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Sample records for randomized trial including

  1. Impact of including Korean randomized controlled trials in Cochrane reviews of acupuncture.

    Directory of Open Access Journals (Sweden)

    Kun Hyung Kim

    Full Text Available OBJECTIVE: Acupuncture is commonly practiced in Korea and is regularly evaluated in clinical trials. Although many Cochrane reviews of acupuncture include searches of both English and Chinese databases, there is no information on the value of searching Korean databases. This study aimed to investigate the impact of searching Korean databases and journals for trials eligible for inclusion in existing Cochrane acupuncture reviews. METHODS: We searched 12 Korean databases and seven Korean journals to identify randomised trials meeting the inclusion criteria for acupuncture reviews in the Cochrane Database of Systematic Reviews. We compared risk of bias assessments of the Korean trials with the trials included in the Cochrane acupuncture reviews. Where possible, we added data from the Korean trials to the existing meta-analyses in the relevant Cochrane review and conducted sensitivity analyses to test the robustness of the results. RESULTS: Sixteen Korean trials (742 participants met the inclusion criteria for eight Cochrane acupuncture reviews (125 trials; 13,041 participants. Inclusion of the Korean trials provided data for 20% of existing meta-analyses (24 out of 120. Inclusion of the Korean trials did not change the direction of effect in any of the existing meta-analyses. The effect size and heterogeneity remained mostly unchanged. In only one meta-analysis did the significance change. Compared to the studies included in the Cochrane acupuncture reviews, the risk of bias in the Korean trials was higher in terms of outcome assessor blinding and allocation concealment. CONCLUSIONS: Many Korean studies contributed additional data to the existing meta-analyses in Cochrane acupuncture reviews. Although inclusion of these studies did not alter the results of the meta-analyses, comprehensive searches of the literature are important to avoid potential language bias. The identification and inclusion of eligible Korean trials should be considered for

  2. Robustness assessments are needed to reduce bias in meta-analyses that include zero-event randomized trials

    DEFF Research Database (Denmark)

    Keus, F; Wetterslev, J; Gluud, C

    2009-01-01

    OBJECTIVES: Meta-analysis of randomized trials with binary data can use a variety of statistical methods. Zero-event trials may create analytic problems. We explored how different methods may impact inferences from meta-analyses containing zero-event trials. METHODS: Five levels of statistical...... of statistical method on inference. RESULTS: In seven meta-analyses of seven outcomes from 15 trials, there were zero-event trials in 0 to 71.4% of the trials. We found inconsistency in significance in one of seven outcomes (14%; 95% confidence limit 0.4%-57.9%). There was also considerable variability...... in the confidence limits, the intervention-effect estimates, and heterogeneity for all outcomes. CONCLUSIONS: The statistical method may influence the inference drawn from a meta-analysis that includes zero-event trials. Robustness assessments are needed to reduce bias in meta-analyses that include zero...

  3. Adjuvant occupational therapy for work-related major depression works: randomized trial including economic evaluation.

    Science.gov (United States)

    Schene, Aart H; Koeter, Maarten W J; Kikkert, Martijn J; Swinkels, Jan A; McCrone, Paul

    2007-03-01

    Major depression has far-reaching consequences for work functioning and absenteeism. In most cases depression is treated by medication and clinical management. The addition of occupational therapy (OT) might improve outcome. We determined the cost-effectiveness of the addition of OT to treatment as usual (TAU). Sixty-two adults with major depression and a mean absenteeism of 242 days were randomized to TAU (out-patient psychiatric treatment) or TAU+OT [6 months, including (i) diagnostic phase with occupational history and work reintegration plan, and (ii) therapeutic phase with individual sessions and group sessions]. Main outcome domains were depression, work resumption, work stress and costs. Assessments were at baseline and at 3, 6, 12 and 42 months. The addition of OT to TAU: (i) did not improve depression outcome, (ii) resulted in a reduction in work-loss days during the first 18 months, (iii) did not increase work stress, and (iv) had a 75.5% probability of being more cost-effective than TAU alone. Addition of OT to good clinical practice does not improve depression outcome, improves productivity without increasing work stress and is superior to TAU in terms of cost-effectiveness.

  4. Results of the 2-Year Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS) Randomized Trial.

    Science.gov (United States)

    Dugel, Pravin U; Tolentino, Michael; Feiner, Leonard; Kozma, Petra; Leroy, Annick

    2016-10-01

    The Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS) trial was designed to evaluate the long-term efficacy and safety profile of ocriplasmin for the treatment of symptomatic vitreomacular adhesion (VMA)/vitreomacular traction, including full-thickness macular hole (FTMH). Phase 3b, randomized, sham-controlled, double-masked, multicenter clinical trial. Sample size was 220 subjects (146 ocriplasmin, 74 sham) randomized in a 2:1 ratio to receive intravitreal ocriplasmin 0.125 mg or sham injection. The trial involved 12 visits over 24-months. Inclusion criteria included presence of VMA and best-corrected visual acuity (BCVA) of 20/32 or worse in the study eye. Exclusion criteria included FTMH >400 μm, presence of epiretinal membrane (ERM), and aphakia in the study eye. The primary efficacy end point was the proportion of subjects with pharmacologic VMA resolution at day 28. Secondary efficacy end points were assessed at month 24 and included proportion of subjects with BCVA gain from baseline, nonsurgical FTMH closure, vitrectomy, and Visual Function Questionnaire 25 (VFQ-25) outcomes. The OASIS trial met its primary end point with pharmacologic VMA resolution at day 28 being significantly higher in the ocriplasmin group (41.7%) compared with the sham group (6.2%). The treatment effect was maintained until study end. In the ocriplasmin group, pharmacologic VMA resolution at day 28 was higher in subgroups with the following baseline characteristics compared with the complementary subgroups without them: presence of focal VMA, presence of FTMH, absence of ERM, and phakic lens status. In the ocriplasmin group, 50.5% of subjects had a ≥2-line improvement in BCVA from baseline compared with 39.1% of subjects in the sham group. The nonsurgical FTMH closure rate was 30.0% for the ocriplasmin group compared with 15.4% for the sham group. All other secondary end points also favored ocriplasmin over sham. Regarding safety, most

  5. Effect on attendance by including focused information on spirometry in preventive health checks: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ørts, Lene Maria; Løkke, Anders; Bjerregaard, Anne-Louise; Maindal, Helle Terkildsen; Sandbæk, Annelli

    2016-12-01

    Early detection of lung diseases can help to reduce their severity. Lung diseases are among the most frequently occurring and serious diseases worldwide; nonetheless, many patients remain undiagnosed. Preventive health checks including spirometry can detect lung diseases at early stages; however, recruitment for health checks remains a challenge, and little is known about what motivates the attendance. The aim of the study is to examine whether focused information on spirometry in the invitation compared to general information will impact the attendance rate in preventive health checks. This randomized, controlled trial tests the effect of information on spirometry embedded in the Check your Health Preventive Program (CHPP). The CHPP is an open-label, household cluster-randomized, controlled trial offering a preventive health check to 30- to -49-year-olds in a Danish municipality from 2012 to 2017 (n = 26,216). During 2015-2016, 4356 citizens aged 30-49 years will be randomized into two groups. The intervention group receives an invitation which highlights the value and contents of spirometry as part of a health check and information about lung diseases. The comparison group receives a standard invitation containing practical information and specifies the contents of the general health check. Outcomes are (1) differences in attendance rates measured by the proportion of citizens attending each of the two study groups and (2) proportion of persons at risk defined by smoking status and self-reported lung symptoms in the study groups. The proportion of participants with abnormal spirometry assessed at the preventive health check will be compared between the two study groups. The results from the present study will inform future recruitment strategies to health checks. The developed material on content, value, and information about lung disease is feasible and transferable to other populations, making it easy to implement if effective. ClinicalTrials.gov: NCT

  6. Efficacy of Manual Therapy Including Neurodynamic Techniques for the Treatment of Carpal Tunnel Syndrome: A Randomized Controlled Trial.

    Science.gov (United States)

    Wolny, Tomasz; Saulicz, Edward; Linek, Paweł; Shacklock, Michael; Myśliwiec, Andrzej

    2017-05-01

    The purpose of this randomized trial was to compare the efficacy of manual therapy, including the use of neurodynamic techniques, with electrophysical modalities on patients with mild and moderate carpal tunnel syndrome (CTS). The study included 140 CTS patients who were randomly assigned to the manual therapy (MT) group, which included the use of neurodynamic techniques, functional massage, and carpal bone mobilizations techniques, or to the electrophysical modalities (EM) group, which included laser and ultrasound therapy. Nerve conduction, pain severity, symptom severity, and functional status measured by the Boston Carpal Tunnel Questionnaire were assessed before and after treatment. Therapy was conducted twice weekly and both groups received 20 therapy sessions. A baseline assessment revealed group differences in sensory conduction of the median nerve (P therapy, analysis of variance revealed group differences in pain severity (P therapies had a positive effect on nerve conduction, pain reduction, functional status, and subjective symptoms in individuals with CTS. However, the results regarding pain reduction, subjective symptoms, and functional status were better in the MT group. Copyright © 2017. Published by Elsevier Inc.

  7. Quality assessment of delineation and dose planning of early breast cancer patients included in the randomized Skagen Trial 1

    DEFF Research Database (Denmark)

    Francolini, Giulio; Thomsen, Mette S; Yates, Esben S

    2017-01-01

    BACKGROUND AND PURPOSE: To report on a Quality assessment (QA) of Skagen Trial 1, exploring hypofractionation for breast cancer patients with indication for regional nodal radiotherapy. MATERIAL AND METHODS: Deviations from protocol regarding target volume delineations and dose parameters (Dmin......, Dmax, D98%, D95% and D2%) from randomly selected dose plans were assessed. Target volume delineation according to ESTRO guidelines was obtained through atlas based automated segmentation and centrally approved as gold standard (GS). Dice similarity scores (DSC) with original delineations were measured....... Dose parameters measured in the two delineations were reported to assess their dosimetric outcome. RESULTS: Assessment included 88 plans from 12 centres in 4 countries. DSC showed high agreement in contouring, 99% and 96% of the patients had a complete delineation of target volumes and organs at risk...

  8. Transition rates from schizotypal disorder to psychotic disorder for first-contact patients included in the OPUS trial. A randomized clinical trial of integrated treatment and standard treatment

    DEFF Research Database (Denmark)

    Nordentoft, Merete; Thorup, Anne; Petersen, Lone

    2006-01-01

    Only a few randomized clinical trials have tested the effect on transition rates of intervention programs for patients with sub-threshold psychosis-like symptoms.......Only a few randomized clinical trials have tested the effect on transition rates of intervention programs for patients with sub-threshold psychosis-like symptoms....

  9. Reduced dietary sodium intake increases heart rate. A meta-analysis of 63 randomized controlled trials including 72 study populations.

    Directory of Open Access Journals (Sweden)

    Niels eGraudal

    2016-03-01

    Full Text Available Reduced dietary sodium intake (sodium reduction increases heart rate in some studies of animals and humans. As heart rate is independently associated with the development of heart failure and increased risk of premature death a potential increase in heart rate could be a harmful side-effect of sodium reduction. The purpose of the present meta-analysis was to investigate the effect of sodium reduction on heart rate. Relevant studies were retrieved from an updated pool of 176 randomized controlled trials (RCTs published in the period 1973–2014. 63 of the RCTs including 72 study populations reported data on heart rate. In a meta-analysis of these data sodium reduction increased heart rate with 1.65 beats per minute [95% CI: 1.19, 2.11], p < 0.00001, corresponding to 2.4% of the baseline heart rate. This effect was independent of baseline blood pressure. In conclusion sodium reduction increases heart rate by as much (2.4% as it decreases blood pressure (2.5%. This side-effect, which may cause harmful health effects, contributes to the need for a revision of the present dietary guidelines.

  10. The TRENDY multi-center randomized trial on hepatocellular carcinoma - Trial QA including automated treatment planning and benchmark-case results

    NARCIS (Netherlands)

    Habraken, S.J.M.; Sharfo, A.W.M.; Buijsen, J.; Verbakel, W.; Haasbeek, C.J.A.; Ollers, M.C.; Westerveld, H.; Wieringen, N. van; Reerink, O.; Seravalli, E.; Braam, P.M.; Wendling, M.; Lacornerie, T.; Mirabel, X.; Weytjens, R.; Depuydt, L.; Tanadini-Lang, S.; Riesterer, O.; Haustermans, K.; Depuydt, T.; Dwarkasing, R.S.; Willemssen, F.; Heijmen, B.J.M.; Romero, A.

    2017-01-01

    BACKGROUND AND PURPOSE: The TRENDY trial is an international multi-center phase-II study, randomizing hepatocellular carcinoma (HCC) patients between transarterial chemoembolization (TACE) and stereotactic body radiation therapy (SBRT) with a target dose of 48-54Gy in six fractions. The radiotherapy

  11. The TRENDY multi-center randomized trial on hepatocellular carcinoma - Trial QA including automated treatment planning and benchmark-case results

    NARCIS (Netherlands)

    Habraken, Steven J. M.; Sharfo, Abdul Wahab M.; Buijsen, Jeroen; Verbakel, Wilko F. A. R.; Haasbeek, Cornelis J. A.; Öllers, Michel C.; Westerveld, Henrike; van Wieringen, Niek; Reerink, Onne; Seravalli, Enrica; Braam, Pètra M.; Wendling, Markus; Lacornerie, Thomas; Mirabel, Xavier; Weytjens, Reinhilde; Depuydt, Lieselotte; Tanadini-Lang, Stephanie; Riesterer, Oliver; Haustermans, Karin; Depuydt, Tom; Dwarkasing, Roy S.; Willemssen, François E. J. A.; Heijmen, Ben J. M.; Méndez Romero, Alejandra

    2017-01-01

    Background and purpose: The TRENDY trial is an international multi-center phase-II study, randomizing hepatocellular carcinoma (HCC) patients between transarterial chemoembolization (TACE) and stereotactic body radiation therapy (SBRT) with a target dose of 48-54 Gy in six fractions. The

  12. Inconsistency in the items included in tools used in general health research and physical therapy to evaluate the methodological quality of randomized controlled trials: a descriptive analysis

    OpenAIRE

    Armijo-Olivo, Susan; Fuentes, Jorge; Ospina, Maria; Saltaji, Humam; Hartling, Lisa

    2013-01-01

    Background Assessing the risk of bias of randomized controlled trials (RCTs) is crucial to understand how biases affect treatment effect estimates. A number of tools have been developed to evaluate risk of bias of RCTs; however, it is unknown how these tools compare to each other in the items included. The main objective of this study was to describe which individual items are included in RCT quality tools used in general health and physical therapy (PT) research, and how these items compare ...

  13. Effect of including fitness testing in preventive health checks on cardiorespiratory fitness and motivation: study protocol of a randomized controlled trial.

    Science.gov (United States)

    Høj, Kirsten; Skriver, Mette Vinther; Hansen, Anne-Louise Smidt; Christensen, Bo; Maindal, Helle Terkildsen; Sandbæk, Annelli

    2014-10-10

    Preventive health checks may identify individuals with an unhealthy lifestyle and motivate them to change behaviour. However, knowledge about the impact of the different components included in preventive health checks is deficient. The aim of this trial is to evaluate whether including cardiorespiratory fitness testing in preventive health checks 1) increases cardiorespiratory fitness level and motivation to change physical activity behaviour and 2) reduces physical inactivity prevalence and improves self-rated health compared with preventive health checks without fitness testing. An open-label, household-cluster, randomized controlled trial with a two-group parallel design is used. The trial is embedded in a population-based health promotion program, "Check your Health Preventive Program", in which all 30-49 year-old citizens in a Danish municipality are offered a preventive health check. In each arm of the trial, 750 citizens will be recruited (1,500 in total). The primary outcome is cardiorespiratory fitness level assessed by submaximal cycle ergometer testing after one year. An intermediate outcome is the percentage of participants increasing motivation for physical activity behaviour change between baseline and two-weeks follow-up assessed using the Transtheoretical Model's stages of change. Secondary outcomes include changes from baseline to one-year follow-up in physical inactivity prevalence measured by a modified version of the questions developed by Saltin and Grimby, and in self-rated health measures using the Short-Form 12, Health Survey, version 2. This trial will contribute to a critical appraisal of the value of fitness testing as part of preventive health checks. The conduction in real-life community and general practice structures makes the trial findings applicable and transferable to other municipalities providing support to decision-makers in the development of approaches to increase levels of physical activity and improve health. ClinicalTrials

  14. Including the Copenhagen Adduction Exercise in the FIFA 11+ Provides Missing Eccentric Hip Adduction Strength Effect in Male Soccer Players: A Randomized Controlled Trial.

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    Harøy, Joar; Thorborg, Kristian; Serner, Andreas; Bjørkheim, André; Rolstad, Linn E; Hölmich, Per; Bahr, Roald; Andersen, Thor Einar

    2017-11-01

    The FIFA 11+ was developed as a complete warm-up program to prevent injuries in soccer players. Although reduced hip adduction strength is associated with groin injuries, none of the exercises included in the FIFA 11+ seem to specifically target hip adduction strength. To investigate the effect on eccentric hip adduction strength of the FIFA 11+ warm-up program with or without the Copenhagen adduction exercise. Randomized controlled trial; Level of evidence, 1. We recruited 45 eligible players from 2 U19 elite male soccer teams. Players were randomized into 2 groups; 1 group carried out the standard FIFA 11+ program, while the other carried out the FIFA 11+ but replaced the Nordic hamstring exercise with the Copenhagen adduction exercise. Both groups performed the intervention 3 times weekly for 8 weeks. Players completed eccentric strength and sprint testing before and after the intervention. Per-protocol analyses were performed, and 12 players were excluded due to low compliance (FIFA 11+ program (-0.02 N·m/kg [-0.7%]; P = .69). Including the Copenhagen adduction exercise in the FIFA 11+ program increases eccentric hip adduction strength, while the standard FIFA 11+ program does not. Registration: Registration: ISRCTN13731446 (International Standard Randomised Controlled Trial Number registry).

  15. Ginger for Prevention of Antituberculosis-induced Gastrointestinal Adverse Reactions Including Hepatotoxicity: A Randomized Pilot Clinical Trial.

    Science.gov (United States)

    Emrani, Zahra; Shojaei, Esphandiar; Khalili, Hossein

    2016-06-01

    In this study, the potential benefits of ginger in preventing antituberculosis drug-induced gastrointestinal adverse reactions including hepatotoxicity have been evaluated in patients with tuberculosis. Patients in the ginger and placebo groups (30 patients in each group) received either 500 mg ginger (Zintoma)(®) or placebo one-half hour before each daily dose of antituberculosis drugs for 4 weeks. Patients' gastrointestinal complaints (nausea, vomiting, dyspepsia, and abdominal pain) and antituberculosis drug-induced hepatotoxicity were recorded during the study period. In this cohort, nausea was the most common antituberculosis drug-induced gastrointestinal adverse reactions. Forty eight (80%) patients experienced nausea. Nausea was more common in the placebo than the ginger group [27 (90%) vs 21 (70%), respectively, p = 0.05]. During the study period, 16 (26.7%) patients experienced antituberculosis drug-induced hepatotoxicity. Patients in the ginger group experienced less, but not statistically significant, antituberculosis drug-induced hepatotoxicity than the placebo group (16.7% vs 36.7%, respectively, p = 0.07). In conclusion, ginger may be a potential option for prevention of antituberculosis drug-induced gastrointestinal adverse reactions including hepatotoxicity. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  16. Dataset for Phase I randomized clinical trial for safety and tolerability of GET 73 in single and repeated ascending doses including preliminary pharmacokinetic parameters

    Directory of Open Access Journals (Sweden)

    Carolina L. Haass-Koffler

    2017-12-01

    Full Text Available The data in this article outline the methods used for the administration of GET 73 in the first time-in-human manuscript entitled “Phase I randomized clinical trial for the safety, tolerability and preliminary pharmacokinetics of the mGluR5 negative allosteric modulator GET 73 following single and repeated doses in healthy male volunteers” (Haass-Koffler et al., 2017 [1]. Data sets are provided in two different manners. The first series of tables provided includes procedural information about the experiments conducted. The next series of tables provided includes Pharmacokinetic (PK parameters for GET 73 and its main metabolite MET 2. This set of data is comprised by two experiments: Experiment 1 references a single ascending dose administration of GET 73 and Experiment 2 references a repeated ascending dose administration of GET 73. Keywords: Glutamate receptor subtype 5 (mGlu5, Allosteric modulator, GET 73, Safety, Tolerability

  17. Pelvic floor muscle training included in a pregnancy exercise program is effective in primary prevention of urinary incontinence: a randomized controlled trial.

    Science.gov (United States)

    Pelaez, Mireia; Gonzalez-Cerron, Silvia; Montejo, Rocío; Barakat, Rubén

    2014-01-01

    To investigate the effect of pelvic floor muscle training (PFMT) taught in a general exercise class during pregnancy on the prevention of urinary incontinence (UI) in nulliparous continent pregnant women. This was a unicenter two armed randomized controlled trial. One hundred sixty-nine women were randomized by a central computer system to an exercise group (EG) (exercise class including PFMT) (n = 73) or a control group (CG) (n = 96). 10.1% loss to follow-up: 10 from EG and 7 from CG. The intervention consisted of 70-75 sessions (22 weeks, three times per week, 55-60 min/session including 10 min of PFMT). The CG received usual care (which included follow up by midwifes including information about PFMT). Questions on prevalence and degree of UI were posed before (week 10-14) and after intervention (week 36-39) using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). At the end of the intervention, there was a statistically significant difference in favor of the EG. Reported frequency of UI [Never: CG: 54/60.7%, EG: 60/95.2% (P prevention of UI in primiparous pregnant women. © 2013 Wiley Periodicals, Inc.

  18. Medium term effects of including manual therapy in a pulmonary rehabilitation program for chronic obstructive pulmonary disease (COPD): a randomized controlled pilot trial.

    Science.gov (United States)

    Engel, Roger Mark; Gonski, Peter; Beath, Ken; Vemulpad, Subramanyam

    2016-05-01

    Randomized clinical trial. To investigate the effect of including manual therapy (MT) in a pulmonary rehabilitation program for patients with chronic obstructive pulmonary disease (COPD). The primary source of exercise limitation in people with COPD is dyspnea. The dyspnea is partly caused by changes in chest wall mechanics, with an increase in chest wall rigidity (CWR) contributing to a decrease in lung function. As MT is known to increase joint mobility, administering MT to people with COPD carries with it the potential to influence CWR and lung function. Thirty-three participants with COPD, aged between 55 and 70 years (mean = 65·5±4 years), were randomly assigned to three groups: pulmonary rehabilitation (PR) only, soft tissue therapy (ST) and PR, and ST, spinal manipulative therapy (SM), and PR. Outcome measures including forced expiratory volume in the 1st second (FEV1), forced vital capacity (FVC), 6-minute walking test (6MWT), St. George's respiratory questionnaire (SGRQ), and the hospital anxiety and depression (HAD) scale were recorded at 0, 8, 16, and 24 weeks. There was a significant difference in FVC between the three groups at 24 weeks (P = 0·04). For the ST+SM+PR group versus PR only the increase was 0·40 l (CI: 0·02, 0·79; P = 0·03). No major or moderate adverse events (AE) were reported following the administration of 131 ST and 272 SM interventions. The increase in FVC is a unique finding. Although the underlying mechanisms responsible for this outcome are not yet understood, the most likely explanation is the synergistic effect resulting from the combination of interventions. These results support the call for a larger clinical trial in the use of MT for COPD.

  19. Prevention of diabetes in overweight/obese children through a family based intervention program including supervised exercise (PREDIKID project): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Arenaza, Lide; Medrano, María; Amasene, María; Rodríguez-Vigil, Beatriz; Díez, Ignacio; Graña, Manuel; Tobalina, Ignacio; Maiz, Edurne; Arteche, Edurne; Larrarte, Eider; Huybrechts, Inge; Davis, Catherine L; Ruiz, Jonatan R; Ortega, Francisco B; Margareto, Javier; Labayen, Idoia

    2017-08-10

    The global pandemic of obesity has led to an increased risk for prediabetes and type-2 diabetes (T2D). The aims of the current project are: (1) to evaluate the effect of a 22-week family based intervention program, including supervised exercise, on insulin resistance syndrome (IRS) risk in children with a high risk of developing T2D and (2) to identify the profile of microRNA in circulating exosomes and in peripheral blood mononuclear cells in children with a high risk of developing T2D and its response to a multidisciplinary intervention program including exercise. A total of 84 children, aged 8-12 years, with a high risk of T2D will be included and randomly assigned to control (N = 42) or intervention (N = 42) groups. The control group will receive a family based lifestyle education and psycho-educational program (2 days/month), while the intervention group will attend the same lifestyle education and psycho-educational program plus the exercise program (3 days/week, 90 min per session including warm-up, moderate to vigorous aerobic activities, and strength exercises). The following measurements will be evaluated at baseline prior to randomization and after the intervention: fasting insulin, glucose and hemoglobin A1c; body composition (dual-energy X-ray absorptiometry); ectopic fat (magnetic resonance imaging); microRNA expression in circulating exosomes and in peripheral blood mononuclear cells (MiSeq; Illumina); cardiorespiratory fitness (cardiopulmonary exercise testing); dietary habits and physical activity (accelerometry). Prevention and identification of children with a high risk of developing T2D could help to improve their cardiovascular health and to reduce the comorbidities associated with obesity. ClinicalTrials.gov, ID: NCT03027726 . Registered on 16 January 2017.

  20. Comparison of treatment effect estimates for pharmacological randomized controlled trials enrolling older adults only and those including adults: a meta-epidemiological study.

    Directory of Open Access Journals (Sweden)

    Valérie Seegers

    Full Text Available CONTEXT: Older adults are underrepresented in clinical research. To assess therapeutic efficacy in older patients, some randomized controlled trials (RCTs include older adults only. OBJECTIVE: To compare treatment effects between RCTs including older adults only (elderly RCTs and RCTs including all adults (adult RCTs by a meta-epidemiological approach. METHODS: All systematic reviews published in the Cochrane Library (Issue 4, 2011 were screened. Eligible studies were meta-analyses of binary outcomes of pharmacologic treatment including at least one elderly RCT and at least one adult RCT. For each meta-analysis, we compared summary odds ratios for elderly RCTs and adult RCTs by calculating a ratio of odds ratios (ROR. A summary ROR was estimated across all meta-analyses. RESULTS: We selected 55 meta-analyses including 524 RCTs (17% elderly RCTs. The treatment effects differed beyond that expected by chance for 7 (13% meta-analyses, showing more favourable treatment effects in elderly RCTs in 5 cases and in adult RCTs in 2 cases. The summary ROR was 0.91 (95% CI, 0.77-1.08, p = 0.28, with substantial heterogeneity (I(2 = 51% and τ(2 = 0.14. Sensitivity and subgroup analyses by type-of-age RCT (elderly RCTs vs RCTs excluding older adults and vs RCTs of mixed-age adults, type of outcome (mortality or other and type of comparator (placebo or active drug yielded similar results. CONCLUSIONS: The efficacy of pharmacologic treatments did not significantly differ, on average, between RCTs including older adults only and RCTs of all adults. However, clinically important discrepancies may occur and should be considered when generalizing evidence from all adults to older adults.

  1. A water-based training program that include perturbation exercises to improve stepping responses in older adults: study protocol for a randomized controlled cross-over trial

    Directory of Open Access Journals (Sweden)

    Tsedek Irit

    2008-08-01

    Full Text Available Abstract Background Gait and balance impairments may increase the risk of falls, the leading cause of accidental death in the elderly population. Fall-related injuries constitute a serious public health problem associated with high costs for society as well as human suffering. A rapid step is the most important protective postural strategy, acting to recover equilibrium and prevent a fall from initiating. It can arise from large perturbations, but also frequently as a consequence of volitional movements. We propose to use a novel water-based training program which includes specific perturbation exercises that will target the stepping responses that could potentially have a profound effect in reducing risk of falling. We describe the water-based balance training program and a study protocol to evaluate its efficacy (Trial registration number #NCT00708136. Methods/Design The proposed water-based training program involves use of unpredictable, multi-directional perturbations in a group setting to evoke compensatory and volitional stepping responses. Perturbations are made by pushing slightly the subjects and by water turbulence, in 24 training sessions conducted over 12 weeks. Concurrent cognitive tasks during movement tasks are included. Principles of physical training and exercise including awareness, continuity, motivation, overload, periodicity, progression and specificity were used in the development of this novel program. Specific goals are to increase the speed of stepping responses and improve the postural control mechanism and physical functioning. A prospective, randomized, cross-over trial with concealed allocation, assessor blinding and intention-to-treat analysis will be performed to evaluate the efficacy of the water-based training program. A total of 36 community-dwelling adults (age 65–88 with no recent history of instability or falling will be assigned to either the perturbation-based training or a control group (no training

  2. [Controlled randomized clinical trials].

    Science.gov (United States)

    Jaillon, Patrice

    2007-01-01

    It is generally agreed that the first comparative clinical trial in history was done by James Lind in 1747, in the treatment of scurvy. The general bases of modern experimental medicine were published by Claude Bernard in 1865. However, it is the development of new drugs and the evolution of methodological concepts that led to the first randomized controlled clinical trial, in 1948, which showed that the effects of streptomycin on pulmonary tuberculosis were significantly different from those of a placebo. Today, "evidence-based" medicine aims to rationalize the medical decision-making process by taking into account, first and foremost, the results of controlled randomized clinical trials, which provide the highest level of evidence. In the second half of the 20th century it became clear that different kinds of clinical trials might not provide the same level of evidence. Practitioners' intimate convictions must be challenged by the results of controlled clinical trials. Take the CAST trial for example, which, in 1989, tested antiarrhythmic drugs versus placebo in patients with myocardial infarction. It was well known that ventricular arrhythmias were a factor of poor prognosis in coronary heart disease, and it was therefore considered self-evident that drug suppression of these ventricular arrhythmias would reduce the mortality rate. In the event, the CAST trial showed the exact opposite, with an almost 3-fold increase in total mortality among patients with coronary heart disease who were treated with antiarrhythmic drugs. These results had a profound impact on the use of antiarrythmic drugs, which became contraindicated after myocardial infarction. A clinical trial has to fulfill certain methodological standards to be accepted as evidence-based medicine. First, a working hypothesis has to be formulated, and then the primary outcome measure must be chosen before beginning the study. An appropriate major endpoint for efficacy must be selected, in keeping with the

  3. New application of dydrogesterone as a part of a progestin-primed ovarian stimulation protocol for IVF: a randomized controlled trial including 516 first IVF/ICSI cycles.

    Science.gov (United States)

    Yu, Sha; Long, Hui; Chang, Hannah Ya-Ning; Liu, Yali; Gao, Hongyuan; Zhu, Jing; Quan, Xinxin; Lyu, Qifeng; Kuang, Yanping; Ai, Ai

    2017-12-29

    Can dydrogesterone (DYG) be used as an alternative progestin in a progesterone primed ovarian stimulation (PPOS) protocol? DYG can be used as an appropriate alternative progestin in a PPOS protocol. PPOS is a new ovarian stimulation regimen based on a freeze-all strategy that uses progestin as an alternative to a GnRH analog for suppressing a premature LH surge during the follicular phase. Medroxyprogesterone acetate (MPA) has been successfully used as an adjuvant to gonadotrophin in the PPOS protocol. However, the use of MPA may lead to stronger pituitary suppression and thus may require a higher dosage of hMG and a longer duration of ovarian stimulation than that of conventional ovarian stimulation protocol. A prospective RCT including 516 patients was performed between November 2015 and November 2016. Computerized randomization was conducted to assign participants at a 1:1 ratio into two treatment groups: an hMG + DYG group (260 patients) or an hMG + MPA group (256 patients) followed by IVF or ICSI with the freeze-all strategy. One cycle per patient was included. The primary outcome of the trial was the number of oocytes retrieved. The sample size was chosen to detect a difference of two oocytes with a power of 90%. Patients under 36 years of age with normal ovarian reserve who were undergoing their first IVF/ICSI procedure due to tubal factor infertility were randomized into two groups based on the oral progestin protocol used: hMG co-treatment with DYG (hMG + DYG) or hMG co-treatment with MPA (hMG + MPA). The different progestin was simultaneously administered at the beginning of menstrual cycle 3 (MC3). Oocyte maturation was co-triggered by administration of a GnRH agonist and hCG. All viable embryos from both protocols were cryopreserved for later transfer. Only the first frozen embryo transfer (FET) cycle was included in our study. The embryological and clinical outcomes were measured. Basic characteristics, such as age, BMI and infertility duration, in

  4. Intralesional immunotherapy with tuberculin purified protein derivative (PPD) in recalcitrant wart: A randomized, placebo-controlled, double-blind clinical trial including an extra group of candidates for cryotherapy.

    Science.gov (United States)

    Amirnia, Mehdi; Khodaeiani, Effat; Fouladi, Daniel F; Masoudnia, Sima

    2016-01-01

    Due to paucity of randomized clinical trials, intralesional immunotherapy has not been yet accepted as a standard therapeutic method. To examine the efficacy and safety of intralesional immunotherapy with tuberculin purified protein derivative (PPD) for treating recalcitrant wart. In this randomized, placebo-controlled, double-blind clinical trial, a total of 69 patients with recalcitrant warts received either intralesional PPD antigen (n = 35) or intralesional saline (n = 34) for six times at 2-week intervals. A third group of candidates for cryotherapy (n = 33) was also included. The decrease in lesion size (good: complete response, intermediate: 50-99% improvement, poor: cryotherapy patients, respectively (PPD versus placebo: p cryotherapy: p cryotherapy groups, respectively (p > 0.05). Intralesional immunotherapy with PPD antigen is highly effective and safe for treating recalcitrant warts. IRCT201407089844N3 in the Iranian Registry of Clinical Trials (IRCT).

  5. Short- and Medium-Term Efficacy of a Web-Based Computer-Tailored Nutrition Education Intervention for Adults Including Cognitive and Environmental Feedback: Randomized Controlled Trial

    Science.gov (United States)

    Lechner, Lilian; de Vries, Hein; Candel, Math JJM; Oenema, Anke

    2015-01-01

    Background Web-based, computer-tailored nutrition education interventions can be effective in modifying self-reported dietary behaviors. Traditional computer-tailored programs primarily targeted individual cognitions (knowledge, awareness, attitude, self-efficacy). Tailoring on additional variables such as self-regulation processes and environmental-level factors (the home food environment arrangement and perception of availability and prices of healthy food products in supermarkets) may improve efficacy and effect sizes (ES) of Web-based computer-tailored nutrition education interventions. Objective This study evaluated the short- and medium-term efficacy and educational differences in efficacy of a cognitive and environmental feedback version of a Web-based computer-tailored nutrition education intervention on self-reported fruit, vegetable, high-energy snack, and saturated fat intake compared to generic nutrition information in the total sample and among participants who did not comply with dietary guidelines (the risk groups). Methods A randomized controlled trial was conducted with a basic (tailored intervention targeting individual cognition and self-regulation processes; n=456), plus (basic intervention additionally targeting environmental-level factors; n=459), and control (generic nutrition information; n=434) group. Participants were recruited from the general population and randomly assigned to a study group. Self-reported fruit, vegetable, high-energy snack, and saturated fat intake were assessed at baseline and at 1- (T1) and 4-months (T2) postintervention using online questionnaires. Linear mixed model analyses examined group differences in change over time. Educational differences were examined with group×time×education interaction terms. Results In the total sample, the basic (T1: ES=–0.30; T2: ES=–0.18) and plus intervention groups (T1: ES=–0.29; T2: ES=–0.27) had larger decreases in high-energy snack intake than the control group. The

  6. Registration of randomized clinical trials

    DEFF Research Database (Denmark)

    Østervig, R M; Sonne, A; Rasmussen, L S

    2015-01-01

    starting enrolment before 2010 to 63.2% after 2010 (24/38, P clinical trials were registered at clinicaltrials.gov. CONCLUSION: Many published randomized controlled trials from Acta Anaesthesiologica Scandinavica were not adequately registered but the requirement of trial registration has...... the proportion of correctly registered randomized controlled trials (RCTs) published in Acta from 2009 to 2014. METHODS: We manually searched all Acta issues from 2009 to 2014 for RCTs. Information about timing of data collection and registration in trial registries was extracted. We classified RCTs as correctly...... registered when it could be verified that patient enrolment was started after registration in a trial registry. RESULTS: We identified 200 RCTs. Dates for patient enrolment were not specified in 51 (25.5%). The proportion of correctly registered trials increased significantly from 17.1% (19/111) for trials...

  7. a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    MS Yıldırım

    2016-02-01

    Full Text Available The aim of this study was to compare the effects of static stretching, proprioceptive neuromuscular facilitation (PNF stretching and Mulligan technique on hip flexion range of motion (ROM in subjects with bilateral hamstring tightness. A total of 40 students (mean age: 21.5±1.3 years, mean body height: 172.8±8.2 cm, mean body mass index: 21.9±3.0 kg • m-2 with bilateral hamstring tightness were enrolled in this randomized trial, of whom 26 completed the study. Subjects were divided into 4 groups performing (I typical static stretching, (II PNF stretching, (III Mulligan traction straight leg raise (TSLR technique, (IV no intervention. Hip flexion ROM was measured using a digital goniometer with the passive straight leg raise test before and after 4 weeks by two physiotherapists blinded to the groups. 52 extremities of 26 subjects were analyzed. Hip flexion ROM increased in all three intervention groups (p<0.05 but not in the no-intervention group after 4 weeks. A statistically significant change in initial–final assessment differences of hip flexion ROM was found between groups (p<0.001 in favour of PNF stretching and Mulligan TSLR technique in comparison to typical static stretching (p=0.016 and p=0.02, respectively. No significant difference was found between Mulligan TSLR technique and PNF stretching (p=0.920. The initial–final assessment difference of hip flexion ROM was similar in typical static stretching and no intervention (p=0.491. A 4-week stretching intervention is beneficial for increasing hip flexion ROM in bilateral hamstring tightness. However, PNF stretching and Mulligan TSLR technique are superior to typical static stretching. These two interventions can be alternatively used for stretching in hamstring tightness.

  8. Can supervised group exercises including ergonomic advice reduce the prevalence and severity of low back pain and pelvic girdle pain in pregnancy? A randomized controlled trial.

    Science.gov (United States)

    Eggen, Marit Horst; Stuge, Britt; Mowinckel, Petter; Jensen, Kjersti Smee; Hagen, Kåre Birger

    2012-06-01

    Many women have low back pain (LBP) or pelvic girdle pain (PGP) during pregnancy, but there is limited evidence of effective primary and secondary preventive strategies. The purpose of this study was to investigate whether a group-based exercise program can reduce the prevalence and severity of LBP and PGP in pregnant women. An observer-blinded randomized controlled trial with equal assignments to a training group and a control group was conducted. The study was conducted in primary care maternity units in 2 suburban municipalities in the southeastern part of Norway. The participants were 257 pregnant women who were healthy and between 18 and 40 years of age before gestation week 20. The training group received supervised exercises in groups once a week, and the control group received standard care. The main outcome measures were self-reported LBP and self-reported PGP. Secondary outcome measures were pain intensity in the morning and evening, disability, and 8-Item Short-Form Health Survey (SF-8) Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Follow-up measurements were performed at gestation weeks 24, 28, 32, and 36. Overall, there was no effect of the program on the prevalence of PGP (odds ratio = 1.03, 95% confidence interval [CI] = 0.66 to 1.59) or LBP (odds ratio = 0.77, 95% CI = 0.50 to 1.19). For the secondary outcomes, the estimated mean differences between the groups were -0.4 (95% CI = -0.8 to 0.1) for pain intensity in the morning, -0.4 (95% CI = -1.0 to 0.2) for pain intensity in the evening, -1.0 (95% CI = -2.2 to 0.0) for disability, 1.8 (95% CI = 0.0 to 3.7) for the SF-8 PCS, and -0.6 (95% CI = -2.2 to 1.4) for the SF-8 MCS. Due to low statistical power, the estimates for the primary outcomes are imprecise. Supervised group exercise did not reduce the prevalence of LBP or PGP in pregnancy.

  9. Ceftazidime-avibactam Versus Doripenem for the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis: RECAPTURE, a Phase 3 Randomized Trial Program.

    Science.gov (United States)

    Wagenlehner, Florian M; Sobel, Jack D; Newell, Paul; Armstrong, Jon; Huang, Xiangning; Stone, Gregory G; Yates, Katrina; Gasink, Leanne B

    2016-09-15

    The global emergence of carbapenem-resistant Enterobacteriaceae highlights the urgent need to reduce carbapenem dependence. The phase 3 RECAPTURE program compared the efficacy and safety of ceftazidime-avibactam and doripenem in patients with complicated urinary tract infection (cUTI), including acute pyelonephritis. Hospitalized adults with suspected or microbiologically confirmed cUTI/acute pyelonephritis were randomized 1:1 to ceftazidime-avibactam 2000 mg/500 mg every 8 hours or doripenem 500 mg every 8 hours (doses adjusted for renal function), with possible oral antibiotic switch after ≥5 days (total treatment duration up to 10 days or 14 days for patients with bacteremia). Of 1033 randomized patients, 393 and 417 treated with ceftazidime-avibactam and doripenem, respectively, were eligible for the primary efficacy analyses; 19.6% had ceftazidime-nonsusceptible baseline pathogens. Noninferiority of ceftazidime-avibactam vs doripenem was demonstrated for the US Food and Drug Administration co-primary endpoints of (1) patient-reported symptomatic resolution at day 5: 276 of 393 (70.2%) vs 276 of 417 (66.2%) patients (difference, 4.0% [95% confidence interval {CI}, -2.39% to 10.42%]); and (2) combined symptomatic resolution/microbiological eradication at test of cure (TOC): 280 of 393 (71.2%) vs 269 of 417 (64.5%) patients (difference, 6.7% [95% CI, .30% to 13.12%]). Microbiological eradication at TOC (European Medicines Agency primary endpoint) occurred in 304 of 393 (77.4%) ceftazidime-avibactam vs 296 of 417 (71.0%) doripenem patients (difference, 6.4% [95% CI, .33% to 12.36%]), demonstrating superiority at the 5% significance level. Both treatments showed similar efficacy against ceftazidime-nonsusceptible pathogens. Ceftazidime-avibactam had a safety profile consistent with that of ceftazidime alone. Ceftazidime-avibactam was highly effective for the empiric treatment of cUTI (including acute pyelonephritis), and may offer an alternative to carbapenems in

  10. Including a Lower-Extremity Component during Hand-Arm Bimanual Intensive Training does not Attenuate Improvements of the Upper Extremities: A Retrospective Study of Randomized Trials

    Directory of Open Access Journals (Sweden)

    Geoffroy Saussez

    2017-09-01

    Full Text Available Hand-Arm Bimanual Intensive Therapy (HABIT promotes hand function using intensive practice of bimanual functional and play tasks. This intervention has shown to be efficacious to improve upper-extremity (UE function in children with unilateral spastic cerebral palsy (USCP. In addition to UE function deficits, lower-extremity (LE function and UE–LE coordination are also impaired in children with USCP. Recently, a new intervention has been introduced in which the LE is simultaneously engaged during HABIT (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities; HABIT-ILE. Positive effects of this therapy have been demonstrated for both the UE and LE function in children with USCP. However, it is unknown whether the addition of this constant LE component during a bimanual intensive therapy attenuates UE improvements observed in children with USCP. This retrospective study, based on multiple randomized protocols, aims to compare the UE function improvements in children with USCP after HABIT or HABIT-ILE. This study included 86 children with USCP who received 90 h of either HABIT (n = 42 or HABIT-ILE (n = 44 as participants in previous studies. Children were assessed before, after, and 4–6 months after intervention. Primary outcomes were the ABILHAND-Kids and the Assisting Hand Assessment. Secondary measures included the Jebsen-Taylor Test of Hand Function, the Pediatric Evaluation of Disability Inventory [(PEDI; only the self-care functional ability domain] and the Canadian Occupational Performance Measure (COPM. Data analysis was performed using two-way repeated-measures analysis of variance with repeated measures on test sessions. Both groups showed similar, significant improvements for all tests (test session effect p < 0.001; group × test session interaction p > 0.05 except the PEDI and COPM. Larger improvements on these tests were found for the HABIT-ILE group (test session effect p < 0.001; group

  11. a randomized controlled trial.

    African Journals Online (AJOL)

    milk, only an estimated one -fourth of neonates in India were breastfed within ... standard of care in India and mothers are informed about. 6 months of ... weeks postpartum. A random number sequence was generated using a com- puter program. Block randomization was used with a fixed block size of four. Concealment of ...

  12. Hand and Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE) in Children With Unilateral Spastic Cerebral Palsy: A Randomized Trial.

    Science.gov (United States)

    Bleyenheuft, Yannick; Arnould, Carlyne; Brandao, Marina B; Bleyenheuft, Corrine; Gordon, Andrew M

    2015-08-01

    Intensive bimanual training results in more improvement in hand function in children with unilateral spastic cerebral palsy (USCP) than lower intensity conventional interventions. However, it is not known whether combined upper and lower extremity training in an intensive protocol is more efficacious for upper and lower functional abilities than conventional therapies provided in usual customary care. To determine the efficacy of Hand and Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE) for children with USCP. Twenty-four children with USCP were randomized into 2 groups: an immediate HABIT-ILE group (IHG, initially receiving HABIT-ILE, 10 days = 90 hours), and a delayed HABIT-ILE group (DHG), which continued their conventional/ongoing treatment for an intended total duration of 90 hours. In phase 2, children in the DHG were crossed over to receive HABIT-ILE and children of the IHG were followed in their ongoing conventional therapy. Children were assessed using the Assisting Hand Assessment (AHA, primary outcome), the ABILHAND-Kids, and the Pediatric Evaluation of Disability Inventory. Dexterity (Box and Blocks Test [BBT]) and pinch strength were also measured. Locomotor abilities were assessed with Six-Minute Walk Test (6MWT, primary outcome) and ABILOCO-kids. Social participation was measured with the Assessment of Life-HABITs. A 2 (groups) × 3 (test sessions) analysis of variance indicated significant improvements for primary outcomes (AHA, P therapy. The findings suggest that combined upper and lower extremity in an intensive training protocol may be efficacious for improving both upper and lower extremity function in children with USCP. © The Author(s) 2014.

  13. Randomized clinical trials in HEPATOLOGY

    DEFF Research Database (Denmark)

    Kjaergard, L L; Nikolova, D; Gluud, C

    1999-01-01

    Evidence shows that the quality of randomized clinical trials (RCTs) affects estimates of intervention efficacy, which is significantly exaggerated in low-quality trials. The present study examines the quality of all 235 RCTs published in HEPATOLOGY from the initiation in 1981 through August 1998......-blinding. The median quality score of all trials was 3 points (range, 1-5 points). Multiple logistic regression analysis explored the association between quality and therapeutic areas, number of centers, external funding, year of publication, and country of origin. High-quality trials were most likely to investigate......, single-center trials, and trials with no external funding. Quality did not improve with time and was not associated with country of origin. The main conclusions are that the quality of RCTs in HEPATOLOGY needs improvement and that the probability of high quality increased with the number of centers...

  14. Update to the study protocol, including statistical analysis plan for a randomized clinical trial comparing comprehensive cardiac rehabilitation after heart valve surgery with control

    DEFF Research Database (Denmark)

    Sibilitz, Kirstine Laerum; Kikkenborg Berg, Selina; Hansen, Tina Birgitte

    2015-01-01

    , either valve replacement or repair, remains the treatment of choice. However, post-surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesize that a comprehensive cardiac rehabilitation program can improve physical capacity and self-assessed mental health...... patients 1:1 to an intervention or a control group, using central randomization, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise and a psycho-educational intervention comprising five consultations. The primary outcome is peak oxygen uptake...

  15. Intravaginal stimulation randomized trial.

    Science.gov (United States)

    Smith, J J

    1996-01-01

    The effectiveness of intravaginal electrical stimulation was compared to standard therapy in the treatment of genuine stress urinary incontinence and detrusor instability. A total of 57 women with urinary incontinence was evaluated with video urodynamics and voiding diaries before and after treatment. Of the women 18 with stress urinary incontinence were randomized to electrical stimulation or Kegel exercise and 38 with detrusor instability were randomized to anticholinergic therapy or electrical stimulation. Of patients using electrical stimulation in the stress urinary incontinence group 66% improved and 72% of the patients with detrusor instability treated with electrical stimulation improved. These rates were not statistically significant when compared to traditional therapy. Electrical stimulation is safe and at least as effective as properly performed Kegel and anticholinergic therapy in the treatment of stress urinary incontinence and detrusor instability.

  16. Intensified hand-hygiene campaign including soap-and-water wash may prevent acute infections in office workers, as shown by a recognized-exposure -adjusted analysis of a randomized trial.

    Science.gov (United States)

    Hovi, Tapani; Ollgren, Jukka; Savolainen-Kopra, Carita

    2017-01-09

    Variable exposure to causative agents of acute respiratory (RTI) or gastrointestinal tract infections (GTI) is a significant confounding factor in the analysis of the efficacy of interventions concerning these infections. We had an exceptional opportunity to reanalyze a previously published dataset from a trial assessing the effect of enhanced hand hygiene on the occurrence of RTI or GTI in adults, after adjustment for reported exposure and other covariates. Twenty-one working units (designated clusters) each including at least 50 office employees, totaling 1,270 persons, were randomized into two intervention arms (either using water-and-soap or alcohol-rub in hand cleansing), or in the control arm. Self-reported data was collected through weekly emails and included own symptoms of RTI or GTI, and exposures to other persons with similar symptoms. Differences in the weekly occurrences of RTI and GTI symptoms between the arms were analyzed using multilevel binary regression model with log link with personal and cluster specific random effects, self-reported exposure to homologous disease, randomization triplet, and seasonality as covariates in the Bayesian framework. Over the 16 months duration of the trial, 297 persons in the soap and water arm, 238 persons in the alcohol-based hand rub arm, and 230 controls sent reports. The arms were similar in age distribution and gender ratios. A temporally-associated reported exposure strongly increased the risk of both types of infection in all trial arms. Persons in the soap-and-water arm reported a significantly - about 24% lower weekly prevalence of GTI than the controls whether they had observed an exposure or not during the preceding week, while for RTI, this intervention reduced the prevalence only during weeks without a reported exposure. Alcohol-rub did not affect the symptom prevalence. We conclude that while frequent and careful hand washing with soap and water partially protected office-working adults from GTI, the

  17. Polyurethane on titanium unconstrained disc arthroplasty versus anterior discectomy and fusion for the treatment of cervical disc disease: a review of level I-II randomized clinical trials including clinical outcomes.

    Science.gov (United States)

    Aragonés, María; Hevia, Eduardo; Barrios, Carlos

    2015-12-01

    To contrast the clinical and radiologic outcomes and adverse events of anterior cervical discectomy and fusion (ACDF) with a single cervical disc arthroplasty design, the polyurethane on titanium unconstrained cervical disc (PTUCD). This is a systematic review of randomized clinical trials (RCT) with evidence level I-II reporting clinical outcomes. After a search on different databases including PubMed, Cochrane Central Register of Controlled Trials, and Ovid MEDLINE, a total of 10 RCTs out of 51 studies found were entered in the study. RTCs were searched from the earliest available records in 2005 to November 2014. Out of a total of 1101 patients, 562 were randomly assigned into the PTUCD arthroplasty group and 539 into the ACDF group. The mean follow-up was 30.9 months. Patients undergoing arthroplasty had lower Neck Disability Index, and better SF-36 Physical component scores than ACDF patients. Patients with PTUCD arthroplasty had also less radiological degenerative changes at the upper adjacent level. Overall adverse events were twice more frequent in patients with ACDF. The rate of revision surgery including both adjacent and index level was slightly higher in patients with ACDF, showing no statistically significant difference. According to this review, PTUCD arthroplasty showed a global superiority to ACDF in clinical outcomes. The impact of both surgical techniques on the cervical spine (radiological spine deterioration and/or complications) was more severe in patients undergoing ACDF. However, the rate of revision surgeries at any cervical level was equivalent for ACDF and PTUCD arthroplasty.

  18. A double-blind, randomized trial, including frequent patient–physician contacts and Ramadan-focused advice, assessing vildagliptin and gliclazide in patients with type 2 diabetes fasting during Ramadan: the STEADFAST study

    Directory of Open Access Journals (Sweden)

    Hassanein M

    2014-05-01

    Full Text Available Mohamed Hassanein,1 Khalifa Abdallah,2 Anja Schweizer31Betsi Cadwaladr University Health Board, Wales, United Kingdom; 2Clinical Research Center, Alexandria University Hospital, Alexandria, Egypt; 3Global Medical Affairs, Novartis Pharma AG, Basel, SwitzerlandBackground: Several observational studies were conducted with vildagliptin in patients with type 2 diabetes mellitus (T2DM fasting during Ramadan, showing significantly lower incidences of hypoglycemia with vildagliptin versus sulfonylureas, including gliclazide. It was of interest to complement the existing real-life evidence with data from a randomized, double-blind, clinical trial.Clinical Trials Identifier: NCT01758380.Methods: This multiregional, double-blind study randomized 557 patients with T2DM (mean glycated hemoglobin [HbA1c], 6.9%, previously treated with metformin and any sulfonylurea to receive either vildagliptin (50 mg twice daily or gliclazide plus metformin. The study included four office visits (three pre-Ramadan and multiple telephone contacts, as well as Ramadan-focused advice. Hypoglycemic events were assessed during Ramadan; HbA1c and weight were analyzed before and after Ramadan.Results: The proportion of patients reporting confirmed (<3.9 mmol/L and/or severe hypoglycemic events during Ramadan was 3.0% with vildagliptin and 7.0% with gliclazide (P=0.039; one-sided test, and this was 6.0% and 8.7%, respectively, for any hypoglycemic events (P=0.173. The adjusted mean change pre- to post-Ramadan in HbA1c was 0.05%±0.04% with vildagliptin and -0.03%±0.04% with gliclazide, from baselines of 6.84% and 6.79%, respectively (P=0.165. In both groups, the adjusted mean decrease in weight was -1.1±0.2 kg (P=0.987. Overall safety was similar between the treatments.Conclusion: In line with the results from previous observational studies, vildagliptin was shown in this interventional study to be an effective, safe, and well-tolerated treatment in patients with T2DM fasting

  19. A double-blind, randomized trial, including frequent patient–physician contacts and Ramadan-focused advice, assessing vildagliptin and gliclazide in patients with type 2 diabetes fasting during Ramadan: the STEADFAST study

    Science.gov (United States)

    Hassanein, Mohamed; Abdallah, Khalifa; Schweizer, Anja

    2014-01-01

    Background Several observational studies were conducted with vildagliptin in patients with type 2 diabetes mellitus (T2DM) fasting during Ramadan, showing significantly lower incidences of hypoglycemia with vildagliptin versus sulfonylureas, including gliclazide. It was of interest to complement the existing real-life evidence with data from a randomized, double-blind, clinical trial. Clinical Trials Identifier NCT01758380. Methods This multiregional, double-blind study randomized 557 patients with T2DM (mean glycated hemoglobin [HbA1c], 6.9%), previously treated with metformin and any sulfonylurea to receive either vildagliptin (50 mg twice daily) or gliclazide plus metformin. The study included four office visits (three pre-Ramadan) and multiple telephone contacts, as well as Ramadan-focused advice. Hypoglycemic events were assessed during Ramadan; HbA1c and weight were analyzed before and after Ramadan. Results The proportion of patients reporting confirmed (Ramadan was 3.0% with vildagliptin and 7.0% with gliclazide (P=0.039; one-sided test), and this was 6.0% and 8.7%, respectively, for any hypoglycemic events (P=0.173). The adjusted mean change pre- to post-Ramadan in HbA1c was 0.05%±0.04% with vildagliptin and −0.03%±0.04% with gliclazide, from baselines of 6.84% and 6.79%, respectively (P=0.165). In both groups, the adjusted mean decrease in weight was −1.1±0.2 kg (P=0.987). Overall safety was similar between the treatments. Conclusion In line with the results from previous observational studies, vildagliptin was shown in this interventional study to be an effective, safe, and well-tolerated treatment in patients with T2DM fasting during Ramadan, with a consistently low incidence of hypoglycemia across studies, accompanied by good glycemic and weight control. In contrast, gliclazide showed a lower incidence of hypoglycemia in the present interventional than the previous observational studies. This is suggested to be linked to the specific

  20. J-pouch vs. side-to-end anastomosis after hand-assisted laparoscopic low anterior resection for rectal cancer: A prospective randomized trial on short and long term outcomes including life quality and functional results.

    Science.gov (United States)

    Okkabaz, Nuri; Haksal, Mustafa; Atici, Ali Emre; Altuntas, Yunus Emre; Gundogan, Ersin; Gezen, Fazli Cem; Oncel, Mustafa

    2017-11-01

    To analyze the outcomes of j-pouch and side-to-end anastomosis in rectal cancer patients treated with laparoscopic hand-assisted low anterior resection. Prospective trial on cases randomized to have a colonic j-pouch or a side-to-end anastomosis after low anterior resection. Demographics, characteristics of disease and treatment, perioperative results, and functional outcomes and life quality were compared between the groups. Seventy four patients were randomized. Reservoir creation was withdrawn in 17 (23%) patients, mostly related to reach problem (n = 11, 64.7%). Anastomotic leakage rate was significantly higher in j-pouch group (8 [27.6%] vs. 0, p = 0.004). Stoma closure could not be achieved in 16 (28.1%) patients. Life quality and functional outcomes, measured 4, 8 and 12 months after the stoma reversal, were similar. Colonic j-pouch and side-to-end anastomosis are similar regarding perioperative measures including operation time, rates of postoperative complications, reoperation and 30-day mortality, and hospitalization period except anastomotic leak rate, which is higher in j-pouch group. Postoperative aspects are not different in patients receiving either technique including functional outcomes and life quality for the first year after stoma closure. In our opinion, both techniques may be preferred during the daily practice while performing laparoscopic surgery; but surgeons may be aware of a possibly higher anastomotic leak rate in case of a j-pouch. Copyright © 2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  1. Randomized Clinical Trials in Stroke Research

    OpenAIRE

    Ahn, Chul; Ahn, Daniel

    2010-01-01

    A randomized clinical trial (RCT) is widely regarded as the most rigorous study design to determine the efficacy of intervention since spurious causality and bias associated with other experimental designs can be avoided. The purpose of this article is to provide clinicians and clinical researchers with the types of randomized clinical trials used in stroke studies and to discuss the advantages and limitations in each type of randomized stroke clinical trials.

  2. Randomized Clinical Trials With Biomarkers: Design Issues

    Science.gov (United States)

    McShane, Lisa M.; Korn, Edward L.

    2010-01-01

    Clinical biomarker tests that aid in making treatment decisions will play an important role in achieving personalized medicine for cancer patients. Definitive evaluation of the clinical utility of these biomarkers requires conducting large randomized clinical trials (RCTs). Efficient RCT design is therefore crucial for timely introduction of these medical advances into clinical practice, and a variety of designs have been proposed for this purpose. To guide design and interpretation of RCTs evaluating biomarkers, we present an in-depth comparison of advantages and disadvantages of the commonly used designs. Key aspects of the discussion include efficiency comparisons and special interim monitoring issues that arise because of the complexity of these RCTs. Important ongoing and completed trials are used as examples. We conclude that, in most settings, randomized biomarker-stratified designs (ie, designs that use the biomarker to guide analysis but not treatment assignment) should be used to obtain a rigorous assessment of biomarker clinical utility. PMID:20075367

  3. Minimal sufficient balance randomization for sequential randomized controlled trial designs: results from the ESCAPE trial.

    Science.gov (United States)

    Sajobi, Tolulope T; Singh, Gurbakhshash; Lowerison, Mark W; Engbers, Jordan; Menon, Bijoy K; Demchuk, Andrew M; Goyal, Mayank; Hill, Michael D

    2017-11-02

    We describe the implementation of minimal sufficient balance randomization, a covariate-adaptive randomization technique, used for the "Endovascular treatment for Small Core and Anterior circulation Proximal occlusion with Emphasis on minimizing CT to recanalization times" (ESCAPE) trial. The ESCAPE trial is a prospective, multicenter, randomized clinical trial that enrolled subjects with the following main inclusion criteria: less than 12 h from symptom onset, age 18 years or older, baseline NIHSS score > 5, ASPECTS score > 5 and computed tomography angiography (CTA) evidence of carotid T/L or M1-segment middle cerebral artery (MCA) occlusion, and at least moderate collaterals by CTA. Patients were randomized using a real-time, dynamic, Internet-based, minimal sufficient balance randomization method that balanced the study arms with respect to baseline covariates including age, sex, baseline NIHSS score, site of arterial occlusion, baseline ASPECTS score and treatment with intravenously administered alteplase. Permutation-based tests of group differences confirmed group balance across several baseline covariates including sex (p = 1.00), baseline NIHSS score (p = 0.95), site of arterial occlusion (p = 1.00), baseline ASPECTS score (p = 0.28), treatment with intravenously administered alteplase (p = 0.31), and age (p = 0.67). Results from the ESCAPE trial demonstrate the feasibility and the benefit of this covariate adaptive randomization scheme in small-sample trials and for data monitoring endeavors. ESCAPE trial - NCT01778335 - at www.clinicaltrials.gov . Registered on 29 January 2013.

  4. Cluster randomized trials for pharmacy practice research.

    Science.gov (United States)

    Gums, Tyler; Carter, Barry; Foster, Eric

    2016-06-01

    Introduction Cluster randomized trials (CRTs) are now the gold standard in health services research, including pharmacy-based interventions. Studies of behaviour, epidemiology, lifestyle modifications, educational programs, and health care models are utilizing the strengths of cluster randomized analyses. Methodology The key property of CRTs is the unit of randomization (clusters), which may be different from the unit of analysis (individual). Subject sample size and, ideally, the number of clusters is determined by the relationship of between-cluster and within-cluster variability. The correlation among participants recruited from the same cluster is known as the intraclass correlation coefficient (ICC). Generally, having more clusters with smaller ICC values will lead to smaller sample sizes. When selecting clusters, stratification before randomization may be useful in decreasing imbalances between study arms. Participant recruitment methods can differ from other types of randomized trials, as blinding a behavioural intervention cannot always be done. When to use CRTs can yield results that are relevant for making "real world" decisions. CRTs are often used in non-therapeutic intervention studies (e.g. change in practice guidelines). The advantages of CRT design in pharmacy research have been avoiding contamination and the generalizability of the results. A large CRT that studied physician-pharmacist collaborative management of hypertension is used in this manuscript as a CRT example. The trial, entitled Collaboration Among Pharmacists and physicians To Improve Outcomes Now (CAPTION), was implemented in primary care offices in the United States for hypertensive patients. Limitations CRT design limitations include the need for a large number of clusters, high costs, increased training, increased monitoring, and statistical complexity.

  5. A double-blind, randomized trial, including frequent patient-physician contacts and Ramadan-focused advice, assessing vildagliptin and gliclazide in patients with type 2 diabetes fasting during Ramadan: the STEADFAST study.

    Science.gov (United States)

    Hassanein, Mohamed; Abdallah, Khalifa; Schweizer, Anja

    2014-01-01

    Several observational studies were conducted with vildagliptin in patients with type 2 diabetes mellitus (T2DM) fasting during Ramadan, showing significantly lower incidences of hypoglycemia with vildagliptin versus sulfonylureas, including gliclazide. It was of interest to complement the existing real-life evidence with data from a randomized, double-blind, clinical trial. NCT01758380. This multiregional, double-blind study randomized 557 patients with T2DM (mean glycated hemoglobin [HbA1c], 6.9%), previously treated with metformin and any sulfonylurea to receive either vildagliptin (50 mg twice daily) or gliclazide plus metformin. The study included four office visits (three pre-Ramadan) and multiple telephone contacts, as well as Ramadan-focused advice. Hypoglycemic events were assessed during Ramadan; HbA(1c) and weight were analyzed before and after Ramadan. The proportion of patients reporting confirmed (Ramadan was 3.0% with vildagliptin and 7.0% with gliclazide (P=0.039; one-sided test), and this was 6.0% and 8.7%, respectively, for any hypoglycemic events (P=0.173). The adjusted mean change pre- to post-Ramadan in HbA(1c) was 0.05%±0.04% with vildagliptin and -0.03%±0.04% with gliclazide, from baselines of 6.84% and 6.79%, respectively (P=0.165). In both groups, the adjusted mean decrease in weight was -1.1±0.2 kg (P=0.987). Overall safety was similar between the treatments. In line with the results from previous observational studies, vildagliptin was shown in this interventional study to be an effective, safe, and well-tolerated treatment in patients with T2DM fasting during Ramadan, with a consistently low incidence of hypoglycemia across studies, accompanied by good glycemic and weight control. In contrast, gliclazide showed a lower incidence of hypoglycemia in the present interventional than the previous observational studies. This is suggested to be linked to the specific circumstances of this study, including frequent patient-physician contacts

  6. The design of cluster randomized crossover trials

    NARCIS (Netherlands)

    Rietbergen, C.; Moerbeek, M.

    2011-01-01

    The inefficiency induced by between-cluster variation in cluster randomized (CR) trials can be reduced by implementing a crossover (CO) design. In a simple CO trial, each subject receives each treatment in random order. A powerful characteristic of this design is that each subject serves as its own

  7. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly...

  8. An energy-reduced dietary pattern, including moderate protein and increased nonfat dairy intake combined with walking promotes beneficial body composition and metabolic changes in women with excess adiposity: a randomized comparative trial.

    Science.gov (United States)

    Shlisky, Julie D; Durward, Carrie M; Zack, Melissa K; Gugger, Carolyn K; Campbell, Jessica K; Nickols-Richardson, Sharon M

    2015-09-01

    Moderate protein and nonfat dairy intake within an energy-reduced diet (ERD) may contribute to health benefits achieved with body weight (BW) loss. The current study examined the effectiveness of a weight-loss/weight-loss maintenance intervention using an ERD with moderate dietary protein (30% of kcals) and increased nonfat dairy intake (4-5 svg/d), including yogurt (INT group) and daily walking compared to an ERD with standard protein (16-17% of kcals) and standard nonfat dairy intake (3 svg/d) (COM group) with daily walking. A randomized comparative trial with 104 healthy premenopausal women with overweight/obesity was conducted in a university setting. Women were randomized to INT group or COM group. Anthropometric measurements, as well as dietary intake, selected vital signs, resting energy expenditure, blood lipids, glucose, insulin, and selected adipose-derived hormones were measured at baseline, and weeks 2, 12, and 24. Targets for dietary protein and nonfat dairy intake, while initially achieved, were not sustained in the INT group. There were no significant effects of diet group on anthropometric measurements. Women in the INT group and COM group, respectively, reduced BW (-4.9 ± 3.2 and -4.3 ± 3.3 kg, P < 0.001) and fat mass (-3.0 ± 2.2 and -2.3 ± 2.3 kg, P < 0.001) during the 12-week weight-loss phase and maintained these losses at 24 weeks. Both groups experienced significant decreases in body mass index, fat-free soft tissue mass, body fat percentage, waist and hip circumferences and serum triglycerides, total cholesterol, and leptin (all P < 0.001). Healthy premenopausal women with excess adiposity effectively lost BW and fat mass and improved some metabolic risk factors following an ERD with approximately 20% protein and 3 svg/d of nonfat dairy intake.

  9. Electrocardiogram ST Analysis During Labor : A Systematic Review and Meta-analysis of Randomized Controlled Trials

    NARCIS (Netherlands)

    Saccone, Gabriele; Schuit, Ewoud; Amer-Wåhlin, Isis; Xodo, Serena; Berghella, Vincenzo

    OBJECTIVE: To compare the effectiveness of cardiotocography plus ST analysis with cardiotocography alone during labor. DATA SOURCES: Randomized controlled trials were identified by searching electronic databases. METHODS OF STUDY SELECTION: We included all randomized controlled trials comparing

  10. Blinding in randomized clinical trials: imposed impartiality

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Boutron, I

    2011-01-01

    Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations...

  11. Dynamic randomization and a randomization model for clinical trials data.

    Science.gov (United States)

    Kaiser, Lee D

    2012-12-20

    Randomization models are useful in supporting the validity of linear model analyses applied to data from a clinical trial that employed randomization via permuted blocks. Here, a randomization model for clinical trials data with arbitrary randomization methodology is developed, with treatment effect estimators and standard error estimators valid from a randomization perspective. A central limit theorem for the treatment effect estimator is also derived. As with permuted-blocks randomization, a typical linear model analysis provides results similar to the randomization model results when, roughly, unit effects display no pattern over time. A key requirement for the randomization inference is that the unconditional probability that any patient receives active treatment is constant across patients; when this probability condition is violated, the treatment effect estimator is biased from a randomization perspective. Most randomization methods for balanced, 1 to 1, treatment allocation satisfy this condition. However, many dynamic randomization methods for planned unbalanced treatment allocation, like 2 to 1, do not satisfy this constant probability condition, and these methods should be avoided. Copyright © 2012 John Wiley & Sons, Ltd.

  12. Cluster Randomized Trials with Treatment Noncompliance

    Science.gov (United States)

    Jo, Booil; Asparouhov, Tihomir; Muthen, Bengt O.; Ialongo, Nicholas S.; Brown, C. Hendricks

    2008-01-01

    Cluster randomized trials (CRTs) have been widely used in field experiments treating a cluster of individuals as the unit of randomization. This study focused particularly on situations where CRTs are accompanied by a common complication, namely, treatment noncompliance or, more generally, intervention nonadherence. In CRTs, compliance may be…

  13. Do randomized controlled trials discuss healthcare costs?

    Directory of Open Access Journals (Sweden)

    G Michael Allan

    Full Text Available BACKGROUND: Healthcare costs, particularly pharmaceutical costs, are a dominant issue for most healthcare organizations, but it is unclear if randomized controlled trials (RCTs routinely discuss costs. Our objective was to assess the frequency and factors associated with the inclusion of costs in RCTs. METHODS AND FINDINGS: We randomly sampled 188 RCTs spanning three years (2003-2005 from six high impact journals. The sample size for RCTs was based on a calculation to estimate the inclusion of actual drug costs with a precision of +/-3%. Two reviewers independently extracted cost data and study characteristics. Frequencies were calculated and potential characteristics associated with the inclusion of costs were explored. Actual drug costs were included in 4.7% (9/188 of RCTs; any actual costs were included in 7.4% (14/188 of RCTs; and any mention of costs was included in 27.7% (52/188 of RCTs. As the amount of industry funding increased across RCTs, from non-profit to mixed to fully industry funded RCTs, there was a statistically significant reduction in the number of RCTs with any actual costs (Cochran-Armitage test, p = 0.005 and any mention of costs (Cochran-Armitage test, p = 0.02. Logistic regression analysis also indicated funding was associated with the inclusion of any actual cost (OR = 0.34, p = 0.009 or any mention of costs (OR = 0.63, p = 0.02. Journal, study conclusions, study location, primary author's country and product age were not associated with inclusion of cost information. CONCLUSION: While physicians are encouraged to consider costs when prescribing drugs for their patients, actual drug costs were provided in only 5% of RCTs and were not mentioned at all in 72% of RCTs. Industry funded trials were less likely to include cost information. No other factors were associated with the inclusion of cost information.

