Implementing structured team debriefing using a Black Box in the operating room: surveying team satisfaction.

BACKGROUND: Surgical safety may be improved using a medical data recorder (MDR) for the purpose of postoperative team debriefing. It provides the team in the operating room (OR) with the opportunity to look back upon their joint performance objectively to discuss and learn from suboptimal situations or possible adverse events. The aim of this study was to investigate the satisfaction of the OR team using an MDR, the OR Black Box®, in the OR as a tool providing output for structured team debriefing. METHODS: In this longitudinal survey study, 35 gastro-intestinal laparoscopic operations were recorded using the OR Black Box® and the output was subsequently debriefed with the operating team. Prior to study, a privacy impact assessment was conducted to ensure alignment with applicable legal and regulatory requirements. A structured debrief model and an OR Back Box® performance report was developed. A standardized survey was used to measure participant's satisfaction with the team debriefing, the debrief model used and the performance report. Factor analysis was performed to assess the questionnaire's quality and identified contributing satisfaction factors. Multivariable analysis was performed to identify variables associated with participants' opinions. RESULTS: In total, 81 team members of various disciplines in the OR participated, comprising 35 laparoscopic procedures. Mean satisfaction with the OR Black Box® performance report and team debriefing was high for all 3 identified independent satisfaction factors. Of all participants, 98% recommend using the OR Black Box® and the outcome report in team debriefing. CONCLUSION: The use of an MDR in the OR for the purpose of team debriefing is considered to be both beneficial and important. Team debriefing using the OR Black Box® outcome report is highly recommended by 98% of team members participating.

Legal perspectives on black box recording devices in the operating environment.

BACKGROUND: A video and medical data recorder in the operating theatre is possible, but concerns over privacy, data use and litigation have limited widespread implementation. The literature on legal considerations and challenges to overcome, and guidelines related to use of data recording in the surgical environment, are presented in this narrative review. METHODS: A review of PubMed and Embase databases and Cochrane Library was undertaken. International jurisprudence on the topic was searched. Practice recommendations and legal perspectives were acquired based on experience with implementation and use of a video and medical data recorder in the operating theatre. RESULTS: After removing duplicates, 116 citations were retrieved and abstracts screened; 31 articles were assessed for eligibility and 20 papers were finally included. According to the European General Data Protection Regulation and US Health Insurance Portability and Accountability Act, researchers are required to make sure that personal data collected from patients and healthcare professionals are used fairly and lawfully, for limited and specifically stated purposes, in an adequate and relevant manner, kept safe and secure, and stored for no longer than is absolutely necessary. Data collected for the sole purpose of healthcare quality improvement are not required to be added to the patient's medical record. CONCLUSION: Transparency on the use and purpose of recorded data should be ensured to both staff and patients. The recorded video data do not need to be used as evidence in court if patient medical records are well maintained. Clear legislation on data responsibility is needed to use the medical recorder optimally for quality improvement initiatives.

ANTECEDENTES: Es posible instalar un sistema de video y grabación de datos médicos en el quirófano, pero su implementación se ha visto limitada por las dudas relativas a la privacidad, uso de datos y aspectos de litigio. Estas dudas deberían superarse, motivo por el que en este trabajo se proponen unas guías sobre el uso de sistemas de registro en el ambiente quirúrgico. MÉTODOS: Se realizó una revisión en las bases de datos Pubmed y Embase y de la Biblioteca Cochrane. Se buscó la jurisprudencia internacional sobre el tema. Se establecieron unas recomendaciones prácticas y de las perspectivas legales adquiridas a través de la experiencia de la implementación y el uso de sistemas de video y registro de datos médicos en el quirófano. RESULTADOS: Se obtuvieron 116 referencias, de las que una vez eliminadas las duplicadas (n = 5) y revisados los resumenes, 31 artículos cumplían los criterios de eligibilidad. En el estudio final se incluyeron 20 artículos. De acuerdo con la Ley Orgánica de Protección de Datos (General Data Protection Regulation, GDRP) y la Ley de Transferencia y Responsabilidad de Seguro Médico (Health Insurance Portability and Accountability Act, HIPAA), los investigadores deben asegurar que los datos personales recopilados pertenecientes a los pacientes y profesionales de la salud se utilicen de manera justa y legal, con fines definidos y bien establecidos, de manera adecuada y relevante, y mantenidos a resguardo y almacenados no más tiempo del estrictamente necesario. No es necesario que los datos recopilados con el único propósito de mejorar la calidad de la atención médica se agreguen a la historia clínica del paciente. CONCLUSIÓN: Se debe asegurar por parte del personal sanitario como del paciente, la transparencia tanto en la utilización como en el objetivo de los datos almacenados. Los datos registrados en video no es necesario que sean usados como evidencia en procesos judiciales si la historia clínica de los pacientes cumple los estandares establecidos. Se precisa una legislación clara sobre la responsabilidad de los datos para la utilización óptima de los registros médicos en las iniciativas de mejora de la calidad.

