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Augmentation procedures for control of the generalized family-wise error rate and tail probabilities for the proportion of false positives.

This article shows that any single-step or stepwise multiple testing procedure (asymptotically) controlling the family-wise error rate (FWER) can be augmented into procedures that (asymptotically) control tail probabilities for the number of false positives and the proportion of false positives among the rejected hypotheses. Specifically, given any procedure that (asymptotically) controls the FWER at level alpha, we propose simple augmentation procedures that provide (asymptotic) level-alpha control of: (i) the generalized family-wise error rate, i.e., the tail probability, gFWER(k), that the number of Type I errors exceeds a user-supplied integer k, and (ii) the tail probability, TPPFP(q), that the proportion of Type I errors among the rejected hypotheses exceeds a user-supplied value 0<q<1. Existing approaches for control of the proportion of false positives typically rely on the assumption that the test statistics are independent, while our proposed augmentation procedures control the gFWER and TPPFP for general data generating distributions, with arbitrary dependence structures among variables. Applying the augmentation methods to step-down multiple testing procedures that control the FWER asymptotically exactly at level alpha (van der Laan et al., 2004), yields procedures that also provide exact asymptotic control of the gFWER and TPPFP at level alpha. The adjusted p-values for the gFWER and TPPFP-controlling augmentation procedures are shown to be simple functions of the adjusted p-values for the original FWER-controlling procedure. Finally, two simple conservative procedures are proposed for controlling the false discovery rate.

Journal Article↗

Screening mammography in community practice: positive predictive value of abnormal findings and yield of follow-up diagnostic procedures.

OBJECTIVE: The purpose of this study was to gather from 50 community mammography practices that were included in the National Survey of Mammography Facilities data concerning abnormal findings on screening mammograms to determine the frequency of various recommendations made for patients who had abnormal findings and to compare these recommendations with the frequency with which the procedures were actually performed. We also determined the positive predictive value of screening mammograms (the number of cancers detected per 100 abnormal findings) and the yield (the number of cancers detected per 100 procedures done) of various diagnostic procedures done because of abnormal findings. MATERIALS AND METHODS: We identified 1717 screening mammograms done in the last half of 1991 that had abnormal findings. Radiologic recommendations and follow-up procedures, including repeat standard (screening) mammography, additional mammographic views, sonography, clinical breast examination, needle aspiration, needle biopsy, and open biopsy, were identified for all of the cases from the radiologic records, and follow-up data were obtained from referring physicians. The positive predictive value and yield in the National Survey of Mammography Facilities were compared with data from the mammography screening practice of the University of California at San Francisco (UCSF), a facility noted for its clinical efficiency. RESULTS: We estimate that 11% of all screening mammograms resulted in a recommendation for further diagnostic procedures. These 1717 mammograms with abnormal findings led to the following recommendations and procedures: repeat standard (screening) mammography, 610 (recommended)/635 (performed); additional mammographic views, 785/707; sonography, 400/345; biopsy, 189/229; and needle aspiration, 21/51. More procedures were done than were recommended in some cases because the results of certain procedures often led to the performance of other, additional procedures. The positive predictive value for screening examinations with abnormal findings was 3.5%, and the yield for open biopsy was 21%. In the UCSF data base, the positive predictive value for examinations with abnormal findings was 10%, and the yield for open biopsy was 34%. CONCLUSION: The positive predictive value for examinations with abnormal findings and the yield for diagnostic procedures performed as a result of abnormal findings in 50 community radiologic facilities were higher than those reported in some earlier studies, a fact that raised concern about the induced cost of screening mammography. However, these values were low compared with those in the UCSF data base. This fact was particularly true of repeat standard (screening) mammography.

Adult↗

HIV transmission during invasive radiologic procedures: estimate based on computer modeling.

