76 results on '"Brand, Ronald"'
Search Results
2. Percutaneous laser disc decompression versus conventional microdiscectomy for patients with sciatica: Two-year results of a randomised controlled trial.
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Brouwer, Patrick A., Brand, Ronald, van den Akker-van Marle, M. Elske, Jacobs, Wilco C. H., Schenk, Barry, van den Berg-Huijsmans, Annette A., Koes, Bart W., Arts, Mark A., van Buchem, M. A., and Peul, Wilco C.
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SKIN absorption , *SCIATICA , *SCIATIC nerve diseases , *MEDICAL care , *SICK people , *MEDICAL records - Abstract
Background Percutaneous laser disc decompression is a minimally invasive treatment, for lumbar disc herniation and might serve as an alternative to surgical management of sciatica. In a randomised trial with two-year follow-up we assessed the clinical effectiveness of percutaneous laser disc decompression compared to conventional surgery. Materials and methods This multicentre randomised prospective trial with a non-inferiority design, was carried out according to an intent-to-treat protocol with full institutional review board approval. One hundred and fifteen eligible surgical candidates, with sciatica from a disc herniation smaller than one-third of the spinal canal, were randomly allocated to percutaneous laser disc decompression (n = 55) or conventional surgery (n = 57). The main outcome measures for this trial were the Roland-Morris Disability Questionnaire for sciatica, visual analogue scores for back and leg pain and the patient's report of perceived recovery. Results The primary outcome measures showed no significant difference or clinically relevant difference between the two groups at two-year follow-up. The re-operation rate was 21% in the surgery group, which is relatively high, and with an even higher 52% in the percutaneous laser disc decompression group. Conclusion At two-year follow-up, a strategy of percutaneous laser disc decompression, followed by surgery if needed, resulted in non-inferior outcomes compared to a strategy of microdiscectomy. Although the rate of reoperation in the percutaneous laser disc decompression group was higher than expected, surgery could be avoided in 48% of those patients that were originally candidates for surgery. Percutaneous laser disc decompression, as a non-surgical method, could have a place in the treatment arsenal of sciatica caused by contained herniated discs. [ABSTRACT FROM AUTHOR]
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- 2017
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3. THE 2005 HAGUE CHOICE OF COURT CONVENTION IN THE UNITED STATES.
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Brand, Ronald A.
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CONFLICT of laws , *RATIFICATION of treaties , *FEDERAL common law , *FOREIGN judgments - Abstract
The 2005 Hague Convention on Choice of Court Agreements was the result of more than a decade of negotiations at the Hague Conference on Private International Law. While the negotiations began with the goal of a more comprehensive convention, regulating both jurisdiction in the court of origin and recognition of the resulting judgment, the result is an important instrument. It provides the opportunity for predictability when a choice of court agreement is included in an international commercial contract, and places that choice on a more even plane with an arbitration agreement under the New York Convention. By giving effect in all Contracting States to both the choice of court agreement and the resulting judgment, the Hague Convention makes the choice between arbitration and litigation more evenly balanced for purposes of choosing a forum for dispute resolution in international commercial contracts. [ABSTRACT FROM AUTHOR]
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- 2016
4. Percutaneous laser disc decompression versus conventional microdiscectomy in sciatica: a randomized controlled trial.
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Brouwer, Patrick A., Brand, Ronald, van den Akker-van Marle, M. Elske, Jacobs, Wilco C.H., Schenk, Barry, van den Berg-Huijsmans, Annette A., Koes, Bart W., van Buchem, M.A., Arts, Mark P., and Peul, Wilco C.
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SURGICAL decompression , *DISCECTOMY , *SCIATICA treatment , *INTERVERTEBRAL disk hernias , *RANDOMIZED controlled trials , *HEALTH outcome assessment , *THERAPEUTICS - Abstract
Background context Percutaneous laser disc decompression (PLDD) is a minimally invasive treatment for lumbar disc herniation, with Food and Drug Administration approval since 1991. However, no randomized trial comparing PLDD to conventional treatment has been performed. Purpose In this trial, we assessed the effectiveness of a strategy of PLDD as compared with conventional surgery. Study design/Setting This randomized prospective trial with a noninferiority design was carried out in two academic and six teaching hospitals in the Netherlands according to an intent-to-treat protocol with full institutional review board approval. Patient sample One hundred fifteen eligible surgical candidates, with sciatica from a disc herniation smaller than one-third of the spinal canal, were included. Outcome measures The main outcome measures for this trial were the Roland-Morris Disability Questionnaire for sciatica, visual analog scores for back and leg pain, and the patient's report of perceived recovery. Methods Patients were randomly allocated to PLDD (n=57) or conventional surgery (n=58). Blinding was impossible because of the nature of the interventions. This study was funded by the Healthcare Insurance Board of the Netherlands. Results The primary outcome, Roland-Morris Disability Questionnaire, showed noninferiority of PLDD at 8 (−0.1; [95% confidence interval (CI), −2.3 to 2.1]) and 52 weeks (−1.1; 95% CI, −3.4 to 1.1) compared with conventional surgery. There was, however, a higher speed of recovery in favor of conventional surgery (hazard ratio, 0.64 [95% CI, 0.42–0.97]). The number of reoperations was significantly less in the conventional surgery group (38% vs. 16%). Overall, a strategy of PLDD, with delayed surgery if needed, resulted in noninferior outcomes at 1 year. Conclusions At 1 year, a strategy of PLDD, followed by surgery if needed, resulted in noninferior outcomes compared with surgery. [ABSTRACT FROM AUTHOR]
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- 2015
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5. Donor Cytomegalovirus Status Influences the Outcome of Allogeneic Stem Cell Transplant: A Study by the European Group for Blood and Marrow Transplantation.
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Ljungman, Per, Brand, Ronald, Hoek, Jennifer, de la Camara, Rafael, Cordonnier, Catherine, Einsele, Hermann, Styczynski, Jan, Ward, Katherine N., and Cesaro, Simone
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CYTOMEGALOVIRUS diseases , *HOMOGRAFTS , *STEM cell transplantation , *BONE marrow transplantation , *HEMATOPOIETIC stem cells - Abstract
The use of a cytomegalovirus (CMV)–seropositive unrelated hematopoietic stem cell transplant (HSCT) donor for a CMV-seronegative patient results in reduced overall survival. The use of a CMV-seronegative unrelated HSCT donor for a seropositive patient results in reduced overall survival after myeloablative conditioning.Background. The use of a cytomegalovirus (CMV)–seronegative donor for a CMV-seronegative allogeneic hematopoietic stem cell transplant (HSCT) recipient is generally accepted. However, the importance of donor serostatus in CMV-seropositive patients is controversial.Methods. A total of 49 542 HSCT patients, 29 349 seropositive and 20 193 seronegative, were identified from the European Group for Blood and Marrow Transplantation database. Cox multivariate models were fitted to estimate the effect of donor CMV serological status on outcome.Results. Seronegative patients receiving seropositive unrelated-donor grafts had decreased overall survival (hazard ratio [HR], 1.13; 95% confidence interval [CI], 1.06–1.21; P < .0001) compared with seronegative donors, whereas no difference was seen in patients receiving HLA-matched sibling grafts. Seropositive patients receiving grafts from seropositive unrelated donors had improved overall survival (HR, 0.92; 95% CI, .86–.98; P < .01) compared with seronegative donors, if they had received myeloablative conditioning. This effect was absent when they received reduced-intensity conditioning. No effect was seen in patients grafted from HLA-identical sibling donors. The same association was found if the study was limited to patients receiving transplants from the year 2000 onward.Conclusions. We confirm the negative impact on overall survival if a CMV-seropositive unrelated donor is selected for a CMV-seronegative patient. For a CMV-seropositive patient, our data support selecting a CMV-seropositive donor if the patient receives a myeloablative conditioning regimen. [ABSTRACT FROM PUBLISHER]
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- 2014
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6. Randomized, multicenter trial to assess the efficacy, safety and tolerability of a single dose of a novel AMPA receptor antagonist BGG492 for the treatment of acute migraine attacks.
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Gomez-Mancilla, Baltazar, Brand, Ronald, Jürgens, Tim P, Göbel, Harmut, Sommer, Claudia, Straube, Andreas, Evers, Stefan, Sommer, Martin, Campos, Victor, Kalkman, Hans O, Hariry, Sam, Pezous, Nicole, Johns, Donald, and Diener, Hans-Christoph
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CLINICAL drug trials , *EXCITATORY amino acid antagonists , *HEADACHE treatment , *MIGRAINE , *SUMATRIPTAN , *NEUROLOGY - Abstract
The article presents a study which evaluates the safety, efficacy and tolerability of a single dose of a novel amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) receptor antagonist BGG492 for the treatment of acute migraine attacks. A comparison on the effectiveness between BGG492 and sumatriptan is provided. The study concluded that BGG492 was comparable to sumatriptan based on the pain-free responses of the participants.
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- 2014
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7. Does minimally invasive lumbar disc surgery result in less muscle injury than conventional surgery? A randomized controlled trial.
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Arts, Mark, Brand, Ronald, Kallen, Bas, Lycklama à Nijeholt, Geert, and Peul, Wilco
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HERNIA treatment , *LUMBAR vertebrae surgery , *MUSCLE injuries , *RANDOMIZED controlled trials , *SCIATICA , *CREATINE kinase , *MAGNETIC resonance imaging - Abstract
The concept of minimally invasive lumbar disc surgery comprises reduced muscle injury. The aim of this study was to evaluate creatine phosphokinase (CPK) in serum and the cross-sectional area (CSA) of the multifidus muscle on magnetic resonance imaging as indicators of muscle injury. We present the results of a double-blind randomized trial on patients with lumbar disc herniation, in which tubular discectomy and conventional microdiscectomy were compared. In 216 patients, CPK was measured before surgery and at day 1 after surgery. In 140 patients, the CSA of the multifidus muscle was measured at the affected disc level before surgery and at 1 year after surgery. The ratios (i.e. post surgery/pre surgery) of CPK and CSA were used as outcome measures. The multifidus atrophy was classified into three grades ranging from 0 (normal) to 3 (severe atrophy), and the difference between post and pre surgery was used as an outcome. Patients' low-back pain scores on the visual analogue scale (VAS) were documented before surgery and at various moments during follow-up. Tubular discectomy compared with conventional microdiscectomy resulted in a nonsignificant difference in CPK ratio, although the CSA ratio was significantly lower in tubular discectomy. At 1 year, there was no difference in atrophy grade between both groups nor in the percentage of patients showing an increased atrophy grade (14% tubular vs. 18% conventional). The postoperative low-back pain scores on the VAS improved in both groups, although the 1-year between-group mean difference of improvement was 3.5 mm (95% CI; 1.4-5.7 mm) in favour of conventional microdiscectomy. In conclusion, tubular discectomy compared with conventional microdiscectomy did not result in reduced muscle injury. Postoperative evaluation of CPK and the multifidus muscle showed similar results in both groups, although patients who underwent tubular discectomy reported more low-back pain during the first year after surgery. [ABSTRACT FROM AUTHOR]
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- 2011
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8. The NEtherlands Cervical Kinematics (NECK) Trial. Cost-effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in the treatment of cervical disc herniation; a double-blind randomised multicenter study.