  14. Randomized controlled trials of COX-2 inhibitors

    DEFF Research Database (Denmark)

    Stefansdottir, Gudrun; De Bruin, Marie L; Knol, Mirjam J

    2011-01-01

    BACKGROUND: Naproxen, ibuprofen and diclofenac are frequently used as comparators in randomized controlled trials (RCTs) on the safety and efficacy of cyclooxygenase (COX)-2 inhibitors. Different comparator doses may influence the results of RCTs. It has been hypothesized that RCTs of COX-2...... 1995 and 2009 in which celecoxib or rofecoxib were compared with naproxen, ibuprofen or diclofenac. All articles labelled as RCTs mentioning rofecoxib or celecoxib and one or more of the comparator drugs in the title and/or abstract were included. We extracted information on doses of both non...... dose trends in the case of rofecoxib. CONCLUSIONS: Although the dose trends over time differed for RCTs comparing rofecoxib and celecoxib with diclofenac, ibuprofen or naproxen, the results of our study do not support the hypothesis that dose trends influenced the decision to continue marketing...

  15. Fool's gold, lost treasures, and the randomized clinical trial.

    Science.gov (United States)

    Stewart, David J; Kurzrock, Razelle

    2013-04-16

    Randomized controlled trials with a survival endpoint are the gold standard for clinical research, but have failed to achieve cures for most advanced malignancies. The high costs of randomized clinical trials slow progress (thereby causing avoidable loss of life) and increase health care costs. A malignancy may be caused by several different mutations. Therapies effective vs one mutation may be discarded due to lack of statistical significance across the entire population. Conversely, expensive large randomized trials may have sufficient statistical power to demonstrate benefit despite the therapy only working in subgroups. Non-cost-effective therapy is then applied to all patients (including subgroups it cannot help). Randomized trials comparing therapies with different mechanisms of action are misleading since they may conclude the therapies are "equivalent" despite benefitting different subpopulations, or may erroneously conclude that one therapy is superior simply because it targets a larger subpopulation. Furthermore, minor variances in patient selection may determine study outcome, a therapy may be discarded as ineffective despite substantial benefit in one subpopulation if harmful in another, randomized trials may more effectively detect therapies with minor benefit in most patients vs marked benefit in subpopulations, and randomized trials in unselected patients may erroneously conclude that "shot-gun" combinations are superior to single agents when sequential administration of personalized single agents might work better and spare patients treatment with drugs that cannot help them. We must identify predictive biomarkers early by comparing responding to progressing patients in phase I-II trials. Enriching randomized trials for biomarker-positive patients can markedly reduce required patient numbers and costs despite expensive screening for biomarker-positive patients. Available data support approval of new drugs without randomized trials if they yield

  16. The quality of randomized controlled trial reporting in spine literature.

    Science.gov (United States)

    Naunheim, Matthew R; Walcott, Brian P; Nahed, Brian V; Simpson, Andrew K; Agarwalla, Pankaj K; Coumans, Jean-Valery

    2011-07-15

    Retrospective literature review. To assess the quality of randomized controlled trial reporting in spine surgery. The use of the Consolidated Standards of Reporting Trials (CONSORT) criteria in clinical trials aims to improve adherence to a set of generally accepted practices in the reporting of randomized controlled trials. Randomized controlled trials in spine surgery are important sources of evidence-based practice, but the quality of their execution and reporting have not been reported adequately. All randomized controlled trials published in three selected dedicated spine journals from 2008 were reviewed with respect to the 40 criteria derived from CONSORT descriptors; 10 criteria applying to the abstract, and 30 to the body of the article. Each article was scored by three reviewers in group format for each criterion and was assigned a score. Reviewers always came to a consensus before assigning a score. A total of 32 RCTs met the inclusion criteria for this review. The average modified CONSORT score was 65%. Disclosing certain criteria was associated with a higher overall score, including method of generation of random sequence (P spine literature may thus be difficult to interpret. Greater effort must be put into compliance with these guidelines to improve data quality.

  17. A Randomized controlled trial of intramuscular pentazocine ...

    African Journals Online (AJOL)

    pain perception was assessed using visual analog scale (VAS) scores at presentation and after delivery while maternal ... Randomized controlled trial of intramuscular pentazocine compared to intravenous paracetamol for pain relief in labour. 117. Tropical Journal of Obstetrics .... An envelope was opened by a nurse and.

  18. Study protocol: Cost effectiveness of two strategies to implement the NVOG guidelines on hypertension in pregnancy: An innovative strategy including a computerised decision support system compared to a common strategy of professional audit and feedback, a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Luitjes Susanne HE

    2010-09-01

    Full Text Available Abstract Background Hypertensive disease in pregnancy remains the leading cause of maternal mortality in the Netherlands. Seventeen percent of the clinical pregnancies are complicated by hypertension and 2% by preeclampsia. The Dutch Society of Obstetrics and Gynaecology (NVOG has developed evidence-based guidelines on the management of hypertension in pregnancy and chronic hypertension. Previous studies showed a low adherence rate to other NVOG guidelines and a large variation in usual care in the different hospitals. An explanation is that the NVOG has no general strategy of practical implementation and evaluation of its guidelines. The development of an effective and cost effective implementation strategy to improve adherence to the guidelines on hypertension in pregnancy is needed. Methods/Design The objective of this study is to assess the cost effectiveness of an innovative implementation strategy of the NVOG guidelines on hypertension including a computerised decision support system (BOS compared to a common strategy of professional audit and feedback. A cluster randomised controlled trial with an economic evaluation alongside will be performed. Both pregnant women who develop severe hypertension or pre-eclampsia and professionals involved in the care for these women will participate. The main outcome measures are a combined rate of major maternal complications and process indicators extracted from the guidelines. A total of 472 patients will be included in both groups. For analysis, descriptive as well as regression techniques will be used. A cost effectiveness and cost utility analysis will be performed according to the intention-to-treat principle and from a societal perspective. Cost effectiveness ratios will be calculated using bootstrapping techniques.

  19. Blinding in randomized clinical trials: imposed impartiality

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Boutron, I

    2011-01-01

    Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations...... and empirical analyses support the blinding of patients, health-care providers, and outcome assessors as to the trial intervention to which patients have been allocated. We encourage extensive pretrial testing of blinding procedures and explicit reporting of who was in the blinded condition and the methods used...

  20. Design of a cluster-randomized minority recruitment trial: RECRUIT.

    Science.gov (United States)

    Tilley, Barbara C; Mainous, Arch G; Smith, Daniel W; McKee, M Diane; Amorrortu, Rossybelle P; Alvidrez, Jennifer; Diaz, Vanessa; Ford, Marvella E; Fernandez, Maria E; Hauser, Robert A; Singer, Carlos; Landa, Veronica; Trevino, Aron; DeSantis, Stacia M; Zhang, Yefei; Daniels, Elvan; Tabor, Derrick; Vernon, Sally W

    2017-06-01

    Racial/ethnic minority groups remain underrepresented in clinical trials. Many strategies to increase minority recruitment focus on minority communities and emphasize common diseases such as hypertension. Scant literature focuses on minority recruitment to trials of less common conditions, often conducted in specialty clinics and dependent on physician referrals. We identified trust/mistrust of specialist physician investigators and institutions conducting medical research and consequent participant reluctance to participate in clinical trials as key-shared barriers across racial/ethnic groups. We developed a trust-based continuous quality improvement intervention to build trust between specialist physician investigators and community minority-serving physicians and ultimately potential trial participants. To avoid the inherent biases of non-randomized studies, we evaluated the intervention in the national Randomized Recruitment Intervention Trial (RECRUIT). This report presents the design of RECRUIT. Specialty clinic follow-up continues through April 2017. We hypothesized that specialist physician investigators and coordinators trained in the trust-based continuous quality improvement intervention would enroll a greater proportion of minority participants in their specialty clinics than specialist physician investigators in control specialty clinics. Specialty clinic was the unit of randomization. Using continuous quality improvement, the specialist physician investigators and coordinators tailored recruitment approaches to their specialty clinic characteristics and populations. Primary analyses were adjusted for clustering by specialty clinic within parent trial and matching covariates. RECRUIT was implemented in four multi-site clinical trials (parent trials) supported by three National Institutes of Health institutes and included 50 associated specialty clinics from these parent trials. Using current data, we have 88% power or greater to detect a 0.15 or

  1. 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

    evaluated in the eligible trials. RESULTS: Thirty-five eligible trials were identified. The majority of them were conducted in Asia, used community as randomization unit, and had less than 10,000 participants. To minimize confounding, 23 of the 35 trials had stratified, blocked, or paired the clusters...... before they were randomized, while 17 had adjusted for confounding in the analysis. Ten of the 35 trials did not account for clustering in sample size calculations, and seven did not account for the cluster-randomized design in the analysis. The number of cluster-randomized trials increased over time......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...

  2. [Ethical aspects of randomized clinical trials].

    Science.gov (United States)

    Bartoli, E; Sorrentino, D; Trevisi, A

    1997-01-01

    Randomized clinical trials represent the final, essential link between basic medical research and human health. However, their conduction presents very complex ethical problems, since the patient is the actual target of the experiment. Proper randomization, informed consent, and preliminary disclosure of results create deep ethical conflicts between the role of caretaker and that of impartial observer, both played by the same doctor. The dilemma reproduces the conflict between two different ethics. One is based on the inalienable individual rights stemming from the concept of man as an end in himself and not a means to an end. The other, derived from utilitarian philosophies, is based on the benefit for society as a whole. If we agree that randomized clinical trials represent the best method to test the validity of a new treatment, there is no easy solution. The dilemma could be solved by separating the role of the family doctor, committed to the best treatment possible for his patient, from the role of the scientist, committed to the progress of science and humanity. The former is involved in the treatment of individual patients, the latter in clinical and scientific experiments of a therapeutic nature. The patient may trade his rights to the best possible cure for the safety and the efficiency guaranteed by the scientific institution conducting the trial. Trials on relevant issues--expected to produce important results and impeccably designed scientifically--could be endowed with the ethics of science per se and this could be considered equivalent to the individual rights waived by the patient.

  3. The pursuit of balance: An overview of covariate-adaptive randomization techniques in clinical trials.

    Science.gov (United States)

    Lin, Yunzhi; Zhu, Ming; Su, Zheng

    2015-11-01

    Randomization is fundamental to the design and conduct of clinical trials. Simple randomization ensures independence among subject treatment assignments and prevents potential selection biases, yet it does not guarantee balance in covariate distributions across treatment groups. Ensuring balance in important prognostic covariates across treatment groups is desirable for many reasons. A broad class of randomization methods for achieving balance are reviewed in this paper; these include block randomization, stratified randomization, minimization, and dynamic hierarchical randomization. Practical considerations arising from experience with using the techniques are described. A review of randomization methods used in practice in recent randomized clinical trials is also provided. Copyright © 2015 Elsevier Inc. All rights reserved.

  4. Recent randomized controlled trials in otolaryngology.

    Science.gov (United States)

    Banglawala, Sarfaraz M; Lawrence, Lauren A; Franko-Tobin, Emily; Soler, Zachary M; Schlosser, Rodney J; Ioannidis, John

    2015-03-01

    To assess recent trends in the prevalence and quality of reporting of randomized controlled trials (RCTs) in 4 otolaryngology journals. Methodology and reporting analysis. Randomized controlled trials in 4 otolaryngology journals. All RCTs published from 2011 to 2013 in 4 major otolaryngology journals were examined for characteristics of study design, quality of design and reporting, and funding. Of 5279 articles published in 4 leading otolaryngology journals from 2011 to 2013, 189 (3.3%) were RCTs. The majority of RCTs were clinical studies (86%), with the largest proportion consisting of sinonasal topics (31%). Most interventions were medical (46%), followed by surgical (38%) and mixed (16%). In terms of quality, randomization method was reported in 54% of RCTs, blinding in 33%, and adverse events in 65%. Intention-to-treat analysis was used in 32%; P values were reported in 87% and confidence intervals in 10%. Research funding was most often absent or not reported (55%), followed by not-for-profit (25%). Based on review of 4 otolaryngology journals, RCTs are still a small proportion of all published studies in the field of otolaryngology. There seem to be trends toward improvement in quality of design and reporting of RCTs, although many quality features remain suboptimal. Practitioners both designing and interpreting RCTs should critically evaluate RCTs for quality. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014.

  5. Empirical likelihood inference in randomized clinical trials.

    Science.gov (United States)

    Zhang, Biao

    2017-01-01

    In individually randomized controlled trials, in addition to the primary outcome, information is often available on a number of covariates prior to randomization. This information is frequently utilized to undertake adjustment for baseline characteristics in order to increase precision of the estimation of average treatment effects; such adjustment is usually performed via covariate adjustment in outcome regression models. Although the use of covariate adjustment is widely seen as desirable for making treatment effect estimates more precise and the corresponding hypothesis tests more powerful, there are considerable concerns that objective inference in randomized clinical trials can potentially be compromised. In this paper, we study an empirical likelihood approach to covariate adjustment and propose two unbiased estimating functions that automatically decouple evaluation of average treatment effects from regression modeling of covariate-outcome relationships. The resulting empirical likelihood estimator of the average treatment effect is as efficient as the existing efficient adjusted estimators(1) when separate treatment-specific working regression models are correctly specified, yet are at least as efficient as the existing efficient adjusted estimators(1) for any given treatment-specific working regression models whether or not they coincide with the true treatment-specific covariate-outcome relationships. We present a simulation study to compare the finite sample performance of various methods along with some results on analysis of a data set from an HIV clinical trial. The simulation results indicate that the proposed empirical likelihood approach is more efficient and powerful than its competitors when the working covariate-outcome relationships by treatment status are misspecified.

  6. Inadequate description of educational interventions in ongoing randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Pino Cécile

    2012-05-01

    Full Text Available Abstract Background The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs of patient education. Methods On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers. Results We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%. The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47% or active treatment (47%. A minority of records (17%, 95% CI 11 to 23% reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention. Further, for most reports (59%, important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63

  7. COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer

    DEFF Research Database (Denmark)

    Buunen, M; Bonjer, H J; Hop, W C J

    2009-01-01

    INTRODUCTION: Laparoscopic resection of rectal cancer has been proven efficacious but morbidity and oncological outcome need to be investigated in a randomized clinical trial. Trial design: Non-inferiority randomized clinical trial. METHODS: The COLOR II trial is an ongoing international randomized...... clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy...

  8. Acupuncture in Patients with Allergic Asthma: A Randomized Pragmatic Trial.

    Science.gov (United States)

    Brinkhaus, Benno; Roll, Stephanie; Jena, Susanne; Icke, Katja; Adam, Daniela; Binting, Sylvia; Lotz, Fabian; Willich, Stefan N; Witt, Claudia M

    2017-04-01

    Although the available evidence is insufficient, acupuncture is used in patients suffering from chronic asthma. The aim of this pragmatic study was to investigate the effectiveness of acupuncture in addition to routine care in patients with allergic asthma compared to treatment with routine care alone. Patients with allergic asthma were included in a randomized controlled trial and randomized to receive up to 15 acupuncture sessions over 3 months or to a control group receiving routine care alone. Patients who did not consent to randomization received acupuncture treatment for the first 3 months and were followed as a cohort. All trial patients were allowed to receive routine care in addition to study treatment. The primary endpoint was the asthma quality of life questionnaire (AQLQ, range: 1-7) at 3 months. Secondary endpoints included general health related to quality of life (Short-Form-36, SF-36, range 0-100). Outcome parameters were assessed at baseline and at 3 and 6 months. A total of 1,445 patients (mean age 43.8 [SD 13.5] years, 58.7% female) were randomized and included in the analysis (184 patients randomized to acupuncture and 173 to control, and 1,088 in the nonrandomized acupuncture group). In the randomized part, acupuncture was associated with an improvement in the AQLQ score compared to the control group (difference acupuncture vs. control group 0.7 [95% confidence interval (CI) 0.5-1.0]) as well as in the physical component scale and the mental component scale of the SF-36 (physical: 2.5 [1.0-4.0]; mental 4.0 [2.1-6.0]) after 3 months. Treatment success was maintained throughout 6 months. Patients not consenting to randomization showed similar improvements as the randomized acupuncture group. In patients with allergic asthma, additional acupuncture treatment to routine care was associated with increased disease-specific and health-related quality of life compared to treatment with routine care alone.

  9. Mobile access to virtual randomization for investigator-initiated trials.

    Science.gov (United States)

    Deserno, Thomas M; Keszei, András P

    2017-08-01

    Background/aims Randomization is indispensable in clinical trials in order to provide unbiased treatment allocation and a valid statistical inference. Improper handling of allocation lists can be avoided using central systems, for example, human-based services. However, central systems are unaffordable for investigator-initiated trials and might be inaccessible from some places, where study subjects need allocations. We propose mobile access to virtual randomization, where the randomization lists are non-existent and the appropriate allocation is computed on demand. Methods The core of the system architecture is an electronic data capture system or a clinical trial management system, which is extended by an R interface connecting the R server using the Java R Interface. Mobile devices communicate via the representational state transfer web services. Furthermore, a simple web-based setup allows configuring the appropriate statistics by non-statisticians. Our comprehensive R script supports simple randomization, restricted randomization using a random allocation rule, block randomization, and stratified randomization for un-blinded, single-blinded, and double-blinded trials. For each trial, the electronic data capture system or the clinical trial management system stores the randomization parameters and the subject assignments. Results Apps are provided for iOS and Android and subjects are randomized using smartphones. After logging onto the system, the user selects the trial and the subject, and the allocation number and treatment arm are displayed instantaneously and stored in the core system. So far, 156 subjects have been allocated from mobile devices serving five investigator-initiated trials. Conclusion Transforming pre-printed allocation lists into virtual ones ensures the correct conduct of trials and guarantees a strictly sequential processing in all trial sites. Covering 88% of all randomization models that are used in recent trials, virtual randomization

  10. Risk of bias in randomized trials of pharmacological interventions in children and adults.

    Science.gov (United States)

    Sinha, Yashwant K; Craig, Jonathan C; Sureshkumar, Premala; Hayen, Andrew; Brien, Jo-anne E

    2014-08-01

    To determine whether randomized controlled trials of pharmacologic interventions in children are more likely to be biased than similar trials in adults. Trials involving only children and published in MEDLINE between January 2008 and October 2009 (n=100) were randomly selected and matched, by drug class and therapeutic area, with a similar trial completed in adults. The Cochrane risk of bias tool was used to compare the pediatric and adult trials. The characteristics of adult and pediatric trials included were similar, except that adult studies were more likely to be conducted in Europe and published in specialty journals. Two-thirds of all trials were single center, and 62% had 100 or fewer participants. Many trials had an unclear risk of bias for allocation concealment (65% adult, 52% pediatric). More pediatric trials had a low risk of bias for random sequence generation (59% pediatric, 41% adult, P=.002) and blinding of outcome assessment (63% pediatric, 48% adult, P=.04) than adult trials; however, a sensitivity analysis of trials published since 2008 (and so matched by year of publication) did not confirm this finding, suggesting year of publication was an important confounder. When randomized controlled trials are matched for drug class and therapeutic area, trials involving children display a similar risk of bias. Differences in the risk of bias between pediatric and adult trials are not caused by differences in the capacity of researchers to conduct and report trials of high quality. Copyright © 2014 Elsevier Inc. All rights reserved.

  11. Randomized Controlled Trials of Add-On Antidepressants in Schizophrenia.

    Science.gov (United States)

    Terevnikov, Viacheslav; Joffe, Grigori; Stenberg, Jan-Henry

    2015-05-19

    Despite adequate treatment with antipsychotics, a substantial number of patients with schizophrenia demonstrate only suboptimal clinical outcome. To overcome this challenge, various psychopharmacological combination strategies have been used, including antidepressants added to antipsychotics. To analyze the efficacy of add-on antidepressants for the treatment of negative, positive, cognitive, depressive, and antipsychotic-induced extrapyramidal symptoms in schizophrenia, published randomized controlled trials assessing the efficacy of adjunctive antidepressants in schizophrenia were reviewed using the following parameters: baseline clinical characteristics and number of patients, their on-going antipsychotic treatment, dosage of the add-on antidepressants, duration of the trial, efficacy measures, and outcomes. There were 36 randomized controlled trials reported in 41 journal publications (n=1582). The antidepressants used were the selective serotonin reuptake inhibitors, duloxetine, imipramine, mianserin, mirtazapine, nefazodone, reboxetin, trazodone, and bupropion. Mirtazapine and mianserin showed somewhat consistent efficacy for negative symptoms and both seemed to enhance neurocognition. Trazodone and nefazodone appeared to improve the antipsychotics-induced extrapyramidal symptoms. Imipramine and duloxetine tended to improve depressive symptoms. No clear evidence supporting selective serotonin reuptake inhibitors' efficacy on any clinical domain of schizophrenia was found. Add-on antidepressants did not worsen psychosis. Despite a substantial number of randomized controlled trials, the overall efficacy of add-on antidepressants in schizophrenia remains uncertain mainly due to methodological issues. Some differences in efficacy on several schizophrenia domains seem, however, to exist and to vary by the antidepressant subgroups--plausibly due to differences in the mechanisms of action. Antidepressants may not worsen the course of psychosis. Better designed

  12. Randomized clinical trial: group counseling based on tinnitus retraining therapy

    National Research Council Canada - National Science Library

    Henry, James A; Loovis, Carl; Montero, Melissa; Kaelin, Christine; Anselmi, Kathryn-Anne; Coombs, Rebecca; Hensley, June; James, Kenneth E

    2007-01-01

    .... We conducted a randomized clinical trial to test the hypothesis that group educational counseling based on TRT principles would effectively treat veterans who have clinically significant tinnitus...

  13. The value of including spirometry in health checks - a randomized controlled study in primary health care

    DEFF Research Database (Denmark)

    Ørts, Lene Maria; Ottesen, Anders Løkke; Bjerregaard, Anne-Louise

    Background Lung diseases are among the most frequent and most serious ailments in Denmark. Preventive health checks including spirometry can be used to detect lung diseases earlier. Over time the attendance at preventive health checks has decreased and at present the response rate is approximately...... 50%. Little is known about initiatives that can influence the attendance rate. Objectives To examine whether focused information on spirometry in the invitation material will influence the attendance in preventive health checks. Materiel/Methods Design: A randomized controlled study on information...... on spirometry embedded in “Check your health Prevention Program, CHPP” from 2015-16. CHPP is a house-hold cluster randomized controlled trial offering a preventive health check to 30-49 year olds in a Danish municipality during the years 2012 through to 2017 (n= 26,216), carried out in collaboration between...

  14. Antibiotics for human toxoplasmosis: a systematic review of randomized trials.

    Science.gov (United States)

    Rajapakse, Senaka; Chrishan Shivanthan, Mitrakrishnan; Samaranayake, Nilakshi; Rodrigo, Chaturaka; Deepika Fernando, Sumadhya

    2013-06-01

    The efficacy of different treatment regimens in clinical syndromes of toxoplasmosis were assessed by conducting a systematic review of published randomized clinical trials through extensive searches in MEDLINE, EMBASE, and SCOPUS with no date limits, as well as manual review of journals. Outcome measures varied depending on the clinical entity of toxoplasmosis. Risk of bias was evaluated and quality of evidence was graded. Fourteen randomized trials were included of which one was a non-comparative study. One well-designed trial showed that trimethoprim-sulphamethoxazole was more effective than placebo for clinical recovery of toxoplasmic lymphadenopathy in immunocompetent hosts. For toxoplasmic encephalopathy, efficacy of pyrimethamine+sulphadiazine and trimethoprim+sulphamethoxazole were similar, whereas pyrimethamine+sulphadiazine versus pyrimathamine+clindamycin showed no difference, irrespective of the outcome. Intravitreal clindamycin+dexamethasone and conventional treatment with oral pyrimethamine+sulphadiazine had similar efficacy with regard to all outcome measures in ocular toxoplasmosis, and intravitreal therapy was found to be safe. Adverse effects seemed more common with pyrimethamine+sulphadiazine. Most trials for encephalitis and ocular manifestations had a high risk of bias and were of poor methodological quality. There were no trials evaluating drugs for toxoplasmosis in pregnancy, or for congenital toxoplasmosis. Pyrimethamine+sulphadiazine is an effective therapy for treatment of toxoplasmic encephalitis; trimethoprim+sulphamethoxazole and pyrimethamine+clindamycin are possible alternatives. Treatment with either oral or intravitreal antibiotics seems reasonable for ocular toxoplasmosis. Overall, trial evidence for the efficacy of these drugs for toxoplasmosis is poor, and further well-designed trials are needed.

  15. Complementary feeding: a Global Network cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Pasha Omrana

    2011-01-01

    Full Text Available Abstract Background Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated. Methods/Design A cluster randomized efficacy trial was designed to test the hypothesis that 12 months of daily intake of beef added as a complementary food would result in greater linear growth velocity than a micronutrient fortified equi-caloric rice-soy cereal supplement. The study is being conducted in 4 sites of the Global Network for Women's and Children's Health Research located in Guatemala, Pakistan, Democratic Republic of the Congo (DRC and Zambia in communities with toddler stunting rates of at least 20%. Five clusters per country were randomized to each of the food arms, with 30 infants in each cluster. The daily meat or cereal supplement was delivered to the home by community coordinators, starting when the infants were 6 months of age and continuing through 18 months. All participating mothers received nutrition education messages to enhance complementary feeding practices delivered by study coordinators and through posters at the local health center. Outcome measures, obtained at 6, 9, 12, and 18 months by a separate assessment team, included anthropometry; dietary variety and diversity scores; biomarkers of iron, zinc and Vitamin B12 status (18 months; neurocognitive development (12 and 18 months; and incidence of infectious morbidity throughout the trial. The trial was supervised by a trial steering committee, and an independent data monitoring committee provided oversight for the safety and conduct of the trial. Discussion Findings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will

  16. Maximin Optimal Designs for Cluster Randomized Trials

    Science.gov (United States)

    Wu, Sheng; Wong, Weng Kee; Crespi, Catherine M.

    2017-01-01

    Summary We consider design issues for cluster randomized trials (CRTs) with a binary outcome where both unit costs and intraclass correlation coefficients (ICCs) in the two arms may be unequal. We first propose a design that maximizes cost efficiency (CE), defined as the ratio of the precision of the efficacy measure to the study cost. Because such designs can be highly sensitive to the unknown ICCs and the anticipated success rates in the two arms, a local strategy based on a single set of best guesses for the ICCs and success rates can be risky. To mitigate this issue, we propose a maximin optimal design that permits ranges of values to be specified for the success rate and the ICC in each arm. We derive maximin optimal designs for three common measures of the efficacy of the intervention, risk difference, relative risk and odds ratio, and study their properties. Using a real cancer control and prevention trial example, we ascertain the efficiency of the widely used balanced design relative to the maximin optimal design and show that the former can be quite inefficient and less robust to mis-specifications of the ICCs and the success rates in the two arms. PMID:28182835

  17. Perspectives on randomized clinical trials : the case for albuminuria

    NARCIS (Netherlands)

    Lambers Heerspink, Hiddo Jan

    2008-01-01

    Large scale randomized clinical trials are needed to detect small but meaningful effects of new drugs. However, large scale randomized clinical trials are expensive undertakings and they are in imbalance with the scientific output. As a consequence there is a strong voice for more efficacious

  18. Cavity lining after excavating caries lesions: meta-analysis and trial sequential analysis of randomized clinical trials.

    Science.gov (United States)

    Schwendicke, Falk; Göstemeyer, Gerd; Gluud, Christian

    2015-11-01

    After removal of dentine caries lesions, cavity lining has been advocated. Non-clinical data support this approach, but clinical data are sparse and ambiguous. We aimed at evaluating the benefits and harms of cavity lining using meta-analysis and Trial Sequential Analysis. We included randomized clinical trials comparing restorations without versus with cavity lining for treating primary caries lesions. Only trials reporting failure (defined as need to re-retreat) after ≥1 year follow-up were included. Trial selection, data extraction, and risk of bias assessment were conducted independently by two reviewers. We conducted random-effects intention-to-treat and per-protocol meta-analyses, and Trial Sequential Analysis to control for random errors. Electronic databases (PubMed, Embase, CENTRAL) were systematically screened, and hand searches and cross-referencing performed. From 128 studies, three randomized trials (89/130 patients or teeth), all treating primary teeth, were included. The trials had high risk of bias. All trials compared no lining versus calcium hydroxide lining after selective caries removal followed by adhesive restoration. Follow-up was 36 to 53 months. Restoring the cavity without lining did not significantly affect the risk of failure (intention-to-treat relative risk (RR) (95% confidence interval) 0.71 (0.49-1.04), per-protocol RR 0.52 (0.24-1.10). According to Trial Sequential Analysis, no firm evidence was reached. The quality of evidence was very low. Strong recommendations for using cavity liners are unsubstantiated, but firm evidence for omitting lining is also unavailable. Our findings apply only to primary teeth and calcium hydroxide liner. Whilst lining is frequently performed in dental practice, very few randomized clinical trials investigated this issue. The three trials included in this review treated deciduous teeth and did not find lining with calcium hydroxide beneficial. Lining is not supported by sufficient clinical evidence

  19. Cupping therapy for acute and chronic pain management: a systematic review of randomized clinical trials

    OpenAIRE

    Cao, Huijuan; Li, Xun; Yan, Xue; Wang, Nissi S.; Bensoussan, Alan; Liu, Jianping

    2014-01-01

    Objective: Cupping as a traditional therapy is used to treat a myriad of health conditions, including pain. This systematic review assessed the effectiveness and safety of cupping for different types of pain. Methods: Thirteen databases and four trial registries were searched for randomized clinical trials. Meta-analysis of data was conducted if there was non-significant clinical and statistical heterogeneity (measured by I2 test) among trials. Results: Sixteen trials with 921 participa...

  20. Sample size calculations for 3-level cluster randomized trials

    NARCIS (Netherlands)

    Teerenstra, S.; Moerbeek, M.; Achterberg, T. van; Pelzer, B.J.; Borm, G.F.

    2008-01-01

    BACKGROUND: The first applications of cluster randomized trials with three instead of two levels are beginning to appear in health research, for instance, in trials where different strategies to implement best-practice guidelines are compared. In such trials, the strategy is implemented in health

  1. Sample size calculations for 3-level cluster randomized trials

    NARCIS (Netherlands)

    Teerenstra, S.; Moerbeek, M.; Achterberg, T. van; Pelzer, B.J.; Borm, G.F.

    2008-01-01

    Background The first applications of cluster randomized trials with three instead of two levels are beginning to appear in health research, for instance, in trials where different strategies to implement best-practice guidelines are compared. In such trials, the strategy is implemented in health

  2. Assessing bias in osteoarthritis trials included in Cochrane reviews

    DEFF Research Database (Denmark)

    Hansen, Julie Bolvig; Juhl, Carsten Bogh; Boutron, Isabelle

    2014-01-01

    INTRODUCTION: The validity of systematic reviews and meta-analysis depends on methodological quality and unbiased dissemination of trials. Our objective is to evaluate the association of estimates of treatment effects with different bias-related study characteristics in meta-analyses of intervent......INTRODUCTION: The validity of systematic reviews and meta-analysis depends on methodological quality and unbiased dissemination of trials. Our objective is to evaluate the association of estimates of treatment effects with different bias-related study characteristics in meta......-analyses of interventions used for treating pain in osteoarthritis (OA). From the findings, we hope to consolidate guidance on interpreting OA trials in systematic reviews based on empirical evidence from Cochrane reviews. METHODS AND ANALYSIS: Only systematic reviews that compare experimental interventions with sham...... the first appearing forest plot for overall pain in the Cochrane review. Treatment effect sizes will be expressed as standardised mean differences (SMDs), where the difference in mean values available from the forest plots is divided by the pooled SD. To empirically assess the risk of bias in treatment...

  3. Ethical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems.

    Science.gov (United States)

    Anderson, Monique L; Califf, Robert M; Sugarman, Jeremy

    2015-06-01

    Cluster randomized trials randomly assign groups of individuals to examine research questions or test interventions and measure their effects on individuals. Recent emphasis on quality improvement, comparative effectiveness, and learning health systems has prompted expanded use of pragmatic cluster randomized trials in routine health-care settings, which in turn poses practical and ethical challenges that current oversight frameworks may not adequately address. The 2012 Ottawa Statement provides a basis for considering many issues related to pragmatic cluster randomized trials but challenges remain, including some arising from the current US research and health-care regulations. In order to examine the ethical, regulatory, and practical questions facing pragmatic cluster randomized trials in health-care settings, the National Institutes of Health Health Care Systems Research Collaboratory convened a workshop in Bethesda, Maryland, in July 2013. Attendees included experts in clinical trials, patient advocacy, research ethics, and research regulations from academia, industry, the National Institutes of Health Collaboratory, and other federal agencies. Workshop participants identified substantial barriers to implementing these types of cluster randomized trials, including issues related to research design, gatekeepers and governance in health systems, consent, institutional review boards, data monitoring, privacy, and special populations. We describe these barriers and suggest means for understanding and overcoming them to facilitate pragmatic cluster randomized trials in health-care settings. © The Author(s) 2015.

  4. Bayesian adaptive randomization in a clinical trial to identify new regimens for MDR-TB: the endTB trial.

    Science.gov (United States)

    Cellamare, M; Milstein, M; Ventz, S; Baudin, E; Trippa, L; Mitnick, C D

    2016-12-01

    Evidence-based optimization of treatment for multidrug-resistant tuberculosis (MDR-TB), including integration of new drugs, is urgent. Such optimization would benefit from efficient trial designs requiring fewer patients. Implementation of such innovative designs could accelerate improvements in and access to MDR-TB treatment. To describe the application, advantages, and challenges of Bayesian adaptive randomization in a Phase III non-inferiority trial of MDR-TB treatment. endTB is the first Phase III non-inferiority trial of MDR-TB treatment to use Bayesian adaptive randomization. We present a simulation study with assumptions for treatment response at 8, 39, and 73 weeks after randomization, on which sample size calculations are based. We show differences between Bayesian adaptive randomization and balanced randomization designs in sample size and number of patients exposed to ineffective regimens. With 750 participants, 27% fewer than required by balanced randomization, the study had 80% power to detect up to two (of five) novel treatment regimens that are non-inferior (margin 12%) to the control (70% estimated efficacy) at 73 weeks post randomization. Comparing Bayesian adaptive randomization to balanced randomization, up to 25% more participants would receive non-inferior regimens. Bayesian adaptive randomization may expose fewer participants to ineffective treatments and enhance the efficiency of MDR-TB treatment trials.

  5. What's in a title? An assessment of whether randomized controlled trial in a title means that it is one.

    Science.gov (United States)

    Koletsi, Despina; Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

    2012-06-01

    In this study, we aimed to investigate whether studies published in orthodontic journals and titled as randomized clinical trials are truly randomized clinical trials. A second objective was to explore the association of journal type and other publication characteristics on correct classification. American Journal of Orthodontics and Dentofacial Orthopedics, European Journal of Orthodontics, Angle Orthodontist, Journal of Orthodontics, Orthodontics and Craniofacial Research, World Journal of Orthodontics, Australian Orthodontic Journal, and Journal of Orofacial Orthopedics were hand searched for clinical trials labeled in the title as randomized from 1979 to July 2011. The data were analyzed by using descriptive statistics, and univariable and multivariable examinations of statistical associations via ordinal logistic regression modeling (proportional odds model). One hundred twelve trials were identified. Of the included trials, 33 (29.5%) were randomized clinical trials, 52 (46.4%) had an unclear status, and 27 (24.1%) were not randomized clinical trials. In the multivariable analysis among the included journal types, year of publication, number of authors, multicenter trial, and involvement of statistician were significant predictors of correctly classifying a study as a randomized clinical trial vs unclear and not a randomized clinical trial. From 112 clinical trials in the orthodontic literature labeled as randomized clinical trials, only 29.5% were identified as randomized clinical trials based on clear descriptions of appropriate random number generation and allocation concealment. The type of journal, involvement of a statistician, multicenter trials, greater numbers of authors, and publication year were associated with correct clinical trial classification. This study indicates the need of clear and accurate reporting of clinical trials and the need for educating investigators on randomized clinical trial methodology. Copyright © 2012 American Association

  6. Review of Randomized Controlled Trials of Massage in Preterm Infants

    Directory of Open Access Journals (Sweden)

    Anna-Kaisa Niemi

    2017-04-01

    Full Text Available Preterm birth affects about 10% of infants born in the United States. Massage therapy is being used in some neonatal intensive care units for its potential beneficial effects on preterm infants. This article reviews published randomized controlled trials on the effects of massage in preterm infants. Most studies evaluating the effect of massage in weight gain in premature infants suggest a positive effect on weight gain. Increase in vagal tone has been reported in infants who receive massage and has been suggested as a possible mechanism for improved weight gain. More studies are needed on the underlying mechanisms of the effects of massage therapy on weight gain in preterm infants. While some trials suggest improvements in developmental scores, decreased stress behavior, positive effects on immune system, improved pain tolerance and earlier discharge from the hospital, the number of such studies is small and further evidence is needed. Further studies, including randomized controlled trials, are needed on the effects of massage in preterm infants.

  7. Randomized controlled trials: still somewhat immature

    African Journals Online (AJOL)

    Adele

    2004-05-20

    May 20, 2004 ... cal trials were found to be eligible for recruitment to those studies.1 Looking at this issue from another perspective, fewer than fifteen percent of unselected patients attending a psychi- atric outpatient department clinic met eligibility criteria for inclusion into clinical trials.2,3 Results from clinical trials are.

  8. Randomized controlled trials for Alzheimer disease and Parkinson disease.

    Science.gov (United States)

    Lauretani, Fulvio; Ticinesi, Andrea; Meschi, Tiziana; Teresi, Giulio; Ceda, Gian Paolo; Maggio, Marcello

    2016-06-01

    The continuous increase in elderly and oldest-old population, and subsequent rise in prevalence of chronic neurological diseases like Alzheimer's disease (AD) and Parkinson's disease (PD), are a major challenge for healthcare systems. These two conditions are the most prevalent neurodegenerative diseases in older persons and physicians should engage treatment for these patients. In this field, Randomized Clinical Trials (RCTs) specifically focused on elderly populations are still lacking. The aim of this study was to identify RCTs conducted among AD and PD and to examine the difference between mean age of enrollment and incidence of these two neurodegenerative diseases. We found that the scenario is different between PD and AD. In particular, the enrollment for PD trials seems to include younger persons than AD, although the incidence of both diseases is similar and highest after 80 years old. The consequence of these results could influence conclusive guidelines of treatment in older parkinsonian patients.

  9. Uterine artery embolization vs hysterectomy in the treatment of symptomatic uterine fibroids : 10-year outcomes from the randomized EMMY trial

    NARCIS (Netherlands)

    de Bruijn, Annefleur M.; Ankum, Willem M.; Reekers, Jim A.; Birnie, Erwin; van der Kooij, Sanne M.; Volkers, Nicole A.; Hehenkamp, Wouter J. K.

    2016-01-01

    BACKGROUND: Since 1995 uterine artery embolization has been described as an alternative for hysterectomy in patients with symptomatic fibroids. Many studies including several randomized controlled trials established uterine artery embolization as a valuable treatment. These randomized controlled

  10. Laparoscopic versus open gastrectomy for gastric cancer, a multicenter prospectively randomized controlled trial (LOGICA-trial).

    Science.gov (United States)

    Haverkamp, Leonie; Brenkman, Hylke J F; Seesing, Maarten F J; Gisbertz, Suzanne S; van Berge Henegouwen, Mark I; Luyer, Misha D P; Nieuwenhuijzen, Grard A P; Wijnhoven, Bas P L; van Lanschot, Jan J B; de Steur, Wobbe O; Hartgrink, Henk H; Stoot, Jan H M B; Hulsewé, Karel W E; Spillenaar Bilgen, Ernst J; Rütter, Jeroen E; Kouwenhoven, Ewout A; van Det, Marc J; van der Peet, Donald L; Daams, Freek; Draaisma, Werner A; Broeders, Ivo A M J; van Stel, Henk F; Lacle, Miangela M; Ruurda, Jelle P; van Hillegersberg, Richard

    2015-07-29

    For gastric cancer patients, surgical resection with en-bloc lymphadenectomy is the cornerstone of curative treatment. Open gastrectomy has long been the preferred surgical approach worldwide. However, this procedure is associated with considerable morbidity. Several meta-analyses have shown an advantage in short-term outcomes of laparoscopic gastrectomy compared to open procedures, with similar oncologic outcomes. However, it remains unclear whether the results of these Asian studies can be extrapolated to the Western population. In this trial from the Netherlands, patients with resectable gastric cancer will be randomized to laparoscopic or open gastrectomy. The study is a non-blinded, multicenter, prospectively randomized controlled superiority trial. Patients (≥18 years) with histologically proven, surgically resectable (cT1-4a, N0-3b, M0) gastric adenocarcinoma and European Clinical Oncology Group performance status 0, 1 or 2 are eligible to participate in the study after obtaining informed consent. Patients (n = 210) will be included in one of the ten participating Dutch centers and are randomized to either laparoscopic or open gastrectomy. The primary outcome is postoperative hospital stay (days). Secondary outcome parameters include postoperative morbidity and mortality, oncologic outcomes, readmissions, quality of life and cost-effectiveness. In this randomized controlled trial laparoscopic and open gastrectomy are compared in patients with resectable gastric cancer. It is expected that laparoscopic gastrectomy will result in a faster recovery of the patient and a shorter hospital stay. Secondly, it is expected that laparoscopic gastrectomy will be associated with a lower postoperative morbidity, less readmissions, higher cost-effectiveness, better postoperative quality of life, but with similar mortality and oncologic outcomes, compared to open gastrectomy. The study started on 1 December 2014. Inclusion and follow-up will take 3 and 5

  11. Randomized controlled trials – a matter of design

    Directory of Open Access Journals (Sweden)

    Spieth PM

    2016-06-01

    Full Text Available Peter Markus Spieth,1,2 Anne Sophie Kubasch,3 Ana Isabel Penzlin,4 Ben Min-Woo Illigens,2,5 Kristian Barlinn,6 Timo Siepmann2,6,7 1Department of Anesthesiology and Critical Care Medicine, University Hospital Carl Gustav Carus, Technische Universität Dresden, 2Center for Clinical Research and Management Education, Division of Health Care Sciences, Dresden International University, 3Pediatric Rheumatology and Immunology, Children’s Hospital, University Hospital Carl Gustav Carus, Technische Universität Dresden, 4Institute of Clinical Pharmacology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Saxony, Germany; 5Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; 6Department of Neurology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Saxony, Germany; 7Radcliffe Department of Medicine, John Radcliffe Hospital, University of Oxford, Oxford, Oxfordshire, UK Abstract: Randomized controlled trials (RCTs are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1 clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2 both significant and nonsignificant results should be objectively

  12. Acupuncture for Posttraumatic Stress Disorder: A Systematic Review of Randomized Controlled Trials and Prospective Clinical Trials

    Directory of Open Access Journals (Sweden)

    Young-Dae Kim

    2013-01-01

    Full Text Available To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were “acupuncture” and “PTSD.” No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional therapy control for PTSD, or without control. Four randomized controlled trials (RCTs and 2 uncontrolled clinical trials (UCTs out of 136 articles in total were systematically reviewed. One high-quality RCT reported that acupuncture was superior to waitlist control and therapeutic effects of acupuncture and cognitive-behavioral therapy (CBT were similar based on the effect sizes. One RCT showed no statistical difference between acupuncture and selective serotonin reuptake inhibitors (SSRIs. One RCT reported a favorable effect of acupoint stimulation plus CBT against CBT alone. A meta-analysis of acupuncture plus moxibustion versus SSRI favored acupuncture plus moxibustion in three outcomes. This systematic review and meta-analysis suggest that the evidence of effectiveness of acupuncture for PTSD is encouraging but not cogent. Further qualified trials are needed to confirm whether acupuncture is effective for PTSD.

  13. Hallucination focused integrative treatment : A randomized controlled trial

    NARCIS (Netherlands)

    Jenner, JA; Nienhuis, FJ; Wiersma, D; van de Willige, G

    2004-01-01

    Improvements in psychopathology, subjective burden, and coping with voices after hallucination focused integrative treatment (HIT) were studied in chronic schizophrenic patients with persistent (> 10 years), drug-refractory auditory hallucinations. In a randomized controlled trial, routine care was

  14. Randomized clinical trial of laparoscopic versus open appendicectomy

    DEFF Research Database (Denmark)

    Pedersen, Allan Gorm; Petersen, O B; Wara, P

    2001-01-01

    BACKGROUND: Laparoscopy in patients with a clinical suspicion of acute appendicitis has not gained wide acceptance, and its use remains controversial. METHODS: In a randomized controlled trial of laparoscopic versus open appendicectomy, 583 of 828 consecutive patients consented to participate...

  15. Yoga for High‑Risk Pregnancy: A Randomized Controlled Trial ...

    African Journals Online (AJOL)

    Yoga for High‑Risk Pregnancy: A Randomized Controlled Trial. CS Deshpande, A Rakshani, R Nagarathna, TS Ganpat, A Kurpad, R Maskar, DC Sudheer, HR Nagendra, R Abbas, N Raghuram, K Anura, M Rita, NH Ramarao ...

  16. European randomized lung cancer screening trials: Post NLST

    DEFF Research Database (Denmark)

    Field, JK; Klaveren, R; Pedersen, JH

    2013-01-01

    Overview of the European randomized lung cancer CT screening trials (EUCT) is presented with regard to the implementation of CT screening in Europe; post NLST. All seven principal investigators completed a questionnaire on the epidemiological, radiological, and nodule management aspects...

  17. The Sexunzipped trial: young people's views of participating in an online randomized controlled trial.

    Science.gov (United States)

    Nicholas, Angela; Bailey, Julia V; Stevenson, Fiona; Murray, Elizabeth

    2013-12-12

    Incidence of sexually transmitted infections (STIs) among young people in the United Kingdom is increasing. The Internet can be a suitable medium for delivery of sexual health information and sexual health promotion, given its high usage among young people, its potential for creating a sense of anonymity, and ease of access. Online randomized controlled trials (RCTs) are increasingly being used to evaluate online interventions, but while there are many advantages to online methodologies, they can be associated with a number of problems, including poor engagement with online interventions, poor trial retention, and concerns about the validity of data collected through self-report online. We conducted an online feasibility trial that tested the effects of the Sexunzipped website for sexual health compared to an information-only website. This study reports on a qualitative evaluation of the trial procedures, describing participants' experiences and views of the Sexunzipped online trial including methods of recruitment, incentives, methods of contact, and sexual health outcome measurement. Our goal was to determine participants' views of the acceptability and validity of the online trial methodology used in the pilot RCT of the Sexunzipped intervention. We used three qualitative data sources to assess the acceptability and validity of the online pilot RCT methodology: (1) individual interviews with 22 participants from the pilot RCT, (2) 133 emails received by the trial coordinator from trial participants, and (3) 217 free-text comments from the baseline and follow-up questionnaires. Interviews were audio-recorded and transcribed verbatim. An iterative, thematic analysis of all three data sources was conducted to identify common themes related to the acceptability and feasibility of the online trial methodology. Interview participants found the trial design, including online recruitment via Facebook, online registration, email communication with the researchers, and

  18. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    , in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists...

  19. Randomized controlled trials: still somewhat immature

    African Journals Online (AJOL)

    Adele

    2004-05-20

    May 20, 2004 ... The conflict between the design of efficacy trials that give a reasonably sound answer to a very narrow question address- ing a very limited population and the design of effectiveness trials that evaluate complex questions in a more heterogeneous and “real world” population is one example. The former pro-.

  20. Mediterranean dietary pattern and depression: the PREDIMED randomized trial

    OpenAIRE

    S?nchez-Villegas, Almudena; Mart?nez-Gonz?lez, Miguel Angel; Estruch, Ram?n; Salas-Salvad?, Jordi; Corella, Dolores; Covas, Maria Isabel; Ar?s, Fernando; Romaguera, Dora; G?mez-Gracia, Enrique; Lapetra, Jos?; Pint?, Xavier; Mart?nez, Jose Alfredo; Lamuela-Ravent?s, Rosa Mar?a; Ros, Emilio; Gea, Alfredo

    2013-01-01

    BACKGROUND: A few observational studies have found an inverse association between adherence to a Mediterranean diet and the risk of depression. Randomized trials with an intervention based on this dietary pattern could provide the most definitive answer to the findings reported by observational studies. The aim of this study was to compare in a randomized trial the effects of two Mediterranean diets versus a low-fat diet on depression risk after at least 3 years of intervention. METHOD...

  1. Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial

    DEFF Research Database (Denmark)

    Kreiner, Frederik; Galbo, Henrik

    2010-01-01

    To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) a and the therapeutic potential of blockade with soluble TNF-a receptor, we carried out the first randomized controlled trial with etanercept in PMR.......To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) a and the therapeutic potential of blockade with soluble TNF-a receptor, we carried out the first randomized controlled trial with etanercept in PMR....

  2. Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial

    DEFF Research Database (Denmark)

    Kreiner, Frederik; Galbo, Henrik

    2010-01-01

    To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR.......To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR....

  3. Global Postural Reeducation for patients with musculoskeletal conditions: a systematic review of randomized controlled trials

    OpenAIRE

    Ferreira,Giovanni E.; Barreto,Rodrigo G. P.; Caroline C. Robinson; Rodrigo D. M. Plentz; Silva, Marcelo F.

    2016-01-01

    ABSTRACT Objectives To systematically review randomized controlled trials that assessed the effects of Global Postural Reeducation (GPR) on patient-reported outcomes in conditions of the musculoskeletal system. Method An electronic search of MEDLINE (via PubMed), EMBASE, Cochrane CENTRAL, and SciELO was performed from their inception to June 2015. Randomized controlled trials that analyzed pain and patient-reported outcomes were included in this review. The Cochrane Collaboration’s Ri...

  4. Hair removal policies in clean surgery: systematic review of randomized, controlled trials.

    Science.gov (United States)

    Niël-Weise, B S; Wille, J C; van den Broek, P J

    2005-12-01

    To determine whether certain hair removal policies are better than others to prevent surgical-site infections in patients undergoing clean surgery. Publications were retrieved by a systematic search of Medline, the Cochrane Library, and EMBASE up to February 2005. Additionally, the reference lists of all identified trials were examined. All randomized trials, quasi-randomized trials, and systematic reviews or meta-analyses of randomized or quasi-randomized trials comparing hair removal policies in clean surgery were selected. Trials involving patients undergoing cranial neurosurgery were excluded. Two reviewers independently assessed trial quality and extracted data. Disagreements were resolved by discussion with a third reviewer. Data from the original publications were used to calculate the relative risk or risk difference of surgical-site infection. Data for similar outcomes were combined in the analysis, where appropriate, with the use of a random effects model. Four trials were included in the review. No eligible systematic review or meta-analysis of randomized or quasi-randomized trials was found. The quality of the trials and how they were reported were generally unsatisfactory. Evidence regarding whether preoperative hair removal has any effect was inconclusive. When hair removal was considered necessary, evidence about the best time for removal was inconclusive. There was some evidence that hair removal by clipper is superior to removal by razor. Because of insufficient evidence as a basis for recommendations, the practical consequences for ward management were essential when the Dutch Working Party on Infection Prevention formulated its recommendations for hair removal policies. Large randomized, controlled trials are needed to determine the optimal policy for preoperative hair removal.

  5. Citation bias of hepato-biliary randomized clinical trials

    DEFF Research Database (Denmark)

    Kjaergard, Lise L; Gluud, Christian

    2002-01-01

    The objective of this study was to assess whether trials with a positive (i.e., statistically significant) outcome are cited more often than negative trials. We reviewed 530 randomized clinical trials on hepato-biliary diseases published in 11 English-language journals indexed in MEDLINE from 1985......-1996. From each trial, we extracted the statistical significance of the primary study outcome (positive or negative), the disease area, and methodological quality (randomization and double blinding). The number of citations during two calendar years after publication was obtained from Science Citation Index...... that positive trials are cited significantly more often than negative trials. The association was not explained by disease area or methodological quality....

  6. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Callahan Christopher M

    2012-06-01

    Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared

  7. Quality assessment of randomized clinical trial in intensive care.

    Science.gov (United States)

    Gonçalves, Giulliano Peixoto; Barbosa, Fabiano Timbó; Barbosa, Luciano Timbó; Duarte, José Lira

    2009-03-01

    A randomized clinical trial is a prospective study that compares the effect and value of interventions in human beings, of one or more groups vs. a control group. The objective of this study was to evaluate the quality of published randomized clinical trials in Intensive care in Brazil. All randomized clinical trials in intensive care found by manual search in Revista Brasileira de Terapia Intensiva from January 2001 to March 2008 were assessed to evaluate their description by the quality scale. Descriptive statistics and a 95 % confidence interval were used for the primary outcome. Our primary outcome was the randomized clinical trial quality. Our search found 185 original articles, of which 14 were randomized clinical trials. Only one original article (7.1%) showed good quality. There was no statistical significance between the collected data and the data shown in the hypothesis of this search. It can be concluded that in the sample of assessed articles 7% of the randomized clinical trials in intensive care published in a single intensive care journal in Brazil, present good methodological quality.

  8. Observer bias in randomized clinical trials with measurement scale outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida

    2013-01-01

    conducted a systematic review of randomized clinical trials with both blinded and nonblinded assessment of the same measurement scale outcome. We searched PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two...

  9. An Update on Randomized Clinical Trials in Breast Cancer.

    Science.gov (United States)

    Barnard, Kayla; Klimberg, V Suzanne

    2017-10-01

    Numerous clinical trials reveal new innovations and therapies that continually change the treatment and prevention of breast cancer. Earlier trials have changed the standard of care from radical mastectomy to breast conservation therapy and individualized treatment based on tumor-specific biology. As research continues and long-term follow-up results become available, updated reviews on randomized clinics trials become exceedingly important in discerning the most effective and oncologically safe therapies to provide optimal outcomes. Published by Elsevier Inc.

  10. Pragmatic design in randomized controlled trials.

    Science.gov (United States)

    Purgato, M; Barbui, C; Stroup, S; Adams, C

    2015-01-01

    At more than 10 years after the paper by Hotopf and colleagues regarding pragmatic trials in psychiatry, the field has evolved and is evolving further. There have been many developments in our understanding of what pragmatism really means, and excellent examples of truly pragmatic trials in psychiatry are currently available. Funders have helped encourage more emphasis on the need for such studies, but 'local' and trans-national regulations could help more. Consumers of the evidence should have a greater voice in generating the research agenda and, as this happens, the questions generated are more likely to be answered by a pragmatic approach to trials.

  11. Amantadine for dyskinesias in Parkinson's disease: a randomized controlled trial.

    Science.gov (United States)

    Sawada, Hideyuki; Oeda, Tomoko; Kuno, Sadako; Nomoto, Masahiro; Yamamoto, Kenji; Yamamoto, Mitsutoshi; Hisanaga, Kinya; Kawamura, Takashi

    2010-12-31

    Dyskinesias are some of the major motor complications that impair quality of life for patients with Parkinson's disease. The purpose of the present study was to investigate the efficacy of amantadine in Parkinson's disease patients suffering from dyskinesias. In this multi-center, double-blind, randomized, placebo-controlled, cross-over trial, 36 patients with Parkinson's disease and dyskinesias were randomized, and 62 interventions, which included amantadine (300 mg/day) or placebo treatment for 27 days, were analyzed. At 15 days after washout, the treatments were crossed over. The primary outcome measure was the changes in the Rush Dyskinesia Rating Scale (RDRS) during each treatment period. The secondary outcome measures were changes in the Unified Parkinson's Disease Rating Scale part IVa (UPDRS-IVa, dyskinesias), part IVb (motor fluctuations), and part III (motor function). RDRS improved in 64% and 16% of patients treated with amantadine or placebo, respectively, with significant differences between treatments. The adjusted odds-ratio for improvement by amantadine was 6.7 (95% confidence interval, 1.4 to 31.5). UPDRS-IVa was improved to a significantly greater degree in amantadine-treated patients [mean (SD) of 1.83 (1.56)] compared with placebo-treated patients [0.03 (1.51)]. However, there were no significant effects on UPDRS-IVb or III scores. Results from the present study demonstrated that amantadine exhibited efficacious effects against dyskinesias in 60-70% of patients. UMIN Clinical Trial Registry UMIN000000780.

  12. Reiki for the treatment of fibromyalgia: a randomized controlled trial.

    Science.gov (United States)

    Assefi, Nassim; Bogart, Andy; Goldberg, Jack; Buchwald, Dedra

    2008-11-01

    Fibromyalgia is a common, chronic pain condition for which patients frequently use complementary and alternative medicine, including Reiki. Our objective was to determine whether Reiki is beneficial as an adjunctive fibromyalgia treatment. This was a factorial designed, randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group. The study setting was private medical offices in the Seattle, Washington metropolitan area. The subjects were comprised 100 adults with fibromyalgia. Four (4) groups received twice-weekly treatment for 8 weeks by either a Reiki master or actor randomized to use direct touch or no touch (distant therapy). The primary outcome was subjective pain as measured by visual analog scale at weeks 4, 8, and 20 (3 months following end of treatment). Secondary outcomes were physical and mental functioning, medication use, and health provider visits. Participant blinding and adverse effects were ascertained by self-report. Improvement between groups was examined in an intention-to-treat analysis. Neither Reiki nor touch had any effect on pain or any of the secondary outcomes. All outcome measures were nearly identical among the 4 treatment groups during the course of the trial. Neither Reiki nor touch improved the symptoms of fibromyalgia. Energy medicine modalities such as Reiki should be rigorously studied before being recommended to patients with chronic pain symptoms.

  13. Exercise in Patients on Dialysis: A Multicenter, Randomized Clinical Trial.

    Science.gov (United States)

    Manfredini, Fabio; Mallamaci, Francesca; D'Arrigo, Graziella; Baggetta, Rossella; Bolignano, Davide; Torino, Claudia; Lamberti, Nicola; Bertoli, Silvio; Ciurlino, Daniele; Rocca-Rey, Lisa; Barillà, Antonio; Battaglia, Yuri; Rapanà, Renato Mario; Zuccalà, Alessandro; Bonanno, Graziella; Fatuzzo, Pasquale; Rapisarda, Francesco; Rastelli, Stefania; Fabrizi, Fabrizio; Messa, Piergiorgio; De Paola, Luciano; Lombardi, Luigi; Cupisti, Adamasco; Fuiano, Giorgio; Lucisano, Gaetano; Summaria, Chiara; Felisatti, Michele; Pozzato, Enrico; Malagoni, Anna Maria; Castellino, Pietro; Aucella, Filippo; Abd ElHafeez, Samar; Provenzano, Pasquale Fabio; Tripepi, Giovanni; Catizone, Luigi; Zoccali, Carmine

    2017-04-01

    Previous studies have suggested the benefits of physical exercise for patients on dialysis. We conducted the Exercise Introduction to Enhance Performance in Dialysis trial, a 6-month randomized, multicenter trial to test whether a simple, personalized walking exercise program at home, managed by dialysis staff, improves functional status in adult patients on dialysis. The main study outcomes included change in physical performance at 6 months, assessed by the 6-minute walking test and the five times sit-to-stand test, and in quality of life, assessed by the Kidney Disease Quality of Life Short Form (KDQOL-SF) questionnaire. We randomized 296 patients to normal physical activity (control; n=145) or walking exercise (n=151); 227 patients (exercise n=104; control n=123) repeated the 6-month evaluations. The distance covered during the 6-minute walking test improved in the exercise group (mean distance±SD: baseline, 328±96 m; 6 months, 367±113 m) but not in the control group (baseline, 321±107 m; 6 months, 324±116 m; Pquality of social interaction score (P=0.01) in the kidney disease component of the KDQOL-SF improved significantly in the exercise arm compared with the control arm. Hence, a simple, personalized, home-based, low-intensity exercise program managed by dialysis staff may improve physical performance and quality of life in patients on dialysis. Copyright © 2017 by the American Society of Nephrology.

  14. Randomized Trial of a Lifestyle Program in Obese Infertile Women

    NARCIS (Netherlands)

    Mutsaerts, Meike A. Q.; van Oers, Anne M.; Groen, Henk; Burggraaff, Jan M.; Kuchenbecker, Walter K. H.; Perquin, Denise A. M.; Koks, Carolien A. M.; van Golde, Ron; Kaaijk, Eugenie M.; Schierbeek, Jaap M.; Oosterhuis, Gerrit J. E.; Broekmans, Frank J.; Bemelmans, Wanda J. E.; Lambalk, Cornelis B.; Verberg, Marieke F. G.; van der Veen, Fulco; Klijn, Nicole F.; Mercelina, Patricia E. A. M.; van Kasteren, Yvonne M.; Nap, Annemiek W.; Brinkhuis, Egbert A.; Vogel, Niels E. A.; Mulder, Robert J. A. B.; Gondrie, Ed T. C. M.; de Bruin, Jan P.; Sikkema, J. Marko; de Greef, Mathieu H. G.; ter Bogt, Nancy C. W.; Land, Jolande A.; Mol, Ben W. J.; Hoek, Annemieke

    2016-01-01

    BACKGROUND Small lifestyle-intervention studies suggest that modest weight loss increases the chance of conception and may improve perinatal outcomes, but large randomized, controlled trials are lacking. METHODS We randomly assigned infertile women with a body-mass index (the weight in kilograms

  15. A note on Harold S. Diehl, randomization, and clinical trials.

    Science.gov (United States)

    Waller, L A

    1997-04-01

    Harold S. Diehl and coworkers published results from a remarkable trial on the efficacy of vaccines for the common cold in 1938. The original report states that patients were assigned to treatment and control groups "at random." Diehl's study has been referred to as one of the first instances of a randomized, double-blind, placebo-controlled trial. No description of a formal randomization scheme is given in the 1938 report and an unpublished paper of Diehl's suggests the use of alternate assignment in the study.

  16. Magnesium treatment in alcoholics: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Poikolainen Kari

    2008-01-01

    Full Text Available Abstract Background Magnesium (Mg deficiency is common among alcoholics. Earlier research suggests that Mg treatment may help to normalize elevated enzyme activities and some other clinically relevant parameters among alcoholics but the evidence is weak. Methods The effect of Mg was studied in a randomized, parallel group, double-blind trial. The patients were first treated for alcohol withdrawal symptoms and then received for 8 weeks either 500 mg of Mg divided into two tablets or matching placebo. Measurements were made at the beginning and in the end of the Mg treatment period. The primary outcome was serum gamma-glutamyltransferase (S-GGT activity; secondary outcomes included aspartate-aminotransferase (S-AST and alanine-aminotransferase (S-ALT activity. Results The number of randomized patients (completers was 64 (27 in the treatment and 54 (31 in the control group. In intention-to-treat-analyses and in most analyses of study completers, there were no significant differences between the Mg-treated and placebo groups in the outcome variables. When baseline serum Mg level, coffee intake, and the number of unused Mg tablets were controlled for in a multivariate regression model, after-treatment serum Mg levels were found to be higher among the Mg-treated group than in the placebo group (t-test 3.334, df = 53, p = 0.002. After controlling for age, body weight, baseline alcohol intake, subsequent change in alcohol intake and baseline S-AST, the after-treatment S-AST levels were found to be lower among the Mg-treated group than in the placebo group (t-test 2.061, df = 49, p = 0.045. Conclusion Mg treatment may speed up the S-AST decrease in compliant patients. This might decrease the risk of death from alcoholic liver disease. Trial Registration ClinicalTrials.gov ID NCT00325299

  17. Amantadine for dyskinesias in Parkinson's disease: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Hideyuki Sawada

    Full Text Available BACKGROUND: Dyskinesias are some of the major motor complications that impair quality of life for patients with Parkinson's disease. The purpose of the present study was to investigate the efficacy of amantadine in Parkinson's disease patients suffering from dyskinesias. METHODS: In this multi-center, double-blind, randomized, placebo-controlled, cross-over trial, 36 patients with Parkinson's disease and dyskinesias were randomized, and 62 interventions, which included amantadine (300 mg/day or placebo treatment for 27 days, were analyzed. At 15 days after washout, the treatments were crossed over. The primary outcome measure was the changes in the Rush Dyskinesia Rating Scale (RDRS during each treatment period. The secondary outcome measures were changes in the Unified Parkinson's Disease Rating Scale part IVa (UPDRS-IVa, dyskinesias, part IVb (motor fluctuations, and part III (motor function. RESULTS: RDRS improved in 64% and 16% of patients treated with amantadine or placebo, respectively, with significant differences between treatments. The adjusted odds-ratio for improvement by amantadine was 6.7 (95% confidence interval, 1.4 to 31.5. UPDRS-IVa was improved to a significantly greater degree in amantadine-treated patients [mean (SD of 1.83 (1.56] compared with placebo-treated patients [0.03 (1.51]. However, there were no significant effects on UPDRS-IVb or III scores. CONCLUSIONS: Results from the present study demonstrated that amantadine exhibited efficacious effects against dyskinesias in 60-70% of patients. TRIAL REGISTRATION: UMIN Clinical Trial Registry UMIN000000780.

  18. Management and conduct of randomized controlled trials.

    Science.gov (United States)

    Knatterud, Genell L

    2002-01-01

    In preparing to undertake a clinical trial, it may be helpful to keep in mind Fredrickson's description of clinical trials (31): "Field trials are indispensable. They will continue to be an ordeal. They lack glamour, they strain our resources and patience, and they protract the moment of truth to excruciating limits. Still, they are among the most challenging tests of our skills. I have no doubt that when the problem is well chosen, the study is appropriately designed, and that when all the populations concerned are made aware of the route and the goal, the reward can be commensurate with the effort. If, in major medical dilemmas, the alternative is to pay the costs of perpetual uncertainty, have we really any choice?"

  19. Clinical trials focusing on cancer pain educational interventions: core components to include during planning and reporting.

    Science.gov (United States)

    Stiles, Carla R; Biondo, Patricia D; Cummings, Greta; Hagen, Neil A

    2010-08-01

    Robust recommendations on the reporting of methods and results of clinical trials such as therapeutic intervention trials are widely used, such as the Consolidated Standards of Reporting Trials (CONSORT) recommendation. There has not been agreement on analogous publication standards for educational intervention trials, making interpretation of educational intervention studies difficult. The purpose of this report is to describe common deficiencies in reporting of educational intervention trials for cancer pain control, and to offer suggestions for authors to consider as they plan their studies, and report and publish research findings for educational interventions that use randomized controlled trials and other educational trial methodologies. A systematic review of published knowledge translation intervention trials intended to improve cancer pain was undertaken, of which most were educational interventions. Many educational intervention clinical trials designed to improve management of cancer pain appeared methodologically weak, and their results were more difficult to interpret because of reporting deficiencies. In the course of the review, patterns of deficiencies in reporting of methods and trial results were documented. Deficiencies in reporting were compared with the CONSORT recommendations for reporting clinical trials, and parallel recommendations were drafted for educational intervention trials. Patterns of deficiency in reporting cancer pain educational intervention trials were synthesized into seven domains, generically applicable to a range of study designs. Draft recommendations intended to address these deficiencies were constructed to improve communication of educational research results. Development of a standardized reporting template for clinical trials in cancer pain educational interventions could advance knowledge transfer research and thereby increase effectiveness of national and international cancer control policy designed to support cancer

  20. Can response-adaptive randomization increase participation in acute stroke trials?

    Science.gov (United States)

    Tehranisa, Jason S; Meurer, William J

    2014-07-01

    A response-adaptive randomization (RAR) trial design actively adjusts the ratio of participants assigned to each trial arm, favoring the better performing treatment by using outcome data from participants already in the trial. Compared with a standard clinical trial, an RAR study design has the potential to improve patient participation in acute stroke trials. This cross-sectional randomized survey included adult emergency department patients, age≥18, without symptoms of stroke or other critical illness. A standardized protocol was used, and subjects were randomized to either an RAR or standard hypothetical acute stroke trial. After viewing the video describing the hypothetical trial (http://youtu.be/cKIWduCaPZc), reviewing the consent form, and having questions answered, subjects indicated whether they would consent to the trial. A multivariable logistic regression model was fitted to estimate the impact of RAR while controlling for demographic factors and patient understanding of the design. A total of 418 subjects (210 standard and 208 RAR) were enrolled. All baseline characteristics were balanced between groups. There was significantly higher participation in the RAR trial (67.3%) versus the standard trial (54.5%), absolute increase: 12.8% (95% confidence interval, 3.7-22.2). The RAR group had a higher odds ratio of agreeing to research (odds ratio, 1.89; 95% confidence interval, 1.2-2.9) while adjusting for patient level factors. Trial designs were generally well understood by the participants. The hypothetical RAR trial attracted more research participation than standard randomization. RAR has the potential to increase recruitment and offer benefit to future trial participants. © 2014 American Heart Association, Inc.

  1. Efficacy of yoga for vasomotor symptoms: a randomized controlled trial.

    Science.gov (United States)

    Newton, Katherine M; Reed, Susan D; Guthrie, Katherine A; Sherman, Karen J; Booth-LaForce, Cathryn; Caan, Bette; Sternfeld, Barbara; Carpenter, Janet S; Learman, Lee A; Freeman, Ellen W; Cohen, Lee S; Joffe, Hadine; Anderson, Garnet L; Larson, Joseph C; Hunt, Julie R; Ensrud, Kristine E; LaCroix, Andrea Z

    2014-04-01

    This study aims to determine the efficacy of yoga in alleviating vasomotor symptoms (VMS) frequency and bother. This study was a three-by-two factorial, randomized controlled trial. Eligible women were randomized to yoga (n = 107), exercise (n = 106), or usual activity (n = 142), and were simultaneously randomized to a double-blind comparison of ω-3 fatty acid (n = 177) or placebo (n = 178) capsules. Yoga intervention consisted of 12 weekly 90-minute yoga classes with daily home practice. Primary outcomes were VMS frequency and bother assessed by daily diaries at baseline, 6 weeks, and 12 weeks. Secondary outcomes included insomnia symptoms (Insomnia Severity Index) at baseline and 12 weeks. Among 249 randomized women, 237 (95%) completed 12-week assessments. The mean baseline VMS frequency was 7.4 per day (95% CI, 6.6 to 8.1) in the yoga group and 8.0 per day (95% CI, 7.3 to 8.7) in the usual activity group. Intent-to-treat analyses included all participants with response data (n = 237). There was no difference between intervention groups in the change in VMS frequency from baseline to 6 and 12 weeks (mean difference [yoga--usual activity] from baseline at 6 wk, -0.3 [95% CI, -1.1 to 0.5]; mean difference [yoga--usual activity] from baseline at 12 wk, -0.3 [95% CI, -1.2 to 0.6]; P = 0.119 across both time points). Results were similar for VMS bother. At week 12, yoga was associated with an improvement in insomnia symptoms (mean difference [yoga - usual activity] in the change in Insomnia Severity Index, 1.3 [95% CI, -2.5 to -0.1]; P = 0.007). Among healthy women, 12 weeks of yoga class plus home practice, compared with usual activity, do not improve VMS frequency or bother but reduce insomnia symptoms.