OBJECTIVE: The primary purpose of this study was to estimate the risk of HIV transmission from physicians to patients during invasive radiologic procedures and to compare this estimate with those previously derived for surgical procedures so that policy on possible practice restrictions can be decided. The risk of HIV transmission from patient to physician, including cumulative career risk for interventional radiologists, was also estimated. MATERIALS AND METHODS: The risk of HIV transmission from physician to patient and vice versa was estimated with computer modeling techniques, using available data on prevalence of HIV infection, rates of injury during invasive radiologic procedures, and risk of viral transmission after an exposure. Cumulative career risk of occupational infection was estimated with a computer simulation model. RESULTS: If the physician's HIV status is unknown, the risk of transmission of HIV to a patient during a procedure is estimated to be 0.03 per million procedures (95% confidence interval, 0-3.8 per million procedures). If the physician is known to be HIV-positive, the risk of transmission to a patient is estimated to be 7.5 per million procedures (95% confidence interval, 0-15.3 per million procedures). The estimated risk of transmission from patient to physician ranges from 0.03 to 7.5 per million for a single procedure, and the cumulative risk of occupational HIV infection over 30 years is estimated to be 0.009-16%. CONCLUSION: The estimated risk of HIV transmission from physician to patient during invasive radiologic procedures is so low that global practice restrictions on HIV-infected interventional radiologists are not warranted. As recommended by the American Medical Association and the Centers for Disease Control, decisions on possible practice restrictions should be made on a case-by-case basis rather than a priori. The risk of HIV transmission from patient to physician is also low, but real. The cumulative career risk of occupational infection with HIV may vary widely based on individual circumstances and the patient population served.

Computer Simulation↗

Carbon dioxide as a contrast agent to guide vascular interventional procedures.

OBJECTIVE: The purpose of this study was to assess the value and limitations of carbon dioxide (CO2) as a contrast agent to guide vascular interventional procedures. SUBJECTS AND METHODS: Twenty-two adults underwent 26 vascular interventional procedures (21 arterial, five venous). We aimed to use only CO2 if possible because these patients had renal insufficiency (n = 21; mean creatinine level, 2.8 mg/dl) or were allergic to contrast material (n = 1). Arterial procedures performed included renal angioplasty or stent (n = 6), iliac angioplasty or stent (n = 5), infrainguinal angioplasty (n = 5), arterial bypass graft angioplasty (n = 3), and thrombolysis (n = 2). Venous procedures included transjugular intrahepatic portosystemic shunt recanalization (n = 3), angioplasty of the venous anastomosis of a thigh dialysis graft (n = 1), and angioplasty of the inferior vena cava (n = 1). RESULTS: Twenty-five of the 26 procedures were successfully performed. Of the 26 procedures, eight required no iodinated contrast material and 11 required less than or equal to 20 ml of contrast material. CO2 proved to be inadequate for the remaining seven procedures. Iliac artery angioplasty or stent placement required an average of 9 ml of iodinated contrast material; infrainguinal angioplasty required an average of 22 ml of iodinated contrast material. CONCLUSION: CO2 can be successfully used as a contrast agent in a variety of vascular interventional procedures. Such procedures can usually be performed in the iliac and infrainguinal arteries using minimal supplemental iodinated contrast material. However, CO2 failed to provide satisfactory guidance in half of the intraabdominal procedures in our study.

Adult↗

Follow-up of University of Virginia experience with the modified Lothrop procedure.

Current surgical treatment of the frontal sinus disease include external approaches to obliterate or ablate the sinus and both external and transnasal methods to restore drainage into the nasal cavity. The original Lothrop procedure resects the medial frontal sinus floor, superior nasal septum, and intersinus septum, creating a large frontonasal communication. However, as described, the external approach used in this procedure often allowed medial collapse of soft tissue and the stenosis of the nasofrontal communication. This report further relates our experience with the modified transnasal endoscopic Lothrop procedure using suction drills for cases in which frontal recess exploration had failed to relieve obstruction of the frontal sinus. We present an update of the University of Virginia experience in performing the modified Lothrop procedure in 20 patients from 10/93 to 4/95. Our findings over the follow-up period (average 12 months) have verified that this procedure is effective, with a 95% patency rate for the surgically enlarged frontal sinus ostium. When compared to osteoplastic flap with fat obliteration, the modified transnasal Lothrop procedure offers the advantages of a less invasive procedure with a shorter and usually no hospitalization, less morbidity, and the increased ability to evaluate post-operatively for recurrent disease. A patient charge analysis was also performed comparing patients undergoing frontal sinus obliteration during the same time period, revealing an additional benefit of decreased patient costs for the modified transnasal Lothrop procedure. None of our patients experienced complications, and all showed significant improvement, if not complete resolution of their symptoms. Although this procedure has produced favorable results, it should be noted that this procedure is technically demanding and will require further long term follow-up to verify its efficacy and proper role in the spectrum of surgical approaches for the treatment of chronic sinusitis.

