Urethral outcomes in metoidioplasty and phalloplasty gender affirming surgery (MaPGAS) and vaginectomy: a systematic review.

Background: There is currently a paucity of data on urethral-related outcomes in metoidioplasty and phalloplasty gender affirming surgery (MaPGAS) with urethral lengthening (UL)and vaginectomy. Methods: A systematic review was performed utilizing MEDLINE, Web of Science, Cochrane Library, Europe PMC, OSF Preprints, and EMBASE. Methodologic quality was scored using Methodological Index for Non-Randomized Studies (MINORS) criteria. Four independent reviewers performed the article evaluation, data extraction, and methodologic quality assessment. Primary outcomes included standing to urinate/pee (STP), penile length, glanular meatus, urethral stricture, fistula, and flap necrosis. Results were summarized qualitatively with descriptive statistics. Results: A total of 2,881 articles of which 11 retrospective reviews of 13 cohorts met criteria; 4.3/16 average (avg) MINORS score. Six metoidioplasty cohorts had an average penile length of 6 cm, 74% reported successful STP, and a quarter developed stricture or fistula. Phalloplasty cohorts included radial forearm flap (RF) and Anterolateral Thigh flap (ALT). Of the 4 RF studies nearly a third developed a stricture or fistula and only one study reported 99% STP with a glanular meatus. Three ALT studies reported no length but had 80-90% STP with a glanular meatus and a quarter with stricture or fistula. Conclusions: Urethral complications in MaPGAS-UL in a cohort with prior vaginectomy are common and variably reported. Patient centered outcome measures as well as clearly defined outcome metrics created in partnership with community members are needed.

Patterns of Opioid Use in the 12 Months Following Geriatric Fragility Fractures: A Population-Based Cohort Study.

OBJECTIVES: Fractures of the hip, distal radius, and proximal humerus are common in the Medicare population. This study's objective was to characterize patterns and duration of opioid use, including regional variations in use, after both surgical and nonoperative management. DESIGN: Population-based cohort study. SETTING AND PARTICIPANTS: A cohort of opioid-naïve community-dwelling US Medicare beneficiaries who survived a hip, distal radius, or proximal humerus fracture between January 1, 2007 and December 31, 2010. Cohort members were required to be opioid-naïve for 4 months prior to fracture. MEASURES: We analyzed the proportion of patients with an active opioid prescription in each month following the index fracture, and report continued fills at 12 months postfracture. We also compared opioid prescription use in fractures treated surgically and nonsurgically and characterized state-level variation in opioid prescription use at 3 months postfracture. RESULTS: There were 91,749 patients included in the cohort. Hip fracture patients had the highest rate of opioid use at 12 months (6.4%), followed by proximal humerus (5.7%), and distal radius (3.7%). Patients who underwent surgical fixation of proximal humerus and wrist fractures had higher rates of opioid use in each of the first 12 postoperative months compared with those managed nonoperatively. There was significant variation of opioid use at the state level, ranging from 7.6% to 18.2% of fracture patients filling opioid prescriptions 3 months after the index fracture. CONCLUSIONS/IMPLICATIONS: Opioid-naïve patients sustaining fragility fractures of the hip, proximal humerus, or distal radius are at risk to remain on opioid medications 12 months after their index injury, and surgical management of proximal humerus and distal radius fractures increases opioid use in the 12 months after the index fracture. There is significant state-level variation in opiate consumption after index fracture in nonvertebral geriatric fragility fractures. Opportunity exists for targeted quality improvement efforts to reduce the variation in opioid use following common geriatric fragility fractures.

Long-Term Results of Surgery Compared With Nonoperative Treatment for Lumbar Degenerative Spondylolisthesis in the Spine Patient Outcomes Research Trial (SPORT).

