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Sample records for 5-year randomized trial

  1. BST-CarGel® Treatment Maintains Cartilage Repair Superiority over Microfracture at 5 Years in a Multicenter Randomized Controlled Trial

    OpenAIRE

    Shive, Matthew S.; Stanish, William D; McCormack,Robert; Forriol, Francisco; Mohtadi, Nicholas; Pelet, Stéphane; Desnoyers, Jacques; Méthot, Stéphane; Vehik, Kendra; Restrepo, Alberto

    2015-01-01

    Objective The efficacy and safety of BST-CarGel®, a chitosan scaffold for cartilage repair was compared with microfracture alone at 1 year during a multicenter randomized controlled trial in the knee. This report was undertaken to investigate 5-year structural and clinical outcomes. Design The international randomized controlled trial enrolled 80 patients, aged 18 to 55 years, with grade III or IV focal lesions on the femoral condyles. Patients were randomized to receive BST-CarGel® treatment...

  2. A lifestyle intervention to reduce Type 2 diabetes risk in Dutch primary care: 2.5-year results of a randomized controlled trial.

    NARCIS (Netherlands)

    Vermunt, P.W.; Milder, I.E.; Wielaard, F.; Vries, J.H. de; Baan, C.A.; Oers, J.A. van; Westert, G.P.

    2012-01-01

    Diabet. Med. 29, e223-e231 (2012) ABSTRACT: Aims To determine the effectiveness of a 2.5-year lifestyle intervention for Type 2 diabetes prevention in Dutch general practice compared with usual care. Methods A randomized controlled trial of 925 individuals at high risk for Type 2 diabetes (FINDRISC-

  3. A Randomized, Double-masked Clinical Trial Comparing Four Periodontitis Treatment Strategies: 5-year Tooth Loss Results

    DEFF Research Database (Denmark)

    Preus, Hans R; Gjermo, Per; Baelum, Vibeke

    2016-01-01

    BACKGROUND: Tooth loss is the ultimate negative consequence of periodontitis, and reports of the extent to which different treatment strategies may influence the loss of teeth in the long run are hard to find. AIM: To test the hypothesis that there is no difference in the 5-year clinical outcome ...

  4. Deferiprone versus deferoxamine in sickle cell disease: results from a 5-year long-term Italian multi-center randomized clinical trial.

    Science.gov (United States)

    Calvaruso, Giusi; Vitrano, Angela; Di Maggio, Rosario; Ballas, Samir; Steinberg, Martin H; Rigano, Paolo; Sacco, Massimiliano; Telfer, Paul; Renda, Disma; Barone, Rita; Maggio, Aurelio

    2014-12-01

    Blood transfusion and iron chelation currently represent a supportive therapy to manage anemia, vasculopathy and vaso-occlusion crises in Sickle-Cell-Disease. Here we describe the first 5-year long-term randomized clinical trial comparing Deferiprone versus Deferoxamine in patients with Sickle-Cell-Disease. The results of this study show that Deferiprone has the same effectiveness as Deferoxamine in decreasing body iron burden, measured as repeated measurements of serum ferritin concentrations on the same patient over 5-years and analyzed according to the linear mixed-effects model (LMM) (p=0.822). Both chelators are able to decrease, significantly, serum ferritin concentrations, during 5-years, without any effect on safety (p=0.005). Moreover, although the basal serum ferritin levels were higher in transfused compared with non-transfused group (p=0.031), the changes over time in serum ferritin levels were not statistically significantly different between transfused and non-transfused cohort of patients (p=0.389). Kaplan-Meier curve, during 5-years of study, suggests that Deferiprone does not alter survival in comparison with Deferoxamine (p=0.38). In conclusion, long-term iron chelation therapy with Deferiprone was associated with efficacy and safety similar to that of Deferoxamine. Therefore, in patients with Sickle-Cell-Disease, Deferiprone may represent an effective long-term treatment option. PMID:24814618

  5. Randomized Comparison of Uterine Artery Embolization (UAE) with Surgical Treatment in Patients with Symptomatic Uterine Fibroids (REST Trial): Subanalysis of 5-Year MRI Findings

    Energy Technology Data Exchange (ETDEWEB)

    Ananthakrishnan, Ganapathy, E-mail: ganapathy.ananthakrishnan@nhs.net [Gartnavel General Hospital, Department of Interventional Radiology (United Kingdom); Murray, Lilian, E-mail: Lilian.murray@glasgow.ac.uk [Vital Statistics (United Kingdom); Ritchie, Moira, E-mail: moira.ritchie@ggc.scot.nhs.uk [Gartnavel General Hospital, Department of Interventional Radiology (United Kingdom); Murray, Gordon, E-mail: Gordon.murray@ed.ac.uk [Centre for Population Health Sciences, University of Edinburgh, Department of Medical Statistics (United Kingdom); Bryden, Fiona, E-mail: Fiona.bryden@ggc.scot.nhs.uk [Stobhill Hospital (United Kingdom); Lassman, Sue, E-mail: sue.lassman@ggc.scot.nhs.uk [Gartnavel General Hospital, Department of Interventional Radiology (United Kingdom); Lumsden, Mary Ann, E-mail: Maryann.lumsden@glasgow.ac.uk [Room 12, Level 4, Walton Building, Department of Medical Education and Gynaecology, Reproductive and Maternal Medicine (United Kingdom); Moss, Jon G., E-mail: jon.moss@ggc.scot.nhs.uk [Gartnavel General Hospital, Department of Interventional Radiology (United Kingdom)

    2013-06-15

    Purpose. To report 5-year contrast-enhanced magnetic resonance imaging findings of the REST trial recruits who underwent either uterine artery embolization (UAE) or myomectomy. Methods. A total of 157 patients were randomized to UAE or surgery (hysterectomy or myomectomy). Ninety-nine patients who had UAE and eight patients who had myomectomy were analyzed. MRI scans at baseline, 6 months, and 5 years were independently interpreted by two radiologists. Dominant fibroid diameter, uterine volume, total fibroid infarction (complete 100 %, almost complete 90-99 %, partial <90 %), and new fibroid formation were the main parameters assessed and related to the need for reintervention. Results. In the UAE group, mean {+-} standard deviation uterine volume was 670 {+-} 503, 422 {+-} 353, and 292 {+-} 287 mL at baseline, 6 months, and 5 years, respectively. Mean dominant fibroid diameter was 7.6 {+-} 3.0, 5.8 {+-} 2.9, and 5 {+-} 2.9 cm at baseline, 6 months, and 5 years. Fibroid infarction at 6 months was complete in 35 % of women, almost complete in 29 %, and partial in 36 %. Need for reintervention was 19, 10, and 33 % in these groups, respectively (p = 0.123). No myomectomy cases had further intervention. At 5 years, the prevalence of new fibroid was 60 % in the myomectomy group and 7 % in the UAE group (p = 0.008). Conclusion. There is a further significant reduction in both uterine volume and dominant fibroid diameter between 6 months and 5 years after UAE. Complete fibroid infarction does not translate into total freedom from a subsequent reintervention. New fibroid formation is significantly higher after myomectomy.

  6. Randomized Comparison of Uterine Artery Embolization (UAE) with Surgical Treatment in Patients with Symptomatic Uterine Fibroids (REST Trial): Subanalysis of 5-Year MRI Findings

    International Nuclear Information System (INIS)

    Purpose. To report 5-year contrast-enhanced magnetic resonance imaging findings of the REST trial recruits who underwent either uterine artery embolization (UAE) or myomectomy. Methods. A total of 157 patients were randomized to UAE or surgery (hysterectomy or myomectomy). Ninety-nine patients who had UAE and eight patients who had myomectomy were analyzed. MRI scans at baseline, 6 months, and 5 years were independently interpreted by two radiologists. Dominant fibroid diameter, uterine volume, total fibroid infarction (complete 100 %, almost complete 90–99 %, partial <90 %), and new fibroid formation were the main parameters assessed and related to the need for reintervention. Results. In the UAE group, mean ± standard deviation uterine volume was 670 ± 503, 422 ± 353, and 292 ± 287 mL at baseline, 6 months, and 5 years, respectively. Mean dominant fibroid diameter was 7.6 ± 3.0, 5.8 ± 2.9, and 5 ± 2.9 cm at baseline, 6 months, and 5 years. Fibroid infarction at 6 months was complete in 35 % of women, almost complete in 29 %, and partial in 36 %. Need for reintervention was 19, 10, and 33 % in these groups, respectively (p = 0.123). No myomectomy cases had further intervention. At 5 years, the prevalence of new fibroid was 60 % in the myomectomy group and 7 % in the UAE group (p = 0.008). Conclusion. There is a further significant reduction in both uterine volume and dominant fibroid diameter between 6 months and 5 years after UAE. Complete fibroid infarction does not translate into total freedom from a subsequent reintervention. New fibroid formation is significantly higher after myomectomy.

  7. Healthy Aging 5 Years After a Period of Daily Supplementation With Antioxidant Nutrients: A Post Hoc Analysis of the French Randomized Trial SU.VI.MAX.

    Science.gov (United States)

    Assmann, Karen E; Andreeva, Valentina A; Jeandel, Claude; Hercberg, Serge; Galan, Pilar; Kesse-Guyot, Emmanuelle

    2015-10-15

    This study's objective was to investigate healthy aging in older French adults 5 years after a period of daily nutritional-dose supplementation with antioxidant nutrients. The study was based on the double-blind, randomized trial, Supplementation with Antioxidant Vitamins and Minerals (SU.VI.MAX) Study (1994-2002) and the SU.VI.MAX 2 Follow-up Study (2007-2009). During 1994-2002, participants received a daily combination of vitamin C (120 mg), β-carotene (6 mg), vitamin E (30 mg), selenium (100 µg), and zinc (20 mg) or placebo. Healthy aging was assessed in 2007-2009 by using multiple criteria, including the absence of major chronic disease and good physical and cognitive functioning. Data from a subsample of the SU.VI.MAX 2 cohort, initially free of major chronic disease, with a mean age of 65.3 years in 2007-2009 (n = 3,966), were used to calculate relative risks. Supplementation was associated with a greater healthy aging probability among men (relative risk = 1.16, 95% confidence interval: 1.04, 1.29) but not among women (relative risk = 0.98, 95% confidence interval: 0.86, 1.11) or all participants (relative risk = 1.07, 95% confidence interval: 0.99, 1.16). Moreover, exploratory subgroup analyses indicated effect modification by initial serum concentrations of zinc and vitamin C. In conclusion, an adequate supply of antioxidant nutrients (equivalent to quantities provided by a balanced diet rich in fruits and vegetables) may have a beneficial role for healthy aging. PMID:26374140

  8. Effect of Breastfeeding Promotion on Early Childhood Caries and Breastfeeding Duration among 5 Year Old Children in Eastern Uganda: A Cluster Randomized Trial

    Science.gov (United States)

    Birungi, Nancy; Fadnes, Lars T.; Okullo, Isaac; Kasangaki, Arabat; Nankabirwa, Victoria; Ndeezi, Grace; Tumwine, James K.; Tylleskär, Thorkild; Lie, Stein Atle; Åstrøm, Anne Nordrehaug

    2015-01-01

    Background Although several studies have shown short term health benefits of exclusive breastfeeding (EBF), its long term consequences have not been studied extensively in low-income contexts. This study assessed the impact of an EBF promotion initiative for 6 months on early childhood caries (ECC) and breastfeeding duration in children aged 5 years in Mbale, Eastern Uganda. Methods Participants were recruited from the Ugandan site of the PROMISE- EBF cluster randomised trial (ClinicalTrials.gov no: NCT00397150). A total of 765 pregnant women from 24 clusters were included in the ratio 1:1 to receive peer counselled promotion of EBF as the intervention or standard of care. At the 5 year follow-up, ECC was recorded under field conditions using the World Health Organization’s decayed missing filled tooth (dmft) index. Adjusted negative binomial and linear regression were used in the analysis. Results Mean breastfeeding duration in the intervention and control groups (n=417) were 21.8 (CI 20.7–22.9) and 21.3(CI 20.7–21.9) months, respectively. The mean dmft was 1.5 (standard deviation [SD] 2.9) and 1.7 (SD 2.9) in the intervention and control groups, respectively. Corresponding prevalence estimates of ECC were 38% and 41%. Negative binomial regression analysis adjusted for cluster effects and loss-to-follow-up by inverse probability weights (IPW) showed an incidence-rate ratio (IRR) of 0.91 (95% CI 0.65–1.2). Comparing the effect of the trial arm on breastfeeding duration showed a difference in months of 0.48 (-0.72 to 1.7). Conclusion PROMISE EBF trial did not impact on early childhood caries or breastfeeding duration at 5 years of age. This study contributes to the body of evidence that promotion of exclusive breastfeeding does not raise oral health concerns. However, the high burden of caries calls for efforts to improve the oral health condition in this setting. Trial Registration ClinicalTrials.gov NCT00397150 PMID:25938681

  9. Effect of Breastfeeding Promotion on Early Childhood Caries and Breastfeeding Duration among 5 Year Old Children in Eastern Uganda: A Cluster Randomized Trial.

    Directory of Open Access Journals (Sweden)

    Nancy Birungi

    Full Text Available Although several studies have shown short term health benefits of exclusive breastfeeding (EBF, its long term consequences have not been studied extensively in low-income contexts. This study assessed the impact of an EBF promotion initiative for 6 months on early childhood caries (ECC and breastfeeding duration in children aged 5 years in Mbale, Eastern Uganda.Participants were recruited from the Ugandan site of the PROMISE- EBF cluster randomised trial (ClinicalTrials.gov no: NCT00397150. A total of 765 pregnant women from 24 clusters were included in the ratio 1:1 to receive peer counselled promotion of EBF as the intervention or standard of care. At the 5 year follow-up, ECC was recorded under field conditions using the World Health Organization's decayed missing filled tooth (dmft index. Adjusted negative binomial and linear regression were used in the analysis.Mean breastfeeding duration in the intervention and control groups (n=417 were 21.8 (CI 20.7-22.9 and 21.3(CI 20.7-21.9 months, respectively. The mean dmft was 1.5 (standard deviation [SD] 2.9 and 1.7 (SD 2.9 in the intervention and control groups, respectively. Corresponding prevalence estimates of ECC were 38% and 41%. Negative binomial regression analysis adjusted for cluster effects and loss-to-follow-up by inverse probability weights (IPW showed an incidence-rate ratio (IRR of 0.91 (95% CI 0.65-1.2. Comparing the effect of the trial arm on breastfeeding duration showed a difference in months of 0.48 (-0.72 to 1.7.PROMISE EBF trial did not impact on early childhood caries or breastfeeding duration at 5 years of age. This study contributes to the body of evidence that promotion of exclusive breastfeeding does not raise oral health concerns. However, the high burden of caries calls for efforts to improve the oral health condition in this setting.ClinicalTrials.gov NCT00397150.

  10. Breast-Conserving Treatment With Partial or Whole Breast Irradiation for Low-Risk Invasive Breast Carcinoma-5-Year Results of a Randomized Trial

    International Nuclear Information System (INIS)

    Purpose: To report the 5-year results of a randomized study comparing the survival and cosmetic results of breast-conserving treatment with partial breast irradiation (PBI) or conventional whole breast irradiation (WBI). Methods and Materials: Between 1998 and 2004, 258 selected patients with T1 N0-1mi, Grade 1-2, nonlobular breast cancer without presence of extensive intraductal component and resected with negative margins were randomized after breast-conserving surgery to receive 50 Gy/25 fractions WBI (n = 130) or PBI (n = 128). The latter consisted of either 7 x 5.2 Gy high-dose-rate (HDR) multicatheter brachytherapy (BT; n = 88) or 50 Gy/25 fractions electron beam (EB) irradiation (n = 40). Results: At a median follow-up of 66 months, the 5-year actuarial rate of local recurrence was 4.7% and 3.4% in the PBI and WBI arms, respectively (p = 0.50). There was no significant difference in the 5-year probability of overall survival (94.6% vs. 91.8%), cancer-specific survival (98.3% vs. 96.0%), and disease-free survival (88.3% vs. 90.3%). The rate of excellent to good cosmetic result was 77.6% in the PBI group (81.2% after HDR BT; 70.0% after EB) and 62.9% in the control group (52.2% after telecobalt; 65.6% after 6-9-MV photons; pWBI/PBI = 0.009). Conclusions: Partial breast irradiation using interstitial HDR implants or EB to deliver radiation to the tumor bed alone for a selected group of early-stage breast cancer patients produces 5-year results similar to those achieved with conventional WBI. Significantly better cosmetic outcome can be achieved with carefully designed HDR multicatheter implants compared with the outcome after WBI

  11. Deinstitutionalization revisited: a 5-year follow-up of a randomized clinical trial of hospital-based rehabilitation versus specialized assertive intervention (OPUS) versus standard treatment for patients with first-episode schizophrenia spectrum disorders

    DEFF Research Database (Denmark)

    Nordentoft, Merete; Øhlenschlæger, Johan; Thorup, Anne Amalie Elgaard;

    2010-01-01

    in a special part of the Copenhagen OPUS trial and randomized to either the specialized assertive intervention program (OPUS), standard treatment or hospital-based rehabilitation. RESULTS: It was a stable pattern that patients randomized to hospital-based rehabilitation spent more days in psychiatric wards...... and in supported housing throughout the 5-year follow-up period compared with the two other groups. Patients in OPUS treatment spent significantly fewer days in psychiatric wards and supported housing in the first 3 years compared with patients in hospital-based rehabilitation. Due to attrition and small sample...... size, differences in level of psychotic and negative symptoms at 5-year follow-up could not be evaluated. CONCLUSIONS: The study indicates that hospital-based rehabilitation together with weekly supportive psychodynamic therapy was associated with a continued increased use of psychiatric bed days...

  12. Care and Aftercare Related to Implant-Retained Dental Crowns in the Maxillary Aesthetic Region : A 5-Year Prospective Randomized Clinical Trial

    NARCIS (Netherlands)

    Visser, Anita; Raghoebar, Gerry M.; Meijer, Henny J. A.; Meijndert, Leo; Vissink, Arjan

    2011-01-01

    Aim: To prospectively assess surgical and prosthetic care and aftercare related to the placement of implant-retained dental crowns after local bone augmentation in patients missing one tooth in the maxillary aesthetic region. Methods: Ninety-three patients were randomly allocated to one of three loc

  13. Deinstitutionalization revisited: a 5-year follow-up of a randomized clinical trial of hospital-based rehabilitation versus specialized assertive intervention (OPUS) versus standard treatment for patients with first-episode schizophrenia spectrum disorders

    DEFF Research Database (Denmark)

    Nordentoft, Merete; Øhlenschlæger, Johan; Thorup, Anne Amalie Elgaard;

    2010-01-01

    in a special part of the Copenhagen OPUS trial and randomized to either the specialized assertive intervention program (OPUS), standard treatment or hospital-based rehabilitation. RESULTS: It was a stable pattern that patients randomized to hospital-based rehabilitation spent more days in psychiatric wards......BACKGROUND: The effects of hospital-based rehabilitation including weekly supportive psychodynamic therapy compared with specialized assertive intervention and standard treatment has not previously been investigated in first-episode psychosis. The aim of the study was to examine long-term effect...... and in supported housing throughout the 5-year follow-up period compared with the two other groups. Patients in OPUS treatment spent significantly fewer days in psychiatric wards and supported housing in the first 3 years compared with patients in hospital-based rehabilitation. Due to attrition and small sample...

  14. 5-Year Clinical Outcomes in the ICTUS (Invasive versus Conservative Treatment in Unstable coronary Syndromes) Trial A Randomized Comparison of an Early Invasive Versus Selective Invasive Management in Patients With Non-ST-Elevation Acute Coronary Syndrome

    NARCIS (Netherlands)

    P. Damman; A. Hirsch; F. Windhausen; J.G.P. Tijssen; R.J. de Winter

    2010-01-01

    OBJECTIVES: We present the 5-year clinical outcomes according to treatment strategy with additional risk stratification of the ICTUS (Invasive versus Conservative Treatment in Unstable coronary Syndromes) trial. BACKGROUND: Long-term outcomes may be relevant to decide treatment strategy for patients

  15. Final 5-Year Follow-Up of a Randomized Controlled Trial of Everolimus- and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice the COMPARE Trial (A Trial of Everolimus-Eluting Stents and Paclitaxel Stents for Coronary Revascularization in Daily Practice)

    NARCIS (Netherlands)

    P.C. Smits (Pieter); G.J. Vlachojannis (Georgios J.); E.P. McFadden (Eugene); K.-J. Royaards; J. Wassing (Jochem); K.S. Joesoef; C.A.G. van Mieghem (Carlos); M. van der Ent (Martin)

    2015-01-01

    textabstractObjectives This study sought to report the 5-year outcomes of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in an all-comers population undergoing percutaneous coronary intervention (PCI). Background The medium-term 1 and 2-year results of the prospective randomized

  16. Hormone replacement therapy dissociates fat mass and bone mass, and tends to reduce weight gain in early postmenopausal women: a randomized controlled 5-year clinical trial of the Danish Osteoporosis Prevention Study

    DEFF Research Database (Denmark)

    Jensen, L B; Vestergaard, P; Hermann, A P;

    2003-01-01

    The aim of this study was to study the influence of hormone replacement therapy (HRT) on weight changes, body composition, and bone mass in early postmenopausal women in a partly randomized comprehensive cohort study design. A total of 2016 women ages 45-58 years from 3 months to 2 years past last...... in women randomized to HRT (1.94 +/- 4.86 kg) than in women randomized to no HRT (2.57 +/- 4.63, p = 0.046). A similar pattern was seen in the group receiving HRT or not by their own choice. The smaller weight gain in women on HRT was almost entirely caused by a lesser gain in fat. The main determinant...... of the weight gain was a decline in physical fitness. Women opting for HRT had a significantly lower body weight at inclusion than the other participants, but the results in the self-selected part of the study followed the pattern found in the randomized part. The change in fat mass was the strongest predictor...

