Intravenous iron vs blood for acute post-partum anaemia (IIBAPPA): a prospective randomised trial.

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Chua, Seng; Gupta, Sarika; Curnow, Jennifer; Gidaszewski, Beata; Khajehei, Marjan; Diplock, Hayley

2017-12-19

Acute post-partum anaemia can be associated with significant morbidity including a predisposition for postnatal depression. Lack of clear practice guidelines means a number of women are treated with multiple blood transfusions. Intravenous iron has the potential to limit the need for multiple blood transfusions but its role in the post-partum setting is unclear. IIBAPPA is a multi-centre randomised non-inferiority trial. Women with a primary post-partum haemorrhage (PPH) >1000 mL and resultant haemoglobin (Hb) 5.5-8.0 g/dL after resuscitation with ongoing symptomatic anaemia who are otherwise stable (no active bleeding) are eligible to participate. Patients with sepsis or conditions necessitating rapid Hb restoration are excluded. Eligible participants are randomised to receive a blood transfusion or a single dose of intravenous iron polymaltose calculated using the Ganzoni formula. Primary outcome measures include Hb, Ferritin and C-Reactive Protein levels on Day 7. Secondary outcomes evaluate (i) Hb, Ferritin and CRP levels on Day 14, 28, (ii) anaemia symptoms on Day 0, 7, 14 and 28 using structured health related quality of life questionnaires, (iii) treatment safety by assessing adverse reactions and infection endpoints and (iv) the quantitative impact of anaemia on breast feeding quality using a hospital designed questionnaire. If equivalence in Hb and ferritin levels, symptom scores and safety endpoints is demonstrated, intravenous iron may become the preferred treatment for women with acute post-partum anaemia to minimise transfusion reactions and costs. Australian and New Zealand Clinical Trials Registry: ACTRN12615001370594 on 16th December, 2015 (prospective approval).

Serious adverse events after HPV vaccination: a critical review of randomized trials and post-marketing case series.

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Martínez-Lavín, Manuel; Amezcua-Guerra, Luis

2017-10-01

This article critically reviews HPV vaccine serious adverse events described in pre-licensure randomized trials and in post-marketing case series. HPV vaccine randomized trials were identified in PubMed. Safety data were extracted. Post-marketing case series describing HPV immunization adverse events were reviewed. Most HPV vaccine randomized trials did not use inert placebo in the control group. Two of the largest randomized trials found significantly more severe adverse events in the tested HPV vaccine arm of the study. Compared to 2871 women receiving aluminum placebo, the group of 2881 women injected with the bivalent HPV vaccine had more deaths on follow-up (14 vs. 3, p = 0.012). Compared to 7078 girls injected with the 4-valent HPV vaccine, 7071 girls receiving the 9-valent dose had more serious systemic adverse events (3.3 vs. 2.6%, p = 0.01). For the 9-valent dose, our calculated number needed to seriously harm is 140 (95% CI, 79–653) [DOSAGE ERROR CORRECTED] . The number needed to vaccinate is 1757 (95% CI, 131 to infinity). Practically, none of the serious adverse events occurring in any arm of both studies were judged to be vaccine-related. Pre-clinical trials, post-marketing case series, and the global drug adverse reaction database (VigiBase) describe similar post-HPV immunization symptom clusters. Two of the largest randomized HPV vaccine trials unveiled more severe adverse events in the tested HPV vaccine arm of the study. Nine-valent HPV vaccine has a worrisome number needed to vaccinate/number needed to harm quotient. Pre-clinical trials and post-marketing case series describe similar post-HPV immunization symptoms.

Six-month exercise training program to treat post-thrombotic syndrome: a randomized controlled two-centre trial

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Kahn, Susan R.; Shrier, Ian; Shapiro, Stan; Houweling, Adrielle H.; Hirsch, Andrew M.; Reid, Robert D.; Kearon, Clive; Rabhi, Khalil; Rodger, Marc A.; Kovacs, Michael J.; Anderson, David R.; Wells, Philip S.

2011-01-01

Background Exercise training may have the potential to improve post-thrombotic syndrome, a frequent, chronic complication of deep venous thrombosis. We conducted a randomized controlled two-centre pilot trial to assess the feasibility of a multicentre-based evaluation of a six-month exercise training program to treat post-thrombotic syndrome and to obtain preliminary data on the effectiveness of such a program. Methods Patients were randomized to receive exercise training (a six-month trainer-supervised program) or control treatment (an education session with monthly phone follow-ups). Levels of eligibility, consent, adherence and retention were used as indicators of study feasibility. Primary outcomes were change from baseline to six months in venous disease-specific quality of life (as measured using the Venous Insufficiency Epidemiological and Economic Study Quality of Life [VEINES-QOL] questionnaire) and severity of post-thrombotic syndrome (as measured by scores on the Villalta scale) in the exercise training group versus the control group, assessed by t tests. Secondary outcomes were change in generic quality of life (as measured using the Short-Form Health Survey-36 [SF-36] questionnaire), category of severity of post-thrombotic syndrome, leg strength, leg flexibility and time on treadmill. Results Of 95 patients with post-thrombotic syndrome, 69 were eligible, 43 consented and were randomized, and 39 completed the study. Exercise training was associated with improvement in VEINES-QOL scores (exercise training mean change 6.0, standard deviation [SD] 5.1 v. control mean change 1.4, SD 7.2; difference 4.6, 95% CI 0.54 to 8.7; p = 0.027) and improvement in scores on the Villalta scale (exercise training mean change −3.6, SD 3.7 v. control mean change −1.6, SD 4.3; difference −2.0, 95% CI −4.6 to 0.6; p = 0.14). Most secondary outcomes also showed greater improvement in the exercise training group. Interpretation Exercise training may improve post

How long-lasting is the post-conflict slowing after incongruent trials? Evidence from the Stroop, Simon, and flanker tasks.

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Rey-Mermet, Alodie; Meier, Beat

2017-10-01

The purpose of the present study was to determine how long-lasting the post-conflict slowing following incongruent stimuli is. In previous research, incongruent stimuli have been used to induce a conflict because they have relevant features for two different response alternatives. So far, the post-conflict slowing following incongruent stimuli has mainly been assessed up to one trial. In the first two experiments, we assessed the persistence of the post-conflict slowing across several trials. To this end, we presented a few incongruent stimuli among non-conflict stimuli. The results showed a consistent slowing for the first few trials immediately following the incongruent trials. In addition, a sporadic slowing was still found on later trials. In two subsequent experiments, we investigated to what extent the infrequency of incongruent trials - rather than their conflict - induced this slowing. To determine this, we used the same design as in the first two experiments, but we presented non-conflict stimuli as infrequent stimuli. The results showed a slowing on one subsequent trial, ruling out the possibility that the post-conflict slowing following incongruent trials was only caused by infrequency. Together, the findings of the present study indicate that the conflict induced by incongruent trials can have a longer lasting impact on subsequent trials than previously thought.

Nausea and Vomiting following Balanced Xenon Anesthesia Compared to Sevoflurane: A Post-Hoc Explorative Analysis of a Randomized Controlled Trial.

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Astrid V Fahlenkamp

Full Text Available Like other inhalational anesthetics xenon seems to be associated with post-operative nausea and vomiting (PONV. We assessed nausea incidence following balanced xenon anesthesia compared to sevoflurane, and dexamethasone for its prophylaxis in a randomized controlled trial with post-hoc explorative analysis.220 subjects with elevated PONV risk (Apfel score ≥2 undergoing elective abdominal surgery were randomized to receive xenon or sevoflurane anesthesia and dexamethasone or placebo after written informed consent. 93 subjects in the xenon group and 94 subjects in the sevoflurane group completed the trial. General anesthesia was maintained with 60% xenon or 2.0% sevoflurane. Dexamethasone 4mg or placebo was administered in the first hour. Subjects were analyzed for nausea and vomiting in predefined intervals during a 24h post-anesthesia follow-up.Logistic regression, controlled for dexamethasone and anesthesia/dexamethasone interaction, showed a significant risk to develop nausea following xenon anesthesia (OR 2.30, 95% CI 1.02-5.19, p = 0.044. Early-onset nausea incidence was 46% after xenon and 35% after sevoflurane anesthesia (p = 0.138. After xenon, nausea occurred significantly earlier (p = 0.014, was more frequent and rated worse in the beginning. Dexamethasone did not markedly reduce nausea occurrence in both groups. Late-onset nausea showed no considerable difference between the groups.In our study setting, xenon anesthesia was associated with an elevated risk to develop nausea in sensitive subjects. Dexamethasone 4mg was not effective preventing nausea in our study. Group size or dosage might have been too small, and change of statistical analysis parameters in the post-hoc evaluation might have further contributed to a limitation of our results. Further trials will be needed to address prophylaxis of xenon-induced nausea.EU Clinical Trials EudraCT-2008-004132-20 ClinicalTrials.gov NCT00793663.

Pharmaceutical companies vs. the State: who is responsible for post-trial provision of drugs in Brazil?

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Wang, Daniel Wei L; Ferraz, Octavio Luiz Motta

2012-01-01

This paper discusses the post-trial access to drugs for patients who participated in clinical trials in Brazil. The ethical guidance for clinical trials in Brazil is arguably one of the clearest in the world in attributing to research sponsors the responsibility for providing post-trial drugs to patients who participated in their experiments. The Federal Constitution recognizes health as a fundamental right to be fulfilled by the State. Based on the Brazilian constitution and on the National Health Council resolutions, courts have been accepting patients' claims and ordering the State and the pharmaceutical companies to provide these patients with the tested treatment in the quantity and duration they need it. This generous interpretation of the duties of the pharmaceutical companies and the State makes the Brazilian model for post-trial access unique when compared to the experience of other countries and thus should be followed with attention by future research in order to assess its consequences for patients, research sponsors, and the public health system. © 2012 American Society of Law, Medicine & Ethics, Inc.

Treatment of post-myocardial infarction depressive disorder : A randomized, placebo-controlled trial with mirtazapine

NARCIS (Netherlands)

Honig, Adriaan; Kuyper, Astrid M. G.; Schene, Aart H.; van Melle, Joost P.; De Jonge, Peter; Tulner, Dorien M.; Schins, Annique; Crijns, Harry J. G. M.; Kuijpers, Petra M. J. C.; Vossen, Helen; Lousberg, Richel; Ormel, Johan

Objective: To examine the antidepressant efficacy of a dual-acting antidepressant (mirtazapine) in patients with post-myocardial infarction (MI) depressive disorder. Antidepressants used in post MI trials with a randomized, double-blind, placebo-controlled design have been restricted to selective

From rehabilitation to recovery: protocol for a randomised controlled trial evaluating a goal-based intervention to reduce depression and facilitate participation post-stroke.

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Graven, Christine; Brock, Kim; Hill, Keith; Ames, David; Cotton, Susan; Joubert, Lynette

2011-06-18

There is much discourse in healthcare about the importance of client-centred rehabilitation, however in the realm of community-based therapy post-stroke there has been little investigation into the efficacy of goal-directed practice that reflects patients' valued activities. In addition, the effect of active involvement of carers in such a rehabilitation process and their subsequent contribution to functional and emotional recovery post-stroke is unclear. In community based rehabilitation, interventions based on patients' perceived needs may be more likely to alter such outcomes. In this paper, we describe the methodology of a randomised controlled trial of an integrated approach to facilitating patient goal achievement in the first year post-stroke. The effectiveness of this intervention in reducing the severity of post-stroke depression, improving participation status and health-related quality of life is examined. The impact on carers is also examined. Patients (and their primary carers, if available) are randomly allocated to an intervention or control arm of the study. The intervention is multimodal and aims to screen for adverse stroke sequelae and address ways to enhance participation in patient-valued activities. Intervention methods include: telephone contacts, written information provision, home visitation, and contact with treating health professionals, with further relevant health service referrals as required. The control involves treatment as usual, as determined by inpatient and community rehabilitation treating teams. Formal blinded assessments are conducted at discharge from inpatient rehabilitation, and at six and twelve months post-stroke. The primary outcome is depression. Secondary outcome measures include participation and activity status, health-related quality of life, and self-efficacy. The results of this trial will assist with the development of a model for community-based rehabilitation management for stroke patients and their carers

A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis.

Science.gov (United States)

Elmunzer, B Joseph; Scheiman, James M; Lehman, Glen A; Chak, Amitabh; Mosler, Patrick; Higgins, Peter D R; Hayward, Rodney A; Romagnuolo, Joseph; Elta, Grace H; Sherman, Stuart; Waljee, Akbar K; Repaka, Aparna; Atkinson, Matthew R; Cote, Gregory A; Kwon, Richard S; McHenry, Lee; Piraka, Cyrus R; Wamsteker, Erik J; Watkins, James L; Korsnes, Sheryl J; Schmidt, Suzette E; Turner, Sarah M; Nicholson, Sylvia; Fogel, Evan L

2012-04-12

Preliminary research suggests that rectally administered nonsteroidal antiinflammatory drugs may reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). In this multicenter, randomized, placebo-controlled, double-blind clinical trial, we assigned patients at elevated risk for post-ERCP pancreatitis to receive a single dose of rectal indomethacin or placebo immediately after ERCP. Patients were determined to be at high risk on the basis of validated patient- and procedure-related risk factors. The primary outcome was post-ERCP pancreatitis, which was defined as new upper abdominal pain, an elevation in pancreatic enzymes to at least three times the upper limit of the normal range 24 hours after the procedure, and hospitalization for at least 2 nights. A total of 602 patients were enrolled and completed follow-up. The majority of patients (82%) had a clinical suspicion of sphincter of Oddi dysfunction. Post-ERCP pancreatitis developed in 27 of 295 patients (9.2%) in the indomethacin group and in 52 of 307 patients (16.9%) in the placebo group (P=0.005). Moderate-to-severe pancreatitis developed in 13 patients (4.4%) in the indomethacin group and in 27 patients (8.8%) in the placebo group (P=0.03). Among patients at high risk for post-ERCP pancreatitis, rectal indomethacin significantly reduced the incidence of the condition. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00820612.).

Effect of lactobacillus in preventing post-antibiotic vulvovaginal candidiasis: a randomised controlled trial

Science.gov (United States)

Pirotta, Marie; Gunn, Jane; Chondros, Patty; Grover, Sonia; O'Malley, Paula; Hurley, Susan; Garland, Suzanne

2004-01-01

Objective To test whether oral or vaginal lactobacillus can prevent vulvovaginitis after antibiotic treatment. Design Randomised, placebo controlled, double blind, factorial 2×2 trial. Setting Fifty general practices and 16 pharmacies in Melbourne, Australia. Participants Non-pregnant women aged 18-50 years who required a short course of oral antibiotics for a non-gynaecological infection: 278 were enrolled in the study, and results were available for 235. Interventions Lactobacillus preparations taken orally or vaginally, or both, from enrolment until four days after completion of their antibiotic course. Main outcome measures Participants' reports of symptoms of post-antibiotic vulvovaginitis, with microbiological evidence of candidiasis provided by a self obtained vaginal swab. Results Overall, 55/235 (23% (95% confidence interval 18% to 29%)) women developed post-antibiotic vulvovaginitis. Compared with placebo, the odds ratio for developing post-antibiotic vulvovaginitis with oral lactobacillus was 1.06 (95% confidence interval 0.58 to 1.94) and with vaginal lactobacillus 1.38 (0.75 to 2.54). Compliance with antibiotics and interventions was high. The trial was terminated after the second interim analysis because of lack of effect of the interventions. Given the data at this time, the chances of detecting a significant reduction in vulvovaginitis with oral or vaginal lactobacillus treatment were less than 0.032 and 0.0006 respectively if the trial proceeded to full enrolment. Conclusions The use of oral or vaginal forms of lactobacillus to prevent post-antibiotic vulvovaginitis is not supported by these results. Further research on this subject is unlikely to be fruitful, unless new understandings about the pathogenesis of post-antibiotic vulvovaginitis indicate a possible role for lactobacillus. PMID:15333452

Brexanolone (SAGE-547 injection) in post-partum depression: a randomised controlled trial.

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Kanes, Stephen; Colquhoun, Helen; Gunduz-Bruce, Handan; Raines, Shane; Arnold, Ryan; Schacterle, Amy; Doherty, James; Epperson, C Neill; Deligiannidis, Kristina M; Riesenberg, Robert; Hoffmann, Ethan; Rubinow, David; Jonas, Jeffrey; Paul, Steven; Meltzer-Brody, Samantha

2017-07-29

Post-partum depression is a serious mood disorder in women that might be triggered by peripartum fluctuations in reproductive hormones. This phase 2 study investigated brexanolone (USAN; formerly SAGE-547 injection), an intravenous formulation of allopregnanolone, a positive allosteric modulator of γ-aminobutyric acid (GABA A ) receptors, for the treatment of post-partum depression. For this double-blind, randomised, placebo-controlled trial, we enrolled self-referred or physician-referred female inpatients (≤6 months post partum) with severe post-partum depression (Hamilton Rating Scale for Depression [HAM-D] total score ≥26) in four hospitals in the USA. Eligible women were randomly assigned (1:1), via a computer-generated randomisation program, to receive either a single, continuous intravenous dose of brexanolone or placebo for 60 h. Patients and investigators were masked to treatment assignments. The primary efficacy endpoint was the change from baseline in the 17-item HAM-D total score at 60 h, assessed in all randomised patients who started infusion of study drug or placebo and who had a completed baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Patients were followed up until day 30. This trial is registered with ClinicalTrials.gov, number NCT02614547. This trial was done between Dec 15, 2015 (first enrolment), and May 19, 2016 (final visit of the last enrolled patient). 21 women were randomly assigned to the brexanolone (n=10) and placebo (n=11) groups. At 60 h, mean reduction in HAM-D total score from baseline was 21·0 points (SE 2·9) in the brexanolone group compared with 8·8 points (SE 2·8) in the placebo group (difference -12·2, 95% CI -20·77 to -3·67; p=0·0075; effect size 1·2). No deaths, serious adverse events, or discontinuations because of adverse events were reported in either group. Four of ten patients in the brexanolone group had adverse events compared with eight of 11 in the placebo group. The most

The effectiveness of an augmented cognitive behavioural intervention for post-stroke depression with or without anxiety (PSDA: the Restore4Stroke-PSDA trial

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Kootker Joyce A

2012-07-01

Full Text Available Abstract Background Post-Stroke Depression with or without Anxiety (PSDA is a common disorder in the chronic phase of stroke. Neuropsychiatric problems, such as PSDA, have a negative impact on social reintegration and quality of life. Currently, there is no evidence-based treatment available for reducing PSDA symptoms. In the recent literature on depression in the general population it has been shown that depression complaints can diminish by cognitive behavioural therapy (CBT. In the current study, the effectiveness of augmented, activation-based and individually tailored CBT on the reduction of depression and anxiety will be investigated in patients with PSDA. Additionally, the effects on various secondary outcome measures, such as quality of life, goal attainment and societal participation will be evaluated. This study is embedded in a consortium of 4 interrelated studies on quality of life after stroke (Restore4Stroke. Methods/design A multi-centre, assessor-blind, randomized controlled trial is conducted. A sample of 106 PSDA patients, as assessed with the Hospital Anxiety and Depression Scale (HADS depression subscale >7, will be recruited and randomly allocated to either an experimental or a control group. The experimental intervention consists of an augmented CBT intervention. The intervention is based on CBT principles of recognizing, registering, and altering negative thoughts and cognitions so that mood, and emotional symptoms are improved. CBT is augmented with direct in-vivo activation offered by occupational or movement therapists. Patients in the control group will receive a computerized cognitive training intervention. Outcomes will be assessed at baseline, immediately post intervention, and at 6 and 12 months follow up. Discussion This study is the first randomized clinical trial that evaluates the (maintenance of effects of augmented CBT on post-stroke depression with or without anxiety symptoms. Together with three other

Effectiveness of compression stockings to prevent the post-thrombotic syndrome (The SOX Trial and Bio-SOX biomarker substudy: a randomized controlled trial

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Rodger Marc A

2007-07-01

Full Text Available Abstract Background Post thrombotic syndrome (PTS is a burdensome and costly complication of deep venous thrombosis (DVT that develops in 20–40% of patients within 1–2 years after symptomatic DVT. Affected patients have chronic leg pain and swelling and may develop ulcers. Venous valve disruption from the thrombus itself or thrombus-associated mediators of inflammation is considered to be a key initiating event for the development of venous hypertension that often underlies PTS. As existing treatments for PTS are extremely limited, strategies that focus on preventing the development of PTS in patients with DVT are more likely to be effective and cost-effective in reducing its burden. Elastic compression stockings (ECS could be helpful in preventing PTS; however, data on their effectiveness are scarce and conflicting. Methods/Design The SOX Trial is a randomized, allocation concealed, double-blind multicenter clinical trial. The objective of the study is to evaluate ECS to prevent PTS. A total of 800 patients with proximal DVT will be randomized to one of 2 treatment groups: ECS or placebo (inactive stockings worn on the DVT-affected leg daily for 2 years. The primary outcome is the incidence of PTS during follow-up. Secondary outcomes are severity of PTS, venous thromboembolism (VTE recurrence, death from VTE, quality of life and cost-effectiveness. Outcomes will be evaluated during 6 clinic visits and 2 telephone follow ups. At baseline, 1 and 6 months, blood samples will be obtained to evaluate the role of inflammatory mediators and genetic markers of thrombophilia in the development of PTS (Bio-SOX substudy. Discussion The SOX Trial will be the largest study and the first with a placebo control to evaluate the effectiveness of ECS to prevent PTS. It is designed to provide definitive data on the effects of ECS on the occurrence and severity of PTS, as well as DVT recurrence, cost-effectiveness and quality of life. This study will also

Center-Within-Trial Versus Trial-Level Evaluation of Surrogate Endpoints

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Renfro, Lindsay A.; Shi, Qian; Xue, Yuan; Li, Junlong; Shang, Hongwei; Sargent, Daniel J.

2014-01-01

Evaluation of candidate surrogate endpoints using individual patient data from multiple clinical trials is considered the gold standard approach to validate surrogates at both patient and trial levels. However, this approach assumes the availability of patient-level data from a relatively large collection of similar trials, which may not be possible to achieve for a given disease application. One common solution to the problem of too few similar trials involves performing trial-level surrogacy analyses on trial sub-units (e.g., centers within trials), thereby artificially increasing the trial-level sample size for feasibility of the multi-trial analysis. To date, the practical impact of treating trial sub-units (centers) identically to trials in multi-trial surrogacy analyses remains unexplored, and conditions under which this ad hoc solution may in fact be reasonable have not been identified. We perform a simulation study to identify such conditions, and demonstrate practical implications using a multi-trial dataset of patients with early stage colon cancer. PMID:25061255

Rectally administered indomethacin to prevent post-ESWL-pancreatitis (RIPEP): study protocol for a randomized controlled trial.

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Qian, Yang-Yang; Chen, Hui; Tang, Xin-Ying; Jiang, Xi; Qian, Wei; Zou, Wen-Bin; Xin, Lei; Li, Bo; Qi, Yan-Fen; Hu, Liang-Hao; Zou, Duo-Wu; Jin, Zhen-Dong; Wang, Dong; Du, Yi-Qi; Wang, Luo-Wei; Liu, Feng; Li, Zhao-Shen; Liao, Zhuan

2017-11-02

Pancreatic extracorporeal shock wave lithotripsy (P-ESWL) is the first-line therapy for large pancreatic duct stones. Although it is a highly effective and safe procedure for the fragmentation of pancreatic stones, it is still not complication-free. Just like endoscopic retrograde cholangiopancreatography (ERCP), pancreatitis is the most common complication. To date, nonsteroidal anti-inflammatory drugs (NSAIDs) have proven to be the only effective prophylactic medication for post-ERCP pancreatitis and the European, American and Japanese Society for Gastrointestinal Endoscopy guidelines have recommended prophylactic rectally administered indomethacin for all patients undergoing ERCP. Given the little research about effective prevention for post P-ESWL pancreatitis, we aim to determine whether rectally administered indomethacin can reduce post-ESWL-pancreatitis. The RIPEP study is a prospective, randomized, double-blinded, placebo-controlled trial. One thousand three hundred and seventy patients with chronic pancreatitis and pancreatic stones (>5 mm in diameter) treated with P-ESWL at Changhai Hospital will be randomly allocated to rectally administered indomethacin or placebo therapy before the procedure. The primary endpoint is the incidence of post-ESWL pancreatitis. Secondary endpoints include the severity of pancreatitis, occurrence rate of asymptomatic hyperamylasemia and other complications. The RIPEP trial is designed to show that rectally administered indomethacin reduces the development and severity of post-ESWL pancreatitis and benefits patients treated with P-ESWL. ClinicalTrials.gov, ID: NCT02797067 . Registered on 17 November 2016.

Evaluating biomarkers for prognostic enrichment of clinical trials.

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Kerr, Kathleen F; Roth, Jeremy; Zhu, Kehao; Thiessen-Philbrook, Heather; Meisner, Allison; Wilson, Francis Perry; Coca, Steven; Parikh, Chirag R

2017-12-01

A potential use of biomarkers is to assist in prognostic enrichment of clinical trials, where only patients at relatively higher risk for an outcome of interest are eligible for the trial. We investigated methods for evaluating biomarkers for prognostic enrichment. We identified five key considerations when considering a biomarker and a screening threshold for prognostic enrichment: (1) clinical trial sample size, (2) calendar time to enroll the trial, (3) total patient screening costs and the total per-patient trial costs, (4) generalizability of trial results, and (5) ethical evaluation of trial eligibility criteria. Items (1)-(3) are amenable to quantitative analysis. We developed the Biomarker Prognostic Enrichment Tool for evaluating biomarkers for prognostic enrichment at varying levels of screening stringency. We demonstrate that both modestly prognostic and strongly prognostic biomarkers can improve trial metrics using Biomarker Prognostic Enrichment Tool. Biomarker Prognostic Enrichment Tool is available as a webtool at http://prognosticenrichment.com and as a package for the R statistical computing platform. In some clinical settings, even biomarkers with modest prognostic performance can be useful for prognostic enrichment. In addition to the quantitative analysis provided by Biomarker Prognostic Enrichment Tool, investigators must consider the generalizability of trial results and evaluate the ethics of trial eligibility criteria.

Hyperbaric oxygen for post-concussive symptoms in United States military service members: a randomized clinical trial.

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Weaver, Lindell K; Wilson, Steffanie H; Lindblad, Anne S; Churchill, Susan; Deru, Kayla; Price, Robert C; Williams, Chris S; Orrison, William W; Walker, James M; Meehan, Anna; Mirow, Susan

2018-01-01

In prior military randomized trials, participants with persistent symptoms after mild traumatic brain injury (TBI) reported improvement regardless of receiving hyperbaric oxygen (HBO₂) or sham intervention. This study's objectives were to identify outcomes for future efficacy trials and describe changes by intervention. This Phase II, randomized, double-blind, sham-controlled trial enrolled military personnel with mild TBI and persistent post-concussive symptoms. Participants were randomized to receive 40 HBO₂ (1.5 atmospheres absolute (ATA), ⟩99% oxygen, 60 minutes) or sham chamber sessions (1.2 ATA, room air, 60 minutes) over 12 weeks. Participants and evaluators were blinded to allocation. Outcomes assessed at baseline, 13 weeks and six months included symptoms, quality of life, neuropsychological, neurological, electroencephalography, sleep, auditory, vestibular, autonomic, visual, neuroimaging, and laboratory testing. Participants completed 12-month questionnaires. Intention-to-treat results are reported. From 9/11/2012 to 5/19/2014, 71 randomized participants received HBO₂ (n=36) or sham (n=35). At baseline, 35 participants (49%) met post-traumatic stress disorder (PTSD) criteria. By the Neurobehavioral Symptom Inventory, the HBO₂ group had improved 13-week scores (mean change -3.6 points, P=0.03) compared to sham (+3.9 points). In participants with PTSD, change with HBO₂ was more pronounced (-8.6 vs. +4.8 points with sham, P=0.02). PTSD symptoms also improved in the HBO₂ group, and more so in the subgroup with PTSD. Improvements regressed at six and 12 months. Hyperbaric oxygen improved some cognitive processing speed and sleep measures. Participants with PTSD receiving HBO₂ had improved functional balance and reduced vestibular complaints at 13 weeks. By 13 weeks, HBO₂ improved post-concussive and PTSD symptoms, cognitive processing speed, sleep quality, and balance function, most dramatically in those with PTSD. Changes did not persist

The post hoc use of randomised controlled trials to explore drug associated cancer outcomes

DEFF Research Database (Denmark)

Stefansdottir, Gudrun; Zoungas, Sophia; Chalmers, John

2013-01-01

on public health before proper regulatory action can be taken. This paper aims to discuss challenges of exploring drug-associated cancer outcomes by post-hoc analyses of Randomised controlled trials (RCTs) designed for other purposes. METHODOLOGICAL CHALLENGES TO CONSIDER: We set out to perform a post......-hoc nested case-control analysis in the ADVANCE trial in order to examine the association between insulin use and cancer. We encountered several methodological challenges that made the results difficult to interpret, including short duration of exposure of interest, lack of power, and correlation between...... exposure and potential confounders. Considering these challenges, we concluded that using the data would not enlighten the discussion about insulin use and cancer risk and only serve to further complicate any understanding. Therefore, we decided to use our experience to illustrate methodological challenges...

Post-trial apomorphine at an autoreceptor dose level can eliminate apomorphine conditioning and sensitization: support for the critical role of dopamine in re-consolidation.

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Carrera, Marinete Pinheiro; Carey, Robert J; Cruz Dias, Flávia Regina; dos Santos Sampaio, Maria de Fátima; de Matos, Liana Wermelinger

2013-01-01

Re-exposure to conditioned drug stimuli triggers re-consolidation processes. In the present study post-trial apomorphine treatments were administered in order to interact with the re-consolidation of an apomorphine conditioned/sensitized locomotor response. A low (0.05 mg/kg) and a high (2.0mg/kg) dose were used to inhibit or to enhance dopamine activity, respectively. Initially, groups received 5 daily apomorphine (2.0mg/kg)/vehicle treatments either paired or unpaired to open-field placement. The paired treatments generated a progressive locomotor response. Subsequently, all groups received a 5 min non-drug test for conditioning and a conditioned locomotor response was observed in the paired group. The groups received another apomorphine (2.0mg/kg)/vehicle treatment as a re-induction treatment. At this stage the post-trial protocol was initiated. One set of paired, unpaired and vehicle groups were given a low dose of apomorphine (0.05 mg/kg) post-trial; another set received a high dose of apomorphine (2.0mg/kg) post-trial. The remaining group set received vehicle post-trial. The low dose post-trial treatment eliminated the conditioned and sensitized locomotor response and the high dose post-trial treatment enhanced the conditioned and sensitized locomotor response. The efficacy of the post-trial apomorphine treatments to modify the conditioned and the sensitized response after a brief non-drug exposure to test cues supports the proposition that exteroceptive cues control conditioning and sensitization and that the interoceptive drug cues make little or no associational contribution to apomorphine conditioning and sensitization. In addition, the findings point to the importance of dopamine activation in both the acquisition and re-consolidation of conditioning processes. Copyright © 2012 Elsevier B.V. All rights reserved.

Rehab-let: touchscreen tablet for self-training impaired dexterity post stroke: study protocol for a pilot randomized controlled trial.

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Rand, Debbie; Zeilig, Gabi; Kizony, Rachel

2015-06-18

Impaired dexterity of the weaker upper extremity is common post stroke and it is recommended that these individuals practice many repetitions of movement to regain function. However, stroke rehabilitation methods do not achieve the required intensity to be effective. Touchscreen tablet technology may be used as a motivating tool for self-training impaired dexterity of the weaker upper extremity post stroke. Rehab-let is a self-training protocol utilizing game apps on a touchscreen for practicing movement of the weaker upper extremity. We will conduct a pilot randomized controlled trial to assess Rehab-let compared to traditional self-training to improve dexterity of the weaker hand, and to increase self-training time and satisfaction in individuals with subacute stroke. Forty individuals with stroke undergoing subacute rehabilitation will be randomly allocated to Rehab-let or a traditional self-training program using therapeutic aids such as balls, blocks and pegs. All participants will be requested to perform self-training for 60 minutes a day, 5 times a week for 4 weeks. Dexterity assessed by The Nine Hole Peg Test is the main outcome measure. Assessments will be administered pre and post the self-training intervention by assessors blind to the group allocation. The outcomes of this study will inform the design of a fully powered randomized controlled trial to evaluate the effectiveness of Rehab-let. If found to be effective, Rehab-let can be used during subacute rehabilitation to increase treatment intensity and improve dexterity. Potentially, Rehab-let can also be used after discharge and might be ideal for individuals with mild stroke who are often not referred to formal rehabilitation. Current Controlled Trials NCT02136433 registered on 17 September 2014.

Hyperbaric oxygen therapy can improve post concussion syndrome years after mild traumatic brain injury - randomized prospective trial.

Directory of Open Access Journals (Sweden)

Rahav Boussi-Gross

Full Text Available Traumatic brain injury (TBI is the leading cause of death and disability in the US. Approximately 70-90% of the TBI cases are classified as mild, and up to 25% of them will not recover and suffer chronic neurocognitive impairments. The main pathology in these cases involves diffuse brain injuries, which are hard to detect by anatomical imaging yet noticeable in metabolic imaging. The current study tested the effectiveness of Hyperbaric Oxygen Therapy (HBOT in improving brain function and quality of life in mTBI patients suffering chronic neurocognitive impairments.The trial population included 56 mTBI patients 1-5 years after injury with prolonged post-concussion syndrome (PCS. The HBOT effect was evaluated by means of prospective, randomized, crossover controlled trial: the patients were randomly assigned to treated or crossover groups. Patients in the treated group were evaluated at baseline and following 40 HBOT sessions; patients in the crossover group were evaluated three times: at baseline, following a 2-month control period of no treatment, and following subsequent 2-months of 40 HBOT sessions. The HBOT protocol included 40 treatment sessions (5 days/week, 60 minutes each, with 100% oxygen at 1.5 ATA. "Mindstreams" was used for cognitive evaluations, quality of life (QOL was evaluated by the EQ-5D, and changes in brain activity were assessed by SPECT imaging. Significant improvements were demonstrated in cognitive function and QOL in both groups following HBOT but no significant improvement was observed following the control period. SPECT imaging revealed elevated brain activity in good agreement with the cognitive improvements.HBOT can induce neuroplasticity leading to repair of chronically impaired brain functions and improved quality of life in mTBI patients with prolonged PCS at late chronic stage.ClinicalTrials.gov NCT00715052.

Hyperbaric oxygen therapy can improve post concussion syndrome years after mild traumatic brain injury - randomized prospective trial.

Science.gov (United States)

Boussi-Gross, Rahav; Golan, Haim; Fishlev, Gregori; Bechor, Yair; Volkov, Olga; Bergan, Jacob; Friedman, Mony; Hoofien, Dan; Shlamkovitch, Nathan; Ben-Jacob, Eshel; Efrati, Shai

2013-01-01

Traumatic brain injury (TBI) is the leading cause of death and disability in the US. Approximately 70-90% of the TBI cases are classified as mild, and up to 25% of them will not recover and suffer chronic neurocognitive impairments. The main pathology in these cases involves diffuse brain injuries, which are hard to detect by anatomical imaging yet noticeable in metabolic imaging. The current study tested the effectiveness of Hyperbaric Oxygen Therapy (HBOT) in improving brain function and quality of life in mTBI patients suffering chronic neurocognitive impairments. The trial population included 56 mTBI patients 1-5 years after injury with prolonged post-concussion syndrome (PCS). The HBOT effect was evaluated by means of prospective, randomized, crossover controlled trial: the patients were randomly assigned to treated or crossover groups. Patients in the treated group were evaluated at baseline and following 40 HBOT sessions; patients in the crossover group were evaluated three times: at baseline, following a 2-month control period of no treatment, and following subsequent 2-months of 40 HBOT sessions. The HBOT protocol included 40 treatment sessions (5 days/week), 60 minutes each, with 100% oxygen at 1.5 ATA. "Mindstreams" was used for cognitive evaluations, quality of life (QOL) was evaluated by the EQ-5D, and changes in brain activity were assessed by SPECT imaging. Significant improvements were demonstrated in cognitive function and QOL in both groups following HBOT but no significant improvement was observed following the control period. SPECT imaging revealed elevated brain activity in good agreement with the cognitive improvements. HBOT can induce neuroplasticity leading to repair of chronically impaired brain functions and improved quality of life in mTBI patients with prolonged PCS at late chronic stage. ClinicalTrials.gov NCT00715052.

Post-licence driver education for the prevention of road traffic crashes: a systematic review of randomised controlled trials.

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Ker, Katharine; Roberts, Ian; Collier, Timothy; Beyer, Fiona; Bunn, Frances; Frost, Chris

2005-03-01

The effectiveness of post-licence driver education for preventing road traffic crashes was quantified using a systematic review and meta-analyses of randomised controlled trials. Searches of appropriate electronic databases, the Internet and reference lists of relevant papers were conducted. The searches were not restricted by language or publication status. Data were pooled from 21 randomised controlled trials, including over 300,000 full licence-holding drivers of all ages. Nineteen trials reported subsequent traffic offences, with a pooled relative risk of 0.96 (95% confidence interval 0.94, 0.98). Fifteen trials reported traffic crashes with a pooled relative risk of 0.98 (0.96, 1.01). Four trials reported injury crashes with a pooled relative risk of 1.12 (0.88, 1.41). The results provide no evidence that post-licence driver education is effective in preventing road injuries or crashes. Although the results are compatible with a small reduction in the occurrence of traffic crashes, this may be due to selection biases or bias in the included trials.

Post-use assay of vaginal rings (VRs) as a potential measure of clinical trial adherence.

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Spence, Patrick; Nel, Annalene; van Niekerk, Neliëtte; Derrick, Tiffany; Wilder, Susan; Devlin, Bríd

2016-06-05

Adherence measurement for microbicide use within the clinical trial setting remains a challenge for the HIV prevention field. This paper describes an assay method used for determining residual dapivirine levels in post-use vaginal rings from clinical trials conducted with the Dapivirine Vaginal Matrix Ring-004 developed by the International Partnership for Microbicides to prevent male to female HIV transmission. Post-use assay results from three Ring-004 clinical trials showed that of the 25mg drug load, approximately 4mg of dapivirine is released from the matrix ring over a 28-day use period. Data obtained by both in vitro and in vivo studies indicate that dapivirine is released according to a diffusion mechanism, as determined by conformance of both data sets to the Higuchi equation. This, coupled with the low variability associated with batch production over two manufacturing sites and 20 batches of material, provides evidence that post-use ring analysis can contribute to the assessment of adherence to ring use. Limitations of this method include the potential of intra-participant and inter-participant variability and uncertainty associated with measuring the low amount of dapivirine actually released relative to the drug load. Therefore, residual drug levels should not serve as the only direct measurement for microbicide adherence in vaginal ring clinical trials but should preferably be used as part of a multi-pronged approach towards understanding and assessing adherence to vaginal ring use. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

Wound infiltration with local anesthetics for post-operative pain relief in lumbar spine surgery

DEFF Research Database (Denmark)

Kjærgaard, M; Møiniche, S; Olsen, K S

2012-01-01

In this systematic review, we evaluated double-blind, randomized and controlled trials on the effect of wound infiltration with local anesthetics compared with the effect of placebo on post-operative pain after lumbar spine surgery.......In this systematic review, we evaluated double-blind, randomized and controlled trials on the effect of wound infiltration with local anesthetics compared with the effect of placebo on post-operative pain after lumbar spine surgery....

Solid oxide fuel cell field trial evaluation

Energy Technology Data Exchange (ETDEWEB)

Wilcox, C.P.; Winstanley, R.; Nietsch, T.; Smith, C.; Knight, R.; Seymore, C.

2000-07-01

This report focuses on issues relating to a field trial of a solid oxide fuel cell (SOFC). Aspects examined include markets for SOFC systems, the choice of systems for demonstration in year 2002, the assessment of industrial interest, and evaluation and ranking of candidate systems. The identification and evaluation of interest in field trials, the estimation of the capital and running costs of a field trial, and identification of the benefits to the UK and barriers to implementation of SOFC systems are discussed. (UK)

Reducing depressive or anxiety symptoms in post-stroke patients: Pilot trial of a constructive integrative psychosocial intervention

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Fang, Yihong; Mpofu, Elias; Athanasou, James

2017-01-01

Background: About 30% of stroke survivors clinically have depressive symptoms at some point following stroke and anxiety prevalence is around 20-25%. Objective: The purpose of this brief report is to evaluate a pilot trial of a constructive integrative psychosocial intervention (CIPI) over standard care in post-stroke depression or anxiety. Methods: Patients were randomly assigned to either CIPI (n = 23) or standard care (n = 19). Patients were assessed using the Hospital Anxiety and Depression Scale at the 1st, 3rd, and 6th months to monitor changes of mood. Results: A Wilcoxon signed-rank test indicated that compared to admission baseline, patients with the intervention had significantly normal post-stroke depression symptom levels at the 1st, 3rd, and 6th months (P < 0.005). Conclusion: CIPI appears to be of incremental value in treating depression as well as anxiety in subacute care. PMID:29085269

A randomised controlled trial evaluating family mediated exercise (FAME therapy following stroke

Directory of Open Access Journals (Sweden)

Stokes Emma

2008-06-01

Full Text Available Abstract Background Stroke is a leading cause of disability among adults worldwide. Evidence suggests that increased duration of exercise therapy following stroke has a positive impact on functional outcome following stroke. The main objective of this randomised controlled trial is to evaluate the impact of additional family assisted exercise therapy in people with acute stroke. Methods/Design A prospective multi-centre single blind randomised controlled trial will be conducted. Forty patients with acute stroke will be randomised into either an experimental or control group. The experimental group will receive routine therapy and additional lower limb exercise therapy in the form of family assisted exercises. The control group will receive routine therapy with no additional formal input from their family members. Participants will be assessed at baseline, post intervention and followed up at three months using a series of standardised outcome measures. A secondary aim of the project is to evaluate the impact of the family mediated exercise programme on the person with stroke and the individual(s assisting in the delivery of exercises using a qualitative methodology. The study has gained ethical approval from the Research Ethics Committees of each of the clinical sites involved in the study. Discussion This study will evaluate a structured programme of exercises that can be delivered to people with stroke by their 'family members/friends'. Given that the progressive increase in the population of older people is likely to lead to an increased prevalence of stroke in the future, it is important to reduce the burden of this illness on the individual, the family and society. Family mediated exercises can maximise the carry over outside formal physiotherapy sessions, giving patients the opportunity for informal practice. Trial Registration The protocol for this study is registered with the US NIH Clinical trials registry (NCT00666744

Defining, evaluating, and removing bias induced by linear imputation in longitudinal clinical trials with MNAR missing data.

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Helms, Ronald W; Reece, Laura Helms; Helms, Russell W; Helms, Mary W

2011-03-01

Missing not at random (MNAR) post-dropout missing data from a longitudinal clinical trial result in the collection of "biased data," which leads to biased estimators and tests of corrupted hypotheses. In a full rank linear model analysis the model equation, E[Y] = Xβ, leads to the definition of the primary parameter β = (X'X)(-1)X'E[Y], and the definition of linear secondary parameters of the form θ = Lβ = L(X'X)(-1)X'E[Y], including, for example, a parameter representing a "treatment effect." These parameters depend explicitly on E[Y], which raises the questions: What is E[Y] when some elements of the incomplete random vector Y are not observed and MNAR, or when such a Y is "completed" via imputation? We develop a rigorous, readily interpretable definition of E[Y] in this context that leads directly to definitions of β, Bias(β) = E[β] - β, Bias(θ) = E[θ] - Lβ, and the extent of hypothesis corruption. These definitions provide a basis for evaluating, comparing, and removing biases induced by various linear imputation methods for MNAR incomplete data from longitudinal clinical trials. Linear imputation methods use earlier data from a subject to impute values for post-dropout missing values and include "Last Observation Carried Forward" (LOCF) and "Baseline Observation Carried Forward" (BOCF), among others. We illustrate the methods of evaluating, comparing, and removing biases and the effects of testing corresponding corrupted hypotheses via a hypothetical but very realistic longitudinal analgesic clinical trial.

Optimised anaesthesia to reduce post operative cognitive decline (POCD in older patients undergoing elective surgery, a randomised controlled trial.

Directory of Open Access Journals (Sweden)

Clive Ballard

Full Text Available BACKGROUND: The study determined the one year incidence of post operative cognitive decline (POCD and evaluated the effectiveness of an intra-operative anaesthetic intervention in reducing post-operative cognitive impairment in older adults (over 60 years of age undergoing elective orthopaedic or abdominal surgery. METHODS AND TRIAL DESIGN: The design was a prospective cohort study with a nested randomised, controlled intervention trial, using intra-operative BiSpectral index and cerebral oxygen saturation monitoring to enable optimisation of anaesthesia depth and cerebral oxygen saturation in older adults undergoing surgery. RESULTS: In the 52 week prospective cohort study (192 surgical patients and 138 controls, mild (χ(2 = 17.9 p<0.0001, moderate (χ(2 = 7.8 p = 0.005 and severe (χ(2 = 5.1 p = 0.02 POCD were all significantly higher after 52 weeks in the surgical patients than among the age matched controls. In the nested RCT, 81 patients were randomized, 73 contributing to the data analysis (34 intervention, 39 control. In the intervention group mild POCD was significantly reduced at 1, 12 and 52 weeks (Fisher's Exact Test p = 0.018, χ(2 = 5.1 p = 0.02 and χ(2 = 5.9 p = 0.015, and moderate POCD was reduced at 1 and 52 weeks (χ(2 = 4.4 p = 0·037 and χ(2 = 5.4 p = 0.02. In addition there was significant improvement in reaction time at all time-points (Vigilance Reaction Time MWU Z = -2.1 p = 0.03, MWU Z = -2.7 p = 0.004, MWU Z = -3.0 p = 0.005, in MMSE at one and 52 weeks (MWU Z = -2.9 p = 0.003, MWU Z = -3.3 p = 0.001, and in executive function at 12 and 52 weeks (Trail Making MWU Z = -2.4 p = .0.018, MWU Z = -2.4 p = 0.019. CONCLUSION: POCD is common and persistent in older adults following surgery. The results of the nested RCT indicate the potential benefits of intra-operative monitoring of anaesthetic depth and cerebral oxygenation as a pragmatic intervention to reduce post-operative cognitive impairment. TRIAL REGISTRATION

Developments in statistical evaluation of clinical trials

CERN Document Server

Oud, Johan; Ghidey, Wendimagegn

2014-01-01

This book describes various ways of approaching and interpreting the data produced by clinical trial studies, with a special emphasis on the essential role that biostatistics plays in clinical trials. Over the past few decades the role of statistics in the evaluation and interpretation of clinical data has become of paramount importance. As a result the standards of clinical study design, conduct and interpretation have undergone substantial improvement. The book includes 18 carefully reviewed chapters on recent developments in clinical trials and their statistical evaluation, with each chapter providing one or more examples involving typical data sets, enabling readers to apply the proposed procedures. The chapters employ a uniform style to enhance comparability between the approaches.

Effects of a Community-Based, Post-Rehabilitation Exercise Program in COPD: Protocol for a Randomized Controlled Trial With Embedded Process Evaluation.

Science.gov (United States)

Desveaux, Laura; Beauchamp, Marla K; Lee, Annemarie; Ivers, Noah; Goldstein, Roger; Brooks, Dina

2016-05-11

This manuscript (1) outlines the intervention, (2) describes how its effectiveness is being evaluated in a pragmatic randomized controlled trial, and (3) summarizes the embedded process evaluation aiming to understand key barriers and facilitators for implementation in new environments. Participating centers refer eligible individuals with COPD following discharge from their local PR program. Consenting patients are assigned to a year-long community exercise program or usual care using block randomization and stratifying for supplemental oxygen use. Patients in the intervention arm are asked to attend an exercise session at least twice per week at their local community facility where their progress is supervised by a case manager. Each exercise session includes a component of aerobic exercise, and activities designed to optimize balance, flexibility, and strength. All study participants will have access to routine follow-up appointments with their respiratory physician, and additional health care providers as part of their usual care. Assessments will be completed at baseline (post-PR), 6, and 12 months, and include measures of functional exercise capacity, quality of life, self-efficacy, and health care usage. Intervention effectiveness will be assessed by comparing functional exercise capacity between intervention and control groups. A mixed-methods process evaluation will be conducted to better understand intervention implementation, guided by Normalization Process Theory and the Consolidated Framework for Implementation Research. Based on results from our pilot work, we anticipate a maintenance of exercise capacity and improved health-related quality of life in the intervention group, compared with a decline in exercise capacity in the usual care group. Findings from this study will improve our understanding of the effectiveness of community-based exercise programs for maintaining benefits following PR in patients with COPD and provide information on how best

Ear Acupuncture for Post-Operative Pain Associated with Ambulatory Arthroscopic Knee Surgery: A Randomized Controlled Trial

Science.gov (United States)

2014-01-14

E7(/(3+21(180%(5 ,QFOXGHDUHDFRGH 14 Jan 2014 Final Report Ear acupuncture for post-operative pain associated with ambulatory arthroscopic...DISTRIBUTION A. Approved for public release: distribution unlimited. The purpose of this study is to compare ear acupuncture plus standard therapy versus...3298 Ear Acupuncture for Post-operative Pa111 Assoc1ated With Ambulatory Arthroscopic Knee Surgery A Randomized Controlled Trial ’• V ’’ ’-’ I

Constraint-Induced Aphasia Therapy for Treatment of Chronic Post-Stroke Aphasia: A Randomized, Blinded, Controlled Pilot Trial.

Science.gov (United States)

Szaflarski, Jerzy P; Ball, Angel L; Vannest, Jennifer; Dietz, Aimee R; Allendorfer, Jane B; Martin, Amber N; Hart, Kimberly; Lindsell, Christopher J

2015-09-24

To provide a preliminary estimate of efficacy of constraint-induced aphasia therapy (CIAT) when compared to no-intervention in patients with chronic (>1 year) post-stroke aphasia in order to plan an appropriately powered randomized controlled trial (RCT). We conducted a pilot single-blinded RCT. 24 patients were randomized: 14 to CIAT and 10 to no-intervention. CIAT groups received up to 4 hours/day of intervention for 10 consecutive business days (40 hours or therapy). Outcomes were assessed within 1 week of intervention and at 1 and 12 weeks after intervention and included several linguistic measures and a measure of overall subjective communication abilities (mini-Communicative Abilities Log (mini-CAL)). Clinicians treating patients (CIAT group) did not communicate with other team members to maintain blinding and the testing team members were blinded to treatment group assignment. Overall, the results of this pilot RCT support the results of previous observational studies that CIAT may lead to improvements in linguistic abilities. At 12 weeks, the treatment group reported better subjective communication abilities (mini-CAL) than the no-intervention group (p=0.019). Other measures trended towards better performance in the CIAT group. In this pilot RCT intensive language therapy led to an improvement in subjective language abilities. The effects demonstrated allow the design of a definitive trial of CIAT in patients with a variety of post-stroke aphasia types. In addition, our experiences have identified important considerations for designing subsequent trial(s) of CIAT or other interventions for post-stroke aphasia.

Fluid hydration to prevent post-ERCP pancreatitis in average- to high-risk patients receiving prophylactic rectal NSAIDs (FLUYT trial): study protocol for a randomized controlled trial.

Science.gov (United States)

Smeets, Xavier J N M; da Costa, David W; Fockens, Paul; Mulder, Chris J J; Timmer, Robin; Kievit, Wietske; Zegers, Marieke; Bruno, Marco J; Besselink, Marc G H; Vleggaar, Frank P; van der Hulst, Rene W M; Poen, Alexander C; Heine, Gerbrand D N; Venneman, Niels G; Kolkman, Jeroen J; Baak, Lubbertus C; Römkens, Tessa E H; van Dijk, Sven M; Hallensleben, Nora D L; van de Vrie, Wim; Seerden, Tom C J; Tan, Adriaan C I T L; Voorburg, Annet M C J; Poley, Jan-Werner; Witteman, Ben J; Bhalla, Abha; Hadithi, Muhammed; Thijs, Willem J; Schwartz, Matthijs P; Vrolijk, Jan Maarten; Verdonk, Robert C; van Delft, Foke; Keulemans, Yolande; van Goor, Harry; Drenth, Joost P H; van Geenen, Erwin J M

2018-04-02

Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most common complication of ERCP and may run a severe course. Evidence suggests that vigorous periprocedural hydration can prevent PEP, but studies to date have significant methodological drawbacks. Importantly, evidence for its added value in patients already receiving prophylactic rectal non-steroidal anti-inflammatory drugs (NSAIDs) is lacking and the cost-effectiveness of the approach has not been investigated. We hypothesize that combination therapy of rectal NSAIDs and periprocedural hydration would significantly lower the incidence of post-ERCP pancreatitis compared to rectal NSAIDs alone in moderate- to high-risk patients undergoing ERCP. The FLUYT trial is a multicenter, parallel group, open label, superiority randomized controlled trial. A total of 826 moderate- to high-risk patients undergoing ERCP that receive prophylactic rectal NSAIDs will be randomized to a control group (no fluids or normal saline with a maximum of 1.5 mL/kg/h and 3 L/24 h) or intervention group (lactated Ringer's solution with 20 mL/kg over 60 min at start of ERCP, followed by 3 mL/kg/h for 8 h thereafter). The primary endpoint is the incidence of post-ERCP pancreatitis. Secondary endpoints include PEP severity, hydration-related complications, and cost-effectiveness. The FLUYT trial design, including hydration schedule, fluid type, and sample size, maximize its power of identifying a potential difference in post-ERCP pancreatitis incidence in patients receiving prophylactic rectal NSAIDs. EudraCT: 2015-000829-37 . Registered on 18 February 2015. 13659155 . Registered on 18 May 2015.

Evidence-based intervention against bullying and cyberbullying: Evaluation of the NoTrap! program in two independent trials.

Science.gov (United States)

Palladino, Benedetta E; Nocentini, Annalaura; Menesini, Ersilia

2016-01-01

The NoTrap! (Noncadiamointrappola!) program is a school-based intervention, which utilizes a peer-led approach to prevent and combat both traditional bullying and cyberbullying. The aim of the present study was to evaluate the efficacy of the third Edition of the program in accordance with the recent criteria for evidence-based interventions. Towards this aim, two quasi-experimental trials involving adolescents (age M = 14.91, SD = .98) attending their first year at different high schools were conducted. In Trial 1 (control group, n = 171; experimental group, n = 451), latent growth curve models for data from pre-, middle- and post-tests showed that intervention significantly predicted change over time in all the target variables (victimization, bullying, cybervictimization, and cyberbullying). Specifically, target variables were stable for the control group but decreased significantly over time for the experimental group. Long-term effects at the follow up 6 months later were also found. In Trial 2 (control group, n = 227; experimental group, n = 234), the moderating effect of gender was examined and there was a reported decrease in bullying and cyberbullying over time (pre- and post-test) in the experimental group but not the control group, and this decrease was similar for boys and girls. © 2016 Wiley Periodicals, Inc.

Effectiveness evaluation of whole-body electromyostimulation as a post-exercise recovery method.

Science.gov (United States)

DE LA Camara, Miguel A; Pardos, Ana I; Veiga, Óscar L

2018-01-04

Whole-body electromyostimulation (WB-EMS) devices are now being used in health and sports training, although there are few studies investigating their benefits. The objective of this research was to evaluate the effectiveness of WB-EMS as a post-exercise recovery method, and compare it with other methods like active and passive recovery. The study included nine trained men (age = 21 ± 1years, height = 1.77 ± 0.4 m, mass = 62 ± 7 kg). Three trials were performed in three different sessions, 1 week apart. Each trial, the participants completed the same exercise protocol and a different recovery method each time. A repeated measures design was used to check the basal reestablishing on several physiological variables [lactate, heart rate, percentage of tissue hemoglobin saturation, temperature, and neuromuscular fatigue] and to evaluate the quality of recovery. The non-parametric Wilcoxon and Friedman ANOVA tests were used to examine the differences between recovery methods. The results showed no differences between methods in the physiological and psychological variables analyzed. Although, the blood lactate concentration showed borderline statistical significance between methods (P = 0.050). Likewise, WB-EMS failed to recover baseline blood lactate concentration (P = 0.021) and percentage of tissue hemoglobin saturation (P = 0.023), in contrast to the other two methods. These findings suggest that WB-EMS is not a good recovery method because the power of reestablishing of several physiological and psychological parameters is not superior to other recovery methods like active and passive recovery.

Effects of acupuncture and computer-assisted cognitive training for post-stroke attention deficits: study protocol for a randomized controlled trial.

Science.gov (United States)

Huang, Jia; McCaskey, Michael A; Yang, Shanli; Ye, Haicheng; Tao, Jing; Jiang, Cai; Schuster-Amft, Corina; Balzer, Christian; Ettlin, Thierry; Schupp, Wilfried; Kulke, Hartwig; Chen, Lidian

2015-12-02

A majority of stroke survivors present with cognitive impairments. Attention disturbance, which leads to impaired concentration and overall reduced cognitive functions, is strongly associated with stroke. The clinical efficacy of acupuncture with Baihui (GV20) and Shenting (GV24) as well as computer-assisted cognitive training in stroke and post-stroke cognitive impairment have both been demonstrated in previous studies. To date, no systematic comparison of these exists and the potential beneficial effects of a combined application are yet to be examined. The main objective of this pilot study is to evaluate the effects of computer-assisted cognitive training compared to acupuncture on the outcomes of attention assessments. The second objective is to test the effects of a combined cognitive intervention that incorporates computer-assisted cognitive training and acupuncture (ACoTrain). An international multicentre, single-blinded, randomised controlled pilot trial will be conducted. In a 1:1:1 ratio, 60 inpatients with post-stroke cognitive dysfunction will be randomly allocated into either the acupuncture group, the computer-assisted cognitive training group, or the ACoTrain group in addition to their individual rehabilitation programme. The intervention period of this pilot trial will last 4 weeks (30 minutes per day, 5 days per week, Monday to Friday). The primary outcome is the test battery for attentional performance. The secondary outcomes include the Trail Making Test, Test des Deux Barrages, National Institute of Health Stroke Scale, and Modified Barthel Index for assessment of daily life competence, and the EuroQol Questionnaire for health-related quality of life. This trial mainly focuses on evaluating the effects of computer-assisted cognitive training compared to acupuncture on the outcomes of attention assessments. The results of this pilot trial are expected to provide new insights on how Eastern and Western medicine can complement one another and

Cross-system evaluation of clinical trial search engines.

Science.gov (United States)

Jiang, Silis Y; Weng, Chunhua

2014-01-01

Clinical trials are fundamental to the advancement of medicine but constantly face recruitment difficulties. Various clinical trial search engines have been designed to help health consumers identify trials for which they may be eligible. Unfortunately, knowledge of the usefulness and usability of their designs remains scarce. In this study, we used mixed methods, including time-motion analysis, think-aloud protocol, and survey, to evaluate five popular clinical trial search engines with 11 users. Differences in user preferences and time spent on each system were observed and correlated with user characteristics. In general, searching for applicable trials using these systems is a cognitively demanding task. Our results show that user perceptions of these systems are multifactorial. The survey indicated eTACTS being the generally preferred system, but this finding did not persist among all mixed methods. This study confirms the value of mixed-methods for a comprehensive system evaluation. Future system designers must be aware that different users groups expect different functionalities.

A randomized trial of rectal indomethacin and sublingual nitrates to prevent post-ERCP pancreatitis.

Science.gov (United States)

Sotoudehmanesh, Rasoul; Eloubeidi, Mohamad Ali; Asgari, Ali Ali; Farsinejad, Maryam; Khatibian, Morteza

2014-06-01

Acute pancreatitis is the most common adverse event of endoscopic retrograde cholangiopancreatography (ERCP). Recent data suggest that indomethacin can reduce the risk of post-ERCP pancreatitis (PEP) in high-risk individuals. However, whether the combination of indomethacin and sublingual nitrates is superior to indomethacin alone is unknown. Therefore, we aimed to evaluate the efficacy of rectally administered indomethacin plus sublingual nitrate compared with indomethacin alone to prevent PEP. During a 17-month period, all eligible patients who underwent ERCP were enrolled in this study. We excluded patients who had undergone a prior endoscopic sphincterotomy. In a double-blind controlled randomized trial, patients received a suppository containing 100 mg of indomethacin, plus 5 mg of sublingual nitrate (group A), or a suppository containing 100 mg of indomethacin, plus sublingual placebo (group B), before ERCP. Serum amylase levels and clinically pertinent evaluations were measured in all patients after ERCP. Of the 300 enrolled patients, 150 received indomethacin plus nitrate. Thirty-three patients developed pancreatitis: 10 (6.7%) in group A and 23 (15.3%) in group B (P=0.016, risk ratio=0.39, 95% confidence intervals (CI): 0.18-0.86). More than 80% of the patients were at high risk of developing pancreatitis after ERCP. Absolute risk reduction, relative risk reduction, and number needed to treat for the prevention of PEP were 8.6% (95% CI: 4.7-14.5), 56.2% (95% CI: 50.6-60.8), and 12 (95% CI: 7-22), respectively. Combination of rectal indomethacin and sublingual nitrate given before ERCP was significantly more likely to reduce the incidence of PEP than indomethacin suppository alone. Multicenter trials to confirm these promising findings are needed.

A randomized controlled trial of brief Somatic Experiencing for chronic low back pain and comorbid post-traumatic stress disorder symptoms

DEFF Research Database (Denmark)

Andersen, Tonny Elmose; Lahav, Yael; Ellegaard, Hanne

2017-01-01

Background: It is well documented that comorbid post-traumatic stress disorder (PTSD) in chronic pain is associated with a more severe symptom profile with respect to pain, disability and psychological distress. However, very few intervention studies exist targeting both PTSD and pain. The current...... study is the first randomized controlled trial evaluating the effect of the body-oriented trauma approach of Somatic Experiencing (SE) for comorbid PTSD and low back pain. Although the method is well recognized by clinicians and widely used, SE still needs to be tested in a randomized clinical trial...... in comparison with an active control group. Objective: The aim of the current study was to compare the effect of an SE intervention in addition to treatment-as-usual (TAU) for patients with chronic low back pain and comorbid PTSD compared to TAU alone. Method: The study was a two-group randomized controlled...

Twelve month follow-up on a randomised controlled trial of relaxation training for post-stroke anxiety.

Science.gov (United States)

Golding, Katherine; Fife-Schaw, Chris; Kneebone, Ian

2017-09-01

To follow up participants in a randomised controlled trial of relaxation training for anxiety after stroke at 12 months. Twelve month follow-up to a randomised controlled trial, in which the control group also received treatment. Community. Fifteen of twenty one original participants with post-stroke anxiety participated in a one year follow-up study. A self-help autogenic relaxation CD listened to five times a week for one month, immediately in the intervention group and after three months in the control group. Hospital Anxiety and Depression Scale-Anxiety subscale and the Telephone Interview of Cognitive Status for inclusion. Hospital Anxiety and Depression Scale-Anxiety subscale for outcome. All measures were administered by phone. Anxiety ratings reduced significantly between pre and post-intervention, and between pre-intervention and one year follow-up ( χ 2 (2) = 22.29, p autogenic relaxation CD appear to be maintained after one year.

The POST trial: initial post-market experience of the Penumbra system: revascularization of large vessel occlusion in acute ischemic stroke in the United States and Europe.

Science.gov (United States)

Tarr, Robert; Hsu, Dan; Kulcsar, Zsolt; Bonvin, Christophe; Rufenacht, Daniel; Alfke, Karsten; Stingele, Robert; Jansen, Olav; Frei, Donald; Bellon, Richard; Madison, Michael; Struffert, Tobias; Dorfler, Arnd; Grunwald, Iris Q; Reith, Wolfgang; Haass, Anton

2010-12-01

The purpose of this study was to assess the initial post-market experience of the device and how it is compared with the Penumbra Pivotal trial used to support the 510k application. A retrospective case review of 157 consecutive patients treated with the Penumbra system at seven international centers was performed. Primary endpoints were revascularization of the target vessel (TIMI score of 2 or 3), good functional outcome as defined by a modified Rankin scale (mRS) score of ≤2 and incidence of procedural serious adverse events. Results were compared with those of the Penumbra pivotal trial. A total of 157 vessels were treated. Mean baseline values at enrollment were: age 65 years, NIHSS score 16. After use of the Penumbra system, 87% of the treated vessels were revascularized to TIMI 2 (54%) or 3 (33%) as compared with 82% reported in the Pivotal trial. Nine procedural serious adverse events were reported in 157 patients (5.7%). All-cause mortality was 20% (32/157), and 41% had a mRS of ≤2 at 90-day follow-up as compared with only 25% in the Pivotal trial. Patients who were successfully revascularized by the Penumbra system had significantly better outcomes than those who were not. Initial post-market experience of the Penumbra system revealed that the revascularization rate and safety profile of the device are comparable to those reported in the Pivotal trial. However, the proportion of patients who had good functional outcome was higher than expected.

Post-Occupancy Evaluation of Facilities Change

NARCIS (Netherlands)

van der Voordt, Theo; de Been, I.; Maarleveld, M.; Finch, E

2012-01-01

This chapter discusses possible aims, tools and deliverables of Post-Occupancy Evaluations (POE) (otherwise known as building-in-use studies), with a focus on interventions in supporting facilities. POE has a long tradition and has been applied in different fields (e.g. offices, educational

How to Evaluate Phase Differences between Trial Groups in Ongoing Electrophysiological Signals

Science.gov (United States)

VanRullen, Rufin

2016-01-01

A growing number of studies endeavor to reveal periodicities in sensory and cognitive functions, by comparing the distribution of ongoing (pre-stimulus) oscillatory phases between two (or more) trial groups reflecting distinct experimental outcomes. A systematic relation between the phase of spontaneous electrophysiological signals, before a stimulus is even presented, and the eventual result of sensory or cognitive processing for that stimulus, would be indicative of an intrinsic periodicity in the underlying neural process. Prior studies of phase-dependent perception have used a variety of analytical methods to measure and evaluate phase differences, and there is currently no established standard practice in this field. The present report intends to remediate this need, by systematically comparing the statistical power of various measures of “phase opposition” between two trial groups, in a number of real and simulated experimental situations. Seven measures were evaluated: one parametric test (circular Watson-Williams test), and three distinct measures of phase opposition (phase bifurcation index, phase opposition sum, and phase opposition product) combined with two procedures for non-parametric statistical testing (permutation, or a combination of z-score and permutation). While these are obviously not the only existing or conceivable measures, they have all been used in recent studies. All tested methods performed adequately on a previously published dataset (Busch et al., 2009). On a variety of artificially constructed datasets, no single measure was found to surpass all others, but instead the suitability of each measure was contingent on several experimental factors: the time, frequency, and depth of oscillatory phase modulation; the absolute and relative amplitudes of post-stimulus event-related potentials for the two trial groups; the absolute and relative trial numbers for the two groups; and the number of permutations used for non-parametric testing

Timely and complete publication of economic evaluations alongside randomized controlled trials.

Science.gov (United States)

Thorn, Joanna C; Noble, Sian M; Hollingworth, William

2013-01-01

Little is known about the extent and nature of publication bias in economic evaluations. Our objective was to determine whether economic evaluations are subject to publication bias by considering whether economic data are as likely to be reported, and reported as promptly, as effectiveness data. Trials that intended to conduct an economic analysis and ended before 2008 were identified in the International Standard Randomised Controlled Trial Number (ISRCTN) register; a random sample of 100 trials was retrieved. Fifty comparator trials were randomly drawn from those not identified as intending to conduct an economic study. The trial start and end dates, estimated sample size and funder type were extracted. For trials planning economic evaluations, effectiveness and economic publications were sought; publication dates and journal impact factors were extracted. Effectiveness abstracts were assessed for whether they reached a firm conclusion that one intervention was most effective. Primary investigators were contacted about reasons for non-publication of results, or reasons for differential publication strategies for effectiveness and economic results. Trials planning an economic study were more likely to be funded by government (p = 0.01) and larger (p = 0.003) than other trials. The trials planning an economic evaluation had a mean of 6.5 (range 2.7-13.2) years since the trial end in which to publish their results. Effectiveness results were reported by 70 %, while only 43 % published economic evaluations (p economic results included the intervention being ineffective, and staffing issues. Funding source, time since trial end and length of study were not associated with a higher probability of publishing the economic evaluation. However, studies that were small or of unknown size were significantly less likely to publish economic evaluations than large studies (p journal impact factor was 1.6 points higher for effectiveness publications than for the

Pre-liver transplant psychosocial evaluation predicts post-transplantation outcomes.

