Objective Outcome Data Research Articles

Capsule Commentary on Lafata et al., Medication Adherence Does Not Explain Black-White Differences in Cardiometabolic Risk Factor Control among Insured Patients with Diabetes.

T he study by Lafata et al. evaluated whether medication adherence mediated racial disparities in achieving HBA1c, LDL or SBP targets among diabetics. The authors found that blacks had poorer medication adherence compared to whites in all three classes of medications, and were less likely to achieve clinical targets. Racial disparities persisted in multivariable models that included medication adherence and treatment intensification. The strengths of the study are the inclusion of patients from multiple sites and the use of objective adherence and outcome data. A limitation was the use of an adherence definition that required having at least two prescriptions filled, since the exclusion of subjects with no or one refill could have introduced bias. Other investigators have reported persistent disparities in cardiovascular outcomes between black and white subjects after adjusting for variables such as adherence, income, education, or burden of disease. This study highlights the complexity of the factors influencing disparities in health outcomes, which are diverse and dynamic and include a range of environmental exposures that shape beliefs, behaviors and interactions with the health system. The authors appropriately advocate the systematic evaluation of multiple types of barriers among subjects not reaching quality targets. This is important, since improvements in quality of care have not eliminated disparities. Chin et al. concluded that reducing disparities requires six key steps which include making equity a priority of quality improvement efforts and designing interventions based on the local root causes. The patient-centered model of care may facilitate this individualized approach and should be a focus of future research. In the meantime, we must be careful in how we interpret the evidence. Factors such as medication adherence, depression, health literacy, or income play a role, though don’t completely explain differences in clinical outcomes among minorities. This should not diminish efforts to recognize or target them. In this study, the percentage of black subjects achieving targets was higher among adherent subjects. We should continue to search for factors that more fully explain disparities, but also develop strategies to improve known mediators of outcomes, among those medication adherence. Equity must be a priority.

Sports participation and radiographic findings of adolescents treated nonoperatively for displaced clavicle fractures

BackgroundThere is a relative paucity of high-level evidence that guides the treatment of displaced midshaft clavicle fractures in adolescents. Some use overhead sports or significant shortening as relative indications for surgical treatment, while others rarely consider operative intervention for these patients. The purpose of this study is to determine the effect of overhead sports participation and fracture shortening on subjective and objective outcomes after nonoperative treatment of displaced midshaft clavicle fractures in those aged 10–17 years. MethodsUsing a radiographic database, adolescents with displaced clavicle fractures were identified and contacted over the phone. These subjects were invited to take part in the study in return for compensation. Radiographic measurements of dedicated clavicle films around the time of injury were performed, and a custom survey aimed at elucidating participation in overhead or contact sports was given. The Nottingham Clavicle Score (NCS) and the Constant Shoulder Score were obtained for each patient to provide both subjective and objective outcome data. Statistical Package for Social Science (SPSS) software (version 22, IBM) was used to compare radiographic and sports data to the outcome measures. ResultsGender, age at the time of fracture, time since fracture, relative and absolute radiographic shortening, and hand dominance were all not significantly correlated with subjective or objective outcomes. Five patients (23%) reported not feeling happy with the appearance of their shoulder at the beach or at the pool. This group had statistically lower NCS results. Eleven of 22 participated in ≥6 months per year of overhead or contact sports; they did not have worse subjective or objective outcomes. ConclusionsFracture shortening and sports participation do not have a significant impact in adolescents on outcomes after displaced midshaft clavicle fracture.

