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Quality improvement in laparoscopic radical prostatectomy for pT2 prostate cancer: impact of video documentation review on positive surgical margin.

PURPOSE: We correlated intraoperative video documentation and pathology findings to understand the mechanisms by which positive surgical margins occur and improve the surgical technique. MATERIALS AND METHODS: Between January 2003 and May 2004, 240 consecutive patients underwent laparoscopic radical prostatectomy, of whom 180 had pT2 prostate cancer and represent the population of this study. After the first 90 patients (group 1) we started a quality assurance study, analyzing intraoperative video recordings and correlating them with pathology findings in patients with a positive margin. The cancer characteristics and positive margin rate were compared between the first 90 patients and the subsequent 90 after the study was initiated (group 2). RESULTS: Of the 12 cases of positive surgical margins studied the video review helped identify 8 with a technical error. In all 4 cases in which a technical error could not be identified the positive margin site was at the distal apex. The most frequent identifiable mechanism by which positive margins occurred was a capsular tear during neurovascular bundle dissection. The 2 groups were comparable in regard to preoperative cancer characteristics and total tumor volume. In patients who underwent bilateral nerve sparing the positive margin rate was 10.6% in group 1 and 5.4% in group 2 (p = 0.18). All positive margins in group 2 involved the prostatic apex. CONCLUSIONS: Quality assurance efforts through pathological and intraoperative documentation review can help decrease the positive margin rate, particularly in organ confined disease. However, eradicating positive margins at the distal prostatic apex remains a challenge.

Humans↗

Personal digital assistants used to document compliance of bacterial vaginosis treatment.

OBJECTIVE: The objective of this study was to estimate patient compliance with oral and vaginal metronidazole treatment of bacterial vaginosis using personal digital assistants (PDAs) and paper diaries. GOAL: The goal of this study was to assess a novel compliance documentation approach. STUDY: After each dose of intravaginal or oral metronidazole, 71 subjects recorded the time on a paper diary and answered questions on a PDA. All PDA entries were unknowingly time-date-stamped. Subjects returned for 2- and 6-week posttreatment examinations. Compliance was calculated using a repeated-measures multivariate analysis of variance (ANOVA). RESULTS: Mean patient compliance rates within the oral metronidazole group were greater with the paper diary compared with the PDA (68.3% and 50.0%, respectively, P = 0.001). The observed rate of compliance agreement for PDA versus paper diary was 69.0% (kappa = 0.4). The majority of noncompliant subjects reported they were compliant with the PDA and paper diary. CONCLUSIONS: PDAs could more accurately document true compliance rates and could be reasonable instruments to assess compliance in intravaginal antimicrobial drug or contraceptive trials.

Administration, Intravaginal↗

Documenting neuropathy of the lateral femoral cutaneous nerve using the Pressure-Specified Sensory Testing device.

Entrapment of the lateral femoral cutaneous nerve has been difficult to document. The variability of the anatomic location of this nerve makes it difficult to measure with traditional electrodiagnostic studies. At the same time, anatomic variability increases the likelihood for this nerve to become entrapped within the inguinal ligament. The current study reports the ability to document the presence of this nerve entrapment in 24 patients, compared with 10 asymptomatic control subjects, by using nonpainful and noninvasive computer-assisted neurosensory testing with the Pressure-Specified Sensory Device.

Adult↗

Fatal voluntary salt intake resulting in the highest ever documented sodium plasma level in adults (255 mmol L-1): a disorder linked to female gender and psychiatric disorders.

Excessive ingestion of salt is a well-recognized cause of hypernatraemia in children, is uncommonly recognized in debilitated elderly persons, but is rarely diagnosed in healthy, independent adults. We report a case of fatal salt poisoning in a 20-year-old lady who suffered of post-natal depression and ingested large quantities of salt as part of exorcism ritual. She presented with the highest ever documented serum sodium level of 255 mmol L(-1), associated with severe neurological impairment that was unresponsive to aggressive hypotonic fluid replacement. Post-mortem examination ruled out any other possible probable cause of death. The medical literature was reviewed, and 16 previous cases of severe hypernatraemia in adults secondary to excessive salt ingestion were retrieved. Common features of all reported cases included female gender (95% of cases) and evidence of underlying cognitive or psychiatric disorders (all reported cases). We conclude that women with documented cognitive or psychiatric disorders, in particular depression, are susceptible for psychogenic salt poisoning. Awareness should be raised to the potentially life-risking use of salty beverages as emetics or as part of 'exorcism' rituals.

