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Experiences of neurological surgeons with malpractice lawsuits

Pravesh S. Gadjradj, Julian B. Ghobrial, and Biswadjiet S. Harhangi

OBJECTIVE

As a specialty that treats acute pathology and refractory pain, neurosurgery is at risk for high liability, making the practice of defensive medicine quite common. The extent to which the practice of defensive medicine is linked to experience with malpractice lawsuits remains unclear. The aims of this study were to clarify this by surveying neurosurgeons about the frequency of experiencing medical lawsuits and to show how neurosurgeons reflect on facing such lawsuits.

METHODS

A survey consisting of 24 questions was distributed among members of the Congress of Neurological Surgeons. The survey consisted of four parts: 1) demographics of participants; 2) the way malpractice lawsuits affect the way respondents practice medicine; 3) experiences with medical malpractice lawsuits; and 4) the effect of the medical malpractice environment on one’s own practice of medicine.

RESULTS

There were a total of 490 survey respondents, 83.5% of whom were employed in the US. Of the respondents, 39.5% stated they were frequently or always concerned about being sued, and 77.4% stated their fear had led to a change in how they practice medicine. For 58.4%, this change led to the practice of defensive medicine, while for others it led to more extensive documentation (14.3%) and/or to referring or dropping complex cases (12.4%).

Among the respondents, 80.9% at some time were named in a medical malpractice lawsuit and 12.3% more than 10 times. The main concerns expressed about being sued included losing confidence and practicing defensive medicine (17.8%), personal assets being at risk (16.9%), and being named in the National Practitioner Data Bank (15.6%). Given the medical malpractice environment, 58.7% of respondents considered referring complex patient cases, whereas 36.5% considered leaving the practice of medicine. The fear of being sued (OR 4.06, 95% CI 2.53–6.51) and the consideration of limiting the scope of practice (OR 3.08, 1.80–5.20) were both independently associated with higher odds of considering leaving the practice of medicine.

CONCLUSIONS

The current medicolegal landscape has a profound impact on neurosurgical practice. The fear of being sued, the financial aspects of practicing defensive medicine, and the proportion of neurosurgeons who are considering leaving the practice of medicine emphasize the need for a shift in the medicolegal landscape to a system in which fear of being sued does not play a dominant role and the interests of patients are protected.

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Current practice of cervical disc arthroplasty: a survey among 383 AOSpine International members

Timothy C. Chin-See-Chong, Pravesh S. Gadjradj, Robert J. Boelen, and Biswadjiet S. Harhangi

OBJECTIVE

The use of cervical disc arthroplasty (CDA) in spinal practice is controversial. This may be explained by the lack of studies with a large sample size and long-term outcomes. With this survey the authors aimed to evaluate the opinions of spine surgeons on the use of CDA in the current treatment of cervical disc herniation (CDH).

METHODS

A web-based survey was sent to all members of AOSpine International by email using SurveyMonkey on July 18, 2016. A single reminder was sent on August 18, 2016. Questions included geographic location; specialty; associated practice model; number of discectomies performed annually; the use of CDA, anterior cervical discectomy (ACD), and anterior cervical discectomy and fusion (ACDF); and the expectations for clinical outcomes of these procedures.

RESULTS

A total of 383 questionnaires were analyzed. Almost all practitioners (97.9%) were male, with a mean of 15.0 ± 9.7 years of clinical experience. The majority of responders were orthopedic surgeons (54.6%). 84.3% performed ACDF as the standard technique for CDH. 47.8% of the surgeons occasionally used CDA, whereas 7.3% used CDA as standard approach for CDH. The most common arthroplasty device used was the ProDisc-C. Low evidence for benefits and higher costs were the most important reasons for not offering CDA. The risk of adjacent-level disease was considered smaller for CDA as compared with ACDF. However, ACDF was expected to have the highest effectiveness on arm pain (87.5%), followed by CDA (77.9%), while ACD had the least (12.6%).

CONCLUSIONS

In this survey, CDA was not considered to be the routine procedure to treat CDH. Reported benefits included the reduced risk of adjacent-level disease and preservation of motion of the neck. Lack of enough evidence on its effectiveness as well as higher costs were considered to be disadvantages of CDA. More research should be conducted on the implementation impact of CDA and the cost-effectiveness from society's perspective.

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Clinical outcomes after percutaneous transforaminal endoscopic discectomy for lumbar disc herniation: a prospective case series

Pravesh S. Gadjradj, Maurits W. van Tulder, Clemens M. F. Dirven, Wilco C. Peul, and B. Sanjay Harhangi

OBJECTIVE

Throughout the last decades, full-endoscopic techniques to treat lumbar disc herniation (LDH) have gained popularity in clinical practice. To date, however, no Class I evidence on the efficacy of percutaneous transforaminal endoscopic discectomy (PTED) has been published, and studies describing its safety and short- and long-term efficacy are scarce. In this study the authors aimed to evaluate the clinical outcomes and safety in patients undergoing PTED for LDH.

