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PubMed1995

Evaluation of clinical trials of agents and procedures to prevent caries and periodontal disease: choosing products and recommending procedures.

The prevention of caries, gingivitis and periodontal diseases has been, and still is, a major objective for the dental profession. A large number of products are available to the general public, either over the counter or on prescription, formulated to prevent these diseases. Formulations are also used by professionals for the prevention and treatment of dental diseases. In recommending or using agents for prevention or therapy it is necessary for the practitioner to appreciate whether proof of efficacy is established. Preventive or therapeutic roles of formulations are frequently confused and there is a need to define the often misleading terminology used to describe products. Guidelines are required to enable the dental professional to understand research data and what constitutes proof of efficacy for preventive and/or therapeutic formulations. The guidelines should describe the research methodologies used today, including study design and analysis, ethics, the format of research papers and the relevance of laboratory data to clinical efficacy.

Anti-Infective Agents, Local↗
PubMed1995

ACC/AHA Task Force Report. Guidelines for Clinical Intracardiac Electrophysiological and Catheter Ablation Procedures. A report of the American College of Cardiology/American Heart Association task force on practice guidelines (Committee on Clinical Intracardiac Electrophysiologic and Catheter Ablation Procedures). Developed in collaboration with the North American Society of Pacing and Electrophysiology.

Explore the source record for details and available documents.

Arrhythmias, Cardiac↗
PubMed1996

[A new procedure for determining leg length and leg length inequality using ultrasound. II: Comparison of ultrasound, teleradiography and 2 clinical procedures in 50 patients].

The clinical methods still in common use for measuring leg length and leg length discrepancy (LLD) cannot always meet the demands of precision and accuracy. A method using ultrasound is presented and shown to be a standardized, non-invasive method allowing accurate determination of leg length and LLD. Once the validity had been proved experimentally, practical handling, precision and accuracy of this method were tested on 50 patients in whom teleradiography of the lower extremity was performed for different reasons. The sonographically determined measures of LLD were compared with the radiographic measurements and in addition clinical measurements were taken by direct (tape measure) and indirect methods ("lengthening" of the shorter leg by wooden blocks of known thickness). Adjustments to the ventral hip joint and to the medial knee joint served as standardized, easily reproducible sonographic reference points. The mean variance of repeated sonographic measurements as a reflection of precision amounted to 3.5 mm2 for leg length measurement, with a maximum of 13.5 mm2. In the case of LLD the mean divergence between sonographically and radiographically determined LLD was 0.9 +/- 2.7 mm, with a maximum of 6.4 mm. The clinical methods with mean divergence of -1.2 +/- 9.6 mm (direct method) and -1.0 +/- 6.1 mm (indirect method) proved to be less accurate. The method examined for measuring leg lengths and LLD by means of ultrasound is easy to manage and non-invasive. Its precision and accuracy make it superior to clinical measuring methods and could even make some radiographical examinations superfluous.

Adult↗
PubMed2005

Hypnosis reduces distress and duration of an invasive medical procedure for children.