PD50-08 PREDICTORS OF REGRET AFTER COLPOCLEISIS FOR PELVIC ORGAN PROLAPSE: A SYSTEMATIC REVIEW

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Pelvic Prolapse1 Apr 2015PD50-08 PREDICTORS OF REGRET AFTER COLPOCLEISIS FOR PELVIC ORGAN PROLAPSE: A SYSTEMATIC REVIEW Juzar Jamnagerwalla, Karyn Eilber, Samantha Jagannathan, Niv Hakami-Majd, Eugene Shkolyar, and Jennifer Anger Juzar JamnagerwallaJuzar Jamnagerwalla More articles by this author , Karyn EilberKaryn Eilber More articles by this author , Samantha JagannathanSamantha Jagannathan More articles by this author , Niv Hakami-MajdNiv Hakami-Majd More articles by this author , Eugene ShkolyarEugene Shkolyar More articles by this author , and Jennifer AngerJennifer Anger More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.2016AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Colpocleisis is a safe and effective procedure to alleviate the symptoms of pelvic organ prolapse (POP) in women who are not sexually active (Fitzgerald et al). With the goal of determining factors associated with regret after colpocleisis, we synthesized the available literature examining satisfaction and reasons for regret among women undergoing colpocleisis. METHODS The review was conducted according to the recommendations of the MOOSE (Meta-Analysis of Observational Studies in Epidemiology) group. We performed a systematic review of PubMed and Medline to identify articles published between 1948 and 2013 using search terms “colpocleisis, obliterative and vaginal”. RESULTS Our literature search identified 182 titles, of which 42 were ultimately included in the review. Twenty-nine studies reported objective POP outcomes data with a pooled patient population of 1,714 patients. Objective POP success ranged from 89% to 100%. Seventeen studies included satisfaction in their analysis, with a pooled patient population of 1,077 patients. The individual satisfaction reported in these studies ranged from 86.4% to 96%. Twenty-four studies included data on urinary outcomes after colpocleisis. The rate of de novo stress urinary incontinence (SUI) in women who did not undergo concomitant sling ranged from 0-13%. In women who had preoperative SUI with concurrent placement of midurethral sling, SUI was persistent in between 6-17% of women. Ten studies included regret in their analysis, with a pooled patient population of 415 patients. Thirty-one out of 415 women (7.5%) at least partially regretted their decision. Frequent causes of regret included loss of sexual function (41%) and worsening pre-operative urinary incontinence (31%). CONCLUSIONS Though colpocleisis is associated with a high success and satisfaction rate overall, few studies exist that examine sources of regret. The data available suggests that regret is often due to worsening urinary incontinence or remorse about loss of sexual function. Careful patient selection for colpocleisis may help predict who may be more likely to become sexually active again. In addition, patient age alone should not deter providers from placing a concomitant prophylactic sling at the time of colpocleisis. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e1048 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Juzar Jamnagerwalla More articles by this author Karyn Eilber More articles by this author Samantha Jagannathan More articles by this author Niv Hakami-Majd More articles by this author Eugene Shkolyar More articles by this author Jennifer Anger More articles by this author Expand All Advertisement Advertisement PDF DownloadLoading ...

The Lymphedema Evaluation in Gynecological cancer Study (LEGS): design of a prospective, longitudinal, cohort study

Background: The Lymphoedema Evaluation in Gynecological cancer Study (LEGS) was a longitudinal, observational, cohort study prospectively evaluating the incidence and risk factors of lower-limb lymphedema after treatment for gynecological cancer. Here we describe the study protocol and characteristics of the sample. Methods: Women with a newly diagnosed gynecological cancer between June 1, 2008 and February 28, 2011, aged 18 years or older, and treated at one of six hospitals in Queensland, Australia, were eligible. Lymphedema was assessed by circumference measurements, bioimpedance spectroscopy, and self-reported swelling. LEGS incorporated a cohort of patients requiring surgery for benign gynecological conditions for comparison purposes. Data were collected prior to surgery and at regular intervals thereafter up to 2-years post-diagnosis. Results: 546 women participated (408 cancer, 138 benign), with a 24-month retention rate of 78%. Clinical and treatment characteristics of participants were similar to the Queensland gynecological cancer population, except for a higher proportion of early-stage cervical cancers recruited to LEGS compared with Queensland proportions (89% versus 55%, respectively). Discussion: Few imbalances were observed between participants with complete and incomplete follow-up data. The prospective design and collection of objective and patient-reported outcome data will allow comprehensive assessment of incidence and risk factors of lower-limb lymphedema.

Laparoscopic partial sleeve gastrectomy with fundoplication for gastroesophageal reflux and delayed gastric emptying.

