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Is genomic evaluation feasible in endoscopic studies of Barrett's esophagus? A pilot study.

BACKGROUND: The global gene expression in Barrett's esophagus (BE) in comparison to adjacent or histologically similar tissues has not been extensively studied. OBJECTIVE: To test the feasibility of conducting gene arrays in endoscopically obtained mucosal specimens. DESIGN: Cross-sectional feasibility study. SETTING: The Houston Department of Veterans Affairs Medical Center. PATIENTS: We collected endoscopic biopsies from BE, normal esophagus, antrum, duodenum, and sigmoid colon from 5 patients with BE. RNA was extracted and subjected to cDNA microarrays and gene expression was compared between BE and control tissues. Reverse transcription-PCR was conducted to confirm some of the findings. MAIN OUTCOME MEASUREMENTS: Gene expression profiles in BE tissues and 4 control sites: squamous esophagus, antrum, duodenum, sigmoid colon. RESULTS: On average, 2 biopsies by disposable jumbo biopsy forceps provided approximately 5 microg required for microarrays. From the original number of 22,283 gene probes, 13,805 genes had a quality score of P < .05 and were subjected to further comparison. BE gene expression clustered most closely with that of antrum and least closely with squamous esophagus. Of the 587 genes that had significantly different expression between BE and duodenum, 246 were upregulated and 341 were downregulated in BE. The expression of genes involved in apoptosis, negative regulation of apoptosis, and inflammatory response was significantly lower in BE compared to squamous esophagus. None of the gene groups were significantly overexpressed in BE compared to squamous esophagus or antrum. The reverse transcription-PCR confirmed the results of microarrays. LIMITATIONS: Small sample size. CONCLUSIONS: Microarray-based studies are feasible in endoscopically obtained tissues. Differences in gene expression could identify potential markers and shed light on the pathogenesis of BE.

Aged↗

The feasibility of a randomised, placebo-controlled clinical trial of homeopathic treatment of depression in general practice.

UNLABELLED: Depression is common in general practice and lack of concordance is an important problem in its treatment. Homeopathy has few side effects and is generally associated with good compliance. We report a study investigating the feasibility of a trial to compare the effectiveness of homeopathy with a conventional antidepressant and placebo. OBJECTIVES: To assess the feasibility of a general practice-based clinical trial comparing the effectiveness of individualised homeopathic treatment vs Fluoxetine (Prozac) vs placebo in the treatment of major depressive episodes of moderate severity. DESIGN: Randomised, double-dummy, double-blind parallel group clinical trial. SETTING: Lower Clapton Group Practice, East London. METHOD: Patients were recruited through their general practitioners as they presented during a 9 month period. Recruitment target was 30 patients. Eligibility was confirmed by a consultant psychiatrist using standard criteria (DSM-IV) and instruments Hamilton Depression Scale (HAMD). Suicidal and psychotic patients were excluded, additional precautions against suicide were incorporated. There was a 1 week run-in period and patients showing spontaneous improvement were excluded. Homeopathic treatment was prescribed by a GP qualified in homeopathy, from a 'limited list' of 30 homeopathic medicines, with the help of decision support software. Patients were randomised to receive verum Fluoxetine and placebo homeopathy, or verum homeopathy and placebo Fluoxetine, or placebo homeopathy and placebo Fluoxetine. Treatment duration was 12 weeks. The outcomes were: adverse drug reactions, clinical global impression (CGI); HAMD; mini international psychiatric Interview; Pittsburgh sleep quality index; Side-effects checklist; Short Form 12; treatment credibility questionnaire; work and social disability scale. The primary outcome measures were HAMD and CGI. RESULTS: A recruitment calculation indicated that over 230 suitable patients would be expected to attend the practice during the recruitment phase. Thirty one patients were referred for possible inclusion in the trial by their GPs. Twenty three met the entry criteria, 11 were randomised and 6 completed the study. Of the completers, one received homeopathy, 2 placebo and 3 Fluoxetine. CONCLUSIONS: A trial of this design in general practice is not feasible, because of recruitment difficulties, many of them linked to patient preference. Different approaches are required to recruit adequate patient numbers to trials of this sort.