[Long-term goals for oral health]. / Lang leve de duurzame mondzorg.

The current, optimistic prognosis is that newborns will reach an average age of 100 years. This increased life-expectancy requires a renewed vision of long-term goals for oral health. The starting-point could be a prospective end-point with minimal oral function which should be reached, for example, in the last years of one's life. The consequence is that adequate oral healthcare for the elderly starts in childhood. Choices such as the extraction of premolars for orthodontic reasons and the dental re-restoration cycle have a great negative impact on reaching this goal. The average sustainability of dental restorations or prosthetic constructions is commonly much shorter than the life-expectancy of a patient. If oral treatment is necessary, it is recommended to give priority to maintaining a minimally functional dentition up to an advanced age, instead offocusing on short- or medium-term goals.

Pelvic floor dysfunction is not a risk factor for febrile urinary tract infection in adults.

OBJECTIVE: To determine whether pelvic floor dysfunction (PFD) might be a risk factor for or consequence of febrile urinary tract infection (UTI), as UTI in adults is a common infection in which an underlying urological abnormality is often considered, and as in children, PFD is also thought to have a pathophysiological role in adults with UTI. PATIENTS AND METHODS: A multicentre case-control study was conducted at 26 primary-care centres and at six Emergency Departments of regional hospitals. Cases were consecutive patients aged > or =18 years, who presented with febrile UTI. Controls were randomly selected subjects who visited their general practitioner for reasons other than UTI or fever. A validated pelvic floor questionnaire (the Pelvic Floor Inventories Leiden, PelFIs) was used to assess pelvic floor function. RESULTS: Between October 2006 and December 2007, 153 cases were included; of these, the completed questionnaires of 102 (response rate 67%) were compared to those of 100 of 110 (response rate 91%) controls. The median age of cases and controls was 65 and 58 years, respectively; 40% of cases and controls were men. The percentage of PelFIs outcomes consistent with PFD were comparable between cases and controls, at 21% vs 23%, respectively (odds ratio 0.9, 95% confidence interval, CI, 0.4-1.78). In the multivariate analysis, comorbidity (odds ratio 4.9, 95% CI 2.2-11.1) and a history of UTI (odds ratio 2.5, 95% CI 1.0-6.1) were independent significant risk factors for febrile UTI, whereas PFD was not (odds ratio 1.0, 0.5-2.2). Within the group of cases, PFD was not associated with bacteriuria during assessment of PelFIs (odds ratio 1.1, 95% CI 0.4-3.5) and inversely related to a history of UTI within the previous year (odds ratio 0.2, 0.1-0.9). CONCLUSIONS: PFD is common among adults but it does not seem to be a risk factor for febrile UTI.

Significance of serum CA125 and TPS antigen levels for determination of overall survival after three chemotherapy courses in ovarian cancer patients during long-term follow-up.