Adult↗

Computer-based documentation and bedside terminals.

Rising health care costs and the need for enhancing the quality of clinical care are concerns of hospitals throughout the world. Documentation consumes excessive amounts of nursing time and directly influences the quality of clinical practice, research, administration and education. Recent developments in information technology have offered many alternatives to traditional systems of documentation. Many hospitals have installed bedside terminals, but only few have conducted and published studies regarding their implementation. Most of the studies come from the US and report improved quality of care and reduction of nursing expenses. All the relevant studies have design, sample and methodological problems. There is a need for additional systematic studies to prove the actual benefits of the bedside terminals and link them with the outcomes of care. This paper intends to review the literature and discuss the installation, use, results and future directions of the bedside terminals.

Computer Terminals↗

Clinicopathological staging for colorectal cancer: an International Documentation System (IDS) and an International Comprehensive Anatomical Terminology (ICAT).

The purpose of tumour staging for colorectal cancer (CRC) is to help define clinical management, facilitate communication between physicians, provide a basis for stratification and analysis of treatment results in prospective studies, and provide some prognostic information for patients and their families. The World Congresses of Gastroenterology, Digestive Endoscopy, and Coloproctology, Working Party on staging for CRC studied six commonly used systems to review their strengths and weaknesses. Although it was concluded that defining a new staging system was unnecessary, it was recognized that there is a need to define a terminology to describe the full anatomic extent of spread of CRC. Furthermore, we note that there are several additional features, derived from both clinical and pathology information, which have had prognostic significance shown by appropriately constructed multivariate analyses and which can be used to formulate a more accurate prognostic index than that provided by a description of anatomical tumour spread. Thus the Working Party came to two principal conclusions. First, a standard format should be adopted for the collection of the essential data required for prospective studies, and we recommend the 'International Documentation System (IDS) for CRC' for this purpose. Second, a nomenclature which describes the full anatomical extent of tumour spread and residual tumour status in CRC has been defined and should be adopted, from which all currently used staging systems can be derived. We have called this nomenclature the 'International Comprehensive Anatomical Terminology (ICAT) for CRC'. In the event that these recommendations are adopted, we envision that there will be improved clarity in the documentation of treatment outcome for patients with CRC and improved communication of results derived from prospective studies. Furthermore, an acceptance of IDS and ICAT would set the scene to develop a prognostic index for individual patients with CRC by the expansion of anatomical clinicopathology staging information to include additional factors which have independent prognostic significance.

Colorectal Neoplasms↗

Experimental extrahepatic obstruction of portal vein: documentation of histopathological alterations in liver and extrahepatic tissues.

The histopathology of the portal vein in human extrahepatic portal vein obstruction (EHPVO) in the form of cavernomatous transformation of the portal vein is well documented. However, a similar detailed histopathology has not been documented in experimental EHPVO, even though the model has been in existence for many years. An experimental model of EHPVO was created by partial ligation of the portal vein in 20 rats. A control group of 11 sham operated (SO) rats was also studied. Development of portal hypertension was confirmed by measurement of intrasplenic pulp pressure (19.7 + 7.1 cm normal saline vs 12.9 + 1.1 cm of normal saline in SO rats). Histopathological evidence included varices in the oesophagus and congestion in the submucosa and mucosa of the stomach and capillarization of sinusoids in the spleen. Animals were killed at 22-265 days post-ligation. While SO animals showed mild focal sinusoidal congestion and a normal portal vein, the experimental group of animals with EHPVO showed oedema around the portal vein, multiple dilated vascular channels near the hilum resembling cavernomatous transformation and severe sinusoidal congestion. Jejunum and kidneys showed congested veins in the experimental group. None of the SO animals showed this change. Thus experimental EHPVO does reproduce some histological changes observed in human EHPVO.

Animals↗

French adaptation and preliminary validation of a questionnaire to evaluate understanding of informed consent documents in phase I biomedical research.