Adult↗

Feasibility and validation of registration of three-dimensional left atrial models derived from computed tomography with a noncontact cardiac mapping system.

OBJECTIVES: The purpose of this study was to determine the feasibility and assess the validity of registering three-dimensional (3D) models from computed tomographic (CT) images using a cardiac mapping system. BACKGROUND: Registration of 3D anatomic models with an interventional system could help identify and navigate mapping and ablation catheters over a complex structure such as the left atrium (LA). METHODS: ECG-gated, contrast-enhanced cardiac CT imaging was performed in 14 patients with atrial fibrillation. Segmentation was used to create 3D models of the LA. The 3D models were registered with the mapping system using a series of fiducial points. Registration was accomplished retrospectively in the first 10 patients, and catheter navigation was visualized from recorded data. In the final four patients, registration was accomplished in real time during electrophysiologic study. The mapping catheter position, as it was navigated inside the LA, was applied to the registered model in real time. For the validation study, temporary pacing leads were implanted in the LA of 10 dogs. Following this, CT scanning, segmentation, LA model importation, and registration was described previously. After registration, a mapping catheter was positioned at the site of each buried lead according to the registered model with no fluoroscopic guidance. A radiofrequency lesion was created at this location, and the dog was sacrificed, the heart removed and stained, and the distance between the buried lead and the lesion measured. RESULTS: During the feasibility study, the location of the catheter in the registered model correlated with fluoroscopy, angiography, and intracardiac electrograms. LA endocardial potentials during sinus rhythm and any premature atrial contractions also were successfully delineated over the registered models. In the validation study, the mean target registration error was 2.0 +/- 3.6 mm. CONCLUSIONS: Registration of CT-derived 3D models of the LA using a cardiac mapping system is feasible and accurate.

Animals↗

Evaluation of the feasibility and acceptability of an oral care diary by patients during chemotherapy.

BACKGROUND: A significant proportion of patients undergoing chemotherapy for many cancer types may experience oral problems, such as mucositis and any deterioration in the health of the oral cavity can have a significant effect on a person's well-being. Trends towards shorter hospital stays and the increase in out-patient chemotherapy mean that patients are required to adopt increasingly participatory roles in their self-care and are subsequently coping with mouth problems while they are at home without the direct support of oncology health professionals. OBJECTIVES: This study aimed to evaluate the acceptability and feasibility of an oral care diary by patients receiving chemotherapy. DESIGN: An oral care diary was developed to incorporate oral assessment using the Oral Assessment Guide (Eilier, J., Berger, A., Peterson, M., 1988. Development, testing and application of the oral assessment guide. Oncology Nurse Forum 15, 325-330) and guidance about oral self-care. This exploratory study utilised purpose designed pre- and post-study questionnaires and semi-structured interviews to evaluate patients' perceptions and experiences of the oral care diary. SETTING: The study took place in 2-day chemotherapy units in Scotland: 1 in a cancer centre and 1 in a district general hospital. PARTICIPANTS: A consecutive sample of patients (n=45) receiving out-patient chemotherapy for a range of cancer diagnoses participated in the study over 2 cycles of chemotherapy. METHODS: Following recruitment, patients were instructed in the use of the oral care diary to assess their mouth daily while at home on a daily basis. Patients were asked to complete 2 structured purpose designed questionnaires-the first prior to starting diary completion and the second following their participation in the study. Nine patients participated in semi-structured interviews to explore their actual experiences of using the oral care diary in more depth. RESULTS: The participants found the oral care diary acceptable and feasible. Awareness of oral symptoms and related mouth self-care post-chemotherapy improved. CONCLUSIONS: The oral care diary is an acceptable and feasible method of enhancing oral self-care during a course of chemotherapy. Further study is required to evaluate its impact on clinical outcomes.