  17. Two consecutive randomized controlled pertussis booster trials in children initially vaccinated in infancy with an acellular vaccine: The first with a five-component Tdap vaccine to 5-year olds and the second with five- or monocomponent Tdap vaccines at age 14-15 years.

    Science.gov (United States)

    Carlsson, R M; Gustafsson, L; Hallander, H O; Ljungman, M; Olin, P; Gothefors, L; Nilsson, L; Netterlid, E

    2015-07-17

    Prior study children from a DTaP efficacy trial were recruited at ages 5 and 15 years to randomized booster trials addressing immunogenicity and reactogenicity; 475 preschool children received mixed or separate injections of a reduced antigen vaccine (Tdap5, Sanofi Pasteur MSD) and an inactivated polio vaccine, and 230 adolescents received the same or another booster vaccine (Tdap1, SSI, Denmark). Pre-vaccination antibody concentrations against pertussis antigens were significantly higher at 15 than 5 years of age, probably due to natural boosting between the studies. Tdap5 induced comparable anti-PT concentrations at both ages, but antibody responses were significantly higher to filamentous haemagglutinin, pertactin and fimbriae 2/3 in adolescents. As expected, a higher amount of PT (Tdap1, 20μg) induced a stronger anti-PT response than a lower amount (Tdap5, 2.5μg). The frequency of adverse events was low and there were no serious adverse reactions. All local reactions had an early onset and a short duration. A large swelling or redness of more than half of the upper arm circumference was reported in 8/475 5-year-olds and in 6/230 15-year-olds. Children vaccinated with Tdap5 reported more moderate pain in adolescence than at preschool age, whereas itching was only reported in preschool children. Sweden introduced DTaP vaccines in 1996 after a 17-year hiatus with no general pertussis vaccination and pertussis was still endemic at the time of the studies. The frequency of adverse events was nevertheless low in both preschool children and adolescents and antibody responses were adequate. These studies document immunogenicity and reactogenicity in a trial cohort consecutively vaccinated with acellular pertussis vaccines from infancy to adolescence. The adolescent study was registered at ClinicalTrials.gov on 26 March 2009 (NCT00870350).

  18. Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial.

    OpenAIRE

    Thomson, NC; Rubin, AS; Niven, RM; Corris, PA; Siersted, HC; Olivenstein, R.; Pavord, ID; McCormack, D.; Laviolette, M.; Shargill, NS; Cox, G.

    2011-01-01

    BACKGROUND: Bronchial thermoplasty (BT) is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure. METHODS: Patients enrolled in the Asthma Intervention Research Trial were on inhaled corticosteroids ≥200 μg beclomethasone or equivalent + long-acting-beta2-agonists and demonstrated worsening of asthma on long-acting-β2-agonist withdrawal. Following initial...

  19. Long term (5 Year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial

    OpenAIRE

    Thomson, N C; Rubin, A.S.; Niven, R. M.; Corris, P A; Siersted, H. C.; Olivenstein, R.; Pavord, I.D.; McCormick, D.; Laviolette, M.; Shargill, N.S.; Cox, G.

    2011-01-01

    Background: Bronchial thermoplasty (BT) is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure. Methods: Patients enrolled in the Asthma Intervention Research Trial were on inhaled corticosteroids ≥200 μg beclomethasone or equivalent + long-acting-beta2-agonists and demonstrated worsening of asthma on long-acting-β2-agonist withdrawal. ...

  20. a randomized, controlled trial

    OpenAIRE

    Reinecke, Franziska

    2010-01-01

    The polycystic ovarian syndrome (PCOS) is characterized by hyperandrogenism and associated with obesity and impaired glucose metabolism. Despite the high prevalence of PCOS and the considerable clinical impact, the precise interplay between metabolism and hyperandrogenemia is not entirely clear. To analyse the effects of intravenous lipid and heparin infusion on circulating androgen levels in healthy women, we performed a randomized controlled cross-over trial. 12 healthy young women durin...

  1. Percutaneous coronary intervention in the Occluded Artery Trial: Procedural success, hazard, and outcomes over 5 years

    OpenAIRE

    Buller, C; Rankin, J.; Carere, R; P. Buszman; Pfisterer, M.; Dzavik, V; Thomas, B.; Forman, S.; Ruzyllo, W; Mancini, G.; Michalis, L; de Abreu, G.; Lamas, G.; Hochman, J

    2009-01-01

    BACKGROUND: The Occluded Artery Trial (OAT) was a 2,201-patient randomized clinical trial comparing routine stent-based percutaneous coronary intervention (PCI) versus optimal medical therapy alone in stable myocardial infarction (MI) survivors with persistent infarct-related artery occlusion identified day 3 to 28 post MI. Intent-to-treat analysis showed no difference between strategies with respect to the incidence of new class IV congestive heart failure, MI, or death. The influence of PCI...

  2. Docetaxel- and 5-FU-concurrent radiotherapy in patients presenting unresectable locally advanced pancreatic cancer: a FNCLCC-ACCORD/0201 randomized phase II trial's pre-planned analysis and case report of a 5.5-year disease-free survival

    Directory of Open Access Journals (Sweden)

    Peiffert Didier

    2011-09-01

    Full Text Available Abstract Background To explore possible improvement in the treatment of locally advanced pancreatic carcinoma (LAPC we performed a randomized, non-comparative phase II study evaluating docetaxel - plus either daily continuous 5 FU or weekly cisplatin concurrent to radiotherapy. We report here the results of the docetaxel plus 5 FU regimen stopped according to the interim analysis. The docetaxel plus cisplatin arm was continued. Methods Forty (40 chemotherapy-naive patients with unresectable LAPC were randomly assigned (1:1 to either continuous fluorouracil (5-FU 200 mg/m2/day (protracted IV and docetaxel (DCT 20 mg/m2/week or DCT 20 mg/m2 and cisplatin (CDDP 20 mg/m2, plus concurrent radiotherapy for a period of 6 weeks. The radiation dose to the primary tumor was 54 Gy in 30 fractions. The trial's primary endpoint was the 6-month crude non-progression rate (NPR. Secondary endpoints were tolerance, objective response rate, and overall survival. Accrual was to be stopped if at 6 months more than 13 disease progressions were observed in 20 patients. Results Eighteen (18 progressions occurred at 6 months in the 5-FU-DCT arm. Six-month NPR was 10% (95%CI: 0-23. Six and 12-month survivals were 85% (95%CI: 64-95 and 40% (95%CI: 22-61; median overall survival was 10.1 months. Median progression-free survival was 4.3 months. We report the case of one patient who was amenable to surgery and has been in complete response (CR for 5.5 years. Toxicities grade ≥ 3 were reported in 75% of patients; no treatment-related death occurred. Severe toxicities were mainly vomiting (35%, abdominal pain (10% and fatigue (10%. Conclusions Combination of 5-FU, docetaxel and radiotherapy has inadequate efficacy in the treatment of LAPC despite good tolerance for the 5-FU-DCT regimen. Trial Registration ClinicalTrials.gov: NCT00112697

  3. Traditional endodontic surgery versus modern technique: a 5-year controlled clinical trial.

    Science.gov (United States)

    Tortorici, Silvia; Difalco, Paolo; Caradonna, Luigi; Tetè, Stefano

    2014-05-01

    In this study, we compared outcomes of traditional apicoectomy versus modern apicoectomy, by means of a controlled clinical trial with a 5-year follow-up. The study investigated 938 teeth in 843 patients. On the basis of the procedure performed, the teeth were grouped in 3 groups. Differences between the groups were the method of osteotomy (type of instruments used), type of preparation of retrograde cavity (different apicoectomy angles and instruments used for root-end preparation), and root-end filling material used (gray mineral trioxide aggregate or silver amalgam). Outcome (tooth healing) was estimated after 1 and 5 years, postoperatively. Clinical success rates after 1 year were 67% (306 teeth), 90% (186 teeth), and 94% (256 teeth) according to traditional apicoectomy (group 1), modern microsurgical apicoectomy using burns for osteotomy (group 2) or using piezo-osteotomy (group 3), respectively. After 1 year, group comparison results were statistically significant (P apicoectomy resulted in a probability of success more than 5 times higher (odds ratio, 5.20 [95% confidence interval, 3.94-6.92]; P < 0.001) compared with the traditional technique. PMID:24469371

  4. Posterior bulk-filled resin composite restorations. A 5-year randomized controlled clinical study

    DEFF Research Database (Denmark)

    van Dijken, Jan WV; Pallesen, Ulla

    2016-01-01

    Objective: To evaluate in a randomized controlled study the 5-year clinical durability of a flowable resin composite bulk-fill technique in Class I and Class II restorations. Material and methods: 38 pairs Class I and 62 pairs Class II restorations were placed in 44 male and 42 female (mean age 52.......4 years). Each patient received at least two, as similar as possible, extended Class I or Class II restorations. In all cavities, a 1-step self-etch adhesive (Xeno V+) was applied. Randomized, one of the cavities of each pair received the flowable bulk-filled resin composite (SDR), in increments up to 4mm...... as needed to fill the cavity 2mm short of the occlusal cavosurface. The occlusal part was completed with the ormocer-based nano-hybrid resin composite (Ceram X mono+). In the other cavity, the resin composite-only (Ceram X mono+) was placed in 2mm increments. The restorations were evaluated using slightly...

  5. Posterior bulk-filled resin composite restorations. A 5-year randomized controlled clinical study

    DEFF Research Database (Denmark)

    Dijken, Jan WVvan; Pallesen, Ulla

    2016-01-01

    OBJECTIVE: To evaluate in a randomized controlled study the 5-year clinical durability of a flowable resin composite bulk-fill technique in Class I and Class II restorations. MATERIAL AND METHODS: 38 pairs Class I and 62 pairs Class II restorations were placed in 44 male and 42 female (mean age 52.......4 years). Each patient received at least two, as similar as possible, extended Class I or Class II restorations. In all cavities, a 1-step self-etch adhesive (Xeno V+) was applied. Randomized, one of the cavities of each pair received the flowable bulk-filled resin composite (SDR), in increments up to 4mm...... as needed to fill the cavity 2mm short of the occlusal cavosurface. The occlusal part was completed with the nano-hybrid resin composite (Ceram X mono+). In the other cavity, the resin composite-only (Ceram X mono+) was placed in 2mm increments. The restorations were evaluated using slightly modified USPHS...

  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...

  7. 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...

  8. Final screening round of the NELSON lung cancer screening trial : the effect of a 2.5-year screening interval

    NARCIS (Netherlands)

    Yousaf-Khan, Uraujh; van der Aalst, Carlijn; de Jong, Pim A; Heuvelmans, Marjolein; Scholten, Ernst; Lammers, Jan-Willem; van Ooijen, Peter; Nackaerts, Kristiaan; Weenink, Carla; Groen, Harry; Vliegenthart, Rozemarijn; Ten Haaf, Kevin; Oudkerk, Matthijs; de Koning, Harry

    2016-01-01

    BACKGROUND: In the USA annual lung cancer screening is recommended. However, the optimal screening strategy (eg, screening interval, screening rounds) is unknown. This study provides results of the fourth screening round after a 2.5-year interval in the Dutch-Belgian Lung Cancer Screening trial (NEL

  9. Intranasal LH-RH treatment of cryptorchidism. A clinical trial and 5 years follow-up

    DEFF Research Database (Denmark)

    Thorup, Jørgen Mogens; Mauritzen, K; Skakkebaek, N E

    1987-01-01

    The effect of intranasal LH-RH on cryptorchidism was investigated in 45 prepubertal boys with 68 undescended testes. A daily dose of 1.2 mg LH-RH was given for 4 weeks. A total of 16 testes (24%) descended. Follow-up examination 5 years later showed that relapse had occurred in two cases. Fifty-t...

  10. Impact of extended lymphadenectomy on morbidity, mortality, recurrence and 5-year survival after gastrectomy for cancer: meta-analysis of randomized clinical trials Impacto da linfadenectomia ampliada na morbidade, mortalidade, recidiva e cinco anos de sobrevida após gastrectomia por câncer: metanálise de ensaios clínicos randomizados

    Directory of Open Access Journals (Sweden)

    Suzana Angélica Silva Lustosa

    2008-12-01

    Full Text Available PURPOSE: To compare morbidity, mortality, recurrence and 5-year survival between D1 and D2 or D3 for treatment of gastric cancer. METHODS: Systematic review and meta-analysis of RCTs. Metaview in RevMan 4.2.8 for analysis; statistical heterogeneity by Cochran's Q test (P50%. Estimates of effect were calculated using random effects model. RESULTS: D2 or D3 was associated with higher in-hospital mortality, with RR = 2.13, p=0.0004, 95% CI, 1.40 to 3.25, I²=0%, P=0.63; overall morbidity showed higher incidence in D2 or D3, RR = 1.98, pOBJETIVO: Comparar a morbidade, mortalidade, recidiva e sobrevida de cinco anos entre linfadenectomia D1 e D2 ou D3 no tratamento do câncer gástrico. MÉTODOS: Revisão sistemática metanálise de ensaios clínicos randomizados, programa Metaview, Revman 4.2.8. Heterogeneidade estatística pelo teste Q de Cochrane (P50%. Estimativas dos efeitos pelo modelo randômico. RESULTADOS: Maior mortalidade hospitalar em D2 ou D3, RR = 2.13, p=0.0004, 95% IC, 1.40 a 3.25, I²=0%, P=0.63; maior morbidade geral em D2 ou D3, RR = 1.98, p<0.00001, 95% IC, 1.64 a 2.38, I² = 33.9%, P=0.20; maior tempo operatório em D2 e D3, diferença de média ponderal de 1.05, p<0.00001, 95% IC, 0.71 a 1.38, I² = 78.7%, P=0.03; número de reoperações maior em D2 e D3, RR = 2.33, p<0.0001, 95% IC, 1.58 a 3.44, I² = 0%, P=0.99; maior tempo de permanência hospitalar em D2 e D3, diferença de média ponderal de 4.72, p<0.00001, 95% IC, 3.80 a 5.65, I² = 89.9%, P<0.00001; recidiva maior nos grupos D2 e D3, RR = 0.89, p=0.02, 95% IC, 0.80 a 0.98, I² = 71.0%, P = 0.03; mortalidade com doença recidivada maior em D1, RR = 0.88, p=0.04, 95% IC, 0.78 a 0.99, I² =51.8%, P=0.10; 5 anos de sobrevida mostrou diferença estatística não significante, RR = 1.05, p=0.40, 95% IC, 0.93 a 1.19, I² = 49.1% e P=0.12. CONCLUSÕES: Linfadenectomia D2 ou D3 está associada a maior morbidade e maior mortalidade intra-hospitalar; D2 ou D3 apresenta menor incid

  11. Fluorouracil Based Chemoradiation with Either Gemcitabine or Fluorouracil Chemotherapy Following Resection of Pancreatic Adenocarcinoma: 5-Year Analysis of the US Intergroup/RTOG 9704 Phase III Trial

    Science.gov (United States)

    Regine, William F.; Winter, K.A.; Abrams, R.; Safran, H.; Hoffman, J.P.; Konski, A.; Benson, A.B.; Macdonald, J.S.; Rich, T.A.; Willett, C.G.

    2011-01-01

    Background The impact of the addition of gemcitabine (G) to 5-FU chemoradiation (CRT) on 5-year overall survival (OS) in resected pancreatic adenocarcinoma are presented with updated results of a phase III trial. Methods Following resection of pancreatic adenocarcinoma patients were randomized to pre and post CRT 5-FU vs. pre and post CRT G. 5-FU = continuous (CI) at 250 mg/m2/day. G = 1000 mg/m2 weekly; both given over 3 weeks pre and 12 weeks post - CRT. CRT = 50.4 Gy with CI 5-FU. Primary endpoint was survival for all patients and for pancreatic head tumor patients. Results Four hundred and fifty-one patients were eligible. Univariate analysis showed no difference in OS. Pancreatic head tumor patients (n=388) had a median survival and 5-year OS of 20.5 months and 22% with G vs. 17.1 months and 18% with 5-FU. On multivariate analysis, patients on the G arm with pancreatic head tumors experienced a trend towards improved OS (p=0.08). First site of relapse local recurrence in 28% of patients vs. distant relapse in 73%. Conclusion(s) The sequencing of 5-FU CRT with G as done in this trial is not associated with a statistically significant improvement in OS. Despite local recurrence being approximately half of that reported in previous adjuvant trials, distant disease relapse still occurs in ≥ 70% of patients. These findings serve as the basis for the recently activated EORTC/US Intergroup RTOG 0848 phase III adjuvant trial evaluating the impact of CRT after completion of a full course of G. PMID:21499862

  12. The Design of Cluster Randomized Crossover Trials

    Science.gov (United States)

    Rietbergen, Charlotte; Moerbeek, Mirjam

    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 control. In a CR CO trial, clusters of subjects…

  13. A cluster randomised trial to evaluate a physical activity intervention among 3-5 year old children attending long day care services: study protocol

    Directory of Open Access Journals (Sweden)

    Finch Meghan

    2010-09-01

    Full Text Available Abstract Background Young children are not participating in recommended levels of physical activity and exhibit high levels of sedentary behaviour. Childcare services provide access to large numbers of young children for prolonged periods, yet there is limited experimental evidence regarding the effectiveness of physical activity interventions implemented in this setting. The aim of this study is to assess the effectiveness and acceptability of a multi-component physical activity intervention, delivered by childcare service staff, in increasing the physical activity levels of children attending long day care services. Methods/Design The study will employ a cluster randomised controlled trial design. Three hundred children aged between 3-5 years from twenty randomly selected long day care services in the Hunter Region of New South Wales, Australia will be invited to participate in the trial. Ten of the 20 long day care services will be randomly allocated to deliver the intervention with the remaining ten services allocated to a wait list control group. The physical activity intervention will consist of a number of strategies including: delivering structured fundamental movement skill activities, increasing physical activity opportunities, increasing staff role modelling, providing children with a physical activity promoting indoor and outdoor environment and limiting children's small screen recreation and sedentary behaviours. Intervention effectiveness will be measured via child physical activity levels during attendance at long day care. The study also seeks to determine the acceptability and extent of implementation of the intervention by services and their staff participating in the study. Discussion The trial will address current gaps in the research evidence base and contribute to the design and delivery of future interventions promoting physical activity for young children in long day care settings. Trial registration Australian New

  14. 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...... variable. Generation of trial databases and/or biobanks originating in large randomized clinical trials has successfully increased the knowledge obtained from those trials. At the 10th Cardiovascular Trialist Workshop, possibilities and pitfalls in designing and accessing clinical trial databases were...