METHODS

Patients who underwent PTED for LDH between January 2009 and December 2012 were prospectively followed. The primary outcomes were the visual analog scale (VAS) score for leg pain and the score on the Quebec Back Pain Disability Scale (QBPDS). Secondary outcomes were the perceived experience with the local anesthesia used and satisfaction with the results after 1 year using Likert-type scales. The pretreatment means were compared with the means obtained 6 and 52 weeks after surgery using paired t-tests.

RESULTS

A total of 166 patients underwent surgery for a total of 167 LDHs. The mean duration of surgery (± SD) was 51.0 ± 9.0 minutes. The 1-year follow-up rate was 95.2%. The mean reported scores on the VAS and QBPDS were 82.5 ± 17.3 mm and 60.0 ± 18.4 at baseline, respectively. Six weeks after surgery, the scores on the VAS and QBPDS were significantly reduced to 28.8 ± 24.5 mm and 26.7 ± 20.6, respectively (p < 0.001). After 52 weeks of follow-up, the scores were further reduced compared with baseline scores (p < 0.001) to 19.6 ± 23.5 mm on the VAS and 20.2 ± 18.1 on the QBPDS. A total of 4 complications were observed, namely 1 dural tear, 1 deficit of ankle dorsiflexion, and 2 cases of transient paresis in the foot due to the use of local anesthetics.

CONCLUSIONS

PTED appears to be a safe and effective intervention for LDH and has similar clinical outcomes compared to conventional open microdiscectomy. High-quality randomized controlled trials are required to study the efficacy and cost-effectiveness of PTED.

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A novel noninstrumented surgical approach for foramen reconstruction for isthmic spondylolisthesis in patients with radiculopathy: preliminary clinical and radiographic outcomes

Jochem K. H. Spoor, Alof H. G. Dallenga, Pravesh S. Gadjradj, Luuk de Klerk, Frans C. van Biezen, Henk W. C. Bijvoet, and Biswadjiet S. Harhangi

OBJECTIVE

The health care costs for instrumented spine surgery have increased dramatically in the last few decades. The authors present a novel noninstrumented surgical approach for patients with isthmic spondylolisthesis, with clinical and radiographic results.

METHODS

Charts of patients who underwent this technique were reviewed. The procedure consisted of nerve root decompression by reconstruction of the intervertebral foramen. This was achieved by removal of the pedicle followed by noninstrumented posterolateral fusion in which autologous bone graft from the right iliac crest was used. Outcomes regarding radicular complaints, bony fusion, progression of the slip, and complications were evaluated using patient history and radiographs obtained at follow-up intervals of 3–18 months after surgery.

RESULTS

A total of 58 patients with a mean age of 47 years were treated with this method. Partial removal of the pedicle was performed in 93.1% of the cases, whereas in 6.9% of the cases the entire pedicle was removed. The mean duration of surgery was 216.5 ± 54.5 minutes (range 91–340 minutes). The mean (± SD) duration of hospitalization was 10.1 ± 2.9 days (range 5–18 days).

After 3 months of follow-up, 86% of the patients reported no leg pain, and this dropped to 81% at last follow-up. Radiographic follow-up showed bony fusion in 87.7% of the patients. At 1 year, 5 patients showed progression of the slip, which in 1 patient prompted a second operation within 1 year. No major complications occurred.

CONCLUSIONS

Treatment of isthmic spondylolisthesis by reconstruction of the intervertebral neuroforamen and posterolateral fusion in situ is a safe procedure and has comparable results with the existing techniques. Cost-effectiveness research comparing this technique to conventional instrumented fusion techniques is necessary to evaluate the merits for both patients and society.

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Patient preferences for treatment of lumbar disc herniation: a discrete choice experiment

Pravesh S. Gadjradj, Nicholas V. R. Smeele, Mandy de Jong, Paul R. A. M. Depauw, Maurits W. van Tulder, Esther W. de Bekker-Grob, and Biswadjiet S. Harhangi

OBJECTIVE

Lumbar discectomy is a frequently performed procedure to treat sciatica caused by lumbar disc herniation. Multiple surgical techniques are available, and the popularity of minimally invasive surgical techniques is increasing worldwide. Clinical outcomes between these techniques may not show any substantial differences. As lumbar discectomy is an elective procedure, patients’ own preferences play an important role in determining the procedure they will undergo. The aims of the current study were to determine the relative preference weights patients apply to various attributes of lumbar discectomy, determine if patient preferences change after surgery, identify preference heterogeneity for choosing surgery for sciatica, and calculate patient willingness to pay for other attributes.

