Time to listen: a review of methods to solicit patient reports of adverse events.

BACKGROUND: Patients have been shown to report accurate observations of medical errors and adverse events. Various methods of introducing patient reporting into patient safety systems have been published with little consensus among researchers on the most effective method. Terminology for use in patient safety reporting has yet to be standardised. METHODS: Two databases, PubMed and MEDLINE, were searched for literature on patient reporting of medical errors and adverse events. Comparisons were performed to identify the optimal method for eliciting patient initiated events. RESULTS: Seventeen journal publications were reviewed by patient population, type of healthcare setting, contact method, reporting method, duration, terminology and reported response rate. CONCLUSION: Few patient reporting studies have been published, and those identified in this review covered a wide range of methods in diverse settings. Definitive comparisons and conclusions are not possible. Patient reporting has been shown to be reliable. Higher incident rates were observed when open-ended questions were used and when respondents were asked about personal experiences in hospital and primary care. Future patient reporting systems will need a balance of closed-ended questions for cause analysis and classification, and open-ended narratives to allow for patient's limited understanding of terminology. Establishing the method of reporting that is most efficient in collecting reliable reports and standardising terminology for patient use should be the focus of future research.

Cerebrospinal fluid (CSF) leak and pseudomeningocele formation after posterior fossa tumor resection in children: a retrospective analysis.

OBJECTIVE: The purpose of this study was to determine the incidence of pseudomeningocele and cerebrospinal fluid (CSF) leak after posterior fossa tumor surgery and to analyze factors that may be associated with these conditions. In particular, we wished to determine if there was evidence to support the hypothesis that the use of tissue glue, dural grafts, or external ventricular drainage (EVD) prevented CSF from leaking outside the closed dura. MATERIALS AND METHODS: A retrospective chart review was carried out of posterior fossa tumor resections at British Columbia's Children's Hospital. Information was collected regarding tumor location, surgical approach, CSF diversion, dural grafting, and use of tissue glue. Multiple univariate analyses and step-wise logistic regression were performed to identify factors associated with pseudomeningocele formation or CSF leak. A pseudomeningocele was said to be present if it was noted in the clinical records or if a fluid collection was present superficial to the craniotomy flap on a postoperative CT or MR scan. RESULTS: Out of 174 posterior fossa operations, 53 pseudomeningoceles with or without CSF leak were identified along with five CSF leaks in the absence of pseudomeningocele (33%). None of the factors examined reached statistical significance, although there was a trend towards higher rates in patients with external CSF drainage (P=0.06631), dural graft usage (p=0.06492), and patients in whom tissue glue was used (p=0.06181). On logistic regression, only tissue glue use and external CSF drainage were associated with increased incidence of pseudomeningocele and/or CSF leak. CONCLUSION: In this retrospective study, the use of tissue glue, dural grafts, and external ventricular drainage was not associated with a reduced rate of clinically or radiologically diagnosed pseudomeningocele formation or postoperative CSF leak. The results of this study provide a basis for planning a randomized controlled trial to determine the effectiveness of tissue glue and/or dural grafting in preventing these complications.

The influence of surgical operative experience on the duration of first ventriculoperitoneal shunt function and infection.

The relationship of surgeon experience, measured by operative volume, to the outcomes of ventricular shunt treatment of hydrocephalus in children is not clear. This paper explores this relationship based on first ventriculoperitoneal shunts (VPS) implanted in English-speaking Canada during the period from April 1989 to March 2001. Three thousand seven hundred and ninety-four first VPS insertions, performed by 254 surgeons, were reviewed. Surgical experience was represented by the number of shunt operations performed during the study period by each surgeon prior to the date of the operation. The 6-month shunt failure risk for less experienced surgeons was 38%, compared to 31% for more experienced surgeons. This difference decreased to 4% at 60 months and 3% at 120 months (p = 0.001). The infection rate for initial shunt insertions was 7% for patients treated by more experienced surgeons and 9.4% for those treated by less experienced surgeons (p = 0.006). A relationship between surgeon experience and shunt outcome that appears to be based on the operative experience that a surgeon brings to a procedure is in keeping with clinical experience. This observation has implications for public policy, service planning and surgical mentorship during the earlier years of a surgeon's career.