STUDY DESIGN: Randomized trial with a concurrent observational cohort study. OBJECTIVE: To compare 8-year outcomes between surgery and nonoperative care and among different fusion techniques for symptomatic lumbar degenerative spondylolisthesis (DS). SUMMARY OF BACKGROUND DATA: Surgical treatment of DS has been shown to be more effective than nonoperative treatment out to 4 years. This study sought to further determine the long-term (8-year) outcomes. METHODS: Surgical candidates with DS from 13 centers with at least 12 weeks of symptoms and confirmatory imaging were offered enrollment in a randomized controlled trial (RCT) or observational cohort study (OBS). Treatment consisted of standard decompressive laminectomy (with or without fusion) versus standard nonoperative care. Primary outcome measures were the Short Form-36 (SF-36) bodily pain and physical function scores and the modified Oswestry Disability Index at 6 weeks, 3 months, 6 months, and yearly up to 8 years. RESULTS: Data were obtained for 69% of the randomized cohort and 57% of the observational cohort at the 8-year follow up. Intent-to-treat analyses of the randomized group were limited by high levels of nonadherence to the randomized treatment. As-treated analyses in the randomized and observational groups showed significantly greater improvement in the surgery group on all primary outcome measures at all time points through 8 years. Outcomes were similar among patients treated with uninstrumented posterolateral fusion, instrumented posterolateral fusion, and 360° fusion. CONCLUSION: For patients with symptomatic DS, patients who received surgery had significantly greater improvements in pain and function compared with nonoperative treatment through 8 years of follow-up. Fusion technique did not affect outcomes. LEVEL OF EVIDENCE: 1.

A Person-Centered, Registry-Based Learning Health System for Palliative Care: A Path to Coproducing Better Outcomes, Experience, Value, and Science.

BACKGROUND: Palliative care offers an approach to the care of people with serious illness that focuses on quality of life and aligning care with individual and family goals, and values in the context of what is medically achievable. OBJECTIVE: Measurement of the impact of palliative care is critical for determining what works for which patients in what settings, to learn, improve care, and ensure access to high value care for people with serious illness. METHODS: A learning health system that includes patients and families partnering with clinicians and care teams, is directly linked to a registry to support networks for improvement and research, and offers an ideal framework for measuring what matters to a range of stakeholders interested in improving care for this population. MEASUREMENTS: Measurement focuses on the individual patient and family experience as the fundamental outcome of interest around which all care delivery is organized. RESULTS: We describe an approach to codesigning and implementing a palliative care registry that functions as a learning health system, by combining patient and family inputs and clinical data to support person-centered care, quality improvement, accountability, transparency, and scientific research. DISCUSSION: The potential for a palliative care learning health system that, by design, brings together enriched information environments to support coproduction of healthcare and facilitated peer networks to support patients and families, collaborative clinician networks to support palliative care program improvement, and collaboratories to support research and the application of research to benefit individual patients is immense.

Local emergency medical response after a terrorist attack in Norway: a qualitative study.

INTRODUCTION: On 22 July 2011, Norway suffered a devastating terrorist attack targeting a political youth camp on a remote island. Within a few hours, 35 injured terrorist victims were admitted to the local Ringerike community hospital. All victims survived. The local emergency medical service (EMS), despite limited resources, was evaluated by three external bodies as successful in handling this crisis. This study investigates the determinants for the success of that EMS as a model for quality improvement in healthcare. METHODS: We performed focus group interviews using the critical incident technique with 30 healthcare professionals involved in the care of the attack victims to establish determinants of the EMS' success. Two independent teams of professional experts classified and validated the identified determinants. RESULTS: Our findings suggest a combination of four elements essential for the success of the EMS: (1) major emergency preparedness and competence based on continuous planning, training and learning; (2) crisis management based on knowledge, trust and data collection; (3) empowerment through multiprofessional networks; and (4) the ability to improvise based on acquired structure and competence. The informants reported the successful response was specifically based on multiprofessional trauma education, team training, and prehospital and in-hospital networking including mental healthcare. The powerful combination of preparedness, competence and crisis management built on empowerment enabled the healthcare workers to trust themselves and each other to make professional decisions and creative improvisations in an unpredictable situation. CONCLUSION: The determinants for success derived from this qualitative study (preparedness, management, networking, ability to improvise) may be universally applicable to understanding the conditions for resilient and safe healthcare services, and of general interest for quality improvement in healthcare.

Risk Factors for Reoperation in Patients Treated Surgically for Degenerative Spondylolisthesis: A Subanalysis of the 8-year Data From the SPORT Trial.