Adipose Tissue↗

A modified procedure for simultaneous extraction and subsequent assay of calcium-dependent and lysosomal protease systems from a skeletal muscle biopsy.

An extraction and assay system was developed for quantifying endogenous muscle proteases from a single 5-g sample. A single extraction buffer was developed for simultaneous extraction of both calcium-dependent proteases (CDP) and cathepsins. Protease activity determined by the modified procedure was compared to standard procedures currently used in our laboratory. The successful use of the modified procedure on muscle biopsies was verified. Activities per gram of ovine longissimus muscle of CDP system components for 50-g standard and 5-g modified procedures were not different (P greater than .05) for CDP-I (1.16 vs 1.08), CDP-II (.89 vs 1.03), or CDP inhibitor (2.34 vs 2.32), respectively. Activities of cathepsins per gram of muscle for standard and modified procedures were higher (P less than .05) for the modified procedure (cathepsins B + L, 202.0 vs 309.8), but not different (P greater than .05) for cathepsin B (76.6 vs 98.8). Cystatin-like activity was not different (P greater than .05; 3.4 vs 3.2). To test the effect of location within the longissimus muscle on protease activities, 5 g of longissimus muscle was removed immediately postmortem from each of six locations from each side of three steer carcasses. Location within the longissimus muscle had no effect (P greater than .05) on the protease activities measured. Protease activities determined on bovine longissimus muscle biopsies with the modified procedure were similar to immediate postmortem activities. These data verify that the modified procedure was as able to quantify endogenous muscle proteases as the standard procedures and could be used on muscle biopsies. This procedure should be useful in studying the role of endogenous muscle proteases in muscle growth and postmortem proteolysis.

Animals↗

Unconstrained procedures for the estimation of positive definite covariance matrices using restricted maximum likelihood in multibreed populations.

Two unconstrained procedures to ensure that intrabreed and interbreed genetic and environmental covariance estimates for multibreed populations are computed within the permissible ranges were developed. These procedures were called Partial Scoring and Cholesky Maximization. The Partial Scoring procedure uses partial steps to keep estimates of covariance matrices positive definite at each expectation-maximization (EM) iteration, and the Cholesky Maximization procedure achieves the same goal by computing the elements of the Cholesky Decomposition of each intrabreed and interbreed genetic and environmental covariance matrix. Groups of small simulated data sets containing either direct genetic effects of two traits (90 bulls, 13,500 calves) or direct and maternal genetic effects for a single trait (135 bulls, 32,400 calves) were used to test the computational feasibility of these two procedures. The overall means (and ranges) of the numbers of expectation-maximization iterations, times to convergence, and accuracy of estimation were 10 (2 to 184), 26.2 min (4.1 to 773.2 min), and 40.1% (12.7 to 81.9%) for the Partial Scoring procedure and 7 (3 to 37), 16.7 min (9.5 to 64.6 min), and 37.8% (3.1 to 67.8%) for the Cholesky Maximization procedure. Although the overall accuracy of both procedures was similar, the Cholesky Maximization procedure should be preferred because it converged faster and its covariance estimates were less affected by the values of the covariance priors than those computed using the Partial Scoring strategy. Application to large unbalanced multibreed data sets will require an iterative version of these procedures.

Animals↗

Treatment of posterior tibial tendon dysfunction with tendon procedures from the posterior muscle group.