OBJECTIVE: Voiding cystourethrography (VCUG) is a commonly performed radiologic procedure in children that can be both painful and frightening. Given the distress that some children experience during the VCUG and the need for children to be alert and cooperative during the procedure, finding a psychological intervention that helps children to manage anxiety, distress, and pain is clearly desirable. This study was designed to examine whether relaxation and analgesia facilitated with hypnosis could reduce distress and procedure time for children who undergo this procedure. METHODS: Forty-four children who were scheduled for an upcoming VCUG were randomized to receive hypnosis (n = 21) or routine care (n = 23) while undergoing the procedure. The sample consisted of 29 (66%) girls and 15 (34%) boys with a mean age of 7.6 years (SD: 2.5; range: 4-15 years). Ethnic/racial backgrounds were 72.7% white, 18.2% Asian, 4.5% Latino, 2.3% black, and 2.3% Filipino. The mean number of previous VCUGs was 2.95 (SD: 2.51; mode: 2; range: 1-15). Potential participants were identified through computerized hospital records of upcoming VCUGs. Parents were contacted by telephone and invited to participate if their child was eligible. To be eligible for the study, the child must have undergone at least 1 previous VCUG, been at least 4 years of age at that time, and experienced distress during that procedure, and both the child and the participating parent had to be English speaking. Each eligible child and parent met with the research assistant (RA) before the day of the scheduled procedure for an initial assessment. Children were queried regarding the degree of crying, fear, and pain that they had experienced during their most recent VCUG. Parents completed a series of parallel questions. Immediately after this assessment, those who were randomized to the hypnosis condition were given a 1-hour training session in self-hypnotic visual imagery by a trained therapist. Parents and children were instructed to practice using the imaginative self-hypnosis procedure several times a day in preparation for the upcoming procedure. The therapist was also present during the procedure to conduct similar exercises with the child. The majority (83%) of those who were randomized to the routine care control group chose to participate in a hospital-provided recreation therapy program (offered as part of routine care). The program includes demonstration of the procedure with dolls, relaxation and breath work training, and assistance during the procedure. On the day of the VCUG, the RA met the family at the clinic before the procedure, and both the child and the parent rated the child's present level of fearfulness. During the procedure, the RA recorded observational ratings of the child's emotional tone and behavior and timed the overall procedure and its phases. Immediately after the VCUG, the child was asked how much crying, fear, and pain he or she had experienced during the procedure; the parent rated the child's experience on the same dimensions and also how traumatic the procedure had been (both generally and compared with their previous one), and the medical staff rated the degree of procedural difficulty. Outcomes included child reports of distress during the procedure, parent reports of how traumatic the present VCUG was compared with the previous one, observer ratings of distress during the procedure, medical staff reports of the difficulty of the procedure overall, and total procedural time. RESULTS: Results indicate significant benefits for the hypnosis group compared with the routine care group in the following 4 areas: (1) parents of children in the hypnosis group compared with those in the routine care group reported that the procedure was significantly less traumatic for their children compared with their previous VCUG procedure; (2) observational ratings of typical distress levels during the procedure were significantly lower for children in the hypnosis condition compared with those in the routine care condition; (3) medical staff reported a significant difference between groups in the overall difficulty of conducting the procedure, with less difficulty reported for the hypnosis group; and (4) total procedural time was significantly shorter-by almost 14 minutes-for the hypnosis group compared with the routine care group. Moderate to large effect sizes were obtained on each of these 4 outcomes. CONCLUSIONS: Hypnotic relaxation may provide a systematic method for improving the overall medical care of children with urinary tract abnormalities and may be beneficial for children who undergo other invasive medical procedures. Because the VCUG is an essential part of the evaluation of urinary tract infections and vesicoureteral reflux in children, lower distress during the procedure may improve patient and family compliance with initial as well as follow-up evaluations. These findings augment the accumulating literature demonstrating the benefits of using hypnosis to reduce distress in the pediatric setting. The present findings are noteworthy in that this study was a controlled, randomized trial conducted in a naturalistic medical setting. In this context, we achieved a convergence of subjective and objective outcomes with moderate to large effect sizes, including those that may have an impact on patient care and procedure cost, that were consistently supportive of the beneficial effects of hypnosis-a noninvasive intervention with minimal risk. The findings, therefore, have immediate implications for pediatric care. Limitations of this study include the lack of participant and staff blindness to the child's condition assignment, which could have introduced bias into reports. However, the objective procedural time differences between groups were consistent with the other, more subjective outcome findings. The sample was also small and primarily white in ethnic/racial makeup, which may have restricted our ability to detect some differences and may limit the generalizability of findings to more representative samples. In addition, the sample comprised children who had already undergone at least 1 VCUG during which they had had difficulty. Consequently, additional research is needed to determine whether hypnosis would be helpful to those who are undergoing their first VCUG. Additional limitations, clinical observations, and directions for future research are also discussed.

Child↗
PubMed2006

Procedure to normalize data for benchmarking.