  15. Effects of a Randomized Reading Intervention Study Aimed at 9-Year-Olds: A 5-Year Follow-up.

    Science.gov (United States)

    Wolff, Ulrika

    2016-05-01

    The present paper reports on a 5-year follow-up of a randomized reading intervention in grade 3 in Sweden. An intervention group (n = 57) received daily training for 12 weeks in phoneme/grapheme mapping, reading comprehension and reading speed, whereas a control group (n = 55) participated in ordinary classroom activities. The main aim was to investigate if there were remaining effects of the intervention on reading-related skills. Previous analyses showed that the intervention group performed significantly better than the control group on spelling, reading speed, reading comprehension and phoneme awareness at the immediate post-test with sustained effects 1 year later. Results from the 5-year follow-up show that the only significant difference between the intervention (n = 47) and the control group (n = 37) was on word decoding. There was also a significant interaction effect of group assignment and initial word decoding, in the way that the lowest-performing students benefitted the most from the intervention. Another aim was to examine if the children identified in a screening (n = 2212) as poor readers in grade 2 still performed worse than typical readers. The analyses showed that the typically developing students (n = 66) outperformed the students identified as poor readers in grade 2 on working memory, spelling, reading comprehension and word decoding. Copyright © 2016 John Wiley & Sons, Ltd. PMID:27146373

  16. Function: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Shakuri Seyed Kazem

    2015-03-01

    Full Text Available Introduction: Prevention of pulmonary complications after coronary artery bypass graft is attended as a very important issue. The aim of this study was to evaluate the role of pulmonary rehabilitation before surgery for reducing the risk of pulmonary complications after surgery. Methods: In a randomized clinical trial, 60 patients undergoing heart surgery were randomly divided into two groups A and B. Chest physiotherapy was performed before and after surgery on group A patients however it was done on group B’s, only after surgery. Effects of preoperative pulmonary rehabilitation were compared between two groups, using spirometry and arterial blood gas (ABG. Results: Thirty nine males (65% and 21 females (35% with mean age of 8.10 ± 9.56 were analyzed.The mean differences were statistically significant for predicted forced vital capacity (FVC (CI95%:1.3 to 8.7 and Predicted Peak Flow indices (PEF (CI 95%: 1.9 to 9.4 of spirometry indicator,PCO2 index (of ABG parameter (CI 95%: 1.4 to 8.9 and mean oxygen saturation (mean Spo2 (CI 95%: 0.6 to 1.7 of ABG index in two groups. Conclusion: The performance of pulmonary rehabilitation program before surgery is recommended, as it may result in the reduction of complications of heart surgery.

  17. Radiographic Progression of Patients With Psoriatic Arthritis Who Achieve Minimal Disease Activity in Response to Golimumab Therapy: Results Through 5 Years of a Randomized, Placebo‐Controlled Study

    Science.gov (United States)

    van der Heijde, Désirée; Beutler, Anna; Gladman, Dafna; Mease, Philip; Krueger, Gerald G.; McInnes, Iain B.; Helliwell, Philip; Coates, Laura C.; Xu, Stephen

    2016-01-01

    Objective To evaluate long‐term outcomes in psoriatic arthritis (PsA) patients who achieved or did not achieve minimal disease activity (MDA) through 5 years of golimumab treatment in the GO‐REVEAL trial. Methods The GO‐REVEAL trial was a phase III, randomized, double‐blind trial with placebo‐control through week 24 followed by an open‐label extension of golimumab 50/100 mg treatment up to 5 years. In these post‐hoc analyses, MDA was defined by the presence of ≥5 of 7 PsA outcome measures (≤1 swollen joint, ≤1 tender joint, Psoriasis Area and Severity Index [PASI] ≤1, patient pain score ≤15, patient global disease activity score ≤20 [range 0–100], Health Assessment Questionnaire disability index [HAQ DI] ≤0.5, and ≤1 tender enthesis point). Results Treatment with golimumab yielded significantly higher MDA response rates versus patients randomized to placebo at week 14 (23.5% versus 1.0%; P golimumab‐treated patients overall. Irrespective of treatment randomization, achievement of MDA at ≥3 and ≥4 consecutive visits was associated with significantly less radiographic progression and more improvement in MDA components allowing specific assessment of physical function (HAQ DI) and overall disease activity (patient global assessment of disease activity) at week 256 versus patients not achieving MDA. Logistic regression analyses indicated that a 1‐unit higher baseline HAQ DI score yielded a significantly lower likelihood of achieving MDA at ≥3 (odds ratio 0.514 [95% confidence interval 0.321–0.824]; P = 0.006) and ≥4 (odds ratio 0.480 [95% confidence interval 0.290–0.795]; P = 0.004) consecutive visits. Conclusion Among golimumab‐treated PsA patients, better long‐term functional improvement, patient global assessment, and radiographic outcomes were observed when patients achieved persistent MDA. PMID:25779603

  18. AntiPhospholipid Syndrome Alliance for Clinical Trials and InternatiOnal Networking (APS ACTION): 5-Year Update.

    Science.gov (United States)

    Barbhaiya, Medha; Andrade, Danieli; Erkan, Doruk

    2016-10-01

    Antiphospholipid Syndrome Alliance for Clinical Trials and International Networking (APS ACTION) is the first-ever international network created to design and conduct large-scale, multicenter clinical trials and research in persistently antiphospholipid antibody (aPL)-positive patients. Since its inception in 2010, the APS ACTION has made important strides toward our goal of international research collaboration and data sharing. Through the dedication and hard work of 50 APS ACTION members, collaborative international projects are currently underway including a multicenter web-based registry and repository of aPL-positive patients, a randomized controlled clinical trial assessing the efficacy of hydroxychloroquine for primary thrombosis prevention in persistently aPL-positive but thrombosis-free patients, standardization of aPL testing through the use of core laboratories worldwide, identification of the limitations in the existing aPL/APS literature, and conducting observational research studies to further our understanding of the disease. Thus far, APS ACTION has held annual workshops and summits with the aim of facilitating international collaboration and developing initiatives to recruit young scholars to APS research. This paper describes updates related to the organization's structure, ongoing research efforts, and recent accomplishments and discusses future directions. PMID:27646150

  19. 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...... variable. Generation of trial databases and/or biobanks originating in large randomized clinical trials has successfully increased the knowledge obtained from those trials. At the 10th Cardiovascular Trialist Workshop, possibilities and pitfalls in designing and accessing clinical trial databases were......, 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...

  20. 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

  1. Randomization in clinical trials: conclusions and recommendations.

    Science.gov (United States)

    Lachin, J M; Matts, J P; Wei, L J

    1988-12-01

    The statistical properties of simple (complete) randomization, permuted-block (or simply blocked) randomization, and the urn adaptive biased-coin randomization are summarized. These procedures are contrasted to covariate adaptive procedures such as minimization and to response adaptive procedures such as the play-the-winner rule. General recommendations are offered regarding the use of complete, permuted-block, or urn randomization. In a large double-masked trial, any of these procedures may be acceptable. For a given trial, the relative merits of each procedure should be carefully weighed in relation to the characteristics of the trial. Important considerations are the size of the trial, overall as well as within the smallest subgroup to be employed in a subgroup-specific analysis, whether or not the trial is to be masked, and the resources needed to perform the proper randomization-based permutational analysis. PMID:3203526

  2. Randomization in substance abuse clinical trials

    OpenAIRE

    Woolson Robert F; Hedden Sarra L; Malcolm Robert J

    2006-01-01

    Abstract Background A well designed randomized clinical trial rates as the highest level of evidence for a particular intervention's efficacy. Randomization, a fundamental feature of clinical trials design, is a process invoking the use of probability to assign treatment interventions to patients. In general, randomization techniques pursue the goal of providing objectivity to the assignment of treatments, while at the same time balancing for treatment assignment totals and covariate distribu...

  3. 'Be active, eat right', evaluation of an overweight prevention protocol among 5-year-old children: design of a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Veldhuis Lydian

    2009-06-01

    Full Text Available Abstract Background The prevalence of overweight and obesity in children has at least doubled in the past 25 years with a major impact on health. In 2005 a prevention protocol was developed applicable within Youth Health Care. This study aims to assess the effects of this protocol on prevalence of overweight and health behaviour among children. Methods and design A cluster randomised controlled trial is conducted among 5-year-old children included by 44 Youth Health Care teams randomised within 9 Municipal Health Services. The teams are randomly allocated to the intervention or control group. The teams measure the weight and height of all children. When a child in the intervention group is detected with overweight according to the international age and gender specific cut-off points of BMI, the prevention protocol is applied. According to this protocol parents of overweight children are invited for up to three counselling sessions during which they receive personal advice about a healthy lifestyle, and are motivated for and assisted in behavioural change. The primary outcome measures are Body Mass Index and waist circumference of the children. Parents will complete questionnaires to assess secondary outcome measures: levels of overweight inducing/reducing behaviours (i.e. being physically active, having breakfast, drinking sweet beverages and watching television/playing computer games, parenting styles, parenting practices, and attitudes of parents regarding these behaviours, health-related quality of life of the children, and possible negative side effects of the prevention protocol. Data will be collected at baseline (when the children are aged 5 years, and after 12 and 24 months of follow-up. Additionally, a process and a cost-effectiveness evaluation will be conducted. Discussion In this study called 'Be active, eat right' we evaluate an overweight prevention protocol for use in the setting of Youth Health Care. It is hypothesized that the

  4. 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...

  5. 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...

  6. Implant-supported mandibular overdentures retained with ball or bar attachments: a randomized prospective 5-year study

    DEFF Research Database (Denmark)

    Gotfredsen, K; Holm, B

    2001-01-01

    pocket depth were assessed around each implant. Periotest values were recorded, and periodically identical intraoral radiographs were obtained with a specially designed film-holding device. RESULTS: No implants were lost from baseline to the 5-year registration. The periimplant conditions were very...

  7. Random allocation software for parallel group randomized trials

    Directory of Open Access Journals (Sweden)

    Saghaei Mahmood

    2004-11-01

    Full Text Available Abstract Background Typically, randomization software should allow users to exert control over the different aspects of randomization including block design, provision of unique identifiers and control over the format and type of program output. While some of these characteristics have been addressed by available software, none of them have all of these capabilities integrated into one package. The main objective of the Random Allocation Software project was to enhance the user's control over different aspects of randomization in parallel group trials, including output type and format, structure and ordering of generated unique identifiers and enabling users to specify group names for more than two groups. Results The program has different settings for: simple and blocked randomizations; length, format and ordering of generated unique identifiers; type and format of program output; and saving sessions for future use. A formatted random list generated by this program can be used directly (without further formatting by the coordinator of the research team to prepare and encode different drugs or instruments necessary for the parallel group trial. Conclusions Random Allocation Software enables users to control different attributes of the random allocation sequence and produce qualified lists for parallel group trials.

  8. The DAHANCA 6 randomized trial

    DEFF Research Database (Denmark)

    Lyhne, Nina M; Primdahl, Hanne; Kristensen, Claus A;

    2015-01-01

    explored. PATIENTS AND METHODS: Six hundred and ninety-four patients with non-metastatic glottic SCC were randomized between six or five weekly fractions (fx/w) of radiotherapy to the same total dose. The median treatment time was 38 and 46days, respectively. The primary endpoint was loco-regional failure...

  9. Bone fractures among postmenopausal patients with endocrine-responsive early breast cancer treated with 5 years of letrozole or tamoxifen in the BIG 1-98 trial

    DEFF Research Database (Denmark)

    Rabaglio, M; Sun, Z; Price, K N;

    2009-01-01

    BACKGROUND: To compare the incidence and timing of bone fractures in postmenopausal women treated with 5 years of adjuvant tamoxifen or letrozole for endocrine-responsive early breast cancer in the Breast International Group (BIG) 1-98 trial. METHODS: We evaluated 4895 patients allocated to 5 years...... of letrozole or tamoxifen in the BIG 1-98 trial who received at least some study medication (median follow-up 60.3 months). Bone fracture information (grade, cause, site) was collected every 6 months during trial treatment. RESULTS: The incidence of bone fractures was higher among patients treated...... with letrozole [228 of 2448 women (9.3%)] versus tamoxifen [160 of 2447 women (6.5%)]. The wrist was the most common site of fracture in both treatment groups. Statistically significant risk factors for bone fractures during treatment included age, smoking history, osteoporosis at baseline, previous bone...

  10. Randomization in substance abuse clinical trials

    Directory of Open Access Journals (Sweden)

    Woolson Robert F

    2006-02-01

    Full Text Available Abstract Background A well designed randomized clinical trial rates as the highest level of evidence for a particular intervention's efficacy. Randomization, a fundamental feature of clinical trials design, is a process invoking the use of probability to assign treatment interventions to patients. In general, randomization techniques pursue the goal of providing objectivity to the assignment of treatments, while at the same time balancing for treatment assignment totals and covariate distributions. Numerous randomization techniques, each with varying properties of randomness and balance, are suggested in the statistical literature. This paper reviews common randomization techniques often used in substance abuse research and an application from a National Institute on Drug Abuse (NIDA-funded clinical trial in substance abuse is used to illustrate several choices an investigator faces when designing a clinical trial. Results Comparisons and contrasts of randomization schemes are provided with respect to deterministic and balancing properties. Specifically, Monte Carlo simulation is used to explore the balancing nature of randomization techniques for moderately sized clinical trials. Results demonstrate large treatment imbalance for complete randomization with less imbalance for the urn or adaptive scheme. The urn and adaptive randomization methods display smaller treatment imbalance as demonstrated by the low variability of treatment allocation imbalance. For all randomization schemes, covariate imbalance between treatment arms was small with little variation between adaptive schemes, stratified schemes and unstratified schemes given that sample sizes were moderate to large. Conclusion We develop this paper with the goal of reminding substance abuse researchers of the broad array of randomization options available for clinical trial designs. There may be too quick a tendency for substance abuse researchers to implement the fashionable urn

  11. Clinical Research Methodology 3: Randomized Controlled Trials.

    Science.gov (United States)

    Sessler, Daniel I; Imrey, Peter B

    2015-10-01

    Randomized assignment of treatment excludes reverse causation and selection bias and, in sufficiently large studies, effectively prevents confounding. Well-implemented blinding prevents measurement bias. Studies that include these protections are called randomized, blinded clinical trials and, when conducted with sufficient numbers of patients, provide the most valid results. Although conceptually straightforward, design of clinical trials requires thoughtful trade-offs among competing approaches-all of which influence the number of patients required, enrollment time, internal and external validity, ability to evaluate interactions among treatments, and cost.

  12. Zinc as an adjunct to antibiotics for the treatment of severe pneumonia in children <5 years: a meta-analysis of randomised-controlled trials.

    Science.gov (United States)

    Tie, Hong-Tao; Tan, Qi; Luo, Ming-Zhu; Li, Qiang; Yu, Jia-Lin; Wu, Qing-Chen

    2016-03-14

    The effect of Zn, as an adjunct to antibiotics, on the treatment of severe pneumonia in young children is still under debate; therefore, we performed a meta-analysis to evaluate the therapeutic role of Zn for severe pneumonia in children younger than 5 years. PubMed, Cochrane library and Embase databases were systematically searched from inception until October 2015 for randomised-controlled trials (RCT) that assessed the effect of Zn as an adjunct to antibiotics for severe pneumonia. Random-effects model was used for calculating the pooled estimates, and intention-to-treat principle was also applied. Nine RCT involving 2926 children were included. Overall, the pooled results showed that adjunct treatment with Zn failed to reduce the time to recovery from severe pneumonia (hazard ratios (HR)=1·04; 95% CI 0·90, 1·19; I(2)=39%; P=0·58), hospital length of stay (HR=1·04; 95% CI 0·83, 1·33; I(2)=57%; P=0·74), treatment failure (relative risk (RR)=0·95; 95% CI 0·79, 1·14; I(2)=20%; P=0·58) or change of antibiotics (RR=1·07; 95% CI 0·79, 1·45; I(2)=44%; P=0·67). In addition, continuous outcomes were consistent while meta-analysed with standard mean difference, and all outcomes remained stable in intention-to-treat analysis. No significant differences were observed in the two groups between death rate, adverse events or recovery times of severe pneumonia indicators. Our results suggested that adjunct treatment with Zn failed to benefit young children in the treatment of severe pneumonia. Considering the clinical heterogeneity, baseline characteristics of children, definition of severe pneumonia and Zn supplement way should be taken into consideration in future research. This study was registered at PRESPERO as CRD42015019798.

  13. 'Be active, eat right', evaluation of an overweight prevention protocol among 5-year-old children: design of a cluster randomised controlled trial

    OpenAIRE

    Veldhuis Lydian; Struijk Mirjam K; Kroeze Willemieke; Oenema Anke; Renders Carry M; Bulk-Bunschoten Anneke MW; HiraSing Remy A; Raat Hein

    2009-01-01

    Abstract Background The prevalence of overweight and obesity in children has at least doubled in the past 25 years with a major impact on health. In 2005 a prevention protocol was developed applicable within Youth Health Care. This study aims to assess the effects of this protocol on prevalence of overweight and health behaviour among children. Methods and design A cluster randomised controlled trial is conducted among 5-year-old children included by 44 Youth Health Care teams randomised with...

  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...

  15. Sentinel node biopsy in head and neck squamous cell cancer: 5-year follow-up of a European multicenter trial

    DEFF Research Database (Denmark)

    Alkureishi, Lee W T; Ross, Gary L; Shoaib, Taimur;

    2010-01-01

    Sentinel node biopsy (SNB) may represent an alternative to elective neck dissection for the staging of patients with early head and neck squamous cell carcinoma (HNSCC). To date, the technique has been successfully described in a number of small single-institution studies. This report describes...... the long-term follow-up of a large European multicenter trial evaluating the accuracy of the technique....

  16. Statistical properties of randomization in clinical trials.

    Science.gov (United States)

    Lachin, J M

    1988-12-01

    This is the first of five articles on the properties of different randomization procedures used in clinical trials. This paper presents definitions and discussions of the statistical properties of randomization procedures as they relate to both the design of a clinical trial and the statistical analysis of trial results. The subsequent papers consider, respectively, the properties of simple (complete), permuted-block (i.e., blocked), and urn (adaptive biased-coin) randomization. The properties described herein are the probabilities of treatment imbalances and the potential effects on the power of statistical tests; the permutational basis for statistical tests; and the potential for experimental biases in the assessment of treatment effects due either to the predictability of the random allocations (selection bias) or the susceptibility of the randomization procedure to covariate imbalances (accidental bias). For most randomization procedures, the probabilities of overall treatment imbalances are readily computed, even when a stratified randomization is used. This is important because treatment imbalance may affect statistical power. It is shown, however, that treatment imbalance must be substantial before power is more than trivially affected. The differences between a population versus a permutation model as a basis for a statistical test are reviewed. It is argued that a population model can only be invoked in clinical trials as an untestable assumption, rather than being formally based on sampling at random from a population. On the other hand, a permutational analysis based on the randomization actually employed requires no assumptions regarding the origin of the samples of patients studied. The large sample permutational distribution of the family of linear rank tests is described as a basis for easily conducting a variety of permutation tests. Subgroup (stratified) analyses, analyses when some data are missing, and regression model analyses are also

  17. INTRAMUSCULAR VERSUS INTRADERMAL HEPATITIS B REVACCINATION IN HEALTHY NON-RESPONDER CHILDREN:A 5-YEAR PROSPECTIVE RANDOMIZED STUDY

    Institute of Scientific and Technical Information of China (English)

    Zhuang Guihua; Yan Hong; Wang Xueliang; Wu Qian; Wang Lirong; Gao Haiyan

    2005-01-01

    Objective With the same times of injection to compare low-dose intradermal regimen with routine-dose intramuscular inoculation in revaccination of non-responders to hepatitis B vaccine. Methods 40 healthy non-responder children collected by screening were administrated a three-dose revaccination randomly by intramuscular or intradermal route (10 vs 2 g per dose), and regularly tested for serologic markers up to five years. By the end of follow-up, a booster dose (5 μg) was given to those who had lost anti-HBs of ≥10 mIU/mL (seroprotection) and anamnestic response was estimated thereafter. Results All 17 intramuscular and 22 of 23 intradermal children effected seroprotection after revaccination. Intradermal children lost seroprotection over time significantly rapider compared with intramuscular children (Log Rank test, P= 0.029). In year 5, 50% of intramuscular but only 18.2% of intradermal children still maintained seroprotection (P=0.075). 12-14 days after the booster dose, all the eight intramuscular children developed an anamnestic response with anti-HBs titer increasing greater, but two of the 18 intradermal children failed to mount seroprotective level. Conclusion Three-routine-dose intramuscular revaccination was significantly effective than low-dose intradermal one with the same times of injection, especially in long-term immunity. We recommend routine-dose intramuscular protocol in revaccination of non-responders.

  18. A randomized lifestyle intervention with 5-year follow-up in subjects with impaired glucose tolerance: pronounced short-term impact but long-term adherence problems

    DEFF Research Database (Denmark)

    Lindahl, Bernt; Nilssön, Torbjörn K; Borch-Johnsen, Knut;

    2009-01-01

    AIMS: To compare data on cardiovascular risk factor changes in lipids, insulin, proinsulin, fibrinolysis, leptin and C-reactive protein, and on diabetes incidence, in relation to changes in lifestyle. METHODS: The study was a randomized lifestyle intervention trial conducted in northern Sweden be...