The use of tendons from the posterior muscle group, specifically the FDL, as a means to repair PTTD is useful for the early stages of the deformity. Once the patient has reached the later stages and the foot becomes rigidly deformed with loss of the medial longitudinal arch, however, any attempt to reconstruct the area with tendon work alone fails. Tendon repair, tenodesis, and tendon transfer are attractive treatment options for PTTD, but care should be taken in choosing the correct patient for these procedures. Some authors note that side-to-side tenodesis does not address arch realignment. Other procedures combined with tendon work perhaps can help to reduce the shortcomings of isolated tendon procedures. Subtalar joint arthroeresis in combination with the tendon work seems to solve this problem. The authors have begun to explore this option and have performed this procedure on some patients. It is premature to address the effectiveness of this combined procedure. Similarly, tendon procedures augmented with other soft-tissue-type procedures also remains an option and is mostly ignored in the medical literature. Deland et al experimented with reconstruction of the spring ligament in a cadaver study, and believed that it should be considered in any reconstructive flatfoot surgery. Likewise, Myerson used some capsular reefing of the talonavicular joint in his tendon reconstruction to aid the correction of the forefoot-to-rearfoot relationship. The treatment of the patient with PTTD remains driven by the surgeon's preference, with little scientific research to guide him or her. There is much controversy regarding the efficacy of tendon procedures and the specific surgical technique of each procedure. Some variations may prove inconsequential, whereas others may prove revolutionary. The authors believe that the use of the tendon work as a means of treatment for PTTD is viable alone or in combination with other procedures. Much research is still needed to identify the best technique for each stage of the deformity. Wiekland has attempted to do this, but unfortunately has not offered any long-term follow-up to justify his treatment algorithms. Foot and ankle specialists should strive for clinical research, which allows better understanding of the appropriate treatment options for each progressive stage of PTTD.

Ankle↗

[Comparison of the Bologna and Ingelman-Sundberg procedures for stress incontinence associated with genital prolapse: ten-year follow-up of a prospective randomized study].

OBJECTIVE: Our purpose was to evaluate and compare the long-term results of the Bologna and the Ingelman-Sundberg procedures for the treatment of stress urinary incontinence in women with genital prolapse. PATIENTS AND METHODS: Forty-seven women underwent surgery at the gynecologic division at Dunkirk Hospital, France between January 1989 and August 1990. All patients presented a genital prolapse with a cystocele of at least degree 2 associated with urinary stress incontinence. The subjects were randomly allocated to one of the two procedures. In the clinical incontinence group (28 patients), 12 procedures were Bologna operations and 16 were Ingelman-Sundberg operations. In the potential incontinence group (19 patients), 11 procedures were Bologna operations and 8 were Ingelman-Sundberg operations. Physical examination and urodynamic explorations were performed preoperatively, and 3 months and 1 year postoperatively. A questionnaire was sent to all participating women during the tenth year of follow-up. We obtained 46 answers. RESULTS: Mean follow-up was 9.7 years. The result of the 1-year postoperative evaluation has been previously published. At 1 year, complete cure was achieved in 91.7% of the patients who underwent the Bologna procedure and 93.7% in those who had the Ingelman-Sundberg procedure. At 10 years, the cure rate was 72.7% and 56.2% (p<0.05) respectively. After the first year, the decline in cure rate was twice as fast with the Ingelman-Sundberg procedure than with the Bologna operation. CONCLUSION: The longevity of the Bologna procedure is greater than that of the Ingelman-Sundberg procedure. Recovery rate declines by 20% in 9 years. All results of urinary stress incontinence surgery were good after the first year. One has to wait 5 to 10 years before reliable informative results can be obtained. This fact should be taken into consideration before accepting to use of new procedures.

Female↗

Step-along vergence procedures in stigmatic and astigmatic systems.

The traditional step-along vergence procedure applies to stigmatic systems, that is, systems that are not astigmatic. Computation is disrupted when a focus coincides with a thin lens or refracting surface. A small change to the procedure results in a modified procedure which overcomes the computational problems. The modified procedure is easier to execute than the traditional procedure and allows one to write down useful equations directly. Among the formulae are those for back-vertex power. A step-along vergence procedure also exists for astigmatic systems. It makes use of the dioptric power matrix and the reduced vergence matrix. Computational problems arise when a point or line focus coincides with a thin lens or refracting surface; however they are not overcome by an analogous modification to the procedure. Nevertheless the modified procedure has some advantages including the fact that, as for stigmatic systems, it allows one to write down useful formulae directly. Stepwise calculations of vergence are sometimes performed backward through a system; the advantages and disadvantages described for step-along procedures holds for such step-back procedures as well.