Ventricular shunting for hydrocephalus in children: patients, procedures, surgeons and institutions in English Canada, 1989-2001.

INTRODUCTION AND PURPOSE: Ventricular shunting remains the principle and most generally applicable method to treat hydrocephalus in children. This paper describes the demographics of this treatment in English Canada during the period of 1989 to March 2001. METHODS: Hospital discharge records were obtained for patients less than 18 years who had a shunt inserted or revised. A database was constructed relating patients and procedures to hospital discharges based on scrambled patient identifiers, year of birth, sex, postal code and diagnoses. OBSERVATIONS: 5,947 patients underwent ventricular shunting procedures for hydrocephalus in this period. 261 surgeons working in 73 institutions provided 12,106 interventions (Shunt insertions: ventriculoperitoneal--5009, ventriculoatrial--119, ventriculopleural--28. Revisions: 6,950). Infection was deemed to have occurred in 1,059 procedures. Over the study period, the median number of procedures performed per surgeon per year was 2, with 75 % of surgeons performing 5 or fewer procedures in children per year. Although many surgeons operated on children throughout the thirteen years of the study, many did not acquire substantive cumulative experience. Overall infection rate was 8.6 %. Surgeon infection rates were greater than or equal to 20 % during the first four years of practice and thereafter they fell to and remained in the 10 % range. The mean shunt survival at 12 months of individual surgeons varied between 50 - 60 %, regardless of the number of years of experience of the surgeon; however, performance variability as measured by the standard deviation of 12 month survival rates for all surgeons, adjusted for years of experience, ranged widely until the fifth year of practice. The average number of procedures per year for treating hospitals was 2 with 75 %, providing 12 or fewer services annually. Over the entire study, 50 % of institutions provided 10 or fewer procedures. The mean institutional infection rate was 11.4 % (SD 23, median--6.0). CONCLUSIONS: Quality monitoring of infection rate and duration of shunt function remains critical as many surgeons and hospitals provide care to children with hydrocephalus infrequently. Variability in infection rates and shunt survival at 12 months are a function of surgeon experience, measured by years in practice. Variability in outcome decreases with increasing surgeon experience.

Clinical outcomes that fetal surgery for myelomeningocele needs to achieve.

INTRODUCTION: The development of techniques to close open neural tube malformations prior to birth has generated great interest and hope for fetal interventions and their outcomes. To plan a randomized trial, as is being discussed at three centres in the United States, the determination of what constitutes a clinically significant improvement in outcome is critical. To date, preliminary observations from two centres suggest that improvements may occur, not in spinal cord function as originally postulated, but in the extent of the hindbrain hernia and the frequency that shunting is required to control hydrocephalus. PURPOSE: The determination of what outcome would constitute an important and clinically significant difference in outcome to be achieved by fetal intervention for myelomeningocele. METHOD: Parents of patients and patients treated in our myelomeningocele clinic were surveyed using a structured and validated tool. From the perspective of a recommendation to a close friend or family member, the interviewees were asked to quantify on a scale from 0 to 100 the chance of specific outcomes (need for a shunt, need for a wheelchair, change of urinary incontinence) that a fetal operation would need to predictably achieve. RESULTS: Responses were obtained from 77 patients/families. The fifty percentile response in each study dimension was as follows: the chance of needing a shunt was 12 % (range 0 - 50 %), the chance of needing a wheelchair was 8 % and the chance of being incontinent was 5 % (range 0 - 25 %). CONCLUSIONS: Fetal interventions will have to achieve significant improvements in the control of hydrocephalus, mobilization and continence over postnatal treatment to be justified.

Cervical myelocystoceles and meningoceles: long-term follow-up.