STUDY DESIGN: Retrospective analysis of prospective data from the degenerative spondylolisthesis (DS) arm of the Spine Patient Outcomes Research Trial. OBJECTIVE: The aim of this study was to identify risk factors for reoperation in patients treated surgically for DS and compare outcomes between patients who underwent reoperation with nonreoperative patients. SUMMARY OF BACKGROUND DATA: Several studies have examined outcomes following surgery for DS, but few have identified risk factors for reoperation. METHODS: Analysis included patients with neurogenic claudication (>12 weeks), clinical neurological signs, spinal stenosis, and DS on standing lateral x-rays. Univariate and multivariate analyses were used to investigate patient characteristics and risk factors. Treatment effects (TEs) were calculated and compared between study groups. RESULTS: Of 406 patients, 72% underwent instrumented fusion, 21% noninstrumented fusion, and 7% decompression alone. At 8 years, the reoperation rate was 22%, of which 28% occurred within 1 year, 54% within 2 years, 70% within 4 years, and 86% within 6 years. The reasons for reoperation included recurrent stenosis or progressive spondylolisthesis (45%), complications such as hematoma, dehiscence, or infection (36%), or new condition (14%). Reoperative patients were younger (62.2 vs. 65.3, P = 0.008). Significant risk factors were use of antidepressants (P = 0.008, hazard ratio [HR] 2.08) or having no neurogenic claudication upon enrollment (P = 0.02, HR 1.82). Patients who were smokers, diabetics, obese, or on workman's compensation were not at greater risk for reoperation. At 8-year follow-up, scores for SF-36 bodily pain (BP), Oswestry Disability Index, American Academy of Orthopaedic Surgeons/Modems version (ODI), and stenosis frequency index were better in nonreoperative patients. TE favored nonreoperative patients for SF-36 BP, physical function, ODI, Stenosis Bothersomeness Index, and satisfaction with symptoms (P < 0.001). CONCLUSION: The incidence of reoperation for patients with DS was 22% 8 years following surgery. Patients with a history of no neurogenic claudication and patients taking antidepressants were more likely to undergo reoperation. Outcome scores and TE were more favorable in nonreoperative patients. LEVEL OF EVIDENCE: 2.

Evidence on the Validity of a Comprehensive Health Risk Index and Implications for Ambulatory Care and Population Health Management.

A novel, comprehensive health risk index for adults has been validated and is now ready for use to improve the health of individuals and populations. This health risk index provides an estimate of the avoidable risk of death for adults 30 years or older. It includes 12 evidence-based clinical and behavioral risk factors and was validated on discrimination and calibration using the NHANES (National Health and Nutrition Examination Survey) and Framingham Heart Study cohorts. The results from both cohorts were consistent and similar. Discrimination was good, and calibration was acceptable but tended to overpredict mortality risk for females in the higher-risk deciles.

Pain Recurrence After Discectomy for Symptomatic Lumbar Disc Herniation.

STUDY DESIGN: Secondary analysis of data from a concurrent randomized trial and cohort study. OBJECTIVE: The aim of this study was to determine risks and predictors of recurrent pain following standard open discectomy for subacute/chronic symptomatic lumbar disc herniation (SLDH). SUMMARY OF BACKGROUND DATA: Most previous studies of recurrence after discectomy do not explicitly define pain resolution and recurrence, and do not account for variable durations of time at risk for recurrence. METHODS: We used survival analysis methods to examine predictors of leg pain recurrence. For individuals with initial resolution of leg pain, we defined recurrent leg pain as having leg pain, receiving lumbar epidural steroid injections, or undergoing lumbar surgery subsequent to initial leg pain resolution. We calculated cumulative risks of leg pain recurrence using Kaplan-Meier survival curves, and examined predictors of recurrence using Cox proportional hazards models. We used similar methods to examine LBP recurrence. RESULTS: One- and three-year cumulative risks of leg pain recurrence were 20% and 45%, respectively. One- and three- year leg pain recurrence risks were substantially lower in participants with complete initial resolution of leg pain (17% and 41%, respectively) than in those without (27% and 54%, respectively). In multivariate analyses, complete leg pain resolution (adjusted hazard ratio [aHR] 0.69; 95% confidence interval [CI] 0.52-0.90), smoking (aHR 1.68 [95% CI 1.22-2.33]), and depression (aHR 1.74 [95% CI 1.18-2.56]) predicted leg pain recurrence. The 1- and 3-year risk of LBP recurrence was 29% and 65%, respectively. LBP recurrence risk at 3 years was substantially lower in participants with complete initial resolution of LBP than in those without, but not at 1 year. CONCLUSION: Recurrence of leg pain and LBP is common after discectomy for SLDH. Cumulative risks of both leg pain and LBP recurrence were generally lower in participants achieving complete initial resolution of pain post-discectomy. LEVEL OF EVIDENCE: 2.

