Mediating denials of pharmaceutical services: an alternative to traditional appeals.

The effectiveness of mediation as a primary tool to resolve pharmaceutical service denials by managed care is discussed. A three-month prospective randomized trial of 48 medical appeal cases involving prescription drugs was conducted by Tennessee's Department of Health. Patients whose prescription claims were denied by the state's Medicaid managed care program and whose appeals were deemed medically unnecessary by one of two independent reviewers were randomly assigned to either a standard procedure group or a mediation group. Appeals assigned to the standard procedure group were immediately referred for administrative hearing. In the mediation group, the independent reviewer assigned to the case contacted the patient's care provider, discussed the case, and recommended an alternative drug. The care provider either accepted the suggested compromise, concluding the appeals process, or declined the suggestion, allowing the appeal to go to hearing. Reviewers recorded the amount of time they spent on each appeal. The mediation did not substantially increase the time the reviewers spent on each case (mean +/- S.D. minutes, 15.83+/-7.89 mediation versus 12.26+/-6.96 standard procedure). The mean number of appealed drugs was also similar between groups (1.46+/-0.78 mediation versus 1.35+/-0.89 standard procedure). Only 21% of appealed cases went to hearings in the mediation group, while 80% did in the standard procedure group. The average cost to the state for employing mediation ($142.92+/-$186.77) was significantly lower than the average cost incurred by using standard procedures ($355.75+/-$175.43). Mediation is an effective and efficient tool for resolving patients' appeals of denied pharmaceutical services.

Laparoscopic approach to L4-L5 for interbody fusion using BAK cages: experience in the first 58 cases.

STUDY DESIGN: Operative reports were reviewed for patients who underwent laparoscopic fusion at the L4-L5 level and information regarding the mobilization of the vessels was recorded. OBJECTIVE: The purpose of this study was to describe variations in the approach used to address anatomical variations in the location of the great vessel bifurcation in the region of the L4-L5 intervertebral disc space when performing laparoscopic interbody fusion procedures. SUMMARY OF BACKGROUND DATA: Recent interest in laparoscopic spine surgery using threaded cages has resulted in questions regarding the ability to safely access the L4-L5 disc using this approach. The laparoscopic transperitoneal approach to L5-S1 is below the bifurcation of the great vessels, thus requiring minimal mobilization of the iliac vessels. However, the transperitoneal approach to L4-L5 may be complicated by the bifurcation of the great vessels anterior to this disc space. Difficulty in placing two cages may occur if the vessels cannot be adequately mobilized. METHODS: Data were collected for the consecutive series of the first 58 patients (40 males, 18 females; mean age 42.5 years) undergoing laparoscopic anterior lumbar interbody fusion (ALIF) at the L4-L5 level using BAK cages. Operative notes were reviewed to determine variations in the operative approach. In particular, it was recorded if the L4-L5 disc was accessed above, or below the bifurcation of the aorta and the vena cava, or between these structures. The blood loss, operative time, and length of hospitalization were compared with respect to approach variation. RESULTS: In 30 patients, the L4-L5 disc was accessed above the great vessel bifurcation, in 18 patients below the bifurcation, and in the remaining 10 patients, by passing between the vessels. There were no statistically significant differences in the operative time, blood loss, or length of hospitalization with respect to the approach used. Three patients were converted to open procedures as a result of bleeding from segmental veins. None required transfusions and there were no postoperative sequelae. In two patients, successful endoscopic repair of segmental vein avulsion from the vena cava was performed using endoscopic loop ligatures. One patient had a secondary procedure to remove a cage that was causingnerve irritation, and one patient reported retrograde ejaculation after a two level fusion. Another patient, in whom a posterior herniation was removed, later presented with a cerebrospinal fluid leak. Most of the operative complications occurred early in the series. CONCLUSIONS: Laparoscopic transperitoneal approach to L4-L5 for insertion of threaded fusion cages is feasible. The laparoscopic L4-L5 procedure can be accomplished with few complications, provided a dedicated team of collaborative surgeons with experience in laparoscopic spine techniques is employed. Variations in vascular anatomy did not prevent successful insertion of two threaded fusion cages.