The content of informed consent documents (ICD) is a crucial element in the process of providing information to participants in biomedical research. Clear comprehension of the information, i.e. the ability to understand its meaning and its consequences, is of utmost importance. The objective of this study was to describe the different steps in the French adaptation and preliminary validation of the Qualité de Compréhension des Formulaires d'information et de consentement (QCFic) questionnaire (http://www.lyon.inserm.fr/cic-grenoble) based on the American Quality of Informed Consent (QuIC) questionnaire. Adaptation and preliminary validation of the QuIC for use in France was composed of five principal steps: translation, scientific validation, lexical validation, edition of gold-standard answers and a pilot study. Each stage was conducted by independent groups of experts, under the coordination of the study board. Thirteen questions were added and one was suppressed. Two steps were required for the scientific validation and for lexical validation, 21 modifications were proposed. Relative to gold-standard answers, the three experts gave the same answer for 24 questions and for nine other questions, two of the three gave identical answers, which were validated by the study board. Results of a pilot study showed a global QCFic score of 88.99 (84.13-90.92) and no specific commentary was made about the content of the questions, so no more modification needed to be made. A preliminary validated French questionnaire, the QCFic, is now available to evaluate the quality of an informed consent document in phase I clinical trials. It is quick and easy to use.

Adult↗

Electrocardiographically documented unnecessary, spontaneous shocks in 241 patients with implantable cardioverter defibrillators.

The incidence and cause of electrocardiographically documented spontaneous implantable cardioverter defibrillator (ICD) discharges for a rhythm other than ventricular tachycardia (VT) or fibrillation (VF) (unnecessary shocks) were determined in 241 patients who underwent ICD implantation between March 1983 and November 1991. During follow-up of 24 +/- 20 months, 54 of 241 patients (22%) received a total of 132 unnecessary ICD shocks confirmed by Holter or telemetry monitoring or stored electrograms (Egs) from the ICD. The rhythm preceding these unnecessary ICD shocks was atrial fibrillation in 30 patients, sinus or supraventricular tachycardia (SVT) in 11 patients, antitachycardia pacing triggered by atrial fibrillation or SVT resulting in VT in 5 patients, nonsustained VT in 3 patients, and normal sinus or pacemaker rhythm in 10 patients. Unnecessary ICD discharges occurred most frequently during the first week after implantation or generator replacement (18 of 54 patients [33%]). Unnecessary ICD discharges could be documented more often by stored Egs in patients with devices with Eg storage capability (Ventritex Cadence, 19 of 54 patients [35%]) than by Holter or telemetry monitoring in patients with devices without Egs storage capabilities (34 of 193 patients [18%], P < 0.01), despite a shorter mean follow-up duration of 14 +/- 9 months versus 26 +/- 21 months, respectively. Only six of 54 patients (11%) in whom unnecessary ICD discharges occurred had recurrent unnecessary shocks during 22 +/- 20 months of follow-up after treatment directed at the cause of the first episode or device reprogramming to preclude non-VT rhythm detection.(ABSTRACT TRUNCATED AT 250 WORDS)

Atrial Fibrillation↗

Beep detection technique for immediate documentation of R wave sensing by an implanted defibrillator.

A technique is described for follow-up clinic evaluation and documentation of R wave detection by an implanted defibrillator that emits audible tones upon magnet application whenever an R wave or other signal is sensed. A circuit comprising an electret microphone, an instrumentation amplifier, a high-pass filter, and an envelope detector is used to generate a signal that may be plotted together with a surface-lead electrocardiogram on a two-channel strip-chart recorder. The resulting plot documents the sensing function of the implanted device and serves as an indication of optimal magnet position. Alternatively, the beep detector output could be used to trigger the inscription of fiduciary markers on a single-channel strip-chart recorder equipped with an auxiliary input for this purpose.

Defibrillators, Implantable↗

Timing of eruption of permanent teeth: standard Finnish patient documents.

Current standards for the eruption of teeth are constructed mostly on the basis of cross-sectional data. The aim here was to analyze the suitability of the standard patient documents created for health center dental care purposes for the collection of longitudinal data on tooth emergence. Copies of the oral health records of the 911 children born in 1970 and 1971 and in 1980 and 1981 living in three rural communities in Finland were re-examined and analyzed using a specially compiled computer program. The means and standard deviations are in line with previous results. The sex difference in emergence timing ranged from 0.1 to 1.0 years for the various teeth. The emergence of the teeth of the second phase of the mixed dentition was later in the children living in an endemic fluoride area, this difference being statistically greater for the boys than for the girls (95% Cl for differences between means was used to evaluate statistical significance). A secular trend in the eruption of permanent teeth was found between 1970 and 1980. Patient documents are shown to be suitable for the collection of longitudinal data on dental emergence.

