Multicenter Study

Randomized, double-blind, sequential, multicenter clinical trial of two doses of Sygen versus placebo. To determine efficacy and safety of Sygen in acute spinal cord injury. An earlier, single-center trial in 28 patients showed an improvement (50.0% vs. 7.1%, P = 0.034) in marked recovery with Sygen. Standard clinical trial techniques. The prospectively planned analysis at the prespecified endpoint time for all patients was negative. There was a significant effect in all patients in the primary outcome variable (the percentage of marked recovery) at week 8, the end of the dosing period. There was a significant effect in all patients in the time at which marked recovery is first achieved. Restricted to severity Group B, which has small sample size, the primary efficacy analysis showed a trend but did not reach significance. There is a large, consistent and, at some time points, significant effect in the primary outcome variable in the nonoperated patients through week 26. The American Spinal Injury Association motor, light touch, and pinprick scores showed a consistent trend in favor of Sygen, as also did bowel function, bladder function, sacral sensation, and anal contraction. The less severely injured patients appeared to have a greater beneficial drug effect. Evidence against an effect of Sygen was minimal and scattered. Although not proven in the primary efficacy analysis of this trial, Sygen appears to be beneficial in patients with severe spinal cord injury.

Multicenter research is an effective paradigm for biomedical research and offers advantages such as large sample size, cost-effectiveness and enhances external validity. Concurrently, multicenter research may raise various ethical and practical concerns since practices vary across involved research centers primarily due to varied local laws and available technology. Although, there is a widespread debate about the ethical considerations for a multicenter research, yet limited literature exists on this topic. The main purpose of this paper is to review and summarize the existent literature on the topic of ethical considerations for multicenter research. Our search and review of the existent literature revealed that in general the main ethical considerations for a multicenter research are 1) ethics board review process, 2) informed consent process, 3) protection of confidentiality and vulnerability 4) data monitoring and 5) best practices. This paper concludes that each multicenter research situation is unique, so “one size fits all” approach is not possible to be prescriptive in how to conduct an ethically sound multicenter research. However, it is recommended to foster partnerships and have open communications among the involved researchers and ethics review boards to gain a clear understanding beforehand about the context specific and ambiguous local situations and issues to design and conduct an effective multicenter research.

Arthrodesis is the gold standard for surgical treatment of lumbar degenerative disc disease (DDD). Solid fusion, however, can cause stress and increased motion in the segments adjacent to the fused level. This may initiate and/or accelerate the adjacent-segment disease process. Artificial discs are designed to restore and maintain normal motion of the lumbar intervertebral segment. Restoring and maintaining normal motion of the segment reduces stresses and loads on adjacent level segments. A US Food and Drug Administration Investigational Device Exemptions multicentered study of the Charité artificial disc was completed. The control group consisted of individuals who underwent anterior lumbar interbody fusion involving BAK cages and iliac crest bone graft. This is the first report of Class I data in which a lumbar artificial disc is compared with lumbar fusion. Of 304 individuals enrolled in the study, 205 were randomized to the Charité disc-treated group and 99 to the BAK fusion-treated (control) group. Neurological status was equivalent between the two groups at 6, 12, and 24 months postoperatively. The number of patients with major, minor, or other neurological complications was equivalent. There was a greater incidence of both major and minor complications in the BAK fusion group at 0 to 42 days postoperatively. Compared with data reported in the lumbar fusion literature, the Charité disc-treated patients had equivalent or better mean changes in visual analog scale and Oswestry Disability Index scores. The Charité artificial disc is safe and effective for the treatment of single-level lumbar DDD, resulting in no higher incidence of neurological complications compared with BAK-assisted fusion and leading to equivalent or better outcomes compared with those obtained in the control group and those reported in the lumbar fusion literature.