Reoperation for herniated thoracic discs.

OBJECT: In this review the authors address the surgical strategies required to resect residual herniated thoracic discs. METHODS: Data obtained in 15 patients who had undergone prior thoracic discectomy and who harbored residual or incompletely excised symptomatic thoracic discs were reviewed retrospectively. The surgical procedures that had failed to excise the herniated discs completely included 11 posterolateral approaches, one thoracotomy, and three thoracoscopy-guided surgical procedures. Of the lesions that were incompletely resected or residual, there were 13 central calcified, two soft. 12 extradural, and three intradural discs. Indications for reoperation were often multiple in each patient and included misidentification of the level of disc disease at the initial operation (five cases), abandoning the procedure because of intraoperative spinal cord injury (three cases), inadequate visualization of the pathological entity (eight cases), migration of a soft disc fragment within the spinal canal (one case), and intradural disc extension (three cases). The symptoms at the time of reoperation included myelopathy in 13 patients and radicular pain in two patients. The mean interval before reoperation was 150 days (range 1 day-4 years). The reoperation procedures included one thoracotomy and 14 video-assisted thoracoscopic procedures performed ipsilateral (11 cases) or contralateral (four cases) to the site of the initial surgery. The herniated disc material was excised completely in all 15 cases without causing new neurological deficits. Reoperation complications included atelectasis in three patients, intercostal neuralgia in two, a loosened screw that required removal in one, residual intradural disc herniation that required a second reoperation in one patient, and a cerebrospinal fluid leak in one patient. Of the 13 patients who experienced myelopathy prior to operation, 10 recovered neurological function and three stabilized. All patients with radicular pain improved. CONCLUSIONS: Calcified, large, broad-based, centrally located, or transdural thoracic disc herniations can be difficult to resect. These lesions require a ventral operative approach to visualize the dura adequately for a safe and complete resection.

Laparoscopic fusion of the lumbar spine: minimally invasive spine surgery. A prospective multicenter study evaluating open and laparoscopic lumbar fusion.

STUDY DESIGN: Two hundred-forty consecutive patients underwent laparoscopic instrumented interbody fusion using custom-designed instrumentation and BAK (Sulzer Spine Tech, Minneapolis, MN) fusion cages. The surgeries were performed at eight spine centers during U.S. Food and Drug Administration investigational device evaluation clinical trials. This cohort was compared with 591 consecutive patients undergoing open anterior fusion with the same device. OBJECTIVES: To investigate the feasibility and safety of the laparoscopic approach compared with that of open procedures. SUMMARY OF BACKGROUND DATA: In other areas of medicine, advances in laparoscopic surgical procedures have resulted in reduced morbidity, expense, and pain when compared with results of the open counterpart. METHODS: The open anterior procedure was performed using a retroperitoneal approach. The laparoscopic procedure was performed transperitoneally with carbon dioxide insufflation to provide visualization using a 10-mm endoscope. Two hollow, titanium, threaded interbody implants packed with autologous bone were inserted into the diseased interspace. RESULTS: The laparoscopy group had a shorter hospital stay and reduced blood loss but had increased operative time. Operative time improved in the laparoscopy group as surgeons' experience increased. Operative complications were comparable in both groups, with an occurrence of 4.2% in the open approach and 4.9% in the laparoscopic approach. Overall, the device-related reoperation rate was higher in the laparoscopy group (4.7% vs. 2.3%), primarily as a result of intraoperative disc herniation. Conversion to open procedure in the laparoscopy group was 10%, with most cases predictable and preventable. CONCLUSIONS: The laparoscopic procedure is associated with a learning curve, but once mastered, it is effective and safe when compared with open techniques of fusion.