Adolescent↗

Dentists' perception of their treatment practices versus documented evidence.

OBJECTIVE: To compare the quality of real-life treatment practices to dentists' perceptions of treatment rendered. SETTING: One administrative unit of the Finnish public oral health service. METHODS: The original oral health records of a randomly selected sample of young adults who received treatment during 1994-1996 provided data on actual clinical examinations (n=208), radiographs (n=312), and root canal treatment courses (n=148) carried out by 50 dentists. Dentists' perceptions of the treatment rendered were obtained through a structured questionnaire completed during their working hours in 1996. OUTCOME MEASURES: Criteria for assessing the quality of treatment practices were based on Finnish health legislation, authoritative instructions, and consensus reports. RESULTS: Based on responses, 77% of the dentists followed the prevailing instructions on oral health record keeping (82%, if partial agreement included). Most dentists (88% fully agreed, 95% at least partly) perceived that their knowledge gained through continuing education was being applied in practice; no one answered no. A gap was found between dentists' perception of the treatment rendered and everyday treatment practices as recorded on patient documents. CONCLUSIONS: Overall, dentists' perception of the quality of their treatment practices exceeded that found in patient documents. This gap deserves consideration while planning research, education, or quality-improvement projects that relate to dentists' opinions.

Adult↗

Directory of Internet documents for consumers on quality of care.

Healthcare professionals have an important role in helping patients and families understand the concept of healthcare quality and gain access to available information on quality care. Information about quality of healthcare is available from many reputable sources on the Internet. A resource directory that leads consumers to these sites would be a useful tool for patient education. This article describes (a) the process of retrieving and evaluating Web site documents on quality care, using criteria developed by the Health Information Technology Institute, and (b) the method of organizing them into a logical structure using Mind Map software. The 32 documents that make up the directory are included in a table under subheadings developed with concept mapping.

Directories as Topic↗

Precise radiochromic film dosimetry using a flat-bed document scanner.

In this study, a measurement protocol is presented that improves the precision of dose measurements using a flat-bed document scanner in conjunction with two new GafChromic film models, HS and Prototype A EBT exposed to 6 MV photon beams. We established two sources of uncertainties in dose measurements, governed by measurement and calibration curve fit parameters contributions. We have quantitatively assessed the influence of different steps in the protocol on the overall dose measurement uncertainty. Applying the protocol described in this paper on the Agfa Arcus II flat-bed document scanner, the overall one-sigma dose measurement uncertainty for an uniform field amounts to 2% or less for doses above around 0.4 Gy in the case of the EBT (Prototype A), and for doses above 5 Gy in the case of the HS model GafChromic film using a region of interest 2 X 2 mm2 in size.

Algorithms↗

Quality control and reference guidelines for CLSI broth microdilution susceptibility method (M 38-A document) for amphotericin B, itraconazole, posaconazole, and voriconazole.

Although standard conditions are available for testing the susceptibilities of filamentous fungi to antifungal agents by the Clinical and Laboratory Standards Institute (CLSI; formerly National Committee for Clinical Laboratory Standards) broth microdilution assay, quality control (QC) MIC limits have not been established for any mold-agent combination. This multicenter (eight-center) study documented the reproducibility of tests for one isolate of Paecilomyces variotii ATCC MYA-3630 and 11 other mold isolates (three isolates of Aspergillus fumigatus; two isolates of A. terreus; one isolate each of A. flavus, A. nidulans, Fusarium moniliforme, and F. solani; and two isolates of Scedosporium apiospermum) by the CLSI reference broth microdilution method (M 38-A document). Control limits (amphotericin B, 1 to 4 microg/ml; itraconazole, 0.06 to 0.5 microg/ml; posaconazole, 0.03 to 0.25 microg/ml; voriconazole, 0.015 to 0.12 microg/ml) for the selected QC P. variotii ATCC MYA-3630 were established by the analysis of replicate MIC results. Reference isolates and corresponding MIC ranges were also established for 6 of the 12 molds evaluated. MIC limits were not proposed for the other five molds tested due to low testing reproducibility for these isolates.