Study Design. A prospective, randomized, multicenter, FDA-regulated Investigational Device Exemption clinical trial.
Objectives. To analyze the incidence of, and reasons for, reoperation in all patients (treatment and control) enrolled in the IDE study.
Summary of Background Data. This is the first report of the incidence and nature of reoperations following lumbar TDR as part of a controlled, prospective, multi-center trial.
Methods. A total of 688 patients meeting the inclusion and exclusion criteria were enrolled in one of three arms of the study at 14 centers across the United States. This cohort includes 71 nonrandomized cases, 205 randomized cases, and 313 continued access cases, all receiving the CHARITE Artificial Disc, as well as 99 randomized cases in the control group (ALIF with threaded fusion cages and autograft). A detailed analysis was performed of clinical chart notes, operative notes, and adverse event reports for all patients requiring reoperation following their index surgery.
Results. Of the 589 patients with TDR, 52 (8.8%) required reoperation. Of the 99 patients with lumbar fusion, 10 (10.1%) required reoperation, and an additional 2 required surgery for adjacent level disease (P=0.7401). There were 24 TDR patients who underwent a repeated anterior retroperitoneal approach, with 22 (91.7%) having had a successful removal of the prosthesis. Seven of the 24 TDR prostheses requiring removal were revised to another CHARITE Artificial Disc. The mean time to re-operation in all patients was 9.7 months. A total of 29 patients (4.9%) in the TDR group required posterior instrumentation and fusion as did 10 (10.1%) in the control group (P=0.0562). At 2 years or more follow-up, 93.9%

IMPORTANCE Optimizing radiation therapy techniques for localized prostate cancer can affect patient outcomes. Dose escalation improves biochemical control, but no prior trials were powered to detect overall survival (OS) differences. OBJECTIVE To determine whether radiation dose escalation to 79.2 Gy compared with 70.2 Gy would improve OS and other outcomes in prostate cancer.

Introduction: oral cancer is a leading cause of cancer deaths among African populations. Lack of standard cancer registries and under-reporting has inaccurately depicted its magnitude in Nigeria. Development of multi-centre collaborative oral pathology networks such as the African Oral Pathology Research Consortium (AOPRC) facilitates skill and expertise exchange and fosters a robust and systematic investigation of oral diseases across Africa.
Methods: in this descriptive cross-sectional study, we have leveraged the auspices of the AOPRC to examine the burden of oral cancer in Nigeria, using a multi-centre approach. Data from 4 major tertiary health institutions in Western and Southern Nigeria was generated using a standardized data extraction format and analysed using the SPSS data analysis software (version 20.0; SPSS Inc. Chicago, IL).
Results: of the 162 cases examined across the 4 centres, we observed that oral squamous cell carcinomas (OSCC) occurred mostly in the 6th and 7th decades of life and maxillary were more frequent than mandibular OSCC lesions. Regional variations were observed both for location, age group and gender distribution. Significant regional differences was found between poorly, moderately and well differentiated OSCC (p value = 0.0071).
Conclusion: a multi-centre collaborative oral pathology research approach is an effective way to achieve better insight into the patterns and distribution of various oral diseases in men of African descent. The wider outlook for AOPRC is to employ similar approaches to drive intensive oral pathology research targeted at addressing the current morbidity and mortality of various oral diseases across Africa.

End-of-life interventions should be predicated on consensus understanding of patient wishes. Written documents are not always understood; adding a video testimonial/message (VM) might improve clarity. Goals of this study were to (1) determine baseline rates of consensus in assigning code status and resuscitation decisions in critically ill scenarios and (2) determine whether adding a VM increases consensus. We randomly assigned 2 web-based survey links to 1366 faculty and resident physicians at institutions with graduate medical education programs in emergency medicine, family practice, and internal medicine. Each survey asked for code status interpretation of stand-alone Physician Orders for Life-Sustaining Treatment (POLST) and living will (LW) documents in 9 scenarios. Respondents assigned code status and resuscitation decisions to each scenario. For 1 of 2 surveys, a VM was included to help clarify patient wishes. Response rate was 54%, and most were male emergency physicians wh...