Video-assisted thoracoscopic excision of herniated thoracic disc: description of technique and preliminary experience in the first 29 cases.

This study evaluates the technique and results of video-assisted thoracoscopic surgery (VATS) for the treatment of symptomatic thoracic disc herniation. Results were compared with a literature review of open surgical techniques of thoracic disc excision with regard to efficacy, safety, and surgical outcomes. VATS has recently been described for thoracic surgery as having the advantage of decreased postoperative pain and morbidity, faster patient recovery, and shortened intensive care unit (ICU) hospitalization. Twenty-nine consecutive patients underwent VATS for symptomatic thoracic disc herniation. Herniations ranging from T5-6 to T12-L1 were successfully approached by using a three- or four-portal strategy. Postoperative magnetic resonance imaging (MRI) scans were evaluated. Pre- and postoperative Oswestry Disability Questionnaires and Linear Analog Pain Scale data were obtained. Patients were grouped according to presenting symptoms. The minimal follow-up was 1 year (range, 12-24 months). Mean operative time was 175 min for 29 patients. Significant improvement (p < 0.01, paired t test) was recorded in Oswestry Disability Questionnaires and Linear Analog Scale Tests. Of the patients, 75.8% (22) were satisfied, 3.4% (one) unsatisfied, with 20.1% (six) unchanged. Narcotic use was significantly eliminated or reduced. Mean return to work was 5 weeks (private insurance) and 21 weeks (workers compensation). The surgical and postoperative complication rate was 13.8%. VATS appears to be a safe and efficacious method of excising herniated thoracic discs. Follow-up results at 1 year resulted in high patient satisfaction. VATS advantages include decreased length of hospitalization as well as improved patient comfort.

Minimally invasive anterior retroperitoneal approach to the lumbar spine. Emphasis on the lateral BAK.

STUDY DESIGN: Eighteen patients with lumbar instability from fractures, postlaminectomy syndrome, or infection were treated prospectively with minimally invasive retroperitoneal lumbar fusions. OBJECTIVES: To determine if interbody Bagby and Kuslich fusion cages and femoral allograft bone dowels can be inserted in a transverse direction via a lateral endoscopic retroperitoneal approach to achieve spinal stability. SUMMARY OF BACKGROUND DATA: Endoscopic spinal approaches have been used to achieve lower lumbar fusion when instrumentation is placed through a laparoscopic, transperitoneal route. However, complications of using this approach include postoperative intra-abdominal adhesions, retrograde ejaculation, great vessel injury, and implant migration. This study is the first clinical series investigating the use of the lateral retroperitoneal minimally invasive approach for lumbar fusions from L1 to L5. METHODS: Eighteen patients underwent anterior interbody decompression and/or stabilization via endoscopic retroperitoneal approaches. In most cases, three 12-mm portals were used. Two parallel transverse interbody cages restored the neuroforaminal height and the desired amount of lumbar lordosis was achieved by inserting a larger anterior cage, distraction plug, or bone dowel. RESULTS: The overall morbidity of the procedure was lower than that associated with traditional "open" retroperitoneal or laparotomy techniques, with a mean length of hospital stay of 2.9 days (range, outpatient procedure to 5 days). The mean estimated intraoperative blood loss was 205 cc (range, 25-1000 cc). There were no cases of implant migration, significant subsidence, or pseudoarthrosis at mean follow-up examination of 24.3 months (range, 12-40 months) after surgery. CONCLUSIONS: This preliminary study of 18 patients illustrates that endoscopic techniques can be applied effectively through a retroperitoneal approach with the patient in the lateral position. Unlike the patients who had undergone transperitoneal procedures described in previous reports, in these preliminary 18 patients, there were no cases of retrograde ejaculation, injury to the great vessels, or implant migration.

Pathways for electron tunneling in cytochrome c oxidase.