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Arts, Mark P., Brand, Ronald, van den Akker, Elske, Koes, Bart W., and Peul, Wilco C.
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KINEMATICS , *DISCECTOMY , *PLASTIC surgery , *MENTAL depression - Abstract
Background: Patients with cervical radicular syndrome due to disc herniation refractory to conservative treatment are offered surgical treatment. Anterior cervical discectomy is the standard procedure, often in combination with interbody fusion. Accelerated adjacent disc degeneration is a known entity on the long term. Recently, cervical disc prostheses are developed to maintain motion and possibly reduce the incidence of adjacent disc degeneration. A comparative cost-effectiveness study focused on adjacent segment degeneration and functional outcome has not been performed yet. We present the design of the NECK trial, a randomised study on cost-effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in patients with cervical disc herniation. Methods/Design: Patients (age 18-65 years) presenting with radicular signs due to single level cervical disc herniation lasting more than 8 weeks are included. Patients will be randomised into 3 groups: anterior discectomy only, anterior discectomy with interbody fusion, and anterior discectomy with disc prosthesis. The primary outcome measure is symptomatic adjacent disc degeneration at 2 and 5 years after surgery. Other outcome parameters will be the Neck Disability Index, perceived recovery, arm and neck pain, complications, re-operations, quality of life, job satisfaction, anxiety and depression assessment, medical consumption, absenteeism, and costs. The study is a randomised prospective multicenter trial, in which 3 surgical techniques are compared in a parallel group design. Patients and research nurses will be kept blinded of the allocated treatment for 2 years. The follow-up period is 5 years. Discussion: Currently, anterior cervical discectomy with fusion is the golden standard in the surgical treatment of cervical disc herniation. Whether additional interbody fusion or disc prothesis is necessary and cost-effective will be determined by this trial. Trial Registration: Netherlands Trial Register NTR1289 [ABSTRACT FROM AUTHOR]
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- 2010
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9. Allogeneic stem cell transplantation for patients with refractory anaemia with matched related and unrelated donors: delay of the transplant is associated with inferior survival.
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de Witte, Theo, Brand, Ronald, van Biezen, Anja, Mufti, Ghulam, Ruutu, Tapani, Finke, Jürgen, von dem Borne, Peter, Vitek, Antonin, Delforge, Michel, Alessandrino, Paolo, Harlahakis, Nicolas, Russell, Nigel, Martino, Roberto, Verdonck, Leo, Kröger, Nicholas, and Niederwieser, Dietger
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STEM cell transplantation , *HLA histocompatibility antigens , *APLASTIC anemia , *ANEMIA diagnosis , *CELLULAR therapy - Abstract
Allogeneic stem cell transplantation (alloSCT) for patients with refractory anaemia may result in a 50% event-free survival, but the high non-relapse mortality (NRM) precludes a general application of this therapeutic modality. This study evaluated the impact of various pre-transplant variables, including disease duration, intensity of the conditioning regimen, type of donor and year of transplantation on outcome. The study population consisted of 374 patients; 244 were transplanted from human leucocyte antigen (HLA)-identical siblings and 130 patients from matched unrelated donors. The median age was 39 years. One hundred and two patients were transplanted after reduced intensity conditioning (RIC). The overall 4-year survival was 52%. The 4-year survival of patients transplanted with HLA-identical sibling donors and matched unrelated donors was 52% and 50%, respectively. Multivariate analysis showed an improved survival ( P = 0·05) and a lower NRM ( P = 0·02) when the transplantation was performed in recent years. Increasing age, and disease duration of >12 months were associated with inferior survival. RIC resulted in a similar survival despite an increased relapse risk ( P = 0·02). This improved outcome permits alloSCT in patients older than 50 years of age, even with the use of matched unrelated donors. AlloSCT should be preferentially performed early after diagnosis after careful analysis of prognostic variables. [ABSTRACT FROM AUTHOR]
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- 2009
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10. Lower limb deformity due to failed trauma treatment corrected with the llizarov technique.
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Oostenbroek, Hubert J, Brand, Ronald, and van Roermund, Peter M
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BONE fractures , *LEG , *FEMUR , *TIBIA , *ORTHOPEDICS , *PATIENTS - Abstract
Background and purpose Failed treatment of fractures may be corrected by the Ilizarov technique but complications are common. In 52 patients with compromised healing of femoral and tibial fractures, the results of secondary reconstruction with Ilizarov treatment were investigated retrospectively in order to identify the factors that contribute to the risk of complications. Methods 52 consecutive patients was analyzed. The median interval between injury and secondary reconstruction was 3 (0.1-27) years. The patients had failed fracture treatment resulting in bone defects, pseudarthrosis, infection, limb length discrepancy (LLD) caused by bone consolidation after bone loss, malunion, soft-tissue loss, and stiff joints. Most patients had a combination of these deformities. The results were analyzed by using logistic regression in a polytomous universal mode (PLUM) logistic regression model. Results The median treatment time was 9 (4-30) months, and the obstacle and complication rate was 105% per corrected bone segment. In 2 patients treatment failed, which resulted in amputation. In all other patients healing of nonunion could be established, malunion could be corrected, and infections were successfully treated. The statistical analysis revealed that relative bone loss of the affected bone was the only predictor for occurrence of complications. From these data, we constructed a simple graph that shows the relationship between relative bone loss of the affected bone and risk of complications. Interpretation Relative bone loss of the affected bone segment is the main predictor of complications after Ilizarov treatment of previously failed fracture treatment. The visualization of the analysis in a simple graph may assist comparison of the complication rates in the literature. [ABSTRACT FROM AUTHOR]
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- 2009
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11. Tubular Diskectomy vs Conventional Microdiskectomy for Sciatica.
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Arts, Mark P., Brand, Ronald, van den Akker, M. Elske, Koes, Bart W., Bartels, Ronald H. M. A., and Peul, Wilco C.
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SCIATICA , *HEALTH outcome assessment , *DISCECTOMY , *SURGERY , *QUESTIONNAIRES , *SCIATIC nerve diseases - Abstract
The article discusses a study which examined outcomes and time to recovery in patients treated with tubular diskectomy compared with conventional microdiskectomy. Functional assessment on the Roland-Morris Disability Questionnaire (RDQ) for sciatica was the primary outcome of the study. Results showed that the mean RDQ score during the first year after surgery was 6.2 for tubular diskectomy and 5.4 for conventional microdiskectomy. At one year, 69% of the patients assigned to tubular diskectomy reported a good recovery. It was concluded that use of tubular diskectomy did not result in a significant improvement in the RDQ score.
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- 2009
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12. Growth rate after limb deformity correction by the Ilizarov method with or without knee joint distraction.
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Oostenbroek, Hubert J, Brand, Ronald, and van Roermund, Peter M
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ABNORMALITIES in the anatomical extremities , *EXTREMITIES (Anatomy) -- Surgery , *KNEE , *JOINT surgery , *CHILDREN'S health - Abstract
Background and purpose Growth inhibition and stimulation have both been reported after juvenile limb lengthening. Distraction of a joint usually suspends and unloads the growth plate and may stimulate growth. We investigated the influence of knee joint distraction on the speed of growth after limb lengthening. Methods In a retrospective study, growth patterns were analyzed in 30 children mean 61 (24-109) months after limb lengthening with the Ilizarov method, each child having more than 2 years of remaining growth. In 14 patients with knee joint instability, the knee was bridged over during lengthening for joint stabilization. Whether or not joint bridging and distraction would affect patterns of growth of the lengthened limb by unloading the growth plate was evaluated with a repeated measurements analysis of variance. Results After lengthening procedures, the proportionate leg-length discrepancy was found to decrease in 16 children, suggesting increased growth rate in the lengthened limbs. A statistically significantly faster growth rate was seen in 8 of 14 patients with knee distraction as compared to patients with single bone frame configurations. Interpretation Further research is required to investigate whether growth stimulation is due to the surgical technique and whether joint distraction should be recommended during limb lengthening in growing children. [ABSTRACT FROM AUTHOR]
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- 2009
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13. THE EUROPEAN MAGNET AND THE U.S. CENTRIFUGE: TEN SELECTED PRIVATE INTERNATIONAL LAW DEVELOPMENTS OF 2008.
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Brand, Ronald A.
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CONFLICT of laws , *LEGISLATION , *ADMINISTRATIVE procedure - Abstract
The article discusses the developments in private international law in 2008 which, in the author's view, reflect the influence of European Community legislation and adjudication. It mentions the role of the states of the U.S. in the development of external private international law rules for the country. Also cited is that the clear migration of competence for private international law in the European Union (EU) from Member State governments to the institutions of the European Community has been shown by the Rome I and II Regulations.
