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PubMed1993

Evaluation of new in-facepiece sampling procedures for full and half facepieces.

Precision and bias were determined on five different methods of conducting in-facepiece sampling. In-board penetration occurred through fixed, circular, leak geometries positioned at different areas on the face-seal of full and half facepiece negative-pressure respirators. The sampling procedures evaluated in the study were: (1) a continuous, low sampling rate, flush on the respirator, mid nose-mouth probing (CLF) procedure; (2) a continuous, high sampling rate, deep front-of-mouth probing (CHD) procedure; (3) a pulsed exhalation, deep front-of-mouth probing (PED) procedure; (4) an exhalation value discharge (EVD) procedure; and (5) a pulsed inhalation, deep front-of-mouth, probing (PID) procedure. The CLF procedure represents a recommended in-facepiece sampling procedure in the United States. Evaluations were done on populations of nine full facepiece respirators and five half facepieces. The full facepieces were not equipped with nose cups. The average sampling biases on the full facepieces were: (1) CLF procedure, -21%; (2) CHD procedure, -3%; (3) PED procedure, 0.7%; (4) EVD procedure, -14%; and (5) PID procedure, -12.3%. On the five half facepiece respirators the average sampling biases were: (1) CLF procedure, -26%; (2) CHD procedure, -13%; (3) PED procedure, -4%; (4) EVD procedure, -2%; and (5) PID procedure, -24%. The bias observed with each method was found to be affected, to some extent, by the location of the face-seal penetration.

Analysis of Variance↗
PubMed2004

Creation of an innovative inpatient medical procedure service and a method to evaluate house staff competency.

INTRODUCTION: Training residents in medical procedures is an area of growing interest. Studies demonstrate that internal medicine residents are inadequately trained to perform common medical procedures, and program directors report residents do not master these essential skills. The American Board of Internal Medicine requires substantiation of competence in procedure skills for all internal medicine residents; however, for most procedures, standards of competence do not exist. OBJECTIVE: 1) Create a new and standardized approach to teaching, performing, and evaluating inpatient medical procedures; 2) Determine the number of procedures required until trainees develop competence, by assessing both clinical knowledge and psychomotor skills; 3) Improve patient safety. DESIGN: A Medical Procedure Service (MPS), consisting of select faculty who are experts at common inpatient procedures, was established to supervise residents performing medical procedures. Faculty monitor residents' psychomotor performance, while clinical knowledge is taught through a complementary, comprehensive curriculum. After the completion of each procedure, the trainee and supervising faculty member independently complete online questionnaires. RESULTS: During this pilot program, 246 procedures were supervised, with a pooled major complication rate of 3.7%. 123 thoracenteses were supervised, with a pneumothorax rate of 3.3%; this compares favorably with a pooled analysis of the literature. 87% of surveyed house staff felt the procedure service helped in their education of medical procedures. CONCLUSIONS: The "see one, do one, teach one" model of procedure education is dangerously inadequate. Through the development of a Medical Procedure Service, and an associated procedure curriculum and a mechanism of evaluation, we hope to reduce the rate of complications and errors related to medical procedures and to determine at what point competency is achieved for these procedures.

Boston↗
PubMed2000

Prospective evaluation of propofol anesthesia in the pediatric intensive care unit for elective oncology procedures in ambulatory and hospitalized children.