  2. Targeting Functional Decline in Alzheimer Disease: A Randomized Trial.

    Science.gov (United States)

    Callahan, Christopher M; Boustani, Malaz A; Schmid, Arlene A; LaMantia, Michael A; Austrom, Mary G; Miller, Douglas K; Gao, Sujuan; Ferguson, Denisha Y; Lane, Kathleen A; Hendrie, Hugh C

    2017-02-07

    Alzheimer disease results in progressive functional decline, leading to loss of independence. To determine whether collaborative care plus 2 years of home-based occupational therapy delays functional decline. Randomized, controlled clinical trial. (ClinicalTrials.gov: NCT01314950). Urban public health system. 180 community-dwelling participants with Alzheimer disease and their informal caregivers. All participants received collaborative care for dementia. Patients in the intervention group also received in-home occupational therapy delivered in 24 sessions over 2 years. The primary outcome measure was the Alzheimer's Disease Cooperative Study Group Activities of Daily Living Scale (ADCS ADL); performance-based measures included the Short Physical Performance Battery (SPPB) and Short Portable Sarcopenia Measure (SPSM). At baseline, clinical characteristics did not differ significantly between groups; the mean Mini-Mental State Examination score for both groups was 19 (SD, 7). The intervention group received a median of 18 home visits from the study occupational therapists. In both groups, ADCS ADL scores declined over 24 months. At the primary end point of 24 months, ADCS ADL scores did not differ between groups (mean difference, 2.34 [95% CI, -5.27 to 9.96]). We also could not definitively demonstrate between-group differences in mean SPPB or SPSM values. The results of this trial are indeterminate and do not rule out potential clinically important effects of the intervention. The authors could not definitively demonstrate whether the addition of 2 years of in-home occupational therapy to a collaborative care management model slowed the rate of functional decline among persons with Alzheimer disease. This trial underscores the burden undertaken by caregivers as they provide care for family members with Alzheimer disease and the difficulty in slowing functional decline. National Institute on Aging.

  3. A pilot randomized controlled trial of EKG for neonatal resuscitation.

    Directory of Open Access Journals (Sweden)

    Anup Katheria

    Full Text Available The seventh edition of the American Academy of Pediatrics Neonatal Resuscitation Program recommends the use of a cardiac monitor in infants that need resuscitation. Previous trials have shown that EKG heart rate is available before pulse rate from a pulse oximeter. To date no trial has looked at how the availability of electrocardiogram (EKG affects clinical interventions in the delivery room.To determine whether the availability of an EKG heart rate value and tracing to the clinical team has an effect on physiologic measures and related interventions during the stabilization of preterm infants.Forty (40 premature infants enrolled in a neuro-monitoring study (The Neu-Prem Trial: NCT02605733 who had an EKG monitor available were randomized to have the heart rate information from the bedside EKG monitor either displayed or not displayed to the clinical team. Heart rate, oxygen saturation, FiO2 and mean airway pressure from a data acquisition system were recorded every 2 seconds. Results were averaged over 30 seconds and the differences analyzed using two-tailed t-test. Interventions analyzed included time to first change in FiO2, first positive pressure ventilation, first increase in airway pressure, and first intubation.There were no significant differences in time to clinical interventions between the blinded and unblinded group, despite the unblinded group having access to a visible heart rate at 66 +/- 20 compared to 114 +/- 39 seconds for the blinded group (p < .0001. Pulse rate from oximeter was lower than EKG heart rate during the first 2 minutes of life, but this was not significant.EKG provides an earlier, and more accurate heart rate than pulse rate from an oximeter during stabilization of preterm infants, allowing earlier intervention. All interventions were started earlier in the unblinded EKG group but these numbers were not significant in this small trial. Earlier EKG placement before pulse oximeter placement may affect other

  4. Naturopathic care for anxiety: a randomized controlled trial ISRCTN78958974.

    Science.gov (United States)

    Cooley, Kieran; Szczurko, Orest; Perri, Dan; Mills, Edward J; Bernhardt, Bob; Zhou, Qi; Seely, Dugald

    2009-08-31

    Anxiety is a serious personal health condition and represents a substantial burden to overall quality of life. Additionally anxiety disorders represent a significant cost to the health care system as well as employers through benefits coverage and days missed due to incapacity. This study sought to explore the effectiveness of naturopathic care on anxiety symptoms using a randomized trial. Employees with moderate to severe anxiety of longer than 6 weeks duration were randomized based on age and gender to receive naturopathic care (NC) (n = 41) or standardized psychotherapy intervention (PT) (n = 40) over a period of 12 weeks. Blinding of investigators and participants during randomization and allocation was maintained. Participants in the NC group received dietary counseling, deep breathing relaxation techniques, a standard multi-vitamin, and the herbal medicine, ashwagandha (Withania somnifera) (300 mg b.i.d. standardized to 1.5% with anolides, prepared from root). The PT intervention received psychotherapy, and matched deep breathing relaxation techniques, and placebo. The primary outcome measure was the Beck Anxiety Inventory (BAI) and secondary outcome measures included the Short Form 36 (SF-36), Fatigue Symptom Inventory (FSI), and Measure Yourself Medical Outcomes Profile (MY-MOP) to measure anxiety, mental health, and quality of life respectively. Participants were blinded to the placebo-controlled intervention. Seventy-five participants (93%) were followed for 8 or more weeks on the trial. Final BAI scores decreased by 56.5% (pbenefit. No serious adverse reactions were observed in either group. Many patients seek alternatives and/or complementary care to conventional anxiety treatments. To date, no study has evaluated the potential of a naturopathic treatment protocol to effectively treat anxiety. Knowledge of the efficacy, safety or risk of natural health products, and naturopathic treatments is important for physicians and the public in order to make

  5. Partner randomized controlled trial: study protocol and coaching intervention

    Directory of Open Access Journals (Sweden)

    Garbutt Jane M

    2012-04-01

    Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

  6. Trial registration in Latin America and the Caribbean's: study of randomized trials published in 2010.

    Science.gov (United States)

    Reveiz, Ludovic; Bonfill, Xavier; Glujovsky, Demian; Pinzon, Carlos E; Asenjo-Lobos, Claudia; Cortes, Marcela; Canon, Martin; Bardach, Ariel; Comandé, Daniel; Cardona, Andrés F

    2012-05-01

    To determine the prevalence of trial registration in randomized controlled trials (RCTs) published in 2010 (PUBMED/LILACS) from Latin America and the Caribbean's (LAC) and to compare methodological characteristics between registered and nonregistered RCTs. A search for detecting RCTs in which at least the first/contact author had a LAC's affiliation was made. We determined if RCTs were registered in the International Clinical Trial Registry Platform (ICTRP). Data were independently extracted by two authors. The risk of bias (RoB) was assessed in all registered RCTs (n=89) and in a sample of nonregistered RCTs (n=237). The search identified 1,695 references; 526 RCTs from 19 countries were included. 16.9% (89/526) of RCTs were registered in the ICTRP; however, only 21 (4.0%) were prospectively registered. A significant difference was found in the overall assessment of the RoB between registered and nonregistered RCTs. Overall, registered RCTs were multinational, had larger sample size and longer follow-up, and reported more frequently information on funding, conflict of interests, and ethic issues. No significant differences were found when analyzing prospectively registered RCTs. This study shows that trial registration rates are still low in LAC and the quality of reporting needs to be improved. Copyright © 2012 Elsevier Inc. All rights reserved.

  7. Antiplatelet treatments: recent evidence from randomized controlled trials.

    Science.gov (United States)

    Vogel, Birgit; Baber, Usman

    2017-07-01

    To provide an overview of selected randomized studies reported over the last 2 years evaluating antiplatelet therapies in patients with either acute or stable manifestations of atherosclerosis. From large outcome trials included evidence for reduced risk of ischemic events associated with use of ticagrelor and aspirin versus aspirin alone, albeit with an increased bleeding risk in patients with stable coronary artery disease and history of myocardial infarction. No benefit regarding ischemic outcomes could be demonstrated for ticagrelor monotherapy compared with aspirin or clopidogrel in patients with stroke or peripheral vascular disease, respectively. Results from pharmacokinetic/pharmacodynamic studies suggest that switching from prasugrel to ticagrelor is safe, regardless of the use of a loading dose, and that loading with prasugrel or ticagrelor compared with clopidogrel leads to more prompt and potent platelet inhibition in patients undergoing ad hoc percoutaneous coronary intervention. No evidence could be demonstrated for the prognostic value of routine platelet function monitoring to adjust antiplatelet therapy. Large outcome trials demonstrated various effects of antithrombotic strategies including ticagrelor on clinical outcomes across patient populations. Pharmacokinetic/pharmacodynamic studies confirmed a more prompt and potent platelet inhibition after loading with the new P2Y12 inhibitors versus clopidogrel, and suggested the safety of switching from prasugrel to ticagrelor.

  8. [Critical of the additive model of the randomized controlled trial].

    Science.gov (United States)

    Boussageon, Rémy; Gueyffier, François; Bejan-Angoulvant, Theodora; Felden-Dominiak, Géraldine

    2008-01-01

    Randomized, double-blind, placebo-controlled clinical trials are currently the best way to demonstrate the clinical effectiveness of drugs. Its methodology relies on the method of difference (John Stuart Mill), through which the observed difference between two groups (drug vs placebo) can be attributed to the pharmacological effect of the drug being tested. However, this additive model can be questioned in the event of statistical interactions between the pharmacological and the placebo effects. Evidence in different domains has shown that the placebo effect can influence the effect of the active principle. This article evaluates the methodological, clinical and epistemological consequences of this phenomenon. Topics treated include extrapolating results, accounting for heterogeneous results, demonstrating the existence of several factors in the placebo effect, the necessity to take these factors into account for given symptoms or pathologies, as well as the problem of the "specific" effect.

  9. Should We Still Believe in Randomized Controlled Trials in Nephrology?

    Science.gov (United States)

    Cortinovis, Monica; Perico, Norberto; Remuzzi, Giuseppe

    2017-01-01

    The randomized controlled trial (RCT) is the cornerstone upon which clinical decision-making is based. Pivotal RCTs in the nephrology area efficiently demonstrated the renoprotective effects of treatment with renin-angiotensin system inhibitors in patients with diabetic and non-diabetic proteinuric nephropathies. However, there is concern about the increasing cost, complexity and duration of clinical studies. Moreover, recent large RCTs addressing key issues for patients with renal disease failed to achieve definitive conclusions mainly due to critical flaws in the investigational strategies, including the adoption of excessive/fixed doses of the study medications, inappropriate use of the placebo-controlled design, enrollment of low-risk individuals, poor reporting of adverse events or unreliable evaluation of renal function. The information now available on the biases that characterize the current RCTs should serve as a tool to rethink the design, patient selection and implementation of future RCTs in nephrology. © 2016 S. Karger AG, Basel.

  10. Empirical evidence of study design biases in randomized trials

    DEFF Research Database (Denmark)

    Page, Matthew J.; Higgins, Julian P. T.; Clayton, Gemma

    2016-01-01

    search September 2012), and searched Ovid MEDLINE and Ovid EMBASE for studies indexed from Jan 2012-May 2015. Data were extracted by one author and verified by another. We combined estimates of average bias (e.g. ratio of odds ratios (ROR) or difference in standardised mean differences (dSMD)) in meta......-analyses using the random-effects model. Analyses were stratified by type of outcome ("mortality" versus "other objective" versus "subjective"). Direction of effect was standardised so that ROR ...) characteristic. Results: We included 24 studies. The available evidence suggests that intervention effect estimates may be exaggerated in trials with inadequate/unclear (versus adequate) sequence generation (ROR 0.93, 95% CI 0.86 to 0.99; 7 studies) and allocation concealment (ROR 0.90, 95% CI 0.84 to 0.97; 7...

  11. Methods for sample size determination in cluster randomized trials.

    Science.gov (United States)

    Rutterford, Clare; Copas, Andrew; Eldridge, Sandra

    2015-06-01

    The use of cluster randomized trials (CRTs) is increasing, along with the variety in their design and analysis. The simplest approach for their sample size calculation is to calculate the sample size assuming individual randomization and inflate this by a design effect to account for randomization by cluster. The assumptions of a simple design effect may not always be met; alternative or more complicated approaches are required. We summarise a wide range of sample size methods available for cluster randomized trials. For those familiar with sample size calculations for individually randomized trials but with less experience in the clustered case, this manuscript provides formulae for a wide range of scenarios with associated explanation and recommendations. For those with more experience, comprehensive summaries are provided that allow quick identification of methods for a given design, outcome and analysis method. We present first those methods applicable to the simplest two-arm, parallel group, completely randomized design followed by methods that incorporate deviations from this design such as: variability in cluster sizes; attrition; non-compliance; or the inclusion of baseline covariates or repeated measures. The paper concludes with methods for alternative designs. There is a large amount of methodology available for sample size calculations in CRTs. This paper gives the most comprehensive description of published methodology for sample size calculation and provides an important resource for those designing these trials. © The Author 2015. Published by Oxford University Press on behalf of the International Epidemiological Association.

  12. A systematic review found that deviations from intention-to-treat are common in randomized trials and systematic reviews.

    Science.gov (United States)

    Abraha, Iosief; Cozzolino, Francesco; Orso, Massimiliano; Marchesi, Mauro; Germani, Antonella; Lombardo, Guido; Eusebi, Paolo; De Florio, Rita; Luchetta, Maria Laura; Iorio, Alfonso; Montedori, Alessandro

    2017-04-01

    To describe the characteristics, and estimate the incidence, of trials included in systematic reviews deviating from the intention-to-treat (ITT) principle. A 5% random sample of reviews were selected (Medline 2006-2010). Trials from reviews were classified based on the ITT: (1) ITT trials (trials reporting standard ITT analyses); (2) modified ITT (mITT) trials (modified ITT; trials deviating from standard ITT); or (3) no ITT trials. Of 222 reviews, 81 (36%) included at least one mITT trial. Reviews with mITT trials were more likely to contain trials that used placebo, that investigated drugs, and that reported favorable results. The incidence of reviews with mITT trial ranged from 29% (17/58) to 48% (23/48). Of the 2,349 trials, 597 (25.4%) were classified as ITT trials, 323 (13.8%) as mITT trials, and 1,429 (60.8%) as no ITT trials. The mITT trials were more likely to have reported exclusions compared to studies classified as ITT trials and to have received funding. The reporting of the type of ITT may differ according to the clinical area and the type of intervention. Deviation from ITT in randomized controlled trials is a widespread phenomenon that significantly affects systematic reviews. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. Protocol for the Locomotor Experience Applied Post-stroke (LEAPS trial: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Wu Samuel S

    2007-11-01

    Full Text Available Abstract Background Locomotor training using body weight support and a treadmill as a therapeutic modality for rehabilitation of walking post-stroke is being rapidly adopted into clinical practice. There is an urgent need for a well-designed trial to determine the effectiveness of this intervention. The objective of the Locomotor Experience Applied Post-Stroke (LEAPS trial is to determine if there is a difference in the proportion of participants who recover walking ability at one year post-stroke when randomized to a specialized locomotor training program (LTP, conducted at 2- or 6-months post-stroke, or those randomized to a home based non-specific, low intensity exercise intervention (HEP provided 2 months post-stroke. We will determine if the timing of LTP delivery affects gait speed at 1 year and whether initial impairment severity interacts with the timing of LTP. The effect of number of treatment sessions will be determined by changes in gait speed taken pre-treatment and post-12, -24, and -36 sessions. Methods/Design We will recruit 400 adults with moderate or severe walking limitations within 30 days of stroke onset. At two months post stroke, participants are stratified by locomotor impairment severity as determined by overground walking speed and randomly assigned to one of three groups: (a LTP-Early; (b LTP-Late or (c Home Exercise Program -Early. The LTP program includes body weight support on a treadmill and overground training. The LTP and HEP interventions are delivered for 36 sessions over 12 weeks. Primary outcome measure include successful walking recovery defined as the achievement of a 0.4 m/s gait speed or greater by persons with initial severe gait impairment or the achievement of a 0.8 m/s gait speed or greater by persons with initial moderate gait impairment. LEAPS is powered to detect a 20% difference in the proportion of participants achieving successful locomotor recovery between the LTP groups and the HEP group, and

  14. Hypnotherapy in radiotherapy patients: A randomized trial

    NARCIS (Netherlands)

    Stalpers, Lukas J. A.; da Costa, Hanna C.; Merbis, Merijn A. E.; Fortuin, Andries A.; Muller, Martin J.; van Dam, Frits S. A. M.

    2005-01-01

    Purpose: To determine whether hypnotherapy reduces anxiety and improves the quality of life in cancer patients undergoing curative radiotherapy (RT). Methods and Materials: After providing written informed consent, 69 patients were randomized between standard curative RT alone (36 controls) and RT

  15. The quality and reporting of randomized trials in cardiothoracic physical therapy could be substantially improved.

    Science.gov (United States)

    Geha, Nádia N; Moseley, Anne M; Elkins, Mark R; Chiavegato, Luciana D; Shiwa, Silvia R; Costa, Leonardo O P

    2013-11-01

    While the number of reports of randomized controlled trials in physical therapy has increased substantially in the last decades, the quality and reporting of randomized trials have never been systematically investigated in the subdiscipline of cardiothoracic physical therapy. The primary aim was to determine the methodological quality and completeness of reporting of cardiothoracic physical therapy trials. Secondary aims were to investigate the range of clinical conditions investigated in these trials and the degree of association between trial characteristics and quality. All reports of randomized trials indexed on the Physiotherapy Evidence Database (PEDro) and coded as being relevant to cardiothoracic physical therapy were surveyed. PEDro scale individual items and total score were downloaded, and some characteristics included in the Consolidated Standards of Reporting Trials (CONSORT) statement were extracted for each trial report. The mean ± SD total PEDro score for the 2,970 included reports of cardiothoracic trials was 4.7 ± 1.4, with 27% being of moderate to high quality. The clinical conditions studied included chronic lung diseases (32% of the trials), cardiac diseases (20%), cardiovascular surgical conditions (5%), sleep disorders (5%), peripheral vascular disease (4%), acute lung disease (4%), critical illness (3%), and other surgical conditions (3%). The multivariate linear regression analysis revealed that endorsement of the CONSORT statement by the publishing journal, time since publication, evidence of trial registration, sources of funding, description of the sample size calculation, and identification of the primary outcome(s) had associations with the total PEDro score. There is great potential to improve the quality of the conduct and reporting of trials evaluating the effects of cardiothoracic physical therapy.

  16. Dry cupping for plantar fasciitis: a randomized controlled trial.

    Science.gov (United States)

    Ge, Weiqing; Leson, Chelsea; Vukovic, Corey

    2017-05-01

    [Purpose] The purpose of this study was to determine the effects of dry cupping on pain and function of patients with plantar fasciitis. [Subjects and Methods] Twenty-nine subjects (age 15 to 59 years old, 20 females and 9 males), randomly assigned into the two groups (dry cupping therapy and electrical stimulation therapy groups), participated in this study. The research design was a randomized controlled trial (RCT). Treatments were provided to the subjects twice a week for 4 weeks. Outcome measurements included the Visual Analogue Pain Scale (VAS) (at rest, first in the morning, and with activities), the Foot and Ankle Ability Measure (FAAM), the Lower Extremity Functional Scale (LEFS), as well as the pressure pain threshold. [Results]The data indicated that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function significantly in the population tested, as all the 95% Confidence Intervals (CIs) did not include 0 except for the pressure pain threshold. There was no significant difference between the dry cupping therapy and electrical stimulation groups in all the outcome measurements. [Conclusion] These results support that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function in the population tested.

  17. Dry cupping for plantar fasciitis: a randomized controlled trial

    Science.gov (United States)

    Ge, Weiqing; Leson, Chelsea; Vukovic, Corey

    2017-01-01

    [Purpose] The purpose of this study was to determine the effects of dry cupping on pain and function of patients with plantar fasciitis. [Subjects and Methods] Twenty-nine subjects (age 15 to 59 years old, 20 females and 9 males), randomly assigned into the two groups (dry cupping therapy and electrical stimulation therapy groups), participated in this study. The research design was a randomized controlled trial (RCT). Treatments were provided to the subjects twice a week for 4 weeks. Outcome measurements included the Visual Analogue Pain Scale (VAS) (at rest, first in the morning, and with activities), the Foot and Ankle Ability Measure (FAAM), the Lower Extremity Functional Scale (LEFS), as well as the pressure pain threshold. [Results]The data indicated that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function significantly in the population tested, as all the 95% Confidence Intervals (CIs) did not include 0 except for the pressure pain threshold. There was no significant difference between the dry cupping therapy and electrical stimulation groups in all the outcome measurements. [Conclusion] These results support that both dry cupping therapy and electrical stimulation therapy could reduce pain and increase function in the population tested. PMID:28603360

  18. Randomized Trial of 2 Versus 1 Dose of Measles Vaccine

    DEFF Research Database (Denmark)

    Brønd, Marie; Martins, Cesario L; Byberg, Stine

    2018-01-01

    Background: Two doses of measles vaccine (MV) might reduce the nonmeasles mortality rate more than 1 dose of MV does. The effect of 2 versus 1 dose on morbidity has not been examined. Within a randomized trial of the effect of 2 doses versus 1 dose of MV on mortality in Guinea-Bissau, we investig......Background: Two doses of measles vaccine (MV) might reduce the nonmeasles mortality rate more than 1 dose of MV does. The effect of 2 versus 1 dose on morbidity has not been examined. Within a randomized trial of the effect of 2 doses versus 1 dose of MV on mortality in Guinea-Bissau, we...... measles vaccination policy might reduce hospital admissions more than the current policy of providing the first MV at 9 months of age. Trial registration: ClinicalTrials.gov identifier NCT00168558....

  19. Mirtazapine to reduce methamphetamine use: a randomized controlled trial.

    Science.gov (United States)

    Colfax, Grant N; Santos, Glenn-Milo; Das, Moupali; Santos, Deirdre McDermott; Matheson, Tim; Gasper, James; Shoptaw, Steve; Vittinghoff, Eric

    2011-11-01

    No approved pharmacologic treatments for methamphetamine dependence exist. Methamphetamine use is associated with high morbidity and is a major cofactor in the human immunodeficiency virus epidemic among men who have sex with men (MSM). To determine whether mirtazapine would reduce methamphetamine use among MSM who are actively using methamphetamine. Double-blind, randomized, controlled, 12-week trial of mirtazapine vs placebo conducted from September 5, 2007, to March 4, 2010. San Francisco Department of Public Health. Participants were actively using, methamphetamine-dependent, sexually active MSM seen weekly for urine sample collection and substance use counseling. Random assignment to daily oral mirtazapine (30 mg) or placebo; both arms included 30-minute weekly substance use counseling. The primary study outcome was reduction in methamphetamine-positive urine test results. Secondary outcomes were study medication adherence (by self-report and medication event monitoring systems) and sexual risk behavior. Sixty MSM were randomized, 85% of follow-up visits were completed, and 56 participants (93%) completed the final visit. In the primary intent-to-treat analysis, participants assigned to the mirtazapine group had fewer methamphetamine-positive urine test results compared with participants assigned to the placebo group (relative risk, 0.57; 95% CI, 0.35-0.93, P = .02). Urine positivity decreased from 67% (20 of 30 participants) to 63% (17 of 27) in the placebo arm and from 73% (22 of 30) to 44% (12 of 27) in the mirtazapine arm. The number needed to treat to achieve a negative weekly urine test result was 3.1. Adherence was 48.5% by medication event monitoring systems and 74.7% by self-report; adherence measures were not significantly different between arms (medication event monitoring systems, P = .82; self-report, P = .92). Most sexual risk behaviors decreased significantly more among participants taking mirtazapine compared with those taking placebo

  20. Fool’s gold, lost treasures, and the randomized clinical trial

    Science.gov (United States)

    2013-01-01

    Background Randomized controlled trials with a survival endpoint are the gold standard for clinical research, but have failed to achieve cures for most advanced malignancies. The high costs of randomized clinical trials slow progress (thereby causing avoidable loss of life) and increase health care costs. Discussion A malignancy may be caused by several different mutations. Therapies effective vs one mutation may be discarded due to lack of statistical significance across the entire population. Conversely, expensive large randomized trials may have sufficient statistical power to demonstrate benefit despite the therapy only working in subgroups. Non-cost-effective therapy is then applied to all patients (including subgroups it cannot help). Randomized trials comparing therapies with different mechanisms of action are misleading since they may conclude the therapies are “equivalent” despite benefitting different subpopulations, or may erroneously conclude that one therapy is superior simply because it targets a larger subpopulation. Furthermore, minor variances in patient selection may determine study outcome, a therapy may be discarded as ineffective despite substantial benefit in one subpopulation if harmful in another, randomized trials may more effectively detect therapies with minor benefit in most patients vs marked benefit in subpopulations, and randomized trials in unselected patients may erroneously conclude that “shot-gun” combinations are superior to single agents when sequential administration of personalized single agents might work better and spare patients treatment with drugs that cannot help them. We must identify predictive biomarkers early by comparing responding to progressing patients in phase I-II trials. Enriching randomized trials for biomarker-positive patients can markedly reduce required patient numbers and costs despite expensive screening for biomarker-positive patients. Available data support approval of new drugs without

  1. Do we have to Include HCI Issues in Clinical Trials of Medical Devices?

    DEFF Research Database (Denmark)

    Nielsen, Lene; Christensen, Lars Rune; Sabers, Anne

    2017-01-01

    Digital devices play an important role in medical treatment and will in the future play a larger role in connection to cures of health-related issues. Traditionally medicine has been tested by clinical double blind, randomized trials to document the efficacy and safety profile. When it comes to t...

  2. The Danish randomized lung cancer CT screening trial

    DEFF Research Database (Denmark)

    Pedersen, Jesper H; Ashraf, Haseem; Dirksen, Asger

    2009-01-01

    INTRODUCTION: Lung cancer screening with low dose computed tomography (CT) has not yet been evaluated in randomized clinical trials, although several are underway. METHODS: In The Danish Lung Cancer Screening Trial, 4104 smokers and previous smokers from 2004 to 2006 were randomized to either...... lung cancer. Ten of these had stage I disease. Eleven of 17 lung cancers at baseline were treated surgically, eight of these by video assisted thoracic surgery resection. CONCLUSIONS: Screening may facilitate minimal invasive treatment and can be performed with a relatively low rate of false......-positive screen results compared with previous studies on lung cancer screening....

  3. RANDOMIZED CONTROLLED CLINICAL TRIALS IN ORTHOPEDICS: DIFFICULTIES AND LIMITATIONS

    Science.gov (United States)

    Malavolta, Eduardo Angeli; Demange, Marco Kawamura; Gobbi, Riccardo Gomes; Imamura, Marta; Fregni, Felipe

    2015-01-01

    Randomized controlled clinical trials (RCTs) are considered to be the gold standard for evidence-based medicine nowadays, and are important for directing medical practice through consistent scientific observations. Steps such as patient selection, randomization and blinding are fundamental for conducting a RCT, but some additional difficulties are presented in trials that involve surgical procedures, as is common in orthopedics. The aim of this article was to highlight and discuss some difficulties and possible limitations on RCTs within the field of surgery. PMID:27027037

  4. Fundamentals of randomized clinical trials in wound care

    DEFF Research Database (Denmark)

    Eskes, Anne M; Brölmann, Fleur E; Sumpio, Bauer E

    2012-01-01

    acknowledged as the study design of choice for comparing treatment effects, as they eliminate several sources of bias. We propose a framework for the design and conduct of future randomized clinical trials that will offer strong scientific evidence for the effectiveness of wound care interventions. While......The care for chronic and acute wounds is a substantial problem around the world. This has led to a plethora of products to accelerate healing. Unfortunately, the quality of studies evaluating the efficacy of such wound care products is frequently low. Randomized clinical trials are universally....... This article proposes strategies for improving the evidence base for wound care decision making....

  5. Traditional invasive vs. minimally invasive esophagectomy: a multi-center, randomized trial (TIME-trial

    Directory of Open Access Journals (Sweden)

    de Lange Elly SM

    2011-01-01

    Full Text Available Abstract Background There is a rise in incidence of esophageal carcinoma due to increasing incidence of adenocarcinoma. Probably the only curative option to date is the use of neoadjuvant therapy followed by surgical resection. Traditional open esophageal resection is associated with a high morbidity and mortality rate. Furthermore, this approach involves long intensive care unit stay, in-hospital stay and long recovery period. Minimally invasive esophagectomy could reduce the morbidity and accelerate the post-operative recovery. Methods/Design Comparison between traditional open and minimally invasive esophagectomy in a multi-center, randomized trial. Patients with a resectable intrathoracic esophageal carcinoma, including the gastro-esophageal junction tumors (Siewert I are eligible for inclusion. Prior thoracic surgery and cervical esophageal carcinoma are indications for exclusion. The surgical technique involves a right thoracotomy with lung blockade and laparotomy either with a cervical or thoracic anastomosis for the traditional group. The minimally invasive procedure involves a right thoracoscopy in prone position with a single lumen tube and laparoscopy either with a cervical or thoracic anastomosis. All patients in both groups will undergo identical pre-operative and post-operative protocol. Primary endpoint of this study are post-operative respiratory complications within the first two post-operative weeks confirmed by clinical, radiological and sputum culture data. Secondary endpoints are the operative data, the post-operative data and oncological data such as quality of the specimen and survival. Operative data include duration of the operation, blood loss and conversion to open procedure. Post-operative data include morbidity (major and minor, quality of life tests and hospital stay. Based on current literature and the experience of all participating centers, an incidence of pulmonary complications for 57% in the traditional arm

  6. Blinded trials taken to the test: an analysis of randomized clinical trials that report tests for the success of blinding

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Forfang, E; Haahr, M T

    2007-01-01

    Blinding can reduce bias in randomized clinical trials, but blinding procedures may be unsuccessful. Our aim was to assess how often randomized clinical trials test the success of blinding, the methods involved and how often blinding is reported as being successful.......Blinding can reduce bias in randomized clinical trials, but blinding procedures may be unsuccessful. Our aim was to assess how often randomized clinical trials test the success of blinding, the methods involved and how often blinding is reported as being successful....

  7. Chinese herbal medicine for cancer-related fatigue: a systematic review of randomized clinical trials.

    Science.gov (United States)

    Su, Chun-Xiang; Wang, Li-Qiong; Grant, Suzanne J; Liu, Jian-Ping

    2014-06-01

    To assess the effectiveness and safety of Chinese herbal medicine for the treatment of cancer-related fatigue. We systematically searched seven electronic databases and two trial registries for randomized clinical trials of Chinese herbal medicine for cancer-related fatigue. Two authors independently extracted data and assessed the methodological quality of the included trials using the Cochrane risk of bias tool. Data were synthesized using RevMan 5.2 software. A total of 10 trials involving 751 participants with cancer-related fatigue were identified and the methodological quality of the included trials was generally poor. Chinese herbal medicine used alone or in combination with chemotherapy or supportive care showed significant relief in cancer-related fatigue compared to placebo, chemotherapy or supportive care based on single trials. Chinese herbal medicine plus chemotherapy or supportive care was superior to chemotherapy or supportive care in improving quality of life. Data from one trial demonstrated Chinese herbal medicine exerted a greater beneficial effect on relieving anxiety but no difference in alleviating depression. Seven trials reported adverse events and no severe adverse effects were found in Chinese herbal medicine groups. The findings from limited number of trials suggest that Chinese herbal medicine seems to be effective and safe in the treatment of cancer-related fatigue. However, the current evidence is insufficient to draw a confirmative conclusion due to the poor methodological quality of included trials. Thus, conducting rigorously designed trials on potential Chinese herbal medicine is warranted. Copyright © 2014 Elsevier Ltd. All rights reserved.

  8. Use acupuncture to treat functional constipation: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Li Ying

    2012-07-01

    Full Text Available Abstract Background Whether acupuncture is effective for patients with functional constipation is still unclear. Therefore, we report the protocol of a randomized controlled trial of using acupuncture to treat functional constipation. Design A randomized, controlled, four-arm design, large-scale trial is currently undergoing in China. Seven hundred participants are randomly assigned to three acupuncture treatment groups and Mosapride Citrate control group in a 1:1:1:1 ratio. Participants in acupuncture groups receive 16 sessions of acupuncture treatment, and are followed up for a period of 9 weeks after randomization. The acupuncture groups are: (1 Back-Shu and Front-Mu acupoints of Large Intestine meridians (Shu-Mu points group; (2 He-Sea and Lower He-Sea acupoints of Large Intestine meridians (He points group; (3 Combining used Back-Shu, Front-Mu, He-Sea, and Lower He-Sea acupoints of Large Intestine meridians (Shu-Mu-He points group. The control group is Mosapride Citrate group. The primary outcome is frequency of defecation per week at the fourth week after randomization. The secondary outcomes include Bristol stool scale, the extent of difficulty during defecating, MOS 36-item Short Form health survey (SF-36, Self-Rating Anxiety Scale (SAS, and Self-rating Depression Scale (SDS. The first two of second outcomes are measured 1 week before randomization and 2, 4, and 8 weeks after randomization. Other second outcomes are measured 1 week before randomization and 2 and 4 weeks after randomization, but SF-36 is measured at randomization and 4 weeks after randomization. Discussion The result of this trial (which will be available in 2012 will confirm whether acupuncture is effective to treat functional constipation and whether traditional acupuncture theories play an important role in it. Trials registration Clinical Trials.gov NCT01411501

  9. Blocking nocturnal blue light for insomnia: A randomized controlled trial.

    Science.gov (United States)

    Shechter, Ari; Kim, Elijah Wookhyun; St-Onge, Marie-Pierre; Westwood, Andrew J

    2017-10-21

    The use of light-emitting electronic devices before bedtime may contribute to or exacerbate sleep problems. Exposure to blue-wavelength light in particular from these devices may affect sleep by suppressing melatonin and causing neurophysiologic arousal. We aimed to determine if wearing amber-tinted blue light-blocking lenses before bedtime improves sleep in individuals with insomnia. Fourteen individuals (n = 8 females; age ± SD 46.6 ± 11.5 y) with insomnia symptoms wore blue light-blocking amber lenses or clear placebo lenses in lightweight wraparound frames for 2 h immediately preceding bedtime for 7 consecutive nights in a randomized crossover trial (4-wk washout). Ambulatory sleep measures included the Pittsburgh Insomnia Rating Scale (PIRS) completed at the end of each intervention period, and daily post-sleep questionnaire and wrist-actigraphy. PIRS total scores, and Quality of Life, Distress, and Sleep Parameter subscales, were improved in amber vs. clear lenses condition (p-values sleep time (TST), overall quality, and soundness of sleep were significantly higher (p-values sleep in individuals with insomnia symptoms. These findings have health relevance given the broad use of light-emitting devices before bedtime and prevalence of insomnia. Amber lenses represent a safe, affordable, and easily implemented therapeutic intervention for insomnia symptoms. ClinicalTrials.gov Identifier: NCT02698800. Copyright © 2017. Published by Elsevier Ltd.

  10. Acupuncture for Menopausal Hot Flashes: A Randomized Trial.

    Science.gov (United States)

    Ee, Carolyn; Xue, Charlie; Chondros, Patty; Myers, Stephen P; French, Simon D; Teede, Helena; Pirotta, Marie

    2016-02-02

    Hot flashes (HFs) affect up to 75% of menopausal women and pose a considerable health and financial burden. Evidence of acupuncture efficacy as an HF treatment is conflicting. To assess the efficacy of Chinese medicine acupuncture against sham acupuncture for menopausal HFs. Stratified, blind (participants, outcome assessors, and investigators, but not treating acupuncturists), parallel, randomized, sham-controlled trial with equal allocation. (Australia New Zealand Clinical Trials Registry: ACTRN12611000393954). Community in Australia. Women older than 40 years in the late menopausal transition or postmenopause with at least 7 moderate HFs daily, meeting criteria for Chinese medicine diagnosis of kidney yin deficiency. 10 treatments over 8 weeks of either standardized Chinese medicine needle acupuncture designed to treat kidney yin deficiency or noninsertive sham acupuncture. The primary outcome was HF score at the end of treatment. Secondary outcomes included quality of life, anxiety, depression, and adverse events. Participants were assessed at 4 weeks, the end of treatment, and then 3 and 6 months after the end of treatment. Intention-to-treat analysis was conducted with linear mixed-effects models. 327 women were randomly assigned to acupuncture (n = 163) or sham acupuncture (n = 164). At the end of treatment, 16% of participants in the acupuncture group and 13% in the sham group were lost to follow-up. Mean HF scores at the end of treatment were 15.36 in the acupuncture group and 15.04 in the sham group (mean difference, 0.33 [95% CI, -1.87 to 2.52]; P = 0.77). No serious adverse events were reported. Participants were predominantly Caucasian and did not have breast cancer or surgical menopause. Chinese medicine acupuncture was not superior to noninsertive sham acupuncture for women with moderately severe menopausal HFs. National Health and Medical Research Council.

  11. Minocycline in Acute Cerebral Hemorrhage: An Early Phase Randomized Trial.

    Science.gov (United States)

    Fouda, Abdelrahman Y; Newsome, Andrea S; Spellicy, Samantha; Waller, Jennifer L; Zhi, Wenbo; Hess, David C; Ergul, Adviye; Edwards, David J; Fagan, Susan C; Switzer, Jeffrey A

    2017-10-01

    Minocycline is under investigation as a neurovascular protective agent for stroke. This study evaluated the pharmacokinetic, anti-inflammatory, and safety profile of minocycline after intracerebral hemorrhage. This study was a single-site, randomized controlled trial of minocycline conducted from 2013 to 2016. Adults ≥18 years with primary intracerebral hemorrhage who could have study drug administered within 24 hours of onset were included. Patients received 400 mg of intravenous minocycline, followed by 400 mg minocycline oral daily for 4 days. Serum concentrations of minocycline after the last oral dose and biomarkers were sampled to determine the peak concentration, half-life, and anti-inflammatory profile. A total of 16 consecutive eligible patients were enrolled, with 8 randomized to minocycline. Although the literature supports a time to peak concentration (Tmax) of 1 hour for oral minocycline, the Tmax was estimated to be at least 6 hours in this cohort. The elimination half-life (available on 7 patients) was 17.5 hours (SD±3.5). No differences were observed in inflammatory biomarkers, hematoma volume, or perihematomal edema. Concentrations remained at neuroprotective levels (>3 mg/L) throughout the dosing interval in 5 of 7 patients. In intracerebral hemorrhage, a 400 mg dose of minocycline was safe and achieved neuroprotective serum concentrations. However, oral administration led to delayed absorption in these critically ill patients and should not be used when rapid, high concentrations are desired. Given the safety and pharmacokinetic profile of minocycline in intracerebral hemorrhage and promising data in the treatment of ischemic stroke, intravenous minocycline is an excellent candidate for a prehospital treatment trial. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01805895. © 2017 American Heart Association, Inc.

  12. Minimally invasive surgery for spontaneous supratentorial intracerebral hemorrhage: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Zhou, Xinyu; Chen, Jianjun; Li, Qi; Ren, Gaoping; Yao, Guoen; Liu, Ming; Dong, Qiang; Guo, Jìng; Li, Leilei; Guo, Jing; Xie, Peng

    2012-11-01

    There has been a nonstandard surgical procedure and extensive international controversy in minimally invasive surgery (MIS) for the management of spontaneous supratentorial intracerebral hemorrhage. This meta-analysis assessed the effectiveness of MIS as compared with other treatment options, including conservative medical treatment and conventional craniotomy, in patients with supratentorial intracerebral hemorrhage. PubMed, Embase, Cochrane Controlled Trials Register (CCTR), Web of Science, European Association for Grey Literature Exploitation (EAGLE), National Technical Information Service (NTIS), Current Controlled Trials, Clinical Trials, International Clinical Trials Registry, Internet Stroke Center, Chinese Biomedical Literature Database (CBM), Chinese National Knowledge Infrastructure (CNKI) (last searched December 2011) were searched. Randomized controlled trials on MIS in patients with computed tomography-confirmed supratentorial intracerebral hemorrhage were included. We excluded low-quality randomized controlled trials. The death or dependence at the end of follow-up was defined as the primary outcome, and the death at the end of follow-up was defined as the secondary outcome. The 313 randomized controlled trials met the included criteria. We only analyzed 12 high-quality randomized controlled trials involving 1955 patients. The quality of the included trials was consistently high. OR of the primary outcome and secondary outcome of MIS both showed significant reductions (OR, 0.54, P<0.00001; OR, 0.53, P<0.00001). Patients with supratentorial intracerebral hemorrhage may benefit more from MIS than other treatment options. The most likely candidates to benefit from MIS are both sexes, age of 30 to 80 years with superficial hematoma, Glasgow Coma Scale score of ≥9, hematoma volume between 25 and 40 mL, and within 72 hours after onset of symptoms. Our study could help select appropriate patients for MIS and guide clinicians to optimize treatment

  13. Dry cupping for plantar fasciitis: a randomized controlled trial

    OpenAIRE

    Ge, Weiqing; Leson, Chelsea; Vukovic, Corey

    2017-01-01

    [Purpose] The purpose of this study was to determine the effects of dry cupping on pain and function of patients with plantar fasciitis. [Subjects and Methods] Twenty-nine subjects (age 15 to 59?years old, 20 females and 9 males), randomly assigned into the two groups (dry cupping therapy and electrical stimulation therapy groups), participated in this study. The research design was a randomized controlled trial (RCT). Treatments were provided to the subjects twice a week for 4 weeks. Outcome...

  14. A randomized trial assessing the impact of written information on outpatients' knowledge about and attitude toward randomized clinical trials. The Info Trial Group

    DEFF Research Database (Denmark)

    Kruse, A Y; Kjaergard, L L; Krogsgaard, K

    2000-01-01

    To improve the patient education process in clinical research, three information materials describing general aspects of design and conduct of randomized clinical trials were developed. The materials varied in length, reading ability level, and reader appeal. Their influence on knowledge about...... the total attitude score (4.8 points) and the randomized clinical trials attitude subscale score (1.8 points). In conclusion, written information significantly improved outpatients' knowledge about and attitude toward randomized clinical trials. Detailed rather than brief information was more effective...

  15. The conduct and principles of randomized clinical trials.

    Science.gov (United States)

    Klimt, C R

    1981-05-01

    Some of the guiding principles as well as the pitfall of long-term randomized clinical trials are presented. Examples have been chosen from trials in the cardiovascular field. A typical long-term clinical trial is divided into five phases: planning, preparation, recruitment, clinical follow-up and termination, and finally analysis. Administrative, legal, and ethical aspects of a trial are discussed, as well as the cost of clinical trials. Organization patterns are described and some prevalent ones are criticized. Further, practical matters such as recruitment techniques, obtaining informed consent from the patients, determining drug dosage and formulation as well as the problem of interaction with nonstudy drugs are referred to. Adherence testing remains a problem, because of our inability to test for placebo adherence.

  16. Subjective and objective outcomes in randomized clinical trials

    DEFF Research Database (Denmark)

    Moustgaard, Helene; Bello, Segun; Miller, Franklin G

    2014-01-01

    OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... "subjective outcome" and "objective outcome" are defined in methodological publications and clinical trial reports. To put this examination into perspective, we also provide an overview of how outcomes are classified more broadly. STUDY DESIGN AND SETTING: A systematic review of methodological publications...... provided for subjective outcome: (1) dependent on assessor judgment, (2) patient-reported outcome, or (3) private phenomena (ie, phenomena only assessable by the patient). Of the 200 clinical trial reports, 12 used the term "subjective" and/or "objective" about outcomes, but no clinical trial reports...

  17. Online psychoeducational support for infertile women: a randomized controlled trial

    Science.gov (United States)

    Cousineau, Tara M.; Green, Traci C.; Corsini, Evelyn; Seibring, A; Showstack, Marianne T.; Applegarth, Linda; Davidson, Marie; Perloe, Mark

    2008-01-01

    BACKGROUND The study goal was to develop and test the effectiveness of a brief online education and support program for female infertility patients. METHODS A randomized-controlled trial was conducted. Using a Solomon-four group design, 190 female patients were recruited from three US fertility centers and were randomized into two experimental and two no-treatment control groups. The psychological outcomes assessed included infertility distress, infertility self-efficacy, decisional conflict, marital cohesion and coping style. Program dosage and satisfaction were also assessed at four weeks follow-up. RESULTS Women exposed to the online program significantly improved in the area of social concerns (P = 0.038) related to infertility distress, and felt more informed about a medical decision with which they were contending (P = 0.037). Trends were observed for decreased global stress (P = 0.10), sexual concerns (P = 0.059), distress related to child-free living (P = 0.063), increased infertility self-efficacy (P = 0.067) and decision making clarity (P = 0.079). A dosage response was observed in the experimental groups for women who spent >60 min online for decreased global stress (P = 0.028) and increased self efficacy (P = 0.024). CONCLUSIONS This evidence-based eHealth program for women experiencing infertility suggests that a web-based patient education intervention can have beneficial effects in several psychological domains and may be a cost effective resource for fertility practices. PMID:18089552

  18. Rehabilitation programme after stem cell transplantation: randomized controlled trial.

    Science.gov (United States)

    Bird, Lydia; Arthur, Antony; Niblock, Tara; Stone, Rebecca; Watson, Lynn; Cox, Karen

    2010-03-01

    The aim of this study was to compare the effect of two methods of rehabilitation after stem cell transplantation on health and quality of life. Stem cell transplantation is routinely used in the treatment of haematological malignancy. However, it is an intensive treatment often associated with deterioration in wellbeing and the need for prolonged recovery. During a 14-month data collection period (August 2005 to October 2006), patients who had had a stem cell transplant (n = 58) were randomly allocated to either a healthcare professional-led rehabilitation programme or a self-managed rehabilitation programme. The primary outcome measure, physical functioning as measured by the 36-item Short Form Health Survey, was recorded at baseline and 6 months after randomization. Secondary health and quality of life measures included the seven other dimensions of the 36-item Short Form Health Survey, General Health Questionnaire, Graham and Longman Quality of Life Scale and a Shuttle Walk Test. There was no difference in change in Short Form 36 physical functioning scores between the two groups at follow-up (mean difference 0.19 points, 95% confidence interval 10.77-11.16). No evidence of a difference between the two modes of rehabilitation was observed for any of the trial outcomes. One approach for providing a flexible service may be for staff and individual patients to work together, selecting from a series of specified options a programme with the appropriate content and duration to meet that individual's needs.

  19. Design Issues in Randomized Clinical Trials of Maintenance Therapies.

    Science.gov (United States)

    Freidlin, Boris; Little, Richard F; Korn, Edward L

    2015-11-01

    A potential therapeutic strategy for patients who respond (or have stable disease) on a fixed-duration induction therapy is to receive maintenance therapy, typically given for a prolonged period of time. To enable patients and clinicians to make informed treatment decisions, the designs of phase III randomized clinical trials (RCTs) assessing maintenance strategies need to be such that their results will provide clear assessment of the relevant risks and benefits of these strategies. We review the key aspects of maintenance RCT designs. Important design considerations include choice of first-line and second-line therapies, minimizing between-arm differences in follow-up schedules, and choice of the primary endpoint. In order to change clinical practice, RCTs should be designed to accurately isolate and quantify the clinical benefit of maintenance as compared with the standard approach of fixed-duration induction followed by the second-line treatment at progression. To accomplish this, RCTs need to utilize an overall survival (or quality of life) endpoint or, in settings where this is not feasible, endpoints that incorporate the effects of the subsequent line of therapy (eg, time from randomization to second progression or death). Toxicity and symptom information over both the study treatment (maintenance) and the second-line treatment should also be collected and reported. Published by Oxford University Press 2015. This work is written by (a) US Government employee(s) and is in the public domain in the US.

  20. Randomized Clinical Trials on Deep Carious Lesions

    DEFF Research Database (Denmark)

    Bjørndal, Lars; Fransson, Helena; Bruun, Gitte

    2017-01-01

    nonselective carious removal to hard dentin with or without pulp exposure. The aim of this article was to report the 5-y outcome on these previously treated patients having radiographically well-defined carious lesions extending into the pulpal quarter of the dentin but with a well-defined radiodense zone...... between the carious lesion and the pulp. In this long-term study, 239 of 314 (76.2%) patients were analyzed. The stepwise removal group had a significantly higher proportion of success (60.2%) at 5-y follow-up compared with the nonselective carious removal to hard dentin group (46.3%) (P = 0.031) when......) in deep carious lesions in adults. In conclusion, the stepwise carious removal group had a significantly higher proportion of pulps with sustained vitality without apical radiolucency versus nonselective carious removal of deep carious lesions in adult teeth at 5-y follow-up (ClinicalTrials.gov NCT...

  1. Post-trial follow-up methodology in large randomized controlled trials: a systematic review protocol.

    Science.gov (United States)

    Llewellyn-Bennett, Rebecca; Bowman, Louise; Bulbulia, Richard

    2016-12-15

    Clinical trials typically have a relatively short follow-up period, and may both underestimate potential benefits of treatments investigated, and fail to detect hazards, which can take much longer to emerge. Prolonged follow-up of trial participants after the end of the scheduled trial period can provide important information on both efficacy and safety outcomes. This protocol describes a systematic review to qualitatively compare methods of post-trial follow-up used in large randomized controlled trials. A systematic search of electronic databases and clinical trial registries will use a predefined search strategy. All large (more than 1000 adult participants) randomized controlled trials will be evaluated. Two reviewers will screen and extract data according to this protocol with the aim of 95% concordance of papers checked and discrepancies will be resolved by a third reviewer. Trial methods, participant retention rates and prevalence of missing data will be recorded and compared. The potential for bias will be evaluated using the Cochrane Risk of Bias tool (applied to the methods used during the in-trial period) with the aim of investigating whether the quality of the post-trial follow-up methodology might be predicted by the quality of the methods used for the original trial. Post-trial follow-up can provide valuable information about the long-term benefits and hazards of medical interventions. However, it can be logistically challenging and costly. The aim of this systematic review is to describe how trial participants have been followed-up post-trial in order to inform future post-trial follow-up designs. Not applicable for PROSPERO registration.

  2. Impact of a cancer clinical trials web site on discussions about trial participation: a cluster randomized trial.

    Science.gov (United States)

    Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N

    2012-07-01

    Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.

  3. Naturopathic care for anxiety: a randomized controlled trial ISRCTN78958974.

    Directory of Open Access Journals (Sweden)

    Kieran Cooley

    Full Text Available BACKGROUND: Anxiety is a serious personal health condition and represents a substantial burden to overall quality of life. Additionally anxiety disorders represent a significant cost to the health care system as well as employers through benefits coverage and days missed due to incapacity. This study sought to explore the effectiveness of naturopathic care on anxiety symptoms using a randomized trial. METHODS: Employees with moderate to severe anxiety of longer than 6 weeks duration were randomized based on age and gender to receive naturopathic care (NC (n = 41 or standardized psychotherapy intervention (PT (n = 40 over a period of 12 weeks. Blinding of investigators and participants during randomization and allocation was maintained. Participants in the NC group received dietary counseling, deep breathing relaxation techniques, a standard multi-vitamin, and the herbal medicine, ashwagandha (Withania somnifera (300 mg b.i.d. standardized to 1.5% with anolides, prepared from root. The PT intervention received psychotherapy, and matched deep breathing relaxation techniques, and placebo. The primary outcome measure was the Beck Anxiety Inventory (BAI and secondary outcome measures included the Short Form 36 (SF-36, Fatigue Symptom Inventory (FSI, and Measure Yourself Medical Outcomes Profile (MY-MOP to measure anxiety, mental health, and quality of life respectively. Participants were blinded to the placebo-controlled intervention. RESULTS: Seventy-five participants (93% were followed for 8 or more weeks on the trial. Final BAI scores decreased by 56.5% (p<0.0001 in the NC group and 30.5% (p<0.0001 in the PT group. BAI group scores were significantly decreased in the NC group compared to PT group (p = 0.003. Significant differences between groups were also observed in mental health, concentration, fatigue, social functioning, vitality, and overall quality of life with the NC group exhibiting greater clinical benefit. No serious adverse reactions

  4. Randomized, Controlled Trial of CBT Training for PTSD Providers

    Science.gov (United States)

    2016-10-01

    Traumatic Stress Disorder (PTSD) and related psychological health difficulties in Veterans and military personnel who suffer from these problems. To meet...therapy (CBT) Post-Traumatic Stress Disorder (PTSD) Randomized controlled trial (RCT) Standardized Patient (SP) ACCOMPLISHMENTS This section...were presented at the American Psychological Association (APA) 2016 Convention in August 2016. iii. A Symposium will be presented at the International

  5. A Randomized Controlled Trial Study on the Effect of Adding ...

    African Journals Online (AJOL)

    A Randomized Controlled Trial Study on the Effect of Adding Dexmedetomidine to Bupivacaine in Supraclavicular Block Using Ultrasound Guidance. ... BACKGROUND: The benefits of regional anesthetic techniques are well established. Use of additives to local anesthetics can prolong these benefits. The aim of this study ...

  6. European Randomized Lung Cancer Screening Trials : Post NLST

    NARCIS (Netherlands)

    Field, John K.; van Klaveren, Rob; Pedersen, Jesper H.; Pastorino, Ugo; Paci, Eugino; Becker, Nikolauss; Infante, Maurizo; Oudkerk, Matthijs; de Koning, Harry J.

    2013-01-01

    Overview of the European randomized lung cancer CT screening trials (EUCT) is presented with regard to the implementation of CT screening in Europe; post NLST. All seven principal investigators completed a questionnaire on the epidemiological, radiological, and nodule management aspects of their

  7. Asthma Self-Management Model: Randomized Controlled Trial

    Science.gov (United States)

    Olivera, Carolina M. X.; Vianna, Elcio Oliveira; Bonizio, Roni C.; de Menezes, Marcelo B.; Ferraz, Erica; Cetlin, Andrea A.; Valdevite, Laura M.; Almeida, Gustavo A.; Araujo, Ana S.; Simoneti, Christian S.; de Freitas, Amanda; Lizzi, Elisangela A.; Borges, Marcos C.; de Freitas, Osvaldo

    2016-01-01

    Information for patients provided by the pharmacist is reflected in adhesion to treatment, clinical results and patient quality of life. The objective of this study was to assess an asthma self-management model for rational medicine use. This was a randomized controlled trial with 60 asthmatic patients assigned to attend five modules presented by…

  8. A double-blind randomized control trial of diazepam

    OpenAIRE

    1983-01-01

    A double-blind randomized controlled trial of diazepam against placebo in the management of minor conditions seen in general practice demonstrated that administration of either diazepam or placebo was associated with a substantial reduction in symptomatology three weeks later. There was no demonstrable difference between diazepam and placebo.

  9. Robustness and Optimal Design Issues for Cluster Randomized Trials

    NARCIS (Netherlands)

    Korendijk, E.|info:eu-repo/dai/nl/072035463

    2012-01-01

    Cluster randomized trials (CRT), in which whole clusters instead of individuals are assigned to conditions, are not uncommon in the social, behavioral, educational, medical and organizational sciences. Though the assignment of individuals to treatment conditions is more efficient, this may not

  10. A Randomized Trial Comparing Lichtenstein Repair and No Mesh ...

    African Journals Online (AJOL)

    Background: The objective of this study is to compare the outcomes of Lichtenstein repair and no mesh Desarda repair for inguinal hernia. Methods: This is a prospective randomized trial of 1382 patients having 1461 hernias operated from January 2002 to December 2011.704 patients were operated using ...

  11. Using Randomized Controlled Trials to Evaluate Interventions for Releasing Prisoners

    Science.gov (United States)

    Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia

    2016-01-01

    Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…

  12. Infant orthopedics and facial appearance: a randomized clinical trial (Dutchcleft).

    NARCIS (Netherlands)

    Prahl, C.; Prahl-Andersen, B.; Hof, M.A. van 't; Kuijpers-Jagtman, A.M.

    2006-01-01

    OBJECTIVE: To study the effect of infant orthopedics on facial appearance. DESIGN: Prospective two-arm randomized controlled trial in parallel with three participating academic cleft palate centers. Treatment allocation was concealed and performed by means of a computerized balanced allocation

  13. Assertive community treatment in the Netherlands : a randomized controlled trial

    NARCIS (Netherlands)

    Sytema, S.; Wunderink, L.; Bloemers, W.; Roorda, L.; Wiersma, D.

    Objective: Assertive community treatment is rapidly implemented by many European mental health services, but recently the evidence base has been questioned. Positive results of randomized trials in the USA were not replicated in the UK. The question is whether the UK findings are representative for

  14. A randomized controlled trial comparing haemodynamic stability in ...

    African Journals Online (AJOL)

    A randomized controlled trial comparing haemodynamic stability in elderly patients undergoing spinal anaesthesia at L5, S1 versus spinal anaesthesia at L3, 4 at a ... Conventionally, spinal anaesthesia is performed at the level of L3,4 interspace; with a reported incidence of hypotension in the elderly ranging between 65% ...

  15. The cohort multiple randomized controlled trial design: a valid and efficient alternative to pragmatic trials?

    Science.gov (United States)

    van der Velden, Joanne M; Verkooijen, Helena M; Young-Afat, Danny A; Burbach, Johannes Pm; van Vulpen, Marco; Relton, Clare; van Gils, Carla H; May, Anne M; Groenwold, Rolf Hh

    2017-02-01

    Randomized controlled trials (RCTs)-the gold standard for evaluating the effects of medical interventions-are notoriously challenging in terms of logistics, planning and costs. The cohort multiple randomized controlled trial approach is designed to facilitate randomized trials for pragmatic evaluation of (new) interventions and is a promising variation from conventional pragmatic RCTs. In this paper, we evaluate methodological challenges of conducting an RCT within a cohort. We argue that equally valid results can be obtained from trials conducted within cohorts as from pragmatic RCTs. However, whether this design is more efficient compared with conducting a pragmatic RCT depends on the amount and nature of non-compliance in the intervention arm. © The Author 2016; all rights reserved. Published by Oxford University Press on behalf of the International Epidemiological Association.

  16. OPPORTUNITY: a randomized clinical trial of growth hormone on outcome in hemodialysis patients

    DEFF Research Database (Denmark)

    Kopple, J.D.; Cheung, A.K.; Christiansen, J.S.

    2008-01-01

    , uncontrolled hypertension, chronic use of high-dose glucocorticoids, or immunosuppressive agents and pregnancy. CONCLUSIONS: The OPPORTUNITY Trial is the first large-scale randomized clinical trial in adult MHD patients evaluating the response to GH of such clinical endpoints as mortality, morbidity, markers...... human GH injections, compared with placebo, improve survival in hypoalbuminemic MHD patients. Secondary hypotheses are that GH improves morbidity and health, including number of hospitalized days, time to cardiovascular events, LBM, serum protein and inflammatory marker levels, exercise capacity...

  17. Hypnotherapy in radiotherapy patients: a randomized trial.

    Science.gov (United States)

    Stalpers, Lukas J A; da Costa, Hanna C; Merbis, Merijn A E; Fortuin, Andries A; Muller, Martin J; van Dam, Frits S A M

    2005-02-01

    To determine whether hypnotherapy reduces anxiety and improves the quality of life in cancer patients undergoing curative radiotherapy (RT). After providing written informed consent, 69 patients were randomized between standard curative RT alone (36 controls) and RT plus hypnotherapy (33 patients). Patients in the hypnotherapy group received hypnotherapy at the intake, before RT simulation, before the first RT session, and halfway between the RT course. Anxiety was evaluated by the State-Trait Anxiety Inventory DY-1 form at six points. Quality of life was measured by the Rand Medical Outcomes Study 36-item Health Survey (SF-36) at five points. Additionally, patients answered a questionnaire to evaluate their experience and the possible benefits of this research project. No statistically significant difference was found in anxiety or quality of life between the hypnotherapy and control groups. However, significantly more patients in the hypnotherapy group indicated an improvement in mental (p Hypnotherapy did not reduce anxiety or improve the quality of life in cancer patients undergoing curative RT. The absence of statistically significant differences between the two groups contrasts with the hypnotherapy patients' own sense of mental and overall well-being, which was significantly greater after hypnotherapy. It cannot be excluded that the extra attention by the hypnotherapist was responsible for this beneficial effect in the hypnotherapy group. An attention-only control group would be necessary to control for this effect.

  18. Randomized clinical trials in orthodontics are rarely registered a priori and often published late or not at all.

    Science.gov (United States)

    Papageorgiou, Spyridon N; Antonoglou, Georgios N; Sándor, George K; Eliades, Theodore

    2017-01-01

    A priori registration of randomized clinical trials is crucial to the transparency and credibility of their findings. Aim of this study was to assess the frequency with which registered and completed randomized trials in orthodontics are published. We searched ClinicalTrials.gov and ISRCTN for registered randomized clinical trials in orthodontics that had been completed up to January 2017 and judged the publication status and date of registered trials using a systematic protocol. Statistical analysis included descriptive statistics, chi-square or Fisher exact tests, and Kaplan-Meier survival estimates. From the 266 orthodontic trials registered up to January 2017, 80 trials had been completed and included in the present study. Among these 80 included trials, the majority (76%) were registered retrospectively, while only 33 (41%) were published at the time. The median time from completion to publication was 20.1 months (interquartile range: 9.1 to 31.6 months), while survival analysis indicated that less than 10% of the trials were published after 5 years from their completion. Finally, 22 (28%) of completed trials remain unpublished even after 5 years from their completion. Publication rates of registered randomized trials in orthodontics remained low, even 5 years after their completion date.

  19. Autologous blood injection for treatment of lateral epicondylosis: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Chou, Lin-Chuan; Liou, Tsan-Hon; Kuan, Yi-Chun; Huang, Yao-Hsien; Chen, Hung-Chou

    2016-03-01

    To appraise existing evidence of autologous blood injection in treating lateral epicondylosis. Meta-analysis of randomized controlled trials. A comprehensive search of the PubMed, Cochrane, SCOPUS, and CINAHL databases was performed to identify randomized controlled trials that reported the efficacy of autologous blood injection in treating lateral epicondylosis. The selected studies were subjected to a meta-analysis and risk of bias assessment. Patients with lateral epicondylosis. Pain-related measurement in each selected randomized controlled trial was pooled into meta-analysis. Nine randomized controlled trials were included in the analysis. The results of the meta-analysis including the pain scores indicated that autologous blood injection is more effective compared with corticosteroid injection (standard mean difference: -0.75; 95% confidence interval: -1.14 to -0.37) but not more effective compared with platelet-rich plasma injection (standard mean difference: 0.09; 95% confidence interval: -0.66 to 0.84). The risk of bias assessment indicated that all the included trials exhibited a moderate to high risk of bias. Autologous blood injection is more effective than corticosteroid injection but not more effective than platelet-rich plasma injection in treating lateral epicondylosis. However, this evidence is limited by the potential risk of bias. Copyright © 2015 Elsevier Ltd. All rights reserved.

  20. Herbal Medicine for Xerostomia in Cancer Patients: A Systematic Review of Randomized Controlled Trials.

    Science.gov (United States)

    Park, Bongki; Noh, Hyeonseok; Choi, Dong-Jun

    2017-09-01

    Xerostomia (dry mouth) causes many clinical problems, including oral infections, speech difficulties, and impaired chewing and swallowing of food. Many cancer patients have complained of xerostomia induced by cancer therapy. The aim of this systematic review is to assess the efficacy of herbal medicine for the treatment of xerostomia in cancer patients. Randomized controlled trials investigating the use of herbal medicines to treat xerostomia in cancer patients were included. We searched the following 12 databases without restrictions on time or language. The risk of bias was assessed using the Cochrane Risk of Bias Tool. Twenty-five randomized controlled trials involving 1586 patients met the inclusion criteria. A total of 24 formulas were examined in the included trials. Most of the included trials were insufficiently reported in the methodology section. Five formulas were shown to significantly improve the salivary flow rate compared to comparators. Regarding the grade of xerostomia, all formulas with the exception of a Dark Plum gargle solution with normal saline were significantly effective in reducing the severity of dry mouth. Adverse events were reported in 4 trials, and adverse effects of herbal medicine were reported in 3 trials. We found herbal medicines had potential benefits for improving salivary function and reducing the severity of dry mouth in cancer patients. However, methodological limitations and a relatively small sample size reduced the strength of the evidence. More high-quality trials reporting sufficient methodological data are warranted to enforce the strength of evidence regarding the effectiveness of herbal medicines.

  1. Components of effective randomized controlled trials of hydrotherapy programs for fibromyalgia syndrome: A systematic review

    Science.gov (United States)

    Perraton, Luke; Machotka, Zuzana; Kumar, Saravana

    2009-01-01

    Aim Previous systematic reviews have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome (FMS). The aim of this systematic review was to summarize the components of hydrotherapy programs used in randomized controlled trials. Method A systematic review of randomized controlled trials was conducted. Only trials that have reported significant FMS-related outcomes were included. Data relating to the components of hydrotherapy programs (exercise type, duration, frequency and intensity, environmental factors, and service delivery) were analyzed. Results Eleven randomized controlled trials were included in this review. Overall, the quality of trials was good. Aerobic exercise featured in all 11 trials and the majority of hydrotherapy programs included either a strengthening or flexibility component. Great variability was noted in both the environmental components of hydrotherapy programs and service delivery. Conclusions Aerobic exercise, warm up and cool-down periods and relaxation exercises are common features of hydrotherapy programs that report significant FMS-related outcomes. Treatment duration of 60 minutes, frequency of three sessions per week and an intensity equivalent to 60%–80% maximum heart rate were the most commonly reported exercise components. Exercise appears to be the most important component of an effective hydrotherapy program for FMS, particularly when considering mental health-related outcomes. PMID:21197303

  2. Components of effective randomized controlled trials of hydrotherapy programs for fibromyalgia syndrome: A systematic review

    Directory of Open Access Journals (Sweden)

    Luke Perraton

    2009-11-01

    Full Text Available Luke Perraton, Zuzana Machotka, Saravana KumarInternational Centre for Allied Health Evidence, University of South Australia, Adelaide, South Australia, AustraliaAim: Previous systematic reviews have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome (FMS. The aim of this systematic review was to summarize the components of hydrotherapy programs used in randomized controlled trials.Method: A systematic review of randomized controlled trials was conducted. Only trials that have reported significant FMS-related outcomes were included. Data relating to the components of hydrotherapy programs (exercise type, duration, frequency and intensity, environmental factors, and service delivery were analyzed.Results: Eleven randomized controlled trials were included in this review. Overall, the quality of trials was good. Aerobic exercise featured in all 11 trials and the majority of hydrotherapy programs included either a strengthening or flexibility component. Great variability was noted in both the environmental components of hydrotherapy programs and service delivery.Conclusions: Aerobic exercise, warm up and cool-down periods and relaxation exercises are common features of hydrotherapy programs that report significant FMS-related outcomes. Treatment duration of 60 minutes, frequency of three sessions per week and an intensity equivalent to 60%–80% maximum heart rate were the most commonly reported exercise components. Exercise appears to be the most important component of an effective hydrotherapy program for FMS, particularly when considering mental health-related outcomes.Keywords: hydrotherapy, fibromyalgia syndrome, exercise, effective, components

  3. Components of effective randomized controlled trials of hydrotherapy programs for fibromyalgia syndrome: A systematic review.

    Science.gov (United States)

    Perraton, Luke; Machotka, Zuzana; Kumar, Saravana

    2009-11-30

    Previous systematic reviews have found hydrotherapy to be an effective management strategy for fibromyalgia syndrome (FMS). The aim of this systematic review was to summarize the components of hydrotherapy programs used in randomized controlled trials. A systematic review of randomized controlled trials was conducted. Only trials that have reported significant FMS-related outcomes were included. Data relating to the components of hydrotherapy programs (exercise type, duration, frequency and intensity, environmental factors, and service delivery) were analyzed. Eleven randomized controlled trials were included in this review. Overall, the quality of trials was good. Aerobic exercise featured in all 11 trials and the majority of hydrotherapy programs included either a strengthening or flexibility component. Great variability was noted in both the environmental components of hydrotherapy programs and service delivery. Aerobic exercise, warm up and cool-down periods and relaxation exercises are common features of hydrotherapy programs that report significant FMS-related outcomes. Treatment duration of 60 minutes, frequency of three sessions per week and an intensity equivalent to 60%-80% maximum heart rate were the most commonly reported exercise components. Exercise appears to be the most important component of an effective hydrotherapy program for FMS, particularly when considering mental health-related outcomes.

  4. Grey literature in meta-analyses of randomized trials of health care interventions.

    Science.gov (United States)

    Hopewell, S; McDonald, S; Clarke, M; Egger, M

    2007-04-18

    The inclusion of grey literature (i.e. literature that has not been formally published) in systematic reviews may help to overcome some of the problems of publication bias, which can arise due to the selective availability of data. To review systematically research studies, which have investigated the impact of grey literature in meta-analyses of randomized trials of health care interventions. We searched the Cochrane Methodology Register (The Cochrane Library Issue 3, 2005), MEDLINE (1966 to 20 May 2005), the Science Citation Index (June 2005) and contacted researchers who may have carried out relevant studies. A study was considered eligible for this review if it compared the effect of the inclusion and exclusion of grey literature on the results of a cohort of meta-analyses of randomized trials. Data were extracted from each report independently by two reviewers. The main outcome measure was an estimate of the impact of trials from the grey literature on the pooled effect estimates of the meta-analyses. Information was also collected on the area of health care, the number of meta-analyses, the number of trials, the number of trial participants, the year of publication of the trials, the language and country of publication of the trials, the number and type of grey and published literature, and methodological quality. Five studies met the inclusion criteria. All five studies showed that published trials showed an overall greater treatment effect than grey trials. This difference was statistically significant in one of the five studies. Data could be combined for three of the five studies. This showed that, on average, published trials showed a 9% greater treatment effect than grey trials (ratio of odds ratios for grey versus published trials 1.09; 95% CI 1.03-1.16). Overall there were more published trials included in the meta-analyses than grey trials (median 224 (IQR 108-365) versus 45(IQR 40-102)). Published trials had more participants on average. The most

  5. Effect of timing of tracheotomy on clinical outcomes: an update meta-analysis including 11 trials.

    Science.gov (United States)

    Shan, Liang; Zhang, Rui; Li, Lian-di

    2013-09-01

    To estimate the relative effect of early vs. late tracheotomy on clinical end-points in unselected intensive care unit (ICU) patients undergoing mechanical ventilation. We searched electronic databases (up to February 27, 2013) for both randomized control trials and observational studies satisfying the predefined inclusion criteria. We retrieved 11 reports of studies including a total of 13 705 patients. Early tracheotomy was associated with significant reductions in mortality [33.3% vs. 36.3%; relative risk (RR); 0.92; 95% confidence interval (CI): 0.88, 0.97; I(2): 29%], length of ICU stay (mean difference: -6.55 days; 95% CI: -8.19, -4.90; I(2): 98%) and duration of mechanical ventilation (mean difference: -6.53 days; 95% CI: -11.43, -1.63; I(2): 100%). However, as compared with late tracheotomy, early tracheotomy did not reduce the incidence of hospital pneumonia (21.9% vs. 21.0%, RR: 0.85; 95% CI: 0.68, 1.06; I(2): 67%). Early tracheotomy can reduce length of ICU stay, duration of mechanical ventilation and mortality but has no influence on hospital pneumonia when compared with late tracheotomy. Once the decision has been made about tracheotomy, clinical physicians should not hesitate to perform the procedure.