Purpose: The purpose of the Listening and Spoken Language
Data Repository (LSL-DR) was to address a critical need
for a systemwide outcome data–monitoring program
for the development of listening and spoken language
skills in highly specialized educational programs for
children with hearing loss highlighted in Goal 3b of the
2007 Joint Committee on Infant Hearing position statement
supplement.

Method: The LSL-DR is a multicenter, international data
repository for recording and tracking the demographics and
longitudinal outcomes achieved by children who have hearing
loss who are enrolled in private, specialized programs
focused on supporting listening and spoken language
development. Since 2010, annual speech-language-hearing
outcomes have been prospectively obtained by qualified
clinicians and teachers across 48 programs in 4 countries.

Results: The LSL-DR has been successfully implemented,
bringing together the data collection efforts of these
programs to create a large and diverse data repository of
5,748 children with hearing loss.

Conclusion: Due to the size and diversity of the population,
the range of assessments entered, and the demographic
information collected, the LSL-DR will provide an unparalleled
opportunity to examine the factors that influence the
development of listening in spoken language in this
population.

3-Methylglutaconic aciduria, dystonia-deafness, hepatopathy, encephalopathy, Leigh-like syndrome (MEGDHEL) syndrome is caused by biallelic variants in SERAC1. This multicenter study addressed the course of disease for each organ system. Metabolic, neuroradiological, and genetic findings are reported. Sixty-seven individuals (39 previously unreported) from 59 families were included (age range = 5 days-33.4 years, median age = 9 years). A total of 41 different SERAC1 variants were identified, including 20 that have not been reported before. With the exception of 2 families with a milder phenotype, all affected individuals showed a strikingly homogeneous phenotype and time course. Severe, reversible neonatal liver dysfunction and hypoglycemia were seen in >40% of all cases. Starting at a median age of 6 months, muscular hypotonia (91%) was seen, followed by progressive spasticity (82%, median onset = 15 months) and dystonia (82%, 18 months). The majority of affected individuals neve...

End-of-life interventions should be predicated on consensus understanding of patient wishes. Written documents are not always understood; adding a video testimonial/message (VM) might improve clarity. Goals of this study were to (1) determine baseline rates of consensus in assigning code status and resuscitation decisions in critically ill scenarios and (2) determine whether adding a VM increases consensus. We randomly assigned 2 web-based survey links to 1366 faculty and resident physicians at institutions with graduate medical education programs in emergency medicine, family practice, and internal medicine. Each survey asked for code status interpretation of stand-alone Physician Orders for Life-Sustaining Treatment (POLST) and living will (LW) documents in 9 scenarios. Respondents assigned code status and resuscitation decisions to each scenario. For 1 of 2 surveys, a VM was included to help clarify patient wishes. Response rate was 54%, and most were male emergency physicians wh...

OBJECTIVES To determine the incidence, risk factors, signs, symptoms and management of perioperative allergic reactions in the Thai Anesthesia Incidents Study (THAI Study). MATERIAL AND METHOD Between February 1, 2003, and January 31, 2004, a descriptive, prospective, multicenter study was conducted in 20 hospitals across Thailand. All patients receiving anesthetic and medical agents were monitored for allergic reactions for the first 24 postoperative-hours. Signs and symptoms of suspected allergic reactions included skin reactions, wheezing and unexpected hypotension. The details of allergic reactions were reviewed and recorded. RESULTS Allergic reactions occurred in 30 of the 163,403 patients included in this study. The reaction-incidence was approximately 1 in 5,500 cases of anesthesia. Forty-eight percent of the affected patients had a history of allergic reactions. The manifestations were skin reactions, hypotension and wheezing in 38, 22 and 19 percent of the overall symptoms,...