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- 2009
14. Improving prediction of "inevitable" surgery during non-surgical treatment of sciatica.
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Peul, Wilco C, Brand, Ronald, Thomeer, Ralph T W M, and Koes, Bart W
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A randomized trial showed that surgery speeds up recovery of patients suffering sciatica for 6 weeks but prolonged conservative care yields similar results at one year. However 39% of this conservative care group ultimately underwent surgery after a mean period of 18.7 weeks. We evaluated variables to improve prediction of surgery in the conservatively treated cohort. Baseline data on 142 patients enroled in the conservative treatment arm of a randomized trial were analyzed to select those that could contribute to the prediction of surgery. The actual occurrence of surgery was used as dependent outcome of interest. Variables measured at baseline included neurological examination results, the visual analogue scale for pain (VAS) and the Roland disability questionnaire (RDQ). Higher pain intensity and functional limitations at baseline were associated with an increased likelihood of surgery during follow-up. Mutually adjusted Odds Ratios of 1.7 (95% CI; 1.1-2.7) per 20mm incremental intensification of pain on the VAS score and 1.8 (95% CI; 1.2-2.9) per 3 points of deterioration of the RDQ score quantify the increasing chance of undergoing delayed surgery. Despite maximal efforts to the contrary, surgery could not be prevented for a considerable proportion of patients in a conservatively treated cohort. Compared to those with lower scores initially, patients with more intense leg pain or higher disability scores were at higher risk to undergo delayed surgery. The individual surgical decision process is facilitated by the use of pain and disability scales complemented by patient preferences. [ABSTRACT FROM AUTHOR]
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- 2008
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15. Improving prediction of “inevitable” surgery during non-surgical treatment of sciatica
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Peul, Wilco C., Brand, Ronald, Thomeer, Ralph T.W.M., and Koes, Bart W.
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SCIATICA , *MEDICAL care , *COHORT analysis , *VISUAL analytics - Abstract
Abstract: A randomized trial showed that surgery speeds up recovery of patients suffering sciatica for 6 weeks but prolonged conservative care yields similar results at one year. However 39% of this conservative care group ultimately underwent surgery after a mean period of 18.7 weeks. We evaluated variables to improve prediction of surgery in the conservatively treated cohort. Baseline data on 142 patients enroled in the conservative treatment arm of a randomized trial were analyzed to select those that could contribute to the prediction of surgery. The actual occurrence of surgery was used as dependent outcome of interest. Variables measured at baseline included neurological examination results, the visual analogue scale for pain (VAS) and the Roland disability questionnaire (RDQ). Higher pain intensity and functional limitations at baseline were associated with an increased likelihood of surgery during follow-up. Mutually adjusted Odds Ratios of 1.7 (95% CI; 1.1–2.7) per 20mm incremental intensification of pain on the VAS score and 1.8 (95% CI; 1.2–2.9) per 3 points of deterioration of the RDQ score quantify the increasing chance of undergoing delayed surgery. Despite maximal efforts to the contrary, surgery could not be prevented for a considerable proportion of patients in a conservatively treated cohort. Compared to those with lower scores initially, patients with more intense leg pain or higher disability scores were at higher risk to undergo delayed surgery. The individual surgical decision process is facilitated by the use of pain and disability scales complemented by patient preferences. [Copyright &y& Elsevier]
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- 2008
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16. Influence of gender and other prognostic factors on outcome of sciatica.
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Peul, Wilco C, Brand, Ronald, Thomeer, Ralph T W M, and Koes, Bart W
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Sciatica caused by a lumbar disk herniation is a frequently diagnosed disorder with a favorable natural course. While most prognostic studies focus on good outcome, patients might experience unsatisfactory results. Female gender has been found to be associated with chronic pain in other musculoskeletal disorders. Our aim is to quantify the relationship between gender and (1) rate of recovery and (2) outcome at one year. Recovery was registered on a 7-point Likert scale for 283 patients with 6-12 weeks of persistent sciatica who participated in a randomized trial to investigate timing of surgery. Complete and near complete recovery were considered good outcomes. Function and pain were registered by the Roland Disability Questionnaire (RDQ) and a visual analogue scale (VAS). A univariate Cox model was used to study the influence of variables on rate of recovery while a univariate and multivariate logistic regression analysis evaluated variables predicting unsatisfactory outcome at 12 months. At one year unsatisfactory outcome was registered for 17% of patients, 11% of all males and 28% of all females (p<0.001). Patients with an unsatisfactory outcome had worse RDQ and VAS scores compared to those who recovered satisfactorily (p<0.001). Women had a slower rate of recovery: HR 0.76 (95% CI 0.59-0.99) and xbfnkbsdkvbated with an unsatisfactory outcome represented by an unadjusted odds ratio of 3.3 (95% CI 1.7-6.3) compared to males. Besides a slower recovery rate, female gender was a strong predictor of unsatisfactory outcome at one year for patients with sciatica. [ABSTRACT FROM AUTHOR]
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- 2008
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17. Influence of gender and other prognostic factors on outcome of sciatica
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Peul, Wilco C., Brand, Ronald, Thomeer, Ralph T.W.M., and Koes, Bart W.
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HERNIA , *SCIATICA , *ETIOLOGY of diseases , *CHRONIC pain - Abstract
Abstract: Sciatica caused by a lumbar disk herniation is a frequently diagnosed disorder with a favorable natural course. While most prognostic studies focus on good outcome, patients might experience unsatisfactory results. Female gender has been found to be associated with chronic pain in other musculoskeletal disorders. Our aim is to quantify the relationship between gender and (1) rate of recovery and (2) outcome at one year. Recovery was registered on a 7-point Likert scale for 283 patients with 6–12 weeks of persistent sciatica who participated in a randomized trial to investigate timing of surgery. Complete and near complete recovery were considered good outcomes. Function and pain were registered by the Roland Disability Questionnaire (RDQ) and a visual analogue scale (VAS). A univariate Cox model was used to study the influence of variables on rate of recovery while a univariate and multivariate logistic regression analysis evaluated variables predicting unsatisfactory outcome at 12 months. At one year unsatisfactory outcome was registered for 17% of patients, 11% of all males and 28% of all females (p <0.001). Patients with an unsatisfactory outcome had worse RDQ and VAS scores compared to those who recovered satisfactorily (p <0.001). Women had a slower rate of recovery: HR 0.76 (95% CI 0.59–0.99) and xbfnkbsdkvbated with an unsatisfactory outcome represented by an unadjusted odds ratio of 3.3 (95% CI 1.7–6.3) compared to males. Besides a slower recovery rate, female gender was a strong predictor of unsatisfactory outcome at one year for patients with sciatica. [Copyright &y& Elsevier]
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- 2008
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18. Results of Hematopoietic Stem Cell Transplantation After Treatment With Different High-Dose Total-Body Irradiation Regimens in Five Dutch Centers
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van Kempen-Harteveld, M. Loes, Brand, Ronald, Kal, Henk B., Verdonck, Leo F., Hofman, Pieter, Schattenberg, Anton V., van der Maazen, Richard W., Cornelissen, Jan J., Eijkenboom, Wil M.H., van der Lelie, Johannes P., Oldenburger, Foppe, Barge, Renée M., van Biezen, Anja, Vossen, Jaak M.J.J., Noordijk, Evert M., and Struikmans, Henk
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HEMATOPOIETIC stem cells , *STEM cell transplantation , *ACUTE leukemia , *RADIOTHERAPY - Abstract
Purpose: To evaluate results of high-dose total-body irradiation (TBI) regimens for hematopoietic stem cell transplantation. Methods and Materials: A total of 1,032 patients underwent TBI in one or two fractions before autologous or allogeneic hematologic stem cell transplantation for acute leukemia and non-Hodgkin''s lymphoma. The TBI regimens were normalized by using the biological effective dose (BED) concept. The BED values were divided into three dose groups. Study end points were relapse incidence (RI), non-relapse mortality (NRM), relapse-free survival (RFS), and overall survival (OS). Multivariate analysis was performed, stratified by disease. Results: In the highest TBI dose group, RI was significantly lower and NRM was higher vs. the lower dose groups. However, a significant influence on RFS and OS was not found. Relapses in the eye region were found only after shielding to very low doses. Age was of significant influence on OS, RFS, and NRM in favor of younger patients. The NRM of patients older than 40 years significantly increased, and OS decreased. There was no influence of age on RI. Men had better OS and RFS and lower NRM. Type of transplantation significantly influenced RI and NRM for patients with acute leukemia and non-Hodgkin''s lymphoma. There was no influence on RFS and OS. Conclusions: Both RI and NRM were significantly influenced by the size of the BED of single-dose or two-fraction TBI regimens; OS and RFS were not. Age was of highly significant influence on NRM, but there was no influence of age on RI. Hyperfractionated TBI with a high BED might be useful, assuming NRM can be reduced. [Copyright &y& Elsevier]
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- 2008
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19. TOTAL ANKLE ARTHROPLASTY IN INFLAMMATORY JOINT DISEASE WITH USE OF TWO MOBILE-BEARING DESIGNS.
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Doets, H. Cornelis, Brand, Ronald, and Nelissen, Rob G. H. H.
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ARTHROPLASTY , *ANKLE , *SURGERY , *RHEUMATOID arthritis , *PROSTHETICS , *JOINT surgery - Abstract
Background: Interest in mobile-bearing total ankle arthroplasty has increased in recent years. However, to our knowledge, no study has focused exclusively on patients with the diagnosis of inflammatory joint disease or has provided a detailed analysis of the risk factors for failure. Methods: A prospective observational study of the results of cementless mobile-bearing total ankle arthroplasty in patients with inflammatory joint disease (mainly rheumatoid arthritis) was conducted at two centers. Ninety-three total ankle arthroplasties were performed. The LCS (low contact stress) prosthesis was used initially, in nineteen ankles, between 1988 and 1992, and a modification of the LCS prosthesis, the Buechel-Pappas design, was used in seventy-four ankles between 1993 and 1999. Clinical and radiographic follow-up was performed at yearly intervals. Three clinical scoring systems were used, and any complication was recorded throughout follow-up. Actuarial survival (with revision as the end point), multivariate analysis, and a competing risk approach were used to describe the longterm outcome. Results: The clinical result at one year after surgery showed a significant improvement in the scores on all three scoring systems (p < 0.05). Ankle dorsiflexion (mean, 7°) also improved significantly (p < 0.05) compared with the preoperative state. The most frequent complication was a malleolar fracture, which occurred in twenty ankles. Only when it occurred in combination with a deformity in the frontal plane did this complication have an adverse effect on the end result. At a mean follow-up of eight years, seventeen patients (twenty-one ankles) had died and fifteen ankles had been revised because of aseptic loosening (six ankles), primary or secondary axial deformity with edge-loading (six ankles), deep infection (two ankles), and a severe wound-healing problem (one ankle), leaving fifty-seven ankles (61%) that were evaluated. The mean overall survival rate at eight years was 84%. An increased failure rate was encountered in ankles with a preoperative deformity in the frontal plane of >10° (p = 0.03) and in ankles in which an undersized tibial component had been implanted (p = 0.02). Conclusions: Mobile-bearing total ankle arthroplasty is a valid treatment option for the rheumatoid ankle if proper indications are used. Aseptic loosening and persistent deformity are the most important modes of failure. Level of Evidence: Therapeutic Level IV. See Instructions to Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]
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- 2006
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20. THE LUGANO CASE IN THE EUROPEAN COURT OF JUSTICE: EVOLVING EUROPEAN UNION COMPETENCE IN PRIVATE INTERNATIONAL LAW.