  19. Covariate-based constrained randomization of group-randomized trials.

    Science.gov (United States)

    Moulton, Lawrence H

    2004-01-01

    Group-randomized study designs are useful when individually randomized designs are either not possible, or will not be able to estimate the parameters of interest. Blocked and/or stratified (for example, pair-matched) designs have been used, and their properties statistically evaluated by many researchers. Group-randomized trials often have small numbers of experimental units, and strong, geographically induced between-unit correlation, which increase the chance of obtaining a "bad" randomization outcome. This article describes a procedure--random selection from a list of acceptable allocations--to allocate treatment conditions in a way that ensures balance on relevant covariates. Numerous individual- and group-level covariates can be balanced using exact or caliper criteria. Simulation results indicate that this method has good frequency properties, but some care may be needed not to overly constrain the randomization. There is a trade-off between achieving good balance through a highly constrained design, and jeopardizing the appearance of impartiality of the investigator and potentially departing from the nominal Type I error. PMID:16279255

  20. Diagnostic randomized controlled trials: the final frontier.

    Science.gov (United States)

    Rodger, Marc; Ramsay, Tim; Fergusson, Dean

    2012-08-16

    Clinicians, patients, governments, third-party payers, and the public take for granted that diagnostic tests are accurate, safe and effective. However, we may be seriously misled if we are relying on robust study design to ensure accurate, safe, and effective diagnostic tests. Properly conducted, randomized controlled trials are the gold standard for assessing the effectiveness and safety of interventions, yet are rarely conducted in the assessment of diagnostic tests. Instead, diagnostic cohort studies are commonly performed to assess the characteristics of a diagnostic test including sensitivity and specificity. While diagnostic cohort studies can inform us about the relative accuracy of an experimental diagnostic intervention compared to a reference standard, they do not inform us about whether the differences in accuracy are clinically important, or the degree of clinical importance (in other words, the impact on patient outcomes). In this commentary we provide the advantages of the diagnostic randomized controlled trial and suggest a greater awareness and uptake in their conduct. Doing so will better ensure that patients are offered diagnostic procedures that will make a clinical difference.

  1. Marital Status and Satisfaction Five Years Following a Randomized Clinical Trial Comparing Traditional versus Integrative Behavioral Couple Therapy

    Science.gov (United States)

    Christensen, Andrew; Atkins, David C.; Baucom, Brian; Yi, Jean

    2010-01-01

    Objective: To follow distressed married couples for 5 years after their participation in a randomized clinical trial. Method: A total of 134 chronically and seriously distressed married couples were randomly assigned to approximately 8 months of either traditional behavioral couple therapy (TBCT; Jacobson & Margolin, 1979) or integrative…

  2. A phase I/II trial of intraoperative breast radiotherapy in an Asian population: 5-year results of local control and cosmetic outcome

    International Nuclear Information System (INIS)

    To date, there are no reports of intraoperative radiotherapy (IORT) use with long-term follow up as a method of accelerated partial breast irradiation (APBI) in Asian countries. We initiated a prospective phase I/II clinical trial of IORT in Japan in 2007, and herein, we report the 5-year follow-up results. The following inclusion criteria were used for enrollment in the trial: (1) tumor size < 2.5 cm, (2) desire for breast-conserving surgery, (3) age >50 years, and (4) negative margins after resection. In February 2009, the eligibility criteria were changed to include only patients with sentinel lymph node-negative disease. In phase I, the radiotherapy dose was escalated from 19 Gy/fr to 21 Gy/fr, incremented by 1 Gy per step, with 3 patients in each step. Doses were escalated after all patients in the preceding cohort had completed treatment and exhibited only grade 1 or 2 toxicities at a given dose level. The recommended phase II dose was set at 21 Gy at 90 % isodose. The primary endpoint was early toxicity. Secondary endpoints were long-term efficacy and late toxicity. In addition, Hypertrophic scarring was evaluated retrospectively as a cosmetic outcome by a radiation oncologist. Between December 2007 and March 2010, 32 women with breast cancer were enrolled in the trial. The median age was 65 years (51–80 years), and the median follow-up time was 6 years. No recurrence or metastasis was observed in any patient. Grade 2 fibrosis was detected in 3 patients as an acute adverse event and in 2 patients as a late adverse event. Ten patients developed a hypertrophic scar 1 year after the IORT; the number of patients decreased to 7 in the 3 years of follow-up. The first group of female Asian patients tolerated the treatment with IORT in this Phase I/II study and remained recurrence-free for more than 5 years after treatment. However, 24 % of the patients developed hypertrophic scarring, an event that is being further examined in our ongoing multi-center Phase II

  3. Long-term safety and performance of the orbital atherectomy system for treating calcified coronary artery lesions: 5-Year follow-up in the ORBIT I trial

    Energy Technology Data Exchange (ETDEWEB)

    Bhatt, Parloop; Parikh, Parth [Care Institute of Medical Sciences (CIMS), Ahmedabad 380060, Gujarat (India); Patel, Apurva [Internal Medicine, Cleveland Clinic Foundation, Cleveland, OH (United States); Chag, Milan; Chandarana, Anish [Care Institute of Medical Sciences (CIMS), Ahmedabad 380060, Gujarat (India); Parikh, Roosha [Internal Medicine, Cleveland Clinic Foundation, Cleveland, OH (United States); Parikh, Keyur, E-mail: keyur.parikh@cims.me [Care Institute of Medical Sciences (CIMS), Ahmedabad 380060, Gujarat (India)

    2015-06-15

    Background/Purpose: The ORBIT I trial, a first-in-man study, was conducted to evaluate the safety and performance of the orbital atherectomy system (OAS) in treating de novo calcified coronary lesions. Methods/Materials: Fifty patients were enrolled between May and July 2008 based on several criteria, and were treated with the OAS followed by stent placement. The safety and performance of the OAS were evaluated by procedural success, device success, and overall major adverse cardiovascular event (MACE) rates, including cardiac death, myocardial infarction (MI) and need for target lesion revascularization (TLR). Our institution enrolled and treated 33 of the 50 patients and continued follow-up for 5 years. Results: Average age was 54 years and 91% were males. Mean lesion length was 15.9 mm. Device success was 100%, and average number of orbital atherectomy devices (OAD) used per patient was 1.3. Stents were placed directly after OAS in 31/32 patients (96.9%). All stents (average stent per lesion 1.1) were successfully deployed with 0.3% residual stenosis. The overall cumulative MACE rate was 6.1% in-hospital, 9.1% at 30 days, 12.1% at 6 months, 15.2% at 2 years, 18.2% at 3 years and 21.2% at 5 years (4 total cardiac deaths). None of the patients had Q-wave MIs. Angiographic complications were observed in 5 patients. No flow/slow flow due to distal embolization was observed. Conclusions: The ORBIT I trial suggests that OAS treatment continues to offer a safe and effective method to change compliance of calcified coronary lesions to facilitate optimal stent placement in these difficult-to-treat patients.

  4. 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 random

  5. 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.

  6. A cluster randomised trial of a telephone-based intervention for parents to increase fruit and vegetable consumption in their 3- to 5-year-old children: study protocol

    Directory of Open Access Journals (Sweden)

    Fletcher Amanda

    2010-04-01

    Full Text Available Abstract Background Inadequate fruit and vegetable consumption in childhood increases the risk of developing chronic disease. Despite this, a substantial proportion of children in developed nations, including Australia, do not consume sufficient quantities of fruits and vegetables. Parents are influential in the development of dietary habits of young children but often lack the necessary knowledge and skills to promote healthy eating in their children. The aim of this study is to assess the efficacy of a telephone-based intervention for parents to increase the fruit and vegetable consumption of their 3- to 5-year-old children. Methods/Design The study, conducted in the Hunter region of New South Wales, Australia, employs a cluster randomised controlled trial design. Two hundred parents from 15 randomly selected preschools will be randomised to receive the intervention, which consists of print resources and four weekly 30-minute telephone support calls delivered by trained telephone interviewers. The calls will assist parents to increase the availability and accessibility of fruit and vegetables in the home, create supportive family eating routines and role-model fruit and vegetable consumption. A further two hundred parents will be randomly allocated to the control group and will receive printed nutrition information only. The primary outcome of the trial will be the change in the child's consumption of fruit and vegetables as measured by the fruit and vegetable subscale of the Children's Dietary Questionnaire. Pre-intervention and post-intervention parent surveys will be administered over the telephone. Baseline surveys will occur one to two weeks prior to intervention delivery, with follow-up data collection calls occurring two, six, 12 and 18 months following baseline data collection. Discussion If effective, this telephone-based intervention may represent a promising public health strategy to increase fruit and vegetable consumption in

  7. Accelerated Partial Breast Irradiation: 5-Year Results of the German-Austrian Multicenter Phase II Trial Using Interstitial Multicatheter Brachytherapy Alone After Breast-Conserving Surgery

    International Nuclear Information System (INIS)

    Purpose: To evaluate the impact of accelerated partial breast irradiation on local control, side effects, and cosmesis using multicatheter interstitial brachytherapy as the sole method for the adjuvant local treatment of patients with low-risk breast cancer. Methods and Materials: 274 patients with low-risk breast cancer were treated on protocol. Patients were eligible for the study if the tumor size was 35 years, hormone receptors were positive, and histologic grades were 1 or 2. Of the 274 patients, 175 (64%) received pulse-dose-rate brachytherapy (Dref = 50 Gy). and 99 (36%) received high-dose-rate brachytherapy (Dref = 32.0 Gy). Results: Median follow-up was 63 months (range, 9-103). Only 8 of 274 (2.9%) patients developed an ipsilateral in-breast tumor recurrence at the time of analysis. The 5-year actuarial local recurrence-free survival probability was 98%. The 5- year overall and disease-free survival probabilities of all patients were 97% and 96%, respectively. Contralateral in-breast malignancies were detected in 2 of 274 (0.7%) patients, and distant metastases occurred in 6 of 274 (2.2%). Late side effects ≥Grade 3 (i.e., breast tissue fibrosis and telangiectasia) occurred in 1 patient (0.4%, 95%CI:0.0-2.0%) and 6 patients (2.2%, 95%CI:0.8-4.7%), respectively. Cosmetic results were good to excellent in 245 of 274 patients (90%). Conclusions: The long-term results of this prospective Phase II trial confirm that the efficacy of accelerated partial breast irradiation using multicatheter brachytherapy is comparable with that of whole breast irradiation and that late side effects are negligible.

  8. Barriers to Clinical Research Participation in a Diabetes Randomized Clinical Trial

    OpenAIRE

    Yozwiak, John A; Bearman, Diane L; Strand, Trudy D.; Strasburg, Katherine R; Robiner, William N

    2009-01-01

    Little is known about how barriers to research participation are perceived, affected by or interact with patient characteristics, or how they vary over the course of a clinical trial. Participants (285) in the Renin-Angiotensin System Study (RASS), a randomized clinical primary prevention study of diabetic nephropathy and retinopathy at 2 Canadiana dn 1 US university, rated potential barriers to research participation yearly for 5 years. Baseline barriers rated as most adversely affecting par...

  9. A Framework for Designing Cluster Randomized Trials with Binary Outcomes

    Science.gov (United States)

    Spybrook, Jessaca; Martinez, Andres

    2011-01-01

    The purpose of this paper is to provide a frame work for approaching a power analysis for a CRT (cluster randomized trial) with a binary outcome. The authors suggest a framework in the context of a simple CRT and then extend it to a blocked design, or a multi-site cluster randomized trial (MSCRT). The framework is based on proportions, an…

  10. 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...

  11. 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...

  12. Challenges of randomized controlled trial design in plastic surgery.

    Science.gov (United States)

    Hassanein, Aladdin H; Herrera, Fernando A; Hassanein, Omar

    2011-01-01

    Randomized controlled trials are the gold standard of evidence-based medicine. In the field of plastic surgery, designing these studies is much more challenging than in pharmaceutical medicine. Randomized trials in plastic surgery encompass several road blocks including problems shared with other surgical trials: equipoise, high cost, placebo issues and learning curves following the establishment of a novel approach. In addition, plastic surgery has more subjective outcomes, thus making study design even more difficult in assessing the end result.

  13. Pelvic Organ Prolapse Repair with and without Concomitant Burch Colposuspension in Incontinent Women: A Randomised Controlled Trial with at Least 5-Year Followup

    Directory of Open Access Journals (Sweden)

    Elisabetta Costantini

    2012-01-01

    Full Text Available The aim of this study was to reevaluate and update the followup of a previously published randomized controlled trial (RCT on the impact of Burch Colposuspension (BC, as an anti-incontinence procedure, in patients with UI and POP, who underwent POP repair. Forty-seven women were randomly assigned to abdominal POP repair and concomitant BC (24 patients; group A or POP repair alone without any anti-incontinence procedure (23 patients; group B. Median followup was 82 months (range 60–107; from over 47 patients, 30 reached 6-year followup. Two patients were lost at followup. In group A, 2 patients showed a stage I rectocele. In group B, 2 patients had a stage I rectocele and 1 a stage II rectocele. In group A, 13/23 (56.5% were still incontinent after surgery compared with 9/22 patients (40.9% in group B (P=0.298. No significant changes were observed between the first and the current followup. The update of long-term followup confirmed that BC did not improve outcome significantly in incontinent women when they undergo POP repair.

  14. Control of soil-transmitted helminthiasis in Yunnan province, People's Republic of China: experiences and lessons from a 5-year multi-intervention trial.

    Science.gov (United States)

    Steinmann, Peter; Yap, Peiling; Utzinger, Jürg; Du, Zun-Wei; Jiang, Jin-Yong; Chen, Ran; Wu, Fang-Wei; Chen, Jia-Xu; Zhou, Hui; Zhou, Xiao-Nong

    2015-01-01

    The current global strategy for the control of soil-transmitted helminthiasis emphasises periodic administration of anthelminthic drugs to at-risk populations. However, this approach fails to address the root social and ecological causes of soil-transmitted helminthiasis. For sustainable control, it has been suggested that improvements in water, sanitation and hygiene behaviour are required. We designed a 5-year multi-intervention trial in Menghai county, Yunnan province, People's Republic of China. Three different interventions were implemented, each covering a village inhabited by 200-350 people. The interventions consisted of (i) initial health education at study inception and systematic treatment of all individuals aged ≥2 years once every year with a single dose of albendazole; (ii) initial health education and bi-annual albendazole administration; and (iii) bi-annual treatment coupled with latrine construction at family level and regular health education. Interventions were rigorously implemented for 3 years, whilst the follow-up, which included annual albendazole distribution, lasted for 2 more years. Before the third round of treatment, the prevalence of Ascaris lumbricoides was reduced by only 2.8% in the annual treatment arm, whilst bi-annual deworming combined with latrine construction and health education resulted in a prevalence reduction of 53.3% (pspp., but none of the interventions significantly reduced the prevalence of Strongyloides stercoralis. Our findings support the notion that in high-endemicity areas, sustainable control of soil-transmitted helminth infections necessitates measures to reduce faecal environmental contamination to complement mass drug administration. However, elimination of soil-transmitted helminthiasis will not be achieved in the short run even with a package of interventions, and probably requires improvements in living conditions, changes in hygiene behaviour and more efficacious anthelminthic drugs and treatment

  15. 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

    BACKGROUND: Clinical trials are commonly done without blinded outcome assessors despite the risk of bias. We wanted to evaluate the effect of nonblinded outcome assessment on estimated effects in randomized clinical trials with outcomes that involved subjective measurement scales. METHODS: We...... 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......%). Heterogeneity was moderate (I(2) = 46%, p = 0.02) and unexplained by metaregression. INTERPRETATION: We provide empirical evidence for observer bias in randomized clinical trials with subjective measurement scale outcomes. A failure to blind assessors of outcomes in such trials results in a high risk...

  16. Random allocation software for parallel group randomized trials

    OpenAIRE

    Saghaei Mahmood

    2004-01-01

    Abstract Background Typically, randomization software should allow users to exert control over the different aspects of randomization including block design, provision of unique identifiers and control over the format and type of program output. While some of these characteristics have been addressed by available software, none of them have all of these capabilities integrated into one package. The main objective of the Random Allocation Software project was to enhance the user's control over...

  17. 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. PMID:25065958

  18. Reported methodologic quality and discrepancies between large and small randomized trials in meta-analyses

    DEFF Research Database (Denmark)

    Kjaergard, L L; Villumsen, J; Gluud, C

    2001-01-01

    To explore whether reported methodologic quality affects estimated intervention effects in randomized trials and contributes to discrepancies between the results of large randomized trials and small randomized trials in meta-analyses....

  19. 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...

  20. Randomized Clinical Trial of Interceptive and Comprehensive Orthodontics

    OpenAIRE

    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.

  1. Cognitive rehabilitation in patients with gliomas : a randomized, controlled trial

    NARCIS (Netherlands)

    Gehring, Karin; Sitskoorn, Margriet M; Gundy, Chad M; Sikkes, Sietske A M; Klein, Martin; Postma, Tjeerd J; van den Bent, Martin J; Beute, Guus N; Enting, Roelien H.; Kappelle, Arnoud C; Boogerd, Willem; Veninga, Theo; Twijnstra, Albert; Boerman, Dolf H; Taphoorn, Martin J B; Aaronson, Neil K

    2009-01-01

    PURPOSE: Patients with gliomas often experience cognitive deficits, including problems with attention and memory. This randomized, controlled trial evaluated the effects of a multifaceted cognitive rehabilitation program (CRP) on cognitive functioning and selected quality-of-life domains in patients

  2. 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

    BACKGROUND: Clinical trials are commonly done without blinded outcome assessors despite the risk of bias. We wanted to evaluate the effect of nonblinded outcome assessment on estimated effects in randomized clinical trials with outcomes that involved subjective measurement scales. METHODS: We...... 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...... investigators agreed on the inclusion of trials and the outcome scale. For each trial, we calculated the difference in effect size (i.e., standardized mean difference between nonblinded and blinded assessments). A difference in effect size of less than 0 suggested that nonblinded assessors generated more...

  3. 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....

  4. 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....

  5. 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 of their ......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...

  6. INvestigational Vertebroplasty Efficacy and Safety Trial (INVEST: a randomized controlled trial of percutaneous vertebroplasty

    Directory of Open Access Journals (Sweden)

    Stout Lydia

    2007-12-01

    Full Text Available Abstract Background The treatment of painful osteoporotic vertebral compression fractures has historically been limited to several weeks of bed rest, anti-inflammatory and analgesic medications, calcitonin injections, or external bracing. Percutaneous vertebroplasty (the injection of bone cement into the fractured vertebral body is a relatively new procedure used to treat these fractures. There is increasing interest to examine the efficacy and safety of percutaneous vertebroplasty and to study the possibility of a placebo effect or whether the pain relief is from local anesthetics placed directly on the bone during the vertebroplasty procedure. Methods/Designs Our goal is to test the hypothesis that patients with painful osteoporotic vertebral compression fractures who undergo vertebroplasty have less disability and pain at 1 month than patients who undergo a control intervention. The control intervention is placement of local anesthesia near the fracture, without placement of cement. One hundred sixty-six patients with painful osteoporotic vertebral compression fractures will be recruited over 5 years from US and foreign sites performing the vertebroplasty procedure. We will exclude patients with malignant tumor deposit (multiple myeloma, tumor mass or tumor extension into the epidural space at the level of the fracture. We will randomly assign participants to receive either vertebroplasty or the control intervention. Subjects will complete a battery of validated, standardized measures of pain, functional disability, and health related quality of life at baseline and at post-randomization time points (days 1, 2, 3, and 14, and months 1, 3, 6, and 12. Both subjects and research interviewers performing the follow-up assessments will be blinded to the randomization assignment. Subjects will have a clinic visit at months 1 and 12. Spine X-rays will be obtained at the end of the study (month 12 to determine subsequent fracture rates. Our co

  7. Mood reactivity rather than cognitive reactivity is predictive of depressive relapse : a randomized study with 5.5-year follow-up

    NARCIS (Netherlands)

    van Rijsbergen, Gerard D; Bockting, Claudi L H; Burger, Huibert; Spinhoven, Philip; Koeter, Maarten W J; Ruhe, Eric; Hollon, Steven D; Schene, Aart H

    2013-01-01

    OBJECTIVE: The current study examined whether cognitive reactivity, cognitive extremity reactivity, and mood reactivity following mood provocation predicted relapse in depression over 5.5 years. Additionally, this study was the 1st to examine whether changes in cognitive reactivity and mood reactivi

  8. Mood Reactivity Rather than Cognitive Reactivity Is Predictive of Depressive Relapse: A Randomized Study with 5.5-Year Follow-Up

    Science.gov (United States)

    van Rijsbergen, Gerard D.; Bockting, Claudi L. H.; Burger, Huibert; Spinhoven, Philip; Koeter, Maarten W. J.; Ruhe, Henricus G.; Hollon, Steven D.; Schene, Aart H.

    2013-01-01

    Objective: The current study examined whether cognitive reactivity, cognitive extremity reactivity, and mood reactivity following mood provocation predicted relapse in depression over 5.5 years. Additionally, this study was the 1st to examine whether changes in cognitive reactivity and mood reactivity following preventive cognitive therapy (PCT)…

  9. The design of the run Clever randomized trial

    DEFF Research Database (Denmark)

    Ramskov, Daniel; Nielsen, Rasmus Oestergaard; Sørensen, Henrik;

    2016-01-01

    and the statistical analysis of the collected data. The aim of the Run Clever trial is to investigate if a focus on running intensity compared with a focus on running volume in a running schedule influences the overall injury risk differently. METHODS/DESIGN: The Run Clever trial is a randomized trial with a 24-week...... follow-up. Healthy recreational runners between 18 and 65 years and with an average of 1-3 running sessions per week the past 6 months are included. Participants are randomized into two intervention groups: Running schedule-I and Schedule-V. Schedule-I emphasizes a progression in running intensity...

