Science.gov

Sample records for prospective clinical pilot

  1. Clinical and radiographic evaluation of single tantalum dental implants: a prospective pilot clinical study

    PubMed Central

    DE FRANCESCO, M.; GOBBATO, E.A.; NOCE, D.; CAVALLARI, F.; FIORETTI, A.

    2016-01-01

    SUMMARY Objective The aim of this prospective pilot clinical case series report was to evaluate, through a clinical and radiographic analysis, the peri-implant bone resorption of the tantalum dental implants (TMT) (Zimmer TMT, Parsippany, NJ, USA) one year after prosthetic rehabilitation. Methods Twenty tantalum dental implants were placed in both maxillas and mandibles of 20 patients. Patients were asked to attend a radiographic and clinical follow-up and their previous clinical records and X-rays were assessed. Bone levels were calculated by digitally measuring the distance from the implant shoulder to the first bone-to-implant on periapical radiographs taken at surgery and after 6 and 12 months of functioning. The Pearson correlation analysis was performed to assess it there was a correlation between the measurement of the marginal bone loss (MBL). The Anova Test with a post-hoc analysis using Bonferroni’s test was used to compare the three group (0, 6 months and 12 months). Results The mean total MBL for the group 0 months was 0.84 mm (SD 0.21), 6 months was 0.87 mm (SD 0.22) and for 12 months was 0.89 mm (SD 0.23). The values of the Pearson’s coefficients showed that the data measurement were positively correlated. The Anova test showed a statistically significant difference between the groups. Conclusion The statistically significant difference in marginal bone loss can be considered physiological. Within the limits of this study it can be concluded that TMT implants have an excellent bone crest’s stability, however, to have most accurate information, will be necessary extend the sample. PMID:28280531

  2. Clinical correlates and predictors of perceived coercion among psychiatric inpatients: A prospective pilot study.

    PubMed

    Gowda, Guru S; Noorthoorn, Eric O; Kumar, Channaveerachari Naveen; Nanjegowda, Raveesh Bevinahalli; Math, Suresh Bada

    2016-08-01

    The current Mental Health Care Bill (MHCB) -2013 in India advocates least restrictive alternatives (LRA) in psychiatric treatment. However, we have little evidence on patient's perspectives of coercion and LRA. This was a hospital-based prospective pilot study. 170 subjects chosen by computer-generated random number sampling were screened. In 83 eligible subjects, all assessments including coercion assessment were completed within 3 days of admission and in 75 subjects reassessment was done within 3 days of discharge. Perceived coercion as measured by the MacArthur Perceived Coercion Scale (MPCS) decreased significantly from 3.72±1.98 at admission to 1.77±1.8 (<0.001) at discharge. This was accompanied by significant increase in global functioning, insight score (from 1.5±1.0 to 3.8±1.1; p<0.001) and as well as decrease in symptom severity (CGI-S) (from 5.9±1.1 to 1.8±1.9; p<0.001). Coercion is predicted by family type, employment status, socio economic status, severity of illness and level of insight. 87% patients reported that their admission was justified even though many felt coerced during hospital stay. Coercion is a dynamic state and changes with treatment and care. Clinical care may result in an improvement in global functioning, insight as well as in reduction in severity of illness consequently leading to less coercion. During the time of discharge, majority of patients reported that their admission was justified, even though they felt coerced during hospital stay and agreed for treatment against their will within a safe, standardised coercive practice. Copyright © 2016 Elsevier B.V. All rights reserved.

  3. Clinical outcomes and risk factors for perforation in gastric endoscopic submucosal dissection: A prospective pilot study

    PubMed Central

    Watari, Jiro; Tomita, Toshihiko; Toyoshima, Fumihiko; Sakurai, Jun; Kondo, Takashi; Asano, Haruki; Yamasaki, Takahisa; Okugawa, Takuya; Ikehara, Hisatomo; Oshima, Tadayuki; Fukui, Hirokazu; Miwa, Hiroto

    2013-01-01

    AIM: To evaluate clinical outcomes and risk factors for endoscopic perforation during endoscopic submucosal dissection (ESD) in a prospective study. METHODS: We investigated the clinical outcomes and risk factors for the development of perforation in 98 consecutive gastric neoplasms undergoing ESD regarding. Demographic and clinical parameters including patient-, tumor-, and treatment-related factors, clinical parameters, and duration of hospital stay were analyzed for risk factors for perforation. In subgroup analysis, we also compared the clinical outcomes between perforation and “silent” free air without endoscopically visible perforation detected only by computed tomography. RESULTS: Perforation was identified in 8.2% of patients. All patients were managed conservatively by the administration of antibiotics. The mean procedure time was significantly longer in patients with endoscopic perforation than in those without. According to the receiver-operating characteristic analysis, the resulting cutoff value of the procedure time for perforation was 115 min (87.5% sensitivity, 56.7% specificity). Prolonged procedure time (≥ 115 min) was associated with an increased risk of perforation (odds ratio 9.15; 95%CI: 1.08-77.54; P = 0.04). Following ESD, body temperature and C-reactive protein level were significantly higher in patients with perforation than in those without (P = 0.02), whereas there was no difference between these patient groups on the starting day of oral intake or of hospitalization. In subgroup analysis, the post-ESD clinical course was not different between endoscopic perforation and silent free air. CONCLUSION: Only prolonged procedure time (≥ 115 min) was significantly associated with perforation. The clinical outcomes of perforation are favorable and are comparable to those of patients with or without silent free air. PMID:23772265

  4. Clinical outcomes and risk factors for perforation in gastric endoscopic submucosal dissection: A prospective pilot study.

    PubMed

    Watari, Jiro; Tomita, Toshihiko; Toyoshima, Fumihiko; Sakurai, Jun; Kondo, Takashi; Asano, Haruki; Yamasaki, Takahisa; Okugawa, Takuya; Ikehara, Hisatomo; Oshima, Tadayuki; Fukui, Hirokazu; Miwa, Hiroto

    2013-06-16

    To evaluate clinical outcomes and risk factors for endoscopic perforation during endoscopic submucosal dissection (ESD) in a prospective study. We investigated the clinical outcomes and risk factors for the development of perforation in 98 consecutive gastric neoplasms undergoing ESD regarding. Demographic and clinical parameters including patient-, tumor-, and treatment-related factors, clinical parameters, and duration of hospital stay were analyzed for risk factors for perforation. In subgroup analysis, we also compared the clinical outcomes between perforation and "silent" free air without endoscopically visible perforation detected only by computed tomography. Perforation was identified in 8.2% of patients. All patients were managed conservatively by the administration of antibiotics. The mean procedure time was significantly longer in patients with endoscopic perforation than in those without. According to the receiver-operating characteristic analysis, the resulting cutoff value of the procedure time for perforation was 115 min (87.5% sensitivity, 56.7% specificity). Prolonged procedure time (≥ 115 min) was associated with an increased risk of perforation (odds ratio 9.15; 95%CI: 1.08-77.54; P = 0.04). Following ESD, body temperature and C-reactive protein level were significantly higher in patients with perforation than in those without (P = 0.02), whereas there was no difference between these patient groups on the starting day of oral intake or of hospitalization. In subgroup analysis, the post-ESD clinical course was not different between endoscopic perforation and silent free air. Only prolonged procedure time (≥ 115 min) was significantly associated with perforation. The clinical outcomes of perforation are favorable and are comparable to those of patients with or without silent free air.

  5. Vagus Nerve Stimulation to Augment Recovery from Severe Traumatic Brain Injury Impeding Consciousness: A Prospective Pilot Clinical Trial

    PubMed Central

    Shi, Chen; Flanagan, Steven R.; Samadani, Uzma

    2015-01-01

    Objectives Traumatic brain injury has a high morbidity and mortality in both civilian and military populations. Blast and other mechanisms of traumatic brain injury damage the brain by causing neurons to disconnect and atrophy. Such traumatic axonal injury can lead to persistently vegetative and minimally conscious states, for which limited treatment options exist, including physical, occupational, speech and cognitive therapies. More than 60,000 patients have received vagus nerve stimulation for epilepsy and depression. In addition to decreased seizure frequency and severity, patients report enhanced mood, reduced daytime sleepiness independent of seizure control, increased slow wave sleep, and improved cognition, memory, and quality of life. Early stimulation of the vagus nerve accelerates the rate and extent of behavioral and cognitive recovery after fluid percussion brain injury in rats. Methods We recently obtained FDA approval for a pilot prospective randomized crossover trial to demonstrate objective improvement in clinical outcome by placement of a vagus nerve stimulator in patients who are recovering from severe traumatic brain injury. Our hypothesis is that stimulation of the vagus nerve results in increased cerebral blood flow and metabolism in the forebrain, thalamus and reticular formation, which promotes arousal and improved consciousness, thereby improving outcome after traumatic brain injury resulting in minimally conscious or persistent vegetative states. Discussion If this study demonstrates that vagus nerve stimulation can safely and positively impact outcome, then a larger randomized prospective crossover trial will be proposed. PMID:23485054

  6. Efficacy of IP6 + inositol in the treatment of breast cancer patients receiving chemotherapy: prospective, randomized, pilot clinical study

    PubMed Central

    2010-01-01

    Background Prospective, randomized, pilot clinical study was conducted to evaluate the beneficial effects of inositol hexaphosphate (IP6) + Inositol in breast cancer patients treated with adjuvant therapy. Patients and methods Patients with invasive ductal breast cancer where polychemotherapy was indicated were monitored in the period from 2005-2007. Fourteen patients in the same stage of ductal invasive breast cancer were involved in the study, divided in two randomized groups. One group was subjected to take IP6 + Inositol while the other group was taking placebo. In both groups of patients the same laboratory parameters were monitored. When the treatment was finished, all patients have filled questionnaires QLQ C30 and QLQ-BR23 to determine the quality of life. Results Patients receiving chemotherapy, along with IP6 + Inositol did not have cytopenia, drop in leukocyte and platelet counts. Red blood cell counts and tumor markers were unaltered in both groups. However, patients who took IP6 + Inositol had significantly better quality of life (p = 0.05) and functional status (p = 0.0003) and were able to perform their daily activities. Conclusion IP6 + Inositol as an adjunctive therapy is valuable help in ameliorating the side effects and preserving quality of life among the patients treated with chemotherapy. PMID:20152024

  7. Efficacy of IP6 + inositol in the treatment of breast cancer patients receiving chemotherapy: prospective, randomized, pilot clinical study.

    PubMed

    Bacić, Ivan; Druzijanić, Nikica; Karlo, Robert; Skifić, Ivan; Jagić, Stjepan

    2010-02-12

    Prospective, randomized, pilot clinical study was conducted to evaluate the beneficial effects of inositol hexaphosphate (IP6) + Inositol in breast cancer patients treated with adjuvant therapy. Patients with invasive ductal breast cancer where polychemotherapy was indicated were monitored in the period from 2005-2007. Fourteen patients in the same stage of ductal invasive breast cancer were involved in the study, divided in two randomized groups. One group was subjected to take IP6 + Inositol while the other group was taking placebo. In both groups of patients the same laboratory parameters were monitored. When the treatment was finished, all patients have filled questionnaires QLQ C30 and QLQ-BR23 to determine the quality of life. Patients receiving chemotherapy, along with IP6 + Inositol did not have cytopenia, drop in leukocyte and platelet counts. Red blood cell counts and tumor markers were unaltered in both groups. However, patients who took IP6 + Inositol had significantly better quality of life (p = 0.05) and functional status (p = 0.0003) and were able to perform their daily activities. IP6 + Inositol as an adjunctive therapy is valuable help in ameliorating the side effects and preserving quality of life among the patients treated with chemotherapy.

  8. Biodegradable magnesium-based screw clinically equivalent to titanium screw in hallux valgus surgery: short term results of the first prospective, randomized, controlled clinical pilot study

    PubMed Central

    2013-01-01

    Purpose Nondegradable steel-and titanium-based implants are commonly used in orthopedic surgery. Although they provide maximal stability, they are also associated with interference on imaging modalities, may induce stress shielding, and additional explantation procedures may be necessary. Alternatively, degradable polymer implants are mechanically weaker and induce foreign body reactions. Degradable magnesium-based stents are currently being investigated in clinical trials for use in cardiovascular medicine. The magnesium alloy MgYREZr demonstrates good biocompatibility and osteoconductive properties. The aim of this prospective, randomized, clinical pilot trial was to determine if magnesium-based MgYREZr screws are equivalent to standard titanium screws for fixation during chevron osteotomy in patients with a mild hallux valgus. Methods Patients (n=26) were randomly assigned to undergo osteosynthesis using either titanium or degradable magnesium-based implants of the same design. The 6 month follow-up period included clinical, laboratory, and radiographic assessments. Results No significant differences were found in terms of the American Orthopaedic Foot and Ankle Society (AOFAS) score for hallux, visual analog scale for pain assessment, or range of motion (ROM) of the first metatarsophalangeal joint (MTPJ). No foreign body reactions, osteolysis, or systemic inflammatory reactions were detected. The groups were not significantly different in terms of radiographic or laboratory results. Conclusion The radiographic and clinical results of this prospective controlled study demonstrate that degradable magnesium-based screws are equivalent to titanium screws for the treatment of mild hallux valgus deformities. PMID:23819489

  9. Platelet-rich fibrin in arthroscopic repair of massive rotator cuff tears: a prospective randomized pilot clinical trial.

    PubMed

    Antuña, Samuel; Barco, Raúl; Martínez Diez, José M; Sánchez Márquez, José Miguel

    2013-02-01

    The objective of this study was to prospectively evaluate the feasibility of a large- scale project on the influence of local application of Platelet Rich Fibrin (PRF) on the functional outcome and integrity of the arthroscopically repaired tendons in patients with massive tears of the rotator cuff. A prospective, randomized pilot clinical trial was performed on 28 patients (22 females, 6 males) with an average age of 65 years (range: 53 to 77) undergoing complete arthroscopic repair of a massive rotator cuff tear. After the repair was completed, 6 ml PRF (Vivostat) was locally applied to the repair site in 14 patients; no similar action was done in the other 14 patients. All patients underwent a clinical examination and an arthro-MRI to evaluate the integrity of the repair, one year after the operation. They were followed clinically for a minimum of 2 years. Functional outcome was evaluated with the Constant and DASH scores. There were no reported complications in either group. None of the patients was lost to follow-up. Globally, the Constant score improved from 45 preoperatively (range: 25 to 65) to 64 at one year (range: 20 to 79) (p < 0.001), with no significant change at two years (mean 63, range: 20 to 77). The VAS for pain improved from 5.6/10 preoperatively to 1.7/10 at the most recent examination (p < 0.001). All but two patients were satisfied. With the numbers of patients available, we could not detect a significant difference in the preoperative (46 vs. 43; p = 037) or postoperative Constant score (61 vs. 68; p = 0.125) between the control group and the PRF group. On arthro-MRI, 19 of the 28 patients (68%) were found to have a large re-tear : 10/14 in the PRF group and 9/14 in the control group. Local application of autologous PRF to the repair site of massive rotator cuffs fully reconstructed arthroscopically failed to improve the clinical outcome and the healing rate, compared with a standard repair. However, a large-scale study would be necessary to

  10. Sinus Floor Augmentation With Ambient Blood and an Absorbable Collagen Sponge: A Prospective Pilot Clinical Study.

    PubMed

    Berberi, Antoine; Nader, Nabih; Bou Assaf, Rita; Fayyad-Kazan, Hussein; Khairalah, Saad; Moukarzel, Nabil

    2017-07-10

    The aim of this study was to clinically, radiologically, and histologically evaluate a sinus augmentation technique using a resorbable collagen sponge to maintain space between the Schneiderian membrane and the residual crestal bone. Patients with partially edentulous maxillae were clinically and radiographically evaluated for implant placement. A total of 10 consecutive patients with the bone height for implant placement (<4.0 mm) were enrolled in the study. The lateral maxillary wall was surgically exposed and the Schneiderian membrane was carefully elevated. A collagen wound dressing was placed in the antral area between the sinus floor and the raised membrane. The vertical sinus floor height was calculated using cone-beam computed tomography before the surgical procedure (baseline) and at 6 months postoperative. Immediately after the second scan, a core biopsy was removed for histological evaluation. The biopsy site was then further prepared for implant placement in the same location. Biopsies showed mature cancellous bone with a predominantly lamellar structure. Well-vascularized intertrabecular spaces were filled with connective tissue and bone marrow. Analysis of bone height changes showed significant mean (SD) differences before and after procedures in anterior (2.67 ± 0.62 mm and 11.15 ± 1.1 mm), medial (2.98 ± 0.55 mm and 10.96 ± 0.77 mm), and posterior (3.17 ± 0.91 mm and 10.63 ± 0.51 mm) maxillary jaw locations (P = 0.005). The collagen sponge provided an effective substrate for osseous regeneration of the sinus floor.

  11. Cognitive behavioral therapy for somatic symptom disorders in later life: a prospective comparative explorative pilot study in two clinical populations.

    PubMed

    Verdurmen, Michelle Jh; Videler, Arjan C; Kamperman, Astrid M; Khasho, David; van der Feltz-Cornelis, Christina M

    2017-01-01

    Elderly patients with somatic symptom disorder (SSD) put a great burden on the health care delivery system. Cognitive behavioral therapy (CBT) is effective in adults with SSD. However, no studies have been conducted yet into CBT for SSD in later life. We explored the feasibility of CBT for SSD in the elderly. This is a prospective pilot study comparing two outpatient specialty mental health settings for adults (<60 years; n=13) and for elderly patients (≥60 years; n=9) with SSD. Intervention was 18 structured, protocoled, and supervised CBT sessions. Outcomes were somatic symptoms, pain intensity, pain disability, quality of life, depressive symptoms, and generalized anxiety symptoms. Feasibility of the CBT intervention was explored with self-developed questions, both for the therapists and the patients. Both therapists and elderly patients evaluated the treatment as positive. Somatic symptoms improved significantly in the adult group but not in the elderly group. There was a large, significant decrease in pain intensity and pain disability in elderly patients compared to the adults. Social functioning, vitality, and anxiety symptoms improved significantly in the adults. Presence of chronic medical conditions did not influence these results. This study shows that CBT is feasible as a treatment for SSD in older adults and has encouraging results. Replication in an RCT is warranted.

  12. Birch pollen influence the severity of atopic eczema - prospective clinical cohort pilot study and ex vivo penetration study.

    PubMed

    Fölster-Holst, Regina; Galecka, Jagoda; Weißmantel, Sigo; Dickschat, Ute; Rippke, Frank; Bohnsack, Kerstin; Werfel, Thomas; Wichmann, Katja; Buchner, Matthias; Schwarz, Thomas; Vogt, Annika; Lademann, Jürgen; Meinke, Martina C

    2015-01-01

    There is little clinical evidence for a correlation between the severity of atopic eczema (AE) and pollen exposition. To obtain more data, we performed a clinical cohort pilot study about the influence of pollen on AE between sensitized and nonsensitized subjects and an experimental study addressing the cutaneous penetration of pollen into the skin. Fifty-five patients were monitored during birch pollen season. To study the cutaneous penetration, grass pollen allergens were applied on excised skin and the uptake in CD1c-expressing dendritic cells was investigated. The correlation between environmental pollen load and severity of the Scoring Atopic Dermatitis (SCORAD) score and pruritus was observed, regardless of the status of sensitization. The sensitized group recovered significantly worse after the birch pollen season. Remarkably higher amounts of pollen allergens taken up by CD1c cells were detected in epidermal cells derived from skin explants with a disturbed epidermal barrier. These findings suggest an exacerbating role of pollen in AE utilizing the epidermal route.

  13. Birch pollen influence the severity of atopic eczema – prospective clinical cohort pilot study and ex vivo penetration study

    PubMed Central

    Fölster-Holst, Regina; Galecka, Jagoda; Weißmantel, Sigo; Dickschat, Ute; Rippke, Frank; Bohnsack, Kerstin; Werfel, Thomas; Wichmann, Katja; Buchner, Matthias; Schwarz, Thomas; Vogt, Annika; Lademann, Jürgen; Meinke, Martina C

    2015-01-01

    There is little clinical evidence for a correlation between the severity of atopic eczema (AE) and pollen exposition. To obtain more data, we performed a clinical cohort pilot study about the influence of pollen on AE between sensitized and nonsensitized subjects and an experimental study addressing the cutaneous penetration of pollen into the skin. Fifty-five patients were monitored during birch pollen season. To study the cutaneous penetration, grass pollen allergens were applied on excised skin and the uptake in CD1c-expressing dendritic cells was investigated. The correlation between environmental pollen load and severity of the Scoring Atopic Dermatitis (SCORAD) score and pruritus was observed, regardless of the status of sensitization. The sensitized group recovered significantly worse after the birch pollen season. Remarkably higher amounts of pollen allergens taken up by CD1c cells were detected in epidermal cells derived from skin explants with a disturbed epidermal barrier. These findings suggest an exacerbating role of pollen in AE utilizing the epidermal route. PMID:26604810

  14. A Prospective, Randomized Pilot Trial of Model-Based Warfarin Dose Initiation using CYP2C9 Genotype and Clinical Data

    PubMed Central

    Hillman, Michael A.; Wilke, Russell A.; Yale, Steven H.; Vidaillet, Humberto J.; Caldwell, Michael D.; Glurich, Ingrid; Berg, Richard L.; Schmelzer, John; Burmester, James K.

    2005-01-01

    Background: Rapid genetic screening for cytochrome P450 (CYP) 2C9 variants may play a role in improving the efficacy and safety of warfarin in individuals with CYP2C9 variants. The feasibility of prospective CYP2C9 model-based warfarin dosing has not yet been assessed. Objectives: To evaluate the feasibility of applying a CYP2C9 gene-based warfarin dosing model in clinical practice. Design: Prospective, randomized, single-blinded clinical pilot trial. Setting: Large multispecialty group practice. Patients: Candidates were recruited from a list of clinic patients eligible for warfarin initiation. This included patients with newly diagnosed thromboembolic disease or atrial arrhythmia, as well as patients anticipating elective valvuloplasty or arthroplasty. Patients who previously received warfarin were excluded. Interventions: Subjects were randomized to receive either 1) a standard initiation dose of 5 mg warfarin/day, or 2) rapid CYP2C9 genotyping and an initiation dose determined using parameters estimated from a previously published multivariate model [including age, body size, co-morbidity (e.g., diabetes), clinical indication (e.g., valvuloplasty) and CYP2C9 genotype]. Measurements: Primary outcome measurements were patient willingness to participate, physician willingness to refer, sample processing time, ability to administer calculated dosage and adequacy of follow-up. Limitations: This pilot trial was designed to assess the feasibility of model-based warfarin dosing. Power was insufficient for statistical comparison of adverse event rates. Results: Forty-three of 117 patients had no prior warfarin treatment and were eligible. Five declined to participate. Twenty patients were randomized to a standard initiation dose of 5 mg daily. Eighteen patients were randomized to model-based dosing. All but one participant received the assigned initiation dose. Blood draw to dosage calculation time (including genotyping) required approximately 4 hours. Six adverse

  15. Clinical and Financial Impact of Pharmacist Involvement in Discharge Medication Reconciliation at an Academic Medical Center: A Prospective Pilot Study.

    PubMed

    Sebaaly, Jamie; Parsons, Laura Beth; Pilch, Nicole A Weimert; Bullington, Wendy; Hayes, Genevieve L; Easterling, Heather

    2015-06-01

    Medication reconciliation is one of the more challenging aspects of inpatient care, and its accuracy is paramount to safe transitions of care. Studies have shown that pharmacists have a role in medication reconciliation through improving patient safety and avoiding costs associated with medication errors. The wide-scale use of pharmacists in this process has been limited by time constraints, cost, and lack of resources. This study evaluates the impact of pharmacists in resolving medication errors, decreasing readmission rates, and reducing institutional costs during the discharge medication reconciliation process. Pharmacists evaluated discharge medication reconciliation documentation for patients to determine its accuracy, the accuracy of the admission reconciliation documentation, and any potential issues unrelated to accuracy. Analysis of these data determined the time required for pharmacist involvement, the number of errors identified by pharmacists, the quality of pharmacist interventions, the cost avoidance for each error, and the overall impact on hospital readmission. During the 7-week study period, pharmacists performed 67 discharge medication reviews and identified 84 errors. Seventy-five percent were considered to be significant and 6% were considered to be serious. The 30-day readmission rate in the study cohort was 18% compared with 20% in the control group. Based on the clinical severity scale and pharmacist salaries, pharmacist interventions resulted in $42,300 in cost avoidance. Pharmacists involved in this pilot discharge process identified and resolved significant errors on medication reconciliation orders that resulted in a financial benefit to the institution.

  16. Clinical and Financial Impact of Pharmacist Involvement in Discharge Medication Reconciliation at an Academic Medical Center: A Prospective Pilot Study

    PubMed Central

    Parsons, Laura Beth; Pilch, Nicole A. (Weimert); Bullington, Wendy; Hayes, Genevieve L.; Easterling, Heather

    2015-01-01

    Background: Medication reconciliation is one of the more challenging aspects of inpatient care, and its accuracy is paramount to safe transitions of care. Studies have shown that pharmacists have a role in medication reconciliation through improving patient safety and avoiding costs associated with medication errors. The wide-scale use of pharmacists in this process has been limited by time constraints, cost, and lack of resources. Objective: This study evaluates the impact of pharmacists in resolving medication errors, decreasing readmission rates, and reducing institutional costs during the discharge medication reconciliation process. Methods: Pharmacists evaluated discharge medication reconciliation documentation for patients to determine its accuracy, the accuracy of the admission reconciliation documentation, and any potential issues unrelated to accuracy. Analysis of these data determined the time required for pharmacist involvement, the number of errors identified by pharmacists, the quality of pharmacist interventions, the cost avoidance for each error, and the overall impact on hospital readmission. Results: During the 7-week study period, pharmacists performed 67 discharge medication reviews and identified 84 errors. Seventy-five percent were considered to be significant and 6% were considered to be serious. The 30-day readmission rate in the study cohort was 18% compared with 20% in the control group. Based on the clinical severity scale and pharmacist salaries, pharmacist interventions resulted in $42,300 in cost avoidance. Conclusion: Pharmacists involved in this pilot discharge process identified and resolved significant errors on medication reconciliation orders that resulted in a financial benefit to the institution. PMID:26405342

  17. Alveolar ridge preservation using autogenous tooth graft versus beta-tricalcium phosphate alloplast: A randomized, controlled, prospective, clinical pilot study

    PubMed Central

    Joshi, Chaitanya Pradeep; Dani, Nitin Hemchandra; Khedkar, Smita Uday

    2016-01-01

    Background: A randomized, prospective clinical, radiographical, and histological study was conducted to evaluate healing after alveolar ridge preservation technique using two different graft materials, namely, a novel autogenous graft material i. e., autogenous tooth graft (ATG) and beta-tricalcium phosphate (β-TCP) alloplast. Materials and Methods: Fifteen patients undergoing extraction of at least three teeth were selected. Atraumatic extractions were performed. Of the three extraction sockets, one was grafted with ATG, other with β-TCP, and the third was left ungrafted. Cone-beam computed tomography scans were taken immediately after grafting and 4 months postoperatively to check the changes in alveolar crest height and width at all the sites. Three patients in whom implant placement was done after complete healing; bone samples were harvested using a 3 mm diameter trephine during osteotomy preparation from both the ridge preserved sites and studied histologically. Results: There was a statistically significant difference when the changes in width and height of alveolar crest were compared within all the three groups (P < 0.05). Among three sites, ATG-grafted sites showed the most superior results with a minimal reduction in alveolar crest height and width. Histological analysis also showed the same trend with more new bone formation at ATG-grafted sites as compared to β-TCP-grafted sites. Conclusion: Postextraction, ridge preservation leads to more predictable maintenance of alveolar ridge height and width. ATG as compared to β-TCP provided superior results. Based on this, we conclude that ATG material can serve as a better alternative to conventional bone graft materials. PMID:28298826

  18. Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study

    PubMed Central

    Schumacher, Andrew; Sikov, William M.; Quesenberry, Matthew I.; Safran, Howard; Khurshid, Humera; Mitchell, Kristen M.

    2017-01-01

    Background Informed consent forms (ICFs) for oncology clinical trials have grown increasingly longer and more complex. We evaluated objective understanding of critical components of informed consent among patients enrolling in contemporary trials of conventional or novel biologic/targeted therapies. Methods We evaluated ICFs for cancer clinical trials for length and readability, and patients registered on those studies were asked to complete a validated 14-question survey assessing their understanding of key characteristics of the trial. Mean scores were compared in groups defined by trial and patient characteristics. Results Fifty patients, of whom half participated in trials of immunotherapy or biologic/targeted agents and half in trials of conventional therapy, completed the survey. On average, ICFs for industry-originated trials (N = 9 trials) were significantly longer (P < .0001) and had lower Flesch ease-of-reading scores (P = .003) than investigator-initiated trials (N = 11). At least 80% of patients incorrectly responded to three key questions which addressed the experimental nature of their trial therapy, its purported efficacy and potential risks relative to alternative treatments. The mean objective understanding score was 76.9±8.8, but it was statistically significantly lower for patients who had not completed high school (P = .011). The scores did not differ significantly by type of cancer therapy (P = .12) or trial sponsor (P = .38). Conclusions Many participants enrolled on cancer trials had poor understanding of essential elements of their trial. In order to ensure true informed consent, innovative approaches, such as expanded in-person counseling adapted to the patient’s education level or cultural characteristics should be evaluated across socio-demographic groups. Trial registration Clinicaltrials.gov NCT01772511 PMID:28235011

  19. Clinical impact of pharmacogenetic profiling with a clinical decision support tool in polypharmacy home health patients: A prospective pilot randomized controlled trial

    PubMed Central

    Henderson, John C.; Neradilek, Moni B.; Moyer, Nicolas A.; Ashcraft, Kristine C.; Thirumaran, Ranjit K.

    2017-01-01

    Background In polypharmacy patients under home health management, pharmacogenetic testing coupled with guidance from a clinical decision support tool (CDST) on reducing drug, gene, and cumulative interaction risk may provide valuable insights in prescription drug treatment, reducing re-hospitalization and emergency department (ED) visits. We assessed the clinical impact of pharmacogenetic profiling integrating binary and cumulative drug and gene interaction warnings on home health polypharmacy patients. Methods and findings This prospective, open-label, randomized controlled trial was conducted at one hospital-based home health agency between February 2015 and February 2016. Recruitment came from patient referrals to home health at hospital discharge. Eligible patients were aged 50 years and older and taking or initiating treatment with medications with potential or significant drug-gene-based interactions. Subjects (n = 110) were randomized to pharmacogenetic profiling (n = 57). The study pharmacist reviewed drug-drug, drug-gene, and cumulative drug and/or gene interactions using the YouScript® CDST to provide drug therapy recommendations to clinicians. The control group (n = 53) received treatment as usual including pharmacist guided medication management using a standard drug information resource. The primary outcome measure was the number of re-hospitalizations and ED visits at 30 and 60 days after discharge from the hospital. The mean number of re-hospitalizations per patient in the tested vs. untested group was 0.25 vs. 0.38 at 30 days (relative risk (RR), 0.65; 95% confidence interval (CI), 0.32–1.28; P = 0.21) and 0.33 vs. 0.70 at 60 days following enrollment (RR, 0.48; 95% CI, 0.27–0.82; P = 0.007). The mean number of ED visits per patient in the tested vs. untested group was 0.25 vs. 0.40 at 30 days (RR, 0.62; 95% CI, 0.31–1.21; P = 0.16) and 0.39 vs. 0.66 at 60 days (RR, 0.58; 95% CI, 0.34–0.99; P = 0.045). Differences in composite outcomes at

  20. Prospective cohort pilot study of 2-visit CAD/CAM monolithic complete dentures and implant-retained overdentures: Clinical and patient-centered outcomes.

    PubMed

    Bidra, Avinash S; Farrell, Kimberly; Burnham, David; Dhingra, Ajay; Taylor, Thomas D; Kuo, Chia-Ling

    2016-05-01

    Presently, no studies have evaluated clinical outcomes or patient-centered outcomes for complete dentures fabricated with computer-aided design and computer aided manufacturing (CAD/CAM) technology. The purpose of this prospective cohort pilot study was to evaluate the clinical and patient-centered outcomes for CAD/CAM monolithic dentures fabricated in 2 visits. Twenty participants with an existing set of maxillary complete dentures opposing either mandibular complete dentures or implant-retained overdentures that required replacement were recruited in this study. A 2-visit duplicate denture protocol was used to fabricate 40 arches of monolithic dentures with CAD/CAM technology. A 100-mm visual analog scale (VAS) instrument was then used to record 12 outcomes at baseline and at 1-year follow-up. Predetermined values were assigned to grade the VAS rating of each outcome as favorable (70.1-100) and unfavorable (≤70). Favorable ratings were sub-divided as excellent (90.1-100), good (80.1-90), and fair (70.1-80). The clinical outcomes were evaluated independently by 2 experienced prosthodontists at baseline and at 1-year follow-up. Patients evaluated the corresponding patient-centered outcomes during the same time intervals. Additional descriptive variables were also recorded. Each clinical and patient-centered outcome was summarized by medians and ranges. Differences in all ratings recorded at baseline and at 1 year were tested by 1-sided sign test (α=.05). Of 20 participants, 3 were lost to follow-up, and 3 were unsatisfied with the digital dentures and withdrew from the study. These 3 participants were considered treatment failures. Of the 14 remaining participants, 9 had implant-retained mandibular overdentures, and 5 had conventional mandibular complete dentures. For clinical outcomes, the 12 studied outcomes were favorably evaluated by the 2 prosthodontist judges at the 1-year follow-up. Evaluations showed minimal differences between baseline and 1 year. An

  1. Evaluation of atorvastatin efficacy and toxicity on spermatozoa, accessory glands and gonadal hormones of healthy men: a pilot prospective clinical trial

    PubMed Central

    2014-01-01

    Background Recommendations for cardiovascular disease prevention advocate lowering both cholesterol and low-density lipoprotein cholesterol systemic levels, notably by statin intake. However, statins are the subject of questions concerning their impact on male fertility. This study aimed to evaluate, by a prospective pilot assay, the efficacy and the toxicity of a decrease of cholesterol blood levels, induced by atorvastatin on semen quality and sexual hormone levels of healthy, normocholesterolaemic and normozoospermic men. Methods Atorvastatin (10 mg daily) was administrated orally during 5 months to 17 men with normal plasma lipid and standard semen parameters. Spermatozoa parameters, accessory gland markers, semen lipid levels and blood levels of gonadal hormones were assayed before statin intake, during the treatment, and 3 months after its withdrawal. Results Atorvastatin treatment significantly decreased circulating low-density lipoprotein cholesterol (LDL-C) and total cholesterol concentrations by 42% and 24% (p < 0.0001) respectively, and reached the efficacy objective of the protocol. During atorvastatin therapy and/or 3 months after its withdrawal numerous semen parameters were significantly modified, such as total number of spermatozoa (-31%, p < 0.05), vitality (-9.5%, p < 0.05), total motility (+7.5%, p < 0.05), morphology (head, neck and midpiece abnormalities, p < 0.05), and the kinetics of acrosome reaction (p < 0.05). Seminal concentrations of acid phosphatases (p < 0.01), α-glucosidase (p < 0.05) and L-carnitine (p < 0.05) were also decreased during the therapy, indicating an alteration of prostatic and epididymal functions. Moreover, we measured at least one altered semen parameter in 35% of the subjects during atorvastatin treatment, and in 65% of the subjects after withdrawal, which led us to consider that atorvastatin is unsafe in the context of our study. Conclusions Our results show for the first

  2. Effectiveness of Digital Medicines to Improve Clinical Outcomes in Patients with Uncontrolled Hypertension and Type 2 Diabetes: Prospective, Open-Label, Cluster-Randomized Pilot Clinical Trial

    PubMed Central

    Frias, Juan; Raja, Praveen; Kim, Yoona; Savage, George; Osterberg, Lars

    2017-01-01

    Background Hypertension and type 2 diabetes mellitus are major modifiable risk factors for cardiac, cerebrovascular, and kidney diseases. Reasons for poor disease control include nonadherence, lack of patient engagement, and therapeutic inertia. Objective The aim of this study was to assess the impact on clinic-measured blood pressure (BP) and glycated hemoglobin (HbA1c) using a digital medicine offering (DMO) that measures medication ingestion adherence, physical activity, and rest using digital medicines (medication taken with ingestible sensor), wearable sensor patches, and a mobile device app. Methods Participants with elevated systolic BP (SBP ≥140 mm Hg) and HbA1c (≥7%) failing antihypertensive (≥2 medications) and oral diabetes therapy were enrolled in this three-arm, 12-week, cluster-randomized study. Participants used DMO (includes digital medicines, the wearable sensor patch, and the mobile device app) for 4 or 12 weeks or received usual care based on site randomization. Providers in the DMO arms could review the DMO data via a Web portal. In all three arms, providers were instructed to make medical decisions (medication titration, adherence counseling, education, and lifestyle coaching) on all available clinical information at each visit. Primary outcome was change in SBP at week 4. Other outcomes included change in SBP and HbA1c at week 12, and low-density lipoprotein cholesterol (LDL-C) and diastolic blood pressure (DBP) at weeks 4 and 12, as well as proportion of patients at BP goal (<140/90 mm Hg) at weeks 4 and 12, medical decisions, and medication adherence patterns. Results Final analysis included 109 participants (12 sites; age: mean 58.7, SD years; female: 49.5%, 54/109; Hispanic: 45.9%, 50/109; income ≤ US $20,000: 56.9%, 62/109; and ≤ high school education: 52.3%, 57/109). The DMO groups had 80 participants (7 sites) and usual care had 29 participants (5 sites). At week 4, DMO resulted in a statistically greater SBP reduction than

  3. Impact of an adherence clinic on behavioral outcomes and virologic response in treatment of HIV infection: a prospective, randomized, controlled pilot study.

    PubMed

    Rathbun, R Chris; Farmer, Kevin C; Stephens, Johnny R; Lockhart, Staci M

    2005-02-01

    The aim of this randomized, controlled pilot study was to examine the impact of a pharmacist operated adherence clinic on adherence to highly active antiretroviral therapy (HAART) and viral suppression in patients with HIV over 28 weeks. Consecutive eligible patients initiating HAART at an indigent-care clinic were randomized to an adherence clinic or to standard care (information provided by physician or nurse practitioner) for education and monitoring. Group assignment was stratified before randomization according to regimen complexity and potential tolerability. Adherence (electronic monitoring and patient self-report) and viral load (reverse-transcription polymerase chain reaction) were assessed at weeks 4, 16, and 28. Thirty-three randomized patients (adherence clinic, n = 16; standard care, n = 17) comprised the intent-to-treat population. The groups were well-matched for demographics and antiretroviral regimen. The median age was 38.0 years in both groups. Most patients were male (85%), had previously used HAART (78%), and had an AIDS diagnosis (79%). Mean (SD) adherence at weeks 4, 16, and 28 was 86% (27%), 77% (28%), and 74% (31%) in the adherence clinic group versus 73% (32%), 56% (39%), and 51% (41%) in the standard care group (week-16 difference, 21% [90% CI, 1%-42%]; week-28 difference, 23% [90% CI, 1%-44%]). Sixty-nine percent of patients in the adherence clinic group took their medication on schedule versus 42% in the standard care group (P = 0.025); mean decline in adherence from weeks 4 to 28 was 12% in the adherence clinic group (P = 0.15) versus 22% in the standard care group (P = 0.002). HIV-1 RNA levels were <400 copies/mL at weeks 4, 16, and 28 in 63%, 100%, and 94% of the adherence clinic group and 29% (P = NS), 71% (P = 0.04), and 65% (P = NS) of the standard care group. In this preliminary trial, an adherence clinic model improved adherence to HAART and virologic response over 28 weeks in the patients studied.

  4. Cross-border reproductive care in North America: a pilot study testing a prospective data collection program for in vitro fertilization clinics in Canada and the United States.

    PubMed

    Hughes, Edward G; Sawyer, Angie; DeJean, Deirdre; Adamson, G David

    2016-03-01

    To develop and test a nonidentifying prospective data collection system for cross-border reproductive care (CBRC) in Canada and the United States (U.S.). Survey and cross-sectional study. Fertility clinics. Women traveling to and from Canada and the U.S. for reproductive care. None. Patients' home country, reason for crossing borders, and type of care received. Of 32 Canadian and 440 U.S. clinics contacted, seven and 46, respectively, responded to the initial questionnaire. Three out of seven Canadian and 44 out of 46 U.S. clinics reported providing CBRC. Seventy five percent agreed that nonidentifying data on country of origin and reason for travel should be collected. However, only one of seven Canadian and none of 46 U.S. clinics that expressed initial interest actually collected data, despite multiple communications. Although CBRC is a major component of assisted reproductive technology in North America (3%-10% of IVF cycles are provided to out-of-country patients in Canada and the U.S.), clinicians are not motivated to collect the simplest of data regarding CBRC patients. Despite this, reliable data are needed to help better understand the reasons for and impact of CBRC. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  5. Clinical, Laboratorial, and Urodynamic Findings of Prostatic Artery Embolization for the Treatment of Urinary Retention Related to Benign Prostatic Hyperplasia. A Prospective Single-Center Pilot Study

    SciTech Connect

    Antunes, Alberto A.; Carnevale, Francisco C. Motta Leal Filho, Joaquim M. da; Yoshinaga, Eduardo M.; Cerri, Luciana M. O.; Baroni, Ronaldo H.; Marcelino, Antonio S. Z.; Cerri, Giovanni G.; Srougi, Miguel

    2013-08-01

    PurposeThis study was designed to describe the clinical, laboratorial, and urodynamic findings of prostatic artery embolization (PAE) in patients with urinary retention due to benign prostatic hyperplasia (BPH).MethodsA prospective study of 11 patients with urinary retention due to BPH was conducted. Patients underwent physical examination, prostate specific antigen (PSA) measurement, transrectal ultrasound, and magnetic resonance imaging. International prostate symptom score (IPSS), quality of life (QoL), and urodynamic testing were used to assess the outcome before and after 1 year.ResultsClinical success was 91 % (10/11 patients) with a mean follow-up of 22.3 months (range, 12-41 months). At the first year follow-up, the mean IPSS score was 2.8 points (p = 0.04), mean QoL was 0.4 points (p = 0.001), mean PSA decreased from 10.1 to 4.3 ng/mL (p = 0.003), maximum urinary flow (Qmax) improved from 4.2 to 10.8 mL/sec (p = 0.009), and detrusor pressure (Pdet) decreased from 85.7 to 51.5 cm H{sub 2}O (p = 0.007). Before PAE, Bladder Outlet Obstruction Index (BOOI) showed values >40 in 100 % of patients. After PAE, 30 % of patients were >40 (obstructed), 40 % were between 20 and 40 (undetermined), and 30 % were <20 (unobstructed). Patients with a BOOI <20 had higher PSA values at 1-day after PAE.ConclusionsClinical and urodynamic parameters improved significantly after PAE in patients with acute urinary retention due to BPH. Total PSA at day 1 after PAE was higher in patients with unobstructed values in pressure flow studies.

  6. Safety and efficacy evaluation of Ayurvedic treatment (Arjuna powder and Arogyavardhini Vati) in dyslipidemia patients: A pilot prospective cohort clinical study

    PubMed Central

    Kumar, Gajendra; Srivastava, Amita; Sharma, Surinder Kumar; Gupta, Yogendra Kumar

    2012-01-01

    Cardiovascular disease has multifaceted in which dyslipidemia, inflammation, and immunity play an important role. Arjuna powder and Arogyavardhini Vati used for centuries has potential for combating these factors. Therefore, the objective of this study was to evaluate the safety and efficacy of Ayurvedic treatment (Arjuna powder and Arogyavardhini Vati) for dyslipidemia patients. Total of 108 patients were screened at CGHS Ayurvedic Hospital, New Delhi. Ninety-six patients satisfied inclusion criteria, and signed informed consent and detailed medical history was recorded. Arjuna powder (5 g, BD) for 3 weeks and then Arogyavardhini Vati (500 mg, BD) for 4 weeks were prescribed to the patients. The primary efficacy endpoint was reduction in serum total cholesterol, LDL, triglycerides, and increased HDL levels. Secondary endpoints included reduction in serum C-Reactive Protein (CRP) and blood glucose levels. Safety assessments included hepatic function (aminotransferase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), bilirubin, and β2 microglobulin), renal function (urea and creatinine and NGAL) tests, and urine mercury level. The study was completed by 87 patients. The male and female patients were 65.5% (57/87) and 34.5% (30/87), respectively. There was a significant reduction in total cholesterol, LDL, triglycerides, CRP, and blood glucose. However, raised HDL level was also observed. Safety assessment results showed no significant change in serum ALT, AST, ALP and bilirubin, urea, creatinine β2 microglobulin, and NGAL levels at the end of study as compared to the baseline levels. In conclusion, the results of the present prospective cohort study showed that Ayurvedic treatment (Arjuna powder and Arogyavardhini Vati) is safe and effective for dyslipidemia. PMID:23559790

  7. A prospective pilot clinical trial evaluating the utility of a dynamic near-infrared imaging device for characterizing suspicious breast lesions

    PubMed Central

    Xu, Ronald X; Young, Donn C; Mao, Jimmy J; Povoski, Stephen P

    2007-01-01

    Introduction Characterizing and differentiating between malignant tumors, benign tumors, and normal breast tissue is increasingly important in the patient presenting with breast problems. Near-infrared diffuse optical imaging and spectroscopy is capable of measuring multiple physiologic parameters of biological tissue systems and may have clinical applications for assessing the development and progression of neoplastic processes, including breast cancer. The currently available application of near-infrared imaging technology for the breast, however, is compromised by low spatial resolution, tissue heterogeneity, and interpatient variation. Materials and methods We tested a dynamic near-infrared imaging schema for the characterization of suspicious breast lesions identified on diagnostic clinical ultrasound. A portable handheld near-infrared tissue imaging device (P-Scan; ViOptix Inc., Fremont, CA, USA) was utilized. An external mechanical compression force was applied to breast tissue. The tissue oxygen saturation and hemoglobin concentration were recorded simultaneously by the handheld near-infrared imaging device. Twelve categories of dynamic tissue parameters were derived based on real-time measurements of the tissue hemoglobin concentration and the oxygen saturation. Results Fifty suspicious breast lesions were evaluated in 48 patients. Statistical analyses were carried out on 36 out of 50 datasets that satisfied our inclusion criteria. Suspicious breast lesions identified on diagnostic clinical ultrasound had lower oxygenation and higher hemoglobin concentration than the surrounding normal breast tissue. Furthermore, histopathologic-proven malignant breast tumors had a lower differential hemoglobin contrast (that is, the difference of hemoglobin concentration variability between the suspicious breast lesion and the normal breast parenchyma located remotely elsewhere within the ipsilateral breast) as compared with histopathologic-proven benign breast lesions

  8. Clinical evaluation of the role of tulsi and turmeric in the management of oral submucous fibrosis: A pilot, prospective observational study

    PubMed Central

    Srivastava, Adit; Agarwal, Rahul; Chaturvedi, T. P.; Chandra, Akhilesh; Singh, O. P.

    2015-01-01

    The aim of the present study was to investigate the clinical efficacy of herbal medicines (1 gm tulsi and 1 gm turmeric mixed in glycerine base) for the treatment of oral submucous fibrosis (OSMF). Forty-one patients in the age group of 17- 56 years without any systemic complications were included in the study. The patients were treated with medicines, which were to be applied 3-4 times a day. Blood samples were collected before and after treatment to screen for any systemic changes due to these medications. Burning sensation and mouth opening were recorded before and after treatment. Patients were followed up on monthly subsequent visits for three months. Changes in the burning sensation on visual analogue scale (VAS) scale and difference in the mouth opening were analyzed statistically. A statistically significant improvement was seen in both burning sensation and mouth opening. Tulsi and turmeric offers a safe and efficacious combination of natural products available for symptomatic treatment of OSMF. PMID:25878464

  9. The Role and Interpretation of Pilot Studies in Clinical Research

    PubMed Central

    Leon, Andrew C.; Davis, Lori L.; Kraemer, Helena C.

    2010-01-01

    Pilot studies represent a fundamental phase of the research process. The purpose of conducting a pilot study is to examine the feasibility of an approach that is intended to be used in a larger scale study. The roles and limitations of pilot studies are described here using a clinical trial as an example. A pilot study can be used to evaluate the feasibility of recruitment, randomization, retention, assessment procedures, new methods, and implementation of the novel intervention. A pilot study is not a hypothesis testing study. Safety, efficacy and effectiveness are not evaluated in a pilot. Contrary to tradition, a pilot study does not provide a meaningful effect size estimate for planning subsequent studies due to the imprecision inherent in data from small samples. Feasibility results do not necessarily generalize beyond the inclusion and exclusion criteria of the pilot design. A pilot study is a requisite initial step in exploring a novel intervention or an innovative application of an intervention. Pilot results can inform feasibility and identify modifications needed in the design of a larger, ensuing hypothesis testing study. Investigators should be forthright in stating these objectives of a pilot study. Grant reviewers and other stakeholders should expect no more. PMID:21035130

  10. A prospective randomised clinical pilot study to compare the effectiveness of Biobrane® synthetic wound dressing, with or without autologous cell suspension, to the local standard treatment regimen in paediatric scald injuries.

    PubMed

    Wood, F; Martin, L; Lewis, D; Rawlins, J; McWilliams, T; Burrows, S; Rea, S

    2012-09-01

    Scald is the most common cause of burn in children in Australia. The time taken by the burn wound to heal impacts on scar outcome. Commonly scald injuries are treated conservatively; in our unit the practice is that if healing does not occur within 10 days, surgery is used to aid healing with the aim of improving scar outcome. This randomised controlled pilot study compares early treatment regimens to facilitate tissue salvage and reduce the incidence of definitive surgery at 10 days following scald injury. All paediatric patients with partial thickness scald injury were clinically assessed between July 1, 2009 and June 30, 2010. A burn of 2% TBSAB or more and deemed not to heal within 10 days, were considered for the trial. These patients were randomised to one of three treatment arms: the local standard treatment (Intrasite™, Acticoat™ and Duoderm(®) dressings every 2-3 days) with surgery at 10 days, Biobrane(®) only or Biobrane(®) and autologous cell suspension using the ReCell(®) kit. The primary outcome was surgery performed after 10 days; secondary outcomes were rates of healing, pain experienced, and scar outcomes. 15% of scald presentations in the 12 month period met the eligibility criteria. 13 patients were recruited into the pilot study; early intervention was associated with a decreased time to healing with fewer dressing changes, less pain and better scar outcomes. Investment of surgical resources in the acute stages within 4 days of injury saved on nursing time, dressing, analgesic and scar management costs. Copyright © 2012 Elsevier Ltd and ISBI. All rights reserved.

  11. Prospective, randomized, open-label, pilot clinical trial comparing the effects of dexamethasone coadministered with diclofenac potassium or acetaminophen and diclofenac potassium monotherapy after third-molar extraction in adults

    PubMed Central

    Bamgbose, Babatunde Olamide; Akinwande, Jelili Adisa; Adeyemo, Wasiu Lanre; Ladeinde, Akinola Ladipo; Arotiba, Godwin Toyin; Ogunlewe, Mobolanle Olugbemiga

    2006-01-01

    Background: Patients who experience pain, swelling, and trismus after third-molar extraction are reported to experience a 3-fold higher rate of adverse effects (AEs) on quality of life compared with those who are asymptomatic after this surgery. Therefore, investigators emphasize the necessity for better control of this triad of sequelae. Steroids can reduce the risk for physiologic processes of inflammation, thereby suppressing the development of inflammation. Objective: The aim of this study was to compare the effects of dexamethasone 8 mg IM and diclofenac potassium (K) 50 mg PO, dexamethasone 8 mg IM and acetaminophen 1000 mg PO, and monotherapy with diclofenac K 50 mg PO on postoperative pain, swelling, and trismus after surgical removal of third molars. Methods: This prospective, randomized, open-label pilot study was conducted at the Department of Oral and Maxillofacial Surgery, Lagos University Teaching Hospital, Lagos, Nigeria. Patients were randomly allocated to 1 of 3 treatment groups: concomitant treatment with dexamethasone 8 mg IM and diclofenac K 50 mg PO or acetaminophen 1000 mg PO, or monotherapy with diclofenac K 50 mg PO. Overall analgesic efficacy of the drug combinations was assessed for 7 days postoperatively using a 4-point categorical pain-intensity rating scale (0 = no pain; 1 = mild pain; 2 = moderate pain; and 3 = severe pain). Facial swelling was measured in 1 dimension on days 1, 2, and 7 after surgery using a tape measure placed from the tip of the tragus, to gonion, to the tip of the contralateral tragus, and trismus was assessed using interincisal mouth-opening ability, measured using a vernier-calibrated caliper on postoperative days 1, 2, and 7. Tolerability was assessed using direct questioning of the patients at follow-up visits. Results: A total of 150 patients (50 per treatment group) were included in the analysis (76 women, 74 men; mean [SD] age, 26.8 [5.04] years [range, 18–45 years]; 100% Nigerian). The proportion of

  12. Dietary and metabolomic determinants of relapse in ulcerative colitis patients: A pilot prospective cohort study

    PubMed Central

    Keshteli, Ammar Hassanzadeh; van den Brand, Floris F; Madsen, Karen L; Mandal, Rupasri; Valcheva, Rosica; Kroeker, Karen I; Han, Beomsoo; Bell, Rhonda C; Cole, Janis; Hoevers, Thomas; Wishart, David S; Fedorak, Richard N; Dieleman, Levinus A

    2017-01-01

    AIM To identify demographic, clinical, metabolomic, and lifestyle related predictors of relapse in adult ulcerative colitis (UC) patients. METHODS In this prospective pilot study, UC patients in clinical remission were recruited and followed-up at 12 mo to assess a clinical relapse, or not. At baseline information on demographic and clinical parameters was collected. Serum and urine samples were collected for analysis of metabolomic assays using a combined direct infusion/liquid chromatography tandem mass spectrometry and nuclear magnetic resolution spectroscopy. Stool samples were also collected to measure fecal calprotectin (FCP). Dietary assessment was performed using a validated self-administered food frequency questionnaire. RESULTS Twenty patients were included (mean age: 42.7 ± 14.8 years, females: 55%). Seven patients (35%) experienced a clinical relapse during the follow-up period. While 6 patients (66.7%) with normal body weight developed a clinical relapse, 1 UC patient (9.1%) who was overweight/obese relapsed during the follow-up (P = 0.02). At baseline, poultry intake was significantly higher in patients who were still in remission during follow-up (0.9 oz vs 0.2 oz, P = 0.002). Five patients (71.4%) with FCP > 150 μg/g and 2 patients (15.4%) with normal FCP (≤ 150 μg/g) at baseline relapsed during the follow-up (P = 0.02). Interestingly, baseline urinary and serum metabolomic profiling of UC patients with or without clinical relapse within 12 mo showed a significant difference. The most important metabolites that were responsible for this discrimination were trans-aconitate, cystine and acetamide in urine, and 3-hydroxybutyrate, acetoacetate and acetone in serum. CONCLUSION A combination of baseline dietary intake, fecal calprotectin, and metabolomic factors are associated with risk of UC clinical relapse within 12 mo. PMID:28638229

  13. Beliefs of Applied Studio Faculty on Desirable Traits of Prospective Music Education Majors: A Pilot Study

    ERIC Educational Resources Information Center

    Royston, Natalie Steele; Springer, D. Gregory

    2015-01-01

    The purpose of this pilot study was to examine the beliefs of applied music faculty on desirable traits of prospective music education majors. Researcher-designed surveys were sent electronically to applied music faculty at 12 National Association of Schools of Music-accredited institutions randomly selected from each of the four major divisions…

  14. Beliefs of Applied Studio Faculty on Desirable Traits of Prospective Music Education Majors: A Pilot Study

    ERIC Educational Resources Information Center

    Royston, Natalie Steele; Springer, D. Gregory

    2015-01-01

    The purpose of this pilot study was to examine the beliefs of applied music faculty on desirable traits of prospective music education majors. Researcher-designed surveys were sent electronically to applied music faculty at 12 National Association of Schools of Music-accredited institutions randomly selected from each of the four major divisions…

  15. Effects on heart function of neoadjuvant chemotherapy and chemoradiotherapy in patients with cancer in the esophagus or gastroesophageal junction - a prospective cohort pilot study within a randomized clinical trial.

    PubMed

    Lund, Mikael; Alexandersson von Döbeln, Gabriella; Nilsson, Magnus; Winter, Reidar; Lundell, Lars; Tsai, Jon A; Kalman, Sigridur

    2015-01-13

    Neoadjuvant therapy for cancer of the esophagus or gastroesophageal (GE)-junction is well established. The pros and cons of chemoradiotherapy and chemotherapy are debated. Chemoradiotherapy might impair cardiac function eliciting postoperative morbidity. The aim of this pilot study was to describe acute changes in left ventricular function following chemoradiotherapy or chemotherapy. Patients with esophageal and (GE)-junction cancer enrolled at our center into a multicenter trial comparing neoadjuvant chemoradiotherapy and chemotherapy were eligible. Patients were randomized to receive cisplatin and 5-fluorouracil with or without the addition of 40 Gy radiotherapy prior to surgery. Left ventricular function was evaluated using echocardiography and plasma N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) before and after neoadjuvant treatment. The primary outcome measure was left ventricular global strain (GS). Clinical effects were assessed using repeated exercise tests. Linear mixed models were used to analyze the effects of treatment group, and the interaction between groups. 40 patients participated (chemoradiotherapy, n=17; chemotherapy, n=23). In the chemoradiotherapy group there was no change in left ventricular global strain but mitral annular plane systolic excursion (MAPSE) of the ventricular septum, early diastolic filling velocity (E-velocity), and the ratio of early to late ventricular filling velocities (E/A ratio) decreased significantly (p=0.02, p=0.01, and p=0.03, respectively). No changes were observed in the chemotherapy group. There was a trend towards an interaction effect for MAPSE sept and E (p=0.09 and p=0.09). NT-proBNP increased following chemoradiotherapy (p=0.05) but not after chemotherapy (p>0.99), and there was a trend towards an interaction effect (p=0.07). Working capacity decreased following neoadjuvant treatment (chemoradiotherapy p = 0.001, chemotherapy p=0.03) and was more pronounced after chemoradiotherapy with a trend

  16. Prospective markets and design concepts for civilian remotely piloted aircraft

    NASA Technical Reports Server (NTRS)

    Nelms, W. P., Jr.; Gregory, T. J.; Aderhold, J. R.

    1976-01-01

    This paper summarizes a study that examines the technical, economic, and environmental aspects of remotely piloted vehicles (RPVs) in the civil environment. A market survey was conducted in which 35 civil applications of RPVs were identified. For a number of these uses, vehicle and system concepts were defined, benefit and cost comparisons were made with present methods, and the influence of safety and environmental implications was assessed. The results suggest a sizable potential demand for the use of RPVs in the civil sector, and some of the applications show promising cost savings over established methods. A focussed technology effort could provide the safety assurances needed for routine civilian operation of RPVs.

  17. [Clinical dialysis: new problems and new prospects].

    PubMed

    Locatelli, F; Manzoni, C; Pozzoni, P; Pontoriero, G; Di Filippo, L

    2004-01-01

    The main problem nephrologists have to face today is the very high patient morbidity and mortality. A number of traditional and non-traditional risk factors have a role; among these anaemia, hypertension, dislipidemia, abnormalities in calcium-phosphate metabolism, hyperhomocysteinemia and endothelial dysfunction. An important innovation in the field of hemodialysis has been the availability of high-permeable and high-flux membranes, characterized by a high biocompatibility and ultrafiltration coefficient. The development of automatic systems to control ultrafiltration has enabled the utilisation of these membranes in the clinical setting (high-flux hemodialysis, hemofiltration, hemodiafiltration). It is common opinion that high-flux membranes can positively influence cardiovascular instability, but this has not been confirmed by clinical trials. Although preliminary data indicated a favorable effect on the correction of anemia in patients treated with high-permeable membranes, randomized trials have not shown a significant effect. Better control of anemia could be possible by means of on-line treatments, given their higher removal of medium- and large molecules and reduced microbiological and pyrogenic contamination of the dialysate. A number of analyses showed a lower incidence of bone cysts and/or carpal tunnel syndrome in patients treated with high-flux membranes compared to low-flux ones. High-flux treatments could reduce morbidity and mortality in hemodialysis patients. However, despite its large sample size, the HEMO Study has not been capable of showing a statistically significant effect of higher dialysis dose and high-flux membranes on survival and morbidity. The MPO study has been expressively designed to do a prospective evaluation of the long-term effect of membrane permeability on clinical outcomes. These results are greatly awaited.

  18. Prospects of the clinical utilization of melatonin.

    PubMed

    Bubenik, G A; Blask, D E; Brown, G M; Maestroni, G J; Pang, S F; Reiter, R J; Viswanathan, M; Zisapel, N

    1998-01-01

    This review summarizes the present knowledge on melatonin in several areas on physiology and discusses various prospects of its clinical utilization. Ever increasing evidence indicates that melatonin has an immuno-hematopoietic role. In animal studies, melatonin provided protection against gram-negative septic shock, prevented stress-induced immunodepression, and restored immune function after a hemorrhagic shock. In human studies, melatonin amplified the antitumoral activity of interleukin-2. Melatonin has been proven as a powerful cytostatic drug in vitro as well as in vivo. In the human clinical field, melatonin appears to be a promising agent either as a diagnostic or prognostic marker of neoplastic diseases or as a compound used either alone or in combination with the standard cancer treatment. Utilization of melatonin for treatment of rhythm disorders, such as those manifested in jet lag, shift work or blindness, is one of the oldest and the most successful clinical application of this chemical. Low doses of melatonin applied in controlled-release preparation were very effective in improving the sleep latency, increasing the sleep efficiency and rising sleep quality scores in elderly, melatonin-deficient insomniacs. In the cardiovascular system, melatonin seems to regulate the tone of cerebral arteries; melatonin receptors in vascular beds appear to participate in the regulation of body temperature. Heat loss may be the principal mechanism in the initiation of sleepiness caused by melatonin. The role of melatonin in the development of migraine headaches is at present uncertain but more research could result in new ways of treatment. Melatonin is the major messenger of light-dependent periodicity, implicated in the seasonal reproduction of animals and pubertal development in humans. Multiple receptor sites detected in brain and gonadal tissues of birds and mammals of both sexes indicate that melatonin exerts a direct effect on the vertebrate reproductive

  19. Sleep attacks and antiparkinsonian drugs: a pilot prospective pharmacoepidemiologic study.

    PubMed

    Montastruc, J L; Brefel-Courbon, C; Senard, J M; Bagheri, H; Ferreira, J; Rascol, O; Lapeyre-Mestre, M

    2001-01-01

    A prospective survey was performed to characterize the prevalence of sleep attacks and to evaluate precipitating factors in a group of 236 patients with idiopathic Parkinson's disease. Sleep attacks were reported by 72 patients (30.5%). Multivariate analysis showed a marked association between the occurrence of sudden sleep episodes and first autonomic failure, followed by treatment with ropinirole and bromocriptine. The present work underlines the major contributing role of autonomic failure followed by dopamine agonists in the occurrence of such an event. Because a relationship between sleep attacks and not only ropinirole but also bromocriptine treatment was described, the present work suggests that sleep attacks are a common side effect of all dopamine agonists.

  20. Women with epilepsy initiating a progestin IUD: A prospective pilot study of safety and acceptability.

    PubMed

    Davis, Anne R; Saadatmand, Heva J; Pack, Alison

    2016-11-01

    Effective contraception enables women with epilepsy (WWE) to plan their pregnancies and improve outcomes for themselves and their children. Although popular among all women, complex drug interactions limit the efficacy and safety of oral contraceptives (OCs) for WWE. We sought to explore the safety, acceptability, and pharmacokinetic impact of a progestin-containing intrauterine device (IUD) in WWE. We enrolled 20 women with well-controlled epilepsy and a stable antiepileptic drug (AED) regimen and who were initiating a progestin-containing IUD (levonorgestrel 52 mg) in a prospective, observational study. For each AED, we compared the trough concentration before IUD insertion to the trough concentration 3 weeks, and 3 and 6 months later. Participants recorded seizures in a daily paper diary. We compared seizures that occurred during the month before IUD insertion to those occurring in the 6 months thereafter. Participants completed an acceptability questionnaire at 3 and 6 months. Participants' average age was 28 years; 60% were nulligravid. They reported a history of multiple seizure types. During the baseline month, 75% were seizure-free and the remainder reported between one and three seizures. Fourteen received monotherapy and six received polytherapy. Lamotrigine use was most common (n = 12). AED trough concentrations remained stable during the 6 months after IUD insertion, without clinically meaningful deviations from baseline. Diary data showed that seizure frequency worsened in 3, and remained unchanged in 13 and improved in 4 after IUD insertion. Subjectively, no participant believed the IUD worsened her seizure control. All participants were either somewhat or very satisfied with the IUD throughout the study. All participants continued the IUD use at 6 months. No pregnancies occurred. This pilot study suggests that the progestin-containing IUD is a safe and acceptable long-acting contraceptive for WWE. Wiley Periodicals, Inc. © 2016 International League

  1. Nursing Students' Clinical Experience With Death: A Pilot Study.

    PubMed

    Heise, Barbara A; Gilpin, Laura C

    2016-01-01

    Although debriefing in simulation settings is routine in nursing education, debriefing does not routinely take place in clinical settings with nursing students after a patient has died. This pilot study sought to explore nursing students' perceptions of their first experience with the death of a patient. Students reported emotional distress and feelings of inadequacy with regard to communicating with and supporting the family of the dying patient. Only half the students sampled reported debriefing by their clinical instructor or staff. Nurse educators must include debriefing and student support following a patient death in the clinical setting.

  2. An internal pilot design for prospective cancer screening trials with unknown disease prevalence.

    PubMed

    Brinton, John T; Ringham, Brandy M; Glueck, Deborah H

    2015-10-13

    For studies that compare the diagnostic accuracy of two screening tests, the sample size depends on the prevalence of disease in the study population, and on the variance of the outcome. Both parameters may be unknown during the design stage, which makes finding an accurate sample size difficult. To solve this problem, we propose adapting an internal pilot design. In this adapted design, researchers will accrue some percentage of the planned sample size, then estimate both the disease prevalence and the variances of the screening tests. The updated estimates of the disease prevalence and variance are used to conduct a more accurate power and sample size calculation. We demonstrate that in large samples, the adapted internal pilot design produces no Type I inflation. For small samples (N less than 50), we introduce a novel adjustment of the critical value to control the Type I error rate. We apply the method to two proposed prospective cancer screening studies: 1) a small oral cancer screening study in individuals with Fanconi anemia and 2) a large oral cancer screening trial. Conducting an internal pilot study without adjusting the critical value can cause Type I error rate inflation in small samples, but not in large samples. An internal pilot approach usually achieves goal power and, for most studies with sample size greater than 50, requires no Type I error correction. Further, we have provided a flexible and accurate approach to bound Type I error below a goal level for studies with small sample size.

  3. Prospective assessment of stereoscopic visual status and USAF pilot training attrition.

    PubMed

    Snyder, Q C; Lezotte, D C

    1993-01-01

    The role of stereopsis (i.e., the use of binocular cues for depth perception) in military aviation is undetermined. Pilots possessing adequate near stereopsis but having deficient distant stereopsis are thought to have microtropias. Historical reviews of microtropia and research concerning the role of depth perception in military aviation are described. A historical prospective study of student pilots entering U.S. Air Force Undergraduate Pilot Training (UPT) from Oct 1990 through Sep 1991 (FY 90-91) compares UPT attrition rates according to their preselection stereoscopic status (microtropia vs. normal). Univariate and multiple logistic regression analyses do not show significant differences in attrition rates between the two groups, implying that distant stereopsis is not critical to successful completion of UPT. The U.S. Air Force decided in Oct 91 to eliminate near stereoscopic vision screening while retaining distant stereoacuity testing as a criterion for candidates to qualify medically for UPT. Valid rationale for this decision includes simplified and uniform administration of stereoacuity testing, minimizing spurious results, the continued validity of stereopsis testing as a cross-check of other areas of visual function, the uncertain role of stereopsis in critical areas of flight operations, and the large applicant pool competing for a limited number of pilot training positions.

  4. Prospects and strategies for clinical tolerance.

    PubMed

    Monaco, A P

    2004-01-01

    The morbidity and mortality associated with chronic immunosuppression provide a strong motivation for development of clinical tolerance. This paper discusses the definition(s) of clinical (operational) tolerance, the role of chimerism in experimental and clinical tolerance, and the special role of bone marrow in tolerance induction. The states of microchimerism and macrochimerism are defined and related to certain clinical observations in solid organ transplantation. Current clinical strategies already being tested in the clinic are briefly reviewed. Certain principles for induction of clinical (operational) tolerance are elaborated.

  5. Electronic brachytherapy for superficial and nodular basal cell carcinoma: a report of two prospective pilot trials using different doses

    PubMed Central

    Pons-Llanas, Olga; Candela-Juan, Cristian; Celada-Álvarez, Francisco Javier; Barker, Christopher A.; Tormo-Micó, Alejandro; Pérez-Calatayud, Jose; Botella-Estrada, Rafael

    2016-01-01

    Purpose Basal cell carcinoma (BCC) is a very common cancer in the Caucasian population. Treatment aims to eradicate the tumor with the lowest possible functional and aesthetic impact. Electronic brachytherapy (EBT) is a treatment technique currently emerging. This study aims to show the outcomes of two consecutive prospective pilot clinical trials using different radiation doses of EBT with Esteya® EB system for the treatment of superficial and nodular basal cell carcinoma. Material and methods Two prospective, single-center, non-randomized, pilot studies were conducted. Twenty patients were treated in each study with different doses. The first group (1) was treated with 36.6 Gy in 6 fractions of 6.1 Gy, and the second group (2) with 42 Gy in 6 fractions of 7 Gy. Cure rate, acute toxicity, and late toxicity related to cosmesis were analyzed in the two treatment groups. Results In group 1, a complete response in 90% of cases was observed at the first year of follow-up, whereas in group 2, the complete response was 95%. The differences with reference to acute toxicity and the cosmetic results between the two treatment groups were not statistically significant. Conclusions Our initial experience with Esteya® EB system to treat superficial and nodular BCC shows that a dose of 36.6 Gy and 42 Gy delivered in 6 fraction of 7 Gy achieves a 90% and 95% clinical cure rate at 1 year, respectively. Both groups had a tolerable toxicity and a very good cosmesis. The role of EBT in the treatment of BCC is still to be defined. It will probably become an established option for selected patients in the near future. PMID:26985197

  6. The Effect of Prospective Monitoring and Early Physiotherapy Intervention on Arm Morbidity Following Surgery for Breast Cancer: A Pilot Study

    PubMed Central

    Singh, Chiara; De Vera, Mary

    2013-01-01

    ABSTRACT Purpose: Significant arm morbidity is reported following surgery for breast cancer, yet physiotherapy is not commonly part of usual care. This study compared the effect on arm morbidity after surgery for breast cancer of a clinical care pathway including preoperative education, prospective monitoring, and early physiotherapy (experimental group) to that of preoperative education alone (comparison group). Methods: A prospective quasi-experimental pretest–posttest, non-equivalent group design compared two clinical sites; Site A (n=41) received the experimental intervention, and Site B (n=31) received the comparison intervention. At baseline (preoperative) and 7 months postoperative, shoulder range of motion (ROM), upper-extremity (UE) strength, UE circumference, pain, UE function, and quality of life were assessed. Results: The experimental group maintained shoulder flexion ROM at 7 months, whereas the comparison group saw a decrease (mean 1° [SD 9°] vs. −6° [SD 15°], p=0.03). A lower incidence of arm morbidity and better quality of life were observed in the experimental group, but these findings were not statistically significant. Baseline characteristics and surgical approaches differed between the two sites, which may have had an impact on the findings. Conclusion: Initial results are promising and support the feasibility of integrating a surveillance approach into follow-up care. This pilot study provides the foundation for a larger, more definitive trial. PMID:24403683

  7. A prospective pilot study of B2A-coated ceramic granules (Amplex) compared to autograft for ankle and hindfoot arthrodesis.

    PubMed

    Glazebrook, Mark; Younger, Alastair; Wing, Kevin; Lalonde, Karl-Andre

    2013-08-01

    To reduce fusion nonunion, autogenous bone graft is often incorporated into foot and ankle fusion procedures. B2A peptide-coated ceramic granules, with encouraging results in pilot studies of transforaminal lumbar interbody fusion, were here reformulated into Amplex with a coating concentration of 225 μg B2A/cm(3) ceramic granules (B2A-granule) with the goal of eliminating autogenous bone graft in foot and ankle arthrodesis. The purpose of this study was to perform a multicenter prospective randomized pilot clinical trial designed to compare the safety and effectiveness of B2A-granule to autogenous bone graft in patients undergoing foot and ankle arthrodesis surgery. This study was a multicenter, prospective, randomized, pilot clinical trial designed to compare safety and effectiveness of B2A-granule to autogenous bone graft in patients undergoing foot and ankle arthrodesis surgery. Twenty-four patients were enrolled and randomized (1:1) into 2 groups: autogenous bone graft control and B2A-granule. Primary outcome measures at 6 months (with follow-up at 9 and 12 months) included radiographic fusion assessed by computerized tomography and Ankle Osteoarthritis Scale scores for pain and disability. Radiographic fusion success rates were similar in both groups (100% in the B2A-granule group, 92% autograft). Both the B2A-granule group and the autograft group had improvements in the pain and disability scores over the course of the study. Graft harvest-site pain affected only autograft-treated patients. There were no adverse events attributed to the graft material in either the B2A-granule or autograft group. The results of this pilot study are supportive of a larger clinical trial to assess the safety and efficacy of B2A-granule as a bone graft substitute in foot and ankle fusions. Level II, prospective comparative study.

  8. Prospective, randomized, single blinded pilot study of a new FlatWire based sternal closure system

    PubMed Central

    2014-01-01

    Background Unstable steel wire cerclage following open heart surgery may result in increased pain, sternal cut-through, non-union, or dehiscence. These complications lead to longer hospital stays, increased cost, higher morbidity, and patient dissatisfaction. The Figure 8 FlatWire Sternal Closure System is a new construct which is a simple, intuitive, and inexpensive alternative for primary sternal repair following open heart surgery. Prior bench-top testing of FlatWire has demonstrated superior strength and stiffness compared to traditional steel wire. We present our initial experience in a prospective, randomized, single blinded pilot study utilizing this FDA approved system. Methods Sixty-three patients undergoing elective complete sternotomies at a single institution were randomly assigned to receive either the Figure 8 FlatWire or standard steel wire cerclage. All surgeries were performed by a single board certified cardiothoracic surgeon. Data collected included: Age, BMI, pump time, off pump to surgical stop time, length of hospital stay after surgery, cost from time of surgery to discharge, and pain on a visual analog pain scale on the day of discharge, day 30, and day 60. Results The groups were well matched. Patients receiving the Figure 8 FlatWire (33) had a reduction in length of stay compared to patients receiving steel wire circlage (30), but it was not statistically significant (6.8 vs. 7.8 days respectively, p < 0.093). Additionally those with the FlatWire reported significantly decreased pain at day of discharge (3.07 vs. 4.92 points on pain scale, p < 0.0066), with similar pain scores at 30 and 60 days. Off pump to surgery stop time was increased by 15.9 minutes in patients receiving the FlatWire vs. steel wires (55.7 vs. 71.6 minutes, p = 0.00025). Mean cost from surgery until discharge was $87,820.98 in the FlatWire group vs. $91,930.29 in the steel wire group (p < 0.3082). Conclusion Early clinical results suggest that

  9. Overcoming the tyranny of distance: An audit of process and outcomes from a pilot telehealth spinal assessment clinic.

    PubMed

    Beard, Matthew; Orlando, Joseph F; Kumar, Saravana

    2017-09-01

    Introduction There is consistent evidence to indicate people living in rural and remote regions have limited access to healthcare and poorer health outcomes. One way to address this inequity is through innovative models of care such as telehealth. The aim of this pilot trial was to determine the feasibility, appropriateness and access to a telehealth clinic. In this pilot trial, the telehealth clinic outcomes are compared with the outreach clinic. Both models of care are commonly utilised means of providing healthcare to meet the needs of people living in rural and remote regions. Methods A prospective audit was conducted on a Spinal Assessment Clinic Telehealth pilot trial for patients with spinal disorders requiring non-urgent surgical consultation. Data were recorded from all consultations managed using videoconferencing technology between the Royal Adelaide Hospital and Port Augusta Community Health Service, South Australia between September 2013 and January 2014. Outcomes included analysis of process, service activity, clinical actions, safety and costs. Data were compared to a previous spinal assessment outreach clinic in the same area between August and December 2012. Results There were 25 consultations with 22 patients over the five-month telehealth pilot trial. Spinal disorders were predominantly of the lumbar region (88%); the majority of initial consultations (64%) were discharged to the general practitioner. There were three requests for further imaging, five for minor interventions and three for other specialist/surgical consultation. Patient follow-up post telehealth pilot trial revealed no adverse outcomes. The total cost of AUD$11,187 demonstrated a 23% reduction in favour of the spinal assessment telehealth pilot trial, with the greatest savings in travel costs. Discussion The telehealth model of care demonstrated the efficient management of patients with spinal disorders in rural regions requiring non-urgent surgical consultation at low costs with

  10. Enhancing Patient Safety Using Clinical Nursing Data: A Pilot Study.

    PubMed

    Choi, Jeeyae; Choi, Jeungok E

    2016-01-01

    To enhance patient safety from falls, many hospital information systems have been implemented to collect clinical data from the bedside and have used the information to improve fall prevention care. However, most of them use administrative data not clinical nursing data. This necessitated the development of a web-based Nursing Practice and Research Information Management System (NPRIMS) that processes clinical nursing data to measure nurses' delivery of fall prevention care and its impact on patient outcomes. This pilot study developed computer algorithms based on a falls prevention protocol and programmed the prototype NPRIMS. It successfully measured the performance of nursing care delivered and its impact on patient outcomes using clinical nursing data from the study site. Results of the study revealed that NPRIMS has the potential to pinpoint components of nursing processes that are in need of improvement for preventing patient from falls.

  11. Prospective pilot trial of PerMIT versus standard anticoagulation service management of patients initiating oral anticoagulation.

    PubMed

    Borgman, Mark P; Pendleton, Robert C; McMillin, Gwendolyn A; Reynolds, Kristen K; Vazquez, Sara; Freeman, Andrew; Wilson, Andrew; Valdes, Roland; Linder, Mark W

    2012-09-01

    We performed a randomised pilot trial of PerMIT, a novel decision support tool for genotype-based warfarin initiation and maintenance dosing, to assess its efficacy for improving warfarin management. We prospectively studied 26 subjects to compare PerMIT-guided management with routine anticoagulation service management. CYP2C9 and VKORC1 genotype results for 13 subjects randomly assigned to the PerMIT arm were recorded within 24 hours of enrolment. To aid in INR interpretation, PerMIT calculates estimated loading and maintenance doses based on a patient's genetic and clinical characteristics and displays calculated S-warfarin plasma concentrations based on planned or administered dosages. In comparison to control subjects, patients in the PerMIT study arm demonstrated a 3.6-day decrease in the time to reach a stabilised INR within the target therapeutic range (4.7 vs. 8.3 days, p = 0.015); a 12.8% increase in time spent within the therapeutic interval over the first 25 days of therapy (64.3% vs. 55.3%, p = 0.180); and a 32.9% decrease in the frequency of warfarin dose adjustments per INR measurement (38.3% vs. 57.1%, p = 0.007). Serial measurements of plasma S-warfarin concentrations were also obtained to prospectively evaluate the accuracy of the pharmacokinetic model during induction therapy. The PerMIT S-warfarin plasma concentration model estimated 62.8% of concentrations within 0.15 mg/l. These pilot data suggest that the PerMIT method and its incorporation of genotype/phenotype information may help practitioners increase the safety, efficacy, and efficiency of warfarin therapeutic management.