A difficult management problem for the upper gastrointestinal surgeon exists when a patient presents with symptomatic and refractory severe delayed gastric emptying. Surgical treatment is further complicated by coexisting gastro-oesophageal reflux. No universal surgical strategy exists for this problem. A novel surgical strategy combines partial sleeve gastrectomy (SG) and hiatus hernia (HH) repair with fundoplication. A review of treating four such patients is described with objective outcome data. Overall, solid gastric emptying improved in all, from median 350 (163-488) min pre-operatively to 108 (84-135) at 10 months (3-24) post-operatively, corresponding to 67% improvement. Primary symptoms resolved in all; however, one patient had recurrent symptoms. GERD-HRQL also improved in all, from median 23 (3-25) to 4 (0-8) at 21 months (6-30, 83% improvement). Gas bloat improved in three. All had post-operative gastroscopies showing intact repair and absent oesophagitis, with no patient requiring post-operative PPI. Patient weight reduced by median 11% (7-20) post-operatively. There was no significant peri-operative morbidity. With careful patient selection and work-up, SG and HH repair with fundoplication may improve quality of life by coupling adequate reflux control with improved gastric emptying.

Gastrocnemius recession: a Panacea for What Ails the foot and ankle: commentary on an article by Deborah A. Nawoczenski, PT, PhD, et al.: "isolated gastrocnemius recession for achilles tendinopathy: strength and functional outcomes".

Commentary In recent years, there seems to be a trend toward performing large numbers of gastrocnemius recessions for a variety of pathological conditions of the foot and ankle. Whether it be as part of a complex flat or cavus foot reconstruction or to improve dorsiflexion, to offload forefoot pressures when treating diabetic ulcers, or, in the case of this paper, to decrease tension across the Achilles to treat tendinopathy, there is no doubt that the gastrocnemius recession has emerged as a vital tool in the armamentarium of the foot and ankle surgeon. While there are several case series that demonstrate promising results with regard to pain relief after gastrocnemius recession for Achilles tendinopathy1,2, the literature has not been as defined regarding the effect on plantar-flexion strength postoperatively3,4. Some of these limitations include small sample size, retrospective study designs with no preoperative strength-testing for comparison, and gastrocnemius recession procedures performed in conjunction with other major reconstructive procedures, making it difficult to determine what effect the recession would have in isolation. The present study does an admirable job of quantifying the pain relief, strength, and function following a gastrocnemius recession. The results are very encouraging with regard to reducing pain and improving patient-reported satisfaction. The results of strength-testing and self-reported sports function may be a little less promising; however, this comes as no surprise. We believe that this procedure is so effective because by lengthening the gastrocnemius, the muscle is weakened. In the case of tendinopathy, this muscle-weakening reduces the stress across the degenerative portion of the tendon, and with other pathological processes, it reduces the deforming force of the gastrocnemius-soleus complex. The decrease in calf circumference postoperatively seems to support this assumption. The authors also addressed the small sample size, but they did not separate the cases with insertional and midsubstance disease. We believe that it may be beneficial to look at these entities separately, as they are distinct clinical problems that may respond differently to an isolated recession. This current study certainly supports the use of gastrocnemius recession to relieve pain associated with Achilles tendinopathy. However, patients should be counseled that they might still have difficulty with high-impact and sporting activities postoperatively. These authors should be commended for this analysis of outcomes following a gastrocnemius recession for the treatment of Achilles tendinopathy, yet we should exercise some caution when interpreting their results. As they point out in the discussion section, it is difficult to interpret the strength data, as they did not have preoperative isokinetic strength measures, and it is possible that the patients with tendinopathy were stronger than the patients in the control group preoperatively. As the clinical indications for performing gastrocnemius recession continue to expand, it will be important to continue to look critically at the subjective and objective outcome data. Myotendinous recession has been used successfully to treat spasticity and contractures in the pediatric population as well as to increase motion by reducing the contractile force of the spastic muscle. We feel that the gastrocnemius recession is no different. Perhaps the perceived improvement in strength may come from removing both the pain and the inhibition that it causes by correcting the underlying pathological process, whether it be a painful foot deformity, ankle arthritis, or, in this study, tendinopathy. Nonetheless, gastrocnemius recession is here to stay, and we will continue to incorporate this procedure into our clinical practice, relying on its ability to weaken the gastrocnemius muscle to achieve the desired clinical result.