Science.gov (United States)

Benson, Ariel A; Rowe, Mina; Eid, Ahmad; Bluth, Keren; Merhav, Hadar; Khalaileh, Abed; Safadi, Rifaat

2018-08-01

Psychosocial factors greatly impact the course of patients throughout the liver transplantation process. A retrospective chart review was performed of patients who underwent liver transplantation at Hadassah-Hebrew University Medical Center between 2002 and 2012. A composite psychosocial score was computed based on the patient's pre-transplant evaluation. Patients were divided into two groups based on compliance, support and insight: Optimal psychosocial score and Non-optimal psychosocial score. Post-liver transplantation survival and complication rates were evaluated. Out of 100 patients who underwent liver transplantation at the Hadassah-Hebrew University Medical Center between 2002 and 2012, 93% had a complete pre-liver transplant psychosocial evaluation in the medical record performed by professional psychologists and social workers. Post-liver transplantation survival was significantly higher in the Optimal group (85%) as compared to the Non-optimal group (56%, p = .002). Post-liver transplantation rate of renal failure was significantly lower in the Optimal group. No significant differences were observed between the groups in other post-transplant complications. A patient's psychosocial status may impact outcomes following transplantation as inferior psychosocial grades were associated with lower overall survival and increased rates of complications. Pre-liver transplant psychosocial evaluations are an important tool to help predict survival following transplantation.

Evaluation Using Sequential Trials Methods.

Science.gov (United States)

Cohen, Mark E.; Ralls, Stephen A.

1986-01-01

Although dental school faculty as well as practitioners are interested in evaluating products and procedures used in clinical practice, research design and statistical analysis can sometimes pose problems. Sequential trials methods provide an analytical structure that is both easy to use and statistically valid. (Author/MLW)

[In vivo evaluation of carbon fiber posts].

Science.gov (United States)

Lai, V; Lugliè, P F; Chessa, G

2002-05-01

The use of carbon fiber posts allows morpho-functional restoration of endodontically treated teeth with an assembly of materials of a modulus of elasticity similar to that of dentin. The study clinically evaluated the percentage of survival of dental elements treated and reconstructed with endocanal carbon fiber posts. At the Dentistry Clinic of the University of Sassari 60 dental elements were selected from 46 subjects. The teeth, which had been treated endodontically with success for at least six months, were classified by parameters taken from the international literature and reconstructed using Tech 2000 carbon fiber posts and adhesive resinous systems recommended by the post manufacturer. The success rate was 98.4%. Almost half (49%) of the samples were single-rooted elements, 37.4% of the posts were 1.2 mm in diameter; in 78.3% the opposing contact was with a natural tooth; 100% of the elements had a type A dental structure. Third generation posts are a valid alternative to metallic posts and improve the prognosis of the treated element. The carbon fiber posts fixed with the composite, forming a single unit with the dental element, thus improving mid-term RESULTS. The technique is easy to use under clinical conditions and can be performed in a single session. So far, the method has provided promising clinical results, as this study demonstrated.

Trial 1 versus Trial 2 of the Test of Memory Malingering: Evaluating accuracy without a "gold standard".

Science.gov (United States)

Mossman, Douglas; Wygant, Dustin B; Gervais, Roger O; Hart, Kathleen J

2018-01-01

This study examines the accuracy of the Test of Memory Malingering (TOMM), a frequently administered measure for evaluating effort during neurocognitive testing. In the last few years, several authors have suggested that the initial recognition trial of the TOMM (Trial 1) might be a more useful index for detecting feigned or exaggerated impairment than Trial 2, which is the source for inference recommended by the original instruction manual (Tombaugh, 1996). We used latent class modeling (LCM) implemented in a Bayesian framework to evaluate archival Trial 1 and Trial 2 data collected from 1,198 adults who had undergone outpatient forensic evaluations. All subjects were tested with 2 other performance validity tests (the Word Memory Test and the Computerized Assessment of Response Bias), and for 70% of the subjects, data from the California Verbal Learning Test-Second Edition Forced Choice trial were also available. Our results suggest that not even a perfect score on Trial 1 or Trial 2 justifies saying that an evaluee is definitely responding genuinely, although such scores imply a lower-than-base-rate probability of feigning. If one uses a Trial 2 cut-off higher than the manual's recommendation, Trial 2 does better than Trial 1 at identifying individuals who are almost certainly feigning while maintaining a negligible false positive rate. Using scores from both trials, one can identify a group of definitely feigning and very likely feigning subjects who comprise about 2 thirds of all feigners; only 1% of the members of this group would not be feigning. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial: Post-Intervention Results

Science.gov (United States)

Fitzgibbon, M. L.; Stolley, M. R.; Schiffer, L.; Braunschweig, C. L.; Gomez, S. L.; Van Horn, L.; Dyer, A.

2013-01-01

The preschool years offer an opportunity to interrupt the trajectory toward obesity in black children. The Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial was a group-randomized controlled trial assessing the feasibility and effectiveness of a teacher-delivered weight control intervention for black preschool children. The 618 participating children were enrolled in 18 schools administered by the Chicago Public Schools. Children enrolled in the 9 schools randomized to the intervention group received a 14-week weight control intervention delivered by their classroom teachers. Children in the 9 control schools received a general health intervention. Height and weight, physical activity, screen time, and diet data were collected at baseline and post-intervention. At post-intervention, children in the intervention schools engaged in more moderate-to vigorous physical activity than children in the control schools (difference between adjusted group means=7.46 min/day, p=.02). Also, children in the intervention group had less total screen time (−27.8 min/day, p=.05). There were no significant differences in BMI, BMI Z score, or dietary intake. It is feasible to adapt an obesity prevention program to be taught by classroom teachers. The intervention showed positive influences on physical activity and screen time, but not diet. Measuring diet and physical activity in preschool children remains a challenge, and interventions delivered by classroom teachers require both intensive initial training and ongoing individualized supervision. PMID:21193852

Systematic Evaluation of Promising Clinical Trials-Gene Silencing for the Treatment of Glioblastoma.

Science.gov (United States)

Karaarslan, Numan; Yilmaz, Ibrahim; Ozbek, Hanefi; Caliskan, Tezcan; Topuk, Savas; Sirin, Duygu Yasar; Ates, Ozkan

2018-04-06

The aim of this study was to systematically investigate the role of artificial small interfering RNA (siRNA) molecules in glioblastoma treatment and to give a detailed overview of the literature concerning studies performed in this field worldwide in the last 31 years. Articles about clinical trials conducted between December 1, 1949 and November 8, 2017, were identified from the Cochrane Collaboration, the Cochrane Library, Ovid MEDLINE, ProQuest, the National Library of Medicine, and PubMed electronic databases, using the terms "post transcriptional gene silencing," "small interfering RNA," "siRNA," and "glioblastoma," either individually or combined (\\"OR\\" and \\"AND"), without language and country restrictions. Articles that met the examination criteria were included in the study. After descriptive statistical evaluation, the results were reported in frequency (%). After scanning 2.752 articles, five articles were found that met the research criteria. Examination of full texts of the five identified articles provided no sufficient evidence for research conducted with regard to the use of gene silencing via siRNAs in glioblastoma treatment. To be able to evaluate the clinical use of siRNAs, there is an urgent need for in-vivo studies and for trials with randomized, controlled, and clinical designs that provide long-term functional outcomes.

Post-caesarean analgesia: What is new?

Directory of Open Access Journals (Sweden)

Sukhyanti Kerai

2017-01-01

Full Text Available Adequate post-operative analgesia after caesarean section (CS is vital as it impacts the distinct surgical recovery requirements of the parturient. Although newer analgesic modalities and drugs for post-caesarean analgesia have been introduced over the recent years, review of the literature suggests suggests that we are far from achieving the goals of optimum post-operative analgesia. We conducted a systematic review of recent advances in modalities for post-caesarean analgesia. After systematic search and quality assessment of studies, we included a total of 51 randomised controlled trials that evaluated the role of opioids, transversus abdominis plane (TAP block, wound infiltration/infusion, ketamine, gabapentin and ilioinguinal-iliohypogastric nerve block (II-IH NB for post-caesarean analgesia. Administration of opioids still remains the gold standard for post-operative analgesia, but the associated troublesome side effects have led to the mandatory incorporation of non-opioid analgesics in post-CS analgesia regime. Among the non-opioid techniques, TAP block is the most investigated modality of the last decade. The analgesic efficacy of TAP block as a part of multimodal analgesia is established in post-CS cases where intrathecal morphine is not employed and in CS under general anaesthesia. Among non-steroidal anti-inflammatory drugs, COX-I inhibitors and intravenous paracetamol are found to be useful in post-operative analgesic regimen. The perioperative use of ketamine is found useful only in CS done under spinal anaesthesia; no benefit is seen where general anaesthesia is employed. Wound infiltration with local anaesthetics, systemic gabapentin and II-IH NB need further trials to assess their efficacy.

Neuroimaging Correlates of Post-Stroke Aphasia Rehabilitation in a Pilot Randomized Trial of Constraint-Induced Aphasia Therapy.

Science.gov (United States)

Nenert, Rodolphe; Allendorfer, Jane B; Martin, Amber M; Banks, Christi; Ball, Angel; Vannest, Jennifer; Dietz, Aimee R; Szaflarski, Jerzy P

2017-07-18

BACKGROUND Recovery from post-stroke aphasia is a long and complex process with an uncertain outcome. Various interventions have been proposed to augment the recovery, including constraint-induced aphasia therapy (CIAT). CIAT has been applied to patients suffering from post-stroke aphasia in several unblinded studies to show mild-to-moderate linguistic gains. The aim of the present study was to evaluate the neuroimaging correlates of CIAT in patients with chronic aphasia related to left middle cerebral artery stroke. MATERIAL AND METHODS Out of 24 patients recruited in a pilot randomized blinded trial of CIAT, 19 patients received fMRI of language. Eleven of them received CIAT (trained) and eight served as a control group (untrained). Each patient participated in three fMRI sessions (before training, after training, and 3 months later) that included semantic decision and verb generation fMRI tasks, and a battery of language tests. Matching healthy control participants were also included (N=38; matching based on age, handedness, and sex). RESULTS Language testing showed significantly improved performance on Boston Naming Test (BNT; paphasia with no specific effect from CIAT training.

Efficacy of interpersonal therapy-group format adapted to post-traumatic stress disorder: an open-label add-on trial.

Science.gov (United States)

Campanini, Rosaly F B; Schoedl, Aline F; Pupo, Mariana C; Costa, Ana Clara H; Krupnick, Janice L; Mello, Marcelo F

2010-01-01

Post-traumatic stress disorder (PTSD) is a highly prevalent condition, yet available treatments demonstrate only modest efficacy. Exposure therapies, considered by many to be the "gold-standard" therapy for PTSD, are poorly tolerated by many patients and show high attrition. We evaluated interpersonal therapy, in a group format, adapted to PTSD (IPT-G PTSD), as an adjunctive treatment for patients who failed to respond to conventional psychopharmacological treatment. Research participants included 40 patients who sought treatment through a program on violence in the department of psychiatry of Federal University of São Paulo (UNIFESP). They had received conventional psychopharmacological treatment for at least 12 weeks and failed to have an adequate clinical response. After signing an informed consent, approved earlier by the UNIFESP Ethics Review Board, they received a semi-structured diagnostic interview (SCID-I), administered by a trained mental health worker, to confirm the presence of a PTSD diagnosis according to DSM-IV criteria. Other instruments were administered, and patients completed out self-report instruments at baseline, and endpoint to evaluate clinical outcomes. Thirty-three patients completed the trial, but all had at least one second outcome evaluation. There were significant improvements on all measures, with large effect sizes. IPT-G PTSD was effective not only in decreasing symptoms of PTSD, but also in decreasing symptoms of anxiety and depression. It led to significant improvements in social adjustment and quality of life. It was well tolerated and there were few dropouts. Our results are very preliminary; they need further confirmation through randomized controlled clinical trials.

Design Alternative Evaluation No. 3: Post-Closure Ventilation

International Nuclear Information System (INIS)

Logan, R.C.

1999-01-01

The objective of this study is to provide input to the Enhanced Design Alternatives (EDA) for License Application Design Selection (LADS). Its purpose is to develop and evaluate conceptual designs for post-closure ventilation alternatives that enhance repository performance. Post-closure ventilation is expected to enhance repository performance by limiting the amount of water contacting the waste packages. Limiting the amount of water contacting the waste packages will reduce corrosion

Does participating in a clinical trial affect subsequent nursing management? Post-trial care for participants recruited to the INTACT pressure ulcer prevention trial: A follow-up study.

Science.gov (United States)

Webster, Joan; Bucknall, Tracey; Wallis, Marianne; McInnes, Elizabeth; Roberts, Shelley; Chaboyer, Wendy

2017-06-01

Participation in a clinical trial is believed to benefit patients but little is known about the post-trial effects on routine hospital-based care. To describe (1) hospital-based, pressure ulcer care-processes after patients were discharged from a pressure ulcer prevention, cluster randomised controlled trial; and (2) to investigate if the trial intervention had any impact on subsequent hospital-based care. We conducted a retrospective analysis of 133 trial participants who developed a pressure ulcer during the clinical trial. We compared outcomes and care processes between participants who received the pressure ulcer prevention intervention and those in the usual care, control group. We also compared care processes according to the pressure ulcer stage. A repositioning schedule was reported for 19 (14.3%) patients; 33 (24.8%) had a dressing applied to the pressure ulcer; 17 (12.8) patients were assessed by a wound care team; and 20 (15.0%) were seen by an occupational therapist. Patients in the trial's intervention group were more likely to have the presence of a pressure ulcer documented in their chart (odds ratio (OR) 8.18, 95% confidence intervals (CI) 3.64-18.36); to be referred to an occupational therapist OR 0.92 (95% CI 0.07; 0.54); to receive a pressure relieving device OR 0.31 (95% CI 0.14; 0.69); or a pressure relieving mattress OR 0.44 (95% CI 0.20; 0.96). Participants with Stage 2 or unstageable ulcers were more likely than others to have dressings applied to their wounds (p=pressure ulcer status and care is poor. Copyright © 2017 Elsevier Ltd. All rights reserved.

Does glyceryl nitrate prevent post-ERCP pancreatitis? A prospective, randomized, double-blind, placebo-controlled multicenter trial

DEFF Research Database (Denmark)

Nøjgaard, Camilla; Hornum, Mads; Elkjaer, Margarita

2009-01-01

OBJECTIVE: Acute pancreatitis is the most dreaded complication of ERCP. Two studies have shown a significant effect of glyceryl nitrate (GN) in preventing post-ERCP pancreatitis (PEP). We wanted to evaluate this promising effect in a larger study with a realistically precalculated incidence of PEP...... (PL) was an identical-looking patch applied before ERCP. A total of 401 patients received GN; 405 received PL. RESULTS: Forty-seven patients had PEP (5.8%), 18 (4.5%) in the GN group and 29 (7.1%) in the PL group. The relative risk reduction of PEP in the GN group of 36% (95% CI, 11%-65%) compared...... (P = .006) were more common in the GN group. Significant variables predictive of PEP were not having biliary stones extracted; hypotension after ERCP; morphine, propofol, glucagon, and general anesthesia during the procedure; or no sufentanil during the procedure. CONCLUSIONS: The trial showed...

Reducing child abuse amongst adolescents in low- and middle-income countries: A pre-post trial in South Africa.

Science.gov (United States)

Cluver, Lucie; Meinck, Franziska; Yakubovich, Alexa; Doubt, Jenny; Redfern, Alice; Ward, Catherine; Salah, Nasteha; De Stone, Sachin; Petersen, Tshiamo; Mpimpilashe, Phelisa; Romero, Rocio Herrero; Ncobo, Lulu; Lachman, Jamie; Tsoanyane, Sibongile; Shenderovich, Yulia; Loening, Heidi; Byrne, Jasmina; Sherr, Lorraine; Kaplan, Lauren; Gardner, Frances

2016-07-13

No known studies have tested the effectiveness of child abuse prevention programmes for adolescents in low- or middle-income countries. 'Parenting for Lifelong Health' ( http://tiny.cc/whoPLH ) is a collaborative project to develop and rigorously test abuse-prevention parenting programmes for free use in low-resource contexts. Research aims of this first pre-post trial in South Africa were: i) to identify indicative effects of the programme on child abuse and related outcomes; ii) to investigate programme safety for testing in a future randomised trial, and iii) to identify potential adaptations. Two hundred thirty participants (adolescents and their primary caregivers) were recruited from schools, welfare services and community-sampling in rural, high-poverty South Africa (no exclusion criteria). All participated in a 12-week parenting programme, implemented by local NGO childcare workers to ensure real-world external validity. Standardised pre-post measures with adolescents and caregivers were used, and paired t-tests were conducted for primary outcomes: abuse (physical, emotional abuse and neglect), adolescent behaviour problems and parenting (positive and involved parenting, poor monitoring and inconsistent discipline), and secondary outcomes: mental health, social support and substance use. Participants reported high levels of socio-economic deprivation, e.g. 60 % of adolescents had either an HIV-positive caregiver or were orphaned by AIDS, and 50 % of caregivers experienced intimate partner violence. i) indicative effects: Primary outcomes comparing pre-test and post-test assessments showed reductions reported by adolescents and caregivers in child abuse (adolescent report 63.0 % pre-test to 29.5 % post-test, caregiver report 75.5 % pre-test to 36.5 % post-test, both p child abuse and improved caregiver and adolescent outcomes. It showed high acceptability and unexpected community-level diffusion. Findings indicate needs for adaptations, and

[Systematic review on methodology of randomized controlled trials of post-marketing Chinese patent drugs for treatment of type 2 diabetes].

Science.gov (United States)

Ma, Li-xin; Wang, Yu-yi; Li, Xin-xue; Liu, Jian-ping

2012-03-01

Randomized controlled trial (RCT) is considered as the gold standard for the efficacy assessment of medicines. With the increasing number of Chinese patent drugs for treatment of type 2 diabetes, the methodology of post-marketing RCTs evaluating the efficacy and specific effect has become more important. To investigate post-marketing Chinese patent drugs for treatment of type 2 diabetes, as well as the methodological quality of post-marketing RCTs. Literature was searched from the books of Newly Compiled Traditional Chinese Patent Medicine and Chinese Pharmacopeia, the websites of the State Food and Drug Administration and the Ministry of Human Resources and Social Security of the People's Republic of China, China National Knowledge Infrastructure Database, Chongqing VIP Chinese Science and Technology Periodical Database, Chinese Biomedical Database (SinoMed) and Wanfang Data. The time period for searching ran from the commencement of each database to August 2011. RCTs of post-marketing Chinese patent drugs for treatment of type 2 diabetes with intervention course no less than 3 months. Two authors independently evaluated the research quality of the RCTs by the checklist of risk bias assessment and the data collection forms based on the CONSORT Statement. Independent double data-extraction was performed. The authors identified a total of 149 Chinese patent drugs for treatment of type 2 diabetes. According to different indicative syndromes, the Chinese patent drugs can be divided into the following types, namely, yin deficiency and interior heat (n=48, 32%), dual deficiency of qi and yin (n=58, 39%) and dual deficiency of qi and yin combined with blood stasis (n=22, 15%). A total of 41 RCTs meeting the inclusion criteria were included. Neither multicenter RCTs nor endpoint outcome reports were found. Risk bias analysis showed that 81% of the included studies reported randomization for grouping without sequence generation, 98% of these studies did not report

Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.

Science.gov (United States)

Schick, Andreas; Miller, Kathleen L; Lanthier, Michael; Dal Pan, Gerald; Nardinelli, Clark

2017-06-01

An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions. We study this question using an internal FDA database containing every new small molecule drug submitted to the FDA's Center for Drug Evaluation and Research (CDER) on or after November 21, 1997, and approved and commercially launched before December 31, 2009. Serious post-marketing safety actions include whether these drugs ever experienced either a post-marketing boxed warning or a withdrawal from the market due to safety concerns. A random effects logistic regression model was used to test whether any pre-marketing characteristics were associated with either post-marketing safety action. A total of 219 new molecular entities were analyzed. Among these drugs, 11 experienced a safety withdrawal and 30 received boxed warnings by July 31, 2016. Contrary to prevailing hypotheses, we find that neither clinical trial sample sizes nor review time windows are associated with the addition of a post-marketing boxed warning or safety withdrawal. However, we do find that new drugs approved with either a boxed warning or priority review are more likely to experience post-marketing boxed warnings. Furthermore, drugs approved with boxed warnings tend to receive post-marketing boxed warnings resulting from new safety information that are unrelated to the original warning. Drugs approved with a boxed warning are 3.88 times more likely to receive a post-marketing boxed warning, while drugs approved with a priority review are 3.51 times more likely to receive a post

The effect of tranexamic acid on the risk of death and hysterectomy in women with post-partum haemorrhage: statistical analysis plan for the WOMAN trial.

Science.gov (United States)

Shakur, Haleema; Roberts, Ian; Edwards, Philip; Elbourne, Diana; Alfirevic, Zarko; Ronsmans, Carine

2016-05-17

Severe haemorrhage is a leading cause of maternal death worldwide. Most haemorrhage deaths occur soon after childbirth. Severe post-partum bleeding is sometimes managed by the surgical removal of the uterus (hysterectomy). Death and hysterectomy are important health consequences of post-partum haemorrhage, and clinical trials of interventions aimed at preventing these outcomes are needed. The World Maternal Antifibrinolytic trial aims to determine the effect of tranexamic acid on death, hysterectomy and other health outcomes in women with post-partum haemorrhage. It is an international, multicentre, randomised trial. Approximately 20,000 women with post-partum haemorrhage will be randomly allocated to receive an intravenous injection of either tranexamic acid or matching placebo in addition to usual care. The primary outcome measure is a composite of death in hospital or hysterectomy within 42 days of delivery. The cause of death will be described. Secondary outcomes include death, death due to bleeding, hysterectomy, thromboembolic events, blood transfusion, surgical and radiological interventions, complications, adverse events and quality of life. The health status and occurrence of thromboembolic events in breastfed babies will also be reported. We will conduct subgroup analyses for the primary outcome by time to treatment, type of delivery and cause of haemorrhage. We will conduct an analysis of treatment effect adjusted for baseline risk. The World Maternal Antifibrinolytic trial should provide reliable evidence for the efficacy of tranexamic acid in the prevention of death, hysterectomy and other outcomes that are important to patients. We present a protocol update and the statistical analysis plan for the trial. Current Controlled Trials ISRCTN76912190 (Registration date 08 December 2008), Clinicaltrials.gov NCT00872469 (Registration date 30 March 2009) and Pan African Clinical Trials Registry: PACTR201007000192283 (Registration date 02 September 2010).

Post-discharge management following hip fracture - get you back to B4: A parallel group, randomized controlled trial study protocol

Directory of Open Access Journals (Sweden)

Brown Roy A

2011-06-01

Full Text Available Abstract Background Fall-related hip fractures result in significant personal and societal consequences; importantly, up to half of older adults with hip fracture never regain their previous level of mobility. Strategies of follow-up care for older adults after fracture have improved investigation for osteoporosis; but managing bone health alone is not enough. Prevention of fractures requires management of both bone health and falls risk factors (including the contributing role of cognition, balance and continence to improve outcomes. Methods/Design This is a parallel group, pragmatic randomized controlled trial to test the effectiveness of a post-fracture clinic compared with usual care on mobility for older adults following their hospitalization for hip fracture. Participants randomized to the intervention will attend a fracture follow-up clinic where a geriatrician and physiotherapist will assess and manage their mobility and other health issues. Depending on needs identified at the clinical assessment, participants may receive individualized and group-based outpatient physiotherapy, and a home exercise program. Our primary objective is to assess the effectiveness of a novel post-discharge fracture management strategy on the mobility of older adults after hip fracture. We will enrol 130 older adults (65 years+ who have sustained a hip fracture in the previous three months, and were admitted to hospital from home and are expected to be discharged home. We will exclude older adults who prior to the fracture were: unable to walk 10 meters; diagnosed with dementia and/or significant comorbidities that would preclude their participation in the clinical service. Eligible participants will be randomly assigned to the Intervention or Usual Care groups by remote allocation. Treatment allocation will be concealed; investigators, measurement team and primary data analysts will be blinded to group allocation. Our primary outcome is mobility

Imaging evaluation of post pancreatic surgery

International Nuclear Information System (INIS)

Scialpi, Michele; Scaglione, Mariano; Volterrani, Luca; Lupattelli, Luciano; Ragozzino, Alfonso; Romano, Stefania; Rotondo, Antonio

2005-01-01

The role of several imaging techniques in patients submitted to pancreatic surgery with special emphasis to single-slice helical computed tomography (CT) and multidetector-row CT (MDCT) was reviewed. Several surgical options may be performed such as Whipple procedure, distal pancreatectomy, central pancreatectomy, and total pancreatectomy. Ultrasound examination may be used to detect peritoneal fluid in the early post-operative period as well as lesion recurrence in long-term follow-up. Radiological gastrointestinal studies has a major role in evaluation of intestinal functionality. In spite of the advent of other imaging modalities, CT is the most effective after pancreatic surgery. On post-operative CT, the most common findings were small fluid peritoneal or pancreatic collections, stranding of the mesenteric fat with perivascular cuffing, reactive adenopathy and pneumobilia. In addition, CT may demonstrate early (leakage of anastomosis, pancreatico-jejunal fistula, haemorrage, acute pancreatitis of the remnant pancreas, peritonitis), and late (chronic fistula, abscess, aneurysms, anastomotic bilio-digestive stenosis, perianastomotic ulcers, biloma, and intra-abdominal bleeding) surgical complications. In the follow-up evaluation, CT may show tumor recurrence, liver and lymph nodes metastasis. Magnetic resonance may be used as alternative imaging modality to CT, when renal insufficiency or contrast sensitivity prevents the use of iodinated i.v. contrast material or when the biliary tree study is primarily requested. The knowledge of the type of surgical procedures, the proper identification of the anastomoses as well as the normal post-operative imaging appearances are essential for an accurate detection of the complications and recurrent disease

Imaging evaluation of post pancreatic surgery

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Scialpi, Michele [Department of Radiology, ' Santissima Annunziata' Hospital, Via Bruno 1, I-74100 Taranto (Italy)]. E-mail: michelescialpi@libero.it; Scaglione, Mariano [Department of Radiology, ' A. Cardarelli' Hospital, I-80131 Naples (Italy); Volterrani, Luca [Institute of Radiology, University of Siena, I-53100 Siena (Italy); Lupattelli, Luciano [Institute of Radiology, University of Perugia, I-06122 Perugia (Italy); Ragozzino, Alfonso [Department of Radiology, ' A. Cardarelli' Hospital, I-80131 Naples (Italy); Romano, Stefania [Department of Radiology, ' A. Cardarelli' Hospital, I-80131 Naples (Italy); Rotondo, Antonio [Section of Radiology, Department ' Magrassi-Lanzara' , Second University, I-80138 Naples (Italy)

2005-03-01

The role of several imaging techniques in patients submitted to pancreatic surgery with special emphasis to single-slice helical computed tomography (CT) and multidetector-row CT (MDCT) was reviewed. Several surgical options may be performed such as Whipple procedure, distal pancreatectomy, central pancreatectomy, and total pancreatectomy. Ultrasound examination may be used to detect peritoneal fluid in the early post-operative period as well as lesion recurrence in long-term follow-up. Radiological gastrointestinal studies has a major role in evaluation of intestinal functionality. In spite of the advent of other imaging modalities, CT is the most effective after pancreatic surgery. On post-operative CT, the most common findings were small fluid peritoneal or pancreatic collections, stranding of the mesenteric fat with perivascular cuffing, reactive adenopathy and pneumobilia. In addition, CT may demonstrate early (leakage of anastomosis, pancreatico-jejunal fistula, haemorrage, acute pancreatitis of the remnant pancreas, peritonitis), and late (chronic fistula, abscess, aneurysms, anastomotic bilio-digestive stenosis, perianastomotic ulcers, biloma, and intra-abdominal bleeding) surgical complications. In the follow-up evaluation, CT may show tumor recurrence, liver and lymph nodes metastasis. Magnetic resonance may be used as alternative imaging modality to CT, when renal insufficiency or contrast sensitivity prevents the use of iodinated i.v. contrast material or when the biliary tree study is primarily requested. The knowledge of the type of surgical procedures, the proper identification of the anastomoses as well as the normal post-operative imaging appearances are essential for an accurate detection of the complications and recurrent disease.

Ex-post evaluation of tax legislation in the Netherlands

NARCIS (Netherlands)

S.J.C. Hemels (Sigrid)

2011-01-01

textabstractIntroduction Since the end of the 20th century, ex-post evaluation of tax legislation has consistently been part of the agenda of the Dutch government. In 2005, the 2001 Income tax Act was evaluated. In addition, several tax expenditures are evaluated each year. Tax expenditures can be a

Gabapentin May Relieve Post-Coronary Artery Bypass Graft Pain: A Double Blind Randomized Clinical Trial

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MSoltanzadeh

2011-09-01

Full Text Available Background: One of the most common complaints after coronary artery bypass graft (CABG is post-operative pain. Gabapentin is an anticonvulsant and antineuralgic agent. Objective: To evaluate the analgesic effect of preemptive gabapentin on post-operative pain and morphine consumption after cardiac surgery. Methods: A double-blind randomized clinical trial was conducted on 60 male candidates for CABG. The patients were divided into two groups—the gabapentin (n=30 and the control group (n=30. The test group received 800 mg gabapentin orally two hours before the surgery followed by 400 mg of the drug two hours post-extubation. The control group received placebo instead. Then severity of pain was recorded according to an 11-point visual analog pain scale. The amount of morphine consumed, its side effects and hemodynamic changes were also recorded during and at 2, 6, 12, 18 and 24 hours after extubation. Results: The mean±SD cumulative morphine consumption at the first 24 hours after extubation in gabapentin group was 0.9±1.5 mg while it was 1.5±4 mg for the control group. Therefore, gabapentin group consumed 38% less than the control group (P=0.01. The pain scores during rest and coughing at 2, 6, and 12 hours after extubation were also significantly lower in the gabapentin group compared with the control group (P=0.02. The mean±SD mechanical ventilation time was 5.4±1.7 hours for gabapentin group and 1.6±4.4 hours for the control group (P=0.035. The other variables including hemodynamic changes (HR, SBP and DBP, and incidence of nausea, vomiting and respiratory depression showed no significant difference between the studied groups within 24 hours after extubation. Conclusion: Oral pre-medication with gabapentin before CABG significantly reduces post-operative pain and morphine consumption in adult cardiac surgery.

Evaluation of Salivary Flow Rate, pH and Buffer in Pre, Post & Post Menopausal Women on HRT.

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D R, Mahesh; G, Komali; K, Jayanthi; D, Dinesh; T V, Saikavitha; Dinesh, Preeti

2014-02-01

Climateric is considered to be a natural phase of life which by definition is the period of life starting from decline in ovarian activity until after the end of ovarian function. It is accompanied by various health consequences that include the changes in saliva too. This study was carried out to evaluate the salivary flow rate, pH, buffering capacity in pre-menopausal, post-menopausal and post-menopausal women on HRT. (1) To evaluate the salivary flow rate, pH of resting saliva and stimulated saliva and buffer capacity of stimulated saliva in pre-menopausal, post-menopausal and post-menopausal women on Hormone Replacement Therapy (HRT). (2) To compare the above salivary findings between pre-menopausal, post-menopausal and post-menopausal women on HRT. The study was carried out on 60 patients. These patients were divided into three groups of 20 patients: Group 1: Pre-menopausal women (control), Group 2: post-menopausal women (case), Group 3: post-menopausal women on HRT (case). The control group consisted of 20 women volunteers, having regular ovulatory menstrual cycles with no known systemic illness and deleterious habits and Group 2 consists of 20 post-menopausal women and Group 3 will consist of 20 post-menopausal women on HRT. After clearing the mouth by swallowing, stimulated saliva was collected after chewing paraffin for 10 mins in to a glass centrifuge tube graded in 0.1 mL increments up to 10mL.in rare cases the collection time will be reduced or extended (5-15 min), salivary flow rate will be determined as ml/min, immediately after collection, pH was determined by dipping pH test paper directly into the sample of oral fluid, salivary buffer capacity was determined by using saliva check buffer kit (GC corporation). The data obtained was statistically evaluated using chi-square test, fisher exact test ANOVA analysis. In our study we found salivary flow rate significantly lower in the post-menopausal women in comparison with the menstruating women and also

Travel websites: Changing visits, evaluations and posts

NARCIS (Netherlands)

Bronner, Fred; de Hoog, Robert

2016-01-01

Many studies concerning the role of web-based information in tourism measure one-time interactions. This paper presents results of a longitudinal study. Data collected in 2014 about website visits, evaluations and posts, are compared with data from 2007. The main finding is the advance of sites

Clinical evaluation of post-extraction site wound healing.

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Adeyemo, Wasiu Lanre; Ladeinde, Akinola Ladipo; Ogunlewe, Mobolanle Olugbemiga

2006-07-01

The aim of this prospective study was to evaluate the clinical pattern of post-extraction wound healing with a view to identify the types, incidence, and pattern of healing complications following non-surgical tooth extraction. A total of 311 patients, who were referred for non-surgical (intra-alveolar) extractions, were included in the study. The relevant pre-operative information recorded for each patient included age and gender of the patient, indications for extraction, and tooth/teeth removed. Extractions were performed under local anesthesia with dental forceps, elevators, or both. Patients were evaluated on the third and seventh postoperative days for alveolus healing assessment. Data recorded were: biodata, day of presentation for alveolus healing assessment, day of onset of any symptoms, body temperature (degrees C) in cases of alveolus infection, and presence or absence of pain. Two hundred eighty-two patients (282) with 318 extraction sites were evaluated for alveolus healing. Healing was uneventful in 283 alveoli (89%), while 35 alveoli (11%) developed healing complications. These complications were: localized osteitis 26 (8.2%); acutely infected alveolus 5 (1.6%); and an acutely inflamed alveolus 4 (1.2%). Females developed more complications than males (p=0.003). Most complications were found in molars (60%) and premolars (37.1%). Localized osteitis caused severe pain in all cases, while infected and inflamed alveolus caused mild or no pain. Thirty patients (12%) among those without healing complications experienced mild pain. Most of the post-extraction alveoli healed uneventfully. Apart from alveolar osteitis (AO), post-extraction alveolus healing was also complicated by acutely infected alveoli and acutely inflamed alveoli. This study also demonstrated a painful alveolus is not necessarily a disturbance of post-extraction site wound healing; a thorough clinical examination must, therefore, be made to exclude any of the complications.

Evaluation of the pattern dimensions of cast-metal posts in uniradicular teeth

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Rafael de Assunção Vital

Full Text Available Introduction Accurate dimensions of cast-metal posts are relevant to the survival of dental prostheses. Objective The aim of this study was to verify if the dimensions of cast-metal posts accord with ideal clinical criteria. Material and method For the evaluation, 285 periapical radiographs, from a total of 80 teeth, were taken from the charts of patients that attended the clinics at the Dental School of the Federal University of Goiás, from March 2008 to October 2012. Only periapical radiographs of single-rooted teeth with post and core were included in the study. The radiographic evaluation was conducted with the assistance of a magnifying glass and a view box, in a room with low luminosity. The dimensions of the post and core were established with the help of a digital caliper, and the following measurements were considered: a LR (Length Remnant; b LP (Length Post; c BS (Bone Support; d DR (Diameter Root; e DP (mesiodistal diameter post. The post and core were classified as acceptable or deficient by reference values with a margin of error of 0.2 mm. For descriptive analysis, the data were cataloged using SPSS software (version 17.0. Result With regard to the length of the post and core, only 26.25% and 43.75% of the post and core were classified as acceptable according to the two-thirds rule and fulcrum dental rule, respectively. With regard to the mesiodistal diameter of the post and core, 55% were classified as acceptable. Conclusion Within the limits of this study, it can be concluded that the cast-metal posts evaluated do not accord with the ideal clinical criteria.

Evaluating the Flipped Classroom: A Randomized Controlled Trial

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Wozny, Nathan; Balser, Cary; Ives, Drew

2018-01-01

Despite recent interest in flipped classrooms, rigorous research evaluating their effectiveness is sparse. In this study, the authors implement a randomized controlled trial to evaluate the effect of a flipped classroom technique relative to a traditional lecture in an introductory undergraduate econometrics course. Random assignment enables the…

Early motion and directed exercise (EMADE) versus usual care post ankle fracture fixation: study protocol for a pragmatic randomised controlled trial.

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Matthews, Paul A; Scammell, Brigitte E; Ali, Arfan; Coughlin, Timothy; Nightingale, Jessica; Khan, Tanvir; Ollivere, Ben J

2018-05-31

Following surgical fixation of ankle fractures, the traditional management has included immobilisation for 6 weeks in a below-knee cast. However, this can lead to disuse atrophy of the affected leg and joint stiffness. While early rehabilitation from 2 weeks post surgery is viewed as safe, controversy remains regarding its benefits. We will compare the effectiveness of early motion and directed exercise (EMADE) ankle rehabilitation, against usual care, i.e. 6 weeks' immobilisation in a below-knee cast. We have designed a pragmatic randomised controlled trial (p-RCT) to compare the EMADE intervention against usual care. We will recruit 144 independently living adult participants, absent of tissue-healing comorbidities, who have undergone surgical stabilisation of isolated Weber B ankle fractures. The EMADE intervention consists of a non-weight-bearing progressive home exercise programme, complemented with manual therapy and education. Usual care consists of immobilisation in a non-weight-bearing below-knee cast. The intervention period is between week 2 and week 6 post surgery. The primary outcome is the Olerud and Molander Ankle Score (OMAS) patient-reported outcome measure (PROM) at 12 weeks post surgery. Secondary PROMs include the EQ-5D-5 L questionnaire, return to work and return to driving, with objective outcomes including ankle range of motion. Analysis will be on an intention-to-treat basis. An economic evaluation will be included. The EMADE intervention is a package of care designed to address the detrimental effects of disuse atrophy and joint stiffness. An advantage of the OMAS is the potential of meta-analysis with other designs. Within the economic evaluation, the cost-utility analysis, may be used by commissioners, while the use of patient-relevant outcomes, such as return to work and driving, will ensure that the study remains pertinent to patients and their families. As it is being conducted in the clinical environment, this p-RCT has high external

Pressure and pain In Systemic sclerosis/Scleroderma - an evaluation of a simple intervention (PISCES: randomised controlled trial protocol

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Alcacer-Pitarch Begonya

2012-02-01

Full Text Available Abstract Background Foot problems associated with Systemic Sclerosis (SSc/Scleroderma have been reported to be both common and disabling. There are only limited data describing specifically, the mechanical changes occurring in the foot in SSc. A pilot project conducted in preparation for this trial confirmed the previous reports of foot related impairment and reduced foot function in people with SSc and demonstrated a link to mechanical etiologies. To-date there have been no formal studies of interventions directed at the foot problems experienced by people with Systemic Sclerosis. The primary aim of this trial is to evaluate whether foot pain and foot-related health status in people with Systemic Sclerosis can be improved through the provision of a simple pressure-relieving insole. Methods The proposed trial is a pragmatic, multicenter, randomised controlled clinical trial following a completed pilot study. In four participating centres, 140 consenting patients with SSc and plantar foot pain will be randomised to receive either a commercially available pressure relieving and thermally insulating insole, or a sham insole with no cushioning or thermal properties. The primary end point is a reduction in pain measured using the Foot Function Index Pain subscale, 12 weeks after the start of intervention. Participants will complete the primary outcome measure (Foot Function Index pain sub-scale prior to randomisation and at 12 weeks post randomisation. Secondary outcomes include participant reported pain and disability as derived from the Manchester Foot Pain and Disability Questionnaire and plantar pressures with and without the insoles in situ. Discussion This trial protocol proposes a rigorous and potentially significant evaluation of a simple and readily provided therapeutic approach which, if effective, could be of a great benefit for this group of patients. Trial registration number ISRCTN: ISRCTN02824122

The PAV trial: Does lactobacillus prevent post-antibiotic vulvovaginal candidiasis? Protocol of a randomised controlled trial [ISRCTN24141277

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Hurley Susan

2004-03-01

Full Text Available Abstract Background Complementary and alternative medicines are used by many consumers, and increasingly are being incorporated into the general practitioner's armamentarium. Despite widespread usage, the evidence base for most complementary therapies is weak or non-existent. Post-antibiotic vulvovaginitis is a common problem in general practice, for which complementary therapies are often used. A recent study in Melbourne, Australia, found that 40% of women with a past history of vulvovaginitis had used probiotic Lactobacillus species to prevent or treat post-antibiotic vulvovaginitis. There is no evidence that this therapy is effective. This study aims to test whether oral or vaginal lactobacillus is effective in the prevention of post-antibiotic vulvovaginitis. Methods/design A randomised placebo-controlled blinded 2 × 2 factorial design is being used. General practitioners or pharmacists approach non-pregnant women, aged 18–50 years, who present with a non-genital infection requiring a short course of oral antibiotics, to participate in the study. Participants are randomised in a four group factorial design either to oral lactobacillus powder or placebo and either vaginal lactobacillus pessaries or placebo. These interventions are taken while on antibiotics and for four days afterwards or until symptoms of vaginitis develop. Women self collect a vaginal swab for culture of Candida species and complete a survey at baseline and again four days after completing their study medications. The sample size (a total of 496 – 124 in each factorial group is calculated to identify a reduction of half in post-antibiotic vulvovaginitis from 23%, while allowing for a 25% drop-out. An independent Data Monitoring Committee is supervising the trial. Analysis will be intention-to-treat, with two pre-specified main comparisons: (i oral lactobacillus versus placebo and (ii vaginal lactobacillus versus placebo.

The Post-Discharge Network Coordination Programme (PDNC-P: A randomised controlled trial to evaluate the efficacy of an intervention aimed at reducing rehospitalisations and improving mental health

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Michael Pascal Hengartner

2016-03-01

Full Text Available Purpose: To evaluate the efficacy of a post-discharge intervention for psychiatric inpatients aimed at preventing hospital readmissions and at improving patients’ mental health and psychosocial functioning. Methods: RCT using parallel group block randomisation including 151 patients with ≤3 hospitalisations within the last three years, a GAF score ≤60, and aged 18–64 years, assessed at two psychiatric hospitals from the canton of Zurich, Switzerland, between September 2011 and February 2014. Primary outcomes were rate and duration of rehospitalisation; secondary outcomes were mental health and functioning. Outcome measures were assessed before discharge from the index hospitalisation (t0, 3 months after discharge when the intervention terminated (t1, and 12 months after discharge (t2. Participants received either a brief case management post-discharge intervention or treatment as usual.Results: In the short-term (i.e., t0-t1 no significant effect emerged in any outcome. In the long-term (i.e., t0-t2 the two groups did not differ significantly with respect to the rate and duration of rehospitalisation. Also, the intervention did not reduce psychiatric symptoms, did not improve social support and did not improve quality of life. However, it did slightly increase assessor-rated general (d=0.30 and social functioning (d=0.42, although self-reports revealed a deteriorative effect on symptom remission (d=-0.44.Conclusions: This psychosocial post-discharge intervention showed no efficacy in the primary outcome of rehospitalisation. With respect to secondary outcomes, in the long-term it might lead to slightly increased social functioning but revealed no significant effect on psychopathology, social support and quality of life. In contrast, with respect to self-reported symptom remission, it was revealed to have a negative effect. In this high-resource catchment area with comprehensive community psychiatric and social services the intervention

Clinical evaluation of a novel dental implant system as single implants under immediate loading conditions - 4-month post-loading results from a multicentre randomised controlled trial.

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Esposito, Marco; Trullenque-Eriksson, Anna; Blasone, Rodolfo; Malaguti, Giuliano; Gaffuri, Cristiano; Caneva, Marco; Minciarelli, Armando; Luongo, Giuseppe

To evaluate the safety and clinical effectiveness of a novel dental implant system (GENESIS Implant System, Keystone Dental, Massachusetts, USA) using another dental implant system by the same manufacturer as a control (PRIMA Implant System, Keystone Dental). A total of 53 patients requiring at least two single crowns had their sites randomised according to a split-mouth design to receive both implant systems at six centres. If implants could be placed with a torque superior to 40 Ncm they were to be loaded immediately with provisional crowns, otherwise after 3 months of submerged healing. Provisional crowns were replaced by definitive crowns 4 months after initial loading, when the follow-up period for the initial part of this study was completed. Outcome measures were crown/implant failures, complications, pink esthetic score (PES), peri-implant marginal bone level changes, plaque score, marginal bleeding, patients and preference of the clinician. In total 53 PRIMA and 53 GENESIS implants were placed. Three patients dropped out but all of the remaining patients were followed up to 4-months post-loading. No PRIMA implant failed whereas four GENESIS implants failed. Only two complications were reported for PRIMA implants. There were no statistically significant differences for crown/implant failures (difference in proportions = 0.080; P (McNemar test) = 0.125) and complications (difference in proportions = -0.04; P (McNemar test) = 0.500) between the implant systems. There were no differences at 4-months post-loading for plaque (difference = -0.54, 95% CI: -3.01 to 1.93; P (Paired t-test) = 0.660), marginal bleeding (difference = -3.8, 95% CI: -7.63 to 0.019; P (Paired t-test) = 0.051), PES (difference = 0.47, 95% CI: -0.56 to 1.50; P (Paired t-test) = 0.365) and marginal bone level changes (difference in mm = -0.04, 95% CI: -0.33 to 0.26; P (Paired t-test) = 0.795). The majority of the patients (46) had no

Glyceryl trinitrate for prevention of post-ERCP pancreatitis and improve the rate of cannulation: a meta-analysis of prospective, randomized, controlled trials.

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Jiexia Ding

Full Text Available BACKGROUND: Acute pancreatitis is the most common complication of diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP. Several clinical trials used glyceryl trinitrate (GTN to prevent the incidence of post-ERCP pancreatitis (PEP. However, the results were still controversial. OBJECTIVE: To conduct a meta-analysis of published, full-length, randomized controlled trials evaluating the effect of prophylactic GTN on the prevention of PEP, improve the rate of cannulation and the prevention of hyperamylasemia. METHODS: Literature searches were conducted using PubMed, EMBASE, The Cochrane Library and Web of Knowledge databases, using keywords "post-ERCP" and "pancreatitis" and limited in randomized controlled trials. RESULTS: Twelve RCTs involving 2649 patients were included. Eleven RCTs compared GTN with placebo for PEP prevention. Meta-analysis showed the overall incidence of PEP was significantly reduced by GTN treatment (RR 0.67; 95% CI, 0.52-0.87. Nevertheless, GTN administration did not decrease the incidence of moderate to severe PEP (RR 0.70; 95% CI, 0.42-1.15. Subgroup analyses revealed that GTN administered by sublingual was more effective than transdermal and topical in reducing the incidence of PEP. Besides, the prophylactic effect of GTN was far more obvious in the group of high PEP incidence than in the group of low PEP incidence. Additionally, the incidence of hyperamylasemia was significantly reduced by GTN treatment (RR 0.69; 95% CI, 0.54-0.90. No differences of the successful cannulation rate of bile ducts (RR 1.03; 95% CI, 0.99-1.06 attributable to GTN were observed. CONCLUSION: Prophylactic use of GTN reduced the overall incidence of PEP and hyperamylasemia. However, GTN was not helpful for the severity of PEP and the rate of cannulation.

Evaluating Adaptation of a Cancer Clinical Trial Decision Aid for Rural Cancer Patients: A Mixed-Methods Approach.

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Pathak, Swati; George, Nerissa; Monti, Denise; Robinson, Kathy; Politi, Mary C

2018-06-03

Rural-residing cancer patients often do not participate in clinical trials. Many patients misunderstand cancer clinical trials and their rights as participant. The purpose of this study is to modify a previously developed cancer clinical trials decision aid (DA), incorporating the unique needs of rural populations, and test its impact on knowledge and decision outcomes. The study was conducted in two phases. Phase I recruited 15 rural-residing cancer survivors in a qualitative usability study. Participants navigated the original DA and provided feedback regarding usability and implementation in rural settings. Phase II recruited 31 newly diagnosed rural-residing cancer patients. Patients completed a survey before and after using the revised DA, R-CHOICES. Primary outcomes included decisional conflict, decision self-efficacy, knowledge, communication self-efficacy, and attitudes towards and willingness to consider joining a trial. In phase I, the DA was viewed positively by rural-residing cancer survivors. Participants provided important feedback about factors rural-residing patients consider when thinking about trial participation. In phase II, after using R-CHOICES, participants had higher certainty about their choice (mean post-test = 3.10 vs. pre-test = 2.67; P = 0.025) and higher trial knowledge (mean percentage correct at post-test = 73.58 vs. pre-test = 57.77; P decision self-efficacy, communication self-efficacy, and attitudes towards or willingness to join trials. The R-CHOICES improved rural-residing patients' knowledge of cancer clinical trials and reduced conflict about making a trial decision. More research is needed on ways to further support decisions about trial participation among this population.

Are we drawing the right conclusions from randomised placebo-controlled trials? A post-hoc analysis of data from a randomised controlled trial

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Bone Kerry M

2009-06-01

Full Text Available Abstract Background Assumptions underlying placebo controlled trials include that the placebo effect impacts on all study arms equally, and that treatment effects are additional to the placebo effect. However, these assumptions have recently been challenged, and different mechanisms may potentially be operating in the placebo and treatment arms. The objective of the current study was to explore the nature of placebo versus pharmacological effects by comparing predictors of the placebo response with predictors of the treatment response in a randomised, placebo-controlled trial of a phytotherapeutic combination for the treatment of menopausal symptoms. A substantial placebo response was observed but no significant difference in efficacy between the two arms. Methods A post hoc analysis was conducted on data from 93 participants who completed this previously published study. Variables at baseline were investigated as potential predictors of the response on any of the endpoints of flushing, overall menopausal symptoms and depression. Focused tests were conducted using hierarchical linear regression analyses. Based on these findings, analyses were conducted for both groups separately. These findings are discussed in relation to existing literature on placebo effects. Results Distinct differences in predictors were observed between the placebo and active groups. A significant difference was found for study entry anxiety, and Greene Climacteric Scale (GCS scores, on all three endpoints. Attitude to menopause was found to differ significantly between the two groups for GCS scores. Examination of the individual arms found anxiety at study entry to predict placebo response on all three outcome measures individually. In contrast, low anxiety was significantly associated with improvement in the active treatment group. None of the variables found to predict the placebo response was relevant to the treatment arm. Conclusion This study was a post hoc analysis

Evaluation of the physicians‘ of n hospital opinion on clinical trials of medicinal products

OpenAIRE

Videikaitė, Lina

2014-01-01

Aim of the research. To evaluate the physicians‘ of N Hospital opinion on clinical trials of medicinal products. Objectives. To evaluate the factors affecting physicians' motivation to perform clinical trials of medicinal products as well as those that prevent the physicians getting involved in the trials. To assess physicians' attitude towards clinical trials of medicinal products. To compare the opinions of physicians who have and have’nt participated in clinical trials. Methods of...

Phase II feasibility trial of adjuvant chemoradiotherapy with 3-weekly cisplatin for Japanese patients with post-operative high-risk squamous cell carcinoma of the head and neck

International Nuclear Information System (INIS)

Kiyota, Naomi; Tahara, Makoto; Okano, Susumu

2012-01-01

The current standard of care for post-operative high-risk squamous cell carcinoma of the head and neck is concurrent chemoradiotherapy with a 3-weekly cycle of cisplatin (3W-CDDP/RT). In previous pivotal trials, the complete delivery rate of three cycles of cisplatin and radiation therapy was only -60%. Here, we evaluated the feasibility and safety of 3W-CDDP/RT in a Japanese population. The study enrolled post-operative high-risk squamous cell carcinoma of the head and neck patients. High-risk factors were a microscopically incomplete resection, extracapsular extension and two or more lymph node metastases. Subjects received three cycles of cisplatin at a dose of 100 mg/m 2 concomitant with radiation therapy (66 Gy/33 Fr). From August 2006 to May 2009, 25 eligible subjects were accrued, including 13 males, with a median age of 59 years, Eastern Cooperative Oncology Group performance status 0/1 (18/7), Stage III/IVA/IVB/recurrent (1/18/1/5) and oral cavity/oropharynx/hypopharynx/larynx (17/4/3/1). Protocol completion rate was 80%. The lower limit of the one-sided 90% confidence interval was 66%, which met the predefined statistical criteria. Grade 3/4 acute and late toxicities were almost identical to those in previous pivotal trials. No treatment-related deaths were observed. With a median follow-up of 39 months, 14 have had progression and 10 have died. Estimated 3-year locoregional control rate, relapse-free survival and overall survival were 74, 43 and 60%, respectively. On univariate analysis, oral cavity cancer and a cumulative cisplatin dose below 240 mg/m 2 appeared to be poor prognostic factors. This is the first Phase II feasibility trial of adjuvant chemoradiotherapy with 3-weekly cisplatin for post-operative high-risk squamous cell carcinoma of the head and neck in a Japanese population. This treatment was feasible and the safety profile was identical to those in pivotal Phase III trials. (author)

Therapeutic Effect of Virtual Reality on Post-Stroke Patients: Randomized Clinical Trial.

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Pedreira da Fonseca, Erika; Ribeiro da Silva, Nildo Manoel; Pinto, Elen Beatriz

2017-01-01

The study aimed to check the therapeutic effect of virtual reality associated with conventional physiotherapy on gait balance and the occurrence of falls after a stroke. This was a randomized, blinded clinical trial conducted with post-stroke patients, randomized into two groups-treatment group and control group-and subjected to balance assessments by the Dynamic Gait Index and investigation of falls before and after 20 intervention sessions. Statistically significant difference was considered at P < .05. We selected 30 patients, but there were three segment losses, resulting in a total of 13 patients in the control group and 14 in the treatment group. There was an improvement in gait balance and reduced occurrence of falls in both groups. After intervention, the differences in gait balance in the control group (P = .047) and the reduction in the occurrence of falls in the treatment group (P = .049) were significant. However, in intergroup analysis, there was no difference in the two outcomes. Therapy with games was a useful tool for gait balance rehabilitation in post-stroke patients, with repercussions on the reduction of falls. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Randomized controlled trial of internal and external targeted temperature management methods in post- cardiac arrest patients.

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Look, Xinqi; Li, Huihua; Ng, Mingwei; Lim, Eric Tien Siang; Pothiawala, Sohil; Tan, Kenneth Boon Kiat; Sewa, Duu Wen; Shahidah, Nur; Pek, Pin Pin; Ong, Marcus Eng Hock

2018-01-01

Targeted temperature management post-cardiac arrest is currently implemented using various methods, broadly categorized as internal and external. This study aimed to evaluate survival-to-hospital discharge and neurological outcomes (Glasgow-Pittsburgh Score) of post-cardiac arrest patients undergoing internal cooling verses external cooling. A randomized controlled trial of post-resuscitation cardiac arrest patients was conducted from October 2008-September 2014. Patients were randomized to either internal or external cooling methods. Historical controls were selected matched by age and gender. Analysis using SPSS version 21.0 presented descriptive statistics and frequencies while univariate logistic regression was done using R 3.1.3. 23 patients were randomized to internal cooling and 22 patients to external cooling and 42 matched controls were selected. No significant difference was seen between internal and external cooling in terms of survival, neurological outcomes and complications. However in the internal cooling arm, there was lower risk of developing overcooling (p=0.01) and rebound hyperthermia (p=0.02). Compared to normothermia, internal cooling had higher survival (OR=3.36, 95% CI=(1.130, 10.412), and lower risk of developing cardiac arrhythmias (OR=0.18, 95% CI=(0.04, 0.63)). Subgroup analysis showed those with cardiac cause of arrest (OR=4.29, 95% CI=(1.26, 15.80)) and sustained ROSC (OR=5.50, 95% CI=(1.64, 20.39)) had better survival with internal cooling compared to normothermia. Cooling curves showed tighter temperature control for internal compared to external cooling. Internal cooling showed tighter temperature control compared to external cooling. Internal cooling can potentially provide better survival-to-hospital discharge outcomes and reduce cardiac arrhythmia complications in carefully selected patients as compared to normothermia. Copyright © 2017. Published by Elsevier Inc.

[Opportunity and challenge of post-marketing evaluation of traditional Chinese medicine].

Science.gov (United States)

Du, Xiao-Xi; Song, Hai-Bo; Ren, Jing-Tian; Yang, Le; Guo, Xiao-Xin; Pang, Yu

2014-09-01

Post-marketing evaluation is a process which evaluate the risks and benefits of drug clinical application comprehensively and systematically, scientific and systematic results of post-marketing evaluation not only can provide data support for clinical application of traditional Chinese medicine, but also can be a reliable basis for the supervision department to develop risk control measures. With the increasing demands for treatment and prevention of disease, traditional Chinese medicine has been widely used, and security issues are also exposed. How to find risk signal of traditional Chinese medicine in the early stages, carry out targeted evaluation work and control risk timely have become challenges in the development of traditional Chinese medicine industry.

Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

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Balassy, Csilla [Medical University of Vienna, Vienna General Hospital, Department of Radiology, Division of General and Pediatric Radiology, Vienna (Austria); Roberts, Donna [Medical University of South Carolina, Department of Radiology, Charleston, SC (United States); Miller, Stephen F. [LeBonheur Children' s Hospital, Department of Radiology, Memphis, TN (United States)

2015-11-15

Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies.

Science.gov (United States)

Balassy, Csilla; Roberts, Donna; Miller, Stephen F

2015-11-01

Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children.

Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies

International Nuclear Information System (INIS)

Balassy, Csilla; Roberts, Donna; Miller, Stephen F.

2015-01-01

Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children. (orig.)

Evaluation of Pharmacists' Participation in Post-Admission Ward ...

African Journals Online (AJOL)

Objective: The study evaluates pharmacist's perception of and participation in post-admission ward rounds, at the Lagos University Teaching Hospital (LUTH). Method: All the 60 pharmacists covering various units of pharmaceutical services were administered a forty-two element structured questionnaire. Fifty (83.3%) ...

Evaluating the design and reporting of pragmatic trials in osteoarthritis research.

Science.gov (United States)

Ali, Shabana Amanda; Kloseck, Marita; Lee, Karen; Walsh, Kathleen Ellen; MacDermid, Joy C; Fitzsimmons, Deborah

2018-01-01

Among the challenges in health research is translating interventions from controlled experimental settings to clinical and community settings where chronic disease is managed daily. Pragmatic trials offer a method for testing interventions in real-world settings but are seldom used in OA research. The aim of this study was to evaluate the literature on pragmatic trials in OA research up to August 2016 in order to identify strengths and weaknesses in the design and reporting of these trials. We used established guidelines to assess the degree to which 61 OA studies complied with pragmatic trial design and reporting. We assessed design according to the pragmatic-explanatory continuum indicator summary and reporting according to the pragmatic trials extension of the CONsolidated Standards of Reporting Trials guidelines. None of the pragmatic trials met all 11 criteria evaluated and most of the trials met between 5 and 8 of the criteria. Criteria most often unmet pertained to practitioner expertise (by requiring specialists) and criteria most often met pertained to primary outcome analysis (by using intention-to-treat analysis). Our results suggest a lack of highly pragmatic trials in OA research. We identify this as a point of opportunity to improve research translation, since optimizing the design and reporting of pragmatic trials can facilitate implementation of evidence-based interventions for OA care. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Clinical feasibility of the Nintendo Wii™ for balance training post-stroke: a phase II randomized controlled trial in an inpatient setting.

Science.gov (United States)

Bower, Kelly J; Clark, Ross A; McGinley, Jennifer L; Martin, Clarissa L; Miller, Kimberly J

2014-09-01

To investigate the feasibility and potential efficacy of the Nintendo Wii™ for balance rehabilitation after stroke. Phase II, single-blind, randomized controlled trial. Inpatient rehabilitation facility. Thirty adults (mean age 63.6 (14.7) years) undergoing inpatient rehabilitation who were less than three months post-stroke and able to stand unsupported. Participants were allocated to a Balance Group, using the 'Wii Fit Plus' in standing, or Upper Limb Group, using the 'Wii Sports/Sports Resort' in sitting. Both groups undertook three 45 minute sessions per week over two to four weeks in addition to standard care. The primary focus was feasibility, addressed by recruitment, retention, adherence, acceptability and safety. Efficacy was evaluated by balance, mobility and upper limb outcomes. Twenty-one percent of individuals screened were recruited and 86% (n = 30) of eligible people agreed to participate. Study retention and session adherence was 90% and > 99%, respectively, at two weeks; dropping to 70% and 87% at four weeks due to early discharge. All participants reported enjoying the sessions and most felt they were beneficial. No major adverse events occurred. Wii use by the Balance Group was associated with trends for improved balance, with significantly greater improvement in outcomes including the Step Test and Wii Balance Board-derived centre of pressure scores. The Upper Limb Group had larger, non-significant changes in arm function. A Wii-based approach appears feasible and promising for post-stroke balance rehabilitation. A larger randomized controlled trial is recommended to further investigate efficacy. © The Author(s) 2014.

Bacteriological And Clinical Evaluation Of Twelve Cases Of Post ...

African Journals Online (AJOL)

Bacteriological And Clinical Evaluation Of Twelve Cases Of Post-Surgical Sepsis Of Odontogenic Tumours At A ... East African Medical Journal ... Intervention: Adequate review of patient\\'s medical history, bacteriological investigations and

[Application of Markov model in post-marketing pharmacoeconomic evaluation of traditional Chinese medicine].

Science.gov (United States)

Wang, Xin; Su, Xia; Sun, Wentao; Xie, Yanming; Wang, Yongyan

2011-10-01

In post-marketing study of traditional Chinese medicine (TCM), pharmacoeconomic evaluation has an important applied significance. However, the economic literatures of TCM have been unable to fully and accurately reflect the unique overall outcomes of treatment with TCM. For the special nature of TCM itself, we recommend that Markov model could be introduced into post-marketing pharmacoeconomic evaluation of TCM, and also explore the feasibility of model application. Markov model can extrapolate the study time horizon, suit with effectiveness indicators of TCM, and provide measurable comprehensive outcome. In addition, Markov model can promote the development of TCM quality of life scale and the methodology of post-marketing pharmacoeconomic evaluation.

The CAP study, evaluation of integrated universal and selective prevention strategies for youth alcohol misuse: study protocol of a cluster randomized controlled trial

Directory of Open Access Journals (Sweden)

Newton Nicola C

2012-08-01

Full Text Available Abstract Background Alcohol misuse amongst young people is a serious concern. The need for effective prevention is clear, yet there appear to be few evidenced-based programs that prevent alcohol misuse and none that target both high and low-risk youth. The CAP study addresses this gap by evaluating the efficacy of an integrated approach to alcohol misuse prevention, which combines the effective universal internet-based Climate Schools program with the effective selective personality-targeted Preventure program. This article describes the development and protocol of the CAP study which aims to prevent alcohol misuse and related harms in Australian adolescents. Methods/Design A cluster randomized controlled trial (RCT is being conducted with Year 8 students aged 13 to 14-years-old from 27 secondary schools in New South Wales and Victoria, Australia. Blocked randomisation was used to assign schools to one of four groups; Climate Schools only, Preventure only, CAP (Climate Schools and Preventure, or Control (alcohol, drug and health education as usual. The primary outcomes of the trial will be the uptake and harmful use of alcohol and alcohol related harms. Secondary outcomes will include alcohol and cannabis related knowledge, cannabis related harms, intentions to use, and mental health symptomatology. All participants will complete assessments on five occasions; baseline; immediately post intervention, and at 12, 24 and 36 months post baseline. Discussion This study protocol presents the design and current implementation of a cluster RCT to evaluate the efficacy of the CAP study; an integrated universal and selective approach to prevent alcohol use and related harms among adolescents. Compared to students who receive the stand-alone universal Climate Schools program or alcohol and drug education as usual (Controls, we expect the students who receive the CAP intervention to have significantly less uptake of alcohol use, a reduction in average

A Single-Blind randomized controlled trial to evaluate the effect of extended counseling on uptake of pre-antiretroviral care in eastern uganda

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Marrone Gaetano

2011-07-01

Full Text Available Abstract Background Many newly screened people living with HIV (PLHIV in Sub-Saharan Africa do not understand the importance of regular pre-antiretroviral (ARV care because most of them have been counseled by staff who lack basic counseling skills. This results in low uptake of pre-ARV care and late treatment initiation in resource-poor settings. The effect of providing post-test counseling by staff equipped with basic counseling skills, combined with home visits by community support agents on uptake of pre-ARV care for newly diagnosed PLHIV was evaluated through a randomized intervention trial in Uganda. Methods An intervention trial was performed consisting of post-test counseling by trained counselors, combined with monthly home visits by community support agents for continued counseling to newly screened PLHIV in Iganga district, Uganda between July 2009 and June 2010, Participants (N = 400 from three public recruitment centres were randomized to receive either the intervention, or the standard care (the existing post-test counseling by ARV clinic staff who lack basic training in counseling skills, the control arm. The outcome measure was the proportion of newly screened and counseled PLHIV in either arm who had been to their nearest health center for clinical check-up in the subsequent three months +2 months. Treatment was randomly assigned using computer-generated random numbers. The statistical significance of differences between the two study arms was assessed using chi-square and t-tests for categorical and quantitative data respectively. Risk ratios and 95% confidence intervals were used to assess the effect of the intervention. Results Participants in the intervention arm were 80% more likely to accept (take up pre-ARV care compared to those in the control arm (RR 1.8, 95% CI 1.4-2.1. No adverse events were reported. Conclusions Provision of post-test counseling by staff trained in basic counseling skills, combined with home visits by

Context Specificity of Post-Error and Post-Conflict Cognitive Control Adjustments

Science.gov (United States)

Forster, Sarah E.; Cho, Raymond Y.

2014-01-01

There has been accumulating evidence that cognitive control can be adaptively regulated by monitoring for processing conflict as an index of online control demands. However, it is not yet known whether top-down control mechanisms respond to processing conflict in a manner specific to the operative task context or confer a more generalized benefit. While previous studies have examined the taskset-specificity of conflict adaptation effects, yielding inconsistent results, control-related performance adjustments following errors have been largely overlooked. This gap in the literature underscores recent debate as to whether post-error performance represents a strategic, control-mediated mechanism or a nonstrategic consequence of attentional orienting. In the present study, evidence of generalized control following both high conflict correct trials and errors was explored in a task-switching paradigm. Conflict adaptation effects were not found to generalize across tasksets, despite a shared response set. In contrast, post-error slowing effects were found to extend to the inactive taskset and were predictive of enhanced post-error accuracy. In addition, post-error performance adjustments were found to persist for several trials and across multiple task switches, a finding inconsistent with attentional orienting accounts of post-error slowing. These findings indicate that error-related control adjustments confer a generalized performance benefit and suggest dissociable mechanisms of post-conflict and post-error control. PMID:24603900

Dynamic MRI evaluation of urethral hypermobility post-radical prostatectomy.

Science.gov (United States)

Suskind, Anne M; DeLancey, John O L; Hussain, Hero K; Montgomery, Jeffrey S; Latini, Jerilyn M; Cameron, Anne P

2014-03-01

One postulated cause of post-prostatectomy incontinence is urethral and bladder neck hypermobility. The objective of this study was to determine the magnitude of anatomical differences of urethral and bladder neck position at rest and with valsalva in continent and incontinent men post-prostatectomy based on dynamic MRI. All subjects underwent a dynamic MRI protocol with valsalva and non-valsalva images and a standard urodynamic evaluation. MRI measurements were taken at rest and with valsalva, including (1) bladder neck to sacrococcygeal inferior pubic point line (SCIPP), (2) urethra to pubis, and (3) bulbar urethra to SCIPP. Data were analyzed in SAS using two-tailed t tests. A total of 21 subjects (13 incontinent and 8 continent) had complete data and were included in the final analysis. The two groups had similar demographic characteristics. On MRI, there were no statistically significant differences in anatomic position of the bladder neck or urethra either at rest or with valsalva. The amount of hypermobility ranged from 0.8 to 2 mm in all measures. There were also no differences in the amount of hypermobility (position at rest minus position at valsalva) between groups. We found no statistically significant differences in bladder neck and urethral position or mobility on dynamic MRI evaluation between continent and incontinent men status post-radical prostatectomy. A more complex mechanism for post-prostatectomy incontinence needs to be modeled in order to better understand the continence mechanism in this select group of men. © 2013 Wiley Periodicals, Inc.

Topical sucralfate in post-adenotonsillectomy analgesia in children: a double-blind randomized clinical trial.