Astigmatism↗

[Personnel exposure during interventional radiologic procedures].

Intervention radiology, known also as intravascular surgery, is a new medical specialisation that develops very rapidly. Radiological procedures performed under fluoroscopy include: dilatation of stenosed vessels, recanalization or vascular embolization and angioanastomosis. Although these procedures have been initiated by radiologists, the majority of them are performed now by physicians who are specialised in medical disciplines other than radiology (cardiologists, vascular surgeons, gastroenterologists, etc.). All these specialists are always aware of the fact that during radiological procedures, both the personnel and the patients are at risk of ionizing radiation. For that reason monitoring of the exposure in this occupational group is of particular importance. Bearing in mind that members of surgical teams are often in direct contact with x-ray tube, it is assumed that routine individual dosimetry of staff occupationally exposed to x-rays do not provide adequate assessment of the exposure risk. This paper describes measurements carried out among operating surgeons who perform the following procedures: cardiological interventions (percutaneous transluminal coronary angioplasty (PTCA) and bypass with preceding coronarography); neuroradiology (aneurysm embolization); and intravascular surgery within abdominal cavity (TIPS, nephrostomy). Dosimetric assessment was carried out in operating surgeons who are exposed mostly among the members of surgical teams as they have to be in direct contact with radiation sources. A comprehensive assessment of exposure included the following measurements: equivalent dose for the hands (measured by a specially designed finger dosimeter); equivalent dose for the trunk protected by a lead apron (a dosimeter placed under apron); and equivalent dose for the neck (a dosimeter placed on the upper, external edge of apron). In addition, a dose product and the surface of primary beam were measured (Diamentor dosimeter, PTW, Frieburg) which allowed to define the correlation between the entrance air kerma, measured with thermoluminscence dosimeters, and the amount of primary radiation emitted during the monitored procedure. In all, the surgical teams were monitored during 42 intervention procedures. The results of the study revealed that an operating surgeon is most exposed. The values of an annual effective dose and an annual equivalent dose for the hands and eyes, estimated for individual procedures, were as follows: (a) cardiological angioplastic procedures: effective dose--25 mSv, equivalent dose for the hands--438 mSv, equivalent dose for the eyes--265 mSv; (b) intravascular angioplastic procedures within the abdominal cavity and neuroradiological procedures: effective dose--4 mSv, equivalent dose for the hands--360 mSv, equivalent dose for the eyes--41 mSv. It should be stressed that the aforesaid maximum doses do not exceed relevant standard annual limits binding in Poland.

Air Pollution, Radioactive↗

[First line endonasal dacryocystorhinostomy Technique and results. Comparison between diode laser and electrocautery instrument. Study based on 422 procedures].