- Author
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Brand, Ronald A.
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LAW & economic development , *INTERNATIONAL economic relations , *TREATIES , *INTERNATIONAL law , *EUROPEAN integration - Abstract
Considers a European Court of Justice case involving the impact of a request by the Council of the European Union on whether the Community has exclusive or shared competence to conclude the Lugano Convention, a convention dealing with jurisdiction and the enforcement of judgment on civil and commercial matter. Implications of the Lugano case for the development of private international law and private law on a Community level; Comparison between the Treaty of Rome creating the European Economic Community and the U.S. Constitution; Cross-border implications of the Community's judicial cooperation in civil matters; Instances where the question of external competence in the area of judicial cooperation has surfaced.
- Published
- 2005
21. Increased risk of dislocation after primary total hip arthroplasty in inflammatory arthritis.
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Zwartelé, Rob E., Brand, Ronald, and Doets, H. Cornelis
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TOTAL hip replacement , *ARTHRITIS , *ARTHROPLASTY , *OSTEOARTHRITIS , *PROSTHETICS , *JOINT diseases - Abstract
Background It is unclear whether patients with inflammatory arthritis have a higher risk of dislocation after hip replacement. Patients and material We carried out a prospective study assessing the incidence of dislocation within 2 years after surgery for patients diagnosed with inflammatory arthritis (IA) and osteoarthrosis (OA). One single type of prosthesis was implanted using a lateral approach. Both diagnostic groups were compared by univariate analysis with respect to dislocation, sex, age, diagnosis, prior hip surgery, experience of the surgeon and malposition of the acetabular component. In a multivariate logistic regression approach, the difference in dislocation incidence was assessed after adjusting for the effect of the potential confounders given above. Between 1996 and 1999, 410 THA were performed: 70 in IA and 340 in OA. After 2 years no patients were lost to follow-up, but 12 patients had died, and 5 revisions were carried out for reasons other than dislocation. Results The dislocation rate in patients with IA was higher than in patients with OA: 10% (7 hips) in the IA group and 3% (10 hips) in the OA group (p = 0.006). No significant differences were found among the risk factors for dislocation between the two groups. Multivariate logistic regression analysis showed that IA is an independent risk factor for dislocation (odds ratio (OR) 3.7, 95% CI 1.3-11), together with malposition of the cup in more than 55° abduction (OR 7.7, CI 2.3-26) and increased anteversion (OR 7.6, CI 1.4-42.4). Interpretation Our findings clearly suggest that inflammatory arthritis has to be considered as an independent risk factor for dislocation after primary THA. [ABSTRACT FROM AUTHOR]
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- 2004
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22. A GLOBAL CONVENTION ON CHOICE OF COURT AGREEMENTS.
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Brand, Ronald A.
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DIPLOMATIC negotiations in international disputes , *NEGOTIATION , *INTERNATIONAL law , *INTERNATIONAL relations , *COURTS - Abstract
Discusses the global negotiation on the Draft Text on Choice of Court Agreements. Information on the meeting of a Special Commission of the Hague Conference on Private International Law; Purpose of the Draft Text rules; Basic rules created by the Draft Text upon which the operation of the Convention turns; Exceptions to the rule; Changes made in earlier drafts on the issue of validity of a choice of court agreement.
- Published
- 2004
23. Comparative Forum Non Conveniens and the Hague Convention on Jurisdiction and Judgments.
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Brand, Ronald A.
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FORUM non conveniens , *LIS pendens - Abstract
Discusses the applicability of the forum non conveniens doctrine under four law legal systems. Differences on the focus and effect of the doctrine from country to country; Role of the forum non conveniens doctrine on transnational litigation; Difference between forum non conveniens and lis alibi pendens approaches.
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- 2002
24. Uni-State Lawyers and Multinational Practice: Dealing with International, Transnational, and Foreign Law.
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Brand, Ronald A.
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PRACTICE of law , *PROFESSIONAL ethics - Abstract
Examines how a United States lawyer may ethically engage in a transnational practice. Background on the American Bar Association Model Rules of Professional Conduct; Information on tests for determining unauthorized practice of law; Examples illustrating the legal framework for determining a lawyer's unauthorized practice of law; Recommendations for addressing ethical issues concerning the international practice of law.
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- 2001
25. International decisions.
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Brand, Ronald A.
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TRIALS (Law) , *ACTIONS & defenses (Law) - Abstract
Presents the court case `Farrel Corp. versus International Trade Commission (ITC)'. Denial of an effort to compel arbitration; Section 337 of the Tariff Act of 1930 on the violation of intellectual property laws; Dismissal of infringement action on Pomini's marketing of mixing machines; Supreme Court's decision on `Gilmer'.
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- 1993
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26. Exporting Legal Education.
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BRAND, RONALD
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LEGAL education , *LAW schools , *GRADUATES , *PRACTICE of law , *UNITED States education system - Abstract
The author discusses the lessons learned from the efforts of U.S. legal education in bringing change in transition countries. He looks to law schools around the globe, especially in transition countries, for examples of what should be considered before U.S. law schools engage in such change. He highlights the need to evaluate what are being done in U.S. law schools by the impact they have on the rest of the world and by the impact they have on their graduates who will practice law in the U.S. The standards to be achieved should be how far U.S. legal education takes the world.
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- 2010
27. Ototopical drops containing a novel antibacterial synthetic peptide: Safety and efficacy in adults with chronic suppurative otitis media.
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Peek, Nanno F. A. W., Nell, Marja J., Brand, Ronald, Jansen-Werkhoven, Thekla, van Hoogdalem, Ewoud J., Verrijk, Ruud, Vonk, Marcel J., Wafelman, Amon R., Valentijn, A. Rob P. M., Frijns, Johan H. M., Hiemstra, Pieter S., Drijfhout, Jan W., Nibbering, Peter H., and Grote, Jan J.
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OTITIS media , *DRUG resistance in bacteria , *MIDDLE ear , *EAR canal - Abstract
Objective: Chronic suppurative otitis media (CSOM) is a chronic infectious disease with worldwide prevalence that causes hearing loss and decreased quality of life. As current (antibiotic) treatments often unsuccessful and antibiotic resistance is emerging, alternative agents and/or strategies are urgently needed. We considered the synthetic antimicrobial and anti-biofilm peptide P60.4Ac to be an interesting candidate because it also displays anti-inflammatory activities including lipopolysaccharide-neutralizing activity. The aim of the present study was to investigate the safety and efficacy of ototopical drops containing P60.4Ac in adults with CSOM without cholesteatoma. Methods: We conducted a range-finding study in 16 subjects followed by a randomized, double blinded, placebo-controlled, multicentre phase IIa study in 34 subjects. P60.4Ac-containing ototopical drops or placebo drops were applied twice a day for 2 weeks and adverse events (AEs) and medication use were recorded. Laboratory tests, swabs from the middle ear and throat for bacterial cultures, and audiometry were performed at intervals up to 10 weeks after therapy. Response to treatment was assessed by blinded symptom scoring on otoscopy. Results: Application of P60.4Ac-containing ototopical drops (0.25–2.0 mg of peptide/ml) in the ear canal of patients suffering from CSOM was found to be safe and well-tolerated. The optimal dose (0.5 mg of peptide/ml) was selected for the subsequent phase IIa study. Safety evaluation revealed only a few AEs that were unlikely related to study treatment and all, except one, were of mild to moderate intensity. In addition to this excellent safety profile, P60.4Ac ototopical drops resulted in a treatment success in 47% of cases versus 6% in the placebo group. Conclusion: The efficacy/safety balance assessed in the present study provides a compelling justification for continued clinical development of P60.4Ac in therapy-resistant CSOM. [ABSTRACT FROM AUTHOR]
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- 2020
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28. Gender gaps in transplantation.
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Gratwohl, Alois, Snowden, John A., and Brand, Ronald
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GENDER , *HEMATOPOIETIC stem cell transplantation - Abstract
Keywords: gender; gender gap; hematopoietic stem cell transplantation; sex; transplantation EN gender gender gap hematopoietic stem cell transplantation sex transplantation e123 e125 3 07/20/20 20200715 NES 200715 According to a current review, fewer female patients receive a solid organ than males, and women are more likely to be living donors or to become deceased donors. We tested the hypothesis that the proportion of female patients or donors could correlate with the countries' GapIndex in the World Economic Forum (WEF) Gender Gap ranking list.3 I TableGender distribution in 184 368 patients and donors for HSCT in 39 countries and the association with their countries' global index (GapIndex) in the World Economic Forum gender gap ranking list. The proportion of I female donors i varied as widely but was lower than of male donors among HLA-identical sibling donor and other family donor transplants (47% vs 42% respectively), and even lower for unrelated donor transplants (31%; range 0-53%). [Extracted from the article]
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- 2020
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29. Percutaneous laser disc decompression versus microdiscectomy for sciatica: Cost utility analysis alongside a randomized controlled trial.
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den Akker-van Marle, M. Elske van, Brouwer, Patrick A., Brand, Ronald, Koes, Bart, den Hout, Wilbert B. van, van Buchem, Mark A., and Peul, Wilco C.