Science.gov (United States)

Miura, Mauricio Schreiner; Saleh, Catia; de Andrade, Marina; Assmann, Melina; Ayres, Marcio; Lubianca Neto, José Faibes

2009-09-01

Tonsillectomy, with or without adenoidectomy, is one of the most common surgical procedures in pediatric otolaryngology. Despite its relative simplicity, pain is the main cause of morbidity in the postoperative period. We determined the effect of topical sucralfate on reduction of oropharyngeal pain in children submitted to adenotonsillectomy. Secondary outcomes were otalgia, analgesic use, type of diet, secondary bleeding, vomiting, fever, and weight loss. Double-blind, randomized clinical trial. Tertiary hospital. Eighty-two children of both sexes between four and 12 years old submitted to adenotonsillectomy were evaluated. They were allocated to receive topical sucralfate or placebo in intraoperative and postoperative periods four times a day for five days. Pain was measured through faces pain scale. Reduction in oropharyngeal pain was significant with use of sucralfate during five days of evaluation (mean, 95% confidence interval, and P value); day 1: 2.05, 1.53-2.58, P = 0.000; day 2: 2.1, 1.51-2.70, P = 0.001; day 3: 1.44, 0.88-1.99, P = 0.003; day 4: 1.13, 0.58-1.55, P = 0.027; day 5: 0.67, 0.26-1.04, P = 0.021). There was no difference in secondary outcomes. We found beneficial effect of use of sucralfate in reduction of oropharyngeal pain in the postoperative period of adenotonsillectomy. However, topical sucralfate does not have a potent effect to the point of being utilized as a single analgesic treatment. Because it is simple, safe, tolerated, and low-cost, it is an important tool as adjuvant treatment of post-tonsillectomy pain.

Anti-Vascular Endothelial Growth Factor Comparative Effectiveness Trial for Diabetic Macular Edema: Additional Efficacy Post Hoc Analyses of a Randomized Clinical Trial.

Science.gov (United States)

Jampol, Lee M; Glassman, Adam R; Bressler, Neil M; Wells, John A; Ayala, Allison R

2016-12-01

Post hoc analyses from the Diabetic Retinopathy Clinical Research Network randomized clinical trial comparing aflibercept, bevacizumab, and ranibizumab for diabetic macular edema (DME) might influence interpretation of study results. To provide additional outcomes comparing 3 anti-vascular endothelial growth factor (VEGF) agents for DME. Post hoc analyses performed from May 3, 2016, to June 21, 2016, of a randomized clinical trial performed from August 22, 2012, to September 23, 2015, of 660 participants comparing 3 anti-VEGF treatments in eyes with center-involved DME causing vision impairment. Randomization to intravitreous aflibercept (2.0 mg), bevacizumab (1.25 mg), or ranibizumab (0.3 mg) administered up to monthly based on a structured retreatment regimen. Focal/grid laser treatment was added after 6 months for the treatment of persistent DME. Change in visual acuity (VA) area under the curve and change in central subfield thickness (CST) within subgroups based on whether an eye received laser treatment for DME during the study. Post hoc analyses were performed for 660 participants (mean [SD] age, 61 [10] years; 47% female, 65% white, 16% black or African American, 16% Hispanic, and 3% other). For eyes with an initial VA of 20/50 or worse, VA improvement was greater with aflibercept than the other agents at 1 year but superior only to bevacizumab at 2 years. Mean (SD) letter change in VA over 2 years (area under curve) was greater with aflibercept (+17.1 [9.7]) than with bevacizumab (+12.1 [9.4]; 95% CI, +1.6 to +7.3; P grid laser treatment was performed for DME, the only participants to have a substantial reduction in mean CST between 1 and 2 years were those with a baseline VA of 20/50 or worse receiving bevacizumab and laser treatment (mean [SD], -55 [108] µm; 95% CI, -82 to -28 µm; P grid laser treatment, ceiling and floor effects, or both may account for mean thickness reductions noted only in bevacizumab-treated eyes between 1 and 2 years

A new tool to evaluate postgraduate training posts: the Job Evaluation Survey Tool (JEST).

Science.gov (United States)

Wall, David; Goodyear, Helen; Singh, Baldev; Whitehouse, Andrew; Hughes, Elizabeth; Howes, Jonathan

2014-10-02

Three reports in 2013 about healthcare and patient safety in the UK, namely Berwick, Francis and Keogh have highlighted the need for junior doctors' views about their training experience to be heard. In the UK, the General Medical Council (GMC) quality assures medical training programmes and requires postgraduate deaneries to undertake quality management and monitoring of all training posts in their area. The aim of this study was to develop a simple trainee questionnaire for evaluation of postgraduate training posts based on the GMC, UK standards and to look at the reliability and validity including comparison with a well-established and internationally validated tool, the Postgraduate Hospital Educational Environment Measure (PHEEM). The Job Evaluation Survey Tool (JEST), a fifteen item job evaluation questionnaire was drawn up in 2006, piloted with Foundation doctors (2007), field tested with specialist paediatric registrars (2008) and used over a three year period (2008-11) by Foundation Doctors. Statistical analyses including descriptives, reliability, correlation and factor analysis were undertaken and JEST compared with PHEEM. The JEST had a reliability of 0.91 in the pilot study of 76 Foundation doctors, 0.88 in field testing of 173 Paediatric specialist registrars and 0.91 in three years of general use in foundation training with 3367 doctors completing JEST. Correlation of JEST with PHEEM was 0.80 (p training posts.

Comparing the effect of ketamine and benzydamine gargling with placebo on post-operative sore throat: A randomized controlled trial

Directory of Open Access Journals (Sweden)

Seyed Hamid Reza Faiz

2014-01-01

Full Text Available Background: Air way intubation for general anesthesia usually leads to sore throat after surgery. Ketamine plays an important role to block a number of receptors related to pain. Benzydamine hydrochloride is a non-steroidal anti-inflammatory drug that has been used to improve oropharyngeal disorders. In this study, it was intended to compare the effect of gargling different solutions before the surgery on post-operative sore throat (POST in patients who underwent general anesthesia for hysterectomy. Materials and Methods: A total of 60 patients who underwent the elective hysterectomy were entered to the randomized controlled trial regarding to the eligibility criteria. Patients were simply randomly allocated to three groups and received one code. Every code was representative for a specific drug: 20 cc normal saline (control group or 1.5 mg benzydamine in 20 cc solution or 20 mg ketamine in 20 cc solutions. All the research teams were blinded to the received solutions. POST was evaluated with numerical rating scale. The data were entered to SPSS software and analysis of variance (ANOVA and Kruskal-Wallis one-way analysis of variance test, were performed. Results: The mean ages of ketamine, benzydamine, and normal saline recipients were not significantly different. The trend of the severity of sore throat during the first 24 h after the operation in ketamine recipients was significantly lower than the other two groups (P < 0.001. Conclusion: The pain scale after surgery was reduced by using both ketamine and benzydamine, but the ketamine effect was more noticeable.

Study protocol for the evaluation of an Infant Simulator based program delivered in schools: a pragmatic cluster randomised controlled trial.

Science.gov (United States)

Brinkman, Sally A; Johnson, Sarah E; Lawrence, David; Codde, James P; Hart, Michael B; Straton, Judith A Y; Silburn, Sven

2010-10-21

This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP) program by investigating pre-conceptual health and risk behaviours, teen pregnancy and the resultant birth outcomes, early child health and maternal health. Fifty-seven schools (86% of 66 eligible secondary schools) in Perth, Australia were recruited to the clustered (by school) randomised trial, with even randomisation to the intervention and control arms. Between 2003 and 2006, the VIP program was administered to 1,267 participants in the intervention schools, while 1,567 participants in the non-intervention schools received standard curriculum. Participants were all female and aged between 13-15 years upon recruitment. Pre and post-intervention questionnaires measured short-term impact and participants are now being followed through their teenage years via data linkage to hospital medical records, abortion clinics and education records. Participants who have a live birth are interviewed by face-to-face interview. Kaplan-Meier survival analysis and proportional hazards regression will test for differences in pregnancy, birth and abortion rates during the teenage years between the study arms. This protocol paper provides a detailed overview of the trial design as well as initial results in the form of participant flow. The authors describe the intervention and its delivery within the natural school setting and discuss the practical issues in the conduct of the trial, including recruitment. The trial is pragmatic and will directly inform those who provide Infant Simulator based programs in school settings. ISRCTN24952438.

Indomethacin and diclofenac in the prevention of post-ERCP pancreatitis: a systematic review and meta-analysis of prospective controlled trials.

Science.gov (United States)

Patai, Árpád; Solymosi, Norbert; Mohácsi, László; Patai, Árpád V

2017-06-01

Diclofenac and indomethacin are the most studied drugs for preventing post-ERCP pancreatitis (PEP). However, there are no prospective, randomized multicenter trials with a sufficient number of patients for correct evaluation of their efficacy. Our aim was to evaluate all prospective trials published in full text that studied the efficacy of diclofenac or indomethacin and were controlled with placebo or non-treatment for the prevention of PEP in adult patients undergoing ERCP. Systematic search of databases (PubMed, Scopus, Web of Science, Cochrane) for relevant studies published from inception to 30 June 2016. Our meta-analysis of 4741 patients from 17 trials showed that diclofenac or indomethacin significantly decreased the risk ratio (RR) of PEP to 0.60 (95% confidence interval [CI], 0.46-0.78; P = .0001), number needed to treat (NNT) was 20, and the reduction of RR of moderate to severe PEP was 0.64 (95% CI, 0.43-0.97; P = .0339). The efficacy of indomethacin compared with diclofenac was similar (P = .98). The efficacy of indomethacin or diclofenac did not differ according to timing (P = .99) or between patients with average-risk and high-risk for PEP (P = .6923). The effect of non-rectal administration of indomethacin or diclofenac was not significant (P = .1507), but the rectal route was very effective (P = .0005) with an NNT of 19. The administration of indomethacin or diclofenac was avoided in patients with renal failure. Substantial adverse events were not detected. The use of rectally administered diclofenac or indomethacin before or closely after ERCP is inexpensive and safe and is recommended in every patient (without renal failure) undergoing ERCP. (Registration number: CRD42016042726, http://www.crd.york.ac.uk/prospero/.). Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Cognitive therapy as an early treatment for post-traumatic stress disorder in children and adolescents: a randomized controlled trial addressing preliminary efficacy and mechanisms of action.

Science.gov (United States)

Meiser-Stedman, Richard; Smith, Patrick; McKinnon, Anna; Dixon, Clare; Trickey, David; Ehlers, Anke; Clark, David M; Boyle, Adrian; Watson, Peter; Goodyer, Ian; Dalgleish, Tim

2017-05-01

Few efficacious early treatments for post-traumatic stress disorder (PTSD) in children and adolescents exist. Previous trials have intervened within the first month post-trauma and focused on secondary prevention of later post-traumatic stress; however, considerable natural recovery may still occur up to 6-months post-trauma. No trials have addressed the early treatment of established PTSD (i.e. 2- to 6-months post-trauma). Twenty-nine youth (8-17 years) with PTSD (according to age-appropriate DSM-IV or ICD-10 diagnostic criteria) after a single-event trauma in the previous 2-6 months were randomly allocated to Cognitive Therapy for PTSD (CT-PTSD; n = 14) or waiting list (WL; n = 15) for 10 weeks. Significantly more participants were free of PTSD after CT-PTSD (71%) than WL (27%) at posttreatment (intent-to-treat, 95% CI for difference .04-.71). CT-PTSD yielded greater improvement on child-report questionnaire measures of PTSD, depression and anxiety; clinician-rated functioning; and parent-reported outcomes. Recovery after CT-PTSD was maintained at 6- and 12-month posttreatment. Beneficial effects of CT-PTSD were mediated through changes in appraisals and safety-seeking behaviours, as predicted by cognitive models of PTSD. CT-PTSD was considered acceptable on the basis of low dropout and high treatment credibility and therapist alliance ratings. This trial provides preliminary support for the efficacy and acceptability of CT-PTSD as an early treatment for PTSD in youth. Moreover, the trial did not support the extension of 'watchful waiting' into the 2- to 6-month post-trauma window, as significant improvements in the WL arm (particularly in terms of functioning and depression) were not observed. Replication in larger samples is needed, but attention to recruitment issues will be required. © 2016 The Authors. Journal of Child Psychology and Psychiatry published by John Wiley & Sons Ltd on behalf of Association for Child and Adolescent Mental Health.

Post-traumatic stress disorder in U.S. soldiers with post-traumatic headache.

Science.gov (United States)

Rosenthal, Jacqueline F; Erickson, Jay C

2013-01-01

To determine the impact of post-traumatic stress disorder (PTSD) on headache characteristics and headache prognosis in U.S. soldiers with post-traumatic headache. PTSD and post-concussive headache are common conditions among U.S. Army personnel returning from deployment. The impact of comorbid PTSD on the characteristics and outcomes of post-traumatic headache has not been determined in U.S. Army soldiers. A retrospective cohort study was conducted among 270 consecutive U.S. Army soldiers diagnosed with post-traumatic headache at a single Army neurology clinic. All subjects were screened for PTSD at baseline using the PTSD symptom checklist. Headache frequency and characteristics were determined for post-traumatic headache subjects with and without PTSD at baseline. Headache measures were reassessed 3 months after the baseline visit, and were compared between groups with and without PTSD. Of 270 soldiers with post-traumatic headache, 105 (39%) met screening criteria for PTSD. There was no significant difference between subjects with PTSD and those without PTSD with regard to headache frequency (17.2 vs 15.7 headache days per month; P = .15) or chronic daily headache (58.1% vs 52.1%; P = .34). Comorbid PTSD was associated with higher headache-related disability as measured by the Migraine Disability Assessment Score. Three months after the baseline neurology clinic visit, the number of subjects with at least 50% reduction in headache frequency was similar among post-traumatic headache cases with and without PTSD (25.9% vs 26.8%). PTSD is prevalent among U.S. Army soldiers with post-traumatic headache. Comorbid PTSD is not associated with more frequent headaches or chronic daily headache in soldiers evaluated at a military neurology clinic for chronic post-traumatic headache. Comorbid PTSD does not adversely affect short-term headache outcomes, although prospective controlled trials are needed to better assess this relationship. © 2013 American Headache

Project Rulison: post-shot plans and evaluations

Energy Technology Data Exchange (ETDEWEB)

1969-12-01

Project Rulison post-shot plans and evaluations are discussed and include physical characteristics of the Rulison cavity; pressure and temperature expected in the cavity; amount, nature, and distribution of radioactivity in the cavity; reentry plan; radioactive species which may be encountered during reentry; public safety considerations arising from release of radioactivity; procedures to assure public safety; and the radiological safety plan. Maximum hypothetical accidents and ecological considerations are discussed in the appendices.

Gadobutrol for contrast-enhanced magnetic resonance imaging in elderly patients: review of the safety profile from clinical trial, post-marketing surveillance, and pharmacovigilance data.

Science.gov (United States)

Endrikat, J; Schwenke, C; Prince, M R

2015-07-01

To assess the safety of gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18-64 years. Safety data on gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases. In each dataset, absolute and relative frequencies of ADRs between age groups were analysed, along with odds ratios and 95% confidence intervals. Logistic regression was used to identify significant influencing factors on ADRs in the PMS and pharmacovigilance data. Rates of reported ADRs were lower in elderly patients versus adults aged statistically significant for the clinical trials and pharmacovigilance populations, with a trend in the PMS database. Serious ADRs occurred infrequently in the clinical trials and PMS populations (too low for statistical comparison), and pharmacovigilance data demonstrated a low incidence (<0.005%) in both age groups. This evaluation involving three large databases demonstrated no greater incidence of ADRs following gadobutrol-enhanced MRI in elderly patients (≥65 years) compared with younger adults, with gadobutrol having a favourable safety profile in both age groups. Copyright © 2015 The Royal College of Radiologists. All rights reserved.

COST EVALUATION OF AUTOMATED AND MANUAL POST- CONSUMER PLASTIC BOTTLE SORTING SYSTEMS

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This project evaluates, on the basis of performance and cost, two Automated BottleSort® sorting systems for post-consumer commingled plastic containers developed by Magnetic Separation Systems. This study compares the costs to sort mixed bales of post-consumer plastic at these t...

Tramadol suppositories are less suitable for post-operative pain relief than rectal acetaminophen/codeine

NARCIS (Netherlands)

Pluim, M. A.; Wegener, J. T.; Rupreht, J.; Vulto, A. G.

1999-01-01

The suitability of tramadol suppositories for inclusion in our hospital formulary for the treatment of mild to moderate post-operative pain was evaluated. In an open randomized trial, rectal tramadol was compared with our standard treatment acetaminophen/codeine suppositories. We expected tramadol

A cluster-randomized controlled trial evaluating the effects of delaying onset of adolescent substance abuse on cognitive development and addiction following a selective, personality-targeted intervention programme: the Co-Venture trial.

Science.gov (United States)

O'Leary-Barrett, Maeve; Mâsse, Benoit; Pihl, Robert O; Stewart, Sherry H; Séguin, Jean R; Conrod, Patricia J

2017-10-01

Substance use and binge drinking during early adolescence are associated with neurocognitive abnormalities, mental health problems and an increased risk for future addiction. The trial aims to evaluate the protective effects of an evidence-based substance use prevention programme on the onset of alcohol and drug use in adolescence, as well as on cognitive, mental health and addiction outcomes over 5 years. Thirty-eight high schools will be recruited, with a final sample of 31 schools assigned to intervention or control conditions (3826 youth). Brief personality-targeted interventions will be delivered to high-risk youth attending intervention schools during the first year of the trial. Control school participants will receive no intervention above what is offered to them in the regular curriculum by their respective schools. Public/private French and English high schools in Montreal (Canada). All grade 7 students (12-13 years old) will be invited to participate. High-risk youth will be identified as those scoring one standard deviation or more above the school mean on one of the four personality subscales of the Substance Use Risk Profile Scale (40-45% youth). Self-reported substance use and mental health symptoms and cognitive functioning measured annually throughout 5 years. Primary outcomes are the onset of substance use disorders at 4 years post-intervention (year 5). Secondary intermediate outcomes are the onset of alcohol and substance use 2 years post-intervention and neuropsychological functions; namely, the protective effects of substance use prevention on cognitive functions generally, and executive functions and reward sensitivity specifically. This longitudinal, cluster-randomized controlled trial will investigate the impact of a brief personality-targeted intervention program on reducing the onset of addiction 4 years-post intervention. Results will tease apart the developmental sequences of uptake and growth in substance use and cognitive

Piracetam for Aphasia in Post-stroke Patients: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

Science.gov (United States)

Zhang, Jie; Wei, Ruili; Chen, Zhongqin; Luo, Benyan

2016-07-01

Aphasia is a common symptom in post-stroke patients. Piracetam is a commonly used nootropic agent that promises various benefits to brain function, including language improvement. We performed a systematic review and meta-analysis to assess whether piracetam facilitates the rehabilitation of language performance in post-stroke patients. Randomized controlled trials (RCTs) of piracetam treatment in post-stroke patients published in any language were included, excluding those involving pre-existing cognitive disorders such as dementia and mood disturbances. We searched several databases including PubMed, EMBASE, Cochrane Central, CINAHL, Web of Science, and PsycINFO for RCTs published up to 31 December 2015. We conducted a meta-analysis using RevMan (version 5.3), with standardized mean differences (SMDs) and fixed-effect models, and used StataSE (version 13) for the detection of publication bias. This study has been submitted to PROSPERO, and its registration number is CRD42016034088. We identified 1180 titles and abstracts, and finally included seven RCTs in this meta-analysis. The number of participants in each study ranged from 19 to 66, summing up to 261 patients overall. The dose of piracetam was consistent while the frequency and time of therapy varied. The assessment of the language at the end of trials showed no significant improvement in overall severity of aphasia [SMD 0.23, 95 % confidence interval (CI) -0.03 to 0.49, P = 0.08], but written language (SMD 0.35, 95 % CI 0.04 to 0.66, P = 0.03) showed pronounced improvement. Subgroup analyses indicated a dissociation of effectiveness between short- and long-term assessment in overall severity (P = 0.008, I (2) = 85.6 %) in terms of tests for subgroup differences, and a mild trend toward dissociation in written subtests (P = 0.30, I (2) = 5.1 %). Funnel plots and Egger's test identified no obvious publication bias in the primary variable. Piracetam plays a limited role in the rehabilitation of

Study protocol for the evaluation of an Infant Simulator based program delivered in schools: a pragmatic cluster randomised controlled trial

Directory of Open Access Journals (Sweden)

Hart Michael B

2010-10-01

Full Text Available Abstract Background This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP program by investigating pre-conceptual health and risk behaviours, teen pregnancy and the resultant birth outcomes, early child health and maternal health. Methods and Design Fifty-seven schools (86% of 66 eligible secondary schools in Perth, Australia were recruited to the clustered (by school randomised trial, with even randomisation to the intervention and control arms. Between 2003 and 2006, the VIP program was administered to 1,267 participants in the intervention schools, while 1,567 participants in the non-intervention schools received standard curriculum. Participants were all female and aged between 13-15 years upon recruitment. Pre and post-intervention questionnaires measured short-term impact and participants are now being followed through their teenage years via data linkage to hospital medical records, abortion clinics and education records. Participants who have a live birth are interviewed by face-to-face interview. Kaplan-Meier survival analysis and proportional hazards regression will test for differences in pregnancy, birth and abortion rates during the teenage years between the study arms. Discussion This protocol paper provides a detailed overview of the trial design as well as initial results in the form of participant flow. The authors describe the intervention and its delivery within the natural school setting and discuss the practical issues in the conduct of the trial, including recruitment. The trial is pragmatic and will directly inform those who provide

The Correction of Myopia Evaluation Trial: lessons from the study design.

Science.gov (United States)

Hyman, L; Gwiazda, J

2004-01-01

The Correction of Myopia Evaluation Trial (COMET), a multicentre clinical trial based in 4 schools of optometry in the United States, evaluated the effect of progressive addition lenses versus single vision lenses on myopia progression in an ethnically diverse group of 469 myopic children aged 6 to 11 years. Completion of the clinical trial phase of the study provides an opportunity to evaluate aspects of the study design that contribute to its success. This article describes aspects of the study design that were influential in ensuring the smooth conduct of COMET. These include a dedicated team of investigators, an organisational structure with strong leadership and an independent Co-ordinating Centre, regular communication among investigators, flexible and creative approaches to recruitment and retention, sensitivity to concerns for child safety and child participation, and methods for enhancing and monitoring data reliability. The experience with COMET has provided a number of valuable lessons for all aspects of the study design that should benefit the development and implementation of future clinical trials, particularly those done in similar populations of children. The use of a carefully designed protocol using standard methods by dedicated members of the study team is essential in ensuring achievement of the study aims.

Evaluating a multicomponent social behaviour change communication strategy to reduce intimate partner violence among married couples: study protocol for a cluster randomized trial in Nepal

Directory of Open Access Journals (Sweden)

Cari Jo Clark

2017-01-01

Full Text Available Abstract Background Intimate partner violence (IPV is a significant public health issue that affects 1 in 3 women globally and a similarly large number of women in Nepal. Over the past decade, important policy and programmatic steps have been taken to address violence against women in Nepal. There remains a dearth of evidence on the effectiveness of primary violence prevention strategies. The Change Starts at Home study begins to fill this gap by utilizing a multi-component social behaviour change communication (SBCC strategy involving a radio drama and community mobilization to shift attitudes, norms and behaviours that underpin IPV perpetration in Nepal. Methods/Design The study uses a concurrent mixed-methods design. The quantitative aspect of the evaluation is a pair-matched, repeated cross-sectional 2-armed, single-blinded cluster trial (RCT: N = 36 clusters, 1440 individuals, comparing a social behaviour change communication (SBCC strategy to radio programming alone for its impact on physical and / or sexual IPV at the end of programming (12 months’ post-baseline and 6-months post the cessation of project activities (18-months post baseline. The qualitative aspects of the design include several longitudinal approaches to understand the impact of the intervention and to examine mechanisms of change including in-depth interviews with participants (N = 18 couples, and focus group discussions with community leaders (N = 3 groups, and family members of participants (N = 12 groups. Treatment effects will be estimated with generalized logistic mixed models specified to compare differences in primary outcome from baseline to 12-month follow-up, and baseline to 18-months follow-up in accordance with intention-to-treat principles. Discussion The study rigorously evaluates the effectiveness of a promising strategy to prevent IPV. The results of the trial will be immediately useful for governmental, nongovernmental, and donor funded

Impact of School-Based HIV Prevention Program in Post-Conflict Liberia

Science.gov (United States)

Atwood, Katharine A.; Kennedy, Stephen B.; Shamblen, Steve; Tegli, Jemee; Garber, Salome; Fahnbulleh, Pearl W.; Korvah, Prince M.; Kolubah, Moses; Mulbah-Kamara, Comfort; Fulton, Shannon

2012-01-01

This paper presents findings of a feasibility study to adapt and evaluate the impact of an evidence-based HIV prevention intervention on sexual risk behaviors of in-school 6th grade youth in post-conflict Liberia (n = 812). The study used an attention-matched, group randomized controlled trial. Four matched pairs of elementary/middle schools in…

Evaluation of human health risk from in situ recovery uranium mining, pre-and post-mining, and post-restoration

Energy Technology Data Exchange (ETDEWEB)

Ruedig, E.; Bhattacharyya, A.; Borch, T.; Johnson, T. [Colorado State University (United States); Till, J. [Risk Assessment Corporation (United States)

2014-07-01

In the United States, the restoration of in situ recovery (ISR) uranium mines is aimed at returning sites to pre-mining conditions. While this may seem an appropriate goal, little or no scientific information is available to justify utilizing baseline conditions for regulatory compliance. The chemical and radiological contaminants monitored for restoration compliance have not been evaluated to ensure they are proper indicators of the mitigation of risk. Pre-mining aquifers do not meet minimum United States drinking water standards, and must have an aquifer exemption in place prior to mining. Under these conditions, returning groundwater to near the original concentrations of contaminants may be unnecessary. Post-mining groundwater is also unlikely to meet standards for drinking water, but may be depleted in at least some toxic species as a result of the mining process. Here, we examine the risk to representative person from the personal use of groundwater sourced from an Uranium ISR mine. Water samples were collected from Cameco Resource's Smith Ranch-Highlands ISR Uranium mine near Casper, Wyoming, USA. Samples were acquired pre-mining, post-mining, and post-restoration. Concentrations of heavy metals and radionuclides were assessed by appropriate analytical techniques (e.g., mass spectroscopy or alpha spectroscopy) and these concentrations were used to estimate human health risk for three exposure scenarios: a scenario with high exposure, a scenario with medium exposure, and a scenario with low exposure. A simple biosphere transport model was constructed for each scenario to estimate the risk to humans from the use of contaminated waters for subsistence-related activities. Chemical and radiological risks were harmonized according to the United States Environmental Protection Agency's guidance for superfund sites. Each exposure scenario and its subsequent risk were evaluated individually for pre-mining, post-mining, and post-restoration aquifer waters

The impact of early outcome events on the effect of tranexamic acid in post-partum haemorrhage: an exploratory subgroup analysis of the WOMAN trial.

Science.gov (United States)

Brenner, Amy; Shakur-Still, Haleema; Chaudhri, Rizwana; Fawole, Bukola; Arulkumaran, Sabaratnam; Roberts, Ian

2018-06-07

In severe post-partum haemorrhage, death can occur within hours of bleeding onset so interventions to control the bleeding must be given immediately. In clinical trials of treatments for life-threatening bleeding, established treatments are given priority and the trial treatment is usually given last. However, enrolling patients in whom severe maternal morbidity or death is imminent or inevitable at the time of randomisation may dilute the effects of a trial treatment. We conducted an exploratory analysis of data from the WOMAN trial, an international, randomised placebo-controlled trial of the effects of tranexamic acid on death and surgical intervention in 20,060 women with post-partum haemorrhage. We assessed the impact of early maternal death or hysterectomy due to exsanguination on the effect of tranexamic acid on each of these respective outcomes. We conducted repeated analyses excluding patients with these outcomes at increasing intervals from the time of randomisation. We quantified treatment effects using risk ratios (RR) and 99% confidence intervals (CI) and prepared cumulative failure plots. Among 14,923 women randomised within 3 h of delivery (7518 tranexamic acid and 7405 placebo), there were 216 bleeding deaths (1.5%) and 383 hysterectomies due to bleeding (2.8%). After excluding deaths from exsanguination at increasing time intervals following randomization, there was a significant reduction in the risk of death due to bleeding with tranexamic acid (RR = 0.41; 99% CI 0.19-0.89). However, after excluding hysterectomies at increasing time intervals post-randomization, there was no reduction in the risk of hysterectomy due to bleeding with tranexamic acid (RR = 0.79; 99% CI 0.33-1.86). Findings from this analysis provide further evidence that tranexamic acid reduces the risk of death from exsanguination in women who experience postpartum haemorrhage. It is uncertain whether tranexamic acid reduces the risk of hysterectomy for bleeding after

A Smartphone App (BlueIce) for Young People Who Self-Harm: Open Phase 1 Pre-Post Trial

Science.gov (United States)

Porter, Joanna; Grist, Rebecca

2018-01-01

Background Recent years have seen a significant increase in the availability of smartphone apps for mental health problems. Despite their proliferation, few apps have been specifically developed for young people, and almost none have been subject to any form of evaluation. Objective This study aimed to undertake a preliminary evaluation of a smartphone app (BlueIce), coproduced with young people and designed to help young people manage distress and urges to self-harm. We aimed to assess the acceptability, safety, and use of BlueIce and to explore the effects on the primary outcome of self-harm and the secondary outcomes of psychological functioning. Methods We undertook an open trial where we recruited young people aged 12 to 17 years attending specialist child and adolescent mental health services (CAMHS) who were currently self-harming or had a history of self-harm. Eligible participants were assessed at baseline and then given BlueIce. They were assessed 2 weeks later (post familiarization) and again at 12 weeks (post use). A behavior-screening questionnaire (Strengths and Difficulties Questionnaire) was completed along with standardized measures of depression (Mood and Feelings Questionnaire or MFQ) and anxiety (Revised Child Anxiety and Depression Scale or RCADS), taking into account self-reports of self-harm, app helpfulness, and safety. Results All core CAMHS professional groups referred at least 1 young person. Out of 40 young people recruited, 37 (93%) elected to use BlueIce after familiarization, with 29 out of 33 (88%) wanting to keep it at the end of the study. No young person called the emergency numbers during the 12-week trial, and no one was withdrawn by his or her clinician due to increased risk of suicide. Almost three-quarters (73%) of those who had recently self-harmed reported reductions in self-harm after using BlueIce for 12 weeks. There was a statistically significant mean difference of 4.91 (t31=2.11; P=.04; 95% CI 0.17-9.64) on postuse

Relationship between post-extraction pain and acute pulpitis: a randomised trial using third molars.

Science.gov (United States)

Zhang, Wei; Dai, Yong-Bo; Wan, Peng-Cheng; Xu, Dong-Dong; Guo, Yi; Li, Zhi

2016-12-01

The aim of the present study was to examine the relationship between post-extraction pain and acute pulpitis in third molars. This study was a randomised controlled trial. Sixty patients requiring removal of a single maxillary third molar with acute pulpitis were included and randomly divided into two groups: group A (n = 30); and group B (n = 30). In group A, third molars were directly extracted, and group B received endodontic therapy (pulp chamber opening and drainage) and underwent extraction 24 hours later, aiming to eliminate the acute inflammation. Another 30 patients requiring removal of a single maxillary third molar and with the same inclusion criteria but without caries or acute pulpitis were recruited into group C, in which the maxillary third molars were also directly extracted. The level of postoperative pain reported each day among the three groups was statistically evaluated. On the first, second and third days after surgery, there was a statistically significant difference between group A and group B and between group A and group C, but there was no statistically significant difference between group B and group C. The results of the present study indicate that there is more pain when third molars with acute pulpitis are directly removed compared with the pain level of the removal of third molars without acute pulpitis. © 2016 FDI World Dental Federation.

Effect of β-alanine supplementation on 20 km cycling time trial performance

Directory of Open Access Journals (Sweden)

Ruth Margaret JAMES

2014-09-01

Full Text Available The effects of β-alanine supplementation on high-intensity cycling performance and capacity have been evaluated, although the effects on longer duration cycling performance are unclear. Nineteen UK category 1 male cyclists completed four 20 km cycling time trials, two before and two after supplementation with either 6.4 g•d-1 β-alanine (n = 10; BA or a matched placebo (n = 9; P. Performance time for the 20 km time trial and 1 km split times were recorded. There was no significant effect of β-alanine supplementation on 20 km time trial performance (BA-pre 1943 ± 129 s; BA-post 1950 ± 147 s; P-pre 1989 ± 106 s; P-post 1986 ± 115 s or on the performance of each 1 km split. The effect of β-alanine on 20 km time trial performance was deemed unclear as determined by magnitude based inferences. Supplementation with 6.4 g•d-1 of β-alanine for 4 weeks did not affect 20 km cycling time trial performance in well trained male cyclists.

A process evaluation of the Supermarket Healthy Eating for Life (SHELf) randomized controlled trial.

Science.gov (United States)

Olstad, Dana Lee; Ball, Kylie; Abbott, Gavin; McNaughton, Sarah A; Le, Ha N D; Ni Mhurchu, Cliona; Pollard, Christina; Crawford, David A

2016-02-24

Supermarket Healthy Eating for Life (SHELf) was a randomized controlled trial that operationalized a socioecological approach to population-level dietary behaviour change in a real-world supermarket setting. SHELf tested the impact of individual (skill-building), environmental (20% price reductions), and combined (skill-building + 20% price reductions) interventions on women's purchasing and consumption of fruits, vegetables, low-calorie carbonated beverages and water. This process evaluation investigated the reach, effectiveness, implementation, and maintenance of the SHELf interventions. RE-AIM provided a conceptual framework to examine the processes underlying the impact of the interventions using data from participant surveys and objective sales data collected at baseline, post-intervention (3 months) and 6-months post-intervention. Fisher's exact, χ (2) and t-tests assessed differences in quantitative survey responses among groups. Adjusted linear regression examined the impact of self-reported intervention dose on food purchasing and consumption outcomes. Thematic analysis identified key themes within qualitative survey responses. Reach of the SHELf interventions to disadvantaged groups, and beyond study participants themselves, was moderate. Just over one-third of intervention participants indicated that the interventions were effective in changing the way they bought, cooked or consumed food (p < 0.001 compared to control), with no differences among intervention groups. Improvements in purchasing and consumption outcomes were greatest among those who received a higher intervention dose. Most notably, participants who said they accessed price reductions on fruits and vegetables purchased (519 g/week) and consumed (0.5 servings/day) more vegetables. The majority of participants said they accessed (82%) and appreciated discounts on fruits and vegetables, while there was limited use (40%) and appreciation of discounts on low-calorie carbonated

Live-attenuated tetravalent dengue vaccines: The needs and challenges of post-licensure evaluation of vaccine safety and effectiveness.

Science.gov (United States)

Wichmann, Ole; Vannice, Kirsten; Asturias, Edwin J; de Albuquerque Luna, Expedito José; Longini, Ira; Lopez, Anna Lena; Smith, Peter G; Tissera, Hasitha; Yoon, In-Kyu; Hombach, Joachim

2017-10-09

Since December 2015, the first dengue vaccine has been licensed in several Asian and Latin American countries for protection against disease from all four dengue virus serotypes. While the vaccine demonstrated an overall good safety and efficacy profile in clinical trials, some key research questions remain which make risk-benefit-assessment for some populations difficult. As for any new vaccine, several questions, such as very rare adverse events following immunization, duration of vaccine-induced protection and effectiveness when used in public health programs, will be addressed by post-licensure studies and by data from national surveillance systems after the vaccine has been introduced. However, the complexity of dengue epidemiology, pathogenesis and population immunity, as well as some characteristics of the currently licensed vaccine, and potentially also future, live-attenuated dengue vaccines, poses a challenge for evaluation through existing monitoring systems, especially in low and middle-income countries. Most notable are the different efficacies of the currently licensed vaccine by dengue serostatus at time of first vaccination and by dengue virus serotype, as well as the increased risk of dengue hospitalization among young vaccinated children observed three years after the start of vaccination in one of the trials. Currently, it is unknown if the last phenomenon is restricted to younger ages or could affect also seronegative individuals aged 9years and older, who are included in the group for whom the vaccine has been licensed. In this paper, we summarize scientific and methodological considerations for public health surveillance and targeted post-licensure studies to address some key research questions related to live-attenuated dengue vaccines. Countries intending to introduce a dengue vaccine should assess their capacities to monitor and evaluate the vaccine's effectiveness and safety and, where appropriate and possible, enhance their surveillance

Efficacy of Mindfulness-Based Cognitive Therapy on Late Post-Treatment Pain in Women Treated for Primary Breast Cancer: A Randomized Controlled Trial

DEFF Research Database (Denmark)

Johannsen, Maja; O Connor, Maja; OToole, Mia Skytte

2016-01-01

PURPOSE: To assess the efficacy of mindfulness-based cognitive therapy (MBCT) for late post-treatment pain in women treated for primary breast cancer. METHODS: A randomized wait list-controlled trial was conducted with 129 women treated for breast cancer reporting post-treatment pain (score ≥ 3...... pain rehabilitation strategy for women treated for breast cancer. In addition, the effect on neuropathic pain, a pain type reported by women treated for breast cancer, further suggests the potential of MBCT but should be considered preliminary....

Post-Exercise Protein Trial: Interactions between Diet and Exercise (PEPTIDE): study protocol for randomized controlled trial.

Science.gov (United States)

Alghannam, Abdullah F; Tsintzas, Kostas; Thompson, Dylan; Bilzon, James; Betts, James A

2014-11-24

Performing regular exercise is known to manifest a number of health benefits that mainly relate to cardiovascular and muscular adaptations to allow for greater oxygen extraction and utilization. There is increasing evidence that nutrient intake can affect the adaptive response to a single exercise bout, and that protein feeding is important to facilitate this process. Thus, the exercise-nutrient interaction may potentially lead to a greater response to training. The role of post-exercise protein ingestion in enhancing the effects of running-based endurance exercise training relative to energy-matched carbohydrate intervention remains to be established. Additionally, the influence of immediate versus overnight protein ingestion in mediating these training effects is currently unknown. The current protocol aims to establish whether post-exercise nutrient intake and timing would influence the magnitude of improvements during a prescribed endurance training program. The project involves two phases with each involving two treatment arms applied in a randomized investigator-participant double-blind parallel group design. For each treatment, participants will be required to undergo six weeks of running-based endurance training. Immediately post-exercise, participants will be prescribed solutions providing 0.4 grams per kilogram of body mass (g · kg(-1)) of whey protein hydrolysate plus 0.4 g · kg(-1) sucrose, relative to an isocaloric sucrose control (0.8 g · kg(-1); Phase I). In Phase II, identical protein supplements will be provided (0.4 + 0.4 g · kg(-1) · h(-1) of whey protein hydrolysate and sucrose, respectively), with the timing of ingestion manipulated to compare immediate versus overnight recovery feedings. Anthropometric, expired gas, venous blood and muscle biopsy samples will be obtained at baseline and following the six-week training period. By investigating the role of nutrition in enhancing the effects of endurance exercise training, we will provide

Confirmatory factor analysis of Post-Occupancy Evaluation Model (POEM) for sustainable neighborhood development

Science.gov (United States)

Yaman, R.; Thadaniti, S.; Abdullah, J.; Ahmad, N.; Ishak, N. M.

2018-02-01

The sustainable urban development growth in the ASEAN region has accelerated tremendously. More demand on the sustainable development has led to bigger market driven certified green neighborhood and buildings. However, there is a lack of post-occupancy evaluation study conducted in assessing the end-users perspective on the certified sustainable neighborhood development. This paper aims to investigate the end-users point of view on sustainable dimension pillar (SDP) adaptation based on environment dimension, social dimension and economic dimension using Post-Occupancy Evaluation Model (POEM) framework. The research methodology employed stakeholders-Inclusion Approach survey questionnaires in order to obtained the sustainable dimensional adaptation score. The results show that there is sustainable dimension gap in POEM evaluation, hence, suggested the pre- occupancy criteria did not fulfill the SDP adaptation and pre-occupancy criteria and variables if differ from post-occupancy criteria and variables.

Hypothermia after cardiac arrest should be further evaluated-A systematic review of randomised trials with meta-analysis and trial sequential analysis

DEFF Research Database (Denmark)

Nielsen, Niklas; Friberg, Hans; Gluud, Christian

2011-01-01

BACKGROUND: Guidelines recommend mild induced hypothermia (MIH) to reduce mortality and neurological impairment after out-of-hospital cardiac arrest. Our objective was to systematically evaluate the evidence for MIH taking into consideration the risks of systematic and random error and to GRADE...... the evidence. METHODS: Systematic review with meta-analysis and trial sequential analysis of randomised trials evaluating MIH after cardiac arrest in adults. We searched CENTRAL, MEDLINE, and EMBASE databases until May 2009. Retrieved trials were evaluated with Cochrane methodology. Meta-analytic estimates....... The substantial risk of bias and concerns with directness rated down the quality of the evidence to low. CONCLUSIONS: Evidence regarding MIH after out-of-hospital cardiac arrest is still inconclusive and associated with non-negligible risks of systematic and random errors. Using GRADE-methodology, we conclude...

Cost-utility analysis of a one-time supervisor telephone contact at 6-weeks post-partum to prevent extended sick leave following maternity leave in The Netherlands: results of an economic evaluation alongside a randomized controlled trial

Directory of Open Access Journals (Sweden)

van Poppel Mireille NM

2011-01-01

Full Text Available Abstract Background Working women of childbearing age are a vital part of the population. Following childbirth, this group of women can experience a myriad of physical and mental health problems that can interfere with their ability to work. Currently, there is little known about cost-effective post-partum interventions to prevent work disability. The purpose of the study was to evaluate whether supervisor telephone contact (STC during maternity leave is cost-effective from a societal perspective in reducing sick leave and improving quality-adjusted life years (QALYs compared to common practice (CP. Methods We conducted an economic evaluation alongside a randomized controlled trial. QALYs were measured by the EuroQol 5-D, and sick leave and presenteeism by the Health and work Performance Questionnaire. Resource use was collected by questionnaires. Data were analysed according to intention-to-treat. Missing data were imputed via multiple imputation. Uncertainty was estimated by 95% confidence intervals, cost-utility planes and curves, and sensitivity analyses. Results 541 working women from 15 companies participated. Response rates were above 85% at each measurement moment. At the end of the follow-up, no statistically significant between-group differences in QALYs, mean hours of sick leave or presenteeism or costs were observed. STC was found to be less effective and more costly. For willingness-to-pay levels from €0 through €50,000, the probability that STC was cost-effective compared to CP was 0.2. Overall resource use was low. Mean total costs were €3678 (95% CI: 3386; 3951. Productivity loss costs represented 37% of the total costs and of these costs, 48% was attributable to sick leave and 52% to work presenteeism. The cost analysis from a company's perspective indicated that there was a net cost associated with the STC intervention. Conclusions STC was not cost-effective compared to common practice for a healthy population of working

Australasian Resuscitation In Sepsis Evaluation trial statistical analysis plan.

Science.gov (United States)

Delaney, Anthony; Peake, Sandra L; Bellomo, Rinaldo; Cameron, Peter; Holdgate, Anna; Howe, Belinda; Higgins, Alisa; Presneill, Jeffrey; Webb, Steve

2013-10-01

The Australasian Resuscitation In Sepsis Evaluation (ARISE) study is an international, multicentre, randomised, controlled trial designed to evaluate the effectiveness of early goal-directed therapy compared with standard care for patients presenting to the ED with severe sepsis. In keeping with current practice, and taking into considerations aspects of trial design and reporting specific to non-pharmacologic interventions, this document outlines the principles and methods for analysing and reporting the trial results. The document is prepared prior to completion of recruitment into the ARISE study, without knowledge of the results of the interim analysis conducted by the data safety and monitoring committee and prior to completion of the two related international studies. The statistical analysis plan was designed by the ARISE chief investigators, and reviewed and approved by the ARISE steering committee. The data collected by the research team as specified in the study protocol, and detailed in the study case report form were reviewed. Information related to baseline characteristics, characteristics of delivery of the trial interventions, details of resuscitation and other related therapies, and other relevant data are described with appropriate comparisons between groups. The primary, secondary and tertiary outcomes for the study are defined, with description of the planned statistical analyses. A statistical analysis plan was developed, along with a trial profile, mock-up tables and figures. A plan for presenting baseline characteristics, microbiological and antibiotic therapy, details of the interventions, processes of care and concomitant therapies, along with adverse events are described. The primary, secondary and tertiary outcomes are described along with identification of subgroups to be analysed. A statistical analysis plan for the ARISE study has been developed, and is available in the public domain, prior to the completion of recruitment into the

Post Landsat-D advanced concept evaluation /PLACE/

Science.gov (United States)

Alexander, L. D.; Alvarado, U. R.; Flatow, F. S.

1979-01-01

The aim of the Post Landsat-D Advanced Concept Evaluation (PLACE) program was to identify the key technology requirements of earth resources satellite systems for the 1985-2000 period. The program involved four efforts: (1) examination of future needs in the earth resources area, (2) creation of a space systems technology model capable of satisfying these needs, (3) identification of key technology requirements posed by this model, and (4) development of a methodology (PRISM) to assist in the priority structuring of the resulting technologies.

Conducting field trials for frost tolerance breeding in cereals.

Science.gov (United States)

Cattivelli, Luigi

2014-01-01

Cereal species can be damaged by frost either during winter or at flowering stage. Frost tolerance per se is only a part of the mechanisms that allow the plants to survive during winter; winterhardiness also considers other biotic or physical stresses that challenge the plants during the winter season limiting their survival rate. While frost tolerance can also be tested in controlled environments, winterhardiness can be determined only with field evaluations. Post-heading frost damage occurs from radiation frost events in spring during the reproductive stages. A reliable evaluation of winterhardiness or of post-heading frost damage should be carried out with field trials replicated across years and locations to overcome the irregular occurrence of natural conditions which satisfactorily differentiate genotypes. The evaluation of post-heading frost damage requires a specific attention to plant phenology. The extent of frost damage is usually determined with a visual score at the end of the winter.

Evaluating post-wildfire hydrologic recovery using ParFlow in southern California

Science.gov (United States)

Lopez, S. R.; Kinoshita, A. M.; Atchley, A. L.

2016-12-01

Wildfires are naturally occurring hazards that can have catastrophic impacts. They can alter the natural processes within a watershed, such as surface runoff and subsurface water storage. Generally, post-fire hydrologic models are either one-dimensional, empirically-based models, or two-dimensional, conceptually-based models with lumped parameter distributions. These models are useful in providing runoff measurements at the watershed outlet; however, do not provide distributed hydrologic simulation at each point within the watershed. This research demonstrates how ParFlow, a three-dimensional, distributed hydrologic model can simulate post-fire hydrologic processes by representing soil burn severity (via hydrophobicity) and vegetation recovery as they vary both spatially and temporally. Using this approach, we are able to evaluate the change in post-fire water components (surface flow, lateral flow, baseflow, and evapotranspiration). This model is initially developed for a hillslope in Devil Canyon, burned in 2003 by the Old Fire in southern California (USA). The domain uses a 2m-cell size resolution over a 25 m by 25 m lateral extent. The subsurface reaches 2 m and is assigned a variable cell thickness, allowing an explicit consideration of the soil burn severity throughout the stages of recovery and vegetation regrowth. Vegetation regrowth is incorporated represented by satellite-based Enhanced Vegetation Index (EVI) products. The pre- and post-fire surface runoff, subsurface storage, and surface storage interactions are evaluated and will be used as a basis for developing a watershed-scale model. Long-term continuous simulations will advance our understanding of post-fire hydrological partitioning between water balance components and the spatial variability of watershed processes, providing improved guidance for post-fire watershed management.

A randomized clinical trial of buprenorphine for prisoners: Findings at 12-months post-release.

Science.gov (United States)

Gordon, Michael S; Kinlock, Timothy W; Schwartz, Robert P; O'Grady, Kevin E; Fitzgerald, Terrence T; Vocci, Frank J

2017-03-01

This study examined whether starting buprenorphine treatment prior to prison and after release from prison would be associated with better drug treatment outcomes and whether males and females responded differently to the combination of in-prison treatment and post-release service setting. Study design was a 2 (In-Prison Treatment: Condition: Buprenorphine Treatment: vs. Counseling Only)×2 [Post-Release Service Setting Condition: Opioid Treatment: Program (OTP) vs. Community Health Center (CHC)]×2 (Gender) factorial design. The trial was conducted between September 2008 and July 2012. Follow-up assessments were completed in 2014. Participants were recruited from two Baltimore pre-release prisons (one for men and one for women). Adult pre-release prisoners who were heroin-dependent during the year prior to incarceration were eligible. Post-release assessments were conducted at 1, 3, 6, and 12-month following prison release. Participants (N=211) in the in-prison treatment condition effect had a higher mean number of days of community buprenorphine treatment compared to the condition in which participants initiated medication after release (P=0.005). However, there were no statistically significant hypothesized effects for the in-prison treatment condition in terms of: days of heroin use and crime, and opioid and cocaine positive urine screening test results (all Ps>0.14) and no statistically significant hypothesized gender effects (all Ps>0.18). Although initiating buprenorphine treatment in prison compared to after-release was associated with more days receiving buprenorphine treatment in the designated community treatment program during the 12-months post-release assessment, it was not associated with superior outcomes in terms of heroin and cocaine use and criminal behavior. Copyright © 2017 Elsevier B.V. All rights reserved.

The intervention process in the European Fans in Training (EuroFIT) trial: a mixed method protocol for evaluation.

Science.gov (United States)

van de Glind, I; Bunn, C; Gray, C M; Hunt, K; Andersen, E; Jelsma, J; Morgan, H; Pereira, H; Roberts, G; Rooksby, J; Røynesdal, Ø; Silva, M; Sorensen, M; Treweek, S; van Achterberg, T; van der Ploeg, H; van Nassau, F; Nijhuis-van der Sanden, M; Wyke, S

2017-07-27

EuroFIT is a gender-sensitised, health and lifestyle program targeting physical activity, sedentary time and dietary behaviours in men. The delivery of the program in football clubs, led by the clubs' community coaches, is designed to both attract and engage men in lifestyle change through an interest in football or loyalty to the club they support. The EuroFIT program will be evaluated in a multicentre pragmatic randomised controlled trial (RCT), for which ~1000 overweight men, aged 30-65 years, will be recruited in 15 top professional football clubs in the Netherlands, Norway, Portugal and the UK. The process evaluation is designed to investigate how implementation within the RCT is achieved in the various football clubs and countries and the processes through which EuroFIT affects outcomes. This mixed methods evaluation is guided by the Medical Research Council (MRC) guidance for conducting process evaluations of complex interventions. Data will be collected in the intervention arm of the EuroFIT trial through: participant questionnaires (n = 500); attendance sheets and coach logs (n = 360); observations of sessions (n = 30); coach questionnaires (n = 30); usage logs from a novel device for self-monitoring physical activity and non-sedentary behaviour (SitFIT); an app-based game to promote social support for physical activity outside program sessions (MatchFIT); interviews with coaches (n = 15); football club representatives (n = 15); and focus groups with participants (n = 30). Written standard operating procedures are used to ensure quality and consistency in data collection and analysis across the participating countries. Data will be analysed thematically within datasets and overall synthesis of findings will address the processes through which the program is implemented in various countries and clubs and through which it affects outcomes, with careful attention to the context of the football club. The process evaluation will

The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records : evaluations of two exemplar trials

NARCIS (Netherlands)

van Staa, Tjeerd-Pieter; Dyson, Lisa; McCann, Gerard; Padmanabhan, Shivani; Belatri, Rabah; Goldacre, Ben; Cassell, Jackie; Pirmohamed, Munir; Torgerson, David; Ronaldson, Sarah; Adamson, Joy; Taweel, Adel; Delaney, Brendan; Mahmood, Samhar; Baracaia, Simona; Round, Thomas; Fox, Robin; Hunter, Tommy; Gulliford, Martin; Smeeth, Liam

BACKGROUND: Pragmatic trials compare the effects of different decisions in usual clinical practice. OBJECTIVES: To develop and evaluate methods to implement simple pragmatic trials using routinely collected electronic health records (EHRs) and recruiting patients at the point of care; to identify

Comparison of peritonsillar infiltration effects of ketamine and tramadol on post tonsillectomy pain: a double-blinded randomized placebo-controlled clinical trial

Science.gov (United States)

Ayatollahi, Vida; Behdad, Shekoufeh; Hatami, Maryam; Moshtaghiun, Hossein; Baghianimoghadam, Behnam

2012-01-01

Aim To assess the effect of peritonsillar infiltration of ketamine and tramadol on post tonsillectomy pain and compare the side effects. Methods The double-blind randomized clinical trial was performed on 126 patients aged 5-12 years who had been scheduled for elective tonsillectomy. The patients were randomly divided into 3 groups to receive either ketamine, tramadol, or placebo. They had American Society of Anesthesiologists physical status class I and II. All patients underwent the same method of anesthesia and surgical procedure. The three groups did not differ according to their age, sex, and duration of anesthesia and surgery. Post operative pain was evaluated using CHEOPS score. Other parameters such as the time to the first request for analgesic, hemodynamic elements, sedation score, nausea, vomiting, and hallucination were also assessed during 12 hours after surgery. Results Tramadol group had significantly lower pain scores (P = 0.005), significantly longer time to the first request for analgesic (P = 0.001), significantly shorter time to the beginning of liquid regimen (P = 0.001), and lower hemodynamic parameters such as blood pressure (P = 0.001) and heart rate (P = 0.001) than other two groups. Ketamine group had significantly greater presence of hallucinations and negative behavior than tramadol and placebo groups. The groups did not differ significantly in the presence of nausea and vomiting. Conclusion Preoperative peritonsillar infiltration of tramadol can decrease post-tonsillectomy pain, analgesic consumption, and the time to recovery without significant side effects. Registration No: IRCT201103255764N2 PMID:22522994

A pragmatic cluster randomised trial evaluating three implementation interventions

Directory of Open Access Journals (Sweden)

Rycroft-Malone Jo

2012-08-01

Full Text Available Abstract Background Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. Methods A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA. The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. Results Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. Conclusions This was a large, complex study and one of the first

Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE: a randomized controlled trial protocol

Directory of Open Access Journals (Sweden)

Winstein Carolee J

2013-01-01

Full Text Available Abstract Background Residual disability after stroke is substantial; 65% of patients at 6 months are unable to incorporate the impaired upper extremity into daily activities. Task-oriented training programs are rapidly being adopted into clinical practice. In the absence of any consensus on the essential elements or dose of task-specific training, an urgent need exists for a well-designed trial to determine the effectiveness of a specific multidimensional task-based program governed by a comprehensive set of evidence-based principles. The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE Stroke Initiative is a parallel group, three-arm, single blind, superiority randomized controlled trial of a theoretically-defensible, upper extremity rehabilitation program provided in the outpatient setting. The primary objective of ICARE is to determine if there is a greater improvement in arm and hand recovery one year after randomization in participants receiving a structured training program termed Accelerated Skill Acquisition Program (ASAP, compared to participants receiving usual and customary therapy of an equivalent dose (DEUCC. Two secondary objectives are to compare ASAP to a true (active monitoring only usual and customary (UCC therapy group and to compare DEUCC and UCC. Methods/design Following baseline assessment, participants are randomized by site, stratified for stroke duration and motor severity. 360 adults will be randomized, 14 to 106 days following ischemic or hemorrhagic stroke onset, with mild to moderate upper extremity impairment, recruited at sites in Atlanta, Los Angeles and Washington, D.C. The Wolf Motor Function Test (WMFT time score is the primary outcome at 1 year post-randomization. The Stroke Impact Scale (SIS hand domain is a secondary outcome measure. The design includes concealed allocation during recruitment, screening and baseline, blinded outcome assessment and intention to treat analyses. Our primary

Intravenous lidocaine for post-operative pain relief after hand-assisted laparoscopic colon surgery: a randomized, placebo-controlled clinical trial.

Science.gov (United States)

Tikuišis, R; Miliauskas, P; Samalavičius, N E; Žurauskas, A; Samalavičius, R; Zabulis, V

2014-04-01

Perioperative intravenous (IV) infusion of lidocaine has been shown to decrease post-operative pain, shorten time to return of bowel function, and reduce the length of hospital stay. This randomized, prospective, double-blinded, placebo-controlled clinical trial evaluated the impact of IV lidocaine on the quality of post-operative analgesia and other outcomes after hand-assisted laparoscopic colon surgery. Sixty four patients with colon cancer scheduled for elective colon resection were involved in this study. Patients were randomized to receive either lidocaine infusion [lidocaine group (LG)] or normal 0.9 % saline infusion [placebo group (PG)] for a period of 24 h. Anaesthetic and surgical techniques were standardized. Twenty-four-hour post-operative analgesia in the recovery area was maintained by continuous infusion of 0.1 μg/kg/h fentanyl. The primary outcome of the study was post-operative pain control. Pain was assessed using visual analogue scale (VAS) scores at 2, 4, 8, 12, and 24 h after surgery. Patients with a VAS score >3 were treated with ketorolac 30 mg as needed. Secondary outcomes included time to resumption of bowel function and length of hospital stay. Data in the two groups were compared using the two-tailed Student's t test. All statistical tests were two-tailed at a significance level of 0.05. Demographic characteristics and clinical features of both groups were similar. Intensity of pain at rest in LG compared with PG was significantly lower during the first 24 h post-operatively. LG patients reported significantly less pain during movements at 2-, 12-, and 24-h post-surgery than PG patients. The study showed that ketorolac consumption was significantly higher in PG: mean ketorolac consumption in LG was 43.77 ± 13.86 mg and in PG 51.67 ± 13.16 mg (p = 0.047). Compared with placebo, lidocaine infusion produced a 32 % reduction in time to the first drink (Cohen's d = 3.85), 16 % reduction in time to the first full diet

Multicenter evaluation of rectal cancer reimaging post neoadjuvant (MERRION) therapy.

LENUS (Irish Health Repository)

Hanly, Ann M

2014-04-01

The aim of this study was to evaluate the utility of reimaging rectal cancer post-CRT (chemoradiotherapy) with magnetic resonance (MR) imaging of the pelvis for local staging and computed tomography of thorax, abdomen, and pelvis (CT TAP) to identify distant metastases.

Tranexamic acid for treatment of women with post-partum haemorrhage in Nigeria and Pakistan: a cost-effectiveness analysis of data from the WOMAN trial.

Science.gov (United States)

Li, Bernadette; Miners, Alec; Shakur, Haleema; Roberts, Ian

2018-02-01

Sub-Saharan Africa and southern Asia account for almost 85% of global maternal deaths from post-partum haemorrhage. Early administration of tranexamic acid, within 3 h of giving birth, was shown to reduce the risk of death due to bleeding in women with post-partum haemorrhage in the World Maternal Antifibrinolytic (WOMAN) trial. We aimed to assess the cost-effectiveness of early administration of tranexamic acid for treatment of post-partum haemorrhage. For this economic evaluation we developed a decision model to assess the cost-effectiveness of the addition of tranexamic acid to usual care for treatment of women with post-partum haemorrhage in Nigeria and Pakistan. We used data from the WOMAN trial to inform model parameters, supplemented by estimates from the literature. We estimated costs (calculated in 2016 US$), life-years, and quality-adjusted life-years (QALYs) with and without tranexamic acid, calculated incremental cost-effectiveness ratios (ICERs), and compared these to threshold values in each country. Costs were assessed from the health-care provider perspective and discounted at 3% per year in the base case analysis. We did a series of one-way sensitivity analyses and probabilistic sensitivity analysis to assess the robustness of the results to parameter uncertainty. Early treatment of post-partum haemorrhage with tranexamic acid generated an average gain of 0·18 QALYs at an additional cost of $37·12 per patient in Nigeria and an average gain of 0·08 QALYs at an additional cost of $6·55 per patient in Pakistan. The base case ICER results were $208 per QALY in Nigeria and $83 per QALY in Pakistan. These ICERs were below the lower bound of the cost-effectiveness threshold range in both countries. The ICERs were most sensitive to uncertainty in parameter inputs for the relative risk of death due to bleeding with tranexamic acid, the discount rate, the cost of the drug, and the baseline probability of death due to bleeding. Early treatment of post

A randomised controlled trial of prophylaxis of post-abortal infection: ceftriaxone versus placebo

DEFF Research Database (Denmark)

Henriques, C U; Wilken-Jensen, C; Thorsen, P

1994-01-01

days postoperatively, underwent pelvic examination. Clinical endpoints were noted. MAIN OUTCOME MEASURES: Post-operative pelvic inflammatory disease in women applying for legal first trimester abortion. RESULTS: Seven hundred and eighty-six women fulfilled the criteria for evaluation. A tendency toward...... for legal first trimester abortion, treated peroperatively with ceftriaxone. No significant difference was demonstrated between high risk patients treated with ceftriaxone or ampicillin/pivampicillin and metronidazole. Udgivelsesdato: 1994-Jul......OBJECTIVE: To investigate the incidence of post-operative infection after first trimester abortion in women treated with a long-acting cephalosporin (ceftriaxone) compared with low risk patients receiving no treatment and with high risk patients receiving our standard treatment of ampicillin...

Effectiveness of two home ergonomic programs in reducing pain and enhancing quality of life in informal caregivers of post-stroke patients: A pilot randomized controlled clinical trial.

Science.gov (United States)

de Araújo Freitas Moreira, Karen Lucia; Ábalos-Medina, Gracia María; Villaverde-Gutiérrez, Carmen; Gomes de Lucena, Neide María; Belmont Correia de Oliveira, Anderson; Pérez-Mármol, José Manuel

2018-02-13

Informal caregivers of post-stroke patients usually undergo high levels of pain and stress and have a reduced quality of life. To evaluate the effectiveness of two home ergonomic interventions aimed at reducing pain intensity and perceived stress and enhancing the quality of life in informal caregivers of chronic post-stroke patients. A randomized single-blind controlled clinical trial was conducted, with a sample of 33 informal caregivers of patients with stroke. Three groups were included: one received postural hygiene training and kinesiotherapy, for 12 weeks, two days a week, one hour per session; another received adaptation of the home environment, and the third was a control group. Pain intensity, stress level and general quality of life were evaluated at three-time points: pre-intervention, post-intervention, and after a follow-up period of three months. Neck pain decreased in the two experimental groups, and increased in the control group. Pain in the shoulders and knees was alleviated in the group that received postural hygiene and kinesiotherapy. In addition, regarding quality of life, this group obtained an improvement in the physical health dimension, while the home adaptation group reported improved social relationships. These results suggest that 12 weeks of training in postural hygiene, combined with kinesiotherapy, and home adaptations can reduce pain and improve several aspects of the quality of life of this population. CLINICALTRIALS. NCT03284580. Copyright © 2018 Elsevier Inc. All rights reserved.

Comparison of Single Visit Post Endodontic Pain Using Mtwo Rotary and Hand K-File Instruments: A Randomized Clinical Trial.

Science.gov (United States)

Kashefinejad, Mohamad; Harandi, Azade; Eram, Saeed; Bijani, Ali

2016-01-01

Pain is an unpleasant outcome of endodontic treatment that can be unbearable to patients. Instrumentation techniques may affect the frequency and intensity of post-endodontic pain. This study aimed to compare single visit post endodontic pain using Mtwo (NiTi) rotary and hand K-file instruments. In this randomized controlled trial, 60 teeth with symptomatic irreversible pulpitis in 53 patients were selected and randomly assigned into two groups of 30 teeth. In group A, the root canals were prepared with Mtwo (NiTi) rotary instruments. In group B, the root canals were prepared with hand K-file instruments. Pain assessment was implemented using visual analog scale (VAS) at four, eight, 12 and 24 hours after treatment. The acquired data were analyzed using chi-square, Mann-Whitney U and Student's t-test (Protary instruments experienced significantly less post-endodontic pain than those treated with hand instruments (Protary instruments in root canal preparation contributed to lower incidence of postoperative pain than hand K-files.

Evaluation of a cognitive psychophysiological model for management of tic disorders: an open trial.

Science.gov (United States)

O'Connor, Kieron; Lavoie, Marc; Blanchet, Pierre; St-Pierre-Delorme, Marie-Ève

2016-07-01

Tic disorders, in particular chronic tic disorder and Tourette syndrome, affect about 1% of the population. The current treatment of choice is pharmacological or behavioural, addressing tics or the premonitory urges preceding tic onset. The current study reports an open trial evaluating the effectiveness of a cognitive psychophysiological treatment addressing Tourette-specific sensorimotor activation processes rather than the tic. Forty-nine people with Tourette syndrome and 36 people with chronic tics completed 10 weeks of individual cognitive psychophysiological therapy. Outcome measures included two tic severity scales and psychosocial measures. Post-treatment both groups had significantly improved on the tic scales with strong effect sizes across tic locations and complex and simple tics, maintained at 6-month follow-up with further change in perfectionism and self-esteem. The cognitive psychophysiological approach targeting underlying sensorimotor processes rather than tics in Tourette's and chronic tic disorder reduced symptoms with a large effect size. © The Royal College of Psychiatrists 2016.

OARSI Clinical Trials Recommendations

DEFF Research Database (Denmark)

Emery, C. A.; Roos, Ewa M.; Verhagen, E.

2015-01-01

The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform...... the design, conduct and analytical approaches to RCTs evaluating the preventative effect of joint injury prevention strategies. Recommendations regarding the design, conduct, and reporting of RCTs evaluating injury prevention interventions were established based on the consensus of nine researchers...... internationally with expertise in epidemiology, injury prevention and/or osteoarthritis (OA). Input and resultant consensus was established through teleconference, face to face and email correspondence over a 1 year period. Recommendations for injury prevention RCTs include context specific considerations...

Evaluation of cluster-randomized trials on maternal and child health research in developing countries

DEFF Research Database (Denmark)

Handlos, Line Neerup; Chakraborty, Hrishikesh; Sen, Pranab Kumar

2009-01-01

To summarize and evaluate all publications including cluster-randomized trials used for maternal and child health research in developing countries during the last 10 years. METHODS: All cluster-randomized trials published between 1998 and 2008 were reviewed, and those that met our criteria...... for inclusion were evaluated further. The criteria for inclusion were that the trial should have been conducted in maternal and child health care in a developing country and that the conclusions should have been made on an individual level. Methods of accounting for clustering in design and analysis were......, and the trials generally improved in quality. CONCLUSIONS: Shortcomings exist in the sample-size calculations and in the analysis of cluster-randomized trials conducted during maternal and child health research in developing countries. Even though there has been improvement over time, further progress in the way...

The efficacy of different pre- and post-operative analgesics in the management of pain after orthodontic separator placement: A randomized clinical trial

Directory of Open Access Journals (Sweden)

V Sudhakar

2014-01-01

Full Text Available Introduction: Pain-free treatment to the patients is considered as an important treatment objective for orthodontic health care providers. However, many orthodontists underestimate the degree of pain experienced by the patients. Hence, this study was conducted as a randomized, double-blinded clinical trial with the following objectives. Objective: To study the pain characteristics after separator placement; to compare the efficacy of various commonly used analgesics in pain management and to determine the efficacy of pre- and post-operative analgesics in pain management. Subjects and Methods: Data were collected from 154 patients (77 males and 77 females, age group of 14-21 years, with mean age of 18.8 years who reported to Department of Orthodontics. Patients were randomly divided in to four groups. Group 1: Paracetamol 650 mg, Group 2: Ibuprofen 400 mg, Group 3: Aspirin 300 mg, Group 4: Placebo and the study were conducted as a randomized, double-blinded clinical trial. The patients were instructed to take two tablets, one tablet 1 h before separator placement, and the other one after 6 h. The pain evaluations were made by the patients, when teeth not touching (TNT, biting back teeth together, chewing food (CF using a 100-mm visual analogue scale for 7 days after separator placement. Patients were advised to record the severity of pain. Results: Group 3 (Aspirin 300 mg showed lowest pain values, followed by Group 2 (ibuprofen 400 mg, and Group 1 (paracetamol 650 mg. All NSAID′s achieved good pain control compared to Group 4 (placebo, where the intensity pain was maximum. Conclusion: Pre- and post-operative analgesics were found to be more effective in controlling orthodontic pain, after separator placement at all-time intervals.

Trial-based economic evaluations in occupational health: principles, methods, and recommendations.

Science.gov (United States)

van Dongen, Johanna M; van Wier, Marieke F; Tompa, Emile; Bongers, Paulien M; van der Beek, Allard J; van Tulder, Maurits W; Bosmans, Judith E

2014-06-01

To allocate available resources as efficiently as possible, decision makers need information on the relative economic merits of occupational health and safety (OHS) interventions. Economic evaluations can provide this information by comparing the costs and consequences of alternatives. Nevertheless, only a few of the studies that consider the effectiveness of OHS interventions take the extra step of considering their resource implications. Moreover, the methodological quality of those that do is generally poor. Therefore, this study aims to help occupational health researchers conduct high-quality trial-based economic evaluations by discussing the theory and methodology that underlie them, and by providing recommendations for good practice regarding their design, analysis, and reporting. This study also helps consumers of this literature with understanding and critically appraising trial-based economic evaluations of OHS interventions.