  6. Publication of sports medicine-related randomized controlled trials registered in ClinicalTrials.gov.

    Science.gov (United States)

    Chahal, Jaskarndip; Tomescu, S Sebastian; Ravi, Bheeshma; Bach, Bernard R; Ogilvie-Harris, Darrell; Mohamed, Nizar N; Gandhi, Rajiv

    2012-09-01

    There is increasing evidence that a significant proportion of randomized trials in medicine, and recently in orthopaedics, do not go on to publication. The objectives of this study were (1) to determine publication rates of randomized controlled trials in sports medicine that have been registered with ClinicalTrials.gov (CTG) and (2) to compare the registration summaries of randomized trials on CTG with final published manuscripts on pertinent methodological variables. Systematic review. Two independent investigators searched ClinicalTrials.gov for all closed and completed trials related to sports medicine until June 2009 using a text search strategy. The authors then searched for publications resulting from these registered trials in peer-reviewed journals that are indexed with MEDLINE and/or EMBASE as of February 2012 based on study authors and key words provided in the study protocol. Details of primary outcomes and secondary outcomes, study sponsors, and sample size were extracted and compared between registrations and publications. Of 34 closed and completed trials registered on CTG, there were 20 resultant publications in peer-reviewed journals (58.8%). There was no significant relationship between source of funding and rate of publication (P > .05). The authors found a discrepancy between the CTG registration summary and the manuscript in at least one methodological variable (primary/secondary outcomes, inclusion/exclusion criteria, sample size) in 16 of 20 (80.0%) articles and a discrepancy in the primary outcome in 8 of 20 (40.0%) published trials. Although registration of sports medicine trials in CTG does not consistently result in publication or disclosure of results at 32 months from the time of study completion, observed publication rates are higher than in other orthopaedic subspecialties. Changes are also frequently made to the final presentation of eligibility criteria and primary and secondary outcomes that are not reflected in the registered

  7. Appropriate statistical methods were infrequently used in cluster-randomized crossover trials.

    Science.gov (United States)

    Arnup, Sarah J; Forbes, Andrew B; Kahan, Brennan C; Morgan, Katy E; McKenzie, Joanne E

    2016-06-01

    To assess the design and statistical methods used in cluster-randomized crossover (CRXO) trials. We undertook a systematic review of CRXO trials. Searches of MEDLINE, EMBASE, and CINAHL Plus; and citation searches of CRXO methodological articles were conducted to December 2014. We extracted data on design characteristics and statistical methods for sample size, data analysis, and handling of missing data. Ninety-one trials including 139 end point analyses met the inclusion criteria. Trials had a median of nine clusters [interquartile range (IQR), 4-21] and median cluster-period size of 30 individuals (IQR, 14-77); 58 (69%) trials had two periods, and 27 trials (30%) included the same individuals in all periods. A rationale for the design was reported in only 25 trials (27%). A sample size justification was provided in 53 (58%) trials. Only nine (10%) trials accounted appropriately for the design in their sample size calculation. Ten of the 12 cluster-level analyses used a method that accounted for the clustering and multiple-period aspects of the design. In contrast, only 4 of the 127 individual-level analyses used a potentially appropriate method. There is a need for improved application of appropriate analysis and sample size methods, and reporting, in CRXO trials. Copyright © 2015 Elsevier Inc. All rights reserved.

  8. The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials.

    Science.gov (United States)

    Welch, Mary Jane; Lally, Rachel; Miller, Jennifer E; Pittman, Stephanie; Brodsky, Lynda; Caplan, Arthur L; Uhlenbrauck, Gina; Louzao, Darcy M; Fischer, James H; Wilfond, Benjamin

    2015-10-01

    Policies have been developed to protect vulnerable populations in clinical research, including the US federal research regulations (45 Code of Federal Regulations 46 Subparts B, C, and D). These policies generally recognize vulnerable populations to include pregnant women, fetuses, neonates, children, prisoners, persons with physical handicaps or mental disabilities, and disadvantaged persons. The aim has been to protect these populations from harm, often by creating regulatory and ethical checks that may limit their participation in many clinical trials. The recent increase in pragmatic clinical trials raises at least two questions about this approach. First, is exclusion itself a harm to vulnerable populations, as these groups may be denied access to understanding how health interventions work for them in clinical settings? Second, are groups considered vulnerable in traditional clinical trials also vulnerable in pragmatic clinical trials? We argue first that excluding vulnerable subjects from participation in pragmatic clinical trials can be harmful by preventing acquisition of data to meaningfully inform clinical decision-making in the future. Second, we argue that protections for vulnerable subjects in traditional clinical trial settings may not be translatable, feasible, or even ethical to apply in pragmatic clinical trials. We conclude by offering specific recommendations for appropriately protecting vulnerable research subjects in pragmatic clinical trials, focusing on pregnant women, fetuses, neonates, children, prisoners, persons with physical handicaps or mental disabilities, and disadvantaged persons. © The Author(s) 2015.

  9. Association of Run-in Periods with Weight Loss in Obesity Randomized Controlled Trials

    OpenAIRE

    Affuso, Olivia; Kaiser, Kathryn A.; Carson, Tiffany L.; Ingram, Katherine H.; Schwiers, Michael; Robertson, Henry; Abbas, Firas; Allison, David B.

    2013-01-01

    Study-level design characteristics that inform the optimal design of obesity randomized controlled trials (RCTs) have been examined in few studies. A pre-randomization run-in period is one such design element that may influence weight loss. We examined 311 obesity RCTs published between January 1, 2007 and July 1, 2009 that examined weight loss or weight gain prevention as a primary or secondary endpoint. Variables included run-in period, pre-post intervention weight loss, study duration (tim...

  10. Project Management of Randomized Clinical Trials: A Narrative Review.

    Science.gov (United States)

    Goodarzynejad, Hamidreza; Babamahmoodi, Abdolreza

    2015-08-01

    A well-structured protocol for a clinical trial may be able to answer clinical questions, but it cannot be deemed enough to ensure success in the face of incompetent management of time as well as human and economic resources. To address this problem, in this article, we present our literature review on evidence as to how a good knowledge of proper management among researchers can enhance the likelihood of the success of clinical trial projects. Using multiple search strategies, we conducted a literature review on published studies in the English language from 2002 to 2012 by searching the Cochrane Database of Systematic Reviews, MEDLINE, Google Scholar, and EMBASE. Our review suggests that a successful trial requires a work plan or work scope as well as a timeline. The trial manager should subsequently manage the study in accordance with the plan and the timeline. Many research units have called for a clinical project manager with scientific background and regulatory skills to effect coordination among various aspects of a clinical trial. Project management may benefit both the managerial and scientific aspects of medical projects and reduce fund waste. However, little has been written to date on project management in the context of clinical research. The suggestions represent the views of the individual authors. To provide a high level of evidence in this regard, we recommend that a randomized controlled trial be performed to compare trial projects progressed with and without the use of project management.

  11. The Move from Accuracy Studies to Randomized Trials in PET

    DEFF Research Database (Denmark)

    Siepe, Bettina; Hoilund-Carlsen, Poul Flemming; Gerke, Oke

    2014-01-01

    Since the influential study by van Tinteren et al. published in The Lancet in 2002, there have been an increasing number of diagnostic randomized controlled trials (RCTs) investigating the benefit of PET. If they provide valid and useful information on the benefit, these studies can play an impor...... evaluation. Choice of patient-important outcomes and sufficient sample sizes are crucial issues in planning RCTs to demonstrate the clinical benefit of using PET.......Since the influential study by van Tinteren et al. published in The Lancet in 2002, there have been an increasing number of diagnostic randomized controlled trials (RCTs) investigating the benefit of PET. If they provide valid and useful information on the benefit, these studies can play...... of diagnostic randomized trials, in which PET was applied in only one arm. We covered published studies as well as registered unpublished and planned studies. We considered 3 quality indicators related to the usefulness of a trial to generate evidence for a clinical benefit: use of patient-important outcome...

  12. Assertive community treatment in the Netherlands: a randomized controlled trial.

    Science.gov (United States)

    Sytema, S; Wunderink, L; Bloemers, W; Roorda, L; Wiersma, D

    2007-08-01

    Assertive community treatment is rapidly implemented by many European mental health services, but recently the evidence base has been questioned. Positive results of randomized trials in the USA were not replicated in the UK. The question is whether the UK findings are representative for other European countries with modern mental health services. Open randomized controlled trial of long-term severely mentally ill patients [Health of the Nation Outcome Scales (HoNOS) total score >or=15], assigned to assertive community treatment (n = 59) or to standard community mental health care (n = 59). sustained contact; housing stability and admission days. This trial is registered as an International Standard Randomized Clinical Trial, number ISRCTN 11281756. Assertive community treatment was significantly better in sustaining contact with patients, but not in reducing admission days. No differences in housing stability, psychopathology, social functioning or quality of life were found. The results are in agreement with UK studies. However, the sustained contact potential of assertive community treatment is important, as too many patients are lost in standard care.

  13. Hyperoncotic colloids and acute kidney injury: a meta-analysis of randomized trials

    Science.gov (United States)

    2010-01-01

    Introduction It has been hypothesized that hyperoncotic colloids might contribute to acute kidney injury (AKI). However, the validity of this hypothesis remains unclear. Methods A meta-analysis was conducted of randomized controlled trials evaluating AKI after infusion of hyperoncotic albumin and hydroxyethyl starch (HES) solutions. Mortality was a secondary endpoint. Eligible trials were sought by multiple methods, and the pooled odds ratios (OR) for AKI and death and 95% confidence intervals (CI) were computed under a random effects model. Results Eleven randomized trials with a total of 1220 patients were included: 7 evaluating hyperoncotic albumin and 4 hyperoncotic HES. Clinical indications were ascites, surgery, sepsis and spontaneous bacterial peritonitis. Hyperoncotic albumin decreased the odds of AKI by 76% (OR, 0.24; CI, 0.12-0.48; P colloid solutions per se injure the kidney. Renal effects appear instead to be colloid-specific, with albumin displaying renoprotection and HES showing nephrotoxicity. PMID:21029460

  14. A method of extracting the number of trial participants from abstracts describing randomized controlled trials.

    Science.gov (United States)

    Hansen, Marie J; Rasmussen, Nana Ø; Chung, Grace

    2008-01-01

    We have developed a method for extracting the number of trial participants from abstracts describing randomized controlled trials (RCTs); the number of trial participants may be an indication of the reliability of the trial. The method depends on statistical natural language processing. The number of interest was determined by a binary supervised classification based on a support vector machine algorithm. The method was trialled on 223 abstracts in which the number of trial participants was identified manually to act as a gold standard. Automatic extraction resulted in 2 false-positive and 19 false-negative classifications. The algorithm was capable of extracting the number of trial participants with an accuracy of 97% and an F-measure of 0.84. The algorithm may improve the selection of relevant articles in regard to question-answering, and hence may assist in decision-making.

  15. Treating adolescents with cannabis use disorder with Multidimensional Family Therapy (MDFT): Main results of a Randomized Controlled Trial (RCT)

    NARCIS (Netherlands)

    P. Tossmann (Peter); B. Jonas (Benjamin); H. Rigter (Henk); A. Gantner (Andreas)

    2012-01-01

    textabstractAims: To determine the effectiveness of Multidimensional Family Therapy (MDFT) among adolescents with cannabis use disorder in Germany. Methods: In a randomized controlled trial (RCT), MDFT was compared with Youth Psychotherapy (JUP), an individual intervention including Cognitive

  16. Sequential multiple assignment randomization trials with enrichment design.

    Science.gov (United States)

    Liu, Ying; Wang, Yuanjia; Zeng, Donglin

    2017-06-01

    Sequential multiple assignment randomization trial (SMART) is a powerful design to study Dynamic Treatment Regimes (DTRs) and allows causal comparisons of DTRs. To handle practical challenges of SMART, we propose a SMART with Enrichment (SMARTER) design, which performs stage-wise enrichment for SMART. SMARTER can improve design efficiency, shorten the recruitment period, and partially reduce trial duration to make SMART more practical with limited time and resource. Specifically, at each subsequent stage of a SMART, we enrich the study sample with new patients who have received previous stages' treatments in a naturalistic fashion without randomization, and only randomize them among the current stage treatment options. One extreme case of the SMARTER is to synthesize separate independent single-stage randomized trials with patients who have received previous stage treatments. We show data from SMARTER allows for unbiased estimation of DTRs as SMART does under certain assumptions. Furthermore, we show analytically that the efficiency gain of the new design over SMART can be significant especially when the dropout rate is high. Lastly, extensive simulation studies are performed to demonstrate performance of SMARTER design, and sample size estimation in a scenario informed by real data from a SMART study is presented. © 2016, The International Biometric Society.

  17. Ethical issues posed by cluster randomized trials in health research

    Directory of Open Access Journals (Sweden)

    Donner Allan

    2011-04-01

    Full Text Available Abstract The cluster randomized trial (CRT is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to fulfill responsibly their respective roles. Our project will provide a systematic analysis of the ethics of cluster trials. Here we have outlined a series of six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation: 1. Who is a research subject? 2. From whom, how, and when must informed consent be obtained? 3. Does clinical equipoise apply to CRTs? 4. How do we determine if the benefits outweigh the risks of CRTs? 5. How ought vulnerable groups be protected in CRTs? 6. Who are gatekeepers and what are their responsibilities? Subsequent papers in this series will address each of these areas, clarifying the ethical issues at stake and, where possible, arguing for a preferred solution. Our hope is that these papers will serve as the basis for the creation of international ethical guidelines for the design and conduct of cluster randomized trials.

  18. Mediterranean dietary pattern and depression: the PREDIMED randomized trial

    Science.gov (United States)

    2013-01-01

    Background A few observational studies have found an inverse association between adherence to a Mediterranean diet and the risk of depression. Randomized trials with an intervention based on this dietary pattern could provide the most definitive answer to the findings reported by observational studies. The aim of this study was to compare in a randomized trial the effects of two Mediterranean diets versus a low-fat diet on depression risk after at least 3 years of intervention. Methods This was a multicenter, randomized, primary prevention field trial of cardiovascular disease (Prevención con Dieta Mediterránea (PREDIMED Study)) based on community-dwelling men aged 55 to 80 years and women aged 60 to 80 years at high risk of cardiovascular disease (51% of them had type 2 diabetes; DM2) attending primary care centers affiliated with 11 Spanish teaching hospitals. Primary analyses were performed on an intention-to-treat basis. Cox regression models were used to assess the relationship between the nutritional intervention groups and the incidence of depression. Results We identified 224 new cases of depression during follow-up. There was an inverse association with depression for participants assigned to a Mediterranean diet supplemented with nuts (multivariate hazard ratio (HR) 0.78; 95% confidence interval (CI) 0.55 to 1.10) compared with participants assigned to the control group, although this was not significant. However, when the analysis was restricted to participants with DM2, the magnitude of the effect of the intervention with the Mediterranean diet supplemented with nuts did reach statistical significance (multivariate HR = 0.59; 95% CI 0.36 to 0.98). Conclusions The result suggest that a Mediterranean diet supplemented with nuts could exert a beneficial effect on the risk of depression in patients with DM2. Trial registration This trial has been registered in the Current Controlled Trials with the number ISRCTN 35739639 PMID:24229349

  19. Ghana randomized air pollution and health study (GRAPHS): study protocol for a randomized controlled trial

    OpenAIRE

    Jack, Darby W.; Asante, Kwaku Poku; Blair J. Wylie; Chillrud, Steve N.; Whyatt, Robin M.; Ae-Ngibise, Kenneth A.; Quinn, Ashlinn K.; Yawson, Abena Konadu; Boamah, Ellen Abrafi; Agyei, Oscar; Mujtaba, Mohammed; Kaali, Seyram; Kinney, Patrick; Owusu-Agyei, Seth

    2015-01-01

    Background: Household air pollution exposure is a major health risk, but validated interventions remain elusive. Methods/Design The Ghana Randomized Air Pollution and Health Study (GRAPHS) is a cluster-randomized trial that evaluates the efficacy of clean fuels (liquefied petroleum gas, or LPG) and efficient biomass cookstoves in the Brong-Ahafo region of central Ghana. We recruit pregnant women into LPG, efficient cookstove, and control arms and track birth weight and physician-assessed seve...

  20. Quenched Large Deviations for Simple Random Walks on Percolation Clusters Including Long-Range Correlations

    Science.gov (United States)

    Berger, Noam; Mukherjee, Chiranjib; Okamura, Kazuki

    2017-12-01

    We prove a quenched large deviation principle (LDP) for a simple random walk on a supercritical percolation cluster (SRWPC) on {Z^d} ({d ≥ 2} ). The models under interest include classical Bernoulli bond and site percolation as well as models that exhibit long range correlations, like the random cluster model, the random interlacement and the vacant set of random interlacements (for {d ≥ 3} ) and the level sets of the Gaussian free field ({d≥ 3} ). Inspired by the methods developed by Kosygina et al. (Commun Pure Appl Math 59:1489-1521, 2006) for proving quenched LDP for elliptic diffusions with a random drift, and by Yilmaz (Commun Pure Appl Math 62(8):1033-1075, 2009) and Rosenbluth (Quenched large deviations for multidimensional random walks in a random environment: a variational formula. Ph.D. thesis, NYU, arXiv:0804.1444v1) for similar results regarding elliptic random walks in random environment, we take the point of view of the moving particle and prove a large deviation principle for the quenched distribution of the pair empirical measures of the environment Markov chain in the non-elliptic case of SRWPC. Via a contraction principle, this reduces easily to a quenched LDP for the distribution of the mean velocity of the random walk and both rate functions admit explicit variational formulas. The main difficulty in our set up lies in the inherent non-ellipticity as well as the lack of translation-invariance stemming from conditioning on the fact that the origin belongs to the infinite cluster. We develop a unifying approach for proving quenched large deviations for SRWPC based on exploiting coercivity properties of the relative entropies in the context of convex variational analysis, combined with input from ergodic theory and invoking geometric properties of the supercritical percolation cluster.

  1. Mortality in the Randomized, Controlled Lung Intergroup Trial of Isotretinoin

    Science.gov (United States)

    Lee, J. Jack; Feng, Lei; Reshef, Daniel S.; Sabichi, Anita L.; Williams, Brendell; Rinsurongkawong, Waree; Wistuba, Ignacio I.; Lotan, Reuben; Lippman, Scott M.

    2010-01-01

    In 2001, we reported that mortality may have been higher with isotretinoin (30 mg/d for 3 years) than with placebo in the subgroup of current smokers among the 1,166 patients with definitively resected early-stage non-small cell lung cancer who participated in the randomized, controlled Lung Intergroup Trial (LIT). Now, we report the overall and cause (cancer, cardiovascular disease, or other)-specific mortality associated with long-term isotretinoin after an extended median follow-up of 6.2 years that included the capture of cause-of-death data from 428 deceased patients. Overall mortality was 36.7% in each of the two trial arms, about two-thirds related to cancer, one-third to other or unknown causes. Overall and cancer deaths increased in current smokers in the isotretinoin arm during the treatment and the extended follow-up period. No mortality endpoint increased among never smokers and former smokers taking isotretinoin, and cancer deaths decreased marginally in this combined subgroup. Isotretinoin also increased deaths from cardiovascular disease in current smokers. The present analysis supports the safety of protracted isotretinoin use in the combined group of never smokers and former smokers, which has important public health implications, e.g., for treating acne in young people. The increased mortality in current smokers in this study is further evidence of the multifaceted danger of active smoking. The overall indications of this study have public health implications for treating acne in young people and other uses of retinoids in smokers. PMID:20501862

  2. A randomized trial of prenatal versus postnatal repair of myelomeningocele.

    Science.gov (United States)

    Adzick, N Scott; Thom, Elizabeth A; Spong, Catherine Y; Brock, John W; Burrows, Pamela K; Johnson, Mark P; Howell, Lori J; Farrell, Jody A; Dabrowiak, Mary E; Sutton, Leslie N; Gupta, Nalin; Tulipan, Noel B; D'Alton, Mary E; Farmer, Diana L

    2011-03-17

    Prenatal repair of myelomeningocele, the most common form of spina bifida, may result in better neurologic function than repair deferred until after delivery. We compared outcomes of in utero repair with standard postnatal repair. We randomly assigned eligible women to undergo either prenatal surgery before 26 weeks of gestation or standard postnatal repair. One primary outcome was a composite of fetal or neonatal death or the need for placement of a cerebrospinal fluid shunt by the age of 12 months. Another primary outcome at 30 months was a composite of mental development and motor function. The trial was stopped for efficacy of prenatal surgery after the recruitment of 183 of a planned 200 patients. This report is based on results in 158 patients whose children were evaluated at 12 months. The first primary outcome occurred in 68% of the infants in the prenatal-surgery group and in 98% of those in the postnatal-surgery group (relative risk, 0.70; 97.7% confidence interval [CI], 0.58 to 0.84; P<0.001). Actual rates of shunt placement were 40% in the prenatal-surgery group and 82% in the postnatal-surgery group (relative risk, 0.48; 97.7% CI, 0.36 to 0.64; P<0.001). Prenatal surgery also resulted in improvement in the composite score for mental development and motor function at 30 months (P=0.007) and in improvement in several secondary outcomes, including hindbrain herniation by 12 months and ambulation by 30 months. However, prenatal surgery was associated with an increased risk of preterm delivery and uterine dehiscence at delivery. Prenatal surgery for myelomeningocele reduced the need for shunting and improved motor outcomes at 30 months but was associated with maternal and fetal risks. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00060606.).

  3. Effectiveness of myofascial release: systematic review of randomized controlled trials.

    Science.gov (United States)

    Ajimsha, M S; Al-Mudahka, Noora R; Al-Madzhar, J A

    2015-01-01

    Myofascial release (MFR) is a form of manual therapy that involves the application of a low load, long duration stretch to the myofascial complex, intended to restore optimal length, decrease pain, and improve function. Anecdotal evidence shows great promise for MFR as a treatment for various conditions. However, research to support the anecdotal evidence is lacking. To critically analyze published randomized controlled trials (RCTs) to determine the effectiveness of MFR as a treatment option for different conditions. Electronic databases: MEDLINE, CINAHL, Academic Search Premier, Cochrane library, and Physiotherapy Evidence Database (PEDro), with key words myofascial release and myofascial release therapy. No date limitations were applied to the searches. Articles were selected based upon the use of the term myofascial release in the abstract or key words. The final selection was made by applying the inclusion and exclusion criteria to the full text. Studies were included if they were English-language, peer-reviewed RCTs on MFR for various conditions and pain. Data collected were number of participants, condition being treated, treatment used, control group, outcome measures and results. Studies were analyzed using the PEDro scale and the Center for Evidence-Based Medicine's Levels of Evidence scale. The literature regarding the effectiveness of MFR was mixed in both quality and results. Although the quality of the RCT studies varied greatly, the result of the studies was encouraging, particularly with the recently published studies. MFR is emerging as a strategy with a solid evidence base and tremendous potential. The studies in this review may help as a respectable base for the future trials. Copyright © 2014 Elsevier Ltd. All rights reserved.

  4. The SafeBoosC II randomized trial

    DEFF Research Database (Denmark)

    Plomgaard, Anne M; van Oeveren, Wim; Petersen, Tue Hvass

    2016-01-01

    BACKGROUND: The SafeBoosC phase II multicentre randomized clinical trial investigated the benefits and harms of monitoring cerebral oxygenation by near-infrared spectroscopy (NIRS) combined with an evidence-based treatment guideline vs. no NIRS data and treatment as usual in the control group...... during the first 72 h of life. The trial demonstrated a significant reduction in the burden of cerebral hypoxia in the experimental group. We now report the blindly assessed and analyzed treatment effects on electroencephalographic (EEG) outcomes (burst rate and spectral edge frequency 95% (SEF95...

  5. The pursuit of balance in sequential randomized trials

    Directory of Open Access Journals (Sweden)

    Raymond P. Guiteras

    2016-06-01

    Full Text Available In many randomized trials, subjects enter the sample sequentially. Because the covariates for all units are not known in advance, standard methods of stratification do not apply. We describe and assess the method of DA-optimal sequential allocation (Atkinson, 1982 for balancing stratification covariates across treatment arms. We provide simulation evidence that the method can provide substantial improvements in precision over commonly employed alternatives. We also describe our experience implementing the method in a field trial of a clean water and handwashing intervention in Dhaka, Bangladesh, the first time the method has been used. We provide advice and software for future researchers.

  6. Early vibration assisted physiotherapy in toddlers with cerebral palsy - a randomized controlled pilot trial

    NARCIS (Netherlands)

    Stark, C.; Herkenrath, P.; Hollmann, H.; Waltz, S.; Becker, I.; Hoebing, L.; Semler, O.; Hoyer-Kuhn, H.; Duran, I.; Hero, B.; Hadders-Algra, M.; Schoenau, E.

    OBJECTIVES: to investigate feasibility, safety and efficacy of home-based side-alternating whole body vibration (sWBV) to improve motor function in toddlers with cerebral palsy (CP). METHODS: Randomized controlled trial including 24 toddlers with CP (mean age 19 months (SD±3.1); 13 boys).

  7. Digestive Enzyme Supplementation for Autism Spectrum Disorders: A Double-Blind Randomized Controlled Trial

    Science.gov (United States)

    Munasinghe, Sujeeva A.; Oliff, Carolyn; Finn, Judith; Wray, John A.

    2010-01-01

    To examine the effects of a digestive enzyme supplement in improving expressive language, behaviour and other symptoms in children with Autism Spectrum Disorder. Randomized, double-blind placebo-controlled trial using crossover design over 6 months for 43 children, aged 3-8 years. Outcome measurement tools included monthly Global Behaviour Rating…

  8. Factors Influencing Hand Washing Behaviour in Primary Schools: Process Evaluation within a Randomized Controlled Trial

    Science.gov (United States)

    Chittleborough, Catherine R.; Nicholson, Alexandra L.; Basker, Elaine; Bell, Sarah; Campbell, Rona

    2012-01-01

    This article explores factors that may influence hand washing behaviour among pupils and staff in primary schools. A qualitative process evaluation within a cluster randomized controlled trial included pupil focus groups (n = 16, aged 6-11 years), semi-structured interviews (n = 16 teachers) and observations of hand washing facilities (n = 57).…

  9. Shared Care in Monitoring Stable Glaucoma Patients: A Randomized Controlled Trial

    NARCIS (Netherlands)

    Holtzer-Goor, Kim M.; van Vliet, Ellen J.; van Sprundel, Esther; Plochg, Thomas; Koopmanschap, Marc A.; Klazinga, Niek S.; Lemij, Hans G.

    2016-01-01

    Comparing the quality of care provided by a hospital-based shared care glaucoma follow-up unit with care as usual. This randomized controlled trial included stable glaucoma patients and patients at risk for developing glaucoma. Patients in the Usual Care group (n=410) were seen by glaucoma

  10. Myopia Control with Bifocal Contact Lenses: A Randomized Clinical Trial.

    Science.gov (United States)

    Aller, Thomas A; Liu, Maria; Wildsoet, Christine F

    2016-04-01

    Most studies have reported only minimal reductions in myopia progression with bifocal or progressive multifocal spectacles, although somewhat larger, although mostly still clinically insignificant, effects have been reported in children with nearpoint esophoria and/or accommodative dysfunctions. The CONTROL study was a 1-year, prospective, randomized, clinical trial of bifocal contact lenses for control of myopia in children with eso fixation disparities at near. Eighty-six myopic subjects, aged 8 to 18 years, were enrolled in the study after passing the screening examination. Of these, 79 completed lens assignment and 78 completed the study. The mean refractive error of these 79 subjects was -2.69 ± 1.40D (SD), and all had progressed by -0.50D or more since their last examination. All subjects also had eso fixation disparity at near. Subjects were randomly assigned to wear either Vistakon Acuvue 2 (single-vision soft contact lenses [SVSCLs]) or Vistakon Acuvue Bifocal (bifocal soft contact lenses [BFSCLs]). Bifocal adds were selected to neutralize the associated phoria. Treatment outcomes included cycloplegic autorefraction and axial length, assessed in terms of changes after 6 and 12 months of treatment from pretreatment baseline values. The BFSCLs significantly slowed myopia progression, with statistically significant differences between the treatment groups after 6 months. After 12 months of treatment, the SVSCL group had progressed by -0.79 ± 0.43D compared with -0.22 ± 0.34D for the BFSCL group (cycloplegic objective spherical equivalent, average of two eyes). Corresponding axial length changes were 0.24 ± 0.17 mm and 0.05 ± 0.14 mm, respectively. All of these differences were found to be statistically significant (unpaired t-tests, p 70%) compared with most published results with multifocal spectacles. Further studies are warranted to identify the critical factors and mechanisms underlying this myopia control effect.

  11. Computerized tailored physical activity reports. A randomized controlled trial.

    Science.gov (United States)

    Carroll, Jennifer K; Lewis, Beth A; Marcus, Bess H; Lehman, Erik B; Shaffer, Michele L; Sciamanna, Christopher N

    2010-08-01

    Computerized, tailored interventions have the potential to be a cost-effective means to assist a wide variety of individuals with behavior change. This study examined the effect of computerized tailored physical activity reports on primary care patients' physical activity at 6 months. Two-group randomized clinical trial with physicians as the unit of randomization. Patients were placed in the intervention (n=187) or control group (n=207) based on their physician's assignment. Primary care physicians (n=22) and their adult patients (n=394) from Philadelphia PA. The study and analyses were conducted from 2004 to 2010. The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription. The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions. Minutes of physical activity measured by the 7-Day Physical Activity Recall interview at 6 months. Participants were 69% female, 59% African-American, and had diverse educational and income levels; the retention rate was 89.6%. After adjusting for baseline levels of activity and gender, there were no differences in physical activity at 6 months. The intervention group increased their total physical activity by a mean of 139 minutes; the control group had a mean increase of 109 minutes (p=0.45). Although physical activity increased within both groups, computerized tailored physical activity reports did not significantly increase physical activity between groups at 6 months among ethnically and socioeconomically diverse adults in primary care. 2010 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

  12. Empowerment Program for People With Prediabetes: A Randomized Controlled Trial.

    Science.gov (United States)

    Chen, Mei-Fang; Hung, Shu-Ling; Chen, Shu-Lin

    2017-04-01

    Practicing a health-promoting lifestyle is believed to be effective for delaying or preventing the onset of diabetes. However, although empowerment interventions have proven effective for encouraging the adoption of a health-promoting lifestyle in people with diabetes, these interventions are rarely promoted to people with prediabetes. The aims of this study were to develop an empowerment program for people with prediabetes and to examine its efficacy in terms of the adoption of a health-promoting lifestyle and improvements in blood sugar, body mass index, and self-efficacy. A randomized controlled trial was conducted between May and December 2013. A convenience sample of people with a fasting blood sugar level of 100-125 mg/dl during the previous 3 months was recruited from the health examination center of a hospital in Kaohsiung, Taiwan. Participants were assigned to either the experimental group or the control group using block randomization with a block size of 8. The experimental group (n = 38) participated in a 4-month empowerment program (the ABC empowerment program), which encouraged participants to practice a health-promoting lifestyle in three phases: awareness raising, behavior building, and results checking. The control group (n = 40) received routine clinical care. Statistical analyses included descriptive statistics, independent t test, paired t test, and generalized estimated equations. After controlling for the differences at baseline and considering the interaction between group and time from baseline to 1 week and 3 months after completing the intervention, the generalized estimating equation showed significantly larger improvements in a health-promoting lifestyle, blood sugar, and self-efficacy in the experimental group than in the control group (p empowerment program was shown to have short-term, positive effects on behavioral, physical, and psychosocial outcomes in a Taiwan population with prediabetes. The results of this study provide a useful

  13. Cluster randomized trials in comparative effectiveness research: randomizing hospitals to test methods for prevention of healthcare-associated infections.

    Science.gov (United States)

    Platt, Richard; Takvorian, Samuel U; Septimus, Edward; Hickok, Jason; Moody, Julia; Perlin, Jonathan; Jernigan, John A; Kleinman, Ken; Huang, Susan S

    2010-06-01

    The need for evidence about the effectiveness of therapeutics and other medical practices has triggered new interest in methods for comparative effectiveness research. Describe an approach to comparative effectiveness research involving cluster randomized trials in networks of hospitals, health plans, or medical practices with centralized administrative and informatics capabilities. We discuss the example of an ongoing cluster randomized trial to prevent methicillin-resistant Staphylococcus aureus (MRSA) infection in intensive care units (ICUs). The trial randomizes 45 hospitals to: (a) screening cultures of ICU admissions, followed by Contact Precautions if MRSA-positive, (b) screening cultures of ICU admissions followed by decolonization if MRSA-positive, or (c) universal decolonization of ICU admissions without screening. All admissions to adult ICUs. The primary outcome is MRSA-positive clinical cultures occurring >or=2 days following ICU admission. Secondary outcomes include blood and urine infection caused by MRSA (and, separately, all pathogens), as well as the development of resistance to decolonizing agents. Recruitment of hospitals is complete. Data collection will end in Summer 2011. This trial takes advantage of existing personnel, procedures, infrastructure, and information systems in a large integrated hospital network to conduct a low-cost evaluation of prevention strategies under usual practice conditions. This approach is applicable to many comparative effectiveness topics in both inpatient and ambulatory settings.

  14. Caffeine for treatment of Parkinson disease: a randomized controlled trial.

    Science.gov (United States)

    Postuma, Ronald B; Lang, Anthony E; Munhoz, Renato P; Charland, Katia; Pelletier, Amelie; Moscovich, Mariana; Filla, Luciane; Zanatta, Debora; Rios Romenets, Silvia; Altman, Robert; Chuang, Rosa; Shah, Binit

    2012-08-14

    Epidemiologic studies consistently link caffeine, a nonselective adenosine antagonist, to lower risk of Parkinson disease (PD). However, the symptomatic effects of caffeine in PD have not been adequately evaluated. We conducted a 6-week randomized controlled trial of caffeine in PD to assess effects upon daytime somnolence, motor severity, and other nonmotor features. Patients with PD with daytime somnolence (Epworth >10) were given caffeine 100 mg twice daily ×3 weeks, then 200 mg twice daily ×3 weeks, or matching placebo. The primary outcome was the Epworth Sleepiness Scale score. Secondary outcomes included motor severity, sleep markers, fatigue, depression, and quality of life. Effects of caffeine were analyzed with Bayesian hierarchical models, adjusting for study site, baseline scores, age, and sex. Of 61 patients, 31 were randomized to placebo and 30 to caffeine. On the primary intention-to-treat analysis, caffeine resulted in a nonsignificant reduction in Epworth Sleepiness Scale score (-1.71 points; 95% confidence interval [CI] -3.57, 0.13). However, somnolence improved on the Clinical Global Impression of Change (+0.64; 0.16, 1.13, intention-to-treat), with significant reduction in Epworth Sleepiness Scale score on per-protocol analysis (-1.97; -3.87, -0.05). Caffeine reduced the total Unified Parkinson's Disease Rating Scale score (-4.69 points; -7.7, -1.6) and the objective motor component (-3.15 points; -5.50, -0.83). Other than modest improvement in global health measures, there were no changes in quality of life, depression, or sleep quality. Adverse events were comparable in caffeine and placebo groups. Caffeine provided only equivocal borderline improvement in excessive somnolence in PD, but improved objective motor measures. These potential motor benefits suggest that a larger long-term trial of caffeine is warranted. This study provides Class I evidence that caffeine, up to 200 mg BID for 6 weeks, had no significant benefit on excessive daytime

  15. Randomized controlled trials in central vascular access devices: A scoping review

    Science.gov (United States)

    Keogh, Samantha; Rickard, Claire M.

    2017-01-01

    Background Randomized controlled trials evaluate the effectiveness of interventions for central venous access devices, however, high complication rates remain. Scoping reviews map the available evidence and demonstrate evidence deficiencies to focus ongoing research priorities. Method A scoping review (January 2006–December 2015) of randomized controlled trials evaluating the effectiveness of interventions to improve central venous access device outcomes; including peripherally inserted central catheters, non-tunneled, tunneled and totally implanted venous access catheters. MeSH terms were used to undertake a systematic search with data extracted by two independent researchers, using a standardized data extraction form. Results In total, 178 trials were included (78 non-tunneled [44%]; 40 peripherally inserted central catheters [22%]; 20 totally implanted [11%]; 12 tunneled [6%]; 6 non-specified [3%]; and 22 combined device trials [12%]). There were 119 trials (68%) involving adult participants only, with 18 (9%) pediatric and 20 (11%) neonatal trials. Insertion-related themes existed in 38% of trials (67 RCTs), 35 RCTs (20%) related to post-insertion patency, with fewer trials on infection prevention (15 RCTs, 8%), education (14RCTs, 8%), and dressing and securement (12 RCTs, 7%). There were 46 different study outcomes reported, with the most common being infection outcomes (161 outcomes; 37%), with divergent definitions used for catheter-related bloodstream and other infections. Conclusion More high quality randomized trials across central venous access device management are necessary, especially in dressing and securement and patency. These can be encouraged by having more studies with multidisciplinary team involvement and consumer engagement. Additionally, there were extensive gaps within population sub-groups, particularly in tunneled devices, and in pediatrics and neonates. Finally, outcome definitions need to be unified for results to be meaningful and

  16. A randomized trial of calorie labeling on menus.

    Science.gov (United States)

    Hammond, David; Goodman, Samantha; Hanning, Rhona; Daniel, Samantha

    2013-12-01

    Food consumed outside the home accounts for a growing proportion of the North American diet and has been associated with increased obesity. To examine the effect of nutrition labeling on menus on awareness, use, and food consumption, including the impact of "traffic light" labeling and adding other nutrients. Blinded, randomized trial with 635 Canadian adults conducted in 2010-2011. Participants ordered a free meal from one of four experimental menus: 1) no nutritional information shown, 2) calorie amounts only, 3) calorie amounts in "traffic lights", and 4) calorie, fat, sodium, and sugar shown in "traffic lights". Recall of nutrition information, knowledge of calorie content and nutrient consumption were assessed. Participants in the calorie conditions were more likely to recall the calorie content of meals and to report using nutrition information when ordering. The calorie content of meals was not significantly different across conditions; however, calorie consumption was significantly lower among participants in the Calorie-only condition compared to the No information condition (mean=-96 kcal, p=.048). Menu labeling increased awareness and use of nutrition information and reduced consumption. Adding "traffic lights", fat, sodium, and sugar amounts to menus had little impact compared to calorie-only labeling. © 2013.

  17. Reducing mucus production after urinary reconstruction: a prospective randomized trial.

    Science.gov (United States)

    N'Dow, J; Robson, C N; Matthews, J N; Neal, D E; Pearson, J P

    2001-05-01

    After transposition into the urinary tract, intestinal segments continue to produce mucus. We determine the effectiveness of muco-regulatory drugs, including N-acetylcysteine, aspirin and ranitidine, in reducing mucus secretion and urine viscosity in patients with transposed segments. Our trial was a prospective randomized, double-blind placebo controlled crossover study involving 12 patients who underwent ileal conduit and 31 who underwent bladder reconstruction. Each treatment lasted 3 weeks with a 2-week washout. Pretreatment and posttreatment 24-hour urine samples were analyzed for mucin and viscosity after papain digestion, sodium dodecyl sulfate-polyacrylamide gel electrophoresis and periodic acid-Schiff assay. A disease specific questionnaire and SF-36 quality of life survey were completed. According to the questionnaire, mucus production did not decrease with time in 67% of patients. Mucin comprised 3% of the total nondialyzable material in urine (65 mg./24-hour for ileal conduit and 60 mg./24-hour for bladder reconstruction). Analysis of questionnaires and laboratory results failed to demonstrate any benefit of taking muco-regulatory agents compared with placebo. The use of N-acetylcysteine, aspirin and ranitidine did not result in a reduction in mucin production, urine viscosity or improvement in quality of life.

  18. Decision Aids Can Support Cancer Clinical Trials Decisions: Results of a Randomized Trial.

    Science.gov (United States)

    Politi, Mary C; Kuzemchak, Marie D; Kaphingst, Kimberly A; Perkins, Hannah; Liu, Jingxia; Byrne, Margaret M

    2016-12-01

    Cancer patients often do not make informed decisions regarding clinical trial participation. This study evaluated whether a web-based decision aid (DA) could support trial decisions compared with our cancer center's website. Adults diagnosed with cancer in the past 6 months who had not previously participated in a cancer clinical trial were eligible. Participants were randomized to view the DA or our cancer center's website (enhanced usual care [UC]). Controlling for whether participants had heard of cancer clinical trials and educational attainment, multivariable linear regression examined group on knowledge, self-efficacy for finding trial information, decisional conflict (values clarity and uncertainty), intent to participate, decision readiness, and trial perceptions. Two hundred patients (86%) consented between May 2014 and April 2015. One hundred were randomized to each group. Surveys were completed by 87 in the DA group and 90 in the UC group. DA group participants reported clearer values regarding trial participation than UC group participants reported (least squares [LS] mean = 15.8 vs. 32, p trial participation among cancer patients facing this preference-sensitive choice. Although better informing patients before trial participation could improve retention, more work is needed to examine DA impact on enrollment and retention. This paper describes evidence regarding a decision tool to support patients' decisions about trial participation. By improving knowledge, helping patients clarify preferences for participation, and facilitating conversations about trials, decision aids could lead to decisions about participation that better match patients' preferences, promoting patient-centered care and the ethical conduct of clinical research. ©AlphaMed Press.

  19. Levocarnitine Decreases Intradialytic Hypotension Episodes: A Randomized Controlled Trial.

    Science.gov (United States)

    Ibarra-Sifuentes, Héctor Raúl; Del Cueto-Aguilera, Ángel; Gallegos-Arguijo, Daniel Alberto; Castillo-Torres, Sergio Andres; Vera-Pineda, Raymundo; Martínez-Granados, Rolando Jacob; Atilano-Díaz, Alexandro; Cuellar-Monterrubio, Jesus Eduardo; Pezina-Cantú, Cesar Octaviano; Martínez-Guevara, Edgar de Jesús; Ortiz-Treviño, Juan Francisco; Delgado-García, Guillermo Rubén; Martínez-Jiménez, José Guadalupe; Cruz-Valdez, Jesús; Sánchez-Martínez, Concepción

    2017-10-01

    Intradialytic hypotension is common complication in stage 5 chronic kidney disease patients on hemodialysis. Incidence ranges from 15 to 30%. These patients have levocarnitine deficiency. A randomized, placebo-controlled quadruple-blinded trial was designed to demonstrate the levocarnitine efficiency on intradialytic hypotension prevention. Patients were randomized into four groups, to receive levocarnitine or placebo. During the intervention period, levocarnitine and placebo was administered 0 and 30 min before each hemodialysis session, respectively. During the trial, 33 patients received 1188 hemodialysis sessions. We identified 239 (21.3%) intradialytic hypotension episodes. The intradialytic hypotension episodes were less frequent in the levocarnitine group (9.3%, 60 IH events) (P hypotension episodes. Levocarnitine supplementation before each hemodialysis session efficiently diminishes the intradialytic hypotension episodes. This is a new application method that must be considered and explored. © 2017 International Society for Apheresis, Japanese Society for Apheresis, and Japanese Society for Dialysis Therapy.

  20. Dilatation or no dilatation of the cervix during cesarean section (Dondi Trial): a randomized controlled trial.

    Science.gov (United States)

    Kirscht, Jade; Weiss, Christel; Nickol, Jana; Berlit, Sebastian; Tuschy, Benjamin; Hoch, Benjamin; Trebin, Amelie-Verena; Große-Steffen, Thomas; Sütterlin, Marc; Kehl, Sven

    2017-01-01

    To assess the effects of mechanical dilatation of the cervix during cesarean section on postoperative morbidity. A total of 447 women with elective cesarean section were included in the Dondi trial (Dilatation or no dilatation of the cervix during cesarean section). The primary outcome measure of this randomized controlled trial was postpartum hemorrhage (PPH) within 6 weeks. Infectious morbidity (puerperal fever, endometritis, wound infection, and urinary tract infection), blood loss (need for blood transfusion or change in hemoglobin levels), and operating time were also evaluated. The rate of PPH within 6 weeks was not different between the two groups [dilatation group: 5 (2.4 %), no dilatation group: 3 (1.2 %), p = 0.479]. Infectious morbidity, blood loss, and operating time were not diverse as well. The only significant difference between the two groups was the rate of retained products of conception with fewer cases after cervical dilatation (0 versus 6.2 %, p Dilatation of the cervix during cesarean section compared with no dilatation of the cervix did not influence the risk of postpartum hemorrhage. However, there were fewer cases with retained products of conception after dilatation.

  1. Comparing cluster-level dynamic treatment regimens using sequential, multiple assignment, randomized trials: Regression estimation and sample size considerations.

    Science.gov (United States)

    NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel

    2017-08-01

    Cluster-level dynamic treatment regimens can be used to guide sequential treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level dynamic treatment regimen, the treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including aggregate measures of the individuals or patients that compose it. Cluster-randomized sequential multiple assignment randomized trials can be used to answer multiple open questions preventing scientists from developing high-quality cluster-level dynamic treatment regimens. In a cluster-randomized sequential multiple assignment randomized trial, sequential randomizations occur at the cluster level and outcomes are observed at the individual level. This manuscript makes two contributions to the design and analysis of cluster-randomized sequential multiple assignment randomized trials. First, a weighted least squares regression approach is proposed for comparing the mean of a patient-level outcome between the cluster-level dynamic treatment regimens embedded in a sequential multiple assignment randomized trial. The regression approach facilitates the use of baseline covariates which is often critical in the analysis of cluster-level trials. Second, sample size calculators are derived for two common cluster-randomized sequential multiple assignment randomized trial designs for use when the primary aim is a between-dynamic treatment regimen comparison of the mean of a continuous patient-level outcome. The methods are motivated by the Adaptive Implementation of Effective Programs Trial which is, to our knowledge, the first-ever cluster-randomized sequential multiple assignment randomized trial in psychiatry.

  2. [Randomized controlled trials terminated prematurely: beneficial therapy effects].

    Science.gov (United States)

    Kluth, L A; Rink, M; Ahyai, S A; Fisch, M; Shariat, S F; Dahm, P

    2013-08-01

    Randomized controlled trials (RCTs) stopped prematurely for beneficial therapy effects are becoming increasingly more prevalent in the urological literature and often receive great attention in the public and medical media. Urologists who practice evidence-based medicine should be aware of the potential bias and the different reasons why and how early termination of RCTs can and will affect the results. This review provides insights into the challenges clinical urologists face by interpreting the results of prematurely terminated RCTs.

  3. Ear Acupuncture for Acute Sore Throat: A Randomized Controlled Trial

    Science.gov (United States)

    2014-09-26

    SEP 2014 2. REPORT TYPE Final 3. DATES COVERED 4. TITLE AND SUBTITLE Ear acupuncture for acute sore throat. A randomized controlled trial...Auncular Acupuncture is a low risk option for acute pain control •Battlefield acupuncture (BFA) IS a specific auncular acupuncture technique •BFA IS...Strengths: Prospect1ve RCT •Weaknesses Small sample stze. no sham acupuncture performed, patients not blinded to treatment •Th1s study represents an

  4. The fragility of significant results underscores the need of larger randomized controlled trials in nephrology.

    Science.gov (United States)

    Shochet, Lani R; Kerr, Peter G; Polkinghorne, Kevan R

    2017-07-26

    The Fragility Index is a tool for testing robustness of randomized controlled trial results for dichotomous outcomes. It describes the minimum number of individuals in whom changing an event status would render a statistically significant result nonsignificant. Here we identified all randomized controlled trials in five nephrology and five general journals from 2005-2014. A total of 127 randomized controlled trials reporting at least one dichotomous statistically significant outcome (p less than 0.05) were included and the Fragility Index was calculated. Twenty randomized controlled trials had a Fragility Index of zero and were excluded from further analysis. Linear regression was performed to assess factors associated with Fragility Indexes stratified by primary or secondary outcomes. The median sample size was 134 (range 2211506) with 36 (range 5-2743) total number of events. The median Fragility Index was three (range 1-166), indicating that in half the trials the addition of three events to the treatment with the lowest number of events rendered the result nonsignificant. For primary outcome studies a doubling in total event number and sample size significantly increased the geometric mean Fragility Index by 52% and 42%, respectively. Compared to a reported p value of 0.05 to 0.01, those reporting 0.01 to 0.001 or less than 0.001 had a significant 57% and 472% increase in the median Fragility Index, respectively. Forty-one percent had a Fragility Index less than the total loss to follow-up, indicating a potential to change a trial result had all individuals been accounted for. Thus, our study highlights the need for larger randomized controlled trials with accurate accounting for loss to follow-up to adequately guide evidence-based practice. Copyright © 2017 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.

  5. External validity of randomized controlled trials in older adults, a systematic review.

    Directory of Open Access Journals (Sweden)

    Floor J van Deudekom

    Full Text Available To critically assess the external validity of randomized controlled trials (RCTs it is important to know what older adults have been enrolled in the trials. The aim of this systematic review is to study what proportion of trials specifically designed for older patients report on somatic status, physical and mental functioning, social environment and frailty in the patient characteristics.PubMed was searched for articles published in 2012 and only RCTs were included. Articles were further excluded if not conducted with humans or only secondary analyses were reported. A random sample of 10% was drawn. The current review analyzed this random sample and further selected trials when the reported mean age was ≥ 60 years. We extracted geriatric assessments from the population descriptives or the in- and exclusion criteria.In total 1396 trials were analyzed and 300 trials included. The median of the reported mean age was 66 (IQR 63-70 and the median percentage of men in the trials was 60 (IQR 45-72. In 34% of the RCTs specifically designed for older patients somatic status, physical and mental functioning, social environment or frailty were reported in the population descriptives or the in- and exclusion criteria. Physical and mental functioning was reported most frequently (22% and 14%. When selecting RCTs on a mean age of 70 or 80 years the report of geriatric assessments in the patient characteristics was 46% and 85% respectively but represent only 5% and 1% of the trials.Somatic status, physical and mental functioning, social environment and frailty are underreported even in RCTs specifically designed for older patients published in 2012. Therefore, it is unclear for clinicians to which older patients the results can be applied. We recommend systematic to transparently report these relevant characteristics of older participants included in RCTs.

  6. Saffron (Crocus sativus L.) and major depressive disorder: a meta-analysis of randomized clinical trials.

    Science.gov (United States)

    Hausenblas, Heather Ann; Saha, Debbie; Dubyak, Pamela Jean; Anton, Stephen Douglas

    2013-11-01

    Due to safety concerns and side effects of many antidepressant medications, herbal psychopharmacology research has increased, and herbal remedies are becoming increasingly popular as alternatives to prescribed medications for the treatment of major depressive disorder (MDD). Of these, accumulating trials reveal positive effects of the spice saffron (Crocus sativus L.) for the treatment of depression. A comprehensive and statistical review of the clinical trials examining the effects of saffron for treatment of MDD is warranted. The purpose of this study was to conduct a meta-analysis of published randomized controlled trials examining the effects of saffron supplementation on symptoms of depression among participants with MDD. We conducted electronic and non-electronic searches to identify all relevant randomized, double-blind controlled trials. Reference lists of all retrieved articles were searched for relevant studies. The criteria for study selection included the following: (1) adults (aged 18 and older) with symptoms of depression, (2) randomized controlled trial, (3) effects of saffron supplementation on depressive symptoms examined, and (4) study had either a placebo control or antidepressant comparison group. Using random effects modeling procedures, we calculated weighted mean effect sizes separately for the saffron supplementation vs placebo control groups, and for the saffron supplementation vs antidepressant groups. The methodological quality of all studies was assessed using the Jadad score. The computer software Comprehensive Meta-analysis 2 was used to analyze the data. Based on our pre-specified criteria, five randomized controlled trials (n = 2 placebo controlled trials, n = 3 antidepressant controlled trials) were included in our review. A large effect size was found for saffron supplementation vs placebo control in treating depressive symptoms (M ES = 1.62, P saffron supplementation significantly reduced depression symptoms compared to the

  7. Meditation for migraines: a pilot randomized controlled trial.

    Science.gov (United States)

    Wells, Rebecca Erwin; Burch, Rebecca; Paulsen, Randall H; Wayne, Peter M; Houle, Timothy T; Loder, Elizabeth

    2014-10-01

    Our objective was to assess the safety, feasibility, and effects of the standardized 8-week mindfulness-based stress reduction (MBSR) course in adults with migraines. Stress is a well-known trigger for headaches. Research supports the general benefits of mind/body interventions for migraines, but there are few rigorous studies supporting the use of specific standardized interventions. MBSR is a standardized 8-week mind/body intervention that teaches mindfulness meditation/yoga. Preliminary research has shown MBSR to be effective for chronic pain syndromes, but it has not been evaluated for migraines. We conducted a randomized controlled trial with 19 episodic migraineurs randomized to either MBSR (n = 10) or usual care (n = 9). Our primary outcome was change in migraine frequency from baseline to initial follow-up. Secondary outcomes included change in headache severity, duration, self-efficacy, perceived stress, migraine-related disability/impact, anxiety, depression, mindfulness, and quality of life from baseline to initial follow-up. MBSR was safe (no adverse events), with 0% dropout and excellent adherence (daily meditation average: 34 ± 11 minutes, range 16-50 minutes/day). Median class attendance from 9 classes (including retreat day) was 8 (range [3, 9]); average class attendance was 6.7 ± 2.5. MBSR participants had 1.4 fewer migraines/month (MBSR: 3.5 to 1.0 vs control: 1.2 to 0 migraines/month, 95% confidence interval CI [-4.6, 1.8], P = .38), an effect that did not reach statistical significance in this pilot sample. Headaches were less severe, although not significantly so (-1.3 points/headache on 0-10 scale, [-2.3, 0.09], P = .053) and shorter (-2.9 hours/headache, [-4.6, -0.02], P = .043) vs control. Migraine Disability Assessment and Headache Impact Test-6 dropped in MBSR vs control (-12.6, [-22.0, -1.0], P = .017 and -4.8, [-11.0, -1.0], P = .043, respectively). Self-efficacy and mindfulness improved in MBSR vs control (13.2 [1.0, 30.0], P

  8. Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bouwense Stefan A

    2012-11-01

    Full Text Available Abstract Background After an initial attack of biliary pancreatitis, cholecystectomy minimizes the risk of recurrent biliary pancreatitis and other gallstone-related complications. Guidelines advocate performing cholecystectomy within 2 to 4 weeks after discharge for mild biliary pancreatitis. During this waiting period, the patient is at risk of recurrent biliary events. In current clinical practice, surgeons usually postpone cholecystectomy for 6 weeks due to a perceived risk of a more difficult dissection in the early days following pancreatitis and for logistical reasons. We hypothesize that early laparoscopic cholecystectomy minimizes the risk of recurrent biliary pancreatitis or other complications of gallstone disease in patients with mild biliary pancreatitis without increasing the difficulty of dissection and the surgical complication rate compared with interval laparoscopic cholecystectomy. Methods/Design PONCHO is a randomized controlled, parallel-group, assessor-blinded, superiority multicenter trial. Patients are randomly allocated to undergo early laparoscopic cholecystectomy, within 72 hours after randomization, or interval laparoscopic cholecystectomy, 25 to 30 days after randomization. During a 30-month period, 266 patients will be enrolled from 18 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite endpoint of mortality and acute re-admissions for biliary events (that is, recurrent biliary pancreatitis, acute cholecystitis, symptomatic/obstructive choledocholithiasis requiring endoscopic retrograde cholangiopancreaticography including cholangitis (with/without endoscopic sphincterotomy, and uncomplicated biliary colics occurring within 6 months following randomization. Secondary endpoints include the individual endpoints of the composite endpoint, surgical and other complications, technical difficulty of cholecystectomy and costs. Discussion The PONCHO trial is designed to show that early

  9. Sexual assault resistance education for university women: study protocol for a randomized controlled trial (SARE trial).

    Science.gov (United States)

    Senn, Charlene Y; Eliasziw, Misha; Barata, Paula C; Thurston, Wilfreda E; Newby-Clark, Ian R; Radtke, H Lorraine; Hobden, Karen L

    2013-05-23

    More than one in six women will be sexually assaulted in their lifetimes, most by men they know. The situation on university campuses is even more startling, with as many as 1 in 4 female students being victims of rape or attempted rape. The associated physical and mental health effects are extensive and the social and economic costs are staggering. The aim of this randomized controlled trial is to determine whether a novel, small-group sexual assault resistance education program can reduce the incidence of sexual assault among university-attending women, when compared to current university practice of providing informational brochures. The trial will evaluate a theoretically and empirically sound four-unit, 12-hour education program that has been demonstrated in pilot studies to have short-term efficacy. Three of the four units provide information, skills, and practice aimed at decreasing the time needed for women to assess situations with elevated risk of acquaintance sexual assault as dangerous and to take action, reducing emotional obstacles to taking action, and increasing the use of the most effective methods of verbal and physical self-defense. The fourth unit focuses on facilitating a stronger positive sexuality from which women may resist sexual coercion by male intimates more successfully. The trial will extend the pilot evaluations by expanding the participant pool and examining the long term efficacy of the program. A total of 1716 first-year female students (age 17 to 24 years) from three Canadian universities will be enrolled. The primary outcome is completed sexual assault, measured by The Sexual Experiences Survey - Short Form Victimization instrument. Secondary outcomes include changes in knowledge, attitudes, and skills related to the process of sexual assault resistance. Outcomes will be measured at baseline, 1 week, 6, 12, 18, and 24 months. The results of the trial will be used to produce a maximally effective sexual assault resistance

  10. Anaesthesiological strategies in elective craniotomy: randomized, equivalence, open trial – The NeuroMorfeo trial

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    Guzzetti Stefano

    2009-04-01

    Full Text Available Abstract Background Many studies have attempted to determine the "best" anaesthetic technique for neurosurgical procedures in patients without intracranial hypertension. So far, no study comparing intravenous (IA with volatile-based neuroanaesthesia (VA has been able to demonstrate major outcome differences nor a superiority of one of the two strategies in patients undergoing elective supratentorial neurosurgery. Therefore, current practice varies and includes the use of either volatile or intravenous anaesthetics in addition to narcotics. Actually the choice of the anaestesiological strategy depends only on the anaesthetists' preferences or institutional policies. This trial, named NeuroMorfeo, aims to assess the equivalence between volatile and intravenous anaesthetics for neurosurgical procedures. Methods/Design NeuroMorfeo is a multicenter, randomized, open label, controlled trial, based on an equivalence design. Patients aged between 18 and 75 years, scheduled for elective craniotomy for supratentorial lesion without signs of intracranial hypertension, in good physical state (ASA I-III and Glasgow Coma Scale (GCS equal to 15, are randomly assigned to one of three anaesthesiological strategies (two VA arms, sevoflurane + fentanyl or sevoflurane + remifentanil, and one IA, propofol + remifentanil. The equivalence between intravenous and volatile-based neuroanaesthesia will be evaluated by comparing the intervals required to reach, after anaesthesia discontinuation, a modified Aldrete score ≥ 9 (primary end-point. Two statistical comparisons have been planned: 1 sevoflurane + fentanyl vs. propofol + remifentanil; 2 sevoflurane + remifentanil vs. propofol + remifentanil. Secondary end-points include: an assessment of neurovegetative stress based on (a measurement of urinary catecholamines and plasma and urinary cortisol and (b estimate of sympathetic/parasympathetic balance by power spectrum analyses of electrocardiographic tracings recorded

  11. Reporting methods of blinding in randomized trials assessing nonpharmacological treatments.

    Directory of Open Access Journals (Sweden)

    Isabelle Boutron

    2007-02-01

    Full Text Available BACKGROUND: Blinding is a cornerstone of treatment evaluation. Blinding is more difficult to obtain in trials assessing nonpharmacological treatment and frequently relies on "creative" (nonstandard methods. The purpose of this study was to systematically describe the strategies used to obtain blinding in a sample of randomized controlled trials of nonpharmacological treatment. METHODS AND FINDINGS: We systematically searched in Medline and the Cochrane Methodology Register for randomized controlled trials (RCTs assessing nonpharmacological treatment with blinding, published during 2004 in high-impact-factor journals. Data were extracted using a standardized extraction form. We identified 145 articles, with the method of blinding described in 123 of the reports. Methods of blinding of participants and/or health care providers and/or other caregivers concerned mainly use of sham procedures such as simulation of surgical procedures, similar attention-control interventions, or a placebo with a different mode of administration for rehabilitation or psychotherapy. Trials assessing devices reported various placebo interventions such as use of sham prosthesis, identical apparatus (e.g., identical but inactivated machine or use of activated machine with a barrier to block the treatment, or simulation of using a device. Blinding participants to the study hypothesis was also an important method of blinding. The methods reported for blinding outcome assessors relied mainly on centralized assessment of paraclinical examinations, clinical examinations (i.e., use of video, audiotape, photography, or adjudications of clinical events. CONCLUSIONS: This study classifies blinding methods and provides a detailed description of methods that could overcome some barriers of blinding in clinical trials assessing nonpharmacological treatment, and provides information for readers assessing the quality of results of such trials.

  12. Statistical analysis plan for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART). A randomized controlled trial.

    Science.gov (United States)

    Damiani, Lucas Petri; Berwanger, Otavio; Paisani, Denise; Laranjeira, Ligia Nasi; Suzumura, Erica Aranha; Amato, Marcelo Britto Passos; Carvalho, Carlos Roberto Ribeiro; Cavalcanti, Alexandre Biasi

    2017-01-01

    The Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) is an international multicenter randomized pragmatic controlled trial with allocation concealment involving 120 intensive care units in Brazil, Argentina, Colombia, Italy, Poland, Portugal, Malaysia, Spain, and Uruguay. The primary objective of ART is to determine whether maximum stepwise alveolar recruitment associated with PEEP titration, adjusted according to the static compliance of the respiratory system (ART strategy), is able to increase 28-day survival in patients with acute respiratory distress syndrome compared to conventional treatment (ARDSNet strategy). To describe the data management process and statistical analysis plan. The statistical analysis plan was designed by the trial executive committee and reviewed and approved by the trial steering committee. We provide an overview of the trial design with a special focus on describing the primary (28-day survival) and secondary outcomes. We describe our data management process, data monitoring committee, interim analyses, and sample size calculation. We describe our planned statistical analyses for primary and secondary outcomes as well as pre-specified subgroup analyses. We also provide details for presenting results, including mock tables for baseline characteristics, adherence to the protocol and effect on clinical outcomes. According to best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and beginning analyses. We anticipate that this document will prevent analysis bias and enhance the utility of the reported results. ClinicalTrials.gov number, NCT01374022.

  13. Randomized controlled trials in dentistry: common pitfalls and how to avoid them.

    Science.gov (United States)

    Fleming, Padhraig S; Lynch, Christopher D; Pandis, Nikolaos

    2014-08-01

    Clinical trials are used to appraise the effectiveness of clinical interventions throughout medicine and dentistry. Randomized controlled trials (RCTs) are established as the optimal primary design and are published with increasing frequency within the biomedical sciences, including dentistry. This review outlines common pitfalls associated with the conduct of randomized controlled trials in dentistry. Common failings in RCT design leading to various types of bias including selection, performance, detection and attrition bias are discussed in this review. Moreover, methods of minimizing and eliminating bias are presented to ensure that maximal benefit is derived from RCTs within dentistry. Well-designed RCTs have both upstream and downstream uses acting as a template for development and populating systematic reviews to permit more precise estimates of treatment efficacy and effectiveness. However, there is increasing awareness of waste in clinical research, whereby resource-intensive studies fail to provide a commensurate level of scientific evidence. Waste may stem either from inappropriate design or from inadequate reporting of RCTs; the importance of robust conduct of RCTs within dentistry is clear. Optimal reporting of randomized controlled trials within dentistry is necessary to ensure that trials are reliable and valid. Common shortcomings leading to important forms or bias are discussed and approaches to minimizing these issues are outlined. Copyright © 2014 Elsevier Ltd. All rights reserved.

  14. Lessons Learned from EVOLVE for Planning of Future Randomized Trials in Patients on Dialysis.

    Science.gov (United States)

    Parfrey, Patrick S; Block, Geoffrey A; Correa-Rotter, Ricardo; Drüeke, Tilman B; Floege, Jürgen; Herzog, Charles A; London, Gerard M; Mahaffey, Kenneth W; Moe, Sharon M; Wheeler, David C; Chertow, Glenn M

    2016-03-07

    The effect of the calcimimetic cinacalcet on cardiovascular disease in patients undergoing hemodialysis with secondary hyperparathyroidism was assessed in the Evaluation of Cinacalcet Hydrochloride Therapy to Lower Cardiovascular Events trial. This was the largest (in size) and longest (in duration) randomized controlled clinical trial undertaken in this population. During planning, execution, analysis, and reporting of the trial, many lessons were learned, including those related to the use of a composite cardiovascular primary endpoint, definition of endpoints (particularly heart failure and severe unremitting hyperparathyroidism), importance of age for optimal stratification at randomization, use of unadjusted and adjusted intention-to-treat analysis for the primary outcome, how to respond to a lower-than-predicted event rate during the trial, development of a prespecified analytic plan that accounted for nonadherence and for cointerventions that diminished the power of the trial to observe a treatment effect, determination of the credibility of a subgroup effect, use of adverse effects database to investigate rare diseases, collection of blood for biomarker measurement not designated before trial initiation, and interpretation of the benefits-to-harms ratio for individual patients. It is likely that many of these issues will arise in the planning of future trials in CKD. Copyright © 2016 by the American Society of Nephrology.

  15. Audio-recorded information to patients considering participation in cancer clinical trials - a randomized study.

    Science.gov (United States)

    Bergenmar, Mia; Johansson, Hemming; Wilking, Nils; Hatschek, Thomas; Brandberg, Yvonne

    2014-09-01

    Patient information in cancer clinical trial is challenging. The value of audio-recording interventions for patients considering participating in clinical trials is unclear. The primary aim of this randomized study was to investigate effects of audio-recorded information on knowledge and understanding in patients considering participation in a clinical trial. Patients scheduled for information about a phases 2 or 3 trial by one of the 13 participating oncologists at the Department of Oncology during the study period (2008-2013) were eligible. The intervention consisted of an audio-recording on compact disc (CD) of the information at the medical consultation in which the patients were informed about a trial. Knowledge and understanding was measured by the questionnaire, Quality of Informed Consent. A total of 130 patients were randomized, 70% of the calculated sample size (n = 186). Sixty-seven patients were randomized to the intervention. In total, 101 patients (78%) completed questionnaires. No statistical significant differences were found between the groups with respect to knowledge and understanding. The level of knowledge was relatively high, with the exceptions of the risks associated with, and the unproven nature of, the trial. Overall, patients who declined participation scored statistically significant lower on knowledge. The present study was underpowered and the results should therefore be interpreted with caution. Still, 130 patients were included with a response rate of 78%. A CD including the oral information about a clinical trial did not show any effects on knowledge or understanding. However, the levels of knowledge were high, possible due to the high levels of education in the study group. Information on risks associated with the trial is still an area for improvement.

  16. Encouraging GPs to undertake screening and a brief intervention in order to reduce problem drinking: a randomized controlled trial

    DEFF Research Database (Denmark)

    Hansen, Lars Jørgen; Olivarius, Niels de Fine; Beich, Anders

    1999-01-01

    intervention, problem drinking, randomized controlled trial, family practice, marketing of health services......intervention, problem drinking, randomized controlled trial, family practice, marketing of health services...

  17. Oxytocin and autism: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Preti, Antonio; Melis, Mariangela; Siddi, Sara; Vellante, Marcello; Doneddu, Giuseppe; Fadda, Roberta

    2014-03-01

    Little is known about the effectiveness of pharmacological interventions on autism spectrum disorder (ASD). This is a systematic review of the randomized controlled trials (RCTs) of oxytocin interventions in autism, made from January 1990 to September 2013. A search of computerized databases was supplemented by manual search in the bibliographies of key publications. The methodological quality of the studies included in the review was evaluated independently by two researchers, according to a set of formal criteria. Discrepancies in scoring were resolved through discussion. The review yielded seven RCTs, including 101 subjects with ASD (males=95) and 8 males with Fragile X syndrome. The main categories of target symptoms tested in the studies were repetitive behaviors, eye gaze, and emotion recognition. The studies had a medium to high risk of bias. Most studies had small samples (median=15). All the studies but one reported statistically significant between-group differences on at least one outcome variable. Most findings were characterized by medium effect size. Only one study had evidence that the improvement in emotion recognition was maintained after 6 weeks of treatment with intranasal oxytocin. Overall, oxytocin was well tolerated and side effects, when present, were generally rated as mild; however, restlessness, increased irritability, and increased energy occurred more often under oxytocin. RCTs of oxytocin interventions in autism yielded potentially promising findings in measures of emotion recognition and eye gaze, which are impaired early in the course of the ASD condition and might disrupt social skills learning in developing children. There is a need for larger, more methodologically rigorous RCTs in this area. Future studies should be better powered to estimate outcomes with medium to low effect size, and should try to enroll female participants, who were rarely considered in previous studies. Risk of bias should be minimized. Human long

  18. Systematic review and meta-analysis of randomized trials on probiotics for hepatic encephalopathy

    DEFF Research Database (Denmark)

    Holte, Kathrine; Krag, Aleksander; Gluud, Lise Lotte

    2012-01-01

    Aim:  The objective of this systematic review and meta-analysis was to assess the efficacy of probiotics and synbiotics in patients with hepatic encephalopathy. Methods:  Eligible trials were identified by searching electronic databases including MEDLINE, the Cochrane Library, Science Citation...... Index and Embase, abstract proceedings, reference lists and ongoing trial registers until 13 October 2010. We included randomized controlled trials comparing probiotics and synbiotics with no intervention, placebo or lactulose in patients with hepatic encephalopathy. The primary outcome measure...... was improvement in hepatic encephalopathy. Results were expressed as risk rates (RR) with confidence intervals (CI) and intertrial heterogeneity as I(2) . Results:  Seven trials with a total of 393 patients were analyzed. Compared to placebo or lactulose, treatment with probiotics or synbiotics significantly...

  19. Effects of a Psychological Intervention in a Primary Health Care Center for Caregivers of Dependent Relatives: A Randomized Trial

    Science.gov (United States)

    Rodriguez-Sanchez, Emiliano; Patino-Alonso, Maria C.; Mora-Simon, Sara; Gomez-Marcos, Manuel A.; Perez-Penaranda, Anibal; Losada-Baltar, Andres; Garcia-Ortiz, Luis

    2013-01-01

    Purpose: To assess, in the context of Primary Health Care (PHC), the effect of a psychological intervention in mental health among caregivers (CGs) of dependent relatives. Design and Methods: Randomized multicenter, controlled clinical trial. The 125 CGs included in the trial were receiving health care in PHC. Inclusion criteria: Identifying…

  20. Outcomes in registered, ongoing randomized controlled trials of patient education.

    Directory of Open Access Journals (Sweden)

    Cécile Pino

    Full Text Available BACKGROUND: With the increasing prevalence of chronic noncommunicable diseases, patient education is becoming important to strengthen disease prevention and control. We aimed to systematically determine the extent to which registered, ongoing randomized controlled trials (RCTs evaluated an educational intervention focus on patient-important outcomes (i.e., outcomes measuring patient health status and quality of life. METHODS: On May 6, 2009, we searched for all ongoing RCTs registered in the World Health Organization International Clinical Trials Registry platform. We used a standardized data extraction form to collect data and determined whether the outcomes assessed were 1 patient-important outcomes such as clinical events, functional status, pain, or quality of life or 2 surrogate outcomes, such as biological outcome, treatment adherence, or patient knowledge. PRINCIPAL FINDINGS: We selected 268 of the 642 potentially eligible studies and assessed a random sample of 150. Patient-important outcomes represented 54% (178 of 333 of all primary outcomes and 46% (286 of 623 of all secondary outcomes. Overall, 69% of trials (104 of 150 used at least one patient-important outcome as a primary outcome and 66% (99 of 150 as a secondary outcome. Finally, for 31% of trials (46 of 150, primary outcomes were only surrogate outcomes. The results varied by medical area. In neuropsychiatric disorders, patient important outcomes represented 84% (51 of 61 of primary outcomes, as compared with 54% (32 of 59 in malignant neoplasm and 18% (4 of 22 in diabetes mellitus trials. In addition, only 35% assessed the long-term impact of interventions (i.e., >6 months. CONCLUSIONS: There is a need to improve the relevance of outcomes and to assess the long term impact of educational interventions in RCTs.