Background/Objectives: To evaluate the relationship between the severity of cervical spinal cord injury (SCI) (American Spinal Injury Association [ASIA] grade), presence of neurogenic shock, and timing of surgical intervention. This is a post-hoc analysis from the Sygen multicenter randomized controlled trial. Methods: Blood pressure (BP) and heart rate (HR) data were collected when patients were first assessed in the emergency room (Time A) and at the time of randomization (Time B). Individuals were subdivided by ASIA grade and by the level of the systolic BP (SBP). Results: Only individuals with cervical SCI from the Sygen trial (n ¼ 577) were evaluated. Severe complete SCI (ASIA grade ¼ A) was established in 57% of these patients. A total o f 74 (13%) patients with neurogenic shock (SBP , 90 mmHg) at Time A were identified. The SBP increased significantly from Time A to Time B (P , 0.0001). The median time from SCI to surgical intervention, for ASIA A, was 80.9 hours for patients with initial SBP , 90 mmHg and 58 hours for patients with initial SBP ! 90 mmHg (P ¼ 0.025). Multivariable analysis after adjusting for confounders revealed a statistically significant difference in the time to surgical intervention based on SBP for ASIA A (P ¼ 0.026), yet not for ASIA B or C/D. Conclusions: The presence of neurogenic shock was associated with a delay in the timing of surgical intervention in patients with cervical SCI. Detailed evaluation of autonomic dysfunctions following SCI including cardiovascular instability could improve our understanding of the complexities of clinical presentations and possible neurological outcomes.

Background. Sex differences in cognitive functioning have long been recognized in schizophrenia patients and healthy controls (HC). However, few studies have focused on patients with an at-risk mental state (ARMS) for psychosis. Thus, the aim of the present study was to investigate sex differences in neurocognitive performance in ARMS patients compared with HC. Methods. The data analyzed in this study were collected within the multicenter European Gene–Environment Interactions study (11 centers). A total of 343 ARMS patients (158 women) and 67 HC subjects (33 women) were included. All participants completed a comprehensive neurocognitive battery. Linear mixed effects models were used to explore whether sex differences in cognitive functioning were present in the total group (main effect of sex) and whether sex differences were different for HC and ARMS (interaction between sex and group). Results. Women performed better in social cognition, speed of processing, and verbal learning t...

Background
Ameloblastoma is a locally aggressive odontogenic tumour (OT) that arises from odontogenic epithelium without neoplastic involvement of odontogenic ectomesenchyme. It is the commonest OT in developing countries, especially in Africa, and, hence, a clinically significant lesion among Africans. It has been suggested that the biologic behaviour of ameloblastoma in black Africans is different from the other populations. The high incidence of ameloblastoma in Africans warrants further evidence-based research.

Method
In this descriptive cross-sectional study, AOPRC employed a multi-centre approach to retrieve archival demographic and clinicopathological data on ameloblastoma from five major tertiary health institutions in South–West and South–South regions of Nigeria. Data were generated using a standardized data extraction format and analysed using Epi-info (version 7.0).

Result
From the five centres, a total of 566 cases met our study criteria. We observed that there was a slight male preponderance on ameloblastoma among the cases studies. For all types of ameloblastoma, mandibular lesions were found more frequently than maxillary ones. Most patients presented within 1–5 years of onset of jaw swelling (45.94%). There was a statistically significant higher mean duration for unicystic variants as compared to multi-cystic ameloblastoma (p = 0.0215). Overall, we also observed that the plexiform variants were the most frequently occurring and that the acanthomatous variant was significantly more common in females than males (p = 0.01).

Conclusion
The current study serves as primer and justification for the application of emerging novel molecular techniques to understand the pathobiology and basis for clinic-pathological disparity of ameloblastoma among men of African descent.

"The final publication is available at link.springer.com”.