  12. Integrating service excellence in a CHF clinical pathway pilot project.

    PubMed

    Hahn, Joyce; Bishop, Geri; Fennell, Lenora

    2002-01-01

    The complex dynamics of the current healthcare environment require healthcare delivery systems to become cost effective and quality driven. Educated healthcare consumers expect superior service and timely responses to their needs. For one healthcare system, customer expectations were an integral part of designing, implementing, and measuring the service components of congestive heart failure pathway outcomes. Service excellence can influence overall clinical outcomes when measured by consumer awareness and patient satisfaction. The inclusion of service excellence as an intrinsic piece of the organizational strategic plan laid the groundwork for this integrated pilot project.

  13. Piloting Augmented Reality Technology to Enhance Realism in Clinical Simulation.

    PubMed

    Vaughn, Jacqueline; Lister, Michael; Shaw, Ryan J

    2016-09-01

    We describe a pilot study that incorporated an innovative hybrid simulation designed to increase the perception of realism in a high-fidelity simulation. Prelicensure students (N = 12) cared for a manikin in a simulation lab scenario wearing Google Glass, a wearable head device that projected video into the students' field of vision. Students reported that the simulation gave them confidence that they were developing skills and knowledge to perform necessary tasks in a clinical setting and that they met the learning objectives of the simulation. The video combined visual images and cues seen in a real patient and created a sense of realism the manikin alone could not provide.

  14. Clinical Linguistics--Retrospect and Prospect.

    ERIC Educational Resources Information Center

    Grunwell, Pamela

    In the past 20 years, linguistics has gained a prominent position in speech and language pathology in Britain, evolving into a new field, clinical linguistics. It includes three related areas of activity: training of speech pathologists/therapists; professional practice; and research. Linguistics and speech/language pathology have developed as…

  15. Evaluation of 5 versus 10 granulocyteaphaeresis sessions in steroid-dependent ulcerative colitis: A pilot, prospective, multicenter, randomized study

    PubMed Central

    Ricart, Elena; Esteve, Maria; Andreu, Montserrat; Casellas, Francesc; Monfort, David; Sans, Miquel; Oudovenko, Natalia; Lafuente, Raúl; Panés, Julián

    2007-01-01

    AIM: To evaluate the efficacy of 5 compared to 10 granulocyteaphaeresis sessions in patients with active steroid-dependent ulcerative colitis. METHODS: In this pilot, prospective, multicenter randomized trial, 20 patients with moderately active steroid-dependent ulcerative colitis were randomized to 5 or 10 granulocyteaphaeresis sessions. The primary objective was clinical remission at wk 17. Secondary measures included endoscopic remission and steroid consumption. RESULTS: Nine patients were randomized to 5 granulocyteaphaeresis sessions (group 1) and 11 patients to 10 granulocyteaphaeresis sessions (group 2). At wk 17, 37.5% of patients in group 1 and 45.45% of patients in group 2 were in clinical remission. Clinical remission was accompanied by endoscopic remission in all cases. Eighty-six percent of patients achieving remission were steroid-free at wk 17. Daily steroid requirements were significantly lower in group 2. Eighty-nine per cent of patients remained in remission during a one year follow-up. One serious adverse event, not related to the study therapy, was reported. CONCLUSION: Granulocyteaphaeresis is safe and effective for the treatment of steroid-dependent ulcerative colitis. In this population, increasing the number of aphaeresis sessions is not associated with higher remission rates, but affords a significant steroid-sparing effect. PMID:17465500

  16. [Clinical nursing manpower: development and future prospects].

    PubMed

    Lin, Chiou-Fen; Kao, Ching-Chiu

    2014-04-01

    The significant changes in nursing manpower utilization in Taiwan over the past two decades are due in large part to the implementation of the National Health Insurance program and the rising need for long-term care. The changes have impacted clinical nursing manpower utilization in two important ways. Firstly, there has been a substantial increase in overall demand for nursing manpower. In particular, the need for clinical nurses has nearly quadrupled during this time period. Secondly, the level of difficulty involved in patient care has risen dramatically, with factors including increased disease severity and increased care quality expectations, among others. These changes, coupled with demands on nursing manpower imposed from other sectors, underpin and further exacerbate the problem of nursing manpower shortages throughout the healthcare system. To raise the quality of the nursing work environment, the Ministry of Health and Welfare (MOHW) brought together Taiwan's key professional nursing organizations to promote 10 care-reform strategies, establish the nursing-aid manpower system, and create the nursing classification system as an approach to effectively attract nurses to take positions in the medical system.

  17. Patient participation in cancer clinical trials: A pilot test of lay navigation

    PubMed Central

    Cartmell, Kathleen B.; Bonilha, Heather S.; Matson, Terri; Bryant, Debbie C.; Zapka, Jane G.; Bentz, Tricia A.; Ford, Marvella E.; Hughes-Halbert, Chanita; Simpson, Kit N.; Alberg, Anthony J.

    2016-01-01

    Background Clinical trials (CT) represent an important treatment option for cancer patients. Unfortunately, patients face challenges to enrolling in CTs, such as logistical barriers, poor CT understanding and complex clinical regimens. Patient navigation is a strategy that may help to improve the delivery of CT education and support services. We examined the feasibility and initial effect of one navigation strategy, use of lay navigators. Methods A lay CT navigation intervention was evaluated in a prospective cohort study among 40 lung and esophageal cancer patients. The intervention was delivered by a trained lay navigator who viewed a 17-minute CT educational video with each patient, assessed and answered their questions about CT participation and addressed reported barriers to care and trial participation. Results During this 12-month pilot project, 85% (95% CI: 72%-93%) of patients eligible for a therapeutic CT consented to participate in the CT navigation intervention. Among navigated patients, CT understanding improved between pre- and post-test (means 3.54 and 4.40, respectively; p-value 0.004), and 95% (95% CI: 82%-98%) of navigated patients consented to participate in a CT. Navigated patients reported being satisfied with patient navigation services and CT participation. Conclusions In this formative single-arm pilot project, initial evidence was found for the potential effect of a lay navigation intervention on CT understanding and enrollment. A randomized controlled trial is needed to examine the efficacy of the intervention for improving CT education and enrollment. PMID:27822566

  18. Prospects of Nanotechnology in Clinical Immunodiagnostics

    PubMed Central

    Ansari, Anees A.; Alhoshan, Mansour; Alsalhi, Mohamad S.; Aldwayyan, Abdullah S.

    2010-01-01

    Nanostructured materials are promising compounds that offer new opportunities as sensing platforms for the detection of biomolecules. Having micrometer-scale length and nanometer-scale diameters, nanomaterials can be manipulated with current nanofabrication methods, as well as self-assembly techniques, to fabricate nanoscale bio-sensing devices. Nanostructured materials possess extraordinary physical, mechanical, electrical, thermal and multifunctional properties. Such unique properties advocate their use as biomimetic membranes to immobilize and modify biomolecules on the surface of nanoparticles. Alignment, uniform dispersion, selective growth and diameter control are general parameters which play critical roles in the successful integration of nanostructures for the fabrication of bioelectronic sensing devices. In this review, we focus on different types and aspects of nanomaterials, including their synthesis, properties, conjugation with biomolecules and their application in the construction of immunosensing devices. Some key results from each cited article are summarized by relating the concept and mechanism behind each sensor, experimental conditions and the behavior of the sensor under different conditions, etc. The variety of nanomaterial-based bioelectronic devices exhibiting novel functions proves the unique properties of nanomaterials in such sensing devices, which will surely continue to expand in the future. Such nanomaterial based devices are expected to have a major impact in clinical immunodiagnostics, environmental monitoring, security surveillance and for ensuring food safety. PMID:22163566

  19. Is alcohol required for effective pancreatic cyst ablation? The prospective randomized CHARM trial pilot study

    PubMed Central

    Moyer, Matthew T.; Dye, Charles E.; Sharzehi, Setareh; Ancrile, Brooke; Mathew, Abraham; McGarrity, Thomas J.; Gusani, Niraj; Yee, Nelson; Wong, Joyce; Levenick, John; Dougherty-Hamod, Brandy; Mathers, Bradley

    2016-01-01

    Background and study aims: In this study, we aim to determine the safety and feasibility of an alcohol-free approach to pancreatic cyst ablation using a chemotherapeutic ablation cocktail. Patients and methods: In this prospective, randomized, double-blinded pilot study, 10 patients with known mucinous type pancreatic cysts underwent endoscopic ultrasound (EUS)-guided fine needle aspiration and then lavage with either 80 % ethanol or normal saline. Both groups were then treated with a cocktail of paclitaxel and gemcitabine. Primary outcomes were reduction in cyst volume and rates of complications. Results: At 6 months, patients randomized to the alcohol arm had an 89 % average volume reduction, with a 91 % reduction noted in the alcohol-free arm. Complete ablation was achieved in 67 % of patients in the alcohol-free arm at both 6 and 12 months, whereas the alcohol group recorded complete ablation rates of 50 % and 75 % at 6 and 12 months, respectively. One patient in the alcohol arm developed acute pancreatitis (20 %) with no adverse events in the alcohol-free arm. Conclusions: This study revealed similar ablation rates between the alcohol ablation group and the alcohol-free arm and demonstrates the safety and feasibility of an alcohol-free ablation protocol. This pilot study suggests that alcohol may not be required for effective cyst ablation. PMID:27227122

  20. PTSD elderly war veterans: a clinical controlled pilot study.

    PubMed

    Gamito, Pedro; Oliveira, Jorge; Rosa, Pedro; Morais, Diogo; Duarte, Nuno; Oliveira, Susana; Saraiva, Tomaz

    2010-02-01

    Around 25,000 war veterans in Portugal suffer posttraumatic stress disorder (PTSD). This clinically controlled study evaluates virtual reality exposure therapy (VRET) as an alternative procedure to reduce PTSD symptoms. Ten patients were assigned to three groups: VRET, exposure in imagination (EI), and waiting list (WL). The patients were Portuguese veterans from a series of wars fought in former African colonies more than 30 years ago. While the EI group participated in traditional imagination therapy, the VRET group was exposed to a virtual reality (VR) war scenario. Cues such as ambush, mortar blasting, and waiting for rescue were used in the VR. Patients enrolled in the VRET group showed statistical reduction of PTSD-associated disorders like depression and anxiety. Far from being conclusive, this pilot study nonetheless presents some promising data on the use of VRET on old war veteran populations.

  1. Where have all the pilot studies gone? A follow-up on 30 years of pilot studies in Clinical Rehabilitation.

    PubMed

    Kaur, Navaldeep; Figueiredo, Sabrina; Bouchard, Vanessa; Moriello, Carolina; Mayo, Nancy

    2017-09-01

    Pilot studies are meritorious for determining the feasibility of a definitive clinical trial in terms of conduct and potential for efficacy, but their possible applications for planning a future trial are not always fully realized. The purpose of this review was to estimate the extent to which pilot/feasibility studies: (i) addressed needed objectives; (ii) led to definitive trials; and (iii) whether the subsequent undertaking of a definitive trial was influenced by the strength of the evidence of outcome improvement. Trials published in the journal Clinical Rehabilitation, since its inception, were eligible if the word 'pilot' or 'feasibility' was specified somewhere in the article. A total of 191 studies were reviewed, results were summarized descriptively, and between-group effect sizes were computed. The specific purposes of piloting were stated in only 58% ( n = 110) of the studies. The most frequent purpose was to estimate the potential for efficacy (85%), followed by testing the feasibility of the intervention (60%). Only 12% of the studies were followed by a definitive trial; <4% of studies had a main study underway or a published study protocol. There was no relationship between observed effect size and follow-up of pilot studies, although the confidence intervals were very wide owing to small number of trials that followed on. Labelling and reporting of pilot studies needs to be improved to be concordant with the recently issued CONSORT guidelines. Feasibility needs to be fully tested and demonstrated prior to committing considerable human and monetary resources.

  2. Clinical evidence for Japanese population based on prospective studies--linking clinical trials and clinical practice.

    PubMed

    Ogawa, Hisao; Kojima, Sunao

    2009-10-01

    "Evidence-based medicine (EBM)" implies effective and high quality practice for patients based on well-grounded medical science. The success of clinical trials in Japan is essential to build original evidence specific for Japanese patients. Based on this concept, we have performed several large-scale clinical trials to provide EBM, including the Japanese Antiplatelets Myocardial Infarction Study [JAMIS; clinical improvement in acute myocardial infarction (AMI) patients with antiplatelet therapy], the Japanese beta-Blockers and Calcium Antagonists Myocardial Infarction (JBCMI; comparison of the effects of beta-blockers and calcium antagonists on cardiovascular events in post-AMI patients), a multicenter study for aggressive lipid-lowering strategy by HMG-CoA reductase inhibitors in patients with AMI (MUSASHI; effects of statin therapy on cardiovascular events in patients with AMI), and the Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD trial; efficacy of low-dose aspirin therapy for primary prevention of atherosclerotic events in type 2 diabetic patients). The results of these prospective studies were directly linked with clinical practice. We have acquired the know-how of large-scale clinical trials; an important point is to have passion for "buildup evidence specific for the Japanese" and to recruit subjects for enrollment after explaining the significance of "clinical trials for the Japanese".

  3. Efficacy and safety of oral alitretinoin in severe oral lichen planus--results of a prospective pilot study.

    PubMed

    Kunz, M; Urosevic-Maiwald, M; Goldinger, S M; Frauchiger, A L; Dreier, J; Belloni, B; Mangana, J; Jenni, D; Dippel, M; Cozzio, A; Guenova, E; Kamarachev, J; French, L E; Dummer, R

    2016-02-01

    Patients with severe oral lichen planus refractory to standard topical treatment currently have limited options of therapy suitable for long-term use. Oral alitretinoin (9-cis retinoic acid) was never systematically investigated in clinical trials, although case reports suggest its possible efficacy. To assess the efficacy and safety of oral alitretinoin taken at 30 mg once daily for up to 24 weeks in the treatment of severe oral lichen planus refractory to standard topical therapy. We conducted a prospective open-label single arm pilot study to test the efficacy and safety of 30 mg oral alitretinoin once daily for up to 24 weeks in severe oral lichen planus. Ten patients were included in the study. Primary end point was reduction in signs and symptoms measured by the Escudier severity score. Secondary parameters included pain and quality of life scores. Safety parameters were assessed during a follow-up period of 5 weeks. A substantial response at the end of treatment, i.e. >50% reduction in disease severity measured by the Escudier severity score, was apparent in 40% of patients. Therapy was well tolerated. Adverse events were mild and included headache, mucocutaneous dryness, musculoskeletal pain, increased thyroid-stimulating hormone and dyslipidaemia. Alitretinoin given at 30 mg daily reduced disease severity of severe oral lichen planus in a substantial proportion of patients refractory to standard treatment, was well tolerated and may thus represent one therapeutic option for this special group of patients. © 2015 European Academy of Dermatology and Venereology.

  4. A virtual clinic for diabetes self-management: pilot study.

    PubMed

    Jennings, Amy; Powell, John; Armstrong, Natalie; Sturt, Jackie; Dale, Jeremy

    2009-03-30

    Internet-based interventions to assist in diabetes management have the potential to provide patients with the information and support they need to become effective self-managers. To assess the feasibility, acceptability, and effectiveness of an Internet-based virtual clinic designed to facilitate self-management in patients who used insulin pumps to manage their diabetes. For a period of 6 months, 17 patients joined the virtual clinic. The system allowed patients to communicate with health professionals, interact with peers and access information. HbA1c, quality of life, and self-efficacy were monitored at baseline and after 6 months. Questionnaires and qualitative interviews examined patient experiences. Participants found the virtual clinic easy to use and positively rated its design. Peer support was the most valued aspect and the discussion boards the most used component. All participants highly rated the virtual clinic in terms of improving communication with peers, but few agreed it had improved communication with health care professionals. No significant improvements in physiological and psychological measurements were found. Regarding HbA1c measurements, there was no significant difference found between the pre- and post-test results (P = .53). Mean ADDQoL scores at baseline were -2.1 (SD 1.1, range -3.4 to -0.5) compared to -2.0 (SD 1.2, range, -4.6 to -0.4) post-test (n = 12), (P = .62). Surprisingly, patients' confidence in their ability to perform self-care tasks was found to be significantly reduced from baseline to follow up (P = .045). An Internet-based system to aid the management of diabetes appears feasible and well accepted by patients. The pilot study did not identify evidence of an impact on improving quality of life or self-efficacy in patients who used insulin pump therapy.

  5. Does an education intervention improve physician signature legibility? Pilot study of a prospective chart review.

    PubMed

    Glisson, James K; Morton, Mary E; Bond, Allyn H; Griswold, Michael

    2011-01-01

    Illegible physician signatures in patient records can lead to inaccurate documentation, improper billing, and potential legal issues. Many studies in the current literature address legibility of prescriptions and medication orders; however, few focus on legibility of physicians' signatures. The purpose of the present quality improvement survey was to evaluate physician signature legibility on patient charts at the University of Mississippi Medical Center's Adult Internal Medicine Clinic. At the time of the study, the clinic was known as the University of Mississippi Medical Center (UMMC) Adult Internal Medicine Clinic. Effective July 1, 2009, UMMC entered into a collaboration with Jackson-Hinds Comprehensive Health Center (JHCHC), a federally qualified health center. The clinic is now known as the Federally Qualified Health Center at the Jackson Medical Mall. In this pilot study, we examined clinic notes and billing sheets for legible physician signatures over a three-month period. Midway through the study, an intervention group was given name stamps and a standardized discussion on the importance of signature legibility and proper name stamp usage. Legibility of resident signatures in the intervention group increased from 26 percent to 60 percent. Legibility of attending signatures in the intervention group increased from 1.4 percent to 86 percent. Results suggest the significant impact of resident education on changing practice behavior.

  6. Successful treatment of periungual warts with diluted bleomycin using translesional multipuncture technique: a pilot prospective study.

    PubMed

    AlGhamdi, Khalid M; Khurram, Huma

    2011-04-01

    The treatment of periungual warts is a therapeutic challenge. Various treatment modalities can be ineffective and may cause scarring and permanent nail changes. A prospective pilot study to investigate the efficacy and safety of a low concentration (0.1 U/mL) of bleomycin in the treatment of periungual warts. Periungual warts were injected with bleomycin (0.1 U/mL) every 4 weeks until elimination of the lesions or until the injections were discontinued because of adverse effects. Bleomycin was administered using the translesional multipuncture technique. We recruited 15 patients with periungual warts from March 2007 to March 2008. Thirteen patients were male (86.6%); median age was 30. Seven patients (46.6%) demonstrated complete clearance 1 month after the first injection; two required two treatment sessions. Thirteen (86.6%) patients had complete clearance of the treated wart at the 6-month follow-up with only one injection. Wart recurrence was observed in two patients. All patients were followed for 6 months after the initial treatment. No significant long-term adverse effects were noted. Only one patient demonstrated mild postinflammatory hyperpigmentation, which resolved after 1 month, and nine (60%) had localized moderate pain for 2 to 3 days after the injection. Translesional multipuncture treatment with a low concentration (0.1 U/mL) of bleomycin is an effective modality for periungual warts that results in minimal side effects. Larger controlled studies are needed. © 2011 by the American Society for Dermatologic Surgery, Inc.

  7. Asenapine for the Control of Physical Aggression: A Prospective Naturalist Pilot Study

    PubMed Central

    Amon, Jin Shi; Johnson, Sarah B.; El-Mallakh, Rif S.

    2017-01-01

    It has been previously purported that higher relative affinity to the dopamine D4 receptor compared to D2 (i.e., D4/D2 affinity ratio > 1) may underlie unique antiaggression potency. Asenapine is a newer antipsychotic that also has D4/D2 affinity ratio > 1. It has demonstrated efficacy in reducing acute agitation in a placebo-controlled study. We performed a prospective naturalistic, pilot, proof of concept study on an inpatient psychiatric unit. Among patients with aggression at time of admission (≥ 12 on Refined Aggression Questionnaire [RAQ], or ≥ 2 on Modified Overt Aggression Scale [MOAS]), asenapine treatment was associated with a significant reduction in total aggression as measured by the MOAS (−14.7 ± 11.59 vs. −5.4 ± 10.12, P = 0.045), and particularly physical aggression (−8.0 ± 5.06 vs. −0.78 ± 2.40, P < 0.0001) compared to treatment that did not include asenapine. These data suggest that asenapine may be useful in the targeted treatment of aggression, and provide some support for the D4/D2 affinity ratio hypothesis. PMID:28138201

  8. Proteomic analysis of field cancerization in pharynx and oesophagus: a prospective pilot study.

    PubMed

    Roesch-Ely, Mariana; Leipold, Alexandra; Nees, Matthias; Holzinger, Dana; Dietz, Andreas; Flechtenmacher, Christa; Wolf, Thomas; Zapatka, Marc; Bosch, Franz X

    2010-08-01

    'Field cancerization' in head and neck squamous cell carcinoma (HNSCC) is poorly understood and it may extend from the pharynx into the oesophagus. Both local recurrences and second primary carcinomas/second field tumours may originate from field cancerization. Our prospective pilot study aimed at the identification of patients suffering from field cancerization on the basis of mucosal protein profiles. Five mucosal biopsies from the oropharynx, hypopharynx and from three regions of the oesophagus were taken from 24 patients. Protein profiles were generated from the mucosal biopsies. After classifier learning, using the profiles of the patients without tumour diagnosis (n = 9), we were able to discriminate between the different mucosal sites and between healthy mucosa and HNSCC using tumour and healthy tissue samples. Mucosal biopsies of tumour patients (n = 15) revealed changes in the protein profiles similar to those in the tumours. During 42 months median follow-up, six tumour patients experienced local recurrences and second field tumours, of which three occurred in the oesophagus. In all six cases, tumour relapse was correctly predicted by altered mucosal protein profiles (p = 0.007, Fisher's exact test, two-tailed). Consequently, molecular field cancerization had a strong impact on progression-free survival (p = 0.007, log-rank test). Protein profiles of small diagnostic biopsies hold great promise to improve personalized risk assessment in HNSCC. Larger studies are needed to further substantiate these findings.

  9. [Study and prospects for clinical diseases treated with scraping therapy].

    PubMed

    Wang, Ying-ying; Yang, Jin-sheng

    2009-02-01

    In order to explore characteristics of clinical diseases treated by scraping therapy, summarize laws of clinical application of scraping therapy, and prospect for research direction of scraping therapy in future, collect 437 articles about scraping therapy between 1994-2007 and analyze and summarize the treated diseases and methods of scraping therapy. Results indicate that scraping therapy has been widely applied to commonly encountered diseases and frequently encountered diseases in departments of internal medicine, surgery, gynecology and pediatrics, etc. with more obvious therapeutic effects. Clinically, it can combine with acupuncture and moxibustion, cupping, massage, blood-letting puncture and other methods. In future, the studies on standardization of manipulation and standards for assessment of therapeutic effect, suitable diseases and the mechanisms of scraping therapy, and development of tools and media, etc. of scraping therapy should be strengthened.

  10. Adherence of Irish general practitioners to European guidelines for acute low back pain: a prospective pilot study.

    PubMed

    Fullen, Brona M; Maher, Thomas; Bury, Gerard; Tynan, Aodan; Daly, Leslie E; Hurley, Deirdre A

    2007-08-01

    There are no national low back pain (LBP) clinical guidelines in Ireland, and neither the level of adherence of General Practitioners (GPs) to the European guidelines, nor the cost of LBP to the patient and the state, have been investigated. A prospective pilot study was conducted on 54 consenting patients (18M, 36F: mean age (SD): 40.5 (14.3) years) with a new episode of acute LBP (<3 months) attending one of nine participating GPs. Baseline demographic, LBP classification [i.e. simple back ache (SBA), nerve root pain (NRP), serious spinal pathology (SSP)] and primary care management data were recorded over a three month period. Adherence and costs were estimated based on: medication prescription, referral for investigations, treatment or consultations, and wage replacement costs (time signed off work). For both SBA and NRP, medication prescriptions were consistent with European guideline recommendations, but not for referral for further treatment (39% of SBA patients were referred on first visit), secondary care (54% of NRP patients were referred on first visit), or discontinuation of work (50% NRP patients on first GP visit). The average total cost (direct and wage replacement) for a single episode of LBP over 12 weeks was 20,531 Euros (20,300-20,762). Direct costs accounted for 43% [8874.36 Euros, (8643.37-9105.37 Euros)] and wage replacement costs 57% (11,657 Euros). In conclusion, management of acute LBP in a cohort of GPs in Ireland was not consistent with European clinical guideline recommendations, and warrants higher levels of postgraduate education among GPs, as well as restructuring of primary care services, which should improve patient outcome and reduce costs.

  11. Prioritization strategies in clinical practice guidelines development: a pilot study

    PubMed Central

    2010-01-01

    Objective Few methodological studies address the prioritization of clinical topics for the development of Clinical Practice Guidelines (CPGs). The aim of this study was to validate a methodology for Priority Determination of Topics (PDT) of CPGs. Methods and results Firstly, we developed an instrument for PDT with 41 criteria that were grouped under 10 domains, based on a comprehensive systematic search. Secondly, we performed a survey of stakeholders involved in CPGs development, and end users of guidelines, using the instrument. Thirdly, a pilot testing of the PDT procedure was performed in order to choose 10 guideline topics among 34 proposed projects; using a multi-criteria analysis approach, we validated a mechanism that followed five stages: determination of the composition of groups, item/domain scoring, weights determination, quality of the information used to support judgments, and finally, topic selection. Participants first scored the importance of each domain, after which four different weighting procedures were calculated (including the survey results). The process of weighting was determined by correlating the data between them. We also reported the quality of evidence used for PDT. Finally, we provided a qualitative analysis of the process. The main domains used to support judgement, having higher quality scores and weightings, were feasibility, disease burden, implementation and information needs. Other important domains such as user preferences, adverse events, potential for health promotion, social effects, and economic impact had lower relevance for clinicians. Criteria for prioritization were mainly judged through professional experience, while good quality information was only used in 15% of cases. Conclusion The main advantages of the proposed methodology are supported by the use of a systematic approach to identify, score and weight guideline topics selection, limiting or exposing the influence of personal biases. However, the methodology was

  12. Building sustainable multi-functional prospective electronic clinical data systems.

    PubMed

    Randhawa, Gurvaneet S; Slutsky, Jean R

    2012-07-01

    A better alignment in the goals of the biomedical research enterprise and the health care delivery system can help fill the large gaps in our knowledge of the impact of clinical interventions on patient outcomes in the real world. There are several initiatives underway to align the research priorities of patients, providers, researchers, and policy makers. These include Agency for Healthcare Research and Quality (AHRQ)-supported projects to build flexible prospective clinical electronic data infrastructure that meet the needs of these diverse users. AHRQ has previously supported the creation of 2 distributed research networks as a new approach to conduct comparative effectiveness research (CER) while protecting a patient's confidential information and the proprietary needs of a clinical organization. It has applied its experience in building these networks in directing the American Recovery and Reinvestment Act funds for CER to support new clinical electronic infrastructure projects that can be used for several purposes including CER, quality improvement, clinical decision support, and disease surveillance. In addition, AHRQ has funded a new Electronic Data Methods forum to advance the methods in clinical informatics, research analytics, and governance by actively engaging investigators from the American Recovery and Reinvestment Act-funded projects and external stakeholders.

  13. A Prospective Pilot Trial for Pallidal Deep Brain Stimulation in Huntington's Disease.

    PubMed

    Wojtecki, Lars; Groiss, Stefan J; Ferrea, Stefano; Elben, Saskia; Hartmann, Christian J; Dunnett, Stephen B; Rosser, Anne; Saft, Carsten; Südmeyer, Martin; Ohmann, Christian; Schnitzler, Alfons; Vesper, Jan

    2015-01-01

    Movement disorders in Huntington's disease are often medically refractive. The aim of the trial was assessment of procedure safety of deep brain stimulation, equality of internal- and external-pallidal stimulation and efficacy followed-up for 6 months in a prospective pilot trial. In a controlled double-blind phase six patients (four chorea-dominant, two Westphal-variant) with predominant movement disorder were randomly assigned to either the sequence of 6-week internal- or 6-week external-pallidal stimulation, or vice versa, followed by further 3 months chronic pallidal stimulation at the target with best effect-side-effect ratio. Primary endpoints were changes in the Unified Huntington's Disease Rating Scale motor-score, chorea subscore, and total motor-score 4 (blinded-video ratings), comparing internal- versus external-pallidal stimulation, and 6 months versus baseline. Secondary endpoints assessed scores on dystonia, hypokinesia, cognition, mood, functionality/disability, and quality-of-life. Intention-to-treat analysis of all patients (n = 3 in each treatment sequence): Both targets were equal in terms of efficacy. Chorea subscores decreased significantly over 6 months (-5.3 (60.2%), p = 0.037). Effects on dystonia were not significant over the group due to it consisting of three responders (>50% improvement) and three non-responders. Westphal patients did not improve. Cognition was stable. Mood and some functionality/disability and quality-of-life scores improved significantly. Eight adverse events and two additional serious adverse events - mostly internal-pallidal stimulation-related - resolved without sequalae. No procedure-related complications occurred. Pallidal deep brain stimulation was demonstrated to be a safe treatment option for the reduction of chorea in Huntington's disease. Their effects on chorea and dystonia and on quality-of-life should be examined in larger controlled trials.

  14. Metronomic therapy with oral 6-mercaptopurine in elderly acute myeloid leukemia: A prospective pilot study

    PubMed Central

    Kapoor, Akhil; Beniwal, Surender Kumar; Kalwar, Ashok; Singhal, Mukesh Kumar; Nirban, Raj Kumar; Kumar, Harvindra Singh

    2016-01-01

    Introduction: Acute myeloid leukemia (AML) in elderly patients differs biologically from that in younger patients and is known to have unfavorable chromosomal rearrangements, higher resistance, and lower tolerance to chemotherapy. In such circumstances, instead of giving full-blown chemotherapy, palliative metronomic chemotherapy (MCT) could be a treatment option. Patients and Methods: We performed a prospective pilot study of old AML patients (age >60 years) not amenable to curative treatment. Thirty-two patients were enrolled into the study and were treated with daily oral 6-mercaptopurine 75 mg/m2. The following inclusion criteria were used: age >60 years, nonpromyelocytic AML, the absence of uncontrolled comorbidities, and patient not amenable to curative treatment. Overall survival (OS) was calculated using Kaplan–Meier method and Cox regression analysis were used to calculate the hazards ratio of significant factors. Results: The median age of the patients was 69 years (range: 61–86 years) with male: female ratio of 2.5:1. About 59.4% of patients had Eastern Cooperative Oncology Group performance status of 2 while rest had the status of 3. The median OS was 6 months (95% confidence interval [CI]: 4.4–7.6). Males had median OS of 7 months (95% CI: 5.4–8.6) versus females with OS of 3 months (95% CI: 1.5–4.4; P = 0.008). There was no survival difference on the basis of baseline hemoglobin or French-American-British class. There were no Grade 4 toxicities and no episode of febrile neutropenia. Conclusions: MCT with oral 6-mercaptopurine is an attractive treatment option in elderly AML patients who are not amenable to curative therapy with minimal toxicities. PMID:27275453

  15. Use of the SONET score to evaluate Urgent Care Center overcrowding: a prospective pilot study

    PubMed Central

    Wang, Hao; Robinson, Richard D; Cowden, Chad D; Gorman, Violet A; Cook, Christopher D; Gicheru, Eugene K; Schrader, Chet D; Jayswal, Rani D; Zenarosa, Nestor R

    2015-01-01

    Objectives To derive a tool to determine Urgent Care Center (UCC) crowding and investigate the association between different levels of UCC overcrowding and negative patient care outcomes. Design Prospective pilot study. Setting Single centre study in the USA. Participants 3565 patients who registered at UCC during the 21-day study period were included. Patients who had no overcrowding statuses estimated due to incomplete collection of operational variables at the time of registration were excluded in this study. 3139 patients were enrolled in the final data analysis. Primary and secondary outcome measures A crowding estimation tool (SONET: Severely overcrowded, Overcrowded and Not overcrowded Estimation Tool) was derived using the linear regression analysis. The average length of stay (LOS) in UCC patients and the number of left without being seen (LWBS) patients were calculated and compared under the three different levels of UCC crowding. Results Four independent operational variables could affect the UCC overcrowding score including the total number of patients, the number of results pending for patients, the number of patients in the waiting room and the longest time a patient was stationed in the waiting room. In addition, UCC overcrowding was associated with longer average LOS (not overcrowded: 133±76 min, overcrowded: 169±79 min, and severely overcrowded: 196±87 min, p<0.001) and an increased number of LWBS patients (not overcrowded: 0.28±0.69 patients, overcrowded: 0.64±0.98, and severely overcrowded: 1.00±0.97). Conclusions The overcrowding estimation tool (SONET) derived in this study might be used to determine different levels of crowding in a high volume UCC setting. It also showed that UCC overcrowding might be associated with negative patient care outcomes. PMID:25872940

  16. Lung Ultrasound Surface Wave Elastography: A Pilot Clinical Study.

    PubMed

    Zhang, Xiaoming; Osborn, Thomas; Zhou, Boran; Meixner, Duane; Kinnick, Randall R; Bartholmai, Brian; Greenleaf, James F; Kalra, Sanjay

    2017-09-01

    A lung ultrasound surface wave elastography (LUSWE) technique is developed to measure superficial lung tissue elastic properties. The purpose of this paper was to translate LUSWE into clinical studies for assessing patients with interstitial lung disease (ILD) and present the pilot data from lung measurements on 10 healthy subjects and 10 patients with ILD. ILD includes multiple lung disorders in which the lung tissue is distorted and stiffened by tissue fibrosis. Chest radiography and computed tomography are the most commonly used techniques for assessing lung disease, but they are associated with radiation and cannot directly measure lung elastic properties. LUSWE provides a noninvasive and nonionizing technique to measure the elastic properties of superficial lung tissue. LUSWE was used to measure regions of both lungs through six intercostal spaces for patients and healthy subjects. The data are presented as wave speed at 100, 150, and 200 Hz at the six intercostal spaces. As an example, the surface wave speeds are, respectively, 1.88 ± 0.11 m/s at 100 Hz, 2.74 ± 0.26 m/s at 150 Hz, and 3.62 ± 0.13 m/s at 200 Hz for a healthy subject in the upper right lung; this is in comparison to measurements from an ILD patient of 3.3 ± 0.37 m/s at 100 Hz, 4.38 ± 0.33 m/s at 150 Hz, and 5.24 ± 0.44 m/s at 200 Hz in the same lung space. Significant differences in wave speed between healthy subjects and ILD patients were found. LUSWE is a safe and noninvasive technique which may be useful for assessing ILD.

  17. A pilot prospective study on closed loop controlled ventilation and oxygenation in ventilated children during the weaning phase.

    PubMed

    Jouvet, Philippe; Eddington, Allen; Payen, Valérie; Bordessoule, Alice; Emeriaud, Guillaume; Gasco, Ricardo Lopez; Wysocki, Marc

    2012-05-16

    The present study is a pilot prospective safety evaluation of a new closed loop computerised protocol on ventilation and oxygenation in stable, spontaneously breathing children weighing more than 7 kg, during the weaning phase of mechanical ventilation. Mechanically ventilated children ready to start the weaning process were ventilated for five periods of 60 minutes in the following order: pressure support ventilation, adaptive support ventilation (ASV), ASV plus a ventilation controller (ASV-CO2), ASV-CO2 plus an oxygenation controller (ASV-CO2-O2) and pressure support ventilation again. Based on breath-by-breath analysis, the percentage of time with normal ventilation as defined by a respiratory rate between 10 and 40 breaths/minute, tidal volume > 5 ml/kg predicted body weight and end-tidal CO2 between 25 and 55 mmHg was determined. The number of manipulations and changes on the ventilator were also recorded. Fifteen children, median aged 45 months, were investigated. No adverse event and no premature protocol termination were reported. ASV-CO2 and ASV-CO2-O2 kept the patients within normal ventilation for, respectively, 94% (91 to 96%) and 94% (87 to 96%) of the time. The tidal volume, respiratory rate, peak inspiratory airway pressure and minute ventilation were equivalent for all modalities, although there were more automatic setting changes in ASV-CO2 and ASV-CO2-O2. Positive end-expiratory pressure modifications by ASV-CO2-O2 require further investigation. Over the short study period and in this specific population, ASV-CO2 and ASV-CO2-O2 were safe and kept the patient under normal ventilation most of the time. Further research is needed, especially for positive end-expiratory pressure modifications by ASV-CO2-O2. ClinicalTrials.gov: NCT01095406.

  18. Clinical patterns of primary stabbing headache: a single clinic-based prospective study.

    PubMed

    Kim, Dong Yeop; Lee, Mi Ji; Choi, Hyun Ah; Choi, Hanna; Chung, Chin-Sang

    2017-12-01

    The clinical features and disease courses of primary stabbing headache (PSH) are diverse. We aimed to identify distinct clinical patterns of PSH. We prospectively screened consecutive first-visit patients who presented with stabbing headache at the Samsung Medical Centre Headache Clinic from June 2015 to March 2016. Demographics, headache characteristics, and disease courses were prospectively evaluated. After discerning factors related to the chronicity at the time of presentation, clinical patterns were identified based on the frequency (daily vs. intermittent), clinical course (remitted or not), and total disease duration (<3 or >3 months). In the 65 patients with PSH included in this study, monophasic (n = 31), intermittent (n = 17), and chronic daily (n = 12) patterns were identified. The median disease durations were 9 days for monophasic PSH, 9 months for chronic daily PSH, and 2 years for intermittent PSH. The features of monophasic PSH were greater severity, single and side-locked locations, more attacks per day, daily occurrence, and good treatment response. Chronic daily PSH was associated with female predominance, longer-lasting stabs, and multiple or migrating locations on bilateral or alternating sides. The characteristics of intermittent PSH included female predominance and sporadic stabs with less intensity. Our study demonstrated distinct clinical patterns of PSH. In addition to help early recognition of disease, our findings suggest different pathophysiologic mechanisms. Future prospective studies are required to reveal the etiologies of these different PSH patterns and their optimal treatment strategies.

  19. Early Intervention Following Trauma May Mitigate Genetic Risk for PTSD in Civilians: A Pilot Prospective Emergency Department Study

    PubMed Central

    Rothbaum, Barbara O.; Kearns, Megan C.; Reiser, Emily; Davis, Jennifer S.; Kerley, Kimberly A.; Rothbaum, Alex O.; Mercer, Kristina B.; Price, Matthew; Houry, Debra; Ressler, Kerry J.

    2015-01-01

    intervention group, even after controlling for age, sex, race, education, income, and childhood trauma. Using logistic regression, the number of risk alleles was significantly associated with likelihood of PTSD diagnosis at week 12 (P < .05). Conclusions This pilot prospective study suggests that combined genetic variants may serve to predict those most at risk for developing PTSD following trauma. A psychotherapeutic intervention initiated in the emergency department within hours of the trauma may mitigate this risk. The role of genetic predictors of risk and resilience should be further evaluated in larger, prospective intervention and prevention trials. Trial Registration ClinicalTrials.gov identifier: NCT00895518 PMID:25188543

  20. Adaptive Radiotherapy for Head-and-Neck Cancer: Initial Clinical Outcomes From a Prospective Trial

    SciTech Connect

    Schwartz, David L.; Garden, Adam S.; Thomas, Jimmy; Chen Yipei; Zhang Yongbin; Lewin, Jan; Chambers, Mark S.; Dong, Lei

    2012-07-01

    Purpose: To present pilot toxicity and survival outcomes for a prospective trial investigating adaptive radiotherapy (ART) for oropharyngeal squamous cell carcinoma. Methods and Materials: A total of 24 patients were enrolled in an institutional review board-approved clinical trial; data for 22 of these patients were analyzed. Daily CT-guided setup and deformable image registration permitted serial mapping of clinical target volumes and avoidance structures for ART planning. Primary site was base of tongue in 15 patients, tonsil in 6 patient, and glossopharyngeal sulcus in 1 patient. Twenty patients (91%) had American Joint Committee on Cancer (AJCC) Stage IV disease. T stage distribution was 2 T1, 12 T2, 3 T3, 5 T4. N stage distribution was 1 N0, 2 N1, 5 N2a, 12 N2b, and 2 N2c. Of the patients, 21 (95%) received systemic therapy. Results: With a 31-month median follow-up (range, 13-45 months), there has been no primary site failure and 1 nodal relapse, yielding 100% local and 95% regional disease control at 2 years. Baseline tumor size correlated with absolute volumetric treatment response (p = 0.018). Parotid volumetric change correlated with duration of feeding tube placement (p = 0.025). Acute toxicity was comparable to that observed with conventional intensity-modulated radiotherapy (IMRT). Chronic toxicity and functional outcomes beyond 1 year were tabulated. Conclusion: This is the first prospective evaluation of morbidity and survival outcomes in patients with locally advanced head-and-neck cancer treated with automated adaptive replanning. ART can provide dosimetric benefit with only one or two mid-treatment replanning events. Our preliminary clinical outcomes document functional recovery and preservation of disease control at 1-year follow-up and beyond.

  1. Clinical features of headache at altitude: a prospective study.

    PubMed

    Silber, E; Sonnenberg, P; Collier, D J; Pollard, A J; Murdoch, D R; Goadsby, P J

    2003-04-08

    Headache is the most common nervous system complication at altitude; however, there have been few attempts to characterize clinical features of high-altitude headaches (HAH). To measure prospectively the incidence of HAH and to determine its risk factors and characteristics. Members of an expedition to Kanchenjunga base camp in Nepal (5,100 m) were prospectively studied. Subjects were interviewed prior to the trip and while trekking recorded headaches experienced at >3,000 m using a structured questionnaire incorporating International Headache Society (IHS) and acute mountain sickness (AMS) criteria. In addition, clinical features of headaches in 19 trekkers in other groups above 3,000 m were recorded using the same questionnaire. Eighty-three percent (50/60) reported at least 1 HAH (median 2, range 0 to 10). Those who developed HAH were younger (p = 0.04); women and persons with headaches in daily life were more likely to report severe headaches (p = 0.03 and p = 0.07). One hundred thirty-eight HAH, experienced by 69 persons, are described. The mean altitude at which headaches occurred was 4,723 m. Twenty-six percent of headaches woke subjects at night or occurred upon awakening. HAH reported by migraineurs were accompanied by more phonophobia (p = 0.008). There were no IHS accompanying symptoms in 44% of headaches or symptoms of AMS in 52% of headaches. Headaches are a frequent complication of ascent to altitude. Older age appears to offer some protection, whereas headaches were more severe in women and persons with headaches in daily life. There is a wide clinical spectrum, with some suggesting intracranial hypertension. There is a need for evidence-based diagnostic criteria for headaches at altitude.

  2. Bacterial keratitis: a prospective clinical and microbiological study

    PubMed Central

    Schaefer, F.; Bruttin, O.; Zografos, L.; Guex-Crosier, Y.

    2001-01-01

    AIM—To define the clinical and microbiological profile of bacterial keratitis at the Jules Gonin Eye Hospital and to test the in vitro bacterial resistance.
METHODS—Patients presenting with bacterial keratitis were prospectively followed; clinical features (age, risk factors, visual acuity) and response to therapy were analysed. Bacteriological profile was determined and the sensitivity/resistance of isolated strains were tested towards 12 ocular antibiotics (NCCLS disc diffusion test).
RESULTS—85 consecutive patients (mean age 44.3 (SD 20.7) years) were prospectively enrolled from 1 March 1997 to 30 November 1998. The following risk factors were identified: contact lens wear, 36%; blepharitis, 21%; trauma, 20%; xerophthalmia, 15%; keratopathies, 8%; and eyelid abnormalities, 6%. The most commonly isolated bacteria were Staphylococcus epidermidis, 40%; Staphylococcus aureus, 22%; Streptococcus pneumoniae, 8%; others Streptococcus species, 5%; Pseudomonas, 9%; Moraxella and Serratia marcescens, 5% each; Bacillus, Corynebacterium, Alcaligenes xyloxidans, Morganella morganii, and Haemophilus influenza, 1% each. 1-15% of strains were resistant to fluoroquinolones, 13-22% to aminoglycosides, 37% to cefazolin, 18% to chloramphenicol, 54% to polymyxin B, 51% to fusidic acid, and 45% to bacitracin. Five of the 85 patients (5.8%) had a poor clinical outcome with a visual loss of one or more lines of visual acuity.
CONCLUSION—Fluoroquinolones appear to be the therapy of choice for bacterial keratitis, but, based upon these in vitro studies, some strains may be resistant.

 PMID:11423460

  3. Early skin-to-skin contact after cesarean section: A randomized clinical pilot study

    PubMed Central

    Kollmann, Martina; Aldrian, Lisa; Scheuchenegger, Anna; Mautner, Eva; Herzog, Sereina A.; Urlesberger, Berndt; Raggam, Reinhard B.; Lang, Uwe; Obermayer-Pietsch, Barbara; Klaritsch, Philipp

    2017-01-01

    Objective Early bonding by skin-to-skin contact (SSC) has been demonstrated to be beneficial for mothers and newborns following vaginal delivery. The aim of this study was to investigate the impact of intraoperative bonding (early SSC) after cesarean section on neonatal adaptation, maternal pain and stress response. Study design This prospective, randomized-controlled pilot study was performed at a single academic tertiary hospital (Department of Obstetrics and Gynecology, Medical University of Graz, Austria) between September 2013 and January 2014. Women were randomly assigned to intraoperative (“early”) SCC (n = 17) versus postoperative (“late”) SCC (n = 18). Main variables investigated were neonatal transition (Apgar score, arterial oxygen saturation, heart rate and temperature), maternal pain perception and both maternal and neonatal stress response by measuring the stress biomarkers salivary free cortisol and salivary alpha amylase. Results There was no evidence for differences in parameters reflecting neonatal transition or stress response between the ‘Early SSC Group’ and the ‘Late SSC Group’. Maternal salivary cortisol and alpha-amylase levels as well as maternal wellbeing and pain did not differ between the groups. However, the rise of maternal salivary alpha-amylase directly after delivery was higher in the ‘Early SSC Group’ compared to the ‘Late SSC Group’ (p = 0.004). Conclusions This study did not reveal significant risks for the newborn in terms of neonatal transition when early SSC is applied in the operating room. Maternal condition and stress marker levels did not differ either, although the rise of maternal salivary alpha-amylase directly after delivery was higher in the ‘Early SSC Group’ compared to the ‘Late SSC Group’, which may indicate a stressor sign due to intensive activation of the sympathetic-adreno-medullary-system. This needs to be further evaluated in a larger prospective randomized trial. Trial

  4. Clinical Impact of Sample Interference on Intensive Insulin Therapy in Severely Burned Patients: A Pilot Study

    PubMed Central

    Tran, Nam K.; Godwin, Zachary R.; Bockhold, Jennifer C.; Passerini, Anthony G.; Cheng, Julian; Ingemason, Morgan

    2013-01-01

    Objective Severely burned patients benefit from intensive insulin therapy (IIT) for tight glycemic control (TGC). We evaluated the clinical impact of automatic correction of hematocrit and ascorbic acid interference for bedside glucose monitoring performance in critically ill burn patients. Methods The performance of two point-of-care glucose monitoring systems (GMS): (a) GMS1, an autocorrecting device, and (b) GMS2, a non-correcting device were compared. Sixty remnant arterial blood samples were collected in a prospective observational study to evaluate hematocrit and ascorbic acid effects on GMS1 vs. GMS2 accuracy paired against a plasma glucose reference. Next we enrolled 12 patients in a pilot randomized controlled trial (RCT). Patients were randomized 1:1 to receive IIT targeting a TGC interval of 111–151 mg/dL and guided by either GMS1 or GMS2. GMS bias, mean insulin rate, and glycemic variability were calculated. Results In the prospective study, GMS1 results were similar to plasma glucose results (mean bias: −0.75[4.0] mg/dL, n=60, P=0.214). GMS2 results significantly differed from paired plasma glucose results (mean bias: −5.66[18.7] mg/dL, n=60, P=0.048). Ascorbic acid therapy elicited significant GMS2 performance bias (29.2[27.2], P<0.001). RCT results reported lower mean bias (P<0.001), glycemic variability (P<0.05), mean insulin rate (P<0.001), and frequency of hypoglycemia (P<0.001) in the GMS1 group than the GMS2 group. Conclusions Anemia and high dose ascorbic acid therapy negatively impact GMS accuracy and TGC in burn patients. Automatic correction of confounding factors improves glycemic control. Further studies are warranted to determine outcomes associated with accurate glucose monitoring during IIT. PMID:23884048

  5. The clinical picture of juvenile parotitis in a prospective setup.

    PubMed

    Saarinen, Riitta; Kolho, Kaija-Leena; Davidkin, Irja; Pitkäranta, Anne

    2013-02-01

    To characterize the features of juvenile parotitis in a prospective setup and epidemiology. All children with parotitis admitted to Helsinki University Central Hospital 2005-2010 were recruited. Clinical characteristics, given treatment, outcome, blood leukocyte count, C-reactive protein, serum amylase and trypsinogen, SPINK-1 genotype and mumps antibodies were recorded. To map the epidemiology, a questionnaire was sent to 1000 randomly selected 13-year-old children. The prospective study included 41 children (aged ≤ 17) with acute parotitis, all in good general condition. Serum amylase, but not trypsinogen, was elevated in majority of the cases (79%) and C-reactive protein in 68%. Eleven (27%) children had an elevated blood leukocyte count. None had acute mumps. Most children recovered well, 51% being treated symptomatically only. Seven children were treated on ward. Seventeen (46%) children had recurrent symptoms. One child (2.4%) had SPINK P55S mutation. According to the epidemiological questionnaire, 1.1% of the respondents (8/728, response rate 73%) reported a verified episode(s) of parotitis. Juvenile parotitis has a frequency close to 1%. In the majority, the general condition is good during the episode. Serum amylase serves as an additional marker for the disease. Parotitis has a tendency to recur in almost half of the cases. © 2012 The Author(s)/Acta Paediatrica © 2012 Foundation Acta Paediatrica.

  6. Pilot study of hemoglobinopathies in newborns of the Rafael Calvo maternity clinic of Cartagena, Colombia

    PubMed Central

    Barboza, Miriam; Viola, Maricela; Moneriz, Carlos; Araque, Luz Marina

    2012-01-01

    Introduction: The hemoglobinopathies are a heterogeneous group of congenital anemias from Africa, Asia and the Mediterranean. Due to the migration of this population have spread worldwide, especially in Latin America and the Caribbean region, which Cartagena de Indias is included, with a large proportion of people of African descent. The lack of routine programs that include an appropriate methodology for precise identification of those affected and carriers, impossible to know the real behavior of this disease in our country and an early and appropriate to the patients before the disease manifests itself and produce its serious consequences. Objective: To estimate the incidence and describe the epidemiological profile of hemoglobinopathies in newborns Rafael Calvo Maternity Clinic of Cartagena, in the period from January to June 2010. Methods: Prospective descriptive study of a population of 1,729 newborns. Samples were collected cord blood on filter paper. Isoelectric focusing electrophoresis (IEF )was used to separate the haemoglobins. Results: 94.4% (1,633 samples) were normal (hemoglobin FA), 4.5% (78 samples) were heterozygous for haemoglobin S (HbFAS), 1% (17samples) were heterozygous for haemoglobin C (hemoglobin FAC) and 0.1% (1 sample) was double heterozygous SC (hemoglobin FSC). Conclusion: Due to the high incidence of hemoglobinopathies found in this pilot study highlights the importance and necessity of establishing an obligatory neonatal screening in the city of Cartagena, in order to make a timely diagnosis and monitoring of affected and carrier. PMID:24893191

  7. Impact of the European clinical trials directive on prospective academic clinical trials associated with BMT.

    PubMed

    Frewer, L J; Coles, D; van der Lans, I A; Schroeder, D; Champion, K; Apperley, J F

    2011-03-01

    The European Clinical Trials Directive (EU 2001; 2001/20/EC) was introduced to improve the efficiency of commercial and academic clinical trials. Concerns have been raised by interested organizations and institutions regarding the potential for negative impact of the Directive on non-commercial European clinical research. Interested researchers within the European Group for Blood and Marrow Transplantation (EBMT) were surveyed to determine whether researcher experiences confirmed this view. Following a pilot study, an internet-based questionnaire was distributed to individuals in key research positions in the European haemopoietic SCT community. Seventy-one usable questionnaires were returned from participants in different EU member states. The results indicate that the perceived impact of the European Clinical Trials Directive has been negative, at least in the research areas of interest to the EBMT.

  8. Prospective genotyping of Mycobacterium tuberculosis from fresh clinical samples.

    PubMed

    Bidovec-Stojkovič, Urška; Seme, Katja; Žolnir-Dovč, Manca; Supply, Philip

    2014-01-01

    Shorter time-to-result is key for improving molecular-guided epidemiological investigation of tuberculosis (TB) cases. We performed a prospective study to evaluate the use of standardized MIRU-VNTR (mycobacterial interspersed repetitive-unit-variable-number tandem-repeat) typing of Mycobacterium tuberculosis directly on 79 fresh clinical samples from 26 TB patients consecutively enrolled over a 17-month period. Overall, complete 24-locus types were obtained for 18 out of the 26 (69.2%) patients and 14 of the 16 grade 3+ and grade 2+ samples (87.5%). The degree of completion of the genotypes obtained significantly correlated with smear microscopy grade both for 26 first samples (p = 0.0003) and for 53 follow-up samples (p = 0.002). For 20 of the 26 patients for whom complete or even incomplete M. tuberculosis isolate genotypes were obtained, typing applied to the clinical samples allowed the same unambiguous conclusions regarding case clustering or uniqueness as those that could have been drawn based on the corresponding cultured isolates. Standard 24 locus MIRU-VNTR typing of M. tuberculosis can be applied directly to fresh clinical samples, with typeability depending on the bacterial load in the sample.

  9. Liquid-type Botulinum Toxin Type A in Adductor Spasmodic Dysphonia: A Prospective Pilot Study.

    PubMed

    Cha, Wonjae; Jang, Jeon Yeob; Wang, Soo-Geun; Kang, Ji-Heon; Jo, Min-Gyu

    2017-05-01

    Botulinum toxin (BTX) has been widely used to treat adductor spasmodic dysphonia (ADSD). Most commercially available forms of BTX require reconstitution before use, which may increase the risk of contamination and requires careful titration. Recently, a liquid-type BTX type A (BTX-A) has been developed, which should simplify the procedure and enhance its efficacy. Herein, we present a prospective pilot study to investigate the efficacy and safety of liquid-type BTX-A in the treatment of ADSD. Twenty-six consecutive liquid-type BTX-A injections were performed in 12 patients with ADSD. We included as a control group 34 consecutive patients with ADSD who had previously undergone 52 vocal fold injection procedures with freeze-dried-type BTX-A. All patients in both groups had improvement of symptoms related to ADSD and period of normal voice. Most patients experienced breathiness, and the onset time, the peak response time, and the duration of breathiness were similar in both groups. The duration of effect (days) was 96.96 ± 18.91 and 77.38 ± 18.97 in the freeze-dried-type and the liquid-type groups, and the duration of benefit (days) was 80.02 ± 18.24 and 62.69 ± 19.73 in the freeze-dried-type and the liquid-type groups. To compare the efficacy between the freeze-dried-type and the liquid-type BTX-A, the sessions of the unilateral vocal fold injection were included and were categorized as group A (1 ~ 2 units BTX-A) and group B (2 ~ 3 units BTX-A), according to the dose per vocal fold. There was no significant difference of effect time between freeze-dried-type and liquid-type BTX-A groups. No adverse events related to BTX or vocal fold injection were reported. Liquid-type BTX-A is safe and effective for the treatment of spasmodic dysphonia. With the advantages of simple preparation, storage, and reuse and animal protein-free constituents, liquid-type BTX-A may be a good option in the treatment of spasmodic dysphonia. Copyright © 2017 The

  10. Diagnosing epilepsy in neurology clinics: a prospective study.

    PubMed

    Angus-Leppan, Heather

    2008-07-01

    The certainty of the initial diagnosis of epilepsy was assessed prospectively by one neurologist in outpatients. One hundred and fifty-eight consecutive referrals with loss of consciousness or possible epilepsy were seen. The relative contributions to the initial diagnosis from the referral letter, history taking in clinic, physical examination, and investigation were compared. There was a referring diagnosis in 28.5%. The neurologist reached a diagnosis in 87% of the 158 cases: in 43% epilepsy, 25% syncope, 12% non-epileptic seizures and in 7% other diagnoses. There was a low correlation between referral and specialist diagnosis. Physical examination did not change the diagnosis in any patient. Investigations changed the diagnosis in one patient. Neuro-imaging revealed a relevant abnormality in 12/43 (27.9%) scanned. The yield from EEG was 7/25 (28%), but the EEG changed the diagnosis in only one case. Cardiac testing confirmed the type of syncope in 2/47 (4.3%) of patients. Blood tests did not contribute to the diagnosis in any patient. The neurology consultation significantly increased diagnostic certainty. The diagnosis of epilepsy remains largely clinical. It is important that patients are aware of this prior to investigation.

  11. A prospective clinical study of polycarboxylate cement in periapical surgery

    PubMed Central

    Ortega-Sánchez, Bárbara; García-Mira, Berta; Maestre-Ferrín, Laura; Peñarrocha-Oltra, David; Gay-Escoda, Cosme

    2012-01-01

    Objective: To evaluate the clinical efficacy of polycarboxylate cement as retrograde filling material. Design: A prospective clinical study was made of 25 patients subjected to periapical surgery with ultrasound and magnifying loupes, in which polycarboxylate cement was used as retrograde filling material. Measurements were made of the area and diameter of the lesions pre- and postoperatively, and 6 and 12 months after the operation. The apical resection and retrograde filling areas were also measured, and the prognosis following surgery was recorded. Results: A total of 23 patients with 31 apicoectomized teeth were studied (2 patients being lost to follow-up). The mean area of the periapical lesions before surgery was 52.25 mm2, with a mean major diameter of 6.1 mm and a mean lesser diameter of 4.8 mm. The success rate after 12 months was 54.7%, according to the criteria of Von Arx and Kurt. The prognosis was poorer in females, in larger lesions, and in cases with larger retrograde filling areas. Conclusions: Polycarboxylate cement offers good results, with important bone regeneration after periapical surgery. Key words: Periapical surgery, endodontic treatment, polycarboxylate cement. PMID:22143701

  12. Children's Views Matter Too! A Pilot Project Assessing Children's and Adolescents' Experiences of Clinical Psychology Services

    ERIC Educational Resources Information Center

    Gordon, Michael; Russo, Kate

    2009-01-01

    This pilot study explored the experiences and understanding of clinical psychology practices and services of children and adolescents attending clinical psychology outpatient appointments. Fifteen young participants took part in the study. A content analysis indicated that young children and adolescents have an appropriate understanding of the…

  13. Children's Views Matter Too! A Pilot Project Assessing Children's and Adolescents' Experiences of Clinical Psychology Services

    ERIC Educational Resources Information Center

    Gordon, Michael; Russo, Kate

    2009-01-01

    This pilot study explored the experiences and understanding of clinical psychology practices and services of children and adolescents attending clinical psychology outpatient appointments. Fifteen young participants took part in the study. A content analysis indicated that young children and adolescents have an appropriate understanding of the…

  14. Comparison of Alpha Blockers in Treatment of Premature Ejaculation: A Pilot Clinical Trial

    PubMed Central

    Akin, Yigit; Gulmez, Hakan; Ates, Mutlu; Bozkurt, Aliseydi; Nuhoglu, Baris

    2013-01-01

    Background: Premature ejaculation (PE) is the most common sexual disorder in men and studies reported prevalence up to 30% (1, 2). PE is not a life-threatening medical condition but it influences the quality of life (QoL). Objectives: The aim of this study was to compare the efficiency, and safety of alpha blocker drugs in the treatment of patients with premature ejaculation (PE). Additionally we investigated the quality of life (QoL) in patients with PE who were treated with alpha blocker drugs. Materials and Methods: This study was a pilot clinical trial. Prospectively documented 108 patients with PE were treated and were followed-up in urology outpatient clinic. All patients were divided into 5 groups according to used alpha blocker agents which were determined by simple randomization. Silodosin 4mg (Group 1, n = 21), tamsulosin hydrochloride 0.4mg (Group 2, n = 23), alfuzosin 10mg (Group 3, n = 22), terazosin 5mg (Group 4, n = 21), doksazosin mesylate 4mg (Group5, n = 21), were used for treatment. The demographic parameters of patients, pre and post treatment intravaginal ejaculation latency time (IELT), PE Profile (PEP), and QoL index were recorded and evaluated. Effectiveness of treatment was evaluated by measuring IELT. Additionally, side effects of drugs were recorded. P < 0.05 was considered statistically significant. Results: All alpha blocker drugs were statistically effective for preventing PE. Notably, silodosin seemed to be more effective for preventing PE than other alpha blockers (P < 0.05). However all alpha blockers provided development in QoL scores, silodosin was a little better than other drugs in statistical analyses. Furthermore statistical increase in IELT and decrease in PEP were provided more in Group 1 than other groups (P < 0.05). Conclusions: Silodosin seems to be able to even more prevent PE. Silodosin may provide development in QoL than other alpha blocker agents. Additionally, lower systemic adverse events and more effectivity are

  15. Detailed prospective peer review in a community radiation oncology clinic.

    PubMed

    Mitchell, James D; Chesnut, Thomas J; Eastham, David V; Demandante, Carlo N; Hoopes, David J

    In 2012, we instituted detailed prospective peer review of new cases. We present the outcomes of peer review on patient management and time required for peer review. Peer review rounds were held 3 to 4 days weekly and required 2 physicians to review pertinent information from the electronic medical record and treatment planning system. Eight aspects were reviewed for each case: 1) workup and staging; 2) treatment intent and prescription; 3) position, immobilization, and simulation; 4) motion assessment and management; 5) target contours; 6) normal tissue contours; 7) target dosimetry; and 8) normal tissue dosimetry. Cases were marked as, "Meets standard of care," "Variation," or "Major deviation." Changes in treatment plan were noted. As our process evolved, we recorded the time spent reviewing each case. From 2012 to 2014, we collected peer review data on 442 of 465 (95%) radiation therapy patients treated in our hospital-based clinic. Overall, 91 (20.6%) of the cases were marked as having a variation, and 3 (0.7%) as major deviation. Forty-two (9.5%) of the cases were altered after peer review. An overall peer review score of "Variation" or "Major deviation" was highly associated with a change in treatment plan (P < .01). Changes in target contours were recommended in 10% of cases. Gastrointestinal cases were significantly associated with a change in treatment plan after peer review. Indicators on position, immobilization, simulation, target contours, target dosimetry, motion management, normal tissue contours, and normal tissue dosimetry were significantly associated with a change in treatment plan. The mean time spent on each case was 7 minutes. Prospective peer review is feasible in a community radiation oncology practice. Our process led to changes in 9.5% of cases. Peer review should focus on technical factors such as target contours and dosimetry. Peer review required 7 minutes per case. Published by Elsevier Inc.

  16. Medical student use of communication elements and association with patient satisfaction: a prospective observational pilot study.

    PubMed

    Turner, Joseph S; Pettit, Katie E; Buente, Bryce B; Humbert, Aloysius J; Perkins, Anthony J; Kline, Jeffrey A

    2016-05-21

    Effective communication with patients impacts clinical outcome and patient satisfaction. We measure the rate at which medical students use six targeted communication elements with patients and association of element use with patient satisfaction. Participants included fourth year medical students enrolled in an emergency medicine clerkship. A trained observer measured use of six communication elements: acknowledging the patient by name, introducing themselves by name, identifying their role, explaining the care plan, explaining that multiple providers would see the patient, and providing an estimated duration of time in the emergency department. The observer then conducted a survey of patient satisfaction with the medical student encounter. A total of 246 encounters were documented among forty medical student participants. For the six communication elements evaluated, in 61% of encounters medical students acknowledged the patient, in 91% they introduced themselves, in 58 % they identified their role as a student, in 64% they explained the care plan, in 80% they explained that another provider would see the patient, and in only 6% they provided an estimated duration of care. Only 1 encounter (0.4%) contained all six elements. Patients' likelihood to refer a loved one to that ED was increased when students acknowledged the patient and described that other providers would be involved in patient care (P = 0.016 and 0.015 respectively, Chi Square). Likewise, patients' likelihood to return to the ED was increased when students described their role in patient care (P = 0.035, Chi Square). This pilot study demonstrates that medical students infrequently use all targeted communication elements. When they did use certain elements, patient satisfaction increased. These data imply potential benefit to additional training for students in patient communication.

  17. Safety and efficacy of a new honey ointment on diabetic foot ulcers: a prospective pilot study.

    PubMed

    Abdelatif, M; Yakoot, M; Etmaan, M

    2008-03-01

    To study the effectiveness and safety of PEDYPHAR ointment (a new ointment prepared from natural royal jelly and panthenol in an ointment base) in the treatment of patients with limb-threatening diabetic foot infections. Sixty patients presenting with limb-threatening diabetic foot infection were categorised into three groups, based on the severity of the lesions. Group I: full-thickness skin ulcer (Wagner grades 1 and 2); group 2: deep tissue infection and suspected osteomyelitis (grade 3); group 3: gangrenous lesions (grades 4 and 5). They were treated with PEDYPHAR ointment after irrigation and cleansing with normal saline, and surgical debridement if required. The lesions were covered with dressings and patients were followed up for six months or until full healing occurred. No other specific treatment was given apart from insulin treatment to control the diabetes. The primary endpoint was the clinical response at weeks 3, 9 and 24 from the start of treatment. Ninety-six per cent of the patients in groups 1 and 2 responded well, with a complete cure, defined as'complete closure of the ulcer without signs of underlying bone infection' by the end of week 9 and for the duration of the six-month follow-up period. All of the ulcers in group 1 healed, as did 92% of those in group 2. All patients in group 3 healed following surgical excision, debridement of necrotic tissue and conservative treatment with PEDYPHAR ointment. We can conclude from our pilot study that PEDYPHAR ointment may be a promising, safe conservative local treatment. However, further double-blind randomised controlled studies are needed to confirm this.

  18. Prospective pilot study of a single daily dosage of trientine for the treatment of Wilson disease.

    PubMed

    Ala, Aftab; Aliu, Ermal; Schilsky, Michael L

    2015-05-01

    Wilson disease requires lifelong therapy, currently given daily in multiple divided dosages. To prospectively evaluate once-daily trientine as therapy for Wilson disease. eight patients (seven males) aged 22-71 years with stable Wilson disease treated from 4 to 50 years. Patients were monitored for 3 months then for 12 months on a single daily dose of trientine (15 mg/kg). All patients remained clinically well. ALT and AST fluctuated in some, but none required treatment stoppages or side effects. Liver synthetic function was unchanged. Mean 24-h urine copper and zinc excretions at end of treatment were 313.4 ± 191.7 and 2,214 ± 1,346 μg, respectively. Once-daily trientine should be explored further for possible maintenance therapy for WD. Single daily dose may improve adherence to therapy. Larger trials and longer-term follow-up will establish the safety and treatment efficacy of this once-daily treatment regimen for WD (registration: NCT01472874).

  19. The impacts of adenotonsillar hypertrophy on periodontal health in children: a prospective controlled pilot study.

    PubMed

    Demir, Uygar Levent; Cetinkaya, Burcu; Karaca, Sait; Sigirli, Deniz

    2013-01-01

    To evaluate the impacts of obstructive adenotonsillar disease on periodontal health and to assess the efficacy of adenotonsillectomy in the prevention of chronic periodontitis in children. This prospective and controlled clinical study was conducted between August 2012 and February 2013 with 35 pediatric patients who had permanent anterior dentition. The study group included twenty patients (n = 20) who had complaints of chronic mouth breathing and snoring and were diagnosed with obstructive adenotonsillar disease. These patients underwent adenoidectomy with or without tonsillectomy. We performed periodontal examinations to assess the periodontal health status in these children before and two months after surgery. The periodontal measures included plaque index (PI), pocket depth (PD) and gingival index scores (GI). Subsequently, these periodontal measures were compared with healthy control group who had no adenotonsillar disease (n = 15). Among the study group six patients underwent adenoidectomy and 14 patients underwent adenoidectomy combined with either tonsillectomy or tonsillotomy. The preoperative PI, PD and GI scores of the study group were 1.27 ± 0.39, 1.34 ± 0.31 and 0.97 ± 0.37 respectively. These scores were significantly higher compared to the control group (p < 0.001). These periodontal index scores were significantly improved after surgery (p = 0.008 for PI and p < 0.001 for both PD and GI). In addition, we found no difference in postoperative values of PD and GI between the study group and control group. We concluded that obstructive adenotonsillar disease adversely affects periodontal health in children and surgical management of obstruction improves the clinical findings. However, more comprehensive research is required to elucidate the association between adenotonsillar hypertrophy and periodontal disease. Copyright © 2013 Elsevier Inc. All rights reserved.

  20. A Pilot Prospective Randomized Control Trial Comparing Exercises Using Videogame Therapy to Standard Physical Therapy: 6 Months Follow-Up.

    PubMed

    Parry, Ingrid; Painting, Lynda; Bagley, Anita; Kawada, Jason; Molitor, Fred; Sen, Soman; Greenhalgh, David G; Palmieri, Tina L

    2015-01-01

    Commercially available, interactive videogames that use body movements for interaction are used clinically in burn rehabilitation and have been shown to facilitate functional range of motion (ROM) but their efficacy with burn patients has not yet been proven. The purpose of this pilot randomized control study was to prospectively compare planar and functional ROM, compliance, pain, enjoyment, and exertion in pediatric burn patients receiving two types of rehabilitation therapy. Seventeen school-aged children with 31 affected limbs who demonstrated limited shoulder ROM from burn injury were randomized to receive exercises using either standard therapy ROM activities (ST) or interactive videogame therapy (VGT). Patients received 3 weeks of the designated therapy intervention twice daily. They were then given a corresponding home program of the same type of therapy to perform regularly for 6 months. Standard goniometry and three-dimensional motion analysis during functional tasks were used to assess ROM. Measures were taken at baseline, 3 weeks, 3 months, and 6 months. Pain was measured before and after each treatment session during the 3-week intervention. There was no difference in compliance, enjoyment, or exertion between the groups. Patients in both the ST and VGT groups showed significant improvement in shoulder flexion (P < .001), shoulder abduction (P <.001), shoulder external rotation (P = .01), and elbow flexion (P = .004) ROM from baseline to 6 months as measured with goniometry. Subjects also showed significant gains in elbow flexion (P = .04) during hand to head and shoulder flexion (P = .04) during high reach. There was no difference in ROM gains between the groups. Within group comparison showed that the VGT group had significantly more recovery of ROM during the first 3 weeks than any other timeframe in the study, whereas ST had most gains at 3 months. There was a significant difference between the groups in the subjects' pain response. ST subjects

  1. Idiopathic intracranial hypertension: ongoing clinical challenges and future prospects

    PubMed Central

    Julayanont, Parunyou; Karukote, Amputch; Ruthirago, Doungporn; Panikkath, Deepa; Panikkath, Ragesh

    2016-01-01

    Idiopathic intracranial hypertension (IIH) is an uncommon disorder characterized by increased intracranial pressure without radiological or laboratory evidence of intracranial pathology except empty sella turcica, optic nerve sheath with filled out cerebrospinal fluid spaces, and smooth-walled nonflow-related venous sinus stenosis or collapse. This condition typically affects obese women. The incidence of IIH is increasing with the rising prevalence of obesity. Persistent headache is the most common symptom. Visual impairment is a serious complication that may not be recognized by the patients. This paper reviews clinical manifestations, diagnostic challenges, and current treatments of IIH in adults. Various imaging modalities have been studied on their validity for detection of IIH and papilledema. This review also includes new studies on medical, surgical, and interventional management of this condition. Acetazolamide and topiramate are the only two medications that have been studied in randomized controlled trials about their efficacy in treatment of IIH. In patients who have severe visual impairment or progressive visual deterioration despite medical management, surgical or interventional treatment may be considered. The efficacy and complications of cerebrospinal fluid diversion, optic nerve sheath fenestration, and endovascular venous stenting reported in the last 3 decades have been summarized in this review. Finally, the prospective aspects of biomarkers and treatments are proposed for future research. PMID:26929666

  2. Prospective randomized clinical trial: single and weekly viscosupplementation

    PubMed Central

    Zóboli, Alejandro Agustin Carri; de Rezende, Márcia Uchôa; de Campos, Gustavo Constantino; Pasqualin, Thiago; Frucchi, Renato; de Camargo, Olavo Pires

    2013-01-01

    OBJECTIVE: To compare two different dosages of an intermediate molecular weight sodium hyaluronate (HA) (Osteonil®-TRB Pharma) assessing whether a single 6 ml application of this HA has the same effectiveness as the classical three-weekly 2 ml dose. METHODS: 108 patients with knee osteoarthritis were randomized into two groups of 54 patients each. The groups were designated "single" (S) and "weekly" (W). Patients in group S underwent a viscosupplementation procedure by application of only 6 ml of sodium hyaluronate and 1 ml triamcinolone hexacetonide. Patients in group W underwent the procedure of viscosupplementation through three applications with 2 ml sodium hyaluronate with a week interval between them, and the first application was also performed with the infiltration of 1 ml (20 mg) of Triamcinolone Hexacetonide. Both groups were assessed before, at one month and three months after application, by responding to the WOMAC, Lequesne, IKDC and VAS questionnaires. RESULTS: There was no statistical difference between the single application of 6 ml of sodium hyaluronate and classic application with three weekly injections. However, only the classical regime showed statistically significant improvement in baseline pain (WOMAC pain and VAS). CONCLUSION: Our results suggest that both application schemes improve application function, but the three-weekly regimen of 2 ml was more effective in reducing pain. Level of Evidence I, Prospective Randomized, Clinical Trial. PMID:24453681

  3. Nonalcoholic Fatty Liver Disease is Associated with Erectile Dysfunction: A Prospective Pilot Study.

    PubMed

    Duman, Deniz Güney; Biçakci, Ercan; Çelikel, Çiğdem Ataizi; Akbal, Cem

    2016-03-01

    Nonalcoholic fatty liver disease (NAFLD) is considered the hepatic manifestation of metabolic syndrome (MetS). Although the link between MetS and erectile dysfunction (ED) is well known, clinical studies investigating the association between NAFLD and ED are scant. To evaluate the relationship between NAFLD and ED. Male patients with biopsy-proven NAFLD were prospectively asked to fill the five-item International Index of Erectile Function (IIEF-5) questionnaire. Their clinical and histologic variables were compared with the IEFF scores. IIEF scores; proportions of NAFLD patients who demonstrated ED and/or MetS; association between the severity of histological hepatic damage and ED. Forty male patients having an age range of 33 (24-57) and a mean age of 40.13 ± 10.22 years with biopsy-proven NAFLD had a median IIEF-5 score of 16 (9-25) and MetS was present in 23 (57.5%). ED severity distributions as moderate, mild, and no ED were 11 (27.5%), 16 (40%), and 13 (32.5 %), respectively. Histological NAFLD score was significantly higher in patients having ED compared with patients with no ED (5.63 ± 1.39 vs. 4.15 ± 1.46; P = .006). MetS diagnosis was significantly more common in patients having ED, compared with those without ED [19 (70.4%) vs. 4 (30.8%), respectively, P = .018)]. When patients with and without ED were compared, gamma glutamyl transferase was significantly lower in ED, whereas components of MetS did not correlate with ED. After multivariate analysis, NAFLD score has remained the only significant outcome associated with ED [P = .03; OR (95% CI): 2.38 (1.079-5.238)]. The current clinical study demonstrates a significant association between nonalcoholic steatohepatitis and ED for the first time. Our findings suggest liver damage may play role in the pathogenesis of ED in patients with NAFLD. Future studies are needed to expand the underlying common mechanisms responsible for this novel hypothesis. Copyright © 2016 International Society for Sexual

  4. Prospective clinical evaluation of a novel anatomic cuff for forearm crutches in patients with osteoarthritis.

    PubMed

    Hügle, Thomas; Arnieri, Ansgar; Bünter, Margerita; Schären, Stefan; Mündermann, Annegret

    2017-03-14

    The use of forearm crutches has been associated with pain and neuropraxia along the ulnar bone. Whilst anatomic grips have improved comfort of crutch walking, to date anatomic forearm cuffs have not been clinically evaluated. The aim of this clinical pilot study was to determine if the use of forearm crutches with anatomic cuffs reduces pain and increases comfort and function in long-term users of forearm crutches during a 4-week period. Prospective study in ten patients suffering from end-stage osteoarthritis of the lower extremity. All participants were long-term users of conventional forearm crutches. Participants used forearm crutches with an anatomically shaped cuff for 4-weeks. General health was assessed using the SF-36, and the crutches were evaluated using a newly developed questionnaire focusing on symptoms along the forearm. Pain and paresthesia along the forearms decreased by 3.3 points (95% confidence interval difference (CI): [-5.0; -1.6], p = .004) and 3.5 points (95%CI: [-5.1; -1.9], p = .002), respectively, after using the crutches with the new anatomic cuff for 4 weeks. Comfort and sense of security of crutch use increased by 3.0 points (95%CI: [1.3; 4.7], p = .007) and 2.4 points (95%CI: [0.7; 4.1], p = .024). Cross-correlation analysis revealed correlations among items in the same item category and no correlations between items of different item categories of the new questionnaires. An anatomically shaped cuff increases comfort of forearm crutches. Further research should confirm long-term clinical improvement. This study was registered retrospectively in ISRCTN (TRN: ISRCTN 11135150 ) on 14/02/2017.

  5. Minimal clinically important difference of the L Test for individuals with lower limb amputation: A pilot study.

    PubMed

    Rushton, Paula W; Miller, William C; Deathe, A Barry

    2015-12-01

    The L Test is a reliable/valid clinical evaluation of mobility that measures walking speed in seconds. It can be used with individuals with lower limb amputation. Responsiveness of the L Test is not yet determined. The purpose of this pilot study was to determine how well the L Test identified individuals with a lower limb amputation who have/have not undergone a minimal clinically important difference. Prospective follow-up study. In total, 33 individuals with lower limb amputation, deemed to require a major intervention, were recruited consecutively from a follow-up clinic. Participants completed the L Test at baseline and follow-up. A Global Rating Change scale was also completed at follow-up. The participants had a mean age ± standard deviation of 60 ± 13.0 years, and 81.8% had a transtibial amputation. The mean ± standard deviation for the L Test change scores was 6.0 ± 13.9. The area under the curve was 0.67, and the minimal clinically important difference was 4.5 s. The L Test identified individuals as having an important clinical change. Results must be interpreted with caution, as the accuracy, based on the Global Rating Change scale, is low. Further inquiry into the L Test is encouraged. The L Test can guide the clinical management of individuals with lower limb amputation. Results from this pilot study indicate that individuals with a lower limb amputation who improve by at least 4.5 s on the L Test after an intervention have likely undergone an important change. This result must be interpreted with caution given that the ability of the L Test to correctly identify individuals, who have and have not undergone an important change, using the Global Rating Change scale as the gold standard, is limited because this is a pilot study. It is plausible that the precision of the cut-point threshold could increase or decrease given a larger sample or when using a different method of identifying important clinical change. © The International Society for

  6. Homeopathic Secretin in autism: a clinical pilot study.

    PubMed

    Robinson, T W

    2001-04-01

    Autism is a condition characterised by impairments of social communication, social interaction and social imagination. The exact aetiology of autism is unknown but some autistic features have been explained by the 'opioid excess theory' in which excess brain peptide levels have a morphine-like activity. Reduction of peptide levels by administration of the duodenal enzyme Secretin has been found to improve social and language skills in autistic patients. Homeopathic Secretin has been said to produce similar effects. A pilot study was undertaken to study these effects by administration of Secretin to a group of autistic patients. Weekly assessment for 12 weeks was performed by the patients' care workers. Statistical analysis of the mean pre-treatment results compared with the mean treatment results suggested a worsening in the autistic symptoms during treatment. Discussion with the care workers revealed changes and some improvements that were not recordable on the scoring system. Further research into Secretin treatment of autism using a more detailed and customized scoring system would be justified. Following this pilot study a randomised controlled trial of Secretin vs placebo would be appropriate.

