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Pilot Study (pilot + study)
Kinds of Pilot Study Terms modified by Pilot Study Selected AbstractsDIAGNOSIS OF COLONIC ADENOMAS BY NEW AUTOFLUORESCENCE IMAGING SYSTEM: A PILOT STUDYDIGESTIVE ENDOSCOPY, Issue 2007Noriya Uedo Detection and removal of adenoma by colonoscopy is an important means of preventing cancer. Autofluorescence endoscopy can visualize flat or isochromatic tumor that was not detectable by white light endoscopy by the difference in tissue fluorescence properties. Recently, a new autofluorescence imaging system (AFI, Olympus Medical Systems) using a combination of autofluorescence and reflection imaging has been developed. The purpose of the present paper was to investigate its feasibility in detection of colonic adenoma in a clinical setting. A total of 64 patients were randomly assigned to AFI or white light groups, and the distal sigmoid colon and the rectum was observed under autofluorescence or white light followed by the other mode of observation by a different endoscopist. The diagnostic ability of each method for detection of neoplasms was compared in relation to the histology as a reference standard. Sensitivity and specificity of AFI for detection of neoplastic polyps was 84% and 60%, respectively, and were similar to those of white light colonoscopy: 90% and 64%. Conventional colonoscopy overlooked more flat lesions including one adenocarcinoma. AFI has the potential to detect more flat lesions but efficacy was unable to be demonstrated in the restricted population. Further investigations are needed to determine optimum usage. [source] EFFECTS OF ANTIOXIDANT SUPPLEMENTS COMBINED WITH RESISTANCE EXERCISE ON GAINS IN FAT-FREE MASS IN HEALTHY ELDERLY SUBJECTS: A PILOT STUDYJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 9 2008Mélissa Labonté Dtp No abstract is available for this article. [source] A PILOT STUDY OF PREOPERATIVE AND POSTOPERATIVE CHEMOTHERAPY IN PATIENTS WITH OPERABLE GASTRIC CANCER: AUSTRALASIAN GASTROINTESTINAL TRIALS GROUP STUDY 9601ANZ JOURNAL OF SURGERY, Issue 4 2007Michael Findlay Background: With poor cure rates in gastric cancer using surgery alone, the safety, efficacy and feasibility of preoperative and postoperative chemotherapy was investigated. Methods: Patients with advanced but operable gastric or cardio-oesophageal adenocarcinoma were staged using endoscopy, computed tomography scan and laparoscopy. If considered potentially resectable, they received chemotherapy (epirubicin, cisplatin and 5-fluorouracil) for 9 weeks before and after surgery. Results: Of 59 participants entered, two were found to have metastatic disease and were excluded from the analysis. Of the participants, 10 were women and 47 men; their median age was 58 years (range 27,83 years) and median performance status 0 (range 0,1). Two of the 57 participants commencing chemotherapy did not undergo surgery (one sudden death, one new liver metastases). Grade 3 and 4 preoperative and postoperative toxicity rates were, respectively, neutropenia 22 and 18%, emesis 12 and 14% and other non-haematological toxicity <10 and <10%. Of the 55 who underwent surgery, 40 had apparently curative resections (clear or positive microscopic margins), 2 died after surgery (anastomotic leak, sepsis) and 16 had postoperative complications. Of these, 27 participants commenced postoperative chemotherapy and 21 completed it. Median progression-free survival and overall survival were 19.6 and 22 months, respectively. Conclusion: Epirubicin, cisplatin and protracted venous infusion of 5-fluorouracil chemotherapy was well-tolerated in the preoperative setting and did not appear to increase complication rates of surgery for advanced and operable stomach cancer. These findings demonstrate the feasibility of this strategy in the Australasian clinical setting and are in keeping with the results of a recently reported randomized trial, which demonstrated a significant survival advantage using this chemotherapy regimen. [source] EFFECTS OF THE NOVEL SYMBIOTIC IMMUBALANCE AS A FOOD SUPPLEMENT IN RELIEVING CLINICAL SYMPTOMS OF JAPNESE CEDAR POLLINOSIS: A PILOT STUDYCLINICAL AND EXPERIMENTAL PHARMACOLOGY AND PHYSIOLOGY, Issue 2007Yukio Otsuka SUMMARY 1Probiotics have been suggested to have potential for treating food allergy in small children. Although oral probiotics have been studied extensively in animals and humans for various allergies, their effects on the prevention and/or treatment of pollinosis have not been adequately investigated. 2The aim of the present study was to examine the effects of the novel symbiotic food supplement ImmuBalance (a koji fungus (Aspergillus oryzae) and lactic acid bacteria (Pediococcus parvulus and Enterococcus faecium) soybean fermentation product; Nichimo Co. Ltd, Tokyo, Japan) on the prevention and treatment of allergic reactions in Japanese cedar pollinosis (JCP) during the pollen season. 3An open-label pilot study on seven individuals with JCP was conducted. Each participant received oral administration of 1.0,2.0 g ImmuBalance daily for 3 months, which contained 1.8 ¥ 1010/g heat-killed lactobacteria. Six participants (four men, two women; 26,55 years of age) completed the 3 months of supplementation. One participant was excluded from the study because the JCP-specific IgE in RAST scores was lower than 2 UA/mL. The clinical severity of JCP in past year for each participant was self-evaluated on a five-point scale from 0 to 4, in accordance with the guidelines of the Nasal Allergy Clinic 2002, Japan. 4Self-evaluated overall average symptom scores (1.7 ± 0.8) in the peak pollen season showed significant improvement compared with the past year (3.5 ± 0.5; P = 0.001). Furthermore, the average scores for sneezing and runny nose in the peak pollen season showed significant improvement compared with the past year. The scores for swelling and colour of the mucosa and snivel in the nasal cavity did not increase significantly in the peak pollen season compared with baseline. 