Warburg showed in 1929 that the photochemical action spectrum for CO dissociation from cytochrome c oxidase is that of a heme protein. Keilin had shown that cytochrome a does not react with oxygen, so he did not accept Warburg's view until 1939, when he discovered cytochrome a3. The dinuclear cytochrome a3-CuB unit was found by EPR in 1967, whereas the dinuclear nature of the CuA site was not universally accepted until oxidase crystal structures were published in 1995. There are negative redox interactions between cytochrome a and the other redox sites in the oxidase, so that the reduction potential of a particular site depends on the redox states of the other sites. Calculated electron-tunneling pathways for internal electron transfer in the oxidase indicate that the coupling-limited rates are 9 x 10(5) (CuA-->a) and 7 x 10(6) s(-1) (a-->a3); these calculations are in reasonable agreement with experimental rates, after corrections are made for driving force and reorganization energy. The best CuA-a pathway starts from the ligand His204 and not from the bridging sulfur of Cys196, and an efficient a-a3 path involves the heme ligands His378 and His376 as well as the intervening Phe377 residue. All direct paths from CuA to a3 are poor, indicating that direct CuA-->a3 electron transfer is much slower than the CuA-->a reaction. The pathways model suggests a means for gating the electron flow in redox-linked proton pumps.

Endoscopic techniques in spinal surgery.

Minimally invasive techniques are becoming more widespread in the surgical subspecialties. Standard open surgical procedures are being modified to become less invasive, with the hopes of decreased recovery time, lessened morbidity, and ultimately, cost savings. Improvements in technology have allowed the surgeon to peer into body cavities and create potential spaces such as the retroperitoneum and the neuroforaminal space without the need for traditional extensile surgical approach. Improved fiberoptics, light sources, and the advent of the 3-chip camera and the 3-dimensional camera have resulted in improvements in visualization of the structures surrounding the spine. Although the goals of endoscopic surgery are to maintain or improve visualization and minimize the approach related trauma, procedures must also prove efficacious and safe with at least equivalent results compared with their open surgical counterpart. Not all procedures may be applicable to minimally invasive approaches and just because a procedure can be done does not mean that it should be done. Laparoscopic and thoracoscopic spine procedures also depend on the partnership of the spine surgeon with the thoracic or general surgeon with endoscopic experience to ensure patient safety. Proficiency in minimally invasive spinal techniques takes devotion and does not occur after taking minicourses. Practice with cadaver and in vivo models, preceptorship and proctorship training, and ultimately the teaching of these techniques in residency and spinal fellowship programs will undoubtedly lead to favorable outcomes and reduced medical expenditure. Preliminary results are encouraging for endoscopic spinal surgery, but further testing of these new techniques against conventional open procedures will be important in documenting not only the efficacy of the procedure, but also its value in patient satisfaction and cost.

Laparoscopic fusion of the lumbar spine in a multicenter series of the first 34 consecutive patients.

The purpose of this study was to describe the development of the laparoscopic technique for anterior lumbar fusion and to evaluate the clinical results of a first case series of patients. The in vivo porcine model was used first to develop the technique of transperitoneal laparoscopic interbody fusion. Afterwards, operative time, blood loss, perioperative complications and length of stay were recorded for the first 34 patients who underwent laparoscopic fusion of L4-5 or L5-S1 at two medical centers in 1994. Laparoscopic lumbar fusion was successful in 30 of 34 patients. Four patients early in the series successfully were converted to an open procedure because of poor visualization (two cases) or iliac venous injury (two cases). Transfusion was required in one patient; average blood loss was 128 ml. Operative time averaged 218 min, hospitalization 3.67 days. Laparoscopic fusion is feasible and has minimal complications when a skilled laparoscopic surgeon is present for exposure. Minimal excisional trauma associated with this technique should result in decreased hospitalization and earlier recovery compared with standard open techniques. Preliminary results indicate an earlier discharge and return to work (3 weeks) than that expected for standard open techniques.