OBJECTIVES: To evaluate our experience with propofol anesthesia delivered by pediatric intensivists in the pediatric intensive care unit (PICU) to facilitate elective oncology procedures in children performed by pediatric oncologists. METHODS: Elective oncology procedures performed with propofol anesthesia in our multidisciplinary, university-affiliated PICU were prospectively evaluated over a 7-month period. Ambulatory and hospitalized children were prescheduled for their procedure, underwent a medical evaluation, and met fasting requirements before the start of anesthesia. Continuous cardiorespiratory and neurologic monitoring was performed by a pediatric intensivist and a PICU nurse, while the procedure was performed by a pediatric oncologist. Propofol was delivered in intermittent boluses to achieve the desired level of anesthesia. Information studied included patient demographics, procedures performed, induction and total doses of propofol used, the duration of the different phases of the patient's PICU stay, the occurrence of side effects, the need for therapeutic interventions, and the incidence of recall of the procedure. RESULTS: Fifty procedures in 28 children (mean age: 7.5 +/- 4.3 years) were evaluated. Sixty-one percent of patients had established diagnoses. Fifty-four percent of procedures were lumbar puncture with intrathecal chemotherapy administration and 26% of procedures were bone marrow aspirations with biopsy. Induction propofol doses were 2. 0 +/-.8 mg/kg for ambulatory and hospitalized patients, while total propofol doses were 6.6 +/- 2.3 mg/kg and 7.9 +/- 2.4 mg/kg for ambulatory and hospitalized patients, respectively. Induction time was 1.5 +/-.7 minutes, recovery time was 23.4 +/- 11.5 minutes, and total PICU time was 88.8 +/- 27.7 minutes. Transient decreases in systolic blood pressure less than the fifth percentile for age occurred in 64% of procedures, with a mean decrease of 25% +/- 10%. Intravenous fluids were administered in 31% of these cases. Hypotension was more common in ambulatory patients but was not predicted by propofol dose, anesthesia time, or age. Partial airway obstruction was noted in 12% of procedures while apnea requiring bag-valve-mask ventilation occurred in 2% of procedures. Neither was associated with age, propofol dose, or the duration of anesthesia. All procedures were successfully completed and there were no incidences of recall of the procedure. CONCLUSIONS: Propofol anesthesia is effective in achieving patient comfort and amnesia, while optimizing conditions for elective oncology procedures in children. Although transient hypotension and respiratory depression may occur, propofol anesthesia seems to be safe to use for these procedures in the PICU setting. Recovery from anesthesia was rapid and total stay was brief. Under the proper conditions, propofol anesthesia delivered by pediatric intensivists in the PICU is a reasonable option available to facilitate invasive oncology procedures in children.

Adolescent↗
PubMed2004

[Sling removal after the Vesica sling and tension-free vaginal tape (TVT) procedures].

PURPOSE: We describe our experience of sling removal performed after either the Vesica sling procedure (due to vaginal erosion or at the time of reoperation for recurrent stress incontinence) or the tension-free vaginal tape (TVT) procedure (due to persistent urinary retention). MATERIALS AND METHODS: From May 1997 to December 2002, we performed 19 Vesica sling procedures and 66 TVT procedures for the treatment of urodynamic stress incontinence. In the former procedures, four patients (21%) developed vaginal erosion and underwent total or partial removal of sling material (Hemashield made from bovine-collagen-injected woven polyester). In another three patients, stress incontinence recurred 2-4 years after the Vesica sling procedure, and they underwent total sling removal and the TVT procedure. Before using the urethral pull-down process (UPDP) in TVT procedures, 2 out of 23 patients (8.7%) developed persistent urinary retention and underwent either sling release alone or partial sling removal concomitant with a second TVT procedure. After the introduction of the UPDP, no patient developed urinary retention. RESULTS: Three patients in whom total sling removal was performed due to vaginal erosion after a Vesica sling procedure developed recurrent stress incontinence. One patient who underwent partial sling removal remained continent, but vaginal erosion recurred 2 years later. Patients who had total sling removal and TVT procedures due to recurrent stress incontinence after Vesica sling procedure became continent with an uneventful postoperative course. One patient who underwent transvaginal release of TVT tape (polypropylene mesh) due to urinary retention after the TVT procedure developed recurrent stress incontinence, and the other who underwent partial removal of TVT tape and a second TVT procedure had resolution of urinary retention without recurrence of stress incontinence. CONCLUSION: Prompt and total sling removal should be recommended for vaginal erosion after the Vesica sling procedure. In patients with urinary retention after the TVT procedure, partial removal of TVT tape and a second TVT procedure using the UPDP to prevent overtightness may be a preferable choice to attain both continence and resolution of urinary retention.

Adult↗
PubMed2006

Efficiency of an endoscopy suite in a teaching hospital: delays, prolonged procedures, and hospital waiting times.

