Gold standard research and evidence applied: The Inspire Nursing Leadership Program.

Billions of dollars are invested annually in leadership development globally; however, few programs are evidence-based, risking adverse outcomes, and wasted time and money. This article describes the novel Inspire Nursing Leadership Program (INLP) and the outcomes-based process of incorporating gold standard evidence into its design, delivery, and evaluation. The INLP design was informed by a needs analysis, research evidence, and by nursing, Indigenous, and equity, diversity, and inclusion experts. The program's goals include enabling participants to develop leadership capabilities, cultivate strategic community partnerships, lead innovation projects, and connect with colleagues. Design features include an outcomes-based approach, the LEADS framework, and alignment with the principles of adult learning. Components include leadership impact projects, 360-assessments, blended interactive sessions, coaching, mentoring, and application and reflection exercises. The evaluation framework and subsequent proposed research design align to top-quality standards. Healthcare leadership programs must be evidence-based to support leaders in improving and transforming health systems.

Current challenges in spinal cord stimulation.

OBJECTIVES: This study aims to review the current state of spinal cord stimulation for the treatment of chronic pain associated with failed back surgery syndrome (FBSS) and complex regional pain syndrome (CRPS) and to describe intraspinal targets and stimulation parameters, patient selection, therapy cost-effectiveness, and strategies to improve outcomes. MATERIALS AND METHODS: We drew on professional literature spanning four decades, our work with national and international professional societies, and our own extensive clinical experience to summarize contemporary knowledge of the safety, efficacy, cost-efficiency, and challenges associated with spinal cord stimulation in treating chronic pain. RESULTS: The safety, efficacy, and cost-efficiency of spinal cord stimulation in treating chronic pain associated with FBSS and CRPS are well established through randomized controlled trials and long-term observational studies. Challenges include reducing wait-times before implant, which are associated with lower success rates; increasing awareness of this therapy among referring physicians, patients, and payers; decreasing device-related complications by incorporating advanced technology, improved operative and trialing techniques, and appropriate patient selection; and capturing functional and quality-of-life outcomes. Spinal cord stimulation must be part of an overall treatment plan to manage chronic pain, and must engage physicians, patients, their families, pharmacists, nursing staff, and mental health experts in supporting a return to employment, if possible, and to a full domestic and social life. CONCLUSIONS: Innovation in spinal cord stimulation therapy has intensified with numerous new technical capabilities, safety advances, and novel stimulation targets. This progress holds hope for the many sufferers of chronic pain.

Impact of wait times on spinal cord stimulation therapy outcomes.

OBJECTIVE: Presently, the long-term success rate of spinal cord stimulation (SCS) ranges from 47% to 74%. SCS efficacy is inversely proportional to the passage of time between development of chronic pain syndrome and time of implantation. To improve outcomes, implantation should be performed early. This study identifies sources of delay and offers suggestions for improvement. METHODS: A retrospective analysis of 437 SCS patients examines delays to accessing SCS at various points in the referral stream, from initial diagnosis, family physician, and various specialist treatments, to implantation. Analysis of variance evaluated the effect of age, sex, treating specialty, and their interactions on implantation delay. A multiple linear regression model was developed to assess factors contributing to implantation delay. RESULTS: From time of onset of chronic pain to implantation, patients endured a delay of 65.4 ± 2.04 months. Initial physician contact occurred at a mean of 3.4 ± 0.12 months after development of pain syndrome. Family physicians managed cases for 11.9 ± 0.45 months and various specialists for an additional 39.8 ± 1.22 months. Neurosurgeons were quickest to refer to an implant physician (average wait-time 32.28 ± 2.64 months), while orthopedic surgeons and nonimplanting anesthesiologists took the longest, contributing to wait times of 51.60 ± 5.04 months and 58.08 ± 5.76 months, respectively. Once the decision for implantation was made, the implanting physician required 3.31 ± 0.09 months to organize the procedure. A gradual decline in wait times was observed from 1980 to present. CONCLUSION: To improve SCS success rates, physicians involved in the treatment for chronic pain should refer these cases early to an implant physician once failure of medical management becomes apparent.

Cost impact of intrathecal polyanalgesia.