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- *
HERNIA , *HEALTH surveys , *SCIATICA , *MEDICAL care costs , *HERNIA surgery , *RANDOMIZED controlled trials - Abstract
Background: Percutaneous laser disc decompression (PLDD) for patients with lumbar disc herniation is believed to be cheaper than surgery. However, cost-effectiveness has never been studied. Materials and Methods: A cost utility analysis was performed alongside a randomized controlled trial comparing PLDD and conventional surgery. Patients reported their quality of life using the EuroQol five dimensions questionnaire (EQ-5D), 36-item short form health survey (SF-36 and derived SF-6D) and a visual analogue scale (VAS). Using cost diaries patients reported health care use, non-health care use and hours of absenteeism from work. The 1-year societal costs were compared with 1-year quality adjusted life years (QALYs) based on the United States (US) EQ-5D. Sensitivity analyses were carried out on the use of different utility measures (Netherland (NL) EQ-5D, SF-6D, or VAS) and on the perspective (societal or healthcare). Results: On the US EQ-5D, conventional surgery provided a non-significant gain in QALYs of 0.033 (95% confidence interval (CI) €0.026 to 0.093) in the first year. PLDD resulted in significantly lower healthcare costs (difference E1771, 95% CI E303 to E3238) and non-significantly lower societal costs (difference E2379, 95% CI €E2860 to E7618). For low values of the willingness to pay for a QALY, the probability of being cost-effective is in favor of PLDD. For higher values of the willingness to pay, between E30,000 and E70,000, conventional microdiscectomy becomes favorable. Conclusions: From a healthcare perspective PLDD, followed by surgery when needed, results in significantly lower 1-year costs than conventional surgery. From a societal perspective PLDD appears to be an economically neutral innovation. [ABSTRACT FROM AUTHOR]
- Published
- 2017
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30. Comparison of Allogeneic Stem Cell Transplantation and Non-Transplant Approaches in Elderly Patients with Advanced Myelodysplastic Syndrome: Optimal Statistical Approaches and a Critical Appraisal of Clinical Results Using Non-Randomized Data.
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Brand, Ronald, Putter, Hein, van Biezen, Anja, Niederwieser, Dietger, Martino, Rodrigo, Mufti, Ghulam, Onida, Francesco, Symeonidis, Argiris, Schmid, Christoph, Garderet, Laurent, Robin, Marie, van Gelder, Michel, Finke, Jürgen, Bornhäuser, Martin, Kobbe, Guido, Germing, Ulrich, de Witte, Theo, and Kröger, Nicolaus
- Subjects
- *
HOMOGRAFTS , *STEM cell transplantation , *MYELODYSPLASTIC syndromes , *DISEASES in older people , *CLINICAL trials , *DATA analysis , *COMPARATIVE studies , *PATIENTS - Abstract
Allogeneic stem cell transplantation (ASCT) from related or unrelated donors may cure patients with myelodysplastic syndromes (MDS), a heterogeneous group of clonal stem cell disorders. We analysed 384 elderly patients (55-69 years) with advanced MDS who received either ASCT (n=247) and were reported to The European Group for Blood and Marrow Transplantation (EBMT) or a non –transplant approach (n=137) reported to the Düsseldorf registry. Besides an attempt to answer the question of „comparison“, the purpose of this work is to explain the difficulties in comparing a non-transplant with a transplant cohort, when death before transplant is likely but unknown and the selection of patients for transplant is based on assumptions. It shows which methods are almost always biased and that even the most sophisticated approaches crucially rely on clinical assumptions. Using the most appropriate model for our data, we derive an overall univariate non-significant survival disadvantage for the transplant cohort (HR: 1.29, p = 0.11). We show that such an “average” hazard ratio is however misleading due to non-proportionality of the hazards reflecting early treatment related mortality, the occurring of which is logically correlated with the interval between diagnosis and transplant creating a disproportional drop in the (reconstructed) survival curve of the transplanted patients. Also in multivariate analysis (correcting for age > 60 (HR: 1.4, p = 0.02) and abnormal cytogenetics (HR: 1.46, p = 0.01)), transplantation seems to be worse (HR: 1.39, p = 0.05) but only in the (incorrect but commonly applied) model without time varying covariates. The long term (time depending) hazard ratio is shown to be virtually 1 and overall survival is virtually identical in both groups. Nonetheless no conclusion can be reached from a clinical point of view without assumptions which are by their very nature untestable unless all patients would be followed from diagnosis. [ABSTRACT FROM AUTHOR]
- Published
- 2013
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31. Assessment of Patient-Specific Surgery Effect Based on Weighted Estimation and Propensity Scoring in the Re-Analysis of the Sciatica Trial.
- Author
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Mertens, Bart J. A., Jacobs, Wilco C. H., Brand, Ronald, and Peul, Wilco C.
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SCIATICA , *SURGERY , *RANDOMIZED controlled trials , *SURGICAL complications , *GOVERNMENT policy - Abstract
We consider a re-analysis of the wait-and-see (control) arm of a recent clinical trial on sciatica. While the original randomised trial was designed to evaluate the public policy effect of a conservative wait-and-see approach versus early surgery, we investigate the impact of surgery at the individual patient level in a re-analysis of the wait-and-see group data. Both marginal structural model re-weighted estimates as well as propensity score adjusted analyses are presented. Results indicate that patients with high propensity to receive surgery may have beneficial effects at 2 years from delayed disc surgery. [ABSTRACT FROM AUTHOR]
- Published
- 2014
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32. Design of the Verbiest trial: cost-effectiveness of surgery versus prolonged conservative treatment in patients with lumbar stenosis.
- Author
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Overdevest, Gijsbert M., Luijsterburg, Pim A. J., Brand, Ronald, Koes, Bart W., Bierma-Zeinstra, Sita M. A., Eekhof, Just A. H., Vleggeert-Lankamp, Carmen L. A. M., and Peul, Wilco C.
- Subjects
- *
STENOSIS , *CLINICAL trials , *DISEASE complications , *CLINICAL medicine , *INTERMITTENT claudication - Abstract
Background: Degenerative changes of lumbar spine anatomy resulting in the encroachment of neural structures are often regarded progressive, ultimately necessitating decompressive surgery. However the natural course is not necessarily progressive and the efficacy of a variety of nonsurgical interventions has also been described. At present there is insufficient data to compare surgical and nonsurgical interventions in terms of their relative benefit and safety. Previous attempts failed to provide clear clinical recommendations or to distinguish subgroups that substantially benefit from a certain treatment strategy. We present the design of a randomized controlled trial on (cost-) effectiveness of surgical decompression versus prolonged conservative treatment in patients with neurogenic intermittent claudication caused by lumbar stenosis. Methods/Design: The aim of the Verbiest trial is to evaluate the effectiveness of prolonged conservative treatment compared to decompressive surgery. The study is a multi-center randomized controlled trial with two parallel groups design. Patients (age over 50) presenting to the neurologist or neurosurgeon with at least 3 months complaints of neurogenic intermittent claudication and considering surgical treatment are eligible for inclusion. Participants are randomly allocated to either prolonged conservative treatment, receiving further treatment from their general practitioner and physical therapist, or allocated to surgery and operated within 4 weeks. Primary outcome measure is the functional assessment of the patient as measured by the Zurich Claudication Questionnaire at 24 months of follow-up. Data is analyzed according to the intention to treat principle. Discussion: With a cost-effectiveness analysis the trade off between the costs of prolonged conservative treatment and delayed surgery in a smaller number of patients are compared with the current policy of surgical management. As surgery is expected to be inevitable in certain subgroups of patients, the distinction of and classification by predictive patient characteristics is most relevant to clinical practice. Trial registration: Netherlands Trial Register (NTR): NTR2216 [ABSTRACT FROM AUTHOR]
- Published
- 2011
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33. Postoperative anemia after joint replacement surgery is not related to quality of life during the first two weeks postoperatively.
- Author
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So-Osman, Cynthia, Nelissen, Rob, Brand, Ronald, Brand, Anneke, and Stiggelbout, Anne M.
- Subjects
- *
LEG surgery , *QUALITY of life , *CLINICAL trials , *ANEMIA , *SURGICAL complications , *HEMOGLOBINS , *REGRESSION analysis - Abstract
Lower limb joint replacement surgery provides a considerable improvement in quality of life (QoL), but is associated with peroperative blood loss and with anemia in the direct postoperative period. General acceptance of low transfusion thresholds and shorter postoperative hospital stays will result in patients leaving hospital with low hemoglobin (Hb) levels. To evaluate the role of QoL scores as a possible alternative for Hb values to serve as a further indicator for red blood cell transfusion, we performed a secondary analysis of a previously conducted randomized clinical trial to compare QoL and fatigue scores with simultaneously measured pre- and postoperative Hb levels, in total hip and knee arthroplasty patients. QoL measurement was measured preoperatively and twice up to 14 days postoperatively using the Functional Status Index (FSI), the Visual Analogue Score (VAS)-Fatigue score, and the Functional Assessment of Cancer Therapy Anemia (FACT-Anemia) subscale. Pearson correlation coefficients between (change in) FSI, VAS-Fatigue, and FACT-Anemia subscale scores and (change in) Hb levels were calculated. Additionally, partial correlations were calculated and linear regression analysis was performed, correcting for possible confounding variables. A total of 603 patients were evaluated. All patients scored worse postoperatively, but none of the scores correlated with Hb values, neither after correcting for confounding factors. Even more, the changes between preoperative and postoperative Hb levels were not correlated with changes in fatigue scores. In hip and knee prosthesis surgery no correlation existed between postoperative Hb levels or acute postoperative decline in Hb values and QoL scores (FSI, VAS-Fatigue, or FACT-Anemia). [ABSTRACT FROM AUTHOR]
- Published
- 2011
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34. The Felix-trial. Double-blind randomization of interspinous implant or bony decompression for treatment of spinal stenosis related intermittent neurogenic claudication.
- Author
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Moojen, Wouter A., Arts, Mark P., Brand, Ronald, Koes, Bart W., and Peul, Wilco C.