Adaptation, Psychological↗

The delivery of IMRT with a single physical modulator for multiple fields: a feasibility study for paranasal sinus cancer.

PURPOSE: This study describes a new intensity-modulated radiation therapy (IMRT) delivery method that utilizes a single modulator to deliver multiple fields ("multifield modulator"). This technique reduces the treatment time and manufacturing costs typically associated with modulator-IMRT. Technical feasibility was evaluated for treating paranasal sinus cancers. METHODS AND MATERIALS: Technical feasibility was measured by three criteria: The dose distributions of the multifield modulator-IMRT plans should offer improvements over those produced by 3D conformal plans and be equivalent to those of step-and-shoot multileaf collimator (MLC) IMRT plans, the manufactured modulators should meet quality assurance specifications, and the effort required to use this technology should not substantially exceed the effort required for current IMRT practice. Seven paranasal cancer cases were examined. The Wilcoxon signed rank test was used for statistical analysis. RESULTS: Multifield modulator-IMRT plans can improve target coverage while reducing critical structure doses compared to 3D conformal plans. Multifield modulator-IMRT plans are at least equivalent to the corresponding step-and-shoot MLC-IMRT plans. Multifield modulators can be constructed to meet design specifications in quality assurance tests. The time required for manufacturing, quality assurance, and treatment delivery using multifield modulators was measured and found to be only slightly greater than that for current IMRT treatment methods. CONCLUSIONS: IMRT treatments using multifield modulators for paranasal sinus tumors are feasible. Clinics may find it worthwhile to commit the minimal extra time for quality assurance and treatment to benefit from the improved dose distribution and lack of interplay between MLC leaf motion and internal target motion.

Feasibility Studies↗

The Vienna applicator for combined intracavitary and interstitial brachytherapy of cervical cancer: clinical feasibility and preliminary results.

PURPOSE: The aims of this study were to investigate the clinical feasibility and to report on preliminary treatment outcomes of combined intracavitary/interstitial brachytherapy, using a novel applicator and magnetic resonance imaging (MRI)-based treatment planning in patients with locally advanced cervical cancer. METHODS AND MATERIALS: A total of 22 cervical cancer patients with insufficient response and/or unfavorable topography after external-beam irradiation were included in this study. Parametrial extent of the disease in these patients was judged to exceed the coverage limit of intracavitary brachytherapy alone. A modified tandem/ring (T/R) applicator for guidance of parametrial needles (N) was used to perform high-dose-rate-brachytherapy with MRI-based treatment planning. Clinical feasibility and preliminary treatment outcomes were assessed. RESULTS: A total of 44 interstitial needle implants were performed. The spatial relations between the T/R + N applicator, high-risk clinical target volume, and organs at risk were visible clearly in all cases. Accurate and reproducible needle placement could be achieved in the majority of cases. No severe adverse events were caused by the intervention. The mean follow-up period was 20 months (range, 5-35 months). No G3 to G4 early or persistent late side effects were observed. Complete remission was achieved in 21 patients (95%). One local recurrence was observed within the high-risk clinical target volume area during follow-up. CONCLUSIONS: Our preliminary clinical experience indicates that combined intracavitary and interstitial MRI-based brachytherapy in patients with significant residual disease after external-beam therapy extending up to the distal third of parametria is feasible and allows excellent local control and a low rate of morbidity.

Adult↗

A universal product code scanner is a feasible method of measuring household food inventory and food use patterns in low-income families.