Recurrence of Pain After Usual Nonoperative Care for Symptomatic Lumbar Disk Herniation: Analysis of Data From the Spine Patient Outcomes Research Trial.

OBJECTIVE: To determine risks and predictors of recurrent leg and low back pain (LBP) after unstructured, usual nonoperative care for subacute/chronic symptomatic lumbar disk herniation (LDH). DESIGN: Secondary analysis of data from a concurrent randomized trial and observational cohort study. SETTING: Thirteen outpatient spine practices. PARTICIPANTS: A total of 199 participants with resolution of leg pain and 142 participants with resolution of LBP from among 478 participants receiving usual nonoperative care for symptomatic LDH. ASSESSMENT OF RISK FACTORS: Potential predictors of recurrence included time to initial symptom resolution, sociodemographics, clinical characteristics, work-related factors, imaging-detected herniation characteristics, and baseline pain bothersomeness. MAIN OUTCOME MEASUREMENTS: Leg pain and LBP bothersomeness were assessed by the use of a 0-6 numerical scale at up to 4 years of follow-up. For individuals with initial resolution of leg pain, we defined recurrent leg pain as having leg pain, receiving lumbar epidural steroid injections, or undergoing lumbar surgery subsequent to initial leg pain resolution. We calculated cumulative risks of recurrence by using Kaplan-Meier survival plots and examined predictors of recurrence using Cox proportional hazards models. We used similar definitions for LBP recurrence. RESULTS: One- and 3-year cumulative recurrence risks were 23% and 51% for leg pain, and 28% and 70% for LBP, respectively. Early leg pain resolution did not predict future leg pain recurrence. Complete leg pain resolution (adjusted hazard ratio [aHR] 0.47, 95% confidence interval [CI] 0.31-0.72) and posterolateral herniation location (aHR 0.61; 95% CI 0.39-0.97) predicted a lower risk of leg pain recurrence, and joint problems (aHR 1.89; 95% CI 1.16-3.05) and smoking (aHR 1.81; 95% CI 1.07-3.05) predicted a greater risk of leg pain recurrence. For participants with complete initial resolution of pain, recurrence risks at 1 and 3 years were 16% and 41% for leg pain and 24% and 59% for LBP, respectively. CONCLUSIONS: Recurrence of pain is common after unstructured, usual nonsurgical care for LDH. These risk estimates depend on the specific definitions applied, and the predictors identified require replication in future studies.

Risk Factors for Reoperation in Patients Treated Surgically for Intervertebral Disc Herniation: A Subanalysis of Eight-Year SPORT Data.

BACKGROUND: Lumbar discectomy and laminectomy in patients with intervertebral disc herniation (IDH) is common, with variable reported reoperation rates. Our study examined which baseline characteristics might be risk factors for reoperation and compared outcomes between patients who underwent reoperation and those who did not. METHODS: We performed a retrospective subgroup analysis of patients from the IDH arm of the Spine Patient Outcomes Research Trial (SPORT) randomized and observational cohorts. We analyzed baseline characteristics and outcomes of patients who underwent reoperation and those who did not with use of data collected from enrollment through eight-years of follow-up after surgery. Follow-up times were measured from the time of surgery, and baseline covariates were updated to the follow-up immediately preceding the time of surgery for outcomes analyses. RESULTS: At eight years, the reoperation rate was 15% (691 no reoperation; 119 reoperation). Sixty-two percent of these patients underwent reoperation because of a recurrent disc herniation; 25%, because of a complication or other factor; and 11%, because of a new condition. The proportion of reoperations that were performed for a recurrent disc herniation ranged from 58% to 62% in the individual years. Older patients were less likely to have reoperation (p = 0.015), as were patients presenting with asymmetric motor weakness at baseline (p = 0.0003). Smoking, diabetes, obesity, Workers' Compensation, and clinical depression were not associated with a greater risk of reoperation. Scores on the Short Form (SF)-36 for bodily pain and physical functioning, the Oswestry Disability Index (ODI), and the Sciatica Bothersomeness Index as well as satisfaction with symptoms had improved less at the time of follow-up in the reoperation group (p < 0.001). CONCLUSIONS: In patients who underwent surgery for IDH, the overall reoperation rate was 15% at the eight-year follow-up. Patients of older age and patients presenting with asymmetric motor weakness were less likely to undergo a reoperation. Less improvement in patient-reported outcomes was noted in the reoperation group.