  10. Power Calculations for Binary Moderator in Cluster Randomized Trials

    Science.gov (United States)

    Spybrook, Jessaca; Kelcey, Ben

    2014-01-01

    Cluster randomized trials (CRTs), or studies in which intact groups of individuals are randomly assigned to a condition, are becoming more common in the evaluation of educational programs, policies, and practices. The website for the National Center for Education Evaluation and Regional Assistance (NCEE) reveals they have launched over 30…

  11. 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 d

  12. Summer School Effects in a Randomized Field Trial

    Science.gov (United States)

    Zvoch, Keith; Stevens, Joseph J.

    2013-01-01

    This field-based randomized trial examined the effect of assignment to and participation in summer school for two moderately at-risk samples of struggling readers. Application of multiple regression models to difference scores capturing the change in summer reading fluency revealed that kindergarten students randomly assigned to summer school…

  13. Estimating the Causal Effect of Randomization versus Treatment Preference in a Doubly Randomized Preference Trial

    Science.gov (United States)

    Marcus, Sue M.; Stuart, Elizabeth A.; Wang, Pei; Shadish, William R.; Steiner, Peter M.

    2012-01-01

    Although randomized studies have high internal validity, generalizability of the estimated causal effect from randomized clinical trials to real-world clinical or educational practice may be limited. We consider the implication of randomized assignment to treatment, as compared with choice of preferred treatment as it occurs in real-world…

  14. 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......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...

  15. Fundamentals of randomized clinical trials in wound care

    DEFF Research Database (Denmark)

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

    2012-01-01

    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...... 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...... randomization is a necessary feature of a robust comparative study, it is not sufficient to ensure a study at low risk of bias. Randomized clinical trials should also ensure adequate allocation concealment and blinding of outcome assessors, apply intention-to-treat analysis, and use patient-oriented outcomes...

  16. Confirmation of the protective effect of Ascaris lumbricoides on Plasmodium falciparum infection: results of a randomized trial in Madagascar.

    Science.gov (United States)

    Brutus, Laurent; Watier, Laurence; Hanitrasoamampionona, Virginie; Razanatsoarilala, Hélène; Cot, Michel

    2007-12-01

    A controlled randomized trial of anti-helminthic treatment was undertaken in 1996-1997 in a rural area of Madagascar where populations were simultaneously infected with Ascaris lumbricoides, Plasmodium falciparum, and Schistosoma mansoni. Levamisole was administered bimonthly to 107 subjects, whereas 105 were controls. Levamisole was highly effective in reducing Ascaris egg loads in the treated group (P 15 years of age. This study confirms the results of a randomized trial, which showed a negative interaction in those > 5 years of age between Ascaris and malaria parasite density in another Malagasy population, submitted to a higher malaria transmission.

  17. Ultramicronized Palmitoylethanolamide (PEA) in spinal cord injury neuropathic pain: a randomized controlled trial

    DEFF Research Database (Denmark)

    Andresen, Sven Robert; Bing, Jette; Hansen, Rikke Bod Middelhede;

    2015-01-01

    . Methods  A randomized, double-blind, placebo-controlled parallel multicenter study. Study population of at least 66 patients must complete the 12 week trial.Questionnaires regarding neuropathic pain, spasticity, insomnia, anxiety and depression are completed before and after treatment. A numeric...... is 55.3 (±9.5) years and average time since injury is 8.8 (±8.9)years. Causes of injury are 31% transport, 27% fall, 21% non-traumatic SCI, 14% other traumatic cause and 7% sports injuries. No major side effectshave been reported. Further results will be presented at the meeting...

  18. Randomized controlled trial of adjuvant oral dexamethasone pulse therapy in pemphigus vulgaris - PEMPULS trial

    NARCIS (Netherlands)

    Mentink, LF; Mackenzie, MW; Toth, GG; Laseur, M; Lambert, FPG; Veeger, NJGM; Cianchini, G; Pavlovic, MD; Jonkman, MF

    2006-01-01

    Objective: To determine the therapeutic effect of adjuvant dexamethasone pulse therapy when given in addition to conventional treatment of pemphigus vulgaris. Design: A randomized, placebo-controlled trial. Setting: International European, multicenter outpatient and inpatient study. Patients: Of the

  19. Canadian Optically-guided approach for Oral Lesions Surgical (COOLS trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Poh Catherine F

    2011-10-01

    Full Text Available Abstract Background Oral cancer is a major health problem worldwide. The 5-year survival rate ranges from 30-60%, and has remained unchanged in the past few decades. This is mainly due to late diagnosis and high recurrence of the disease. Of the patients who receive treatment, up to one third suffer from a recurrence or a second primary tumor. It is apparent that one major cause of disease recurrence is clinically unrecognized field changes which extend beyond the visible tumor boundary. We have previously developed an approach using fluorescence visualization (FV technology to improve the recognition of the field at risk surrounding a visible oral cancer that needs to be removed and preliminary results have shown a significant reduction in recurrence rates. Method/Design This paper describes the study design of a randomized, multi-centre, double blind, controlled surgical trial, the COOLS trial. Nine institutions across Canada will recruit a total of 400 patients with oral severe dysplasia or carcinoma in situ (N = 160 and invasive squamous cell carcinoma (N = 240. Patients will be stratified by participating institution and histology grade and randomized equally into FV-guided surgery (experimental arm or white light-guided surgery (control arm. The primary endpoint is a composite of recurrence at or 1 cm within the previous surgery site with 1 the same or higher grade histology compared to the initial diagnosis (i.e., the diagnosis used for randomization; or 2 further treatment due to the presence of severe dysplasia or higher degree of change at follow-up. This is the first randomized, multi-centre trial to validate the effectiveness of the FV-guided surgery. Discussion In this paper we described the strategies, novelty, and challenges of this unique trial involving a surgical approach guided by the FV technology. The success of the trial requires training, coordination, and quality assurance across multiple sites within Canada. The COOLS

  20. 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...... providing a classification of clinical trial outcomes and a descriptive study of how outcomes were classified in 200 PubMed indexed clinical trial reports published in 2012. RESULTS: We identified 90 methodological publications with some form of a classification of outcomes. Three distinct definitions were...

  1. A Randomized Trial Comparing Digital and Live Lecture Formats

    OpenAIRE

    Solomon PhD, David J.

    2004-01-01

    Problem Statement and Background – Medical education is increasingly being conducted in community-based teaching sites making it difficult to provide a consistent curriculum. We conducted a randomized trial to assess whether digital lectures could replace live lectures. Methods – Students were randomized to either attending a lecture series at our main campus or viewing digital versions of the same lectures at community sites. Both groups completed an examination based on the lectures and ...

  2. Hypnotherapy in radiotherapy patients: A randomized trial

    International Nuclear Information System (INIS)

    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 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. Results: 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 < 0.05) and overall (p < 0.05) well-being. Conclusion: 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

  3. 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

  4. Randomization Methods in Emergency Setting Trials: A Descriptive Review

    Science.gov (United States)

    Corbett, Mark Stephen; Moe-Byrne, Thirimon; Oddie, Sam; McGuire, William

    2016-01-01

    Background: Quasi-randomization might expedite recruitment into trials in emergency care settings but may also introduce selection bias. Methods: We searched the Cochrane Library and other databases for systematic reviews of interventions in emergency medicine or urgent care settings. We assessed selection bias (baseline imbalances) in prognostic…

  5. Acupuncture as pain relief during delivery: a randomized controlled trial

    DEFF Research Database (Denmark)

    Borup, Lissa; Wurlitzer, Winnie; Hedegaard, Morten;

    2009-01-01

    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. Levetiracetam in spinal cord injury pain: a randomized controlled trial

    DEFF Research Database (Denmark)

    Finnerup, N B; Grydehøj, J; Bing, J;

    2009-01-01

    STUDY DESIGN: A randomized, double-blind, placebo-controlled, crossover, multicenter trial. A 1-week baseline period was followed by two treatment periods of 5 weeks duration with levetiracetam increased from 500 mg b.i.d. to a maximum of 1500 mg b.i.d. separated by a 1-week washout period...

  7. 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.

    2013-01-01

    Objective: 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…

  8. 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 tri

  9. 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...

  10. 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…

  11. Teacher Awareness Program on Child Abuse: A Randomized Controlled Trial.

    Science.gov (United States)

    McGrath, Patrick; And Others

    1987-01-01

    Because teachers lack knowledge of the law, of school board policies, and of issues regarding child abuse and neglect, a professional development workshop was developed and presented to all teachers in the Ottawa Public Schools. Evaluation by a randomized controlled trial showed the workshop effective in increasing and maintaining knowledge.…

  12. The FDA-NIMH-MATRICS Guidelines for Clinical Trial Design of Cognitive-Enhancing Drugs: What Do We Know 5 Years Later?

    OpenAIRE

    Buchanan, Robert W.; Keefe, Richard S. E.; Umbricht, Daniel; Green, Michael F; Laughren, Thomas; Marder, Stephen R.

    2010-01-01

    The Food and Drug Administration (FDA)-National Institute of Mental Health (NIMH)-Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) clinical trial guidelines for cognitive-enhancing drugs in schizophrenia and the MATRICS Consensus Cognitive Battery (MCCB) were designed to facilitate novel compound development in the treatment of cognitive impairments. Several studies have recently utilized the FDA-NIMH-MATRICS guidelines and MCCB and allow an evaluation of the...

  13. Canadian Optically-guided approach for Oral Lesions Surgical (COOLS) trial: study protocol for a randomized controlled trial

    International Nuclear Information System (INIS)

    Oral cancer is a major health problem worldwide. The 5-year survival rate ranges from 30-60%, and has remained unchanged in the past few decades. This is mainly due to late diagnosis and high recurrence of the disease. Of the patients who receive treatment, up to one third suffer from a recurrence or a second primary tumor. It is apparent that one major cause of disease recurrence is clinically unrecognized field changes which extend beyond the visible tumor boundary. We have previously developed an approach using fluorescence visualization (FV) technology to improve the recognition of the field at risk surrounding a visible oral cancer that needs to be removed and preliminary results have shown a significant reduction in recurrence rates. This paper describes the study design of a randomized, multi-centre, double blind, controlled surgical trial, the COOLS trial. Nine institutions across Canada will recruit a total of 400 patients with oral severe dysplasia or carcinoma in situ (N = 160) and invasive squamous cell carcinoma (N = 240). Patients will be stratified by participating institution and histology grade and randomized equally into FV-guided surgery (experimental arm) or white light-guided surgery (control arm). The primary endpoint is a composite of recurrence at or 1 cm within the previous surgery site with 1) the same or higher grade histology compared to the initial diagnosis (i.e., the diagnosis used for randomization); or 2) further treatment due to the presence of severe dysplasia or higher degree of change at follow-up. This is the first randomized, multi-centre trial to validate the effectiveness of the FV-guided surgery. In this paper we described the strategies, novelty, and challenges of this unique trial involving a surgical approach guided by the FV technology. The success of the trial requires training, coordination, and quality assurance across multiple sites within Canada. The COOLS trial, an example of translational research, may result in

  14. Methods for analyzing cost effectiveness data from cluster randomized trials

    Directory of Open Access Journals (Sweden)

    Clark Allan

    2007-09-01

    Full Text Available Abstract Background Measurement of individuals' costs and outcomes in randomized trials allows uncertainty about cost effectiveness to be quantified. Uncertainty is expressed as probabilities that an intervention is cost effective, and confidence intervals of incremental cost effectiveness ratios. Randomizing clusters instead of individuals tends to increase uncertainty but such data are often analysed incorrectly in published studies. Methods We used data from a cluster randomized trial to demonstrate five appropriate analytic methods: 1 joint modeling of costs and effects with two-stage non-parametric bootstrap sampling of clusters then individuals, 2 joint modeling of costs and effects with Bayesian hierarchical models and 3 linear regression of net benefits at different willingness to pay levels using a least squares regression with Huber-White robust adjustment of errors, b a least squares hierarchical model and c a Bayesian hierarchical model. Results All five methods produced similar results, with greater uncertainty than if cluster randomization was not accounted for. Conclusion Cost effectiveness analyses alongside cluster randomized trials need to account for study design. Several theoretically coherent methods can be implemented with common statistical software.

  15. Sequential monitoring of response-adaptive randomized clinical trials

    CERN Document Server

    Zhu, Hongjian; 10.1214/10-AOS796

    2010-01-01

    Clinical trials are complex and usually involve multiple objectives such as controlling type I error rate, increasing power to detect treatment difference, assigning more patients to better treatment, and more. In literature, both response-adaptive randomization (RAR) procedures (by changing randomization procedure sequentially) and sequential monitoring (by changing analysis procedure sequentially) have been proposed to achieve these objectives to some degree. In this paper, we propose to sequentially monitor response-adaptive randomized clinical trial and study it's properties. We prove that the sequential test statistics of the new procedure converge to a Brownian motion in distribution. Further, we show that the sequential test statistics asymptotically satisfy the canonical joint distribution defined in Jennison and Turnbull (\\citeyearJT00). Therefore, type I error and other objectives can be achieved theoretically by selecting appropriate boundaries. These results open a door to sequentially monitor res...

  16. 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.

  17. Tooth-surface-specific Effects of Xylitol: Randomized Trial Results

    OpenAIRE

    Ritter, A.V.; Bader, J.D.; Leo, M. C.; Preisser, J.S.; Shugars, D.A.; Vollmer, W.M.; Amaechi, B.T.; Holland, J.C.

    2013-01-01

    The Xylitol for Adult Caries Trial was a three-year, double-blind, multi-center, randomized clinical trial that evaluated the effectiveness of xylitol vs. placebo lozenges in the prevention of dental caries in caries-active adults. The purpose of this secondary analysis was to investigate whether xylitol lozenges had a differential effect on cumulative caries increments on different tooth surfaces. Participants (ages 21-80 yrs) with at least one follow-up visit (n = 620) were examined at base...

  18. Preference in random assignment: implications for the interpretation of randomized trials.

    Science.gov (United States)

    Macias, Cathaleene; Gold, Paul B; Hargreaves, William A; Aronson, Elliot; Bickman, Leonard; Barreira, Paul J; Jones, Danson R; Rodican, Charles F; Fisher, William H

    2009-09-01

    Random assignment to a preferred experimental condition can increase service engagement and enhance outcomes, while assignment to a less-preferred condition can discourage service receipt and limit outcome attainment. We examined randomized trials for one prominent psychiatric rehabilitation intervention, supported employment, to gauge how often assignment preference might have complicated the interpretation of findings. Condition descriptions, and greater early attrition from services-as-usual comparison conditions, suggest that many study enrollees favored assignment to new rapid-job-placement supported employment, but no study took this possibility into account. Reviews of trials in other service fields are needed to determine whether this design problem is widespread.

  19. Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available.

    Science.gov (United States)

    Hernán, Miguel A; Robins, James M

    2016-04-15

    Ideally, questions about comparative effectiveness or safety would be answered using an appropriately designed and conducted randomized experiment. When we cannot conduct a randomized experiment, we analyze observational data. Causal inference from large observational databases (big data) can be viewed as an attempt to emulate a randomized experiment-the target experiment or target trial-that would answer the question of interest. When the goal is to guide decisions among several strategies, causal analyses of observational data need to be evaluated with respect to how well they emulate a particular target trial. We outline a framework for comparative effectiveness research using big data that makes the target trial explicit. This framework channels counterfactual theory for comparing the effects of sustained treatment strategies, organizes analytic approaches, provides a structured process for the criticism of observational studies, and helps avoid common methodologic pitfalls. PMID:26994063

  20. 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

    2013-01-01

    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. PMID:23816507

  1. 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......)) and blood biomarkers of brain injury (S100β, brain fatty acid-binding protein, and neuroketal). METHODS: One hundred and sixty-six extremely preterm infants were randomized to either experimental or control group. EEG was recorded at 64 h of age and blood samples were collected at 6 and 64 h of age. RESULTS...

  2. Effect of Playful Balancing Training - A Pilot Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Lund, Henrik Hautop; Jessen, Jari Due

    2013-01-01

    , agility, endurance, and sensor-motoric reaction. A population of 12 elderly (average age: 79) with balancing problems (DGI average score: 18.7) was randomly assigned to control group or tiles training group, and tested before and after intervention. The tiles training group had statistical significant...... increase in balancing performance (DGI score: 21.3) after short-term playful training with the modular interactive tiles, whereas the control group remained with a score indicating balancing problems and risk of falling (DGI score: 16.6). The small pilot randomized controlled trial suggests...

  3. Randomization as a basis for inference in noninferiority trials.

    Science.gov (United States)

    Wiens, Brian L

    2006-01-01

    Noninferiority testing in clinical trials is commonly understood in a Neyman-Pearson framework, and has been discussed in a Bayesian framework as well. In this paper, we discuss noninferiority testing in a Fisherian framework, in which the only assumption necessary for inference is the assumption of randomization of treatments to study subjects. Randomization plays an important role in not only the design but also the analysis of clinical trials, no matter the underlying inferential field. The ability to utilize permutation tests depends on assumptions around exchangeability, and we discuss the possible uses of permutation tests in active control noninferiority analyses. The other practical implications of this paper are admittedly minor but lead to better understanding of the historical and philosophical development of active control noninferiority testing. The conclusion may also frame discussion of other complicated issues in noninferiority testing, such as the role of an intention to treat analysis.

  4. Neoadjuvant Chemoradiation for Distal Rectal Cancer: 5-Year Updated Results of a Randomized Phase 2 Study of Neoadjuvant Combined Modality Chemoradiation for Distal Rectal Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Mohiuddin, Mohammed, E-mail: asemuddin@gmail.com [King Faisal Specialist Hospital and Research Centre, Riyadh (Saudi Arabia); Paulus, Rebecca [RTOG Statistical Department, Philadelphia, Pennsylvania (United States); Mitchell, Edith [Thomas Jefferson University, Philadelphia, Pennsylvania (United States); Hanna, Nader [Department of Surgical Oncology, University of Maryland Medical Center, Baltimore, Maryland (United States); Yuen, Albert [Reading Hospital and Medical Center, Reading, Pennsylvania (United States); Nichols, Romaine [University of Florida Proton Therapy Institute, Jacksonville, Florida (United States); Yalavarthi, Salochna [Ingalls Memorial Hospital, Harvey, Illinois (United States); Hayostek, Cherie [Santa Fe Cancer Center, Santa Fe, New Mexico (United States); Willett, Christopher [Duke University Medical Center, Durham, North Carolina (United States)

    2013-07-01

    Purpose: To assess the efficacy of 2 different approaches to neoadjuvant chemoradiation for distal rectal cancers. Methods and Materials: One hundred six patients with T3/T4 distal rectal cancers were randomized in a phase 2 study. Patients received either continuous venous infusion (CVI) of 5-Fluorouracil (5-FU), 225 mg/m{sup 2} per day, 7 days per week plus pelvic hyperfractionated radiation (HRT), 45.6 Gy at 1.2 Gy twice daily plus a boost of 9.6 to 14.4 Gy for T3 or T4 cancers (Arm 1), or CVI of 5-FU, 225 mg/m{sup 2} per day, Monday to Friday, plus irinotecan, 50 mg/m{sup 2} once weekly × 4, plus pelvic radiation therapy (RT), 45 Gy at 1.8 Gy per day and a boost of 5.4 Gy for T3 and 9 Gy for T4 cancers (Arm 2). Surgery was performed 4 to 10 weeks later. Results: All eligible patients (n=103) are included in this analysis; 2 ineligible patients were excluded, and 1 patient withdrew consent. Ninety-eight of 103 patients (95%) underwent resection. Four patients did not undergo surgery for either disease progression or patient refusal, and 1 patient died during induction chemotherapy. The median time of follow-up was 6.4 years in Arm 1 and 7.0 years in Arm 2. The pathological complete response (pCR) rates were 30% in Arm 1 and 26% in Arm 2. Locoregional recurrence rates were 16% in Arm 1 and 17% in Arm 2. Five-year survival rates were 61% and 75% and Disease-specific survival rates were 78% and 85% for Arm1 and Arm 2, respectively. Five second primaries occurred in patients on Arm 1, and 1 second primary occurred in Arm 2. Conclusions: High rates of disease-specific survival were seen in each arm. Overall survival appears affected by the development of unrelated second cancers. The high pCR rates with 5-FU and higher dose radiation in T4 cancers provide opportunity for increased R0 resections and improved survival.