Leadership, safety climate, and continuous quality improvement

Successful amelioration of medical errors represents a significant problem in the health care industry. There is a need for greater understanding of the factors that lead to improved process quality and patient safety outcomes in hospitals. We present a research model that shows how transformational leadership, safety climate, and continuous quality improvement (CQI) initiatives are related to objective quality and patient safety outcome measures. The proposed framework is tested using structural equation modeling, based on data collected for 204 hospitals, and supplemented with objective outcome data from the Centers for Medicare and Medicaid Services. The results provide empirical evidence that a safety climate, which is connected to the chief executive officer's transformational leadership style, is related to CQI initiatives, which are linked to improved process quality. A unique finding of this study is that, although CQI initiatives are positively associated with improved process quality, they are also associated with higher hospital-acquired condition rates, a measure of patient safety. Likewise, safety climate is directly related to improved patient safety outcomes. The notion that patient safety climate and CQI initiatives are not interchangeable or universally beneficial is an important contribution to the literature. The results confirm the importance of using CQI to effectively enhance process quality in hospitals, and patient safety climate to improve patient safety outcomes. The overall pattern of findings suggests that simultaneous implementation of CQI initiatives and patient safety climate produces greater combined benefits.

Tongue-in-Groove Setback of the Medial Crura to Control Nasal Tip Deprojection in Open Rhinoplasty.

Overprojection of the nasal tip is a common problem in aesthetic Caucasian and Mediterranean rhinoplasty patients. In these patients, shortening of the conjoined medial crura frequently plays an important part in deprojection of the nasal tip. The combination of vertical incision maneuvers of the medial crura and tongue-in-groove (TIG) allows the surgeon to achieve significant control over projection, rotation and shape of the nasal tip. In this article we present our graduated approach towards nasal tip deprojection in aesthetic Caucasian and Mediterranean rhinoplasty together with a statistical analysis of overall success. This retrospective study based on 22 consecutive Caucasian or Mediterranean patients who had aesthetic, open deprojection rhinoplasty combining TIG with either footplate resection or medial crural overlay by one surgeon between 2009 and 2011. Aesthetical success was determined by statistical analysis of change in subjective body image in relation to nasal appearance, scored on five aesthetic 5-point Likert Scale questions and a 10 cm visual analog scale. Change in projection was calculated using a modified Goode method, applied on standardized pre- and postoperative photographs which were also used to measure change in rotation. Subjective body image in relation to nasal appearance improved from 15.14 to 6.55 (p < 0.01). The mean aesthetic VAS score improved from 3.32 to 7.91 (p < 0.01). Substantial deprojection was measured in 19 patients (86.4 %) with a mean deprojection ratio of 0.06 [range 0.02-0.16]. An increased projection ratio of 0.03 was encountered in one patient and in two patients projection was unchanged. Analysis of objective and subjective aesthetic outcome data suggest that our deprojection algorithm helps to deliver consistently good results in Caucasian and Mediterranean patients who require open deprojection rhinoplasty.

Leadership, safety climate, and continuous quality improvement: impact on process quality and patient safety.

Successful amelioration of medical errors represents a significant problem in the health care industry. There is a need for greater understanding of the factors that lead to improved process quality and patient safety outcomes in hospitals. We present a research model that shows how transformational leadership, safety climate, and continuous quality improvement (CQI) initiatives are related to objective quality and patient safety outcome measures. The proposed framework is tested using structural equation modeling, based on data collected for 204 hospitals, and supplemented with objective outcome data from the Centers for Medicare and Medicaid Services. The results provide empirical evidence that a safety climate, which is connected to the chief executive officer's transformational leadership style, is related to CQI initiatives, which are linked to improved process quality. A unique finding of this study is that, although CQI initiatives are positively associated with improved process quality, they are also associated with higher hospital-acquired condition rates, a measure of patient safety. Likewise, safety climate is directly related to improved patient safety outcomes. The notion that patient safety climate and CQI initiatives are not interchangeable or universally beneficial is an important contribution to the literature. The results confirm the importance of using CQI to effectively enhance process quality in hospitals, and patient safety climate to improve patient safety outcomes. The overall pattern of findings suggests that simultaneous implementation of CQI initiatives and patient safety climate produces greater combined benefits.