METHODS

A discrete choice experiment (DCE) was conducted among patients with sciatica caused by lumbar disc herniation. A questionnaire was administered to patients before they underwent surgery and to an independent sample of patients who had already undergone surgery. The DCE required patients to choose between two surgical techniques or to opt out from 12 choice sets with alternating characteristic levels: waiting time for surgery, out-of-pocket costs, size of the scar, need of general anesthesia, need for hospitalization, effect on leg pain, and duration of the recovery period.

RESULTS

A total of 287 patients were included in the DCE analysis. All attributes, except scar size, had a significant influence on the overall preferences of patients. The effect on leg pain was the most important characteristic in the decision for a surgical procedure (by 44.8%). The potential out-of-pocket costs for the procedure (28.8%), the wait time (12.8%), need for general anesthesia (7.5%), need for hospitalization (4.3%), and the recovery period (1.8%) followed. Preferences were independent of the scores on patient-reported outcome measures and baseline characteristics. Three latent classes could be identified with specific preference patterns. Willingness-to-pay was the highest for effectiveness on leg pain, with patients willing to pay €3133 for a treatment that has a 90% effectiveness instead of 70%.

CONCLUSIONS

Effect on leg pain is the most important factor for patients in deciding to undergo surgery for sciatica. Not all proposed advantages of minimally invasive spine surgery (e.g., size of the scar, no need of general anesthesia) are necessarily perceived as advantages by patients. Spine surgeons should propose surgical techniques for sciatica, not only based on own ability and proposed eligibility, but also based on patient preferences as is part of shared decision making.

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Neurosurgeons’ opinions on the prenatal management of myelomeningocele

Pravesh S. Gadjradj, Jochem K. H. Spoor, Alex J. Eggink, René Wijnen, Jena L. Miller, Mara Rosner, Mari L. Groves, Philip L. J. DeKoninck, Biswadjiet S. Harhangi, Ahmet Baschat, Marie-Lise van Veelen, and Tjeerd H. R. de Jong

OBJECTIVE

Improvements in imaging and surgical technological innovations have led to the increasing implementation of fetal surgical techniques. Open fetal surgery has demonstrated more favorable clinical outcomes in children born with open myelomeningocele (MMC) than those following postnatal repair. However, primarily because of maternal risks but also because of fetal risks, fetal surgery for MMC remains controversial. Here, the authors evaluated the contemporary management of MMC in the hope of identifying barriers and facilitators for neurosurgeons in providing fetal surgery for MMC.

METHODS

An online survey was emailed to members of the Congress of Neurological Surgeons (CNS) and the International Society for Pediatric Neurosurgery (ISPN) in March 2019. The survey focused on 1) characteristics of the respondents, 2) the practice of counseling on and managing prenatally diagnosed MMC, and 3) barriers, facilitators, and expectations of fetal surgery for MMC. Reminders were sent to improve the response rate.

RESULTS

A total of 446 respondents filled out the survey, most (59.2%) of whom specialized in pediatric neurosurgery. The respondents repaired an average of 9.6 MMC defects per year, regardless of technique. Regardless of the departments in which respondents were employed, 91.0% provided postnatal repair of MMC, 13.0% open fetal repair, and 4.9% fetoscopic repair. According to the surgeons, the most important objections to performing open fetal surgery were a lack of cases available to become proficient in the technique (33.8%), the risk of maternal complications (23.6%), and concern for fetal complications (15.2%). The most important facilitators according to advocates of prenatal closure are a decreased rate of shunt dependency (37.8%), a decreased rate of hindbrain herniation (27.0%), and an improved rate of motor function (18.9%). Of the respondents, only 16.9% agreed that open fetal surgery should be the standard of care.

CONCLUSIONS

The survey results showed diversity in the management of patients with MMC. In addition, significant diversity remains regarding fetal surgery for MMC closure. Despite the apparent benefits of open fetal surgery in selected pregnancies, only a minority of centers and providers offer this technique. As a more technically demanding technique that requires multidisciplinary effort with less well-established long-term outcomes, fetoscopic surgery may face similar limited implementation, although the surgery may pose fewer maternal risks than open fetal surgery. Centralization of prenatal treatment to tertiary care referral centers, as well as the use of sophisticated training models, may help to augment the most commonly cited objection to the implementation of prenatal closure, which is the overall limited caseload.

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Contemporary management and outcome of myelomeningocele: the Rotterdam experience

Jochem K. H. Spoor, Pravesh S. Gadjradj, Alex J. Eggink, Philip L. J. DeKoninck, Bart Lutters, Jeroen R. Scheepe, Jetty van Meeteren, Peter C. J. de Laat, Marie Lise van Veelen, and Tjeerd H. R. de Jong

OBJECTIVE

Myelomeningocele (MMC) is the most common form of spina bifida, with a lifelong impact on the quality of life for infants born with this condition. In recent decades, fetal surgery has evolved from an experimental therapy to standard of care for many centers in the world. In this study, the authors aimed to provide an overview of the current management and outcomes for infants with MMC managed at their institution. This then provides a center-specific historical cohort for comparison with future antenatal-treated MMC cases.