5Our studies suggest that dietary ImmuBalance may be effective in the prevention and treatment of JCP. The underlying mechanisms of action and the possibility of a randomized, placebo-controlled trial are being investigated. [source] Increasing Self-Management Skills in Heart Failure Patients: A Pilot StudyCONGESTIVE HEART FAILURE, Issue 6 2005Kristin J. Flynn PhD Nonadherence to medical treatment among heart failure patients is high and results in frequent exacerbations and premature death. This treatment-only pilot study examined whether a year-long group-based self-management intervention is feasible and improves self-management skills in patients with mild-to-moderate heart failure (ejection fraction ,40% and New York Heart Association functional class I, II, or III). A total of 31 of 100 recruited patients (31%) agreed to participate. Twenty-six (84%) completed the year-long self-management program. Compared with baseline, the intervention was associated with an increase in overall self-efficacy in practicing self-management skills (p<0.001) and in four of five specific self-management skills. Patients and their group leaders also reported an increase in actual use of self-management skills (p<0.001) and in several psychosocial outcomes. The success of this pilot study suggests the need for a randomized clinical trial to test the efficacy of group-based self-management training on medical outcomes. [source] Effect of Orlistat in Obese Patients With Heart Failure: A Pilot StudyCONGESTIVE HEART FAILURE, Issue 3 2005Luís Beck-da-Silva MD Heart failure is the leading cause of hospitalization. Obesity is increasingly common and is a major public health problem. The aim of this study is to assess whether obese patients with heart failure can benefit from losing weight via an orlistat-assisted diet. This randomized clinical trial included obese patients with ejection fractions ,40%. Orlistat and diet counseling were compared with diet counseling alone. Twenty-one consecutive obese patients with heart failure were recruited. Significant improvement in 6-minute walk test (45.8 m; 95% confidence interval, 5.2,86.4 m; p=0.031), functional class (,0.6±0.5, p=0.014), weight loss (,8.55 kg; 95% confidence interval, ,13.0 to ,4.1 kg;p<0.001) and also significant decreases in total cholesterol (p=0.017), low-density lipoprotein cholesterol (p=0.03), and triglycerides (p=0.036) were observed in the orlistat group. Orlistat can promote significant weight loss and symptoms of relief in obese patients with heart failure, as measured by 6-minute walk test and functional capacity. The lipid profile improved. Orlistat was safe and well tolerated. [source] Commentary: From Serendipity to Pilot Study and Then Pivotal Trial: Bimatoprost Topical for Eyelash GrowthDERMATOLOGIC SURGERY, Issue 5 20102Article first published online: 2 APR 2010, JOEL L. COHEN MD Dr. Cohen has been a consultant and clinical trial investigator for Allergan (including related to Latisse). [source] Skin Tightening Effect Using Fractional Laser Treatment: I. A Randomized Half-Side Pilot Study on Faces of Patients with AcneDERMATOLOGIC SURGERY, Issue 1 2010TERUKI DAINICHI MD BACKGROUND Fractional laser resurfacing is a new procedure for skin rejuvenation. OBJECTIVE To assess the skin remodeling effect of fractional laser treatment. METHODS Twelve Asian patients with acne were irradiated using a fractional 1,540-nm erbium glass laser on a random half of the face twice with a 4-week interval. RESULTS The faces were contoured on the treated side of most patients. Statistical analyses of the facial images showed that the skin tightening effect was significant 4 weeks after the first and second irradiation (p<.001 after both treatments). CONCLUSION These results suggest that fractional laser resurfacing is a possible alternative to nonsurgical skin tightening of the face. The authors have indicated no significant interest with commercial supporters. [source] Minimally Ablative Erbium:YAG Laser Resurfacing of Facial Atrophic Acne Scars in Asian Skin: A Pilot StudyDERMATOLOGIC SURGERY, Issue 5 2008YONG-KWANG TAY MD BACKGROUND Atrophic scars are dermal depressions caused by collagen damage most commonly occurring after inflammatory acne vulgaris. There are little published data regarding the effectiveness and safety of minimally invasive lasers in the treatment of atrophic acne scars in darker skin types. OBJECTIVE The purpose was to evaluate the efficacy and safety of a low-fluence 2,940-nm erbium:YAG laser in the treatment of atrophic acne scars in Asian patients. MATERIALS AND METHODS Nine patients aged 19 to 45 years with mild to moderate atrophic facial scars and Skin Types IV and V were treated with topical anesthesia and one to two passes with an erbium:YAG laser two times at 1-month intervals. Treatment parameters were 6-mm spot size, fluence of 400 mJ, pulse duration of 300 ,s, and repetition rate of 2 Hz. RESULTS At 2 months after the last treatment, mild to moderate clinical improvement was noted in all patients compared to baseline. Treatment was well tolerated. Side effects consisted of posttreatment erythema, peeling, and crusting, which resolved within 1 to 2 weeks. There was no postinflammatory hyper- or hypopigmentation, blistering, or hypertrophic scarring. CONCLUSION Low-fluence erbium:YAG facial resurfacing was effective and safe in patients with mild to moderately severe atrophic acne scarring. [source] Treatment of Inflammatory Facial Acne Vulgaris with Intense Pulsed Light and Short Contact of Topical 5-Aminolevulinic Acid: A Pilot StudyDERMATOLOGIC SURGERY, Issue 8 2006JINDA ROJANAMATIN MD BACKGROUND Photodynamic therapy (PDT) with topical 5-aminolevulinic acid (ALA) and red light (550,700 nm) has been introduced for effective treatment of facial acne. Untoward side effects are common, however. OBJECTIVE To evaluate the efficacy and safety of the short contact of topical ALA and intense pulsed