PURPOSE OF THE STUDY: To assess the results of the first procedures of endoscopic endonasal dacryocystorhinostomy (ENL DCR). To study the efficiency of diode laser in this operation versus electrocautery instruments (ECI). DESIGN: Prospective study; comparative study. METHODS: Intraoperative comparison between ECI and diode laser is based on 422 ENL DCR achieved between June 1997 until June 2000. Three hundreds and sixty three procedures were diode laser assisted and 59 procedures were done with the use of an ECI. The diode laser was only used to vaporize nasal mucosa laying on the osteotomy site, to realize partial turbinectomy and to vaporize polyps and synechiae. Intraoperative comparison was based on the followings: frequency and extent of bleeding, quality of visibility, perception of pain during the use of the instrument and duration of the operation. Postoperative comparison is based on 318 procedures. Comparison was based on: frequency of granuloma formation in the nasal mucosa at the site of the osteotomy, frequency of acquired nasal synechiae, frequency of important crusting reaction of the nasal mucosa; success rates after a minimum follow up of 6 months. RESULTS: Intraoperative haemorrhages were fewer and smaller in the diode laser assisted procedures than in ECI assisted procedures; visibility was better with the diode laser; the use of the diode laser was painless versus 24% of patients complaining of pain during the use of electro-cautery. The duration of the procedure was shorter with the diode laser (29'30 vs 37'). In the postoperative follow-up frequency of granuloma formation was equal with the two instruments, synechiae were fewer with the diode laser (11% vs 22%) just like crusting reaction of the nasal mucosa (7% vs 36%). Success rates were similar (diode laser: 91.94% vs EC: 86.66%). CONCLUSION: Because of the effeciency of the vaporization and coagulation, the diode laser, in comparison with the ECI, allows to shorten mean operative time, to improve the visibility and to decrase bleeding. Contrary to EC it's use is painless. Fewer important crusting reactions and fewer synechiae after diode laser assisted procedures tend to prove than postoperative inflammation and surgical trauma are smaller than with ECI. There is no statiscally signifant difference between the success rates of ENL laser diode assisted procedures and ENL ECI assisted procedures.

Age Factors↗

HCV-RNA detection in liver bioptates--a comparison of automatic and 'home-made' protocols combined with a new procedure of HCV-RNA extraction.

BACKGROUND: For HCV-RNA detection in liver tissue a generally accepted reference method has not been established yet. Therefore, we have developed a procedure of HCV-RNA extraction from liver tissue and compared two methods of HCV-RNA detection. MATERIALS AND METHODS: A set of 32 liver biopsy specimens, obtained from chronically HCV infected patients, has been examined. At the time of biopsy, serum HCV-RNA was detectable in 20 patients in RT-PCR automatic Cobas AmplicorTM Hepatitis C assay, ver. 2.0 (Roche Molecular Systems, Inc, Pleasanton, CA, USA) 2 serum samples were negative for HCV-RNA and 10 patients has not been tested. Liver tissue has been homogenized in the presence of CRSR-Green (Fast RNA Kit-Green, Bio101, Inc, Vista, CA, USA) and a mixture of phenol/chloroform/isoamylic alcohol, using a FastPrep homogenizator (Bio101, Inc, Vista, CA, USA). Then RNA has been isolated from the material obtained using the Total RNA Prep Plus procedure (A&A Biotechnology, Gdańsk, Poland). Presence of HCV-RNA was next tested by means either of 'home-made' nested RT-PCR procedure or the RT-PCR automatic Cobas AmplicorTM Hepatitis C assay, ver. 2.0. In case of an inhibition of PCR detected in the first run of automatic assay, both PCR procedures have been repeated. RESULTS: In 5 cases of automatic assay an inhibition of PCR reaction has been detected in the first run, the RT-PCR procedures has been then successfully repeated in the second run. The presence of HCV-RNA in the liver tissues was detected in a total of 22 cases (69%) by mean of automatic assay and in a total of 20 cases (63%) by means of 'home-made' RT-PCR procedure. Except for two cases of HCV-RNA positivity in a biopsy tissue, detected by means of automatic but not 'home-made' procedure, the results obtained employing the methods have been identical. In one serum HCV-RNA positive case, the presence of HCV RNA has not been detected in a liver tissue using both methods. CONCLUSIONS: Our procedure of RNA isolation combined either with automatic Cobas AmplicorTM Hepatitis C assay, ver. 2.0 or 'home-made' RT-PCR procedure may be useful for establishing presence of HCV-RNA in liver tissue. In this combination, the automatic assay seems to be more sensitive than the 'home-made' procedure.

Biopsy↗

Gastric restrictive procedures to treat obesity: reasons for failure and long-term evaluation of the results of operative revision.