BACKGROUND: Increased demand for screening colonoscopy necessitates improved efficiency in endoscopy units, especially more efficient use of existing resources. The purpose of this study was to assess the efficiency of the endoscopy unit of a large tertiary care teaching hospital. OBJECTIVE: To assess the efficiency of the endoscopy unit in a large tertiary care teaching hospital. DESIGN: Prospective study from May 16 to September 5, 2003. SETTING: Endoscopy unit of a 650-bed acute care teaching hospital. PATIENTS: Inpatient and outpatient procedures. MAIN OUTCOME MEASUREMENTS: Time elapsed between endoscopic procedures; the duration of the procedures; procedure delays (>15 minutes between procedures) and the reasons for them. RESULTS: The research assistant observed 675 endoscopic procedures done for 625 patients (207 inpatients [33%]). The most common procedure was colonoscopy (42.1%), followed by EGD (36.0%). Overall, procedures for 193 (30.9%) of the 625 patients were delayed (>15 minutes between procedures), 70.5% (136/193) because the physician was not available to start the procedure. The time elapsed between procedures was longer than 30 minutes for 47 of the 193 delayed procedures (24.4%). The duration of procedures was prolonged for about 22% (130/593) of procedures. CONCLUSIONS: Physician unavailability contributed to considerable delays in endoscopic procedures. Strategies to reduce procedure delays could have a favorable impact on the volume of procedures performed in the unit, thereby improving the use of existing resources. We encourage other groups to assess the efficiency of their hospital-based endoscopy units.

Canada↗
PubMed2000

Procedural experience and comfort level in internal medicine trainees.

BACKGROUND: The American Board of Internal Medicine (ABIM) has recommended a specific number of procedures be done as a minimum standard for ensuring competence in various medical procedures. These minimum standards were determined by consensus of an expert panel and may not reflect actual procedural comfort or competence. OBJECTIVE: To estimate the minimum number of selected procedures at which a majority of internal medicine trainees become comfortable performing that procedure. DESIGN: Cross-sectional, self-administered survey. SETTING: A military-based, a community-based, and 2 university-based programs. PARTICIPANTS: Two hundred thirty-two internal medicine residents. MEASUREMENTS: Survey questions included number of specific procedures performed, comfort level with performing specific procedures, and whether respondents desired further training in specific procedures. The comfort threshold for a given procedure was defined as the number of procedures at which two thirds or more of the respondents reported being comfortable or very comfortable performing that procedure. RESULTS: For three of seven procedures selected, residents were comfortable performing the procedure at or below the number recommended by the ABIM as a minimum requirement. However, residents needed more procedures than recommended by the ABIM to feel comfortable with central venous line placement, knee joint aspiration, lumbar puncture, and thoracentesis. Using multivariate logistic regression analysis, variables independently associated with greater comfort performing selected procedures included increased number performed, more years of training, male gender, career goals, and for skin biopsy, training in the community-based program. Except for skin biopsy, comfort level was independent of training site. A significant number of advanced-year house officers in some programs had little experience in performing selected common ambulatory procedures. CONCLUSION: Minimum standards for certifying internal medicine residents may need to be reexamined in light of house officer comfort level performing selected procedures.

Adult↗
PubMed1999

Procedural competency in emergency medicine: the current range of resident experience.

OBJECTIVES: To evaluate the recorded range of procedures tracked by emergency medicine (EM) programs, and to determine whether differences in procedural experience occur in various types of residency or hospital settings. METHODS: The program directors of 112 approved EM programs were asked to send actual procedure logs. The requested information included the average total number of a given procedure per graduating resident, for all procedures that were tracked. Data were categorized by program format, hospital type, and ED volume. To assess the global procedural experience among programs, a set of 22 "index procedures" were identified; all procedures the EM residency review committee (RRC-EM) required to be tracked were included in this set. The means per graduating resident for each index procedure were added together to generate a "mean index procedure sum" (MIPS) per graduating resident for each residency program. These MIPSs for a residency were then compared by program format, hospital type, and ED volume. A similar analysis was performed for all resuscitations, and a "mean index resuscitation sum" (MIRS) per graduating resident was generated. RESULTS: An overall response rate of 82% was achieved; a number of programs had not graduated a residency class and were not included. Sixty-five of 85 eligible programs (76%) provided procedural data. The average number of a given procedure per graduating resident (95% CI in parentheses) for selected procedures is as follows: oral intubation 65 (46 to 85), intubation unspecified 75 (62 to 87), nasal intubation 6 (4 to 9), cricothyroidotomy 2 (1 to 2), subclavian catheter 23 (16 to 30), chest tubes 17 (14 to 20), intraosseous line 2 (1 to 3), thoracotomy 3 (2 to 5), and vaginal deliveries 17 (13 to 21). The only statistically significant differences in subgroup comparisons were in diagnostic peritoneal lavage, trauma resuscitations, and pediatric medical resuscitations when compared by postgraduate year format, and intubation-unspecified and cricothyroidotomy when compared by hospital type. There was no statistically significant difference when MIPSs were compared by format, hospital type, or ED volume. CONCLUSIONS: To the authors' knowledge, this is the first study of the range of EM resident procedure experience across the spectrum of EM residency types and settings. Overall, there are few statistically significant differences in procedure experience among different program formats. Similar experiences are recorded in a variety of different hospital types or ED volumes. However, some programs report very limited EM resident experience with selected critical procedures. There is a large variation in the types and numbers of procedures recorded by EM programs.