light (IPL) in treatment of inflammatory facial acne. METHODS Fourteen patients with inflammatory facial acne were treated with IPL on the left side and combination of IPL and topical ALA on the right side at 3- to 4-week intervals for three sessions. Clinical photographs and lesion counts were obtained for evaluation. RESULTS All patients revealed a reduction in number of acne lesions on both sides. On the ALA-pretreated side, lesion counts decreased 87.7% at 12 weeks after the last treatment (p<.01). Meanwhile, lesion counts on the nonpretreated side decreased 66.8% (p<.01). In addition, a number of lesion counts on the ALA-pretreated side decreased. Mild edema and minimal crust developed on the combined-treatment side. CONCLUSION Short contact of topical ALA and IPL or IPL alone showed some beneficial effect in treatment of inflammatory facial acne; however, degree of improvement was better and remained longer with the combined regimen. Side effects were mild and reversible. [source] The Treatment of Melasma with Fractional Photothermolysis: A Pilot StudyDERMATOLOGIC SURGERY, Issue 12 2005Cameron K. Rokhsar MD Background. Melasma is a common pigmentary disorder that remains resistant to available therapies. Facial resurfacing with the pulsed CO2 laser has been reported successful but requires significant downtime, and there is a risk of adverse sequelae. Objective. To determine if melasma will respond to a new treatment paradigm, fractional resurfacing. Methods. Ten female patients (Fitzpatrick skin types III,V) who were unresponsive to previous treatment were treated at 1- to 2-week intervals with the Fraxel laser (Reliant Technologies, Palo Alto, CA, USA). Wavelengths of 1,535 and 1,550 nm were both used, and 6 to 12 mJ per microthermal zone with 2,000 to 3,500 mtz/cm2 were the treatment parameters. Four to six treatment sessions were performed. Responses were evaluated according to the percentage of lightening of original pigmentation. Two physicians evaluated the photographs, and each patient evaluated her own response. Results. The physician evaluation was that 60% of patients achieved 75 to 100% clearing and 30% had less than 25% improvement. The patients' evaluations agreed, except for one patient, who graded herself as 50 to 75% improved as opposed to the physician grading of over 75%. There was one patient with postinflammatory hyperpigmentation and no patient with hypopigmentation. No downtime was necessary for wound healing. Conclusions. Fractional resurfacing affords a new treatment algorithm for the treatment of melasma that combines decreased risk and downtime with significant efficacy. This treatment modality deserves further exploration to maximize benefits. RELIANT technologies LOANED THE FRAXEL LASER FOR THE STUDY. RICHARD E. FITZPATRICK, MD, IS A PAID CONSULTANT FOR RELIANT AND A STOCKHOLDER. [source] A Comparison of Two Botulinum Type A Toxin Preparations for the Treatment of Glabellar Lines: Double-Blind, Randomized, Pilot StudyDERMATOLOGIC SURGERY, Issue 12 2005Philippa L. Lowe MB ChB Background. Botulinum toxins have been proven effective for reducing facial lines. There are two commercial types of botulinum toxin type A available in many countries but no published comparison studies. Objective. To compare the efficacy and tolerability of Botox Cosmetic and Dysport 50 U in the treatment of glabellar lines (using 20 U of Botox Cosmetic, which is the dose approved by the US Food and Drug Administration for the treatment of glabellar lines, and 50 U of Dysport, which has been reported to be the optimal dose for this formulation). Study Design. Parallel-group double-blind pilot study. Evaluation by observing physician, photographic, and patient evaluations. Conclusion. Botox 20 U provided better and more prolonged efficacy than Dysport 50 U in the treatment of glabellar lines. NICHOLAS LOWE, MD, FRCP, AND RICKIE PATNAIK, MD, HAVE RECEIVED RESEARCH GRANTS FROM ALLERGAN INC. NICHOLAS LOWE OWNS STOCK IN ALLERGAN INC AND HAS RECEIVED CONSULTING PAYMENTS AND EDUCATIONAL GRANTS FROM ALLERGAN INC. THIS STUDY WAS FUNDED BY A GRANT FROM ALLERGAN INC. [source] Double-Blind, Randomized, Placebo-Controlled Pilot Study of the Safety and Efficacy of Myobloc (Botulinum Toxin Type B) for the Treatment of Palmar HyperhidrosisDERMATOLOGIC SURGERY, Issue 3 2005Leslie Baumann MD Background Palmar hyperhidrosis is a problem of unknown etiology that affects patients both socially and professionally. Botulinum toxin type B (Myobloc), approved by the Food and Drug Administration for use in the treatment of cervical dystonia in the United States in December 2000, has subsequently been used effectively in an off-label indication to treat hyperhidrosis. There are sparse data, however, in the literature evaluating the safety and efficacy of BTX-B for the treatment of palmar hyperhidrosis. Objective We evaluated the safety and efficacy of Myobloc in the treatment of bilateral palmar hyperhidrosis. This was a double-blind, randomized, placebo-controlled study to report on the safety and efficacy of Myobloc. Methods Twenty participants (10 men, 10 women) diagnosed with palmar hyperhidrosis were injected with either Myobloc (5,000 U per palm) or a 1.0 mL vehicle (100 mM NaCl, 10 mM succinate, and 0.5 mg/mL human albumin) into bilateral palms (15 Myobloc, 5 placebo). The participants were followed until sweating returned to baseline levels. The main outcome measures were safety, efficacy versus placebo, and duration of effect. Results A significant difference was found in treatment response at day 30, as determined by participant assessments, between 15 participants injected with Myobloc and 3 participants injected with placebo. The duration of action, calculated in the 17 participants who received Myobloc injections and completed the study, ranged from 2.3 to 4.9 months, with a mean duration of 3.8 months. The single most reported adverse event was dry mouth or throat, which was reported by 18 of 20 participants. The