Perceived shared decision-making among patients undergoing lower-limb amputation and their care teams: A qualitative study.

BACKGROUND: Shared decision-making (SDM) is increasingly advocated in the care of vascular surgery patients. The goal of this investigation was to gain a greater understanding of the patient and provider experience of SDM during clinical decision-making around the need for lower-extremity amputation and amputation level related to chronic limb-threatening ischemia (CLTI) in the Veterans Health Administration. METHODS: Semistructured interviews in male Veterans with CLTI, vascular surgeons, physical medicine and rehabilitation physicians, and podiatric surgeons. Interviews were analyzed using team-based content analysis to identify themes related to amputation-level decisions. RESULTS: We interviewed 22 patients and 21 surgeons and physicians and identified 4 themes related to SDM: (1) providers recognize the importance of incorporating patient preferences into amputation-level decisions and strive to do so; (2) patients do not perceive that they are included as equal partners in decisions around amputation or amputation level; (3) providers perceive several obstacles to including patients in amputation level decisions; and (4) patients describe facilitators to their involvement in SDM. CONCLUSIONS: Despite the recognized importance SDM in amputation decision-making, patients often perceived that their opinion was not solicited. This may result from provider perception of significant challenges to SDM posed by the clinical context of amputation. Patients identified key features that might enhance SDM including presentation of clear, concise information, and the importance of communicating concern during the discussion. These findings point to gaps in the provision of patient-centric care through SDM discussions at the time of amputation.

Role of prospective registries in defining the value and effectiveness of spine care.

STUDY DESIGN: Literature review and case example. OBJECTIVE: Describe methodological considerations of spine surgery registries. Review existing spine surgery registries. Describe the Vanderbilt Prospective Spine Registry (VPSR) as a case example and demonstrate its impact on comparative effectiveness research, value analysis, quality improvement, and practice-based learning. SUMMARY OF BACKGROUND DATA: To bend the cost curve and ultimately achieve sustainability in health care, medical providers and surgical treatments of the highest quality and effectiveness must be preferentially used and purchased. As the current US health care environment continues to evolve, it will be essential for all spine clinicians to understand and be facile with the principles of evidence-based health care reform. METHODS: We describe the methodological considerations of spine surgery registries, review the literature to describe existing spine surgery registries, and discuss the VPSR as a case example. RESULTS: We were able to obtain detailed information on 13 existing spine surgery registries through various internet-based resources. Of the 13, 2 registries had start dates before 2000, 3 between 2001 and 2005, 5 starting in 2006, and 3 were indeterminate. Follow-up rates were in the range from 22% to 79%, with longer follow-up times consistently producing lower follow-up rates. CONCLUSION: Prospective, longitudinal, patient-reported outcomes registries are powerful tools that allow measurement of cost, safety, effectiveness, and health care value across clinically meaningful episodes of care. Registries entirely based on claims or billing data, safety measures alone, process measures, or other proxies of outcome offer valuable insights, but do not provide comprehensive data to drive patient-centered value-based reform. As more spine-focused registries emerge and their integration into the US health care delivery evolve, the evidence to power value-based reform will be enabled.

Body mass index patterns following dysvascular lower extremity amputation.

PURPOSE: Using preliminary data, we examined: (i) patterns of body mass index (BMI) over the year following amputation by amputation level and (ii) the association between BMI and mobility and prosthetic device use. METHOD: Patients from three medical centers undergoing dysvascular amputation (N = 87; M age = 62) participated in interviews pre-surgically and at 6 weeks, 4 months, and 12 months following amputation. The main outcome was self-reported BMI, adjusting for limb weight lost due to amputation. Additional outcomes were mobility and time spent using and walking in a prosthetic device. RESULTS: Adjusted BMI slightly decreased at 6 weeks (pre-surgery M = 31.2; 6 weeks M = 30.3) and 4 months (M = 30.7) but exceeded baseline levels by 12 months (M = 31.7). There were no significant BMI differences by amputation level. In multivariable analyses, higher pre-surgical BMI was associated with fewer hours of prosthetic device walking at month 4 (ß = -0.49) and poorer overall mobility at month 12 (ß = -0.22). CONCLUSIONS: BMI increased at one year following amputation surgery. Higher pre-surgical BMI was associated with poorer mobility and prosthetic device use. Interventions are needed to prevent excess weight gain in the year following amputation. IMPLICATIONS FOR REHABILITATION: • People undergoing lower-extremity amputation have high rates of overweight and obesity and continue to gain weight in the year following amputation. • Objective assessment of body mass index (both with and without a prosthetic device) and waist circumference would help future research efforts. • Targeting weight loss post-amputation could improve the health of people with lower-extremity amputations.