  1. Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial

    Science.gov (United States)

    2010-01-01

    Introduction To elucidate in polymyalgia rheumatica (PMR) the role of tumor necrosis factor (TNF) α and the therapeutic potential of blockade with soluble TNF-α receptor, we carried out the first randomized controlled trial with etanercept in PMR. Methods Twenty newly diagnosed, glucocorticoid (GC) naïve patients with PMR and 20 matched non-PMR control subjects completed the trial. Subjects were randomized in a 1:1 ratio to monotherapy with etanercept (25 mg s.c. biweekly) or placebo (saline) for 14 days. Study outcomes were assessed at baseline and after 14 days. The primary outcome was the change in PMR activity score (PMR-AS). Secondary outcomes were: changes in erythrocyte sedimentation rate (ESR) and plasma levels of TNF-α and interleukin (IL) 6; patients' functional status (health assessment questionnaire) and cumulative tramadol intake during the trial. Results At baseline, plasma TNF-α was higher in patients than in controls (P etanercept treatment (P etanercept decreased PMR-AS by 24% (P = 0.011), reflecting significant improvements in shoulder mobility, physician's global assessment and C-reactive protein, and insignificant (P > 0.05) improvements in duration of morning stiffness and patient's assessment of pain. In parallel, ESR and IL-6 were reduced (P 0.05). Functional status did not change and tramadol intake did not differ between patient groups. In controls, no changes occurred in both groups. Conclusions Etanercept monotherapy ameliorates disease activity in GC naïve patients with PMR. However, the effect is modest, indicating a minor role of TNF-α in PMR. Trial registration ClinicalTrials.gov (NCT00524381). PMID:20854662

  2. A quality assessment of randomized controlled trial reports in endodontics.

    Science.gov (United States)

    Lucena, C; Souza, E M; Voinea, G C; Pulgar, R; Valderrama, M J; De-Deus, G

    2017-03-01

    To assess the quality of the randomized clinical trial (RCT) reports published in Endodontics between 1997 and 2012. Retrieval of RCTs in Endodontics was based on a search of the Thomson Reuters Web of Science (WoS) database (March 2013). Quality evaluation was performed using a checklist based on the Jadad criteria, CONSORT (Consolidated Standards of Reporting Trials) statement and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials). Descriptive statistics were used for frequency distribution of data. Student's t-test and Welch test were used to identify the influence of certain trial characteristics upon report quality (α = 0.05). A total of 89 RCTs were evaluated, and several methodological flaws were found: only 45% had random sequence generation at low risk of bias, 75% did not provide information on allocation concealment, and 19% were nonblinded designs. Regarding statistics, only 55% of the RCTs performed adequate sample size estimations, only 16% presented confidence intervals, and 25% did not provide the exact P-value. Also, 2% of the articles used no statistical tests, and in 87% of the RCTs, the information provided was insufficient to determine whether the statistical methodology applied was appropriate or not. Significantly higher scores were observed for multicentre trials (P = 0.023), RCTs signed by more than 5 authors (P = 0.03), articles belonging to journals ranked above the JCR median (P = 0.03), and articles complying with the CONSORT guidelines (P = 0.000). The quality of RCT reports in key areas for internal validity of the study was poor. Several measures, such as compliance with the CONSORT guidelines, are important in order to raise the quality of RCTs in Endodontics. © 2016 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  3. Lysergic acid diethylamide (LSD) for alcoholism: meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Krebs, Teri S; Johansen, Pål-Ørjan

    2012-07-01

    Assessments of lysergic acid diethylamide (LSD) in the treatment of alcoholism have not been based on quantitative meta-analysis. Hence, we performed a meta-analysis of randomized controlled trials in order to evaluate the clinical efficacy of LSD in the treatment of alcoholism. Two reviewers independently extracted the data, pooling the effects using odds ratios (ORs) by a generic inverse variance, random effects model. We identified six eligible trials, including 536 participants. There was evidence for a beneficial effect of LSD on alcohol misuse (OR, 1.96; 95% CI, 1.36-2.84; p = 0.0003). Between-trial heterogeneity for the treatment effects was negligible (I² = 0%). Secondary outcomes, risk of bias and limitations are discussed. A single dose of LSD, in the context of various alcoholism treatment programs, is associated with a decrease in alcohol misuse.

  4. Laparoscopic ileocolic resection versus infliximab treatment of distal ileitis in Crohn's disease: a randomized multicenter trial (LIR!C-trial

    Directory of Open Access Journals (Sweden)

    van Heukelem Henk A

    2008-08-01

    Full Text Available Abstract Background With the availability of infliximab, nowadays recurrent Crohn's disease, defined as disease refractory to immunomodulatory agents that has been treated with steroids, is generally treated with infliximab. Infliximab is an effective but expensive treatment and once started it is unclear when therapy can be discontinued. Surgical resection has been the golden standard in recurrent Crohn's disease. Laparoscopic ileocolic resection proved to be safe and is characterized by a quick symptom reduction. The objective of this study is to compare infliximab treatment with laparoscopic ileocolic resection in patients with recurrent Crohn's disease of the distal ileum with respect to quality of life and costs. Methods/design The study is designed as a multicenter randomized clinical trial including patients with Crohn's disease located in the terminal ileum that require infliximab treatment following recent consensus statements on inflammatory bowel disease treatment: moderate to severe disease activity in patients that fail to respond to steroid therapy or immunomodulatory therapy. Patients will be randomized to receive either infliximab or undergo a laparoscopic ileocolic resection. Primary outcomes are quality of life and costs. Secondary outcomes are hospital stay, early and late morbidity, sick leave and surgical recurrence. In order to detect an effect size of 0.5 on the Inflammatory Bowel Disease Questionnaire at a 5% two sided significance level with a power of 80%, a sample size of 65 patients per treatment group can be calculated. An economic evaluation will be performed by assessing the marginal direct medical, non-medical and time costs and the costs per Quality Adjusted Life Year (QALY will be calculated. For both treatment strategies a cost-utility ratio will be calculated. Patients will be included from December 2007. Discussion The LIR!C-trial is a randomized multicenter trial that will provide evidence whether infliximab

  5. Laparoscopic ileocolic resection versus infliximab treatment of distal ileitis in Crohn's disease: a randomized multicenter trial (LIR!C-trial)

    Science.gov (United States)

    Eshuis, Emma J; Bemelman, Willem A; van Bodegraven, Ad A; Sprangers, Mirjam AG; Bossuyt, Patrick MM; de Wit, AW Marc van Milligen; Crolla, Rogier MPH; Cahen, Djuna L; Oostenbrug, Liekele E; Sosef, Meindert N; Voorburg, Annet MCJ; Davids, Paul HP; van der Woude, C Janneke; Lange, Johan; Mallant, Rosalie C; Boom, Maarten J; Lieverse, Rob J; van der Zaag, Edwin S; Houben, Martin HMG; Vecht, Juda; Pierik, Robert EGJM; van Ditzhuijsen, Theo JM; Prins, Hubert A; Marsman, Willem A; Stockmann, Henricus B; Brink, Menno A; Consten, Esther CJ; van der Werf, Sjoerd DJ; Marinelli, Andreas WKS; Jansen, Jeroen M; Gerhards, Michael F; Bolwerk, Clemens JM; Stassen, Laurents PS; Spanier, BW Marcel; Bilgen, Ernst Jan Spillenaar; van Berkel, Anne-Marie; Cense, Huib A; van Heukelem, Henk A; van de Laar, Arnold; Slot, Warner Bruins; Eijsbouts, Quirijn A; van Ooteghem, Nancy AM; van Wagensveld, Bart; van den Brande, Jan MH; van Geloven, Anna AW; Bruin, Karien F; Maring, John K; Oldenburg, Bas; van Hillegersberg, Richard; de Jong, Dirk J; Bleichrodt, Robert; van der Peet, Donald L; Dekkers, Pascal EP; Goei, T Hauwy; Stokkers, Pieter CF

    2008-01-01

    Background With the availability of infliximab, nowadays recurrent Crohn's disease, defined as disease refractory to immunomodulatory agents that has been treated with steroids, is generally treated with infliximab. Infliximab is an effective but expensive treatment and once started it is unclear when therapy can be discontinued. Surgical resection has been the golden standard in recurrent Crohn's disease. Laparoscopic ileocolic resection proved to be safe and is characterized by a quick symptom reduction. The objective of this study is to compare infliximab treatment with laparoscopic ileocolic resection in patients with recurrent Crohn's disease of the distal ileum with respect to quality of life and costs. Methods/design The study is designed as a multicenter randomized clinical trial including patients with Crohn's disease located in the terminal ileum that require infliximab treatment following recent consensus statements on inflammatory bowel disease treatment: moderate to severe disease activity in patients that fail to respond to steroid therapy or immunomodulatory therapy. Patients will be randomized to receive either infliximab or undergo a laparoscopic ileocolic resection. Primary outcomes are quality of life and costs. Secondary outcomes are hospital stay, early and late morbidity, sick leave and surgical recurrence. In order to detect an effect size of 0.5 on the Inflammatory Bowel Disease Questionnaire at a 5% two sided significance level with a power of 80%, a sample size of 65 patients per treatment group can be calculated. An economic evaluation will be performed by assessing the marginal direct medical, non-medical and time costs and the costs per Quality Adjusted Life Year (QALY) will be calculated. For both treatment strategies a cost-utility ratio will be calculated. Patients will be included from December 2007. Discussion The LIR!C-trial is a randomized multicenter trial that will provide evidence whether infliximab treatment or surgery is the

  6. Effects of auriculotherapy on labour pain: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Reginaldo Roque Mafetoni

    Full Text Available Abstract OBJECTIVE Assessing the effects of auriculotherapy in pain control and its outcomes on the duration of labour. METHOD This is a randomized, controlled, double-blind trial with preliminary data. Thirty pregnant women with gestational age ≥ 37 weeks, cervical dilatation ≥ 4 cm and two or more contractions in 10 minutes were selected and randomly divided into three groups: auriculotherapy, placebo and control. Auriculotherapy was applied using crystal beads on four strategic points. RESULTS No statistical significance was found between the groups with regard to pain; however, the women from the auriculotherapy group had lower intensity and less perception of pain at 30, 60 and 120 minutes of treatment. The average duration of labour was shorter in the auriculotherapy group (248.7 versus placebo 414.8 versus control 296.3 minutes; caesarean section rates were higher in the placebo group (50% and the same in the other groups (10%. CONCLUSION Mothers who received auriculotherapy presented a tendency for greater pain control and shorter labour duration; however, caesarean section rates in this group were similar to the control group. This trial precedes a larger study in progress. Registration of Brazilian Clinical Trials: RBR-47hhbj.

  7. Randomized Clinical Trial of Interceptive and Comprehensive Orthodontics

    Science.gov (United States)

    King, G.J.; Spiekerman, C.F.; Greenlee, G.M.; Huang, G.J.

    2012-01-01

    Focusing public insurance programs on interceptive orthodontics (IO) may increase access for low-income children. This report presents outcomes from a randomized clinical trial (RCT) comparing IO with comprehensive orthodontics (CO) in Medicaid patients. One hundred seventy pre-adolescents with Medicaid-eligible malocclusions were randomized to IO (n = 86) followed by observation (OBS) or OBS followed by CO (n = 84). One hundred thirty-four completed the trial. Models at pre-treatment (baseline) and following ≤ 2 years of intervention and 2 years of OBS (48 mos) were scored by calibrated examiners using the Peer Assessment Rating (PAR) and Index of Complexity, Outcome and Need (ICON). Overall outcomes and clinically meaningful categorical ICON data on need/acceptability, complexity, and improvement were compared. At baseline, groups were balanced by age, gender, ethnicity, and PAR/ICON scores. Most were minorities. Most (77%) were rated as difficult-to-very difficult. Scores improved significantly for both groups, but CO more than IO (PAR, 18.6 [95%CI 15.1, 22.1] vs.10.1 [95%CI 6.7, 13.4]; ICON, 44.8 [95% CI 39.7, 49.9] vs. 35.2 [95%CI 29.7, 40.6], respectively). On average, IO is effective at reducing malocclusions in Medicaid patients, but less than CO. (ClinicalTrials.gov number CT00067379) PMID:22699670

  8. Randomized trial of tapas acupressure technique for weight loss maintenance

    Directory of Open Access Journals (Sweden)

    Elder Charles R

    2012-03-01

    Full Text Available Abstract Background Obesity is an urgent public health problem, yet only a few clinical trials have systematically tested the efficacy of long-term weight-loss maintenance interventions. This randomized clinical trial tested the efficacy of a novel mind and body technique for weight-loss maintenance. Methods Participants were obese adults who had completed a six-month behavioral weight-loss program prior to randomization. Those who successfully lost weight were randomized into either an experimental weight-loss maintenance intervention, Tapas Acupressure Technique (TAT®, or a control intervention comprised of social-support group meetings (SS led by professional facilitators. TAT combines self-applied light pressure to specific acupressure points accompanied by a prescribed sequence of mental steps. Participants in both maintenance conditions attended eight group sessions over six months of active weight loss maintenance intervention, followed by an additional 6 months of no intervention. The main outcome measure was change in weight from the beginning of the weight loss maintenance intervention to 12 months later. Secondary outcomes were change in depression, stress, insomnia, and quality of life. We used analysis of covariance as the primary analysis method. Missing values were replaced using multiple imputation. Results Among 285 randomized participants, 79% were female, mean age was 56 (standard deviation (sd = 11, mean BMI at randomization was 34 (sd = 5, and mean initial weight loss was 9.8 kg (sd = 5. In the primary outcome model, there was no significant difference in weight regain between the two arms (1.72 kg (se 0.85 weight regain for TAT and 2.96 kg (se 0.96 weight regain for SS, p post hoc tests showing that greater initial weight loss was associated with more weight regain for SS but less weight regain for TAT. Conclusions The primary analysis showed no significant difference in weight regain between TAT and SS, while secondary

  9. Echinacea for treating the common cold: a randomized trial.

    Science.gov (United States)

    Barrett, Bruce; Brown, Roger; Rakel, Dave; Mundt, Marlon; Bone, Kerry; Barlow, Shari; Ewers, Tola

    2010-12-21

    Echinacea is widely used to treat the common cold. To assess the potential benefits of echinacea as a treatment of common cold. Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00065715) Dane County, Wisconsin. 719 patients, aged 12 to 80 years, with new-onset common cold. Patients were assigned to 1 of 4 parallel groups: no pills, placebo pills (blinded), echinacea pills (blinded), or echinacea pills (unblinded, open-label). Echinacea groups received the equivalent of 10.2 g of dried echinacea root during the first 24 hours and 5.1 g during each of the next 4 days. Indistinguishable placebo tablets contained only inert ingredients. The primary outcome was the area under the curve for global severity, with severity assessed twice daily by self-report using the Wisconsin Upper Respiratory Symptom Survey, short version. Secondary outcomes included interleukin-8 levels and neutrophil counts from nasal wash, assessed at intake and 2 days later. Of the 719 patients enrolled, 713 completed the protocol. Mean age was 33.7 years, 64% were female, and 88% were white. Mean global severity was 236 and 258 for the blinded and unblinded echinacea groups, respectively; 264 for the blinded placebo group; and 286 for the no-pill group. A comparison of the 2 blinded groups showed a 28-point trend (95% CI, -69 to 13 points) toward benefit for echinacea (P = 0.089). Mean illness duration in the blinded and unblinded echinacea groups was 6.34 and 6.76 days, respectively, compared with 6.87 days in the blinded placebo group and 7.03 days in the no-pill group. A comparison of the blinded groups showed a nonsignificant 0.53-day (CI, -1.25 to 0.19 days) benefit (P = 0.075). Median change in interleukin-8 levels and neutrophil counts were also not statistically significant (30 ng/L and 1 cell/high-power field [hpf] in the no-pill group, 39 ng/L and 1 cell/hpf in the blinded placebo group, 58 ng/L and 2 cells/hpf in the blinded echinacea group, and 70 ng/L and 1

  10. Randomized Clinical Trials on Acupuncture in Korean Literature: A Systematic Review

    Directory of Open Access Journals (Sweden)

    Jae Cheol Kong

    2009-01-01

    Full Text Available The aim of this systematic review was to summarize randomized clinical trials (RCTs assessing the effectiveness of acupuncture as published in Korean literature. Systematic searches were conducted on eight Korean medical databases. Manual searches were also conducted through eight major Korean medical journals. The methodological quality was assessed using a Jadad score. Studies evaluating needle acupuncture or auricular acupuncture (AA with or without electrical stimulation were considered if they were sham or placebo-controlled or controlled against a comparative intervention. We also excluded acupuncture as an adjuvant to other treatments and other forms of acupuncture were excluded. Seven hundred and nine possibly relevant studies were identified and 10 RCTs were included. The methodological quality of the trials was generally poor. Manual acupuncture was compared to placebo acupuncture in four studies of patients with chronic low back pain, shoulder pain, premenstrual syndrome and allergic rhinitis. Three studies tested AA (two trials and electroacupuncture (one trial against no treatment, while three trials compared acupuncture with other active therapeutic controls. The methodological limitations of the included trials make their contribution to the current clinical evidence of acupuncture somewhat limited. The trial for premenstrual syndrome, shoulder pain and chronic low back pain added a limited contribution among those included RCTs. However, well-designed RCTs of acupuncture with a rigorous methodology are in progress or have been completed in Korea and will contribute to establish or contribute to the current progress of research in this field.

  11. A better alternative to stratified permuted block design for subject randomization in clinical trials.

    Science.gov (United States)

    Zhao, Wenle

    2014-12-30

    Stratified permuted block randomization has been the dominant covariate-adaptive randomization procedure in clinical trials for several decades. Its high probability of deterministic assignment and low capacity of covariate balancing have been well recognized. The popularity of this sub-optimal method is largely due to its simplicity in implementation and the lack of better alternatives. Proposed in this paper is a two-stage covariate-adaptive randomization procedure that uses the block urn design or the big stick design in stage one to restrict the treatment imbalance within each covariate stratum, and uses the biased-coin minimization method in stage two to control imbalances in the distribution of additional covariates that are not included in the stratification algorithm. Analytical and simulation results show that the new randomization procedure significantly reduces the probability of deterministic assignments, and improve the covariate balancing capacity when compared to the traditional stratified permuted block randomization. Copyright © 2014 John Wiley & Sons, Ltd.

  12. Recruitment barriers in a randomized controlled trial from the physicians' perspective – A postal survey

    Directory of Open Access Journals (Sweden)

    Karrer Werner

    2009-03-01

    Full Text Available Abstract Background The feasibility of randomized trials often depends on successful patient recruitment. Although numerous recruitment barriers have been identified it is unclear which of them complicate recruitment most. Also, most surveys have focused on the patients' perspective of recruitment barriers whereas the perspective of recruiting physicians has received less attention. Therefore, our aim was to conduct a postal survey among recruiting physicians of a multi-center trial to weigh barriers according to their impact on recruitment. Methods We identified any potential recruitment barriers from the literature and from our own experience with a multi-center trial of respiratory rehabilitation in patients with chronic obstructive pulmonary disease. We developed and pilot-tested a self-administered questionnaire where recruiting physicians were asked to express their agreement with statements about recruitment barriers on a Likert-type scale from 1 (full agreement with statement = very substantial recruitment barrier to 7 (no agreement with statement = no recruitment barrier. Results 38 of 55 recruiting physicians returned questionnaires (69% response rate, of which 35 could be analyzed (64% useable response rate. Recruiting physicians reported that "time constraints" (median agreement of 3, interquartile range 2–5 had the most negative impact on recruitment followed by "difficulties including identified eligible patients" (median agreement of 5, IQR 3–6. Other barriers such as "trial design barriers", "lack of access to treatment", "individual barriers of recruiting physicians" or "insufficient training of recruiting physicians" were perceived to have little or no impact on patient recruitment. Conclusion Physicians perceived time constraints as the most relevant recruitment barrier in a randomized trial. To overcome recruitment barriers interventions, that are affordable for both industry- and investigator-driven trials, need to be

  13. Dietary Fiber Supplementation for Fecal Incontinence: A Randomized Clinical Trial

    Science.gov (United States)

    Bliss, Donna Z.; Savik, Kay; Jung, Hans-Joachim G.; Whitebird, Robin; Lowry, Ann; Sheng, Xioayan

    2014-01-01

    Dietary fiber supplements are used to manage fecal incontinence (FI), but little is known about the fiber type to recommend or the level of effectiveness of such supplements, which appear related to the fermentability of the fiber. The aim of this single-blind, randomized controlled trial was to compare the effects of three dietary fiber supplements (carboxymethylcellulose [CMC], gum arabic [GA], or psyllium) with differing levels of fermentability to a placebo in community-living individuals incontinent of loose/liquid feces. The primary outcome was FI frequency; secondary outcomes included FI amount and consistency, supplement intolerance, and quality of life (QoL). Possible mechanisms underlying supplement effects were also examined. After a 14-day baseline, 189 subjects consumed a placebo or 16g total fiber/day of one of the fiber supplements for 32 days. FI frequency significantly decreased after psyllium supplementation versus placebo, in both intent-to-treat and per-protocol mixed model analyses. CMC increased FI frequency. In intent-to-treat analysis, the number of FI episodes/week after supplementation was estimated to be 5.5 for Placebo, 2.5 for Psyllium, 4.3 for GA, and 6.2 for CMC. Only psyllium consumption resulted in a gel in feces. Supplement intolerance was low. QoL scores did not differ among groups. Patients with FI may experience a reduction in FI frequency after psyllium supplementation, and decreased FI frequency has been shown to be an important personal goal of treatment for patients with FI. Formation of a gel in feces appears to be a mechanism by which residual psyllium improved FI. PMID:25155992

  14. Dietary fiber supplementation for fecal incontinence: a randomized clinical trial.

    Science.gov (United States)

    Bliss, Donna Z; Savik, Kay; Jung, Hans-Joachim G; Whitebird, Robin; Lowry, Ann; Sheng, Xiaoyan

    2014-10-01

    Dietary fiber supplements are used to manage fecal incontinence (FI), but little is known about the fiber type to recommend or the level of effectiveness of such supplements, which appears related to the fermentability of the fiber. The aim of this single-blind, randomized controlled trial was to compare the effects of three dietary fiber supplements (carboxymethylcellulose [CMC], gum arabic [GA], or psyllium) with differing levels of fermentability to a placebo in community-living individuals incontinent of loose/liquid feces. The primary outcome was FI frequency; secondary outcomes included FI amount and consistency, supplement intolerance, and quality of life (QoL). Possible mechanisms underlying supplement effects were also examined. After a 14-day baseline, 189 subjects consumed a placebo or 16 g total fiber/day of one of the fiber supplements for 32 days. FI frequency significantly decreased after psyllium supplementation versus placebo, in both intent-to-treat and per-protocol mixed model analyses. CMC increased FI frequency. In intent-to-treat analysis, the number of FI episodes/week after supplementation was estimated to be 5.5 for Placebo, 2.5 for Psyllium, 4.3 for GA, and 6.2 for CMC. Only psyllium consumption resulted in a gel in feces. Supplement intolerance was low. QoL scores did not differ among groups. Patients with FI may experience a reduction in FI frequency after psyllium supplementation, and decreased FI frequency has been shown to be an important personal goal of treatment for patients with FI. Formation of a gel in feces appears to be a mechanism by which residual psyllium improved FI. © 2014 Wiley Periodicals, Inc.

  15. Identifying randomized clinical trials in Spanish-language dermatology journals.

    Science.gov (United States)

    Sanclemente, G; Pardo, H; Sánchez, S; Bonfill, X

    2015-06-01

    The necessary foundation for good clinical practice lies in knowledge derived from clinical research. Evidence from randomized clinical trials (RCTs) is the pillar on which decisions about therapy are based. To search exhaustively and rigorously to identify RCTs in dermatology journals published in Spanish. We located dermatology journals through the following search engines and indexes: PubMed, LILACS, SciELO, Periódica, Latindex, Índice Médico Español, C-17, IBECS, EMBASE, and IMBIOMED. We also sought information through dermatology associations and dermatologists in countries where Spanish was the usual language of publication, and we searched the Internet (Google). Afterwards we searched the journals electronically and manually to identify RCTs in all available volumes and issues, checking from the year publication started through 2012. Of 28 journals identified, we included 21 in the search. We found a total of 144 RCTs published since 1969; 78 (54%) were in Latin American journals and 66 (46%) were in Spanish journals. The most frequent disease contexts for RCTs in Spanish journals were psoriasis, mycoses, and acne vulgaris. In Latin American journals, the most frequent disease contexts were common warts, mycoses, acne vulgaris, and skin ulcers on the lower limbs. Manual searches identified more RCTs than electronic searches. Manual searches found a larger number of RCTs. Relatively fewer RCTs are published in Spanish and Latin American journals than in English-language journals. Internet facilitated access to full texts published by many journals; however, free open access to these texts is still unavailable and a large number of journal issues are still not posted online. Copyright © 2014 Elsevier España, S.L.U. and AEDV. All rights reserved.

  16. Randomized Trials in Developing Countries: Different Priorities and Study Design?

    Science.gov (United States)

    Marin, Benoît; Agbota, Gino Cédric; Preux, Pierre-Marie; Boumédiene, Farid

    2016-01-01

    Clinical trials are increasingly conducted in the field of neurology in developing countries. To our knowledge, no review has been performed to date about the temporal evolution, geographical distribution, pathological fields, and types of trials conducted. Besides, the validity of those clinical trials needs to be evaluated. Our main aim was to describe, using a systematic literature review, the clinical trials performed in the field of neurology in developing countries. The specific objectives were (1) to describe the pathologic fields, (2) to evaluate the methodology, and (3) to assess the validity of neurological clinical trials performed in developing countries. A systematic review of the literature was conducted accessing PubMed, Pascal, ScienceDirect, African Journal Online, and the Virtual Library of African Neurology. The 145 studies included allowed us to identify (1) an exponential evolution of the number of clinical trials, (2) the strong contributions from Asia, followed by Africa and Latin America, (3) a fairly good coverage of pathologic fields including noncommunicable diseases, (4) an increasing diversity of intervention type, (5) the lack of early-phase trials (phases I and IIa), and (5) the need of improvement for some critical methodological issues. There is a need (1) to develop structures dedicated to the early investigation of interventions in humans, and (2) for sustaining the development of structures specialized in the methodology of clinical research and of dedicated courses for researchers in tropical areas about good practice in clinical trials. This would help in improving methodological quality, appropriateness of data management, and statistical analysis. © 2016 S. Karger AG, Basel.

  17. Aerobic exercise and vascular cognitive impairment: A randomized controlled trial.

    Science.gov (United States)

    Liu-Ambrose, Teresa; Best, John R; Davis, Jennifer C; Eng, Janice J; Lee, Philip E; Jacova, Claudia; Boyd, Lara A; Brasher, Penelope M; Munkacsy, Michelle; Cheung, Winnie; Hsiung, Ging-Yuek R

    2016-11-15

    To assess the efficacy of a progressive aerobic exercise training program on cognitive and everyday function among adults with mild subcortical ischemic vascular cognitive impairment (SIVCI). This was a proof-of-concept single-blind randomized controlled trial comparing a 6-month, thrice-weekly, progressive aerobic exercise training program (AT) with usual care plus education on cognitive and everyday function with a follow-up assessment 6 months after the formal cessation of aerobic exercise training. Primary outcomes assessed were general cognitive function (Alzheimer's Disease Assessment Scale-Cognitive subscale [ADAS-Cog]), executive functions (Executive Interview [EXIT-25]), and activities of daily living (Alzheimer's Disease Cooperative Study-Activities of Daily Living [ADCS-ADL]). Seventy adults randomized to aerobic exercise training or usual care were included in intention-to-treat analyses (mean age 74 years, 51% female, n = 35 per group). At the end of the intervention, the aerobic exercise training group had significantly improved ADAS-Cog performance compared with the usual care plus education group (-1.71 point difference, 95% confidence interval [CI] -3.15 to -0.26, p = 0.02); however, this difference was not significant at the 6-month follow-up (-0.63 point difference, 95% CI -2.34 to 1.07, p = 0.46). There were no significant between-group differences at intervention completion and at the 6-month follow-up in EXIT-25 or ADCS-ADL performance. Examination of secondary measures showed between-group differences at intervention completion favoring the AT group in 6-minute walk distance (30.35 meter difference, 95% CI 5.82 to 54.86, p = 0.02) and in diastolic blood pressure (-6.89 mm Hg difference, 95% CI -12.52 to -1.26, p = 0.02). This study provides preliminary evidence for the efficacy of 6 months of thrice-weekly progressive aerobic training in community-dwelling adults with mild SIVCI, relative to usual care plus education. NCT01027858. This study

  18. Risk moderation of a parent and student preventive alcohol intervention by adolescent and family factors: A cluster randomized trial

    NARCIS (Netherlands)

    Verdurmen, J.E.E.; Koning, I.M.; Vollebergh, W.A.M.; Eijnden, R.J.J.M. van den; Engels, R.C.M.E.

    2014-01-01

    Objective: To examine risk moderation of an alcohol intervention targeting parents and adolescents. Design: A cluster randomized trial including 2937 Dutch early adolescents (m = 12.68 years, SD = 0.51) and their parents randomized over four conditions: parent intervention, student intervention,

  19. Risk moderation of a parent and student preventive alcohol intervention by adolescent and family factors : A cluster randomized trial

    NARCIS (Netherlands)

    Verdurmen, Jacqueline E E; Koning, Ina M.|info:eu-repo/dai/nl/304822329; Vollebergh, Wilma A M|info:eu-repo/dai/nl/090632893; van den Eijnden, Regina J J M|info:eu-repo/dai/nl/17399394X; Engels, Rutger C M E

    2014-01-01

    Objective: To examine risk moderation of an alcohol intervention targeting parents and adolescents. Design: A cluster randomized trial including 2937 Dutch early adolescents (m=12.68. years, SD=0.51) and their parents randomized over four conditions: parent intervention, student intervention,

  20. Randomized Trial of MST and ARC in a Two-Level Evidence-Based Treatment Implementation Strategy

    Science.gov (United States)

    Glisson, Charles; Schoenwald, Sonja K.; Hemmelgarn, Anthony; Green, Philip; Dukes, Denzel; Armstrong, Kevin S.; Chapman, Jason E.

    2010-01-01

    Objective: A randomized trial assessed the effectiveness of a 2-level strategy for implementing evidence-based mental health treatments for delinquent youth. Method: A 2 x 2 design encompassing 14 rural Appalachian counties included 2 factors: (a) the random assignment of delinquent youth within each county to a multisystemic therapy (MST) program…

  1. Many randomized trials of physical therapy interventions are not adequately registered: a survey of 200 published trials.

    Science.gov (United States)

    Pinto, Rafael Zambelli; Elkins, Mark R; Moseley, Anne M; Sherrington, Catherine; Herbert, Robert D; Maher, Christopher G; Ferreira, Paulo H; Ferreira, Manuela L

    2013-03-01

    Clinical trial registration has several putative benefits: prevention of selective reporting, avoidance of duplication, encouragement of participation, and facilitation of reviews. Previous surveys suggest that most trials are registered. However, these surveys examined only trials in journals with high impact factors, which may bias the results. This study examined the completeness of clinical trial registration and the extent of selective reporting of outcomes in a random sample of published randomized trials in physical therapy. This was a retrospective cohort study in which 200 randomized trials of physical therapy interventions were randomly selected from those published in 2009 and indexed in the Physiotherapy Evidence Database (PEDro), regardless of the publishing journal. Evidence of registration was sought for each trial in the study, on clinical trial registers, and by contacting authors. The proportion of randomized trials that were registered was 67/200 (34%). This proportion was significantly lower than among the trials in journals with high impact factors, where the proportion was 75% (odds ratio=7.4, 95% confidence interval=2.6-21.4). Unambiguous primary outcomes (ie, method and time points of measurement clearly defined in the trial registry entry) were registered for 32 trials, and registration was adequate (ie, prospective with unambiguous primary outcomes) for 5/200 (2.5%) trials. Selective outcome reporting occurred in 23 (47%) of the 49 trials in which selective reporting was assessable. The inclusion of only English-language trials prevents generalization of the results to non-English-language trials. Registration of randomized trials of physical therapy interventions is rarely adequate. Consequently, the putative benefits of registration are not being fully realized.

  2. Montelukast for Postinfectious Cough: A Systematic Review of Randomized Controlled Trials.

    Science.gov (United States)

    Dong, S; Zhong, Y; Lu, W; Jaing, H; Mao, B

    2015-05-13

    To systematically assess the efficacy and safety of montelukast for postinfectious cough (PIC) and to propose a recommendation via a systematic review of all available randomized controlled trials (RCTs). Electronic databases and relevant journals were searched for RCTs from inception to July 2014. In addition, some unpublished literature was also searched. All studies included in the systematic review met the same inclusion criteria. Methodological quality and evidence quality were examined according to Cochrane handbook. The data were extracted and trial quality was assessed independently by two reviewers. Fourteen RCTs involving 1372 patients were included in our review. The methodological quality of the included trials was poor because one or more biases were observed in these studies. The quality of evidence was low to moderate levels. All trials reported better effect favouring montelukast treatment. Findings suggested that compared with other Western medication and Chinese medicine, montelukast showed significant effects in shortening cough relief time, increasing the clinic obvious effective rate, decreasing coughing frequency and severity, and improving quality of life. Adverse events were mentioned in six studies, but no serious adverse effects were reported in any of them. Montelukast demonstrated potential positive efficacy and safety for PIC; however, we could not come to a firm conclusion on the efficacy and safety of montelukast for PIC. More high quality randomized controlled trials are required to confirm the efficacy and safety of montelukast for PIC.

  3. A Randomized Controlled Trial of Mindfulness Meditation for Chronic Insomnia

    Science.gov (United States)

    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 MBSR were sustained from post-treatment through follow-up, with MBTI showing the highest rates of treatment remission (50%) and response (78.6%) at the 6-month follow-up. Conclusions: Mindfulness meditation appears to be a viable treatment option for adults with chronic 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

  4. Determining optimal sample sizes for multi-stage randomized clinical trials using value of information methods.

    Science.gov (United States)

    Willan, Andrew; Kowgier, Matthew

    2008-01-01

    Traditional sample size calculations for randomized clinical trials depend on somewhat arbitrarily chosen factors, such as Type I and II errors. An effectiveness trial (otherwise known as a pragmatic trial or management trial) is essentially an effort to inform decision-making, i.e., should treatment be adopted over standard? Taking a societal perspective and using Bayesian decision theory, Willan and Pinto (Stat. Med. 2005; 24:1791-1806 and Stat. Med. 2006; 25:720) show how to determine the sample size that maximizes the expected net gain, i.e., the difference between the cost of doing the trial and the value of the information gained from the results. These methods are extended to include multi-stage adaptive designs, with a solution given for a two-stage design. The methods are applied to two examples. As demonstrated by the two examples, substantial increases in the expected net gain (ENG) can be realized by using multi-stage adaptive designs based on expected value of information methods. In addition, the expected sample size and total cost may be reduced. Exact solutions have been provided for the two-stage design. Solutions for higher-order designs may prove to be prohibitively complex and approximate solutions may be required. The use of multi-stage adaptive designs for randomized clinical trials based on expected value of sample information methods leads to substantial gains in the ENG and reductions in the expected sample size and total cost.

  5. Steroid hormones for contraception in men: systematic review of randomized controlled trials.

    Science.gov (United States)

    Grimes, David A; Gallo, Maria F; Grigorieva, Vera; Nanda, Kavita; Schulz, Kenneth F

    2005-02-01

    Male hormonal contraception has been an elusive goal. Administration of sex steroids to men can shut off sperm production through effects on the pituitary and hypothalamus. However, this approach also decreases production of testosterone, so an "add-back" therapy is needed. We conducted a systematic review of all randomized controlled trials of male hormonal contraception and azoospermia. Few significant differences emerged from these trials. Levonorgestrel implants combined with injectable testosterone enanthate (100 mg im) were significantly more effective than was levonorgestrel 125 microg po daily combined with testosterone patches [10 mg/d; odds ratio (OR) for azoospermia with the oral levonorgestrel regimen, 0.03; 95% CI, 0.00-0.29]. The addition of levonorgestrel 500 microg po daily improved the effectiveness of testosterone enanthate 100 mg im weekly by itself (OR for azoospermia with the combined regimen, 4.0; 95% CI, 1.00-15.99). Several regimens, including testosterone alone and gonadotropin-releasing hormone agonists and antagonists, had disappointing results. In conclusion, no male hormonal contraceptive is ready for clinical use. All trials published to date have been small exploratory studies. As a result, their power to detect important differences has been limited and their results have been imprecise. In addition, the definition of oligospermia has been imprecise or inconsistent in many reports. To avoid bias, future trials need to pay more attention on the methodological requirements for randomized controlled trials. Trials with adequate power would also be helpful.

  6. Randomized trial of an electronic asthma monitoring system among New York City children.

    Science.gov (United States)

    Jacobson, Judith S; Lieblein, Andrea; Fierman, Arthur H; Fishkin, Edward R; Hutchinson, Vincent E; Rodriguez, Luis; Serebrisky, Denise; Chau, Michelle; Saperstein, Arnold

    2009-11-01

    To test the efficacy of an electronic asthma monitoring system (AMS) to reduce pediatric emergency department (ED) visits and hospitalizations for asthma. Randomized clinical trial. Families of pediatric patients with asthma aged 8 to 17 years were recruited at 6 medical centers. Children were randomly assigned to the American Medical Alert Corporation pediatric AMS or a paper diary. The numbers of and costs associated with ED visits and hospitalizations for the 2 groups in the year following randomization were compared using t tests of statistical significance. Of 59 children recruited to the trial, 29 were randomized to the AMS and 30 to the diary. The 2 groups were similar in demographic and clinical characteristics. During their study year, 24 AMS group members logged on a mean (SD) of 211.0 (117.3) days; 13 diary group members provided data on a mean (SD) of 136.6 (128.0) days. During the 32 months that the study was in progress, the case managers logged on a mean (SD) of 171.0 (97.2) days. Overall, 35 children had at least 1 ED visit, but only 7 children were hospitalized. The 2 groups had no statistically significant differences in the numbers of or charges associated with ED visits or hospitalizations. Electronic devices are being developed to make chronic disease management easier for patients and their families, but they should not be adopted without careful study, including randomized trials, to ascertain their use, costs, and benefits.

  7. Traditional Chinese Medicine for Treatment of Fibromyalgia: A Systematic Review of Randomized Controlled Trials

    Science.gov (United States)

    Cao, Huijuan; Lewith, George T.

    2010-01-01

    Abstract Background Traditional Chinese Medicine (TCM) is popular for treatment of fibromyalgia (FM) although there is a lack of comprehensive evaluation of current clinical evidence for TCM's therapeutic effect and safety. Objective To review systematically the beneficial and harmful effects of TCM therapies for FM. Methods We searched six English and Chinese electronic databases for randomized clinical trials (RCTs) on TCM for treatment of FM. Two authors extracted data and assessed the trial quality independently. RevMan 5 software was used for data analyses with an effect estimate presented as mean difference (MD) with a 95% confidence interval (CI). Results Twenty-five RCTs were identified with 1516 participants for this review. Seven trials (28%) were evaluated as having a low risk of bias and the remaining trials were identified as being as unclear or having a high risk of bias. Overall, ten trials were eligible for the meta-analysis, and data from remaining 15 trials were synthesized qualitatively. Acupuncture reduced the number of tender points (MD, –3.21; 95% CI –4.23 to –2.11; p effect, with a random-effect model, compared with sham acupuncture (MD, –0.55; 95% CI, –1.35–0.24; p = 0.17; I2 = 69%), on pain reduction. A combination of acupuncture and cupping therapy was better than conventional medications for reducing pain (MD, –1.66; 95% CI, –2.14 to –1.19; p effects of Chinese herbal medicine on pain reduction compared with conventional medications. There were no serious adverse effects reported that were related to TCM therapies in these trials. Conclusions TCM therapies appear to be effective for treating FM. However, further large, rigorously designed trials are warranted because of insufficient methodological rigor in the included trials. PMID:20423209

  8. Representation and reporting of kidney disease in cerebrovascular disease: A systematic review of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Ioannis Konstantinidis

    Full Text Available Patients with kidney disease (KD are at increased risk for cerebrovascular disease (CVD and CVD patients with KD have worse outcomes. We aimed to determine the representation of KD patients in major randomized controlled trials (RCTs of CVD interventions. We searched MEDLINE for reports of major CVD trials published through February 9, 2017. We excluded trials that did not report mortality outcomes, enrolled fewer than 100 participants, or were subgroup, follow-up, or post-hoc analyses. Two independent reviewers performed study selection and data extraction. We included 135 RCTs randomizing 194,977 participants. KD patients were excluded in 48 (35.6% trials, but were less likely to be excluded from trials of class I/II recommended interventions (n = 7; 15.9%; p = 0.001 and more likely to be excluded in trials with registered protocols (45.5% vs. 22.4%; p = 0.007. Exclusion was lower in trials supported by academic or governmental grants compared to industry or combined funding (21.2% vs. 42.0% and 47.8%; p = 0.033 and 0.028, respectively. Among trials excluding KD patients, 24 (50.0% used serum creatinine, 7 (14.6% used estimated glomerular filtration rate or creatinine clearance, 7 (14.6% used renal replacement therapy, and 19 (39.6% used non-specific kidney-related criteria. Only 4 (3.0% trials reported baseline renal function. No trials prespecified or reported subgroup analyses by baseline renal function. Although 19 (14.1% trials reported the incidence of acute kidney injury, no trial examined adverse event rates according to renal function. In summary, more than one third of major CVD trials excluded patients with KD, primarily based on serum creatinine or non-specific criteria, and outcomes were not stratified by renal parameters. Therefore, purposeful efforts to increase inclusion of KD patients in CVD trials and evaluate the impact of renal function on efficacy and safety are needed to improve the quality of evidence for interventions

  9. Sponsorship, antidepressant dose, and outcome in major depressive disorder: meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Sinyor, Mark; Schaffer, Ayal; Smart, Kelly A; Levitt, Anthony J; Lanctôt, Krista L; Grysman, Noam H

    2012-02-01

    Differences in dosing may influence results of pharmaceutical industry-sponsored medication trials. This study aims to determine the relationship between sponsorship and antidepressant dosing and efficacy in randomized controlled trials for major depressive disorder. Trials were identified through English-language searches of MEDLINE and PsycINFO (January 1996-June 2010) using specific drug names and classes and depressive disorder or major depression and double blind or double-blind method. Other limitations included human subjects and treatment study designs using the clinical queries option. Other sources were also searched following a strict set of inclusion and exclusion criteria. Randomized controlled trials were included if they examined antidepressant treatment for major depressive disorder, reported mean final medication dosages, acknowledged an association with industry, and included study arms of medications produced by the associated manufacturer and a competitor ("sponsor" and "nonsponsor" arms) (58 trials involving 15,026 patients from 101 citations identified). Data on dosing, efficacy, baseline severity, and adverse events were extracted by 2 of the authors. Meta-analyses were used to examine dosing and efficacy data. Using consensus guidelines for medication dosing, we determined that sponsor medication was dosed relatively higher than nonsponsor medication, in 37% (22/60) of comparisons as opposed to 5% (3/60) in which the nonsponsor medication was dosed higher (χ²₂ = 25.9, P events. Sponsor drugs are dosed higher than nonsponsor drugs in antidepressant randomized controlled trials, and higher dosing is associated with better sponsor drug outcomes in some cases. © Copyright 2012 Physicians Postgraduate Press, Inc.

  10. Acupuncture for recurrent headaches: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Melchart, D; Linde, K; Fischer, P; White, A; Allais, G; Vickers, A; Berman, B

    1999-11-01

    To assess whether there is evidence that acupuncture is effective in the treatment of recurrent headaches. Systematic review. Randomized or quasi-randomized clinical trials comparing acupuncture with any type of control intervention for the treatment of recurrent headaches. Electronic databases (Medline, Embase, Cochrane Field for Complementary Medicine, Cochrane Controlled Trials Register), personal communications and bibliographies. Information on patients, interventions, methods, and results were extracted by at least two independent reviewers using a pretested form. A pooled estimate of the responder rate ratio (responder rate in treatment group/responder rate in control group) was calculated as a crude indicator of trial results as meta-analysis of more specific outcome data was impossible due to heterogeneity and insufficient reporting. Twenty-two trials, including a total of 1042 patients (median 36, range 10-150), met the inclusion criteria. Fifteen trials were in migraine patients, six in tension-headache patients, and in one trial patients with various headaches were included. The majority of the 14 trials comparing true and sham acupuncture showed at least a trend in favor of true acupuncture. The pooled responder rate ratio was 1.53 (95% confidence interval 1.11 to 2.11). The eight trials comparing acupuncture and other treatment forms had contradictory results. Overall, the existing evidence suggests that acupuncture has a role in the treatment of recurrent headaches. However, the quality and amount of evidence is not fully convincing. There is urgent need for well-planned, large-scale studies to assess effectiveness and efficiency of acupuncture under real life conditions.

  11. Difficulties in recruitment for a randomized controlled trial involving hysterosalpingography

    Directory of Open Access Journals (Sweden)

    Helmerhorst Frans M

    2006-06-01

    Full Text Available Abstract Background The usefulness of hysterosalpingography (HSG as routine investigation in the fertility work-up prior to laparoscopy and dye had been assessed in a randomized controlled trial. Recruiting subjects to the study was more difficult than anticipated. The objective of this study was to explore possible reasons for non-participation in the trial. Methods All newly referred subfertile women admitted to the Reproductive Medicine Clinic of Leiden University Medical Centre between 1 April 1997 and 31 December 1999, were eligible for the study. The reasons for non-participation were evaluated by scrutinizing the medical records. Results Out of 759 women, a total of 127 (17% agreed to participate in the trial. The most important reason for non-participation was because of exclusion criteria (73%. Other reasons were inattentive clinicians (3% and patient-associated reasons (24%. Patient refusal and indecisiveness to enroll in the study were the most common patient-associated reasons. The most frequently stated reason for trial refusal was reluctance to undergo laparoscopy and dye mainly due to issues related to anesthesia and scheduling of procedure. Conclusion Almost three-quarters of recruitment difficulties in this study were due to unavoidable reasons. To overcome the remaining avoidable reasons for non-participation, attention should be paid to appropriate instruction of the study protocol to the participating doctors and to provide adequate information, in layman's terms, to the patients. Reminding patients by notes or telephone calls for attending the clinic are helpful. It may be contingent upon tracing the reasons of clinicians and patients for non-participation to improve enrollment during a trial.

  12. Global Postural Reeducation for patients with musculoskeletal conditions: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Ferreira, Giovanni E; Barreto, Rodrigo G P; Robinson, Caroline C; Plentz, Rodrigo D M; Silva, Marcelo F

    2016-04-01

    To systematically review randomized controlled trials that assessed the effects of Global Postural Reeducation (GPR) on patient-reported outcomes in conditions of the musculoskeletal system. An electronic search of MEDLINE (via PubMed), EMBASE, Cochrane CENTRAL, and SciELO was performed from their inception to June 2015. Randomized controlled trials that analyzed pain and patient-reported outcomes were included in this review. The Cochrane Collaboration's Risk of Bias Tool was used to evaluate risk of bias, and the quality of evidence was rated following the GRADE approach. There were no language restrictions. Eleven trials were included totaling 383 patients. Overall, the trials had high risk of bias. GPR was superior to no treatment but not to other forms of treatment for pain and disability. No placebo-controlled trials were found. GPR is not superior to other treatments; however, it is superior to no treatment. Due to the lack of studies, it is unknown if GPR is better than placebo. The quality of the available evidence ranges from low to very low, therefore future studies may change the effect estimates of GPR in musculoskeletal conditions.

  13. Global Postural Reeducation for patients with musculoskeletal conditions: a systematic review of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Giovanni E. Ferreira

    2016-01-01

    Full Text Available ABSTRACT Objectives To systematically review randomized controlled trials that assessed the effects of Global Postural Reeducation (GPR on patient-reported outcomes in conditions of the musculoskeletal system. Method An electronic search of MEDLINE (via PubMed, EMBASE, Cochrane CENTRAL, and SciELO was performed from their inception to June 2015. Randomized controlled trials that analyzed pain and patient-reported outcomes were included in this review. The Cochrane Collaboration’s Risk of Bias Tool was used to evaluate risk of bias, and the quality of evidence was rated following the GRADE approach. There were no language restrictions. Results Eleven trials were included totaling 383 patients. Overall, the trials had high risk of bias. GPR was superior to no treatment but not to other forms of treatment for pain and disability. No placebo-controlled trials were found. Conclusion GPR is not superior to other treatments; however, it is superior to no treatment. Due to the lack of studies, it is unknown if GPR is better than placebo. The quality of the available evidence ranges from low to very low, therefore future studies may change the effect estimates of GPR in musculoskeletal conditions.

  14. The Ethics of Randomized Controlled Trials in Social Settings: Can Social Trials Be Scientifically Promising and Must There Be Equipoise?

    Science.gov (United States)

    Fives, Allyn; Russell, Daniel W.; Canavan, John; Lyons, Rena; Eaton, Patricia; Devaney, Carmel; Kearns, Norean; O'Brien, Aoife

    2015-01-01

    In a randomized controlled trial (RCT), treatments are assigned randomly and treatments are withheld from participants. Is it ethically permissible to conduct an RCT in a social setting? This paper addresses two conditions for justifying RCTs: that there should be a state of equipoise and that the trial should be scientifically promising.…

  15. Physical activity as an aid to smoking cessation during pregnancy (LEAP trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ussher Michael

    2012-10-01

    Full Text Available Abstract Background Many women try to stop smoking in pregnancy but fail. One difficulty is that there is insufficient evidence that medications for smoking cessation are effective and safe in pregnancy and thus many women prefer to avoid these. Physical activity (PA interventions may assist cessation; however, trials examining these interventions have been too small to detect or exclude plausible beneficial effects. The London Exercise And Pregnant smokers (LEAP trial is investigating whether a PA intervention is effective and cost-effective when used for smoking cessation by pregnant women, and will be the largest study of its kind to date. Methods/design The LEAP study is a pragmatic, multi-center, two-arm, randomized, controlled trial that will target pregnant women who smoke at least one cigarette a day (and at least five cigarettes a day before pregnancy, and are between 10 and 24 weeks pregnant. Eligible patients are individually randomized to either usual care (that is, behavioral support for smoking cessation or usual care plus a intervention (entailing supervised exercise on a treadmill plus PA consultations. The primary outcome of the trial is self-reported and biochemically validated continuous abstinence from smoking between a specified quit date and the end of pregnancy. The secondary outcomes, measured at 1 and 4 weeks after the quit date, and at the end of pregnancy and 6 months after childbirth, are PA levels, depression, self-confidence, and cigarette withdrawal symptoms. Smoking status will also be self-reported at 6 months after childbirth. In addition, perinatal measures will be collected, including antenatal complications, duration of labor, mode of delivery, and birth and placental weight. Outcomes will be analyzed on an intention-to-treat basis, and logistic regression models used to compare treatment effects on the primary outcome. Discussion This trial will assess whether a PA intervention is effective when used for

  16. Special features of health services and register based trials – experiences from a randomized trial of childbirth classes

    Directory of Open Access Journals (Sweden)

    Sevón Tiina

    2008-06-01

    Full Text Available Abstract Background Evaluating complex interventions in health services faces various difficulties, such as making practice changes and costs. Ways to increase research capacity and decrease costs include making research an integral part of health services and using routine data to judge outcomes. The purpose of this article is to report the feasibility of a pilot trial relying solely on routinely collected register data and being based on ordinary health services. Methods The example intervention was education to public health nurses (PHN (childbirth classes to reduce caesarean section rates via pre-delivery considerations of pregnant women. 20 maternity health centers (MHC were paired and of each 10 pairs, one MHC was randomly allocated to an intervention group and the other to a control; 8 pairs with successful intervention were used in the analyses (1601 mothers. The women visiting to the study maternity centers were identified from the Customer Register of Helsinki City. A list of the study women was made using the mother's personal identification number, visit date, the maternity center code, birth date and gestation length. The mode of delivery and health outcomes were retrieved from the Finnish Medical Birth Register (MBR. Process data of the intervention are based on observations, written feedback and questionnaires from PHNs, and project correspondence. Results It took almost two years to establish how to obtain permissions and to actually obtain it for the trial. Obtaining permissions for the customer and outcome data and register linkages was unproblematic and the cluster randomization provided comparable groups. The intervention did not succeed well. Had the main aim of the trial been to cause a change in PHNs behavior, we would have very likely intensified the intervention during the trial. Conclusion Our experiences encourage the use of trials that obtain their outcomes from registers. Changing the behavior of ordinary health

  17. Empirical Evidence of Study Design Biases in Randomized Trials: Systematic Review of Meta-Epidemiological Studies.

    Science.gov (United States)

    Page, Matthew J; Higgins, Julian P T; Clayton, Gemma; Sterne, Jonathan A C; Hróbjartsson, Asbjørn; Savović, Jelena

    2016-01-01

    To synthesise evidence on the average bias and heterogeneity associated with reported methodological features of randomized trials. Systematic review of meta-epidemiological studies. We retrieved eligible studies included in a recent AHRQ-EPC review on this topic (latest search September 2012), and searched Ovid MEDLINE and Ovid EMBASE for studies indexed from Jan 2012-May 2015. Data were extracted by one author and verified by another. We combined estimates of average bias (e.g. ratio of odds ratios (ROR) or difference in standardised mean differences (dSMD)) in meta-analyses using the random-effects model. Analyses were stratified by type of outcome ("mortality" versus "other objective" versus "subjective"). Direction of effect was standardised so that ROR studies. The available evidence suggests that intervention effect estimates may be exaggerated in trials with inadequate/unclear (versus adequate) sequence generation (ROR 0.93, 95% CI 0.86 to 0.99; 7 studies) and allocation concealment (ROR 0.90, 95% CI 0.84 to 0.97; 7 studies). For these characteristics, the average bias appeared to be larger in trials of subjective outcomes compared with other objective outcomes. Also, intervention effects for subjective outcomes appear to be exaggerated in trials with lack of/unclear blinding of participants (versus blinding) (dSMD -0.37, 95% CI -0.77 to 0.04; 2 studies), lack of/unclear blinding of outcome assessors (ROR 0.64, 95% CI 0.43 to 0.96; 1 study) and lack of/unclear double blinding (ROR 0.77, 95% CI 0.61 to 0.93; 1 study). The influence of other characteristics (e.g. unblinded trial personnel, attrition) is unclear. Certain characteristics of randomized trials may exaggerate intervention effect estimates. The average bias appears to be greatest in trials of subjective outcomes. More research on several characteristics, particularly attrition and selective reporting, is needed.

  18. Porcine collagen matrix for treating gingival recession. Randomized clinical trial.

    Directory of Open Access Journals (Sweden)

    Yuri Castro

    2014-03-01

    Full Text Available Achieving root coverage after exposure caused by gingival recession is one of the main goals of reconstructive periodontal surgery. Even though a large variety of techniques and mucogingival grafting procedures are available, their long-term results are not clear yet. Therefore, this study aimed to compare clinical effectiveness of the porcine collagen matrix with subepithelial connective graft for treating Miller class I and II gingival recessions. Materials and methods: The randomized clinical trial included twelve patients assigned to two groups. In the first group (experimental, six patients were treated using collagen matrix (mean age, 54.3±5.6 years; mean recession 2. 67±1.03mm. Another group (control of six patients was treated using connective grafts (mean age, 57.1± 2.7 years; mean recession 4.33±1.03mm. All patients underwent periodontal evaluation and pre-surgical preparation including oral hygiene instruction and supragingival scaling. Gingival recessions were exposed through partial thickness flaps where the grafts and matrices were placed. Patients were assessed periodically until complete healing of tissue. Results: Root coverage parameters, amount of keratinized gingiva, gingival biotype and clinical attachment level were evaluated. The root coverage percentage for the group using connective graft was 24.7±13.5% and 16.6±26.8% for the one treated with the matrix. The amount of increased keratinized tissue was 4.33±2.06mm and 4.5±0.83mm for the control and experimental group respectively. Both groups increased gingival biotypes from thin to thick at 100%. The final clinical attachment level was 4.17±3.17±04mm for the control group and 0.98mm for the experimental group. There were significant differences between the outcome of gingival recession and clinical attachment. Conclusion: Results indicate both techniques, besides being predictable, are useful for improving clinical parameters when treating gingival recessions

  19. Exercise program for prevention of groin pain in football players: a cluster-randomized trial

    DEFF Research Database (Denmark)

    Hölmich, P; Larsen, K; Krogsgaard, Kim

    2010-01-01

    strengthening (concentric and eccentric), coordination, and core stability exercises for the muscles related to the pelvis. Physiotherapists assigned to each club registered all groin injuries. Twenty-two clubs in each group completed the study, represented by 977 players. There was no significant effect......Groin injuries cause major problems in sports and particularly in football. Exercise is effective in treating adductor-related groin pain, but no trials have been published regarding the specific prevention of groin pain or prevention specifically targeting overuse injuries in sport using exercise...... programs. We performed a cluster-randomized trial including 55 football clubs representing 1211 players. The clubs were randomized to an exercise program aimed at preventing groin injuries (n=27) or to a control group training as usual (n=28). The intervention program consisted of six exercises including...

  20. Exercise program for prevention of groin pain in football players: a cluster-randomized trial

    DEFF Research Database (Denmark)

    Hölmich, P; Larsen, K; Krogsgaard, Kim

    2010-01-01

    Groin injuries cause major problems in sports and particularly in football. Exercise is effective in treating adductor-related groin pain, but no trials have been published regarding the specific prevention of groin pain or prevention specifically targeting overuse injuries in sport using exercise...... programs. We performed a cluster-randomized trial including 55 football clubs representing 1211 players. The clubs were randomized to an exercise program aimed at preventing groin injuries (n=27) or to a control group training as usual (n=28). The intervention program consisted of six exercises including...... strengthening (concentric and eccentric), coordination, and core stability exercises for the muscles related to the pelvis. Physiotherapists assigned to each club registered all groin injuries. Twenty-two clubs in each group completed the study, represented by 977 players. There was no significant effect...

  1. Fluoride concentration from dental sealants: a randomized clinical trial.

    Science.gov (United States)

    Campus, G; Carta, G; Cagetti, M G; Bossù, M; Sale, S; Cocco, F; Conti, G; Nardone, M; Sanna, G; Strohmenger, L; Lingström, P

    2013-07-01

    A randomized clinical trial was performed in schoolchildren (6-7 yrs) to evaluate fluoride concentration in interproximal fluid after the placement of 3 different sealants. The sample consisted of 2,776 children randomly divided: 926 in the high-viscosity Glass-ionomer Cement group (GIC group), 923 in the fluoride Resin-based group (fluoride-RB group), and 927 in the no-fluoride Resin-based group (RB group). In total, 2,640 children completed the trial. Sealants were applied following manufacturer's instructions. Interproximal fluid samples were collected at baseline and 2, 7, and 21 days after application of sealants, by insertion of a standardized paperpoint into the interproximal mesial space of the sealed tooth for 15 seconds. Fluoride concentration was evaluated by means of a fluoride ion-selective electrode. At 2 days after sealant application, fluoride concentration was significantly higher in GIC and fluoride-RB groups compared with that in the RB group (p sealants increased the fluoride concentrations in interproximal fluid more than did a Resin-based sealant containing fluoride.

  2. Antenatal hypnosis training and childbirth experience: a randomized controlled trial.

    Science.gov (United States)

    Werner, Anette; Uldbjerg, Niels; Zachariae, Robert; Wu, Chun Sen; Nohr, Ellen A

    2013-12-01

    Childbirth is a demanding event in a woman's life. The aim of this study was to explore whether a brief intervention in the form of an antenatal course in self-hypnosis to ease childbirth could improve the childbirth experience. In a randomized, controlled, single-blinded trial, 1,222 healthy nulliparous women were allocated to one of three groups during pregnancy: A hypnosis group participating in three 1-hour sessions teaching self-hypnosis to ease childbirth, a relaxation group receiving three 1-hour lessons in various relaxation methods and Mindfulness, and a usual care group receiving ordinary antenatal care only. Wijmas Delivery Expectancy/Experience Questionnaire (W-DEQ) was used to measure the childbirth experience 6 weeks postpartum. The intention-to-treat analysis indicated that women in the hypnosis group experienced their childbirth as better compared with the other two groups (mean W-DEQ score of 42.9 in the Hypnosis group, 47.2 in the Relaxation group, and 47.5 in the Care as usual group (p = 0.01)). The tendency toward a better childbirth experience in the hypnosis group was also seen in subgroup analyses for mode of delivery and for levels of fear. In this large randomized controlled trial, a brief course in self-hypnosis improved the women's childbirth experience. © 2013, Copyright the Authors Journal compilation © 2013, Wiley Periodicals, Inc.

  3. A randomized trial of colchicine for acute pericarditis.

    Science.gov (United States)

    Imazio, Massimo; Brucato, Antonio; Cemin, Roberto; Ferrua, Stefania; Maggiolini, Stefano; Beqaraj, Federico; Demarie, Daniela; Forno, Davide; Ferro, Silvia; Maestroni, Silvia; Belli, Riccardo; Trinchero, Rita; Spodick, David H; Adler, Yehuda

    2013-10-17

    Colchicine is effective for the treatment of recurrent pericarditis. However, conclusive data are lacking regarding the use of colchicine during a first attack of acute pericarditis and in the prevention of recurrent symptoms. In a multicenter, double-blind trial, eligible adults with acute pericarditis were randomly assigned to receive either colchicine (at a dose of 0.5 mg twice daily for 3 months for patients weighing >70 kg or 0.5 mg once daily for patients weighing ≤70 kg) or placebo in addition to conventional antiinflammatory therapy with aspirin or ibuprofen. The primary study outcome was incessant or recurrent pericarditis. A total of 240 patients were enrolled, and 120 were randomly assigned to each of the two study groups. The primary outcome occurred in 20 patients (16.7%) in the colchicine group and 45 patients (37.5%) in the placebo group (relative risk reduction in the colchicine group, 0.56; 95% confidence interval, 0.30 to 0.72; number needed to treat, 4; Ppericarditis, colchicine, when added to conventional antiinflammatory therapy, significantly reduced the rate of incessant or recurrent pericarditis. (Funded by former Azienda Sanitaria Locale 3 of Turin [now Azienda Sanitaria Locale 2] and Acarpia; ICAP ClinicalTrials.gov number, NCT00128453.).

  4. Selective outcome reporting and sponsorship in randomized controlled trials in IVF and ICSI.

    Science.gov (United States)

    Braakhekke, M; Scholten, I; Mol, F; Limpens, J; Mol, B W; van der Veen, F

    2017-10-01

    Are randomized controlled trials (RCTs) on IVF and ICSI subject to selective outcome reporting and is this related to sponsorship? There are inconsistencies, independent from sponsorship, in the reporting of primary outcome measures in the majority of IVF and ICSI trials, indicating selective outcome reporting. RCTs are subject to bias at various levels. Of these biases, selective outcome reporting is particularly relevant to IVF and ICSI trials since there is a wide variety of outcome measures to choose from. An established cause of reporting bias is sponsorship. It is, at present, unknown whether RCTs in IVF/ICSI are subject to selective outcome reporting and whether this is related with sponsorship. We systematically searched RCTs on IVF and ICSI published between January 2009 and March 2016 in MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and the publisher subset of PubMed. We analysed 415 RCTs. Per included RCT, we extracted data on impact factor of the journal, sample size, power calculation, and trial registry and thereafter data on primary outcome measure, the direction of trial results and sponsorship. Of the 415 identified RCTs, 235 were excluded for our primary analysis, because the sponsorship was not reported. Of the 180 RCTs included in our analysis, 7 trials did not report on any primary outcome measure and 107 of the remaining 173 trials (62%) reported on surrogate primary outcome measures. Of the 114 registered trials, 21 trials (18%) provided primary outcomes in their manuscript that were different from those in the trial registry. This indicates selective outcome reporting. We found no association between selective outcome reporting and sponsorship. We ran additional analyses to include the trials that had not reported sponsorship and found no outcomes that differed from our primary analysis. Since the majority of the trials did not report on sponsorship, there is a risk on sampling bias. IVF and ICSI trials are subject, to

  5. Randomized clinical trials in dentistry: Risks of bias, risks of random errors, reporting quality, and methodologic quality over the years 1955-2013.

    Science.gov (United States)

    Saltaji, Humam; Armijo-Olivo, Susan; Cummings, Greta G; Amin, Maryam; Flores-Mir, Carlos

    2017-01-01

    To examine the risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions and the development of these aspects over time. We included 540 randomized clinical trials from 64 selected systematic reviews. We extracted, in duplicate, details from each of the selected randomized clinical trials with respect to publication and trial characteristics, reporting and methodologic characteristics, and Cochrane risk of bias domains. We analyzed data using logistic regression and Chi-square statistics. Sequence generation was assessed to be inadequate (at unclear or high risk of bias) in 68% (n = 367) of the trials, while allocation concealment was inadequate in the majority of trials (n = 464; 85.9%). Blinding of participants and blinding of the outcome assessment were judged to be inadequate in 28.5% (n = 154) and 40.5% (n = 219) of the trials, respectively. A sample size calculation before the initiation of the study was not performed/reported in 79.1% (n = 427) of the trials, while the sample size was assessed as adequate in only 17.6% (n = 95) of the trials. Two thirds of the trials were not described as double blinded (n = 358; 66.3%), while the method of blinding was appropriate in 53% (n = 286) of the trials. We identified a significant decrease over time (1955-2013) in the proportion of trials assessed as having inadequately addressed methodological quality items (P < 0.05) in 30 out of the 40 quality criteria, or as being inadequate (at high or unclear risk of bias) in five domains of the Cochrane risk of bias tool: sequence generation, allocation concealment, incomplete outcome data, other sources of bias, and overall risk of bias. The risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions have improved over time; however, further efforts that contribute to the development of more stringent

  6. Vitamin D supplementation and total mortality: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Autier, Philippe; Gandini, Sara

    2007-09-10

    Ecological and observational studies suggest that low vitamin D status could be associated with higher mortality from life-threatening conditions including cancer, cardiovascular disease, and diabetes mellitus that account for 60% to 70% of total mortality in high-income countries. We examined the risk of dying from any cause in subjects who participated in randomized trials testing the impact of vitamin D supplementation (ergocalciferol [vitamin D(2)] or cholecalciferol [vitamin D(3)]) on any health condition. The literature up to November 2006 was searched without language restriction using the following databases: PubMed, ISI Web of Science (Science Citation Index Expanded), EMBASE, and the Cochrane Library. We identified 18 independent randomized controlled trials, including 57 311 participants. A total of 4777 deaths from any cause occurred during a trial size-adjusted mean of 5.7 years. Daily doses of vitamin D supplements varied from 300 to 2000 IU. The trial size-adjusted mean daily vitamin D dose was 528 IU. In 9 trials, there was a 1.4- to 5.2-fold difference in serum 25-hydroxyvitamin D between the intervention and control groups. The summary relative risk for mortality from any cause was 0.93 (95% confidence interval, 0.87-0.99). There was neither indication for heterogeneity nor indication for publication biases. The summary relative risk did not change according to the addition of calcium supplements in the intervention. Intake of ordinary doses of vitamin D supplements seems to be associated with decreases in total mortality rates. The relationship between baseline vitamin D status, dose of vitamin D supplements, and total mortality rates remains to be investigated. Population-based, placebo-controlled randomized trials with total mortality as the main end point should be organized for confirming these findings.

  7. Hospital recruitment for a pragmatic cluster-randomized clinical trial: Lessons learned from the COMPASS study.

    Science.gov (United States)

    Johnson, Anna M; Jones, Sara B; Duncan, Pamela W; Bushnell, Cheryl D; Coleman, Sylvia W; Mettam, Laurie H; Kucharska-Newton, Anna M; Sissine, Mysha E; Rosamond, Wayne D

    2018-01-26

    Pragmatic randomized clinical trials are essential to determine the effectiveness of interventions in "real-world" clinical practice. These trials frequently use a cluster-randomized methodology, with randomization at the site level. Despite policymakers' increased interest in supporting pragmatic randomized clinical trials, no studies to date have reported on the unique recruitment challenges faced by cluster-randomized pragmatic trials. We investigated key challenges and successful strategies for hospital recruitment in the Comprehensive Post-Acute Stroke Services (COMPASS) study. The COMPASS study is designed to compare the effectiveness of the COMPASS model versus usual care in improving functional outcomes, reducing the numbers of hospital readmissions, and reducing caregiver strain for patients discharged home after stroke or transient ischemic attack. This model integrates early supported discharge planning with transitional care management, including nurse-led follow-up phone calls after 2, 30, and 60 days and an in-person clinic visit at 7-14 days involving a functional assessment and neurological examination. We present descriptive statistics of the characteristics of successfully recruited hospitals compared with all eligible hospitals, reasons for non-participation, and effective recruitment strategies. We successfully recruited 41 (43%) of 95 eligible North Carolina hospitals. Leading, non-exclusive reasons for non-participation included: insufficient staff or financial resources (n = 33, 61%), lack of health system support (n = 16, 30%), and lack of support of individual decision-makers (n = 11, 20%). Successful recruitment strategies included: building and nurturing relationships, engaging team members and community partners with a diverse skill mix, identifying gatekeepers, finding mutually beneficial solutions, having a central institutional review board, sharing published pilot data, and integrating contracts and review board

  8. Effect of the Mediterranean diet on blood pressure in the PREDIMED trial: results from a randomized controlled trial

    OpenAIRE

    Toledo, Estefanía; Hu, F. B.; Estruch Riba, Ramon; Buil-Cosiales, P.; Corella Piquer, Dolores; Salas Salvadó, Jordi; Covas Planells, María Isabel; Arós, Fernando; Gómez-Gracia, E.; Fiol Sala, Miguel; Lapetra, José; Serra Majem, Lluís; Pintó Sala, Xavier; Lamuela Raventós, Rosa Ma.; Sáez Tormo, Guillermo

    2013-01-01

    BACKGROUND: Hypertension can be prevented by adopting healthy dietary patterns. Our aim was to assess the 4-year effect on blood pressure (BP) control of a randomized feeding trial promoting the traditional Mediterranean dietary pattern. METHODS: The PREDIMED primary prevention trial is a randomized, single-blinded, controlled trial conducted in Spanish primary healthcare centers. We recruited 7,447 men (aged 55 to 80 years) and women (aged 60 to 80 years) who had high risk for car...