adverse event profile also included indigestion or heartburn (60%), excessively dry hands (60%), muscle weakness (60%), and decreased grip strength (50%). Conclusion Myobloc proved to be efficacious for the treatment of palmar hyperhidrosis. Myobloc had a rapid onset, with most participants responding within 1 week. The duration of action ranged from 2.3 to 4.9 months, with a mean of 3.8 months. The adverse event profile included dry mouth, indigestion or heartburn, excessively dry hands, muscle weakness, and decreased grip strength. MYOBLOC WAS PROVIDED FOR THIS STUDY BY ELAN PHARMACEUTICALS. [source] Combined Excimer Laser and Topical Tacrolimus for the Treatment of Vitiligo: A Pilot StudyDERMATOLOGIC SURGERY, Issue 2 2004Adam Z. Kawalek BA Background. Vitiligo is an acquired skin disorder that is characterized by well-defined, often symmetric white patches. Although current therapeutic modalities are directed toward increasing melanocyte melanin production, few treatment modalities address the immunologic nature of the disease. Objective. To determine whether excimer laser, a known therapeutic modality, in combination with tacrolimus, a topical immunomodulator, accelerate response time and/or improve the degree of response in patients with this disorder. Methods. Eight subjects diagnosed with vitiligo were recruited to participate in this institutional review board,approved double-blind, placebo-controlled study. Twenty-four symmetric vitiliginous patches (elbows, knees) from eight subjects received excimer laser treatment three times per week for 24 treatments or 10 weeks. Additionally, topical tacrolimus 0.1% ointment (Protopic) and placebo (Aquaphor) were applied to randomized patches (left or right) twice daily throughout the length of the trial. Vitiliginous patches were monitored with photographs at baseline, every 2 weeks, and 6 months after treatment. Biopsies were performed on subjects with significant results. Results. Twenty vitiliginous patches from six subjects qualified for evaluation. Fifty percent of patches treated with combination excimer laser and tacrolimus achieved a successful response (75% repigmentation) compared with 20% for the placebo group. Subjects who responded successfully repigmented faster (19%) with combination therapy compared with excimer laser alone. Additionally, three subjects experienced transient hyperpigmentation in lesions treated with combination therapy. Conclusion. Combining topical immunomodulators with known phototherapeutic modalities may represent a key advancement in the treatment of disease. [source] Cold Air Analgesia in Photodynamic Therapy of Basal Cell Carcinomas and Bowen's Disease: An Effective Addition to Treatment: A Pilot StudyDERMATOLOGIC SURGERY, Issue 1 2004FACD, John Pagliaro MB Background. There is considerable interpatient variability in pain tolerance during and after treatment of skin cancer with photodynamic therapy (PDT). Additionally, erythema and edema are common, with mild crusting and healing over 1 to 2 weeks. Objective. To determine whether concurrent cold air analgesia improves the tolerability of PDT. Method. Twenty-six patients with two similar superficial skin cancers were treated with PDT. One lesion was treated with cold air analgesia and the other without. Patients rated their pain during treatment using the Wong Baker Faces Pain Scale and detailed duration of posttreatment pain. At week 2, the inflammatory response was assessed. Result. A statistically significant difference in the analgesia group was shown with respect to the mean duration of pain and the level of erythema after the first treatment as well as pain scores during the second treatment. Conclusion. Patient acceptance of PDT for treatment of nonmelanoma skin cancer is improved with lessened morbidity assessed with concurrent use of cold air analgesia to the treatment field. [source] Effect of Wax Epilation Before Hair Removal With a Long-Pulsed Alexandrite Laser: A Pilot StudyDERMATOLOGIC SURGERY, Issue 2 2003Michael S. Lehrer MD Background. Recent reports indicate that laser hair removal is most effective on anagen hairs. However, no published trials have examined laser epilation after hair cycle synchronization. Objective. To evaluate the potential for enhanced laser hair removal after the induction of telogen hairs into anagen by wax epilation. Methods. We identified four 2.5-cm square areas with equivalent hair length and density on the backs of 13 dark-haired white men. To induce typically telogen hairs into anagen, two areas on each patient were wax epilated. Two weeks later, one waxed area and one unwaxed area were treated with a long-pulsed alexandrite laser. One month after laser treatment, a subjective comparison was made based on hair density, length, and thickness. Results. In 12 of 13 patients, lasered areas that had been pretreated with wax epilation were clearer of hair as compared with areas that had been pretreated by shaving (P=0.0034). No significant difference was noted between waxed and unwaxed control areas that had not been laser treated (P=1.0). Conclusion. Wax epilation 2 weeks before laser hair removal improves cosmetic outcomes at 1 month. This effect may be secondary to the recruitment and heightened sensitivity of early anagen hairs. [source] The Use of Microdermabrasion for Acne: A Pilot StudyDERMATOLOGIC SURGERY, Issue 4 2001Jenifer R. Lloyd DO Background. Microdermabrasion is a superficial peeling modality that has become quite popular with our patients and the media. Objective. To evaluate the use of microdermabrasion in patients with acne. Methods. Twenty-five patients with grade II,III acne were enrolled into this pilot study. All patients were under dermatologic care and were maintained on their acne medications throughout the study. Patients received eight microdermabrasion treatments at weekly intervals. The results were documented with before and after photographs and evaluated for clinical improvement. Results. Twenty-four