Prospective, multicenter, randomized clinical trial. To evaluate the long-term safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in treatment of patients with symptomatic single-level degenerative spondylosis between C3-C4 and C7-T1 with or without prior cervical fusion. The 2-year results of the PCM Cervical Disc trial have been reported previously. The current study reports the long-term results of the same trial. Patients with single-level cervical spondylosis and radiculopathy with or without myelopathy unresponsive to nonoperative treatment were enrolled. The per protocol patient sample at 5 years included 293 patients (163 PCM, 130 ACDF). Adverse events and secondary surgical procedures are reported on the cohorts through current follow-up, which include 110 patients (68 PCM, 42 ACDF) at 7 years. At 5 years postoperative, all patient-reported outcomes-neck and arm pain visual analogue scale score, neck disability index, and general health (36-Item Short Form Health Survey physical and mental component scores: physical component summary, mental component summary)-were significantly improved from baselines in both groups, and mean scores were significantly better in the PCM group for neck disability index (P = 0.001), neck pain (P = 0.002), general health (Pphysical component summary= 0.014; Pmental component summary= 0.004), and patient satisfaction (P = 0.005). PCM patients trended toward fewer 2- to 7-year device-related serious adverse events (1/214, 0.5% PCM; 2/190, 1.1% ACDF) and secondary surgical procedures (7/211, 3.3% PCM; 14/290, 7.6% ACDF). Adjacent-level degeneration was radiographically more frequent after ACDF (33.1% PCM, 50.9% ACDF; P = 0.006) and was the primary indication for the increase in late-term secondary surgical procedures after ACDF. The long-term results show good clinical outcomes after ACDF and PCM arthroplasty. PCM patients showed greater improvement in neck disability index and neck pain scores with a lower rate of radiographical adjacent-level degeneration and a trend toward fewer secondary surgical procedures. These data support PCM arthroplasty to be a viable and sustainable alternative to ACDF.

Object. Arthrodesis is the gold standard for surgical treatment of lumbar degenerative disc disease (DDD). Solid fusion, however, can cause stress and increased motion in the segments adjacent to the fused level. This may initiate and/or accelerate the adjacent-segment disease process. Artificial discs are designed to restore and maintain normal motion of the lumbar intervertebral segment. Restoring and maintaining normal motion of the segment reduces stresses and loads on adjacent level segments. A US Food and Drug Administration Investigational Device Exemptions multi-centered study of the Charité artificial disc was completed. The control group consist- ed of individuals who underwent anterior lumbar interbody fusion involving BAK cages and iliac crest bone graft. This is the first report of Class I data in which a lumbar artificial disc is compared with lumbar fusion. Methods. Of 304 individuals enrolled in the study, 205 were randomized to the Charité disc-treated group and 99 to the BAK fusion– treated (control) group. Neurological status was equivalent between the two groups at 6, 12, and 24 months post-operatively. The number of patients with major, minor, or other neurological complications was equivalent. There was a greater incidence of both major and minor complications in the BAK fusion group at 0 to 42 days postoperative- ly. Compared with data reported in the lumbar fusion literature, the Charité disc–treated patients had equivalent or better mean changes in visual analog scale and Oswestry Disability Index scores. Conclusions. The Charité artificial disc is safe and effective for the treatment of single-level lumbar DDD, resulting in no higher incidence of neurological complications compared with BAK-as- sisted fusion and leading to equivalent or better outcomes compared with those obtained in the control group and those reported in the lumbar fusion literature.

The MightyMedic (Multidisciplinary International Group for Hemapheresis TherapY and MEtabolic DIsturbances Contrast) Working Group has been founded in 2013. The leading idea was to establish an international network of interdisciplinary nature aimed at working to cross national borders research projects, clinical trials, educational initiatives (meetings, workshops, summer schools) in the field of metabolic diseases, namely hyperlipidemias, and diabetes, preventive cardiology, and atherosclerosis. Therapeutic apheresis, its indications and techniques, is a parallel field of investigation. The first on-line survey of the Group has been completed in the first half of 2014. The survey included # 24 Centers in Italy, Germany, Greece, UK, Sweden, Japan and USA. Relevant data have been collected on current practice in diagnosis, therapy and follow-up of dyslipidemias. 240 subjects with hyperlipidemia and treated with lipoprotein apheresis have been reported in the survey, but a large perc...