  9. Role of micronutrients in congestive heart failure: A systematic review of randomized controlled trials

    OpenAIRE

    Valiyakizha Kkeveetil, Chandini; Thomas, Grace; Chander, Sam Johnson Udaya

    2016-01-01

    Objectives: To assess the effect of micronutrients on health outcomes in patients with heart failure. Materials and Methods: Only randomized controlled trials testing the effectiveness of different micronutrients either singly or combined versus placebo in heart failure patients were included. We conducted a search in different databases such as Medline from PubMed, Embase and Scopus from Elsevier, and Google Scholar. The keywords used in the search were ?Heart Failure? and its cognates, ?Mic...

  10. Acupuncture and moxibustion for lateral elbow pain: A systematic review of randomized controlled trials

    OpenAIRE

    Yeung, Wingfai; Chung, Kafai; Wang, Fuchun; Zhang, Shiping; Bangrazi, Sergio; Bian, Zhaoxiang; Gadau, Marcus; Liu, Hua; Zaslawski, Chris J.; Tan, Yuansheng

    2014-01-01

    Background: Acupuncture and moxibustion have widely been used to treat lateral elbow pain (LEP). A comprehensive systematic review of randomized controlled trials (RCTs) including both English and Chinese databases was conducted to assess the efficacy of acupuncture and moxibustion in the treatment of LEP.Methods: Revised STRICTA (2010) criteria were used to appraise the acupuncture procedures, the Cochrane risk of bias tool was used to assess the methodological quality of the studies. A tota...

  11. Mapping randomized controlled trials of treatments for eczema - The GREAT database (The Global Resource of Eczema Trials: a collection of key data on randomized controlled trials of treatments for eczema from 2000 to 2010

    Directory of Open Access Journals (Sweden)

    Williams Hywel C

    2011-05-01

    Full Text Available Abstract Background Massive duplication of effort occurs when researchers all over the world undertake extensive searches for randomized controlled trials when preparing systematic reviews, when developing evidence-based guidelines and when applying for research funding for eczema treatments. Such duplication wastes valuable resources. Searching for randomized controlled trials of eczema is a laborious task involving scrutiny of thousands of individual references from diverse electronic databases in order to obtain a few papers of interest. Clinicians and patients who wish to find out more about a particular treatment are at risk of missing the relevant evidence if they are not trained in electronic bibliographic searching. Systematic reviews cannot be relied upon to comprehensively inform current optimal eczema treatments due to incomplete coverage and because many may be out of date. An international, publically available and comprehensive resource which brings together all randomized controlled trials on eczema treatment using a highly sensitive search has the potential to release more filtered knowledge about patient care to those who need it most and to significantly shorten the duration and costs of many clinical eczema research and guideline projects. Description The Global Resource of EczemA Trials brings together information on all randomized controlled trials of eczema treatments published from the beginning of 2000 up to the end of 2010 and will be updated every month. We searched the Cochrane Central Register of Controlled Trials in The Cochrane Library and the Cochrane Skin Group Specialised Register, MEDLINE, EMBASE, LILACS, AMED and CINHAL databases. We included 268 RCTs (24th March 2011 covering over 70 different treatment interventions. The structure of the Global Resource of Eczema Trials allows the user as much, or as little, specificity when retrieving information on trials as they wish, in an easy to use format. For each

  12. Exercise Training and Weight Gain in Obese Pregnant Women: A Randomized Controlled Trial (ETIP Trial.

    Directory of Open Access Journals (Sweden)

    Kirsti Krohn Garnæs

    2016-07-01

    .04. Systolic blood pressure was significantly lower in the exercise group (mean 120.4 mm Hg compared to the control group (mean 128.1 mm Hg, with a mean difference of -7.73 mm Hg (95% CI -13.23, -2.22; p = 0.006. No significant between-group differences were seen in diastolic blood pressure, blood measurements, skinfold thickness, or body composition in late pregnancy. In per protocol analyses, late pregnancy systolic blood pressure was 115.7 (95% CI 110.0, 121.5 mm Hg in the exercise group (significant between-group difference, p = 0.001, and diastolic blood pressure was 75.1 (95% CI 71.6, 78.7 mm Hg (significant between-group difference, p = 0.02. We had planned to recruit 150 women into the trial; hence, under-recruitment represents a major limitation of our results. Another limitation to our study was the low adherence to the exercise program, with only 50% of the women included in the intention-to-treat analysis adhering as described in the study protocol.In this trial we did not observe a reduction in GWG among overweight/obese women who received a supervised exercise training program during their pregnancy. The incidence of GDM in late pregnancy seemed to be lower in the women randomized to exercise training than in the women receiving standard maternity care only. Systolic blood pressure in late pregnancy was also apparently lower in the exercise group than in the control group. These results indicate that supervised exercise training might be beneficial as a part of standard pregnancy care for overweight/obese women.ClinicalTrials.gov NCT01243554.

  13. Exercise Training and Weight Gain in Obese Pregnant Women: A Randomized Controlled Trial (ETIP Trial).

    Science.gov (United States)

    Garnæs, Kirsti Krohn; Mørkved, Siv; Salvesen, Øyvind; Moholdt, Trine

    2016-07-01

    .04). Systolic blood pressure was significantly lower in the exercise group (mean 120.4 mm Hg) compared to the control group (mean 128.1 mm Hg), with a mean difference of -7.73 mm Hg (95% CI -13.23, -2.22; p = 0.006). No significant between-group differences were seen in diastolic blood pressure, blood measurements, skinfold thickness, or body composition in late pregnancy. In per protocol analyses, late pregnancy systolic blood pressure was 115.7 (95% CI 110.0, 121.5) mm Hg in the exercise group (significant between-group difference, p = 0.001), and diastolic blood pressure was 75.1 (95% CI 71.6, 78.7) mm Hg (significant between-group difference, p = 0.02). We had planned to recruit 150 women into the trial; hence, under-recruitment represents a major limitation of our results. Another limitation to our study was the low adherence to the exercise program, with only 50% of the women included in the intention-to-treat analysis adhering as described in the study protocol. In this trial we did not observe a reduction in GWG among overweight/obese women who received a supervised exercise training program during their pregnancy. The incidence of GDM in late pregnancy seemed to be lower in the women randomized to exercise training than in the women receiving standard maternity care only. Systolic blood pressure in late pregnancy was also apparently lower in the exercise group than in the control group. These results indicate that supervised exercise training might be beneficial as a part of standard pregnancy care for overweight/obese women. ClinicalTrials.gov NCT01243554.

  14. Randomized clinical trial comparing an oral carbohydrate beverage with placebo before laparoscopic cholecystectomy

    DEFF Research Database (Denmark)

    Bisgaard, T; Kristiansen, V B; Hjortsø, N C

    2004-01-01

    evaluated the clinical effects of a preoperative carbohydrate beverage in patients undergoing laparoscopic cholecystectomy. METHODS: Ninety-four patients undergoing laparoscopic cholecystectomy were included in a randomized clinical trial. Patients were randomized to receive 800 ml of an iso-osmolar 12.......5 per cent carbohydrate-rich beverage the evening before operation (100 g carbohydrate) and another 400 ml (50 g carbohydrate) 2 h before initiation of anaesthesia, or the same volume of a placebo beverage. The primary endpoint was general well-being the day after operation. Patients were evaluated from...

  15. Methodological reporting quality of randomized controlled trials in three spine journals from 2010 to 2012.

    Science.gov (United States)

    Chen, Xiao; Zhai, Xiao; Wang, Xue; Su, Jiacan; Li, Ming

    2014-08-01

    To elucidate the methodological reporting quality of randomized controlled trials (RCTs) in three spine journals from 2010 to 2012. In this study, we summarized the methodological report of RCTs in three major spine journals, including the Spine Journal, Spine and the European Spine Journal from 2010 to 2012. The methodological reporting quality, including the allocation sequence generation, allocation concealment, blinding and sample size calculation, was revealed. Number of patients, funding source, type of intervention and country were also retrieved from each trial. The methodological reporting quality was descriptively reported. Ninety trials were involved and 57.8% (52/90) reported adequate allocation sequence generation, 46.7% (42/90) reported adequate allocation concealment, 34.4% (31/90) reported adequate blinding and 37.8% (34/90) reported adequate sample size calculation. This study shows that the methodological reporting quality of RCTs in the spine field needs further improvement.

  16. Hormone replacement therapy after breast cancer: attitudes of women eligible in a randomized trial.

    Science.gov (United States)

    Wallberg, B; von Schoultz, E; Bolund, C; Bergh, J; Wilking, N

    2009-12-01

    Objectives To investigate the attitudes of breast cancer patients who accepted or declined participation in a randomized trial with hormone replacement therapy that might increase their risk of recurrence (the Stockholm trial). Methods A total of 115 patients free from breast cancer recurrence were interviewed; 57 were participants and 58 were non-participants in the Stockholm trial. Patients answered five questionnaires regarding information needs (two), attitudes to participation in trials (two) and patient role in treatment decisions (one). Results Participants in the Stockholm trial had a lower risk of breast cancer recurrence (measured by node-positive disease and tumor size) and were older than non-participants. Their information needs were the same. Participants in the trial were more prepared to accept uncertainty, to have an altruistic attitude, to accept risks including an increased risk of recurrence of breast cancer, if their quality of life or general health was improved. Most patients preferred a collaborative role in relation to their physician but participants often wanted more influence than they had in treatment decisions. Conclusion A patient's decision to accept or decline participation in the Stockholm trial was influenced by her objective risk of breast cancer recurrence and reflected her attitude to risk, uncertainty and preference to be active in treatment decisions.

  17. Culturally appropriate storytelling to improve blood pressure: a randomized trial.

    Science.gov (United States)

    Houston, Thomas K; Allison, Jeroan J; Sussman, Marc; Horn, Wendy; Holt, Cheryl L; Trobaugh, John; Salas, Maribel; Pisu, Maria; Cuffee, Yendelela L; Larkin, Damien; Person, Sharina D; Barton, Bruce; Kiefe, Catarina I; Hullett, Sandral

    2011-01-18

    Storytelling is emerging as a powerful tool for health promotion in vulnerable populations. However, these interventions remain largely untested in rigorous studies. To test an interactive storytelling intervention involving DVDs. Randomized, controlled trial in which comparison patients received an attention control DVD. Separate random assignments were performed for patients with controlled or uncontrolled hypertension. (ClinicalTrials.gov registration number: NCT00875225) An inner-city safety-net clinic in the southern United States. 230 African Americans with hypertension. 3 DVDs that contained patient stories. Storytellers were drawn from the patient population. The outcomes were differential change in blood pressure for patients in the intervention versus the comparison group at baseline, 3 months, and 6 to 9 months. 299 African American patients were randomly assigned between December 2007 and May 2008 and 76.9% were retained throughout the study. Most patients (71.4%) were women, and the mean age was 53.7 years. Baseline mean systolic and diastolic pressures were similar in both groups. Among patients with baseline uncontrolled hypertension, reduction favored the intervention group at 3 months for both systolic (11.21 mm Hg [95% CI, 2.51 to 19.9 mm Hg]; P = 0.012) and diastolic (6.43 mm Hg [CI, 1.49 to 11.45 mm Hg]; P = 0.012) blood pressures. Patients with baseline controlled hypertension did not significantly differ over time between study groups. Blood pressure subsequently increased for both groups, but between-group differences remained relatively constant. This was a single-site study with 23% loss to follow-up and only 6 months of follow-up. The storytelling intervention produced substantial and significant improvements in blood pressure for patients with baseline uncontrolled hypertension. Finding Answers: Disparities Research for Change, a national program of the Robert Wood Johnson Foundation.

  18. A Meta-Analysis of Randomized Controlled Trials on Acupuncture for Amblyopia

    Directory of Open Access Journals (Sweden)

    Xingke Yan

    2013-01-01

    Full Text Available Objective. To assess the evidence of efficacy and safety of acupuncture for amblyopia and analyze the current situation of its clinical setting. Methods. We systemically searched Wanfang, Chongqing Weipu Database for Chinese Technical Periodicals (VIP, China National Knowledge Infrastructure (CNKI, and PubMed. Published randomized controlled trials (RCT and controlled clinical trials (CCT that evaluated the effect of acupuncture for amblyopia compared with conventional treatment were identified. The methodological quality of the included trials was assessed based on the Jadad scale. Data synthesis was facilitated using RevMan 5.1. Results. Fourteen trials involving 2662 participants satisfied the minimum criteria for meta-analysis. The evidence showed that the total effective rate of treatment within the group receiving acupuncture was higher than that in conventional group; there were statistically significant differences between groups (polled random effects model (RR = 1.17, 95% confidence interval (1.11, 1.24, Z=5.56, P<0.00001. Conclusion. The total effective rate of acupuncture for amblyopia was significantly superior to conventional treatment, indicating that acupuncture was a promising treatment for amblyopia. However, due to the limited number of CCTs and RCTs, especially those of large sample size and multicenter randomized controlled studies that were quantitatively insufficient, we could not reach a completely affirmative conclusion until further studies of high quality are available.

  19. Effects of telmisartan on proteinuria or albuminuria: a meta-analysis of randomized trials.

    Science.gov (United States)

    Takagi, Hisato; Yamamoto, Hirotaka; Iwata, Kotaro; Goto, Shin-Nosuke; Umemoto, Takuya

    2013-08-20

    Although telmisartan is suggested to improve proteinuria/albuminuria (or prevents progression of proteinuria/albuminuria), conclusive evidence is still lacking. We perform the first meta-analysis of randomized controlled trials of telmisartan therapy on proteinuria/albuminuria. MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched through February 2012. Eligible studies were prospective randomized controlled trials of telmisartan therapy versus other angiotensin receptor blocker (ARB), angiotensin converting enzyme inhibitor (ACEI), other anti-hypertensive drug therapy, placebo, or no medication and reporting urinary protein/albumin excretion (UPE/UAE) or urinary protein/albumin to creatinine ratio (UPCR/UACR) levels as an outcome. For each study, data regarding percent changes from baseline to final UPE/UAE/UPCR/UACR levels in both the telmisartan and control groups were used to generate mean differences (MDs) and 95% confidence intervals (CIs). Of 49 potentially relevant articles screened initially, 20 reports of randomized trials enrolling a total of 25,425 patients were included. Pooled analysis suggested a significant reduction in percent changes of UPE/UAE/UPCR/UACR in the 7 ARB-control (MD, -19.99%; 95% CI, -28.68% to -11.30%; p25,000 patients, telmisartan therapy is likely effective in the improvement of proteinuria/albuminuria or in the prevention of progression in proteinuria/albuminuria. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  20. The treatment of medial tibial stress syndrome in athletes; a randomized clinical trial.

    Science.gov (United States)

    Moen, Maarten Hendrik; Holtslag, Leonoor; Bakker, Eric; Barten, Carl; Weir, Adam; Tol, Johannes L; Backx, Frank

    2012-03-30

    The only three randomized trials on the treatment of MTSS were all performed in military populations. The treatment options investigated in this study were not previously examined in athletes. This study investigated if functional outcome of three common treatment options for medial tibial stress syndrome (MTSS) in athletes in a non-military setting was the same. The study design was randomized and multi-centered. Physical therapists and sports physicians referred athletes with MTSS to the hospital for inclusion. 81 athletes were assessed for eligibility of which 74 athletes were included and randomized to three treatment groups. Group one performed a graded running program, group two performed a graded running program with additional stretching and strengthening exercises for the calves, while group three performed a graded running program with an additional sports compression stocking. The primary outcome measure was: time to complete a running program (able to run 18 minutes with high intensity) and secondary outcome was: general satisfaction with treatment. 74 Athletes were randomized and included of which 14 did not complete the study due a lack of progress (18.9%). The data was analyzed on an intention-to-treat basis. Time to complete a running program and general satisfaction with the treatment were not significantly different between the three treatment groups. This was the first randomized trial on the treatment of MTSS in athletes in a non-military setting. No differences were found between the groups for the time to complete a running program. CCMO; NL23471.098.08.

  1. Huperzine A for Alzheimer's disease: a systematic review and meta-analysis of randomized clinical trials.

    Directory of Open Access Journals (Sweden)

    Guoyan Yang

    Full Text Available Huperzine A is a Chinese herb extract used for Alzheimer's disease. We conducted this review to evaluate the beneficial and harmful effect of Huperzine A for treatment of Alzheimer's disease.We searched for randomized clinical trials (RCTs of Huperzine A for Alzheimer's disease in PubMed, Cochrane Library, and four major Chinese electronic databases from their inception to June 2013. We performed meta-analyses using RevMan 5.1 software. (Protocol ID: CRD42012003249.20 RCTs including 1823 participants were included. The methodological quality of most included trials had a high risk of bias. Compared with placebo, Huperzine A showed a significant beneficial effect on the improvement of cognitive function as measured by Mini-Mental State Examination (MMSE at 8 weeks, 12 weeks and 16 weeks, and by Hastgawa Dementia Scale (HDS and Wechsler Memory Scale (WMS at 8 weeks and 12 weeks. Activities of daily living favored Huperzine A as measured by Activities of Daily Living Scale (ADL at 6 weeks, 12 weeks and 16 weeks. One trial found Huperzine A improved global clinical assessment as measured by Clinical Dementia Rating Scale (CDR. One trial demonstrated no significant change in cognitive function as measured by Alzheimer's disease Assessment Scale-Cognitive Subscale (ADAS-Cog and activity of daily living as measured by Alzheimer's disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL in Huperzine A group. Trials comparing Huperzine A with no treatment, psychotherapy and conventional medicine demonstrated similar findings. No trial evaluated quality of life. No trial reported severe adverse events of Huperzine A.Huperzine A appears to have beneficial effects on improvement of cognitive function, daily living activity, and global clinical assessment in participants with Alzheimer's disease. However, the findings should be interpreted with caution due to the poor methodological quality of the included trials.

  2. Herbal Medicines for Parkinson's Disease: A Systematic Review of Randomized Controlled Trials

    Science.gov (United States)

    Kim, Tae-Hun; Cho, Ki-Ho; Jung, Woo-Sang; Lee, Myeong Soo

    2012-01-01

    Objective We conducted systematic review to evaluate current evidence of herbal medicines (HMs) for Parkinson's disease (PD). Methods Along with hand searches, relevant literatures were located from the electronic databases including CENTRAL, MEDLINE, EMBASE, CINAHL, AMED, PsycInfo, CNKI, 7 Korean Medical Databases and J-East until August, 2010 without language and publication status. Randomized controlled trials (RCTs), quasi-randomized controlled trials and randomized crossover trials, which evaluate HMs for idiopathic PD were selected for this review. Two independent authors extracted data from the relevant literatures and any disagreement was solved by discussion. Results From the 3432 of relevant literatures, 64 were included. We failed to suggest overall estimates of treatment effects on PD because of the wide heterogeneity of used herbal recipes and study designs in the included studies. When compared with placebo, specific effects were not observed in favor of HMs definitely. Direct comparison with conventional drugs suggested that there was no evidence of better effect for HMs. Many studies compared combination therapy with single active drugs and combination therapy showed significant improvement in PD related outcomes and decrease in the dose of anti-Parkinson's drugs with low adverse events rate. Conclusion Currently, there is no conclusive evidence about the effectiveness and efficacy of HMs on PD. For establishing clinical evidence of HMs on PD, rigorous RCTs with sufficient statistical power should be promoted in future. PMID:22615738

  3. A Randomized Controlled Trial of Corticosteroids in Pediatric Septic Shock: A Pilot Feasibility Study.

    Science.gov (United States)

    Menon, Kusum; McNally, Dayre; O'Hearn, Katharine; Acharya, Anand; Wong, Hector R; Lawson, Margaret; Ramsay, Tim; McIntyre, Lauralyn; Gilfoyle, Elaine; Tucci, Marisa; Wensley, David; Gottesman, Ronald; Morrison, Gavin; Choong, Karen

    2017-06-01

    To determine the feasibility of conducting a randomized controlled trial of corticosteroids in pediatric septic shock. Randomized, double-blind, placebo controlled trial. Seven tertiary level PICUs in Canada. Children newborn to 17 years old inclusive with suspected septic shock. Administration of IV hydrocortisone versus placebo until hemodynamic stability is achieved or for a maximum of 7 days. One hundred seventy-four patients were potentially eligible of whom 101 patients met eligibility criteria. Fifty-seven patients were randomized, and 49 patients (23 and 26 patients in the hydrocortisone and placebo groups, respectively) were included in the final analysis. The mean time from screening to randomization was 2.4 ± 2.1 hours and from screening to first dose of study drug was 3.8 ± 2.6 hours. Forty-two percent of potentially eligible patients (73/174) received corticosteroids prior to randomization: 38.5% (67/174) were already on corticosteroids for shock at the time of screening, and in 3.4% (6/174), the treating physician wished to administer corticosteroids. Six of 49 randomized patients (12.2%) received open-label steroids, three in each of the hydrocortisone and placebo groups. Time on vasopressors, days on mechanical ventilation, PICU and hospital length of stay, and the rate of adverse events were not statistically different between the two groups. This study suggests that a large randomized controlled trial on early use of corticosteroids in pediatric septic shock is potentially feasible. However, the frequent use of empiric corticosteroids in otherwise eligible patients remains a significant challenge. Knowledge translation activities, targeted recruitment, and alternative study designs are possible strategies to mitigate this challenge.

  4. Re-evaluation of randomized control trials of lithium monotherapy: a cohort effect.

    Science.gov (United States)

    Deshauer, D; Fergusson, D; Duffy, A; Albuquerque, J; Grof, P

    2005-08-01

    The reported reduction of lithium's efficacy in the prophylaxis of bipolar illness has been attributed to various factors, including diagnostic changes and heterogeneous study designs. We attempted to quantify the impact of pre-randomization enrichment designs and diagnostic drift on randomized controlled trials (RCTs) of lithium maintenance therapy. Using the Cochrane RCT search filter, MEDLINE, EMBASE, and PSYCHINFO were searched (1966 to June 2004) for all available randomized studies using the text word 'lithium'. Studies of 1 year minimum duration in bipolar disorder involving lithium and placebo arms were identified. Superiority trials without a placebo arm, discontinuation and mirror image studies were excluded. Standardized scales were used to assess randomization and allocation concealment. Nine RCTs enrolling 1432 bipolar I and II patients, randomizing 341 to lithium and 386 to placebo were identified, with 705 reported pre-randomization dropouts. The pooled odds of remaining recurrence free in two non-enriched RCTS using Research Diagnostic Criteria (RDC) or Feighner criteria were 3.2:1 (95% CI 0.65--15.46) trending in favor of lithium over placebo, and 22.0:1 (95% CI 7.0--68.7) for three trials using lithium enrichment and excluding atypical bipolar disorder. The odds of remaining recurrence free using DSM-IV criteria and lamotrigine enrichment were 1.9:1 (95% CI 1.2-2.8). Lithium maintenance RCTs differ in patient selection, design, and outcome. A cohort effect can be associated with the use of pre-randomization enrichment phases and, to a lesser extent, with diagnostic drift, compromising straightforward comparisons across three decades of lithium monotherapy in bipolar illness.

  5. Heterogenic control groups in randomized, controlled, analgesic trials of total hip- and knee arthroplasty.

    Science.gov (United States)

    Karlsen, Anders P; Mathiesen, Ole; Dahl, Jørgen B

    2017-11-17

    Postoperative analgesic interventions are often tested adjunct to basic non- opioid analgesics in randomized controlled trials (RCTs). Consequently, treatment in control groups, and assay sensitivity, differs between trials. We hypothesized that postoperative opioid requirements and pain intensities varies between different control groups in analgesic trials. Control groups from RCTs investigating analgesic interventions after total hip and knee arthroplasty were categorized based on standardized basic analgesic treatment. Morphine consumption 0-24h postoperatively, and resting pain scores at 6 and 24 hours for subgroups of basic treatments, were compared with ANOVA. In an additional analysis, we compared pain and opioid requirements in trials where NSAID was administered as an intervention with trial where NSAID was administered in a control group. We included 171 RCTs employing 28 different control groups with large variability in pain scores and opioid requirements. Four types of control groups (comprising 78 trials) were eligi- ble for subgroup comparisons. These subgroups received: 'opioid', 'NSAID+opioid', 'acetamino- phen+opioid', or 'NSAID+acetaminophen+opioid'. Morphine consumption and pain scores varied substantially between these groups, with no consistent superior efficacy in any subgroup. Addi- tionally, trials administering NSAID as an intervention demonstrated lower pain scores and opioid requirements than trials where NSAID was administered in a control group. Analgesic treatment in RCT control groups varies considerably. Control groups receiving various combinations of opioid, NSAID and acetaminophen did not differ consistently in pain and opioid requirements. Pain and opioid requirements were lower in trials administering NSAID as an intervention compared with trials administering NSAID in a control group.

  6. Cognitive Function in a Randomized Trial of Evolocumab.

    Science.gov (United States)

    Giugliano, Robert P; Mach, François; Zavitz, Kenton; Kurtz, Christopher; Im, Kyungah; Kanevsky, Estella; Schneider, Jingjing; Wang, Huei; Keech, Anthony; Pedersen, Terje R; Sabatine, Marc S; Sever, Peter S; Robinson, Jennifer G; Honarpour, Narimon; Wasserman, Scott M; Ott, Brian R

    2017-08-17

    Background Findings from clinical trials of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors have led to concern that these drugs or the low levels of low-density lipoprotein (LDL) cholesterol that result from their use are associated with cognitive deficits. Methods In a subgroup of patients from a randomized, placebo-controlled trial of evolocumab added to statin therapy, we prospectively assessed cognitive function using the Cambridge Neuropsychological Test Automated Battery. The primary end point was the score on the spatial working memory strategy index of executive function (scores range from 4 to 28, with lower scores indicating a more efficient use of strategy and planning). Secondary end points were the scores for working memory (scores range from 0 to 279, with lower scores indicating fewer errors), episodic memory (scores range from 0 to 70, with lower scores indicating fewer errors), and psychomotor speed (scores range from 100 to 5100 msec, with faster times representing better performance). Assessments of cognitive function were performed at baseline, week 24, yearly, and at the end of the trial. The primary analysis was a noninferiority comparison of the mean change from baseline in the score on the spatial working memory strategy index of executive function between the patients who received evolocumab and those who received placebo; the noninferiority margin was set at 20% of the standard deviation of the score in the placebo group. Results A total of 1204 patients were followed for a median of 19 months; the mean (±SD) change from baseline over time in the raw score for the spatial working memory strategy index of executive function (primary end point) was -0.21±2.62 in the evolocumab group and -0.29±2.81 in the placebo group (Pfunction was observed over a median of 19 months. (Funded by Amgen; EBBINGHAUS ClinicalTrials.gov number, NCT02207634 .).

  7. An evaluation of the effectiveness of recruitment methods: the staying well after depression randomized controlled trial.

    Science.gov (United States)

    Krusche, Adele; Rudolf von Rohr, Isabelle; Muse, Kate; Duggan, Danielle; Crane, Catherine; Williams, J Mark G

    2014-04-01

    Randomized controlled trials (RCTs) are widely accepted as being the most efficient way of investigating the efficacy of psychological therapies. However, researchers conducting RCTs commonly report difficulties in recruiting an adequate sample within planned timescales. In an effort to overcome recruitment difficulties, researchers often are forced to expand their recruitment criteria or extend the recruitment phase, thus increasing costs and delaying publication of results. Research investigating the effectiveness of recruitment strategies is limited, and trials often fail to report sufficient details about the recruitment sources and resources utilized. We examined the efficacy of strategies implemented during the Staying Well after Depression RCT in Oxford to recruit participants with a history of recurrent depression. We describe eight recruitment methods utilized and two further sources not initiated by the research team and examine their efficacy in terms of (1) the return, including the number of potential participants who contacted the trial and the number who were randomized into the trial; (2) cost-effectiveness, comprising direct financial cost and manpower for initial contacts and randomized participants; and (3) comparison of sociodemographic characteristics of individuals recruited from different sources. Poster advertising, web-based advertising, and mental health worker referrals were the cheapest methods per randomized participant; however, the ratio of randomized participants to initial contacts differed markedly per source. Advertising online, via posters, and on a local radio station were the most cost-effective recruitment methods for soliciting participants who subsequently were randomized into the trial. Advertising across many sources (saturation) was found to be important. It may not be feasible to employ all the recruitment methods used in this trial to obtain participation from other populations, such as those currently unwell, or in

  8. Experiences of a long-term randomized controlled prevention trial in a maiden environment: Estonian Postmenopausal Hormone Therapy trial

    Directory of Open Access Journals (Sweden)

    Rahu Mati

    2008-08-01

    Full Text Available Abstract Background Preventive drugs require long-term trials to show their effectiveness or harms and often a lot of changes occur during post-marketing studies. The purpose of this article is to describe the research process in a long-term randomized controlled trial and discuss the impact and consequences of changes in the research environment. Methods The Estonian Postmenopausal Hormone Therapy trial (EPHT, originally planned to continue for five years, was planned in co-operation with the Women's International Study of Long-Duration Oestrogen after Menopause (WISDOM in the UK. In addition to health outcomes, EPHT was specifically designed to study the impact of postmenopausal hormone therapy (HT on health services utilization. Results After EPHT recruited in 1999–2001 the Women's Health Initiative (WHI in the USA decided to stop the estrogen-progestin trial after a mean of 5.2 years in July 2002 because of increased risk of breast cancer and later in 2004 the estrogen-only trial because HT increased the risk of stroke, decreased the risk of hip fracture, and did not affect coronary heart disease incidence. WISDOM was halted in autumn 2002. These decisions had a major influence on EPHT. Conclusion Changes in Estonian society challenged EPHT to find a balance between the needs of achieving responses to the trial aims with a limited budget and simultaneously maintaining the safety of trial participants. Flexibility was the main key for success. Rapid changes are not limited only to transiting societies but are true also in developed countries and the risk must be included in planning all long-term trials. The role of ethical and data monitoring committees in situations with emerging new data from other studies needs specification. Longer funding for preventive trials and more flexibility in budgeting are mandatory. Who should prove the effectiveness of an (old drug for a new preventive indication? In preventive drug trials companies may

  9. Family presence during brain death evaluation: a randomized controlled trial*.

    Science.gov (United States)

    Tawil, Isaac; Brown, Lawrence H; Comfort, David; Crandall, Cameron S; West, Sonlee D; Rollstin, Amber D; Dettmer, Todd S; Malkoff, Marc D; Marinaro, Jonathan

    2014-04-01

    To evaluate if a family presence educational intervention during brain death evaluation improves understanding of brain death without affecting psychological distress. Randomized controlled trial. Four ICUs at an academic tertiary care center. Immediate family members of patients suspected to have suffered brain death. Subjects were group randomized to presence or absence at bedside throughout the brain death evaluation with a trained chaperone. All randomized subjects were administered a validated "understanding brain death" survey before and after the intervention. Subjects were assessed for psychological well-being between 30 and 90 days after the intervention. Follow-up assessment of psychological well-being was performed using the Impact of Event Scale and General Health Questionnaire. Brain death understanding, Impact of Event Scale, and General Health Questionnaire scores were analyzed using Wilcoxon nonparametric tests. Analyses were adjusted for within family correlation. Fifty-eight family members of 17 patients undergoing brain death evaluation were enrolled: 38 family members were present for 11 brain death evaluations and 20 family members were absent for six brain death evaluations. Baseline understanding scores were similar between groups (median 3.0 [presence group] vs 2.5 [control], p = 0.482). Scores increased by a median of 2 (interquartile range, 1-2) if present versus 0 (interquartile range, 0-0) if absent (p Family presence during brain death evaluation improves understanding of brain death with no apparent adverse impact on psychological well-being. Family presence during brain death evaluation is feasible and safe.

  10. Placement Of Cardiac PacemaKEr Trial (POCKET) - rationale and design: a randomized controlled trial.

    Science.gov (United States)

    Magnusson, Peter; Wennström, Leo; Kastberg, Robert; Liv, Per

    2017-01-01

    A pacemaker system consists of one or two leads connected to a device that is implanted into a pocket formed just below the collarbone. This pocket is typically subcutaneous, that is, located just above the pectoral fascia. Even though the size of pacemakers has decreased markedly, complications due to superficial implants do occur. An alternative technique would be intramuscular placement of the pacemaker device, but there are no randomized controlled trials (RCTs) to support this approach, which is the rationale for the Placement Of Cardiac PacemaKEr Trial (POCKET). The aim is to study if intramuscular is superior to subcutaneous placement of a pacemaker pocket. In October 2016, we started to enroll 200 consecutive patients with an indication for bradycardia pacemaker implantation. Patients are randomized to random block sizes, stratified by age group (cut-off: 65 years) and sex, and then randomized to either subcutaneous or intramuscular implant. A concealed allocation procedure is employed, using sequentially numbered, sealed envelopes. Pocket site is blinded to the patient and in all subsequent care. The primary endpoint is patient overall satisfaction with the pocket location at 24 months as measured using a visual analog scale (VAS) 0-10. Secondary endpoints are: complications, patient-reported satisfaction at 1, 12, and 24 months (overall satisfaction, pain, discomfort, degree of unsightly appearance, movement problems, and sleep problems due to device). POCKET is a prospective interventional RCT designed to evaluate if intramuscular is superior to subcutaneous placement of a bradycardia pacemaker during a two-year follow-up.

  11. Industry Bias in Randomized Controlled Trials in General and Abdominal Surgery: An Empirical Study.

    Science.gov (United States)

    Probst, Pascal; Knebel, Phillip; Grummich, Kathrin; Tenckhoff, Solveig; Ulrich, Alexis; Büchler, Markus W; Diener, Markus K

    2016-07-01

    Industry sponsorship has been identified as a source of bias in several fields of medical science. To date, the influence of industry sponsorship in the field of general and abdominal surgery has not been evaluated. A systematic literature search (1985-2014) was performed in the Cochrane Library, MEDLINE, and EMBASE to identify randomized controlled trials in general and abdominal surgery. Information on funding source, outcome, and methodological quality was extracted. Association of industry sponsorship and positive outcome was expressed as odds ratio (OR) with 95% confidence interval (CI). A χ test and a multivariate logistic regression analysis with study characteristics and known sources of bias were performed. A total of 7934 articles were screened and 165 randomized controlled trials were included. No difference in methodological quality was found. Industry-funded trials more often presented statistically significant results for the primary endpoint (OR, 2.44; CI, 1.04-5.71; P = 0.04). Eighty-eight of 115 (76.5%) industry-funded trials and 19 of 50 (38.0%) non-industry-funded trials reported a positive outcome (OR, 5.32; CI, 2.60-10.88; P declaration of funding source. Industry involvement in surgical research has to ensure scientific integrity and independence and has to be based on full transparency.

  12. Massage Therapy and Labor Outcomes: a Randomized Controlled Trial

    Science.gov (United States)

    Janssen, Patricia; Shroff, Farah; Jaspar, Paula

    2012-01-01

    Introduction Massage is a time-honored method by which women have received comfort throughout the millennia, yet it has not been rigorously evaluated in the modern day delivery suite. No study to date that we are aware of has evaluated the effect of massage therapy by a regulated massage therapist on labor pain. The purpose of this study was to evaluate the effectiveness of massage therapy provided by registered massage therapists in managing pain among women in active labor. Methods BC Women’s Hospital, Vancouver, BC. Research Design: a randomized controlled trial. Participants: 77 healthy nulliparous women presenting in spontaneous labor. Intervention: Swedish massage administered for up to five hours by a registered massage therapist during labor vs. standard care. Main outcome measures include: cervical dilation at the time of administration of epidural, compared using estimated marginal means in an analysis of covariance. We also compared perception of pain at three time periods during labor according to cervical dilation at 3–4 cm, 5–7 cm, and 8–10 cm using the McGill Present Pain Intensity Scale. Results The mean cervical dilation at the time of epidural insertion after adjustment for station of the presenting part, cervical dilation, and status of membranes on admission to hospital was 5.9 cm (95% CI 5.2–6.7) compared to 4.9 in the control group (95% CI 4.2–5.8). Scores on the McGill Pain Scale were consistently lower in the massage therapy group (13.3 vs. 16.9 at 3–4 cm, 13.3 vs. 15.8 at 5–6 cm, and 19.4 vs. 28.3 at 7–8 cm), although these differences were not statistically significant. Conclusions Our findings from this pilot study suggest that massage therapy by a registered massage therapist has the potential to be an effective means of pain management that may be associated with delayed use of epidural analgesia. It may therefore have the potential to reduce exposure to epidural analgesia during labor and decrease rates of associated

  13. Acupuncture treatment of shoulder impingement syndrome: A randomized controlled trial.

    Science.gov (United States)

    Rueda Garrido, Juan Carlos; Vas, Jorge; Lopez, D Rafael

    2016-04-01

    Shoulder pain or omalgia is one of the main types of osteoarticular pain that can be observed in every-day clinical practice, frequently causing significant functional impairment. The most common cause of shoulder pain is impingement syndrome. To decrease the intensity of short- and mid-term pain in the injured shoulder by means of acupuncture. Randomized controlled trial with two groups of participants: one group received true acupuncture (TA) and the other received acupuncture at sham points (SA). The treatment was carried out over 4 weeks, with the participants receiving a session every week. The results were measured immediately after the treatment (T1) and 3 months later (T2). To evaluate the results, we used the 100 mm Visual Analogue Scale (VAS), and to assess the functionality of the shoulder we employed the UCLA questionnaire (0-35 points). A total of 68 participants were included in the analysis (TA, n=35; SA, n=33), with a mean age of 33.4 years (SD 12.53). We found significant differences in the analyzed results between the two groups, as we observed a decrease on the intensity of pain for the TA group of 44.13 mm at T1 (CI 95% 36.7; 51.5) and 87.58 mm at T2 (CI 95% 28.32; 46.81), while the decrease in the FA group was of 19.84 mm at T1 (CI 95% 12.2; 27.4) and 20 mm at T2 (CI 95% 10.9; 29.09). When the UCLA scores were analyzed, the results were clinically meaningful in support of TA in terms of functional assessment of the shoulder. No adverse effects were reported. The use of acupuncture to treat impingement syndrome seems to be a safe and reliable technique to achieve clinically significant results and could be implemented in the therapy options offered by the health services. Copyright © 2016 Elsevier Ltd. All rights reserved.

  14. Marine Oil Supplements for Arthritis Pain: A Systematic Review and Meta-Analysis of Randomized Trials

    Directory of Open Access Journals (Sweden)

    Ninna K. Senftleber

    2017-01-01

    Full Text Available Arthritis patients often take fish oil supplements to alleviate symptoms, but limited evidence exists regarding their efficacy. The objective was to evaluate whether marine oil supplements reduce pain and/or improve other clinical outcomes in patients with arthritis. Six databases were searched systematically (24 February 2015. We included randomized trials of oral supplements of all marine oils compared with a control in arthritis patients. The internal validity was assessed using the Cochrane Risk of Bias tool and heterogeneity was explored using restricted maximum of likelihood (REML-based meta-regression analysis. Grading of Recommendations Assessment, Development and Evaluation (GRADE was used to rate the overall quality of the evidence. Forty-two trials were included; 30 trials reported complete data on pain. The standardized mean difference (SMD suggested a favorable effect (−0.24; 95% confidence interval, CI, −0.42 to −0.07; heterogeneity, I2 = 63%. A significant effect was found in patients with rheumatoid arthritis (22 trials; −0.21; 95% CI, −0.42 to −0.004 and other or mixed diagnoses (3 trials; −0.63; 95% CI, −1.20 to −0.06, but not in osteoarthritis patients (5 trials; −0.17; 95% CI, −0.57–0.24. The evidence for using marine oil to alleviate pain in arthritis patients was overall of low quality, but of moderate quality in rheumatoid arthritis patients.

  15. Ethical Challenges of Randomized Violence Intervention Trials: Examining the SHARE intervention in Rakai, Uganda.

    Science.gov (United States)

    Wagman, Jennifer A; Paul, Amy; Namatovu, Fredinah; Ssekubugu, Robert; Nalugoda, Fred

    2016-07-01

    We identify complexities encountered, including unanticipated crossover between trial arms and inadequate 'standard of care' violence services, during a cluster randomized trial (CRT) of a community-level intimate partner violence (IPV) and HIV prevention intervention in Uganda. Concepts in public health ethics - beneficence, social value of research, fairness, standard of care, and researcher responsibilities for post-trial benefits - are used to critically reflect on lessons learned and guide discussion on practical and ethical challenges of violence intervention CRTs. Existing ethical guidelines provide incomplete guidance for responding to unexpected crossover in CRTs providing IPV services. We struggled to balance duty of care with upholding trial integrity, and identifying and providing appropriate standard of care. While we ultimately offered short-term IPV services to controls, we faced additional challenges related to sustaining services beyond the 'short-term' and post-trial. Studies evaluating community-level violence interventions, including those combined with HIV reduction strategies, are limited yet critical for developing evidence-based approaches for effectively preventing IPV. Although CRTs are a promising design, further guidance is needed to implement trials that avoid introducing tensions between validity of findings, researchers' responsibilities to protect participants, and equitable distribution of CRT benefits.

  16. Home medicines reviews following acute coronary syndrome: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bernal Daniel DL

    2012-04-01

    Full Text Available Abstract Background Despite continual improvements in the management of acute coronary syndromes, adherence to guideline-based medications remains suboptimal. We aim to improve adherence with guideline-based therapy following acute coronary syndrome using an existing service that is provided by specifically trained pharmacists, called a Home Medicines Review. We have made two minor adjustments to target the focus of the existing service including an acute coronary syndrome specific referral letter and a training package for the pharmacists providing the service. Methods/Design We will be conducting a randomized controlled trial to compare the directed home medicines review service to usual care following acute coronary syndromes. All patients aged 18 to 80 years and with a working diagnosis of acute coronary syndrome, who are admitted to two public, acute care hospitals, will be screened for enrolment into the trial. Exclusion criteria will include: not being discharged home, documented cognitive decline, non-Medicare eligibility, and presence of a terminal malignancy. Randomization concealment and sequence generation will occur through a centrally-monitored computer program. Patients randomized to the control group will receive usual post-discharge care. Patients randomized to receive the intervention will be offered usual post-discharge care and a directed home medicines review at two months post-discharge. The study endpoints will be six and twelve months post-discharge. The primary outcome will be the proportion of patients who are adherent to a complete, guideline-based medication regimen. Secondary outcomes will include hospital readmission rates, length of hospital stays, changes in quality of life, smoking cessation rates, cardiac rehabilitation completion rates, and mortality. Discussion As the trial is closely based on an existing service, any improvements observed should be highly translatable into regular practice. Possible

  17. Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions

    National Research Council Canada - National Science Library

    Freedland, Kenneth E; Mohr, David C; Davidson, Karina W; Schwartz, Joseph E

    2011-01-01

    To evaluate the use of existing practice control groups in randomized controlled trials of behavioral interventions and the role of extrinsic health care services in the design and conduct of behavioral trials...

  18. The effects of motivation feedback in patients with severe mental illness : A cluster randomized controlled trial

    NARCIS (Netherlands)

    Jochems, E.C.; van der Feltz-Cornelis, C.M.; van Dam, A.; Duivenvoorden, H.J.; Mulder, C.L.

    2015-01-01

    Objective: To evaluate the effectiveness of providing clinicians with regular feedback on the patient’s motivation for treatment in increasing treatment engagement in patients with severe mental illness. Methods: Design: cluster randomized controlled trial (Dutch Trials Registry NTR2968).

  19. The morbidity of treatment for patients with stage I endometrial cancer : Results from a randomized trial

    NARCIS (Netherlands)

    Creutzberg, CL; van Putten, WLJ; Koper, PC; Lybeert, MLM; Jobsen, JJ; Warlam-Rodenhuis, CC; De Winter, KAJ; Lutgens, LCHW; van den Bergh, ACM; van der Steen-Banasik, E; Beerman, H; van Lent, M

    2001-01-01

    Purpose: To compare the treatment complications for patients with Stage I endometrial cancer treated with surgery and pelvic radiotherapy (RT) or surgery alone in a multicenter randomized trial. Methods and Materials: The Postoperative Radiation Therapy in Endometrial Carcinoma (PORTEC) trial

  20. Sleep disorders in patients with depression or schizophrenia: A randomized controlled trial using acupuncture treatment

    NARCIS (Netherlands)

    Bosch, M.P.C.; Noort, M.W.M.L. van den; Staudte, H.; Lim, S.; Yeo, S.; Coenen, A.M.L.; Luijtelaar, E.L.J.M. van

    2016-01-01

    Introduction: The purpose of this preliminary clinical trial was to investigate whether acupuncture has a positive influence on sleep and symptomatology in patients with schizophrenia or depression. Methods: A randomized controlled trial was used. One hundred participants were recruited: 40

  1. Randomized trial of achieving healthy lifestyles in psychiatric rehabilitation: the ACHIEVE trial

    Directory of Open Access Journals (Sweden)

    Guallar Eliseo

    2010-12-01

    Full Text Available Abstract Background Overweight and obesity are highly prevalent among persons with serious mental illness. These conditions likely contribute to premature cardiovascular disease and a 20 to 30 percent shortened life expectancy in this vulnerable population. Persons with serious mental illness need effective, appropriately tailored behavioral interventions to achieve and maintain weight loss. Psychiatric rehabilitation day programs provide logical intervention settings because mental health consumers often attend regularly and exercise can take place on-site. This paper describes the Randomized Trial of Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE. The goal of the study is to determine the effectiveness of a behavioral weight loss intervention among persons with serious mental illness that attend psychiatric rehabilitation programs. Participants randomized to the intervention arm of the study are hypothesized to have greater weight loss than the control group. Methods/Design A targeted 320 men and women with serious mental illness and overweight or obesity (body mass index ≥ 25.0 kg/m2 will be recruited from 10 psychiatric rehabilitation programs across Maryland. The core design is a randomized, two-arm, parallel, multi-site clinical trial to compare the effectiveness of an 18-month behavioral weight loss intervention to usual care. Active intervention participants receive weight management sessions and physical activity classes on-site led by study interventionists. The intervention incorporates cognitive adaptations for persons with serious mental illness attending psychiatric rehabilitation programs. The initial intensive intervention period is six months, followed by a twelve-month maintenance period in which trained rehabilitation program staff assume responsibility for delivering parts of the intervention. Primary outcomes are weight loss at six and 18 months. Discussion Evidence-based approaches to the high burden

  2. Early biliary decompression versus conservative treatment in acute biliary pancreatitis (APEC trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Schepers, Nicolien J; Bakker, Olaf J; Besselink, Marc G H; Bollen, Thomas L; Dijkgraaf, Marcel G W; van Eijck, Casper H J; Fockens, Paul; van Geenen, Erwin J M; van Grinsven, Janneke; Hallensleben, Nora D L; Hansen, Bettina E; van Santvoort, Hjalmar C; Timmer, Robin; Anten, Marie-Paule G F; Bolwerk, Clemens J M; van Delft, Foke; van Dullemen, Hendrik M; Erkelens, G Willemien; van Hooft, Jeanin E; Laheij, Robert; van der Hulst, René W M; Jansen, Jeroen M; Kubben, Frank J G M; Kuiken, Sjoerd D; Perk, Lars E; de Ridder, Rogier J J; Rijk, Marno C M; Römkens, Tessa E H; Schoon, Erik J; Schwartz, Matthijs P; Spanier, B W Marcel; Tan, Adriaan C I T L; Thijs, Willem J; Venneman, Niels G; Vleggaar, Frank P; van de Vrie, Wim; Witteman, Ben J; Gooszen, Hein G; Bruno, Marco J

    2016-01-05

    Acute pancreatitis is mostly caused by gallstones or sludge. Early decompression of the biliary tree by endoscopic retrograde cholangiography (ERC) with sphincterotomy may improve outcome in these patients. Whereas current guidelines recommend early ERC in patients with concomitant cholangitis, early ERC is not recommended in patients with mild biliary pancreatitis. Evidence on the role of routine early ERC with endoscopic sphincterotomy in patients without cholangitis but with biliary pancreatitis at high risk for complications is lacking. We hypothesize that early ERC with sphincterotomy improves outcome in these patients. The APEC trial is a randomized controlled, parallel group, superiority multicenter trial. Within 24 hours after presentation to the emergency department, patients with biliary pancreatitis without cholangitis and at high risk for complications, based on an Acute Physiology and Chronic Health Evaluation (APACHE-II) score of 8 or greater, Modified Glasgow score of 3 or greater, or serum C-reactive protein above 150 mg/L, will be randomized. In 27 hospitals of the Dutch Pancreatitis Study Group, 232 patients will be allocated to early ERC with sphincterotomy or to conservative treatment. The primary endpoint is a composite of major complications (that is, organ failure, pancreatic necrosis, pneumonia, bacteremia, cholangitis, pancreatic endocrine, or exocrine insufficiency) or death within 180 days after randomization. Secondary endpoints include ERC-related complications, infected necrotizing pancreatitis, length of hospital stay and an economical evaluation. The APEC trial investigates whether an early ERC with sphincterotomy reduces the composite endpoint of major complications or death compared with conservative treatment in patients with biliary pancreatitis at high risk of complications. Current Controlled Trials ISRCTN97372133 (date registration: 17-12-2012).

  3. Sample size calculations for randomised trials including both independent and paired data.

    Science.gov (United States)

    Yelland, Lisa N; Sullivan, Thomas R; Price, David J; Lee, Katherine J

    2017-04-15

    Randomised trials including a mixture of independent and paired data arise in many areas of health research, yet methods for determining the sample size for such trials are lacking. We derive design effects algebraically assuming clustering because of paired data will be taken into account in the analysis using generalised estimating equations with either an independence or exchangeable working correlation structure. Continuous and binary outcomes are considered, along with three different methods of randomisation: cluster randomisation, individual randomisation and randomisation to opposite treatment groups. The design effect is shown to depend on the intracluster correlation coefficient, proportion of observations belonging to a pair, working correlation structure, type of outcome and method of randomisation. The derived design effects are validated through simulation and example calculations are presented to illustrate their use in sample size planning. These design effects will enable appropriate sample size calculations to be performed for future randomised trials including both independent and paired data. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  4. The Cessation in Pregnancy Incentives Trial (CPIT: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Tappin David M

    2012-07-01

    Full Text Available Abstract Background Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: ‘How to stop smoking in pregnancy and following childbirth’ (June 2010 highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? Design and methods This study is a phase II exploratory individually randomized controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy. Participants (n = 600 will be pregnant smokers identified at maternity booking who, when contacted by specialist cessation services, agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. The research questions are: What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomization an

  5. Validity of randomized clinical trials in gastroenterology from 1964-2000

    DEFF Research Database (Denmark)

    Kjaergard, Lise L; Frederiksen, Sarah L; Gluud, Christian

    2002-01-01

    The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000.......The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000....

  6. Methodological and ethical aspects of randomized controlled clinical trials in minors with malignant diseases.

    Science.gov (United States)

    Rothenberger, Lillian G; Henschel, Andreas Dirk; Schrey, Dominik; Becker, Andreas; Boos, Joachim

    2011-10-01

    Due to the new European regulations for pediatric medications, future clinical trials will include an increasing number of minors. It is therefore important to reconsider and evaluate recent methodological and ethical aspects of clinical trials in minors. The following questions were investigated: How are randomized controlled clinical trials (RCTs) performed in practice? Do investigators take into consideration biomedical ethical principles, explicated for example by Beauchamp and Childress, when planning and conducting a trial? The study was conducted in a descriptive manner. A systematic, algorithm-guided search focusing on RCTs in minors with malignant diseases was carried out in PubMed. One-thousand-nine-hundred-sixty-two publications from 2001 to 2005 were randomized in sequence. The first 1,000 publications were screened according to a priori defined inclusion criteria. One hundred seventy-five publications met the criteria and were reviewed using the SIGN methodological checklist (2004), the CONSORT Statement (2001, section Methods, items 3-12) and indicators for ethical aspects. Seventeen publications were checked by two raters. Information on randomization and blinding was often equivocal. The publications were mainly rated positive for the criteria of the SIGN checklist, and mostly rated negative for the additional items of the CONSORT Statement. Regarding the ethical principles, only few contributions were found in the publications. Inter-rater reliability was good. In the publications analyzed, we found only limited information concerning methods and reflections on ethical principles of the trials. Improvements are thus necessary and possible. We suggest how such trials and their respective publications can be optimized for these aspects. Copyright © 2011 Wiley-Liss, Inc.

  7. Quality of Reporting of Randomized Clinical Trials in Tai Chi Interventions—A Systematic Review

    Directory of Open Access Journals (Sweden)

    Jing-Yi Li

    2011-01-01

    Full Text Available Objectives. To evaluate the reporting quality of published randomized clinical trials (RCTs in the Tai Chi literature following the publication of the CONSORT guidelines in 2001. Data Sources. The OVID MEDLINE and PUBMED databases. Review Methods. To survey the general characteristics of Tai Chi RCTs in the literature, we included any report if (i it was an original report of the trial; (ii its design was RCT; (iii one of the treatments being tested was Tai Chi; and (iv it was in English. In addition, we assessed the reporting quality of RCTs that were published between 2002 and 2007, using a modified CONSORT checklist of 40 items. The adequate description of Tai Chi interventions in these trials was examined against a 10-item checklist adapted from previous reviews. Results. The search yielded 31 Tai Chi RCTs published from 2002 to 2007 and only 11 for 1992–2001. Among trials published during 2002–2007, the most adequately reported criteria were related to background, participant eligibility and interpretation of the study results. Nonetheless, the most poorly reported items were associated with randomization allocation concealment, implementation of randomization and the definitions of period of recruitment and follow-up. In addition, only 23% of RCTs provided adequate details of Tai Chi intervention used in the trials. Conclusion. The findings in this review indicated that the reporting quality of Tai Chi intervention trials is sub-optimal. Substantial improvement is required to meet the CONSORT guidelines and allow assessment of the quality of evidence. We believe that not only investigators, but also journal editors, reviewers and funding agencies need to follow the CONSORT guidelines to improve the standards of research and strengthen the evidence base for Tai Chi and for complementary and alternative medicine.

  8. Naturopathic care for chronic low back pain: a randomized trial.

    Directory of Open Access Journals (Sweden)

    Orest Szczurko

    Full Text Available OBJECTIVE: Chronic low back pain represents a substantial cost to employers through benefits coverage and days missed due to incapacity. We sought to explore the effectiveness of Naturopathic care on chronic low back pain. METHODS: This study was a randomized clinical trial. We randomized 75 postal employees with low back pain of longer than six weeks duration to receive Naturopathic care (n = 39 or standardized physiotherapy (n = 36 over a period of 12 weeks. The study was conducted in clinics on-site in postal outlets. Participants in the Naturopathic care group received dietary counseling, deep breathing relaxation techniques and acupuncture. The control intervention received education and instruction on physiotherapy exercises using an approved education booklet. We measured low back pain using the Oswestry disability questionnaire as the primary outcome measure, and quality of life using the SF-36 in addition to low back range of motion, weight loss, and Body Mass Index as secondary outcomes. RESULTS: Sixty-nine participants (92% completed eight weeks or greater of the trial. Participants in the Naturopathic care group reported significantly lower back pain (-6.89, 95% CI. -9.23 to -3.54, p = <0.0001 as measured by the Oswestry questionnaire. Quality of life was also significantly improved in the group receiving Naturopathic care in all domains except for vitality. Differences for the aggregate physical component of the SF-36 was 8.47 (95% CI, 5.05 to 11.87, p = <0.0001 and for the aggregate mental component was 7.0 (95% CI, 2.25 to 11.75, p = 0.0045. All secondary outcomes were also significantly improved in the group receiving Naturopathic care: spinal flexion (p<0.0001, weight-loss (p = 0.0052 and Body Mass Index (-0.52, 95% CI, -0.96 to -0.08, p = 0.01. CONCLUSIONS: Naturopathic care provided significantly greater improvement than physiotherapy advice for patients with chronic low back pain. TRIAL REGISTRATION: Controlled-Trials

  9. ORCHIDS: an Observational Randomized Controlled Trial on Childhood Differential Susceptibility

    Directory of Open Access Journals (Sweden)

    Chhangur Rabia R

    2012-10-01

    Full Text Available Abstract Background A central tenet in developmental psychopathology is that childhood rearing experiences have a major impact on children’s development. Recently, candidate genes have been identified that may cause children to be differentially susceptible to these experiences (i.e., susceptibility genes. However, our understanding of the differential impact of parenting is limited at best. Specifically, more experimental research is needed. The ORCHIDS study will investigate gene-(gene-environment interactions to obtain more insight into a moderating effects of polymorphisms on the link between parenting and child behavior, and b behavioral mechanisms that underlie these gene-(gene-environment interactions in an experimental design. Methods/Design The ORCHIDS study is a randomized controlled trial, in which the environment will be manipulated with an intervention (i.e., Incredible Years parent training. In a screening, families with children aged 4–8 who show mild to (subclinical behavior problems will be targeted through community records via two Dutch regional healthcare organizations. Assessments in both the intervention and control condition will be conducted at baseline (i.e., pretest, after 6 months (i.e., posttest, and after 10 months (i.e., follow-up. Discussion This study protocol describes the design of a randomized controlled trial that investigates gene-(gene-environment interactions in the development of child behavior. Two hypotheses will be tested. First, we expect that children in the intervention condition who carry one or more susceptibility genes will show significantly lower levels of problem behavior and higher levels of prosocial behavior after their parent(s received the Incredible Years training, compared to children without these genes, or children in the control group. Second, we expect that children carrying one or more susceptibility genes will show a heightened sensitivity to changes in parenting behaviors, and

  10. Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011.

    Science.gov (United States)

    Doshi, Peter; Hur, Peter; Jones, Mark; Albarmawi, Husam; Jefferson, Tom; Morgan, Daniel J; Spears, Patricia A; Powers, John H

    2017-10-01

    Potential research participants may assume that randomized trials comparing new interventions with older interventions always hypothesize greater efficacy for the new intervention, as in superiority trials. However, antibiotic trials frequently use "noninferiority" hypotheses allowing a degree of inferior efficacy deemed "clinically acceptable" compared with an older effective drug, in exchange for nonefficacy benefits (eg, decreased adverse effects). Considering these different benefit-harm trade-offs, proper informed consent necessitates supplying different information on the purposes of superiority and noninferiority trials. To determine the degree to which the study purpose is explained to potential participants in randomized clinical trials of antibiotics and the degree to which study protocols justify their selection of noninferiority hypotheses and amount of "clinically acceptable" inferiority. Cross-sectional analysis of study protocols, statistical analysis plans (SAPs), and informed consent forms (ICFs) from clinical study reports submitted to the European Medicines Agency. The ICFs were read by both methodologists and patient investigators. Protocols and SAPs were used as the reference standard to determine prespecified primary hypothesis and record rationale for selection of noninferiority hypotheses and noninferiority margins. This information was cross-referenced against ICFs to determine whether ICFs explained the study purpose. We obtained trial documents from 78 randomized trials with prespecified efficacy hypotheses (6 superiority, 72 noninferiority) for 17 antibiotics conducted between 1991 and 2011 that enrolled 39 407 patients. Fifty were included in the ICF analysis. All ICFs contained sections describing study purpose; however, none consistently conveyed study hypothesis to both methodologists and patient investigators. Methodologists found that 1 of 50 conveyed a study purpose. Patient investigators found that 11 of 50 conveyed a study

  11. Reducing therapeutic misconception: A randomized intervention trial in hypothetical clinical trials.

    Science.gov (United States)

    Christopher, Paul P; Appelbaum, Paul S; Truong, Debbie; Albert, Karen; Maranda, Louise; Lidz, Charles

    2017-01-01

    Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as therapeutic misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces therapeutic misconception without significantly reducing willingness to participate in hypothetical clinical trials. This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control) in reducing therapeutic misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were therapeutic misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range = 10-50), and willingness to participate in the clinical trial. 154 participants completed the study (age range, 23-87 years; 92.3% white, 56.5% female); 74 (48.1%) had been randomized to receive the experimental intervention. Therapeutic misconception was significantly lower (p = 0.004) in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p = 0.017). Willingness to participate in the hypothetical trial was not significantly different (p = 0.603) between intervention (52.1%, 95% CI [40.2% to 62.4%]) and control (56.3%, 95% CI [45.3% to 66.6%] groups. An enhanced educational intervention augmenting

  12. Effect of a mobile app intervention on vegetable consumption in overweight adults: a randomized controlled trial

    National Research Council Canada - National Science Library

    Sarah Mummah; Thomas N Robinson; Maya Mathur; Sarah Farzinkhou; Stephen Sutton; Christopher D Gardner

    2017-01-01

    Background Mobile applications (apps) have been heralded as transformative tools to deliver behavioral health interventions at scale, but few have been tested in rigorous randomized controlled trials...

  13. The reporting of blinding in physical medicine and rehabilitation randomized controlled trials: a systematic review

    National Research Council Canada - National Science Library

    Villamar, Mauricio F; Contreras, Vanessa Suárez; Kuntz, Richard E; Fregni, Felipe

    2013-01-01

    .... We searched MEDLINE via PubMed for all randomized controlled trials published in American Journal of Physical Medicine and Rehabilitation, Archives of Physical Medicine and Rehabilitation, Clinical...

  14. Randomized trial testing the effect of peer education at increasing fruit and vegetable intake

    National Research Council Canada - National Science Library

    Buller, D B; Morrill, C; Taren, D; Aickin, M; Sennott-Miller, L; Buller, M K; Larkey, L; Alatorre, C; Wentzel, T M

    1999-01-01

    .... In a randomized trial, peer education was tested for effectiveness at increasing fruit and vegetable intake among lower socioeconomic, multicultural labor and trades employees. Employees (n = 2091...

  15. Imipramine and Pregabalin Combination for Painful Polyneuropathy. A Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Holbech, Jakob V; Bach, Flemming W; Finnerup, Nanna B

    2015-01-01

    Monotherapy with first-line drugs for neuropathic pain often fails to provide sufficient pain relief or has unacceptable side effects because of the need for high doses. The aim of this trial was to test whether the combination of imipramine and pregabalin in moderate doses would relieve pain more...... effectively than monotherapy with either of the drugs. This was a randomized, double-blind, placebo-controlled, crossover, multicenter trial consisting of four 5-week treatment periods in patients with painful polyneuropathy. Treatment arms were imipramine 75 mg/d vs pregabalin 300 mg/d vs combination therapy...... randomized, and 69 patients were included in the data analysis. The effect on average pain in comparison with placebo was: combination (-1.67 NRS points, P pregabalin (-0.48 NRS points, P = 0.03). The combination therapy had significantly lower pain...

  16. Issues relating to study design and risk of bias when including non-randomized studies in systematic reviews on the effects of interventions.

    Science.gov (United States)

    Higgins, Julian Pt; Ramsay, Craig; Reeves, Barnaby C; Deeks, Jonathan J; Shea, Beverley; Valentine, Jeffrey C; Tugwell, Peter; Wells, George

    2013-03-01

    Non-randomized studies may provide valuable evidence on the effects of interventions. They are the main source of evidence on the intended effects of some types of interventions and often provide the only evidence about the effects of interventions on long-term outcomes, rare events or adverse effects. Therefore, systematic reviews on the effects of interventions may include various types of non-randomized studies. In this second paper in a series, we address how review authors might articulate the particular non-randomized study designs they will include and how they might evaluate, in general terms, the extent to which a particular non-randomized study is at risk of important biases. We offer guidance for describing and classifying different non-randomized designs based on specific features of the studies in place of using non-informative study design labels. We also suggest criteria to consider when deciding whether to include non-randomized studies. We conclude that a taxonomy of study designs based on study design features is needed. Review authors need new tools specifically to assess the risk of bias for some non-randomized designs that involve a different inferential logic compared with parallel group trials. Copyright © 2012 John Wiley & Sons, Ltd. Copyright © 2012 John Wiley & Sons, Ltd.

  17. Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP study): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ito, Masaya; Okumura, Yasuyuki; Horikoshi, Masaru; Kato, Noriko; Oe, Yuki; Miyamae, Mitsuhiro; Hirabayashi, Naotsugu; Kanie, Ayako; Nakagawa, Atsuo; Ono, Yutaka

    2016-03-18

    The unified protocol for the transdiagnostic treatment of emotional disorders is a promising treatment approach that could be applicable to a broad range of mental disorders, including depressive, anxiety, trauma-related, and obsessive-compulsive disorders. However, no randomized controlled trial has been conducted to verify the efficacy of the unified protocol on the heterogeneous clinical population with depressive and anxiety disorders. The trial was designed as a single-center, assessor-blinded, randomized, 20-week, parallel-group superiority study in order to compare the efficacy of the combination of unified protocol and treatment-as-usual versus waiting-list with treatment-as-usual for patients with depressive and/or anxiety disorders. The primary outcome was depression at 21 weeks, assessed by the 17-item version of the GRID-Hamilton Rating Scale for Depression. Estimated minimum sample size was 27 participants in each group. We will also examine the treatment mechanisms, treatment processes, and neuropsychological correlates. The results of this study will clarify the efficacy of the unified protocol for depressive and anxiety disorders, and the treatment mechanism, process, and neurological correlates for the effectiveness of the unified protocol. If its efficacy can be confirmed, the unified protocol may be of high clinical value for Japan, a country in which cognitive behavioral treatment has not yet been widely adopted. ClinicalTrials.gov NCT02003261 (registered on December 2, 2013).

  18. Effect of music in endoscopy procedures: systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Wang, Man Cai; Zhang, Ling Yi; Zhang, Yu Long; Zhang, Ya Wu; Xu, Xiao Dong; Zhang, You Cheng

    2014-10-01

    Endoscopies are common clinical examinations that are somewhat painful and even cause fear and anxiety for patients. We performed this systematic review and meta-analysis of randomized controlled trials to determine the effect of music on patients undergoing various endoscopic procedures. We searched the Cochrane Library, Issue 6, 2013, PubMed, and EMBASE databases up to July 2013. Randomized controlled trials comparing endoscopies, with and without the use of music, were included. Two authors independently abstracted data and assessed risk of bias. Subgroup analyses were performed to examine the impact of music on different types of endoscopic procedures. Twenty-one randomized controlled trials involving 2,134 patients were included. The overall effect of music on patients undergoing a variety of endoscopic procedures significantly improved pain score (weighted mean difference [WMD] = -1.53, 95% confidence interval [CI] [-2.53, -0.53]), anxiety (WMD = -6.04, 95% CI [-9.61, -2.48]), heart rate (P = 0.01), arterial pressure (P music group, compared with the control group. Furthermore, music had little effect for patients undergoing colposcopy and bronchoscopy in the subanalysis. Our meta-analysis suggested that music may offer benefits for patients undergoing endoscopy, except in colposcopy and bronchoscopy. Wiley Periodicals, Inc.

  19. Perceived information gain from randomized trials correlates with publication in high-impact factor journals.

    Science.gov (United States)

    Evangelou, Evangelos; Siontis, Konstantinos C; Pfeiffer, Thomas; Ioannidis, John P A

    2012-12-01

    To examine whether perceived information gain (IG) drives the publication of randomized trials in high-impact factor (IF) journals. We estimated IG as the Kullback-Leibler divergence, quantifying how much a new finding changes established knowledge. We used 67 meta-analyses (964 randomized trials) that include one or more trials from any of the three highest IF general medical journals (NEJM, JAMA, and Lancet). We calculated IG for the presence of a non-null effect (IG(1)) and IG for the effect size magnitude (IG(2)). Across meta-analyses, the summary correlation coefficient of IF was 0.23 (95% confidence interval [CI]: 0.14, 0.31) for IG(1) and 0.35 (95% CI: 0.25, 0.46) for IG(2). IF also correlated with the P-value of the results (r=0.18), order of publication (r=-0.13), and number of events in the trial (r=0.36). Multivariate regression including IG, order of publication, P-value, and the number of events showed that IG is an independent correlate of IF. IG(2) explained a substantially larger proportion of the variance in IF than IG(1). Publication in journals with high IF is driven by how extensively the results of a study change prior perceptions of the evidence, independently of the statistical significance and size of the study. Copyright © 2012. Published by Elsevier Inc.

  20. Effect of laser acupuncture on obesity: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Tseng, Chi-Chuan; Tseng, Alan; Chang, Chia-Hao

    2015-05-15

    Obesity-related diseases have a profound economic impact on health care systems. Laser acupuncture has been shown to have beneficial effects on obesity. However, to our knowledge, those trials were either non-randomized, non-blinded or included low-calorie diet control. We have, therefore, designed a patient-assessor-blinded, randomized, sham-controlled crossover trial to investigate the significance of laser acupuncture on obesity. 104 subjects above 20 years of age with a body mass index (BMI) of over 25 kg/m(2) will be divided into 2 groups: experimental and control. Each subject will receive the treatment relevant to their group 3 times a week for 8 weeks. After 8 weeks of treatment the subject will enter a 2-week washout period, after which the subjects will switch groups. Measurements will include BMI, body fat percentage, waist-to-hip ratio (WHR), waist circumference, hip circumference, skinfold thickness, thigh circumference, body fat, blood pressure, heart rate, hunger and the 36-item Short-Form Health Survey (SF-36). The results of this study will provide the basis for future large-scale multicenter trials investigating the effects of laser acupuncture on obesity. ClinicalTrials.gov Identifier: NCT02167308 ; registration date: 14 June 2014.

  1. Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial

    Science.gov (United States)

    2017-03-01

    Psychology : Research and Practice) with VA colleagues. This paper is not included as an appendix because it was not funded by this project. MONTHS 1-6...Phase I – Preparation and Regulatory Review • Months 1-6: Obtain IRB approvals to conduct a clinical trial using human subjects See status below...ORP, Human Research Protection Office (HRPO), and Madigan Army Medical Center Department of Clinical Investigation (DCI); (b) prepare manuscripts

  2. Music listening for anxiety relief in children in the preoperative period: a randomized clinical trial

    National Research Council Canada - National Science Library

    Franzoi, Mariana André Honorato; Goulart, Cristina Bretas; Lara, Elizabete Oliveira; Martins, Gisele

    2016-01-01

    ...: randomized controlled clinical trial pilot study with 52 children in the preoperative period, aged 3 to 12 years, undergoing elective surgery and randomly allocated in the experimental group (n = 26) and control group (n = 26...

  3. Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trial.

    Science.gov (United States)

    Maruani, Annabel; Boutron, Isabelle; Baron, Gabriel; Ravaud, Philippe

    2014-09-19

    To evaluate the impact of sending an email to responsible parties of completed trials that do not comply with the Food and Drug Administration Amendments Act 801 legislation, to remind them of the legal requirement to post results. Cohort embedded pragmatic randomized controlled trial. Trials registered on ClinicalTrials.gov. 190 out of 379 trials randomly selected by computer generated randomization list to receive the intervention (personalized emails structured as a survey and sent by one of us to responsible parties of the trials, indirectly reminding them of the legal requirement and potential penalties for non-compliance). The primary outcome was the proportion of results posted on ClinicalTrials.gov at three months. The secondary outcome was the proportion posted at six months. In a second step, two assessors blinded to the intervention group collected the date of the first results being received on ClinicalTrials.gov. A post hoc sensitivity analysis excluding trials wrongly included was performed. Among 379 trials included, 190 were randomized to receive the email intervention. The rate of posting of results did not differ at three months between trials with or without the intervention: 36/190 (19%) v 24/189 (13%), respectively (relative risk 1.5, 95% confidence interval 0.9 to 2.4, P=0.096) but did at six months: 46/190 (24%) v 27/189 (14%), 1.7, 1.1 to 2.6, P=0.014. In the sensitivity analysis, which excluded 48/379 trials (13%), 26/190 (14%) and 22/189 (12%), respectively, results were significant at three months (relative risk 5.1, 1.1 to 22.9, P=0.02) and at six months (4.1, 1.3 to 10.6, P=0.001). Sending email reminders about the FDA's legal requirement to post results at ClinicalTrials.gov improved significantly the posting rate at six months but not at three months.Trial registration ClinicalTrials.gov NCT01658254. © Maruani et al 2014.