Long-term follow-up of first metacarpal extension osteotomy for early CMC arthritis.

The purpose of this study was to evaluate long-term outcomes of first metacarpal extension osteotomy for early trapeziometacarpal arthritis. We retrospectively reviewed 13 patients who underwent first metacarpal extension osteotomy at our institution between 1996 and 2005 and obtained subjective and objective outcome data. Mean follow-up was 9.9years (range 6 to 14years). Ten of the 13 patients (77%) were either satisfied or very satisfied with their results. Mean pain level was 2.00 on a scale of 1 (nonexistent) to 7 (unbearable). Mean QuickDASH score was 24.17, with a median score of 9.09. Mean pinch strength was 13.1lbs compared to 12.8lbs in the nonoperative extremity. Mean radial abduction of the thumb was 45.5° which was equal to the nonoperative extremity. Of the eight patients who agreed to repeat radiographs, five had no progression of degenerative changes compared to pre-op radiographs. Based on subjective and objective follow-up data, first metacarpal extension osteotomy can provide good long-term results in terms of patient satisfaction, pain relief, and upper extremity function. It is a reasonable alternative to ligament reconstruction in patients with early-stage trapeziometacarpal arthritis.

Surgical technique and effectiveness of microendoscopic discectomy for large uncontained lumbar disc herniations: a prospective, randomized, controlled study with 8 years of follow-up.

There is a long-held concept among spine surgeons that endoscopic lumbar discectomy procedures are reserved for small-contained disc herniation; 8-year follow-up has not been reported. The purpose of this study is to assess microendoscopic discectomy (MED) in patients with large uncontained lumbar disc herniation (the antero-posterior diameter of the extruded fragment is 6-12 mm or more on axial cuts of MRI) and report long-term outcome. One hundred eighty-five patients with MED or standard open discectomy underwent follow-up for 8 years. Primary (clinical) outcomes data included Numerical Rating Scale (NRS) for back and leg symptoms and Oswestry Disability Index (ODI) to quantify pain and disability, respectively. Secondary (objective) outcomes data included operative time, blood loss, postoperative analgesics, length of hospital stay, time to return to work, reoperation and complication rate, patient satisfaction index (PSI), and modified (MacNab) criteria. At the end of the follow-up, the leg pain relief was statistically significant for both groups. NRS back pain, ODI, PSI and MacNab criteria showed significant deterioration for control group. Secondary outcomes data of MED group were significantly better than the control group. Large, uncontained, lumbar disc herniations can be sufficiently removed using MED which is an effective alternative to open discectomy procedures with remarkable long-term outcome. Although the neurological outcome of the two procedures is the same, the morbidity of MED is significantly less than open discectomy. Maximum benefit can be gained if we adhere to strict selection criteria. The optimum indication is single- or multi-level radiculopathy secondary to a single-level, large, uncontained, lumbar disc herniation.

Ethical issues in surgical innovation.

Innovation is responsible for most advances in the field of surgery. Innovative approaches to solving clinical problems have significantly decreased morbidity and mortality for many surgical procedures, and have led to improved patient outcomes. While innovation is motivated by the surgeon's expectation that the new approach will be beneficial to patients, not all innovations are successful or result in improved patient care. The ethical dilemma of surgical innovation lies in the uncertainty of whether a particular innovation will prove to be a "good thing." This uncertainty creates challenges for surgeons, patients, and the healthcare system. By its very nature, innovation introduces a potential risk to patient safety, a risk that may not be fully known, and it simultaneously fosters an optimism bias. These factors increase the complexity of informed consent and shared decision making for the surgeon and the patient. Innovative procedures and their associated technology raise issues of cost and resource distribution in the contemporary, financially conscious, healthcare environment. Surgeons and institutions must identify and address conflicts of interest created by the development and application of an innovation, always preserving the best interest of the patient above the academic or financial rewards of success. Potential strategies to address the challenges inherent in surgical innovation include collecting and reporting objective outcomes data, enhancing the informed consent process, and adhering to the principles of disclosure and professionalism. As surgeons, we must encourage creativity and innovation while maintaining our ethical awareness and responsibility to patients.