Analysis of Variance↗
PubMed2006

Procedural skills quality assurance among Australasian College for Emergency Medicine fellows and trainees.

OBJECTIVE: Presently, no objective quality control mechanism exists for monitoring procedural skills among Australasian College for Emergency Medicine trainees. The present study examined trainee and fellow procedural experience and perceived competency, participation in accredited training courses and support for a procedural logbook. METHODS: A cross-sectional mail survey of Australasian College for Emergency Medicine advanced trainees and fellows was performed. Experience and perceived competency in 23 common and important ED procedures were examined. RESULTS: In total, 202 fellows and 264 trainees responded (overall response rate 39.0%). Overall, fellow procedural experience and perceived competency were reasonable. However, some fellows had never performed a number of procedures including some common procedures (e.g. nasal packing, fracture reduction) and there were reports of 'very poor' competency for 17 (73.9%) procedures. Trainee experience and perceived competency were less than the fellows but showed similar patterns. Perceived numbers of each procedure required to achieve competency varied considerably between the procedures and among the respondents. However, there were no significant differences in the perceived numbers reported by the trainees and the fellows (P > 0.05). Variable proportions of trainees and fellows had undertaken courses that incorporated procedural skills training. More fellows (75.7%, 95% confidence interval 69.1-81.4) than trainees (59.9%, 95% confidence interval 53.6-65.8) supported the use of a procedural logbook (P = 0.003). CONCLUSIONS: Lack of experience in some procedures among some fellows, especially commonly performed procedures, might represent a deficiency in existing quality assurance mechanisms for procedural skills training. Greater participation in skills courses, to improve experience in difficult and uncommonly encountered procedures, is recommended. Improved quality assurance mechanisms, including a procedural logbook, should be considered.

Australia↗
PubMed1999

Procedural pain in newborn infants: the influence of intensity and development.

OBJECTIVE: Previous reports have shown that pain is managed inadequately in newborn infants. Ironically, clinicians believe that infants can experience pain much like adults, that infants are exposed daily to painful procedures, and that pain protection should be provided. In adults, a close relationship has been shown in how adults behave in response to pain, how painful they sense the stimulus to be, and physical measurements of the intensity of the stimulus. Whether similar parallels exist in newborn infants has not been examined. If these parallels do not exist in infants, it may help explain why clinicians fail to manage procedural pain in infants more effectively. The objective of this study was to determine whether the magnitude of infants' responses to nursing/medical procedures: 1) differs as a function of the invasiveness or intensity of the procedure; 2) differs as a function of intrauterine (gestational age at birth) and/or extrauterine (conceptional age) development; and 3) parallels the subjective pain ratings of clinicians for those procedures. METHODS: A broad developmental and clinical range of newborn infants was studied shortly before (baseline and preparatory periods), throughout, and shortly after (recovery period) required nursing/medical procedures during hospitalization. Heart rate, oxygen saturation, mean arterial pressure, and behavioral state (percentage of time spent in sleep or in agitation) were measured, and the magnitude of change in each in response to procedures was calculated. Procedures were categorized as mildly, moderately, and highly invasive to examine differences in response magnitude as a function of procedural invasiveness. Responses were compared as a function of prematurity and postnatal age. Clinicians' procedural pain ratings were compared with the magnitude of infants' responses. RESULTS: Of the original 152 infants, 135 were studied at least two times (range 2-27). Significant changes occurred in physiologic and behavioral measures in response to procedures indicative of pain responses. The magnitude of response generally increased with increased procedural invasiveness although there was considerable overlap of magnitude with invasiveness. Both premature and full-term infants differentiated procedural invasiveness. Very premature infants (<28 weeks' gestational age) exhibited increased increments in response magnitude with increasing postnatal age. Clinician's ratings of procedural painfulness were correlated with and predicted the magnitude of heart rate response to individual procedures. CONCLUSIONS: Similar to what has been shown in adults, newborn and developing infants show increased magnitude physiologic and behavioral responses to increasingly invasive procedures, demonstrating that even very prematurely born infants respond to pain and differentiate stimulus intensity. However, the considerable overlap of magnitude with invasiveness suggests that there is not a physiologic or behavioral threshold that clearly marks the presence of pain. Inconsistencies in physiologic and behavioral responses make reliance on a pain index difficult. The best approach may be one of universal precaution to provide pain management systematically to reduce the acute and long-term impact of early procedural pain. development, stimulus intensity, pain response.