  5. Project Energize: whole-region primary school nutrition and physical activity programme; evaluation of body size and fitness 5 years after the randomised controlled trial.

    Science.gov (United States)

    Rush, Elaine; McLennan, Stephanie; Obolonkin, Victor; Vandal, Alain C; Hamlin, Michael; Simmons, David; Graham, David

    2014-01-28

    Project Energize, a region-wide whole-school nutrition and physical activity programme, commenced as a randomised controlled trial (RCT) in the period 2004-6 in 124 schools in Waikato, New Zealand. In 2007, sixty-two control schools were engaged in the programme, and by 2011, all but two of the 235 schools in the region were engaged. Energizers (trained nutrition and physical activity specialists) work with eight to twelve schools each to achieve the goals of the programme, which are based on healthier eating and enhanced physical activity. In 2011, indices of obesity and physical fitness of 2474 younger (7·58 (sd 0·57) years) and 2330 older (10·30 (sd 0·51) years) children attending 193 of the 235 primary schools were compared with historical measurements. After adjusting for age, sex, ethnicity, socio-economic status (SES) and school cluster effects, the combined prevalence of obesity and overweight among younger and older children in 2011 was lower by 31 and 15 %, respectively, than that among 'unEnergized' children in the 2004 to 2006 RCT. Similarly, BMI was lower by 3·0 % (95 % CI - 5·8, - 1·3) and 2·4 % (95 % CI - 4·3, - 0·5). Physical fitness (time taken to complete a 550 m run) was significantly higher in the Energized children (13·7 and 11·3 %, respectively) than in a group of similarly aged children from another region. These effects were observed for boys and girls, both indigenous Māori and non-Māori children, and across SES. The long-term regional commitment to the Energize programme in schools may potentially lead to a secular reduction in the prevalence of overweight and obesity and gains in physical fitness, which may reduce the risk of developing obesity and type 2 diabetes. PMID:23867069

  6. Participant informed consent in cluster randomized trials: review.

    Directory of Open Access Journals (Sweden)

    Bruno Giraudeau

    Full Text Available BACKGROUND: The Nuremberg code defines the general ethical framework of medical research with participant consent as its cornerstone. In cluster randomized trials (CRT, obtaining participant informed consent raises logistic and methodologic concerns. First, with randomization of large clusters such as geographical areas, obtaining individual informed consent may be impossible. Second, participants in randomized clusters cannot avoid certain interventions, which implies that participant informed consent refers only to data collection, not administration of an intervention. Third, complete participant information may be a source of selection bias, which then raises methodological concerns. We assessed whether participant informed consent was required in such trials, which type of consent was required, and whether the trial was at risk of selection bias because of the very nature of participant information. METHODS AND FINDINGS: We systematically reviewed all reports of CRT published in MEDLINE in 2008 and surveyed corresponding authors regarding the nature of the informed consent and the process of participant inclusion. We identified 173 reports and obtained an answer from 113 authors (65.3%. In total, 23.7% of the reports lacked information on ethics committee approval or participant consent, 53.1% of authors declared that participant consent was for data collection only and 58.5% that the group allocation was not specified for participants. The process of recruitment (chronology of participant recruitment with regard to cluster randomization was rarely reported, and we estimated that only 56.6% of the trials were free of potential selection bias. CONCLUSIONS: For CRTs, the reporting of ethics committee approval and participant informed consent is less than optimal. Reports should describe whether participants consented for administration of an intervention and/or data collection. Finally, the process of participant recruitment should be fully

  7. Shallow Semantic Parsing of Randomized Controlled Trial Reports

    OpenAIRE

    Paek, Hyung; Kogan, Yacov; Thomas, Prem; Codish, Seymour; Krauthammer, Michael

    2006-01-01

    In this work, we are measuring the performance of Propbank-based Machine Learning (ML) for automatically annotating abstracts of Randomized Controlled Trials (RCTs) with semantically meaningful tags. Propbank is a resource of annotated sentences from the Wall Street Journal (WSJ) corpus, and we were interested in assessing performance issues when porting this resource to the medical domain. We compare intra-domain (WSJ/WSJ) with cross-domain (WSJ/medical abstracts) performance. Although the i...

  8. 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.

  9. A Randomized Controlled Trial of Internet-Delivered Cognitive Behavior Therapy and Acceptance and Commitment Therapy in the Treatment of Tinnitus

    Science.gov (United States)

    Hesser, Hugo; Gustafsson, Tore; Lunden, Charlotte; Henrikson, Oskar; Fattahi, Kidjan; Johnsson, Erik; Westin, Vendela Zetterqvist; Carlbring, Per; Maki-Torkko, Elina; Kaldo, Viktor; Andersson, Gerhard

    2012-01-01

    Objective: Our aim in this randomized controlled trial was to investigate the effects on global tinnitus severity of 2 Internet-delivered psychological treatments, acceptance and commitment therapy (ACT) and cognitive behavior therapy (CBT), in guided self-help format. Method: Ninety-nine participants (mean age = 48.5 years; 43% female) who were…

  10. Differential Susceptibility to Early Literacy Intervention in Children with Mild Perinatal Adversities: Short- and Long-Term Effects of a Randomized Control Trial

    Science.gov (United States)

    Van der Kooy-Hofland, Verna A. C.; Van der Kooy, Jacoba; Bus, Adriana G.; van IJzendoorn, Marinus H.; Bonsel, Gouke J.

    2012-01-01

    In a randomized control trial, the authors tested whether short- and long-term effects of an early literacy intervention are moderated by mild perinatal adversities in accordance with differential susceptibility theory. One-hundred 5-year-old children (58% male) who scored at or below the 30th percentile on early literacy measures were randomized…

  11. Effectiveness of an intervention to reduce sickness absence in patients with emotional distress or minor mental disorders: a randomized controlled effectiveness trial.

    NARCIS (Netherlands)

    Brouwers, E.P.M.; Tiemens, B.G.; Terluin, B.; Verhaak, P.F.M.

    2006-01-01

    OBJECTIVE: The purpose of this study was to evaluate the effectiveness of an activating intervention designed to reduce sick leave duration in patients with emotional distress or minor mental disorders. METHOD: In a 1.5-year randomized controlled trial, 194 patients with minor mental disorders recei

  12. African HIV/AIDS trials are more likely to report adequate allocation concealment and random generation than North American trials.

    OpenAIRE

    Nandi Siegfried; Michael Clarke; Jimmy Volmink; Lize Van der Merwe

    2008-01-01

    BACKGROUND: Adherence to good methodological quality is necessary to minimise bias in randomised conrolled trials (RCTs). Specific trial characteristics are associated with better trial quality, but no studies to date are specific to HIV/AIDS or African trials. We postulated that location may negatively impact on trial quality in regions where resources are scarce. METHODS: 1) To compare the methodological quality of all HIV/AIDS RCTs conducted in Africa with a random sample of similar trials...

  13. Desmopressin versus Oxybutynin for Nocturnal Enuresis in Children in Bandar Abbas: A Randomized Clinical Trial

    Science.gov (United States)

    Ghasemi, Kambiz; Esteghamati, Maryam; Mohammadzadeh, Malihe; Zare, Shahram

    2016-01-01

    Background Nocturnal enuresis is among the most common disorders in children. Several pharmacological and non-pharmacological treatments are available for nocturnal enuresis. Studies for reaching the best pharmacological treatment for this disorder are continuing. Objective To compare the effectiveness and safety of Desmopressin and oxybutynin for treatment of nocturnal enuresis in children from Bandar Abbas in 2014. Methods This randomized controlled trial was conducted in 2014 and participants included 66 children with nocturnal enuresis who were more than 5 years old. Patients were randomly assigned into two groups. The first group received 120 microgram Desmopressin daily for 2 months, then 60 microgram daily for 2 months, then 60 microgram every 2 days. The second group received 5 mg oxybutynin twice a day for 6 months. The patients were followed after 1, 3, and 6 months to track treatment response. The study outcomes were frequency of nocturnal enuresis, urinary incontinency, urgency, and frequency. Data were analyzed using SPSS software. Results There were no significant differences between the two groups with respects to sex, age, place of residence, and parents’ education (pxerostomia were more frequent among the oxybutynin group after 1, 3, and 6 months (p<0.01). Blurred vision was also more frequent among oxybutynin group after 3 months (p<0.01). After 6 months the frequency of nocturnal enuresis and its frequency was higher in oxybutynin group in comparison to the Desmopressin group (p<0.05). Conclusion Desmopressin is more effective and has lower rate of side effects in comparison to oxybutynin for treatment of nocturnal enuresis. We recommend using Desmopressin for treatment of nocturnal enuresis in children. More studies are needed to achieve the best pharmacological treatment option for treatment of nocturnal enuresis. Trial registration The trial is registered at ClinicalTrials.gov with a ClinicalTrials.gov Identifier: NCT02538302 Funding The

  14. The GYMSSA trial: a prospective randomized trial comparing gastrectomy, metastasectomy plus systemic therapy versus systemic therapy alone

    Directory of Open Access Journals (Sweden)

    Berger Ann

    2009-12-01

    Full Text Available Abstract Background The standard of care for metastatic gastric cancer (MGC is systemic chemotherapy which leads to a median survival of 6-15 months. Survival beyond 3 years is rare. For selected groups of patients with limited MGC, retrospective studies have shown improved overall survival following gastrectomy and metastasectomies including peritoneal stripping with continuous hyperthermic peritoneal perfusion (CHPP, liver resection, and pulmonary resection. Median survival after liver resection for MGC is up to 34 months, with a five year survival rate of 24.5%. Similarly, reported median survival after pulmonary resection of MGC is 21 months with long term survival of greater than 5 years a possibility. Several case reports and small studies have documented evidence of long-term survival in select individuals who undergo CHPP for MGC. Design The GYMSSA trial is a prospective randomized trial for patients with MGC. It is designed to compare two therapeutic approaches: gastrectomy with metastasectomy plus systemic chemotherapy (GYMS versus systemic chemotherapy alone (SA. Systemic therapy will be composed of the FOLFOXIRI regimen. The aim of the study is to evaluate overall survival and potential selection criteria to determine those patients who may benefit from surgery plus systemic therapy. The study will be conducted by the Surgery Branch at the National Cancer Institute (NCI, National Institutes of Health (NIH in Bethesda, Maryland. Surgeries and followup will be done at the NCI, and chemotherapy will be given by either the local oncologist or the medical oncology branch at NCI. Trial Registration ClinicalTrials.gov ID. NCT00941655

  15. 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.

  16. Standards of Reporting of Randomized Controlled Trials in General Surgery

    Science.gov (United States)

    Balasubramanian, Sabapathy P.; Wiener, Martin; Alshameeri, Zeiad; Tiruvoipati, Ravindranath; Elbourne, Diana; Reed, Malcolm W.

    2006-01-01

    Objective: To evaluate the quality of reporting of surgical randomized controlled trials published in surgical and general medical journals using Jadad score, allocation concealment, and adherence to CONSORT guidelines and to identify factors associated with good quality. Summary Background Data: Randomized controlled trials (RCTs) provide the best evidence about the relative effectiveness of different interventions. Improper methodology and reporting of RCTs can lead to erroneous conclusions about treatment effects, which may mislead decision-making in health care at all levels. Methods: Information was obtained on RCTs published in 6 general surgical and 4 general medical journals in the year 2003. The quality of reporting of RCTs was assessed under masked conditions using allocation concealment, Jadad score, and a CONSORT checklist devised for the purpose. Results: Of the 69 RCTs analyzed, only 37.7% had a Jadad score of ≥3, and only 13% of the trials clearly explained allocation concealment. The modified CONSORT score of surgical trials reported in medical journals was significantly higher than those reported in surgical journals (Mann-Whitney U test, P < 0.001). Overall, the modified CONSORT score was higher in studies with higher author numbers (P = 0.03), multicenter studies (P = 0.002), and studies with a declared funding source (P = 0.022). Conclusion: The overall quality of reporting of surgical RCTs was suboptimal. There is a need for improving awareness of the CONSORT statement among authors, reviewers, and editors of surgical journals and better quality control measures for trial reporting and methodology. PMID:17060756

  17. Postoperative radiotherapy after radical prostatectomy: a randomized controlled trial (E.O.R.T.C. trial 22911)

    Energy Technology Data Exchange (ETDEWEB)

    Bolla, M. [Centre Hospitalier Universitaire A Michallon, Dept. of Radiation Oncology, 38 - Grenoble (France); Van Poppel, H. [Universitair Ziekenhuis Gasthuisberg, Dept. of Urology, Leuven (Belgium); Collette, L.; Haustermans, K. [Universitair Ziekenhuis Gasthuisberg, Dept. of Radiation Oncology, Leuven (Belgium); Collette, L. [European Organisation for Research and Treatment of Cancer (EORTC) data Center, Brussels (Belgium); Van Cangh, P. [Hopital Saint Luc, Dept. of Urology, Brussels (Belgium); Vekemans, K. [Virga Jesse Ziekenhuis, Dept. of Urology, Hasselt (Belgium); Da Pozzo, L. [Ospedale San Rafaele, Dept. of Urology, Milano (Italy); Reijke, T.M. de [Academisch Medisch Centrum, Dept. of Urology, Amsterdam (Netherlands); Verbaeys, A. [University Hospital, Dept. of Urology, Gent (Belgium); Bosset, J.F. [Hopital Jean Minjoz, Dept. of Radiation Oncology, 25 - Besancon (France); Van Velthoven, R. [Institut Jules Bordet, Dept. Urology, Brussels (Belgium); Marechal, J.M. [Hopital Edouard Herriot, Dept. of Urology, 69 - Lyon (France)

    2008-01-15

    Background - Local failure after prostatectomy can arise in patients with cancer extending beyond the capsule. We did a randomized controlled trial to compare radical prostatectomy followed by immediate external irradiation with prostatectomy alone for patients with positive surgical margin or pT3 prostate cancer. Methods - After undergoing radical retro-pubic prostatectomy, 503 patients were randomly assigned to a wait-and-see policy, and 502 to immediate postoperative radiotherapy (60 Gy conventional irradiation delivered over 6 weeks). Eligible patients had pNOMO tumours and one or more pathological risk factors: capsule perforation, positive surgical margins, invasion of seminal vesicles. Our revised primary endpoint was biochemical progression-free survival. Analysis was by intention to treat. bindings - The median age was 65 years (1QR 61-69). After a median follow-up of 5 years, biochemical progression-free survival was significantly improved in the irradiated group (74.0%, 98% CI 68.7-79.3 vs 52.6%, 46.6-58.5: p0.0001). Clinical progression-free survival was also significantly improved (p=0.0009). The cumulative rate of locoregional failure was significantly lower in the irradiated group (p<0.0001). Grade 2 or 3 late effects were significantly more frequent in the postoperative irradiation group (p=0.0005), but severe toxic toxicity (grade 3 or higher) were rare, with a 5-year rate of 2.6% in the wait-and-see group and 4.2% in the postoperative irradiation group (p=00726). Interpretation: Immediate external irradiation after radical prostatectomy improves biochemical progression-free survival and local control in patients with positive surgical margins or pT3 prostate cancer who are at high risk of progression. Further follow-up is needed to assess the effect on overall survival. (authors)

  18. 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

  19. Power Calculations for Moderators in Multi-Site Cluster Randomized Trials

    Science.gov (United States)

    Spybrook, Jessaca; Kelcey, Ben; Dong, Nianbo

    2016-01-01

    Cluster randomized trials (CRTs), or studies in which intact groups of individuals are randomly assigned to a condition, are becoming more common in evaluation studies of educational programs. A specific type of CRT in which clusters are randomly assigned to treatment within blocks or sites, known as multisite cluster randomized trials (MSCRTs),…

  20. Randomized, Controlled Trial of a Comprehensive Program for Young Students with Autism Spectrum Disorder.

    Science.gov (United States)

    Young, Helen E; Falco, Ruth A; Hanita, Makoto

    2016-02-01

    This randomized, controlled trial, comparing the Comprehensive Autism Program (CAP) and business as usual programs, studied outcomes for 3-5 year old students with autism spectrum disorder (ASD). Participants included 84 teachers and 302 students with ASD and their parents. CAP utilized specialized curricula and training components to implement specific evidence-based practices both at school and home. A comprehensive set of outcome areas was studied. Hierarchical linear modeling was used to estimate the treatment impact. CAP had small positive impacts on the students' receptive language (effect size of .13) and on their social skills as rated by teachers (effect size of .19). Treatment effects were moderated by severity of ASD. PMID:26438637

  1. 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 an...

  2. Making birthing safe for Pakistan women: a cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Khan Muhammad

    2012-07-01

    Full Text Available Abstract Background Two out of three neonatal deaths occur in just 10 countries and Pakistan stands third among them. Maternal mortality is also high with most deaths occurring during labor, birth, and first few hours after birth. Enhanced access and utilization of skilled delivery and emergency obstetric care is the demonstrated strategy in reducing maternal and neonatal mortality. This trial aims to compare reduction in neonate mortality and utilization of available safe birthing and Emergency Obstetric and Neonatal Care services among pregnant mothers receiving ‘structured birth planning’, and/or ‘transport facilitation’ compared to routine care. Methods A pragmatic cluster randomized trial, with qualitative and economic studies, will be conducted in Jhang, Chiniot and Khanewal districts of Punjab, Pakistan, from February 2011 to May 2013. At least 29,295 pregnancies will be registered in the three arms, seven clusters per arm; 1 structured birth planning and travel facilitation, 2 structured birth planning, and 3 control arm. Trial will be conducted through the Lady Health Worker program. Main outcomes are difference in neonatal mortality and service utilization; maternal mortality being the secondary outcome. Cluster level analysis will be done according to intention-to-treat. Discussion A nationwide network of about 100,000 lady health workers is already involved in antenatal and postnatal care of pregnant women. They also act as “gatekeepers” for the child birthing services. This gate keeping role mainly includes counseling and referral for skill birth attendance and travel arrangements for emergency obstetric care (if required. The review of current arrangements and practices show that the care delivery process needs enhancement to include adequate information provision as well as informed “decision” making and planned “action” by the pregnant women. The proposed three-year research is to develop, through national

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

    OpenAIRE

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

    2013-01-01

    Background 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 c...

  4. Mini vs. Standard Implants for Mandibular Overdentures: A Randomized Trial.

    Science.gov (United States)

    de Souza, R F; Ribeiro, A B; Della Vecchia, M P; Costa, L; Cunha, T R; Reis, A C; Albuquerque, R F

    2015-10-01

    A mandibular implant-retained overdenture is considered a first-choice treatment for edentulism. However, some aspects limit the use of standard implants-for example, the width of edentulous ridges, chronic diseases, fear, or costs. This randomized trial compared mandibular overdentures retained by 2 or 4 mini-implants with standard implants, considering oral health-related quality of life (OHRQoL), patient satisfaction, and complications such as lost implant. In sum, 120 edentulous men and women (mean age, 59.5 ± 8.5 y) randomly received 4 mini-implants, 2 mini-implants, or 2 standard implants. Participants provided data regarding OHRQoL and satisfaction until 12 mo. Clinical parameters, including implant survival rate, were also recorded. Both 2 and 4 mini-implants led to better OHRQoL, compared with 2 standard implants. Treatment with 4 mini-implants was more satisfying than 2 standard implants, with 2 mini-implants presenting intermediate results. Implant survival rate was 89%, 82%, and 99% for 4 mini-implants, 2 mini-implants, or 2 standard implants, respectively. Overdentures retained by 4 or 2 mini-implants can achieve OHRQoL and satisfaction at least comparable with that of 2 standard implants. However, the survival rate of mini implants is not as high as that of standard implants (ClinicalTrials.gov NCT01411683). PMID:26294416

  5. Imputation strategies for missing binary outcomes in cluster randomized trials

    Directory of Open Access Journals (Sweden)

    Akhtar-Danesh Noori

    2011-02-01

    Full Text Available Abstract Background Attrition, which leads to missing data, is a common problem in cluster randomized trials (CRTs, where groups of patients rather than individuals are randomized. Standard multiple imputation (MI strategies may not be appropriate to impute missing data from CRTs since they assume independent data. In this paper, under the assumption of missing completely at random and covariate dependent missing, we compared six MI strategies which account for the intra-cluster correlation for missing binary outcomes in CRTs with the standard imputation strategies and complete case analysis approach using a simulation study. Method We considered three within-cluster and three across-cluster MI strategies for missing binary outcomes in CRTs. The three within-cluster MI strategies are logistic regression method, propensity score method, and Markov chain Monte Carlo (MCMC method, which apply standard MI strategies within each cluster. The three across-cluster MI strategies are propensity score method, random-effects (RE logistic regression approach, and logistic regression with cluster as a fixed effect. Based on the community hypertension assessment trial (CHAT which has complete data, we designed a simulation study to investigate the performance of above MI strategies. Results The estimated treatment effect and its 95% confidence interval (CI from generalized estimating equations (GEE model based on the CHAT complete dataset are 1.14 (0.76 1.70. When 30% of binary outcome are missing completely at random, a simulation study shows that the estimated treatment effects and the corresponding 95% CIs from GEE model are 1.15 (0.76 1.75 if complete case analysis is used, 1.12 (0.72 1.73 if within-cluster MCMC method is used, 1.21 (0.80 1.81 if across-cluster RE logistic regression is used, and 1.16 (0.82 1.64 if standard logistic regression which does not account for clustering is used. Conclusion When the percentage of missing data is low or intra

  6. 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.

