Modeling the Impact of Control on the Attractiveness of Risk in a Prospect Theory Framework.

PubMed

Young, Diana L; Goodie, Adam S; Hall, Daniel B

2011-01-01

Many decisions involve a degree of personal control over event outcomes, which is exerted through one's knowledge or skill. In three experiments we investigated differences in decision making between prospects based on a) the outcome of random events and b) the outcome of events characterized by control. In Experiment 1, participants estimated certainty equivalents (CEs) for bets based on either random events or the correctness of their answers to U.S. state population questions across the probability spectrum. In Experiment 2, participants estimated CEs for bets based on random events, answers to U.S. state population questions, or answers to questions about 2007 NCAA football game results. Experiment 3 extended the same procedure as Experiment 1 using a within-subjects design. We modeled data from all experiments in a prospect theory framework to establish psychological mechanisms underlying decision behavior. Participants weighted the probabilities associated with bets characterized by control so as to reflect greater risk attractiveness relative to bets based on random events, as evidenced by more elevated weighting functions under conditions of control. This research elucidates possible cognitive mechanisms behind increased risk taking for decisions characterized by control, and implications for various literatures are discussed.

Prospective Dutch colorectal cancer cohort: an infrastructure for long-term observational, prognostic, predictive and (randomized) intervention research.

PubMed

Burbach, J P M; Kurk, S A; Coebergh van den Braak, R R J; Dik, V K; May, A M; Meijer, G A; Punt, C J A; Vink, G R; Los, M; Hoogerbrugge, N; Huijgens, P C; Ijzermans, J N M; Kuipers, E J; de Noo, M E; Pennings, J P; van der Velden, A M T; Verhoef, C; Siersema, P D; van Oijen, M G H; Verkooijen, H M; Koopman, M

2016-11-01

Systematic evaluation and validation of new prognostic and predictive markers, technologies and interventions for colorectal cancer (CRC) is crucial for optimizing patients' outcomes. With only 5-15% of patients participating in clinical trials, generalizability of results is poor. Moreover, current trials often lack the capacity for post-hoc subgroup analyses. For this purpose, a large observational cohort study, serving as a multiple trial and biobanking facility, was set up by the Dutch Colorectal Cancer Group (DCCG). The Prospective Dutch ColoRectal Cancer cohort is a prospective multidisciplinary nationwide observational cohort study in the Netherlands (yearly CRC incidence of 15 500). All CRC patients (stage I-IV) are eligible for inclusion, and longitudinal clinical data are registered. Patients give separate consent for the collection of blood and tumor tissue, filling out questionnaires, and broad randomization for studies according to the innovative cohort multiple randomized controlled trial design (cmRCT), serving as an alternative study design for the classic RCT. Objectives of the study include: 1) systematically collected long-term clinical data, patient-reported outcomes and biomaterials from daily CRC practice; and 2) to facilitate future basic, translational and clinical research including interventional and cost-effectiveness studies for both national and international research groups with short inclusion periods, even for studies with stringent inclusion criteria. Seven months after initiation 650 patients have been enrolled, eight centers participate, 15 centers await IRB approval and nine embedded cohort- or cmRCT-designed studies are currently recruiting patients. This cohort provides a unique multidisciplinary data, biobank, and patient-reported outcomes collection initiative, serving as an infrastructure for various kinds of research aiming to improve treatment outcomes in CRC patients. This comprehensive design may serve as an example for other tumor types.

Effect of Fresh Fruit Availability at Worksites on the Fruit and Vegetable Consumption of Low-Wage Employees

ERIC Educational Resources Information Center

Backman, Desiree; Gonzaga, Gian; Sugerman, Sharon; Francis, Dona; Cook, Sara

2011-01-01

Objective: To examine the impact of fresh fruit availability at worksites on the fruit and vegetable consumption and related psychosocial determinants of low-wage employees. Design: A prospective, randomized block experimental design. Setting: Seven apparel manufacturing and 2 food processing worksites. Participants: A convenience sample of 391…

Iodine and mental development of children 5 years old and under: a systematic review and meta-analysis.

PubMed

Bougma, Karim; Aboud, Frances E; Harding, Kimberly B; Marquis, Grace S

2013-04-22

Several reviews and meta-analyses have examined the effects of iodine on mental development. None focused on young children, so they were incomplete in summarizing the effects on this important age group. The current systematic review therefore examined the relationship between iodine and mental development of children 5 years old and under. A systematic review of articles using Medline (1980-November 2011) was carried out. We organized studies according to four designs: (1) randomized controlled trial with iodine supplementation of mothers; (2) non-randomized trial with iodine supplementation of mothers and/or infants; (3) prospective cohort study stratified by pregnant women's iodine status; (4) prospective cohort study stratified by newborn iodine status. Average effect sizes for these four designs were 0.68 (2 RCT studies), 0.46 (8 non-RCT studies), 0.52 (9 cohort stratified by mothers' iodine status), and 0.54 (4 cohort stratified by infants' iodine status). This translates into 6.9 to 10.2 IQ points lower in iodine deficient children compared with iodine replete children. Thus, regardless of study design, iodine deficiency had a substantial impact on mental development. Methodological concerns included weak study designs, the omission of important confounders, small sample sizes, the lack of cluster analyses, and the lack of separate analyses of verbal and non-verbal subtests. Quantifying more precisely the contribution of iodine deficiency to delayed mental development in young children requires more well-designed randomized controlled trials, including ones on the role of iodized salt.

An evaluation of biodegradable synthetic polyurethane foam in patients following septoplasty: a prospective randomized trial.

PubMed

Yilmaz, Mahmut Sinan; Guven, Mehmet; Elicora, Sultan Sevik; Kaymaz, Recep

2013-01-01

The purpose of this study is to examine the usability of biodegradable synthetic polyurethane foam (BSPF) after septoplasty by comparing it with Merocel and silicone intranasal splints as packing materials in terms of patient comfort and efficiency. A prospective, unmasked, randomized trial. A tertiary referral center. This study was designed to be a prospective, randomized clinical trial. Sixty-eight patients who underwent septoplasty were included in this study. The patients were randomized to receive Merocel, silicone intranasal septal splint (INS), or BSPF after septoplasty. Clinical efficacy on bleeding, pain, and subjective symptoms related to packing materials was evaluated. There was a statistically significant difference between the Merocel group and the other 2 groups in terms of bleeding and adhesion. The average score on the pain scale was 2.47 ± 1.01 for BSPF, 3.68 ± 1.27 for INS, and 6 ± 2.21 for Merocel. Scores on general satisfaction scales were 6.95 ± 1.42 for Merocel, 8.44 ± 2.12 for INS, and 8.28 ± 1.88 for BSPF. The efficacy of BSPF was comparable with that of Merocel and INS. Biodegradable synthetic polyurethane foam significantly reduced pain and patient discomfort during packing and removal, followed by INS, compared with Merocel.

Analysis of Combined Data from Heterogeneous Study Designs: A Methodological Proposal from the Patient Navigation Research program

PubMed Central

Roetzheim, Richard G.; Freund, Karen M.; Corle, Don K.; Murray, David M.; Snyder, Frederick R.; Kronman, Andrea C.; Jean-Pierre, Pascal; Raich, Peter C.; Holden, Alan E. C.; Darnell, Julie S.; Warren-Mears, Victoria; Patierno, Steven; Design, PNRP; Committee, Analysis

2013-01-01

Background The Patient Navigation Research Program (PNRP) is a cooperative effort of nine research projects, each employing its own unique study design. To evaluate projects such as PNRP, it is desirable to perform a pooled analysis to increase power relative to the individual projects. There is no agreed upon prospective methodology, however, for analyzing combined data arising from different study designs. Expert opinions were thus solicited from members of the PNRP Design and Analysis Committee Purpose To review possible methodologies for analyzing combined data arising from heterogeneous study designs. Methods The Design and Analysis Committee critically reviewed the pros and cons of five potential methods for analyzing combined PNRP project data. Conclusions were based on simple consensus. The five approaches reviewed included: 1) Analyzing and reporting each project separately, 2) Combining data from all projects and performing an individual-level analysis, 3) Pooling data from projects having similar study designs, 4) Analyzing pooled data using a prospective meta analytic technique, 5) Analyzing pooled data utilizing a novel simulated group randomized design. Results Methodologies varied in their ability to incorporate data from all PNRP projects, to appropriately account for differing study designs, and in their impact from differing project sample sizes. Limitations The conclusions reached were based on expert opinion and not derived from actual analyses performed. Conclusions The ability to analyze pooled data arising from differing study designs may provide pertinent information to inform programmatic, budgetary, and policy perspectives. Multi-site community-based research may not lend itself well to the more stringent explanatory and pragmatic standards of a randomized controlled trial design. Given our growing interest in community-based population research, the challenges inherent in the analysis of heterogeneous study design are likely to become more salient. Discussion of the analytic issues faced by the PNRP and the methodological approaches we considered may be of value to other prospective community-based research programs. PMID:22273587

Analysis of combined data from heterogeneous study designs: an applied example from the patient navigation research program.

PubMed

Roetzheim, Richard G; Freund, Karen M; Corle, Don K; Murray, David M; Snyder, Frederick R; Kronman, Andrea C; Jean-Pierre, Pascal; Raich, Peter C; Holden, Alan Ec; Darnell, Julie S; Warren-Mears, Victoria; Patierno, Steven

2012-04-01

The Patient Navigation Research Program (PNRP) is a cooperative effort of nine research projects, with similar clinical criteria but with different study designs. To evaluate projects such as PNRP, it is desirable to perform a pooled analysis to increase power relative to the individual projects. There is no agreed-upon prospective methodology, however, for analyzing combined data arising from different study designs. Expert opinions were thus solicited from the members of the PNRP Design and Analysis Committee. To review possible methodologies for analyzing combined data arising from heterogeneous study designs. The Design and Analysis Committee critically reviewed the pros and cons of five potential methods for analyzing combined PNRP project data. The conclusions were based on simple consensus. The five approaches reviewed included the following: (1) analyzing and reporting each project separately, (2) combining data from all projects and performing an individual-level analysis, (3) pooling data from projects having similar study designs, (4) analyzing pooled data using a prospective meta-analytic technique, and (5) analyzing pooled data utilizing a novel simulated group-randomized design. Methodologies varied in their ability to incorporate data from all PNRP projects, to appropriately account for differing study designs, and to accommodate differing project sample sizes. The conclusions reached were based on expert opinion and not derived from actual analyses performed. The ability to analyze pooled data arising from differing study designs may provide pertinent information to inform programmatic, budgetary, and policy perspectives. Multisite community-based research may not lend itself well to the more stringent explanatory and pragmatic standards of a randomized controlled trial design. Given our growing interest in community-based population research, the challenges inherent in the analysis of heterogeneous study design are likely to become more salient. Discussion of the analytic issues faced by the PNRP and the methodological approaches we considered may be of value to other prospective community-based research programs.

Long-term Clinical Outcomes of Cervical Disc Arthroplasty: A Prospective, Randomized, Controlled Trial.

PubMed

Sasso, Willa R; Smucker, Joseph D; Sasso, Maria P; Sasso, Rick C

2017-02-15

Prospective, randomized, single-center, clinical trial. To prospectively examine the 7- and 10-year outcomes of cervical arthroplasty to anterior cervical discectomy and fusion (ACDF). Degeneration of the cervical discs causing radiculopathy is a frequent source of surgical intervention, commonly treated with ACDF. Positive clinical outcomes are associated with arthrodesis techniques, yet there remains a long-term concern for adjacent segment change. Cervical disc arthroplasty has been designed to mitigate some of the challenges associated with arthrodesis whereas providing for a similar positive neurological outcome. As data has been collected from numerous prospective US FDA IDE trials, longer term outcomes regarding adjacent segment change may be examined. As part of an FDA IDE trial, a single center collected prospective outcomes data on 47 patients randomized in a 1:1 ratio to ACDF or arthroplasty. Success of both surgical interventions remained high at the 10-year interval. Both arthrodesis and arthroplasty demonstrated statistically significant improvements in neck disability index, visual analog scale neck and arm pain scores at all intervals including 7- and 10-year periods. Arthroplasty demonstrated an advantage in comparison to arthrodesis as measured by final 10-year NDI score (8 vs. 16, P = 0.0485). Patients requiring reoperation were higher in number in the arthrodesis cohort (32%) in comparison with arthroplasty (9%) (P = 0.055). At 7 and 10 years, cervical arthroplasty compares favorably with ACDF as defined by standard outcomes scores in a highly selected population with radiculopathy. 1.

An Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective Randomized Control Trials

PubMed Central

Logan, Jennifer K; Tang, Chad; Liao, Zhongxing; Lee, J. Jack; Heymach, John V.; Swisher, Stephen G.; Welsh, James W.; Zhang, Jianjun; Lin, Steven H.; Gomez, Daniel R.

2018-01-01

Purpose Effective clinical trial enrollment can be difficult in a protocol designs that contain one treatment arm that is perceived as being more “aggressive” or “favorable.” There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to enrollment, particularly the influence of timing, in context of three prospective randomized oncology trials where one arm was considered more aggressive. Methods and materials From June 2011 to March 2015, patients who were enrolled on three prospective institutional protocols (an oligometastatic non-small cell lung cancer (NSCLC) trial, and two proton vs. intensity-modulated radiation therapy (IMRT) trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher’s exact test, Student’s t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results 309 eligible patients were approached about trial enrollment. The enrollment success rate (ESR) during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligomet protocol: 5 vs. 3 appointments (P<0.001), NSCLC protocol: 4 vs. 3 appointments (P = 0.0018), esophageal protocol: 3 vs. 2 appointments (P = 0.0086No other factors or patient characteristics significantly affected ESR. Conclusion Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success, and may help overcome accrual barriers without compromising trial design. PMID:28244413

CERAMENT treatment of fracture defects (CERTiFy): protocol for a prospective, multicenter, randomized study investigating the use of CERAMENT™ BONE VOID FILLER in tibial plateau fractures

PubMed Central

2014-01-01

Background Bone graft substitutes are widely used for reconstruction of posttraumatic bone defects. However, their clinical significance in comparison to autologous bone grafting, the gold-standard in reconstruction of larger bone defects, still remains under debate. This prospective, randomized, controlled clinical study investigates the differences in pain, quality of life, and cost of care in the treatment of tibia plateau fractures-associated bone defects using either autologous bone grafting or bioresorbable hydroxyapatite/calcium sulphate cement (CERAMENT™|BONE VOID FILLER (CBVF)). Methods/Design CERTiFy (CERament™ Treatment of Fracture defects) is a prospective, multicenter, controlled, randomized trial. We plan to enroll 136 patients with fresh traumatic depression fractures of the proximal tibia (types AO 41-B2 and AO 41-B3) in 13 participating centers in Germany. Patients will be randomized to receive either autologous iliac crest bone graft or CBVF after reduction and osteosynthesis of the fracture to reconstruct the subchondral bone defect and prevent the subsidence of the articular surface. The primary outcome is the SF-12 Physical Component Summary at week 26. The co-primary endpoint is the pain level 26 weeks after surgery measured by a visual analog scale. The SF-12 Mental Component Summary after 26 weeks and costs of care will serve as key secondary endpoints. The study is designed to show non-inferiority of the CBVF treatment to the autologous iliac crest bone graft with respect to the physical component of quality of life. The pain level at 26 weeks after surgery is expected to be lower in the CERAMENT bone void filler treatment group. Discussion CERTiFy is the first randomized multicenter clinical trial designed to compare quality of life, pain, and cost of care in the use of the CBVF and the autologous iliac crest bone graft in the treatment of tibia plateau fractures. The results are expected to influence future treatment recommendations. Trial registration number ClinicalTrials.gov: NCT01828905 PMID:24606670

Different effectiveness of closed embryo culture system with time-lapse imaging (EmbryoScope(TM)) in comparison to standard manual embryology in good and poor prognosis patients: a prospectively randomized pilot study.

PubMed

Wu, Yan-Guang; Lazzaroni-Tealdi, Emanuela; Wang, Qi; Zhang, Lin; Barad, David H; Kushnir, Vitaly A; Darmon, Sarah K; Albertini, David F; Gleicher, Norbert

2016-08-24

Previously manual human embryology in many in vitro fertilization (IVF) centers is rapidly being replaced by closed embryo incubation systems with time-lapse imaging. Whether such systems perform comparably to manual embryology in different IVF patient populations has, however, never before been investigated. We, therefore, prospectively compared embryo quality following closed system culture with time-lapse photography (EmbryoScope™) and standard embryology. We performed a two-part prospectively randomized study in IVF (clinical trial # NCT92256309). Part A involved 31 infertile poor prognosis patients prospectively randomized to EmbryoScope™ and standard embryology. Part B involved embryos from 17 egg donor-recipient cycles resulting in large egg/embryo numbers, thus permitting prospectively alternative embryo assignments to EmbryoScope™ and standard embryology. We then compared pregnancy rates and embryo quality on day-3 after fertilization and embryologist time utilized per processed embryo. Part A revealed in poor prognosis patients no differences in day-3 embryo scores, implantation and clinical pregnancy rates between EmbryoScope™ and standard embryology. The EmbryoScope™, however, more than doubled embryology staff time (P < 0.0001). In Part B, embryos grown in the EmbyoScope™ demonstrated significantly poorer day-3 quality (depending on embryo parameter between P = 0.005 and P = 0.01). Suspicion that conical culture dishes of the EmbryoScope™ (EmbryoSlide™) may be the cause was disproven when standard culture dishes demonstrated no outcome difference in standard incubation. Though due to small patient numbers preliminary, this study raises concerns about the mostly uncontrolled introduction of closed incubation systems with time lapse imaging into routine clinical embryology. Appropriately designed and powered prospectively randomized studies appear urgently needed in well-defined patient populations before the uncontrolled utilization of these instruments further expands. NCT02246309 Registered September 18, 2014.

76 FR 48164 - Agency Forms Undergoing Paperwork Reduction Act Review

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-08

... using a prospective experimental design (multiple baselines across groups with randomization). The costs... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-11-11FE] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention...

76 FR 44336 - Agency Forms Undergoing Paperwork Reduction Act Review

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-25

... using a prospective experimental design (multiple baselines across groups with randomization). The costs... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-11-11FE] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention...

Patterns of antimicrobial use for respiratory tract infections in older residents of long-term care facilities

USDA-ARS?s Scientific Manuscript database

OBJECTIVE: To describe patterns of antimicrobial use for respiratory tract infections (RTIs) among elderly residents of long-term care facilities (LTCFs). DESIGN: Data from a prospective, randomized, controlled study conducted from April 1998 through August 2001 to investigate the effect of vitamin ...

REDUCTION IN ASTHMA MORBIDITY IN CHILDREN AS A RESULT OF HOME REMEDIATION AIMED AT MOISTURE SOURCES

EPA Science Inventory

Objective: Home dampness, presence of mold and allergens have been associated with asthma morbidity. We examined changes in asthma morbidity in children as a result of home remediation aimed at moisture sources.

Design: Prospective, randomized controlled trial.

Part...

Maternal Attachment Behaviors with Adopted and Birth Infants.

ERIC Educational Resources Information Center

Chan, Marilyn M.

This study investigated: (1) effects of teaching mothers the unique behavioral cues of their adopted infants and (2) potential differences between the mothering practices of adoptive and birth mothers. A pretest, posttest experimental prospective design was used with random assignment of mother-infant dyads. Mother-adopted infant dyads were…

Arthroscopic cartilage debridement by excimer laser in chondromalacia of the knee joint. A prospective randomized clinical study.

PubMed

Raunest, J; Löhnert, J

1990-01-01

A new operative technique in arthroscopic treatment of chondromalacia using ultraviolet laser systems is introduced. The postoperative results are evaluated in a prospective and randomized clinical trial. One hundred and forty patients stage II or III chondromalacia according to Outerbridge were randomly assigned to arthroscopic operation using either laser or mechanical instruments. After a 6-month follow-up period the clinical results were compared, guided by a specially designed modification of the Lysholm scoring scale. In the short-term follow-up laser surgery gave superior results in regard to reducing pain (P less than 0.05) and leading to a lower incidence of reactive synovitis (P less than 0.01). No difference was found in respect of disability and functional impairment. Our results lead to the conclusion that arthroscopic laser application seems to be a successful procedure in the treatment of degenerative cartilage disorders, providing precise ablation of tissue without significant thermal damage to the remaining cartilage.

Update on the Methodological Quality of Research Published in The American Journal of Sports Medicine: Comparing 2011-2013 to 10 and 20 Years Prior.

PubMed

Brophy, Robert H; Kluck, Dylan; Marx, Robert G

2016-05-01

In recent years, the number of articles in The American Journal of Sports Medicine (AJSM) has risen dramatically, with an increasing emphasis on evidence-based medicine in orthopaedics and sports medicine. Despite the increase in the number of articles published in AJSM over the past decade, the methodological quality of articles in 2011-2013 has improved relative to those in 2001-2003 and 1991-1993. Meta-analysis. All articles published in AJSM during 2011-2013 were reviewed and classified by study design. For each article, the use of pertinent methodologies, such as prospective data collection, randomization, control groups, and blinding, was recorded. The frequency of each article type and the use of evidence-based techniques were compared relative to 1991-1993 and 2001-2003 by use of Pearson χ(2) testing. The number of research articles published in AJSM more than doubled from 402 in 1991-1993 and 423 in 2001-2003 to 953 in 2011-2013. Case reports decreased from 15.2% to 10.6% to 2.1% of articles published over the study period (P < .001). Cadaveric/human studies and meta-analysis/literature review studies increased from 5.7% to 7.1% to 12.4% (P < .001) and from 0.2% to 0.9% to 2.3% (P = .01), respectively. Randomized, prospective clinical trials increased from 2.7% to 5.9% to 7.4% (P = .007). Fewer studies used retrospective compared with prospective data collection (P < .001). More studies tested an explicit hypothesis (P < .001) and used controls (P < .001), randomization (P < .001), and blinding of those assessing outcomes (P < .001). Multi-investigator trials increased (P < .001), as did the proportion of articles citing a funding source (P < .001). Despite a dramatic increase in the number of published articles, the research published in AJSM shifted toward more prospective, randomized, controlled, and blinded designs during 2011-2013 compared with 2001-2003 and 1991-1993, demonstrating a continued improvement in methodological quality. © 2015 The Author(s).

Efficacy and Safety of Gabapentin in the Treatment of Chronic Cough: A Systematic Review.

PubMed

Shi, Guanglin; Shen, Qin; Zhang, Caixin; Ma, Jun; Mohammed, Anaz; Zhao, Huan

2018-06-19

Despite recent clinical guidelines, the optimal therapeutic strategy for the management of refractory chronic cough is still a challenge. The present systematic review was designed to assess the evidence for efficacy and safety of gabapentin in the treatment of chronic cough. A systematic search of PubMed, Embase, Cochrane Library databases, and publications cited in bibliographies was performed. Articles were searched by two reviewers with a priori criteria for study selection. Seven relevant articles were identified, including two randomized controlled trials, one prospective case-series designed with consecutive patients, one retrospective case series of consecutive patients, one retrospective case series with unknown consecutive status, and two case reports comprising six and two patients, respectively. Improvements were detected in cough-specific quality of life (Leicester Cough Questionnaire score) and cough severity (visual analogue scale score) following gabapentin treatment in randomized controlled trials. The results of prospective case-series showed that the rate of overall improvement of cough and sensory neuropathy with gabapentin was 68%. Gabapentin treatment of patients with chronic cough showed superior efficacy and a good safety record compared with placebo or standard medications. Additional randomized and controlled trials are needed. Copyright©2018. The Korean Academy of Tuberculosis and Respiratory Diseases.

The risk-stratified osteoporosis strategy evaluation study (ROSE): a randomized prospective population-based study. Design and baseline characteristics.

PubMed

Rubin, Katrine Hass; Holmberg, Teresa; Rothmann, Mette Juel; Høiberg, Mikkel; Barkmann, Reinhard; Gram, Jeppe; Hermann, Anne Pernille; Bech, Mickael; Rasmussen, Ole; Glüer, Claus C; Brixen, Kim

2015-02-01

The risk-stratified osteoporosis strategy evaluation study (ROSE) is a randomized prospective population-based study investigating the effectiveness of a two-step screening program for osteoporosis in women. This paper reports the study design and baseline characteristics of the study population. 35,000 women aged 65-80 years were selected at random from the population in the Region of Southern Denmark and-before inclusion-randomized to either a screening group or a control group. As first step, a self-administered questionnaire regarding risk factors for osteoporosis based on FRAX(®) was issued to both groups. As second step, subjects in the screening group with a 10-year probability of major osteoporotic fractures ≥15% were offered a DXA scan. Patients diagnosed with osteoporosis from the DXA scan were advised to see their GP and discuss pharmaceutical treatment according to Danish National guidelines. The primary outcome is incident clinical fractures as evaluated through annual follow-up using the Danish National Patient Registry. The secondary outcomes are cost-effectiveness, participation rate, and patient preferences. 20,904 (60%) women participated and included in the baseline analyses (10,411 in screening and 10,949 in control group). The mean age was 71 years. As expected by randomization, the screening and control groups had similar baseline characteristics. Screening for osteoporosis is at present not evidence based according to the WHO screening criteria. The ROSE study is expected to provide knowledge of the effectiveness of a screening strategy that may be implemented in health care systems to prevent fractures.

Safety of 6-month duration of dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndromes: Rationale and design of the Smart Angioplasty Research Team-safety of 6-month duration of Dual Antiplatelet Therapy after percutaneous coronary intervention in patients with acute coronary syndromes (SMART-DATE) prospective multicenter randomized trial.

PubMed

Lee, Joo Myung; Cho, Deok-Kyu; Hahn, Joo-Yong; Song, Young Bin; Park, Taek Kyu; Oh, Ju-Hyeon; Lee, Jin Bae; Doh, Joon-Hyung; Kim, Sang-Hyun; Yang, Jeong Hoon; Choi, Jin-Ho; Choi, Seung-Hyuck; Lee, Sang Hoon; Gwon, Hyeon-Cheol

2016-12-01

Dual antiplatelet therapy (DAPT) is a fundamental treatment that optimizes clinical outcomes after percutaneous coronary intervention, especially in patients with acute coronary syndrome (ACS). Although current international guidelines recommend DAPT for at least 12 months after implantation of a drug-eluting stent in patients with ACS, these recommendations are not based on randomized controlled trials dedicated to ACS population. The SMART-DATE trial is a prospective, multicenter, randomized, and open-label study to demonstrate the noninferiority of 6-month DAPT compared with 12 months or longer DAPT in patients with ACS undergoing percutaneous coronary intervention. A total of 2,700 patients will undergo prospective, random assignment to either of the DAPT duration groups. To minimize the bias from different stent devices, the type of stents will be randomly assigned (everolimus-eluting stents, zotarolimus-eluting stents, or biolimus A9-eluting stents). The primary end point is a composite of all-cause death, myocardial infarction, and cerebrovascular events at 18 months after the index procedure. The major secondary end points are definite/probable stent thrombosis defined by the Academic Research Consortium and bleeding defined by Bleeding Academic Research Consortium type 2-5. The SMART-DATE randomized trial is the first study exploring the safety of 6-month DAPT compared with conventional 12-month or longer DAPT dedicated to patients with ACS after second-generation drug-eluting stent implantation. Copyright © 2016 Elsevier Inc. All rights reserved.

Effectiveness of braces designed using computer-aided design and manufacturing (CAD/CAM) and finite element simulation compared to CAD/CAM only for the conservative treatment of adolescent idiopathic scoliosis: a prospective randomized controlled trial.

PubMed

Cobetto, N; Aubin, C E; Parent, S; Clin, J; Barchi, S; Turgeon, I; Labelle, Hubert

2016-10-01

Clinical assessment of immediate in-brace effect of braces designed using CAD/CAM and FEM vs. only CAD/CAM for conservative treatment of AIS, using a randomized blinded and controlled study design. Forty AIS patients were prospectively recruited and randomized into two groups. For 19 patients (control group), the brace was designed using a scan of patient's torso and a conventional CAD/CAM approach (CtrlBrace). For the 21 other patients (test group), the brace was additionally designed using finite element modeling (FEM) and 3D reconstructions of spine, rib cage and pelvis (NewBrace). The NewBrace design was simulated and iteratively optimized to maximize the correction and minimize the contact surface and material. Both groups had comparable age, sex, weight, height, curve type and severity. Scoliosis Research Society standardized criteria for bracing were followed. Average Cobb angle prior to bracing was 27° and 28° for main thoracic (MT) and lumbar (L) curves, respectively, for the control group, while it was 33° and 28° for the test group. CtrlBraces reduced MT and L curves by 8° (29 %) and 10° (40 %), respectively, compared to 14° (43 %) and 13° (46 %) for NewBraces, which were simulated with a difference inferior to 5°. NewBraces were 50 % thinner and had 20 % less covering surface than CtrlBraces. Braces designed with CAD/CAM and 3D FEM simulation were more efficient and lighter than standard CAD/CAM TLSO's at first immediate in-brace evaluation. These results suggest that long-term effect of bracing in AIS may be improved using this new platform for brace fabrication. NCT02285621.

Treatment of benign esophageal stricture by Eder-Puestow or balloon dilators: a comparison between randomized and prospective nonrandomized trials.

PubMed

Yamamoto, H; Hughes, R W; Schroeder, K W; Viggiano, T R; DiMagno, E P

1992-03-01

To determine whether the natural history of strictures is affected by the type of dilator used to treat newly diagnosed peptic strictures, we designed a prospective randomized trial to compare the results after Eder-Puestow or Medi-Tech balloon dilation. We entered 31 patients into the trial. We also prospectively followed up all 92 nonrandomized patients who underwent their first dilation for a benign stricture during the same period as the prospective randomized trial. The nonrandomized patients also underwent dilation with either the Eder-Puestow or the balloon technique at the discretion of the gastroenterologist performing the endoscopy. We found no statistically significant differences in the immediate or long-term results of the two methods among the randomized, nonrandomized, and overall combined groups. All but 1 of the 123 patients had immediate relief of dysphagia. Within each group of patients, the probability of remaining free of dysphagia 1 year after the initial dilation was approximately 20%, and the probability of not requiring a second dilation was approximately 65% with either technique. Major (esophageal rupture) and minor (bleeding or chest pain) complications occurred in 1% and 5% of the patients and 0.4% and 3% of the total dilation procedures, respectively. The esophageal rupture and four of six minor complications occurred after repeated dilations. Five of the six minor complications occurred with use of the Eder-Puestow dilators. We conclude that Eder-Puestow and balloon dilations of benign esophageal strictures are associated with similar outcomes, but repeated dilations and the Eder-Puestow technique may be associated with an increased risk of complications.

The efficacy of surgical drainage in cervicofacial rhytidectomy: a prospective, randomized, controlled trial.

PubMed

Jones, Barry M; Grover, Rajiv; Hamilton, Stephen

2007-07-01

Postoperative drainage is often used instinctively in face lifting on the assumption that it may reduce the likelihood of complications. This potential benefit should be balanced against cost, discomfort, and the possibility of provoking bleeding and hematoma on removal. Evidence-based decisions on drainage are problematic, since no prospective studies have examined its role. This study was designed to address this issue directly. Fifty consecutive patients undergoing face lift over a 3-month period were randomized to drainage of one side of the face only, with the contralateral side serving as a paired control. Bruising, swelling, and hematoma or seroma were assessed objectively, independently of the operating surgeon and subjectively by the patients. Postoperative hematoma and edema were not influenced by the use of drains (p > 0.5). Patients reported no difference between the two sides with respect to swelling (p = 0.6) or discomfort (p = 0.5). However, drains produced a statistically significant reduction in postoperative bruising both on clinical assessment (p = 0.005) and patient assessment (p = 0.002). This article represents the first prospective, randomized, controlled trial assessing the use of postoperative drainage in facial rejuvenation surgery. Surgical drains do not influence postoperative complications, but they do significantly reduce bruising and so may facilitate the patient's return to normal activity.

Some Effects of Training Preservice Teachers in Science Teaching Strategy Analysis.

ERIC Educational Resources Information Center

Yeany, Russell, Jr.

This study was designed to assess the effectiveness of three treatments for encouraging and training prospective elementary science teachers in the use of inductive/indirect strategies in science teaching. Subjects were randomly assigned to one of four treatment groups: (1) Strategy Analysis Level - subjects were trained in science teaching…

Pediatric Diabetic Ketoacidosis, Fluid Therapy and Cerebral Injury: The Design of a Factorial Randomized Controlled Trial

PubMed Central

Glaser, Nicole S.; Ghetti, Simona; Casper, T. Charles; Dean, J. Michael; Kuppermann, Nathan

2013-01-01

Treatment protocols for pediatric diabetic ketoacidosis (DKA) vary considerably among centers in the United States and worldwide. The optimal protocol for intravenous fluid administration is an area of particular controversy, mainly in regard to possible associations between rates of intravenous fluid infusion and the development of cerebral edema, the most common and most feared complication of DKA in children. Theoretical concerns about associations between osmotic fluid shifts and cerebral edema have prompted recommendations for conservative fluid infusion during DKA. However, recent data suggest that cerebral hypoperfusion may play a role in cerebral injury associated with DKA. Currently there are no existing data from prospective clinical trials to determine the optimal fluid treatment protocol for pediatric DKA. The Pediatric Emergency Care Applied Research Network FLUID (Fluid Therapies Under Investigation in DKA) Study is the first prospective randomized trial to evaluate fluid regimens for pediatric DKA. This 13-center nationwide factorial-design study will evaluate the effects of rehydration rate and fluid sodium content on neurological status during DKA treatment, the frequency of clinically-overt CE, and long-term neurocognitive outcomes following DKA. PMID:23490311

Design and rationale of a prospective, collaborative meta-analysis of all randomized controlled trials of angiotensin receptor antagonists in Marfan syndrome, based on individual patient data: A report from the Marfan Treatment Trialists' Collaboration

PubMed Central

Pitcher, Alex; Emberson, Jonathan; Lacro, Ronald V.; Sleeper, Lynn A.; Stylianou, Mario; Mahony, Lynn; Pearson, Gail D.; Groenink, Maarten; Mulder, Barbara J.; Zwinderman, Aeilko H.; De Backer, Julie; De Paepe, Anne M.; Arbustini, Eloisa; Erdem, Guliz; Jin, Xu Yu; Flather, Marcus D.; Mullen, Michael J.; Child, Anne H.; Forteza, Alberto; Evangelista, Arturo; Chiu, Hsin-Hui; Wu, Mei-Hwan; Sandor, George; Bhatt, Ami B.; Creager, Mark A.; Devereux, Richard B.; Loeys, Bart; Forfar, J. Colin; Neubauer, Stefan; Watkins, Hugh; Boileau, Catherine; Jondeau, Guillaume; Dietz, Harry C.; Baigent, Colin

2015-01-01

Rationale A number of randomized trials are underway, which will address the effects of angiotensin receptor blockers (ARBs) on aortic root enlargement and a range of other end points in patients with Marfan syndrome. If individual participant data from these trials were to be combined, a meta-analysis of the resulting data, totaling approximately 2,300 patients, would allow estimation across a number of trials of the treatment effects both of ARB therapy and of β-blockade. Such an analysis would also allow estimation of treatment effects in particular subgroups of patients on a range of end points of interest and would allow a more powerful estimate of the effects of these treatments on a composite end point of several clinical outcomes than would be available from any individual trial. Design A prospective, collaborative meta-analysis based on individual patient data from all randomized trials in Marfan syndrome of (i) ARBs versus placebo (or open-label control) and (ii) ARBs versus β-blockers will be performed. A prospective study design, in which the principal hypotheses, trial eligibility criteria, analyses, and methods are specified in advance of the unblinding of the component trials, will help to limit bias owing to data-dependent emphasis on the results of particular trials. The use of individual patient data will allow for analysis of the effects of ARBs in particular patient subgroups and for time-to-event analysis for clinical outcomes. The meta-analysis protocol summarized in this report was written on behalf of the Marfan Treatment Trialists' Collaboration and finalized in late 2012, without foreknowledge of the results of any component trial, and will be made available online (http://www.ctsu.ox.ac.uk/research/meta-trials). PMID:25965707

Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials

DOE Office of Scientific and Technical Information (OSTI.GOV)

Logan, Jennifer K.; Tang, Chad; Liao, Zhongxing

Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials inmore » NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.« less

Design of the Revascularization With Open Bypass vs Angioplasty and Stenting of the Lower Extremity Trial (ROBUST): a randomized clinical trial.

PubMed

Malas, Mahmoud B; Qazi, Umair; Glebova, Natalia; Arhuidese, Isibor; Reifsnyder, Thomas; Black, James; Perler, Bruce A; Freischlag, Julie A

2014-12-01

To our knowledge, there is no level 1 evidence comparing open bypass with angioplasty and stenting in TransAtlantic Inter-Society Consensus (TASC II) B and C superficial femoral artery lesions. The Revascularization With Open Bypass vs Angioplasty and Stenting of the Lower Extremity Trial (ROBUST) is the first prospective randomized clinical trial comparing both treatments. To report the design of the ROBUST trial. The primary aim of the trial is to compare (1) the patency rate (primary, primary assisted, and secondary patency at 6 and 12 months), (2) improvement of quality of life, (3) clinical improvement (at least 1 Rutherford category), and (4) wound healing and limb salvage in patients presenting with critical limb ischemia; secondary aims include (1) cost-effectiveness by factoring procedure and hospital admission costs including rehabilitation, readmission, and reintervention costs, (2) amputation-free survival, (3) reintervention rate, and (4) 30-day operative mortality, morbidity, and wound and access complications. ROBUST is a prospective randomized clinical trial with the aim to enroll 320 patients with intermittent claudication that does not respond to medical management and patients with critical limb ischemia. The maximum level of medical therapy will be administered using antiplatelet agents and statins, as well as measures to control hypertension and diabetes mellitus. Patients with TASC II B or C lesions are prospectively randomized to receive either femoropopliteal bypass or percutaneous transluminal angioplasty and stenting; patients with TASC II A and D lesions are not randomized and receive percutaneous transluminal angioplasty and stenting or femoropopliteal bypass, respectively. All patients will be evaluated at 1, 6, and 12 months postoperatively with physical examination, ankle brachial index, duplex, and a quality-of-life questionnaire. The trial is actively enrolling participants. At the time of writing, 29 patients have been enrolled; most are male (60%) and white (65%). Providing level 1 evidence, ROBUST may help to establish guidelines for the treatment of superficial femoral artery lesions, eliminate unnecessary procedures, and reduce health care costs. clinicaltrials.gov Identifier: NCT01602159.

Autologous Skin Cell Spray for Massive Soft Tissue War Injuries: A Prospective, Case-Control, Multicenter Trial

DTIC Science & Technology

2014-04-01

randomization design, after all patients are treated with dermal matrix, patients will be randomized to Arm 1 (control group; standard skin grafting with... grafts are often “meshed” or flattened and spread out to increase the size of the skin graft to better cover a large wound. Standard “meshing” increases...the size of the donor graft by 1.5 times (1:1.5). Problems with healing and skin irritation remain with such skin grafts when the injured areas are

Evaluating the Dissemination of "Body & Soul," an Evidence-based Fruit and Vegetable Intake Intervention: Challenges for Dissemination and Implementation Research

ERIC Educational Resources Information Center

Allicock, Marlyn; Campbell, Marci K.; Valle, Carmina G.; Carr, Carol; Resnicow, Ken; Gizlice, Ziya

2012-01-01

Objective: To evaluate whether the evidence-based "Body & Soul" program, when disseminated and implemented without researcher or agency involvement and support, would achieve results similar to those of earlier efficacy and effectiveness trials. Design: Prospective group randomized trial. Setting: Churches with predominantly African American…

Effect of prospective reimbursement on nursing home costs.

PubMed Central

Coburn, A F; Fortinsky, R; McGuire, C; McDonald, T P

1993-01-01

OBJECTIVE. This study evaluates the effect of Maine's Medicaid nursing home prospective payment system on nursing home costs and access to care for public patients. DATA SOURCES/STUDY SETTING. The implementation of a facility-specific prospective payment system for nursing homes provided the opportunity for longitudinal study of the effect of that system. Data sources included audited Medicaid nursing home cost reports, quality-of-care data from state facility survey and licensure files, and facility case-mix information from random, stratified samples of homes and residents. Data were obtained for six years (1979-1985) covering the three-year period before and after implementation of the prospective payment system. STUDY DESIGN. This study used a pre-post, longitudinal analytical design in which interrupted, time-series regression models were estimated to test the effects of prospective payment and other factors, e.g., facility characteristics, nursing home market factors, facility case mix, and quality of care, on nursing home costs. PRINCIPAL FINDINGS. Prospective payment contributed to an estimated $3.03 decrease in total variable costs in the third year from what would have been expected under the previous retrospective cost-based payment system. Responsiveness to payment system efficiency incentives declined over the study period, however, indicating a growing problem in achieving further cost reductions. Some evidence suggested that cost reductions might have reduced access for public patients. CONCLUSIONS. Study findings are consistent with the results of other studies that have demonstrated the effectiveness of prospective payment systems in restraining nursing home costs. Potential policy trade-offs among cost containment, access, and quality assurance deserve further consideration, particularly by researchers and policymakers designing the new generation of case mix-based and other nursing home payment systems. PMID:8463109

Robotic Surgery Readiness (RSR): A Prospective Randomized Skills Decay Recognition and Prevention Study

DTIC Science & Technology

2016-08-01

AWARD NUMBER: W81XWH-15-2-0030 TITLE: Robotic Surgery Readiness (RSR): A Prospective Randomized Skills Decay Recognition and Prevention Study...20164. TITLE AND SUBTITLE Robotic Surgery Readiness (RSR): A Prospective Randomized Skills Decay 5a. CONTRACT NUMBER R ognition and Prevention Study...be recruited and many have completed the proficiency phase of this project and will be moving on to AIM 1. 15. SUBJECT TERMS Robotic Surgery

Regulatory considerations in the design of comparative observational studies using propensity scores.

PubMed

Yue, Lilly Q

2012-01-01

In the evaluation of medical products, including drugs, biological products, and medical devices, comparative observational studies could play an important role when properly conducted randomized, well-controlled clinical trials are infeasible due to ethical or practical reasons. However, various biases could be introduced at every stage and into every aspect of the observational study, and consequently the interpretation of the resulting statistical inference would be of concern. While there do exist statistical techniques for addressing some of the challenging issues, often based on propensity score methodology, these statistical tools probably have not been as widely employed in prospectively designing observational studies as they should be. There are also times when they are implemented in an unscientific manner, such as performing propensity score model selection for a dataset involving outcome data in the same dataset, so that the integrity of observational study design and the interpretability of outcome analysis results could be compromised. In this paper, regulatory considerations on prospective study design using propensity scores are shared and illustrated with hypothetical examples.

Critical Thinking and Reflection Exercises in a Biochemistry Course to Improve Prospective Health Professions Students’ Attitudes Toward Physician-Pharmacist Collaboration

PubMed Central

Cornell, Susan; Fjortoft, Nancy; Bjork, Bryan C.; Chandar, Nalini; Green, Jacalyn M.; La Salle, Sophie; Viselli, Susan M.; Burdick, Paulette; Lynch, Sean M.

2013-01-01

Objective. To determine the impact of performing critical-thinking and reflection assignments within interdisciplinary learning teams in a biochemistry course on pharmacy students’ and prospective health professions students’ collaboration scores. Design. Pharmacy students and prospective medical, dental, and other health professions students enrolled in a sequence of 2 required biochemistry courses. They were randomly assigned to interdisciplinary learning teams in which they were required to complete case assignments, thinking and reflection exercises, and a team service-learning project. Assessment. Students were asked to complete the Scale of Attitudes Toward Physician-Pharmacist Collaboration prior to the first course, following the first course, and following the second course. The physician-pharmacist collaboration scores of prospective health professions students increased significantly (p<0.001). Conclusions. Having prospective health professions students work in teams with pharmacy students to think and reflect in and outside the classroom improves their attitudes toward physician-pharmacist collaboration. PMID:24159210

The effects of assertiveness training in patients with schizophrenia: a randomized, single-blind, controlled study.

PubMed

Lee, Tso-Ying; Chang, Shih-Chin; Chu, Hsin; Yang, Chyn-Yng; Ou, Keng-Liang; Chung, Min-Huey; Chou, Kuei-Ru

2013-11-01

In this study, we investigated the effects of group assertiveness training on assertiveness, social anxiety and satisfaction with interpersonal communication among patients with chronic schizophrenia. Only limited studies highlighted the effectiveness of group assertiveness training among inpatients with schizophrenia. Given the lack of group assertiveness training among patients with schizophrenia, further development of programmes focusing on facilitating assertiveness, self-confidence and social skills among inpatients with chronic schizophrenia is needed. This study used a prospective, randomized, single-blinded, parallel-group design. This study employed a prospective, randomized, parallel-group design. Seventy-four patients were randomly assigned to experimental group receiving 12 sessions of assertiveness training, or a supportive control group. Data collection took place for the period of June 2009-July 2010. Among patients with chronic schizophrenia, assertiveness, levels of social anxiety and satisfaction with interpersonal communication significantly improved immediately after the intervention and at the 3-month follow-up in the intervention group. The results of a generalized estimating equation (GEE) indicated that: (1) assertiveness significantly improved from pre- to postintervention and was maintained until the follow-up; (2) anxiety regarding social interactions significantly decreased after assertiveness training; and (3) satisfaction with interpersonal communication slightly improved after the 12-session intervention and at the 3-month follow-up. Assertivenss training is a non-invasive and inexpensive therapy that appears to improve assertiveness, social anxiety and interpersonal communication among inpatients with chronic schizophrenia. These findings may provide a reference guide to clinical nurses for developing assertiveness-training protocols. © 2013 Blackwell Publishing Ltd.

Outcome of patients after lower limb fracture with partial weight bearing postoperatively treated with or without anti-gravity treadmill (alter G®) during six weeks of rehabilitation - a protocol of a prospective randomized trial.

PubMed

Henkelmann, Ralf; Schneider, Sebastian; Müller, Daniel; Gahr, Ralf; Josten, Christoph; Böhme, Jörg

2017-03-14

Partial or complete immobilization leads to different adjustment processes like higher risk of muscle atrophy or a decrease of general performance. The present study is designed to prove efficacy of the anti-gravity treadmill (alter G®) compared to a standard rehabilitation protocol in patients with tibial plateau (group 1)or ankle fractures (group 2) with six weeks of partial weight bearing of 20 kg. This prospective randomized study will include a total of 60 patients for each group according to predefined inclusion and exclusion criteria. 1:1 randomization will be performed centrally via fax supported by the Clinical Trial Centre Leipzig (ZKS Leipzig). Patients in the treatment arm will be treated with an anti-gravity treadmill (alter G®) instead of physiotherapy. The protocol is designed parallel to standard physiotherapy with a frequency of two to three times of training with the treadmill per week with duration of 20 min for six weeks. Up to date no published randomized controlled trial with an anti-gravity treadmill is available. The findings of this study can help to modify rehabilitation of patients with partial weight bearing due to their injury or postoperative protocol. It will deliver interesting results if an anti-gravity treadmill is useful in rehabilitation in those patients. Further ongoing studies will identify different indications for an anti-gravity treadmill. Thus, in connection with those studies, a more valid statement regarding safety and efficacy is possible. NCT02790229 registered on May 29, 2016.

The breast reconstruction evaluation of acellular dermal matrix as a sling trial (BREASTrial): design and methods of a prospective randomized trial.

PubMed

Agarwal, Jayant P; Mendenhall, Shaun D; Anderson, Layla A; Ying, Jian; Boucher, Kenneth M; Liu, Ting; Neumayer, Leigh A

2015-01-01

Recent literature has focused on the advantages and disadvantages of using acellular dermal matrix in breast reconstruction. Many of the reported data are from low level-of-evidence studies, leaving many questions incompletely answered. The present randomized trial provides high-level data on the incidence and severity of complications in acellular dermal matrix breast reconstruction between two commonly used types of acellular dermal matrix. A prospective randomized trial was conducted to compare outcomes of immediate staged tissue expander breast reconstruction using either AlloDerm or DermaMatrix. The impact of body mass index, smoking, diabetes, mastectomy type, radiation therapy, and chemotherapy on outcomes was analyzed. Acellular dermal matrix biointegration was analyzed clinically and histologically. Patient satisfaction was assessed by means of preoperative and postoperative surveys. Logistic regression models were used to identify predictors of complications. This article reports on the study design, surgical technique, patient characteristics, and preoperative survey results, with outcomes data in a separate report. After 2.5 years, we successfully enrolled and randomized 128 patients (199 breasts). The majority of patients were healthy nonsmokers, with 41 percent of patients receiving radiation therapy and 49 percent receiving chemotherapy. Half of the mastectomies were prophylactic, with nipple-sparing mastectomy common in both cancer and prophylactic cases. Preoperative survey results indicate that patients were satisfied with their premastectomy breast reconstruction education. Results from the Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial will assist plastic surgeons in making evidence-based decisions regarding acellular dermal matrix-assisted tissue expander breast reconstruction. Therapeutic, II.

Low Social Support Level Is Associated with Non-Adherence to Diet at 1 Year in the Family Intervention Trial for Heart Health (FIT Heart)

ERIC Educational Resources Information Center

Aggarwal, Brooke; Liao, Ming; Allegrante, John P.; Mosca, Lori

2010-01-01

Objective: Evaluate the relationship between low social support (SS) and adherence to diet in a cardiovascular disease (CVD) lifestyle intervention trial. Design: Prospective substudy. Setting and Participants: Blood relatives/cohabitants of hospitalized cardiac patients in a randomized controlled trial (n = 458; 66% female, 35% nonwhite, mean age…

PRotective Effect on the coronary microcirculation of patients with DIabetes by Clopidogrel or Ticagrelor (PREDICT): study rationale and design. A randomized multicenter clinical trial using intracoronary multimodal physiology.

PubMed

Cerrato, Enrico; Quirós, Alicia; Echavarría-Pinto, Mauro; Mejia-Renteria, Hernan; Aldazabal, Andres; Ryan, Nicola; Gonzalo, Nieves; Jimenez-Quevedo, Pilar; Nombela-Franco, Luis; Salinas, Pablo; Núñez-Gil, Iván J; Rumoroso, José Ramón; Fernández-Ortiz, Antonio; Macaya, Carlos; Escaned, Javier

2017-05-19

In diabetic patients a predisposed coronary microcirculation along with a higher risk of distal particulate embolization during primary percutaneous intervention (PCI) increases the risk of peri-procedural microcirculatory damage. However, new antiplatelet agents, in particular Ticagrelor, may protect the microcirculation through its adenosine-mediated vasodilatory effects. PREDICT is an original, prospective, randomized, multicenter controlled study designed to investigate the protective effect of Ticagrelor on the microcirculation during PCI in patient with diabetes mellitus type 2 or pre-diabetic status. The primary endpoints of this study aim to test (i) the decrease in microcirculatory resistance with antiplatelet therapy (Ticagrelor > Clopidogrel; mechanistic effect) and (ii) the relative microcirculatory protection of Ticagrelor compared to Clopidogrel during PCI (Ticagrelor < Clopidogrel; protective effect). PREDICT will be the first multicentre clinical trial to test the adenosine-mediated vasodilatory effect of Ticagrelor on the microcirculation during PCI in diabetic patients. The results will provide important insights into the prospective beneficial effect of this drug in preventing microvascular impairment related to PCI ( http://www.clinicaltrials.gov No. NCT02698618).

Pediatric diabetic ketoacidosis, fluid therapy, and cerebral injury: the design of a factorial randomized controlled trial.

PubMed

Glaser, Nicole S; Ghetti, Simona; Casper, T Charles; Dean, J Michael; Kuppermann, Nathan

2013-09-01

Treatment protocols for pediatric diabetic ketoacidosis (DKA) vary considerably among centers in the USA and worldwide. The optimal protocol for intravenous (IV) fluid administration is an area of particular controversy, mainly in regard to possible associations between rates of IV fluid infusion and the development of cerebral edema (CE), the most common and the most feared complication of DKA in children. Theoretical concerns about associations between osmotic fluid shifts and CE have prompted recommendations for conservative fluid infusion during DKA. However, recent data suggest that cerebral hypoperfusion may play a role in cerebral injury associated with DKA. Currently, there are no existing data from prospective clinical trials to determine the optimal fluid treatment protocol for pediatric DKA. The Pediatric Emergency Care Applied Research Network FLUID (FLuid therapies Under Investigation in DKA) study is the first prospective randomized trial to evaluate fluid regimens for pediatric DKA. This 13-center nationwide factorial design study will evaluate the effects of rehydration rate and fluid sodium content on neurological status during DKA treatment, the frequency of clinically overt CE and long-term neurocognitive outcomes following DKA. © 2013 John Wiley & Sons A/S.

Intradiscal electrothermal therapy used to manage chronic discogenic low back pain: new directions and interventions.

PubMed

Wetzel, F Todd; McNally, Thomas A; Phillips, Frank M

2002-11-15

Retrospective literature review. To review the data on the clinical efficacy of intradiscal electrothermal annuloplasty found at this writing in the peer-reviewed literature to date, to discuss the methodologic strengths and flaws of the studies, to discuss the pitfalls of clinical study designs, to emphasize the need for prospective randomized studies and for increased basic science investigation. Studies published or presented at peer-reviewed societies concerning the clinical efficacy of intradiscal electrothermal annuloplasty are reviewed, including background studies on deafferentation and application of thermal energy to alter biomechanical and structural properties. A proposal for future investigations is presented. Background data from intracapsular annuloplasty highlighting the safety and efficacy of intradiscal electrothermal annuloplasty are presented. Current studies on this procedure, including those in the National Registry are reviewed. All the studies share a common study design: prospective cohort with historical or noninterventional groups used as controls. The patients reviewed are similar. All have nonradicular low back pain of at least 3 months duration, failed conservative care, normal neurologic examination, and MRI showing only nondegenerative disc disease and positive concordant discography. All the patients underwent intradiscal electrothermal annuloplasty lesion at one or two levels according to standard protocols. Follow-up evaluation was performed at various intervals up to 2 years. All the studies used data from a visual analog scale, with most using the Short Form 36 (SF-36) as outcome instruments. The reported follow-up periods for the studies ranged from 6 months to 2 years. Three published studies, one with a 6-month follow-up period and two with a 1-year follow-up period, were published in the peer-reviewed literature. Two recent reports presented to the North American Spine Society were reviewed: a study of patients on a manufacturer-sponsored registry with a 1-year follow-up period and a multicenter prospective cohort study of 75 patients in an intent-to-treat group, with a 1-year follow-up period. Using the 7-point criteria of Deyo et al, all the studies suggested a positive effect of treatment, with a decrease in visual analog scale ratings and improvement in SF-36 scales, particularly those for physical function and bodily pain. The studies published so far suggest that the pain resulting from lumbar disc disease may be diminished by intradiscal electrothermal annuloplasty. All these studies project a positive therapeutic effect. However, all the studies suffer from the same methodologic flaws. A prospective cohort design or a nonrandomized prospective design is used with a biased control. The scientific validity of various study designs is discussed, and a randomized prospective study is recommended. Additionally, more investigation into the basic science of the action of intradiscal electrothermal annuloplasty is required.

Past and Present ARDS Mortality Rates: A Systematic Review.

PubMed

Máca, Jan; Jor, Ondřej; Holub, Michal; Sklienka, Peter; Burša, Filip; Burda, Michal; Janout, Vladimír; Ševčík, Pavel

2017-01-01

ARDS is severe form of respiratory failure with significant impact on the morbidity and mortality of critical care patients. Epidemiological data are crucial for evaluating the efficacy of therapeutic interventions, designing studies, and optimizing resource distribution. The goal of this review is to present general aspects of mortality data published over the past decades. A systematic search of the MEDLINE/PubMed was performed. The articles were divided according to their methodology, type of reported mortality, and time. The main outcome was mortality. Extracted data included study duration, number of patients, and number of centers. The mortality trends and current mortality were calculated for subgroups consisting of in-hospital, ICU, 28/30-d, and 60-d mortality over 3 time periods (A, before 1995; B, 1995-2000; C, after 2000). The retrospectivity and prospectivity were also taken into account. Moreover, we present the most recent mortality rates since 2010. One hundred seventy-seven articles were included in the final analysis. General mortality rates ranged from 11 to 87% in studies including subjects with ARDS of all etiologies (mixed group). Linear regression revealed that the study design (28/30-d or 60-d) significantly influenced the mortality rate. Reported mortality rates were higher in prospective studies, such as randomized controlled trials and prospective observational studies compared with retrospective observational studies. Mortality rates exhibited a linear decrease in relation to time period (P < .001). The number of centers showed a significant negative correlation with mortality rates. The prospective observational studies did not have consistently higher mortality rates compared with randomized controlled trials. The mortality trends over 3 time periods (before 1995, 1995-2000, and after 2000) yielded variable results in general ARDS populations. However, a mortality decrease was present mostly in prospective studies. Since 2010, the overall rates of in-hospital, ICU, and 28/30-d and 60-d mortality were 45, 38, 30, and 32%, respectively. Copyright © 2017 by Daedalus Enterprises.

Efficacy of a Multiplex Paclitaxel Emission Stent Using a Pluronic® Mixture Membrane versus a Covered Metal Stent in Malignant Biliary Obstruction: A Prospective Randomized Comparative Study.

PubMed

Jang, Sung Ill; Lee, Se Joon; Jeong, Seok; Lee, Don Haeng; Kim, Myung-Hwan; Yoon, Hong Jin; Lee, Dong Ki

2017-07-15

A drug-eluting stent for unresectable malignant biliary obstruction was developed to increase stent patency by preventing tumor ingrowth. The safety and efficacy of a new generation of metallic stents covered with a paclitaxel-incorporated membrane using a Pluronic ® mixture (MSCPM-II) were compared prospectively with those of covered metal stents (CMSs) in patients with malignant biliary obstructions. This study was initially designed as a prospective randomized trial but was closed early because of a high incidence of early occlusion. Therefore, the data were analyzed using the intent-to-treat method. A total of 72 patients with unresectable distal malignant biliary obstructions were prospectively enrolled. The two groups did not differ significantly in basic characteristics and mean follow-up period (MSCPM-II 194 days vs CMS 277 days, p=0.063). Stent occlusion occurred in 14 patients (35%) who received MSCPM-II and in seven patients (21.9%) who received CMSs. Stent patency and survival time did not significantly differ between the two groups (p=0.355 and p=0.570). The complications were mild and resolved by conservative management in both groups. There were no significant differences in stent patency or patient survival in MSCPM-II and CMS patients with malignant biliary obstructions.

Fibrin Sealants in Dura Sealing: A Systematic Literature Review

PubMed Central

2016-01-01

Background Fibrin sealants are widely used in neurosurgery to seal the suture line, provide watertight closure, and prevent cerebrospinal fluid leaks. The aim of this systematic review is to summarize the current efficacy and safety literature of fibrin sealants in dura sealing and the prevention/treatment of cerebrospinal fluid leaks. Methods A comprehensive electronic literature search was run in the following databases: Cochrane Database of Systematic Reviews, Cochrane Central Resister of Controlled Trials, clinicaltrials.gov, MEDLINE/PubMed, and EMBASE. Titles and abstracts of potential articles of interest were reviewed independently by 3 of the authors. Results A total of 1006 database records and additional records were identified. After screening for duplicates and relevance, a total of 78 articles were assessed by the investigators for eligibility. Thirty-eight were excluded and the full-text of 40 articles were included in the qualitative synthesis. Seven of these included only safety data and were included in the safety assessment. The remaining 33 articles included findings from 32 studies that enrolled a total of 2935 patients who were exposed to fibrin sealant. Among these 33 studies there were only 3 randomized controlled trials, with the remaining being prospective cohort analysis, case controlled studies, prospective or retrospective case series. One randomized controlled trial, with 89 patients exposed to fibrin sealant, found a greater rate of intraoperative watertight dura closure in the fibrin sealant group than the control group (92.1% versus 38.0%, p<0.001); however, post-operative cerebrospinal fluid leakage occurred in more fibrin sealant than control patients (6.7% versus 2.0%, p>0.05). Other clinical trials evaluated the effect of fibrin sealant in the postoperative prevention of cerebrospinal fluid leaks. These were generally lower level evidence studies (ie, not prospective, randomized, controlled trials) that were not designed or powered to demonstrate a significant advantage to fibrin sealant use. Two small case series studies evaluated the effect of fibrin sealants in persistent cerebrospinal fluid leak treatment, but did not establish firm efficacy conclusions. Specific adverse reports where fibrin sealants were used for dura sealing were limited, with only 8 cases reported in neurosurgical procedures since 1987 and most reporting only a speculative relationship/association with fibrin sealant exposure. Conclusions A major finding of this systematic literature review is that there is a paucity of randomized studies that have evaluated the effectiveness and safety of fibrin sealants in providing intraoperative watertight dura closure and post-operative cerebrospinal fluid leakage. Among the limited studies available, evidence from a single randomized, controlled trial indicates that fibrin sealants provide a higher rate of intraoperative watertight closure of the dura suture line than control, albeit with a higher rate of postoperative cerebrospinal fluid leakage. Evidence from non-randomized, controlled trials suggests that fibrin sealants may be effective in preventing cerebrospinal fluid leaks with an acceptable safety profile. There is a substantial need for randomized, controlled clinical trials or well-designed prospective observational trials where the conduct of a randomized trial is not feasible to fully assess the impact of fibrin sealant utilization on the rates of intraoperative dura closure, postoperative cerebrospinal leakage, and safety. PMID:27119993

Fibrin Sealants in Dura Sealing: A Systematic Literature Review.

PubMed

Esposito, Felice; Angileri, Filippo Flavio; Kruse, Peter; Cavallo, Luigi Maria; Solari, Domenico; Esposito, Vincenzo; Tomasello, Francesco; Cappabianca, Paolo

2016-01-01

Fibrin sealants are widely used in neurosurgery to seal the suture line, provide watertight closure, and prevent cerebrospinal fluid leaks. The aim of this systematic review is to summarize the current efficacy and safety literature of fibrin sealants in dura sealing and the prevention/treatment of cerebrospinal fluid leaks. A comprehensive electronic literature search was run in the following databases: Cochrane Database of Systematic Reviews, Cochrane Central Resister of Controlled Trials, clinicaltrials.gov, MEDLINE/PubMed, and EMBASE. Titles and abstracts of potential articles of interest were reviewed independently by 3 of the authors. A total of 1006 database records and additional records were identified. After screening for duplicates and relevance, a total of 78 articles were assessed by the investigators for eligibility. Thirty-eight were excluded and the full-text of 40 articles were included in the qualitative synthesis. Seven of these included only safety data and were included in the safety assessment. The remaining 33 articles included findings from 32 studies that enrolled a total of 2935 patients who were exposed to fibrin sealant. Among these 33 studies there were only 3 randomized controlled trials, with the remaining being prospective cohort analysis, case controlled studies, prospective or retrospective case series. One randomized controlled trial, with 89 patients exposed to fibrin sealant, found a greater rate of intraoperative watertight dura closure in the fibrin sealant group than the control group (92.1% versus 38.0%, p<0.001); however, post-operative cerebrospinal fluid leakage occurred in more fibrin sealant than control patients (6.7% versus 2.0%, p>0.05). Other clinical trials evaluated the effect of fibrin sealant in the postoperative prevention of cerebrospinal fluid leaks. These were generally lower level evidence studies (ie, not prospective, randomized, controlled trials) that were not designed or powered to demonstrate a significant advantage to fibrin sealant use. Two small case series studies evaluated the effect of fibrin sealants in persistent cerebrospinal fluid leak treatment, but did not establish firm efficacy conclusions. Specific adverse reports where fibrin sealants were used for dura sealing were limited, with only 8 cases reported in neurosurgical procedures since 1987 and most reporting only a speculative relationship/association with fibrin sealant exposure. A major finding of this systematic literature review is that there is a paucity of randomized studies that have evaluated the effectiveness and safety of fibrin sealants in providing intraoperative watertight dura closure and post-operative cerebrospinal fluid leakage. Among the limited studies available, evidence from a single randomized, controlled trial indicates that fibrin sealants provide a higher rate of intraoperative watertight closure of the dura suture line than control, albeit with a higher rate of postoperative cerebrospinal fluid leakage. Evidence from non-randomized, controlled trials suggests that fibrin sealants may be effective in preventing cerebrospinal fluid leaks with an acceptable safety profile. There is a substantial need for randomized, controlled clinical trials or well-designed prospective observational trials where the conduct of a randomized trial is not feasible to fully assess the impact of fibrin sealant utilization on the rates of intraoperative dura closure, postoperative cerebrospinal leakage, and safety.

Clamp-Crushing versus stapler hepatectomy for transection of the parenchyma in elective hepatic resection (CRUNSH) - A randomized controlled trial (NCT01049607)

PubMed Central

2011-01-01

Background Hepatic resection is still associated with significant morbidity. Although the period of parenchymal transection presents a crucial step during the operation, uncertainty persists regarding the optimal technique of transection. It was the aim of the present randomized controlled trial to evaluate the efficacy and safety of hepatic resection using the technique of stapler hepatectomy compared to the simple clamp-crushing technique. Methods/Design The CRUNSH Trial is a prospective randomized controlled single-center trial with a two-group parallel design. Patients scheduled for elective hepatic resection without extrahepatic resection at the Department of General-, Visceral- and Transplantation Surgery, University of Heidelberg are enrolled into the trial and randomized intraoperatively to hepatic resection by the clamp-crushing technique and stapler hepatectomy, respectively. The primary endpoint is total intraoperative blood loss. A set of general and surgical variables are documented as secondary endpoints. Patients and outcome-assessors are blinded for the treatment intervention. Discussion The CRUNSH Trial is the first randomized controlled trial to evaluate efficacy and safety of stapler hepatectomy compared to the clamp-crushing technique for parenchymal transection during elective hepatic resection. Trial Registration ClinicalTrials.gov: NCT01049607 PMID:21888669

REmote SUpervision to Decrease HospitaLization RaTe. Unified and integrated platform for data collected from devices manufactured by different companies: Design and rationale of the RESULT study.

PubMed

Tajstra, Mateusz; Sokal, Adam; Gwóźdź, Arkadiusz; Wilczek, Marcin; Gacek, Adam; Wojciechowski, Konrad; Gadula-Gacek, Elżbieta; Adamowicz-Czoch, Elżbieta; Chłosta-Niepiekło, Katarzyna; Milewski, Krzysztof; Rozentryt, Piotr; Kalarus, Zbigniew; Gąsior, Mariusz; Poloński, Lech

2017-07-01

The number of patients with heart failure implantable cardiac electronic devices (CIEDs) is growing. Hospitalization rate in this group is very high and generates enormous costs. To avoid the need for hospital treatment, optimized monitoring and follow-up is crucial. Remote monitoring (RM) has been widely put into practice in the management of CIEDs but it may be difficult due to the presence of differences in systems provided by device manufacturers and loss of gathered data in case of device reimplantation. Additionally, conclusions derived from studies about usefulness of RM in clinical practice apply to devices coming only from a single company. An integrated monitoring platform allows for more comprehensive data analysis and interpretation. Therefore, the primary objective of Remote Supervision to Decrease Hospitalization Rate (RESULT) study is to evaluate the impact of RM on the clinical status of patients with ICDs or CRT-Ds using an integrated platform. Six hundred consecutive patients with ICDs or CRT-Ds implanted will be prospectively randomized to either a traditional or RM-based follow-up model. The primary clinical endpoint will be a composite of all-cause mortality or hospitalization for cardiovascular reasons within 12 months after randomization. The primary technical endpoint will be to construct and evaluate a unified and integrated platform for the data collected from RM devices manufactured by different companies. This manuscript describes the design and methodology of the prospective, randomized trial designed to determine whether remote monitoring using an integrated platform for different companies is safe, feasible, and efficacious (ClinicalTrials.gov Identifier: NCT02409225). © 2016 Wiley Periodicals, Inc.

Methods for a multicenter randomized trial for mixed urinary incontinence: rationale and patient-centeredness of the ESTEEM trial.

PubMed

Sung, Vivian W; Borello-France, Diane; Dunivan, Gena; Gantz, Marie; Lukacz, Emily S; Moalli, Pamela; Newman, Diane K; Richter, Holly E; Ridgeway, Beri; Smith, Ariana L; Weidner, Alison C; Meikle, Susan

2016-10-01

Mixed urinary incontinence (MUI) can be a challenging condition to manage. We describe the protocol design and rationale for the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM) trial, designed to compare a combined conservative and surgical treatment approach versus surgery alone for improving patient-centered MUI outcomes at 12 months. ESTEEM is a multisite, prospective, randomized trial of female participants with MUI randomized to a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone. We describe our methods and four challenges encountered during the design phase: defining the study population, selecting relevant patient-centered outcomes, determining sample size estimates using a patient-reported outcome measure, and designing an analysis plan that accommodates MUI failure rates. A central theme in the design was patient centeredness, which guided many key decisions. Our primary outcome is patient-reported MUI symptoms measured using the Urogenital Distress Inventory (UDI) score at 12 months. Secondary outcomes include quality of life, sexual function, cost-effectiveness, time to failure, and need for additional treatment. The final study design was implemented in November 2013 across eight clinical sites in the Pelvic Floor Disorders Network. As of 27 February 2016, 433 total/472 targeted participants had been randomized. We describe the ESTEEM protocol and our methods for reaching consensus for methodological challenges in designing a trial for MUI by maintaining the patient perspective at the core of key decisions. This trial will provide information that can directly impact patient care and clinical decision making.

Can Predictive Modeling Identify Head and Neck Oncology Patients at Risk for Readmission?

PubMed

Manning, Amy M; Casper, Keith A; Peter, Kay St; Wilson, Keith M; Mark, Jonathan R; Collar, Ryan M

2018-05-01

Objective Unplanned readmission within 30 days is a contributor to health care costs in the United States. The use of predictive modeling during hospitalization to identify patients at risk for readmission offers a novel approach to quality improvement and cost reduction. Study Design Two-phase study including retrospective analysis of prospectively collected data followed by prospective longitudinal study. Setting Tertiary academic medical center. Subjects and Methods Prospectively collected data for patients undergoing surgical treatment for head and neck cancer from January 2013 to January 2015 were used to build predictive models for readmission within 30 days of discharge using logistic regression, classification and regression tree (CART) analysis, and random forests. One model (logistic regression) was then placed prospectively into the discharge workflow from March 2016 to May 2016 to determine the model's ability to predict which patients would be readmitted within 30 days. Results In total, 174 admissions had descriptive data. Thirty-two were excluded due to incomplete data. Logistic regression, CART, and random forest predictive models were constructed using the remaining 142 admissions. When applied to 106 consecutive prospective head and neck oncology patients at the time of discharge, the logistic regression model predicted readmissions with a specificity of 94%, a sensitivity of 47%, a negative predictive value of 90%, and a positive predictive value of 62% (odds ratio, 14.9; 95% confidence interval, 4.02-55.45). Conclusion Prospectively collected head and neck cancer databases can be used to develop predictive models that can accurately predict which patients will be readmitted. This offers valuable support for quality improvement initiatives and readmission-related cost reduction in head and neck cancer care.

How informative are open-label studies for youth with bipolar disorder? A meta-analysis comparing open-label versus randomized, placebo-controlled clinical trials.

PubMed

Biederman, Joseph; Petty, Carter R; Woodworth, K Yvonne; Lomedico, Alexandra; O'Connor, Katherine B; Wozniak, Janet; Faraone, Stephen V

2012-03-01

To examine the informativeness of open-label trials toward predicting results in subsequent randomized, placebo-controlled clinical trials of psychopharmacologic treatments for pediatric bipolar disorder. We searched journal articles through PubMed at the National Library of Medicine using bipolar disorder, mania, pharmacotherapy, treatment and clinical trial as keywords. This search was supplemented with scientific presentations at national and international scientific meetings and submitted manuscripts from our group. Selection criteria included (1) enrollment of children diagnosed with DSM-IV bipolar disorder; (2) prospective assessment of at least 3 weeks; (3) monotherapy of a pharmacologic treatment for bipolar disorder; (4) use of a randomized placebo-controlled design or an open-label design for the same therapeutic compound; and (5) repeated use of the Young Mania Rating Scale (YMRS) as an outcome. The following information and data were extracted from 14 studies: study design, name of medication, class of medication, dose of medication, sample size, age, sex, trial length, and YMRS mean and standard deviation baseline and follow-up scores. For both study designs, the pooled effect size was statistically significant (open-label studies, z = 8.88, P < .001; randomized placebo-controlled studies, z = 13.75, P < .001), indicating a reduction in the YMRS from baseline to endpoint in both study designs. In a meta-analysis regression, study design was not a significant predictor of mean change in the YMRS. We found similarities in the treatment effects between open-label and randomized placebo-controlled studies in youth with bipolar disorder indicating that open-label studies are useful predictors of the potential safety and efficacy of a given compound in the treatment of pediatric bipolar disorder. © Copyright 2012 Physicians Postgraduate Press, Inc.

[Fitting Monocurve and Bicurve (Soper-McGuire design) rigid gas-permeable contact lenses in keratoconus patients: a prospective randomized comparative clinical trial].

PubMed

Coral-Ghanem, Cleusa; Alves, Milton Ruiz

2008-01-01

To evaluate the clinical performance of Monocurve and Bicurve (Soper-McGuire design) rigid gas-permeable contact lens fitting in patients with keratoconus. A prospective and randomized comparative clinical trial was conducted with a minimum follow-up of six months in two groups of 63 patients. One group was fitted with Monocurve contact lenses and the other with Bicurve Soper-McGuire design. Study variables included fluoresceinic pattern of lens-to-cornea fitting relationship, location and morphology of the cone, presence and degree of punctate keratitis and other corneal surface alterations, topographic changes, visual acuity for distance corrected with contact lenses and survival analysis for remaining with the same contact lens design during the study. During the follow-up there was a decrease in the number of eyes with advanced and central cones fitted with Monocurve lenses, and an increase in those fitted with Soper-McGuire design. In the Monocurve group, a flattening of both the steepest and the flattest keratometric curve was observed. In the Soper-McGuire group, a steepening of the flattest keratometric curve and a flattening of the steepest keratometric curve were observed. There was a decrease in best-corrected visual acuity with contact lens in the Monocurve group. Survival analysis for the Monocurve lens was 60.32% and for the Soper-McGuire was 71.43% at a mean follow-up of six months. This study showed that due to the changes observed in corneal topography, the same contact lens design did not provide an ideal fitting for all patients during the follow-up period. The Soper-McGuire lenses had a better performance than the Monocurve lenses in advanced and central keratoconus.

The WOMEN study: what is the optimal method for ischemia evaluation in women? A multi-center, prospective, randomized study to establish the optimal method for detection of coronary artery disease (CAD) risk in women at an intermediate-high pretest likelihood of CAD: study design.

PubMed

Mieres, Jennifer H; Shaw, Leslee J; Hendel, Robert C; Heller, Gary V

2009-01-01

Coronary artery disease remains the leading cause of morbidity and mortality in women. The optimal non-invasive test for evaluation of ischemic heart disease in women is unknown. Although current guidelines support the choice of the exercise tolerance test (ETT) as a first line test for women with a normal baseline ECG and adequate exercise capabilities, supportive data for this recommendation are controversial. The what is the optimal method for ischemia evaluation in women? (WOMEN) study was designed to determine the optimal non-invasive strategy for CAD risk detection of intermediate and high risk women presenting with chest pain or equivalent symptoms suggestive of ischemic heart disease. The study will prospectively compare the 2-year event rates in women capable of performing exercise treadmill testing or Tc-99 m tetrofosmin SPECT myocardial perfusion imaging (MPI). The study will enroll women presenting for the evaluation of chest pain or anginal equivalent symptoms who are capable of performing >5 METs of exercise while at intermediate-high pretest risk for ischemic heart disease who will be randomized to either ETT testing alone or with Tc-99 m tetrofosmin SPECT MPI. The null hypothesis for this project is that the exercise ECG has the same negative predictive value for risk detection as gated myocardial perfusion SPECT in women. The primary aim is to compare 2-year cardiac event rates in women randomized to SPECT MPI to those randomized to ETT. The WOMEN study seeks to provide objective information for guidelines for the evaluation of symptomatic women with an intermediate-high likelihood for CAD.

Intrapleural chemo- and hyperthermotherapies for malignant pleural effusion: a randomized prospective study.

PubMed

Chen, Wen-Jun; Yuan, Shao-Fei; Yan, Qing-Yuan; Xiong, Jian-Ping; Wang, Sen-Ming; Zheng, Wei-E; Zhang, Wu; Sun, Hong-Yu; Chen, Hua; Wu, Li-Li

2012-02-01

The current prospective randomized study was designed to evaluate the safety and efficacy of combined intrapleural cisplatin and OK-432 (picibanil) plus hyperthermotherapy in patients with malignant pleural effusion (MPE). A total of 358 patients with MPE due to end-stage malignancies were enrolled and randomly divided into two groups, A and B: the intrapleural combination of cisplatin and OK-432 with hyperthermotherapy (n = 179) or without hyperthermotherapy (n = 179), respectively. Mild toxicities such as nausea, vomiting or anorexia, bone marrow depression, and pyrexia were similar in both groups. Patients in Group A (with hyperthermotherapy) showed a significantly higher overall response (93.4%) compared to those in Group B (79.8%, χ(2) = 43.11, p < .05). The median survival time for patients in Group A and Group B were 8.9 and 6.2 months, respectively (p > .05). After treatment, the quality of life scores were significantly increased in both groups as compared to prior treatment (p < .05). In conclusion, our study suggests that combined intrapleural cisplatin and OK-432 followed by hyperthermotherapy are more effective in the control of MPE and improve patients' quality of life.

The Medical Treatment of New-Onset Peripartum Cardiomyopathy: A Systematic Review of Prospective Studies.

PubMed

Desplantie, Olivier; Tremblay-Gravel, Maxime; Avram, Robert; Marquis-Gravel, Guillaume; Ducharme, Anique; Jolicoeur, E Marc

2015-12-01

Peripartum cardiomyopathy (PPCM) is a rare disorder with potentially fatal consequences, which occurs mainly in previously healthy women. The aetiology of PPCM remains unknown and various pathologic mechanisms have been proposed, including immune-mediated injuries and impaired response to oxidative stress and inflammatory cytokines. Several therapies have been studied, but few have been validated in a well-designed randomized controlled trial. In the present study we sought to review the medical treatment intended for acute PPCM. To this end, we performed a systematic review of the literature of randomized and nonrandomized prospective clinical studies. We identified 2 randomized controlled trials that evaluated the dopamine agonist bromocriptine and the inotrope levosimendan, respectively, and 1 nonrandomized study that evaluated the nonselective phosphodiesterase inhibitor pentoxifylline. We reviewed the pathophysiological, pharmacological, and clinical properties for each treatment option identified. Bromocriptine and pentoxifylline both improved left ventricular systolic function and patient-oriented clinical end points and levosimendan did not improve mortality or echocardiographic findings of PPCM. In this review we identified bromocriptine and pentoxifylline, but not levosimendan, as potentially useful agents to improve left ventricle function and outcomes in PPCM. Copyright © 2015 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Detecting ongoing intimate partner violence in the emergency department using a simple 4-question screen: the OVAT.

PubMed

Ernst, Amy A; Weiss, Steven J; Cham, Elaine; Hall, Louise; Nick, Todd G

2004-06-01

We wanted to prospectively evaluate the use of a brief screening tool for ongoing intimate partner violence (IPV), the OVAT, and to validate this tool against the present Index of Spouse Abuse (ISA). The design was a prospective survey during randomized 4-hour shifts in an urban emergency department setting. The scale consists of four questions developed based on our previous work. The ISA was compared as the gold standard for detection of present (ongoing) IPV. Of 362 eligible patients presenting during 75 randomized 4-hour shifts, 306 (85%) completed the study. The prevalence of ongoing IPV using the OVAT was 31% (95% CI 26% to 36%). For the ISA, the prevalence was 20% (95% CI 16% to 25%). Compared with the ISA, the sensitivity of the OVAT in detecting ongoing IPV was 86%, specificity 83%, negative predictive value 96%, positive predictive value 56%, with an accuracy of 84%. In conclusion, four brief questions can detect ongoing IPV to aid in identifying the victim.

Continuous vs. blocks of physiotherapy for motor development in children with cerebral palsy and similar syndromes: A prospective randomized study.

PubMed

Brunner, Anne-Louise; Rutz, Erich; Juenemann, Stephanie; Brunner, Reinald

2014-12-01

To determine whether physiotherapy is more effective when applied in blocks or continuously in children with cerebral palsy (CP). A prospective randomized cross-over design study compared the effect of regular physiotherapy (baseline) with blocks of physiotherapy alternating with no physiotherapy over one year. Thirty-nine institutionalized children with CP and clinically similar syndromes (6-16 years old, Gross Motor Function Classification Scale II-IV) were included. During the first scholastic year, group A received regular physiotherapy, group B blocks of physiotherapy and vice versa in the second year. The Gross Motor Function Measure 66 (GMFM-66) was the outcome measure. Thirteen children in each group completed the study. GMFM-66 improved (p < 0.05) over the study period in both groups in total; changes (p < 0.05) were seen only in dimension D (group B) and E (both groups) during regular therapy. Physiotherapy may be more effective when provided regularly rather than in blocks.

A prospective single-blind randomized-controlled trial comparing two surgical techniques for the treatment of snoring: laser palatoplasty versus uvulectomy with punctate palatal diathermy.

PubMed

Uppal, S; Nadig, S; Jones, C; Nicolaides, A R; Coatesworth, A P

2004-06-01

The aim of this study was to compare laser palatoplasty with uvulectomy with punctate palatal diathermy as treatment modalities for snoring. The study design was a prospective, single-blind, randomized-controlled trial. Eighty-three patients entered the trial. After a mean follow-up period of more than 18 months there was no statistically significant difference between the two groups regarding the patient perception of benefit from surgery or the subjective improvement in snoring. However, there was a statistically significant difference in the degree of pain in the immediate postoperative period (mean difference = 22.14, 95% CI = 7.98-36.31, P = 0.003), with the pain being worse in the laser palatoplasty group. Relative risk of complications for laser palatoplasty was 1.42 (95% CI = 0.93-2.17). The snoring scores and Glasgow Benefit Inventory scores decreased with time in both the groups but there was no statistically significant difference between the two groups.

Peripheral T-cell lymphoma: the role of hematopoietic stem cell transplantation.

PubMed

Gkotzamanidou, Maria; Papadimitriou, Christos A

2014-02-01

Peripheral T-cell lymphoma (PTCL) is a rare and heterogeneous group of non-Hodgkin lymphomas (NHLs). Whereas the incidence of the disease appears to increase during last decades and the prognosis remains dramatically poor, so far no standard treatment has been established. High-dose chemotherapy and autologous stem cell transplantation (HDT-ASCT) has been proven effective in relapsed PTCL, while retrospective studies have shown a survival benefit as first-line treatment in some subsets of PTCL patients. However, given disease rarity, there is a paucity of randomized trials in both upfront and relapse setting. Here, we critically evaluated eligible prospective and retrospective studies that address the role of ASCT in treatment of PTCL, with respect to quality of design and performance. Additionally, the role of allogeneic transplantation has been reviewed. The comparison of ASCT with novel agents that emerge or the combination of both, are to be ascertained via prospective randomized trials in this field. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Prospective randomized trial to assess effects of continuing hormone therapy on cerebral function in postmenopausal women at risk for dementia.

PubMed

Rasgon, Natalie L; Geist, Cheri L; Kenna, Heather A; Wroolie, Tonita E; Williams, Katherine E; Silverman, Daniel H S

2014-01-01

The objective of this study was to examine the effects of estrogen-based hormone therapy (HT) on regional cerebral metabolism in postmenopausal women (mean age = 58, SD = 5) at risk for development of dementia. The prospective clinical trial design included pre- and post-intervention neuroimaging of women randomized to continue (HT+) or discontinue (HT-) therapy following an average of 10 years of use. The primary outcome measure was change in brain metabolism during the subsequent two years, as assessed with fluorodeoxyglucose-18 positron emission tomography (FDG-PET). Longitudinal FDG-PET data were available for 45 study completers. Results showed that women randomized to continue HT experienced relative preservation of frontal and parietal cortical metabolism, compared with women randomized to discontinue HT. Women who discontinued 17-β estradiol (17βE)-based HT, as well as women who continued conjugated equine estrogen (CEE)-based HT, exhibited significant decline in metabolism of the precuneus/posterior cingulate cortical (PCC) area. Significant decline in PCC metabolism was additionally seen in women taking concurrent progestins (with either 17βE or CEE). Together, these findings suggest that among postmenopausal subjects at risk for developing dementia, regional cerebral cortical metabolism is relatively preserved for at least two years in women randomized to continue HT, compared with women randomized to discontinue HT. In addition, continuing unopposed 17βE therapy is associated specifically with preservation of metabolism in PCC, known to undergo the most significant decline in the earliest stages of Alzheimer's disease. ClinicalTrials.gov NCT00097058.

Preventing musculoskeletal injuries among recreational adult volleyball players: design of a randomised prospective controlled trial.

PubMed

Gouttebarge, Vincent; Zwerver, Johannes; Verhagen, Evert

2017-08-02

Both acute and overuse injuries are common among recreational volleyball players, especially finger/wrist, ankle, shoulder and knee injuries. Consequently, an intervention ('VolleyVeilig') was developed to prevent or reduce the occurrence of finger/wrist, shoulder, knee and ankle injuries among recreational volleyball players. This article describes the design of a study evaluating the effectiveness of the developed intervention on the one-season occurrence of finger/wrist, shoulder, knee and ankle injuries among recreational adult volleyball players. A randomized prospective controlled trial with a follow-up period of one volleyball season will be conducted. Participants will be healthy recreational adult volleyball players (18 years of age or older) practicing volleyball (training and/or match) at least twice a week. The intervention ('VolleyVeilig') consists of a warm-up program based on more than 50 distinct exercises (with different variations and levels). The effect of the intervention programme on the occurrence of injuries will be compared to volleyball as usual. Outcome measures will be incidence of acute injury (expressed as number of injuries per 1000 h of play) and prevalence of overuse injuries (expressed as percentage). This study will be one of the first randomized prospective controlled trials evaluating the effectiveness of an intervention on the occurrence of both acute and overuse injuries among recreational adult volleyball players. Outcome of this study could possibly lead to the nationwide implementation of the intervention in all volleyball clubs in The Netherlands, ultimately resulting in less injuries. Dutch Trial Registration NTR6202 , registered February 1st 2017. Version 3, February 2017.

Current challenges for clinical trials of cardiovascular medical devices.

PubMed

Zannad, Faiez; Stough, Wendy Gattis; Piña, Ileana L; Mehran, Roxana; Abraham, William T; Anker, Stefan D; De Ferrari, Gaetano M; Farb, Andrew; Geller, Nancy L; Kieval, Robert S; Linde, Cecilia; Redberg, Rita F; Stein, Kenneth; Vincent, Alphons; Woehrle, Holger; Pocock, Stuart J

2014-07-15

Several features of cardiovascular devices raise considerations for clinical trial conduct. Prospective, randomized, controlled trials remain the highest quality evidence for safety and effectiveness assessments, but, for instance, blinding may be challenging. In order to avoid bias and not confound data interpretation, the use of objective endpoints and blinding patients, study staff, core labs, and clinical endpoint committees to treatment assignment are helpful approaches. Anticipation of potential bias should be considered and planned for prospectively in a cardiovascular device trial. Prospective, single-arm studies (often referred to as registry studies) can provide additional data in some cases. They are subject to selection bias even when carefully designed; thus, they are generally not acceptable as the sole basis for pre-market approval of high risk cardiovascular devices. However, they complement the evidence base and fill the gaps unanswered by randomized trials. Registry studies present device safety and effectiveness in day-to-day clinical practice settings and detect rare adverse events in the post-market period. No single research design will be appropriate for every cardiovascular device or target patient population. The type of trial, appropriate control group, and optimal length of follow-up will depend on the specific device, its potential clinical benefits, the target patient population and the existence (or lack) of effective therapies, and its anticipated risks. Continued efforts on the part of investigators, the device industry, and government regulators are needed to reach the optimal approach for evaluating the safety and performance of innovative devices for the treatment of cardiovascular disease. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Regression discontinuity was a valid design for dichotomous outcomes in three randomized trials.

PubMed

van Leeuwen, Nikki; Lingsma, Hester F; Mooijaart, Simon P; Nieboer, Daan; Trompet, Stella; Steyerberg, Ewout W

2018-06-01

Regression discontinuity (RD) is a quasi-experimental design that may provide valid estimates of treatment effects in case of continuous outcomes. We aimed to evaluate validity and precision in the RD design for dichotomous outcomes. We performed validation studies in three large randomized controlled trials (RCTs) (Corticosteroid Randomization After Significant Head injury [CRASH], the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries [GUSTO], and PROspective Study of Pravastatin in elderly individuals at risk of vascular disease [PROSPER]). To mimic the RD design, we selected patients above and below a cutoff (e.g., age 75 years) randomized to treatment and control, respectively. Adjusted logistic regression models using restricted cubic splines (RCS) and polynomials and local logistic regression models estimated the odds ratio (OR) for treatment, with 95% confidence intervals (CIs) to indicate precision. In CRASH, treatment increased mortality with OR 1.22 [95% CI 1.06-1.40] in the RCT. The RD estimates were 1.42 (0.94-2.16) and 1.13 (0.90-1.40) with RCS adjustment and local regression, respectively. In GUSTO, treatment reduced mortality (OR 0.83 [0.72-0.95]), with more extreme estimates in the RD analysis (OR 0.57 [0.35; 0.92] and 0.67 [0.51; 0.86]). In PROSPER, similar RCT and RD estimates were found, again with less precision in RD designs. We conclude that the RD design provides similar but substantially less precise treatment effect estimates compared with an RCT, with local regression being the preferred method of analysis. Copyright © 2018 Elsevier Inc. All rights reserved.

COMPUTERIZED EXPERT SYSTEM FOR EVALUATION OF AUTOMATED VISUAL FIELDS FROM THE ISCHEMIC OPTIC NEUROPATHY DECOMPRESSION TRIAL: METHODS, BASELINE FIELDS, AND SIX-MONTH LONGITUDINAL FOLLOW-UP

PubMed Central

Feldon, Steven E

2004-01-01

ABSTRACT Purpose To validate a computerized expert system evaluating visual fields in a prospective clinical trial, the Ischemic Optic Neuropathy Decompression Trial (IONDT). To identify the pattern and within-pattern severity of field defects for study eyes at baseline and 6-month follow-up. Design Humphrey visual field (HVF) change was used as the outcome measure for a prospective, randomized, multi-center trial to test the null hypothesis that optic nerve sheath decompression was ineffective in treating nonarteritic anterior ischemic optic neuropathy and to ascertain the natural history of the disease. Methods An expert panel established criteria for the type and severity of visual field defects. Using these criteria, a rule-based computerized expert system interpreted HVF from baseline and 6-month visits for patients randomized to surgery or careful follow-up and for patients who were not randomized. Results A computerized expert system was devised and validated. The system was then used to analyze HVFs. The pattern of defects found at baseline for patients randomized to surgery did not differ from that of patients randomized to careful follow-up. The most common pattern of defect was a superior and inferior arcuate with central scotoma for randomized eyes (19.2%) and a superior and inferior arcuate for nonrandomized eyes (30.6%). Field patterns at 6 months and baseline were not different. For randomized study eyes, the superior altitudinal defects improved (P = .03), as did the inferior altitudinal defects (P = .01). For nonrandomized study eyes, only the inferior altitudinal defects improved (P = .02). No treatment effect was noted. Conclusions A novel rule-based expert system successfully interpreted visual field defects at baseline of eyes enrolled in the IONDT. PMID:15747764

A comparison of the results of prospective and retrospective cohort studies in the field of digestive surgery.

PubMed

Ukai, Tomohiko; Shikata, Satoru; Nakayama, Takeo; Takemura, Yousuke C

2017-07-01

We compared the results of prospective and retrospective cohort studies in the field of digestive surgery to clarify whether the results of prospective cohort studies were more similar to those of randomized controlled trials (RCTs). We conducted a secondary analysis of the results to compare the results of RCTs with those of cohort studies in meta-analyses of 18 digestive surgical topics. The data from the prospective and retrospective cohort studies were combined. The summary estimates of each design were compared with those of RCTs. We used the Z score to investigate discrepancies. Twenty-nine outcomes of 11 topics were investigated in 289 cohort studies (prospective, n = 69; retrospective, n = 220). These were compared with the outcomes of 123 RCTs. In comparison to retrospective studies, the summary estimates of the prospective cohort studies were more similar to those of the RCTs [19/29 (prospective) vs. 10/29 (retrospective), P = 0.035). Five of the 29 outcomes of prospective studies and 6 of 29 outcomes of retrospective studies (P = 0.99) showed significant discrepancies in comparison to RCTs. In the digestive surgical field, the results of prospective cohort studies tended to be more similar to those of RCTs than retrospective studies; however, there were no significant discrepancies between the two types of cohort study.