OBJECTIVE: To assess the cost impact of dose escalation with intrathecal drug therapy and polyanalgesic admixtures and determine if increased cost is justified by improved pain control. METHODS: A retrospective analysis of 110 patients, 80 patients with chronic non-cancer pain (Group A) and 30 with spasticity (Group B). Mean follow-up period was 73 months (Group A) and 112 months (Group B). Parameters assessed were: demographics, drug usage, drug costs, and pain/spasticity control. Two models were developed: 1) price model--estimated drug price per refill; 2) cost model--predicts costs/day by therapy types and four common pathologies over 5 years. RESULTS: All patients started on monotherapy with 63 continuing (Group A: 39; Group B: 24), with 47 (Group A: 41; Group B: 6) requiring dual-drug therapy of which 11 (Group A: 10; Group B: 1) progressed to triple-drug admixtures. After starting polyanalgesic regimes, patients were able to recapture lost pain control. Cost escalation in Group A at 5 years, as demonstrated by cost modeling, was 191%, 107%, and 89% for mono-, dual-, or triple-drug therapy, respectively. For Group B, most patients stayed in monotherapy and the 5-year increase was 104%. The difference in cost between monotherapy and dual therapy for Group A was $1.97/day (baseline) to $3.28/day (5th year) and between dual and triple therapy from $2.55/day (baseline) to $4.30/day (5th year). CONCLUSIONS: Polyanalgesia, while more costly, is justified based on its effectiveness in restoring pain control. Superior results are achieved when polyanalgesia is initiated early. Cost modeling enabled price prediction for the purposes of developing program budgets.

Cost effectiveness of intrathecal drug therapy in management of chronic nonmalignant pain.

OBJECTIVE: To evaluate the cost effectiveness of intrathecal drug therapy (IDT) compared with conventional medical management (CMM) for patients with refractory chronic noncancer pain. METHODS: A probabilistic Markov model was developed to evaluate the cost effectiveness of IDT versus CMM from the perspective of a Canadian provincial Ministry of Health using data from our pain clinic. The model followed costs and outcomes in 6-month cycles. Health effects were expressed as quality-adjusted life years (QALYs) gained. Resources use included drugs, physician visits, laboratory tests, scans, and hospitalizations. Unit costs were gathered from public sources and were expressed in 2011 Canadian dollars. Costs and effects were evaluated over a time horizon of 10 years and discounted at 5% per annum after the first year. Cost effectiveness was identified by deterministic and probabilistic sensitivity analyses (50,000 Monte Carlo iterations). RESULTS: Over 10 years, total costs were $61,442 for IDT and $48,408 for CMM. Thus, the incremental effectiveness of IDT was 1.1508 QALYs at an incremental cost of $13,034, resulting in an incremental cost-effectiveness ratio of $11,326/QALY gained. The probability of IDT providing a cost-effective alternative to CMM was 50% and 84% at a willingness-to-pay threshold of $14,200 and $20,000/QALY, respectively. The results were most sensitive to the cost of CMM, the probability of reaching an optimal health state with dual-drug IDT, and the effectiveness of CMM therapy. Sensitivity analyses showed that results were robust to plausible variations in model costs and effectiveness inputs. DISCUSSION: IDT is cost effective compared with CMM in the management of chronic noncancer pain.

A comparative analysis of the results of vertebroplasty and kyphoplasty in osteoporotic vertebral compression fractures.

BACKGROUND: The most common complication of osteoporosis is vertebral fractures, which occur more frequently than all other fractures (hip, wrist, and ankle). OBJECTIVE: To prospectively analyze vertebroplasty compared with kyphoplasty for the treatment of osteoporotic vertebral compression fractures using improvement in pain, functional capacity, and quality of life as outcome measures. METHODS: The study population included 28 patients in the vertebroplasty group and 24 patients in the kyphoplasty group. The mean follow-up period was 42.2 weeks and 42.3 weeks in the vertebroplasty and kyphoplasty groups, respectively. Outcomes were measured pre- and postoperatively using the visual analogue scale, the Oswestry Disability Index, the EuroQol-5D questionnaire, and the Short-Form 36 Health Survey. RESULTS: In the vertebroplasty group, visual analogue scale scores improved from a mean of 8.0 cm to 5.5 cm at last follow-up (P = .001). Preoperatively, the Oswestry Disability Index was 57.6, which improved to 38.4 (P = .006). The EuroQol-5D score preoperatively was 0.157 and improved to 0.504 (P = .001). The Short-Form 36 Health Survey showed greatest improvement in the areas of physical health, role physical, body pain, and vitality. In the kyphoplasty group, visual analogue scale scores improved from a mean of 7.5 cm preoperatively to 2.5 cm postoperatively (P = .000001). The mean Oswestry Disability Index preoperatively was 50.7 and improved to 28.8 (P = .002). The EuroQol-5D score improved from a mean of 0.234 preoperatively to 0.749 (P = .00004). The Short-Form 36 Health Survey showed greatest improvement in the areas of physical health, physical functioning, role physical, body pain, and social functioning. CONCLUSION: Both vertebroplasty and kyphoplasty are effective at improving pain, functional disability, and quality of life; however, kyphoplasty provides better results, which are maintained over long-term follow-up.