  7. 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

  8. 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

  9. Stopping randomized trials early for benefit: a protocol of the Study Of Trial Policy Of Interim Truncation-2 (STOPIT-2)

    OpenAIRE

    Mullan Rebecca J; Bankhead Clare R; Kaur Jagdeep; Sood Amit; Raatz Heike; Mulla Sohail M; Burns Karen EA; Nordmann Alain J; Lampropulos Julianna F; Bucher Heiner C; Karanicolas Paul J; You John J; Elnour Nisrin; Soares Heloisa P; Kirpalani Haresh

    2009-01-01

    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 epidemiol...

  10. 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

  11. 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

  12. Robustness of ordinary least squares in randomized clinical trials.

    Science.gov (United States)

    Judkins, David R; Porter, Kristin E

    2016-05-20

    There has been a series of occasional papers in this journal about semiparametric methods for robust covariate control in the analysis of clinical trials. These methods are fairly easy to apply on currently available computers, but standard software packages do not yet support these methods with easy option selections. Moreover, these methods can be difficult to explain to practitioners who have only a basic statistical education. There is also a somewhat neglected history demonstrating that ordinary least squares (OLS) is very robust to the types of outcome distribution features that have motivated the newer methods for robust covariate control. We review these two strands of literature and report on some new simulations that demonstrate the robustness of OLS to more extreme normality violations than previously explored. The new simulations involve two strongly leptokurtic outcomes: near-zero binary outcomes and zero-inflated gamma outcomes. Potential examples of such outcomes include, respectively, 5-year survival rates for stage IV cancer and healthcare claim amounts for rare conditions. We find that traditional OLS methods work very well down to very small sample sizes for such outcomes. Under some circumstances, OLS with robust standard errors work well with even smaller sample sizes. Given this literature review and our new simulations, we think that most researchers may comfortably continue using standard OLS software, preferably with the robust standard errors. Copyright © 2015 John Wiley & Sons, Ltd. PMID:26694758

  13. Competing events and costs of clinical trials: Analysis of a randomized trial in prostate cancer

    International Nuclear Information System (INIS)

    Background: Clinical trial costs may be reduced by identifying enriched subpopulations of patients with favorable risk profiles for the events of interest. However, increased selectivity affects accrual rates, with uncertain impact on clinical trial cost. Methods: We conducted a secondary analysis of Southwest Oncology Group (SWOG) 8794 randomized trial of adjuvant radiotherapy for high-risk prostate cancer. The primary endpoint was metastasis-free survival (MFS), defined as time to metastasis or death from any cause (competing mortality). We used competing risks regression models to identify an enriched subgroup at high risk for metastasis and low risk for competing mortality. We applied a cost model to estimate the impact of enrichment on trial cost and duration. Results: The treatment effect on metastasis was similar in the enriched subgroup (HR, 0.42; 95% CI, 0.23–0.76) compared to the whole cohort (HR, 0.50; 95% CI, 0.30–0.81) while the effect on competing mortality was not significant in the subgroup or the whole cohort (HR 0.70; 95% CI 0.39–1.23, vs. HR 0.94; 95% CI, 0.68–1.31). Due to the higher incidence of metastasis relative to competing mortality in the enriched subgroup, the treatment effect on MFS was greater in the subgroup compared to the whole cohort (HR 0.55; 95% CI 0.36–0.82, vs. HR 0.77; 95% CI, 0.58–1.01). Trial cost was 75% less in the subgroup compared to the whole cohort ($1.7 million vs. $6.8 million), and the trial duration was 30% shorter (8.4 vs. 12.0 years). Conclusion: Competing event enrichment can reduce clinical trial cost and duration, without sacrificing generalizability

  14. 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

  15. 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

  16. Supplemental vibrational force during orthodontic alignment: a randomized trial.

    Science.gov (United States)

    Woodhouse, N R; DiBiase, A T; Johnson, N; Slipper, C; Grant, J; Alsaleh, M; Donaldson, A N A; Cobourne, M T

    2015-05-01

    This prospective 3-arm parallel-group randomized clinical trial investigated the effect of supplemental vibrational force on rate of orthodontic tooth alignment with fixed appliances. Eighty-one subjects (40 males, 41 females; mean age, 14.1 y) undergoing first premolar extraction-based fixed appliance treatment were randomly allocated to treatment supplemented with daily use (20 min) of a removable intraoral vibrational device (AcceleDent; OrthoAccel Technologies Inc.; n = 29), an identical nonfunctional (sham) device (n = 25), or fixed appliances only (n = 27). Mandibular study casts were taken at baseline (treatment start: placement of 0.014-in. nickel-titanium arch wire), initial alignment (0.018-in. nickel-titanium arch wire), and final alignment (0.019 x 0.025-in. stainless steel arch wire). Overall mean irregularity index in the mandibular arch at baseline was 8.5 ± 3.8 mm (95% CI, 7.6 to 9.3) with no significant difference between groups (P = 0.73). For the total sample, mean irregularity index at initial alignment was 2.7 ± 2.8 mm (95% CI, 2.2 to 3.4) with no significant difference between groups (P = 0.40). Mean time from baseline to initial alignment was 59 ± 25 d (95% CI, 54.5 to 65.6); from initial to final alignment, 150 ± 62.5 d (95% CI, 136 to 165); and baseline to final alignment, 209 ± 65 d (95% CI, 195 to 224). Kaplan-Meier analysis demonstrated that patterns of alignment were not significantly different among the 3 groups (P = 0.66). Multivariate linear regression for initial and overall alignment rates using initial irregularity index as the covariate showed no significant differences among groups. The most important influence on both initial and overall rates of alignment was initial irregularity (P = 0.1 × 10(-4)). This prospective randomized clinical trial found no evidence that supplemental vibrational force can significantly increase the rate of initial tooth movement or reduce the amount of time required to achieve final alignment

  17. PREVENTion of a parastomal hernia with a prosthetic mesh in patients undergoing permanent end-colostomy; the PREVENT-trial: study protocol for a multicenter randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Brandsma Henk-Thijs

    2012-11-01

    Full Text Available Abstract Background Parastomal hernia is a common complication of a colostomy. Ultimately, one-third of patients with a parastomal hernia will need surgical correction due to frequent leakage or life-threatening bowel obstruction or strangulation. However, treatment remains a challenge resulting in high recurrence rates. Two single center trials demonstrated that the frequency of parastomal hernias decreases by prophylactic placement of a mesh around the stoma at the time of formation. Unfortunately, both studies were small-sized, single-center studies and with these small numbers less common complications could be missed which were the reasons to initiate a prospective randomized multicenter trial to determine if a retromuscular, preperitoneal mesh at the stoma site prevents parastomal hernia and does not cause unacceptable complications. Methods One hundred and fifty patients undergoing open procedure, elective formation of a permanent end-colostomy will be randomized into two groups. In the intervention group an end-colostomy is created with placement of a preperitioneal, retromuscular lightweight monofilament polypropylene mesh, and compared to a group with a traditional stoma without mesh. Patients will be recruited from 14 teaching hospitals in the Netherlands during a 2-year period. Primary endpoint is the incidence of parastomal hernia. Secondary endpoints are stoma complications, cost-effectiveness, and quality of life. Follow-up will be performed at 3 weeks, 3 months and at 1, 2, and 5 years. To find a difference of 20% with a power of 90%, a total number of 134 patients must be included. All results will be reported according to the CONSORT 2010 statement. Discussion The PREVENT-trial is a multicenter randomized controlled trial powered to determine whether prophylactic placement of a polypropylene mesh decreases the incidence of a parastomal hernia versus the traditional stoma formation without a mesh. Trial registration The PREVENT-trial

  18. Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial

    DEFF Research Database (Denmark)

    Kappos, Ludwig; Freedman, Mark S; Polman, Chris H;

    2009-01-01

    with interferon beta-1b on time to clinically definite multiple sclerosis (CDMS) and other disease outcomes, including disability progression. METHODS: Patients with a first event suggestive of multiple sclerosis and a minimum of two clinically silent lesions in MRI were randomly assigned to receive...... interferon beta-1b 250 microg (n=292; early treatment) or placebo (n=176; delayed treatment) subcutaneously every other day for 2 years, or until diagnosis of CDMS. All patients were then eligible to enter a prospectively planned follow-up phase with open-label interferon beta-1b up to a maximum of 5 years...... 125 in both groups. No significant differences in other disability related outcomes were recorded. Frequency and severity of adverse events remained within the established safety and tolerability profile of interferon beta-1b. INTERPRETATION: Effects on the rate of conversion to CDMS and the...

  19. 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.

  20. Incorporating Contact Network Structure in Cluster Randomized Trials

    CERN Document Server

    Staples, Patrick C; Onnela, Jukka-Pekka

    2015-01-01

    Whenever possible, the efficacy of a new treatment, such as a drug or behavioral intervention, is investigated by randomly assigning some individuals to a treatment condition and others to a control condition, and comparing the outcomes between the two groups. Often, when the treatment aims to slow an infectious disease, groups or clusters of individuals are assigned en masse to each treatment arm. The structure of interactions within and between clusters can reduce the power of the trial, i.e. the probability of correctly detecting a real treatment effect. We investigate the relationships among power, within-cluster structure, between-cluster mixing, and infectivity by simulating an infectious process on a collection of clusters. We demonstrate that current power calculations may be conservative for low levels of between-cluster mixing, but failing to account for moderate or high amounts can result in severely underpowered studies. Power also depends on within-cluster network structure for certain kinds of i...

  1. [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.

  2. Coblation versus traditional tonsillectomy: A double blind randomized ontrolled trial

    Directory of Open Access Journals (Sweden)

    Mohammadreza Omrani

    2012-01-01

    Full Text Available Background: Coblation tonsillectomy is a new surgical technique and demands further research to be proven as a suitable and standard method of tonsillectomy. This study compares coblation and traditional tonsillectomy techniques in view of their advantages and complications. Methods: In a prospective double-blind randomized controlled trial information on operation time, intraoperative blood loss, postoperative pain, time needed to regain the normal diet and activity and post-operative hemorrhage were gathered and compared between two groups containing 47 patients in each group. Results: We found statistically significant differences in operation time (p 0.5 was not significantly different between two groups. Conclusions: This study revealed a significantly less intraoperative or postoperative complications and morbidity in coblation tonsillectomy in comparison with traditional method. Coblation was associated with less pain and quick return to normal diet and daily activity. These findings addressed coblation tonsillectomy as an advanced method.

  3. The conflict between randomized clinical trials and the therapeutic obligation.

    Science.gov (United States)

    Gifford, F

    1986-11-01

    The central dilemma concerning randomized clinical trials (RCTs) arises out of some simple facts about causal methodology (RCTs are the best way to generate the reliable causal knowledge necessary for optimally-informed action) and a prima facie plausible principle concerning how physicians should treat their patients (always do what it is most reasonable to believe will be best for the patient). A number of arguments related to this in the literature are considered. Attempts to avoid the dilemma fail. Appeals to informed consent and mechanisms for minimizing the resulting harm are important for policy, but informed consent is problematic and mechanisms for minimization of harm do not address the dilemma. Appeals to some sort of contract model of justification are promising and illuminating.

  4. Properties of permuted-block randomization in clinical trials.

    Science.gov (United States)

    Matts, J P; Lachin, J M

    1988-12-01

    This article describes some of the important statistical properties of the commonly used permuted-block design, also known simply as blocked-randomization. Under a permutation model for statistical tests, proper analyses should employ tests that incorporate the blocking used in the randomization. These include the block-stratified Mantel-Haenszel chi-square test for binary data, the blocked analysis of variance F test, and the blocked nonparametric linear rank test. It is common, however, to ignore the blocking in the analysis. For these tests, it is shown that the size of a test obtained from an analysis incorporating the blocking (say T), versus an analysis ignoring the blocking (say TI), is related to the intrablock correlation coefficient (R) as TI = T(1-R). For blocks of common length 2m, the range of R is from -1/(2m-1) to 1. Thus, if there is a positive intrablock correlation, which is more likely than not for m greater than 1, an analysis ignoring blocking will be unduly conservative. Permutation tests are also presented for the case of stratified analyses within one or more subgroups of patients defined post hoc on the basis of a covariate. This provides a basis for the analysis when responses from some patients are assumed to be missing-at-random. An alternative strategy that requires no assumptions is to perform the analysis using only the subset of complete blocks in which no observations are missing. The Blackwell-Hodges model is used to assess the potential for selection bias induced by investigator attempts to guess which treatment is more likely to be assigned to each incoming patient. In an unmasked trial, the permuted-block design provides substantial potential for selection bias in the comparison of treatments due to the predictability of the assignments that is induced by the requirement of balance within blocks. Further, this bias is not eliminated by the use of random block sizes. We also modify the Blackwell-Hodges model to allow for

  5. Improving Osteoporosis Screening: Results from a Randomized Cluster Trial

    Science.gov (United States)

    Kolk, Deneil; Peterson, Edward L.; McCarthy, Bruce D.; Weiss, Thomas W.; Chen, Ya-Ting; Muma, Bruce K.

    2007-01-01

    Background Despite recommendations, osteoporosis screening rates among women aged 65 years and older remain low. We present results from a clustered, randomized trial evaluating patient mailed reminders, alone and in combination with physician prompts, to improve osteoporosis screening and treatment. Methods Primary care clinics (n = 15) were randomized to usual care, mailed reminders alone, or mailed reminders with physician prompts. Study patients were females aged 65–89 years (N = 10,354). Using automated clinical and pharmacy data, information was collected on bone mineral density testing, pharmacy dispensings, and other patient characteristics. Unadjusted/adjusted differences in testing and treatment were assessed using generalized estimating equation approaches. Results Osteoporosis screening rates were 10.8% in usual care, 24.1% in mailed reminder, and 28.9% in mailed reminder with physician prompt. Results adjusted for differences at baseline indicated that mailed reminders significantly improved testing rates compared to usual care, and that the addition of prompts further improved testing. This effect increased with patient age. Treatment rates were 5.2% in usual care, 8.4% in mailed reminders, and 9.1% in mailed reminders with prompt. No significant differences were found in treatment rates between those receiving mailed reminders alone or in combination with physician prompts. However, women receiving usual care were significantly less likely to be treated. Conclusions The use of mailed reminders, either alone or with physician prompts, can significantly improve osteoporosis screening and treatment rates among insured primary care patients (Clinical Trials.gov number NCT00139425). PMID:17356966

  6. 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). PMID:26202996

  7. Dialysis fistula or graft: the role for randomized clinical trials.

    Science.gov (United States)

    Allon, Michael; Lok, Charmaine E

    2010-12-01

    The Fistula First Initiative has strongly encouraged nephrologists, vascular access surgeons, and dialysis units in the United States to make valiant efforts to increase fistula use in the hemodialysis population. Unfortunately, the rigid "fistula first" recommendations are not based on solid, current, evidence-based data and may be harmful to some hemodialysis patients by subjecting them to prolonged catheter dependence with its attendant risks of bacteremia and central vein stenosis. Once they are successfully cannulated for dialysis, fistulas last longer than grafts and require fewer interventions to maintain long-term patency for dialysis. However, fistulas have a much higher primary failure rate than grafts, require more interventions to achieve maturation, and entail longer catheter dependence, thereby leading to more catheter-related complications. Given the tradeoffs between fistulas and grafts, there is equipoise about their relative merits in patients with moderate to high risk of fistula nonmaturation. The time is right for definitive, large, multicenter randomized clinical trials to compare fistulas and grafts in various subsets of chronic kidney disease patients. Until the results of such clinical trials are known, the optimal vascular access for a given patients should be determined by the nephrologist and access surgeon by taking into account (1) whether dialysis has been initiated, (2) the patient's life expectancy, (3) whether the patient has had a previous failed vascular access, and (4) the likelihood of fistula nonmaturation. Careful clinical judgment should optimize vascular access outcomes and minimize prolonged catheter dependence among hemodialysis patients. PMID:21030576

  8. Anethum graveolens and hyperlipidemia: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Mahmoud Mirhosseini

    2014-01-01

    Full Text Available Background: It has been established that hyperlipidemia increases the incidence and mortality associated with coronary heart disease. In this study, the effects of Dill (Anethum graveolens were evaluated on lipid profile of hypercholesterolemic patients. Materials and Methods: In this clinical study, 91 hyperlipidemic patients were randomly designated into two groups. One group received gemfibrozil (900 mg daily and the other group received Dill tablet (six tablets daily for 2 months. The blood lipids including total cholesterol, triglyceride and high density lipoprotein (HDL-cholesterol from each group were assessed at the beginning and end of the trial. Results: Use of gemfibrozil brought about increased HDL-cholesterol by 3.91% (P < 0.05 and reduced triglyceride and total cholesterol by 32.7% (P < 0.05 and 9.41% (P < 0.05, respectively. Applying Dill tablet for 2 months resulted in reduction of total cholesterol up to 18% (P < 0.05 and triglyceride by 7.38% (P < 0.05. However, circulating HDL-cholesterol was not affected by this treatment. In this study, gemfibrozil decreased triglyceride and increased HDL-cholesterol more than anethum (P < 0.05. Anethum decreased total cholesterol more than gemfibrozil (P < 0.05. Patients treated with anethum did not report any side effects. Conclusion: The results of this trial indicate that Dill might be beneficial for hypercholesterolemic and hypertriglycemic patients.

  9. A 3-year randomized therapeutic trial of nitisinone in alkaptonuria.

    Science.gov (United States)

    Introne, Wendy J; Perry, Monique B; Troendle, James; Tsilou, Ekaterini; Kayser, Michael A; Suwannarat, Pim; O'Brien, Kevin E; Bryant, Joy; Sachdev, Vandana; Reynolds, James C; Moylan, Elizabeth; Bernardini, Isa; Gahl, William A

    2011-08-01

    Alkaptonuria is a rare, autosomal recessive disorder of tyrosine degradation due to deficiency of the third enzyme in the catabolic pathway. As a result, homogentisic acid (HGA) accumulates and is excreted in gram quantities in the urine, which turns dark upon alkalization. The first symptoms, occurring in early adulthood, involve a painful, progressively debilitating arthritis of the spine and large joints. Cardiac valvular disease and renal and prostate stones occur later. Previously suggested therapies have failed to show benefit, and management remains symptomatic. Nitisinone, a potent inhibitor of the second enzyme in the tyrosine catabolic pathway, is considered a potential therapy; proof-of-principle studies showed 95% reduction in urinary HGA. Based on those findings, a prospective, randomized clinical trial was initiated in 2005 to evaluate 40 patients over a 36-month period. The primary outcome parameter was hip total range of motion with measures of musculoskeletal function serving as secondary parameters. Biochemically, this study consistently demonstrated 95% reduction of HGA in urine and plasma over the course of 3 years. Clinically, primary and secondary parameters did not prove benefit from the medication. Side effects were infrequent. This trial illustrates the remarkable tolerability of nitisinone, its biochemical efficacy, and the need to investigate its use in younger individuals prior to development of debilitating arthritis. PMID:21620748

  10. 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....

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

    DEFF Research Database (Denmark)

    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...