Regional or general anesthesia for fast-track hip and knee replacement - what is the evidence?

PubMed Central

Kehlet, Henrik; Aasvang, Eske Kvanner

2015-01-01

Regional anesthesia for knee and hip arthroplasty may have favorable outcome effects compared with general anesthesia by effectively blocking afferent input, providing initial postoperative analgesia, reducing endocrine metabolic responses, and providing sympathetic blockade with reduced bleeding and less risk of thromboembolic complications but with undesirable effects on lower limb motor and urinary bladder function. Old randomized studies supported the use of regional anesthesia with fewer postoperative pulmonary and thromboembolic complications, and this has been supported by recent large non-randomized epidemiological database cohort studies. In contrast, the data from newer randomized trials are conflicting, and recent studies using modern general anesthetic techniques may potentially support the use of general versus spinal anesthesia. In summary, the lack of properly designed large randomized controlled trials comparing modern general anesthesia and spinal anesthesia for knee and hip arthroplasty prevents final recommendations and calls for prospective detailed studies in this clinically important field. PMID:26918127

Effect of prospective reimbursement on nursing home costs.

PubMed

Coburn, A F; Fortinsky, R; McGuire, C; McDonald, T P

1993-04-01

This study evaluates the effect of Maine's Medicaid nursing home prospective payment system on nursing home costs and access to care for public patients. The implementation of a facility-specific prospective payment system for nursing homes provided the opportunity for longitudinal study of the effect of that system. Data sources included audited Medicaid nursing home cost reports, quality-of-care data from state facility survey and licensure files, and facility case-mix information from random, stratified samples of homes and residents. Data were obtained for six years (1979-1985) covering the three-year period before and after implementation of the prospective payment system. This study used a pre-post, longitudinal analytical design in which interrupted, time-series regression models were estimated to test the effects of prospective payment and other factors, e.g., facility characteristics, nursing home market factors, facility case mix, and quality of care, on nursing home costs. Prospective payment contributed to an estimated $3.03 decrease in total variable costs in the third year from what would have been expected under the previous retrospective cost-based payment system. Responsiveness to payment system efficiency incentives declined over the study period, however, indicating a growing problem in achieving further cost reductions. Some evidence suggested that cost reductions might have reduced access for public patients. Study findings are consistent with the results of other studies that have demonstrated the effectiveness of prospective payment systems in restraining nursing home costs. Potential policy trade-offs among cost containment, access, and quality assurance deserve further consideration, particularly by researchers and policymakers designing the new generation of case mix-based and other nursing home payment systems.

[Evidence-based quality assessment of 10-year orthodontic clinical trials in 4 major dental journals].

PubMed

Sun, Yan-nan; Lei, Fei-fei; Cao, Yan-li; Fu, Min-kui

2010-02-01

To assess the quality of orthodontic clinical trials published in 4 major dental journals in the past 10 years and establish the reference standard for orthodontic clinical trials and quality control of dental journals. All the clinical trials published in Chinese Journal of Stomatology, West China Journal of Stomatology, Journal of Practice Stomatology and Chinese Journal of Orthodontics from 1999 to 2008 were searched. The demographic information of the papers was extracted and the quality of the clinical trials according to the consolidated standards of reporting trials (CONSORT) was assessed. Four hundred and ninety-four clinical trials were retrieved, and 21.3% (105/494) of them were supported by grants. For the study design, only 26.1% (129/494) were prospective studies, and 3.8% (19/494) were randomized clinical trials. It was hard to evaluate precisely due to the lack of information about the details of the study designs. For the randomized clinical trials, the lack of details for randomization, allocation concealment, blinding and intention to treat compromised the quality. The general quality of clinical trials in orthodontics is poor. It needs to be improved both in the clinical study design and the paper writing.

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

Intravenous levetiracetam vs phenytoin for status epilepticus and cluster seizures: A prospective, randomized study.

PubMed

Gujjar, Arunodaya R; Nandhagopal, Ramachandiran; Jacob, Poovathoor C; Al-Hashim, Abdulhakeem; Al-Amrani, Khalfan; Ganguly, Shyam S; Al-Asmi, Abdullah

2017-07-01

Status Epilepticus (SE) is a common medical emergency carrying a high morbidity and mortality. Levetiracetam (LEV) is a novel anticonvulsant effective against varied seizures. Few prospective studies have addressed its use in SE. We aimed to examine the efficacy of intravenous LEV in controlling SE and cluster attacks of seizures (CS), in comparison with IV phenytoin (DPH), using a prospective, randomized study design. Adult patients with SE or CS, following an initial dose of IV benzodiazepine to control ongoing seizure, were randomized to receive either medication. Rates of seizure control over 24h, adverse effects and outcomes were compared. A logistic regression model was used to identify outcome predictors. 52 patients with SE and 63 with CS received either LEV or DPH. In the SE group, LEV was effective in18/22(82%) and DPH in 22/30(73.3%) patients in controlling seizures. Among patients with CS, LEV was effective in 31/38(81.6%) and DPH in 20/25(80%). With the use of LEV, DPH or both, SE and CS were controlled among 92% and 96% of patients respectively. Adverse events included hypotension (in 2 on DPH) and transient agitation (2 on LEV). IV Levetiracetam controls status epilepticus or cluster seizures with an efficacy comparable to that of phenytoin. Use of these two agents consecutively may control >90% of all such conditions without resort to anaesthetic agents. Further studies should explore its efficacy in larger cohorts of epileptic emergencies. Copyright © 2017 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

A prospective randomized clinical trial to evaluate methods of postoperative care of hypospadias.

PubMed

McLorie, G; Joyner, B; Herz, D; McCallum, J; Bagli, D; Merguerian, P; Khoury, A

2001-05-01

Hypospadias repair is a common operation performed by pediatric urologists. Perhaps the greatest variable and source of controversy of postoperative care is the surgical dressing. We hypothesized that using no dressing would achieve surgically comparable results to those traditionally achieved by a postoperative dressing and it would also simplify postoperative parent delivered home care. Accordingly we designed a prospective randomized clinical trial to compare surgical outcome and postoperative care after hypospadias repair in boys with no dressing and those who received 1 of the 2 most common types of dressing. In a 12-month period 120 boys with an average age of 2.2 years underwent primary 1-stage hypospadias repair at a single center with 4 participating surgeons. Repair was performed in 60 boys with proximal and 60 with distal hypospadias on an outpatient basis. Ethics and Internal Review Board approval, and informed consent were obtained. Boys were then prospectively randomized to receive no dressing, an adhesive biomembrane dressing or a compressive wrap dressing. Comprehensive instructions on postoperative care were distributed to all families and a questionnaire was distributed to the parents at the initial followup. Surgical outcome was evaluated and questionnaire responses were analyzed. Fisher's exact test was done to test the significance of differences in surgical outcomes and questionnaire responses. A total of 117 boys completed the prospective randomized trial. Surgical staff withdrew 3 cases from randomized selection to place a dressing for postoperative hemostasis. We obtained 101 questionnaires for response analysis. The type or absence of the dressing did not correlate with the need for repeat procedures, urethrocutaneous fistula, or meatal stenosis or regression. Analysis revealed less narcotic use in the no dressing group and fewer telephone calls to the urology nurse, or on-call resident and/or fellow. These findings were statistically significant. In addition, there were more unscheduled visits to the urology clinic, emergency room or primary physician office by boys with than without a dressing. Furthermore, 29% of the parents were not psychologically prepared to remove the dressing and 12% were so reluctant that the dressing was removed at the urology outpatient clinic. The surgical outcome and rate of adverse events or complications were not compromised without a postoperative dressing. An absent dressing simplified postoperative ambulatory parent delivered home care. We recommend that dressings should be omitted from routine use after hypospadias repair.

Imposed Power of Breathing Associated With Use of an Impedance Threshold Device

DTIC Science & Technology

2007-02-01

threshold device and a sham impedance threshold device. DESIGN: Prospective randomized blinded protocol. SETTING: University medical center. PATIENTS...for males). METHODS: The volunteers completed 2 trials of breathing through a face mask fitted with an active impedance threshold device set to open...at -7cmH 2 O pressure, or with a sham impedance threshold device, which was identical to the active device except that it did not contain an

Bioactive glass granules: a suitable bone substitute material in the operative treatment of depressed lateral tibial plateau fractures: a prospective, randomized 1 year follow-up study.

PubMed

Heikkilä, Jouni T; Kukkonen, Juha; Aho, Allan J; Moisander, Susanna; Kyyrönen, Timo; Mattila, Kimmo

2011-04-01

Purpose of this study was to compare bioactive glass and autogenous bone as a bone substitute material in tibial plateau fractures. We designed a prospective, randomized study consisting of 25 consecutive operatively treated patients with depressed unilateral tibial comminuted plateau fracture (AO classification 41 B2 and B3).14 patients (7 females, 7 males, mean age 57 years, range 25-82) were randomized in the bioglass group (BG) and 11 patients (6 females, 5 males, mean age 50 years, range 31-82) served as autogenous bone control group (AB). Clinical examination of the patients was performed at 3 and 12 months, patients' subjective and functional results were evaluated at 12 months. Radiological analysis was performed preoperatively, immediately postoperatively and at 3 and 12 months. The postoperative redepression for both studied groups was 1 mm until 3 months and remained unchanged at 12 months. No differences were identified in the subjective evaluation, functional tests and clinical examination between the two groups during 1 year follow-up. We conclude that bioactive glass granules can be clinically used as filler material instead of autogenous bone in the lateral tibial plateau compression fractures.

The Conduct and Reporting of Child Health Research: An Analysis of Randomized Controlled Trials Published in 2012 and Evaluation of Change over 5 Years.

PubMed

Gates, Allison; Hartling, Lisa; Vandermeer, Ben; Caldwell, Patrina; Contopoulos-Ioannidis, Despina G; Curtis, Sarah; Fernandes, Ricardo M; Klassen, Terry P; Williams, Katrina; Dyson, Michele P

2018-02-01

For child health randomized controlled trials (RCTs) published in 2012, we aimed to describe design and reporting characteristics and evaluate changes since 2007; assess the association between trial design and registration and risk of bias (RoB); and assess the association between RoB and effect size. For 300 RCTs, we extracted design and reporting characteristics and assessed RoB. We assessed 5-year changes in design and reporting (based on 300 RCTs we had previously analyzed) using the Fisher exact test. We tested for associations between design and reporting characteristics and overall RoB and registration using the Fisher exact, Cochran-Armitage, Kruskal-Wallis, and Jonckheere-Terpstra tests. We pooled effect sizes and tested for differences by RoB using the χ 2 test for subgroups in meta-analysis. The 2012 and 2007 RCTs differed with respect to many design and reporting characteristics. From 2007 to 2012, RoB did not change for random sequence generation and improved for allocation concealment (P < .001). Fewer 2012 RCTs were rated high overall RoB and more were rated unclear (P = .03). Only 7.3% of 2012 RCTs were rated low overall RoB. Trial registration doubled from 2007 to 2012 (23% to 46%) (P < .001) and was associated with lower RoB (P = .009). Effect size did not differ by RoB (P = .43) CONCLUSIONS: Random sequence generation and allocation concealment were not often reported, and selective reporting was prevalent. Measures to increase trialists' awareness and application of existing reporting guidance, and the prospective registration of RCTs is needed to improve the trustworthiness of findings from this field. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

Prospective Integration of Cultural Consideration in Biomedical Research for Patients with Advanced Cancer: Recommendations from an International Conference on Malignant Bowel Obstruction in Palliative Care

PubMed Central

Fineberg, Iris Cohen; Grant, Marcia; Aziz, Noreen M.; Payne, Richard; Kagawa-Singer, Marjorie; Dunn, Geoffrey P.; Kinzbrunner, Barry M.; Palos, Guadalupe; Shinagawa, Susan Matsuko; Krouse, Robert S.

2007-01-01

In the setting of an international conference on malignant bowel obstruction as a model for randomized control trials (RCT) in palliative care, we discuss the importance of incorporating prospective cultural considerations in research design. The approach commonly used in biomedical research has traditionally valued the RCT as the ultimate “way of knowing” about how to best treat a medical condition. The foremost limitation of this approach is the lack of recognition of the impact of cultural viewpoints on research outcomes. We propose that interest relevant cultural viewpoints should be emphasized in conceptualizing and interpreting research questions, designs, and results. In addition to recognizing our cultural biases as individuals and researchers, we recommend two major shifts in designing and implementing RCTs: a) inclusion of a multidisciplinary team of researchers to inform the diversity of perspectives and expertise brought to the research, and b) use of mixed methods of inquiry, reflecting both deductive and inductive modes of inference. PMID:17532174

Does estrogen play a role in response to adjuvant bone-targeted therapies?

PubMed Central

Russell, Kent; Amir, Eitan; Paterson, Alexander; Josse, Robert; Addison, Christina; Kuchuk, Iryna; Clemons, Mark

2013-01-01

Bone remains the most common site of breast cancer recurrence. The results of population studies, pre-clinical research and clinical studies in patients with metastatic disease provided a rationale for testing bone-targeted agents in the adjuvant setting. Despite the initial optimism, results from eight prospectively designed, randomized control studies powered to assess the value of adjuvant bone-targeted therapy in early breast cancer are conflicting. Data have shown that, where benefit exists, it tends to be in women with a “low estrogen environment”, either through menopause or suppression of ovarian function. In this manuscript, we review clinical data supporting the hypothesis that estrogen levels may play a part in explaining the response of patients to bone-targeted agents in the adjuvant setting. The results presented to date suggest that there may be data supporting a unifying role for estrogen in adjuvant trials. However, in the absence of any prospective randomized trials in which estrogen data has been systematically collected we cannot specifically answer this question. We await the results of the Oxford overview analysis of individual patient data with interest. PMID:26909288

“Decrease in television viewing predicts lower BMI at one year follow up in adolescents but not adults”

PubMed Central

French, Simone A.; Mitchell, Nathan R.; Hannan, Peter J.

2012-01-01

Objective To examine associations between television viewing, sugar-sweetened beverage consumption, eating out, physical activity and body weight change over 1 year. Design Secondary data analysis from randomized intervention trial. Setting Households in the community. Participants Adults (n=153) and adolescents (n=72) from the same households. Intervention(s) Households were randomized to a home-based obesity prevention intervention or to a no-intervention control group for a one-year period. Main Outcome Measure(s) Self-reported television viewing hours, diet and physical activity. Body mass index computed from measured weight and height (primary outcome measure). Analysis Mixed-model regression. Results Among adolescents, a significant prospective association was observed between decreases in television viewing hours and lower BMI z-score at one year follow-up (decreased TV hours: BMI z-score mean = 0.65; no change or increase TV hrs: BMI zscore = 0.92; p < .02). No significant prospective associations were observed among adults. Conclusions and Implications Reducing television viewing may be an effective strategy to prevent excess weight gain among adolescents. PMID:22591582

Evidence-Based Management of Pain After Excisional Haemorrhoidectomy Surgery: A PROSPECT Review Update.

PubMed

Sammour, Tarik; Barazanchi, Ahmed W H; Hill, Andrew G

2017-02-01

The aim of this systematic review was to update previous PROSPECT ( http://www.postoppain.org ) review recommendations for the management of pain after excisional haemorrhoidectomy. Randomized studies and reviews published in the English language from July 2006 (end date of last review) to March 2016, assessing analgesic, anaesthetic, and operative interventions pertaining to excisional haemorrhoidectomy in adults, and reporting pain scores, were retrieved from the EMBASE and MEDLINE databases. An additional 464 studies were identified of which 74 met the inclusion criteria. There were 48 randomized controlled trials and 26 reviews. Quantitative analyses were not performed, as there were limited numbers of trials with a sufficiently homogeneous design. Pudendal nerve block, with or without general anaesthesia, is recommended for all patients undergoing haemorrhoidal surgery. Either closed haemorrhoidectomy, or open haemorrhoidectomy with electrocoagulation of the pedicle is recommended as the primary procedure. Combinations of analgesics (paracetamol, non-steroidal anti-inflammatory drugs, and opioids), topical lignocaine and glyceryl trinitrate, laxatives, and oral metronidazole are recommended post-operatively. The recommendations are largely based on single intervention, not multimodal intervention, studies.

Luteal phase support in intrauterine insemination cycles: a prospective randomized study of 300 mg versus 600 mg intravaginal progesterone tablet.

PubMed

Biberoglu, Ebru H; Tanrıkulu, Filiz; Erdem, Mehmet; Erdem, Ahmet; Biberoglu, Kutay Omer

2016-01-01

Vaginal progesterone (P) has been suggested to be used for luteal phase support (LPS) in controlled ovarian stimulation (COH)-intrauterine insemination (IUI) cycles, however, no concensus exists about the best P dose. Therefore, considering the fecundability rate as the primary end point, our main objective was to find the optimal dose of P in COH-IUI cycles, comparing the two groups of women, each of which comprised of 100 women either on 300 mg or 600 mg of intravaginal P tablets, in a prospective randomized study design. The mean age of the women, duration of infertility, basal and day of hCG injection hormone levels in the female and sperm parameters were similar in the two study groups. Also, duration and dose of gonadotropin given, number of follicles, endometrial thickness, the total, ongoing and multiple pregnancy rates were comparable in both groups. We, therefore, claim that 300 mg of intravaginal micronized P should be the maximum dose of LPS in IUI cycles.

Habitual coffee consumption and risk of cognitive decline/dementia: A systematic review and meta-analysis of prospective cohort studies.

PubMed

Liu, Qing-Ping; Wu, Yan-Feng; Cheng, Hong-Yu; Xia, Tao; Ding, Hong; Wang, Hui; Wang, Ze-Mu; Xu, Yun

2016-06-01

Findings from epidemiologic studies of coffee consumption and risk for cognitive decline or dementia are inconclusive. The aim of this study was to conduct a meta-analysis of prospective studies to assess the association between coffee consumption and the risk for cognitive decline and dementia. Relevant studies were identified by searching PubMed and Embase databases between 1966 and December 2014. Prospective cohorts that reported relative risk (RRs) and 95% confidence intervals (CIs) for the association of coffee consumption with dementia incidence or cognitive changing were eligible. Study-specific RRs were combined by using a random-effects model. Eleven prospective studies, including 29,155 participants, were included in the meta-analysis. The combined RR indicated that high coffee consumption was not associated with the different measures of cognitive decline or dementia (summary RR, 0.97; 95% CI, 0.84-1.11). Subgroup analyses suggested a significant inverse association between highest coffee consumption and the risk for Alzheimer disease (summary RR, 0.73; 95% CI, 0.55-0.97). The dose-response analysis, including eight studies, did not show an association between the increment of coffee intake and cognitive decline or dementia risk (an increment of 1 cup/d of coffee consumed; summary RR, 1.00; 95% CI, 0.98-1.02). The present study suggests that higher coffee consumption is associated with reduced risk for Alzheimer disease. Further randomized controlled trials or well-designed cohort studies are needed to determine the association between coffee consumption and cognitive decline or dementia. Copyright © 2016 Elsevier Inc. All rights reserved.

Soft and Hard Tissue Changes around Tissue-Oriented Tulip-Design Implant Abutments: A 1-Year Randomized Prospective Clinical Trial.

PubMed

Gutmacher, Zvi; Levi, Guy; Blumenfeld, Israel; Machtei, Eli E

2015-10-01

The advantages of platform switching using narrower abutments remain controversial. Many researchers suggest that platform switching can yield enhanced clinical results, while others remain skeptical. We hypothesize that the effectiveness of platform switching might be associated with the degree of reduction in size of the abutment. To radiographically and clinically examine a new abutment design created to move the implant-abutment interface farther medially. This was a prospective, randomized controlled clinical trial that included 27 patients (41 MIS Lance Plus® implants; MIS Implant Technologies, Karmiel, Israel). The patients' age ranged from 39 to 75 years. At the second stage of the surgery, the implants were randomly assigned to either the new platform switch Tulip abutment (TA) design or to the standard platform abutment (SA). Implant probing depth (IPD) and bleeding on probing (BOP) were recorded at baseline and after 12 months. Standardized periapical radiographs were taken (at baseline and at 12 months) and the marginal bone height measured. All implants were successfully integrated. The mean IPD at 1 year post-op was 2.91 mm for the SA group and 2.69 mm for the TA group (p > .05). Similarly, the BOP at 1 year was almost identical in both groups. The mean values of bone resorption at baseline were 0.98 ± 0.37 mm and 0.69 ± 0.20 for the TA and SA groups, respectively (p > .05). Bone loss (baseline to 12 months) was significantly greater in the SA group compared with the TA group. Use of the new TA, with its significantly downsized diameter, resulted in reduced bone loss at 1 year. Further research will be required to assess the long-term effect of this abutment on peri-implant health. © 2014 Wiley Periodicals, Inc.

The rehabilitation of attention in patients with mild cognitive impairment and brain subcortical vascular changes using the Attention Process Training-II. The RehAtt Study: rationale, design and methodology.

PubMed

Salvadori, Emilia; Poggesi, Anna; Valenti, Raffaella; Della Rocca, Eleonora; Diciotti, Stefano; Mascalchi, Mario; Inzitari, Domenico; Pantoni, Leonardo

2016-10-01

Cerebral small vessel disease (SVD) may cause attentional and executive cognitive deficits. No drug is currently available to improve cognitive performance or to prevent dementia in SVD patients, and cognitive rehabilitation could be a promising approach. We aimed to investigate: (1) the effectiveness of the Attention Process Training-II program in the rehabilitation of patients with mild cognitive impairment (MCI) and SVD; (2) the impact of the induced cognitive improvement on functionality and quality of life; (3) the effect of training on brain activity at rest and the possibility of a training-induced plasticity effect. The RehAtt study is designed as a 3-year prospective, single-blinded, randomized clinical trial. Inclusion criteria were: (1) MCI defined according to Winblad et al. criteria; (2) evidence of impairment across attention neuropsychological tests; (3) evidence on MRI of moderate/severe white matter hyperintensities. All enrolled patients are evaluated at baseline, and after 6 and 12 months, according to an extensive clinical, functional, MRI and neuropsychological protocol. The baseline RehAtt cohort includes 44 patients (66 % males, mean ± SD age and years of education 75.3 ± 6.8 and 8.3 ± 4.3, respectively). After baseline assessment, patients have been randomly assigned to 'attention training' or 'standard care'. Treatments and follow-up visits at 6 months are completed, while follow-up visits at 12 months are ongoing. This study is the first attempt to reduce attention deficits in patients affected by MCI with SVD. The results of this pilot experience will represent an essential background for designing larger multicenter, prospective, double-blinded, randomized and controlled clinical trials. NCT02033850 (ClinicalTrials.gov Identifier).

Study design of the CLOSURE I Trial: a prospective, multicenter, randomized, controlled trial to evaluate the safety and efficacy of the STARFlex septal closure system versus best medical therapy in patients with stroke or transient ischemic attack due to presumed paradoxical embolism through a patent foramen ovale.

PubMed

Furlan, Anthony J; Reisman, Mark; Massaro, Joseph; Mauri, Laura; Adams, Harold; Albers, Gregory W; Felberg, Robert; Herrmann, Howard; Kar, Saibal; Landzberg, Michael; Raizner, Albert; Wechsler, Lawrence

2010-12-01

Some strokes of unknown etiology may be the result of a paradoxical embolism traversing through a nonfused foramen ovale (patent foramen ovale [PFO]). The utility of percutaneously placed devices for treatment of patients with cryptogenic stroke or transient ischemic attack (TIA) and PFO is unknown. In addition, there are no clear data about the utility of medical interventions or other surgical procedures in this situation. Despite limited data, many patients are being treated with PFO closure devices. Thus, there is a strong need for clinical trials that test the potential efficacy of PFO occlusive devices in this situation. To address this gap in medical knowledge, we designed the CLOSURE I trial, a randomized, clinical trial comparing the use of a percutaneously placed PFO occlusive device and best medical therapy versus best medical therapy alone for prevention of recurrent ischemic neurologic symptoms among persons with TIA or ischemic stroke. This prospective, multicenter, randomized, controlled trial has finished enrollment. Two-year follow-up for all 910 patients is required. The primary end point is the 2-year incidence of stroke or TIA, all-cause mortality for the first 30 days, and neurologic mortality from ≥ 31 days of follow-up, as adjudicated by a panel of physicians who are unaware of treatment allocation. This article describes the rationale and study design of CLOSURE I. This trial should provide information as to whether the STARFlex septal closure system is safe and more effective than best medical therapy alone in preventing recurrent stroke/TIA and mortality in patients with PFO and whether the STARFlex septal closure device can demonstrate superiority compared with best medical therapy alone. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00201461.

Reduced duration of dual antiplatelet therapy using an improved drug-eluting stent for percutaneous coronary intervention of the left main artery in a real-world, all-comer population: Rationale and study design of the prospective randomized multicenter IDEAL-LM trial.

PubMed

Lemmert, Miguel E; Oldroyd, Keith; Barragan, Paul; Lesiak, Maciej; Byrne, Robert A; Merkulov, Evgeny; Daemen, Joost; Onuma, Yoshinobu; Witberg, Karen; van Geuns, Robert-Jan

2017-05-01

Continuous improvements in stent technology make percutaneous coronary intervention (PCI) a potential alternative to surgery in selected patients with unprotected left main coronary artery (uLMCA) disease. The optimal duration of dual antiplatelet therapy (DAPT) in these patients remains undetermined, and in addition, new stent designs using a bioabsorbable polymer might allow shorter duration of DAPT. IDEAL-LM is a prospective, randomized, multicenter study that will enroll 818 patients undergoing uLMCA PCI. Patients will be randomized in a 1:1 fashion to intravascular ultrasound-guided PCI with the novel everolimus-eluting platinum-chromium Synergy stent with a biodegradable polymer (Boston Scientific, Natick, MA) followed by 4 months of DAPT or the everolimus-eluting cobalt-chromium Xience stent (Abbott Vascular, Santa Clara, CA) followed by 12 months of DAPT. The total follow-up period will be 5 years. A subset of 100 patients will undergo optical coherence tomography at 3 months. The primary end point will be major adverse cardiovascular events (composite of all-cause mortality, myocardial infarction, and ischemia-driven target vessel revascularization) at 2 years. Secondary end points will consist of the individual components of the primary end point, procedural success, a device-oriented composite end point, stent thrombosis as per Academic Research Consortium criteria, and bleeding as per Bleeding Academic Research Consortium criteria. IDEAL-LM is designed to assess the safety and efficacy of the novel Synergy stent followed by 4 months of DAPT vs the Xience stent followed by 12 months of DAPT in patients undergoing uLMCA PCI. The study will provide novel insights regarding optimal treatment strategy for patients undergoing PCI of uLMCA disease (www.clinicaltrials.gov, NCT 02303717). Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

Improving prospective memory in persons with Parkinson disease: A randomized controlled trial

PubMed Central

Foster, Erin R.; McDaniel, Mark A.; Rendell, Peter G.

2017-01-01

Background Prospective memory is essential for productive and independent living and necessary for compliance with prescribed health behaviors. Parkinson disease (PD) can cause prospective memory deficits that are associated with activity limitations and reduced quality of life. Forming implementation intentions is an encoding strategy that may improve prospective memory in this population. Objective To determine the effect of implementation intentions on prospective memory performance in PD. Methods This was a laboratory-based randomized controlled trial. Participants with mild to moderate PD without dementia (N = 62) performed a computerized prospective memory test (Virtual Week) under standard instructions. One week later they were randomly allocated to perform it again while using either implementation intentions or a rehearsal encoding strategy. Results Prospective memory performance was better with the use of both strategies relative to standard instructions. This effect was larger for tasks with event-based compared to time-based cues. In addition, implementation intentions resulted in a larger effect than rehearsal for the non-repeated tasks. Conclusions Strategies that support full encoding of prospective memory cues and actions can improve prospective memory performance among people with PD, particularly for tasks with cues that are readily available in the environment. Implementation intentions may be more effective than rehearsal for non-repeated tasks, but this finding warrants verification. Future work should address transfer of strategy use from the laboratory to everyday life. Targeted strategies to manage prospective memory impairment could improve function and quality of life and significantly impact clinical care for people with PD. (NCT01469741) PMID:28176547

Clinical Evaluation of Kshara sutra Therapy in the management of Bhagandara( Fistula- in-Ano)- A prospective study

PubMed Central

Panigrahi, Hemanta Kumar; Rani, Rakesh; Padhi, M.M.; Lavekar, G.S.

2009-01-01

Study design: A prospective study of 50 patients suffering from Bhagandara(Fistula in Ano) (age ranging from 18-54years) treated by Kshara sutra therapy Place: Kshara sutra unit, Central research Unit, Punjabi bagh, New Delhi Duration: January 2007 to July 2008. Objectives: To determine the incidence of low or high anal fistula, recurrence rate following Kshara sutra therapy and effect of Ksharasutra therapy on the Bhagandara. Material and methods: The fifty patients (50) were selected randomly in the Out Patient Department. Study Design: Uncontrolled open level Study. Results: Patients were followed to see the incidence of recurrence, effect of Kshara Sutra Therapy on incontinence. Overall recurrence rate was only 5.88 %. Minor incontinence was observed only following Kshara sutra Therapy for high variety for which no treatment was given. No such complication occurred in low variety. Conclusion: Bhagandara (Fistula in Ano) can be treated by Kshara Sutra Therapy with minimal loss of sphincter muscle and low reoccurrence rate. PMID:22557318

EARLYDRAIN- outcome after early lumbar CSF-drainage in aneurysmal subarachnoid hemorrhage: study protocol for a randomized controlled trial

PubMed Central

2011-01-01

Background Aneurysmal subarachnoid hemorrhage (SAH) may be complicated by delayed cerebral ischemia, which is a major cause of unfavorable clinical outcome and death in SAH-patients. Delayed cerebral ischemia is presumably related to the development of vasospasm triggered by the presence of blood in the basal cisterns. To date, oral application of the calcium antagonist nimodipine is the only prophylactic treatment for vasospasm recognized under international guidelines. In retrospective trials lumbar drainage of cerebrospinal fluid has been shown to be a safe and feasible measure to remove the blood from the basal cisterns and decrease the incidence of delayed cerebral ischemia and vasospasm in the respective study populations. However, the efficacy of lumbar drainage has not been evaluated prospectively in a randomized controlled trial yet. Methods/Design This is a protocol for a 2-arm randomized controlled trial to compare an intervention group receiving early continuous lumbar CSF-drainage and standard neurointensive care to a control group receiving standard neurointensive care only. Adults suffering from a first aneurysmal subarachnoid hemorrhage whose aneurysm has been secured by means of coiling or clipping are eligible for trial participation. The effect of early CSF drainage (starting < 72 h after securing the aneurysm) will be measured in the following ways: the primary endpoint will be disability after 6 months, assessed by a blinded investigator during a personal visit or standardized telephone interview using the modified Rankin Scale. Secondary endpoints include mortality after 6 months, angiographic vasospasm, transcranial Doppler sonography (TCD) mean flow velocity in both middle cerebral arteries and rate of shunt insertion at 6 months after hospital discharge. Discussion Here, we present the study design of a multicenter prospective randomized controlled trial to investigate whether early application of a lumbar drainage improves clinical outcome after aneurysmal subarachnoid hemorrhage. Trial registration www.clinicaltrials.gov Identifier: NCT01258257 PMID:21917146

Low power and type II errors in recent ophthalmology research.

PubMed

Khan, Zainab; Milko, Jordan; Iqbal, Munir; Masri, Moness; Almeida, David R P

2016-10-01

To investigate the power of unpaired t tests in prospective, randomized controlled trials when these tests failed to detect a statistically significant difference and to determine the frequency of type II errors. Systematic review and meta-analysis. We examined all prospective, randomized controlled trials published between 2010 and 2012 in 4 major ophthalmology journals (Archives of Ophthalmology, British Journal of Ophthalmology, Ophthalmology, and American Journal of Ophthalmology). Studies that used unpaired t tests were included. Power was calculated using the number of subjects in each group, standard deviations, and α = 0.05. The difference between control and experimental means was set to be (1) 20% and (2) 50% of the absolute value of the control's initial conditions. Power and Precision version 4.0 software was used to carry out calculations. Finally, the proportion of articles with type II errors was calculated. β = 0.3 was set as the largest acceptable value for the probability of type II errors. In total, 280 articles were screened. Final analysis included 50 prospective, randomized controlled trials using unpaired t tests. The median power of tests to detect a 50% difference between means was 0.9 and was the same for all 4 journals regardless of the statistical significance of the test. The median power of tests to detect a 20% difference between means ranged from 0.26 to 0.9 for the 4 journals. The median power of these tests to detect a 50% and 20% difference between means was 0.9 and 0.5 for tests that did not achieve statistical significance. A total of 14% and 57% of articles with negative unpaired t tests contained results with β > 0.3 when power was calculated for differences between means of 50% and 20%, respectively. A large portion of studies demonstrate high probabilities of type II errors when detecting small differences between means. The power to detect small difference between means varies across journals. It is, therefore, worthwhile for authors to mention the minimum clinically important difference for individual studies. Journals can consider publishing statistical guidelines for authors to use. Day-to-day clinical decisions rely heavily on the evidence base formed by the plethora of studies available to clinicians. Prospective, randomized controlled clinical trials are highly regarded as a robust study and are used to make important clinical decisions that directly affect patient care. The quality of study designs and statistical methods in major clinical journals is improving overtime, 1 and researchers and journals are being more attentive to statistical methodologies incorporated by studies. The results of well-designed ophthalmic studies with robust methodologies, therefore, have the ability to modify the ways in which diseases are managed. Copyright © 2016 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study.

PubMed

Rahbar, Mohammad H; Fox, Erin E; del Junco, Deborah J; Cotton, Bryan A; Podbielski, Jeanette M; Matijevic, Nena; Cohen, Mitchell J; Schreiber, Martin A; Zhang, Jiajie; Mirhaji, Parsa; Duran, Sarah J; Reynolds, Robert J; Benjamin-Garner, Ruby; Holcomb, John B

2012-04-01

Early death due to hemorrhage is a major consequence of traumatic injury. Transfusion practices differ among hospitals and it is unknown which transfusion practices improve survival. This report describes the experience of the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study Data Coordination Center in designing and coordinating a study to examine transfusion practices at ten Level 1 trauma centers in the US. PROMMTT was a multisite prospective observational study of severely injured transfused trauma patients. The clinical sites collected real-time information on the timing and amounts of blood product infusions as well as colloids and crystalloids, vital signs, initial diagnostic and clinical laboratory tests, life saving interventions and other clinical care data. Between July 2009 and October 2010, PROMMTT screened 12,561 trauma admissions and enrolled 1245 patients who received one or more blood transfusions within 6h of Emergency Department (ED) admission. A total of 297 massive transfusions were observed over the course of the study at a combined rate of 5.0 massive transfusion patients/week. PROMMTT is the first multisite study to collect real-time prospective data on trauma patients requiring transfusion. Support from the Department of Defense and collaborative expertise from the ten participating centers helped to demonstrate the feasibility of prospective trauma transfusion studies. The observational data collected from this study will be an invaluable resource for research in trauma surgery and it will guide the design and conduct of future randomized trials. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study

PubMed Central

Rahbar, Mohammad H.; Fox, Erin E.; del Junco, Deborah J.; Cotton, Bryan A.; Podbielski, Jeanette M.; Matijevic, Nena; Cohen, Mitchell J.; Schreiber, Martin A.; Zhang, Jiajie; Mirhaji, Parsa; Duran, Sarah; Reynolds, Robert J.; Benjamin-Garner, Ruby; Holcomb, John B.

2011-01-01

Aim Early death due to hemorrhage is a major consequence of traumatic injury. Transfusion practices differ among hospitals and it is unknown which transfusion practices improve survival. This report describes the experience of the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study Data Coordination Center in designing and coordinating a study to examine transfusion practices at ten Level 1 trauma centers in the U.S. Methods PROMMTT was a multisite prospective observational study of severely injured transfused trauma patients. The clinical sites collected real-time information on the timing and amounts of blood product infusions as well as colloids and crystalloids, vital signs, initial diagnostic and clinical laboratory tests, life saving interventions and other clinical care data. Results Between July 2009 and October 2010, PROMMTT screened 12,561 trauma admissions and enrolled 1,245 patients who received one or more blood transfusions within 6 hours of ED admission. A total of 297 massive transfusions were observed over the course of the study at a combined rate of 5.0 massive transfusion patients/week. Conclusion PROMMTT is the first multisite study to collect real-time prospective data on trauma patients requiring transfusion. Support from the Department of Defense and collaborative expertise from the ten participating centers helped to demonstrate the feasibility of prospective trauma transfusion studies. The observational data collected from this study will be an invaluable resource for research in trauma surgery and it will guide the design and conduct of future randomized trials. PMID:22001613

Fast track multi-discipline treatment (FTMDT trial) versus conventional treatment in colorectal cancer--the design of a prospective randomized controlled study

PubMed Central

2011-01-01

Background Laparoscopy-assisted surgery, fast-track perioperative treatment are both increasingly used in colorectal cancer treatment, for their short-time benefits of enhanced recovery and short hospital stays. However, the benefits of the integration of the Laparoscopy-assisted surgery, fast-track perioperative treatment, and even with the Xelox chemotherapy, are still unknown. In this study, the three treatments integration is defined as "Fast Track Multi-Discipline Treatment Model" for colorectal cancer and this model extends the benefits to the whole treatment process of colorectal cancer. The main purpose of the study is to explore the feasibility of "Fast Track Multi-Discipline Treatment" model in treatment of colorectal cancer. Methods The trial is a prospective randomized controlled study with 2 × 2 balanced factorial design. Patients eligible for the study will be randomized to 4 groups: (I) Laparoscopic surgery with fast track perioperative treatment and Xelox chemotherapy; (II) Open surgery with fast track perioperative treatment and Xelox chemotherapy; (III) Laparoscopic surgery with conventional perioperative treatment and mFolfox6 chemotherapy; (IV) Open surgery with conventional perioperative treatment and mFolfox6 chemotherapy. The primary endpoint of this study is the hospital stays. The secondary endpoints are the quality of life, chemotherapy related adverse events, surgical complications and hospitalization costs. Totally, 340 patients will be enrolled with 85 patients in each group. Conclusions The study initiates a new treatment model "Fast Track Multi-Discipline Treatment" for colorectal cancer, and will provide feasibility evidence on the new model "Fast Track Multi-Discipline Treatment" for patients with colorectal cancer. Trial registration ClinicalTrials.gov: NCT01080547 PMID:22111914

Comparison of intra-articular injections of hyaluronic acid and corticosteroid in the treatment of osteoarthritis of the hip in comparison with intra-articular injections of bupivacaine. Design of a prospective, randomized, controlled study with blinding of the patients and outcome assessors.

PubMed

Colen, Sascha; van den Bekerom, Michel P J; Bellemans, Johan; Mulier, Michiel

2010-11-16

Although intra-articular hyaluronic acid is well established as a treatment for osteoarthritis of the knee, its use in hip osteoarthritis is not based on large randomized controlled trials. There is a need for more rigorously designed studies on hip osteoarthritis treatment as this subject is still very much under debate. Randomized, controlled trial with a three-armed, parallel-group design. Approximately 315 patients complying with the inclusion and exclusion criteria will be randomized into one of the following treatment groups: infiltration of the hip joint with hyaluronic acid, with a corticosteroid or with 0.125% bupivacaine.The following outcome measure instruments will be assessed at baseline, i.e. before the intra-articular injection of one of the study products, and then again at six weeks, 3 and 6 months after the initial injection: Pain (100 mm VAS), Harris Hip Score and HOOS, patient assessment of their clinical status (worse, stable or better then at the time of enrollment) and intake of pain rescue medication (number per week). In addition patients will be asked if they have complications/adverse events. The six-month follow-up period for all patients will begin on the date the first injection is administered. This randomized, controlled, three-arm study will hopefully provide robust information on two of the intra-articular treatments used in hip osteoarthritis, in comparison to bupivacaine. NCT01079455.

Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term non-steroidal anti-inflammatory drug (NSAID) therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial.

PubMed

Sugano, Kentaro; Kontani, Teiji; Katsuo, Shinichi; Takei, Yoshinori; Sakaki, Nobuhiro; Ashida, Kiyoshi; Mizokami, Yuji; Asaka, Masahiro; Matsui, Shigeyuki; Kanto, Tatsuya; Soen, Satoshi; Takeuchi, Tsutomu; Hiraishi, Hideyuki; Hiramatsu, Naoki

2012-05-01

Low-dose lansoprazole has not been intensively evaluated for its efficacy in the prevention of recurrent gastric or duodenal ulcers in patients receiving long-term non-steroidal anti-inflammatory drug (NSAID) therapy for pain relief in such diseases as rheumatoid arthritis, osteoarthritis, and low back pain. This multi-center, prospective, double-blind, randomized, active-controlled study involving 99 sites in Japan was designed to compare the efficacy of lansoprazole (15 mg daily) with gefarnate (50 mg twice daily). Patients with a history of gastric or duodenal ulcers who required long-term NSAID therapy were randomized to receive lansoprazole 15 mg daily (n = 185) or gefarnate 50 mg twice daily (n = 181) and followed up for 12 months or longer prospectively. The cumulative incidence of gastric or duodenal ulcer at days 91, 181, and 361 from the start of the study was calculated by the Kaplan-Meier method as 3.3, 5.9, and 12.7%, respectively, in the lansoprazole group versus 18.7, 28.5, and 36.9%, respectively, in the gefarnate group. The risk for ulcer development was significantly (log-rank test, P < 0.0001) lower in the lansoprazole group than in the gefarnate group, with the hazard ratio being 0.2510 (95% CI 0.1400-0.4499). A long-term follow-up study showed an acceptable safety profile for low-dose lansoprazole therapy, with diarrhea as the most frequent adverse event. Lansoprazole was superior to gefarnate in reducing the risk of gastric or duodenal ulcer recurrence in patients with a definite history of gastric or duodenal ulcers who required long-term NSAID therapy.

Rationale and design of the GUIDE-IT study: Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.

PubMed

Felker, G Michael; Ahmad, Tariq; Anstrom, Kevin J; Adams, Kirkwood F; Cooper, Lawton S; Ezekowitz, Justin A; Fiuzat, Mona; Houston-Miller, Nancy; Januzzi, James L; Leifer, Eric S; Mark, Daniel B; Desvigne-Nickens, Patrice; Paynter, Gayle; Piña, Ileana L; Whellan, David J; O'Connor, Christopher M

2014-10-01

The GUIDE-IT (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure) study is designed to determine the safety, efficacy, and cost-effectiveness of a strategy of adjusting therapy with the goal of achieving and maintaining a target N-terminal pro-B-type natriuretic peptide (NT-proBNP) level of <1,000 pg/ml compared with usual care in high-risk patients with systolic heart failure (HF). Elevations in natriuretic peptide (NP) levels provide key prognostic information in patients with HF. Therapies proven to improve outcomes in patients with HF are generally associated with decreasing levels of NPs, and observational data show that decreases in NP levels over time are associated with favorable outcomes. Results from smaller prospective, randomized studies of this strategy thus far have been mixed, and current guidelines do not recommend serial measurement of NP levels to guide therapy in patients with HF. GUIDE-IT is a prospective, randomized, controlled, unblinded, multicenter clinical trial designed to randomize approximately 1,100 high-risk subjects with systolic HF (left ventricular ejection fraction ≤40%) to either usual care (optimized guideline-recommended therapy) or a strategy of adjusting therapy with the goal of achieving and maintaining a target NT-proBNP level of <1,000 pg/ml. Patients in either arm of the study are followed up at regular intervals and after treatment adjustments for a minimum of 12 months. The primary endpoint of the study is time to cardiovascular death or first hospitalization for HF. Secondary endpoints include time to cardiovascular death and all-cause mortality, cumulative mortality, health-related quality of life, resource use, cost-effectiveness, and safety. The GUIDE-IT study is designed to definitively assess the effects of an NP-guided strategy in high-risk patients with systolic HF on clinically relevant endpoints of mortality, hospitalization, quality of life, and medical resource use. (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure [GUIDE-IT]; NCT01685840). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Current Status of Renal Denervation in Hypertension.

PubMed

Briasoulis, Alexander; Bakris, George L

2016-11-01

Over the past 7 years, prospective cohorts and small randomized controlled studies showed that renal denervation therapy (RDN) in patients with resistant hypertension is safe but associated with variable effects on BP which are not substantially better than medical therapy alone. The failure of the most rigorously designed randomized sham-control study, SYMPLICITY HTN-3, to meet the efficacy endpoints has raised several methodological concerns. However, recently reported studies and ongoing trials with improved procedural characteristics, identification of patients with true treatment-resistant hypertension on appropriate antihypertensive regimens further explore potential benefits of RDN. The scope of this review is to summarize evidence from currently completed studies on RDN and discuss future perspectives of RDN therapy in patients with resistant hypertension.

Recent advances in the treatment of air leaks.

PubMed

Cerfolio, Robert James

2005-07-01

Alveolar-pleural fistulas (air leaks) are an extremely common clinical problem and remain the most common complication after elective pulmonary resection and video-assisted procedures. The decision making process used to manage air leaks and chest tubes that control them has been, until very recently, based on opinions and training preferences as opposed to facts derived from randomized clinical trials. Recently, several prospective randomized trials have studied air leaks. An objective, reproducible classification system has also been designed and clinically validated to help study air leaks. This system and these studies have shown that water seal is superior to wall suction to help stop most leaks. Even in patients with a pneumothorax and an air leak, water seal is safe and best; however, if a patient has a large leak (greater than an expiratory 3 on the classification system) or experiences subcutaneous emphysema or an expanding pneumothorax that causes hypoxia, then some suction (-10 cm of water) should be applied to the chest tubes. Air leaks were a poorly understood yet extremely common clinical problem that had never been scientifically studied. Over the past 5 years, prospective randomized studies have shown that water seal is the best setting for chest tubes and that a pneumothorax is not a contraindication to leaving tubes on seal. Further studies are needed to investigate the ideal management of alveolar-pleural fistulas (air leaks) in different clinical scenarios besides those that occur postoperatively.

A Prospective Randomized Trial of Postural Changes vs Passive Supine Lying during the Second Stage of Labor under Epidural Analgesia

PubMed Central

Simarro, María; Espinosa, José Angel; Salinas, Cecilia; Ojea, Ricardo; Salvadores, Paloma; Walker, Carolina; Schneider, José

2017-01-01

There exist very few studies comparing different postures or postural changes during labor in parturients with epidural analgesia. Aim: To disclose whether the intervention of a multidisciplinary nursing team including a physiotherapist during the second stage of labor improves the obstetric outcome in parturients with epidural analgesia. Design: Prospective randomized trial. Setting: University-affiliated hospital. Population: Women undergoing labor with epidural analgesia after a normal gestation. Methods: 150 women were randomized either to actively perform predefined postural changes during the passive phase of the second stage of labor under the guidance of the attending physiotherapist (study group), or to carry out the whole second stage of labor lying in the traditional supine position (control group). Results: There were significantly more eutocic deliveries (p = 0.005) and, conversely, significantly less instrumental deliveries (p < 0.05) and cesarean sections (p < 0.05) in the study group. The total duration of the second stage of labor was significantly shorter (p < 0.01) in the study group. This was at the expense of the passive phase of the second stage of labor (p < 0.01). Significantly less episiotomies were performed in the study group (31.2% vs 17.8%, p < 0.05). Conclusion: The intervention of a physiotherapist during the second stage of labor significantly improved the obstetric outcome. PMID:29099021

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

Evolutionary engineering for industrial microbiology.

PubMed

Vanee, Niti; Fisher, Adam B; Fong, Stephen S

2012-01-01

Superficially, evolutionary engineering is a paradoxical field that balances competing interests. In natural settings, evolution iteratively selects and enriches subpopulations that are best adapted to a particular ecological niche using random processes such as genetic mutation. In engineering desired approaches utilize rational prospective design to address targeted problems. When considering details of evolutionary and engineering processes, more commonality can be found. Engineering relies on detailed knowledge of the problem parameters and design properties in order to predict design outcomes that would be an optimized solution. When detailed knowledge of a system is lacking, engineers often employ algorithmic search strategies to identify empirical solutions. Evolution epitomizes this iterative optimization by continuously diversifying design options from a parental design, and then selecting the progeny designs that represent satisfactory solutions. In this chapter, the technique of applying the natural principles of evolution to engineer microbes for industrial applications is discussed to highlight the challenges and principles of evolutionary engineering.

Empiric versus imaging guided left ventricular lead placement in cardiac resynchronization therapy (ImagingCRT): study protocol for a randomized controlled trial.

PubMed

Sommer, Anders; Kronborg, Mads Brix; Poulsen, Steen Hvitfeldt; Böttcher, Morten; Nørgaard, Bjarne Linde; Bouchelouche, Kirsten; Mortensen, Peter Thomas; Gerdes, Christian; Nielsen, Jens Cosedis

2013-04-26

Cardiac resynchronization therapy (CRT) is an established treatment in heart failure patients. However, a large proportion of patients remain nonresponsive to this pacing strategy. Left ventricular (LV) lead position is one of the main determinants of response to CRT. This study aims to clarify whether multimodality imaging guided LV lead placement improves clinical outcome after CRT. The ImagingCRT study is a prospective, randomized, patient- and assessor-blinded, two-armed trial. The study is designed to investigate the effect of imaging guided left ventricular lead positioning on a clinical composite primary endpoint comprising all-cause mortality, hospitalization for heart failure, or unchanged or worsened functional capacity (no improvement in New York Heart Association class and <10% improvement in six-minute-walk test). Imaging guided LV lead positioning is targeted to the latest activated non-scarred myocardial region by speckle tracking echocardiography, single-photon emission computed tomography, and cardiac computed tomography. Secondary endpoints include changes in LV dimensions, ejection fraction and dyssynchrony. A total of 192 patients are included in the study. Despite tremendous advances in knowledge with CRT, the proportion of patients not responding to this treatment has remained stable since the introduction of CRT. ImagingCRT is a prospective, randomized study assessing the clinical and echocardiographic effect of multimodality imaging guided LV lead placement in CRT. The results are expected to make an important contribution in the pursuit of increasing response rate to CRT. Clinicaltrials.gov identifier NCT01323686. The trial was registered March 25, 2011 and the first study subject was randomized April 11, 2011.

The role of vitamin D in the prevention of late-life depression.

PubMed

Okereke, Olivia I; Singh, Ankura

2016-07-01

In this article, we review current evidence regarding potential benefits of vitamin D for improving mood and reducing depression risk in older adults. We summarize gaps in knowledge and describe future efforts that may clarify the role of vitamin D in late-life depression prevention. MEDLINE and PsychINFO databases were searched for all articles on vitamin D and mood that had been published up to and including May 2015. Observational studies and randomized trials with 50 or more participants were included. We excluded studies that involved only younger adults and/or exclusively involved persons with current depression. Twenty observational (cross-sectional and prospective) studies and 10 randomized trials (nine were randomized placebo-controlled trials [RCTs]; one was a randomized blinded comparison trial) were reviewed. Inverse associations of vitamin D blood level or vitamin D intake with depression were found in 13 observational studies; three identified prospective relations. Results from all but one of the RCTs showed no statistically significant differences in depression outcomes between vitamin D and placebo groups. Observational studies were mostly cross-sectional and frequently lacked adequate control of confounding. RCTs often featured low treatment doses, suboptimal post-intervention changes in biochemical levels of vitamin D, and/or short trial durations. Vitamin D level-mood associations were observed in most, but not all, observational studies; results indicated that vitamin D deficiency may be a risk factor for late-life depression. However, additional data from well-designed RCTs are required to determine the impact of vitamin D in late-life depression prevention. Copyright © 2016 Elsevier B.V. All rights reserved.

Comparison of 3 biodegradable polymer and durable polymer-based drug-eluting stents in all-comers (BIO-RESORT): rationale and study design of the randomized TWENTE III multicenter trial.

PubMed

Lam, Ming Kai; Sen, Hanim; Tandjung, Kenneth; van Houwelingen, K Gert; de Vries, Arie G; Danse, Peter W; Schotborgh, Carl E; Scholte, Martijn; Löwik, Marije M; Linssen, Gerard C M; Ijzerman, Maarten J; van der Palen, Job; Doggen, Carine J M; von Birgelen, Clemens

2014-04-01

To evaluate the safety and efficacy of 2 novel drug-eluting stents (DES) with biodegradable polymer-based coatings versus a durable coating DES. BIO-RESORT is an investigator-initiated, prospective, patient-blinded, randomized multicenter trial in 3540 Dutch all-comers with various clinical syndromes, requiring percutaneous coronary interventions (PCI) with DES implantation. Randomization (stratified for diabetes mellitus) is being performed in a 1:1:1 ratio between ORSIRO sirolimus-eluting stent with circumferential biodegradable coating, SYNERGY everolimus-eluting stent with abluminal biodegradable coating, and RESOLUTE INTEGRITY zotarolimus-eluting stent with durable coating. The primary endpoint is the incidence of the composite endpoint target vessel failure at 1 year, consisting of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization. Power calculation assumes a target vessel failure rate of 8.5% with a 3.5% non-inferiority margin, giving the study a power of 85% (α level .025 adjusted for multiple testing). The impact of diabetes mellitus on post-PCI outcome will be evaluated. The first patient was enrolled on December 21, 2012. BIO-RESORT is a large, prospective, randomized, multicenter trial with three arms, comparing two DES with biodegradable coatings versus a reference DES with a durable coating in 3540 all-comers. The trial will provide novel insights into the clinical outcome of modern DES and will address the impact of known and so far undetected diabetes mellitus on post-PCI outcome. Copyright © 2014 The Authors. Published by Mosby, Inc. All rights reserved.

PROspective Multicenter Imaging Study for Evaluation of chest pain: rationale and design of the PROMISE trial.

PubMed

Douglas, Pamela S; Hoffmann, Udo; Lee, Kerry L; Mark, Daniel B; Al-Khalidi, Hussein R; Anstrom, Kevin; Dolor, Rowena J; Kosinski, Andrzej; Krucoff, Mitchell W; Mudrick, Daniel W; Patel, Manesh R; Picard, Michael H; Udelson, James E; Velazquez, Eric J; Cooper, Lawton

2014-06-01

Suspected coronary artery disease (CAD) is one of the most common, potentially life-threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients. The PROMISE study is a prospective, randomized trial comparing the effectiveness of 2 initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either (1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram) or (2) anatomical testing with ≥64-slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians, and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core laboratory quality and completeness assessment. All subjects are followed up for ≥1 year. The primary end point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis, and renal failure), or hospitalization for unstable angina. More than 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care, and anesthesiology sites. Multispecialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. The PROMISE trial will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomical testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost-effectiveness, and radiation exposure will be assessed. Copyright © 2014 Mosby, Inc. All rights reserved.

PROspective Multicenter Imaging Study for Evaluation of Chest Pain: Rationale and Design of the PROMISE Trial

PubMed Central

Douglas, Pamela S.; Hoffmann, Udo; Lee, Kerry L.; Mark, Daniel B.; Al-Khalidi, Hussein R.; Anstrom, Kevin; Dolor, Rowena J.; Kosinski, Andrzej; Krucoff, Mitchell W.; Mudrick, Daniel W.; Patel, Manesh R.; Picard, Michael H.; Udelson, James E.; Velazquez, Eric J.; Cooper, Lawton

2014-01-01

Background Suspected coronary artery disease (CAD) is one of the most common, potentially life threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients. Methods The PROMISE study is a prospective, randomized trial comparing the effectiveness of two initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either: 1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram); or 2) anatomic testing with >=64 slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core lab quality and completeness assessment. All subjects are followed for ≥1 year. The primary end-point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis and renal failure) or hospitalization for unstable angina. Results Over 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care and anesthesiology sites. Conclusion Multi-specialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. PROMISE will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomic testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost effectiveness and radiation exposure will be assessed. Clinical trials.gov identifier NCT01174550 PMID:24890527

Progress and problems for randomized clinical trials: from streptomycin to the era of megatrials.

PubMed

Hilbrich, Lutz; Sleight, Peter

2006-09-01

Randomized clinical trials (RCTs) are the definitive contributors to evidence-based medicine. RCTs assessing serious outcomes in cardiovascular disease have grown, with 'megatrials' becoming more common with the realization that wrong conclusions resulted from random error in inadequately sized trials. Simple design and a heterogeneous patient population were early features, but multinational trials have increased in scientific, logistical, bureaucratic, regulatory, and legal complexity. These studies now exceed the financial means of academia or medical charities. Governments have left the bill with the pharmaceutical industry, encouraging a symbiosis with academics, who contribute medical and scientific expertise, and access to patients. Industry provides pharmacological, pharmaceutical, technical and regulatory know-how, good clinical practice expertise, and legal assistance during the trial. Study supervision is then in the hands of an independent steering committee and associated subcommittees, until appropriate dissemination of results. Prospectively defined interaction with the sponsor facilitates unbiased design and conduct, but arrangements need careful implementation to avoid conflicts of interest. The patient is protected by a strong data safety monitoring board that is wholly independent. Megatrials are under threat from over-regulation, increasing costs, and difficulties in execution. These issues merit urgent public and political education and debate.

A multinational clinical approach to assessing the effectiveness of catheter-based ultrasound renal denervation: The RADIANCE-HTN and REQUIRE clinical study designs.

PubMed

Mauri, Laura; Kario, Kazuomi; Basile, Jan; Daemen, Joost; Davies, Justin; Kirtane, Ajay J; Mahfoud, Felix; Schmieder, Roland E; Weber, Michael; Nanto, Shinsuke; Azizi, Michel

2018-01-01

Catheter-based renal denervation is a new approach to treat hypertension via modulation of the renal sympathetic nerves. Although nonrandomized and small, open-label randomized studies resulted in significant reductions in office blood pressure 6months after renal denervation with monopolar radiofrequency catheters, the first prospective, randomized, sham-controlled study (Symplicity HTN-3) failed to meet its blood pressure efficacy end point. New clinical trials with new catheters have since been designed to address the limitations of earlier studies. Accordingly, the RADIANCE-HTN and REQUIRE studies are multicenter, blinded, randomized, sham-controlled trials designed to assess the blood pressure-lowering efficacy of the ultrasound-based renal denervation system (Paradise) in patients with established hypertension either on or off antihypertensive medications, is designed to evaluate patients in 2 cohorts-SOLO and TRIO, in the United States and Europe. The SOLO cohort includes patients with essential hypertension, at low cardiovascular risk, and either controlled on 1 to 2 antihypertensive medications or uncontrolled on 0 to 2 antihypertensive medications. Patients undergo a 4-week medication washout period before randomization to renal denervation (treatment) or renal angiogram (sham). The TRIO cohort includes patients with hypertension resistant to at least 3 antihypertensive drugs including a diuretic. Patients will be stabilized on a single-pill, triple-antihypertensive-drug combination for 4weeks before randomization to treatment or sham. Reduction in daytime ambulatory systolic blood pressure (primary end point) will be assessed at 2months in both cohorts. A predefined medication escalation protocol, as needed for blood pressure control, is implemented between 2 and 6months in both cohorts by a study staff member blinded to the randomization process. At 6months, daytime ambulatory blood pressure and antihypertensive treatment score will be assessed. REQUIRE is designed to evaluate patients with resistant hypertension on standard of care medication in Japan and Korea. Reduction in 24-hour ambulatory systolic blood pressure will be assessed at 3months (primary end point). Both studies are enrolling patients, and their results are expected in 2018. Copyright © 2017 Elsevier Inc. All rights reserved.

Optimizing prevention of hospital-acquired venous thromboembolism (VTE): prospective validation of a VTE risk assessment model.

PubMed

Maynard, Gregory A; Morris, Timothy A; Jenkins, Ian H; Stone, Sarah; Lee, Joshua; Renvall, Marian; Fink, Ed; Schoenhaus, Robert

2010-01-01

Hospital-acquired (HA) venous thromboembolism (VTE) is a common source of morbidity/mortality. Prophylactic measures are underutilized. Available risk assessment models/protocols are not prospectively validated. Improve VTE prophylaxis, reduce HA VTE, and prospectively validate a VTE risk-assessment model. Observational design. Academic medical center. Adult inpatients on medical/surgical services. A simple VTE risk assessment linked to a menu of preferred VTE prophylaxis methods, embedded in order sets. Education, audit/feedback, and concurrent identification of nonadherence. Randomly sampled inpatient audits determined the percent of patients with "adequate" VTE prevention. HA VTE cases were identified concurrently via digital imaging system. Interobserver agreement for VTE risk level and judgment of adequate prophylaxis were calculated from 150 random audits. Interobserver agreement with 5 observers was high (kappa score for VTE risk level = 0.81, and for judgment of "adequate" prophylaxis = 0.90). The percent of patients on adequate prophylaxis improved each of the 3 years (58%, 78%, and 93%; P < 0.001) and reached 98% in the last 6 months of 2007; 361 cases of HA VTE occurred over 3 years. Significant reductions for the risk of HA VTE (risk ratio [RR] = 0.69; 95% confidence interval [CI] = 0.47-0.79) and preventable HA VTE (RR = 0.14; 95% CI = 0.06-0.31) occurred. We detected no increase in heparin-induced thrombocytopenia (HIT) or prophylaxis-related bleeding using administrative data/chart review. We prospectively validated a VTE risk-assessment/prevention protocol by demonstrating ease of use, good interobserver agreement, and effectiveness. Improved VTE prophylaxis resulted in a substantial reduction in HA VTE. (c) 2010 Society of Hospital Medicine.

PHARMacy-based interdisciplinary program for patients with Chronic Heart Failure (PHARM-CHF): rationale and design of a randomized controlled trial, and results of the pilot study.

PubMed

Laufs, Ulrich; Griese-Mammen, Nina; Krueger, Katrin; Wachter, Angelika; Anker, Stefan D; Koehler, Friedrich; Rettig-Ewen, Volker; Botermann, Lea; Strauch, Dorothea; Trenk, Dietmar; Böhm, Michael; Schulz, Martin

2018-05-30

We report the rationale and design of a community PHARMacy-based prospective randomized controlled interdisciplinary study for ambulatory patients with Chronic Heart Failure (PHARM-CHF) and results of its pilot study. The pilot study randomized 50 patients to a pharmacy-based intervention or usual care for 12 months. It demonstrated the feasibility of the design and showed reduced systolic blood pressure in the intervention group as indicator for improved medication adherence. The main study will randomize patients ≥60 years on stable pharmacotherapy including at least one diuretic and a history of heart failure hospitalization within 12 months. The intervention group will receive a medication review at baseline followed by regular dose dispensing of the medication, counselling regarding medication use and symptoms of heart failure. The control patients are unknown to the pharmacy and receive usual care. The primary efficacy endpoint is medication adherence, pre-specified as a significant difference of the proportion of days covered between the intervention and control group within 365 days following randomization using pharmacy claims data for three CHF medications (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, beta-blockers, and mineralocorticoid receptor antagonists). The primary composite safety endpoint is days lost due to blindly adjudicated unplanned cardiovascular hospitalizations or death. Overall, 248 patients shall be randomized. The minimum follow-up is 12 months with an expected mean of 24 months. Based on the feasibility demonstrated in the pilot study, the randomized PHARM-CHF trial will test whether an interdisciplinary pharmacy-based intervention can safely improve medication adherence and will estimate the potential impact on clinical endpoints. ClinicalTrials.gov Identifier: NCT01692119. © 2018 The Authors. European Journal of Heart Failure © 2018 European Society of Cardiology.

Prospective Randomized Trial of the Military Anti-Shock Garment

DTIC Science & Technology

1987-12-20

No prospective, controlled, randomized studies of !.’AST use were available in the scientific literature. Numerous --ports of MAST use were available...in the scientific literature. ,umerous reports of MAST causing compartment syndromes and amputations did appear in the literature. Beginning in 1983...research funding, computerization of these work sheets became possible, making analysis possible. In that no definitive or scientific clinically controlled

A Theoretically Based Behavioral Nutrition Intervention for Community Elders at High Risk: The B-NICE Randomized Controlled Clinical Trial

PubMed Central

LOCHER, JULIE L.; BALES, CONNIE W.; ELLIS, AMY C.; LAWRENCE, JEANNINE C.; NEWTON, LAURA; RITCHIE, CHRISTINE S.; ROTH, DAVID L.; BUYS, DAVID L.; VICKERS, KRISTIN S.

2012-01-01

We conducted a study designed to evaluate the efficacy and feasibility of a multilevel self-management intervention to improve nutritional intake in a group of older adults receiving Medicare home health services who were at especially high risk for experiencing undernutrition. The Behavioral Nutrition Intervention for Community Elders (B-NICE) trial used a prospective randomized controlled design to determine whether individually tailored counseling focused on social and behavioral aspects of eating resulted in increased caloric intake and improved nutrition-related health outcomes in a high-risk population of older adults. The study was guided by the theoretical approaches of the Ecological Model and Social Cognitive Theory. The development and implementation of the B-NICE protocol, including the theoretical framework, methodology, specific elements of the behavioral intervention, and assurances of the treatment fidelity, as well as the health policy implications of the trial results, are presented in this article. PMID:22098180

Relationship between the Mediterranean dietary pattern and musculoskeletal health in children, adolescents, and adults: systematic review and evidence map

PubMed Central

Craig, Jean V; Bunn, Diane K; Hayhoe, Richard P; Appleyard, Will O; Lenaghan, Elizabeth A; Welch, Ailsa A

2017-01-01

Context: An understanding of the modifiable effects of diet on bone and skeletal muscle mass and strength over the life course will help inform strategies to reduce age-related fracture risk. The Mediterranean diet is rich in nutrients that may be important for optimal musculoskeletal health. Objective: The aim of this systematic review was to investigate the relationship between a Mediterranean diet and musculoskeletal outcomes (fracture, bone density, osteoporosis, sarcopenia) in any age group. Data Sources: Ten electronic databases were searched. Study Selection: Randomized controlled trials and prospective cohort studies that investigated a traditional Mediterranean diet, published in any language, were eligible. Studies using other designs or other definitions of the Mediterranean diet were collated separately in an evidence map. Data Extraction: Details on study design, methods, population, dietary intervention or exposure, length of follow-up, and effect on or association with musculoskeletal outcomes were extracted. Results: The search yielded 1738 references. Data from eligible randomized controlled trials (n = 0) and prospective cohort studies (n = 3) were synthesized narratively by outcome for the systematic review. Two of these studies reported on hip fracture incidence, but results were contradictory. A third study found no association between the Mediterranean diet and sarcopenia incidence. Conclusions: Overall, the systematic review and evidence map demonstrate a lack of research to understand the relationship between the Mediterranean diet and musculoskeletal health in all ages. Systematic Review Registration: PROSPERO registration number IDCRD42016037038. PMID:29028268

Comparison of Radiofrequency Thermal Ablation and Microdebrider-Assisted Turbinoplasty in Inferior Turbinate Hypertrophy: A Prospective, Randomized, and Clinical Study

PubMed Central

Akagün, Fatih; İmamoğlu, Mehmet; Çobanoğlu, Hatice Bengü; Ural, Ahmet

2016-01-01

Objective To compare the effectiveness of radiofrequency thermal ablation with those of microdebrider-assisted turbinoplasty, we designed a prospective, randomized clinical study. Methods Forty patients suffering from nasal obstruction due to bilateral inferior turbinate hypertrophy were enrolled. Half of the patients were operated by radiofrequency thermal ablation, while the other half underwent microdebrider-assisted turbinoplasty. The outcomes of both techniques were compared in terms of symptomatology, nasal patency, and mucociliary transport. Results A statistically significant difference existed between the two groups with respect to nasal obstruction and the frequency of obstruction at the first post-operative week and first and third post-operative months (p<0.05). Rhinomanometry detected a significant decrease in nasal resistance values in both surgical groups compared to the preoperative values. The mucociliary transport time was significantly prolonged in the first postoperative week and first postoperative month in microdebrider-assisted inferior turbinoplasty group. Conclusion Both radiofrequency thermal ablation and microdebrider-assisted turbinoplasty are effective techniques for treating inferior turbinate hypertrophy. The treatment modality should be individually determined, and parameters such as tissue healing, volume reduction, and mucociliary activity must be taken into account. PMID:29392030

Factors Influencing Functional Outcomes and Return-to-Work After Amputation: A Review of the Literature.

PubMed

Darter, Benjamin J; Hawley, Carolyn E; Armstrong, Amy J; Avellone, Lauren; Wehman, Paul

2018-02-03

Purpose Amputation is a life changing event that can significantly impact an individual's physical and mental well-being. Our objective was to review literature exploring the impact of amputation upon a person's functioning and inclusion in the workplace. Methods Medline, CINAHL, and PsycINFO were searched using keywords related to amputation, employment and community reintegration. Eligible studies were published since 2000 and one of the following study designs: randomized controlled trial, non-randomized controlled trial, retrospective study, prospective study, concurrent cohort study, or cross sectional study. Studies for civilians with amputation as well as service members and Veterans with amputation were considered for inclusion. Results The search identified 995 articles, 25 of which met inclusion/exclusion criteria and were included in the review. While strong evidence for correlations and predictors of outcomes after amputation were limited, multiple factors were identified as contributing to physical functioning and employment after amputation. Conclusions Outcomes after amputation can vary widely with many potentially inter-related factors contributing. The factors identified may also serve to inform the development of interventions aiming to improve functional performance and reintegration after amputation. Furthermore, the review highlights the need for more high quality prospective studies.

Online self-administered training for post-traumatic stress disorder treatment providers: design and methods for a randomized, prospective intervention study

PubMed Central

2012-01-01

This paper presents the rationale and methods for a randomized controlled evaluation of web-based training in motivational interviewing, goal setting, and behavioral task assignment. Web-based training may be a practical and cost-effective way to address the need for large-scale mental health training in evidence-based practice; however, there is a dearth of well-controlled outcome studies of these approaches. For the current trial, 168 mental health providers treating post-traumatic stress disorder (PTSD) were assigned to web-based training plus supervision, web-based training, or training-as-usual (control). A novel standardized patient (SP) assessment was developed and implemented for objective measurement of changes in clinical skills, while on-line self-report measures were used for assessing changes in knowledge, perceived self-efficacy, and practice related to cognitive behavioral therapy (CBT) techniques. Eligible participants were all actively involved in mental health treatment of veterans with PTSD. Study methodology illustrates ways of developing training content, recruiting participants, and assessing knowledge, perceived self-efficacy, and competency-based outcomes, and demonstrates the feasibility of conducting prospective studies of training efficacy or effectiveness in large healthcare systems. PMID:22583520

Perspectives on the management of antiplatelet therapy in patients with coronary artery disease requiring cardiac and noncardiac surgery.

PubMed

Franchi, Francesco; Rollini, Fabiana; Angiolillo, Dominick J

2014-11-01

To provide an updated overview on the management of antiplatelet therapy in patients with coronary stents undergoing cardiac and noncardiac surgery. Surgical procedures are frequently performed in patients with coronary stents and are associated with an increased risk of ischemic and bleeding complications in the perioperative period. Given the lack of well-designed prospective randomized trials, guidelines recommendations are currently derived from observational studies and expert consensus. Defining the optimal balance between the risk of thrombotic events following discontinuation of antiplatelet therapy and the risk of hemorrhagic complications of having a surgical procedure while on antiplatelet therapy is pivotal. Elective surgery should be postponed for at least 4 weeks after bare metal stent implantation and 6-12 months after drug-eluting stent. If this is not possible, aspirin should be continued in the perioperative period, although the management of P2Y₁₂ inhibitors should be individualized according to the individual patient and type of surgery. In the absence of well-defined recommendations deriving from prospective randomized clinical trials, the perioperative management of antiplatelet therapy should be based on the balance between the specific thrombotic and hemorrhagic risks that characterize each patient and each surgical procedure.

Early morning urine collection to improve urinary lateral flow LAM assay sensitivity in hospitalised patients with HIV-TB co-infection.

PubMed

Gina, Phindile; Randall, Philippa J; Muchinga, Tapuwa E; Pooran, Anil; Meldau, Richard; Peter, Jonny G; Dheda, Keertan

2017-05-12

Urine LAM testing has been approved by the WHO for use in hospitalised patients with advanced immunosuppression. However, sensitivity remains suboptimal. We therefore examined the incremental diagnostic sensitivity of early morning urine (EMU) versus random urine sampling using the Determine® lateral flow lipoarabinomannan assay (LF-LAM) in HIV-TB co-infected patients. Consenting HIV-infected inpatients, screened as part of a larger prospective randomized controlled trial, that were treated for TB, and could donate matched random and EMU samples were included. Thus paired sample were collected from the same patient, LF-LAM was graded using the pre-January 2014, with grade 1 and 2 manufacturer-designated cut-points (the latter designated grade 1 after January 2014). Single sputum Xpert-MTB/RIF and/or TB culture positivity served as the reference standard (definite TB). Those treated for TB but not meeting this standard were designated probable TB. 123 HIV-infected patients commenced anti-TB treatment and provided matched random and EMU samples. 33% (41/123) and 67% (82/123) had definite and probable TB, respectively. Amongst those with definite TB LF-LAM sensitivity (95%CI), using the grade 2 cut-point, increased from 12% (5-24; 5/43) to 39% (26-54; 16/41) with random versus EMU, respectively (p = 0.005). Similarly, amongst probable TB, LF-LAM sensitivity increased from 10% (5-17; 8/83) to 24% (16-34; 20/82) (p = 0.001). LF-LAM specificity was not determined. This proof of concept study indicates that EMU could improve the sensitivity of LF-LAM in hospitalised TB-HIV co-infected patients. These data have implications for clinical practice.

Efficacy of Multivitamin/mineral Supplementation to Reduce Chronic Disease Risk: A Critical Review of the Evidence from Observational Studies and Randomized Controlled Trials.

PubMed

Angelo, Giana; Drake, Victoria J; Frei, Balz

2015-01-01

We reviewed recent scientific evidence regarding the effects of multivitamin/mineral (MVM) supplements on risk of chronic diseases, including cancer, cardiovascular disease, and age-related eye diseases. Data from randomized controlled trials (RCTs) and observational, prospective cohort studies were examined. The majority of scientific studies investigating the use of MVM supplements in chronic disease risk reduction reported no significant effect. However, the largest and longest RCT of MVM supplements conducted to date, the Physicians' Health Study II (PHS II), found a modest and significant reduction in total and epithelial cancer incidence in male physicians, consistent with the Supplémentation en Vitamines et Minéraux Antioxydants (SU.VI.MAX) trial. In addition, PHS II found a modest and significant reduction in the incidence of nuclear cataract, in agreement with several other RCTs and observational, prospective cohort studies. The effects of MVM use on other subtypes of cataract and age-related macular degeneration remain unclear. Neither RCTs nor prospective cohort studies are without their limitations. The placebo-controlled trial design of RCTs may be inadequate for nutrient interventions, and residual confounding, measurement error, and the possibility of reverse causality are inherent to any observational study. National surveys show that micronutrient inadequacies are widespread in the US and that dietary supplements, of which MVMs are the most common type, help fulfill micronutrient requirements in adults and children.

Immune tolerance: critical issues of factor dose, purity and treatment complications.

PubMed

DiMichele, D M

2006-12-01

The current practice of immune tolerance induction (ITI) therapy has been largely influenced by the results of small institutional studies and three large registries. However, many questions remain. Successful outcome predictors for ITI in haemophilia A have been suggested by the analyses of two of these registries. Among these predictors, factor VIII (FVIII) dose/dosing regimen remains a controversial outcome parameter, demonstrating a strong direct relationship to ITI success in the international registry and a weaker inverse relationship in the North American registry. There is an international multicentre prospective randomized trial underway to further study the role of FVIII dose in successful ITI induction in a good risk haemophilia A inhibitor patient cohort. FVIII purity also remains an unproved ITI outcome predictor. Institutional experience with von-Willebrand-factor-containing products has suggested its therapeutic advantage in both inhibitor development and eradication. The International ITI Study, although not designed to answer this particular question, may be able to determine an impact on outcome depending on the final distribution of investigator choice of product among the study subjects. Much less is known about the influence of factor IX (FIX) dose and purity on ITI success in haemophilia B. Importantly, nephrotic syndrome has been a major determinant of ITI failure in FIX inhibitor patients, particularly those with the allergic phenotype. Unfortunately, large prospective randomized trials in this group will not be feasible. Rather, we will have to rely on prospectively collected registry data to build our knowledge base of inhibitors and ITI in haemophilia B.

Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study: Rationale and design for a randomized controlled trial evaluating rheumatoid arthritis risk education to first-degree relatives

PubMed Central

Sparks, Jeffrey A.; Iversen, Maura D.; Kroouze, Rachel Miller; Mahmoud, Taysir G.; Triedman, Nellie A.; Kalia, Sarah S.; Atkinson, Michael L.; Lu, Bing; Deane, Kevin D.; Costenbader, Karen H.; Green, Robert C.; Karlson, Elizabeth W.

2014-01-01

We present the rationale, design features, and protocol of the Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study (ClinicalTrials.gov NCT02046005). The PRE-RA Family Study is an NIH-funded prospective, randomized controlled trial designed to compare the willingness to change behaviors in first-degree relatives of rheumatoid arthritis (RA) patients without RA after exposure to RA risk educational programs. Consented subjects are randomized to receive education concerning their personalized RA risk based on demographics, RA-associated behaviors, genetics and biomarkers or to receive standard RA information. Four behavioral factors associated with RA risk were identified from prior studies for inclusion in the risk estimate: cigarette smoking, excess body weight, poor oral health, and low fish intake. Personalized RA risk information is presented through an online tool that collects data on an individual's specific age, gender, family history, and risk-related behaviors; presents genetic and biomarker results; displays relative and absolute risk of RA; and provides personalized feedback and education. The trial outcomes will be changes in willingness to alter behaviors from baseline to 6 weeks, 6 months, and 12 months in the three intervention groups. The design and execution of this trial that targets a special population at risk for RA, while incorporating varied risk factors into a single risk tool, offer distinct challenges. We provide the theoretical rationale for the PRE-RA Family Study and highlight particular design features of this trial that utilize personalized risk education as an intervention. PMID:25151341

Efficacy and safety of sacubitril/valsartan (LCZ696) in Japanese patients with chronic heart failure and reduced ejection fraction: Rationale for and design of the randomized, double-blind PARALLEL-HF study.

PubMed

Tsutsui, Hiroyuki; Momomura, Shinichi; Saito, Yoshihiko; Ito, Hiroshi; Yamamoto, Kazuhiro; Ohishi, Tomomi; Okino, Naoko; Guo, Weinong

2017-09-01

The prognosis of heart failure patients with reduced ejection fraction (HFrEF) in Japan remains poor, although there is growing evidence for increasing use of evidence-based pharmacotherapies in Japanese real-world HF registries. Sacubitril/valsartan (LCZ696) is a first-in-class angiotensin receptor neprilysin inhibitor shown to reduce mortality and morbidity in the recently completed largest outcome trial in patients with HFrEF (PARADIGM-HF trial). The prospectively designed phase III PARALLEL-HF (Prospective comparison of ARNI with ACE inhibitor to determine the noveL beneficiaL trEatment vaLue in Japanese Heart Failure patients) study aims to assess the clinical efficacy and safety of LCZ696 in Japanese HFrEF patients, and show similar improvements in clinical outcomes as the PARADIGM-HF study enabling the registration of LCZ696 in Japan. This is a multicenter, randomized, double-blind, parallel-group, active controlled study of 220 Japanese HFrEF patients. Eligibility criteria include a diagnosis of chronic HF (New York Heart Association Class II-IV) and reduced ejection fraction (left ventricular ejection fraction ≤35%) and increased plasma concentrations of natriuretic peptides [N-terminal pro B-type natriuretic peptide (NT-proBNP) ≥600pg/mL, or NT-proBNP ≥400pg/mL for those who had a hospitalization for HF within the last 12 months] at the screening visit. The study consists of three phases: (i) screening, (ii) single-blind active LCZ696 run-in, and (iii) double-blind randomized treatment. Patients tolerating LCZ696 50mg bid during the treatment run-in are randomized (1:1) to receive LCZ696 100mg bid or enalapril 5mg bid for 4 weeks followed by up-titration to target doses of LCZ696 200mg bid or enalapril 10mg bid in a double-blind manner. The primary outcome is the composite of cardiovascular death or HF hospitalization and the study is an event-driven trial. The design of the PARALLEL-HF study is aligned with the PARADIGM-HF study and aims to assess the efficacy and safety of LCZ696 in Japanese HFrEF patients. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

The Medical and Endovascular Treatment of Atherosclerotic Renal Artery Stenosis (METRAS) study: rationale and study design.

PubMed

Rossi, G P; Seccia, T M; Miotto, D; Zucchetta, P; Cecchin, D; Calò, L; Puato, M; Motta, R; Caielli, P; Vincenzi, M; Ramondo, G; Taddei, S; Ferri, C; Letizia, C; Borghi, C; Morganti, A; Pessina, A C

2012-08-01

It is unclear whether revascularization of renal artery stenosis (RAS) by means of percutaneous renal angioplasty and stenting (PTRAS) is advantageous over optimal medical therapy. Hence, we designed a randomized clinical trial based on an optimized patient selection strategy and hard experimental endpoints. Primary objective of this study is to determine whether PTRAS is superior or equivalent to optimal medical treatment for preserving glomerular filtration rate (GFR) in the ischemic kidney as assessed by 99mTcDTPA sequential renal scintiscan. Secondary objectives of this study are to establish whether the two treatments are equivalent in lowering blood pressure, preserving overall renal function and regressing target organ damage, preventing cardiovascular events and improving quality of life. The study is designed as a prospective multicentre randomized, un-blinded two-arm study. Eligible patients will have clinical and angio-CT evidence of RAS. Inclusion criteria is RAS affecting the main renal artery or its major branches either >70% or, if <70, with post-stenotic dilatation. Renal function will be assessed with 99mTc-DTPA renal scintigraphy. Patients will be randomized to either arms considering both resistance index value in the ischemic kidney and the presence of unilateral/bilateral stenosis. Primary experimental endpoint will be the GFR of the ischemic kidney, assessed as quantitative variable by 99TcDTPA, and the loss of ischemic kidney defined as a categorical variable.

Testing prospectively the effectiveness and safety of paclitaxel-eluting stents in over 1000 very high-risk patients: design, baseline characteristics, procedural data and in-hospital outcomes of the multicenter Taxus in Real-life Usage Evaluation (TRUE) Study.

PubMed

Biondi-Zoccai, Giuseppe G L; Sangiorgi, Giuseppe M; Antoniucci, David; Grube, Eberhard; Di Mario, Carlo; Reimers, Bernard; Tamburino, Corrado; Agostoni, Pierfrancesco; Cosgrave, John; Colombo, Antonio

2007-05-02

Paclitaxel-eluting stents (PES) have been proved effective in randomized trials enrolling highly selected patients. Yet, given the uncertainty concerning results of PES implantation in very high-risk patients and lesions, we designed a prospective multicenter registry, the Taxus in Real-life Usage Evaluation (TRUE) Study. STUDY DESIGN, PATIENT CHARACTERISTICS AND IN-HOSPITAL OUTCOMES: Consecutive patients undergoing PES implantation were enrolled provided that the target lesion treated with PES was an unprotected left main (ULM), a true bifurcation, a chronic total occlusion (CTO), a long lesion (>28 mm), located in a small vessel (<2.75 mm), or the patient had diabetes mellitus. Clinical events will be adjudicated at 1, 7 and 12 months, with 4- to 8-month angiographic follow-up. The primary end-point will be the 7-month occurrence of major adverse cardiovascular events (MACE, i.e. the composite of cardiac death, non-fatal myocardial infarction [MI], coronary artery bypass grafting [CABG] and percutaneous target vessel revascularization [TVR]). To date, patient enrollment has been completed reaching the target of 1065 subjects. These included 322 (30.2%) diabetics, 115 (10.8%) subjects undergoing PES implantation for ULM, 229 (21.5%) in a bifurcation, 191 (17.9%) in a CTO, 430 (40.4%) in a small vessel, and 289 (27.1%) in a long lesion. An average of 1.5+/-0.6 vessels and 2.0+/-1.0 lesions were treated per patient, with 2.0+/-1.2 PES implanted per patient, and a 46+/-30 mm total PES length per patient. In-hospital MACE occurred in 39 (3.7%) patients, with 2 (0.2%) cardiac deaths, 32 (3.0%) MI, 5 (0.5%) TVR, no CABG, and 4 (0.4%) acute stent thromboses. Despite the availability of randomized trials, only carefully designed and prospective registries can provide timely and accurate assessment of the risk-benefit profile of PES in very high-risk patients. Indeed, the TRUE Study, including as much as 115 ULM and 229 bifurcation interventions, should give important insights into the outcome of PES in such an unprecedented and challenging context.

A Prospective Randomized Trial of Two Different Prostate Biopsy Schemes

ClinicalTrials.gov

2016-07-03

Prostate Cancer; Local Anesthesia; Prostate-Specific Antigen/Blood; Biopsy/Methods; Image-guided Biopsy/Methods; Prostatic Neoplasms/Diagnosis; Prostate/Pathology; Prospective Studies; Humans; Male; Ultrasonography, Interventional/Methods

Prospective registration trends, reasons for retrospective registration and mechanisms to increase prospective registration compliance: descriptive analysis and survey

PubMed Central

Seidler, Anna Lene; Askie, Lisa M

2018-01-01

Objectives To analyse prospective versus retrospective trial registration trends on the Australian New Zealand Clinical Trials Registry (ANZCTR) and to evaluate the reasons for non-compliance with prospective registration. Design Part 1: Descriptive analysis of trial registration trends from 2006 to 2015. Part 2: Online registrant survey. Participants Part 1: All interventional trials registered on ANZCTR from 2006 to 2015. Part 2: Random sample of those who had retrospectively registered a trial on ANZCTR between 2010 and 2015. Main outcome measures Part 1: Proportion of prospective versus retrospective clinical trial registrations (ie, registration before versus after enrolment of the first participant) on the ANZCTR overall and by various key metrics, such as sponsor, funder, recruitment country and sample size. Part 2: Reasons for non-compliance with prospective registration and perceived usefulness of various proposed mechanisms to improve prospective registration compliance. Results Part 1: Analysis of the complete dataset of 9450 trials revealed that compliance with prospective registration increased from 48% (216 out of 446 trials) in 2006 to 63% (723/1148) in 2012 and has since plateaued at around 64%. Patterns of compliance were relatively consistent across sponsor and funder types (industry vs non-industry), type of intervention (drug vs non-drug) and size of trial (n<100, 100–500, >500). However, primary sponsors from Australia/New Zealand were almost twice as likely to register prospectively (62%; 4613/7452) compared with sponsors from other countries with a WHO Network Registry (35%; 377/1084) or sponsors from countries without a WHO Registry (29%; 230/781). Part 2: The majority (56%; 84/149) of survey respondents cited lack of awareness as a reason for not registering their study prospectively. Seventy-four per cent (111/149) stated that linking registration to ethics approval would facilitate prospective registration. Conclusions Despite some progress, compliance with prospective registration remains suboptimal. Linking registration to ethics approval was the favoured strategy among those sampled for improving compliance. PMID:29496896

Prevention of EP Migratory Contamination in a Cluster Randomized Trial to Increase tPA Use in Stroke (The INSTINCT Trial)

PubMed Central

Weston, Victoria C.; Meurer, William J.; Frederiksen, Shirley M.; Fox, Allison K.; Scott, Phillip A.

2016-01-01

Objectives Cluster randomized trials (CRTs) are increasingly utilized to evaluate quality improvement interventions aimed at healthcare providers. In trials testing emergency department interventions, migration of emergency physicians (EPs) between hospitals is an important concern, as contamination may affect both internal and external validity. We hypothesized that geographically isolating emergency departments would prevent migratory contamination in a CRT designed to increase ED delivery of tPA in stroke (The INSTINCT Trial). Methods INSTINCT was a prospective, cluster randomized, controlled trial. 24 Michigan community hospitals were randomly selected in matched pairs for study. Contamination was defined at the cluster level, with substantial contamination defined a priori as >10% of EPs affected. Non-adherence, total crossover (contamination + non-adherence), migration distance and characteristics were determined. Results 307 emergency physicians were identified at all sites. Overall, 7 (2.3%) changed study sites. 1 moved between control sites, leaving 6 (2.0%) total crossovers. Of these, 2 (0.7%) moved from intervention to control (contamination) and 4 (1.3%) moved from control to intervention (non-adherence). Contamination was observed in 2 of 12 control sites, with 17% and 9% contamination of the total site EP workforce at follow-up, respectively. Average migration distance was 42 miles for all EPs moving in the study and 35 miles for EPs moving from intervention to control sites. Conclusion The mobile nature of emergency physicians should be considered in the design of quality improvement CRTs. Increased reporting of contamination in CRTs is encouraged to clarify thresholds and facilitate CRT design. PMID:25440230

Case–control and prospective studies of dietary α-linolenic acid intake and prostate cancer risk: a meta-analysis

PubMed Central

Carleton, Amanda J; Sievenpiper, John L; de Souza, Russell; McKeown-Eyssen, Gail; Jenkins, David J A

2013-01-01

Objective α-Linolenic acid (ALA) is considered to be a cardioprotective nutrient; however, some epidemiological studies have suggested that dietary ALA intake increases the risk of prostate cancer. The main objective was to conduct a systematic review and meta-analysis of case–control and prospective studies investigating the association between dietary ALA intake and prostate cancer risk. Design A systematic review and meta-analysis were conducted by searching MEDLINE and EMBASE for relevant prospective and case–control studies. Included studies We included all prospective cohort, case–control, nested case-cohort and nested case–control studies that investigated the effect of dietary ALA intake on the incidence (or diagnosis) of prostate cancer and provided relative risk (RR), HR or OR estimates. Primary outcome measure Data were pooled using the generic inverse variance method with a random effects model from studies that compared the highest ALA quantile with the lowest ALA quantile. Risk estimates were expressed as RR with 95% CIs. Heterogeneity was assessed by χ2 and quantified by I2. Results Data from five prospective and seven case–control studies were pooled. The overall RR estimate showed ALA intake to be positively but non-significantly associated with prostate cancer risk (1.08 (0.90 to 1.29), p=0.40; I2=85%), but the interpretation was complicated by evidence of heterogeneity not explained by study design. A weak, non-significant protective effect of ALA intake on prostate cancer risk in the prospective studies became significant (0.91 (0.83 to 0.99), p=0.02) without evidence of heterogeneity (I2=8%, p=0.35) on removal of one study during sensitivity analyses. Conclusions This analysis failed to confirm an association between dietary ALA intake and prostate cancer risk. Larger and longer observational and interventional studies are needed to define the role of ALA and prostate cancer. PMID:23674441

China Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS): A new, prospective, multicenter, randomized controlled trial in China

PubMed Central

Gao, Peng; Zhao, Zhenwei; Wang, Daming; Wu, Jian; Cai, Yiling; Li, Tianxiao; Wu, Wei; Shi, Huaizhang; He, Weiwen; Zhu, Fengshui; Ling, Feng

2015-01-01

Background Patients with symptomatic stenosis of intradural arteries are at high risk for subsequent stroke. Since the SAMMPRIS trial, stenting is no longer recommended as primary treatment; however, the results of this trial, its inclusion criteria and its center selection received significant criticism and did not appear to reflect our experience regarding natural history nor treatment complications rate. As intracranial atherosclerosis (ICAS) is the most common cause for stroke in Asian countries, we are hereby proposing a refined prospective, randomized, multicenter study in an Asian population with strictly defined patient and participating center inclusion criteria. Methods The China Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS) trial is an ongoing, government-funded, prospective, multicenter, randomized trial. It recruits patients with recent TIA or stroke caused by 70%–99% stenosis of a major intracranial artery. Patients with previous stroke related to perforator ischemia will not be included. Only high-volume centers with a proven track record will enroll patients as determined by a lead-in phase. Patients will be randomized (1:1) to best medical therapy alone or medical therapy plus stenting. Primary endpoints are any stroke or death within 30 days after enrollment or after any revascularization procedure of the qualifying lesion during follow-up, or stroke in the territory of the symptomatic intracranial artery beyond 30 days. The CASSISS trial will be conducted in eight sites in China with core imaging lab review at a North American site and aims to have a sample size of 380 participants (stenting, 190; medical therapy, 190). Recruitment is expected to be finished by December 2016. Patients will be followed for at least three years. The trial is scheduled to complete in 2019. Conclusion In the proposed trial, certain shortcomings of SAMMPRIS including patient and participating center selection will be addressed. The present manuscript outlines the rationale and design of the study. We estimate that this trial will allow for a critical reappraisal of the role of intracranial stenting for selected patients in high-volume centers. PMID:25934656

Comparison of the effects of sodium hyaluronate-chondroitin sulphate and corticosteroid in the treatment of lateral epicondylitis: a prospective randomized trial.