The ability of health researchers to unearth previously unsuspected health risks, trends and commonalities at a population level through matching information across different datasets is well attested. However, as more of this type of research is conducted, the spotlight is being shone on the barriers to accessing these data. Less well known are the complexities experienced by researchers working with datasets in an Aboriginal and Torres Strait Islander health context. We present the insights of a number of researchers, clinicians and public sector representatives who have extensive experience of data linkage in the Aboriginal and Torres Strait Islander health sector, on key issues and practical and ethical implications of utilising big datasets. Obstacles are further highlighted in the experiences of a national multicentre cancer cervical screening study. While researchers must at all times respect the individuals whose information is contained within these datasets, and abide by t...

BACKGROUND AND RATIONALE Since anesthesia, unlike medical or surgical specialties, does not constitute treatment, The Royal College of Anesthesiologists of Thailand host the Thai Anesthesia Incidents Study (THAI Study) of anesthetic outcomes to determine factors related to anesthesia related adverse events. MATERIAL AND METHOD A prospective descriptive study of occurrence screening was conducted in 20 hospitals comprised of 7 university, 4 general and 4 district hospitals across Thailand. Anesthesia personnels were required to fill up patient-related, surgical-related, anesthesia-related variables and adverse outcomes on a strutured data entry form. The data included preanesthetic evaluation intraoperative period and 24 hr postoperative period. Adverse events specific form was recorded when adverse events occurred. All data were keyed in data management unit with double entry technique and descriptive statistics was used in the first phase of this study. RESULTS A total of 163403 co...

Abstract Social skills occurring in a high frequency and low variability can be taken as patterns, suggesting cultural or sub-cultural features which are important when selecting instruments for evaluation and planning interventions. This research aimed to characterize the social skills repertoire among Psychology students from 4 Brazilian places: São Paulo (SP), Bahia (BA), Minas Gerais (MG)e Rio de Janeiro (RJ), also examining their differences and the influence of sex and age on their patterns. Five hundred sixty four Psychology undergraduates completed a self-report inventory (IHS-del-Prette) with a structure of 5 factors: F1) coping and assertion; F2) expressing positive affection; F3) talking and self-confidence; F4) dealing with unknown people and new situations; F5) aggressiveness self-control. The samples were compared considering general (GS) and factorial (F1, F2, F3, F4 e F5) scores as well as sex and age influence in each one (ANOVA, followed by t or Scheffé test). The results showed that: a) Psychology students presented higher scores than normative sample in the GS, F1, F3 and F4 and lower in the F2 and F5, but sex differences were similar to the normative pattern; b) place, sex and age significantly affected the scores, with place-sex and place-age interactions; c) samples from MG, BA, RJ and SP presented similar profiles, with higher values for RJ in the F1 and for MG and SP in the F2 and F5; d) students from BA presented the highest sex differences and from RJ the lowest ones; e) age differences occurred in the F4 (favorable to younger students for SP) and in the F5 (favorable to older ones for BA and RJ). The meaning of these differences and similarities are discussed as well as some explanatory hypotheses and questions for further studies.

Resumo Habilidades sociais que ocorrem com alta freqüência e pouca variabilidade podem ser consideradas como padrões, sugerindo características da cultura ou subcultura que são importantes na seleção de instrumentos de avaliação e no planejamento de intervenções. Este trabalho buscou caracterizar o repertório de habilidades sociais de estudantes de Psicologia com base em amostras de 4 localidades: São Paulo (SP), Bahia (BA), Minas Gerais (MG) e Rio de Janeiro (RJ), verificando diferenças entre elas, inclusive em termos da influência do sexo e idade. Quinhentos e sessenta e quatro estudantes responderam 1 inventário de auto-relato IHS-Del-Prette & A. Del Prette, 2001, cujos itens agrupavam-se em 5 fatores: F1) enfrentamento e auto-afirmação; F2) expressão de afeto positivo; F3) conversação e desenvoltura social; F4) auto-exposição a desconhecidos e situações novas; e F5) autocontrole da agressividade. Com base no escore geral (EG) e escores fatoriais (F1, F2, Fe, F4 e F5), foram efetuadas análises comparativas por localidade e, em cada uma delas, por sexo e idade (ANOVA seguida de teste t ou Scheffé). Os resultados indicaram que: a) os estudantes de Psicologia apresentaram escores mais altos que os da amostra normativa no EG, F1, F3 e F4 e inferiores no F2 e F5, mas as diferenças de sexo seguiram os padrões normativos; b) houve influência da localidade, sexo e idade sobre os escores, com interação local-sexo e local-idade; c) as amostra de MG, BA, RJ e SP apresentaram perfil semelhante para F3 e F4, mas RJ apresentou escores mais altos no F1, MG e SP no F2 e F5; d) houve mais diferenças de gênero na BA e menos no RJ; e) as diferenças de idade ocorreram no F4 (favoráveis aos mais novos para SP) e no F5 (favoráveis aos mais velhos para BA e RJ). Discute-se as diferenças e semelhanças encontradas, levantando-se hipóteses e questões para pesquisa adicionais. Palavras-chave: Habilidades sociais; cultura; estudantes de Psicologia; escalas de avaliação.