Age Factors↗
PubMed2006

Structure of visits persons with diabetes in Croatian family practice--analysis of reasons for encounter and treatment procedures using the ICPC-2.

The reasons for encounter and the procedures conducted during the visit persons with diabetes to family practice have been investigated. Five family practitioners located in two Croatian counties took part in this study. In this study patients with diagnoses E10-E14 according to International Classification Disease-10 (ICD-10), were involved. There were 543 persons with diabetes (women 324) in the total population of 10,150 patients Data were registered according to the International Classification Primary Care-2 (ICPC-2) (components 1-7 for reasons of encounter, and components 2-6 for procedures during the visit), in period october till december 2005. 871 visits of persons with diabetes (average age 65.7 +/- 12.5 were registered. Patients presented in total 1921 reasons for encounter or 2.1 +/-1.1 per visit. Family practitioner made in total 2,341 procedures or 2.6 +/- 1.5 procedures per visit. 85.0% of patients had 1 to 3 reasons for encounter, 78.4% of patients had 1 to 3 procedures per visit. 64.4% of patients with diabetes presented at least one reason for encounter connected to diabetes. The most common reasons for encounter were prescriptions of medication 46.4 per 100 reasons for encounter, the second was dignostic procedure 19.9, request for analysis of findings 11.1, symptoms complaints 11, request for referrals to diagnostic procedures or specialist consultation 8.9 and administrative reuqests 1.6 per 100 reasons for encounter. Family practitioner performed procedure prescriptions of medication 47 per 100 procedures. The second was dignostic procedure 32.8 per 100 procedures, referrals to diagnostic procedures or specialist consultation 14.7 and administrative procedures 1.7 per 100 procedures. From the total number of 100 referrals to specialist, 23 were to diabetologist, 15 to ophtalmologist, 13 to cardiologist. The largest proportion of procedure belong to diabetics 33.8%, followed by the circulatory system 25.4%, musculosceletal 6.9%, symptoms 5.1%, respiratory 4.5%. The reasons for encounter and the procedures conducted during the visit have direct influence to the quality of care for persons with diabetes. It is necessery collecting the data and research in the field of reasons for encounter and procedures during the visit of person with diabetes. The results then can be compared to the results already found in literature.

Aged↗
PubMed2004

Validity of procedure codes in International Classification of Diseases, 9th revision, clinical modification administrative data.

BACKGROUND: Administrative hospital discharge data are widely used to assess quality of care in patients undergoing certain procedures. However, little is known about the validity of administrative coding of procedure data. We conducted a detailed chart review to evaluate the accuracy and completeness of information on procedures in administrative data. METHODS: We randomly selected 1200 hospital separations in the period April 1, 1996, to March 31, 1997, from administrative discharge data of 3 acute adult hospitals in Calgary, Alberta, Canada. Each separation record in administrative data contains up to 10 procedure coding fields. The corresponding medical charts were reviewed for recording presence or absence of procedures. We then determined sensitivity to quantify the accuracy of coding presence of procedures in administrative data when these are present in the chart data (criterion standard). RESULTS: The agreement between the 2 databases varied greatly across 35 procedures studied. The sensitivity ranged from 0% to 94%. Of 6 major procedures studied, validity of coding was generally good, with 5 procedures having coding sensitivity of 69% and over and only 1 (lysis of peritoneal adhesion) with a low sensitivity of 41%. In contrast, many minor procedures had low sensitivities. Of 29 minor procedures studied, sensitivity was lower than 50% for 15 procedures, between 50% and 79% for 10, and 80% and over for 4. CONCLUSION: Validity of information on procedures in administrative discharge data appears to be related to type of procedures. Major procedures that are usually performed in operating rooms are reasonably well-coded. Meanwhile, minor procedures that are routinely performed on wards or in radiology departments are generally undercoded.

Alberta↗
PubMed2004

Long-term complications and definition of failure of neuroendoscopic procedures.