- Subjects
- *
BONE density , *MUSCULOSKELETAL system , *BODY composition , *CLINICAL trials , *HOSPITAL admission & discharge - Abstract
Background: Decompressive laminotomy is the standard surgical procedure in the treatment of patients with canal stenosis related intermittent neurogenic claudication. New techniques, such as interspinous process implants, claim a shorter hospital stay, less post-operative pain and equal long-term functional outcome. A comparative (cost-) effectiveness study has not been performed yet. This protocol describes the design of a randomized controlled trial (RCT) on (cost-) effectiveness of the use of interspinous process implants versus conventional decompression surgery in patients with lumbar spinal stenosis. Methods/Design: Patients (age 40-85) presenting with intermittent neurogenic claudication due to lumbar spinal stenosis lasting more than 3 months refractory to conservative treatment, are included. Randomization into interspinous implant surgery versus bony decompression surgery will take place in the operating room after induction of anesthesia. The primary outcome measure is the functional assessment of the patient measured by the Zurich Claudication Questionnaire (ZCQ), at 8 weeks and 1 year after surgery. Other outcome parameters include perceived recovery, leg and back pain, incidence of re-operations, complications, quality of life, medical consumption, absenteeism and costs. The study is a randomized multi-institutional trial, in which two surgical techniques are compared in a parallel group design. Patients and research nurses are kept blinded of the allocated treatment during the follow-up period of 1 year. Discussion: Currently decompressive laminotomy is the golden standard in the surgical treatment of lumbar spinal stenosis. Whether surgery with interspinous implants is a reasonable alternative can be determined by this trial. Trial register: Dutch Trial register number: NTR1307 [ABSTRACT FROM AUTHOR]
- Published
- 2010
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35. Risk score for Outcome After Allogeneic Hematopoietic Stem Cell Transplantation.
- Author
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Gratwohi, Alois, Stern, Martin, Brand, Ronald, Apperley, Jane, Baldomero, Helen, de Witte, Theo, Dini, Giorgio, Rocha, Vanderson, Passweg, Jakob, Sureda, Anna, Tichelli, André, and Niederwieser, Dietger
- Subjects
- *
HEMATOPOIETIC stem cell transplantation , *DISEASE progression , *HEALTH outcome assessment , *DIAGNOSIS , *BONE marrow cells , *PATIENTS - Abstract
The article examines the European Group for Blood and Marrow Transplantation risk score for outcome after allogeneic hematopoietic stem cell transplantation. It is stated that age of patients, disease stage, time interval from diagnosis to transplant, donor type and donor-recipient sex combination were used to established a score from 0 to 7 points.
- Published
- 2009
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36. Timing of surgery for sciatica: subgroup analysis alongside a randomized trial.
- Author
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Peul, Wilco C., Arts, Mark P., Brand, Ronald, and Koes, Bart W.
- Subjects
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SCIATICA , *SCIATIC nerve diseases , *PAIN management , *SURGERY , *SURGICAL therapeutics - Abstract
Surgery speeds up recovery for sciatica. Prolonged conservative care with surgery for those patients with persistent sciatica however, yields similar results at 1 year. To investigate whether baseline variables modify the difference in recovery rates between these treatment strategies, baseline data of 283 patients enrolled in a randomized trial, comparing early surgery with prolonged conservative care, were used to analyse effect modification of the allotted treatment strategy. For predictors shown to modify the effect of the treatment strategy, repeated measurement analyses with the Roland Disability Questionnaire and visual analogue scale pain as continuous outcomes were performed for every level of that predictor. Presumed predictive variables did not have any interaction with treatment, while “sciatica provoked by sitting” showed to be a significant effect modifier ( P = 0.07). In a Cox model we estimated a hazard ratio (HR, surgery versus conservative) of 2.2 (95% CI 1.7–3.0) in favour of surgery when sciatica was provoked by sitting, while the HR was 1.3 (95% CI 0.8–2.2) when this sign was absent. The interaction effect is marginally significant (interactions are usually tested at the 10% level) but the patterns generated by the repeated measurement analyses of all primary outcomes are completely consistent with the inferred pattern from the survival analysis. Classical signs did not show any contribution as decision support tools in deciding when to operate for sciatica, whereas treatment effects of early surgery are emphasized when sciatica is provoked by sitting and negligible when this symptom is absent. [ABSTRACT FROM AUTHOR]
- Published
- 2009
- Full Text
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37. Effectiveness of percutaneous laser disc decompression versus conventional open discectomy in the treatment of lumbar disc herniation; design of a prospective randomized controlled trial.
- Author
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Brouwer, Patrick A., Peul, Wilco C., Brand, Ronald, Arts, Mark P., Koes, Bart W., Van den Berg, Annette A., and Van Buchem, Mark A.
- Subjects
- *
SCIATICA , *DISCECTOMY , *NEUROSURGERY , *MUSCULOSKELETAL system diseases , *THERAPEUTICS - Abstract
Background: The usual surgical treatment of refractory sciatica caused by lumbar disc herniation, is open discectomy. Minimally invasive procedures, including percutaneous therapies under local anesthesia, are increasingly gaining attention. One of these treatments is Percutaneous Laser Disc Decompression (PLDD). This treatment can be carried out in an outpatient setting and swift recovery and return to daily routine are suggested. Thus far, no randomized trial into cost-effectiveness of PLDD versus standard surgical procedure has been performed. We present the design of a randomized controlled trial, studying the cost-effectiveness of PLDD versus conventional open discectomy in patients with sciatica from lumbar disc herniation. Methods/design: The study is a randomized prospective multi-center trial, in which two treatment strategies are compared in a parallel group design. Patients (age 18-70 years) visiting the neurosurgery department of the participating hospitals, are considered for inclusion in the trial when sciatica due to lumbar disc herniation has lasted more than 8 weeks. Patients with disc herniation smaller than 1/3 of the spinal canal diameter, without concomitant lateral recess stenosis or sequestration, are eligible for participation, and are randomized into one of two treatment arms; either Percutaneous Laser Disc Decompression or conventional discectomy. The functional outcome of the patient, as assessed by the Roland Disability Questionnaire for Sciatica at 8 weeks and 1 year after treatment, is the primary outcome measure. The secondary outcome parameters are recovery as perceived by the patient, leg and back pain, incidence of re-intervention, complications, quality of life, medical consumption, absence of work and secondary costs. Discussion: Open discectomy is still considered to be the golden standard in the surgical treatment of lumbar disc herniation. Whether Percutaneous Laser Disc Decompression has at least as much efficacy as the standard surgical procedure, and is more cost-effective, will be determined by this trial. Trial registration: Current Controlled Trials ISRCTN25884790. [ABSTRACT FROM AUTHOR]
- Published
- 2009
- Full Text
- View/download PDF
38. Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation: two year results of a randomised controlled trial.
- Author
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Peul, Wilco C., van den Hout, Wilbert B., Brand, Ronald, Thomeer, Ralph T.W.M., and Koes, Bart W.
- Subjects
- *
HEALTH outcome assessment , *SCIATICA treatment , *INTERVERTEBRAL disk hernias , *SPINE abnormalities , *SURGERY , *THERAPEUTICS - Abstract
Objectives To evaluate the effects of early lumbar disc surgery compared with prolonged conservative care for patients with sciatica over two years of follow-up. Design Randomised controlled trial. Setting Nine Dutch hospitals. Participants 283 patients with 6-12 weeks of sciatica. Interventions Early surgery or an intended six months of continued conservative treatment, with delayed surgery if needed. Main outcome measures Scores from Roland disability questionnaire For sciatica, visual analogue scale for leg pain, and Likert self rating scale of global perceived recovery. Results Of the 141 patients assigned to undergo early surgery, 125 (89%) underwent microdiscectomy. Of the 142 patients assigned to conservative treatment, 62 (44%) eventually required surgery, seven doing so in the second year of follow-up. There was no significant overall difference between treatment arms in disability scores during the first two years (P=0.25). Improvement in leg pain was faster for patients randomised to early surgery, with a significant difference between "areas under the curves" over two years (P=0.05). This short term benefit of early surgery was no longer significant by six months and continued to narrow between six months and 24 months. Patient satisfaction decreased slightly between one and two years for both groups. At two years 20% of all patients reported an unsatisfactory outcome. Conclusions Early surgery achieved more rapid relief of sciatica than conservative care, but outcomes were similar by one year and these did not change during the second year. [ABSTRACT FROM AUTHOR]
- Published
- 2008
39. Profiling quality of care for patients with chronic headache in three different German hospitals -- a case study.
- Author
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Melchart, Dieter, Wessel, Anne, Brand, Ronald, Hager, Stefan, and Weidenhammer, Wolfgang
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HEADACHE , *MEDICAL quality control , *REHABILITATION services in hospitals , *PATIENTS - Abstract
Background: Legal requirements for quality assurance in German rehabilitation hospitals include comparisons of providers. Objective is to describe and to compare outcome quality of care offered by three hospitals providing in-patient rehabilitative treatment exemplified for patients with chronic headache. Methods: We performed a prospective three center observational study on patients suffering from chronic headache. Patients underwent interventions commonly used according to internal guidelines of the hospitals. Measurements were taken at three points in time (at admission, at discharge and 6 months after discharge). Indicators of outcome quality included pain intensity and frequency of pain, functional ability, depression, quality of life and health related behavior. Analyses of differences amongst the hospitals were adjusted by covariates due to case-mix situation. Results: 306 patients from 3 hospitals were included in statistical analysis. Amongst the hospitals, patients differed significantly in age, education, diagnostic subgroups, beliefs, and with respect to some pain-related baseline values (covariates). Patients in all three hospitals benefited from intervention to a clinically relevant degree. At discharge from hospital, outcome quality differed significantly after adjustment according to case-mix only in terms of patients' global assessment of treatment results. Six months after discharge, the only detectable significant differences were for secondary outcomes like improved coping with stress or increased use of self-help. The profiles for satisfaction with the hospital stay showed clear differences amongst patients. Conclusion: The results of this case study do not suggest a definite overall ranking of the three hospitals that were compared, but outcome profiles offer a multilayer platform of reliable information which might facilitate decision making. [ABSTRACT FROM AUTHOR]
- Published
- 2008
- Full Text
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40. Cost-effectiveness of decompression according to Gill versus instrumented spondylodesis in the treatment of sciatica due to low grade spondylolytic spondylolisthesis: A prospective randomised controlled trial [NTR1300].