Noise-related sleep disturbances: does gender matter?

Women sleep differently and report differently about sleep disturbances than men. However, it is unclear whether the sleep of women and men is affected differently by traffic noise exposure. We aimed to address gender specific noise effects by using objective and subjective exposure measures as well as objective and subjective outcome data. In a questionnaire survey conducted in 2008 including 733 women and 533 men from Basel, Switzerland, with follow-up 1 year later, we collected data on subjective sleep disturbances and annoyance to road traffic noise. Objective noise exposure data was obtained using validated propagation models. In a nested diary study with 119 participants, objective sleep efficiency and sleep duration was measured by means of actigraphic devices for 1551 nights. Data were analyzed using random intercept mixed-effects multilevel regression models adjusted for relevant confounding factors. Objectively measured sleep duration in highly exposed men (>55 dB) was reduced by 1.5 h (95% confidence interval [CI]: 2.3-0.8 h) compared with low exposed men (<30 dB). No noise effect on sleep duration was observed in women. The association of modeled noise exposure with self-reported sleep quality rating was also more pronounced in men (-0.8 unit, 95% CI: -1.4 to -0.2) than in women (-0.3 unit, 95% CI: -0.8 to 0.2). However, in highly annoyed women reduction in sleep quality and well-being rating tended to be stronger than in highly annoyed men. Our study provides some indications that noise exposure affects men's sleep differently than women's sleep, which may have distinct long-term health consequences.

Stereotactic radiotherapy (SABR) for the treatment of primary non-small cell lung cancer; Systematic review and comparison with a surgical cohort

Background and purposeTo assess the efficacy of stereotactic ablative radiotherapy (SABR) for the treatment of non-small cell lung cancer (NSCLC) through a systematic review of all relevant publications from 2006 to the present compared to controls treated with surgery. In the absence of Grade I evidence, the objective outcome data should form the basis for planning future studies and commissioning SABR services. Materials and methodsStandard systematic review methodology extracting patient and disease characteristics, treatment and outcome data from published articles reporting patient data from populations of 20 or more Stage I NSCLC patients treated with SABR with a median follow up of minimum of 1year. The individual outcome measures were corrected for stage and summary weighted outcome data were compared to outcome data from a large International Association for the Study of Lung Cancer (IASLC) cohort matched for stage of disease with survival as the principal endpoint and local control (local progression free survival – local PFS) as the secondary endpoint. ResultsForty-five reports containing 3771 patients treated with SABR for NSCLC were identified that fulfilled the selection criteria; both survival and staging data were reported in 3171 patients. The 2year survival of the 3201 patients with localized stage I NSCLC treated with SABR was 70% (95% CI: 67–72%) with a 2year local control of 91% (95% CI: 90–93%). This was compared to a 68% (95% CI: 66–70) 2year survival of 2038 stage I patients treated with surgery. There was no survival or local PFS difference with different radiotherapy technologies used for SABR. ConclusionsSystematic review of a large cohort of patients with stage I NSCLC treated with SABR suggests that survival outcome in the short and medium term is equivalent to surgery for this population of patients regardless of co-morbidity. As selection bias cannot be assessed from the published reports and treatment related morbidity data are limited, a direct comparison between the two treatment approaches should be a priority. In the meantime, SABR can be offered to stage I patients with NSCLC as an alternative to surgery.

