The developmental potential of mature oocytes derived from rescue in vitro maturation.

OBJECTIVE: To examine the developmental competence of immature oocytes in stimulated cycles, that matured after rescue in vitro maturation (IVM) compared with their sibling in vivo matured oocytes. DESIGN: Retrospective cohort study. SETTING: IVF clinic. PATIENTS: A total of 182 patients underwent 200 controlled ovarian stimulation cycles with intracytoplasmic sperm injection cycles in which immature oocytes were retrieved and at least one mature oocyte was obtained through rescue IVM. INTERVENTION: In vitro culture of immature germinal vesicle (GV) and metaphase I (MI) oocytes, retrieved in stimulated cycles. MAIN OUTCOME MEASURES: Fertilization rate, cleavage rate, blastulation rate, ploidy of embryos evaluated using preimplantation genetic testing for aneuploidy, morphokinetic parameters and pregnancy outcomes. RESULTS: In total, 2,288 oocytes were retrieved from 200 cycles. After denudation, 1,056 of the oocytes (46% ± 16%) were classified as metaphase II (MII). A total of 333/375 (89%) of MI oocytes and 292/540 (54%) of GV oocytes matured overnight and underwent intracytoplasmic sperm injection. The fertilization rates of matured oocytes from MI rescue IVM (R-MI) and from GV rescue IVM (R-GV) were comparable with those of their sibling MII oocytes (71% vs. 66%; 66% vs. 63%, respectively). Early cleavage rates (80% ± 35% vs. 92% ± 20%; 80% ± 42% vs. 95% ± 28%, respectively) and blastulation rates (32 ± 40% vs. 62 ± 33%; 24 ± 37% vs. 60 ± 35%, respectively) were significantly decreased in rescue IVM matured oocytes (R-oocytes)-derived zygotes, but the blastocyst (BL) euploidy rate and "good quality" BL rate were comparable with those of MII sibling-derived embryos. In addition, rescue IVM embryos showed significantly higher levels of multinucleation at the 2- and 4-cell stages, as well as higher rates of zygote direct cleavage from one to 3 to 4 cells. Overall, 21 transfers of rescue IVM embryos resulted in 3 healthy live births. CONCLUSIONS: For patients with a low maturation rate and/or low numbers of mature oocytes at retrieval, rescue IVM may contribute more competent oocytes and additional viable BLs for transfer from the same stimulation cycle, maximizing the chances for pregnancy and live birth.

Insertion of a urinary catheter on admission lowers acute kidney injury incidence in patients with hip fractures.

PURPOSE: Acute kidney injury (AKI) is a common adverse event in patients undergoing hip fracture repair surgery, increasing morbidity and mortality. Our study hypothesis was that routine insertion of a urinary catheter, on admission to the hospital or immediately before surgery, will reduce AKI incidence in hip fracture patients. METHODS: Determined by alternating days of admission, a urinary catheter was inserted routinely on admission (catheter group) or as needed (non-catheter group) in 250 consecutive patients who presented with a hip fracture to our emergency department. The incidence of AKI according to the KDIGO criteria and morbidity and mortality were compared between the study groups. RESULTS: The overall incidence of AKI was 11.6% (29/250). The catheter group (N = 122) had a significantly lower rate of AKI (6.6% vs. 16% p = 0.018). At 12-month follow-up, the overall mortality was 10.8% (27/250), in-hospital 7.4% (2/27), short-term (within 30 days) 7.4% (2/27), and long-term (30 days to 1 year) 85.8% (23/27). All in-hospital mortality occurred in the AKI group. Patients with no AKI had a better survival rate; however, the difference was not significant (p-value = 0.21). Mortality rate was lower in the catheter group but not significant (8.2% compared with 13.8% in the non-catheter group, p = 0.225). Post-operative respiratory and cardiac complications were more frequent in the AKI group (p = 0.02 and 0.043 accordingly). CONCLUSIONS: Insertion of a urinary catheter upon admission or before surgery lowered AKI incidence significantly. Peri-operative AKI was associated with higher rates of post-operative complications and worse survival.

Self-reported pain during the initial postoperative period following open lumbar spine fusion surgery does not correlate with the number of levels fused: A prospective trial of 40 patients.