  7. Effects of carnosine supplementation on glucose metabolism: Pilot clinical trial.

    PubMed

    de Courten, Barbora; Jakubova, Michaela; de Courten, Maximilian Pj; Kukurova, Ivica Just; Vallova, Silvia; Krumpolec, Patrik; Valkovic, Ladislav; Kurdiova, Timea; Garzon, Davide; Barbaresi, Silvia; Teede, Helena J; Derave, Wim; Krssak, Martin; Aldini, Giancarlo; Ukropec, Jozef; Ukropcova, Barbara

    2016-05-01

    Carnosine is a naturally present dipeptide in humans and an over-the counter food additive. Evidence from animal studies supports the role for carnosine in the prevention and treatment of diabetes and cardiovascular disease, yet there is limited human data. This study investigated whether carnosine supplementation in individuals with overweight or obesity improves diabetes and cardiovascular risk factors. In a double-blind randomized pilot trial in nondiabetic individuals with overweight and obesity (age 43 ± 8 years; body mass index 31 ± 4 kg/m(2) ), 15 individuals were randomly assigned to 2 g carnosine daily and 15 individuals to placebo for 12 weeks. Insulin sensitivity and secretion, glucose tolerance (oral glucose tolerance test), blood pressure, plasma lipid profile, skeletal muscle ((1) H-MRS), and urinary carnosine levels were measured. Carnosine concentrations increased in urine after supplementation (P < 0.05). An increase in fasting insulin and insulin resistance was hampered in individuals receiving carnosine compared to placebo, and this remained significant after adjustment for age, sex, and change in body weight (P = 0.02, P = 0.04, respectively). Two-hour glucose and insulin were both lower after carnosine supplementation compared to placebo in individuals with impaired glucose tolerance (P < 0.05). These pilot intervention data suggest that carnosine supplementation may be an effective strategy for prevention of type 2 diabetes. © 2016 The Obesity Society.

  8. Monitoring Central Venous Catheter Resistance to Predict Imminent Occlusion: A Prospective Pilot Study.

    PubMed

    Wolf, Joshua; Tang, Li; Rubnitz, Jeffrey E; Brennan, Rachel C; Shook, David R; Stokes, Dennis C; Monagle, Paul; Curtis, Nigel; Worth, Leon J; Allison, Kim; Sun, Yilun; Flynn, Patricia M

    2015-01-01

    Long-term central venous catheters are essential for the management of chronic medical conditions, including childhood cancer. Catheter occlusion is associated with an increased risk of subsequent complications, including bloodstream infection, venous thrombosis, and catheter fracture. Therefore, predicting and pre-emptively treating occlusions should prevent complications, but no method for predicting such occlusions has been developed. We conducted a prospective trial to determine the feasibility, acceptability, and efficacy of catheter-resistance monitoring, a novel approach to predicting central venous catheter occlusion in pediatric patients. Participants who had tunneled catheters and were receiving treatment for cancer or undergoing hematopoietic stem cell transplantation underwent weekly catheter-resistance monitoring for up to 12 weeks. Resistance was assessed by measuring the inline pressure at multiple flow-rates via a syringe pump system fitted with a pressure-sensing transducer. When turbulent flow through the device was evident, resistance was not estimated, and the result was noted as "non-laminar." Ten patients attended 113 catheter-resistance monitoring visits. Elevated catheter resistance (>8.8% increase) was strongly associated with the subsequent development of acute catheter occlusion within 10 days (odds ratio = 6.2; 95% confidence interval, 1.8-21.5; p <0.01; sensitivity, 75%; specificity, 67%). A combined prediction model comprising either change in resistance greater than 8.8% or a non-laminar result predicted subsequent occlusion (odds ratio = 6.8; 95% confidence interval, 2.0-22.8; p = 0.002; sensitivity, 80%; specificity, 63%). Participants rated catheter-resistance monitoring as highly acceptable. In this pediatric hematology and oncology population, catheter-resistance monitoring is feasible, acceptable, and predicts imminent catheter occlusion. Larger studies are required to validate these findings, assess the predictive value for

  9. A prospective single centre pilot evaluation of a serum calprotectin assay in unselected GI patients.

    PubMed

    McCann, Rebecca K; Smith, Karen; Gaya, Daniel R

    2017-06-01

    Whilst C-reactive protein (CRP) is an established serum marker of inflammation, its use in gastroenterology has been limited by its poor sensitivity and specificity for GI disease. Faecal calprotectin (FC) has been adopted into mainstream GI practice as a sensitive but non-specific marker of intestinal inflammation. However, stool samples collection for FC can be challenging and the possibility of utilising a sensitive and specific serum biomarker of intestinal inflammation in luminal gastroenterology is an attractive prospect. This work investigates the performance of serum calprotectin (SC) compared to current biomarkers, FC and CRP, in an unselected cohort of patients attending our GI unit. Patients attending in and outpatients within an adult GI service who submitted a stool sample for FC analysis were identified. A total of 109 who had a serum sample obtained within one day of stool sample collection had the serum analysed for CRP and SC and the correlation between these biomarkers was investigated. The intraclass correlation coefficient (ICC) between SC, FC and CRP was 0.10, 95% CI -0.09-0.28 and 0.18, 95% CI -0.01-0.35, respectively. The ICC between FC and CRP was 0.18, 95% CI -0.01-0.35. Our data reveals that there is no significant correlation between SC and FC, nor between SC and CRP in a large unselected cohort of GI patients. Therefore, as a serum biomarker for intestinal inflammation, SC is unlikely to be of clinical utility and the search for an appropriate serum GI biomarker continues. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  10. Monitoring Central Venous Catheter Resistance to Predict Imminent Occlusion: A Prospective Pilot Study

    PubMed Central

    Wolf, Joshua; Tang, Li; Rubnitz, Jeffrey E.; Brennan, Rachel C.; Shook, David R.; Stokes, Dennis C.; Monagle, Paul; Curtis, Nigel; Worth, Leon J.; Allison, Kim; Sun, Yilun; Flynn, Patricia M.

    2015-01-01

    Background Long-term central venous catheters are essential for the management of chronic medical conditions, including childhood cancer. Catheter occlusion is associated with an increased risk of subsequent complications, including bloodstream infection, venous thrombosis, and catheter fracture. Therefore, predicting and pre-emptively treating occlusions should prevent complications, but no method for predicting such occlusions has been developed. Methods We conducted a prospective trial to determine the feasibility, acceptability, and efficacy of catheter-resistance monitoring, a novel approach to predicting central venous catheter occlusion in pediatric patients. Participants who had tunneled catheters and were receiving treatment for cancer or undergoing hematopoietic stem cell transplantation underwent weekly catheter-resistance monitoring for up to 12 weeks. Resistance was assessed by measuring the inline pressure at multiple flow-rates via a syringe pump system fitted with a pressure-sensing transducer. When turbulent flow through the device was evident, resistance was not estimated, and the result was noted as “non-laminar.” Results Ten patients attended 113 catheter-resistance monitoring visits. Elevated catheter resistance (>8.8% increase) was strongly associated with the subsequent development of acute catheter occlusion within 10 days (odds ratio = 6.2; 95% confidence interval, 1.8–21.5; p <0.01; sensitivity, 75%; specificity, 67%). A combined prediction model comprising either change in resistance greater than 8.8% or a non-laminar result predicted subsequent occlusion (odds ratio = 6.8; 95% confidence interval, 2.0–22.8; p = 0.002; sensitivity, 80%; specificity, 63%). Participants rated catheter-resistance monitoring as highly acceptable. Conclusions In this pediatric hematology and oncology population, catheter-resistance monitoring is feasible, acceptable, and predicts imminent catheter occlusion. Larger studies are required to validate

  11. Clinical pilot study of different hand positions during manual chest compressions monitored with capnography.

    PubMed

    Qvigstad, Eric; Kramer-Johansen, Jo; Tømte, Øystein; Skålhegg, Tore; Sørensen, Øyvar; Sunde, Kjetil; Olasveengen, Theresa M

    2013-09-01

    Optimal hand position for chest compressions during cardiopulmonary resuscitation is unknown. Recent imaging studies indicate significant inter-individual anatomical variations, which might cause varying haemodynamic responses with standard chest compressions. This prospective clinical pilot study intended to assess the feasibility of utilizing capnography to optimize chest compressions and identify the optimal hand position. Intubated cardiac arrest patients treated by the physician manned ambulance between February and December 2011 monitored with continuous end-tidal CO2 (EtCO2) measurements were included. One minute of chest compressions at the inter-nipple line (INL) optimized using EtCO2 feedback, was followed by four 30-s intervals with compressions at four different sites; INL, 2 cm below the INL, 2 cm below and to the left of INL and 2 cm below and to the right of INL. Thirty patients were included. At the end of each 30-s interval median (range) EtCO2 was 3.1 kPa (0.7-8.7 kPa) at INL, 3.5 kPa (0.5-10.7) 2 cm below INL, 3.5 kPa (0.5-10.3 kPa) 2 cm below and to the left of INL, and 3.8 kPa (0.4-8.8 kPa) 2 cm below and to the right of INL (p=0.4). The EtCO2 difference within each subject between hand positions with maximum and minimum values varied between individuals from 0.2 to 3.4 kPa (median 0.9 kPa). Monitoring and optimizing chest compressions using capnography was feasible. We could not demonstrate one superior hand position, but inter-individual differences suggest optimal hand position might vary significantly among patients. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  12. Asymptomatic atrial fibrillation: clinical correlates, management, and outcomes in the EORP-AF Pilot General Registry.

    PubMed

    Boriani, Giuseppe; Laroche, Cecile; Diemberger, Igor; Fantecchi, Elisa; Popescu, Mircea Ioachim; Rasmussen, Lars Hvilsted; Sinagra, Gianfranco; Petrescu, Lucian; Tavazzi, Luigi; Maggioni, Aldo P; Lip, Gregory Y H

    2015-05-01

    Atrial fibrillation is often asymptomatic, but outcomes require further characterization. The study objective was to investigate the clinical presentation, management, and outcomes in asymptomatic and symptomatic patients with atrial fibrillation who were prospectively enrolled in the EurObservational Research Programme - Atrial Fibrillation (EORP-AF) Pilot General Registry. A total of 3119 patients were enrolled, and 1237 (39.7%) were asymptomatic (European Heart Rhythm Association [EHRA] score I). Among symptomatic patients, 963 (51.2%) had mild symptoms (EHRA score II) and 919 (48.8%) had severe or disabling symptoms (EHRA III-IV). Permanent atrial fibrillation was 3-fold more common in asymptomatic patients than in symptomatic patients. On multivariate analysis, male gender (odds ratio [OR], 1.630; 95% confidence interval [CI], 1.384-1.921), older age (OR, 1.019; 95% CI, 1.012-1.026), previous myocardial infarction (OR, 1.681; 95% CI, 1.350-2.093), and limited physical activity (OR, 1.757; 95% CI, 1.495-2.064) were associated significantly with asymptomatic (EHRA I) atrial fibrillation. Fully asymptomatic atrial fibrillation (absence of current and previous symptoms) was present in 520 patients (16.7%) and was associated independently with male gender, age, and previous myocardial infarction. Appropriate guideline-based prescription of oral anticoagulants was lower in these patients, and aspirin was prescribed more frequently. Mortality at 1 year was more than 2-fold higher in asymptomatic patients compared with symptomatic patients (9.4% vs 4.2%, P < .0001) and was associated independently with older age and comorbidities, including chronic kidney disease and chronic heart failure. Asymptomatic atrial fibrillation is common in daily cardiology practice and is associated with elderly age, more comorbidities, and high thromboembolic risks. A higher 1-year mortality was found in asymptomatic patients compared with symptomatic patients. Copyright © 2015 Elsevier

  13. Prospects for pilot plants based on the tokamak, spherical tokamak and stellarator

    NASA Astrophysics Data System (ADS)

    Menard, J. E.; Bromberg, L.; Brown, T.; Burgess, T.; Dix, D.; El-Guebaly, L.; Gerrity, T.; Goldston, R. J.; Hawryluk, R. J.; Kastner, R.; Kessel, C.; Malang, S.; Minervini, J.; Neilson, G. H.; Neumeyer, C. L.; Prager, S.; Sawan, M.; Sheffield, J.; Sternlieb, A.; Waganer, L.; Whyte, D.; Zarnstorff, M.

    2011-10-01

    A potentially attractive next-step towards fusion commercialization is a pilot plant, i.e. a device ultimately capable of small net electricity production in as compact a facility as possible and in a configuration scalable to a full-size power plant. A key capability for a pilot-plant programme is the production of high neutron fluence enabling fusion nuclear science and technology (FNST) research. It is found that for physics and technology assumptions between those assumed for ITER and nth-of-a-kind fusion power plant, it is possible to provide FNST-relevant neutron wall loading in pilot devices. Thus, it may be possible to utilize a single facility to perform FNST research utilizing reactor-relevant plasma, blanket, coil and auxiliary systems and maintenance schemes while also targeting net electricity production. In this paper three configurations for a pilot plant are considered: the advanced tokamak, spherical tokamak and compact stellarator. A range of configuration issues is considered including: radial build and blanket design, magnet systems, maintenance schemes, tritium consumption and self-sufficiency, physics scenarios and a brief assessment of research needs for the configurations.

  14. Early endoscopic ultrasonography in acute biliary pancreatitis: A prospective pilot study

    PubMed Central

    Anderloni, Andrea; Galeazzi, Marianna; Ballarè, Marco; Pagliarulo, Michela; Orsello, Marco; Del Piano, Mario; Repici, Alessandro

    2015-01-01

    AIM: To investigate the clinical usefulness of early endoscopic ultrasonography (EUS) in the management of acute biliary pancreatitis (ABP). METHODS: All consecutive patients entering the emergency department between January 2010 and December 2012 due to acute abdominal pain and showing biochemical and/or radiological findings consistent with possible ABP were prospectively enrolled. Patients were classified as having a low, moderate, or high probability of common bile duct (CBD) stones, according to the established risk stratification. Exclusion criteria were: gastrectomy or patient in whom the cause of biliary obstruction was already identified by ultrasonography. All enrolled patients underwent EUS within 48 h of their admission. Endoscopic retrograde cholangiopancreatography was performed immediately after EUS only in those cases with proven CBD stones or sludge. The following parameters were investigated: (1) clinical: age, sex, fever; (2) radiological: dilated CBD; and (3) biochemical: bilirubin, AST, ALT, gGT, ALP, amylase, lipasis, PCR. Association between presence of CBD stone at EUS and the individual predictors were assessed by univariate logistic regression. Predictors significantly associated with CBD stones (P < 0.05) were entered in a multivariate logistic regression model. RESULTS: A total of 181 patients with pancreatitis were admitted to the emergency department between January 2010 and December 2012. After exclusion criteria a total of 71 patients (38 females, 53.5%, mean age 58 ± 20.12 years, range 27-89 years; 33 males, 46.5%, mean age 65 ± 11.86 years, range 41-91 years) were included in the present study. The probability of CBD stones was considered low in 21 cases (29%), moderate in 26 (37%), and high in the remaining 24 (34%). The 71 patients included in the study underwent EUS, which allowed for a complete evaluation of the target sites in all the cases. The procedure was completed in a mean time of 14.7 min (range 9-34 min), without

  15. Practical, transparent prospective risk analysis for the clinical laboratory.

    PubMed

    Janssens, Pim Mw

    2014-11-01

    Prospective risk analysis (PRA) is an essential element in quality assurance for clinical laboratories. Practical approaches to conducting PRA in laboratories, however, are scarce. On the basis of the classical Failure Mode and Effect Analysis method, an approach to PRA was developed for application to key laboratory processes. First, the separate, major steps of the process under investigation are identified. Scores are then given for the Probability (P) and Consequence (C) of predefined types of failures and the chances of Detecting (D) these failures. Based on the P and C scores (on a 10-point scale), an overall Risk score (R) is calculated. The scores for each process were recorded in a matrix table. Based on predetermined criteria for R and D, it was determined whether a more detailed analysis was required for potential failures and, ultimately, where risk-reducing measures were necessary, if any. As an illustration, this paper presents the results of the application of PRA to our pre-analytical and analytical activities. The highest R scores were obtained in the stat processes, the most common failure type in the collective process steps was 'delayed processing or analysis', the failure type with the highest mean R score was 'inappropriate analysis' and the failure type most frequently rated as suboptimal was 'identification error'. The PRA designed is a useful semi-objective tool to identify process steps with potential failures rated as risky. Its systematic design and convenient output in matrix tables makes it easy to perform, practical and transparent. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  16. The High Clinic: a pilot project of a new model for an outpatient, community-based teaching clinic in rheumatology.

    PubMed

    Almoallim, Hani; Chalmers, Andrew; Page, Gordon

    2006-12-01

    The objectives were to develop an outpatient, community-based clinical education experience for second-year rheumatology fellows based on sound education principles, and to pilot the program to test its practicability and assess student perception of its educational efficacy. The outpatient clinical education experience consisted of four steps. In Step 1 second-year rheumatology fellows assessed patients and reviewed their cases with two supervisors. Step 2 entailed each fellow presenting a brief summary of each case to their colleagues and supervisors for discussion and analysis of learning issues. In Step 3 each fellow conducted a literature search of the learning issues identified in Step 2. Step 4 occurred in the days following the clinic and entailed a seminar discussion of the literature search results with fellow colleagues. At the end of this outpatient clinical education program, questionnaires were given to participating fellows to assess its effectiveness. All participants judged this new clinical education program to be practical and effective; outcomes were positive for all skills specified as objectives for the clinic. This model of outpatient community-based clinical teaching, named 'The High Clinic' is a new and effective model for a teaching clinic in rheumatology, featuring augmented patient exposure, increased interactions with supervisors and a case-based learning. The pilot test of the clinic was implemented successfully. Participants in the clinic were satisfied with their achievement of stated objectives. This model is applicable to other specialties.

  17. Pilot Clinical Application of an Adaptive Robotic System for Young Children with Autism

    ERIC Educational Resources Information Center

    Bekele, Esubalew; Crittendon, Julie A.; Swanson, Amy; Sarkar, Nilanjan; Warren, Zachary E.

    2014-01-01

    It has been argued that clinical applications of advanced technology may hold promise for addressing impairments associated with autism spectrum disorders. This pilot feasibility study evaluated the application of a novel adaptive robot-mediated system capable of both administering and automatically adjusting joint attention prompts to a small…

  18. Pilot Clinical Application of an Adaptive Robotic System for Young Children with Autism

    ERIC Educational Resources Information Center

    Bekele, Esubalew; Crittendon, Julie A.; Swanson, Amy; Sarkar, Nilanjan; Warren, Zachary E.

    2014-01-01

    It has been argued that clinical applications of advanced technology may hold promise for addressing impairments associated with autism spectrum disorders. This pilot feasibility study evaluated the application of a novel adaptive robot-mediated system capable of both administering and automatically adjusting joint attention prompts to a small…

  19. An Occupation and Participation Approach to Reading Intervention (OPARI) Part II: Pilot Clinical Application

    ERIC Educational Resources Information Center

    Grajo, Lenin C.; Candler, Catherine

    2016-01-01

    The Occupation and Participation Approach to Reading Intervention (OPARI) is an intervention approach for children with reading difficulties that emphasizes reading as an important occupation of children. Part I presented the theoretical basis of the OPARI. Part II describes a pilot clinical application of the OPARI. Guided by Schkade and…

  20. An Occupation and Participation Approach to Reading Intervention (OPARI) Part II: Pilot Clinical Application

    ERIC Educational Resources Information Center

    Grajo, Lenin C.; Candler, Catherine

    2016-01-01

    The Occupation and Participation Approach to Reading Intervention (OPARI) is an intervention approach for children with reading difficulties that emphasizes reading as an important occupation of children. Part I presented the theoretical basis of the OPARI. Part II describes a pilot clinical application of the OPARI. Guided by Schkade and…

  1. Toward Fully Automated Multicriterial Plan Generation: A Prospective Clinical Study

    SciTech Connect

    Voet, Peter W.J.; Dirkx, Maarten L.P.; Breedveld, Sebastiaan; Fransen, Dennie; Levendag, Peter C.; Heijmen, Ben J.M.

    2013-03-01

    Purpose: To prospectively compare plans generated with iCycle, an in-house-developed algorithm for fully automated multicriterial intensity modulated radiation therapy (IMRT) beam profile and beam orientation optimization, with plans manually generated by dosimetrists using the clinical treatment planning system. Methods and Materials: For 20 randomly selected head-and-neck cancer patients with various tumor locations (of whom 13 received sequential boost treatments), we offered the treating physician the choice between an automatically generated iCycle plan and a manually optimized plan using standard clinical procedures. Although iCycle used a fixed “wish list” with hard constraints and prioritized objectives, the dosimetrists manually selected the beam configuration and fine tuned the constraints and objectives for each IMRT plan. Dosimetrists were not informed in advance whether a competing iCycle plan was made. The 2 plans were simultaneously presented to the physician, who then selected the plan to be used for treatment. For the patient group, differences in planning target volume coverage and sparing of critical tissues were quantified. Results: In 32 of 33 plan comparisons, the physician selected the iCycle plan for treatment. This highly consistent preference for the automatically generated plans was mainly caused by the improved sparing for the large majority of critical structures. With iCycle, the normal tissue complication probabilities for the parotid and submandibular glands were reduced by 2.4% ± 4.9% (maximum, 18.5%, P=.001) and 6.5% ± 8.3% (maximum, 27%, P=.005), respectively. The reduction in the mean oral cavity dose was 2.8 ± 2.8 Gy (maximum, 8.1 Gy, P=.005). For the swallowing muscles, the esophagus and larynx, the mean dose reduction was 3.3 ± 1.1 Gy (maximum, 9.2 Gy, P<.001). For 15 of the 20 patients, target coverage was also improved. Conclusions: In 97% of cases, automatically generated plans were selected for treatment because of

  2. Effects of additional team-based learning on students' clinical reasoning skills: a pilot study.

    PubMed

    Jost, Meike; Brüstle, Peter; Giesler, Marianne; Rijntjes, Michel; Brich, Jochen

    2017-07-14

    In the field of Neurology good clinical reasoning skills are essential for successful diagnosing and treatment. Team-based learning (TBL), an active learning and small group instructional strategy, is a promising method for fostering these skills. The aim of this pilot study was to examine the effects of a supplementary TBL-class on students' clinical decision-making skills. Fourth- and fifth-year medical students participated in this pilot study (static-group comparison design). The non-treatment group (n = 15) did not receive any additional training beyond regular teaching in the neurology course. The treatment group (n = 11) took part in a supplementary TBL-class optimized for teaching clinical reasoning in addition to the regular teaching in the neurology course. Clinical decision making skills were assessed using a key-feature problem examination. Factual and conceptual knowledge was assessed by a multiple-choice question examination. The TBL-group performed significantly better than the non-TBL-group (p = 0.026) in the key-feature problem examination. No significant differences between the results of the multiple-choice question examination of both groups were found. In this pilot study participants of a supplementary TBL-class significantly improved clinical decision-making skills, indicating that TBL may be an appropriate method for teaching clinical decision making in neurology. Further research is needed for replication in larger groups and other clinical fields.

  3. Sublingual Buprenorphine/Naloxone for Chronic Pain in At-Risk Patients: Development and Pilot Test of a Clinical Protocol

    PubMed Central

    Rosenblum, Andrew; Cruciani, Ricardo A.; Strain, Eric C; Cleland, Charles M.; Joseph, Herman; Magura, Stephen; Marsch, Lisa A; McNicholas, Laura F; Savage, Seddon R; Sundaram, Arun; Portenoy, Russell K.

    2013-01-01

    Objective Sublingual buprenorphine/naloxone (Bup/Nx) is approved for addiction treatment and may be useful for pain management, particularly in opioid-treated pain patients with nonadherence behaviors. The transition of opioid-treated pain patients to buprenorphine carries the risk of precipitated withdrawal and increased pain. This study convened pain and addiction specialists to develop and pilot a clinical protocol for safe transitioning to Bup/Nx. Design The protocol was revised three times based on outside expert review and pilot study observations. The pilot was conducted with a prospective cohort of 12 patients with moderate to severe chronic pain, who were receiving long-term opioid therapy with any full μ-agonist drug, and had exhibited one or more aberrant drug-related behaviors. Patients were followed up for 3 to 6 months with the expectation that they would experience few adverse events and report lower pain severity. Results The three patients on the highest baseline opioid dose (equivalent to 303–450 mg of oral morphine) and the three on the lowest doses (≤20 mg) had early adverse events (AEs) when switched to Bup/Nx and did not complete the trial. Of the remaining six, one withdrew due to AEs; one responded well, then withdrew; and four completed a three-month trial. A mixed effects model controlling for dropouts found that average and worst pain significantly decreased after the switch to Bup/Nx (both p < .01). Conclusion Based on this experience, the protocol recommends Bup/Nx for pain only when baseline opioid doses are within bounds that reduce AEs at transition and incorporates dose flexibility to further reduce risks. This protocol warrants further testing. PMID:23264315

  4. Sublingual buprenorphine/naloxone for chronic pain in at-risk patients: development and pilot test of a clinical protocol.

    PubMed

    Rosenblum, Andrew; Cruciani, Ricardo A; Strain, Eric C; Cleland, Charles M; Joseph, Herman; Magura, Stephen; Marsch, Lisa A; McNicholas, Laura F; Savage, Seddon R; Sundaram, Arun; Portenoy, Russell K

    2012-01-01

    Sublingual buprenorphine/naloxone (Bup/Nx) is approved for addiction treatment and may be useful for pain management, particularly in opioid-treated patients with pain with nonadherence behaviors. The transition of opioid-treated patients with pain to buprenorphine carries the risk of precipitated withdrawal and increased pain. This study convened pain and addiction specialists to develop and pilot a clinical protocol for safe transitioning to Bup/Nx. The protocol was revised three times based on outside expert review and pilot study observations. The pilot was conducted with a prospective cohort of 12 patients with moderate to severe chronic pain, who were receiving long-term opioid therapy with any full m-agonist drug, and had exhibited one or more aberrant drug-related behaviors. Patients were followed up for 3-6 months with the expectation that they would experience few adverse events (AEs) and report lower pain severity. The three patients on the highest baseline opioid dose (equivalent to 303-450 mg of oral morphine) and the three on the lowest doses (≤20 mg) had early AEs when switched to Bup/Nx and did not complete the trial. Of the remaining six, one withdrew due to AEs; one responded well, then withdrew; and four completed a 3-month trial. A mixed-effects model controlling for dropouts found that average and worst pain significantly decreased after the switch to Bup/Nx (both p < 0.01). Based on this experience, the protocol recommends Bup/Nx for pain only when baseline opioid doses are within bounds that reduce AEs at transition and incorporates dose flexibility to further reduce risks. This protocol warrants further testing.

  5. Prospective Pilot Investigation: Presurgical Depressive Symptom Severity and Anesthesia Response in Women Undergoing Surgery for Gynecologic Mass Removal

    PubMed Central

    Pereira, Deidre B.; Andre, Rachel; Garvan, Cynthia Wilson; Nguyen, Peter; Herman, Mary; Seubert, Christoph

    2014-01-01

    Background Anesthesia depth has been associated with mortality. The association between anesthesia depth and presurgery physical and health status, however, is currently debated. Depression is one comorbid condition that warrants investigation given its association to reduced frontal lobe activity and high prevalence in known surgery samples (e.g., gynecologic mass removal). Purpose This pilot study examined the hypothesis that severity of acute depressive symptoms would associate with greater sensitivity to anesthesia as measured by a frontal lobe electroencephalogram (EEG)-based monitor during the anesthesia induction phase among women undergoing gynecologic mass removal. Method This was a prospective and surgery anesthesia-controlled pilot investigation with 31 women undergoing surgery for removal of pelvic/gynecologic masses. Participants completed the Millon Behavioral Medicine Diagnostic (MBMD) inventory to assess depressive-related symptomatology. A Bispectral Index Score (BIS™) monitor (Aspect Medical Systems Inc., MA) was placed on the left frontal region to measure change in response from a set pre-anesthesia baseline point throughout the induction phase (6.5 min of the anesthetic). BIS™ change was calculated using a modified “area under the curve with respect to ground” formula. Results Greater sensitivity to anesthesia during induction was significantly associated with higher MBMD future pessimism scores and marginally associated with higher MBMD depression scores. Depressive personality, anxiety severity, tumor type, age, medication use, and comorbidity scores were not found to be predictors of BIS score change. Conclusion These pilot findings suggest that preoperative psychological health and anesthesia response are not independent. Acute presurgery depression and anesthesia response warrant closer empirical examination. PMID:25421878

  6. Laboratory tests to identify patients at risk of early major adverse events: a prospective pilot study.

    PubMed

    Kaufman, M; Bebee, B; Bailey, J; Robbins, R; Hart, G K; Bellomo, R

    2014-10-01

    To test whether commonly measured laboratory variables can identify surgical patients at risk of major adverse events (death, unplanned intensive care unit (ICU) admission or rapid response team (RRT) activation). We conducted a prospective observational study in a surgical ward of a university-affiliated hospital in a cohort of 834 surgical patients admitted for >24 h. We applied a previously validated multivariable model-derived risk assessment to each combined set of common laboratory tests to identify patients at risk. We compared the clinical course of such patients with that of control patients from the same ward who had blood tests but were identified as low risk. We studied 7955 batches and 73,428 individual tests in 834 patients (males 55%; average age 65.8 ± 17.6 years). Among these patients, 66 (7.9%) were identified as 'high risk'. High-risk patients were older (75.9 vs 61.8 years of age; P < 0.0001), had much greater early (48 h) mortality (6/66 (9%) vs 4/768 (0.5%); P < 0.0001) and greater overall hospital mortality (11/66 (16.7%) vs 9/768 (1.2%); P < 0.0001). They also had more early (8/66 (12.1%) vs 14/768 (1.8%); P = 0.0001) and overall in-hospital unplanned ICU admissions (12/66 (18.2%) vs 18/768 (2.3%); P < 0.0001) and more early (26/66 (39.3%) vs 50/768 (6.5%); P < 0.0001) and overall in-hospital RRT calls (26/66 (39.4%) vs 55/768 (7.2%); P < 0.0001). Commonly performed laboratory tests identify surgical ward patients at risk of early major adverse events. Further studies are needed to assess whether such identification system can be used to trigger interventions that help improve patient outcomes. © 2014 The Authors; Internal Medicine Journal © 2014 Royal Australasian College of Physicians.

  7. Clinical utility of proposed non-suicidal self-injury diagnosis--a pilot study.

    PubMed

    Odelius, Charlotta Benezeder; Ramklint, Mia

    2014-01-01

    In the forthcoming fifth revision of the Diagnostic and Statistical Manual of Mental Disorders (DSM), a new diagnosis is proposed: non-suicidal self-injury (NSSI). To test its clinical utility in a pilot study, NSSI criteria were assessed in 39 young psychiatric outpatients with self-harm behavior. There were no differences between the NSSI (n = 18) and the non-NSSI (n = 21) groups concerning other diagnoses, including borderline personality disorder (BPD) (22% vs. 24%). However, NSSI patients had more suicidal behavior than non-NSSI patients. This pilot study indicates that the NSSI diagnosis is different from BPD, but it does not delimit suicidal behavior.

  8. Radioembolization with 90Y glass microspheres for the treatment of unresectable metastatic liver disease from chemotherapy-refractory gastrointestinal cancers: final report of a prospective pilot study

    PubMed Central

    Kerlan, Robert K.; Hawkins, Randall A.; Pampaloni, Miguel; Taylor, Andrew G.; Kohi, Maureen P.; Kolli, K. Pallav; Atreya, Chloe E.; Bergsland, Emily K.; Kelley, R. Kate; Ko, Andrew H.; Korn, W. Michael; Van Loon, Katherine; McWhirter, Ryan M.; Luan, Jennifer; Johanson, Curt; Venook, Alan P.

    2016-01-01

    Background This prospective pilot single-institution study was undertaken to document the feasibility, safety, and efficacy of radioembolization of liver-dominant metastatic gastrointestinal cancer using 90Y glass microspheres. Methods Between June 2010 and October 2013, 42 adult patients (26 men, 16 women; median age 60 years) with metastatic chemotherapy-refractory unresectable colorectal (n=21), neuroendocrine (n=11), intrahepatic bile duct (n=7), pancreas (n=2), and esophageal (n=1) carcinomas underwent 60 lobar or segmental administrations of 90Y glass microspheres. Data regarding clinical and laboratory adverse events (AE) were collected prospectively for up to 5.5 years after radioembolization. Radiographic responses were evaluated using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Time to maximum response, response duration, progression-free survival (PFS) (hepatic and extrahepatic), and overall survival (OS) were measured. Results Median target dose and activity were 109.4 Gy and 2.6 GBq per treatment session, respectively. Majority of clinical AE were grade 1 or 2 in severity. Patients with colorectal cancer had hepatic objective response rate (ORR) of 25% and a hepatic disease control rate (DCR) of 80%. Median PFS and OS were 1.0 and 4.4 months, respectively. Patients with neuroendocrine tumors (NET) had hepatic ORR and DCR of 73% and 100%, respectively. Median PFS was 8.9 months for this cohort. DCR and median PFS and OS for patients with cholangiocarcinoma were 86%, 1.1 months, and 6.7 months, respectively. Conclusions 90Y glass microspheres device has a favorable safety profile, and achieved prolonged disease control of hepatic tumor burden in a subset of patients, including all patients enrolled in the neuroendocrine cohort. PMID:28078110

  9. Pilot study of an Objective Structured Clinical Examination ("the Six Pack") for evaluating clinical competencies.

    PubMed

    Franzese, Christine B

    2008-02-01

    The purpose of this study was to evaluate an Objective Structured Clinical Examination (OSCE) designed to examine all six competencies and provide meaningful results to improve resident performance. A prospective, observational study. The OSCE consists of 1 hour for examination of a simulated patient, documentation, and feedback, with 30 minutes for an evidence-based medicine (EBM) test. Eight otolaryngology residents participated. Digital recordings and written documentation were evaluated on all competencies except practice-based learning. An EBM test was scored to assess practice-based learning. Overall, senior residents scored better. Seniors scored better on performing a focused history, whereas juniors scored better for thoroughness. Seniors coded better than juniors, although seniors tended to undercode and juniors tended to overcode. Two cases of "insurance fraud" were also discovered. The "Six Pack" successfully evaluated all competencies while providing valuable information. A clinical practicum was added to improve history and physical examination skills. The discussion of coding and a billing seminar also resulted. Residents believed the OSCE was valuable. Faculty members were impressed with the useful information obtained.

  10. Utility of an Equine Clinical Skills Course: A Pilot Study.

    PubMed

    Christensen, Bruce W; Danielson, Jared A

    Recent publications have revealed inadequacies in the veterinary training of future equine practitioners. To help address this problem, a 2-week Equine Clinical Skills course was designed and implemented to provide fourth-year veterinary students with opportunities to have hands-on experience with common equine clinical skills using live animals and cadavers. Alumni and employers of alumni were surveyed to determine whether or not students participating in the course were more competent performing clinical skills during their first year post-graduation than those who had not participated in the course. Students who participated in the course were also surveyed before and after completing the course to determine whether or not their self-assessed skills improved during the course. Alumni who had taken the course rated their ability to perform the clinical skills more highly than alumni who had not taken the course. Similarly, students participating in the course indicated that they were significantly more able to perform the clinical skills after the course than when it began. Employers did not indicate a difference between the clinical skills of those who had taken the course and those who had not. Because this study involved a limited number of respondents from one institution, further studies should be conducted to replicate these findings and determine their generalizability.

  11. A Pilot Study of the Challenges and Prospects of Continuous Assessment Implementation in Nigeria

    ERIC Educational Resources Information Center

    Owolabi, Henry O.; Onuka, Adams O. U.

    2010-01-01

    This study obtained basic information from teachers and students on the challenges and prospects of implementing continuous assessment (CA) in the Nigerian school system. Secondary Schools in Ilorin, the capital city of Kwara State, located in the central region of Nigeria were sampled for use in the study. It employed survey research design…

  12. Procedures for assessing psychological predictors of injuries in circus artists: a pilot prospective study

    PubMed Central

    2014-01-01

    Background Research on psychological risk factors for injury has focused on stable traits. Our objective was to test the feasibility of a prospective longitudinal study designed to examine labile psychological states as risk factors of injury. Methods We measured psychological traits at baseline (mood, ways of coping and anxiety), and psychological states every day (1-item questions on anxiety, sleep, fatigue, soreness, self-confidence) before performances in Cirque du Soleil artists of the show “O”. Additional questions were added once per week to better assess anxiety (20-item) and mood. Questionnaires were provided in English, French, Russian and Japanese. Injury and exposure data were extracted from electronic records that are kept as part of routine business practices. Results The 43.9% (36/82) recruitment rate was more than expected. Most artists completed the baseline questionnaires in 15 min, a weekly questionnaire in <2 min and a daily questionnaire in <1 min. We improved the formatting of some questions during the study, and adapted the wording of other questions to improve clarity. There were no dropouts during the entire study, suggesting the questionnaires were appropriate in content and length. Results for sample size calculations depend on the number of artists followed and the minimal important difference in injury rates, but in general, preclude a purely prospective study with daily data collection because of the long follow-up required. However, a prospective nested case-crossover design with data collection bi-weekly and at the time of injury appears feasible. Conclusion A prospective study collecting psychological state data from subjects who train and work regularly together is feasible, but sample size calculations suggest that the optimal study design would use prospective nested case-crossover methodology. PMID:24920527

  13. Procedures for assessing psychological predictors of injuries in circus artists: a pilot prospective study.

    PubMed

    Shrier, Ian; Raglin, John S; Levitan, Emily B; Mittleman, Murray A; Steele, Russell J; Powell, Janette

    2014-06-11

    Research on psychological risk factors for injury has focused on stable traits. Our objective was to test the feasibility of a prospective longitudinal study designed to examine labile psychological states as risk factors of injury. We measured psychological traits at baseline (mood, ways of coping and anxiety), and psychological states every day (1-item questions on anxiety, sleep, fatigue, soreness, self-confidence) before performances in Cirque du Soleil artists of the show "O". Additional questions were added once per week to better assess anxiety (20-item) and mood. Questionnaires were provided in English, French, Russian and Japanese. Injury and exposure data were extracted from electronic records that are kept as part of routine business practices. The 43.9% (36/82) recruitment rate was more than expected. Most artists completed the baseline questionnaires in 15 min, a weekly questionnaire in <2 min and a daily questionnaire in <1 min. We improved the formatting of some questions during the study, and adapted the wording of other questions to improve clarity. There were no dropouts during the entire study, suggesting the questionnaires were appropriate in content and length. Results for sample size calculations depend on the number of artists followed and the minimal important difference in injury rates, but in general, preclude a purely prospective study with daily data collection because of the long follow-up required. However, a prospective nested case-crossover design with data collection bi-weekly and at the time of injury appears feasible. A prospective study collecting psychological state data from subjects who train and work regularly together is feasible, but sample size calculations suggest that the optimal study design would use prospective nested case-crossover methodology.

  14. CPTAC Prospective Biospecimen Collection Solicitation | Office of Cancer Clinical Proteomics Research

    Cancer.gov

    A new funding opportunity in support of the National Cancer Institute’s Clinical Proteomic Tumor Analysis Consortium (CPTAC) seeks to prospectively procure tumor samples, collected for proteomics investigation.

  15. Falls in the audiology clinic: a pilot study.

    PubMed

    Criter, Robin E; Honaker, Julie A

    2013-01-01

    Falls are a common and often preventable cause of injury and death among older adults. Hearing loss, vestibular disorders, dizziness, and imbalance are common risk factors for falls; however, the rate of falls among older audiology patients has never been assessed. To examine the fall history and risk factors of older adults seen in a university audiology clinic. A descriptive and correlational retrospective chart review of fall history and characteristics of patients seen in a university audiology clinic. 88 (51 women, 37 men) patients aged 60 yr and older seen in a university audiology clinic. At the time of hearing evaluation, clinic patients filled out the Activities-Specific Balance Confidence (ABC) Scale, as well as a history form containing fall-related questions. These measures, as well as demographic information (gender and age) were retrieved during a retrospective chart review. Data were analyzed with independent-samples t-tests, Pearson correlations, and descriptive statistics. Fifty percent of the study sample reported falling within the preceding 12 mo, while 70% reported having fallen at some point in the past. ABC Scale score was negatively correlated with age and number of recent falls. There appears to be a higher prevalence of falls within a university audiology clinic relative to previously published fall rates in the general population. American Academy of Audiology.

  16. Using Theater to Teach Clinical Empathy: A Pilot Study

    PubMed Central

    Leong, David; Anderson, Aaron; Wenzel, Richard P.

    2007-01-01

    Background Clinical empathy, a critical skill for the doctor–patient relationship, is infrequently taught in graduate medical education. No study has tested if clinical empathy can be taught effectively. Objective To assess whether medicine residents can learn clinical empathy techniques from theater professors. Design A controlled trial of a clinical empathy curriculum taught and assessed by 4 theater professors. Setting Virginia Commonwealth University, Richmond, Virginia, a large urban university and health system. Participants Twenty Internal Medicine residents: 14 in the intervention group, 6 in the control group. Intervention Six hours of classroom instruction and workshop time with professors of theater. Measurements Scores derived from an instrument with 6 subscores designed to measure empathy in real-time patient encounters. Baseline comparisons were made using two-sample T tests. A mixed-effects analysis of variance model was applied to test for significance between the control and intervention groups. Results The intervention group demonstrated significant improvement (p ≤ .011) across all 6 subscores between pre-intervention and post-intervention observations. Compared to the control group, the intervention group had better posttest scores in 5 of 6 subscores (p ≤ .01). Limitations The study was neither randomized nor blinded. Conclusions Collaborative efforts between the departments of theater and medicine are effective in teaching clinical empathy techniques. PMID:17486385

  17. Postoperative Albumin Drop Is a Marker for Surgical Stress and a Predictor for Clinical Outcome: A Pilot Study

    PubMed Central

    Hübner, Martin; Mantziari, Styliani; Demartines, Nicolas; Pralong, François; Coti-Bertrand, Pauline; Schäfer, Markus

    2016-01-01

    Background. Surgical stress during major surgery may be related to adverse clinical outcomes and early quantification of stress response would be useful to allow prompt interventions. The aim of this study was to evaluate the acute phase protein albumin in the context of the postoperative stress response. Methods. This prospective pilot study included 70 patients undergoing frequent abdominal procedures of different magnitude. Albumin (Alb) and C-reactive protein (CRP) levels were measured once daily starting the day before surgery until postoperative day (POD) 5. Maximal Alb decrease (Alb Δ min) was correlated with clinical parameters of surgical stress, postoperative complications, and length of stay. Results. Albumin values dropped immediately after surgery by about 10 g/L (42.2 ± 4.5 g/L preoperatively versus 33.8 ± 5.3 g/L at day 1, P < 0.001). Alb Δ min was correlated with operation length (Pearson ρ = 0.470, P < 0.001), estimated blood loss (ρ = 0.605, P < 0.001), and maximal CRP values (ρ = 0.391, P = 0.002). Alb Δ min levels were significantly higher in patients having complications (10.0 ± 5.4 versus 6.1 ± 5.2, P = 0.005) and a longer hospital stay (ρ = 0.285, P < 0.020). Conclusion. Early postoperative albumin drop appeared to reflect the magnitude of surgical trauma and was correlated with adverse clinical outcomes. Its promising role as early marker for stress response deserves further prospective evaluation. PMID:26880899

  18. An Exploration of Prospective Teachers' Learning of Clinical Interview Techniques

    ERIC Educational Resources Information Center

    Groth, Randall E.; Bergner, Jennifer A.; Burgess, Claudia R.

    2016-01-01

    The present study followed four prospective teachers through the process of learning to interview during an undergraduate research project experience. Participants conducted and video recorded a series of interviews with children. They also carried out guided analyses of the videos and written artefacts from the interviews to formulate conjectures…

  19. Development in Children with Achondroplasia: A Prospective Clinical Cohort Study

    ERIC Educational Resources Information Center

    Ireland, Penelope J.; Donaghey, Samantha; McGill, James; Zankl, Andreas; Ware, Robert S.; Pacey, Verity; Ault, Jenny; Savarirayan, Ravi; Sillence, David; Thompson, Elizabeth; Townshend, Sharron; Johnston, Leanne M.

    2012-01-01

    Aim: Achondroplasia is characterized by delays in the development of communication and motor skills. While previously reported developmental profiles exist across gross motor, fine motor, feeding, and communication skills, there has been no prospective study of development across multiple areas simultaneously. Method: This Australasian…

  20. Development in Children with Achondroplasia: A Prospective Clinical Cohort Study

    ERIC Educational Resources Information Center

    Ireland, Penelope J.; Donaghey, Samantha; McGill, James; Zankl, Andreas; Ware, Robert S.; Pacey, Verity; Ault, Jenny; Savarirayan, Ravi; Sillence, David; Thompson, Elizabeth; Townshend, Sharron; Johnston, Leanne M.

    2012-01-01

    Aim: Achondroplasia is characterized by delays in the development of communication and motor skills. While previously reported developmental profiles exist across gross motor, fine motor, feeding, and communication skills, there has been no prospective study of development across multiple areas simultaneously. Method: This Australasian…

  1. Pilot Study of a Clinical Pathway Implementation in Rectal Cancer

    PubMed Central

    Uña, Esther; López-Lara, Francisco

    2010-01-01

    Background: Rectal cancer is a highly prevalent disease which needs a multidisciplinary approach to be treated. The absence of specific protocols implies a significant and unjustifiable variability among the different professionals involved in this disease. The purpose is to develop a clinical pathway based on the analysis process and aims to reduce this variability and to reduce unnecessary costs. Methods: We created a multidisciplinary team with contributors from every clinical area involved in the diagnosis and treatment in this disease. We held periodic meetings to agree on a protocol based on the best available clinical practice guidelines. Once we had agreed on the protocol, we implemented its use as a standard in our institution. Every patient older than 18 years who was diagnosed with rectal cancer was considered a candidate to be treated via the pathway. Results: We evaluated 48 patients during the course of this study. Every parameter measured was improved after the implementation of the pathway, except the proportion of patients with 12 nodes or more analysed. The perception that our patients had about this project was very good. Conclusions: Clinical pathways are needed to improve the quality of health care. This kind of project helps reduce hospital costs and optimizes the use of limited resources. On the other hand, unexplained variability is also reduced, with consequent benefits for the patients. PMID:21151842

  2. Feasibility of NOTES Omental Plug Repair of Perforated Peptic Ulcers – Results from a Clinical Pilot Trial

    PubMed Central

    Bingener, Juliane; Loomis, Erica A.; Gostout, Christopher J.; Zielinski, Martin D.; Buttar, Navtej S.; Wong Kee Song, Louis M.; Baron, Todd H.; Ghahfarokhi, Leili Shahgholi; Rajan, Elizabeth

    2013-01-01

    Background Ulcer perforation carries up to a 30% 1-year mortality rate. Intervention-related adverse events are among statistically significant predictors of 1-year mortality. A Natural Orifice Transluminal Endoscopic Surgical (NOTES) approach may be less invasive and may decrease procedure-related adverse events by diminishing the "second hit", thus leading to decreased morbidity and mortality. Aim To assess the feasibility of an endoscopic transluminal omental plug technique in patients with perforated gastroduodenal ulcers under laparoscopic guidance. Methods Patients with suspected acute gastroduodenal ulcer perforations were offered participation in this prospective pilot study. Closure of the perforation was attempted using NOTES omental plug technique. Demographic, clinical, endoscopic and radiographic data were abstracted, as well as morbidity, mortality and pilot data regarding quality of life (QOL). Results From February 2010 through Feb 2012, 17 patients presented to a tertiary care center with clinically suspected perforated ulcer. Of seven patients (mean age 79, range 64–89) who consented to the study, three underwent the study procedure. All patients had multiple comorbidities. Two patients presented with 4–6 mm perforated peptic ulcers and underwent successful laparoscopic-assisted NOTES omental and falciform ligament patch closure, respectively. Postoperative radiographic contrast studies showed no leak and patients were discharged home on postoperative days 3 and 4. The third patient had undergone enterocutaneous fistula repair with herniorrhaphy 6 weeks prior; a transluminal endoscopic approach was feasible; however, the omentum was under too much tension to be secured. This procedure was converted to an open omental patch repair. For all but one consented patient, obtaining QOL data was feasible. Conclusion Initial results from a laparoscopic-assisted NOTES approach for closure of perforated peptic ulcers appear promising and enable swift

  3. A pilot study of distributed knowledge management and clinical decision support in the cloud.

    PubMed

    Dixon, Brian E; Simonaitis, Linas; Goldberg, Howard S; Paterno, Marilyn D; Schaeffer, Molly; Hongsermeier, Tonya; Wright, Adam; Middleton, Blackford

    2013-09-01

    Implement and perform pilot testing of web-based clinical decision support services using a novel framework for creating and managing clinical knowledge in a distributed fashion using the cloud. The pilot sought to (1) develop and test connectivity to an external clinical decision support (CDS) service, (2) assess the exchange of data to and knowledge from the external CDS service, and (3) capture lessons to guide expansion to more practice sites and users. The Clinical Decision Support Consortium created a repository of shared CDS knowledge for managing hypertension, diabetes, and coronary artery disease in a community cloud hosted by Partners HealthCare. A limited data set for primary care patients at a separate health system was securely transmitted to a CDS rules engine hosted in the cloud. Preventive care reminders triggered by the limited data set were returned for display to clinician end users for review and display. During a pilot study, we (1) monitored connectivity and system performance, (2) studied the exchange of data and decision support reminders between the two health systems, and (3) captured lessons. During the six month pilot study, there were 1339 patient encounters in which information was successfully exchanged. Preventive care reminders were displayed during 57% of patient visits, most often reminding physicians to monitor blood pressure for hypertensive patients (29%) and order eye exams for patients with diabetes (28%). Lessons learned were grouped into five themes: performance, governance, semantic interoperability, ongoing adjustments, and usability. Remote, asynchronous cloud-based decision support performed reasonably well, although issues concerning governance, semantic interoperability, and usability remain key challenges for successful adoption and use of cloud-based CDS that will require collaboration between biomedical informatics and computer science disciplines. Decision support in the cloud is feasible and may be a reasonable

  4. Intra-articular injections of HYADD4-G in male professional soccer players with traumatic or degenerative knee chondropathy. A pilot, prospective study.

    PubMed

    Tamburrino, Pasquale; Castellacci, Enrico

    2016-12-01

    Knee injuries are very common in some sports and particularly in soccer due to the highly repetitive loading of the mechanical stress involved in this practice. Knee-joint injuries account for 40% of all different kinds of lesions. Traumatic or degenerative patellofemoral or tibialfemoral chondropaties of knee cause disabling symptoms, joint pain and/or dysfunctions. The aim of the study was to evaluate the effects of HYADD4-G, a hydrogel based on a hyaluronic acid derivative, in professional soccer players affected by traumatic or degenerative knee chondropathy. Thirty male professional soccer players participants in the Italian League 2014-2015, affected by traumatic or degenerative knee patellofemoral (N.=12) or tibiofemoral (N.=18) chondropathy assessed through MRI and/or arthroscopy of knee joints and the ICRS staging (International Cartilage Repair Society ≤3a), were enrolled in this pilot prospective study. Patients underwent 2 intra-articular (IA) injections of HYADD4-G (3 mL of 8 mg/mL) at one week interval. Patients were prospectively evaluated at baseline and then at 1, 3 and 6 months after the treatment by the Osteoarthritis Outcome Score (KOOS) Score (main outcome) and by the Visual Analog Scale (VAS) to evaluate pain. A significant improvement in all clinical endpoints from pretreatment to different times of evaluation was found in all patients. ANOVA with repeated measure using the SPSS has showed significantly better results in term of KOOS and VAS scores at 1, 3 and 6 months compared to the pre-injection value (P<0.05). IA HYADD4-G is highly effective to improve resting and walking pain in professional male soccer players with traumatic or degenerative knee chondropathy.

  5. Prospective Assessment of Nocturnal Awakenings in a Case Series of Treatment-Seeking Chronic Insomnia Patients: A Pilot Study of Subjective and Objective Causes

    PubMed Central

    Krakow, Barry; Romero, Edward; Ulibarri, Victor A.; Kikta, Shara

    2012-01-01

    Background: The cause of nocturnal awakenings in patients with chronic insomnia is rarely researched. This study prospectively assessed the etiology of nocturnal awakenings (subjectively and objectively) among patients with insomnia at a private, community-based sleep medical center. Methods: Twenty adult patients with chronic insomnia enrolled between April 2008 and February 2010 met diagnostic criteria for an insomnia disorder, never previously visited a sleep specialist or underwent sleep testing, and reported no classic sleep disordered breathing symptoms. Patients completed validated scales for insomnia, sleepiness, impairment, anxiety, depression, and quality of life, a qualitative interview to assess subjective reasons for awakenings, and a diagnostic sleep study to objectively assess awakenings and their precipitants. Results: Subjective and objective data showed clinically meaningful insomnia, primarily sleep maintenance insomnia. The most common self-reported reasons for awakenings were: uncertain cause (50%), nightmares (45%), nocturia (35%), bedroom distractions (20%), or pain (15%). No patient identified breathing symptoms as a cause. Objectively, 531 awakenings were observed in the total sample, and 478 (90%) were preceded by sleep breathing events (apnea, hypopnea, or respiratory effort-related event). Fifty-three awakenings were caused by other factors (independent leg jerks [7], spontaneous [14], and sleep that was laboratory-induced [32]). Thirty awakenings ≥ 5 min—a duration sufficient to predispose toward an insomnia episode—were each preceded by a breathing event. Conclusions: Among patients with insomnia with no classic sleep breathing symptoms and therefore low probability of a sleep breathing disorder, most of their awakenings were precipitated by a medical condition (sleep disordered breathing), which contrasted sharply with their perceptions about their awakenings. Citation: Krakow B; Romero E; Ulibarri VA; Kikta S. Prospective

  6. Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database.

    PubMed

    Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M; Lössl, Kristina

    2016-03-22

    To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future.

  7. Prospective areas for development of biomedical technologies for a piloted Martian mission

    NASA Astrophysics Data System (ADS)

    Grigoriev, A. I.; Kozlovskaya, I. B.; Potapov, A. N.

    2006-07-01

    The presentation deals with the advance biomedical technologies that could be employed in a piloted mission to Mars. The idea is to use the experience of building up and utilization of orbital biomedical support systems (BMS) strengthened substantially by introduction of up-to-date technologies and equipment. Martian BMS will require development of technologies unknown in the near-Earth's orbits (artificial gravity, production greenhouse, wastes transformation). Much hope is laid on information technologies, automation of medical procedures, and telemedicine. On the phase of medical crew selection and during the mission medical examination, diagnostics and treatment should be performed with the use of advanced technologies sprung out of the discoveries of molecular biology, genomics, proteomics, and other disciplines of the modern science.

  8. [Psychometric approach of metacognition: Pilot study in clinical population].

    PubMed

    Visinet, A; Soumet-Leman, C; Baptista, A; Bungener, C; Jouvent, R

    2017-04-01

    Metacognition describes the process of thinking about one's own thought processes. This concept was introduced by Flavell in 1979 and has since been widely developed in the cognitive approach to mood and anxiety disorders. As it happens, many recent studies have underlined the links between metacognition and anxio-depressive symptoms, pointing out the interest of assessing its various dimensions. The short form of the Metacognitions Questionnaire is a brief multidimensional measure of a range of metacognitive processes and metacognitive beliefs about worry and cognition relevant to the vulnerability to and the maintenance of emotional disorders. The aim of this study was twofold: firstly to adapt and validate a French version of the short form of the Metacognitions Questionnaire (MCQ-30) and to assess its psychometric properties in a clinical sample, and secondly to investigate metacognitive predictors of anxiety and depression in this sample. The sample included 55 clinical participants (24 men, 31 women, mean age=51.33±14.62) with DSM-IV-TR psychiatric disorders (major depression, bipolar disorder and obsessive-compulsive disorder). Instrument reliability (internal consistency), construct validity (confirmatory factor analysis), and convergent validity were measured. The total score and the five subscale scores were also compared with previous results in non-clinical samples. Reliability analyses indicated that the French version of the MCQ-30 possessed satisfactory internal consistency (Cronbach α=0.84), and confirmatory factor analysis supported the MCQ's original five-factor structure. Correlation with measurements of depression, anxiety and pathological worry demonstrated convergent validity (r=0.62, P<0.01 for anxiety; r=0.47, P<0.01 for rumination; r=0.33, P<0.05 for depression). Moreover, our clinical sample scored higher on the global scale when compared to previous non-clinical samples (mean score=71.85±13.57 while previous studies global

  9. Psychosocial screening at paediatric BEEC clinics: a pilot evaluation study.

    PubMed

    Hurrell, Ruth A; Fullwood, Catherine; Keys, Joni; Dickson, Alan P; Fishwick, Janet; Whitnall, Beverley; Cervellione, Raimondo M

    2015-04-01

    Bladder Exstrophy and Epispadias Complex (BEEC) is associated with an increased risk of impaired mental health, quality of life, and psychosocial functioning. Therefore, screening patients to help identify and evaluate potential psychosocial difficulty is arguably an important consideration for BEEC Services. To screen paediatric BEEC patients for a range of general psychosocial difficulties in a multi-disciplinary out-patient clinic setting. This cross-sectional evaluation was conducted between April 2012 and July 2013. Families attending BEEC multi-disciplinary out-patient clinics were asked to complete a range of standardised psychosocial questionnaires, including the Paediatric Quality of Life Inventory (PedsQL 4.0 Generic Core and Family Impact Module), the Strengths and Difficulties Questionnaire (SDQ), the Paediatric Index of Emotional Distress (PI-ED), and the Hospital Anxiety and Depression Scale (HADS). 108 children attended clinic of which 80 (74.1%) patients and their parents/carers completed some or all of the questionnaires. The mean patient age was 8.41 years (SD = 4.46, range = 1-18 years). There were more boys (N = 50, 62.5%) and the majority had a diagnosis of classic bladder exstrophy (N = 51, 63.8%), followed by primary epispadias (N = 22, 27.5%) and cloacal exstrophy (N = 7, 8.7%). Mean total scores fell within the average/normal range on all questionnaires used (See table below). However, variation around these means was high. Age, gender and diagnosis were found to significantly influence certain questionnaire responses with older-age groups, males, and those with classic bladder exstrophy particularly at risk across some domains. The children/adolescents self-reported better health related quality of life (HRQoL) scores than published results for a range of paediatric chronic health conditions. Differences between parent and child responses on both the PedsQL and SDQ favoured a more positive response on the child self-report questionnaire

  10. [Experiences from a stress clinic. A pilot study].

    PubMed

    Netterstrøm, Bo; Bech, Per; Eller, Nanna H

    2007-01-08

    The aim of the study was to develop a multi-disciplinary stress management program for employees with long-term stress. In a two-year period, 66 people active in the labour market were referred to the stress clinic at an occupational medicine clinic. All but 10 went through the program for four months and were further evaluated after one year regarding employment, symptoms and salivary cortisol. The program consisted of 1) an evaluation of symptoms of depression and stress, 2) stress management consultations, 3) introduction to relaxation techniques and physical exercise and 4) in some cases contact to the work place for adjustments or referral to psychiatric evaluation. Physiological measures such as maximal oxygen uptake, blood pressure, cholesterol, HDL, TSH, HbA1C, fasting glucose and fibrinogen were carried out at baseline and after four months. Salivary cortisol was measured at baseline, after four months and one year. As a control group 24 people with similar symptoms referred to the Clinic of Occupational Medicine were used. A significantly larger number of people in the study group (82%) than in the control group (42%) were employed after one year. There was no difference between the two groups regarding the prevalence of stress symptoms during the follow-up period, even though the prevalence decreased significantly. However, the prevalence of depression was significantly lower after one year in the study group (4%) compared to the control group (40%). Maximum oxygen uptake increased and fibrinogen decreased significantly in four months. The rise in salivary cortisol from awakening until 30 minutes later increased significantly during one year and correlated with symptoms of depression.

  11. A framework for prospectively defining progression rules for internal pilot studies monitoring recruitment.

    PubMed

    Hampson, Lisa V; Williamson, Paula R; Wilby, Martin J; Jaki, Thomas

    2017-01-01

    Just over half of publicly funded trials recruit their target sample size within the planned study duration. When recruitment targets are missed, the funder of a trial is faced with the decision of either committing further resources to the study or risk that a worthwhile treatment effect may be missed by an underpowered final analysis. To avoid this challenging situation, when there is insufficient prior evidence to support predicted recruitment rates, funders now require feasibility assessments to be performed in the early stages of trials. Progression criteria are usually specified and agreed with the funder ahead of time. To date, however, the progression rules used are typically ad hoc. In addition, rules routinely permit adaptations to recruitment strategies but do not stipulate criteria for evaluating their effectiveness. In this paper, we develop a framework for planning and designing internal pilot studies which permit a trial to be stopped early if recruitment is disappointing or to continue to full recruitment if enrolment during the feasibility phase is adequate. This framework enables a progression rule to be pre-specified and agreed upon prior to starting a trial. The novel two-stage designs stipulate that if neither of these situations arises, adaptations to recruitment should be made and subsequently evaluated to establish whether they have been successful. We derive optimal progression rules for internal pilot studies which minimise the expected trial overrun and maintain a high probability of completing the study when the recruitment rate is adequate. The advantages of this procedure are illustrated using a real trial example.

  12. Optoacoustic monitoring of blood hemoglobin concentration: a pilot clinical study

    NASA Astrophysics Data System (ADS)

    Petrova, Irina Y.; Esenaliev, Rinat O.; Petrov, Yuriy Y.; Brecht, Hans-Peter F.; Svensen, Christer H.; Olsson, Joel; Deyo, Donald J.; Prough, Donald S.

    2005-07-01

    The optoacoustic technique is noninvasive, has high spatial resolution, and potentially can be used to measure the total hemoglobin concentration ([THb]) continuously and accurately. We performed in vitro measurements in blood and in vivo tests in healthy volunteers. Our clinical protocol included rapid infusion of intravenous saline to simulate rapid change in the [THb] during fluid therapy or surgery. Optoacoustic measurements were made from the wrist area overlying the radial artery for more than 1 h. The amplitude of the optoacoustic signal generated in the radial artery closely followed the [THb] measured directly in concurrently collected blood samples.

  13. Pilot of Direct Observation of Clinical Skills (DOCS) in a Medicine Clerkship: Feasibility and Relationship to Clinical Performance Measures

    PubMed Central

    Kang, Yoon; Bardes, Charles L.; Gerber, Linda M.; Storey-Johnson, Carol

    2009-01-01

    Purpose: To assess the feasibility of Direct Observation of Clinical Skills (DOCS), a program for formative assessment of students’ clinical skills during a medicine clerkship and to determine relationships between DOCS measures and other clinical performance measures. Method: From August, 2004 through June, 2005, Medicine Clerks assigned to the primary on-campus clinical site were asked to participate in the pilot phase of the DOCS program. Students were asked to complete at least one DOCS exercise focused on interviewing, physical examination, or oral case presentation. Results: Of the 79 students who rotated on the Medicine Clerkship during the pilot period, 79% (n = 62) participated in DOCS, and 163 forms were submitted for evaluation. Seventy-seven percent (77%) of the clinical observations occurred while on-call or during daily rounds. Seventy-three (73%) of observations were completed in 30 minutes or less. In 89% of encounters students received at least 5 minutes of verbal feedback. Satisfaction ratings from both students and observers were “moderately satisfied” or better. Global ratings from DOCS physical exam and case presentation sections were strongly correlated with both faculty ratings of clinical performance and final clerkship grade. DOCS measures were not statistically related to clerkship written examination scores. Conclusions: These data support the feasibility of the DOCS session for formative assessment of student interviewing, physical examination, and oral case presentation skills during a medicine clerkship. Observer ratings from DOCS physical examination and case presentation sections were found to be predictors of final clerkship grade. PMID:20165523

  14. Performance of a quantitative fecal immunochemical test in a colorectal cancer screening pilot program: a prospective cohort study

    PubMed Central

    Telford, Jennifer; Gentile, Laura; Gondara, Lovedeep; McGahan, Colleen; Coldman, Andrew

    2016-01-01

    Background: British Columbia undertook a colorectal cancer screening pilot program in 3 communities. Our objective was to assess the performance of 2-specimen fecal immunochemical testing in the detection of colorectal neoplasms in this population-based screening program. Methods: A prospective cohort of asymptomatic, average-risk people aged 50 to 74 years completed 2 quantitative fecal immunochemical tests every 2 years, with follow-up colonoscopy if the result of either test was positive. Participant demographics, fecal immunochemical test results, colonoscopy quality indicators and pathology results were recorded. Non-screen-detected colorectal cancer that developed in program participants was identified through review of data from the BC Cancer Registry. Results: A total of 16 234 people completed a first round of fecal immunochemical testing, with a positivity rate of 8.6%; 5378 (86.0% of eligible participants) completed a second round before the end of the pilot program, with a positivity rate of 6.7%. Of the 1756 who had a positive test result, 1555 (88.6%) underwent colonoscopy. The detection rate of colorectal cancer was 3.5 per 1000 participants. The positive predictive value of the fecal immunochemical test was 4.9% (95% confidence interval [CI] 3.8%-6.0%) for colorectal cancer, 35.0% (95% CI 32.5%-37.2%) for high-risk polyps and 62.0% (95% CI 59.6%-64.4%) for all neoplasms. The number needed to screen was 283 to detect 1 cancer, 40 to detect 1 high-risk polyp and 22 to detect any neoplasm. Interpretation: Screening every 2 years with a 2-specimen fecal immunochemical test surpassed the current benchmark for colorectal cancer detection in population-based screening. This study has implications for other jurisdictions planning colorectal cancer screening programs. PMID:28018880

  15. Performance of a quantitative fecal immunochemical test in a colorectal cancer screening pilot program: a prospective cohort study.

    PubMed

    Telford, Jennifer; Gentile, Laura; Gondara, Lovedeep; McGahan, Colleen; Coldman, Andrew

    2016-01-01

    British Columbia undertook a colorectal cancer screening pilot program in 3 communities. Our objective was to assess the performance of 2-specimen fecal immunochemical testing in the detection of colorectal neoplasms in this population-based screening program. A prospective cohort of asymptomatic, average-risk people aged 50 to 74 years completed 2 quantitative fecal immunochemical tests every 2 years, with follow-up colonoscopy if the result of either test was positive. Participant demographics, fecal immunochemical test results, colonoscopy quality indicators and pathology results were recorded. Non-screen-detected colorectal cancer that developed in program participants was identified through review of data from the BC Cancer Registry. A total of 16 234 people completed a first round of fecal immunochemical testing, with a positivity rate of 8.6%; 5378 (86.0% of eligible participants) completed a second round before the end of the pilot program, with a positivity rate of 6.7%. Of the 1756 who had a positive test result, 1555 (88.6%) underwent colonoscopy. The detection rate of colorectal cancer was 3.5 per 1000 participants. The positive predictive value of the fecal immunochemical test was 4.9% (95% confidence interval [CI] 3.8%-6.0%) for colorectal cancer, 35.0% (95% CI 32.5%-37.2%) for high-risk polyps and 62.0% (95% CI 59.6%-64.4%) for all neoplasms. The number needed to screen was 283 to detect 1 cancer, 40 to detect 1 high-risk polyp and 22 to detect any neoplasm. Screening every 2 years with a 2-specimen fecal immunochemical test surpassed the current benchmark for colorectal cancer detection in population-based screening. This study has implications for other jurisdictions planning colorectal cancer screening programs.

  16. Prognostic Importance of Lesion Location on Functional Outcome in Patients with Cerebellar Ischemic Stroke: a Prospective Pilot Study.

    PubMed

    Picelli, Alessandro; Zuccher, Paola; Tomelleri, Giampaolo; Bovi, Paolo; Moretto, Giuseppe; Waldner, Andreas; Saltuari, Leopold; Smania, Nicola

    2017-02-01

    To date, few studies focused on prediction of functional recovery after cerebellar stroke. The main aim of this prospective pilot study was to determine the association between cerebellar lesion location and functional outcome in adults with acute cerebellar infarction. We examined 14 patients with first-ever unilateral cerebellar ischemic stroke within 7 days and at 90 days from the onset of stroke by means of the International Cooperative Ataxia Rating Scale. Cerebellar lesions were traced from magnetic resonance imaging performed within 72 h since stroke and region of interest were generated. The association between the International Cooperative Ataxia Rating Scale score and lesion location was determined with the voxel-based lesion-symptom mapping methods implemented in the MRIcro software. Colored lesion-symptom maps representing the z statistics were generated and overlaid onto the MNI-ICBM 152 linear probabilistic atlas of the human brain and the Johns Hopkins University white matter templates. Our results documented that injuries to the V, VI, VIIA Crus I, VIIA Crus II, VIIB, VIIIA, and VIIIB lobules and the middle cerebellar peduncle are significantly associated with the International Cooperative Ataxia Rating Scale (ICARS) score at 1 week after the onset of stroke. Furthermore, we found that injuries to the VI, VIIA Crus I, VIIA Crus II, VIIB, VIIIA, and VIIIB lobules, the dentate nucleus, and the middle cerebellar peduncle are significantly associated with the ICARS score at 3 months since the cerebellar stroke onset. The findings of this pilot study might improve prognostic accuracy of functional outcome in patients with acute cerebellar infarction.

  17. Development and pilot testing of an objective structured clinical examination (OSCE) on hoarseness.

    PubMed

    Stewart, C Matthew; Masood, Hamid; Pandian, Vinciya; Laeeq, Kulsoom; Akst, Lee; Francis, Howard W; Bhatti, Nasir I

    2010-11-01

    To develop a valid and reliable tool for an objective structured clinical examination (OSCE) on hoarseness. To pilot-test the feasibility by assessing residents' clinical skills in various core competencies while assessing hoarseness on a standardized patient (SP). Educational tool development. The OSCE checklists were developed using modified Delphi technique after obtaining feedback from faculty involved in providing care to hoarseness patients. SP-based and rest stations were created to assess clinical skills. Twelve Otolaryngology-Head and Neck Surgery residents participated in the study. Video recordings of residents' performance and their written documentation were rated by faculty members. The OSCE that we developed is a valid method of assessing residents' clinical skills for evaluating hoarseness. Senior residents performed better in all of the tasks such as obtaining history and performing a physical exam on an SP, ability to perform flexible laryngoscopy on a mannequin, and interpretation of radiologic findings. Internal consistency assessed by Cronbach's alpha as measure of inter-item reliability was 0.92 for laryngoscopic station and 0.95 for radiology station. This OSCE can be effectively used for the objective assessment of clinical competency in hoarseness. Our pilot study evaluated multiple competencies on a single occasion, including medical knowledge, patient care, professionalism, and communication and interpersonal skills. Clinical competence in history taking, physical examination, flexible fiber-optic laryngoscopy, and ability to interpret radiologic findings improved with increasing year of training. This OSCE provides targeted assessment of practice-based learning and feedback for improvement of clinical performance.

  18. Pilot clinical trial of gabapentin to decrease postoperative delirium in older patients.

    PubMed

    Leung, J M; Sands, L P; Rico, M; Petersen, K L; Rowbotham, M C; Dahl, J B; Ames, C; Chou, D; Weinstein, P

    2006-10-10

    In this randomized pilot clinical trial, the authors tested the hypothesis that using gabapentin as an add-on agent in the treatment of postoperative pain reduces the occurrence of postoperative delirium. Postoperative delirium occurred in 5/12 patients (42%) who received placebo vs 0/9 patients who received gabapentin, p = 0.045. The reduction in delirium appears to be secondary to the opioid-sparing effect of gabapentin.

  19. Clinic-based intervention to promote literacy. A pilot study.

    PubMed

    Needlman, R; Fried, L E; Morley, D S; Taylor, S; Zuckerman, B

    1991-08-01

    Educational research has shown that children become literate more easily if their parents read to them. A clinic-based program was designed to encourage early book use among parents of children at risk. It included (1) waiting room readers, (2) guidance about literacy development, and (3) provision of children's books at each visit. Seventy-nine parents of children aged 6 to 60 months were interviewed. Parents who had previously received a book were more likely to report looking at books with their children or that looking at books was a favorite activity (adjusted odds ratio, 4.05). This association was strongest among parents receiving Aid to Families With Dependent Children (odds ratio, 7.8). This preliminary study suggests that pediatricians can play a role in enriching children's early literacy environments, especially for children at high risk of school failure.

  20. [Clinical safety audits for primary care centers. A pilot study].

    PubMed

    Ruiz Sánchez, Míriam; Borrell-Carrió, Francisco; Ortodó Parra, Cristina; Fernàndez I Danés, Neus; Fité Gallego, Anna

    2013-01-01

    To identify organizational processes, violations of rules, or professional performances that pose clinical levels of insecurity. Descriptive cross-sectional survey with customized externally-behavioral verification and comparison of sources, conducted from June 2008 to February 2010. Thirteen of the 53 primary care teams (PCT) of the Catalonian Health Institute (ICS Costa de Ponent, Barcelona). Employees of 13 PCT classified into: director, nurse director, customer care administrators, and general practitioners. Non-random selection, teaching (TC)/non-teaching, urban (UC)/rural and small/large (LC) health care centers (HCC). A total of 33 indicators were evaluated; 15 of procedures, 9 of attitude, 3 of training, and 6 of communication. Level of uncertainty: <50% positive answers for each indicator. no collaboration. A total of 55 professionals participated (84.6% UC, 46.2% LC and 76.9% TC). Rank distribution: 13 customer care administrators, 13 nurse directors, 13 HCC directors, and 16 general practitioners. Levels of insecurity emerged from the following areas: reception of new medical professionals, injections administration, nursing weekend home calls, urgent consultations to specialists, aggressive patients, critical incidents over the agenda of the doctors, communication barriers with patients about treatment plans, and with immigrants. Clinical safety is on the agenda of the health centers. Identified areas of uncertainty are easily approachable, and are considered in the future system of accreditation of the Catalonian Government. General practitioners are more critical than directors, and teaching health care centers, rural and small HCC had a better sense of security. Copyright © 2012 Elsevier España, S.L. All rights reserved.

  1. Validation of a virtual preoperative evaluation clinic: a pilot study.

    PubMed

    Zetterman, Corey V; Sweitzer, Bobbie J; Webb, Brad; Barak-Bernhagen, Mary A; Boedeker, Ben H

    2011-01-01

    Patients scheduled for surgery at the Omaha VA Medical Center were evaluated preoperatively via telemedicine. Following the examination, patients filled out a 15 item, 5 point Likert scale questionnaire regarding their opinion of preoperative evaluation in a VTC format. Evaluations were performed under the direction of nationally recognized guidelines and recommendations of experts in the field of perioperative medicine and were overseen by a staff anesthesiologist from the Omaha VA Medical Center. No significant difficulties were encountered by the patient or the evaluator regarding the quality of the audio/visual capabilities of the VTC link and its ability to facilitate preoperative evaluation. 87.5% of patients felt that virtual evaluation would save them travel time; 87.5% felt virtual evaluation could save them money; 7.3% felt uncomfortable using the VTC link; 12.2% felt the virtual evaluation took longer than expected; 70.7% preferred to be evaluated via VTC link; 21.9% were undecided; 9.7% felt they would rather be evaluated face-to-face with 26.8% undecided; 85.0% felt that teleconsultation was as good as being seen at the Omaha surgical evaluation unit; 7.5% were undecided. Our study has shown that effective preoperative evaluation can be performed using a virtual preoperative evaluation clinic; patients are receptive to the VTC format and, in the majority of cases, prefer it to face-to-face evaluation.

  2. Reliability of solar keratosis clinical diagnosis: A prospective study.

    PubMed

    Buinauskaite, Evelina; Makstiene, Jurgita; Buinauskiene, Jurate; Valiukeviciene, Skaidra

    2015-05-01

    Usually solar keratoses (SK) are diagnosed clinically. However other diseases may clinically present as erythematous macules, papules or patches on sun-exposed areas; therefore the histopathology remains the gold standard diagnostic tool. Our study, which assessed the efficacy of photodynamic therapy (PDT), showed that one in 20 clinically diagnosed SK lesions grade I-II identified by board-certified dermatologists were rosacea and only one in 40 were malignant lesions. These findings should be considered by clinicians who treat clinically diagnosed grade I-II SK without response to treatment or diagnose the recurrence of SK after PDT.

  3. Maintaining survivors' values of left ventricular power output during shock resuscitation: a prospective pilot study.

    PubMed

    Chang, M C; Meredith, J W; Kincaid, E H; Miller, P R

    2000-07-01

    Maintaining left ventricular power output (LVP) > 320 mm Hg x L/min/m2 during resuscitation has been retrospectively associated with faster resolution of acidosis and survival after posttraumatic shock. The purpose of this prospective study was to evaluate the effects of maintaining LVP above this threshold during resuscitation on base deficit clearance, organ failure, and survival. This was a study of a consecutive series of critically injured patients (PWR) monitored with a pulmonary artery catheter during initial resuscitation. LVP, calculated as cardiac index-(mean arterial pressure-central venous pressure), was maintained >320 mm Hg x L/min/m2 via a predefined protocol by using ventricular pressure-volume diagrams. Outcome was assessed by base deficit clearance (<6 mEq/L) in <24 hours, lowest base deficit in the first 24 hours after admission (24-hr base deficit), organ dysfunctions/patient, and survival. Results were compared with 39 control patients (OXY) with identical enrollment criteria from a previous prospective study who were resuscitated based on oxygen transport criteria. Twenty patients were studied over a 6-month period. Mean LVP during resuscitation in the PWR group was 360 +/- 100 mm Hg x L/min/m2. Admission base deficit was similar between the two groups (PWR 11 +/- 4.2 vs. OXY 11 +/- 5.8 mEq/L;p = 0.66). More PWR patients cleared base deficit in < 24 hours than OXY patients (16 of 20 vs. 17 of 39, p = 0.009, Fisher's exact test), and the PWR patients had a significantly lower 24-hr base deficit (3.9 +/- 3.7 vs. 7.1 +/- 4.6 mEq/L, p = 0.01). Organ dysfunction rate was lower in the PWR group (2.1 +/- 1.5 vs. 3.2 +/- 1.4 organ dysfunctions/patient, p = 0.007). Survival in the PWR group was 15 of 20, versus 21 of 39 in the OXY group (p = 0.10). Prospectively maintaining LVP above 320 mm Hg x L/min/m2 during resuscitation is an achievable goal. It is associated with improved base deficit clearance and a lower rate of organ dysfunction after

  4. Spinal posture and pelvic position during pregnancy: a prospective rasterstereographic pilot study.

    PubMed

    Betsch, Marcel; Wehrle, Regina; Dor, Larissa; Rapp, Walter; Jungbluth, Pascal; Hakimi, Mohssen; Wild, Michael

    2015-06-01

    Despite the high prevalence of low back pain during pregnancy there is still a lack in the understanding of its aetiology. Changes of the spinal posture due to the anatomical changes of the pregnant body seem to be in part responsible for the back pain. In this pilot study we assessed the potential to accurately measure the spinal posture and pelvic position during pregnancy without any harmful radiation using a spine and surface topography system. Thirteen pregnant women were examined during the second and third trimester of their pregnancy, and postpartum. Twenty female, non-pregnant volunteers comprised the control group. The spinal posture and pelvic position were measured with a radiation-free spine and surface topography system. We found a significant increase in thoracic kyphosis during the course of pregnancy, but no increased lumbar lordosis. The lateral deviation of the spine also decreased significantly. However, we did not measure significant changes of the pelvic position during or after pregnancy. The results of our study show that pregnancy has an effect on the spinal posture, and that spine and surface topography can be used to measure these changes three-dimensionally and without any harmful radiation. In future studies this technique could allow to further evaluate the relationship between posture and low back pain during pregnancy, helping to understand the aetiology of low back pain in pregnancy as well as to identify methods for its prevention and treatment.