This study assesses the feasibility of using a Universal Product Code (UPC) scanner to record the home food inventory of limited-resource families. Feasibility was based on UPC scanner accuracy, time involved, and researcher/study participant feedback. Program staff members completed a traditional line-item inventory and UPC scan of 5,920 food items during 51 separate visits to the homes of 32 families. Foods reported from the UPC scanner were compared with the manual line-item food inventory. The UPC scanner report had an accuracy of 95.6% (5,661/5,920). Further, the UPC scanning technique offered a 31.8% time savings over the traditional line-item inventory approach. The UPC scanner was easy to use and participants reported that scanning food items was non-intrusive. A UPC scanner is a feasible method of recording the home food inventory, and the accuracy and simplicity of this approach can provide useful information on foods available for consumption within a home.

Electronic Data Processing↗

Feasibility of combining multi-channel functional neuromuscular stimulation with weight-supported treadmill training.

More than 3 million stroke survivors live with residual disabilities and mobility deficits even after rehabilitation. Therefore, it is important to develop new, more effective, gait training methods. The purpose of this study was twofold: (1) testing the feasibility of combining multi-channel functional neuromuscular stimulation (FNS) using intramuscular (IM) electrodes and body weight supported treadmill training (BWSTT) for gait training; and (2) documenting the potential gait practice advantages afforded by combining FNS-IM and BWSTT. Eight subjects with gait deficits in the chronic phase (>12 months) were enrolled. Intramuscular electrodes were placed in the paretic hip abductors, knee flexors and extensors, and ankle dorsiflexors, plantarflexors, and evertors. Subjects were treated with exercise and gait training using the combined technologies 1 1/2 h/week, four times/week, for 12 weeks. Feasibility was tested according to performance of the technologies, clinician skill factors, and subject satisfaction. Impairment, function, and quality of life were measured. Provision of practice for eight gait characteristics was catalogued. We found the following results for the combined technologies: (1) the combined technologies were safe and feasible; (2) clinicians required five training sessions to reach proficiency; (3) subjects were satisfied; (4) there were significant gains in impairment and functional measures; (5) a greater number of gait practice characteristics were provided with the combined technologies than with either alone.

Aged↗

Nondominant Hand Training in Laparoscopy for Surgical Interns: Feasibility and Impact.

OBJECTIVE: Laparoscopy requires bimanual proficiency, yet early trainees demonstrate underdeveloped nondominant hand (NDH) performance. Although deliberate practice of NDH skill contributes to overall performance, NDH training is rarely incorporated into residency simulation curricula and has not been formally evaluated in surgical trainees. We assessed feasibility and impact of integrating structured NDH training with established laparoscopic curriculum for surgery interns. DESIGN: Prospective, single-institution randomized pilot study. Interns were assigned the standard 4-week curriculum of laparoscopic dominant hand and bimanual tasks (Control) or completed assigned NDH tasks in addition to the standard curriculum (Intervention). Feasibility was determined by assigned task completion, daily standard and NDH-specific self-reported practice time, and improvement in bimanual task performance. Performance was video recorded weekly and assessed by blinded evaluators using MISTELS and GOALS scoring. Cognitive workload during laparoscopic tasks was measured via NASA-TLX. Exploratory analyses were conducted within a Bayesian framework. SETTING: A single academic institution with a surgical simulation training program. PARTICIPANTS: General surgery interns on their 4-week simulation rotation. RESULTS: Eleven general surgery interns (6 intervention, 5 controls; all right-hand dominant) completed the study with 100% task completion and practice log compliance. Both groups improved in bimanual performance and perceived cognitive load. Reduction in cognitive workload during bimanual task performance was greater in the NDH group. Time spent on NDH practice over 4 weeks was associated with improved bimanual performance, independent of time spent on standard curriculum tasks. CONCLUSIONS: Structured NDH training is feasible to implement within an existing curriculum and reduces perceived cognitive workload during bimanual laparoscopic tasks. NDH practice demonstrates a beneficial dose-response relationship with performance, supporting its integration into early laparoscopic training.

Laparoscopy↗

Epicardial potential distribution reconstruction from recordings of intravenous and transthoracic mapping catheters: a feasibility study.