BACKGROUND: Current spine postoperative pain control protocols consider the expected pain following spine fusion surgery to correlate with surgical extent, that is, the greater the number of operated vertebrae, the greater the postoperative pain. Due to this assumption, Enhanced Recovery After Surgery (ERAS) protocols are principally applied to minimally invasive and percutaneous spine surgery and less to open extensive spine fusion operations. The aim of this study was to determine whether postoperative pain does in fact correlate with the surgical extent, potentially opening the door to non-narcotic postoperative pain protocols for this patient subset. MATERIALS AND METHODS: Forty consecutive patients, undergoing open posterior spine surgery, were evaluated for postoperative pain during the first 72 after surgery. All patients were then divided into two groups according to the number of spine levels fused, and the correlation between the number of fusion levels and self-reported pain was analyzed statistically. RESULTS: Self-reported pain levels were not found to correlate with the extent of the spine operation. CONCLUSIONS: As "bigger operation" does not necessarily equate with "bigger pain," adequate postoperative pain control after extensive spine fusion surgery might be achieved without the routine use of narcotic medication, as practiced after minimally invasive and percutaneous surgery. Additional prospective randomized trials are needed to further substantiate this conclusion.

Effectiveness of intra-venous steroids for preventing surgery for lumbo-sacral radiculopathy secondary to intervertebral disc herniation: a retrospective study of 213 patients.

The natural history of lumbar disc herniation with radiculopathy is favorable, with 95% of patients expected to be pain-free within 6 months of onset. Despite the favorable prognosis, operative treatment is often chosen by patients unable to "ride out" the radicular episode. Prospective studies comparing surgical with non-surgical treatment have demonstrated similar long-term results. We conducted a retrospective case-series study of patients with a lumbar disc herniation and intractable radicular pain without significant neurological deficits treated with intra-venous dexamethasone. The primary outcome measure was whether the patient had undergone operative treatment within 1 year of receiving the intravenous steroid treatment. 213 patients met our inclusion criteria. 30 were lost to follow-up and 2 had died before completing 1 year of follow-up. Of the remaining 181 patients, 133 (73.48%) had not undergone surgery within 1 year of receiving intra-venous steroid treatment while 48 (26.51%) had undergone surgery. 6 (3.31%) of the patients had undergone surgery more than 1 year of receiving IV steroid treatment. Intravenous steroid treatment in our retrospective series was approximately 30% better at preventing the need for surgery than the reported outcomes of conservative treatment in randomized controlled trials previously published.

Inadequate deltoid muscle penetration and concerns of improper COVID mRNA vaccine administration can be avoided by injection technique modification.

BACKGROUND: Recent phase-3 clinical trials have demonstrated very encouraging results for mRNA based vaccines against COVID-19. Current FDA and manufacturer guidelines mandate intramuscular administration of these vaccines, as other administration routes may not provide the same levels of effectiveness and safety. Observing the vast amount of published media images of persons receiving their vaccines, the authors noted in many cases the injection technique involved skin bunching, raising concerns of inadequate deltoid muscle penetration and consequent lowered vaccine efficacy. Our study hypothesis was that skin bunching will increase the skin-to-muscle distance over 20 mm, the maximal distance allowing the required 5 mm muscle penetration with a 25 mm needle. MATERIALS AND METHODS: 60 adult volunteers from our hospital staff were recruited, and using ultrasound, the skin-to-muscle distance measured in three positions: flat, skin bunching and muscle bunching. The skin-to-muscle distance difference and correlation with gender and BMI were calculated. RESULTS: Skin bunching significantly increased the skin-to-muscle distance in all subjects. In 6 (10%) subjects, this increase exceeded the 20 mm limit. Having a skin-to-deltoid distance of 20 mm or more strongly correlated with a BMI of 30 or more. CONCLUSIONS: Skin bunching will prevent adequate intramuscular injection of vaccines in a small percentage of persons, but as hundreds of millions are expected to receive mRNA vaccines in the coming months, the multiplied result can have significant personal and societal consequences for millions of people globally, especially in obese populations, and therefore this practice should be strictly discouraged.

Percutaneous, PMMA-augmented, pedicle screw instrumentation of thoracolumbar ankylotic spine fractures.