  5. Prospective pilot trial of dexmedetomidine sedation for awake diagnostic flexible bronchoscopy.

    PubMed

    Lee, Keat; Orme, Ruari; Williams, Daryl; Segal, Reny

    2010-10-01

    Dexmedetomidine has the favorable properties of sedation, sympatholysis, analgesia, and a low risk of apnea. These properties suggest that dexmedetomidine may be useful in procedural sedation. In view of this, we conducted a pilot trial to determine the feasibility of using dexmedetomidine as a sole agent for providing sedation during awake diagnostic flexible bronchoscopy. Patients presenting for awake diagnostic flexible bronchoscopy consented to participate in a trial of dexmedetomidine sedation for the procedure. In addition to local anesthetic topicalization of the airways, dexmedetomidine was infused at 0.5 μg/kg over 10 minutes followed by an infusion of 0.2 to 0.7 μg/kg/h titrating to a Ramsay Sedation Scale score of 3. Hemodynamic parameters (heart rate, blood pressure), oxygenation status (pulse oximetry), adverse events, use of rescue sedation, and patient and proceduralist satisfaction were recorded during the trial. Five of 9 recruited patients required rescue sedation to allow the procedure to proceed. Dexmedetomidine as a sole agent at an infusion of 0.5 μg/kg over 10 minutes followed by an infusion of 0.2 to 0.7 μg/kg/h is unable to provide adequate sedation for awake diagnostic flexible bronchoscopy without the need for rescue sedation in a large proportion of patients.

  6. Assessing research impact in academic clinical medicine: a study using Research Excellence Framework pilot impact indicators

    PubMed Central

    2012-01-01

    Background Funders of medical research the world over are increasingly seeking, in research assessment, to complement traditional output measures of scientific publications with more outcome-based indicators of societal and economic impact. In the United Kingdom, the Higher Education Funding Council for England (HEFCE) developed proposals for the Research Excellence Framework (REF) to allocate public research funding to higher education institutions, inter alia, on the basis of the social and economic impact of their research. In 2010, it conducted a pilot exercise to test these proposals and refine impact indicators and criteria. Methods The impact indicators proposed in the 2010 REF impact pilot exercise are critically reviewed and appraised using insights from the relevant literature and empirical data collected for the University of Oxford’s REF pilot submission in clinical medicine. The empirical data were gathered from existing administrative sources and an online administrative survey carried out by the university’s Medical Sciences Division among 289 clinical medicine faculty members (48.1% response rate). Results The feasibility and scope of measuring research impact in clinical medicine in a given university are assessed. Twenty impact indicators from seven categories proposed by HEFCE are presented; their strengths and limitations are discussed using insights from the relevant biomedical and research policy literature. Conclusions While the 2010 pilot exercise has confirmed that the majority of the proposed indicators have some validity, there are significant challenges in operationalising and measuring these indicators reliably, as well as in comparing evidence of research impact across different cases in a standardised manner. It is suggested that the public funding agencies, medical research charities, universities, and the wider medical research community work together to develop more robust methodologies for capturing and describing impact

  7. Clinical Observed Performance Evaluation: A Prospective Study in Final Year Students of Surgery

    ERIC Educational Resources Information Center

    Markey, G. C.; Browne, K.; Hunter, K.; Hill, A. D.

    2011-01-01

    We report a prospective study of clinical observed performance evaluation (COPE) for 197 medical students in the pre-qualification year of clinical education. Psychometric quality was the main endpoint. Students were assessed in groups of 5 in 40-min patient encounters, with each student the focus of evaluation for 8 min. Each student had a series…

  8. Clinical Observed Performance Evaluation: A Prospective Study in Final Year Students of Surgery

    ERIC Educational Resources Information Center

    Markey, G. C.; Browne, K.; Hunter, K.; Hill, A. D.

    2011-01-01

    We report a prospective study of clinical observed performance evaluation (COPE) for 197 medical students in the pre-qualification year of clinical education. Psychometric quality was the main endpoint. Students were assessed in groups of 5 in 40-min patient encounters, with each student the focus of evaluation for 8 min. Each student had a series…

  9. Quantitative assessment of barriers to the clinical development and adoption of cellular therapies: A pilot study

    PubMed Central

    Rikabi, Sarah; French, Anna; Pinedo-Villanueva, Rafael; Morrey, Mark E; Wartolowska, Karolina; Judge, Andrew; MacLaren, Robert E; Mathur, Anthony; Williams, David J; Wall, Ivan; Birchall, Martin; Reeve, Brock; Atala, Anthony; Barker, Richard W; Cui, Zhanfeng; Furniss, Dominic; Bure, Kim; Snyder, Evan Y; Karp, Jeffrey M; Price, Andrew; Carr, Andrew; Brindley, David A

    2014-01-01

    There has been a large increase in basic science activity in cell therapy and a growing portfolio of cell therapy trials. However, the number of industry products available for widespread clinical use does not match this magnitude of activity. We hypothesize that the paucity of engagement with the clinical community is a key contributor to the lack of commercially successful cell therapy products. To investigate this, we launched a pilot study to survey clinicians from five specialities and to determine what they believe to be the most significant barriers to cellular therapy clinical development and adoption. Our study shows that the main concerns among this group are cost-effectiveness, efficacy, reimbursement, and regulation. Addressing these concerns can best be achieved by ensuring that future clinical trials are conducted to adequately answer the questions of both regulators and the broader clinical community. PMID:25383173

  10. When are clinical trials registered? An analysis of prospective versus retrospective registration.

    PubMed

    Harriman, Stephanie L; Patel, Jigisha

    2016-04-15

    Due to problems of publication bias and selective reporting, the ICMJE requires prospective registration of all clinical trials with an appropriate registry before the first participant is enrolled. Previous research has shown that not all clinical trials are registered at this time (prospectively). This study investigated the extent and timing of trial registration. The aims were to determine 1) the proportion of clinical trials that were registered prospectively or retrospectively and 2) when retrospective registration took place in relation to submission to the journal in which they were published. All clinical trials published in the BMC series in 2013 were identified. All articles that met the study's inclusion criteria were categorised into one of three categories: 1) prospectively registered, 2) retrospectively registered before submission to the journal in which they were published or 3) retrospectively registered after submission to the journal in which they were published. One hundred and eight eligible studies were identified. Of these, 33 (31 %) reported studies that were registered prospectively, 72 reported studies that were registered retrospectively (67 %) and three articles (3 %) did not include a trial registration number. Of the 72 studies that were registered retrospectively, 66 (92 %) were registered before the article was submitted to the journal and six (8 %) were registered after the article was submitted to the journal. Ten years after the ICMJE requirements for prospective registration of clinical trials this study found that the majority of included clinical trials were registered retrospectively but before submission to a journal for publication. This highlights the need for organisations other than journals, such as research institutions and grant giving bodies, to be more involved in enforcing prospective trial registration.

  11. A Pilot Evaluation of Portfolios for Quality Attestation of Clinical Ethics Consultants.

    PubMed

    Fins, Joseph J; Kodish, Eric; Cohn, Felicia; Danis, Marion; Derse, Arthur R; Dubler, Nancy Neveloff; Goulden, Barbara; Kuczewski, Mark; Mercer, Mary Beth; Pearlman, Robert A; Smith, Martin L; Tarzian, Anita; Youngner, Stuart J

    2016-01-01

    Although clinical ethics consultation is a high-stakes endeavor with an increasing prominence in health care systems, progress in developing standards for quality is challenging. In this article, we describe the results of a pilot project utilizing portfolios as an evaluation tool. We found that this approach is feasible and resulted in a reasonably wide distribution of scores among the 23 submitted portfolios that we evaluated. We discuss limitations and implications of these results, and suggest that this is a significant step on the pathway to an eventual certification process for clinical ethics consultants.

  12. [Changes in clinical refraction in future pilots during the course of training].

    PubMed

    Mikhaĭlova, S M; Miliavskaia, T I; Shapovalov, S L

    1994-01-01

    Changes in clinical refraction parameters were followed up in 343 students of school of pilots in the town of Burguruslan in the course of vocational training. Skiascopy and laser refractometry methods were used. Dynamic follow-up of clinical refraction showed its increase in 24.3% of the examinees both with emmetropia and hypertropia or myopia. The most noticeable increase of refraction was observed during the first two years of training, which may be explained by intensive exercise of the eyes because of theoretical studies and flights. The results evidence practical advantages of laser refractometry in comparison with skiascopy.

  13. [Prospects of cytomedines application in clinical medicine and gerontology].

    PubMed

    Morozov, V G; Khavinson, V Kh

    2000-01-01

    Available are the results of experimental and clinical study of a new class of peptide bioregulators--cytomedines. Mechanism of action of these substances is considered. Cytomedines-based drugs can be used for prevention and treatment of age pathology and premature aging. A new trend in clinical medicine--bioregulation therapy--is grounded.

  14. Alemtuzumab and sirolimus in renal transplantation: six-year results of a single-arm prospective pilot study.

    PubMed

    Sutherland, A I; Akhtar, M Z; Zilvetti, M; Brockmann, J; Ruse, S; Fuggle, S V; Sinha, S; Harden, P; Friend, P J

    2014-03-01

    mTOR inhibitors avoid calcineurin nephrotoxicity, but sirolimus de novo is associated with unacceptable side effects and higher rejection rates. We have investigated a modified strategy: alemtuzumab induction with tacrolimus and mycophenolate maintenance, switching from tacrolimus to sirolimus at 6 months and stopping mycophenolate at 12 months. Here, we report the 6-year follow-up of 30 patients prospectively recruited to this single-arm pilot study and compare outcomes to a matched contemporaneous control group of 30 patients who received standard induction and calcineurin-inhibitor-based immunosuppression.Six-year patient and graft survival were 83% and 80%(alemtuzumab) versus 77% and 70% (control). Rejection rates in the first 6 months were similar in alemtuzumab (6.6%) and control groups (10%). A higher than expected incidence of rejection in the alemtuzumab group following cessation of mycophenolate at 1 year (17%) was mitigated in later patients by retaining low dose mycophenolate. Mean eGFR was higher in the alemtuzumab group at all time points but not significantly (p¼0.16). Tacrolimus levels in the first 6 months were significantly higher in the contemporaneous control group (p<0.001). Alemtuzumab induction with initial treatment with tacrolimus enables conversion to sirolimus without the side effects and incidence of acute rejection seen in earlier protocols.

  15. Standardized diaper care regimen: a prospective, randomized pilot study on skin barrier function and epidermal IL-1α in newborns.

    PubMed

    Garcia Bartels, Natalie; Massoudy, Lida; Scheufele, Ramona; Dietz, Ekkehart; Proquitté, Hans; Wauer, Roland; Bertin, Christiane; Serrano, José; Blume-Peytavi, Ulrike

    2012-01-01

    Adaptation of skin barrier function and interleukin-1α (IL-1α) content in diapered and nondiapered skin are poorly characterized in newborns receiving standard skin care. In a monocentric, prospective pilot study 44 healthy, full-term neonates were randomly assigned to skin care with baby wipes (n = 21) or water-moistened washcloth (n = 23) at each diaper change. Transepidermal water loss (TEWL), skin hydration, skin-pH, IL-1α, and epidermal desquamation were measured on days 2, 14, and 28 postpartum. Microbiological colonization was evaluated at baseline and on day 28. Significantly lower TEWL was found on the buttock in the group using baby wipes compared to water. IL-1α and skin hydration significantly increased and pH decreased independent of skin care regimen. IL-1α was significantly higher in diapered skin compared to nondiapered skin. Although skin care with wipes seems to stabilize TEWL better than using water, the skin condition and microbiological colonization were comparable using both cleansing procedures. Increase of epidermal IL-1α may reflect postnatal skin barrier maturation. These data suggest that neither of the two cleansing procedures harms skin barrier maturation within the first four weeks postpartum. Longer observations on larger populations could provide more insight into postnatal skin barrier maturation.

  16. A clinical forensic scientist in the burns unit: necessity or not? A prospective clinical study.

    PubMed

    Yasti, Ahmet Cinar; Tumer, Ali Riza; Atli, Mesut; Tutuncu, Tanju; Derinoz, Ali; Kama, Nuri Aydin

    2006-02-01

    Child abuse by burning is a common means of assault that may be difficult to prove. Even though well trained in burns management physicians on the burn team may not be sufficiently qualified to clarify the medicolegal aspects of the incident. In Turkey, physicians have a responsibility to notify the law offices of injury to children caused by any non-accidental mechanism including neglect. The consequences of false positive and/or false negative reports to the legal offices may be damaging for the care-takers and/or the children. In our study, 239 consecutively hospitalized children with burns were studied prospectively. A clinical forensic scientist and a physician of the burns team interpreted incidents separately so that neither had an idea about the other's diagnoses until the end of the study. There were found to be some differences in the interpretation of the incidents by the clinical forensic scientist and the burns team physician. These differences were described as discordant diagnoses. The physician accepted 99 (41.4%) of the incidents as an accident while only 66 (27.6%) of the victims were labelled as accidents by the forensic scientist. A multivariate analysis identified low socioeconomic status, aged between 3 and 6 years, and a family size of more than six as independent variables significantly associated with discordant diagnoses (p = 0.0388, 0.0001, 0.0203, respectively). As a conclusion, we suggest that to minimize the likelihood of a legally inaccurate diagnosis, a clinical forensic scientist seems to be necessary in the emergency department.

  17. Simple clinical variables predict liver histology in hepatitis C: prospective validation of a clinical prediction model.

    PubMed

    Romagnuolo, Joseph; Andrews, Christopher N; Bain, Vincent G; Bonacini, Maurizio; Cotler, Scott J; Ma, Mang; Sherman, Morris

    2005-11-01

    A recent single-center multivariate analysis of hepatitis C (HCV) patients showed that having any two criteria: 1) ferritin > or =200 microg/l and 2) spider nevi and/or albumin < or = 35 g/l predicted grade 2 or greater histological inflammation; the presence of any two of the following criteria: spider nevi, platelets < or =150 x 109/l, palpable splenomegaly and/or albumin < or =35 g/l predicted stage 2 or greater histological fibrosis. Absence of predictors also predicted a lack of inflammation and fibrosis. Our aim was prospectively to validate this clinical prediction model using an independent multicenter sample. Eighty-one patients with previously untreated active chronic HCV underwent physical examination, laboratory investigation, and liver biopsy. Biopsies were read, in blinded fashion, by a single pathologist, using a modified Hytiroglou (1995) scale. The clinical scoring system was correlated with histology; likelihood ratios (LRs), Fisher's exact p-values, and receiver operating characteristics (ROCs) were calculated. Data recording was complete in 77 and 38 patients regarding fibrotic stage and inflammatory grade, respectively. For fibrosis, 3/3 patients with any three criteria (LR 17, positive predictive value (PPV) 100%), 4/5 patients with any two criteria (LR 5.1), and 15/47 with no criteria (LR 0.6, negative predictive value (NPV) 68%) had stage 2 or greater fibrosis on biopsy (p=0.01). For inflammation, 5/5 patients with both criteria (LR 15, PPV 100%), and 8/19 patients with no criteria (LR 0.5, NPV 58%) had moderate-severe inflammation on liver biopsy (p=0.036). When missing variables were assumed to be normal, recalculated LRs were almost identical. An alanine aminotransferase (ALAT) level <60 U/l may increase the NPVs. This independent multicenter data set has validated our published model which uses simple clinical variables accurately and significantly to predict hepatic fibrosis and inflammation in HCV patients.

  18. Pumpless extracorporeal interventional lung assist in patients with acute respiratory distress syndrome: a prospective pilot study.

    PubMed

    Zimmermann, Markus; Bein, Thomas; Arlt, Matthias; Philipp, Alois; Rupprecht, Leopold; Mueller, Thomas; Lubnow, Matthias; Graf, Bernhard M; Schlitt, Hans J

    2009-01-01

    Pumpless interventional lung assist (iLA) is used in patients with acute respiratory distress syndrome (ARDS) aimed at improving extracorporeal gas exchange with a membrane integrated in a passive arteriovenous shunt. In previous studies, feasibility and safety of the iLA system was demonstrated, but no survival benefit was observed. In the present pilot study we tested the hypothesis that timely initiation of iLA using clear algorithms and an improved cannulation technique will positively influence complication rates and management of lung protective ventilation. iLA was implemented in 51 patients from multiple aetiologies meeting ARDS-criteria (American-European Consensus) for more than 12 hours. Initiation of iLA followed an algorithm for screening, careful evaluation and insertion technique. Patients with cardiac insufficiency or severe peripheral vascular disease were not considered suitable for iLA. Arterial and venous cannulae were inserted using a new strategy (ultrasound evaluation of vessels by an experienced team, using cannulae of reduced diameter). The incidence of complications and the effects on tidal volumes and inspiratory plateau pressures were primary outcome parameters, while oxygenation improvement and carbon dioxide removal capabilities were secondary study parameters. Initiation of iLA resulted in a marked removal in arterial carbon dioxide allowing a rapid reduction in tidal volume (

  19. The pilot study assessing efficacy and versatility of novel therapy for neoplastic ulceration: clinical and microbiological aspects

    PubMed Central

    Tomaszewska, Elżbieta; Muszyński, Zygmunt; Ciupińska, Maria; Kotlińska-Lemieszek, Aleksandra

    2013-01-01

    Introduction Neoplastic ulcers are chronic and, most often, irreversible lesions caused by proliferation of tumor cells infiltrating and damaging skin tissues. The treatment of neoplastic ulcers is a very difficult and time-consuming process. So, is very important to find methods of controlling this type of chronic wounds. Aim To evaluate the efficiency of monitored treatment of neoplastic ulcers by means of providing moist wound environment dressings and antiseptic to the group of patients with an advanced stage of tumor, with particular focus on the impact of the treatment applied on the clinical condition of the ulcers; to evaluate the impact of the treatment applied on the dynamics of bacterial flora in neoplastic ulcers, with particular focus on the presence of alarm pathogens; to conduct a risk analysis of the occurrence of local and systemic complications during treatment. Material and methods This was a prospective pilot clinical study of 30 patients with malignant ulcers, 13 male and 17 female aged from 24 to 92 years treated with octenidine antiseptic and dressing set for 3 weeks. The wounds were clinically assessed for the changes of amount of necrotic tissue, exudate level and type, malodour and pain level during treatment. At the baseline and after 3 weeks of treatment, the wounds were swabbed for microbiological assessment. Results The used scheme of treatment is efficient and brings clinical improvement in all treated ulcers. During the 3-week treatment, reduction of necrotic tissue, decrease in the level of exudate, pain and malodour was observed in all patients (p < 0.05). High activity of octenidine against Gram(–) and Gram(+) bacteria was observed. The use of octenidine dihydrochloride correlated with a progressing eradication of multiresistant strains and alarm pathogens (p < 0.001). No serious adverse effects or significant symptoms of intolerance of the applied treatment were observed. PMID:24278081

  20. The pilot study assessing efficacy and versatility of novel therapy for neoplastic ulceration: clinical and microbiological aspects.

    PubMed

    Sopata, Maciej; Tomaszewska, Elżbieta; Muszyński, Zygmunt; Ciupińska, Maria; Kotlińska-Lemieszek, Aleksandra

    2013-08-01

    Neoplastic ulcers are chronic and, most often, irreversible lesions caused by proliferation of tumor cells infiltrating and damaging skin tissues. The treatment of neoplastic ulcers is a very difficult and time-consuming process. So, is very important to find methods of controlling this type of chronic wounds. To evaluate the efficiency of monitored treatment of neoplastic ulcers by means of providing moist wound environment dressings and antiseptic to the group of patients with an advanced stage of tumor, with particular focus on the impact of the treatment applied on the clinical condition of the ulcers; to evaluate the impact of the treatment applied on the dynamics of bacterial flora in neoplastic ulcers, with particular focus on the presence of alarm pathogens; to conduct a risk analysis of the occurrence of local and systemic complications during treatment. This was a prospective pilot clinical study of 30 patients with malignant ulcers, 13 male and 17 female aged from 24 to 92 years treated with octenidine antiseptic and dressing set for 3 weeks. The wounds were clinically assessed for the changes of amount of necrotic tissue, exudate level and type, malodour and pain level during treatment. At the baseline and after 3 weeks of treatment, the wounds were swabbed for microbiological assessment. The used scheme of treatment is efficient and brings clinical improvement in all treated ulcers. During the 3-week treatment, reduction of necrotic tissue, decrease in the level of exudate, pain and malodour was observed in all patients (p < 0.05). High activity of octenidine against Gram(-) and Gram(+) bacteria was observed. The use of octenidine dihydrochloride correlated with a progressing eradication of multiresistant strains and alarm pathogens (p < 0.001). No serious adverse effects or significant symptoms of intolerance of the applied treatment were observed.

  1. Current Status and Future Prospects of Clinical Psycholog

    PubMed Central

    Baker, Timothy B.; McFall, Richard M.; Shoham, Varda

    2010-01-01

    SUMMARY The escalating costs of health care and other recent trends have made health care decisions of great societal import, with decision-making responsibility often being transferred from practitioners to health economists, health plans, and insurers. Health care decision making increasingly is guided by evidence that a treatment is efficacious, effective–disseminable, cost-effective, and scientifically plausible. Under these conditions of heightened cost concerns and institutional–economic decision making, psychologists are losing the opportunity to play a leadership role in mental and behavioral health care: Other types of practitioners are providing an increasing proportion of delivered treatment, and the use of psychiatric medication has increased dramatically relative to the provision of psychological interventions. Research has shown that numerous psychological interventions are efficacious, effective, and cost-effective. However, these interventions are used infrequently with patients who would benefit from them, in part because clinical psychologists have not made a convincing case for the use of these interventions (e.g., by supplying the data that decision makers need to support implementation of such interventions) and because clinical psychologists do not themselves use these interventions even when given the opportunity to do so. Clinical psychologists’ failure to achieve a more significant impact on clinical and public health may be traced to their deep ambivalence about the role of science and their lack of adequate science training, which leads them to value personal clinical experience over research evidence, use assessment practices that have dubious psychometric support, and not use the interventions for which there is the strongest evidence of efficacy. Clinical psychology resembles medicine at a point in its history when practitioners were operating in a largely prescientific manner. Prior to the scientific reform of medicine in the

  2. Heart rate prediction for coronary artery disease patients (CAD): Results of a clinical pilot study.

    PubMed

    Müller-von Aschwege, Frerk; Workowski, Anke; Willemsen, Detlev; Müller, Sebastian M; Hein, Andreas

    2015-01-01

    This paper describes the results of a pilot study with cardiac patients based on information that can be derived from a smartphone. The idea behind the study is to design a model for estimating the heart rate of a patient before an outdoor walking session for track planning, as well as using the model for guidance during an outdoor session. The model allows estimation of the heart rate several minutes in advance to guide the patient and avoid overstrain before its occurrence. This paper describes the first results of the clinical pilot study with cardiac patients taking β-blockers. 9 patients have been tested on a treadmill and during three outdoor sessions each. The results have been derived and three levels of improvement have been tested by cross validation. The overall result is an average Median Absolute Deviation (MAD) of 4.26 BPM between measured heart rate and smartphone sensor based model estimation.

  3. Prospective Swiss pilot study of Endocuff-assisted colonoscopy in a screening population

    PubMed Central

    Sawatzki, Mikael; Meyenberger, Christa; Marbet, Urs Albert; Haarer, Johannes; Frei, Remus

    2015-01-01

    Background and study aims: The adenoma detection rate (ADR) is one of the quality measures in screening colonoscopy and is crucial for reducing colorectal cancer morbidity and mortality. Up to 25 % of adenomas are missed during colonoscopy. Endocuff is an easy-to-use device that is attached like a cap to the distal tip of the colonoscope in order to optimize visualization behind the folds of the colon and increase the ADR. This is the first prospective study of Endocuff-assisted colonoscopy (EC) in a screening population with follow-up to determine the ADR and adverse events of EC. Patients and methods: We prospectively enrolled asymptomatic patients referred for screening colonoscopy during the 4-month study period. We documented the Boston Bowel Preparation Scale (BBPS) score, cecal intubation rate, polyp detection rate, ADR, number of advanced adenomas, and number of adverse events. Colonoscopies were performed by five board-certified gastroenterologists. During follow-up, the patients were called 4 to 12 weeks after EC. Results: A total of 104 EC procedures were performed. Cecal intubation was achieved in 99 % of the patients, with a median intubation time of 6 minutes. The polyp detection rate and ADR in our study were 72 % and 47 %, respectively, and 13.5 % of the lesions were advanced adenomas. A significant number of adenomas were detected in the right side of the colon. Considering all the adenomas and hyperplastic polyps above the sigmoid, we recommended that nearly 60 % of our patients repeat an endoscopic follow-up according to the existing Swiss guidelines. We noted no perforations or other serious adverse events, even in the patients with extensive diverticulosis. Conclusions: EC is feasible with the most commonly available colonoscopes without severe adverse events. EC seems to be a safe and effective device for increasing the ADR, including small adenomas in the right side of the colon. Therefore, this technique may be recommended in the

  4. Embryo selection using time-lapse analysis (Early Embryo Viability Assessment) in conjunction with standard morphology: a prospective two-center pilot study.

    PubMed

    Kieslinger, Dorit C; De Gheselle, Stefanie; Lambalk, Cornelis B; De Sutter, Petra; Kostelijk, E Hanna; Twisk, Jos W R; van Rijswijk, Joukje; Van den Abbeel, Etienne; Vergouw, Carlijn G

    2016-11-01

    Does prospective embryo selection using the results from the Eava Test (Early Embryo Viability Assessment) in combination with standard morphology increase the pregnancy rate of IVF and ICSI patients compared to embryo selection based on morphology only? Embryo selection using the Eeva Test plus standard morphology on Day 3 results in comparable pregnancy rates as conventional morphological embryo selection. Time-lapse monitoring of embryo development may represent a superior way to culture and select embryos in vitro. The Eeva Test records the development of each embryo with a cell-tracking system and predicts the likelihood (High, Medium or Low) that an embryo will form a blastocyst based on an automated analysis of early cell division timings. This trial was designed as a prospective, observational, two-center pilot study with a propensity matched control group. The analysis involved 280 of 302 enrolled patients who were included in the Eeva Test group in 2013 and 560 control patients who were treated in the years 2011-2013. The majority of transfers (98%) were single embryo transfers. Two academic hospitals (VUmc Amsterdam and UZ Gent) enrolled patients <41 years old, with <3 previous attempts and ≥5 normally fertilized eggs. Propensity matching was used to identify a propensity matched control group from a cohort of 1777 patients based on age, cycle number, oocyte number and number of fertilized oocytes. There was no difference in patient baseline characteristics between the two groups. The ongoing pregnancy rate (OPR) of patients enrolled in the Eeva Test group (34.3%; 96/280) did not differ significantly from the OPR in the propensity matched control group (34.6%, 194/560; P = 0.92). However, significantly less top quality embryos (eight-cell embryos with ≤25% fragmentation) were transferred in the Eeva Test group compared to the propensity matched control group (70.4% vs. 82.3%; P < 0.001). The transfer of Eeva High and Medium embryos resulted in a

  5. Pilot prospective study of post-surgery sleep and EEG predictors of post-operative delirium.

    PubMed

    Evans, Joanna L; Nadler, Jacob W; Preud'homme, Xavier A; Fang, Eric; Daughtry, Rommie L; Chapman, Joseph B; Attarian, David; Wellman, Samuel; Krystal, Andrew D

    2017-08-01

    Delirium is a common post-operative complication associated with significant costs, morbidity, and mortality. We sought sleep/EEG predictors of delirium present prior to delirium symptoms to facilitate developing and targeting therapies. Continuous EEG data were obtained in 12 patients post-orthopedic surgery from the day of surgery until delirium assessment on post-operative day 2 (POD2). Diminished total sleep time (r=-0.68; p<0.05) and longer latency to sleep onset (r=0.67; p<0.05) on the first night in the hospital were associated with greater POD2 delirium severity. Patients experiencing delirium slept 2.4h less and took 2h longer to fall asleep. Greater waking EEG delta power (r=0.84; p<0.05) on POD1 and less non-REM sleep EEG delta power (r=-0.72; p<0.05) on night 2 also predicted POD2 delirium severity. Loss of sleep on night1 post-surgery is an early predictor of subsequent delirium. EEG Delta Power alterations in waking and sleep appear to be later indicators of impending delirium. Further work is needed to evaluate reproducibility/generalizability and assess whether sleep loss contributes to causing delirium. This first study to prospectively collect continuous EEG data for an extended period prior to delirium onset identified EEG-derived indices that predict subsequent delirium that could aid in developing and targeting therapies. Copyright © 2017. Published by Elsevier B.V.

  6. Physiotherapy Post Lumbar Discectomy: Prospective Feasibility and Pilot Randomised Controlled Trial

    PubMed Central

    Rushton, Alison; Goodwin, Peter C.

    2015-01-01

    Objectives To evaluate: acceptability and feasibility of trial procedures; distribution of scores on the Roland Morris Disability Questionnaire (RMDQ, planned primary outcome); and efficient working of trial components. Design and Setting A feasibility and external pilot randomised controlled trial (ISRCTN33808269, assigned 10/12/2012) was conducted across 2 UK secondary care outpatient physiotherapy departments associated with regional spinal surgery centres. Participants Consecutive consenting patients aged >18 years; post primary, single level, lumbar discectomy. Interventions Participants were randomised to either 1:1 physiotherapy outpatient management including patient leaflet, or patient leaflet alone. Main Outcome Measures Blinded assessments were made at 4 weeks post surgery (baseline) and 12 weeks post baseline (proposed primary end point). Secondary outcomes included: Global Perceived Effect, back/leg pain, straight leg raise, return to work/function, quality of life, fear avoidance, range of movement, medication, re-operation. Results At discharge, 110 (44%) eligible patients gave consent to be contacted. 59 (54%) patients were recruited. Loss to follow up was 39% at 12 weeks, with one site contributing 83% losses. Mean (SD) RMDQ was 10.07 (5.58) leaflet and 10.52 (5.94) physiotherapy/leaflet at baseline; and 5.37 (4.91) leaflet and 5.53 (4.49) physiotherapy/leaflet at 12 weeks. 5.1% zero scores at 12 weeks illustrated no floor effect. Sensitivity to change was assessed at 12 weeks with mean (SD) change -4.53 (6.41), 95%CI -7.61 to -1.44 for leaflet; and -6.18 (5.59), 95%CI -9.01 to -3.30 for physiotherapy/leaflet. RMDQ mean difference (95%CI) between change from baseline to twelve weeks was 1.65(-2.46 to 5.75). Mean difference (95%CI) between groups at 12 weeks was -0.16 (-3.36 to 3.04). Participant adherence with treatment was good. No adverse events were reported. Conclusions Both interventions were acceptable, and it is promising that they both

  7. Pulse oximetry with clinical assessment to screen for congenital heart disease in neonates in China: a prospective study.

    PubMed

    Zhao, Qu-ming; Ma, Xiao-jing; Ge, Xiao-ling; Liu, Fang; Yan, Wei-li; Wu, Lin; Ye, Ming; Liang, Xue-cun; Zhang, Jing; Gao, Yan; Jia, Bing; Huang, Guo-ying

    2014-08-30

    Several pioneering studies have provided evidence for the introduction of universal pulse oximetry screening for critical congenital heart disease. However, whether the benefits of screening reported in studies from high-income countries would translate with similar success to low-income countries is unknown. We assessed the feasibility and reliability of pulse oximetry plus clinical assessment for detection of major congenital heart disease, especially critical congenital heart disease, in China. We did a pilot study at three hospitals in Shanghai to assess the accuracy of pulse oximetry plus clinical assessment for detection of congenital heart disease. We made a data collection plan before recruitment. We then undertook a large, prospective, and multicentre screening study in which we screened all consecutive newborn babies (aged 6-72 h) born at 18 hospitals in China between Aug 1, 2011, and Nov 30, 2012. Newborn babies with positive screen results (either an abnormal pulse oximetry or abnormal clinical assessment) were referred for echocardiography within 24 h of screening. We identified false-negative results by clinical follow-up and parents' feedback. We calculated sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios for pulse oximetry alone, and in combination with clinical assessment, for detection of major and critical congenital heart disease. In the pilot study, 6785 consecutive newborn babies were screened; 46 of 49 (94%) cases of asymptomatic major congenital heart disease and eight of eight (100%) cases of asymptomatic critical disease were detected by pulse oximetry and clinical assessment. In the prospective multicentre study, we screened 122,738 consecutive newborn babies (120,707 asymptomatic and 2031 symptomatic), and detected congenital heart disease in 1071 (157 critical and 330 major). In asymptomatic newborn babies, the sensitivity of pulse oximetry plus clinical assessment was 93·2

  8. Lessons Learned from an ICD-10-CM Clinical Documentation Pilot Study

    PubMed Central

    Moczygemba, Jackie; Fenton, Susan H

    2012-01-01

    On October 1, 2013, the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) will be mandated for use in the United States in place of the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM). This new classification system will used throughout the nation's healthcare system for recording diagnoses or the reasons for treatment or care. A pilot study was conducted to determine whether current levels of inpatient clinical documentation provide the detail necessary to fully utilize the ICD-10-CM classification system for heart disease, pneumonia, and diabetes cases. The design of this pilot study was cross-sectional. Four hundred ninety-one de-identified records from two sources were coded using ICD-10-CM guidelines and codebooks. The findings of this study indicate that healthcare organizations need to assess clinical documentation and identify gaps. In addition, coder proficiency should be assessed prior to ICD-10-CM implementation to determine the need for further education and training in the biomedical sciences, along with training in the new classification system. PMID:22548021

  9. Clinical Profile of Leprosy Patients: A Prospective Study

    PubMed Central

    Thakkar, Sejal; Patel, Sangita V

    2014-01-01

    Introduction: Early diagnosis and early adequate drug treatment is very important aspect to reduce the load in cases of leprosy. So, correct labeling of paucibacillary and multibacillary cases is a prerequisite for the adequate treatment. Confirmation of diagnosis is an important indication for histopathological examination in doubtful cases. Objectives: The present study was carried out to know the clinical profile of leprosy patients, concordance between clinical and histopathological diagnosis in cases of leprosy, and to assess the therapeutic efficacy of antileprosy therapy. Study Design: Two hundred and fifty clinically diagnosed leprosy patients attending skin outdoor patient department (OPD) were included in the study. Slit skin smear was performed in all the cases. In that case concordance between clinical and histology can be determined only in 30 cases. All the patients were treated with MDT (multidrug therapy) as per WHO guideline. Results: A total of 250 patients attended the clinic with male to female ratio of 1.7:1. The highest incidence was noted in 17-40 years of age group. In the clinical disease spectrum, 40% patients were in the borderline spectrum followed by tuberculoid leprosy (TT) (29.2%), lepromatous leprosy (LL) (26.8%), and 3.9% of indeterminate leprosy (IL). A total of 18% of patients were of primary neuritic leprosy. A total of 8.3% patients had definite history of contact in the family or neighborhood. Clinicopathological correlation was noted in 60% of patients with maximum disparity (52.9%) in the borderline group of patients. A total of 52.8% were MB (Multibacillary) and 47.2% were PB (Paucibacillary) cases. Morphological index became negative after 6 months in all patients. Mean fall of bacteriological index after 6 months was 0.19, while after 1 year, it was 1.05. Conclusion: Timely diagnosis and adequate treatment of cases with MDT is most effective. Histopathological examination is must in doubtful cases of leprosy. PMID:24700934

  10. A prospective community-based pilot study of risk factors for the investigation of elder mistreatment.

    PubMed

    Lachs, M S; Berkman, L; Fulmer, T; Horwitz, R I

    1994-02-01

    To identify risk factors for the investigation of elder abuse, neglect, self-neglect, exploitation, and abandonment in a population-based observational cohort of community living elders. Population-based sample of 2,812 community-living men and women in New Haven, Connecticut who were over age 65 in 1982. Matching process whereby cohort members who were investigated by Connecticut's State Ombudsman on Aging in 1985 or 1986 were identified. Relative risks for ombudsman investigation in 1985 or 1986 were calculated based on risk factors status at baseline interview in 1982. Sixty-eight (2.4%) members of the cohort received investigation. Features at cohort entry significantly associated with investigation in multiple logistic regression included: requiring assistance with feeding (Adjusted OR 3.5, 95% CI 1.2, 11.7), being a minority elder (Adj. OR 2.3, 95% CI 1.4, 2.8), over age 75 at cohort inception (Adj. OR 1.9, 95% CI 1.1, 3.1), and having a poor social network as defined by a social network index (Adj. OR 1.7, 95% CI 1.0, 2.7). When stratified by race, requiring assistance with feeding was associated with ombudsman investigation in minority elders (Adj. OR 10.8, 95% CI 2.8, 40.5) but not non-minority elders (Adj. OR 1.1, 95% CI 0.5, 7.5). Functional disability, minority status, older age, and poor social networks were associated with investigation for elder mistreatment in this prospective, community-based population of men and women over the age of 65.

  11. A randomized prospective pilot trial of Web-delivered epilepsy stigma reduction communications in young adults.

    PubMed

    Sajatovic, Martha; Herrmann, Lynn K; Van Doren, Jamie R; Tatsuoka, Curtis; Welter, Elisabeth; Perzynski, Adam T; Bukach, Ashley; Needham, Kelley; Liu, Hongyan; Berg, Anne T

    2017-09-27

    Epilepsy is a common neurological condition that is often associated with stigmatizing attitudes and negative stereotypes among the general public. This randomized controlled trial (RCT) tested two new communication approaches targeting epilepsy stigma versus an education-alone approach. Two brief stigma-reduction videos were developed, informed by community stakeholder input; one highlighted role competency in people with epilepsy; the other highlighted social inclusion of people with epilepsy. A control video was also developed. A Web-based survey using a prospective RCT design compared effects of experimental videos and control on acceptability, perceived impact, epilepsy knowledge, and epilepsy stigma. Epilepsy knowledge and stigma were measured with the Epilepsy Knowledge Questionnaire (EKQ) and Attitudes and Beliefs about Living with Epilepsy (ABLE), respectively. A total of 295 participants completed the study. Mean age was 23.1 (standard deviation = 3.27) years; 59.0% were male, and 71.4% were white. Overall, respondents felt videos impacted their epilepsy attitudes. EKQ scores were similar across videos, with a trend for higher knowledge in experimental videos versus control (p = 0.06). The role competency and control videos were associated with slightly better perceived impact on attitudes. There were no differences between videos on ABLE scores (p = 0.568). There were subgroup differences suggesting that men, younger individuals, whites, and those with personal epilepsy experience had more stigmatizing attitudes. This RCT tested communication strategies to improve knowledge and attitudes about epilepsy. Although this initial effort will require follow-up, we have demonstrated the acceptability, feasibility, and potential of novel communication strategies to target epilepsy stigma, and a Web-based approach for assessing them. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

  12. Insulated-tip knife endoscopic polypectomy for difficult pedunculated colorectal polyps: a prospective pilot study.

    PubMed

    Ma, Lianjun; Zhai, Yaqi; Chai, Ningli; Li, Huikai; Yan, Li; Li, Zhenjuan; Zhang, Xiaobin; Feng, Xiuxue; Linghu, Enqiang

    2017-02-01

    Endoscopic polypectomy is widely used for colorectal polyps. However, for giant pedunculated colorectal polyps (≥3 cm), conventional techniques are so difficult with en bloc resection that patients had to be transferred to surgery. We had firstly reported our first experience with an insulated-tip knife to successfully remove a giant pedunculated polyp in the sigmoid colon. In this study, our aim was to explore safety and feasible of insulated-tip knife endoscopic polypectomy (IT-EP) for difficult pedunculated colorectal polyps. A total of seven consecutive patients with giant pedunculated colorectal polyps (≥3 cm) were prospectively enrolled. IT-EP was conducted with the help of clips for all the seven patients, and data of them was recorded and analyzed. Of seven patients, five were men and two were women with a mean age 61 years (49-72 years). The mean diameter of polyp head and stalk was 36.4 ± 4.9 mm (30-42 mm) and 14.6 ± 3.6 mm (10-20 mm), respectively. All the polyps were successfully removed with IT-EP, with a mean operation time of 14.9 ± 3.5 min (11-20 min). No serious bleeding or perforation was experienced, and no surgery was needed. There was no recurrence or residual of polyps at a mean 8.1-month follow-up. Insulated-tip knife endoscopic polypectomy is a safe and feasible alternative for difficult pedunculated colorectal polyps.

  13. Vestibular rehabilitation in elderly patients with central vestibular dysfunction: a prospective, randomized pilot study.

    PubMed

    Marioni, Gino; Fermo, Salvatore; Lionello, Marco; Fasanaro, Elena; Giacomelli, Luciano; Zanon, Stefania; Staffieri, Claudia; Dall'Igna, Franco; Manzato, Enzo; Staffieri, Alberto

    2013-12-01

    For the vestibular system, aging is associated with degenerated otoconia and loss of hair cells, vestibular afferents, and cells in the vestibular nuclei. Further neurodegenerative processes involve cortical, extrapyramidal motor, and cerebellar structures. Dizziness is quite common in the elderly, limiting their mobility and activities. The role of vestibular rehabilitation in these patients is controversial. The present prospective, randomized, preliminary investigation aimed to compare the effect of a 6-week posturography-assisted vestibular rehabilitation protocol (30 min a week) combined with a home-based exercise program (group A, 14 randomly assigned elderly patients) with the same home-based exercise program alone (group B, 14 randomly assigned elderly patients) for treating dizziness due to central vestibular dysfunction in elderly patients. The outcomes were analyzed using the 25-item Dizziness Handicap Inventory (DHI) and computerized posturography. After rehabilitation, group A scored significantly better in the DHI for the functional (p = 0.0016) and emotional (p = 0.01) domains and total score (p = 0.001); only the emotional domain improved significantly in group B (p = 0.038). Group A improved significantly in some posturographic parameters in the motor tests (reaction time, movement velocity, and endpoint excursion), while group B experienced more limited improvements. Our preliminary results with a program of posturography-assisted vestibular rehabilitation, and home-based exercises are more promising than with home-based exercises alone. A new study on a larger series of elderly patients with central vestibular dysfunctions is currently underway at Padova University, considering the effect of a protocol involving rehabilitation with computerized posturography alone and the relationship between outcomes and the duration of rehabilitation programs.

  14. Prospective pilot study of CT-guided microwave ablation in the treatment of osteoid osteomas.

    PubMed

    Prud'homme, Clara; Nueffer, Jean-Philippe; Runge, Michel; Dubut, Jonathan; Kastler, Bruno; Aubry, Sébastien

    2017-03-01

    The aims of this work were to assess the feasibility and efficacy of CT-guided microwave ablation (MWA) in the treatment of osteoid osteomas (OOs). Thirteen consecutive patients (range 11-31 years old) presenting with OO were prospectively included and treated by CT-guided MWA. Power and duration of MWA were both recorded. The patient's pain was assessed using a numeric pain rating scale (NRS), and side effects were recorded during procedures, after 1 day, 7 days and 1 month. The nidus vascularization and the volume of necrosis induced by MWA were assessed using contrast-enhanced MRI. Success was defined as the complete relief of the patient's pain 1 month after the first procedure, associated with necrosis of the nidus on follow-up MRI. The success rate was up to 92.3% (12/13). At 1 day, 7 days and 1 month, the median NRSs were respectively 5 [interquartile range (IQR) 2-5], 0 (IQR 0-1) and 0 (IQR 0-0). Side effects observed were one partial and self-resolving lesion of a sensory branch of the radial nerve and two skin burns. The median power of the MWA used was 60 W (IQR 50-60) with a 1.5-min duration (IQR 1-2), leading to MWA-induced necrosis measuring on average 23 × 15 × 16 mm. CT-guided MWA of OO has a success rate that appears to be almost similar to that of laser or radiofrequency ablation, but care must be taken to prevent nerve or skin lesions.

  15. Drainage of esophageal leakage using endoscopic vacuum therapy: a prospective pilot study.

    PubMed

    Ahrens, M; Schulte, T; Egberts, J; Schafmayer, C; Hampe, J; Fritscher-Ravens, A; Broering, D C; Schniewind, B

    2010-09-01

    Major leakage from an esophageal anastomosis is a life-threatening surgical complication. Endoscopically guided endoluminal vacuum therapy using polyurethane sponges is a new method for treating such leakage. Between June 2007 and June 2009, five patients (mean age 68 years) who developed anastomotic leakage after esophageal surgery were prospectively evaluated. After endoscopic diagnosis of a major leakage, polyurethane sponges were endoscopically positioned in the wound cavity of the anastomosis. Continuous suction was applied via drainage tubes fixed to the sponges. Initially sponges were endoscopically changed three times per week. In all five patients treatment was successful. Median time to reduce levels of inflammation markers by 50 % was 10 days for white blood cell (WBC) count and 7 days for C-reactive protein (CRP). The smallest initial wound cavity size was 42 cm (3) and the largest was 157 cm (3). The median duration of drainage was 28 days, with a median of 9 sponge changes and a median time to total cavity closure of 42 days. Two patients needed anastomotic dilation by Savary-Miller bougienage due to stenosis found on further follow-up. One of these patients died of acute severe hemorrhage from an aortoanastomotic fistula after the dilation procedure. Endoscopically assisted vacuum therapy is a well-tolerated and effective therapeutic option for treatment of major esophageal leaks after surgery. Additional surgery was avoided in all cases. However, the occurrence of a delayed aortoesophageal fistula calls for careful further investigation of this new technique. Copyright Georg Thieme Verlag KG Stuttgart . New York.

  16. Therapeutic horticulture in clinical depression: a prospective study.

    PubMed

    Gonzalez, Marianne Thorsen; Hartig, Terry; Patil, Grete Grindal; Martinsen, Egil W; Kirkevold, Marit

    2009-01-01

    Clinically depressed persons suffer from impaired mood and distortion of cognition. This study assessed changes in depression severity and perceived attentional capacity of clinically depressed adults (N=18) during a 12-week therapeutic horticulture program. The Beck Depression Inventory (BDI) and Attentional Function Index (AFI) were administered at baseline, twice during (4 and 8 weeks), and immediately after the intervention (12 weeks), and at a 3-month follow-up. Experiences of being away and fascination related to the intervention were measured at 4, 8, and 12 weeks. The mean BDI score declined 9.7 points from pretest (27.3) to posttest (p < .001) and were clinically relevant (deltaBDI > or =6) for 72% of the cases. The mean AFI score increased 10.2 points from pretest (68.8) to posttest (p = .06). The greatest change in BDI and AFI scores occurred in the initial weeks of the intervention. The reduction in BDI scores remained significant and clinically relevant at the 3-month follow-up (N=16). The decline in depression severity during the intervention correlated strongly with the degree to which the participants found that it captured their attention. Therapeutic horticulture may decrease depression severity and improve perceived attentional capacity by engaging effortless attention and interrupting rumination.

  17. Performance of zirconia ceramic cantilever fixed dental prostheses: 3-year results from a prospective, randomized, controlled pilot study.

    PubMed

    Zenthöfer, Andreas; Ohlmann, Brigitte; Rammelsberg, Peter; Bömicke, Wolfgang

    2015-07-01

    Little is known about the clinical performance of ceramic cantilever fixed dental prostheses on natural teeth. The purpose of this randomized controlled pilot study was to evaluate the clinical performance of ceramic and metal ceramic cantilever fixed dental prostheses (CFDPs) after 3 years of service. Twenty-one participants were randomly allocated to 2 treatment groups. Participants in the ceramic (ZC) group (n=11) each received 1 CFDP made of yttria-stabilized, tetragonal zirconia polycrystal; the others (n=10) were fitted with a metal ceramic (MC) CFDP. All CFDPs were retained by 2 complete crown abutments and replaced 1 tooth. The clinical target variables were survival, incidence of complications, probing pocket depth (PPD), probing attachment level (PAL), plaque index (PI), gingival index (GI), and esthetic performance as rated by the participants. The United States Public Health Service (USPHS) criteria were used to evaluate chipping, retention, color, marginal integrity, and secondary caries. Descriptive statistics and nonparametric analyses were applied to the target variables in the 2 groups. The esthetic performance of the CFDPs was also visualized by using a pyramid comparison. The overall survival of the CFDPs was 100% in both groups. During the 3-year study, 6 clinically relevant complications requiring aftercare were observed among 5 participants (4 in the ZC group and 2 in the MC group). Changes in the PI, GI, PPD, and PAL of the abutment teeth were similar for both groups (P>.05). The participants regarded the esthetic performance of ZC-CFDPs and MC-CFDPs as satisfactory. Within the 3-year observation period, the clinical performance of MC-FDPs and ZC-FDPs was acceptable. More extensive research with larger sample sizes is encouraged, however, to confirm the evaluation of the survival of Y-TZP hand-veneered cantilever FPDs. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  18. Prospective open-label clinical trial of trihexyphenidyl in children with secondary dystonia due to cerebral palsy.

    PubMed

    Sanger, Terence D; Bastian, Amy; Brunstrom, Jan; Damiano, Diane; Delgado, Mauricio; Dure, Leon; Gaebler-Spira, Deborah; Hoon, Alec; Mink, Jonathan W; Sherman-Levine, Sara; Welty, Leah J

    2007-05-01

    Although trihexyphenidyl is used clinically to treat both primary and secondary dystonia in children, limited evidence exists to support its effectiveness, particularly in dystonia secondary to disorders such as cerebral palsy. A prospective, open-label, multicenter pilot trial of high-dose trihexyphenidyl was conducted in 23 children aged 4 to 15 years with cerebral palsy judged to have secondary dystonia impairing function in the dominant upper extremity. All children were given trihexyphenidyl at increasing doses over a 9-week period up to a maximum of 0.75 mg/kg/d. Trihexyphenidyl was subsequently tapered off over the next 5 weeks. Objective motor assessments were performed at baseline, 9 weeks, and 15 weeks. The primary outcome measure was the Melbourne Assessment of Unilateral Upper Limb Function, tested in the dominant arm. Tolerability and safety were monitored closely throughout the trial. Of the 31 children who agreed to participate in the study, 5 failed to meet entry criteria and 3 withdrew due to nonserious adverse events (chorea, drug rash, and hyperactivity). Three children required a dosage reduction because of nonserious adverse events but continued to participate. The 23 children who completed the study showed a significant improvement in arm function at 15 weeks (P = .045) but not at 9 weeks (P = .985). Post hoc analysis showed that a subgroup (n = 10) with hyperkinetic dystonia (excess involuntary movements) worsened at 9 weeks (P = .04) but subsequently returned to baseline following taper of the medicine. The authors conclude that scientific evidence for the clinical use of trihexyphenidyl in cerebral palsy remains equivocal. Trihexyphenidyl may be a safe and effective for treatment for arm dystonia in some children with cerebral palsy if given sufficient time to respond to the medication. Post hoc analyses based on the type of movement disorder suggested that children with hyperkinetic forms of dystonia may worsen. A larger, randomized

  19. A prospective pilot study to evaluate an animated home-based physical exercise program as a treatment option for patients with rheumatoid arthritis.

    PubMed

    Zernicke, Jan; Kedor, Claudia; Müller, Angela; Burmester, Gerd-Rüdiger; Reißhauer, Anett; Feist, Eugen

    2016-08-18

    Physical exercises and physiotherapy are of great importance for maintenance of joint function in patients with rheumatoid arthritis (RA). However, many RA patients complain about problems to receive prescriptions or have a lack of access to physiotherapy. Recent reports have shown positive effects of the Wii game console on physical and psychosocial conditions of patients with other underlying diseases. The primary objectives of this prospective controlled pilot study were to investigate feasibility and patients' assessment using an animated home-based exercise program. This pilot study was conducted as a single-center, cross-over trial with two treatment arms over 24 weeks. Eligibility criteria included patients with RA reaching low disease activity under therapy with a biological disease modifying anti-rheumatic drug (bDMARD). After detailed instruction, 15 patients started with a conventional home-based physical exercise program and 15 patients began with a predefined animated exercise program by using the Wii game console for 12 weeks. Afterwards, patients were crossed-over to the other treatment arm for another period of 12 weeks. Multi-methodical assessments were performed by qualitative analysis of the interview-data as well as statistical analysis of functional tests and patient reported outcomes (PRO's). Evaluation of the interviews indicated feasibility and usefulness of the chosen animated home-based exercise program. Forefoot disabilities were identified as a main limiting factor for performing some of the animated exercises. After 12 weeks, both treatment arms showed improvement of functional tests without significant differences between groups: Overall muscle strength improved for a mean value of 10 Newton (+12 %) and the mean 6-min walk test (6-MWT) distance increased for 28 meters (+5 %). This study showed that an animated home-based exercise program by using a Wii game console was feasible and beneficial for RA patients. Compared to standard

  20. An international prospective cohort study evaluating major vascular complications among patients undergoing noncardiac surgery: the VISION Pilot Study

    PubMed Central

    2011-01-01

    Objectives Among patients undergoing noncardiac surgery, our objectives were to: (1) determine the feasibility of undertaking a large international cohort study; (2) estimate the current incidence of major perioperative vascular events; (3) compare the observed event rates to the expected event rates according to the Revised Cardiac Risk Index (RCRI); and (4) provide an estimate of the proportion of myocardial infarctions without ischemic symptoms that may go undetected without perioperative troponin monitoring. Design An international prospective cohort pilot study. Participants Patients undergoing noncardiac surgery who were > 45 years of age, receiving a general or regional anesthetic, and requiring hospital admission. Measurements Patients had a Roche fourth-generation Elecsys troponin T measurement collected 6 to 12 hours postoperatively and on the first, second, and third days after surgery. Our primary outcome was major vascular events (a composite of vascular death [i.e., death from vascular causes], nonfatal myocardial infarction, nonfatal cardiac arrest, and nonfatal stroke) at 30 days after surgery. Our definition for perioperative myocardial infarction included: (1) an elevated troponin T measurement with at least one of the following defining features: ischemic symptoms, development of pathologic Q waves, ischemic electrocardiogram changes, coronary artery intervention, or cardiac imaging evidence of myocardial infarction; or (2) autopsy findings of acute or healing myocardial infarction. Results We recruited 432 patients across 5 hospitals in Canada, China, Italy, Colombia, and Brazil. During the first 30 days after surgery, 6.3% (99% confidence interval 3.9–10.0) of the patients suffered a major vascular event (10 vascular deaths, 16 nonfatal myocardial infarctions, and 1 nonfatal stroke). The observed event rate was increased 6-fold compared with the event rate expected from the RCRI. Of the 18 patients who suffered a myocardial infarction

  1. [ARMOR: an electromechanical robot for upper limb training following stroke. A prospective randomised controlled pilot study].

    PubMed

    Mayr, A; Kofler, M; Saltuari, L

    2008-02-01

    Due to the complexity of the upper motor neuron syndrome, functional improvement in the paretic upper limb after stroke continues to be a challenge in neurorehabilitation. Robot-assisted training has been shown to be useful in relearning gait. In order to achieve similar results in the upper limb, an electromechanical arm robot (ARMOR), capable of moving all joints through complex patterns, has been developed. Eight patients following stroke of different etiologies were included in a clinical AB-BA cross-over study comparing ARMOR training with EMG-triggered neuromuscular electrical stimulation (EMG-NMES). Chedoke-McMaster Stroke Assessment, modified Ashworth Scale, goniometry (Neutral-0-Method), dynamometry and Functional Dexterity Test served as outcome measures. ARMOR training resulted in more improvement of muscle tone (p = 0.004), range of movement (ROM) (p = 0.005) and dexterity, but less improvement of strength, than EMG-NMES. Chedoke-McMaster Stroke Assessment showed improvement of at least one point in shoulder pain and arm and hand activity during ARMOR training, while these values did not change with EMG-NMS. Better results of ARMOR training were achieved in the earlier phase (A1) than in the later phase (A2). This study demonstrates the positive effect of automatised training with a new electromechanical arm robot (ARMOR), and documents its clinical applicability in the rehabilitation of the paretic upper extremity in stroke patients.

  2. Clinical impact of 8 prospective, randomized, multicenter glaucoma trials.

    PubMed

    Panarelli, Joseph F; Banitt, Michael R; Sidoti, Paul A; Budenz, Donald L; Singh, Kuldev

    2015-01-01

    To determine the impact of 8 multicenter randomized clinical trials (RCTs) on glaucoma practice. An electronic survey was distributed to the members of the American Glaucoma Society (AGS). Each participant was asked 2 study-specific questions and 1 standard question common to all 8 RCTs assessing the study's impact on clinical practice. RCTs included in the survey were the Advanced Glaucoma Intervention Study (AGIS), Collaborative Initial Glaucoma Treatment Study (CIGTS), Collaborative Normal Tension Glaucoma (CNTG) Study, European Glaucoma Prevention Study (EGPS), Early Manifest Glaucoma Trial (EMGT), Glaucoma Laser Trial (GLT), Ocular Hypertension Treatment Study (OHTS), and Tube Versus Trabeculectomy (TVT) Study. A 5-point Likert scale was used for rating all responses. The practice setting and duration of glaucoma practice was determined for all AGS members who responded. A total of 206 (23.0%) of 894 AGS members participated in the survey. Among those who responded, 46.4% were self classified as academic practitioners and 53.6% worked in a private practice setting. Mean Likert scores for the standard question evaluating the overall impact of the RCT were OHTS 4.47, CNTG Study 4.13, AGIS 3.78, TVT Study 3.53, EMGT 3.48, CIGTS 3.44, GLT 3.39, and 2.69 EGPS. Substantial differences were observed in the clinical impact of several RCTs in glaucoma. The reported impact of each study likely reflects several factors including study timing, design, conduct, and interpretation of results.

  3. Panax ginseng therapy for chronic obstructive pulmonary disease: a clinical trial protocol and pilot study

    PubMed Central

    2014-01-01

    Background Panax ginseng (Ren shen) has been used to treat chronic obstructive pulmonary disease (COPD). This article aims to present a study protocol and pilot trial comparing P. ginseng with placebo for treating moderate to very severe COPD. Methods COPD was diagnosed spirometrically, with participants having a forced expiratory volume in one second (FEV1) of between 20% and 79% and FEV1 to forced vital capacity (FVC) ratio of less than 70%. Outcome measures included exacerbation rate, St. Georges Respiratory Questionnaire, COPD Assessment Test and Short-form Health Survey (SF-36). Other outcome measures included the six-minute walk test, FEV1, FVC, relief medication use, use of COPD-specific medical resources, and adverse events. The study is a randomized, double-blind, placebo controlled clinical trial. The method of this pilot trial was based on a planned full-scale trial except that participants were enrolled for ten weeks compared to 52 weeks. In the pilot trial, 14 participants (57–73 years old) with moderate to very severe COPD were recruited from a community health program at a public Chinese medicine hospital in Guangdong Province, China. After a 2-week run-in period, 10 participants were eligible for the study and were randomly assigned to either P. ginseng group (n = 5) (200 mg twice daily for four weeks) or placebo group (n = 5), and then followed-up for an additional 4 weeks for a total of 10 weeks. Results Nine participants completed the trial and one dropped out. The exacerbation rate could not be evaluated because there were no exacerbations. One participant in P. ginseng group reported events of sore throat, cough and fever. Trial investigators did not consider these events as COPD exacerbations or adverse events. Conclusions Participant recruitment, study design, data collection and outcome measurement have been tested in a pilot trial. A full-scale trial is warranted. PMID:25161696

  4. Three-month treatment with triptorelin, letrozole and ulipristal acetate before hysteroscopic resection of uterine myomas: prospective comparative pilot study.

    PubMed

    Bizzarri, Nicolò; Ghirardi, Valentina; Remorgida, Valentino; Venturini, Pier Luigi; Ferrero, Simone

    2015-09-01

    To compare the usefulness of preoperative treatment with triptorelin, letrozole or ulipristal acetate or no treatment before hysteroscopic removal of uterine submucosal myomas. Single center prospective non-randomized comparative pilot study. The study included consecutive premenopausal patients undergoing hysteroscopic resection of myomas graded as type 0, type 1 or type 2 according to the FIGO classification with diameter between 20 and 35 mm. Exclusion criteria were: associated polyps, associated non-hysteroscopic surgical procedures, >2 myomas requiring hysteroscopic resection. This study enrolled patients who underwent either direct surgery (group S; n=23) or 3-month preoperative treatment with triptorelin (3.75 mg every 28 days; group T; n=20), letrozole (2.5 mg/day; group L; n=11) or ulipristal acetate (5 mg/day; group U; n=7). Patients underwent hysteroscopic resection of the myomas. All medical treatments caused a significant decrease in the volume of myomas (group T, p<.001; group L, p<.001; group U, p=.006); however, the percentage decrease in myoma volume was lower in group U than in group T (p=.001) and in group L (p=.010). The hysteroscopy time was higher in group S than in group T (p<.001) and in group L (p=.001); there was no significant difference in the hysteroscopy time between group S and group U (p=.206). Fluid absorption was lower in group T than in group S (p=.002) and in group L than in group S (p=.048); fluid absorption was similar in group S and group U (p=.110). Intra- and postoperative complications, postoperative pain, and patient satisfaction were similar in the four study groups. Surgeon's evaluation of operative difficulty was better in group T than in group S (p<.005). Preoperative treatment with triptorelin and letrozole decreases the hysteroscopy time and the volume of fluid absorbed during hysteroscopic resection of uterine submucosal myomas. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  5. A training approach to improve stepping automaticity while dual-tasking in Parkinson's disease: A prospective pilot study.

    PubMed

    Chomiak, Taylor; Watts, Alexander; Meyer, Nicole; Pereira, Fernando V; Hu, Bin

    2017-02-01

    Deficits in motor movement automaticity in Parkinson's disease (PD), especially during multitasking, are early and consistent hallmarks of cognitive function decline, which increases fall risk and reduces quality of life. This study aimed to test the feasibility and potential efficacy of a wearable sensor-enabled technological platform designed for an in-home music-contingent stepping-in-place (SIP) training program to improve step automaticity during dual-tasking (DT). This was a 4-week prospective intervention pilot study. The intervention uses a sensor system and algorithm that runs off the iPod Touch which calculates step height (SH) in real-time. These measurements were then used to trigger auditory (treatment group, music; control group, radio podcast) playback in real-time through wireless headphones upon maintenance of repeated large amplitude stepping. With small steps or shuffling, auditory playback stops, thus allowing participants to use anticipatory motor control to regain positive feedback. Eleven participants were recruited from an ongoing trial (Trial Number: ISRCTN06023392). Fear of falling (FES-I), general cognitive functioning (MoCA), self-reported freezing of gait (FOG-Q), and DT step automaticity were evaluated. While we found no significant effect of training on FES-I, MoCA, or FOG-Q, we did observe a significant group (music vs podcast) by training interaction in DT step automaticity (P<0.01). Wearable device technology can be used to enable musically-contingent SIP training to increase motor automaticity for people living with PD. The training approach described here can be implemented at home to meet the growing demand for self-management of symptoms by patients.

  6. Disordered Eating Behaviors in Youth with Type 1 Diabetes: Prospective Pilot Assessment Following Initiation of Insulin Pump Therapy

    PubMed Central

    Markowitz, Jessica T.; Alleyn, Cielo A.; Phillips, Roxanne; Muir, Andrew; Young-Hyman, Deborah

    2013-01-01

    Abstract Background There is risk for disordered eating behaviors in type 1 diabetes, especially related to insulin manipulation. Implementation of insulin pump therapy may encourage either normalization of eating behaviors or a greater focus on food intake due to renewed emphasis on carbohydrate counting. There is need for prospective studies to assess disordered eating behaviors upon implementation of pump therapy using diabetes-specific measurement tools. Subjects and Methods In a multicenter pilot study, 43 youth with type 1 diabetes, 10–17 years old, were assessed prior to pump initiation and after 1 and 6 months of pump therapy. Youth completed the Diabetes-specific Eating Problems Survey-Revised (DEPS-R), a validated measure of risk for both diabetes-specific and general disordered eating behaviors. Results Youth (45% female), 13.3 years old with diabetes for 2.1 years, had a mean hemoglobin A1c of 8.3±1.3% (68±14.5 mmol/mol) at baseline. DEPS-R scores decreased over time (P=0.01). Overall rate of high risk for eating disorders was low. Overweight/obese youth endorsed more disordered eating behaviors than normal-weight participants. DEPS-R scores were correlated with z-score for body mass index at all three time points and with hemoglobin A1c after 1 and 6 months. Hemoglobin A1c did not change significantly over the 6 months and was higher in overweight/obese compared with normal-weight participants. Conclusions Initiation of insulin pump therapy was associated with diminished endorsement of disordered eating behaviors in youth with type 1 diabetes. Longer follow-up studies are needed to assess the impact of insulin pump therapy on glycemic control, weight status, and disordered eating behaviors in this vulnerable population. PMID:23550556

  7. Improving Quality of Care for Maternal and Newborn Health: Prospective Pilot Study of the WHO Safe Childbirth Checklist Program

    PubMed Central

    Kodkany, Bhala; Lipsitz, Stuart; Lashoher, Angela; Dziekan, Gerald; Bahl, Rajiv; Merialdi, Mario; Mathai, Matthews; Lemer, Claire; Gawande, Atul

    2012-01-01

    Background Most maternal deaths, intrapartum-related stillbirths, and newborn deaths in low income countries are preventable but simple, effective methods for improving safety in institutional births have not been devised. Checklist-based interventions aid management of complex or neglected tasks and have been shown to reduce harm in healthcare. We hypothesized that implementation of the WHO Safe Childbirth Checklist program, a novel childbirth safety program for institutional births incorporating a 29-item checklist, would increase delivery of essential childbirth practices linked with improved maternal and perinatal health outcomes. Methods and Findings A pilot, pre-post-intervention study was conducted in a sub-district level birth center in Karnataka, India between July and December 2010. We prospectively observed health workers that attended to women and newborns during 499 consecutively enrolled birth events and compared these with observed practices during 795 consecutively enrolled birth events after the introduction of the WHO Safe Childbirth Checklist program. Twenty-nine essential practices that target the major causes of childbirth-related mortality, such as hand hygiene and uterotonic administration, were evaluated. The primary end point was the average rate of successful delivery of essential childbirth practices by health workers. Delivery of essential childbirth-related care practices at each birth event increased from an average of 10 of 29 practices at baseline (95%CI 9.4, 10.1) to an average of 25 of 29 practices afterwards (95%CI 24.6, 25.3; p<0.001). There was significant improvement in the delivery of 28 out of 29 individual practices. No adverse outcomes relating to the intervention occurred. Study limitations are the pre-post design, potential Hawthorne effect, and focus on processes of care versus health outcomes. Conclusions Introduction of the WHO Safe Childbirth Checklist program markedly improved delivery of essential safety practices

  8. Treating major depression with yoga: A prospective, randomized, controlled pilot trial.

    PubMed

    Prathikanti, Sudha; Rivera, Renee; Cochran, Ashly; Tungol, Jose Gabriel; Fayazmanesh, Nima; Weinmann, Eva

    2017-01-01

    Conventional pharmacotherapies and psychotherapies for major depression are associated with limited adherence to care and relatively low remission rates. Yoga may offer an alternative treatment option, but rigorous studies are few. This randomized controlled trial with blinded outcome assessors examined an 8-week hatha yoga intervention as mono-therapy for mild-to-moderate major depression. Investigators recruited 38 adults in San Francisco meeting criteria for major depression of mild-to-moderate severity, per structured psychiatric interview and scores of 14-28 on Beck Depression Inventory-II (BDI). At screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy, herbal or nutraceutical mood therapies, or mind-body practices were excluded. Participants were 68% female, with mean age 43.4 years (SD = 14.8, range = 22-72), and mean BDI score 22.4 (SD = 4.5). Twenty participants were randomized to 90-minute hatha yoga practice groups twice weekly for 8 weeks. Eighteen participants were randomized to 90-minute attention control education groups twice weekly for 8 weeks. Certified yoga instructors delivered both interventions at a university clinic. Primary outcome was depression severity, measured by BDI scores every 2 weeks from baseline to 8 weeks. Secondary outcomes were self-efficacy and self-esteem, measured by scores on the General Self-Efficacy Scale (GSES) and Rosenberg Self-Esteem Scale (RSES) at baseline and at 8 weeks. In intent-to-treat analysis, yoga participants exhibited significantly greater 8-week decline in BDI scores than controls (p-value = 0.034). In sub-analyses of participants completing final 8-week measures, yoga participants were more likely to achieve remission, defined per final BDI score ≤ 9 (p-value = 0.018). Effect size of yoga in reducing BDI scores was large, per Cohen's d = -0.96 [95%CI, -1.81 to -0.12]. Intervention groups did not differ significantly in 8-week change scores for either the GSES or RSES. In

  9. Treating major depression with yoga: A prospective, randomized, controlled pilot trial

    PubMed Central

    Rivera, Renee; Cochran, Ashly; Tungol, Jose Gabriel; Fayazmanesh, Nima; Weinmann, Eva

    2017-01-01

    Background Conventional pharmacotherapies and psychotherapies for major depression are associated with limited adherence to care and relatively low remission rates. Yoga may offer an alternative treatment option, but rigorous studies are few. This randomized controlled trial with blinded outcome assessors examined an 8-week hatha yoga intervention as mono-therapy for mild-to-moderate major depression. Methods Investigators recruited 38 adults in San Francisco meeting criteria for major depression of mild-to-moderate severity, per structured psychiatric interview and scores of 14–28 on Beck Depression Inventory-II (BDI). At screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy, herbal or nutraceutical mood therapies, or mind-body practices were excluded. Participants were 68% female, with mean age 43.4 years (SD = 14.8, range = 22–72), and mean BDI score 22.4 (SD = 4.5). Twenty participants were randomized to 90-minute hatha yoga practice groups twice weekly for 8 weeks. Eighteen participants were randomized to 90-minute attention control education groups twice weekly for 8 weeks. Certified yoga instructors delivered both interventions at a university clinic. Primary outcome was depression severity, measured by BDI scores every 2 weeks from baseline to 8 weeks. Secondary outcomes were self-efficacy and self-esteem, measured by scores on the General Self-Efficacy Scale (GSES) and Rosenberg Self-Esteem Scale (RSES) at baseline and at 8 weeks. Results In intent-to-treat analysis, yoga participants exhibited significantly greater 8-week decline in BDI scores than controls (p-value = 0.034). In sub-analyses of participants completing final 8-week measures, yoga participants were more likely to achieve remission, defined per final BDI score ≤ 9 (p-value = 0.018). Effect size of yoga in reducing BDI scores was large, per Cohen’s d = -0.96 [95%CI, -1.81 to -0.12]. Intervention groups did not differ significantly in 8-week change scores for

  10. Acceptability of motivational interviewing among hemodialysis clinic staff: a pilot study.

    PubMed

    Cronk, Nikole J; Russell, Cynthia L; Knowles, Norma; Matteson, Michelle; Peace, Leanne; Ponferrada, Leonor

    2012-01-01

    This pilot study investigated the acceptability of motivational interviewing among a group of dialysis clinic staff. A non-experimental, posttest-only design was used for this pilot study. Dialysis clinic staff (N = 8) were recruited from a Midwestern non-profit, freestanding hemodialysis clinic. Staff received three three-hour training sessions in motivational interviewing and monthly individual coaching sessions with a motivational interviewing expert for three months. Staff then completed anonymous questionnaires and participated in a focus group discussion. Staff reported liking the motivational interviewing skills they learned and finding them useful; however, staff reported disagreement with statements indicating they used motivational interviewing skills effectively on a regular basis, that their work environments were supportive of motivational interviewing, and that motivational interviewing was consistent with their natural patient care approach. Results indicate that staff are receptive to motivational interviewing skills, and with sufficient training and feedback to enhance confidence, dialysis staff will develop further motivational interviewing competence and comfort for long-term use.

  11. Clinical variables and implications of the personality on the outcome of bipolar illness: a pilot study

    PubMed Central

    Casas-Barquero, Nieves; García-López, Olga; Fernández-Argüelles, Pedro; Camacho-Laraña, Manuel

    2007-01-01

    Outcome in bipolar patients is affected by comorbidity. Comorbid personality disorders are frequent and may complicate the course of bipolar illness. This pilot study examined a series of 40 euthymic bipolar patients (DSM-IV criteria) (bipolar I disorder 31, bipolar II disorder 9) to assess the effect of clinical variables and the influence of comorbid personality on the clinical course of bipolar illness. Bipolar patients with a diagnosis of comorbid personality disorder (n = 30) were compared with “pure” bipolar patients (n = 10) with regard to demographic, clinical, and course of illness variables. Comorbid personality disorder was diagnosed in 75% of patients according to ICD-10 criteria, with obsessive-compulsive personality disorder being the most frequent type. Sixty-three per cent of subjects had more than one comorbid personality disorder. Bipolar patients with and without comorbid personality disorder showed no significant differences regarding features of the bipolar illness, although the group with comorbid personality disorder showed a younger age at onset, more depressive episodes, and longer duration of bipolar illness. In subjects with comorbid personality disorders, the number of hospitalizations correlated significantly with depressive episodes and there was an inverse correlation between age at the first episode and duration of bipolar illness. These findings, however, should be interpreted taking into account the preliminary nature of a pilot study and the contamination of the sample with too many bipolar II patients. PMID:19300559

  12. Pilot clinical trial of a robot-aided neuro-rehabilitation workstation with stroke patients

    NASA Astrophysics Data System (ADS)

    Krebs, Hermano I.; Hogan, Neville; Aisen, Mindy L.; Volpe, Bruce T.

    1996-12-01

    This paper summarizes our efforts to apply robotics and automation technology to assist, enhance, quantify, and document neuro-rehabilitation. It reviews a pilot clinical trial involving twenty stroke patients with a prototype robot-aided rehabilitation facility developed at MIT and tested at Burke Rehabilitation Hospital. In particular, we present a few results: (a) on the patient's tolerance of the procedure, (b) whether peripheral manipulation of the impaired limb influences brain recovery, (c) on the development of a robot-aided assessment procedure.

  13. Pilot Clinical Studies of Long Duration, Low Intensity Therapeutic Ultrasound for Osteoarthritis.

    PubMed

    Langer, Matthew D; Levine, Vanessa; Taggart, Rebecca; Lewis, George K; Hernandez, Lyndon; Ortiz, Ralph

    2014-04-01

    Osteoarthritis is one of the leading causes of disability in the aging population. Long duration, low intensity therapeutic ultrasound has had promising impact in animal models to slow the progression of the disease and provide joint relief. Two pilot studies were conducted using a novel, wearable platform for delivering ultrasound to evaluate the potential clinical benefits of ultrasound therapy on knee osteoarthritis. There was a pain reduction effect from using ultrasound, as high as fifty two percent in one study. As well, initial data demonstrates that mobility may be increased for patients experiencing mild to moderate arthritis of the knee.

  14. Longitudinal clinical evaluation of fiber-reinforced composite fixed partial dentures: a pilot study.

    PubMed

    Altieri, J V; Burstone, C J; Goldberg, A J; Patel, A P

    1994-01-01

    This report describes a clinical pilot study that monitored a group of 12 patients who have received 14 single tooth replacement experimental restorations made with prefabricated continuous fiber-reinforced composite (FRC) frameworks. Because these restorations represent a purely adhesive restorative system, tooth preparation was not performed. The Kaplan-Meier survival probability at 12 months was approximately 50%. The restoration with the longest service life was a mandibular molar replacement that has remained in service 24 months. With improved survival times, bonded FRC definitive restorations should be plausible.

  15. Anosognosia for hemiplegia: a clinical-anatomical prospective study.

    PubMed

    Vocat, Roland; Staub, Fabienne; Stroppini, Tiziano; Vuilleumier, Patrik

    2010-12-01

    Anosognosia for hemiplegia is a common and striking disorder following stroke. Because it is typically transient and variable, it remains poorly understood and has rarely been investigated at different times in a systematic manner. Our study evaluated a prospective cohort of 58 patients with right-hemisphere stroke and significant motor deficit of the left hemibody, who were examined using a comprehensive neuropsychological battery at 3 days (hyperacute), 1 week (subacute) and 6 months (chronic) after stroke onset. Anosognosia for hemiplegia was frequent in the hyperacute phase (32%), but reduced by almost half 1 week later (18%) and only rarely seen at 6 months (5%). Anosognosia for hemiplegia was correlated with the severity of several other deficits, most notably losses in proprioception, extrapersonal spatial neglect and disorientation. While multiple regression analyses highlighted proprioceptive loss as the most determinant factor for the hyperacute period, and visuospatial neglect and disorientation as more determinant for the subacute phase, patients with both proprioceptive loss and neglect had significantly higher incidence of anosognosia for hemiplegia than those with only one deficit or no deficits (although a few double dissociations were observed). Personal neglect and frontal lobe tests showed no significant relation with anosognosia for hemiplegia, nor did psychological traits such as optimism and mood. Moreover, anosognosia for neglect and prediction of performance in non-motor tasks were unrelated to anosognosia for hemiplegia, suggesting distinct monitoring mechanisms for each of these domains. Finally, by using a voxel-based statistical mapping method to identify lesions associated with a greater severity of anosognosia, we found that damage to the insula (particularly its anterior part) and adjacent subcortical structures was determinant for anosognosia for hemiplegia in the hyperacute period, while additional lesions in the premotor cortex

  16. A Community Health Clinic Breastfeeding-Friendly Pilot: What Can We Learn about the Policy Process?

    PubMed

    Johnson, Donna B; Lamson, Erica; Schwartz, Rachel; Goldhammer, Camie; Ellings, Amy

    2015-11-01

    Implementing evidence-based practices and policies for breastfeeding support in community clinics is a promising, but challenging, approach to reducing disparities in breastfeeding rates. This study aimed to apply a policy process research framework to increase knowledge of factors that facilitate adoption and implementation of breastfeeding policy changes. In 2013, Washington State piloted a process to encourage 8 clinics to adopt and implement steps to become breastfeeding friendly. Evaluation data were collected through interviews, project reports, training evaluations, and pre- and post-self-assessments of achievement of the steps. In 6 months, clinics increased the breastfeeding-friendly steps that they were implementing from a median (interquartile range) of 1.5 (0-3) to 6 (5-7). Improvements were most likely in the steps that required the fewest resources and administrative changes. Barriers to implementation included misperceptions about breastfeeding and breastfeeding support; lack of administrative "buy-in"; need for organizational changes to accommodate actions like monitoring breastfeeding rates and allowing providers training time; and the social-political climate of the clinic. Several factors, including actions taken by public health practitioners, enhanced the change process. These included fostering supportive relationships, targeting technical assistance, and providing resources for planning and training. This pilot project demonstrates that it is possible to make changes in breastfeeding support practices and policies in community clinics. Recommendations to enhance future work include framing and marketing breastfeeding support in ways that resonate with clinic decision makers and enhancing training, resources, and advocacy to build capacity for internal and external systems changes to support breastfeeding best practices. © The Author(s) 2015.

  17. Current Status of Xenotransplantation and Prospects for Clinical Application

    PubMed Central

    Pierson, Richard N.; Dorling, Anthony; Ayares, David; Rees, Michael A.; Seebach, Jörg D.; Fishman, Jay A.; Hering, Bernhard J.; Cooper, David K.C.

    2010-01-01

    Xenotransplantation is one promising approach to bridge the gap between available human cells, tissues, and organs and the needs of patients with diabetes or end-stage organ failure. Based on recent progress using genetically-modified source pigs, improving results with conventional and experimental immunosuppression, and expanded understanding of residual physiologic hurdles, xenotransplantation appears likely to be evaluated in clinical trials in the near future for some select applications. This review offers a comprehensive overview of known mechanisms of xenograft injury, a contemporary assessment of preclinical progress and residual barriers, and our opinions regarding where breakthroughs are likely to occur. PMID:19796067

  18. The human genome project: Prospects and implications for clinical medicine

    SciTech Connect

    Green, E.D.; Waterston, R.H. )

    1991-10-09

    The recently initiated human genome project is a large international effort to elucidate the genetic architecture of the genomes of man and several model organisms. The initial phases of this endeavor involve the establishment of rough blueprints (maps) of the genetic landscape of these genomes, with the long-term goal of determining their precise nucleotide sequences and identifying the genes. The knowledge gained by these studies will provide a vital tool for the study of many biologic processes and will have a profound impact on clinical medicine.