PURPOSE OF INVESTIGATION: To evaluate the prognostic significance for overall survival rate for the marker combination TPS and CA125 in ovarian cancer patients after three chemotherapy courses during long-term clinical follow-up. METHODS: The overall survival of 212 (out of 213) ovarian cancer patients (FIGO Stages I-IV) was analyzed in a prospective multicenter study during a 10-year clinical follow-up by univariate and multivariate analysis. RESULTS: In patients with ovarian cancer FIGO Stage I (34 patients) or FIGO Stage II (30 patients) disease, the univariate and multivariate analysis of the 10-year overall survival data showed that CA125 and TPS serum levels were not independent prognostic factors. In the FIGO Stage III group (112 patients), the 10-year overall survival was 15.2%; while in the FIGO Stage IV group (36 patients) a 10-year overall survival of 5.6% was seen. Here, the tumor markers CA125 and TPS levels were significant prognostic factors in both univariate and multivariate analysis (p < 0.0001). In a combined FIGO Stage III + FIGO Stage IV group (60 patients with optimal debulking surgery), multivariate analysis demonstrated that CA125 and TPS levels were independent prognostic factors. For patients in this combined FIGO Stage III + IV group having both markers below respective discrimination level, 35.3% survived for more than ten years, as opposed to patients having one marker above the discrimination level where the 10-year survival was reduced to 10% of the patients. For patients showing both markers above the respective discrimination level, none of the patients survived for the 10-year follow-up time. CONCLUSION: In FIGO III and IV ovarian cancer patients, only patients with CA 125 and TPS markers below the discrimination level after three chemotherapy courses indicated a favorable prognosis. Patients with an elevated level of CA 125 or TPS or both markers after three chemotherapy courses showed unfavorable prognosis.

Tumour markers in colorectal cancer: European Group on Tumour Markers (EGTM) guidelines for clinical use.

The aim of this article is to present updated guidelines for the use of serum, tissue and faecal markers in colorectal cancer (CRC). Lack of specificity and sensitivity preclude the use of all existing serum markers for the early detection of CRC. For patients with stage II or stage III CRC who may be candidates for either liver resection or systemic treatment should recurrence develop, CEA should be measured every 2-3 months for at least 3 years after diagnosis. Insufficient evidence exists to recommend routine use of tissue factors such as thymidylate synthase, microsatellite instability (MSI), p53, K-ras and deleted in colon cancer (DCC) for either determining prognosis or predicting response to therapy in patients with CRC. Microsatellite instability, however, may be used as a pre-screen for patients with suspected hereditary non-polyposis colorectal cancer. Faecal occult blood testing but not faecal DNA markers may be used to screen asymptomatic subjects 50 years or older for early CRC.

Coexpression of c-erbB 1-4 receptor proteins in human glioblastomas. An immunohistochemical study.

Studies support involvement of the erbB/HER (human epidermal growth factor receptor) family, comprising the c-erbB-1/2/3/4 receptor proteins, in the tumourigenesis of human gliomas, raising their potential role in diagnostic and therapeutic approaches to these tumours. Reliable detection systems for these molecules in glioma tissue are therefore needed. Formalin-fixed and paraffin-embedded sections from twenty-one human glioblastomas were investigated by standard immunohistochemical procedures for expression of c-erbB-1/2/3/4 receptor proteins using commercial antibodies. All the antibodies used worked satisfactorily on paraffin-sections. For EGFR (epidermal growth factor receptor) two antibodies reactive against the external and internal domain were used. The first revealed positive immunoreactivity in 13 of 21 tumours (62 %), whereas all were positive with the latter. All glioblastomas were negative for the mutated variant of EGFR (i.e. EGFRvIII). Nine of 21 tumours (43 %) were immunoreactive for c-erbB-2, 19 of 20 tumours (95 %) for c-erbB-3, and 21 of 21 for c-erbB-4. Kaplan-Meier plots as a function of growth factor receptor expression did not show any significant association with survival among the glioblastoma patients. In conclusion, immunohistochemistry is well suited for detection of erb receptor proteins in glioblastoma tissue and demonstrated abundant and simultaneous immunoreactivity of these receptors.

Immunohistochemical detection of epidermal growth factor receptor in human high-grade astrocytomas--a comparison between frozen- and paraffin sections.