Long-term outcomes of lumbar spinal stenosis: eight-year results of the Spine Patient Outcomes Research Trial (SPORT).

STUDY DESIGN: Randomized trial with a concurrent observational cohort study. OBJECTIVE: To compare 8-year outcomes of surgery with nonoperative care for symptomatic lumbar spinal stenosis. SUMMARY OF BACKGROUND DATA: Surgery for spinal stenosis has been shown to be more effective than nonoperative treatment during 4 years, but longer-term data are less clear. METHODS: Surgical candidates from 13 centers in 11 US states with at least 12 weeks of symptoms and confirmatory imaging were enrolled in a randomized cohort or observational cohort. Treatment was standard, decompressive laminectomy versus standard nonoperative care. Primary outcomes were SF-36 (MOS 36-Item Short-Form Health Survey) Bodily Pain and Physical Function scales and the modified Oswestry Disability Index assessed at 6 weeks, 3 months, 6 months, and yearly up to 8 years. RESULTS: Data were obtained for 55% of participants in the randomized group and 52% of participants in the observational group at the 8-year follow-up. Intent-to-treat analyses showed no differences between randomized cohorts; however, 70% of those randomized to surgery and 52% of those randomized to nonoperative had undergone surgery by 8 years. As-treated analyses in the randomized group showed that the early benefit for surgery out to 4 years converged over time, with no significant treatment effect of surgery seen in years 6 to 8 for any of the primary outcomes. In contrast, the observational group showed a stable advantage for surgery in all outcomes between years 5 and 8. Patients who were lost to follow-up were older, less well-educated, sicker, and had worse outcomes during the first 2 years in both surgical and nonoperative arms. CONCLUSION: Patients with symptomatic spinal stenosis show diminishing benefits of surgery in as-treated analyses of the randomized group between 4 and 8 years, whereas outcomes in the observational group remained stable. Loss to follow-up of patients with worse early outcomes in both treatment groups could lead to overestimates of long-term outcomes but likely not bias treatment effect estimates.

The SPORT value compass: do the extra costs of undergoing spine surgery produce better health benefits?

BACKGROUND: The Spine Patient Outcomes Research Trial aimed to determine the comparative effectiveness of surgical care versus nonoperative care by measuring longitudinal values: outcomes, satisfaction, and costs. METHODS: This paper aims to summarize available evidence from the Spine Patient Outcomes Research Trial by addressing 2 important questions about outcomes and costs for 3 types of spine problem: (1) how do outcomes and costs of spine patients differ depending on whether they are treated surgically compared with nonoperative care? (2) What is the incremental cost per quality adjusted life year for surgical care over nonoperative care? RESULTS: After 4 years of follow-up, patients with 3 spine conditions that may be treated surgically or nonoperatively have systematic differences in value endpoints. The average surgical patient enjoys better health outcomes and higher treatment satisfaction but incurs higher costs. CONCLUSIONS: Spine care is preference sensitive and because outcomes, satisfaction, and costs vary over time and between patients, data on value can help patients make better-informed decisions and help payers know what their dollars are buying.

Early Patient Outcomes After Primary Total Knee Arthroplasty with Quadriceps-Sparing Subvastus and Medial Parapatellar Techniques: A Randomized, Double-Blind Clinical Trial.