Risk factors for long‐term failure of the retropubic tension‐free vaginal tape procedure

To investigate potential risk factors for long-term (10-year) subjective and objective failure of the retropubic tension-free vaginal tape procedure (TVT). Secondary risk analysis was performed using data from a recently published multi-center study that were merged with additional preoperative and operative data individually stored in the Norwegian Female Incontinence Registry (NFIR). Subjective data from 483 women and objective data from 327 women were obtained 10 years after retropubic TVT surgery. A validated questionnaire was used for subjective outcome data and a stress test for objective outcome data. Uni- and multivariate logistic regression analyses were performed using preoperative and operative variables extracted from the NFIR. The outcomes were 10-year subjective failure defined as women stating not cured, and objective failure was defined as ≥1 g urinary leakage during stress testing. Age ≥56 years at the time of TVT surgery was associated with both long-term subjective failure (adjusted OR: 2.15, CI: 1.40-3.30) and long-term objective failure (adjusted OR: 2.81, CI: 1.30-6.09). Mixed incontinence was associated with subjective, but not objective failure if the urgency incontinence component was severe (adjusted OR: 2.33, CI: 1.27-4.28). Surgical complications occurring at or immediately following surgery were associated with both outcomes in the univariate analyses, but were only an independent risk factor for subjective failure in the multivariate analysis (adjusted OR: 3.02, CI: 1.53-5.95). Age ≥56 years, a severe preoperative urgency incontinence component and surgical complications seem to represent independent risk factors for long-term (10-year) failure.

Preparing for the bundled-payment initiative: the cost and clinical outcomes of reverse shoulder arthroplasty for the surgical treatment of advanced rotator cuff deficiency at an average 4-year follow-up

The purpose of this study is to report on cost, outcomes, reliability, and safety of reverse shoulder arthroplasty (RSA) in patients with symptomatic advanced rotator cuff deficiency. Fifty-five primary RSA patients operated on at a single institution by a single surgeon were prospectively studied for a mean of 48 months (range, 31-71 months). For each patient, validated subjective and independently evaluated objective outcome data were collected to determine clinical reliability. In addition, safety, defined as major complications, as well as direct costs specific to each patient, were collected and analyzed. There were significant improvements (P<.05) in all clinical measures with the exception of the general health and vitality components as well as the mental component summary scores of the Short Form 36 version 2 (SF-36v2). In addition, the majority of the patients met the criteria set forth for clinical reliability (53 of 55 [96%]) and safety (49 of 55 [89%]). The mean total 4-year cost was $24,661, with the hospitalization accounting for 92% of this cost. Fiscal year was found to be responsible for the greatest fluctuation in total cost (P<.001). In addition, a lower comorbidity burden (P<.001), a higher preoperative extremity impairment rating (P<.001), higher postoperative role-emotional component scores on the SF-36v2 (P=.001), and lower postoperative social functioning component scores on the SF-36v2 (P=.005) were correlated with less cost. The mean 4-year total cost of $24,661 allowed the purchase of treatment with RSA, leading to a greater than 5-fold reduction in pain and a 70% improvement in shoulder function with a small risk ofharm.

Curricular Flexibility in the Pre-Clinical Years Promotes Medical Student Scholarship

Medical student research is recognized as a critical component of undergraduate medical education. Current studies focusing on curricular improvements to promote student research are limited by lack of objective outcome data. At the Mayo Medical School, research has been an integral component of the curriculum since its inception in 1972. In 2006, selectives (periods of time free from competing didactic or clinical responsibilities) were implemented, which permitted students flexibility in their pre-clinical years to pursue service projects, research endeavors, and career exploration. The purpose of this study was to quantify the effects of this curricular revision on research productivity by Mayo medical students. Publications by Mayo medical students graduating in the 2004-2011 time period were queried in the PubMed database. The number, impact factor, and time to publication for these publications was assembled and analyzed in a cohort of students that graduated before and after selectives were implemented. We found that students who participated in selectives published more papers, papers with a higher impact factor, and published papers earlier in their training than students who graduated prior to the implementation of selectives. We propose that selectives are an effective means to increase research productivity in the Mayo medical school curriculum.