patients completed the study with 38% (9/24) having excellent results, 34% (8/24) with good results, 17% (4/24) with fair results, and 12% (3/24) with poor results. Ninety-six percent (23/24) of patients were pleased with their peel results and would recommend this procedure to others. Conclusion. The use of microdermabrasion in this pilot study appeared to produce a positive effect on the improvement of acne. [source] A Pilot Study of the Clinical Impact of Hand-Carried Cardiac Ultrasound in the Medical ClinicECHOCARDIOGRAPHY, Issue 6 2006Lori B. Croft M.D. Background: Small, hand-carried ultrasound devices have become widely available, making point-of-care echocardiograms (echos) accessible to all medical personnel as a means to augment and improve the increasingly inefficient physical examination. This study was designed to determine the clinical utility of hand-carried echo by medical residents in clinical decision making. Methods: Nine residents underwent brief, practical echo training to perform and interpret a limited hand-carried echo as an integral component of their office examination. The residents' hand-carried echo consisting of four basic views to define left ventricular (LV) function and wall thickness, valvular disease, and any pericardial effusions was compared to one performed by a level III echocardiographer. Results: Seventy-two consecutive medical clinic patients were enrolled with an average image acquisition time of 4.45 minutes. Residents obtained diagnostic images in 94% of the cases and interpreted them correctly 93% of the time. They correctly identified 92% of the major echo findings and 78% of the minor findings. Their diagnosis of LV dysfunction, valvular disease, and LV hypertrophy improved by 19%, 39%, and 14% with hand-carried echo compared to history and physical alone. Management decisions were reinforced in 76% and changed in 40% of patients with the use of hand-carried echo. Conclusion: This study demonstrates that it is possible to train medical residents to perform an effective and reasonably accurate hand-carried echo during their physical examination, which can impact clinical management. [source] Emergency Medicine Crisis Resource Management (EMCRM): Pilot Study of a Simulation-based Crisis Management Course for Emergency MedicineACADEMIC EMERGENCY MEDICINE, Issue 4 2003Martin Reznek MD Objectives: To determine participant perceptions of Emergency Medicine Crisis Resource Management (EMCRM), a simulation-based crisis management course for emergency medicine. Methods: EMCRM was created using Anesthesia Crisis Resource Management (ACRM) as a template. Thirteen residents participated in one of three pilot courses of EMCRM; following a didactic session on principles of human error and crisis management, the residents participated in simulated emergency department crisis scenarios and instructor-facilitated debriefing. The crisis simulations involved a computer-enhanced mannequin simulator and standardized patients. After finishing the course, study subjects completed a horizontal numerical scale survey (1 = worst rating to 5 = best rating) of their perceptions of EMCRM. Descriptive statistics were calculated to evaluate the data. Results: The study subjects found EMCRM to be enjoyable (4.9 ± 0.3) (mean ± SD) and reported that the knowledge gained from the course would be helpful in their practices (4.5 ± 0.6). The subjects believed that the simulation environment prompted realistic responses (4.6 ± 0.8) and that the scenarios were highly believable (4.8 ± 0.4). The participants reported that EMCRM was best suited for residents (4.9 ± 0.3) but could also benefit students and attending physicians. The subjects believed that the course should be repeated every 8.2 ± 3.3 months. Conclusions: The EMCRM participants rated the course very favorably and believed that the knowledge gained would be beneficial in their practices. The extremely positive response to EMCRM found in this pilot study suggests that this training modality may be valuable in training emergency medicine residents. [source] A Pilot Study of an Intervention for Breast Cancer Survivors and Their SpousesFAMILY PROCESS, Issue 1 2004Cleveland G. Shields Ph.D. Recent studies have shown that interventions that increase breast cancer patients' communication with family members lead to reduced patient distress. In this article, we report on a treatment development and pilot study of an intervention for couples coping with breast cancer. In phase 1 of this study, 10 couples participated in two focus groups that generated ideas and themes for the intervention. In phase 2, we developed and pilot tested our intervention with 48 couples: 12 in a 2-session format, 21 in a 1-session format, and 15 in a non-experimental control group. Our response rate shows that breast cancer patients and spouses were willing to participate and that treatment providers were willing to refer patients and their spouses. The 2-session format showed the most promise for producing positive change in mental health functioning and cancer-related stress. [source] A Double-Blind Comparison of OnabotulinumtoxinA (BOTOX®) and Topiramate (TOPAMAX®) for the Prophylactic Treatment of Chronic Migraine: A Pilot StudyHEADACHE, Issue 10 2009Ninan T. Mathew MD Background., There is a need for effective prophylactic therapy for chronic migraine (CM) that has minimal side effects. Objective., To compare the efficacy and safety of onabotulinumtoxinA (BOTOX®, Allergan, Inc., Irvine, CA) and topiramate (TOPAMAX®, Ortho-McNeil, Titusville, NJ) prophylactic treatment in patients with CM. Methods., In this single-center, double-blind trial, patients with CM received either onabotulinumtoxinA, maximum 200 units (U) at baseline and month 3 (100 U fixed-site and 100 U follow-the-pain), plus an oral placebo, or topiramate, 4-week titration to 100 mg/day with option for additional 4-week titration to 200 mg/day, plus placebo saline injections. OnabotulinumtoxinA