- Author
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Arts, Mark P., Verstegen, Marco J. T., Brand, Ronald, Koes, Bart W., van den Akker, M. Elske, and Peul, Wilco C.
- Subjects
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COST effectiveness , *DECOMPRESSION (Physiology) , *SPONDYLOLISTHESIS , *HEALTH outcome assessment , *RANDOMIZED controlled trials , *THERAPEUTICS - Abstract
Background: Nerve root decompression with instrumented spondylodesis is the most frequently performed surgical procedure in the treatment of patients with symptomatic low-grade spondylolytic spondylolisthesis. Nerve root decompression without instrumented fusion, i.e. Gill's procedure, is an alternative and less invasive approach. A comparative cost-effectiveness study has not been performed yet. We present the design of a randomised controlled trial on cost-effectiveness of decompression according to Gill versus instrumented spondylodesis. Methods/design: All patients (age between 18 and 70 years) with sciatica or neurogenic claudication lasting more than 3 months due to spondylolytic spondylolisthesis grade I or II, are eligible for inclusion. Patients will be randomly allocated to nerve root decompression according to Gill, either unilateral or bilateral, or pedicle screw fixation with interbody fusion. The main primary outcome measure is the functional assessment of the patient measured with the Roland Disability Questionnaire for Sciatica at 12 weeks and 2 years. Other primary outcome measures are perceived recovery and intensity of leg pain and low back pain. The secondary outcome measures include, incidence of re-operations, complications, serum creatine phosphokinase, quality of life, medical consumption, costs, absenteeism, work perception, depression and anxiety, and treatment preference. The study is a randomised prospective multicenter trial in which two surgical techniques are compared in a parallel group design. Patients and research nurse will not be blinded during the follow-up period of 2 years. Discussion: Currently, nerve root decompression with instrumented fusion is the golden standard in the surgical treatment of low-grade spondylolytic spondylolisthesis, although scientific proof justifying instrumented spondylodesis over simple decompression is lacking. This trial is designed to elucidate the controversy in best surgical treatment of symptomatic patients with low-grade spondylolytic spondylolisthesis. [ABSTRACT FROM AUTHOR]
- Published
- 2008
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- View/download PDF
41. Bed-sharing in the first four months of life: a risk factor for sudden infant death.
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Ruys, Jan H., de Jonge, Guus A., Brand, Ronald, Engelberts, Adèle C., and Semmekrot, Ben A.
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SUDDEN infant death syndrome , *INFANT death , *BREASTFEEDING , *INFANT nutrition , *SYNDROMES in children , *MOTHER-infant relationship - Abstract
Aim: To investigate the risk of sudden infant death in the Netherlands during bed-sharing in the first half year of life and the protective effect of breastfeeding on it. Methods: During a 10-year period between September 1996 and September 2006 nationwide, 213 cot deaths were investigated. Results and discussion: Of 138 cot deaths of less than 6 months of age, 36 (26%) bed-shared. In a reference group of 1628 babies from infant welfare centres only 9.4% were bed-sharing in the night prior to the interview. After correction for smoking of one or both parents the odds ratio for cot death during bed-sharing with parents decreased with age from 9.1 (CI 4.2–19.4) at 1 month, to 4.0 (CI 2.3–6.7) at 2 months, to 1.7 (CI 0.9–3.4) at 3 months and to 1.3 (CI 1.0–1.6) at 4 through 5 months of age. The excess risk (OR > 1) associated with bed-sharing is itself not significantly influenced by the presence or absence of breastfeeding. Conclusion: Bed-sharing is a serious risk factor for sudden infant death for all babies of less than 4 months of age. From 4 months onwards bed-sharing did not contribute significantly to the risk of cot death anymore in our study. [ABSTRACT FROM AUTHOR]
- Published
- 2007
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42. Cost-effectiveness of microendoscopic discectomy versus conventional open discectomy in the treatment of lumbar disc herniation: a prospective randomised controlled trial [ISRCTN51857546].
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Arts, Mark P., Peul, Wilco C., Brand, Ronald, Koes, Bart W., and Thomeer, Ralph T. W. M.
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DISCECTOMY , *INTERVERTEBRAL disk surgery , *CHRONIC diseases , *MUSCULOSKELETAL system diseases , *MUSCULOSKELETAL system abnormalities , *MUSCULOSKELETAL emergencies , *THERAPEUTICS - Abstract
Background: Open discectomy is the standard surgical procedure in the treatment of patients with long-lasting sciatica caused by lumbar disc herniation. Minimally invasive approaches such as microendoscopic discectomy have gained attention in recent years. Reduced tissue trauma allows early ambulation, short hospital stay and quick resumption of daily activities. A comparative costeffectiveness study has not been performed yet. We present the design of a randomised controlled trial on cost-effectiveness of microendoscopic discectomy versus conventional open discectomy in patients with lumbar disc herniation. Methods/Design: Patients (age 18-70 years) presenting with sciatica due to lumbar disc herniation lasting more than 6-8 weeks are included. Patients with disc herniation larger than 1/3 of the spinal canal diameter, or disc herniation less than 1/3 of the spinal canal diameter with concomitant lateral recess stenosis or sequestration, are eliglible for participation. Randomisation into microendoscopic discectomy or conventional unilateral transflaval discectomy will take place in the operating room after induction of anesthesia. The length of skin incision is equal in both groups. The primary outcome measure is the functional assessment of the patient, measured by the Roland Disability Questionnaire for Sciatica, at 8 weeks and 1 year after surgery. We will also evaluate several other outcome parameters, including perceived recovery, leg and back pain, incidence of re-operations, complications, serum creatine kinase, quality of life, medical consumption, absenteeism and costs. The study is a randomised prospective multi-institutional trial, in which two surgical techniques are compared in a parallel group design. Patients and research nurses are kept blinded of the allocated treatment during the follow-up period of 2 years. Discussion: Currently, open discectomy is the golden standard in the surgical treatment of lumbar disc herniation. Whether microendoscopic discectomy is more cost-effective than unilateral transflaval discectomy has to be determined by this trial. [ABSTRACT FROM AUTHOR]
- Published
- 2006
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43. Changes in perinatal care and survival in very preterm and extremely preterm infants in The Netherlands between 1983 and 1995
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Anthony, Sabine, Ouden, Lya den, Brand, Ronald, Verloove-Vanhorick, Pauline, and Gravenhorst, Jack Bennebroek
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NEONATAL intensive care , *NEWBORN infant care , *CESAREAN section , *MATERNAL health services , *CAUSES of death , *MULTIVARIATE analysis , *NEONATAL intensive care units , *ACQUISITION of data , *DISEASE incidence , *RETROSPECTIVE studies , *LOW birth weight , *RISK assessment , *SURVIVAL analysis (Biometry) , *INFANT mortality , *APGAR score , *LOGISTIC regression analysis , *PROBABILITY theory - Abstract
Objective: To evaluate changes in obstetrical and neonatal care for very preterm and extremely preterm infants between 1983 and 1995 in The Netherlands and to evaluate the effect of those changes. Study design: Data on all very preterm or VLBW infants from the linked national obstetrical and neonatal databases of 1995 (
N=2066 ) were compared to data on similar infants from a nation-wide study of very preterm infants born in 1983 (N=1338 ). Results: Obstetrical and neonatal management changed over time, with an increased number of deliveries in tertiary centres (35.7–60.7%), an increase in C-sections (43.7–56.8%) and prolonged artificial ventilation (3.4–9.5%). Survival until discharge increased from 75 to 90% and neonatal morbidity decreased in relative terms. Conclusions: The short-term outcome for these very preterm and extremely preterm infants has improved. Long-term follow-up through to school age and adulthood of preterm infants is needed to investigate the changes in the sequelae of intensive obstetrical and neonatal care. [Copyright &y& Elsevier]- Published
- 2004
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44. Term breech presentation in The Netherlands from 1995 to 1999: mortality and morbidity in relation to the mode of delivery of 33,824 infants
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Rietberg, Christine C.Th., Elferink-Stinkens, Patty M., Brand, Ronald, van Loon, Aren J., Van Hemel, Oscar J.S., and Visser, Gerard H.A.
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BREECH delivery , *FETAL presentation , *INFANT death , *CESAREAN section , *LABOR complications (Obstetrics) - Abstract
: ObjectiveTo analyse neonatal mortality and morbidity in term infants born in breech presentation in relation to the mode of delivery (planned caesarean section, emergency caesarean section or vaginal delivery) and to compare these findings with those of the Term Breech Trial Collaborative Group [Hannah et al. Lancet 2000; October].: DesignRetrospective observational study.: SettingThe Netherlands.: PopulationInfants (n = 33,824) born at term in breech presentation in the Netherlands between 1995 and 1999. Multiple pregnancies, antenatal death and major congenital malformations were excluded.: MethodsData derived from the Dutch Perinatal Database were used to compare neonatal outcome of infants born in breech presentation in relation to the different modes of delivery (i.e. planned caesarean section, emergency caesarean section and vaginal delivery). Correction was made for differences in parity, duration of gestation and birthweight, using logistic regression.: Main outcome measuresIntrapartum and first-week neonatal death, 5 minute Apgar score and birth trauma.: ResultsVaginal delivery and emergency caesarean section resulted in a sevenfold increase in low Apgar score, a threefold increase in birth trauma and a twofold increase in perinatal mortality when compared with the results of planned caesarean section.: ConclusionsThis study confirms the data found by Hannah et al. on an increase in early neonatal morbidity and mortality, following a trial of labour in cases of term breech presentation. These data require carefully weighed consideration against increased maternal (long term) risks due to a rise in caesarean sections. [Copyright &y& Elsevier]
- Published
- 2003
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45. Prospective study of renal insufficiency after bone marrow transplantation.
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Kist-van Holthe, Joana E., Goedvolk, Charlotte A., Brand, Ronald, van Weel, Margreet H., Bredius, Robbert M., van Oostayen, Jacques A., Vossen, Jacques J., and van der Heijden, Bert J.
