and microwave-cooked Brussels sprouts contained high levels of intact glucosinolates, but they were absent from freshly prepared sprout juice. Oral administration of uncooked Brussels sprouts, whether as a juice, or as a freeze-dried powder, was associated with significantly enhanced levels of apoptosis and reduced mitosis in the colonic crypts. However, this effect was confined to rats previously injected (48 h) with DMH, in which levels of apoptosis and mitosis following DNA damage were already high. There was no effect of treatment in control animals. There was also little evidence of these effects when intact glucosinolates were administered in blanched sprout tissue, which lacked active myrosinase. We conclude that glucosinolate breakdown products derived from Brassica vegetables can exert a profound effect on the balance of colorectal cell proliferation and death in an animal model of colorectal neoplasia.