Digitizing Data Management for Intraoperative Neuromonitoring.

Intraoperative neurophysiological monitoring (IOM) enables a function-preserving surgical strategy for surgeries of brain or spinal cord pathologies by neurophysiological measurements. However, the IOM data management at neurosurgical institutions are often either not digitized or inefficient in terms of collecting, storing and processing of IOM data. Here, we describe the development of a web application, called IOM-Manager, as a first step towards the complete digitization of the IOM workflow. The web application is used for structured protocoling based on standardized protocol entry catalog, data archiving, and data analysis. These functionalities are based on the results of the requirement engineering of a process analysis, a survey with potential users and a market analysis. A usability test with one IOM team indicated the IOM-Manager and its other components can in fact solve many problems of existing solutions.

A Protocol Entry Catalog for Intraoperative Neuromonitoring - Steps Towards an Ontology.

In neurosurgery, intraoperative neurophysiological monitoring (IOM) with continuous measurements of neural electrical activity may reduce the risk of postoperative deficits. During an IOM, surgical information as well as neurophysiological, surgical and anesthesia events have to be recorded. So far, there is no common standard for this task available. In this paper, such a standardization with the aim of facilitating the data input and making the protocols data available for different sorts of analyses is described. We developed a protocol entry catalog with 200 standard expressions, which were divided into four categories: IOM, surgical procedure, anesthesia and others. An empirical assessment of the catalog by the IOM team showed the need for subcategories. In the final version of the catalog, the standard terms were grouped into 25 subcategories. The catalog is a first step to support systematic research into the occurrence of clinical events during the IOM and their association with postoperative neurological deficits that could enable improved surgical procedures in the future.

Postoperative navigated transcranial magnetic stimulation to predict motor recovery after surgery of tumors in motor eloquent areas.

OBJECTIVE: To know whether motor deficits after tumor surgery are transient is reassuring for the patient and crucial for planning rehabilitation and adjuvant treatment. We analyze the value of postoperative MRI navigated transcranial magnetic stimulation (nTMS) compared to intraoperative MEP monitoring in predicting recovery of motor function. METHODS: Retrospective series of nTMS mappings within 14 days after surgery for supratentorial tumors (09/2014-05/2018). All patients with motor deficits of Medical-Research-Council-Grade (MRCS) 0-4- were included. RESULTS: We performed nTMS mapping on average 3.8 days after surgery and recorded nTMS MEP in 11 of 13 patients. Motor strength recovered to at least MRCS 4 within one month if postoperative nTMS elicited MEPs (positive predictive value 90.9%). If nTMS did not elicit MEPs, the patient did not recover (negative predictive value 100%). Intraoperative MEP and postoperative nTMS were equally predictive for long-term motor recovery. In cases of intraoperative MEP alteration/signal loss, but a positive postoperative nTMS mapping, 2/3 patients demonstrated a good motor recovery. CONCLUSION: nTMS may predict long-term motor recovery of patients suffering from severe motor deficits directly after resection of tumors located in motor eloquent areas. SIGNIFICANCE: In cases of intraoperative MEP alterations, postoperative nTMS may clarify the potential for motor recovery.

A Concept for a Data Dictionary System Supporting for Clinical Research.

Clinical trials form the backbone of evidence-based medicine. They are indispensable tools that make it possible to compare medical interventions or test medical devices for their efficacy and safety. Each study design exactly defines which data is to be collected. Case report forms (CRFs) are used to document the collected data. Preparing CRFs is complicating, time consuming and requires extensive knowledge in the fields of medicine, data management and statistics. In addition, there are no global standards for CRF design, which means that each research institution produces CRF data definitions at its own discretion. This hampers the exchange of data definitions among different research groups and variants of CRFs might be created for a similar study design. To address these problems, we developed a concept for a freely accessible portal in the form of a web application in which definitions for CRFs, variables and tables can be created. The created data definitions can be exported from the portal to be transferred to common electronic data capture systems (EDC) that can then generate CRFs using the definition. The overall objective of the project is to develop a data dictionary system that is used during the entire workflow of a study and that enables sharing and re-use of metadata.