BACKGROUND AND OBJECTIVE: Bariatric surgery has included a large number of operative procedures, some of which have become extinct and others, such as gastric restrictive procedures, which continue to be performed. While these operative procedures play an important role in the management of obesity, they are associated with significant failure rates. This study was performed to evaluate the results of operations performed on patients to revise failed gastric restrictive procedures. METHODS: During the past 15 years operative revision of gastric restrictive procedures was performed on 65 patients. The demographic, operative, and postoperative information has been prospectively collected. The patients were divided into 20 non-obese patients who weighed less than 250 pounds (range 90-247 pounds) and 45 obese patients weighing more than 250 pounds (range 256-527 pounds). The primary indications for operation on the non-obese patients were intragastric foreign body, gastric fistula, gastroesophageal reflux, and non emptying gastric pouch. The obese patients underwent revision for gastroesophageal reflux and failure to maintain weight loss. The obese patients frequently had obesity associated health problems including sleep apnea (N = 5), hypertension (N = 6), diabetes (N = 5) and ventral hernia (N = 30). The operative procedures in the non-obese patients consisted of revision of a gastroplasty in two patients, conversion of a gastroplasty to a gastric bypass in 12 patients and revision of a gastric bypass in eight patients. In the obese patient group, eight patients underwent revision of a gastroplasty, 19 patients had a gastroplasty converted to a gastric bypass and 14 patients underwent revision of a gastric bypass. The mean +/- SEM length of follow-up was 57 +/- 8 months. RESULTS: There were two postoperative deaths, one from a pulmonary embolus and one from unknown cause. There was no significant difference regarding the results of the various operations to revise gastric restrictive procedures on the weight of the non-obese patients at long-term follow-up. When obese patients underwent revision of a gastric bypass procedure, they lost 69 +/- 9 pounds which was significantly less than the 82 +/- 12 pounds lost by the patients who underwent revision of a gastroplasty. Conversion of gastroplasty operations to gastric bypass operations in obese patients resulted in the loss of 110 +/- 7 pounds at long-term follow-up. CONCLUSIONS: Revision of gastric restrictive procedures can be performed with durable control of obesity; however, revision of gastric bypass restrictive procedures in obese patients produced the least benefit.

Adult↗

Family presence during cardiopulmonary resuscitation and invasive procedures: practices of critical care and emergency nurses.

BACKGROUND: Increasingly, patients' families are remaining with them during cardiopulmonary resuscitation and invasive procedures, but this practice remains controversial and little is known about the practices of critical care and emergency nurses related to family presence. OBJECTIVE: To identify the policies, preferences, and practices of critical care and emergency nurses for having patients' families present during resuscitation and invasive procedures. METHODS: A 30-item survey was mailed to a random sample of 1500 members of the American Association of Critical-Care Nurses and 1500 members of the Emergency Nurses Association. RESULTS: Among the 984 respondents, 5% worked on units with written policies allowing family presence during both resuscitation and invasive procedures and 45% and 51%, respectively, worked on units that allowed it without written policies during resuscitation or during invasive procedures. Some respondents preferred written policies allowing family presence (37% for resuscitation, 35% for invasive procedures), whereas others preferred unwritten policies allowing it (39% for resuscitation, 41% for invasive procedures), Many respondents had taken family members to the bedside (36% for resuscitation, 44% for invasive procedure) or would do so in the future (21% for resuscitation, 18% for invasive procedures), and family members often asked to be present (31% for resuscitation, 61% for invasive procedures). CONCLUSIONS: Nearly all respondents have no written policies for family presence yet most have done (or would do) it, prefer it be allowed, and are confronted with requests from family members to be present. Written policies or guidelines for family presence during resuscitation and invasive procedures are recommended.

Adult↗

Quality assurance for interventional pain management procedures.