INTRODUCTION: Fractures in the ankylotic spine may have an insidious presentation but are prone to displace with devastating consequences. The long lever arm of ankylosed spine fragments may lead to pulmonary and great vessel injury and is difficult to adequately immobilize. Conservative treatment will produce in many cases poor outcomes with high morbidity and mortality. Open surgical treatment is also fraught with technical difficulties and can lead to major blood loss and prolonged operative times. In recent years, percutaneous instrumentation of non-ankylotic spine fractures has gained popularity, producing similar outcomes to open surgery with shorter operative times and reduced blood loss and hospital length of stay. We describe our experience implementing these techniques in ankylotic spine patients. METHODS: We retrospectively retrieved from our hospital's electronic health records all patients treated for thoracolumbar spine fractures between 2008 and 2015 with a diagnosis of ankylosing spondylitis (AS) or diffuse idiopathic skeletal hyperostosis (DISH). Operative and postoperative data, results, and complications were tabulated, and radiographic parameters were evaluated. RESULTS: Twenty-four patients with ankylotic spine disease underwent percutaneous augmented instrumentation between 2008 and 2015. The mean age was 76. All patients had at least one comorbidity. The mean number of ankylosed levels was 14. Mean operative time was 131 min. The average postoperative hemoglobin decrease was 1.21 gr/%, with only 4 patients requiring blood transfusion. 45.8% of the patients had postoperative medical complications. One patient (4.2%) had a superficial postoperative infection, and one patient died in hospital. The average hospital length of stay was 14.55 days. All patients retained their preoperative ASIA grades, and 3 improved one grade. All patients united their fractures without losing reduction. CONCLUSIONS: PMMA-augmented percutaneous instrumentation is an attractive surgical option for this difficult patient subset, especially when compared to other available current alternatives.

Suspension of fertility treatment during the COVID-19 pandemic: views, emotional reactions and psychological distress among women undergoing fertility treatment.

RESEARCH QUESTION: What are the views and emotional reactions of patients towards the suspension of fertility treatment during the COVID-19 pandemic, and what are the factors affecting their psychological distress? DESIGN: A cross-sectional study conducted in an academic fertility centre. Online questionnaires were distributed between 18 April 2020 and 23 April 2020 to patients whose treatment cycle had been postponed or discontinued. The outcome measures included agreement with the reproductive society guidelines to postpone treatments; willingness to resume treatments, given the choice; patients' emotional reactions; and psychological distress level, measured by the Mental Health Inventory validated scale. A multivariate linear regression was conducted to identify factors associated with psychological distress. RESULTS: Because of the small number of male respondents, only women were included in the analysis (n = 181). Forty-three per cent expressed disagreement with the guidelines and 82% were willing to resume treatments, given the choice. Sadness and anxiety were the most common emotional reactions expressed towards the guidelines. In the multivariate analysis, COVID-19-related anxiety (B = 0.145, P = 0.04) and disagreement with treatment suspension (B = -0.44, P = 0.001) were found to be significantly associated with patients' psychological distress. Background characteristics of patients did not contribute significantly to their distress. CONCLUSIONS: Suspension of fertility treatment during the initial phase of the COVID-19 pandemic was associated with patients' negative emotional reactions. Anxiety related to COVID-19 and disagreement with treatment suspension were found to be significantly associated with psychological distress among women undergoing fertility treatment, regardless of their background characteristics. Our findings suggest the need to monitor the mental health of patients and provide psychological support should a shutdown of fertility care re-occur.

Matching actual treatment with patient administration-route-preference improves analgesic response among acute low back pain patients-a randomized prospective trial.

BACKGROUND: Accommodating a patient's treatment preference has been reported to promote greater responsiveness and better clinical outcomes. The effect of administration route preference (ARP) on the individual analgesic response has not been extensively examined to date. This study aimed to investigate whether ARP-matched treatment, i.e., individualized intramuscular (IM) or oral (PO) analgesic administration according to patient choice, would increase the analgesic effect. METHODS: In this prospective randomized study, we collected 38 patients with acute low back pain (aLBP) presenting at the emergency room of the Galilee Medical Center (Naharia, Israel) and asked them to report their ARP for analgesics. Regardless of their reported preference, they received either PO or IM diclofenac according to the treating physician's preference. Pain intensity was self-reported using the numeric pain score (NPS) before and during the first hour after drug administration. RESULTS: Both groups receiving PO or IM administration reported similar initial pain on admission, (NPS 8.63 ± 1.5 and 8.74 ± 1.6, respectively) and the same magnitude of pain reduction. However, patients who received the drug in their desired route (oral or injection) had a significantly greater reduction in pain levels (4.05 ± 2.8) as compared with patients who received the undesired route (2.08 ± 1.8), p < 0.05. CONCLUSIONS: These findings support the hypothesis that individualized ARP-matched treatment in aLBP improves therapeutic outcomes, although further studies with larger cohorts are needed.