Predictors of speech outcomes in children with Pierre Robin sequence.

BACKGOUND: Pierre Robin sequence (PRS) has worse speech outcomes than isolated cleft palate. We aimed to search for possible associations of phonological outcomes with PRS status (isolated vs syndromic), clinical severity, soft palate muscles deficiency, or surgical procedure. METHODS: We designed a retrospective study of 130 children (male/female ratio: 0.4) with isolated (96) or syndromic (34) PRS with cleft palate. Grading systems were used to classify retrognathia, glossoptosis, and respiratory and feeding disorders. Electromyography was used to investigate levator veli palatini muscles. Hard cleft palate was measured using maxillary casts. Intravelar veloplasty was performed using the Sommerlad's technique. Phonological outcomes were assessed using the Borel-Maisonny classification. RESULTS: Cleft palate was repaired in one stage (65.5%) or hard palate closure was postponed (34.5%). Velopharyngeal insufficiency was more frequent in syndromic PRS (53%) vs. isolated PRS (30.5%) (p = 0.01), but was not statistically associated with clinical grade, hard cleft palate width, soft palate electromyography, and surgical procedure. CONCLUSIONS: In children with PRS, anatomic variables, initial clinical severity, and soft palate muscle deficiency are not predictors of speech prognosis.

Grommets and speech at three and six years in children born with total cleft or cleft palate.

OBJECTIVE: Grommets may be considered as the treatment of choice for otitis media with effusion (OME) in children born with a cleft. But the timing and precise indications to use them are not well established. The aim of the study is to compare the results of hearing and speech controls at three and six year-old in children born with total cleft or cleft palate in the presence or not of grommets. METHODS: This retrospective study concerns non syndromic children born between 1994 and 2006 and operated for a unilateral cleft lip palate (UCLP) or a cleft palate (CP) alone, by one surgeon with the same schedule of operations (Malek procedure). We compared the results of clinical observation, tympanometry, audiometry and nasometry at three and six year-old. The Borel-Maisonny classification was used to evaluate the velar insufficiency. None of the children had preventive grommets. The Fisher Exact Test was used for statistical analysis with p<0.05 considered as significant. RESULTS: Seventy-seven patients were analyzed in both groups. Abnormal hearing status was statistically more frequent in children with UCLP compared to children with CP, at three and six years (respectively, 80-64%, p<0.03 and 78-60%, p<0.02), with the use of grommets at six years in 43% of cases in both groups. Improvement of hearing status between three and six year-old was present in 5% of children with UCLP and 9% with CP, without the use of grommets. CONCLUSION: The use of grommets between three and six year-old was not associated to any improvement of hearing status or speech results children with UCLP or with CP, with a low risk of tympanosclerosis. These results favor the use of grommets before the age of three, taking into account the risk of long term tympanosclerosis.

Rhinopharyngeal autologous fat injection for treatment of velopharyngeal insufficiency in patients with cleft palate.

Patients with cleft palate are prone to velopharyngeal insufficiency. In minor cases or when hypernasal speech does not resolve after velopharyngoplasty, an augmentation pharyngoplasty with autologous fat can be proposed. The aim of the present study is to evaluate the short-term (within 2 months) and long-term efficiency (during the 24 months following the procedure) of our procedure in the setting of velopharyngeal insufficiency related to a cleft palate. Twenty-two patients with cleft palate related velopharyngeal insufficiency were included in this retrospective study. All patients were operated following the same technique, in the same institution. The pre- and postoperative evaluations included a nasometry, a subjective evaluation using the Borel-Maisonny score, and a nasofibroscopy to assess the degree of velopharyngeal closure. Scores of Borel-Maisonny and nasometry were compared before, shortly after the procedure (within 2 months) and long term after the procedure (within 24 months). Forty-one procedures in 22 patients with a cleft palate performed in our institution between October 2004 and January 2012 were included in the study. Nine patients had a previous velopharyngoplasty with persistent rhinolalia despite intensive speech therapy. In 14 patients the procedure was repeated because of recurrent hypernasal speech after the first injection. The average number of procedures per patient was 1.8. Postoperative nasometry and Borel-Maisonny scores were statistically significantly improved and remained stable until the end of the follow-up (median 42 months postoperative) in most patients. Complications were rare and minor. Autologous fat injection is a simple procedure for treatment of minor velopharyngeal insufficiencies in patients with cleft palate, with good long-term results and few complications.