Catheter-based epicardial mapping is possible with two access methods: transthoracic pericardial access and transvenous access. Transthoracic pericardial access is based on the introduction of the catheters into the pericardial space using a percutaneous subxiphoid puncture and may at times require lengthy sequential mapping procedures. From the transthoracic pericardial approach major regions of the epicardium may also be inaccessible. Transvenous access uses the multielectrode (4-20 electrodes) catheters placed in the coronary veins thus increases the speed of the mapping procedure, however, leaves most of the epicardium inaccessible to direct measurement. The aim of this present study is to demonstrate that the reconstruction of the high-resolution maps using sparse measurements from different sites on the epicardium and on the multielectrode catheters is possible with a reasonably high accuracy in terms of locating the origin of the ventricular arrhythmia. In this study we investigated strategies for the reconstruction of epicardial potential distribution from recordings of intravenous and transthoracic epicardial mapping catheters, alone and in combination. For this purpose, we first examined the problem of best number of epicardial measurement sites (or best sampling resolution) using transthoracic mapping catheters and secondly studied the feasibility of the combined usage of both mapping approaches. In the prediction of the surrogate measurements at inaccessible sites from the measurements localized to the cardiac veins and sparse epicardial sites we evaluated two prediction methods: the Laplacian interpolation and statistical estimation, to overcome the sparsity of the measurements. We performed 14 dog experiments with various interventions to create a high-resolution epicardial potential map database. This database included a total of 592 beats which were recorded using a sock array placed on the ventricles of dog hearts. We found that 2 cm sampling resolution is quite feasible, which means that the time for the mapping procedure may be reduced considerably. Predictions from the combination of 21 intravenous catheter leads and 30 transthoracic catheter leads were better than when only 21 or 30 leads were used. The results of this study encourage further investigation and provide adequate evidence that an epicardial mapping approach based on the combined usage of transvenous and transthoracic pericardial access methods for the mapping of the outer surface of the heart is feasible and can provide adequate accuracy for clinical applications.

Algorithms↗

A feasibility study of in vivo T1rho imaging of the intervertebral disc.

PURPOSE: Recent studies have proposed that magnetic resonance (MR) T1rho relaxation time is associated with loss of macromolecules. The depletion of macromolecules in the matrix of the intervertebral disc may be an initiating factor in degenerative disc disease. The purpose of this study was to test the feasibility of quantifying T1rho relaxation time in phantoms and intervertebral discs of healthy volunteers using in vivo MR imaging at 3 T. MATERIALS AND METHODS: A multislice T1rho spiral sequence was used to quantify T1rho relaxation time in phantoms with different agarose concentrations and in the intervertebral discs of 11 healthy volunteers (mean age=31.3 years; age range=23-60 years; gender: 5 females, 6 males). RESULTS: The phantom studies demonstrated the feasibility of using spiral imaging at 3 T. The in vivo results indicate that the median T1rho value of the nucleus (116.6+/-21.4 ms) is significantly greater (P<0.05) than that of the annulus (84.1+/-11.7 ms). The correlations between the age of the volunteers and T1rho relaxation time in the nucleus (r2=-0.82; P=0.0001) and the annulus (r2=-0.37; P=0.04) were significant. A trend of decreasing T1rho values from L3-4 to L4-5 to L5-S1 was evident. CONCLUSION: The results of this study suggest that in vivo T1rho quantification is feasible and may potentially be a clinical tool in identifying early degenerative changes in the intervertebral disc.

Adult↗

Foot exercise plus education versus brief advice for the treatment of plantar heel pain (FEET Trial): a feasibility randomised controlled trial.