Nylon Skin Sutures Carry a Lower Risk of Post-Operative Infection than Metal Staples in Open Posterior Spine Surgery: A Retrospective Case-Control Study of 270 Patients.

Background: Controversy still exists regarding the optimal method for post-operative skin closure in orthopedic surgery. In total knee replacement, closure with metal staples is faster but carries a higher surgical site infection (SSI) risk. Other studies have found differing results in foot and ankle and hip surgery. Very little evidence exists on this subject after spine surgery. The aim of this study was to determine whether closure of the skin incision in open posterior spine surgery carries a different rate of post-operative SSI when using nylon sutures compared with metal staples. Methods: Up to 2006, virtually all skin incisions at our spine surgery unit were closed with metal staples and from 2006 onward with nylon sutures. This was a retrospective historical control study comparing the incidence of SSIs in patients operated on before (n = 127; staples) and after (n = 143; sutures) the transition date. Results: The staples group had an overall 11.8% combined deep and superficial infection rate whereas the nylon suture group had a 4.2% rate (p = 0.017). The two groups also differed in the type of antibiotic prophylaxis used, likelihood of incisional discharge, and the number of days the vacuum drains remained. Conclusions: In our departmental setting, closure of the skin incision with nylon sutures after open posterior spine surgery carried a significantly lower risk of post-operative SSI compared with metal staples. The generalizability of our findings is unclear, but they warrant further investigation.

Intra-discal drain insertion for culture and drainage of pyogenic spondylodiscitis: A one-step diagnostic and therapeutic procedure.

BACKGROUND: Pyogenic spondylodiscitis is diagnosed in recent years at higher rates due to the aging population, increased survival of chronic and immune suppressed patients, and the higher rate of invasive procedures leading to bacterial seeding or direct contamination of the disc space. Treatment guidelines encourage bacterial sampling before initiation of antibiotic therapy, and drainage of pus collections. We present our experience with percutaneous CT-guided drain insertion into the disc space itself as a one-step procedure for both culturing and subsequent continuous drainage of the infected disc space. MATERIALS AND METHODS: We retrospectively reviewed all cases of pyogenic spondylodiscitis admitted to our spine surgery unit during the past five years and treated with CT-guided percutaneous drain insertion into the infected disc space. All patients were followed until complete resolution of the infection. RESULTS: We retrieved electronic records of 12 patients, none presenting with neurological compression symptoms. Cultures taken at the time of drain insertion were positive in 10 patients (83.3%), much higher than the reported yield for needle aspiration (14-48%) and comparable to the yield of open biopsy. In all patients complete resolution of the infection was reached, determined by clinical, laboratory, and imaging parameters. CONCLUSIONS: Our retrospective case series demonstrates the feasibility and effectiveness of intra-discal CT-guided drainage of an infected disc space. The procedure does not add much burden to current practice as disc-space sampling for culture is commonly performed anyway, and adds the benefit of direct drainage of the pus at its source.

Policy for reducing unplanned pregnancies and repeat unplanned pregnancies rates in Israeli Defense Force.

Israel has compulsory military service, beginning at the age of 18. Women serve about two years and men for about three years. However, de facto only some of the potential service entrants are recruited. Among women, those who enlist are mainly secular Jews who are unmarried; among men, most of the ultra-Orthodox Jews do not enlist. In addition, only a fraction of the recruits chooses to turn the military service into a career and sign up for additional service as professional military personal (officers and non-commissioned officers). Thus, military personnel are not representative of the general Israeli population, even after controlling for age.The rate of pregnancies among female soldiers (obligatory service) in the Israeli army is low, but almost all pregnancies in this group are unplanned and most result in termination of pregnancy. An unplanned pregnancy carries a direct impact on the service of that female soldier and consequently on the military's routine.In a recent article in the Israel Journal of Health Policy Research (IJHPR), Rottenstreich et al. (IJHPR 7:42, 2018) describe a retrospective cohort study designed to evaluate the prevalence and risk factors for repeated unintended pregnancies among this population of female soldiers.This commentary presents the current IDF policy intended to further reduce unplanned pregnancies and repeat unplanned pregnancies rates. We also suggest additional tools to support evidence-based strategy planning in this field.