BACKGROUND: Techniques that reduce injury to the knee extensor mechanism may cause less pain and allow faster recovery of knee function after primary total knee arthroplasty. A quadriceps-sparing (QS) subvastus technique of total knee arthroplasty was compared with medial parapatellar arthrotomy (MPPA) to determine which surgical technique led to better patient-reported function and less postoperative pain and opioid utilization. METHODS: In this prospective, double-blind study, 129 patients undergoing total knee arthroplasty were randomized to the QS or the MPPA group after skin incision. All surgical procedures utilized minimally invasive surgery principles and standardized anesthesia, implants, analgesia, and rehabilitation. The Knee Society Score (KSS) was obtained at baseline and one and three months after surgery. Weekly telephone interviews were used to collect patient-reported outcomes including ambulatory device use, the UCLA (University of California Los Angeles) activity score, performance of daily living activities, and opioid utilization. RESULTS: No differences between groups were seen in opioid utilization, either during the acute hospitalization or in the eight weeks after surgery. The QS group reported significantly less pain at rest on postoperative day one and with activity on day three (p = 0.04 for each). Compared with baseline, both groups showed significant improvements in the KSS at one month (MPPA, p = 0.0278; QS, p = 0.0021) and three months (p < 0.0001 for each) as well as week-to-week gains in walking independence through five weeks after surgery. Independence from ambulatory devices outside the home lagged behind independence indoors by about two weeks in both groups. CONCLUSIONS: When primary total knee arthroplasty was performed with contemporary minimally invasive surgery principles and standardized implants, anesthesia, and postoperative pathways, the QS technique yielded no significant early functional advantages or differences in opioid utilization compared with the MPPA technique. However, the mean pain scores reported by patients in the QS group were slightly lower at rest on postoperative day one and during activity on day three. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Surgical versus nonoperative treatment for lumbar disc herniation: eight-year results for the spine patient outcomes research trial.

STUDY DESIGN: Concurrent prospective randomized and observational cohort studies. OBJECTIVE: To assess the 8-year outcomes of surgery versus nonoperative care. SUMMARY OF BACKGROUND DATA: Although randomized trials have demonstrated small short-term differences in favor of surgery, long-term outcomes comparing surgical with nonoperative treatment remain controversial. METHODS: Surgical candidates with imaging-confirmed lumbar intervertebral disc herniation meeting Spine Patient Outcomes Research Trial eligibility criteria enrolled into prospective randomized (501 participants) and observational cohorts (743 participants) at 13 spine clinics in 11 US states. Interventions were standard open discectomy versus usual nonoperative care. Main outcome measures were changes from baseline in the SF-36 Bodily Pain and Physical Function scales and the modified Oswestry Disability Index-AAOS/Modems version assessed at 6 weeks, 3 months, and 6 months, and annually thereafter. RESULTS: Advantages were seen for surgery in intent-to-treat analyses for the randomized cohort for all primary and secondary outcomes other than work status; however, with extensive nonadherence to treatment assignment (49% patients assigned to nonoperative therapy receiving surgery versus 60% of patients assigned to surgery) these observed effects were relatively small and not statistically significant for primary outcomes (bodily pain, physical function, Oswestry Disability Index). Importantly, the overall comparison of secondary outcomes was significantly greater with surgery in the intent-to-treat analysis (sciatica bothersomeness [P > 0.005], satisfaction with symptoms [P > 0.013], and self-rated improvement [P > 0.013]) in long-term follow-up. An as-treated analysis showed significant surgical treatment effects for primary outcome measures (mean change, surgery vs. nonoperative care; treatment effect; 95% confidence interval): bodily pain (45.3 vs. 34.4; 10.9; 7.7 to 14); PF (42.2 vs. 31.5; 10.6; 7.7 to 13.5); and Oswestry Disability Index (-36.2 vs. -24.8; -11.3; -13.6 to -9.1). CONCLUSION: Carefully selected patients who underwent surgery for a lumbar disc herniation achieved greater improvement than nonoperatively treated patients; there was little to no degradation of outcomes in either group (operative and nonoperative) from 4 to 8 years. LEVEL OF EVIDENCE: 2.

Pros and cons of pragmatic clinical trials.

Traditional randomized controlled trials are the 'gold standard' for evaluating health interventions and are typically designed to maximize internal validity, often at the cost of limited generalizability. Pragmatic randomized controlled trials should be designed with a conscious effort to generate evidence with a greater external validity by making the research question as similar as possible to the questions faced by clinical decision-makers (i.e., patients and their families, physicians, policy makers and administrators) and then answer that question with rigor. Clarity and transparency about the specifics of the research question are the keys to designing, as well as interpreting, any clinical trial.

Lumbar disc herniation in the Spine Patient Outcomes Research Trial: does educational attainment impact outcome?