The overexpression of epidermal growth factor receptor (EGFR) in human astrocytic tumours is associated with the oncogenesis of these tumours. Ongoing research on diagnostic, prognostic, and therapeutic aspects of this receptor is highly dependent on the development of reliable techniques for the detection of EGFR in tumour tissue. The aim of this study was to assess EGFR expression in human high-grade astrocytomas by means of immunohistochemistry on formalin-fixed, paraffin-embedded sections and to compare these findings with the results of our previous study on frozen sections from these tumours, in which we found about 60% EGFR positivity (10). Four anaplastic astrocytomas and 19 glioblastomas were included in this study. Two different antibodies were used, the monoclonal antibody E30 reactive against the extracellular domain of EGFR and the polyclonal antibody Ab-4 directed against its cytoplasmic domain. With E30, 3 out of 4 anaplastic astrocytomas (75%) and 12 out of 19 glioblastomas (63%) were found to express EGFR whereas Ab-4 demonstrated positive EGFR immunoreactivity in most of the tumours (18/19 glioblastomas and all the 4 anaplastic astrocytomas). In conclusion, immunohistochemistry represents a reliable and convenient technique for the detection of EGFR in tissue sections of human high-grade astrocytomas, and that EGFR immunoreactivity is comparable in frozen- and paraffin sections from these tumours.

C-erbB-2/HER-2 protein in human intracranial tumours.

Normal and neoplastic human intracranial tissues were examined by immunohistochemistry for c-erbB-2/HER-2 protein expression. Positive staining was observed in 1/41 gliomas, 1/2 medulloblastomas, 1/1 germinoma, 11/16 meningiomas, 1/3 anaplastic meningiomas and 11/19 metastatic brain carcinomas. No positive staining was observed in normal intracranial tissues. Thus, the expression of the c-erbB-2/HER-2 protein is limited to intracranial tumour tissues, principally meningiomas and metastatic carcinomas to the brain.

Clinical utility of biochemical markers in colorectal cancer: European Group on Tumour Markers (EGTM) guidelines.

In recent years, numerous serum and cell/tissue-based markers have been described for colorectal cancer (CRC). The aim of this article was to provide guidelines for the routine clinical use of some of these markers. Lack of sensitivity and specificity preclude the use of any available serum markers such as carcinoembryonic antigen (CEA), CA 19-9, CA 242, CA 72-4, tissue polypeptide antigen (TPA) or tissue polypeptide-specific antigen (TPS) for the early detection of CRC. However, preoperative measurement of CEA is desirable as this may give independent prognostic information, help with surgical management and provide a baseline level for subsequent determinations. For patients with stage 2 (Dukes' B) and 3 (Dukes' C) disease who may be candidates for liver resection, CEA levels should be measured every 2-3 months for at least 3 years after diagnosis. For monitoring treatment of advanced disease, CEA should also be tested every 2-3 months. Insufficient evidence is presently available to recommend the routine use of other serum markers for monitoring purposes. Similarly, the new cell and tissue-based markers (e.g, ras, P53) cannot yet be recommended for routine clinical use.

Lateralisation and depth of the internal mammary chain determined by scintigraphy and by ultrasonography: a comparative study in 124 primary breast cancer patients.

In 124 primary breast cancer patients the maximum values of the lateralisation of the internal mammary chain (IMC) and their corresponding depths could be determined by scintigraphy and ultrasonography in 77% and 85% of the cases, respectively. With respect to the lateralisation it appeared that these values were uncorrelated between the two methods. With respect to depth correlation was found (correlation coefficient 0.34; P=0.001). We conclude that substantial differences are noted. Irradiation of the IMC based on computed tomography treatment planning might be a better alternative.

Epidermal growth-factor and transforming growth factor-alpha in human meningiomas.

Recently we have shown that human meningiomas overexpress epidermal growth factor receptor (EGFR) (Torp SH et al APMIS 100: 797-802, 1992). We therefore wanted to examine these tumours for the expression of the EGFR ligands epidermal growth factor (EGF) and transforming growth factor-alpha (TGF-alpha). Normal human meningeal tissues were used as controls. Immunohistochemistry (IH) and radioimmunoassay (RIA) demonstrated the presence of EGF and/or TGF-alpha. immunoreactivity in sixteen of nineteen meningiomas. By means of RIA detectable amount of TGF-alpha was also recorded in normal leptomeninges. Discrepancies between IH and RIA were noted and are discussed. Our findings suggest that EGFR/EGF/TGF-alpha play a role in growth regulatory mechanisms in human meningiomas.