  19. MIH supplementation strategies: prospective clinical and laboratory trial.

    PubMed

    Baroni, C; Marchionni, S

    2011-03-01

    The use of calcium-phosphate casein on hypomineralized molars (molar incisor hypomineralization, MIH) has been proposed but not clinically investigated. Qualitative and quantitative effects of supplementation with a calcium-phosphate casein product on MIH molars were monitored over a period of three years. Molar replicas, minimally invasive biopsies and their SEM microphotographs, plus ESEM/EDX semi-quantitative peaks of elements present in affected enamel were evaluated. Mineralization, morphology, and porosity appeared markedly improved, with calcium and phosphate levels reaching almost normal levels at three years' follow-up. The hypothesis tested was rejected, since calcium-phosphate casein improved enamel morphology in vivo.

  20. The influence of prophylactic vasoactive treatment on cochlear and facial nerve functions after vestibular schwannoma surgery: a prospective and open-label randomized pilot study.

    PubMed

    Scheller, Christian; Richter, Hans-Peter; Engelhardt, Martin; Köenig, Ralph; Antoniadis, Gregor

    2007-07-01

    Facial nerve paresis and hearing loss are common complications after vestibular schwannoma surgery. Experiments with facial nerves of the rat and retrospectively analyzed clinical studies showed a beneficial effect of vasoactive treatment on the preservation of facial and cochlear nerve functions. This prospective and open-label randomized pilot study is the first study of a prophylactic vasoactive treatment in vestibular schwannoma surgery. Thirty patients were randomized before surgery. One group (n = 14) received a vasoactive prophylaxis consisting of nimodipine and hydroxyethylstarch which was started the day before surgery and was continued until the seventh postoperative day. The other group (n = 16) did not receive preoperative medication. Intraoperative monitoring, including acoustic evoked potentials and continuous facial electromyelograms, was applied to all patients. However, when electrophysiological signs of a deterioration of facial or cochlear nerve function were detected in the group of patients without medication, vasoactive treatment was started immediately. Cochlear and facial nerve function were documented preoperatively, during the first 7 days postoperatively, and again after long-term observation. Despite the limited number of patients, our results were significant using the Fisher's exact test (small no. of patients) for a better outcome after vestibular schwannoma surgery for both hearing (P = 0.041) and facial nerve (P = 0.045) preservation in the group of patients who received a prophylactic vasoactive treatment. Prophylactic vasoactive treatment consisting of nimodipine and hydroxyethylstarch shows significantly better results concerning preservation of the facial and cochlear nerve function in vestibular schwannoma surgery. The prophylactic use is also superior to intraoperative vasoactive treatment.

  1. The volume and pH of residual pharyngeal fluid aspirated from the TaperGuard Evac™ Endotracheal Tube following elective surgery: a prospective pilot study.

    PubMed

    Schumann, R; Gandhi, P; Switkowski, K; Grant, M A B; Bonney, I

    2013-03-01

    Oropharyngeal suctioning prior to extubation aims to minimize postextubation tracheal soiling from remaining fluid. We investigated the amount and nature of any fluid remaining after such suctioning and contributing factors. ASA I - III patients undergoing elective surgery under general anesthesia with endotracheal intubation participated in this prospective observational pilot study. Following oropharyngeal suctioning immediately prior to extubation, a dedicated port of the endotracheal tube (TaperGuard Evac™ Endotracheal Tube) was aspirated. The amount and pH of residual fluid was recorded. Data collection included age, sex, body mass index, comorbidities, ASA status, procedure type and duration. The Chi-Square, Wilcoxon Rank-Sum, t-tests, and univariate regression analysis were used as appropriate. Ninety-eight patients completed the study. The mean aspirated volume in 38 (38.8%) patients was 0.9 ± 1.3 mL and sixty patients (61.2%) had no aspirate. A body mass index of ≥ 30 kg/m2 was associated with the presence of fluid (P=0.03), and a higher volume (P=0.03). The fluid pH was 7 ± 0.81 (mean ± SD). A duration of surgery ≥ 120 minutes predicted a lower pH. The prevalence and amount of residual fluid after oropharyngeal suctioning was low and likely clinically insignificant. A higher body mass index was associated with a higher incidence and volume of residual fluid. Longer procedure duration determined a slightly lower pH, with a mildly acidic pH range. The possibility of a lower fluid pH after prolonged surgery contributing to postoperative sore throat via mucosal irritation warrants investigation.

  2. Progress and prospects: hurdles to cardiovascular gene therapy clinical trials.

    PubMed

    Hedman, M; Hartikainen, J; Ylä-Herttuala, S

    2011-08-01

    Several gene therapy approaches have been designed for the treatment of cardiovascular diseases. A positive finding is that the safety of cardiovascular gene therapy has been excellent even in long-term follow-up. However, several hurdles to this field are still present. A major disappointing feature of the trials is that while preclinical and uncontrolled phase-I gene therapy trials have been positive, none of the randomized controlled phase-II/III cardiovascular gene therapy trials have shown clinically relevant positive effects. Low gene transfer efficiency seems to be associated with several trials. A sophisticated efficient delivery method for cardiovascular applications is still lacking and only low concentrations of the gene product are produced in the target tissues. Only a few gene therapy vectors can be produced in large scale. In addition, inflammatory reactions against vectors and inability to regulate gene expression are still present. Furthermore, a strong placebo effect is affecting the results in gene therapy trials, and long-term trials have become more difficult to conduct because of the multiplicity of therapies applied simultaneously on the patients. This review summarizes advances and obstacles of current cardiovascular clinical gene therapy trials.

  3. UVA1 phototherapy in the treatment of palmoplantar pustulosis: a pilot prospective study.

    PubMed

    Su, Li-Na; Xu, Xin; Tang, Li; Yu, Ning; Ding, Yang-Feng

    2016-11-01

    Palmoplantar pustulosis (PPP) is recalcitrant to traditional topical and systemic therapies. Ultraviolet A1 (UVA1) phototherapy, a new therapeutic approach, has recently been shown good efficacy in the treatment of PPP. The purpose of this study was to evaluate the efficacy and safety of UVA1 therapy for the treatment of PPP. Patients with PPP were treated with UVA1 irradiation three times a week for up to 30 sessions and had a 3-month follow-up visit. UVA1 therapy was conducted with a fixed dose (80 J/cm(2)). Clinical evaluation was based on the Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI) score. Totally, 62 patients completed the study. The mean PPPASI score decreased from a baseline value of 9.4 ± 2.8 to a value of 4.9 ± 2.4 at 15 sessions, 1.7 ± 1.9 at 30 sessions, and 2.0 ± 2.1 at follow-up visit. A reduction of 75 % in the PPPASI score was observed in 4 (6.5 %) patients at 15 sessions and 45 (72.6 %) patients at 30 sessions. The adverse effects were limited including burning sensation, pruritus, and hyperpigmentation. UVA1 is an effective therapy for PPP with mild side effects.

  4. Neural response imaging (NRI) cochlear mapping: prospects for clinical application.

    PubMed

    Arnold, L; Lindsey, P; Hacking, C; Boyle, P

    2007-12-01

    The objective of the study was to investigate the potential for clinical application of neural response imaging (NRI) cochlear mapping. Cochlear mapping was performed at each fitting session up to at least six months following initial fitting. Stimulation was delivered to one electrode site. NRI was recorded from each of the remaining sites. The procedure was repeated for apical, medial and basal stimulation sites, stimulating at subjective threshold and most comfortable levels. Responses were obtained in five out of six subjects and are discussed in terms of: reproducibility, quality, changes over time. Cochlear mapping provided repeatable data that gave interesting insights into the implanted cochlea. Further work is required to determine whether this approach could contribute to programme optimisation.

  5. Neglected ends: clinical ethics consultation and the prospects for closure.

    PubMed

    Fiester, Autumn

    2015-01-01

    Clinical ethics consultations (CECs) are sometimes deemed complete at the moment when the consultants make a recommendation. In CECs that involve actual ethical conflict, this view of a consult's endpoint runs the risk of overemphasizing the conflict's resolution at the expense of the consult's process, which can have deleterious effects on the various parties in the conflict. This overly narrow focus on reaching a decision or recommendation in consults that involve profound moral disagreement can result in two types of adverse, lingering sequelae: moral distress or negative moral emotions. The problem, succinctly named, is that such consults have insufficient "closure" for patients, families, and providers. To promote closure, and avoid the ills of moral distress and the moral emotions, I argue that CECs need to prioritize assisted conversation between the different stakeholders in these conflicts, what is often referred to as "bioethics mediation."

  6. Clinical features of celiac disease: a prospective birth cohort.

    PubMed

    Agardh, Daniel; Lee, Hye-Seung; Kurppa, Kalle; Simell, Ville; Aronsson, Carin Andrén; Jörneus, Ola; Hummel, Michael; Liu, Edwin; Koletzko, Sibylle

    2015-04-01

    To investigate clinical features of celiac disease (CD) and their association with risk factors for CD in a genetic risk birth cohort. Children from 6 clinical centers in 4 countries positive for HLA-DR3-DQ2 or DR4-DQ8 were annually screened for tissue transglutaminase antibodies (tTGA) and assessed for symptoms by questionnaires. Associations of symptoms with anthropometrics, known risk factors for CD, tTGA levels, and mucosal lesions in those biopsied were examined. Of 6706 screened children, 914 developed persistent positive tTGA, 406 underwent biopsies, and 340 had CD. Compared with age-matched tTGA-negative children, those with persistent tTGA were more likely to have symptoms at 2 (34% vs 19%, P < .001) and 3 years of age (28% vs 19%, P = .009) but not at 4 years (27% vs 21%, NS). Z-scores for height, weight, and BMI did not differ between groups. In children with persistent tTGA, having ≥ 1 symptom was associated with family history of CD (odds ratio = 2.59, 95% confidence interval, 1.21-5.57) but not with age, gender, or HLA-DR3-DQ2 homozygosity. At seroconversion, tTGA levels were higher in symptomatic than asymptomatic children (P < .001), in those from CD families (P < .001), and in US participants (P < .001) but not associated with age, gender, or HLA genotype. tTGA levels correlated with severity of mucosal lesions both in symptomatic (r = 0.53, P < .001) and asymptomatic children (r = 0.22, P = .01). A majority of children detected with persistent tTGA in screenings are asymptomatic and have normal growth by age 4 years. tTGA levels correlate more strongly with severity of mucosal lesions in symptomatic as compared with asymptomatic children. Copyright © 2015 by the American Academy of Pediatrics.

  7. Training oncology and palliative care clinical nurse specialists in psychological skills: evaluation of a pilot study.

    PubMed

    Clark, Jane E; Aitken, Susan; Watson, Nina; McVey, Joanne; Helbert, Jan; Wraith, Anita; Taylor, Vanessa; Catesby, Sarah

    2015-06-01

    National guidelines in the United Kingdom recommend training Clinical Nurse Specialists in psychological skills to improve the assessment and intervention with psychological problems experienced by people with a cancer diagnosis (National Institute for Health and Clinical Excellence, 2004). This pilot study evaluated a three-day training program combined with supervision sessions from Clinical Psychologists that focused on developing skills in psychological assessment and intervention for common problems experienced by people with cancer. Questionnaires were developed to measure participants' levels of confidence in 15 competencies of psychological skills. Participants completed these prior to the program and on completion of the program. Summative evaluation was undertaken and results were compared. In addition, a focus group interview provided qualitative data of participants' experiences of the structure, process, and outcomes of the program. Following the program, participants rated their confidence in psychological assessment and skills associated with providing psychological support as having increased in all areas. This included improved knowledge of psychological theories, skills in assessment and intervention and accessing and using supervision appropriately. The largest increase was in providing psycho-education to support the coping strategies of patients and carers. Thematic analysis of interview data identified two main themes including learning experiences and program enhancements. The significance of the clinical supervision sessions as key learning opportunities, achieved through the development of a community of practice, emerged. Although this pilot study has limitations, the results suggest that a combined teaching and supervision program is effective in improving Clinical Nurse Specialists' confidence level in specific psychological skills. Participants' experiences highlighted suggestions for refinement and development of the program

  8. Integrating a prospective pilot trial and patient-derived xenografts to trace metabolic changes associated with acute myeloid leukemia.

    PubMed

    Carrabba, Matteo G; Tavel, Laurette; Oliveira, Giacomo; Forcina, Alessandra; Quilici, Giacomo; Nardelli, Francesca; Tresoldi, Cristina; Ambrosi, Alessandro; Ciceri, Fabio; Bernardi, Massimo; Vago, Luca; Musco, Giovanna

    2016-10-28

    Despite the considerable progress in understanding the molecular bases of acute myeloid leukemia (AML), new tools to link disease biology to the unpredictable patient clinical course are still needed. Herein, high-throughput metabolomics, combined with the other "-omics" disciplines, holds promise in identifying disease-specific and clinically relevant features.In this study, we took advantage of nuclear magnetic resonance (NMR) to trace AML-associated metabolic trajectory employing two complementary strategies. On the one hand, we performed a prospective observational clinical trial to identify metabolic changes associated with blast clearance during the first two cycles of intensive chemotherapy in nine adult patients. On the other hand, to reduce the intrinsic variability associated with human samples and AML genetic heterogeneity, we analyzed the metabolic changes in the plasma of immunocompromised mice upon engraftment of primary human AML blasts.Combining the two longitudinal approaches, we narrowed our screen to seven common metabolites, for which we observed a mirror-like trajectory in mice and humans, tracing AML progression and remission, respectively. We interpreted this set of metabolites as a dynamic fingerprint of AML evolution.Overall, these NMR-based metabolomic data, to be consolidated in larger cohorts and integrated in more comprehensive system biology approaches, hold promise for providing valuable and non-redundant information on the systemic effects of leukemia.

  9. Variations of Gonadal Veins: Embryological Prospective and Clinical Significance

    PubMed Central

    Gupta, Raman; Aggarwal, Navita

    2015-01-01

    Introduction: An adequate knowledge of anomalies of gonadal veins will help the radiologists and surgeons in recognition and protection of these veins which play major roles in thermo-regulation that is essential for the efficient functioning of testis on which the survival of the human species depends. Aim: The aim of this work is to present an analysis of the anatomical variations of gonadal veins. An effort has also been made to explicate the possible embryological model of development of such variants and to present the variable clinical aspects concerning them. Materials and Methods: Gonadal veins in 60 dissection room cadavers were examined for variations from the classic anatomic description. Result: In the present study, out of 60 cases, male: female ratio was 2:1(40:20) in which no variation was found in ovarian veins. In the 18 (45%) cases, testicular veins showed variations which consist of duplication and atypical drainage. Discussion: Variations of drainage of gonadal vein are due to error of embryological development in venous shift and alteration in anastomotic channel of post-cardinal, supra-cardinal and sub cardinal veins. Conclusion: The gonadal veins present numeric variations as well as variations in its site of drainage, which attributed to the various pathological conditions as varicocele and pelvic congestion syndrome, leading to infertility in patients. Hence, in -depth knowledge of these developmental anomalies of gonadal veins is important. PMID:25859438

  10. Can virtual reality be used to conduct mass prophylaxis clinic training? A pilot program.

    PubMed

    Yellowlees, Peter; Cook, James N; Marks, Shayna L; Wolfe, Daniel; Mangin, Elanor

    2008-03-01

    To create and evaluate a pilot bioterrorism defense training environment using virtual reality technology. The present pilot project used Second Life, an internet-based virtual world system, to construct a virtual reality environment to mimic an actual setting that might be used as a Strategic National Stockpile (SNS) distribution site for northern California in the event of a bioterrorist attack. Scripted characters were integrated into the system as mock patients to analyze various clinic workflow scenarios. Users tested the virtual environment over two sessions. Thirteen users who toured the environment were asked to complete an evaluation survey. Respondents reported that the virtual reality system was relevant to their practice and had potential as a method of bioterrorism defense training. Computer simulations of bioterrorism defense training scenarios are feasible with existing personal computer technology. The use of internet-connected virtual environments holds promise for bioterrorism defense training. Recommendations are made for public health agencies regarding the implementation and benefits of using virtual reality for mass prophylaxis clinic training.

  11. First clinical pilot study with intravascular polarization sensitive optical coherence tomography (Conference Presentation)

    NASA Astrophysics Data System (ADS)

    Villiger, Martin; Karanasos, Antonios; Ren, Jian; Lippok, Norman; Shishkov, Milen; Daemen, Joost; Van Mieghem, Nicolas; Diletti, Roberto; Valgimigli, Marco; van Geuns, Robert-Jan; de Jaegere, Peter; Zijlstra, Felix; van Soest, Gijs; Nadkarni, Seemantini; Regar, Evelyn; Bouma, Brett E.

    2016-02-01

    Polarization sensitive (PS) OCT measures the polarization states of the light backscattered by tissue and provides measures of tissue birefringence and depolarization in addition to the structural OCT signal. Ex vivo studies have demonstrated that birefringence is increased in tissue rich in collagen and with elevated smooth muscle cell content. Preliminary data further suggests that depolarization can identify regions of macrophage infiltration, lipid, and irregularly arranged collagen fibers. These are important aspects of the mechanical integrity and vulnerability of atherosclerotic plaques. To evaluate the potential of PS-OCT in the clinical setting, we combined our custom PS-OCT system with commercially available OCT catheters (Fastview, Terumo Corporation) and performed a pilot study in 30 patients, scheduled to undergo percutaneous coronary intervention (PCI) on the grounds of stable or unstable angina. A total of 82 pullbacks in 39 vessels were performed, either in the native coronary arteries or post procedure. Comparing consecutive pullbacks of the same coronary artery, we found excellent agreement between the polarization features in the repeat pullbacks, validating the repeatability and robustness of PS-OCT in the clinical in vivo setting. In addition we observed that the birefringence and depolarization features vary significantly across lesions with identical structural OCT appearance, suggesting morphological subtypes. This first human pilot study proved the feasibility and robustness of intravascular PS-OCT. PS-OCT achieves improved tissue characterization and may help in identifying high-risk plaques, with the potential to ultimately improve risk stratification and help guiding PCI.

  12. Premature Discontinuation of Prospective Clinical Studies Approved by a Research Ethics Committee – A Comparison of Randomised and Non-Randomised Studies

    PubMed Central

    Oeller, Patrick; Kasenda, Benjamin; Briel, Matthias; von Elm, Erik

    2016-01-01

    Background Premature discontinuation of clinical studies affects about 25% of randomised controlled trials (RCTs) which raises concerns about waste of scarce resources for research. The risk of discontinuation of non-randomised prospective studies (NPSs) is yet unclear. Objectives To compare the proportion of discontinued studies between NPSs and RCTs that received ethical approval. Methods We systematically surveyed prospective longitudinal clinical studies that were approved by a single REC in Freiburg, Germany between 2000 and 2002. We collected study characteristics, identified subsequent publications, and surveyed investigators to elucidate whether a study was discontinued and, if so, why. Results Of 917 approved studies, 547 were prospective longitudinal studies (306 RCTs and 241 NPSs). NPSs were on average smaller than RCTs, more frequently single centre and pilot studies, and less frequently funded by industry. NPSs were less frequently discontinued than RCTs: 32/221 (14%) versus 78/288 (27%, p<0.001, missing data excluded). Poor recruitment was the most frequent reason for discontinuation in both NPSs (36%) and RCTs (37%). Conclusions Compared to RCTs, NPSs were at lower risk for discontinuation. Measures to reliably predict, sustain, and stimulate recruitment could prevent discontinuation of many RCTs but also of some NPSs. PMID:27792749

  13. Clinical risk factors for bipolar disorders: a systematic review of prospective studies.

    PubMed

    Faedda, Gianni L; Serra, Giulia; Marangoni, Ciro; Salvatore, Paola; Sani, Gabriele; Vázquez, Gustavo H; Tondo, Leonardo; Girardi, Paolo; Baldessarini, Ross J; Koukopoulos, Athanasios

    2014-10-01

    Early phases and suspected precursor states of bipolar disorder are not well characterized. We evaluate the prevalence, duration, clinical features and predictive value of non-affective psychopathology as clinical risk factors for bipolar disorder in prospective studies. We screened PubMed, CINAHL, PsycINFO, Embase, SCOPUS, and ISI-Web of Science databases from inception up to January 31, 2014, following PRISMA guidelines (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and searched: bipolar disorder AND [antecedent⁎ OR predict⁎ OR prodrom⁎ OR prospect⁎ OR risk⁎] AND [diagnosis OR development]. We included only English language reports on prospective, longitudinal studies with two structured clinical assessments (intake and follow-up); no DSM intake diagnosis of bipolar-I or -II; diagnostic outcome was bipolar-I or -II. Details of study design, risk factors, and predictive value were tabulated. We found 16 published reports meeting selection criteria, with varying study design. Despite heterogeneity in methods, findings across studies were consistent. Clinical risk factors of bipolar disorder were early-onset panic attacks and disorder, separation anxiety and generalized anxiety disorders, conduct symptoms and disorder, ADHD, impulsivity and criminal behavior. Since risk factors identified in some prospective studies are predictive of other conditions besides bipolar disorder, these preliminary findings require replication, and their sensitivity, specificity and predictive value need to be assessed. Clinical risk factors for bipolar disorder typically arise years prior to syndromal onset, include anxiety and behavioral disorders with unclear sensitivity and specificity. Prospectively identified clinical risk factors for bipolar disorder are consistent with retrospective and family-risk studies. Combining clinical risk factors with precursors and family-risk may improve early identification and timely and appropriate treatment of

  14. Paroxysmal hemicrania: a prospective clinical study of 31 cases.

    PubMed

    Cittadini, Elisabetta; Matharu, Manjit S; Goadsby, Peter J

    2008-04-01

    Paroxysmal hemicrania is a rare syndrome characterized by repeated attacks of strictly unilateral, severe, short-lasting pain occurring with cranial autonomic features. The hallmarks of this syndrome are the relatively short attacks and the exquisite response to indometacin. We describe the phenotype of this condition in a series of 31 patients. The mean duration of attack was 17 min. The mean attack frequency was 11. The distribution of the pain was orbital and temporal in 77% of the patients, retro-orbital in 61%, frontal in 55%, occipital in 42%; although pain was also reported in the vertex, second division of trigeminal nerve, neck, nose, jaw, parietal region, ear, teeth, eyebrow, shoulder (ipsilateral and bilateral), arm and third division of trigeminal nerve. Of the cohort, 87% had lacrimation, 68% had conjunctival injection, 58% rhinorrhoea, 54% nasal congestion, ptosis and facial flushing. Other cranial autonomic features include eyelid oedema, forehead/facial sweating, sense of aural fullness and periaural swelling, miosis, mydriasis and swelling of the cheek. The majority of the patients (80%) were agitated or restless, or both, with the pain and 26% were aggressive. All patients had positive placebo control indometacin test (100-200 mg intramuscularly), or a positive oral indometacin trial or both. We suggest the International Headache Society criteria be revised to remove specification of attack site, and to include the full range of cranial autonomic features. Currently, the sine qua non for paroxysmal hemicrania is a response to indometacin. Since there is no reliable clinical marker of that response we recommend an indometacin test, either orally or by injection for any patient with lateralized discrete attacks of head pain with associated cranial autonomic symptoms.

  15. The use of clinical logs to improve nursing students' metacognition: a pilot study.

    PubMed

    Fonteyn, M E; Cahill, M

    1998-07-01

    The purpose of this study was to examine the effectiveness of the use of a reflective clinical log to improve students' thinking strategies and metacognition (cognitive awareness). Rather than prepare a written nursing care plan prior to entering the clinical setting, students instead were asked to write in a clinical log at the completion of their clinical day, reflecting upon client problems that they had identified, the data that were used to identify these problems, the nursing interventions that were used, and the results of these interventions. The students reported that they preferred the use of a reflective log over writing nursing care plans and they felt that the logs improved their ability to think about their thinking (i.e. their metacognition). The results of this pilot study indicate that reflection in clinical logs assists students to become more active learners, to manage their own thinking, and to improve their metacognition. Additional research in this area is needed to confirm study findings and to provide further understanding regarding the effectiveness of clinical logs as a teaching strategy to improve students' metacognition.

  16. Treatment via videoconferencing: a pilot study of delivery by clinical psychology trainees.

    PubMed

    Dunstan, Debra A; Tooth, Susan M

    2012-04-01

    This pilot study explored the outcomes of clinical psychology trainees delivering treatments via videoconferencing. A noncurrent, multiple baseline across subjects and settings. University outpatient psychology clinic. Six clients (two men and four women) with an anxiety or depressive disorder were randomly assigned to received six sessions of individual therapy (either via videoconferencing or face to face) from a male or female clinical psychology trainee. Participants provided daily ratings (0-10) of subjective distress/well-being via text messaging, and at pre-, post-, and 1 month follow-up of treatment, completed the Depression Anxiety Stress Scales and the Outcome Questionnaire-45. Along with the trainees, participants also provided feedback on the therapy experience. The subjective well-being of all participants improved, and all videoconferencing participants showed a statistically and clinically significant reduction in symptomology and gains in general life functioning. Feedback comments were positive. This study suggests that there is value in clinical psychology trainees gaining experience in the delivery of treatments via videoconferencing. Further study is needed to demonstrate the potential for university clinics to deliver mental health services, via this modality, to rural and remote areas. © 2012 The Authors. Australian Journal of Rural Health © 2012 National Rural Health Alliance Inc.

  17. A prospective trial evaluating the clinical performance of a novel surgical energy device in laparoscopic colon surgery.

    PubMed

    Milsom, J W; Trencheva, K; Sonoda, T; Nandakumar, G; Shukla, P J; Lee, S

    2015-05-01

    The aim of this prospective human trial was to evaluate the clinical performance of a novel THUNDERBEAT (TB) energy device in laparoscopic colon surgery. This study reports the first human trial in USA with this combined energy device in colon surgery. This is a prospective pilot study with 30 subjects undergoing left or right laparoscopic colon resection for neoplasm in a single institution. All soft tissue dissections and all vessel ligations were performed using TB. No other energy device was used within the abdomen. Recorded end-points were dissection time (from the start of colon mobilization to specimen removal), surgical procedure time, the number of times TB taken out of the abdominal cavity, intraoperative complications (bleeding at the time of mesenteric dissection or vessel ligation, thermal injury during surgery, injury of other organs), technical device problems, postoperative complications (bleeding, delayed thermal injuries, other complications within 30 days), length of hospital stay, and mortality. Thirty subjects (15 males) were enrolled in the study with median age and range 68.5 (21-86) and BMI kg/m(2) 25.5 (20-35). Twelve subjects underwent right and 18 left laparoscopic hemicolectomy. The mean surgical procedure time was 163 ± 86 min and for dissection using TB device 80.6 ± 35 min. Major vessel ligation was successful in all subjects. The median number of TB applications to seal inferior mesenteric artery was 3 (2-8). TB was taken out of the abdominal cavity during dissection for tip cleaning a medium number of two times/per case. No intraoperative or postoperative complications (bleeding, thermal injuries, etc.) related to use of TB were noted. The TB device demonstrated efficient and successful performance at tissue dissection and vessel ligation in left and right colectomies. TB technology can be employed in complex abdominal surgery and may save time through faster dissection but comparative studies with other energy devices are needed

  18. Prospective, Naturalistic, Pilot Study of Open-Label Atomoxetine Treatment in Preschool Children with Attention-Deficit/Hyperactivity Disorder

    PubMed Central

    Aman, Michael G.; Ghuman, Harinder S.; Reichenbacher, Thomas; Gelenberg, Alan; Wright, Ron; Rice, Sydney; Fort, Carolyn

    2009-01-01

    Abstract Objective The aim of this study was to report preliminary data regarding effectiveness and tolerability of atomoxetine in 3- to 5-year-old preschool children with attention-deficit/hyperactivity disorder (ADHD). Methods Nine boys and 3 girls (mean age = 5.0 ± 0.72 years) diagnosed with ADHD were treated with atomoxetine in an open-label pilot study. Atomoxetine was gradually titrated to a maximum dose of 1.8 mg/kg per day. Results There was a significant effect of time from baseline to end point on the parent-rated hyperactivity/impulsivity Swanson Nolan and Pelham (SNAP-IV-HI) subscale ratings (F[9, 11] = 6.32, p < 0.0001). The mean difference between the baseline and end-point parent SNAP-IV-HI scores was 10.2 ± 7.3 (p = 0.0005). The rate of positive response (defined as at least a 30% reduction in the end-point parent SNAP-IV-HI scores and a Clinical Global Impressions–Improvement [CGI-I] rating of Much Improved or Very Much Improved) was 75%. The Children's Global Assessment Scale scores improved significantly over time [F(9, 11) = 6.24 p < 0.001]. The mean end-point daily dose of atomoxetine was 1.59 ± 0.3 mg/kg. A high proportion (66.7%) of the preschoolers experienced side effects with atomoxetine. Side effects of defiance, tantrums, aggression, and irritability were most disconcerting to parents, and gastrointestinal complaints were the most commonly reported adverse effects. One child was terminated from the study due to “chest ache.” There were no changes in weight, height, or cardiovascular measures. Conclusion This open-label pilot study provides preliminary evidence of effectiveness and tolerability of atomoxetine for treating ADHD in preschool children, although double-blind, randomized, placebo-controlled studies are needed to confirm this. PMID:19364293

  19. Malabsorption and nutritional balance in the ICU: fecal weight as a biomarker: a prospective observational pilot study

    PubMed Central

    2011-01-01

    Introduction Malabsorption, which is frequently underdiagnosed in critically ill patients, is clinically relevant with regard to nutritional balance and nutritional management. We aimed to validate the diagnostic accuracy of fecal weight as a biomarker for fecal loss and additionally to assess fecal macronutrient contents and intestinal absorption capacity in ICU patients. Methods This was an observational pilot study in a tertiary mixed medical-surgical ICU in hemodynamically stable adult ICU patients, without clinically evident gastrointestinal malfunction. Fecal weight (grams/day), fecal energy (by bomb calorimetry in kcal/day), and macronutrient content (fat, protein, and carbohydrate in grams/day) were measured. Diagnostic accuracy expressed in terms of test sensitivity, specificity, positive (PPV) and negative predictive value (NPV), and receiver operator curves (ROCs) were calculated for fecal weight as a marker for energy malabsorption. Malabsorption was a priori defined as < 85% intestinal absorption capacity. Results Forty-eight patients (63 ± 15 years; 58% men) receiving full enteral feeding were included. A cut-off fecal production of > 350 g/day (that is, diarrhea) was linked to the optimal ROC (0.879), showing a sensitivity and PPV of 80%, respectively. Specificity and NPV were both 96%. Fecal weight (grams/day) and intestinal energy-absorption capacity were inversely correlated (r = -0.69; P < 0.001). Patients with > 350 g feces/day had a significantly more-negative energy balance compared with patients with < 350 g feces/day (loss of 627 kcal/day versus neutral balance; P = 0.012). Conclusions A fecal weight > 350 g/day in ICU patients is a biomarker applicable in daily practice, which can act as a surrogate for fecal energy loss and intestinal energy absorption. Daily measurement of fecal weight is a feasible means of monitoring the nutritional status of critically ill patients and, in those identified as having malabsorption, can monitor

  20. Early impairment of intracranial conduction time predicts mortality in deeply sedated critically ill patients: a prospective observational pilot study.

    PubMed

    Azabou, Eric; Rohaut, Benjamin; Heming, Nicholas; Magalhaes, Eric; Morizot-Koutlidis, Régine; Kandelman, Stanislas; Allary, Jeremy; Moneger, Guy; Polito, Andrea; Maxime, Virginie; Annane, Djillali; Lofaso, Frederic; Chrétien, Fabrice; Mantz, Jean; Porcher, Raphael; Sharshar, Tarek

    2017-12-01

    Somatosensory (SSEP) and brainstem auditory (BAEP) evoked potentials are neurophysiological tools which, respectively, explore the intracranial conduction time (ICCT) and the intrapontine conduction time (IPCT). The prognostic values of prolonged cerebral conduction times in deeply sedated patients have never been assessed. Sedated patients are at risk of developing new neurological complications, undetected. In this prospective observational bi-center pilot study, we investigated whether early impairment of SSEP's ICCT and/or BAEP's IPCT could predict in-ICU mortality or altered mental status (AMS), in deeply sedated critically ill patients. SSEP by stimulation of the median nerve and BAEP were assessed in critically ill patients receiving deep sedation on day 3 following ICU admission. Deep sedation was defined by a Richmond Assessment sedation Scale (RASS) <-3. Mean left- and right-side ICCT and IPCT were measured for each patient. Primary and secondary outcomes were, respectively, in-ICU mortality and AMS defined as the occurrence of delirium and/or delayed awakening after discontinuation of sedation. Eighty-six patients were studied of which 49 (57%) were non-brain-injured and 37 (43%) were brain-injured. Impaired ICCT was a predictor of in-ICU mortality after adjustment on the global Sequential Organ Failure Assessment score (SOFA) [OR (95% CI) = 2.69 (1.05-6.85); p = 0.039] and on the non-neurological SOFA components [2.67 (1.05-6.81); p = 0.040]. IPCT was more frequently delayed in the subgroup of patients who developed post-sedation AMS (24%) compared those without AMS (0%). However, this difference did not reach statistical significance (p = 0.053). Impairment rates of ICCT and IPCT were not found to be significantly different between non-brain- and brain-injured subgroups of patients. In critically ill patients receiving deep sedation, early ICCT impairment was associated with mortality. Somatosensory and brainstem auditory evoked potentials may

  1. Interpreter training for medical students: pilot implementation and assessment in a student-run clinic.

    PubMed

    Diaz, Jennifer E L; Ekasumara, Nydia; Menon, Nikhil R; Homan, Edwin; Rajarajan, Prashanth; Zamudio, Andrés Ramírez; Kim, Annie J; Gruener, Jason; Poliandro, Edward; Thomas, David C; Meah, Yasmin S; Soriano, Rainier P

    2016-09-29

    Trained medical interpreters are instrumental to patient satisfaction and quality of care. They are especially important in student-run clinics, where many patients have limited English proficiency. Because student-run clinics have ties to their medical schools, they have access to bilingual students who may volunteer to interpret, but are not necessarily formally trained. To study the feasibility and efficacy of leveraging medical student volunteers to improve interpretation services, we performed a pilot study at the student-run clinic at the Icahn School of Medicine at Mount Sinai. In each fall semester in 2012-2015, we implemented a 6-h course providing didactic and interactive training on medical Spanish interpreting techniques and language skills to bilingual students. We then assessed the impact of the course on interpreter abilities. Participants' comfort levels, understanding of their roles, and understanding of terminology significantly increased after the course (p < 0.05), and these gains remained several months later (p < 0.05) and were repeated in an independent cohort. Patients and student clinicians also rated participants highly (averages above 4.5 out of 5) on these measures in real clinical encounters. These findings suggest that a formal interpreter training course tailored for medical students in the setting of a student-run clinic is feasible and effective. This program for training qualified student interpreters can serve as a model for other settings where medical students serve as interpreters.

  2. A single center, pilot, double-blinded, randomized, comparative, prospective clinical study to evaluate improvements in the structure and function of facial skin with tazarotene 0.1% cream alone and in combination with GliSODin(®) Skin Nutrients Advanced Anti-Aging Formula.

    PubMed

    Goldberg, Lawrence D; Crysler, Corina

    2014-01-01

    Superoxide dismutase (SOD) reduces the reactive oxygen species formation associated with oxidative stress. An imbalance between free radicals and antioxidants can lead to accelerated aging. GliSODin(®) Skin Nutrients Advanced Anti-Aging Formula (GAAF) is an SOD-containing dietary nutricosmetic formulated with other nutraceuticals that promote improvements in the structure and function of the skin, including hydration, elasticity, structural integrity, and photoaging caused by oxidative stress. Tazarotene cream 0.1% (TAZ) is a United States Food and Drug Administration-approved drug indicated for use in the mitigation of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines when taken in conjunction with a comprehensive skin care and sun avoidance program. To determine if the antioxidant, anti-aging, hydrating and skin-rejuvenating properties of GAAF complement the retinoic actions of TAZ to improve the structure and function of facial skin. A 90-day comparative study of ten subjects with facial photodamage; daily topical application of TAZ was used in combination with three capsules of GAAF (780 mg each) or placebo orally, with food, per the randomization allocation. After 90 days of treatment, TAZ alone and in combination with GAAF improved fine wrinkles (↓1.2 versus 2.0), mottled hyperpigmentation (↓2.2 versus 2.8) and overall photodamage (↓1.0 versus 1.8), as well as patient-reported response to treatment (↓2.0 versus 1.6). At week 12, TAZ/GAAF combination treatment (Group A) versus TAZ treatment alone (Group C) was of significant clinical benefit, with respect to fine wrinkling (14.7%/41.7%), overall photodamage (15.6%/53.0%), skin moisture (19.1%/103.2%), skin elasticity (12.8%/87.7%), and response to treatment (8.8%/21.4%). The study suggests GAAF in combination with TAZ is safe and provides significant clinical benefit with relative improvement in facial fine wrinkling, overall photodamage, skin moisture and

  3. A single center, pilot, double-blinded, randomized, comparative, prospective clinical study to evaluate improvements in the structure and function of facial skin with tazarotene 0.1% cream alone and in combination with GliSODin® Skin Nutrients Advanced Anti-Aging Formula

    PubMed Central

    Goldberg, Lawrence D; Crysler, Corina

    2014-01-01

    Background Superoxide dismutase (SOD) reduces the reactive oxygen species formation associated with oxidative stress. An imbalance between free radicals and antioxidants can lead to accelerated aging. GliSODin® Skin Nutrients Advanced Anti-Aging Formula (GAAF) is an SOD-containing dietary nutricosmetic formulated with other nutraceuticals that promote improvements in the structure and function of the skin, including hydration, elasticity, structural integrity, and photoaging caused by oxidative stress. Tazarotene cream 0.1% (TAZ) is a United States Food and Drug Administration-approved drug indicated for use in the mitigation of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines when taken in conjunction with a comprehensive skin care and sun avoidance program. Objective To determine if the antioxidant, anti-aging, hydrating and skin-rejuvenating properties of GAAF complement the retinoic actions of TAZ to improve the structure and function of facial skin. Method A 90-day comparative study of ten subjects with facial photodamage; daily topical application of TAZ was used in combination with three capsules of GAAF (780 mg each) or placebo orally, with food, per the randomization allocation. Results After 90 days of treatment, TAZ alone and in combination with GAAF improved fine wrinkles (↓1.2 versus 2.0), mottled hyperpigmentation (↓2.2 versus 2.8) and overall photodamage (↓1.0 versus 1.8), as well as patient-reported response to treatment (↓2.0 versus 1.6). At week 12, TAZ/GAAF combination treatment (Group A) versus TAZ treatment alone (Group C) was of significant clinical benefit, with respect to fine wrinkling (14.7%/41.7%), overall photodamage (15.6%/53.0%), skin moisture (19.1%/103.2%), skin elasticity (12.8%/87.7%), and response to treatment (8.8%/21.4%). Conclusion The study suggests GAAF in combination with TAZ is safe and provides significant clinical benefit with relative improvement in facial fine

  4. Coronally advanced flap with two different techniques for the treatment of multiple gingival recessions: A pilot prospective comparative case series.

    PubMed

    Barrella, Guilherme Emerson; Kolbe, Maria Fernanda; Ribeiro, Fernanda Vieira; Casati, Marcio Zaffalon; Casarin, Renato Correa; Cirano, Fabiano Ribeiro; Pimentel, Suzana Peres

    2016-01-01

    The objective of this prospective study was to compare the clinical outcomes of coronally advanced flap (CAF) using two different surgical strategies in the treatment of multiple gingival recessions. Ten patients presenting with a total of 81 Miller class I gingival recessions were included. Recessions were randomly treated according to a split-mouth design by means of CAF with oblique interdental incisions (OBL technique), or CAF with horizontal interdental incisions (HOR technique). Marginal gingival recession (REC), clinical attachment level (CAL), pocket probing depth (PPD), height of keratinized tissue (HKT), and thickness of keratinized tissue (TKT) were measured at baseline, and 3 and 6 months after treatment. Patient-centered outcomes concerning morbidity and improvement in the esthetic appearance were recorded using a visual analog scale (VAS). Both groups showed significant reductions in REC and gains in CAL throughout the study (P < .05). At 3 months, OBL-treated sites showed greater root coverage than HOR-treated sites (P < .05), although no intergroup differences were observed at 6 months (P > .05). There was an increase in HKT only in the OBL group at 6 months from baseline (P < .05). No differences between therapies were revealed concerning morbidity (P > .05), whereas a higher satisfaction with the esthetic appearance was reported for the OBL technique 6 months postsurgery (P < .05). Although both surgical approaches may provide satisfactory root coverage, use of the OBL technique promoted additional benefits in terms of esthetic perception after the management of multiple gingival recessions.

  5. Treatment Prices at the Point of Care in a Clinical Oncology Service: Pilot Project.

    PubMed

    Henrikson, Nora B; Lau, Rebecca W; Tuzzio, Leah; Christianson, Matthew; Phan, Thanh-Hien; Chen, Eric

    2016-10-01

    Patients with cancer increasingly wish to discuss cancer care costs with clinicians. We aimed to improve clinician access to treatment prices. We developed a pilot tool and accompanying workflow for four oncology clinics in an integrated care system. The online tool included 50 printable worksheets for cancer treatment protocols and was accessible directly from the electronic health record. Each sheet included codes and prices for all drugs and services for one treatment cycle in patient-friendly language. The worksheets did not provide patient-level cost-shares. We evaluated the resource's launch, initial use, and acceptability through a convenience survey of initial users. The project was successfully launched. Initial Web traffic to price sheets exceeded the number of treatments ordered during the launch period. One third of survey respondents reported use of the cost sheets at least once a week. The most useful features were improved access to cost information, treatment protocol-based layout, and ability to meet patient needs. The resource was rated as generally high value to patients, staff, and the organization. Suggested improvements included provision of patient-level cost sharing (63%) followed by expansion of the project to include more protocols (33%). These improvements are in progress. The pilot was feasible, built capacity to locate price data, and did not adversely affect staff workload. It addressed a clear need and demonstrated high potential overall value, especially with its protocol-based format. The resource's lack of personalized estimates of out-of-pocket charges was the biggest gap reported.

  6. Eccentric treatment for patellar tendinopathy: a prospective randomised short‐term pilot study of two rehabilitation protocols

    PubMed Central

    Frohm, Anna; Saartok, Tönu; Halvorsen, Kjartan; Renström, Per

    2007-01-01

    Objective To compare the efficacy and safety of two eccentric rehabilitation protocols for patients with symptomatic patellar tendinopathy. A new eccentric overload training device was compared with the present standard eccentric rehabilitation programme on a decline board. Design Prospective, randomised clinical trial. Setting Sports rehabilitation clinic, university sports laboratory, supplemented with home exercises. Patients 20 competitive and recreational athletes, all with clinical diagnosis of patellar tendinopathy, verified by MRI or ultrasound imaging. Interventions A 12‐week rehabilitation period, either with bilateral eccentric overload strength training using the Bromsman device twice a week or with unilateral eccentric body load training using a decline board twice a week, supplemented with daily home exercises. Outcome measures The primary outcome was pain and function, assessed by the Swedish Victorian Institute of Sport Assessment for Patella (VISA‐P) score. Secondary outcome measures were isokinetic muscle torque, dynamic function and muscle flexibility, as well as pain level estimations using visual analogue scale (VAS). Side effects were registered. Results Both treatment groups improved in the short term according to the VISA‐P scores during the 12‐week rehabilitation period. However, there were no significant differences between the groups in terms of pain and function. After a 3‐month rehabilitation period, most patients could be regarded as improved enough to be able to return to training and sports. No serious side effects were detected in either group. Conclusion In patients with patellar tendinopathy pain, two‐legged eccentric overload training twice per week, using the new device (Bromsman), was as efficient and safe as the present standard daily eccentric one‐legged rehabilitation‐training regimen using a decline board. PMID:17289855

  7. Efficacy of cognitive behavioural therapy for sleep improvement in patients with persistent delusions and hallucinations (BEST): a prospective, assessor-blind, randomised controlled pilot trial

    PubMed Central

    Freeman, Daniel; Waite, Felicity; Startup, Helen; Myers, Elissa; Lister, Rachel; McInerney, Josephine; Harvey, Allison G; Geddes, John; Zaiwalla, Zenobia; Luengo-Fernandez, Ramon; Foster, Russell; Clifton, Lei; Yu, Ly-Mee

    2015-01-01

    Summary Background Sleep disturbance occurs in most patients with delusions or hallucinations and should be treated as a clinical problem in its own right. However, cognitive behavioural therapy (CBT)—the best evidence-based treatment for insomnia—has not been tested in this patient population. We aimed to pilot procedures for a randomised trial testing CBT for sleep problems in patients with current psychotic experiences, and to provide a preliminary assessment of potential benefit. Methods We did this prospective, assessor-blind, randomised controlled pilot trial (Better Sleep Trial [BEST]) at two mental health centres in the UK. Patients (aged 18–65 years) with persistent distressing delusions or hallucinations in the context of insomnia and a schizophrenia spectrum diagnosis were randomly assigned (1:1), via a web-based randomisation system with minimisation to balance for sex, insomnia severity, and psychotic experiences, to receive either eight sessions of CBT plus standard care (medication and contact with the local clinical team) or standard care alone. Research assessors were masked to group allocation. Assessment of outcome was done at weeks 0, 12 (post-treatment), and 24 (follow-up). The primary efficacy outcomes were insomnia assessed by the Insomnia Severity Index (ISI) and delusions and hallucinations assessed by the Psychotic Symptoms Rating Scale (PSYRATS) at week 12. We did analysis by intention to treat, with an aim to provide confidence interval estimation of treatment effects. This study is registered with ISRCTN, number 33695128. Findings Between Dec 14, 2012, and May 22, 2013, and Nov 7, 2013, and Aug 26, 2014, we randomly assigned 50 patients to receive CBT plus standard care (n=24) or standard care alone (n=26). The last assessments were completed on Feb 10, 2015. 48 (96%) patients provided follow-up data. 23 (96%) patients offered CBT took up the intervention. Compared with standard care, CBT led to reductions in insomnia in the large

  8. Efficacy of cognitive behavioural therapy for sleep improvement in patients with persistent delusions and hallucinations (BEST): a prospective, assessor-blind, randomised controlled pilot trial.

    PubMed

    Freeman, Daniel; Waite, Felicity; Startup, Helen; Myers, Elissa; Lister, Rachel; McInerney, Josephine; Harvey, Allison G; Geddes, John; Zaiwalla, Zenobia; Luengo-Fernandez, Ramon; Foster, Russell; Clifton, Lei; Yu, Ly-Mee

    2015-11-01

    Sleep disturbance occurs in most patients with delusions or hallucinations and should be treated as a clinical problem in its own right. However, cognitive behavioural therapy (CBT)-the best evidence-based treatment for insomnia-has not been tested in this patient population. We aimed to pilot procedures for a randomised trial testing CBT for sleep problems in patients with current psychotic experiences, and to provide a preliminary assessment of potential benefit. We did this prospective, assessor-blind, randomised controlled pilot trial (Better Sleep Trial [BEST]) at two mental health centres in the UK. Patients (aged 18-65 years) with persistent distressing delusions or hallucinations in the context of insomnia and a schizophrenia spectrum diagnosis were randomly assigned (1:1), via a web-based randomisation system with minimisation to balance for sex, insomnia severity, and psychotic experiences, to receive either eight sessions of CBT plus standard care (medication and contact with the local clinical team) or standard care alone. Research assessors were masked to group allocation. Assessment of outcome was done at weeks 0, 12 (post-treatment), and 24 (follow-up). The primary efficacy outcomes were insomnia assessed by the Insomnia Severity Index (ISI) and delusions and hallucinations assessed by the Psychotic Symptoms Rating Scale (PSYRATS) at week 12. We did analysis by intention to treat, with an aim to provide confidence interval estimation of treatment effects. This study is registered with ISRCTN, number 33695128. Between Dec 14, 2012, and May 22, 2013, and Nov 7, 2013, and Aug 26, 2014, we randomly assigned 50 patients to receive CBT plus standard care (n=24) or standard care alone (n=26). The last assessments were completed on Feb 10, 2015. 48 (96%) patients provided follow-up data. 23 (96%) patients offered CBT took up the intervention. Compared with standard care, CBT led to reductions in insomnia in the large effect size range at week 12 (adjusted

  9. Pilot study demonstrating effectiveness of targeted education to improve informed consent understanding in AIDS clinical trials.

    PubMed

    Sengupta, Sohini; Lo, Bernard; Strauss, Ronald P; Eron, Joseph; Gifford, Allen L

    2011-11-01

    Assessing and improving informed consent understanding is equally important as obtaining consent from participants in clinical trial research, but developing interventions to target gaps in participants' informed consent understanding remains a challenge. We used a randomized controlled study design to pilot test an educational intervention to improve actual informed consent understanding of new enrollees in the Adult AIDS Clinical Trial Group (AACTG). Questionnaires were administered to 24 enrollees to assess their baseline understanding on eight elements of informed consent associated with AIDS clinical trials. Enrollees who scored 18/21(85%) or less were randomly assigned to in-person, targeted education (intervention), or delayed education (control). Two follow-up assessments were administered. Repeated measures ANOVA was performed to determine intervention effectiveness in improving actual informed consent understanding over time. Actual understanding improved at the immediate post-intervention time point with a significant score difference of 2.5 when comparing the intervention and delayed groups. In addition, there was a significant score difference of 3.2 when comparing baseline to three-month follow-up for the two groups, suggesting a statistically significant intervention effect to improve actual understanding of the basic elements of informed consent. The findings demonstrated that one-time targeted education can improve actual informed consent understanding one week after the intervention, but retention of these concepts may require periodic monitoring to ensure comprehension throughout the course of a clinical trial.

  10. Single-cell genomic profiling of acute myeloid leukemia for clinical use: A pilot study.

    PubMed

    Yan, Benedict; Hu, Yongli; Ban, Kenneth H K; Tiang, Zenia; Ng, Christopher; Lee, Joanne; Tan, Wilson; Chiu, Lily; Tan, Tin Wee; Seah, Elaine; Ng, Chin Hin; Chng, Wee-Joo; Foo, Roger

    2017-03-01

    Although bulk high-throughput genomic profiling studies have led to a significant increase in the understanding of cancer biology, there is increasing awareness that bulk profiling approaches do not completely elucidate tumor heterogeneity. Single-cell genomic profiling enables the distinction of tumor heterogeneity, and may improve clinical diagnosis through the identification and characterization of putative subclonal populations. In the present study, the challenges associated with a single-cell genomics profiling workflow for clinical diagnostics were investigated. Single-cell RNA-sequencing (RNA-seq) was performed on 20 cells from an acute myeloid leukemia bone marrow sample. Putative blasts were identified based on their gene expression profiles and principal component analysis was performed to identify outlier cells. Variant calling was performed on the single-cell RNA-seq data. The present pilot study demonstrates a proof of concept for clinical single-cell genomic profiling. The recognized limitations include significant stochastic RNA loss and the relatively low throughput of the current proposed platform. Although the results of the present study are promising, further technological advances and protocol optimization are necessary for single-cell genomic profiling to be clinically viable.

  11. Effect of a Pilot Preclinical Incentive Program on Dental Students' Performance on a Clinical Competency Exam.

    PubMed

    Schuster, Gregory M; Hunt, Ronald J; Haering, Harold J

    2017-01-01

    The aim of this study was to investigate the effect of a pilot preclinical incentive program on dental students' performance on a clinical competency (mock board) exam at Midwestern University College of Dental Medicine-Arizona. To assess the effect of preclinical grade incentives in a program called SUCCEED, scores from a clinical competency exam administered during the fall quarter of the fourth year were compared between the graduating classes of 2014 and 2015 (pre-SUCCEED curriculum) and the graduating class of 2016 (post-SUCCEED curriculum). The study hypothesized that the class participating in the SUCCEED program, with its incentives for greater preclinical preparation and practice, would score higher than the other classes on the exams. The results showed that the endodontics and periodontics pass rates and test scores from the Class of 2016 were higher than those from the Classes of 2014 and 2015; the prosthodontics pass rates were similar; and the operative dentistry pass rates and test scores were lower than the Classes of 2014 and 2015. While the results of two of the four subsections of the competency exam showed an improvement in clinical performance for the Class of 2016, the operative dentistry test scores for that class were less than expected. Based on the increased number of operative dentistry procedures performed in preclinical simulation and the clinic, the authors conclude that the competency exam should not be the only measure to evaluate success of the SUCCEED program.

  12. Off-pump Versus On-pump Coronary Artery Bypass Surgery: Graft Patency Assessment With Coronary Computed Tomographic Angiography: A Prospective Multicenter Randomized Controlled Pilot Study.

    PubMed

    Noiseux, Nicolas; Stevens, Louis-Mathieu; Chartrand-Lefebvre, Carl; Soulez, Gilles; Prieto, Ignacio; Basile, Fadi; Mansour, Samer; Dyub, Adel M; Kieser, Teresa M; Lamy, André

    2017-06-05

    A large multicenter randomized trial (RCT) is needed to assess off-pump coronary artery bypass graft (CABG) patency when performed by skilled surgeons. This prospective multicenter randomized pilot study compares graft patency after on-pump and off-pump techniques and addresses the feasibility of such an RCT. Consecutive patients were prospectively recruited for ≥64-slice computed tomography angiography graft patency assessment 1 year after randomization to off-pump or on-pump CABG. Blinded assessment of graft patency was performed, and the results were categorized as normal, ≥50% stenosis, or occlusion. A multilevel model with random effects on the patient was used to account for correlation of results in patients with multiple grafts. A total of 157 patients (3 centers, 84 off-pump and 73 on-pump patients, 512 grafts, assessability rate 98.4%) were included. Patency index (% nonoccluded grafts) was 89% for the off-pump technique and 95% for the on-pump technique (P=0.09). Patency was similar for arterial and vein grafts (both 92%; P=0.88), as well as between target territories (89% to 94%; P=0.53). In this pilot study, 1-year graft patency results after off-pump and on-pump surgery were similar. This feasibility trial demonstrates that a large multicenter RCT to compare CABG patency after on-pump with that after off-pump techniques is feasible and can be reliably undertaken using computed tomography angiography.

  13. Development, Implementation, and Evaluation of a Pilot Parenting Educational Intervention in a Pregnancy Buprenorphine Clinic.

    PubMed

    Giles, Averie C; Ren, Dianxu; Founds, Sandra

    2016-01-01

    We developed a pilot evidence-based prenatal educational intervention to increase knowledge of neonatal abstinence syndrome (NAS) and early parenting skills for women with opiate dependency who enrolled in a pregnancy buprenorphine clinic. We developed, implemented, and tested modules regarding expectations during newborn hospitalization for observation or treatment of NAS and regarding evidence-based parenting skills in response to NAS behaviors. Testing evaluated baseline knowledge of early parenting skills with newborns at risk for NAS and change from baseline after the educational intervention. No statistically significant difference in composite knowledge scores was observed. A brief survey completed by the participants postpartum affirmed the perception of women that the educational intervention effectively prepared them for the early postpartum period while their newborns were hospitalized.

  14. Pilot clinical application of an adaptive robotic system for young children with autism

    PubMed Central

    Bekele, Esubalew; Crittendon, Julie A; Swanson, Amy; Sarkar, Nilanjan; Warren, Zachary E

    2013-01-01

    It has been argued that clinical applications of advanced technology may hold promise for addressing impairments associated with autism spectrum disorders. This pilot feasibility study evaluated the application of a novel adaptive robot-mediated system capable of both administering and automatically adjusting joint attention prompts to a small group of preschool children with autism spectrum disorders (n = 6) and a control group (n = 6). Children in both groups spent more time looking at the humanoid robot and were able to achieve a high level of accuracy across trials. However, across groups, children required higher levels of prompting to successfully orient within robot-administered trials. The results highlight both the potential benefits of closed-loop adaptive robotic systems as well as current limitations of existing humanoid-robotic platforms. PMID:24104517

  15. PDA-assisted simulated clinical experiences in undergraduate nursing education: a pilot study.

    PubMed

    Schlairet, Maura C

    2012-01-01

    Descriptive literature on use of personal digital assistants (PDAs) in nursing education exists; but, quantitative outcome-driven studies of efficacy are lacking. Few studies have explored the integration of technologies like simulated clinical experiences (SCEs) with informatics competencies. The purpose of this pilot study was to determine if nursing students' knowledge and attitude scores following a PDA-assisted SCE would be equivalent to textbook-assisted scores. Using a convenience sample of first-semester baccalaureate students and an equivalence design, multiple lessons were learned about the use of PDAs in the context of SCE. Learning was supported through use of PDAs in place of traditional text references; students viewed PDAs as beneficial resources in the provision of care; PDA use prompted reflection and triggered important need-learning connections; orientation to the use of PDAs promoted positive student attitudes; and use of PDAs helped meet nursing informatics curricular requirements.

  16. Pilot test of a three-station palliative care observed structured clinical examination for multidisciplinary trainees.

    PubMed

    Corcoran, Amy M; Lysaght, Susan; Lamarra, Denise; Ersek, Mary

    2013-05-01

    Developing effective communication and symptom assessment skills is an important component of palliative care training for advance practice nurses (APNs) and other health care providers. The purpose of this project was to develop and pilot test a three-station palliative care Observed Structured Clinical Examination (OSCE) for APN students and physician fellows. Three stations included discussing goals of care, breaking bad news, and assessing delirium. Measures included the Interpersonal Skills Tool, Station Checklists, the OSCE Evaluation Tool, and a focus group to solicit learners' perspectives about the experience. Findings showed that learners evaluated the exercise as appropriate for their level of training and that standardized patients were convincing and provided helpful feedback. Learner self-evaluation means were significantly lower than those of standardized patient or faculty, and faculty raters demonstrated low interrater reliability. Initial evaluation suggests a three-station palliative care OSCE exercise is effective for multidisciplinary learners, although additional refinement is necessary. Copyright 2013, SLACK Incorporated.

  17. Prospective derivation and validation of a clinical prediction rule for recurrent Clostridium difficile infection.

    PubMed

    Hu, Mary Y; Katchar, Kianoosh; Kyne, Lorraine; Maroo, Seema; Tummala, Sanjeev; Dreisbach, Valley; Xu, Hua; Leffler, Daniel A; Kelly, Ciarán P

    2009-04-01

    Prevention of recurrent Clostridium difficile infection (CDI) is a substantial therapeutic challenge. A previous prospective study of 63 patients with CDI identified risk factors associated with recurrence. This study aimed to develop a prediction rule for recurrent CDI using the above derivation cohort and prospectively evaluate the performance of this rule in an independent validation cohort. The clinical prediction rule was developed by multivariate logistic regression analysis and included the following variables: age>65 years, severe or fulminant illness (by the Horn index), and additional antibiotic use after CDI therapy. A second rule combined data on serum concentrations of immunoglobulin G (IgG) against toxin A with the clinical predictors. Both rules were then evaluated prospectively in an independent cohort of 89 patients with CDI. The clinical prediction rule discriminated between patients with and without recurrent CDI, with an area under the curve of the receiver-operating-characteristic curve of 0.83 (95% confidence interval [CI]: 0.70-0.95) in the derivation cohort and 0.80 (95% CI: 0.67-0.92) in the validation cohort. The rule correctly classified 77.3% (95% CI: 62.2%-88.5%) and 71.9% (95% CI: 59.2%-82.4%) of patients in the derivation and validation cohorts, respectively. The combined rule performed well in the derivation cohort but not in the validation cohort (area under the curve of the receiver-operating-characteristic curve, 0.89 vs 0.62; diagnostic accuracy, 93.8% vs 69.2%, respectively). We prospectively derived and validated a clinical prediction rule for recurrent CDI that is simple, reliable, and accurate and can be used to identify high-risk patients most likely to benefit from measures to prevent recurrence.

  18. Impact of a clinical pharmacist on a cardiovascular surrogate endpoint: a pilot study

    PubMed Central

    Ripley, Toni L.; Hennebry, Thomas A.; Sanders, Tiffany N.; Harrison, Donald; Rathbun, R. Chris

    Utilizing a multidisciplinary approach to management of patients with certain chronic cardiovascular diseases (CVD) has been shown to improve treatment outcomes. The role of clinical pharmacists in comprehensive outpatient CVD management has not been evaluated. Objective The objective of this pilot study was to evaluate the impact of a clinical pharmacist added to cardiologist care on blood pressure (BP), a key surrogate marker of CVD, in outpatients with CVD compared to cardiologist care alone. Methods A retrospective, matched-control study was conducted in patients established in a cardiovascular clinic. The intervention was referral to a pharmacist clinic; control was usual care from the cardiologist. The surrogate marker evaluated was the change in BP. Results Patients in the pharmacist-intervention (n=57) experienced significant reductions in diastolic BP (-2.6 mmHg, p=0.05) and non-significant reductions in systolic BP (-4.3 mmHg, p=0.16) compared to baseline, whereas patients in the control group experienced non-significant increases in both systolic and diastolic BP (+1.6/+0.7 mmHg, p=NS). Similarly, there were significant reductions in diastolic BP and non-significant reductions in systolic BP for the intervention group when compared to controls (difference 3.3 mmHg, p=0.04 and 5.9 mmHg, p=0.1, respectively). Lastly, the proportion of patients categorized as having Stage 2 BP was significantly reduced in the intervention group (p=0.02), but not in the controls (p=0.5). Conclusions The multidisciplinary model of care that included a clinical pharmacist reduced BP more than usual care by a cardiologist alone. This benefit was demonstrated in complex patients with CVD who were already receiving specialized care. The impact of this model on clinical outcomes requires further evaluation and should be a high priority given the burden of CVD in the population. PMID:24155834

  19. Relationship of neuroimaging to typical sleep times during a clinical reasoning task: a pilot study.

    PubMed

    Durning, Steven J; Kelly, William; Costanzo, Michelle E; Artino, Anthony R; van der Vleuten, Cees; Beckman, Thomas J; Roy, Michael J; Holmboe, Eric S; Wittich, Christopher M; Schuwirth, Lambert

    2015-04-01

    Sleep deprivation and fatigue have been associated with medical errors, clinical performance decrements, and reduced quality of life for both practicing physicians and medical students. Greater understanding of the impact of sleep quantity on clinical reasoning could improve patient care. The purpose of our pilot study was to examine relationships between clinical reasoning (assessed by functional magnetic resonance imaging) and sleep time (measured in different ways by actigraphy) while answering multiple-choice questions (MCQs) from licensing agencies. Residents and faculty were administered a clinical reasoning exercise (MCQs from licensing bodies) during functional magnetic resonance imaging. Usual sleep patterns were sampled with actigraphy. Covariate analysis was used to examine the relationship between sleep duration (mean sleep, minimum sleep, maximum sleep) and brain activity during clinical reasoning (solving MCQs from licensing bodies). The mean sleep time over the duration of monitoring for the group was 7.19 hours (SD 0.66) with a range of 6.1 to 8.1 hours (internal medicine faculty 7.1 hours, SD 0.41; internal medicine residents 7.27 hours, SD 0.92). There was a negative relationship between activation in the prefrontal cortex and minimum sleep time while reflecting on MCQs. Our findings provide evidence that the quantity of sleep can modulate brain activity while completing a clinically meaningful task that should be confirmed in larger studies. Our findings suggest that the construct of sleepiness may be more complex than appreciated by many and that the most important of these sleep measures in terms of outcomes remains to be determined. Reprint & Copyright © 2015 Association of Military Surgeons of the U.S.

  20. Trigeminal neuralgia--a prospective systematic study of clinical characteristics in 158 patients.

    PubMed

    Maarbjerg, Stine; Gozalov, Aydin; Olesen, Jes; Bendtsen, Lars

    2014-01-01

    To prospectively describe the clinical characteristics of classical trigeminal neuralgia (TN) in a standardized manner. TN is a rare disease and most clinicians only see a few patients. There is a lack of prospective systematic studies of the clinical characteristics of TN. We hypothesized that contrary to current thinking, some TN patients suffer from sensory abnormalities at neurological examination. Clinical characteristics such as demographics, pain characteristics, and comorbidities were systematically and prospectively collected from consecutive TN patients in a tertiary referral center in a cross-sectional study. A total of 158 patients were included. Average age of onset was 52.9 years. TN was more prevalent in women (95; 60%) than in men (63; 40%), P = .011, and more often located on the right (89; 56%) than on the left side (64; 41%), P = .043. It affected solely the second and/or third trigeminal branch in 109 (69%) while the first branch alone was affected in only 7 (4%). Notably, 78 (49%) had concomitant persistent pain in addition to paroxysmal stabbing pain. Autonomic symptoms were present in 48 (31%). Patients who had not undergone surgery for TN had sensory abnormalities in 35 (29%). This, the first study in a series of papers focusing on the clinical, radiological, and etiological aspects of TN, revealed that the symptomatology of TN includes a high percentage of concomitant persistent pain, autonomic symptoms, and sensory abnormalities. These findings offer new insights to the prevailing clinical impression of the clinical characteristics in TN. © 2014 American Headache Society.

  1. Laparoscopic Surgical Treatment of Severe Obesity Combined with Gastroesophageal Reflux Disease: A Pilot Randomized Two-Arm Controlled Clinical Study

    ERIC Educational Resources Information Center

    Ospanov, Oral B.; Orekeshova, Akzhunis M.; Fursov, Roman A.; Yelemesov, Aset A.

    2016-01-01

    Obesity and gastroesophageal reflux disease (GERD) are serious medical, social, and economic problems of modern society. A pilot randomized two-arm controlled clinical study was conducted to compare laparoscopic plication of the greater gastric curvature combined with Nissen fundoplication (LFN+LGP) versus only Nissen fundoplication (LFN). The…

  2. Feasibility of Providing Culturally Relevant, Brief Interpersonal Psychotherapy for Antenatal Depression in an Obstetrics Clinic: A Pilot Study

    ERIC Educational Resources Information Center

    Grote, Nancy K.; Bledsoe, Sarah E.; Swartz, Holly A.; Frank, Ellen

    2004-01-01

    Objective: To minimize barriers to care, ameliorate antenatal depression, and prevent postpartum depression, we conducted a pilot study to assess the feasibility of providing brief interpersonal psychotherapy (IPT-B) to depressed, pregnant patients on low incomes in an obstetrics and gynecological (OB/GYN) clinic. Method: Twelve pregnant,…

  3. Feasibility of Providing Culturally Relevant, Brief Interpersonal Psychotherapy for Antenatal Depression in an Obstetrics Clinic: A Pilot Study

    ERIC Educational Resources Information Center

    Grote, Nancy K.; Bledsoe, Sarah E.; Swartz, Holly A.; Frank, Ellen

    2004-01-01

    Objective: To minimize barriers to care, ameliorate antenatal depression, and prevent postpartum depression, we conducted a pilot study to assess the feasibility of providing brief interpersonal psychotherapy (IPT-B) to depressed, pregnant patients on low incomes in an obstetrics and gynecological (OB/GYN) clinic. Method: Twelve pregnant,…

  4. Training Opioid Addiction Treatment Providers to Adopt Contingency Management: A Prospective Pilot Trial of a Comprehensive Implementation Science Approach

    PubMed Central

    Becker, Sara J.; Squires, Daniel D.; Strong, David R.; Barnett, Nancy P.; Monti, Peter M.; Petry, Nancy M.

    2016-01-01

    Background Few prospective studies have evaluated theory-driven approaches to the implementation of evidence-based opioid treatment. This study compared the effectiveness of an implementation model (Science to Service Laboratory; SSL) to training as usual (TAU) in promoting the adoption of contingency management across a multi-site opiate addiction treatment program. We also examined whether the SSL affected putative mediators of contingency management adoption (perceived innovation characteristics and organizational readiness to change). Methods Sixty treatment providers (39 SSL, 21 TAU) from 15 geographically diverse satellite clinics (7 SSL, 8 TAU) participated in the 12-month study. Both conditions received didactic contingency management training and those in the pre-determined experimental region received 9 months of SSL-enhanced training. Contingency management adoption was monitored biweekly, while putative mediators were measured at baseline, 3-, and 12-months. Results Relative to providers in the TAU region, treatment providers in the SSL region had comparable likelihood of contingency management adoption in the first 20 weeks of the study, and then significantly higher likelihood of adoption (odds ratios = 2.4-13.5) for the remainder of the study. SSL providers also reported higher levels of one perceived innovation characteristic (Observability) and one aspect of organizational readiness to change (Adequacy of Training Resources), although there was no evidence that the SSL affected these putative mediators over time. Conclusions Results of this study indicate that a fully powered randomized trial of the SSL is warranted. Considerations for a future evaluation are discussed. PMID:26682582

  5. Why clinical nurse educators adopt innovative teaching strategies: a pilot study.

    PubMed

    Phillips, Janet M; Vinten, Sharon A

    2010-01-01

    The purpose of this pilot study was to describe intentions to adopt innovative teaching strategies in clinical educators who have participated in an online course focusing on the role of clinical teaching (N = 71). Innovative teaching strategies were defined as those that embrace the tenets of sociocultural theory, a student-centered approach whereby the role of the nurse educator is to motivate and support the student and, in mutual process, to push students to reach toward their learning potential by using guiding techniques that can be erected or gradually reduced based on the individual student's learning needs. Participants stated that three factors proposed in the Rogers theory of diffusion of innovation (compatibility, trialability, and relative advantage) would be most influential in the adoption of innovative teaching strategies. Encouraging students to explore and apply new knowledge was described as the teaching strategy most likely to be adopted. Intent to adopt innovative teaching strategies may provide insight into the development of organizational climates in schools of nursing that could foster needed changes in clinical teaching.

  6. Application and student evaluation of a Clinical Progression Portfolio: a pilot.

    PubMed

    Cooke, Marie; Mitchell, Marion; Moyle, Wendy; Henderson, Amanda; Murfield, Jenny

    2010-07-01

    Clinical practicums are often limited by a lack of meaningful communication between nursing students and registered nurses (RNs). This pilot study evaluated the utility of the Clinical Progression Portfolio (CPP) to enable students to learn how to initiate engagement with their RNs and to develop their capacity as students to learn. The study employed a descriptive survey design, with a convenience sample of second-year Bachelor of Nursing (BN) students in Brisbane, Australia. Questionnaires were completed by 129 students from 20 clinical practicum groups. Students who used the CPP were more favourable in their usefulness ratings (-rpb=0.531, p<0.001) and, furthermore, those that used the CPP most frequently were also more favourable (r=0.555, p<0.001). Students thought the CPP helped clarify learning and target appropriate practicum opportunities. When used, the CPP was an important part of practicum, used frequently and considered useful. The CPP format met the needs of students as it was pocket-sized. Overall, students reported that the CPP was a useful learning and communication tool as it provided them direction in how they might maximise opportunities to address their learning needs. Copyright 2009 Elsevier Ltd. All rights reserved.

  7. Women's Health Care Minimum Data Set: pilot test and validation for use in clinical practice.

    PubMed

    Farley, Cindy L; Tharpe, Nell; Miller, Liane; Ruxer, Debbie Jenkins

    2006-01-01

    Basic elements of the structure, process, and outcomes of midwifery practice have not been fully determined, particularly in the areas of women's gynecologic and primary health care. The American College of Nurse-Midwives (ACNM) supported the development of clinical data sets to describe structure, process, and outcomes of midwifery practice for use by clinical practitioners. The Woman's Health Care Minimum Data Set was developed using a panel of expert midwives and other women's health care professionals, as well as literature resources. Students of the Graduate Midwifery Program at Philadelphia University performed pilot testing of the Woman's Health Care Minimum Data Set as a service to the profession of midwifery while applying concepts learned in their research methods courses. Each student (n = 19) recruited a midwifery practice in which she had a clinical affiliation, and gathered data sets on the previous 30 consecutive women's health care encounters by CNMs or CMs (n = 569). Item analysis and refinement were done. Criterion-related validity and construct-related validity of the Woman's Health Care Minimum Data Set were explored through comparison with the medical record and through the testing of plausible hypotheses. The Woman's Health Care Minimum Data Set has the potential to be an important instrument in documenting and understanding the evolving nature of the practice of primary women's health care by midwives and other women's health care providers.

  8. Critical thinking and clinical decision making in critical care nursing: a pilot study.

    PubMed

    Hicks, Frank D; Merritt, Sharon L; Elstein, Arthur S

    2003-01-01

    This pilot study examined the relationship of education level, years of critical care nursing experience, and critical thinking (CT) ability (skills and dispositions) to consistency in clinical decision making among critical care nurses. Consistency was defined as the degree to which intuitive and analytical decision processes resulted in similar selection of interventions in tasks of low and high complexity. The study was nonexperimental and correlational. Critical care nurses (n = 54) from adult critical care units in 3 private teaching hospitals. The majority of nurses held a BSN or MSN and had an average of 9 years of direct clinical experience in the care of the critically ill. Decision-making consistency decreased significantly between low-complexity and high-complexity tasks. Both intuitive and analytical decision processes produced clear intervention selections in the low-complexity task, although the analytical process resulted in a more complete specification of interventions. In the high-complexity task, however, only the intuitive process resulted in a clear, plausible, and safe specification of interventions. Education and experience were not related to CT ability, nor was CT ability related to decision-making consistency. Only greater years of critical care nursing experience increased the likelihood of decision-making consistency. Overall, intuitive decision processes resulted in more clinically consistent selection of interventions across tasks. More investigation is needed to examine the influence of decision heuristics, and the conceptualization and measurement of CT abilities among practicing nurses.

  9. Clinical and neuropsychiatric correlates of lumbar spinal surgery in older adults: results of a pilot study.

    PubMed

    Karp, Jordan F; McGovern, Jonathan; Marron, Megan M; Gerszten, Peter; Weiner, Debra K; Okonkwo, David; Kanter, Adam S

    2016-11-01

    To improve selection of older lumbar surgical candidates, we surveyed correlates of functioning and satisfaction with surgery. Prospective sample at lumbar spine surgery clinic. Patients (n = 48) were evaluated before surgery and after 3 months. Dependent variables were functioning and surgical satisfaction. Baseline variables associated with disability at 3 months included cognitive status and widespread pain. There was clinically significant improvement with moderate effects sizes for anxiety and depression at follow-up. Patients with at least a 30% improvement in disability had better physical health-related quality of life and were less likely to report widespread pain before surgery. Although preliminary, two novel potential predictors of lumbar surgery outcome include diminished cognitive functioning and widespread pain. Further study of these variables on post-surgical functioning and satisfaction may improve patient selection.

  10. Acupuncture for nasal congestion: a prospective, randomized, double-blind, placebo-controlled clinical pilot study.

    PubMed

    Sertel, Serkan; Bergmann, Zazie; Ratzlaff, Kerstin; Baumann, Ingo; Greten, Henry Johannes; Plinkert, Peter Karl

    2009-01-01

    Nasal congestion is one of the most common complaints dealt with in otorhinolaryngology. Side effects of decongestants are frequently seen in patients with chronic nasal congestion. This leads to an increasing demand of alternative treatments such as acupuncture. Future studies on acupuncture should aim at objectifying effects by both physical measuring and double blinding. Therefore, we were interested in whether these effects can potentially be measured as increase in nasal airflow (NAF) in ventus ("wind") disease of traditional Chinese medicine (TCM). Twenty-four patients with a history of nasal congestion due to hypertrophic inferior turbinates or chronic sinusitis without polyposis were additionally diagnosed according to the Heidelberg model of TCM. They were asked to score the severity of their nasal congestion on a visual analog scale (VAS). The acupuncturist was blinded according to the Heidelberg blinding assay. NAF was measured by using active anterior rhinomanometry (ARM). Specific verum acupoints according to the Chinese medical diagnosis were tested against nonspecific control acupoints. VAS and NAF were scored and measured before and 15 and 30 minutes after acupuncture. Control acupuncture showed a significant improvement in VAS and a deterioration of NAF. Verum acupuncture showed highly significant improvements in VAS and NAF. In addition, verum acupuncture improved NAF and VAS significantly over time. Our control and verum acupoints fulfill the condition of a control and verum treatment, respectively. Measuring NAF by RRM and scoring VAS are possible and reflect acupuncture effects in vivo.

  11. Effects of an estrogen-free, desogestrel-containing oral contraceptive in women with migraine with aura: a prospective diary-based pilot study.

    PubMed

    Nappi, Rossella E; Sances, Grazia; Allais, Gianni; Terreno, Erica; Benedetto, Chiara; Vaccaro, Valentina; Polatti, Franco; Facchinetti, Fabio

    2011-03-01

    Migraine with aura (MA) is a contraindication to the use of combined oral contraceptives (COCs) because of the increased risk of ischemic stroke. Progestogen-only contraceptive pill (POP) is a safe alternative to COCs and it is preferable in women with cerebrovascular diseases or risk factors for stroke. Prospective diary-based pilot study. Thirty women with MA (n = 15 who have never used COCs and n = 15 who had previously used COCs were diagnosed according to the International Headache Society criteria. The observational period lasted 9 months during which women filled in a diary with the clinical characteristics of headache attacks. After a 3-month run-in period, each subject received an estrogen-free desogestrel (DSG) (75 mcg/day)-containing OC (Cerazette(®); Schering-Plough, formerly NV Organon, Oss, The Netherlands). Follow-up evaluations were planned at the end of the third and sixth month of treatment. The number (mean±S.D.) of migraine attacks was significantly reduced both in previous COCs users (from 3.9±1.0 to 2.9±0.8; p<.001) and nonusers (from 3.2±0.9 to 2.6±1.3; p<.02) following 6 months of POP use in comparison with the run-in period. Duration of headache pain did not differ significantly in both groups throughout the study. Interestingly enough, a beneficial POP effect on the duration (mean±S.D.) of visual aura (from 16.3±9.5 to 11.4±5.6 min) and on the total duration (mean±S.D.) of neurological symptoms (from 33.6±23.3 to 18.6±18.0 min) was only significantly reported by previous COCs users (p<.001, for both) by the end of the study period. The POP was well tolerated by each woman and the bleeding pattern was variable with a tendency towards infrequent bleeding. The present study supports the use of the POP containing desogestrel in a population of women with MA and underlines a positive effect on symptoms of aura, especially in MA sensitive to previous use of COCs. Copyright © 2011 Elsevier Inc. All rights reserved.

  12. Magnetic resonance imaging in the evaluation of clinical treatment of otospongiosis: a pilot study.

    PubMed

    de Oliveira Vicente, Andy; Chandrasekhar, Sujana S; Yamashita, Helio K; Cruz, Oswaldo Laercio M; Barros, Flavia A; Penido, Norma O

    2015-06-01

    To evaluate the applicability of magnetic resonance imaging (MRI) as a method for monitoring the activity of otospongiotic lesions before and after clinical treatment. Prospective, randomized, controlled, double-blind study. One single tertiary care institution in a large, cosmopolitan city. Twenty-six patients (n = 42 ears) with clinical, audiometric, and tomographic diagnosis of otosclerosis were enrolled. If computed tomography (CT) demonstrated active lesions, these patients underwent MRI to detect otospongiotic foci, seen as areas of gadolinium enhancement. Patients were divided into 3 groups and received treatment with placebo, sodium alendronate, or sodium fluoride for 6 months. After this period, clinical and audiometric evaluations and a second MRI were performed. Each MRI was evaluated by both a neuroradiologist and an otolaryngologist in a subjective (visual) and objective (using specific eFilm Workstation software) manner. Otospongiosis was most predominantly identified in the region anterior to the oval window, and this site was reliable for comparing pre- and posttreatment scans. The patients in the alendronate and sodium fluoride groups had MRI findings that suggested a decrease in activity of otospongiotic lesions, more relevant in the alendronate group. These findings were statistically significant for both subjective and objective MRI evaluations. MRI shows higher sensitivity than clinical or audiometric assessment for detecting reduction in activity of otospongiosis. The objective MRI evaluation based on software analysis was the most accurate method of monitoring clinical treatment response in otospongiosis. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2015.