BACKGROUND: Despite foot muscle strengthening being a target of exercise interventions for plantar heel pain (PHP) no study has measured foot muscle outcomes, and existing research is limited by a lack of control (no treatment) comparisons. OBJECTIVES: To determine the feasibility of conducting a randomised controlled trial and investigate the acceptability and credibility of comprehensive progressive foot exercise and education compared to brief advice for PHP. DESIGN: Randomised parallel group feasibility trial. METHOD: People with PHP were randomised (1:1 concealed allocation) to receive either foot exercise plus education or brief advice for twelve weeks. Primary outcomes included willingness to enrol, recruitment rate, adherence, logbook completion, dropout rate, early withdrawal reasons, adverse events, additional treatments sought, and credibility/expectancy. RESULTS: Twenty people with PHP (16 women; age 50&#x202f;&#xb1;&#x202f;9 years; body mass index&#x202f;=&#x202f;30.7&#x202f;&#xb1;&#x202f;4.6&#x202f;kg/m2) were recruited over 15 weeks (1.3 participants per week). Primary outcomes were willingness to enrol (80%), adherence (physiotherapy sessions attended: foot exercise plus education 85%, brief advice 100%; home exercise program: 62% daily sessions completed, 72% thrice weekly sessions completed), logbook completion (foot exercise plus education 75%, brief advice 90%), dropout rate (15%), and additional treatments sought (69%). There were no intervention-related adverse events, and credibility scores were higher for foot exercise plus education. CONCLUSIONS: This study confirms feasibility and acceptability of a protocol comparing foot exercise plus education with brief advice in individuals with PHP, generating key insights to inform future trial design.

Humans↗

Management of acute dyspnoea: use and feasibility of brain natriuretic peptide (BNP) assay in the prehospital setting.

STUDY OBJECTIVES: Diagnosis of acute left ventricular failure (LVF) is often difficult in the prehospital setting. Brain natriuretic peptide (BNP) is a marker of LVF. The object of this study was to evaluate the feasibility of BNP measurement during the prehospital management of patients with dyspnoea. DESIGN: Prospective feasibility study, in the Paris Emergency Medical Service (SAMU). PATIENTS: All patients, aged 50 years and over, presenting with acute dyspnoea were included in the study, unless the dyspnoea was of circumstantial origin. Bedside BNP assays were conducted in parallel with the usual clinical management. For each patient, three diagnoses (cardiac, respiratory or uncertain) were established: firstly, according to the usual clinical criteria (diagnosis 1); secondly (diagnosis 2) according to the result of BNP measurement. When the diagnoses 1 and 2 were not in agreement, patients were entered into a category labeled "diagnostic correction". RESULTS: Fifty-two patients were included in the study. Twenty-one patients had clinically obvious LVF (diagnosis 1' = cardiac). For seven other patients, the clinical variables suggested a respiratory cause (diagnosis 1 = respiratory). For 24 patients dyspnoea was due to a non-identified cause (diagnosis 1 = uncertain). BNP levels were measured in 51 out of 52 patients (one failure). Only nine patients had a BNP level lower than the threshold value of 100 pg ml(-1). In 71% the diagnosis 1 was corrected after BNP estimation. Only two of 27 patients with marked bronchospasm had a BNP level lower than 100 pg ml(-1). CONCLUSION: Estimation of BNP is both feasible and easy in prehospital care, and can confirm the cardiac origins of atypical acute dyspnoea. In elderly patients LVF appears to be clinically underestimated. BNP assay may produce improvements in prehospital management of patients with dyspnoea.

Acute Disease↗

Hypertonic saline during CPR: Feasibility and safety of a new protocol of fluid management during resuscitation.