or placebo saline injection was administered at baseline and month 3 only, while topiramate oral treatment or oral placebo was continued through the end of the study. The primary endpoint was treatment responder rate assessed using Physician Global Assessment 9-point scale (+4 = clearance of signs and symptoms and ,4 = very marked worsening [about 100% worse]). Secondary endpoints included the change from baseline in the number of headache (HA)/migraine days per month (HA diary), and HA disability measured using Headache Impact Test (HIT-6), HA diary, Migraine Disability Assessment (MIDAS) questionnaire, and Migraine Impact Questionnaire (MIQ). The overall study duration was approximately 10.5 months, which included a 4-week screening period and a 2-week optional final safety visit. Follow-up visits for assessments occurred at months 1, 3, 6, and 9. Adverse events (AEs) were documented. Results., Of 60 patients randomized to treatment (mean age, 36.8 ± 10.3 years; 90% female), 36 completed the study at the end of the 9 months of active treatment (onabotulinumtoxinA, 19/30 [63.3%]; topiramate, 17/30 [56.7%]). In the topiramate group, 7/29 (24.1%) discontinued study because of treatment-related AEs vs 2/26 (7.7%) in the onabotulinumtoxinA group. Between 68% and 83% of patients for both onabotulinumtoxinA and topiramate groups reported at least a slight (25%) improvement in migraine; response to treatment was assessed using Physician Global Assessment at months 1, 3, 6, and 9. Most patients in both groups reported moderate to marked improvements at all time points. No significant between-group differences were observed, except for marked improvement at month 9 (onabotulinumtoxinA, 27.3% vs topiramate, 60.9%, P = .0234, chi-square). In both groups, HA/migraine days decreased and MIDAS and HIT-6 scores improved. Patient-reported quality of life measures assessed using MIQ after treatment with onabotulinumtoxinA paralleled those seen after treatment with topiramate in most respects. At month 9, 40.9% and 42.9% of patients in the onabotulinumtoxinA and topiramate groups, respectively, reported ,50% reduction in HA/migraine days. Forty-one treatment-related AEs were reported in 18 onabotulinumtoxinA-treated patients vs 87 in 25 topiramate-treated patients, and 2.7% of patients in the onabotulinumtoxinA group and 24.1% of patients in the topiramate group reported AEs that required permanent discontinuation of study treatment. Conclusions., OnabotulinumtoxinA and topiramate demonstrated similar efficacy in the prophylactic treatment of CM. Patients receiving onabotulinumtoxinA had fewer AEs and discontinuations. [source] Botulinum Toxin Type-A (BOTOX®) in the Treatment of Occipital Neuralgia: A Pilot StudyHEADACHE, Issue 10 2008Martin Taylor DO Objective., To determine the efficacy of occipital nerve blocks using reconstituted botulinum toxin type-A (BTX-A) in providing significant and prolonged pain relief in chronic occipital neuralgia. Background., Occipital neuralgia is a unilateral or bilateral radiating pain with paresthesias commonly manifesting as paroxysmal episodes and involving the occipital and parietal regions. Common causes of occipital neuralgia include irritation or injury to the divisions of the occipital nerve, myofascial spasm, and focal entrapment of the occipital nerve. Treatment options include medication therapy, occipital nerve blocks, and surgical techniques. BTX-A, which has shown promise in relief of other headache types, may prove a viable therapeutic option for occipital neuralgia pain. Methods., Botulinum toxin type-A (reconstituted in 3 cc of saline) was injected into regions traversed by the greater and lesser occipital nerve in 6 subjects diagnosed with occipital neuralgia. Subjects were instructed to report their daily pain level (on a visual analog pain scale), their ability to perform daily activities (on several quality of life instruments) and their daily pain medication usage (based on a self-reported log), 2 weeks prior to the injection therapy and 12 weeks following injection therapy. Data were analyzed for significant variation from baseline values. Results., The dull/aching and pin/needles types of pain reported by the subjects did not show a statistically significant improvement during the trial period. The sharp/shooting type of pain, however, showed improvement during most of the trial period except weeks 3-4 and 5-6. The quality of life measures exhibited some improvement. The headache-specific quality of life measure showed significant improvement by 6 weeks which continued through week 12. The general health- and depression-related measures showed no statistical improvement. No significant reduction in pain medication usage was demonstrated. Conclusions., Our results indicate that BTX-A improved the sharp/shooting type of pain most commonly known to be associated with occipital neuralgia. Additionally, the quality of life measures assessing burden and long-term impact of the headaches, further corroborated improvement seen in daily head pain. [source] Use of the Migraine Disability Assessment Questionnaire in Children and Adolescents With Headache: An Italian Pilot StudyHEADACHE, Issue 7 2003D. D'Amico MD Objectives.,To determine the suitability of the Migraine Disability Assessment (MIDAS) Questionnaire for assessing disability in children and adolescents with headache and to obtain preliminary information about disability in different primary headaches. Background.,During the last decade, researchers have begun to employ standardized methodologies to investigate the global impact of primary headaches. Disease-specific instruments have been developed to measure headache-related disability. The MIDAS Questionnaire, which is the most extensively studied of these instruments, was designed to assess the overall impact of headaches over the 3 months before compilation. The MIDAS Questionnaire is an optimal tool to assess headache-related disability in