INTRODUCTION: The hospital billing system is usually the source for reporting activity counts used in benchmarking efforts. Because billing is associated with a specific procedure, benchmarking data are often reported as procedure-days, procedure-shifts, or procedure-hours. Normalizing (usually to procedure-days) is required when comparing data for benchmarking purposes. For an institution that uses hourly billing, simply dividing procedure-hours by 24 (or procedure-shifts by 2 or 3) will underestimate the procedure-days reported by a daily billing system, because daily billing systems use the convention that any fractional day of service is rounded up to the next higher day. The purposes of this study were: (1) to simulate sets of data and determine the expected error with conversion by simple division, (2) to derive a more accurate procedure for normalizing benchmarking data, and (3) to compare the new normalization procedure to simple division, using simulated and actual data. METHODS: A reference population of simulated patient data was created using a spreadsheet to generate random start times paired with actual procedure durations (eg, hours of mechanical ventilation) for 5,000 patients. The spreadsheet calculated "true" billable procedure-days and procedure-shifts from the simulated procedure-hours. Next, a resampling procedure was used to simulate the effect of submitting benchmarking data based on various numbers of patients. The resulting sets of data were used to examine the association between sample size and conversion error when converting from procedure-hours to procedure-days and to generate an alternative conversion procedure that uses linear regression to estimate procedure-days from procedure-hours. An additional regression equation was generated from actual patient data, using simultaneously recorded procedure-hours and procedure-days. The set of mean conversion errors for the 2 regression equations was compared using the Mann-Whitney rank sum test. RESULTS: In general, conversion errors (both systematic and random errors) were smaller with larger sample sizes and with longer service periods, approaching an asymptote at a sample size greater than about 20. Using division, the conversion errors for a sample size of 100 were +/-16% for hourly reporting, +/-11% for 8-hour shifts, and +/-8% for 12-hour shifts. The regression equations for conversion derived from simulated data were as follows. For hourly billing, procedure-days = +/-0.237 + (0.049) (procedure-hours). For 8-hour shifts, procedure-days = +/-0.205 + (0.372) (procedure-shifts). For 12-hour shifts, procedure-days = +/-0.114 + (0.541) (procedure-shifts). Using those regression equations, the conversion errors for a sample size of 100 were +/-1% for hourly reporting, +/-0.2% for 8-hour shifts, and +/-0.2% for 12-hour shifts. The regression equation (for hourly billing) derived from simulated data gave better results than did the equation derived from actual data (median error 0.39 vs +/-2.92, p = 0.013).

Benchmarking↗
PubMed2002

Radiosurgery for residual or recurrent nonfunctioning pituitary adenoma.

OBJECT: Nonfunctioning pituitary adenomas comprise approximately 30% of all pituitary tumors. The purpose of this retrospective study is to evaluate the efficacy and role of gamma knife radiosurgery (GKS) in the management of residual or recurrent nonfunctioning pituitary adenomas. METHODS: A review was conducted of the data obtained in 42 patients who underwent adjuvant GKS at the University of Pittsburgh between 1987 and 2001. Prior treatments included transsphenoidal resection, craniotomy and resection, or conventional radiotherapy. Endocrinological, ophthalmological, and radiological responses were evaluated. The duration of follow-up review varied from 6 to 102 months (mean 31.2 months). Fifteen patients were observed for more than 40 months. The mean radiation dose to the tumor margin was 16 Gy. Conformal radiosurgery planning was used to restrict the dose to the optic nerve and chiasm. Tumor control after GKS was achieved in 100% of patients with microadenomas and 97% of patients with macroadenomas. Gamma knife radiosurgery was equally effective in controlling adenomas with cavernous sinus invasion and suprasellar extension. No patient developed a new endocrinological deficiency following GKS. One patient's tumor enlarged with an associated decline in visual function. Another patient experienced a deterioration of visual fields despite a decrease in tumor size. CONCLUSIONS: Gamma knife radiosurgery can achieve tumor control in virtually all residual or recurrent nonfunctioning pituitary adenomas. Dose sparing facilitates tumor management even when the adenoma is close to the optic apparatus or invades the cavernous sinus.

Adenoma↗
PubMed1994

Influence of demographics and profitability on physician selection of family practice procedures.