  4. Cognitive Stimulation in Patients with Dementia: Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Daniela Mapelli

    2013-08-01

    Full Text Available Background/Aims: This study explores the effective outcomes of a structured cognitive stimulation treatment to improve cognition and behavioral symptoms in people with dementia (PWDs, using a randomized controlled clinical trial. Methods: Thirty PWDs were divided into three groups: experimental (treated with cognitive stimulation, placebo (treated with occupational therapy, and control (continuing with the usual activities of the nursing home. Assessment, at baseline and after a period of 8 weeks, was performed using the Clinical Dementia Rating Scale, activities of daily living, Mini-Mental State Examination, Esame Neuropsicologico Breve 2, Geriatric Depression Scale and Behavioral Pathology in Alzheimer's Disease Scale. Results: Only the experimental group improved its performance in cognitive tests (p Conclusions: The results suggest that a cognitive stimulation treatment for PWDs would improve not only their cognition, but also behavioral symptoms.

  5. Acupucture as pain relief during delivery - a randomized controlled trial

    DEFF Research Database (Denmark)

    Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten

    2009-01-01

    with the intention-to-treat principle. Results: Use of pharmacological and invasive methods was significantly lower in the acupuncture group (acupuncture vs traditional, p acupuncture vs TENS, p = 0.031). Pain scores were comparable. Acupuncture did not influence the duration of labor or the use of oxytocin......Background: Many women need some kind of analgesic treatment to relieve pain during childbirth. The objective of our study was to compare the effect of acupuncture with transcutaneous electric nerve stimulation (TENS) and traditional analgesics for pain relief and relaxation during delivery...... with respect to pain intensity, birth experience, and obstetric outcome. Methods: A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain...

  6. Acupuncture as pain relief during delivery: a randomized controlled trial

    DEFF Research Database (Denmark)

    Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten

    2009-01-01

    with the intention-to-treat principle. RESULTS: Use of pharmacological and invasive methods was significantly lower in the acupuncture group (acupuncture vs traditional, p acupuncture vs TENS, p = 0.031). Pain scores were comparable. Acupuncture did not influence the duration of labor or the use of oxytocin......BACKGROUND: Many women need some kind of analgesic treatment to relieve pain during childbirth. The objective of our study was to compare the effect of acupuncture with transcutaneous electric nerve stimulation (TENS) and traditional analgesics for pain relief and relaxation during delivery...... with respect to pain intensity, birth experience, and obstetric outcome. METHODS: A randomized controlled trial was conducted with 607 healthy women in labor at term who received acupuncture, TENS, or traditional analgesics. Primary outcomes were the need for pharmacological and invasive methods, level of pain...

  7. Fundamentals of randomized clinical trials in wound care

    DEFF Research Database (Denmark)

    Brölmann, Fleur E; Eskes, Anne M; Sumpio, Bauer E

    2013-01-01

    . Randomized clinical trials (RCTs) are universally acknowledged as the study design of choice for comparing treatment effects. To give high-level evidence the appreciation it deserves in wound care, we propose a step-by-step reporting standard for comprehensive and transparent reporting of RCTs in wound care......In wound care research, available high-level evidence according to the evidence pyramid is rare, and is threatened by a poor study design and reporting. Without comprehensive and transparent reporting, readers will not be able to assess the strengths and limitations of the research performed....... Critical reporting issues (e.g., wound care terminology, blinding, predefined outcome measures, and a priori sample size calculation) and wound-specific barriers (e.g., large diversity of etiologies and comorbidities of patients with wounds) that may prevent uniform implementation of reporting standards...

  8. Effects of nattokinase on blood pressure: a randomized, controlled trial.

    Science.gov (United States)

    Kim, Ji Young; Gum, Si Nae; Paik, Jean Kyung; Lim, Hyo Hee; Kim, Kyong-Chol; Ogasawara, Kazuya; Inoue, Kenichi; Park, Sungha; Jang, Yangsoo; Lee, Jong Ho

    2008-08-01

    The objective of this study was to examine the effects of nattokinase supplementation on blood pressure in subjects with pre-hypertension or stage 1 hypertension. In a randomized, double-blind, placebo-controlled trial, 86 participants ranging from 20 to 80 years of age with an initial untreated systolic blood pressure (SBP) of 130 to 159 mmHg received nattokinase (2,000 FU/capsule) or a placebo capsule for 8 weeks. Seventy-three subjects completed the protocol. Compared with the control group, the net changes in SBP and diastolic blood pressure (DBP) were -5.55 mmHg (95% confidence interval [CI], -10.5 to -0.57 mmHg; pnattokinase group compared with the control group (pnattokinase supplementation resulted in a reduction in SBP and DBP. These findings suggest that increased intake of nattokinase may play an important role in preventing and treating hypertension.

  9. Randomized Trial of a Brief Depression Prevention Program

    Science.gov (United States)

    Stice, Eric; Burton, Emily; Bearman, Sarah Kate; Rohde, Paul

    2008-01-01

    This trial compared a brief group cognitive-behavioral (CBT) depression prevention program to a waitlist control condition and four placebo or alternative interventions. High-risk adolescents with elevated depressive symptoms (N = 225, M age = 18, 70% female) were randomized to CBT, supportive-expressive group intervention, bibliotherapy, expressive writing, journaling, or waitlist conditions and completed assessments at baseline, termination, and 1-month and 6-month follow-up. All five active interventions showed significantly greater reductions in depressive symptoms at termination than waitlist controls; effects for CBT and bibliotherapy persisted into follow-up. CBT, supportive-expressive, and bibliotherapy participants also showed significantly greater decreases in depressive symptoms than expressive writing and journaling participants at certain follow-up points. Findings suggest there may be multiple ways to reduce depressive symptoms in high-risk adolescents, although expectancies, demand characteristics, and attention may have contributed to the observed effects. PMID:17007812

  10. Pretravel Health Advice Among Australians Returning From Bali, Indonesia: A Randomized Controlled Trial Protocol.

    Science.gov (United States)

    Thomson, Chloe A; Gibbs, Robyn A; Heyworth, Jane S; Giele, Carolien; Firth, Martin J; Effler, Paul V

    2016-12-07

    The effect of pretravel health advice (PTHA) on travel-related illness rates is poorly understood, and to date there are no published randomized controlled trials evaluating the impact of PTHA outcomes. This study aims to determine the effect of an online PTHA intervention on travel-related illness rates in Western Australians visiting Bali, Indonesia. Western Australian travelers to Bali will be recruited online before departure and will be randomly allocated to an intervention or control group by computer algorithm. The intervention in this study is a short animated video, with accompanying text, containing PTHA relevant to Bali. An online posttravel survey will be administered to all participants within two weeks of their return from Bali. The primary outcome is the difference in self-reported travel-related illness rates between control and intervention groups. Secondary outcomes include the difference in risk prevention behaviors and health risk knowledge between the control and intervention groups. Further secondary outcomes include whether individuals in the control group who sought external PTHA differ from those who did not with respect to risk prevention behaviors, health risk knowledge, and health risk perception, as well as the rate of self-reported travel-related illness. The study began recruitment in September 2016 and will conclude in September 2017. Data analysis will take place in late 2017, with results disseminated via peer-reviewed journals in early 2018. This will be the first randomized controlled trial to examine the effect of a novel PTHA intervention upon travel-related illness. In addition, this study builds upon the limited existing data on the effectiveness of PTHA on travel-related illness. Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12615001230549; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369567 (Archived by WebCite at http://www.webcitation.org/6m0G7xJg1).

  11. Effect of a mobile app intervention on vegetable consumption in overweight adults: a randomized controlled trial.

    Science.gov (United States)

    Mummah, Sarah; Robinson, Thomas N; Mathur, Maya; Farzinkhou, Sarah; Sutton, Stephen; Gardner, Christopher D

    2017-09-15

    Mobile applications (apps) have been heralded as transformative tools to deliver behavioral health interventions at scale, but few have been tested in rigorous randomized controlled trials. We tested the effect of a mobile app to increase vegetable consumption among overweight adults attempting weight loss maintenance. Overweight adults (n=135) aged 18-50 years with BMI=28-40 kg/m 2 near Stanford, CA were recruited from an ongoing 12-month weight loss trial (parent trial) and randomly assigned to either the stand-alone, theory-based Vegethon mobile app (enabling goal setting, self-monitoring, and feedback and using "process motivators" including fun, surprise, choice, control, social comparison, and competition) or a wait-listed control condition. The primary outcome was daily vegetables servings, measured by an adapted Harvard food frequency questionnaire (FFQ) 8 weeks post-randomization. Daily vegetable servings from 24-hour dietary recalls, administered by trained, certified, and blinded interviewers 5 weeks post-randomization, was included as a secondary outcome. All analyses were conducted according to principles of intention-to-treat. Daily vegetable consumption was significantly greater in the intervention versus control condition for both measures (adjusted mean difference: 2.0 servings; 95% CI: 0.1, 3.8, p=0.04 for FFQ; and 1.0 servings; 95% CI: 0.2, 1.9; p=0.02 for 24-hour recalls). Baseline vegetable consumption was a significant moderator of intervention effects (p=0.002) in which effects increased as baseline consumption increased. These results demonstrate the efficacy of a mobile app to increase vegetable consumption among overweight adults. Theory-based mobile interventions may present a low-cost, scalable, and effective approach to improving dietary behaviors and preventing associated chronic diseases. ClinicalTrials.gov NCT01826591. Registered 27 March 2013.

  12. Stopping randomized trials early for benefit: a protocol of the Study Of Trial Policy Of Interim Truncation-2 (STOPIT-2

    Directory of Open Access Journals (Sweden)

    Mullan Rebecca J

    2009-07-01

    Full Text Available Abstract Background Randomized clinical trials (RCTs stopped early for benefit often receive great attention and affect clinical practice, but pose interpretational challenges for clinicians, researchers, and policy makers. Because the decision to stop the trial may arise from catching the treatment effect at a random high, truncated RCTs (tRCTs may overestimate the true treatment effect. The Study Of Trial Policy Of Interim Truncation (STOPIT-1, which systematically reviewed the epidemiology and reporting quality of tRCTs, found that such trials are becoming more common, but that reporting of stopping rules and decisions were often deficient. Most importantly, treatment effects were often implausibly large and inversely related to the number of the events accrued. The aim of STOPIT-2 is to determine the magnitude and determinants of possible bias introduced by stopping RCTs early for benefit. Methods/Design We will use sensitive strategies to search for systematic reviews addressing the same clinical question as each of the tRCTs identified in STOPIT-1 and in a subsequent literature search. We will check all RCTs included in each systematic review to determine their similarity to the index tRCT in terms of participants, interventions, and outcome definition, and conduct new meta-analyses addressing the outcome that led to early termination of the tRCT. For each pair of tRCT and systematic review of corresponding non-tRCTs we will estimate the ratio of relative risks, and hence estimate the degree of bias. We will use hierarchical multivariable regression to determine the factors associated with the magnitude of this ratio. Factors explored will include the presence and quality of a stopping rule, the methodological quality of the trials, and the number of total events that had occurred at the time of truncation. Finally, we will evaluate whether Bayesian methods using conservative informative priors to "regress to the mean" overoptimistic t

  13. Acupuncture Improves Peri-menopausal Insomnia: A Randomized Controlled Trial.

    Science.gov (United States)

    Fu, Cong; Zhao, Na; Liu, Zhen; Yuan, Lu-Hua; Xie, Chen; Yang, Wen-Jia; Yu, Xin-Tong; Yu, Huan; Chen, Yun-Fei

    2017-11-01

    To evaluate the short-term efficacy of acupuncture for the treatment of peri-menopausal insomnia (PMI). Design: A randomized, participant-blind, placebo-controlled trial consisted of the acupuncture group (n = 38) and placebo-acupuncture group (n = 38). Setting: A tertiary teaching and general hospital. Participants: 76 peri-menopausal women with insomnia disorder based on the International Classification of Sleep Disorders, Third Edition. Interventions: A 10-session of acupuncture at bilateral Shenshu (BL 23) and Ganshu (BL 18) with unilateral Qimen (LR 14) and Jingmen (GB 25) or Streitberger needles at the same acupoints was performed for over 3 weeks. Measurements: Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) with over-night polysomnography (PSG) exam were completed at baseline and post-treatment. After the treatments, the decrease from baseline in PSQI score was 8.03 points in acupuncture group and 1.29 points in placebo-acupuncture group. The change from baseline in ISI score was 11.35 points in acupuncture group and 2.87 points in placebo-acupuncture group. In PSG data, acupuncture significantly improved the sleep efficiency and total sleep time, associated with less wake after sleep onset and lower percent stage 1 after the treatment. No significant differences from baseline to post-treatment were found in placebo-acupuncture group. Acupuncture can contribute to a clinically relevant improvement in the short-term treatment of PMI, both subjectively and objectively. Acupuncture for peri-menopause insomnia: a randomized controlled trial, http://www.chictr.org.cn/showproj.aspx?proj=12118 ChiCTR-IPR-15007199, China.

  14. Computerized Tool to Manage Dental Anxiety: A Randomized Clinical Trial.

    Science.gov (United States)

    Tellez, M; Potter, C M; Kinner, D G; Jensen, D; Waldron, E; Heimberg, R G; Myers Virtue, S; Zhao, H; Ismail, A I

    2015-09-01

    Anxiety regarding dental and physical health is a common and potentially distressing problem, for both patients and health care providers. Anxiety has been identified as a barrier to regular dental visits and as an important target for enhancement of oral health-related quality of life. The study aimed to develop and evaluate a computerized cognitive-behavioral therapy dental anxiety intervention that could be easily implemented in dental health care settings. A cognitive-behavioral protocol based on psychoeducation, exposure to feared dental procedures, and cognitive restructuring was developed. A randomized controlled trial was conducted (N = 151) to test its efficacy. Consenting adult dental patients who met inclusion criteria (e.g., high dental anxiety) were randomized to 1 of 2 groups: immediate treatment (n = 74) or a wait-list control (n = 77). Analyses of covariance based on intention-to-treat analyses were used to compare the 2 groups on dental anxiety, fear, avoidance, and overall severity of dental phobia. Baseline scores on these outcomes were entered into the analyses as covariates. Groups were equivalent at baseline but differed at 1-mo follow-up. Both groups showed improvement in outcomes, but analyses of covariance demonstrated significant differences in dental anxiety, fear, avoidance, and overall severity of dental phobia in favor of immediate treatment at the follow-up assessment. Of the patients who met diagnostic criteria for phobia at baseline, fewer patients in the immediate treatment group continued to meet criteria for dental phobia at follow-up as compared with the wait-list group. A new computer-based tool seems to be efficacious in reducing dental anxiety and fear/avoidance of dental procedures. Examination of its effectiveness when administered in dental offices under less controlled conditions is warranted (ClinicalTrials.gov NCT02081365). © International & American Associations for Dental Research.

  15. Laparoscopic Versus Abdominal Sacrocolpopexy: A Randomized, Controlled Trial.

    Science.gov (United States)

    Costantini, Elisabetta; Mearini, Luigi; Lazzeri, Massimo; Bini, Vittorio; Nunzi, Elisabetta; di Biase, Manuel; Porena, Massimo

    2016-07-01

    Few randomized, controlled trials have compared standard abdominal sacrocolpopexy and the laparoscopic approach. We tested the hypothesis that laparoscopic sacrocolpopexy could compete with abdominal sacrocolpopexy for pelvic organ prolapse repair. This randomized, controlled trial was done to compare laparoscopic sacrocolpopexy and abdominal sacrocolpopexy for pelvic organ prolapse repair in women referred to our tertiary Department of Urology for symptomatic stage 2 or greater pelvic organ prolapse. The primary outcome was quantitative evaluation by the POP-Q (Pelvic Organ Prolapse Quantification) system. Cure was defined as prolapse stage 1 or less, point C/D -5 or less at the apex and at least 7 cm total vaginal length. Secondary outcomes were the complication rate, operative time, intraoperative blood loss, hospital stay and PGI-I (Patient Global Impression of Improvement) scores. The Kaplan-Meier estimator with the log-rank test was used to estimate pelvic organ prolapse recurrence-free survival rates. A total of 200 patients were eligible for study. We compared 60 and 61 patients treated with abdominal and laparoscopic sacrocolpopexy, respectively. At a mean followup of 41.7 months the cure rate was of 100% for both approaches. Kaplan-Meier curves showed that overall pelvic organ prolapse recurrence-free survival was longer following the open approach. Patients treated with laparoscopic sacrocolpopexy showed significantly earlier recurrence (p = 0.030), mostly in the first 12 months after surgery. When evaluating the different compartments, a statistically significant difference was observed between the laparoscopic and abdominal approaches for anterior compartment descensus (11 vs 1, p = 0.004). Statistical results had high internal validity but may not be applicable to other populations or settings. Laparoscopic sacrocolpopexy provides outcomes as good as those of abdominal sacrocolpopexy for anatomical correction but not for anterior pelvic organ prolapse

  16. Music intervention during daily weaning trials-A 6 day prospective randomized crossover trial.

    Science.gov (United States)

    Liang, Zhan; Ren, Dianxu; Choi, JiYeon; Happ, Mary Beth; Hravnak, Marylyn; Hoffman, Leslie A

    2016-12-01

    To examine the effect of patient-selected music intervention during daily weaning trials for patients on prolonged mechanical ventilation. Using a crossover repeated measures design, patients were randomized to music vs no music on the first intervention day. Provision of music was alternated for 6 days, resulting in 3 music and 3 no music days. During weaning trials on music days, data were obtained for 30min prior to music listening and continued for 60min while patients listened to selected music (total 90min). On no music days, data were collected for 90min. Outcome measures were heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), blood pressure (BP), dyspnea and anxiety assessed with a visual analog scale (VAS-D, VAS-A) and weaning duration (meanh per day on music and non-music days). Of 31 patients randomized, 23 completed the 6-day intervention. When comparisons were made between the 3 music and 3 no music days, there were significant decreases in RR and VAS-D and a significant increase in daily weaning duration on music days (pmusic days (pmusic during daily weaning trials is a simple, low-cost, potentially beneficial intervention for patients on prolonged mechanical ventilation. Further study is indicated to test ability of this intervention to promote weaning success and benefits earlier in the weaning process. Copyright © 2016 Elsevier Ltd. All rights reserved.

  17. Randomized trial of behavior therapy for adults with Tourette syndrome.

    Science.gov (United States)

    Wilhelm, Sabine; Peterson, Alan L; Piacentini, John; Woods, Douglas W; Deckersbach, Thilo; Sukhodolsky, Denis G; Chang, Susanna; Liu, Haibei; Dziura, James; Walkup, John T; Scahill, Lawrence

    2012-08-01

    Tics in Tourette syndrome begin in childhood, peak in early adolescence, and often decrease by early adulthood. However, some adult patients continue to have impairing tics. Medications for tics are often effective but can cause adverse effects. Behavior therapy may offer an alternative but has not been examined in a large-scale controlled trial in adults. To test the efficacy of a comprehensive behavioral intervention for tics in adults with Tourette syndrome of at least moderate severity. A randomized controlled trial with posttreatment evaluations at 3 and 6 months for positive responders. Three outpatient research clinics. Patients (N = 122; 78 males; age range, 16-69 years) with Tourette syndrome or chronic tic disorder were recruited between December 27, 2005, and May 21, 2009. Patients received 8 sessions of comprehensive behavioral intervention for tics or 8 sessions of supportive treatment for 10 weeks. Patients with a positive response were given 3 monthly booster sessions. Total tic score on the Yale Global Tic Severity Scale and the Clinical Global Impression-Improvement scale rated by a clinician masked to treatment assignment. Behavior therapy was associated with a significantly greater mean (SD) decrease on the Yale Global Tic Severity Scale (24.0 [6.47] to 17.8 [7.32]) from baseline to end point compared with the control treatment (21.8 [6.59] to 19.3 [7.40]) (P Tourette syndrome. clinicaltrials.gov Identifier: NCT00231985.

  18. Pediatric selective mutism therapy: a randomized controlled trial.

    Science.gov (United States)

    Esposito, Maria; Gimigliano, Francesca; Barillari, Maria R; Precenzano, Francesco; Ruberto, Maria; Sepe, Joseph; Barillari, Umberto; Gimigliano, Raffaele; Militerni, Roberto; Messina, Giovanni; Carotenuto, Marco

    2017-10-01

    Selective mutism (SM) is a rare disease in children coded by DSM-5 as an anxiety disorder. Despite the disabling nature of the disease, there is still no specific treatment. The aims of this study were to verify the efficacy of six-month standard psychomotor treatment and the positive changes in lifestyle, in a population of children affected by SM. Randomized controlled trial registered in the European Clinical Trials Registry (EuDract 2015-001161-36). University third level Centre (Child and Adolescent Neuropsychiatry Clinic). Study population was composed by 67 children in group A (psychomotricity treatment) (35 M, mean age 7.84±1.15) and 71 children in group B (behavioral and educational counseling) (37 M, mean age 7.75±1.36). Psychomotor treatment was administered by trained child therapists in residential settings three times per week. Each child was treated for the whole period by the same therapist and all the therapists shared the same protocol. The standard psychomotor session length is of 45 minutes. At T0 and after 6 months (T1) of treatments, patients underwent a behavioral and SM severity assessment. To verify the effects of the psychomotor management, the Child Behavior Checklist questionnaire (CBCL) and Selective Mutism Questionnaire (SMQ) were administered to the parents. After 6 months of psychomotor treatment SM children showed a significant reduction among CBCL scores such as in social relations, anxious/depressed, social problems and total problems (Ppsychomotricity a safe and efficacy therapy for pediatric selective mutism.

  19. Quality of reporting randomized controlled trials in cancer nursing research.

    Science.gov (United States)

    Guo, Jia-Wen; Sward, Katherine A; Beck, Susan L; Staggers, Nancy

    2014-01-01

    Results of randomized controlled trials (RCTs) provide high-level evidence for evidence-based practice (EBP). The quality of RCTs has a substantial influence on providing reliable knowledge for EBP. Little is known about the quality of RCT reporting in cancer nursing. The aim of this study was to assess the quality of reporting in published cancer nursing RCTs from 1984 to 2010. A total of 227 RCTs in cancer nursing published in English-language journals and indexed in PubMed or Cumulative Index to Nursing and Allied Health Literature were reviewed using the Jadad scale, key methodologic index (KMI), and the Consolidated Standards of Reporting Trials (CONSORT) checklist to assess the quality of reporting methodological aspects of research and the overall quality of reporting RCTs. Adherence to reporting metrics was relatively low, based on the Jadad score (M = 1.94 out of 5, SD = 1.01), KMI scores (M = 0.84 out of 3, SD = .87), and adherence to CONSORT checklist items (M =16.92 out of 37, SD = 4.03). Only 11 of 37 items in the CONSORT checklist were reported in 80% or more of the studies reviewed. The quality of reporting showed some improvement over time. Adherence to reporting metrics for cancer nursing RCTs was suboptimal, and further efforts are needed to improve both methodology reporting and overall reporting. Journals are encouraged to adopt the CONSORT checklist to influence the quality of RCT reports.

  20. How pragmatic or explanatory is the randomized, controlled trial? The application and enhancement of the PRECIS tool to the evaluation of a smoking cessation trial

    Directory of Open Access Journals (Sweden)

    Selby Peter

    2012-07-01

    Full Text Available Abstract Background Numerous explanatory randomized trials support the efficacy of chronic disease interventions, including smoking cessation treatments. However, there is often inadequate adoption of these interventions for various reasons, one being the limitation of generalizability of the explanatory studies in real-world settings. Randomized controlled trials can be rated as more explanatory versus pragmatic along 10 dimensions. Pragmatic randomized clinical trials generate more realistic estimates of effectiveness with greater relevance to clinical practice and for health resource allocation decisions. However, there is no clear method to scale each dimension during the trial design phase to ensure that the design matches the intended purpose of the study. Methods We designed a pragmatic, randomized, controlled study to maximize external validity by addressing several barriers to smoking cessation therapy in ambulatory care. We analyzed our design and methods using the recently published ‘Pragmatic–Explanatory Continuum Indicatory Summary (PRECIS’ tool, a qualitative method to assess trial design across 10 domains. We added a 20-point numerical rating scale and a modified Delphi process to improve consensus in rating these domains. Results After two rounds of review, there was consensus on all 10 domains of study design. No single domain was scored as either fully pragmatic or fully explanatory; but overall, the study scored high on pragmatism. Conclusions This addition to the PRECIS tool may assist other trial designers working with interdisciplinary co-investigators to rate their study design while building consensus.

  1. A multicenter, randomized, controlled trial of dexamethasone for bronchiolitis.

    Science.gov (United States)

    Corneli, Howard M; Zorc, Joseph J; Mahajan, Prashant; Majahan, Prashant; Shaw, Kathy N; Holubkov, Richard; Reeves, Scott D; Ruddy, Richard M; Malik, Baqir; Nelson, Kyle A; Bregstein, Joan S; Brown, Kathleen M; Denenberg, Matthew N; Lillis, Kathleen A; Cimpello, Lynn Babcock; Tsung, James W; Borgialli, Dominic A; Baskin, Marc N; Teshome, Getachew; Goldstein, Mitchell A; Monroe, David; Dean, J Michael; Kuppermann, Nathan

    2007-07-26

    Bronchiolitis, the most common infection of the lower respiratory tract in infants, is a leading cause of hospitalization in childhood. Corticosteroids are commonly used to treat bronchiolitis, but evidence of their effectiveness is limited. We conducted a double-blind, randomized trial comparing a single dose of oral dexamethasone (1 mg per kilogram of body weight) with placebo in 600 children (age range, 2 to 12 months) with a first episode of wheezing diagnosed in the emergency department as moderate-to-severe bronchiolitis (defined by a Respiratory Distress Assessment Instrument score > or =6). We enrolled patients at 20 emergency departments during the months of November through April over a 3-year period. The primary outcome was hospital admission after 4 hours of emergency department observation. The secondary outcome was the Respiratory Assessment Change Score (RACS). We also evaluated later outcomes: length of hospital stay, later medical visits or admissions, and adverse events. Baseline characteristics were similar in the two groups. The admission rate was 39.7% for children assigned to dexamethasone, as compared with 41.0% for those assigned to placebo (absolute difference, -1.3%; 95% confidence interval [CI], -9.2 to 6.5). Both groups had respiratory improvement during observation; the mean 4-hour RACS was -5.3 for dexamethasone, as compared with -4.8 for placebo (absolute difference, -0.5; 95% CI, -1.3 to 0.3). Multivariate adjustment did not significantly alter the results, nor were differences detected in later outcomes. In infants with acute moderate-to-severe bronchiolitis who were treated in the emergency department, a single dose of 1 mg of oral dexamethasone per kilogram did not significantly alter the rate of hospital admission, the respiratory status after 4 hours of observation, or later outcomes. (ClinicalTrials.gov number, NCT00119002 [ClinicalTrials.gov].). Copyright 2007 Massachusetts Medical Society.

  2. Teaching Children to Cross Streets Safely: A Randomized Controlled Trial

    Science.gov (United States)

    Schwebel, David C.; McClure, Leslie A.; Severson, Joan

    2014-01-01

    Objective Child pedestrian injury is a global public health challenge. This randomized controlled trial considered comparative efficacy of individualized streetside training, training in a virtual pedestrian environment, training using videos and websites, plus no-training control, to improve children’s street-crossing ability. Methods Pedestrian safety was evaluated among 231 seven- and eight-year-olds using both streetside (field) and laboratory-based (virtual environment) trials prior to intervention group assignment, immediately post-training, and six months post-training. All training groups received six 30-minute sessions. Four outcomes assessed pedestrian safety: start delay (temporal lag before initiating crossing), hits/close calls (collisions/near-misses with vehicles in simulated crossings), attention to traffic (looks left and right, controlled for time), and missed opportunities (safe crossing opportunities that were missed). Results Results showed training in the virtual pedestrian environment and especially individualized streetside training resulted in safer pedestrian behavior post-intervention and at follow-up. As examples, children trained streetside entered safe traffic gaps more quickly post-training than control group children and children trained streetside or in the virtual environment had somewhat fewer hits/close calls in post-intervention VR trials. Children showed minimal change in attention to traffic post-training. Children trained with videos/websites showed minimal learning. Conclusion Both individualized streetside training and training within virtual pedestrian environments may improve 7- and 8-year-olds’ street-crossing safety. Individualized training has limitations of adult time and labor. Virtual environment training has limitations of accessibility and cost. Given the public health burden of child pedestrian injuries, future research should explore innovative strategies for effective training that can be broadly

  3. Botulinum toxin therapy for temporomandibular joint disorders: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Chen, Y-W; Chiu, Y-W; Chen, C-Y; Chuang, S-K

    2015-08-01

    The objective of this study was to undertake a systematic review to assess the efficacy of botulinum toxin therapy (BTX) for temporomandibular joint disorders (TMDs). A comprehensive search of major databases through PubMed, EMBASE, and Cochrane CENTRAL was conducted to locate all relevant articles published from inception to October 2014. Eligible studies were selected based on inclusion criteria and included English language, peer-reviewed publications of randomized controlled trials comparing BTX versus any alternative intervention or placebo. Quality assessment and data extraction were done according to the Cochrane risk of bias tool and recommendations. The entire systematic search and selection process was done independently by two reviewers. Five relevant study trials were identified, involving 117 participants. Two trials revealed a significant between-group difference in myofascial pain reduction, another trial that compared BTX with fascial manipulation showed equal efficacy of pain relief on TMDs, while the remaining two trials showed no significant difference between the BTX and placebo groups. Because of considerable variations in study methods and evaluation of results, a meta-analysis could not be performed. Based on this review, no consensus could be reached on the therapeutic benefits of BTX on TMDs. A more rigorous design of trials should be carried out in future studies. Copyright © 2015 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  4. Multiple micronutrient supplementation for improving cognitive performance in children: systematic review of randomized controlled trials.

    Science.gov (United States)

    Eilander, Ans; Gera, Tarun; Sachdev, Harshpal S; Transler, Catherine; van der Knaap, Henk Cm; Kok, Frans J; Osendarp, Saskia Jm

    2010-01-01

    Although multiple micronutrient interventions have been shown to benefit children's intellectual development, a thorough evaluation of the totality of evidence is currently lacking to direct public health policy. This study aimed to systematically review the present literature and to quantify the effect of multiple micronutrients on cognitive performance in schoolchildren. The Institute for Scientific Information Web of Knowledge and local medical databases were searched for trials published from 1970 to 2008. Randomized controlled trials that investigated the effect of > or =3 micronutrients compared with placebo on cognition in healthy children aged 0-18 y were included following protocol. Data were extracted by 2 independent researchers. The cognitive tests used in the trials were grouped into several cognitive domains (eg, fluid and crystallized intelligence), and pooled effect size estimates were calculated per domain. Heterogeneity was explored through sensitivity and meta-regression techniques. Three trials were retrieved in children aged intelligence and -0.03 SD (95% CI: -0.21, 0.15; P = 0.74) for crystallized intelligence, both of which were based on 12 trials. Four trials yielded an overall effect of 0.30 SD (95% CI: 0.01, 0.58; P = 0.044) for academic performance. For other cognitive domains, no significant effects were found. Multiple micronutrient supplementation may be associated with a marginal increase in fluid intelligence and academic performance in healthy schoolchildren but not with crystallized intelligence. More research is required, however, before public health recommendations can be given.

  5. Amantadine for Antipsychotic-Related Weight Gain: Meta-Analysis of Randomized Placebo-Controlled Trials.

    Science.gov (United States)

    Zheng, Wei; Wang, Shibin; Ungvari, Gabor S; Ng, Chee H; Yang, Xin-Hu; Gu, Yu-Hong; Li, Ming; Xiang, Ying-Qiang; Xiang, Yu-Tao

    2017-06-01

    Weight gain associated with antipsychotics in schizophrenia has been an ongoing concern. This meta-analysis examined the efficacy and safety of amantadine as an adjunctive treatment of weight gain in schizophrenia by systematically searching and analyzing randomized controlled trials (RCTs). RCTs comparing adjunctive amantadine with placebo in adult patients with schizophrenia were included in the meta-analysis. Two independent investigators searched the literature and extracted data. Weighted and standardized mean differences (WMDs/SMDs) and risk ratio ± 95% confidence intervals were calculated. Five RCTs (n = 265) with double-blinded design lasting 8.2 ± 5.9 weeks were included in the analysis. Amantadine outperformed placebo regarding weight reduction with moderate effect size (trials, 3; n = 205; WMD -2.22 kg; P = 0.001, I = 45%). Amantadine also outperformed placebo at endpoint in the negative symptom (the Positive and Negative Syndrome Scale [PANSS] [1 trial] and the Scale for the Assessment of Negative Symptoms [1 trial]) scores (trials, 2; n = 84; SMD, -0.56; P = 0.01, I = 12%), but not in the PANSS total scores (trials, 2) (SMD, -0.31; P = 0.16, I = 0%) and the positive symptom (PANSS [1 trial] and the Scale for the Assessment of Positive Symptoms [1 trial]) scores (SMD, 0.13; P = 0.54, I = 0%). Except for insomnia (P = 0.007; number needed to harm, 6; 95% confidence interval, 4-16), all-cause discontinuation (risk ratio, 1.12; P = 0.54, I = 0%) and other adverse events were similar between the amantadine and placebo groups. According to this meta-analysis of 5 RCTs, adjunctive amantadine seems to be an effective option for attenuating antipsychotic-related weight gain in patients with schizophrenia. More RCTs are needed to inform clinical recommendations.

  6. A randomized, controlled clinical trial: the effect of mindfulness-based cognitive therapy on generalized anxiety disorder among Chinese community patients: protocol for a randomized trial.

    Science.gov (United States)

    Wong, Samuel Y S; Mak, Winnie W S; Cheung, Eliza Y L; Ling, Candy Y M; Lui, Wacy W S; Tang, W K; Wong, Rebecca L P; Lo, Herman H M; Mercer, Stewart; Ma, Helen S W

    2011-11-29

    Research suggests that an eight-week Mindfulness-Based Cognitive Therapy (MBCT) program may be effective in the treatment of generalized anxiety disorders. Our objective is to compare the clinical effectiveness of the MBCT program with a psycho-education programme and usual care in reducing anxiety symptoms in people suffering from generalized anxiety disorder. A three armed randomized, controlled clinical trial including 9-month post-treatment follow-up is proposed. Participants screened positive using the Structure Clinical Interview for DSM-IV (SCID) for general anxiety disorder will be recruited from community-based clinics. 228 participants will be randomly allocated to the MBCT program plus usual care, psycho-education program plus usual care or the usual care group. Validated Chinese version of instruments measuring anxiety and worry symptoms, depression, quality of life and health service utilization will be used. Our primary end point is the change of anxiety and worry score (Beck Anxiety Inventory and Penn State Worry Scale) from baseline to the end of intervention. For primary analyses, treatment outcomes will be assessed by ANCOVA, with change in anxiety score as the baseline variable, while the baseline anxiety score and other baseline characteristics that significantly differ between groups will serve as covariates. This is a first randomized controlled trial that compare the effectiveness of MBCT with an active control, findings will advance current knowledge in the management of GAD and the way that group intervention can be delivered and inform future research. Unique Trail Number (assigned by Centre for Clinical Trails, Clinical Trials registry, The Chinese University of Hong Kong): CUHK_CCT00267.

  7. A randomized, controlled clinical trial: the effect of mindfulness-based cognitive therapy on generalized anxiety disorder among Chinese community patients: protocol for a randomized trial

    Directory of Open Access Journals (Sweden)

    Wong Samuel YS

    2011-11-01

    Full Text Available Abstract Background Research suggests that an eight-week Mindfulness-Based Cognitive Therapy (MBCT program may be effective in the treatment of generalized anxiety disorders. Our objective is to compare the clinical effectiveness of the MBCT program with a psycho-education programme and usual care in reducing anxiety symptoms in people suffering from generalized anxiety disorder. Methods A three armed randomized, controlled clinical trial including 9-month post-treatment follow-up is proposed. Participants screened positive using the Structure Clinical Interview for DSM-IV (SCID for general anxiety disorder will be recruited from community-based clinics. 228 participants will be randomly allocated to the MBCT program plus usual care, psycho-education program plus usual care or the usual care group. Validated Chinese version of instruments measuring anxiety and worry symptoms, depression, quality of life and health service utilization will be used. Our primary end point is the change of anxiety and worry score (Beck Anxiety Inventory and Penn State Worry Scale from baseline to the end of intervention. For primary analyses, treatment outcomes will be assessed by ANCOVA, with change in anxiety score as the baseline variable, while the baseline anxiety score and other baseline characteristics that significantly differ between groups will serve as covariates. Conclusions This is a first randomized controlled trial that compare the effectiveness of MBCT with an active control, findings will advance current knowledge in the management of GAD and the way that group intervention can be delivered and inform future research. Unique Trail Number (assigned by Centre for Clinical Trails, Clinical Trials registry, The Chinese University of Hong Kong: CUHK_CCT00267

  8. The treatment of medial tibial stress syndrome in athletes; a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Moen Maarten

    2012-03-01

    Full Text Available Abstract Background The only three randomized trials on the treatment of MTSS were all performed in military populations. The treatment options investigated in this study were not previously examined in athletes. This study investigated if functional outcome of three common treatment options for medial tibial stress syndrome (MTSS in athletes in a non-military setting was the same. Methods The study design was randomized and multi-centered. Physical therapists and sports physicians referred athletes with MTSS to the hospital for inclusion. 81 athletes were assessed for eligibility of which 74 athletes were included and randomized to three treatment groups. Group one performed a graded running program, group two performed a graded running program with additional stretching and strengthening exercises for the calves, while group three performed a graded running program with an additional sports compression stocking. The primary outcome measure was: time to complete a running program (able to run 18 minutes with high intensity and secondary outcome was: general satisfaction with treatment. Results 74 Athletes were randomized and included of which 14 did not complete the study due a lack of progress (18.9%. The data was analyzed on an intention-to-treat basis. Time to complete a running program and general satisfaction with the treatment were not significantly different between the three treatment groups. Conclusion This was the first randomized trial on the treatment of MTSS in athletes in a non-military setting. No differences were found between the groups for the time to complete a running program. Trial registration CCMO; NL23471.098.08

  9. Mindfulness vs psychoeducation in adult ADHD: a randomized controlled trial.

    Science.gov (United States)

    Hoxhaj, E; Sadohara, C; Borel, P; D'Amelio, R; Sobanski, E; Müller, H; Feige, B; Matthies, S; Philipsen, Alexandra

    2018-01-22

    Mindfulness training is a promising treatment approach in adult ADHD. However, there has not yet been a randomized controlled trial comparing mindfulness to an active control condition. In this study, we assessed the efficacy of a mindfulness training program (MAP) compared to structured psychoeducation (PE). After randomization 81 medication-free adult ADHD patients participated either in an 8-week MAP or PE group program. At baseline (T1), after 8 weeks (T2) and after 8 months (T3), severity of ADHD and associated symptoms (depression, general psychopathology, quality of life) were measured with the Conner's ADHD Rating Scales (CAARS), the Beck Depression Inventory (BDI), the Brief Symptom Inventory (BSI) and the SF-36 by self and blind observer ratings. Both groups showed significant pre-post improvements in observer-rated Inattention scale (p load in adult ADHD. Furthermore in exploratory post hoc tests the study provides evidence for a potential gender-specific treatment response in adult ADHD.

  10. A randomized controlled trial of home tooth-whitening products.

    Science.gov (United States)

    Lo, Edward C M; Wong, Anthony H H; McGrath, Colman

    2007-10-01

    To evaluate the effectiveness of two marketed home tooth-whitening products. A randomized controlled clinical trial involving 87 adults who were randomly allocated into one of three groups: (1) 6% hydrogen peroxide whitening strips, (2) 18% carbamide peroxide whitening gel, and (3) a placebo (fluoride toothpaste) control group. Subjects were instructed individually and then used the given product daily for 2 consecutive weeks. Color was determined in brightness (L*), yellowness (b*) and redness (a*) [color space] at baseline and 8 weeks after dispensing the product by employing a high resolution digital camera (Fuji HC1000 CCD) to image the subject's anterior maxillary teeth under standard polarized lighting conditions. The subjects also completed a questionnaire on self-satisfaction with the treatment outcome. One-way ANOVA (Bonferroni test) demonstrated significant differences in color between the three groups with changes in brightness (L*, Pwhitening strips. Subjects in the whitening strip group also rated that product significantly (P whitening satisfaction and overall impression while there is no significant difference between the whitening gel and the placebo groups.

  11. Effects of professional oral health care on elderly: randomized trial.

    Science.gov (United States)

    Morino, T; Ookawa, K; Haruta, N; Hagiwara, Y; Seki, M

    2014-11-01

    To better understand the role of the professional oral health care for elderly in improving geriatric oral health, the effects of short-term professional oral health care (once per week for 1 month) on oral microbiological parameters were assessed. Parallel, open-labelled, randomize-controlled trial was undertaken in a nursing home for elderly in Shizuoka, Japan. Thirty-four dentate elderly over 74 years were randomly assigned from ID number to the intervention (17/34) and control (17/34) groups. The outcomes were changes in oral microbiological parameters (number of bacteria in unstimulated saliva; whole bacteria, Streptococcus, Fusobacterium and Prevotella: opportunistic pathogens detection: and index of oral hygiene evaluation [Dental Plaque Index, DPI]) within the intervention period. Each parameter was evaluated at before and after intervention period. Four elderly were lost from mortality (1), bone fracture (1), refused to participate (1) and multi-antibiotics usage (1). Finally, 30 elderly were analysed (14/intervention and 16/control). At baseline, no difference was found between the control and intervention groups. After the intervention period, the percentage of Streptococcus species increased significantly in the intervention group (Intervention, 86% [12/14]; Control, 50% [8/16]: Fisher's, right-tailed, P oral health care can improve oral conditions in the elderly. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  12. Metoclopramide to augment lactation, does it work? A randomized trial.

    Science.gov (United States)

    Fife, Shannon; Gill, Prabhcharan; Hopkins, Michael; Angello, Carol; Boswell, Sue; Nelson, Karl M

    2011-11-01

    The objective of this study was to investigate the efficacy of metoclopramide on augmentation of milk production in mothers of premature newborns. This was a randomized, double-blind, placebo-controlled trial. Women who delivered at ≤34 weeks of gestation, with no prior breastfeeding experience, singleton pregnancy, and no contraindications to using metoclopramide were eligible for entry. Twenty-five women were randomly assigned to receive 10 mg of metoclopramide or placebo three times daily for 8 days starting within 36 h of birth. Certified lactation nurses provided breastfeeding education. Breast milk expressed at each pumping session over the 8 days of treatment was recorded. Data from 18 patients were available for analysis. Milk production in both groups increased rapidly during the first 4 days and then more gradually to an average for the last 4 days of 633 ± 168 (9) ml/day [mean ± SEM (n)] for the placebo group and 459 ± 91 (10) ml/day for the metoclopramide group. Analysis with a repeated-measures ANOVA indicated a significant increase in milk production during the 8-day measurement period [within subjects p power for detection of 50% difference) the breast milk production. Maternal interest, education, and support are recognized as mainstay in accomplishing successful lactation.

  13. Nebulized Magnesium Sulfate in Acute Bronchiolitis: A Randomized Controlled Trial.

    Science.gov (United States)

    Modaresi, Mohammad Reza; Faghihinia, Jamal; Kelishadi, Roya; Reisi, Mohsen; Mirlohi, Shahrokh; Pajhang, Farhad; Sadeghian, Majid

    2015-09-01

    To assess the efficacy of nebulized magnesium sulfate as a bronchodilator in infants hospitalized with acute bronchiolitis. This three-center double masked randomized clinical trial comprised 120 children with moderate to severe bronchiolitis. They were randomly assigned into two groups: the first group was treated with nebulized magnesium sulfate (40 mg/kg) and nebulized epinephrine (0.1 ml/kg) and the second group (control) was treated with nebulized epinephrine (0.1 ml/kg). The primary outcome was the length of hospital stay. The use of oxygen, temperature, oxygen saturation (SPO2), pulse rate (PR), respiratory rate (RR) and respiratory distress assessment instrument (RDAI) score were measured in the beginning of the study and during hospitalization. The mean (SD) age of 120 infants was 5.1(± 2.6) mo and 60% were boys. The length of hospital stay was not different between the two groups (P > 0.01). Use of oxygen supplementation, SPO2 and vital signs were similar in the two groups. Improvement in RDAI score was significantly better in infants treated with nebulized magnesium sulfate than in the other group (P 0.01). Thus, in infants with acute bronchiolitis, the effect of nebulized magnesium sulfate is comparable to nebulized epinephrine. However nebulized magnesium sulfate can improve the clinical score so it may have additive effect to reduce symptoms during hospitalization.

  14. The effectiveness of propolis on gingivitis: a randomized controlled trial.

    Science.gov (United States)

    Bretz, Walter A; Paulino, Niraldo; Nör, Jacques E; Moreira, Alexandre

    2014-12-01

    A randomized, double-blind, controlled clinical trial was conducted to evaluate the effectiveness of a propolis rinse on induced gingivitis by using the co-twin study design. Twenty-one twin pairs (n=42) were enrolled in a gingivitis study with oral hygiene promotion (14 days) and gingivitis induction (21 days). During the gingivitis induction phase, one member of the twin pair was randomly assigned to a 2% typified propolis rinse, and the other was assigned a color-matched 0.05% sodium fluoride plus 0.05% cetylpyridinium chloride rinse (positive control). Patients rinsed twice daily with 20 mL for 30 seconds for 21 days. Gingivitis was measured on days -14 (baseline), 0 (after hygiene phase), and 21 (after no-hygiene phase) by using the Papillary Bleeding Score (PBS) and by standard digital imaging of the gum tissues (G-parameter). The 38 persons who completed the study (age 13-22 years) were well balanced according to PBS at baseline and G-parameter after the initial hygiene phase. After 21 days without oral hygiene, the propolis rinse and positive control rinse groups did not differ significantly for average PBS measurements or G-parameter. Use of a 2% typified propolis rinse was equivalent to a positive control rinse during a 21-day no-hygiene period.

  15. Randomized trial of aromatherapy. Successful treatment for alopecia areata.

    Science.gov (United States)

    Hay, I C; Jamieson, M; Ormerod, A D

    1998-11-01

    To investigate the efficacy of aromatherapy in the treatment of patients with alopecia areata. A randomized, double-blind, controlled trial of 7 months' duration, with follow-up at 3 and 7 months. Dermatology outpatient department. Eighty-six patients diagnosed as having alopecia areata. Eighty-six patients were randomized into 2 groups. The active group massaged essential oils (thyme, rosemary, lavender, and cedarwood) in a mixture of carrier oils (jojoba and grapeseed) into their scalp daily. The control group used only carrier oils for their massage, also daily. Treatment success was evaluated on sequential photographs by 2 dermatologists (I.C.H. and A.D.O.) independently. Similarly, the degree of improvement was measured by 2 methods: a 6-point scale and computerized analysis of traced areas of alopecia. Nineteen (44%) of 43 patients in the active group showed improvement compared with 6 (15%) of 41 patients in the control group (P = .008). An alopecia scale was applied by blinded observers on sequential photographs and was shown to be reproducible with good interobserver agreement (kappa = 0.84). The degree of improvement on photographic assessment was significant (P = .05). Demographic analysis showed that the 2 groups were well matched for prognostic factors. The results show aromatherapy to be a safe and effective treatment for alopecia areata. Treatment with these essential oils was significantly more effective than treatment with the carrier oil alone (P = .008 for the primary outcome measure). We also successfully applied an evidence-based method to an alternative therapy.

  16. Resin infiltration of caries lesions: an efficacy randomized trial.

    Science.gov (United States)

    Paris, S; Hopfenmuller, W; Meyer-Lueckel, H

    2010-08-01

    Resin infiltration is an innovative approach to arrest progression of caries lesions. The aim of this randomized split-mouth placebo-controlled clinical trial was to assess whether resin infiltration of proximal lesions is more effective than non-operative measures alone with respect to the inhibition of caries progression. In 22 young adults, 29 pairs of interproximal lesions with radiological extension into the inner half of enamel or the outer third of dentin were randomly allocated to two treatment groups. In the test group, lesions were infiltrated (Icon, pre-product; DMG). A placebo treatment was performed in the control group. All participants received instructions for diet, flossing, and fluoridation. The primary outcome after 18 months was radiographic lesion progression (assessed by digital subtraction radiography). No unwanted effects could be observed. In the effect group, 2/27 lesions (7%) and in the control group 10/27 lesions (37%) showed progression (p = 0.021; McNemar). Infiltration of interproximal caries lesions is efficacious in reducing lesion progression.

  17. Effects of auriculotherapy on labour pain: a randomized clinical trial.

    Science.gov (United States)

    Mafetoni, Reginaldo Roque; Shimo, Antonieta Keiko Kakuda

    2016-01-01

    Assessing the effects of auriculotherapy in pain control and its outcomes on the duration of labour. This is a randomized, controlled, double-blind trial with preliminary data. Thirty pregnant women with gestational age ≥ 37 weeks, cervical dilatation ≥ 4 cm and two or more contractions in 10 minutes were selected and randomly divided into three groups: auriculotherapy, placebo and control. Auriculotherapy was applied using crystal beads on four strategic points. No statistical significance was found between the groups with regard to pain; however, the women from the auriculotherapy group had lower intensity and less perception of pain at 30, 60 and 120 minutes of treatment. The average duration of labour was shorter in the auriculotherapy group (248.7 versus placebo 414.8 versus control 296.3 minutes); caesarean section rates were higher in the placebo group (50%) and the same in the other groups (10%). Mothers who received auriculotherapy presented a tendency for greater pain control and shorter labour duration; however, caesarean section rates in this group were similar to the control group. This trial precedes a larger study in progress. Registration of Brazilian Clinical Trials: RBR-47hhbj. Avaliar os efeitos da auriculoterapia no controle da dor e seus desfechos na duração do trabalho de parto. Trata-se de um ensaio controlado, randomizado e duplo-cego, com dados preliminares. Foram selecionadas 30 parturientes com idade gestacional ≥ 37 semanas, dilatação cervical ≥ 4 cm e duas ou mais contrações em 10 minutos, divididas aleatoriamente em três grupos: auriculoterapia, placebo ou controle. A auriculoterapia foi aplicada com microesferas de cristais em quatro pontos estratégicos. Não houve significância estatística entre os grupos com relação à dor; no entanto, as mulheres do grupo de auriculoterapia, apresentaram menor intensidade e menor percepção da dor aos 30, 60 e 120 minutos do tratamento. A média de duração do trabalho de

  18. Empirical Evidence of Study Design Biases in Randomized Trials: Systematic Review of Meta-Epidemiological Studies.

    Directory of Open Access Journals (Sweden)

    Matthew J Page

    Full Text Available To synthesise evidence on the average bias and heterogeneity associated with reported methodological features of randomized trials.Systematic review of meta-epidemiological studies.We retrieved eligible studies included in a recent AHRQ-EPC review on this topic (latest search September 2012, and searched Ovid MEDLINE and Ovid EMBASE for studies indexed from Jan 2012-May 2015. Data were extracted by one author and verified by another. We combined estimates of average bias (e.g. ratio of odds ratios (ROR or difference in standardised mean differences (dSMD in meta-analyses using the random-effects model. Analyses were stratified by type of outcome ("mortality" versus "other objective" versus "subjective". Direction of effect was standardised so that ROR < 1 and dSMD < 0 denotes a larger intervention effect estimate in trials with an inadequate or unclear (versus adequate characteristic.We included 24 studies. The available evidence suggests that intervention effect estimates may be exaggerated in trials with inadequate/unclear (versus adequate sequence generation (ROR 0.93, 95% CI 0.86 to 0.99; 7 studies and allocation concealment (ROR 0.90, 95% CI 0.84 to 0.97; 7 studies. For these characteristics, the average bias appeared to be larger in trials of subjective outcomes compared with other objective outcomes. Also, intervention effects for subjective outcomes appear to be exaggerated in trials with lack of/unclear blinding of participants (versus blinding (dSMD -0.37, 95% CI -0.77 to 0.04; 2 studies, lack of/unclear blinding of outcome assessors (ROR 0.64, 95% CI 0.43 to 0.96; 1 study and lack of/unclear double blinding (ROR 0.77, 95% CI 0.61 to 0.93; 1 study. The influence of other characteristics (e.g. unblinded trial personnel, attrition is unclear.Certain characteristics of randomized trials may exaggerate intervention effect estimates. The average bias appears to be greatest in trials of subjective outcomes. More research on several

  19. Ghana randomized air pollution and health study (GRAPHS): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Jack, Darby W; Asante, Kwaku Poku; Wylie, Blair J; Chillrud, Steve N; Whyatt, Robin M; Ae-Ngibise, Kenneth A; Quinn, Ashlinn K; Yawson, Abena Konadu; Boamah, Ellen Abrafi; Agyei, Oscar; Mujtaba, Mohammed; Kaali, Seyram; Kinney, Patrick; Owusu-Agyei, Seth

    2015-09-22

    Household air pollution exposure is a major health risk, but validated interventions remain elusive. The Ghana Randomized Air Pollution and Health Study (GRAPHS) is a cluster-randomized trial that evaluates the efficacy of clean fuels (liquefied petroleum gas, or LPG) and efficient biomass cookstoves in the Brong-Ahafo region of central Ghana. We recruit pregnant women into LPG, efficient cookstove, and control arms and track birth weight and physician-assessed severe pneumonia incidence in the first year of life. A woman is eligible to participate if she is in the first or second trimester of pregnancy and carrying a live singleton fetus, if she is the primary cook, and if she does not smoke. We hypothesize that babies born to intervention mothers will weigh more and will have fewer cases of physician-assessed severe pneumonia in the first year of life. Additionally, an extensive personal air pollution exposure monitoring effort opens the way for exposure-response analyses, which we will present alongside intention-to-treat analyses. Major funding was provided by the National Institute of Environmental Health Sciences, The Thrasher Research Fund, and the Global Alliance for Clean Cookstoves. Household air pollution exposure is a major health risk that requires well-tested interventions. GRAPHS will provide important new evidence on the efficacy of both efficient biomass cookstoves and LPG, and will thus help inform health and energy policies in developing countries. The trial was registered with clinicaltrials.gov on 13 April 2011 with the identifier NCT01335490 .

  20. Screening for obstructive sleep apnea on the internet: randomized trial.

    Science.gov (United States)

    Hwang, Kevin O; Hamadah, Abdurrahman M; Johnson, Craig W; Thomas, Eric J; Goodrick, G Ken; Bernstam, Elmer V

    2009-10-01

    Obstructive sleep apnea is underdiagnosed. We conducted a pilot randomized controlled trial of an online intervention to promote obstructive sleep apnea screening among members of an Internet weight-loss community. Members of an Internet weight-loss community who have never been diagnosed with obstructive sleep apnea or discussed the condition with their healthcare provider were randomized to intervention (online risk assessment+feedback) or control. The primary outcome was discussing obstructive sleep apnea with a healthcare provider at 12 weeks. Of 4700 members who were sent e-mail study announcements, 168 (97% were female, age 39.5 years [standard deviation 11.7], body mass index 30.3 [standard deviation 7.8]) were randomized to intervention (n=84) or control (n=84). Of 82 intervention subjects who completed the risk assessment, 50 (61%) were low risk and 32 (39%) were high risk for obstructive sleep apnea. Intervention subjects were more likely than control subjects to discuss obstructive sleep apnea with their healthcare provider within 12 weeks (11% [9/84] vs 2% [2/84]; P=.02; relative risk=4.50; 95% confidence interval, 1.002-20.21). The number needed to treat was 12. High-risk intervention subjects were more likely than control subjects to discuss obstructive sleep apnea with their healthcare provider (19% [6/32] vs 2% [2/84]; P=.004; relative risk=7.88; 95% confidence interval, 1.68-37.02). One high-risk intervention subject started treatment for obstructive sleep apnea. An online screening intervention is feasible and likely effective in encouraging members of an Internet weight-loss community to discuss obstructive sleep apnea with their healthcare provider.

  1. Exergaming and older adult cognition: a cluster randomized clinical trial.

    Science.gov (United States)

    Anderson-Hanley, Cay; Arciero, Paul J; Brickman, Adam M; Nimon, Joseph P; Okuma, Naoko; Westen, Sarah C; Merz, Molly E; Pence, Brandt D; Woods, Jeffrey A; Kramer, Arthur F; Zimmerman, Earl A

    2012-02-01

    Dementia cases may reach 100 million by 2050. Interventions are sought to curb or prevent cognitive decline. Exercise yields cognitive benefits, but few older adults exercise. Virtual reality-enhanced exercise or "exergames" may elicit greater participation. To test the following hypotheses: (1) stationary cycling with virtual reality tours ("cybercycle") will enhance executive function and clinical status more than traditional exercise; (2) exercise effort will explain improvement; and (3) brain-derived neurotrophic growth factor (BDNF) will increase. Multi-site cluster randomized clinical trial (RCT) of the impact of 3 months of cybercycling versus traditional exercise, on cognitive function in older adults. Data were collected in 2008-2010; analyses were conducted in 2010-2011. 102 older adults from eight retirement communities enrolled; 79 were randomized and 63 completed. A recumbent stationary ergometer was utilized; virtual reality tours and competitors were enabled on the cybercycle. Executive function (Color Trails Difference, Stroop C, Digits Backward); clinical status (mild cognitive impairment; MCI); exercise effort/fitness; and plasma BDNF. Intent-to-treat analyses, controlling for age, education, and cluster randomization, revealed a significant group X time interaction for composite executive function (p=0.002). Cybercycling yielded a medium effect over traditional exercise (d=0.50). Cybercyclists had a 23% relative risk reduction in clinical progression to MCI. Exercise effort and fitness were comparable, suggesting another underlying mechanism. A significant group X time interaction for BDNF (p=0.05) indicated enhanced neuroplasticity among cybercyclists. Cybercycling older adults achieved better cognitive function than traditional exercisers, for the same effort, suggesting that simultaneous cognitive and physical exercise has greater potential for preventing cognitive decline. This study is registered at Clinicaltrials.gov NCT01167400. Copyright

  2. Appendectomy Skin Closure Technique, Randomized Controlled Trial: Changing Paradigms (ASC).

    Science.gov (United States)

    Andrade, Luis Angel Medina; Muñoz, Franz Yeudiel Pérez; Báez, María Valeria Jiménez; Collazos, Stephanie Serrano; de Los Angeles Martinez Ferretiz, Maria; Ruiz, Brenda; Montes, Oscar; Woolf, Stephanie; Noriega, Jessica Gonzalez; Aparicio, Uriel Maldonado; Gonzalez, Israel Gonzalez

    2016-11-01

    Appendectomy is the most frequent and urgent gastrointestinal surgery. Overtime, the surgical techniques have been improved upon, in order to reduce complications, get better cosmetic results, and limit the discomfort associated with this procedure, by its high impact in the surgery departments. The traditional skin closure is associated with a poor cosmetic result and it requires stitches removal, alongside the pain associated with this procedure, and no benefits were demonstrated in the literature regarding separated stitches over intradermic stitch. This is a randomized controlled trial, and our objective is to compare two different skin closure techniques in open appendectomy. A prospective randomized trial method was used, with a total number of 208 patients participating in the study, after acute appendicitis diagnosis in the emergency department. They were randomized into two groups: patients who would receive skin closure with a unique absorbable intradermic stitch (Group A) and another group that would receive the traditional closure technique, consistent in non-absorbable separated stitches (Group B). General characteristics like gender, age, Body Mass Index (BMI), comorbidities, and allergies were registered. Days of Evolution (DOE) until surgery, previous use of antibiotics, complicated or uncomplicated appendicitis, surgical time, and wound complications like skin infection, dehiscence, seroma or abscess were also registered in each case. 8 patients were excluded due to negative appendicitis during surgery and lack of follow-up. Two groups, each containing 100 patients, were formed. General characteristics and parity were compared, and no statistically significant differences were observed. Difference in the surgical time (Group A: 47.35 min vs Group B: 54.13 min, p  25 kg/m2 and seroma (p = .006), BMI > 25 kg/m2 and abscess (p = .02), surgical time >50 min and seroma (p 2 DOE and abscess (p = .001), and complicated appendicitis with

  3. A randomized clinical trial of treatment for lumbar segmental rigidity.

    Science.gov (United States)

    Mayer, Tom G; Gatchel, Robert J; Keeley, Janice; McGeary, Don; Dersh, Jeffrey; Anagnostis, Christopher

    2004-10-15

    A randomized single-blind clinical trial of facet injections plus exercise, versus exercise alone, in chronic disabling work-related lumbar spinal disorders (CDWRLSD), accompanied by pilot interrater reliability and facet syndrome prevalence studies. To systematically investigate the use of facet injections as an adjunct to supervised lumbar stretching exercises in regaining lumbar range of motion (ROM) following prolonged deconditioning after work-related lumbar injuries. To assess interrater reliability of visual assessment of segmental rigidity (SR), and to evaluate the prevalence of facet syndrome in cases of lumbar SR. Corticosteroid joint injections have often been used to reduce musculoskeletal inflammation to facilitate joint mobilization in the presence of degenerative arthritis. Lumbar segmental rigidity is a recently described entity usually associated with painful chronic spinal disorders and postoperative spine surgery. Previous work has shown that SR and lumbar ROM improves with a brief intervention consisting of facet injections followed by specific stretching exercises. No systematic study has investigated the potential benefits of a combination of facet injections and exercise over supervised exercises alone to treat lumbar SR. Similarly, no study has assessed the association between SR and the facet syndrome. From a group of consecutive patients (n = 421) with CDWRLSD referred for tertiary rehabilitation between November 1999 and January 2001, 70 were noted to have SR on intake physical examination. The first part of this study assessed interrater reliability for detecting SR, and intrarater reliability for 3-segment true lumbar ROM measurements. Patients randomly assigned to participate in supervised stretching exercises with the addition of fluoroscopically guided bilateral facet injections at the involved levels (Group A, n = 36) also underwent facet syndrome prevalence assessment at the time of injection. They were compared to a randomly

  4. A randomised multicentre trial of acupuncture in patients with seasonal allergic rhinitis – trial intervention including physician and treatment characteristics

    OpenAIRE

    Ortiz, Miriam; Witt, Claudia M; Binting, Sylvia; Helmreich, Cornelia; Hummelsberger, Josef; Pfab, Florian; Wullinger, Michael; Irnich, Dominik; Linde, Klaus; Niggemann, Bodo; Willich, Stefan N; Brinkhaus, Benno

    2014-01-01

    Background In a large randomised trial in patients with seasonal allergic rhinitis (SAR), acupuncture was superior compared to sham acupuncture and rescue medication. The aim of this paper is to describe the characteristics of the trial’s participating physicians and to describe the trial intervention in accordance with the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) guidelines, to make details of the trial intervention more transparent to researchers a...

  5. When is informed consent required in cluster randomized trials in health research?

    Science.gov (United States)

    2011-01-01

    This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the second of the questions posed, namely, from whom, when, and how must informed consent be obtained in CRTs in health research? The ethical principle of respect for persons implies that researchers are generally obligated to obtain the informed consent of research subjects. Aspects of CRT design, including cluster randomization, cluster level interventions, and cluster size, present challenges to obtaining informed consent. Here we address five questions related to consent and CRTs: How can a study proceed if informed consent is not possible? Is consent to randomization always required? What information must be disclosed to potential subjects if their cluster has already been randomized? Is passive consent a valid substitute for informed consent? Do health professionals have a moral obligation to participate as subjects in CRTs designed to improve professional practice? We set out a framework based on the moral foundations of informed consent and international regulatory provisions to address each of these questions. First, when informed consent is not possible, a study may proceed if a research ethics committee is satisfied that conditions for a waiver of consent are satisfied. Second, informed consent to randomization may not be required if it is not possible to approach subjects at the time of randomization. Third, when potential subjects are approached after cluster randomization, they must be provided with a detailed description of the interventions in the trial arm to which their cluster has been randomized; detailed information on interventions in other trial arms need not be provided. Fourth, while passive consent may serve a variety of practical ends, it

  6. Systematic evaluation of the methodology of randomized controlled trials of anticoagulation in patients with cancer

    Directory of Open Access Journals (Sweden)

    Rada Gabriel

    2013-02-01

    Full Text Available Abstract Background Randomized controlled trials (RCTs that are inappropriately designed or executed may provide biased findings and mislead clinical practice. In view of recent interest in the treatment and prevention of thrombotic complications in cancer patients we evaluated the characteristics, risk of bias and their time trends in RCTs of anticoagulation in patients with cancer. Methods We conducted a comprehensive search, including a search of four electronic databases (MEDLINE, EMBASE, ISI the Web of Science, and CENTRAL up to February 2010. We included RCTs in which the intervention and/or comparison consisted of: vitamin K antagonists, unfractionated heparin (UFH, low molecular weight heparin (LMWH, direct thrombin inhibitors or fondaparinux. We performed descriptive analyses and assessed the association between the variables of interest and the year of publication. Results We included 67 RCTs with 24,071 participants. In twenty one trials (31% DVT diagnosis was triggered by clinical suspicion; the remaining trials either screened for DVT or were unclear about their approach. 41 (61%, 22 (33%, and 11 (16% trials respectively reported on major bleeding, minor bleeding, and thrombocytopenia. The percentages of trials satisfying risk of bias criteria were: adequate sequence generation (85%, adequate allocation concealment (61%, participants’ blinding (39%, data collectors’ blinding (44%, providers’ blinding (41%, outcome assessors’ blinding (75%, data analysts’ blinding (15%, intention to treat analysis (57%, no selective outcome reporting (12%, no stopping early for benefit (97%. The mean follow-up rate was 96%. Adequate allocation concealment and the reporting of intention to treat analysis were the only two quality criteria that improved over time. Conclusions Many RCTs of anticoagulation in patients with cancer appear to use insufficiently rigorous outcome assessment methods and to have deficiencies in key methodological

  7. Randomized controlled trial of a lay-facilitated angina management programme.

    Science.gov (United States)

    Furze, Gill; Cox, Helen; Morton, Veronica; Chuang, Ling-Hsiang; Lewin, Robert J P; Nelson, Pauline; Carty, Richard; Norris, Heather; Patel, Nicky; Elton, Peter

    2012-10-01

    This article reports a randomized controlled trial of lay-facilitated angina management (registered trial acronym: LAMP). Previously, a nurse-facilitated angina programme was shown to reduce angina while increasing physical activity, however most people with angina do not receive a cardiac rehabilitation or self-management programme. Lay people are increasingly being trained to facilitate self-management programmes. A randomized controlled trial comparing a lay-facilitated angina management programme with routine care from an angina nurse specialist. Participants with new stable angina were randomized to the angina management programme (intervention: 70 participants) or advice from an angina nurse specialist (control: 72 participants). Primary outcome was angina frequency at 6 months; secondary outcomes at 3 and 6 months included: risk factors, physical functioning, anxiety, depression, angina misconceptions and cost utility. Follow-up was complete in March 2009. Analysis was by intention-to-treat; blind to group allocation. There was no important difference in angina frequency at 6 months. Secondary outcomes, assessed by either linear or logistic regression models, demonstrated important differences favouring the intervention group, at 3 months for: Anxiety, angina misconceptions and for exercise report; and at 6 months for: anxiety; depression; and angina misconceptions. The intervention was considered cost-effective. The angina management programme produced some superior benefits when compared to advice from a specialist nurse. © 2012 Blackwell Publishing Ltd.

  8. Acupuncture for sequelae of Bell's palsy: a randomized controlled trial protocol

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    Kim Yong-Suk

    2011-03-01

    Full Text Available Abstract Objective Incomplete recovery from facial palsy has a long-term impact on the quality of life, and medical options for the sequelae of Bell's palsy are limited. Invasive treatments and physiotherapy have been employed to relieve symptoms, but there is limited clinical evidence for their effectiveness. Acupuncture is widely used on Bell's palsy patients in East Asia, but there is insufficient evidence for its effectiveness on Bell's palsy sequelae. The objective is to evaluate the efficacy and safety of acupuncture in patients with sequelae of Bell's palsy. Method/Design This study consists of a randomized controlled trial with two parallel arms: an acupuncture group and a waitlist group. The acupuncture group will receive acupuncture treatment three times per week for a total of 24 sessions over 8 weeks. Participants in the waitlist group will not receive any acupuncture treatments during this 8 week period, but they will participate in the evaluations of symptoms at the start of the study, at 5 weeks and at 8 weeks after randomization, at which point the same treatment as the acupuncture group will be provided. The primary outcome will be analyzed by the change in the Facial Disability Index (FDI from baseline to week eight. The secondary outcome measures will include FDI from baseline to week five, House-Brackmann Grade, lip mobility, and stiffness scales. Trial registration Current Controlled-Trials ISRCTN43104115; registration date: 06 July 2010; the date of the first patient's randomization: 04 August 2010

  9. The effect of cluster size variability on statistical power in cluster-randomized trials.

    Directory of Open Access Journals (Sweden)

    Stephen A Lauer

    Full Text Available The frequency of cluster-randomized trials (CRTs in peer-reviewed literature has increased exponentially over the past two decades. CRTs are a valuable tool for studying interventions that cannot be effectively implemented or randomized at the individual level. However, some aspects of the design and analysis of data from CRTs are more complex than those for individually randomized controlled trials. One of the key components to designing a successful CRT is calculating the proper sample size (i.e. number of clusters needed to attain an acceptable level of statistical power. In order to do this, a researcher must make assumptions about the value of several variables, including a fixed mean cluster size. In practice, cluster size can often vary dramatically. Few studies account for the effect of cluster size variation when assessing the statistical power for a given trial. We conducted a simulation study to investigate how the statistical power of CRTs changes with variable cluster sizes. In general, we observed that increases in cluster size variability lead to a decrease in power.

  10. Vasectomy by ligation and excision, with or without fascial interposition: a randomized controlled trial [ISRCTN77781689

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    Chen-Mok Mario

    2004-03-01

    Full Text Available Abstract Background Randomized controlled trials comparing different vasectomy occlusion techniques are lacking. Thus, this multicenter randomized trial was conducted to compare the probability of the success of ligation and excision vasectomy with, versus without, fascial interposition (i.e. placing a layer of the vas sheath between two cut ends of the vas. Methods The trial was conducted between December 1999 and June 2002 with a single planned interim analysis. Men requesting vasectomies at eight outpatient clinics in seven countries in North America, Latin America, and Asia were included in the study. The men were randomized to receive vasectomy with versus without fascial interposition. All surgeons performed the vasectomies using the no-scalpel approach to the vas. Participants had a semen analysis two weeks after vasectomy and then every four weeks up to 34 weeks. The primary outcome measure was time to azoospermia. Additional outcome measures were time to severe oligozoospermia ( Results We halted recruitment after the planned interim analysis, when 841 men had been enrolled. Fascial interposition decreased time to azoospermia (hazard ratio [HR], 1.35; P Conclusion Fascial interposition significantly improves vasectomy success when ligation and excision is the method of vas occlusion. A limitation of this study is that the correlation between postvasectomy sperm concentrations and risk of pregnancy is not well quantified.