Efficacy of Palmitoylethanolamide for Pain: A Meta-Analysis.

BACKGROUND: Palmitoylethanolamide (PEA) is a cannabimimetic compound that has been investigated as an analgesic agent in animal models and clinical trials. OBJECTIVES: We conducted a meta-analysis to examine the efficacy of PEA for treating pain in randomized, controlled trials. STUDY DESIGN: Systematic review and meta-analysis. SETTING: This meta-analysis examined all randomized, controlled trials involving the effect of PEA on pain score. METHODS: We searched PubMed and Embase for randomized, active or placebo-controlled trials of PEA for the treatment of acute or chronic pain. Our primary outcome was the weighted mean difference in visual analog pain scales of PEA treatment compared to inactive controls. RESULTS: We identified 10 studies including data from 786 patients who received PEA and 512 controls for inclusion in our systematic review. Eight trials included an inactive control group and were included in the meta-analysis. PEA was associated with significantly greater pain reduction compared to inactive control conditions (WMD = 2.03, 95% CI: 1.19 - 2.87, z = 4.75, P < 0.001). Use of placebo control, presence of blinding, allowance for concomitant treatments, and duration or dose of PEA treatment did not affect the measured efficacy of PEA. All-cause dropout was non-significantly reduced in the PEA group compared to inactive control conditions (RR = 0.36, 95% CI: 0.10 - 1.26, z = -1.60, P = 0.11). LIMITATIONS: This meta-analysis relied on a relatively small number of trials across a variety of conditions causing pain with differing trial designs. Overall quality of the underlying studies and assessment of side effects were often poor. CONCLUSIONS: PEA may be a useful treatment for pain and is generally well tolerated in research populations. Further, well-designed, randomized, placebo-controlled trials are needed to provide reliable estimates of its efficacy and to identify less serious adverse events associated with this compound. KEY WORDS: PEA, palmidrol, palmitoylethanolamide, efficacy, pain, pain management, meta-analysis.

Impact of the 12-Gene Colon Cancer Assay on Clinical Decision Making for Adjuvant Therapy in Stage II Colon Cancer Patients.

OBJECTIVES: To evaluate the impact of the 12-gene Colon Cancer Recurrence Score Assay-a clinically validated prognosticator in stage II colon cancer after surgical resection-on adjuvant treatment decisions in T3 mismatch repair proficient (MMR-P) stage II colon cancer in clinical practice. METHODS: This retrospective analysis included all patients with T3 MMR-P stage II colon cancer (Clalit Health Services members) with Recurrence Score results (time frame January 2011 to May 2012). Treatment recommendations pretesting were compared with the treatments received. Changes were categorized as decreased (to observation alone/removing oxaliplatin from the therapy) or increased (from observation alone/adding oxaliplatin to the therapy) intensity. RESULTS: The analysis included 269 patients; 58%, 32%, and 10% of the values were in the low (<30), intermediate (30-40), and high (≥41) score groups, respectively. In 102 patients (38%), treatment changed post-testing (decreased/increased intensity 76/26 patients). The overall impact was decreased chemotherapy use (45.0% to 27.9%; P < 0.001). Treatment changes occurred in all score groups, but more frequently in the high (change rate 63.0%; 95% confidence interval [CI] 42.3%-80.6%) than in the intermediate (30.6%; 95% CI 21.0%-41.5%) and low (37.6%; 95% CI 30.0%-45.7%) score groups. The direction of the change was consistent with the assay result, with increased intensity more common in higher score values and decreased intensity more common in lower score values. CONCLUSIONS: Testing significantly affected adjuvant treatment in T3 MMR-P stage II colon cancer in clinical practice. The study is limited by its design, which compared treatment recommendations pretesting to actual treatments received post-testing, lack of a control group, and nonassessment of confounding factors that may have affected treatment decisions.

Campylobacter coli infection causing second trimester intrauterine growth restriction (IUGR): a case report and review of the literature.