Interspinous spacers are a minimally invasive surgical alternative for patients with lumbar spinal stenosis (LSS) unresponsive to conservative care. The purpose of this prospective, multicenter, randomized, controlled trial was to compare 2-year clinical outcomes in patients with moderate LSS treated with the Superion® (Experimental) or the X-Stop®, a FDA-approved interspinous spacer (Control). A total of 250 patients with moderate LSS unresponsive to conservative care were randomly allocated to treatment with the Experimental (n = 123) or Control (n = 127) interspinous spacer and followed through 2 years post-treatment. Complication data were available for all patients and patient-reported outcomes were available for 192 patients (101 Experimental, 91 Control) at 2 years. Zurich Claudication Questionnaire (ZCQ) Symptom Severity and Physical Function scores improved 34% to 36% in both groups through 2 years (all p < 0.001). Patient Satisfaction scores at 2 years were 1.8 ± 0.9 with Experimental and 1.6 ± 0.8 with Control. Axial pain decreased from 59 ± 26 mm at baseline to 21 ± 26 mm at 2 years with Experimental and from 55 ± 26 mm to 21 ± 25 mm with Control (both p < 0.001). Extremity pain decreased from 67 ± 24 mm to 14 ± 22 mm at 2 years with Experimental and from 63 ± 24 mm to 18 ± 23 mm with Control (both p < 0.001). Back function assessed with the Oswestry Disability Index similarly improved with Experimental (37 ± 12% to 18 ± 16%) and Control (39 ± 12% to 20 ± 16%) (both p < 0.001). Freedom from reoperation at the index level was 84% for Experimental and 83% for Control (log-rank: p = 0.38) at 2 years. Both interspinous spacers effectively alleviated pain and improved back function to a similar degree through 2 years in patients with moderate LSS who were unresponsive to conservative care.

IMPORTANCE Optimizing radiation therapy techniques for localized prostate cancer can affect patient outcomes. Dose escalation improves biochemical control, but no prior trials were powered to detect overall survival (OS) differences. OBJECTIVE To determine whether radiation dose escalation to 79.2 Gy compared with 70.2 Gy would improve OS and other outcomes in prostate cancer.

A secondary lumbar surgery at a previously surgically treated level is believed to result in minimal clinical improvement. The clinical results of the CHARITE Investigational Device Exemption (IDE) study were analyzed to assess the effect of previous surgery on clinical outcomes following either total disc replacement with the CHARITE device or anterior lumbar interbody fusion with a BAK cage and iliac crest autograft. Patients with prior microdiscectomy, laminectomy, or minimal medial facetectomy were not excluded from enrollment in the CHARITE IDE study. Thus, the following 3 groups were analyzed: all patients treated with the CHARITE Artificial Disc, whether randomized or nonrandomized; only patients treated with CHARITE devices randomized against patients with BAK devices; and control patients with BAK devices. Each group was further subdivided based on the patients' medical history, whether they had undergone prior surgery (prior surgery group) or had not (no prior surgery group). For all groups, baseline demographics were collected and compared for any potential recruitment bias. Postoperative improvements based on Oswestry Disability Index (ODI), visual analog scale (VAS), and patient satisfaction scores were further collected and statistically analyzed. For all 3 groups, there were no statistical differences in clinical improvement from 3 months to 2 years postoperatively as measured using ODI and VAS scores between the subgroups (those who had prior surgery and those who did not). Patients indicated for 1-level lumbar arthroplasty with previous lumbar decompressive surgery can be expected to have similar clinical outcomes to patients undergoing arthroplasty without prior lumbar decompressive surgery. Similarly, candidates for anterior lumbar fusion with prior decompressive surgery may experience similar benefits from the surgical procedure as those without.