OBJECTS: A lot has been published about neuroendoscopic procedures over the last decade. Most of these publications are about the effectiveness of endoscopic third ventriculostomy, the most frequently performed neuroendoscopic procedure. Little is published about the effectiveness of other, less frequently performed neuroendoscopic procedures. Over the years more reports about the complications of endoscopic procedures are published, but again most of these publications are about endoscopic third ventriculostomy and only a little is presented about the complications of all other neuroendoscopic procedures. Furthermore, most reports are about intraoperative and immediate postoperative complications; only a few reports evaluated the long-term complications of neuroendoscopic procedures. There are also a few publications that analyse the failures of neuroendoscopic procedures but a good definition of failure is not given. The reports mention, again, mainly endoscopic third ventriculostomy procedures, and are mostly directed at the short-term failure rates, defined as the need for a shunt to be placed. Less attention is paid to the effects of the endoscopic procedures in the longer term. Looking at longer terms emphasises the need for a better definition of failure. METHODS: To get more insight into the long-term complications and failures of neuroendoscopic procedures, we reviewed the literature and evaluated our own series of 485 different cranial endoscopic procedures. With the information gathered we tried to answer the questions mentioned above. CONCLUSIONS: Most of the complications of neuroendoscopic procedures are transient, either spontaneously or by medical intervention. Only a few permanent complications are known, in our series 1.6%, and most of them are not typically related to the endoscopic procedure itself but are due to the ventricular approach necessary for and the management of the endoscopy. Mortality rates are less than 1%. A uniform definition of failure cannot be given for all neuroendoscopic procedures, because the procedures are too heterogeneous and the indications are widespread. Failures are mainly diagnosed within a few months of the procedure but neurosurgeons must be aware of failure in the longer term, because if not diagnosed they can give rise to increased morbidity and probably mortality.

Brain Diseases↗
PubMed2001

If the NHS introduced a '50 procedures a year' policy, what proportion of consultant firms would be affected?

BACKGROUND: Governments, insurers, quality assurance agencies and others have used the higher volume = better quality relationship as a basis for health policy. This relationship is probably real enough to justify these policies. However, even if it were not real, there are other reasons why these and other organizations such as the National Health Service (NHS) may favour high-volume providers. This paper attempts to answer the question: 'If, for common elective procedures, the NHS instituted a high-volume purchasing policy that requires consultant firms to perform a minimum of "50 procedures a year", what proportion of consultant firms would be affected?' The aims of this study were to estimate the proportion of NHS consultant firms that perform common elective procedures less than 50 times a year and to estimate the proportion of firms that would have to stop providing these procedures if a '50 procedures a year' purchasing policy were introduced. METHOD: A descriptive analysis was carried out and modelling was performed on data stored in an NHS health episode statistics database of patients treated in West Midlands NHS facilities. For each of 12 common elective procedures we assumed that a volume threshold of at least 50 a year were set, and calculated the proportion of NHS consultant firms undertaking each procedure who performed less than 50 of those procedures each year and the proportion of firms who would have had to stop providing each procedure. RESULTS: All firms performing some procedures, e.g. cataract extraction, did so at least 50 times a year. By contrast, no firm repaired more than 50 recurrent inguinal hernias a year. If a volume threshold of at least 50 procedures a year were set for a basket of 12 common elective procedures, then about 40 per cent of firms would no longer be eligible to provide a procedure. Even if a lower 'one a month' threshold were set, about 20 per cent of firms would still not be eligible to provide that procedure. CONCLUSION: Introduction of a high-volume policy would affect a considerable number of firms, as many NHS consultant firms perform some common elective procedures infrequently. Some consultants would see the introduction of a high-volume policy as an opportunity to further specialize and super-specialize. Others would see it as a policy that restricts them to providing a narrower range of procedures, makes their professional practice less interesting, and reduces their professional autonomy. Postgraduate training institutions need to consider the possibility and implications of high-volume policies, as many junior doctors would probably need to learn to provide a narrower range of skills than at present.

Elective Surgical Procedures↗
PubMed1984

Treatment of essential blepharospasm. I. Comparison of facial nerve avulsion and eyebrow-eyelid muscle stripping procedure.