METHODS

This is a retrospective, single-institution cohort study including all consecutive MMC cases between January 1, 2000, and June 1, 2018, at Erasmus MC. Outcome data included closure of the defect (location, timing, and surgical parameters), hydrocephalus management, Chiari malformation type II (CMTII) management, incidence of spinal cord tethering and outcome, motor outcomes, and continence.

RESULTS

A total of 93 patients were included with predominantly lumbosacral lesions. Two patients died during follow-up. Hydrocephalus was present in 84%, with a 71% ventriculoperitoneal shunt reoperation rate. Surgery was performed in 12% for a tethered spinal cord at a mean age of 8 years. Decompression surgery was performed in 3 patients for CMTII. Special education in 63% was significantly associated with hydrocephalus (p < 0.015). Nineteen percent of patients were able to walk independently, and 47% were nonambulators. Social continence for urine was obtained in 75% of patients, 4% had fecal incontinence.

CONCLUSIONS

This study provides an overview of current MMC outcomes at the authors’ center and will serve as a historical cohort for comparison with future fetal surgery cases operated on at the center in the coming years. Apart from a relatively low surgical untethering rate, the authors’ outcome data are comparable to those in the literature. Hydrocephalus is highly prevalent in postnatally treated MMC patients; in this study as in much of the literature, hydrocephalus is correlated with a low cognitive function. Fetal surgery for MMC halves the need for shunt treatment in a select group of MMC pregnancies, constituting a major indication for us to undergo the transition to a fetal surgery center. The fetal benefits of open antenatal surgery for MMC are well established, yet long-term data on especially tethered spinal cord are eagerly awaited.

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Normative data of a smartphone app–based 6-minute walking test, test-retest reliability, and content validity with patient-reported outcome measures

Lazar Tosic, Elior Goldberger, Nicolai Maldaner, Marketa Sosnova, Anna M. Zeitlberger, Victor E. Staartjes, Pravesh S. Gadjradj, Hubert A. J. Eversdijk, Ayesha Quddusi, Maria L. Gandía-González, Jamasb Joshua Sayadi, Atman Desai, Luca Regli, Oliver P. Gautschi, and Martin N. Stienen

OBJECTIVE

The 6-minute walking test (6WT) is used to determine restrictions in a subject’s 6-minute walking distance (6WD) due to lumbar degenerative disc disease. To facilitate simple and convenient patient self-measurement, a free and reliable smartphone app using Global Positioning System coordinates was previously designed. The authors aimed to determine normative values for app-based 6WD measurements.

METHODS

The maximum 6WD was determined three times using app-based measurement in a sample of 330 volunteers without previous spine surgery or current spine-related disability, recruited at 8 centers in 5 countries (mean subject age 44.2 years, range 16–91 years; 48.5% male; mean BMI 24.6 kg/m2, range 16.3–40.2 kg/m2; 67.9% working; 14.2% smokers). Subjects provided basic demographic information, including comorbidities and patient-reported outcome measures (PROMs): visual analog scale (VAS) for both low-back and lower-extremity pain, Core Outcome Measures Index (COMI), Zurich Claudication Questionnaire (ZCQ), and subjective walking distance and duration. The authors determined the test-retest reliability across three measurements (intraclass correlation coefficient [ICC], standard error of measurement [SEM], and mean 6WD [95% CI]) stratified for age and sex, and content validity (linear regression coefficients) between 6WD and PROMs.

RESULTS

The ICC for repeated app-based 6WD measurements was 0.89 (95% CI 0.87–0.91, p < 0.001) and the SEM was 34 meters. The overall mean 6WD was 585.9 meters (95% CI 574.7–597.0 meters), with significant differences across age categories (p < 0.001). The 6WD was on average about 32 meters less in females (570.5 vs 602.2 meters, p = 0.005). There were linear correlations between average 6WD and VAS back pain, VAS leg pain, COMI Back and COMI subscores of pain intensity and disability, ZCQ symptom severity, ZCQ physical function, and ZCQ pain and neuroischemic symptoms subscores, as well as with subjective walking distance and duration, indicating that subjects with higher pain, higher disability, and lower subjective walking capacity had significantly lower 6WD (all p < 0.001).

CONCLUSIONS

This study provides normative data for app-based 6WD measurements in a multicenter sample from 8 institutions and 5 countries. These values can now be used as reference to compare 6WT results and quantify objective functional impairment in patients with degenerative diseases of the spine using z-scores. The authors found a good to excellent test-retest reliability of the 6WT app, a low area of uncertainty, and high content validity of the average 6WD with commonly used PROMs.