  13. Markers of neuroinflammation and neuronal injury in bipolar disorder: Relation to prospective clinical outcomes.

    PubMed

    Isgren, Anniella; Sellgren, Carl; Ekman, Carl-Johan; Holmén-Larsson, Jessica; Blennow, Kaj; Zetterberg, Henrik; Jakobsson, Joel; Landén, Mikael

    2017-10-01

    Neuroimmune mechanisms have been linked to the pathophysiology of bipolar disorder based on studies of biomarkers in plasma, cerebrospinal fluid (CSF), and postmortem brain tissue. There are, however, no longitudinal studies investigating if CSF markers of neuroinflammation and neuronal injury predict clinical outcomes in patients with bipolar disorder. We have in previous studies found higher CSF concentrations of interleukin-8 (IL-8), monocyte chemoattractant protein 1 (MCP-1/CCL-2), chitinase-3-like protein 1 (CHI3L1/YKL-40), and neurofilament light chain (NF-L) in euthymic patients with bipolar disorder compared with controls. Here, we investigated the relationship of these CSF markers of neuroinflammation and neuronal injury with clinical outcomes in a prospective study. 77 patients with CSF analyzed at baseline were followed for 6-7years. Associations of baseline biomarkers with clinical outcomes (manic/hypomanic and depressive episodes, suicide attempts, psychotic symptoms, inpatient care, GAF score change) were investigated. Baseline MCP-1 concentrations were positively associated with manic/hypomanic episodes and inpatient care during follow-up. YKL-40 concentrations were negatively associated with manic/hypomanic episodes and with occurrence of psychotic symptoms. The prospective negative association between YKL-40 and manic/hypomanic episodes survived multiple testing correction. Concentrations of IL-8 and NF-L were not associated with clinical outcomes. High concentrations of these selected CSF markers of neuroinflammation and neuronal injury at baseline were not consistently associated with poor clinical outcomes in this prospective study. The assessed proteins may be involved in adaptive immune processes or reflect a state of vulnerability for bipolar disorder rather than being of predictive value for disease progression. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. A pilot project using evidence-based clinical pathways and payment reform in China's rural hospitals shows early success.

    PubMed

    Cheng, Tsung-Mei

    2013-05-01

    Reforming China's public hospitals to curb widespread overtreatment and improve the quality and affordability of care has been the most challenging aspect of that nation's ambitious health reform, which began in 2009. This article describes a pilot project under way in several of China's provinces that combines payment reform with the implementation of evidence-based clinical pathways at a few hospitals serving rural areas. Results to date include reduced length-of-stay and prescription drug use and higher patient and provider satisfaction. These early results suggest that the pilot may be achieving its goals, which may have far-reaching and positive implications for China's ongoing reform.

  15. Robotic pilot study for analysing spasticity: clinical data versus healthy controls.

    PubMed

    Seth, Nitin; Johnson, Denise; Taylor, Graham W; Allen, O Brian; Abdullah, Hussein A

    2015-12-02

    Spasticity is a motor disorder that causes significant disability and impairs function. There are no definitive parameters that assess spasticity and there is no universally accepted definition. Spasticity evaluation is important in determining stages of recovery. It can determine treatment effectiveness as well as how treatment should proceed. This paper presents a novel cross sectional robotic pilot study for the primary purpose of assessment. The system collects force and position data to quantify spasticity through similar motions of the Modified Ashworth Scale (MAS) assessment in the Sagittal plane. Validity of the system is determined based on its ability to measure velocity dependent resistance. Forty individuals with Acquired Brain Injury (ABI) and 45 healthy individuals participated in a robotic pilot study. A linear regression model was applied to determine the effect an ABI has on force data obtained through the robotic system in an effort to validate it. Parameters from the model were compared for both groups. Two techniques were performed in an attempt to classify between healthy and patients. Dynamic Time Warping (DTW) with k-nearest neighbour (KNN) classification is compared to a time-series algorithm using position and force data in a linear discriminant analysis (LDA). The system is capable of detecting a velocity dependent resistance (p<0.05). Differences were found between healthy individuals and those with MAS 0 who are considered to be healthy. DTW with KNN is shown to improve classification between healthy and patients by approximately 20 % compared to that of an LDA. Quantitative methods of spasticity evaluation demonstrate that differences can be observed between healthy individuals and those with MAS of 0 who are often clinically considered to be healthy. Exploiting the time-series nature of the collected data demonstrates that position and force together are an accurate predictor of patient health.

  16. Toward Meaningful Care Plan Clinical Decision Support: Feasibility and Effects of a Simulated Pilot Study.

    PubMed

    Keenan, Gail M; Lopez, Karen Dunn; Yao, Yingwei; Sousa, Vanessa E C; Stifter, Janet; Febretti, Alessandro; Johnson, Andrew; Wilkie, Diana J

    Clinical decision support (CDS) tools-with easily understood and actionable information, at the point of care-are needed to help registered nurses (RNs) make evidence-based decisions. Not clear are the optimal formats of CDS tools. Thorough, preclinical testing is desirable to avoid costly errors associated with premature implementation in electronic health records. The aims of this study were to determine feasibility of the protocol designed to compare multiple CDS formats and evaluate effects of numeracy and graph literacy on RN adoption of best practices and care planning time in a simulated environment. In this pilot study, 60 RNs were randomly assigned to one of four CDS conditions (control, text, text + graph, and text + table) and asked to adjust the plan of care for two patient scenarios over three shifts. Fourteen best practices were identified for the two patients and sent as suggestions with evidence to the three CDS groups. Best practice adoption rates, care planning time, and their relationship to the RN's numeracy and graph literacy scores were assessed. CDS groups had a higher adoption rate of best practices (p < .001) across all shifts and decreased care planning time in shifts 2 (p = .01) and 3 (p = .02) compared with the control group. Higher numeracy and graph literacy were associated with shorter care planning times under text + table (p = .05) and text + graph (p = .01) conditions. No significant differences were found between the three CDS groups on adoption rate and care planning time. This pilot study shows the feasibility of our protocol. Findings show preliminary evidence that CDS improves the efficiency and effectiveness of care planning decisions and that the optimal format may depend on individual RN characteristics. We recommend a study with sufficient power to compare different CDS formats and assess the impact of potential covariates on adoption rates and care planning time.

  17. Preventing Loss of Independence through Exercise (PLIÉ): A Pilot Clinical Trial in Older Adults with Dementia

    PubMed Central

    Barnes, Deborah E.; Mehling, Wolf; Wu, Eveline; Beristianos, Matthew; Yaffe, Kristine; Skultety, Karyn; Chesney, Margaret A.

    2015-01-01

    Background Current dementia medications have small effect sizes, many adverse effects and do not change the disease course. Therefore, it is critically important to study alternative treatment strategies. The goal of this study was to pilot-test a novel, integrative group exercise program for individuals with mild-to-moderate dementia called Preventing Loss of Independence through Exercise (PLIÉ), which focuses on training procedural memory for basic functional movements (e.g., sit-to-stand) while increasing mindful body awareness and facilitating social connection. Methods We performed a 36-week cross-over pilot clinical trial to compare PLIÉ with usual care (UC) at an adult day program for individuals with dementia in San Francisco, CA. Assessments of physical performance, cognitive function, physical function, dementia-related behaviors, quality of life and caregiver burden were performed by blinded assessors at baseline, 18 weeks (cross-over) and 36 weeks. Our primary outcomes were effect sizes based on between-group comparisons of change from baseline to 18 weeks; secondary outcomes were within-group comparisons of change before and after cross-over. Results Twelve individuals enrolled (7 PLIÉ, 5 UC) and 2 withdrew (1 PLIÉ, 18 weeks; 1 UC, 36 weeks). Participants were 82% women (mean age, 84 ± 4 years); caregivers were 82% daughters (mean age, 56 ± 13 years). Effect sizes were not statistically significant but suggested potentially clinically meaningful (≥0.25 SDs) improvement with PLIÉ versus UC for physical performance (Cohen’s D: 0.34 SDs), cognitive function (0.76 SDs) and quality of life (0.83 SDs) as well as for caregiver measures of participant’s quality of life (0.33 SDs) and caregiver burden (0.49 SDs). Results were similar when within-group comparisons were made before and after cross-over. Conclusions PLIÉ is a novel, integrative exercise program that shows promise for improving physical function, cognitive function, quality of life

  18. Characterization of Cystic Lesions by Spectral Mammography: Results of a Clinical Pilot Study.

    PubMed

    Erhard, Klaus; Kilburn-Toppin, Fleur; Willsher, Paula; Moa, Elin; Fredenberg, Erik; Wieberneit, Nataly; Buelow, Thomas; Wallis, Matthew G

    2016-05-01

    Round lesions are a common mammographic finding, which can contribute more than 20% of overall recalls at screening. Discrimination of cystic fluid from solid tissue by spectral x-ray imaging has been demonstrated in specimen experiments. This work translates these results into a clinical pilot study to investigate the feasibility of discriminating cystic from solid lesions using spectral mammography. Women undergoing mammography as part of their routine diagnostic workup were consented for analysis of spectral information obtained from a photon-counting mammography system. Images were analyzed retrospectively after diagnosis was confirmed with ultrasound and pathology. Well-defined solitary lesions were delineated independently by 3 expert radiologists. A breast lesion model is generated from the spectral mammography data using the energy-dependent x-ray attenuation of cyst fluid, carcinoma, and adipose and glandular tissue. From the breast lesion model, 2 spectral features are computed and combined in a 2-feature discrimination algorithm, which is evaluated in an analysis of the receiver operating characteristic curve for the task of identifying solid lesions ("positive result"). Expected outcomes on a screening population are extrapolated from this pilot study by cross-validation with bootstrapping using a 95% confidence interval (CI). The 2-feature discrimination algorithm was evaluated on the set of 119 eligible lesions (62 solids, 57 cysts) of diameter greater than 10 mm. The area under the receiver operating characteristic curve (AUC) was 0.88 with a specificity of 61% at the 99% sensitivity level on average over all expert radiologists. Cross-validation with bootstrapping of the clinical data revealed an AUC of 0.89 (95% CI, 0.79-0.96) and a specificity of 56% (95% CI, 33%-78%) when operating the algorithm at the 99% sensitivity level. Discriminating cystic from solid lesions with spectral mammography demonstrates promising results with the potential to

  19. Clinical use of cold atmospheric pressure argon plasma in chronic leg ulcers: A pilot study.

    PubMed

    Ulrich, C; Kluschke, F; Patzelt, A; Vandersee, S; Czaika, V A; Richter, H; Bob, A; Hutten, J von; Painsi, C; Hüge, R; Kramer, A; Assadian, O; Lademann, J; Lange-Asschenfeldt, B

    2015-05-01

    In the age of multiresistant microbes and the increasing lack of efficient antibiotics, conventional antiseptics play a critical role in the prevention and therapy of wound infections. Recent studies have demonstrated the antiseptic effects of cold atmospheric pressure plasma (APP). In this pilot, study we investigate the overall suitability of one of the first APP sources for wound treatment focusing on its potential antimicrobial effects. The wound closure rate and the bacterial colonisation of the wounds were investigated. Patients suffering from chronic leg ulcers were treated in a clinical controlled monocentric trial with either APP or octenidine (OCT). In patients who presented with more than one ulceration in different locations, one was treated with APP and the other one with OCT. Each group was treated three times a week over a period of two weeks. The antimicrobial efficacy was evaluated immediately after and following two weeks of treatment. Wounds treated with OCT showed a significantly higher microbial reduction (64%) compared to wounds treated with APP (47%) immediately after the treatment. Over two weeks of antiseptic treatment the bacterial density was reduced within the OCT group (-35%) compared to a slight increase in bacterial density in the APP-treated group (+12%). Clinically, there were no signs of delayed wound healing observed in either group and both treatments were well tolerated. The immediate antimicrobial effects of the APP prototype source were almost comparable to OCT without any signs of cytotoxicity. This pilot study is limited by current configurations of the plasma source, where the narrow plasma beam made it difficult to cover larger wound surface areas and in order to avoid untreated areas of the wound bed, smaller wounds were assigned to the APP-treatment group. This limits the significance of AAP-related effects on the wound healing dynamics, as smaller wounds tend to heal faster than larger wounds. However, clinical wound

  20. Adaptive prediction model in prospective molecular-signature-based clinical studies

    PubMed Central

    Xiao, Guanghua; Ma, Shuangge; Minna, John; Xie, Yang

    2014-01-01

    Use of molecular profiles and clinical information can help predict which treatment would give the best outcome and survival for each individual patient, and thus guide optimal therapy, which offers great promise for the future of clinical trials and practice. High prediction accuracy is essential for selecting the best treatment plan. The gold standard for evaluating the prediction models is prospective clinical studies, where patients are enrolled sequentially. However, there is no statistical method utilizing this sequential feature to adapt the prediction model to the current patient cohort. In this paper, we proposed a re-weighted random forest (RWRF) model, which updates the weight of each decision tree whenever additional patient information is available, in order to account for the potential heterogeneity between training and testing data. A simulation study and a lung cancer example were used to show that the proposed method can adapt the prediction model to current patients’ characteristics, and therefore improve prediction accuracy significantly. We also showed that the proposed method can identify important and consistent predictive variables. Compared to rebuilding the prediction model, the RWRF updates a well-tested model gradually, and all of the adaptive procedure/parameters used in the RWRF model are pre-specified before patient recruitment, which are important practical advantages for prospective clinical studies. PMID:24323903

  1. Adaptive prediction model in prospective molecular signature-based clinical studies.

    PubMed

    Xiao, Guanghua; Ma, Shuangge; Minna, John; Xie, Yang

    2014-02-01

    Use of molecular profiles and clinical information can help predict which treatment would give the best outcome and survival for each individual patient, and thus guide optimal therapy, which offers great promise for the future of clinical trials and practice. High prediction accuracy is essential for selecting the best treatment plan. The gold standard for evaluating the prediction models is prospective clinical studies, in which patients are enrolled sequentially. However, there is no statistical method using this sequential feature to adapt the prediction model to the current patient cohort. In this article, we propose a reweighted random forest (RWRF) model, which updates the weight of each decision tree whenever additional patient information is available, to account for the potential heterogeneity between training and testing data. A simulation study and a lung cancer example are used to show that the proposed method can adapt the prediction model to current patients' characteristics, and, therefore, can improve prediction accuracy significantly. We also show that the proposed method can identify important and consistent predictive variables. Compared with rebuilding the prediction model, the RWRF updates a well-tested model gradually, and all of the adaptive procedure/parameters used in the RWRF model are prespecified before patient recruitment, which are important practical advantages for prospective clinical studies. ©2013 AACR.

  2. Development of a clinical decision support system for diabetes care: A pilot study.

    PubMed

    Sim, Livvi Li Wei; Ban, Kenneth Hon Kim; Tan, Tin Wee; Sethi, Sunil Kumar; Loh, Tze Ping

    2017-01-01

    Management of complex chronic diseases such as diabetes requires the assimilation and interpretation of multiple laboratory test results. Traditional electronic health records tend to display laboratory results in a piecemeal and segregated fashion. This makes the assembly and interpretation of results related to diabetes care challenging. We developed a diabetes-specific clinical decision support system (Diabetes Dashboard) interface for displaying glycemic, lipid and renal function results, in an integrated form with decision support capabilities, based on local clinical practice guidelines. The clinical decision support system included a dashboard feature that graphically summarized all relevant laboratory results and displayed them in a color-coded system that allowed quick interpretation of the metabolic control of the patients. An alert module informs the user of tests that are due for repeat testing. An interactive graph module was also developed for better visual appreciation of the trends of the laboratory results of the patient. In a pilot study involving case scenarios administered via an electronic questionnaire, the Diabetes Dashboard, compared to the existing laboratory reporting interface, significantly improved the identification of abnormal laboratory results, of the long-term trend of the laboratory tests and of tests due for repeat testing. However, the Diabetes Dashboard did not significantly improve the identification of patients requiring treatment adjustment or the amount of time spent on each case scenario. In conclusion, we have developed and shown that the use of the Diabetes Dashboard, which incorporates several decision support features, can improve the management of diabetes. It is anticipated that this dashboard will be most helpful when deployed in an outpatient setting, where physicians can quickly make clinical decisions based on summarized information and be alerted to pertinent areas of care that require additional attention.

  3. Development of a clinical decision support system for diabetes care: A pilot study

    PubMed Central

    Sim, Livvi Li Wei; Ban, Kenneth Hon Kim; Tan, Tin Wee; Sethi, Sunil Kumar; Loh, Tze Ping

    2017-01-01

    Management of complex chronic diseases such as diabetes requires the assimilation and interpretation of multiple laboratory test results. Traditional electronic health records tend to display laboratory results in a piecemeal and segregated fashion. This makes the assembly and interpretation of results related to diabetes care challenging. We developed a diabetes-specific clinical decision support system (Diabetes Dashboard) interface for displaying glycemic, lipid and renal function results, in an integrated form with decision support capabilities, based on local clinical practice guidelines. The clinical decision support system included a dashboard feature that graphically summarized all relevant laboratory results and displayed them in a color-coded system that allowed quick interpretation of the metabolic control of the patients. An alert module informs the user of tests that are due for repeat testing. An interactive graph module was also developed for better visual appreciation of the trends of the laboratory results of the patient. In a pilot study involving case scenarios administered via an electronic questionnaire, the Diabetes Dashboard, compared to the existing laboratory reporting interface, significantly improved the identification of abnormal laboratory results, of the long-term trend of the laboratory tests and of tests due for repeat testing. However, the Diabetes Dashboard did not significantly improve the identification of patients requiring treatment adjustment or the amount of time spent on each case scenario. In conclusion, we have developed and shown that the use of the Diabetes Dashboard, which incorporates several decision support features, can improve the management of diabetes. It is anticipated that this dashboard will be most helpful when deployed in an outpatient setting, where physicians can quickly make clinical decisions based on summarized information and be alerted to pertinent areas of care that require additional attention. PMID

  4. A pilot study to develop an objective clinical score for canine otitis externa.

    PubMed

    Nuttall, Tim; Bensignor, Emmanuel

    2014-12-01

    The lack of an accepted clinical scoring system in canine otitis externa makes it difficult to compare clinical trials. To develop a score that is clinically relevant, reliable and sensitive to change. Client-owned healthy dogs (n = 55) and dogs with otitis externa (n = 60). We compared 0-3 and 0-5 assessments of erythema, oedema/swelling, erosion/ulceration, exudate and pain of the ear canals with a reference 0-2 scale. Additional data included odour, pruritus scores, tympanic membrane condition, treatment outcome and neutrophil, bacterial and Malassezia counts. There were no significant differences between the vertical and horizontal canal scores (correlation coefficients >0.93). Correlation coefficients for the 0-3 and 0-5 scales were also >0.9 for all parameters, but the 0-2 scale was more variable. Pain and pruritus did not correlate well with the lesion scores and were associated with suppurative and erythroceruminous otitis, respectively. Neutrophil and microbial counts were variable and could not be used to generate cut-off values to differentiate healthy and affected ears or determine the response to therapy. Total scores ≥4 differentiated affected from healthy ears with 91.1% sensitivity and 100% specificity; scores ≤3 were 100% sensitive and 91.9% specific for clinical success. The intra- and interobserver reliability was high (intraclass correlation coefficients >0.95 and Cohen's kappa coefficients >0.65). This pilot study showed that the 0-3 Otitis Index Score (OTIS3) for erythema, oedema/swelling, erosion/ulceration and exudate is suitable for further validation by a larger group of clinicians. © 2014 ESVD and ACVD.

  5. Italian multicentre study on microbial environmental contamination in dental clinics: a pilot study.

    PubMed

    Pasquarella, Cesira; Veronesi, Licia; Castiglia, Paolo; Liguori, Giorgio; Montagna, Maria Teresa; Napoli, Christian; Rizzetto, Rolando; Torre, Ida; Masia, Maria Dolores; Di Onofrio, Valeria; Colucci, Maria Eugenia; Tinteri, Carola; Tanzi, Marialuisa

    2010-09-01

    The dental practice is associated with a high risk of infections, both for patients and healthcare operators, and the environment may play an important role in the transmission of infectious diseases. A microbiological environmental investigation was carried out in six dental clinics as a pilot study for a larger multicentre study that will be performed by the Italian SItI (Society of Hygiene, Preventive Medicine and Public Health) working group "Hygiene in Dentistry". Microbial contamination of water, air and surfaces was assessed in each clinic during the five working days of the week, before and during treatments. Air and surfaces were also examined at the end of the daily activity. A wide variation was found in microbial environmental contamination, both within the participating clinics and relative to the different sampling times. Microbial water contamination in Dental Unit Water Systems (DUWS) reached values of up to 26x10(4)cfu/mL (colony forming units per millilitre). P. aeruginosa was found in 33% of the sampled DUWS and Legionella spp. in 50%. A significant decrease in the Total Viable Count (TVC) was recorded during the activity. Microbial air contamination showed the highest levels during dental treatments and tended to decrease at the end of the working activity (p<0.05). Microbial buildup on surfaces increased significantly during the working hours. As these findings point out, research on microbial environmental contamination and the related risk factors in dental clinics should be expanded and should also be based on larger collections of data, in order to provide the essential knowledge aimed at targeted preventive interventions.

  6. Photogrammetry--an alternative to conventional impressions in implant dentistry? A clinical pilot study.

    PubMed

    Jemt, T; Bäck, T; Petersson, A

    1999-01-01

    The purpose of this clinical pilot study was to describe a photogrammetric technique to determine implant positions in the oral cavity, and to test and compare this technique to conventional impression/master cast procedures for fabrication of titanium frameworks with a computer numeric-controlled (CNC) milling technique. Implant positions were recorded by means of conventional impressions/master casts as well as intraoral 3-dimensional photogrammetric measurements in 2 patients who were provided with 5 Brånemark implants each in the edentulous mandible. For each patient 2 titanium frameworks were made by means of a CNC milling technique (All-in-One). Both frameworks had an identical design, but the orientations of the framework cylinder fit surfaces were machined either from measurements from the master casts or from the intraoral photogrammetric measurements. The frameworks were tried for fit in the oral cavity and on the master casts. Both cases showed different precision of fit when comparing the 2 frameworks on the master casts. One of the 2 photogrammetric frameworks was not considered acceptable when tried on the models. In the oral cavity, however, all 4 frameworks presented comparable fit, and all were accepted for clinical use. The clinical experiences with try-in of the 4 different frameworks indicated that the photogrammetric technique could be a valid option for conventional impressions when using CNC milling fabrication in implant dentistry. The different results from the model and oral examinations also imply the difficulties of assessing clinical fit when testing fit at the master cast level only.

  7. Feasibility of a Sexual Health Clinic Within Cancer Care: A Pilot Study Using Qualitative Methods.

    PubMed

    Tracy, Myrna; McDivitt, Karmen; Ryan, Maureen; Tomlinson, Jamie; Brotto, Lori A

    2016-01-01

    As cancer survival rates increase, so does the imperative for a satisfying quality of life, including a fulfilling sexual life. The feasibility and effectiveness of a newly formed Sexual Health Clinic were determined using a nurse-led format, which provided support to survivors in a cancer care setting. Twenty-one cancer survivors received assessment, education, and tailored sexual health support by an oncology nurse with specialized skills in sexual health. Two months later, semistructured interviews focused on patients' personal experiences. Questionnaires were also administered to healthcare providers involved in providing the follow-up care. Participants presented with sexual concerns that were psychological, physical, and/or relational. Scores on validated measures of sexual functioning were in the range comparable to those with a sexual dysfunction. Participants were open to being asked about sexual health and wanted professionals available who were skilled in dealing with sexual health services. Most participants experienced an improvement in their well-being and/or sexual life following participation. Some noted more confidence when speaking with their partner about sexual concerns. Our pilot Sexual Health Clinic was feasible, and evidence for its effectiveness was based on qualitative feedback. Participants and providers identified a strong need for the inclusion of sexual health services in cancer care. Oncology nurses are in a key position to initiate discussions surrounding sexual health issues related to cancer treatment. Self-awareness, sensitivity, and a nonjudgmental approach are required to address this dimension of holistic cancer care.

  8. [Prospective study of 221 community acquired pneumonias followed up in an outpatient clinic. Etiology and clinical-radiological progression].

    PubMed

    Javier Alvarez Gutiérrez, F; del Castillo Otero, D; García Fernández, A; Romero Romero, B; José del Rey Pérez, J; Soto Campos, G; Castillo Gómez, J

    2001-02-10

    All the community acquired pneumonia followed up in an outpatient clinic were prospectively studied in order to determine: etiology, clinical-radiological characteristics and its progression with diagnostic and therapeutic protocols. We arranged clinical evaluation protocols, etiological diagnosis by means of serology (in the first visit and three weeks later); and when necessary, by means of fiberbronchoscopy (protected microbiological brush), as well as clinical and radiological progression (up to three visits) after empirical treatment. Initially, 240 patients were included, of which 221 were fully followed up. Etiological diagnosis was obtained in 86 patients (39%). The bacteria most frequently isolated was Coxiella burnetii (12.2%), followed up Mycoplasma pneumoniae and Legionella pneumophila. Two cases of Strepcococus pneumoniae were diagnosed. The most frequent radiological onset was alveolar infiltrate (86%). The initial empiric treatment were macrolids (71%) or second generation cephalosporines (22%). Most patients presented a favourable clinical and radiological progression. Only 2 patients needed admission to the hospital (< 1%). In community acquired pneumonias studied in our outpatient clinic we found a high number of "atypical" agents. Treatment with macrolids or second generation cephalosporines are appropriate for these patients.

  9. Maternal Stress and Young Children's Behavioural Development: A Prospective Pilot Study from 8 to 36 Months in a Finnish Sample

    ERIC Educational Resources Information Center

    Haapsamo, Helena; Pollock-Wurman, Rachel A.; Kuusikko-Gauffin, Sanna; Ebeling, Hanna; Larinen, Katja; Soini, Hannu; Moilanen, Irma

    2013-01-01

    The relationship between maternal parenting stress and infant/toddler behavioural development was examined in a longitudinal pilot study. Fifty mothers reported parenting stress via the Parenting Stress Index-Short Form when their infants were eight months old. Parents subsequently rated their children's emotional and behavioural problems with the…

  10. Maternal Stress and Young Children's Behavioural Development: A Prospective Pilot Study from 8 to 36 Months in a Finnish Sample

    ERIC Educational Resources Information Center

    Haapsamo, Helena; Pollock-Wurman, Rachel A.; Kuusikko-Gauffin, Sanna; Ebeling, Hanna; Larinen, Katja; Soini, Hannu; Moilanen, Irma

    2013-01-01

    The relationship between maternal parenting stress and infant/toddler behavioural development was examined in a longitudinal pilot study. Fifty mothers reported parenting stress via the Parenting Stress Index-Short Form when their infants were eight months old. Parents subsequently rated their children's emotional and behavioural problems with the…

  11. Success rates with nicotine personal vaporizers: a prospective 6-month pilot study of smokers not intending to quit.

    PubMed

    Polosa, Riccardo; Caponnetto, Pasquale; Maglia, Marilena; Morjaria, Jaymin B; Russo, Cristina

    2014-11-08

    Electronic cigarettes (e-Cigs) are an attractive long-term alternative nicotine source to conventional cigarettes. Although they may assist smokers to remain abstinent during their quit attempt, studies using first generation e-Cigs report low success rates. Second generation devices (personal vaporisers - PVs) may result in much higher quit rates, but their efficacy and safety in smoking cessation and/or reduction in clinical trials is unreported. We conducted a prospective proof-of-concept study monitoring modifications in smoking behaviour of 50 smokers (unwilling to quit) switched onto PVs. Participants attended five study visits: baseline, week-4, week-8, week-12 and week-24. Number of cigarettes/day (cigs/day) and exhaled carbon monoxide (eCO) levels were noted at each visit. Smoking reduction/abstinence rates, product usage, adverse events and subjective opinions of these products were also reviewed. Sustained 50% and 80% reduction in cigs/day at week-24 was reported in 15/50 (30%) and 7/50 (14%) participants with a reduction from 25cigs/day to 6cigs/day (p < 0.001) and 3cigs/day (p < 0.001), respectively. Smoking abstinence (self-reported abstinence from cigarette smoking verified by an eCO ≤10 ppm) at week-24 was observed in 18/50 (36%) participants, with 15/18 (83.3%) still using their PVs at the end of the study. Combined 50% reduction and smoking abstinence was shown in 33/50 (66%) participants. Throat/mouth irritation (35.6%), dry throat/mouth (28.9%), headache (26.7%) and dry cough (22.2%) were frequently reported early in the study, but waned substantially by week-24. Participants' perception and acceptance of the products was very good. The use of second generation PVs substantially decreased cigarette consumption without causing significant adverse effects in smokers not intending to quit. (ClinicalTrials.gov Identifier: NCT02124200).

  12. How common is adenomyosis? A prospective study of prevalence using transvaginal ultrasound in a gynaecology clinic.

    PubMed

    Naftalin, J; Hoo, W; Pateman, K; Mavrelos, D; Holland, T; Jurkovic, D

    2012-12-01

    What is the prevalence of adenomyosis in a population of women attending a general gynaecological clinic? Adenomyosis was present in 206 of 985 [20.9%; 95% confidence interval (CI): 18.5-23.6%] women included in the study. Previous studies of occurrence of adenomyosis have been limited to women who underwent hysterectomy, which is likely to overestimate its prevalence compared with the general population of women. There are no large prospective studies on the prevalence of adenomyosis, either in the general population of women or in a general gynaecology clinic setting. This was a prospective observational study set in the general gynaecology clinic of a university teaching hospital between January 2009 and January 2010. There were 985 consecutive women who attended the clinic and underwent structured clinical and transvaginal ultrasound examination in accordance with the study protocol. Morphological features of adenomyosis were systematically recorded with the ultrasound scan to determine its prevalence and factors which may affect its occurrence. Adenomyosis was present in 206/985 [20.9% (95% CI: 18.5-23.6%)] women included in the study. Multivariate analysis showed that the prevalence of adenomyosis was significantly associated with women's age, gravidity and pelvic endometriosis (P< 0.001). In women who subsequently underwent hysterectomy, there was a good level of agreement between the ultrasound and histological diagnosis of adenomyosis [κ = 0.62 (P = 0.001), 95% CI (0.324, 0.912)]. Our estimate of prevalence of adenomyosis is likely to be higher than in the general population as we studied symptomatic women attending a gynaecology clinic. Better estimates of the prevalence of adenomyosis can improve our understanding of the burden of the disease, help to identify women at high risk of developing the condition and facilitate the development of preventative strategies and effective treatment. The authors have no competing interests to declare. The study was

  13. Influence of Climate on Clinical Diagnostic Dry Eye Tests: Pilot Study.

    PubMed

    Tesón, Marisa; López-Miguel, Alberto; Neves, Helena; Calonge, Margarita; González-García, María J; González-Méijome, José M

    2015-09-01

    To analyze dry eye disease (DED) tests and their consistency in similar nonsymptomatic population samples living in two geographic locations with different climates (Continental vs. Atlantic). This is a pilot study including 14 nonsymptomatic residents from Valladolid (Continental climate, Spain) and 14 sex-matched and similarly aged residents from Braga (Atlantic climate, Portugal); they were assessed during the same season (spring) of two consecutive years. Phenol red thread test, conjunctival hyperemia, fluorescein tear breakup time, corneal and conjunctival staining, and Schirmer test were evaluated on three different consecutive visits. Reliability was assessed using the intraclass correlation coefficient and weighted kappa (κ) coefficient for quantitative and ordinal variables, respectively. Fourteen subjects were recruited in each city with a mean (± SD) age of 63.0 (± 1.7) and 59.1 (± 0.9) years (p = 0.08) in Valladolid and Braga, respectively. Intraclass correlation coefficient and κ values of the tests performed were below 0.69 and 0.61, respectively, for both samples, thus showing moderate to poor reliability. Subsequently, comparisons were made between the results corresponding to the middle and higher outdoor relative humidity (RH) visit in each location as there were no differences in mean temperature (p ≥ 0.75) despite RH values significantly differing (p ≤ 0.005). Significant (p ≤ 0.05) differences were observed between Valladolid and Braga samples on tear breakup time (middle RH visit, 2.76 ± 0.60 vs. 5.26 ± 0.64 seconds; higher RH visit, 2.61 ± 0.32 vs. 5.78 ± 0.88 seconds) and corneal (middle RH, 0.64 ± 0.17 vs. 0.14 ± 0.10; higher RH, 0.60 ± 0.22 vs. 0.0 ± 0.0) and conjunctival staining (middle RH, 0.61 ± 0.17 vs. 0.14 ± 0.08; higher RH, 0.57 ± 0.15 vs. 0.18 ± 0.09). This pilot study provides initial evidence to support that DED test outcomes assessing the ocular surface integrity and tear stability are climate dependent

  14. Using clinical simulation centers to test design interventions: a pilot study of lighting and color modifications.

    PubMed

    Gray, Whitney Austin; Kesten, Karen S; Hurst, Stephen; Day, Tama Duffy; Anderko, Laura

    2012-01-01

    The aim of this pilot study was to test design interventions such as lighting, color, and spatial color patterning on nurses' stress, alertness, and satisfaction, and to provide an example of how clinical simulation centers can be used to conduct research. The application of evidence-based design research in healthcare settings requires a transdisciplinary approach. Integrating approaches from multiple fields in real-life settings often proves time consuming and experimentally difficult. However, forums for collaboration such as clinical simulation centers may offer a solution. In these settings, identical operating and patient rooms are used to deliver simulated patient care scenarios using automated mannequins. Two identical rooms were modified in the clinical simulation center. Nurses spent 30 minutes in each room performing simulated cardiac resuscitation. Subjective measures of nurses' stress, alertness, and satisfaction were collected and compared between settings and across time using matched-pair t-test analysis. Nurses reported feeling less stressed after exposure to the experimental room than nurses who were exposed to the control room (2.22, p = .03). Scores post-session indicated a significant reduction in stress and an increase in alertness after exposure to the experimental room as compared to the control room, with significance levels below .10. (Change in stress scores: 3.44, p = .069); (change in alertness scores: 3.6, p = .071). This study reinforces the use of validated survey tools to measure stress, alertness, and satisfaction. Results support human-centered design approaches by evaluating the effect on nurses in an experimental setting.

  15. Mid-infrared laser orbital septal tightening: ex vivo dosimetry study and pilot clinical study.

    PubMed

    Chu, Eugene A; Li, Michael; Lazarow, Frances B; Wong, Brian J F

    2014-01-01

    Blepharoplasty is one of the most commonly performed facial aesthetic surgeries. While myriad techniques exist to improve the appearance of the lower eyelids, there is no clear consensus on the optimal management of the orbital septum. To evaluate the safety and feasibility of the use of the holmium:yttrium aluminum garnet (Ho:YAG) laser for orbital septal tightening, and to determine whether modest use of this laser would provide some degree of clinical efficacy. Direct laser irradiation of ex vivo bovine tissue was used to determine appropriate laser dosimetry using infrared thermal imaging and optical coherence tomography before conducting a pilot clinical study in 5 patients. Laser irradiation of the lower eyelid orbital septum was performed through a transconjunctival approach. Standardized preoperative and postoperative photographs were taken for each patient and evaluated by 6 unbiased aesthetic surgeons. Use of the Ho:YAG laser for orbital septal tightening. To determine appropriate laser dosimetry, infrared thermal imaging and optical coherence tomography were used to monitor temperature and tissue shape changes of ex vivo bovine tissue that was subjected to direct laser irradiation. For the clinical study, preoperative and postoperative photographs were evaluated by 6 surgeons on a 10-point Likert scale. Optical coherence tomography demonstrated that laser irradiation of bovine tissue to a temperature range of 60°C to 80°C resulted in an increase in thickness of up to 2-fold. There were no complications or adverse cosmetic outcomes in the patient study. Patient satisfaction with the results of surgery averaged 7 on a 10-point Likert scale. For 3 patients, 3 (50%) of the evaluators believed there was a mild improvement in appearance of the lower eyelids after surgery. The remaining patients were thought to have no significant changes. Transconjunctival Ho:YAG laser blepharoplasty is a safe procedure that may ameliorate mild pseudoherniation of lower

  16. Modeling progression risk for smoldering multiple myeloma: results from a prospective clinical study.

    PubMed

    Cherry, Benjamin M; Korde, Neha; Kwok, Mary; Manasanch, Elisabet E; Bhutani, Manisha; Mulquin, Marcia; Zuchlinski, Diamond; Yancey, Mary Ann; Maric, Irina; Calvo, Katherine R; Braylan, Raul; Stetler-Stevenson, Maryalice; Yuan, Constance; Tembhare, Prashant; Zingone, Adriana; Costello, Rene; Roschewski, Mark J; Landgren, Ola

    2013-10-01

    The risk of progression to multiple myeloma (MM) from the precursor condition smoldering MM (SMM) varies considerably among individual patients. Reliable markers for progression to MM are vital to advance the understanding of myeloma precursor disease and for the development of intervention trials designed to delay/prevent MM. The Mayo Clinic and Spanish PETHEMA have proposed models to stratify patient risk based on clinical parameters. The aim of our study was to define the degree of concordance between these two models by comparing the distribution of patients with SMM classified as low, medium and high risk for progression. A total of 77 patients with SMM were enrolled in our prospective natural history study. Per study protocol, each patient was assigned risk scores based on both the Mayo and the Spanish models. The Mayo Clinic model identified 38, 35 and four patients as low, medium and high risk, respectively. The Spanish PETHEMA model classified 17, 22 and 38 patients as low, medium and high risk, respectively. There was significant discordance in overall patient risk classification (28.6% concordance) and in classifying patients as low versus high (p < 0.0001), low versus non-low (p = 0.0007) and high versus non-high (p < 0.0001) risk. There is a need for prospectively validated models to characterize individual patient risk of transformation to MM.

  17. Prospective, Multicentre, Nationwide Clinical Data from 600 Cases of Acute Pancreatitis

    PubMed Central

    Párniczky, Andrea; Kui, Balázs; Szentesi, Andrea; Balázs, Anita; Szűcs, Ákos; Mosztbacher, Dóra; Czimmer, József; Sarlós, Patrícia; Bajor, Judit; Gódi, Szilárd; Vincze, Áron; Illés, Anita; Szabó, Imre; Pár, Gabriella; Takács, Tamás; Czakó, László; Szepes, Zoltán; Rakonczay, Zoltán; Izbéki, Ferenc; Gervain, Judit; Halász, Adrienn; Novák, János; Crai, Stefan; Hritz, István; Góg, Csaba; Sümegi, János; Golovics, Petra; Varga, Márta; Bod, Barnabás; Hamvas, József; Varga-Müller, Mónika; Papp, Zsuzsanna; Sahin-Tóth, Miklós; Hegyi, Péter

    2016-01-01

    Objective The aim of this study was to analyse the clinical characteristics of acute pancreatitis (AP) in a prospectively collected, large, multicentre cohort and to validate the major recommendations in the IAP/APA evidence-based guidelines for the management of AP. Design Eighty-six different clinical parameters were collected using an electronic clinical research form designed by the Hungarian Pancreatic Study Group. Patients 600 adult patients diagnosed with AP were prospectively enrolled from 17 Hungarian centres over a two-year period from 1 January 2013. Main Results With respect to aetiology, biliary and alcoholic pancreatitis represented the two most common forms of AP. The prevalence of biliary AP was higher in women, whereas alcoholic AP was more common in men. Hyperlipidaemia was a risk factor for severity, lack of serum enzyme elevation posed a risk for severe AP, and lack of abdominal pain at admission demonstrated a risk for mortality. Abdominal tenderness developed in all the patients with severe AP, while lack of abdominal tenderness was a favourable sign for mortality. Importantly, lung injury at admission was associated with mortality. With regard to laboratory parameters, white blood cell count and CRP were the two most sensitive indicators for severe AP. The most common local complication was peripancreatic fluid, whereas the most common distant organ failure in severe AP was lung injury. Deviation from the recommendations in the IAP/APA evidence-based guidelines on fluid replacement, enteral nutrition and timing of interventions increased severity and mortality. Conclusions Analysis of a large, nationwide, prospective cohort of AP cases allowed for the identification of important determinants of severity and mortality. Evidence-based guidelines should be observed rigorously to improve outcomes in AP. PMID:27798670

  18. Clinical outcomes of extracorporeal shock wave therapy in patients with secondary lymphedema: a pilot study.

    PubMed

    Bae, Hasuk; Kim, Ho Jeong

    2013-04-01

    To investigate the clinical effect of extracorporeal shock wave therapy (ESWT) in patients with secondary lymphedema after breast cancer treatment. In a prospective clinical trial, ESWT was performed consecutively 4 times over two weeks in 7 patients who were diagnosed with stage 3 secondary lymphedema after breast cancer treatment. Each patient was treated with four sessions of ESWT (0.056-0.068 mJ/mm(2), 2,000 impulses). The parameters were the circumference of the arm, thickness of the skin and volume of the arm. We measured these parameters with baseline values before ESWT and repeated the evaluation after each ESWT treatment. Subjective data on skin thickness, edema and sensory impairment were obtained using a visual analogue scale (VAS). The mean volume of the affected arm after four consecutive ESWT was significantly reduced from 2,332 to 2,144 mL (p<0.05). The circumference and thickness of the skin fold of the affected arm were significantly decreased after the fourth ESWT (p<0.05). The three VAS scores were significantly improved after the fourth ESWT. Almost all patients were satisfied with this treatment and felt softer texture in their affected arm after treatment. ESWT is an effective modality in the treatment of stage 3 lymphedema after breast cancer treatment. ESWT reduced the circumference and the thickness of arms with lymphedema and satisfied almost all patients with lymphedema. Therefore, this treatment provides clinically favorable outcome to patients with breast cancer-related lymphedema.

  19. Prospective roles for Canadian oncology nurses in breast cancer rapid diagnostic clinics.

    PubMed

    Zanchetta, M S; Maheu, C; Baku, L; Wedderburn, P J S; Lemonde, M

    2015-01-01

    The introduction of rapid diagnostic clinics for breast cancer increases oncology nurses' (ONs) responsibility for patient education and coordination of multidisciplinary care. Developed as an outcome of the E-Mentorship Oncology Nursing Program, this paper proposes new roles for these nurses to respond effectively and competently to such diagnostic innovation. The Oslo Manual Conceptual Framework of Innovation inspired the idea of change in prospective ONs' roles, corroborated by the Canadian Association of Nurses in Oncology's Standards of Practice and Competencies. New roles for ONs that are informed by the domain of information dynamics and evidence-based care are proposed.

  20. Drug-related problems in geriatric rehabilitation patients after discharge - A prevalence analysis and clinical case scenario-based pilot study.

    PubMed

    Freyer, Johanna; Hueter, Lucie; Kasprick, Lysann; Frese, Thomas; Sultzer, Ralf; Schiek, Susanne; Bertsche, Thilo

    2017-07-25

    Geriatric patients bear a high risk for having drug-related problems (DRPs). Transitions of care are especially susceptible to these DRPs. To highlight the prevalence of DRPs in geriatric patients' post-discharge medication lists and to assess physicians' ability to identify DRPs by using clinical case scenarios. A sequential prospective mixed-method study was performed. In a DRP prevalence analysis, an expert panel of clinical pharmacists analyzed DRPs in post-discharge medication lists of long-term hospitalized patients from a German inpatient geriatric rehabilitation center. Based on these results, the expert panel created two clinical case scenarios with applicable medication history. The cases were reflective of the most commonly identified DRPs. They were provided to hospital physicians and general practitioners (GPs) for assessment. Physicians were asked whether they approve the prescriptions in the clinical case scenarios. If a physician had not identified a prescription containing a defined DRP, the clinical pharmacist then provided drug information about it. With this, physicians' ability to identify DRPs and their response to a theoretical intervention was assessed. DRP prevalence analysis: A total of 639 prescriptions were analyzed from 63 enrolled patients of whom 52 (83%) were affected by at least one DRP. Twenty-eight hospital physicians and 26 GPs have been assessed. They identified 172 (46%) from 378 possible DRPs (seven DRPs multiplied by 54 physicians). For unidentified DRPs, physicians received tailored drug information and the number of identified DRPs rose to 298 (79%). A clear majority of patients were affected by DRPs. However, the results from the following pilot study confirm that many DRPs at care transitions can be reduced by providing applicable medication history and drug information. This intervention can be done by clinical pharmacists as part of the multidisciplinary care team in routine care. Geriatric patients bear a high risk

  1. “Cancer 2015”: A Prospective, Population-Based Cancer Cohort—Phase 1: Feasibility of Genomics-Guided Precision Medicine in the Clinic

    PubMed Central

    Parisot, John P.; Thorne, Heather; Fellowes, Andrew; Doig, Ken; Lucas, Mark; McNeil, John J.; Doble, Brett; Dobrovic, Alexander; John, Thomas; James, Paul A.; Lipton, Lara; Ashley, David; Hayes, Theresa; McMurrick, Paul; Richardson, Gary; Lorgelly, Paula; Fox, Stephen B.; Thomas, David M.

    2015-01-01

    “Cancer 2015” is a longitudinal and prospective cohort. It is a phased study whose aim was to pilot recruiting 1000 patients during phase 1 to establish the feasibility of providing a population-based genomics cohort. Newly diagnosed adult patients with solid cancers, with residual tumour material for molecular genomics testing, were recruited into the cohort for the collection of a dataset containing clinical, molecular pathology, health resource use and outcomes data. 1685 patients have been recruited over almost 3 years from five hospitals. Thirty-two percent are aged between 61–70 years old, with a median age of 63 years. Diagnostic tumour samples were obtained for 90% of these patients for multiple parallel sequencing. Patients identified with somatic mutations of potentially “actionable” variants represented almost 10% of those tumours sequenced, while 42% of the cohort had no mutations identified. These genomic data were annotated with information such as cancer site, stage, morphology, treatment and patient outcomes and health resource use and cost. This cohort has delivered its main objective of establishing an upscalable genomics cohort within a clinical setting and in phase 2 aims to develop a protocol for how genomics testing can be used in real-time clinical decision-making, providing evidence on the value of precision medicine to clinical practice. PMID:26529019

  2. "Cancer 2015": A Prospective, Population-Based Cancer Cohort-Phase 1: Feasibility of Genomics-Guided Precision Medicine in the Clinic.

    PubMed

    Parisot, John P; Thorne, Heather; Fellowes, Andrew; Doig, Ken; Lucas, Mark; McNeil, John J; Doble, Brett; Dobrovic, Alexander; John, Thomas; James, Paul A; Lipton, Lara; Ashley, David; Hayes, Theresa; McMurrick, Paul; Richardson, Gary; Lorgelly, Paula; Fox, Stephen B; Thomas, David M

    2015-10-29

    "Cancer 2015" is a longitudinal and prospective cohort. It is a phased study whose aim was to pilot recruiting 1000 patients during phase 1 to establish the feasibility of providing a population-based genomics cohort. Newly diagnosed adult patients with solid cancers, with residual tumour material for molecular genomics testing, were recruited into the cohort for the collection of a dataset containing clinical, molecular pathology, health resource use and outcomes data. 1685 patients have been recruited over almost 3 years from five hospitals. Thirty-two percent are aged between 61-70 years old, with a median age of 63 years. Diagnostic tumour samples were obtained for 90% of these patients for multiple parallel sequencing. Patients identified with somatic mutations of potentially "actionable" variants represented almost 10% of those tumours sequenced, while 42% of the cohort had no mutations identified. These genomic data were annotated with information such as cancer site, stage, morphology, treatment and patient outcomes and health resource use and cost. This cohort has delivered its main objective of establishing an upscalable genomics cohort within a clinical setting and in phase 2 aims to develop a protocol for how genomics testing can be used in real-time clinical decision-making, providing evidence on the value of precision medicine to clinical practice.

  3. Nutritional Risk, Micronutrient Status and Clinical Outcomes: A Prospective Observational Study in an Infectious Disease Clinic.

    PubMed

    Dizdar, Oguzhan Sıtkı; Baspınar, Osman; Kocer, Derya; Dursun, Zehra Bestepe; Avcı, Deniz; Karakükcü, Cigdem; Çelik, İlhami; Gundogan, Kursat

    2016-02-29

    Malnutrition has been associated with increased morbidity and mortality. The objective of this study was to determine the nutritional status and micronutrient levels of hospitalized patients in an infectious disease clinic and investigate their association with adverse clinical outcomes. The nutritional status of the study participants was assessed using the Nutritional Risk Screening 2002 (NRS 2002) and micronutrient levels and routine biochemical parameters were tested within the first 24 h of the patient's admission. The incidence of zinc, selenium, thiamine, vitamin B6, vitamin B12 deficiency were 66.7% (n = 40), 46.6% (n = 29), 39.7% (n = 27), 35.3% (n = 24), 14.1% (n = 9), respectively. Selenium levels were significantly higher in patients with urinary tract infections, but lower in soft tissue infections. Copper levels were significantly higher in patients with soft tissue infections. In the Cox regression models, lower albumin, higher serum lactate dehydrogenase levels and higher NRS-2002 scores were associated with increased death. Thiamine, selenium, zinc and vitamin B6 deficiencies but not chromium deficiencies are common in infectious disease clinics. New associations were found between micronutrient levels and infection type and their adverse clinical outcomes. Hypoalbuminemia and a high NRS-2002 score had the greatest accuracy in predicting death, systemic inflammatory response syndrome and sepsis on admission.

  4. Nutritional Risk, Micronutrient Status and Clinical Outcomes: A Prospective Observational Study in an Infectious Disease Clinic

    PubMed Central

    Dizdar, Oguzhan Sıtkı; Baspınar, Osman; Kocer, Derya; Dursun, Zehra Bestepe; Avcı, Deniz; Karakükcü, Cigdem; Çelik, İlhami; Gundogan, Kursat

    2016-01-01

    Malnutrition has been associated with increased morbidity and mortality. The objective of this study was to determine the nutritional status and micronutrient levels of hospitalized patients in an infectious disease clinic and investigate their association with adverse clinical outcomes. The nutritional status of the study participants was assessed using the Nutritional Risk Screening 2002 (NRS 2002) and micronutrient levels and routine biochemical parameters were tested within the first 24 h of the patient’s admission. The incidence of zinc, selenium, thiamine, vitamin B6, vitamin B12 deficiency were 66.7% (n = 40), 46.6% (n = 29), 39.7% (n = 27), 35.3% (n = 24), 14.1% (n = 9), respectively. Selenium levels were significantly higher in patients with urinary tract infections, but lower in soft tissue infections. Copper levels were significantly higher in patients with soft tissue infections. In the Cox regression models, lower albumin, higher serum lactate dehydrogenase levels and higher NRS-2002 scores were associated with increased death. Thiamine, selenium, zinc and vitamin B6 deficiencies but not chromium deficiencies are common in infectious disease clinics. New associations were found between micronutrient levels and infection type and their adverse clinical outcomes. Hypoalbuminemia and a high NRS-2002 score had the greatest accuracy in predicting death, systemic inflammatory response syndrome and sepsis on admission. PMID:26938553

  5. The internal audit of clinical areas: a pilot of the internal audit methodology in a health service emergency department.

    PubMed

    Brown, Alison; Santilli, Mario; Scott, Belinda

    2015-12-01

    Governing bodies of health services need assurance that major risks to achieving the health service objectives are being controlled. Currently, the main assurance mechanisms generated within the organization are through the review of implementation of policies and procedures and review of clinical audits and quality data. The governing bodies of health services need more robust, objective data to inform their understanding of the control of clinical risks. Internal audit provides a methodological framework that provides independent and objective assurance to the governing body on the control of significant risks. The article describes the pilot of the internal audit methodology in an emergency unit in a health service. An internal auditor was partnered with a clinical expert to assess the application of clinical criteria based on best practice guidelines. The pilot of the internal audit of a clinical area was successful in identifying significant clinical risks that required further management. The application of an internal audit methodology to a clinical area is a promising mechanism to gain robust assurance at the governance level regarding the management of significant clinical risks. This approach needs further exploration and trial in a range of health care settings. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

  6. Voluntary attendance of small-group brainstorming tutoring courses intensify new clerk's "excellence in clinical care": a pilot study.

    PubMed

    Yang, Ling-Yu; Huang, Chia-Chang; Hsu, Hui-Chi; Yang, Ying-Ying; Chang, Ching-Chi; Chuang, Chiao-Lin; Lee, Wei-Shin; Liang, Jen-Feng; Cheng, Hao Min; Huang, Chin-Chou; Lee, Fa-Yauh; Ho, Shung-Tai; Kirby, Ralph

    2017-01-06

    Clerkship provides a unique way of transferring the knowledge and skills gathered during medical school's curriculum into real-ward clinical care environment. The annual program evaluation has indicated that the training of clerks in diagnostic and clinical reasoning skills needed to be enhanced. Recently, "clinical excellence" program have been promoted in our institution to augment the excellence in clinical care of new clerks. Current study aims to evaluate whether this pilot program improve the "clinical excellence" of new clerks. In a pilot study, groups of new clerks in years 2013 and 2014 voluntarily attended either a small-group brainstorming course or a didactic classroom tutoring courses as part of their 3-month internal medicine clinical rotation block. A third group of new clerks did not join either of the above courses and this group served as the control group. Pre-block/post-block self-assessment and post-block 5-station mini-Objective Subjective Clinical Examinations (OSCEs) were used to evaluate the effectiveness of these two additional courses that trained diagnostic and clinical reasoning skills. Overtime, the percentages of new clerks that attended voluntarily either the small-group brainstorming or classroom tutoring courses were increased. Higher post-block self-assessed diagnostic and clinical reasoning skill scores were found among individuals who attended the small-group brainstorming courses compared to either the didactic group or the control group. In a corresponding manner, the small-group brainstorming group obtained higher summary OSCEdiag and OSCEreason scores than either the didactic group or control group. For all basic images/laboratory OSCE stations, the individual diagnostic skill (OSCEdiag) scores of the small-group brainstorming group were higher than those of the didactic group. By way of contrast, only the clinical reasoning skill (OSCEreason) scores of the basic electrocardiogram and complete blood count

  7. The UK clinical aptitude test and clinical course performance at Nottingham: a prospective cohort study

    PubMed Central

    2013-01-01

    Background The UK Clinical Aptitude Test (UKCAT) was introduced in 2006 as an additional tool for the selection of medical students. It tests mental ability in four distinct domains (Verbal Reasoning, Quantitative Reasoning, Abstract Reasoning, and Decision Analysis), and the results are available to students and admission panels in advance of the selection process. Our first study showed little evidence of any predictive validity for performance in the first two years of the Nottingham undergraduate course. The study objective was to determine whether the UKCAT scores had any predictive value for the later parts of the course, largely delivered via clinical placements. Methods Students entering the course in 2007 and who had taken the UKCAT were asked for permission to use their anonymised data in research. The UKCAT scores were incorporated into a database with routine pre-admission socio-demographics and subsequent course performance data. Correlation analysis was followed by hierarchical multivariate linear regression. Results The original study group comprised 204/254 (80%) of the full entry cohort. With attrition over the five years of the course this fell to 185 (73%) by Year 5. The Verbal Reasoning score and the UKCAT Total score both demonstrated some univariate correlations with clinical knowledge marks, and slightly less with clinical skills. No parts of the UKCAT proved to be an independent predictor of clinical course marks, whereas prior attainment was a highly significant predictor (p <0.001). Conclusions This study of one cohort of Nottingham medical students showed that UKCAT scores at admission did not independently predict subsequent performance on the course. Whilst the test adds another dimension to the selection process, its fairness and validity in selecting promising students remains unproven, and requires wider investigation and debate by other schools. PMID:23442227

  8. The UK Clinical Aptitude Test and clinical course performance at Nottingham: a prospective cohort study.

    PubMed

    Yates, Janet; James, David

    2013-02-26

    The UK Clinical Aptitude Test (UKCAT) was introduced in 2006 as an additional tool for the selection of medical students. It tests mental ability in four distinct domains (Verbal Reasoning, Quantitative Reasoning, Abstract Reasoning, and Decision Analysis), and the results are available to students and admission panels in advance of the selection process. Our first study showed little evidence of any predictive validity for performance in the first two years of the Nottingham undergraduate course.The study objective was to determine whether the UKCAT scores had any predictive value for the later parts of the course, largely delivered via clinical placements. Students entering the course in 2007 and who had taken the UKCAT were asked for permission to use their anonymised data in research. The UKCAT scores were incorporated into a database with routine pre-admission socio-demographics and subsequent course performance data. Correlation analysis was followed by hierarchical multivariate linear regression. The original study group comprised 204/254 (80%) of the full entry cohort. With attrition over the five years of the course this fell to 185 (73%) by Year 5. The Verbal Reasoning score and the UKCAT Total score both demonstrated some univariate correlations with clinical knowledge marks, and slightly less with clinical skills. No parts of the UKCAT proved to be an independent predictor of clinical course marks, whereas prior attainment was a highly significant predictor (p <0.001). This study of one cohort of Nottingham medical students showed that UKCAT scores at admission did not independently predict subsequent performance on the course. Whilst the test adds another dimension to the selection process, its fairness and validity in selecting promising students remains unproven, and requires wider investigation and debate by other schools.

  9. Transforming Research and Clinical Knowledge in Traumatic Brain Injury Pilot: Multicenter Implementation of the Common Data Elements for Traumatic Brain Injury

    PubMed Central

    Yue, John K.; Vassar, Mary J.; Lingsma, Hester F.; Cooper, Shelly R.; Okonkwo, David O.; Valadka, Alex B.; Gordon, Wayne A.; Maas, Andrew I. R.; Mukherjee, Pratik; Yuh, Esther L.; Puccio, Ava M.; Schnyer, David M.; Casey, Scott S.; Cheong, Maxwell; Dams-O'Connor, Kristen; Hricik, Allison J.; Knight, Emily E.; Kulubya, Edwin S.; Menon, David K.; Morabito, Diane J.; Pacheco, Jennifer L.; Sinha, Tuhin K.

    2013-01-01

    Abstract Traumatic brain injury (TBI) is among the leading causes of death and disability worldwide, with enormous negative social and economic impacts. The heterogeneity of TBI combined with the lack of precise outcome measures have been central to the discouraging results from clinical trials. Current approaches to the characterization of disease severity and outcome have not changed in more than three decades. This prospective multicenter observational pilot study aimed to validate the feasibility of implementing the TBI Common Data Elements (TBI-CDEs). A total of 650 subjects who underwent computed tomography (CT) scans in the emergency department within 24 h of injury were enrolled at three level I trauma centers and one rehabilitation center. The TBI-CDE components collected included: 1) demographic, social and clinical data; 2) biospecimens from blood drawn for genetic and proteomic biomarker analyses; 3) neuroimaging studies at 2 weeks using 3T magnetic resonance imaging (MRI); and 4) outcome assessments at 3 and 6 months. We describe how the infrastructure was established for building data repositories for clinical data, plasma biomarkers, genetics, neuroimaging, and multidimensional outcome measures to create a high quality and accessible information commons for TBI research. Risk factors for poor follow-up, TBI-CDE limitations, and implementation strategies are described. Having demonstrated the feasibility of implementing the TBI-CDEs through successful recruitment and multidimensional data collection, we aim to expand to additional study sites. Furthermore, interested researchers will be provided early access to the Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) data set for collaborative opportunities to more precisely characterize TBI and improve the design of future clinical treatment trials. (ClinicalTrials.gov Identifier NCT01565551.) PMID:23815563

  10. Transforming research and clinical knowledge in traumatic brain injury pilot: multicenter implementation of the common data elements for traumatic brain injury.

    PubMed

    Yue, John K; Vassar, Mary J; Lingsma, Hester F; Cooper, Shelly R; Okonkwo, David O; Valadka, Alex B; Gordon, Wayne A; Maas, Andrew I R; Mukherjee, Pratik; Yuh, Esther L; Puccio, Ava M; Schnyer, David M; Manley, Geoffrey T

    2013-11-15

    Traumatic brain injury (TBI) is among the leading causes of death and disability worldwide, with enormous negative social and economic impacts. The heterogeneity of TBI combined with the lack of precise outcome measures have been central to the discouraging results from clinical trials. Current approaches to the characterization of disease severity and outcome have not changed in more than three decades. This prospective multicenter observational pilot study aimed to validate the feasibility of implementing the TBI Common Data Elements (TBI-CDEs). A total of 650 subjects who underwent computed tomography (CT) scans in the emergency department within 24 h of injury were enrolled at three level I trauma centers and one rehabilitation center. The TBI-CDE components collected included: 1) demographic, social and clinical data; 2) biospecimens from blood drawn for genetic and proteomic biomarker analyses; 3) neuroimaging studies at 2 weeks using 3T magnetic resonance imaging (MRI); and 4) outcome assessments at 3 and 6 months. We describe how the infrastructure was established for building data repositories for clinical data, plasma biomarkers, genetics, neuroimaging, and multidimensional outcome measures to create a high quality and accessible information commons for TBI research. Risk factors for poor follow-up, TBI-CDE limitations, and implementation strategies are described. Having demonstrated the feasibility of implementing the TBI-CDEs through successful recruitment and multidimensional data collection, we aim to expand to additional study sites. Furthermore, interested researchers will be provided early access to the Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) data set for collaborative opportunities to more precisely characterize TBI and improve the design of future clinical treatment trials. (ClinicalTrials.gov Identifier NCT01565551.).

  11. Why Prospectively Randomized Clinical Trials Have Been Rare in Reproductive Medicine and Will Remain So?

    PubMed

    Gleicher, Norbert; Kushnir, Vitaly A; Barad, David H

    2016-01-01

    There is almost unanimity that modern medicine should be "evidence based." In this context, lack of prospectively randomized clinical trials (RCTs) is widely lamented in reproductive medicine. Some leading voices, indeed, increasingly suggest that only RCT-based clinical conclusions should be integrated into clinical practice, since lower levels of evidence are inadequate. We have argued that reproductive medicine requires special considerations because, like clinical oncology, fertility treatments (especially in older women) are time dependent. Unlike clinical oncology, reproductive medicine, however, does not receive substantial financial research support from government or industry and, at least in the United States, has, therefore, to be primarily funded via patient revenues. Given a 50% chance of receiving placebo, infertility patients are, understandably, reluctant to fund their own RCTs. We here selectively review this subject, contrasting opposing opinions recently published in the literature by a prominent reproductive scientist and one of the world's leading experts on evidence-based medicine. Placing these recent publications into the evolving context of infertility practice, as also addressed in this journal in recent publications, we conclude that objective reasons explain why relatively few RCTs are performed in reproductive medicine and predict that this will not change in the foreseeable future. Reproductive medicine, therefore, has to find ways to develop satisfactory clinical evidence in other ways, satisfying patients' rights to easy access to potentially beneficial medical treatments with low costs and low risks. The RCTs should be reserved for relatively high risk and/or high cost treatments. © The Author(s) 2015.

  12. The use of ultrasonography in learning clinical examination - a pilot study involving third year medical students.

    PubMed

    Fodor, Daniela; Badea, Radu; Poanta, Laura; Dumitrascu, Dan Lucian; Buzoianu, Anca Dana; Mircea, Petru-Adrian

    2012-09-01

    Physical examination is a crucial part in medical student curricula, but a decline in physical examination skills was noted in the last two decades. The benefic role of ultrasonography (US) as an adjuvant method for clinical examination was evaluated in many studies, but there are different approaches among countries and universities. The aim of this study was to evaluate the role of US in learning physical exam in 3rd year medical students. One hundred and four 3rd year medical students were randomly enrolled. They were divided first in two equal groups (I and II, with and without US, by rotation) and then in smaller groups of 8-9 students. Pairs between smaller groups belonging to group I and II were randomly established in order to be trained and evaluated by the same instructor. We verified the influence of US on the correctness of thyroid palpation, lung percussion (inferior limit of the lung), and liver size estimation. They received no special training on US. After the learning sessions (four sessions, one hour each) a questionnaire was applied to each student. For thyroid palpation, there were no significant differences regarding the gland dimensions. For lung and liver palpation the results showed better results for some points in groups using US as adjuvant, but the most significant difference regarded the appreciation of self confidence (in favor of US-groups). The majority of the students using US appreciated as very useful the informations provided by US. Also, we found a clear improvement in detecting the upper limit of the liver comparing with the inferior limit of the lung, as result of better clinical skills. The results from this pilot study proved the utility of US in learning clinical examination. The students can better understand the regional anatomy and can confirm immediately the physical findings. It is important for students to reach a certain level of knowledge regarding physical exam to better understand the role of US. Overall, we can

  13. Clinical results of a pilot study on stereovision-guided stereotactic radiotherapy and intensity modulated radiotherapy.

    PubMed

    Li, Shidong; Kleinberg, Lawrence R; Rigamonti, Daniele; Wharam, Moody D; Rashid, Abdul; Jackson, Juan; Djajaputra, David; He, Shenjen; Creasey, Tunisia; DeWeese, Theodore L

    2010-12-01

    Real-time stereovision-guidance has been introduced for efficient and convenient fractionated stereotactic radiotherapy (FSR) and image-guided intensity-modulated radiation therapy (IMRT). This first pilot study is to clinically evaluate its accuracy and precision as well as impact on treatment doses. Sixty-one FSR patients wearing stereotactic masks (SMs) and nine IMRT patients wearing flexible masks (FMs), were accrued. Daily target reposition was initially based-on biplane-radiographs and then adjusted in six degrees of freedom under real-time stereovision guidance. Mean and standard deviation of the head displacements measured the accuracy and precision. Head positions during beam-on times were measured with real-time stereovisions and used for determination of delivered doses. Accuracy ± ± precision in direction with the largest errors shows improvement from 0.4 ± 2.3 mm to 0.0 ± 1.0 mm in the inferior-to-superior direction for patients wearing SM or from 0.8 ± 4.3 mm to 0.4 ± 1.7 mm in the posterior-to-anterior direction for patients wearing FM. The image-guidance increases target volume coverage by >30% for small lesions. Over half of head position errors could be removed from the stereovision-guidance. Importantly, the technique allows us to check head position during beam-on time and makes it possible for having frameless head refixation without tight masks.

  14. Clinical Results of a Pilot Study on Stereovision-Guided Stereotactic Radiotherapy and Intensity Modulated Radiotherapy

    PubMed Central

    Li, Shidong; Kleinberg, Lawrence R.; Rigamonti, Daniele; Wharam, Moody D.; Rashid, Abdul; Jackson, Juan; Djajaputra, David; He, Shenjen; Creasey, Tunisia; DeWeese, Theodore L.

    2011-01-01

    Real-time stereovision-guidance has been introduced for efficient and convenient fractionated stereotactic radiotherapy (FSR) and image-guided intensity-modulated radiation therapy (IMRT). This first pilot study is to clinically evaluate its accuracy and precision as well as impact on treatment doses. Sixty-one FSR patients wearing stereotactic masks (SMs) and nine IMRT patients wearing flexible masks (FMs), were accrued. Daily target reposition was initially based-on biplane-radiographs and then adjusted in six degrees of freedom under real-time stereovision guidance. Mean and standard deviation of the head displacements measured the accuracy and precision. Head positions during beam-on times were measured with real-time stereovisions and used for determination of delivered doses. Accuracy ± precision in direction with the largest errors shows improvement from 0.4 ± 2.3 mm to 0.0 ± 1.0 mm in the inferior-to-superior direction for patients wearing SM or from 0.8 ± 4.3 mm to 0.4 ± 1.7 mm in the posterior-to-anterior direction for patients wearing FM. The image-guidance increases target volume coverage by >30% for small lesions. Over half of head position errors could be removed from the stereovision-guidance. Importantly, the technique allows us to check head position during beam-on time and makes it possible for having frameless head refixation without tight masks. PMID:21070083

  15. A pilot program of contraceptive continuation in six school-based clinics.

    PubMed

    Bearss, N; Santelli, J S; Papa, P

    1995-09-01

    Few school-based health centers (SBHC) in the United States dispense contraceptives on-site and little is known about contraceptive continuation in these health centers. An 11-month contraceptive continuation pilot project offering monthly reproductive health assessment and counseling to students enrolled in Baltimore school clinics was evaluated. One hundred-forty-three women voluntarily enrolled in the study over a seven month period. A monthly contraceptive calendar was developed to collect data on contraceptive use, pregnancy and STD risk, sexual behavior and parental support for contraceptive use. Physical assessment was provided as needed to assess the presence of STD's or pregnancy. Data were analyzed for the month prior to enrollment in the program and eleven months after entry into the program. Both contraceptive (OCP) use and abstinence increased over the course of the program. Condom use remained at approximately 30% with frequent use of OCP's and condoms, condoms or abstinence. Program drop-out was common. Thirteen students became pregnant while enrolled in the program and 35% of the students were diagnosed with one or more sexually transmitted diseases. Partner-switching was common, although two or more partners within any one month was rare. Monthly follow-up provided through SBHCs can improve contraceptive use although dropout rate and contraceptive failure remain high.

  16. Cardiovascular medicine at face value: a qualitative pilot study on clinical axiology.

    PubMed

    de Hoyos, Adalberto; Nava-Diosdado, Rodrigo; Mendez, Jorge; Ricco, Sergio; Serrano, Ana; Flores Cisneros, Carmen; Macías-Ojeda, Carlos; Cisneros, Héctor; Bialostozky, David; Altamirano-Bustamante, Nelly; Altamirano-Bustamante, Myriam M

    2013-03-27

    Cardiology is characterized by its state-of-the-art biomedical technology and the predominance of Evidence-Based Medicine. This predominance makes it difficult for healthcare professionals to deal with the ethical dilemmas that emerge in this subspecialty. This paper is a first endeavor to empirically investigate the axiological foundations of the healthcare professionals in a cardiology hospital. Our pilot study selected, as the target population, cardiology personnel not only because of their difficult ethical deliberations but also because of the stringent conditions in which they have to make them. Therefore, there is an urgent need to reconsider clinical ethics and Value-Based Medicine. This study proposes a qualitative analysis of the values and the virtues of healthcare professionals in a cardiology hospital in order to establish how the former impact upon the medical and ethical decisions made by the latter. We point out the need for strengthening the roles of healthcare personnel as educators and guidance counselors in order to meet the ends of medicine, as well as the need for an ethical discernment that is compatible with our results, namely, that the ethical values developed by healthcare professionals stem from their life history as well as their professional education. We establish the kind of actions, communication skills and empathy that are required to build a stronger patient-healthcare professional relationship, which at the same time improves prognosis, treatment efficiency and therapeutic adhesion.

  17. Pilot investigation of the correlation between histological and clinical effects of infrared fractional resurfacing lasers.

    PubMed

    Walgrave, Susan; Zelickson, Brian; Childs, James; Altshuler, Gregory; Erofeev, Andrei; Yaroslavsky, Ilya; Kist, David; Counters, Jeff

    2008-11-01

    Yucatan Black pig skin was treated with a 1,540-nm erbium (Er):glass laser (Lux1540, 15 and 30 mJ) and two 1,550-nm Er-doped fiber lasers (Fraxel SR750 and SR1500, 8, 10, and 12 mJ). Histologic sections were examined to determine the depth of damage and to correlate subjects' clinical response. Concurrently, six subjects with photodamaged skin received three split-face and ipsilateral dorsal hand treatments with the 1,540-nm Er:glass laser on one side and one of the 1,550-nm Er-doped lasers (Fraxel SR750) on the other. The 1,550-nm Er-doped lasers, using lower fluences and higher densities, produced shallower micro-columns than the 1,540-nm Er:glass device at higher fluences and lower densities (mean depths 250-275 microm vs 425-525 microm, respectively). Blinded assessors found greater overall improvement in pigmentation with the 1,550-nm Er-doped laser and better overall improvement in texture with the 1,540-nm Er:glass laser. Greater densities of shallower damage columns at lower energies may better improve pigmentation, whereas deeper injuries, using higher energies and moderate densities, may better improve texture. This pilot study did not compare similar fluences and histologic damage between the two systems, and newer available systems allow for greater depth of penetration.

  18. A Pilot Clinical Study of Olfactory Mucosa Autograft for Chronic Complete Spinal Cord Injury.

    PubMed

    Iwatsuki, Koichi; Tajima, Fumihiro; Ohnishi, Yu-Ichiro; Nakamura, Takeshi; Ishihara, Masahiro; Hosomi, Koichi; Ninomiya, Koshi; Moriwaki, Takashi; Yoshimine, Toshiki

    2016-06-15

    Recent studies of spinal cord axon regeneration have reported good long-term results using various types of tissue scaffolds. Olfactory tissue allows autologous transplantation and can easily be obtained by a simple biopsy that is performed through the external nares. We performed a clinical pilot study of olfactory mucosa autograft (OMA) for chronic complete spinal cord injury in eight patients according to the procedure outlined by Lima et al. Our results showed no serious adverse events and improvement in both the American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade and ASIA motor score in five patients. The preoperative post-rehabilitation ASIA motor score improved from 50 in all cases to 52 in case 2, 60 in case 4, 52 in case 6, 55 in case 7, and 58 in case 8 at 96 weeks after OMA. The AIS improved from A to C in four cases and from B to C in one case. Motor evoked potentials (MEPs) were also seen in one patient, reflecting conductivity in the central nervous system, including the corticospinal tract. The MEPs induced with transcranial magnetic stimulation allow objective assessment of the integrity of the motor circuitry comprising both the corticospinal tract and the peripheral motor nerves.We show the feasibility of OMA for chronic complete spinal cord injury.

  19. Laser speckle contrast imaging of cerebral blood flow in humans during neurosurgery: a pilot clinical study

    NASA Astrophysics Data System (ADS)

    Parthasarathy, Ashwin B.; Weber, Erica L.; Richards, Lisa M.; Fox, Douglas J.; Dunn, Andrew K.

    2010-11-01

    Monitoring cerebral blood flow (CBF) during neurosurgery can provide important physiological information for a variety of surgical procedures. CBF measurements are important for assessing whether blood flow has returned to presurgical baseline levels and for assessing postsurgical tissue viability. Existing techniques for intraoperative monitoring of CBF based on magnetic resonance imaging are expensive and often impractical, while techniques such as indocyanine green angiography cannot produce quantitative measures of blood flow. Laser speckle contrast imaging (LSCI) is an optical technique that has been widely used to quantitatively image relative CBF in animal models in vivo. In a pilot clinical study, we adapted an existing neurosurgical operating microscope to obtain LSCI images in humans in real time during neurosurgery under baseline conditions and after bipolar cautery. Simultaneously recorded ECG waveforms from the patient were used to develop a filter that helped reduce measurement variabilities due to motion artifacts. Results from this study demonstrate the feasibility of using LSCI to obtain blood flow images during neurosurgeries and its capability to produce full field CBF image maps with excellent spatial resolution in real-time with minimal disruption to the surgical procedure.

  20. Cardiovascular medicine at face value: a qualitative pilot study on clinical axiology

    PubMed Central

    2013-01-01

    Introduction Cardiology is characterized by its state-of-the-art biomedical technology and the predominance of Evidence-Based Medicine. This predominance makes it difficult for healthcare professionals to deal with the ethical dilemmas that emerge in this subspecialty. This paper is a first endeavor to empirically investigate the axiological foundations of the healthcare professionals in a cardiology hospital. Our pilot study selected, as the target population, cardiology personnel not only because of their difficult ethical deliberations but also because of the stringent conditions in which they have to make them. Therefore, there is an urgent need to reconsider clinical ethics and Value-Based Medicine. This study proposes a qualitative analysis of the values and the virtues of healthcare professionals in a cardiology hospital in order to establish how the former impact upon the medical and ethical decisions made by the latter. Results We point out the need for strengthening the roles of healthcare personnel as educators and guidance counselors in order to meet the ends of medicine, as well as the need for an ethical discernment that is compatible with our results, namely, that the ethical values developed by healthcare professionals stem from their life history as well as their professional education. Conclusion We establish the kind of actions, communication skills and empathy that are required to build a stronger patient-healthcare professional relationship, which at the same time improves prognosis, treatment efficiency and therapeutic adhesion. PMID:23531271

  1. Assessing clinical probability of pulmonary embolism: prospective validation of the simplified Geneva score.

    PubMed

    Robert-Ebadi, H; Mostaguir, K; Hovens, M M; Kare, M; Verschuren, F; Girard, P; Huisman, M V; Moustafa, F; Kamphuisen, P W; Buller, H R; Righini, M; Le Gal, G

    2017-09-01

    Essentials The simplified Geneva score allows easier pretest probability assessment of pulmonary embolism (PE). We prospectively validated this score in the ADJUST-PE management outcome study. The study shows that it is safe to manage patients with suspected PE according to this score. The simplified Geneva score is now ready for use in routine clinical practice. Background Pretest probability assessment by a clinical prediction rule (CPR) is an important step in the management of patients with suspected pulmonary embolism (PE). A limitation to the use of CPRs is that their constitutive variables and corresponding number of points are difficult to memorize. A simplified version of the Geneva score (i.e. attributing one point to each variable) has been proposed but never been prospectively validated. Aims Prospective validation of the simplified Geneva score (SGS) and comparison with the previous version of the Geneva score (GS). Methods In the ADJUST-PE study, which had the primary aim of validating the age-adjusted D-dimer cut-off, the SGS was prospectively used to determine the pretest probability in a subsample of 1621 study patients. Results Overall, PE was confirmed in 294 (18.1%) patients. Using the SGS, 608 (37.5%), 980 (60.5%) and 33 (2%) were classified as having a low, intermediate and high clinical probability. Corresponding prevalences of PE were 9.7%, 22.4% and 45.5%; 490 (30.1%) patients with low or intermediate probability had a D-dimer level below 500 μg L(-1) and 653 (41.1%) had a negative D-dimer test according to the age-adjusted cut-off. Using the GS, the figures were 491(30.9%) and 650 (40.9%). None of the patients considered as not having PE based on a low or intermediate SGS and negative D-dimer had a recurrent thromboembolic event during the 3-month follow-up. Conclusions The use of SGS has similar efficiency and safety to the GS in excluding PE in association with the D-dimer test. © 2017 International Society on Thrombosis and

  2. Evaluating a community-partnered cancer clinical trials pilot intervention with African American communities.

    PubMed

    Green, Melissa A; Michaels, Margo; Blakeney, Natasha; Odulana, Adebowale A; Isler, Malika Roman; Richmond, Alan; Long, Debra G; Robinson, William S; Taylor, Yhenneko J; Corbie-Smith, Giselle

    2015-03-01

    Cancer clinical trial (CCT) accrual and retention rates remain disproportionately low among African Americans. Awarenesss and access to trials are crucial facilitators of trial participation. Strategies developed within a community-based participatory framework (CBPR) are potential solutions to increase awareness and access to CCTs. In this study, we describe the pilot phase of three innovative community-centered modules to improve basic CCT knowledge, awareness of locations to access CCT information, and opportunities to participate in CCTs. Four community organizations completed Community Bridges to CCT training-of-the-trainer and recruited adult African American volunteers to participate in one of three CCT education modules: a workshop about CCTs, a role play describing one person's experience with CCTs, or a call and response session reviewing myths and facts about CCTs. Pre- and post-test surveys were collected and analyzed using McNemar agreement statistic to evaluate changes in knowledge and attitudes regarding trials. Trainers enrolled 125 participants in the call and response (n = 22), role play (n = 60), and workshop (n = 43) modules. Module participants were mostly African American, female, and with a mean age of 53 years. Comparison of pre- and post-test responses demonstrates favorable changes in awareness of CCTs and where to access CCTs across the sample. Analysis by module type indicates significant increases for participants in the call and response (p < 0.01) and role play modules (p < 0.001), but not the workshop module. Despite measures taken to increase the participation and retention rate of African Americans in clinical trials, little advancement has been made. Developing tailored community education modules on CCTs within the CBPR framework is a promising innovation to increase knowledge about CCTs and favorable attitudes about participation that are known precursors to trial enrollment.