adults. Methods.,Ninety-five patients aged 7 to 17 years with tension-type headache, migraine, or both completed the validated Italian form of the MIDAS questionnaire on 2 occasions. Test-retest reliability was assessed by the Spearman rank correlation test. The Cronbach , assessed internal consistency. The patients answered questions about the adequacy of the questionnaire. Results.,The Cronbach , was .8. Correlation coefficients were generally high for the overall MIDAS score and for the items investigating disability in school and in family/leisure activities; they were lower for the items about housework. Most patients thought that the MIDAS Questionnaire was useful (98.9%) and that it captured the impact of their headaches (58.9%); 41% thought that questions about disability in housework were useless, 44.2% suggested adding questions regarding inability to do homework. All primary headaches had a considerable impact on daily activities, but patients with migraine tended to have lower headache frequencies and lower total disability time; those with tension-type headache suffered more days in which activities, although performed, were substantially impaired. Conclusions.,The MIDAS Questionnaire is useful for assessing disability in children and adolescents with different primary headaches. Minimal changes in the phrasing and content of the items would be sufficient to render the MIDAS specific for the younger population with headache. [source] Amitriptyline Treatment in Chronic Drug-Induced Headache: A Double-Blind Comparative Pilot StudyHEADACHE, Issue 2 2001S. Descombes MD Objective.,To assess the effects of amitriptyline and sudden analgesic withdrawal on headache frequency and quality of life in patients suffering from chronic daily headache related to analgesics abuse. Methods.,Seventeen nondepressed patients with chronic drug-induced headache were included in a 9-week, parallel-group, randomized, double-blind, placebo-controlled study. After abrupt analgesic withdrawal, amitriptyline or an active placebo (trihexyphenidyl) was started. The primary efficacy variable was headache frequency recorded on a headache diary in the last 4 weeks of each treatment. The secondary efficacy variable was quality of life (Nottingham Health Profile). Results.,Headache frequency decreased by 45% in the amitriptyline group and by 28% in the trihexyphenidyl group. Amitriptyline enhanced all the dimensions of quality of life and significantly improved emotional reaction and social isolation. Conclusion.,This pilot study suggests a beneficial effect of amitriptyline on headache frequency and quality of life for patients with chronic drug-induced headache. [source] Automated Measurement of Facial Expression in Infant,Mother Interaction: A Pilot StudyINFANCY, Issue 3 2009Daniel S. Messinger Automated facial measurement using computer vision has the potential to objectively document continuous changes in behavior. To examine emotional expression and communication, we used automated measurements to quantify smile strength, eye constriction, and mouth opening in two 6-month-old infant-mother dyads who each engaged in a face-to-face interaction. Automated measurements showed high associations with anatomically based manual coding (concurrent validity); measurements of smiling showed high associations with mean ratings of positive emotion made by naive observers (construct validity). For both infants and mothers, smile strength and eye constriction (the Duchenne marker) were correlated over time, creating a continuous index of smile intensity. Infant and mother smile activity exhibited changing (nonstationary) local patterns of association, suggesting the dyadic repair and dissolution of states of affective synchrony. The study provides insights into the potential and limitations of automated measurement of facial action. [source] Determining Critical Incident Nursing Interventions for the Critical Care Setting: A Pilot StudyINTERNATIONAL JOURNAL OF NURSING TERMINOLOGIES AND CLASSIFICATION, Issue 3 2009Elizabeth Wong CRNA PURPOSE., The purpose of this research survey was to determine which Adult Critical Care Core Nursing Interventions (ACCCNIs) in the Nursing Interventions Classification constitutes a critical incident nursing intervention (CINI). A CINI is defined as any indirect or direct care registered nurse (RN)-initiated treatment performed in response to a life-threatening nursing diagnosis. METHODS., A list of ACCCNIs were sent to 50 critical care RNs in two survey rounds. Responses >80% for each ACCCNI was determined to be a CINI. FINDINGS., Forty-one ACCCNIs were determined to be CINIs. CONCLUSIONS., It is recommended that CINIs be included as a separate Nursing Intervention Classification category to reflect current nursing practice. IMPLICATIONS FOR NURSING PRACTICE., CINIs can enhance RN competency, education, and vigilance, thereby preventing or decreasing the number of deaths that occur from critical incidents. [source] Impoverished Children With Asthma: A Pilot Study of Urban Healthcare AccessJOURNAL FOR SPECIALISTS IN PEDIATRIC NURSING, Issue 2 2004Andrea Wallace ND ISSUES AND PURPOSE Using Andersen's Behavioral Model of Health Care Use, this pilot study was conducted to better understand the experiences of children with asthma as they access an urban healthcare system. DESIGN AND METHODS This descriptive study used a convenience sample of 34 families of pediatric asthma patients who participated in semistructured interviews and closed medical record review. RESULTS Only one patient reported having a written exacerbation management plan. Beliefs regarding medication addiction and side effects were frequently reported as barriers to medication adherence, and children seeking asthma care in primary care settings saw many care providers. PRACTICE IMPLICATIONS Exploring how expanded nursing roles can help address both family and system factors serving as barriers to health care ought to be a key priority for