BACKGROUND AND PURPOSE: In experimental studies infusion of hypertonic saline during cardiopulmonary resuscitation (CPR) increased resuscitation success rate and improved myocardial and cerebral reperfusion during CPR. We tested the feasibility and the safety of this new therapeutic measure in a randomised, preclinical pilot study. METHODS: The study was performed in the EMS system of Bonn after approval of the local ethical committee. Study inclusion criteria were out-of-hospital cardiac arrest (CA) of non-traumatic origin, age > or =18 years, application of adrenaline (epinephrine) during CPR, duration of CA < or = 15 min, and estimated body weight < or = 125 kg. Patients randomly received 2 ml/kg/10 min HHS (7.2% NaCl with 6% hydroxy ethyl starch 200,000/0.5 [HES]) or HES alone. Haemoglobin, blood gases, plasma sodium and potassium concentrations were measured before and 10 min after infusion, and after admission to hospital. Feasibility and safety of the new fluid management was evaluated by looking for side effects and determination of resuscitation success and admission rates. RESULTS: Sixty-six patients were included. After infusion of HHS, plasma sodium concentration increased to 168+/-29 mmol/l at 10 min after application but already decreased to near normal (147+/-5.5 mmol/l) at admission to hospital. Patients receiving HHS showed a trend to higher resuscitation success and hospital admission rates (ROSC: HHS 66.7%, HES 51.5%, p = 0.21; admission: HHS 57.6%, HES 39.4%, p = 0.14). The benefit of HHS was more pronounced if duration of untreated CA was >6 min or if initial rhythm was asystole or pulseless electrical activity (PEA). Negative side-effects were not observed after HHS. CONCLUSIONS: HHS after CA is feasible and safe and might improve short term survival after CPR. However, whether giving HHS could be a useful measure to increase resuscitation success after out-of-hospital CA requires a larger preclinical trial.

Aged↗

Laparoscopic transabdominal pyeloplasty in children is feasible irrespective of age.

PURPOSE: We assessed the feasibility of laparoscopic transabdominal dismembered pyeloplasty in 46 infants and children with regard to patient age. MATERIALS AND METHODS: A total of 46 consecutive infants and children (31 male and 15 female) underwent laparoscopic transabdominal dismembered pyeloplasty using a 3 to 4-trocar technique. All patients had confirmed unilateral deterioration of renal function on isotope renography. The 46 patients were divided into 3 age groups--1 to 12 months (group 1, 14 patients), 1 to 7 years (group 2, 15 patients) and 7 to 18 years (group 3, 17 patients). Followup included clinical and ultrasound assessment, and isotope renography at 3 months. RESULTS: Laparoscopic pyeloplasty was feasible in 44 of 46 patients (96%). Mean operative time was 175 minutes (range 120 to 270). The operation was converted due to impracticality of stenting the PUJ in 1 patient, and due to bleeding in 1. Mean operative time in 44 successful laparoscopic procedures was not significantly different among the 3 age groups (171 minutes in group 1, 169 minutes in group 2 and 173 minutes in group 3). Two patients required operative intervention for PUJ leakage, and 1 underwent percutaneous nephrostomy with a further uneventful course. Mean followup was 29 months (range 3 to 86). A total of 44 patients (96%) were asymptomatic and had improved PUJ drainage on isotope renography. Two patients underwent redo pyeloplasty due to recurrent hydronephrosis at 1 month and 2 years. CONCLUSIONS: Laparoscopic transabdominal dismembered pyeloplasty is effective and safe in infants and children. The feasibility is also excellent in patients younger than 1 year. The transabdominal approach revealed good exposition without a disadvantage for the patient.

Abdomen↗

A feasibility study of chiropractic spinal manipulation versus sham spinal manipulation for chronic otitis media with effusion in children.