  3. A clinical pilot study of lignin--ascorbic acid combination treatment of herpes simplex virus.

    PubMed

    Lopez, Blanca Silvia Gonzalez; Yamamoto, Masaji; Utsumi, Katsuaki; Aratsu, Chiaki; Sakagami, Hiroshi

    2009-01-01

    Antiviral drugs as well as natural remedies have been used to reduce symptoms and the rate of recurrences of herpes simplex virus type 1 (HSV-1) infection, a common disease. To evaluate anti-HSV-1 activity of a pine cone lignin and ascorbic acid treatment, a clinical pilot study was carried out. Forty-eight healthy patients of both genders between 4 and 61 years old (mean: 31+/-16 years), with active lesions of HSV-1, took part in the study. According to the HSV-1 stage at the presentation, the patients were classified into the prodromic (16 patients), erythema (11 patients), papule edema (1 patient), vesicle/pustule (13 patients) and ulcer stages (7 patients). One mg of lignin-ascorbic acid tablet or solution was orally administered three times daily for a month. Clinical evaluations were made daily the first week and at least three times a week during the second week after the onset and every six months during the subsequent year to identify recurrence episodes. The patients who began the lignin-ascorbic acid treatment within the first 48 hours of symptom onset did not develop HSV-1 characteristic lesions, whereas those patients who began the treatment later experienced a shorter duration of cold sore lesions and a decrease in the symptoms compared with previous episodes. The majority of the patients reported the reduction in the severity of symptoms and the reduction in the recurrence episodes after the lignin-ascorbic acid treatment compared with previous episodes, suggesting its possible applicability for the prevention and treatment of HSV-1 infection.

  4. Evaluating a Community-Partnered Cancer Clinical Trials Pilot Intervention with African American Communities

    PubMed Central

    Green, Melissa A.; Michaels, Margo; Blakeney, Natasha; Odulana, Adebowale A.; Isler, Malika Roman; Richmond, Alan; Long, Debra G.; Robinson, William S.; Taylor, Yhenneko J.; Corbie-Smith, Giselle

    2015-01-01

    Objectives Cancer Clinical Trial (CCT) accrual and retention rates remain disproportionately low among African Americans. Awareness and access to trials are crucial facilitators of trial participation. Strategies developed within a community-based participatory framework (CBPR) are potential solutions to increase awareness and access to CCTs. In this study, we describe the pilot phase of three innovative community-centered modules to improve basic CCT knowledge, awareness of locations to access CCT information, and opportunities to participate in CCTs. Design Four community organizations completed Community Bridges to CCTs training-of-the trainer and recruited adult African American volunteers to participate in one of three CCT education modules: a workshop about CCTs; a role-play describing one person's experience with CCTs; or a call and response session reviewing myths and facts about CCTs. Pre- and post-test surveys were collected and analyzed using McNemar agreement statistic to evaluate changes in knowledge and attitudes regarding trials. Results Trainers enrolled 125 participants in the Call and Response (n=22), Role-play (n=60), and Workshop (n=43) modules. Module participants were mostly African American, female, and mean age of 53 years. Comparison of pre and post-test responses demonstrates favorable changes in awareness of CCTs and where to access to CCTs across the sample. Analysis by module type indicates significant increases for participants in the Call and Response (p < 0.01) and Role-Play modules (p < 0.001), but not the Workshop module. Conclusion Despite measures taken to increase the participation and retention rate of African Americans in clinical trials, little advancement has been made. Developing tailored community education modules on CCTs within the CBPR framework is a promising innovation to increase knowledge about CCTs and favorable attitudes about participation that are known precursors to trial enrollment. PMID:25564207

  5. Use of Fentanyl in Adolescents with Clinically Severe Obesity Undergoing Bariatric Surgery: A Pilot Study.

    PubMed

    Vaughns, Janelle D; Ziesenitz, Victoria C; Williams, Elaine F; Mushtaq, Alvina; Bachmann, Ricarda; Skopp, Gisela; Weiss, Johanna; Mikus, Gerd; van den Anker, Johannes N

    2017-06-01

    The number of obese pediatric patients requiring anesthesia is rapidly increasing. Although fentanyl is a commonly used narcotic during surgery, there are no pharmacokinetic (PK) data available for optimal dosing of fentanyl in adolescents with clinically severe obesity. An institutional review board-approved exploratory pilot study was conducted in six adolescents aged 14-19 years undergoing bariatric surgery. Mean total body weight (TBW) and mean BMI were 137.4 ± 14.3 kg and 49.6 ± 6.4 kg/m(2) (99.5th BMI percentile), respectively. Fentanyl was administered intravenously for intraoperative analgesia based on ideal body weight per standard of care. PK blood samples were drawn over a 24-h post-dose period. Fentanyl PK parameters were calculated by non-compartmental analysis. Mean fentanyl AUC0-∞ was 1.5 ± 0.5 h·ng/mL. Systemic clearance of fentanyl was 1522 ± 310 mL/min and 11.2 ± 2.6 mL/min·kg TBW. Volume of distribution was 635 ± 282 L and 4.7 ± 2.1 L/kg TBW. While absolute clearance was increased, absolute volume of distribution was comparable to previously established adult values. These results suggest that fentanyl clearance is enhanced in adolescents with clinically severe obesity while volume of distribution is comparable to previously published studies. NCT01955993 (clinicaltrials.gov).

  6. Blood glucose and schizophrenia: a systematic review of prospective randomized clinical trials.

    PubMed

    Bushe, Chris J; Leonard, Brian E

    2007-11-01

    Most of the data evaluating the potential relationship between diabetes, schizophrenia, and anti-psychotics currently derive from retrospective analysis. Relevant confounders of such data include screening and selection bias. Prospective data collected from randomized controlled trials may reduce such biases. As no single trial has glucose comparisons as a primary endpoint, we undertook a systematic review of available data. Embase, HealthStar, MEDLINE, Pre-MEDLINE, and PsycINFO databases were searched online for relevant articles. Abstracts from major congresses held between January 2000 and April 2006 were included. Search terms included all currently available antipsychotics: olanzapine, risperidone, clozapine, quetiapine, ziprasidone, aripiprazole, haloperidol, chlorpromazine, and zotepine. Prospective clinical trials involving schizophrenia patients with no stated previous glucose abnormalities randomly assigned to cohorts receiving active or placebo comparator antipsychotic medications were included with no restrictions on study length. 16 studies were from peer-reviewed publications, 4 were from posters at major congresses, and 2 were available only on Internet-based sites. Glucose parameters reported included fasting and random glucose and glycosylated hemoglobin. Data reported included mean changes and categorical reports of abnormal levels. Data were available in 6329 patients from 22 trials. The most common comparator agents were aripiprazole and olanzapine in 4 studies including 1432 patients. 14 studies reported fasting and 9 studies reported nonfasting data. 15 studies were a minimum of 5 months, with 8 studies of at least 1 year's duration. No consistent significant glucose differences were found between any comparator antipsychotics or placebo in any trial. In contrast to some of the retrospective data, an analysis of prospective data from randomized clinical trials showed no consistent significant differences in the incidence of treatment

  7. Calcium intake and risk of cardiovascular disease: a review of prospective studies and randomized clinical trials.

    PubMed

    Wang, Lu; Manson, JoAnn E; Sesso, Howard D

    2012-04-01

    The potential effects of inadequate or excessive calcium supply on cardiovascular disease (CVD) are receiving growing attention. We review experimental, epidemiologic, and clinical evidence regarding the role of calcium intake in the development of CVD in adults. In vitro and in vivo laboratory studies have shown that calcium may affect the risk of developing CVD through multiple mechanisms including blood cholesterol, insulin secretion and sensitivity, vasodilation, inflammatory profile, thrombosis, obesity, and vascular calcification. A number of prospective epidemiologic studies have examined the relationship between dietary calcium intake and CVD incidence or mortality in middle-aged and older adults. The results were inconsistent, and the pooled data do not strongly support a significant effect of greater dietary calcium intake on the risk of coronary artery disease (CAD) or stroke. Only a few prospective studies have examined calcium supplement use in association with risk of CVD. The pooled data show no significant benefits of calcium supplement use in reducing the risk of CAD or stroke. No randomized clinical trial has specifically tested the effect of calcium supplementation on CVD as its primary endpoint. Secondary analyses in existing trials to date suggest a neutral effect of calcium (with or without vitamin D) supplements on CVD events, but do not allow for a definitive conclusion. A large percentage of Americans, particularly older adults, fail to meet the US recommendations for optimal calcium intake and are encouraged to increase daily calcium consumption. More prospective cohort studies and large-scale randomized trials are needed to further evaluate the risks or benefits of calcium supplementation on CVD endpoints as the primary pre-specified outcome.

  8. Critical steps in fluoroquinolones and carbapenems prescriptions: results from a prospective clinical audit.

    PubMed

    Seligman, B G S; Ribeiro, R A; Kuchenbecker, R de S; Grings, A O; Dos Santos, R P; Machado, A R L; Casali, F C; Guzatto, F; Morais, V D; Schroeder, G; Küplich, N M; Pires, M R; Konkewicz, L R; Jacoby, T

    2007-01-01

    Antibiotic misuse is associated with emergence of resistance and high expenditures. Fluoroquinolones (FQ) and carbapenems (CP) are drugs with considerable potential of resistance development and its disseminated use is a concern. We undertook a prospective clinical audit to evaluate prescriptions of FQ and CP in a multistep process. Each prescription was unfolded in the following steps: indication for antimicrobial therapy; adequacy of initial prescription, dosage and route; previous cultures; and parenteral-oral transition. There was no antibiotics indication in 8.9% of FQ and 1.5% of CP group (p = 0.07). In CP 25.8% of initial schemes were inappropriate (21% in FQ). Lack of switch to oral therapy comprised 25% of monthly costs of FQ. Inadequacy in initial choice accounted for 13.6% of CP expenses. We concluded that, in spite of infection control restrictive policies, inappropriateness of antibiotic usage is worrisome. Clinical audit in a multistep approach may identify possible flaws in this process.

  9. CT-guided Percutaneous Laser Disc Decompression (PLDD): prospective clinical outcome

    NASA Astrophysics Data System (ADS)

    Brat, Hugues G.; Bouziane, Tarik; Lambert, Jean; Divano, Luisa

    2004-09-01

    Percutaneous Laser Disc Decompression (PLDD) is a minimal invasive and effective treatment for contained lumbar disc hernias with correspondent radicular pain. This prospective study evaluates clinical efficacy of patients treated with PLDD under CT-fluoroscopic guidance. An independent observer assessed clinical outcome in a series of 40 consecutive patients at a mean follow-up of 7.5 months after treatment. According to Mac Nab criteria, 80% of patients experienced a good response to PLDD, 12.5% a fair response and 7.5% a poor response. 37 patients (92.5%) were back at work after 3 weeks. This technique could represent an alternative and secure treatment to conventional surgery for contained disc hernias.

  10. The clinical effect of LLLT in endodontic surgery: a prospective study on 72 cases.

    PubMed

    Payer, Michael; Jakse, Norbert; Pertl, Christoph; Truschnegg, Astrid; Lechner, Evelyn; Eskici, Antranik

    2005-09-01

    The purpose of this prospective study was to evaluate a possible clinical benefit of LLLT in endodontic surgery. Seventy-two endosurgery cases on incisors and premolars were included to the study and were split randomly into an LLLT test group, a placebo group, and a control group. In the LLLT group, irradiation was performed intraoperatively and postoperatively 1, 3, and 7 days after surgery. In the placebo group, irradiation was performed without laser activation. In the control group, neither LLLT nor placebo therapy was used. Swelling, wound healing, and pain were evaluated by a blinded investigator 1, 3, and 7 days postoperatively. No statistically relevant differences between the LLLT and the placebo groups were found. Patients in the control group reported on statistically relevant stronger pain. In routine endodontic surgery cases, LLLT does not achieve a significant clinical benefit. Further, the results indicate a prominent placebo effect of the soft laser therapy.

  11. The frequency and severity of capecitabine-induced hypertriglyceridaemia in routine clinical practice: a prospective study.

    PubMed

    Michie, C O; Sakala, M; Rivans, I; Strachan, M W J; Clive, S

    2010-08-24

    Capecitabine is known to rarely cause raised serum triglycerides (TG). In our centre, several patients receiving capecitabine developed raised TG levels corresponding to the 'very high risk' category for potentially serious acute pancreatitis. A fasting blood lipid screening protocol was introduced into clinical practice for patients receiving capecitabine. Patients with TGs >5 mmol l(-1) were treated and followed up. An 18-month prospective audit was performed to establish the incidence and severity of capecitabine-induced hypertriglyceridaemia (CIHT). A total of 304 patients received capecitabine for colorectal cancer between January 2008 and June 2009. Of these, 212 patients (70%) were screened and 8 (3.7%) developed clinically significant hypertriglyceridaemia requiring lipid-lowering therapy. Two of the eight patients had diabetes and one had pre-existing dyslipidaemia. One suffered cerebral infarction during chemotherapy. There were no cases of acute pancreatitis. Follow-up showed that serum TGs safely and rapidly returned to normal with appropriate treatment without discontinuation of capecitabine. This is the first prospective study evaluating CIHT. These results suggest that it should be classed as a 'common' undesired effect of capecitabine. Despite this, the incidence does not justify routine screening in all patients. Targeted screening in those with diabetes or pre-existing hyperlipidaemia is recommended, together with adoption of a clear management policy.

  12. The frequency and severity of capecitabine-induced hypertriglyceridaemia in routine clinical practice: a prospective study

    PubMed Central

    Michie, C O; Sakala, M; Rivans, I; Strachan, M W J; Clive, S

    2010-01-01

    Background: Capecitabine is known to rarely cause raised serum triglycerides (TG). In our centre, several patients receiving capecitabine developed raised TG levels corresponding to the ‘very high risk' category for potentially serious acute pancreatitis. Methods: A fasting blood lipid screening protocol was introduced into clinical practice for patients receiving capecitabine. Patients with TGs >5 mmol l−1 were treated and followed up. An 18-month prospective audit was performed to establish the incidence and severity of capecitabine-induced hypertriglyceridaemia (CIHT). Results: A total of 304 patients received capecitabine for colorectal cancer between January 2008 and June 2009. Of these, 212 patients (70%) were screened and 8 (3.7%) developed clinically significant hypertriglyceridaemia requiring lipid-lowering therapy. Two of the eight patients had diabetes and one had pre-existing dyslipidaemia. One suffered cerebral infarction during chemotherapy. There were no cases of acute pancreatitis. Follow-up showed that serum TGs safely and rapidly returned to normal with appropriate treatment without discontinuation of capecitabine. Conclusions: This is the first prospective study evaluating CIHT. These results suggest that it should be classed as a ‘common' undesired effect of capecitabine. Despite this, the incidence does not justify routine screening in all patients. Targeted screening in those with diabetes or pre-existing hyperlipidaemia is recommended, together with adoption of a clear management policy. PMID:20664584

  13. A Clinically Meaningful Interpretation of the Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED) Scintigraphic Data.

    PubMed

    Cronin, Paul; Dwamena, Ben A

    2017-05-01

    Pulmonary embolism (PE) is a common condition associated with significant morbidity and mortality. Diagnostic test characteristics reported in terms of sensitivity and specificity are difficult to translate at the clinical level. More relevant measures are likelihood ratios (LRs), which can convert a pretest into a posttest probability. The aim of our study was to calculate the LRs and posttest probabilities for multiple-level test result for ventilation/perfusion (V/Q) lung scintigraphy and for perfusion scintigraphy combined with chest radiography using modified Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED) II and the Prospective Investigative Study of Pulmonary Embolism Diagnosis (PISAPED) criteria for each clinical probability level for the most commonly used clinical prediction rules (CPR) using the PIOPED data. PE pretest probability was estimated for the most commonly used CPRs (Wells, Geneva, Miniati, and Charlotte) at each clinical probability level (two-, three-, and four-level). Multiple-level LRs (high, indeterminate, low, very low probability, and normal) and the positive, indeterminate, and negative results for V/Q scintigraphy, and the positive, indeterminate, and negative results for perfusion scintigraphy were generated and used to calculate posttest probabilities based on the sensitivity and specificity data from PIOPED for each clinical probability level (low, intermediate, and high) for each CPR. Nomograms were also created. The LRs for a positive V/Q and perfusion scintigraphy test using modified PIOPED II and PISAPED criteria were 20.6, 11, and 23.7, and for a negative test result were 0.15, 0.16, and 0.2, respectively. In the three-level Wells score, the posttest probability for an initial low clinical probability PE for a positive, indeterminate, and negative test result, respectively, for V/Q scintigraphy is 56, 5, and 0.9; for perfusion scintigraphy with modified PIOPED 40, 7, and 0.9, and with PISAPED 59, not

  14. High risk clinical characteristics for subarachnoid haemorrhage in patients with acute headache: prospective cohort study.

    PubMed

    Perry, Jeffrey J; Stiell, Ian G; Sivilotti, Marco L A; Bullard, Michael J; Lee, Jacques S; Eisenhauer, Mary; Symington, Cheryl; Mortensen, Melodie; Sutherland, Jane; Lesiuk, Howard; Wells, George A

    2010-10-28

    To identify high risk clinical characteristics for subarachnoid haemorrhage in neurologically intact patients with headache. Multicentre prospective cohort study over five years. Six university affiliated tertiary care teaching hospitals in Canada. Data collected from November 2000 until November 2005. Neurologically intact adults with a non-traumatic headache peaking within an hour. Subarachnoid haemorrhage, as defined by any of subarachnoid haemorrhage on computed tomography of the head, xanthochromia in the cerebrospinal fluid, or red blood cells in the final sample of cerebrospinal fluid with positive results on angiography. Physicians completed data collection forms before investigations. In the 1999 patients enrolled there were 130 cases of subarachnoid haemorrhage. Mean (range) age was 43.4 (16-93), 1207 (60.4%) were women, and 1546 (78.5%) reported that it was the worst headache of their life. Thirteen of the variables collected on history and three on examination were reliable and associated with subarachnoid haemorrhage. We used recursive partitioning with different combinations of these variables to create three clinical decisions rules. All had 100% (95% confidence interval 97.1% to 100.0%) sensitivity with specificities from 28.4% to 38.8%. Use of any one of these rules would have lowered rates of investigation (computed tomography, lumbar puncture, or both) from the current 82.9% to between 63.7% and 73.5%. Clinical characteristics can be predictive for subarachnoid haemorrhage. Practical and sensitive clinical decision rules can be used in patients with a headache peaking within an hour. Further study of these proposed decision rules, including prospective validation, could allow clinicians to be more selective and accurate when investigating patients with headache.

  15. Impact of scribes on patient interaction, productivity, and revenue in a cardiology clinic: a prospective study

    PubMed Central

    Bank, Alan J; Obetz, Christopher; Konrardy, Ann; Khan, Akbar; Pillai, Kamalesh M; McKinley, Benjamin J; Gage, Ryan M; Turnbull, Mark A; Kenney, William O

    2013-01-01

    Objective Scribes have been used in the emergency department to improve physician productivity and patient interaction. There are no controlled, prospective studies of scribe use in the clinic setting. Methods A prospective controlled study compared standard visits (20 minute follow-up and 40 minute new patient) to a scribe system (15 minute follow-up and 30 minute new patient) in a cardiology clinic. Physician productivity, patient satisfaction, physician–patient interaction, and revenue were measured. Results Four physicians saw 129 patients using standard care and 210 patients with scribes during 65 clinic hours each. Patients seen per hour increased (P < 0.001) from 2.2 ± 0.3 to 3.5 ± 0.4 (59% increase) and work relative value units (wRVU) per hour increased (P < 0.001) from 3.5 ± 1.3 to 5.5 ± 1.3 (57% increase). Patient satisfaction was high at baseline and unchanged with scribes. In a substudy, direct patient contact time was lower (9.1 ± 2.0 versus 12.9 ± 3.4 minutes; P < 0.01) for scribe visits, but time of patient interaction (without computer) was greater (6.7 ± 2.1 versus 1.5 ± 1.9 minutes; P < 0.01). Subjective assessment of physician–patient interaction (1–10) was higher (P < 0.01) on scribe visits (9.1 ± 0.9 versus 7.9 ± 1.1). Direct and indirect (downstream) revenue per patient seen was $142 and $2,398, with $205,740 additional revenue generated from the 81 additional patients seen with scribes. Conclusion Using scribes in a cardiology clinic is feasible, produces improvements in physician–patient interaction, and results in large increases in physician productivity and system cardiovascular revenue. PMID:23966799

  16. Multiplex Pathogen Identification for Polymicrobial Urinary Tract Infections Using Biosensor Technology: A Prospective Clinical Study

    PubMed Central

    Mach, Kathleen E.; Du, Christine B.; Phull, Hardeep; Haake, David A.; Shih, Mei-Chiung; Baron, Ellen Jo; Liao, Joseph C.

    2014-01-01

    Purpose Rapid diagnosis of urinary tract infection would have a significant beneficial impact on clinical management, particularly in patients with structural or functional urinary tract abnormalities who are highly susceptible to recurrent polymicrobial infections. We examined the analytical validity of an electrochemical biosensor array for rapid molecular diagnosis of urinary tract infection in a prospective clinical study in patients with neurogenic bladder. Materials and Methods The electrochemical biosensor array was functionalized with DNA probes against 16S rRNA of the most common uropathogens. Spinal cord injured patients at a Veterans Affairs hospital were recruited into the study. Urine samples were generally tested on the biosensor within 1 to 2 hours of collection. Biosensor results were compared with those obtained using standard clinical microbiology laboratory methods. Results We successfully developed a 1-hour biosensor assay for multiplex identification of pathogens. From July 2007 to December 2008 we recruited 116 patients, yielding a total of 109 urine samples suitable for analysis and comparison between biosensor assay and standard urine culture. Of the samples 74% were positive, of which 42% were polymicrobial. We identified 20 organisms, of which Escherichia coli, Pseudomonas aeruginosa and Enterococcus species were the most common. Biosensor assay specificity and positive predictive value were 100%. Pathogen detection sensitivity was 89%, yielding a 76% negative predictive value. Conclusions To our knowledge we report the first prospective clinical study to successfully identify pathogens within a point of care time frame using an electrochemical biosensor platform. Additional efforts to improve the limit of detection and probe design are needed to further enhance assay sensitivity. PMID:19837423

  17. Electrophysiological Predictors of Clinical Outcome in Traumatic Neuropathies: A Multicenter Prospective Study

    PubMed Central

    Mondelli, Mauro; Battiston, Bruno; Sard, Arman; Pontini, Italo; Faccani, Giuliano; Migliaretti, Giuseppe; Cocito, Dario; Neuropathies, Italian Network for Traumatic

    2016-01-01

    Objectives. This prospective, observational, multicentre study aims to identify electrodiagnostic (EDX) markers of clinical recovery in patients with traumatic neuropathy (TN) receiving surgical (S) and nonsurgical (NS) treatments. Methods. Subjects referred to the Italian Traumatic Neuropathy Network between 2010 and 2011 (307 patients, for a total of 444 TN) were evaluated with serial clinical/EDX evaluations at 6, 12, 24, and 36 months of follow-up. Results. Primary surgery was performed in 21 subjects with open lesions and evidence of neurotmesis, while closed lesions were treated with either conservative medical approach (216 patients) or secondary surgery (70 patients), according to the clinical spontaneous recovery at 4–6 months. Clinical improvement correlated with the increase of the compound muscle action potential amplitude (OR 3.76; CI 1.61–8.76), particularly in the S group (OR 7.25; CI 1.2–43.87), and with sensory nerve action potential amplitude in the NS group (OR 4.35; CI 1.14–16.69). No correlations were found with needle electromyography qualitative evaluations, changes in maximal voluntary recruitment, age, and gender. Conclusions. Nerve conduction studies (NCS) represent the more accurate neurophysiological markers of clinical outcome in patients with TN. Significance. Serial NCS assessments predict the functional recovery in TN, increasing the accuracy of peripheral nerves surgical decision-making process. PMID:27547450

  18. Electrophysiological Predictors of Clinical Outcome in Traumatic Neuropathies: A Multicenter Prospective Study.

    PubMed

    Ciaramitaro, Palma; Mondelli, Mauro; Rota, Eugenia; Battiston, Bruno; Sard, Arman; Pontini, Italo; Faccani, Giuliano; Migliaretti, Giuseppe; Merola, Aristide; Cocito, Dario; Neuropathies, Italian Network For Traumatic

    2016-01-01

    Objectives. This prospective, observational, multicentre study aims to identify electrodiagnostic (EDX) markers of clinical recovery in patients with traumatic neuropathy (TN) receiving surgical (S) and nonsurgical (NS) treatments. Methods. Subjects referred to the Italian Traumatic Neuropathy Network between 2010 and 2011 (307 patients, for a total of 444 TN) were evaluated with serial clinical/EDX evaluations at 6, 12, 24, and 36 months of follow-up. Results. Primary surgery was performed in 21 subjects with open lesions and evidence of neurotmesis, while closed lesions were treated with either conservative medical approach (216 patients) or secondary surgery (70 patients), according to the clinical spontaneous recovery at 4-6 months. Clinical improvement correlated with the increase of the compound muscle action potential amplitude (OR 3.76; CI 1.61-8.76), particularly in the S group (OR 7.25; CI 1.2-43.87), and with sensory nerve action potential amplitude in the NS group (OR 4.35; CI 1.14-16.69). No correlations were found with needle electromyography qualitative evaluations, changes in maximal voluntary recruitment, age, and gender. Conclusions. Nerve conduction studies (NCS) represent the more accurate neurophysiological markers of clinical outcome in patients with TN. Significance. Serial NCS assessments predict the functional recovery in TN, increasing the accuracy of peripheral nerves surgical decision-making process.

  19. Mutational landscape of metastatic cancer revealed from prospective clinical sequencing of 10,000 patients.

    PubMed

    Zehir, Ahmet; Benayed, Ryma; Shah, Ronak H; Syed, Aijazuddin; Middha, Sumit; Kim, Hyunjae R; Srinivasan, Preethi; Gao, Jianjiong; Chakravarty, Debyani; Devlin, Sean M; Hellmann, Matthew D; Barron, David A; Schram, Alison M; Hameed, Meera; Dogan, Snjezana; Ross, Dara S; Hechtman, Jaclyn F; DeLair, Deborah F; Yao, JinJuan; Mandelker, Diana L; Cheng, Donavan T; Chandramohan, Raghu; Mohanty, Abhinita S; Ptashkin, Ryan N; Jayakumaran, Gowtham; Prasad, Meera; Syed, Mustafa H; Rema, Anoop Balakrishnan; Liu, Zhen Y; Nafa, Khedoudja; Borsu, Laetitia; Sadowska, Justyna; Casanova, Jacklyn; Bacares, Ruben; Kiecka, Iwona J; Razumova, Anna; Son, Julie B; Stewart, Lisa; Baldi, Tessara; Mullaney, Kerry A; Al-Ahmadie, Hikmat; Vakiani, Efsevia; Abeshouse, Adam A; Penson, Alexander V; Jonsson, Philip; Camacho, Niedzica; Chang, Matthew T; Won, Helen H; Gross, Benjamin E; Kundra, Ritika; Heins, Zachary J; Chen, Hsiao-Wei; Phillips, Sarah; Zhang, Hongxin; Wang, Jiaojiao; Ochoa, Angelica; Wills, Jonathan; Eubank, Michael; Thomas, Stacy B; Gardos, Stuart M; Reales, Dalicia N; Galle, Jesse; Durany, Robert; Cambria, Roy; Abida, Wassim; Cercek, Andrea; Feldman, Darren R; Gounder, Mrinal M; Hakimi, A Ari; Harding, James J; Iyer, Gopa; Janjigian, Yelena Y; Jordan, Emmet J; Kelly, Ciara M; Lowery, Maeve A; Morris, Luc G T; Omuro, Antonio M; Raj, Nitya; Razavi, Pedram; Shoushtari, Alexander N; Shukla, Neerav; Soumerai, Tara E; Varghese, Anna M; Yaeger, Rona; Coleman, Jonathan; Bochner, Bernard; Riely, Gregory J; Saltz, Leonard B; Scher, Howard I; Sabbatini, Paul J; Robson, Mark E; Klimstra, David S; Taylor, Barry S; Baselga, Jose; Schultz, Nikolaus; Hyman, David M; Arcila, Maria E; Solit, David B; Ladanyi, Marc; Berger, Michael F

    2017-06-01

    Tumor molecular profiling is a fundamental component of precision oncology, enabling the identification of genomic alterations in genes and pathways that can be targeted therapeutically. The existence of recurrent targetable alterations across distinct histologically defined tumor types, coupled with an expanding portfolio of molecularly targeted therapies, demands flexible and comprehensive approaches to profile clinically relevant genes across the full spectrum of cancers. We established a large-scale, prospective clinical sequencing initiative using a comprehensive assay, MSK-IMPACT, through which we have compiled tumor and matched normal sequence data from a unique cohort of more than 10,000 patients with advanced cancer and available pathological and clinical annotations. Using these data, we identified clinically relevant somatic mutations, novel noncoding alterations, and mutational signatures that were shared by common and rare tumor types. Patients were enrolled on genomically matched clinical trials at a rate of 11%. To enable discovery of novel biomarkers and deeper investigation into rare alterations and tumor types, all results are publicly accessible.

  20. Improved patient satisfaction using ingenol mebutate gel 0.015% for the treatment of facial actinic keratoses: a prospective pilot study.

    PubMed

    Emilio, Joanna; Schwartz, Michelle; Feldman, Eleanor; Bieber, Amy Kalowitz; Bienenfeld, Amanda; Jung, Min-Kyung; Siegel, Daniel M; Markowitz, Orit

    2016-01-01

    Actinic keratoses (AKs), especially on areas of the face, have a negative impact on a patient's quality of life (QoL). These lesions manifest on sun-damaged skin and have the potential to progress to squamous cell carcinoma. Field-directed therapy alone and in combination with lesion-directed treatment is effective in clearing both visible and nonvisible AK lesions. Topical treatments of AKs thus have the potential to improve a patient's well-being. However, evidence demonstrating improvements in patient QoL is limited, and is mostly based on observational or retrospective studies. Some prospective studies have reported unchanged or even worsening QoL despite excellent treatment outcomes. Our prospective, pilot study demonstrated a significant increase in QoL in 28 subjects with AKs of the face treated with ingenol mebutate gel 0.015%. QoL was assessed at days 0 and 60 using the Skindex-16 survey. Mean overall scores improved from 24.5% at baseline to 15.5% at day 60 (P=0.031). Improvements in QoL were consistent with an 80% reduction in AK lesion number at day 60. These improved QoL findings are in line with those from a recent retrospective study using ingenol mebutate 0.015% gel. This study therefore further demonstrates the potential for field therapy to improve both treatment outcomes and patient satisfaction.

  1. A prospective 9-month human clinical evaluation of Laser-Assisted New Attachment Procedure (LANAP) therapy.

    PubMed

    Nevins, Marc; Kim, Soo-Woo; Camelo, Marcelo; Martin, Ignacio Sanz; Kim, David; Nevins, Myron

    2014-01-01

    This investigation was designed and implemented as a single-center, prospective study to evaluate the clinical response to the Laser-Assisted New Attachment Procedure (LANAP). Eight patients with advanced periodontitis were enrolled and treated with full-mouth LANAP therapy and monitored for 9 months. Fullmouth clinical measurements, including clinical attachment level (CAL), probing depth (PD), and recession, were provided at baseline and after 9 months of healing by a single calibrated examiner, including a total of 930 sites and 444 sites with initial PD equal to or greater than 5 mm. Clinical results for the 930 sites measured pre- and postoperatively revealed that mean PD was reduced from 4.62 ± 2.29 mm to 3.14 ± 1.48 mm after 9 months (P < .05). CAL decreased from 5.58 ± 2.76 mm to 4.66 ± 2.10 mm (P < .05) and recession increased from 0.86 ± 1.31 mm to 1.52 ± 1.62 after 9 months (P < .05). For the subset of 444 sites with initial PD greater than or equal to 5 mm, the PD decreased from 6.50 ± 2.07 mm to 3.92 ± 1.54 mm (P < .05) and CAL decreased from 7.42 ± 2.70 mm to 5.78 ± 2.06 mm (P < .05). As demonstrated by the clinical evaluation, the majority of treated sites demonstrated clinical improvement. LANAP therapy should be further investigated with long-term clinical trials to compare the stability of clinical results with conventional therapy.

  2. Etiology of Cellulitis and Clinical Prediction of Streptococcal Disease: A Prospective Study

    PubMed Central

    Bruun, Trond; Oppegaard, Oddvar; Kittang, Bård R.; Mylvaganam, Haima; Langeland, Nina; Skrede, Steinar

    2016-01-01

    Background. The importance of bacteria other than group A streptococci (GAS) in different clinical presentations of cellulitis is unclear, commonly leading to treatment with broad-spectrum antibiotics. The aim of this study was to describe the etiological and clinical spectrum of cellulitis and identify clinical features predicting streptococcal etiology. Methods. We prospectively enrolled 216 patients hospitalized with cellulitis. Clinical details were registered. Bacterial culture was performed from blood, cutaneous or subcutaneous tissue, and/or swabs from skin lesions. Paired serum samples were analyzed for anti-streptolysin O and anti-deoxyribonuclease B antibodies. Results. Serology or blood or tissue culture confirmed β-hemolytic streptococcal (BHS) etiology in 72% (146 of 203) of cases. An additional 13% (27 of 203) of cases had probable BHS infection, indicated by penicillin response or BHS cultured from skin swabs. β-hemolytic streptococcal etiology was predominant in all clinical subgroups, including patients without sharply demarcated erythema. β-hemolytic group C or G streptococci (GCS/GGS) were more commonly isolated than GAS (36 vs 22 cases). This predominance was found in the lower extremity infections. Group C or G streptococci in swabs were associated with seropositivity just as often as GAS. Staphylococcus aureus was cultured from swabs as a single pathogen in 24 cases, 14 (64%) of which had confirmed BHS etiology. Individual BHS-associated clinical characteristics increased the likelihood of confirmed BHS disease only slightly; positive likelihood ratios did not exceed 2.1. Conclusions. β-hemolytic streptococci were the dominating cause of cellulitis in all clinical subgroups and among cases with S aureus in cutaneous swabs. Group C or G streptococci were more frequently detected than GAS. No single clinical feature substantially increased the probability of confirmed BHS etiology. PMID:26734653

  3. Skill learning in patients with moderate Alzheimer's disease: a prospective pilot-study of waltz-lessons.

    PubMed

    Rösler, Alexander; Seifritz, Erich; Kräuchi, Kurt; Spoerl, David; Brokuslaus, Ilona; Proserpi, Sara-Maria; Gendre, Annekäthi; Savaskan, Egemen; Hofmann, Marc

    2002-12-01

    The authors report the effect of a 12-day prospective, blinded dance-learning trial in 5 patients with moderate Alzheimer's disease (AD) and 5 age-matched depressed patients. Patients with AD showed a significant effect in procedural learning whereas depressed patients did not. These findings suggest potential implications for therapeutic interventions in patients with moderate AD.

  4. Exploring integrative medicine for back and neck pain - a pragmatic randomised clinical pilot trial

    PubMed Central

    Sundberg, Tobias; Petzold, Max; Wändell, Per; Rydén, Anna; Falkenberg, Torkel

    2009-01-01

    relevant difference between groups that was also supported by a small distribution based effect size, i.e. vitality (-7.3 points, Cohen's d -0.34) which was in favour of IM. There was a clinical trend between groups showing that IM contributed to less use of prescription and non-prescription analgesics (-11.7 and - 9.7 percent units respectively) compared to conventional care. Exploring clinically relevant differences and the SF-36 as the basis for a main outcome measure showed that the sample sizes needed per arm to adequately power a full-scale trial depended on the target domain, i.e. ranging from 60 (vitality) to 339 (role emotion). Conclusion This pilot study investigated the implementation of IM in the primary care management of non-specific back and neck pain. Recruiting patients and implementing IM in routine clinical practice was feasible. The results warrant further exploration into different perspectives and relevant combinations of outcome measures including the use of health resources, drugs and cost-effectiveness to help understand the relevance of IM in primary care. Future research should prioritise larger scale studies considering variability, pain duration and small to moderate treatment effects. Trial registration Clinical trials NCT00565942 PMID:19735542

  5. The use of adaptive radiation therapy to reduce setup error: a prospective clinical study.

    PubMed

    Yan, D; Ziaja, E; Jaffray, D; Wong, J; Brabbins, D; Vicini, F; Martinez, A

    1998-06-01

    Adaptive Radiation Therapy (ART) is a feedback treatment process that optimizes a patient's treatment according to the patient specific information measured during the course of treatment. Utilizing an electronic portal imaging device (EPID) and a computer-controlled multileaf collimator (MLC), the ART process is currently being implemented in our clinic to improve the treatment accuracy by compensating for the treatment setup error. A prospective study was conducted to evaluate the feasibility and efficacy of the ART process for clinical use. The prospective study included 20 patients who underwent conventional radiotherapy on a linear accelerator equipped with an EPID and a MLC. No specific changes were made in the routine clinical procedures except daily portal images were obtained for each treatment field. Two-dimensional setup error for each treatment field was then measured offline using a software tool. The measured setup errors from initial treatment days were used to predict the systematic and random setup errors for each treatment field. An adjustment decision was made if the predicted systematic error was larger than or equal to 2 mm. Furthermore, the treatment field was extended if the predicted random setup error could not be effectively compensated by the predefined treatment setup margin. Instead of the conventional approach of patient repositioning, setup adjustment was implemented by reshaping the MLC field. The entire process from measuring setup error to reshaping the MLC field was performed offline through a computer network. After completion of a patient's treatment, the systematic and random setup errors after adjustment were compared with those predicted prior to the adjustment. The accuracy of the adjustment, and the reliability and stability of the process were analyzed. Treatment fields of 13 patients were modified to correct for systematic errors. The mean systematic error was 4 mm with a range of 2 to 7 mm before adjustment. It was

  6. In utero Repair of Myelomeningocele: Rationale, Initial Clinical Experience and a Randomized Controlled Prospective Clinical Trial

    PubMed Central

    Danzer, Enrico; Flake, Alan W.

    2008-01-01

    Myelomeningocele (MMC), one of the most common congenital malformations, can result in severe lifelong disabilities, including paraplegia, hydrocephalus, Arnold-Chiari II malformation, incontinence, sexual dysfunction, skeletal deformations, and mental impairment. MMC was the first nonlethal anomaly to be treated by fetal surgery. Studies in animals provide compelling evidence that the primary cause of the neurological deficit associated with MMC is not simply incomplete neurulation but rather chronic mechanical injury and amniotic-fluid-induced chemical trauma that progressively damage the exposed neural tissue during gestation. Initial results suggest that the surgical repair of MMC before 25 weeks of gestation may preserve neurological function, reverse the hindbrain herniation of the Arnold-Chiari II malformation, and obviate the need for postnatal placement of a ventriculoperitoneal shunt. As it is currently unknown whether fetal surgery for MMC is truly beneficial compared to standard postnatal care, a randomized, controlled clinical trial has been initiated within the United States. PMID:22479081

  7. Clinical pilot study: efficacy of triple antibiotic therapy in Blastocystis positive irritable bowel syndrome patients

    PubMed Central

    2014-01-01

    Background Blastocystis species are common human enteric parasites. Carriage has been linked to Irritable Bowel Syndrome (IBS). Treatment of Blastocystis spp. with antimicrobials is problematic and insensitive diagnostic methods and re-infection complicate assessment of eradication. We investigated whether triple antibiotic therapy comprising diloxanide furoate, trimethoprim/sulfamethoxazole and secnidazole (TAB) given to diarrhoea-predominant IBS (D-IBS) patients positive for Blastocystis would achieve eradication. Methods In a longitudinal, prospective case study 10 D-IBS Blastocystis-positive patients took 14 days of diloxanide furoate 500 mg thrice daily, trimethoprim/sulfamethoxazole 160/80 mg twice daily and secnidazole 400 mg thrice daily. Faecal specimens were collected at baseline, day 15 and 4 weeks after completion of TAB. Specimens were analysed using faecal smear, culture and polymerase chain reaction (PCR) of the 16 SSU rRNA. Patients kept a concurrent clinical diary. Results Six (60%) patients cleared Blastocystis spp. after TAB, including three who had failed previous therapy. Subtypes detected were ST3 (60%), ST4 (40%), ST1 (20%) and ST7, 8 (10%); four patients had mixed ST infections. Serum immunoglobulin A (IgA) levels were low in 40% of patients. Higher rates of Blastocystis clearance were observed in patients symptomatic for less than a year (Mann–Whitney, p = 0.032, 95% confidence) with no associations found with age, previous antibiotic therapy, faecal parasite load, ST, IgA level or clinical improvement. Conclusions Clearance of Blastocystis spp. was achieved with TAB in 60% of D-IBS patients, an improvement over conventional monotherapy. Higher clearance rates are needed to facilitate investigation of the relevance of this parasite in clinically heterogenous IBS. PMID:25349629

  8. Clinical relevance of magnetic resonance imaging in cervical spine clearance: a prospective study.

    PubMed

    Resnick, Shelby; Inaba, Kenji; Karamanos, Efstathios; Pham, Martin; Byerly, Saskya; Talving, Peep; Reddy, Sravanthi; Linnebur, Megan; Demetriades, Demetrios

    2014-09-01

    A missed cervical spine (CS) injury can have devastating consequences. When CS injuries cannot be ruled out clinically using the National Emergency X-Radiography Utilization Study low-risk criteria because of either a neurologic deficit or pain, the optimal imaging modality for CS clearance remains controversial. To investigate the accuracy of computed tomography (CT) and magnetic resonance imaging (MRI) for CS clearance. A prospective observational study was conducted from January 1, 2010, through May 31, 2011, at a level I trauma center. Participants included 830 adults who were awake, alert, and able to be examined who experienced blunt trauma with resultant midline CS tenderness and/or neurologic deficits and were undergoing CT of the CS. Initial examinations, all CS imaging results, interventions, and final CS diagnoses were documented. The criterion standard for the sensitivity and specificity calculations was final diagnosis of CS injury at the time of discharge. Clinically significant CS injuries, defined as injuries requiring surgical stabilization or halo placement. Overall, 164 CS injuries (19.8%) were diagnosed, and 23 of these (2.8%) were clinically significant. All clinically significant injuries were detected by CT. Fifteen of 681 patients (2.2%) with a normal CT scan had a newly identified finding on MRI; however, none of the injuries required surgical intervention or halo placement. There was no change in management on the basis of MRI findings. The sensitivity and specificity of CT for detecting CS injury was 90.9% and 100%, respectively. For clinically significant CS injuries, the sensitivity was 100% and specificity was 100%. Computed tomography is effective in the detection of clinically significant CS injuries in adults deemed eligible for evaluation who had a neurologic deficit or CS pain. Magnetic resonance imaging does not provide any additional clinically relevant information.

  9. Using Social Media While Waiting in Pain: A Clinical 12-Week Longitudinal Pilot Study.

    PubMed

    Merolli, Mark; Gray, Kathleen; Martin-Sanchez, Fernando; Mantopoulos, Steven; Hogg, Malcolm

    2015-08-07

    Chronic pain places an enormous burden on health care systems. Multidisciplinary pain management services are well documented as an effective means to improve patient outcomes. However, waiting lists to access these services are long and outcomes deteriorate. Innovative solutions such as social media are gaining attention as a way to decrease this burden and improve outcomes. It is a challenge to design research that demonstrates whether social media are acceptable to patients and clinically effective. The aim was to conduct a longitudinal pilot study to understand what aspects of research design are key to the success of running a larger-scale study of social media use in the clinical management of chronic pain. A 12-week study examined social media use by patients on the waiting list for the Royal Melbourne Hospital Pain Management Service. Selected social media resources were suggested for use by patients waiting for an appointment at the clinic. Patients filled out measures for pain interference and pain self-efficacy before and after the study. Follow-up was conducted at monthly intervals via telephone semistructured interviews to discuss engagement and garner individual perceptions towards social media use. A social media-use instrument was also administered as part of the after-study questionnaire. Targeted recruitment refined 235 patient referrals to 138 (58.7%) suitable potential participants. Contact was made with 84 out of 138 (60.9%) patients. After a further exclusion of 54 out of 84 (64%) patients for various reasons, this left 30 out of 84 (36%) patients fitting the inclusion criteria and interested in study participation. A final study cohort of 17 out of 30 (57%) was obtained. Demographics of the 17 patients were mixed. Low back pain was the primary condition reported as leading to chronic pain. Semistructured interviews collected data from 16 out of 17 (94%) patients who started the trial, and at final follow-up 9 out of 17 (53%) patients

  10. Pre-clinical and clinical experiences with novel somatostatin ligands: advantages, disadvantages and new prospects.

    PubMed

    Hofland, L J; van der Hoek, J; Feelders, R; van der Lely, A J; de Herder, W; Lamberts, S W J

    2005-01-01

    Since the cloning and characterization of the five human somatostatin receptor (SSTR) subtypes, our understanding of the expression and functional role of the five SSTR subtypes in human (neuro-)endocrine tumors has increased significantly. The majority of human (neuro-)endocrine tumors express multiple SSTR. GH-secreting pituitary adenomas preferentially express SSTR2 and SSTR5, prolactinomas SSTR1 and SSTR5, and corticotroph adenomas express SSTR2 (low number) and predominantly SSTR5s. In addition, gastroenteropancreatic (GEP) neuroendocrine tumors frequently express multiple SSTR as well, with SSTR2 being expressed at the highest level. Treatment with the current generation of octapeptide somatostatin-analogs, e.g. octreotide and lanreotide, normalizes circulating GH- and IGF-I levels in approximately 60-70% of acromegalic patients, thereby remaining about one-third of patients uncontrolled. In patients with GEP neuroendocrine tumors, both somatostatin-analogs effectively suppress the production of bioactive peptides and hormones by the tumor cells, resulting in an important improvement of the related clinical symptomatology. However, a considerable proportion of patients experience an escape from treatment within months to several years. Altogether, the current generation of somatostatin analogs are effective medical tools in the treatment of acromegalic patients and of patients with neuroendocrine GEP tumors, but there is certainly a need for novel somatostatin analogs. In recent years, a significant number of novel somatostatin-ligands has been developed. These ligands include SSTR selective-, bi-specific, universal, as well as chimeric dopamine (DA)-somatostatin ligands. In vitro studies using human pituitary adenoma cells demonstrate a more profound inhibition of GH, PRL and ACTH secretion by somatostatin-analogs targeting both SSTR2s and SSTR5s, compared with SSTR2-preferential somatostatin-analogs. This likely reflects the SSTR subtype expression pattern

  11. Implants in fresh extraction sockets: a prospective 5-year follow-up clinical study.

    PubMed

    Botticelli, Daniele; Renzi, Antonio; Lindhe, Jan; Berglundh, Tord

    2008-12-01

    The aim of this prospective study was to evaluate the 5-year clinical outcome of the 'immediate implants.' One week after the cementation of the prosthesis, a clinical baseline examination was carried out. Clinical measurements were performed of the following: plaque, mucositis, probing pocket depth, and soft tissue position. The height of the keratinized mucosa was measured at the buccal/lingual aspects. Standardized intra-oral radiographs were taken. The marginal level of bone to implant contact [radiographic (Rx) bone level] was measured, and Rx bone level change over time was evaluated. The clinical/radiographic measurements were repeated on a yearly basis. The subjects were enrolled in a carefully supervised oral hygiene program. It was demonstrated that 'immediate implants' that were loaded after 5-7 months had a high success rate. During the 5-year interval, no implant was lost, and the mean Rx bone level at the implants was maintained or even improved. The plaque and mucositis scores were low (<20%) at baseline and at all re-examinations. Implant sites located adjacent to the teeth showed bone gain during the initial period while sites that were facing edentulous zones lost some bone.

  12. [Anterior cervical fusion with tantalum interbody implants. Clinical and radiological results in a prospective study].

    PubMed

    Vicario, C; Lopez-Oliva, F; Sánchez-Lorente, T; Zimmermann, M; Asenjo-Siguero, J J; Ladero, F; Ibarzábal, A

    2006-04-01

    Anterior cervical discectomy and interbody fusion (ACDF) is a widely accepted surgical technique in the treatment of cervical disc disease. Tantalum cages have been recently introduced in spine surgery for interbody fusion because of the advantages of their mechanical properties. We present the results of a prospective clinical and radiological study on 24 consecutive patients who underwent an ACDF with tantalum cages. Clinical evaluation was assessed preoperatively and after surgery by a questionnaire that included a Visual Analogic Scale (VAS) of neck and arm pain, the Oswestry Disability Index and the Zung Depression Scale. Results were classified by Odom's criteria. Radiological evaluation included flexion-extension X-rays, and changes in distance between spinous processes and Cobb angle were measured. Postoperatively patients were reviewed 3 and 12 months after surgery. A statistical significative improvement in all clinical data was reported. According to Odom's criteria in 75% of patients the results were considered like excellent or good. Only one case of radiological and clinical pseudoarthrosis was confirmed. No significative differences were reported 3 and 12 months after surgery. Tantalum cages are a very promising and usefull alternative among implants available for ACDF. Compatibility with MRI postoperative studies and the unnecessariness of autograft are some of their advantages.

  13. A prospective study of the clinical content of palliative medicine interdisciplinary team meetings.

    PubMed

    Powazki, Ruth D; Walsh, Declan; Shrotriya, Shiva

    2015-12-01

    Structured interprofessional communication should improve the structure and clarity of the plan of care. The interdisciplinary team meeting (IDTM) is an opportunity for shared information on patients' and family care needs. We report a prospective observations study of palliative medicine IDTM, which recorded the clinical issues discussed. One hundred and forty-five disparate clinical items were identified for 59 patients and were discussed by the IDTM in about 240 minutes. By content analysis and research meeting consensus, they were grouped into 9 agreed interdisciplinary themes. The 9 themes were then subjected to biostatistical analysis and 3 communication clusters identified. Themes consisted of 3 major communication clusters: (1) clinical services, (2) psychosocial, and (3) care plan. Two themes (information exchange and clinical transitions) did not cluster. The IDTM identified patient care need, reported concerns, and supported collaboration in proactive patient care plans. Future research projects with more patients and a large number of meetings can confirm our findings. This should also examine specific contributions by professional discipline.

  14. Dendritic cell-based vaccines in treating recurrent herpes labialis: Results of pilot clinical study.

    PubMed

    Leplina, Olga; Starostina, Nataliya; Zheltova, Olga; Ostanin, Alexandr; Shevela, Ekaterina; Chernykh, Elena

    2016-12-01

    Recurrent herpes simplex labialis caused predominantly with herpes simplexvirus 1(HSV-1) is a major problem, for which various treatments have minimal impact. Given the important role of the immune system in controlling virus infection, an activation of virus-specific immune responses, in particular,using dendritic cell (DCs) vaccines, seems to be a promising approach for the treatment of patients with frequent recurrences of herpes labialis. The current paper presents the results of a pilot study of the safety and efficacy of DC vaccines in 14 patients with recurrent HSV-1 infections. DCs were generated in presence of GM-CSF and IFN-alpha and were loaded with HSV-1 recombinant viral glycoprotein D (HSV1gD). DCs cells were injected subcutaneously as 2 courses of vaccination during 9 months. Immunotherapy with DCs did not induce any serious side effects and resulted in more than 2-fold reduction in the recurrence rate and significant enhancement of the inter-recurrent time during the 9 months of treatment and subsequent 6-month follow-up period. An obvious clinical improvement was accompanied with an induction of an antigen-specific response to HCV1gD and a normalization of reduced mitogenic responsiveness of mono-nuclear cells. According to long-term survey data (on average 48 months after the beginning of therapy), 87% of respondents reported the decreased incidence of recurrent infection. At this time, most patients (85.7%) responded to HCV1gD stimulation. The data obtained suggests that dendritic cell vaccines may be a promising new approach for the treatment of recurrent labial herpes.

  15. Metformin in Amnestic Mild Cognitive Impairment: Results of a Pilot Randomized Placebo Controlled Clinical Trial.

    PubMed

    Luchsinger, José A; Perez, Thania; Chang, Helena; Mehta, Pankaj; Steffener, Jason; Pradabhan, Gnanavalli; Ichise, Masanori; Manly, Jennifer; Devanand, Davangere P; Bagiella, Emilia

    2016-01-01

    Diabetes and hyperinsulinemia may be risk factors for Alzheimer's disease (AD). We conducted a pilot study of metformin, a medication efficacious in treating and preventing diabetes while reducing hyperinsulinemia, among persons with amnestic mild cognitive impairment (aMCI) with the goal of collecting preliminary data on feasibility, safety, and efficacy. Participants were 80 men and women aged 55 to 90 years with aMCI, overweight or obese, without treated diabetes. We randomized participants to metformin 1000 mg twice a day or matching placebo for 12 months. The co-primary clinical outcomes were changes from baseline to 12 months in total recall of the Selective Reminding Test (SRT) and the score of the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog). The secondary outcome was change in relative glucose uptake in the posterior cingulate-precuneus in brain fluorodeoxyglucose positron emission tomography. Change in plasma Aβ42 was an exploratory outcome. The mean age of participants was 65 years. Fifty percent of participants were women. The only baseline variable that was different between the arms was the ADAS-Cog. Metformin could not be tolerated by 7.5% of participants; 15% tolerated 500 mg/day, 35% tolerated 1000 mg/day, 32.5% tolerated 1500 mg/day, and only 10% tolerated the maximum dose. There were no serious adverse events related to metformin. The 7.5% of persons who did not tolerate metformin reported gastrointestinal symptoms. After adjusting for baseline ADAS-cog, changes in total recall of the SRT favored the metformin group (9.7±8.5 versus 5.3±8.5; p = 0.02). Differences for other outcomes were not significant. A larger trial seems warranted to evaluate the efficacy and cognitive safety of metformin in prodromal AD.

  16. Unannounced telephone pill counts for assessing varenicline adherence in a pilot clinical trial

    PubMed Central

    Thompson, Nia; Nazir, Niaman; Cox, Lisa Sanderson; Faseru, Babalola; Goggin, Kathy; Ahluwalia, Jasjit S; Nollen, Nicole L

    2011-01-01

    Background Despite consistent evidence linking smoking cessation pharmacotherapy adherence to better outcomes, knowledge about objective adherence measures is lacking and little attention is given to monitoring pharmacotherapy use in smoking cessation clinical trials. Objectives To examine unannounced telephone pill counts as a method for assessing adherence to smoking cessation pharmacotherapy. Research design Secondary data analysis of a randomized pilot study. Participants 46 moderate-to-heavy (>10 cigarettes per day) African-American smokers. Main measures Smokers received 1 month of varenicline (Pfizer Global Pharmaceuticals, New York, NY) in a pill box at baseline. Unannounced pill counts were completed by telephone 4 days prior to an in-person pill count conducted at Month 1. At both counts, each compartment of the pill box was opened and the number of remaining pills was recorded. Results Participants were a mean age of 48 years (SD = 13), predominately female (59%), low income (60% < $1800 monthly family income), and smoked an average of 17 (SD = 7) cigarettes per day. A high degree of concordance was observed between the number of pills counted by phone and in-person (rs = 0.94, P < 0.001). Participants with discordant counts (n = 7) had lower varenicline adherence (mean [SD] = 77% [18%] vs 95% [9%], P < 0.0005), but reported better medication adherence in the past (1.0 [0.8] vs 2.8 [1.0], P < 0.0004) than participants with matching phone and in-person counts (n = 39). Conclusion Unannounced telephone pill counts appear to be a reliable and practical method for measuring adherence to smoking cessation pharmacotherapy. PMID:22003285

  17. Metformin in Amnestic Mild Cognitive Impairment: results of a pilot randomized placebo controlled clinical trial

    PubMed Central

    Luchsinger, José A.; Perez, Thania; Chang, Helena; Mehta, Pankaj; Steffener, Jason; Pradabhan, Gnanavalli; Ichise, Masanori; Manly, Jennifer; Devanand, Devangere P.; Bagiella, Emilia

    2016-01-01

    Diabetes and hyperinsulinemia may be risk factors for Alzheimer's disease (AD). We conducted a pilot study of metformin, a medication efficacious in treating and preventing diabetes while reducing hyperinsulinemia, among persons with amnestic mild cognitive impairment (AMCI) with the goal of collecting preliminary data on feasiblity, safety, and efficacy. Participants were 80 men and women aged 55 to 90 years with AMCI, overweight or obese, without treated diabetes. We randomized participants to metformin 1000 mg twice a day or matching placebo for 12 months. The co-primary clinical outcomes were changes from baseline to 12 months in total recall of the Selective Reminding Test (SRT) and the score of the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog). The secondary outcome was change in relative glucose uptake (rCMRgl) in the posterior cingulate-precuneus in brain Fluorodeoxyglucose Positron Emission Tomography. Change in plasma Aβ42 was an exploratory outcome. The mean age of participants was 65 years. Fifty % of participants were women. The only baseline variable that was different between the arms was the ADAS-Cog. Metformin could not be tolerated by 7.5% of participants; 15% tolerated 500 mg/day, 35% tolerated 1000 mg/day, 32.5% tolerated 1500 mg/day, and only 10% tolerated the maximum dose. There were no serious adverse events related to metformin. The 7.5% of persons who did not tolerate metformin reported gastrointestinal symptoms. After adjusting for baseline ADAS-cog, changes in total recall of the SRT favored the metformin group (9.7 ± 8.5 vs. 5.3 ± 8.5; p = 0.02). Differences for other outcomes were not significant. A larger trial seems warranted to evaluate the efficacy and cognitive safety of metformin in prodromal AD. PMID:26890736

  18. Clinical rating scale for pantothenate kinase-associated neurodegeneration: A pilot study.

    PubMed

    Darling, Alejandra; Tello, Cristina; Martí, María Josep; Garrido, Cristina; Aguilera-Albesa, Sergio; Tomás Vila, Miguel; Gastón, Itziar; Madruga, Marcos; González Gutiérrez, Luis; Ramos Lizana, Julio; Pujol, Montserrat; Gavilán Iglesias, Tania; Tustin, Kylee; Lin, Jean Pierre; Zorzi, Giovanna; Nardocci, Nardo; Martorell, Loreto; Lorenzo Sanz, Gustavo; Gutiérrez, Fuencisla; García, Pedro J; Vela, Lidia; Hernández Lahoz, Carlos; Ortigoza Escobar, Juan Darío; Martí Sánchez, Laura; Moreira, Fradique; Coelho, Miguel; Correia Guedes, Leonor; Castro Caldas, Ana; Ferreira, Joaquim; Pires, Paula; Costa, Cristina; Rego, Paulo; Magalhães, Marina; Stamelou, María; Cuadras Pallejà, Daniel; Rodríguez-Blazquez, Carmen; Martínez-Martín, Pablo; Lupo, Vincenzo; Stefanis, Leonidas; Pons, Roser; Espinós, Carmen; Temudo, Teresa; Pérez Dueñas, Belén

    2017-08-28

    Pantothenate kinase-associated neurodegeneration is a progressive neurological disorder occurring in both childhood and adulthood. The objective of this study was to design and pilot-test a disease-specific clinical rating scale for the assessment of patients with pantothenate kinase-associated neurodegeneration. In this international cross-sectional study, patients were examined at the referral centers following a standardized protocol. The motor examination was filmed, allowing 3 independent specialists in movement disorders to analyze 28 patients for interrater reliability assessment. The scale included 34 items (maximal score, 135) encompassing 6 subscales for cognition, behavior, disability, parkinsonism, dystonia, and other neurological signs. Forty-seven genetically confirmed patients (30 ± 17 years; range, 6-77 years) were examined with the scale (mean score, 62 ± 21; range, 20-106). Dystonia with prominent cranial involvement and atypical parkinsonian features were present in all patients. Other common signs were cognitive impairment, psychiatric features, and slow and hypometric saccades. Dystonia, parkinsonism, and other neurological features had a moderate to strong correlation with disability. The scale showed good internal consistency for the total scale (Cronbach's α = 0.87). On interrater analysis, weighted kappa values (0.30-0.93) showed substantial or excellent agreement in 85% of the items. The scale also discriminated a subgroup of homozygous c.1583C>T patients with lower scores, supporting construct validity for the scale. The proposed scale seems to be a reliable and valid instrument for the assessment of pediatric and adult patients with pantothenate kinase-associated neurodegeneration. Additional validation studies with a larger sample size will be required to confirm the present results and to complete the scale validation testing. © 2017 International Parkinson and Movement Disorder Society. © 2017 International Parkinson and Movement

  19. Is There a Benefit to Drains with a Kocher-Langenbeck Approach? A Prospective Randomized Pilot Study

    DTIC Science & Technology

    2010-11-01

    HO, Kaukonen JP, Salo SA. Drainage is of no use in primary uncomplicated cemented hip and knee arthroplasty for osteoarthritis : a prospective...their posterior wall fractures. One patient had an open fracture with communication between the rectum and the hip joint. All patients underwent open...the frequent presence of damaged and contused muscle about the hip as an additional reason for the use of drains. Closed suction drains cannot be

  20. Clinical Characteristics of Microscopic Colitis in Korea: Prospective Multicenter Study by KASID

    PubMed Central

    Baek, Dae Hyun; Kim, Won Ho; Kim, Joo Sung; Yang, Suk-Kyun; Jung, Sung-Ae; Jang, Byung Ik; Choi, Chnag Hwan; Han, Dong Soo; Kim, Young-Ho; Chung, Yong Woo; Kim, Sang Woo; Kim, You Sun

    2011-01-01

    Background/Aims Microscopic colitis (MC) encompasses collagenous and lymphocytic colitis and is characterized by chronic diarrhea. In cases of MC, colonic mucosae are macroscopically normal, and diagnostic histopathological features are observed only upon microscopic examination. We designed a prospective multicenter study to determine the clinical features, pathological distribution in the colon and prevalence of MC in Korea. Methods We prospectively enrolled patients having watery diarrhea no more than 3 times a day between March 2008 and February 2009. We obtained patient histories and performed colonoscopies with random biopsies at each colon segment. Results A total of 100 patients with chronic diarrhea were enrolled for a normal colonoscopy and stool exam. MC was observed in 22 patients (22%) (M:F 1.2:1; mean age, 47.5 years). Of those 22 patients, 18 had lymphocytic colitis and 4 had collagenous colitis. The entire colon was affected in only 3 cases (13.6%), the ascending colon in 6 cases (27.2%), the transverse colon in 3 cases (13.6%), and the left colon in 3 cases (13.6%). More than 2 segments were affected in 7 cases (31.8%). Nonsteroidal anti-inflammatory drug-associated MCs were observed in 4 cases (18.2%), 3 of which showed improved diarrhea symptoms following discontinuation of the medication. Frequently associated symptoms were abdominal pain and weight loss. Autoimmune diseases were observed in 4 cases (18.2%). Half of the 22 patients with MC improved with conservative care by loperamide or probiotics. Conclusions In a prospective multicenter study of Korean patients with chronic diarrhea, the frequency of MC was found to be approximately 20%, similar to the percentage observed in Western countries. Therefore, the identification of MC is important for the adequate management of Korean patients with chronic diarrhea. PMID:21814598

  1. Using Vascular Quality Initiative as a Platform for Organizing Multicenter, Prospective, Randomized Clinical Trials: OVERPAR Trial

    PubMed Central

    Eslami, Mohammad H.; Doros, Gheorghe; Goodney, Philip P.; Elderup-Jorgenson, Jens; Cronenwett, Jack L.; Malikova, Marina; Farber, Alik

    2014-01-01

    Background We describe the organization of a prospective, randomized, multicenter trial comparing the effectiveness of open popliteal artery aneurysm repair (OPAR) and endovascular popliteal artery aneurysm repair (EPAR) of asymptomatic popliteal artery aneurysms (PAAs) as an example for how to use the Vascular Quality Initiative (VQI) framework. Given that many centers participate in the VQI, this model can be used to perform multicenters’ prospective trials on very modest budget. Methods VQI prospectively collects data on many vascular procedures. These data include many important perioperative, intraoperative, and postoperative details regarding both patients and their procedures. We describe a study where minimal changes to the collected data by participating centers can provide level-1 evidence regarding a significant clinical question. Data will be collected using modified VQI forms within the existing VQI data reporting structure. We plan to enroll 148 patients with asymptomatic PAAs into the open and endovascular surgery cohorts. Patients from participating VQI centers will be randomized 1:1 to either OPAR or EPAR and will be followed for an average of 2.5 years. Our primary hypothesis is that major adverse limb event–free survival is lower in the EPAR cohort and that EPAR is associated with more secondary interventions, improved quality of life, and decreased length of stay. The budget for this trial is fixed at $10,000/year for the course of the study, and the trial is judged to be feasible because of the functionality of the VQI platform. Conclusions Using the existing VQI infrastructure, Open versus Endovascular Repair of Popliteal Artery Aneurysm will provide level 1 data for PAA treatment on a modest budget. The proposed trial has an adequately powered comparative design that will use objective performance goals to describe limb-related morbidity and procedural reintervention rates. PMID:25311746

  2. Prospective study on the clinical course and outcomes in transfusion-related acute lung injury*.

    PubMed

    Looney, Mark R; Roubinian, Nareg; Gajic, Ognjen; Gropper, Michael A; Hubmayr, Rolf D; Lowell, Clifford A; Bacchetti, Peter; Wilson, Gregory; Koenigsberg, Monique; Lee, Deanna C; Wu, Ping; Grimes, Barbara; Norris, Philip J; Murphy, Edward L; Gandhi, Manish J; Winters, Jeffrey L; Mair, David C; Schuller, Randy M; Hirschler, Nora V; Rosen, Rosa Sanchez; Matthay, Michael A; Toy, Pearl

    2014-07-01

    Transfusion-related acute lung injury is the leading cause of transfusion-related mortality. A prospective study using electronic surveillance was conducted at two academic medical centers in the United States with the objective to define the clinical course and outcomes in transfusion-related acute lung injury cases. Prospective case study with controls. University of California, San Francisco and Mayo Clinic, Rochester. We prospectively enrolled 89 patients with transfusion-related acute lung injury, 164 transfused controls, and 145 patients with possible transfusion-related acute lung injury. None. Patients with transfusion-related acute lung injury had fever, tachycardia, tachypnea, hypotension, and prolonged hypoxemia compared with controls. Of the patients with transfusion-related acute lung injury, 29 of 37 patients (78%) required initiation of mechanical ventilation and 13 of 53 (25%) required initiation of vasopressors. Patients with transfusion-related acute lung injury and possible transfusion-related acute lung injury had an increased duration of mechanical ventilation and increased days in the ICU and hospital compared with controls. There were 15 of 89 patients with transfusion-related acute lung injury (17%) who died, whereas 61 of 145 patients with possible transfusion-related acute lung injury (42%) died and 7 of 164 of controls (4%) died. Patients with transfusion-related acute lung injury had evidence of more systemic inflammation with increases in circulating neutrophils and a decrease in platelets compared with controls. Patients with transfusion-related acute lung injury and possible transfusion-related acute lung injury also had a statistically significant increase in plasma interleukin-8, interleukin-10, and interleukin-1 receptor antagonist posttransfusion compared with controls. In conclusion, transfusion-related acute lung injury produced a condition resembling the systemic inflammatory response syndrome and was associated with

  3. Prospective evaluation of a clinical guideline recommending hospital length of stay in upper gastrointestinal tract hemorrhage.

    PubMed

    Hay, J A; Maldonado, L; Weingarten, S R; Ellrodt, A G

    Upper gastrointestinal tract hemorrhage (UGIH) is a common and potentially life-threatening disorder. Resource utilization can vary without adverse effect on patient outcome. Clinical practice guidelines are a potential solution to reduce variation in practice while improving patient outcomes. To validate prospectively the safety, acceptability, and impact of a clinical practice guideline defining the medically appropriate length of stay (LOS) for patients hospitalized with UGIH. Prospective, controlled time-series study with an alternate-month design. Outcome surveyors and patients were blinded to study group allocation. GUIDELINE: A retrospectively validated scoring system using 4 independent variables: hemodynamics, time from bleeding, comorbidity, and esophagogastroduodenoscopy (EGD) findings to predict risk of adverse events. The quantitative risk for the low-risk subset was 0.6% (95% confidence interval [CI], 0.0%-2.0%) for subsequent complications and 0% (95% CI, 0.0%-0.9%) for life-threatening complications from this retrospective evaluation. A 1000-bed, not-for-profit, university-affiliated teaching hospital. Consecutive adult patients hospitalized for acute UGIH. Concurrent feedback of guideline recommendation (same-day hospital discharge) to physicians caring for patients at low risk for complication. No risk information was provided during control months. Seventy percent (209/299) of UGIH patients achieved low-risk status according to the guideline and were therefore potentially suitable for early discharge from the hospital. Providing real-time quantitative risk information (intervention group only) was associated with an increase in guideline compliance from 30% to 70% (P<.001) and a decrease in mean (SD) LOS from 4.6 (3.5) days to 2.9 (1.3) days (mean reduction of 1.7 days per patient; P<.001). No differences in complications, patient health status, or patient satisfaction were found when measured 1 month after discharge. An independent variable

  4. Navigation of total knee arthroplasty: rotation of components and clinical results in a prospectively randomized study

    PubMed Central

    2011-01-01

    Background Navigation was introduced into total knee arthroplasty (TKA) to improve accuracy of component position, function and survival of implants. This study was designed to assess the outcome of navigated TKA in comparison with conventional implantation with the focus on rotational component position and clinical mid-term results. Methods In a prospectively randomized single-blinded approach, 90 patients with primary gonarthrosis were assigned to three different groups. Thirty patients each were assigned to NexGen LPS without and with navigation (groups 1 and 2), and 30 patients to navigation with the Stryker Scorpio PS (group 3). The navigation system used was the imageless Stryker KneeTrac, version 1.0. Clinical outcome was assessed by a blinded observer applying the Knee Society Score (KSS) and a visual analogue scale (VAS) for pain. CT scans and radiographs were conducted prior to and 12 weeks after index surgery. Results Seventy-nine patients were available for clinical evaluation at 3 ± 0.4 years follow-up. Four implants had to be revised for early loosening or infection (4.4%). Four patients had died and three patients were not able to follow the invitation for clinical assessment. Functional results in the KSS were significantly lower after navigated TKA. Operation time and incisions with navigation were significantly longer. Significantly less radiological outliers with navigation were found for coronal alignment of the femur, only. Conclusion In this series, no beneficial effect for navigation in TKA could be shown assessing clinical data, as functional results in the presented series seemed to be lower after first generation navigated TKA. The clinical mid- to long-term value of navigation remains to be evaluated in larger patient series or meta-analyses at longer follow-up. Trial registration number DRKS 00000430 PMID:21235810

  5. Laparoendoscopic single-site versus conventional laparoscopic total extraperitoneal hernia repair: a prospective randomized clinical trial.

    PubMed

    Tsai, Yao-Chou; Ho, Chen-Hsun; Tai, Huai-Ching; Chung, Shiu-Dong; Chueh, Shih-Chieh

    2013-12-01

    This study aimed to compare laparoendoscopic single-site (LESS) total extraperitoneal (TEP) repair with conventional laparoscopic TEP repair for the treatment of inguinal hernias. To date, no other studies have compared the LESS and conventional laparoscopic TEP approaches for the treatment of inguinal hernia in a prospective randomized study setting. For this study, 100 patients undergoing inguinal hernia repair were prospectively randomized into either the LESS TEP group or the conventional laparoscopic TEP group. Pre-, intra-, and postoperative factors were recorded. The primary end point was postoperative pain. The patients were interviewed at outpatient clinics at 1 week, 3 months, and 6 months postoperatively. The demographic data were comparable between the two groups. The median operative time was longer in the LESS TEP group (63.5 min) than in the conventional TEP group (50.5 min) (p = 0.001). No conversion was performed in either group. The mean pain score 2 h postoperatively during rest was significantly higher in the conventional TEP group than in the LESS TEP group (3.9 vs. 2.6; p = 0.02). The postoperative results were comparable between the groups in terms of analgesic requirements, systemic stress responses, complications, and postoperative convalescence. The LESS TEP technique is associated with a longer operative time but offers the minor benefit of a reduction in immediate postoperative pain.

  6. Lidocaine versus mepivacaine in sedated pediatric dental patients: randomized, prospective clinical study.

    PubMed

    Çalış, Aylin Sipahi; Cagiran, Esra; Efeoglu, Candan; Ak, Aslı Topaloglu; Koca, Huseyın

    2014-01-01

    Dental anxiety is usually seen in the pediatric patients. specially in the case of minor oral surgical procedures and exodontia, cooperation of the patients and their families with the dentist will lead to superior treatment outcomes. Pain control is important in dentistry. The aim of this randomized prospective clinical study is to compare the local anaesthetic and haemodynamic effects of 2% lidocaine (Group 1) and 3% mepivacaine (Group 2) in sedated pediatric patients undergoing primary tooth extraction. 60 pediatric patients undergoing sedation for elective primary tooth extraction was prospectively included in the study in a randomized fashion. Inclusion and exclusion criteria were assigned. Patients were given premedication via oral route. Local anesthesia was achieved before extraction(s). There were no significant differences between the groups in patient demographics, number of teeth extracted, duration of the operation and time from the end of the procedure to discharge (p ≥ 0.05). FLACC pain scale scores were not statistically significant between the groups, except at 20 minutes post-operatively when the score is significantly lower in Group 2 (p=0.029). Prevention of pain during dental procedures can nurture the relationship of the patient and dentist. Tooth extraction under sedation in pediatric patients could be safe with both local anesthetics.

  7. Topical Allium ampeloprasum subsp Iranicum (Leek) extract cream in patients with symptomatic hemorrhoids: a pilot randomized and controlled clinical trial.

    PubMed

    Mosavat, Seyed Hamdollah; Ghahramani, Leila; Sobhani, Zahra; Haghighi, Ehsan Rahmanian; Heydari, Mojtaba

    2015-04-01

    Allium ampeloprasum subsp iranicum (Leek) has been traditionally used in antihemorrhoidal topical herbal formulations. This study aimed to evaluate its safety and efficacy in a pilot randomized controlled clinical trial. Twenty patients with symptomatic hemorrhoids were randomly allocated to receive the topical leek extract cream or standard antihemorrhoid cream for 3 weeks. The patients were evaluated before and after the intervention in terms of pain, defecation discomfort, bleeding severity, anal itching severity, and reported adverse events. A significant decrease was observed in the grade of bleeding severity and defecation discomfort in both the leek and antihemorrhoid cream groups after the intervention, while no significant change was observed in pain scores. There was no significant difference between the leek and antihemorrhoid cream groups with regard to mean changes in outcome measures. This pilot study showed that the topical use of leek cream can be as effective as a standard antihemorrhoid cream. © The Author(s) 2015.

  8. Glucocorticoid insensitive asthma: a one year clinical follow up pilot study

    PubMed Central

    Demoly, P.; Jaffuel, D.; Mathieu, M.; Sahla, H.; Godard, P.; Michel, F.; Bousquet, J.

    1998-01-01

    BACKGROUND—Glucocorticoid resistant or insensitive asthmatic subjects are usually defined as patients whose baseline pre-bronchodilation forced expiratory volume in one second (FEV1) of less than 70-80% predicted improves significantly in response to β2 agonists but by less than 15% following 1-2 weeks of 40 mg prednisolone daily. Since there is little long term clinical information on these patients, a one year prospective study was performed to assess whether glucocorticoid sensitivity may vary over time.
METHODS—Nineteen severe asthmatic subjects were studied and received 40 mg prednisolone daily for seven days. Prednisolone was given for a further seven days in glucocorticoid insensitive asthmatics and then stopped. Patients were followed up for one year and the glucocorticoid test was repeated on five patients in each group six months later.
RESULTS—Eleven patients were classified as glucocorticoid insensitive and eight as glucocorticoid sensitive on day 7. The demographic characteristics of the patients were similar in both groups. Four glucocorticoid insensitive patients became responsive after one further week of prednisolone treatment. Six months later, four of five glucocorticoid sensitive patients and three of five previously glucocorticoid insensitive patients were glucocorticoid sensitive.
CONCLUSIONS—Glucocorticoid sensitivity varies over time.

 PMID:10195080

  9. Effects of Er:YAG laser in caries treatment: a clinical pilot study.

    PubMed

    Keller, U; Hibst, R

    1997-01-01

    Various lasers have been suggested for cavity preparation. Pain reduction is expected as a potential benefit of laser usage. Among the systems studied in vitro, the Er:YAG laser offers a distinct combination of high ablation efficiency and low thermal side effects. Animal studies demonstrated that pulp damage can be avoided when appropriate laser parameters are used. The present prospective clinical study was intended to test the practical applicability of the system and to investigate the patient's response. The study population consisted of 67 teeth on 33 subjects. Patient's reaction to pain was documented in four categories: no pain, little pain (like a brief pressure to the tooth), medium pain (like needle sticks), and strong pain (like a thermal shock test). For superficial cavities 200 pulses (SD: 114) were needed. At a pulse repetition rate of 2 Hz, the preparation time was 1.6 min (SD: 2.1 min). Deeper cavities required 391 pulses (SD: 251), or approximately 3.3 min (SD: 2.1 min). No loss in pulp vitality was observed. In 36% of the laser-treated teeth, no pain was felt, and in 57%, little pain was reported. With one exception, no local anesthesia was needed. On the basis of this study, we suggest that the Er:YAG: laser can provide caries removal and cavity preparation in an adequate preparation time with minimal patient discomfort.

  10. A Systemic Review on Aloe arborescens Pharmacological Profile: Biological Activities and Pilot Clinical Trials.

    PubMed

    Singab, Abdel-Naser B; El-Hefnawy, Hala M; Esmat, Ahmed; Gad, Haidy A; Nazeam, Jilan A

    2015-12-01

    Since ancient times, plants and herbal preparations have been used as medicine. Research carried out in the last few decades has verified several such claims. Aloe arborescens Miller, belonging to the Aloe genus (Family Asphodelaceae), is one of the main varieties of Aloe used worldwide. The popularity of the plant in traditional medicine for several ailments (antitumor, immunomodulatory, antiinflammatory, antiulcer, antimicrobial and antifungal activity) focused the investigator's interest on this plant. Most importantly, the reported studies have shown the plant effectiveness on various cancer types such as liver, colon, duodenal, skin, pancreatic, intestinal, lung and kidney types. These multiple biological actions make Aloe an important resource for developing new natural therapies. However, the biological activities of isolated compounds such as glycoprotein, polysaccharides, enzyme and phenolics were insufficient. Considering all these, this contribution provides a systematic review outlining the evidence on the biological efficacy of the plant including the pharmacology and the related mechanisms of action, with specific attention to the various safety precautions, and preclinical and clinical studies, indicating the future research prospects of this plant.

  11. Prospective clinical study of press-ceramic overlap and full veneer restorations: 7-year results.

    PubMed

    Guess, Petra C; Selz, Christian F; Voulgarakis, Apostolos; Stampf, Susanne; Stappert, Christian F J

    2014-01-01

    The aim of this prospective clinical study was to investigate the long-term performance of all-ceramic veneers with overlap (OV) and full veneer (FV) preparation designs. Twenty-five patients were restored using 42 OV restorations (incisal/palatal butt-joint margin) and 24 FV restorations (palatal rounded shoulder margin). All restorations were leucite-reinforced glass-ceramic anterior veneers. The 7-year Kaplan-Meier survival rate was 100% for FV restorations and 97.6% for OV restorations. The all-ceramic veneers revealed significant deterioration over time according to United States Public Health Service criteria, irrespective of the preparation design. Based on the 7-year results of this study, both preparation designs can be considered reliable treatment options for anterior teeth with extended deficits.

  12. Prospective randomized clinical study of arterial pumps used for routine on pump coronary bypass grafting.

    PubMed

    Keyser, Andreas; Hilker, Michael K; Diez, Claudius; Philipp, Alois; Foltan, Maik; Schmid, Christof

    2011-05-01

    In a number of studies, centrifugal blood pumps--in comparison with roller pumps--have been shown to attenuate trauma to blood components. Nevertheless, the impact of these results on the postoperative course needs to be discussed controversially. In a prospective randomized study, 240 consecutive adult patients underwent elective myocardial revascularization with cardiopulmonary bypass employing five different pumps (Roller, Avecor, Sarns, Rotaflow, Bio-Medicus). We analyzed clinical course, blood loss, damage of blood components, and impairment of the hemostatic system. The study population was homogenous with respect to age, gender, myocardial function, and operative data. No differences were found with respect to time of ventilation, duration of intensive care stay, hospitalization, and laboratory data. The choice of arterial pump during standard extracorporeal bypass for elective coronary artery bypass grafting is no matter of concern.