Evaluator-blinded trial evaluating nurse-led immunotherapy DEcision Coaching In persons with relapsing-remitting Multiple Sclerosis (DECIMS) and accompanying process evaluation: study protocol for a cluster randomised controlled trial.

Science.gov (United States)

Rahn, Anne Christin; Köpke, Sascha; Kasper, Jürgen; Vettorazzi, Eik; Mühlhauser, Ingrid; Heesen, Christoph

2015-03-21

Multiple sclerosis is a chronic neurological condition usually starting in early adulthood and regularly leading to severe disability. Immunotherapy options are growing in number and complexity, while costs of treatments are high and adherence rates remain low. Therefore, treatment decision-making has become more complex for patients. Structured decision coaching, based on the principles of evidence-based patient information and shared decision-making, has the potential to facilitate participation of individuals in the decision-making process. This cluster randomised controlled trial follows the assumption that decision coaching by trained nurses, using evidence-based patient information and preference elicitation, will facilitate informed choices and induce higher decision quality, as well as better decisional adherence. The decision coaching programme will be evaluated through an evaluator-blinded superiority cluster randomised controlled trial, including 300 patients with suspected or definite relapsing-remitting multiple sclerosis, facing an immunotherapy decision. The clusters are 12 multiple sclerosis outpatient clinics in Germany. Further, the trial will be accompanied by a mixed-methods process evaluation and a cost-effectiveness study. Nurses in the intervention group will be trained in shared decision-making, coaching, and evidence-based patient information principles. Patients who meet the inclusion criteria will receive decision coaching (intervention group) with up to three face-to-face coaching sessions with a trained nurse (decision coach) or counselling as usual (control group). Patients in both groups will be given access to an evidence-based online information tool. The primary outcome is 'informed choice' after six months, assessed with the multi-dimensional measure of informed choice including the sub-dimensions risk knowledge (questionnaire), attitude concerning immunotherapy (questionnaire), and immunotherapy uptake (telephone survey

Design, history and results of the Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) randomised controlled trial

DEFF Research Database (Denmark)

Punthakee, Z; Bosch, J; Dagenais, G

2012-01-01

AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs (rosiglit......AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs...

Ankle manual therapy for individuals with post-acute ankle sprains: description of a randomized, placebo-controlled clinical trial

Directory of Open Access Journals (Sweden)

Fisher Beth E

2010-10-01

Full Text Available Abstract Background Ankle sprains are common within the general population and can result in prolonged disablement. Limited talocrural dorsiflexion range of motion (DF ROM is a common consequence of ankle sprain. Limited talocrural DF ROM may contribute to persistent symptoms, disability, and an elevated risk for re-injury. As a result, many health care practitioners use hands-on passive procedures with the intention of improving talocrural joint DF ROM in individuals following ankle sprains. Dosage of passive hands-on procedures involves a continuum of treatment speeds. Recent evidence suggests both slow- and fast-speed treatments may be effective to address disablement following ankle sprains. However, these interventions have yet to be longitudinally compared against a placebo study condition. Methods/Design We developed a randomized, placebo-controlled clinical trial designed to test the hypotheses that hands-on treatment procedures administered to individuals following ankle sprains during the post-acute injury period can improve short-, intermediate-, and long-term disablement, as well as reduce the risk for re-injury. Discussion This study is designed to measure the clinical effects of hands-on passive stretching treatment procedures directed to the talocrural joint that vary in treatment speed during the post-acute injury period, compared to hands-on placebo control intervention. Trial Registration http://www.clinicaltrials.gov identifier NCT00888498.

Preliminary evaluation of factors associated with premature trial closure and feasibility of accrual benchmarks in phase III oncology trials.

Science.gov (United States)

Schroen, Anneke T; Petroni, Gina R; Wang, Hongkun; Gray, Robert; Wang, Xiaofei F; Cronin, Walter; Sargent, Daniel J; Benedetti, Jacqueline; Wickerham, Donald L; Djulbegovic, Benjamin; Slingluff, Craig L

2010-08-01

A major challenge for randomized phase III oncology trials is the frequent low rates of patient enrollment, resulting in high rates of premature closure due to insufficient accrual. We conducted a pilot study to determine the extent of trial closure due to poor accrual, feasibility of identifying trial factors associated with sufficient accrual, impact of redesign strategies on trial accrual, and accrual benchmarks designating high failure risk in the clinical trials cooperative group (CTCG) setting. A subset of phase III trials opened by five CTCGs between August 1991 and March 2004 was evaluated. Design elements, experimental agents, redesign strategies, and pretrial accrual assessment supporting accrual predictions were abstracted from CTCG documents. Percent actual/predicted accrual rate averaged per month was calculated. Trials were categorized as having sufficient or insufficient accrual based on reason for trial termination. Analyses included univariate and bivariate summaries to identify potential trial factors associated with accrual sufficiency. Among 40 trials from one CTCG, 21 (52.5%) trials closed due to insufficient accrual. In 82 trials from five CTCGs, therapeutic trials accrued sufficiently more often than nontherapeutic trials (59% vs 27%, p = 0.05). Trials including pretrial accrual assessment more often achieved sufficient accrual than those without (67% vs 47%, p = 0.08). Fewer exclusion criteria, shorter consent forms, other CTCG participation, and trial design simplicity were not associated with achieving sufficient accrual. Trials accruing at a rate much lower than predicted (accrual rate) were consistently closed due to insufficient accrual. This trial subset under-represents certain experimental modalities. Data sources do not allow accounting for all factors potentially related to accrual success. Trial closure due to insufficient accrual is common. Certain trial design factors appear associated with attaining sufficient accrual. Defining

Thallium imaging in management of post-revascularization patients

International Nuclear Information System (INIS)

Alazraki, N.; Krawczynska, E.

1996-01-01

The role of myocardial perfusion imaging in the evaluation of post revascularization patients has not been well defined. Published data with special emphasis on the results from the Emory Angioplasty versus Surgery Trial (EAST) indicate that the frequency of adverse cardiac events (death, MI, repeat revascularization) following PTCA or CABG is equal in symptomatic and asymptomatic patients with ischemic thallium defects. Current American Heart Association Guidelines recommend radionuclide studies only in symptomatic patients. Recently reported data support the need for non invasive testing in asymptomatic as well as symptomatic patients at 1 year postrevascularization. Prognostic variables including transient and permanent left ventricular dilatation and thallium lung uptake in addition to stress perfusion defect reversibility on myocardial thallium SPECT scans are important prognostic indicators in post revascularization patients

Bortezomib-based vs non-bortezomib-based post-transplantation treatment in multiple myeloma patients: a systematic review and meta-analysis of Phase III randomized controlled trials

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Liu XP

2015-06-01

Full Text Available Xiaoping Liu,1 Colin K He,2 Xiangyu Meng,1 Li He,1 Kaili Li,1 Qing Liang,1 Liang Shao,1 Shangqin Liu1 1Department of Hematology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, People’s Republic of China; 2Orient Health Care, NYC, USA Objective: To evaluate the efficacy and safety of bortezomib-based vs non-bortezomib-based post-transplantation therapy in patients with multiple myeloma.Methods: Data of relevant randomized controlled trials assessing the effect of bortezomib as post-transplantation consolidation or maintenance therapy was obtained through a comprehensive search. The outcome measures included response rate, progression-free survival, overall survival, and adverse events (AEs. The hazard ratio (HR, Cochran-Mantel-Haenszel odds ratio (OR, and 95% confidence interval (95% CI were applied to evaluate the effect of bortezomib in relation to the end points such as progression-free survival, overall survival, response rate, and AEs.Results: Three randomized controlled trials comprising 1,518 participants were included in this study. Pooled ORs for the rates of overall response, and complete response and near complete response, were 1.85 and 1.75, respectively. Pooled HR for progression-free survival favored bortezomib-based therapy over non-bortezomib-based therapy (0.73, 95% CI: 0.67–0.81, while no statistically significant difference could be found between the two groups regarding the pooled HR for 3-year overall survival. Moreover, incidence rates of overall adverse events and grade 3 and 4 peripheral neuropathy were similar in the bortezomib-based groups and the non-bortezomib-based groups (P=0.12 and P=0.41, respectively. The corresponding cumulative meta-analyses of the rates of overall response rate, complete response and near complete response, and grades 3 and 4 peripheral neuropathy supported the superiority of bortezomib-based maintenance therapy over consolidation therapy.Conclusion: Bortezomib-based therapy after

"Ferrule Comes First. Post Is Second!" Fake News and Alternative Facts? A Systematic Review.

Science.gov (United States)

Naumann, Michael; Schmitter, Marc; Frankenberger, Roland; Krastl, Gabriel

2018-02-01

Both the role of an endodontic post and the ferrule effect have been discussed for decades. The clinical impact of endodontic posts compared with post-free restoration with or without ferrule support was not systematically reviewed so far. It was assumed that the effect of an endodontic post compared with a post-free restoration can be evaluated only when at the same time a ferrule or no-ferrule situation was clinically compared. The specific PICO question was as follows: Patient: adults with sufficient endodontic treatment needing a core or post; Intervention: post-endodontic treatment using posts with or without ferrule; Comparison: post-endodontic treatment without posts with or without ferrule; Outcomes: failure rates of post/core complexes with or without ferrule support. A Medline search was performed via PubMed in June 2017 using relevant electronic databases. Additionally, hand search was performed. Only prospective clinical studies in humans comparing the success/survival of teeth restored with or without posts over a minimum time of observation of 5 years were included. In total, 7 randomized controlled trials and 1 prospective clinical trial met inclusion criteria. Cochrane rating showed high risk of bias in 5 studies. Two of 3 studies support the ferrule-effect concept. Seven of 8 show no post effect. Clinical evidence regarding the influence of tooth location on its survival is scarce. Ferrule effect and maintaining cavity walls are the predominant factors with regard to tooth and restoration survival of endodontically treated teeth. Most studies do not confirm a positive effect of post placement. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Effect of ultraviolet light irradiation on bond strength of fiber post: Evaluation of surface characteristic and bonded area of fiber post with resin cement

OpenAIRE

Reza, Fazal; Ibrahim, Nur Sukainah

2015-01-01

Objective: Fiber post is cemented to a root canal to restore coronal tooth structure. This research aims to evaluate the effect of ultraviolet (UV) irradiation on bond strength of fiber post with resin cement. Materials and Methods: A total of 40 of the two types of fiber posts, namely, FRC Prostec (FRC) and Fiber KOR (KOR), were used for the experiment. UV irradiation was applied on top of the fiber post surface for 0, 15, 20, and 30 min. The irradiated surface of the fiber posts (n = 5) wer...

Imaging Neuroinflammation in Post Traumatic Stress Disorder

Science.gov (United States)

2012-11-01

Post traumatic stress disorder ( PTSD ) is a complex...several central nervous system conditions including post - traumatic stress disorder ( PTSD ) and traumatic brain injury (TBI). Microglia represent over...trials. We have subsequently identified a better agent for interrogating TSPO in post - traumatic stress disorder ( PTSD ) subjects, 18-F PBR111, a

Immediate effects of acupuncture on biceps brachii muscle function in healthy and post-stroke subjects

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Fragoso Ana

2012-03-01

Full Text Available Abstract Background The effects of acupuncture on muscle function in healthy subjects are contradictory and cannot be extrapolated to post-stroke patients. This study evaluated the immediate effects of manual acupuncture on myoelectric activity and isometric force in healthy and post-stroke patients. Methods A randomized clinical trial, with parallel groups, single-blinded study design, was conducted with 32 healthy subjects and 15 post-stroke patients with chronic hemiparesis. Surface electromyography from biceps brachii during maximal isometric voluntary tests was performed before and after 20-min intermittent, and manual stimulation of acupoints Quchi (LI11 or Tianquan (PC2. Pattern differentiation was performed by an automated method based on logistic regression equations. Results Healthy subjects showed a decrease in the root mean-squared (RMS values after the stimulation of LI11 (pre: 1.392 ± 0.826 V; post: 0.612 ± 0.0.320 V; P = 0.002 and PC2 (pre: 1.494 ± 0.826 V; post: 0.623 ± 0.320 V; P = 0.001. Elbow flexion maximal isometric voluntary contraction (MIVC was not significantly different after acupuncture stimulation of LI11 (pre: 22.2 ± 10.7 kg; post: 21.7 ± 9.5 kg; P = 0.288 or PC2 (pre: 18.8 ± 4.6 kg; post: 18.7 ± 6.0 kg; P = 0.468. Post-stroke patients did not exhibit any significant decrease in the RMS values after the stimulation of LI11 (pre: 0.627 ± 0.335 V; post: 0.530 ± 0.272 V; P = 0.187 and PC2 (pre: 0.601 ± 0.258 V; post: 0.591 ± 0.326 V; P = 0.398. Also, no significant decrease in the MIVC value was observed after the stimulation of LI11 (pre: 9.6 ± 3.9 kg; post: 9.6 ± 4.7 kg; P = 0.499 or PC2 (pre: 10.7 ± 5.6 kg; post: 10.2 ± 5.3 kg; P = 0.251. Different frequency of patterns was observed among healthy subjects and post-stroke patients groups (χ2 = 9.759; P = 0.021. Conclusion Manual acupuncture provides sufficient neuromuscular stimuli to promote immediate changes in motor unit gross recruitment without

Reducing child abuse amongst adolescents in low- and middle-income countries: A pre-post trial in South Africa

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Lucie Cluver

2016-07-01

Full Text Available Abstract Background No known studies have tested the effectiveness of child abuse prevention programmes for adolescents in low- or middle-income countries. ‘Parenting for Lifelong Health’ ( http://tiny.cc/whoPLH is a collaborative project to develop and rigorously test abuse-prevention parenting programmes for free use in low-resource contexts. Research aims of this first pre-post trial in South Africa were: i to identify indicative effects of the programme on child abuse and related outcomes; ii to investigate programme safety for testing in a future randomised trial, and iii to identify potential adaptations. Methods Two hundred thirty participants (adolescents and their primary caregivers were recruited from schools, welfare services and community-sampling in rural, high-poverty South Africa (no exclusion criteria. All participated in a 12-week parenting programme, implemented by local NGO childcare workers to ensure real-world external validity. Standardised pre-post measures with adolescents and caregivers were used, and paired t-tests were conducted for primary outcomes: abuse (physical, emotional abuse and neglect, adolescent behaviour problems and parenting (positive and involved parenting, poor monitoring and inconsistent discipline, and secondary outcomes: mental health, social support and substance use. Results Participants reported high levels of socio-economic deprivation, e.g. 60 % of adolescents had either an HIV-positive caregiver or were orphaned by AIDS, and 50 % of caregivers experienced intimate partner violence. i indicative effects: Primary outcomes comparing pre-test and post-test assessments showed reductions reported by adolescents and caregivers in child abuse (adolescent report 63.0 % pre-test to 29.5 % post-test, caregiver report 75.5 % pre-test to 36.5 % post-test, both p < 0.001 poor monitoring/inconsistent discipline (p < .001, adolescent delinquency/aggressive behaviour (both p < .001, and

Impact of copula directional specification on multi-trial evaluation of surrogate endpoints

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Renfro, Lindsay A.; Shang, Hongwei; Sargent, Daniel J.

2014-01-01

Evaluation of surrogate endpoints using patient-level data from multiple trials is the gold standard, where multi-trial copula models are used to quantify both patient-level and trial-level surrogacy. While limited consideration has been given in the literature to copula choice (e.g., Clayton), no prior consideration has been given to direction of implementation (via survival versus distribution functions). We demonstrate that evenwith the “correct” copula family, directional misspecification leads to biased estimates of patient-level and trial-level surrogacy. We illustrate with a simulation study and a re-analysis of disease-free survival as a surrogate for overall survival in early stage colon cancer. PMID:24905465

Using automated voice messages linked to telephone counselling to increase post-menstrual regulation contraceptive uptake and continuation in Bangladesh: study protocol for a randomised controlled trial

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Kate Reiss

2017-10-01

Full Text Available Abstract Background Adoption of modern contraceptive methods after menstrual regulation (MR is thought to reduce subsequent unwanted pregnancy and abortion. Long-acting reversible contraceptives (LARCs are highly effective at reducing unintended pregnancy, but uptake in Bangladesh is low. Providing information on the most effective methods of contraception increases uptake of more effective methods. This protocol describes a randomised controlled trial of an intervention delivered by mobile phone designed to support post-MR contraceptive use in Bangladesh. Methods This is a multi-site single blind individual randomised controlled trial. At least 960 women undergoing MR procedures at selected facilities will be recruited after their procedure by female research assistants. Women will be randomised into the control or intervention group with a 1:1 ratio. All participants will receive usual clinic care, including contraceptive counselling and the telephone number of a non-toll-free call centre which provides counselling on MR and contraception. During the 4 months after their MR procedure, intervention participants will be sent 11 recorded interactive voice messages to their mobile phone about contraception with a focus on their chosen method and LARCs. Each message allows the participant to connect directly to the call centre. The intervention is free to the user. The control group will receive no messages delivered by mobile phone. All participants will be asked to complete an in-person questionnaire at recruitment and follow-up questionnaires by telephone at 2 weeks, 4 months and 12 months after their MR. The primary outcome for the trial will be self-reported LARC use 4 months post-MR. Secondary outcomes include LARC use at 2 weeks and 12 months post-MR, use of any effective modern contraceptive method at 2 weeks, 4 months and 12 months post-MR, and contraceptive discontinuation, contraceptive method switching, pregnancy, subsequent MR and

Evaluating Post-Radiotherapy Laryngeal Function with Laryngeal Videostroboscopy in Early Stage Glottic Cancer

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Ariel E. Marciscano

2017-06-01

Full Text Available ObjectiveDysphonia is common among patients with early stage glottic cancer. Laryngeal videostroboscopy (LVS has not been routinely used to assess post-radiotherapy (RT voice changes. We hypothesized that LVS would demonstrate improvement in laryngeal function after definitive RT for early-stage glottic cancer.Study designBlinded retrospective review of perceptual voice and stroboscopic parameters for patients with early glottic cancer and controls.SettingHigh-volume, single-institution academic medical center.Subjects and methodsFifteen patients underwent RT for Tis-T2N0M0 glottic cancer and were evaluated with serial LVS exams pre- and post-RT. Stroboscopic assessment included six parameters: vocal fold (VF vibration, VF mobility, erythema/edema, supraglottic compression, glottic closure, and secretions. Grade, roughness, breathiness, asthenia, strain (GRBAS voice perceptual scale was graded in tandem with LVS score. Assessments were grouped by time interval from RT: pre-RT, 0–4, 4–12, and >12 months post-RT.Results60 LVS exams and corresponding GRBAS assessments were reviewed. There were significant improvements in ipsilateral VF motion (P = 0.03 and vibration (P = 0.001 and significant worsening in contralateral VF motion (P < 0.001 and vibration (P = 0.008 at >12 months post-RT. Glottic closure significantly worsened, most prominent >12 months post-RT (P = 0.01. Composite GRBAS scores were significantly improved across all post-RT intervals.ConclusionLVS proved to be a robust tool for assessing pre- and post-RT laryngeal function. We observed post-RT improvement in ipsilateral VF function, a decline in contralateral VF function, and decreased glottic closure. These results demonstrate that LVS can detect meaningful changes in VF and glottic function and support its use for post-RT evaluation of glottic cancer patients.

[Methodological quality and reporting quality evaluation of randomized controlled trials published in China Journal of Chinese Materia Medica].

Science.gov (United States)

Yu, Dan-Dan; Xie, Yan-Ming; Liao, Xing; Zhi, Ying-Jie; Jiang, Jun-Jie; Chen, Wei

2018-02-01

To evaluate the methodological quality and reporting quality of randomized controlled trials(RCTs) published in China Journal of Chinese Materia Medica, we searched CNKI and China Journal of Chinese Materia webpage to collect RCTs since the establishment of the magazine. The Cochrane risk of bias assessment tool was used to evaluate the methodological quality of RCTs. The CONSORT 2010 list was adopted as reporting quality evaluating tool. Finally, 184 RCTs were included and evaluated methodologically, of which 97 RCTs were evaluated with reporting quality. For the methodological evaluating, 62 trials(33.70%) reported the random sequence generation; 9(4.89%) trials reported the allocation concealment; 25(13.59%) trials adopted the method of blinding; 30(16.30%) trials reported the number of patients withdrawing, dropping out and those lost to follow-up;2 trials （1.09%） reported trial registration and none of the trial reported the trial protocol; only 8(4.35%) trials reported the sample size estimation in details. For reporting quality appraising, 3 reporting items of 25 items were evaluated with high-quality,including: abstract, participants qualified criteria, and statistical methods; 4 reporting items with medium-quality, including purpose, intervention, random sequence method, and data collection of sites and locations; 9 items with low-quality reporting items including title, backgrounds, random sequence types, allocation concealment, blindness, recruitment of subjects, baseline data, harms, and funding;the rest of items were of extremely low quality(the compliance rate of reporting item<10%). On the whole, the methodological and reporting quality of RCTs published in the magazine are generally low. Further improvement in both methodological and reporting quality for RCTs of traditional Chinese medicine are warranted. It is recommended that the international standards and procedures for RCT design should be strictly followed to conduct high-quality trials

[Process and key points of clinical literature evaluation of post-marketing traditional Chinese medicine].

Science.gov (United States)

Liu, Huan; Xie, Yanming

2011-10-01

The clinical literature evaluation of the post-marketing traditional Chinese medicine is a comprehensive evaluation by the comprehensive gain, analysis of the drug, literature of drug efficacy, safety, economy, based on the literature evidence and is part of the evaluation of evidence-based medicine. The literature evaluation in the post-marketing Chinese medicine clinical evaluation is in the foundation and the key position. Through the literature evaluation, it can fully grasp the information, grasp listed drug variety of traditional Chinese medicines second development orientation, make clear further clinical indications, perfect the medicines, etc. This paper discusses the main steps and emphasis of the clinical literature evaluation. Emphasizing security literature evaluation should attach importance to the security of a comprehensive collection drug information. Safety assessment should notice traditional Chinese medicine validity evaluation in improving syndrome, improveing the living quality of patients with special advantage. The economics literature evaluation should pay attention to reliability, sensitivity and practicability of the conclusion.

Evaluating prestressing strands and post-tensioning cables in concrete structures using nondestructive methods.

Science.gov (United States)

2015-11-01

The objectives were to evaluate the ability of different NDE methods to detect and quantify : defects associated with corrosion of steel reinforcement and grout defects in post-tensioning : applications; and to evaluate the effectiveness of selected ...

Adding a post-training FIFA 11+ exercise program to the pre-training FIFA 11+ injury prevention program reduces injury rates among male amateur soccer players: a cluster-randomised trial

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Wesam Saleh A Al Attar

2017-10-01

Trial registration: ACTRN12615001206516. [Al Attar WSA, Soomro N, Pappas E, Sinclair PJ, Sanders RH (2017 Adding a post-training FIFA 11+ exercise program to the pre-training FIFA 11+ injury prevention program reduces injury rates among male amateur soccer players: a cluster-randomised trial. Journal of Physiotherapy 63: 235–242

Evaluation of post-operative prophylactic irradiation for carcinoma of the esophagus

International Nuclear Information System (INIS)

Mafune, Ken-ichi; Tanaka, Yoichi; Fujita, Kichishiro; Sakura, Mizuyoshi

1987-01-01

Of 147 patients with carcinoma of the esophagus resected at Saitama Cancer Center Hospital for 10 years, 98 cases were studied to evaluate post-operative prophylactic irradiation. The total dose of irradiation was up to 4,000 ∼ 5,000 rads of Linac X-ray and the irradiated field was T-shaped covering the upper mediastinal and bilateral cervical regions. The prognosis of the post-operative irradiated group (56 cases) was significantly better than that of the control group (42 cases) (p < 0.01). This study resulted in a five-year survival rate of 34.2 percent for patients in the post-operative irradiated group, compared to 16.7 percent for those in the control group. Further detailed comparative studies revealed similar results. Cancer recurrence occurred at the irradiated fields in 8 cases (14.3 %), though in 15 cases (35.7 %) of the control group. This suggested the local suppressive effect of the post-operative irradiation to the cancer recurrence. (author)

Experiences and perspectives of patients with post-polio syndrome and therapists with exercise and cognitive behavioural therapy

NARCIS (Netherlands)

Bakker, Minne; Schipper, Karen; Koopman, Fieke S.; Nollet, Frans; Abma, Tineke A.

2016-01-01

Many persons affected with poliomyelitis develop post-polio syndrome (PPS) later in their life. Recently, the effectiveness of Exercise Therapy (ET) and Cognitive Behavioural Therapy (CBT) for PPS has been evaluated in a randomized controlled trial, but did not show a decrease in fatigue or

A semi-automated tool for treatment plan-quality evaluation and clinical trial quality assurance

Science.gov (United States)

Wang, Jiazhou; Chen, Wenzhou; Studenski, Matthew; Cui, Yunfeng; Lee, Andrew J.; Xiao, Ying

2013-07-01

The goal of this work is to develop a plan-quality evaluation program for clinical routine and multi-institutional clinical trials so that the overall evaluation efficiency is improved. In multi-institutional clinical trials evaluating the plan quality is a time-consuming and labor-intensive process. In this note, we present a semi-automated plan-quality evaluation program which combines MIMVista, Java/MATLAB, and extensible markup language (XML). More specifically, MIMVista is used for data visualization; Java and its powerful function library are implemented for calculating dosimetry parameters; and to improve the clarity of the index definitions, XML is applied. The accuracy and the efficiency of the program were evaluated by comparing the results of the program with the manually recorded results in two RTOG trials. A slight difference of about 0.2% in volume or 0.6 Gy in dose between the semi-automated program and manual recording was observed. According to the criteria of indices, there are minimal differences between the two methods. The evaluation time is reduced from 10-20 min to 2 min by applying the semi-automated plan-quality evaluation program.

A semi-automated tool for treatment plan-quality evaluation and clinical trial quality assurance

International Nuclear Information System (INIS)

Wang, Jiazhou; Chen, Wenzhou; Studenski, Matthew; Cui, Yunfeng; Xiao, Ying; Lee, Andrew J

2013-01-01

The goal of this work is to develop a plan-quality evaluation program for clinical routine and multi-institutional clinical trials so that the overall evaluation efficiency is improved. In multi-institutional clinical trials evaluating the plan quality is a time-consuming and labor-intensive process. In this note, we present a semi-automated plan-quality evaluation program which combines MIMVista, Java/MATLAB, and extensible markup language (XML). More specifically, MIMVista is used for data visualization; Java and its powerful function library are implemented for calculating dosimetry parameters; and to improve the clarity of the index definitions, XML is applied. The accuracy and the efficiency of the program were evaluated by comparing the results of the program with the manually recorded results in two RTOG trials. A slight difference of about 0.2% in volume or 0.6 Gy in dose between the semi-automated program and manual recording was observed. According to the criteria of indices, there are minimal differences between the two methods. The evaluation time is reduced from 10–20 min to 2 min by applying the semi-automated plan-quality evaluation program. (note)

Antioxidant drugs to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis: What does evidence suggest?

Science.gov (United States)

Fuentes-Orozco, Clotilde; Dávalos-Cobián, Carlos; García-Correa, Jesús; Ambriz-González, Gabriela; Macías-Amezcua, Michel Dassaejv; García-Rentería, Jesús; Rendón-Félix, Jorge; Chávez-Tostado, Mariana; Cuesta-Márquez, Lizbeth Araceli; Alvarez-Villaseñor, Andrea Socorro; Cortés-Flores, Ana Olivia; González-Ojeda, Alejandro

2015-06-07

To determine whether or not the use of antioxidant supplementation aids in the prevention of post- endoscopic retrograde cholangiopancreatography pancreatitis. A systematic review of randomized controlled trials (RCTs) was made to evaluate the preventive effect of prophylactic antioxidant supplementation in post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP). The inclusion criteria included: acute post-endoscopic retrograde cholangiopancreatography pancreatitis in adults; randomized clinical trials with the use of any antioxidant as an intervention compared with placebo, to reduce PEP. The outcome measure was the incidence and severity of PEP. Twelve RCTs involving 3110 patients since 1999 were included. The antioxidants used were selenite, β-carotene, and pentoxifylline (each one in one trial), N-acetylcysteine (NAC) in three trials, and allopurinol in six trials. The group of patients treated with NAC received different doses; either oral or intravenous, and allopurinol-treated patients received five different oral doses in two different administration periods. The results are expressed with raw numbers, proportions, as well as mean and standard deviations. The incidence of pancreatitis between groups was analyzed with Pearson's χ(2) test or Fisher's exact test (F). The main outcome is expressed as relative risks and 95%CI. The incidence of pancreatitis in all antioxidant treatment groups was 8.6%, whereas it was 9.7% in the control group. The antioxidants used were selenite, β-carotene, and pentoxifylline (each one in one trial), NAC in three trials, and allopurinol in six trials. In allopurinol trials, three different dosifications were used; two trials reported a low dosage (of less than 400 mg), two trials reported a moderate dose (600 mg) and the remaining two employed higher doses (more than 900 mg). Supplementation was not associated with a significant reduction in the incidence of PEP [relative risk (RR) = 0.93; 95%CI: 0.82-1.06; P

Randomized Evaluation of Cognitive-Behavioral Therapy and Graded Exercise Therapy for Post-Cancer Fatigue.

Science.gov (United States)

Sandler, Carolina X; Goldstein, David; Horsfield, Sarah; Bennett, Barbara K; Friedlander, Michael; Bastick, Patricia A; Lewis, Craig R; Segelov, Eva; Boyle, Frances M; Chin, Melvin T M; Webber, Kate; Barry, Benjamin K; Lloyd, Andrew R

2017-07-01

Cancer-related fatigue is prevalent and disabling. When persistent and unexplained, it is termed post-cancer fatigue (PCF). Cognitive behavioral therapy (CBT) and graded exercise therapy (GET) may improve symptoms and functional outcomes. To evaluate the outcomes of a randomized controlled trial, which assigned patients with post-cancer fatigue to education, or 12 weeks of integrated cognitive-behavioral therapy (CBT) and graded exercise therapy (GET). Three months after treatment for breast or colon cancer, eligible patients had clinically significant fatigue, no comorbid medical or psychiatric conditions that explained the fatigue, and no evidence of recurrence. The CBT/GET arm included individually tailored consultations at approximately two weekly intervals. The education arm included a single visit with clinicians describing the principles of CBT/GET and a booklet. The primary outcome was clinically significant improvement in self-reported fatigue (Somatic and Psychological HEalth REport 0-12), designated a priori as greater than one SD of improvement in fatigue score. The secondary outcome was associated improvement in function (role limitation due to physical health problems-36-Item Short Form Health Survey 0-100) comparing baseline, end treatment (12 weeks), and follow-up (24 weeks). There were 46 patients enrolled, including 43 women (94%), with a mean age of 51 years. Fatigue severity improved in all subjects from a mean of 5.2 (±3.1) at baseline to 3.9 (±2.8) at 12 weeks, suggesting a natural history of improvement. Clinically significant improvement was observed in 7 of 22 subjects in the intervention group compared with 2 of 24 in the education group (P < 0.05, χ 2 ). These subjects also had improvement in functional status compared with nonresponders (P < 0.01, t-test). Combined CBT/GET improves fatigue and functional outcomes for a subset of patients with post-cancer fatigue. Further studies to improve the response rate and the magnitude of

FIFTEEN-YEAR RADIOTHERAPY OUTCOMES OF THE RANDOMIZED PORTEC-1 TRIAL FOR ENDOMETRIAL CARCINOMA

NARCIS (Netherlands)

Creutzberg, Carien L.; Nout, Remi A.; Lybeert, Marnix L. M.; Warlam-Rodenhuis, Carla C.; Jobsen, Jan J.; Mens, Jan-Willem M.; Lutgens, Ludy C. H. W.; Pras, Elisabeth; van de Poll-Franse, Lonneke V.; van Putten, Wim L. J.

2011-01-01

Purpose: To evaluate the very long-term results of the randomized Post Operative Radiation Therapy in Endometrial Carcinoma (PORTEC)-1 trial for patients with Stage I endometrial carcinoma (EC), focusing on the role of prognostic factors for treatment selection and the long-term risk of second

The Evaluation of Yellow vs. Blue Color Contrast Sensitivity pre and Post LASIK

Directory of Open Access Journals (Sweden)

S. Heydarian

2007-06-01

Full Text Available Introduction: contrast sensitivity is one of the most important psychophysical tests that may be used for the evaluation of refractive state of eye and retinal image quality. Yellow vs. blue color contrast sensitivity may be more suitable in this regard. Materials and Methods: thirty myopic eyes were considered in this study. Yellow vs. blue color contrast sensitivity was evaluated under the same environment and conditions in these individuals pre and post LASIK. Results: The comparison of yellow vs. blue color contrast sensitivity with glasses pr e and post LASIK shows a significant improvement (p

Event-Related Potentials for Post-Error and Post-Conflict Slowing

Science.gov (United States)

Chang, Andrew; Chen, Chien-Chung; Li, Hsin-Hung; Li, Chiang-Shan R.

2014-01-01

In a reaction time task, people typically slow down following an error or conflict, each called post-error slowing (PES) and post-conflict slowing (PCS). Despite many studies of the cognitive mechanisms, the neural responses of PES and PCS continue to be debated. In this study, we combined high-density array EEG and a stop-signal task to examine event-related potentials of PES and PCS in sixteen young adult participants. The results showed that the amplitude of N2 is greater during PES but not PCS. In contrast, the peak latency of N2 is longer for PCS but not PES. Furthermore, error-positivity (Pe) but not error-related negativity (ERN) was greater in the stop error trials preceding PES than non-PES trials, suggesting that PES is related to participants' awareness of the error. Together, these findings extend earlier work of cognitive control by specifying the neural correlates of PES and PCS in the stop signal task. PMID:24932780

A randomised controlled trial of a cognitive behavioural intervention for women who have menopausal symptoms following breast cancer treatment (MENOS 1: Trial protocol

Directory of Open Access Journals (Sweden)

Hellier Jennifer

2011-01-01

Full Text Available Abstract Background This trial aims to evaluate the effectiveness of a group cognitive behavioural intervention to alleviate menopausal symptoms (hot flushes and night sweats in women who have had breast cancer treatment. Hot flushes and night sweats are highly prevalent but challenging to treat in this population. Cognitive behaviour therapy has been found to reduce these symptoms in well women and results of an exploratory trial suggest that it might be effective for breast cancer patients. Two hypotheses are tested: Compared to usual care, group cognitive behavioural therapy will: 1. Significantly reduce the problem rating and frequency of hot flushes and nights sweats after six weeks of treatment and at six months post-randomisation. 2. Improve mood and quality of life after six weeks of treatment and at six months post-randomisation. Methods/Design Ninety-six women who have completed their main treatment for breast cancer and who have been experiencing problematic hot flushes and night sweats for over two months are recruited into the trial from oncology and breast clinics in South East London. They are randomised to either six weekly group cognitive behavioural therapy (Group CBT sessions or to usual care. Group CBT includes information and discussion about hot flushes and night sweats in the context of breast cancer, monitoring and modifying precipitants, relaxation and paced respiration, stress management, cognitive therapy for unhelpful thoughts and beliefs, managing sleep and night sweats and maintaining changes. Prior to randomisation women attend a clinical interview, undergo 24-hour sternal skin conductance monitoring, and complete questionnaire measures of hot flushes and night sweats, mood, quality of life, hot flush beliefs and behaviours, optimism and somatic amplification. Post-treatment measures (sternal skin conductance and questionnaires are collected six to eight weeks later and follow-up measures (questionnaires and a use

The patient's safety and access to experimental drugs after the termination of clinical trials: regulations and trends.

Science.gov (United States)

da Silva, Ricardo Eccard; Amato, Angélica Amorim; Sousa, Thiago do Rego; de Carvalho, Marta Rodrigues; Novaes, Maria Rita Carvalho Garbi

2018-05-12

Participants' rights and safety must be guaranteed not only while a clinical trial is being conducted but also when a clinical trial finishes. The criteria for post-trial access to experimental drugs, however, are unclear in various countries. The objectives of this study were (i) to ascertain if there were regulations or guidelines related to patients' access to drugs after the end of clinical trials in the countries selected in the study and (ii) to analyze trends in post-trial access in countries classified by their level of economic development. This study is a retrospective review. The data are from the records of clinical trials from 2014 registered in the World Health Organization's International Clinical Trials Registry Platform (ICTRP) database. Among the countries selected, provision of drugs post-trial is mandatory only in Argentina, Brazil, Chile, Finland, and Peru. The plans for post-trial access tend to be more present in low- and middle-income and upper middle-income countries, in comparison with high-income countries. Studies involving vulnerable populations are 2.53 times more likely to have plans for post-trial access than studies which do not. The guaranteeing of post-trial access remains mandatory in few countries. Considering that individuals seen as vulnerable have been included in clinical trials without plans for post-trial access, stakeholders must discuss the need to develop regulations mandating the guaranteeing of post-trial access in specified situations.

The Australasian Resuscitation in Sepsis Evaluation (ARISE) trial statistical analysis plan.

Science.gov (United States)

Delaney, Anthony P; Peake, Sandra L; Bellomo, Rinaldo; Cameron, Peter; Holdgate, Anna; Howe, Belinda; Higgins, Alisa; Presneill, Jeffrey; Webb, Steve

2013-09-01

The Australasian Resuscitation in Sepsis Evaluation (ARISE) study is an international, multicentre, randomised, controlled trial designed to evaluate the effectiveness of early goal-directed therapy compared with standard care for patients presenting to the emergency department with severe sepsis. In keeping with current practice, and considering aspects of trial design and reporting specific to non-pharmacological interventions, our plan outlines the principles and methods for analysing and reporting the trial results. The document is prepared before completion of recruitment into the ARISE study, without knowledge of the results of the interim analysis conducted by the data safety and monitoring committee and before completion of the two related international studies. Our statistical analysis plan was designed by the ARISE chief investigators, and reviewed and approved by the ARISE steering committee. We reviewed the data collected by the research team as specified in the study protocol and detailed in the study case report form. We describe information related to baseline characteristics, characteristics of delivery of the trial interventions, details of resuscitation, other related therapies and other relevant data with appropriate comparisons between groups. We define the primary, secondary and tertiary outcomes for the study, with description of the planned statistical analyses. We have developed a statistical analysis plan with a trial profile, mock-up tables and figures. We describe a plan for presenting baseline characteristics, microbiological and antibiotic therapy, details of the interventions, processes of care and concomitant therapies and adverse events. We describe the primary, secondary and tertiary outcomes with identification of subgroups to be analysed. We have developed a statistical analysis plan for the ARISE study, available in the public domain, before the completion of recruitment into the study. This will minimise analytical bias and

The Hip Fracture Surgery in Elderly Patients (HIPELD study: protocol for a randomized, multicenter controlled trial evaluating the effect of xenon on postoperative delirium in older patients undergoing hip fracture surgery

Directory of Open Access Journals (Sweden)

Coburn Mark

2012-09-01

Full Text Available Abstract Background Strategies to protect the brain from postoperative delirium (POD after hip fracture are urgently needed. The development of delirium often is associated with the loss of independence, poor functional recovery, and increased morbidity, as well as increases in length of hospital stay, discharges to nursing facilities, and healthcare costs. We hypothesize that xenon may reduce the burden of POD, (i by avoiding the need to provide anesthesia with a drug that targets the γ-amino-butyric acid (GABAA receptor and (ii through beneficial anesthetic and organ-protective effects. Methods and design An international, multicenter, phase 2, prospective, randomized, blinded, parallel group and controlled trial to evaluate the incidence of POD, diagnosed with the Confusion Assessment Method (CAM, in older patients undergoing hip fracture surgery under general anesthesia with xenon or sevoflurane, for a period of 4 days post surgery (primary outcome is planned. Secondary objectives are to compare the incidence of POD between xenon and sevoflurane, to evaluate the incidence of POD from day 5 post surgery until discharge from hospital, to determine the time to first POD diagnosis, to evaluate the duration of POD, to evaluate the evolution of the physiological status of the patients in the postoperative period, to evaluate the recovery parameters, to collect preliminary data to evaluate the economical impact of POD in the postoperative period and to collect safety data. Patients are eligible if they are older aged (≥ 75 years and assigned to a planned hip fracture surgery within 48 h after the hip fracture. Furthermore, patients need to be willing and able to complete the requirements of this study including the signature of the written informed consent. A total of 256 randomized patients in the 10 participating centers will be recruited, that is, 128 randomized patients in each of the 2 study groups (receiving either xenon or sevoflurane

Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial.

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Glazener, Cathryn; Constable, Lynda; Hemming, Christine; Breeman, Suzanne; Elders, Andrew; Cooper, Kevin; Freeman, Robert; Smith, Anthony R B; Hagen, Suzanne; McDonald, Alison; McPherson, Gladys; Montgomery, Isobel; Kilonzo, Mary; Boyers, Dwayne; Goulao, Beatriz; Norrie, John

2016-09-08

One in three women who have a prolapse operation will go on to have another operation, though not necessarily in the same compartment. Surgery can result in greater impairment of quality of life than the original prolapse itself (such as the development of new-onset urinary incontinence, or prolapse at a different site). Anterior and posterior prolapse surgery is most common (90 % of operations), but around 43 % of women also have a uterine (34 %) or vault (9 %) procedure at the same time. There is not enough evidence from randomised controlled trials (RCTs) to guide management of vault or uterine prolapse. The Vault or Uterine prolapse surgery Evaluation (VUE) study aims to assess the surgical management of upper compartment pelvic organ prolapse (POP) in terms of clinical effectiveness, cost-effectiveness and adverse events. VUE is two parallel, pragmatic, UK multicentre, RCTs (Uterine Trial and Vault Trial). Eligible for inclusion are women with vault or uterine prolapse: requiring a surgical procedure, suitable for randomisation and willing to be randomised. Randomisation will be computer-allocated separately for each trial, minimised on: requiring concomitant anterior and/or posterior POP surgery or not, concomitant incontinence surgery or not, age (under 60 years or 60 years and older) and surgeon. Participants will be randomly assigned, with equal probability to intervention or control arms in either the Uterine Trial or the Vault Trial. Uterine Trial participants will receive either a vaginal hysterectomy or a uterine preservation procedure. Vault Trial participants will receive either a vaginal sacrospinous fixation or an abdominal sacrocolpopexy. Participants will be followed up by postal questionnaires (6 months post surgery and 12 months post randomisation) and also reviewed in clinic 12 months post surgery. The primary outcome is the participant-reported Pelvic Organ Prolapse Symptom Score (POP-SS) at 12 months post randomisation

FDG PET as a prognostic predictor in the early post-therapeutic evaluation for unresectable hepatocellular carcinoma

Energy Technology Data Exchange (ETDEWEB)

Higashi, Tatsuya; Nishii, Ryuichi [Shiga Medical Center Research Institute, Moriyama City, Shiga (Japan); Hatano, Etsuro; Ikai, Iwao; Seo, Satoru; Kitamura, Koji; Takada, Yasuji; Kamimoto, Shinji [Kyoto University Graduate School of Medicine, Department of Gastroenterological Surgery, Sakyo-ku, Kyoto (Japan); Nakamoto, Yuji; Ishizu, Koichi; Suga, Tsuyoshi; Kawashima, Hidekazu; Togashi, Kaori [Kyoto University Graduate School of Medicine, Department of Diagnostic Imaging and Nuclear Medicine, Sakyo-ku, Kyoto (Japan)

2010-03-15

To elucidate the prognostic role of post-therapeutic {sup 18}F-fluorodeoxyglucose ({sup 18}F-FDG) positron emission tomography (PET), we conducted a retrospective cohort study analysing the clinical factors that affect overall survival after non-operative therapy for unresectable hepatocellular carcinoma (HCC). Sixty-seven cases with unresectable HCC who received non-operative therapy (transcatheter arterial chemoembolization: n=24, transcatheter arterial infusion chemotherapy: n=31, radiofrequency ablation: n = 5 or systemic chemotherapy: n = 7) and had received FDG PET for the evaluation of the therapeutic effect within 1 month after the end of the therapy were evaluated. Overall survival rate was evaluated using the univariate and multivariate analyses of relevant clinical and laboratory parameters before and after therapy, including visual PET analysis and quantitative analysis using maximum standardized uptake value (SUV). Visual PET diagnosis of post-therapeutic lesions was a good predictor of overall survival of unresectable HCC patients. The low FDG group showed significantly longer survival (average: 608 days) than that (average: 328 days) of the high FDG group (p<0.0001). Multivariate analysis showed four significant prognostic factors for the survival: post-therapeutic alpha-fetoprotein ({alpha}FP) level (=400 ng/ml, p=0.004), post-therapeutic visual PET diagnosis (p=0.006), post-therapeutic clinical stage (UICC stage IV, p=0.04) and post-therapeutic Milan criteria (p=0.03), while pre-therapeutic clinical factors, SUV by post-therapeutic FDG PET (5.0 or more) or others did not show significance. The present study suggests that post-therapeutic PET performed within 1 month after non-operative therapy can be a good predictor of overall survival in unresectable HCC patients, while pre-therapeutic evaluation including PET, tumour markers and clinical staging may not be useful. (orig.)

[Research about re-evaluation of screening of traditonal Chinese medicine symptoms item of post-marketing medicine Xuezhikang].

Science.gov (United States)

He, Wei; Xie, Yanming; Wang, Yongyan

2011-10-01

The purpose of post-marketing Chinese medicine re-evaluation is to identify Chinese medicine clinical indications, while designing scientific and rational of Chinese medicine symptoms items are important to the result of symptoms re-evaluation. This study give screening of traditional Chinese medicine(TCM) symptoms item of post-marketing medicine Xuezhikang re-evaluation as example that reference to principle dyslipidemia clinical research, academic dissertations, Xuezhikang directions, clinical expert practice experience etc. while standardization those symptom names and screening 41 dyslipidemia common symptoms. Furthermore, this paper discuss about the accoerdance and announcements when screening symptoms item, so as to providing a research thread to manufacture PRO chart for post-marketing medicine re-evaluation.

BLIND TRIALS EVALUATING IN VITRO INFECTIVITY OF CRYPTOSPORIDIUM PARVUM OOCYSTS USING CELL CULTURE IMMUNOFLUORESCENCE

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An optimized cell culture-immunofluorescence (IFA) procedure, using the HCT-8 cell line, was evaluated in 'blind' trials to determine the sensitivity and reproducibility for measuring infectivity of flow cytometry prepared inocula of C. parvum oocysts. In separate trials, suspens...

Understanding influences on teachers' uptake and use of behaviour management strategies within the STARS trial: process evaluation protocol for a randomised controlled trial.

Science.gov (United States)

Hansford, Lorraine; Sharkey, Siobhan; Edwards, Vanessa; Ukoumunne, Obioha; Byford, Sarah; Norwich, Brahm; Logan, Stuart; Ford, Tamsin

2015-02-10

The 'Supporting Teachers And childRen in Schools' (STARS) study is a cluster randomised controlled trial evaluating the Incredible Years Teacher Classroom Management (TCM) programme as a public health intervention. TCM is a 6 day training course delivered to groups of 8-12 teachers. The STARS trial will investigate whether TCM can improve children's behaviour, attainment and wellbeing, reduce teachers' stress and improve their self-efficacy. This protocol describes the methodology of the process evaluation embedded within the main trial, which aims to examine the uptake and implementation of TCM strategies within the classroom plus the wider school environment and improve the understanding of outcomes. The STARS trial will work with eighty teachers of children aged 4-9 years from eighty schools. Teachers will be randomised to attend the TCM course (intervention arm) or to "teach as normal" (control arm) and attend the course a year later. The process evaluation will use quantitative and qualitative approaches to assess fidelity to model, as well as explore headteachers' and teachers' experiences of TCM and investigate school factors that influence the translation of skills learnt to practice. Four of the eight groups of teachers (n = 40) will be invited to participate in focus groups within one month of completing the TCM course, and again a year later, while 45 of the 80 headteachers will be invited to take part in telephone interviews. Standardised checklists will be completed by group leaders and each training session will be videotaped to assess fidelity to model. Teachers will also complete standardised session evaluations. This study will provide important information about whether the Teacher Classroom Management course influences child and teacher mental health and well-being in both the short and long term. The process evaluation will provide valuable insights into factors that may facilitate or impede any impact. The trial has been registered with ISCTRN

[Strategy of constructing post-market integral evaluation system of traditional Chinese medicine injection].

Science.gov (United States)

Zhang, Xiao-Yu; Wang, Yan-Ping; Lin, Li-Kai; Shang, Hong-Cai; Wang, Yong-Yan

2017-08-01

As an important representative of modern Chinese medicine, traditional Chinese medicine (TCM) injzection has become an indispensable part of the Chinese medicine industry. However, its development is now restricted by the bottleneck of insufficient core competitiveness, low-level research and production, even injection quality and the safe use are not guaranteed. Thus, it is urgent to reevaluate post-marketing TCM injection generally and to make secondary development. Under current circumstances, taking major brands which have good clinical and market foundation, as well as research value, as the main subject of cultivation and evaluation is an important approach to innovative development of TCM injection industry. Unlike oral proprietary Chinese medicine, the cultivatation of major brands of TCM injection needs higher technical support, quality standards and more timely feedback. Therefore, a post-market integral evaluation system adaptive to TCM injection is required. This article discussed some key points on the construction of a post-market integral evaluation system of TCM injection in three levels： optimizing evaluation methods, building synergistic innovation platforms which combine the medical research institutions and pharmaceutical enterprises, and finally constructing the integral evaluation system. A "five to one" structure has been proposed to enhance TCM injection effectiveness, safety and adaptability on the whole, which are from the following aspects： mechanism research, clinical evidence validation, literature information mining, sustainable development of resources and industrialization operation. Copyright© by the Chinese Pharmaceutical Association.

A randomized controlled trial of vitamin D supplementation on perinatal depression: in Iranian pregnant mothers

OpenAIRE

Vaziri, Farideh; Nasiri, Samira; Tavana, Zohreh; Dabbaghmanesh, Mohammad Hossein; Sharif, Farkhondeh; Jafari, Peyman

2016-01-01

Background Mood disorders in pregnancy and post-partum period are common and considered as a public health issue. Researchers have studied the relationship between low serum vitamin D concentration and perinatal depression, although no clinical trial has been conducted on vitamin D?s effects on depression related to childbirth. This study evaluated the effect of vitamin D3 supplementation on perinatal depression scores. Methods This randomized clinical trial was done in pregnant women who wer...

A randomized clinical trial of methadone maintenance for prisoners: findings at 6 months post-release.

Science.gov (United States)

Gordon, Michael S; Kinlock, Timothy W; Schwartz, Robert P; O'Grady, Kevin E

2008-08-01

This study examined the effectiveness of methadone maintenance initiated prior to or just after release from prison at 6 months post-release. A three-group randomized controlled trial was conducted between September 2003 and June 2005. A Baltimore pre-release prison. Two hundred and eleven adult pre-release inmates who were heroin-dependent during the year prior to incarceration. Participants were assigned randomly to the following: counseling only: counseling in prison, with passive referral to treatment upon release (n = 70); counseling + transfer: counseling in prison with transfer to methadone maintenance treatment upon release (n = 70); and counseling + methadone: methadone maintenance and counseling in prison, continued in a community-based methadone maintenance program upon release (n = 71). Addiction Severity Index at study entry and follow-up. Additional assessments at 6 months post-release were treatment record review; urine drug testing for opioids, cocaine and other illicit drugs. Counseling + methadone participants were significantly more likely than both counseling only and counseling + transfer participants to be retained in drug abuse treatment (P = 0.0001) and significantly less likely to have an opioid-positive urine specimen compared to counseling only (P = 0.002). Furthermore, counseling + methadone participants reported significantly fewer days of involvement in self-reported heroin use and criminal activity than counseling only participants. Methadone maintenance, initiated prior to or immediately after release from prison, increases treatment entry and reduces heroin use at 6 months post-release compared to counseling only. This intervention may be able to fill an urgent treatment need for prisoners with heroin addiction histories.

Study on post-earthquake plant evaluation and communication (Annual safety research report, JFY 2010)

International Nuclear Information System (INIS)

Iijima, Toru; Taoka, Hideto; Yamada, Hiroyuki; Sano, Kyoko

2011-01-01

The aims of this study are to establish a post-earthquake plant evaluation method and to develop a communication system for the improving seismic safety regulations as well as encouraging public communication. The Miyagiken-oki earthquake in 2005, Onagawa Nuclear Power Plant shut down automatically. Subsequently, JNES started development of post-earthquake plant evaluation and communication system based on the experience of the cross-check analysis for Onagawa Nuclear Power Plant. The Niigata-ken Chuetsu-oki Earthquake in 2007, the plant situation was not transmitted promptly. The loss of information sharing between local community and related organizations caused the public anxiety. The importance of plant information transmission as well as seismic information gathering were recognized. The proposal for the solution of the information issues were performed by government committee. In this study, the evaluation method for soundness of the main structure and equipment after earthquake event were updated. Moreover, procedure of the post-earthquake plant soundness evaluation and multi-functional seismic information system were developed. In addition, the implementation strategy of the easy-to -understand information dissemination to the public and transparent communication methodology was examined by the Industry-Academia-Government cooperation in the Kashiwazaki-Kariwa region. (author)

Modern indications for post-mastectomy radiotherapy application

International Nuclear Information System (INIS)

Parvanova, V.

2002-01-01

Before the effective adjuvant chemotherapy, post-mastectomy chemotherapy was usually used in breast cancer patients. The interest in this approach was revived after a number of studies were successful in identifying patient subgroups with 20 and 40 percent of locoregional relapses following mastectomy and chemotherapy. These subgroups including women presenting 4 and more positive lymph odes or an advanced primary tumor (measuring 5 cm or more, or a neoplasm invading skin or contiguous musculature) are taken to be the most likely to benefit from a course od post-mastectomy radiotherapy. Recent randomized trials demonstrate adequate tumor control and heightened overall survival rates when mastectomy is supplemented by radiotherapy. A currently performed meta-analysis of over 22000 women comparing groups with and without adjuvant radiotherapy point to an improvement in locoregional tumor control rates from 70 to 90 percent. The result of a 20-year follow-up study document a significant improvement of overall and disease-specific survivalship. These are findings lending support to the concept that improving locoregional tumor control rates in breast cancer may account for an increase of overall survivorship. Regardless of a rather short follow-up of women undergoing updated radiotherapy techniques, the preliminary results do not show increased incidence of vascular death, but pos-mastectomy radiotherapy continues to be associated with an elevated hand edema risk. For the time being, the role of post-mastectomy radiotherapy in women presenting 1 to 3 positive axillary lymph nodes remains not well enough clarified, and needs further evaluation in randomized clinical trials. (authors)

Defendant's or convict's competency to stand trial - forensic psychiatric evaluation.

Science.gov (United States)

Cynkier, Przemysław N

2017-01-01

The purpose of this paper was to draw attention to particularly important aspects of pronouncing forensic psychiatric judgment regarding the accused or convicted individuals' competency to stand trial. The level of a person's mental capacity should be established using a structured psychiatric interview concerning a variety of aspects of a trial. Emphasis should be placed on evaluating the defendant's consciousness of the charges, knowledge of the potential punishment, ability to make significant decisions and be engaged in defense, knowledge about the role that particular people present in the courtroom play, understanding of the meaning of the evidence gathered in the case, the risk of aggression. The analysis should take into account the specificity of the mental disorder, the influence of proceedings on the course of disorder, as well as the presence of reactive disorders. Using testing tools by the expert can facilitate the process of evaluation to a certain degree. Forensic psychiatric evaluations can give rise to difficulties for the experts, what with the changing legal regulations and their interpretations. It would be justified to develop the standards of evaluation in this kind of cases, which would on the one hand apply to experts but which would also be respected by the judicial organ.

Evaluation of the Utility of a Discrete-Trial Functional Analysis in Early Intervention Classrooms

Science.gov (United States)

Kodak, Tiffany; Fisher, Wayne W.; Paden, Amber; Dickes, Nitasha

2013-01-01

We evaluated a discrete-trial functional analysis implemented by regular classroom staff in a classroom setting. The results suggest that the discrete-trial functional analysis identified a social function for each participant and may require fewer staff than standard functional analysis procedures.

Randomized Controlled Evaluation of an Early Intervention to Prevent Post-Rape Psychopathology

OpenAIRE

Resnick, Heidi; Acierno, Ron; Waldrop, Angela E.; King, Lynda; King, Daniel; Danielson, Carla; Ruggiero, Kenneth J.; Kilpatrick, Dean

2007-01-01

A randomized between-group design was used to evaluate efficacy of a video intervention to reduce PTSD and other mental health problems, implemented prior to the forensic medical exam conducted within 72 hours post-sexual assault. Participants were 140 female victims of sexual assault (68 video/72 nonvideo) ages 15 or older. Assessments were targeted for 6 weeks (Time 1) and 6 months (Time 2) post-assault. At Time 1, the intervention was associated with lower scores on measures of PTSD and de...

Designing and evaluating the effectiveness of a serious game for safe administration of blood transfusion: A randomized controlled trial.

Science.gov (United States)

Tan, Apphia Jia Qi; Lee, Cindy Ching Siang; Lin, Patrick Yongxing; Cooper, Simon; Lau, Lydia Siew Tiang; Chua, Wei Ling; Liaw, Sok Ying

2017-08-01

Preparing nursing students for the knowledge and skills required for the administration and monitoring of blood components is crucial for entry into clinical practice. Serious games create opportunities to develop this competency, which can be used as a self-directed learning strategy to complement existing didactic learning and simulation-based strategies. To describe the development and evaluation of a serious game to improve nursing students' knowledge, confidence, and performance in blood transfusion. An experiential gaming model was applied to guide the design of the serious game environment. A clustered, randomized controlled trial was conducted with 103 second-year undergraduate nursing students who were randomized into control or experimental groups. After a baseline evaluation of the participants' knowledge and confidence on blood transfusion procedure, the experimental group undertook a blood transfusion serious game and completed a questionnaire to evaluate their learning experience. All participants' clinical performances were evaluated in a simulated environment. The post-test knowledge and confidence mean scores of the experimental group improved significantly (pgame intervention compared to pre-test mean scores and to post-test mean scores of the control group (pgame positively. The study provided evidence on the effectiveness of a serious game in improving the knowledge and confidence of nursing students on blood transfusion practice. The features of this serious game could be further developed to incorporate additional scenarios with repetitive exercises and feedback to enhance the impact on clinical performance. Given the flexibility, practicality, and scalability of such a game, they can serve as a promising approach to optimize learning when blended with high-fidelity simulation. Copyright © 2017. Published by Elsevier Ltd.

Evaluating feasibility and acceptability of a local psycho-educational intervention for pregnant women with common mental problems affected by armed conflict in Swat, Pakistan: A parallel randomized controlled feasibility trial.

Science.gov (United States)

Khan, Muhammad Naseem; Dherani, Mukesh; Chiumento, Anna; Atif, Najia; Bristow, Katie; Sikander, Siham; Rahman, Atif

2017-12-01

The current research was conducted in the Swat valley, where widespread conflict and militancy had been experienced prior to the field activities. The aim of this trial was to evaluate the feasibility and acceptability of a locally developed psycho-educational intervention. This mixed-methods study incorporated a quantitative and qualitative component. For the quantitative component, trial participants were identified from a cross-sectional study conducted in the earlier phase of the research, with Self-Reporting Questionnaire (SRQ) score of ≥9. Participants with suicidal ideation, severe mental or medical illness, recently given birth or living with another woman with an SRQ score of 9 or above were excluded. Participants fulfilling eligibility were randomized on a 1:1 allocation ratio using simple randomization to the psycho-educational intervention or routine care arm. The intervention arm received two psycho-educational sessions at their homes delivered by local community health worker from the study area. The primary outcome was help-seeking for psychological distress, measured by a semi-structured interview by a researcher blind to the allocation status at 2 months post-intervention. Secondary outcomes include psychological distress and social support measured by SRQ and Multidimensional Scale of Perceived Social Support (MSPSS), respectively, at 2 months post-intervention. Intervention acceptability was explored through in-depth interviews. Local community health workers with no mental health experience successfully delivered the psycho-educational sessions in the community. The uptake of intervention was good and the intervention was taken well by the families and the community health workers. The outcome evaluation was not powered; however, more women sought assistance for their distress from their community health workers in the intervention arm, compared to women in the control arm. This trial showed good acceptance and feasible delivery of a

A systems biology approach investigating the effect of probiotics on the vaginal microbiome and host responses in a double blind, placebo-controlled clinical trial of post-menopausal women.

Directory of Open Access Journals (Sweden)

Jordan E Bisanz

Full Text Available A lactobacilli dominated microbiota in most pre and post-menopausal women is an indicator of vaginal health. The objective of this double blinded, placebo-controlled crossover study was to evaluate in 14 post-menopausal women with an intermediate Nugent score, the effect of 3 days of vaginal administration of probiotic L. rhamnosus GR-1 and L. reuteri RC-14 (2.5×109 CFU each on the microbiota and host response. The probiotic treatment did not result in an improved Nugent score when compared to when placebo. Analysis using 16S rRNA sequencing and metabolomics profiling revealed that the relative abundance of Lactobacillus was increased following probiotic administration as compared to placebo, which was weakly associated with an increase in lactate levels. A decrease in Atopobium was also observed. Analysis of host responses by microarray showed the probiotics had an immune-modulatory response including effects on pattern recognition receptors such as TLR2 while also affecting epithelial barrier function. This is the first study to use an interactomic approach for the study of vaginal probiotic administration in post-menopausal women. It shows that in some cases multifaceted approaches are required to detect the subtle molecular changes induced by the host to instillation of probiotic strains.ClinicalTrials.gov NCT02139839.

'Beyond Milestones': a randomised controlled trial evaluating an innovative digital resource teaching quality observation of normal child development.

Science.gov (United States)

Connolly, Anne M; Cunningham, Clare; Sinclair, Adriane J; Rao, Arjun; Lonergan, Amy; Bye, Ann M E

2014-05-01

The study aimed to create and evaluate the educational effectiveness of a digital resource instructing paediatric trainees in a systematic approach to critical and quality observation of normal child development. A digital educational resource was developed utilising the skills of an expert developmental paediatrician who was videoed assessing normal early child development at a series of critical stages. Videos illustrated aspects of language, sophistication of play and socialisation, cognition, and motor progress. Expert commentary, teaching text and summaries were used. A randomised controlled trial evaluated the resource. Paediatric trainees were recruited from The Sydney Children's Hospitals Network. Outcome measures were repeated at three time points (pre-teaching, immediate-post and 1 month) and included self-rated attitudes, knowledge of markers of development and observational expertise. Qualitative data on teaching usefulness were obtained through open-ended questions. Fifty-six paediatric trainees (registrar 79%, women 82%; mean age 31 years) completed the pre-assessment, 46 the immediate-post and 45 the 1-month follow-up (20% attrition). Compared with the Control group, the Teaching group scored higher over time on markers of development (P = 0.006), observational expertise (P improves knowledge, increases confidence and is useful, providing a structured approach to developmental assessment. The techniques taught can be applied to every paediatric consultation. © 2013 The Authors. Journal of Paediatrics and Child Health © 2013 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

Investigating the key indicators for evaluating post-disaster shelter.

Science.gov (United States)

Nath, Ronita; Shannon, Harry; Kabali, Conrad; Oremus, Mark

2017-07-01

This study sought to identify the primary indicators for evaluating shelter assistance following natural disasters and then to develop a shelter evaluation instrument based on these indicators. Electronic databases and the 'grey' literature were scoured for publications with a relation to post-disaster shelter assistance. Indicators for evaluating such assistance were extracted from these publications. In total, 1,525 indicators were extracted from 181 publications. A preliminary evaluation instrument was designed from these 1,525 indicators. Shelter experts checked the instrument for face and content validity, and it was revised subsequently based on their input. The revised instrument comprises a version for use by shelter agencies (48 questions that assess 23 indicators) and a version for use by beneficiaries (52 questions that assess 22 indicators). The instrument can serve as a standardised tool to enable groups to gauge whether or not the shelter assistance that they supply meets the needs of disaster-affected populations. © 2017 The Author(s). Disasters © Overseas Development Institute, 2017.

Gadobutrol for contrast-enhanced magnetic resonance imaging in elderly patients: review of the safety profile from clinical trial, post-marketing surveillance, and pharmacovigilance data

International Nuclear Information System (INIS)

Endrikat, J.; Schwenke, C.; Prince, M.R.

2015-01-01

Aim: To assess the safety of gadobutrol administration in elderly patients (≥65 years) by comparing the incidence of adverse drug reactions (ADRs) following gadobutrol-enhanced magnetic resonance imaging (MRI) procedures in elderly patients with that in adults aged 18–64 years. Materials and methods: Safety data on gadobutrol administration from clinical trials, post-marketing surveillance (PMS) studies, and pharmacovigilance reports were collected in three databases. In each dataset, absolute and relative frequencies of ADRs between age groups were analysed, along with odds ratios and 95% confidence intervals. Logistic regression was used to identify significant influencing factors on ADRs in the PMS and pharmacovigilance data. Results: Rates of reported ADRs were lower in elderly patients versus adults aged <65 years due to a reduced incidence of non-serious ADRs; this was statistically significant for the clinical trials and pharmacovigilance populations, with a trend in the PMS database. Serious ADRs occurred infrequently in the clinical trials and PMS populations (too low for statistical comparison), and pharmacovigilance data demonstrated a low incidence (<0.005%) in both age groups. Conclusions: This evaluation involving three large databases demonstrated no greater incidence of ADRs following gadobutrol-enhanced MRI in elderly patients (≥65 years) compared with younger adults, with gadobutrol having a favourable safety profile in both age groups. -- Highlights: •First dedicated safety study of an extracellular contrast agent in the elderly. •Elderly patients experience fewer non-serious ADRs than younger adults. •Gadobutrol has a favourable safety profile in both age groups

Reporting and evaluation of HIV-related clinical endpoints in two multicenter international clinical trials

DEFF Research Database (Denmark)

Lifson, A; Rhame, F; Bellosa, W

2006-01-01

adjudication between reviewers before diagnostic certainty was assigned. CONCLUSION: Important requirements for HIV trials using clinical endpoints include objective definitions of "confirmed" and "probable," a formal reporting process with adequate information and supporting source documentation, evaluation......PURPOSE: The processes for reporting and review of progression of HIV disease clinical endpoints are described for two large phase III international clinical trials. METHOD: SILCAAT and ESPRIT are multicenter randomized HIV trials evaluating the impact of interleukin-2 on disease progression...... and death in HIV-infected patients receiving antiretroviral therapy. We report definitions used for HIV progression of disease endpoints, procedures for site reporting of such events, processes for independent review of reported events by an Endpoint Review Committee (ERC), and the procedure...

Microbicide clinical trial adherence: insights for introduction.

Science.gov (United States)

Woodsong, Cynthia; MacQueen, Kathleen; Amico, K Rivet; Friedland, Barbara; Gafos, Mitzy; Mansoor, Leila; Tolley, Elizabether; McCormack, Sheena

2013-04-08

After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1) Adherence measurement in clinical trials, (2) Comprehension of use instructions/Instructions for use, (3) Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4) Partner influence on use, (5) Retention and continuation and (6) Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs.

Using automated voice messages linked to telephone counselling to increase post-menstrual regulation contraceptive uptake and continuation in Bangladesh: study protocol for a randomised controlled trial.

Science.gov (United States)

Reiss, Kate; Andersen, Kathryn; Barnard, Sharmani; Ngo, Thoai D; Biswas, Kamal; Smith, Christopher; Carpenter, James; Church, Kathryn; Nuremowla, Sadid; Pearson, Erin

2017-10-03

Adoption of modern contraceptive methods after menstrual regulation (MR) is thought to reduce subsequent unwanted pregnancy and abortion. Long-acting reversible contraceptives (LARCs) are highly effective at reducing unintended pregnancy, but uptake in Bangladesh is low. Providing information on the most effective methods of contraception increases uptake of more effective methods. This protocol describes a randomised controlled trial of an intervention delivered by mobile phone designed to support post-MR contraceptive use in Bangladesh. This is a multi-site single blind individual randomised controlled trial. At least 960 women undergoing MR procedures at selected facilities will be recruited after their procedure by female research assistants. Women will be randomised into the control or intervention group with a 1:1 ratio. All participants will receive usual clinic care, including contraceptive counselling and the telephone number of a non-toll-free call centre which provides counselling on MR and contraception. During the 4 months after their MR procedure, intervention participants will be sent 11 recorded interactive voice messages to their mobile phone about contraception with a focus on their chosen method and LARCs. Each message allows the participant to connect directly to the call centre. The intervention is free to the user. The control group will receive no messages delivered by mobile phone. All participants will be asked to complete an in-person questionnaire at recruitment and follow-up questionnaires by telephone at 2 weeks, 4 months and 12 months after their MR. The primary outcome for the trial will be self-reported LARC use 4 months post-MR. Secondary outcomes include LARC use at 2 weeks and 12 months post-MR, use of any effective modern contraceptive method at 2 weeks, 4 months and 12 months post-MR, and contraceptive discontinuation, contraceptive method switching, pregnancy, subsequent MR and experience of violence during the 12�

The PD COMM trial: a protocol for the process evaluation of a randomised trial assessing the effectiveness of two types of SLT for people with Parkinson's disease.