Benign essential blepharospasm is an incurable disease for which many treatment modalities have been suggested. The two surgical procedures that have been used most commonly are avulsion of the facial nerve and stripping of the protractor muscles of the eyelid and brow. We compare two matched series of 22 patients; one group underwent facial nerve avulsion ("Reynold's" procedure), and the other underwent "muscle stripping" ("Anderson's" procedure). We noted the number of procedures required for the patient to obtain a functional visual result and the side effects produced. Additional surgical procedures required by patients undergoing facial nerve avulsion were additional facial nerve avulsion, repair of ectropion, and correction of dermatochalasis and brow droop. Additional procedures required in patients who had muscle stripping were excision of lower lid orbicular fibers or residual brow fibers. The Reynold group required 16 additional procedures (38 separate procedures) to obtain functional results, as opposed to the four additional procedures (26 separate procedures) required in the Anderson group. Two patients in the Reynold group who needed surgery have not yet undergone it at this writing. If they did, that would boost the total number of procedures to 40. Secondary procedures are needed 4.5 times more often with the Reynold procedure than with the Anderson procedure. The patient's subjective response to and acceptance of the procedure are much greater for the Anderson procedure.

Adult↗
PubMed1989

Regulatory affairs and biotechnology in Europe. II. The CPMP, "High Tech" and Multi-State procedures.

This paper describes the EEC regulatory requirements for the preparation and execution of a community concertation "High Tech" procedure and compares this "High Tech" procedure with the Multi-State procedure. According to a decision of the European Commission enforced in July 1987, medicinal products, derived from high technology methods have been grouped in two categories: A. and B. Category A. concerns biotechnology products made by R-DNA techniques and by manipulation of mammalian cells. Category B. comprises all other products made by high technology. Before applying for an EEC marketing licence (e.g. submission for registration) one must ascertain whether a product is most appropriate in Category A. or B. and one should contact a licencing authority at an early stage to discuss the planned submission. Various procedures for submission have to be followed: 1. for the so-called "High Tech" products and especially products derived from biotechnology with therapeutic applications (Category A.), it is mandatory that one of the Member States accepts the submission. 2. The "High Tech" procedure is derived from the so-called "2-country" (Multi-State) procedure, in which for the latter procedure a marketing licence in one of the Member States (except Portugal) is required before application in other Member States. The Multi-State and "High Tech" (other products: Category B.) procedures are optional. When the procedures are started, all Member States concerned are involved in evaluation of full or abbreviated dossiers through mediation of the European Commission represented by the CPMP (Committee for Proprietary Medicinal Products), Brussels, Belgium. No application for a marketing licence of Category A. products is allowed without mediation of the CPMP. For Category B. products the applicant may opt for a national submission in one or more of the Member States without using the "High Tech" procedure. However, after consultation with the competent authority in one of the Member States, a "High Tech" procedure for Category B. products might still be advisable, but the applicant is not required to follow this procedure. Both the "High Tech" and the Multi-State procedure are currently executed by the mediation of a rapporteur, who liaises with the applicant from the start of the "High Tech" procedure. Ideally, the applicant should contact a licencing authority some 6 to 9 months before an application is planned: to ensure that the near future submission is acceptable. The institution of a rapporteur (appointed by the licencing authority in the country from where the procedure has recently been established) is introduced for the Multi-State procedure.(ABSTRACT TRUNCATED AT 400 WORDS)

Biotechnology↗
PubMed1994

Learning, experience, and self-assessment of competence of third-year medical students in performing bedside procedures.

BACKGROUND: Third-year medical students are expected to perform common bedside procedures as part of their daily ward activities, but there are few programs to teach these skills or document students' abilities to perform them. PURPOSE: In addition to describing the clinical procedures course at the Medical College of Georgia School of Medicine, the purpose of this paper is to report how often students perform common bedside procedures during the third year of medical school, whether the number of times a procedure has been performed is indicative of self-perceived level of competence, and how useful the students find the procedures course for learning how to perform common procedures. METHOD: In June 1991, the 163 entering third-year students participated in a two-day course in which they were taught universal precautions and provided specific step-by-step instructions for performing 16 clinical procedures. One year later, after the students had completed their third-year clerkships, they were asked to report the numbers of times they had performed the procedures during their clerkships, to provide self-assessments of their competency, and to indicate how helpful the course had been for learning clinical procedures. The association between the number of times the students reported performing a procedure and how competent they felt to perform the procedure was assessed using Kendall's tau coefficient. RESULTS: A total of 100 students returned completed questionnaires. Most of the students reported performing venipuncture, obtaining blood cultures, and scrubbing surgically more than five times, but they reported performing other procedures less frequently. For most procedures, self-assessment of competency correlated with frequency of performance. The procedures course was well received by students and instructors, based on both written evaluations and informal verbal feedback. CONCLUSION: Surprisingly, the students' self-reports indicated that many students performed procedures on patients infrequently. As expected, for most procedures there was a significant association between frequency of performance and self-assessed competency.