Evaluation of clinical experience using cell-based therapies in patients with spinal cord injury: a systematic review.

OBJECT: Using a systematic approach, the authors evaluated the current utilization, safety, and effectiveness of cellular therapies for traumatic spinal cord injuries (SCIs) in humans. METHODS: A systematic search and critical review of the literature published through mid-January 2012 was performed. Articles included in the search were restricted to the English language, studies with at least 10 patients, and those analyzing cellular therapies for traumatic SCI. Citations were evaluated for relevance using a priori criteria, and those that met the inclusion criteria were critically reviewed. Each article was then designated a level of evidence that was developed by the Oxford Centre for Evidence-Based Medicine. RESULTS: The initial literature search identified 651 relevant articles, which decreased to 350 after excluding case reports and reviews. Evaluation of articles at the title/abstract level, and later at the full-text level, limited the final article set to 12 papers. The following cellular therapies employed in humans with SCI are reviewed: bone marrow mesenchymal and hematopoietic stem cells (8 studies), olfactory ensheathing cells (2 studies), Schwann cells (1 study), and fetal neurogenic tissue (1 study). Overall the quality of the literature was very low, with 3 Grade III levels of evidence and 9 Grade IV studies. CONCLUSIONS: Several different cellular-mediated strategies for adult SCI have been reported to be relatively safe with varying degrees of neurological recovery. However, the literature is of low quality and there is a need for improved preclinical studies and prospective, controlled clinical trials.

Chronic low back pain: a heterogeneous condition with challenges for an evidence-based approach.

"Chronic" low back pain (LBP), defined as present for 3 or more months, has become a major socioeconomic problem insufficiently addressed by five major entities largely working in isolation from one another - procedural based specialties, strength based rehabilitation, cognitive behavioral therapy, pain management and manipulative care. As direct and indirect costs continue to rise, many authors have systematically evaluated the body of evidence in an effort to demonstrate the effectiveness (or lack thereof) for various diagnostic and therapeutic interventions. The objective of this Spine Focus issue is not to replicate previous work in this area. Rather, our expert panel has chosen a set of potentially controversial topics for more in-depth study and discussion. A recurring theme is that chronic LBP is a heterogeneous condition, and this affects the way it is diagnosed, classified, treated, and studied. The efficacy of some treatments may be appreciated only through a better understanding of heterogeneity of treatment effects (i.e., identification of clinically relevant subgroups with differing responses to the same treatment). Current clinical guidelines and payer policies for LBP are systematically compared for consistency and quality. Novel approaches for data gathering, such as national spine registries, may offer a preferable approach to gain meaningful data and direct us towards a "results-based medicine." This approach would require more high-quality studies, more consistent recording for various phenotypes and exploration of studies on genetic epidemiologic undertones to guide us in the emerging era of "results based medicine."

Analgesia following surgery in children with and without cognitive impairment.

Both children and adults with cognitive impairment (CI) have historically been excluded from research examining pain. This is unfortunate since patients with CI may be at higher risk for experiencing pain or having their pain undertreated due to the difficulty of pain assessment and communication. There are now several published reports about the general pain experience of both adult and pediatric patients with cognitive impairment. The purpose of this study was to compare the amount and type of pain medication administered in children with and without CI after surgery to ascertain if there were any differences in analgesic administration patterns between these two groups. One hundred and fifty-two children with borderline to profound CI and 138 non impaired (NI) children were recruited to participate. Analgesic administration data include type and amount of opioid, type of non-opioid medication, and prescribed discharge medications. Results of this study show that children with CI undergoing surgery received less opioid in the perioperative period than children without CI. However, children with CI received comparable amounts and types of analgesics in the postoperative period as children without CI.