Science.gov (United States)

Masterson-Algar, Patricia; Burton, Christopher R; Brady, Marian C; Nicoll, Avril; Clarke, Carl E; Rick, Caroline; Hughes, Max; Au, Pui; Smith, Christina H; Sackley, Catherine M

2017-08-29

The PD COMM trial is a phase III multi-centre randomised controlled trial whose aim is to evaluate the effectiveness and cost-effectiveness of two approaches to speech and language therapy (SLT) compared with no SLT intervention (control) for people with Parkinson's disease who have self-reported or carer-reported problems with their speech or voice. Our protocol describes the process evaluation embedded within the outcome evaluation whose aim is to evaluate what happened at the time of the PD COMM intervention implementation and to provide findings that will assist in the interpretation of the PD COMM trial results. Furthermore, the aim of the PD COMM process evaluation is to investigate intervention complexity within a theoretical model of how the trialled interventions might work best and why. Drawing from the Normalization Process Theory and frameworks for implementation fidelity, a mixed method design will be used to address process evaluation research questions. Therapists' and participants' perceptions and experiences will be investigated via in-depth interviews. Critical incident reports, baseline survey data from therapists, treatment record forms and home practice diaries also will be collected at relevant time points throughout the running of the PD COMM trial. Process evaluation data will be analysed independently of the outcome evaluation before the two sets of data are then combined. To date, there are a limited number of published process evaluation protocols, and few are linked to trials investigating rehabilitation therapies. Providing a strong theoretical framework underpinning design choices and being tailored to meet the complex characteristics of the trialled interventions, our process evaluation has the potential to provide valuable insight into which components of the interventions being delivered in PD COMM worked best (and what did not), how they worked well and why. ISRCTN Registry, ISRCTN12421382 . Registered on 18 April 2016.

Trial of Prazosin for Post-Traumatic Stress Disorder in Military Veterans.

Science.gov (United States)

Raskind, Murray A; Peskind, Elaine R; Chow, Bruce; Harris, Crystal; Davis-Karim, Anne; Holmes, Hollie A; Hart, Kimberly L; McFall, Miles; Mellman, Thomas A; Reist, Christopher; Romesser, Jennifer; Rosenheck, Robert; Shih, Mei-Chiung; Stein, Murray B; Swift, Robert; Gleason, Theresa; Lu, Ying; Huang, Grant D

2018-02-08

In randomized trials, prazosin, an α 1 -adrenoreceptor antagonist, has been effective in alleviating nightmares associated with post-traumatic stress disorder (PTSD) in military veterans. We recruited veterans from 13 Department of Veterans Affairs medical centers who had chronic PTSD and reported frequent nightmares. Participants were randomly assigned to receive prazosin or placebo for 26 weeks; the drug or placebo was administered in escalating divided doses over the course of 5 weeks to a daily maximum of 20 mg in men and 12 mg in women. After week 10, participants continued to receive prazosin or placebo in a double-blind fashion for an additional 16 weeks. The three primary outcome measures were the change in score from baseline to 10 weeks on the Clinician-Administered PTSD Scale (CAPS) item B2 ("recurrent distressing dreams"; scores range from 0 to 8, with higher scores indicating more frequent and more distressing dreams); the change in score from baseline to 10 weeks on the Pittsburgh Sleep Quality Index (PSQI; scores range from 0 to 21, with higher scores indicating worse sleep quality); and the Clinical Global Impression of Change (CGIC) score at 10 weeks (scores range from 1 to 7, with lower scores indicating greater improvement and a score of 4 indicating no change). A total of 304 participants underwent randomization; 152 were assigned to prazosin, and 152 to placebo. At 10 weeks, there were no significant differences between the prazosin group and the placebo group in the mean change from baseline in the CAPS item B2 score (between-group difference, 0.2; 95% confidence interval [CI], -0.3 to 0.8; P=0.38), in the mean change in PSQI score (between-group difference, 0.1; 95% CI, -0.9 to 1.1; P=0.80), or in the CGIC score (between-group difference, 0; 95% CI, -0.3 to 0.3; P=0.96). There were no significant differences in these measures at 26 weeks (a secondary outcome) or in other secondary outcomes. At 10 weeks, the mean difference between the

Comparison of Single Visit Post Endodontic Pain Using Mtwo Rotary and Hand K-File Instruments: A Randomized Clinical Trial

Directory of Open Access Journals (Sweden)

Mohamad Kashefinejad

2016-08-01

Full Text Available Objectives: Pain is an unpleasant outcome of endodontic treatment that can be unbearable to patients. Instrumentation techniques may affect the frequency and intensity of post-endodontic pain. This study aimed to compare single visit post endodontic pain using Mtwo (NiTi rotary and hand K-file instruments.Materials and Methods: In this randomized controlled trial, 60 teeth with symptomatic irreversible pulpitis in 53 patients were selected and randomly assigned into two groups of 30 teeth. In group A, the root canals were prepared with Mtwo (NiTi rotary instruments. In group B, the root canals were prepared with hand K-file instruments. Pain assessment was implemented using visual analog scale (VAS at four, eight, 12 and 24 hours after treatment. The acquired data were analyzed using chi-square, Mann-Whitney U and Student’s t-test (P<0.05.Results: Patients treated with rotary instruments experienced significantly less post-endodontic pain than those treated with hand instruments (P<0.001.Conclusion: The use of Mtwo (NiTi rotary instruments in root canal preparation contributed to lower incidence of postoperative pain than hand K-files.

Online Training of Discrete‐Trials Teaching for Educating Children with Autism Spectrum Disorders

DEFF Research Database (Denmark)

Zaragoza Scherman, Alejandra; Thomson, Kendra; Boris, Ashley

2015-01-01

We evaluated a self-instructional manual supported by an online Computer-Aided Personalized System of Instruction (CAPSI) for teaching Discrete-Trials Teaching (DTT) to university students. During baseline and post-training, five participants taught three tasks commonly taught to children...... with autism spectrum disor-ders to a confederate role-playing a child with autistic disorder. During training, participants studied a self-instructional manual using CAPSI to demonstrate mastery of study questions about DTT. Overall mean baseline accuracy was 54.9%, and improved to 84.7% in post...

A Randomized Trial Comparing Two Tongue-Pressure Resistance Training Protocols for Post-Stroke Dysphagia.

Science.gov (United States)

Steele, Catriona M; Bayley, Mark T; Peladeau-Pigeon, Melanie; Nagy, Ahmed; Namasivayam, Ashwini M; Stokely, Shauna L; Wolkin, Talia

2016-06-01

The objective of this study was to compare the outcomes of two tongue resistance training protocols. One protocol ("tongue-pressure profile training") emphasized the pressure-timing patterns that are typically seen in healthy swallows by focusing on gradual pressure release and saliva swallowing tasks. The second protocol ("tongue-pressure strength and accuracy training") emphasized strength and accuracy in tongue-palate pressure generation and did not include swallowing tasks. A prospective, randomized, parallel allocation trial was conducted. Of 26 participants who were screened for eligibility, 14 received up to 24 sessions of treatment. Outcome measures of posterior tongue strength, oral bolus control, penetration-aspiration and vallecular residue were made based on videofluoroscopy analysis by blinded raters. Complete data were available for 11 participants. Significant improvements were seen in tongue strength and post-swallow vallecular residue with thin liquids, regardless of treatment condition. Stage transition duration (a measure of the duration of the bolus presence in the pharynx prior to swallow initiation, which had been chosen to capture impairments in oral bolus control) showed no significant differences. Similarly, significant improvements were not seen in median scores on the penetration-aspiration scale. This trial suggests that tongue strength can be improved with resistance training for individuals with tongue weakness following stroke. We conclude that improved penetration-aspiration does not necessarily accompany improvements in tongue strength; however, tongue-pressure resistance training does appear to be effective for reducing thin liquid vallecular residue.

A randomized controlled trial of treatments for co-occurring substance use disorders and post-traumatic stress disorder.

Science.gov (United States)

McGovern, Mark P; Lambert-Harris, Chantal; Xie, Haiyi; Meier, Andrea; McLeman, Bethany; Saunders, Elizabeth

2015-07-01

Post-traumatic stress disorder (PTSD) is common among people with substance use disorders, and the comorbidity is associated with negative outcomes. We report on a randomized controlled trial comparing the effect of integrated cognitive-behavioral therapy (ICBT) plus standard care, individual addiction counseling plus standard care and standard care alone on substance use and PTSD symptoms. Three-group, multi-site randomized controlled trial. Seven addiction treatment programs in Vermont and New Hampshire, USA. Recruitment took place between December 2010 and January 2013. In this single-blind study, 221 participants were randomized to one of three conditions: ICBT plus standard care (SC) (n = 73), individual addiction counseling (IAC) plus SC (n = 75) or SC only (n = 73). One hundred and seventy-two patients were assessed at 6-month follow-up (58 ICBT; 61 IAC; 53 SC). Intervention and comparators: ICBT is a manual-guided therapy focused on PTSD and substance use symptom reduction with three main components: patient education, mindful relaxation and flexible thinking. IAC is a manual-guided therapy focused exclusively on substance use and recovery with modules organized in a stage-based approach: treatment initiation, early abstinence, maintaining abstinence and recovery. SC are intensive out-patient program services that include 9-12 hours of face-to-face contact per week over 2-4 days of group and individual therapies plus medication management. Primary outcomes were PTSD severity and substance use severity at 6 months. Secondary outcomes were therapy retention. PTSD symptoms reduced in all conditions with no difference between them. In analyses of covariance, ICBT produced more favorable outcomes on toxicology than IAC or SC [comparison with IAC, parameter estimate: 1.10; confidence interval (CI) = 0.17-2.04; comparison with SC, parameter estimate: 1.13; CI = 0.18-2.08] and had a greater reduction in reported drug use than SC (parameter estimate: -9.92; CI =�

The Sandia/Arzamas-16 Magazine-to-Magazine Remote Monitoring Field Trial Evaluation

International Nuclear Information System (INIS)

Barkanov, Boris; Blagin, Sergei; Croessmann, Dennis; Damico, Joe; Ehle, Steve; Nilsen, Curt

1999-01-01

Sandia National Laboratories and the Russian Federal Nuclear Center-All Russian Research Institute for Experimental Physics (VNIIEF) (also known as Arzamas-16) are collaborating on ways to assure the highest standards of safety, security, and international accountability of fissile material. For these collaborations, sensors and information technologies have been identified as important in reaching these standards in a cost-effective manner. Specifically, Sandia and VNIIEF have established a series of remote monitoring field trials to provide a mechanism for joint research and development on storage monitoring systems. These efforts consist of the ''Container-to-Container'', ''Magazine-to-Magazine'', and ''Facility-to-Facility'' field trials. This paper will describe the evaluation exercise Sandia and VNIIEF conducted on the Magazine-to-Magazine systems. Topics covered will include a description of the evaluation philosophy, how the various sensors and system features were tested, evaluation results, and lessons learned

REM Desensitization as a New Therapeutic Method for Post- Traumatic Stress Disorder: A Randomized Controlled Trial

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Khodabakhsh Ahmadi

2016-05-01

Full Text Available Aim: to evaluate potential efficacy of a new therapeutic approach in posttraumatic stress disorder in comparison with eye movement desensitization and reprocessing (EMDR, a standard treatment approach and controls. Methods: the study was designed using a randomized controlled trial methodology. Participants were recruited from military servicemen aged between 25 to 50 years who were admitting hospitals of Bushehr, Iran, with the final diagnosis of PTSD. Finally 33 male patients were devided into three subgroups: G1: EMDR; G2: REM Desensitization; and group 3: controls who received no therapy. Mississippi Scale for Posttraumatic Stress Disorder, Pittsburgh Sleep Quality Index (PSQI and a 37 item death anxiety questionnaire were used for measures. Results: multiple comparisons showed that intrusive thoughts were significantly more likely to improve with REM Desensitization versus EMDR (P=0.03, while depression was more responsive to EMDR (p=0.03. Among the Pittsburgh scale for the quality of sleep items, sleep quality (p=0.02, sleep duration (p=0.001, and total sleep quality score (p=0.002 were significantly more likely to improve in the REM Desensitization group. Change in the absolute death anxiety scores was not different between subgroups excepting EMDR versus control group (p=0.05. Conclusion: REM, desensitization, the new therapeutic approach to PTSD is a highly effective strategy, even more than EMDR, the standard treatment, in most of the evaluated subjects, with special emphasis on sleep symptoms, and also in the management of intrusive thoughts. Depression is the only factor in which, REM Desensitization was significantly less likely to represent a superior therapeutic effect than EMDR. Key words: post traumatic stress disorder (PTSD, eye movement desensitization and reprocessing, new treatment.

A randomised controlled trial of a cognitive behavioural intervention for men who have hot flushes following prostate cancer treatment (MANCAN: trial protocol

Directory of Open Access Journals (Sweden)

Yousaf Omar

2012-06-01

Full Text Available Abstract Background This randomised controlled trial (RCT aims to evaluate the effectiveness of a guided self-help cognitive behavioural intervention to alleviate problematic hot flushes (HF and night sweats (NS in men who are undergoing prostate cancer treatment. The trial and the self-help materials have been adapted from a previous RCT, which showed that a cognitive behavioural intervention reduced the self-reported problem-rating of hot flushes in women with menopausal symptoms, and in women undergoing breast cancer treatment. We hypothesize that guided self-help will be more effective than usual care in reducing HF/NS problem-rating at post treatment assessment. Methods/Design Seventy men who are undergoing treatment for prostate cancer and who have been experiencing more than ten HF/NS weekly for over a month are recruited into the trial from urology clinics in London. They are randomly allocated to either a four-week self-help cognitive behavioural therapy (CBT treatment or to their usual care (control group. The treatment includes information and discussion about hot flushes and night sweats in the context of prostate cancer, monitoring and modifying precipitants, relaxation and paced respiration, stress management, cognitive therapy for unhelpful thoughts and beliefs, managing sleep and night sweats, and advice on maintaining these changes. Prior to randomisation, men attend a clinical interview, undergo 24-48-hour sternal skin conductance monitoring, and complete pre-treatment questionnaires (e.g., problem-rating and frequency of hot flushes and night sweats; quality of life; mood; hot flush beliefs and behaviours. Post-treatment measures (sternal skin conductance and the above questionnaires are collected four-six weeks later, and again at a six-month follow-up. Discussion MANCAN is the first randomised controlled trial of cognitive behavioural therapy for HF/NS for men that measures both self-reported and physiologically indexed

SPIRIT trial: A phase III pragmatic trial of an advance care planning intervention in ESRD.

Science.gov (United States)

Song, Mi-Kyung; Unruh, Mark L; Manatunga, Amita; Plantinga, Laura C; Lea, Janice; Jhamb, Manisha; Kshirsagar, Abhijit V; Ward, Sandra E

2018-01-01

Advance care planning (ACP) is a central tenet of dialysis care, but the vast majority of dialysis patients report never engaging in ACP discussions with their care providers. Over the last decade, we have developed and iteratively tested SPIRIT (Sharing Patient's Illness Representation to Increase Trust), a theory-based, patient- and family-centered advance care planning intervention. SPIRIT is a six-step, two-session, face-to-face intervention to promote cognitive and emotional preparation for end-of-life decision making for patients with ESRD and their surrogates. In these explanatory trials, SPIRIT was delivered by trained research nurses. Findings consistently revealed that patients and surrogates in SPIRIT showed significant improvement in preparedness for end-of-life decision making, and surrogates in SPIRIT reported significantly improved post-bereavement psychological outcomes after the patient's death compared to a no treatment comparison condition. As a critical next step, we are conducting an effectiveness-implementation study. This study is a multicenter, clinic-level cluster randomized pragmatic trial to evaluate the effectiveness of SPIRIT delivered by dialysis care providers as part of routine care in free-standing outpatient dialysis clinics, compared to usual care plus delayed SPIRIT implementation. Simultaneously, we will evaluate the implementation of SPIRIT, including sustainability. We will recruit 400 dyads of patients at high risk of death in the next year and their surrogates from 30 dialysis clinics in four states. This trial of SPIRIT will generate novel, meaningful insights about improving ACP in dialysis care. ClinicalTrials.govNCT03138564, registered 05/01/2017. Copyright © 2017 Elsevier Inc. All rights reserved.

The effect of intravenous dextrose administration for prevention of post-operative nausea and vomiting after laparoscopic cholecystectomy: A double-blind, randomised controlled trial.

Science.gov (United States)

Firouzian, Abolfazl; Kiasari, Alieh Zamani; Godazandeh, Gholamali; Baradari, Afshin Gholipour; Alipour, Abbas; Taheri, Arman; Emami Zeydi, Amir; Montazemi, Maryam

2017-10-01

Post-operative nausea and vomiting (PONV) is a common and distressing complication after laparoscopic cholecystectomy (LC). The aim of this study was to evaluate the effect of intravenous (IV) dextrose administration for the prophylaxis of PONV after LC. In a double-blind, randomised controlled trial, a total of 150 female patients who were scheduled for elective LC were randomly assigned into two groups (A and B). Thirty minutes before induction of anaesthesia, patients received an infusion of 500 cc lactated Ringer's solution (Group A) and 5% dextrose in lactated Ringer's solution (Group B) and over a period of 30 min. All patients rated their nausea and vomiting intensity using the verbal rating scale immediately at post-anaesthesia care unit (PACU) arrival; 30, 60, 90 and 120 min after arriving at the PACU and 6, 12 and 24 h after surgery. There was a statistically significant time trend and group effect along with significant differences in time/group interaction effect in both groups for nausea and vomiting scores ( P Dextrose administration reduced the odds of vomiting events compared to placebo (estimate: -0.87, odds ratio = 0.42, 95% confidence interval: 0.28-0.64). Administration of IV dextrose before anaesthesia induction may be recommended as an effective, and safe method for the prophylaxis of PONV after LC.

Evaluating and Reporting Dysphagia in Trials of Chemoirradiation for Head-and-Neck Cancer

International Nuclear Information System (INIS)

Gluck, Iris; Feng, Felix Y.; Lyden, Teresa; Haxer, Marc

2010-01-01

Purpose: Reporting long-term toxicities in trials of chemoirradiation (CRT) of head-and-neck cancer (HNC) has mostly been limited to observer-rated maximal Grades ≥3. We evaluated this reporting approach for dysphagia by assessing patient-reported dysphagia (PRD) and objective swallowing dysfunction through videofluoroscopy (VF) in patients with various grades of maximal observer-reported dysphagia (ORD). Methods and Materials: A total of 62 HNC patients completed quality-of-life questionnaires periodically through 12 months post-CRT. Five PRD items were selected: three dysphagia-specific questions, an Eating-Domain, and 'Overall Bother.' They underwent VF at 3 and 12 months, and ORD (Common Terminology Criteria for Adverse Events) scoring every 2 months. We classified patients into four groups (0-3) according to maximal ORD scores documented 3-12 months post-CRT, and assessed PRD and VF summary scores in each group. Results: Differences in ORD scores among the groups were considerable throughout the observation period. In contrast, PRD scores were similar between Groups 2 and 3, and variable in Group 1. VF scores were worse in Group 3 compared with 2 at 3 months but similar at 12 months. In Group 1, PRD and VF scores from 3 through 12 months were close to Groups 2 and 3 if ORD score 1 persisted, but were similar to Group 0 in patients whose ORD scores improved by 12 months. Conclusions: Patients with lower maximal ORD grades, especially if persistent, had similar rates of PRD and objective dysphagia as patients with highest grades. Lower ORD grades should therefore be reported. These findings may have implications for reporting additional toxicities besides dysphagia.

Does the effect of one-day simulation team training in obstetric emergencies decline within one year? A post-hoc analysis of a multicentre cluster randomised controlled trial.

Science.gov (United States)

van de Ven, J; Fransen, A F; Schuit, E; van Runnard Heimel, P J; Mol, B W; Oei, S G

2017-09-01

Does the effect of one-day simulation team training in obstetric emergencies decline within one year? A post-hoc analysis of a multicentre cluster randomised controlled trial. J van de Ven, AF Fransen, E Schuit, PJ van Runnard Heimel, BW Mol, SG Oei OBJECTIVE: To investigate whether the effect of a one-day simulation-based obstetric team training on patient outcome changes over time. Post-hoc analysis of a multicentre, open, randomised controlled trial that evaluated team training in obstetrics (TOSTI study).We studied women with a singleton pregnancy beyond 24 weeks of gestation in 24 obstetric units. Included obstetric units were randomised to either a one-day, multi-professional simulation-based team training focusing on crew resource management in a medical simulation centre (12 units) or to no team training (12 units). We assessed whether outcomes differed between both groups in each of the first four quarters following the team training and compared the effect of team training over quarters. Primary outcome was a composite outcome of low Apgar score, severe postpartum haemorrhage, trauma due to shoulder dystocia, eclampsia and hypoxic-ischemic encephalopathy. During a one year period after the team training the rate of obstetric complications, both on the composite level and the individual component level, did not differ between any of the quarters. For trauma due to shoulder dystocia team training led to a significant decrease in the first quarter (0.06% versus 0.26%, OR 0.19, 95% CI 0.03 to 0.98) but in the subsequent quarters no significant reductions were observed. Similar results were found for invasive treatment for severe postpartum haemorrhage where a significant increase was only seen in the first quarter (0.4% versus 0.03%, OR 19, 95% CI 2.5-147), and not thereafter. The beneficial effect of a one-day, simulation-based, multiprofessional, obstetric team training seems to decline after three months. If team training is further evaluated or

(Costeffectiveness of life review for Older Adults: Design of a randomized controlled trial

Directory of Open Access Journals (Sweden)

Onrust Simone

2008-06-01

Full Text Available Abstract Background Depression in older adults is a serious health problem with a poor prognosis. There is a need for indicated preventive psychological interventions for older adults, that show to be promising in preventing depressive disorders. Methods/design This manuscript describes the design of a study evaluating 'Looking for Meaning', a newly developed prevention course for older adults with depressive symptoms, based on life-review. Both clinical and economic effectiveness are evaluated in a pragmatic randomized controlled trial. The control condition of this 12-session preventive intervention is a 20-minute video movie. The primary outcome is symptoms of depression at post-treatment and follow-up (6 months after post-treatment. Secondary outcomes are symptoms of anxiety, satisfaction with life, mastery, reminiscence styles, quality of life, and health care costs. An additional result of this study is the insight into the working elements of the course, provided by the qualitative study. The qualitative data, mainly based on 20 open-ended interviews with participants, are to be analyzed with an emphasis on newly emerging insight. Discussion This study will add to the existing scientific knowledge in several ways, especially by also including an economic evaluation and a qualitative study to gain insight into the working mechanisms of the course, both rather new in the field of life review. Positive results of this study will make an evidence-based intervention to improve public health among older people available. Trial registration Current Controlled Trials Ltd, ISRCTN66645855

[Response of Pharmaceutical Companies to the Crisis of Post-Marketing Clinical Trials of Anti-Cancer Agents -- Results of Questionnaires to Pharmaceutical Companies].

Science.gov (United States)

Nakajima, Toshifusa

2016-04-01

Investigator-oriented post-marketing clinical trials of anti-cancer agents are faced to financial crisis due to drastic decrease in research-funds from pharmaceutical companies caused by a scandal in 2013. In order to assess the balance of research funds between 2012 and 2014, we made queries to 26 companies manufacturing anti-cancer agents, and only 10 of 26 responded to our queries. Decrease in the fund was observed in 5 of 10, no change in 1, increase in 3 and no answer in 1. Companies showed passive attitude to carry out doctor-oriented clinical trials of off-patent drugs or unapproved drugs according to advanced medical care B program, though some companies answered to proceed approved routines of these drugs if clinical trials showed good results. Most companies declined to make comments on the activity of Japan Agency for Medical Research and Development (AMED), but some insisted to produce good corroboration between AMED and pharmaceutical companies in order to improve the quality of trials. Further corroboration must be necessary for this purpose among researchers, governmental administrative organs, pharmaceutical companies, patients' groups, and mass-media.

An open-label Optional Titration Trial to Evaluate the Efficacy ...

African Journals Online (AJOL)

An eight-week open-label optional titration trial to evaluate the efficacy, tolerability and safety of Valsartan 80 mg/ & 160 mg once daily was carried out in patients with mild to moderate essential hypertension at the Lagos University Teaching Hospital. There was a significant reduction in both systolic and diastolic blood ...

[Methodological quality evaluation of randomized controlled trials for traditional Chinese medicines for treatment of sub-health].

Science.gov (United States)

Zhao, Jun; Liao, Xing; Zhao, Hui; Li, Zhi-Geng; Wang, Nan-Yue; Wang, Li-Min

2016-11-01

To evaluate the methodological quality of the randomized controlled trials(RCTs) for traditional Chinese medicines for treatment of sub-health, in order to provide a scientific basis for the improvement of clinical trials and systematic review. Such databases as CNKI, CBM, VIP, Wanfang, EMbase, Medline, Clinical Trials, Web of Science and Cochrane Library were searched for RCTS for traditional Chinese medicines for treatment of sub-health between the time of establishment and February 29, 2016. Cochrane Handbook 5.1 was used to screen literatures and extract data, and CONSORT statement and CONSORT for traditional Chinese medicine statement were adopted as the basis for quality evaluation. Among the 72 RCTs included in this study, 67 (93.05%) trials described the inter-group baseline data comparability, 39(54.17%) trials described the unified diagnostic criteria, 28(38.89%) trials described the unified standards of efficacy, 4 (5.55%) trials mentioned the multi-center study, 19(26.38%) trials disclosed the random distribution method, 6(8.33%) trials used the random distribution concealment, 15(20.83%) trials adopted the method of blindness, 3(4.17%) study reported the sample size estimation in details, 5 (6.94%) trials showed a sample size of more than two hundred, 19(26.38%) trials reported the number of withdrawal, defluxion cases and those lost to follow-up, but only 2 trials adopted the ITT analysis,10(13.89%) trials reported the follow-up results, none of the trial reported the test registration and the test protocol, 48(66.7%) trials reported all of the indicators of expected outcomes, 26(36.11%) trials reported the adverse reactions and adverse events, and 4(5.56%) trials reported patient compliance. The overall quality of these randomized controlled trials for traditional Chinese medicines for treatment of sub-health is low, with methodological defects in different degrees. Therefore, it is still necessary to emphasize the correct application of principles

Tailored internet-administered treatment of anxiety disorders for primary care patients: study protocol for a randomised controlled trial

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Nordgren Lise

2012-02-01

Full Text Available Abstract Background Internet-administered cognitive behavioural therapy (ICBT has been found to be effective for a range of anxiety disorders. However, most studies have focused on one specific primary diagnosis and co-morbidity has not been considered. In primary care settings, patients with anxiety often suffer from more than one psychiatric condition, making it difficult to disseminate ICBT for specific conditions. The aim of this study will be to investigate if ICBT tailored according to symptom profile can be a feasible treatment for primary care patients with anxiety disorders. It is a randomised controlled trial aimed to evaluate the treatment against an active control group. Methods Participants with anxiety disorders and co-morbid conditions (N = 128, will be recruited from a primary care population. The Clinical Outcome in Routine Evaluation (CORE-OM will serve as the primary outcome measure. Secondary measures include self-reported depression, anxiety, quality of life and loss of production and the use of health care. All assessments will be collected via the Internet and measure points will be baseline, post treatment and 12 months post treatment. Discussion This trial will add to the body of knowledge on the effectiveness of ICBT for anxiety disorders in primary care. The trial will also add knowledge on the long term effects of ICBT when delivered for regular clinic patients Trial Registration ClinicalTrials.gov: NCT01390168

ESCAPS study protocol: a feasibility randomised controlled trial of 'Early electrical stimulation to the wrist extensors and wrist flexors to prevent the post-stroke complications of pain and contractures in the paretic arm'.

Science.gov (United States)

Fletcher-Smith, Joanna C; Walker, Dawn-Marie; Sprigg, Nikola; James, Marilyn; Walker, Marion F; Allatt, Kate; Mehta, Rajnikant; Pandyan, Anand D

2016-01-04

Approximately 70% of patients with stroke experience impaired arm function, which is persistent and disabling for an estimated 40%. Loss of function reduces independence in daily activities and impacts on quality of life. Muscles in those who do not recover functional movement in the stroke affected arm are at risk of atrophy and contractures, which can be established as early as 6 weeks following stroke. Pain is also common. This study aims to evaluate the feasibility of a randomised controlled trial to test the efficacy and cost-effectiveness of delivering early intensive electrical stimulation (ES) to prevent post-stroke complications in the paretic upper limb. This is a feasibility randomised controlled trial (n=40) with embedded qualitative studies (patient/carer interviews and therapist focus groups) and feasibility economic evaluation. Patients will be recruited from the Stroke Unit at the Nottingham University Hospitals National Health Service (NHS) Trust within 72 h after stroke. Participants will be randomised to receive usual care or usual care and early ES to the wrist flexors and extensors for 30 min twice a day, 5 days a week for 3 months. The initial treatment(s) will be delivered by an occupational therapist or physiotherapist who will then train the patient and/or their nominated carer to self-manage subsequent treatments. This study has been granted ethical approval by the National Research Ethics Service, East Midlands Nottingham1 Research Ethics Committee (ref: 15/EM/0006). To our knowledge, this is the first study of its kind of the early application (within 72 h post-stroke) of ES to both the wrist extensors and wrist flexors of stroke survivors with upper limb impairment. The results will inform the design of a definitive randomised controlled trial. Dissemination will include 2 peer-reviewed journal publications and presentations at national conferences. ISRCTN1648908; Pre-results. Clinicaltrials.gov ID: NCT02324634. Published by the BMJ

Protocol for the effect evaluation of independent medical evaluation after six months sick leave: a randomized controlled trial of independent medical evaluation versus treatment as usual in Norway

Directory of Open Access Journals (Sweden)

Elisabeth Husabo

2017-06-01

Full Text Available Abstract Background It has been discussed whether the relationship between a patient on sick leave and his/her general practitioner (GP is too close, as this may hinder the GP’s objective evaluation of need for sick leave. Independent medical evaluation involves an independent physician consulting the patient. This could lead to new perspectives on sick leave and how to follow-up the patient. Methods/design The current study is a randomized controlled trial in a Norwegian primary care context, involving an effect evaluation, a cost/benefit analysis, and a qualitative evaluation. Independent medical evaluation will be compared to treatment as usual, i.e., the physicians’ and social insurance agencies’ current management of long-term sick-listed patients. Individuals aged 18–65 years, sick listed by their GP and on full or partial sick leave for the past 6 months in Hordaland county will be included. Exclusion criteria are pregnancy, cancer, dementia or an ICD-10 diagnosis. A total sample of 3800 will be randomly assigned to either independent medical evaluation or treatment as usual. Official register data will be used to measure the primary outcome; change in sickness benefits at 7, 9 and 12 months. Sick listed in other counties will serve as a second control group, if appropriate under the “common trend” assumption. Discussion The Norwegian effect evaluation of independent medical evaluation after 6 months sick leave is a large randomized controlled trial, and the first of its kind, to evaluate this type of intervention as a means of getting people back to work after long-term sickness absence. Trial registration ClinicalTrials.gov NCT02524392 . Registered June 23, 2015.

The post-activation potentiation effect on sprint performance after combined resistance/sprint training in junior basketball players.

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Tsimachidis, Constantinos; Patikas, Dimitrios; Galazoulas, Christos; Bassa, Eleni; Kotzamanidis, Christos

2013-01-01

The aim of this study was to examine the effect of a 10-week combined resistance/sprint training programme in the post-activation potentiation of sprint performance before, between and after resistance training sets. Twenty-six junior basketball players were randomly divided into a control and a combined training group. The combined training group performed a combined training programme consisting of 5 sets at 5-8 RM (Repetition Maximum) half-squats with sprints performed between each set. Post-activation potentiation was considered as the increase in sprint velocity in trials executed between and after the resistance sets compared with the sprint trial performed before the resistance sets of the respective first and last training session. For sprint evaluation the running distances 0-10 and 0-30 m were selected. The intervention increased both strength and sprint performance. No post-activation potentiation effect was observed during the first training session in either group. Post-activation potentiation appeared in the combined training group during the last training session of the intervention in both 0-10 and 0-30 m sprint. This study illustrates that post-activation potentiation effect on sprint performance in junior basketball players, who did not previously follow systematic resistance training, emerges after a 10-week resistance/sprint combined training programme.

Evaluation of early efficacy endpoints for proof-of-concept trials.

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Chen, Cong; Sun, Linda; Li, Chih-Lin

2013-03-11

A Phase II proof-of-concept (POC) trial usually uses an early efficacy endpoint other than a clinical endpoint as the primary endpoint. Because of the advancement in bioscience and technology, which has yielded a number of new surrogate biomarkers, drug developers often have more candidate endpoints to choose from than they can handle. As a result, selection of endpoint and its effect size as well as choice of type I/II error rates are often at the center of heated debates in design of POC trials. While optimization of the trade-off between benefit and cost is the implicit objective in such a decision-making process, it is seldom explicitly accounted for in practice. In this research note, motivated by real examples from the oncology field, we provide practical measures for evaluation of early efficacy endpoints (E4) for POC trials. We further provide optimal design strategies for POC trials that include optimal Go-No Go decision criteria for initiation of Phase III and optimal resource allocation strategies for conducting multiple POC trials in a portfolio under fixed resources. Although oncology is used for illustration purpose, the same idea developed in this research note also applies to similar situations in other therapeutic areas or in early-stage drug development in that a Go-No Go decision has to rely on limited data from an early efficacy endpoint and cost-effectiveness is the main concern.

Evaluating FDG uptake changes between pre and post therapy respiratory gated PET scans

International Nuclear Information System (INIS)

Aristophanous, Michalis; Yong, Yue; Yap, Jeffrey T.; Killoran, Joseph H.; Allen, Aaron M.; Berbeco, Ross I.; Chen, Aileen B.

2012-01-01

Purpose: Whole body (3D) and respiratory gated (4D) FDG-PET/CT scans performed pre-radiotherapy (pre-RT) and post-radiotherapy (post-RT) were analyzed to investigate the impact of 4D PET in evaluating 18F-fluorodeoxyglucose (FDG) uptake changes due to therapy, relative to traditional 3D PET. Methods and materials: 3D and 4D sequential FDG-PET/CT scans were acquired pre-RT and approximately one month post-RT for patients with non-small cell lung cancer (NSCLC). The lesions of high uptake targeted with radiotherapy were identified on the pre-RT scan of each patient. Each lesion on the 3D and each of the five phases of the 4D scan were analyzed using a region of interest (ROI). For each patient the ROIs of the pre-RT scans were used to locate the areas of initial FDG uptake on the post-RT scans following rigid registration. Post-RT ROIs were drawn and the FDG uptake was compared with that of the pre-RT scans. Results: Sixteen distinct lesions from 12 patients were identified and analyzed. Standardized uptake value (SUV) maxima were significantly higher (p-value <0.005) for the lesions as measured on the 4D compared to 3D PET. Comparison of serial pre and post-RT scans showed a mean 62% decrease in SUV with the 3D PET scan (range 36–89%), and a 67% decrease with the 4D PET scan (range 30–89%). The mean absolute difference in SUV change on 3D versus 4D scans was 4.9%, with a range 0–15% (p-value = 0.07). Conclusions: Signal recovery with 4D PET results in higher SUVs when compared to standard 3D PET. Consequently, differences in the evaluation of SUV changes between pre and post-RT plans were observed. Such difference can have a significant impact in PET-based response assessment.

Trauma-focused cognitive behaviour therapy versus treatment as usual for post traumatic stress disorder (PTSD) in young children aged 3 to 8 years: study protocol for a randomised controlled trial.

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Dalgleish, Tim; Goodall, Benjamin; Chadwick, Isobel; Werner-Seidler, Aliza; McKinnon, Anna; Morant, Nicola; Schweizer, Susanne; Panesar, Inderpal; Humphrey, Ayla; Watson, Peter; Lafortune, Louise; Smith, Patrick; Meiser-Stedman, Richard

2015-03-25

Following horrific or life-threatening events approximately 10 to 15% of young children develop post traumatic stress disorder (PTSD). The symptoms of this disorder are distressing - nightmares, flashbacks, anger outbursts and disturbed play. These symptoms cause major disruption to a child's functioning and, if left untreated, can persist for many years. As yet, there are no established empirically-validated treatments for PTSD in young children. Trauma-focused cognitive behaviour therapy (TF-CBT) is a psychological intervention that is effective in treating the disorder in older children (8 to 12 years), adolescents and adults. This study examines TF-CBT adapted for children aged between 3 and 8 years. This protocol describes a two-arm exploratory randomised controlled trial comparing TF-CBT to treatment as usual (TAU) in children aged 3 to 8 years with a principal diagnosis of PTSD following a single-event discrete trauma. Using a half-crossover design, 44 participants will be randomly allocated to receive the intervention or to receive TAU. Those allocated to TAU will be offered TF-CBT at the end of the 'treatment' period (approximately 12 weeks) if still indicated. The primary outcome is PTSD diagnosis according to DSM-5 criteria for children 6 years and younger at post-treatment. Secondary outcomes include effects on co-morbid diagnoses and changes in emotion and trauma symptoms at each of the follow-up points (post-treatment, 3-months, 12-months). Additionally, broader efficacy will be considered with regard to treatment feasibility, acceptability and service utilisation. The key targets of the intervention are trauma memory, the interpretation of the meaning of the event, and the management of symptoms. This is the first European trial to examine the efficacy of TF-CBT in alleviating PTSD in very young children. As well as providing much-needed data on the utility of the intervention, this exploratory trial will also allow us to gather important information

Evaluating the PRASE patient safety intervention - a multi-centre, cluster trial with a qualitative process evaluation: study protocol for a randomised controlled trial.

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Sheard, Laura; O'Hara, Jane; Armitage, Gerry; Wright, John; Cocks, Kim; McEachan, Rosemary; Watt, Ian; Lawton, Rebecca

2014-10-29

Estimates show that as many as one in 10 patients are harmed while receiving hospital care. Previous strategies to improve safety have focused on developing incident reporting systems and changing systems of care and professional behaviour, with little involvement of patients. The need to engage with patients about the quality and safety of their care has never been more evident with recent high profile reviews of poor hospital care all emphasising the need to develop and support better systems for capturing and responding to the patient perspective on their care. Over the past 3 years, our research team have developed, tested and refined the PRASE (Patient Reporting and Action for a Safe Environment) intervention, which gains patient feedback about quality and safety on hospital wards. A multi-centre, cluster, wait list design, randomised controlled trial with an embedded qualitative process evaluation. The aim is to assess the efficacy of the PRASE intervention, in achieving patient safety improvements over a 12-month period.The trial will take place across 32 hospital wards in three NHS Hospital Trusts in the North of England. The PRASE intervention comprises two tools: (1) a 44-item questionnaire which asks patients about safety concerns and issues; and (2) a proforma for patients to report (a) any specific patient safety incidents they have been involved in or witnessed and (b) any positive experiences. These two tools then provide data which are fed back to wards in a structured feedback report. Using this report, ward staff are asked to hold action planning meetings (APMs) in order to action plan, then implement their plans in line with the issues raised by patients in order to improve patient safety and the patient experience.The trial will be subjected to a rigorous qualitative process evaluation which will enable interpretation of the trial results. fieldworker diaries, ethnographic observation of APMs, structured interviews with APM lead and collection

Using the TED Talks to Evaluate Spoken Post-editing of Machine Translation

DEFF Research Database (Denmark)

Liyanapathirana, Jeevanthi; Popescu-Belis, Andrei

2016-01-01

This paper presents a solution to evaluate spoken post-editing of imperfect machine translation output by a human translator. We compare two approaches to the combination of machine translation (MT) and automatic speech recognition (ASR): a heuristic algorithm and a machine learning method...

Using digital multimedia to improve parents' and children's understanding of clinical trials.

Science.gov (United States)

Tait, Alan R; Voepel-Lewis, Terri; Levine, Robert

2015-06-01

Data show that many research subjects have difficulty understanding study information using traditional paper consent documents. This study, therefore, was designed to evaluate the effect of an interactive multimedia program on improving parents' and children's understanding of clinical trial concepts and participation. Parents (n=148) and children (n=135) were each randomised to receive information regarding clinical trials using either a traditional paper format (TF) or an interactive iPad program (IP) with inline exercises. Participants' understanding of the information was assessed using semistructured interviews prior to (pretest) and after (post-test) receiving the information. Participants also completed a short survey to assess their perceptions of information delivery and satisfaction with the process. Regardless of the mode of information delivery, all participants demonstrated improved pretest to post-test understanding. While there were no statistical differences in parents' post-test understanding between the TF and IP groups, children in the IP group had significantly greater post-test understanding compared with children in the TF group (11.65 (4.1) vs 8.85 (4.1) (2.8, 1.4, 4.2) 0-18 scale where 18=complete understanding). Furthermore, the IP was found to be significantly 'easier to follow' and 'more effective' in presenting information compared with the TF. Results demonstrated the importance of providing information regarding clinical trial concepts to parents and children. Importantly, the ability of interactive multimedia to improve understanding of clinical trial concepts and satisfaction with information delivery, particularly among children, supports this approach as a novel and effective vehicle for enhancing the informed consent process. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

ISP 22 OECD/NEA/CSNI International standard problem n. 22. Evaluation of post-test analyses

International Nuclear Information System (INIS)

1992-07-01

The present report deals with the open re-evaluation of the originally double-blind CSNI International Standard Problem 22 based on the test SP-FW-02 performed in the SPES facility. The SPES apparatus is an experimental simulator of the Westinghouse PWR-PUN plant. The test SP-FW-02 (ISP22) simulates a complete loss of feedwater with delayed injection of auxiliary feedwater. The main parts of the report are: outline of the test facility and of the SP-FW-02 experiment; overview of pre-test activities; overview of input models used by post-test participants; evaluation of participant predictions; evaluation of qualitative and quantitative code accuracy of pre-test and post-test calculations

Group Cognitive-Behavior Therapy and Supportive Art and Sport Interventions on Bam Earthquake Related Post Traumatic Stress Symptoms in Children: A Field Trial

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Narges Joshaghani

2009-12-01

Full Text Available "n Objective: "n "nThe main objective of this study is to evaluate the effect of psychological therapies and art/sport supportive interventions separately,and in combination on post traumatic stress symptoms in children and compare them with a control group . "nMethods: In a field trial, we evaluated the efficacy of group behavioral therapy, art and sport supportive interventions in Bam earthquake children survivors with PTSD symptoms and compared it with a control group. Before and after interventions we evaluated the PTSD symptoms using K-SADS-PL semi-structural interview for each group and compared them using appropriate statistical methods. "nResults: The participants were 200 individuals who were randomized in four groups according to an intervention program including: Group behavioral therapy; Group behavioral therapy plus art and sport interventions; Art and sport interventions; and control group. During the interventions, 39 individuals were excluded. None of the participants had severed PTSD or other psychiatry disorders that needed pharmacological interventions. In interventional groups, the reduction of total PTSD symptoms and the symptoms of re-experience, avoidance and hyper arousal was not statistically significant. However, in the control group, the PTSD symptoms increased during the study which was statistically significant. "nConclusion: Group behavior therapy and supportive interventions (art and sport may have preventive effects on PTSD symptoms.

Economic evaluation of a bio-psycho-social intervention for comorbid disorders in a traumatized population in post-war Kosovo.

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Chang, Wei-Lun; Andersen, Carit Jacques; Berisha, Besa Shatri; Estrup, Olena; Wang, Shr-Jie

2018-05-08

Post-hoc economic evaluation of a bio-psycho-social intervention in post-war Kosovo from a societal perspective. Cost-effectiveness analysis, cost-utility analysis, and partial cost-benefit analysis using data from a randomized controlled trial. Thirty-four torture/war victims with comorbid conditions enrolled in 2012-2013. Participants were randomly assigned to an "intervention" and a "waiting-list" group. Changes in mental, emotional and physical health and functional impairment were assessed before and after treatment, along with increase in labour income as a proxy for productivity gain. The cost of an extra unit of effectiveness and an additional quality-adjusted life year were calculated. The total cost per participant was €1,322 including, or €1,019 excluding, research costs. Wide variations in costs of changes in mental, emotional and physical effectiveness were demonstrated. Multidisciplinary intervention resulted in functional improvement at a cost of €10,508 per quality-adjusted life year gained. With a mean monthly income increase to €133 (18%) after intervention, the intervention cost per participant would be equal to the total increase in monthly income after 4-5 years, assuming the increased level is maintained. Socio-economic benefit associated with quality-adjusted life year gain is shown, although the cost of an additional quality-adjusted life year is above the World Health Organization cost-effectiveness threshold.

Chelation therapy after the Trial to Assess Chelation Therapy: results of a unique trial

Science.gov (United States)

Avila, Maria D.; Escolar, Esteban; Lamas, Gervasio A.

2014-01-01

Purpose of review EDTA chelation therapy has been in off-label use for the treatment of atherosclerosis. We review the results of the first large-scale randomized trial of this treatment. Recent findings The trial to assess chelation therapy was a $30 million National Institutes of Health-funded study of the safety and efficacy of EDTA-based chelation infusions in 1708 post-myocardial infarction (MI) patients. The trial to assess chelation therapy demonstrated a significant (P = 0.035) 18% reduction in a combined primary endpoint of death, MI, stroke, coronary revascularization, or hospitalization for angina. In diabetic patients the benefit was more extreme, with a 41% relative reduction in risk (P = 0.0002) and a 43% reduction in total mortality (P = 0.011). Safety data were favorable. A reduction of oxidative stress by chelation of toxic metals has been proposed as a possible mechanism of action. Summary Recent research suggests that EDTA chelation may be a well-tolerated and effective treatment for post-MI patients. Future replication and mechanistic studies are important prior to implementation in all post-MI patients. PMID:25023079

The application of post yield fracture methodology to the evaluation of large structures

International Nuclear Information System (INIS)

Landes, J.D.

1979-01-01

The objective of this work is to determine how to use small specimens test results to measure fracture toughness values for application to the evaluation of large structural components. Linear elastic fracture mechanics concepts based on the crack tip stress intensity factor, K, have been extended into the post yield regime by the use of elastic-plastic characterizing parameters such as J integral and COD. One of the primary applications of this technology is the determination of fracture toughness values from small specimens tests taken primarily in the post yield regime which can be used to evaluate structures operating in an essentially linear elastic regime. The fracture toughness values may be either conservative or unconservative depending on the fracture mode; extreme care must be taken in interpretting these results. (orig.)

What work has to be done to implement collaborative care for depression? Process evaluation of a trial utilizing the Normalization Process Model

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Lankshear Annette J

2010-02-01

Full Text Available Abstract Background There is a considerable evidence base for 'collaborative care' as a method to improve quality of care for depression, but an acknowledged gap between efficacy and implementation. This study utilises the Normalisation Process Model (NPM to inform the process of implementation of collaborative care in both a future full-scale trial, and the wider health economy. Methods Application of the NPM to qualitative data collected in both focus groups and one-to-one interviews before and after an exploratory randomised controlled trial of a collaborative model of care for depression. Results Findings are presented as they relate to the four factors of the NPM (interactional workability, relational integration, skill-set workability, and contextual integration and a number of necessary tasks are identified. Using the model, it was possible to observe that predictions about necessary work to implement collaborative care that could be made from analysis of the pre-trial data relating to the four different factors of the NPM were indeed borne out in the post-trial data. However, additional insights were gained from the post-trial interview participants who, unlike those interviewed before the trial, had direct experience of a novel intervention. The professional freedom enjoyed by more senior mental health workers may work both for and against normalisation of collaborative care as those who wish to adopt new ways of working have the freedom to change their practice but are not obliged to do so. Conclusions The NPM provides a useful structure for both guiding and analysing the process by which an intervention is optimized for testing in a larger scale trial or for subsequent full-scale implementation.

What work has to be done to implement collaborative care for depression? Process evaluation of a trial utilizing the Normalization Process Model.

Science.gov (United States)

Gask, Linda; Bower, Peter; Lovell, Karina; Escott, Diane; Archer, Janine; Gilbody, Simon; Lankshear, Annette J; Simpson, Angela E; Richards, David A

2010-02-10

There is a considerable evidence base for 'collaborative care' as a method to improve quality of care for depression, but an acknowledged gap between efficacy and implementation. This study utilises the Normalisation Process Model (NPM) to inform the process of implementation of collaborative care in both a future full-scale trial, and the wider health economy. Application of the NPM to qualitative data collected in both focus groups and one-to-one interviews before and after an exploratory randomised controlled trial of a collaborative model of care for depression. Findings are presented as they relate to the four factors of the NPM (interactional workability, relational integration, skill-set workability, and contextual integration) and a number of necessary tasks are identified. Using the model, it was possible to observe that predictions about necessary work to implement collaborative care that could be made from analysis of the pre-trial data relating to the four different factors of the NPM were indeed borne out in the post-trial data. However, additional insights were gained from the post-trial interview participants who, unlike those interviewed before the trial, had direct experience of a novel intervention. The professional freedom enjoyed by more senior mental health workers may work both for and against normalisation of collaborative care as those who wish to adopt new ways of working have the freedom to change their practice but are not obliged to do so. The NPM provides a useful structure for both guiding and analysing the process by which an intervention is optimized for testing in a larger scale trial or for subsequent full-scale implementation.

A protocol for a pragmatic randomized controlled trial evaluating outcomes of emergency nurse practitioner service.

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Jennings, Natasha; Gardner, Glenn; O'Reilly, Gerard

2014-09-01

To evaluate emergency nurse practitioner service effectiveness on outcomes related to quality of care and service responsiveness. Increasing service pressures in the emergency setting have resulted in the adoption of service innovation models; the most common and rapidly expanding of these is the emergency nurse practitioner. The delivery of high quality patient care in the emergency department is one of the most important service indicators to be measured in health services today. The rapid uptake of emergency nurse practitioner service in Australia has outpaced the capacity to evaluate this model in outcomes related to safety and quality of patient care. Pragmatic randomized controlled trial at one site with 260 participants. This protocol describes a definitive prospective randomized controlled trial, which will examine the impact of emergency nurse practitioner service on key patient care and service indicators. The study control will be standard emergency department care. The intervention will be emergency nurse practitioner service. The primary outcome measure is pain score reduction and time to analgesia. Secondary outcome measures are waiting time, number of patients who did not wait, length of stay in the emergency department and representations within 48 hours. Scant research enquiry evaluating emergency nurse practitioner service on patient effectiveness and service responsiveness exists currently. This study is a unique trial that will test the effectiveness of the emergency nurse practitioner service on patients who present to the emergency department with pain. The research will provide an opportunity to further evaluate emergency nurse practitioner models of care and build research capacity into the workforce. Trial registration details: Australian and New Zealand Clinical Trials Registry dated 18th August 2013, ACTRN12613000933752. © 2014 John Wiley & Sons Ltd.

A parent-based intervention to promote healthy eating and active behaviours in pre-school children: evaluation of the MEND 2-4 randomized controlled trial.

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Skouteris, H; Hill, B; McCabe, M; Swinburn, B; Busija, L

2016-02-01

There is a paucity of studies evaluating targeted obesity prevention interventions in pre-school children. We conducted a randomized controlled trial to evaluate the efficacy of a parent-based obesity prevention intervention for pre-schoolers - MEND (Mind, Exercise, Nutrition … Do It!) 2-4 on child diet, eating habits, physical activity/sedentary behaviours, and body mass index (BMI). Parent-child dyads attended 10 weekly 90-min workshops relating to nutrition, physical activity and behaviours, including guided active play and healthy snack time. Assessments were conducted at baseline, immediately post-intervention, and 6 and 12 months post-intervention; child intake of vegetables, fruit, beverages, processed snack foods, fussiness, satiety responsiveness, physical activity, sedentary behaviour and neophobia were assessed via parent proxy report. Parent and child height and weight were measured. Two hundred one parent-child dyads were randomized to intervention (n = 104) and control (n = 97). Baseline mean child age was 2.7 (standard deviation [SD] 0.6) years, and child BMI-for-age z-score (World Health Organization) was 0.66 (SD 0.88). We found significant positive group effects for vegetable (P = 0.01) and snack food (P = 0.03) intake, and satiety responsiveness (P = 0.047) immediately post-intervention. At 12 months follow-up, intervention children exhibited less neophobia (P = 0.03) than controls. Future research should focus on additional strategies to support parents to continue positive behaviour change. ACTRN12610000200088. © 2015 World Obesity.

Implementing a complex rehabilitation intervention in a stroke trial: a qualitative process evaluation of AVERT

Directory of Open Access Journals (Sweden)

Julie A Luker

2016-05-01

Full Text Available Abstract Background The implementation of multidisciplinary stroke rehabilitation interventions is challenging, even when the intervention is evidence-based. Very little is known about the implementation of complex interventions in rehabilitation clinical trials. The aim of study was to better understand how the implementation of a rehabilitation intervention in a clinical trial within acute stroke units is experienced by the staff involved. This qualitative process evaluation was part of a large Phase III stroke rehabilitation trial (AVERT. Methods A descriptive qualitative approach was used. We purposively sampled 53 allied health and nursing staff from 19 acute stroke units in Australia, New Zealand and Scotland. Semi-structured interviews were conducted by phone, voice-internet, or face to face. Digitally recorded interviews were transcribed and analysed by two researchers using rigorous thematic analysis. Results Our analysis uncovered ten important themes that provide insight into the challenges of implementing complex new rehabilitation practices within complex care settings, plus factors and strategies that assisted implementation. Themes were grouped into three main categories: staff experience of implementing the trial intervention, barriers to implementation, and overcoming the barriers. Participation in the trial was challenging but had personal rewards and improved teamwork at some sites. Over the years that the trial ran some staff perceived a change in usual care. Barriers to trial implementation at some sites included poor teamwork, inadequate staffing, various organisational barriers, staff attitudes and beliefs, and patient-related barriers. Participants described successful implementation strategies that were built on interdisciplinary teamwork, education and strong leadership to ‘get staff on board’, and developing different ways of working. Conclusions The AVERT stroke rehabilitation trial required commitment to deliver

A pilot randomised clinical trial of physiotherapy (manual therapy, exercise, and education) for early-onset hip osteoarthritis post-hip arthroscopy.

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Kemp, Joanne; Moore, Kate; Fransen, Marlene; Russell, Trevor; Freke, Matthew; Crossley, Kay M

2018-01-01

Despite the increasing use of hip arthroscopy for hip pain, there is no level 1 evidence to support physiotherapy rehabilitation programs following this procedure. The aims of this study were to determine (i) what is the feasibility of a randomised controlled trial (RCT) investigating a targeted physiotherapy intervention for early-onset hip osteoarthritis (OA) post-hip arthroscopy? and (ii) what are the within-group treatment effects of the physiotherapy intervention and a health-education control group? This study was a pilot single-blind RCT conducted in a private physiotherapy clinic in Hobart, Australia. Patients included 17 volunteers (nine women; age 32 ± 8 years; body mass index = 25.6 ± 5.1 kg/m 2 ) who were recruited 4-14 months post-hip arthroscopy, with chondropathy and/or labral pathology at the time of surgery. Interventions included a physiotherapy treatment program that was semi-standardised and consisted of (i) manual therapy; (ii) hip strengthening and functional retraining; and (iii) health education. Control treatment encompassed individualised health education sessions. The primary outcome measure was feasibility, which was reported as percentage of eligible participants enrolled, adherence with the intervention, and losses to follow-up. The research process was evaluated using interviews, and an estimated sample size for a definitive study is offered. Secondary outcomes included the Hip disability and Osteoarthritis Outcome Score (HOOS) and the International Hip Outcome Tool (IHOT-33) patient-reported outcomes. Seventeen out of 48 eligible patients (35%) were randomised. Adherence to the intervention was 100%, with no losses to follow-up. The estimated sample size for a full-scale RCT was 142 patients. The within-group (95% confidence intervals) change scores for the physiotherapy group were HOOS-Symptoms 6 points (-4 to 16); HOOS-Pain 10 points (-2 to 22); HOOS-Activity of Daily Living 8 points (0 to 16); HOOS-Sport 3 points

Perioperative hyperoxia - Long-term impact on cardiovascular complications after abdominal surgery, a post hoc analysis of the PROXI trial

DEFF Research Database (Denmark)

Fonnes, Siv; Gogenur, Ismail; Sondergaard, Edith Smed

2016-01-01

BACKGROUND: Increased long-term mortality was found in patients exposed to perioperative hyperoxia in the PROXI trial, where patients undergoing laparotomy were randomised to 80% versus 30% oxygen during and after surgery. This post hoc follow-up study assessed the impact of perioperative hyperoxia...... included myocardial infarction, other heart disease, and acute coronary syndrome or death. Data were analysed in the Cox proportional hazards model. RESULTS: The primary outcome, acute coronary syndrome, occurred in 2.5% versus 1.3% in the 80% versus 30% oxygen group; HR 2.15 (95% CI 0.96-4.84). Patients...

Systematic literature review of clinical trials evaluating pharmacotherapy for overactive bladder in elderly patients: An assessment of trial quality.

Science.gov (United States)

Kistler, Kristin D; Xu, Yingxin; Zou, Kelly H; Ntanios, Fady; Chapman, Douglass S; Luo, Xuemei

2018-01-01

Overactive bladder (OAB) disproportionately affects older-aged adults, yet most randomized controlled trials (RCTs) underrepresent patients ≥65. This systematic literature review (SLR) identified RCTs evaluating β-3 adrenergic agonists or muscarinic antagonists in elderly patients with OAB, and compared study quality across trials. MEDLINE ® , Embase ® , and Cochrane Collaboration Central Register of Clinical Trials databases were searched from inception through April 28, 2015 to identify published, peer-reviewed RCT reports evaluating β-3 adrenergic agonists or muscarinic antagonists in elderly OAB patients (either ≥65 years or study-described as "elderly"). To assess study quality of RCT reports, we focused on internal/external validity, assessed via two scales: the validated Effective Public Health Practice Project [EPHPP]): Quality Assessment Tool for Quantitative Studies, and a tool commissioned by the Agency for Healthcare Research and Quality (AHRQ). Database searches yielded 1380 records that were then screened according to predefined inclusion/exclusion criteria. We included eight papers meeting study criteria. Despite scientific community efforts to improve RCT reporting standards, published reports still include incomplete and inconsistent reporting-of subject attrition, baseline patient characteristics, inclusion/exclusion criteria, and other important details. Only three of the eight OAB RCTs in this review received quality ratings of Strong (EPHPP) or Fair (AHRQ) and were multicenter with large samples. Despite the prevalence of OAB among older age individuals, relatively few RCTs evaluate OAB treatments explicitly among elderly subjects. The findings from this quality assessment suggest some areas for improvement in both conduct and reporting of future RCTs assessing OAB treatment in elderly. © 2017 Wiley Periodicals, Inc.

Evaluation of post-tensioning of a curved continuous girder using long-gauge fiber optic sensors

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Abdel-Jaber, Hiba; Glisic, Branko

2014-03-01

Streicker Bridge is a pedestrian bridge on the Princeton University campus. It consists of a main span and four curved continuous girders (legs). The main span and the southeast leg of the bridge are equipped with fiber optic strain and temperature sensors, allowing the bridge to also function as an on-campus laboratory for the Structural Health Monitoring research group. Parallel sensors were embedded at critical cross-sections in the deck prior to the pouring of concrete. The deck of the southeast leg experienced early age cracking within a few days of concrete pouring, which was detected by the strain sensors. Post-tensioning was then performed and it is assumed that it closed off the cracks. Evaluation of post-tensioning forces is complex due to the existence of the cracks, and this paper researches a procedure to estimate the post-tensioning forces at cracked and uncracked locations. The obtained post-tensioning forces were compared to design forces and conclusions regarding the status of post-tensioning were made. This is important as it gives information on the actual health condition and performance of the structure. It also provides information on the safety of the structure. The objective of this paper is to present a methodology for the evaluation of the post-tensioning force along the deck based on strain measurements. The monitoring system, results, data analysis method, and conclusions regarding the bridge health condition and performance are presented in this paper.

[Establish research model of post-marketing clinical safety evaluation for Chinese patent medicine].

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Zheng, Wen-ke; Liu, Zhi; Lei, Xiang; Tian, Ran; Zheng, Rui; Li, Nan; Ren, Jing-tian; Du, Xiao-xi; Shang, Hong-cai

2015-09-01

The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research.

Type 1 Diabetes TrialNet--an international collaborative clinical trials network.

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Skyler, Jay S; Greenbaum, Carla J; Lachin, John M; Leschek, Ellen; Rafkin-Mervis, Lisa; Savage, Peter; Spain, Lisa

2008-12-01

Type 1 Diabetes TrialNet is an international consortium of clinical research centers aimed at the prevention or delay of type 1 diabetes (T1D). The fundamental goal of TrialNet is to counter the T1D disease process by immune modulation and/or enhancement of beta cell proliferation and regeneration. To achieve this goal, TrialNet researchers are working to better understand the natural history of the disease, to identify persons at risk, and to clinically evaluate novel therapies that balance potential risks and benefits. The particular focus is on studies of preventive measures. In addition, TrialNet evaluates therapies in individuals with newly diagnosed T1D with preserved beta cell function to help determine the risk/benefit profile and gain an initial assessment of potential efficacy in preservation of beta cell function, so that promising agents can be studied in prevention trials. In addition, TrialNet evaluates methodologies that enhance the conduct of its clinical trials, which includes tests of outcome assessment methodology, the evaluation of surrogate markers, and mechanistic studies laying the foundation for future clinical trials.

Evaluation of carbohydrate restriction as primary treatment for post-gastric bypass hypoglycemia.

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van Meijeren, Jorick; Timmer, Ilse; Brandts, Hans; Janssen, Ignace; Boer, Hans de

2017-03-01

Up to 15% of patients who have undergone Roux-en-Y gastric bypass (RYGB) surgery may eventually develop symptoms of hypoglycemia. To evaluate the daily life efficacy of a carbohydrate (carb)-restricted dietary advice (CRD) of 6 meals per day with a 30 g carb maximum per meal in patients with documented post-RYGB hypoglycemia. Teaching hospital, the Netherlands. Frequency and severity of hypoglycemic events before and after CRD were assessed retrospectively in 41 patients with documented post-RYGB hypoglycemia, based on medical records and telephone questionnaires. Hypoglycemia was defined as a blood glucose leveltreatment of hypoglycemia, decreased from 23 to 6 (Pmeals per day with up to 30 g carbs each, is an effective treatment of post-RYGB hypoglycemia in the majority of patients. Additional medication is needed in about a third of patients. Copyright © 2017 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

A prospective, randomized, double-blind, placebo-controlled parallel-group dual site trial to evaluate the effects of a Bacillus coagulans-based product on functional intestinal gas symptoms

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2009-01-01

Background This randomized double blind placebo controlled dual site clinical trial compared a probiotic dietary supplement to placebo regarding effects on gastrointestinal symptoms in adults with post-prandial intestinal gas-related symptoms (abdominal pain, distention, flatulence) but no gastrointestinal (GI) diagnoses to explain the symptoms. Methods Sixty-one adults were enrolled (age 36.5 ± 12.6 years; height 165.1 ± 9.2 cm; weight 75.4 ± 17.3 kg) and randomized to either Digestive Advantage™ Gas Defense Formula - (GanedenBC30 Bacillus coagulans GBI-30, 6086): n = 30; or Placebo: n = 31. Study subjects were evaluated every two weeks over a four-week period using validated questionnaires and standard biochemical safety testing. Outcome criteria of interest included change from baseline in Gastrointestinal Symptom Rating Scale (GSRS) abdominal pain, abdominal distention, flatus, and the Severity of Dyspepsia Assessment (SODA) bloating and gas subscores over four weeks of product use. Results Measured against the placebo, subjects in the probiotic group achieved significant improvements in GSRS abdominal pain subscore (p = 0.046) and the GSRS total score (p = 0.048), with a strong trend for improvement on the GSRS abdominal distension subscore (p = 0.061). A strong placebo effect was evident which could explain the lack of statistical significant differences between the groups for many of the efficacy variables. Conclusion In conclusion, the Bacillus coagulans-based product was effective in improving the quality of life and reducing gastrointestinal symptoms in adults with post prandial intestinal gas-related symptoms and no GI diagnoses. Trial Registration ClinicalTrials.gov Identifier: NCT00881322 PMID:19922649

A CLINICAL EVALUATION OF POST-PARTUM DEPRESSION IN COASTAL KARNATAKA

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Annappa Shetty

2016-09-01

Full Text Available BACKGROUND Psychological mood changes, depression is very common in Post-partum period ranging from mild and transient “baby blues” experienced by 50-80% of women to postpartum Psychosis which affects 1% of women. AIMS AND OBJECTIVE To evaluate the association of different factors with Post-Partum depression in coastal Karnataka region, (Karwar. MATERIAL & METHODS  A Prospective study was conducted in the department of Obstetrics and Gynaecology, KAIMS, Karwar, Karnataka.  A total one thousand patients 4-7 Post-partum days were selected and interrogated using Edinburgh Postnatal depression scale (EPDS. Socio-demographic factors (age, Parity, literacy, socio-economic status, marital status and family structure, history of psychiatric disorders and abuse, mode of delivery and the obstetric outcome were recorded. The results were analysed statistically using Chi-square chart. STATISTICAL ANALYSIS AND RESULTS: The incidence of PPD was 22%. Significant association of PPD was seen with low socio-economic status group (P<005, poor literacy (P<0.001, nuclear family structure (P<0.05, single mother (P<0.001, past history of abuse (P<0.05 and poor obstetric outcome (P<0.001. CONCLUSION This study provides useful information about the prevalence of PPD and the association of socio economic, cultural practices prevalent in coastal Karnataka with PPD.

Implementing a complex rehabilitation intervention in a stroke trial: a qualitative process evaluation of AVERT.

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Luker, Julie A; Craig, Louise E; Bennett, Leanne; Ellery, Fiona; Langhorne, Peter; Wu, Olivia; Bernhardt, Julie

2016-05-10

The implementation of multidisciplinary stroke rehabilitation interventions is challenging, even when the intervention is evidence-based. Very little is known about the implementation of complex interventions in rehabilitation clinical trials. The aim of study was to better understand how the implementation of a rehabilitation intervention in a clinical trial within acute stroke units is experienced by the staff involved. This qualitative process evaluation was part of a large Phase III stroke rehabilitation trial (AVERT). A descriptive qualitative approach was used. We purposively sampled 53 allied health and nursing staff from 19 acute stroke units in Australia, New Zealand and Scotland. Semi-structured interviews were conducted by phone, voice-internet, or face to face. Digitally recorded interviews were transcribed and analysed by two researchers using rigorous thematic analysis. Our analysis uncovered ten important themes that provide insight into the challenges of implementing complex new rehabilitation practices within complex care settings, plus factors and strategies that assisted implementation. Themes were grouped into three main categories: staff experience of implementing the trial intervention, barriers to implementation, and overcoming the barriers. Participation in the trial was challenging but had personal rewards and improved teamwork at some sites. Over the years that the trial ran some staff perceived a change in usual care. Barriers to trial implementation at some sites included poor teamwork, inadequate staffing, various organisational barriers, staff attitudes and beliefs, and patient-related barriers. Participants described successful implementation strategies that were built on interdisciplinary teamwork, education and strong leadership to 'get staff on board', and developing different ways of working. The AVERT stroke rehabilitation trial required commitment to deliver an intervention that needed strong collaboration between nurses and

Evaluation of internal peer-review to train nurses recruiting to a randomized controlled trial--Internal Peer-review for Recruitment Training in Trials (InterPReTiT).

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Mann, Cindy; Delgado, Debbie; Horwood, Jeremy

2014-04-01

A discussion and qualitative evaluation of the use of peer-review to train nurses and optimize recruitment practice in a randomized controlled trial. Sound recruitment processes are critical to the success of randomized controlled trials. Nurses recruiting to trials must obtain consent for an intervention that is administered for reasons other than anticipated benefit to the patient. This requires not only patients' acquiescence but also evidence that they have weighed the relevant information in reaching their decision. How trial information is explained is vital, but communication and training can be inadequate. A discussion of a new process to train nurses recruiting to a randomized controlled trial. Literature from 1999-2013 about consenting to trials is included. Over 3 months from 2009-2010, recruiting nurses reviewed recruitment interviews recorded during the pilot phase of a single-site randomized controlled trial and noted content, communication style and interactions. They discussed their findings during peer-review meetings, which were audio-recorded and analysed using qualitative methodology. Peer-review can enhance nurses' training in trial recruitment procedures by supporting development of the necessary communication skills, facilitating consistency in information provision and sharing best practice. Nurse-led peer-review can provide a forum to share communication strategies that will elicit and address participant concerns and obtain evidence of participant understanding prior to consent. Comparing practice can improve consistency and accuracy of trial information and facilitate identification of recruitment issues. Internal peer-review was well accepted and promoted team cohesion. Further evaluation is needed. © 2013 John Wiley & Sons Ltd.