Little is known about the long-term prognosis of patients with cervical myelocystoceles and meningoceles. In this study, we report the long-term follow-up (average 10 years and 8 months) of 8 patients with cervical myelocystoceles and meningoceles. Neurologic, orthopedic, urologic and psychosocial status was assessed on long-term follow-up. The results indicate that in patients with cervical myelocystoceles, neurologic deficits become noticeable in the first year of life as the infant matures. Motor deficit was common in these patients, whereas sensory and urologic deficits did not occur. We believe that this is related to underlying myelodysplasia. In addition, patients with cervical myelocystoceles tend to have significant orthopedic problems. In contrast, patients with cervical meningoceles do not have neurologic deficits, but do develop mild orthopedic problems.

Spontaneous resolution and recurrence of a Chiari I malformation and associated syringomyelia. Case report.

The spontaneous resolution of syringomyelia has been reported infrequently. In patients with Chiari I malformations, resolution of the syringomyelia has sometimes been associated with improvement of their malformation. The authors present a case of spontaneous resolution followed by recurrence of syringomyelia and a corresponding change in the Chiari malformation. This case is of interest in light of the theories postulated to explain spontaneous resolution of syringomyelia.

The patterns of late deterioration in patients with transitional lipomyelomeningocele.

INTRODUCTION: Tethering is assumed to be the primary cause of deterioration seen in children with transitional lipomyelomeningocele as they age. The inevitability of deterioration has led to recommendations for prophylactic interventions to stabilize or prevent further clinical deterioration. OBJECTIVE: Determine the frequency and patterns of functional deterioration observed after successful untethering in patients with transitional lipomyelomeningocele and compare functional outcomes with what is known regarding untreated patients. METHODS: Fifty patients having transitional LMMC, treated at a single institution and followed in a multidisciplinary clinic were retrospectively reviewed to determine their clinical status prior to untethering, and the time to development of new symptoms or signs following untethering. RESULTS: 82% of patients were diagnosed and 78% underwent untethering prior to one year of age. All patients had a cutaneous lumbosacral lipoma, 22 patients were considered normal at presentation and 28 showed abnormalities on clinical examination. Forty-nine patients were untethered successfully and all were available for follow-up ranging from 2 to 138 months (mean 39 months). Acute morbidity was limited to transient neurogenic bladder dysfunction and minor wound complications. Late clinical deterioration occurred in the majority of patients. Orthopedic and neurological deterioration occurred over the first 60 months following untethering and urological deterioration occurred thereafter. CONCLUSIONS: Functional loss after untethering is common and the pattern of loss is likely a reflection of the ability to detect abnormalities in this infant population. Untethering does not usually result in permanent acute morbidity, and does not prevent longer-term functional deterioration. The ratio of asymptomatic to symptomatic patients at follow-up in this operative series is similar to age-matched historical series of untreated patients.

Randomized trial of cerebrospinal fluid shunt valve design in pediatric hydrocephalus.

OBJECTIVE: Forty percent of standard cerebrospinal fluid shunts implanted for the treatment of pediatric hydrocephalus fail within the first year. Two new shunt valves designed to limit excess flow, particularly in upright positions, were studied to compare treatment failure rates with those for standard differential-pressure valves. METHODS: Three hundred-forty-four hydrocephalic children (age, birth to 18 yr) undergoing their first cerebrospinal fluid shunt insertion were randomized at 12 North American or European pediatric neurosurgical centers. Patients received one of three valves, i.e., a standard differential-pressure valve; a Delta valve (Medtronic PS Medical, Goleta, CA), which contains a siphon-control component designed to reduce siphoning in upright positions; or an Orbis-Sigma valve (Cordis, Miami, FL), with a variable-resistance, flow-limiting component. Patients were monitored for a minimum of 1 year. Endpoints were defined as shunt failure resulting from shunt obstruction, overdrainage, loculations of the cerebral ventricles, or infection. Outcome events were assessed by blinded independent case review. RESULTS: One hundred-fifty patients reached an endpoint; shunt obstruction occurred in 108 (31.4%), overdrainage in 12 (3.5%), loculated ventricles in 2 (0.6%), and infection in 28 (8.1%). Sixty-one percent were shunt failure-free at 1 year and 47% at 2 years, with a median shunt failure-free duration of 656 days. There was no difference in shunt failure-free duration among the three valves (P = 0.24). CONCLUSION: Cerebrospinal fluid shunt failure, predominantly from shunt obstruction and infection, remains a persistent problem in pediatric hydrocephalus. Two new valve designs did not significantly affect shunt failure rates.