PubMed

Tosun, Haci Bayram; Gumustas, Seyitali; Agir, Ismail; Uludag, Abuzer; Serbest, Sancar; Pepele, Demet; Ertem, Kadir

2015-09-01

Hyaluronic acid and glycosaminoglycans have shown positive effects in improving lateral epicondylitis and other tendinosis conditions. Therefore, we designed a prospective, randomized study to compare the effects of a combined sodium hyaluronate and chondroitin sulfate (HA + CS) injection versus a triamcinolone injection in the treatment of lateral epicondylitis. In total, 57 consecutive patients with clinically diagnosed lateral epicondylitis were divided randomly into two groups. In the HA + CS group, 25 patients received a single injection of a solution containing an HA + CS combination and prilocaine HCl, while the 32 patients in the triamcinolone group received a single injection of a solution of triamcinolone and prilocaine HCl. We evaluated the pain and function outcome measures using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire at the beginning of the study, and 3 and 6 months after the injection. Additionally, the Minimum Clinically Important Difference values and percentage changes in the PRTEE subscale scores between the assessments were calculated. No serious adverse events were reported throughout the study. The mean pain and function scores for the HA + CS and triamcinolone groups had significantly improved at 3 months, but the mean function scores in the HA + CS group were statistically significantly better when compared to the triamcinolone group. At 6 months, both groups had significantly improved mean pain and function scores, compared to the baseline scores; however, the mean pain and function scores in the 6-month HA + CS treatment group were better than in the 6-month triamcinolone group. The relative change for the mean total score in the HA + CS group was much better when compared with the triamcinolone group, and the HA + CS treatment group showed clinically significant improvement when compared with triamcinolone group at 3 and 6 months. This study supports the idea that for a single injection treatment of patients with lateral epicondylitis, a combination injection of HA + CS may offer better pain benefits for 6 months after injection, when compared to triamcinolone. Level II, Randomized Clinical Trial, Prospective Comparative Study.

Outcomes assessment in men undergoing open retropubic radical prostatectomy, laparoscopic radical prostatectomy, and robotic-assisted radical prostatectomy.

PubMed

Kowalczyk, Keith J; Yu, Hua-Yin; Ulmer, William; Williams, Stephen B; Hu, Jim C

2012-02-01

To review the various methods of outcomes assessment used for effectiveness studies comparing retropubic radical prostatectomy (RRP), laparoscopic radical prostatectomy (LRP), and robotic-assisted laparoscopic prostatectomy (RALP). A review of the peer reviewed literature was performed for reported series of RRP, LRP, and RALP using Pubmed and MEDLINE with emphasis on comparing perioperative, functional, and oncologic outcomes. Common methods used for outcomes assessment were categorized and compared, highlighting the pros and cons of each approach. The majority of the literature comparing RRP, LRP, and RALP comes in the form of observational data or administrative data from secondary datasets. While randomized controlled trials are ideal for outcomes assessment, only one such study was identified and was limited. Non-randomized observational studies contribute to the majority of data, however are limited due to retrospective study design, lack of consistent endpoints, and limited application to the general community. Administrative data provide accurate assessment of operative outcomes in both academic and community settings, however has limited ability to convey accurate functional outcomes. Non-randomized observational studies and secondary data are useful resources for assessment of outcomes; however, limitations exist for both. Neither is without flaws, and conclusions drawn from either should be viewed with caution. Until standardized prospective comparative analyses of RRP, LRP, and RALP are established, comparative outcomes data will remain imperfect. Urologic researchers must strive to provide the best available outcomes data through accurate prospective data collection and consistent outcomes reporting.

Protection of xenon against postoperative oxygen impairment in adults undergoing Stanford Type-A acute aortic dissection surgery: Study protocol for a prospective, randomized controlled clinical trial.

PubMed

Jin, Mu; Cheng, Yi; Yang, Yanwei; Pan, Xudong; Lu, Jiakai; Cheng, Weiping

2017-08-01

The available evidence shows that hypoxemia after Stanford Type-A acute aortic dissection (AAD) surgery is a frequent cause of several adverse consequences. The pathogenesis of postoperative hypoxemia after AAD surgery is complex, and ischemia/reperfusion and inflammation are likely to be underlying risk factors. Xenon, recognized as an ideal anesthetic and anti-inflammatory treatment, might be a possible treatment for these adverse effects. The trial is a prospective, double-blind, 4-group, parallel, randomized controlled, a signal-center clinical trial. We will recruit 160 adult patients undergoing Stanford type-A AAD surgery. Patients will be allocated a study number and will be randomized on a 1:1:1:1 basis to receive 1 of the 3 treatment options (pulmonary inflated with 50% xenon, 75% xenon, or 100% xenon) or no treatment (control group, pulmonary inflated with 50% nitrogen). The aims of this study are to clarify the lung protection capability of xenon and its possible mechanisms in patients undergoing the Stanford type-A AAD surgery. This trial uses an innovative design to account for the xenon effects of postoperative oxygen impairment, and it also delineates the mechanism for any benefit from xenon. The investigational xenon group is considered a treatment intervention, as it includes 3 groups of pulmonary static inflation with 50%, 75%, and 100% xenon. It is suggested that future trials might define an appropriate concentration of xenon for the best practice intervention.

A prospective, randomized evaluation of a novel everolimus-eluting coronary stent: the PLATINUM (a Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System [PROMUS Element] for the Treatment of Up to Two de Novo Coronary Artery Lesions) trial.

PubMed

Stone, Gregg W; Teirstein, Paul S; Meredith, Ian T; Farah, Bruno; Dubois, Christophe L; Feldman, Robert L; Dens, Joseph; Hagiwara, Nobuhisa; Allocco, Dominic J; Dawkins, Keith D

2011-04-19

We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI). Randomized trials have demonstrated an excellent safety and efficacy profile for the CoCr-EES. The PtCr-EES uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. A total of 1,530 patients undergoing PCI of 1 or 2 de novo native lesions were randomized at 132 worldwide sites to CoCr-EES (n = 762) or PtCr-EES (n = 768). The primary endpoint was the 12-month rate of target lesion failure (TLF), the composite of target vessel-related cardiac death, target vessel-related myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR) in the per-protocol population (patients who received ≥1 assigned study stent), powered for noninferiority. The 12-month rate of TLF in the per-protocol population occurred in 2.9% versus 3.4% of patients assigned to CoCr-EES versus PtCr-EES, respectively (difference: 0.5%, 95% confidence interval: -1.3% to 2.3%, p(noninferiority) = 0.001, p(superiority) = 0.60). By intention-to-treat, there were no significant differences between CoCr-EES and PtCr-EES in the 12-month rates of TLF (3.2% vs. 3.5%, p = 0.72), cardiac death or MI (2.5% vs. 2.0%, p = 0.56), TLR (1.9% vs. 1.9%, p = 0.96), or Academic Research Consortium definite or probable stent thrombosis (0.4% vs. 0.4%, p = 1.00). In this large-scale, prospective, single-blind randomized trial, a novel PtCr-EES was noninferior to the predicate CoCr-EES for TLF, with nonsignificant differences in measures of safety and efficacy through 12-month follow-up after PCI. Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Red and processed meat intake and risk of breast cancer: a meta-analysis of prospective studies.

PubMed

Guo, Jingyu; Wei, Wei; Zhan, Lixing

2015-05-01

Epidemiological studies regarding the association between red and processed meat intake and the risk of breast cancer have yielded inconsistent results. Therefore, we conducted an updated and comprehensive meta-analysis which included 14 prospective studies to evaluate the association of red and processed meat intake with breast cancer risk. Relevant prospective cohort studies were identified by searching PubMed through October 31, 2014, and by reviewing the reference lists of retrieved articles. Study-specific relative risk (RR) estimates were pooled using a random-effects model. Fourteen prospective studies on red meat (involving 31,552 cases) and 12 prospective studies on processed meat were included in the meta-analysis. The summary RRs (95 % CI) of breast cancer for the highest versus the lowest categories were 1.10 (1.02, 1.19) for red meat, and 1.08 (1.01, 1.15) for processed meat. The estimated summary RRs (95 % CI) were 1.11 (1.05, 1.16) for an increase of 120 g/day of red meat, and 1.09 (1.03, 1.16) for an increase of 50 g/day of processed meat. Our findings indicate that increased intake of red and processed meat is associated with an increased risk of breast cancer. Further research with well-designed cohort or interventional studies is needed to confirm the association.

EARLYDRAIN- outcome after early lumbar CSF-drainage in aneurysmal subarachnoid hemorrhage: study protocol for a randomized controlled trial.

PubMed

Bardutzky, Jürgen; Witsch, Jens; Jüttler, Eric; Schwab, Stefan; Vajkoczy, Peter; Wolf, Stefan

2011-09-14

Aneurysmal subarachnoid hemorrhage (SAH) may be complicated by delayed cerebral ischemia, which is a major cause of unfavorable clinical outcome and death in SAH-patients. Delayed cerebral ischemia is presumably related to the development of vasospasm triggered by the presence of blood in the basal cisterns. To date, oral application of the calcium antagonist nimodipine is the only prophylactic treatment for vasospasm recognized under international guidelines.In retrospective trials lumbar drainage of cerebrospinal fluid has been shown to be a safe and feasible measure to remove the blood from the basal cisterns and decrease the incidence of delayed cerebral ischemia and vasospasm in the respective study populations. However, the efficacy of lumbar drainage has not been evaluated prospectively in a randomized controlled trial yet. This is a protocol for a 2-arm randomized controlled trial to compare an intervention group receiving early continuous lumbar CSF-drainage and standard neurointensive care to a control group receiving standard neurointensive care only. Adults suffering from a first aneurysmal subarachnoid hemorrhage whose aneurysm has been secured by means of coiling or clipping are eligible for trial participation. The effect of early CSF drainage (starting < 72 h after securing the aneurysm) will be measured in the following ways: the primary endpoint will be disability after 6 months, assessed by a blinded investigator during a personal visit or standardized telephone interview using the modified Rankin Scale. Secondary endpoints include mortality after 6 months, angiographic vasospasm, transcranial Doppler sonography (TCD) mean flow velocity in both middle cerebral arteries and rate of shunt insertion at 6 months after hospital discharge. Here, we present the study design of a multicenter prospective randomized controlled trial to investigate whether early application of a lumbar drainage improves clinical outcome after aneurysmal subarachnoid hemorrhage.

Milrinone therapy for enterovirus 71-induced pulmonary edema and/or neurogenic shock in children: a randomized controlled trial.

PubMed

Chi, Chia-Yu; Khanh, Truong Huu; Thoa, Le Phan Kim; Tseng, Fan-Chen; Wang, Shih-Min; Thinh, Le Quoc; Lin, Chia-Chun; Wu, Han-Chieh; Wang, Jen-Ren; Hung, Nguyen Thanh; Thuong, Tang Chi; Chang, Chung-Ming; Su, Ih-Jen; Liu, Ching-Chuan

2013-07-01

Enterovirus 71-induced brainstem encephalitis with pulmonary edema and/or neurogenic shock (stage 3B) is associated with rapid mortality in children. In a small pilot study, we found that milrinone reduced early mortality compared with historical controls. This prospective, randomized control trial was designed to provide more definitive evidence of the ability of milrinone to reduce the 1-week mortality of stage 3B enterovirus 71 infections. Prospective, unicenter, open-label, randomized, controlled study. Inpatient ward of a large tertiary teaching hospital in Ho Chi Minh City, Vietnam. Children (≤ 18 yr old) admitted with proven enterovirus 71-induced pulmonary edema and/or neurogenic shock. Patients were randomly assigned to receive intravenous milrinone (0.5 μg/kg/min) (n = 22) or conventional management (n = 19). Both groups received dopamine or dobutamine and intravenous immunoglobulin. The primary endpoint was 1-week mortality. The secondary endpoints included length of ventilator dependence and hospital stay and adverse events. The median age was 2 years with a predominance of boys in both groups. The 1-week mortality was significantly lower, 18.2% (4/22) in the milrinone compared with 57.9% (11/19) in the conventional management group (relative risk = 0.314 [95% CI, 0.12-0.83], p = 0.01). The median duration of ventilator-free days was longer in the milrinone treatment group (p = 0.01). There was no apparent neurologic sequela in the survivors in either group, and no drug-related adverse events were documented. Milrinone significantly reduced the 1-week mortality of enterovirus 71-induced pulmonary edema and/or neurogenic shock without adverse effects. Further studies are needed to determine whether milrinone might be useful to prevent progression of earlier stages of brainstem encephalitis.

A Study on Chocolate Consumption in Prospective Teachers

ERIC Educational Resources Information Center

Ozgen, Leyla

2016-01-01

This study was planned and conducted to determine the chocolate consumption habits of prospective teachers. The study population was comprised of students attending the Faculty of Education at Gazi University in Ankara and the sample consisted of 251 prospective teachers selected with simple random sampling. 96.4% and 3.6% of the prospective…

The Relationship between Prospective Teachers' Critical Thinking Dispositions and Their Educational Philosophies

ERIC Educational Resources Information Center

Aybek, Birsel; Aslan, Serkan

2017-01-01

The aim of this research is to investigate the relationship between prospective teachers' critical thinking dispositions and their educational philosophies. The research used relational screening model. The study hosts a total of 429 prospective teachers selected by the simple random sampling method. Research data has been collected through…

The Effect of Botulinum Toxin A Injections in the Spine Muscles for Cerebral Palsy Scoliosis, Examined in a Prospective, Randomized Triple-blinded Study.

PubMed

Wong, Christian; Pedersen, Søren Anker; Kristensen, Billy B; Gosvig, Kasper; Sonne-Holm, Stig

2015-12-01

A prospective, randomized triple-blinded cross-over design treating with either botulinum toxin A (BXT) or saline (NaCl). To examine the efficacy of BTX treatment in cerebral palsy scoliosis (CPS). Intramuscular injections with BTX have been used off label in treating CPS. 1 prospective study has been conducted, demonstrating in both radiological and clinical improvement, whereas showing no side effects or complications. Subjects (brace-treated CPS between 2 and 18 yr) were injected using ultrasonic-guidance with either NaCl or BTX in selected spine muscles with 6 mo intervals (block randomization, sealed envelope). Radiographs of the spine and clinical follow-up were captured before and 6 weeks after each injection. Primary outcome parameter was radiological change in Cobb angle, where a 7° change was regarded as an effect (1 SD). Radiological parameters were measured before and 6 weeks after treatment by 3 experienced doctors separately. Moreover, clinical results were evaluated by the pediatric quality of life score and systematic open questioning of the parents about the child's wellbeing. Subjects, researchers, and monitors were blinded during the trial. Appropriate permissions (2008-004584-19) and no funding were obtained. 16 cerebral palsy patients (GFMCS III-V) with CPS were consecutively included, whereas 6 patients were excluded. There were no drop-outs to follow-up, but 1 possible serious adverse event of pneumonia resulting in death was recorded and the study was terminated. No significant radiological or clinical changes were detected when compared with NaCl injections using Wilcoxon matched pair signed-rank test. No positive radiological or clinical effects were demonstrated by this treatment, except for the parent's initial subjective but positive appraisal of the effect. However, the study was terminated due to 1 possible severe adverse event and scheduled numbers needed to treat (hence power) were not reached. 1.

The role of calcium in the prevention of cardiovascular disease--a review of observational studies and randomized clinical trials.

PubMed

Rautiainen, Susanne; Wang, Lu; Manson, JoAnn E; Sesso, Howard D

2013-11-01

Calcium is a mineral that is important for bone health and has also been suggested to play a role in the prevention of cardiovascular disease (CVD). Lately, the potential effects of both inadequate and excessive calcium intake have received growing attention. In this review, we summarize the evidence from experimental, epidemiologic, and clinical studies investigating the role of calcium intake, either from the diet or from supplements, as well as blood concentrations, in relation to the risk of CVD in adults. In vitro and in vivo laboratory studies suggest that calcium may be involved in CVD development through multiple pathways, including blood cholesterol, insulin secretion and sensitivity, vasodilation, inflammatory profile, thrombosis, obesity, and vascular calcification. Several prospective epidemiologic studies have examined how dietary or supplemental calcium intake is associated with CVD incidence or mortality in middle-aged and older adults, and the results are inconsistent. Prospective studies investigating blood concentrations of calcium have also reported mixed results. However, changes in blood calcium concentrations may reflect a disturbed calcium phosphate balance, which is associated with increased risk of CVD. To date there is no randomized clinical trial that has been designed specifically to test the effect of calcium supplementation on the risk of CVD as the primary end point. Existing trials have performed secondary analyses, and most of them have been conducted among postmenopausal women. These trials suggest that calcium supplementation has no effect on CVD development; however, they do not allow a definitive conclusion to be drawn. The average daily intake of calcium is low in many populations; however, the evidence for a potential role of dietary or supplemental calcium in the prevention of CVD remains insufficient and inconclusive. Only large-scale randomized trials designed to investigate the effects of calcium supplementation on CVD events as the primary end point, as well as short-term trials investigating the effect on coronary biomarkers, can provide a definitive answer.

Rationale and design of the Clinical Evaluation of Magnetic Resonance Imaging in Coronary heart disease 2 trial (CE-MARC 2): A prospective, multicenter, randomized trial of diagnostic strategies in suspected coronary heart disease

PubMed Central

Ripley, David P.; Brown, Julia M.; Everett, Colin C.; Bijsterveld, Petra; Walker, Simon; Sculpher, Mark; McCann, Gerry P.; Berry, Colin; Plein, Sven; Greenwood, John P.

2015-01-01

Background A number of investigative strategies exist for the diagnosis of coronary heart disease (CHD). Despite the widespread availability of noninvasive imaging, invasive angiography is commonly used early in the diagnostic pathway. Consequently, approximately 60% of angiograms reveal no evidence of obstructive coronary disease. Reducing unnecessary angiography has potential financial savings and avoids exposing the patient to unnecessary risk. There are no large-scale comparative effectiveness trials of the different diagnostic strategies recommended in international guidelines and none that have evaluated the safety and efficacy of cardiovascular magnetic resonance. Trial Design CE-MARC 2 is a prospective, multicenter, 3-arm parallel group, randomized controlled trial of patients with suspected CHD (pretest likelihood 10%-90%) requiring further investigation. A total of 1,200 patients will be randomized on a 2:2:1 basis to receive 3.0-T cardiovascular magnetic resonance–guided care, single-photon emission computed tomography–guided care (according to American College of Cardiology/American Heart Association appropriate-use criteria), or National Institute for Health and Care Excellence guidelines–based management. The primary (efficacy) end point is the occurrence of unnecessary angiography as defined by a normal (>0.8) invasive fractional flow reserve. Safety of each strategy will be assessed by 3-year major adverse cardiovascular event rates. Cost-effectiveness and health-related quality-of-life measures will be performed. Conclusions The CE-MARC 2 trial will provide comparative efficacy and safety evidence for 3 different strategies of investigating patients with suspected CHD, with the intension of reducing unnecessary invasive angiography rates. Evaluation of these management strategies has the potential to improve patient care, health-related quality of life, and the cost-effectiveness of CHD investigation. PMID:25497243

Heating and humidifying of carbon dioxide during pneumoperitoneum is not indicated: a prospective randomized trial.

PubMed

Davis, S S; Mikami, D J; Newlin, M; Needleman, B J; Barrett, M S; Fries, R; Larson, T; Dundon, J; Goldblatt, M I; Melvin, W S

2006-01-01

Carbon dioxide (CO2) pneumoperitoneum usually is created by a compressed gas source. This exposes the patient to cool dry gas delivered at room temperature (21 degrees C) with 0% relative humidity. Various delivery methods are available for humidifying and heating CO2 gas. This study was designed to determine the effects of heating and humidifying gas for the intraabdominal environment. For this study, 44 patients undergoing laparoscopic Roux-en-Y gastric bypass were randomly assigned to one of four arms in a prospective, randomized, single-blinded fashion: raw CO2 (group 1), heated CO2 (group 2), humidified CO2 (group 3), and heated and humidified CO2 (group 4). A commercially available CO2 heater-humidifier was used. Core temperatures, intraabdominal humidity, perioperative data, and postoperative outcomes were monitored. Peritoneal biopsies were taken in each group at the beginning and end of the case. Biopsies were subjected staining protocols designed to identify structural damage and macrophage activity. Postoperative narcotic use, pain scale scores, recovery room time, and length of hospital stay were recorded. One-way analysis of variance (ANOVA) and the nonparametric Kruskal-Wallis test were used to compare the groups. Demographics, volume of CO2 used, intraabdominal humidity, bladder temperatures, lens fogging, and operative times were not significantly different between the groups. Core temperatures were stable, and intraabdominal humidity measurements approached 100% for all the patients over the entire procedure. Total narcotic dosage and pain scale scores were not statistically different. Recovery room times and length of hospital stay were similar in all the groups. Only one biopsy in the heated-humidified group showed an increase in macrophage activity. The intraabdominal environment in terms of temperature and humidity was similar in all the groups. There was no significant difference in the intraoperative body temperatures or the postoperative variable measured. No histologic changes were identified. Heating or humidifying of CO2 is not justified for patients undergoing laparoscopic bariatric surgery.

Clinical studies in restorative dentistry: New directions and new demands.

PubMed

Opdam, N J M; Collares, K; Hickel, R; Bayne, S C; Loomans, B A; Cenci, M S; Lynch, C D; Correa, M B; Demarco, F; Schwendicke, F; Wilson, N H F

2018-01-01

Clinical research of restorative materials is confounded by problems of study designs, length of trials, type of information collected, and costs for trials, despite increasing numbers and considerable development of trials during the past 50 years. This opinion paper aims to discuss advantages and disadvantages of different study designs and outcomes for evaluating survival of dental restorations and to make recommendations for future study designs. Advantages and disadvantages of randomized trials, prospective and retrospective longitudinal studies, practice-based, pragmatic and cohort studies are addressed and discussed. The recommendations of the paper are that clinical trials should have rational control groups, include confounders such as patient risk factors in the data and analysis and should use outcome parameters relevant for profession and patients. Copyright © 2017 The Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

A Systematic Review on Immediate Loading of Implants Used to Support Overdentures Opposed by Conventional Prostheses: Factors That Might Influence Clinical Outcomes.

PubMed

Zygogiannis, Kostas; Wismeijer, Daniel; Aartman, Irene Ha; Osman, Reham B

2016-01-01

Different treatment protocols in terms of number, diameter, and suprastructure design have been proposed for immediately loaded implants that are used to support mandibular overdentures opposed by maxillary conventional dentures. The aim of this study was to investigate the influence of these protocols on survival rates as well as clinical and prosthodontic outcomes. Several electronic databases were searched for all relevant articles published from 1966 to June 2014. Only randomized controlled trials and prospective studies with a minimum follow-up of 12 months were selected. The primary outcomes of interest were the success and survival rates of the implants. Prosthodontic complications were also evaluated. Fourteen studies fulfilled the inclusion criteria. Of the studies identified, nine were randomized controlled trials and five were prospective studies. The mean follow-up period was 3 years or less for the vast majority of the studies. The reported survival and success rates were comparable to that of conventional loading for most of the included studies. No specific immediate loading protocol seemed to perform better in terms of clinical and prosthodontic outcomes. Immediate loading protocols of mandibular overdentures seem to be a viable alternative to conventional loading. It was not possible to recommend a specific treatment protocol related to the number, diameter of the implants, and attachment system used. Long-term, well-designed studies comparing different immediate loading modalities could help to establish a protocol that delivers the most clinically predictable, efficient, and cost-effective outcome for edentulous patients in need of implant overdentures.

Respiratory Outcomes of the Surfactant Positive Pressure and Oximetry Randomized Trial

PubMed Central

Stevens, Timothy P.; Finer, Neil N.; Carlo, Waldemar A.; Szilagyi, Peter G.; Phelps, Dale L.; Walsh, Michele C.; Gantz, Marie G.; Laptook, Abbot R.; Yoder, Bradley A.; Faix, Roger G.; Newman, Jamie E.; Das, Abhik; Do, Barbara T.; Schibler, Kurt; Rich, Wade; Newman, Nancy S.; Ehrenkranz, Richard A.; Peralta-Carcelen, Myriam; Vohr, Betty R.; Wilson-Costello, Deanne E.; Yolton, Kimberly; Heyne, Roy J.; Evans, Patricia W.; Vaucher, Yvonne E.; Adams-Chapman, Ira; McGowan, Elisabeth C.; Bodnar, Anna; Pappas, Athina; Hintz, Susan R.; Acarregui, Michael J.; Fuller, Janell; Goldstein, Ricki F.; Bauer, Charles R.; O’Shea, T. Michael; Myers, Gary J.; Higgins, Rosemary D.

2014-01-01

Objective To explore the early childhood pulmonary outcomes of infants who participated in the NICHD SUPPORT Trial, using a factorial design that randomized extremely preterm infants to lower vs. higher oxygen saturation targets and delivery room CPAP vs. intubation/surfactant, found no significant difference in the primary composite outcome of death or BPD. Study design The Breathing Outcomes Study, a prospective secondary to SUPPORT, assessed respiratory morbidity at 6 month intervals from hospital discharge to 18–22 months corrected age (CA). Two pre-specified primary outcomes, wheezing more than twice per week during the worst 2 week period and cough longer than 3 days without a cold were compared between each randomized intervention. Results One or more interviews were completed for 918 of 922 eligible infants. The incidence of wheezing and cough were 47.9% and 31.0%, respectively, and did not differ between study arms of either randomized intervention. Infants randomized to lower vs. higher oxygen saturation targets had similar risks of death or respiratory morbidities (except for croup, treatment with oxygen or diuretics at home). Infants randomized to CPAP vs. intubation/surfactant had fewer episodes of wheezing without a cold (28.9% vs. 36.5%, p<0.05), respiratory illnesses diagnosed by a doctor (47.7% vs. 55.2%, p<0.05) and physician or emergency room visits for breathing problems (68.0% vs. 72.9%, p<0.05) by 18–22 months CA. Conclusion Treatment with early CPAP rather than intubation/surfactant is associated with less respiratory morbidity by 18–22 months CA. Longitudinal assessment of pulmonary morbidity is necessary to fully evaluate the potential benefits of respiratory interventions for neonates. PMID:24725582

Community-based participatory research to design a faith-enhanced diabetes prevention program: The Better Me Within randomized trial.

PubMed

Kitzman, Heather; Dodgen, Leilani; Mamun, Abdullah; Slater, J Lee; King, George; Slater, Donna; King, Alene; Mandapati, Surendra; DeHaven, Mark

2017-11-01

Reducing obesity positively impacts diabetes and cardiovascular risk; however, evidence-based lifestyle programs, such as the diabetes prevention program (DPP), show reduced effectiveness in African American (AA) women. In addition to an attenuated response to lifestyle programs, AA women also demonstrate high rates of obesity, diabetes, and cardiovascular disease. To address these disparities, enhancements to evidence-based lifestyle programs for AA women need to be developed and evaluated with culturally relevant and rigorous study designs. This study describes a community-based participatory research (CBPR) approach to design a novel faith-enhancement to the DPP for AA women. A long-standing CBPR partnership designed the faith-enhancement from focus group data (N=64 AA adults) integrating five components: a brief pastor led sermon, memory verse, in class or take-home faith activity, promises to remember, and scripture and prayer integrated into participant curriculum and facilitator materials. The faith components were specifically linked to weekly DPP learning objectives to strategically emphasize behavioral skills with religious principles. Using a CBPR approach, the Better Me Within trial was able to enroll 12 churches, screen 333 AA women, and randomize 221 (M age =48.8±11.2; M BMI =36.7±8.4; 52% technical or high school) after collection of objective eligibility measures. A prospective, randomized, nested by church, design will be used to evaluate the faith-enhanced DPP as compared to a standard DPP on weight, diabetes and cardiovascular risk, over a 16-week intervention and 10-month follow up. This study will provide essential data to guide enhancements to evidence-based lifestyle programs for AA women who are at high risk for chronic disease. Copyright © 2017 Elsevier Inc. All rights reserved.

Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study: rationale and design for a randomized controlled trial evaluating rheumatoid arthritis risk education to first-degree relatives.

PubMed

Sparks, Jeffrey A; Iversen, Maura D; Miller Kroouze, Rachel; Mahmoud, Taysir G; Triedman, Nellie A; Kalia, Sarah S; Atkinson, Michael L; Lu, Bing; Deane, Kevin D; Costenbader, Karen H; Green, Robert C; Karlson, Elizabeth W

2014-09-01

We present the rationale, design features, and protocol of the Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study (ClinicalTrials.gov NCT02046005). The PRE-RA Family Study is an NIH-funded prospective, randomized controlled trial designed to compare the willingness to change behaviors in first-degree relatives of rheumatoid arthritis (RA) patients without RA after exposure to RA risk educational programs. Consented subjects are randomized to receive education concerning their personalized RA risk based on demographics, RA-associated behaviors, genetics, and biomarkers or to receive standard RA information. Four behavioral factors associated with RA risk were identified from prior studies for inclusion in the risk estimate: cigarette smoking, excess body weight, poor oral health, and low fish intake. Personalized RA risk information is presented through an online tool that collects data on an individual's specific age, gender, family history, and risk-related behaviors; presents genetic and biomarker results; displays relative and absolute risk of RA; and provides personalized feedback and education. The trial outcomes will be changes in willingness to alter behaviors from baseline to 6 weeks, 6 months, and 12 months in the three intervention groups. The design and the execution of this trial that targets a special population at risk for RA, while incorporating varied risk factors into a single risk tool, offer distinct challenges. We provide the theoretical rationale for the PRE-RA Family Study and highlight particular design features of this trial that utilize personalized risk education as an intervention. Copyright © 2014 Elsevier Inc. All rights reserved.

Randomized trial of anesthetic methods for intravitreal injections.

PubMed

Blaha, Gregory R; Tilton, Elisha P; Barouch, Fina C; Marx, Jeffrey L

2011-03-01

To compare the effectiveness of four different anesthetic methods for intravitreal injection. Twenty-four patients each received four intravitreal injections using each of four types of anesthesia (proparacaine, tetracaine, lidocaine pledget, and subconjunctival injection of lidocaine) in a prospective, masked, randomized block design. Pain was graded by the patient on a 0 to 10 scale for both the anesthesia and the injection. The average combined pain scores for both the anesthesia and the intravitreal injection were 4.4 for the lidocaine pledget, 3.5 for topical proparacaine, 3.8 for the subconjunctival lidocaine injection, and 4.1 for topical tetracaine. The differences were not significant (P = 0.65). There were also no statistical differences in the individual anesthesia or injection pain scores. Subconjunctival lidocaine injection had the most side effects. Topical anesthesia is an effective method for limiting pain associated with intravitreal injections.

Multifaceted Prospective Memory Intervention to Improve Medication Adherence.

PubMed

Insel, Kathie C; Einstein, Gilles O; Morrow, Daniel G; Koerner, Kari M; Hepworth, Joseph T

2016-03-01

To test whether a multifaceted prospective memory intervention improved adherence to antihypertensive medications and to assess whether executive function and working memory processes moderated the intervention effects. Two-group longitudinal randomized control trial. Community. Individuals aged 65 and older without signs of dementia or symptoms of severe depression who were self-managing prescribed medication. After 4 weeks of initial adherence monitoring using a medication event monitoring system, individuals with 90% or less adherence were randomly assigned to groups. The prospective memory intervention was designed to provide strategies that switch older adults from relying on executive function and working memory processes (that show effects of cognitive aging) to mostly automatic associative processes (that are relatively spared with normal aging) for remembering to take medications. Strategies included establishing a routine, establishing cues strongly associated with medication taking actions, performing the action immediately upon thinking about it, using a medication organizer, and imagining medication taking to enhance encoding and improve cuing. There was significant improvement in adherence in the intervention group (57% at baseline to 78% after the intervention), but most of these gains were lost after 5 months. The control condition started at 68% and was stable during the intervention, but dropped to 62%. Executive function and working memory moderated the intervention effect, with the intervention producing greater benefit for those with lower executive function and working memory. The intervention improved adherence, but the benefits were not sustained. Further research is needed to determine how to sustain the substantial initial benefits. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

Challenges of conducting a prospective clinical trial for older patients: Lessons learned from NCCTG N0949 (alliance).

PubMed

McCleary, Nadine J; Hubbard, Joleen; Mahoney, Michelle R; Meyerhardt, Jeffrey A; Sargent, Daniel; Venook, Alan; Grothey, Axel

2018-01-01

While the risk of developing colorectal cancer increases with age, there are limited prospective data regarding best treatment in the older adult population. We launched a phase III trial to evaluate difference in treatment outcome for older adults (aged ≥70years) with advanced colorectal cancer. Here we review the challenges faced and reasons for poor accrual to N0949. We describe the conceptualization, development and limited results of N0949, a randomized phase III study of fluoropyrimidine/bevacizumab with or without oxaliplatin (mFOLFOX7 or XELOX) as first line chemotherapy for metastatic colorectal cancer. Fluoropyrimidine was physician choice (e.g., 5-FU/LV or capecitabine). Of the projected 380 patients, only 32 patients were enrolled between the study activation in January 2011 until its closure in September 2012. Reasons for poor accrual included eligibility criteria that were too stringent, discomfort with randomizing older patients to regimens of varying intensity without considering their physical fitness, and discomfort with the use of bevacizumab in the older patient population. Several efforts were mounted to design a rationale and age-appropriate study, consider toxicities and varying study practices, and be responsive to stakeholder feedback. Challenges were experienced in conducting the first prospective phase III study evaluating progression-free survival of older adults with advanced colorectal cancer receiving palliative chemotherapy with fluoropyrimidine/bevacizumab with or without oxaliplatin in the USA. Future efforts to evaluate treatment outcomes in the older adult population should reflect on lessons learned in this large national effort. Copyright © 2017 Elsevier Inc. All rights reserved.

Sugar-sweetened beverages and weight gain in children and adults: a systematic review and meta-analysis123

PubMed Central

Pan, An; Willett, Walter C; Hu, Frank B

2013-01-01

Background: The relation between sugar-sweetened beverages (SSBs) and body weight remains controversial. Objective: We conducted a systematic review and meta-analysis to summarize the evidence in children and adults. Design: We searched PubMed, EMBASE, and Cochrane databases through March 2013 for prospective cohort studies and randomized controlled trials (RCTs) that evaluated the SSB-weight relation. Separate meta-analyses were conducted in children and adults and for cohorts and RCTs by using random- and fixed-effects models. Results: Thirty-two original articles were included in our meta-analyses: 20 in children (15 cohort studies, n = 25,745; 5 trials, n = 2772) and 12 in adults (7 cohort studies, n = 174,252; 5 trials, n = 292). In cohort studies, one daily serving increment of SSBs was associated with a 0.06 (95% CI: 0.02, 0.10) and 0.05 (95% CI: 0.03, 0.07)-unit increase in BMI in children and 0.22 kg (95% CI: 0.09, 0.34 kg) and 0.12 kg (95% CI: 0.10, 0.14 kg) weight gain in adults over 1 y in random- and fixed-effects models, respectively. RCTs in children showed reductions in BMI gain when SSBs were reduced [random and fixed effects: −0.17 (95% CI: −0.39, 0.05) and −0.12 (95% CI: −0.22, −0.2)], whereas RCTs in adults showed increases in body weight when SSBs were added (random and fixed effects: 0.85 kg; 95% CI: 0.50, 1.20 kg). Sensitivity analyses of RCTs in children showed more pronounced benefits in preventing weight gain in SSB substitution trials (compared with school-based educational programs) and among overweight children (compared with normal-weight children). Conclusion: Our systematic review and meta-analysis of prospective cohort studies and RCTs provides evidence that SSB consumption promotes weight gain in children and adults. PMID:23966427

A Randomized Prospective Trial Comparing Paravertebral Block and General Anesthesia for Operative Treatment of Breast Cancer

DTIC Science & Technology

2001-10-01

block the anesthetic of choice for operative treatment of breast cancer. To test this hypothesis we proposed a prospective randomized clinical trial ...coordinators. Months 4-6. Status: Complete The study’s existing part-time Clinical Trial Coordinator, Mr. John Arbo, was enlisted full-time in June...of full-time Clinical Trial Coordinator for Mount Sinai. ■ Poster presentation by Mount Sinai staff of study goals and methods at a Department of

Clinical Trials for Predictive Medicine—New Challenges and Paradigms*

PubMed Central

Simon, Richard

2014-01-01

Background Developments in biotechnology and genomics have increased the focus of biostatisticians on prediction problems. This has led to many exciting developments for predictive modeling where the number of variables is larger than the number of cases. Heterogeneity of human diseases and new technology for characterizing them presents new opportunities and challenges for the design and analysis of clinical trials. Purpose In oncology, treatment of broad populations with regimens that do not benefit most patients is less economically sustainable with expensive molecularly targeted therapeutics. The established molecular heterogeneity of human diseases requires the development of new paradigms for the design and analysis of randomized clinical trials as a reliable basis for predictive medicine[1, 2]. Results We have reviewed prospective designs for the development of new therapeutics with candidate predictive biomarkers. We have also outlined a prediction based approach to the analysis of randomized clinical trials that both preserves the type I error and provides a reliable internally validated basis for predicting which patients are most likely or unlikely to benefit from the new regimen. Conclusions Developing new treatments with predictive biomarkers for identifying the patients who are most likely or least likely to benefit makes drug development more complex. But for many new oncology drugs it is the only science based approach and should increase the chance of success. It may also lead to more consistency in results among trials and has obvious benefits for reducing the number of patients who ultimately receive expensive drugs which expose them risks of adverse events but no benefit. This approach also has great potential value for controlling societal expenditures on health care. Development of treatments with predictive biomarkers requires major changes in the standard paradigms for the design and analysis of clinical trials. Some of the key assumptions upon which current methods are based are no longer valid. In addition to reviewing a variety of new clinical trial designs for co-development of treatments and predictive biomarkers, we have outlined a prediction based approach to the analysis of randomized clinical trials. This is a very structured approach whose use requires careful prospective planning. It requires further development but may serve as a basis for a new generation of predictive clinical trials which provide the kinds of reliable individualized information which physicians and patients have long sought, but which have not been available from the past use of post-hoc subset analysis. PMID:20338899

Prevention of emergency physician migratory contamination in a cluster randomized trial to increase tissue plasminogen activator use in stroke (the INSTINCT trial).

PubMed

Weston, Victoria C; Meurer, William J; Frederiksen, Shirley M; Fox, Allison K; Scott, Phillip A

2014-12-01

Cluster randomized trials (CRTs) are increasingly used to evaluate quality improvement interventions aimed at health care providers. In trials testing emergency department (ED) interventions, migration of emergency physicians (EPs) between hospitals is an important concern, as contamination may affect both internal and external validity. We hypothesized that geographically isolating EDs would prevent migratory contamination in a CRT designed to increase ED delivery of tissue plasminogen activator (tPA) in stroke (the INSTINCT trial). INSTINCT was a prospective, cluster randomized, controlled trial. Twenty-four Michigan community hospitals were randomly selected in matched pairs for study. Contamination was defined at the cluster level, with substantial contamination defined a priori as greater than 10% of EPs affected. Nonadherence, total crossover (contamination+nonadherence), migration distance, and characteristics were determined. Three hundred seven EPs were identified at all sites. Overall, 7 (2.3%) changed study sites. One moved between control sites, leaving 6 (2.0%) total crossovers. Of these, 2 (0.7%) moved from intervention to control (contamination); and 4 (1.3%) moved from control to intervention (nonadherence). Contamination was observed in 2 of 12 control sites, with 17% and 9% contamination of the total site EP workforce at follow-up, respectively. Average migration distance was 42 miles for all EPs moving in the study and 35 miles for EPs moving from intervention to control sites. The mobile nature of EPs should be considered in the design of quality improvement CRTs. Increased reporting of contamination in CRTs is encouraged to clarify thresholds and facilitate CRT design. Copyright © 2014 Elsevier Inc. All rights reserved.

Design and implementation of a factorial randomized controlled trial of methadone maintenance therapy and an evidence-based behavioral intervention for incarcerated people living with HIV and opioid dependence in Malaysia.

PubMed

Bazazi, Alexander R; Wickersham, Jeffrey A; Wegman, Martin P; Culbert, Gabriel J; Pillai, Veena; Shrestha, Roman; Al-Darraji, Haider; Copenhaver, Michael M; Kamarulzaman, Adeeba; Altice, Frederick L

2017-08-01

Incarcerated people living with HIV and opioid dependence face enormous challenges to accessing evidence-based treatment during incarceration and after release into the community, placing them at risk of poor HIV treatment outcomes, relapse to opioid use and accompanying HIV transmission risk behaviors. Here we describe in detail the design and implementation of Project Harapan, a prospective clinical trial conducted among people living with HIV and opioid dependence who transitioned from prison to the community in Malaysia from 2010 to 2014. This trial involved 2 interventions: within-prison initiation of methadone maintenance therapy and an evidence-based behavioral intervention adapted to the Malaysian context (the Holistic Health Recovery Program for Malaysia, HHRP-M). Individuals were recruited and received the interventions while incarcerated and were followed for 12months after release to assess post-release HIV transmission risk behaviors and a range of other health-related outcomes. Project Harapan was designed as a fully randomized 2×2 factorial trial where individuals would be allocated in equal proportions to methadone maintenance therapy and HHRP-M, methadone maintenance therapy alone, HHRP-M alone, or control. Partway through study implementation, allocation to methadone maintenance therapy was changed from randomization to participant choice; randomization to HHRP-M continued throughout. We describe the justification for this study; the development and implementation of these interventions; changes to the protocol; and screening, enrollment, treatment receipt, and retention of study participants. Logistical, ethical, and analytic issues associated with the implementation of this study are discussed. Copyright © 2017 Elsevier Inc. All rights reserved.

A Multicenter, Prospective, Randomized Controlled Trial Evaluating the Efficacy of Rectal Diclofenac and Sublingual Nitroglycerin as a Combined Prophylactic Treatment for Post-ERCP Pancreatitis.

PubMed

Tomoda, Takeshi; Kato, Hironari; Mizukawa, Sho; Muro, Shinichiro; Akimoto, Yutaka; Uchida, Daisuke; Matsumoto, Kazuyuki; Yamamoto, Naoki; Horiguchi, Shigeru; Tsutsumi, Koichiro; Okada, Hiroyuki

2016-01-01

Acute pancreatitis is the major complication of endoscopic retrograde cholangiopancreatography (ERCP). A preliminary research suggested that the administration of nonsteroidal anti-inflammatory drugs (NSAIDs) with nitroglycerin might reduce the incidence of post-ERCP pancreatitis (PEP) more effectively than NSAIDs alone. We conduct a two-arm, multicenter, prospective, randomized, superiority trial to evaluate the additional effect of nitroglycerin for prevention of PEP. A total of 900 patients randomly receive 50 mg diclofenac suppository either alone or with 5 mg isosorbide dinitrate sublingual tablet. The primary endpoint is the occurrence of PEP. This study will clarify whether NSAIDs plus nitroglycerin can prevent PEP.

Hospital cost analysis of a prospective, randomized trial of early vs interval appendectomy for perforated appendicitis in children.

PubMed

Myers, Adrianne L; Williams, Regan F; Giles, Kim; Waters, Teresa M; Eubanks, James W; Hixson, S Douglas; Huang, Eunice Y; Langham, Max R; Blakely, Martin L

2012-04-01

The methods of surgical care for children with perforated appendicitis are controversial. Some surgeons prefer early appendectomy; others prefer initial nonoperative management followed by interval appendectomy. Determining which of these two therapies is most cost-effective was the goal of this study. We conducted a prospective, randomized trial in children with a preoperative diagnosis of perforated appendicitis. Patients were randomized to early or interval appendectomy. Overall hospital costs were extracted from the hospital's internal cost accounting system and the two treatment groups were compared using an intention-to-treat analysis. Nonparametric data were reported as median ± standard deviation (or range) and compared using a Wilcoxon rank sum test. One hundred thirty-one patients were randomized to either early (n = 64) or interval (n = 67) appendectomy. Hospital charges and costs were significantly lower in patients randomized to early appendectomy. Total median hospital costs were $17,450 (range $7,020 to $55,993) for patients treated with early appendectomy vs $22,518 (range $4,722 to $135,338) for those in the interval appendectomy group. Median hospital costs more than doubled in patients who experienced an adverse event ($15,245 vs $35,391, p < 0.0001). Unplanned readmissions also increased costs significantly and were more frequent in patients randomized to interval appendectomy. In a prospective randomized trial, hospital charges and costs were significantly lower for early appendectomy when compared with interval appendectomy. The increased costs were related primarily to the significant increase in adverse events, including unplanned readmissions, seen in the interval appendectomy group. Copyright © 2012. Published by Elsevier Inc.

Rationale and Design of the PROSPECTIVE Trial: Probucol Trial for Secondary Prevention of Atherosclerotic Events in Patients with Prior Coronary Heart Disease.

PubMed

Yamashita, Shizuya; Masuda, Daisaku; Ohama, Tohru; Arai, Hidenori; Bujo, Hideaki; Kagimura, Tatsuo; Kita, Toru; Matsuzaki, Masunori; Saito, Yasushi; Fukushima, Masanori; Matsuzawa, Yuji

2016-06-01

Reduction of serum LDL-cholesterol by statins was shown to improve clinical outcomes in patients with coronary heart disease (CHD). Although intensive statin therapy significantly reduced cardiovascular risks, atherosclerotic cardiovascular events have not been completely prevented. Therefore, effective pharmacologic therapy is necessary to improve "residual risks" in combination with statins. Probucol has a potent antioxidative effect, inhibits the oxidation of LDL, and reduces xanthomas. Probucol Trial for Secondary Prevention of Atherosclerotic Events in Patients with Prior Coronary Heart Disease (PROSPECTIVE) is a multicenter, randomized, prospective study designed to test the hypothesis that the addition of probucol to other lipid-lowering drugs will prevent cerebro- and cardiovascular events in patients with prior coronary events and high LDL cholesterol levels. The study will recruit approximately 860 patients with a prior CHD and dyslipidemia with LDL-C level ≥140 mg/dl without any medication and those treated with any lipid-lowering drugs with LDL-C level ≥100 mg/dl. Lipid-lowering agents are continuously administered during the study period in control group, and probucol (500 mg/day, 250 mg twice daily) is added to lipid-lowering therapy in the test group. The efficacy and safety of probucol with regard to the prevention of cerebro- and cardiovascular events and the intima-media thickness of carotid arteries as a surrogate marker will be evaluated. PROSPECTIVE will determine whether the addition of probucol to other lipid-lowering drugs improves cerebro- and cardiovascular outcomes in patients with prior coronary heart disease. Furthermore, the safety of a long-term treatment with probucol will be clarified.

Glutamine Randomized Studies in Early Life: The Unsolved Riddle of Experimental and Clinical Studies

PubMed Central

Briassouli, Efrossini; Briassoulis, George

2012-01-01

Glutamine may have benefits during immaturity or critical illness in early life but its effects on outcome end hardpoints are controversial. Our aim was to review randomized studies on glutamine supplementation in pups, infants, and children examining whether glutamine affects outcome. Experimental work has proposed various mechanisms of glutamine action but none of the randomized studies in early life showed any effect on mortality and only a few showed some effect on inflammatory response, organ function, and a trend for infection control. Although apparently safe in animal models (pups), premature infants, and critically ill children, glutamine supplementation does not reduce mortality or late onset sepsis, and its routine use cannot be recommended in these sensitive populations. Large prospectively stratified trials are needed to better define the crucial interrelations of “glutamine-heat shock proteins-stress response” in critical illness and to identify the specific subgroups of premature neonates and critically ill infants or children who may have a greater need for glutamine and who may eventually benefit from its supplementation. The methodological problems noted in the reviewed randomized experimental and clinical trials should be seriously considered in any future well-designed large blinded randomized controlled trial involving glutamine supplementation in critical illness. PMID:23019424

Syndesmotic fixation in supination-external rotation ankle fractures: a prospective randomized study.

PubMed

Pakarinen, Harri J; Flinkkilä, Tapio E; Ohtonen, Pasi P; Hyvönen, Pekka H; Lakovaara, Martti T; Leppilahti, Juhana I; Ristiniemi, Jukka Y

2011-12-01

This study was designed to assess whether transfixion of an unstable syndesmosis is necessary in supination-external rotation (Lauge-Hansen SE/Weber B)-type ankle fractures. A prospective study of 140 patients with unilateral Lauge-Hansen supination-external rotation type 4 ankle fractures was done. After bony fixation, the 7.5-Nm standardized external rotation (ER) stress test for both ankles was performed under fluoroscopy. A positive stress examination was defined as a difference of more than 2 mm side-to-side in the tibiotalar or tibiofibular clear spaces on mortise radiographs. If the stress test was positive, the patient was randomized to either syndesmotic transfixion with 3.5-mm tricortical screws or no syndesmotic fixation. Clinical outcome was assessed using the Olerud-Molander scoring system, RAND 36-Item Health Survey, and Visual Analogue Scale (VAS) to measure pain and function after a minimum 1-year of followup. Twenty four (17%) of 140 patients had positive standardized 7.5-Nm ER stress tests after malleolar fixation. The stress view was positive three times on tibiotalar clear space, seven on tibiofibular clear space, and 14 times on both tibiotalar and tibiofibular clear spaces. There was no significant difference between the two randomization groups with regards to Olerud-Molander functional score, VAS scale measuring pain and function, or RAND 36-Item Health Survey pain or physical function at 1 year. Relevant syndesmotic injuries are rare in supination-external rotation ankle fractures, and syndesmotic transfixion with a screw did not influence the functional outcome or pain after the 1-year followup compared with no fixation.

The Effect of Patella Eversion on Clinical Outcome Measures in Simultaneous Bilateral Total Knee Arthroplasty: A Prospective Randomized Controlled Trial.

PubMed

Zan, Pengfei; Wu, Zhong; Yu, Xiao; Fan, Lin; Xu, Tianyang; Li, Guodong

2016-03-01

During total knee arthroplasty (TKA), surgical exposure requires mobilization technique of the patella. With this trial, we intended to investigate the effect of patella eversion on clinical outcome measures in simultaneous bilateral TKA. We prospectively enrolled 44 patients (88 knees) from April 2008 to June 20l4.One knee was operated with patella eversion (group A) and the other with patella lateral retraction (group B) randomly. Follow-up results, including the operation time, complications, and the time of achieving straight leg raise (SLR) and 90° knee flexion, were recorded. The data of range of motion (ROM) and Visual Analogue Scale score were collected separately at 7 days, 3 months, 6 months, and 1 year postoperatively. The time of achieving SLR was 2.7 ± 0.8 days in group A and 2.1 ± 0.7 DAYS in group B, which were significantly different (P = .032). Significant difference was found on active and passive ROM during the follow-up times between groups A and B, except the passive ROM at 6 months postoperatively. No significant difference was found on operation time, complications, patella baja or tilt, time of achieving 90°knee flexion, and Visual Analogue Scale score during the follow-up times. Patellar eversion was adverse to the early knee function recovery after TKA; it would delay the time of achieving SLR and decrease the passive and active ROM. In addition, more carefully and scientifically designed randomized controlled trials are still required to further prove the claim. Copyright © 2016 Elsevier Inc. All rights reserved.

Consumption of fruit and vegetables reduces risk of pancreatic cancer: evidence from epidemiological studies.

PubMed

Wu, Qi-Jun; Wu, Lang; Zheng, Li-Qiang; Xu, Xin; Ji, Chao; Gong, Ting-Ting

2016-05-01

Observational studies have reported inconsistent results on the association between fruit and vegetable intake and the risk of pancreatic cancer. We carried out a meta-analysis of epidemiological studies to summarize available evidence. We searched PubMed, Scopus, and ISI Web of Science databases for relevant studies published until the end of January 2015. Fixed-effects and random-effects models were used to estimate the summary relative risks (RRs) and 95% confidence intervals (CIs) for the associations between fruit and vegetable intake and the risk of pancreatic cancer. A total of 15 case-control studies, eight prospective studies, and one pooled analysis fulfilled the inclusion criteria. The summary RR for the highest versus the lowest intake was 0.73 (95% CI=0.53-1.00) for fruit and vegetables, 0.73 (95% CI=0.63-0.84) for fruit, and 0.76 (95% CI=0.69-0.83) for vegetables, with significant heterogeneities (I=70.5, 55.7, and 43.0%, respectively). Inverse associations were observed in the stratified analysis by study design, although the results of prospective studies showed borderline significance, with corresponding RR=0.90 (95% CI=0.77-1.05) for fruit and vegetable intake, 0.93 (95% CI=0.83-1.03) for fruit intake, and 0.89 (95% CI=0.80-1.00) for vegetable intake. Besides, significant inverse associations were observed in the majority of other subgroup analyses by study quality, geographic location, exposure assessment method, and adjustment for potential confounders. Findings from the present meta-analysis support that fruit and vegetable intake is associated inversely with the risk of pancreatic cancer. However, study design may play a key role in the observed magnitude of the aforementioned association. Future well-designed prospective studies are warranted to confirm these findings.

The Perception on Fundamentals of Online Courses: A Case on Prospective Instructional Designers

ERIC Educational Resources Information Center

Genç, Zülfü; Tinmaz, Hasan

2016-01-01

This study focuses on prospective instructional designers' perception toward creating online courses including which elements are essential for developing such platforms. The study is significant for revealing what the prospective instructional designers focus on while they design certain learning opportunities. The participants of the study were…

Design and Rationale of the Intima-Medial Thickness Sub-Study of the PreventIon of CArdiovascular Events in iSchemic Stroke Patients with High Risk of Cerebral hemOrrhage (PICASSO-IMT) Study.

PubMed

Seo, Woo-Keun; Kim, Yong Jae; Lee, Juneyoung; Kwon, Sun U

2017-09-01

Atherosclerosis is one of the main mechanisms of stroke and cardiovascular diseases and is associated with increased risk of recurrent stroke and cardiovascular events. Intima-medial thickness (IMT) is a well-known surrogate marker of atherosclerosis and has been used to predict stroke and cardiovascular events. However, the clinical significance of IMT and IMT change in stroke has not been investigated in well-designed studies. The PreventIon of CArdiovascular events in iSchemic Stroke patients with high risk of cerebral hemOrrhage-Intima-Media Thickness (PICASSO-IMT) sub-study is designed to investigate the effects of cilostazol, probucol, or both on IMT in patients with stroke. PICASSO-IMT is a prospective sub-study of the PICASSO study designed to measure IMT and plaque score at 1, 13, 25, 37, and 49 months after randomization. The primary outcome is the change in mean carotid IMT, which is defined as the mean of the far-wall IMTs of the right and left common carotid arteries, between baseline and 13 months after randomization. PICASSO-IMT will provide the largest IMT data set in a stroke population and will provide valuable information about the clinical significance of IMT in patients with ischemic stroke. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

A randomized controlled trial of culturally adapted motivational interviewing for Hispanic heavy drinkers: Theory of Adaptation and Study Protocol

PubMed Central

Lee, Christina S.; Colby, Suzanne M.; Magill, Molly; Almeida, Joanna; Tavares, Tonya; Rohsenow, Damaris J.

2016-01-01

Background The NIH Strategic Plan prioritizes health disparities research for socially disadvantaged Hispanics, to reduce the disproportionate burden of alcohol-related negative consequences compared to other racial/ethnic groups. Cultural adaptation of evidence-based treatments, such as motivational interviewing (MI), can improve access and response to alcohol treatment. However, the lack of rigorous clinical trials designed to test the efficacy and theoretical underpinnings of cultural adaptation has made proof of concept difficult. Objective The CAMI2 (Culturally Adapted Motivational Interviewing) study design and its theoretical model, is described to illustrate how MI adapted to social and cultural factors (CAMI) can be discriminated against non-adapted MI. Methods and Design CAMI2, a large, 12 month randomized prospective trial, examines the efficacy of CAMI and MI among heavy drinking Hispanics recruited from the community (n=257). Outcomes are reductions in heavy drinking days (Time Line Follow-Back) and negative consequences of drinking among Hispanics (Drinkers Inventory of Consequences). A second aim examines perceived acculturation stress as a moderator of treatment outcomes in the CAMI condition. Summary The CAMI2 study design protocol is presented and the theory of adaptation is presented. Findings from the trial described may yield important recommendations on the science of cultural adaptation and improve MI dissemination to Hispanics with alcohol risk. PMID:27565832

Glyburide Advantage in Malignant Edema and Stroke (GAMES-RP) Trial: Rationale and Design.

PubMed

Sheth, Kevin N; Elm, Jordan J; Beslow, Lauren A; Sze, Gordon K; Kimberly, W Taylor

2016-02-01

Patients with large territory infarction are at high risk of cerebral edema and neurological deterioration, including death. Preclinical studies have shown that a continuous infusion of glyburide blocks edema formation and improves outcome. We hypothesize that treatment with RP-1127 (Glyburide for Injection) reduces formation of brain edema in patients after large anterior circulation infarction. GAMES-RP is a prospective, randomized, double-blind, multicenter trial designed to evaluate RP-1127 in patients at high risk for the development of malignant cerebral edema. The study population consisted of subjects with a clinical diagnosis of acute severe anterior circulation ischemic stroke with a baseline diffusion-weighted image lesion between 82 and 300 cm(3) who are 18-80 years of age. The target time from symptom onset to start of study infusion was ≤10 h. Subjects were randomized to RP-1127 (glyburide for injection) or placebo and treated with a continuous infusion for 72 h. The primary efficacy outcome was a composite of the modified Rankin Scale and the incidence of decompressive craniectomy, assessed at 90 days. Safety outcomes were the frequency and severity of adverse events, with a focus on cardiac- and glucose-related serious adverse events. GAMES-RP was designed to provide critical information regarding glyburide for injection in patients with large hemispheric stroke and will inform the design of future studies.

Clinical Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): A Pragmatic Trial of Complex Treatment for a Complex Disorder

PubMed Central

Nierenberg, Andrew A.; Sylvia, Louisa G.; Leon, Andrew C.; Reilly-Harrington, Noreen; Shesler, Leah W.; McElroy, Susan L.; Friedman, Edward S.; Thase, Michael E.; Shelton, Richard C.; Bowden, Charles; Tohen, Mauricio; Singh, Vivek; Deckersbach, Thilo; Ketter, Terence; Kocsis, James; McInnis, Melvin G.; Schoenfeld, David; Bobo, William V.; Calabrese, Joseph R.

2015-01-01

Background Classic and second generation antipsychotic mood stabilizers are recommended for treatment of bipolar disorder, yet there are no randomized comparative effectiveness studies that have examined the “real-world” advantages and disadvantages of these medications Purpose We describe the strategic decisions in the design of the Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE). This paper outlines the key issues and solutions the investigators faced in designing a clinical trial that would maximize generalizability and inform real-world clinical treatment of bipolar disorder. Methods Bipolar CHOICE was a 6-month, multi-site, prospective, randomized clinical trial of outpatients with bipolar disorder. This study compares the effectiveness of quetiapine versus lithium, each with adjunctive personalized treatments. The co-primary outcomes selected are the overall benefits and harms of the study medications (as measured by the Clinical Global Impression-Efficacy Index) and the Necessary Clinical Adjustments (a measure of the number of medication changes). Secondary outcomes are continuous measures of mood, the Framingham General Cardiovascular Risk Score and the Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool. Results The final study design consisted of a single-blind, randomized comparative effectiveness trial of quetiapine versus lithium, plus adjunctive personalized treatment (APT), across ten sites. Other important study considerations included limited exclusion criteria to maximize generalizability, flexible dosing of APT medications to mimic real-world treatment, and an intent-to-treat analysis plan. 482 participants were randomized to the study and 364 completed. Limitations The potential limitations of the study include the heterogeneity of APT, selection of study medications, lack of a placebo-control group, and participants’ ability to pay for study medications. Conclusion We expect that this study will inform our understanding of the benefits and harms of lithium, a classic mood stabilizer, compared to quetiapine, a second generation antipsychotic with broad-spectrum activity in bipolar disorder and will provide an example of a well-designed and well-conducted randomized comparative effectiveness clinical trial. PMID:24346608

Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): a pragmatic trial of complex treatment for a complex disorder.

PubMed

Nierenberg, Andrew A; Sylvia, Louisa G; Leon, Andrew C; Reilly-Harrington, Noreen A; Shesler, Leah W; McElroy, Susan L; Friedman, Edward S; Thase, Michael E; Shelton, Richard C; Bowden, Charles L; Tohen, Mauricio; Singh, Vivek; Deckersbach, Thilo; Ketter, Terence A; Kocsis, James H; McInnis, Melvin G; Schoenfeld, David; Bobo, William V; Calabrese, Joseph R

2014-02-01

Classic and second-generation antipsychotic mood stabilizers are recommended for treatment of bipolar disorder, yet there are no randomized comparative effectiveness studies that have examined the 'real-world' advantages and disadvantages of these medications. We describe the strategic decisions in the design of the Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE). This article outlines the key issues and solutions the investigators faced in designing a clinical trial that would maximize generalizability and inform real-world clinical treatment of bipolar disorder. Bipolar CHOICE was a 6-month, multi-site, prospective, randomized clinical trial of outpatients with bipolar disorder. This study compares the effectiveness of quetiapine versus lithium, each with adjunctive personalized treatments (APTs). The co-primary outcomes selected are the overall benefits and harms of the study medications (as measured by the Clinical Global Impression-Efficacy Index) and the Necessary Clinical Adjustments (a measure of the number of medication changes). Secondary outcomes are continuous measures of mood, the Framingham General Cardiovascular Risk Score, and the Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT). The final study design consisted of a single-blind, randomized comparative effectiveness trial of quetiapine versus lithium, plus APT, across 10 sites. Other important study considerations included limited exclusion criteria to maximize generalizability, flexible dosing of APT medications to mimic real-world treatment, and an intent-to-treat analysis plan. In all, 482 participants were randomized to the study, and 364 completed the study. The potential limitations of the study include the heterogeneity of APT, selection of study medications, lack of a placebo-control group, and participants' ability to pay for study medications. We expect that this study will inform our understanding of the benefits and harms of lithium, a classic mood stabilizer, compared to quetiapine, a second-generation antipsychotic with broad-spectrum activity in bipolar disorder, and will provide an example of a well-designed and well-conducted randomized comparative effectiveness clinical trial.

Hypnosis and Local Anesthesia for Dental Pain Relief-Alternative or Adjunct Therapy?-A Randomized, Clinical-Experimental Crossover Study.

PubMed

Wolf, Thomas Gerhard; Wolf, Dominik; Callaway, Angelika; Below, Dagna; d'Hoedt, Bernd; Willershausen, Brita; Daubländer, Monika

2016-01-01

This prospective randomized clinical crossover trial was designed to compare hypnosis and local anesthesia for experimental dental pain relief. Pain thresholds of the dental pulp were determined. A targeted standardized pain stimulus was applied and rated on the Visual Analogue Scale (0-10). The pain threshold was lower under hypnosis (58.3 ± 17.3, p < .001), maximal (80.0) under local anesthesia. The pain stimulus was scored higher under hypnosis (3.9 ± 3.8) than with local anesthesia (0.0, p < .001). Local anesthesia was superior to hypnosis and is a safe and effective method for pain relief in dentistry. Hypnosis seems to produce similar effects observed under sedation. It can be used in addition to local anesthesia and in individual cases as an alternative for pain control in dentistry.

Findings From a Prospective Randomized Controlled Trial of an Individualized Music Listening Program for Persons With Dementia.

PubMed

Kwak, Jung; Anderson, Keith; O'Connell Valuch, Katharine

2018-06-01

Music & Memory (M&M) is a passive music intervention that uses personalized music playlists delivered on digital music players. This program has been increasingly adopted in nursing homes across the United States to facilitate communication, engagement, and socialization among persons with dementia (PWDs); however, few studies have evaluated the program's effect on PWDs' outcomes. In the present study, a randomized controlled crossover design was used to examine the impact of the M&M program on 59 PWDs in 10 nursing homes over a 14-week period. Residents' evaluated outcomes included agitation, behavioral symptoms, and use of psychotropic medications. Although trends supported the positive effects of M&M, no statistically significant differences were found in any of the outcomes measured over time. Methodological limitations withstanding, these findings call into question the effectiveness of the M&M program and the ability of facility staff to implement this intervention with fidelity.

Commentary on Sommer et al. 'A randomized experiment of the effects of including alternative medicine in the mandatory benefit package of health insurance.

PubMed

Heusser, P

2000-03-01

The study by Sommer et al. recently reported in Complementary Therapies in Medicine has been heavily criticised in Switzerland since its original publication. Its major problems are an inadequate reflection of real practice, an inadequate study design relative to the central research objective, questionable value of the applied instrument and procedure for health assessment, methodological and statistical problems, and failure to consider literature relevant to the topic. For these reasons, this experimental study does not allow an answer to its central questions as to costs and effectiveness of complementary medicine made available within Switzerland's mandatory basic health insurance provisions. We propose more practice-related, non-experimental prospective study designs to realistically answer these questions.

Perioperative ketorolac in high risk breast cancer patients. Rationale, feasibility and methodology of a prospective randomized placebo-controlled trial.

PubMed

Forget, Patrice; Berlière, Martine; van Maanen, Aline; Duhoux, Francois P; Machiels, Jean-Pascal; Coulie, Pierre G; Bouche, Gauthier; De Kock, Marc

2013-10-01

Ketorolac, a NSAID routinely used during surgery proposed to have anticancer effects, is a promising way to improve postoperative oncological outcome. This effect may be particularly prominent in patients with elevated preoperative inflammatory scores, like the neutrophil:lymphocyte ratio. In this paper, we describe the rationale, the preliminary analyses in our patients, the feasibility and the methodology of a prospective randomized trial called "Ketorolac in Breast Cancer trial" (KBCt) (NCT01806259). Copyright © 2013 Elsevier Ltd. All rights reserved.

Methodology Series Module 1: Cohort Studies

PubMed Central

Setia, Maninder Singh

2016-01-01

Cohort design is a type of nonexperimental or observational study design. In a cohort study, the participants do not have the outcome of interest to begin with. They are selected based on the exposure status of the individual. They are then followed over time to evaluate for the occurrence of the outcome of interest. Some examples of cohort studies are (1) Framingham Cohort study, (2) Swiss HIV Cohort study, and (3) The Danish Cohort study of psoriasis and depression. These studies may be prospective, retrospective, or a combination of both of these types. Since at the time of entry into the cohort study, the individuals do not have outcome, the temporality between exposure and outcome is well defined in a cohort design. If the exposure is rare, then a cohort design is an efficient method to study the relation between exposure and outcomes. A retrospective cohort study can be completed fast and is relatively inexpensive compared with a prospective cohort study. Follow-up of the study participants is very important in a cohort study, and losses are an important source of bias in these types of studies. These studies are used to estimate the cumulative incidence and incidence rate. One of the main strengths of a cohort study is the longitudinal nature of the data. Some of the variables in the data will be time-varying and some may be time independent. Thus, advanced modeling techniques (such as fixed and random effects models) are useful in analysis of these studies. PMID:26955090

Methodology Series Module 1: Cohort Studies.

PubMed

Setia, Maninder Singh

2016-01-01

Cohort design is a type of nonexperimental or observational study design. In a cohort study, the participants do not have the outcome of interest to begin with. They are selected based on the exposure status of the individual. They are then followed over time to evaluate for the occurrence of the outcome of interest. Some examples of cohort studies are (1) Framingham Cohort study, (2) Swiss HIV Cohort study, and (3) The Danish Cohort study of psoriasis and depression. These studies may be prospective, retrospective, or a combination of both of these types. Since at the time of entry into the cohort study, the individuals do not have outcome, the temporality between exposure and outcome is well defined in a cohort design. If the exposure is rare, then a cohort design is an efficient method to study the relation between exposure and outcomes. A retrospective cohort study can be completed fast and is relatively inexpensive compared with a prospective cohort study. Follow-up of the study participants is very important in a cohort study, and losses are an important source of bias in these types of studies. These studies are used to estimate the cumulative incidence and incidence rate. One of the main strengths of a cohort study is the longitudinal nature of the data. Some of the variables in the data will be time-varying and some may be time independent. Thus, advanced modeling techniques (such as fixed and random effects models) are useful in analysis of these studies.

Improving Language Comprehension in Preschool Children with Language Difficulties: A Cluster Randomized Trial

ERIC Educational Resources Information Center

Hagen, Åste M.; Melby-Lervåg, Monica; Lervåg, Arne

2017-01-01

Background: Children with language comprehension difficulties are at risk of educational and social problems, which in turn impede employment prospects in adulthood. However, few randomized trials have examined how such problems can be ameliorated during the preschool years. Methods: We conducted a cluster randomized trial in 148 preschool…

Comparative Efficacy and Durability of Continuation Phase Cognitive Therapy for Preventing Recurrent Depression: Design of a Double-Blinded, Fluoxetine- and Pill-Placebo–Controlled, Randomized Trial with 2-Year Follow-up

PubMed Central

Thase, Michael E.

2010-01-01

Background Major depressive disorder (MDD) is highly prevalent and associated with disability and chronicity. Although cognitive therapy (CT) is an effective short-term treatment for MDD, a significant proportion of responders subsequently suffer relapses or recurrences. Purpose This design prospectively evaluates: 1) a method to discriminate CT-treated responders at lower versus higher risk for relapse; and 2) the subsequent durability of 8-month continuation phase therapies in randomized higher risk responders followed for an additional 24-months. The primary prediction is: after protocol treatments are stopped, higher risk patients randomly assigned to continuation phase CT (C-CT) will have a lower risk of relapse/recurrence than those randomized to fluoxetine (FLX). Methods Outpatients, aged 18 to 70 years, with recurrent MDD received 12–14 weeks of CT provided by 15 experienced therapists from two sites. Responders (i.e., no MDD and 17-item Hamilton Rating Scale for Depression ≤ 12) were stratified into higher and lower risk groups based on stability of remission during the last 6 weeks of CT. The lower risk group entered follow-up for 32 months; the higher risk group was randomized to 8 months of continuation phase therapy with either C-CT or clinical management plus either double-blinded FLX or pill placebo. Following the continuation phase, higher risk patients were followed by blinded evaluators for 24 months. Results The trial began in 2000. Enrollment is complete (N=523). The follow-up continues. Conclusions The trial evaluates the preventive effects and durability of acute and continuation phase treatments in the largest known sample of CT responders collected worldwide. PMID:20451668

Primary prevention of stroke and cardiovascular disease in the community (PREVENTS): Methodology of a health wellness coaching intervention to reduce stroke and cardiovascular disease risk, a randomized clinical trial.

PubMed

Mahon, Susan; Krishnamurthi, Rita; Vandal, Alain; Witt, Emma; Barker-Collo, Suzanne; Parmar, Priya; Theadom, Alice; Barber, Alan; Arroll, Bruce; Rush, Elaine; Elder, Hinemoa; Dyer, Jesse; Feigin, Valery

2018-02-01

Rationale Stroke is a major cause of death and disability worldwide, yet 80% of strokes can be prevented through modifications of risk factors and lifestyle and by medication. While management strategies for primary stroke prevention in high cardiovascular disease risk individuals are well established, they are underutilized and existing practice of primary stroke prevention are inadequate. Behavioral interventions are emerging as highly promising strategies to improve cardiovascular disease risk factor management. Health Wellness Coaching is an innovative, patient-focused and cost-effective, multidimensional psychological intervention designed to motivate participants to adhere to recommended medication and lifestyle changes and has been shown to improve health and enhance well-being. Aims and/or hypothesis To determine the effectiveness of Health Wellness Coaching for primary stroke prevention in an ethnically diverse sample including Māori, Pacific Island, New Zealand European and Asian participants. Design A parallel, prospective, randomized, open-treatment, single-blinded end-point trial. Participants include 320 adults with absolute five-year cardiovascular disease risk ≥ 10%, calculated using the PREDICT web-based clinical tool. Randomization will be to Health Wellness Coaching or usual care groups. Participants randomized to Health Wellness Coaching will receive 15 coaching sessions over nine months. Study outcomes A substantial relative risk reduction of five-year cardiovascular disease risk at nine months post-randomization, which is defined as 10% relative risk reduction among those at moderate five-year cardiovascular disease risk (10-15%) and 25% among those at high risk (>15%). Discussion This clinical trial will determine whether Health Wellness Coaching is an effective intervention for reducing modifiable risk factors, and hence decrease the risk of stroke and cardiovascular disease.

Patients' ability to treat anaphylaxis using adrenaline autoinjectors: a randomized controlled trial.

PubMed

Umasunthar, T; Procktor, A; Hodes, M; Smith, J G; Gore, C; Cox, H E; Marrs, T; Hanna, H; Phillips, K; Pinto, C; Turner, P J; Warner, J O; Boyle, R J

2015-07-01

Previous work has shown patients commonly misuse adrenaline autoinjectors (AAI). It is unclear whether this is due to inadequate training, or poor device design. We undertook a prospective randomized controlled trial to evaluate ability to administer adrenaline using different AAI devices. We allocated mothers of food-allergic children prescribed an AAI for the first time to Anapen or EpiPen using a computer-generated randomization list, with optimal training according to manufacturer's instructions. After one year, participants were randomly allocated a new device (EpiPen, Anapen, new EpiPen, JEXT or Auvi-Q), without device-specific training. We assessed ability to deliver adrenaline using their AAI in a simulated anaphylaxis scenario six weeks and one year after initial training, and following device switch. Primary outcome was successful adrenaline administration at six weeks, assessed by an independent expert. Secondary outcomes were success at one year, success after switching device, and adverse events. We randomized 158 participants. At six weeks, 30 of 71 (42%) participants allocated to Anapen and 31 of 73 (43%) participants allocated to EpiPen were successful - RR 1.00 (95% CI 0.68-1.46). Success rates at one year were also similar, but digital injection was more common at one year with EpiPen (8/59, 14%) than Anapen (0/51, 0%, P = 0.007). When switched to a new device without specific training, success rates were higher with Auvi-Q (26/28, 93%) than other devices (39/80, 49%; P < 0.001). AAI device design is a major determinant of successful adrenaline administration. Success rates were low with several devices, but were high using the audio-prompt device Auvi-Q. © 2015 The Authors Allergy Published by John Wiley & Sons Ltd.

Effect of number and position of intraocular lens haptics on anterior capsule contraction: a randomized, prospective trial.

PubMed

Choi, Mihyun; Lazo, Marjorie Z; Kang, Minji; Lee, Jeehye; Joo, Choun-Ki

2018-03-20

The present study aimed to evaluate the degree of anterior capsule contraction (capsulorhexis contraction) with three different single-piece, hydrophilic acrylic intraocular lenses (IOLs). Patients were prospectively randomized to be implanted with one of three types of IOLs during cataract surgery: the Ophtec Precizon (IOL A), the Lucid Korea Microflex (IOL B), and the Carl Zeiss Asphina (IOL C). One week, 2 weeks, and 6 months after surgery, the area of the anterior capsule opening was measured using digital retro-illumination images after dilation of the pupil. The data were then evaluated using POCOman software. The study included 236 eyes of 202 patients. The area of the anterior capsule opening reduced by 3.53 ± 3.31 mm (17.06% ± 15.99%) between 1 week and 2 months post-operatively in the IOL A group, by 0.62 ± 1.32 mm (2.87% ± 6.03%) in the IOL B group, and by 1.09 ± 1.53 mm (4.72% ± 6.10%) in the IOL C group. The IOL B group showed minimal anterior capsule contraction 2 months after surgery (p < 0.001). IOLs with a four-plate haptic design (IOL B) showed more anterior capsular stability than those with a two-loop plate haptic (IOL A) or two-plate haptic (IOL C) design. The number and position of haptics in a capsular bag may affect anterior capsule contraction. We assume that supporting the zonules evenly may play a role in anterior capsular stability. Current Controlled Trials ISRCTN76566080 , Retrospectively registered (Date of registration: 14 Feb 2018).

Prospective, randomized comparison of a prototype endoscope with deflecting working channels versus a conventional double-channel endoscope for rectal endoscopic submucosal dissection in an established experimental simulation model (with video).

PubMed

Jung, Yunho; Kato, Masayuki; Lee, Jongchan; Gromski, Mark A; Chuttani, Ram; Matthes, Kai

2013-11-01

A prototype endoscope was designed to improve visualization and dissection of tissue with the use of 2 working channels with different deflections. To evaluate the efficacy and operability of a prototype endoscope in comparison with a conventional double-channel endoscope for rectal endoscopic submucosal dissection (ESD). Randomized, prospective, controlled, ex vivo study. Academic medical center. A total of 80 standardized artificial lesions measuring 3 × 3 cm were created approximately 5 cm from the anal verge in fresh ex vivo porcine colorectal specimens. Two endoscopists each completed 20 cases with the prototype endoscope and 20 cases with the conventional endoscope. An independent observer recorded procedure time, specimen size, en bloc resection, and perforation rate. For the ESD novice, the mean submucosal dissection time (10.5 ± 3.8 vs 14.9 ± 7.3 minutes; P = .024) and total procedure time (18.1 ± 5.2 vs 23.6 ± 8.2 minutes; P = .015) were significantly shorter in the prototype group in comparison with the conventional group. For the ESD expert, there was no significant difference between the mean circumferential resection, submucosal dissection, and total procedure time (prototype group 14.2 ± 6.0 minutes, conventional group 14.2 ± 8.8 minutes; P = .992). The overall perforation and en bloc resection rates were not significantly different between groups. Ex vivo study. In this ex vivo prospective comparison study, there was a technical advantage for the ESD novice with the prototype endoscope that resulted in a shorter procedure time, which was not observed for cases performed by the ESD expert. Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Arthroscopic Surgical Procedures Versus Sham Surgery for Patients With Femoroacetabular Impingement and/or Labral Tears: Study Protocol for a Randomized Controlled Trial (HIPARTI) and a Prospective Cohort Study (HARP).

PubMed

Risberg, May Arna; Ageberg, Eva; Nilstad, Agnethe; Lund, Bent; Nordsletten, Lars; Løken, Sverre; Ludvigsen, Tom; Kierkegaard, Signe; Carsen, Sasha; Kostogiannis, Ioannis; Crossley, Kay M; Glyn-Jones, Sion; Kemp, Joanne L

2018-04-01

Study Design Study protocol for a randomized controlled trial and a prospective cohort. Background The number of arthroscopic surgical procedures for patients with femoroacetabular impingement syndrome (FAIS) has significantly increased worldwide, but high-quality evidence of the effect of such interventions is lacking. Objectives The primary objective will be to determine the efficacy of hip arthroscopic procedures compared to sham surgery on patient-reported outcomes for patients with FAIS (HIP ARThroscopy International [HIPARTI] Study). The secondary objective will be to evaluate prognostic factors for long-term outcome after arthroscopic surgical interventions in patients with FAIS (Hip ARthroscopy Prospective [HARP] Study). Methods The HIPARTI Study will include 140 patients and the HARP Study will include 100 patients. The international Hip Outcome Tool-33 will be the primary outcome measure at 1 year. Secondary outcome measures will be the Hip disability and Osteoarthritis Outcome Score, Arthritis Self-Efficacy Scale, fear of movement (Tampa Scale of Kinesiophobia), Patient-Specific Functional Scale, global rating of change score, and expectations. Other outcomes will include active hip range of motion, hip muscle strength tests, functional performance tests, as well as radiological assessments using radiographs and magnetic resonance imaging. Conclusion To determine the true effect of surgery, beyond that of placebo, double-blinded placebo-controlled trials including sham surgery are needed. The HIPARTI Study will direct future evidence-based treatment of FAIS. Predictors for long-term development and progression of degenerative changes in the hip are also needed for this young patient group with FAIS; hence, responders and nonresponders to treatment could be determined. J Orthop Sports Phys Ther 2018;48(4):325-335. doi:10.2519/jospt.2018.7931.

Social Media and Peer-Reviewed Medical Journal Readership: A Randomized Prospective Controlled Trial.

PubMed

Hawkins, C Matthew; Hunter, Makeba; Kolenic, Giselle E; Carlos, Ruth C

2017-05-01

To prospectively evaluate the impact of increasing levels of social media engagement on page visits and web-link clicks for content published in the Journal of the American College of Radiology. A three-arm prospective trial was designed using a control group, a basic Twitter intervention group (using only the Journal's @JACRJournal Twitter account), and an enhanced Twitter intervention group (using the personal Twitter accounts of editorial board members and trainees). Overall, 428 articles published between June 2013 and July 2015 were randomly assigned to the three groups. Article-specific tweets for both intervention arms were sent between September 14, 2015, and October 28, 2015. Primary end points included article-specific weekly and monthly page visits on the journal's Elsevier website (Amsterdam, Netherlands). For the two intervention groups, additional end points included 7-day and 30-day Twitter link clicks. Weekly page visits for the enhanced Twitter arm (mean 18.2; 95% confidence interval [CI] 15.6-20.7) were significantly higher when compared with the weekly page visits for the control arm (mean 7.6; 95% CI 1.7-13.6). However, there was no demonstrable increase in weekly page visits (mean 9.4; 95% CI 7.4-11.5) for the basic Twitter arm compared with the control arm. No intervention effects over control, regardless of Twitter arm assignment, were demonstrated for monthly page visits. The enhanced Twitter intervention resulted in a statistically significant increase in both 7-day and 30-day Twitter link clicks compared with the basic Twitter intervention group. An organized social media strategy, with focused social media activity from editorial board members, increased engagement with content published in a peer-reviewed radiology journal. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Effect of ice on pain after corticosteroid injection in the hand and wrist: a randomized controlled trial.

PubMed

An, T W; Boone, S L; Boyer, M I; Gelberman, R H; Osei, D A; Calfee, R P

2016-11-01

This prospective, randomized controlled study was designed to determine if applying ice to the site of corticosteroid injections in the hand and wrist reduces post-injection pain. Patients receiving corticosteroid injections in the hand or wrist at a tertiary institution were enrolled. Subjects were randomized to apply ice to the injection site and take scheduled over-the-counter analgesics ( n = 36) or take scheduled over-the-counter analgesics alone ( n = 32). There were no significant differences in the mean pain score between the two groups at any time-point (pre-injection or 1-5 days post-injection). In regression modelling, the application of ice did not predict pain after injection. Visual analogue pain scores increased at least 2 points (0-10 scale) after injection in 17 out of 36 patients in the ice group versus ten out of 32 control patients. We conclude that the application of ice in addition to over-the-counter analgesics does not reduce post-injection pain after corticosteroid injection in the hand or wrist. I Therapeutic Study.

Considerations of study design.

PubMed

Koretz, Ronald L

2007-12-01

Research projects attempt to answer specific questions. The particular study design that is selected will depend in large measure on the nature of the question and the time and resources available. There are 5 common categories of clinical questions; they relate to etiology, prognosis, utility of diagnostic tests, efficacy of proposed interventions, and cost of treatment in specific disease states. A number of study designs can be used. Case reports serve to memorialize unusual or novel aspects of diseases. Retrospective case series are useful for defining natural history. Case-control studies are used by epidemiologists to elucidate potential etiologies of diseases. Prospective cohort studies can be used to assess natural history or to assess potential disease etiologies. Controlled trials are designed to assess the efficacy of therapeutic interventions. Studies that define the sensitivity and specificity of diagnostic tests can be used to assess the utility of those tests. Economic analyses estimate the costs that particular diseases or therapies will require. Each of these study designs has limitations; with the exception of high-quality randomized trials, none of these study designs can establish a causative relationship between putative etiologic (or therapeutic) factors and disease (outcomes).

Experimental Effects of Acute Exercise on Prospective Memory and False Memory.

PubMed

Green, David; Loprinzi, Paul D

2018-01-01

Research demonstrates that acute exercise can enhance retrospective episodic memory performance. However, limited research has examined the effects of acute exercise on prospective memory, and no studies have examined the effects of exercise on false memory performance. This study examined the potential effects of acute exercise on prospective memory and false memory performance. A between-group randomized controlled trial was employed, with participants (college students; M age  = 20 years) randomized into an exercise group (15-minute acute bout of treadmill walking; N = 25) or a control group (15 minutes of sitting; N = 26). Prospective memory was assessed from two laboratory and two naturalistic assessments outside the lab. False memory was assessed using a word-list trial. There were no statistically significant differences in prospective memory based on group allocation (F Group×Time  = 1.17; P = 0.32; η 2  = 0.06). However, the control group recalled more false words and had a higher rate of false memory recognition (F Group×Time  = 3.15; P = 0.01; η 2  = 0.26). These findings indicate that acute moderate-intensity aerobic exercise is not associated with prospective memory performance but provides some suggestive evidence that acute exercise may reduce the rate of false memories.

DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity (DUTCH PEERS): rationale and study design of a randomized multicenter trial in a Dutch all-comers population.

PubMed

Tandjung, Kenneth; Basalus, Mounir W Z; Sen, Hanim; Jessurun, Gillian A J; Danse, Peter W; Stoel, Martin; Linssen, Gerard C M; Derks, Anita; van Loenhout, Ton T; Nienhuis, Mark B; Hautvast, Raymond W M; von Birgelen, Clemens

2012-04-01

Drug-eluting stents (DES) are increasingly used for the treatment of coronary artery disease. An optimized DES performance is desirable to successfully treat various challenging coronary lesions in a broad population of patients. In response to this demand, third-generation DES with an improved deliverability were developed. Promus Element (Boston Scientific, Natick, MA) and Resolute Integrity (Medtronic Vascular, Santa Rosa, CA) are 2 novel third-generation DES for which limited clinical data are available. Accordingly, we designed the current multicenter study to investigate in an all-comers population whether the clinical outcome is similar after stenting with Promus Element versus Resolute Integrity. DUTCH PEERS is a multicenter, prospective, single-blinded, randomized trial in a Dutch all-comers population. Patients with all clinical syndromes who require percutaneous coronary interventions with DES implantation are eligible. In these patients, the type of DES implanted will be randomized in a 1:1 ratio between Resolute Integrity versus Promus Element. The trial is powered based on a noninferiority hypothesis. For each stent arm, 894 patients will be enrolled, resulting in a total study population of 1,788 patients. The primary end point is the incidence of target vessel failure at 1-year follow-up. DUTCH PEERS is the first randomized multicenter trial with a head-to-head comparison of Promus Element and Resolute Integrity to investigate the safety and efficacy of these third-generation DES. Copyright © 2012 Mosby, Inc. All rights reserved.

Placebo controlled, prospectively randomized, double-blinded study for the investigation of the effectiveness and safety of the acoustic wave therapy (AWT(®)) for cellulite treatment.

PubMed

Russe-Wilflingseder, Katharina; Russe-Wilfingsleder, Katharina; Russe, Elisabeth; Vester, Johannes C; Haller, Gerd; Novak, Pavel; Krotz, Alexander

2013-06-01

Placebo controlled double-blinded, prospectively randomized clinical trial with 17 patients (11 verum, 5 placebo) for evaluation of cellulite treatment with Acoustic Wave Therapy, (AWT(®)) was performed. The patients were treated once a week for 7 weeks, a total of 8 treatments with the D-ACTOR(®) 200 by Storz Medical AG. Data were collected at baseline, before 8th treatment, at 1 month (follow-up 1) and at 3 months (follow-up 2) after the last treatment with a patients' questionnaire, weight control, measurement of circumference and standardized photography. Treatment progress was further documented using a specially designed 3D imaging system (SkinSCAN(3D), 3D-Shape GmbH) providing an objective measure of cellulite (primary efficacy criteria). Patient's questionnaire in the verum group revealed an improvement in number and depth of dimples, skin firmness and texture, in shape and in reduction of circumference. The overall result (of skin waviness, Sq and Sz, surface and volume of depressions and elevations, Vvv and Vmp) at two follow-up visits indicates a more than medium sized superiority (MW = 0.6706) and is statistically significant (pWei-Lachin = 0.0106). The placebo group revealed no statistical significance. No side effects were seen. This indicates the efficacy and safety of AWT(®) for patients with cellulite.

A prospective, randomized, double-blinded single-site control study comparing blood loss prevention of tranexamic acid (TXA) to epsilon aminocaproic acid (EACA) for corrective spinal surgery

PubMed Central

2010-01-01

Background Multilevel spinal fusion surgery has typically been associated with significant blood loss. To limit both the need for transfusions and co-morbidities associated with blood loss, the use of anti-fibrinolytic agents has been proposed. While there is some literature comparing the effectiveness of tranexamic acid (TXA) to epsilon aminocaproic acid (EACA) in cardiac procedures, there is currently no literature directly comparing TXA to EACA in orthopedic surgery. Methods/Design Here we propose a prospective, randomized, double-blinded control study evaluating the effects of TXA, EACA, and placebo for treatment of adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis (NMS), and adult deformity (AD) via corrective spinal surgery. Efficacy will be determined by intraoperative and postoperative blood loss. Other clinical outcomes that will be compared include transfusion rates, preoperative and postoperative hemodynamic values, and length of hospital stay after the procedure. Discussion The primary goal of the study is to determine perioperative blood loss as a measure of the efficacy of TXA, EACA, and placebo. Based on current literature and the mechanism by which the medications act, we hypothesize that TXA will be more effective at reducing blood loss than EACA or placebo and result in improved patient outcomes. Trial Registration ClinicalTrials.gov ID: NCT00958581 PMID:20370916

[Long-term effects of pulsed radiofrequency on the dorsal root ganglion and segmental nerve roots for lumbosacral radicular pain: a prospective controlled randomized trial with nerve root block].

PubMed

Fujii, Hiromi; Kosogabe, Yoshinori; Kajiki, Hideki

2012-08-01

Although pulsed radiofrequency (PRF) method for lumbosacral radicular pain (LSRP) is reportedly effective, there are no prospective controlled trials. We assessed the long-term efficacy of PRF of the dorsal root ganglion and nerve roots for LSRP as compared with nerve root block (RB). The study included 27 patients suffering from LSRP. The design of this study was randomized with a RB control. In the PRF group, the PRF current was applied for 120 seconds after RB. In the RB group, the patients received RB only. Visual analogue scale (VAS) was assessed immediately before, and immediately, 2 hours, 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year after the procedure. P<0.05 was regarded as denoting statistical significance. In both groups, the VAS not only of short-term but also of long-term (6 months and 1 year after procedure) significantly decreased as compared with that before treatment (P<0.05). There were no significant differences of VAS between the two groups at the same time points. This study indicates that PRF adjacent to the dorsal root ganglion and nerve roots for LSRP has long-term effects. There were no significant differences of long-term effects between the two groups.

Rethinking Risk: Prospect Theory Application in Health Message Framing Research.

PubMed

Harrington, Nancy Grant; Kerr, Anna M

2017-02-01

Although prospect theory conceptualizes risk as uncertainty, health message framing research based on the theory typically conceptualizes risk as severity. This study reports the results of two experiments designed to explore these alternative conceptualizations of risk and their effect on health decision making. Participants (N 1  = 768, N 2  = 532) were randomly assigned to one of four conditions that presented a hypothetical scenario of a sexually transmitted disease (STD) outbreak. The conditions were defined by message prompt (deadly vs. easily curable STD) and response option frame (gain vs. loss). Participants selected which of two programs (certain outcome vs. uncertain outcome) they would prefer to combat the outbreak. Across both experiments, participants expressed strong preferences for certain (low risk) outcomes in the gain-framed conditions and no preferences in the loss-framed conditions. These differences held regardless of the consequence severity of the scenario. We discuss the theoretical and practical implications of these results and offer directions for future research.

Project Whitefeather

NASA Astrophysics Data System (ADS)

Four primary tasks have been carried out in this program. Upon request of LANL, the Eloranta paper was reviewed. It was determined that the correlation solution presented was too computationally complex to execute in the allocated 1 second update time. An alternative algorithm approach was under taken using a simulation baseline. A simulation was developed and applied to generate synthetic LIDAR data from randomized aerosol patches drifting with the wind. Algorithms have been designed and implemented in the simulation to reduce the data and apply it to obtain wind estimates. A substantial effort was completed in reverse engineering the EVIEW data format structure of the supplied data. Finally the collected, LIDAR data has been examined to obtain an assessment of the prospects for successful wind estimation. Unfortunately, the data examination has not shown good prospects for a successful outcome. It is recommended that future data be taken with the procedure previously outlined. Hercules believes that if lidar data is collected using this procedure that wind information will be as successful using the collected data as it was in simulation.

A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (APPAC trial).

PubMed

Paajanen, Hannu; Grönroos, Juha M; Rautio, Tero; Nordström, Pia; Aarnio, Markku; Rantanen, Tuomo; Hurme, Saija; Dean, Kirsti; Jartti, Airi; Mecklin, Jukka-Pekka; Sand, Juhani; Salminen, Paulina

2013-02-08

Although the standard treatment of acute appendicitis (AA) consists of an early appendectomy, there has recently been both an interest and an increase in the use of antibiotic therapy as the primary treatment for uncomplicated AA. However, the use of antibiotic therapy in the treatment of uncomplicated AA is still controversial. The APPAC trial is a randomized prospective controlled, open label, non-inferiority multicenter trial designed to compare antibiotic therapy (ertapenem) with emergency appendectomy in the treatment of uncomplicated AA. The primary endpoint of the study is the success of the randomized treatment. In the antibiotic treatment arm successful treatment is defined as being discharged from the hospital without the need for surgical intervention and no recurrent appendicitis during a minimum follow-up of one-year (treatment efficacy). Treatment efficacy in the operative treatment arm is defined as successful appendectomy evaluated to be 100%. Secondary endpoints are post-intervention complications, overall morbidity and mortality, the length of hospital stay and sick leave, treatment costs and pain scores (VAS, visual analoque scale). A maximum of 610 adult patients (aged 18-60 years) with a CT scan confirmed uncomplicated AA will be enrolled from six hospitals and randomized by a closed envelope method in a 1:1 ratio either to undergo emergency appendectomy or to receive ertapenem (1 g per day) for three days continued by oral levofloxacin (500 mg per day) plus metronidazole (1.5 g per day) for seven days. Follow-up by a telephone interview will be at 1 week, 2 months and 1, 3, 5 and 10 years; the primary and secondary endpoints of the trial will be evaluated at each time point. The APPAC trial aims to provide level I evidence to support the hypothesis that approximately 75-85% of patients with uncomplicated AA can be treated with effective antibiotic therapy avoiding unnecessary appendectomies and the related operative morbidity, also resulting in major cost savings.