Managing clinical trials

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Kenyon Sara

2010-07-01

Full Text Available Abstract Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists starting out in this important field. For the past three decades, trialists have invented and reinvented the trial management wheel. We suggest that to improve the successful, timely delivery of important clinical trials for patient benefit, it is time to produce standard trial management guidelines and develop robust methods of evaluation.

Registration status and outcome reporting of trials published in core headache medicine journals.

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Rayhill, Melissa L; Sharon, Roni; Burch, Rebecca; Loder, Elizabeth

2015-11-17

To evaluate randomized controlled trial (RCT) registration and outcome reporting compliance in core headache medicine journals. We identified RCTs published in core journals (Headache, Cephalalgia, and the Journal of Headache and Pain) from 2005 through 2014. We searched articles for trial registration numbers, which were verified in the corresponding trial registry. We categorized trial funding sources as industry, academic, government, or mixed. We contacted corresponding authors to assess reasons for nonregistration. We evaluated whether primary outcomes in trial registries matched those in corresponding publications. The journals published 225 RCTs over the study period. Fifty-eight of 225 (26%) reported a trial registration number in the article that could be linked to a corresponding registry entry. Trial registration rates increased over the 9 years of the study. Forty-six of 118 (39%) of industry-funded studies were registered compared with 27% of academic and 0% of government-funded studies. Only 5% of RCTs were prospectively registered, reported primary outcomes identical to those in the trial registry, and did not report unacknowledged post hoc outcomes. The most common reason for nonregistration was lack of awareness. Only about a quarter of the articles published in the core headache medicine journals are compliant with trial registration, but compliance has increased over time. Selective reporting of outcomes remains a problem, and very few trials met all 3 reporting standards assessed in this study. Efforts to improve the quality of trial reporting in the headache literature should continue. © 2015 American Academy of Neurology.

Post-Flight Back Pain Following International Space Station Missions: Evaluation of Spaceflight Risk Factors

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Laughlin, M. S.; Murray, J. D.; Wear, M. L.; Van Baalen, M.

2016-01-01

INTRODUCTION Back pain during spaceflight has often been attributed to the lengthening of the spinal column due to the absence of gravity during both short and long-duration missions. Upon landing and re-adaptation to gravity, the spinal column reverts back to its original length thereby causing some individuals to experience pain and muscular spasms, while others experience no ill effects. With International Space Station (ISS) missions, cases of back pain and injury are more common post-flight, but little is known about the potential risk factors. Thus, the purpose of this project was to perform an initial evaluation of reported post-flight back pain and injury cases to relevant spaceflight risk factors in United States astronauts that have completed an ISS mission. METHODS All US astronauts who completed an ISS mission between Expeditions (EXP) 1 and 41 (2000-2015) were included in this evaluation. Forty-five astronauts (36 males and 9 females) completed 50 ISS missions during the study time period, as 5 astronauts completed 2 ISS missions. Researchers queried medical records of the 45 astronauts for occurrences of back pain and injury. A case was defined as any reported event of back pain or injury to the cervical, thoracic, lumbar, sacral, or coccyx spine regions. Data sources for the cases included the Flight Medicine Clinic's electronic medical record; Astronaut Strength, Conditioning and Rehabilitation electronic documentation; the Private Medical Conference tool; and the Space Medicine Operations Team records. Post-flight cases were classified as an early case if reported within 45 days of landing (R + 45) or a late case if reported from R + 46 to R + 365 days after landing (R + 1y). Risk factors in the astronaut population for back pain include age, sex, prior military service, and prior history of back pain. Additionally, spaceflight specific risk factors such as type of landing vehicle and onboard exercise countermeasures were included to evaluate their

Recruiting faith- and non-faith-based schools, adolescents and parents to a cluster randomised sexual-health trial: experiences, challenges and lessons from the mixed-methods Jack Feasibility Trial.

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Aventin, Áine; Lohan, Maria; Maguire, Lisa; Clarke, Mike

2016-07-29

The move toward evidence-based education has led to increasing numbers of randomised trials in schools. However, the literature on recruitment to non-clinical trials is relatively underdeveloped, when compared to that of clinical trials. Recruitment to school-based randomised trials is, however, challenging, even more so when the focus of the study is a sensitive issue such as sexual health. This article reflects on the challenges of recruiting post-primary schools, adolescent pupils and parents to a cluster randomised feasibility trial of a sexual-health intervention, and the strategies employed to address them. The Jack Trial was funded by the UK National Institute for Health Research. It comprised a feasibility study of an interactive film-based sexual-health intervention entitled If I Were Jack, recruiting over 800 adolescents from eight socio-demographically diverse post-primary schools in Northern Ireland. It aimed to determine the facilitators and barriers to recruitment and retention to a school-based sexual-health trial and identify optimal multi-level strategies for an effectiveness study. As part of an embedded process evaluation, we conducted semi-structured interviews and focus groups with principals, vice-principals, teachers, pupils and parents recruited to the study as well as classroom observations and a parents' survey. With reference to social learning theory, we identified a number of individual-, behavioural- and environmental-level factors that influenced recruitment. Commonly identified facilitators included perceptions of the relevance and potential benefit of the intervention to adolescents, the credibility of the organisation and individuals running the study, support offered by trial staff, and financial incentives. Key barriers were prior commitment to other research, lack of time and resources, and perceptions that the intervention was incompatible with pupil or parent needs or the school ethos. Reflecting on the methodological

A Randomized Controlled Trial of Mindfulness Meditation for Chronic Insomnia

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Ong, Jason C.; Manber, Rachel; Segal, Zindel; Xia, Yinglin; Shapiro, Shauna; Wyatt, James K.

2014-01-01

Study Objectives: To evaluate the efficacy of mindfulness meditation for the treatment of chronic insomnia. Design: Three-arm, single-site, randomized controlled trial. Setting: Academic medical center. Participants: Fifty-four adults with chronic insomnia. Interventions: Participants were randomized to either mindfulness-based stress reduction (MBSR), mindfulness-based therapy for insomnia (MBTI), or an eight-week self-monitoring (SM) condition. Measurements and Results: Patient-reported outcome measures were total wake time (TWT) from sleep diaries, the pre-sleep arousal scale (PSAS), measuring a prominent waking correlate of insomnia, and the Insomnia Severity Index (ISI) to determine remission and response as clinical endpoints. Objective sleep measures were derived from laboratory polysomnography and wrist actigraphy. Linear mixed models showed that those receiving a meditation-based intervention (MBSR or MBTI) had significantly greater reductions on TWT minutes (43.75 vs 1.09), PSAS (7.13 vs 0.16), and ISI (4.56 vs 0.06) from baseline-to-post compared to SM. Post hoc analyses revealed that each intervention was superior to SM on each of the patient-reported measures, but no significant differences were found when comparing MBSR to MBTI from baseline-to-post. From baseline to 6-month follow-up, MBTI had greater reductions in ISI scores than MBSR (P insomnia and could provide an alternative to traditional treatments for insomnia. Trial Registration: Mindfulness-Based Approaches to Insomnia: clinicaltrials.gov, identifier: NCT00768781 Citation: Ong JC, Manber R, Segal Z, Xia Y, Shapiro S, Wyatt JK. A randomized controlled trial of mindfulness meditation for chronic insomnia. SLEEP 2014;37(9):1553-1563. PMID:25142566

Pharmacist leadership in ICU quality improvement: coordinating spontaneous awakening and breathing trials.

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Stollings, Joanna L; Foss, Julie J; Ely, E Wesley; Ambrose, Anna M; Rice, Todd W; Girard, Timothy D; Wheeler, Arthur P

2015-08-01

Coordinating efforts across disciplines in the intensive care unit is a key component of quality improvement (QI) efforts. Spontaneous awakening trials (SATs) and spontaneous breathing trials (SBTs) are considered key components of guidelines, yet unfortunately are often not done or coordinated properly. To determine if a pharmacist-driven awakening and breathing coordination (ABC) QI program would improve compliance (ie, process measures) as compared with the previous protocol, which did not involve pharmacists. The QI program included pharmacist-led education, daily discussion on rounds, and weekly performance reports to staff. Using a pre-QI versus during-QI versus post-QI intervention design, we compared data from 500 control ventilator-days (pre-QI period) versus 580 prospective ventilator-days (during-QI period). We then evaluated the sustainability of the QI program in 216 ventilator-days in the post-QI period. SAT safety screens were performed on only 20% pre-QI patient-days versus 97% of during-QI patient-days (P improved process measures compliance, comparing the pre-QI versus during-QI rates of screening, performing, and coordinating SAT and SBTs, and these results were sustained in the 8-month follow-up period post-QI program. © The Author(s) 2015.

Early versus delayed post-operative bathing or showering to prevent wound complications.

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Toon, Clare D; Sinha, Sidhartha; Davidson, Brian R; Gurusamy, Kurinchi Selvan

2015-07-23

Many people undergo surgical operations during their life-time, which result in surgical wounds. After an operation the incision is closed using stiches, staples, steri-strips or an adhesive glue. Usually, towards the end of the surgical procedure and before the patient leaves the operating theatre, the surgeon covers the closed surgical wound using gauze and adhesive tape or an adhesive tape containing a pad (a wound dressing) that covers the surgical wound. There is currently no guidance about when the wound can be made wet by post-operative bathing or showering. Early bathing may encourage early mobilisation of the patient, which is good after most types of operation. Avoiding post-operative bathing or showering for two to three days may result in accumulation of sweat and dirt on the body. Conversely, early washing of the surgical wound may have an adverse effect on healing, for example by irritating or macerating the wound, and disturbing the healing environment. To compare the benefits (such as potential improvements to quality of life) and harms (potentially increased wound-related morbidity) of early post-operative bathing or showering (i.e. within 48 hours after surgery, the period during which epithelialisation of the wound occurs) compared with delayed post-operative bathing or showering (i.e. no bathing or showering for over 48 hours after surgery) in patients with closed surgical wounds. We searched The Cochrane Wounds Group Specialised Register (30th June 2015); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); The Database of Abstracts of Reviews of Effects (DARE) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; EBSCO CINAHL; the metaRegister of Controlled Trials (mRCT) and the International Clinical Trials Registry Platform (ICTRP). We considered all randomised trials conducted in patients who had undergone any surgical procedure and had surgical closure of

[Discussion on development of four diagnostic information scale for clinical re-evaluation of postmarketing herbs].

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He, Wei; Xie, Yanming; Wang, Yongyan

2011-12-01

Post-marketing re-evaluation of Chinese herbs can well reflect Chinese medicine characteristics, which is the most easily overlooked the clinical re-evaluation content. Since little attention has been paid to this, study on the clinical trial design method was lost. It is difficult to improving the effectiveness and safety of traditional Chinese medicine. Therefore, more attention should be paid on re-evaluation of the clinical trial design method point about tcm syndrome such as the type of research program design, the study of Chinese medical information collection scale and statistical analysis methods, so as to improve the clinical trial design method study about tcm syndrome of Chinese herbs postmarketing re-evalutation status.

Effect of Submucosal Injection of Dexamethasone on Post-operative Sequelae of Third Molar Surgery

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S P Deo

2011-06-01

Full Text Available Introduction: This study was carried out to evaluate the effects of a single pre-operative sub-mucosal injection of dexamethasone after third molar surgery to see the effects on post-operative discomfort. Methods: This study was a prospective, double-blind, randomized, clinical trial. The subjects were forty patients who underwent surgical removal of the mandibular impacted third molar under local anesthesia and after being randomly assigned to receive either an 8 mg dexamethasone as submucosal injection or a normal saline injection into the lower buccal vestibule adjacent to the third molar. The maximum interincisal distance and facial contours were measured at the baseline and post-surgically on Day 2 and 7. Post-operative pain was evaluated subjectively using a visual analog scale and objectively by counting the number of analgesic tablets used. All subjects were operated upon by the same investigator to minimize the difference from inter-operator variability. Results: There was a signicant difference in the measurements of the degree of swelling and trismus between the two groups on the 2nd post-operative day. In contrast, there was no statistically signicant difference between the groups on the 7th post-operative day. The test group also used fewer analgesics post-operatively. Conclusions: Submucosal injection of dexamethasone after third molar surgery is effective in reducing postoperative swelling and trismus. It also delays the onset of post-operative pain. Keywords: dexamethasone, submucosal injection, third molar, third molar surgery, third molar extraction

The effects of neuromuscular exercise on medial knee joint load post-arthroscopic partial medial meniscectomy: 'SCOPEX', a randomised control trial protocol

DEFF Research Database (Denmark)

Hall, Michelle; Hinman, Rana S; Wrigley, Tim V

2012-01-01

Meniscectomy is a risk factor for knee osteoarthritis, with increased medial joint loading a likely contributor to the development and progression of knee osteoarthritis in this group. Therefore, post-surgical rehabilitation or interventions that reduce medial knee joint loading have the potential...... to reduce the risk of developing or progressing osteoarthritis. The primary purpose of this randomised, assessor-blind controlled trial is to determine the effects of a home-based, physiotherapist-supervised neuromuscular exercise program on medial knee joint load during functional tasks in people who have...

Pre- and post-operative evaluations of eight dogs following right nephrectomy due to Dioctophyma renale.

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Mesquita, L R; Rahal, S C; Faria, L G; Takahira, R K; Rocha, N S; Mamprim, M J; Oliveira, H S

2014-01-01

Dioctophyma renale is a large nematode distributed worldwide that may cause progressive and severe destruction of renal parenchyma. The present study aimed to evaluate pre- and post-operatively dogs submitted to right nephrectomy due to D. renale and to assess the histopathological damage of the removed kidney. Eight crossbred dogs, aged from 12 to 48 months that were unilaterally nephrectomized due to the presence of D. renale were evaluated. Physical examination, urinalysis, complete blood count, serum biochemistry, and abdominal ultrasound were performed immediately before and one month after nephrectomy. The nephrectomized right kidneys were submitted to macroscopic and microscopic evaluations. Urinalysis preoperatively detected occult blood in all dogs and D. renale eggs in five cases. Complete blood count showed all parameters within the reference range, except one dog post-operatively. Serum biochemistry performed before and after surgery verified that urea, creatinine and sodium were within the reference range values in all dogs. Other findings varied among the dogs. The length and arterial resistive index mean values of the left kidney were similar pre- and post-operatively. Thus, the inconsiderable change in laboratory findings pre- and post-operatively was attributable to compensation by left kidney function for the removed abnormal right kidney. Right kidney histology revealed chronic nephropathy due to D. renale. Imaging diagnosis should be performed on dogs suspected as carrying the disease or on those from an enzootic area since the laboratory findings are not specific except eggs in the urine.

Evaluation of a Decision Aid for Women with Epilepsy Who Are Considering Pregnancy: A Randomized Controlled Trial.

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McGrath, Amanda; Sharpe, Louise; Lah, Suncica; Parratt, Kaitlyn

2017-07-01

For many women with epilepsy (WWE), decision making about pregnancy is complicated by considerations such as the potential teratogenicity of antiepileptic drugs, offspring risk of epilepsy, seizure occurrence during pregnancy, and the challenges of parenting amidst poorly controlled seizures. This proof-of-concept, randomized controlled trial aimed to evaluate a decision aid (DA) developed to help WWE decide if they should start or enlarge their families. Seventy-nine WWE of childbearing age were recruited from Epilepsy Action Australia between October and November 2013 and randomized to receive the intervention (the DA) or not, and to complete a set of questionnaires pre- and post- intervention. The DA, delivered as a PDF booklet, provided balanced evidence-based information about options, risks and benefits, including probabilities; as well as steps for clarifying values and considering options within one's personal situation. Compared with the control group, the DA group had statistically significant improvements in knowledge about pregnancy and epilepsy (Cohen's d = 1.24; 95%CI = 0.77 to 1.83) and reduced decisional conflict (Cohen's d = 0.59; 95%CI = 0.21 to 0.99). Changes in decision self-efficacy, certainty of choice, patient-practitioner communication abilities and value congruence with choice were comparable between the DA and control group. Importantly, women's decisions about motherhood were not biased towards either direction, and there were no adverse effects on depression or anxiety. All women who received the DA indicated they would recommend it to other WWE. The DA has the potential to serve as a useful support tool for WWE who are considering motherhood. Future research is needed to test the DA in clinical settings with guidance from a health professional. The trial was registered with the Australian New Zealand Clinical Trials Registry (ID ACTRN12613001082796).

The effect of post-exercise hydrotherapy on subsequent exercise performance and heart rate variability.

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Stanley, Jamie; Buchheit, Martin; Peake, Jonathan M

2012-03-01

We investigated the effect of hydrotherapy on time-trial performance and cardiac parasympathetic reactivation during recovery from intense training. On three occasions, 18 well-trained cyclists completed 60 min high-intensity cycling, followed 20 min later by one of three 10-min recovery interventions: passive rest (PAS), cold water immersion (CWI), or contrast water immersion (CWT). The cyclists then rested quietly for 160 min with R-R intervals and perceptions of recovery recorded every 30 min. Cardiac parasympathetic activity was evaluated using the natural logarithm of the square root of mean squared differences of successive R-R intervals (ln rMSSD). Finally, the cyclists completed a work-based cycling time trial. Effects were examined using magnitude-based inferences. Differences in time-trial performance between the three trials were trivial. Compared with PAS, general fatigue was very likely lower for CWI (difference [90% confidence limits; -12% (-18; -5)]) and CWT [-11% (-19; -2)]. Leg soreness was almost certainly lower following CWI [-22% (-30; -14)] and CWT [-27% (-37; -15)]. The change in mean ln rMSSD following the recovery interventions (ln rMSSD(Post-interv)) was almost certainly higher following CWI [16.0% (10.4; 23.2)] and very likely higher following CWT [12.5% (5.5; 20.0)] compared with PAS, and possibly higher following CWI [3.7% (-0.9; 8.4)] compared with CWT. The correlations between performance, ln rMSSD(Post-interv) and perceptions of recovery were unclear. A moderate correlation was observed between ln rMSSD(Post-interv) and leg soreness [r = -0.50 (-0.66; -0.29)]. Although the effects of CWI and CWT on performance were trivial, the beneficial effects on perceptions of recovery support the use of these recovery strategies.

The evaluation of a trial of syringe vending machines in Canberra, Australia.

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McDonald, David

2009-07-01

Syringe vending machines (SVMs) have been trialled in Canberra, Australian Capital Territory, Australia, as an intervention aiming to increase the availability of sterile injecting equipment for use by IDUs. This study evaluated the 12-month trial. A utilisation-focused evaluation model, with both formative and summative components, was employed. Four SVMs were installed, each dispensing packs containing four 1 mL syringes and associated injecting paraphernalia. The trial participants were the clients of the SVMs and other key informants. The core measurements used were the number of syringes dispensed in Canberra by SVMs and other outlets, SVM clients' demographics and experiences of and attitudes towards SVMs, perceived impacts of SVMs on needle sharing, unsafe disposal of used syringes in the vicinity of SVMs, and community and stakeholder attitudes. The trial was implemented successfully, with no adverse consequences identified. The SVMs appear to be serving both the usual clients of the other outlets for sterile injecting equipment (community pharmacies and the Needle Syringe Program outlets) and others who are reluctant to use such outlets or find them inconvenient. The out-of-business-hours provision of syringes through the SVMs was particularly welcomed by both SVM clients and other stakeholders. The continuing operation of the initial four SVMs is widely supported, and additional machines are requested by clients and others. Owing to the success of the trial in terms of feasibility and outcomes for both IDUs and for the broader community, it is desirable that providing sterile injecting equipment through SVMs continues and be expanded as an integral component of harm reduction strategies.

The dynamics of success and failure: how post-behaviour evaluations relate to subsequent exercise intentions and behaviour.

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Kwan, Bethany M; Bryan, Angela D; Sheeran, Paschal

2018-01-25

Exercise behaviour change involves multiple experiences with success and failure. The Model of Action Phases (MAP) offers a dynamic account of how success and failure influence both immediate evaluations and future decisions and actions. However, predictions from the MAP have not been formally tested. A longitudinal daily diary study was used to examine how post-behaviour evaluations of exercise success and failure influence subsequent exercise intentions and behaviour. Participants (N = 104) set exercise goals, and then kept a daily online exercise diary for four weeks. Participants self-reported exercise behaviour, affective response to exercise, self-evaluations after success or failure at following through on intentions to exercise, and intentions to exercise in the next week. Multilevel modelling revealed significant within- and between-participant relationships among post-behaviour evaluations, intentions and subsequent behaviour. Findings supported MAP-derived predictions about how success and failure at exercise are associated with feelings about exercise and the self, and inform subsequent exercise intentions and behaviour. Positive post-behaviour evaluations of success or failure may stabilise positive intentions and aid maintenance of exercise behaviour. Implications of these MAP-based findings for intervention design are discussed.

Evaluation of a cloud-based local-read paradigm for imaging evaluations in oncology clinical trials for lung cancer

International Nuclear Information System (INIS)

Sueoka-Aragane, Naoko; Kobayashi, Naomi; Bonnard, Eric; Charbonnier, Colette; Yamamichi, Junta; Mizobe, Hideaki; Kimura, Shinya

2015-01-01

Although tumor response evaluated with radiological imaging is frequently used as a primary endpoint in clinical trials, it is difficult to obtain precise results because of inter- and intra-observer differences. To evaluate usefulness of a cloud-based local-read paradigm implementing software solutions that standardize imaging evaluations among international investigator sites for clinical trials of lung cancer. Two studies were performed: KUMO I and KUMO I Extension. KUMO I was a pilot study aiming at demonstrating the feasibility of cloud implementation and identifying issues regarding variability of evaluations among sites. Chest CT scans at three time-points from baseline to progression, from 10 patients with lung cancer who were treated with EGFR tyrosine kinase inhibitors, were evaluated independently by two oncologists (Japan) and one radiologist (France), through a cloud-based software solution. The KUMO I Extension was performed based on the results of KUMO I. KUMO I showed discordance rates of 40% for target lesion selection, 70% for overall response at the first time-point, and 60% for overall response at the second time-point. Since the main reason for the discordance was differences in the selection of target lesions, KUMO I Extension added a cloud-based quality control service to achieve a consensus on the selection of target lesions, resulting in an improved rate of agreement of response evaluations. The study shows the feasibility of imaging evaluations at investigator sites, based on cloud services for clinical studies involving multiple international sites. This system offers a step forward in standardizing evaluations of images among widely dispersed sites

Evaluation of an interprofessional educational curriculum pilot course for practitioners working with post-stroke patients.

Science.gov (United States)

Olaisen, Rho Henry; Mariscal-Hergert, Cheryl; Shaw, Alissa; Macchiavelli, Cecilia; Marsheck, Joanna

2014-03-01

This report describes the design and evaluation of an interprofessional pilot training course aimed at pre-licensure practitioners working with post-stroke patients in community-based settings. The course was developed by community-based practitioners from nine health professions. Course learning activities included traditional methods (lectures) and interactive modules (problem-based learning and exchange-based learning). The study's aim was to assess the program's effectiveness in adapting and incorporating knowledge, skills and self-confidence when delivering tertiary care in therapeutic pool environments; gauge adoption of course principles into practice, and assess overall course satisfaction. Methods of evaluation included conceptual mapping of course format, pre- and post-questionnaires, daily reflection questionnaires, course satisfaction survey and adoption survey, 10 weeks follow-up. Overall, the findings indicate students' knowledge, skills and self-confidence in delivering effective post-stroke care increased following the training. Students reported adopting clinical practices in 10 weeks follow-up. Implications for designing interprofessional curricula are discussed.

Disseminating results to clinical trial participants: a qualitative review of patient understanding in a post-trial population.

Science.gov (United States)

Darbyshire, Julie Lorraine; Price, Hermione Clare

2012-01-01

To identify the most appropriate format for results dissemination to maximise understanding of trial results. Qualitative. Of the original 58 4-T trial centres, 34 agreed to take part in this ancillary research. All participants from these centres were eligible. All 343 participants were sent questionnaires. The low response rate meant that we were unable to make any firm conclusions about the patients' preferred method of dissemination; however, we were able to comment on the level of understanding demonstrated by the trial participants. All 40 (12%) returned questionnaires were received from 15 centres. We received no questionnaires from over half of the centres. The questionnaires which were returned demonstrated broad satisfaction with the results letter, general enthusiasm for the trial and a variable level of understanding of the results; however, there was a high proportion of responders who were not clear on why the research was undertaken or what the results meant. The low response rate may be related to delays during the trial set-up process suggesting that interest in a study quickly wanes for both patients and centres. From this we deduce that rapid dissemination of results is needed if it is to have any impact at all. The responders are likely to reflect a biased cohort who were both enthusiastic about the research and who had a good experience during their 3 years in the 4-T trial. It is perhaps not surprising therefore that the overview is positive. That this population was still not fully informed about the purpose of the research would seem to confirm a low level of understanding among the general public which we suggest should be addressed during the consent process.

Preclinical evaluation of VIS513, a therapeutic antibody against dengue virus, in non-human primates.

Science.gov (United States)

Ong, Eugenia Z; Budigi, Yadunanda; Tan, Hwee Cheng; Robinson, Luke N; Rowley, Kirk J; Winnett, Alexander; Hobbie, Sven; Shriver, Zachary; Babcock, Gregory J; Ooi, Eng Eong

2017-08-01

Despite useful in vivo activity, no therapeutic against dengue virus (DENV) has demonstrated efficacy in clinical trials. Herein, we explored dosing and virological endpoints to guide the design of human trials of VIS513, a pan-serotype anti-DENV IgG1 antibody, in non-human primates (NHPs). Dosing VIS513 pre- or post-peak viremia in NHPs neutralized infectious DENV although RNAemia remained detectable post-treatment; differential interaction of human IgGs with macaque Fc-gamma receptors may delay clearance of neutralized DENV. Our findings suggest useful antiviral utility of VIS513 and highlight an important consideration when evaluating virological endpoints of trials for anti-DENV biologics. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

The fate of prospective spine studies registered on www.ClinicalTrials.gov.

Science.gov (United States)

Ohnmeiss, Donna D

2015-03-01

invitation, 13 not yet recruiting, 18 terminated, 4 withdrawn, and 1 suspended. Among the 72 studies indicated to be completed, 28 (38.9%) have been published. The mean time to publish was 27.9 months from the date of completion. Among unpublished studies, the mean length of time from study completion to the preparation of this article was 62.0 months. There was no difference in the likelihood of publication based on the geographic region of study origin or whether the study was registered before or after initiation. There were statistically significant relationships between the publication rate and the funding type as well as the research type (preporting a 22.8% publication rate for arthroplasty trials and 43.2% for orthopedic trauma trials. In addition to ClinicalTrials.gov Web site fulfilling its original goal of providing patients information about clinical studies, it can also provide a means of tracking publication of prospective studies, changes to protocols, matching publication content to posted study design, and others and raise queries concerning the reasons for not publishing what appear to be well-designed studies. The posting of spine studies before initiation can increase transparency and ability to evaluate clinical trials in spine. Copyright © 2015 Elsevier Inc. All rights reserved.

A post hoc assessment of duration of protection in CAPiTA (Community Acquired Pneumonia immunization Trial in Adults)

NARCIS (Netherlands)

Patterson, Scott; Webber, Chris; Patton, Michael; Drews, Wayne; Huijts, Susanne M.; Bolkenbaas, Marieke; Gruber, William C.; Scott, Daniel A.; Bonten, Marc J M

2016-01-01

Background: The Community Acquired Pneumonia immunization Trial in Adults (CAPiTA) was conducted to evaluate 13-valent pneumococcal conjugate vaccine (PCV13) for the prevention of vaccine-type community-acquired pneumonia (VT-CAP) and vaccine-type invasive pneumococcal disease (VT-IPD) in adults

Does the effect of one-day simulation team training in obstetric emergencies decline within one year? A post-hoc analysis of a multicentre cluster randomised controlled trial

NARCIS (Netherlands)

van de Ven, J.; Fransen, A F; Schuit, E.; van Runnard Heimel, P.J.; Mol, Ben W.; Oei, Swan G.

2017-01-01

Does the effect of one-day simulation team training in obstetric emergencies decline within one year? A post-hoc analysis of a multicentre cluster randomised controlled trial. J van de Ven, AF Fransen, E Schuit, PJ van Runnard Heimel, BW Mol, SG Oei Objective To investigate whether the effect of a

An algorithm for evaluating the ethics of a placebo-controlled trial.

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Amdur, R J; Biddle, C J

2001-10-20

The purpose of this article is to clarify the decision points that are important to consider when evaluating the ethics of a placebo-controlled trial. The ethical requirements for research involving human subjects are reviewed, and the rationale for and potential problems with concomitant placebo control are explained. A series of case discussions are used to illustrate each decision point. The critical decision points in the evaluation of the ethics of a placebo-controlled trial are as follows: (i) Is placebo being used in place of standard therapy? (ii) Is standard therapy likely to be effective? (iii) Is the toxicity of standard therapy such that patients routinely refuse this treatment? (iv) Could the use of placebo result in severe suffering or irreversible harm? (v) Is the variability in the placebo response such that it is reasonable to consider other options for the control group? (vi) Would a reasonable person with an average degree of altruism and risk aversiveness agree to participate in this study? The algorithm presented in this article gives researchers and research monitors (such as Institutional Review Board members) the tools they need to evaluate the ethics of a study that uses concomitant placebo control. Copyright 2001 Wiley-Liss, Inc.

Malignant pleural mesothelioma: a phase II trial with docetaxel.

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Vorobiof, D A; Rapoport, B L; Chasen, M R; Abratt, R P; Cronje, N; Fourie, L; McMichael, G; Hacking, D

2002-03-01

Current cytotoxic therapy has been of limited benefit to patients with malignant pleural mesothelioma. Single agent chemotherapy has been extensively evaluated in small series of phase II clinical trials, with disappointing responses. Docetaxel, an effective taxane in the treatment of advanced breast cancer and non-small-cell lung cancer, was administered intravenously at a dose of 100 mg/m2 every 3 weeks to 30 chemotherapy naive patients with malignant pleural mesothelioma in a prospective multi-institutional phase II clinical trial. An objective response rate (partial responses) of 10% was documented. Additionally, 21% of the patients had minor responses (intention-to-treat analysis). Three patients died within 2 weeks post-first cycle of therapy, although only one patient's death was directly attributed to the investigational drug, whilst in the majority of the patients, manageable and treatable toxicities were encountered. In this phase II clinical trial, docetaxel proved to be mildly effective in the treatment of patients with malignant pleural mesothelioma.

Economic evaluation of a bio-psycho-social intervention for comorbid disorders in a traumatized population in post-war Kosovo

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Wei-Lun Chang

2018-02-01

Full Text Available Objective: Post-hoc economic evaluation of a bio-psycho-social intervention in post-war Kosovo from a societal perspective. Design: Cost-effectiveness analysis, cost-utility analysis, and partial cost-benefit analysis using data from a randomized controlled trial. Patients: Thirty-four torture/war victims with comorbid conditions enrolled in 2012–2013. Methods: Participants were randomly assigned to an “intervention” and a “waiting-list” group. Changes in mental, emotional and physical health and functional impairment were assessed before and after treatment, along with increase in labour income as a proxy for productivity gain. The cost of an extra unit of effectiveness and an additional quality-adjusted life year were calculated. Results: The total cost per participant was €1,322 including, or €1,019 excluding, research costs. Wide variations in costs of changes in mental, emotional and physical effectiveness were demonstrated. Multidisciplinary intervention resulted in functional improvement at a cost of €10,508 per quality-adjusted life year gained. With a mean monthly income increase to €133 (18% after intervention, the intervention cost per participant would be equal to the total increase in monthly income after 4–5 years, assuming the increased level is maintained. Conclusion: Socio-economic benefit associated with quality-adjusted life year gain is shown, although the cost of an additional quality-adjusted life year is above the World Health Organization cost-effectiveness threshold.

Likelihood-based methods for evaluating principal surrogacy in augmented vaccine trials.

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Liu, Wei; Zhang, Bo; Zhang, Hui; Zhang, Zhiwei

2017-04-01

There is growing interest in assessing immune biomarkers, which are quick to measure and potentially predictive of long-term efficacy, as surrogate endpoints in randomized, placebo-controlled vaccine trials. This can be done under a principal stratification approach, with principal strata defined using a subject's potential immune responses to vaccine and placebo (the latter may be assumed to be zero). In this context, principal surrogacy refers to the extent to which vaccine efficacy varies across principal strata. Because a placebo recipient's potential immune response to vaccine is unobserved in a standard vaccine trial, augmented vaccine trials have been proposed to produce the information needed to evaluate principal surrogacy. This article reviews existing methods based on an estimated likelihood and a pseudo-score (PS) and proposes two new methods based on a semiparametric likelihood (SL) and a pseudo-likelihood (PL), for analyzing augmented vaccine trials. Unlike the PS method, the SL method does not require a model for missingness, which can be advantageous when immune response data are missing by happenstance. The SL method is shown to be asymptotically efficient, and it performs similarly to the PS and PL methods in simulation experiments. The PL method appears to have a computational advantage over the PS and SL methods.

Cavity disinfection in minimally invasive dentistry - comparative evaluation of Aloe vera and propolis: A randomized clinical trial

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A R Prabhakar

2015-01-01

Full Text Available Context: The survival of atraumatic restorative treatment (ART restorations would probably increase if near total elimination of cariogenic microorganisms could be done in the process of cavity cleaning before going ahead with the restoration. Thus, use of naturally occurring disinfecting agents for achieving this goal could herald a new beginning in the field of contemporary minimum intervention dentistry. Aims: To evaluate the efficacy of hand instruments in excavating dental caries and comparatively evaluate the roles of Aloe vera and propolis as potential cavity disinfecting agents after minimally invasive hand excavation of dental caries. Settings and Designs: Experimental, in vivo intergroup split mouth, randomized clinical trial. Subjects and Methods: The study included Group I (Control, Group II (A. vera and Group III (propolis. Ten patients with three teeth each have occlusal/occlusoproximal lesions suitable for ART were selected. Dentinal samples were collected three times from each tooth viz., preexcavation, postexcavation and postdisinfection of the cavities. These dentinal samples were subjected to microbiological analyses for total viable count. Statistical Analysis Used: Repeated measures of analysis of variance (ANOVA with Bonferroni post-hoc test and one-way ANOVA with Tukey post-hoc test. Results: In all the three groups, significant amount of bacteria were left behind after hand excavation. Group II and Group III, in which cavities were treated with A. vera and propolis extracts respectively, showed a significant reduction in the bacterial counts when compared to control the group. Conclusions: Hand excavation alone does not completely eliminate bacteria, which may predispose treated teeth to secondary caries. Both propolis and A. vera extracts can be used as potential natural disinfecting agents, thereby embracing the concept of phytotherapy in minimum intervention dentistry.

Lavender essence for post-cesarean pain.

Science.gov (United States)

Hadi, Niaz; Hanid, Ali Akbar

2011-06-01

Post cesarean (CS) pain is a challenging problem for the obstetricians, because it may interfere with mother and baby's well-being. Many approaches have been ever proposed to diminish this pain, each one with particular benefits and limitations. Aromatherapy is a complementary therapy especially for controlling pain. This study aimed at evaluating the effect of lavender essence on post CS pain. In a single-blind clinical trial, 200 term pregnant women with planned elective CS were recruited in a 12 month period of time. They were randomized in two 100-patient groups; received either lavender essence (the case group) or a similar clinically neutral aromatic material (the control group) thorough oxygen mask for 3 min 3 h after receiving similar intravenous analgesics. The Visual Analogue Scale (VAS) was employed to determine the level of post CS pain. The VAS was documented half hour after first intervention. Eight and 16 h later, the aromatherapy was repeated and half hour after each intervention, corresponding VAS was documented. The two groups were matched for demographics and obstetrical history. The baseline VAS was comparable between the two groups. The mean VAS decreased significantly by 16 h after the first intervention in both groups (p aromatherapy by using lavender essence is a successful and safe complementary therapy in reducing pain after CS.

Trial occlusion to assess the risk of persistent pulmonary arterial hypertension after closure of a large patent ductus arteriosus in adolescents and adults with elevated pulmonary artery pressure.

Science.gov (United States)

Zhang, Duan-Zhen; Zhu, Xian-Yang; Lv, Bei; Cui, Chun-Sheng; Han, Xiu-Min; Sheng, Xiao-Tang; Wang, Qi-Guang; Zhang, Po

2014-08-01

No method is available to predict whether patients with patent ductus arteriosus (PDA) and severe pulmonary arterial hypertension (PAH) will show persistent postprocedural PAH (PP-PAH) after PDA closure. This study evaluated the usefulness of trial occlusion for predicting PP-PAH after transcatheter PDA closure in patients with severe PAH. Trial occlusion was performed in 137 patients (age ≥12 years) with PDA and severe PAH. All patients undergoing trial occlusion had a mean pulmonary artery pressure ≥45 mm Hg, pulmonary:systemic flow (Qp/Qs) ratio >1.5, and pulmonary:systemic resistance (Rp/Rs) ratio closure. Linear correlation analysis revealed weak or moderate relationships between the baseline and post-trial pulmonary artery pressures and pulmonary:systemic pressure (Pp/Ps) ratios. Patients were followed up for 1 to 10 years (median: 5 years). PP-PAH (systolic pulmonary artery pressure >50 mm Hg by Doppler echocardiography) was detected in 17 patients (13%), who displayed no significant differences in sex and age compared with patients without PP-PAH. According to discriminant analysis, the strongest discriminators between patients with and without PP-PAH were the baseline left ventricular end-diastolic volume and the baseline and post-trial systolic Pp/Ps ratios. In particular, a post-trial systolic Pp/Ps ratio >0.5 correctly classified 100% of the PP-PAH and non-PAH patients. Trial occlusion is a feasible method to predict PP-PAH in patients with PDA and severe PAH. A post-trial systolic Pp/Ps ratio >0.5 indicates a high risk of PP-PAH occurrence after device closure. © 2014 American Heart Association, Inc.

Hydrotherapy as a recovery strategy after exercise: a pragmatic controlled trial.

Science.gov (United States)

Cuesta-Vargas, Antonio I; Travé-Mesa, Alvaro; Vera-Cabrera, Alberto; Cruz-Terrón, Dario; Castro-Sánchez, Adelaida M; Fernández-de-las-Peñas, Cesar; Arroyo-Morales, Manuel

2013-07-18

Our aim was to evaluate the recovery effects of hydrotherapy after aerobic exercise in cardiovascular, performance and perceived fatigue. A pragmatic controlled repeated measures; single-blind trial was conducted. Thirty-four recreational sportspeople visited a Sport-Centre and were assigned to a Hydrotherapy group (experimental) or rest in a bed (control) after completing a spinning session. Main outcomes measures including blood pressure, heart rate, handgrip strength, vertical jump, self-perceived fatigue, and body temperature were assessed at baseline, immediately post-exercise and post-recovery. The hypothesis of interest was the session*time interaction. The analysis revealed significant session*time interactions for diastolic blood pressure (P=0.031), heart rate (P=0.041), self perceived fatigue (P=0.046), and body temperature (P=0.001); but not for vertical jump (P=0.437), handgrip (P=0.845) or systolic blood pressure (P=0.266). Post-hoc analysis revealed that hydrotherapy resulted in recovered heart rate and diastolic blood pressure similar to baseline values after the spinning session. Further, hydrotherapy resulted in decreased self-perceived fatigue after the spinning session. Our results support that hydrotherapy is an adequate strategy to facilitate cardiovascular recovers and perceived fatigue, but not strength, after spinning exercise. ClinicalTrials.gov Identifier: NCT01765387.

Post-marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross-sectional study.

Science.gov (United States)

Zeitoun, Jean-David; Baron, Gabriel; Vivot, Alexandre; Atal, Ignacio; Downing, Nicholas S; Ross, Joseph S; Ravaud, Philippe

2018-01-15

Post-marketing research in oncology has rarely been described. We aimed to characterize post-marketing trials for a consistent set of anticancer agents over a long period. We performed a cross-sectional analysis of post-marketing trials registered at ClinicalTrials.gov through September 2014 for novel anticancer agents approved by both the US Food and Drug Administration and the European Medicines Agency between 2005 and 2010. All relevant post-marketing trials were classified according to indication, primary outcome, starting date, sponsors, and planned enrollment. Supplemental indications were retrieved from regulatory documents and publication rate was assessed by two different methods. Ten novel anticancer agents were eligible: five were indicated for hematologic malignancies and the remaining five for solid cancers (three for kidney cancer). We identified 2,345 post-marketing trials; 1,362 (58.1%) targeted an indication other than the originally approved one. We observed extreme variations among drugs in both number of post-marketing trials (range 8-530) and overall population to be enrolled per trial (1-8,381). Post-marketing trials assessed almost all types of cancers, the three most frequently studied cancers being leukemia, kidney cancer and myeloma. In all, 6.6% of post-marketing trials had a clinical endpoint as a primary outcome, and 35.9% and 54.1% had a safety or surrogate endpoint, respectively, as a primary outcome. Nine drugs obtained approval for supplemental indications. The publication rate at 10 years was 12.3 to 26.1% depending on the analysis method. In conclusion, we found that post-marketing research in oncology is highly heterogeneous and the publication rate of launched trials is low. © 2017 UICC.

Protocol for the effect evaluation of independent medical evaluation after six months sick leave: a randomized controlled trial of independent medical evaluation versus treatment as usual in Norway.

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Husabo, Elisabeth; Monstad, Karin; Holmås, Tor Helge; Oyeflaten, Irene; Werner, Erik L; Maeland, Silje

2017-06-14

It has been discussed whether the relationship between a patient on sick leave and his/her general practitioner (GP) is too close, as this may hinder the GP's objective evaluation of need for sick leave. Independent medical evaluation involves an independent physician consulting the patient. This could lead to new perspectives on sick leave and how to follow-up the patient. The current study is a randomized controlled trial in a Norwegian primary care context, involving an effect evaluation, a cost/benefit analysis, and a qualitative evaluation. Independent medical evaluation will be compared to treatment as usual, i.e., the physicians' and social insurance agencies' current management of long-term sick-listed patients. Individuals aged 18-65 years, sick listed by their GP and on full or partial sick leave for the past 6 months in Hordaland county will be included. Exclusion criteria are pregnancy, cancer, dementia or an ICD-10 diagnosis. A total sample of 3800 will be randomly assigned to either independent medical evaluation or treatment as usual. Official register data will be used to measure the primary outcome; change in sickness benefits at 7, 9 and 12 months. Sick listed in other counties will serve as a second control group, if appropriate under the "common trend" assumption. The Norwegian effect evaluation of independent medical evaluation after 6 months sick leave is a large randomized controlled trial, and the first of its kind, to evaluate this type of intervention as a means of getting people back to work after long-term sickness absence. ClinicalTrials.gov NCT02524392 . Registered June 23, 2015.

Home-based neurologic music therapy for arm hemiparesis following stroke: results from a pilot, feasibility randomized controlled trial.

Science.gov (United States)

Street, Alexander J; Magee, Wendy L; Bateman, Andrew; Parker, Michael; Odell-Miller, Helen; Fachner, Jorg

2018-01-01

To assess the feasibility of a randomized controlled trial to evaluate music therapy as a home-based intervention for arm hemiparesis in stroke. A pilot feasibility randomized controlled trial, with cross-over design. Randomization by statistician using computer-generated, random numbers concealed in opaque envelopes. Participants' homes across Cambridgeshire, UK. Eleven people with stroke and arm hemiparesis, 3-60 months post stroke, following discharge from community rehabilitation. Each participant engaged in therapeutic instrumental music performance in 12 individual clinical contacts, twice weekly for six weeks. Feasibility was estimated by recruitment from three community stroke teams over a 12-month period, attrition rates, completion of treatment and successful data collection. Structured interviews were conducted pre and post intervention to establish participant tolerance and preference. Action Research Arm Test and Nine-hole Peg Test data were collected at weeks 1, 6, 9, 15 and 18, pre and post intervention by a blinded assessor. A total of 11 of 14 invited participants were recruited (intervention n = 6, waitlist n = 5). In total, 10 completed treatment and data collection. It cannot be concluded whether a larger trial would be feasible due to unavailable data regarding a number of eligible patients screened. Adherence to treatment, retention and interview responses might suggest that the intervention was motivating for participants. ClinicalTrials.gov identifier NCT 02310438.

The theory-based policy evaluation method applied to the ex-post evaluation of climate change policies in the built environment in the Netherlands

International Nuclear Information System (INIS)

Harmelink, Mirjam; Joosen, Suzanne; Blok, Kornelis

2005-01-01

The challenge within ex-post policy evaluation research is to unravel the whole policy process and evaluate the effect and effectiveness of the different steps. Through this unravelling of the policy implementation process, insight is gained on where something went wrong in the process of policy design and implementation and where the keys are for improving the effectiveness and efficiency. This article presents the results of an ex-post policy evaluation of the effect and effectiveness of the Energy Premium Regulation scheme and the Long Term Voluntary agreements to reduce CO 2 emissions in the built environment in the Netherlands applying the theory-based policy evaluation method. The article starts with a description of the theory-based policy evaluation method. The method begins with the formulation of a program theory, which describes the 'ideal' operation of a policy instrument, from the viewpoint of the policy makers. Thereupon the theory is checked and adapted through interviews with policy makers and executors, and the cause and effect chain is finally translated to (quantitative) indicators. The article shows that the theory-based evaluation method has benefits over other ex-post evaluation methods that include: The whole policy implementation process is evaluated and the focus is not just on the 'end-result' (i.e. efficiency improvement and CO 2 emission reduction). Through the development of indicators for each step in the implementation process, 'successes and failures' are quantified to the greatest possible extent. By applying this approach we not only learn whether policies are successful or not, but also why they succeeded or failed and how they can be improved

Effects of Whey Protein Supplementation Pre- or Post-Resistance Training on Muscle Mass, Muscular Strength, and Functional Capacity in Pre-Conditioned Older Women: A Randomized Clinical Trial

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Hellen C. G. Nabuco

2018-05-01

Full Text Available Aging is associated with sarcopenia and dynapenia, with both processes contributing to functional dependence and mortality in older adults. Resistance training (RT and increased protein intake are strategies that may contribute to health improvements in older adults. Therefore, the aim was to investigate the effects of whey protein (WP supplementation consumed either immediately pre- or post-RT on skeletal muscle mass (SMM, muscular strength, and functional capacity in pre-conditioned older women. Seventy older women participated in this investigation and were randomly assigned to one of three groups: whey protein pre-RT and placebo post-RT (WP-PLA, n = 24, placebo pre-RT and whey protein post-RT (PLA-WP, n = 23, and placebo pre- and post-RT (PLA-PLA, n = 23. Each group ingested 35 g of WP or PLA. The RT program was carried out over 12 weeks (three times per week; 3 × 8–12 repetition maximum. Body composition, muscular strength, functional capacity, and dietary intake were assessed pre- and post-intervention. Two-way analysis of covariance (ANCOVA for repeated measures, with baseline scores as covariates were used for data analysis. A time vs. group interaction (p < 0.05 was observed with WP-PLA and PLA-WP presenting greater increases compared with PLA-PLA for SMM (WP-PLA = 3.4%; PLA-WP = 4.2%; PLA-PLA = 2.0%, strength (WP-PLA = 8.1%; PLA-WP = 8.3%; PLA-PLA = 7.0%, and the 10-m walk test (WP-PLA = −10.8%; PLA-WP = −11.8%; PLA-PLA = −4.3%. Whey protein supplementation was effective in promoting increases in SMM, muscular strength, and functional capacity in pre-conditioned older women, regardless of supplementation timing. This trial was registered at ClinicalTrials.gov: NCT03247192.

A Cluster-Randomized Trial of Restorative Practices: An Illustration to Spur High-Quality Research and Evaluation

Science.gov (United States)

Acosta, Joie D.; Chinman, Matthew; Ebener, Patricia; Phillips, Andrea; Xenakis, Lea; Malone, Patrick S.

2016-01-01

Restorative practices in schools lack rigorous evaluation studies. As an example of rigorous school-based research, this article describes the first randomized control trial of restorative practices to date, the Study of Restorative Practices. It is a 5-year, cluster-randomized controlled trial (RCT) of the Restorative Practices Intervention (RPI)…

Lenient vs. strict rate control in patients with atrial fibrillation and heart failure: a post-hoc analysis of the RACE II study

NARCIS (Netherlands)

Mulder, Bart A.; van Veldhuisen, Dirk J.; Crijns, Harry J. G. M.; Tijssen, Jan G. P.; Hillege, Hans L.; Alings, Marco; Rienstra, Michiel; Groenveld, Hessel F.; van den Berg, Maarten P.; van Gelder, Isabelle C.

2013-01-01

It is unknown whether lenient rate control is an acceptable strategy in patients with AF and heart failure. We evaluated differences in outcome in patients with AF and heart failure treated with lenient or strict rate control. This post-hoc analysis of the RACE II trial included patients with an

A prospective, randomized, double-blind, placebo-controlled parallel-group dual site trial to evaluate the effects of a Bacillus coagulans-based product on functional intestinal gas symptoms

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Feldman Samantha

2009-11-01

Full Text Available Abstract Background This randomized double blind placebo controlled dual site clinical trial compared a probiotic dietary supplement to placebo regarding effects on gastrointestinal symptoms in adults with post-prandial intestinal gas-related symptoms (abdominal pain, distention, flatulence but no gastrointestinal (GI diagnoses to explain the symptoms. Methods Sixty-one adults were enrolled (age 36.5 ± 12.6 years; height 165.1 ± 9.2 cm; weight 75.4 ± 17.3 kg and randomized to either Digestive Advantage™ Gas Defense Formula - (GanedenBC30 Bacillus coagulans GBI-30, 6086: n = 30; or Placebo: n = 31. Study subjects were evaluated every two weeks over a four-week period using validated questionnaires and standard biochemical safety testing. Outcome criteria of interest included change from baseline in Gastrointestinal Symptom Rating Scale (GSRS abdominal pain, abdominal distention, flatus, and the Severity of Dyspepsia Assessment (SODA bloating and gas subscores over four weeks of product use. Results Measured against the placebo, subjects in the probiotic group achieved significant improvements in GSRS abdominal pain subscore (p = 0.046 and the GSRS total score (p = 0.048, with a strong trend for improvement on the GSRS abdominal distension subscore (p = 0.061. A strong placebo effect was evident which could explain the lack of statistical significant differences between the groups for many of the efficacy variables. Conclusion In conclusion, the Bacillus coagulans-based product was effective in improving the quality of life and reducing gastrointestinal symptoms in adults with post prandial intestinal gas-related symptoms and no GI diagnoses. Trial Registration ClinicalTrials.gov Identifier: NCT00881322

[Expert consensus post-marketing evaluation scheme to detect immunotoxicity of Chinese medicine in clinical populations (draft version for comments)].

Science.gov (United States)

Xie, Yan-Ming; Zhao, Yu-Bin; Jiang, Jun-Jie; Chang, Yan-Peng; Zhang, Wen; Shen, Hao; Lu, Peng-Fei

2013-09-01

Through consensus, establish a post-marketing scheme and the technical processes to evaluate Chinese medicine's immunotoxicity on a population, as well as its beneficial influences on the immune system. Provide regulations on the collection, storage and transportation of serum samples. This article applies to the post-marketing scientific evaluation of the immunotoxicity of parenterally administered, and for other ways of taking Chinese medicine.

A Randomised, Double-Blind, Placebo-Controlled Trial of Actovegin in Patients with Post-Stroke Cognitive Impairment: ARTEMIDA Study Design

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Alla Guekht

2013-12-01

Full Text Available Background: No drug treatment to date has shown convincing clinical evidence of restoring cognitive function or preventing further decline after stroke. The ongoing ARTEMIDA study will evaluate the efficacy and safety of Actovegin for the symptomatic treatment of post-stroke cognitive impairment (PSCI and will explore whether Actovegin has any disease-modifying effect by assessing whether any changes are sustained after treatment. Design: ARTEMIDA is a 12-month, multicentre trial in patients (planned a total of 500, now recruited with cognitive impairment following ischaemic stroke. The study consists of a baseline screening (≤7 days after stroke, after which eligible patients are randomised to Actovegin (2,000 mg/day for up to 20 intravenous infusions followed by 1,200 mg/day orally or placebo for a 6-month double-blind treatment period. Patients will be followed up for a further 6 months, during which time they will be treated in accordance with standard clinical practice. The primary study endpoint is change from baseline in the Alzheimer's Disease Assessment Scale, cognitive subscale, extended version. Secondary outcomes include: Montreal Cognitive Assessment; dementia diagnosis (ICD-10; National Institutes of Health Stroke Scale; Barthel Index; EQ-5D; Beck Depression Inventory, version II, and safety. Conclusion: There is a clear need for effective treatments for PSCI. ARTEMIDA should provide important insights into the use of a novel drug therapy for PSCI.

Feasibility and Efficacy of an mHealth Game for Managing Anxiety: "Flowy" Randomized Controlled Pilot Trial and Design Evaluation.

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Pham, Quynh; Khatib, Yasmin; Stansfeld, Stephen; Fox, Simon; Green, Tobias

2016-02-01

Meeting the complex needs of patients with chronic common mental health disorders (CMHDs) may be the greatest challenge facing organized medical practice. On the basis of a well-established and proven theoretical foundation for controlled respiration as a behavioral intervention for CMHDs, as well as preliminary evidence that gamification can improve health outcomes through increasing patient engagement, this randomized controlled pilot study evaluated the feasibility and clinical efficacy of a mobile health game called "Flowy" ( www.flowygame.com ) that digitally delivered breathing retraining exercises for anxiety, panic, and hyperventilation symptom management. We designed an unblinded, Web-based, parallel-group randomized controlled trial focusing on feasibility, clinical efficacy, and design proof of concept. In the intervention condition (n = 31), participants received free access to "Flowy" for 4 weeks. In the control condition (n = 32), participants were placed on a waitlist for 4 weeks before being offered free access to "Flowy." Online measurements using psychological self-report questionnaires were made at 2 and 4 weeks post-baseline. At trial conclusion, participants found "Flowy" acceptable as an anxiety management intervention. "Flowy" engaged participants sufficiently to endorse proactive gameplay. Intent-to-treat analysis revealed a reduction in anxiety, panic, and self-report hyperventilation scores in both trial arms, with the intervention arm experiencing greater quality of life. Participants perceived "Flowy" as a fun and useful intervention, proactively used "Flowy" as part of their care, and would recommend "Flowy" to family and friends. Our results suggest that a digital delivery of breathing retraining exercises through a mobile health game can manage anxiety, panic, and hyperventilation symptoms associated with CMHDs.

Cost-effectiveness of cryotherapy versus salicylic acid for the treatment of plantar warts: economic evaluation alongside a randomised controlled trial (EVerT trial

Directory of Open Access Journals (Sweden)

Stamuli Eugena

2012-02-01

Full Text Available Abstract Background Plantar warts (verrucae are extremely common. Although many will spontaneously disappear without treatment, treatment may be sought for a variety of reasons such as discomfort. There are a number of different treatments for cutaneous warts, with salicylic acid and cryotherapy using liquid nitrogen being two of the most common forms of treatment. To date, no full economic evaluation of either salicylic acid or cryotherapy has been conducted based on the use of primary data in a pragmatic setting. This paper describes the cost-effectiveness analysis which was conducted alongside a pragmatic multicentre, randomised trial evaluating the clinical effectiveness of cryotherapy versus 50% salicylic acid of the treatment of plantar warts. Methods A cost-effectiveness analysis was undertaken alongside a pragmatic multicentre, randomised controlled trial assessing the clinical effectiveness of 50% salicylic acid and cryotherapy using liquid nitrogen at 12 weeks after randomisation of patients. Cost-effectiveness outcomes were expressed as the additional cost required to completely cure the plantar warts of one additional patient. A NHS perspective was taken for the analysis. Results Cryotherapy costs on average £101.17 (bias corrected and accelerated (BCA 95% CI: 85.09-117.26 more per participant over the 12 week time-frame, while there is no additional benefit, in terms of proportion of patients healed compared with salicylic acid. Conclusions Cryotherapy is more costly and no more effective than salicylic acid. Trial registration Current Controlled Trials ISRCTN18994246 [controlled-trials.com] and National Research Register N0484189151.

Cost-effectiveness of cryotherapy versus salicylic acid for the treatment of plantar warts: economic evaluation alongside a randomised controlled trial (EVerT trial)

Science.gov (United States)

2012-01-01

Abstract Background Plantar warts (verrucae) are extremely common. Although many will spontaneously disappear without treatment, treatment may be sought for a variety of reasons such as discomfort. There are a number of different treatments for cutaneous warts, with salicylic acid and cryotherapy using liquid nitrogen being two of the most common forms of treatment. To date, no full economic evaluation of either salicylic acid or cryotherapy has been conducted based on the use of primary data in a pragmatic setting. This paper describes the cost-effectiveness analysis which was conducted alongside a pragmatic multicentre, randomised trial evaluating the clinical effectiveness of cryotherapy versus 50% salicylic acid of the treatment of plantar warts. Methods A cost-effectiveness analysis was undertaken alongside a pragmatic multicentre, randomised controlled trial assessing the clinical effectiveness of 50% salicylic acid and cryotherapy using liquid nitrogen at 12 weeks after randomisation of patients. Cost-effectiveness outcomes were expressed as the additional cost required to completely cure the plantar warts of one additional patient. A NHS perspective was taken for the analysis. Results Cryotherapy costs on average £101.17 (bias corrected and accelerated (BCA) 95% CI: 85.09-117.26) more per participant over the 12 week time-frame, while there is no additional benefit, in terms of proportion of patients healed compared with salicylic acid. Conclusions Cryotherapy is more costly and no more effective than salicylic acid. Trial registration Current Controlled Trials ISRCTN18994246 [controlled-trials.com] and National Research Register N0484189151. PMID:22369511

Evaluation of the effects of an offer of a monetary incentive on the rate of questionnaire return during follow-up of a clinical trial: a randomised study within a trial.

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Hardy, Pollyanna; Bell, Jennifer L; Brocklehurst, Peter

2016-07-15

A systematic review on the use of incentives to promote questionnaire return in clinical trials suggest they are effective, but not all studies have sufficient funds to use them. Promising an incentive once data are returned can reduce the cost-burden of this approach, with possible further cost-savings if the offer were restricted to reminder letters only. This study aimed to evaluate the effect of promising a monetary incentive at first mailout versus a promise on reminder letters only. This was a randomised Study Within A Trial (SWAT) nested within BUMPES, a multicentre randomised controlled trial of maternal position in the late stage of labour in women with an epidural. The follow-up questionnaire asked for information on the women's health, wellbeing and health service use one year following the birth of their baby. Women who consented to be contacted were randomised to a promise of a monetary incentive at first mailout or a promise on reminder letters only. Women were given an option of completing the questionnaire on paper or on online. The incentive was posted out on receipt of a completed questionnaire. The primary outcome was the overall return rate, and secondary outcomes were the return rate without any chasing from the study office, and the total cost of the vouchers. A total of 1,029 women were randomised, 508 to the first mailout group and 518 to the reminder group. There was no evidence to suggest a difference between groups in the overall return rate (adjusted RR 1.03 (95 % CI 0.96 to 1.11), however the proportion returned without chasing was higher in the first mailout group (adjusted RR 1.22, 95 % CI 1.07 to 1.39). The total cost of the vouchers per participant was higher in the first mailout group (mean difference £4.56, 95 % CI £4.02 to £5.11). Offering a monetary incentive when a reminder is required could be cost-effective depending on the sample size of the study and the resources available to administer the reminder letters. The

Pre- and Post-Trial Equality in Criminal Justice in the Context of the Separation of Powers

Directory of Open Access Journals (Sweden)

L Wolf

2011-08-01

Full Text Available The previous Westminster criminal justice system entailed a different kind of separation of powers insofar as it concerns the role of state prosecutors. In the Westminster system prosecutors are part of the executive branch, whereas they were a split-off from the judiciary in constitutional states and function like a de facto second organ of the third branch of state power. Currently executive interference in state prosecutions often leads to pre-trial inequality. A further difficulty arises from the unconsidered manner in which the former royal prerogative of pardoning was retained in the Constitution of the Republic of South Africa, 1996. It used to be a royal veto of judicial sentences in the constitutional monarchy of the former Westminster model. Although the corresponding veto of parliamentary legislation by the head of state did not survive into modern times, the pardoning power has not been discontinued. Section 84(2(j thus causes an irreconcilable conflict with section 165(5 of the Constitution which guarantees the legally binding force of judicial decisions. It undermines the rule of law and leads to post-trial inequality in the execution of sentences. The parole system, which dates back to 1959, likewise allows the executive to overrule judicial sentences and is in conflict with section 165(5. The perpetuation of the status quo in criminal justice is in effect leading to a re-Westminstering of the constitutional state.

Study and treatment of post Lyme disease (STOP-LD): a randomized double masked clinical trial.

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Krupp, L B; Hyman, L G; Grimson, R; Coyle, P K; Melville, P; Ahnn, S; Dattwyler, R; Chandler, B

2003-06-24

To determine whether post Lyme syndrome (PLS) is antibiotic responsive. The authors conducted a single-center randomized double-masked placebo-controlled trial on 55 patients with Lyme disease with persistent severe fatigue at least 6 or more months after antibiotic therapy. Patients were randomly assigned to receive 28 days of IV ceftriaxone or placebo. The primary clinical outcomes were improvement in fatigue, defined by a change of 0.7 points or more on an 11-item fatigue questionnaire, and improvement in cognitive function (mental speed), defined by a change of 25% or more on a test of reaction time. The primary laboratory outcome was an experimental measure of CSF infection, outer surface protein A (OspA). Outcome data were collected at the 6-month visit. Patients assigned to ceftriaxone showed improvement in disabling fatigue compared to the placebo group (rate ratio, 3.5; 95% CI, 1.50 to 8.03; p = 0.001). No beneficial treatment effect was observed for cognitive function or the laboratory measure of persistent infection. Four patients, three of whom were on placebo, had adverse events associated with treatment, which required hospitalization. Ceftriaxone therapy in patients with PLS with severe fatigue was associated with an improvement in fatigue but not with cognitive function or an experimental laboratory measure of infection in this study. Because fatigue (a nonspecific symptom) was the only outcome that improved and because treatment was associated with adverse events, this study does not support the use of additional antibiotic therapy with parenteral ceftriaxone in post-treatment, persistently fatigued patients with PLS.

Ahmed glaucoma valve in post-penetrating-keratoplasty glaucoma: A critically evaluated prospective clinical study

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Panda, Anita; Prakash, Vadivelu Jaya; Dada, Tanuj; Gupta, Anoop Kishore; Khokhar, Sudarshan; Vanathi, Murugesan

2011-01-01

Aim: The aim was to evaluate the outcome of Ahmed glaucoma valve (AGV) in post-penetrating-keratoplasty glaucoma (PKPG). Materials and Methods: In this prospective study, 20 eyes of 20 adult patients with post-PKPG with intraocular pressure (IOP) >21 mmHg, on two or more antiglaucoma medications, underwent AG (model FP7) implantation and were followed up for a minimum of 6 months. Absolute success was defined as 5 glaucoma managed by AGV implantation revealed a satisfactory outcome up to 6 months of follow-up. PMID:21586837

Penile vibratory stimulation in the treatment of post-prostatectomy incontinence

DEFF Research Database (Denmark)

Fode, Mikkel; Sønksen, Jens

2015-01-01

AIMS: To examine penile vibratory stimulation (PVS) in the treatment of post-prostatectomy urinary incontinence (UI). METHODS: Patients with post-prostatectomy UI were included in a 12-week trial. A 24-hr pad test and a 72-hr voiding diary were collected at baseline. Participants were randomized ...

Post-mortem CT evaluation of atlanto-occipital dissociation.

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Madadin, Mohammed; Samaranayake, Ravindra Priyalal; O'Donnell, Chris; Cordner, Stephen

2017-02-01

Atlanto-occipital dissociation injury is an important injury in forensic pathology practice. Radiological diagnosis of atlanto-occipital dissociation clinically is assessed by direct measurement of occipito-vertebral skeletal relationships. Different measurements may be used to diagnose atlanto-occipital dissociation, including the basion-dens interval (BDI) and basion-axial interval (BAI). It is not known whether the normal ante-mortem measurements of BDI and BAI described in the literature are applicable to post-mortem CT images of the occipito-cervical junction (OCJ) or whether these measurements could be affected by early post-mortem changes. This study aims to compare post-mortem BDI and BAI measurements with ante-mortem values. Post-mortem CT scans of the cervical spines of 100 deceased adults were reviewed, and the BDI and BAI were measured. Different parameters were recorded in each case. The results from this study suggest that there are no effects of post-mortem changes on the measurement of BAI as relied upon clinically. There appear to be some effects of fully established rigor mortis on BDI measurement, shortening it. This may have consequences for the post mortem diagnosis of atlanto-occipital dissociation. Copyright © 2016 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.

Study on post-earthquake plant evaluation and communication (Annual safety research report, JFY 2011)

International Nuclear Information System (INIS)

2012-01-01

The aims of this study are to establish a post-earthquake plant evaluation method and to develop a communication system for the improving seismic safety regulations as well as encouraging public communication. The Miyagiken-oki earthquake in 2005, Onagawa Nuclear Power Plant shut down automatically. Subsequently, JNES started development of post-earthquake plant evaluation and communication system based on the experience of the cross-check analysis for Onagawa Nuclear Power Plant. The Niigata-ken Chuetsu-oki Earthquake in 2007, the plant situation was not transmitted promptly. The loss of information sharing between local community and related organizations caused the public anxiety. The importance of plant information transmission as well as seismic information gathering were recognized. The proposal for the solution of the information issues were performed by government committee, In this study the evaluation method for soundness of the main structure and equipment after earthquake event were updated. Moreover, information dissemination to the public and transparent communication methodology was examined by the Industry-Academia-Government cooperation in the Kashiwazaki-Kariwa region. (author)

Recent advances in post autologous transplantation maintenance therapies in B-cell non-Hodgkin lymphomas

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Epperla, Narendranath; Fenske, Timothy S; Hari, Parameswaran N; Hamadani, Mehdi

2015-01-01

Lymphomas constitute the second most common indication for high dose therapy (HDT) followed by autologous hematopoietic cell transplantation (auto-HCT). The intent of administering HDT in these heterogeneous disorders varies from cure (e.g., in relapsed aggressive lymphomas) to disease control (e.g., most indolent lymphomas). Regardless of the underlying histology or remission status at transplantation, disease relapse remains the number one cause of post auto-HCT therapy failure and mortality. The last decade has seen a proliferation of clinical studies looking at prevention of post auto-HCT therapy failure with various maintenance strategies. The benefit of such therapies is in turn dependent on disease histology and timing of transplantation. In relapsed, chemosensitive diffuse large B-cell lymphoma (DLBCL), although post auto-HCT maintenance rituximab seems to be safe and feasible, it does not provide improved survival outcomes and is not recommended. The preliminary results with anti- programmed death -1 (PD-1) antibody therapy as post auto-HCT maintenance in DLBCL is promising but requires randomized validation. Similarly in follicular lymphoma, maintenance therapies including rituximab following auto-HCT should be considered investigational and offered only on a clinical trial. Rituximab maintenance results in improved progression-free survival but has not yet shown to improve overall survival in mantle cell lymphoma (MCL), but given the poor prognosis with post auto-HCT failure in MCL, maintenance rituximab can be considered on a case-by-case basis. Ongoing trials evaluating the efficacy of post auto-HCT maintenance with novel compounds (e.g., immunomodulators, PD-1 inhibitors, proteasome inhibitors and bruton’s tyrosine kinase inhibitors) will likely change the practice landscape in the near future for B cell non-Hodgkin lymphomas patients following HDT and auto-HCT. PMID:26421260

Using data envelopment analysis to evaluate the performance of post-hurricane electric power restoration activities

International Nuclear Information System (INIS)

Reilly, Allison C.; Davidson, Rachel A.; Nozick, Linda K.; Chen, Thomas; Guikema, Seth D.