STUDY DESIGN: Randomized trial with concurrent observational cohort. A total of 1171 patients were divided into subgroups by educational attainment: high school or less, some college, and college degree or above. OBJECTIVE: To assess the influence of education level on outcomes for treatment of lumbar disc herniation. SUMMARY OF BACKGROUND DATA: Educational attainment has been demonstrated to have an inverse relationship with pain perception, comorbidities, and mortality. METHODS: The Spine Patient Outcomes Research Trial enrolled surgical candidates (imaging-confirmed disc herniation with at least 6 weeks of persistent signs and symptoms of radiculopathy) from 13 multidisciplinary spine clinics in 11 US states. Treatments were standard open discectomy versus nonoperative treatment. Outcomes were changes from baseline for 36-Item Short Form Health Survey (SF-36), bodily pain (BP), and physical function (PF) scales and the modified Oswestry Disability Index (ODI) at 6 weeks, 3 months, 6 months, and yearly through 4 years. RESULTS: Substantial improvement was seen in all patient cohorts. Surgical outcomes did not differ by level of education. For nonoperative outcomes, however, higher levels of education were associated with significantly greater overall improvement over 4 years in BP (P = 0.007), PF (P = 0.001), and ODI (P = 0.003). At 4 years a "dose-response" type relationship was shown for BP (high school or less = 25.5, some college = 31, and college graduate or above = 36.3, P = 0.004) and results were similar for PF and ODI. The success of nonoperative treatment in the more educated cohort resulted in an attenuation of the relative benefit of surgery. CONCLUSION: Patients with higher educational attainment demonstrated significantly greater improvement with nonoperative treatment while educational attainment was not associated with surgical outcomes.

The impact of diabetes on the outcomes of surgical and nonsurgical treatment of patients in the spine patient outcomes research trial.

STUDY DESIGN: A secondary analysis comparing diabetic patients with nondiabetic patients enrolled in the Spine Patient Outcomes Research Trial (SPORT). OBJECTIVE: To compare surgical outcomes and complications between diabetic and nondiabetic spine patients. SUMMARY OF BACKGROUND DATA: Patients with diabetes are predisposed to comorbidities that may confound the diagnosis and treatment of patients with spinal disorders. METHODS: Baseline characteristics and outcomes of 199 patients with diabetes were compared with those of the nondiabetic population in a total of 2405 patients enrolled in the Spine Patient Outcomes Research Trial for the diagnoses of intervertebral disc herniation (IDH), spinal stenosis (SpS), and degenerative spondylolisthesis (DS). Primary outcome measures include the 36-Item Short Form Health Survey (SF-36) Health Status questionnaire and the Oswestry Disability Index. RESULTS: Patients with diabetes were significantly older and had a higher body mass index than nondiabetic patients. Comorbidities, including hypertension, stroke, cardiovascular disease, and joint disease, were significantly more frequent in diabetic patients than in nondiabetic patients. Patients with diabetes and IDH did not make significant gains in pain and function with surgical intervention relative to diabetic patients who underwent nonoperative treatment. Diabetic patients with SpS and DS experienced significantly greater improvements in pain and function with surgical intervention when compared with nonoperative treatment. Among those who had surgery, nondiabetic patients with SpS achieved marginally significantly greater gains in function than their diabetic counterparts (SF-36 physical function, P = 0.062). Among patients who had surgery for DS, diabetic patients did not have as much improvement in pain or function as did the nondiabetic population (SF-36 bodily pain, P = 0.003; physical function, P = 0.002). Postoperative complications were more prevalent in patients with diabetes than in nondiabetic patients with SpS (P = 0.002). There was an increase in postoperative (P = 0.028) and intraoperative (P = 0.029) blood replacement in DS patients with diabetes. CONCLUSION: Diabetic patients with SpS and DS benefited from surgery, though older SpS patients with diabetes have more postoperative complications. IDH patients with diabetes did not benefit from surgical intervention.

Informed patient choice: patient-centered valuing of surgical risks and benefits.

The risks and benefits of any health care intervention are valued differently by stakeholders. One of the ethical imperatives of patient-centered care is the balanced, evidence-based presentation of risks and benefits by providers to patients. Using the example of musculoskeletal surgery with devices, we advocate the use of shared decision-making tools and processes known to improve knowledge, adjust unrealistic expectations, and elicit values about benefits desired and the degree of acceptable risks for individual patients. We describe feasibility and efficacy within our organization and address ways to foster the further adoption of this approach.