Traumatic Brain Injury: An Objective Model of Consent

The aim of this paper was to explore the issue of consent when considering the use of a life saving but not necessarily restorative surgical intervention for severe traumatic brain injury. A previous study has investigated the issue amongst 500 healthcare workers by using a two-part structured interview to assess opinion regarding decompressive craniectomy for three patients with varying injury severity. A visual analogue scale was used to assess the strengths of their opinions both before and after being shown objective outcome data. Opinions were assessed in a number of scenarios, one of which was that the participants themselves were the injured party. The implication, which was clearly stated, was whether they would provide consent for the procedure to be performed. The study demonstrated that participants were relatively risk aversive in regards to survival with severe disability especially when the injury was severe and there was high probability of that outcome occurring. This finding was not however universal and a minority of participants would provide consent even when the possibility of survival with severe disability was very high. The obvious difficulty comes when considering consent in patients who are unable to express their wishes. In order to address this issue we propose a model of consent based on a balance of the various factors that seem to be of material relevance. These include the severity of the injury, the willingness or otherwise to accept survival with severe disability and the willingness to “risk” the possibility of an unacceptable outcome in order to achieve an acceptable outcome.

Defining “The Elderly” Undergoing Major Gastrointestinal Resections

"The elderly" is an often used but poorly defined descriptor of surgical patients. Investigators have used varying subjectively determined age cutoffs to report outcomes in the elderly. We set out to use objective outcomes data to determine the "at-risk" elderly population. 129,331 patients identified from the ACS-NSQIP database (2005-2010) undergoing major gastrointestinal resections. Mortality. Locally weighted regression was used to fit the trend line of mortality over age. Receiver operating characteristic analysis was used to identify the "predictive age" for mortality. Mortality steadily increases with age. On receiver operating characteristic analysis, there is a nonlinear transition zone (50-75 years of age) flanked by 2 linear zones on either end. The younger linear zone showed a low mortality increase (0.5% per decade). Larger mortality increase with age (5.3% per decade) was observed at the older age end. Similar patterns were observed for large-volume surgical subtypes, with clustering of a "critical age" beyond which mortality increases dramatically at 75 ± 2 years. Receiver operating characteristic analysis identified the "optimum age" for mortality being 68.5 years (area under the curve = 0.72, sensitivity = 66.6%, and specificity = 65.5%). Mortality risk for major gastrointestinal surgical resections starts increasing at 50 years of age, and at 75 years of age, it starts increasing very rapidly. The optimum age of 68.5 years predicts mortality with the best combination of sensitivity and specificity. These ages should be used to standardize outcome data and focus perioperative resources to improve outcomes.

World Medical Leaders Declare that Pain Treatment Is a Human Right … and It Couldn't Come at a Worse Time

To be a pain specialist during these unpredictable changes in health care delivery is fraught with danger to one's professional existence. The medical management of pain has become so over-regulated by state and federal drug agencies that one step in the wrong direction can result in fines, loss of license, and even imprisonment. Attorneys now have the best possible scenario for suing physicians—if one prescribes too little pain medication or too much pain medication, one can be sued. Interventional pain specialists are constantly being challenged to produce double-blinded, randomized controlled study-equivalent data to justify their invasive procedures. Now, Centers for Medicaid & Medicaid Services (CMS) has teamed up with the Rand Corporation to examine outcome data on certain high-use, high-cost procedures to determine their cost-effectiveness. In some cases such as intradiscal electrothermal therapy (IDET) procedures for Medicare patients, CMS will not pay for the procedure based on lack of objective and positive outcome data. Thus, today's pain specialist must traverse the “Scylla and Charybdis” of multiple government agencies and aggressive attorneys in order to provide care for some of the most miserable and suffering patients in the world. In January 2011, I took part in a multinational, multidisciplinary summit in DeBilt, The Netherlands that addressed the concept of pain treatment being a human right. That's correct; a right to life, liberty, pursuit of happiness, and relief from pain and suffering. On the surface, one might think this group was a throwback to the Haight-Ashbury days of peace and love. On the contrary, world standards for effective pain relief are so varied that many terminally ill cancer patients in certain countries are denied basic opioid analgesics for palliative measures. This cause is appropriate and justified, yet also realistic as to the extent its impact may have …