2016-01-01

Post-hurricane restoration of electric power is attracting increasing scrutiny as customers’ tolerance for even short power interruptions decreases. At the peak, 8.5 million customers were without power after Hurricane Sandy and over 1 million customers were without power more than a week after the storm made landfall. Currently, restoration processes are typically evaluated on a case-by-case basis by a regional public service commission or similar body and lack systematic comparisons to other restoration experiences. This paper introduces a framework using data envelopment analysis to help evaluate post-hurricane restorations through comparison with the experiences of other companies in similar storms. The method accounts for the variable severity of the hurricanes themselves, so that companies are not penalized for outages that are long only because the hurricane that caused them was particularly severe. The analysis is illustrated through an application comparing 27 recent post-hurricane restoration experiences across 13 different electric power companies in the United States. The results of the study show some consistency in performance among individual utilities after the hurricanes they experience. The method could be applied to other types of infrastructure systems and other extreme events as well. - Highlights: • A Data Envelopment Analysis (DEA) framework is developed to compare post- hurricane power-outage restoration performance. • Hurricane severity is considered, so that utilities are not penalized for long outages caused by severe storms. • A case study using real data compares 27 recent post-hurricane restoration experiences. • The results of the study show utilities tend to perform consistently after the hurricanes they experience.

Effectiveness and economic evaluation of self-help educational materials for the prevention of smoking relapse: randomised controlled trial.

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Blyth, Annie; Maskrey, Vivienne; Notley, Caitlin; Barton, Garry R; Brown, Tracey J; Aveyard, Paul; Holland, Richard; Bachmann, Max O; Sutton, Stephen; Leonardi-Bee, Jo; Brandon, Thomas H; Song, Fujian

2015-07-01

Most people who quit smoking successfully for a short period will return to smoking again in 12 months. A previous exploratory meta-analysis indicated that self-help booklets may be effective for smoking relapse prevention in unaided quitters. This study aimed to evaluate the effectiveness of a set of self-help educational booklets to prevent smoking relapse in people who had stopped smoking with the aid of behavioural support. This is an open, randomised controlled trial and qualitative process evaluation. Trial participants were randomly allocated to one of two groups, using a simple randomisation process without attempts to stratify by participant characteristics. The participant allocation was 'concealed' because the recruitment of quitters occurred before the random allocation. Short-term quitters were recruited from NHS Stop Smoking Clinics, and self-help educational materials were posted to study participants at home. A total of 1407 carbon monoxide (CO)-validated quitters at 4 weeks after quit date in NHS Stop Smoking Clinics. The trial excluded pregnant women and quitters who were not able to read the educational materials in English. Participants in the experimental group (n = 703) received a set of eight revised Forever Free booklets, and participants in the control group (n = 704) received a single leaflet that is currently given to NHS patients. Follow-up telephone interviews were conducted 3 and 12 months after quit date. The primary outcome was prolonged, CO-verified abstinence from months 4 to 12 during which time no more than five cigarettes were smoked. The secondary outcomes included self-reported abstinence during the previous 7 days at 3 and 12 months, CO-verified abstinence at 12 months, costs (NHS and NHS and participant medication costs perspectives) and quality-adjusted life-years. Logistic regression analyses were conducted to investigate effect-modifying variables. A simultaneous qualitative process evaluation was conducted to help

Impact on learning of an e-learning module on leukaemia: a randomised controlled trial.

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Morgulis, Yuri; Kumar, Rakesh K; Lindeman, Robert; Velan, Gary M

2012-05-28

e-learning resources may be beneficial for complex or conceptually difficult topics. Leukaemia is one such topic, yet there are no reports on the efficacy of e-learning for leukaemia. This study compared the learning impact on senior medical students of a purpose-built e-learning module on leukaemia, compared with existing online resources. A randomised controlled trial was performed utilising volunteer senior medical students. Participants were randomly allocated to Study and Control groups. Following a pre-test on leukaemia administered to both groups, the Study group was provided with access to the new e-learning module, while the Control group was directed to existing online resources. A post-test and an evaluation questionnaire were administered to both groups at the end of the trial period. Study and Control groups were equivalent in gender distribution, mean academic ability, pre-test performance and time studying leukaemia during the trial. The Study group performed significantly better than the Control group in the post-test, in which the group to which the students had been allocated was the only significant predictor of performance. The Study group's evaluation of the module was overwhelmingly positive. A targeted e-learning module on leukaemia had a significant effect on learning in this cohort, compared with existing online resources. We believe that the interactivity, dialogic feedback and integration with the curriculum offered by the e-learning module contributed to its impact. This has implications for e-learning design in medicine and other disciplines.

A cluster randomised controlled effectiveness trial evaluating perinatal home visiting among South African mothers/infants.

Directory of Open Access Journals (Sweden)

Mary Jane Rotheram-Borus

Full Text Available Interventions are needed to reduce poor perinatal health. We trained community health workers (CHWs as home visitors to address maternal/infant risks.In a cluster randomised controlled trial in Cape Town townships, neighbourhoods were randomised within matched pairs to 1 the control, healthcare at clinics (n = 12 neighbourhoods; n = 594 women, or 2 a home visiting intervention by CBW trained in cognitive-behavioural strategies to address health risks (by the Philani Maternal, Child Health and Nutrition Programme, in addition to clinic care (n = 12 neighbourhoods; n = 644 women. Participants were assessed during pregnancy (2% refusal and 92% were reassessed at two weeks post-birth, 88% at six months and 84% at 18 months later. We analysed 32 measures of maternal/infant well-being over the 18 month follow-up period using longitudinal random effects regressions. A binomial test for correlated outcomes evaluated overall effectiveness over time. The 18 month post-birth assessment outcomes also were examined alone and as a function of the number of home visits received.Benefits were found on 7 of 32 measures of outcomes, resulting in significant overall benefits for the intervention compared to the control when using the binomial test (p = 0.008; nevertheless, no effects were observed when only the 18 month outcomes were analyzed. Benefits on individual outcomes were related to the number of home visits received. Among women living with HIV, intervention mothers were more likely to implement the PMTCT regimens, use condoms during all sexual episodes (OR = 1.25; p = 0.014, have infants with healthy weight-for-age measurements (OR = 1.42; p = 0.045, height-for-age measurements (OR = 1.13, p<0.001, breastfeed exclusively for six months (OR = 3.59; p<0.001, and breastfeed longer (OR = 3.08; p<0.001. Number of visits was positively associated with infant birth weight ≥2500 grams (OR = 1.07; p = 0

Aging, obesity, and post-therapy cognitive recovery in breast cancer survivors.

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Huang, Zhezhou; Zheng, Ying; Bao, Pingping; Cai, Hui; Hong, Zhen; Ding, Ding; Jackson, James; Shu, Xiao-Ou; Dai, Qi

2017-02-14

Therapy-induced cognitive impairment is prevalent and long-lasting in cancer survivors, but factors affecting post-therapy cognitive recovery are unclear. We conducted this study to evaluate the associations of age, body mass index (BMI), waist-to-hip ratio (WHR), and physical activity (PA) with post-therapy cognitive changes in a population-based breast cancer (BC) survivor cohort. We collected information on PA, weight, height, waist and hip circumferences of 1286 BC survivors aged 20-75. We assessed their cognitive functions, including immediate memory, delayed memory, verbal fluency, and attention, at 18 and 36 months after cancer diagnosis. Linear regression models were used to examine the associations of age, BMI, WHR and PA with mean changes in cognitive scores from 18- to 36-month follow-up interview. We found that the post-therapy cognitive changes differed by age and obesity status. Verbal fluency and attention improved in younger patients aged therapy cognitive change. Due to the novelty of our findings and the limitations of our study, further research, including intervention trials, is warranted to confirm the causal relationship between obesity and cognitive impairments.

Application of balanced scorecard in the evaluation of a complex health system intervention: 12 months post intervention findings from the BHOMA intervention: a cluster randomised trial in Zambia.

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Mutale, Wilbroad; Stringer, Jeffrey; Chintu, Namwinga; Chilengi, Roma; Mwanamwenge, Margaret Tembo; Kasese, Nkatya; Balabanova, Dina; Spicer, Neil; Lewis, James; Ayles, Helen

2014-01-01

In many low income countries, the delivery of quality health services is hampered by health system-wide barriers which are often interlinked, however empirical evidence on how to assess the level and scope of these barriers is scarce. A balanced scorecard is a tool that allows for wider analysis of domains that are deemed important in achieving the overall vision of the health system. We present the quantitative results of the 12 months follow-up study applying the balanced scorecard approach in the BHOMA intervention with the aim of demonstrating the utility of the balanced scorecard in evaluating multiple building blocks in a trial setting. The BHOMA is a cluster randomised trial that aims to strengthen the health system in three rural districts in Zambia. The intervention aims to improve clinical care quality by implementing practical tools that establish clear clinical care standards through intensive clinic implementations. This paper reports the findings of the follow-up health facility survey that was conducted after 12 months of intervention implementation. Comparisons were made between those facilities in the intervention and control sites. STATA version 12 was used for analysis. The study found significant mean differences between intervention(I) and control (C) sites in the following domains: Training domain (Mean I:C; 87.5.vs 61.1, mean difference 23.3, p = 0.031), adult clinical observation domain (mean I:C; 73.3 vs.58.0, mean difference 10.9, p = 0.02 ) and health information domain (mean I:C; 63.6 vs.56.1, mean difference 6.8, p = 0.01. There was no gender differences in adult service satisfaction. Governance and motivation scores did not differ between control and intervention sites. This study demonstrates the utility of the balanced scorecard in assessing multiple elements of the health system. Using system wide approaches and triangulating data collection methods seems to be key to successful evaluation of such complex health

Post retention and post/core shear bond strength of four post systems.

Science.gov (United States)

Stockton, L W; Williams, P T; Clarke, C T

2000-01-01

As clinicians we continue to search for a post system which will give us maximum retention while maximizing resistance to root fracture. The introduction of several new post systems, with claims of high retentive and resistance to root fracture values, require that independent studies be performed to evaluate these claims. This study tested the tensile and shear dislodgment forces of four post designs that were luted into roots 10 mm apical of the CEJ. The Para Post Plus (P1) is a parallel-sided, passive design; the Para Post XT (P2) is a combination active/passive design; the Flexi-Post (F1) and the Flexi-Flange (F2) are active post designs. All systems tested were stainless steel. This study compared the test results of the four post designs for tensile and shear dislodgment. All mounted samples were loaded in tension until failure occurred. The tensile load was applied parallel to the long axis of the root, while the shear load was applied at 450 to the long axis of the root. The Flexi-Post (F1) was significantly different from the other three in the tensile test, however, the Para Post XT (P2) was significantly different to the other three in the shear test and had a better probability for survival in the Kaplan-Meier survival function test. Based on the results of this study, our recommendation is for the Para Post XT (P2).

Psychological interventions for post-traumatic stress disorder in people living with HIV in Resource poor settings: a systematic review.

Science.gov (United States)

Verhey, Ruth; Chibanda, Dixon; Brakarsh, Jonathan; Seedat, Soraya

2016-10-01

Post-traumatic stress disorder is pervasive in low- and middle-income countries. There is evidence to suggest that post-traumatic stress disorder is more common among people living with HIV than non-infected matched controls. We carried out a systematic review of interventions for adult post-traumatic stress disorder from resource poor settings with a focus on people living with HIV. We included all studies that investigated interventions for adult post-traumatic stress disorder from resource poor settings with a focus on interventions that were either randomised controlled trials or observational cohort studies carried out from 1980 to May 2015. Of the 25 articles that were identified for full review, two independent reviewers identified seven studies that met our study inclusion criteria. All randomised controlled trials (RCT) (n = 6) used cognitive behavioural therapy-based interventions and focused on people living with HIV in resource poor settings. There was only one study focusing on the use of lay counsellors to address post-traumatic stress disorder but core competencies were not described. There were no intervention studies from Africa, only an observational cohort study from Rwanda. Rigorously evaluated interventions for adult post-traumatic stress disorder in people living with HIV are rare. Most were undertaken in resource poor settings located in high-income countries. There is a need for research on the development and implementation of appropriate interventions for post-traumatic stress disorder in people living with HIV in low- and middle-income countries. © 2016 John Wiley & Sons Ltd.

Evaluation of a training program of hypertension for accredited social health activists (ASHA) in rural India.

Science.gov (United States)

Abdel-All, Marwa; Thrift, Amanda Gay; Riddell, Michaela; Thankappan, Kavumpurathu Raman Thankappan; Mini, Gomathyamma Krishnakurup; Chow, Clara K; Maulik, Pallab Kumar; Mahal, Ajay; Guggilla, Rama; Kalyanram, Kartik; Kartik, Kamakshi; Suresh, Oduru; Evans, Roger George; Oldenburg, Brian; Thomas, Nihal; Joshi, Rohina

2018-05-02

Hypertension is a major risk factor for cardiovascular disease, a leading cause of premature death and disability in India. Since access to health services is poor in rural India and Accredited Social Health Activists (ASHAs) are available throughout India for maternal and child health, a potential solution for improving hypertension control is by utilising this available workforce. We aimed to develop and implement a training package for ASHAs to identify and control hypertension in the community, and evaluate the effectiveness of the training program using the Kirkpatrick Evaluation Model. The training program was part of a cluster randomised feasibility trial of a 3-month intervention to improve hypertension outcomes in South India. Training materials incorporated details on managing hypertension, goal setting, facilitating group meetings, and how to measure blood pressure and weight. The 15 ASHAs attended a five-day training workshop that was delivered using interactive instructional strategies. ASHAs then led community-based education support groups for 3 months. Training was evaluated using Kirkpatrick's evaluation model for measuring reactions, learning, behaviour and results using tests on knowledge at baseline, post-training and post-intervention, observation of performance during meetings and post-intervention interviews. The ASHAs' knowledge of hypertension improved from a mean score of 64% at baseline to 76% post-training and 84% after the 3-month intervention. Research officers, who observed the community meetings, reported that ASHAs delivered the self-management content effectively without additional assistance. The ASHAs reported that the training materials were easy to understand and useful in educating community members. ASHAs can be trained to lead community-based group educational discussions and support individuals for the management of high blood pressure. The feasibility trial is registered with the Clinical Trials Registry - India (CTRI

Clinical and cost effectiveness of computer treatment for aphasia post stroke (Big CACTUS): study protocol for a randomised controlled trial.

Science.gov (United States)

Palmer, Rebecca; Cooper, Cindy; Enderby, Pam; Brady, Marian; Julious, Steven; Bowen, Audrey; Latimer, Nicholas

2015-01-27

Aphasia affects the ability to speak, comprehend spoken language, read and write. One third of stroke survivors experience aphasia. Evidence suggests that aphasia can continue to improve after the first few months with intensive speech and language therapy, which is frequently beyond what resources allow. The development of computer software for language practice provides an opportunity for self-managed therapy. This pragmatic randomised controlled trial will investigate the clinical and cost effectiveness of a computerised approach to long-term aphasia therapy post stroke. A total of 285 adults with aphasia at least four months post stroke will be randomly allocated to either usual care, computerised intervention in addition to usual care or attention and activity control in addition to usual care. Those in the intervention group will receive six months of self-managed word finding practice on their home computer with monthly face-to-face support from a volunteer/assistant. Those in the attention control group will receive puzzle activities, supplemented by monthly telephone calls. Study delivery will be coordinated by 20 speech and language therapy departments across the United Kingdom. Outcome measures will be made at baseline, six, nine and 12 months after randomisation by blinded speech and language therapist assessors. Primary outcomes are the change in number of words (of personal relevance) named correctly at six months and improvement in functional conversation. Primary outcomes will be analysed using a Hochberg testing procedure. Significance will be declared if differences in both word retrieval and functional conversation at six months are significant at the 5% level, or if either comparison is significant at 2.5%. A cost utility analysis will be undertaken from the NHS and personal social service perspective. Differences between costs and quality-adjusted life years in the three groups will be described and the incremental cost effectiveness ratio

21st Century Combat Post-Traumatic Stress: An Effective and Resilient Military Force

Science.gov (United States)

2012-03-30

post traumatic stress disorder ( PTSD ). Although it mentions...it. But what about the invisible wounds service members receive? Post Traumatic Stress Disorder (which will be referred to as PTSD throughout the... PTSD - Post Traumatic Stress Disorder RAND - Research and Development RCTs - Randomized Clinical Trial SUD - Substance

A randomized controlled trial on early physiotherapy intervention versus usual care in acute care unit for elderly: potential benefits in light of dietary intakes.

NARCIS (Netherlands)

Blanc-Bisson, C.; Dechamps, A.A.; Gouspillou, G.; Dehail, P.; Bourdel-Marchasson, I.

2008-01-01

OBJECTIVE: To evaluate effects of early intensive physiotherapy during acute illness on post hospitalization activity daily living autonomy (ADL). DESIGN: Prospective randomized controlled trial of intensive physiotherapy rehabilitation on day 1 to 2 after admission until clinical stability or usual

The utility of e-Learning to support training for a multicentre bladder online adaptive radiotherapy trial (TROG 10.01-BOLART).

Science.gov (United States)

Foroudi, Farshad; Pham, Daniel; Bressel, Mathias; Tongs, David; Rolfo, Aldo; Styles, Colin; Gill, Suki; Kron, Tomas

2013-10-01

An e-Learning programme appeared useful for providing training and information regarding a multi-centre image guided radiotherapy trial. The aim of this study is to demonstrate the utility of this e-Learning programme. Modules were created on relevant pelvic anatomy, Cone Beam CT soft tissue recognition and trial details. Radiation therapist participants' knowledge and confidence were evaluated before, at the end of, and after at least 6 weeks of e-Learning (long term). One hundred and eighty-five participants were recruited from 12 centres, with 118 in the first, and 67 in the second cohort. One hundred and forty-six participants had two tests (pre and post e-Learning) and 39 of these had three tests (pre, post, and long term). There was an increase confidence after completion of modules (pe-Learning for a multi-centre clinical trial was feasible and improved confidence and knowledge. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

[Evaluation of Web-based software applications for administrating and organising an ophthalmological clinical trial site].

Science.gov (United States)

Kortüm, K; Reznicek, L; Leicht, S; Ulbig, M; Wolf, A

2013-07-01

The importance and complexity of clinical trials is continuously increasing, especially in innovative specialties like ophthalmology. Therefore an efficient clinical trial site organisational structure is essential. In modern internet times, this can be accomplished by web-based applications. In total, 3 software applications (Vibe on Prem, Sharepoint and open source software) were evaluated in a clinical trial site in ophthalmology. Assessment criteria were set; they were: reliability, easiness of administration, usability, scheduling, task list, knowledge management, operating costs and worldwide availability. Vibe on Prem customised by the local university met the assessment criteria best. Other applications were not as strong. By introducing a web-based application for administrating and organising an ophthalmological trial site, studies can be conducted in a more efficient and reliable manner. Georg Thieme Verlag KG Stuttgart · New York.

Cost-utility analysis of a one-time supervisor telephone contact at 6-weeks post-partum to prevent extended sick leave following maternity leave in The Netherlands: results of an economic evaluation alongside a randomized controlled trial.

Science.gov (United States)

Uegaki, Kimi; Stomp-van den Berg, Suzanne G M; de Bruijne, Martine C; van Poppel, Mireille N M; Heymans, Martijn W; van Mechelen, Willem; van Tulder, Maurits W

2011-01-27

Working women of childbearing age are a vital part of the population. Following childbirth, this group of women can experience a myriad of physical and mental health problems that can interfere with their ability to work. Currently, there is little known about cost-effective post-partum interventions to prevent work disability. The purpose of the study was to evaluate whether supervisor telephone contact (STC) during maternity leave is cost-effective from a societal perspective in reducing sick leave and improving quality-adjusted life years (QALYs) compared to common practice (CP). We conducted an economic evaluation alongside a randomized controlled trial. QALYs were measured by the EuroQol 5-D, and sick leave and presenteeism by the Health and work Performance Questionnaire. Resource use was collected by questionnaires. Data were analysed according to intention-to-treat. Missing data were imputed via multiple imputation. Uncertainty was estimated by 95% confidence intervals, cost-utility planes and curves, and sensitivity analyses. 541 working women from 15 companies participated. Response rates were above 85% at each measurement moment. At the end of the follow-up, no statistically significant between-group differences in QALYs, mean hours of sick leave or presenteeism or costs were observed. STC was found to be less effective and more costly. For willingness-to-pay levels from €0 through €50,000, the probability that STC was cost-effective compared to CP was 0.2. Overall resource use was low. Mean total costs were €3678 (95% CI: 3386; 3951). Productivity loss costs represented 37% of the total costs and of these costs, 48% was attributable to sick leave and 52% to work presenteeism. The cost analysis from a company's perspective indicated that there was a net cost associated with the STC intervention. STC was not cost-effective compared to common practice for a healthy population of working mothers; therefore, implementation is not indicated. The cost

Post-error action control is neurobehaviorally modulated under conditions of constant speeded response

Directory of Open Access Journals (Sweden)

Takahiro eSoshi

2015-01-01

Full Text Available Post-error slowing is an error recovery strategy that contributes to action control, and occurs after errors in order to prevent future behavioral flaws. Error recovery often malfunctions in clinical populations, but the relationship between behavioral traits and recovery from error is unclear in healthy populations. The present study investigated the relationship between impulsivity and error recovery by simulating a speeded response situation using a Go/No-go paradigm that forced the participants to constantly make accelerated responses prior to stimuli disappearance (stimulus duration: 250 ms. Neural correlates of post-error processing were examined using event-related potentials (ERPs. Impulsivity traits were measured with self-report questionnaires (BIS-11, BIS/BAS. Behavioral results demonstrated that the commission error for No-go trials was 15%, but post-error slowing did not take place immediately. Delayed post-error slowing was negatively correlated with error rates and impulsivity traits, showing that response slowing was associated with reduced error rates and changed with impulsivity. Response-locked error ERPs were clearly observed for the error trials. Contrary to previous studies, error ERPs were not significantly related to post-error slowing. Stimulus-locked N2 was negatively correlated with post-error slowing and positively correlated with impulsivity traits at the second post-error Go trial: larger N2 activity was associated with greater post-error slowing and less impulsivity. In summary, under constant speeded conditions, error monitoring was dissociated from post-error action control, and post-error slowing did not occur quickly. Furthermore, post-error slowing and its neural correlate (N2 were modulated by impulsivity traits. These findings suggest that there may be clinical and practical efficacy of maintaining cognitive control of actions during error recovery under common daily environments that frequently evoke

Evaluation of the quality of the reporting of phase II clinical trials in oncology: A systematic review.

Science.gov (United States)

Rivoirard, Romain; Langrand-Escure, Julien; Oriol, Mathieu; Tinquaut, Fabien; Chauvin, Franck; Rancoule, Chloé; Magné, Nicolas; Bourmaud, Aurélie

2018-05-01

To describe the current state of knowledge concerning the quality of reporting in phase II clinical trials in oncology and to describe the various methods published allowing this quality evaluation. databases including MEDLINE and COCHRANE were searched. Reviews and meta-analyses analyzing the quality of the reporting of phase II trials in oncology were included. Descriptive analysis of the results was performed. Thirteen publications were retained. Only 2 publications adopted a systematic approach of evaluation of the quality of reporting by overall scores. The Key Methodological Score (KMS), proposed by Grellety et al., gathering 3 items, seemed adapted for such an evaluation. A score of 3/3 was found in 16.1% of the 156 phase II trials analysed by this score. The other reviews used a qualitative analysis to evaluate the reporting, via an analysis of a single criterion, generally the statistical plan of the study. This item was considered as having been correctly reported in less than 50% of the analysed articles. The quality of reporting in phase II trials in oncology is a field that has been investigated very little (13 publications). When it is studied, the estimated level of quality is not satisfactory, whatever the method employed. The use of an overall score of evaluation is a path which should be pursued, in order to get reliable results. It also seems necessary to propose strong recommendations, which would create a consensus for the methodology and the reporting of these studies. Copyright © 2018 Elsevier B.V. All rights reserved.

Ankle manual therapy for individuals with post-acute ankle sprains: description of a randomized, placebo-controlled clinical trial.

Science.gov (United States)

Davenport, Todd E; Kulig, Kornelia; Fisher, Beth E

2010-10-19

Ankle sprains are common within the general population and can result in prolonged disablement. Limited talocrural dorsiflexion range of motion (DF ROM) is a common consequence of ankle sprain. Limited talocrural DF ROM may contribute to persistent symptoms, disability, and an elevated risk for re-injury. As a result, many health care practitioners use hands-on passive procedures with the intention of improving talocrural joint DF ROM in individuals following ankle sprains. Dosage of passive hands-on procedures involves a continuum of treatment speeds. Recent evidence suggests both slow- and fast-speed treatments may be effective to address disablement following ankle sprains. However, these interventions have yet to be longitudinally compared against a placebo study condition. We developed a randomized, placebo-controlled clinical trial designed to test the hypotheses that hands-on treatment procedures administered to individuals following ankle sprains during the post-acute injury period can improve short-, intermediate-, and long-term disablement, as well as reduce the risk for re-injury. This study is designed to measure the clinical effects of hands-on passive stretching treatment procedures directed to the talocrural joint that vary in treatment speed during the post-acute injury period, compared to hands-on placebo control intervention. http://www.clinicaltrials.gov identifier NCT00888498.

Using Poisson-gamma model to evaluate the duration of recruitment process when historical trials are available.

Science.gov (United States)

Minois, Nathan; Lauwers-Cances, Valérie; Savy, Stéphanie; Attal, Michel; Andrieu, Sandrine; Anisimov, Vladimir; Savy, Nicolas

2017-10-15

At the design of clinical trial operation, a question of a paramount interest is how long it takes to recruit a given number of patients. Modelling the recruitment dynamics is the necessary step to answer this question. Poisson-gamma model provides very convenient, flexible and realistic approach. This model allows predicting the trial duration using data collected at an interim time with very good accuracy. A natural question arises: how to evaluate the parameters of recruitment model before the trial begins? The question is harder to handle as there are no recruitment data available for this trial. However, if there exist similar completed trials, it is appealing to use data from these trials to investigate feasibility of the recruitment process. In this paper, the authors explore the recruitment data of two similar clinical trials (Intergroupe Francais du Myélome 2005 and 2009). It is shown that the natural idea of plugging the historical rates estimated from the completed trial in the same centres of the new trial for predicting recruitment is not a relevant strategy. In contrast, using the parameters of a gamma distribution of the rates estimated from the completed trial in the recruitment dynamic model of the new trial provides reasonable predictive properties with relevant confidence intervals. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

A random walk model for evaluating clinical trials involving serial observations.

Science.gov (United States)

Hopper, J L; Young, G P

1988-05-01

For clinical trials where the variable of interest is ordered and categorical (for example, disease severity, symptom scale), and where measurements are taken at intervals, it might be possible to achieve a greater discrimination between the efficacy of treatments by modelling each patient's progress as a stochastic process. The random walk is a simple, easily interpreted model that can be fitted by maximum likelihood using a maximization routine with inference based on standard likelihood theory. In general the model can allow for randomly censored data, incorporates measured prognostic factors, and inference is conditional on the (possibly non-random) allocation of patients. Tests of fit and of model assumptions are proposed, and application to two therapeutic trials of gastroenterological disorders are presented. The model gave measures of the rate of, and variability in, improvement for patients under different treatments. A small simulation study suggested that the model is more powerful than considering the difference between initial and final scores, even when applied to data generated by a mechanism other than the random walk model assumed in the analysis. It thus provides a useful additional statistical method for evaluating clinical trials.

Effectiveness of a facebook-delivered physical activity intervention for post-partum women: a randomized controlled trial protocol.

Science.gov (United States)

Kernot, Jocelyn; Olds, Tim; Lewis, Lucy K; Maher, Carol

2013-05-29

Physical activity is reduced during the post-partum period. Facebook is frequently used by Australian mothers, and offers flexibility, high levels of engagement and the ability to disseminate information and advice via social contacts. The Mums Step it Up Program is a newly developed 50 day team-based physical activity intervention delivered via a Facebook app. The program involves post-partum women working in teams of 4-8 friends aiming to achieve 10,000 steps per day measured by a pedometer. Women are encouraged to use the app to log their daily steps and undertake social and supportive interactions with their friends and other participants. This study aims to determine the effectiveness of the Mums Step it Up Program. A sample of 126 women up to 12 months post-partum will be recruited through community-based health and family services. Participants will be randomly allocated into one of three groups: control, pedometer only and the Mums Step it Up Program. Assessments will be completed at baseline, 6 weeks and 6 months. The primary outcome (objective physical activity) and the secondary outcomes (sleep quality and quantity, depressive symptoms, weight and quality of life) will be used to determine the effectiveness of the Mums Step it Up Program compared with the control and pedometer only groups. Analyses will be undertaken on an intention-to-treat-basis using random effects mixed modeling. The effect of theorized mediators (physical activity attitudes, subjective norms and perceived behavioral control) will also be examined. This study will provide information about the potential of a Facebook app for the delivery of health behavior interventions. If this intervention proves to be effective it will be released on a mass scale and promoted to the general public. Australia and New Zealand Clinical Trials Register: ACTRN12613000069752.

Evaluation of Wet Cupping Therapy: Systematic Review of Randomized Clinical Trials.

Science.gov (United States)

Al Bedah, Abdullah M N; Khalil, Mohamed K M; Posadzki, Paul; Sohaibani, Imen; Aboushanab, Tamer Shaaban; AlQaed, Meshari; Ali, Gazzaffi I M

2016-10-01

Wet cupping is a widely used traditional therapy in many countries, which justifies a continuous scientific evaluation of its efficacy and safety. To perform a systematic review to critically evaluate and update the available evidence of wet cupping in traditional and complementary medicine. Ten electronic databases were searched from their inceptions to February 2016. Included studies were randomized clinical trials (RCTs) that evaluated wet cupping against any type of control interventions in patients with any clinical condition, as well as healthy individuals. Cochrane risk of bias tool was used to appraise the included RCTs. Fourteen RCTs met the eligibility criteria. The included studies evaluated the following clinical conditions: nonspecific low back pain (NSLBP), hypertension, brachialgia, carpal tunnel syndrome (CTS), chronic neck pain, metabolic syndrome, migraine headaches, oxygen saturation in smokers with chronic obstructive pulmonary disease (COPD), and oral and genital ulcers due to Behçet disease. Two RCTs evaluated physiologic and biochemical parameters of healthy individuals. Overall, 9 RCTs favored wet cupping over various control interventions in NSLBP (n = 2), hypertension (n = 1), brachialgia (n = 1), CTS (n = 1), chronic neck pain (n = 2), oxygen saturation in smokers with COPD (n = 1), and oral and genital ulcers due to Behçet disease (n = 1). Five RCTs showed no statistically significant between-group differences: NSLBP (n = 1), metabolic syndrome (n = 1), migraine headaches (n = 1), and physiologic and biochemical parameters of healthy individuals (n = 2). Included RCTs had a variable risk of bias across all domains and suffered methodologic limitations. There is a promising evidence in favor of the use of wet cupping for musculoskeletal pain, specifically NSLBP, neck pain, CTS, and brachialgia. Better-quality trials are needed to generate solid evidence and firmly inform policy makers.

Pilot randomized controlled trial of dialectical behavior therapy group skills training for ADHD among college students.

Science.gov (United States)

Fleming, Andrew P; McMahon, Robert J; Moran, Lyndsey R; Peterson, A Paige; Dreessen, Anthony

2015-03-01

ADHD affects between 2% and 8% of college students and is associated with broad functional impairment. No prior randomized controlled trials with this population have been published. The present study is a pilot randomized controlled trial evaluating dialectical behavior therapy (DBT) group skills training adapted for college students with ADHD. Thirty-three undergraduates with ADHD between ages 18 and 24 were randomized to receive either DBT group skills training or skills handouts during an 8-week intervention phase. ADHD symptoms, executive functioning (EF), and related outcomes were assessed at baseline, post-treatment, and 3-month follow-up. Participants receiving DBT group skills training showed greater treatment response rates (59-65% vs. 19-25%) and clinical recovery rates (53-59% vs. 6-13%) on ADHD symptoms and EF, and greater improvements in quality of life. DBT group skills training may be efficacious, acceptable, and feasible for treating ADHD among college students. A larger randomized trial is needed for further evaluation. © 2014 SAGE Publications.

Evaluation of role of brain SPECT in diagnosis of post stroke dementia

International Nuclear Information System (INIS)

Yousepour, G.; Alavi, M.

2003-01-01

Post stroke dementia is one of the most common complications of stroke that is preventable and relatively treatable too. The purpose of the study is comparison between the positive findings in the brain CT scan and brain perfusion SPECT. 15 patients who were complicated by dementia after cerebrovascular accident and also 5 patients as a control group enrolled in this study. Brain CT scan and brain SPECT were performed during at most one week after stroke. Abnormal findings in both brain CT scan and SPECT were seen in 46% of patients. Brain CT scan disclosed more abnormal findings compared to brain SPECT (33.3%). While brain SPECT findings were more information than brain CT scan (20%) this study is indicating that brain CT scan and the brain SPECT concomitantly for each other in better diagnosis of post stroke dementia. We did not find any specific diagnostic pattern in brain SPECT of patients suffering from post stroke dementia. The low quality of brain SPECT in spite of uniformity of gamma camera may be suggestive of low quality of Iran produced ECD kit that needs further evaluation

Pregabalin for the treatment of postoperative pain: results from three controlled trials using different surgical models

Directory of Open Access Journals (Sweden)

Singla NK

2014-12-01

Full Text Available Neil K Singla,1 Jacques E Chelly,2 David R Lionberger,3 Joseph Gimbel,4 Luis Sanin,5 Jonathan Sporn,5 Ruoyong Yang,5 Raymond Cheung,5 Lloyd Knapp,6 Bruce Parsons5 1Lotus Clinical Research, Pasadena, CA, USA; 2Division of Acute Interventional Perioperative Pain, Department of Anesthesiology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA; 3Department of Orthopedic Surgery, Baylor College of Medicine, Houston, TX, USA; 4Arizona Research Center, Phoenix, AZ, USA; 5Pfizer Inc., New York, NY, USA; 6Pfizer Inc., New London, CT, USA Purpose: To evaluate the efficacy and safety of pregabalin (150 or 300 mg/d as an adjunctive therapy for the treatment of postoperative pain. Patients and methods: This study reports findings from three separate, multicenter, randomized, double-blind, placebo-controlled trials of adjunctive pregabalin for the treatment of postoperative pain. Patients underwent one of three categories of surgical procedures (one procedure per study: elective inguinal hernia repair (post-IHR; elective total knee arthroplasty (post-TKA; or total abdominal hysterectomy (posthysterectomy. The primary endpoint in each trial, mean worst pain over the past 24 hours, was assessed 24 hours post-IHR and posthysterectomy, and 48 hours post-TKA. Patients rated their pain on a scale from 0 to 10, with higher scores indicating greater pain severity. Results: In total, 425 (post-IHR, 307 (post-TKA, and 501 (posthysterectomy patients were randomized to treatment. There were no statistically significant differences between the pregabalin and placebo groups with respect to the primary endpoint in any of the three trials. The least squares mean difference in worst pain, between 300 mg/d pregabalin and placebo, was -0.7 (95% confidence interval [CI] =-1.4, -0.1; Hochberg adjusted P=0.067 post-IHR; -0.34 (95% CI =-1.07, 0.39; P=0.362 post-TKA; and -0.2 (95% CI =-0.66, 0.31; P=0.471 posthysterectomy. Conclusion: There were no significant differences

The Post-Intervention Persistence of Energy Conservation Behaviors: An Evaluation of the ‘Start Green’ Program

Directory of Open Access Journals (Sweden)

S. Barnett Burns

2018-03-01

Full Text Available For more than four decades, behavioral intervention programs informed by psychology have been employed to increase pro-environmental behaviors. However, there has been little evidence for the post-intervention durability of target behaviors. The few studies that have conducted such evaluations have found that improvements often return to baseline levels post-intervention. This study evaluated the durability of home energy conservation behaviors before, during, and after a community based multi-technique intervention program, and examined the relationship between behavioral durability and the perceived importance, convenience and family norms of each behavior, as well as generalized pro-conservation decision making. The results show increased frequency in target behaviors that remain elevated seven months post-intervention. While the reported generalization of pro-conservation decision-making consistently increased during the study, perceived importance, convenience, and family norms of target conservation behaviors were largely unaffected. In addition, the few significant alterations in these perceptions were found to be due to increases during the post-intervention period only, indicating that they are not necessary pre-requisites for durable behavior change. These results show that a well designed community based intervention can have direct impacts on target behaviors that persist beyond its termination.

Outcome reporting across randomised trials and observational studies evaluating treatments for Twin-Twin Transfusion Syndrome: a systematic review.

Science.gov (United States)

Perry, Helen; Duffy, James M N; Umadia, Ogochukwu; Khalil, Asma

2018-04-01

Twin-Twin Transfusion syndrome is associated with significant mortality and morbidity. Potential treatments require robust evaluation. The aim of this study was to evaluate outcome reporting across observational studies and randomised controlled trials assessing treatments for twin-twin transfusion syndrome (TTTS). Cochrane Central Register of Controlled Trials, EMBASE and Medline were searched from inception to August 2016. Observational studies and randomised controlled trials reporting outcomes following a treatment for TTTS in monochorionic-diamniotic twin pregnancies and monochorionic-triamniotic or dichorionic-triamniotic triplet pregnancies were included. We systematically extracted and categorised outcome reporting. Six randomised trials and 94 observational studies, reporting data from 20,071 maternal participants and 3,199 children, were included. Six different treatments were evaluated. Included studies reported sixty-two different outcomes, including 10 fetal, 28 neonatal, 6 early childhood and 18 maternal outcomes. The outcomes were inconsistently reported across trials. For example, when considering offspring mortality, 31 studies (31%) reported live birth, 31 studies (31%) reported intrauterine death, 49 studies (49%) reported neonatal mortality, and 17 studies (17%) reported perinatal mortality. Four studies (4%) reported respiratory distress syndrome. Only 19 (19%) of studies were designed for long-term follow-up and 11 of these studies (11%) reported cerebral palsy. Most studies evaluating treatments for TTTS, have often neglected to report clinically important outcomes, especially neonatal morbidity outcomes. Most studies are not designed for long-term follow-up. The development of a core outcome set could help standardised outcome collection and reporting in Twin-Twin Transfusion syndrome studies. This article is protected by copyright. All rights reserved.

Pilot Randomized Controlled Trial of Internet-Delivered Cognitive-Behavioral Treatment for Pediatric Headache.

Science.gov (United States)

Law, Emily F; Beals-Erickson, Sarah E; Noel, Melanie; Claar, Robyn; Palermo, Tonya M

2015-01-01

To evaluate the feasibility and preliminary effectiveness of an Internet-delivered cognitive-behavioral therapy (CBT) intervention for adolescents with chronic headache. Headache is among the most common pain complaints of childhood. Cognitive-behavioral interventions are efficacious for improving pain among youth with headache. However, many youth do not receive psychological treatment for headache due to poor access, which has led to consideration of alternative delivery modalities such as the Internet. We used a parallel arm randomized controlled trial design to evaluate the feasibility and preliminary effectiveness of an Internet-delivered family-based CBT intervention, Web-based management of adolescent pain. Adolescents were eligible for the trial if they were a new patient being evaluated in a specialized headache clinic, between 11 and 17 years of age, and had recurrent headache for 3 months or more as diagnosed by a pediatric neurologist. Eighty-three youths were enrolled in the trial. An online random number generator was used to randomly assign participants to receive Internet CBT adjunctive to specialized headache treatment (n = 44) or specialized headache treatment alone (n = 39). The primary treatment outcome was headache days. Youth and parents in the Internet CBT group demonstrated high levels of engagement with the web program and reported satisfaction with the intervention. Multilevel modelling (MLM) was used to conduct hypothesis testing for continuous outcomes. For our primary treatment outcome of headache days, adolescents reported a statistically significant reduction in headache days from baseline to post-treatment and baseline to 3-month follow-up in both treatment conditions (main effect for time F(2, 136) = 19.70, P headache treatment group at post-treatment or follow-up (group × time interaction F(2, 134) = 0.94, P = .395). For our secondary treatment outcomes, findings from MLM showed that adolescents in both

Evaluation of patient-rated stiffness associated with fibromyalgia: a post-hoc analysis of 4 pooled, randomized clinical trials of duloxetine.

Science.gov (United States)

Bennett, Robert; Russell, I Jon; Choy, Ernest; Spaeth, Michael; Mease, Philip; Kajdasz, Daniel; Walker, Daniel; Wang, Fujun; Chappell, Amy

2012-04-01

Patients with fibromyalgia (FM) rate stiffness as one of the most troublesome symptoms of the disorder. However, there are few published studies that have focused on better understanding the nature of stiffness in FM. The primary objectives of these analyses were to characterize the distribution of stiffness severity in patients at baseline, evaluate changes in stiffness after 12 weeks of treatment with duloxetine, and determine which outcomes were correlated with stiffness. These were post-hoc analyses of 3-month data from 4 randomized, double-blind, placebo-controlled studies that assessed efficacy of duloxetine in adults with FM. Severity of stiffness was assessed by using the Fibromyalgia Impact Questionnaire (FIQ) on a scale from 0 (no stiffness) to 10 (most severe stiffness). The association between changes in stiffness and other measures was evaluated by using Pearson's correlation coefficient. The FIQ total score and items, the Brief Pain Inventory (BPI-modified short form), the Clinical Global Impression-Severity scale, the Multidimensional Fatigue Inventory, the 17-item Hamilton Depression Rating Scale, the Sheehan Disability Scale, the 36-item Short-Form Health Survey, and the EuroQoL Questionnaire-5 Dimensions were evaluated in the correlation analyses. Stepwise linear regression was used to identify the variables that were most highly predictive of the changes in FIQ stiffness. The analysis included 1332 patients (mean age, 50.2 years; 94.7% female; and 87.8% white). The mean (SD) baseline FIQ stiffness score was 7.7 (2.0), and this score correlated with baseline BPI pain score and FIQ function. Duloxetine significantly improved the FIQ stiffness score compared with placebo (P FIQ pain and interference scores, FIQ nonrefreshing sleep, FIQ anxiety, 36-item Short-Form Health Survey bodily pain, and Sheehan Disability Scale total score. Variables related to severity of pain, pain interfering with daily activities, and physical functioning were predictors

Pediatric dentistry clinical education venues evaluation by pre and post-doctoral students.

Science.gov (United States)

Bimstein, E; Mayes, A; Mittal, Hc

2014-01-01

To evaluate dental students' perspectives about pre- and post-doctoral pediatric dentistry education venues. Surveys with visual analog scales (from 0 to 100) measuring the educational contribution of pediatric dentistry venues were conducted. The pre-doctoral venues included a 3rd year university twilight clinic (UTC), a 3rd year urban community based clinic (CBC) and 4th year mobile clinics (MCs). The post-doctoral venues included treatment of children under general anesthesia, oral sedations, a regular clinic (no sedations), seminars, journal club, case conferences and studding for the American Board of Pediatric Dentistry. Analyses of variance between the scores indicated that the 3rd year CBC score (68.2 ± 4.5) was statistically significant higher (p= .007) than the one for the 3rd year UTC score (44.9 ± 6.1). The 4th year students' MCs score (61.4 ± 4.0) was statistically significant higher than their retrospective scores for the 3rd year CBC (56.4 ± 4.4) or UTC (42.2 ± 4.9) scores (p= .03 and .004 respectively). Among the didactic or clinical post-doctoral venues, the regular clinic and the seminars received the highest scores (84.3 ± 1.7 and 71.6 ± 2.8 respectively). pre-doctoral community-based clinical education and post-doctoral regular university based clinic are considered by students to provide the main contribution to pediatric dental education.

Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and best practices. A report from the cardiac safety research consortium.

Science.gov (United States)

Seltzer, Jonathan H; Heise, Ted; Carson, Peter; Canos, Daniel; Hiatt, Jo Carol; Vranckx, Pascal; Christen, Thomas; Cutlip, Donald E

2017-08-01

This white paper provides a summary of presentations, discussions and conclusions of a Thinktank entitled "The Role of Endpoint Adjudication in Medical Device Clinical Trials". The think tank was cosponsored by the Cardiac Safety Research Committee, MDEpiNet and the US Food and Drug Administration (FDA) and was convened at the FDA's White Oak headquarters on March 11, 2016. Attention was focused on tailoring best practices for evaluation of endpoints in medical device clinical trials, practical issues in endpoint adjudication of therapeutic, diagnostic, biomarker and drug-device combinations, and the role of adjudication in regulatory and reimbursement issues throughout the device lifecycle. Attendees included representatives from medical device companies, the FDA, Centers for Medicare and Medicaid Services (CMS), end point adjudication specialist groups, clinical research organizations, and active, academically based adjudicators. The manuscript presents recommendations from the think tank regarding (1) rationale for when adjudication is appropriate, (2) best practices establishment and operation of a medical device adjudication committee and (3) the role of endpoint adjudication for post market evaluation in the emerging era of real world evidence. Copyright © 2017. Published by Elsevier Inc.

Effect of aliskiren on post-discharge outcomes among diabetic and non-diabetic patients hospitalized for heart failure: insights from the ASTRONAUT trial

Science.gov (United States)

Maggioni, Aldo P.; Greene, Stephen J.; Fonarow, Gregg C.; Böhm, Michael; Zannad, Faiez; Solomon, Scott D.; Lewis, Eldrin F.; Baschiera, Fabio; Hua, Tsushung A.; Gimpelewicz, Claudio R.; Lesogor, Anastasia; Gheorghiade, Mihai; Ramos, Silvina; Luna, Alejandra; Miriuka, Santiago; Diez, Mirta; Perna, Eduardo; Luquez, Hugo; Pinna, Jorge Garcia; Castagnino, Jorge; Alvarenga, Pablo; Ibañez, Julio; Blumberg, Eduardo Salmon; Dizeo, Claudio; Guerrero, Rodolfo Ahuad; Schygiel, Pablo; Milesi, Rodolfo; Sosa, Carlos; Hominal, Miguel; Marquez, Lilia Lobo; Poy, Carlos; Hasbani, Eduardo; Vico, Marisa; Fernandez, Alberto; Vita, Nestor; Vanhaecke, Johan; De Keulenaer, Gilles; Striekwold, Harry; Vervoort, Geert; Vrolix, Mathias; Henry, Philippe; Dendale, Paul; Smolders, Walter; Marechal, Patrick; Vandekerckhove, Hans; Oliveira, Mucio; Neuenschwande, Fernando; Reis, Gilmar; Saraiva, Jose; Bodanese, Luiz; Canesin, Manoel; Greco, Oswaldo; Bassan, Roberto; Marino, Roberto Luis; Giannetti, Nadia; Moe, Gordon; Sussex, Bruce; Sheppard, Richard; Huynh, Thao; Stewart, Robert; Haddad, Haissam; Echeverria, Luis; Quintero, Adalberto; Torres, Adriana; Jaramillo, Mónica; Lopez, Mónica; Mendoza, Fernan; Florez, Noel; Cotes, Carlos; Garcia, Magali; Belohlavek, Jan; Hradec, Jaromir; Peterka, Martin; Gregor, Pavel; Monhart, Zdenek; Jansky, Petr; Kettner, Jiri; Reichert, Petr; Spinar, Jindrich; Brabec, Tomas; Hutyra, Martin; Solar, Miroslav; Pietilä, Mikko; Nyman, Kai; Pajari, Risto; Cohen, Ariel; Galinier, Michel; Gosse, Philippe; Livarek, Bernard; Neuder, Yannick; Jourdain, Patrick; Picard, François; Isnard, Richard; Hoppe, Uta; Kaeaeb, Stefan; Rosocha, Stefan; Prondzinsky, Roland; Felix, Stephan; Duengen, Hans-Dirk; Figulla, Hans-Reiner; Fischer, Sven; Behrens, Steffen; Stawowy, Philipp; Kruells-Muench, Juergen; Knebel, Fabian; Nienaber, Christoph; Werner, Dierk; Aron, Wilma; Remppis, Bjoern; Hambrecht, Rainer; Kisters, Klaus; Werner, Nikos; Hoffmann, Stefan; Rossol, Siegbert; Geiss, Ernst; Graf, Kristof; Hamann, Frank; von Scheidt, Wolfgang; Schwinger, Robert; Tebbe, Ulrich; Costard-Jaeckle, Angelika; Lueders, Stephan; Heitzer, Thomas; Leutermann-Oei, Marie-Louise; Braun-Dullaeus, Ruediger; Roehnisch, Jens-Uwe; Muth, Gerhard; Goette, Andreas; Rotter, Achim; Ebelt, Henning; Olbrich, Hans-Georg; Mitrovic, Veselin; Hengstenberg, Christian; Schellong, Sebastian; Zamolyi, Karoly; Vertes, Andras; Matoltsy, Andras; Palinkas, Attila; Herczeg, Bela; Apro, Dezso; Lupkovics, Geza; Tomcsanyi, Janos; Toth, Kalman; Mathur, Atul; Banker, Darshan; Bharani, Anil; Arneja, Jaspal; Khan, Aziz; Gadkari, Milind; Hiremath, Jagdish; Patki, Nitin; Kumbla, Makund; Santosh, M.J.; Ravikishore, A.G.; Abhaichand, Rajpal; Maniyal, Vijayakukmar; Nanjappa, Manjunath; Reddy, P. Naveen; Chockalingam, Kulasekaran; Premchand, Rajendra; Mahajan, Vijay; Lewis, Basil; Wexler, Dov; Shochat, Michael; Keren, Andre; Omary, Muhamad; Katz, Amos; Marmor, Alon; Lembo, Giuseppe; Di Somma, Salvatore; Boccanelli, Alessandro; Barbiero, Mario; Pajes, Giuseppe; De Servi, Stefano; Greco, Dott Cosimo; De Santis, Fernando; Floresta, Agata; Visconti, Luigi Oltrona; Piovaccari, Giancarlo; Cavallini, Claudio; Di Biase, Matteo; Masini, Dott Franco; Vassanelli, Corrado; Viecca, Maurizio; Cangemi, Dott Francesco; Pirelli, Salvatore; Borghi, Claudio; Volpe, Massimo; Branzi, Angelo; Percoco, Dott Giovanni; Severi, Silvia; Santini, Alberto; De Lorenzi, Ettore; Metra, Marco; Zacà, Valerio; Mortara, Andrea; Tranquilino, Francisco P.; Babilonia, Noe A.; Ferrolino, Arthur M.; Manlutac, Benjamin; Dluzniewski, Miroslaw; Dzielinska, Zofia; Nowalany-Kozie, Ewa; Mazurek, Walentyna; Wierzchowiecki, Jerzy; Wysokinski, Andrzej; Szachniewicz, Joanna; Romanowski, Witold; Krauze-Wielicka, Magdalena; Jankowski, Piotr; Berkowski, Piotr; Szelemej, Roman; Kleinrok, Andrzej; Kornacewicz-Jac, Zdzislawa; Vintila, Marius; Vladoianu, Mircea; Militaru, Constantin; Dan, Gheorghe; Dorobantu, Maria; Dragulescu, Stefan; Kostenko, Victor; Vishnevsky, Alexandr; Goloschekin, Boris; Tyrenko, Vadim; Gordienko, Alexander; Kislyak, Oxana; Martsevich, Sergey; Kuchmin, Alexey; Karpov, Yurii; Fomin, Igor; Shvarts, Yury; Orlikova, Olga; Ershova, Olga; Berkovich, Olga; Sitnikova, Maria; Pakhomova, Inna; Boldueva, Svetlana; Tyurina, Tatiana; Simanenkov, Vladimir; Boyarkin, Mikhail; Novikova, Nina; Tereschenko, Sergey; Zadionchenko, Vladimir; Shogenov, Zaur; Gordeev, Ivan; Moiseev, Valentin; Wong, Raymond; Ong, Hean Yee; Le Tan, Ju; Goncalvesova, Eva; Kovar, Frantisek; Skalina, Ivan; Kasperova, Viera; Hojerova, Silvia; Szentivanyi, Miroslav; Stancak, Branislav; Babcak, Marian; Kycina, Peter; Poliacik, Pavol; Toth, Peter; Sirotiakova, Jana; de Sa, Esteban Lopez; Bueno, Manuel Gomez; Selles, Manuel Martinez; Cabrera, Jose Angel; Freire, Ramon Bover; Gonzalez Juanatey, Jose Ramon; Comin, Josep; Soriano, FranciscoRidocci; Lopez, Alejandro; Vicho, Raul; Lama, Manuel Geraldia; Schaufelberger, Maria; Brunotte, Richard; Ullman, Bengt; Hagerman, Inger; Cizinsky, Stella; Cherng, Wen-Jin; Yu, Wen-Chung; Kuo, Chi-Tai; Chang, Kuan-Cheng; Lai, Wen-Ter; Kuo, Jen-Yuan; Ural, Dilek; Badak, Ozer; Akin, Mustafa; Yigit, Zerrin; Yokusoglu, Mehmet; Yilmaz, Mehmet; Abaci, Adnan; Ebinc, Haksun; Perlman, Richard; Parish, David; Bergin, James; Burnham, Kenneth; Brown, Christopher; Lundbye, Justin; Williams, Celeste; Eisen, Howard; Juneman, Elizabeth; Joseph, Susan; Peberdy, Mary Ann; Peura, Jennifer; Gupta, Vishal; Habet, Kalim; French, William; Mody, Freny; Graham, Susan; Hazelrigg, Monica; Chung, Eugene; Dunlap, Stephanie; Nikolaidis, Lazaros; Najjar, Samer; Katz, Richard; Murali, Srinivas; Izzo, Joseph L.; Callister, Tracy; Phillips, Roland; Lippolis, Nicholas; Winterton, John; Meymandi, Sheba; Heilman, Karl; Oren, Ron; Zolty, Ronald; Brottman, Michael; Gunawardena, D.R.; Adams, Kirkwood; Barnard, Denise; Klapholz, Marc; Fulmer, James

2013-01-01

Aims The objective of the Aliskiren Trial on Acute Heart Failure Outcomes (ASTRONAUT) was to determine whether aliskiren, a direct renin inhibitor, would improve post-discharge outcomes in patients with hospitalization for heart failure (HHF) with reduced ejection fraction. Pre-specified subgroup analyses suggested potential heterogeneity in post-discharge outcomes with aliskiren in patients with and without baseline diabetes mellitus (DM). Methods and results ASTRONAUT included 953 patients without DM (aliskiren 489; placebo 464) and 662 patients with DM (aliskiren 319; placebo 343) (as reported by study investigators). Study endpoints included the first occurrence of cardiovascular death or HHF within 6 and 12 months, all-cause death within 6 and 12 months, and change from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) at 1, 6, and 12 months. Data regarding risk of hyperkalaemia, renal impairment, and hypotension, and changes in additional serum biomarkers were collected. The effect of aliskiren on cardiovascular death or HHF within 6 months (primary endpoint) did not significantly differ by baseline DM status (P = 0.08 for interaction), but reached statistical significance at 12 months (non-DM: HR: 0.80, 95% CI: 0.64–0.99; DM: HR: 1.16, 95% CI: 0.91–1.47; P = 0.03 for interaction). Risk of 12-month all-cause death with aliskiren significantly differed by the presence of baseline DM (non-DM: HR: 0.69, 95% CI: 0.50–0.94; DM: HR: 1.64, 95% CI: 1.15–2.33; P < 0.01 for interaction). Among non-diabetics, aliskiren significantly reduced NT-proBNP through 6 months and plasma troponin I and aldosterone through 12 months, as compared to placebo. Among diabetic patients, aliskiren reduced plasma troponin I and aldosterone relative to placebo through 1 month only. There was a trend towards differing risk of post-baseline potassium ≥6 mmol/L with aliskiren by underlying DM status (non-DM: HR: 1.17, 95% CI: 0.71–1.93; DM: HR: 2.39, 95% CI: 1.30�

Review of Post-Marketing Safety Data on Tapentadol, a Centrally Acting Analgesic.

Science.gov (United States)

Stollenwerk, Ariane; Sohns, Melanie; Heisig, Fabian; Elling, Christian; von Zabern, Detlef

2018-01-01

Tapentadol is a centrally acting analgesic that has been available for the management of acute and chronic pain in routine clinical practice since 2009. This is the first integrated descriptive analysis of post-marketing safety data following the use of tapentadol in a broad range of pain conditions relating to the topics overall safety, dose administration above approved dosages, administration during pregnancy, serotonin syndrome, respiratory depression, and convulsion. The data analyzed pertain to spontaneous reports from healthcare and non-healthcare professionals and were put in the context of safety information known from interventional and non-interventional trials. The first years of routine clinical practice experience with tapentadol have confirmed the tolerability profile that emerged from the clinical trials. Moreover, the reporting of expected side effects such as respiratory depression and convulsion was low and no major risks were identified. The evaluation of available post-marketing data did not confirm the theoretical risk of serotonin syndrome nor did it reveal unexpected side effects with administration of higher than recommended doses. More than 8 years after its first introduction, the favorable overall safety profile of tapentadol in the treatment of various pain conditions is maintained in the general population. Grünenthal GmbH.

The influence of repeated abutment changes on peri-implant tissue stability: 3-year post-loading results from a multicentre randomised controlled trial.

Science.gov (United States)

Bressan, Eriberto; Grusovin, Maria Gabriella; D'Avenia, Ferdinando; Neumann, Konrad; Sbricoli, Luca; Luongo, Giuseppe; Esposito, Marco

increased marginal bone loss (difference = 0.1 mm, CI 95%: -0.3, 0.5, P = 0.590) or buccal recessions (difference = 0.1 mm, CI 95%: -0.4, 0.7, P = 0.674) at implants with less than 2 mm of keratinised mucosa at loading. Three-year post-loading data showed that repeated abutment disconnections significantly increased bone loss of 0.43 mm, but this difference may not be considered clinically relevant; therefore clinicians can use the procedure they find more convenient for each specific patient. Immediately non-occlusally loaded dental implants are a viable alternative to conventional loading and no increased bone loss or buccal recessions were noticed at implants with less than 2 mm of keratinised mucosa. Conflict of interest statement: This trial was partially funded by Dentsply Sirona Implants, the manufacturer of the implants and other products evaluated in this investigation. However, data belonged to the authors and by no means did the manufacturer interfere with the conduct of the trial or the publication of the results, with the exception of rejecting a proposal to change the protocol, after the trial was started, allowing the use of indexed abutments.

Mesh fixation in endoscopic inguinal hernia repair: evaluation of methodology based on a systematic review of randomised clinical trials.

Science.gov (United States)

Lederhuber, Hans; Stiede, Franziska; Axer, Stephan; Dahlstrand, Ursula

2017-11-01

The issue of mesh fixation in endoscopic inguinal hernia repair is frequently debated and still no conclusive data exist on differences between methods regarding long-term outcome and postoperative complications. The quantity of trials and the simultaneous lack of high-quality evidence raise the question how future trials should be planned. PubMed, EMBASE and the Cochrane Library were searched, using the filters "randomised clinical trials" and "humans". Trials that compared one method of mesh fixation with another fixation method or with non-fixation in endoscopic inguinal hernia repair were eligible. To be included, the trial was required to have assessed at least one of the following primary outcome parameters: recurrence; surgical site infection; chronic pain; or quality-of-life. Fourteen trials assessing 2161 patients and 2562 hernia repairs were included. Only two trials were rated as low risk for bias. Eight trials evaluated recurrence or surgical site infection; none of these could show significant differences between methods of fixation. Two of 11 trials assessing chronic pain described significant differences between methods of fixation. One of two trials evaluating quality-of-life showed significant differences between fixation methods in certain functions. High-quality evidence for differences between the assessed mesh fixation techniques is still lacking. From a socioeconomic and ethical point of view, it is necessary that future trials will be properly designed. As small- and medium-sized single-centre trials have proven unable to find answers, register studies or multi-centre studies with an evident focus on methodology and study design are needed in order to answer questions about mesh fixation in inguinal hernia repair.

A Scoping Review of Economic Evaluations Alongside Randomised Controlled Trials of Home Monitoring in Chronic Disease Management.

Science.gov (United States)

Kidholm, Kristian; Kristensen, Mie Borch Dahl

2018-04-01

Many countries have considered telemedicine and home monitoring of patients as a solution to the demographic challenges that health-care systems face. However, reviews of economic evaluations of telemedicine have identified methodological problems in many studies as they do not comply with guidelines. The aim of this study was to examine economic evaluations alongside randomised controlled trials of home monitoring in chronic disease management and hereby to explore the resources included in the programme costs, the types of health-care utilisation that change as a result of home monitoring and discuss the value of economic evaluation alongside randomised controlled trials of home monitoring on the basis of the studies identified. A scoping review of economic evaluations of home monitoring of patients with chronic disease based on randomised controlled trials and including information on the programme costs and the costs of equipment was carried out based on a Medline (PubMed) search. Nine studies met the inclusion criteria. All studies include both costs of equipment and use of staff, but there is large variation in the types of equipment and types of tasks for the staff included in the costs. Equipment costs constituted 16-73% of the total programme costs. In six of the nine studies, home monitoring resulted in a reduction in primary care or emergency contacts. However, in total, home monitoring resulted in increased average costs per patient in six studies and reduced costs in three of the nine studies. The review is limited by the small number of studies found and the restriction to randomised controlled trials, which can be problematic in this area due to lack of blinding of patients and healthcare professionals and the difficulty of implementing organisational changes in hospital departments for the limited period of a trial. Furthermore, our results may be based on assessments of older telemedicine interventions.

Increasing children's physical activity through a teaching-assistant led extracurricular intervention: process evaluation of the action 3:30 randomised feasibility trial.

Science.gov (United States)

Jago, Russell; Sebire, Simon J; Davies, Ben; Wood, Lesley; Banfield, Kathryn; Edwards, Mark J; Powell, Jane E; Montgomery, Alan A; Thompson, Janice L; Fox, Kenneth R

2015-02-18

Many children do not engage in recommended levels of physical activity (PA), highlighting the need to find ways to increase children's PA. Process evaluations play an important role in improving the science of randomised controlled trials. We recently reported the results of the Action 3:30 cluster randomised feasibility trial illustrating higher levels of moderate to vigorous intensity PA among boys but not girls. The aim of this paper is to report the process evaluation results including intervention fidelity, implementation, context and how intervention components and trial design could be improved before proceeding to a definitive RCT. Children's session enjoyment was assessed every two weeks. Reasons for non-attendance were provided by questionnaire at the end of the intervention. Post intervention interviews were held with participating teaching assistants (TAs) and school key contacts (KCs), and focus groups were conducted with children in all 10 intervention schools. Interviews and focus groups examined how recruitment and session attendance might be improved and established which elements of the programme that were and were not well received. Data indicated good intervention fidelity with TA's adopting enjoyment-focussed teaching styles and the sessions improving children's skills and self-esteem. Several positive aspects of implementation were identified, including high session variety, the opportunity to work in teams, the child-led sessions and the engaging leader style. In terms of context there was evidence that TA's faced difficulties managing challenging behaviour and that further training in this area was needed. TAs and KCs felt that recruitment could be improved by providing taster sessions during PE lessons and clarifying the days that the clubs would run at the point of recruitment. The programme could be improved to enhance interest for girls, by including training for managing disruptive behaviour and making some activities more age

Evaluation of post-ESWL renal sequelae using quantitative radionuclide studies

Energy Technology Data Exchange (ETDEWEB)

Moustafa, H; Elhaddad, SH; Ziada, G; El-Tawil, A [Nuclear medicine (Egypt); Hegazi, A; Fawzy, K [Urology departments Faculty of medicine, Cairo university, Cairo, (Egypt)

1995-10-01

45 adult patients with single, unilateral renal stones without back pressure change attended to Cairo University Hospital during 1990 and 1991 were treated with ESWl. All cases were subjected to radionuclide renal studies using 131 I-OIH and 99 mTc-DTPA done pre-, immediate post- and 3 months post-ESWL. No significant changes of total renal ERPF and GFR could be detected. Treated kidneys GFR, GFR%, ERPE and T max showed no significant changes after ESWL except for a transient significant improvement of their T 1/2 (P<0.04); that occurred immediately after ESWL. Contralateral kidneys showed only transient statistically significant improvement of both %GFR and T 1/2 (P<0.02 and <0.04 respectively) Regional evaluation of the stone bearing zones revealed transient significant deterioration of their regional ERPF (P<0.03). We found that shocks <3500 caused transient significant improvement of treated side ERPF, whereas >3500 shocks caused the reverse (P<0.05). Moreover, power index (number of shocks X KV) >55000 caused deterioration of their GFR that persisted up to 3 months (P<0.03). Conclusion: ESWL therapy is safe method for treatment of renal stones with no significant functional changes. 6 tabs.

Long-Term Outcome and Quality of Life of Patients With Endometrial Carcinoma Treated With or Without Pelvic Radiotherapy in the Post Operative Radiation Therapy in Endometrial Carcinoma 1 (PORTEC-1) Trial

NARCIS (Netherlands)

Nout, Remi A.; van de Poll-Franse, Lonneke V.; Lybeert, Marnix L. M.; Warlam-Rodenhuis, Carla C.; Jobsen, Jan J.; Mens, Jan Willem M.; Lutgens, Ludy C. H. W.; Pras, Betty; van Putten, Wim L. J.; Creutzberg, Carien L.

2011-01-01

Purpose To determine the long-term outcome and health-related quality of life (HRQL) of patients with endometrial carcinoma (EC) treated with or without pelvic radiotherapy in the Post Operative Radiation Therapy in Endometrial Carcinoma 1 (PORTEC-1) trial. Patients and Methods Between 1990 and

Perturbation training to promote safe independent mobility post-stroke: study protocol for a randomized controlled trial.

Science.gov (United States)

Mansfield, Avril; Aqui, Anthony; Centen, Andrew; Danells, Cynthia J; DePaul, Vincent G; Knorr, Svetlana; Schinkel-Ivy, Alison; Brooks, Dina; Inness, Elizabeth L; McIlroy, William E; Mochizuki, George

2015-06-06

Falls are one of the most common medical complications post-stroke. Physical exercise, particularly exercise that challenges balance, reduces the risk of falls among healthy and frail older adults. However, exercise has not proven effective for preventing falls post-stroke. Falls ultimately occur when an individual fails to recover from a loss of balance. Thus, training to specifically improve reactive balance control could prevent falls. Perturbation training aims to improve reactive balance control by repeatedly exposing participants to postural perturbations. There is emerging evidence that perturbation training reduces fall rates among individuals with neurological conditions, such as Parkinson disease. The primary aim of this work is to determine if perturbation-based balance training can reduce occurrence of falls in daily life among individuals with chronic stroke. Secondary objectives are to determine the effect of perturbation training on balance confidence and activity restriction, and functional balance and mobility. Individuals with chronic stroke will be recruited. Participants will be randomly assigned to one of two groups: 1) perturbation training, or 2) 'traditional' balance training. Perturbation training will involve both manual perturbations (e.g., a push or pull from a physiotherapist), and rapid voluntary movements to cause a loss of balance. Training will occur twice per week for 6 weeks. Participants will record falls and activity for 12 months following completion of the training program. Standardized clinical tools will be used to assess functional balance and mobility, and balance confidence before and after training. Falls are a significant problem for those with stroke. Despite the large body of work demonstrating effective interventions, such as exercise, for preventing falls in other populations, there is little evidence for interventions that prevent falls post-stroke. The proposed study will investigate a novel and promising

A qualitative synthesis of trials promoting physical activity behaviour change among post-treatment breast cancer survivors.

Science.gov (United States)

Short, Camille E; James, Erica L; Stacey, Fiona; Plotnikoff, Ronald C

2013-12-01

Health outcome trials have provided strong evidence that participating in regular physical activity can improve the quality of life and health of post-treatment breast cancer survivors. Focus is now needed on how to promote changes in physical activity behaviour among this group. This systematic review examines the efficacy of behavioural interventions for promoting physical activity among post-treatment breast cancer survivors. Behavioural intervention studies published up until July 2012 were identified through a systematic search of two databases: MEDLINE and CINAHL, and by searching reference lists of relevant publications and scanning citation libraries of project staff. Eight out of the ten identified studies reported positive intervention effects on aerobic physical activity behaviour, ranging from during the intervention period to 6 months post-intervention. Only two studies reported intervention effect sizes. The identification of factors related to efficacy was not possible because of the limited number and heterogeneity of studies included, as well as the lack of effect sizes reported. Nonetheless, an examination of the eight studies that did yield significant intervention effects suggests that 12-week interventions employing behaviour change techniques (e.g., self-monitoring and goal setting) derived from a variety of theories and delivered in a variety of settings (i.e., one-on-one, group or home) can be effective at changing the aerobic physical activity behaviour of breast cancer survivors in the mid- to long terms. Behavioural interventions do hold promise for effectively changing physical activity behaviour among breast cancer survivors. However, future research is needed to address the lack of studies exploring long-term intervention effects, mediators of intervention effects and interventions promoting resistance-training activity, and to address issues impacting on validity, such as the limited use of objective physical activity measures and

Endorphin mediation of post-ictal effects of kindled seizures in rats.