Functional deterioration following placode untethering in myelomeningocele.

Placode untethering in myelomeningocele patients can result in improvement and/or stabilization of neurological function, spinal curvature and pain. This paper reviews the outcome of untethering procedures in 24 patients to determine the frequency of subsequent functional deterioration. Decreased range of movement, joint stiffness and changes in muscle tone were the commonest indications for surgical intervention, occurring in 15 patients. Untethering resulted in improvement in 8 patients, stabilization of progression in 6 and continued deterioration in 1 patient. Two patients previously untroubled with spasticity became symptomatic within 3 months of the procedure. Changes in ambulation were present preoperatively in 9 patients. Stabilization was observed in 4 and improvement in 5. One of the patients, who had improved, deteriorated during the 1st year of follow-up. Alterations in bladder capacity and continence occurred in 7 patients. Improvement was seen in 2 patients, deterioration in 2 and no change in 3. Of the patients who improved, 1 subsequently deteriorated again within the 2nd postoperative year. Of those patients who had stable bladder function preoperatively, 6 subsequently deteriorated despite untethering. Pain was a less frequent symptom, occurring in 6 patients. Six patients became pain-free within 3 months of untethering. Two patients who did not have pain preoperatively had pain at the operative site persisting for up to 3 months postoperatively. Of the 20 patients having a single untethering procedure to date, 11 have further symptoms that can be attributed to retethering.

Intrathecally administered baclofen for treatment of children with spasticity of cerebral origin.

Management of severe spasticity in children is often a difficult problem. Orally administered medications generally offer limited benefits. This study examines the value of intrathecally administered baclofen in the treatment of 19 children with severe spasticity of cerebral origin: eight of whom sustained brain injury associated with trauma, near drowning, or cardiac arrest; 10 with cerebral palsy (spastic quadriplegia); and one child with Leigh's disease. At the time of entry into the study, patients ranged from 4 to 19 years of age, and all were completely dependent on caretakers for activities of daily living. Children who responded positively to a trial dose of intrathecal baclofen underwent insertion of a drug delivery system for continuous infusion. This was followed by a double-blind trial of baclofen or placebo and follow-up review at 3 and 6 months, and yearly thereafter. Seven children did not undergo pump implantation because of excess sedation or poor response. The 12 remaining children have been followed for a period of 1 to 5 years. Favorable responses were present in all 12 children as determined by the Ashworth Scale, with the greatest benefit being reduction of lower limb tone. Except in the case of one child who had reduction in lower limb tone that resulted in difficulty with transfers, the caretakers all reported significant benefits from intrathecal baclofen, with improvement in muscle tone, behavior, sitting, and general ease of care being most commonly noted. Central side effects were seen in some children who received continuous intrathecal baclofen infusion and included hypotension (two patients), bradycardia (two), apnea or respiratory depression (two), and sedation (one). During a total of 568 months of pump operation there were 10 mechanical complications, including two related to pump or side port failure and eight related to catheter kinks, extrusions, or dislodgment. Pump pocket effusion occurred in five children and a cerebrospinal fluid fistula was seen in one child. Local infection occurred in three children and meningitis in two children. The results demonstrate the potential value of continuous intrathecal baclofen infusion for treatment of severe spasticity of cerebral origin. However, this treatment can result in significant complications and more experience is required before the long-term benefits can be determined.

A randomized clinical trial to compare selective posterior rhizotomy plus physiotherapy with physiotherapy alone in children with spastic diplegic cerebral palsy.