BACKGROUND: Pediatric otitis media with effusion is a common and costly condition. Although chiropractors have anecdotally claimed success in treating otitis media, there is little research to support their claims. OBJECTIVE: A pilot study was undertaken for the purpose of assessing the feasibility of conducting a full-scale randomized clinical trial investigating the efficacy of chiropractic spinal manipulative therapy (SMT) for children with chronic otitis media with effusion. METHODS: This study was a prospective, parallel-group, observer-blinded, randomized feasibility study. Twenty-two patients, ages 6 months to 6 years, received either active chiropractic SMT or placebo chiropractic SMT. Otoscopy and tympanometry were used to create a middle ear status profile, and daily diaries were collected. RESULTS: Five newspaper advertisements over 6 months generated 105 responses. Twenty patients subsequently qualified and were randomized into the study. Collection of tympanometric and otoscopic data proved to be challenging. Compliance with the treatment and evaluation protocols and daily diaries was excellent. There were no reports of serious side effects as a result of either the active or placebo chiropractic treatments. CONCLUSION: Recruitment for a randomized controlled trial is feasible and could be enhanced by medical collaboration. Patients and parents are able and willing to participate in a study comparing active SMT and placebo SMT. Parents were extremely compliant with the daily diaries, suggesting that similar quality-of-life and functional status measures can be successfully used in a larger trial. We found the objective outcomes assessment involving tympanometry and otoscopy extremely challenging and should be performed by experienced examiners in future studies.

Child↗

Accuracy and feasibility of daily infrared tympanic membrane temperature measurements in the identification of fever in children.

BACKGROUND: Fever is an important physical sign in infectious diseases in childhood. Daily assessment of fever may be used to monitor the occurrence of infections for research purposes. The infrared tympanic membrane thermometer (ITT) seems ideal for measuring central body temperature. Its accuracy, however, is still debated, and the feasibility of daily temperature measurements with an ITT has not been described. OBJECTIVE: To determine the accuracy and feasibility of daily infrared tympanic membrane temperature measurements at home. METHODS: Tympanic membrane temperature was measured by the Braun Pro 3000, rectal temperature by the Omron MC 63. To establish the accuracy of the ITT, rectal and tympanic membrane temperature measurements were performed in 41 children, aged 2-10 years. To establish the feasibility of daily infrared tympanic temperature measurements at home, parents of 21 children performed daily measurements for 2 weeks. RESULTS: With fever defined as a body temperature of > or =38.0 degrees C, sensitivity was 93.3%, specificity 92%, positive predictive value 87.5%, negative predictive value 95.8%, and the concordance rate 92.5%. Most of the parents found the instructions for the use of the ITT clear (93%) and the ITT easy to use (86%). During the test period of 2 weeks the technique of the tympanic membrane temperature measurements remained adequate in 93% of the parents. CONCLUSION: The tympanic membrane temperature measured by the Braun Pro 3000 accurately reflects rectal temperature, validly assesses the presence of fever in children, and is easy to use. The Braun ITT therefore is an adequate tool to assess fever and may be used both in a clinical setting and for research purposes.

Body Temperature↗

Feasibility, safety, cost-effectiveness and 1 year follow-up of coronary stenting without predilation: a matched comparison with the standard approach.

BACKGROUND: We evaluated the feasibility, safety, procedural cost-effectiveness, radiation dose and time and 1-year target vessel revascularization rate of direct unprotected mounted stenting without previous balloon dilatation (DS) in native coronary artery lesions. METHODS: DS was attempted in 119 patients; 39 had a recent myocardial infarction, 62 had unstable angina, and 18 had stable angina. The clinical follow-up was obtained at 14+/-5 months (range 6 to 24 months). These results were compared with those for a consecutive group of 160 patients matched for type and length of lesions and who had a stent only if the post-balloon residual stenosis was >30%. RESULTS: The feasibility of DS was 112/119 (94%). The number of inflations, the length of the stent/length of the lesion ratio, the time and the dose of radiation were dramatically lower in the DS group (P<0.001). DS conferred a slight reduction in procedure-related cost [$820+/-157 for DS vs. 894+/-427 for standard dilatation (SD) per patient]. The 1-year target vessel revascularization rate was similar in both groups [nine (8%) for DS vs. 17 (11%) patients for SD, ns]. CONCLUSIONS: DS is feasible and safe in selected coronary lesions. This method provides a low rate of repeat revascularization and reduces the time and the dose of radiation compared with the standard approach.

Aged↗