Academic Medical Centers↗
PubMed1996

Family member presence during pediatric emergency department procedures.

OBJECTIVE: Exclusion of family members (FM) during pediatric procedures in the emergency department (ED) is an accepted practice. This study questions the validity of such a practice. SUBJECTS: FM of ED pediatric patients undergoing procedures and ED staff performing procedures. SITES: ED of a tertiary care university-affiliated community hospital and the pediatric ED of a university hospital. METHODS: Post-procedure surveys were obtained from FM remaining with their child during an ED procedure and from the ED personnel performing the procedures. FM activity during the procedure was also recorded. RESULTS: Ninety-six children (average age 20 months) underwent a total of 127 procedures. ED procedures included: vascular access 91, lumbar puncture 23, urethral catheterization 9, nasogastric tube placement 1, rapid sequence intubation 1, fluid resuscitation from shock 1, and removal of foreign body from eye 1. Three children were critically ill during performance of procedures. ED staff answered 98 surveys concerning the performance of the 127 procedures. FM ACTIVITIES INCLUDED: Stood at bedside 35 (31%), soothed child 21 (19%), and helped restrain child 55 (55%). In 55 (57%) cases the FM was the only adult present with the ED staff member performing the procedure(s). FM MEMBER OPINIONS OF PRESENCE DURING PROCEDURES WERE: Good idea 101 (91%), bad idea 6 (5%), and did not care 4 (4%). ED staff opinions were: good idea 92 (93%), bad idea 2 (2%), and did not care 4 (5%). FM presence made four (5%) members of the ED staff nervous. CONCLUSION: FM presence during ED procedures is a practice favored by both parents and ED staff at our institutions. This practice should not be limited to minimally invasive procedures in stable patients but should be considered for procedures such as lumbar punctures and intubations even in critically ill patients.

Adult↗
PubMed2003

Outcome of continence procedures in the pediatric patient: a single institutional experience.

PURPOSE: Achieving continence remains a major goal in the treatment of children with neurogenic and/or anatomical voiding dysfunction. We reviewed our experience with continence procedures in pediatric lower urinary tract reconstruction. MATERIALS AND METHODS: We reviewed the records of all pediatric patients who underwent continence procedures at our institution since July 1993. We reviewed the diagnosis, type of primary reconstructive procedure, concomitant procedure(s) and initial success rate. In cases of primary failure we noted the type of secondary continence procedure performed and the ultimate success rate. Success was defined as dry intervals of at least 4 hours when the patient was compliant with a catheterization or voiding regimen. RESULTS: Primary continence procedures were performed in 43 cases and secondary procedures were performed in 6 for a total of 49 continence procedures. The diagnoses included myelomeningocele in 22 patients, exstrophy in 12, epispadias in 3, bilateral single system ureteral ectopia in 3 and spinal cord injury in 3. A total of 32 primary procedures were performed concomitantly with or were preceded by bladder augmentation with creation of a catheterizable stoma. The remaining 11 patients underwent a continence procedure only. The diagnosis in these 11 patients was exstrophy in 5, epispadias in 3, with spinal cord injury in 2 and myelomingocele in 1. Mean followup was 35 months (range 1 to 95). Initial continence procedures included Young-Dees-Leadbetter bladder neck repair in 14 cases, of which 11 (79%) were initially successful, a urethral sling in 9 with 7 initial successes (78%), bladder neck division and closure in 7 with all successful (100%), collagen in 5 with 1 success (20%), other urethral lengthening procedure (eg Pippi Salle or Kropp) in 4 with 3 successes, (75%), combined urethral sling and Young-Dees-Leadbetter in 2 with 1 success (50%), and an artificial sphincter and fascial wrap in 1 each, which were successful. Of the 6 secondary procedures performed for primary failure collagen was injected in 4 and the bladder neck was divided and closed in 2. All were successful. CONCLUSIONS: Various lower urinary tract procedures can be performed to achieve successful continence in the pediatric population. At our institution all procedures had a reasonable success rate except primary collagen injection. Collagen injection and bladder neck division/closure proved to be reliable secondary procedures in cases of primary failure.

Adolescent↗