A randomized controlled single-blind trial was performed to compare lumbo-sacral selective posterior rhizotomy (SPR) followed by intensive physiotherapy, with intensive physiotherapy alone in improving motor function in children with spastic diplegic cerebral palsy. Fifteen patients were randomly assigned to each treatment modality. Patients in the SPR group had rhizotomy within 1 month, followed by intensive outpatient physiotherapy for 9 months. Patients assigned to physiotherapy alone had identical intensive physiotherapy. There was a statistically significant and clinically important difference in improvement in motor function in favor of the SPR group, with a mean increase in total Gross Motor Function Measure (GMFM) score of 11.3% at 9 months for the SPR group compared with 5.2% for the physiotherapy-only group (P = 0.007). Significant improvements in spasticity (P < 0.001) and range of movement (P < 0.001) were noted in the SPR group compared to the physiotherapy-only group. The results indicate that the improvement in motor function after SPR is more than can be explained by the associated intensive physiotherapy.

Value of postoperative surveillance imaging in the management of children with some common brain tumors.

The rationale for obtaining surveillance computerized tomography (CT) scans or magnetic resonance (MR) images in pediatric patients with brain tumors is that early detection of recurrence may result in timely treatment and better outcome. The purpose of this study was to investigate the value of surveillance cranial images in a variety of common pediatric brain tumors managed at a tertiary care pediatric hospital. A retrospective chart review was performed of children with astrocytoma of the cerebral hemisphere, cerebellum, optic chiasm/hypothalamus, or thalamus; cerebellar or supratentorial high-grade glioma; supratentorial ganglioglioma; posterior fossa or supratentorial primitive neuroectodermal tumor (PNET); and posterior fossa ependymoma. Data were analyzed to determine the frequency with which recurrences were identified on a surveillance image and how the type of image at which recurrence was identified related to outcome. In 159 children, 17 of 44 recurrences were diagnosed by surveillance imaging. The percentage of recurrences identified by surveillance imaging was 64% for ependymoma, 50% for supratentorial PNET, 43% for optic/hypothalamic astrocytoma, and less than 30% for other tumors. The rate of diagnosis of recurrence per surveillance image varied from 0% to 11.8% for different tumor types. Only for ependymomas did there appear to be an improved outcome when recurrence was identified prior to symptoms. Our results indicate that, using the protocols outlined in this study, surveillance imaging was not valuable in identifying recurrence of cerebellar astrocytoma or supratentorial ganglioglioma during the study period, but was probably worthwhile in identifying recurrence of posterior fossa ependymoma and optic/hypothalamic astrocytoma and, possibly, medulloblastoma. Surveillance protocols could be made more effective by individualizing them for each type of tumor, based on current data on the patterns of recurrence.

Prenatal spinal evaluation and functional outcome of patients born with myelomeningocele: information for improved prenatal counselling and outcome prediction.

OBJECTIVE: Prenatal ultrasonography can localize the level of the spinal cord malformation, allowing prediction of the potential postnatal neurological deficit and functional prognosis. METHODS: This study has two evaluations: (a) a retrospective prenatal review of 26 fetuses with spinal dysraphism (1987-1991), and (b) a follow-up descriptive study of patients (1971-1981) who underwent closure of the spinal lesion and ventricular shunting in the neonatal period. RESULTS: Prenatal ultrasound evaluation enabled the accurate definition of the last intact vertebral level which allows separation of fetuses into three functional groups (last intact level L2, L3-4, L5-sacral). Patterns of ambulation, urinary and bowel continence, and school performance vary according to level of spinal lesion and the neurological deficit. The need for ventricular shunts, the incidence of other spinal malformations and surgical interventions did not vary with the level of the spinal lesion. CONCLUSIONS: The functional outcome for patients with myelomeningocele is variable; however, distinct patterns emerge based on the level of spinal dysraphism and the resultant neurological deficit. By relating the level of the fetal spinal lesion to outcome data, more precise functional prognoses can be given to families.