Use of intrathecal bupivacaine in refractory chronic nonmalignant pain.

OBJECTIVE: To demonstrate the efficacy and safety of the addition of bupivacaine in restoring pain control and improving quality of life and activity level in patients with chronic nonmalignant pain refractory to intrathecal opioids. DESIGN: Retrospective study. SETTING: Outpatient clinics. PATIENTS: Seventeen patients with inadequate pain relief while receiving intrathecal opioids alone. Interventions. The intrathecal opioid dose was held constant at 14.19 mg/day following the addition of bupivacaine. The initial bupivacaine dose was 2.08 mg/day and 4.83 mg/day at final follow up. OUTCOME MEASURES: Pain relief, activity, depression, and quality of life were measured by the Visual Analog Scale (VAS), Oswestry Disability Index (ODI), Beck Depression Inventory (BDI), EuroQol 5D (EQ-5D), and Short Form 36 (SF-36), respectively. Reduction in oral medication use, return to employment, and device-related complications were also analyzed. Outcomes were evaluated prior to pump implantation, before the addition of bupivacaine (baseline), and every 6 months thereafter. RESULTS: Seventeen patients were followed for 29.60 +/- 19.01 months. The average pain reduction measured by the VAS was 32.2%. The ODI improved 19.1%; BDI improved 17.9%; EQ-5D improved by 0.56; and the SF-36 showed statistical improvement in six of eight domains. Mean oral/transdermal opioid use reduced from 49.01 mg/day to 23.02 mg/day and oral non-opioid medications reduced from 2.2 classes to 1.0 class after the addition of bupivacaine. Two additional patients returned to work. No neurological sequelae resulted from adding bupivacaine. CONCLUSIONS: The addition of intrathecal bupivacaine restores pain control, improves activity level, quality of life, and mental health in this patient group.

Financial impact of spinal cord stimulation on the healthcare budget: a comparative analysis of costs in Canada and the United States.

OBJECT: Many institutions with spinal cord stimulation (SCS) programs fail to realize that besides the initial implantation cost, budgetary allocation must be made to address annual maintenance costs as well as complications as they arise. Complications remain the major contributing factor to the overall expense of SCS. The authors present a formula that, when applied, provides a realistic representation of the actual costs necessary to implant and maintain SCS systems in Canada and the US. METHODS: The authors performed a retrospective analysis of 197 cases involving SCS (161 implanted and 36 failed trial stimulations) between 1995 and 2006. The cost of patient workup, initial implantation, annual maintenance, and resources necessary to resolve complications were assessed for each case and a unit cost applied. The total cost allocated for each case was determined by summing across healthcare resource headings. Using the same parameters, the unit cost was calculated in both Canadian (CAD) and US dollars (USD) at 2007 prices. RESULTS: The cost of implanting a SCS system in Canada is $21,595 (CAD), in US Medicare $32,882 (USD), and in US Blue Cross Blue Shield (BCBS) $57,896 (USD). The annual maintenance cost of an uncomplicated case in Canada is $3539 (CAD), in US Medicare $5071 (USD), and in BCBS $7277 (USD). The mean cost of a complication was $5191 in Canada (range $136-18,837 [CAD]). In comparison, in the US the figures were $9649 (range $381-28,495) for Medicare and $21,390 (range $573-54,547) for BCBS (both USD). Using these calculations a formula was derived as follows: the annual maintenance cost (a) was added to the average annual cost per complication per patient implanted (b); the sum was then divided by the implantation cost (c); and the result was multiplied by 100 to obtain a percentage (a + b / c x 100). To make this budgetary cap universally applicable, the results from the application of the formula were averaged, resulting in an 18% premium. CONCLUSIONS: For budgeting purposes the institution should first calculate the initial implantation costs that then can be "grossed up" by 18% per annum. This amount of 18% should be in addition to the implantation costs for the individual institution for new patients, as well as for each actively managed patient. This resulting amount will cover the costs associated with annual maintenance and complications for every actively managed patient. As the initial cost of implantation in any country reflects their current economics, the formula provided will be applicable to all implanters and policy makers alike.