Chinese herbal medicine (Ma Zi Ren Wan) for functional constipation: study protocol for a prospective, double-blinded, double-dummy, randomized controlled trial

PubMed Central

2013-01-01

Background Functional constipation is a common clinical complaint. Although the effectiveness of Ma Zi Ren Wan for alleviating functional constipation symptoms has been proven in a previous randomized placebo-controlled study, further evidence is needed to make clinical recommendations about Chinese herbal medicine. In particular, a comparison with conventional western medicine for functional constipation patients is needed. Methods/Design This is a prospective, double-blinded, double dummy, randomized, controlled trial. After a 2-week run-in period, eligible patients (Rome III) with excessive traditional Chinese medicine syndrome will randomly be assigned to the Chinese medicine arm (Ma Zi Ren Wan and western medicine placebo), western medicine arm (senna and Chinese medicine placebo) or placebo arm (Chinese medicine placebo and western medicine placebo). Patients will undergo an 8-week treatment and an 8-week follow-up. The primary outcome is the responder rate for complete spontaneous bowel movement (CSBM) during treatment. Patients with a mean increase of CSBM ≧1/week in comparison with their baselines are defined as responders. The secondary outcomes include responder rate during follow-up, changes of colonic transit as measured with radio-opaque markers, individual and global symptom assessments, and reported adverse effects. Discussion This study is the first study to compare a Chinese Herbal Medicine (Ma Zi Ren Wan) with a laxative that is commonly used in the clinical practice of western medicine, and with a placebo. This study will complete the investigation of Ma Zi Ren Wan for functional constipation, and should, therefore, suggest recommendations for clinical practice. Furthermore, the process of first conducting a systematic review, then implementing a dose determination study followed by a placebo-control trial, and finally, comparing traditional Chinese medicine with an active conventional medicine in a controlled trial can be a reference to other researches on Chinese medicine interventions in the future. Trial registration NCT01695850 PMID:24180235

The Efficacy of Vitamin C on Postoperative Outcomes after Posterior Lumbar Interbody Fusion: A Randomized, Placebo-Controlled Trial

PubMed Central

Yang, Han Seok; Yeom, Jin S.; Ahn, Myun-Whan

2017-01-01

Background Vitamin C has critical features relavant to postoperative pain management and functional improvement; however, no study has yet evaluated the effectiveness of vitamin C on improving the surgical outcomes for spine pathologies. Thus, this study aimed to explore the impact of vitamin C on postoperative outcomes after single-level posterior lumbar interbody fusion (PLIF) for lumbar spinal stenosis in prospectively randomized design. We conducted a 1-year prospective, randomized, placebo-controlled, double-blind study to evaluate the impact of vitamin C on the postoperative outcomes after PLIF surgery. Methods A total of 123 eligible patients were randomly assigned to either group A (62 patients with vitamin C) or group B (61 patients with placebo). Patient follow-up was continued for at least 1 year after surgery. The primary outcome measure was pain intensity in the lower back using a visual analogue scale. The secondary outcome measures were: (1) the clinical outcome assessed using the Oswestry Disability Index (ODI); (2) the fusion rate assessed using dynamic radiographs and computed tomography scans; and (3) complications. Results Pain intensity in the lower back was significantly improved in both groups compared with preoperative pain intensity, but no significant difference was observed between the 2 groups over the follow-up period. The ODI score of group A at the third postoperative month was significantly higher than the score of group B. After the sixth postoperative month, the ODI score of group A was slightly higher than the score of group B; however, this difference was not significant. The fusion rates at 1 year after surgery and the complication rates were not significantly different between the 2 groups. Conclusions Postoperative pain intensity, the primary outcome measure, was not significantly different at 1 year after surgery between the 2 groups. However, vitamin C may be associated with improving functional status after PLIF surgery, especially during the first 3 postoperative months. PMID:28861199

Influence on ocular surface after cataract surgery and effect of topical diquafosol on postoperative dry eye: a multicenter prospective randomized study

PubMed Central

Miyake, Kensaku; Yokoi, Norihiko

2017-01-01

Purpose To investigate influences of 3% diquafosol sodium ophthalmic solution (DQS) on ocular surface after cataract surgery and effects on postoperative dry eye. Design This study had two consecutive prospective study phases. The former was an observational study from before cataract surgery to 4 weeks after surgery and the latter was a randomized open-label study from 4 to 8 weeks after surgery. Methods Subjects were 433 eyes of 433 patients undergoing cataract surgery with intraocular lens implantation. Dry eye examination of tear breakup time (BUT), corneal and conjunctival fluorescein staining scores, total subjective symptom score (12 symptoms), and Schirmer I test were conducted before surgery and 4 weeks after surgery. Patient demographics and these examination results were used to analyze risk factors to predict postoperative dry eye. In a randomized study, 154 eyes diagnosed with dry eye postoperatively were applied either DQS or artificial tears (AT) six times daily for 4 weeks. The data of the examinations were compared. Results At 4 weeks after surgery, BUT was shortened significantly (P=0.036), fluorescein staining score increased significantly (P=0.012), but total subjective symptom score was significantly improved (P<0.001). The majority of postoperative dry eye was shortened BUT type (53.1%). The dry eye prevalence after surgery decreased (55.7%) compared with before surgery (69.7%). Females and the patient with dry eye symptoms before surgery had significant risk factors for postoperative dry eye. In a randomized study, BUT was significantly prolonged in the DQS group (P=0.015), but not in the AT group. Fluorescein staining score was significantly improved in both groups (P<0.001). Total subjective symptom score was significantly decreased in the AT group (P<0.001), but not in the DQS group. Conclusion Our study suggests that cataract surgery has harmful effects on tear film stability and ocular surface, and DQS has a capability to improve them. PMID:28360509

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 registration ClinicalTrials.gov NCT01894880 PMID:28231274

The Efficacy of Vitamin C on Postoperative Outcomes after Posterior Lumbar Interbody Fusion: A Randomized, Placebo-Controlled Trial.

PubMed

Lee, Gun Woo; Yang, Han Seok; Yeom, Jin S; Ahn, Myun-Whan

2017-09-01

Vitamin C has critical features relavant to postoperative pain management and functional improvement; however, no study has yet evaluated the effectiveness of vitamin C on improving the surgical outcomes for spine pathologies. Thus, this study aimed to explore the impact of vitamin C on postoperative outcomes after single-level posterior lumbar interbody fusion (PLIF) for lumbar spinal stenosis in prospectively randomized design. We conducted a 1-year prospective, randomized, placebo-controlled, double-blind study to evaluate the impact of vitamin C on the postoperative outcomes after PLIF surgery. A total of 123 eligible patients were randomly assigned to either group A (62 patients with vitamin C) or group B (61 patients with placebo). Patient follow-up was continued for at least 1 year after surgery. The primary outcome measure was pain intensity in the lower back using a visual analogue scale. The secondary outcome measures were: (1) the clinical outcome assessed using the Oswestry Disability Index (ODI); (2) the fusion rate assessed using dynamic radiographs and computed tomography scans; and (3) complications. Pain intensity in the lower back was significantly improved in both groups compared with preoperative pain intensity, but no significant difference was observed between the 2 groups over the follow-up period. The ODI score of group A at the third postoperative month was significantly higher than the score of group B. After the sixth postoperative month, the ODI score of group A was slightly higher than the score of group B; however, this difference was not significant. The fusion rates at 1 year after surgery and the complication rates were not significantly different between the 2 groups. Postoperative pain intensity, the primary outcome measure, was not significantly different at 1 year after surgery between the 2 groups. However, vitamin C may be associated with improving functional status after PLIF surgery, especially during the first 3 postoperative months.

Sickle cell disease and venous thromboembolism in pregnancy and the puerperium.

PubMed

Noubouossie, Denis; Key, Nigel S

2015-02-01

Recent data strongly suggest an increased risk of venous thromboembolism in subjects with sickle cell disease and to a lesser extent, sickle cell trait. However, most studies have been retrospective, case-control or cross-sectional based on data obtained from administrative databases. More data from adequately powered prospective studies that include matched controls are needed to definitely establish the link between venous thromboembolism during pregnancy and sickle hemoglobin disorders. Similarly, there remains a need for properly designed randomized control trials to establish the safety of various hormonal contraceptive methods in women with sickle cell disorders. © 2015 Elsevier Ltd. All rights reserved.

Kids Identifying and Defeating Stroke (KIDS): design of a school-based intervention to improve stroke awareness.

PubMed

Gonzales, Nicole R; Brown, Devin L; Maddox, Katherine E; Conley, Kathleen M; Espinosa, Nina; Pary, Jennifer K; Karim, Asha P; Moyé, Lemuel A; Grotta, James C; Morgenstern, Lewis B

2007-01-01

We describe the design and baseline data of an educational intervention targeting predominantly Mexican American middle school students and their parents in an effort to improve stroke awareness. Increasing awareness in this group may increase the number of patients eligible for acute stroke treatment by encouraging emergency medical services (EMS) activation. This is a prospective, randomized study in which six middle schools were randomly assigned to receive a stroke education program or the standard health class. Primary outcome measures are the percentage of students and parents who recognize stroke symptoms and express the intent to activate EMS upon recognition of these findings. A total of 547 students (271 control, 276 intervention) and 484 parents (231 control, 253 intervention) have been enrolled. Pretests were administered. The intervention has been successfully carried out in the parent and student cohorts over a three-year period. Posttests and persistence test results are pending. Implementing a school-based stroke education initiative is feasible. Followup testing will demonstrate whether this educational initiative translates into a measurable and persistent improvement in stroke knowledge and behavioral intent to activate EMS upon recognition of stroke symptoms.

Study Design and Rationale of "A Multicenter, Open-Labeled, Randomized Controlled Trial Comparing MIdazolam Versus MOrphine in Acute Pulmonary Edema": MIMO Trial.

PubMed

Dominguez-Rodriguez, Alberto; Burillo-Putze, Guillermo; Garcia-Saiz, Maria Del Mar; Aldea-Perona, Ana; Harmand, Magali González-Colaço; Mirò, Oscar; Abreu-Gonzalez, Pedro

2017-04-01

Morphine has been used for several decades in cases of acute pulmonary edema (APE) due to the anxiolytic and vasodilatory properties of the drug. The non-specific depression of the central nervous system is probably the most significant factor for the changes in hemodynamics in APE. Retrospective studies have shown both negative and neutral effects in patients with APE and therefore some authors have suggested benzodiazepines as an alternative treatment. The use of intravenous morphine in the treatment of APE remains controversial. The MIdazolan versus MOrphine in APE trial (MIMO) is a multicenter, prospective, open-label, randomized study designed to evaluate the efficacy and safety of morphine in patients with APE. The MIMO trial will evaluate as a primary endpoint whether intravenous morphine administration improves clinical outcomes defined as in-hospital mortality. Secondary endpoint evaluation will be mechanical ventilation, cardiopulmonary resuscitation, intensive care unit admission rate, intensive care unit length of stay, and hospitalization length. In the emergency department, morphine is still used for APE in spite of poor scientific background data. The data from the MIMO trial will establish the effect-and especially the risk-when using morphine for APE.

The Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial.

PubMed

Eichhorn, Eric J; Bristow, Michael R

2001-01-01

Previous trials (Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure [MERIT-HF], Cardiac Insufficiency Bisoprolol Study [CIBIS] II) have demonstrated a mortality benefit of beta-adrenergic blockade in patients with mild to moderate heart failure. The recent Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial has extended these results to a more advanced patient population. This trial did not, however, include patients who could not reach compensation, patients with far advanced heart failure symptoms, or a significant number of black patients. Future studies of beta-blockade may focus on these patients or patients with asymptomatic left ventricular dysfunction.

The Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial

PubMed Central

Eichhorn, Eric J; Bristow, Michael R

2001-01-01

Previous trials (Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure [MERIT-HF], Cardiac Insufficiency Bisoprolol Study [CIBIS] II) have demonstrated a mortality benefit of β-adrenergic blockade in patients with mild to moderate heart failure. The recent Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial has extended these results to a more advanced patient population. This trial did not, however, include patients who could not reach compensation, patients with far advanced heart failure symptoms, or a significant number of black patients. Future studies of β-blockade may focus on these patients or patients with asymptomatic left ventricular dysfunction. PMID:11806769

A systematic review of hypofractionation for primary management of prostate cancer.

PubMed

Koontz, Bridget F; Bossi, Alberto; Cozzarini, Cesare; Wiegel, Thomas; D'Amico, Anthony

2015-10-01

Technological advances in radiation therapy delivery have permitted the use of high-dose-per-fraction radiation therapy (RT) for early-stage prostate cancer (PCa). Level 1 evidence supporting the safety and efficacy of hypofractionated RT is evolving as this modality becomes more widely utilized and refined. To perform a systematic review of the current evidence on the safety and efficacy of hypofractionated RT for early-stage PCa and to provide in-context recommendations for current application of this technology. Embase, PubMed, and Scopus electronic databases were queried for English-language articles from January 1990 through June 2014. Prospective studies with a minimum of 50 patients were included. Separate consideration was made for studies involving moderate hypofractionation (doses of 2.5-4Gy per fraction) and extreme hypofractionation (5-10Gy in 4-7 fractions). Six relatively small superiority designed randomized trials of standard fractionation versus moderate hypofractionation in predominantly low- and intermediate-risk PCa have been published with follow-up ranging from 4 to 8 yr, noting similar biochemical control (5-yr freedom from biochemical failure in modern studies is >80% for low-risk and intermediate-risk patients) and late grade ≥2 genitourinary and gastrointestinal toxicities (between 2% and 20%). Noninferiority studies are pending. In prospective phase 2 studies, extreme hypofractionation has promising 2- to 5-yr biochemical control rates of >90% for low-risk patients. Results from a randomized trial are expected in 2015. Moderate hypofractionation has 5-yr data to date establishing safety compared with standard fractionation, but 10-yr outcomes and longer follow-up are needed to establish noninferiority for clinical effectiveness. Extreme hypofractionation is promising but as yet requires reporting of randomized data prior to application outside of a clinical protocol. Hypofractionation for prostate cancer delivers relatively high doses of radiation per treatment. Prospective studies support the safety of moderate hypofractionation, while extreme fractionation may have greater toxicity. Both show promising cancer control but long-term results of noninferiority studies of both methods are required before use in routine treatment outside of clinical protocols. Copyright © 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.

DIABETES, DEPRESSION, AND DEATH: A RANDOMIZED CONTROLLED TRIAL OF A DEPRESSION TREATMENT PROGRAM FOR OLDER ADULTS BASED IN PRIMARY CARE (PROSPECT)

PubMed Central

Bogner, Hillary R; Morales, Knashawn H; Post, Edward P; Bruce, Martha L

2009-01-01

OBJECTIVE Our a priori hypothesis was that depressed patients with diabetes in practices implementing a depression management program would have a decreased risk of mortality compared to depressed patients with diabetes in usual care practices. RESEARCH DESIGN AND METHODS Multi-site practice-randomized controlled trial PROSPECT (Prevention of Suicide in Primary Care Elderly: Collaborative Trial) with patient recruitment from 5/99-8/01 and supplemented with a search of the National Death Index. Twenty primary care practices participated from New York City, Philadelphia, and Pittsburgh. In all, 584 participants who were identified though a two-stage, age-stratified (60-74; 75+) depression screening of randomly sampled patients and were classified as depressed with complete information on diabetes status are included in these analyses. Of all the 584 participants, 123 (21.2%) reported a history of diabetes. A depression care manager worked with primary care physicians to provide algorithm-based care. Vital status was assessed at 5 years. RESULTS After a median follow-up of 52.0 months, 110 depressed patients had died. Depressed patients with diabetes in the Intervention Condition were less likely to have died during the 5-year follow-up interval than were depressed persons with diabetes in Usual Care after accounting for baseline differences among patients (adjusted hazard ratio 0.49, 95% CI [0.24, 0.98]). CONCLUSIONS Older depressed primary care patients with diabetes in practices implementing depression care management were less likely to die over the course of a 5-year interval than were depressed patients with diabetes in usual care practices. PMID:17717284

Rationale, Design, and Baseline Characteristics of the Utopia Trial for Preventing Diabetic Atherosclerosis Using an SGLT2 Inhibitor: A Prospective, Randomized, Open-Label, Parallel-Group Comparative Study.

PubMed

Katakami, Naoto; Mita, Tomoya; Yoshii, Hidenori; Shiraiwa, Toshihiko; Yasuda, Tetsuyuki; Okada, Yosuke; Umayahara, Yutaka; Kaneto, Hideaki; Osonoi, Takeshi; Yamamoto, Tsunehiko; Kuribayashi, Nobuichi; Maeda, Kazuhisa; Yokoyama, Hiroki; Kosugi, Keisuke; Ohtoshi, Kentaro; Hayashi, Isao; Sumitani, Satoru; Tsugawa, Mamiko; Ohashi, Makoto; Taki, Hideki; Nakamura, Tadashi; Kawashima, Satoshi; Sato, Yasunori; Watada, Hirotaka; Shimomura, Iichiro

2017-10-01

Sodium-glucose co-transporter-2 (SGLT2) inhibitors are anti-diabetic agents that improve glycemic control with a low risk of hypoglycemia and ameliorate a variety of cardiovascular risk factors. The aim of the ongoing study described herein is to investigate the preventive effects of tofogliflozin, a potent and selective SGLT2 inhibitor, on the progression of atherosclerosis in subjects with type 2 diabetes (T2DM) using carotid intima-media thickness (IMT), an established marker of cardiovascular disease (CVD), as a marker. The Study of Using Tofogliflozin for Possible better Intervention against Atherosclerosis for type 2 diabetes patients (UTOPIA) trial is a prospective, randomized, open-label, blinded-endpoint, multicenter, and parallel-group comparative study. The aim was to recruit a total of 340 subjects with T2DM but no history of apparent CVD at 24 clinical sites and randomly allocate these to a tofogliflozin treatment group or a conventional treatment group using drugs other than SGLT2 inhibitors. As primary outcomes, changes in mean and maximum IMT of the common carotid artery during a 104-week treatment period will be measured by carotid echography. Secondary outcomes include changes in glycemic control, parameters related to β-cell function and diabetic nephropathy, the occurrence of CVD and adverse events, and biochemical measurements reflecting vascular function. This is the first study to address the effects of SGLT2 inhibitors on the progression of carotid IMT in subjects with T2DM without a history of CVD. The results will be available in the very near future, and these findings are expected to provide clinical data that will be helpful in the prevention of diabetic atherosclerosis and subsequent CVD. Kowa Co., Ltd. UMIN000017607.

Frequency of Hand Decontamination of Intraoperative Providers and Reduction of Postoperative Healthcare-Associated Infections: A Randomized Clinical Trial of a Novel Hand Hygiene System.

PubMed

Koff, Matthew D; Brown, Jeremiah R; Marshall, Emily J; O'Malley, A James; Jensen, Jens T; Heard, Stephen O; Longtine, Karen; O'Neill, Melissa; Longtine, Jaclyn; Houston, Donna; Robison, Cindy; Moulton, Eric; Patel, Hetal M; Loftus, Randy W

2016-08-01

BACKGROUND Healthcare provider hands are an important source of intraoperative bacterial transmission events associated with postoperative infection development. OBJECTIVE To explore the efficacy of a novel hand hygiene improvement system leveraging provider proximity and individual and group performance feedback in reducing 30-day postoperative healthcare-associated infections via increased provider hourly hand decontamination events. DESIGN Randomized, prospective study. SETTING Dartmouth-Hitchcock Medical Center in New Hampshire and UMass Memorial Medical Center in Massachusetts. PATIENTS Patients undergoing surgery. METHODS Operating room environments were randomly assigned to usual intraoperative hand hygiene or to a personalized, body-worn hand hygiene system. Anesthesia and circulating nurse provider hourly hand decontamination events were continuously monitored and reported. All patients were followed prospectively for the development of 30-day postoperative healthcare-associated infections. RESULTS A total of 3,256 operating room environments and patients (1,620 control and 1,636 treatment) were enrolled. The mean (SD) provider hand decontamination event rate achieved was 4.3 (2.9) events per hour, an approximate 8-fold increase in hand decontamination events above that of conventional wall-mounted devices (0.57 events/hour); P<.001. Use of the hand hygiene system was not associated with a reduction in healthcare-associated infections (odds ratio, 1.07 [95% CI, 0.82-1.40], P=.626). CONCLUSIONS The hand hygiene system evaluated in this study increased the frequency of hand decontamination events without reducing 30-day postoperative healthcare-associated infections. Future work is indicated to optimize the efficacy of this hand hygiene improvement strategy. Infect Control Hosp Epidemiol 2016;37:888-895.

Central venous access by trainees: a systematic review and meta-analysis of the use of simulation to improve success rate on patients.

PubMed

Madenci, Arin L; Solis, Carolina V; de Moya, Marc A

2014-02-01

Simulation training for invasive procedures may improve patient safety by enabling efficient training. This study is a meta-analysis with rigorous inclusion and exclusion criteria designed to assess the real patient procedural success of simulation training for central venous access. Published randomized controlled trials and prospective 2-group cohort studies that used simulation for the training of procedures involving central venous access were identified. The quality of each study was assessed. The primary outcome was the proportion of trainees who demonstrated the ability to successfully complete the procedure. Secondary outcomes included the mean number of attempts to procedural success and periprocedural adverse events. Proportions were compared between groups using risk ratios (RRs), whereas continuous variables were compared using weighted mean differences. Random-effects analysis was used to determine pooled effect sizes. We identified 550 studies, of which 5 (3 randomized controlled trials, 2 prospective 2-group cohort studies) studies of central venous catheter (CVC) insertion were included in the meta-analysis, composed of 407 medical trainees. The simulation group had a significantly larger proportion of trainees who successfully placed CVCs (RR, 1.09; 95% confidence interval [CI], 1.03-1.16, P<0.01). In addition, the simulation group had significantly fewer mean attempts to CVC insertion (weighted mean difference, -1.42; 95% CI, -2.34 to -0.49, P<0.01). There was no significant difference in the rate of adverse events between the groups (RR, 0.50; 95% CI, 0.19-1.29; P=0.15). Training programs should consider adopting simulation training for CVC insertion to improve the real patient procedural success of trainees.

A prospective, randomized study of the patency period of the plastic antireflux biliary stent: an interim analysis.

PubMed

Leong, Quan Wai; Shen, Mira L; Au, Kim W; Luo, Derek; Lau, James Y; Wu, Justin C; Chan, Francis K; Sung, Joseph J

2016-02-01

There is as yet no ideal design of a plastic biliary stent with the longest patency period. To study the safety and effective patency period of a new plastic antireflux biliary stent in the clinical setting. We conducted a prospective, randomized trial to compare the patency of 2 similar plastic biliary stents, one of which has an antiduodenobiliary reflux property. The study was conducted at 2 separate tertiary centers in 2 countries. Patients with inoperable distal malignant biliary obstruction were recruited. One of the 2 types of plastic stents under study was randomly chosen and inserted in the common bile duct of the study subjects. The subjects were followed until the end of study or occlusion occurrence. Our primary endpoint was the time to stent occlusion in days, with stent-related adverse events and all-cause mortality the secondary endpoints. A total of 16 subjects were recruited for the study; 7 were allocated to group A (ordinary Tannenbaum stent) and 9 to group B (antireflux biliary stent). Five of 7 subjects (71%) in group B had stent occlusion within 8 days, and the primary end point was reached in all 7 subjects within 30 days, whereas the primary endpoint was not reached within 30 days in any of the subjects in group A. Our data showed a significantly shorter stent patency period in group B compared with group A (P < .003). Small sample size. Routine use of antireflux plastic biliary stents in the palliative management of malignant biliary obstructions cannot be recommended at present. (Clinical trial registration number: NCT01142921.). Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Electrosurgery reduces blood loss and immediate postoperative inflammation compared to cold instruments for midline celiotomy in dogs: A randomized controlled trial

PubMed Central

Meakin, Lee B.; Murrell, Jo C.; Doran, Ivan C. P.; Knowles, Toby G.; Tivers, Michael S.

2017-01-01

Abstract Objectives To compare the use of an electrosurgical device with traditional cold instruments (scalpel and scissors) for midline celiotomy incision. Study design Prospective randomized controlled clinical trial. Sample population: One hundred and twenty client‐owned dogs undergoing abdominal surgery. Methods Dogs were prospectively recruited and randomized to receive electroincision or cold instrument incision. For cold incision, surgeons used basic surgical instruments including scalpel and scissors. For electroincision, surgeons only used the electrosurgical device in cutting mode. Time for the approach, blood loss, and the incision length were recorded. A blinded observer assessed pain and incision redness, swelling, and discharge at 24 and 48 hours postoperative (graded 0‐3). Owner assessment of incision healing was recorded by telephone interview. Results Blood loss during surgery was significantly lower for electroincision (mean 0.7, SD 1.7 mL) than cold incision (mean 3.0, SD 4.3 mL, P < .0001) with no significant difference in incision length or time for approach. Electroincision was associated with significantly less incision redness (cold median 1, range 0‐3; electroincision median 0, range 0‐2, P = .02) and less incision discharge (cold median 0.5 range 0‐3; electroincision median 0, range 0‐1, P = .006) at 24 hours postoperative. There was no significant difference in pain scores or incision healing in dogs receiving the two techniques. No incisional hernias were reported. A surgical site infection occurred in 1 dog (cold incision). Conclusions Electroincision for a celiotomy approach in the dog reduces blood loss, and incision redness and discharge in the immediate postoperative period without affecting the occurrence of wound complications such as infection and dehiscence (including linea alba). PMID:28314089

[A prospective, randomized, double-blinded control study on comparison of tramadol, clonidine and dexmedetomidine for post spinal anesthesia shivering].

PubMed

Venkatraman, Rajagopalan; Karthik, Krishnamoorthy; Pushparani, Anand; Mahalakshmi, Annadurai

Shivering, a common intraoperative problem under spinal anesthesia increases the oxygen consumption considerably and is uncomfortable and distressing to the patient, anesthesiologist as well as surgeon. The present study was designed to explore the effectiveness of tramadol, clonidine and dexmedetomidine in the treatment of post spinal anesthesia shivering and to look for their adverse effects. This prospective, randomized, double blinded control study was done on 90 patients who developed shivering under spinal anesthesia. They were randomly allocated into three groups with Group T receiving tramadol 1mg.kg -1 , Group C getting clonidine 1mcg.kg -1 and Group D patients receiving dexmedetomidine 0.5mcg.kg -1 . The time taken to control shivering, recurrence rate, hemodynamic variables, sedation score and adverse effects were observed. Dexmedetomidine was faster in the control of shivering in 5.7±0.79minutes (min) whereas tramadol took 6.76±0.93min and clonidine was slower with 9.43±0.93min. The recurrence rate was much lower in the dexmedetomidine group with 3.3% than for clonidine (10%) and tramadol (23.3%) group. The sedation achieved with dexmedetomidine was better than clonidine and tramadol. The tramadol group had more cases of vomiting (four) and dexmedetomidine group had six cases of hypotension and two cases of bradycardia. Two of the clonidine patients encountered bradycardia and hypotension. Dexmedetomidine is better than tramadol and clonidine in the control of shivering because of its faster onset and less recurrence rate. Though complications are encountered in the dexmedetomidine group, they are treatable. Copyright © 2016 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

Umbilical cord mesenchyme stem cell local intramuscular injection for treatment of uterine niche: Protocol for a prospective, randomized, double-blinded, placebo-controlled clinical trial.

PubMed

Fan, Dazhi; Wu, Shuzhen; Ye, Shaoxin; Wang, Wen; Guo, Xiaoling; Liu, Zhengping

2017-11-01

Uterine niche is defined as a triangular anechoic structure at the site of the scar or a gap in the myometrium at the site of a previous caesarean section. The main clinical manifestations are postmenstrual spotting and intrauterine infection, which may seriously affect the daily life of nonpregnant women. Trials have shown an excellent safety and efficacy for the potential of mesenchymal stem cells (MSCs) as a therapeutic option for scar reconstruction. Therefore, this study is designed to investigate the safety and efficacy of using MSCs in the treatment for the uterine niche. This phase II clinical trial is a single-center, prospective, randomized, double-blind, placebo-controlled with 2 arms. One hundred twenty primiparous participants will be randomly (1:1 ratio) assigned to receive direct intramuscular injection of MSCs (a dose of 1*10 cells in 1 mL of 0.9% saline) (MSCs group) or an identical-appearing 1 mL of 0.9% saline (placebo-controlled group) near the uterine incision. The primary outcome of this trial is to evaluate the proportion of participants at 6 months who is found uterine niche in the uterus by transvaginal utrasonography. Adverse events will be documented in a case report form. The study will be conducted at the Department of Obstetric of Southern Medical University Affiliated Maternal & Child Health Hospital of Foshan. This trial is the first investigation of the potential for therapeutic use of MSCs for the management of uterine niche after cesarean delivery. This protocol will help to determine the efficacy and safety of MSCs treatment in uterine niche and bridge the gap with regards to the current preclinical and clinical evidence. NCT02968459 (Clinical Trials.gov: http://clinicaltrials.gov/).

Evaluation of a 30-gene paclitaxel, fluorouracil, doxorubicin and cyclophosphamide chemotherapy response predictor in a multicenter randomized trial in breast cancer

PubMed Central

Tabchy, Adel; Valero, Vicente; Vidaurre, Tatiana; Lluch, Ana; Gomez, Henry; Martin, Miguel; Qi, Yuan; Barajas-Figueroa, Luis Javier; Souchon, Eduardo; Coutant, Charles; Doimi, Franco D; Ibrahim, Nuhad K; Gong, Yun; Hortobagyi, Gabriel N; Hess, Kenneth R; Symmans, W Fraser; Pusztai, Lajos

2010-01-01

Purpose We examined in a prospective, randomized, international clinical trial the performance of a previously defined 30-gene predictor (DLDA-30) of pathologic complete response (pCR) to preoperative weekly paclitaxel and fluorouracil, doxorubicin, cyclophosphamide (T/FAC) chemotherapy, and assessed if DLDA-30 also predicts increased sensitivity to FAC-only chemotherapy. We compared the pCR rates after T/FAC versus FAC×6 preoperative chemotherapy. We also performed an exploratory analysis to identify novel candidate genes that differentially predict response in the two treatment arms. Experimental Design 273 patients were randomly assigned to receive either weekly paclitaxel × 12 followed by FAC × 4 (T/FAC, n=138), or FAC × 6 (n=135) neoadjuvant chemotherapy. All patients underwent a pretreatment FNA biopsy of the tumor for gene expression profiling and treatment response prediction. Results The pCR rates were 19% and 9% in the T/FAC and FAC arms, respectively (p<0.05). In the T/FAC arm, the positive predictive value (PPV) of the genomic predictor was 38% (95%CI:21–56%), the negative predictive value (NPV) 88% (CI:77–95%) and the AUC 0.711. In the FAC arm, the PPV was 9% (CI:1–29%) and the AUC 0.584. This suggests that the genomic predictor may have regimen-specificity. Its performance was similar to a clinical variable-based predictor nomogram. Conclusions Gene expression profiling for prospective response prediction was feasible in this international trial. The 30-gene predictor can identify patients with greater than average sensitivity to T/FAC chemotherapy. However, it captured molecular equivalents of clinical phenotype. Next generation predictive markers will need to be developed separately for different molecular subsets of breast cancers. PMID:20829329

Effects on agitation with rivastigmine patch monotherapy and combination therapy with memantine in mild to moderate Alzheimer's disease: a multicenter 24-week prospective randomized open-label study (the Korean EXelon Patch and combination with mEmantine Comparative Trial study).

PubMed

Yoon, Soo J; Choi, Seong H; Na, Hae R; Park, Kyung-Won; Kim, Eun-Joo; Han, Hyun J; Lee, Jae-Hong; Shim, Young S; Na, Duk L

2017-03-01

Memantine is known to be effective in the treatment of the behavioral symptoms of dementia, especially agitation in moderate to severe Alzheimer's disease (AD). However, memantine and rivastigmine patch combination therapy has not been well studied in determining treatment effectiveness with mild to moderate AD patients. This was a multicenter, 24-week, prospective, randomized, open-label study design. A total 147 AD patients with Mini-Mental State Examination scores from 10 to 20 were randomly assigned to rivastigmine patch monotherapy and combination therapy with memantine groups. Agitation symptoms, using the Korean Version of the Cohen Mansfield Agitation Inventory were evaluated at baseline and at study end. Suppression and emergence of agitation symptoms were also evaluated. We carried out factor analyses to evaluate the interrelationship of agitation symptoms and to investigate treatment response in these symptoms. Factor analyses showed two symptom clusters: factor A - aggressive agitated behaviors - versus factor B - non-aggressive agitated behaviors. The rivastigmine patch monotherapy group showed significantly decreased factor B scores and had a tendency of decreased Korean Version of the Cohen Mansfield Agitation Inventory total scores and factor A scores. Conversely, the combination therapy group showed significantly increased Korean Version of the Cohen Mansfield Agitation Inventory total scores and factor B scores. Neither monotherapy nor combination therapy reduced the emergence of new agitation symptoms. In this trial of mild to moderate AD patients, the rivastigmine patch monotherapy group experienced a reduction of non-aggressive agitated behaviors. However, combination therapy with memantine did not show any benefit on the agitation associated with mild to moderate AD. Geriatr Gerontol Int 2017; 17: 494-499. © 2016 Japan Geriatrics Society.

A random urine test can identify patients at risk of mesalamine non-adherence: a prospective study.

PubMed

Gifford, Anne E; Berg, Anders H; Lahiff, Conor; Cheifetz, Adam S; Horowitz, Gary; Moss, Alan C

2013-02-01

Mesalamine non-adherence is common among patients with ulcerative colitis (UC), and can be difficult to identify in practice. We sought to determine whether a random urine test for salicylates could be used as a marker of 5-aminosalicylic acid (5-ASA) ingestion and identify patients at risk of non-adherence. Our aim is to determine whether measurement of salicylates in a random urine sample correlates with 5-ASA levels, and predicts an individual's risk of mesalamine non-adherence. Prospective observational study. Urinary salicylates (by colorimetry) and 5-ASA (by liquid chromatography and tandem-mass spectrometry) were measured in a random urine sample at baseline in patients and controls. Mesalamine adherence was quantified by patient self-reports at enrollment and pharmacy refills of mesalamine over 6 months. A total of 93 patients with UC taking mesalamine maintenance therapy were prospectively enrolled from the clinic. Random urine salicylate levels (by colorimetry) were highly correlated with urine 5-ASA metabolite levels (by mass spectrometry; R2=0.9). A random urine salicylate level above 15 mg/dl distinguished patients who had recently taken mesalamine from controls (area under the curve value 0.9, sensitivity 95%, specificity 77%). A significant proportion of patients (27%) who self-identified as "high adherers" by an adherence questionnaire (Morisky Medication Adherence Scale-8) had random levels of urine salicylate below this threshold. These patients were at higher risk of objectively measured non-adherence to mesalamine over the subsequent 6 months (RR: 2.7, 95% CI: 1.1-7.0). A random urine salicylate level measured in the clinic can identify patients who have not recently taken mesalamine, and who are at higher risk of longitudinal non-adherence. This test could be used to screen patients who may warrant interventions to improve adherence and prevent disease relapse.

A prospective, 1-year trial using saw palmetto versus finasteride in the treatment of category III prostatitis/chronic pelvic pain syndrome.

PubMed

Kaplan, Steven A; Volpe, Michael A; Te, Alexis E

2004-01-01

This study was designed to assess the safety and efficacy of saw palmetto or finasteride in men with category III prostatitis/chronic pelvic pain syndrome (CP/CPPS). A prospective, randomized, open label, 1-year study was designed to assess the safety and efficacy of saw palmetto and finasteride in the treatment of men diagnosed with CP/CPPS. Patients were randomized to finasteride (5 mg once daily) or saw palmetto (325 mg daily) for 1 year. Patients were evaluated using the National Institutes of Health Chronic Prostatitis Symptom Index, individual domains (pain, urinary symptoms, quality of life and mean pain score) and the American Urological Association Symptom Score at baseline, 3, 6 and 12 months. A total of 64 consecutive men 24 to 58 years old (mean age 43.2) with a diagnosis of CP/CPPS were equally randomized to the 2 treatment arms. All 64 men had previously received antibiotics (duration of 3 to 93 weeks), 52 (82%) had been on alpha-blockade. There were 61, 57 and 56 patients evaluable at 3, 6 and 12 months, respectively. At 1 year mean total National Institutes of Health Chronic Prostatitis Symptom Index score decreased from 23.9 to 18.1 in the finasteride group (p <0.003), and from 24.7 to 24.6 in the saw palmetto arm (p = 0.41). In the finasteride arm the quality of life and pain domains were significantly improved at 1 year; however, urination was not. Adverse events included headache (3 cases) in the saw palmetto group and decreased libido (2 cases) in the finasteride group. At the end of the trial 13 of 32 (41%) and 21 of 32 (66%) opted to continue saw palmetto and finasteride, respectively. CP/CPPS treated with saw palmetto had no appreciable long-term improvement. In contrast, patients treated with finasteride had significant and durable improvement in all various parameters except voiding. Further studies are warranted to ascertain the mechanism and reproducibility of these effects in a placebo controlled trial.

Qualitative Analysis of Student Perceptions Comparing Team-based Learning and Traditional Lecture in a Pharmacotherapeutics Course.

PubMed

Remington, Tami L; Bleske, Barry E; Bartholomew, Tracy; Dorsch, Michael P; Guthrie, Sally K; Klein, Kristin C; Tingen, Jeffrey M; Wells, Trisha D

2017-04-01

Objective. To qualitatively compare students' attitudes and perceptions regarding team-based learning (TBL) and lecture. Design. Students were exposed to TBL and lecture in an elective pharmacotherapeutics course in a randomized, prospective, cross-over design. After completing the course, students provided their attitudes and perceptions through a written self-reflection and narrative questions on the end-of-course evaluation. Student responses were reviewed using a grounded theory coding method. Assessment. Students' responses yielded five major themes: impact of TBL on learning, perceptions about TBL learning methods, changes in approaches to learning, building skills for professional practice, and enduring challenges. Overall, students report TBL enhances their learning of course content (knowledge and application), teamwork skills, and lifelong learning skills. Conclusion. Students' attitudes and perceptions support TBL as a viable pedagogy for teaching pharmacotherapeutics.

Qualitative Analysis of Student Perceptions Comparing Team-based Learning and Traditional Lecture in a Pharmacotherapeutics Course

PubMed Central

Bleske, Barry E.; Bartholomew, Tracy; Dorsch, Michael P.; Guthrie, Sally K.; Klein, Kristin C.; Tingen, Jeffrey M.; Wells, Trisha D.

2017-01-01

Objective. To qualitatively compare students’ attitudes and perceptions regarding team-based learning (TBL) and lecture. Design. Students were exposed to TBL and lecture in an elective pharmacotherapeutics course in a randomized, prospective, cross-over design. After completing the course, students provided their attitudes and perceptions through a written self-reflection and narrative questions on the end-of-course evaluation. Student responses were reviewed using a grounded theory coding method. Assessment. Students’ responses yielded five major themes: impact of TBL on learning, perceptions about TBL learning methods, changes in approaches to learning, building skills for professional practice, and enduring challenges. Overall, students report TBL enhances their learning of course content (knowledge and application), teamwork skills, and lifelong learning skills. Conclusion. Students’ attitudes and perceptions support TBL as a viable pedagogy for teaching pharmacotherapeutics. PMID:28496275

Summary Time Oriented Record (STOR)—A Progress Report

PubMed Central

Simborg, Donald W.; Whiting-O'Keefe, Quinn E.

1981-01-01

A Summary Time Oriented Medical Record System (STOR) has been designed as a potential replacement for the medical record for use in ambulatory care. As described at the Fourth Annual Symposium, this system has unique characteristics aimed specifically for management of patients with chronic diseases. It is hypothesized that this record design will improve information flow to practitioners at the time of decision-making in ambulatory care, while at the same time reducing manual recording requirements by the practitioner. This system has now been implemented in three specialty clinics at the University of California, San Francisco Medical Center. Rigorous evaluation techniques using prospective randomized control studies are being used in its evaluation. The clinical information includes patient problems, diagnoses, therapies, and ancillary test results. It is implemented on an IBM 4331 computer using the RAMIS data base management system.

Association between Adult Height and Risk of Colorectal, Lung, and Prostate Cancer: Results from Meta-analyses of Prospective Studies and Mendelian Randomization Analyses.

PubMed

Khankari, Nikhil K; Shu, Xiao-Ou; Wen, Wanqing; Kraft, Peter; Lindström, Sara; Peters, Ulrike; Schildkraut, Joellen; Schumacher, Fredrick; Bofetta, Paolo; Risch, Angela; Bickeböller, Heike; Amos, Christopher I; Easton, Douglas; Eeles, Rosalind A; Gruber, Stephen B; Haiman, Christopher A; Hunter, David J; Chanock, Stephen J; Pierce, Brandon L; Zheng, Wei

2016-09-01

Observational studies examining associations between adult height and risk of colorectal, prostate, and lung cancers have generated mixed results. We conducted meta-analyses using data from prospective cohort studies and further carried out Mendelian randomization analyses, using height-associated genetic variants identified in a genome-wide association study (GWAS), to evaluate the association of adult height with these cancers. A systematic review of prospective studies was conducted using the PubMed, Embase, and Web of Science databases. Using meta-analyses, results obtained from 62 studies were summarized for the association of a 10-cm increase in height with cancer risk. Mendelian randomization analyses were conducted using summary statistics obtained for 423 genetic variants identified from a recent GWAS of adult height and from a cancer genetics consortium study of multiple cancers that included 47,800 cases and 81,353 controls. For a 10-cm increase in height, the summary relative risks derived from the meta-analyses of prospective studies were 1.12 (95% CI 1.10, 1.15), 1.07 (95% CI 1.05, 1.10), and 1.06 (95% CI 1.02, 1.11) for colorectal, prostate, and lung cancers, respectively. Mendelian randomization analyses showed increased risks of colorectal (odds ratio [OR] = 1.58, 95% CI 1.14, 2.18) and lung cancer (OR = 1.10, 95% CI 1.00, 1.22) associated with each 10-cm increase in genetically predicted height. No association was observed for prostate cancer (OR = 1.03, 95% CI 0.92, 1.15). Our meta-analysis was limited to published studies. The sample size for the Mendelian randomization analysis of colorectal cancer was relatively small, thus affecting the precision of the point estimate. Our study provides evidence for a potential causal association of adult height with the risk of colorectal and lung cancers and suggests that certain genetic factors and biological pathways affecting adult height may also affect the risk of these cancers.

Depression and anxiety predict health-related quality of life in chronic obstructive pulmonary disease: systematic review and meta-analysis.

PubMed

Blakemore, Amy; Dickens, Chris; Guthrie, Else; Bower, Peter; Kontopantelis, Evangelos; Afzal, Cara; Coventry, Peter A

2014-01-01

The causal association between depression, anxiety, and health-related quality of life (HRQoL) in chronic obstructive pulmonary disease (COPD) is unclear. We therefore conducted a systematic review of prospective cohort studies that measured depression, anxiety, and HRQoL in COPD. Electronic databases (Medline, Embase, Cumulative Index to Nursing and Allied Health Literature [CINAHL], British Nursing Index and Archive, PsycINFO and Cochrane database) were searched from inception to June 18, 2013. Studies were eligible for inclusion if they: used a nonexperimental prospective cohort design; included patients with a diagnosis of COPD confirmed by spirometry; and used validated measures of depression, anxiety, and HRQoL. Data were extracted and pooled using random effects models. Six studies were included in the systematic review; of these, three were included in the meta-analysis for depression and two were included for the meta-analysis for anxiety. Depression was significantly correlated with HRQoL at 1-year follow-up (pooled r=0.48, 95% confidence interval 0.37-0.57, P<0.001). Anxiety was also significantly correlated with HRQoL at 1-year follow-up (pooled r=0.36, 95% confidence interval 0.23-0.48, P<0.001). Anxiety and depression predict HRQoL in COPD. However, this longitudinal analysis does not show cause and effect relationships between depression and anxiety and future HRQoL. Future studies should identify psychological predictors of poor HRQoL in well designed prospective cohorts with a view to isolating the mediating role played by anxiety disorder and depression.

Evaluating the use of fibrin glue for sealing low-output enterocutaneous fistulas: study protocol for a randomized controlled trial.

PubMed

Wu, Xiuwen; Ren, Jianan; Wang, Gefei; Wang, Jianzhong; Wang, Feng; Fan, Yueping; Li, Yuanxin; Han, Gang; Zhou, Yanbing; Song, Xiaofei; Quan, Bin; Yao, Min; Li, Jieshou

2015-10-07

The management of an enterocutaneous fistula poses a significant challenge to surgeons and is often associated with a costly hospital stay and long-term discomfort. The use of fibrin glue in the fistula tract has been shown to promote closure of low output enterocutaneous fistulas. Our previous nonrandomized study demonstrated that autologous platelet-rich fibrin glue treatment significantly decreased time to fistula closure and promoted closure rates. However, there are several limitations in the study, which may lead to bias in our conclusion. Thus, a multicenter, randomized, controlled clinical trial is required. The study is designed as a randomized, open-label, three-arm, multicenter study in nine Chinese academic hospitals for evaluating the efficacy and safety of fibrin glue for sealing low-output fistulas. An established number of 171 fistula patients will undergo prospective random assignment to autologous fibrin glue, commercial porcine fibrin sealants or drainage cessation (1:1:1). The primary endpoint is fistula closure time (defined as the interval between the day of enrollment and day of fistula closure) during the 14-day treatment period. To our knowledge, this is the first study to evaluate the safety and efficacy of both autologous and commercial fibrin glue sealing for patients with low-output volume fistulas. NCT01828892 . Registration date: April 2013.

Influence of needle bevel design on injection pain and needle deformation in dental local infiltration anaesthesia - randomized clinical trial.

PubMed

Dau, M; Buttchereit, I; Ganz, C; Frerich, B; Anisimova, E N; Daubländer, M; Kämmerer, P W

2017-11-01

The aims of this in vivo study were to evaluate the impact of needle bevel design on patients' pain perception and the mechanical deformation of the needle tip after the injection. In a prospective single-blinded trial, 150 patients received conventional infiltration anaesthesia for dental treatment by one examiner. Patients were randomized for one out of three different needle bevel types (scalpel-designed bevel needle (SB), n=50; triple bevel needle (TB), n=50; regular bevel needle (RB), n=50). Subjects' self-reported injection pain perception was evaluated using a numeric rating scale (NRS). For each needle tip, deformations after single use were measured using SEM. A significant lower injection pain level was found in SB (mean 2.1±1.2) than in TB (mean 3.5±1.6;) and RB (mean 3.4±1.0; all P<0.001). A needle deformation was detected in about 97.3% of all needles (SB 50/50, TB 50/50, and RB: 46/50). A higher number of barbs were found in SB (29/50) versus TB (17/50) and RB (19/50). For dental local infiltration anaesthesia, injection needles with a scalpel-designed bevel demonstrated significantly less injection pain. Needle tip deflections after anaesthetic agent infiltration, especially barbed hooks on the non-cutting edge may result in greater soft tissue trauma. Copyright © 2017 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Prospective randomized study of chevron osteotomy versus Mitchell's osteotomy in hallux valgus.

PubMed

Buciuto, Robert

2014-12-01

We conducted a prospective randomized trial to compare the most popular osteotomy types of operative treatment of hallux valgus (HV) used in Norway, Mitchell's osteotomy (MO) and chevron osteotomy (CO). One hundred twenty adult female patients were prospectively randomized to treatment with either MO or CO. All operative procedures were performed with ankle block and with tourniquet applied. None of the patients received any antibiotic or antithrombotic prophylaxis. The follow-up period was 3 years. Clinical results were rated according to the American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System (CRS). HV in the MO group was reduced from 30 (range, 20 to 44) to 15 (range, 8 to 24) degrees and IM angle from 11 (range, 6 to 14) to 7 (range, 4 to 11) degrees. HV in the CO group was reduced from 31 (range, 22 to 42) to 16 (range, 6 to 24) degrees and IM angle from 14 (range, 8 to 20) to 6 (range, 2 to 10) degrees. Transfer metatarsalgia occurred in 36 (60%) patients and hammertoe in 6 (10%) patients in the MO group. In the CO group, metatarsalgia occurred in 5 patients. The median loss of postoperative HV correction was 4 (range, 2 to 10) degrees in mild deformity and 6 (6 to 10) degrees in moderate deformity. Patients treated with CO had significantly better results for AOFAS CRS, number of postoperative complications, patient satisfaction, and length of sick leave for the employed patients. Based on our results, we consider that in female patients CO should be regarded as the first-line procedure for treatment of mild and moderate HV. Level I, prospective randomized study. © The Author(s) 2014.

ERic Acute StrokE Recanalization: A study using predictive analytics to assess a new device for mechanical thrombectomy.

PubMed

Siemonsen, Susanne; Forkert, Nils D; Bernhardt, Martina; Thomalla, Götz; Bendszus, Martin; Fiehler, Jens

2017-08-01

Aim and hypothesis Using a new study design, we investigate whether next-generation mechanical thrombectomy devices improve clinical outcomes in ischemic stroke patients. We hypothesize that this new methodology is superior to intravenous tissue plasminogen activator therapy alone. Methods and design ERic Acute StrokE Recanalization is an investigator-initiated prospective single-arm, multicenter, controlled, open label study to compare the safety and effectiveness of a new recanalization device and distal access catheter in acute ischemic stroke patients with symptoms attributable to acute ischemic stroke and vessel occlusion of the internal cerebral artery or middle cerebral artery. Study outcome The primary effectiveness endpoint is the volume of saved tissue. Volume of saved tissue is defined as difference of the actual infarct volume and the brain volume that is predicted to develop infarction by using an optimized high-level machine learning model that is trained on data from a historical cohort treated with IV tissue plasminogen activator. Sample size estimates Based on own preliminary data, 45 patients fulfilling all inclusion criteria need to complete the study to show an efficacy >38% with a power of 80% and a one-sided alpha error risk of 0.05 (based on a one sample t-test). Discussion ERic Acute StrokE Recanalization is the first prospective study in interventional stroke therapy to use predictive analytics as primary and secondary endpoint. Such trial design cannot replace randomized controlled trials with clinical endpoints. However, ERic Acute StrokE Recanalization could serve as an exemplary trial design for evaluating nonpivotal neurovascular interventions.

Topical silver sulfadiazine vs collagenase ointment for the treatment of partial thickness burns in children: a prospective randomized trial.

PubMed

Ostlie, Daniel J; Juang, David; Aguayo, Pablo; Pettiford-Cunningham, Janine P; Erkmann, Erin A; Rash, Diane E; Sharp, Susan W; Sharp, Ronald J; St Peter, Shawn D

2012-06-01

The 2 most commonly used topical agents for partial thickness burns are silver sulfadiazine (SSD) and collagenase ointment (CO). Silver sulfadiazine holds antibacterial properties, and eschar separation occurs naturally. Collagenase ointment is an enzyme that cleaves denatured collagen facilitating separation but has no antibacterial properties. Currently, there are no prospective comparative data in children for these 2 agents. Therefore, we conducted a prospective randomized trial. After institutional review board approval, patients were randomized to daily debridement with SSD or CO. Primary outcome was the need for skin grafting. Patients were treated for 2 days with SSD with subsequent randomization. Polymyxin was mixed with CO for antibacterial coverage. Debridements were performed daily for 10 days or until the burn healed. Grafting was performed after 10 days if not healed. From January 2008 to January 2011, 100 patients were enrolled, with no differences in patient characteristics. There were no differences in clinical course, outcome, or need for skin grafting. Wound infections occurred in 7 patients treated with CO and 1 patient treated with SSD (P = .06). Collagenase ointment was more expensive than SSD (P < .001). However, total hospital charges did not differ. There are no differences in outcomes between topical SSD or CO in the management of childhood burns results. Copyright © 2012 Elsevier Inc. All rights reserved.

The effect of ursodeoxycholic acid in liver functional restoration of patients with obstructive jaundice after endoscopic treatment: a prospective, randomized, and controlled study.

PubMed

Fekaj, Enver; Gjata, Arben; Maxhuni, Mehmet

2013-09-22

In patients with obstructive jaundice, multi-organ dysfunction may develop. This trial is a prospective, open-label, randomized, and controlled study with the objective to evaluate the effect of ursodeoxycholic acid in liver functional restoration in patients with obstructive jaundice after endoscopic treatment. The aim of this study is to evaluate the effect of ursodeoxycholic acid in liver functional restoration of patients with obstructive jaundice after endoscopic treatment. The hypothesis of this trial is that patients with obstructive jaundice, in which will be administered UDCA, in the early phase after endoscopic intervention will have better and faster functional restoration of the liver than patients in the control group.Patients with obstructive jaundice, randomly, will be divided into two groups: (A) test group in which will be administered ursodeoxycholic acid twenty-four hours after endoscopic procedure and will last fourteen days, and (B) control group.Serum-testing will include determination of bilirubin, alanine transaminase, aspartate transaminase, gama-glutamil transpeptidase, alkaline phosphatase, albumin, and cholesterol levels. These parameters will be determined one day prior endoscopic procedure, and on the third, fifth, seventh, tenth, twelfth and fourteenth days after endoscopic intervention. This trial is a prospective, open-label, randomized, and controlled study to asses the effect of ursodeoxycholic acid in liver functional restoration of patients with obstructive jaundice in the early phase after endoscopic treatment.

Sleep-Disordered Breathing in Chronic SCI: A Randomized Controlled Trial of Treatment Impact on Cognition, Quality of Life, and Cardiovascular Disease

DTIC Science & Technology

2014-10-01

SCI. In this prospective randomized controlled trial, we will objectively measure sleep disordered breathing ( SDB ) in chronic SCI patients using...portable sleep studies, and systematically evaluate the association between SDB , cognitive performance, mood, pain, and CV measures. We will randomize...randomized shortly. 15. SUBJECT TERMS SDB , SCI, PAP, CV 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF ABSTRACT 18. NUMBER OF PAGES 19a

Knowledge translation strategies for enhancing nurses' evidence-informed decision making: a scoping review.

PubMed

Yost, Jennifer; Thompson, David; Ganann, Rebecca; Aloweni, Fazila; Newman, Kristine; McKibbon, Ann; Dobbins, Maureen; Ciliska, Donna

2014-06-01

Nurses are increasingly expected to engage in evidence-informed decision making (EIDM); the use of research evidence with information about patient preferences, clinical context and resources, and their clinical expertise in decision making. Strategies for enhancing EIDM have been synthesized in high-quality systematic reviews, yet most relate to physicians or mixed disciplines. Existing reviews, specific to nursing, have not captured a broad range of strategies for promoting the knowledge and skills for EIDM, patient outcomes as a result of EIDM, or contextual information for why these strategies "work." To conduct a scoping review to identify and map the literature related to strategies implemented among nurses in tertiary care for promoting EIDM knowledge, skills, and behaviours, as well as patient outcomes and contextual implementation details. A search strategy was developed and executed to identify relevant research evidence. Participants included registered nurses, clinical nurse specialists, nurse practitioners, and advanced practice nurses. Strategies were those enhancing nurses' EIDM knowledge, skills, or behaviours, as well as patient outcomes. Relevant studies included systematic reviews, randomized controlled trials, cluster randomized controlled trials, non-randomized trials (including controlled before and after studies), cluster non-randomized trials, interrupted time series designs, prospective cohort studies, mixed-method studies, and qualitative studies. Two reviewers performed study selection and data extraction using standardized forms. Disagreements were resolved through discussion or third party adjudication. Using a narrative synthesis, the body of research was mapped by design, clinical areas, strategies, and provider and patient outcomes to determine areas appropriate for a systematic review. There are a sufficiently high number of studies to conduct a more focused systematic review by care settings, study design, implementation strategies, or outcomes. A focused review could assist in determining which strategies can be recommended for enhancing EIDM knowledge, skills, and behaviours among nurses in tertiary care. © 2014 The Authors. Worldviews on Evidence-Based Nursing published by Wiley Periodicals, Inc. on behalf of Sigma Theta Tau International.

High-dose N-acetylcysteine in the prevention of COPD exacerbations: rationale and design of the PANTHEON Study.

PubMed

Zheng, Jin-Ping; Wen, Fu-Qiang; Bai, Chun-Xue; Wan, Huan-Ying; Kang, Jian; Chen, Ping; Yao, Wan-Zhen; Ma, Li-Jun; Xia, Qi-Kui; Gao, Yi; Zhong, Nan-Shan

2013-04-01

Chronic obstructive pulmonary disease (COPD) is characterized by persistent airflow limitation; from a pathophysiological point of view it involves many components, including mucus hypersecretion, oxidative stress and inflammation. N-acetylcysteine (NAC) is a mucolytic agent with antioxidant and anti-inflammatory properties. Long-term efficacy of NAC 600mg/d in COPD is controversial; a dose-effect relationship has been demonstrated, but at present it is not known whether a higher dose provides clinical benefits. The PANTHEON Study is a prospective, ICS stratified, randomized, double-blind, placebo-controlled, parallel-group, multi-center trial designed to assess the efficacy and safety of high-dose (1200 mg/daily) NAC treatment for one year in moderate-to-severe COPD patients. The primary endpoint is the annual exacerbation rate. Secondary endpoints include recurrent exacerbations hazard ratio, time to first exacerbation, as well as quality of life and pulmonary function. The hypothesis, design and methodology are described and baseline characteristics of recruited patients are presented. 1006 COPD patients (444 treated with maintenance ICS, 562 ICS naive, aged 66.27±8.76 yrs, average post-bronchodilator FEV1 48.95±11.80 of predicted) have been randomized at 34 hospitals in China. Final results of this study will provide objective data on the effects of high-dose (1200 mg/daily) long-term NAC treatment in the prevention of COPD exacerbations and other outcome variables.

Nutritional Recovery after Open and Laparoscopic Distal Gastrectomy for Early Gastric Cancer: A Prospective Multicenter Comparative Trial (CCOG1204).

PubMed

Matsushita, Hidenobu; Tanaka, Chie; Murotani, Kenta; Misawa, Kazunari; Ito, Seiji; Ito, Yuichi; Kanda, Mitsuro; Mochizuki, Yoshinari; Ishigure, Kiyoshi; Yaguchi, Toyohisa; Teramoto, Jin; Nakayama, Hiroshi; Kawase, Yoshihisa; Fujiwara, Michitaka; Kodera, Yasuhiro

2018-01-01

Little information from prospective clinical trials is available on the influences of surgical approaches on postoperative body compositions and nutritional status. We designed a prospective non-randomized trial to compare postoperative chronological changes in body composition and nutritional status between laparoscopic and open distal gastrectomy for stage I gastric cancer (GC). Body compositions and nutritional indicators in blood tests were measured at the baseline and at the 1st, 3rd, 6th, and 12th postoperative months (POM). The primary end point was the decrease relative to the baseline in the body muscle mass at POM 6. Ninety-six patients for the laparoscopic group and 52 for the open group were eligible for data analysis. No significant differences were found in any baseline demographics, body compositions, and nutritional indicators between the groups. The changes of body muscle mass at POM 6 were similar in both groups. Overall, no significant differences between the groups were observed in any of the body composition and nutritional indicators during the first year after surgery. Postoperative body compositions and nutritional status were not affected by surgical approaches during the first 12 months after surgery in patients who underwent distal gastrectomy for stage I GC. © 2017 S. Karger AG, Basel.

Are Locking Constructs in Distal Femoral Fractures Always Best? A Prospective Multicenter Randomized Controlled Trial Comparing the Less Invasive Stabilization System With the Minimally Invasive Dynamic Condylar Screw System.

PubMed

2016-01-01

The purpose of this clinical study is to determine whether the rate of fracture healing and fracture union, repaired with a locked device, will be as good as or better than standard nonlocking bicortical fixation in distal femoral fractures. Institutional review board-approved, multicenter prospective randomized controlled trial. Seven level 1 trauma centers across Canada. Fifty-two patients with distal femoral fractures (AO/OTA 33A1 to 33C2) were enrolled in the randomized trial. Twelve AO/OTA 33C3 fractures were excluded from the randomized trial but followed up as a nonrandomized cohort. Patients were treated through a standardized minimally invasive approach. Fractures were randomized 1:1 to treatment with the locked Less Invasive Stabilization System (LISS; Synthes, Paoli, PA) or the dynamic condylar screw (DCS). The nonrandomized cohort was treated at the surgeon's discretion. Primary outcomes were time to radiological union and number of delayed/nonunions at 12 months. Secondary outcomes were postoperative function and complications. Fifty-two patients were randomized including 34 women and 18 men. The mean age was 59 years. Twenty-eight patients were treated with the LISS and 24 with the DCS. There was no statistically significant difference between the LISS and the DCS in terms of the number of fractures healed, time to union, or functional scores. Complications and revisions were more common in the LISS group. There were 7 reoperations in the LISS group and one in the DCS group. Only 52% of the LISS group healed without intervention by 12 months compared with 91% in the DCS group. There was no advantage to the locking plate design in the management of distal femoral fractures in this study. The higher cost of the locking plates, challenges in technique, and lack of superiority have led the authors to discontinue the use of this lateral unicortical locking device in favor of other devices that allow locked or nonlocked bicortical fixation, articular compression, and bridging of the comminuted fracture segments. The cost-effective treatment for a subgroup or periarticular fractures may be a fixed-angle nonlocked device in patients with reasonable bone quality. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Adequacy in dialysis: intermittent versus continuous therapies.

PubMed

Misra, M; Nolph, K D

2000-01-01

A vital conceptual difference between intermittent and continuous dialysis therapies is the difference in the relationship between Kt/V urea and dietary protein intake. For a given level of protein intake the intermittent therapies require a higher Kt/V urea due to the reasons mentioned above. The recently released adequacy guidelines by DOQI for intermittent and continuous therapies are based on these assumptions. The link between adequacy targets and patient survival is well documented for an intermittent therapy like HD. For a continuous therapy like CAPD however, the evidence linking improved peritoneal clearance to better survival is not as direct. However, present consensus allows one to extrapolate results based on HD. The concept of earlier and healthier initiation of dialysis is gaining hold and incremental dialysis forms an integral aspect of the whole concept. Tools like urea kinetic modeling give us valuable insight in making mathematical projections about the timing as well as dosing of dialysis. Daily home hemodialysis is still an underutilized modality despite offering best survival figures. Hopefully, with increasing availability of better and simpler machines its use will increase. Still several questions remain unanswered. Despite availability of data in hemodialysis patients suggesting that an increased dialysis prescription leads to a better survival, optimal dialysis dose is yet to be defined. Concerns regarding methodology of such studies and conclusions thereof has been raised. Other issues relating to design of the studies, variation in dialysis delivery, use of uncontrolled historical standards and lack of patient randomization etc also need to be considered when designing such trials. Hopefully an ongoing prospective randomized trial, namely the HEMO study, looking at two precisely defined and carefully maintained dialysis prescriptions will provide some insight into adequacy of dialysis dose and survival. In diabetic patients, the relationship between outcome and dialysis dose needs to be better defined. Data relating adequacy of dialysis to outcome in a pediatric population is not available. In dialysis therapy, the Risk/Dose (R/D) function does not bear a linear relationship. This together with a lack of proof equating peritoneal to renal clearance lends some uncertainty to the validity of the recommendation that there is a linear and constant decrease in RR for std (Kt/V) [equivalent standardized Kt/V calculated from average predialysis BUN for any frequency and/or combination of intermittent and continuous dialysis ref] up to 2.3 as reported in the CANUSA study. Due to the complex nature of this problem it may be prudent to undertake a multi-center trial with std (Kt/V) prospectively randomized to either 2.0 or 2.4. This would provide a reliable database to evaluate the R/D function over this critical range of normalized peritoneal urea clearance. Likewise in PD, the postulated linearity between dialysis dose and outcome needs to be studied in a prospective randomized manner. The amount of dialysis dose required for malnourished patients, diabetic and pediatric patients needs to be better defined. The role of aggressive dialysis in reversing malnutrition needs to be studied and studies need to be done to identify the most scientific use of V in malnourished patients. Justification of a healthy start/incremental dialysis based on outcome measures needs to be established and it's cost effectiveness validated by clinical trials. Again, a prospective randomized controlled trial comparing incremental dialysis with dietary protein restriction in patients with GFR < or = 10.5 ml/min/1.73 m2 with properly defined outcome measures like morbidity, mortality, decline of GFR and quality of life needs to be conducted. Comparisons of incremental hemodialysis and incremental peritoneal dialysis need to be made especially with regard to technique survival and preservation of residual renal function (RRF). (ABSTR

A Randomized Trial of Genetic and Environmental Risk Assessment (GERA) for Colorectal Cancer Risk in Primary Care: Trial Design and Baseline Findings

PubMed Central

Myers, Ronald E.; Manne, Sharon L.; Wilfond, Benjamin; Sifri, Randa; Ziring, Barry; Wolf, Thomas A.; Cocroft, James; Ueland, Amy; Petrich, Anett; Swan, Heidi; DiCarlo, Melissa; Weinberg, David S.

2010-01-01

Purpose This paper describes an ongoing randomized controlled trial designed to assess the impact of genetic and environmental risk assessment (GERA) on colorectal cancer (CRC) screening. Methods The trial includes asymptomatic patients who are 50-79 years and are not up-to-date with CRC screening guidelines. Patients who responded to a baseline telephone survey are randomized to a GERA or Control group. GERA Group participants meet with a nurse, decide whether to have a GERA blood test (a combination of genetic polymorphism and folate), and, if tested, receive GERA feedback. Follow-up telephone surveys are conducted at one and six months. A chart audit is performed at six months. Results Of 2,223 eligible patients, 562 (25%) have enrolled. Patients who enrolled in the study were significantly younger than those who did not (p<0.001). Participants tended to be 50-59 years (64%), female (58%), white (52%), married (51%), and have more than a high school education (67%). At baseline, most participants had some knowledge of CRC screening and GERA, viewed CRC screening favorably, and reported that they had decided to do screening. Almost half had worries and concerns about CRC. Conclusions One in four eligible primary care patients enrolled in the study. Age was negatively associated with enrollment. Prospective analyses using data for all participants will provide more definitive information on GERA uptake and the impact of GERA feedback. PMID:20828635

A randomized trial of genetic and environmental risk assessment (GERA) for colorectal cancer risk in primary care: trial design and baseline findings.

PubMed

Myers, Ronald E; Manne, Sharon L; Wilfond, Benjamin; Sifri, Randa; Ziring, Barry; Wolf, Thomas A; Cocroft, James; Ueland, Amy; Petrich, Anett; Swan, Heidi; DiCarlo, Melissa; Weinberg, David S

2011-01-01

This paper describes an ongoing randomized controlled trial designed to assess the impact of genetic and environmental risk assessment (GERA) on colorectal cancer (CRC) screening. The trial includes asymptomatic patients who are 50-79years and are not up-to-date with CRC screening guidelines. Patients who responded to a baseline telephone survey are randomized to a GERA or Control group. GERA group participants meet with a nurse, decide whether to have a GERA blood test (a combination of genetic polymorphism and folate), and, if tested, receive GERA feedback. Follow-up telephone surveys are conducted at 1 and 6months. A chart audit is performed at 6months. Of 2,223 eligible patients, 562 (25%) have enrolled. Patients who enrolled in the study were significantly younger than those who did not (p<0.001). Participants tended to be 50-59years (64%), female (58%), white (52%), married (51%), and have more than a high school education (67%). At baseline, most participants had some knowledge of CRC screening and GERA, viewed CRC screening favorably, and reported that they had decided to do screening. Almost half had worries and concerns about CRC. One in four eligible primary care patients enrolled in the study. Age was negatively associated with enrollment. Prospective analyses using data for all participants will provide more definitive information on GERA uptake and the impact of GERA feedback. Copyright © 2010 Elsevier Inc. All rights reserved.

Design and Implementation of a Randomized Controlled Trial of Genomic Counseling for Patients with Chronic Disease

PubMed Central

Sweet, Kevin; Gordon, Erynn S.; Sturm, Amy C.; Schmidlen, Tara J.; Manickam, Kandamurugu; Toland, Amanda Ewart; Keller, Margaret A.; Stack, Catharine B.; García-España, J. Felipe; Bellafante, Mark; Tayal, Neeraj; Embi, Peter; Binkley, Philip; Hershberger, Ray E.; Sadee, Wolfgang; Christman, Michael; Marsh, Clay

2014-01-01

We describe the development and implementation of a randomized controlled trial to investigate the impact of genomic counseling on a cohort of patients with heart failure (HF) or hypertension (HTN), managed at a large academic medical center, the Ohio State University Wexner Medical Center (OSUWMC). Our study is built upon the existing Coriell Personalized Medicine Collaborative (CPMC®). OSUWMC patient participants with chronic disease (CD) receive eight actionable complex disease and one pharmacogenomic test report through the CPMC® web portal. Participants are randomized to either the in-person post-test genomic counseling—active arm, versus web-based only return of results—control arm. Study-specific surveys measure: (1) change in risk perception; (2) knowledge retention; (3) perceived personal control; (4) health behavior change; and, for the active arm (5), overall satisfaction with genomic counseling. This ongoing partnership has spurred creation of both infrastructure and procedures necessary for the implementation of genomics and genomic counseling in clinical care and clinical research. This included creation of a comprehensive informed consent document and processes for prospective return of actionable results for multiple complex diseases and pharmacogenomics (PGx) through a web portal, and integration of genomic data files and clinical decision support into an EPIC-based electronic medical record. We present this partnership, the infrastructure, genomic counseling approach, and the challenges that arose in the design and conduct of this ongoing trial to inform subsequent collaborative efforts and best genomic counseling practices. PMID:24926413

Postoperative therapy with infliximab for Crohn's disease: a 2-year prospective randomized multicenter study in Japan.

PubMed

Fukushima, Kouhei; Sugita, Akira; Futami, Kitaro; Takahashi, Ken-Ichi; Motoya, Satoshi; Kimura, Hideaki; Yoshikawa, Shusaku; Kinouchi, Yoshitaka; Iijima, Hideki; Endo, Katsuya; Hibi, Toshihumi; Watanabe, Mamoru; Sasaki, Iwao; Suzuki, Yasuo

2018-06-01

The prevention of postoperative recurrence is a critical issue in surgery for Crohn's disease. Prospective randomized trials in Western countries have shown that the postoperative use of anti-tumor necrosis factor α-antibodies was effective in reducing the recurrence rate. We investigated the efficacy of infliximab (IFX) for the prevention of postoperative Crohn's disease recurrence. We performed a prospective randomized multicenter study. Patients who underwent intestinal resection were assigned to groups treated with or without IFX. Immediately after surgery, patients in the IFX group received IFX at 5 mg/kg at 0, 2, and 6 weeks, followed by every 8 weeks for 2 years. The primary study outcome was the proportion of patients with endoscopic and/or clinical recurrence at 2 years after surgery. Thirty-eight eligible patients participated in this study: 19 in the IFX group and 19 in the non-IFX group. The disease recurrence rate in the IFX group was 52.6% (10/19), which was significantly lower than that in the non-IFX group (94.7% [18/19]). The postoperative use of IFX is effective in preventing Crohn's disease recurrence for 2 years.

Long-term forecasting and comparison of mortality in the Evaluation of the Xience Everolimus Eluting Stent vs. Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial: prospective validation of the SYNTAX Score II.

PubMed

Campos, Carlos M; van Klaveren, David; Farooq, Vasim; Simonton, Charles A; Kappetein, Arie-Pieter; Sabik, Joseph F; Steyerberg, Ewout W; Stone, Gregg W; Serruys, Patrick W

2015-05-21

To prospectively validate the SYNTAX Score II and forecast the outcomes of the randomized Evaluation of the Xience Everolimus-Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) Trial. Evaluation of the Xience Everolimus Eluting Stent vs. Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization is a prospective, randomized multicenter trial designed to establish the efficacy and safety of percutaneous coronary intervention (PCI) with the everolimus-eluting stent compared with coronary artery bypass graft (CABG) surgery in subjects with unprotected left-main coronary artery (ULMCA) disease and low-intermediate anatomical SYNTAX scores (<33). After completion of patient recruitment in EXCEL, the SYNTAX Score II was prospectively applied to predict 4-year mortality in the CABG and PCI arms. The 95% prediction intervals (PIs) for mortality were computed using simulation with bootstrap resampling (10 000 times). For the entire study cohort, the 4-year predicted mortalities were 8.5 and 10.5% in the PCI and CABG arms, respectively [odds ratios (OR) 0.79; 95% PI 0.43-1.50). In subjects with low (≤22) anatomical SYNTAX scores, the predicted OR was 0.69 (95% PI 0.34-1.45); in intermediate anatomical SYNTAX scores (23-32), the predicted OR was 0.93 (95% PI 0.53-1.62). Based on 4-year mortality predictions in EXCEL, clinical characteristics shifted long-term mortality predictions either in favour of PCI (older age, male gender and COPD) or CABG (younger age, lower creatinine clearance, female gender, reduced left ventricular ejection fraction). The SYNTAX Score II indicates at least an equipoise for long-term mortality between CABG and PCI in subjects with ULMCA disease up to an intermediate anatomical complexity. Both anatomical and clinical characteristics had a clear impact on long-term mortality predictions and decision making between CABG and PCI. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

Development of Metacognitive Skills: Designing Problem-Based Experiment with Prospective Science Teachers in Biology Laboratory

ERIC Educational Resources Information Center

Denis Çeliker, Huriye

2015-01-01

The purpose of this study is to investigate the effect of designing problem-based experiments (DPBE) on the level of metacognitive skills of prospective science teachers. For this purpose, pre test-post test design, without control group, was used in the research. The research group of the study comprised 113 second-grade prospective science…

Evaluation of a cancer patient navigation program ("Onkolotse") in terms of hospitalization rates, resource use and healthcare costs: rationale and design of a randomized, controlled study.

PubMed

Porzig, Ralf; Neugebauer, Sina; Heckmann, Thomas; Adolf, Daniela; Kaskel, Peter; Froster, Ursula G

2018-06-05

Concepts for the nursing and care of cancer patients through a "navigation service" have attracted much interest. However, there is still room for improvement in terms of their funding and coverage. The Saxon Cancer Society designed a prospective, randomized, multicenter, longitudinal study with a view to determining the positive effects of a cancer patient navigator program. The objective of this ongoing study is to evaluate the impact of the cancer patient navigation program on cancer patients and cost bearers in Germany. The study population in this evaluation comprises cancer patients with gastric carcinoma, pancreatic carcinoma, colorectal cancer, melanoma or gynecological cancer who have been hospitalized at least once at one of the study centers as well as their relatives, outpatient and inpatient physicians, and cancer nurses. It is planned to randomize 340 cancer patients (stomach, colonic/rectal cancer, gynecological cancer, melanoma) at five centers to an intervention group (care by patient navigators based on standardized operating procedures) or a control group in a one-to-one ratio. The primary target parameter is the number of hospitalizations within the 12-month intervention period. The participants are asked to complete various questionnaires on patient-related outcomes at baseline and at 3 and 12 months (SF 36, HADS, PAM 13, and others). Data on drug therapy, utilization of health services, and medical expenses will also be analyzed. For the first time, the study will provide data on the effectiveness of a patient support program in cancer care in Germany from a randomized trial with a high level of evidence. The study has been registered under DRKS00013199 in the German Clinical Trials Register.

Handwashing with soap or alcoholic solutions? A randomized clinical trial of its effectiveness.

PubMed

Zaragoza, M; Sallés, M; Gomez, J; Bayas, J M; Trilla, A

1999-06-01

The effectiveness of an alcoholic solution compared with the standard hygienic handwashing procedure during regular work in clinical wards and intensive care units of a large public university hospital in Barcelona was assessed. A prospective, randomized clinical trial with crossover design, paired data, and blind evaluation was done. Eligible health care workers (HCWs) included permanent and temporary HCWs of wards and intensive care units. From each category, a random sample of persons was selected. HCWs were randomly assigned to regular handwashing (liquid soap and water) or handwashing with the alcoholic solution by using a crossover design. The number of colony-forming units on agar plates from hands printing in 3 different samples was counted. A total of 47 HCWs were included. The average reduction in the number of colony-forming units from samples before handwashing to samples after handwashing was 49.6% for soap and water and 88.2% for the alcoholic solution. When both methods were compared, the average number of colony-forming units recovered after the procedure showed a statistically significant difference in favor of the alcoholic solution (P <.001). The alcoholic solution was well tolerated by HCWs. Overall acceptance rate was classified as "good" by 72% of HCWs after 2 weeks use. Of all HCWs included, 9.3% stated that the use of the alcoholic solution worsened minor pre-existing skin conditions. Although the regular use of hygienic soap and water handwashing procedures is the gold standard, the use of alcoholic solutions is effective and safe and deserves more attention, especially in situations in which the handwashing compliance rate is hampered by architectural problems (lack of sinks) or nursing work overload.

Overview of the epidemiology methods and applications: strengths and limitations of observational study designs.

PubMed

Colditz, Graham A

2010-01-01

The impact of study design on the results of medical research has long been an area of both substantial debate and a smaller body of empirical research. Examples come from many disciplines within clinical and public health research. Among the early major contributions in the 1970s was work by Mosteller and colleagues (Gilbert et al., 1997), who noted that innovations in surgery and anesthesia showed greater gains than standard therapy when nonrandomized, controlled trials were evaluated compared with the gains reported in randomized, controlled trials. More recently, we and others have evaluated the impact of design in medical and surgical research, and concluded that the mean gain comparing new therapies to established therapies was biased by study design in nonrandomized trials (Colditz et al., 1989; Miller et al., 1989). Benson and Hartz (2000) conducted a study in which they focused only on studies reported after 1985. On the basis of 136 reports of 19 diverse treatments, Benson and Hartz concluded that in only 2 of the 19 analyses did the combined data from the observational studies lie outside the 95% confidence interval for the combined data from the randomized trials. A similar study drew only on data reported from 1991 to 1995, which showed remarkably similar results among observational studies and randomized, controlled trials (Concato et al., 2000). These more recent data suggest that advancing the study design and analytic methods may reduce bias in some evaluations of medical and public health interventions. Such methods apply not only to the original studies, but also to the approaches that are taken to quantitatively combine results by using meta-analytic approaches such as random effects meta-regression, Bayesian meta-analysis, and the like (Normand, 1999). By focusing attention on thorough data analysis, design issues can be understood and their impact or bias can be estimated, on average, and then ideally accounted for in the interpretation of data. Before discussing dietary data, let us first consider some of the more clearly delineated preventive exposures. Issues of study design have been addressed in terms of combining randomized trials and observational studies in evaluating preventive interventions such as Bacillus Calmette-Guerin vaccination (Colditz et al., 1994) and mammography screening (Desmissie et al., 1998). When one is interpreting the apparent heterogeneity in the results, it is important to step back and ask what is the relationship being evaluated under these different study designs? For example, a randomized, controlled trial uses the intention-to-treat analysis to preserve the merit of randomization. Such an analysis does not evaluate the exposure-disease relationship, but rather examines the impact of offering a new therapy versus an alternative therapy (regardless of adherence to the intervention, or control or placebo). On the other hand, a case-control study or a prospective cohort study will evaluate the impact of the screening test among those participants who were screened as compared with those who were never screened. In prevention studies, the design raises major issues of the timing of the exposure in the natural history of disease and also the adherence to therapy by healthy research volunteers. Case-control studies of preventive interventions such as screening mammography and prospective population-based studies of pap smears have capitalized on this variation in time since the last screen to evaluate the protective interval for a screening test (IARC Work Group, 1986). In contrast, a trial must choose a level of exposure, such as annual mammography screenings or colon screenings every 10 years with a colonoscopy, regardless of the evolving evidence on the duration of protection after a negative screening test. Continuing with the mammography example, a detailed study by Demissie and colleagues (1998) combined data from seven randomized trials and six case-control studies that investigated the association between participation in breast cancer screening programs and breast cancer mortality. The authors showed that if one assumes noncompliance with mammography (approaching 30%) and 20% of the control group is screened, then the benefit of mammography in terms of reduced mortality is comparable in randomized, controlled trials and epidemiologic studies after adjusting for nonadherence (Demissie et al., 1998). Thus, the different designs fundamentally measure different constructs of the impact of screening. Zelen (1988) considered the challenges of primary prevention trials and addressed both compliance and models of carcinogenesis as major impediments to the use of randomized, controlled trials to evaluate cancer prevention strategies. It is important to contrast these issues in both treatment trials and prevention trials. In treatment trials, recently diagnosed patients, who are often in life-threatening situations, are typically offered the option to participate in a trial of a new therapy compared with standard therapy or placebo. Compliance or adherence to therapy is usually very high among these highly motivated patients and their outcomes are generally in the short- to mid-term. In contrast, prevention trials recruit large numbers of healthy participants, offer them a therapy, and then follow them over many years because the chronic diseases being prevented are relatively rare. With substantial noncompliance (often in the range of 20% to 40% over the duration of the trial), an intention-to-treat analysis is no longer unbiased, but rather gives a biased estimate of the effect, typically underestimating the magnitude of the association that is seen in observation studies in which those participants who have had exposure to a particular lifestyle component are compared with those without such an exposure. There are additional challenges for nutritional interventions, including the timing of diet as a preventive agent in the disease process and the range of nutrient intakes in the population. In retrospective case-control studies, recall bias of past diet is an additional issue with which to contend. Unlike smoking or screening tests in which the exposure is finite and can be completely stopped and started, one's diet, physical activity, and weight change cannot go to zero for prolonged periods and sustain life. The range of nutrient intake is a major issue when enrolling participants into prevention trials and observational studies. Health-conscious volunteers are more often identified and screened as eligible for a trial. The epidemiology of diet and colon cancer has been extensively studied. For example, Cho et al. (2004) conducted a combined analysis of prospective dietary studies of calcium and vitamin D intake data from 10 cohorts. The dose-response relationship for calcium showed that the greatest benefit for increasing calcium intake was for those participants who had a reported daily intake below 1000 mg/d. Increasing the intake of those individuals with low intake to the level of 1000 mg/day would yield a 20% reduction in risk. Beyond this level of intake, there was little additional reduction in the risk of colon cancer. In the Women's Health Initiative, participants had a mean calcium intake of 1150 mg/d at baseline and increased this intake in the intervention arm to 2250 mg/d on average. This magnitude of increase was of limited association in the combined, prospective, cohort studies and was not related to risk in the randomized trial (Wactawski-Wende et al., 2006). Similar findings apply to the interpretation of the vitamin D intervention and highlight the role of dietary intake at randomization when evaluating dietary components. Returning to the time frame of exposure in the carcinogenic process, the null randomized, controlled trials of fiber (Alberts et al., 2000) and fruit and vegetables (Schatzkin et al., 2000) for the prevention of polyp recurrence amply illustrate Zelen's concerns regarding the timing of the preventive intervention in the disease process. The extent of DNA damage accumulated across the colonic mucosa at the time of detecting the "eligibility polyp" was certainly not limited only to the removed polyp. Rather, these observations beg the question that at what stage in the disease process may fiber play a role in protecting against colon cancer? This contrasts with the richness of epidemiologic studies that can address exposure over the life course and relate such exposure to disease risk. Perhaps the best-known example is the radiation follow-up effects cohort in Japan in which a radiation dose was estimated for each woman who had been exposed to the effects of the atomic bombs on Hiroshima and Nagasaki and followed-up over 40 years. The results of this study showed a clear and strong relationship between the increased risk of breast cancer with higher exposure among those participants who were exposed before the age of 20 years (Land et al., 2003). Retrospective assessment of diet after disease diagnosis has been demonstrated to introduce bias into the evaluation of exposure-disease relationships. For example, Giovannucci et al. (1993) evaluated retrospective recall of diet after breast cancer diagnosis within the ongoing Nurses' Health Study. In contrast with the prospective analysis in which no relationship between dietary fat and breast cancer was observed, the retrospective analysis yielded a positive relationship for total fat and saturated fat (Giovannucci et al., 1993). By comparing the top quintile versus the bottom quintile of reported intake, the retrospective assessment yielded odds ratios of 1.43 for total fat and 1.38 for saturated fat. Therefore, the magnitude of bias was sufficient to distort evaluation of the diet-disease relationship. (ABSTRACT TRUNCATED)

Comparison of the effects of magnesium and ketamine on postoperative pain and morphine consumption. A double-blind randomized controlled clinical study.

PubMed

Arıkan, Müge; Aslan, Bilge; Arıkan, Osman; Horasanlı, Eyüp; But, Abdulkadir

2016-01-01

To compare the effects of magnesium sulfate and ketamine on postoperative pain and total morphine consumption in a placebo-controlled design. One hundred and twenty women scheduled for total abdominal hysterectomy were included in this prospective, randomized, double-blind study. Postoperatively, when the Numeric Pain Rating Scale (NPRS) was four or more, IV-PCA morphine was applied to all patients. The patients were randomized into three groups: Group K ketamine, Group M magnesium, and Group C saline received as infusion. Total morphine consumption for 48h, pain scores, adverse effects, and patients' satisfaction were evaluated. Total morphine consumption was significantly lower in Group K (32.6±9.2 mg) than in Group M (58.9±6.5 mg) and in Group C (65.7±8.2 mg). The satisfaction level of patients in Group K was higher than the other two groups (p<0.05). Pruritus and nausea were observed more frequently in Group C. CONCLUSİON: The addition of ketamine to IV-PCA morphine reduces the total consumption of morphine without psychotic effects; however, magnesium did not influence morphine consumption.

Clinical and microbiologic effects of commercially available dentifrice containing aloe vera: a randomized controlled clinical trial.

PubMed

Pradeep, A R; Agarwal, Esha; Naik, Savitha B

2012-06-01

Certain plants used in folk medicine serve as a source of therapeutic agents that have antimicrobial and other multipotential effects. This prospective, randomized, placebo, and positively controlled clinical trial was designed to evaluate the clinical and microbiologic effects of a commercially available dentifrice containing aloe vera on the reduction of plaque and gingival inflammation in patients with gingivitis. Ninety patients diagnosed with chronic generalized gingivitis were selected and randomly divided into three groups: group 1, placebo toothpaste; group 2, toothpaste containing aloe vera; and group 3, toothpaste with polymer and fluoride containing triclosan. Clinical evaluation was undertaken using a gingival index, plaque was assessed using a modification of the Quigley-Hein index, and microbiologic counts were assessed at baseline, 6 weeks, 12 weeks, and 24 weeks. A subjective evaluation was also undertaken by questionnaire. Toothpaste containing aloe vera showed significant improvement in gingival and plaque index scores as well as microbiologic counts compared with placebo dentifrice. These improvements were comparable to those achieved with toothpaste containing triclosan. Toothpaste containing aloe vera may be a useful herbal formulation for chemical plaque control agents and improvement in plaque and gingival status.

A multi-center randomized trial of two different intravenous fluids during labor

PubMed Central

DAPUZZO-ARGIRIOU, Lisa M.; SMULIAN, John C.; ROCHON, Meredith L.; GALDI, Luisa; KISSLING, Jessika M.; SCHNATZ, Peter F.; RIOS, Angel GONZALEZ; AIROLDI, James; CARRILLO, Mary Anne; MAINES, Jaimie; KUNSELMAN, Allen R.; REPKE, John; LEGRO, Richard S.

2017-01-01

Objective To determine if the intrapartum use of a 5% glucose-containing intravenous solution decreases the chance of a cesarean delivery for women presenting in active labor. Methods This was a multi-center, prospective, single (patient) blind, randomized study design implemented at 4 obstetric residency programs in Pennsylvania. Singleton, term, consenting women presenting in active spontaneous labor with a cervical dilation of <6cm were randomized to lactated Ringer's with or without 5% glucose (LR versus D5LR) as their maintenance intravenous fluid. The primary outcome was the cesarean birth rate. Secondary outcomes included labor characteristics, as well as maternal or neonatal complications. Results There were 309 women analyzed. Demographic variables and admitting cervical dilation were similar among study groups. There was no significant difference in the cesarean delivery rate for the D5LR group (23/153 or 15.0%) versus the LR arm (18/156 or 11.5%), [RR (95%CI) of 1.32 (0.75, 2.35), P=0.34]. There were no differences in augmentation rates or intrapartum complications. Conclusions The use of intravenous fluid containing 5% dextrose does not lower the chance of cesarean delivery for women admitted in active labor. PMID:25758624

Anesthetic efficacy of a repeated intraosseous injection following a primary intraosseous injection.

PubMed

Jensen, Joanne; Nusstein, John; Drum, Melissa; Reader, Al; Beck, Mike

2008-02-01

The purpose of this prospective, randomized, single-blinded study was to determine the anesthetic efficacy of a repeated intraosseous injection given 30 minutes after a primary intraosseous injection. Using a crossover design, 55 subjects randomly received a primary X-tip intraosseous injection (Dentsply Inc, York, PA) of 1.4 mL of 2% lidocaine with epinephrine (using the Wand; Milestone Scientific, Deerfield, IL) and a repeated intraosseous or mock injection at 30 minutes in two appointments. The first molar and adjacent teeth were pulp tested every 2 minutes for a total of 120 minutes. Success was defined as obtaining two consecutive 80 readings with the electric pulp tester. Success of the initial intraosseous injection was 100% for the first molar. The repeated intraosseous injection mimicked the initial intraosseous injection in terms of pulpal anesthesia and statistically provided another 15 minutes of pulpal anesthesia. In conclusion, using the methodology presented, repeating the intraosseous injection 30 minutes after an initial intraosseous injection will provide an additional 15 minutes of pulpal anesthesia.

Evaluating the efficacy of lavender aromatherapy on peripheral venous cannulation pain and anxiety: A prospective, randomized study.

PubMed

Karaman, Tugba; Karaman, Serkan; Dogru, Serkan; Tapar, Hakan; Sahin, Aynur; Suren, Mustafa; Arici, Semih; Kaya, Ziya

2016-05-01

This study was designed to evaluate the effectiveness of lavender aromatherapy on pain, anxiety, and level of satisfaction associated with the peripheral venous cannulation (PVC) in patients undergoing surgery. One hundred and six patients undergoing surgery were randomized to receive aromatherapy with lavender essential oil (the lavender group) or a placebo (the control group) during PVC. The patients' pain, anxiety, and satisfaction scores were measured. There was no statistically significantly difference between the groups in terms of demographic data. After cannulation, the pain and anxiety scores (anxiety 2) of the patients in the lavender group were significantly lower than the control group (for p = 0.01 for pain scores; p < 0.001 for anxiety 2 scores). In addition, patient satisfaction was significantly higher in the lavender group than in the control group (p = 0.003). Lavender aromatherapy had beneficial effects on PVC pain, anxiety, and satisfaction level of patients undergoing surgery. Copyright © 2016 Elsevier Ltd. All rights reserved.

Randomized controlled trials vs. observational studies: why not just live together?

PubMed

Faraoni, David; Schaefer, Simon Thomas

2016-10-21

Randomized controlled trials (RCTs) are considered the gold standard for clinical research, thus having a high impact on clinical guidelines and our daily patients' care. However, various treatment strategies which we consider "evidence based" have never been subject to a prospective RCT, as we would rate it unethical to withheld an established treatment to individuals in an placebo controlled trial.In a recent BMC Anesthesiology publication, Trentino et al. analyzed the usefulness of observational studies in assessing benefit and risk of different transfusion strategies. The authors nicely reviewed and summarized similarities and differences, advantages and limitations, between different study types frequently used in transfusion medicine. In this interesting article, the authors conclude, that 'when comparing the results of observational studies with RCTs assessing transfusion outcomes, it is important that one consider not only the study method, but also the key elements of the study design'. Thus, in this commentary we now discuss the pro's and con's of different study types, even irrespective of transfusion medicine.

Effect of atorvastatin on progression of sensorineural hearing loss and tinnitus in the elderly: results of a prospective, randomized, double-blind clinical trial.