Amphotericin B↗

Axonal loss from acute optic neuropathy documented by scanning laser polarimetry.

BACKGROUND/AIMS: Retinal nerve fibre layer analysis by scanning laser polarimetry has been shown to facilitate diagnosis of glaucoma while its role in glaucoma follow up is still unclear. A major difficulty is the slow reduction of retinal nerve fibre layer thickness in glaucomatous optic neuropathy. Eyes of patients were studied after acute retrobulbar optic nerve lesion in order to evaluate the usefulness of scanning laser polarimetry in documenting retinal nerve fibre layer loss over time. METHODS: Five patients who suffered severe retrobulbar optic neuropathy have had repeated measurements of the retinal nerve fibre layer using scanning laser polarimetry at various intervals, the first examination being within 1 week of injury. RESULTS: All eyes showed a marked decrease in peripapillary retinal nerve fibre layer thickness, which followed an exponential curve and occurred predominantly within 8 weeks of injury. Compared to a previous study using red-free photographs, scanning laser polarimetry showed retinal nerve fibre layer loss earlier in the course of descending atrophy. CONCLUSION: Scanning laser polarimetry is useful for early detection and documentation of retinal nerve fibre layer loss following acute injury to the retrobulbar optic nerve. It seems to be a promising tool for follow up of individual glaucoma patients.

Acute Disease↗

Secondary retinal changes associated with choroidal naevi and melanomas documented by optical coherence tomography.

AIMS: To establish the characteristics of secondary retinal changes associated with the presence of choroidal melanomas and choroidal naevi as documented by optical coherence tomography (OCT). METHODS: Twenty patients with untreated choroidal melanoma and 40 patients with presumed choroidal naevi managed by regular observation were included in the study. OCT scans across the surface of the tumour and surrounding tissue were acquired for all participants. The appearance of retinal tissue on the OCT scans was considered to be abnormal if it did not display the well defined band structure characteristic of normal tissue on OCT scans. RESULTS: Serous retinal detachments were observed in all patients with choroidal melanoma and 18 out of 20 also had abnormal retinal structure or intra-retinal splitting in the tissue overlying the tumour. Out of the 40 patients with presumed choroidal naevi, 12 had serous detachments and three had either abnormal retinal structure or intra-retinal splitting overlying the lesion. CONCLUSIONS: Secondary retinal changes associated with choroidal lesions can be documented by OCT. These changes were observed in most patients with choroidal melanoma included in the study group but were far less prevalent in the patients with presumed choroidal naevi. OCT is also able to identify the presence of small serous detachments before they become clinically visible. Follow up of these patients is required to determine whether the OCT results may be of use in the differential diagnosis of small choroidal lesions.

Adult↗

Targeting youth and concerned smokers: evidence from Canadian tobacco industry documents.

OBJECTIVE: To provide an understanding of the targeting strategies of cigarette marketing, and the functions and importance of the advertising images chosen. METHODS: Analysis of historical corporate documents produced by affiliates of British American Tobacco (BAT) and RJ Reynolds (RJR) in Canadian litigation challenging tobacco advertising regulation, the Tobacco Products Control Act (1987): Imperial Tobacco Limitee & RJR-Macdonald Inc c. Le Procurer General du Canada. RESULTS: Careful and extensive research has been employed in all stages of the process of conceiving, developing, refining, and deploying cigarette advertising. Two segments commanding much management attention are "starters" and "concerned smokers". To recruit starters, brand images communicate independence, freedom and (sometimes) peer acceptance. These advertising images portray smokers as attractive and autonomous, accepted and admired, athletic and at home in nature. For "lighter" brands reassuring health concerned smokers, lest they quit, advertisements provide imagery conveying a sense of well being, harmony with nature, and a consumer's self image as intelligent. CONCLUSIONS: The industry's steadfast assertions that its advertising influences only brand loyalty and switching in both its intent and effect is directly contradicted by their internal documents and proven false. So too is the justification of cigarette advertising as a medium creating better informed consumers, since visual imagery, not information, is the means of advertising influence.

Adolescent↗