Percutaneous endoscopic thoracic discectomy.

Video-assisted thoracic surgery (VATS) appears to be a safe and efficacious method of excising herniated thoracic discs. Results indicate high patient satisfaction rates comparable to those of open thoracotomy. VATS' advantages include decreased length of hospitalization, decreased postoperative pain, less shoulder girdle dysfunction, lower incidence of pulmonary complications and post-thoracotomy syndrome, and earlier return to normal activity when compared to thoracotomy approaches.

Electron tunneling in azurin: the coupling across a beta-sheet.

BACKGROUND: We would like to understand how electron flow is controlled in biological molecules. Standard theories calculate the rate for long distance electron transfer (ET) as the product of electronic coupling (the square of the electron tunneling matrix element) and nuclear (Franck-Condon) factors. Much attention has been directed to the role of protein secondary and tertiary structure in the tunneling coupling, focusing on the interplay between different types of chemical bonds. Here we have evaluated the relative contributions of covalent bonds, hydrogen bonds and through-space jumps in coupling through a beta-strand or across a beta-sheet section of a blue copper protein, azurin. RESULTS: We have analyzed four distant electronic couplings in azurin. Each coupling is between the copper atom and a Ru(bpy)2(im) complex attached to a histidine on the protein surface. In three experiments the intervening medium was a simple beta-strand, while in the fourth experiment it was a section of beta-sheet. CONCLUSIONS: We have shown that electron tunneling in a protein can be broken down into ET 'tubes' of pathways through specific covalent and hydrogen bonds. These ET tubes encapsulate trivial interference effects and can expose crucial inter-tube interference effects. In coupling through a beta-sheet, hydrogen bonds are as important as covalent links, and are the primary source for tube interference.

Pathways, pathway tubes, pathway docking, and propagators in electron transfer proteins.

The simplest views of long-range electron transfer utilize flat one-dimensional barrier tunneling models, neglecting structural details of the protein medium. The pathway model of protein electron transfer reintroduces structure by distinguishing between covalent bonds, hydrogen bonds, and van der Waals contacts. These three kinds of interactions in a tunneling pathway each have distinctive decay factors associated with them. The distribution and arrangement of these bonded and nonbonded contacts in a folded protein varies tremendously between structures, adding a richness to the tunneling problem that is absent in simpler views. We review the pathway model and the predictions that it makes for protein electron transfer rates in small proteins, docked proteins, and the photosynthetic reactions center. We also review the formulation of the protein electron transfer problem as an effective two-level system. New multi-pathway approaches and improved electronic Hamiltonians are described briefly as well.

Video-assisted thoracic surgery for the anterior approach to the thoracic spine.

Standard anterior approach to the thoracic spine is by a posterolateral thoracotomy. Because of the morbidity associated with this incision, video-assisted thoracic surgery (VATS) has been used as a less invasive approach for many intrathoracic disease processes. We have applied VATS for anterior access to the thoracic spine. From April 1991 to September 1994, 95 patients underwent thoracic spine procedures using thoracoscopy as the sole method of anterior approach. Procedures performed include discectomy for herniation (n = 57), multilevel discectomy for correction of spinal deformity (27), corpectomy (9), and drainage of intervertebral disc space abscess (2). All levels of the thoracic spine from the T2-T3 level to the T12-L1 interspace were approached. Forty-four procedures were performed through the left side of the chest and 41 through the right. The planned procedure was accomplished by VATS in all but 1 patient who required conversion to an open procedure because of scarring from a previous spine procedure. Mean operative time was 2 hours 24 minutes (range, 45 minutes to 5 hours 10 minutes). Average chest tube duration was 1.4 days, and mean length of stay was 4.82 days (range, 2 to 21 days). Complications included intercostal neuralgia (6), atelectasis (5), excessive epidural blood loss (2,500 mL; 2) and temporary paraparesis in a scoliosis patient related to operative positioning. We conclude that VATS offers a new, less morbid anterior approach to the thoracic spine. Although there is a significant learning period, most procedures requiring an anterior access can be performed safely by this technique. The VATS approach mandates an expanded role for the thoracic surgeon in operative spine disease.