PubMed

Olzowy, Bernhard; Canis, Martin; Hempel, John-Martin; Mazurek, Birgit; Suckfüll, Markus

2007-06-01

To test whether the 3-hydroxy-3-methylglutaryl- coenzyme A reductase inhibitor atorvastatin can slow down the progression of presbycusis. Fifty patients 60- to 75-years-old with presbycusis and moderately elevated serum cholesterol. In a double-blind design, patients were randomly assigned to treatment with either atorvastatin (40 mg/d orally) or placebo. Pure-tone audiometry and tinnitus evaluation at enrolment and after 7 and 13 months. Development of hearing thresholds after 7 and 13 months showed no significant differences between the groups. Tinnitus score continuously improved in the atorvastatin group (34.8 at 7 and 27.6 at 13 mo), whereas it slightly deteriorated in the placebo group (24.8 at 7 and 26.8 at 13 mo). The effect on tinnitus was a tendency without statistic significance (p = 0.0833). Atorvastatin had no effect on the development of hearing thresholds, but resulted in a trend toward a relief of tinnitus.

A double-blind randomized placebo-controlled feasibility study evaluating individualized homeopathy in managing pain of knee osteoarthritis.

PubMed

Koley, Munmun; Saha, Subhranil; Ghosh, Shubhamoy

2015-07-01

Few homeopathic complexes seemed to produce significant effects in osteoarthritis; still, individualized homeopathy remained untested. We evaluated the feasibility of conducting an efficacy trial of individualized homeopathy in osteoarthritis. A prospective, parallel-arm, double-blind, randomized, placebo-controlled pilot study was conducted from January to October 2014 involving 60 patients (homeopathy, n = 30; placebo, n = 30) who were suffering from acute painful episodes of knee osteoarthritis and visiting the outpatient clinic of Mahesh Bhattacharyya Homeopathic Medical College and Hospital, West Bengal, India. Statistically significant reduction was achieved in 3 visual analog scales (measuring pain, stiffness, and loss of function) and Osteoarthritis Research Society International scores in both groups over 2 weeks (P < .05); however, group differences were not significant (P > .05). Overall, homeopathy did not appear to be superior to placebo; still, further rigorous evaluation in this design involving a larger sample size seems feasible in future. Clinical Trials Registry, India (CTRI/2014/05/004589). © The Author(s) 2015.

To stage or not to stage? That is the question: (with apologies to Shakespeare).

PubMed

Kitchener, Henry C

2010-10-01

The International Federation of Gynecology and Obstetrics staging rules for endometrial cancer require pelvic and para-aortic node dissection to define the extent of disease. Retrospective studies have reported improved survival in women who underwent lymphadenectomy compared with those who did not. This association may not be causally related because of bias. Recently reported prospective randomized trials of pelvic lymphadenectomy have failed to demonstrate a survival benefit. Critics of these trials remain skeptical because of perceived limitations in design, particularly the inclusion of non-high-risk women and the lack of full para-aortic lymphadenectomy. Until new trial evidence is produced to the contrary, routine lymphadenectomy cannot be recommended for endometrial cancer.

Cluster-randomized Studies in Educational Research: Principles and Methodological Aspects.

PubMed

Dreyhaupt, Jens; Mayer, Benjamin; Keis, Oliver; Öchsner, Wolfgang; Muche, Rainer

2017-01-01

An increasing number of studies are being performed in educational research to evaluate new teaching methods and approaches. These studies could be performed more efficiently and deliver more convincing results if they more strictly applied and complied with recognized standards of scientific studies. Such an approach could substantially increase the quality in particular of prospective, two-arm (intervention) studies that aim to compare two different teaching methods. A key standard in such studies is randomization, which can minimize systematic bias in study findings; such bias may result if the two study arms are not structurally equivalent. If possible, educational research studies should also achieve this standard, although this is not yet generally the case. Some difficulties and concerns exist, particularly regarding organizational and methodological aspects. An important point to consider in educational research studies is that usually individuals cannot be randomized, because of the teaching situation, and instead whole groups have to be randomized (so-called "cluster randomization"). Compared with studies with individual randomization, studies with cluster randomization normally require (significantly) larger sample sizes and more complex methods for calculating sample size. Furthermore, cluster-randomized studies require more complex methods for statistical analysis. The consequence of the above is that a competent expert with respective special knowledge needs to be involved in all phases of cluster-randomized studies. Studies to evaluate new teaching methods need to make greater use of randomization in order to achieve scientifically convincing results. Therefore, in this article we describe the general principles of cluster randomization and how to implement these principles, and we also outline practical aspects of using cluster randomization in prospective, two-arm comparative educational research studies.

Applicability of action planning and coping planning to dental flossing among Norwegian adults: a confirmatory factor analysis approach.

PubMed

Astrøm, Anne Nordrehaug

2008-06-01

Using a prospective design and a representative sample of 25-yr-old Norwegians, this study hypothesized that action planning and coping planning will add to the prediction of flossing at 4 wk of follow-up over and above the effect of intention and previous flossing. This study tested the validity of a proposed 3-factor structure of the measurement model of intention, action planning, and coping planning and for its invariance across gender. A survey was conducted in three Norwegian counties, and 1,509 out of 8,000 randomly selected individuals completed questionnaires assessing the constructs of action planning and coping planning related to daily flossing. A random subsample of 500 participants was followed up at 4 wk with a telephone interview to assess flossing. Confirmatory factor analysis (CFA) confirmed the proposed 3-factor model after respecification. Although the chi-square test was statistically significant [chi(2) = 58.501, degrees of freedom (d.f.) = 17), complementary fit indices were satisfactory [goodness-of-fit index (GFI) = 0.99, root mean squared error of approximation (RMSEA) = 0.04]. Multigroup CFA provided evidence of complete invariance of the measurement model across gender. After controlling for previous flossing, intention (beta = 0.08) and action planning (beta = 0.11) emerged as independent predictors of subsequent flossing, accounting for 2.3% of its variance. Factorial validity of intention, action planning and coping planning, and the validity of action planning in predicting flossing prospectively, was confirmed by the present study.

Prospective evaluation of oral gastrografin(®) in the management of postoperative adhesive small bowel obstruction.

PubMed

Rahmani, Nasrin; Mohammadpour, Reza Ali; Khoshnood, Peyman; Ahmadi, Amirhossein; Assadpour, Sara

2013-06-01

Oral Gastrografin®, a hyperosmolar water-soluble contrast medium, may have a therapeutic effect in adhesive small bowel obstruction. However, findings are still conflicting, as some authors did not find a therapeutic advantage. So, this prospective, randomized, and clinical trial study was designed to determine the value of Gastrografin in adhesive small bowel obstruction. The primary end points were the evaluation of the operative rate reduction and shortening the hospital stay after the use of Gastrografin. A total of 84 patients were randomized into two groups: the control group received conventional treatment, whereas the study group received in addition of 100 mL Gastrografin meal. Patients were followed up within 4 days after admission, and clinical and radiological (if needed) improvements were evaluated. Although the results showed that Gastrografin can decrease the need for surgical management by 14.5 %, no statistically significant differences were observed between the two groups (P = 0.07). Nevertheless, the length of hospital stay revealed a significant reduction from 4.67 ± 1.18 days to 2.69 ± 1.02 days (P = 0.00). The use of Gastrografin in adhesive small bowel obstruction is safe and reduces the length of hospital stay. As a result, the cost of hospital bed occupancy is reduced. Hence, if there was no indication of emergency surgery, administration of oral Gastrografin as a nonoperative treatment in adhesive small bowel obstruction is also recommended.

The Relationship between Emotional Intelligence and Problem Solving Skills in Prospective Teachers

ERIC Educational Resources Information Center

Deniz, Sabahattin

2013-01-01

This study aims to investigate the relationship between emotional intelligence and problem solving. The sample set of the research was taken from the Faculty of Education of Mugla University by the random sampling method. The participants were 386 students--prospective teachers--(224 females; 182 males) who took part in the study voluntarily.…

Investigating Teacher Candidates' Beliefs about Standardized Testing

ERIC Educational Resources Information Center

Kinay, Ismail; Ardiç, Tuncay

2017-01-01

The purpose of this study is to examine the beliefs of prospective teachers' about standardized testing in terms of some variables. This piece of research is in survey model. The study is carried out with 442 randomly selected prospective teachers registered in different departments at Dicle University in Turkey during the 2015-2016 academic year.…

The Tension of Elite "vs". Massified Higher Education Systems: How Prospective Students Perceive Public and Private Universities in Kenya

ERIC Educational Resources Information Center

Oketch, Moses O.

2009-01-01

This article examines how recent changes, leading to a diversified supply in Kenya's university education system, is reflected in prospective students' aspirations, perceptions and preferences to undertake university education. The results, based on a combination of a convenience and snowball sampling of settings, within which random samples of…

Design of hybrid two-dimensional and three-dimensional nanostructured arrays for electronic and sensing applications

NASA Astrophysics Data System (ADS)

Ko, Hyunhyub

This dissertation presents the design of organic/inorganic hybrid 2D and 3D nanostructured arrays via controlled assembly of nanoscale building blocks. Two representative nanoscale building blocks such as carbon nanotubes (one-dimension) and metal nanoparticles (zero-dimension) are the core materials for the study of solution-based assembly of nanostructured arrays. The electrical, mechanical, and optical properties of the assembled nanostructure arrays have been investigated for future device applications. We successfully demonstrated the prospective use of assembled nanostructure arrays for electronic and sensing applications by designing flexible carbon nanotube nanomembranes as mechanical sensors, highly-oriented carbon nanotubes arrays for thin-film transistors, and gold nanoparticle arrays for SERS chemical sensors. In first section, we fabricated highly ordered carbon nanotube (CNT) arrays by tilted drop-casting or dip-coating of CNT solution on silicon substrates functionalized with micropatterned self-assembled monolayers. We further exploited the electronic performance of thin-film transistors based on highly-oriented, densely packed CNT micropatterns and showed that the carrier mobility is largely improved compared to randomly oriented CNTs. The prospective use of Raman-active CNTs for potential mechanical sensors has been investigated by studying the mechano-optical properties of flexible carbon nanotube nanomembranes, which contain freely-suspended carbon nanotube array encapsulated into ultrathin (<50 nm) layer-by-layer (LbL) polymer multilayers. In second section, we fabricated 3D nano-canal arrays of porous alumina membranes decorated with gold nanoparticles for prospective SERS sensors. We showed extraordinary SERS enhancement and suggested that the high performance is associated with the combined effects of Raman-active hot spots of nanoparticle aggregates and the optical waveguide properties of nano-canals. We demonstrated the ability of this SERS substrate for trace level sensing of nitroaromatic explosives by detecting down to 100 zeptogram (˜330 molecules) of DNT.

Meta-analysis of dietary essential fatty acids and long-chain polyunsaturated fatty acids as they relate to visual resolution acuity in healthy preterm infants.

PubMed

SanGiovanni, J P; Parra-Cabrera, S; Colditz, G A; Berkey, C S; Dwyer, J T

2000-06-01

To derive combined estimates of visual resolution acuity differences between healthy preterm infants consuming different compositions and ratios of essential fatty acids (EFAs) and docosahexaenoic acid (DHA), an omega-3 (n-3) long-chain polyunsaturated fatty acid (LCPUFA). Electronic biomedical reference database (Medline and Health Star from 1965 to July 1999) searches with index terms omega-3, n-3, infant, vision, acuity, and human. Current review article, monograph, and book chapter bibliography/reference section hand searches. A total of 5 original articles and 4 review chapters were reviewed for details on study design, conduct, and outcome. Four prospective trials of EFA/LCPUFA supplementation were included in these analyses. For behaviorally based outcomes, there were 2 randomized comparisons each at

Evaluating the Effectiveness of an Antimicrobial Stewardship Program on Reducing the Incidence Rate of Healthcare-Associated Clostridium difficile Infection: A Non-Randomized, Stepped Wedge, Single-Site, Observational Study.

PubMed

DiDiodato, Giulio; McArthur, Leslie

2016-01-01

The incidence rate of healthcare-associated Clostridium difficile infection (HA-CDI) is estimated at 1 in 100 patients. Antibiotic exposure is the most consistently reported risk factor for HA-CDI. Strategies to reduce the risk of HA-CDI have focused on reducing antibiotic utilization. Prospective audit and feedback is a commonly used antimicrobial stewardship intervention (ASi). The impact of this ASi on risk of HA-CDI is equivocal. This study examines the effectiveness of a prospective audit and feedback ASi on reducing the risk of HA-CDI. Single-site, 339 bed community-hospital in Barrie, Ontario, Canada. Primary outcome is HA-CDI incidence rate. Daily prospective and audit ASi is the exposure variable. ASi implemented across 6 wards in a non-randomized, stepped wedge design. Criteria for ASi; any intravenous antibiotic use for ≥ 48 hrs, any oral fluoroquinolone or oral second generation cephalosporin use for ≥ 48 hrs, or any antimicrobial use for ≥ 5 days. HA-CDI cases and model covariates were aggregated by ward, year and month starting September 2008 and ending February 2016. Multi-level mixed effect negative binomial regression analysis was used to model the primary outcome, with intercept and slope coefficients for ward-level random effects estimated. Other covariates tested for inclusion in the final model were derived from previously published risk factors. Deviance residuals were used to assess the model's goodness-of-fit. The dataset included 486 observation periods, of which 350 were control periods and 136 were intervention periods. After accounting for all other model covariates, the estimated overall ASi incidence rate ratio (IRR) was 0.48 (95% 0.30, 0.79). The ASi effect was independent of antimicrobial utilization. The ASi did not seem to reduce the risk of Clostridium difficile infection on the surgery wards (IRR 0.87, 95% CI 0.45, 1.69) compared to the medicine wards (IRR 0.42, 95% CI 0.28, 0.63). The ward-level burden of Clostridium difficile as measured by the ward's previous month's total CDI cases (CDI Lag) and the ward's current month's community-associated CDI cases (CA-CDI) was significantly associated with an increased risk of HA-CDI, with the estimated CDI Lag IRR of 1.21 (95% 1.15, 1.28) and the estimated CA-CDI IRR of 1.10 (95% CI 1.01, 1.20). The ward-level random intercept and slope coefficients were not significant. The final model demonstrated good fit. In this study, a daily prospective audit and feedback ASi resulted in a significant reduction in the risk of HA-CDI on the medicine wards, however, this effect was independent of an overall reduction in antibiotic utilization. In addition, the ward-level burden of Clostridium difficile was shown to significantly increase the risk of HA-CDI, reinforcing the importance of the environment as a source of HA-CDI.

The effects of epidural analgesia on the course and outcome of labour.

PubMed

Finster, M; Santos, A C

1998-09-01

The potential effects of epidural analgesia on the progress and outcome of labour have been the subject of lasting controversy. Retrospective reviews indicate that epidurals are associated with longer labours and/or an increase in the incidence of instrumental or operative delivery. Similar results were obtained in non-randomized prospective studies. None of them established a causal relationship, because without randomization the selection bias cannot be ruled out. Other factors, such as premature rupture of membranes and maternal socioeconomic status, may affect the outcome of labour. It was also reported that introduction of the on-demand epidural service did not increase the primary caesarean section rate. The few prospective randomized studies are contradictory and not very reliable owing to small patient populations and high cross-over rates. There is, however, unanimity among the authors regarding the superiority of pain relief provided by epidural blocks over systemically administered opioids.

Design and rationale of the Paliperidone Palmitate Research in Demonstrating Effectiveness (PRIDE) study: a novel comparative trial of once-monthly paliperidone palmitate versus daily oral antipsychotic treatment for delaying time to treatment failure in persons with schizophrenia.

PubMed

Alphs, Larry; Mao, Lian; Rodriguez, Stephen C; Hulihan, Joe; Starr, H Lynn

2014-12-01

Public health considerations require that clinical trials address the complex "real-world" needs of patients with chronic illnesses. This is particularly true for persons with schizophrenia, whose management is frequently complicated by factors such as comorbid substance abuse, homelessness, and contact with the criminal justice system. In addition, barriers to obtaining health care in the United States often prevent successful community reentry and optimal patient management. Further, nonadherence to treatment is common, and this reinforces cycles of relapse and recidivism. Long-acting injectable antipsychotic therapy may facilitate continuity of treatment and support better outcomes, particularly in patients who face these challenges. Clinical trials with classical explanatory designs may not be the best approaches for evaluating these considerations. We describe the design and rationale of a novel trial that combines both explanatory and pragmatic design features and studies persons with schizophrenia who face these challenges. The Paliperidone Palmitate Research in Demonstrating Effectiveness (PRIDE) study is a prospective, open-label, randomized, 15-month study conducted between May 5, 2010, and December 9, 2013, comparing long-acting injectable paliperidone palmitate and oral antipsychotic medications in subjects with schizophrenia (according to DSM-IV criteria). Investigators and subjects had broad flexibility for treatment decision-making, thus making it a model that better reflects real-world practice. The primary end point was time to treatment failure, defined as arrest/incarceration psychiatric hospitalization; suicide; treatment discontinuation or supplementation due to inadequate efficacy, safety, or tolerability; or increased psychiatric services to prevent hospitalization. This end point was adjudicated by a blinded event monitoring board. Patients were followed to the 15-month end point, regardless of whether they were maintained on their initial randomized treatment. This article provides some of the reasoning behind the authors' choices when combining features from both explanatory and pragmatic approaches to this trial's design. The PRIDE study incorporates real-world design features in a novel, prospective, comparative study of long-acting injectable and oral antipsychotics in persons with schizophrenia who have had recent contact with the criminal justice system. Insights provided should help the reader to better understand the need for more real-world approaches for clinical studies and how a broader approach can better aid clinical treatment and public health decision-making. ClinicalTrials.gov identifier: NCT01157351. © Copyright 2014 Physicians Postgraduate Press, Inc.

Spinal Orthoses: The Crucial Role of Comfort on Compliance of Wearing - Monocentric Prospective Pilot Study of Randomized Cross-Over Design.

PubMed

Herget, G W; Patermann, S; Strohm, P C; Zwingmann, J; Eichelberger, P; Südkamp, N P; Hirschmüller, A

2017-01-01

PURPOSE OF THE STUDY Various spine disorders are regularly treated by orthoses, and success of treatment depends on wearing these devices. In this study we examined the compliance, wear comfort, subjective stabilization and side effects associated with spinal orthoses using an individualized questionnaire and the Compact Short Form-12 Health Survey (SF-12). MATERIAL AND METHODS In this prospective pilot study of randomized cross-over design, twelve healthy volunteers with a mean age of 31.2 years wore three different types of orthoses, each for one week: A hyperextension brace (HB), a custom-made semirigid orthosis (SO) and a custom-made rigid orthosis (RO). The daily duration of wearing the orthosis was defined as primary endpoint; contentment was measured using an individualized questionnaire and the standardized SF-12. RESULTS In the study population calculated probability of wearing the HB and RO was between 0.2 und 38.5% (95% confidence interval). No volunteer wore the SO orthosis for the predefined time. The SO and RO each displayed high subjective stabilization, while the RO was more often associated with side effects like skin pressure marks than the SO. The need for rework due to discomfort was mainly necessary with the RO. We observed no substantial differences in feeling compression and sweating. Noteworthy, eight of 12 subjects complained of uncomfortable sternal pressure due to the upper pad of the HB. The SF-12: scores ranged from 52.1 to 48.6 on the physical (PCS), and from 53.7 to 50.8 on the mental component score (MCS), demonstrating an influence on QoL. DISCUSSION AND CONCLUSIONS The design as well as the orthosis itself influence the compliance of wearing and exert a moderate negative, but acceptable impact on QoL. The SO appeared to correlate with the best overall compromise between comfort and subjective stabilization. Further investigations are necessary in patients with spinal diseases, for whom the effect of orthosis wearing may surpass the potential discomfort. Key words: thoracolumbar spine, orthoses, SF-12 - Quality of Life - QoL, comfort, compliance.

Design and rationale for the Influenza vaccination After Myocardial Infarction (IAMI) trial. A registry-based randomized clinical trial.

PubMed

Fröbert, Ole; Götberg, Matthias; Angerås, Oskar; Jonasson, Lena; Erlinge, David; Engstrøm, Thomas; Persson, Jonas; Jensen, Svend E; Omerovic, Elmir; James, Stefan K; Lagerqvist, Bo; Nilsson, Johan; Kåregren, Amra; Moer, Rasmus; Yang, Cao; Agus, David B; Erglis, Andrejs; Jensen, Lisette O; Jakobsen, Lars; Christiansen, Evald H; Pernow, John

2017-07-01

Registry studies and case-control studies have demonstrated that the risk of acute myocardial infarction (AMI) is increased following influenza infection. Small randomized trials, underpowered for clinical end points, indicate that future cardiovascular events can be reduced following influenza vaccination in patients with established cardiovascular disease. Influenza vaccination is recommended by international guidelines for patients with cardiovascular disease, but uptake is varying and vaccination is rarely prioritized during hospitalization for AMI. The Influenza vaccination After Myocardial Infarction (IAMI) trial is a double-blind, multicenter, prospective, registry-based, randomized, placebo-controlled, clinical trial. A total of 4,400 patients with ST-segment elevation myocardial infarction (STEMI) or non-STEMI undergoing coronary angiography will randomly be assigned either to in-hospital influenza vaccination or to placebo. Baseline information is collected from national heart disease registries, and follow-up will be performed using both registries and a structured telephone interview. The primary end point is a composite of time to all-cause death, a new AMI, or stent thrombosis at 1 year. The IAMI trial is the largest randomized trial to date to evaluate the effect of in-hospital influenza vaccination on death and cardiovascular outcomes in patients with STEMI or non-STEMI. The trial is expected to provide highly relevant clinical data on the efficacy of influenza vaccine as secondary prevention after AMI. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

Successful Completion of the Pilot Phase of a Randomized Controlled Trial Comparing Sentinel Lymph Node Biopsy to No Further Axillary Staging in Patients with Clinical T1-T2 N0 Breast Cancer and Normal Axillary Ultrasound

PubMed Central

Cyr, Amy E; Tucker, Natalia; Ademuyiwa, Foluso; Margenthaler, Julie A; Aft, Rebecca L; Eberlein, Timothy J; Appleton, Catherine M; Zoberi, Imran; Thomas, Maria A; Gao, Feng; Gillanders, William E

2016-01-01

Background Axillary surgery is not considered therapeutic in patients with clinical T1-T2 N0 breast cancer. The importance of axillary staging is eroding in an era where tumor biology, as defined by biomarker and gene expression profile, is increasingly important in medical decision making. We hypothesize that axillary ultrasound (AUS) is a noninvasive alternative to sentinel lymph node biopsy (SLNB), and AUS could replace SLNB without compromising patient care. Study Design Patients with clinical T1-T2 N0 breast cancer and normal AUS were eligible for enrollment. Subjects were randomized to no further axillary staging (Arm 1) versus SLNB (Arm 2). Descriptive statistics were used to describe the results of the pilot phase of the randomized controlled trial. Results 68 subjects were enrolled in the pilot phase of the trial (34 subjects in Arm 1, no further staging; 32 subjects in Arm 2, SLNB, and 2 subjects voluntarily withdrew from the trial). The median age was 61 years (range 40-80) in Arm 1 and 59 years (range 31-81) in Arm 2, and there were no significant clinical or pathologic differences between the arms. Median follow-up was 17 months (range 1-32). The negative predictive value (NPV) of AUS for identification of clinically significant axillary disease (> 2.0 mm) was 96.9%. No axillary recurrences have been observed in either arm. Conclusions Successful completion of the pilot phase of the randomized controlled trial confirms the feasibility of the study design, and provides prospective evidence supporting the ability of AUS to exclude clinically significant disease in the axilla. The results provide strong support for a phase 2 randomized controlled trial. PMID:27212005

Prospective Observational Study of Implantable Cardioverter‐Defibrillators in Primary Prevention of Sudden Cardiac Death: Study Design and Cohort Description

PubMed Central

Cheng, Alan; Dalal, Darshan; Butcher, Barbara; Norgard, Sanaz; Zhang, Yiyi; Dickfeld, Timm; Eldadah, Zayd A.; Ellenbogen, Kenneth A.; Guallar, Eliseo; Tomaselli, Gordon F.

2013-01-01

Background Primary‐prevention implantable cardioverter‐defibrillators (ICDs) reduce total mortality in patients with severe left ventricular systolic function. However, only a minority of patients benefit from these devices. We designed the Prospective Observational Study of Implantable Cardioverter‐Defibrillators (PROSE‐ICD) to identify risk factors and enhance our understanding of the biological mechanisms that predispose to arrhythmic death in patients undergoing ICD implantation for primary prevention of sudden death. Methods and Results This is a multicenter prospective cohort study with a target enrollment of 1200 patients. The primary end point is ICD shocks for adjudicated ventricular tachyarrhythmias. The secondary end point is total mortality. All patients undergo a comprehensive evaluation including history and physical examination, signal‐averaged electrocardiograms, and blood sampling for genomic, proteomic, and metabolomic analyses. Patients are evaluated every 6 months and after every known ICD shock for additional electrocardiographic and blood sampling. As of December 2011, a total of 1177 patients have been enrolled with more nonwhite and female patients compared to previous randomized trials. A total of 143 patients have reached the primary end point, whereas a total of 260 patients died over an average follow‐up of 59 months. The PROSE‐ICD study represents a real‐world cohort of individuals with systolic heart failure receiving primary‐prevention ICDs. Conclusions Extensive electrophysiological and structural phenotyping as well as the availability of serial DNA and serum samples will be important resources for evaluating novel metrics for risk stratification and identifying patients at risk for arrhythmic sudden death. Clinical Trial Registration URL: http://clinicaltrials.gov/ Unique Identifier: NCT00733590. PMID:23525420

A cross-sectional analysis of HIV and hepatitis C clinical trials 2007 to 2010: the relationship between industry sponsorship and randomized study design.

PubMed

Goswami, Neela D; Tsalik, Ephraim L; Naggie, Susanna; Miller, William C; Horton, John R; Pfeiffer, Christopher D; Hicks, Charles B

2014-01-22

The proportion of clinical research sponsored by industry will likely continue to expand as federal funds for academic research decreases, particularly in the fields of HIV/AIDS and hepatitis C (HCV). While HIV and HCV continue to burden the US population, insufficient data exists as to how industry sponsorship affects clinical trials involving these infectious diseases. Debate exists about whether pharmaceutical companies undertake more market-driven research practices to promote therapeutics, or instead conduct more rigorous trials than their non-industry counterparts because of increased resources and scrutiny. The ClinicalTrials.gov registry, which allows investigators to fulfill a federal mandate for public trial registration, provides an opportunity for critical evaluation of study designs for industry-sponsored trials, independent of publication status. As part of a large public policy effort, the Clinical Trials Transformation Initiative (CTTI) recently transformed the ClinicalTrials.gov registry into a searchable dataset to facilitate research on clinical trials themselves. We conducted a cross-sectional analysis of 477 HIV and HCV drug treatment trials, registered with ClinicalTrials.gov from 1 October 2007 to 27 September 2010, to study the relationship of study sponsorship with randomized study design. The likelihood of using randomization given industry (versus non-industry) sponsorship was reported with prevalence ratios (PR). PRs were estimated using crude and stratified tabular analysis and Poisson regression adjusting for presence of a data monitoring committee, enrollment size, study phase, number of study sites, inclusion of foreign study sites, exclusion of persons older than age 65, and disease condition. The crude PR was 1.17 (95% CI 0.94, 1.45). Adjusted Poisson models produced a PR of 1.13 (95% CI 0.82, 1.56). There was a trend toward mild effect measure modification by study phase, but this was not statistically significant. In stratified tabular analysis the adjusted PR was 1.14 (95% CI 0.78, 1.68) among phase 2/3 trials and 1.06 (95% CI 0.50, 2.22) among phase 4 trials. No significant relationship was found between industry sponsorship and use of randomization in trial design in this cross-sectional study. Prospective studies evaluating other aspects of trial design may shed further light on the relationship between industry sponsorship and appropriate trial methodology.

A cross-sectional analysis of HIV and hepatitis C clinical trials 2007 to 2010: the relationship between industry sponsorship and randomized study design

PubMed Central

2014-01-01

Background The proportion of clinical research sponsored by industry will likely continue to expand as federal funds for academic research decreases, particularly in the fields of HIV/AIDS and hepatitis C (HCV). While HIV and HCV continue to burden the US population, insufficient data exists as to how industry sponsorship affects clinical trials involving these infectious diseases. Debate exists about whether pharmaceutical companies undertake more market-driven research practices to promote therapeutics, or instead conduct more rigorous trials than their non-industry counterparts because of increased resources and scrutiny. The ClinicalTrials.gov registry, which allows investigators to fulfill a federal mandate for public trial registration, provides an opportunity for critical evaluation of study designs for industry-sponsored trials, independent of publication status. As part of a large public policy effort, the Clinical Trials Transformation Initiative (CTTI) recently transformed the ClinicalTrials.gov registry into a searchable dataset to facilitate research on clinical trials themselves. Methods We conducted a cross-sectional analysis of 477 HIV and HCV drug treatment trials, registered with ClinicalTrials.gov from 1 October 2007 to 27 September 2010, to study the relationship of study sponsorship with randomized study design. The likelihood of using randomization given industry (versus non-industry) sponsorship was reported with prevalence ratios (PR). PRs were estimated using crude and stratified tabular analysis and Poisson regression adjusting for presence of a data monitoring committee, enrollment size, study phase, number of study sites, inclusion of foreign study sites, exclusion of persons older than age 65, and disease condition. Results The crude PR was 1.17 (95% CI 0.94, 1.45). Adjusted Poisson models produced a PR of 1.13 (95% CI 0.82, 1.56). There was a trend toward mild effect measure modification by study phase, but this was not statistically significant. In stratified tabular analysis the adjusted PR was 1.14 (95% CI 0.78, 1.68) among phase 2/3 trials and 1.06 (95% CI 0.50, 2.22) among phase 4 trials. Conclusions No significant relationship was found between industry sponsorship and use of randomization in trial design in this cross-sectional study. Prospective studies evaluating other aspects of trial design may shed further light on the relationship between industry sponsorship and appropriate trial methodology. PMID:24450313

Cluster-randomized Studies in Educational Research: Principles and Methodological Aspects

PubMed Central

Dreyhaupt, Jens; Mayer, Benjamin; Keis, Oliver; Öchsner, Wolfgang; Muche, Rainer

2017-01-01

An increasing number of studies are being performed in educational research to evaluate new teaching methods and approaches. These studies could be performed more efficiently and deliver more convincing results if they more strictly applied and complied with recognized standards of scientific studies. Such an approach could substantially increase the quality in particular of prospective, two-arm (intervention) studies that aim to compare two different teaching methods. A key standard in such studies is randomization, which can minimize systematic bias in study findings; such bias may result if the two study arms are not structurally equivalent. If possible, educational research studies should also achieve this standard, although this is not yet generally the case. Some difficulties and concerns exist, particularly regarding organizational and methodological aspects. An important point to consider in educational research studies is that usually individuals cannot be randomized, because of the teaching situation, and instead whole groups have to be randomized (so-called “cluster randomization”). Compared with studies with individual randomization, studies with cluster randomization normally require (significantly) larger sample sizes and more complex methods for calculating sample size. Furthermore, cluster-randomized studies require more complex methods for statistical analysis. The consequence of the above is that a competent expert with respective special knowledge needs to be involved in all phases of cluster-randomized studies. Studies to evaluate new teaching methods need to make greater use of randomization in order to achieve scientifically convincing results. Therefore, in this article we describe the general principles of cluster randomization and how to implement these principles, and we also outline practical aspects of using cluster randomization in prospective, two-arm comparative educational research studies. PMID:28584874

Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur.

PubMed

Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Etén-Bergqvist, Christina; Persson, Jan

2011-07-01

The aim of this prospective randomized multicenter study was to compare TVT (tension-free vaginal tape) with TVT-Secur in terms of efficacy and safety. We set out to enrol 280 stress incontinent women with a half time interim analysis of short-term cure and a continuous registration of adverse events. Of 133 randomized women, 126 were operated and 123 (TVT n = 62, TVT-Secur n = 61) available for 2 months follow-up. No significant differences were found between groups regarding demographics or grade of incontinence. At 2 months follow-up, subjective cure rate following TVT-Secur was significantly lower than for TVT (72% and 92%, respectively, p = 0.01). Three major complications occurred in the TVT-Secur group: tape erosion into the urethra, a tape inadvertently placed inside the bladder, and an immediate postoperative bleeding from the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding perioperative bleeding, hospital stay, urge symptoms, or postoperative urinary tract infections. Median time for surgery was 13 and 22 min for TVT-Secur and TVT, respectively (p < 0.0001). In a prospective randomized controlled study, the TVT-Secur procedure had a significantly lower subjective cure rate than the retropubic TVT procedure. Due to this, in addition to three serious complications in the TVT-Secur group, we decided to stop further enrolment after the interim analysis. We discourage from further use of the TVT-Secur.

Neuronal effects of nicotine during auditory selective attention.

PubMed

Smucny, Jason; Olincy, Ann; Eichman, Lindsay S; Tregellas, Jason R

2015-06-01

Although the attention-enhancing effects of nicotine have been behaviorally and neurophysiologically well-documented, its localized functional effects during selective attention are poorly understood. In this study, we examined the neuronal effects of nicotine during auditory selective attention in healthy human nonsmokers. We hypothesized to observe significant effects of nicotine in attention-associated brain areas, driven by nicotine-induced increases in activity as a function of increasing task demands. A single-blind, prospective, randomized crossover design was used to examine neuronal response associated with a go/no-go task after 7 mg nicotine or placebo patch administration in 20 individuals who underwent functional magnetic resonance imaging at 3T. The task design included two levels of difficulty (ordered vs. random stimuli) and two levels of auditory distraction (silence vs. noise). Significant treatment × difficulty × distraction interaction effects on neuronal response were observed in the hippocampus, ventral parietal cortex, and anterior cingulate. In contrast to our hypothesis, U and inverted U-shaped dependencies were observed between the effects of nicotine on response and task demands, depending on the brain area. These results suggest that nicotine may differentially affect neuronal response depending on task conditions. These results have important theoretical implications for understanding how cholinergic tone may influence the neurobiology of selective attention.

Rationale and design of the EPISTEME trial: efficacy of post-stroke intensive rosuvastatin treatment for aortogenic embolic stroke.

PubMed

Ueno, Yuji; Yamashiro, Kazuo; Tanaka, Yasutaka; Watanabe, Masao; Shimada, Yoshiaki; Kuroki, Takuma; Miyamoto, Nobukazu; Daimon, Masao; Tanaka, Ryota; Miyauchi, Katsumi; Daida, Hiroyuki; Hattori, Nobutaka; Urabe, Takao

2014-02-01

Large atheromatous aortic plaques (AAPs) are associated with stroke recurrence. Rosuvastatin is a potent lipid-lowering agent and suppresses carotid and coronary artery atherosclerosis. It is unclear whether rosuvastatin has anti-atherogenic effects against AAPs in stroke patients. We designed a clinical trial in stroke patients to analyze changes in AAPs after rosuvastatin treatment using repeated transesophageal echocardiography (TEE). This trial is a prospective randomized open label study. Inclusion criteria were patients were ischemic stroke with hypercholesterolemia and AAPs ≥ 4 mm in thickness. The patients are randomly assigned to either a group treated with 5 mg/day rosuvastatin or a control group. Primary endpoint is the changes in volume and composition of AAPs after 6 months using transesophageal echocardiography (TEE). Biochemical findings are analyzed. By using repeated TEE and binary image analysis, we will be able to compare the dynamic changes in plaque composition of AAPs before and after therapy in the two groups. The EPISTEME trial will provide information on the changes in plaque volume and composition achieved by improvement of lipid profiles with rosuvastatin therapy in stroke patients with aortic atherosclerosis. The results of the study may provide evidence for a therapeutic strategy for aortogenic brain embolism. This study is registered with UMIN-CTR (UMIN000010548).

Rationale and design of the IMPACT EU-trial: improve management of heart failure with procalcitonin biomarkers in cardiology (BIC)-18.

PubMed

Möckel, Martin; Slagman, Anna; Vollert, Jörn Ole; Ebmeyer, Stefan; Wiemer, Jan C; Searle, Julia; Giannitsis, Evangelos; Kellum, John A; Maisel, Alan

2018-02-01

To evaluate the effectiveness of procalcitonin (PCT)-guided antibiotic treatment compared to current treatment practice to reduce 90-day all-cause mortality in emergency patients with shortness of breath (SOB) and suspected acute heart failure (AHF). Concomitant AHF and lower respiratory tract (or other bacterial) infection in emergency patients with dyspnea are common and can be difficult to diagnose. Early and adequate initiation of antibiotic therapy (ABX) significantly improves patient outcome, but superfluous prescription of ABX maybe harmful. In a multicentre, prospective, randomized, controlled process trial with an open intervention, adult emergency patients with SOB and increased levels of natriuretic peptides will be randomized to either a standard care group or a PCT-guided group with respect to the initiation of antibiotic treatment. In the PCT-guided group, the initiation of antibiotic therapy is based on the results of acute PCT measurements at admission, using a cut-off of 0.2 ng/ml. A two-stage sample-size adaptive design is used; an interim analysis was done after completion of 50% of patients and the final sample size remained unchanged. Primary endpoint is 90-day all-cause mortality. The current study will provide evidence, whether the routine use of PCT in patients with suspected AHF improves outcome.

Pain and efficacy rating of a microprocessor-controlled metered injection system for local anaesthesia in minor hand surgery.

PubMed

Nimigan, André S; Gan, Bing Siang

2011-01-01

Purpose. Little attention has been given to syringe design and local anaesthetic administration methods. A microprocessor-controlled anaesthetic delivery device has become available that may minimize discomfort during injection. The purpose of this study was to document the pain experience associated with the use of this system and to compare it with use of a conventional syringe. Methods. A prospective, randomized clinical trial was designed. 40 patients undergoing carpal tunnel release were block randomized according to sex into a two groups: a traditional syringe group and a microprocessor-controlled device group. The primary outcome measure was surgical pain and local anaesthetic administration pain. Secondary outcomes included volume of anaesthetic used and injection time. Results. Analysis showed that equivalent anaesthesia was achieved in the microprocessor-controlled group despite using a significantly lower volume of local anaesthetic (P = .0002). This same group, however, has significantly longer injection times (P < .0001). Pain during the injection process or during surgery was not different between the two groups. Conclusions. This RCT comparing traditional and microprocessor controlled methods of administering local anaesthetic showed similar levels of discomfort in both groups. While the microprocessor-controlled group used less volume, the total time for the administration was significantly greater.

Treatment of Chronic Plantar Fasciitis with Noninvasive Interactive Neurostimulation: A Prospective Randomized Controlled Study.

PubMed

Razzano, Cristina; Carbone, Stefano; Mangone, Massimiliano; Iannotta, M Raffaella; Battaglia, Alessandro; Santilli, Valter

The initial treatment of plantar fasciitis should be conservative, with most cases responding to standard physiotherapy, nonsteroidal anti-inflammatory drugs (NSAIDs), heel pads, and stretching. In cases of chronic refractory symptoms, more invasive treatment could be necessary. Noninvasive interactive neurostimulation (NIN) is a form of electric therapy that works by locating areas of lower skin impedance. The objective of the present prospective randomized controlled study was to evaluate whether the use of NIN for chronic plantar fasciitis could result in greater improvement in a foot functional score, lower levels of reported pain, reduced patient consumption of NSAIDs, and greater patient satisfaction compared with electric shockwave therapy in patients without a response to standard conservative treatment. The patients were randomized using random blocks to the NIN program (group 1) or electric shockwave therapy (group 2). The outcome measurements were the pain subscale of the validated Foot Function Index (PS-FFI), patient-reported subjective assessment of the level of pain using a standard visual analog scale, and daily intake of NSAID tablets (etoricoxib 60 mg). The study group was evaluated at baseline (time 0), week 4 (time 1), and week 12 (final follow-up point). Group 1 (55 patients) experienced significantly better results compared with group 2 (49 patients) in term of the PS-FFI score, visual analog scale score, and daily intake of etoricoxib 60 mg. NIN was an effective treatment of chronic resistant plantar fasciitis, with full patient satisfaction in >90% of cases. The present prospective randomized controlled study showed superior results for noninvasive neurostimulation compared with electric shockwave therapy, in terms of the functional score, pain improvement, and use of NSAIDs. Copyright © 2017 American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.

Involved-Field Radiotherapy versus Elective Nodal Irradiation in Combination with Concurrent Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer: A Prospective Randomized Study

PubMed Central

Chen, Ming; Bao, Yong; Ma, Hong-Lian; Wang, Jin; Wang, Yan; Peng, Fang; Zhou, Qi-Chao; Xie, Cong-Hua

2013-01-01

This prospective randomized study is to evaluate the locoregional failure and its impact on survival by comparing involved field radiotherapy (IFRT) with elective nodal irradiation (ENI) in combination with concurrent chemotherapy for locally advanced non-small cell lung cancer. It appears that higher dose could be delivered in IFRT arm than that in ENI arm, and IFRT did not increase the risk of initially uninvolved or isolated nodal failures. Both a tendency of improved locoregional progression-free survival and a significant increased overall survival rate are in favor of IFRT arm in this study. PMID:23762840

Treatment of lymphangiomas with OK-432 (Picibanil) sclerotherapy: a prospective multi-institutional trial.

PubMed

Giguère, Chantal M; Bauman, Nancy M; Sato, Yutaka; Burke, Diane K; Greinwald, John H; Pransky, Seth; Kelley, Peggy; Georgeson, Keith; Smith, Richard J H

2002-10-01

To describe and to determine the robustness of our study evaluating the efficacy of OK-432 (Picibanil) as a therapeutic modality for lymphangiomas. Prospective, randomized trial and parallel-case series at 13 US tertiary care referral centers. Thirty patients diagnosed as having lymphangioma. Ages in 25 ranged from 6 months to 18 years. Twenty-nine had lesions located in the head-and-neck area. Every patient received a 4-dose injection series of OK-432 scheduled 6 to 8 weeks apart unless a contraindication existed or a complete response was observed before completion of all injections. A control group was observed for 6 months. Successful outcome of therapy was defined as a complete or a substantial (>60%) reduction in lymphangioma size as determined by calculated lesion volumes on computed tomographic or magnetic resonance imaging scans. Overall, 19 (86%) of the 22 patients with predominantly macrocystic lymphangiomas had a successful outcome. OK-432 should be efficacious in the treatment of lymphangiomas. Our study design is well structured to clearly define the role of this treatment agent.

Quantitative comparison of randomization designs in sequential clinical trials based on treatment balance and allocation randomness.

PubMed

Zhao, Wenle; Weng, Yanqiu; Wu, Qi; Palesch, Yuko

2012-01-01

To evaluate the performance of randomization designs under various parameter settings and trial sample sizes, and identify optimal designs with respect to both treatment imbalance and allocation randomness, we evaluate 260 design scenarios from 14 randomization designs under 15 sample sizes range from 10 to 300, using three measures for imbalance and three measures for randomness. The maximum absolute imbalance and the correct guess (CG) probability are selected to assess the trade-off performance of each randomization design. As measured by the maximum absolute imbalance and the CG probability, we found that performances of the 14 randomization designs are located in a closed region with the upper boundary (worst case) given by Efron's biased coin design (BCD) and the lower boundary (best case) from the Soares and Wu's big stick design (BSD). Designs close to the lower boundary provide a smaller imbalance and a higher randomness than designs close to the upper boundary. Our research suggested that optimization of randomization design is possible based on quantified evaluation of imbalance and randomness. Based on the maximum imbalance and CG probability, the BSD, Chen's biased coin design with imbalance tolerance method, and Chen's Ehrenfest urn design perform better than popularly used permuted block design, EBCD, and Wei's urn design. Copyright © 2011 John Wiley & Sons, Ltd.

Association between Adult Height and Risk of Colorectal, Lung, and Prostate Cancer: Results from Meta-analyses of Prospective Studies and Mendelian Randomization Analyses

PubMed Central

Khankari, Nikhil K.; Shu, Xiao-Ou; Wen, Wanqing; Kraft, Peter; Lindström, Sara; Peters, Ulrike; Schildkraut, Joellen; Schumacher, Fredrick; Bofetta, Paolo; Risch, Angela; Bickeböller, Heike; Amos, Christopher I.; Easton, Douglas; Gruber, Stephen B.; Haiman, Christopher A.; Hunter, David J.; Chanock, Stephen J.; Pierce, Brandon L.; Zheng, Wei

2016-01-01

Background Observational studies examining associations between adult height and risk of colorectal, prostate, and lung cancers have generated mixed results. We conducted meta-analyses using data from prospective cohort studies and further carried out Mendelian randomization analyses, using height-associated genetic variants identified in a genome-wide association study (GWAS), to evaluate the association of adult height with these cancers. Methods and Findings A systematic review of prospective studies was conducted using the PubMed, Embase, and Web of Science databases. Using meta-analyses, results obtained from 62 studies were summarized for the association of a 10-cm increase in height with cancer risk. Mendelian randomization analyses were conducted using summary statistics obtained for 423 genetic variants identified from a recent GWAS of adult height and from a cancer genetics consortium study of multiple cancers that included 47,800 cases and 81,353 controls. For a 10-cm increase in height, the summary relative risks derived from the meta-analyses of prospective studies were 1.12 (95% CI 1.10, 1.15), 1.07 (95% CI 1.05, 1.10), and 1.06 (95% CI 1.02, 1.11) for colorectal, prostate, and lung cancers, respectively. Mendelian randomization analyses showed increased risks of colorectal (odds ratio [OR] = 1.58, 95% CI 1.14, 2.18) and lung cancer (OR = 1.10, 95% CI 1.00, 1.22) associated with each 10-cm increase in genetically predicted height. No association was observed for prostate cancer (OR = 1.03, 95% CI 0.92, 1.15). Our meta-analysis was limited to published studies. The sample size for the Mendelian randomization analysis of colorectal cancer was relatively small, thus affecting the precision of the point estimate. Conclusions Our study provides evidence for a potential causal association of adult height with the risk of colorectal and lung cancers and suggests that certain genetic factors and biological pathways affecting adult height may also affect the risk of these cancers. PMID:27598322

Prospective memory: effects of divided attention on spontaneous retrieval.

PubMed

Harrison, Tyler L; Mullet, Hillary G; Whiffen, Katie N; Ousterhout, Hunter; Einstein, Gilles O

2014-02-01

We examined the effects of divided attention on the spontaneous retrieval of a prospective memory intention. Participants performed an ongoing lexical decision task with an embedded prospective memory demand, and also performed a divided-attention task during some segments of lexical decision trials. In all experiments, monitoring was highly discouraged, and we observed no evidence that participants engaged monitoring processes. In Experiment 1, performing a moderately demanding divided-attention task (a digit detection task) did not affect prospective memory performance. In Experiment 2, performing a more challenging divided-attention task (random number generation) impaired prospective memory. Experiment 3 showed that this impairment was eliminated when the prospective memory cue was perceptually salient. Taken together, the results indicate that spontaneous retrieval is not automatic and that challenging divided-attention tasks interfere with spontaneous retrieval and not with the execution of a retrieved intention.

Treatment of pregnancy-related pelvic girdle and/or low back pain after delivery design of a randomized clinical trial within a comprehensive prognostic cohort study [ISRCTN08477490

PubMed Central

Bastiaenen, Caroline HG; de Bie, Rob A; Wolters, Pieter MJC; Vlaeyen, Johan WS; Bastiaanssen, Janneke M; Klabbers, Aldegonda BA; Heuts, Annie; van den Brandt, Piet A; Essed, Gerard GM

2004-01-01

Background Pregnancy-related pelvic girdle and/or low back pain is a controversial syndrome because insight in etiology and prognosis is lacking. The controversy relates to factors eliciting pain and some prognostic factors such as the interpretation of pain at the symphysis. Recent research about treatment strategies also reflects those various opinions, in fact suggesting there is professional uncertainty about the optimal approach. Currently, physiotherapists often prescribe a pain-contingent treatment regime of relative rest and avoiding several day-to-day activities. Additionally, treatment more often includes an exercise program to guide rectification of the muscle imbalance and alignment of the pelvic girdle. Effectiveness of those interventions is not proven and the majority of the studies are methodologically flawed. Investigators draw particular attention to biomedical factors but there is growing evidence that important prognostic issues such as biopsychosocial factors appear to be even more important as point of action in a treatment program. Methods/design This pragmatic randomized controlled trial is designed to evaluate the effectiveness of a tailor-made treatment program with respect to biopsychosocial factors in primary care. The effect of the experimental intervention and usual care are evaluated as they are applied in primary health care. The trial is embedded in a cohort study that is designed as a longitudinal, prospective study, which studies prevalence, etiology, severity and prognosis during pregnancy until one year after delivery. The present paper focuses on choices regarding recruitment procedures, in-/exclusion criteria and the development of a well-timed intervention. Discussion This section briefly discusses the actions taken to minimize bias in the design, the proper time-window for the experimental intervention and the contrast between the experimental intervention and usual care. PMID:15619331

Spine device clinical trials: design and sponsorship.

PubMed

Cher, Daniel J; Capobianco, Robyn A

2015-05-01

Multicenter prospective randomized clinical trials represent the best evidence to support the safety and effectiveness of medical devices. Industry sponsorship of multicenter clinical trials is purported to lead to bias. To determine what proportion of spine device-related trials are industry-sponsored and the effect of industry sponsorship on trial design. Analysis of data from a publicly available clinical trials database. Clinical trials of spine devices registered on ClinicalTrials.gov, a publicly accessible trial database, were evaluated in terms of design, number and location of study centers, and sample size. The relationship between trial design characteristics and study sponsorship was evaluated using logistic regression and general linear models. One thousand six hundred thrity-eight studies were retrieved from ClinicalTrials.gov using the search term "spine." Of the 367 trials that focused on spine surgery, 200 (54.5%) specifically studied devices for spine surgery and 167 (45.5%) focused on other issues related to spine surgery. Compared with nondevice trials, device trials were far more likely to be sponsored by the industry (74% vs. 22.2%, odds ratio (OR) 9.9 [95% confidence interval 6.1-16.3]). Industry-sponsored device trials were more likely multicenter (80% vs. 29%, OR 9.8 [4.8-21.1]) and had approximately four times as many participating study centers (p<.0001) and larger sample sizes. There were very few US-based multicenter randomized trials of spine devices not sponsored by the industry. Most device-related spine research is industry-sponsored. Multicenter trials are more likely to be industry-sponsored. These findings suggest that previously published studies showing larger effect sizes in industry-sponsored vs. nonindustry-sponsored studies may be biased as a result of failure to take into account the marked differences in design and purpose. Copyright © 2015 Elsevier Inc. All rights reserved.

Adaptive adjustment of the randomization ratio using historical control data

PubMed Central

Hobbs, Brian P.; Carlin, Bradley P.; Sargent, Daniel J.

2013-01-01

Background Prospective trial design often occurs in the presence of “acceptable” [1] historical control data. Typically this data is only utilized for treatment comparison in a posteriori retrospective analysis to estimate population-averaged effects in a random-effects meta-analysis. Purpose We propose and investigate an adaptive trial design in the context of an actual randomized controlled colorectal cancer trial. This trial, originally reported by Goldberg et al. [2], succeeded a similar trial reported by Saltz et al. [3], and used a control therapy identical to that tested (and found beneficial) in the Saltz trial. Methods The proposed trial implements an adaptive randomization procedure for allocating patients aimed at balancing total information (concurrent and historical) among the study arms. This is accomplished by assigning more patients to receive the novel therapy in the absence of strong evidence for heterogeneity among the concurrent and historical controls. Allocation probabilities adapt as a function of the effective historical sample size (EHSS) characterizing relative informativeness defined in the context of a piecewise exponential model for evaluating time to disease progression. Commensurate priors [4] are utilized to assess historical and concurrent heterogeneity at interim analyses and to borrow strength from the historical data in the final analysis. The adaptive trial’s frequentist properties are simulated using the actual patient-level historical control data from the Saltz trial and the actual enrollment dates for patients enrolled into the Goldberg trial. Results Assessing concurrent and historical heterogeneity at interim analyses and balancing total information with the adaptive randomization procedure leads to trials that on average assign more new patients to the novel treatment when the historical controls are unbiased or slightly biased compared to the concurrent controls. Large magnitudes of bias lead to approximately equal allocation of patients among the treatment arms. Using the proposed commensurate prior model to borrow strength from the historical data, after balancing total information with the adaptive randomization procedure, provides admissible estimators of the novel treatment effect with desirable bias-variance trade-offs. Limitations Adaptive randomization methods in general are sensitive to population drift and more suitable for trials that initiate with gradual enrollment. Balancing information among study arms in time-to-event analyses is difficult in the presence of informative right-censoring. Conclusions The proposed design could prove important in trials that follow recent evaluations of a control therapy. Efficient use of the historical controls is especially important in contexts where reliance on pre-existing information is unavoidable because the control therapy is exceptionally hazardous, expensive, or the disease is rare. PMID:23690095

Adaptive adjustment of the randomization ratio using historical control data.

PubMed

Hobbs, Brian P; Carlin, Bradley P; Sargent, Daniel J

2013-01-01

Prospective trial design often occurs in the presence of 'acceptable' historical control data. Typically, these data are only utilized for treatment comparison in a posteriori retrospective analysis to estimate population-averaged effects in a random-effects meta-analysis. We propose and investigate an adaptive trial design in the context of an actual randomized controlled colorectal cancer trial. This trial, originally reported by Goldberg et al., succeeded a similar trial reported by Saltz et al., and used a control therapy identical to that tested (and found beneficial) in the Saltz trial. The proposed trial implements an adaptive randomization procedure for allocating patients aimed at balancing total information (concurrent and historical) among the study arms. This is accomplished by assigning more patients to receive the novel therapy in the absence of strong evidence for heterogeneity among the concurrent and historical controls. Allocation probabilities adapt as a function of the effective historical sample size (EHSS), characterizing relative informativeness defined in the context of a piecewise exponential model for evaluating time to disease progression. Commensurate priors are utilized to assess historical and concurrent heterogeneity at interim analyses and to borrow strength from the historical data in the final analysis. The adaptive trial's frequentist properties are simulated using the actual patient-level historical control data from the Saltz trial and the actual enrollment dates for patients enrolled into the Goldberg trial. Assessing concurrent and historical heterogeneity at interim analyses and balancing total information with the adaptive randomization procedure lead to trials that on average assign more new patients to the novel treatment when the historical controls are unbiased or slightly biased compared to the concurrent controls. Large magnitudes of bias lead to approximately equal allocation of patients among the treatment arms. Using the proposed commensurate prior model to borrow strength from the historical data, after balancing total information with the adaptive randomization procedure, provides admissible estimators of the novel treatment effect with desirable bias-variance trade-offs. Adaptive randomization methods in general are sensitive to population drift and more suitable for trials that initiate with gradual enrollment. Balancing information among study arms in time-to-event analyses is difficult in the presence of informative right-censoring. The proposed design could prove important in trials that follow recent evaluations of a control therapy. Efficient use of the historical controls is especially important in contexts where reliance on preexisting information is unavoidable because the control therapy is exceptionally hazardous, expensive, or the disease is rare.

A prospective randomized study of use of drain versus no drain after burr-hole evacuation of chronic subdural hematoma.

PubMed

Singh, Amit Kumar; Suryanarayanan, Bhaskar; Choudhary, Ajay; Prasad, Akhila; Singh, Sachin; Gupta, Laxmi Narayan

2014-01-01

Chronic subdural hematoma (CSDH) recurs after surgical evacuation in 5-30% of patients. Inserting subdural drain might reduce the recurrence rate, but is not commonly practiced. There are few prospective studies to evaluate the effect of subdural drains. A prospective randomized study to investigate the effect of subdural drains in the on recurrence rates and clinical outcome following burr-hole drainage (BHD) of CSDH was undertaken. During the study period, 246 patients with CSDH were assessed for eligibility. Among 200 patients fulfilling the eligibility criteria, 100 each were assigned to "drain group" (drain inserted into the subdural space following BHD) and "without drain group" (subdural drain was not inserted following BHD) using random allocation software. The primary end point was recurrence needing re-drainage up to a period of 6 months from surgery. Recurrence occurred in 9 of 100 patients with a drain, and 26 of 100 patients in without drain group (P = 0.002). The mortality was 5% in patients with drain and 4% in patients without drain group (P = 0.744). The medical and surgical complications were comparable between the two study groups. Use of a subdural drain after burr-hole evacuation of a CSDH reduces the recurrence rate and is not associated with increased complications.

Human herpes viruses in burn patients: A systematic review.

PubMed

Wurzer, Paul; Guillory, Ashley; Parvizi, Daryousch; Clayton, Robert P; Branski, Ludwik K; Kamolz, Lars-P; Finnerty, Celeste C; Herndon, David N; Lee, Jong O

2017-02-01

The contribution of human herpes viruses, including herpes simplex virus (HSV), cytomegalovirus (CMV), and varicella zoster virus (VZV) to morbidity and mortality after burns remains controversial. This systematic review was undertaken to assess evidence of herpes virus-related morbidity and mortality in burns. PubMed, Ovid, and Web of Science were searched to identify studies of HSV, CMV, or VZV infections in burn patients. Exclusion criteria included: A level of evidence (LoE) of IV or V; nonhuman in vivo studies; and non-English articles. There was no limitation by publication date. Fifty articles were subjected to full-text analysis. Of these, 18 had LoE between I-III and were included in the final review (2 LoE I, 16 LoE II-III). Eight had a prospective study design, 9 had a retrospective study design, and 1 included both. No direct evidence linked CMV and HSV infection with increased morbidity and mortality in burns. Following burn, CMV reactivation was more common than a primary CMV infection. Active HSV infection impaired wound healing but was not directly correlated to mortality. Infections with VZV are rare after burns but when they occur, VZV infections were associated with severe complications including mortality. The therapeutic effect of antiviral agents administered after burns warrants investigation via prospective randomized controlled trials. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

Packed red blood cell transfusion is not associated with increased risk of necrotizing enterocolitis in premature infants

PubMed Central

Sharma, R; Kraemer, DF; Torrazza, RM; Mai, V; Neu, J; Shuster, JJ; Hudak, ML

2015-01-01

OBJECTIVE Recent reports have posited a temporal association between blood transfusion with packed red blood cells (BT) and necrotizing enterocolitis (NEC). We evaluated the relationship between BT and NEC among infants at three hospitals who were consented at birth into a prospective observational study of NEC. STUDY DESIGN We used a case–control design to match each case of NEC in our study population of infants born at <33 weeks postmenstrual age (PMA) to one control infant using hospital of birth, PMA, birth weight and date of birth. RESULT The number of transfusions per infant did not differ between 42 NEC cases and their controls (4.0 ± 4.6 vs 5.4 ± 4.1, mean ± s.d., P = 0.063). A matched-pair analysis did not identify an association of transfusion with NEC in either the 48-h or 7-day time periods before the onset of NEC. Stratifying on matched-sets, the Cox proportional hazard model did not identify any difference in the total number of BTs between the two groups (hazard ratio 0.78, 95% confidence interval 0.57 to 1.07, P = 0.11). CONCLUSION In contrast to previous studies, our case–control study did not identify a significant temporal association between BT and NEC. Additional large prospective randomized studies are needed to clarify the relationship between BT and NEC. PMID:25144159

Development and Assessment of Memorial Sloan Kettering Cancer Center’s Surgical Secondary Events Grading System

PubMed Central

Strong, Vivian E.; Selby, Luke V.; Sovel, Mindy; Disa, Joseph J.; Hoskins, William; DeMatteo, Ronald; Scardino, Peter; Jaques, David P.

2015-01-01

Background Studying surgical secondary events is an evolving effort with no current established system for database design, standard reporting, or definitions. Using the Clavien-Dindo classification as a guide, in 2001 we developed a Surgical Secondary Events database based on grade of event and required intervention to begin prospectively recording and analyzing all surgical secondary events (SSE). Study Design Events are prospectively entered into the database by attending surgeons, house staff, and research staff. In 2008 we performed a blinded external audit of 1,498 operations that were randomly selected to examine the quality and reliability of the data. Results 1,498 of 4,284 operations during the 3rd quarter of 2008 were audited. 79% (N=1,180) of the operations did not have a secondary event while 21% (N=318) of operations had an identified event. 91% (1,365) of operations were correctly entered into the SSE database. 97% (129/133) of missed secondary events were Grades I and II. Three Grade III (2%) and one Grade IV (1%) secondary event were missed. There were no missed Grade 5 secondary events. Conclusion Grade III – IV events are more accurately collected than Grade I – II events. Robust and accurate secondary events data can be collected by clinicians and research staff and these data can safely be used for quality improvement projects and research. PMID:25319579

A Study on the Spatial Abilities of Prospective Social Studies Teachers: A Mixed Method Research

ERIC Educational Resources Information Center

Yurt, Eyüp; Tünkler, Vural

2016-01-01

This study investigated prospective social studies teachers' spatial abilities. It was conducted with 234 prospective teachers attending Social Studies Teaching departments at Education Faculties of two universities in Central and Southern Anatolia. This study, designed according to the explanatory-sequential design, is a mixed research method,…

Design of the evolution of management strategies of heart failure patients with implantable defibrillators (EVOLVO) study to assess the ability of remote monitoring to treat and triage patients more effectively

PubMed Central

Marzegalli, Maurizio; Landolina, Maurizio; Lunati, Maurizio; Perego, Giovanni B; Pappone, Alessia; Guenzati, Giuseppe; Campana, Carlo; Frigerio, Maria; Parati, Gianfranco; Curnis, Antonio; Colangelo, Irene; Valsecchi, Sergio

2009-01-01

Background Heart failure patients with implantable defibrillators (ICD) frequently visit the clinic for routine device monitoring. Moreover, in the case of clinical events, such as ICD shocks or alert notifications for changes in cardiac status or safety issues, they often visit the emergency department or the clinic for an unscheduled visit. These planned and unplanned visits place a great burden on healthcare providers. Internet-based remote device interrogation systems, which give physicians remote access to patients' data, are being proposed in order to reduce routine and interim visits and to detect and notify alert conditions earlier. Methods The EVOLVO study is a prospective, randomized, parallel, unblinded, multicenter clinical trial designed to compare remote ICD management with the current standard of care, in order to assess its ability to treat and triage patients more effectively. Two-hundred patients implanted with wireless-transmission-enabled ICD will be enrolled and randomized to receive either the Medtronic CareLink® monitor for remote transmission or the conventional method of in-person evaluations. The purpose of this manuscript is to describe the design of the trial. The results, which are to be presented separately, will characterize healthcare utilizations as a result of ICD follow-up by means of remote monitoring instead of conventional in-person evaluations. Trial registration ClinicalTrials.gov: NCT00873899 PMID:19538734

Prospective Randomized Trial of Use of In-House Prepared Low-Cost Radiopharmaceutical Versus Commercial Radiopharmaceutical for Sentinel Lymph Node Biopsy in Patients with Early Stage Invasive Breast Cancer.

PubMed

Agarwal, Gaurav; Rajan, Sendhil; Mayilvaganan, Sabaretnam; Mishra, Anjali; Krishnani, Narendra; Gambhir, Sanjay

2018-05-01

The current standard-of-care for surgical staging of the axilla in clinically node-negative (N0) early breast cancers is sentinel lymph node biopsy (SLNB), which requires expensive radiopharmaceuticals for efficacious results. In-house produced low-cost radiopharmaceuticals may be the solution and have shown efficacy in earlier observational/pilot studies. We compared SLNB using in-house prepared radiopharmaceutical ( 99m Tc-Antimony-colloid) versus commercially marketed radiopharmaceutical ( 99m Tc-Sulphur-colloid) in this prospective randomized study. 78 clinically N0 early breast cancer patients (T1/2, N0 stages), undergoing primary surgery were prospectively randomized 1:1 into two groups; to receive SLNB using methylene blue, and either 99m Tc-Antimony colloid (Group-1) or   99m Tc-Sulphur colloid (Group-2). Completion axillary dissection was done in all (validation SLNB). SLNB indices were compared between the groups. The groups were comparable with regard to age, stage, tumour size, hormone receptors and HER2neu status. Cost of the in-house prepared 99m Tc-antimony colloid was 16-times lesser compared to 99m Tc-sulphur colloid. SLN identification rates (IR) in Groups 1 and 2 were 100 and 97.4% respectively, (p > 0.05). False negative rates (FNR) in Group 1 and 2 were 6.3% (1/16 patients) and 7.7% (1/13 patients), respectively, (p > 0.05). There were no major allergic reactions in either group. In this prospective randomized trial on early breast cancer patients, accuracy of SLNB was comparable using in-house prepared, 99m Tc-antimony colloid and commercially marketed 99m Tc-sulphur colloid as radiopharmaceutical, while 99m Tc-antimony colloid was much cheaper than 99m Tc-sulphur colloid.

Efficacy of autologous platelet-rich plasma use for orthopaedic indications: a meta-analysis.

PubMed

Sheth, Ujash; Simunovic, Nicole; Klein, Guy; Fu, Freddie; Einhorn, Thomas A; Schemitsch, Emil; Ayeni, Olufemi R; Bhandari, Mohit

2012-02-15

The recent emergence of autologous blood concentrates, such as platelet-rich plasma, as a treatment option for patients with orthopaedic injuries has led to an extensive debate about their clinical benefit. We conducted a systematic review and meta-analysis to determine the efficacy of autologous blood concentrates in decreasing pain and improving healing and function in patients with orthopaedic bone and soft-tissue injuries. We searched MEDLINE and Embase for randomized controlled trials or prospective cohort studies that compared autologous blood concentrates with a control therapy in patients with an orthopaedic injury. We identified additional studies by searching through the bibliographies of eligible studies as well as the archives of orthopaedic conferences and meetings. Twenty-three randomized trials and ten prospective cohort studies were identified. There was a lack of consistency in outcome measures across all studies. In six randomized controlled trials (n = 358) and three prospective cohort studies (n = 88), the authors reported visual analog scale (VAS) scores when comparing platelet-rich plasma with a control therapy across injuries to the acromion, rotator cuff, lateral humeral epicondyle, anterior cruciate ligament, patella, tibia, and spine. The use of platelet-rich plasma provided no significant benefit up to (and including) twenty-four months across the randomized trials (standardized mean difference, -0.34; 95% confidence interval [CI], -0.75 to 0.06) or the prospective cohort studies (standardized mean difference, -0.20; 95% CI, -0.64 to 0.23). Both point estimates suggested a small trend favoring platelet-rich plasma, but the associated wide confidence intervals were consistent with nonsignificant effects. The current literature is complicated by a lack of standardization of study protocols, platelet-separation techniques, and outcome measures. As a result, there is uncertainty about the evidence to support the increasing clinical use of platelet-rich plasma and autologous blood concentrates as a treatment modality for orthopaedic bone and soft-tissue injuries.

Surgical versus Non-Operative Treatment for Lumbar Disc Herniation: Eight-Year Results for the Spine Patient Outcomes Research Trial (SPORT)

PubMed Central

Lurie, Jon D.; Tosteson, Tor D.; Tosteson, Anna N. A.; Zhao, Wenyan; Morgan, Tamara S.; Abdu, William A.; Herkowitz, Harry; Weinstein, James N.

2014-01-01

Study Design Concurrent prospective randomized and observational cohort studies. Objective To assess the 8-year outcomes of surgery vs. non-operative care. Summary of Background Data Although randomized trials have demonstrated small short-term differences in favor of surgery, long-term outcomes comparing surgical to non-operative treatment remain controversial. Methods Surgical candidates with imaging-confirmed lumbar intervertebral disc herniation meeting SPORT eligibility criteria enrolled into prospective randomized (501 participants) and observational cohorts (743 participants) at 13 spine clinics in 11 US states. Interventions were standard open discectomy versus usual non-operative care. Main outcome measures were changes from baseline in the SF-36 Bodily Pain (BP) and Physical Function (PF) scales and the modified Oswestry Disability Index (ODI - AAOS/Modems version) assessed at 6 weeks, 3 and 6 months, and annually thereafter. Results Advantages were seen for surgery in intent-to-treat analyses for the randomized cohort for all primary and secondary outcomes other than work status; however, with extensive non-adherence to treatment assignment (49% patients assigned to non-operative therapy receiving surgery versus 60% of patients assigned to surgery) these observed effects were relatively small and not statistically significant for primary outcomes (BP, PF, ODI). Importantly, the overall comparison of secondary outcomes was significantly greater with surgery in the intent-to-treat analysis (sciatica bothersomeness [p > 0.005], satisfaction with symptoms [p > 0.013], and self-rated improvement [p > 0.013]) in long-term follow-up. An as-treated analysis showed clinically meaningful surgical treatment effects for primary outcome measures (mean change Surgery vs. Non-operative; treatment effect; 95% CI): BP (45.3 vs. 34.4; 10.9; 7.7 to 14); PF (42.2 vs. 31.5; 10.6; 7.7 to 13.5) and ODI (−36.2 vs. −24.8; −11.2; −13.6 to −9.1). Conclusion Carefully selected patients who underwent surgery for a lumbar disc herniation achieved greater improvement than non-operatively treated patients; there was little to no degradation of outcomes in either group (operative and non-operative) from 4 to 8 years. PMID:24153171

Efficacy and safety of a very-low-protein diet when postponing dialysis in the elderly: a prospective randomized multicenter controlled study.

PubMed

Brunori, Giuliano; Viola, Battista F; Parrinello, Giovanni; De Biase, Vincenzo; Como, Giovanna; Franco, Vincenzo; Garibotto, Giacomo; Zubani, Roberto; Cancarini, Giovanni C

2007-05-01

A supplemented very-low-protein diet (sVLPD) seems to be safe when postponing dialysis therapy. Prospective multicenter randomized controlled study designed to assess the noninferiority of diet versus dialysis in 1-year mortality assessed by using intention-to-treat and per-protocol analysis. Italian uremic patients without diabetes older than 70 years with glomerular filtration rate of 5 to 7 mL/min (0.08 to 0.12 mL/s). Randomization to an sVLPD (diet group) or dialysis. The sVLPD is a vegan diet (35 kcal; proteins, 0.3 g/kg body weight daily) supplemented with keto-analogues, amino acids, and vitamins. Patients following an sVLPD started dialysis therapy in the case of malnutrition, intractable fluid overload, hyperkalemia, or appearance of uremic symptoms. Mortality, hospitalization, and metabolic markers. 56 patients were randomly assigned to each group, median follow-up was 26.5 months (interquartile range, 40), and patients in the diet group spent a median of 10.7 months (interquartile range, 11) following an sVLPD. Forty patients in the diet group started dialysis treatment because of either fluid overload or hyperkalemia. There were 31 deaths (55%) in the dialysis group and 28 deaths (50%) in the diet group. One-year observed survival rates at intention to treat were 83.7% (95% confidence interval [CI], 74.5 to 94.0) in the dialysis group versus 87.3% (95% CI, 78.9 to 96.5) in the diet group (log-rank test for noninferiority, P < 0.001; for superiority, P = 0.6): the difference in survival was -3.6% (95% CI, -17 to +10; P = 0.002). The hazard ratio for hospitalization was 1.50 for the dialysis group (95% CI, 1.11 to 2.01; P < 0.01). The unblinded nature of the study, exclusion of patients with diabetes, and incomplete enrollment. An sVLPD was effective and safe when postponing dialysis treatment in elderly patients without diabetes.

A randomized trial of the efficacy and safety of sequential intravenous/oral moxifloxacin monotherapy versus intravenous piperacillin/tazobactam followed by oral amoxicillin/clavulanate for complicated skin and skin structure infections.

PubMed

Gyssens, Inge C; Dryden, Matthew; Kujath, Peter; Nathwani, Dilip; Schaper, Nicolaas; Hampel, Barbara; Reimnitz, Peter; Alder, Jeff; Arvis, Pierre

2011-11-01

The primary aim of the RELIEF study was to evaluate the efficacy and safety of two sequential intravenous (iv)/oral regimens: moxifloxacin iv/oral versus piperacillin/tazobactam (TZP) iv followed by oral amoxicillin/clavulanate (AMC). The study had a prospective, randomized, double-dummy, double-blind, multicentre design. Patients ≥18 years were prospectively stratified according to complicated skin and skin structure infection (cSSSI) subtype/diagnosis (major abscess, diabetic foot infection, wound infection or infected ischaemic ulcer), surgical intervention and severity of illness. Diagnoses and disease severity were based on predetermined criteria, documented by repeated photographs, and confirmed by an independent data review committee. Patients were randomized to receive either 400 mg of moxifloxacin iv once daily followed by 400 mg of moxifloxacin orally once daily or 4.0/0.5 g of TZP iv thrice daily followed by 875/125 mg of AMC orally twice daily for 7-21 days. The primary efficacy variable was clinical response at test of cure (TOC) for the per-protocol (PP) population. Clinical efficacy was assessed by the data review committee based on repeated photographs and case descriptions. Clinical trials registry number: NCT 00402727. A total of 813 patients were randomized. Clinical success rates at TOC were similar for moxifloxacin and TZP-AMC in the PP [320/361 (88.6%) versus 275/307 (89.6%), respectively; P = 0.758] and intent-to-treat (ITT) [350/426 (82.2%) versus 305/377 (80.9%), respectively; P = 0.632] populations. Thus, moxifloxacin was non-inferior to TZP-AMC. Bacteriological success rates were high in both treatment arms [moxifloxacin: 432/497 (86.9%) versus TZP-AMC: 370/429 (86.2%), microbiologically valid (MBV) population]. Moxifloxacin was non-inferior to TZP-AMC at TOC in both the MBV and the ITT populations. Both treatments were well tolerated. Once-daily iv/oral moxifloxacin monotherapy was clinically and bacteriologically non-inferior to iv TZP thrice daily followed by oral AMC twice daily in patients with cSSSIs.

A randomized trial of the efficacy and safety of sequential intravenous/oral moxifloxacin monotherapy versus intravenous piperacillin/tazobactam followed by oral amoxicillin/clavulanate for complicated skin and skin structure infections

PubMed Central

Gyssens, Inge C.; Dryden, Matthew; Kujath, Peter; Nathwani, Dilip; Schaper, Nicolaas; Hampel, Barbara; Reimnitz, Peter; Alder, Jeff; Arvis, Pierre

2011-01-01

Objectives The primary aim of the RELIEF study was to evaluate the efficacy and safety of two sequential intravenous (iv)/oral regimens: moxifloxacin iv/oral versus piperacillin/tazobactam (TZP) iv followed by oral amoxicillin/clavulanate (AMC). Patients and methods The study had a prospective, randomized, double-dummy, double-blind, multicentre design. Patients ≥18 years were prospectively stratified according to complicated skin and skin structure infection (cSSSI) subtype/diagnosis (major abscess, diabetic foot infection, wound infection or infected ischaemic ulcer), surgical intervention and severity of illness. Diagnoses and disease severity were based on predetermined criteria, documented by repeated photographs, and confirmed by an independent data review committee. Patients were randomized to receive either 400 mg of moxifloxacin iv once daily followed by 400 mg of moxifloxacin orally once daily or 4.0/0.5 g of TZP iv thrice daily followed by 875/125 mg of AMC orally twice daily for 7–21 days. The primary efficacy variable was clinical response at test of cure (TOC) for the per-protocol (PP) population. Clinical efficacy was assessed by the data review committee based on repeated photographs and case descriptions. Clinical trials registry number: NCT 00402727. Results A total of 813 patients were randomized. Clinical success rates at TOC were similar for moxifloxacin and TZP–AMC in the PP [320/361 (88.6%) versus 275/307 (89.6%), respectively; P = 0.758] and intent-to-treat (ITT) [350/426 (82.2%) versus 305/377 (80.9%), respectively; P = 0.632] populations. Thus, moxifloxacin was non-inferior to TZP–AMC. Bacteriological success rates were high in both treatment arms [moxifloxacin: 432/497 (86.9%) versus TZP–AMC: 370/429 (86.2%), microbiologically valid (MBV) population]. Moxifloxacin was non-inferior to TZP–AMC at TOC in both the MBV and the ITT populations. Both treatments were well tolerated. Conclusions Once-daily iv/oral moxifloxacin monotherapy was clinically and bacteriologically non-inferior to iv TZP thrice daily followed by oral AMC twice daily in patients with cSSSIs. PMID:21896561

Efficacy and tolerability of two different formulations of atorvastatin in Korean patients with hypercholesterolemia: a multicenter, prospective, randomized clinical trial.

PubMed

Lee, Ju-Hee; Kim, Sang-Hyun; Choi, Dong-Ju; Tahk, Seung-Jea; Yoon, Jung-Han; Choi, Si Wan; Hong, Taek-Jong; Kim, Hyo-Soo

2017-01-01

This study was designed to compare the efficacy and tolerability of the generic formulation (Atorva ® ) and the reference formulation (Lipitor ® ) of atorvastatin, both at a dosage of 20 mg once daily. This study was a prospective open-label, randomized controlled study. Hypercholesterolemic patients who had not achieved low-density lipoprotein (LDL) cholesterol goals according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III) guideline were randomized to generic formulation or reference formulation of atorvastatin. The primary end point was the percent change of blood LDL cholesterol at 8 weeks from the baseline. The secondary end points included the percent changes of total cholesterol, high-density lipoprotein (HDL) cholesterol, triglyceride (TG), apolipoprotein B (ApoB), and apolipoprotein A1 (ApoA1) levels, the percent changes of ApoB/ApoA1 and total cholesterol/HDL cholesterol ratios, and the change in high-sensitivity C-reactive protein (hsCRP) levels. The LDL cholesterol goal achievement rate according to the NCEP-ATP III guideline was also evaluated. Three hundred and seventy-six patients were randomized, and 346 patients (176 in the generic group and 170 in the reference group) completed the study. After the 8 weeks of treatment, LDL cholesterol level was significantly decreased in both the groups, and the decrement was comparable between the two groups (-43.9%±15.3% in the generic group, -43.3%±17.0% in the reference group, P =0.705). The percent changes of total cholesterol, HDL cholesterol, TG, ApoB, ApoA1, ApoB/ApoA1 ratio, total cholesterol/HDL cholesterol ratio, and hsCRP showed insignificant difference between the two groups. However, LDL cholesterol goal achievement rate was significantly higher in the generic group compared to the reference group (90.6% vs 83.0%, P =0.039) in per-protocol analysis. Adverse event rate was comparable between the two groups (12.0% vs 13.7%, P =0.804). The generic formulation of atorvastatin 20 mg was not inferior to the reference formulation of atorvastatin 20 mg in the management of hypercholesterolemia.

Efficacy and tolerability of two different formulations of atorvastatin in Korean patients with hypercholesterolemia: a multicenter, prospective, randomized clinical trial

PubMed Central

Lee, Ju-Hee; Kim, Sang-Hyun; Choi, Dong-Ju; Tahk, Seung-Jea; Yoon, Jung-Han; Choi, Si Wan; Hong, Taek-Jong; Kim, Hyo-Soo

2017-01-01

Purpose This study was designed to compare the efficacy and tolerability of the generic formulation (Atorva®) and the reference formulation (Lipitor®) of atorvastatin, both at a dosage of 20 mg once daily. Methods This study was a prospective open-label, randomized controlled study. Hypercholesterolemic patients who had not achieved low-density lipoprotein (LDL) cholesterol goals according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III) guideline were randomized to generic formulation or reference formulation of atorvastatin. The primary end point was the percent change of blood LDL cholesterol at 8 weeks from the baseline. The secondary end points included the percent changes of total cholesterol, high-density lipoprotein (HDL) cholesterol, triglyceride (TG), apolipoprotein B (ApoB), and apolipoprotein A1 (ApoA1) levels, the percent changes of ApoB/ApoA1 and total cholesterol/HDL cholesterol ratios, and the change in high-sensitivity C-reactive protein (hsCRP) levels. The LDL cholesterol goal achievement rate according to the NCEP-ATP III guideline was also evaluated. Results Three hundred and seventy-six patients were randomized, and 346 patients (176 in the generic group and 170 in the reference group) completed the study. After the 8 weeks of treatment, LDL cholesterol level was significantly decreased in both the groups, and the decrement was comparable between the two groups (−43.9%±15.3% in the generic group, −43.3%±17.0% in the reference group, P=0.705). The percent changes of total cholesterol, HDL cholesterol, TG, ApoB, ApoA1, ApoB/ApoA1 ratio, total cholesterol/HDL cholesterol ratio, and hsCRP showed insignificant difference between the two groups. However, LDL cholesterol goal achievement rate was significantly higher in the generic group compared to the reference group (90.6% vs 83.0%, P=0.039) in per-protocol analysis. Adverse event rate was comparable between the two groups (12.0% vs 13.7%, P=0.804). Conclusion The generic formulation of atorvastatin 20 mg was not inferior to the reference formulation of atorvastatin 20 mg in the management of hypercholesterolemia. PMID:28814835

Study protocol of Prednisone in episodic Cluster Headache (PredCH): a randomized, double-blind, placebo-controlled parallel group trial to evaluate the efficacy and safety of oral prednisone as an add-on therapy in the prophylactic treatment of episodic cluster headache with verapamil

PubMed Central

2013-01-01

Background Episodic cluster headache (ECH) is a primary headache disorder that severely impairs patient’s quality of life. First-line therapy in the initiation of a prophylactic treatment is verapamil. Due to its delayed onset of efficacy and the necessary slow titration of dosage for tolerability reasons prednisone is frequently added by clinicians to the initial prophylactic treatment of a cluster episode. This treatment strategy is thought to effectively reduce the number and intensity of cluster attacks in the beginning of a cluster episode (before verapamil is effective). This study will assess the efficacy and safety of oral prednisone as an add-on therapy to verapamil and compare it to a monotherapy with verapamil in the initial prophylactic treatment of a cluster episode. Methods and design PredCH is a prospective, randomized, double-blind, placebo-controlled trial with parallel study arms. Eligible patients with episodic cluster headache will be randomized to a treatment intervention with prednisone or a placebo arm. The multi-center trial will be conducted in eight German headache clinics that specialize in the treatment of ECH. Discussion PredCH is designed to assess whether oral prednisone added to first-line agent verapamil helps reduce the number and intensity of cluster attacks in the beginning of a cluster episode as compared to monotherapy with verapamil. Trial registration German Clinical Trials Register DRKS00004716 PMID:23889923

Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Current guidelines recommend thrombus aspiration in patients with ST-elevation myocardial infarction (STEMI); however, there are insufficient data to unequivocally support thrombectomy in patients with non-STEMI (NSTEMI). Methods/Design The TATORT-NSTEMI (Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction) trial is a prospective, controlled, multicenter, randomized, open-label trial enrolling 460 patients. The hypothesis is that, against a background of early revascularization, adjunctive thrombectomy leads to less microvascular obstruction (MO) compared with conventional percutaneous coronary intervention (PCI) alone, as assessed by cardiac magnetic resonance imaging (CMR) in patients with NSTEMI. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary endpoint is the extent of late MO assessed by CMR. Secondary endpoints include early MO, infarct size, and myocardial salvage assessed by CMR as well as enzymatic infarct size and angiographic parameters, such as thrombolysis in myocardial infarction flow post-PCI and myocardial blush grade. Furthermore, clinical endpoints including death, myocardial re-infarction, target vessel revascularization, and new congestive heart failure will be recorded at 6 and 12 months. Safety will be assessed by the incidence of bleeding and stroke. Summary The TATORT-NSTEMI trial has been designed to test the hypothesis that thrombectomy will improve myocardial perfusion in patients with NSTEMI and relevant thrombus burden in the culprit vessel reperfused by early PCI. Trial registration The trial is registered under http://www.clinicaltrials.gov: NCT01612312. PMID:23782681

Factors Associated with Use of Automated Smoking Cessation Interventions: Findings from the eQuit Study

ERIC Educational Resources Information Center

Balmford, James; Borland, Ron; Benda, Peter; Howard, Steve

2013-01-01

The aim was to better understand structural factors associated with uptake of automated tailored interventions for smoking cessation. In a prospective randomized controlled trial with interventions only offered, not mandated, participants were randomized based on the following: web-based expert system (QuitCoach); text messaging program (onQ);…

Dual axis operation of a micromachined rate gyroscope

DOE Office of Scientific and Technical Information (OSTI.GOV)

Juneau, T.; Pisano, A.P.; Smith, J.

Since micromachining technology has raised the prospect of fabricating high performance sensors without the associated high cost and large size, many researchers have investigated micromachined rate gyroscopes. The vast majority of research has focused on single input axis rate gyroscopes, but this paper presents work on a dual input axis micromachined rate gyroscope. The key to successful simultaneous dual axis operation is the quad symmetry of the circular oscillating rotor design. Untuned gyroscopes with mismatched modes yielded random walk as low as 10{degrees}/{radical}hour with cross sensitivity ranging from 6% to 16%. Mode frequency matching via electrostatic tuning allowed performance bettermore » than 2{degrees}/{radical}hour, but at the expense of excessive cross sensitivity.« less

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bracken, M.B.

This joint EPRI/National Institutes of Health study is the largest epidemiological study ever undertaken to examine the relationship between exposure to electric and magnetic fields (EMF) during pregnancy and reproductive outcomes. Overall, the study concludes that EMF exposure during pregnancy is unrelated to pregnancy outcome. In specific, the study reveals no association between electromagnetic field exposure from electrically heated beds and intrauterine growth retardation or spontaneous abortion. Among the many strengths of this study are clearly specified hypotheses; prospective design; randomized assignment to exposure monitoring; very large sample size; detailed assessment of potential confounding by known risk factors for adversemore » pregnancy outcomes; and comprehensive statistical analyses. The study also featured extensive exposure assessment, including measurements of EMF from a variety of sources, personal monitoring, and wire coding information.« less

High Mortality without ESCAPE: The Registry of Heart Failure Patients Receiving Pulmonary Artery Catheters without Randomization

PubMed Central

Allen, Larry A.; Rogers, Joseph G.; Warnica, J. Wayne; DiSalvo, Thomas G.; Tasissa, Gudaye; Binanay, Cynthia; O’Connor, Christopher M.; Califf, Robert M.; Leier, Carl V.; Shah, Monica R.; Stevenson, Lynne W.

2008-01-01

Background In ESCAPE, there was no difference in days alive and out of the hospital for patients with decompensated heart failure (HF) randomly assigned to therapy guided by pulmonary artery catheter (PAC) plus clinical assessment versus clinical assessment alone. The external validity of these findings is debated. Methods and Results ESCAPE sites enrolled 439 patients receiving PAC without randomization in a prospective registry. Baseline characteristics, pertinent trial exclusion criteria, reasons for PAC use, hemodynamics, and complications were collected. Survival was determined from the National Death Index and the Alberta Registry. On average, registry patients had lower blood pressure, worse renal function, less neurohormonal antagonist therapy, and higher use of intravenous inotropes as compared with trial patients. Although clinical assessment anticipated less volume overload and greater hypoperfusion among the registry population, measured filling pressures were similarly elevated in the registry and trial, while measured perfusion was slightly higher among registry patients. Registry patients had longer hospitalization (13 vs. 6 days, p <0.001) and higher 6-month mortality (34% vs. 20%, p < 0.001) than trial patients. Conclusions The decision to use PAC without randomization identified a population with higher disease severity and risk of mortality. This prospective registry highlights the complex context of patient selection for randomized trials. PMID:18926438

A Review of Clinical Trials in Spinal Cord Injury including Biomarkers.

PubMed

Badhiwala, Jetan H; Wilson, Jefferson R; Kwon, Brian K; Casha, Steve; Fehlings, Michael G

2018-06-11

Acute traumatic spinal cord injury (SCI) entered the arena of prospective randomized clinical trials almost 40 years ago, with the undertaking of the National Acute Spinal Cord Study (NASCIS) I trial. Since then, a number of clinical trials have been conducted in the field, spurred by the devastating physical, social, and economic consequences of acute SCI for patients, families, and society at large. Many of these have been controversial and attracted criticism. The current review provides a critical summary of select past and current clinical trials in SCI, focusing in particular on the findings of prospective randomized controlled trials (RCTs), the challenges and barriers encountered, and the valuable lessons learned that can be applied to future trials.

Autologous platelet-rich gel for treatment of diabetic chronic refractory cutaneous ulcers: A prospective, randomized clinical trial.

PubMed

Li, Lan; Chen, Dawei; Wang, Chun; Yuan, Nanbing; Wang, Yan; He, Liping; Yang, Yanzhi; Chen, Lihong; Liu, Guanjian; Li, Xiujun; Ran, Xingwu

2015-01-01

The purpose of the study is to examine the safety and effectiveness of topical autologous platelet-rich gel (APG) application on facilitating the healing of diabetic chronic refractory cutaneous ulcers. The study was designed as a prospective, randomized controlled trial between January 1, 2007 and December 31, 2011. Eligible inpatients at the Diabetic Foot Care Center of West China Hospital, Sichuan University (China) were randomly prescribed with a 12-week standard treatment of ulcers (the control group) or standard treatment plus topical application APG (the APG group). The wound healing grades (primary endpoint), time to complete healing, and healing velocity within 12 weeks were monitored as short-term effectiveness measurements, while side effects were documented safety endpoints. The rates of survival and recurrence within the follow up were recorded as long-term effectiveness endpoints. Analysis on total diabetic ulcers (DUs) (n = 117) and subgroup analysis on diabetic foot ulcers (DFUs) (n = 103) were both conducted. Standard treatment plus APG treatment was statistically more effective than standard treatment (p < 0.05 in both total DUs and subgroup of DFUs). The subjects defined as healing grade 1 were 50/59 (84.8%) in total DUs and 41/48 (85.4%) in DFUs in the APG group compared with 40/58 (69.0%) and 37/55 (67.3%) in the control group from intent to treat population. The Kaplan-Meier time-to-healing were significantly different between the two groups (p < 0.05 in both total DUs and subgroup of DFUs). No side effects were identified after topical APG application. The long-term survival and recurrence rates were comparative between groups (p > 0.05). This study shows that topical APG application plus standard treatment is safe and quite effective on diabetic chronic refractory cutaneous ulcers, compared with standard treatment. © 2015 by the Wound Healing Society.

Nonsurgical treatment of peri-implantitis using an air-abrasive device or mechanical debridement and local application of chlorhexidine. Twelve-month follow-up of a prospective, randomized, controlled clinical study.

PubMed

John, Gordon; Sahm, Narja; Becker, Jürgen; Schwarz, Frank

2015-11-01

The purpose of this prospective, parallel group-designed, randomized controlled clinical study was the evaluation of the effectiveness of an air-abrasive device (AAD) for nonsurgical treatment of peri-implantitis. Twenty five patients, showing at least one implant with initial to moderate peri-implantitis, underwent an oral hygiene programme and were randomly treated using either (1) AAD (amino acid glycine powder) or (2) mechanical debridement using carbon curettes and antiseptic therapy with chlorhexidine digluconate (mechanical debridement (MDA)). Clinical parameters were measured at baseline and 12 months after treatment (e.g. bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL)). At 12 months, the AAD group revealed significantly higher (p < 0.05; unpaired t test) decrease in mean BOP scores when compared with MDA-treated sites (41.2 ± 29.5 vs. 16.6 ± 33.4%). Both groups exhibited comparable PD reductions (AAD = 0.5 ± 0.9 mm vs. MDA = 0.4 ± 0.9 mm) and CAL gains (AAD = 0.6 ± 1.3 mm vs. MDA = 0.5 ± 1.1 mm) (p > 0.05; Mann-Whitney test, respectively). Within its limitations, the present study has indicated that both treatment procedures resulted in comparable but limited CAL gains at 12 months. Furthermore, it could be detected that AAD was associated with significantly higher BOP decrease than MDA. The present results have indicated that nonsurgical therapy of peri-implantitis using both AAD and MDA resulted in comparable PD reductions and CAL gains after 12 months of healing. The BOP reductions were significantly higher in the AAD in comparison to the MDA group. So, AAD may be more effective for nonsurgical therapy of peri-implantitis than MDA.

The HYSLAR trial: a prospective randomized controlled trial of the use of a restrictive fluid regimen with 3% hypertonic saline versus lactated Ringers in patients undergoing pancreaticoduodenectomy.

PubMed

Lavu, Harish; Sell, Naomi M; Carter, Timothy I; Winter, Jordan M; Maguire, David P; Gratch, David M; Berman, Richard A; Feil, Marian G; Grunwald, Zvi; Leiby, Benjamin E; Pequignot, Edward C; Rosato, Ernest L; Yeo, Charles J

2014-09-01

This study was designed to determine whether the volume and type of fluid administered for pancreaticoduodenectomy impacts postoperative outcomes. Three percent hypertonic saline (HYS) has been suggested as a means of reducing the volume of fluid required to sustain tissue perfusion in the perioperative period. Between May 2011 and November 2013, patients undergoing pancreaticoduodenectomy were enrolled in an institutional review board-approved, single-center, prospective, parallel, randomized controlled trial (NCT 01428050), comparing lactated Ringers (LAR) (15 mL/kg/hr LAR intraoperation, 2 mL/kg/hr LAR postoperation) with HYS (9 mL/kg/hr LAR and 1 mL/kg/hr HYS intraoperation, 1 mL/kg/hr HYS postoperation). A total of 264 patients were randomized. Demographic variables between groups were similar. The HYS patients had a significantly reduced net fluid balance (65 vs 91 mL/kg, P = 0.02). The overall complication rate was reduced in the HYS group (43% vs 54%), with a relative risk of 0.79 [95% confidence interval (CI), 0.62-1.02; P = 0.073], factoring stratification for pancreas texture. After adjustment for age and weight, the relative risk was 0.75 [95% CI (0.58-0.96); P = 0.023]. The total number of complications was significantly reduced in the HYS group (93 vs 123), with an incidence rate ratio of 0.74 [95% CI (0.56-0.97); P = 0.027]. After adjustment for age and weight, the incidence rate ratio was 0.69 [95% CI (0.52-0.90); P = 0.0068]. Reoperations, length of stay, readmissions, and 90-day mortality were similar between groups. A moderately restrictive fluid regimen with HYS resulted in a statistically significant 25% reduction in complications when adjusted for age, weight, and pancreatic texture.

Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study.

PubMed

Micari, Antonio; Brodmann, Marianne; Keirse, Koen; Peeters, Patrick; Tepe, Gunnar; Frost, Martin; Wang, Hong; Zeller, Thomas

2018-05-28

The IN.PACT Global Study is the largest prospective, multicenter, independently adjudicated trial to evaluate a paclitaxel drug-coated balloon in patients with lifestyle-limiting claudication and/or ischemic rest pain due to atherosclerotic disease of the femoropopliteal artery and includes complex lesions beyond what are typically included in randomized controlled trials. Randomized controlled trials have demonstrated the safety and efficacy of drug-coated balloons for the treatment of Trans-Atlantic Inter-Society Consensus Document II A and B lesions, but there is a need for large-scale prospective studies to evaluate a broader range of lesions. The IN.PACT Global Study enrolled 1,535 subjects, and 1,406 (1,773 lesions) were included in the pre-defined clinical cohort analysis. Freedom from clinically driven target lesion revascularization was evaluated at 24 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically driven target vessel revascularization within 24 months. Mean lesion length was 12.1 cm, 35.5% were total occlusions, and 18.0% had in-stent restenosis. Freedom from clinically driven target lesion revascularization at 24 months was 83.3%, the composite safety endpoint was met in 81.7%, the 2-year all-cause mortality rate was 7.0%, and the major target limb amputation rate was 0.7%. Increased lesion length and the presence of de novo in-stent restenosis or coronary artery disease were associated with increased risk for clinically driven target lesion revascularization by 24 months. This real-world study of femoropopliteal artery disease treatment with drug-coated balloons confirmed positive findings reported from more strictly designed randomized controlled trials and showed that outcomes are durable in this population up to 2 years after treatment. (IN.PACT Global Clinical Study; NCT01609296). Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Transverse vs torsional ultrasound: prospective randomized contralaterally controlled study comparing two phacoemulsification-system handpieces

PubMed Central

Assil, Kerry K; Harris, Lindsay; Cecka, Jeannie

2015-01-01

Purpose To compare surgical efficiency and multiple early clinical outcome variables in eyes undergoing phacoemulsification using either transversal or torsional ultrasound systems. Setting Assil Eye Institute, Beverly Hills, CA, USA. Design Prospective, randomized, clinician-masked, contralaterally controlled single-center evaluation. Patients and methods Patients seeking cataract removal in both eyes with implantation of multifocal intraocular lenses were randomly assigned to one of two treatment rooms for phacoemulsification with either a transverse ultrasound system or torsional handpiece system. The contralateral eye was treated at a later date with the alternate device. A total of 54 eyes of 27 patients having similar degrees of cataract, astigmatism, and visual potential were included. All operative data were collected for analysis, and patients were followed for 3 months after surgery. Results Similar visual acuity was reported at all postoperative visits between the two groups. Mean phacoemulsification time and total power required were both significantly lower with the transverse system than with the torsional technique (P<0.05 for both). Similarly, mean total balanced salt solution used was significantly less with the transverse system vs torsional (P<0.05). Postoperative safety demonstrated significantly lower endothelial cell loss at 1 day and 1 month (P<0.05) with transverse vs torsional. Macular swelling was less at 1 week, 1 month, and 3 months with transverse vs torsional, although the difference did not achieve significance (P=0.1) at any single time point. Clinically detectable corneal edema was reported less frequently at all postoperative time points with the transverse system. Conclusion The transverse ultrasound system was found to be possibly associated with less balanced salt-solution use, less phacoemulsification time, and less power required than the torsional phaco system. Postoperative data suggested that improved phaco efficiency may translate to a better overall safety profile for the patient. PMID:26345628

Study design of the influence of SErotonin inhibition on patients with RENAl impairment or diabetes undergoing drug-eluting stent implantation (SERENADE) study: A multicenter, open-label, prospective, randomized study.

PubMed

Lee, Seung-Ah; Suh, Jung-Won; Park, Jin Joo; Yoon, Chang-Hwan; Cho, Young-Suk; Youn, Tae-Jin; Chae, In-Ho; Kim, Hyo-Soo; Kim, Sang-Hyun; Choi, Dong-Ju

2015-07-01

The rates of stent failure after percutaneous coronary intervention have decreased since the introduction of the drug-eluting stent (DES). However, chronic kidney disease (CKD) and diabetes mellitus (DM) remain strong clinical predictors of poor prognosis despite DES implantation. Sarpogrelate, a selective serotonin (5-hydroxytryptamine (HT)2a [5-HT2A]) receptor antagonist, has antiproliferative effects, reducing neointimal hyperplasia and smooth muscle cell proliferation, as well as potent antiplatelet action, inhibiting 5-HT-induced platelet aggregation. However, efficacy and safety data for sarpogrelate in patients with CKD or DM are limited. We aim to determine whether sarpogrelate has beneficial effects in patients with CDK or DM treated with DES implantation. The SERENADE trial is a multicenter, open-label, prospective, randomized study that will test the superiority of triple anti-platelet therapy (TAT; aspirin, clopidogrel, and sarpogrelate) to conventional dual antiplatelet therapy (DAT; aspirin and clopidogrel) in preventing late lumen loss 9 months after the index procedure in patients with CKD or DM. A total of 220 patients diagnosed with coronary artery disease with DM or CKD will be randomized to the TAT or DAT groups (1:1 ratio) after DES implantation. The primary endpoint is late lumen loss at 9 months assessed by quantitative coronary angiography. Secondary efficacy endpoints are composites of major adverse cardiovascular events including cardiac death, nonfatal myocardial infarction, and target lesion revascularization. Secondary safety endpoints are major bleeding events and hepatic or renal impairment. The SERENADE trial will provide insight on the efficacy of adjunctive therapy with sarpogrelate after DES implantation for patients with high-risk profiles such as CKD or DM. National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov NCT02294643). Copyright © 2015. Published by Elsevier Inc.

The efficacy of hypotonic and near-isotonic saline for parenteral fluid therapy given at low maintenance rate in preventing significant change in plasma sodium in post-operative pediatric patients: protocol for a prospective randomized non-blinded study

PubMed Central

2011-01-01

Background Hyponatremia is the most frequent electrolyte abnormality observed in post-operative pediatric patients receiving intravenous maintenance fluid therapy. If plasma sodium concentration (p-Na+) declines to levels below 125 mmol/L in < 48 h, transient or permanent brain damage may occur. There is an intense debate as to whether the administered volume (full rate vs. restricted rate of infusion) and the composition of solutions used for parenteral maintenance fluid therapy (hypotonic vs. isotonic solutions) contribute to the development of hyponatremia. So far, there is no definitive pediatric data to support a particular choice of parenteral fluid for maintenance therapy in post-surgical patients. Methods/Design Our prospective randomized non-blinded study will be conducted in healthy children and adolescents aged 1 to 14 years who have been operated for acute appendicitis. Patients will be randomized either to intravenous hypotonic (0.23% or 0.40% sodium chloride in glucose, respectively) or near-isotonic (0.81% sodium chloride in glucose) solution given at approximately three-fourths of the average maintenance rate. The main outcome of interest from this study is to evaluate 24 h post-operatively whether differences in p-Na+ between treatment groups are large enough to be of clinical relevance. In addition, water and electrolyte balance as well as regulatory hormones will be measured. Discussion This study will provide valuable information on the efficacy of hypotonic and near-isotonic fluid therapy in preventing a significant decrease in p-Na+. Finally, by means of careful electrolyte and water balance and by measuring regulatory hormones our results will also contribute to a better understanding of the physiopathology of post-operative changes in p-Na+ in a population at risk for hyponatremia. Trial registration The protocol for this study is registered with the current controlled trials registry; registry number: ISRCTN43896775. PMID:21729308

Prevention of endometrial apoptosis: randomized prospective comparison of human chorionic gonadotropin versus progesterone treatment in the luteal phase.

PubMed

Lovely, Laurie P; Fazleabas, Asgerally T; Fritz, Marc A; McAdams, Devin G; Lessey, Bruce A

2005-04-01

To study control of apoptosis in human endometrium, we examined late luteal-phase endometrial biopsies obtained in the late luteal phase for evidence of apoptosis and compared the effects of exogenous human chorionic gonadotropin (hCG) and progesterone on this process. Using a controlled, prospective, and randomized study design, 12 healthy, fertile, reproductive-age women (ages 20-34 yr) with regular menstrual cycles (range, 26-32 d) were recruited. Each underwent an endometrial biopsy 12 d after a urinary LH surge in a control and treatment cycle. After biopsy in a natural cycle, subjects were randomized to receive luteal doses of either 200 mg intravaginal progesterone (d 18-27) or a single im injection of 10,000 IU of hCG (d 19) followed by repeat endometrial biopsy and collection of serum on d 26. Apoptosis was assessed by DNA laddering, localizing apoptotic bodies using immunofluorescent labeling of DNA fragments (the terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling method), and immunohistochemical assessment of apoptosis markers bcl-2, bcl-x, and bax. Serum progesterone levels were compared between treatment groups. Evidence of apoptosis in control cycles was significantly reduced in endometrium after both luteal-phase treatments. The terminal deoxynucleotidyl transferase-mediated dUTP nick-end-labeling results demonstrated significantly less apoptosis in the hCG treatment group compared with controls. Immunostaining for bcl-2 was higher in hCG- and progesterone-treated cycles, whereas bax expression was decreased and bcl-x immunostaining was not different between treatments. Serum progesterone levels were highest in the hCG-treated group, although statistical significance was not reached (P = 0.08). These results demonstrate that signs of apoptosis, already apparent by d 26 of the menstrual cycle can be reduced with either hCG or progesterone treatment. The clinical utility of these findings includes a rational use of luteal-phase support for treatment of women with infertility and/or recurrent pregnancy loss.

Prospective randomized controlled trial comparing standard analgesia with combined intra-operative cystic plate and port-site local anesthesia for post-operative pain management in elective laparoscopic cholecystectomy.

PubMed

Protic, Mladjan; Veljkovic, Radovan; Bilchik, Anton J; Popovic, Ana; Kresoja, Milana; Nissan, Aviram; Avital, Itzhak; Stojadinovic, Alexander

2017-02-01

Various mechanisms, including somatic and visceral nociceptive stimulation, have been suggested as a cause for pain after laparoscopic cholecystectomy (LC). We therefore conducted a prospective randomized controlled trial (PRCT) to evaluate whether somatovisceral pain blockade reduces pain after LC. Analgesic efficacy of multimodal analgesia is superior to standard analgesia for patients undergoing elective LC for symptomatic cholelithiasis. Specifically, topical cystic plate and port-site injection with 0.25 % bupivacaine significantly reduces pain after LC. This study was designed as single-blinded PRCT. This study was conducted in an academic medical center. Between February and May 2010 we randomly assigned 63 patients with symptomatic cholelithiasis in a 1:1 ratio to non-opioid/opioid analgesic combinations (Control Group, n = 32) and non-opioid/opioid analgesic combinations plus topical 0.25 % bupivacaine onto the cystic plate and local 0.25 % bupivacaine port-site injection, post-LC (Study Group, n = 31). Primary endpoint was patient-reported pain 1, 4, 6, 12, 24 h and 1 week post-LC using the Visual Analog Scale (VAS 0-10). Study groups were comparable clinicopathologically. There were no adverse events. A statistically significant reduction in mean pain score was apparent in Study Group patients in comparison with Control Group (mean VAS 4.83 ± 2.33 vs. 6.80 ± 1.87; p < 0.001) at all early (1-6 h) post-operative time points following LC. This PRCT shows significantly improved pain control with somatovisceral pain blockade over non-opioid/opioid analgesic combinations following LC for symptomatic cholelithiasis. For centers not utilizing adjunctive local anesthetic for LC, this topical use of bupivacaine may improve patient comfort during recovery. This trial was registered on www.ClinicalTrials.gov NCT# 01972620.

A Prospective Randomized Study on Operative Treatment for Simple Distal Tibial Fractures-Minimally Invasive Plate Osteosynthesis Versus Minimal Open Reduction and Internal Fixation.

PubMed

Kim, Ji Wan; Kim, Hyun Uk; Oh, Chang-Wug; Kim, Joon-Woo; Park, Ki Chul

2018-01-01

To compare the radiologic and clinical results of minimally invasive plate osteosynthesis (MIPO) and minimal open reduction and internal fixation (ORIF) for simple distal tibial fractures. Randomized prospective study. Three level 1 trauma centers. Fifty-eight patients with simple and distal tibial fractures were randomized into a MIPO group (treatment with MIPO; n = 29) or a minimal group (treatment with minimal ORIF; n = 29). These numbers were designed to define the rate of soft tissue complication; therefore, validation of superiority in union time or determination of differences in rates of delayed union was limited in this study. Simple distal tibial fractures treated with MIPO or minimal ORIF. The clinical outcome measurements included operative time, radiation exposure time, and soft tissue complications. To evaluate a patient's function, the American Orthopedic Foot and Ankle Society ankle score (AOFAS) was used. Radiologic measurements included fracture alignment, delayed union, and union time. All patients acquired bone union without any secondary intervention. The mean union time was 17.4 weeks and 16.3 weeks in the MIPO and minimal groups, respectively. There was 1 case of delayed union and 1 case of superficial infection in each group. The radiation exposure time was shorter in the minimal group than in the MIPO group. Coronal angulation showed a difference between both groups. The American Orthopedic Foot and Ankle Society ankle scores were 86.0 and 86.7 in the MIPO and minimal groups, respectively. Minimal ORIF resulted in similar outcomes, with no increased rate of soft tissue problems compared to MIPO. Both MIPO and minimal ORIF have high union rates and good functional outcomes for simple distal tibial fractures. Minimal ORIF did not result in increased rates of infection and wound dehiscence. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Systematic Review of the Effectiveness of Physical Therapy Modalities in Women With Provoked Vestibulodynia.

PubMed

Morin, Mélanie; Carroll, Marie-Soleil; Bergeron, Sophie

2017-07-01

Pelvic floor muscle physical therapy is recommended in clinical guidelines for women with provoked vestibulodynia (PVD). Including isolated or combined treatment modalities, physical therapy is viewed as an effective first-line intervention, yet no systematic review concerning the effectiveness of physical therapy has been conducted. To systematically appraise the current literature on the effectiveness of physical therapy modalities for decreasing pain during intercourse and improving sexual function in women with PVD. A systematic literature search using PubMed, Scopus, CINHAL, and PEDro was conducted until October 2016. Moreover, a manual search from reference lists of included articles was performed. Ongoing trials also were reviewed using clinicaltrial.gov and ISRCTNregistry. Randomized controlled trials, prospective and retrospective cohorts, and case reports evaluating the effect of isolated or combined physical therapy modalities in women with PVD were included in the review. Main outcome measures were pain during intercourse, sexual function, and patient's perceived improvement. The literature search resulted in 43 eligible studies including 7 randomized controlled trials, 20 prospective studies, 5 retrospective studies, 6 case reports, and 6 study protocols. Most studies had a high risk of bias mainly associated with the lack of a comparison group. Another common bias was related to insufficient sample size, non-validated outcomes, non-standardized intervention, and use of other ongoing treatment. The vast majority of studies showed that physical therapy modalities such as biofeedback, dilators, electrical stimulation, education, multimodal physical therapy, and multidisciplinary approaches were effective for decreasing pain during intercourse and improving sexual function. The positive findings for the effectiveness of physical therapy modalities in women with PVD should be investigated further in robust and well-designed randomized controlled trials. Morin M, Carroll M-S, Bergeron S. Systematic Review of the Effectiveness of Physical Therapy Modalities in Women With Provoked Vestibulodynia. Sex Med Rev 2017;5:295-322. Copyright © 2017 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

Prospective, randomized comparison of 3 different hemoclips for the treatment of acute upper GI hemorrhage in an established experimental setting.

PubMed

Kato, Masayuki; Jung, Yunho; Gromski, Mark A; Chuttani, Ram; Matthes, Kai

2012-01-01

Recently, endoscopic clip application devices have undergone redesign and improvements to optimize their clinical use and effectiveness. Initially designed for the treatment of bleeding nonvariceal lesions, these devices are also increasingly used for the closure of perforations, fistulas, and anastomotic leaks. Several clinical studies, both randomized and nonrandomized, have used endoscopic hemoclips for hemostasis. However, no comparative studies have yet been reported in the literature comparing the latest endoscopic clip devices for usability and effectiveness for hemostasis of acute upper GI hemorrhage. We aimed to compare the usability and efficacy of 3 different types of endoscopic clip application devices in an established experimental setting by using a porcine ex-vivo simulator of upper GI hemorrhage. Randomized, controlled, ex-vivo study. Academic medical center. Spurting vessels were created within ex-vivo porcine stomachs as published in prior studies. The vessels were attached to a pressure transducer to record the pressure of the circulating blood replacement. Before the initiation of bleeding, each vessel was randomized to 1 of 3 endoscopic clipping devices: 2 different commonly used hemoclips deployed through the working channel and 1 novel clip deployed via an over-the-scope applications device. Two investigators treated 45 bleeding sites (15 bleeding sites for each device at various randomized locations in the stomach: fundus, body, and antrum). Usability was measured via the endpoints of procedure time and quantity of clips required to achieve hemostasis. Efficacy was measured via the endpoint of pressure increase (Δp) from baseline to after treatment. All of the 45 hemostasis treatments were carried out successfully. The mean procedure times were significantly different among the hemoclips, with the clip deployed in an over-the-scope fashion requiring significantly less time to attain hemostasis compared with the other 2 clips. For number of clips needed to attain hemostasis, the clip deployed in an over-the-scope fashion was significantly superior to the others. There were also significant differences among the changes in pressure (Δp ± SD) among the different hemoclips tested. Ex-vivo study. In this prospective, randomized ex-vivo study, we observed significant differences in the usability (time to achieve hemostasis and number of clips required) and the efficacy (change in pressure achieved by the hemoclips) among the 3 clips. The clip applied in the over-the-scope fashion was superior to the other 2 tested clips with regard to time to achieve hemostasis and number of clips required. Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Drug designs fulfilling the requirements of clinical trials aiming at personalizing medicine

PubMed Central

Mandrekar, Sumithra J.; Sargent, Daniel J.

2014-01-01

In the current era of stratified medicine and biomarker-driven therapies, the focus has shifted from predictions based on the traditional anatomic staging systems to guide the choice of treatment for an individual patient to an integrated approach using the genetic makeup of the tumor and the genotype of the patient. The clinical trial designs utilized in the developmental pathway for biomarkers and biomarker-directed therapies from discovery to clinical practice are rapidly evolving. While several issues need careful consideration, two critical issues that surround the validation of biomarkers are the choice of the clinical trial design (which is based on the strength of the preliminary evidence and marker prevalence), and biomarker assay related issues surrounding the marker assessment methods such as the reliability and reproducibility of the assay. In this review, we focus on trial designs aiming at personalized medicine in the context of early phase trials for initial marker validation, as well as in the context of larger definitive trials. Designs for biomarker validation are broadly classified as retrospective (i.e., using data from previously well-conducted randomized controlled trials (RCTs) versus prospective (enrichment, all-comers, hybrid or adaptive). We believe that the systematic evaluation and implementation of these design strategies are essential to accelerate the clinical validation of biomarker guided therapy. PMID:25414851

Complex Atheromatosis of the Aortic Arch in Cerebral Infarction

PubMed Central

Capmany, Ramón Pujadas; Ibañez, Montserrat Oliveras; Pesquer, Xavier Jané

2010-01-01

In many stroke patients it is not possible to establish the etiology of stroke. However, in the last two decades, the use of transesophageal echocardiography in patients with stroke of uncertain etiology reveals atherosclerotic plaques in the aortic arch, which often protrude into the lumen and have mobile components in a high percentage of cases. Several autopsy series and retrospective studies of cases and controls have shown an association between aortic arch atheroma and arterial embolism, which was later confirmed by prospectively designed studies. The association with ischemic stroke was particularly strong when atheromas were located proximal to the ostium of the left subclavian artery, when the plaque was ≥ 4 mm thick and particularly when mobile components are present. In these cases, aspirin might not prevent adequately new arterial ischemic events especially stroke. Here we review the evidence of aortic arch atheroma as an independent risk factor for stroke and arterial embolism, including clinical and pathological data on atherosclerosis of the thoracic aorta as an embolic source. In addition, the impact of complex plaques (≥ 4 mm thick, or with mobile components) on increasing the risk of stroke is also reviewed. In non-randomized retrospective studies anticoagulation was superior to antiplatelet therapy in patients with stroke and aortic arch plaques with mobile components. In a retrospective case-control study, statins significantly reduced the relative risk of new vascular events. However, given the limited data available and its retrospective nature, randomized prospective studies are needed to establish the optimal secondary prevention therapeutic regimens in these high risk patients. PMID:21804777

Complex atheromatosis of the aortic arch in cerebral infarction.

PubMed

Capmany, Ramón Pujadas; Ibañez, Montserrat Oliveras; Pesquer, Xavier Jané

2010-08-01

In many stroke patients it is not possible to establish the etiology of stroke. However, in the last two decades, the use of transesophageal echocardiography in patients with stroke of uncertain etiology reveals atherosclerotic plaques in the aortic arch, which often protrude into the lumen and have mobile components in a high percentage of cases. Several autopsy series and retrospective studies of cases and controls have shown an association between aortic arch atheroma and arterial embolism, which was later confirmed by prospectively designed studies. The association with ischemic stroke was particularly strong when atheromas were located proximal to the ostium of the left subclavian artery, when the plaque was ≥ 4 mm thick and particularly when mobile components are present. In these cases, aspirin might not prevent adequately new arterial ischemic events especially stroke. Here we review the evidence of aortic arch atheroma as an independent risk factor for stroke and arterial embolism, including clinical and pathological data on atherosclerosis of the thoracic aorta as an embolic source. In addition, the impact of complex plaques (≥ 4 mm thick, or with mobile components) on increasing the risk of stroke is also reviewed. In non-randomized retrospective studies anticoagulation was superior to antiplatelet therapy in patients with stroke and aortic arch plaques with mobile components. In a retrospective case-control study, statins significantly reduced the relative risk of new vascular events. However, given the limited data available and its retrospective nature, randomized prospective studies are needed to establish the optimal secondary prevention therapeutic regimens in these high risk patients.

Increasing Kyphosis Predicts Worsening Mobility in Older Community-Dwelling Women: A Prospective Cohort Study

PubMed Central

Katzman, Wendy B.; Vittinghoff, Eric; Ensrud, Kris; Black, Dennis M.; Kado, Deborah M.

2013-01-01

OBJECTIVES To determine whether increasing kyphosis angle was independently associated with poorer mobility as measured according to the Timed Up and Go Test (TUG), after controlling for other established risk factors. DESIGN Prospective cohort study. SETTING Eleven clinical centers in the United States. PARTICIPANTS Two thousand seven hundred seventy-seven women aged 55 to 80 randomized to the placebo arms of the Fracture Intervention Trial, a randomized controlled trial of the effect of alendronate on risk for osteoporotic fractures. MEASUREMENTS The primary predictor was change in kyphosis angle, measured using the Debrunner Kyphometer; the outcome was change in mobility, measured as performance time on the TUG. Covariates were baseline age, kyphosis angle, body mass index (BMI), self-reported health status, grip strength, change in total hip bond mineral density (BMD), and number of vertebral fractures over a mean of 4.4 years. RESULTS Greater kyphosis angle predicted longer mobility performance times (P<.001), independent of other significant predictors of worsening mobility including age, baseline kyphosis, health status, grip strength, BMI, change in hip BMD, and new vertebral fractures. TUG performance times increased by 0.02 seconds (95% confidence interval (CI) =0.01–0.03) for every 5° increase in kyphosis angle, more than the increase in mobility time of 0.01 seconds (95% CI =0.005–0.03) over 1 year observed in this cohort. CONCLUSION Increasing kyphosis angle is independently associated with worsening mobility. Interventions are needed to prevent or reduce increasing kyphosis and mobility decline. PMID:21198460

Prospective Study on the Effectiveness of Complementary Food Supplements on Improving Status of Elder Infants and Young Children in the Areas Affected by Wenchuan Earthquake

PubMed Central

Dong, Caixia; Ge, Pengfei; Ren, Xiaolan; Wang, Jie; Fan, Haoqiang; Yan, Xiang; Yin, Shi-an

2013-01-01

Objective To prospectively evaluate the efficiency of daily providing complementary food supplements decreasing malnutrition and anemia prevalence in elder infants and young children living in areas affected by Wenchuan Earthquake. Design Using promotional probability sampling method, 250 to 300 children from six-randomized townships (30 to 50 children in each township) in Kang County affected by the Earthquake were randomly chosen for follow up to evaluate intervention effectiveness using anthropometric measurement and hemoglobin level at six, twelve and eighteen months after start of intervention. Setting and Subjects All children from 6 to 18 months of age in Kang County (in North Western China) were daily provided with complementary food supplements containing multiple vitamins and minerals for up to 24 months of age. The intervention period lasted for one and half year. Results At beginning of intervention, malnutrition prevalence, including underweight, stunting and wasting were respectively 4.5%, 8.9% and 3.5%; anemia prevalence was 74.3%. After one and half year intervention, the growth and anemia status were significantly improved; the percentages of wasting, stunting underweight prevalence were decreased from 3.5%, 8.9% and 4.5% to 1.7%, 5.0% and 3.3% respectively, and the anemia rates were significantly decreased. Conclusions Our results indicated that an intervention using complementary food supplements could improve nutritional status and elevate hemoglobin level in elder infants and young children, which would significantly decrease the prevalence of malnutrition and anemia. PMID:24039797

Etomidate-Remifentanil is more Suitable for Monitored Anesthesia Care during Gastroscopy in Older Patients than Propofol-Remifentanil

PubMed Central

Shen, Xiao-Chun; Ao, Xing; Cao, Yan; Lan, Li; Liu, Xin-Man; Sun, Wen-Jing; Li, Ping; Lan, Chun-Hui

2015-01-01

Background This prospective and randomized study was designed to compare safety, potential complications, and patient and examiner satisfaction of 2 anesthetic combinations – etomidate-remifentanil and propofol-remifentanil – in elderly patients undergoing diagnostic gastroscopy. Material/Methods A group of 720 patients, aged 60–80 years, scheduled for diagnostic gastroscopy under sedation were prospectively randomized. After 0.4–0.6 μg kg−1 of remifentanil was infused, etomidate or propofol was administered. Patients in the etomidate group received doses of etomidate at 0.1–0.15 mg kg−1 followed by 4–6 mg. Patients in the propofol group received doses of propofol at 1–2 mg kg−1 followed by 20–40 mg. Physiological indexes were evaluated for the 715 of 720 patients that completed the treatment. The onset time, duration time, and discharge time were recorded. Physicians, anesthetists, and patients were surveyed to assess their satisfaction. Results Systolic pressure and diastolic pressure decreased significantly after the procedure in the propofol group (P<0.001). The average heart rate was significantly lower in the propofol group (P<0.05). No periods of desaturation (SpO2 <95%) were observed in either group. The onset time was earlier in the etomidate group (P=0.00). All adverse events, with the exception of myoclonus, were greater in the propofol group, and physician and patient satisfaction in both groups was similar. Conclusions Etomidate-remifentanil administration for sedation and analgesia during gastroscopy resulted in more stable hemodynamic responses and less adverse events in older patients. PMID:25553506

Novel robotic catheter manipulation system integrated with remote magnetic navigation for fully remote ablation of atrial tachyarrhythmias: a two-centre evaluation.

PubMed

Nölker, Georg; Gutleben, Klaus-Jürgen; Muntean, Bogdan; Vogt, Jürgen; Horstkotte, Dieter; Dabiri Abkenari, Lara; Akca, Ferdi; Szili-Torok, Tamas

2012-12-01

Studies have shown that remote magnetic navigation is safe and effective for ablation of atrial arrhythmias, although optimal outcomes often require frequent manual manipulation of a circular mapping catheter. The Vdrive robotic system ('Vdrive') was designed for remote navigation of circular mapping catheters to enable a fully remote procedure. This study details the first human clinical experience with remote circular catheter manipulation in the left atrium. This was a prospective, multi-centre, non-randomized consecutive case series that included patients presenting for catheter ablation of left atrial arrhythmias. Remote systems were used exclusively to manipulate both the circular mapping catheter and the ablation catheter. Patients were followed through hospital discharge. Ninety-four patients were included in the study, including 23 with paroxysmal atrial fibrillation (AF), 48 with persistent AF, and 15 suffering from atrial tachycardias. The population was predominately male (77%) with a mean age of 60.5 ± 11.7 years. The Vdrive was used for remote navigation between veins, creation of chamber maps, and gap identification with segmental isolation. The intended acute clinical endpoints were achieved in 100% of patients. Mean case time was 225.9 ± 70.5 min. Three patients (3.2%) crossed over to manual circular mapping catheter navigation. There were no adverse events related to the use of the remote manipulation system. The results of this study demonstrate that remote manipulation of a circular mapping catheter in the ablation of atrial arrhythmias is feasible and safe. Prospective randomized studies are needed to prove efficiency improvements over manual techniques.

Deep Tissue Massage and Nonsteroidal Anti-Inflammatory Drugs for Low Back Pain: A Prospective Randomized Trial

PubMed Central

Kocur, Piotr

2014-01-01

Objective. To investigate whether chronic low back pain therapy with deep tissue massage (DTM) gives similar results to combined therapy consisting of DTM and non-steroid anti-inflammatory drugs (NSAID). Design. Prospective controlled randomized single blinded trial. Settings. Ambulatory care of rehabilitation. Participants. 59 patients, age 51.8 ± 9.0 years, with chronic low back pain. Interventions. 2 weeks of DTM in the treatment group (TG) versus 2 weeks of DTM combined with NSAID in the control group (CG). Main Outcome Measures. Visual analogue scale, Oswestry disability index (ODI), and Roland-Morris questionnaire (RM). Results. In both the TG and the CG, a significant pain reduction and function improvement were observed. VAS decreased from 58.3 ± 18.2 to 42.2 ± 21.1 (TG) and from 51.8 ± 18.8 to 30.6 ± 21.9 (CG). RM value decreased from 9.8 ± 5.1 to 6.4 ± 4.4 (TG), and from 9.3 ± 5.5 to 6.1 ± 4.6 (CG). ODI value decreased from 29.2 ± 17.3 to 21.4 ± 15.1 (TG) and from 21.4 ± 9.4 to 16.6 ± 9.4 (CG). All pre-post-treatment differences were significant; however, there was no significant difference between the TG and the CG. Conclusion. DTM had a positive effect on reducing pain in patients with chronic low back pain. Concurrent use of DTM and NSAID contributed to low back pain reduction in a similar degree that the DTM did. PMID:24707200

Acculturation, Cultural Values, and Breastfeeding in Overweight or Obese, Low-Income, Hispanic Women at 1 Month Postpartum.

PubMed

Shin, Cha-Nam; Reifsnider, Elizabeth; McClain, Darya; Jeong, Mihyun; McCormick, David P; Moramarco, Michael

2018-05-01

Most Hispanic infants are fed formula during the first 6 weeks, and although 80% of Hispanic women initiate breastfeeding, rates of exclusive breastfeeding are much lower. Research aim: The purpose was to examine the influence of acculturation and cultural values on the breastfeeding practices of pregnant women of Mexican descent participating in the Special Supplemental Nutrition Program for Women, Infants, and Children who were enrolled in a prospective randomized clinical trial that aimed to reduce child obesity. The data were abstracted from a larger randomized clinical trial focused on prevention of child obesity. The sample consisted of 150 women of Mexican origin who were enrolled at the time of these analyses from the randomized clinical trial and had a prepregnancy body mass index of ≥ 25 and spoke English and/or Spanish. All breastfeeding data for this report came from data collection at 1 month postpartum. A higher score on the Anglo orientation scale of the Acculturation Rating Scale for Mexican Americans was associated with less breastfeeding at 1 month postpartum and less exclusive breastfeeding. Acculturation plays a role in breastfeeding practice. Exploring acculturation associated with breastfeeding can guide us to design culturally relevant interventions to promote breastfeeding exclusivity among immigrant mothers.

A randomized study comparing outcomes of stapled and hand-sutured anastomoses in patients undergoing open gastrointestinal surgery.

PubMed

Chandramohan, S M; Gajbhiye, Raj Narenda; Agwarwal, Anil; Creedon, Erin; Schwiers, Michael L; Waggoner, Jason R; Tatla, Daljit

2013-08-01

Although stapling is an alternative to hand-suturing in gastrointestinal surgery, recent trials specifically designed to evaluate differences between the two in surgery time, anastomosis time, and return to bowel activity are lacking. This trial compared the outcomes of the two in subjects undergoing open gastrointestinal surgery. Adult subjects undergoing emergency or elective surgery requiring a single gastric, small, or large bowel anastomosis were enrolled into this open-label, prospective, randomized, interventional, parallel, multicenter, controlled trial. Randomization was assigned in a 1:1 ratio between the hand-sutured group (n = 138) and the stapled group (n = 142). Anastomosis time, surgery time, and time to bowel activity were collected and compared as primary endpoints. A total of 280 subjects were enrolled from April 2009 to September 2010. Only the time of anastomosis was significantly different between the two arms: 17.6 ± 1.90 min (stapled) and 20.6 ± 1.90 min (hand-sutured). This difference was deemed not clinically or economically meaningful. Safety outcomes and other secondary endpoints were similar between the two arms. Mechanical stapling is faster than hand-suturing for the construction of gastrointestinal anastomoses. Apart from this, stapling and hand-suturing are similar with respect to the outcomes measured in this trial.

Recovery of ovarian activity in women with functional hypothalamic amenorrhea who were treated with cognitive behavior therapy.

PubMed

Berga, Sarah L; Marcus, Marsha D; Loucks, Tammy L; Hlastala, Stefanie; Ringham, Rebecca; Krohn, Marijane A

2003-10-01

To determine whether cognitive behavior therapy (CBT) targeted to problematic attitudes common among women with functional hypothalamic amenorrhea would restore ovarian function. Randomized, prospective, controlled intervention. Clinical research center in an academic medical institution. Sixteen women participated who had functional hypothalamic amenorrhea; were of normal body weight; and did not report psychiatric conditions, eating disorders, or excessive exercise. Subjects were randomized to CBT or observation for 20 weeks. Serum levels of E(2) and P and vaginal bleeding were monitored. Of eight women treated with CBT, six resumed ovulating, one had partial recovery of ovarian function without evidence of ovulation, and one did not display return of ovarian function. Of those randomized to observation, one resumed ovulating, one had partial return of ovarian function, and six did not recover. Thus, CBT resulted in a higher rate of ovarian activity (87.5%) than did observation (25.0%), chi(2) = 7.14. A cognitive behavioral intervention designed to minimize problematic attitudes linked to hypothalamic allostasis was more likely to result in resumption of ovarian activity than observation. The prompt ovarian response to CBT suggests that a tailored behavioral intervention offers an efficacious treatment option that also avoids the pitfalls of pharmacological modalities.

Laparoscopic extraperitoneal inguinal hernia repair versus open mesh repair: a prospective randomized controlled trial.

PubMed

Andersson, Bodil; Hallén, Magnus; Leveau, Per; Bergenfelz, Anders; Westerdahl, Johan

2003-05-01

This study was designed to compare an open tension-free technique (Lichtenstein repair) with a laparoscopic totally extraperitoneal hernia repair (TEP). One hundred sixty-eight men aged 30 to 65 years with primary or recurrent inguinal hernia were randomized to TEP or open mesh technique in the manner of Lichtenstein. Follow-up was after 1 and 6 weeks, and 1 year. Eighty-one patients were randomized to TEP, and 87 to open repair. For 1 patient in each group, the operation was converted to a different type of repair. No difference was seen in overall complications between the 2 groups. However, 1 patient in the TEP group underwent operation for small bowel obstruction after surgery. A higher frequency of postoperative hematomas was seen in the open group (P <.05). Patients in the TEP group consumed less analgesic after surgery (P <.001), returned to work earlier (P <.01), and had a shorter time to full recovery (P <.01). Two recurrences occurred in the TEP group 1 year after surgery. The TEP technique was associated with less postoperative pain, a shorter time to full recovery, and an earlier return to work compared with the open tension-free repair. No difference was seen in overall complications. However, 2 recurrences did occur after 1 year in the TEP group.

Breaking Bad News in obstetrics: a randomized trial of simulation followed by debriefing or lecture.

PubMed

Karkowsky, Chavi Eve; Landsberger, Ellen J; Bernstein, Peter S; Dayal, Ashlesha; Goffman, Dena; Madden, Robert C; Chazotte, Cynthia

2016-11-01

Although communication skills represent an increasingly important aspect of medical care, little has been done to assess the best method of teaching these skills. Our study was designed to assess simulation-debriefing compared to lecture in teaching skills for Breaking Bad News (BBN) in obstetrics. This is a randomized prospective trial of house staff from a large academic medical center. Subjects initially underwent baseline simulation, followed by evaluation on BBN skills by themselves, a faculty observer, and the standardized patient (SP). The subjects were then immediately randomized to a debriefing session by faculty or to a lecture about BBN. Subsequently, both groups underwent a second simulation with the same three assessments, yielding post-intervention data. 35 subjects completed both simulations. Both debriefing and lecture curricula showed improvement in scores by self (p = 0.010) and faculty (p < 0.001). The debriefing group improved significantly more than the lecture group for self-evaluation; additionally, improvements were greater for the debrief group in verbal and nonverbal skills. Long-term follow-up three months after both interventions demonstrated continued improvement in BBN. Simulation training with debriefing is effective for teaching communication skills, and superior to lecture for self-perceived improvement. Long-term follow-up suggested retention of confidence in BBN skills.

Retention of the posterior cruciate ligament versus the posterior stabilized design in total knee arthroplasty: a prospective randomized controlled clinical trial

PubMed Central

van den Boom, Lennard GH; Brouwer, Reinoud W; van den Akker-Scheek, Inge; Bulstra, Sjoerd K; van Raaij, Jos JAM

2009-01-01

Background Prosthetic design for the use in primary total knee arthroplasty has evolved into designs that preserve the posterior cruciate ligament (PCL) and those in which the ligament is routinely sacrificed (posterior stabilized). In patients with a functional PCL the decision which design is chosen depends largely on the favour and training of the surgeon. The objective of this study is to determine whether the patient's perceived outcome and speed of recovery differs between a posterior cruciate retaining total knee arthroplasty and a posterior stabilized total knee arthroplasty. Methods/Design A randomized controlled trial will be conducted. Patients who are admitted for primary unilateral TKA due to primary osteoarthrosis are included when the following inclusion criteria are met: non-fixed fixed varus or valgus deformity less than 10 degrees, age between 55 and 85 years, body mass index less than 35 kg/m2 and ASA score (American Society of Anaesthesiologists) I or II. Patients are randomized in 2 groups. Patients in the posterior cruciate retaining group will receive a prosthesis with a posterior cut-out for the posterior cruciate ligament and relatively flat topography. In patients allocated to the posterior stabilized group, in which the posterior cruciate ligament is excised, the design may substitute for this function by an intercondylar tibial prominence that articulates with the femur in flexion. Measurements will take place preoperatively and 6 weeks, 3 months, 6 months and 1 year postoperatively. At all measurement points patient's perceived outcome will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcome measures are quality of life (SF-36) and physician reported functional status and range of motion as determined with the Knee Society Clinical Rating System (KSS). Discussion In the current practice both posterior cruciate retaining and posterior stabilized designs for total knee arthroplasty are being used. To date no studies have been performed determining whether there is a difference in patient's perceived outcome between the two designs. Additionally, there is a lack of studies determining the speed of recovery in both designs as most studies only determine the final outcome. This randomised controlled study has been designed to determine whether the patient's perceived outcome and speed of recovery differs between a posterior cruciate retaining total knee arthroplasty and a posterior stabilized total knee arthroplasty. Trial Registration The trial is registered in the Netherlands Trial Registry (NTR1673). PMID:19793397

Antireflux Versus Conventional Plastic Stent in Malignant Biliary Obstruction: A Prospective Randomized Study.

PubMed

Vihervaara, Hanna; Grönroos, Juha M; Hurme, Saija; Gullichsen, Risto; Salminen, Paulina

2017-01-01

Endoscopic stents are used to relieve obstructive jaundice. The purpose of this prospective randomized study was to compare the patency of antireflux and conventional plastic biliary stent in relieving distal malignant biliary obstruction. All jaundiced patients admitted to hospital with suspected unresectable malignant distal biliary stricture between October 2009 and September 2010 were evaluated for the study. Eligible patients were randomized either to antireflux or conventional plastic stent arms. The primary endpoint was stent patency and the follow-up was continued either until the stent was occluded or until 6 months after the stent placement. At an interim analysis, antireflux stents (ARSs; n = 6) had a significantly shorter median patency of 34 (8-49) days compared with the conventional stent (n = 7) patency of 167 (38-214) days (P = .0003). Based on these results, the study was terminated due to ethical concerns. According to these results, the use of this ARS is not recommended.

A prospective randomized study comparing percutaneous nephrolithotomy under combined spinal-epidural anesthesia with percutaneous nephrolithotomy under general anesthesia.

PubMed

Singh, Vishwajeet; Sinha, Rahul Janak; Sankhwar, S N; Malik, Anita

2011-01-01

A prospective randomized study was executed to compare the surgical parameters and stone clearance in patients who underwent percutaneous nephrolithotomy (PNL) under combined spinal-epidural anesthesia (CSEA) versus those who underwent PNL under general anesthesia (GA). Between January 2008 to December 2009, 64 patients with renal calculi were randomized into 2 groups and evaluated for the purpose of this study. Group 1 consisted of patients who underwent PNL under CSEA and Group 2 consisted of patients who underwent PNL under GA. The operative time, stone clearance rate, visual pain analog score, mean analgesic dose and mean hospital stay were compared amongst other parameters. The difference between visual pain analog score after the operation and the dose of analgesic requirement was significant on statistical analysis between both groups. PNL under CSEA is as effective and safe as PNL under GA. Patients who undergo PNL under CESA require lesser analgesic dose and have a shorter hospital stay. Copyright © 2011 S. Karger AG, Basel.

Comparison of anastomotic leakage and stricture formation following layered and stapler oesophagogastric anastomosis for cancer: a prospective randomized controlled trial.

PubMed

Zhang, Y S; Gao, B R; Wang, H J; Su, Y F; Yang, Y Z; Zhang, J H; Wang, C

2010-01-01

The objective of this prospective, randomized, controlled trial, conducted from May 2002 to December 2007, was to compare post-operative anastomotic leakage and stricture formation following layered manual versus stapler oesophagogastric anastomosis in patients who underwent resection of oesophageal or gastric cardia carcinoma. Patients (n = 516) were randomized to receive either layered manual or circular stapled oesophagogastric anastomosis. Mean follow-up time was > 12 months. Anastomotic leakage occurred in one (0.4%) patient in the layered group and six (2.2%) in the stapler group; no statistically significant between-group difference. After operation, two (0.8%) patients in the layered group and 13 (5.0%) in the stapler group developed a benign oesophageal stricture; the difference between the groups was statistically significant. Compared with stapler anastomosis, layered manual anastomosis may significantly reduce the incidence of anastomotic strictures. This method is easy to apply and could be used as an alternative procedure for oesophagogastric anastomosis after resection for oesophageal or cardia carcinoma.

Evaluation of the Efficacy of Tranexamic Acid on the Surgical Field in Primary Cleft Palate Surgery on Children-A Prospective, Randomized Clinical Study.

PubMed

Durga, Padmaja; Raavula, Parvathi; Gurajala, Indira; Gunnam, Poojita; Veerabathula, Prardhana; Reddy, Mukund; Upputuri, Omkar; Ramachandran, Gopinath

2015-09-01

To assess the effect of tranexamic acid on the quality of the surgical field. Prospective, randomized, double-blind study. Institutional, tertiary referral hospital. American Society of Anesthesiologists physical status class I patients, aged 8 to 60 months with Group II or III (Balakrishnan's classification) clefts scheduled for cleft palate repair. Children were randomized into two groups. The control group received saline, and the tranexamic acid group received tranexamic acid 10 mg/kg as a bolus, 15 minutes before incision. Grade of surgical field on a 10-point scale, surgeon satisfaction, and primary hemorrhage. Significant improvements were noted in surgeon satisfaction and median grade of assessment of the surgical field (4 [interquartile range, 4 to 6] in the control group vs. 3 [interquartile range, 2 to 4] in the test group; P = .003) in the tranexamic acid group compared to the control group. Preincision administration of 10 mg/kg of tranexamic acid significantly improved the surgical field during cleft palate repair.

Prospective Teachers' Cognitive Constructs Concerning Ideal Teacher Qualifications: A Phenomenological Analysis Based on Repertory Grid Technique

ERIC Educational Resources Information Center

Kozikoglu, Ishak

2017-01-01

The aim of this study is to identify cognitive constructs of prospective teachers about ideal teacher qualifications. This study was designed as phenomenological pattern which is one of the qualitative research designs. The study was conducted with 36 prospective teachers selected from Yüzüncü Yil University, Faculty of Education. The study group…

Smoking cessation and reduction in schizophrenia (SCARIS) with e-cigarette: study protocol for a randomized control trial.

PubMed

Caponnetto, Pasquale; Polosa, Riccardo; Auditore, Roberta; Minutolo, Giuseppe; Signorelli, Maria; Maglia, Marilena; Alamo, Angela; Palermo, Filippo; Aguglia, Eugenio

2014-03-22

It is well established in studies across several countries that tobacco smoking is more prevalent among schizophrenic patients than the general population. Electronic cigarettes are becoming increasingly popular with smokers worldwide. To date there are no large randomized trials of electronic cigarettes in schizophrenic smokers. A well-designed trial is needed to compare efficacy and safety of these products in this special population. We have designed a randomized controlled trial investigating the efficacy and safety of electronic cigarette. The trial will take the form of a prospective 12-month randomized clinical study to evaluate smoking reduction, smoking abstinence and adverse events in schizophrenic smokers not intending to quit. We will also monitor quality of life, neurocognitive functioning and measure participants' perception and satisfaction of the product. A ≥50% reduction in the number of cigarettes/day from baseline, will be calculated at each study visit ("reducers"). Abstinence from smoking will be calculated at each study visit ("quitters"). Smokers who leave the study protocol before its completion and will carry out the Early Termination Visit or who will not satisfy the criteria of "reducers" and "quitters" will be defined "non responders". The differences of continuous variables between the three groups will be evaluated with the Kruskal-Wallis Test, followed by the Dunn multiple comparison test. The differences between the three groups for normally distributed data will be evaluated with ANOVA test one way, followed by the Newman-Keuls multiple comparison test. The normality of the distribution will be evaluated with the Kolmogorov-Smirnov test. Any correlations between the variables under evaluation will be assessed by Spearman r correlation. To compare qualitative data will be used the Chi-square test. The main strengths of the SCARIS study are the following: it's the first large RCT on schizophrenic patient, involving in and outpatient, evaluating the effect of a three-arm study design, and a long term of follow-up (52-weeks).The goal is to propose an effective intervention to reduce the risk of tobacco smoking, as a complementary tool to treat tobacco addiction in schizophrenia. ClinicalTrials.gov, NCT01979796.

Design of the study: how can health care help female breast cancer patients reduce their stress symptoms? A randomized intervention study with stepped-care.

PubMed

Nordin, Karin; Rissanen, Ritva; Ahlgren, Johan; Burell, Gunilla; Fjällskog, Marie-Louise; Börjesson, Susanne; Arving, Cecilia

2012-05-04

A life threatening illness such as breast cancer can lead to a secondary diagnosis of PTSD (post traumatic stress disorder) with intrusive thoughts and avoidance as major symptoms. In a former study by the research group, 80% of the patients with breast cancer reported a high level of stress symptoms close to the diagnosis, such as intrusive thoughts and avoidance behavior. These symptoms remained high throughout the study. The present paper presents the design of a randomized study evaluating the effectiveness and cost-effectiveness of a stress management intervention using a stepped-care design. Female patients over the age of 18, with a recent diagnosis of breast cancer and scheduled for adjuvant treatment in the form of chemotherapy, radiation therapy and/or hormonal therapy are eligible and will consecutively be included in the study. The study is a prospective longitudinal intervention study with a stepped-care approach, where patients will be randomised to one of two interventions in the final stage of treatment. The first step is a low intensity stress-management intervention that is given to all patients. Patients who do not respond to this level are thereafter given more intensive treatment at later steps in the program and will be randomized to more intensive stress-management intervention in a group setting or individually. The primary out-come is subjective distress (intrusion and avoidance) assessed by the Impact of Event Scale (IES). According to the power-analyses, 300 patients are planned to be included in the study and will be followed for one year. Other outcomes are anxiety, depression, quality of life, fatigue, stress in daily living and utilization of hospital services. This will be assessed with well-known psychometric tested questionnaires. Also, the cost-effectiveness of the intervention given in group or individually will be evaluated. This randomized clinical trial will provide additional empirical evidence regarding the effectiveness of a stress-management program given in group or individually during adjuvant therapy in terms of decreased stress, minimizing fatigue, and maintaining or enhancing patients' quality of life and psychological well-being. ClinicalTrials.gov Identifier: NCT01555645.

Examining Development of Curriculum Knowledge of Prospective Mathematics Teachers

ERIC Educational Resources Information Center

Sahin, Ömer; Soylu, Yasin

2017-01-01

Explanatory-confirmatory research design, one of the mixed methods research designs, was used in this study to investigate Curriculum Knowledge developments of prospective teachers regarding algebra. Cross-sectional study method, as a type of descriptive research and one of the non-experimental research designs, was used to collect quantitative…

Smoking Cessation and Reduction in Schizophrenia (SCARIS) with e-cigarette: study protocol for a randomized control trial

PubMed Central

2014-01-01

Background It is well established in studies across several countries that tobacco smoking is more prevalent among schizophrenic patients than the general population. Electronic cigarettes are becoming increasingly popular with smokers worldwide. To date there are no large randomized trials of electronic cigarettes in schizophrenic smokers. A well-designed trial is needed to compare efficacy and safety of these products in this special population. Methods/Design Intervention: We have designed a randomized controlled trial investigating the efficacy and safety of electronic cigarette. The trial will take the form of a prospective 12-month randomized clinical study to evaluate smoking reduction, smoking abstinence and adverse events in schizophrenic smokers not intending to quit. We will also monitor quality of life, neurocognitive functioning and measure participants’ perception and satisfaction of the product. Outcome measures: A ≥50% reduction in the number of cigarettes/day from baseline, will be calculated at each study visit (“reducers”). Abstinence from smoking will be calculated at each study visit (“quitters”). Smokers who leave the study protocol before its completion and will carry out the Early Termination Visit or who will not satisfy the criteria of “reducers” and “quitters” will be defined “non responders”. Statistical analysis: The differences of continuous variables between the three groups will be evaluated with the Kruskal-Wallis Test, followed by the Dunn multiple comparison test. The differences between the three groups for normally distributed data will be evaluated with ANOVA test one way, followed by the Newman-Keuls multiple comparison test. The normality of the distribution will be evaluated with the Kolmogorov-Smirnov test. Any correlations between the variables under evaluation will be assessed by Spearman r correlation. To compare qualitative data will be used the Chi-square test. Discussion The main strengths of the SCARIS study are the following: it’s the first large RCT on schizophrenic patient, involving in and outpatient, evaluating the effect of a three-arm study design, and a long term of follow-up (52-weeks). The goal is to propose an effective intervention to reduce the risk of tobacco smoking, as a complementary tool to treat tobacco addiction in schizophrenia. Trial registration ClinicalTrials.gov, NCT01979796. PMID:24655473

Randomized Trial of Treatment for Children with Sexual Behavior Problems: Ten-Year Follow-Up

ERIC Educational Resources Information Center

Carpentier, Melissa Y.; Silovsky, Jane F.; Chaffin, Mark

2006-01-01

This study prospectively follows 135 children 5-12 years of age with sexual behavior problems from a randomized trial comparing a 12-session group cognitive-behavioral therapy (CBT) with group play therapy and follows 156 general clinic children with nonsexual behavior problems. Ten-year follow-up data on future juvenile and adult arrests and…

A 12-Month Prospective, Observational Study of Treatment Regimen and Quality of Life Associated with ADHD in Central and Eastern Europe and Eastern Asia

ERIC Educational Resources Information Center

Goetz, Michal; Yeh, Chin-Bin; Ondrejka, Igor; Akay, Aynur; Herczeg, Ilona; Dobrescu, Iuliana; Kim, Boong Nyun; Jin, Xingming; Riley, Anne W.; Martenyi, Ferenc; Harrison, Gavan; Treuer, Tamas

2012-01-01

Objectives: This prospective, observational, non-randomized study aimed to describe the relationship between treatment regimen prescribed and the quality of life (QoL) of ADHD patients in countries of Central and Eastern Europe (CEE) and Eastern Asia over 12 months. Methods: 977 Male and female patients aged 6-17 years seeking treatment for…

Randomized controlled trial evaluating the temporal effects of high-intensity exercise on learning, short-term and long-term memory, and prospective memory.

PubMed

Frith, Emily; Sng, Eveleen; Loprinzi, Paul D

2017-11-01

The broader purpose of this study was to examine the temporal effects of high-intensity exercise on learning, short-term and long-term retrospective memory and prospective memory. Among a sample of 88 young adult participants, 22 were randomized into one of four different groups: exercise before learning, control group, exercise during learning, and exercise after learning. The retrospective assessments (learning, short-term and long-term memory) were assessed using the Rey Auditory Verbal Learning Test. Long-term memory including a 20-min and 24-hr follow-up assessment. Prospective memory was assessed using a time-based procedure by having participants contact (via phone) the researchers at a follow-up time period. The exercise stimulus included a 15-min bout of progressive maximal exertion treadmill exercise. High-intensity exercise prior to memory encoding (vs. exercise during memory encoding or consolidation) was effective in enhancing long-term memory (for both 20-min and 24-h follow-up assessments). We did not observe a differential temporal effect of high-intensity exercise on short-term memory (immediate post-memory encoding), learning or prospective memory. The timing of high-intensity exercise may play an important role in facilitating long-term memory. © 2017 Federation of European Neuroscience Societies and John Wiley & Sons Ltd.

Learning by (video) example: a randomized study of communication skills training for end-of-life and error disclosure family care conferences.

PubMed

Schmitz, Connie C; Braman, Jonathan P; Turner, Norman; Heller, Stephanie; Radosevich, David M; Yan, Yelena; Miller, Jane; Chipman, Jeffrey G

2016-11-01

Teaching residents to lead end of life (EOL) and error disclosure (ED) conferences is important. We developed and tested an intervention using videotapes of EOL and error disclosure encounters from previous Objective Structured Clinical Exams. Residents (n = 72) from general and orthopedic surgery programs at 2 sites were enrolled. Using a prospective, pre-post, block group design with stratified randomization, we hypothesized the treatment group would outperform the control on EOL and ED cases. We also hypothesized that online course usage would correlate positively with post-test scores. All residents improved (pre-post). At the group level, treatment effects were insignificant, and post-test performance was unrelated to course usage. At the subgroup level for EOL, low performers assigned to treatment scored higher than controls at post-test; and within the treatment group, post graduate year 3 residents outperformed post graduate year ​1 residents. To be effective, online curricula illustrating communication behaviors need face-to-face interaction, individual role play with feedback and discussion. Copyright © 2016 Elsevier Inc. All rights reserved.

Probabilistic pathway construction.

PubMed

Yousofshahi, Mona; Lee, Kyongbum; Hassoun, Soha

2011-07-01

Expression of novel synthesis pathways in host organisms amenable to genetic manipulations has emerged as an attractive metabolic engineering strategy to overproduce natural products, biofuels, biopolymers and other commercially useful metabolites. We present a pathway construction algorithm for identifying viable synthesis pathways compatible with balanced cell growth. Rather than exhaustive exploration, we investigate probabilistic selection of reactions to construct the pathways. Three different selection schemes are investigated for the selection of reactions: high metabolite connectivity, low connectivity and uniformly random. For all case studies, which involved a diverse set of target metabolites, the uniformly random selection scheme resulted in the highest average maximum yield. When compared to an exhaustive search enumerating all possible reaction routes, our probabilistic algorithm returned nearly identical distributions of yields, while requiring far less computing time (minutes vs. years). The pathways identified by our algorithm have previously been confirmed in the literature as viable, high-yield synthesis routes. Prospectively, our algorithm could facilitate the design of novel, non-native synthesis routes by efficiently exploring the diversity of biochemical transformations in nature. Copyright © 2011 Elsevier Inc. All rights reserved.

Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial.

PubMed

Foglia, Elizabeth E; Owen, Louise S; Thio, Marta; Ratcliffe, Sarah J; Lista, Gianluca; Te Pas, Arjan; Hummler, Helmut; Nadkarni, Vinay; Ades, Anne; Posencheg, Michael; Keszler, Martin; Davis, Peter; Kirpalani, Haresh

2015-03-15

Extremely preterm infants require assistance recruiting the lung to establish a functional residual capacity after birth. Sustained inflation (SI) combined with positive end expiratory pressure (PEEP) may be a superior method of aerating the lung compared with intermittent positive pressure ventilation (IPPV) with PEEP in extremely preterm infants. The Sustained Aeration of Infant Lungs (SAIL) trial was designed to study this question. This multisite prospective randomized controlled unblinded trial will recruit 600 infants of 23 to 26 weeks gestational age who require respiratory support at birth. Infants in both arms will be treated with PEEP 5 to 7 cm H2O throughout the resuscitation. The study intervention consists of performing an initial SI (20 cm H20 for 15 seconds) followed by a second SI (25 cm H2O for 15 seconds), and then PEEP with or without IPPV, as needed. The control group will be treated with initial IPPV with PEEP. The primary outcome is the combined endpoint of bronchopulmonary dysplasia or death at 36 weeks post-menstrual age. www.clinicaltrials.gov , Trial identifier NCT02139800 , Registered 13 May 2014.

Moisturizers are effective in the treatment of xerosis irrespectively from their particular formulation: results from a prospective, randomized, double-blind controlled trial.

PubMed

Shim, J H; Park, J H; Lee, J H; Lee, D Y; Lee, J H; Yang, J M

2016-02-01

Many companies claim that their moisturizers are superior to others based on their ingredients. To compare the efficacy and safety of the most popular moisturizers in the field. A randomized, double-blind, controlled study was performed on 80 patients with moderate to severe xerosis. The test agents included the newly developed cream containing topical recombinant human epidermal growth factor (EGF), its vehicle without EGF and four additional therapeutic moisturizers. The study subjects applied the test agents on designated skin areas twice daily for 4 weeks. All of the clinical assessments and non-invasive objective measurements were performed at baseline, and on days 14 and 28 of the study. All of the test agents significantly improved the clinical symptoms of xerosis. The biophysical parameters similarly improved from baseline (P < 0.05). None of the test agents performed significantly better than did another. In the treatment of xerosis, consistent and regular moisturizer use is much more important than the moisturizer's particular formulation. © 2015 European Academy of Dermatology and Venereology.

Comparison of intraosseous and infiltration injections for venous lidocaine blood concentrations and heart rate changes after injection of 2% lidocaine with 1:100,000 epinephrine.

PubMed

Wood, Mark; Reader, Al; Nusstein, John; Beck, Mike; Padgett, David; Weaver, Joel

2005-06-01

The purpose of this prospective, randomized study was to compare the venous blood levels of lidocaine and heart rate changes after intraosseous and infiltration injections of 1.8 ml of 2% lidocaine with 1:100,000 epinephrine. Using a crossover design, 20 subjects randomly received an intraosseous and infiltration injection at two separate appointments. The heart rate was measured using a pulse oximeter. Venous blood samples were collected before the injections and at 2, 5, 10, 15, 20, 25, 30, 45, and 60 min after the injections. The blinded plasma samples were analyzed for lidocaine concentrations using high-performance liquid chromatography (HPLC). The intraosseous injection resulted in a statistically significant increase in heart rate, when compared to the infiltration injection, during solution deposition and for 2 min after the injection. The plasma levels of lidocaine were not statistically different for maxillary anterior intraosseous and infiltration injections when using 1.8 ml of 2% lidocaine with 1:100,000 epinephrine.

Screening for Acromegaly in Patients with Carpal Tunnel Syndrome: A Prospective Study (ACROCARP).

PubMed

Zoicas, F; Kleindienst, A; Mayr, B; Buchfelder, M; Megele, R; Schöfl, C

2016-07-01

Early diagnosis of acromegaly prevents irreversible comorbidities and facilitates surgical cure. Carpal tunnel syndrome (CTS) is common in acromegaly and patients have often undergone surgery for CTS prior to the diagnosis of acromegaly. We hypothesized that screening CTS-patients for acromegaly could facilitate active case-finding. We prospectively enrolled 196 patients [135 women, 56.9 (range 23-103) years] who presented with CTS for surgery. Patients were asked about 6 symptoms suggestive of acromegaly using a questionnaire calculating a symptom score (0-6 points), and insulin-like-growth factor 1 (IGF-1) was measured. If IGF-1 was increased, IGF-1 measurement was repeated, and random growth hormone (GH) and/or an oral glucose tolerance test (OGTT) with assessment of GH-suppression were performed. The mean symptom score was 1.7±1.3 points. Three patients reported the maximal symptom score of 6 points, but none of them had an increased IGF-1. There was no correlation between the symptom score and IGF-1-SDS (standard deviation score) (r=0.026; p=0.71). Four patients had an IGF-1>2 SDS. In 2 patients acromegaly was ruled out using random GH and OGTT. One patient had normal IGF-1 and random GH at follow-up. One patient refused further diagnostics. In this prospective cohort of patients with CTS, the observed frequency of acromegaly was at most 0.51% (95% CI 0.03 to 2.83%). In this prospective study, none of the 196 patients with CTS had proven acromegaly. Thus, we see no evidence to justify general screening of patients with CTS for acromegaly. © Georg Thieme Verlag KG Stuttgart · New York.

The Effect of Listening to Music During Percutaneous Nephrostomy Tube Placement on Pain, Anxiety, and Success Rate of Procedure: A Randomized Prospective Study.

PubMed

Hamidi, Nurullah; Ozturk, Erdem

2017-05-01

To evaluate the effect of listening to music on pain, anxiety, and success of procedure during office-based percutaneous nephrostomy tube placement (PNTP). One hundred consecutive patients (age >18 years) with hydronephrosis were prospectively enrolled in this study. All patients were prospectively randomized to undergo office-based PNTP with (Group I, n = 50) or without music (Group II, n = 50). Anxiety levels were evaluated with State Trait Anxiety Inventory. A visual analog scale was used to evaluate pain levels, patient's satisfaction, and willingness to undergo the procedure. We also compared success rates of procedures. The mean age, duration of procedure, and gender distribution were statistically similar between the two groups. The mean postprocedural heart rates and systolic blood pressures in Group I patients were significantly lower than Group II patients (p = 0.01 and p = 0.028, respectively), whereas preprocedural pulse rate and systolic blood pressure were similar. The mean anxiety level and mean pain score of Group I were significantly lower than those of Group II (p = 0.008 and p < 0.001, respectively). Group I also carried a significant greater mean satisfaction score and willingness to undergo repeat procedure compared with Group II (p < 0.001 for both). Success rate of nephrostomy tube placement in Group I was significantly higher compared with Group II (92% vs 66%, p = 0.04). The present randomized prospective study demonstrates that listening to music during office-based PNTP decreases anxiety or pain and increases success rate of procedure. As an alternative to sedation or general anesthesia, music is easily accessible without side effect and cost.

Blood pressure and LDL-cholesterol targets for prevention of recurrent strokes and cognitive decline in the hypertensive patient: design of the European Society of Hypertension-Chinese Hypertension League Stroke in Hypertension Optimal Treatment randomized trial.

PubMed

Zanchetti, Alberto; Liu, Lisheng; Mancia, Giuseppe; Parati, Gianfranco; Grassi, Guido; Stramba-Badiale, Marco; Silani, Vincenzo; Bilo, Grzegorz; Corrao, Giovanni; Zambon, Antonella; Scotti, Lorenza; Zhang, Xinhua; Wang, HayYan; Zhang, Yuqing; Zhang, Xuezhong; Guan, Ting Rui; Berge, Eivind; Redon, Josep; Narkiewicz, Krzysztof; Dominiczak, Anna; Nilsson, Peter; Viigimaa, Margus; Laurent, Stéphane; Agabiti-Rosei, Enrico; Wu, Zhaosu; Zhu, Dingliang; Rodicio, José Luis; Ruilope, Luis Miguel; Martell-Claros, Nieves; Pinto, Fernando; Schmieder, Roland E; Burnier, Michel; Banach, Maciej; Cifkova, Renata; Farsang, Csaba; Konradi, Alexandra; Lazareva, Irina; Sirenko, Yuriy; Dorobantu, Maria; Postadzhiyan, Arman; Accetto, Rok; Jelakovic, Bojan; Lovic, Dragan; Manolis, Athanasios J; Stylianou, Philippos; Erdine, Serap; Dicker, Dror; Wei, Gangzhi; Xu, Chengbin; Xie, Hengge; Coca, Antonio; O'Brien, John; Ford, Gary

2014-09-01

The SBP values to be achieved by antihypertensive therapy in order to maximize reduction of cardiovascular outcomes are unknown; neither is it clear whether in patients with a previous cardiovascular event, the optimal values are lower than in the low-to-moderate risk hypertensive patients, or a more cautious blood pressure (BP) reduction should be obtained. Because of the uncertainty whether 'the lower the better' or the 'J-curve' hypothesis is correct, the European Society of Hypertension and the Chinese Hypertension League have promoted a randomized trial comparing antihypertensive treatment strategies aiming at three different SBP targets in hypertensive patients with a recent stroke or transient ischaemic attack. As the optimal level of low-density lipoprotein cholesterol (LDL-C) level is also unknown in these patients, LDL-C-lowering has been included in the design. The European Society of Hypertension-Chinese Hypertension League Stroke in Hypertension Optimal Treatment trial is a prospective multinational, randomized trial with a 3 × 2 factorial design comparing: three different SBP targets (1, <145-135; 2, <135-125; 3, <125  mmHg); two different LDL-C targets (target A, 2.8-1.8; target B, <1.8  mmol/l). The trial is to be conducted on 7500 patients aged at least 65 years (2500 in Europe, 5000 in China) with hypertension and a stroke or transient ischaemic attack 1-6 months before randomization. Antihypertensive and statin treatments will be initiated or modified using suitable registered agents chosen by the investigators, in order to maintain patients within the randomized SBP and LDL-C windows. All patients will be followed up every 3 months for BP and every 6 months for LDL-C. Ambulatory BP will be measured yearly. Primary outcome is time to stroke (fatal and non-fatal). Important secondary outcomes are: time to first major cardiovascular event; cognitive decline (Montreal Cognitive Assessment) and dementia. All major outcomes will be adjudicated by committees blind to randomized allocation. A Data and Safety Monitoring Board has open access to data and can recommend trial interruption for safety. It has been calculated that 925 patients would reach the primary outcome after a mean 4-year follow-up, and this should provide at least 80% power to detect a 25% stroke difference between SBP targets and a 20% difference between LDL-C targets.

Clinical outcomes in patients with node-negative breast cancer treated based on the recurrence score results: evidence from a large prospectively designed registry.

PubMed

Stemmer, Salomon M; Steiner, Mariana; Rizel, Shulamith; Soussan-Gutman, Lior; Ben-Baruch, Noa; Bareket-Samish, Avital; Geffen, David B; Nisenbaum, Bella; Isaacs, Kevin; Fried, Georgeta; Rosengarten, Ora; Uziely, Beatrice; Svedman, Christer; McCullough, Debbie; Maddala, Tara; Klang, Shmuel H; Zidan, Jamal; Ryvo, Larisa; Kaufman, Bella; Evron, Ella; Karminsky, Natalya; Goldberg, Hadassah; Shak, Steven; Liebermann, Nicky

2017-01-01

The 21-gene Recurrence Score® (RS) assay is a validated prognostic/predictive tool in ER + early-stage breast cancer. However, clinical outcome data from prospective studies in RS ≥ 11 patients are lacking, as are relevant real-life clinical practice data. In this retrospective analysis of a prospectively designed registry, we evaluated treatments/clinical outcomes in patients undergoing RS-testing through Clalit Health Services. The analysis included N0 ER + HER2-negative breast cancer patients who were RS-tested from 1/2006 through 12/2010. Medical records were reviewed to verify treatments/recurrences/survival. The cohort included 1801 patients (median follow-up, 6.2 years). Median age was 60 years, 50.4% were grade 2 and 81.1% had invasive ductal carcinoma; 48.9% had RS < 18, 40.7% RS 18-30, and 10.4% RS ≥ 31, with chemotherapy use of 1.4, 23.7, and 87.2%, respectively. The 5-year Kaplan-Meier estimates for distant recurrence were 0.8, 3.0, and 8.6%, for patients with RS < 18, RS 18-30 and RS ≥ 31, respectively; the corresponding 5-year Kaplan-Meier estimates for breast cancer death were 0.0, 0.9, and 6.2%. Chemotherapy-untreated patients with RS < 11 ( n  = 304) and 11-25 ( n  = 1037) (TAILORx categorizatio n ) had 5-year Kaplan-Meier estimates for distant recurrence risk/breast cancer death of 1.0%/0.0% and 1.3%/0.4%, respectively. Our results extend those of the prospective TAILORx trial: the 5-year Kaplan-Meier estimates for distant recurrence and breast cancer death rate for the RS < 18 patients were very low supporting the use of endocrine therapy alone. Furthermore, in chemotherapy-untreated patients with RS 11-25 (where TAILORx patients were randomized to chemoendocrine or endocrine therapy alone), 5-year distant recurrence rates were also very low, suggesting that chemotherapy would not have conferred clinically meaningful benefit.

CORTISOL CORRELATES WITH SEVERITY OF ILLNESS AND POORLY REFLECTS ADRENAL FUNCTION IN PEDIATRIC ACUTE RESPIRATORY DISTRESS SYNDROME

PubMed Central

Yehya, Nadir; Vogiatzi, Maria G.; Thomas, Neal J.; Srinivasan, Vijay

2016-01-01

Objective To test the association between random cortisol and severity of illness in a “real-world” application of current guidelines. Study design We performed a secondary analysis of a prospective observational cohort of acute respiratory distress syndrome (ARDS). Children with ARDS and vasopressor-dependent shock were identified and random cortisol levels prior to potential hydrocortisone initiation recorded. The cohort was dichotomized to cortisol < 18 μg/dL and ≥ 18 μg/dL, and hydrocortisone use and outcomes compared. Results Of 357 children with ARDS, 155 (15 non-survivors, 10%) had vasopressors initiated with cortisol drawn prior to possible hydrocortisone use. Patients with cortisol < 18 μg/dL had lower severity of illness scores, fewer organ failures, and lower vasopressor scores (all rank-sum p < 0.05). No benefit was seen with hydrocortisone in either the entire cohort, or when dichotomized by a cortisol cutoff of 18 μg/dL. In patients with cortisol ≥ 18 μg/dL, hydrocortisone was associated with increased mortality after adjustment for either organ dysfunction or vasopressor score. Conclusions In children with ARDS with vasopressor-dependent shock, low cortisol correlated with lower severity of illness. Random cortisol was a poor method of diagnosing adrenal insufficiency, and a strategy of hydrocortisone replacement for cortisol < 18 μg/dL did not target a population likely to benefit from hydrocortisone. Future guidelines should reconsider using random cortisol levels alone for assessing adrenal function. PMID:27283464

The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial.

PubMed

Huang, Jia; Lin, Zhengkun; Wang, Qin; Liu, Feiwen; Liu, Jiao; Fang, Yunhua; Chen, Shanjia; Zhou, Xiaoxuan; Hong, Wenjun; Wu, Jinsong; Madrigal-Mora, Natalia; Zheng, Guohua; Yang, Shanli; Tao, Jing; Chen, Lidian

2015-06-16

Post-stroke cognitive impairment (PSCI) lessens quality of life, restricts the rehabilitation of stroke, and increases the social and economic burden stroke imposes on patients and their families. Therefore effective treatment is of paramount importance. However, the treatment of PSCI is very limited. The primary aim of this protocol is to propose a lower cost and more effective therapy, and to confirm the long-term effectiveness of a therapeutic regimen of Traditional Chinese Medicine (TCM) rehabilitation for PSCI. A prospective, multicenter, large sample, randomized controlled trial will be conducted. A total of 416 eligible patients will be recruited from seven inpatient and outpatient stroke rehabilitation units and randomly allocated into a therapeutic regimen of TCM rehabilitation group or cognitive training (CT) control group. The intervention period of both groups will last 12 weeks (30 minutes per day, five days per week). Primary and secondary outcomes will be measured at baseline, 12 weeks (at the end of the intervention), and 36 weeks (after the 24-week follow-up period). This protocol presents an objective design of a multicenter, large sample, randomized controlled trial that aims to put forward a lower cost and more effective therapy, and confirm the long-term effectiveness of a therapeutic regimen of TCM rehabilitation for PSCI through subjective and objective assessments, as well as highlight its economic advantages. This trial was registered with the Chinese Clinical Trial Registry (identifier: ChiCTR-TRC-14004872 ) on 23 June 2014.

Preference option randomized design (PORD) for comparative effectiveness research: Statistical power for testing comparative effect, preference effect, selection effect, intent-to-treat effect, and overall effect.

PubMed

Heo, Moonseong; Meissner, Paul; Litwin, Alain H; Arnsten, Julia H; McKee, M Diane; Karasz, Alison; McKinley, Paula; Rehm, Colin D; Chambers, Earle C; Yeh, Ming-Chin; Wylie-Rosett, Judith

2017-01-01

Comparative effectiveness research trials in real-world settings may require participants to choose between preferred intervention options. A randomized clinical trial with parallel experimental and control arms is straightforward and regarded as a gold standard design, but by design it forces and anticipates the participants to comply with a randomly assigned intervention regardless of their preference. Therefore, the randomized clinical trial may impose impractical limitations when planning comparative effectiveness research trials. To accommodate participants' preference if they are expressed, and to maintain randomization, we propose an alternative design that allows participants' preference after randomization, which we call a "preference option randomized design (PORD)". In contrast to other preference designs, which ask whether or not participants consent to the assigned intervention after randomization, the crucial feature of preference option randomized design is its unique informed consent process before randomization. Specifically, the preference option randomized design consent process informs participants that they can opt out and switch to the other intervention only if after randomization they actively express the desire to do so. Participants who do not independently express explicit alternate preference or assent to the randomly assigned intervention are considered to not have an alternate preference. In sum, preference option randomized design intends to maximize retention, minimize possibility of forced assignment for any participants, and to maintain randomization by allowing participants with no or equal preference to represent random assignments. This design scheme enables to define five effects that are interconnected with each other through common design parameters-comparative, preference, selection, intent-to-treat, and overall/as-treated-to collectively guide decision making between interventions. Statistical power functions for testing all these effects are derived, and simulations verified the validity of the power functions under normal and binomial distributions.

Prospective, Randomized Comparison of One-level Mobi-C Cervical Total Disc Replacement vs. Anterior Cervical Discectomy and Fusion: Results at 5-year Follow-up

PubMed Central

Zigler, Jack E.; Jackson, Robert; Nunley, Pierce D.; Bae, Hyun W.; Kim, Kee D.; Ohnmeiss, Donna D.

2016-01-01

Introduction There is increasing interest in the role of cervical total disc replacement (TDR) as an alternative to anterior cervical discectomy and fusion (ACDF). Multiple prospective randomized studies with minimum 2 year follow-up have shown TDR to be at least as safe and effective as ACDF in treating symptomatic degenerative disc disease at a single level. The purpose of this study was to compare outcomes of cervical TDR using the Mobi-C® with ACDF at 5-year follow-up. Methods This prospective, randomized, controlled trial was conducted as a Food and Drug Administration regulated Investigational Device Exemption trial across 23 centers with 245 patients randomized (2:1) to receive TDR with Mobi-C® Cervical Disc Prosthesis or ACDF with anterior plate and allograft. Outcome assessments included a composite overall success score, Neck Disability Index (NDI), visual analog scales (VAS) assessing neck and arm pain, Short Form-12 (SF-12) health survey, patient satisfaction, major complications, subsequent surgery, segmental range of motion, and adjacent segment degeneration. Results The 60-month follow-up rate was 85.5% for the TDR group and 78.9% for the ACDF group. The composite overall success was 61.9% with TDR vs. 52.2% with ACDF, demonstrating statistical non-inferiority. Improvements in NDI, VAS neck and arm pain, and SF-12 scores were similar between groups and were maintained from earlier follow-up through 60 months. There was no significant difference between TDR and ACDF in adverse events or major complications. Range of motion was maintained with TDR through 60 months. Device-related subsequent surgeries (TDR: 3.0%, ACDF: 11.1%, p<0.02) and adjacent segment degeneration at the superior level (TDR: 37.1%, ACDF: 54.7%, p<0.03) were significantly lower for TDR patients. Conclusions Five-year results demonstrate the safety and efficacy of TDR with the Mobi-C as a viable alternative to ACDF with the potential advantage of lower rates of reoperation and adjacent segment degeneration, in the treatment of one-level symptomatic cervical degenerative disc disease. Clinical Relevance This prospective, randomized study with 5-year follow-up adds to the existing literature indicating that cervical TDR is a viable alternative to ACDF in appropriately selected patients. Level of Evidence This is a Level I study. PMID:27162712

A multicenter, randomized trial on neuroprotection with remote ischemic per-conditioning during acute ischemic stroke: the REmote iSchemic Conditioning in acUtE BRAin INfarction study protocol.

PubMed

Pico, Fernando; Rosso, Charlotte; Meseguer, Elena; Chadenat, Marie-Laure; Cattenoy, Amina; Aegerter, Philippe; Deltour, Sandrine; Yeung, Jennifer; Hosseini, Hassan; Lambert, Yves; Smadja, Didier; Samson, Yves; Amarenco, Pierre

2016-10-01

Rationale Remote ischemic per-conditioning-causing transient limb ischemia to induce ischemic tolerance in other organs-reduces final infarct size in animal stroke models. Aim To evaluate whether remote ischemic per-conditioning during acute ischemic stroke (<6 h) reduces brain infarct size at 24 h. Methods and design This study is being performed in five French hospitals using a prospective randomized open blinded end-point design. Adults with magnetic resonance imaging confirmed ischemic stroke within 6 h of symptom onset and clinical deficit of 5-25 according to National Institutes of Health Stroke Scale will be randomized 1:1 to remote ischemic per-conditioning or control (stratified by center and intravenous fibrinolysis use). Remote ischemic per-conditioning will consist of four cycles of electronic tourniquet inflation (5 min) and deflation (5 min) to a thigh within 6 h of symptom onset. Magnetic resonance imaging is repeated 24 h after stroke onset. Sample size estimates For a difference of 15 cm 3 in brain infarct growth between groups, 200 patients will be included for 5% significance and 80% power. Study outcomes The primary outcome will be the difference in brain infarct growth from baseline to 24 h in the intervention versus control groups (by diffusion-weighted image magnetic resonance imaging). Secondary outcomes include: National Institutes of Health Stroke Scale score absolute difference between baseline and 24 h, three-month modified Rankin score and daily living activities, mortality, and tolerance and side effects of remote ischemic per-conditioning. Discussion The only remote ischemic per-conditioning trial in humans with stroke did not show remote ischemic per-conditioning to be effective. REmote iSchemic Conditioning in acUtE BRAin INfarction, which has important design differences, should provide more information on the use of this intervention in patients with acute ischemic stroke.

The role of descriptive norm within the theory of planned behavior in predicting Korean Americans' exercise behavior.

PubMed

Lee, Hyo

2011-08-01

There are few studies investigating psychosocial mechanisms in Korean Americans' exercise behavior. The present study tested the usefulness of the theory of planned behavior in predicting Korean American's exercise behavior and whether the descriptive norm (i.e., perceptions of what others do) improved the predictive validity of the theory of planned behavior. Using a retrospective design and self-report measures, web-survey responses from 198 Korean-American adults were analyzed using hierarchical regression analyses. The theory of planned behavior constructs accounted for 31% of exercise behavior and 43% of exercise intention. Intention and perceived behavioral control were significant predictors of exercise behavior. Although the descriptive norm did not augment the theory of planned behavior, all original constructs--attitude, injunctive norm (a narrow definition of subjective norm), and perceived behavioral control--statistically significantly predicted leisure-time physical activity intention. Future studies should consider random sampling, prospective design, and objective measures of physical activity.

Effectiveness guidance document (EGD) for acupuncture research - a consensus document for conducting trials

PubMed Central

2012-01-01

Background There is a need for more Comparative Effectiveness Research (CER) to strengthen the evidence base for clinical and policy decision-making. Effectiveness Guidance Documents (EGD) are targeted to clinical researchers. The aim of this EGD is to provide specific recommendations for the design of prospective acupuncture studies to support optimal use of resources for generating evidence that will inform stakeholder decision-making. Methods Document development based on multiple systematic consensus procedures (written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders including patients, clinicians and payers were involved. Results Recommendations focused mainly on randomized studies and were developed for the following areas: overall research strategy, treatment protocol, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication. Conclusion The present EGD, based on an international consensus developed with multiple stakeholder involvement, provides the first systematic methodological guidance for future CER on acupuncture. PMID:22953730

Polyphenols from cocoa and vascular health-a critical review.

PubMed

Rimbach, Gerald; Melchin, Mona; Moehring, Jennifer; Wagner, Anika E

2009-11-20

Cocoa is a rich source of dietary polyphenols. In vitro as well as cell culture data indicate that cocoa polyphenols may exhibit antioxidant and anti-inflammatory, as well as anti-atherogenic activity. Several molecular targets (e.g., nuclear factor kappa B, endothelial nitric oxide synthase, angiotensin converting enzyme) have been recently identified which may partly explain potential beneficial cardiovascular effects of cocoa polyphenols. However cocoa polyphenol concentrations, as used in many cell culture studies, are not physiologically achievable. Bioavailability studies indicate that plasma concentrations of cocoa polyphenols following dietary intake are low and in the nanomolar range. Human studies regarding the effect of cocoa polyphenols on vascular health are often underpowered and lack a rigorous study design. If dietary cocoa polyphenol intake is due to chocolate its high energy content needs to be taken into account. In order to determine potential health benefits of cocoa polyphenols large scale, long term, randomized, placebo controlled studies, (ideally with a cross-over design) as well as prospective studies are warranted.

Polyphenols from Cocoa and Vascular Health—A Critical Review

PubMed Central

Rimbach, Gerald; Melchin, Mona; Moehring, Jennifer; Wagner, Anika E.

2009-01-01

Cocoa is a rich source of dietary polyphenols. In vitro as well as cell culture data indicate that cocoa polyphenols may exhibit antioxidant and anti-inflammatory, as well as anti-atherogenic activity. Several molecular targets (e.g., nuclear factor kappa B, endothelial nitric oxide synthase, angiotensin converting enzyme) have been recently identified which may partly explain potential beneficial cardiovascular effects of cocoa polyphenols. However cocoa polyphenol concentrations, as used in many cell culture studies, are not physiologically achievable. Bioavailability studies indicate that plasma concentrations of cocoa polyphenols following dietary intake are low and in the nanomolar range. Human studies regarding the effect of cocoa polyphenols on vascular health are often underpowered and lack a rigorous study design. If dietary cocoa polyphenol intake is due to chocolate its high energy content needs to be taken into account. In order to determine potential health benefits of cocoa polyphenols large scale, long term, randomized, placebo controlled studies, (ideally with a cross-over design) as well as prospective studies are warranted. PMID:20057946

Learning Design: Requirements, Practice and Prospects

ERIC Educational Resources Information Center

MacLean, Piers; Scott, Bernard

2007-01-01

Purpose: The purpose of this paper is to describe research into the requirements, practice and prospects for the field of learning design and provide the findings of this study to date alongside early recommendations for furthering the profession in the UK. Design/methodology/approach: The paper describes the findings of a review of the literature…

Prognostic Effect of Ultra-Staging Node Negative Colon Cancer without Adjuvant Chemotherapy: A Prospective National Cancer Institute Clinical Trial

PubMed Central

Protic, Mladjan; Stojadinovic, Alexander; Nissan, Aviram; Wainberg, Zev; Steele, Scott R.; Chen, David; Avital, Itzhak; Bilchik, Anton J.

2015-01-01

BACKGROUND We recently reported in a prospective randomized trial that ultra-staging of patients with colon cancer is associated with significantly improved disease-free survival (DFS) compared with conventional staging. That trial did not control for lymph node (LN) number or adjuvant chemotherapy use. STUDY DESIGN The current international prospective multi-center cooperative group trial (NCI Clinical Trial NCT00949312), “Ultra-staging in Early Colon Cancer” (UECC), evaluates whether the 12-LN quality measure and nodal ultra-staging impact DFS in patients not receiving adjuvant chemotherapy. Eligibility criteria include: a) biopsy-proven colon adenocarcinoma; b) absence of metastatic disease; c) > 12 LNs staged pathologically; d) pan-cytokeratin immunohistochemistry (IHC) of H&E-negative LNs; e) no adjuvant chemotherapy. RESULTS Of 442 patients screened, 203 patients were eligible. The majority of patients had intermediate grade (57.7%) and T3 tumors (64.9%). At a mean follow-up of 36.8±22.1 months (range 0–97 months), 94.3% remain disease-free. Recurrence was least likely in patients with ≥12, H&E negative, and IHC negative LNs (pN0i−): 2.6% vs.16.7% in the pN0i+ group (p<0.0001). CONCLUSIONS This is the first prospective report to demonstrate that patients with optimally staged node-negative colon cancer (≥12 LNs, pN0i−) are unlikely to benefit from adjuvant chemotherapy, as 97% remain disease free after primary tumor resection. Both surgical and pathological quality measures are imperative in the planning of clinical trials in non-metastatic colon cancer. PMID:26213360

Practical proof of CP element based design for 14nm node and beyond

NASA Astrophysics Data System (ADS)

Maruyama, Takashi; Takita, Hiroshi; Ikeno, Rimon; Osawa, Morimi; Kojima, Yoshinori; Sugatani, Shinji; Hoshino, Hiromi; Hino, Toshio; Ito, Masaru; Iizuka, Tetsuya; Komatsu, Satoshi; Ikeda, Makoto; Asada, Kunihiro

2013-03-01

To realize HVM (High Volume Manufacturing) with CP (Character Projection) based EBDW, the shot count reduction is the essential key. All device circuits should be composed with predefined character parts and we call this methodology "CP element based design". In our previous work, we presented following three concepts [2]. 1) Memory: We reported the prospects of affordability for the CP-stencil resource. 2) Logic cell: We adopted a multi-cell clustering approach in the physical synthesis. 3) Random interconnect: We proposed an ultra-regular layout scheme using fixed size wiring tiles containing repeated tracks and cutting points at the tile edges. In this paper, we will report the experimental proofs in these methodologies. In full chip layout, CP stencil resource management is critical key. From the MCC-POC (Proof of Concept) result [1], we assumed total available CP stencil resource as 9000um2. We should manage to layout all circuit macros within this restriction. Especially the issues in assignment of CP-stencil resource for the memory macros are the most important as they consume considerable degree of resource because of the various line-ups such as 1RW-, 2RW-SRAMs, Resister Files and ROM which require several varieties of large size peripheral circuits. Furthermore the memory macros typically take large area of more than 40% of die area in the forefront logic LSI products so that the shot count increase impact is serious. To realize CP-stencil resource saving we had constructed automatic CP analyzing system. We developed two types of extraction mode of simple division by block and layout repeatability recognition. By properly controlling these models based upon each peripheral circuit characteristics, we could minimize the consumption of CP stencil resources. The estimation for 14nm technology node had been performed based on the analysis of practical memory compiler. The required resource for memory macro is proved to be affordable value which is 60% of full CP stencil resource and wafer level converted shot count is proved to be the level which meets 100WPH throughput. In logic cell design, circuit performance verification result after the cell clustering has been estimated. The cell clustering by the acknowledgment of physical distance proved to owe large penalty mainly in the wiring length. To reduce this design penalty, we proposed CP cell clustering by the acknowledgment of logical distance. For shot-count reduction of random interconnect area design, we proposed a more structural routing architecture which consists of the track exchange and the via position arrangement. Putting these design approaches together, we can design CP stencils to hit the target throughput within the area constraint. From the analysis for other macros such as analog, I/O, and DUMMY, it has proved that we don't need special CP design approach than legacy pattern matching CP extraction. From all these experimental results we get good prospects to the reality of full CP element based layout.

A prospective randomized study comparing laparoscopic transabdominal preperitoneal (TAPP) versus Lichtenstein repair for bilateral inguinal hernias.

PubMed

Ielpo, Benedetto; Duran, Hipolito; Diaz, Eduardo; Fabra, Isabel; Caruso, Riccardo; Malavé, Luis; Ferri, Valentina; Lazzaro, Sara; Kalivaci, Denis; Quijano, Yolanda; Vicente, Emilio

2017-07-19

In literature, only a few studies have prospectively compared the results of laparoscopic with open inguinal hernia repair yet none have compared bilateral inguinal hernia repair. The aim of this study is to compare the open Lichtenstein repair (OLR) with laparoscopic trans-abdominal preperitoneal (TAPP) repair in patients undergoing surgery for bilateral inguinal hernia. Patients were prospectively randomized between March 2013 and March 2015. Outcome parameters included hospital stay, operation time, postoperative complications, immediate postoperative pain and chronic pain, recurrence and quality of life. Sixty-one patients underwent TAPP repair and 73 underwent OLR. TAPP procedure had less early post-operative pain up to 7 days from surgery (p = 0.003), a shorter length of hospital stay (p = 0.001), less postoperative complications (p = 0.012) and less chronic pain (0.04) when compared with the OLR approach. TAPP procedure for bilateral inguinal hernia effectively reduces early postoperative pain, hospital stay and postoperative complications. Copyright © 2017 Elsevier Inc. All rights reserved.

Progressive loss of pancreatic function in chronic pancreatitis is delayed by main pancreatic duct decompression. A longitudinal prospective analysis of the modified puestow procedure.

PubMed

Nealon, W H; Thompson, J C

1993-05-01

This study evaluated the effect of operative drainage of the main pancreatic duct (MPD) on functional derangements associated with chronic pancreatitis (CP). The author previously reported delayed functional impairment in an evaluation of the impact of operative drainage in patients with CP. The author now reports on a prospective study of 143 patients with this diagnosis. Each patient underwent 1) ERCP, 2) the Bentiromide PABA, 3) 72-hour fecal fat test, 4) oral glucose tolerance test (OGTT) and 5) fat meal (LIPOMUL)--stimulated pancreatic polypeptide release (PP). All patients were stratified as mild/moderate (M/M) or severe CP on the basis of a 5-point system that was developed by the author. Patients were studied at 16-month intervals. All 143 patients underwent initial and follow-up evaluations in a mean follow-up of 47.3 months; 83 of 143 patients had M/M grade at initial evaluation. Eighty-seven patients underwent (MPD) decompression to relieve abdominal pain. In a separate prospective 17 patients with a diagnosis of CP, a grade of M/M and non-disabling abdominal pain were randomized to operative or non-operative treatment; 9 of these randomized patients were operated upon and 8 were not. No patient improved their grade during follow-up; 47 of 83 M/M patients had operative drainage and 36 did not. This grade was preserved in 41 of 47 (87%) operated patients but in only 8 of the 36 non-operated patients (22%). In the randomized trial, seven of nine operated patients retained their functional status in follow-up, whereas only two of eight patients (25%) randomized to non-operation preserved their functional grade. These data in this large study as well as among a previous randomized sample, support a policy of early operative drainage before the development of irreversible functional impairment in patients with chronic pancreatitis and associated dilation of the main pancreatic duct.

Primary repair of penetrating colon injuries: a systematic review.