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CHRONIC kidney failure in children , *BONE marrow transplantation - Abstract
Since more and more children survive allogeneic bone marrow transplantation (BMT), knowledge of acute and late complications becomes increasingly important. Besides the major complications [(opportunistic) infections, veno-occlusive disease, graft versus host disease, and recurrence of primary disease], acute and chronic renal insufficiency are significant post-transplant complications that may contribute to transplant-related mortality. To elucidate risk factors for acute and chronic renal insufficiency post BMT, we performed a prospective study of all 66 children who received a BMT in a 2-year period at our institution; 21% had acute renal insufficiency post BMT. Risk factors for acute renal insufficiency were veno-occlusive disease, high cyclosporin serum levels, and foscarnet therapy. Of surviving patients, 11% developed chronic renal insufficiency 1 year post BMT. Acute renal insufficiency was the sole predictor of chronic renal insufficiency. In contrast to studies in adults, we did not find total body irradiation to be a risk factor for chronic renal insufficiency. Future long-term studies are needed to assess incidence and morbidity of chronic renal insufficiency in children following allogeneic BMT. [ABSTRACT FROM AUTHOR]
- Published
- 2002
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46. Gender influences the birth order effect in HLA-identical stem cell transplantation.
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Dierselhuis, Miranda P., Spierings, Eric, Brand, Ronald, Hendriks, Matthijs, Canossi, Angelica, Dolstra, Harry, Eliaou, Joan-Francois, Enczmann, Jurgen, Gervais, Thibaut, Kircher, Brigitte, Laurin, David, Loiseau, Pascale, Sergeant, Ruhena, and Goulmy, Els
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STEM cell transplantation , *GENDER , *BIRTH order , *HLA histocompatibility antigens , *PREGNANCY , *CORD blood , *ANTIGENS - Abstract
The article reports on the stem cell transplant (SCT) outcome with younger sibling donors (YSD) which may explain by transmaternal cell flow pregnancy. It notes that cord blood comprises of minor H antigen which experienced T cells that are not directed against maternal minor H antigens. It indicates a study that gender influences the birth order effect of human leukocyte antigen (HLA)-identical stem cell transplantation.
- Published
- 2013
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47. For debate: Pet birds as an independent risk factor for lung cancer.
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Holst, Peter A., Kromhout, Daan, and Brand, Ronald
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LUNG cancer , *CAGE birds , *CAROTENES - Abstract
Focuses on the risk factor of pet birds for lung cancer in Netherlands. Factors contributing to the incidence of lung cancer; Classifications of tumours according to World Health Organization criteria; Calculation on the intake of B carotene and vitamin C.
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- 1988
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48. Should the standard dimethyl sulfoxide concentration be reduced? Results of a European Group for Blood and Marrow Transplantation prospective noninterventional study on usage and side effects of dimethyl sulfoxide.
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Morris, Curly, Wreede, Liesbeth, Scholten, Marijke, Brand, Ronald, Biezen, Anja, Sureda, Anna, Dickmeiss, Ebbe, Trneny, Marek, Apperley, Jane, Chiusolo, Patrizia, Imhoff, Gustaaf W., Lenhoff, Stig, Martinelli, Giovanni, Hentrich, Marcus, Pabst, Thomas, Onida, Francesco, Quinn, Michael, Kroger, Nicolaus, Witte, Theo, and Ruutu, Tapani
- Subjects
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DIMETHYL sulfoxide , *BLOOD transfusion , *BONE marrow transplantation , *CELL preservation , *STEM cells , *THERAPEUTICS - Abstract
Background Dimethyl sulfoxide ( DMSO) is essential for the preservation of liquid nitrogen-frozen stem cells, but is associated with toxicity in the transplant recipient. Study Design and Methods In this prospective noninterventional study, we describe the use of DMSO in 64 European Blood and Marrow Transplant Group centers undertaking autologous transplantation on patients with myeloma and lymphoma and analyze side effects after return of DMSO-preserved stem cells. Results While the majority of centers continue to use 10% DMSO, a significant proportion either use lower concentrations, mostly 5 or 7.5%, or wash cells before infusion (some for selected patients only). In contrast, the median dose of DMSO given (20 mL) was much less than the upper limit set by the same institutions (70 mL). In an accompanying statistical analysis of side effects noted after return of DMSO-preserved stem cells, we show that patients in the highest quartile receiving DMSO ( mL and mL/kg body weight) had significantly more side effects attributed to DMSO, although this effect was not observed if DMSO was calculated as mL/min. Dividing the myeloma and lymphoma patients each into two equal groups by age we were able to confirm this result in all but young myeloma patients in whom an inversion of the odds ratio was seen, possibly related to the higher dose of melphalan received by young myeloma patients. Conclusion We suggest better standardization of preservation method with reduced DMSO concentration and attention to the dose of DMSO received by patients could help reduce the toxicity and morbidity of the transplant procedure. [ABSTRACT FROM AUTHOR]
- Published
- 2014
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49. Recovery of motor deficit accompanying sciatica--subgroup analysis of a randomized controlled trial.
- Author
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Overdevest, Gijsbert M., Vleggeert-Lankamp, Carmen L. A. M., Jacobs, Wilco C. H., Brand, Ronald, Koes, Bart W., and Peul, Wilco C.
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MOVEMENT disorders , *HERNIA , *SYMPTOMS , *PARALYSIS , *MEDICAL statistics , *RANDOMIZED controlled trials - Abstract
Background context In patients with sciatica due to a lumbar disc herniation, it is generally recommended to reserve surgical treatment for those who suffer from intolerable pain or those who demonstrate persistent symptoms after conservative management. Controversy exists about the necessity of early surgical intervention for those patients that have an additional motor deficit. Purpose The aim of this study was to compare the recovery of motor deficit among patients receiving early surgery to those receiving prolonged conservative treatment. Study design Subgroup analysis of a randomized controlled trial. Patient sample This subgroup analysis focuses on 150 (53%) of 283 patients with sciatica due to a lumbar disc herniation and whose symptoms at baseline (before randomization) were accompanied by a motor deficit. Outcome measures Motor deficit was assessed through manual muscle testing and graded according to the Medical Research Council (MRC) scale. Methods In total, 150 patients with 6 to 12 weeks of sciatica due to a lumbar disc herniation and whose symptoms were accompanied by a moderate (MRC Grade 4) or severe (MRC Grade 3) motor deficit were randomly allocated to early surgery or prolonged conservative treatment. Repeated standardized neurologic examinations were performed at baseline and at 8, 26, and 52 weeks after randomization. This study was supported by a grant from the Netherlands Organization for Health Research and Development (ZonMW) and the Hoelen Foundation The Hague. Results Sciatica recovered among seven (10%) of the 70 patients assigned to early surgery before surgery could be performed, and of the 80 patients assigned to conservative treatment, 32 patients (40%) were treated surgically because of intolerable pain. Baseline severity of motor deficit was graded moderate in 84% of patients and severe in 16% of patients. Motor deficit recovered significantly faster among patients allocated to early surgery (p=.01), but the difference was no longer significant at 26 (p=.21) or 52 weeks (p=.92). At 1 year, complete recovery of motor deficit was found in 81% of patients allocated to early surgery and in 80% of patients allocated to prolonged conservative treatment. Perceived overall recovery of sciatica was directly related to the presence of an accompanying motor deficit. Severe motor deficit at baseline (odds ratio, 5.4; confidence interval, 1.7-17.4) and a lumbar disc herniation encompassing ≥25% of the cross-sectional area of the spinal canal (odds ratio, 6.4; confidence interval, 1.3-31.8) were the most important risk factors for persistent deficit at 1 year. Conclusions Early surgery resulted in a faster recovery of motor deficit accompanying sciatica compared with prolonged conservative treatment but the difference was no longer significant during the final follow-up examination at 1 year. [ABSTRACT FROM AUTHOR]
- Published
- 2014
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50. Patient Blood Management in Elective Total Hip- and Knee-replacement Surgery (Part 1): A Randomized Controlled Trial on Erythropoietin and Blood Salvage as Transfusion Alternatives Using a Restrictive Transfusion Policy in Erythropoietin-eligible Patients.
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So-Osman, Cynthia, Nelissen, Rob G H H, Koopman-van Gemert, Ankie W M M, Kluyver, Ewoud, Pöll, Ruud G, Onstenk, Ron, Van Hilten, Joost A, Jansen-Werkhoven, Thekla M, van den Hout, Wilbert B, Brand, Ronald, and Brand, Anneke
- Abstract
BACKGROUND: Patient blood management combines the use of several transfusion alternatives. Integrated use of erythropoietin, cell saver, and/or postoperative drain reinfusion devices on allogeneic erythrocyte use was evaluated using a restrictive transfusion threshold. METHODS: In a factorial design, adult elective hip- and knee-surgery patients with hemoglobin levels 10 to 13 g/dl (n = 683) were randomized for erythropoietin or not, and subsequently for autologous reinfusion by cell saver or postoperative drain reinfusion devices or for no blood salvage device. Primary outcomes were mean allogeneic intra- and postoperative erythrocyte use and proportion of transfused patients (transfusion rate). Secondary outcome was cost-effectiveness. RESULTS: With erythropoietin (n = 339), mean erythrocyte use was 0.50 units (U)/patient and transfusion rate 16% while without (n = 344), these were 0.71 U/patient and 26%, respectively. Consequently, erythropoietin resulted in a nonsignificant 29% mean erythrocyte reduction (ratio, 0.71; 95% CI, 0.42 to 1.13) and 50% reduction of transfused patients (odds ratio, 0.5; 95% CI, 0.35 to 0.75). Erythropoietin increased costs by 785 per patient (95% CI, 262 to 1,309), that is, 7,300 per avoided transfusion (95% CI, 1,900 to 24,000). With autologous reinfusion, mean erythrocyte use was 0.65 U/patient and transfusion rate was 19% with erythropoietin (n = 214) and 0.76 U/patient and 29% without (n = 206). Compared with controls, autologous blood reinfusion did not result in erythrocyte reduction and increased costs by 537 per patient (95% CI, 45 to 1,030). CONCLUSIONS: In hip- and knee-replacement patients (hemoglobin level, 10 to 13 g/dl), even with a restrictive transfusion trigger, erythropoietin significantly avoids transfusion, however, at unacceptably high costs. Autologous blood salvage devices were not effective. [ABSTRACT FROM AUTHOR]
- Published
- 2014
- Full Text
- View/download PDF
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