A technical report on video-assisted thoracoscopy in thoracic spinal surgery. Preliminary description.

STUDY DESIGN: This report is a preliminary description of the efficacy of video-assisted thoracoscopic surgery in thoracic spinal procedures that otherwise require open thoracotomy. OBJECTIVE: This report sought to describe the efficacy of video-assisted thoracoscopic surgery in thoracic spinal procedures that otherwise require open thoracotomy. SUMMARY OF BACKGROUND DATA: In a landmark study that compared video-assisted thoracoscopic surgery for peripheral lung lesions with thoracotomy, video-assisted thoracoscopic surgery reduced postoperative pain, improved early shoulder girdle function, and shortened hospital stay. METHODS: Video-assisted thoracoscopic surgery was performed in 12 thoracic spinal patients (herniated nucleus pulposus, infection, tumor, or spinal deformity) and is described in detail in this report. RESULTS: Video-assisted thoracoscopic surgery in thoracic spinal surgery resulted in little postoperative pain, short intensive care unit and hospital stays, and little or no morbidity. In the short follow-up period, there was no post-thoracotomy pain syndrome nor neurologic sequelae in these patients. Operative time decreased dramatically as experience was gained with the procedure. CONCLUSION: Given consistently improving surgical skills, a number of thoracic spinal procedures using video-assisted thoracoscopic surgery, including thoracic discectomy, internal rib thoracoplasty, anterior osteotomy, corpectomy, and fusion, can be performed safely with no additional surgical time or risk to the patient.

Application of thoracoscopy for diseases of the spine.

For anterior approaches to the thoracic spine, a posterolateral thoracotomy has been the standard approach. Recent expanded experience with video-assisted thoracic surgical techniques has allowed us to perform many thoracic spine procedures that previously required open approaches. These procedures include drainage of spinal abscesses, biopsy of vertebral bodies, discectomy for a herniated nucleus pulposus, and anterior releases for kyphoscoliosis. All procedures were successful, but experience is limited and follow-up still short. It is hoped that further experience will prove that this less invasive approach can be widely applied in the practice of thoracic spinal surgery.

The Tridimensional Personality Questionnaire in major depression.

The authors examined Tridimensional Personality Questionnaire scores in 40 patients with unipolar nonpsychotic major depression before and after antidepressant treatment. They found that scores on the novelty seeking and reward dependence dimensions were not affected by depressed state or by treatment response status. However, scores on the harm avoidance dimension were significantly lower in antidepressant responders and were altered by depressed state.

Clinical features of situational and nonsituational major depression.

Clinical lore has long supported the subtype of situational or reactive depression. To date, however, there has been limited empirical research support for this subtype of major depression. We examined demographic, clinical and personality features of situational and nonsituational depression in 89 outpatients with unipolar nonpsychotic major depressive disorder. Situational depressives had a less recurrent course of illness and appeared to respond more completely to the antidepressant used for their current episode. Demographic and personality measures did not distinguish situational and nonsituational depression.

The effect of sensory deprivation in the reduction of pain in patients with chronic low-back pain.

Patients who suffer from persistent pain for prolonged periods of time (6 months or more) are often influenced to an increasing extent by psychological factors. Patients begin to focus on their pain as the problem rather than its physical origin. This study evaluated the effectiveness of sensory deprivation in reducing pain in patients with chronic low-back pain. Sixty patients were divided into two groups of 30 patients each: One group underwent 1 hour of sensory deprivation; the other received a lecture on relaxation skills. In the group receiving sensory deprivation, statistically significant decreases in pain and stiffness were noted. Sensory deprivation is an effective treatment to reduce pain and thus interrupt the pain cycle in patients with chronic low-back pain.