  11. Hip-Hop to Health Jr. Randomized Effectiveness Trial

    Science.gov (United States)

    Kong, Angela; Buscemi, Joanna; Stolley, Melinda R.; Schiffer, Linda A.; Kim, Yoonsang; Braunschweig, Carol L.; Gomez-Perez, Sandra L.; Blumstein, Lara B.; Van Horn, Linda; Dyer, Alan R.; Fitzgibbon, Marian L.

    2015-01-01

    Introduction The preschool years provide a unique window of opportunity to intervene on obesity-related lifestyle risk factors during the formative years of a child’s life. The purpose of this study was to assess the impact of a preschool-based obesity prevention effectiveness trial at 1-year follow-up. Design RCT. Settings/participants Primarily African American children (aged 3–5 years, N=618) attending Head Start preschool programs administered by Chicago Public Schools. Methods Eighteen preschools were randomly assigned in 2007–2008 to receive either: (1) a 14-week teacher-delivered intervention focused on healthy lifestyle behaviors; or (2) a 14-week teacher-delivered general health curriculum (control group). Main outcome measures The primary outcome, BMI, was measured at baseline, post-intervention, and 1-year follow-up. Diet and screen time behaviors were also assessed at these time points. Multilevel mixed effects models were used to test for between-group differences. Data were analyzed in 2014. Results Significant between-group differences were observed in diet, but not in BMI z-score or screen time at 1-year follow-up. Diet differences favored the intervention arm over controls in overall diet quality (p=0.02) and in subcomponents of diet quality, as measured by the Healthy Eating Index-2005, and in fruit intake (servings/day, excludes juice) (p=0.02). Diet quality worsened more among controls than the intervention group at 1-year follow-up. Conclusions The adaptation of Hip-Hop to Health Jr. produced modest benefits in diet quality, but did not significantly impact weight gain trajectory. Not unlike other effectiveness trials, this real-world version delivered by Head Start teachers produced fewer benefits than the more rigorous efficacy trial. It is important to understand and build upon the lessons learned from these types of trials so that we can design, implement, and disseminate successful evidence-based programs more widely and effectively

  12. Transcranial direct current stimulation in post-stroke dysphagia: a systematic review of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Kavian Ghandehari

    2016-07-01

    Full Text Available Introduction: The aim of this research was to systematically review all the randomized controlled trials that have evaluated the effect of transcranial direct current stimulation (tDCS on post-stroke dysphagia. Methods: Three electronic databases were searched for relevant articles that were uploaded from their inception to March 2015: PubMed, Cochrane Library (Cochrane Central Register of Controlled Trials, and Scopus. All data was that was related to the location of the cerebrovascular accident (CVA, the parameters of tDCS, post-stroke time to commencement of tDCS, the stimulated hemisphere, stimulation dose, any outcome measurements, and follow-up duration were extracted and assessed. Finally, a number of observations were generated through a qualitative synthesis of the extracted data.Result: Three eligible randomized controlled trials were included in the systematic review. All three trials reported that, in comparison to a placebo, tDCS had a statistically significant effect on post-stroke dysphagia.Discussion: The results of our systematic review suggest that tDCS may represent a promising novel treatment for post-stroke dysphagia. However, to date, little is known about the optimal parameters of tDCS for relieving post-stroke dysphagia. Further studies are warranted to refine this promising intervention by exploring the optimal parameters of tDCS.Conclusion: Since brainstem swallowing centers have bilateral cortical innervations, measures that enhance cortical input and sensorimotor control of brainstem swallowing may facilitate recovery from dysphagia.

  13. Lorcaserin plus lifestyle modification for weight loss maintenance: Rationale and design for a randomized controlled trial.

    Science.gov (United States)

    Tronieri, Jena Shaw; Alfaris, Nasreen; Chao, Ariana M; Pearl, Rebecca L; Alamuddin, Naji; Bakizada, Zayna M; Berkowitz, Robert I; Wadden, Thomas A

    2017-08-01

    Few studies have examined the efficacy of recently approved medications for chronic weight management in facilitating the maintenance of lost weight. This paper provides an overview of the design and rationale for a trial investigating whether lorcaserin, when combined with behavioral weight loss maintenance sessions (WLM), will facilitate the maintenance of losses of ≥5% of initial weight. In this two-phase trial, participants with obesity will enroll in a 14-week run-in diet program consisting of weekly group lifestyle modification sessions and a 1000-1200kcal/d meal replacement diet. Participants who complete this weight induction phase and lose at least 5% of initial weight will then be randomized to 52weeks of WLM plus lorcaserin or WLM plus placebo. We hypothesize that at 52weeks post randomization, participants assigned to WLM plus lorcaserin will achieve significantly better maintenance of the prior 5% weight loss. We will recruit 182 adults with obesity to participate in the diet run-in, 136 of whom (75%) are expected to become eligible for the randomized controlled trial. Co-primary outcomes include the percentage of participants who maintain a loss of at least 5% of initial weight at week 52 and change in weight (kg) from randomization to week 52. This two-phase design will allow us to determine the potential efficacy of chronic weight management using lorcaserin for maintaining initial losses of at least 5% body weight, induced by the use of a structured meal-replacement diet. This combined approach holds promise of achieving larger long-term weight losses. NCT02388568 on ClinicalTrials.gov. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. Randomized controlled trial on the effectiveness of a multicomponent intervention on migraine: A study protocol.

    Science.gov (United States)

    Renjith, Vishnu; Pai, Aparna; Radhakrishnan, Kurupath; Nayak, Baby S; Devi, Elsa Sanatombi; Ladd, Elissa; George, Anice

    2017-10-11

    To describe a randomized controlled trial protocol that evaluates the effectiveness of a multicomponent intervention in improving the outcomes (quality of life, disability, intensity, frequency and duration) of patients with migraine. Migraine affects various facets of Quality of Life and results in moderate to high levels of disability among migraineurs. Migraine pain can be intense and unremitting that can interfere with the daily routine and reduce the ability to think and function normally. Many people can lower their risk of a migraine by simply avoiding stress, getting enough sleep, eating regularly and by avoiding triggers. Hence, the present study aims at evaluating the effectiveness of a multicomponent intervention in managing migraine headaches. The multicomponent intervention includes behavioural lifestyle modification program and sessions of pranayama (a form of yogic breathing exercise). The study is a prospective, randomized, controlled, single-blinded trial with parallel arms. The study participants are randomized to intervention and control arms. The participants randomized to the intervention arm would receive the specific multicomponent intervention based on the protocol. The participants in the control arm would receive routine care. They are followed up for 24 weeks and the outcomes are assessed. Various studies report that non-pharmacological therapies and integrative therapies play a major role in the management of migraine headaches. The findings of the study are expected to open up new horizons in health care arena emphasizing the use of non-pharmacological therapy for less focused areas of primary care health problems such as migraine. The trial is registered with the Clinical Trials Registry India (CTRI). The CTRI India is one of the primary registries in the WHO registry network (Ctri.nic.in, ). CTRI reference ID: CTRI/2015/10/006282. © 2017 John Wiley & Sons Ltd.

  15. Block urn design - a new randomization algorithm for sequential trials with two or more treatments and balanced or unbalanced allocation

    Science.gov (United States)

    Zhao, Wenle; Weng, Yanqiu

    2011-01-01

    Permuted block design is the most popular randomization method used in clinical trials, especially for trials with more than two treatments and unbalanced allocation, because of its consistent imbalance control and simplicity in implementation. However, the risk of selection biases caused by high proportion of deterministic assignments is a cause of concern. Efron’s biased coin design and Wei’s urn design provide better allocation randomness without deterministic assignments, but they do not consistently control treatment imbalances. Alternative randomization designs with improved performances have been proposed over the past few decades, including Soares and Wu’s big stick design, which has high allocation randomness, but is limited to two-treatment balanced allocation scenarios only, and Berger’s maximal procedure design which has a high allocation randomness and a potential for more general trial scenarios, but lacks the explicit function for the conditional allocation probability and is more complex to implement than most other designs. The block urn design proposed in this paper combines the advantages of existing randomization designs while overcoming their limitations. Statistical properties of the new algorithm are assessed and compared to currently available designs via analytical and computer simulation approaches. The results suggest that the block urn design simultaneously provides consistent imbalance control and high allocation randomness. It can be easily implemented for sequential clinical trials with two or more treatments and balanced or unbalanced allocation. PMID:21893215

  16. The Risk of Bias in Randomized Trials in General Dentistry Journals.

    Science.gov (United States)

    Hinton, Stephanie; Beyari, Mohammed M; Madden, Kim; Lamfon, Hanadi A

    2015-01-01

    The use of a randomized controlled trial (RCT) research design is considered the gold standard for conducting evidence-based clinical research. In this present study, we aimed to assess the quality of RCTs in dentistry and create a general foundation for evidence-based dentistry on which to perform subsequent RCTs. We conducted a systematic assessment of bias of RCTs in seven general dentistry journals published between January 2011 and March 2012. We extracted study characteristics in duplicate and assessed each trial's quality using the Cochrane Risk of Bias tool. We compared risk of bias across studies graphically. Among 1,755 studies across seven journals, we identified 67 RCTs. Many included studies were conducted in Europe (39%), with an average sample size of 358 participants. These studies included 52% female participants and the maximum follow-up period was 13 years. Overall, we found a high percentage of unclear risk of bias among included RCTs, indicating poor quality of reporting within the included studies. An overall high proportion of trials with an "unclear risk of bias" suggests the need for better quality of reporting in dentistry. As such, key concepts in dental research and future trials should focus on high-quality reporting.

  17. Chinese Herbal Medicine Paratherapy for Parkinson's Disease: A Meta-Analysis of 19 Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Yan Wang

    2012-01-01

    Full Text Available Parkinson's disease (PD is a common and debilitating neurodegenerative disorder that needs long-term levodopa administration and can result in progressive deterioration of body functions, daily activities and participation. The objective of this meta-analysis evaluates the clinical efficacy and safety of Chinese herbal medicine (CHM as an adjunct therapy for PD patients. Methodological issues include a systematic literature search between 1950 and April 2011 to identify randomized trials involving CHM adjuvant therapy versus western conventional treatment. The outcome measures assessed were the reduction in scores of Unified Parkinson's Disease Rating Scale (UPDRS and adverse effects. 19 trials involving 1371 participants were included in the meta-analysis. As compared to western conventional treatment, CHM adjuvant therapy resulted in greater improvement in UPDRS I, II, III, IV scores, and UPDRS I–IV total scores (P<0.001. Adverse effects were reported in 9 studies. The side effects in CHM adjuvant therapy group were generally less than or lighter than the conventional treatment group. In conclusion, CHM adjuvant therapy may potentially alleviate symptoms of PD and generally appeared to be safe and well tolerated by PD patients. However, well-designed, randomized, placebo-controlled clinical trials are still needed due to the generally low methodological quality of the included studies.

  18. Efficacy and safety of Suanzaoren decoction for primary insomnia: a systematic review of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Xie Cheng-long

    2013-01-01

    Full Text Available Abstract Background Insomnia is a widespread human health problem, but there currently are the limitations of conventional therapies available. Suanzaoren decoction (SZRD is a well known classic Chinese herbal prescription for insomnia and has been treating people’s insomnia for more than thousand years. The objective of this study was to evaluate the efficacy and safety of SZRD for insomnia. Methods A systematic literature search was performed for 6 databases up to July of 2012 to identify randomized control trials (RCTs involving SZRD for insomniac patients. The methodological quality of RCTs was assessed independently using the Cochrane Handbook for Systematic Reviews of Interventions. Results Twelve RCTs with total of 1376 adult participants were identified. The methodological quality of all included trials are no more than 3/8 score. Majority of the RCTs concluded that SZRD was more significantly effective than benzodiazepines for treating insomnia. Despite these positive outcomes, there were many methodological shortcomings in the studies reviewed, including insufficient information about randomization generation and absence of allocation concealment, lack of blinding and no placebo control, absence of intention-to-treat analysis and lack of follow-ups, selective publishing and reporting, and small number of sample sizes. A number of clinical heterogeneity such as diagnosis, intervention, control, and outcome measures were also reviewed. Only 3 trials reported adverse events, whereas the other 9 trials did not provide the safety information. Conclusions Despite the apparent reported positive findings, there is insufficient evidence to support efficacy of SZRD for insomnia due to the poor methodological quality and the small number of trials of the included studies. SZRD seems generally safe, but is insufficient evidence to make conclusions on the safety because fewer studies reported the adverse events. Further large sample-size and well

  19. Wet cupping therapy for treatment of herpes zoster: a systematic review of randomized controlled trials

    Science.gov (United States)

    Cao, Huijuan; Zhu, Chenjun; Liu, Jianping

    2011-01-01

    Background Wet cupping is a traditional Chinese medicine therapy commonly used in treating herpes zoster in China, and clinical studies have shown that wet cupping may have beneficial effect on herpes zoster compared with western medication. Methods We included randomized controlled trials on wet cupping for herpes zoster. We searched PubMed, the Cochrane Library (Issue 3, 2008), China Network Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), and Wan Fang Database. All searches ended in February 2009. Two authors extracted data and assessed the trials quality independently. RevMan 5.0.18 software was used for data analysis with effect estimate presented as relative risk (RR) and mean difference (MD) with a 95% confidence interval (CI). Results 8 RCTs involving 651 patients were included, and the methodological quality of trials was generally fair in terms of randomization, blinding and intention-to-treat analysis. Meta-analyses showed wet cupping was superior to medications regarding the number of cured patients (RR 2.49, 95%CI 1.91 to 3.24, pcupping plus medications was significantly better than medications alone on number of cured patients (RR 1.93, 95%CI 1.23 to 3.04, p=0.005), but no difference in symptom improvement (RR 1.00, 95%CI 0.92 to 1.08, p=0.98). There were no serious adverse effects with related to wet cupping therapy in the included trials. Conclusions Wet cupping appears to be effective in treatment of herpes zoster. However, further large, rigorous designed trials are warranted. PMID:21280462

  20. Effects of Steroids on Quality of Recovery and Adverse Events after General Anesthesia: Meta-Analysis and Trial Sequential Analysis of Randomized Clinical Trials.

    Science.gov (United States)

    Mihara, Takahiro; Ishii, Tomoko; Ka, Koui; Goto, Takahisa

    2016-01-01

    Quality of recovery (QoR) after surgery is a relevant outcome. The early postoperative quality of recovery of a patient can be determined using the QoR-40 questionnaire. The aim of this meta-analysis and Trial Sequential Analysis was to determine if perioperative administration of glucocorticosteroids improved patients' quality of recovery after general anesthesia and if adverse events occurred. We searched six databases, including trial registration sites. Randomized clinical trials reporting the efficacy of glucocorticosteroids on quality of recovery evaluated using the QoR-40 after general anesthesia were eligible. The QoR-40 data were combined as the mean difference with confidence intervals using a random-effects model. The I2 statistic was used to assess heterogeneity. The quality of the trials was evaluated using the Cochrane methodology. Moreover, Trial Sequential Analysis was carried out to prevent the inflation of type 1 errors caused by multiple testing and sparse data. We also assessed adverse events. Three randomized clinical trials (totaling 301 patients) were analyzed. The results from one published and four unpublished randomized clinical trials were unavailable. Dexamethasone was investigated in all three trials, and the results suggested that it significantly improved QoR-40 at postoperative day one scores compared with placebo (mean difference [95% confidence interval]: 14.2 points [10.4 to 18.1]; P analysis because of the absence of trials with low risk of bias. The Trial Sequential Analysis-adjusted confidence interval was -1.6 to 30.0, indicating that further trials are required. The reporting of adverse events was insufficient. These findings indicate that perioperative dexamethasone administration may improve short-term (i.e., one day) quality of recovery after general anesthesia and surgery. We need more randomized clinical trials with low risk of bias assessing the effects of glucocorticosteroids on quality of life, other outcomes, and

  1. Placement Of Cardiac PacemaKEr Trial (POCKET – rationale and design: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Peter Magnusson

    2017-04-01

    Full Text Available BackgroundA pacemaker system consists of one or two leads connected to a device that is implanted into a pocket formed just below the collarbone. This pocket is typically subcutaneous, that is, located just above the pectoral fascia. Even though the size of pacemakers has decreased markedly, complications due to superficial implants do occur. An alternative technique would be intramuscular placement of the pacemaker device, but there are no randomized controlled trials (RCTs to support this approach, which is the rationale for the Placement Of Cardiac PacemaKEr Trial (POCKET. The aim is to study if intramuscular is superior to subcutaneous placement of a pacemaker pocket.MethodsIn October 2016, we started to enroll 200 consecutive patients with an indication for bradycardia pacemaker implantation. Patients are randomized to random block sizes, stratified by age group (cut-off: 65 years and sex, and then randomized to either subcutaneous or intramuscular implant. A concealed allocation procedure is employed, using sequentially numbered, sealed envelopes. Pocket site is blinded to the patient and in all subsequent care. The primary endpoint is patient overall satisfaction with the pocket location at 24 months as measured using a visual analog scale (VAS 0-10. Secondary endpoints are: complications, patient-reported satisfaction at 1, 12, and 24 months (overall satisfaction, pain, discomfort, degree of unsightly appearance, movement problems, and sleep problems due to device.ConclusionsPOCKET is a prospective interventional RCT designed to evaluate if intramuscular is superior to subcutaneous placement of a bradycardia pacemaker during a two-year follow-up.

  2. Placement Of Cardiac PacemaKEr Trial (POCKET – rationale and design: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Peter Magnusson

    2017-04-01

    Full Text Available Background: A pacemaker system consists of one or two leads connected to a device that is implanted into a pocket formed just below the collarbone. This pocket is typically subcutaneous, that is, located just above the pectoral fascia. Even though the size of pacemakers has decreased markedly, complications due to superficial implants do occur. An alternative technique would be intramuscular placement of the pacemaker device, but there are no randomized controlled trials (RCTs to support this approach, which is the rationale for the Placement Of Cardiac PacemaKEr Trial (POCKET. The aim is to study if intramuscular is superior to subcutaneous placement of a pacemaker pocket. Methods: In October 2016, we started to enroll 200 consecutive patients with an indication for bradycardia pacemaker implantation. Patients are randomized to random block sizes, stratified by age group (cut-off: 65 years and sex, and then randomized to either subcutaneous or intramuscular implant. A concealed allocation procedure is employed, using sequentially numbered, sealed envelopes. Pocket site is blinded to the patient and in all subsequent care. The primary endpoint is patient overall satisfaction with the pocket location at 24 months as measured using a visual analog scale (VAS 0-10. Secondary endpoints are: complications, patient-reported satisfaction at 1, 12, and 24 months (overall satisfaction, pain, discomfort, degree of unsightly appearance, movement problems, and sleep problems due to device. Conclusions: POCKET is a prospective interventional RCT designed to evaluate if intramuscular is superior to subcutaneous placement of a bradycardia pacemaker during a two-year follow-up.

  3. Inversion therapy in patients with pure single level lumbar discogenic disease: a pilot randomized trial.

    Science.gov (United States)

    Prasad, K S Manjunath; Gregson, Barbara A; Hargreaves, Gerard; Byrnes, Tiernan; Winburn, Philip; Mendelow, A David

    2012-01-01

    Backache and sciatica due to protuberant disc disease is a major cause of lost working days and health expenditure. Surgery is a well-established option in the management flowchart. There is no strong evidence proving that traction for sciatica is effective. We report a pilot prospective randomized controlled trial comparing inversion traction and physiotherapy with standard physiotherapy alone in patients awaiting lumbar disc surgery. This study sought to study the feasibility of a randomized controlled trial on the effect of inversion therapy in patients with single level lumbar discogenic disease, who had been listed for surgery. This was a single centre prospective randomized controlled trial undertaken at the Regional Neurosciences Centre, Newcastle Upon Tyne, UK. It was a prospective randomized controlled trial where patients awaiting surgery for pure lumbar discogenic disease within the ambit of the prestated inclusion/exclusion criteria were allocated to either physiotherapy or physiotherapy and intermittent traction with an inversion device. Post-treatment assessment made by blinded observers at 6 weeks for various outcome measures included the Roland Morris Disability Questionnaire (RMDQ) Score, Short Form 36 (SF 36), Oswestry Disability Index (ODI), Visual Analogue Pain Score (VAS), magnetic resonance imaging (MRI) appearance and the need for surgery. Avoidance of surgery was considered a treatment success. Twenty-six patients were enrolled and 24 were randomized [13 to inversion + physiotherapy and 11 to physiotherapy alone (control)]. Surgery was avoided in 10 patients (76.9%) in the inversion group, whereas it was averted in only two patients (22.2%) in the control group. Cancellation of the proposed operation was a clinical decision based on the same criteria by which the patient was listed for surgery initially. There were no significant differences in the RMDQ, SF 36, ODI, VAS or MRI results between the two groups. Intermittent traction with an

  4. Reexamination of a Meta-Analysis of the Effect of Antioxidant Supplementation on Mortality and Health in Randomized Trials

    OpenAIRE

    Blumberg, Jeffrey B.; Iris Zöllner; Jana Tinz; Tilman Grune; Biesalski, Hans K.

    2010-01-01

    A recent meta-analysis of selected randomized clinical trials (RCTs), in which population groups of differing ages and health status were supplemented with various doses of b-carotene, vitamin A, and/or vitamin E, found that these interventions increased all-cause mortality. However, this meta-analysis did not consider the rationale of the constituent RCTs for antioxidant supplementation, none of which included mortality as a primary outcome. As the rationale for these trials was to test the ...

  5. Strengthening patient-centred communication in rural Ugandan health centres: A theory-driven evaluation within a cluster randomized trial.

    OpenAIRE

    Nayiga, S; Diliberto, D; Taaka, L; Nabirye, C; Haaland, A.; Staedke, SG; Chandler, CI

    2014-01-01

    This article describes a theory-driven evaluation of one component of an intervention to improve the quality of health care at Ugandan public health centres. Patient-centred services have been advocated widely, but such approaches have received little attention in Africa. A cluster randomized trial is evaluating population-level outcomes of an intervention with multiple components, including ?patient-centred services.? A process evaluation was designed within this trial to articulate and eval...

  6. The impact of data errors on the outcome of randomized clinical trials

    NARCIS (Netherlands)

    Buyse, Marc; Squifflet, Pierre; Coart, Elisabeth; Quinaux, Emmanuel; Punt, Cornelis J. A.; Saad, Everardo D.

    2017-01-01

    Background/aims: Considerable human and financial resources are typically spent to ensure that data collected for clinical trials are free from errors. We investigated the impact of random and systematic errors on the outcome of randomized clinical trials. Methods: We used individual patient data

  7. Ipsilateral transversus abdominis plane block provides effective analgesia after appendectomy in children: a randomized controlled trial.

    LENUS (Irish Health Repository)

    Carney, John

    2010-10-01

    The transversus abdominis plane (TAP) block provides effective postoperative analgesia in adults undergoing major abdominal surgery. Its efficacy in children remains unclear, with no randomized clinical trials in this population. In this study, we evaluated its analgesic efficacy over the first 48 postoperative hours after appendectomy performed through an open abdominal incision, in a randomized, controlled, double-blind clinical trial.

  8. Is the randomized controlled drug trial in Europe lagging behind the USA?

    NARCIS (Netherlands)

    Lambers Heerspink, Hiddo J.; Knol, Mirjam J.; Tijssen, Robert J. W.; van Leeuwen, Thed N.; Grobbee, Diederick E.; de Zeeuw, Dick

    2008-01-01

    WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT? center dot The USA, UK and Germany have a strong position in performance of drug and nondrug randomized controlled trials. center dot Europe's position in the quantitative and qualitative performance in drug randomized controlled trials in particular, and

  9. Event detection using population-based health care databases in randomized clinical trials

    DEFF Research Database (Denmark)

    Thuesen, Leif; Jensen, Lisette Okkels; Tilsted, Hans Henrik

    2013-01-01

    To describe a new research tool, designed to reflect routine clinical practice and relying on population-based health care databases to detect clinical events in randomized clinical trials.......To describe a new research tool, designed to reflect routine clinical practice and relying on population-based health care databases to detect clinical events in randomized clinical trials....

  10. Colloid solutions for fluid resuscitation in patients with sepsis: systematic review of randomized controlled trials.

    Science.gov (United States)

    Zhong, Jing-Zi; Wei, Dan; Pan, Hong-Fei; Chen, Yu-Jun; Liang, Xiu-An; Yang, Zhi-Yong; Tang, Hua-Bo

    2013-10-01

    Colloids are widely used for fluid resuscitation in patients with sepsis. But the optimal type of fluid remains unclear. Our aim was to assess the effects on mortality and safety of different colloid solutions in patients with sepsis requiring volume replacement by examining direct comparisons of colloid solutions. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, China Biological Medicine Database, VIP Chinese Journals Database, and CNKI China National Knowledge Infrastructure Whole Article Database. Randomized clinical trials comparing different colloids in septic patients needing fluid resuscitation were selected. Seventeen randomized clinical trials with a total 1281 participants met the inclusion criteria. Mortality was obtained in all trials. For intervention of albumin vs. hydroxyethyl starch solution (HES), the relative risk (RR) of death was 0.98 (95% confidence interval [CI] 0.74-1.30). For intervention of albumin vs. gelatin, the RR of death was 2.4 (95% CI 0.31-18.35). For intervention of gelatin vs. HES, the RR of death was 1.02 (95% CI 0.79-1.32). For the intervention of HES vs. dextran, the RR of death was 1.38 (95% CI 0.28-6.78). For the intervention of gelatin vs. dextran, RR of death was not estimable. For albumin vs. dextran, no trial was included. Four trials of intervention of albumin vs. HES recorded the change of severity score. There is no evidence that one colloid solution is more effective and safer than another for fluid resuscitation in sepsis. The severity score is improved in HES, but the confidence intervals are wide. Copyright © 2013 Elsevier Inc. All rights reserved.

  11. Precision therapy for epilepsy due to KCNT1 mutations: A randomized trial of oral quinidine.

    Science.gov (United States)

    Mullen, Saul A; Carney, Patrick W; Roten, Annie; Ching, Michael; Lightfoot, Paul A; Churilov, Leonid; Nair, Umesh; Li, Melody; Berkovic, Samuel F; Petrou, Steven; Scheffer, Ingrid E

    2018-01-02

    To evaluate quinidine as a precision therapy for severe epilepsy due to gain of function mutations in the potassium channel gene KCNT1. A single-center, inpatient, order-randomized, blinded, placebo-controlled, crossover trial of oral quinidine included 6 patients with severe autosomal dominant nocturnal frontal lobe epilepsy (ADNFLE) due to KCNT1 mutation. Order was block randomized and blinded. Four-day treatment blocks were used with a 2-day washout between. Dose started at 900 mg over 3 divided doses then, in subsequent participants, was reduced to 600 mg, then 300 mg. Primary outcome was seizure frequency measured on continuous video-EEG in those completing the trial. Prolonged QT interval occurred in the first 2 patients at doses of 900 and 600 mg quinidine per day, respectively, despite serum quinidine levels well below the therapeutic range (0.61 and 0.51 μg/mL, reference range 1.3-5.0 μg/mL). Four patients completed treatment with 300 mg/d without adverse events. Patients completing the trial had very frequent seizures (mean 14 per day, SD 7, median 13, interquartile range 10-18). Seizures per day were nonsignificantly increased by quinidine (median 2, 95% confidence interval -1.5 to +5, p = 0.15) and no patient had a 50% seizure reduction. Quinidine did not show efficacy in adults and teenagers with ADNFLE. Dose-limiting cardiac side effects were observed even in the presence of low measured serum quinidine levels. Although small, this trial suggests use of quinidine in ADNFLE is likely to be ineffective coupled with considerable cardiac risks. Australian Therapeutic Goods Administration Clinical Trial Registry (trial number 2015/0151). This study provides Class II evidence that for persons with severe epilepsy due to gain of function mutations in the potassium channel gene KCNT1, quinidine does not significantly reduce seizure frequency. Copyright © 2017 American Academy of Neurology.

  12. Effect of Guizhifulingwan (Keishibukuryogan) on climacteric syndrome: study protocol for a randomized controlled pilot trial.

    Science.gov (United States)

    Kim, Jung-Eun; Cho, Junghyo; Kwon, Ojin; Kim, Ae-Ran; Park, Hyo-Ju; Jung, So-Young; Kim, Joo-Hee; Kim, Mikyung; Lee, Hye-Yoon; Lee, Jun-Hwan

    2017-03-21

    The aim of this study is to explore the efficacy of Guizhifulingwan (GFW) in the treatment of climacteric syndrome in women. This is a single-center, randomized, placebo-controlled, parallel-group design pilot trial. Fifty participants with climacteric syndrome will be randomly allocated to the GFW or placebo group in a 1:1 ratio. The participants will be administered GFW or placebo granules three times a day for 4 weeks and will be followed up for a further 4 weeks. The primary outcome is the mean change in menopause rating scale score at 5 weeks after randomization. Secondary outcomes include the World Health Organization quality of life-BREF scores, degrees of upward movement of qi and lower abdominal resistance and tenderness, blood stasis pattern questionnaire scores, and results of blood tests including assays for lipid profile, high sensitivity C-reactive protein, follicle-stimulating hormone, and estradiol. The feasibility outcomes include recruitment and completion rates and adherence to medication. The results of this study will provide basic data for the design of a large-scale clinical trial for evaluating the efficacy of GFW in the treatment of climacteric syndrome in women. Clinical Research Information Service (CRIS), Republic of Korea, KCT0002040 . Registered on 5 September 2016.

  13. Association of run-in periods with weight loss in obesity randomized controlled trials.

    Science.gov (United States)

    Affuso, O; Kaiser, K A; Carson, T L; Ingram, K H; Schwiers, M; Robertson, H; Abbas, F; Allison, D B

    2014-01-01

    Study-level design characteristics that inform the optimal design of obesity randomized controlled trials (RCTs) have been examined in few studies. A pre-randomization run-in period is one such design element that may influence weight loss. We examined 311 obesity RCTs published between 1 January 2007 and 1 July 2009 that examine d weight loss or weight gain prevention as a primary or secondary end-point. Variables included run-in period, pre-post intervention weight loss, study duration (time), intervention type, percent female and degree of obesity. Linear regression was used to estimate weight loss as a function of (i) run-in (yes/no) and (ii) run-in, time, percent female, body mass index and intervention type. Interaction terms were also examined. Approximately 19% (18.6%) of the studies included a run-in period, with pharmaceutical studies having the highest frequency. Although all intervention types were associated with weight loss (Mean = 2.80 kg, SD = 3.52), the inclusion of a pre-randomization run-in was associated with less weight loss (P = 0.0017) compared with studies that did not include a run-in period. However, this association was not consistent across intervention types. Our results imply that in trials primarily targeting weight loss in adults, run-in periods may not be beneficial for improving weight loss outcomes in interventions. © 2013 The Authors. obesity reviews © 2013 International Association for the Study of Obesity.

  14. Stereotactic aspiration versus craniotomy for primary intracerebral hemorrhage: a meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Jia-Wei Wang

    Full Text Available BACKGROUND: A wealth of evidence based on the randomized controlled trials (RCTs has indicated that surgery may be a better choice in the management of primary intracerebral hemorrhage (ICH compared to conservative treatment. However, there is considerable controversy over selecting appropriate surgical procedures for ICH. Thus, this meta-analysis was performed to assess the effects of stereotactic aspiration compared to craniotomy in patients with ICH. METHODS: According to the study strategy, we searched PUBMED, EMBASE and Cochrane Central Register of Controlled Trials. Other sources such as the internet-based clinical trial registries, relevant journals and the lists of references were also searched. After literature searching, two investigators independently performed literature screening, assessment of quality of the included trials and data extraction. The outcome measures included death or dependence, total risk of complication, and the risk of rebleeding, gastrointestinal hemorrhage and systematic infection. RESULTS: Four RCTs with 2996 participants were included. The quality of the included trials was acceptable. Stereotactic aspiration significantly decreased the odds of death or dependence at the final follow-up (odds ratio (OR: 0.80, 95% confidence interval (CI: 0.69-0.93; P = 0.004 and the risk of intracerebral rebleeding (OR: 0.44, 95% CI: 0.26-0.74; P = 0.002 compared to craniotomy with no significant heterogeneity among the study results. CONCLUSIONS: The present meta-analysis provides evidence that the stereotactic aspiration may be associated with a reduction in the odds of being dead or dependent in primary ICH, which should be interpreted with caution. Further trials are needed to identify those patients most likely to benefit from the stereotactic aspiration.

  15. Evidence-based medicine, systematic reviews, and guidelines in interventional pain management: Part 2: Randomized controlled trials.

    Science.gov (United States)

    Manchikanti, Laxmaiah; Hirsch, Joshua A; Smith, Howard S

    2008-01-01

    Evidence-based medicine (EBM) is a shift in medical paradigms and about solving clinical problems, acknowledging that intuition, unsystematic clinical experience, and pathophysiologic rationale are insufficient grounds for clinical decision-making. The importance of randomized trials has been created by the concept of the hierarchy of evidence in guiding therapy. Even though the concept of hierarchy of evidence is not absolute, in modern medicine, most researchers synthesizing the evidence may or may not follow the principles of EBM, which requires that a formal set of rules must complement medical training and common sense for clinicians to interpret the results of clinical research. N of 1 randomized controlled trials (RCTs) has been positioned as the top of the hierarchy followed by systematic reviews of randomized trials, single randomized trial, systematic review of observational studies, single observational study, physiologic studies, and unsystematic clinical observations. However, some have criticized that the hierarchy of evidence has done nothing more than glorify the results of imperfect experimental designs on unrepresentative populations in controlled research environments above all other sources of evidence that may be equally valid or far more applicable in given clinical circumstances. Design, implementation, and reporting of randomized trials is crucial. The biased interpretation of results from randomized trials, either in favor of or opposed to a treatment, and lack of proper understanding of randomized trials, leads to a poor appraisal of the quality. Multiple types of controlled trials include placebo-controlled and pragmatic trials. Placebo controlled RCTs have multiple shortcomings such as cost and length, which limit the availability for studying certain outcomes, and may suffer from problems of faulty implementation or poor generalizability, despite the study design which ultimately may not be the prime consideration when weighing evidence

  16. Hospital-Level Care at Home for Acutely Ill Adults: a Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Levine, David M; Ouchi, Kei; Blanchfield, Bonnie; Diamond, Keren; Licurse, Adam; Pu, Charles T; Schnipper, Jeffrey L

    2018-02-06

    Hospitals are standard of care for acute illness, but hospitals can be unsafe, uncomfortable, and expensive. Providing substitutive hospital-level care in a patient's home potentially reduces cost while maintaining or improving quality, safety, and patient experience, although evidence from randomized controlled trials in the US is lacking. Determine if home hospital care reduces cost while maintaining quality, safety, and patient experience. Randomized controlled trial. Adults admitted via the emergency department with any infection or exacerbation of heart failure, chronic obstructive pulmonary disease, or asthma. Home hospital care, including nurse and physician home visits, intravenous medications, continuous monitoring, video communication, and point-of-care testing. Primary outcome was direct cost of the acute care episode. Secondary outcomes included utilization, 30-day cost, physical activity, and patient experience. Nine patients were randomized to home, 11 to usual care. Median direct cost of the acute care episode for home patients was 52% (IQR, 28%; p = 0.05) lower than for control patients. During the care episode, home patients had fewer laboratory orders (median per admission: 6 vs. 19; p Home patients were more physically active (median minutes, 209 vs. 78; p home patients, one occurred in control patients. Median direct cost for the acute care plus 30-day post-discharge period for home patients was 67% (IQR, 77%; p home-care services (22% vs. 55%; p = 0.08) and fewer readmissions (11% vs. 36%; p = 0.32). Patient experience was similar in both groups. The use of substitutive home-hospitalization compared to in-hospital usual care reduced cost and utilization and improved physical activity. No significant differences in quality, safety, and patient experience were noted, with more definitive results awaiting a larger trial. Trial Registration NCT02864420.

  17. Induced Hypertension for Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage: A Randomized Clinical Trial.

    Science.gov (United States)

    Gathier, Celine S; van den Bergh, Walter M; van der Jagt, Mathieu; Verweij, Bon H; Dankbaar, Jan Willem; Müller, Marcella C; Oldenbeuving, Annemarie W; Rinkel, Gabriel J E; Slooter, Arjen J C

    2018-01-01

    Induced hypertension is widely used to treat delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage, but a literature review shows that its presumed effectiveness is based on uncontrolled case-series only. We here report clinical outcome of aneurysmal subarachnoid hemorrhage patients with DCI included in a randomized trial on the effectiveness of induced hypertension. Aneurysmal subarachnoid hemorrhage patients with clinical symptoms of DCI were randomized to induced hypertension or no induced hypertension. Risk ratios for poor outcome (modified Rankin Scale score >3) at 3 months, with 95% confidence intervals, were calculated and adjusted for age, clinical condition at admission and at time of DCI, and amount of blood on initial computed tomographic scan with Poisson regression analysis. The trial aiming to include 240 patients was ended, based on lack of effect on cerebral perfusion and slow recruitment, when 21 patients had been randomized to induced hypertension, and 20 patients to no hypertension. With induced hypertension, the adjusted risk ratio for poor outcome was 1.0 (95% confidence interval, 0.6-1.8) and the risk ratio for serious adverse events 2.1 (95% confidence interval, 0.9-5.0). Before this trial, the effectiveness of induced hypertension for DCI in aneurysmal subarachnoid hemorrhage patients was unknown because current literature consists only of uncontrolled case series. The results from our premature halted trial do not add any evidence to support induced hypertension and show that this treatment can lead to serious adverse events. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01613235. © 2017 American Heart Association, Inc.

  18. Efficacy of smoking prevention program 'Smoke-free Kids': study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    van Schayck Onno CP

    2009-12-01

    Full Text Available Abstract Background A strong increase in smoking is noted especially among adolescents. In the Netherlands, about 5% of all 10-year olds, 25% of all 13-year olds and 62% of all 17-year olds report ever smoking. In the U.S., an intervention program called 'Smoke-free Kids' was developed to prevent children from smoking. The present study aims to assess the effects of this home-based smoking prevention program in the Netherlands. Methods/Design A randomized controlled trial is conducted among 9 to 11-year old children of primary schools. Participants are randomly assigned to the intervention and control conditions. The intervention program consists of five printed activity modules designed to improve parenting skills specific to smoking prevention and parent-child communication regarding smoking. These modules will include additional sheets with communication tips. The modules for the control condition will include solely information on smoking and tobacco use. Initiation of cigarette smoking (first instance of puffing on a lighted cigarette, susceptibility to cigarette smoking, smoking-related cognitions, and anti-smoking socialization will be the outcome measures. To collect the data, telephone interviews with mothers as well as with their child will be conducted at baseline. Only the children will be examined at post-intervention follow-ups (6, 12, 24, and 36 months after the baseline. Discussion This study protocol describes the design of a randomized controlled trial that will evaluate the effectiveness of a home-based smoking prevention program. We expect that a significantly lower number of children will start smoking in the intervention condition compared to control condition as a direct result of this intervention. If the program is effective, it is applicable in daily live, which will facilitate implementation of the prevention protocol. Trial registration Netherlands Trial Register NTR1465

  19. Cupping therapy versus acupuncture for pain-related conditions: a systematic review of randomized controlled trials and trial sequential analysis.

    Science.gov (United States)

    Zhang, Ya-Jing; Cao, Hui-Juan; Li, Xin-Lin; Yang, Xiao-Ying; Lai, Bao-Yong; Yang, Guo-Yang; Liu, Jian-Ping

    2017-01-01

    Both cupping therapy and acupuncture have been used in China for a long time, and their target indications are pain-related conditions. There is no systematic review comparing the effectiveness of these two therapies. To compare the beneficial effectiveness and safety between cupping therapy and acupuncture for pain-related conditions to provide evidence for clinical practice. Protocol of this review was registered in PROSPERO (CRD42016050986). We conducted literature search from six electronic databases until 31st March 2017. We included randomized trials comparing cupping therapy with acupuncture on pain-related conditions. Methodological quality of the included studies was evaluated by risk of bias tool. Mean difference, risk ratio, risk difference and their 95% confidence interval were used to report the estimate effect of the pooled results through meta-analysis or the results from each individual study. Trial sequential analysis (TSA) was applied to adjust random errors and calculate the sample size. Twenty-three randomized trials with 2845 participants were included covering 12 pain-related conditions. All included studies were of poor methodological quality. Three meta-analyses were conducted, which showed similar clinical beneficial effects of cupping therapy and acupuncture for the rate of symptom improvement in cervical spondylosis (RR 1.13, 95% CI 1.01 to 1.26; n = 646), lateral femoral cutaneous neuritis (RR 1.10, 95% CI 1.00 to 1.22; n = 102) and scapulohumeral periarthritis (RR 1.31, 95% CI 1.15 to 1.51; n = 208). Results from other outcomes (such as visual analogue and numerical rating scale) in each study also showed no statistical significant difference between these two therapies for all included pain-related conditions. The results of TSA for cervical spondylosis demonstrated that the current available data have not reached a powerful conclusion. No serious adverse events related to cupping therapy or acupuncture was found in included

  20. Safety of oral use of nimesulide in children: systematic review of randomized controlled trials.

    Science.gov (United States)

    Gupta, Piyush; Sachdev, H P S

    2003-06-01

    Nimesulide has been widely used to treat fever in children. Due to reports of adverse drug reactions, discontinuation or modification of its use has been suggested. To evaluate the safety of oral use of nimesulide in children. Systematic review of published randomized controlled trials. Electronic searches of databases (PubMed, Cochrane, Toxnet) for relevant trials upto January 2003 using specified key words. The studies were also identified by searching the references of available meta-analyses and review articles, and bibliography of pertinent references. Randomized controlled trials in children (less than or equal to 18 years of age) comparing the use of oral nimesulide with placebo or other antipyretic, anti-inflammatory or analgesic agents. The primary outcome variable included the commonly encountered adverse effects of nimesulide therapy, i.e., hypothermia, abdominal symptoms, gastrointestinal bleeding, and elevated liver enzymes. One of the authors developed a questionnaire and independently extracted data on methods, type of participants, interventions and outcomes. The meta-analysis was conducted using pooled relative risk with 95% confidence intervals, with random effects model assumption. We identified 16 trials that fulfilled the inclusion criteria. These included 1254 subjects, with mean age between 22 -140 months. Nimesulide was primarily used for its antipyretic (10 trials) or anti-inflammatory and analgesic activity (4 trials). One study each evaluated the symptomatic improvement in ARI and bronchial asthma. The control group included administration of placebo (3 studies), paracetamol (9 studies), and ketoprofen, naproxen, mefanemic acid and aspirin in one study each. The pooled effect sizes of various adverse events as compared between nimesulide and different control groups were: hypothermia (RR: 1.055; 95% CI: 0.184 - 6.047; P = 0.952), abdominal symptoms (RR: 0.464; 95% CI: 0.264 - 0.816; P = 0.008), gastrointestinal bleeding (RR: 0.914; 95% CI

  1. Aerobic exercise for Alzheimer's disease: A randomized controlled pilot trial.

    Science.gov (United States)

    Morris, Jill K; Vidoni, Eric D; Johnson, David K; Van Sciver, Angela; Mahnken, Jonathan D; Honea, Robyn A; Wilkins, Heather M; Brooks, William M; Billinger, Sandra A; Swerdlow, Russell H; Burns, Jeffrey M

    2017-01-01

    There is increasing interest in the role of physical exercise as a therapeutic strategy for individuals with Alzheimer's disease (AD). We assessed the effect of 26 weeks (6 months) of a supervised aerobic exercise program on memory, executive function, functional ability and depression in early AD. This study was a 26-week randomized controlled trial comparing the effects of 150 minutes per week of aerobic exercise vs. non-aerobic stretching and toning control intervention in individuals with early AD. A total of 76 well-characterized older adults with probable AD (mean age 72.9 [7.7]) were enrolled and 68 participants completed the study. Exercise was conducted with supervision and monitoring by trained exercise specialists. Neuropsychological tests and surveys were conducted at baseline,13, and 26 weeks to assess memory and executive function composite scores, functional ability (Disability Assessment for Dementia), and depressive symptoms (Cornell Scale for Depression in Dementia). Cardiorespiratory fitness testing and brain MRI was performed at baseline and 26 weeks. Aerobic exercise was associated with a modest gain in functional ability (Disability Assessment for Dementia) compared to individuals in the ST group (X2 = 8.2, p = 0.02). There was no clear effect of intervention on other primary outcome measures of Memory, Executive Function, or depressive symptoms. However, secondary analyses revealed that change in cardiorespiratory fitness was positively correlated with change in memory performance and bilateral hippocampal volume. Aerobic exercise in early AD is associated with benefits in functional ability. Exercise-related gains in cardiorespiratory fitness were associated with improved memory performance and reduced hippocampal atrophy, suggesting cardiorespiratory fitness gains may be important in driving brain benefits. ClinicalTrials.gov NCT01128361.

  2. A randomized trial of social media from Circulation.

    Science.gov (United States)

    Fox, Caroline S; Bonaca, Marc A; Ryan, John J; Massaro, Joseph M; Barry, Karen; Loscalzo, Joseph

    2015-01-06

    Medical journals use social media to distribute the findings of published articles. Whether social media exposure to original articles improves article impact metrics is uncertain. Articles were randomized to receive targeted social media exposure from Circulation, including postings on the journal's Facebook and Twitter feeds. The primary end point was 30-day article page views. We conducted an intention-to-treat analysis comparing article page views by the Wilcoxon Rank sum test between articles randomized to social media as compared with those in the control group, which received no social media from Circulation. Prespecified subgroups included article type (population/clinical/basic), US versus non-US corresponding author, and whether the article received an editorial. Overall, 243 articles were randomized: 121 in the social media arm and 122 in the control arm. There was no difference in median 30-day page views (409 [social media] versus 392 [control], P=0.80). No differences were observed by article type (clinical, population, or basic science; P=0.19), whether an article had an editorial (P=0.87), or whether the corresponding author was from the United States (P=0.73). A social media strategy for a cardiovascular journal did not increase the number of times an article was viewed. Further research is necessary to understand and quantify the ways in which social media can increase the impact of published cardiovascular research. © 2014 American Heart Association, Inc.

  3. Fragility of Results in Ophthalmology Randomized Controlled Trials: A Systematic Review.

    Science.gov (United States)

    Shen, Carl; Shamsudeen, Isabel; Farrokhyar, Forough; Sabri, Kourosh

    2017-12-11

    Evidence-based medicine is guided by our interpretation of randomized controlled trials (RCTs) that address important clinical questions. Evaluation of the robustness of statistically significant outcomes adds a crucial element to the global assessment of trial findings. The purpose of this systematic review was to determine the robustness of ophthalmology RCTs through application of the Fragility Index (FI), a novel metric of the robustness of statistically significant outcomes. Systematic review. A literature search (MEDLINE) was performed for all RCTs published in top ophthalmology journals and ophthalmology-related RCTs published in high-impact journals in the past 10 years. Two reviewers independently screened 1811 identified articles for inclusion if they (1) were a human ophthalmology-related trial, (2) had a 1:1 prospective study design, and (3) reported a statistically significant dichotomous outcome in the abstract. All relevant data, including outcome, P value, number of patients in each group, number of events in each group, number of patients lost to follow-up, and trial characteristics, were extracted. The FI of each RCT was calculated and multivariate regression applied to determine predictive factors. The 156 trials had a median sample size of 91.5 (range, 13-2593) patients/eyes, and a median of 28 (range, 4-2217) events. The median FI of the included trials was 2 (range, 0-48), meaning that if 2 non-events were switched to events in the treatment group, the result would lose its statistical significance. A quarter of all trials had an FI of 1 or less, and 75% of trials had an FI of 6 or less. The FI was less than the number of missing data points in 52.6% of trials. Predictive factors for FI by multivariate regression included smaller P value (P < 0.001), larger sample size (P = 0.001), larger number of events (P = 0.011), and journal impact factor (P = 0.029). In ophthalmology trials, statistically significant dichotomous results are often

  4. Randomized trial of oral teriflunomide for relapsing multiple sclerosis.

    Science.gov (United States)

    O'Connor, Paul; Wolinsky, Jerry S; Confavreux, Christian; Comi, Giancarlo; Kappos, Ludwig; Olsson, Tomas P; Benzerdjeb, Hadj; Truffinet, Philippe; Wang, Lin; Miller, Aaron; Freedman, Mark S

    2011-10-06

    Teriflunomide is a new oral disease-modifying therapy for relapsing forms of multiple sclerosis. We concluded a randomized trial involving 1088 patients with multiple sclerosis, 18 to 55 years of age, with a score of 0 to 5.5 on the Expanded Disability Status Scale and at least one relapse in the previous year or at least two relapses in the previous 2 years. Patients were randomly assigned (in a 1:1:1 ratio) to placebo, 7 mg of teriflunomide, or 14 mg of teriflunomide once daily for 108 weeks. The primary end point was the annualized relapse rate, and the key secondary end point was confirmed progression of disability for at least 12 weeks. Teriflunomide reduced the annualized relapse rate (0.54 for placebo vs. 0.37 for teriflunomide at either 7 or 14 mg), with relative risk reductions of 31.2% and 31.5%, respectively (Pteriflunomide at 7 mg (P=0.08), and 20.2% with teriflunomide at 14 mg (P=0.03). Both teriflunomide doses were superior to placebo on a range of end points measured by magnetic resonance imaging (MRI). Diarrhea, nausea, and hair thinning were more common with teriflunomide than with placebo. The incidence of elevated alanine aminotransferase levels (≥1 times the upper limit of the normal range) was higher with teriflunomide at 7 mg and 14 mg (54.0% and 57.3%, respectively) than with placebo (35.9%); the incidence of levels that were at least 3 times the upper limit of the normal range was similar in the lower- and higher-dose teriflunomide groups and the placebo group (6.3%, 6.7%, and 6.7%, respectively). Serious infections were reported in 1.6%, 2.5%, and 2.2% of patients in the three groups, respectively. No deaths occurred. Teriflunomide significantly reduced relapse rates, disability progression (at the higher dose), and MRI evidence of disease activity, as compared with placebo. (Funded by Sanofi-Aventis; TEMSO ClinicalTrials.gov number, NCT00134563.).

  5. The risk of unblinding was infrequently and incompletely reported in 300 randomized clinical trial publications

    DEFF Research Database (Denmark)

    Bello, Segun; Moustgaard, Helene; Hróbjartsson, Asbjørn

    2014-01-01

    randomized clinical trials indexed in PubMed in 2010. Two authors read the trial publications and extracted data independently. RESULTS: Twenty-four trial publications, or 8% (95% confidence interval [CI], 5, 12%), explicitly reported the risk of unblinding, of which 16 publications, or 5% (95% CI, 3, 8...

  6. Design and methods for a randomized clinical trial treating comorbid obesity and major depressive disorder

    Directory of Open Access Journals (Sweden)

    Crawford Sybil

    2008-09-01

    Full Text Available Abstract Background Obesity is often comorbid with depression and individuals with this comorbidity fare worse in behavioral weight loss treatment. Treating depression directly prior to behavioral weight loss treatment might bolster weight loss outcomes in this population, but this has not yet been tested in a randomized clinical trial. Methods and design This randomized clinical trial will examine whether behavior therapy for depression administered prior to standard weight loss treatment produces greater weight loss than standard weight loss treatment alone. Obese women with major depressive disorder (N = 174 will be recruited from primary care clinics and the community and randomly assigned to one of the two treatment conditions. Treatment will last 2 years, and will include a 6-month intensive treatment phase followed by an 18-month maintenance phase. Follow-up assessment will occur at 6-months and 1- and 2 years following randomization. The primary outcome is weight loss. The study was designed to provide 90% power for detecting a weight change difference between conditions of 3.1 kg (standard deviation of 5.5 kg at 1-year assuming a 25% rate of loss to follow-up. Secondary outcomes include depression, physical activity, dietary intake, psychosocial variables and cardiovascular risk factors. Potential mediators (e.g., adherence, depression, physical activity and caloric intake of the intervention effect on weight change will also be examined. Discussion Treating depression before administering intensive health behavior interventions could potentially boost the impact on both mental and physical health outcomes. Trial registration NCT00572520

  7. Reporting of adverse events in randomized controlled trials of highly active antiretroviral therapy: systematic review.

    Science.gov (United States)

    Chowers, Michal Y; Gottesman, Bat Sheva; Leibovici, Leonard; Pielmeier, Ulrike; Andreassen, Steen; Paul, Mical

    2009-08-01

    Our objectives were to systematically assess the quality of reporting of adverse events (AEs) in publications of randomized trials of highly active antiretroviral therapy (HAART), and to examine whether reporting quality affects the effect estimates reported for AEs. We searched the PubMed, Cochrane library and EMBASE electronic databases up to December 2008. We included all published randomized controlled trials assessing HAART for treatment-naive adult HIV-infected individuals, with 48 weeks' follow-up. The quality of AE reporting was extracted according to CONSORT guidelines. We pooled the relative risks for AEs and compared results by sponsorship and different reporting methods. Forty-nine trials, including 19 882 patients, published between 2000 and 2008, met the inclusion criteria. Only one of the trials reported on AE collection methods. Twenty-six trials reported only AEs attributed to drugs, 17 of which did not refer to the attribution methods. AE reporting was nearly always selective and selection criteria were highly variable, based on severity grading or occurrence threshold. Presentation of AEs above an occurrence threshold was more common in studies sponsored by industry (30/31) than in studies sponsored by non-profit organizations (3/18). Moreover, we showed that differences in the methods of reporting AEs may affect the results reported for AEs. No significant improvement in AE reporting was seen over this period. We found substantial variability in AE reporting. Variability was influenced by sponsor identity and affected outcomes. These facts obstruct our ability to choose HAART based on currently published data.

  8. Randomized controlled trial of a lay-facilitated angina management programme

    OpenAIRE

    Furze, Gill; Cox, Helen; Morton, Veronica; Chuang, Ling-Hsiang; Lewin, Robert JP; Nelson, Pauline; Carty, Richard; Norris, Heather; Patel, Nicky; Elton, Peter

    2012-01-01

    Aims This article reports a randomized controlled trial of lay-facilitated angina management (registered trial acronym: LAMP). Background Previously, a nurse-facilitated angina programme was shown to reduce angina while increasing physical activity, however most people with angina do not receive a cardiac rehabilitation or self-management programme. Lay people are increasingly being trained to facilitate self-management programmes. Design A randomized controlled trial comparing a lay-facilita...

  9. Contributions of the European trials (European randomized screening group) in computed tomography lung cancer screening.

    Science.gov (United States)

    Heuvelmans, Marjolein A; Vliegenthart, Rozemarijn; Oudkerk, Matthijs

    2015-03-01

    Lung cancer is the leading cause of cancer-related death worldwide. In 2011, the largest lung cancer screening trial worldwide, the US National Lung Screening Trial, published a 20% decrease in lung cancer-specific mortality in the computed tomography (CT)-screened group, compared with the group screened by chest x-ray. On the basis of this trial, different US guidelines recently have recommended CT lung cancer screening. However, several questions regarding the implementation of lung cancer screening need to be answered. In Europe, several lung cancer screening trials are ongoing. It is planned to pool the results of the lung cancer screening trials in European randomized lung cancer CT screening (EUCT). By pooling of the data, EUCT hopes to be able to provide additional information for the discussion of some important issues regarding the implementation of lung cancer screening by low-dose CT, including: the determination of the optimal screen population, the comparison between a volume-based and diameter-based nodule management protocol, and the determination of optimal screen intervals.

  10. The Effectiveness of Music in Pediatric Healthcare: A Systematic Review of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Karline Treurnicht Naylor

    2011-01-01

    Full Text Available The aim of this study was to systematically review the effectiveness of music on pediatric health-related outcomes. Five electronic databases were searched for randomized controlled/crossover trial designs published between 1984 and 2009. Eligible studies used music as a therapy or intervention, included participants 1 to 18 years, and focused on at least one health-related outcome (with the exclusion of procedural pain. Seventeen studies met the inclusion criteria. Quantitative synthesis was hampered by an inability to aggregate data arising from heterogeneity of interventions, outcomes and measurement tools. Qualitative synthesis revealed significant improvements in one or more health outcomes within four of seven trials involving children with learning and developmental disorders; two of three trials involving children experiencing stressful life events; and four of five trials involving children with acute and/or chronic physical illness. No significant effects were found for two trials involving children with mood disorders and related psychopathology. These findings offer limited qualitative evidence to support the effectiveness of music on health-related outcomes for children and adolescents with clinical diagnoses. Recommendations for establishing a consensus on research priorities and addressing methodological limitations are put forth to support the continued advancement of this popular intervention.

  11. Do Contemporary Randomized Controlled Trials Meet ESMO Thresholds for Meaningful Clinical Benefit?

    Science.gov (United States)

    Del Paggio, J C; Azariah, B; Sullivan, R; Hopman, W M; James, F V; Roshni, S; Tannock, I F; Booth, C M

    2017-01-01

    The European Society for Medical Oncology (ESMO) recently released a magnitude of clinical benefit scale (ESMO-MCBS) for systemic therapies for solid cancers. Here, we evaluate contemporary randomized controlled trials (RCTs) against the proposed ESMO thresholds for meaningful clinical benefit. RCTs evaluating systemic therapy for breast cancer, nonsmall cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic cancer published 2011-2015 were reviewed. Data were abstracted regarding trial characteristics and outcomes, and these were applied to the ESMO-MCBS. We also determined whether RCTs were designed to detect an effect that would meet clinical benefit as defined by the ESMO-MCBS. About 277 eligible RCTs were included (40% breast, 31% NSCLC, 22% CRC, 6% pancreas). Median sample size was 532 and 83% were funded by industry. Among all 277 RCTs, the experimental therapy was statistically superior to the control arm in 138 (50%) trials: results of only 31% (43/138) of these trials met the ESMO-MCBS clinical benefit threshold. RCTs with curative intent were more likely to meet clinically meaningful thresholds than those with palliative intent [61% (19/31) versus 22% (24/107), P meet ESMO-MCBS thresholds. Less than one-third of contemporary RCTs with statistically significant results meet ESMO thresholds for meaningful clinical benefit, and this represents only 15% of all published trials. Investigators, funding agencies, regulatory agencies, and industry should adopt more stringent thresholds for meaningful benefit in the design of future RCTs.

  12. Acupoint Stimulation for Fibromyalgia: A Systematic Review of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Huijuan Cao

    2013-01-01

    Full Text Available Background. Acupoint stimulation is popular for treatment of fibromyalgia though there is lack of comprehensive evaluation of current clinical evidence for its effect and safety. Objective. To systematically review the beneficial effects and safety of acupoint stimulation for fibromyalgia. Methods. We searched six electronic databases for randomized trials on acupoint stimulation for treatment of fibromyalgia. Two authors extracted data and assessed the trial quality independently. RevMan 5.2 software was used for data analyses with effect estimate presented as (standard mean difference and a 95% confidence interval. We defined minimum, medium, and large SMD effect sizes as 0.3, 0.5, and 0.75. Results. 16 RCTs with 1081 participants were involved in this review. Only two trials were evaluated as low risk of bias. Meta-analysis showed that acupuncture alone or combined with cupping therapy was superior to conventional medications on reducing pain scores and/or the number of tender points. However, acupuncture showed no better than sham acupuncture on pain reduction. There was no serious adverse event reported to be related to acupoint stimulation. Conclusions. Acupoint stimulation appears to be effective in treating fibromyalgia compared with medications. However, further large, rigorously designed trials are warranted due to insufficient methodological rigor in the included trials.

  13. Merocel versus Nasopore for nasal packing: a meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Jianzhang Wang

    Full Text Available OBJECTIVE: To compare the clinical outcomes, including efficacy and complications, of Merocel versus Nasopore as a nasal packing material after nasal surgery. METHODS: Relevant randomized controlled trials were identified from electronic databases (The Cochrane Library, PubMed, EMBASE, China National Knowledge Infrastructure and Chinese Biomedical Database. Conference proceedings and references from identified trials and review articles were also searched. Outcome measures were pain during nasal packing, pain and bleeding upon packing removal, pressure sensation, nasal blockage, formation of synechiae, mucosal healing, and patients' general satisfaction. RESULTS: Seven randomized controlled trials met criteria for analysis. Compared with Merocel, Nasopore significantly reduced patients' subjective symptoms including in situ pain (pain experienced while packing is in place, nasal pressure, pain and bleeding during packing removal, and increased patients' general satisfaction with nasal packing. There were no significant differences in nasal obstruction, adhesion and mucosal healing between the Merocel and Nasopore groups. CONCLUSIONS: Preliminary evidence suggests that Nasopore may be superior to Merocel as a nasal packing material with regard to in situ pain, pain and bleeding upon removal, pressure, and general satisfaction and does not differ from Merocel in terms of nasal obstruction, tissue adhesion, and long-term mucosal healing.

  14. Weight loss therapy for clinical management of patients with some atherosclerotic diseases: a randomized clinical trial.

    Science.gov (United States)

    Oshakbayev, Kuat; Dukenbayeva, Bibazhar; Otarbayev, Nurzhan; Togizbayeva, Gulnar; Tabynbayev, Nariman; Gazaliyeva, Meruyert; Idrisov, Alisher; Oshakbayev, Pernekul

    2015-11-25

    The prevalence and burden of atherosclerotic (AS) diseases are increasing during the last twenty years. Some studies show a close relationship between overweight and AS, but influence on AS diseases of different weight loss methods are still studying. The purpose of the research was to study the effectiveness of a weight loss program in AS patients in randomized controlled trial, and to develop a conception of evolution of AS. A randomized controlled prospective clinical trial including 97 people, from them 71 patients with various AS manifestations. Patients were divided in 2 subgroups for non-drug weight loss program, and conventional drug therapy. The weight loss program included calorie restriction with 100-150 kcal/day, fat-free vegetables, salt diet, and optimum physical activity. Statistical analysis was performed using SPSS for Windows version 17.0. The weight loss subgroup lost ranging between 7-20% from an initial weight (P = 0.016). Weight loss was achieved due to fatty mass reduction only (P = 0.005). Hemoglobin levels (P bone mineral density (P water (P = 0.006) and muscle masses (P = 0.0038) were increased in weight loss subgroup. Ejection fraction (P body fat. ClinicalTrials.gov NCT01700075. State registration is # 0109RK000079, code is O.0475 at the National Center for Scientific and Technical Information of the Republic of Kazakhstan.

  15. Acupoints Stimulation for Anxiety and Depression in Cancer Patients: A Quantitative Synthesis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Tao Wang

    2016-01-01

    Full Text Available This study aims at concluding the current evidence on the therapeutic effects of acupoints stimulation for cancer patients with anxiety and depression. Randomized controlled trials using acupoints stimulation for relieving anxiety and/or depression in cancer patients were searched, and 11 studies were finally included, of which eight trials compared acupoints stimulation with standard methods of treatment/care, and acupoints stimulation showed significantly better effects in improving depression than using standard methods of treatment/care. Four studies compared true acupoints stimulation with sham methods, and no significant differences can be found between groups for either depression or anxiety, although the pooled effects still favored true intervention. For the five studies that evaluated sleep quality, the results were conflicting, with three supporting the superiority of acupoints stimulation in improving sleep quality and two demonstrating no differences across groups. Acupoints stimulation seems to be an effective approach in relieving depression and anxiety in cancer patients, and placebo effects may partially contribute to the benefits. However, the evidence is not conclusive due to the limited number of included studies and the clinical heterogeneity identified among trials. More rigorous designed randomized, sham-controlled studies are necessary in future research.

  16. Yoga decreases insomnia in postmenopausal women: a randomized clinical trial.

    Science.gov (United States)

    Afonso, Rui Ferreira; Hachul, Helena; Kozasa, Elisa Harumi; Oliveira, Denise de Souza; Goto, Viviane; Rodrigues, Dinah; Tufik, Sérgio; Leite, José Roberto

    2012-02-01

    The practice of yoga has been proven to have positive effects on reducing insomnia. Studies have also shown its effects on reducing climacteric symptoms. To date, however, no studies that evaluate the effects of yoga on postmenopausal women with a diagnosis of insomnia in a randomized clinical trial have been conducted. The aim of this study was to evaluate the effect of yoga practice on the physical and mental health and climacteric symptoms of postmenopausal women with a diagnosis of insomnia. Postmenopausal women not undergoing hormone therapy, who were 50 to 65 years old, who had an apnea-hypopnea index less than 15, and who had a diagnosis of insomnia were randomly assigned to one of three groups, as follows: control, passive stretching, and yoga. Questionnaires were administered before and 4 months after the intervention to evaluate quality of life, anxiety and depression symptoms, climacteric symptoms, insomnia severity, daytime sleepiness, and stress. The volunteers also underwent polysomnography. The study lasted 4 months. There were 44 volunteers at the end of the study. When compared with the control group, the yoga group had significantly lower posttreatment scores for climacteric symptoms and insomnia severity and higher scores for quality of life and resistance phase of stress. The reduction in insomnia severity in the yoga group was significantly higher than that in the control and passive-stretching groups. This study showed that a specific sequence of yoga might be effective in reducing insomnia and menopausal symptoms as well as improving quality of life in postmenopausal women with insomnia.

  17. Promoting healthy weight with "stability skills first": a randomized trial.

    Science.gov (United States)

    Kiernan, Michaela; Brown, Susan D; Schoffman, Danielle E; Lee, Katherine; King, Abby C; Taylor, C Barr; Schleicher, Nina C; Perri, Michael G

    2013-04-01

    Although behavioral weight-loss interventions produce short-term weight loss, long-term maintenance remains elusive. This randomized trial examined whether learning a novel set of "stability skills" before losing weight improved long-term weight management. Stability skills were designed to optimize individuals' current satisfaction with lifestyle and self-regulatory habits while requiring the minimum effort and attention necessary. Overweight/obese women (N = 267) were randomly assigned to one of two 6-month interventions and assessed at baseline and at 6, 12, and 18 months. Maintenance First women participated first in an 8-week stability skills maintenance module and then in a standard 20-week behavioral weight-loss program. Weight Loss First women participated first in a standard 20-week behavioral weight-loss program and then in a standard 8-week problem-solving skills maintenance module. There was no intervention staff contact during the 12-month follow-up period (6-18 months). As designed, Maintenance First participants lost the same percentage of initial weight during the 6-month intervention period as Weight Loss First participants (M = -8.6%, SD = 5.7, vs. M = -9.1%, SD = 6.9; t = -0.6, p = .52). However, Maintenance First participants regained significantly less weight during the 12-month follow-up period (6-18 months) than Weight Loss First participants (M = 3.2 lb, SD = 10.4, vs. M = 7.3 lb, SD = 9.9 [M = 1.4 kg, SD = 4.7, vs. M = 3.3 kg, SD = 4.5]; t = 3.3, p = .001, d = 0.4). Learning stability skills before losing weight was successful in helping women to maintain weight loss without intervention staff contact during follow-up. These results can inform the study design of future innovative interventions.

  18. Aromatherapy as treatment for postoperative nausea: a randomized trial.

    Science.gov (United States)

    Hunt, Ronald; Dienemann, Jacqueline; Norton, H James; Hartley, Wendy; Hudgens, Amanda; Stern, Thomas; Divine, George

    2013-09-01

    Postoperative nausea (PON) is a common complication of anesthesia and surgery. Antiemetic medication for higher-risk patients may reduce but does not reliably prevent PON. We examined aromatherapy as a treatment for patients experiencing PON after ambulatory surgery. Our primary hypothesis was that in comparison with inhaling a placebo, PON will be reduced significantly by aromatherapy with (1) essential oil of ginger, (2) a blend of essential oils of ginger, spearmint, peppermint, and cardamom, or (3) isopropyl alcohol. Our secondary hypothesis was that the effectiveness of aromatherapy will depend upon the agent used. A randomized trial of aromatherapy with patients who reported nausea in the postanesthesia care unit was conducted at one ambulatory surgical center. Eligibility criteria were adult, able to give consent, and no history of coagulation problems or allergy to the aromatherapy agents. Before surgery, demographic and risk factors were collected. Patients with a nausea level of 1 to 3 on a verbal descriptive scale (0-3) received a gauze pad saturated with a randomly chosen aromatherapy agent and were told to inhale deeply 3 times; nausea (0-3) was then measured again in 5 minutes. Prophylactic and postnausea antiemetics were given as ordered by physicians or as requested by the patient. A total of 1151 subjects were screened for inclusion; 303 subjects reporting nausea were enrolled (26.3%), and 301 meeting protocol were analyzed (26.2%). The change in nausea level was significant for the blend (P aromatherapy was also significantly reduced with ginger or blend aromatherapy versus saline (P = 0.002 and P aromatherapy would be effective as a treatment for PON was supported. On the basis of our results, future research further evaluating aromatherapy is warranted. Aromatherapy is promising as an inexpensive, noninvasive treatment for PON that can be administered and controlled by patients as needed.

  19. Preventing alcohol-exposed pregnancies: a randomized controlled trial.

    Science.gov (United States)

    Floyd, R Louise; Sobell, Mark; Velasquez, Mary M; Ingersoll, Karen; Nettleman, Mary; Sobell, Linda; Mullen, Patricia Dolan; Ceperich, Sherry; von Sternberg, Kirk; Bolton, Burt; Johnson, Kenneth; Skarpness, Bradley; Nagaraja, Jyothi

    2007-01-01

    Prenatal alcohol exposure is a leading preventable cause of birth defects and developmental disabilities in the United States. A randomized controlled trial (2002-2005; data analyzed 2005-2006) of a brief motivational intervention to reduce the risk of an alcohol-exposed pregnancy (AEP) in preconceptional women by focusing on both risk drinking and ineffective contraception use. A total of 830 nonpregnant women, aged 18-44 years, and currently at risk for an AEP were recruited in six diverse settings in Florida, Texas, and Virginia. Combined settings had higher proportions of women at risk for AEP (12.5% overall) than in the general population (2%). Participants were randomized to receive information plus a brief motivational intervention (n=416) or to receive information only (n=414). The brief motivational intervention consisted of four counseling sessions and one contraception consultation and services visit. Women consuming more than five drinks on any day or more than eight drinks per week on average, were considered risk drinkers; women who had intercourse without effective contraception were considered at risk of pregnancy. Reversing either or both risk conditions resulted in reduced risk of an AEP. Across the follow-up period, the odds ratios (ORs) of being at reduced risk for AEP were twofold greater in the intervention group: 3 months, 2.31 (95% confidence interval [CI]=1.69-3.20); 6 months, 2.15 (CI=1.52-3.06); 9 months, 2.11 (CI=1.47-3.03). Between-groups differences by time phase were 18.0%, 17.0%, and 14. 8%, respectively. A brief motivational intervention can reduce the risk of an AEP.