Campylobacter is a gram-negative, microaerophilic, curved rod and a normal resident of the gastrointestinal flora and may be the cause of disease in animals. Transmission to humans occurs by ingestion of contaminated food or by direct contact with infected animals. In the past few decades, an increasing number of reports have implicated the presence of this organism in human abortions as well. An infectious mechanism due to primary placental inflammatory damage followed by secondary damage to the fetus following placental insufficiency and ischemia was suggested. The most common species of Campylobacter are Campylobacter jejuni and Campylobacter coli, which are classically associated with enteritis in humans. We present a rare case of mid-gestation intrauterine growth restriction (IUGR) associated with maternal bacteremia caused by C. coli infection. Our literature review focuses on Campylobacter infections occurring in the second and third trimesters of pregnancy. In all cases, mild maternal symptoms consisting of fever and weakness were presented. However, associated adverse fetal outcome, including abortions, IUGR or preterm labor may occur more frequently than anticipated. Our report strengthens the importance of awareness to this finding and focuses the need to consume properly cooked meat during pregnancy.

Oncologists' and family physicians' views on value for money of cancer and congestive heart failure care.

BACKGROUND: Previous studies suggest that cancer-related interventions are valued by policy makers more favorably than interventions for other medical conditions, but the views of practicing physicians have not yet been assessed in Israel. Attitudes and judgments of practicing physicians may assist decision-makers in their deliberations on coverage of new technologies. We conducted a national survey in Israel among oncologists and family physicians to explore their views on access to care, coverage decisions and treatment recommendations for cancer and congestive heart failure (CHF) patients. METHODS: We administered a web-based survey to 300 family physicians and 156 oncologists. The questionnaire included 24 statements and physicians were asked to indicate their level of agreement with each statement on a 5-point Likert scale, ranging from "strongly agree" to "strongly disagree". Where relevant, physicians were asked to express their views on interventions for cancer and CHF respectively. RESULTS: Response rates were 39% for family physicians and 36% for oncologists. Participants expressed similar views on cancer and CHF care and no significant differences were found between the two medical specialties. More than 85% of physicians believe that inclusion of a treatment in the National List of Health Services (NLHS) strongly affects their patients' access to care. Approximately 80% suggest that more use of comparative-effectiveness and cost-effectiveness analysis is needed in coverage decisions. The vast majority of respondents (75%) suggest that assessment of value-for-money should be made by an independent (academic) institution or the national committee responsible for recommending coverage decisions, Seventy percent believe that treatments not included in the NLHS should be included in supplementary health insurance programs and only a small minority of respondents (<30%) believe that cancer-related interventions should receive higher priority than non-cancer interventions in coverage decisions. CONCLUSIONS: Our findings suggest that both oncologists and family physicians value cancer and CHF interventions equally. We could not find evidence for a "cancer premium" as implied from previous surveys and analysis of coverage decisions in various countries.

Which is more valuable, longer survival or better quality of life? Israeli oncologists' and family physicians' attitudes toward the relative value of new cancer and congestive heart failure interventions.

OBJECTIVES: We determined how Israeli oncologists and family physicians value life-prolongation versus quality-of-life (QOL)-enhancing outcomes attributable to cancer and congestive heart failure interventions. METHODS: We presented physicians with two scenarios involving a hypothetical patient with metastatic cancer expected to survive 12 months with current treatment. In a life-prolongation scenario, we suggested that a new treatment increases survival at an incremental cost of $50,000 over the standard of care. Participants were asked what minimum improvement in median survival the new therapy would need to provide for them to recommend it over the standard of care. In the QOL-enhancing scenario, we asked the maximum willingness to pay for an intervention that leads to the same survival as the standard treatment, but increases patient's QOL from 50 to 75 (on a 0-100 scale). We replicated these scenarios by substituting a patient with congestive heart failure instead of metastatic cancer. We derived the incremental cost-effectiveness ratio per quality-adjusted life-year (QALY) gained threshold implied by each response. RESULTS: In the life-prolongation scenario, the cost-effectiveness thresholds implied by oncologists were $150,000/QALY and $100,000/QALY for cancer and CHF, respectively. Cost-effectiveness thresholds implied by family physicians were $50,000/QALY regardless of the disease type. Willingness to pay for the QOL-enhancing scenarios was $60,000/QALY and did not differ by physicians' specialty or disease. CONCLUSIONS: Our findings suggest that family physicians value life-prolonging and QOL-enhancing interventions roughly equally, while oncologists value interventions that extend survival more highly than those that improve only QOL. These findings may have important implications for coverage and reimbursement decisions of new technologies.