  13. The MOTIV-HEART Study: A Prospective, Randomized, Single-Blind Pilot Study of Brief Strategic Therapy and Motivational Interviewing among Cardiac Rehabilitation Patients

    PubMed Central

    Pietrabissa, Giada; Manzoni, Gian Mauro; Rossi, Alessandro; Castelnuovo, Gianluca

    2017-01-01

    Background: Psychological distress, biomedical parameters, and unhealthy lifestyles contribute to a poorer prognosis for cardiac disease. Public health's challenge is to motivate patients to utilize self-care. Objective: This prospective, randomized, single-blind pilot study aimed at testing the incremental efficacy of Brief Strategic Therapy (BST) combined with Motivational Interviewing (MI) in improving selected biomedical and psychological outcomes over and beyond those of the stand-alone BST in a residential Cardiac Rehabilitation (CR) program. Method: Fourty-two inpatients (17 females), enrolled in a 1-month CR program, were randomly allocated into two conditions: (a) Three sessions of BST and (b) Three sessions of BST plus MI. Data were collected at baseline, discharge, and after 3 months through phone interviews. Results: At discharge, no significant between-group difference was found in any outcome variable. Changes from pre- to post-treatment within each condition showed significant improvements only in the BST group, where the level of external regulation diminished, and both the participants' self-regulation (Relative Autonomous Motivation Index, RAI) and willingness to change improved. At the 3-month follow-up, within-group analyses on responders (BST = 9; BST + MI = 11) showed a statistically significant improvement in the level of systolic blood pressure in both groups. Discussion: Findings showed no evidence of the incremental efficacy of combining BST and MI over and beyond BST alone on either selected biomedical or psychological outcomes among CR patients. Conclusions: Ends and limitations from the present pilot study should be considered and addressed in future investigations. PMID:28223950

  14. Development of an open metadata schema for prospective clinical research (openPCR) in China.

    PubMed

    Xu, W; Guan, Z; Sun, J; Wang, Z; Geng, Y

    2014-01-01

    In China, deployment of electronic data capture (EDC) and clinical data management system (CDMS) for clinical research (CR) is in its very early stage, and about 90% of clinical studies collected and submitted clinical data manually. This work aims to build an open metadata schema for Prospective Clinical Research (openPCR) in China based on openEHR archetypes, in order to help Chinese researchers easily create specific data entry templates for registration, study design and clinical data collection. Singapore Framework for Dublin Core Application Profiles (DCAP) is used to develop openPCR and four steps such as defining the core functional requirements and deducing the core metadata items, developing archetype models, defining metadata terms and creating archetype records, and finally developing implementation syntax are followed. The core functional requirements are divided into three categories: requirements for research registration, requirements for trial design, and requirements for case report form (CRF). 74 metadata items are identified and their Chinese authority names are created. The minimum metadata set of openPCR includes 3 documents, 6 sections, 26 top level data groups, 32 lower data groups and 74 data elements. The top level container in openPCR is composed of public document, internal document and clinical document archetypes. A hierarchical structure of openPCR is established according to Data Structure of Electronic Health Record Architecture and Data Standard of China (Chinese EHR Standard). Metadata attributes are grouped into six parts: identification, definition, representation, relation, usage guides, and administration. OpenPCR is an open metadata schema based on research registration standards, standards of the Clinical Data Interchange Standards Consortium (CDISC) and Chinese healthcare related standards, and is to be publicly available throughout China. It considers future integration of EHR and CR by adopting data structure and data

  15. Clinical Applications of Brain-Computer Interfaces: Current State and Future Prospects.

    PubMed

    Mak, Joseph N; Wolpaw, Jonathan R

    2009-01-01

    Brain-computer interfaces (BCIs) allow their users to communicate or control external devices using brain signals rather than the brain's normal output pathways of peripheral nerves and muscles. Motivated by the hope of restoring independence to severely disabled individuals and by interest in further extending human control of external systems, researchers from many fields are engaged in this challenging new work. BCI research and development have grown explosively over the past two decades. Efforts have recently begun to provide laboratory-validated BCI systems to severely disabled individuals for real-world applications. In this review, we discuss the current status and future prospects of BCI technology and its clinical applications. We will define BCI, review the BCI-relevant signals from the human brain, and describe the functional components of BCIs. We will also review current clinical applications of BCI technology, and identify potential users and potential applications. Finally, we will discuss current limitations of BCI technology, impediments to its widespread clinical use, and expectations for the future.

  16. Arthrocentesis and Temporomandibular Joint Disorders: Clinical and Radiological Results of a Prospective Study

    PubMed Central

    De Riu, Giacomo; Soma, Damiano; Pisano, Milena; Sembronio, Salvatore; Tullio, Antonio

    2013-01-01

    Purpose. We evaluated the efficacy of arthrocentesis in the treatment of temporomandibular joint (TMJ) disorders. Material and Methods. In this prospective clinical case series, 30 consecutive patients with TMJ disorders underwent arthrocentesis using saline and sodium hyaluronate injections. Outcome measures were TMJ pain, maximum mouth opening (MMO), joint noises, and anatomical changes in the TMJ architecture. Patients were evaluated using cone-beam computed tomography (CBCT) and magnetic resonance imaging (MRI) at the beginning of treatment and 60 days after the last arthrocentesis. Pretreatment and posttreatment clinical parameters were compared using paired and unpaired t-tests, and McNemar's test was used to evaluate CBCT and MRI changes (P < 0.05). Results. At 1-year follow-up examinations, visual analogue scale scores indicated that pain was reduced significantly and mean postoperative MMO was increased significantly. CBCT findings showed no significant change, and MRI showed only slight reductions in inflammatory signs. Conclusions. Within the limitations of this study, we can conclude that arthrocentesis is a simple, minimally invasive procedure with a relatively low risk of complications and significant clinical benefits in patients with TMJ disorders. This trial is registered with NCT01903512. PMID:24319462

  17. Clinical characteristics of well women seeking labial reduction surgery: a prospective study.

    PubMed

    Crouch, N S; Deans, R; Michala, L; Liao, L-M; Creighton, S M

    2011-11-01

    To assess clinical characteristics and expectations in well women requesting elective labial reduction surgery. Prospective study of women attending an outpatient gynaecology clinic. General gynaecology clinic at a Central London teaching hospital. Women requesting labial reduction surgery and referred by their general practitioner. The labia minora width and length were measured for all participants for comparison with published normal values. The presenting complaint was recorded, along with demographic details, expectations of surgery and sources of information regarding appearance of the labia. Labial measurements, reported symptoms and expectations of surgery. The labia of all participants were within normal published limits, with a mean (SD) of 26.9 (12.8) mm (right labia), and 24.8 (13.1) mm (left labia). The majority of complaints were regarding appearance or discomfort. Expectations were to alter the appearance with surgery. All women seeking surgery had normal-sized labia minora. Clear guidance is needed for clinicians on how best to care for the worried well woman seeking surgery. © 2011 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2011 RCOG.

  18. Auranofin versus penicillamine in rheumatoid arthritis. One-year results from a prospective clinical investigation.

    PubMed

    Manthorpe, R; Hørbov, S; Sylvest, J; Vinterberg, H

    1986-01-01

    Forty patients with definite or classical active rheumatoid arthritis were stratified by the minimization procedure to auranofin (6 mg/day) or penicillamine (go slow and low regime). This investigation is a prospective planned 3 year patient and 'doctor-open' as well as 'doctor-blind' clinical trial. This article describes the results after 12 months. Both drugs decreased disease activity and improved the functional capacity in a similar way. Two patients in the auranofin group and 5 in the penicillamine group stopped treatment due to major side effects. Four other patients in the auranofin group left treatment: 2 due to death from unrelated cause and 2 according to the Helsinki II Declaration. After one year a further patient in the auranofin group and 2 in the penicillamine group stopped treatment due to lack of clinical effect. Side effects due to auranofin were statistically more frequent distal in the gastrointestinal tract (loose stools/diarrhoea) than with penicillamine. In contrast, penicillamine produced significantly more side effects in the oral cavity (mainly taste disturbances) than auranofin. Other side effects were about equal in the two groups, but 2 cases of severe proteinuria and one with obstructive lung disease were observed in the penicillamine group. Only 3 patients did not complain of any untoward effect during the 12-month period. We conclude that on the basis of this one year investigation it is an open question whether one should select auranofin or penicillamine for the treatment of clinical active rheumatoid arthritis.

  19. Prospective registration and results disclosure of clinical trials in the Americas: a roadmap toward transparency.

    PubMed

    Krleža-Jeriç, Karmela; Lemmens, Trudo; Reveiz, Ludovic; Cuervo, Luis Gabriel; Bero, Lisa Anne

    2011-07-01

    The objective of this article is to propose a roadmap toward transparency of clinical trials in the Americas by their prospective registration and results disclosure. This will broaden access to more complete and accurate data and facilitate evidence-informed decision-making and participation in research. Consequently, it should have a positive impact on people's health and should promote trust in health research. Existing initiatives were identified, registration of trials was analyzed following the World Health Organization (WHO) standards on trial registration, and a roadmap is proposed to address the gaps in advancing transparency. The analysis shows that, in spite of numerous regional and country initiatives, clinical trials taking place in nonEnglish-speaking parts of the Americas are underregistered. A roadmap is proposed to enhance research governance and good research practice by improving the transparency of clinical trials. The proposed roadmap includes strategies for implementing WHO international standards for trial registration, for developing international standards of public disclosure of trial results, and for a potential role of the Pan American Health Organization.

  20. Prospective clinical observational study evaluating gender-associated differences of preoperative pain intensity

    PubMed Central

    Tafelski, Sascha; Kerper, Léonie F; Salz, Anna-Lena; Spies, Claudia; Reuter, Eva; Nachtigall, Irit; Schäfer, Michael; Krannich, Alexander; Krampe, Henning

    2016-01-01

    Abstract Previous studies reported conflicting results concerning different pain perceptions of men and women. Recent research found higher pain levels in men after major surgery, contrasted by women after minor procedures. This trial investigates differences in self-reported preoperative pain intensity between genders before surgery. Patients were enrolled in 2011 and 2012 presenting for preoperative evaluation at the anesthesiological assessment clinic at Charité University hospital. Out of 5102 patients completing a computer-assisted self-assessment, 3042 surgical patients with any preoperative pain were included into this prospective observational clinical study. Preoperative pain intensity (0–100 VAS, visual analog scale) was evaluated integrating psychological cofactors into analysis. Women reported higher preoperative pain intensity than men with median VAS scores of 30 (25th–75th percentiles: 10–52) versus 21 (10–46) (P < 0.001). Adjusted multiple regression analysis showed that female gender remained statistically significantly associated with higher pain intensity (P < 0.001). Gender differences were consistent across several subgroups especially with varying patterns in elderly. Women scheduled for minor and moderate surgical procedures showed largest differences in overall pain compared to men. This large clinical study observed significantly higher preoperative pain intensity in female surgical patients. This gender difference was larger in the elderly potentially contradicting the current hypothesis of a primary sex-hormone derived effect. The observed variability in specific patient subgroups may help to explain heterogeneous findings of previous studies. PMID:27399095

  1. Prospective Evaluation of a Clinical Practice Guideline for Diagnosis of Appendicitis in Children

    PubMed Central

    Santillanes, Genevieve; Simms, Sonia; Gausche-Hill, Marianne; Diament, Michael; Putnam, Brant; Renslo, Richard; Lee, Jumie; Tinger, Elga; Lewis, Roger J.

    2015-01-01

    Objectives The objective was to assess the performance of a clinical practice guideline for evaluation of possible appendicitis in children. The guideline incorporated risk stratification, staged imaging, and early surgical involvement in high-risk cases. Methods The authors prospectively evaluated the clinical guideline in one pediatric emergency department (ED) in a general teaching hospital. Patients were risk-stratified based on history, physical examination findings, and laboratory results. Imaging was ordered selectively based on risk category, with ultrasound (US) as the initial imaging modality. Computed tomography (CT) was ordered if the US was negative or indeterminate. Surgery was consulted before imaging in high-risk patients. Results A total of 475 patients were enrolled. Of those, 193 (41%) had appendicitis. No low-risk patient had appendicitis. Medium-risk patients had a 19% rate of appendicitis, and 83% of high-risk patients had appendicitis. Factors associated with an increased likelihood of appendicitis included decreased bowel sounds; rebound tenderness; and presence of psoas, obturator, or Rovsing’s signs. Of the 475 patients, 276 (58%) were managed without a CT scan. Seventy-one of the 193 (37%) patients with appendicitis went to the operating room without any imaging. The rate of missed appendicitis was 2%, and the rate of negative appendectomy was 1%. Conclusions The clinical practice guideline performed well in a general teaching hospital. Rates of negative appendectomy and missed appendicitis were low and 58% of patients were managed without a CT scan. PMID:22849662

  2. A three-year prospective study of adult subjects with gingivitis. I: clinical periodontal parameters.

    PubMed

    Bogren, Anna; Teles, Ricardo; Torresyap, Gay; Haffajee, Anne D; Socransky, Sigmund S; Lindhe, Jan; Wennström, Jan L

    2007-01-01

    The objective of this study was to monitor prospectively clinical parameters in subjects without signs of destructive periodontal disease who were involved in a primary prevention programme, and to determine the changes that occurred between yearly examinations over a 3-year period. One hundred and twenty-six subjects aged at least 20 years with a maximum of two tooth sites with probing pocket depth (PPD)>4 mm and no proximal sites with clinical attachment loss participated in the study. Primary prevention was provided at baseline of the study and then every 6 months. Plaque, bleeding on probing (BoP) and PPD were scored at baseline, 1, 2 and 3 years. There were no significant changes in the plaque score over the 3 years. After year 1, the BoP score was significantly improved with 5.6%, while no further improvement in BoP was found at years 2 and 3. The mean PPD decreased from 2.3 to 2.1 mm over the 3 years (p<0.05). Although some individuals exhibiting minor signs of periodontal pathology may have benefited from the primary prevention, the overall clinical improvement was limited for such subjects in the present 3-year study.

  3. Clinical application of SNP array analysis in first-trimester pregnancy loss: a prospective study.

    PubMed

    Wang, Y; Cheng, Q; Meng, L; Luo, C; Hu, H; Zhang, J; Cheng, J; Xu, T; Jiang, T; Liang, D; Hu, P; Xu, Z

    2017-06-01

    Chromosomal microarray analysis (CMA) has been used routinely in pediatric and prenatal genetic diagnosis in clinical practice, but it has rarely been applied to miscarriage analysis. In this study, we conducted a prospective study to evaluate the feasibility of CMA for genetic diagnosis of first-trimester miscarriage specimens. We successfully analyzed 551 fresh miscarriage specimens using single-nucleotide polymorphism (SNP) array. Among the specimens, 2.9% (16/551) had significant maternal cell contamination and were excluded from the study. Clinically significant chromosomal abnormalities were identified in 295 (55.1%) cases, including 214 (40%) with aneuploidy, 40 (7.5%) with polyploidy, 19 (3.6%) with partial aneuploidy, 12 (2.2%) with pathogenic microdeletion/microduplication, and 10 (1.9%) with uniparental isodisomy (isoUPD). Variants of uncertain significance were obtained in 15 cases (2.8%). Notably, isoUPD involving a single chromosome (chromosome 22) and two recurrent copy number variations, 22q11.2 microdeletion and 7q11.23 microdeletion, were identified as probably to be associated with miscarriage. The frequency and distribution of genetic aberrations in the spontaneous abortion group was not significantly different from those in the recurrent miscarriage group. Our study suggests SNP array is a reliable, robust, and high-resolution technology for genetic diagnosis of miscarriage in clinical practice. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  4. Acute toluene intoxication--clinical presentation, management and prognosis: a prospective observational study.

    PubMed

    Camara-Lemarroy, Carlos Rodrigo; Rodríguez-Gutiérrez, René; Monreal-Robles, Roberto; González-González, José Gerardo

    2015-08-18

    Toluene is one of the most widely abused inhaled drugs due to its acute neurologic effects including euphoria and subsequent depression. However, dangerous metabolic abnormalities are associated to acute toluene intoxication. It has been previously reported that rhabdomyolysis and acute hepatorenal injury could be hallmarks of the condition, and could constitute risk factors for poor outcomes. The objective was to describe the clinical presentation, to characterize the renal and liver abnormalities, the management and prognosis associated to acute toluene intoxication. We prospectively assessed 20 patients that were admitted to a single center's emergency department from September 2012 to June 2014 with clinical and metabolic alterations due to acute toluene intoxication. The main clinical presentation consisted of weakness associated to severe hypokalemia and acidosis. Renal glomerular injury (proteinuria) is ubiquitous. Biliary tract injury (alkaline phosphatase and gamma-glutamyl transpeptidase elevations) disproportional to hepatocellular injury is common. Rhabdomyolysis occurred in 80% of patients, probably due to hypokalemia and hypophosphatemia. There were three deaths, all female, and all associated with altered mental status, severe acidosis, hypokalemia and acute oliguric renal failure. The cause of death was in all cases due to cardiac rhythm abnormalities. The hallmarks of acute toluene intoxication are hypokalemic paralysis and metabolic acidosis. Liver injury and rhabdomyolysis are common. On admission, altered mental status, renal failure, severe acidemia and female gender (not significant in our study, but present in all three deaths) could be associated with a poor outcome, and patients with these characteristics should be considered to be treated in an intensive care unit.

  5. [Rivaroxaban at Non-Valvular Atrial Fibrillation: a Prospective Study and Clinical Practice].

    PubMed

    Fonyakin, A V

    2016-08-01

    The article presents an analytical review of the results of post-registration clinical studies on the efficacy and safety of rivaroxaban in nonvalvular atrial fibrillation (AF) to prevent stroke and other systemic thromboembolic complications. The main purpose of the first large prospective international observational study of rivaroxaban for stroke prevention in patients with non-valvular AF patients XANTUS was the analysis of efficacy and safety of rivaroxaban in clinical practice. Results of one year of observation of 6784 patients confirmed that rivaroxaban is effective and safe in real unselected population of patients with non-valvular AF and various stroke risk. The first Russian multicenter observational study Neuro-Xar dedicated to secondary prevention of stroke and systemic embolism, demonstrated the efficacy and safety of rivaroxaban in routine clinical practice. Lower risk of fatal intracranial and gastrointestinal bleeding was found in retrospective post-marketing studies, of rivaroxaban in the US, such as the PMSS and REVISIT-US. Rivaroxaban therapy was associated with reduced risk of the combined endpoint (ischemic stroke and intracranial hemorrhage).

  6. A prospective evaluation of zirconia anterior partial fixed dental prostheses: Clinical results after seven years.

    PubMed

    Solá-Ruíz, Maria Fernanda; Agustin-Panadero, Rubén; Fons-Font, Antonio; Labaig-Rueda, Carlos

    2015-06-01

    Because of the high mechanical strength of zirconium dioxide, the metal in fixed partial prostheses can now be replaced. However, the material is susceptible to aging or hydrothermal degradation and to chipping of the feldspathic veneer. The purpose of this prospective study was to evaluate the survival (without failure) and success (survival without any complication or failure) rate and clinical efficacy of anterior zirconia partial fixed dental prostheses. Twenty-seven anterior partial fixed dental prostheses of 3 to 6 units were fabricated. All participants were examined after 1 month and 6 months, then annually for 7 years. Three partial fixed dental prostheses failed and had to be removed: 2 because of secondary caries, which increased failure significantly (P=.001) and 1 because of severe chipping. Six partial fixed dental prostheses had complications: 2 debonded, 3 had chipping, and 1 had periapical pathology. All veneer porcelain fractures occurred in 6-unit fixed partial prostheses (P=.002). The clinical success rate was 88.8% after the 7-year follow-up. The clinical behavior of partial fixed dental prostheses with a zirconium dioxide core in the anterior region provides an adequate medium-term survival rate. The main cause of failure was secondary caries. The most frequent complication was chipping, which was directly related to the number of units of the prosthesis. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  7. Arthrocentesis and temporomandibular joint disorders: clinical and radiological results of a prospective study.

    PubMed

    De Riu, Giacomo; Stimolo, Mirella; Meloni, Silvio Mario; Soma, Damiano; Pisano, Milena; Sembronio, Salvatore; Tullio, Antonio

    2013-01-01

    Purpose. We evaluated the efficacy of arthrocentesis in the treatment of temporomandibular joint (TMJ) disorders. Material and Methods. In this prospective clinical case series, 30 consecutive patients with TMJ disorders underwent arthrocentesis using saline and sodium hyaluronate injections. Outcome measures were TMJ pain, maximum mouth opening (MMO), joint noises, and anatomical changes in the TMJ architecture. Patients were evaluated using cone-beam computed tomography (CBCT) and magnetic resonance imaging (MRI) at the beginning of treatment and 60 days after the last arthrocentesis. Pretreatment and posttreatment clinical parameters were compared using paired and unpaired t-tests, and McNemar's test was used to evaluate CBCT and MRI changes (P < 0.05). Results. At 1-year follow-up examinations, visual analogue scale scores indicated that pain was reduced significantly and mean postoperative MMO was increased significantly. CBCT findings showed no significant change, and MRI showed only slight reductions in inflammatory signs. Conclusions. Within the limitations of this study, we can conclude that arthrocentesis is a simple, minimally invasive procedure with a relatively low risk of complications and significant clinical benefits in patients with TMJ disorders. This trial is registered with NCT01903512.

  8. Discrepancies Between Clinical Diagnoses and Autopsy Findings in Critically Ill Children: A Prospective Study.

    PubMed

    Carlotti, Ana P C P; Bachette, Letícia G; Carmona, Fabio; Manso, Paulo H; Vicente, Walter V A; Ramalho, Fernando S

    2016-12-01

    To evaluate the discrepancies between clinical and autopsy diagnoses in patients who died in the pediatric intensive care units (PICUs) of a tertiary care university hospital. A prospective study of all consecutive autopsies discussed at monthly mortality conferences over 5 years. Discrepancies between premortem and autopsy diagnoses were classified according to modified Goldman et al criteria. From January 1, 2011, to December 31, 2015, a total of 2,679 children were admitted to the two PICUs of our hospital; 257 (9.6%) died, 150 (58.4%) underwent autopsy, and 123 were included. Complete concordance between clinical and postmortem diagnoses was observed in 86 (69.9%) patients; 20 (16.3%) had a class I discrepancy, and eight (6.5%) had a class II discrepancy. Comparing 2011 and 2015, the rate of major discrepancies decreased from 31.6% to 15%. Our results emphasize the importance of autopsy to clarify the cause of death and its potential contribution to improvement of team performance and quality of care. © American Society for Clinical Pathology, 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  9. Inhaled PGE1 in neonates with hypoxemic respiratory failure: two pilot feasibility randomized clinical trials.

    PubMed

    Sood, Beena G; Keszler, Martin; Garg, Meena; Klein, Jonathan M; Ohls, Robin; Ambalavanan, Namasivayam; Cotten, C Michael; Malian, Monica; Sanchez, Pablo J; Lakshminrusimha, Satyan; Nelin, Leif D; Van Meurs, Krisa P; Bara, Rebecca; Saha, Shampa; Das, Abhik; Wallace, Dennis; Higgins, Rosemary D; Shankaran, Seetha

    2014-12-12

    Inhaled nitric oxide (INO), a selective pulmonary vasodilator, has revolutionized the treatment of neonatal hypoxemic respiratory failure (NHRF). However, there is lack of sustained improvement in 30 to 46% of infants. Aerosolized prostaglandins I2 (PGI2) and E1 (PGE1) have been reported to be effective selective pulmonary vasodilators. The objective of this study was to evaluate the feasibility of a randomized controlled trial (RCT) of inhaled PGE1 (IPGE1) in NHRF. Two pilot multicenter phase II RCTs are included in this report. In the first pilot, late preterm and term neonates with NHRF, who had an oxygenation index (OI) of ≥15 and <25 on two arterial blood gases and had not previously received INO, were randomly assigned to receive two doses of IPGE1 (300 and 150 ng/kg/min) or placebo. The primary outcome was the enrollment of 50 infants in six to nine months at 10 sites. The first pilot was halted after four months for failure to enroll a single infant. The most common cause for non-enrollment was prior initiation of INO. In a re-designed second pilot, co-administration of IPGE1 and INO was permitted. Infants with suboptimal response to INO received either aerosolized saline or IPGE1 at a low (150 ng/kg/min) or high dose (300 ng/kg/min) for a maximum duration of 72 hours. The primary outcome was the recruitment of an adequate number of patients (n = 50) in a nine-month-period, with fewer than 20% protocol violations. No infants were enrolled in the first pilot. Seven patients were enrolled in the second pilot; three in the control, two in the low-dose IPGE1, and two in the high-dose IPGE1 groups. The study was halted for recruitment futility after approximately six months as enrollment targets were not met. No serious adverse events, one minor protocol deviation and one pharmacy protocol violation were reported. These two pilot RCTs failed to recruit adequate eligible newborns with NHRF. Complex management RCTs of novel therapies for persistent pulmonary

  10. Medical students as teachers at CoSMO, Columbia University's student-run clinic: a pilot study and literature review.

    PubMed

    Hamso, Magni; Ramsdell, Amanda; Balmer, Dorene; Boquin, Cyrus

    2012-01-01

    Although medical students are expected to teach as soon as they begin residency, medical schools have just recently begun adding teacher training to their curricula. Student-run clinics (SRCs) may provide opportunities in clinical teaching before residency. The aim of this pilot study was to examine students' experiences in clinical teaching at Columbia Student Medical Outreach (CoSMO), Columbia University's SRC, during the 2009-2010 school year. A mixed-methods approach was used. Data included closed and open-ended surveys (n = 34), combined interviews with preclinical and clinical student pairs (n = 5), individual interviews (n = 10), and focus groups (n = 3). The transcripts were analyzed using the principles of grounded theory. Many students had their first clinical teaching experience while volunteering at CoSMO. Clinical students' ability to teach affected the quality of the learning experience for their preclinical peers. Preclinical students who asked questions and engaged in patient care challenged their clinical peers to balance teaching with patient care. Clinical students began to see themselves as teachers while volunteering at CoSMO. The practical experiences in clinical teaching that students have at SRCs can supplement classroom-based trainings. Medical schools might revisit their SRCs as places for exposure to clinical teaching.

  11. Subscapularis tendon tear classification based on 3-dimensional anatomic footprint: a cadaveric and prospective clinical observational study.

    PubMed

    Yoo, Jae Chul; Rhee, Yong Girl; Shin, Sang Jin; Park, Yong Bok; McGarry, Michelle H; Jun, Bong Jae; Lee, Thay Q

    2015-01-01

    The purpose of this study was to define the subscapularis tendon footprint anatomy in 3-dimensional (3D) perspective, report the incidence of tears, and classify the tear patterns prospectively during shoulder arthroscopic surgery. The cadaveric study consisted of a pilot study that revealed 4 different bony facets by simple observation at the subscapularis attachment. The 3D footprint anatomy was digitally evaluated in 39 cadavers. The clinical study was conducted from 2011 to 2013 and was based on 3D footprint anatomy. All consecutive arthroscopic shoulder operations were prospectively evaluated for subscapularis tendon integrity. A new classification system was developed with 5 categories: (1) type I-fraying or longitudinal split of the subscapularis tendon leading edge; (2) type IIA-less than 50% subscapularis tendon detachment of the first facet; (3) type IIB-greater than 50% detachment without complete disruption of the lateral hood, which is approximately a one-quarter to one-third tear of the entire subscapularis tendon's superior-inferior length; (5) type III-entire first facet with complete-thickness tear (lateral hood tear), (5) type IV-first and second facets are exposed with much medial retraction of the tendon (approximately a two-thirds tear of the entire footprint; entire tendinous portion), and (6) type V-complete subscapularis tendon involving the muscular portion (rare). The medial-lateral and superior-inferior dimensions of the first facet dimensions were 13.8 × 13.5 mm, respectively; its surface area was 34% of the entire footprint. From superior to inferior, the facet's medial-lateral dimensions and surface area decreased. The fourth facet was 77 mm(2) from medial to lateral and encompassed 15% of the footprint. Clinically, among 821 shoulder arthroscopies performed over a 29-month-period, the incidence of subscapularis tears was 415 (50.5%). The most common tear was type IIB (29.4%) or a one-quarter to one-third tear of the entire

  12. Clinical Impact of Gadoxetic Acid-Enhanced Magnetic Resonance Imaging on Hepatoma Management: A Prospective Study.

    PubMed

    Wang, Jing-Houng; Chen, Tai-Yi; Ou, Hsin-You; Wang, Chih-Chi; Liu, Yueh-Wei; Hung, Chao-Hung; Chen, Chien-Hung; Kuo, Chung-Huang; Hu, Tsung-Hui; Cheng, Yu-Fan; Lu, Sheng-Nan

    2016-04-01

    For patients with hepatocellular carcinoma (HCC), gadoxetic acid-enhanced magnetic resonance imaging (EOB-MRI) improved the diagnosis, migrated Barcelona Clinic Liver Cancer (BCLC) stage, and changed therapeutic decision in retrospective analysis. This prospective study was to evaluate the clinical impact of EOB-MRI on HCC management. From September 2012 to February 2014, consecutive patients with suspicion of HCC in BCLC early stage by multidetector computed tomography or dynamic MRI with non-specific gadolinium, well liver function reserve, and admitted for resection evaluation were enrolled prospectively. Additional EOB-MRI was performed. The HCC diagnosis, BCLC staging, and treatment decision were obtained in a liver cancer conference. EOB-MRI impact on HCC management was analyzed. One hundred and three patients including 68 with typical and 35 with atypical HCC nodules in dynamic imaging studies were enrolled. EOB-MRI characterized 3 (4.4 %) benign and 33 (94.3 %) HCC for patients with typical and atypical HCC nodules, respectively. For 90 HCC patients, additional EOB-MRI changed BCLC stage in 25 (27.8 %) and treatment decision in 17 (18.9 %) patients. There were 66 patients with 78 resected nodules including 65 HCCs, 4 intrahepatic cholangiocarcinomas, and 9 benign nodules. Dynamic study and EOB-MRI detected and characterized 69 and 77 nodules, respectively. The sensitivity and accuracy in HCC diagnosis were 98.5 and 85.7 % for EOB-MRI, which were better than those of dynamic study (p < 0.001). Additional EOB-MRI improved HCC diagnosis in sensitivity, accuracy but not specificity. It changed BCLC staging and treatment decision in 27.8 and 18.9 % of early-stage HCC patients.

  13. Mono- versus polyaxial locking plates in distal femur fractures: a prospective randomized multicentre clinical trial.

    PubMed

    Hanschen, Marc; Aschenbrenner, Ina M; Fehske, Kai; Kirchhoff, Sonja; Keil, Leonhard; Holzapfel, Boris M; Winkler, Sebastian; Fuechtmeier, Bernd; Neugebauer, Rainer; Luehrs, Sven; Liener, Ulrich; Biberthaler, Peter

    2014-04-01

    Treatment of complex fractures of the distal femur utilizing monoaxial locking plates (e.g. Less Invasive Stabilisation System, LISS®, Synthes) is considered to be superior to conventional plating systems. Due to the limitation that the thread forces the screw into pre-determined positions, modifications have been made to allow screw positioning within a range of 30° (Non Contact Bridging, NCB®-DF, Zimmer). For the first time, this multicenter prospective randomized clinical trial (RCT) investigates the outcome of LISS® vs. NCB®-DF treatment following complex fractures of the distal femur. Since June 2008, 27 patients with a fracture of the distal femur (AO ASIF 33-A-C and periprosthetic fractures) were enrolled in this study by four university trauma centres in southern Germany. Clinical (e.g. range of motion, Oxford knee score, Tegner score) and radiological (e.g. axis deviation, secondary loss of realignment) follow-ups were conducted one and six weeks, as well as three, six, and 12 months after the operation. This study comprises data of 27 patients (8 male, 19 female; 15 NCB®-DF, 12 LISS®). Polyaxial osteosynthesis using the NCB® system tended to result in better functional knee scores and a higher range of motion. Interestingly, fracture union tended to be more rapid using the polyaxial plating system. We present the analysis of a multicenter prospective RCT to compare the monoaxial LISS® vs. the polyaxial NCB®-DF treatment following complex fractures of the distal femur. NCB®-DF treatment tended to result in better functional and radiological outcomes than LISS® treatment. Level I.

  14. Clinical progression and outcome of dysphagia following thermal burn injury: a prospective cohort study.

    PubMed

    Rumbach, Anna F; Ward, Elizabeth C; Cornwell, Petrea L; Bassett, Lynell V; Muller, Michael J

    2012-01-01

    The objectives of this study were 1) to establish clinical profiles of dysphagic and nondysphagic individuals following thermal burn injury and 2) to provide a clinical profile of the progression and outcome of dysphagia resolution by hospital discharge for a dysphagic cohort. A total of 438 consecutively admitted patients with thermal burns were included. All patients underwent a clinical swallowing examination. Medical parameters regarding burn presentation and its treatment and speech-language pathology specific variables from admission to discharge were collected for each participant. Dysphagia was identified in 49 patients via clinical assessment, and their course of recovery was followed up until the point of dysphagia resolution or discharge. No significant difference was observed between the dysphagic and nondysphagic groups in age, gender, and injury etiology. However, the dysphagic cohort was significantly different from the nondysphagic group in all variables pertaining to injury presentation and medical management. Individuals with dysphagia took significantly longer to start, and maintain, oral intake and required nonoral supplementation for three and a half times longer than those who were nondysphagic. Length of speech-language pathology intervention averaged 1 month for the dysphagics and increased with dysphagia severity. Return to normal fluid consistencies occurred in >75% of dysphagic individuals by week 7 after injury, although resumption of normal diet textures was more protracted, with 75% resuming normal oral intake by week 9. Dysphagia had resolved in 50% of the cohort by week 6, and by hospital discharge, 85% of the dysphagic individuals had resumed normal oral intake of thin fluids and a general diet. This is the first large prospective cohort study to establish clinical profiles of dysphagic and nondysphagic cohorts and document the nature of dysphagia and patterns of recovery within the thermal burn population. These current data will

  15. A prospective study of neuropathic pain induced by thoracotomy: incidence, clinical description, and diagnosis.

    PubMed

    Guastella, Virginie; Mick, Gérard; Soriano, Christophe; Vallet, Laurent; Escande, Georges; Dubray, Claude; Eschalier, Alain

    2011-01-01

    This study evaluated prospectively the incidence of neuropathic pain after thoracotomy, described its clinical characteristics, and delineated landmarks for its diagnosis in daily practice. We evaluated clinically painful symptoms and sensory deficits in 54 patients after lateral/posterolateral thoracotomy for broncho-pulmonary carcinoma with standardized surgical and analgesic procedures. At 2months, 49 patients suffered from non malignant thoracic pain, and at 6months 38 patients (loss to follow-up for 7) reported persisting pain. In 35 patients, painful symptoms and sensory deficits could be evaluated using a standardized clinical bedside procedure. According to the grading system proposed by Treede et al. [41], neuropathic pain was considered probable in 21 patients, while use of the DN4 questionnaire concluded that neuropathic pain was probable in 17 patients. The two diagnostic procedures provided similar conclusions in 16 patients. Morphine consumption during the early post-operative period (mean 111.3±30.8mg/day) and pain intensity (VAS: mean 5.71±2.1) were significantly higher in patients suffering from neuropathic pain than in other patients with pain (mean 80±21.4mg/day; VAS: mean 3.9±2.4). The clinical picture in most patients with neuropathic pain included electric shocks and severe multimodal hypoesthesia in the sensory area of 5th/6th intercostal nerves. Thus, our results indicate a minimal incidence of chronic post-thoracotomy pain at 70% and that of neuropathic pain at 29%, this latter being clinically suggested by a combination of certain symptoms and reinforced by the DN4 questionnaire when sensory deficit at scar is present.

  16. Affective Dysregulation and Reality Distortion: A 10-Year Prospective Study of Their Association and Clinical Relevance

    PubMed Central

    van Rossum, Inge; Dominguez, Maria-de-Gracia; Lieb, Roselind; Wittchen, Hans-Ulrich; van Os, Jim

    2011-01-01

    Evidence from clinical patient populations indicates that affective dysregulation is strongly associated with reality distortion, suggesting that a process of misassignment of emotional salience may underlie this connection. To examine this in more detail without clinical confounds, affective regulation-reality distortion relationships, and their clinical relevance, were examined in a German prospective cohort community study. A cohort of 2524 adolescents and young adults aged 14–24 years at baseline was examined by experienced psychologists. Presence of psychotic experiences and (hypo)manic and depressive symptoms was assessed at 2 time points (3.5 and up to 10 years after baseline) using the Munich-Composite International Diagnostic Interview. Associations were tested between level of affective dysregulation on the one hand and incidence of psychotic experiences, persistence of these experiences, and psychotic Impairment on the other. Most psychotic experiences occurred in a context of affective dysregulation, and bidirectional dose-response was apparent with greater level of both affective dysregulation and psychotic experiences. Persistence of psychotic experiences was progressively more likely with greater level of (hypo)manic symptoms (odds ratio [OR] trend = 1.51, P < .001) and depressive symptoms (OR trend = 1.15, P = .012). Similarly, psychotic experiences of clinical relevance were progressively more likely to occur with greater level of affective dysregulation (depressive symptoms: OR trend = 1.28, P = .002; (hypo)manic symptoms: OR trend = 1.37, P = .036). Correlated genetic liabilities underlying affective and nonaffective psychotic syndromes may be expressed as correlated dimensions in the general population. Also, affective dysregulation may contribute causally to the persistence and clinical relevance of reality distortion, possibly by facilitating a mechanism of aberrant salience attribution. PMID:19793794

  17. Clinical Validation of Therapeutic Drug Monitoring of Imipenem in Spent Effluent in Critically Ill Patients Receiving Continuous Renal Replacement Therapy: A Pilot Study

    PubMed Central

    Wen, Aiping; Li, Zhe; Yu, Junxian; Li, Ren; Cheng, Sheng; Duan, Meili; Bai, Jing

    2016-01-01

    Objectives The primary objective of this pilot study was to investigate whether the therapeutic drug monitoring of imipenem could be performed with spent effluent instead of blood sampling collected from critically ill patients under continuous renal replacement therapy. Methods A prospective open-label study was conducted in a real clinical setting. Both blood and effluent samples were collected pairwise before imipenem administration and 0.5, 1, 1.5, 2, 3, 4, 6, and 8 h after imipenem administration. Plasma and effluent imipenem concentrations were determined by reversed-phase high-performance liquid chromatography with ultraviolet detection. Pharmacokinetic and pharmacodynamic parameters of blood and effluent samples were calculated. Results Eighty-three paired plasma and effluent samples were obtained from 10 patients. The Pearson correlation coefficient of the imipenem concentrations in plasma and effluent was 0.950 (P<0.0001). The average plasma-to-effluent imipenem concentration ratio was 1.044 (95% confidence interval, 0.975 to 1.114) with Bland-Altman analysis. No statistically significant difference was found in the pharmacokinetic and pharmacodynamic parameters tested in paired plasma and effluent samples with Wilcoxon test. Conclusion Spent effluent of continuous renal replacement therapy could be used for therapeutic drug monitoring of imipenem instead of blood sampling in critically ill patients. PMID:27093294

  18. Clinical-Genetic Associations in the Prospective Huntington at Risk Observational Study (PHAROS): Implications for Clinical Trials.

    PubMed

    Biglan, Kevin Michael; Shoulson, Ira; Kieburtz, Karl; Oakes, David; Kayson, Elise; Shinaman, M Aileen; Zhao, Hongwei; Romer, Megan; Young, Anne; Hersch, Steven; Penney, Jack; Marder, Karen; Paulsen, Jane; Quaid, Kimberly; Siemers, Eric; Tanner, Caroline; Mallonee, William; Suter, Greg; Dubinsky, Richard; Gray, Carolyn; Nance, Martha; Bundlie, Scott; Radtke, Dawn; Kostyk, Sandra; Baic, Corrine; Caress, James; Walker, Francis; Hunt, Victoria; O'Neill, Christine; Chouinard, Sylvain; Factor, Stewart; Greenamyre, Timothy; Wood-Siverio, Cathy; Corey-Bloom, Jody; Song, David; Peavy, Guerry; Moskowitz, Carol; Wesson, Melissa; Samii, Ali; Bird, Thomas; Lipe, Hillary; Blindauer, Karen; Marshall, Frederick; Zimmerman, Carol; Goldstein, Jody; Rosas, Diana; Novak, Peter; Caviness, John; Adler, Charles; Duffy, Amy; Wheelock, Vicki; Tempkin, Teresa; Richman, David; Seeberger, Lauren; Albin, Roger; Chou, Kelvin L; Racette, Brad; Perlmutter, Joel S; Perlman, Susan; Bordelon, Yvette; Martin, Wayne; Wieler, Marguerite; Leavitt, Blair; Raymond, Lynn; Decolongon, Joji; Clarke, Lorne; Jankovic, Joseph; Hunter, Christine; Hauser, Robert A; Sanchez-Ramos, Juan; Furtado, Sarah; Suchowersky, Oksana; Klimek, Mary Lou; Guttman, Mark; Sethna, Rustom; Feigin, Andrew; Cox, Marie; Shannon, Barbara; Percy, Alan; Dure, Leon; Harrison, Madaline; Johnson, William; Higgins, Donald; Molho, Eric; Nickerson, Constance; Evans, Sharon; Hobson, Douglas; Singer, Carlos; Galvez-Jimenez, Nestor; Shannon, Kathleen; Comella, Cynthia; Ross, Christopher; Saint-Hilaire, Marie H; Testa, Claudia; Rosenblatt, Adam; Hogarth, Penelope; Weiner, William; Como, Peter; Kumar, Rajeev; Cotto, Candace; Stout, Julie; Brocht, Alicia; Watts, Arthur; Eberly, Shirley; Weaver, Christine; Foroud, Tatiana; Gusella, James; MacDonald, Marcy; Myers, Richard; Fahn, Stanley; Shults, Clifford

    2016-01-01

    Identifying measures that are associated with the cytosine-adenine-guanine (CAG) expansion in individuals before diagnosis of Huntington disease (HD) has implications for designing clinical trials. To identify the earliest features associated with the motor diagnosis of HD in the Prospective Huntington at Risk Observational Study (PHAROS). A prospective, multicenter, longitudinal cohort study was conducted at 43 US and Canadian Huntington Study Group research sites from July 9, 1999, through December 17, 2009. Participants included 983 unaffected adults at risk for HD who had chosen to remain unaware of their mutation status. Baseline comparability between CAG expansion (≥37 repeats) and nonexpansion (<37 repeats) groups was assessed. All participants and investigators were blinded to individual CAG analysis. A repeated-measures analysis adjusting for age and sex was used to assess the divergence of the linear trend between the expanded and nonexpanded groups. Data were analyzed from April 27, 2010, to September 3, 2013. Huntington disease mutation status in individuals with CAG expansion vs without CAG expansion. Unified Huntington's Disease Rating Scale motor (score range, 0-124; higher scores indicate greater impairment), cognitive (symbol digits modality is the total number of correct responses in 90 seconds; lower scores indicate greater impairment), behavioral (score range, 0-176; higher scores indicate greater behavioral symptoms), and functional (Total Functional Capacity score range, 0-13; lower scores indicate reduced functional ability) domains were assessed at baseline and every 9 months up to a maximum of 10 years. Among the 983 research participants at risk for HD in the longitudinal cohort, 345 (35.1%) carried the CAG expansion and 638 (64.9%) did not. The mean (SD) duration of follow-up was 5.8 (3.0) years. At baseline, participants with expansions had more impaired motor (3.0 [4.2] vs 1.9 [2.8]; P < .001), cognitive (P < .05 for all

  19. Efficacy, Safety, and Predictors of Intradiscal Methylene Blue Injection for Discogenic Low Back Pain: Results of a Multicenter Prospective Clinical Series.

    PubMed

    Kallewaard, Jan Willem; Geurts, José W; Kessels, Alphons; Willems, Paul; van Santbrink, Henk; van Kleef, Maarten

    2016-04-01

    Prospective clinical study of intradiscal methylene blue injection for the treatment of lumbar discogenic pain. The objective of this study was to collect information about efficacy, safety, and acceptability of the intervention, gain and burden of outcome measures, and sample size assumptions for a potential following randomized controlled trial (RCT). If the pilot study demonstrates that this treatment is potentially effective and safe, and the methods and procedures used in this study are feasible, a RCT follows. Low back pain (LBP) is a highly common problem with a lifetime prevalence of more than 70%. A substantial part of chronic LBP is attributable to degenerative changes in the intervertebral disc. A recently published RCT assessing the treatment intradiscal injection of methylene blue for chronic discogenic LBP, showed exceptionally good results. Patients were selected on clinical criteria, magnetic resonance imaging, and a positive provocative discogram. The primary outcome measure was mean pain reduction at 6 months. Fifteen consecutive patients with chronic lumbar discogenic pain enrolled in a multicenter prospective case series in two interventional pain treatment centers in the Netherlands. Six months after the intervention, 40% of the patients claimed at least 30% pain relief. In patients who responded, physical function improved and medication use diminished. We observed no procedural complications or adverse events. Predictors for success were Pfirrmann grading of 2 or less and higher quality of life mental component scores. Our findings of 40% positive respondents, and no complications, give reason to set up a randomized, double-blind, placebo-controlled, trial. © 2015 World Institute of Pain.

  20. A daily-life-oriented intervention to improve prospective memory and goal-directed behaviour in ageing: a pilot study.

    PubMed

    Burkard, Christina; Rochat, Lucien; Blum, Anaëlle; Emmenegger, Joëlle; Juillerat Van der Linden, Anne-Claude; Van der Linden, Martial

    2014-01-01

    Difficulties in the execution of goal-directed behaviours, and particularly their prospective memory component, can arise in ageing and have important consequences for autonomy. The first objective of this article is to present an intervention that trained older individuals who reported prospective memory or goal-directed behaviour problems to use "implementation intentions". This technique, which has been shown to improve different aspects of goal-directed behaviour enactment, consists of establishing a mental (verbal and/or visual) link between the action that must be performed and the situation in which it must be performed. Our programme proposes exercises of progressively increasing difficulty that are targeted at daily life situations. Our second objective was to test the programme in small groups of older adults. Preliminary data regarding the programme's feasibility and its initial efficacy show a significant improvement in the main outcome measure, a questionnaire assessing goal-directed behaviours in everyday life. The participants also reported being significantly less bothered by their difficulties, although there were no significant changes in quality of life, self-esteem, anxiety or depression. Two participants with different psychological profiles, who benefited differently from the intervention, are then presented in more detail.

  1. Topical imiquimod 5% cream for pediatric plaque morphea: a prospective, multiple-baseline, open-label pilot study.

    PubMed

    Pope, Elena; Doria, Andrea S; Theriault, Marc; Mohanta, Arun; Laxer, Ronald M

    2011-01-01

    Therapeutic options for the treatment of plaque morphea are limited. We explored the efficacy and safety of imiquimod cream in children with plaque morphea. Prospective, open-label, double-baseline study, using imiquimod 5% cream topically for 9 months. The primary outcome measure was improvement in the thickening of morphea plaques using a visual analog scale (VAS) and the DIET score (dyspigmentation/induration/erythema/telangiectasia). Secondary outcome measures were clinicoradiographic correlations and frequency of adverse events. Nine patients, 89% females, with a mean age of 11.33 years (SD = 3.52) were enrolled. At 36 weeks, the mean VAS had decreased from 48.08 (SD = 18.85) to 22.7 (SD = 12.9) (p < 0.0001), and the mean DIET score from 4.38 (SD = 1.2) to 3.06 (SD = 1.39) (p = 0.23). There was very good interrater reliability between DIET score assessments (intraclass correlation coefficient, ICC = 0.75) and VAS (ICC = 0.59) and moderate agreement between parent and investigator VAS (ICC = 0.5). Ultrasonographically measured dermis thickness changed from 1.05 (SD = 0.34) to 0.95 (SD = 0.19) (p = 0.001). One patient experienced ulceration that required temporary discontinuation of intervention. This proof of concept study revealed that imiquimod 5% cream is effective in decreasing the thickening of plaque morphea and safe for pediatric use. Further prospective studies are warranted. Copyright © 2012 S. Karger AG, Basel.

  2. A crossover randomized prospective pilot study evaluating a central venous catheter team in reducing catheter-related bloodstream infections in pediatric oncology patients.

    PubMed

    Secola, Rita; Azen, Colleen; Lewis, Mary Ann; Pike, Nancy; Needleman, Jack; Sposto, Richard; Doering, Lynn

    2012-01-01

    Treatment for most children with cancer includes the use of a central venous catheter (CVC). CVCs provide reliable venous access for delivery of chemotherapy and supportive care. This advantage is mitigated by an increased risk of bloodstream infections (BSIs). Despite the ubiquitous use of CVCs, few prospective studies have been conducted to address infection prevention strategies in pediatric oncology patients. Prospective, crossover pilot study of a CVC team intervention versus standard care. Two inpatient oncology units in a metropolitan children's hospital. A total of 41 patients/135 admissions for the experimental unit (EU) and 41/129 admissions for the control unit (CU). Patients received a CVC blood draw bundle procedure by a CVC registered nurse (RN) team member (experimental intervention: EU) for 6 months and by the assigned bedside RN (standard care: CU) for 6 months. Feasibility of implementing a CVC RN team; a significant difference in CVC-related BSIs between the team intervention versus standard care and risk factors associated in the development of CVC-related BSIs were determined. There were 7 CVC-related BSIs/1238 catheter days in the EU group (5.7/1000 catheter days) versus 3 CVC-related BSIs/1419 catheter days in the CU group (2.1/1000 catheter days; P = .97). Selected risk factors were not significantly associated with the development of a CVC-related BSI. A CVC team in the care of pediatric oncology patients is feasible; however, a larger cohort will be required to adequately determine the effectiveness of the team reducing CVC-related BSIs.

  3. Prospective 1-year follow-up pilot study of CT-guided microwave ablation in the treatment of bone and soft-tissue malignant tumours.

    PubMed

    Aubry, Sébastien; Dubut, Jonathan; Nueffer, Jean-Philippe; Chaigneau, Loic; Vidal, Chrystelle; Kastler, Bruno

    2017-04-01

    The aims of this work were to assess the feasibility, efficacy, short-term outcome and safety of microwave ablation (MWA) in the treatment of malignant musculoskeletal tumours. Sixteen bone and soft-tissue malignant tumours were prospectively included and were treated by CT-guided MWA. The percentage and size of necrosis of the lesions were measured by contrast-enhanced MRI before the procedure and after 1, 3, 6 and 12 months. mRECIST criteria were used to assess tumour response. Procedural success was defined as ≥80 % necrosis. Patient pain (as assessed using a numeric visual scale (NVS)) and side effects were noted. Six osteolytic metastases, five osteoblastic metastases and five soft tissue sarcomas were treated. At 1 month, 40 % were treated completely, the percentage of necrosis was 85 ± 30.4 %, and the success rate was 80 %. At 3, 6 and 12 months the success rate was 80 %, 76.9 % and 63.6 %, respectively. At 12 months, four lesions (36.3 %) still had no recurrence. Mean NVS during the procedure was 3.5 ± 2.8. One patient had transitory sciatica without neurological deficit that was treated medically. CT-guided MWA of bone and soft-tissue malignant tumours is efficient, well tolerated and has good short-term anti-cancer effects. • CT-guided MWA is efficient in treating musculoskeletal malignant tumours. • This prospective pilot study showed MWA induces high percentages of tumour necrosis. • MWA has good short-term anti-cancer effects. • MWA has healing potential when lesions can be completely necrosed. • CT-guided MWA under equimolar mixture of oxygen-nitrous oxide inhalation is well tolerated.

  4. Safety and clinical performance of kyphoplasty and SpineJack(®) procedures in the treatment of osteoporotic vertebral compression fractures: a pilot, monocentric, investigator-initiated study.

    PubMed

    Noriega, D C; Ramajo, R H; Lite, I S; Toribio, B; Corredera, R; Ardura, F; Krüger, A

    2016-06-01

    Clinical performance and safety of two percutaneous vertebral cement augmentation (VA) procedures (SpineJack® and Kyphx Xpander® balloon) were compared in patients with osteoporotic compression fractures. Both techniques were safe, efficient, and led to a rapid and marked improvement in clinical signs; nevertheless, SpineJack showed better restoration of vertebral heights and angles, maintained over time. In patients with osteoporotic vertebral compression fractures (VCFs), both SpineJack® (SJ) and balloon kyphoplasty (BKP) led to a rapid and marked improvement in clinical signs. This pilot, monocentric, investigator-initiated, prospective study aimed to compare two percutaneous vertebral augmentation procedures in the painful osteoporotic VCF treatment. Thirty patients were randomized to receive SJ (n = 15) or BKP (n = 15). Analgesic consumption, back pain intensity (visual analog scale (VAS)), and Oswestry Disability Index (ODI) scores were recorded preoperatively, at 5 days and 1, 3, 6, and 12 months post-surgery. Quality of life (EQ-VAS score) was evaluated at 1, 3, 6, and 12 months. Spine X-rays were taken 48 h prior to procedure and 5 days and 6 and 12 months after. SpineJack® led to a significantly shorter intervention period (23 vs 32 min; p < 0.001), a strong, rapid, and long-lasting decline in pain (94 vs 82 % at 12 months) and in functional disability (94 vs 90 % at 12 months), a greater and sustainable mean correction of anterior (12 ± 13 vs 0 ± 7 % for BKP, p = 0.003) and central height (12 ± 10 vs 2 ± 6 % for BKP, p = 0.001) at 12 months, and a larger restoration of the vertebral body angle still evident 12 months after implantation (-4.4° ± 5.8° vs 0.2° ± 3.0° for BKP; p = 0.012). This pilot study showed that both techniques were safe and efficient for the osteoporotic VCF treatment. Radiological results indicate that the SpineJack® procedure has a higher potential for

  5. Effect of oral lactulose on clinical and immunohistochemical parameters in patients with inflammatory bowel disease: a pilot study

    PubMed Central

    Hafer, Anne; Krämer, Sigrid; Duncker, Swantje; Krüger, Martin; Manns, Michael P; Bischoff, Stephan C

    2007-01-01

    Background The prebiotic potential of lactulose is well established and preclinical studies demonstrated a protective effect of lactulose in murine models of colitis. The aim of the present study was to investigate the clinical and histological efficacy of lactulose in patients with inflammatory bowel disease (IBD), for which probiotic therapy yielded promising results. Methods Patients were treated with standard medication alone or combined with 10 g lactulose daily as adjuvant therapy for 4 months. Clinical efficacy of treatment was assessed using clinical activity indices, a quality of life index (IBDQ), endoscopic scores, defecation frequency and monitoring corticosteroid medication. Orsomucoid, alpha1-antitrypsin and other laboratory parameters were determined. In addition, in some participants colonic biopsies were analyzed with haematoxylin-eosin staining or with antibodies against HLA-DR, CD68, IgA and CD3, and evaluated systematically. All measurements were performed both at enrolment and at the end of the trial. Results 14 patients presenting ulcerative colitis (UC) and 17 patients presenting Crohn's disease (CD), most of them in a clinically active state, were enrolled in this pilot study. After 4 month no significant improvement of clinical activity index, endoscopic score or immunohistochemical parameters was observed in CD or UC patients receiving lactulose in comparison to the control group. However, significant improvement of quality of life was observed in UC patients receiving lactulose compared to the control group (p = 0.04). Conclusion The findings of the present pilot study indicate that oral lactulose has no beneficial effects in IBD patients in particular with regard to clinical activity, endoscopic score or immunohistochemical parameters. The importance of the beneficial effect of lactulose in UC patients regarding the quality of life needs further evaluation in larger controlled clinical trials. Trial registration Current Controlled Trials

  6. Using Social Media While Waiting in Pain: A Clinical 12-Week Longitudinal Pilot Study

    PubMed Central

    Gray, Kathleen; Martin-Sanchez, Fernando; Mantopoulos, Steven; Hogg, Malcolm

    2015-01-01

    Background Chronic pain places an enormous burden on health care systems. Multidisciplinary pain management services are well documented as an effective means to improve patient outcomes. However, waiting lists to access these services are long and outcomes deteriorate. Innovative solutions such as social media are gaining attention as a way to decrease this burden and improve outcomes. It is a challenge to design research that demonstrates whether social media are acceptable to patients and clinically effective. Objective The aim was to conduct a longitudinal pilot study to understand what aspects of research design are key to the success of running a larger-scale study of social media use in the clinical management of chronic pain. Methods A 12-week study examined social media use by patients on the waiting list for the Royal Melbourne Hospital Pain Management Service. Selected social media resources were suggested for use by patients waiting for an appointment at the clinic. Patients filled out measures for pain interference and pain self-efficacy before and after the study. Follow-up was conducted at monthly intervals via telephone semistructured interviews to discuss engagement and garner individual perceptions towards social media use. A social media-use instrument was also administered as part of the after-study questionnaire. Results Targeted recruitment refined 235 patient referrals to 138 (58.7%) suitable potential participants. Contact was made with 84 out of 138 (60.9%) patients. After a further exclusion of 54 out of 84 (64%) patients for various reasons, this left 30 out of 84 (36%) patients fitting the inclusion criteria and interested in study participation. A final study cohort of 17 out of 30 (57%) was obtained. Demographics of the 17 patients were mixed. Low back pain was the primary condition reported as leading to chronic pain. Semistructured interviews collected data from 16 out of 17 (94%) patients who started the trial, and at final follow

  7. Olfactory Mucosa Autografts in Human Spinal Cord Injury: A Pilot Clinical Study

    PubMed Central

    Lima, Carlos; Pratas-Vital, José; Escada, Pedro; Hasse-Ferreira, Armando; Capucho, Clara; Peduzzi, Jean D

    2006-01-01

    Background/Objective: Olfactory mucosa is a readily accessible source of olfactory ensheathing and stem-like progenitor cells for neural repair. To determine the safety and feasibility of transplanting olfactory mucosa autografts into patients with traumatically injured spinal cords, a human pilot clinical study was conducted. Methods: Seven patients ranging from 18 to 32 years of age (American Spinal Injury Association [ASIA] class A) were treated at 6 months to 6.5 years after injury. Olfactory mucosa autografts were transplanted into lesions ranging from 1 to 6 cm that were present at C4–T6 neurological levels. Operations were performed from July 2001 through March 2003. Magnetic resonance imaging (MRI), electromyography (EMG), and ASIA neurological and otolaryngological evaluations were performed before and after surgery. Results: MRI studies revealed moderate to complete filling of the lesion sites. Two patients reported return of sensation in their bladders, and one of these patients regained voluntary contraction of anal sphincter. Two of the 7 ASIA A patients became ASIA C. Every patient had improvement in ASIA motor scores. The mean increase for the 3 subjects with tetraplegia in the upper extremities was 6.3 ± 1.2 (SEM), and the mean increase for the 4 subjects with paraplegia in the lower extremities was 3.9 ± 1.0. Among the patients who improved in their ASIA sensory neurological scores (all except one patient), the mean increase was 20.3 ± 5.0 for light touch and 19.7 ± 4.6 for pinprick. Most of the recovered sensation below the initial level of injury was impaired. Adverse events included sensory decrease in one patient that was most likely caused by difficulty in locating the lesion, and there were a few instances of transient pain that was relieved by medication. EMG revealed motor unit potential when the patient was asked to perform movement. Conclusion: This study shows that olfactory mucosa autograft transplantation into the human injured

  8. Validation of a continuous, arterial pressure-based cardiac output measurement: a multicenter, prospective clinical trial.

    PubMed

    McGee, William T; Horswell, Jeffrey L; Calderon, Joachim; Janvier, Gerard; Van Severen, Tom; Van den Berghe, Greet; Kozikowski, Lori

    2007-01-01

    The present study compared measurements of cardiac output by an arterial pressure-based cardiac output (APCO) analysis method with measurement by intermittent thermodilution cardiac output (ICO) via pulmonary artery catheter in a clinical setting. The multicenter, prospective clinical investigation enrolled patients with a clinical indication for cardiac output monitoring requiring pulmonary artery and radial artery catheters at two hospitals in the United States, one hospital in France, and one hospital in Belgium. In 84 patients (69 surgical patients), the cardiac output was measured by analysis of the arterial pulse using APCO and was measured via pulmonary artery catheter by ICO; to establish a reference comparison, the cardiac output was measured by continuous cardiac output (CCO). Data were collected continuously by the APCO and CCO technologies, and at least every 4 hours by ICO. No clinical interventions were made as part of the study. For APCO compared with ICO, the bias was 0.20 l/min, the precision was +/- 1.28 l/min, and the limits of agreement were -2.36 l/m to 2.75 l/m. For CCO compared with ICO, the bias was 0.66 l/min, the precision was +/- 1.05 l/min, and the limits of agreement were -1.43 l/m to 2.76 l/m. The ability of APCO and CCO to assess changes in cardiac output was compared with that of ICO. In 96% of comparisons, APCO tracked the change in cardiac output in the same direction as ICO. The magnitude of change was comparable 59% of the time. For CCO, 95% of comparisons were in the same direction, with 58% of those changes being of similar magnitude. In critically ill patients in the intensive care unit, continuous measurement of cardiac output using either APCO or CCO is comparable with ICO. Further study in more homogeneous populations may refine specific situations where APCO reliability is strongest.

  9. Plasma C-Reactive Protein and Clinical Outcomes after Acute Ischemic Stroke: A Prospective Observational Study

    PubMed Central

    Matsuo, Ryu; Ago, Tetsuro; Hata, Jun; Wakisaka, Yoshinobu; Kuroda, Junya; Kuwashiro, Takahiro; Kitazono, Takanari; Kamouchi, Masahiro

    2016-01-01

    Background and Purpose Although plasma C-reactive protein (CRP) is elevated in response to inflammation caused by brain infarction, the association of CRP with clinical outcomes after acute ischemic stroke remains uncertain. This study examined whether plasma high-sensitivity CRP (hsCRP) levels at onset were associated with clinical outcomes after acute ischemic stroke independent of conventional risk factors and acute infections after stroke. Methods We prospectively included 3653 patients with first-ever ischemic stroke who had been functionally independent and were hospitalized within 24 h of onset. Plasma hsCRP levels were measured on admission and categorized into quartiles. The association between hsCRP levels and clinical outcomes, including neurological improvement, neurological deterioration, and poor functional outcome (modified Rankin scale ≥3 at 3 months), were investigated using a logistic regression analysis. Results Higher hsCRP levels were significantly associated with unfavorable outcomes after adjusting for age, sex, baseline National Institutes of Health Stroke Scale score, stroke subtype, conventional risk factors, intravenous thrombolysis and endovascular therapy, and acute infections during hospitalization (multivariate-adjusted odds ratios [95% confidence interval] in the highest quartile versus the lowest quartile as a reference: 0.80 [0.65–0.97] for neurological improvement, 1.72 [1.26–2.34] for neurological deterioration, and 2.03 [1.55–2.67] for a poor functional outcome). These associations were unchanged after excluding patients with infectious diseases occurring during hospitalization, or those with stroke recurrence or death. These trends were similar irrespective of stroke subtypes or baseline stroke severity, but more marked in patients aged <70 years (Pheterogeneity = 0.001). Conclusions High plasma hsCRP is independently associated with unfavorable clinical outcomes after acute ischemic stroke. PMID:27258004

  10. Antifungal Lock Therapy with Liposomal Amphotericin B: A Prospective Trial.

    PubMed

    McGhee, William; Michaels, Marian G; Martin, Judith M; Mazariegos, George V; Green, Michael

    2016-03-01

    We conducted a prospective pilot study to evaluate the potential role of combined systemic antifungal and liposomal amphotericin B lock therapy in children with intestinal insufficiency with fungal catheter-related bloodstream infections whose central venous catheters had not been removed. Our results provide supportive evidence for the conduct of larger clinical trials to confirm the efficacy and safety of this approach.

  11. Impact of sleep deprivation on anaesthesia residents' non-technical skills: a pilot simulation-based prospective randomized trial.

    PubMed

    Neuschwander, A; Job, A; Younes, A; Mignon, A; Delgoulet, C; Cabon, P; Mantz, J; Tesniere, A

    2017-07-01

    Sleep deprivation is common in anaesthesia residents, but its impact on performance remains uncertain. Non-technical skills (team working, situation awareness, decision making, and task management) are key components of quality of care in anaesthesia, particularly in crisis situations occurring in the operating room. The impact of sleep deprivation on non-technical skills is unknown. We tested the hypothesis that in anaesthesia residents sleep deprivation is associated with impaired non-technical skills. Twenty anaesthesia residents were randomly allocated to undergo a simulation session after a night shift [sleep-deprived (SLD) group, n =10] or after a night of rest [rested (R) group, n =10] from January to March 2015. The simulated scenario was a situation of crisis management in the operating room. The primary end point was a composite score of anaesthetists' non-technical skills (ANTS) assessed by two blinded evaluators. Non-technical skills were significantly impaired in the SLD group [ANTS score 12.2 (interquartile range 10.5-13)] compared with the R group [14.5 (14-15), P <0.02]. This difference was mainly accounted for by a difference in the team working item. On the day of simulation, the SLD group showed increased sleepiness and decreased confidence in anaesthesia skills. In this randomized pilot trial, sleep deprivation was associated with impaired non-technical skills of anaesthesia residents in a simulated anaesthesia intraoperative crisis scenario. NCT02622217.

  12. Serum lipid profile changes after successful treatment with electroconvulsive therapy in major depression: A prospective pilot trial.

    PubMed

    Aksay, Suna Su; Bumb, Jan Malte; Janke, Christoph; Biemann, Ronald; Borucki, Katrin; Lederbogen, Florian; Deuschle, Michael; Sartorius, Alexander; Kranaster, Laura

    2016-01-01

    Cholesterol is reduced in depressed patients, however, these patients have a higher risk for cardiovascular diseases. Electroconvulsive therapy (ECT) is a highly effective treatment option for specific forms of depression. Like for other non-pharmacological therapies targeting depression such as psychotherapy or sleep deprivation, there is a lack of evidence about the effects on peripheral lipid parameters. Our objective was to study the impact of ECT as a non-pharmacological treatment on the peripheral lipid pattern in depressive patients. Peripheral lipid profile composition before and after a course of ECT was analysed in 27 non-fasting inpatients at a university psychiatric hospital with DSM-IV major depressive episode. For the impact of ECT treatment on each lipid parameter a multivariate repeated measurement regression analysis was performed and computed separately for every dependent variable. Total Cholesterol and the cholesterol subtypes HDL and LDL were increased after the treatment compared to baseline. Apolipoprotein A1 was also increased after ECT, whereas apolipoprotein B was not. Indices for the prediction of cardiovascular diseases were unchanged after successful treatment by ECT. The reduction of depressive psychopathology negatively correlated with increases of HDL cholesterol and apolipoprotein A1. Subjects received several antidepressants and other psychotropic medication before and during the ECT. In our preliminary pilot study ECT as a non-pharmacological, effective treatment of depression led to distinct effects on the peripheral lipid pattern. Copyright © 2015 Elsevier B.V. All rights reserved.

  13. Clinical features and prognostic factors of listeriosis: the MONALISA national prospective cohort study.

    PubMed

    Charlier, Caroline; Perrodeau, Élodie; Leclercq, Alexandre; Cazenave, Benoît; Pilmis, Benoît; Henry, Benoît; Lopes, Amanda; Maury, Mylène M; Moura, Alexandra; Goffinet, François; Dieye, Hélène Bracq; Thouvenot, Pierre; Ungeheuer, Marie-Noëlle; Tourdjman, Mathieu; Goulet, Véronique; de Valk, Henriette; Lortholary, Olivier; Ravaud, Philippe; Lecuit, Marc

    2017-05-01

    Listeriosis is a severe foodborne infection and a notifiable disease in France. We did a nationwide prospective study to characterise its clinical features and prognostic factors. MONALISA was a national prospective observational cohort study. We enrolled eligible cases declared to the National Reference Center for Listeria (all microbiologically proven) between Nov 3, 2009, and July 31, 2013, in the context of mandatory reporting. The outcomes were analysis of clinical features, characterisation of Listeria isolates, and determination of predictors of 3-month mortality or persisting impairment using logistic regression. A hierarchical clustering on principal components was also done for neurological and bacteraemic cases. The study is registered at ClinicalTrials.gov, number NCT01520597. We enrolled 818 cases from 372 centres, including 107 maternal-neonatal infections, 427 cases of bacteraemia, and 252 cases of neurolisteriosis. Only five (5%) of 107 pregnant women had an uneventful outcome. 26 (24%) of 107 mothers experienced fetal loss, but never after 29 weeks of gestation or beyond 2 days of admission to hospital. Neurolisteriosis presented as meningoencephalitis in 212 (84%) of 252 patients; brainstem involvement was only reported in 42 (17%) of 252 patients. 3-month mortality was higher for bacteraemia than neurolisteriosis (hazard ratio [HR] 0·54 [95% CI 0·41-0·69], p<0·0001). For both bacteraemia and neurolisteriosis, the strongest mortality predictors were ongoing cancer (odds ratio [OR] 5·19 [95% CI 3·01-8·95], p<0·0001), multi-organ failure (OR 7·98 [4·32-14·72], p<0·0001), aggravation of any pre-existing organ dysfunction (OR 4·35 [2·79-6·81], p<0·0001), and monocytopenia (OR 3·70 [1·82-7·49], p=0·0003). Neurolisteriosis mortality was higher in blood-culture positive patients (OR 3·67 [1·60-8·40], p=0·002) or those receiving adjunctive dexamethasone (OR 4·58 [1·50-13·98], p=0·008). The severity of listeriosis is higher than

  14. Impact of Obesity on Orthodontic Tooth Movement in Adolescents: A Prospective Clinical Cohort Study.

    PubMed

    Saloom, H F; Papageorgiou, S N; Carpenter, G H; Cobourne, M T

    2017-05-01

    Obesity is a widespread chronic inflammatory disorder characterized by an increased overall disease burden and significant association with periodontitis. The aim of this prospective clinical cohort study was to investigate the effect of obesity on orthodontic tooth movement. Fifty-five adolescent patients (27 males, 28 females) with a mean (SD) age of 15.1 (1.7) years and mean (SD) body mass index (BMI) of 30.2 (3.5) kg/m(2) in obese and 19.4 (2.2) kg/m(2) in normal-weight groups were followed from start of treatment to completion of tooth alignment with fixed orthodontic appliances. Primary outcome was time taken to complete tooth alignment, while secondary outcomes included rate of tooth movement and change in clinical parameters (plaque/gingival indices, unstimulated whole-mouth salivary flow rate, gingival crevicular fluid biomarkers). Data collection took place at baseline (start of treatment: appliance placement), 1 h and 1 wk following appliance placement, and completion of alignment. Results were analyzed by descriptive statistics followed by generalized estimating equation regression modeling. There were no significant differences between groups in time taken to achieve tooth alignment (mean [SD] 158.7 [75.3] d; P = 0.486). However, at 1 wk, initial tooth displacement was significantly increased in the obese group ( P < 0.001), and after adjusting for confounders, obese patients had a significantly higher rate of tooth movement compared with normal-weight patients (+0.017 mm/d; 95% confidence interval, 0.008-0.025; P < 0.001) over the period of alignment. Explorative analyses indicated that levels of the adipokines leptin and resistin, the inflammatory marker myeloperoxidase (MPO), and the cytokine receptor for nuclear factor kappa-B ligand (RANKL) were significantly different between obese- and normal-weight patients and associated with observed rates of tooth movement. This represents the first prospective data demonstrating a different response in

  15. Prospective study of POLG mutations presenting in children with intractable epilepsy: prevalence and clinical features.

    PubMed

    Uusimaa, Johanna; Gowda, Vasantha; McShane, Anthony; Smith, Conrad; Evans, Julie; Shrier, Annie; Narasimhan, Manisha; O'Rourke, Anthony; Rajabally, Yusuf; Hedderly, Tammy; Cowan, Frances; Fratter, Carl; Poulton, Joanna

    2013-06-01

    To assess the frequency and clinical features of childhood-onset intractable epilepsy caused by the most common mutations in the POLG gene, which encodes the catalytic subunit of mitochondrial DNA polymerase gamma. Children presenting with nonsyndromic intractable epilepsy of unknown etiology but without documented liver dysfunction at presentation were eligible for this prospective, population-based study. Blood samples were analyzed for the three most common POLG mutations. If any of the three tested mutations were found, all the exons and the exon-intron boundaries of the POLG gene were sequenced. In addition, we retrospectively reviewed the notes of patients presenting with intractable epilepsy in which we had found POLG mutations. All available clinical data were collected by questionnaire and by reviewing the medical records. We analyzed 213 blood DNA samples from patients fulfilling the inclusion criteria of the prospective study. Among these, five patients (2.3%) were found with one of the three common POLG mutations as homozygous or compound heterozygous states. In addition, three patients were retrospectively identified. Seven of the eight patients had either raised cerebrospinal fluid (CSF) lactate (n = 3) or brain magnetic resonance imaging (MRI) changes (n = 4) at presentation with intractable epilepsy. Three patients later developed liver dysfunction, progressing to fatal liver failure in two without previous treatment with sodium valproate (VPA). Furthermore, it is worth mentioning that one patient presented first with an autism spectrum disorder before seizures emerged. Mutations in POLG are an important cause of early and juvenile onset nonsyndromic intractable epilepsy with highly variable associated manifestations including autistic features. This study emphasizes that genetic testing for POLG mutations in patients with nonsyndromic intractable epilepsies is very important for clinical diagnostics, genetic counseling, and treatment decisions

  16. Prospective study of POLG mutations presenting in children with intractable epilepsy: Prevalence and clinical features

    PubMed Central

    Uusimaa, Johanna; Gowda, Vasantha; McShane, Anthony; Smith, Conrad; Evans, Julie; Shrier, Annie; Narasimhan, Manisha; O'Rourke, Anthony; Rajabally, Yusuf; Hedderly, Tammy; Cowan, Frances; Fratter, Carl; Poulton, Joanna

    2013-01-01

    Purpose To assess the frequency and clinical features of childhood-onset intractable epilepsy caused by the most common mutations in the POLG gene, which encodes the catalytic subunit of mitochondrial DNA polymerase gamma. Methods Children presenting with nonsyndromic intractable epilepsy of unknown etiology but without documented liver dysfunction at presentation were eligible for this prospective, population-based study. Blood samples were analyzed for the three most common POLG mutations. If any of the three tested mutations were found, all the exons and the exon–intron boundaries of the POLG gene were sequenced. In addition, we retrospectively reviewed the notes of patients presenting with intractable epilepsy in which we had found POLG mutations. All available clinical data were collected by questionnaire and by reviewing the medical records. Key Findings We analyzed 213 blood DNA samples from patients fulfilling the inclusion criteria of the prospective study. Among these, five patients (2.3%) were found with one of the three common POLG mutations as homozygous or compound heterozygous states. In addition, three patients were retrospectively identified. Seven of the eight patients had either raised cerebrospinal fluid (CSF) lactate (n = 3) or brain magnetic resonance imaging (MRI) changes (n = 4) at presentation with intractable epilepsy. Three patients later developed liver dysfunction, progressing to fatal liver failure in two without previous treatment with sodium valproate (VPA). Furthermore, it is worth mentioning that one patient presented first with an autism spectrum disorder before seizures emerged. Significance Mutations in POLG are an important cause of early and juvenile onset nonsyndromic intractable epilepsy with highly variable associated manifestations including autistic features. This study emphasizes that genetic testing for POLG mutations in patients with nonsyndromic intractable epilepsies is very important for clinical diagnostics

  17. Hepatitis-C prevalence in an urban native-American clinic: a prospective screening study.

    PubMed Central

    Neumeister, Amy S.; Pilcher, LaVada E.; Erickson, Judi M.; Langley, Lora L.; Murphy, Mary M.; Haukaas, Nicole M.; Mailliard, Mark E.; Larsen, Jennifer L.

    2007-01-01

    BACKGROUND: Native-American populations are disproportionately burdened by chronic liver disease, and the prevalence of hepatitis C (HCV) in native Americans is unknown. PURPOSE: To determine the prevalence of hepatitis C in a local native-American population via a prospective screening study. PROCEDURES: Two-hundred-forty-three native Americans (161 females/82 males) using an urban clinic and representing > 30 tribes from across the United States were screened. Mean age was 41 +/- 1 years. Hepatitis-C screening was by anti-HCV with confirmation by HCV RNA. A questionnaire assessed potential risk factors for HCV. FINDINGS: Anti-HCV antibodies were found in 11.5% (95% CI: 7.5-15.5%). HCV RNA was present by polymerase chain reaction (PCR) in 8.6% (95% CI: 5.1-12.1%) and was more common in males [13.4% (95% CI: 6.0-20.8%)] than females [6.2% (95% CI: 2.5-9.9%)]. The most common potential risk factors for chronic HCV infection were intravenous (IV) drug or cocaine use (p < 0.0001), tattoos > 5 years old (p < 0.0001) and having a sexual partner with HCV (p = 0.0063). CONCLUSION: HCV prevalence is higher in an urban native-American clinic population than reported in the general U.S. population. Use of IV drugs is the most prevalent risk factor, but tattoos and sexual transmission may also be important. PMID:17444428

  18. Effectiveness of temporary implants in teenage patients: a prospective clinical trial.

    PubMed

    Lambert, France; Botilde, Gaëlle; Lecloux, Geoffrey; Rompen, Eric

    2017-09-01

    The objective of this study was to assess prospectively the outcomes of extra-narrow diameter implants (XNDI) placed in teenage patients as a temporary restorative option. Twenty consecutive young patients presenting one or several missing teeth received XNDI that were immediately restored with composite, Polymethylmethacrylate (Acrylic) or ceramic crown. Clinical and radiographical outcomes were assessed for a minimum follow-up period of 1 year. Additionally, each patient completed retrospectively a satisfaction questionnaire using Visual Analog Scale (VAS). A total of 30 implants were placed and followed for a period of 1-7.4 years (mean: 3.59 years). One implant failed after 3 weeks and was replaced successfully. No further biological complications occurred during the follow-up period, leading to an implant survival rate of 96.6%. The patient satisfaction evaluations displayed high levels of comfort and function. Immediately restored XNDI to replace missing teeth on teenager patients seems to be an effective temporary restorative option to replace missing teeth in young patients. Composite or ceramic crowns should be preferred. Clinical trials with long-term follow-ups and the assessment of passive egression are needed. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  19. Clinical spectrum of electrical burns - A prospective study from the developing world.

    PubMed

    Sokhal, Ashok Kumar; Lodha, Krishna Govind; Kumari, Manoj; Paliwal, Rajkumar; Gothwal, Sitaram

    2017-02-01

    Electrical burns are devastating, posing development of multiple injuries with high morbidity and mortality. Electrical burn management benefits from a multidisciplinary, multispecialty collaborative approach to improve outcomes. To highlight the clinical spectrum of electrical burns in the developing world, including common etiologies, presentation, intervention, associated injuries, and complications. A prospective study was conducted from January 2010 to December 2015 that included 78 patients (75 men and 3 women), who presented with a history of electrical burns. Patients were interviewed for detailed clinical history and physical examination. The study comprised 78 patients (high-voltage group: 38.46% and low-voltage group: 61.54%). The most affected age group was the 21-40 year age group. High-voltage injuries were more devastating. The most common complication was septicemia in 24.4% of the patients, which included 43.3% from the high-voltage group. Electrical burns affecting young adult men can impose a significant burden in developing countries. Electrical burns, especially due to high voltage, involve multiple organs benefitting from multidisciplinary management and have significant residual sequelae. Public awareness and education and proper training of industry workers remain the best way to minimize the prevalence of electric burns in the developing world. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

  20. Psorinum Therapy in Treating Stomach, Gall Bladder, Pancreatic, and Liver Cancers: A