PubMed

Singer, Marc A; Nelson, Richard L

2002-12-01

Primary repair of penetrating colon injuries is an appealing management option; however, uncertainty about its safety persists. This study was conducted to compare the morbidity and mortality of primary repair with fecal diversion in the management of penetrating colon injuries by use of a meta-analysis of randomized, prospective trials. We searched for prospective, randomized trials in MEDLINE (1966 to November 2001), the Cochrane Library, and EMBase using the terms colon, penetrating, injury, colostomy, prospective, and randomized. Studies were included if they were randomized, controlled trials that compared the outcomes of primary repair with fecal diversion in the management of penetrating colon injuries. Five studies were included. Reviewers performed data extraction independently. Outcomes evaluated from each trial included mortality, total complications, infectious complications, intra-abdominal infections, wound complications, penetrating abdominal trauma index, and length of stay. Peto odds ratios for combined effect were calculated with a 95 percent confidence interval for each outcome. Heterogeneity was also assessed for each outcome. The penetrating abdominal trauma index of included subjects did not differ significantly between studies. Mortality was not significantly different between groups (odds ratio, 1.70; 95 percent confidence interval, 0.51-5.66). However, total complications (odds ratio, 0.28; 95 percent confidence interval, 0.18-0.42), total infectious complications (odds ratio, 0.41; 95 percent confidence interval, 0.27-0.63), abdominal infections including dehiscence (odds ratio, 0.59; 95 percent confidence interval, 0.38-0.94), abdominal infections excluding dehiscence (odds ratio, 0.52; 95 percent confidence interval, 0.31-0.86), wound complications including dehiscence (odds ratio, 0.55; 95 percent confidence interval, 0.34-0.89), and wound complications excluding dehiscence (odds ratio, 0.43; 95 percent confidence interval, 0.25-0.76) all significantly favored primary repair. Meta-analysis of currently published randomized, controlled trials favors primary repair over fecal diversion for penetrating colon injuries.

Prospective, randomized, blinded, comparative study of injectable micronized dehydrated amniotic/chorionic membrane allograft for plantar fasciitis--a feasibility study.

PubMed

Zelen, Charles M; Poka, Attila; Andrews, James

2013-10-01

Specialized treatment of plantar fasciitis that can reduce inflammation and promote healing may be a possible alternative prior to surgical intervention. We report the results of a randomized clinical trial examining the efficacy of micronized dehydrated human amniotic/chorionic membrane (mDHACM) injection as a treatment for chronic refractory plantar fasciitis. An institutional review board-approved, prospective, randomized, single-center clinical trial was performed. Forty-five patients were randomized to receive injection of 2 cc 0.5% Marcaine plain, then either 1.25 cc saline (controls), 0.5 cc mDHACM, or 1.25 cc mDHACM. Follow-up visits occurred over 8 weeks to measure function, pain, and functional health and well-being. Significant improvement in plantar fasciitis symptoms was observed in patients receiving 0.5 cc or 1.25 cc mDHACM versus controls within 1 week of treatment and throughout the study period. At 1 week, American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot scores increased by a mean of 2.2 ± 17.4 points for controls versus 38.7 ± 11.4 points for those receiving 0.5 cc mDHACM (P < .001) and 33.7 ± 14.0 points for those receiving 1.25 cc mDHACM (P < .001). By week 8 AOFAS Hindfoot scores increased by a mean of 12.9 ± 16.9 points for controls versus 51.6 ± 10.1 and 53.3 ± 9.4 for those receiving 0.5 cc and 1.25 cc mDHACM, respectively (both P < .001). No significant difference in treatment response was observed in patients receiving 0.5 cc versus 1.25 cc mDHACM. In patients with refractory plantar fasciitis, mDHACM is a viable treatment option. Larger studies are needed to confirm our findings. Level I, prospective randomized study.

Dose-Reduced Versus Standard Conditioning Followed by Allogeneic Stem-Cell Transplantation for Patients With Myelodysplastic Syndrome: A Prospective Randomized Phase III Study of the EBMT (RICMAC Trial).

PubMed

Kröger, Nicolaus; Iacobelli, Simona; Franke, Georg-Nikolaus; Platzbecker, Uwe; Uddin, Ruzena; Hübel, Kai; Scheid, Christof; Weber, Thomas; Robin, Marie; Stelljes, Matthias; Afanasyev, Boris; Heim, Dominik; Deliliers, Giorgio Lambertenghi; Onida, Francesco; Dreger, Peter; Pini, Massimo; Guidi, Stefano; Volin, Liisa; Günther, Andreas; Bethge, Wolfgang; Poiré, Xavier; Kobbe, Guido; van Os, Marleen; Brand, Ronald; de Witte, Theo

2017-07-01

Purpose To compare a reduced-intensity conditioning regimen (RIC) with a myeloablative conditioning regimen (MAC) before allogeneic transplantation in patients with myelodysplastic syndrome (MDS) within a randomized trial. Patients and Methods Within the European Society of Blood and Marrow Transplantation, we conducted a prospective, multicenter, open-label, randomized phase III trial that compared a busulfan-based RIC with MAC in patients with MDS or secondary acute myeloid leukemia. A total of 129 patients were enrolled from 18 centers. Patients were randomly assigned in a 1:1 ratio and were stratified according to donor, age, and blast count. Results Engraftment was comparable between both groups. The CI of acute graft-versus-host disease II to IV was 32.3% after RIC and 37.5% after MAC ( P = .35). The CI of chronic graft-versus-host disease was 61.6% after RIC and 64.7% after MAC ( P = .76). The CI of nonrelapse mortality after 1 year was 17% (95% CI, 8% to 26%) after RIC and 25% (95% CI, 15% to 36%) after MAC ( P = .29). The CI of relapse at 2 years was 17% (95% CI, 8% to 26%) after RIC and 15% (95% CI, 6% to 24%) after MAC ( P = .6), which resulted in a 2-year relapse-free survival and overall survival of 62% (95% CI, 50% to 74%) and 76% (95% CI, 66% to 87%), respectively, after RIC, and 58% (95% CI, 46% to 71%) and 63% (95% CI, 51% to 75%), respectively, after MAC ( P = .58 and P = .08, respectively). Conclusion This prospective, randomized trial of the European Society of Blood and Marrow Transplantation provides evidence that RIC resulted in at least a 2-year relapse-free survival and overall survival similar to MAC in patients with MDS or secondary acute myeloid leukemia.

A randomized controlled trial of long term effect of BCM guided fluid management in MHD patients (BOCOMO study): rationales and study design

PubMed Central

2012-01-01

Background Bioimpedance analysis (BIA) has been reported as helpful in identifying hypervolemia. Observation data showed that hypervolemic maintenance hemodialysis (MHD) patients identified using BIA methods have higher mortality risk. However, it is not known if BIA-guided fluid management can improve MHD patients’ survival. The objectives of the BOCOMO study are to evaluate the outcome of BIA guided fluid management compared with standard care. Methods This is a multicenter, prospective, randomized, controlled trial. More than 1300 participants from 16 clinical sites will be included in the study. The enrolment period will last 6 months, and minimum length of follow-up will be 36 months. MHD patients aged between 18 years and 80 years who have been on MHD for at least 3 months and meet eligibility criteria will be invited to participate in the study. Participants will be randomized to BIA arm or control arm in a 1:1 ratio. A portable whole body bioimpedance spectroscopy device (BCM—Fresenius Medical Care D GmbH) will be used for BIA measurement at baseline for both arms of the study. In the BIA arm, additional BCM measurements will be performed every 2 months. The primary intent-to-treat analysis will compare outcomes for a composite endpoint of death, acute myocardial infarction, stroke or incident peripheral arterial occlusive disease between groups. Secondary endpoints will include left ventricular wall thickness, blood pressure, medications, and incidence and length of hospitalization. Discussions Previous results regarding the benefit of strict fluid control are conflicting due to small sample sizes and unstable dry weight estimating methods. To our knowledge this is the first large-scale, multicentre, prospective, randomized controlled trial to assess whether BIS-guided volume management improves outcomes of MHD patients. The endpoints of the BOCOMO study are of utmost importance to health care providers. In order to obtain that aim, the study was designed with very careful important considerations related to the endpoints, sample size, inclusion criteria, exclusion criteria and so on. For example, annual mortality of Beijing MHD patients was around 10%. To reach statistical significance, the sample size will be very large. By using composite endpoint, the sample size becomes reasonable and feasible. Limiting inclusion to patients with urine volume less than 800 ml/day the day before dialysis session will limit confounding due to residual renal function effects on the measured parameters. Patients who had received BIS measurement within 3 months prior to enrolment are excluded as data from such measurements might lead to protocol violation. Although not all patients enrolled will be incident patients, we will record the vintage of dialysis in the multivariable analysis. Trial registration Current Controlled Trials NCT01509937 PMID:23006960

Cardiac effects of granisetron in a prospective crossover randomized dose comparison trial.

PubMed

Cakir, F B; Yapar, O; Canpolat, C; Akalin, F; Berrak, S G

2012-10-01

Cardiac side effects of granisetron have been studied mostly in adult patients that are using cardiotoxic chemotherapeutics. There is limited evidence in pediatric age group and no information in pediatric oncology patients with non-cardiotoxic chemotherapeutics. In this prospective, crossover randomized study, the cardiac side effects of granisetron are compared in pediatric oncology patients who had carboplatin based chemotherapy. They were randomized to receive either 10 or 40 μg kg(-1) dose(-1) of granisetron before each cycle of chemotherapy. We drew blood for creatine phosphokinase (CPK), CPK-muscle band (MB) and Troponin-T before and 24 h after administering granisetron. Electrocardiography (ECG) tracings were taken at 0, 1, 2, 3, 6 and 24 h of granisetron. Twenty-four hours Holter ECG monitorisation was performed after each granisetron infusion. A total of 16 patients (median 8.7 years of age) were treated with weekly consecutive courses of carboplatin. There was bradycardia (p = 0.000) in patients that had granisetron at 40 μg/kg and PR interval was shortened in patients that had granisetron at 10 μg/kg dose (p = 0.021). At both doses of granisetron, QTc interval and dispersion were found to be similar. CPK, CK-MB and Troponin-T values were found to be normal before and 24 h after granisetron infusion. As the first study that has studied cardiac side effects of granisetron in patients that are not using cardiotoxic chemotherapeutics, we conclude that granisetron at 40 μg kg(-1) dose(-1) causes bradycardia only. We have also demonstrated that granisetron does not cause any clinically cardiac side effects either at 10 or 40 μg kg(-1) dose(-1). However, our results should be supported by prospective randomized studies with larger samples of patient groups.

Comparison of Suction Versus Nonsuction Drainage After Lung Resections: A Prospective Randomized Trial.

PubMed

Gocyk, Wojciech; Kużdżał, Jarosław; Włodarczyk, Janusz; Grochowski, Zbigniew; Gil, Tomasz; Warmus, Janusz; Kocoń, Piotr; Talar, Piotr; Obarski, Piotr; Trybalski, Łukasz

2016-10-01

Sufficiently large, prospective randomized trials comparing suction drainage and nonsuction drainage are lacking. The aim of the present study was to compare the effects of suction drainage and nonsuction drainage on the postoperative course in patients who have undergone lung resection. This prospective, randomized trial included patients undergoing different types of lung resections. On the day of surgery, suction drainage at -20 cm H2O was used. On the morning of the first postoperative day, patients, in whom the pulmonary parenchyma was fully reexpanded, were randomized in the ratio of 1:1. Patients assigned to group A continued with suction drainage, while those assigned to group B underwent nonsuction drainage. The study included 254 patients, with 127 patients in each group. The drainage volumes were 1098.8 mL and 814.4 mL in groups A and B, respectively (p = 0.0014). The times to chest tube removal were 5.61 days and 4.49 days in groups A and B, respectively (p = 0.0014). Prolonged air leakage occurred in 5.55% of patients in group A and in 0.7% of patients in group B (p = 0.032), and asymptomatic residual air spaces were noted in 0.8% of patients in group A and 9.4% of patients in group B (p = 0.0018). Nonsuction drainage is more effective than suction drainage with regard to drainage volume, drainage duration, and incidence of persistent air leakage. However, it is associated with a higher incidence of asymptomatic residual air spaces. Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Does press-fit technique reduce tunnel volume enlargement after anterior cruciate ligament reconstruction with autologous hamstring tendons? A prospective randomized computed tomography study.

PubMed

Hwang, Dae-Hee; Shetty, Gautam M; Kim, Jong In; Kwon, Jae Ho; Song, Jae-Kwang; Muñoz, Michael; Lee, Jun Seop; Nha, Kyung-Wook

2013-01-01

The purpose of this prospective, randomized, computed tomography-based study was to investigate whether the press-fit technique reduces tunnel volume enlargement (TVE) and improves the clinical outcome after anterior cruciate ligament reconstruction at a minimum follow-up of 1 year compared with conventional technique. Sixty-nine patients undergoing primary ACL reconstruction using hamstring autografts were randomly allocated to either the press-fit technique group (group A) or conventional technique group (group B). All patients were evaluated for TVE and tunnel widening using computed tomography scanning, for functional outcome using International Knee Documentation Committee and Lysholm scores, for rotational stability using the pivot-shift test, and for anterior laxity using the KT-2000 arthrometer at a minimum of 1-year follow-up. There were no significant differences in TVE between the 2 groups. In group A, in which the press-fit technique was used, mean volume enlargement in the femoral tunnel was 65% compared with 71.5% in group B (P = .84). In group A, 57% (20 of 35) of patients developed femoral TVE compared with 67% (23 of 34) of patients in group B (P = .27). Both groups showed no significant difference for functional outcome (mean Lysholm score P = .73, International Knee Documentation Committee score P = .15), or knee laxity (anterior P = .78, rotational P = .22) at a minimum follow-up of 1 year. In a comparison of press-fit and conventional techniques, there were no significant differences in TVE and clinical outcome at short-term follow-up. Level II, therapeutic study, prospective randomized clinical trial. Copyright © 2013 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

A comparative, prospective, and randomized study of two conservative treatment protocols for first-episode lateral ankle ligament injuries.

PubMed

Prado, Marcelo Pires; Mendes, Alberto Abussamra Moreira; Amodio, Daniel Tasseto; Camanho, Gilberto Luis; Smyth, Niall A; Fernandes, Tulio Diniz

2014-03-01

The objective of this study was to investigate functional results, the amount of time that patients missed from regular working activities, and the incidence of residual mechanical ankle instability following conservative treatment of a first episode of severe lateral ankle ligament sprain (with articular instability). This prospective and randomized study included 186 patients with severe lateral ankle ligament injuries, who were randomly assigned into 2 conservative treatment groups. In group A, participants were treated with a walking boot with weight-bearing allowed, pain management, ice, and elevation with restricted joint mobilization for 3 weeks. In group B, patients were treated with a functional brace for 3 weeks. After this period, patients from both groups were placed in a short, functional brace for an additional 3 weeks, during which they also started a rehabilitation program. No statistically significant difference was found in pain intensity score between the 2 groups; however, functional evaluations based on the AOFAS ankle and hindfoot score system showed a statistically significant improvement in the group treated with the functional brace. In addition, the average recovery period necessary for patients of group B to resume their duties was shorter than that for patients in group A. No significant difference was detected in residual mechanical ankle instability between the 2 groups. Patients with severe lateral ankle ligament lesions treated with a functional brace were shown to exhibit somewhat better results than those treated with a walking boot, and both methods presented a very low incidence of residual chronic instability. We found adequate conservative treatment was sufficient to reestablish ankle stability and that functional treatment had a marginally better clinical short-term outcome with a shorter average recovery period. Level I, prospective randomized study.

Unilateral versus bilateral neck exploration for primary hyperparathyroidism: a prospective randomized controlled trial.

PubMed

Bergenfelz, Anders; Lindblom, Pia; Tibblin, Sten; Westerdahl, Johan

2002-11-01

To compare unilateral and bilateral neck exploration for primary hyperparathyroidism in a prospective randomized controlled trial. Based on the assumption that unilateral neck exploration for a solitary parathyroid adenoma should reduce operating time and morbidity, a variety of minimally invasive procedures have challenged the idea that bilateral neck exploration is the gold standard for the surgical treatment of primary hyperparathyroidism. However, to date, no open prospective randomized trial has been published comparing unilateral and bilateral neck exploration. Ninety-one patients with the preoperative diagnosis of primary hyperparathyroidism were randomized to unilateral or bilateral neck exploration. Preoperative scintigraphy and intraoperative parathyroid hormone measurement guided the unilateral exploration. Gross morphology and frozen section determined the extent of parathyroid tissue resection in the bilateral group. The primary end-point was the use of postoperative medication for hypocalcemic symptoms. Eighty-eight patients (97%) were cured. Histology and cure rate did not differ between the two groups. Patients in the bilateral group consumed more oral calcium, had lower serum calcium values on postoperative days 1 to 4, and had a higher incidence of early severe symptomatic hypocalcemia compared with patients in the unilateral group. In addition, for patients undergoing surgery for a solitary parathyroid adenoma, unilateral exploration was associated with a shorter operative time. The cost for the two procedures did not differ. Patients undergoing a unilateral procedure had a lower incidence of biochemical and severe symptomatic hypocalcemia in the early postoperative period compared with patients undergoing bilateral exploration. Unilateral neck exploration with intraoperative parathyroid hormone assessment is a valid surgical strategy in patients with primary hyperparathyroidism with distinct advantages, especially for patients with solitary parathyroid adenoma.

Prospective randomized study comparing coronary artery bypass grafting with the new mini-extracorporeal circulation Jostra System or with a standard cardiopulmonary bypass.

PubMed

Remadi, Jean Paul; Rakotoarivelo, Zava; Marticho, Paul; Benamar, Amar

2006-01-01

To assess the potential benefits of a new concept of cardiopulmonary bypass (CPB), the mini-extracorporeal circulation (MECC) Jostra System, we conducted a prospective randomized study among patients who underwent coronary artery bypass grafting (CABG) with a MECC Jostra System or with a standard CPB. In a prospective randomized study, 400 patients underwent elective CABG using a standard CPB (200 patients) or a Jostra MECC System (200 patients). The patients were randomly assigned to have preoperative data similar for both groups. The operative mortality rate (< 30 days) was 1.5% for the MECC group and 2.5% for the CPB group (P = NS). Low-cardiac-output syndrome occurred in 0.66% and 4% for the CPB group (P < .001.). The inflammatory response was significantly reduced with the MECC. Likewise, C-reactive protein release was significantly higher in group B at 24 hours (69.6 +/- 38.5 vs 40.8 +/- 21.8 mg/L for the group A, P < .01) and at 48 hours (116.7 +/- 47.0 vs 65.4 +/- 39.5 mg/L, P < .05) postoperatively. In the CPB group, there was a significantly higher decrease of hematocrit and hemoglobin rate. So, the intraoperative transfusion rate amounted to 6% for the MECC group and 12.8% for the CPB group (P < .001). Patients in the CPB group had significantly higher levels of postoperative blood creatinine and urea. The MECC system is a new concept of CPB that seems to be reliable and safe. To perform CABG, the MECC provides an excellent surgical exposure like a standard CPB and a better biologic profile like CABG without CPB.

Stand-alone anchored cage versus cage with plating for single-level anterior cervical discectomy and fusion: a prospective, randomized, controlled study with a 2-year follow-up.

PubMed

Nemoto, Osamu; Kitada, Akira; Naitou, Satoko; Tachibana, Atsuko; Ito, Yuya; Fujikawa, Akira

2015-07-01

To avoid complications associated with plating in anterior cervical discectomy and fusion (ACDF), stand-alone anchored PEEK cage was developed and favourable outcomes with a low rate of dysphasia have been described. The objective of this study was to compare the clinical and radiological outcomes of ACDF using a standalone anchored PEEK cage (PREVAIL; Medtronic Sofamor Danek, Memphis, TN) with those of a PEEK cage with plating in a prospective randomized manner. Fifty patients with single-level cervical radiculopathy were randomly assigned to a PREVAIL or a PEEK cage with plating. Following 3, 6, 12, and 24 months, clinical and radiological outcomes were assessed. The mean surgical time for the patients with a PREVAIL was significantly shorter than that for those with a PEEK cage with plating. The clinical outcomes evaluated by visual analogue scale for pain and the Odom's criteria were comparable between both the groups. Both the groups demonstrated the high fusion rate (92% in PREVAIL; 96% in PEEK cage with plating). The subsidence rate and the improvement of cervical alignment were comparable between both the groups. The incidence of adjacent-level ossification was significantly lower for patients with a PREVAIL than that for those with a PEEK cage with plating. The rate of dysphasia graded by the method of Bazaz and measurement of prevertebral soft tissue swelling indicated no significant differences between both the groups. Our prospective randomized study confirmed that stand-alone anchored PEEK cage is a valid alternative to plating in ACDF with a low rate of adjacent-level ossification. However, the potential to reduce the incidence of dysphasia was not confirmed.

Oncology E-Learning for Undergraduate. A Prospective Randomized Controlled Trial.

PubMed

da Costa Vieira, René Aloisio; Lopes, Ana Helena; Sarri, Almir José; Benedetti, Zuleica Caulada; de Oliveira, Cleyton Zanardo

2017-06-01

The e-learning education is a promising method, but there are few prospective randomized publications in oncology. The purpose of this study was to assess the level of retention of information in oncology from undergraduate students of physiotherapy. A prospective, controlled, randomized, crossover study, 72 undergraduate students of physiotherapy, from the second to fourth years, were randomized to perform a course of physiotherapy in oncology (PHO) using traditional classroom or e-learning. Students were offered the same content of the subject. The teacher in the traditional classroom model and the e-learning students used the Articulate® software. The course tackled the main issues related to PHO, and it was divided into six modules, 18 lessons, evaluated by 126 questions. A diagnosis evaluation was performed previous to the course and after every module. The sample consisted of 67 students, allocated in groups A (n = 35) and B (n = 32), and the distribution was homogeneous between the groups. Evaluating the correct answers, we observed a limited score in the pre-test (average grade 44.6 %), which has significant (p < 0.001) improvement in post-test evaluation (average grade 73.9 %). The correct pre-test (p = 0.556) and post-test (p = 0.729) evaluation and the retention of information (p = 0.408) were not different between the two groups. The course in PHO allowed significant acquisition of knowledge to undergraduate students, but the level of information retention was statistically similar between the traditional classroom form and the e-learning, a fact that encourages the use of e-learning in oncology. REBECU1111-1142-1963.

Physical function outcome in cervical radiculopathy patients after physiotherapy alone compared with anterior surgery followed by physiotherapy: a prospective randomized study with a 2-year follow-up.

PubMed

Peolsson, Anneli; Söderlund, Anne; Engquist, Markus; Lind, Bengt; Löfgren, Håkan; Vavruch, Ludek; Holtz, Anders; Winström-Christersson, Annelie; Isaksson, Ingrid; Öberg, Birgitta

2013-02-15

Prospective randomized study. To investigate differences in physical functional outcome in patients with radiculopathy due to cervical disc disease, after structured physiotherapy alone (consisting of neck-specific exercises with a cognitive-behavioral approach) versus after anterior cervical decompression and fusion (ACDF) followed by the same structured physiotherapy program. No earlier studies have evaluated the effectiveness of a structured physiotherapy program or postoperative physical rehabilitation after ACDF for patients with magnetic resonance imaging-verified nerve compression due to cervical disc disease. Our prospective randomized study included 63 patients with radiculopathy and magnetic resonance imaging-verified nerve root compression, who were randomized to receive either ACDF in combination with physiotherapy or physiotherapy alone. For 49 of these patients, an independent examiner measured functional outcomes, including active range of neck motion, neck muscle endurance, and hand-related functioning before treatment and at 3-, 6-, 12-, and 24-month follow-ups. There were no significant differences between the 2 treatment alternatives in any of the measurements performed (P = 0.17-0.91). Both groups showed improvements over time in neck muscle endurance (P ≤ 0.01), manual dexterity (P ≤ 0.03), and right-handgrip strength (P = 0.01). Compared with a structured physiotherapy program alone, ACDF followed by physiotherapy did not result in additional improvements in neck active range of motion, neck muscle endurance, or hand-related function in patients with radiculopathy. We suggest that a structured physiotherapy program should precede a decision for ACDF intervention in patients with radiculopathy, to reduce the need for surgery. 2.

A Prospective, Randomized, Open-Label, Blinded, Endpoint Study Exploring Platelet Response to Half-Dose Prasugrel and Ticagrelor in Patients with the Acute Coronary Syndrome: HOPE-TAILOR Study.

PubMed

Jin, Cai De; Kim, Moo Hyun; Bang, Junghee; Serebruany, Victor

The optimal dosing of novel oral P2Y12 receptor platelet inhibitors such as prasugrel or ticagrelor is unclear and especially challenging in East Asians. We hypothesize that half-dose prasugrel and ticagrelor may be sufficient for long-term maintenance management in Korean patients with the acute coronary syndrome (ACS) compared with conventional dosages. HOPE-TAILOR (Half Dose of Prasugrel and Ticagrelor in Platelet Response after Acute Coronary Syndromes) is a prospective, randomized, open-label, blinded, endpoint (PROBE) single-center, clinical trial. A total of 100 patients with ACS undergoing drug-eluting stent implantation will be randomly assigned to prasugrel, ticagrelor, or clopidogrel, and the patients in each treatment group will receive 1-month therapy with 100 mg q.d. aspirin plus prasugrel 10 mg q.d., ticagrelor 90 mg b.i.d., or clopidogrel 75 mg q.d., followed by half-dose prasugrel 5 mg q.d. or ticagrelor 45 mg b.i.d. for maintenance treatment but without clopidogrel dose reduction. The primary endpoint will be optimal platelet reactivity 3 months after coronary intervention, defined by VerifyNow Analyzer (PRU: 85-208) and vasodilator-stimulated phosphoprotein P2Y12 flow cytometry assay (platelet reactivity indices: 16-50%). Clinical outcomes will also be assessed, including major efficacy (composite of cardiac death, nonfatal myocardial infarction, repeat revascularization, or stroke) and safety (bleeding ≥2 according to the Bleeding Academic Research Consortium). HOPE-TAILOR is a prospective, randomized, open-label, blinded, endpoint study to explore the efficacy and safety of novel P2Y12 receptor inhibitors administered orally at half the dose in Korean patients with ACS. The results will be available late in 2017. © 2017 S. Karger AG, Basel.

Reinforcement sensitivity theory and alcohol outcome expectancies in early adolescence.

PubMed

Lopez-Vergara, Hector I; Colder, Craig R; Hawk, Larry W; Wieczorek, William F; Eiden, Rina D; Lengua, Liliana J; Read, Jennifer P

2012-03-01

Little research has examined the development of alcohol expectancies in childhood, a notable omission as expectancies are viable targets for prevention programs. Moreover, limited alcohol expectancies research has been conducted from the perspective of psychobiological models of motivation despite the strong conceptual links between such models and cognitive models of alcohol use. To examine if the associations between individual differences from the revised reinforcement sensitivity theory (Gray JA, McNaughton N. The Neuropsychology of Anxiety: An Enquiry into the Functions of the Septo-hippocampal System (2nd ed.). Oxford, UK: Oxford University Press, 2000) and alcohol use is mediated by alcohol expectancies in a large community sample of early adolescents using a prospective design. 378 families (1 caregiver; 1 child) were recruited via random digit phone call using a prospective design. Our findings suggest that both a strong behavioral approach system and fight-flight or freeze system were associated with high levels of positive outcome expectancies, which subsequently predicted an increase in likelihood of alcohol use. There was also some evidence that drive (an aspect of behavioral approach system) was also positively associated with negative expectancies, which subsequently predicted a low probability of alcohol use. Individual differences in reinforcement sensitivity may influence the acquisition of positive and negative outcome expectancies, thereby potentially influencing the likelihood of alcohol use in early adolescence. Thus, reinforcement sensitivity theory is a promising theory to account for the link between neural models of addiction and early acquisition of alcohol use in humans.

Call-related factors influencing output power from mobile phones.

PubMed

Hillert, Lena; Ahlbom, Anders; Neasham, David; Feychting, Maria; Järup, Lars; Navin, Roshan; Elliott, Paul

2006-11-01

Mobile phone use is increasing but there is also concern for adverse health effects. Well-designed prospective studies to assess several health outcomes are required. In designing a study of mobile phone use, it is important to assess which factors need to be considered in classifying the exposure to radiofrequency fields (RF). A pilot study was performed in Sweden and in the UK 2002 to 2003 to test the feasibility of recruiting a cohort of mobile phone users from a random population sample and from mobile phone subscription lists for a prospective study. As one part of this pilot study, different factors were evaluated regarding possible influence on the output power of the phones. By local switch logging, information on calls made from predefined subscriptions or dedicated handsets were obtained and the output power of phones during calls made indoors and outdoors, in moving and stationary mode, and in rural as well in urban areas were compared. In this experiment, calls were either 1, 1.5 or 5 min long. The results showed that high mobile phone output power is more frequent in rural areas whereas the other factors (length of call, moving/stationary, indoor/outdoor) were of less importance. Urban and rural area should be considered in an exposure index for classification of the exposure to RF from mobile phones and may be assessed by first base station during mobile phone calls or, if this information is not available, possibly by using home address as a proxy.

Pilot study assessing the feasibility of applying bilateral subthalamic nucleus deep brain stimulation in very early stage Parkinson's disease: study design and rationale.

PubMed

Charles, David; Tolleson, Christopher; Davis, Thomas L; Gill, Chandler E; Molinari, Anna L; Bliton, Mark J; Tramontana, Michael G; Salomon, Ronald M; Kao, Chris; Wang, Lily; Hedera, Peter; Phibbs, Fenna T; Neimat, Joseph S; Konrad, Peter E

2012-01-01

Deep brain stimulation provides significant symptomatic benefit for people with advanced Parkinson's disease whose symptoms are no longer adequately controlled with medication. Preliminary evidence suggests that subthalamic nucleus stimulation may also be efficacious in early Parkinson's disease, and results of animal studies suggest that it may spare dopaminergic neurons in the substantia nigra. We report the methodology and design of a novel Phase I clinical trial testing the safety and tolerability of deep brain stimulation in early Parkinson's disease and discuss previous failed attempts at neuroprotection. We recently conducted a prospective, randomized, parallel-group, single-blind pilot clinical trial of deep brain stimulation in early Parkinson's disease. Subjects were randomized to receive either optimal drug therapy or deep brain stimulation plus optimal drug therapy. Follow-up visits occurred every six months for a period of two years and included week-long therapy washouts. Thirty subjects with Hoehn & Yahr Stage II idiopathic Parkinson's disease were enrolled over a period of 32 months. Twenty-nine subjects completed all follow-up visits; one patient in the optimal drug therapy group withdrew from the study after baseline. Baseline characteristics for all thirty patients were not significantly different. This study demonstrates that it is possible to recruit and retain subjects in a clinical trial testing deep brain stimulation in early Parkinson's disease. The results of this trial will be used to support the design of a Phase III, multicenter trial investigating the efficacy of deep brain stimulation in early Parkinson's disease.

Pilot Study Assessing the Feasibility of Applying Bilateral Subthalamic Nucleus Deep Brain Stimulation in Very Early Stage Parkinson's Disease: Study design and rationale

PubMed Central

Charles, David; Tolleson, Christopher; Davis, Thomas L.; Gill, Chandler E.; Molinari, Anna L.; Bliton, Mark J.; Tramontana, Michael G.; Salomon, Ronald M.; Kao, Chris; Wang, Lily; Hedera, Peter; Phibbs, Fenna T.; Neimat, Joseph S.; Konrad, Peter E.

2014-01-01

Background Deep brain stimulation provides significant symptomatic benefit for people with advanced Parkinson's disease whose symptoms are no longer adequately controlled with medication. Preliminary evidence suggests that subthalamic nucleus stimulation may also be efficacious in early Parkinson's disease, and results of animal studies suggest that it may spare dopaminergic neurons in the substantia nigra. Objective We report the methodology and design of a novel Phase I clinical trial testing the safety and tolerability of deep brain stimulation in early Parkinson's disease and discuss previous failed attempts at neuroprotection. Methods We recently conducted a prospective, randomized, parallel-group, single-blind pilot clinical trial of deep brain stimulation in early Parkinson's disease. Subjects were randomized to receive either optimal drug therapy or deep brain stimulation plus optimal drug therapy. Follow-up visits occurred every six months for a period of two years and included week-long therapy washouts. Results Thirty subjects with Hoehn & Yahr Stage II idiopathic Parkinson's disease were enrolled over a period of 32 months. Twenty-nine subjects completed all follow-up visits; one patient in the optimal drug therapy group withdrew from the study after baseline. Baseline characteristics for all thirty patients were not significantly different. Conclusions This study demonstrates that it is possible to recruit and retain subjects in a clinical trial testing deep brain stimulation in early Parkinson's disease. The results of this trial will be used to support the design of a Phase III, multicenter trial investigating the efficacy of deep brain stimulation in early Parkinson's disease. PMID:23938229

The Convergence Insufficiency Treatment Trial: Design, Methods, and Baseline Data

PubMed Central

2009-01-01

Objective This report describes the design and methodology of the Convergence Insufficiency Treatment Trial (CITT), the first large-scale, placebo-controlled, randomized clinical trial evaluating treatments for convergence insufficiency (CI) in children. We also report the clinical and demographic characteristics of patients. Methods We prospectively randomized children 9 to 17 years of age to one of four treatment groups: 1) home-based pencil push-ups, 2) home-based computer vergence/accommodative therapy and pencil push-ups, 3) office-based vergence/accommodative therapy with home reinforcement, 4) office-based placebo therapy. Outcome data on the Convergence Insufficiency Symptom Survey (CISS) score (primary outcome), near point of convergence (NPC), and positive fusional vergence were collected after 12 weeks of active treatment and again at 6 and 12 months post-treatment. Results The CITT enrolled 221 children with symptomatic CI with a mean age of 12.0 years (SD = +2.3). The clinical profile of the cohort at baseline was 9Δ exophoria at near (+/− 4.4) and 2Δ exophoria (+/−2.8) at distance, CISS score = 30 (+/−9.0), NPC = 14 cm (+/− 7.5), and near positive fusional vergence break = 13 Δ (+/− 4.6). There were no statistically significant nor clinically relevant differences between treatment groups with respect to baseline characteristics (p > 0.05). Conclusion Hallmark features of the study design include formal definitions of conditions and outcomes, standardized diagnostic and treatment protocols, a placebo treatment arm, masked outcome examinations, and the CISS score outcome measure. The baseline data reported herein define the clinical profile of those enrolled into the CITT. PMID:18300086

Rationale and design of A Trial of Sertraline vs. Cognitive Behavioral Therapy for End-stage Renal Disease Patients with Depression (ASCEND).

PubMed

Hedayati, S Susan; Daniel, Divya M; Cohen, Scott; Comstock, Bryan; Cukor, Daniel; Diaz-Linhart, Yaminette; Dember, Laura M; Dubovsky, Amelia; Greene, Tom; Grote, Nancy; Heagerty, Patrick; Katon, Wayne; Kimmel, Paul L; Kutner, Nancy; Linke, Lori; Quinn, Davin; Rue, Tessa; Trivedi, Madhukar H; Unruh, Mark; Weisbord, Steven; Young, Bessie A; Mehrotra, Rajnish

2016-03-01

Major Depressive Disorder (MDD) is highly prevalent in patients with End Stage Renal Disease (ESRD) treated with maintenance hemodialysis (HD). Despite the high prevalence and robust data demonstrating an independent association between depression and poor clinical and patient-reported outcomes, MDD is under-treated when identified in such patients. This may in part be due to the paucity of evidence confirming the safety and efficacy of treatments for depression in this population. It is also unclear whether HD patients are interested in receiving treatment for depression. ASCEND (Clinical Trials Identifier Number NCT02358343), A Trial of Sertraline vs. Cognitive Behavioral Therapy (CBT) for End-stage Renal Disease Patients with Depression, was designed as a multi-center, 12-week, open-label, randomized, controlled trial of prevalent HD patients with comorbid MDD or dysthymia. It will compare (1) a single Engagement Interview vs. a control visit for the probability of initiating treatment for comorbid depression in up to 400 patients; and (2) individual chair-side CBT vs. flexible-dose treatment with a selective serotonin reuptake inhibitor, sertraline, for improvement of depressive symptoms in 180 of the up to 400 patients. The evolution of depressive symptoms will also be examined in a prospective longitudinal cohort of 90 HD patients who choose not to be treated for depression. We discuss the rationale and design of ASCEND, the first large-scale randomized controlled trial evaluating efficacy of non-pharmacologic vs. pharmacologic treatment of depression in HD patients for patient-centered outcomes. Published by Elsevier Inc.

Rationale and Design of A Trial of Sertraline vs. Cognitive Behavioral Therapy for End-stage Renal Disease Patients with Depression (ASCEND)

PubMed Central

Hedayati, S. Susan; Daniel, Divya M.; Cohen, Scott; Comstock, Bryan; Cukor, Daniel; Diaz-Linhart, Yaminette; Dember, Laura M.; Dubovsky, Amelia; Greene, Tom; Grote, Nancy; Heagerty, Patrick; Katon, Wayne; Kimmel, Paul L.; Kutner, Nancy; Linke, Lori; Quinn, Davin; Rue, Tessa; Trivedi, Madhukar H.; Unruh, Mark; Weisbord, Steven; Young, Bessie A.; Mehrotra, Rajnish

2015-01-01

Major Depressive Disorder (MDD) is highly prevalent in patients with End Stage Renal Disease (ESRD) treated with maintenance hemodialysis (HD). Despite the high prevalence and robust data demonstrating an independent association between depression and poor clinical and patient-reported outcomes, MDD is under-treated when identified in such patients. This may in part be due to the paucity of evidence confirming the safety and efficacy of treatments for depression in this population. It is also unclear whether HD patients are interested in receiving treatment for depression. ASCEND (Clinical Trials Identifier Number NCT02358343), A Trial of Sertraline vs. Cognitive Behavioral Therapy (CBT) for End-stage Renal Disease Patients with Depression, was designed as a multi-center, 12-week, open-label, randomized, controlled trial of prevalent HD patients with comorbid MDD or dysthymia. It will compare (1) a single Engagement Interview vs. a control visit for the probability of initiating treatment for comorbid depression in up to 400 patients; and (2) individual chair-side CBT vs. flexible-dose treatment with a selective serotonin reuptake inhibitor, sertraline, for improvement of depressive symptoms in 180 of the up to 400 patients. The evolution of depressive symptoms will also be examined in a prospective longitudinal cohort of 90 HD patients who choose not to be treated for depression. We discuss the rationale and design of ASCEND, the first large-scale randomized controlled trial evaluating efficacy of non-pharmacologic vs. pharmacologic treatment of depression in HD patients for patient-centered outcomes. PMID:26621218

The convergence insufficiency treatment trial: design, methods, and baseline data.

PubMed

2008-01-01

This report describes the design and methodology of the Convergence Insufficiency Treatment Trial (CITT), the first large-scale, placebo-controlled, randomized clinical trial evaluating treatments for convergence insufficiency (CI) in children. We also report the clinical and demographic characteristics of patients. We prospectively randomized children 9 to 17 years of age to one of four treatment groups: 1) home-based pencil push-ups, 2) home-based computer vergence/accommodative therapy and pencil push-ups, 3) office-based vergence/accommodative therapy with home reinforcement, 4) office-based placebo therapy. Outcome data on the Convergence Insufficiency Symptom Survey (CISS) score (primary outcome), near point of convergence (NPC), and positive fusional vergence were collected after 12 weeks of active treatment and again at 6 and 12 months posttreatment. The CITT enrolled 221 children with symptomatic CI with a mean age of 12.0 years (SD = +2.3). The clinical profile of the cohort at baseline was 9Delta exophoria at near (+/- 4.4) and 2Delta exophoria (+/-2.8) at distance, CISS score = 30 (+/-9.0), NPC = 14 cm (+/- 7.5), and near positive fusional vergence break = 13 Delta (+/- 4.6). There were no statistically significant nor clinically relevant differences between treatment groups with respect to baseline characteristics (p > 0.05). Hallmark features of the study design include formal definitions of conditions and outcomes, standardized diagnostic and treatment protocols, a placebo treatment arm, masked outcome examinations, and the CISS score outcome measure. The baseline data reported herein define the clinical profile of those enrolled into the CITT.

Behavior management for children and adolescents with acquired brain injury.

PubMed

Slifer, Keith J; Amari, Adrianna

2009-01-01

Behavioral problems such as disinhibition, irritability, restlessness, distractibility, and aggression are common after acquired brain injury (ABI). The persistence and severity of these problems impair the brain-injured individual's reintegration into family, school, and community life. Since the early 1980s, behavior analysis and therapy have been used to address the behavioral sequelae of ABI. These interventions are based on principles of learning and behavior that have been robustly successful when applied across a broad range of other clinical populations. Most of the research on behavioral treatment after ABI has involved clinical case studies or studies employing single-subject experimental designs across a series of cases. The literature supports the effectiveness of these interventions across ages, injury severities, and stages of recovery after ABI. Recommended guidelines for behavior management include: direct behavioral observations, systematic assessment of environmental and within-patient variables associated with aberrant behavior, antecedent management to minimize the probability of aberrant behavior, provision of functionally equivalent alternative means of controlling the environment, and differential reinforcement to shape positive behavior and coping strategies while not inadvertently shaping emergent, disruptive sequelae. This package of interventions requires direction by a highly skilled behavioral psychologist or therapist who systematically monitors target behavior to evaluate progress and guide treatment decisions. A coordinated multisite effort is needed to design intervention protocols that can be studied prospectively in randomized controlled trials. However, there will continue to be an important role for single subject experimental design for studying the results of individualized interventions and obtaining pilot data to guide subsequent randomized controlled trails. (c) 2009 Wiley-Liss, Inc.

Alternatives for randomization in lifestyle intervention studies in cancer patients were not better than conventional randomization.

PubMed

Velthuis, Miranda J; May, Anne M; Monninkhof, Evelyn M; van der Wall, Elsken; Peeters, Petra H M

2012-03-01

Assessing effects of lifestyle interventions in cancer patients has some specific challenges. Although randomization is urgently needed for evidence-based knowledge, sometimes it is difficult to apply conventional randomization (i.e., consent preceding randomization and intervention) in daily settings. Randomization before seeking consent was proposed by Zelen, and additional modifications were proposed since. We discuss four alternatives for conventional randomization: single and double randomized consent design, two-stage randomized consent design, and the design with consent to postponed information. We considered these designs when designing a study to assess the impact of physical activity on cancer-related fatigue and quality of life. We tested the modified Zelen design with consent to postponed information in a pilot. The design was chosen to prevent drop out of participants in the control group because of disappointment about the allocation. The result was a low overall participation rate most likely because of perceived lack of information by eligible patients and a relatively high dropout in the intervention group. We conclude that the alternatives were not better than conventional randomization. Copyright © 2012 Elsevier Inc. All rights reserved.

Dissociable Effects of Subthalamic Stimulation in Obsessive Compulsive Disorder on Risky Reward and Loss Prospects.

PubMed

Voon, Valerie; Droux, Fabien; Chabardes, Stephan; Bougerol, Thierry; Kohl, Sina; David, Olivier; Krack, Paul; Polosan, Mircea

2018-07-01

Our daily decisions involve an element of risk, a behavioral process that is potentially modifiable. Here we assess the role of the associative-limbic subthalamic nucleus (STN) in obsessive compulsive disorder (OCD) testing on and off deep-brain stimulation (DBS) on anticipatory risk taking to obtain rewards and avoid losses. We assessed 12 OCD STN DBS in a randomized double-blind within-subject cross-over design. STN DBS decreased risk taking to rewards (p = 0.02) and greater risk taking to rewards was positively correlated with OCD severity (p = 0.01) and disease duration (p = 0.01). STN DBS was also associated with impaired subjective discrimination of loss magnitude (p < 0.05), an effect mediated by acute DBS rather than chronic DBS. We highlight a role for the STN in mediating dissociable valence prospects on risk seeking. STN stimulation decreases risk taking to rewards and impairs discrimination of loss magnitude. These findings may have implications for behavioral symptoms related to STN DBS and the potential for STN DBS for the treatment of psychiatric disorders. Copyright © 2018. Published by Elsevier Ltd.

Promoting participation in physical activity using framed messages: an application of prospect theory.

PubMed

Latimer, Amy E; Rench, Tara A; Rivers, Susan E; Katulak, Nicole A; Materese, Stephanie A; Cadmus, Lisa; Hicks, Althea; Keany Hodorowski, Julie; Salovey, Peter

2008-11-01

Messages designed to motivate participation in physical activity usually emphasize the benefits of physical activity (gain-framed) as well as the costs of inactivity (loss-framed). The framing implications of prospect theory suggest that the effectiveness of these messages could be enhanced by providing gain-framed information only. We compared the effectiveness of gain-, loss-, and mixed-framed messages for promoting moderate to vigorous physical activity. Randomized trial. Sedentary, healthy callers to the US National Cancer Institute's Cancer Information Service (N=322) received gain-, loss-, or mixed-framed messages on three occasions (baseline, Week 1, and Week 5). Social cognitive variables and self-reported physical activity were assessed at baseline, Week 2, and Week 9. Separate regression analyses were conducted to examine message effects at each assessment point. At Week 2, gain- and mixed-framed messages resulted in stronger intentions and greater self-efficacy than loss-framed messages. At Week 9, gain-framed messages resulted in greater physical activity participation than loss- or mixed-framed messages. Social cognitive variables at Week 2 did not mediate the Week 9 framing effects on physical activity participation. Using gain-framed messages exclusively may be a means of increasing the efficacy of physical activity materials.

Efficacy of Eight Months of Nightly Zolpidem: A Prospective Placebo-Controlled Study

PubMed Central

Randall, Surilla; Roehrs, Timothy A.; Roth, Thomas

2012-01-01

Study Objectives: To evaluate the long-term (8 months) efficacy of zolpidem in adults with chronic primary insomnia using polysomnography. Design: Randomized, double-blind, placebo-controlled clinical trial. Setting: Sleep disorders and research center. Participants: Healthy participants (n = 91), ages 23-70, meeting DSM-IV-TR criteria for primary insomnia. Interventions: Nightly zolpidem, 10 mg (5 mg for patients > 60 yrs) or placebo 30 minutes before bedtime for 8 months. Measurements and Results: Polysomnographic sleep parameters and morning subject assessments of sleep on 2 nights in months 1 and 8. Relative to placebo, zolpidem significantly increased overall total sleep time and sleep efficiency, reduced sleep latency and wake after sleep onset when assessed at months 1 and 8. Overall, subjective evaluations of efficacy were not shown among treatment groups. Conclusions: In adults with primary insomnia, nightly zolpidem administration remained efficacious across 8 months of nightly use. Clinical Trial Information: ClinicalTrials.gov Identifier: NCT01006525; Trial Name: Safety and Efficacy of Chronic Hypnotic Use; http://clinicaltrials.gov/ct2/show/NCT01006525. Citation: Randall S; Roehrs TA; Roth T. Efficacy of eight months of nightly zolpidem: a prospective placebo-controlled study. SLEEP 2012;35(11):1551-1557. PMID:23115404

The IDEA (International Duration Evaluation of Adjuvant Chemotherapy) Collaboration: Prospective Combined Analysis of Phase III Trials Investigating Duration of Adjuvant Therapy with the FOLFOX (FOLFOX4 or Modified FOLFOX6) or XELOX (3 versus 6 months) Regimen for Patients with Stage III Colon Cancer: Trial Design and Current Status.

PubMed

André, Thierry; Iveson, Timothy; Labianca, Roberto; Meyerhardt, Jeffrey A; Souglakos, Ioannis; Yoshino, Takayuki; Paul, James; Sobrero, Alberto; Taieb, Julien; Shields, Anthony F; Ohtsu, Atsushi; Grothey, Axel; Sargent, Daniel J

2013-01-01

The International Duration Evaluation of Adjuvant Chemotherapy (IDEA) collaboration was established to prospectively combine and analyze data from several randomized trials conducted around the world to answer whether a three-month course of oxaliplatin-based adjuvant therapy (FOLFOX4/modified FOLFOX6 or XELOX) is non-inferior to the current standard six-month treatment for patients with stage III colon cancer, with a primary endpoint of three years disease-free survival. The IDEA steering committee comprises two members from each group coordinating an individual trial and two members from a secretariat who coordinate combining of the data and management of the joint analysis. Members of the IDEA agreed to combine the data from their individual trials to enable definitive analysis consisting of at least 10,500 patients. With accrual of 8,797 patients at the end of February 2013, the IDEA is on track to achieve its accrual objective of at least 10,500 patients by the end of 2013.

Meta-analysis of neutropenia or leukopenia as a prognostic factor in patients with malignant disease undergoing chemotherapy.

PubMed

Shitara, Kohei; Matsuo, Keitaro; Oze, Isao; Mizota, Ayako; Kondo, Chihiro; Nomura, Motoo; Yokota, Tomoya; Takahari, Daisuke; Ura, Takashi; Muro, Kei

2011-08-01

We performed a systematic review and meta-analysis to determine the impact of neutropenia or leukopenia experienced during chemotherapy on survival. Eligible studies included prospective or retrospective analyses that evaluated neutropenia or leukopenia as a prognostic factor for overall survival or disease-free survival. Statistical analyses were conducted to calculate a summary hazard ratio and 95% confidence interval (CI) using random-effects or fixed-effects models based on the heterogeneity of the included studies. Thirteen trials were selected for the meta-analysis, with a total of 9,528 patients. The hazard ratio of death was 0.69 (95% CI, 0.64-0.75) for patients with higher-grade neutropenia or leukopenia compared to patients with lower-grade or lack of cytopenia. Our analysis was also stratified by statistical method (any statistical method to decrease lead-time bias; time-varying analysis or landmark analysis), but no differences were observed. Our results indicate that neutropenia or leukopenia experienced during chemotherapy is associated with improved survival in patients with advanced cancer or hematological malignancies undergoing chemotherapy. Future prospective analyses designed to investigate the potential impact of chemotherapy dose adjustment coupled with monitoring of neutropenia or leukopenia on survival are warranted.

Critical thinking and reflection exercises in a biochemistry course to improve prospective health professions students' attitudes toward physician-pharmacist collaboration.

PubMed

Van Winkle, Lon J; Cornell, Susan; Fjortoft, Nancy; Bjork, Bryan C; Chandar, Nalini; Green, Jacalyn M; La Salle, Sophie; Viselli, Susan M; Burdick, Paulette; Lynch, Sean M

2013-10-14

To determine the impact of performing critical-thinking and reflection assignments within interdisciplinary learning teams in a biochemistry course on pharmacy students' and prospective health professions students' collaboration scores. Pharmacy students and prospective medical, dental, and other health professions students enrolled in a sequence of 2 required biochemistry courses. They were randomly assigned to interdisciplinary learning teams in which they were required to complete case assignments, thinking and reflection exercises, and a team service-learning project. Students were asked to complete the Scale of Attitudes Toward Physician-Pharmacist Collaboration prior to the first course, following the first course, and following the second course. The physician-pharmacist collaboration scores of prospective health professions students increased significantly (p<0.001). Having prospective health professions students work in teams with pharmacy students to think and reflect in and outside the classroom improves their attitudes toward physician-pharmacist collaboration.

Rationale and design of the MONITOR-ICD study: a randomized comparison of economic and clinical effects of automatic remote MONITORing versus control in patients with Implantable Cardioverter Defibrillators.

PubMed

Zabel, Markus; Müller-Riemenschneider, Falk; Geller, J Christoph; Brachmann, Johannes; Kühlkamp, Volker; Dissmann, Rüdiger; Reinhold, Thomas; Roll, Stephanie; Lüthje, Lars; Bode, Frank; Eckardt, Lars; Willich, Stefan N

2014-10-01

Implantable cardioverter defibrillator (ICD) remote follow-up and ICD remote monitoring (RM) are established means of ICD follow-up. The reduction of the number of in-office visits and the time to decision is proven, but the true clinical benefit is still unknown. Cost and cost-effectiveness of RM remain leading issues for its dissemination. The MONITOR-ICD study has been designed to assess costs, cost-effectiveness, and clinical benefits of RM versus standard-care follow-up in a prospective multicenter randomized controlled trial. Patients indicated for single- or dual-chamber ICD are eligible for the study and are implanted an RM-capable Biotronik ICD (Lumax VR-T or Lumax DR-T; Biotronik SE & Co KG, Berlin, Germany). Implantable cardioverter defibrillator programming and alert-based clinical responses in the RM group are highly standardized by protocol. As of December 2011, recruitment has been completed, and 416 patients have been enrolled. Subjects are followed-up for a minimum of 12months and a maximum of 24months, ending in January 2013. Disease-specific costs from a societal perspective have been defined as primary end point and will be compared between RM and standard-care groups. Secondary end points include ICD shocks (including appropriate and inappropriate shocks), cardiovascular hospitalizations and cardiovascular mortality, and additional health economic end points. The MONITOR-ICD study will be an important randomized RM study to report data on a primary economic end point in 2014. Its results on ICD shocks will add to the currently available evidence on clinical benefit of RM. Copyright © 2014 Mosby, Inc. All rights reserved.

Myocardial perfusion 320-row multidetector computed tomography-guided treatment strategy for the clinical management of patients with recent acute-onset chest pain: Design of the CArdiac cT in the treatment of acute CHest pain (CATCH)-2 randomized controlled trial.

PubMed

Sørgaard, Mathias; Linde, Jesper J; Hove, Jens D; Petersen, Jan R; Jørgensen, Tem B S; Abdulla, Jawdat; Heitmann, Merete; Kragelund, Charlotte; Hansen, Thomas Fritz; Udholm, Patricia M; Pihl, Christian; Kühl, J Tobias; Engstrøm, Thomas; Jensen, Jan Skov; Høfsten, Dan E; Kelbæk, Henning; Kofoed, Klaus F

2016-09-01

Patients admitted with chest pain are a diagnostic challenge because the majority does not have coronary artery disease (CAD). Assessment of CAD with coronary computed tomography angiography (CCTA) is safe, cost-effective, and accurate, albeit with a modest specificity. Stress myocardial computed tomography perfusion (CTP) has been shown to increase the specificity when added to CCTA, without lowering the sensitivity. This article describes the design of a randomized controlled trial, CATCH-2, comparing a clinical diagnostic management strategy of CCTA alone against CCTA in combination with CTP. Patients with acute-onset chest pain older than 50 years and with at least one cardiovascular risk factor for CAD are being prospectively enrolled to this study from 6 different clinical sites since October 2013. A total of 600 patients will be included. Patients are randomized 1:1 to clinical management based on CCTA or on CCTA in combination with CTP, determining the need for further testing with invasive coronary angiography including measurement of the fractional flow reserve in vessels with coronary artery lesions. Patients are scanned with a 320-row multidetector computed tomography scanner. Decisions to revascularize the patients are taken by the invasive cardiologist independently of the study allocation. The primary end point is the frequency of revascularization. Secondary end points of clinical outcome are also recorded. The CATCH-2 will determine whether CCTA in combination with CTP is diagnostically superior to CCTA alone in the management of patients with acute-onset chest pain. Copyright © 2015 Elsevier Inc. All rights reserved.

A web-based personalized risk communication and decision-making tool for women with dense breasts: Design and methods of a randomized controlled trial within an integrated health care system.

PubMed

Knerr, Sarah; Wernli, Karen J; Leppig, Kathleen; Ehrlich, Kelly; Graham, Amanda L; Farrell, David; Evans, Chalanda; Luta, George; Schwartz, Marc D; O'Neill, Suzanne C

2017-05-01

Mammographic breast density is one of the strongest risk factors for breast cancer after age and family history. Mandatory breast density disclosure policies are increasing nationally without clear guidance on how to communicate density status to women. Coupling density disclosure with personalized risk counseling and decision support through a web-based tool may be an effective way to allow women to make informed, values-consistent risk management decisions without increasing distress. This paper describes the design and methods of Engaged, a prospective, randomized controlled trial examining the effect of online personalized risk counseling and decision support on risk management decisions in women with dense breasts and increased breast cancer risk. The trial is embedded in a large integrated health care system in the Pacific Northwest. A total of 1250 female health plan members aged 40-69 with a recent negative screening mammogram who are at increased risk for interval cancer based on their 5-year breast cancer risk and BI-RADS® breast density will be randomly assigned to access either a personalized web-based counseling and decision support tool or standard educational content. Primary outcomes will be assessed using electronic health record data (i.e., chemoprevention and breast MRI utilization) and telephone surveys (i.e., distress) at baseline, six weeks, and twelve months. Engaged will provide evidence about whether a web-based personalized risk counseling and decision support tool is an effective method for communicating with women about breast density and risk management. An effective intervention could be disseminated with minimal clinical burden to align with density disclosure mandates. Clinical Trials Registration Number:NCT03029286. Copyright © 2017 Elsevier Inc. All rights reserved.

Designing a definitive trial for adjuvant targeted therapy in genotype defined lung cancer: the ALCHEMIST trials.

PubMed

Alden, Ryan S; Mandrekar, Sumithra J; Oxnard, Geoffrey R

2015-09-01

Genotype-directed targeted therapies have revolutionized the treatment of metastatic non-small cell lung cancer (NSCLC) but they have not yet been comprehensively studied in the adjuvant setting. Previous trials of adjuvant targeted therapy in unselected early stage NSCLC patients showed no benefit versus placebo, however retrospective data suggests improved disease free survival (DFS) with epidermal growth factor receptor (EGFR) inhibitors in patients with appropriate molecular alterations. A definitive prospective, randomized, placebo-controlled trial of targeted therapies for NSCLC is needed to determine the efficacy of targeted therapy following surgical resection and standard adjuvant therapy. The principal challenges facing such a trial are (I) identification of actionable alterations in early stage patients; and (II) realization of sufficient enrollment to power definitive analyses. The ALCHEMIST trial (Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial) was designed to overcome these challenges. Using the national clinical trials network (NCTN) of the National Cancer Institute (NCI), several thousand patients with operable NSCLC will undergo tumor genotyping for EGFR mutations or rearrangement of anaplastic lymphoma kinase (ALK). Following resection and completion of standard adjuvant therapy, patients with EGFR-mutant NSCLC will be randomized to erlotinib versus placebo (1:1), those with ALK-rearranged NSCLC will be randomized to crizotinib versus placebo (1:1), while those not enrolled onto the adjuvant trials will continue to be followed on the screening trial. ALCHEMIST also provides for the collection of tissue at baseline and at recurrence (if available) to characterize mechanisms of recurrence and of resistance to targeted therapy. Thus, ALCHEMIST is a platform for validation of targeted therapy as part of curative care in NSCLC and creates an opportunity to advance our understanding of disease biology.

Calorie Restriction in Overweight SeniorS: Response of Older Adults to a Dieting Study: The CROSSROADS Randomized Controlled Clinical Trial

PubMed Central

Haas, Marilyn C.; Bodner, Eric V.; Brown, Cynthia J.; Bryan, David; Buys, David R.; Keita, Akilah Dulin; Flagg, Lee Anne; Goss, Amy; Gower, Barbara; Hovater, Martha; Hunter, Gary; Ritchie, Christine S.; Roth, David L.; Wingo, Brooks C.; Ard, Jamy; Locher, Julie L.

2014-01-01

We conducted a study designed to evaluate whether the benefits of intentional weight loss exceed the potential risks in a group of community-dwelling, obese, older adults who were at increased risk for cardiometabolic disease. The CROSSROADS trial used a prospective randomized controlled design to compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition and adipose tissue deposition (Specific Aim #1: To compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition, namely visceral adipose tissue (VAT)), cardiometabolic disease risk (Specific Aim #2: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on cardiometabolic disease risk), functional status and quality of life (Specific Aim #3: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on functional status and quality of life). Participants were randomly assigned to one of three groups: Exercise Only (Control) Intervention, Exercise + Diet Quality + Weight Maintenance Intervention, or Exercise + Diet Quality + Weight Loss Intervention. CROSSROADS utilized a lifestyle intervention approach consisting of exercise, dietary, and behavioral components. The development and implementation of the CROSSROADS protocol, including a description of the methodology, detailing specific elements of the lifestyle intervention, assurances of treatment fidelity, and participant retention; outcome measures and adverse event monitoring; as well as unique data management features of the trial results, are presented in this article. PMID:25424512

Calorie restriction in overweight seniors: response of older adults to a dieting study: the CROSSROADS randomized controlled clinical trial.

PubMed

Haas, Marilyn C; Bodner, Eric V; Brown, Cynthia J; Bryan, David; Buys, David R; Keita, Akilah Dulin; Flagg, Lee Anne; Goss, Amy; Gower, Barbara; Hovater, Martha; Hunter, Gary; Ritchie, Christine S; Roth, David L; Wingo, Brooks C; Ard, Jamy; Locher, Julie L

2014-01-01

We conducted a study designed to evaluate whether the benefits of intentional weight loss exceed the potential risks in a group of community-dwelling obese older adults who were at increased risk for cardiometabolic disease. The CROSSROADS trial used a prospective randomized controlled design to compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition and adipose tissue deposition (Specific Aim #1: To compare the effects of changes in diet composition alone or combined with weight loss with an exercise only control intervention on body composition, namely visceral adipose tissue), cardiometabolic disease risk (Specific Aim #2: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on cardiometabolic disease risk), and functional status and quality of life (Specific Aim #3: To compare the effects of a change in diet composition alone or combined with weight loss with an exercise only control intervention on functional status and quality of life). Participants were randomly assigned to one of three groups: Exercise Only (Control) Intervention, Exercise + Diet Quality + Weight Maintenance Intervention, or Exercise + Diet Quality + Weight Loss Intervention. CROSSROADS utilized a lifestyle intervention approach consisting of exercise, dietary, and behavioral components. The development and implementation of the CROSSROADS protocol, including a description of the methodology, detailing specific elements of the lifestyle intervention, assurances of treatment fidelity, and participant retention; outcome measures and adverse event monitoring; as well as unique data management features of the trial results, are presented in this article.

Study design and rationale of the 'Balloon-Expandable Cobalt Chromium SCUBA Stent versus Self-Expandable COMPLETE-SE Nitinol Stent for the Atherosclerotic ILIAC Arterial Disease (SENS-ILIAC Trial) Trial': study protocol for a randomized controlled trial.

PubMed

Choi, Woong Gil; Rha, Seung Woon; Choi, Cheol Ung; Kim, Eung Ju; Oh, Dong Joo; Cho, Yoon Hyung; Park, Sang Ho; Lee, Seung Jin; Hur, Ae Yong; Ko, Young Guk; Park, Sang Min; Kim, Ki Chang; Kim, Joo Han; Kim, Min Woong; Kim, Sang Min; Bae, Jang Ho; Bong, Jung Min; Kang, Won Yu; Seo, Jae Bin; Jung, Woo Yong; Cho, Jang Hyun; Kim, Do Hoi; Ahn, Ji Hoon; Kim, Soo Hyun; Jang, Ji Yong

2016-06-25

The self-expandable COMPLETE™ stent (Medtronic) has greater elasticity, allowing it to regain its shape after the compression force reduces, and has higher trackability, thus is easier to maneuver through tortuous vessels, whereas the balloon-expandable SCUBA™ stent (Medtronic) has higher radial stiffness and can afford more accurate placement without geographic miss, which is important in aortoiliac bifurcation lesions. To date, there have been no randomized control trials comparing efficacy and safety between the self-expanding stent and balloon-expandable stent in advanced atherosclerotic iliac artery disease. The purpose of our study is to examine primary patency (efficacy) and incidence of stent fracture and geographic miss (safety) between two different major representative stents, the self-expanding nitinol stent (COMPLETE-SE™) and the balloon-expanding cobalt-chromium stent (SCUBA™), in stenotic or occlusive iliac arterial lesions. This trial is designed as a prospective, randomized, multicenter trial to demonstrate a noninferiority of SCUBA™ stent to COMPLETE-SE™ stent following balloon angioplasty in iliac arterial lesions, and a total of 280 patients will be enrolled. The primary end point of this study is the rate of primary patency in the treated segment at 12 months after intervention as determined by catheter angiography, computed tomography angiography, or duplex ultrasound. The SENS-ILIAC trial will give powerful insight into whether the stent choice according to deployment mechanics would impact stent patency, geographic miss, or stent fracture in patients undergoing stent implantation in iliac artery lesions. National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier: NCT01834495 ), registration date: May 8, 2012.

Antibiotics in third molar extraction; are they really necessary: A non-inferiority randomized controlled trial

PubMed Central

Arora, Ankit; Roychoudhury, Ajoy; Bhutia, Ongkila; Pandey, Sandeep; Singh, Surender; Das, Bimal K.

2014-01-01

Introduction: Antibiotic resistance is now a serious problem, although it was not so only a few years ago. The need of the hour is to give clear evidence of the efficacy of antibiotic use, or lack thereof, to the surgeon for a procedure as common as mandibular third molar surgery. Aim: This study aimed to evaluate whether postoperative combined amoxicillin and clavulanic acid in mandibular third molar extraction is effective in preventing inflammatory complications. Study and Design: The study was structured as a prospective randomized double-blind placebo-controlled clinical trial. Materials and Methods: A study was designed wherein the 96 units (two bilaterally similar impacted mandibular third molars per head in 48 patients) were randomly assigned to two treatment groups (Group I and Group II). Each patient served as his/her own control. Each patient received 625 mg of combined amoxicillin and clavulanic acid 1 h before surgery. In the case of third molars belonging to Group I, 625 mg of combined amoxicillin and clavulanic acid TDS was continued for 3 days; in Group II, placebo in similar-looking packs was continued for 3 days. The patients were evaluated on the third and seventh postoperative days for signs of clinical infection and for microbial load evaluation. Statistical Analysis: The data between the two groups were statistically analyzed by the two-tailed Fisher's exact test, with a 95% confidence interval. Results: The difference was not statistically significant between the test group and the control group with regard to erythema, dehiscence, swelling, pain, trismus, and infection based on microbial load. The data were statistically significant for alveolar osteitis, with the occurrence of alveolar osteitis (14.58%) in the placebo group. Conclusion: Postoperative antibiotics are recommended only for patients undergoing contaminated, long-duration surgery. PMID:25937728

Rationale, design and baseline characteristics of a randomized controlled trial of a web-based computer-tailored physical activity intervention for adults from Quebec City.

PubMed

Boudreau, François; Walthouwer, Michel Jean Louis; de Vries, Hein; Dagenais, Gilles R; Turbide, Ginette; Bourlaud, Anne-Sophie; Moreau, Michel; Côté, José; Poirier, Paul

2015-10-09

The relationship between physical activity and cardiovascular disease (CVD) protection is well documented. Numerous factors (e.g. patient motivation, lack of facilities, physician time constraints) can contribute to poor PA adherence. Web-based computer-tailored interventions offer an innovative way to provide tailored feedback and to empower adults to engage in regular moderate- to vigorous-intensity PA. To describe the rationale, design and content of a web-based computer-tailored PA intervention for Canadian adults enrolled in a randomized controlled trial (RCT). 244 men and women aged between 35 and 70 years, without CVD or physical disability, not participating in regular moderate- to vigorous-intensity PA, and familiar with and having access to a computer at home, were recruited from the Quebec City Prospective Urban and Rural Epidemiological (PURE) study centre. Participants were randomized into two study arms: 1) an experimental group receiving the intervention and 2) a waiting list control group. The fully automated web-based computer-tailored PA intervention consists of seven 10- to 15-min sessions over an 8-week period. The theoretical underpinning of the intervention is based on the I-Change Model. The aim of the intervention was to reach a total of 150 min per week of moderate- to vigorous-intensity aerobic PA. This study will provide useful information before engaging in a large RCT to assess the long-term participation and maintenance of PA, the potential impact of regular PA on CVD risk factors and the cost-effectiveness of a web-based computer-tailored intervention. ISRCTN36353353 registered on 24/07/2014.

Optimal global value of information trials: better aligning manufacturer and decision maker interests and enabling feasible risk sharing.

PubMed

Eckermann, Simon; Willan, Andrew R

2013-05-01

Risk sharing arrangements relate to adjusting payments for new health technologies given evidence of their performance over time. Such arrangements rely on prospective information regarding the incremental net benefit of the new technology, and its use in practice. However, once the new technology has been adopted in a particular jurisdiction, randomized clinical trials within that jurisdiction are likely to be infeasible and unethical in the cases where they would be most helpful, i.e. with current evidence of positive while uncertain incremental health and net monetary benefit. Informed patients in these cases would likely be reluctant to participate in a trial, preferring instead to receive the new technology with certainty. Consequently, informing risk sharing arrangements within a jurisdiction is problematic given the infeasibility of collecting prospective trial data. To overcome such problems, we demonstrate that global trials facilitate trialling post adoption, leading to more complete and robust risk sharing arrangements that mitigate the impact of costs of reversal on expected value of information in jurisdictions who adopt while a global trial is undertaken. More generally, optimally designed global trials offer distinct advantages over locally optimal solutions for decision makers and manufacturers alike: avoiding opportunity costs of delay in jurisdictions that adopt; overcoming barriers to evidence collection; and improving levels of expected implementation. Further, the greater strength and translatability of evidence across jurisdictions inherent in optimal global trial design reduces barriers to translation across jurisdictions characteristic of local trials. Consequently, efficiently designed global trials better align the interests of decision makers and manufacturers, increasing the feasibility of risk sharing and the expected strength of evidence over local trials, up until the point that current evidence is globally sufficient.

Could Fractional Exhaled Nitric Oxide Test be Useful in Predicting Inhaled Corticosteroid Responsiveness in Chronic Cough? A Systematic Review.

PubMed

Song, Woo-Jung; Won, Ha-Kyeong; Moon, Sung-Do; Chung, Soo-Jie; Kang, Sung-Yoon; Sohn, Kyoung-Hee; Kim, Ju-Young; Kim, Byung-Keun; Lim, Kyung-Hwan; Kim, Mi-Yeong; Yang, Min-Suk; Park, Heung-Woo; Chang, Yoon-Seok; Lee, Byung-Jae; Morice, Alyn H; Cho, Sang-Heon

Fractional exhaled nitric oxide (Feno) is a safe and convenient test for assessing T H 2 airway inflammation, which is potentially useful in the management of patients with chronic cough. To summarize the current evidence on the diagnostic usefulness of Feno for predicting inhaled corticosteroid (ICS) responsiveness in patients with chronic cough. A systematic literature review was conducted to identify articles published in peer-reviewed journals up to February 2015, without language restriction. We included studies that reported the usefulness of Feno (index test) for predicting ICS responsiveness (reference standard) in patients with chronic cough (target condition). The data were extracted to construct a 2 × 2 accuracy table. Study quality was assessed with Quality Assessment of Diagnostic Accuracy Studies 2. We identified 5 original studies (2 prospective and 3 retrospective studies). We identified considerable heterogeneities in study design and outcome definitions, and thus were unable to perform a meta-analysis. The proportion of ICS responders ranged from 44% to 59%. Sensitivity and specificity ranged from 53% to 90%, and from 63% to 97%, respectively. The reported area under the curve ranged from about 0.60 to 0.87; however, studies with a prospective design and a lower prevalence of asthma had lower area under the curve values. None measured placebo effects or objective cough frequency. We did not find strong evidence to support the use of Feno tests for predicting ICS responsiveness in chronic cough. Further studies need to have a randomized, placebo-controlled design, and should use validated measurement tools for cough. Standardization would facilitate the development of clinical evidence. Copyright © 2016. Published by Elsevier Inc.

The Statistical Power of the Cluster Randomized Block Design with Matched Pairs--A Simulation Study

ERIC Educational Resources Information Center

Dong, Nianbo; Lipsey, Mark

2010-01-01

This study uses simulation techniques to examine the statistical power of the group- randomized design and the matched-pair (MP) randomized block design under various parameter combinations. Both nearest neighbor matching and random matching are used for the MP design. The power of each design for any parameter combination was calculated from…

Mobile Health Technology for Atrial Fibrillation Management Integrating Decision Support, Education, and Patient Involvement: mAF App Trial.

PubMed

Guo, Yutao; Chen, Yundai; Lane, Deirdre A; Liu, Lihong; Wang, Yutang; Lip, Gregory Y H

2017-12-01

Mobile Health technology for the management of patients with atrial fibrillation is unknown. The simple mobile AF (mAF) App was designed to incorporate clinical decision-support tools (CHA 2 DS 2 -VASc [Congestive heart failure, Hypertension, Age ≥75 years, Diabetes Mellitus, Prior Stroke or TIA, Vascular disease, Age 65-74 years, Sex category], HAS-BLED [Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly, Drugs/alcohol concomitantly], SAMe-TT 2 R 2 [Sex, Age <60 years, Medical history, Treatment, Tobacco use, Race] scores), educational materials, and patient involvement strategies with self-care protocols and structured follow-up. Patients with atrial fibrillation were randomized into 2 groups (mAF App vs usual care) in a cluster randomized design pilot study. Patients' knowledge, quality of life, drug adherence, and anticoagulation satisfaction were evaluated at baseline, 1 month, and 3 months. Usability, feasibility, and acceptability of the mAF App were assessed at 1 month. A total of 113 patients were randomized to mAF App intervention (mean age, 67.4 years; 57.5% were male; mean follow-up, 69 days), and 96 patients were randomized to usual care (mean age, 70.9 years; 55.2% were male; mean follow-up, 95 days). More than 90% of patients reported that the mAF App was easy, user-friendly, helpful, and associated with significant improvements in knowledge compared with the usual care arm (P values for trend <.05). Drug adherence and anticoagulant satisfaction were significantly better with the mAF App versus usual care (all P < .05). Quality of life scores were significantly increased in the mAF App arm versus usual care, with anxiety and depression reduced (all P < .05). The pilot mAFA Trial is the first prospective randomized trial of Mobile Health technology in patients with atrial fibrillation, demonstrating that the mAF App, integrating clinical decision support, education, and patient-involvement strategies, significantly improved knowledge, drug adherence, quality of life, and anticoagulation satisfaction. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: study protocol for a randomized controlled trial.

PubMed

Crétel-Durand, Elodie; Nouguerède, Emilie; Le Caer, Hervé; Rousseau, Frédérique; Retornaz, Frédérique; Guillem, Olivier; Couderc, Anne-Laure; Greillier, Laurent; Norguet, Emmanuelle; Cécile, Maud; Boulahssass, Rabia; Le Caer, Francoise; Tournier, Sandrine; Butaud, Chantal; Guillet, Pierre; Nahon, Sophie; Poudens, Laure; Kirscher, Sylvie; Loubière, Sandrine; Diaz, Nadine; Dhorne, Jean; Auquier, Pascal; Baumstarck, Karine

2017-04-12

Cancer incidence and social isolation increase along with advanced age, and social isolation potentiates the relative risk of death by cancer. Once spotted, social isolation can be averted with the intervention of a multidisciplinary team. Techniques of automation and remote assistance have already demonstrated their positive impact on falls prevention and quality of life (QoL), though little is known about their impact on socially isolated elderly patients supported for cancer. The primary objective of the PREDOMOS study is to evaluate the impact of establishing a Program of Social intervention associated with techniques of Domotic and Remote assistance (PS-DR) on the improvement of QoL of elderly isolated patients, treated for locally advanced or metastatic cancer. The secondary objectives include treatment failure, tolerance, survival, and autonomy. This trial is a multicenter, prospective, randomized, placebo-controlled, open-label, two-parallel group study. The setting is 10 French oncogeriatric centers. Inclusion criteria are patients aged at least 70 years with a social isolation risk and a histological diagnosis of cancer, locally advanced or metastatic disease. The groups are (1) the control group, receiving usual care; (2) the experimental group, receiving usual care associating with monthly social assistance, domotic, and remote assistance. Participants are randomized in a 1:1 allocation ratio. Evaluation times involve inclusion (randomization) and follow-up (12 months). The primary endpoint is QoL at 3 months (via European Organization for Research and Treatment of Cancer (EORTC) QLQ C30); secondary endpoints are social isolation, time to treatment failure, toxicity, dose response-intensity, survival, autonomy, and QoL at 6 months. For the sample size, 320 individuals are required to obtain 90% power to detect a 10-point difference (standard deviation 25) in QoL score between the two groups (20% loss to follow-up patients expected). The randomized controlled design is the most appropriate design to demonstrate the efficacy of a new experimental strategy (Evidence-Based Medicine Working Group classification). National and international recommendations could be updated based on the findings of this study. ClinicalTrials.gov, NCT02829762 . Registered on 29 June 2016.

Adolescent depressive disorders and family based interventions in the Family Options multicenter evaluation: study protocol for a randomized controlled trial.

PubMed

Lewis, Andrew J; Bertino, Melanie D; Skewes, Joanna; Shand, Lyndel; Borojevic, Nina; Knight, Tess; Lubman, Dan I; Toumbourou, John W

2013-11-13

There is increasing community and government recognition of the magnitude and impact of adolescent depression. Family based interventions have significant potential to address known risk factors for adolescent depression and could be an effective way of engaging adolescents in treatment. The evidence for family based treatments of adolescent depression is not well developed. The objective of this clinical trial is to determine whether a family based intervention can reduce rates of unipolar depressive disorders in adolescents, improve family functioning and engage adolescents who are reluctant to access mental health services. The Family Options study will determine whether a manualized family based intervention designed to target both individual and family based factors in adolescent depression (BEST MOOD) will be more effective in reducing unipolar depressive disorders than an active (standard practice) control condition consisting of a parenting group using supportive techniques (PAST). The study is a multicenter effectiveness randomized controlled trial. Both interventions are delivered in group format over eight weekly sessions, of two hours per session. We will recruit 160 adolescents (12 to 18 years old) and their families, randomized equally to each treatment condition. Participants will be assessed at baseline, eight weeks and 20 weeks. Assessment of eligibility and primary outcome will be conducted using the KID-SCID structured clinical interview via adolescent and parent self-report. Assessments of family mental health, functioning and therapeutic processes will also be conducted. Data will be analyzed using Multilevel Mixed Modeling accounting for time x treatment effects and random effects for group and family characteristics. This trial is currently recruiting. Challenges in design and implementation to-date are discussed. These include diagnosis and differential diagnosis of mental disorders in the context of adolescent development, non-compliance of adolescents with requirements of assessment, questionnaire completion and treatment attendance, breaking randomization, and measuring the complexity of change in the context of a family-based intervention. Australia and New Zealand Clinical Trials Registry Title: engaging youth with high prevalence mental health problems using family based interventions; number 12612000398808. Prospectively registered on 10 April 2012.

A long and winding road; evolution of antimicrobial drug development - crisis management.

PubMed

Echols, Roger M

2012-11-01

The development of antimicrobial drugs has evolved from observational case reports to complex randomized prospective clinical trials in specific treatment indications. Beginning around the year 2000, the US FDA has evolved its approach on study design and other study characteristics, which has made the conduct of these studies more difficult and the outcomes for sponsors more risky. This has contributed to the decline in the discovery and development of new antimicrobials, which are needed to address the increasing problem of bacterial resistance to existing marketed products. This study reviews the historical basis for the current regulatory climate including the various crises that have led to considerable political pressures on the agency. Recent efforts to resolve development uncertainties and to provide economic incentives for future antimicrobial drug development are presented.

Ductal carcinoma in situ: USC/Van Nuys Prognostic Index and the impact of margin status.

PubMed

Silverstein, Melvin J; Buchanan, Claire

2003-12-01

As our knowledge of ductal carcinoma in situ (DCIS) continues to evolve, treatment decision-making has become increasingly complex and controversial for both patients and physicians. Treatment options include mastectomy, and breast conservation with or without radiation therapy. Data produced from the randomized clinical trials for DCIS has provided the basis for important treatment recommendations, but are not without limitations. In this article, we review our prospectively collected database consisting of 1036 patients with DCIS treated at the Van Nuys Breast Center and the USC/Norris Comprehensive Cancer Center. We review the use of the USC/Van Nuys Prognostic Index, a clinical algorithm designed to assist physicians in selection of appropriate treatments, and examine the impact of margin status as a sole predictor of local recurrence.

A Prospective Study Investigating Pre-diagnostic Leukocyte Telomere Length and Risk of Developing Rheumatoid Arthritis in Women

PubMed Central

Prescott, Jennifer; Karlson, Elizabeth W.; Orr, Esther H.; Zee, Robert Y.L.; De Vivo, Immaculata; Costenbader, Karen H.

2015-01-01

Objective To prospectively examine the association between leukocyte telomere length (LTL) and subsequent RA development in women. Methods Using a case-control design nested within the prospective Nurses’ Health Study (NHS), Nurses’ Health Study II (NHSII), and Women’s Health Study (WHS), each validated case of RA with a pre-diagnostic blood sample was matched to three controls by cohort, age, menopausal status, postmenopausal hormone therapy, and blood collection covariates. We measured telomere length in genomic DNA extracted from stored buffy coat samples using quantitative PCR. We used unconditional logistic regression to determine odds ratios (OR) and 95% confidence intervals (CI), and random-effects meta-analysis to combine study results. Results In total, we analyzed 296 incident RA cases and 827 matched controls. Mean age of diagnosis among women who developed RA was 60.5 in NHS/NHSII and 61.3 in WHS. Meta-analysis demonstrated that longer pre-diagnostic LTL was associated with increased RA risk when women in the longest vs. shortest LTL tertile were compared (OR=1.51, 95% CI=1.03–2.23; pheterogeneity=0.27). However, statistically significant between study heterogeneity was observed for the intermediate tertile category (pheterogeneity=0.008). We did not observe heterogeneity by menopausal status, inflammatory cytokine levels, age at diagnosis, age at blood collection, body mass index, seropositivity, or HLA-DRB1 shared epitope status. Conclusion Our results do not support a role for short LTL preceding RA development. PMID:26773113

Randomizing Roaches: Exploring the "Bugs" of Randomization in Experimental Design

ERIC Educational Resources Information Center

Wagler, Amy; Wagler, Ron

2014-01-01

Understanding the roles of random selection and random assignment in experimental design is a central learning objective in most introductory statistics courses. This article describes an activity, appropriate for a high school or introductory statistics course, designed to teach the concepts, values and pitfalls of random selection and assignment…

Refining Preoperative Therapy for Locally Advanced Rectal Cancer

Cancer.gov

In the PROSPECT trial, patients with locally advanced, resectable rectal cancer will be randomly assigned to receive either standard neoadjuvant chemoradiation therapy or neoadjuvant FOLFOX chemotherapy, with chemoradiation reserved for nonresponders.

Prospective, Randomized, Multi-centered Clinical Trial Assessing Safety and Efficacy of a Synthetic Cartilage Implant Versus First Metatarsophalangeal Arthrodesis in Advanced Hallux Rigidus.

PubMed

Baumhauer, Judith F; Singh, Dishan; Glazebrook, Mark; Blundell, Chris; De Vries, Gwyneth; Le, Ian L D; Nielsen, Dominic; Pedersen, M Elizabeth; Sakellariou, Anthony; Solan, Matthew; Wansbrough, Guy; Younger, Alastair S E; Daniels, Timothy

2016-05-01

Although a variety of great toe implants have been tried in an attempt to maintain toe motion, the majority have failed with loosening, malalignment/dislocation, implant fragmentation and bone loss. In these cases, salvage to arthrodesis is more complicated and results in shortening of the ray or requires structural bone graft to reestablish length. This prospective study compared the efficacy and safety of this small (8/10 mm) hydrogel implant to the gold standard of a great toe arthrodesis for advanced-stage hallux rigidus. In this prospective, randomized non-inferiority study, patients from 12 centers in Canada and the United Kingdom were randomized (2:1) to a synthetic cartilage implant or first metatarsophalangeal (MTP) joint arthrodesis. VAS pain scale, validated outcome measures (Foot and Ankle Ability Measure [FAAM] sport scale), great toe active dorsiflexion motion, secondary procedures, radiographic assessment, and safety parameters were evaluated. Analysis was performed using intent-to-treat (ITT) and modified ITT (mITT) methodology. The primary endpoint for the study consisted of a single composite endpoint using the 3 primary study outcomes (pain, function, and safety). The individual subject's outcome was considered a success if all of the following criteria were met: (1) improvement (decrease) from baseline in VAS pain of ≥30% at 12 months; (2) maintenance of function from baseline in FAAM sports subscore at 12 months; and (3) absence of major safety events at 2 years. The proportion of successes in each group was determined and 1-sided 95% confidence interval for the difference between treatment groups was calculated. Noninferiority of the implant to arthrodesis was considered statistically significant if the 1-sided 95% lower confidence interval was greater than the equivalence limit (<15%). A total of 236 patients were initially enrolled; 17 patients withdrew prior to randomization, 17 patients withdrew after randomization, and 22 were nonrandomized training patients, leaving 152 implant and 50 arthrodesis patients. Standard demographics and baseline outcomes were similar for both groups. VAS pain scores decreased significantly in both the implant and arthrodesis groups from baseline at 12 and 24 months. Similarly, the FAAM sports and activity of daily living subscores improved significantly at 12 and 24 months in both groups. First MTP active dorsiflexion motion improvement was 6.2 degrees (27.3%) after implant placement and was maintained at 24 months. Subsequent secondary surgeries occurred in 17 (11.2%) implant patients (17 procedures) and 6 (12.0%) arthrodesis patients (7 procedures). Fourteen (9.2%) implants were removed and converted to arthrodesis, and 6 (12.0%) arthrodesis patients (7 procedures [14%]) had isolated screws or plate and screw removal. There were no cases of implant fragmentation, wear, or bone loss. When analyzing the ITT and mITT population for the primary composite outcome of VAS pain, function (FAAM sports), and safety, there was statistical equivalence between the implant and arthrodesis groups. A prospective, randomized (2:1), controlled, noninferiority clinical trial was performed to compare the safety and efficacy of a small synthetic cartilage bone implant to first MTP arthrodesis in patients with advanced-stage hallux rigidus. This study showed equivalent pain relief and functional outcomes. The synthetic implant was an excellent alternative to arthrodesis in patients who wished to maintain first MTP motion. The percentage of secondary surgical procedures was similar between groups. Less than 10% of the implant group required revision to arthrodesis at 2 years. Level I, prospective randomized study. © The Author(s) 2016.

Risk and Protective Factors for Intimate Partner Violence Against Women: Systematic Review and Meta-analyses of Prospective-Longitudinal Studies.

PubMed

Yakubovich, Alexa R; Stöckl, Heidi; Murray, Joseph; Melendez-Torres, G J; Steinert, Janina I; Glavin, Calla E Y; Humphreys, David K

2018-07-01

The estimated lifetime prevalence of physical or sexual intimate partner violence (IPV) is 30% among women worldwide. Understanding risk and protective factors is essential for designing effective prevention strategies. To quantify the associations between prospective-longitudinal risk and protective factors and IPV and identify evidence gaps. We conducted systematic searches in 16 databases including MEDLINE and PsycINFO from inception to June 2016. The study protocol is registered with PROSPERO (CRD42016039213). We included published and unpublished studies available in English that prospectively analyzed any risk or protective factor(s) for self-reported IPV victimization among women and controlled for at least 1 other variable. Three reviewers were involved in study screening. One reviewer extracted estimates of association and study characteristics from each study and 2 reviewers independently checked a random subset of extractions. We assessed study quality with the Cambridge Quality Checklists. When studies investigated the same risk or protective factor using similar measures, we computed pooled odds ratios (ORs) by using random-effects meta-analyses. We summarized heterogeneity with I 2 and τ 2 . We synthesized all estimates of association, including those not meta-analyzed, by using harvest plots to illustrate evidence gaps and trends toward negative or positive associations. Of 18 608 studies identified, 60 were included and 35 meta-analyzed. Most studies were based in the United States. The strongest evidence for modifiable risk factors for IPV against women were unplanned pregnancy (OR = 1.66; 95% confidence interval [CI] = 1.20, 1.31) and having parents with less than a high-school education (OR = 1.55; 95% CI = 1.10, 2.17). Being older (OR = 0.96; 95% CI = 0.93, 0.98) or married (OR = 0.93; 95% CI = 0.87, 0.99) were protective. To our knowledge, this is the first systematic, meta-analytic review of all risk and protective factors for IPV against women without location, time, or publication restrictions. Unplanned pregnancy and having parents with less than a high-school education, which may indicate lower socioeconomic status, were shown to be risk factors, and being older or married were protective. However, no prospective-longitudinal study investigated the associations between IPV against women and any community or structural factor outside the United States, and more studies investigated risk factors related to women as opposed to their partners. Public health implications. This review highlights that prospective evidence for perpetrator- and context-related risk and protective factors for women's experiences of IPV outside of the United States is lacking and urgently needed to inform global policy recommendations. The current evidence base of prospective studies suggests that, at least in the United States, education and sexual health interventions may be effective targets for preventing IPV against women, with young, unmarried women at greatest risk.

The hemodynamic effects of intravenous paracetamol (acetaminophen) vs normal saline in cardiac surgery patients: A single center placebo controlled randomized study

PubMed Central

Churilov, Leonid

2018-01-01

The hemodynamic effects of intravenous (IV) paracetamol in patients undergoing cardiac surgery are unknown. We performed a prospective single center placebo controlled randomized study with parallel group design in adult patients undergoing elective cardiac surgery. Participants received paracetamol (1 gram) IV or placebo (an equal volume of 0.9% saline) preoperatively followed by two postoperative doses 6 hours apart. The primary endpoint was the absolute change in systolic (SBP) 30 minutes after the preoperative infusion, analysed using an ANCOVA model. Secondary endpoints included absolute changes in mean arterial pressure (MAP) and diastolic blood pressure (DPB), and other key hemodynamic variables after each infusion. All other endpoints were analysed using random-effect generalized least squares regression modelling with individual patients treated as random effects. Fifty participants were randomly assigned to receive paracetamol (n = 25) or placebo (n = 25). Post preoperative infusion, paracetamol decreased SBP by a mean (SD) of 13 (18) mmHg, p = 0.02, compared to a mean (SD) of 1 (11) mmHg with saline. Paracetamol decreased MAP and DBP by a mean (SD) of 9 (12) mmHg and 8 (9) mmHg (p = 0.01 and 0.02), respectively, compared to a mean (SD) of 1 (8) mmHg and 0 (6) mmHg with placebo. Postoperatively, there were no significant differences in pressure or flow based hemodynamic parameters in both groups. This study provides high quality evidence that the administration of IV paracetamol in patients undergoing cardiac surgery causes a transient decrease in preoperative blood pressure when administered before surgery but no adverse hemodynamic effects when administered in the postoperative setting. PMID:29659631

Sequenced treatment alternatives to relieve depression (STAR*D): rationale and design.

PubMed

Rush, A John; Fava, Maurizio; Wisniewski, Stephen R; Lavori, Philip W; Trivedi, Madhukar H; Sackeim, Harold A; Thase, Michael E; Nierenberg, Andrew A; Quitkin, Frederic M; Kashner, T Michael; Kupfer, David J; Rosenbaum, Jerrold F; Alpert, Jonathan; Stewart, Jonathan W; McGrath, Patrick J; Biggs, Melanie M; Shores-Wilson, Kathy; Lebowitz, Barry D; Ritz, Louise; Niederehe, George

2004-02-01

STAR*D is a multisite, prospective, randomized, multistep clinical trial of outpatients with nonpsychotic major depressive disorder. The study compares various treatment options for those who do not attain a satisfactory response with citalopram, a selective serotonin reuptake inhibitor antidepressant. The study enrolls 4000 adults (ages 18-75) from both primary and specialty care practices who have not had either a prior inadequate response or clear-cut intolerance to a robust trial of protocol treatments during the current major depressive episode. After receiving citalopram (level 1), participants without sufficient symptomatic benefit are eligible for randomization to level 2 treatments, which entail four switch options (sertraline, bupropion, venlafaxine, cognitive therapy) and three citalopram augment options (bupropion, buspirone, cognitive therapy). Those who receive cognitive therapy (switch or augment options) at level 2 without sufficient improvement are eligible for randomization to one of two level 2A switch options (venlafaxine or bupropion). Level 2 and 2A participants are eligible for random assignment to two switch options (mirtazapine or nortriptyline) and to two augment options (lithium or thyroid hormone) added to the primary antidepressant (citalopram, bupropion, sertraline, or venlafaxine) (level 3). Those without sufficient improvement at level 3 are eligible for level 4 random assignment to one of two switch options (tranylcypromine or the combination of mirtazapine and venlafaxine). The primary outcome is the clinician-rated, 17-item Hamilton Rating Scale for Depression, administered at entry and exit from each treatment level through telephone interviews by assessors masked to treatment assignments. Secondary outcomes include self-reported depressive symptoms, physical and mental function, side-effect burden, client satisfaction, and health care utilization and cost. Participants with an adequate symptomatic response may enter the 12-month naturalistic follow-up phase with brief monthly and more complete quarterly assessments.

The hemodynamic effects of intravenous paracetamol (acetaminophen) vs normal saline in cardiac surgery patients: A single center placebo controlled randomized study.

PubMed

Chiam, Elizabeth; Bellomo, Rinaldo; Churilov, Leonid; Weinberg, Laurence

2018-01-01

The hemodynamic effects of intravenous (IV) paracetamol in patients undergoing cardiac surgery are unknown. We performed a prospective single center placebo controlled randomized study with parallel group design in adult patients undergoing elective cardiac surgery. Participants received paracetamol (1 gram) IV or placebo (an equal volume of 0.9% saline) preoperatively followed by two postoperative doses 6 hours apart. The primary endpoint was the absolute change in systolic (SBP) 30 minutes after the preoperative infusion, analysed using an ANCOVA model. Secondary endpoints included absolute changes in mean arterial pressure (MAP) and diastolic blood pressure (DPB), and other key hemodynamic variables after each infusion. All other endpoints were analysed using random-effect generalized least squares regression modelling with individual patients treated as random effects. Fifty participants were randomly assigned to receive paracetamol (n = 25) or placebo (n = 25). Post preoperative infusion, paracetamol decreased SBP by a mean (SD) of 13 (18) mmHg, p = 0.02, compared to a mean (SD) of 1 (11) mmHg with saline. Paracetamol decreased MAP and DBP by a mean (SD) of 9 (12) mmHg and 8 (9) mmHg (p = 0.01 and 0.02), respectively, compared to a mean (SD) of 1 (8) mmHg and 0 (6) mmHg with placebo. Postoperatively, there were no significant differences in pressure or flow based hemodynamic parameters in both groups. This study provides high quality evidence that the administration of IV paracetamol in patients undergoing cardiac surgery causes a transient decrease in preoperative blood pressure when administered before surgery but no adverse hemodynamic effects when administered in the postoperative setting.