Science.gov (United States)

Kelsey, J E; Belluzzi, J D

1982-12-16

Brief electrical stimulation of the enkephalin-rich globus pallidus at 1-h intervals produced kindled, clonic seizures in rats as rapidly as similar stimulation of the amygdala. Massing the kindling trials at 10-min intervals inhibited the occurrence of subsequent seizures, especially following globus pallidus stimulation. Naloxone (20 mg/kg), an opiate receptor antagonist, reversed this post-ictal inhibition of seizures following massed trials, but had no effect on seizures kindled at 1-h intervals. Thus, endorphin-released during seizures do not appear to mediate the production of kindled seizures, but do appear to mediate the transient posts ictal inhibition of seizures.

Competency to stand trial evaluations: a study of actual practice in two states.

Science.gov (United States)

Robbins, E; Waters, J; Herbert, P

1997-01-01

A criminal defendant must be competent to stand trial (CST) to safeguard the fundamental right to a fair trial. If there is a question as to a defendant's ability to assist in his or her own defense, a mental health professional is asked to perform a CST evaluation. Forensic assessment is a growing field, and CST is the most frequent evaluation requested. Over the years, forensic examiners' reports to the courts have been criticized for lack of relevance, insufficiency, and invading the province of the judge. If mental health professionals wish to advance the field of forensic assessment and respond to these criticisms, research on current practice with suggestions for advancement are necessary. A total of 66 CST reports conducted within the last five years in two states were compared to a proposed model for CST assessment. Results indicated that although forensic examiners are maintaining legal relevance, some CST reports may lack thoroughness and/or provide information that exceeds their role responsibilities. The findings support the need for the development of a standardized method of conducting and writing CST evaluations that should improve the quality of such reports.

Evaluation of stratification factors and score-scales in clinical trials of treatment of clinical mastitis in dairy cows.

Science.gov (United States)

Hektoen, L; Ødegaard, S A; Løken, T; Larsen, S

2004-05-01

There is often a need to reduce sample size in clinical trials due to practical limitations and ethical considerations. Better comparability between treatment groups by use of stratification in the design, and use of continuous outcome variables in the evaluation of treatment results, are two methods that can be used in order to achieve this. In this paper the choice of stratification factors in trials of clinical mastitis in dairy cows is investigated, and two score-scales for evaluation of clinical mastitis are introduced. The outcome in 57 dairy cows suffering from clinical mastitis and included in a clinical trial comparing homeopathic treatment, placebo and a standard antibiotic treatment is investigated. The strata of various stratification factors are compared across treatments to determine which other factors influence outcome. The two score scales, measuring acute and chronic mastitis symptoms, respectively, are evaluated on their ability to differentiate between patients classified from clinical criteria as responders or non-responders to treatment. Differences were found between the strata of the factors severity of mastitis, lactation number, previous mastitis this lactation and bacteriological findings. These factors influence outcome of treatment and appear relevant as stratification factors in mastitis trials. Both score scales differentiated between responders and non-responders to treatment and were found useful for evaluation of mastitis and mastitis treatment.

The Impact of Post-Procedural Asymmetry, Expansion, and Eccentricity of Bioresorbable Everolimus-Eluting Scaffold and Metallic Everolimus-Eluting Stent on Clinical Outcomes in the ABSORB II Trial.

Science.gov (United States)

Suwannasom, Pannipa; Sotomi, Yohei; Ishibashi, Yuki; Cavalcante, Rafael; Albuquerque, Felipe N; Macaya, Carlos; Ormiston, John A; Hill, Jonathan; Lang, Irene M; Egred, Mohaned; Fajadet, Jean; Lesiak, Maciej; Tijssen, Jan G; Wykrzykowska, Joanna J; de Winter, Robbert J; Chevalier, Bernard; Serruys, Patrick W; Onuma, Yoshinobu

2016-06-27

The study sought to investigate the relationship between post-procedural asymmetry, expansion, and eccentricity indices of metallic everolimus-eluting stent (EES) and bioresorbable vascular scaffold (BVS) and their respective impact on clinical events at 1-year follow-up. Mechanical properties of a fully BVS are inherently different from those of permanent metallic stent. The ABSORB II (A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions) trial compared the BVS and metallic EES in the treatment of a de novo coronary artery stenosis. Protocol-mandated intravascular ultrasound imaging was performed pre- and post-procedure in 470 patients (162 metallic EES and 308 BVS). Asymmetry index (AI) was calculated per lesion as: (1 - minimum scaffold/stent diameter/maximum scaffold/stent diameter). Expansion index and optimal scaffold/stent expansion followed the definition of the MUSIC (Multicenter Ultrasound Stenting in Coronaries) study. Eccentricity index (EI) was calculated as the ratio of minimum and maximum scaffold/stent diameter per cross section. The incidence of device-oriented composite endpoint (DoCE) was collected. Post-procedure, the metallic EES group was more symmetric and concentric than the BVS group. Only 8.0% of the BVS arm and 20.0% of the metallic EES arm achieved optimal scaffold/stent expansion (p 0.30 is an independent predictor of DoCE (hazard ratio: 3.43; 95% confidence interval: 1.08 to 10.92; p = 0.037). BVS implantation is more frequently associated with post-procedural asymmetric and eccentric morphology compared to metallic EES. Post-procedural devices asymmetry were independently associated with DoCE following percutaneous coronary intervention. However, this approach should be viewed as hypothesis generating due to low event rates. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281). Copyright © 2016 American

Combined Interval Training and Post-exercise Nutrition in Type 2 Diabetes: A Randomized Control Trial.

Science.gov (United States)

Francois, Monique E; Durrer, Cody; Pistawka, Kevin J; Halperin, Frank A; Chang, Courtney; Little, Jonathan P

2017-01-01

Background: High-intensity interval training (HIIT) can improve several aspects of cardiometabolic health. Previous studies have suggested that adaptations to exercise training can be augmented with post-exercise milk or protein consumption, but whether this nutritional strategy can impact the cardiometabolic adaptations to HIIT in type 2 diabetes is unknown. Objective: To determine if the addition of a post-exercise milk or protein beverage to a high-intensity interval training (HIIT) intervention improves cardiometabolic health in individuals with type 2 diabetes. Design: In a proof-of-concept, double-blind clinical trial 53 adults with uncomplicated type 2 diabetes were randomized to one of three nutritional beverages (500 mL skim-milk, macronutrient control, or flavored water placebo) consumed after exercise (3 days/week) during a 12 week low-volume HIIT intervention. HIIT involved 10 X 1-min high-intensity intervals separated by 1-min low-intensity recovery periods. Two sessions per week were cardio-based (at ~90% of heart rate max) and one session involved resistance-based exercises (at RPE of 5-6; CR-10 scale) in the same interval pattern. Continuous glucose monitoring (CGM), glycosylated hemoglobin (HbA 1c ), body composition (dual-energy X-ray absorptiometry), cardiorespiratory fitness ([Formula: see text]), blood pressure, and endothelial function (%FMD) were measured before and after the intervention. Results: There were significant main effects of time (all p 0.71) for CGM 24-h mean glucose (-0.5 ± 1.1 mmol/L), HbA 1c (-0.2 ± 0.4%), percent body fat (-0.8 ± 1.6%), and lean mass (+1.1 ± 2.8 kg). Similarly, [Formula: see text] (+2.5 ± 1.6 mL/kg/min) and %FMD (+1.4 ± 1.9%) were increased, and mean arterial blood pressure reduced (-6 ± 7 mmHg), after 12 weeks of HIIT (all p 0.11). Conclusion: High-intensity interval training is a potent stimulus for improving several important metabolic and cardiovascular risk factors in type 2 diabetes. The benefits

Prevention and treatment of long-term social disability amongst young people with emerging severe mental illness with social recovery therapy (The PRODIGY Trial): study protocol for a randomised controlled trial.

Science.gov (United States)

Fowler, David; French, Paul; Banerjee, Robin; Barton, Garry; Berry, Clio; Byrne, Rory; Clarke, Timothy; Fraser, Rick; Gee, Brioney; Greenwood, Kathryn; Notley, Caitlin; Parker, Sophie; Shepstone, Lee; Wilson, Jon; Yung, Alison R; Hodgekins, Joanne

2017-07-11

Young people who have social disability associated with severe and complex mental health problems are an important group in need of early intervention. Their problems often date back to childhood and become chronic at an early age. Without intervention, the long-term prognosis is often poor and the economic costs very large. There is a major gap in the provision of evidence-based interventions for this group, and therefore new approaches to detection and intervention are needed. This trial provides a definitive evaluation of a new approach to early intervention with young people with social disability and severe and complex mental health problems using social recovery therapy (SRT) over a period of 9 months to improve mental health and social recovery outcomes. This is a pragmatic, multi-centre, single blind, superiority randomised controlled trial. It is conducted in three sites in the UK: Sussex, Manchester and East Anglia. Participants are aged 16 to 25 and have both persistent and severe social disability (defined as engaged in less than 30 hours per week of structured activity) and severe and complex mental health problems. The target sample size is 270 participants, providing 135 participants in each trial arm. Participants are randomised 1:1 using a web-based randomisation system and allocated to either SRT plus optimised treatment as usual (enhanced standard care) or enhanced standard care alone. The primary outcome is time use, namely hours spent in structured activity per week at 15 months post-randomisation. Secondary outcomes assess typical mental health problems of the group, including subthreshold psychotic symptoms, negative symptoms, depression and anxiety. Time use, secondary outcomes and health economic measures are assessed at 9, 15 and 24 months post-randomisation. This definitive trial will be the first to evaluate a novel psychological treatment for social disability and mental health problems in young people presenting with social

The radiological evaluation of a prototype posting-in hatch under conditions of high alpha activity

International Nuclear Information System (INIS)

Smith, D.I.; Hollick, R.C.

1987-07-01

A prototype posting-in hatch, mounted vertically in the top panel of a highly active glovebox has been radiologically evaluated in the Fuels Laboratory, AEEW. This simple, air-lock type system of 100 mm diameter has pneumatically operated and interlocked lids and a low velocity, inward purge, supplied by the glovebox depression. The hatch proved extremely reliable and very easy to operate. More than 1200 simulated posting movements were carried out and a > 8 order of magnitude reduction in aerosol concentration was recorded from the active glovebox to the monitoring environment. (author)

Process evaluation of the Data-driven Quality Improvement in Primary Care (DQIP) trial: case study evaluation of adoption and maintenance of a complex intervention to reduce high-risk primary care prescribing.

Science.gov (United States)

Grant, Aileen; Dreischulte, Tobias; Guthrie, Bruce

2017-03-10

To explore how different practices responded to the Data-driven Quality Improvement in Primary Care (DQIP) intervention in terms of their adoption of the work, reorganisation to deliver the intended change in care to patients, and whether implementation was sustained over time. Mixed-methods parallel process evaluation of a cluster trial, reporting the comparative case study of purposively selected practices. Ten (30%) primary care practices participating in the trial from Scotland, UK. Four practices were sampled because they had large rapid reductions in targeted prescribing. They all had internal agreement that the topic mattered, made early plans to implement including assigning responsibility for work and regularly evaluated progress. However, how they internally organised the work varied. Six practices were sampled because they had initial implementation failure. Implementation failure occurred at different stages depending on practice context, including internal disagreement about whether the work was worthwhile, and intention but lack of capacity to implement or sustain implementation due to unfilled posts or sickness. Practice context was not fixed, and most practices with initial failed implementation adapted to deliver at least some elements. All interviewed participants valued the intervention because it was an innovative way to address on an important aspect of safety (although one of the non-interviewed general practitioners in one practice disagreed with this). Participants felt that reviewing existing prescribing did influence their future initiation of targeted drugs, but raised concerns about sustainability. Variation in implementation and effectiveness was associated with differences in how practices valued, engaged with and sustained the work required. Initial implementation failure varied with practice context, but was not static, with most practices at least partially implementing by the end of the trial. Practices organised their delivery of

Stomach: ultrasonography evaluation and post mortem inspection in adult horses

Directory of Open Access Journals (Sweden)

Cristiano Chaves Pessoa da Veiga

2014-06-01

Full Text Available ABSTRACT. Veiga C.C.P., Cascon C.M., Souza B.G., Braga L.S.M., Souza V.C., Ferreira A.M.R. & Leite J.S. [Stomach: ultrasonography evaluation and post mortem inspection in adult horses.] Avaliação ultrassonográfica e anatomopatológica macroscópica do estômago de equinos destinados ao abate comercial. Revista Brasileira de Medicina Veterinária, 36(2:125-130, 2014. Instituto de Veterinária, Universidade Federal Rural do Rio de Janeiro, BR 465, km 7, Seropédica, 23890-000, RJ, Brasil. E-mail: radiovet@ufrrj.br The equine gastric ulcer syndrome (EGUS includes all symptomatic or asymptomatic cases of erosions, ulcers, gastritis, gastric emptying disorders, duodenitis, duodenal ulcers and complications of these disorders. Occupies a prominent place in the equine clinic where you can go for the death of the animal. Ultrasonography of the stomach is indicated when the animals showed clinical signs of gastric disease. The aim of this study was to describe the sonographic evaluation and macroscopic pathological findings of the stomach of adult horses intended for commercial slaughter. To this 39 intended for commercial slaughter horses were evaluated. Sonographic evaluation before slaughter transabdominal via the left side of abdomen for evaluation of the stomach was performed. After the slaughter of these animals their stomachs were collected, evaluated and photographed. The study concluded that ultrasonography identified the stomach in all animals evaluated, but did not allow a careful evaluation of the entire length of the viscera, especially the aglandular region and pleated border. All animals evaluated had injury to the gastric mucosa in different degrees. In animals evaluated, the stomach region was most affected by injuries glandular region, although the most severe lesions have been found in the ruffled border adjacent to aglandular region.

Lavender-thymol as a new topical aromatherapy preparation for episiotomy: A randomised clinical trial.

Science.gov (United States)

Marzouk, T; Barakat, R; Ragab, A; Badria, F; Badawy, A

2015-01-01

The objective of this study was to evaluate the effectiveness of topical lavender-thymol in promoting episiotomy healing. This placebo-controlled, single-blinded, randomised clinical trial involved 60 primiparous women. REEDA score was used to evaluate the outcome of the trial. On the 7th post-partum day, women in Placebo-treated group had worse Redness, Edema, Ecchymosis, Discharge and Approximation (REEDA) score of 3.93 ± 3.65 compared with those in Lavender-thymol-treated group (2.03 ± 1.7) with significant difference (P = 0.013). Visual analogue Scale (VAS) score for pain at episiotomy in Lavender-thymol-treated group was 3.5 ± 1.9, whereas in Placebo-treated group it was 2.1 ± 2.2 (p = 0.011) for dyschezia, 3.8 ± 1.7 and 2.8 ± 1.6 in Placebo- and Lavender-thymol-treated women, respectively (p = 0.023). At 7th post-partum week, dyspareunia was more severe in Placebo-treated group compared with that in Lavender-thymol-treated group (5.3 ± 2.7 vs 2.7 ± 1.5 and p aromatherapy using lavender-thymol was highly effective, suitable and safe for episiotomy wound care with little or no expected side effects compared with that using placebo.

Evaluation of eligibility and recruitment in breast cancer clinical trials.

Science.gov (United States)

Lemieux, Julie; Forget, Geneviève; Brochu, Olyvia; Provencher, Louise; Cantin, Guy; Desbiens, Christine; Doyle, Catherine; Poirier, Brigitte; Camden, Stéphanie; Durocher, Martin

2014-08-01

Objectives of the study were to measure recruitment rates in clinical trials and to identify patients, physicians or trials characteristics associated with higher recruitment rates. Among patients who had a clinical trial available for their cancer, 83.5% (345/413) met the eligibility criteria to at least one clinical trial. At least one trial was proposed to 33.1% (113/341) of the eligible patients and 19.7% (68/345) were recruited. Overall recruitment was 16.5% (68/413). In multivariate analyses, trial proposal and enrollment were lower for elderly patients and higher in high cancer stages. Trials from pharmaceutical industry had higher recruitment rates and trials testing hormonal therapy enrolled more patients. Breast cancer patients' accrual to a clinical trial could be improved by trying to systematically identify all eligible patients and propose a trial to those eligible and to whom the treatment is planned to be equivalent to the standard arm of the trial. Copyright © 2014 Elsevier Ltd. All rights reserved.

Post-operative rounds by anaesthesiologists after hip fracture surgery: a pilot study

DEFF Research Database (Denmark)

Foss, Nicolai Bang; Christensen, Dorte Stig; Krasheninnikoff, Michael

2006-01-01

BACKGROUND: Efforts to optimize the peri-operative care of hip fracture patients through multidisciplinary intervention have focused on orthopaedic-geriatric liaisons, which have not resulted in significant outcome changes. The early phase of rehabilitation could potentially be optimized through...... a multidisciplinary effort between anaesthesiologists and orthopaedic surgeons. METHODS: During the first 25 weeks of 2004, 98 consecutive community-residing patients admitted to a hip fracture unit received daily rounds by anaesthesiologists during the first four post-operative days, on weekdays only, focusing...... conditions. CONCLUSION: This pilot study, with insufficient power to show significant differences in outcome, supports further evaluation of the concept of intensified orthopaedic-anaesthesiological co-operation after hip fracture surgery. Such a randomized trial should evaluate economic and clinical outcome...

Evaluation and validation of social and psychological markers in randomised trials of complex interventions in mental health: a methodological research programme.

Science.gov (United States)

Dunn, Graham; Emsley, Richard; Liu, Hanhua; Landau, Sabine; Green, Jonathan; White, Ian; Pickles, Andrew

2015-11-01

The development of the capability and capacity to evaluate the outcomes of trials of complex interventions is a key priority of the National Institute for Health Research (NIHR) and the Medical Research Council (MRC). The evaluation of complex treatment programmes for mental illness (e.g. cognitive-behavioural therapy for depression or psychosis) not only is a vital component of this research in its own right but also provides a well-established model for the evaluation of complex interventions in other clinical areas. In the context of efficacy and mechanism evaluation (EME) there is a particular need for robust methods for making valid causal inference in explanatory analyses of the mechanisms of treatment-induced change in clinical outcomes in randomised clinical trials. The key objective was to produce statistical methods to enable trial investigators to make valid causal inferences about the mechanisms of treatment-induced change in these clinical outcomes. The primary objective of this report is to disseminate this methodology, aiming specifically at trial practitioners. The three components of the research were (1) the extension of instrumental variable (IV) methods to latent growth curve models and growth mixture models for repeated-measures data; (2) the development of designs and regression methods for parallel trials; and (3) the evaluation of the sensitivity/robustness of findings to the assumptions necessary for model identifiability. We illustrate our methods with applications from psychological and psychosocial intervention trials, keeping the technical details to a minimum, leaving the reporting of the more theoretical and mathematically demanding results for publication in appropriate specialist journals. We show how to estimate treatment effects and introduce methods for EME. We explain the use of IV methods and principal stratification to evaluate the role of putative treatment effect mediators and therapeutic process measures. These results are

Evaluation of the Prevention and Reactivation Care Program (PReCaP for the hospitalized elderly: a prospective nonrandomized controlled trial

Directory of Open Access Journals (Sweden)

Asmus-Szepesi KJ

2015-03-01

Full Text Available Kirsten J Asmus-Szepesi,1 Linda E Flinterman,1 Marc A Koopmanschap,2 Anna P Nieboer,2 Ton J Bakker,3 Johan P Mackenbach,1 Ewout W Steyerberg1 1Department of Public Health, Erasmus University Medical Center, 2Institute of Health Policy and Management, Erasmus University, 3Stichting Wetenschap Balans, Rotterdam, the Netherlands Background: The hospitalized elderly are at risk of functional decline. We evaluated the effects and care costs of a specialized geriatric rehabilitation program aimed at preventing functional decline among at-risk hospitalized elderly.Methods: The prospective nonrandomized controlled trial reported here was performed in three hospitals in the Netherlands. One hospital implemented the Prevention and Reactivation Care Program (PReCaP, while two other hospitals providing usual care served as control settings. Within the PReCaP hospital we compared patients pre-implementation with patients post-implementation of the PReCaP (“within-hospital analysis”, while our nonrandomized controlled trial compared patients of the PReCaP hospital post-implementation with patients from the two control hospitals providing usual care (“between-hospital analysis”. Hospitalized patients 65 years or older and at risk of functional decline were interviewed at baseline and at 3 and 12 months using validated questionnaires to score functioning, depression, and health-related quality of life (HRQoL. We estimated costs per unit of care from hospital information systems and national data sources. We used adjusted general linear mixed models to analyze functioning and HRQoL.Results: Between-hospital analysis showed no difference in activities of daily living (ADL or instrumental activities of daily living (IADL between PReCaP patients and control groups. PReCaP patients did have slightly better cognitive functioning (Mini Mental State Examination; 0.4 [95% confidence interval (CI 0.2–0.6], lower depression (Geriatric Depression Scale 15; -0

Identifying MRI markers to evaluate early treatment-related changes post-laser ablation for cancer pain management

Science.gov (United States)

Tiwari, Pallavi; Danish, Shabbar; Madabhushi, Anant

2014-03-01

Laser interstitial thermal therapy (LITT) has recently emerged as a new treatment modality for cancer pain management that targets the cingulum (pain center in the brain), and has shown promise over radio-frequency (RF) based ablation which is reported to provide temporary relief. One of the major advantages enjoyed by LITT is its compatibility with magnetic resonance imaging (MRI), allowing for high resolution in vivo imaging to be used in LITT procedures. Since laser ablation for pain management is currently exploratory and is only performed at a few centers worldwide, its short-, and long-term effects on the cingulum are currently unknown. Traditionally treatment effects are evaluated by monitoring changes in volume of the ablation zone post-treatment. However, this is sub-optimal since it involves evaluating a single global parameter (volume) to detect changes pre-, and post-MRI. Additionally, the qualitative observations of LITT-related changes on multi-parametric MRI (MPMRI) do not specifically address differentiation between the appearance of treatment related changes (edema, necrosis) from recurrence of the disease (pain recurrence). In this work, we explore the utility of computer extracted texture descriptors on MP-MRI to capture early treatment related changes on a per-voxel basis by extracting quantitative relationships that may allow for an in-depth understanding of tissue response to LITT on MRI, subtle changes that may not be appreciable on original MR intensities. The second objective of this work is to investigate the efficacy of different MRI protocols in accurately capturing treatment related changes within and outside the ablation zone post-LITT. A retrospective cohort of studies comprising pre- and 24-hour post-LITT 3 Tesla T1-weighted (T1w), T2w, T2-GRE, and T2-FLAIR acquisitions was considered. Our scheme involved (1) inter-protocol as well as inter-acquisition affine registration of pre- and post-LITT MRI, (2) quantitation of MRI parameters

History of early abuse as a predictor of treatment response in patients with fibromyalgia : A post-hoc analysis of a 12-week, randomized, double-blind, placebo-controlled trial of paroxetine controlled release

NARCIS (Netherlands)

Pae, Chi-Un; Masand, Prakash S.; Marks, David M.; Krulewicz, Stan; Han, Changsu; Peindl, Kathleen; Mannelli, Paolo; Patkar, Ashwin A.

2009-01-01

Objectives. We conducted a post-hoc analysis to determine whether a history of physical or sexual abuse was associated with response to treatment in a double-blind, randomized, placebo-controlled trial of paroxetine controlled release (CR) in fibromyalgia. Methods. A randomized, double-blind,

Adjuvant post-operative radiotherapy vs radiotherapy plus 5-FU and levamisole in patients with TNM stage II-III resectable rectal cancer. A phase III randomized clinical trial

Energy Technology Data Exchange (ETDEWEB)

Cafiero, F.; Gipponi, M.; Di Somma, C. [Istituto Nazionale per la Ricerca sul Cancro, Geneo (Italy). Istituto di Oncologia Clinica] [and others

1995-08-01

Loco-regional and distant relapses contribute to impair the outcome of rectal cancer patients. As to the former, either pre-or post-operative radiation therapy (RT) significantly reduce loco-regional recurrence; post-operative chemotherapy (CT), alone or in different combinations with RT, is effective in improving both disease-free survival and survival. However, many drawbacks still exist regarding the method of RT delivery as well as the toxicity of combination adjuvant chemotherapy. The aim of this trial is to assess the effectiveness and toxicity of adjuvant post-operative RT vs combined RT and CT (5-FU plus levamisole) in patients with TNM stage II-III resectable rectal cancer (pT3-4, pN0, M0; pT1-4, pN1-3, M0). The primary endpoint is overall survival; secondary endpoints are disease-free survival rate of loco-regional recurrence, and treatment-related toxicity/morbidity. (author).

Effectiveness of proactive telephone counselling for smoking cessation in parents: Study protocol of a randomized controlled trial

Directory of Open Access Journals (Sweden)

Bricker Jonathan B

2011-09-01

Full Text Available Abstract Background Smoking is the world's fourth most common risk factor for disease, the leading preventable cause of death, and it is associated with tremendous social costs. In the Netherlands, the smoking prevalence rate is high. A total of 27.7% of the population over age 15 years smokes. In addition to the direct advantages of smoking cessation for the smoker, parents who quit smoking may also decrease their children's risk of smoking initiation. Methods/Design A randomized controlled trial will be conducted to evaluate the effectiveness of proactive telephone counselling to increase smoking cessation rates among smoking parents. A total of 512 smoking parents will be proactively recruited through their children's primary schools and randomly assigned to either proactive telephone counselling or a control condition. Proactive telephone counselling will consist of up to seven counsellor-initiated telephone calls (based on cognitive-behavioural skill building and Motivational Interviewing, distributed over a period of three months. Three supplementary brochures will also be provided. In the control condition, parents will receive a standard brochure to aid smoking cessation. Assessments will take place at baseline, three months after start of the intervention (post-measurement, and twelve months after start of the intervention (follow-up measurement. Primary outcome measures will include sustained abstinence between post-measurement and follow-up measurement and 7-day point prevalence abstinence and 24-hours point prevalence abstinence at both post- and follow-up measurement. Several secondary outcome measures will also be included (e.g., smoking intensity, smoking policies at home. In addition, we will evaluate smoking-related cognitions (e.g., attitudes towards smoking, social norms, self-efficacy, intention to smoke in 9-12 year old children of smoking parents. Discussion This study protocol describes the design of a randomized

Randomized clinical trial of post-operative radiotherapy versus concomitant carboplatin and radiotherapy for head and neck cancers with lymph node involvement

International Nuclear Information System (INIS)

Racadot, Severine; Mercier, Mariette; Dussart, Sophie; Dessard-Diana, Bernadette; Bensadoun, Rene-Jean; Martin, Michel; Malaurie, Emmanuelle; Favrel, Veronique; Housset, Martin; Durdux, Catherine; Journel, Catherine; Calais, Gilles; Huet, Jocelyne; Pillet, Gerard; Hennequin, Christophe; Haddad, Elias; Diana, Christian; Blaska-Jaulerry, Brigitte; Henry-Amar, Michel; Gehanno, Pierre

2008-01-01

Background and purpose: Post-operative radiotherapy is indicated for the treatment of head and neck cancers. In vitro, chemotherapy potentiates the cytotoxic effects of radiation. We report the results of a randomized trial testing post-operative radiotherapy alone versus concomitant carboplatin and radiotherapy for head and neck cancers with lymph node involvement. Materials and methods: The study involved patients undergoing curative-intent surgery for head and neck cancers with histological evidence of lymph node involvement. Patients were randomly assigned to receive radiotherapy alone (54-72 Gy, 30-40 fractions, 6-8 weeks) or identical treatment plus concomitant Carboplatin (50 mg/m 2 administered by IV infusion twice weekly). Results: Between February 1994 and June 2002, 144 patients were included. With a median follow-up of 106 months (95% confidence interval (CI) [92-119]), the 2-year rate of loco-regional control was 73% (95% CI: 0.61-0.84) in the combined treatment group and 68% (95% CI: 0.57-0.80) in the radiotherapy group (p = 0.26). Overall survival did not differ significantly between groups (hazard ratio for death, 1.05; 95% CI: 0.69-1.60; p = 0.81). Conclusions: Twice-weekly administration of carboplatin concomitant to post-operative radiotherapy did not improve local control or overall survival rates in this population of patients with node-positive head and neck cancers

Evaluation of ketorolac compared to ketorolac plus dipyrone in post-operative analgesia of videolaparoscopic cholecystectomy

Directory of Open Access Journals (Sweden)

Silvia Katlauskas Muraro

2009-03-01

Full Text Available Objectives: To compare the analgesic effect of ketorolac with the association of ketorolac plus dipyrone after videolaparoscpic cholecystectomy and with a placebo group. Methods: After approval by the Research Ethics Committee and after having the informed consent signed, 60 patients aged between 18 and 60 years who underwent videolaparoscopic cholecystectomy were evaluated for the post-operative analgesia provided by ketorolac compared to ketorolac plus dipyrone. The patients underwent general anesthesia (with propofol, alfentanil, rocuronium and maintenance with isoflurane. Twenty patients received 20 ml water, 20 patients received ketorolac 30 mg in 20 ml water and 20 received ketorolac 30 mg plus dipyrone 2 g in 20 ml water, during anesthetic induction. In the post-operative recovery room, the patients were evaluated to the moment of their first pain complaint with the use of a visual analogue scale and a verbal pain scale every hour in the first six hours. When necessary, morphine was administered as a rescue medication for pain relief and a PCA pump with morphine solution was turned on. Rresults: Total morphine use was lower in the ketorolac plus dipyrone Group (2 mg and in the ketorolac (2 mg Group, compared to the placebo Group (10.5 mg. Of 20 cases of ketorolac plus dipyrone, eight patients did not complain of pain in the post-operative period, while only three patients did not complain in the ketorolac Group and in the placebo Group (p = 0,05. Cconclusion: Ketorolac is a potent analgesic agent widely used for acute pain treatment, especially after surgeries, with an analgesic potency comparable to that of opiates, the most commonly drugs used during the post-operative of medium to major surgeries. In this study, the results analyzed at this moment show that the association of ketorolac plus dipyrone seemed to be superior to post-operative analgesia compared to the use of ketorolac.

The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial.

Science.gov (United States)

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.

Ex-post evaluation. Research independency of the basic science study of JAERI

International Nuclear Information System (INIS)

Yanagisawa, Kazuaki; Takahashi, Shoji

2010-06-01

A research independency was defined here as the continuity and the development of a corresponding research field with an evolution of history. The authors took three fields as research parameters for the ex-post evaluation. They were all belonged to the basic science field studied in the Japan Atomic Energy Research Institute (JAERI). The first parameter was actinides, which was situated in the center of research networking from the viewpoint of socio-economy. The second parameter was positron, which was situated in the periphery of research networking and the third one was neutron, which had competition with other research organizations in Japan. The three were supported and promoted financially by the JAERI. The target year was covered from 1978 to 2002, a 25-years. INIS (International Nuclear Information Systems) operated by the International Atomic Energy Agency (IAEA) was used as the tool for the present bibliometric study. It was revealed that important factors that led the sustainable success of the research independency were the constant efforts to accomplish their mission, the education of their successors to instructing the explicit and tacit research findings and the construction of intellectual networking with learned circles and industries, those were in good collaboration with JAERI. These were quantitatively clarified. Conversely, main factors that impeded the development of the research independency were discontinuance of research caused by a retirement, a change of post or that of occupation, and an unexpected accident (death) of the core researchers. Among three parameters, the authors confirmed that there occurred the time-dependent stage of germination, development and declination of the research independency attributing to the interaction between the succession factors and impeded factors. For this kind of ex-post evaluation, the support of field research laboratory was inevitable. (author)

The Psychosocial and Independent Living Donor Advocate Evaluation and Post-surgery Care of Living Donors.

Science.gov (United States)

Rudow, Dianne LaPointe; Swartz, Kathleen; Phillips, Chelsea; Hollenberger, Jennifer; Smith, Taylor; Steel, Jennifer L

2015-09-01

Solid organ transplantation as a treatment for end stage organ failure has been an accepted treatment option for decades. Despite advances in medicine and technology, and increased awareness of organ donation and transplantation, the gap between supply and demand continues to widen. Living donation has been an option that has increased the number of transplants despite the continued shortage of deceased organs. In the early 2000s live donor transplantation reached an all-time high in the United States. As a result, a consensus meeting was convened in 2000 to increase the oversight of living donor transplantation. Both the Centers for Medicare and Medicaid Services and the United Network for Organ Sharing developed regulations that transplant programs performing live donor transplantation. These regulations and guidelines involve the education, evaluation, informed consent process and living donor follow-up care. Two areas in which had significant changes included the psychosocial and the independent living donor advocate (ILDA) evaluation. The purpose of this paper was to outline the current regulations and guidelines associated with the psychosocial and ILDA evaluation as well as provide further recommendations for the administration of a high quality evaluation of living donors. The goals and timing of the evaluation and education of donors; qualifications of the health care providers performing the evaluation; components of the evaluation; education provided to donors; documentation of the evaluation; participation in the selection committee meeting; post-decline and post-donation care of donors is described. Caveats including the paired donor exchange programs and non-directed and directed donation are also considered.

Evaluation of the trial design studies for an advanced marine reactor, (2)

International Nuclear Information System (INIS)

Ambo, Noriaki; Yokomura, Takeyoshi.

1988-03-01

As for the CARAMEL fuel (plate-type fuel) that was the fuel of the integrated-type reactor which was one of the trial design studies for an Advanced Marine Reactor, its structure and its fuel specific characteristics were studied and compared with a fuel rod (cylindrical fuel), and the total characteristics of the caramel fuel was reviewed and evaluated. (author)

POLICY IMPLICATIONS OF ADJUSTING RANDOMIZED TRIAL DATA FOR ECONOMIC EVALUATIONS: A DEMONSTRATION FROM THE ASCUS-LSIL TRIAGE STUDY

Science.gov (United States)

Campos, Nicole G.; Castle, Philip E.; Schiffman, Mark; Kim, Jane J.

2013-01-01

Background Although the randomized controlled trial (RCT) is widely considered the most reliable method for evaluation of health care interventions, challenges to both internal and external validity exist. Thus, the efficacy of an intervention in a trial setting does not necessarily represent the real-world performance that decision makers seek to inform comparative effectiveness studies and economic evaluations. Methods Using data from the ASCUS-LSIL Triage Study (ALTS), we performed a simplified economic evaluation of age-based management strategies to detect cervical intraepithelial neoplasia grade 3 (CIN3) among women who were referred to the study with low-grade squamous intraepithelial lesions (LSIL). We used data from the trial itself to adjust for 1) potential lead time bias and random error that led to variation in the observed prevalence of CIN3 by study arm, and 2) potential ascertainment bias among providers in the most aggressive management arm. Results We found that using unadjusted RCT data may result in counterintuitive cost-effectiveness results when random error and/or bias are present. Following adjustment, the rank order of management strategies changed for two of the three age groups we considered. Conclusion Decision analysts need to examine study design, available trial data and cost-effectiveness results closely in order to detect evidence of potential bias. Adjustment for random error and bias in RCTs may yield different policy conclusions relative to unadjusted trial data. PMID:22147881

Effectiveness of home visits by mental health nurses for Japanese women with post-partum depression.

Science.gov (United States)

Tamaki, Atsuko

2008-12-01

Post-partum depression affects 10-13% of Japanese women, but many do not receive appropriate treatment or support. This intervention study evaluated the effectiveness of home visits by mental health nurses for Japanese women with post-partum depression. Eighteen post-partum women met the inclusion criteria and were randomly allocated into the intervention (n = 9) or control (n = 9) group at 1-2 months after giving birth. The intervention group received four weekly home visits by a mental health nurse. Control group participants received usual care. Two women in the intervention group did not complete the study. Depressive symptoms and quality of life were measured at 1 and 6 weeks' postintervention. In addition, participants completed an open-ended questionnaire on satisfaction and meaning derived from the home visits. Women in the intervention group had significant amelioration of depressive symptoms over time and reported positive benefits from the home visits, but there were no statistically significant differences between groups. Significant differences (P post-partum depression. A larger trial is warranted to test this approach to care.

Type I error probability spending for post-market drug and vaccine safety surveillance with binomial data.

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Silva, Ivair R

2018-01-15

Type I error probability spending functions are commonly used for designing sequential analysis of binomial data in clinical trials, but it is also quickly emerging for near-continuous sequential analysis of post-market drug and vaccine safety surveillance. It is well known that, for clinical trials, when the null hypothesis is not rejected, it is still important to minimize the sample size. Unlike in post-market drug and vaccine safety surveillance, that is not important. In post-market safety surveillance, specially when the surveillance involves identification of potential signals, the meaningful statistical performance measure to be minimized is the expected sample size when the null hypothesis is rejected. The present paper shows that, instead of the convex Type I error spending shape conventionally used in clinical trials, a concave shape is more indicated for post-market drug and vaccine safety surveillance. This is shown for both, continuous and group sequential analysis. Copyright © 2017 John Wiley & Sons, Ltd.

Impact on learning of an e-learning module on leukaemia: a randomised controlled trial

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Morgulis Yuri

2012-05-01

Full Text Available Abstract Background e-learning resources may be beneficial for complex or conceptually difficult topics. Leukaemia is one such topic, yet there are no reports on the efficacy of e-learning for leukaemia. This study compared the learning impact on senior medical students of a purpose-built e-learning module on leukaemia, compared with existing online resources. Methods A randomised controlled trial was performed utilising volunteer senior medical students. Participants were randomly allocated to Study and Control groups. Following a pre-test on leukaemia administered to both groups, the Study group was provided with access to the new e-learning module, while the Control group was directed to existing online resources. A post-test and an evaluation questionnaire were administered to both groups at the end of the trial period. Results Study and Control groups were equivalent in gender distribution, mean academic ability, pre-test performance and time studying leukaemia during the trial. The Study group performed significantly better than the Control group in the post-test, in which the group to which the students had been allocated was the only significant predictor of performance. The Study group’s evaluation of the module was overwhelmingly positive. Conclusions A targeted e-learning module on leukaemia had a significant effect on learning in this cohort, compared with existing online resources. We believe that the interactivity, dialogic feedback and integration with the curriculum offered by the e-learning module contributed to its impact. This has implications for e-learning design in medicine and other disciplines.

Impact on learning of an e-learning module on leukaemia: a randomised controlled trial

Science.gov (United States)

2012-01-01

Background e-learning resources may be beneficial for complex or conceptually difficult topics. Leukaemia is one such topic, yet there are no reports on the efficacy of e-learning for leukaemia. This study compared the learning impact on senior medical students of a purpose-built e-learning module on leukaemia, compared with existing online resources. Methods A randomised controlled trial was performed utilising volunteer senior medical students. Participants were randomly allocated to Study and Control groups. Following a pre-test on leukaemia administered to both groups, the Study group was provided with access to the new e-learning module, while the Control group was directed to existing online resources. A post-test and an evaluation questionnaire were administered to both groups at the end of the trial period. Results Study and Control groups were equivalent in gender distribution, mean academic ability, pre-test performance and time studying leukaemia during the trial. The Study group performed significantly better than the Control group in the post-test, in which the group to which the students had been allocated was the only significant predictor of performance. The Study group’s evaluation of the module was overwhelmingly positive. Conclusions A targeted e-learning module on leukaemia had a significant effect on learning in this cohort, compared with existing online resources. We believe that the interactivity, dialogic feedback and integration with the curriculum offered by the e-learning module contributed to its impact. This has implications for e-learning design in medicine and other disciplines. PMID:22640463

Nupec thermal hydraulic test to evaluate post-DNB characteristics for PWR fuel assemblies (1. general test plan and results)

International Nuclear Information System (INIS)

Norio, Kono; Kenji, Murai; Kaichiro, Misima; Takayuki, Suemura; Yoshiei, Akiyama; Keiichi, Hori

2001-01-01

In the present thermal hydraulic design of Pressurized Water Reactor (PWR), a departure from nucleate boiling (DNB) under anticipated transient conditions is not allowed. However, it is recognized that the DNB dose not cause a fuel rod failure immediately, and a suitable reactor trip can prevent the core from severe damages. If the fuel rod temperature under the post-DNB conditions can be accurately evaluated, the potentially existing margin in the present design method will be quantitatively assessed. To establish the heat transfer evaluation method on post-DNB event for PWR thermal hydraulic design, Nuclear Power Engineering Corporation (NUPEC) started a program, NUPEC Thermal Hydraulic Test to Evaluate Post-DNB Characteristics for PWR Fuel Assemblies (NUPEC-TH-P), in 1995 (hereinafter the year means fiscal year) under the sponsorship of Ministry of Economy, Trade and industry (METI). This program is now under going until 2001. This paper is to show the overall plan and the status of NUPEC-TH-P. (authors)

Randomized controlled evaluation of an early intervention to prevent post-rape psychopathology.

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Resnick, Heidi; Acierno, Ron; Waldrop, Angela E; King, Lynda; King, Daniel; Danielson, Carla; Ruggiero, Kenneth J; Kilpatrick, Dean

2007-10-01

A randomized between-group design was used to evaluate the efficacy of a video intervention to reduce post-traumatic stress disorder (PTSD) and other mental health problems, implemented prior to the forensic medical examination conducted within 72 h post-sexual assault. Participants were 140 female victims of sexual assault (68 video/72 nonvideo) aged 15 years or older. Assessments were targeted for 6 weeks (Time 1) and 6 months (Time 2) post-assault. At Time 1, the intervention was associated with lower scores on measures of PTSD and depression among women with a prior rape history relative to scores among women with a prior rape history in the standard care condition. At Time 2, depression scores were also lower among those with a prior rape history who were in the video relative to the standard care condition. Small effects indicating higher PTSD and Beck Anxiety Inventory (BAI) scores among women without a prior rape history in the video condition were observed at Time 1. Accelerated longitudinal growth curve analysis indicated a videoxprior rape history interaction for PTSD, yielding four patterns of symptom trajectory over time. Women with a prior rape history in the video condition generally maintained the lowest level of symptoms.

Prediction of black box warning by mining patterns of Convergent Focus Shift in clinical trial study populations using linked public data.

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Ma, Handong; Weng, Chunhua

2016-04-01

To link public data resources for predicting post-marketing drug safety label changes by analyzing the Convergent Focus Shift patterns among drug testing trials. We identified 256 top-selling prescription drugs between 2003 and 2013 and divided them into 83 BBW drugs (drugs with at least one black box warning label) and 173 ROBUST drugs (drugs without any black box warning label) based on their FDA black box warning (BBW) records. We retrieved 7499 clinical trials that each had at least one of these drugs for intervention from the ClinicalTrials.gov. We stratified all the trials by pre-marketing or post-marketing status, study phase, and study start date. For each trial, we retrieved drug and disease concepts from clinical trial summaries to model its study population using medParser and SNOMED-CT. Convergent Focus Shift (CFS) pattern was calculated and used to assess the temporal changes in study populations from pre-marketing to post-marketing trials for each drug. Then we selected 68 candidate drugs, 18 with BBW warning and 50 without, that each had at least nine pre-marketing trials and nine post-marketing trials for predictive modeling. A random forest predictive model was developed to predict BBW acquisition incidents based on CFS patterns among these drugs. Pre- and post-marketing trials of BBW and ROBUST drugs were compared to look for their differences in CFS patterns. Among the 18 BBW drugs, we consistently observed that the post-marketing trials focused more on recruiting patients with medical conditions previously unconsidered in the pre-marketing trials. In contrast, among the 50 ROBUST drugs, the post-marketing trials involved a variety of medications for testing their associations with target intervention(s). We found it feasible to predict BBW acquisitions using different CFS patterns between the two groups of drugs. Our random forest predictor achieved an AUC of 0.77. We also demonstrated the feasibility of the predictor for identifying long

Participant recruitment and retention in longitudinal preconception randomized trials: lessons learnt from the Calcium And Pre-eclampsia (CAP) trial.

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Lawrie, Theresa A; Betrán, Ana Pilar; Singata-Madliki, Mandisa; Ciganda, Alvaro; Hofmeyr, G Justus; Belizán, José M; Purnat, Tina Dannemann; Manyame, Sarah; Parker, Catherine; Cormick, Gabriela

2017-10-26

The preconception period has the potential to influence pregnancy outcomes and randomized controlled trials (RCTs) are needed to evaluate a variety of potentially beneficial preconception interventions. However, RCTs commencing before pregnancy have significant participant recruitment and retention challenges. The Calcium And Pre-eclampsia trial (CAP trial) is a World Health Organization multi-country RCT of calcium supplementation commenced before pregnancy to prevent recurrent pre-eclampsia in which non-pregnant participants are recruited and followed up until childbirth. This sub-study explores recruitment methods and preconception retention of participants of the CAP trial to inform future trials. Recruiters at the study sites in Argentina, South Africa and Zimbabwe completed post-recruitment phase questionnaires on recruitment methods used. Qualitative data from these questionnaires and quantitative data on pre-pregnancy trial visit attendance and pregnancy rates up to September 2016 are reported in this paper. RStudio (Version 0.99.903 https://www.rstudio.org ) statistical software was used for summary statistics. Between July 2011 and 8 September 2016, 1354 women with previous pre-eclampsia were recruited. Recruitment took 2 years longer than expected and was facilitated mainly through medical record/register and maternity ward/clinic-based strategies. Recruiters highlighted difficulties associated with inadequate medical records, redundant patient contact details, and follow-up of temporarily ineligible women as some of the challenges faced. Whilst the attendance rates at pre-pregnancy visits were high (78% or more), visits often occurred later than scheduled. Forty-five percent of participants became pregnant (614/1354), 33.5% (454/1354) within 1 year of randomization. In preconception trials, both retrospective and prospective methods are useful for recruiting eligible women with certain conditions. However, these are time-consuming in low

Evaluation of contributing factors of post transplant erythrocytosis in renal transplant patients

International Nuclear Information System (INIS)

Ahmed, S.; Ahmed, E.; Naqvi, R.; Qureshi, S.

2012-01-01

Objective: To evaluate the prevalence and contributing factors causing post transplant erythrocytosis in renal transplant patients. Methods: This retrospective study was conducted on live related renal transplant patients at SIUT. The records of all transplant recipients transplanted between April 2008 and December 2008 and who had at least 24 months follow up were studied. Patients in whom haematocrit exceeded 51% and those who received treatment for it were classified into post transplant erythrocytosis group. Results: Out of 200 renal transplant patients who had functioning graft at the time of analysis, 40 (20%) developed post transplant erythrocytosis (HCT >51%) after a mean interval of 9.5+- 2.5 months. Patients with erythrocytosis were mostly males (95% in PTE group vs 73.75% in non PTE group) ,had a shorter period on dialysis before undergoing renal transplantation (9.28 months in PTE group vs 14.56 months in non PTE group) and had relatively better graft function at the onset of erythrocytosis as judged by serum creatinine (S. Creatinine of 1.06+-0.29 mg/dl in PTE group vs 1.37 +- 0.51 mg/dl in non PTE group). No thrombotic complications were observed. All patients with erythrocytosis were treated with enalapril (ACE inhibitors) and 28 out of 40 required phlebotomy in addition to ACE inhibitors. The mean HCT at the time of last follow up in treated patients was 48.61+-1.85%. Conclusion: Post transplant erythrocytosis generally occurs in male patients with good graft function, thrombotic complications are of rare occurrence and response to ACE inhibitors is good. (author)

Effectiveness of group reminiscence for improving wellbeing of institutionalized elderly adults: study protocol for a randomized controlled trial.

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Gaggioli, Andrea; Scaratti, Chiara; Morganti, Luca; Stramba-Badiale, Marco; Agostoni, Monica; Spatola, Chiara A M; Molinari, Enrico; Cipresso, Pietro; Riva, Giuseppe

2014-10-25

Group reminiscence therapy is a brief and structured intervention in which participants share personal past events with peers. This approach has been shown to be promising for improving wellbeing and reducing depressive symptoms among institutionalized older adults. However, despite the considerable interest in reminiscence group therapy, controlled studies to determine its specific benefits as compared to generic social interactions with peers (group conversations about everyday subjects) are still lacking. We have designed a randomized controlled trial aimed at comparing the effects of group reminiscence therapy with those of group recreational activity on the psychological wellbeing of an institutionalized sample of older adults. The study includes two groups of 20 hospitalized elderly participants: the experimental group and the control group. Participants included in the experimental group will receive six sessions of group reminiscence therapy, while the control group will participate in a recreational group discussion. A repeated-measures design will be used post-intervention and three months post-intervention to evaluate changes in self-reported outcome measures of depressive symptoms, self-esteem, life satisfaction, and quality of life from baseline. The protocol of a study aimed at examining the specific effects of group reminiscence therapy on psychological wellbeing, depression, and quality of life among institutionalized elderly people is described. It is expected that the outcomes of this trial will contribute to our knowledge about the process of group reminiscence, evaluate its effectiveness in improving psychological wellbeing of institutionalized individuals, and identify the best conditions for optimizing this approach. This trial was registered with ClinicalTrials.gov (registration number: NCT02077153) on 31 January 2014.

METHODOLOGICAL APPROACHES TO EXPERT EVALUATION OF PRECLINICAL AND CLINICAL TRIALS OF HUMAN IMMUNOGLOBULIN PRODUCTS

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V. B. Ivanov

2017-01-01

Full Text Available The article considers the experience of Russian and leading foreign regulatory agencies in organisation and conduction of preclinical and clinical trials of human immunoglobulin products. The authors suggest a classification of human immunoglobulins and provide updated information on authorization of these products in Russia. The article summarizes methodological approaches, basic scientific principles and criteria relating to expert evaluation of preclinical and clinical trials of blood products. The authors further define the expert body’s requirements for data on preclinical and clinical trials of human normal immuniglobulins and human specific immunoglobulins for the prevention and/or treatment of infectious and non-infectious diseases which are submitted as part of applications for marketing authorization or marketing authorization variation. The article suggests programs of preclinical and clinical trials for human normal immunoglobulins and human specific immunoglobulins for the prevention and/or treatment of infectious and non-infectious diseases that are aligned with the Russian legislation and Eurasian Economic Union’s regulations on medicines circulation, and have been elaborated with respect to the guidelines of the European Medicines Agency.

Process evaluation of a cluster-randomised trial testing a pressure ulcer prevention care bundle: a mixed-methods study.

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Roberts, Shelley; McInnes, Elizabeth; Bucknall, Tracey; Wallis, Marianne; Banks, Merrilyn; Chaboyer, Wendy

2017-02-13

As pressure ulcers contribute to significant patient burden and increased health care costs, their prevention is a clinical priority. Our team developed and tested a complex intervention, a pressure ulcer prevention care bundle promoting patient participation in care, in a cluster-randomised trial. The UK Medical Research Council recommends process evaluation of complex interventions to provide insight into why they work or fail and how they might be improved. This study aimed to evaluate processes underpinning implementation of the intervention and explore end-users' perceptions of it, in order to give a deeper understanding of its effects. A pre-specified, mixed-methods process evaluation was conducted as an adjunct to the main trial, guided by a framework for process evaluation of cluster-randomised trials. Data was collected across eight Australian hospitals but mainly focused on the four intervention hospitals. Quantitative and qualitative data were collected across the evaluation domains: recruitment, reach, intervention delivery and response to intervention, at both cluster and individual patient level. Quantitative data were analysed using descriptive and inferential statistics. Qualitative data were analysed using thematic analysis. In the context of the main trial, which found a 42% reduction in risk of pressure ulcer with the intervention that was not significant after adjusting for clustering and covariates, this process evaluation provides important insights. Recruitment and reach among clusters and individuals was high, indicating that patients, nurses and hospitals are willing to engage with a pressure ulcer prevention care bundle. Of 799 intervention patients in the trial, 96.7% received the intervention, which took under 10 min to deliver. Patients and nurses accepted the care bundle, recognising benefits to it and describing how it enabled participation in pressure ulcer prevention (PUP) care. This process evaluation found no major failures

COMPARISON BETWEEN POST ISOMETRIC RELAXATION AND RECIPROCAL INHIBITION MANUEVERS ON HAMSTRING FLEXIBILITY IN YOUNG HEALTHY ADULTS: RANDOMIZED CLINICAL TRIAL

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Agrawal Sonal S

2016-01-01

Full Text Available Background & Purpose: Variations in the application of muscle energy technique (MET for increasing the extensibility of muscles have been advocated, but little evidence exists to support the relative merit of a particular approach. This study investigated two types of muscle energy techniques that have been advocated in the osteopathic literature that differ primarily in the muscle group targeted. Aim: To compare the efficacy of Post Isometric Relaxation (PIR and Reciprocal Inhibition (RI on hamstring length in young healthy adults Methodology: Randomized clinical trial 100 college students aged between 18-25 years were included. The subjects were randomly assigned to PIR and RI group. Each group consisted of 50 subjects (25 male, 25 female. Knee extension limitation was measured by using active knee extension test (AKET pre & post-intervention, i.e. after 3 weeks of stretching regimen, with the help of universal full circle goniometer. Results: There was significant improvement in hamstrings flexibility (p=0.000 in both PIR and RI groups. Statistical comparison of the results of both the technique showed that PIR group had greater improvement than the RI group (p=0.000 Conclusion: PIR and RI were both found to be effective in improving hamstring flexibility but, PIR is more effective therapeutic maneuver.

Effect of Cryoanalgesia on Post Midsternotomy Pain and Paresthesia Following CABG

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H Hosseini

2009-07-01

Full Text Available Introduction: Control of post thoracotomy pain is particularly important in prevention of post operative respiratory complications. Several methods are proposed for control of postoperative pain. Cryoanalgesia by freezing of intercostal nerves is able to providing long term pain relief in post operative period which probably results in cutaneous sensory changes. Methods: This clinical trial study was done on 124 patients who underwent CABG surgery. Patients were randomly divided in two groups; control group (group I and study group (group II. In study group cryoanalgesia was applied intraoperatively on the intercostal nerves. All of the patients received appropriate analgesia on demand in postoperative period. Pain in LIMA harvesting site and sternum was measured by visual analogue pain score before discharge, one and three months following cryoanalgesia. In all of the patient’s, presence of paresthesia was evaluated. The amount of administered analgesics (narcotic, opium, indomethacin was noted daily. Data of this investigation was analyzed and evaluated using SPSS 11.5 software. Results: Pain score of sternum was higher in study group before discharge and was lower at one and three months after operation than the control group that was statistically significant (P=0.01. Pain score of LIMA region before discharge was higher, at one month post operation was equal and at three months post operative was lower than the control group (P=0.045. Use of morphine and opium was lower (P=0.017 and use of indomethacin was higher in the cryoanalgesia group that was statistically significant (P=0.001. Incidence of paresthesia was lower in the study group (P=0.001. Conclusion: It is proposed that cryoanalgesia is a safe and effective method for reduction of pain and paresthesia and need for analgesics following CABG operation.

Determinants of continuance intention in a post-adoption satisfaction evaluation of a clinical information system.

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Hadji, Brahim; Dupuis, Isabelle; Leneveut, Laurence; Heudes, Didier; Wagner, Jean-François; Degoulet, Patrice

2014-01-01

The evaluation of end-user satisfaction is an essential part of any clinical information system (CIS) project. The purpose of this study is to evaluate the determinants of CIS continuance intention in a late post-adoption phase at the Georges Pompidou University Hospital (HEGP) in Paris. We designed an electronic survey instrument based on an IT post-adoption model (ITPAM) developed from three previous models, i.e., the Delone and McLean Information Success Model, the Davis TAM model and the Bhattacherjee information system continuance intention model. 419 questionnaires were collected from CIS users directly involved in patient care. The perceived CIS quality, usefulness and user satisfaction are significantly lower for medical professions than other professional groups. Continuance intention is very high within all professional subgroups. In a multiple regression analysis, the global satisfaction (R(2) = .780) was positively and significantly correlated with CIS quality, confirmation of expectations and perceived CIS usefulness. The continuance intention (R(2) = .392) was positively and significantly correlated with perceived CIS usefulness, confirmation of expectations and global satisfaction. In a late post-adoption CIS deployment phase, continuance intention does not significantly depend on individual end user characteristics but is significantly associated with the perceived CIS usefulness, confirmation of expectations and global satisfaction.

[Rehabilitation evaluation on post-stroke abnormal movement pattern prevented and treated with acupuncture and rehabilitation].

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Zhang, Hui-min; Tang, Qiang

2011-06-01

To explore the impacts of acupuncture and rehabilitation on post-stroke abnormal patterns of limb movement and evaluate them via rehabilitation method. Ninety cases of post-stroke movement disorder were randomly divided into an acupuncture-rehabilitation group, a body acupuncture group and a medication group, 30 cases in each group. In medication group, the conventional medication in neurological department was administered. In acupuncture-rehabilitation group and body acupuncture group, on the basis of the therapy as medication group, scalp acupuncture (such as parietal area and anterior parietal area, etc.), rehabilitation training and traditional body acupuncture [such as Jianyu (LI 15) and Fengshi (GB 31),etc.] were supplemented. The continuous electric stimulation was applied in body acupuncture group. The treatment lasted for 8 weeks. The assessment of clinical efficacy, Fugl-Meyer score, Modified Ashworth scale (MAS), range of motion (ROM) and shoulder pain score were taken as observation indices for rehabilitation evaluation before and after treatment in each group. The effective rate was 93.1% (27/29) in acupuncture-rehabilitation group, which was superior to 66.7% (20/30) in body acupuncture group and 57.1% (16/28) in control group (both Prehabilitation group were significantly superior to those in body acupuncture group and medication group (Prehabilitation therapy and traditional body acupuncture remarkably improve in post-stroke movement disorder. But acupuncture and rehabilitation therapy is apparently superior to traditional body acupuncture. This therapy can effectively prevent and treat post-stroke abnormal patterns and it is greatly significant in the improvement of survival quality for the patients.

Likelihood of myocardial infarction during stroke rehabilitation preceded by cardiovascular screening and an exercise tolerance test: the Locomotor Experience Applied Post-Stroke (LEAPS) trial.

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Nadeau, Stephen E; Rose, Dorian Kay; Dobkin, Bruce; Wu, Samuel S; Dai, Yufeng E; Schofield, Richard; Duncan, Pamela W

2014-12-01

Coronary artery disease is highly prevalent in patients with stroke, but because revascularization does not improve major clinical outcomes in patients with stable coronary artery disease relative to intensive medical therapy, routine evaluation for this disease is not warranted in stroke patients. However, it might be warranted in patients destined to undergo vigorous physical therapy. The Locomotor Experience Applied Post-Stroke study, a randomized controlled trial of 408 participants that tested the relative efficacy of two rehabilitation techniques on functional walking level, provided the opportunity to address this question. The study aims to test the efficacy of screening for cardiovascular disease and an exercise tolerance test in assuring safety among patients undergoing vigorous rehabilitation for gait impairment. All participants were screened for serious cardiovascular and pulmonary conditions. At six-weeks poststroke, they also completed a cardiovascular screening inventory and underwent an exercise tolerance test involving bicycle ergometry. Participants received 36, 90-min sessions of a prescribed physical therapy (three per week), initiated at either two-months or six-months poststroke. Twenty-nine participants were excluded on the basis of the cardiac screening questionnaire, and 15 failed the exercise tolerance test for cardiovascular reasons. No participant experienced a cardiac event during a treatment session. Two participants experienced myocardial infarctions, but continued in the trial. In three additional participants, myocardial infarctions caused or contributed to death. The combination of a negative cardiac screen and the absence of exercise tolerance test failure appeared to have a high negative predictive value for cardiac events during treatment, despite the likelihood of a high prevalence of coronary artery disease in our population. © 2014 World Stroke Organization.

Quantitative assessment of salivary gland function by radioisotopic scanning in a randomized trial of pilocarpine for prevention of radiation Induced Xerostomia

International Nuclear Information System (INIS)

Fard-Esfahani, A.; Modarress-Mosalla, M.; Haddad, P.; Eftekhari, M.; Saghari, M.

2001-01-01

Radioisotope scanning is the best method for objective assessment of salivary gland function. Thus, it was used in a randomized trial of concomitant pilocarpine for assessment of radiation-induced xerostomia, in addition to subjective evaluation by an approved questionnaire and objective standard xerostomia grading. Patients randomized in a placebo-controlled trial of pilocarpine concurrent with irradiation for prevention of radiation-induced xerostomia were evaluated by salivary gland scintigraphy immediately before and 6 months after the end of head and neck radiotherapy. Salivary gland function was measured by ejection fraction (E F) of Technetium-99 m pertechnetate. The mean values for pre-and post-radiotherapy scans were calculated and compared. Also post-radiotherapy scan findings in the two groups of pilocarpine and placebo were compared using the Student's t-test. In addition, comparison was made between the scan results and the subjective findings and objective grading s.Twenty patients underwent the pre-radiotherapy salivary scintigraphy, and also 20 post-radiotherapy scans were performed . Mean parotid E F was 60.85% in the pre-radiotherapy and 9.08% in the post-radiotherapy scans (p<0.01). The means for submandibular glands in the pre-and post-radiotherapy scans were 41% and 11.2%, respectively (p<0.01). Also the mean E F was 14.5% in the pilocarpine group and 3.65 in the placebo group for parotid glands (p=0.07) and 18.3% and 4.1% respectively for submandibular glands (p<0.05). The salivary scans confirmed the subjective and objective xerostomia findings. Salivary gland scintigraphy is a valuable method for evaluation of xerostomia after head and neck radiotherapy, quantitatively demonstrating the protective effect of pilocarpine compared to placebo on salivary glands

The utility of e-Learning to support training for a multicentre bladder online adaptive radiotherapy trial (TROG 10.01-BOLART)

International Nuclear Information System (INIS)

Foroudi, Farshad; Pham, Daniel; Bressel, Mathias; Tongs, David; Rolfo, Aldo; Styles, Colin; Gill, Suki; Kron, Tomas

2013-01-01

Background and purpose: An e-Learning programme appeared useful for providing training and information regarding a multi-centre image guided radiotherapy trial. The aim of this study is to demonstrate the utility of this e-Learning programme. Materials and methods: Modules were created on relevant pelvic anatomy, Cone Beam CT soft tissue recognition and trial details. Radiation therapist participants’ knowledge and confidence were evaluated before, at the end of, and after at least 6 weeks of e-Learning (long term). Results: One hundred and eighty-five participants were recruited from 12 centres, with 118 in the first, and 67 in the second cohort. One hundred and forty-six participants had two tests (pre and post e-Learning) and 39 of these had three tests (pre, post, and long term). There was an increase confidence after completion of modules (p < 0.001). The first cohort pre scores increased from 67 ± 11 to 79 ± 8 (p < 0.001) post. The long term same question score was 73 ± 14 (p = 0.025, comparing to pre-test), and different questions’ score was 77 ± 13 (p = 0.014). In the second cohort, pre-test scores were 64 ± 10, post-test same question score 78 ± 9 (p < 0.001) and different questions’ score 81 ± 11 (p < 0.001). Conclusions: e-Learning for a multi-centre clinical trial was feasible and improved confidence and knowledge

Immediate vs. delayed insertion of intrauterine contraception after second trimester abortion: study protocol for a randomized controlled trial

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Soon Judith A

2011-06-01

Full Text Available Abstract Background We describe the rationale and protocol for a randomized controlled trial (RCT to assess whether intrauterine contraception placed immediately after a second trimester abortion will result in fewer pregnancies than current recommended practice of intended placement at 4 weeks post-abortion. Decision analysis suggests the novel strategy could substantially reduce subsequent unintended pregnancies and abortions. This paper highlights considerations of design, implementation and evaluation of a trial expected to provide rigorous evidence for appropriate insertion timing and health economics of intrauterine contraception after second trimester abortion. Methods/Design Consenting women choosing to use intrauterine contraception after abortion for a pregnancy of 12 to 24 weeks will be randomized to insertion timing groups either immediately (experimental intervention or four weeks (recommended care post abortion. Primary outcome measure is pregnancy rate at one year. Secondary outcomes include: cumulative pregnancy rates over five year follow-up period, comprehensive health economic analyses comparing immediate and delayed insertion groups, and device retention rates, complication rates (infection, expulsion and, contraceptive method satisfaction. Web-based Contraception Satisfaction Questionnaires, clinical records and British Columbia linked health databases will be used to assess primary and secondary outcomes. Enrolment at all clinics in the province performing second trimester abortions began in May 2010 and is expected to complete in late 2011. Data on one year outcomes will be available for analysis in 2014. Discussion The RCT design combined with access to clinical records at all provincial abortion clinics, and to information in provincial single-payer linked administrative health databases, birth registry and hospital records, offers a unique opportunity to evaluate such an approach by determining pregnancy rate at one

The probability of reinforcement per trial affects posttrial responding and subsequent extinction but not within-trial responding.

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Harris, Justin A; Kwok, Dorothy W S

2018-01-01

During magazine approach conditioning, rats do not discriminate between a conditional stimulus (CS) that is consistently reinforced with food and a CS that is occasionally (partially) reinforced, as long as the CSs have the same overall reinforcement rate per second. This implies that rats are indifferent to the probability of reinforcement per trial. However, in the same rats, the per-trial reinforcement rate will affect subsequent extinction-responding extinguishes more rapidly for a CS that was consistently reinforced than for a partially reinforced CS. Here, we trained rats with consistently and partially reinforced CSs that were matched for overall reinforcement rate per second. We measured conditioned responding both during and immediately after the CSs. Differences in the per-trial probability of reinforcement did not affect the acquisition of responding during the CS but did affect subsequent extinction of that responding, and also affected the post-CS response rates during conditioning. Indeed, CSs with the same probability of reinforcement per trial evoked the same amount of post-CS responding even when they differed in overall reinforcement rate and thus evoked different amounts of responding during the CS. We conclude that reinforcement rate per second controls rats' acquisition of responding during the CS, but at the same time, rats also learn specifically about the probability of reinforcement per trial. The latter learning affects the rats' expectation of reinforcement as an outcome of the trial, which influences their ability to detect retrospectively that an opportunity for reinforcement was missed, and, in turn, drives extinction. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Occupational therapy discharge planning for older adults: A protocol for a randomised trial and economic evaluation

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Wales Kylie

2012-07-01

Full Text Available Abstract Background Decreased functional ability is common in older adults after hospitalisation. Lower levels of functional ability increase the risk of hospital readmission and nursing care facility admission. Discharge planning across the hospital and community interface is suggested to increase functional ability and decrease hospital length of stay and hospital readmission. However evidence is limited and the benefits of occupational therapists providing this service has not been investigated. This randomised trial will investigate the clinical effectiveness of a discharge planning program in reducing functional difficulties of older adults post-discharge. This trial will also examine the cost of the intervention and cost effectiveness when compared to in-hospital discharge planning. Methods/design 400 participants admitted to participating hospitals will be recruited. Participants will be 70 years of age and over, have no significant cognitive impairment and be independently mobile at discharge. This study protocol was approved by the ethics committee of Ryde Rehabilitation Human Research Ethics Committee, Western Sydney Local Health District (Westmead Campus Human Research Ethics Committee, Alfred Health Human Research ethics committee for the randomised trial and NSW Population and Health Service Human Research Ethics Committee for data linkage. Participants will provide informed written consent. Participants will be randomly allocated to the intervention or control group. The intervention group will receive discharge planning therapies primarily within their home environment while the control group will receive an in-hospital consultation, both provided by trained occupational therapists. Primary outcome measures will be the Nottingham Extended Activities of Daily Living Scale (NEADL and the Late Life Disability Index (LLDI which will measure functional independence, and participation and limitation in daily life activities

Does suprascapular nerve block reduce shoulder pain following stroke: a double-blind randomised controlled trial with masked outcome assessment

Directory of Open Access Journals (Sweden)

Crotty Maria

2010-09-01

Full Text Available Abstract Background Shoulder pain is a common complication of a stroke which can impede participation in rehabilitation programs and has been associated with poorer outcomes. The evidence base for current medical and therapeutic management options of hemiplegic shoulder pain is limited. This study will evaluate the use of suprascapular nerve block injection as part of an interdisciplinary approach to the treatment of shoulder pain following stroke. The technique has previously been proven safe and effective in the treatment of shoulder pain associated with rheumatoid arthritis and degenerative shoulder conditions but its usefulness in a stroke population is unclear. Methods/Design A double blind randomised placebo controlled trial will assess the effect of a suprascapular nerve block compared with placebo in a population of 66 stroke patients. The trial will measure effect of injection on the primary outcome of pain, and secondary outcomes of function and quality of life. Measurements will take place at baseline, and 1, 4 and 12 weeks post intervention. Both groups will continue to receive routine physiotherapy and standard ward care. Discussion The results of this study could reduce pain symptoms in persons with mechanical shoulder pain post stroke and provide improvement in upper limb function. Trial Registration This trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTR - ACTRN12609000621213.

Evaluating Intermittent Androgen-Deprivation Therapy Phase III Clinical Trials: The Devil Is in the Details.

Science.gov (United States)

Hussain, Maha; Tangen, Catherine; Higano, Celestia; Vogelzang, Nicholas; Thompson, Ian

2016-01-20