A prospective, randomized, multicenter, Food and Drug Administration regulated Investigational Device Exemption (IDE) clinical trial. To discern whether there is a correlation between surgical volume and clinical outcomes, as well as the complication rate and perioperative data points, for lumbar total disc replacement. To examine the early experience for lumbar total disc replacement as part of an IDE study. To our knowledge, an analysis of the effect of surgical volume has not been performed for any spine surgical procedure. Prior reports of the early experience with lumbar total disc replacement consist of retrospective reviews with nonspecific indications. An analysis was performed of the Food and Drug Administration IDE Study of the Charité Artificial Disc (DePuy Spine, Inc., Raynham, MA). Patients enrolled in the control group were omitted from the analysis. Up to 5 nonrandomized cases (representing the early experience) were performed at each site before beginning the randomized arm of the study. There were 3 comparisons performed: nonrandomized cases (71) versus randomized cases (205); randomized cases performed by high-enrolling surgeons versus low-enrolling surgeons; and randomized cases at high-volume institutions versus low-volume institutions. The high-enrolling groups had a significantly lower mean hospital stay and operating time compared to the low-enrolling groups (P < 0.05). High-enrolling surgeons and institutions showed significantly shorter operating times, length of hospital stay, and complication rates. High-enrolling surgeons had significantly fewer device failures and cases of neurologic deterioration. Mean operating time and hospital stay were significantly lower in the randomized group (P < 0.05) compared to the nonrandomized group. Blood loss and approach-related complications were similar between the 2 groups. Device failure requiring removal was 4.2% in the nonrandomized group and 1.5% in the randomized group. Surgeons and institutions with a high volume of lumbar total disc replacement cases have a reduction in key perioperative and postoperative parameters that provide a clinical and/or economic benefit. Surgeons may expect longer hospital stays, higher blood loss, and a higher rate of certain complications in their early experience with total disc replacement procedures, but there was no effect on clinical outcomes.

Spinal cord injury remains with limited natural recovery and only a few general ineffective treatment options. Recent publications have reported enhanced neurologic recovery with the use of methylprednisolone and GM-1 ganglioside. The results of the Maryland GM-1 Ganglioside Study reported a significant drug effect with respect to the fraction of patients that had a change of two or more Frankel grades from entrance into the study to 1-year follow-up. This study formed the basis for the currently ongoing larger placebo-controlled multicentered study using Sygen GM-1 following acute spinal cord injury. This study has entered 797 patients and is expected to present results in early 1998.

The aim of this multicenter study was to assess the treatment quality of the β-thalassemia patients and their survival. The study includes 167 β-thalassemia cases from hospitals in Sofia, Varna, Plovdiv and Stara Zagora. Patients' medical records from hospitals pointed above were used as a source of information as well as expert assessment of the team led this treatment. Appropriate methods of statistical analyses were applied and especially survival analysis. The haemotransfusion therapy among most of the cases studied was received regularly but receiving substitutive and chelation therapy were insufficient. Survival rate among studied cases was 34.5 years and there was a direct relation with the shown expert assessment. The level of medical services had been not optimal yet. The weaknesses especialy from subjective nature were considered as a main reason for the presented situation with substitutive and chelation therapy. The study results were compared with such from similar studies led by distinguished research workers world-wide. The need to initiate the National Program for improvement of treatment and prevention of the β-thalassemia in Bulgaria was obvious.