Percutaneous augmented instrumentation of unstable thoracolumbar burst fractures.

BACKGROUND: Internal fixation of unstable thoracolumbar spine fractures requires correction of the lacking anterior column support. This usually entails insertion of a vertebral body replacement strut through an anterior approach, or a long posterior construct spanning at least two vertebrae above and two vertebrae below the fracture. Posterior short-segment pedicle instrumentation (SSPI)--one vertebra above and below--is suitable for approximately 40% of fractures, but not for all. METHODS: A total of 52 patients with unstable thoracolumbar burst fractures meeting our inclusion criteria were instrumented using a novel approach, combining percutaneous SSPI, pedicle screw augmentation with polymethyl methacrylate (PMMA) and fractured vertebra kyphoplasty. We retrospectively reviewed patient and fracture data, operative results and 1 year radiographic follow-up postoperatively in 40 of the patients. We reviewed operative complications of all 52 patients. RESULTS: Most fractures were AO/Magerl type A3.1, A3.2 and A3.3. They were instrumented within 72 h and ambulated without additional external bracing. Operative time averaged 2 h and blood loss was less than 50 cc in most cases. Complications were mostly related to PMMA leakage. On average, 3.3° (0-13) of correction was lost after 3 months, but remained constant afterward. CONCLUSIONS: Percutaneous augmented short-segment pedicle instrumentation of unstable thoracolumbar fractures can be done with short operative times, minimal blood loss and a low complication rate. The radiographical results at 1 year are equal to anterior stabilization and are better than other posterior-only techniques.

Mature Results of a Prospective Randomized Trial Comparing 5-Flourouracil with Leucovorin to 5-Flourouracil with Levamisole as Adjuvant Therapy of Stage II and III Colorectal Cancer- The Israel Cooperative Oncology Group (ICOG) Study.

OBJECTIVE: Survival benefit with adjuvant therapy was shown in patients with Stage III colorectal cancer (CRC). This study evaluates long-term (10-year) outcome in patients with CRC randomly assigned to adjuvant 5-Fluorouracil/Leucovorin (5FU+LV) or 5-FU/Levamisole (5FU+LEV). METHODS: Between 1990 and 1995, 398 patients with curatively resected Stage II-III CRC were randomly assigned to adjuvant 5FU+LV or 5FU+LEV for 12 months. RESULTS: No difference was evident in 10-year relapse-free or overall survival between study groups. Grade III toxicity was similar between groups; however, neurotoxicity was significantly greater with 5FU+LEV (p=0.02) and gastrointestinal toxicity with 5FU+LV (p=0.03). Female patients treated with 5FU+LEV had improved overall survival. CONCLUSIONS: Adjuvant treatment of CRC is still based on leucovorin modulated fluorouracil. The long-term follow-up results of this trial indicate that the adjuvant treatment of Stage II-III CRC with 5FU+LV or 5FU+LEV is equally effective. The finding of improved survival in female subjects treated with 5FU+LEV warrants further study to determine if Levamisole is a better modulator of 5-FU than Leucovorin in this patient subset.

Hard to heal pressure ulcers (stage III-IV): efficacy of injected activated macrophage suspension (AMS) as compared with standard of care (SOC) treatment controlled trial.

The objective of this study was to compare local injections of AMS with SOC treatments for stage III and IV pressure ulcers in elderly patients. It was designed as historically prospective 2-arms non-parallel open controlled trial, and conducted in a department of geriatric medicine and rehabilitation of a university affiliated tertiary hospital. We studied 100 consecutive elderly patients with a total of 216 stage III or IV pressure ulcers, 66 patients were assigned to the AMS group and had their wounds injected, while 38 patients were assigned to the SOC group. Primary outcome was rate of complete wound closure. Time to complete wound closure and 1-year mortality served as secondary outcomes. Statistical analyses were performed at both patient and wound levels. Percentage of completely closed wounds (wound level and patient level) were significantly better (p<0.001/p<0.001, respectively) in all patients in favor of AMS, as well as in the subset of diabetic patients (p<0.001/p<0.001). Similarly, AMS proved significantly better for the subset of those with leg ulcers and with baseline wounds ≤15 cm(2), compared with SOC. There were no statistically significant differences with regard to time to complete closure or 1-year mortality rates in the two groups. It is concluded that there is a significant difference in favor of stage III and IV wound closure rates by AMS, as compared with SOC treatments.