BACKGROUND: Over the last decade various guidelines for quality assurance in pain medicine have been published for cancer pain, acute postoperative pain and other pain conditions. However, quality assurance for interventional pain management procedures has yet to be addressed. An interventional pain program should at least evaluate 1) efficacy of pain relief; 2) complication rate; and 3) patient satisfaction. OBJECTIVE: This study was designed to monitor the quality of interventional pain management procedures in a university teaching hospital. STUDY DESIGN: A prospective survey. METHODS: From January 1, 2004, to June 30, 2004, the quality of interventional pain management procedures in a university teaching hospital in Miami, Florida was monitored. Questionnaires assessing immediate pain relief, patient satisfaction, and complications were provided to each patient and physician immediately after completion of each procedure. Data was collected before patients were discharged. RESULTS: A total of 566 patients with a mean age of 52.9 years participated in the survey. Interventional pain management procedures included epidural steroid injections, facet joint blocks, transforaminal epidural injections, sympathetic nerve blocks, lumbar discography, nucleoplasty, percutaneous disc decompression, spinal cord stimulator trial, and intravenous regional blocks, etc. Among 528 patients who reported their pain scores before and after procedures, 487 (92%) patients reported various degrees of pain relief immediately following their procedures. The average pain score decreased 4.7 on a o to 10 scale after treatment (p < 0.001). No major complications were reported for this group of patients. Among 442 patients who answered the question regarding satisfaction, 406 (91.8%) were satisfied, or highly satisfied, with the immediate outcome of their procedures. CONCLUSION: The results of the current study indicate that quality assurance of interventional pain management procedures in terms of immediate pain relief following the procedure, low complication rate, and high patient satisfaction can be achieved through application of a quality assurance program.

Female↗

Peri-procedural protocols for interventional pain management techniques: a survey of US pain centers.

BACKGROUND: Interventional techniques are now an integral part of chronic pain management. As new procedures are arising at a rapid pace, decisions regarding patient safety and comfort are becoming more challenging. No peri-procedural consensus protocol currently addresses issues such as 1. nulla per os (NPO) status, 2. sedation, 3. monitoring, or 4. recovery. In establishing safety guidelines for interventional pain procedures, the knowledge of current peri-procedural protocols is required. OBJECTIVE: To survey interventional pain practices and to obtain current peri-procedural protocols. DESIGN: We faxed a one-page questionnaire to 105 United States pain practices identified using the directory of the American Pain Society. Fifty-seven academic and private pain practices (54%) responded and were included in the analysis. RESULTS: Monitoring devices such as electrocardiogram (EKG), blood pressure, and pulse oximetry are not universally employed for cervical or lumbar spinal procedures. Even procedures that are often performed by anesthesiologists in operating rooms, such as Bier blocks, are not monitored in a uniform manner when performed in pain clinics. Establishment of intravenous access for procedures also varies among practitioners. Most (72%) practices had treated patients with vasovagal reactions over the past 12 months, but only 42% had simulated cardiac arrests to prepare for these situations. CONCLUSION: While various trends in peri-procedural care are observable, standards of care are not well established. In order to minimize complications associated with interventional pain management techniques, the pain management community should agree on safety guidelines for all procedures, much as these advocated by the American Society of Anesthesiology for surgical anesthetic care.

Journal Article↗

Informed consent in interventional spine procedures: how much do patients understand?

BACKGROUND: One of the most important issues that interventional physicians address during treatment is informing patients of their treatment options. Prior to beginning treatment, patients are given this information and allowed the opportunity to ask questions. Minimal qualitative information exists as to how much of this material patients retain and understand. OBJECTIVE: To determine the understanding and satisfaction patients have with the information provided through the informed consent process for interventional spine procedures. DESIGN: Prospective qualitative interview study. SETTING: University-based multidisciplinary spine practice. PARTICIPANTS: Twenty-five consecutive patients undergoing spinal procedures who agreed to be interviewed about the informed consent process. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Domains of concern for patients undergoing spinal procedures were determined through a qualitative interview. RESULTS: Primary areas of concern for patients with the informed consent process centered on their desire for more information on the procedure and its risks, expectations of the procedure and benefits, and what treatments patients feel are effective. Patients had difficulty recalling the potential risks and alternatives to the procedure. The majority of patients had tried physical therapy and medications, without benefit. The most common suggestion patients gave for improving the process was to produce a video of the procedure. Common themes encountered during the interview are reviewed, with common phrases presented for each theme. CONCLUSIONS: Despite discussion in the office, handouts, and pre-procedure instructions, patients felt that additional sources of information would be useful to fully understand the procedure and its risks, benefits, and alternatives. Moreover, informing patients' family members may enhance comprehension of all aspects of information provided within the informed consent process about interventional spine procedures.

Journal Article↗