Speech prognosis and need of pharyngeal flap for non syndromic vs syndromic Pierre Robin Sequence.

BACKGROUND: The aim of this retrospective study was to evaluate speech outcome and need of a pharyngeal flap in children born with nonsyndromic Pierre Robin Sequence (nsPRS) vs syndromic Pierre Robin Sequence (sPRS). METHODS: Pierre Robin Sequence was diagnosed when the triad microretrognathia, glossoptosis, and cleft palate were present. Children were classified at birth in 3 categories depending on respiratory and feeding problems. The Borel-Maisonny classification was used to score the velopharyngeal insufficiency. RESULTS: The study was based on 38 children followed from 1985 to 2006. For the 25 nsPRS, 9 (36%) pharyngeal flaps were performed with improvements of the phonatory score in the 3 categories. For the 13 sPRS, 3 (23%) pharyngeal flaps were performed with an improvement of the phonatory scores in the 3 children. There was no statistical difference between the nsPRS and sPRS groups (P = .3) even if we compared the children in the 3 categories (P = .2). CONCLUSIONS: Children born with nsPRS did not have a better prognosis of speech outcome than children born with sPRS. Respiratory and feeding problems at birth did not seem to be correlated with speech outcome. This is important when informing parents on the prognosis of long-term therapy.

Speech outcome after cranial-based pharyngeal flap in children born with total cleft, cleft palate, or primary velopharyngeal insufficiency.

PURPOSE: The aim of this study was to compare the effect of a cranial-based pharyngeal flap on the speech of children born with a unilateral cleft lip and palate (UCLP), bilateral cleft lip and palate (BCLP), cleft palate (CP), or primary velopharyngeal insufficiency (VPI) without cleft. PATIENTS AND METHODS: A total of 234 children born with clefts and 22 children born with primary VPI were evaluated. Children with associated abnormalities were excluded from this study. The Borel-Maisonny classification system was used to evaluate the velar insufficiency. The cranial-based pharyngeal flap was performed using the Sanvenero-Rosselli technique. RESULTS: Between 1984 and 2001, 74 children underwent pharyngeal flap for VPI. The mean follow-up period was 7 years. Borel-Maisonny scores after pharyngeal flap surgery were as follows: children with UCLP (n = 22), 59.1% type 1, 36.4% type 1/2, and 4.5% type 2; children with BCLP (n = 18), 44.4% type 1, 27.8% type 1/2, 16.7% type 2, and 11.1% type 2/3; children with CP (n = 17), 64.7% type 1, 23.5% type 1/2, and 11.8% type 2; children with primary VPI (n = 17), 29.4% type 1, 29.4% type 1/2, 29.4% type 2/3, and 11.8% type 3. There were significant differences in outcome among the 4 groups (P = .029; Fisher exact test). CONCLUSIONS: The positive effect on speech of a cranial-based pharyngeal flap is greater in children born with a UCLP or CP than in those born with a BCLP. In children born with primary VPI, this operation has only a slightly positive effect on speech that shows compensatory misarticulations; in such cases, alternative surgical choices or secondary procedures may be indicated. This information should be clearly conveyed to the parents in presurgical consultation so that they know what to expect from the procedure and postoperative adjuvant therapy.