nursing. [source] Self-Reported Napping and Duration and Quality of Sleep in the Lifestyle Interventions and Independence for Elders Pilot StudyJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 9 2008Jennifer L. Picarsic MD OBJECTIVES: To determine the prevalence of self-reported napping and its association with subjective nighttime sleep duration and quality, as measured according to sleep-onset latency and sleep efficiency. DESIGN: Cross-sectional study. SETTING: Lifestyle Interventions and Independence for Elders Pilot Study. PARTICIPANTS: Community-dwelling older adults (N=414) aged 70 to 89. MEASUREMENTS: Self-report questionnaire on napping and sleep derived from the Pittsburgh Sleep Quality Index (PSQI) scale. RESULTS: Fifty-four percent of participants reported napping, with mean nap duration of 55.0±41.2 minutes. Nappers were more likely to be male (37.3% vs 23.8%, P=.003) and African American (20.4% vs 14.4%, P=.06) and to have diabetes mellitus (28% vs 14.3%, P=.007) than non-nappers. Nappers and non-nappers had similar nighttime sleep duration and quality, but nappers spent approximately 10% of their 24-hour sleep occupied in napping. In a multivariate model, the odds of napping were higher for subjects with diabetes mellitus (odds ratio (OR)=1.9, 95% confidence interval (CI)=1.2,3.0) and men (OR=1.9, 95% CI=1.2,3.0). In nappers, diabetes mellitus (,=12.3 minutes, P=.005), male sex (,=9.0 minutes, P=.04), higher body mass index (,=0.8 minutes, P=.02), and lower Mini-Mental State Examination score (,=2.2 minutes, P=.03) were independently associated with longer nap duration. CONCLUSION: Napping was a common practice in community-dwelling older adults and did not detract from nighttime sleep duration or quality. Given its high prevalence and association with diabetes mellitus, napping behavior should be assessed as part of sleep behavior in future research and in clinical practice. [source] A Pilot Study of Banxia Houpu Tang, a Traditional Chinese Medicine, for Reducing Pneumonia Risk in Older Adults with DementiaJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 12 2007Koh Iwasaki MD OBJECTIVES: To evaluate whether the traditional Chinese herbal medicine Banxia Houpu Tang (BHT, formula magnolia et pinelliae) prevents aspiration pneumonia and pneumonia-related mortality in elderly people. DESIGN: A prospective, observer-blinded, randomized, controlled trial. SETTING: Two long-term care hospitals for handicapped elderly patients in Japan from March 2005 to February 2006. PARTICIPANTS: One hundred four elderly patients (31 men and 73 women; mean age±standard deviation 83.5±7.8) with dementia and cerebrovascular disease, Alzheimer's disease, or Parkinson's disease. INTERVENTION: Ninety-five participants (mean age 84.0, M:F=28:67) were randomly assigned to the BHT treatment group (n=47) or the control group (n=48) and took BHT or placebo for 12 months. MEASUREMENTS: The occurrence of pneumonia, mortality due to pneumonia, and the daily amount of self-feeding. RESULTS: Complete data were available for analysis on 92 of the 95 subjects randomized. Four patients in the BHT group developed pneumonia, and one of them died as a result. Fourteen patients in the control group developed pneumonia, and six of them died as a result. There was a significant difference between the two groups in pneumonia onset (P=.008), and a tendency toward significance in pneumonia-related mortality (P=.05). The relative risk of pneumonia in the BHT group compared with the control group was 0.51 (95% confidence interval (CI)=0.27,0.84, P=.008) and that of death from pneumonia was 0.41 (95% CI=0.10,1.03, P=.06) according to the Cox proportional hazards model. No adverse events were observed from treatment with BHT. The BHT group was able to maintain self-feeding better than the control group (P=.006). CONCLUSION: Treatment with BHT reduced the risk of pneumonia and pneumonia-related mortality in elderly patients with dementia. [source] A Comparison of Computerized and Pencil-and-Paper Tasks in Assessing Cognitive Function in Community-Dwelling Older People in the Newcastle 85+ Pilot StudyJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 10 2007Joanna Collerton MRCP OBJECTIVES: To compare the acceptability and feasibility of computerized and pencil-and-paper tests of cognitive function in 85-year-old people. DESIGN: Group comparison of participants randomly allocated to pencil-and-paper (Wechsler Adult Intelligence and Memory Scales) or computerized (Cognitive Drug Research) tests of verbal memory and attention. SETTING: The Newcastle 85+ Pilot Study was the precursor to the Newcastle 85+ Study a United Kingdom Medical Research Council/Biotechnology and Biological Sciences Research Council cohort study of health and aging in the oldest-old age group. PARTICIPANTS: Eighty-one community-dwelling individuals aged 85. MEASUREMENTS: Participant and researcher acceptability, completion rates, time taken, validity as cognitive measures, and psychometric utility. RESULTS: Participants randomized to computerized tests were less likely to rate the cognitive function tests as difficult (odds ratio (OR)=0.16, 95% confidence interval (CI)=0.07,0.39), stressful (OR=0.18, 95% CI=0.07,0.45), or unacceptable (OR=0.18, 95% CI=0.08,0.48) than those randomized to pencil-and-paper tests. Researchers were also less likely to rate participants as being distressed in the computer test group (OR=0.19, 95% CI=0.07,0.46). Pencil-and-paper tasks took participants less time to complete (mean±standard deviation 18±4 minutes vs 26±4 minutes) but had fewer participants who could complete all tasks (91% vs 100%). Both types of task were equally good measures of cognitive function. CONCLUSION: Computerized and pencil-and-paper tests are both feasible and useful means of assessing cognitive function in the oldest-old age group. Computerized tests are more acceptable to participants and administrators. [source] | ||||||||||||||||||||||||||||||||||||||||||||||