Effects of interferon-gamma and tumor necrosis factor-alpha on clonogenic growth of cell lines and primary cultures from human gliomas and brain metastases.

In this study we tested the effect of interferon-gamma (IFN-gamma), tumor necrosis factor-alpha (TNF-alpha) and a combination of these immunotherapeutics on clonogenic growth of cell lines and primary cultures of malignant human brain tumors. Out of 29 primary cultures studied, 5 were inhibited 50% or more by IFN-gamma (10 ng/ml), 6 were inhibited 50% or more by TNF-alpha (10 ng/ml) and 14 were inhibited 50% or more by a combination of IFN-gamma (10 ng/ml) and TNF-alpha (10 ng/ml). The doses of the immunotherapeutics used in this in vitro study are achievable in serum after intravenous administration of IFN-gamma and TNF-alpha without causing unacceptable side effects. We believe that some glioma patients and some patients with brain metastases will benefit from receiving treatment with IFN-gamma, TNF-alpha or a combination of these immunotherapeutics. The patients should be selected for treatment with these immunotherapeutics according to in vitro sensitivity results.

Expression of epidermal growth factor receptor in human meningiomas and meningeal tissue.

The aim of this study was to examine meningeal tissue under normal, reactive, and neoplastic conditions for expression of epidermal growth factor receptor (EGFR) using an improved histochemical method, namely biotinylated epidermal growth factor. EGFR was found in all the examined meningiomas (12 benign and three anaplastic) and in neonatal rat meninges, whereas normal and injured adult human and rat meninges did not exhibit detectable EGFR. These observations indicate that EGFR is involved in the development of meningeal tissue. Further, EGFR is abnormally expressed in meningeal tumours, indicating a role of EGFR in the neoplastic process of these tumours. The regular expression of EGFR in human meningiomas suggests EGFR as a tumour marker for this tumour type.

Transforming growth factor-beta 1 is a potent inducer of plasminogen activator inhibitor type-1 in human glioblastoma and carcinoma cell lines.

Transforming growth factor-beta 1 has been shown to suppress the urokinase activity in the glioblastoma cell line T-MG1 and the carcinoma cell line T-CAR1. The molecular mechanisms behind the decrease in the proteolyic activity is shown to be at least partly due to increased synthesis of plasminogen activator inhibitor type-1 and not by decreased synthesis of urokinase.

Expression of the epidermal growth factor receptor gene in human brain metastases.

Biopsy specimens of human brain metastases were examined for amplification and expression of the proto-oncogene c-erbB1 (located on chromosome 7) encoding the epidermal growth factor receptor (EGFR). Moreover, the tumour DNA was also examined for amplification of other cancer-related genes on this chromosome: the proto-oncogene c-met, the gene for platelet-derived growth factor A-chain, and the gene for plasminogen activator inhibitory type 1. All 18 brain metastases demonstrated positive binding of biotinylated EGF on cryosections. Three out of 18 metastases had amplification of the EGFR gene; the other chromosome-7 genes tested were not amplified. Thus, an increased EGFR gene expression seems to be a general finding in a wide range of carcinomas metastatic to the brain, whereas we found only occasional selective EGFR gene amplifications in single cases.

Polysomy of chromosome 7 is associated with amplification and overexpression of the EGF-receptor gene in a human carcinoma cell line derived from a brain metastasis.