BACKGROUND: Family physicians must make complex decisions regarding which procedures to learn in training and which to perform in practice. Factors that influence these decisions include community needs, the potential profitability of a procedure, and the desires and skills of the individual physician. METHODS: To further clarify some of these influences, we surveyed members of the Wisconsin Academy of Family Physicians. The survey instrument included questions about 27 different procedures, including the perceived profitability of the procedure, which procedures they had discontinued, and which they planned to learn. RESULTS: More than 40% of family physicians reported doing skin surgery, flexible sigmoidoscopy, nonstress obstetrical testing, breast-cyst aspiration, multiple joint arthrocentesis, and Norplant insertion, whereas fewer than 6% perform colonoscopy, esophagogastroduodenoscopy, and nasolaryngoscopy. Fifty-seven percent of physicians had discontinued at least one procedure, and 34% planned to learn one or more procedures. Being younger, male, and practicing in smaller communities correlated with performing a greater number of procedures (P < .001), but female physicians performed more gynecologic procedures (P < .05). There was a statistically significant correlation (r = -.478, P < .05) between perceived low profitability of a procedure and family physicians discontinuing a learned procedure, and a marginal correlation between perceived profitability and planning to learn a procedure (r = .338, P < .1). CONCLUSIONS: Family physicians in Wisconsin vary greatly in the number and types of procedures performed. Community size, sex, and age are important variables associated with the number and type of procedures performed. The performance of procedures is dynamic: physicians both discontinue learned procedures and learn new procedures. The profitability of the procedure influences the learning and discontinuation of procedures.

Adult↗
PubMed1993

Anterior and posterior spinal fusion: comparison of one-stage and two-stage procedures.

OBJECTIVE: To compare postoperative morbidity and length of hospital stay after combined anterior and posterior spinal fusion for patients treated by a one-stage procedure and those treated in two stages, 1 to 2 weeks apart. DESIGN: Retrospective review of all cases handled by the first author between July 1989 and November 1991. The patients had been referred for treatment of severe spinal deformity, scoliosis or kyphosis by combined anterior and posterior spinal fusion. SETTING: The operations were performed at McMaster University Medical Centre, Hamilton, Ont., by the first author, who was assisted by another specialist in spinal surgery and a fellow or resident. PATIENTS: Eleven operations of each type were performed. The mean age of the 22 patients was 16.6 and 14.6 years for those who underwent the one-stage and the two-stage procedures respectively. The diagnoses included neuromuscular disease, neurofibromatosis, spina bifida, congenital kyphoscoliosis and severe idiopathic spinal curvature. The one-stage procedure was used after the surgical team became able to provide the care associated with this type of major surgery; selection of patients also involved preoperative risk assessment and the feasibility of combining two surgical procedures that would take a maximum of 9 hours. The preoperative plan was to spend a maximum of 9 hours in performing the one-stage procedure. INTERVENTIONS: Similar surgical procedures were performed in both groups. The average number of intervertebral levels fused during the anterior component of the operation was 4.6 in the one-stage procedure and 6.0 in the two-stage procedure. Thoracolaparotomy was performed in four patients who underwent the two-stage procedure. During the posterior component of the operation, instrumentation was inserted through an average of 11.6 and 12.6 intervertebral levels in the groups undergoing the one-stage and the two-stage procedures respectively. Total operating time averaged 7 hours and 15 minutes for the one-stage procedure and 11 hours for the two-stage procedure. Mean blood loss was 1830 mL for the one-stage procedure and 2270 mL for the two-stage procedure. MAIN OUTCOME MEASURES: The number of days spent in the intensive care unit (ICU) and the total number of days spent in hospital, as well as morbidity after the operation, were determined. RESULTS: Postoperative morbidity included five minor complications in patients who underwent a one-stage procedure; all of these complications resolved well. Among those who underwent the two-stage procedure there were 11 complications; in two patients further surgery was required. The patients' stay in the ICU averaged 2.6 and 7.7 days respectively for one-stage and two-stage procedures, and the total stay in hospital averaged 14 and 33 days respectively. CONCLUSIONS: When possible, the one-stage procedure for anterior and posterior spinal fusion is preferred over the two-stage procedure because of a significant reduction in the length of stay in the ICU and in hospital, as well as reduced morbidity. However, this analysis should be interpreted cautiously because of the small number of cases and the variables encountered in treating this type of spinal deformity.

Adolescent↗