The FIND-CKD study--a randomized controlled trial of intravenous iron versus oral iron in non-dialysis chronic kidney disease patients: background and rationale.

PubMed

Macdougall, Iain C; Bock, Andreas; Carrera, Fernando; Eckardt, Kai-Uwe; Gaillard, Carlo; Van Wyck, David; Roubert, Bernard; Cushway, Timothy; Roger, Simon D

2014-04-01

Rigorous data are sparse concerning the optimal route of administration and dosing strategy for iron therapy with or without concomitant erythropoiesis-stimulating agent (ESA) therapy for the management of iron deficiency anaemia in patients with non-dialysis dependent chronic kidney disease (ND-CKD). FIND-CKD was a 56-week, open-label, multicentre, prospective, randomized three-arm study (NCT00994318) of 626 patients with ND-CKD and iron deficiency anaemia randomized to (i) intravenous (IV) ferric carboxymaltose (FCM) at an initial dose of 1000 mg iron with subsequent dosing as necessary to target a serum ferritin level of 400-600 µg/L (ii) IV FCM at an initial dose of 200 mg with subsequent dosing as necessary to target serum ferritin 100-200 µg/L or (iii) oral ferrous sulphate 200 mg iron/day. The primary end point was time to initiation of other anaemia management (ESA therapy, iron therapy other than study drug or blood transfusion) or a haemoglobin (Hb) trigger (two consecutive Hb values <10 g/dL without an increase of ≥ 0.5 g/dL). The background, rationale and study design of the trial are presented here. The study has been completed and results are expected in late 2013. FIND-CKD was the longest randomized trial of IV iron therapy to date. Its findings will address several unanswered questions regarding iron therapy to treat iron deficiency anaemia in patients with ND-CKD. It was also the first randomized trial to utilize both a high and low serum ferritin target range to adjust IV iron dosing, and the first not to employ Hb response as its primary end point.

Finding atrial fibrillation in stroke patients: Randomized evaluation of enhanced and prolonged Holter monitoring--Find-AF(RANDOMISED) --rationale and design.

PubMed

Weber-Krüger, Mark; Gelbrich, Götz; Stahrenberg, Raoul; Liman, Jan; Kermer, Pawel; Hamann, Gerhard F; Seegers, Joachim; Gröschel, Klaus; Wachter, Rolf

2014-10-01

Detecting paroxysmal atrial fibrillation (AF) in patients with ischemic strokes presenting in sinus rhythm is challenging because episodes are often short, occur randomly, and are frequently asymptomatic. If AF is detected, recurrent thromboembolism can be prevented efficiently by oral anticoagulation. Numerous uncontrolled studies using various electrocardiogram (ECG) devices have established that prolonged ECG monitoring increases the yield of AF detection, but most established procedures are time-consuming and costly. The few randomized trials are mostly limited to cryptogenic strokes. The optimal method, duration, and patient selection remain unclear. Repeated prolonged continuous Holter ECG monitoring to detect paroxysmal AF within an unspecific stroke population may prove to be a widely applicable, effective secondary prevention strategy. Find-AFRANDOMISED is a randomized and controlled prospective multicenter trial. Four hundred patients 60 years or older with manifest (symptoms ≥24 hours or acute computed tomography/magnetic resonance imaging lesion) and acute (symptoms ≤7 days) ischemic strokes will be included at 4 certified stroke centers in Germany. Those with previously diagnosed AF/flutter, indications/contraindications for oral anticoagulation, or obvious causative blood vessel pathologies will be excluded. Patients will be randomized 1:1 to either enhanced and prolonged Holter ECG monitoring (10 days at baseline and after 3 and 6 months) or standard of care (≥24-hour continuous ECG monitoring, according to current stroke guidelines). All patients will be followed up for at least 12 months. The primary end point is newly detected AF (≥30 seconds) after 6 months, confirmed by an independent adjudication committee. We plan to complete recruitment in autumn 2014. First results can be expected by spring 2016. Copyright © 2014 Mosby, Inc. All rights reserved.

Systematic review and meta-analysis of secondary prophylaxis for prevention of HIV-related toxoplasmic encephalitis relapse using trimethoprim-sulfamethoxazole.

PubMed

Connolly, Mark P; Haitsma, Gertruud; Hernández, Adrián V; Vidal, José E

2017-09-01

A recent systematic literature and meta-analysis reported relative efficacy of trimethoprim-sulfamethoxazole (TMP-SMX) for the treatment of toxoplasmic encephalitis (TE) in HIV-infected adults. Here, we estimated relapse rates during secondary prophylaxis with TMP-SMX, and further explored differences in relapse rates prior to introduction of highly active antiretroviral therapy (HAART) and the widespread adoption of HAART. A systematic search of PubMed, Embase, and Cochrane Central Register of Controlled Trials yielded 707 studies whereby 663 were excluded after abstract screening, and 38 were excluded after full review leaving 6 studies for extraction. We performed double data extraction with a third-party adjudicator. Study designs varied with only one randomized study, four prospective cohorts and one retrospective cohort. Relapse rates were transformed using the Freeman-Tukey method and pooled using both fixed-effect and random-effects meta-analysis models. The TMP-SMX relapse rate was 16.4% (95% CI = 6.2% to 30.3%) based on random-effects models. When the disaggregated pre-HAART studies (n = 4) were included, the relapse rate was 14.9% (random effects; 95% CI = 3.7% to 31.9%). Analysis of two post-HAART studies indicated a relapse rate of 19.2% (random effects; 95% CI = 2.8% to 45.6%). Comparing the relapse rates between pre- and post-HAART studies were contrary to what might be expected based on known benefits of HAART therapy in this population. Nevertheless, cautious interpretation is necessary considering the heterogeneity of the included studies and a limited number of subjects receiving TMP-SMX reported in the post-HAART era.

Is instillation of anesthetic gel necessary in flexible cystoscopic examination? A prospective randomized study.

PubMed

Kobayashi, Takashi; Nishizawa, Koji; Ogura, Keiji

2003-01-01

To determine whether urethral injection of anesthetic and lubricating agent before outpatient flexible cystoscopic examination is worthwhile regarding patient tolerance of pain. A randomized prospective study was conducted. A total of 133 consecutive men scheduled to undergo flexible cystoscopy were randomized to receive 11 mL of 0.2% oxybuprocaine hydrochloride gel (group 1), 11 mL of plain lubricating gel (group 2), or no gel injection (group 3). In every group, 2% lidocaine gel was applied to the fiberscope. Patients recorded the level of pain during gel instillation, scope insertion, and intravesical observation separately on a 100-mm visual analog self-assessment scale. Pain scores for gel instillation were approximately two thirds those for scope insertion and intravesical observation in groups 1 and 2. No significant difference was noted in the pain score of each group during either scope insertion or intravesical observation. Pain during intraurethral gel instillation is significant. Anesthetic gel instillation has no advantage compared with no-gel injection in men when lubricating gel is applied to a flexible fiberscope.

Clinical and electrophysiologic results after intracameral lidocaine 1% anesthesia: a prospective randomized study.

PubMed

Anders, N; Heuermann, T; Rüther, K; Hartmann, C

1999-10-01

To evaluate the efficacy and safety of intracameral lidocaine in cataract surgery compared to peribulbar anesthesia. A prospective, randomized, controlled study. A total of 200 consecutive cataract patients (200 eyes) participated. Eyes were randomly assigned to two groups: one group received 0.15 ml intracameral 1% unpreserved lidocaine combined with topical anesthesia (oxybuprocaine); the other group received 6 ml prilocaine peribulbar before phacoemulsification with sclerocorneal tunnel incision. Duration of surgery was measured; implicit time and amplitudes of the b-waves of the photopic electroretinogram (ERG) potentials (single-flash ERG and the 30-Hz flicker ERG) were recorded; frequencies of intraoperative problems, complications, intraoperative, and postoperative pain were evaluated. After lidocaine anesthesia combined with topical anesthesia, similar complications were found, longer operation time (P < 0.001), and significantly better visual acuity immediately after surgery (P < 0.001). The ERG amplitudes were not significantly reduced after 0.15-ml intracameral lidocaine half an hour after surgery (P > 0.05). Intracameral lidocaine 1% combined with topical anesthesia can be recommended as an alternative procedure to peribulbar anesthesia in cataract surgery with corneoscleral tunnel incision.

Randomized prospective trial of ganciclovir maintenance therapy for cytomegalovirus retinitis.

PubMed

Jacobson, M A; O'Donnell, J J; Brodie, H R; Wofsy, C; Mills, J

1988-07-01

We report the first randomized prospective comparative study of long-term maintenance ganciclovir (9-[2-hydroxy-1-(hydroxymethyl)ethoxymethyl]guanine, BW759U, DHPG) therapy for cytomegalovirus retinitis in patients with the acquired immunodeficiency syndrome (AIDS). Eleven retinitis patients who received a 10-day course of ganciclovir induction therapy and then were randomized to receive either immediate daily ganciclovir maintenance therapy or deferred maintenance (eight deferred maintenance, three immediate maintenance) were evaluated for drug efficacy. Median time to retinitis progression was 42 days for the immediate maintenance group compared with 16 days for the deferred maintenance group, (P = 0.07). After crossing over to maintenance therapy, patients in the deferred group had a median time to retinitis progression of 58 days compared to 16 days while not on maintenance therapy (P = 0.13). Only 9% of cultures obtained while patients received maintenance therapy were positive for cytomegalovirus, vs 40% of those obtained off maintenance (P less than 0.001). We can state then that maintenance therapy with ganciclovir delays, but does not halt, progression of cytomegalovirus retinitis and suppresses, but does not eradicate, cytomegalovirus shedding in patients with AIDS.

Comparison of torsional and microburst longitudinal phacoemulsification: a prospective, randomized, masked clinical trial.

PubMed

Vasavada, Abhay R; Raj, Shetal M; Patel, Udayan; Vasavada, Vaishali; Vasavada, Viraj

2010-01-01

To compare intraoperative performance and postoperative outcome of three phacoemulsification technologies in patients undergoing microcoaxial phacoemulsification through 2.2-mm corneal incisions. The prospective, randomized, single-masked study included 360 eyes randomly assigned to torsional (Infiniti Vision System; Alcon Laboratories, Fort Worth, TX), microburst with longitudinal (Infiniti), or microburst with longitudinal (Legacy Everest, Alcon Laboratories) ultrasound. Assessments included surgical clock time, fluid volume, and intraoperative complications, central corneal thickness on day 1 and months 1 and 3 postoperatively, and endothelial cell density at 3 months postoperatively. Comparisons among groups were conducted. Torsional ultrasound required significantly less surgical clock time and fluid volume than the other groups. There were no intraoperative complications. Change in central corneal thickness and endothelial cell loss was significantly lower in the torsional ultrasound group at all postoperative visits (P < .001, Kruskal-Wallis test) compared to microburst longitudinal ultrasound modalities. Torsional ultrasound demonstrated quantitatively superior intraoperative performance and showed less increase in corneal thickness and less endothelial cell loss compared to microburst longitudinal ultrasound. Copyright 2010, SLACK Incorporated.

Sirolimus Associated with Tacrolimus at Low Doses in Elderly Kidney Transplant Patients: A Prospective Randomized Controlled Trial.

PubMed

Kojima, Cristiane Akemi; Nga, Hong Si; Takase, Henrique Mochida; Bravin, Ariane Moyses; Martinez Garcia, Márcia de Fátima Faraldo; Garcia, Paula Dalsoglio; Contti, Mariana Moraes; de Andrade, Luis Gustavo Modelli

2018-06-01

There is no consensus on the best immunosuppressive regimen for elderly renal transplant recipients. The objective of this study was to assess cytomegalovirus infection incidence and kidney transplant outcomes in elderly recipients treated with mammalian target of rapamycin inhibitors sirolimus/ tacrolimus at low doses compared with those receiving tacrolimus/mycophenolate sodium. In this single-center prospective randomized study (Trial Registration No. NCT02683291), kidney transplant recipients over 60 years of age were randomly allocated into 2 groups: tacrolimus-sirolimus (21 patients) and tacrolimus-mycophenolate (23 patients). Cytomegalovirus infection rate and patient survival, biopsy-proven acute rejection, and renal function at 12 months were assessed. Cytomegalovirus infection rate was higher in the mycophenolate group (60.9%) than in the sirolimus group (16.7%; P = .004). The rates of biopsy-proven acute rejection, patient survival, graft survival, and estimated glomerular filtration rate over 12 months did not significantly differ between groups. The incidence of cytomegalovirus infection was significantly lower in the sirolimus group. The use of tacrolimus combined with sirolimus in elderly kidney transplant recipients is safe.

Comparative study of the efficacy of transdermal buprenorphine patches and prolonged-release tramadol tablets for postoperative pain control after spinal fusion surgery: a prospective, randomized controlled non-inferiority trial.

PubMed

Kim, Ho-Joong; Ahn, Hyo Sae; Nam, Yunjin; Chang, Bong-Soon; Lee, Choon-Ki; Yeom, Jin S

2017-11-01

To compare the efficacy of a transdermal buprenorphine patch (5, 10, 15, and 20 μg/h) with that of oral tramadol (150, 200, 250, and 300 mg) for postoperative pain control after single level spinal fusion surgery. The present study (ClinicalTrials.gov, number NCT02416804) was a prospective, randomized controlled non-inferiority trial designed to determine the efficacy of buprenorphine TDS for alleviating postoperative pain following patient controlled analgesia (PCA) in persons underwent a single level posterior lumbar interbody fusion surgery through 1:1 allocation. The primary outcome was the Visual Analog Pain Scale (VAS) score for postoperative back pain at 7 days after surgery. The non-inferior margin of the VAS was set at δ = 1.5 points. The VAS score (primary outcome) for postoperative back pain at 7 days after surgery in the Buprenorphine group was not inferior compared to the Tramadol group. The overall changes in VAS scores for postoperative pain during follow-up assessments over a 2-week period did not differ between both groups. However, the VAS scores for postoperative pain significantly improved with time after surgery in both groups. The patterns of changes in the VAS scores for postoperative pain during the follow-up period were not significantly different between the both groups. The efficacy of buprenorphine TDS was not inferior to that of oral tramadol medication for alleviating postoperative pain in the subacute period from 72 h after surgery, following PCA administration. In addition, adverse events were similar between both groups.

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

2017-11-01

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.

Carotenoids and risk of fracture: a meta-analysis of observational studies

PubMed Central

Song, Xiaochao; Zhang, Xi; Li, Xinli

2017-01-01

To quantify the association between dietary and circulating carotenoids and fracture risk, a meta-analysis was conducted by searching MEDLINE and EMBASE databases for eligible articles published before May 2016. Five prospective and 2 case-control studies with 140,265 participants and 4,324 cases were identified in our meta-analysis. Among which 5 studies assessed the association between dietary carotenoids levels and hip fracture risk, 2 studies focused on the association between circulating carotenoids levels and any fracture risk. A random-effects model was employed to summarize the risk estimations and their 95% confidence intervals (CIs). Hip fracture risk among participants with high dietary total carotenoids intake was 28% lower than that in participants with low dietary total carotenoids (OR: 0.72; 95% CI: 0.51, 1.01). A similar risk of hip fracture was found for β-carotene based on 5 studies, the summarized OR for high vs. low dietary β-carotene was 0.72 (95% CI: 0.54, 0.95). However, a significant between-study heterogeneity was found (total carotene: I2 = 59.4%, P = 0.06; β-carotene: I2 = 74.4%, P = 0.04). Other individual carotenoids did not show significant associations with hip fracture risk. Circulating carotene levels had no significant association with any fracture risk, the pooled OR (95% CI) was 0.83 (0.59, 1.17). Based on the evidence from observational studies, our meta-analysis supported the hypothesis that higher dietary total carotenoids or β-carotene intake might be potentially associated with a low risk of hip fracture, however, future well-designed prospective cohort studies and randomized controlled trials are warranted to specify the associations between carotenoids and fracture. PMID:27911854

Carotenoids and risk of fracture: a meta-analysis of observational studies.

PubMed

Xu, Jiuhong; Song, Chunli; Song, Xiaochao; Zhang, Xi; Li, Xinli

2017-01-10

To quantify the association between dietary and circulating carotenoids and fracture risk, a meta-analysis was conducted by searching MEDLINE and EMBASE databases for eligible articles published before May 2016. Five prospective and 2 case-control studies with 140,265 participants and 4,324 cases were identified in our meta-analysis. Among which 5 studies assessed the association between dietary carotenoids levels and hip fracture risk, 2 studies focused on the association between circulating carotenoids levels and any fracture risk. A random-effects model was employed to summarize the risk estimations and their 95% confidence intervals (CIs). Hip fracture risk among participants with high dietary total carotenoids intake was 28% lower than that in participants with low dietary total carotenoids (OR: 0.72; 95% CI: 0.51, 1.01). A similar risk of hip fracture was found for β-carotene based on 5 studies, the summarized OR for high vs. low dietary β-carotene was 0.72 (95% CI: 0.54, 0.95). However, a significant between-study heterogeneity was found (total carotene: I2 = 59.4%, P = 0.06; β-carotene: I2 = 74.4%, P = 0.04). Other individual carotenoids did not show significant associations with hip fracture risk. Circulating carotene levels had no significant association with any fracture risk, the pooled OR (95% CI) was 0.83 (0.59, 1.17). Based on the evidence from observational studies, our meta-analysis supported the hypothesis that higher dietary total carotenoids or β-carotene intake might be potentially associated with a low risk of hip fracture, however, future well-designed prospective cohort studies and randomized controlled trials are warranted to specify the associations between carotenoids and fracture.

Cost-Effectiveness of Wisconsin TEAM Model for Improving Adherence and Hypertension Control in Black Patients

PubMed Central

Shireman, Theresa I.; Svarstad, Bonnie L.

2016-01-01

Objective To assess the cost-effectiveness of the 6-month Team Education and Adherence Monitoring (TEAM) intervention for black patients with hypertension in community pharmacies using prospectively collected cost data. Design Cost-effectiveness analysis of a cluster-randomized trial. Setting 28 chain pharmacies in five Wisconsin cities from December 2006 to February 2009. Participants 576 black patients with uncontrolled hypertension Intervention Pharmacists and pharmacy technicians using novel tools for improving adherence and feedback to patients and physicians as compared to information only control group. Main outcome measure(s) Incremental cost analysis of variable costs from the pharmacy perspective captured prospectively at the participant level. Outcomes (effect measures) were 6-month refill adherence, changes in SBP and DBP, and proportion of patients achieving BP control. Results Mean cost of intervention personnel time and tools was $104.8± 45.2. Incremental variable costs per mmHg decrease in SBP and DBP were $22.2 ± 16.3 and $66.0 ± 228.4, respectively. The cost of helping one more person achieve the BP goal (< 140/90) was $665.2 ± 265.2; the cost of helping one more person achieve good refill adherence was $463.3 ± 110.7. Prescription drug costs were higher for the TEAM group ($392.8, SD = 396.3 versus $307.0, SD = 295.2, p = 0.02). The start-up cost for pharmacy furniture, equipment, and privacy screen was $168 per pharmacy. Conclusions Our randomized, practice based intervention demonstrated that community pharmacists can implement a cost-effective intervention to improve hypertension control in blacks. This approach imposes a nominal expense at the pharmacy level, can be integrated into the ongoing pharmacist-patient relationship, and can enhance clinical and behavioral outcomes. PMID:27184784

Safety and feasibility of pulmonary artery pressure-guided heart failure therapy: rationale and design of the prospective CardioMEMS Monitoring Study for Heart Failure (MEMS-HF).

PubMed

Angermann, Christiane E; Assmus, Birgit; Anker, Stefan D; Brachmann, Johannes; Ertl, Georg; Köhler, Friedrich; Rosenkranz, Stephan; Tschöpe, Carsten; Adamson, Philip B; Böhm, Michael

2018-05-19

Wireless monitoring of pulmonary artery (PA) pressures with the CardioMEMS HF™ system is indicated in patients with New York Heart Association (NYHA) class III heart failure (HF). Randomized and observational trials have shown a reduction in HF-related hospitalizations and improved quality of life in patients using this device in the United States. MEMS-HF is a prospective, non-randomized, open-label, multicenter study to characterize safety and feasibility of using remote PA pressure monitoring in a real-world setting in Germany, The Netherlands and Ireland. After informed consent, adult patients with NYHA class III HF and a recent HF-related hospitalization are evaluated for suitability for permanent implantation of a CardioMEMS™ sensor. Participation in MEMS-HF is open to qualifying subjects regardless of left ventricular ejection fraction (LVEF). Patients with reduced ejection fraction must be on stable guideline-directed pharmacotherapy as tolerated. The study will enroll 230 patients in approximately 35 centers. Expected duration is 36 months (24-month enrolment plus ≥ 12-month follow-up). Primary endpoints are freedom from device/system-related complications and freedom from pressure sensor failure at 12-month post-implant. Secondary endpoints include the annualized rate of HF-related hospitalization at 12 months versus the rate over the 12 months preceding implant, and health-related quality of life. Endpoints will be evaluated using data obtained after each subject's 12-month visit. The MEMS-HF study will provide robust evidence on the clinical safety and feasibility of implementing haemodynamic monitoring as a novel disease management tool in routine out-patient care in selected European healthcare systems. ClinicalTrials.gov; NCT02693691.

Patient Acceptability of the Yorkshire Dialysis Decision Aid (YoDDA) Booklet: A Prospective Non-Randomized Comparison Study Across 6 Predialysis Services.

PubMed

Winterbottom, Anna E; Gavaruzzi, Teresa; Mooney, Andrew; Wilkie, Martin; Davies, Simon J; Crane, Dennis; Tupling, Ken; Baxter, Paul D; Meads, David M; Mathers, Nigel; Bekker, Hilary L

2016-01-01

♦ Patients are satisfied with their kidney care but want more support in making dialysis choices. Predialysis leaflets vary across services, with few being sufficient to enable patients' informed decision making. We describe the acceptability of a patient decision aid and feasibility of evaluating its effectiveness within usual predialysis practice. ♦ Prospective non-randomized comparison design, Usual Care or Usual Care Plus Yorkshire Dialysis Decision Aid Booklet (+YoDDA), in 6 referral centers (Yorkshire-Humber, UK) for patients with sustained deterioration of kidney function. Consenting (C) patients completed questionnaires after predialysis consultation (T1), and 6 weeks later (T2). Measures assessed YoDDA's utility to support patients' decisions and integration within usual care. ♦ Usual Care (n = 105) and +YoDDA (n = 84) participant characteristics were similar: male (62%), white (94%), age (mean = 62.6; standard deviation [SD] 14.4), kidney disease severity (glomerular filtration rate [eGFR] mean = 14.7; SD 3.7); decisional conflict was < 25; choice-preference for home versus hospital dialysis approximately 50:50. Patients valued receiving YoDDA, reading it on their own (96%), and sharing it with family (72%). The +YoDDA participants had higher scores for understanding kidney disease, reasoning about options, feeling in control, sharing their decision with family. Study engagement varied by center (estimated range 14 - 49%; mean 45%); participants varied in completion of decision quality measures. ♦ Receiving YoDDA as part of predialysis education was valued and useful to patients with worsening kidney disease. Integrating YoDDA actively within predialysis programs will meet clinical guidelines and patient need to support dialysis decision making in the context of patients' lifestyle. Copyright © 2016 International Society for Peritoneal Dialysis.

Critical review of immediate implant loading.

PubMed

Gapski, Ricardo; Wang, Hom-Lay; Mascarenhas, Paulo; Lang, Niklaus P

2003-10-01

Implant dentistry has become successful with the discovery of the biological properties of titanium. In the original protocol, studies have advocated a 2-stage surgical protocol for load-free and submerged healing to ensure predictable osseointegration. However, the discomfort, inconvenience, and anxiety associated with waiting period remains a challenge to both patients and clinicians. Hence, loading implant right after placement was attempted and has gained popularity among clinicians. Issues/questions related to this approach remain unanswered. Therefore, it is the purpose of this review article to (1). review and analyze critically the current available literature in the field of immediate implant loading and (2). discuss, based on scientific evidence, factors that may influence this treatment modality. Literature published over the past 20 years was selected and reviewed. Findings from these studies were discussed and summarized in the tables. The advantages and disadvantages associated with immediate implant loading were analyzed. Factors that may influence the success of immediate implant loading, including patient selection, type of bone quality, required implant length, micro- and macrostructure of the implant, surgical skill, need for achieving primary stability/control of occlusal force, and prosthesis guidelines, were thoroughly reviewed and discussed. Various studies have demonstrated the feasibility and predictability of this technique. However, most of these articles are based on retrospective data or uncontrolled cases. Randomized, prospective, parallel-armed longitudinal human trials are primarily based on short-term results and long-term follow-ups are still scarce in this field. Nonetheless, from available literature, it may be concluded that anatomic locations, implant designs, and restricted prosthetic guidelines are key to ensure successful outcomes. Future studies, preferably randomized, prospective longitudinal studies, are certainly needed before this approach can be widely used.

Benchmarking Is Associated With Improved Quality of Care in Type 2 Diabetes

PubMed Central

Hermans, Michel P.; Elisaf, Moses; Michel, Georges; Muls, Erik; Nobels, Frank; Vandenberghe, Hans; Brotons, Carlos

2013-01-01

OBJECTIVE To assess prospectively the effect of benchmarking on quality of primary care for patients with type 2 diabetes by using three major modifiable cardiovascular risk factors as critical quality indicators. RESEARCH DESIGN AND METHODS Primary care physicians treating patients with type 2 diabetes in six European countries were randomized to give standard care (control group) or standard care with feedback benchmarked against other centers in each country (benchmarking group). In both groups, laboratory tests were performed every 4 months. The primary end point was the percentage of patients achieving preset targets of the critical quality indicators HbA1c, LDL cholesterol, and systolic blood pressure (SBP) after 12 months of follow-up. RESULTS Of 4,027 patients enrolled, 3,996 patients were evaluable and 3,487 completed 12 months of follow-up. Primary end point of HbA1c target was achieved in the benchmarking group by 58.9 vs. 62.1% in the control group (P = 0.398) after 12 months; 40.0 vs. 30.1% patients met the SBP target (P < 0.001); 54.3 vs. 49.7% met the LDL cholesterol target (P = 0.006). Percentages of patients meeting all three targets increased during the study in both groups, with a statistically significant increase observed in the benchmarking group. The percentage of patients achieving all three targets at month 12 was significantly larger in the benchmarking group than in the control group (12.5 vs. 8.1%; P < 0.001). CONCLUSIONS In this prospective, randomized, controlled study, benchmarking was shown to be an effective tool for increasing achievement of critical quality indicators and potentially reducing patient cardiovascular residual risk profile. PMID:23846810

Reconciling divergent results of the latest parenteral nutrition studies in the ICU.

PubMed

Singer, Pierre; Pichard, Claude

2013-03-01

Recent studies on the optimal modalities to feed patients during the ICU stay show divergent results. The level and the timing of energy provision is a critical issue, associated with the clinical outcome. These results questioned the clinical relevance of the recent guidelines issued by American, Canadian and European academic societies. Four recent prospective randomized studies enrolled critically ill patients who received various nutritional regimens and tested the effect of nutritional support on outcome. The Tight Calorie balance Control Study (TICACOS) targeted on calorie administration according to measured energy expenditure and found increased ICU morbidity but improved hospital mortality. The large EpaNIC study compared 'early' with 'late' (parenteral nutrition) nutrition, mostly in patients after cardiac surgery, and found an increased morbidity associated with early parenteral nutrition. The supplemental parenteral nutrition (SPN) study randomized the patients after 3 days and targeted the calories administered by parenteral nutrition as a complement to unsuccessful enteral nutrition using indirect calorimetry. The SPN resulted in less nosocomial infections and shorter duration of mechanical ventilation. Finally, a recent Australian study enrolled patients unable to be early fed enterally to receive, or not, parenteral nutrition targeted at 1500 kcal. No complications were noted in the parenteral nutrition group. Lessons from all these studies are summarized and should help in designing better studies and guidelines. The critical analysis of recent prospective studies comparing various levels of calorie administration, enteral versus parenteral nutrition and enteral versus SPN confirms the recommendations to avoid underfeeding and overfeeding. Parenteral nutrition, required if enteral feeding is failing, and if adjusted up to a measured optimal level, may improve outcome. More studies on the optimal level of energy and protein administration to optimize the clinical outcome are required to fine tune current guidelines.

Breast Pocket Irrigation with Antibiotic Solution at Implant Insertion: A Systematic Review and Meta-Analysis.

PubMed

Lynch, Jessica M; Sebai, Mohamad E; Rodriguez-Unda, Nelson A; Seal, Stella; Rosson, Gedge D; Manahan, Michele A

2018-06-08

Antibiotic irrigation is routinely used during implant insertion in augmentation mammoplasty procedures. However, the evidence for whether this reduces the incidence of infection or capsular contracture is unclear. Five databases were used to search for all randomized control trials, retrospective cohort and prospective cohort studies containing original data related to the primary outcomes being investigated in this study. The primary outcomes were the effects of antibiotic breast pocket irrigation on clinical infection and capsular contracture. The literature search was designed to combine three concepts: implant or tissue expander-based breast surgery, antibiotic irrigation and clinical infection or capsular contracture. Studies found were screened using specific eligibility criteria. Risk ratios (RR) and 95% confidence interval (CI) were calculated using pooled acquired data from all included studies. The search identified 1256 citations. Three independent screeners identified seven studies that met the inclusion criteria with a pooled population of 4725. This included one prospective and six retrospective studies. A meta-analysis of pooled study data showed significant reductions in clinical infection (RR 0.52, 95% CI 0.33-0.81) and capsular contracture (RR 0.36, 95% CI 0.16-0.83) as a result of antibiotic irrigation. The meta-analyses support the use of antibiotic irrigation of the breast pocket. However, the results of this study are limited by the large proportion of retrospective studies, the small number of studies included, the lack of randomized controlled trials and the heterogeneity of the antibiotic and control regimes used. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Journal of Special Operations Medicine. Volume 4, Edition 1, Winter 2004

DTIC Science & Technology

2004-01-01

an ophthalmologist. He has been instrumental in PRK initiatives, has been a very productive mem- ber of the BISC, knows the risks of our missions...results to SOF mission commanders in a format suit- able for training at the unit level. 1999-3 PROSPECTIVE EVALUATION OF WAVE- FRONT-GUIDED PRK (Year...1 of 3) Conduct a prospective, randomized clinical trial to compare PRK for the treatment of naturally occurring myopia and astigmatism using

Video on Diet Before Outpatient Colonoscopy Does Not Improve Quality of Bowel Preparation: A Prospective, Randomized, Controlled Trial.

PubMed

Rice, Sean C; Higginbotham, Tina; Dean, Melanie J; Slaughter, James C; Yachimski, Patrick S; Obstein, Keith L

2016-11-01

Successful outpatient colonoscopy (CLS) depends on many factors including the quality of a patient's bowel preparation. Although education on consumption of the pre-CLS purgative can improve bowel preparation quality, no study has evaluated dietary education alone. We have created an educational video on pre-CLS dietary instructions to determine whether dietary education would improve outpatient bowel preparation quality. A prospective randomized, blinded, controlled study of patients undergoing outpatient CLS was performed. All patients received a 4 l polyethylene glycol-based split-dose bowel preparation and standard institutional pre-procedure instructions. Patients were then randomly assigned to an intervention arm or to a no intervention arm. A 4-min educational video detailing clear liquid diet restriction was made available to patients in the intervention arm, whereas those randomized to no intervention did not have access to the video. Patients randomized to the video were provided with the YouTube video link 48-72 h before CLS. An attending endoscopist blinded to randomization performed the CLS. Bowel preparation quality was scored using the Boston Bowel Preparation Scale (BBPS). Adequate preparation was defined as a BBPS total score of ≥6 with all segment scores ≥2. Wilcoxon rank-sum and Pearson's χ 2 -tests were performed to assess differences between groups. Ninety-two patients were randomized (video: n=42; control: n=50) with 47 total video views being tallied. There were no demographic differences between groups. There was no statistically significant difference in adequate preparation between groups (video=74%; control=68%; P=0.54). The availability of a supplementary patient educational video on clear liquid diet alone was insufficient to improve bowel preparation quality when compared with standard pre-procedure instruction at our institution.

The UAE healthy future study: a pilot for a prospective cohort study of 20,000 United Arab Emirates nationals.

PubMed

Abdulle, Abdishakur; Alnaeemi, Abdullah; Aljunaibi, Abdullah; Al Ali, Abdulrahman; Al Saedi, Khaled; Al Zaabi, Eiman; Oumeziane, Naima; Al Bastaki, Marina; Al-Houqani, Mohammed; Al Maskari, Fatma; Al Dhaheri, Ayesha; Shah, Syed M; Loney, Tom; El-Sadig, Mohamed; Oulhaj, Abderrahim; Wareth, Leila Abdel; Al Mahmeed, Wael; Alsafar, Habiba; Hirsch, Benjamin; Al Anouti, Fatme; Yaaqoub, Jamila; Inman, Claire K; Al Hamiz, Aisha; Al Hosani, Ayesha; Haji, Muna; Alsharid, Teeb; Al Zaabi, Thekra; Al Maisary, Fatima; Galani, Divya; Sprosen, Tim; El Shahawy, Omar; Ahn, Jiyoung; Kirchhoff, Tomas; Ramasamy, Ravichandran; Schmidt, Ann Marie; Hayes, Richard; Sherman, Scott; Ali, Raghib

2018-01-05

The United Arab Emirates (UAE) is faced with a rapidly increasing burden of non-communicable diseases including obesity, diabetes, and cardiovascular disease. The UAE Healthy Future study is a prospective cohort designed to identify associations between risk factors and these diseases amongst Emiratis. The study will enroll 20,000 UAE nationals aged ≥18 years. Environmental and genetic risk factors will be characterized and participants will be followed for future disease events. As this was the first time a prospective cohort study was being planned in the UAE, a pilot study was conducted in 2015 with the primary aim of establishing the feasibility of conducting the study. Other objectives were to evaluate the implementation of the main study protocols, and to build adequate capacity to conduct advanced clinical laboratory analyses. Seven hundred sixty nine UAE nationals aged ≥18 years were invited to participate voluntarily in the pilot study. Participants signed an informed consent, completed a detailed questionnaire, provided random blood, urine, and mouthwash samples and were assessed for a series of clinical measures. All specimens were transported to the New York University Abu Dhabi laboratories where samples were processed and analyzed for routine chemistry and hematology. Plasma, serum, and a small whole blood sample for DNA extraction were aliquoted and stored at -80 °C for future analyses. Overall, 517 Emirati men and women agreed to participate (68% response rate). Of the total participants, 495 (95.0%), 430 (82.2%), and 492 (94.4%), completed the questionnaire, physical measurements, and provided biological samples, respectively. The pilot study demonstrated the feasibility of recruitment and completion of the study protocols for the first large-scale cohort study designed to identify emerging risk factors for the major non-communicable diseases in the region.

Pain Management after Laparoscopic Cholecystectomy-A Randomized Prospective Trial of Low Pressure and Standard Pressure Pneumoperitoneum

PubMed Central

Singla, Sanjeev; Mittal, Geeta; Raghav; Mittal, Rajinder K

2014-01-01

Background: Abdominal pain and shoulder tip pain after laparoscopic cholecystectomy are distressing for the patient. Various causes of this pain are peritoneal stretching and diaphragmatic irritation by high intra-abdominal pressure caused by pneumoperitoneum . We designed a study to compare the post operative pain after laparoscopic cholecystectomy at low pressure (7-8 mm of Hg) and standard pressure technique (12-14 mm of Hg). Aim : To compare the effect of low pressure and standard pressure pneumoperitoneum in post laparoscopic cholecystectomy pain . Further to study the safety of low pressure pneumoperitoneum in laparoscopic cholecystectomy. Settings and Design: A prospective randomised double blind study. Materials and Methods: A prospective randomised double blind study was done in 100 ASA grade I & II patients. They were divided into two groups -50 each. Group A patients underwent laparoscopic cholecystectomy with low pressure pneumoperitoneum (7-8 mm Hg) while group B underwent laparoscopic cholecystectomy with standard pressure pneumoperitoneum (12-13 mm Hg). Both the groups were compared for pain intensity, analgesic requirement and complications. Statistical Analysis: Demographic data and intraoperative complications were analysed using chi-square test. Frequency of pain, intensity of pain and analgesics consumption was compared by applying ANOVA test. Results: Post-operative pain score was significantly less in low pressure group as compared to standard pressure group. Number of patients requiring rescue analgesic doses was more in standard pressure group . This was statistically significant. Also total analgesic consumption was more in standard pressure group. There was no difference in intraoperative complications. Conclusion: This study demonstrates the use of simple expedient of reducing the pressure of pneumoperitoneum to 8 mm results in reduction in both intensity and frequency of post-operative pain and hence early recovery and better outcome.This study also shows that low pressure technique is safe with comparable rate of intraoperative complications. PMID:24701492

Does partial coating with titanium improve the radiographic fusion rate of empty PEEK cages in cervical spine surgery? A comparative analysis of clinical data.

PubMed

Kotsias, Andreas; Mularski, Sven; Kühn, Björn; Hanna, Michael; Suess, Olaf

2017-01-01

Anterior cervical diskectomy and fusion (ACDF) is a well-established surgical treatment. Several types of intervertebral spacers can be used, but there is increasing evidence that PEEK cages yield insufficient fusion and thus less clinical improvement. The study aim was to assess the outcomes of single-level ACDF with an empty PEEK cage partially coated with titanium. This prospective multicenter single-arm clinical study collected follow-up data at 6, 12, and 18 months. A post hoc comparison was made to closely matched patients from another similar trial treated with identically designed, empty, uncoated PEEK cages. There were 49 of 50 patients (98%) who met the MCID of 3+ points of improvement on VAS pain or had an 18-month VAS ≤ 1. Yet even by 18 months post-op, only 40 of 50 (80%) PEEK + Ti patients achieved complete bony fusion. The PEEK + Ti group ( n  = 49) seemed to have somewhat better fusion scores and significantly better pain relief at 6 M than the matched controls ( n  = 49), but these differences did not persist at 12 M or 18 M. Patients (with either implant) who achieved complete bony fusion had significantly better improvement of pain at 6 M and disability at 6 M and 12 M than patients that remained unfused. ACDF is effective treatment for cervical myelopathy and radiculopathy. Although this and other studies show that titanium fuses better, partial coating of a PEEK cage does not improve the fusion rate sufficiently or confer other lasting clinical benefit. PEEK cages fully coated with titanium should be tested in prospective randomized comparative trials. Prospective, multicenter, single-arm clinical observational study without an individual Trial registration number. Study design and post hoc data analysis according to the "PIERCE-PEEK study", ISRCTN42774128, retrospectively registered 14 April 2009.

Acute myocardial infarction and cardiogenic shock: prognostic impact of cytokines: INF-γ, TNF-α, MIP-1β, G-CSF, and MCP-1β.

PubMed

Prondzinsky, R; Unverzagt, S; Lemm, H; Wegener, N; Heinroth, K; Buerke, U; Fiedler, M; Thiery, J; Haerting, J; Werdan, K; Buerke, M

2012-09-01

The IABP SHOCK trial was designed as a morbidity-based randomized controlled trial to determine the effect of intraaortic balloon pulsation (IABP) in patients with infarct-related cardiogenic shock (CS). The primary endpoint was the change in the APACHE II score over a 4-day period. The prospective hypothesis was that adding IABP therapy to "standard care" would reduce CS-triggered multiorgan dysfunction syndrome (MODS). The primary endpoint showed no difference between conventionally managed cardiogenic shock patients and those with additional IABP support. In an inflammatory marker substudy, we analyzed the prognostic value of the cytokines interferon-γ (INF-γ), tumor necrosis factor-α (TNF-α), macrophage inflammatory protein-1β (MIP-1β), granulocyte-colony stimulating factor (G-CSF), and monocyte chemoattractant protein-1β (MCP-1β). We also investigated the influence of IABP support, age, and gender on cytokine levels. The inflammatory marker substudy of the prospective, randomized, controlled, open label IABP SHOCK Trial (ClinicalTrials.gov ID NCT00469248). A prospective, randomized, single-center study in a 12-bed intensive care unit at a university hospital was performed. A total of 40 consecutive patients were enrolled. The observational period was 96 h. The investigated cytokines showed a significant contribution in the prediction of mortality. Initial (on admission) and maximal cytokine levels during the observational period showed a similar predictive power. Patients with elevated levels of pro- and antiinflammatory cytokines had a higher risk of dying. The maximal level measured over the observation period in the hospital was also suited to identify the survivors. Close correlations between maximal cytokine levels resulted in the choice of only one independent marker (MIP-1β) into the multivariate model (OR 1.024, 95% CI 1.005-1.043). Initial cytokine levels were also suitable to predict the survivors; the risk of death significantly increases with increasing IFN-γ level (OR 1.119, 95% CI 1.005-1.246). Cytokine levels were not affected by the presence of IABP support. Age (< 75 or > 75 years) and gender did not have a clinically relevant effect on INF-γ, TNF-α, MIP-1β, G-CSF, and MCP-1 in CS patients. The inflammatory response in patients with myocardial infarction complicated by CS, as reflected by the inflammatory markers INF-γ, TNF-α, MIP-1β, G-CSF, and MCP-1β, have been shown to be of prognostic value in estimating clinical outcome.

WWC Quick Review of the Article "Outcomes of a Prospective Trial of Student-Athlete Drug Testing: The Student Athlete Testing Using Random Notification ('SATURN') Study"

ERIC Educational Resources Information Center

What Works Clearinghouse, 2008

2008-01-01

This study examines whether the Student Athlete Testing Using Random Notification ("SATURN") program affects illicit drug and alcohol use among student athletes. The study experienced high rates of sample attrition. Seven of the 18 study schools (39%) left the study and were not included in the analysis. Some students at the remaining…

Differences in highly cross-linked polyethylene wear between zirconia and cobalt-chromium femoral heads in Japanese patients: a prospective, randomized study.

PubMed

Kawate, Kenji; Ohmura, Tetsuji; Kawahara, Ikuo; Tamai, Katsuya; Ueha, Tomoyuki; Takemura, Kazuo

2009-12-01

The purpose of this study was to compare highly cross-linked polyethylene wear between the zirconia head and the cobalt-chromium head in Japanese patients. A prospective, randomized study was performed to evaluate the outcomes in 32 hips that had zirconia heads and in 30 hips that had cobalt-chromium heads. The mean follow-up periods of both groups were same (5 years). There were no significant differences between the zirconia head and the cobalt-chromium head in the mean polyethylene linear wear per year and the mean volumetric polyethylene wear per year in the steady phase. This study indicates that zirconia head offers no benefits over metal head in terms of wear reduction at 5 years in Japanese patients who have lightweight and thin polyethylene liners.

Is Electrocautery of Patella Useful in Patella Non-Resurfacing Total Knee Arthroplasty?: A Prospective Randomized Controlled Study.

PubMed

Kwon, Sae Kwang; Nguku, Levis; Han, Chang Dong; Koh, Yong-Gon; Kim, Dong-Wook; Park, Kwan Kyu

2015-12-01

There is controversy over the need for electrocauterization of the patella in non-resurfacing total knee arthroplasty (TKA). We investigated whether this procedure is beneficial through a prospective randomized controlled trial. Fifty patients who underwent electrocautery were compared with 50 patients who did not undergo this procedure. We determined cartilage status, preoperative and postoperative American Knee Society (AKS) score, the Western Ontario and McMaster Universities score (WOMAC) and the Patellofemoral (PF) scores for a minimum of 5 years. The two groups did not differ significantly in demographics, intraoperative cartilage status, or preoperative or postoperative outcomes. No complications were detected in either group. We found no benefits of electrocautery of the patella in patellar non-resurfacing TKA up to 5 years. Copyright © 2015 Elsevier Inc. All rights reserved.

Carvedilol prospective randomized cumulative survival (COPERNICUS) trial: carvedilol in severe heart failure.

PubMed

Fowler, Michael B

2004-05-06

The impact of carvedilol on the survival of patients with severe heart failure was examined in the Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial. The trial recruited 2,289 patients with symptoms at rest or on minimal exertion despite therapy with angiotensin-converting enzyme inhibitors and a left ventricular ejection fraction of < or = 0.25. After an average follow-up period of 10.4 months, mortality was reduced by 34% in the carvedilol group. Carvedilol also reduced the number of days spent in the hospital for any cause by 27% and the number of days spent in the hospital for heart failure by 40%. Patients in the carvedilol group felt better and were less likely to have a serious adverse event. The benefits of carvedilol appeared early and were detected during the up-titration period.

Magnesium Sulfate Reduced Opioid Consumption in Obese Patients Undergoing Sleeve Gastrectomy: a Prospective, Randomized Clinical Trial.

PubMed

Kizilcik, Nurcan; Koner, Ozge

2018-05-12

The purpose of the study was to investigate the effect of magnesium sulfate on pain management for pain after sleeve gastrectomy operation. A prospective, randomized, placebo-controlled clinical study. University hospital. Eighty patients undergoing sleeve gastrectomy. Visual analog scale for the evaluation of pain, sedation score, mean arterial pressure, heart rate, and total analgesic consumption was recorded. Serum magnesium levels were determined before the operation, at the end of the operation, and at 24 h. There were no significant differences between the groups with respect to demographics, and sedation scores. Cumulative morphine consumption and pain scores were found to be higher in the control group than the magnesium group. Perioperative use of magnesium sulfate reduced postoperative pain and opioid consumption in obese patients undergoing sleeve gastrectomy operations.

Efficacy of fluoride varnish for preventing white spot lesions and gingivitis during orthodontic treatment with fixed appliances-a prospective randomized controlled trial.

PubMed

Kirschneck, Christian; Christl, Jan-Joachim; Reicheneder, Claudia; Proff, Peter

2016-12-01

The development of white spot lesions around orthodontic brackets and gingivitis is a common problem during orthodontic treatment with fixed appliances. This prospective randomized double-blind controlled clinical trial investigated the preventive efficacy of a one-time application of two commonly used fluoride varnishes in patients with low to moderate caries risk. Ninety adolescent orthodontic patients with a low to moderate caries risk were prospectively randomized to three groups of 30 patients each: (1) standardized dental hygiene with fluoride toothpaste and one-time application of placebo varnish (control) or (2) of elmex® fluid or (3) of Fluor Protector S on all dental surfaces at the start of fixed therapy. The extent of enamel demineralization and gingivitis was determined with the ICDAS and the gingivitis index (GI) at baseline and after 4, 12, and 20 weeks. Each treatment group showed a significant increase of the ICDAS index, but not of the GI over the course of time with no significant intergroup differences detectable. A one-time application of fluoride varnish at the start of orthodontic treatment did not provide any additional preventive advantage over sufficient dental hygiene with fluoride toothpaste with regard to formation of white spots and gingivitis in patients with a low to moderate caries risk. In dental practice, patients often receive an application of fluoride varnish at the start of orthodontic treatment with fixed appliances. However, the efficacy of this procedure is still unclear.

Endoscopic versus traditional saphenous vein harvesting: a prospective, randomized trial.

PubMed

Allen, K B; Griffith, G L; Heimansohn, D A; Robison, R J; Matheny, R G; Schier, J J; Fitzgerald, E B; Shaar, C J

1998-07-01

Saphenous vein harvested with a traditional longitudinal technique often results in leg wound complications. An alternative endoscopic harvest technique may decrease these complications. One hundred twelve patients scheduled for elective coronary artery bypass grafting were prospectively randomized to have vein harvested using either an endoscopic (group A, n = 54) or traditional technique (group B, n = 58). Groups A and B, respectively, were similar with regard to length of vein harvested (41 +/- 8 cm versus 40 +/- 14 cm), bypasses done (4.1 +/- 1.1 versus 4.2 +/- 1.4), age, preoperative risk stratification, and risks for wound complication (diabetes, sex, obesity, preoperative anemia, hypoalbuminemia, and peripheral vascular disease). Leg wound complications were significantly (p < or = 0.02) reduced in group A (4% [2 of 51] versus 19% [11 of 58]). Univariate analysis identified traditional incision (p < or = 0.02) and diabetes (p < or = 0.05) as wound complication risk factors. Multiple logistic regression analysis identified only the traditional harvest technique as a risk factor for leg wound complications with no significant interaction between harvest technique and any preoperative risk factor (p < or = 0.03). Harvest rate (0.9 +/- 0.4 cm/min versus 1.2 +/- 0.5 cm/min) was slower for group A (p < or = 0.02) and conversion from endoscopic to a traditional harvest occurred in 5.6% (3 of 54) of patients. In a prospective, randomized trial, saphenous vein harvested endoscopically was associated with fewer wound complications than the traditional longitudinal method.

Prospective randomized trial: outcomes of SF₆ versus C₃F₈ in macular hole surgery.

PubMed

Briand, Sophie; Chalifoux, Emmanuelle; Tourville, Eric; Bourgault, Serge; Caissie, Mathieu; Tardif, Yvon; Giasson, Marcelle; Boivin, Jocelyne; Blanchette, Caty; Cinq-Mars, Benoit

2015-04-01

To compare macular hole (MH) closure and visual acuity improvement after vitrectomy using SF6 versus C3F8 gas tamponade. The secondary purposes were to report the cumulative incidence of cataract development at 1 year after MH surgery and the proportion of complications. Prospective, randomized study. Thirty-one patients were prospectively randomized to the SF6 group and 28 patients to the C3F8 group. Preoperative data included MH minimum diameter, Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA), cataract staging, and intraocular pressure (IOP) measurement. Postoperative data included optical coherence tomography confirmation of the closure at 6 weeks and 1 year, and ETDRS BCVA and cataract development/extraction, both 1 year after the MH surgery. Primary MH closure was achieved in 93.3% in the SF6 group and 92.9% in the C3F8 group. Mean ETDRS BCVA improved by 17.7 letters in the SF6 and 16.9 letters in the C3F8 group. The difference in cumulative incidence of cataract development and extraction between both groups was not statistically significant. Regardless of the dye used, similar results were achieved. Finally, the proportion of adverse events was similar in both groups. MH surgery with SF6 gas achieves results similar to C3F8 in terms of visual acuity improvement, MH closure, cataract development/extraction, and adverse events. Copyright © 2015 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

Comparison of Tension-Band Wiring With the Cable Pin System in Patella Fractures: A Randomized Prospective Study.

PubMed

Tian, Qing-xian; Hai, Yong; Du, Xin-ru; Xu, Zi-yu; Lu, Tie; Shan, Lei; Liu, Yang; Zhou, Jun-lin

2015-12-01

To compare the outcome of tension-band wiring (TBW) with the cable pin system (CPS) for transverse fractures of the patella. Randomized prospective study. Academic Level I trauma center. From February 2008 to December 2011, 73 consecutive patients with transverse fractures of the patella were prospectively enrolled in this study. The patients were randomly divided into 2 groups: one group was treated using the CPS, and the other group was treated using the modified TBW. The clinical outcome assessment included analyses of the radiographic images, the modified Hospital for Special Surgery scoring system, and complications. The follow-up time ranged from 12 to 29 months. All fractures healed, with a union rate of 100%. The fracture healing time was significantly shorter in the CPS group (8.51 ± 2.59 weeks, n = 34) compared with the TBW group (11.79 ± 3.04 weeks, n = 39). Postoperative complications in the CPS and TBW groups were observed in 1 and 9 patients, respectively, a difference that was statistically significant. The mean Hospital for Special Surgery score for the CPS group (90.53 ± 5.19 points) was significantly higher than that for the TBW group (81.36 ± 12.71 points). The CPS is a viable option for transverse fractures of the patella and is associated with a shorter healing time, fewer complications, and better function than TBW. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Intrapartum amnioinfusion in women with oligohydramniosis. A prospective randomized trial.

PubMed

Persson-Kjerstadius, N; Forsgren, H; Westgren, M

1999-02-01

To evaluate the effects of amnioinfusion in oligohydramniosis. During a 20-month period, patients at term with oligohydramniosis (amniotic fluid index less than 5 cm) at Huddinge University and Norrköping Hospitals were recruited for a prospective randomized study to evaluate amnioinfusion. Informed consent was obtained from 112 patients who met the entry criteria. Sixty subjects were randomized to amnioinfusion and 52 to the control group. Outcome parameters included fetal heart rate abnormalities, mode of delivery, Apgar score, pH in umbilical artery blood and need for neonatal intensive care. The cesarean section rate was significantly reduced in the amnio-infusion group (29% versus 13%, p=0.043). No difference in time from randomization to delivery was detected between the two groups. The frequency of ominous fetal heart rate tracings with a cervical dilatation of 0-3 cm was the same in the two groups. The frequency of such heart rate patterns after amnioinfusion was significantly lower than in the control group. Neonatal outcome, pH in the umbilical artery blood and need for neonatal intensive care did not differ between the two groups. The present study confirms the findings of other authors that amnioinfusion effectively reduces the number of cesarean sections in cases of oligohydramniosis.

A meta-analysis of comparative outcomes following cervical arthroplasty or anterior cervical fusion: results from 4 prospective multicenter randomized clinical trials and up to 1226 patients.

PubMed

McAfee, Paul C; Reah, Chris; Gilder, Kye; Eisermann, Lukas; Cunningham, Bryan

2012-05-15

Meta-analysis of 4 prospective randomized controlled Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical trials. To maximize the information available from 4 IDE studies by analyzing the combined outcomes of cervical arthroplasty versus fusion at 24-month follow-up. To date, 4 randomized clinical trials have been completed in the United States under FDA IDE protocols to study cervical arthroplasty. Each trial reported arthroplasty to be at least as successful as fusion controls based on noninferiority trial designs. However, sample sizes in any given trial may not be sufficient to demonstrate superiority of treatment effect. Meta-analysis enables pooling of results from comparable trials, which may lead to more precise and statistically significant estimates of treatment effect. Four cervical arthroplasty randomized clinical trials with comparable enrollment criteria and outcome measures were conducted independently by 3 separate sponsors to study the following devices: Bryan, Prestige, ProDisc-C, and PCM cervical disc replacements. A total of 1608 patients were treated across 98 investigative sites. Data were available for 1352 treated patients, of which 1226 were evaluable at 24 months. Assessments included clinical success definitions based on neck disability index, maintenance or improvement of neurological status, subsequent surgery or intervention at the index level (survivorship), and a composite score comprising these as well as serious device-related adverse events. Trial endpoint comparisons were made at 24 months postoperatively. For each endpoint, a random-effects meta-analysis was performed to compare the success rates of cervical arthroplasty with anterior cervical discectomy and fusion (ACDF). Also, supportive frequentist and bayesian analyses were performed. The pooled primary overall success results indicated a statistically significant treatment effect favoring arthroplasty compared with ACDF. Overall success was achieved by 77.6% of the arthroplasty patients and by 70.8% of the ACDF patients (pooled odds ratio [OR]: 0.699, 95% confidence interval [CI]: 0.539-0.908, P = 0.007). The results of the individual subcomponent meta-analyses, all of which favored arthroplasty, were neck disability index success (OR: 0.786, 95% CI: 0.589-1.050, P = 0.103), neurological status (OR: 0.552, 95% CI: 0.364-0.835, P = 0.005), and survivorship (OR: 0.510, 95% CI: 0.275-0.946, P = 0.033). Only the survivorship endpoint suggested low heterogeneity. These findings suggest that cervical arthroplasty is superior to ACDF in overall success, neurological success, and survivorship outcomes at 24 months postoperatively.

Sheehan Suicidality Tracking Scale (Sheehan-STS)

PubMed Central

2009-01-01

Objective: Accurate and prospective assessments of treatment-emergent suicidal thoughts and behaviors are essential to both clinical care and randomized clinical trials. The Sheehan Suicidality Tracking Scale is a prospective, patient self-report or clinician-administered rating scale that tracks both treatment-emergent suicidal ideation and behaviors. The Sheehan Suicidality Tracking Scale was incorporated into a multicenter, randomized, double-blind, placebo-controlled, and active comparator study examining the efficacy of an experimental corticotropin-releasing factor antagonist (BMS-562086) for the treatment of generalized anxiety disorder. Method: The Sheehan Suicidality Tracking Scale was administered to subjects at baseline, Week 2, Week 4, and Week 8 or early termination. Subjects completed theSheehan Suicidality Tracking Scale by self report. The Sheehan Suicidality Tracking Scale was designated as an exploratory outcome measure in the study protocol, and post-hoc analyses were performed to examine the performance of the Sheehan Suicidality Tracking Scale. Results: A total of 82 subjects completed the Sheehan Suicidality Tracking Scale during the course of the study. Altogether, these subjects provided 297 completed Sheehan Suicidality Tracking Scale ratings across the study time points. Sixty-one subjects (n=25 placebo, n=24 BMS-562086, and n=12 escitalopram) had a baseline and at least one post-baseline Sheehan Suicidality Tracking Scale measurement. The mean change from baseline at Week 8 in the Sheehan Suicidality Tracking Scale total score was -0.10, -0.02, and -0.06 for escitalopram, placebo, and BMS-562086 groups, respectively. The sensitivity of the Sheehan Suicidality Tracking Scale and HAM-D Item #3 (suicide) for identifying subjects with suicidal thoughts or behaviors was 100 percent and 63 percent, respectively. Conclusions: The Sheehan Suicidality Tracking Scale may be a sensitive psychometric tool to prospectively assess for treatment-emergent suicidal thoughts and behaviors. Despite the small sample size and low occurrence of suicidal ideation during the course of this clinical trial, the self-reported Sheehan Suicidality Tracking Scale demonstrated increased sensitivity over the rater administered HAM-D Item #3 in identifying suicide related ideations and behaviors. Further research in larger study samples as well as in other psychiatric disorders are needed. PMID:19724740

A mindfulness-based stress prevention training for medical students (MediMind): study protocol for a randomized controlled trial.

PubMed

Kuhlmann, Sophie Merle; Bürger, Arne; Esser, Günter; Hammerle, Florian

2015-02-08

Medical training is very demanding and associated with a high prevalence of psychological distress. Compared to the general population, medical students are at a greater risk of developing a psychological disorder. Various attempts of stress management training in medical school have achieved positive results on minimizing psychological distress; however, there are often limitations. Therefore, the use of a rigorous scientific method is needed. The present study protocol describes a randomized controlled trial to examine the effectiveness of a specifically developed mindfulness-based stress prevention training for medical students that includes selected elements of cognitive behavioral strategies (MediMind). This study protocol presents a prospective randomized controlled trial, involving four assessment time points: baseline, post-intervention, one-year follow-up and five-year follow-up. The aims include evaluating the effect on stress, coping, psychological morbidity and personality traits with validated measures. Participants are allocated randomly to one of three conditions: MediMind, Autogenic Training or control group. Eligible participants are medical or dental students in the second or eighth semester of a German university. They form a population of approximately 420 students in each academic term. A final total sample size of 126 (at five-year follow-up) is targeted. The trainings (MediMind and Autogenic Training) comprise five weekly sessions lasting 90 minutes each. MediMind will be offered to participants of the control group once the five-year follow-up is completed. The allotment is randomized with a stratified allocation ratio by course of studies, semester, and gender. After descriptive statistics have been evaluated, inferential statistical analysis will be carried out with a repeated measures ANOVA-design with interactions between time and group. Effect sizes will be calculated using partial η-square values. Potential limitations of this study are voluntary participation and the risk of attrition, especially concerning participants that are allocated to the control group. Strengths are the study design, namely random allocation, follow-up assessment, the use of control groups and inclusion of participants at different stages of medical training with the possibility of differential analysis. This trial is recorded at German Clinical Trials Register under the number DRKS00005354 (08 November 2013).

Relapse of Graves' disease after successful outcome of antithyroid drug therapy: results of a prospective randomized study on the use of levothyroxine.

PubMed

Hoermann, Rudolf; Quadbeck, Beate; Roggenbuck, Ulla; Szabolcs, István; Pfeilschifter, Johannes; Meng, Wieland; Reschke, Kirsten; Hackenberg, Klaus; Dettmann, Juergen; Prehn, Brigitte; Hirche, Herbert; Mann, Klaus

2002-12-01

Antithyroid drugs are effective in restoring euthyroidism in Graves' disease, but many patients experience relapse after withdrawal. Prevention of recurrence would therefore be a desirable goal. In a prospective study, patients with successful outcome of 12 to 15 months antithyroid drug therapy were stratified for risk factors and randomly assigned to receive levothyroxine in a variable thyrotropin (TSH)-suppressive dose for 2 years or no treatment. The levothyroxine group was randomized to continue or discontinue levothyroxine after 1 year. End points included relapse of overt hyperthyroidism. Of 346 patients with Graves' disease enrolled 225 were euthyroid 4 weeks after antithyroid drug withdrawal and were randomly assigned to receive levothyroxine (114 patients) or no treatment (controls, 111 patients). Of those not randomized, 39 patients showed early relapse within 4 weeks, 61 endogenous TSH suppression, 7 TSH elevation, and 14 had to be excluded. Dropout rate during the study were 13.3%. Kaplan-Meier analyses showed relapse rates to be similar in the levothyroxine group (20% after 1 year, 32% after 2 years) and the randomized controls (18%, 24%), whereas relapses were significantly more frequent in the follow-up group of patients with endogenously suppressed TSH (33%, 49%). Levothyroxine therapy did not influence TSH-receptor antibody, nor did it reduce goiter size. The best prognostic marker available was basal TSH determined 4 weeks after withdrawal of antithyroid drugs (posttreatment TSH). The study demonstrates that levothyroxine does not prevent relapse of hyperthyroidism after successful restoration of euthyroid function by antithyroid drugs and characterizes posttreatment TSH as a main prognostic marker.

Prone position as prevention of lung injury in comatose patients: a prospective, randomized, controlled study.

PubMed

Beuret, Pascal; Carton, Marie-Jose; Nourdine, Karim; Kaaki, Mahmoud; Tramoni, Gerard; Ducreux, Jean-Claude

2002-05-01

Comatose patients frequently exhibit pulmonary function worsening, especially in cases of pulmonary infection. It appears to have a deleterious effect on neurologic outcome. We therefore conducted a randomized trial to determine whether daily prone positioning would prevent lung worsening in these patients. Prospective, randomized, controlled study. Sixteen-bed intensive care unit. Fifty-one patients who required invasive mechanical ventilation because of coma with Glascow coma scores of 9 or less. In the prone position (PP) group: prone positioning for 4 h once daily until the patients could get up to sit in an armchair; in the supine position (SP) group: supine positioning. The primary end point was the incidence of lung worsening defined by an increase in the Lung Injury Score of at least 1 point since the time of randomization. The secondary end point was the incidence of ventilator-associated pneumonia (VAP). A total of 25 patients were randomly assigned to the PP group and 26 patients to the SP group. The characteristics of the patients from the two groups were similar at randomization. The incidence of lung worsening was lower in the PP group (12%) than in the SP group (50%) ( p=0.003). The incidence of VAP was 20% in the PP group and 38.4% in the SP group ( p=0.14). There was no serious complication attributable to prone positioning, however, there was a significant increase of intracranial pressure in the PP. In a selected population of comatose ventilated patients, daily prone positioning reduced the incidence of lung worsening.

Spontaneous pushing to prevent postpartum urinary incontinence: a randomized, controlled trial

PubMed Central

Miller, Janis M.; Guo, Ying; Ashton-Miller, James A.; DeLancey, John O. L.; Sampselle, Carolyn M.

2014-01-01

Introduction and hypothesis The risk for urinary incontinence can be 2.6-fold greater in women after pregnancy and childbirth compared with their never-pregnant counterparts, with the incidence increasing with parity. We tested the hypothesis that the incidence of de novo postpartum urinary incontinence in primiparous women is reduced with the use of spontaneous pushing alone or in combination with perineal massage compared with women who experienced traditional directed pushing for second-stage management. Methods This was a prospective clinical trial enrolling and randomizing 249 women into a four-group design: (1) routine care with coached or directed pushing, (2) spontaneous self-directed pushing, (3) prenatal perineal massage initiated in the third trimester, and (4) the combination of spontaneous pushing plus perineal massage. Self-report of incontinence was assessed using analysis of variance (ANOVA) and covariance (ANCOVA) models in 145 remaining women at 12 months postpartum using the Leakage Index, which is sensitive to minor leakage. Results No statistical difference in the incidence of de novo postpartum incontinence was found based on method of pushing (spontaneous/directed) (P value=0.57) or in combination with prenatal perineal massage (P value=0.57). Fidelity to pushing treatment of type was assessed and between-groups crossover detected. Conclusions Spontaneous pushing did not reduce the incidence of postpartum incontinence experienced by women 1 year after their first birth due to high cross-over between randomization groups. PMID:22829349

Spontaneous pushing to prevent postpartum urinary incontinence: a randomized, controlled trial.

PubMed

Low, Lisa Kane; Miller, Janis M; Guo, Ying; Ashton-Miller, James A; DeLancey, John O L; Sampselle, Carolyn M

2013-03-01

The risk for urinary incontinence can be 2.6-fold greater in women after pregnancy and childbirth compared with their never-pregnant counterparts, with the incidence increasing with parity. We tested the hypothesis that the incidence of de novo postpartum urinary incontinence in primiparous women is reduced with the use of spontaneous pushing alone or in combination with perineal massage compared with women who experienced traditional directed pushing for second-stage management. This was a prospective clinical trial enrolling and randomizing 249 women into a four-group design: (1) routine care with coached or directed pushing, (2) spontaneous self-directed pushing, (3) prenatal perineal massage initiated in the third trimester, and (4) the combination of spontaneous pushing plus perineal massage. Self-report of incontinence was assessed using analysis of variance (ANOVA) and covariance (ANCOVA) models in 145 remaining women at 12 months postpartum using the Leakage Index, which is sensitive to minor leakage. No statistical difference in the incidence of de novo postpartum incontinence was found based on method of pushing (spontaneous/directed) (P value = 0.57) or in combination with prenatal perineal massage (P value = 0.57). Fidelity to pushing treatment of type was assessed and between-groups crossover detected. Spontaneous pushing did not reduce the incidence of postpartum incontinence experienced by women 1 year after their first birth due to high cross-over between randomization groups.

eEduHeart I: A Multicenter, Randomized, Controlled Trial Investigating the Effectiveness of a Cardiac Web-Based eLearning Platform - Rationale and Study Design.

PubMed

Frederix, Ines; Vandenberk, Thijs; Janssen, Leen; Geurden, Anne; Vandervoort, Pieter; Dendale, Paul

Cardiac telerehabilitation includes, in its most comprehensive format, telemonitoring, telecoaching, social interaction, and eLearning. The specific role of eLearning, however, was seldom assessed. The aim of eEduHeart I is to investigate the medium-term effectiveness of the addition of a cardiac web-based eLearing platform to conventional cardiac care. In this prospective, multicenter randomized, controlled trial, 1,000 patients with coronary artery disease will be randomized 1:1 to an intervention group (receiving 1-month unrestricted access to the cardiac eLearning platform in addition to conventional cardiac care) or to conventional cardiac care alone. The primary endpoint is health-related quality of life, assessed by the HeartQoL questionnaire at the 1- and 3-month follow-ups. Secondary endpoints include pathology-specific knowledge and self-reported eLearning platform user experience. Data on the eLearning platform usage will be gathered through web logging during the study period. eEduHeart I will be one of the first studies to report on the added value of eLearning. If the intervention is proven effective, current cardiac telerehabilitation programs can be augmented by including eLearning, too. The platform can then be used as a model for other chronic diseases in which patient education plays a key role. © 2016 S. Karger AG, Basel.

Pre-discharge stress echocardiography and exercise ECG for risk stratification after uncomplicated acute myocardial infarction: results of the COSTAMI-II (cost of strategies after myocardial infarction) trial

PubMed Central

Desideri, A; Fioretti, P M; Cortigiani, L; Trocino, G; Astarita, C; Gregori, D; Bax, J; Velasco, J; Celegon, L; Bigi, R; Pirelli, S; Picano, E

2005-01-01

Objective: To compare in a prospective, randomised, multicentre trial the relative merits of pre-discharge exercise ECG and early pharmacological stress echocardiography concerning risk stratification and costs of treating patients with uncomplicated acute myocardial infarction. Design: 262 patients from six participating centres with a recent uncomplicated myocardial infarction were randomly assigned to early (day 3–5) pharmacological stress echocardiography (n  =  132) or conventional pre-discharge (day 7–9) maximum symptom limited exercise ECG (n  =  130). Results: No complication occurred during either stress echocardiography or exercise ECG. At one year follow up there were 26 events (1 death, 5 non-fatal reinfarctions, 20 patients with unstable angina requiring hospitalisation) in patients randomly assigned to early stress echocardiography and 18 events (2 reinfarctions, 16 unstable angina requiring hospitalisation) in the group randomly assigned to exercise ECG (not significant). The negative predictive value was 92% for stress echocardiography and 88% for exercise ECG (not significant). Total costs of the two strategies were similar (not significant). Conclusion: Early pharmacological stress echocardiography and conventional pre-discharge symptom limited exercise ECG have similar clinical outcome and costs after uncomplicated infarction. Early pharmacological stress echocardiography should be considered a valid alternative even for patients with interpretable baseline ECG who can exercise. PMID:15657220

A Feasibility Study Comparing Platelet-Rich Plasma Injection With Saline for the Treatment of Plantar Fasciitis Using a Prospective, Randomized Trial Design.

PubMed

Johnson-Lynn, Sarah; Cooney, Alan; Ferguson, Diarmaid; Bunn, Deborah; Gray, William; Coorsh, Jonathan; Kakwani, Rajesh; Townshend, David

2018-05-01

Platelet-rich plasma (PRP) has been advocated for treatment of plantar fasciitis but there are few good-quality clinical trials to support its use. We conducted a feasibility study of PRP versus saline for treatment of plantar fasciitis. Patients with 6 months or more of magnetic resonance imaging-proven plantar fasciitis, who had failed conservative treatment were invited to participate in the study. Patients were block randomized to either PRP or an equivalent volume of saline. The techniques used for injection and rehabilitation were standardized for both groups. The patient and assessor were blinded. Visual analogue scale (VAS) for pain and painDETECT score were recorded preoperatively and at 6 months follow-up. From 35 patients approached, 28 (19 female, mean age 50 years) were recruited, with 14 randomized to each arm. At 6 months, 8 patients (28.6%) were lost to follow-up. There was a significant change in VAS score from baseline to follow-up in both intervention (mean change 37.2, P = .008) and control (mean change 42.2, P = .003) groups. There was no correlation between preoperative painDETECT score and change in VAS. Recruitment and loss to follow-up rates were relatively high. Both treatments resulted in a similar, significant, improvement in symptoms. Level II.

Xerostomia health-related quality of life: NRG oncology RTOG 0537.

PubMed

Wyatt, Gwen; Pugh, Stephanie L; Wong, Raimond K W; Sagar, Stephen; Singh, Anurag K; Koyfman, Shlomo A; Nguyen-Tân, Phuc F; Yom, Sue S; Cardinale, Francis S; Sultanem, Khalil; Hodson, Ian; Krempl, Greg A; Lukaszczyk, Barbara; Yeh, Alexander M; Berk, Lawrence

2016-09-01

The purpose of this secondary analysis was to determine change in overall health-related quality of life (HRQOL) based on patient data obtained from NRG Oncology RTOG 0537 as measured by the RTOG-modified University of Washington Head and Neck Symptom Score (RM-UWHNSS). A multi-site prospective randomized clinical trial design stratified 137 patients with post-radiation therapy xerostomia according to prior pilocarpine (PC) treatment and time after radiation therapy and/or chemotherapy and randomized patients into two groups. Patients were assigned to acupuncture or PC. Twenty-four sessions of acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) were administered over 12 weeks, or oral PC (5 mg) three times daily over the same 12 weeks. The RM-UWHNSS was administered at baseline and at 4, 6, 9, and 15 months after the date of randomization. There were no between-arm differences in change scores on the RM-UWHNSS in the individual items, total score, or factor scores. For statistical modeling, race and time were significant for all outcomes (total and factor scores), while treatment arm was not significant. The ALTENS arm showed greater yet nonsignificant improvement in outcomes compared to the PC arm. Although no significant treatment differences were seen in this trial, patients receiving ALTENS consistently had lower scores, indicating better function, as compared to those receiving PC. Radiation-induced xerostomia improved over time for all patients.

Cost-effectiveness of Internet-based cognitive behavior therapy vs. cognitive behavioral group therapy for social anxiety disorder: results from a randomized controlled trial.

PubMed

Hedman, Erik; Andersson, Erik; Ljótsson, Brjánn; Andersson, Gerhard; Rück, Christian; Lindefors, Nils

2011-11-01

Social anxiety disorder (SAD) is highly prevalent and associated with a substantial societal economic burden, primarily due to high costs of productivity loss. Cognitive behavior group therapy (CBGT) is an effective treatment for SAD and the most established in clinical practice. Internet-based cognitive behavior therapy (ICBT) has demonstrated efficacy in several trials in recent years. No study has however investigated the cost-effectiveness of ICBT compared to CBGT from a societal perspective, i.e. an analysis where both direct and indirect costs are included. The aim of the present study was to investigate the cost-effectiveness of ICBT compared to CBGT from a societal perspective using a prospective design. We conducted a randomized controlled trial where participants with SAD were randomized to ICBT (n=64) or CBGT (n=62). Economic data were assessed at pre-treatment, immediately following treatment and six months after treatment. Results showed that the gross total costs were significantly reduced at six-month follow-up, compared to pre-treatment in both treatment conditions. As both treatments were equivalent in reducing social anxiety and gross total costs, ICBT was more cost-effective due to lower intervention costs. We conclude that ICBT can be more cost-effective than CBGT in the treatment of SAD and that both treatments reduce societal costs for SAD. Copyright © 2011 Elsevier Ltd. All rights reserved.

Fibrin tissue adhesive reduces postoperative blood loss in total knee arthroplasty.

PubMed

Sabatini, Luigi; Trecci, Andrea; Imarisio, Daniele; Uslenghi, Marco Davide; Bianco, Giuseppe; Scagnelli, Roberto

2012-09-01

Blood transfusion is often required in total knee replacement; various methods of blood preservation have been studied. The best solution is to reduce the loss of blood during and after surgery. We designed this study to evaluate the hemostatic efficacy and safety of fibrin tissue adhesive (Quixil) in patients receiving total knee arthroplasty [low contact stress (LCS, DePuy, Warsaw, IN, US) cementless total knee replacement (TKR)] with a prospective, randomized, standard treatment controlled study. Thirty-five patients were randomized to receive treatment with fibrin tissue adhesive (treatment group), and 35 were randomized to be managed with postoperative blood recovery and reinfusion (control group). Blood loss in suction drain, decrease in hemoglobin values, and transfusions were recorded. A significant reduction in apparent total blood loss was detected in the treatment group compared with the control group. There was also a lower decrease in hemoglobin level, although this difference was not significant. When fibrin tissue adhesive was administered, the need for transfusions was lower. No major adverse events were recorded in our series. Fibrin tissue adhesive reduced blood loss in TKR and seemed to significantly reduce the need for blood transfusion. Fibrin tissue adhesive can be an appropriate solution to enhance hemostasis and vessel sealing at the operative site in TKR, in order to reduce blood loss after surgery and the risk of complications.

COMplex Fracture Orthopedic Rehabilitation (COMFORT) - Real-time visual biofeedback on weight bearing versus standard training methods in the treatment of proximal femur fractures in the elderly: study protocol for a multicenter randomized controlled trial.

PubMed

Raaben, Marco; Redzwan, Syaiful; Augustine, Robin; Blokhuis, Taco Johan

2018-04-12

Proximal femur fractures are a common injury after low energy trauma in the elderly. Most rehabilitation programs are based on restoring mobility and early resumption of weight-bearing. However, therapy compliance is low in patients following lower extremity fractures. Moreover, little is known about the relevance of gait parameters and how to steer the rehabilitation after proximal femur fractures in the elderly. Therefore, the aim of this prospective, randomized controlled trial is to gain insight in gait parameters and evaluate if real-time visual biofeedback can improve therapy compliance after proximal femur fractures in the elderly. This is a two-arm, parallel-design, prospective, randomized controlled trial. Inclusion criteria are age ≥ 60 years, a proximal femur fracture following low energy trauma, and unrestricted-weight bearing. Exclusion criteria are cognitive impairment and limited mobility before trauma. Participants are randomized into either the control group, which receives care as usual, or the intervention group, which receives real-time visual biofeedback about weight-bearing during gait in addition to care as usual. Spatiotemporal gait parameters will be measured in 94 participants per group during a 30-m walk with an ambulatory biofeedback system (SensiStep). The progress of rehabilitation will be evaluated by the primary outcome parameters maximum peak load and step duration in relation to the discharge date. Secondary outcome parameters include other spatiotemporal gait parameters in relation to discharge date. Furthermore, the gait parameters will be related to three validated clinical tests: Elderly Mobility Scale; Functional Ambulation Categories; and Visual Analogue Scale. The primary hypothesis is that participants in the intervention group will show improved and faster rehabilitation compared to the control group. The first aim of this multicenter trial is to investigate the normal gait patterns after proximal femur fractures in the elderly. The use of biofeedback systems during rehabilitation after proximal femur fractures in the elderly is promising; therefore, the second aim is to investigate the effect of real-time visual biofeedback on gait after proximal femur fractures in the elderly. This could lead to improved outcome. In addition, analysis of the population may indicate characteristics of subgroups that benefit from feedback, making a differentiated approach in rehabilitation strategy possible. TrialRegister.nl, NTR6794 . Registered on 31 October 2017.

[Eyelid hygiene for contact lens wearers with blepharitis. Comparative investigation of treatment with baby shampoo versus phospholipid solution].

PubMed

Khaireddin, R; Hueber, A

2013-02-01

Blepharitis due to Meibom gland dysfunction (MGD) is presumed to be one of the main reasons for dry eye symptoms which occur in up to 50% of contact lens users. Thus, MGD presumably plays an important role in dry eye in contact lens wearers. In the present prospective, randomized and double blind trial the efficacy of two established treatment options for MGD and blepharitis was evaluated in symptomatic contact lens wearers. In this prospective, randomized 2-centre trial 53 symptomatic contact lens wearers suffering from blepharitis were included. Patients were randomly selected for two treatment groups: group A performed lid margin hygiene using the commonly recommended mild baby shampoo (Bübchen Kinder Shampoo-extra augenmild, Bübchen Werk Ewald Hermes Pharmazeutische Fabrik GmbH, Soest, Germany) and group B performed lid margin hygiene using a phospholipid-liposome solution specially designed for lid hygiene (Blepha Cura, Optima, Moosburg/Wang, Germany), each for 4 weeks. Before as well as 4 weeks after initiation of this study the following tests were performed: standardized subjective assessment using the ocular surface disease index, non-invasive break-up time (NIBUT) and objective evaluation of lid-parallel conjunctival folds (LIPCOF) and further lid margin criteria by double blinded evaluation of slit lamp photographs. Of the 53 symptomatic contact lens wearers suffering from blepharitis 21 (39,6%) were randomly selected for treatment group A and 32 (60.4%) for group B. In both treatment groups there was objective and subjective improvement of symptoms of dry eye in contact lens wearers. Interestingly, there was a significantly greater improvement, subjective as well as objective, in treatment group B which used the phospholipidliposome solution for lid margin hygiene compared to group A using baby shampoo. Although both therapies improved symptoms of dry eye due to blepharitis in symptomatic contact lens wearers, patients using phospholipid-liposomal solution for lid margin hygiene demonstrated a significantly greater clinical benefit from the therapy. Thus, clinical practice recommending just baby shampoo for lid margin hygiene should be re-considered, as phospholipid-liposomal solution for lid margin hygiene appears to yield greater and faster clinical benefits for symptomatic contact lens wearers suffering from dry eye symptoms.

Static balance and function in children with cerebral palsy submitted to neuromuscular block and neuromuscular electrical stimulation: Study protocol for prospective, randomized, controlled trial

PubMed Central

2012-01-01

Background The use of botulinum toxin A (BT-A) for the treatment of lower limb spasticity is common in children with cerebral palsy (CP). Following the administration of BT-A, physical therapy plays a fundamental role in potentiating the functionality of the child. The balance deficit found in children with CP is mainly caused by muscle imbalance (spastic agonist and weak antagonist). Neuromuscular electrical stimulation (NMES) is a promising therapeutic modality for muscle strengthening in this population. The aim of the present study is to describe a protocol for a study aimed at analyzing the effects of NMES on dorsiflexors combined with physical therapy on static and functional balance in children with CP submitted to BT- A. Methods/Design Protocol for a prospective, randomized, controlled trial with a blinded evaluator. Eligible participants will be children with cerebral palsy (Levels I, II and III of the Gross Motor Function Classification System) between five and 12 years of age, with independent gait with or without a gait-assistance device. All participants will receive BT-A in the lower limbs (triceps surae). The children will then be randomly allocated for either treatment with motor physical therapy combined with NMES on the tibialis anterior or motor physical therapy alone. The participants will be evaluated on three occasions: 1) one week prior to the administration of BT-A; 2) one week after the administration of BT-A; and 3) four months after the administration of BT-A (end of intervention). Spasticity will be assessed by the Modified Ashworth Scale and Modified Tardieu Scale. Static balance will be assessed using the Medicapteurs Fusyo pressure platform and functional balance will be assessed using the Berg Balance Scale. Discussion The aim of this protocol study is to describe the methodology of a randomized, controlled, clinical trial comparing the effect of motor physical therapy combined with NMES on the tibialis anterior muscle or motor physical therapy alone on static and functional balance in children with CP submitted to BT-A in the lower limbs. This study describes the background, hypotheses, methodology of the procedures and measurement of the results. Trial registration RBR5qzs8h PMID:22591446

Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial

PubMed Central

2011-01-01

Background The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%), non-union (5-21%) and early osteo-arthritis (up to 32%) which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences. Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. Methods/Design This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning). Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory. Study parameters are clinical consolidation, radiological consolidation evaluated by CT-scanning, functional status of the wrist, including assessment by means of the patient rated wrist evaluation (PRWE) questionnaire and quality of life using SF-36 health survey questionnaire. Primary endpoint is number of scaphoid unions at six weeks, secondary endpoints are time interval to clinical and radiological consolidation, number of non-unions, functional status at 52 weeks and non-adherence to the treatment protocol. Trial registration Netherlands Trial Register (NTR): NTR2064 PMID:21548951

DEcompressive Surgery for the Treatment of malignant INfarction of the middle cerebral arterY - Registry (DESTINY-R): design and protocols

PubMed Central

2012-01-01

Background Randomized controlled trials (RCT) on the treatment of severe space-occupying infarction of the middle cerebral artery (malignant MCA infarction) showed that early decompressive hemicraniectomy (DHC) is life saving and improves outcome without promoting most severe disablity in patients aged 18–60 years. It is, however, unknown whether the results obtained in the randomized trials are reproducible in a broader population in and apart from an academical setting and whether hemicraniectomy has been implemented in clinical practice as recommended by national and international guidelines. In addition, they were not powered to answer further relevant questions, e.g. concerning the selection of patients eligible for and the timing of hemicraniectomy. Other important issues such as the acceptance of disability following hemicraniectomy, the existence of specific prognostic factors, the value of conservative therapeutic measures, and the overall complication rate related to hemicraniectomy have not been sufficiently studied yet. Methods/Design DESTINY-R is a prospective, multicenter, open, controlled registry including a 12 months follow-up. The only inclusion criteria is unilateral ischemic MCA stroke affecting more than 50% of the MCA-territory. The primary study hypothesis is to confirm the results of the RCT (76% mRS ≤ 4 after 12 months) in the subgroup of patients additionally fulfilling the inclusion cirteria of the RCT in daily routine. Assuming a calculated proportion of 0.76 for successes and a sample size of 300 for this subgroup, the width of the 95% CI, calculated using Wilson's method, will be 0.096 with the lower bound 0.709 and the upper bound 0.805. Discussion The results of this study will provide information about the effectiveness of DHC in malignant MCA infarction in a broad population and a real-life situation in addition to and beyond RCT. Further prospectively obtained data will give crucial information on open questions and will be helpful in the plannig of upcomming treatment studies. Trial registration (ICTRP and DRKS): DRKS00000624 PMID:23031451

Feasibility study of the RenalGuard™ balanced hydration system: a novel strategy for the prevention of contrast-induced nephropathy in high risk patients.

PubMed

Dorval, Jean-Francois; Dixon, Simon R; Zelman, Richard B; Davidson, Charles J; Rudko, Robert; Resnic, Frederic S

2013-06-20

Contrast-induced nephropathy (CIN) is a frequent complication following angiographic procedures with significant impact on healthcare costs, and long-term outcomes. Multiple reno-protective strategies have been studied but few have shown benefit in prospective randomized studies beyond limiting the exposure to iodinated contrast and adequate intravenous. We studied the performance and safety of a novel system designed to achieve precise real-time high volume fluid balance using a closed loop hydration monitoring and infusion system. This prospective, multi-center, FDA approved phase II feasibility study was designed to evaluate the safety and the performance of the RenalGuard matched hydration system. Between October 2006 and November 2007, twenty-three subjects at high risk for CIN (with an estimated glomerular filtration rate (eGFR)<50ml/min/1.73m(2)) undergoing diagnostic or therapeutic catheterization were treated with the system. The primary endpoint of the study was defined as the ability of the system to effectively dynamically match fluid administration to urine output. The 23 subjects at high risk for CIN enrolled had a mean±SD eGFR of 39±9.3. Patients achieved an hourly urine flow rate of 620±400ml/h. The system had a mean effectiveness rate of 99.9% over the duration of therapy with an average saline volume infused of 3825ml closely matched, minute to minute, to urine output of 3579ml. There were no major device-related complications from the experimental therapy, though one patient developed hypokalemia requiring replacement. Two subjects (9.5%) developed CIN as defined by >0.5mg/dl or >25% rise in serum creatinine at 48-60h post contrast administration when compared with the baseline. The study confirmed that the RenalGuard(TM) system is safe and dynamically balances volume hydration with urine production. Further randomized studies are needed to confirm the efficacy of the system in reducing the incidence of CIN. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Investing in Prospective Cohorts for Etiologic Study of Occupational Exposures

PubMed Central

Blair, A.; Hines, C.J.; Thomas, K.W.; Alavanja, M.C.R.; Beane Freeman, L.E.; Hoppin, J.A.; Kamel, F.; Lynch, C.F.; Lubin, J.H.; Silverman, D.T.; Whelan, E.; Zahm, S. H.; Sandler, D. P.

2015-01-01

Prospective cohorts have played a major role in understanding the contribution of diet, physical activity, medical conditions, and genes to the development of many diseases, but have not been widely used for occupational exposures. Studies in agriculture are an exception. We draw upon our experience using this design to study agricultural workers to identify conditions that might foster use of prospective cohorts to study other occupational settings. Prospective cohort studies are perceived by many as the strongest epidemiologic design. It allows updating of information on exposure and other factors, collection of biologic samples before disease diagnosis for biomarker studies, assessment of effect modification by genes, lifestyle, and other occupational exposures, and evaluation of a wide range of health outcomes. Increased use of prospective cohorts would be beneficial in identifying hazardous exposures in the workplace. Occupational epidemiologists should seek opportunities to initiate prospective cohorts to investigate high priority, occupational exposures. PMID:25603935

A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial): study rationale and design

PubMed Central

2012-01-01

Background Severe hypoglycaemia still represents a significant problem in insulin-treated diabetes. Most patients do not experience severe hypoglycaemia often. However, 20% of patients with type 1 diabetes experience recurrent severe hypoglycaemia corresponding to at least two episodes per year. The effect of insulin analogues on glycaemic control has been documented in large trials, while their effect on the frequency of severe hypoglycaemia is less clear, especially in patients with recurrent severe hypoglycaemia. The HypoAna Trial is designed to investigate whether short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing the occurrence of severe hypoglycaemic episodes in patients with recurrent hypoglycaemia. This paper reports the study design of the HypoAna Trial. Methods/design The study is a Danish two-year investigator-initiated, prospective, randomised, open, blinded endpoint (PROBE), multicentre, cross-over trial investigating the effect of insulin analogues versus human insulin on the frequency of severe hypoglycaemia in subjects with type 1 diabetes. Patients are randomised to treatment with basal-bolus therapy with insulin detemir / insulin aspart or human NPH insulin / human regular insulin in random order. The major inclusion criterion is history of two or more episodes of severe hypoglycaemia in the preceding year. Discussion In contrast to almost all other studies in this field the HypoAna Trial includes only patients with major problems with hypoglycaemia. The HypoAna Trial will elucidate whether basal-bolus regimen with short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing occurrence of severe hypoglycaemic episodes in hypoglycaemia prone patients with type 1 diabetes. http://www.clinicaltrials.gov: NCT00346996. PMID:22727048

Coordinating resources for prospective medication risk management of older home care clients in primary care: procedure development and RCT study design for demonstrating its effectiveness.

PubMed

Toivo, Terhi; Dimitrow, Maarit; Puustinen, Juha; Savela, Eeva; Pelkonen, Katariina; Kiuru, Valtteri; Suominen, Tuula; Kinnunen, Sirkka; Uunimäki, Mira; Kivelä, Sirkka-Liisa; Leikola, Saija; Airaksinen, Marja

2018-03-16

The magnitude of safety risks related to medications of the older adults has been evidenced by numerous studies, but less is known of how to manage and prevent these risks in different health care settings. The aim of this study was to coordinate resources for prospective medication risk management of home care clients ≥ 65 years in primary care and to develop a study design for demonstrating effectiveness of the procedure. Health care units involved in the study are from primary care in Lohja, Southern Finland: home care (191 consented clients), the public healthcare center, and a private community pharmacy. System based risk management theory and action research method was applied to construct the collaborative procedure utilizing each profession's existing resources in medication risk management of older home care clients. An inventory of clinical measures in usual clinical practice and systematic review of rigorous study designs was utilized in effectiveness study design. The new coordinated medication management model (CoMM) has the following 5 stages: 1) practical nurses are trained to identify clinically significant drug-related problems (DRPs) during home visits and report those to the clinical pharmacist. Clinical pharmacist prepares the cases for 2) an interprofessional triage meeting (50-70 cases/meeting of 2 h) where decisions are made on further action, e.g., more detailed medication reviews, 3) community pharmacists conduct necessary medication reviews and each patients' physician makes final decisions on medication changes needed. The final stages concern 4) implementation and 5) follow-up of medication changes. Randomized controlled trial (RCT) was developed to demonstrate the effectiveness of the procedure. The developed procedure is feasible for screening and reviewing medications of a high number of older home care clients to identify clients with severe DRPs and provide interventions to solve them utilizing existing primary care resources. The study is registered in the Clinical Trials.gov ( NCT02545257 ). Registration date September 9 2015.

New Estimates of Design Parameters for Clustered Randomization Studies: Findings from North Carolina and Florida. Working Paper 43

ERIC Educational Resources Information Center

Xu, Zeyu; Nichols, Austin

2010-01-01

The gold standard in making causal inference on program effects is a randomized trial. Most randomization designs in education randomize classrooms or schools rather than individual students. Such "clustered randomization" designs have one principal drawback: They tend to have limited statistical power or precision. This study aims to…

47 CFR 1.1602 - Designation for random selection.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 1 2010-10-01 2010-10-01 false Designation for random selection. 1.1602 Section 1.1602 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND PROCEDURE Random Selection Procedures for Mass Media Services General Procedures § 1.1602 Designation for random selection...

47 CFR 1.1602 - Designation for random selection.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 47 Telecommunication 1 2011-10-01 2011-10-01 false Designation for random selection. 1.1602 Section 1.1602 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND PROCEDURE Random Selection Procedures for Mass Media Services General Procedures § 1.1602 Designation for random selection...

Stressful life events and cancer risk

PubMed Central

Bergelt, C; Prescott, E; Grønbæk, M; Koch, U; Johansen, C

2006-01-01

In a prospective cohort study in Denmark of 8736 randomly selected people, no evidence was found among 1011 subjects who developed cancer that self-reported stressful major life events had increased their risk for cancer. PMID:17106440

Prospective Elemantary Science Teachers' Epistemological Beliefs

ERIC Educational Resources Information Center

Macaroglu Akgul, Esra; Oztuna Kaplan, Aysun

2009-01-01

This research study examined "prospective elementary science teachers' epistemological beliefs". Forty-nine prospective elementary science teachers participated into research. The research was designed in both quantitative and qualitative manner, within the context of "Special Methods in Science Teaching I" course.…