Overexpression of the EGF-receptor gene is associated with the malignant nature of some tumors. We have recently reported the establishment of a human carcinoma cell line (T-CAR1), derived from a brain metastasis, that had 7 million EGF receptors per cell and was growth inhibited by EGF. The present study was carried out in order to further characterize the EGF-receptor protein in T-CAR1 cells, and to see if the overexpression of the EGF-receptor gene in these cells was associated with abnormalities at the genomic level. We have compared the T-CAR1 cells with the human glioblastoma cell line T-MG1, which has 135,000 EGF-receptors and is growth stimulated by EGF. The MW of the EGF receptors in T-CAR1 cells and T-MG1 cells was estimated to be 170 kDa, equal to the normal EGF-receptor. However, in T-CAR1 cells an additional protein reacted with the monoclonal antibody directed against the internal domain of the EGF receptor. The levels of EGF receptor-related RNAs in T-CAR1 cells and T-MG1 cells reflected the number of EGF receptors in these cell lines. The EGF-receptor gene was amplified ten-fold in T-CAR1 cells, while it was not amplified in T-MG1 cells. No restriction fragment length polymorphism of DNA digested with various restriction enzymes was seen in either of the cell lines. Chromosomal analysis of T-CAR1 cells showed polysomy of chromosome 7 and marker chromosomes derived partly from chromosome 7. Thus, in the T-CAR1 cell line it was an association between polysomy of chromosome 7 and EGF-receptor gene amplification.

Genital Chlamydia trachomatis infections in patients with abnormal cervical smears: effect of tetracycline treatment on cell changes.

A group of 1760 women aged 14-35 years were examined for the concurrent presence of Chlamydia trachomatis and cellular atypia of cervical smears. Positive tests for C trachomatis were found in 126 women (7.2%). Cell changes were found in 85 women (4.8%), and 25 of these were C trachomatis-positive. Slight cellular atypia was the major finding in the smears from 22 of the C trachomatis-positive women, whereas three patients had more pronounced cell changes. Smears reverted to normal in 18 of the 23 patients who returned for tetracycline treatment and follow-up cytology. All 18 patients had smears showing slight cellular atypia prior to therapy. In five patients who also had cellular changes suggesting a human papillomavirus infection, the smears did not revert to normal after antibiotic therapy during the observation period. These findings suggest that patients with C trachomatis and mild cellular atypia should have antibiotic therapy and repeat smears taken before further treatment is considered. More advanced cellular atypia is unlikely to be caused by C trachomatis.

The acute effects of norharman on cocaine self-administration and sensorimotor function in male Wistar rats.

The purpose of the present study was to determine the acute effects of the beta-carboline norharman on cocaine dependence. Male Wistar rats were allowed to self-administer cocaine for 3 h for seven sessions. A single injection of norharman (0.2-20 mg/kg, i.p.) was given 30 min before the onset of the seventh session. It was shown that norharman decreased the cocaine intake in a U-shaped manner with the dose of 10 mg/kg having the most potent effect. These results indicate that several receptor mechanisms mediate the effects of norharman. In addition, 15 min following the administration of norharman on session 7, motor and sensory skill tests were performed. Six naïve animals were tested with the dose, which has the most pronounced effect on cocaine self-administration intake, in order to examine whether the observed effects were due to norharman or due to the combination of norharman and cocaine. It was observed that norharman in both the naïve and cocaine-exposed animals significantly increased the response time in the somato-sensory orienting test. However, only in the naïve animals a significant effect of norharman on the grasp reflex was observed.

Serotoninergic status in patients with hereditary vascular retinopathy syndrome.

AIM/BACKGROUND: In a new autosomal dominant syndrome (which the authors called hereditary vascular retinopathy (HVR)) cerebral ischaemia, Raynaud's phenomenon, and migraine are the most striking features. As serotonin (5-HT) is known to play a role in vasospastic processes, Raynaud's phenomenon, and migraine they wondered whether the serotoninergic status in patients with HVR is different. Therefore, it was decided to investigate some serotoninergic variables in these patients. METHODS: The study was conducted in 12 patients with HVR, 10 relatives, and 19 healthy controls. The levels of intraplatelet and plasma 5-HT were measured, as well as the plasma levels of its precursor amino acid tryptophan and the ratio of tryptophan to the large neutral amino acids, which compete with the transport of tryptophan through the blood-brain barrier. RESULTS: In both the patients with HVR and in nine relative the concentrations of 5-HT in plasma and platelets were significantly lower than in controls. The plasma levels of tryptophan and the tryptophan ratio were also found to be lower in the patient group compared with the control group, but not in the relatives. CONCLUSION: The observed alterations in 5-HT and its precursor tryptophan strongly suggest the existence of a malfunctioning of the serotoninergic system in the HVR syndrome.