  12. Enhancing antiepileptic drug adherence: a randomized controlled trial.

    Science.gov (United States)

    Brown, Ian; Sheeran, Paschal; Reuber, Markus

    2009-12-01

    Suboptimal adherence to antiepileptic drug (AED) treatment is commonplace, and increases the risk of status epilepticus and sudden unexplained death in epilepsy. This randomized controlled trial was designed to demonstrate whether an implementation intention intervention involving the completion of a simple self-administered questionnaire linking the intention of taking medication with a particular time, place, and other activity can improve AED treatment schedule adherence. Of the 81 patients with epilepsy who were randomized, 69 completed a 1-month monitoring period with an objective measure of tablet taking (electronic registration of pill bottle openings, Medication Event Monitoring System [MEMS]). Intervention participants showed improved adherence relative to controls on all three outcomes: doses taken in total (93.4% vs. 79.1%), days on which correct dose was taken (88.7% vs. 65.3%), and doses taken on schedule (78.8% vs. 55.3%) (Pintention intervention may be an easy-to-administer and effective means of promoting AED adherence. PMID:19864187

  13. Randomized clinical trial comparing abluminal biodegradable polymer sirolimus-eluting stents with durable polymer sirolimus-eluting stents

    Science.gov (United States)

    Zhang, Haijun; Wang, Xiangfei; Deng, Wei; Wang, Shenguo; Ge, Junbo; Toft, Egon

    2016-01-01

    Abstract Background: The biodegradable polymer drug-eluting stents (DES) were developed to improve vascular healing. However, further data and longer-term follow-up are needed to confirm safety and efficacy of these stents. This randomized clinical trial aimed to compare safety and efficacy of 2 sirolimus-eluting stents (SES): Cordimax—a novel abluminal biodegradable polymer SES and Cypher Select—a durable polymer SES, at 9 months angiographic and 5-year clinical follow-up. Methods: We randomized 402 patients with coronary artery disease to percutaneous coronary intervention with Cordimax (n = 202) or Cypher select (n = 200). Angiographic follow-up was performed at 9 months after the index procedure and clinical follow-up annually up to 5 years. The primary endpoint was angiographic in-stent late luminal loss (LLL). Secondary endpoints included angiographic restenosis rate, target vessel revascularization (TVR), and major adverse cardiac events (MACEs; defined as cardiac death, myocardial infarction, or TVR) at 5-year follow-up. Results: Cordimax was noninferior to Cypher select for in-stent LLL (0.25 ± 0.47 vs 0.18 ± 0.49 mm; P = 0.587) and in-stent mean diameter stenosis (22.19 ± 12.21% vs 19.89 ± 10.79%; P = 0.064) at 9 months angiographic follow-up. The MACE rates were not different at 1 year (5.9% vs 4.0%, P = 0.376); however, MACE rates from 2 to 5 years were lower in the Cordimax group (6.8% vs 13.1%; P = 0.039). Conclusion: Abluminal biodegradable polymer SES is noninferior to durable polymer SES at 9-month angiographic and 1-year clinical follow-up. However, MACE rates from 2 to 5 years were less in the abluminal biodegradable polymer group. PMID:27661023

  14. Developmental milestones record - 5 years

    Science.gov (United States)

    ... view (but may not understand them) Has improved math skills Questions others, including parents Strongly identifies with ... milestones for children - 5 years References Feigelman S. The preschool years. In: Kliegman RM, Behrman RE, Jenson HB, ...

  15. Cognitive function in postmenopausal women receiving adjuvant letrozole or tamoxifen for breast cancer in the BIG 1-98 randomized trial

    OpenAIRE

    Phillips, Kelly Anne; Ribi, Karin; Sun, Zhuoxin; Stephens, Alisa; Thompson, Alastair; Harvey, Vernon; Thürlimann, Beat; Cardoso, Fatima; Pagani, Olivia; Coates, Alan S.; Goldhirsch, Aron; Price, Karen N.; Gelber, Richard D; Bernhard, Jürg

    2010-01-01

    Cognitive function in postmenopausal women receiving letrozole or tamoxifen as adjuvant endocrine treatment was compared during the fifth year of treatment in a substudy of the BIG 1-98 trial. In BIG 1-98 patients were randomized to receive adjuvant A) 5-years tamoxifen, B) 5-years letrozole, C) 2-years tamoxifen followed by 3-years letrozole, or D) 2-years letrozole followed by 3-years tamoxifen. The primary comparison was the difference in composite score for patients taking letrozole (B+C;...

  16. Prosthetic heart valves: Objective Performance Criteria versus randomized clinical trial.

    Science.gov (United States)

    Grunkemeier, Gary L; Jin, Ruyun; Starr, Albert

    2006-09-01

    The current Food and Drug Administration (FDA) heart valve guidance document uses an objective performance criteria (OPC) methodology to evaluate the clinical performance of prosthetic heart valves. OPC are essentially historical controls, but they have turned out to be an adequate, and perhaps optimal, study design in this situation. Heart valves have a simple open-and-close mechanism, device effectiveness is easy to document, and the common complications (thromboembolism, thrombosis, bleeding, leak, and infection) are well known and easily detected. Thus, randomized clinical trials (RCTs) have not been deemed necessary for the regulatory approval of prosthetic heart valves. The OPC are derived from the average complication rates of all approved heart valves. Studies based on OPC have been shown to work well; many different valve models have gained FDA market approval based on this methodology. Although heart valve RCTs are not required by the FDA, they have been done to compare valves or treatment regimens after approval. Recently, the Artificial Valve Endocarditis Reduction Trial (AVERT) was designed to compare a new Silzone sewing ring, designed to reduce infection, with the Standard sewing ring on a St. Jude Medical heart valve. This was the largest heart valve RCT ever proposed (4,400 valve patients, followed for as long as 4 years), but it was stopped prematurely because of a high leak rate associated with the Silzone valve. Examining the results showed that a much smaller, OPC-based study with 800 patient-years would have been sufficient to disclose this complication of the Silzone valve. PMID:16928482

  17. Effectiveness of an intervention to reduce sickness absence in patients with emotional distress or minor mental disorders: a randomized controlled effectiveness trial.

    OpenAIRE

    Brouwers, E.P.M.; Tiemens, B.G.; Terluin, B.; Verhaak, P.F.M.

    2006-01-01

    OBJECTIVE: The purpose of this study was to evaluate the effectiveness of an activating intervention designed to reduce sick leave duration in patients with emotional distress or minor mental disorders. METHOD: In a 1.5-year randomized controlled trial, 194 patients with minor mental disorders received either an experimental intervention by social workers or general practitioners' usual care. The intervention focused on understanding causes, developing and implementing problem-solving strateg...

  18. A comparison of imputation strategies in cluster randomized trials with missing binary outcomes.

    Science.gov (United States)

    Caille, Agnès; Leyrat, Clémence; Giraudeau, Bruno

    2014-04-01

    In cluster randomized trials, clusters of subjects are randomized rather than subjects themselves, and missing outcomes are a concern as in individual randomized trials. We assessed strategies for handling missing data when analysing cluster randomized trials with a binary outcome; strategies included complete case, adjusted complete case, and simple and multiple imputation approaches. We performed a simulation study to assess bias and coverage rate of the population-averaged intervention-effect estimate. Both multiple imputation with a random-effects logistic regression model or classical logistic regression provided unbiased estimates of the intervention effect. Both strategies also showed good coverage properties, even slightly better for multiple imputation with a random-effects logistic regression approach. Finally, this latter approach led to a slightly negatively biased intracluster correlation coefficient estimate but less than that with a classical logistic regression model strategy. We applied these strategies to a real trial randomizing households and comparing ivermectin and malathion to treat head lice. PMID:24713160

  19. Sentence retrieval for abstracts of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Chung Grace Y

    2009-02-01

    Full Text Available Abstract Background The practice of evidence-based medicine (EBM requires clinicians to integrate their expertise with the latest scientific research. But this is becoming increasingly difficult with the growing numbers of published articles. There is a clear need for better tools to improve clinician's ability to search the primary literature. Randomized clinical trials (RCTs are the most reliable source of evidence documenting the efficacy of treatment options. This paper describes the retrieval of key sentences from abstracts of RCTs as a step towards helping users find relevant facts about the experimental design of clinical studies. Method Using Conditional Random Fields (CRFs, a popular and successful method for natural language processing problems, sentences referring to Intervention, Participants and Outcome Measures are automatically categorized. This is done by extending a previous approach for labeling sentences in an abstract for general categories associated with scientific argumentation or rhetorical roles: Aim, Method, Results and Conclusion. Methods are tested on several corpora of RCT abstracts. First structured abstracts with headings specifically indicating Intervention, Participant and Outcome Measures are used. Also a manually annotated corpus of structured and unstructured abstracts is prepared for testing a classifier that identifies sentences belonging to each category. Results Using CRFs, sentences can be labeled for the four rhetorical roles with F-scores from 0.93–0.98. This outperforms the use of Support Vector Machines. Furthermore, sentences can be automatically labeled for Intervention, Participant and Outcome Measures, in unstructured and structured abstracts where the section headings do not specifically indicate these three topics. F-scores of up to 0.83 and 0.84 are obtained for Intervention and Outcome Measure sentences. Conclusion Results indicate that some of the methodological elements of RCTs are

  20. Control of Blood Pressure and Risk Attenuation: Post Trial Follow-Up of Randomized Groups.

    Directory of Open Access Journals (Sweden)

    Tazeen H Jafar

    Full Text Available Evidence on long term effectiveness of public health strategies for lowering blood pressure (BP is scarce. In the Control of Blood Pressure and Risk Attenuation (COBRA Trial, a 2 x 2 factorial, cluster randomized controlled trial, the combined home health education (HHE and trained general practitioner (GP intervention delivered over 2 years was more effective than no intervention (usual care in lowering systolic BP among adults with hypertension in urban Pakistan. However, it was not clear whether the effect would be sustained after the cessation of intervention. We conducted 7 years follow-up inclusive of 5 years of post intervention period of COBRA trial participants to assess the effectiveness of the interventions on BP during extended follow-up.A total of 1341 individuals 40 years or older with hypertension (systolic BP 140 mm Hg or greater, diastolic BP 90 mm Hg or greater, or already receiving treatment were followed by trained research staff masked to randomization status. BP was measured thrice with a calibrated automated device (Omron HEM-737 IntelliSense in the sitting position after 5 minutes of rest. BP measurements were repeated after two weeks. Generalized estimating equations (GEE were used to analyze the primary outcome of change in systolic BP from baseline to 7- year follow-up. The multivariable model was adjusted for clustering, age at baseline, sex, baseline systolic and diastolic BP, and presence of diabetes.After 7 years of follow-up, systolic BP levels among those randomised to combined HHE plus trained GP intervention were significantly lower (2.1 [4.1-0.1] mm Hg compared to those randomised to usual care, (P = 0.04. Participants receiving the combined intervention compared to usual care had a greater reduction in LDL-cholesterol (2.7 [4.8 to 0.6] mg/dl.The benefit in systolic BP reduction observed in the original cohort assigned to the combined intervention was attenuated but still evident at 7- year follow-up. These

  1. 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 fa

  2. 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.

  3. Funding, disease area, and internal validity of hepatobiliary randomized clinical trials

    DEFF Research Database (Denmark)

    Kjaergard, Lise Lotte; Gluud, Christian

    2002-01-01

    The aim of this study was to assess whether funding and the disease area are related to the internal validity of hepatobiliary randomized clinical trials.......The aim of this study was to assess whether funding and the disease area are related to the internal validity of hepatobiliary randomized clinical trials....

  4. Systematic review of randomized trials on vasoconstrictor drugs for hepatorenal syndrome

    DEFF Research Database (Denmark)

    Gluud, Lise L; Christensen, Kurt; Christensen, Erik;

    2010-01-01

    . Eligible trials were identified through electronic and manual searches. Intention-to-treat random effects meta-analyses were performed. Ten randomized trials on terlipressin alone or with albumin, octreotide plus albumin, and noradrenalin plus albumin were included. The total number of patients was 376...

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

    OpenAIRE

    Stewart, David J; Kurzrock, Razelle

    2013-01-01

    Abstract 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 differ...

  6. Childhood Fruit and Vegetable Intake: A Randomized Trial

    Directory of Open Access Journals (Sweden)

    Rafaela Rosário

    2012-01-01

    Full Text Available Our study aimed to assess the impact of a six-months nutrition program, taught by trained teachers, on fruit and vegetable consumption among children in grades 1 to 4. Four hundred and sixty-four children (239 female, 6 to 12 years old, from seven elementary schools were assigned to this randomized trial. Teachers were trained by researchers over six months, according to the following topics: nutrition, healthy eating, and strategies to increase physical activity. After each session, teachers were encouraged to develop activities in the classroom on the topics learned. Children's sociodemographic, anthropometric, dietary, and physical activity data were assessed at baseline and at the end of the intervention. The effect sizes ranged between small (Cohen's d=0.12 on “other vegetables” to medium (0.56 on “fruit and vegetable”, and intervened children reported a significantly higher consumption of vegetables and fruit. Interventions involving trained teachers offer promise to increase consumption of fruit and vegetable in children.

  7. Evaluating cognitive effort in a randomized controlled trial.

    Science.gov (United States)

    Turner, Travis H; Renfroe, Jenna B; Morella, Kristen; Marriott, Bernadette P

    2016-09-01

    Many randomized controlled trials (RCTs) of neuropsychiatric conditions involve cognitive outcome measures; however, validity of cognitive data relies on adequate effort during testing, and such screening is seldom performed. Given well-established rates of 10 to 30% poor effort in clinical settings, this is not a trivial concern. This preliminary study evaluated effort during cognitive testing in an RCT of omega-3 supplementation to reduce suicidality in a high-risk psychiatric population. An interim analysis of sustained attentions measures from the Connors Performance Test (CPT-2) at baseline for the first 60 participants was conducted. Previously validated cut points to detect insufficient effort on the CPT-2 were applied. At baseline, 12% (7) were identified as giving poor effort. Follow-up analyses indicated less psychiatric distress and suicidality among those who gave poor effort. Results suggest comparable likelihood of a poor effort on cognitive testing in clinical and RCT participation. Reduced psychiatric distress in the poor effort group raises concern regarding interpretation of other measures. The importance of screening cognitive data for effort in RCTs is highlighted. Future studies will examine effort at follow-up visits, and explore relationships to attrition, adherence, and response to treatment. Copyright © 2016 John Wiley & Sons, Ltd.

  8. A randomized trial of dietary sodium restriction in CKD.

    Science.gov (United States)

    McMahon, Emma J; Bauer, Judith D; Hawley, Carmel M; Isbel, Nicole M; Stowasser, Michael; Johnson, David W; Campbell, Katrina L

    2013-12-01

    There is a paucity of quality evidence regarding the effects of sodium restriction in patients with CKD, particularly in patients with pre-end stage CKD, where controlling modifiable risk factors may be especially important for delaying CKD progression and cardiovascular events. We conducted a double-blind placebo-controlled randomized crossover trial assessing the effects of high versus low sodium intake on ambulatory BP, 24-hour protein and albumin excretion, fluid status (body composition monitor), renin and aldosterone levels, and arterial stiffness (pulse wave velocity and augmentation index) in 20 adult patients with hypertensive stage 3-4 CKD as phase 1 of the LowSALT CKD study. Overall, salt restriction resulted in statistically significant and clinically important reductions in BP (mean reduction of systolic/diastolic BP, 10/4 mm Hg; 95% confidence interval, 5 to 15 /1 to 6 mm Hg), extracellular fluid volume, albuminuria, and proteinuria in patients with moderate-to-severe CKD. The magnitude of change was more pronounced than the magnitude reported in patients without CKD, suggesting that patients with CKD are particularly salt sensitive. Although studies with longer intervention times and larger sample sizes are needed to confirm these benefits, this study indicates that sodium restriction should be emphasized in the management of patients with CKD as a means to reduce cardiovascular risk and risk for CKD progression.

  9. Fundamentals of randomized clinical trials in wound care: reporting standards.

    Science.gov (United States)

    Brölmann, Fleur E; Eskes, Anne M; Sumpio, Bauer E; Mayer, Dieter O; Moore, Zena; Agren, Magnus S; Hermans, Michel; Cutting, Keith; Legemate, Dink A; Vermeulen, Hester; Ubbink, Dirk T

    2013-01-01

    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. 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. 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 in wound care research are addressed in this article. The proposed reporting standards can be used as guidance for authors who write their RCT, as well as for peer reviewers of journals. Endorsement and application of these reporting standards may help achieve a higher standard of evidence and allow meta-analysis of reported wound care data. The ultimate goal is to help wound care professionals make better decisions for their patients in clinical practice.

  10. Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trial

    OpenAIRE

    Maruani, Annabel; Boutron, Isabelle; Baron, Gabriel; Ravaud, Philippe

    2014-01-01

    Objective 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. Design Cohort embedded pragmatic randomized controlled trial. Setting Trials registered on ClinicalTrials.gov. Participants 190 out of 379 trials randomly selected by computer generated randomization list to receive the intervention (personalized emails s...

  11. Pregnant womens' concerns when invited to a randomized trial : a qualitative case control study

    NARCIS (Netherlands)

    Oude Rengerink, Katrien; Logtenberg, Sabine; Hooft, Lotty; Bossuyt, Patrick M; Mol, Ben Willem; Oude Rengerink, K

    2015-01-01

    BACKGROUND: Pregnant women were excluded from clinical trials until the 1990s, but the Food and Drug Administration nowadays allows--and even encourages--responsible inclusion of pregnant women in trials with adequate safety monitoring. Still, randomized trials in pregnant women face specific enrolm

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

    OpenAIRE

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

    2009-01-01

    To summarize and evaluate all publications including cluster-randomized trials used for maternal and child health research in developing countries during the last 10 years.METHODS:All cluster-randomized trials published between 1998 and 2008 were reviewed, and those that met our criteria for inclusion were evaluated further. The criteria for inclusion were that the trial should have been conducted in maternal and child health care in a developing country and that the conclusions should have b...

  13. Randomized clinical trial comparing percutaneous closure of patent foramen ovale (PFO using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic embolism (PC-Trial: rationale and design

    Directory of Open Access Journals (Sweden)

    Schuler Gerhard

    2011-02-01

    Full Text Available Abstract Background Several studies have shown an association of cryptogenic stroke and embolism with patent foramen ovale (PFO, but the question how to prevent further events in such patients is unresolved. Options include antithrombotic treatment with warfarin or antiplatelet agents or surgical or endovascular closure of the PFO. The PC-Trial was set up to compare endovascular closure and best medical treatment for prevention of recurrent events. Methods The PC-Trial is a randomized clinical trial comparing the efficacy of percutaneous closure of the PFO using the Amplatzer PFO occluder with best medical treatment in patients with cryptogenic embolism, i.e. mostly cryptogenic stroke. Warfarin for 6 months followed by antiplatelet agents is recommended as medical treatment. Randomization is stratified according to patients age ( Discussion patients were randomized in 29 centers of Europe, Canada, and Australia. Randomization started February 2000. Enrollment of 414 patients was completed in February 2009. All patients will be followed-up longitudinally. Follow-up is maintained until the last enrolled patient is beyond 2.5 years of follow-up (expected in 2011. Trial Registration Trial listed in ClinicalTrials.gov as NCT00166257 and sponsored by AGA Medical, Plymouth, MN, USA

  14. African HIV/AIDS trials are more likely to report adequate allocation concealment and random generation than North American trials.

    Directory of Open Access Journals (Sweden)

    Nandi Siegfried

    Full Text Available BACKGROUND: Adherence to good methodological quality is necessary to minimise bias in randomised conrolled trials (RCTs. Specific trial characteristics are associated with better trial quality, but no studies to date are specific to HIV/AIDS or African trials. We postulated that location may negatively impact on trial quality in regions where resources are scarce. METHODS: 1 To compare the methodological quality of all HIV/AIDS RCTs conducted in Africa with a random sample of similar trials conducted in North America; 2 To assess whether location is predictive of trial quality. We searched MEDLINE, EMBASE, CENTRAL and LILACS. Eligible trials were 1 randomized, 2 evaluations of preventive or treatment interventions for HIV/AIDS, 3 reported before 2004, and 4 conducted wholly or partly (if multi-centred in Africa or North America. We assessed adequacy of random generation, allocation concealment and masking of assessors. Using univariate and multivariate logistic regression analyses we evaluated the association between location (Africa versus North America and these domains. FINDINGS: The African search yielded 12,815 records, from which 80 trials were identified. The North American search yielded 13,158 records from which 785 trials were identified and a random sample of 114 selected for analysis. African trials were three times more likely than North American trials to report adequate allocation concealment (OR = 3.24; 95%CI: 1.59 to 6.59; p<0.01 and twice as likely to report adequate generation of the sequence (OR = 2.36; 95%CI: 1.20 to 4.67; p = 0.01, after adjusting for other confounding factors. Additional significant factors positively associated with quality were an a priori sample size power calculation, restricted randomization and inclusion of a flow diagram detailing attrition. We did not detect an association between location and outcome assessor masking. CONCLUSIONS: The higher quality of reporting of methodology in African trials is

  15. Focus on Function – a randomized controlled trial comparing two rehabilitation interventions for young children with cerebral palsy

    Directory of Open Access Journals (Sweden)

    Russell Dianne

    2007-09-01

    Full Text Available Abstract Background Children with cerebral palsy receive a variety of long-term physical and occupational therapy interventions to facilitate development and to enhance functional independence in movement, self-care, play, school activities and leisure. Considerable human and financial resources are directed at the "intervention" of the problems of cerebral palsy, although the available evidence supporting current interventions is inconclusive. A considerable degree of uncertainty remains about the appropriate therapeutic approaches to manage the habilitation of children with cerebral palsy. The primary objective of this project is to conduct a multi-site randomized clinical trial to evaluate the efficacy of a task/context-focused approach compared to a child-focused remediation approach in improving performance of functional tasks and mobility, increasing participation in everyday activities, and improving quality of life in children 12 months to 5 years of age who have cerebral palsy. Method/Design A multi-centred randomized controlled trial research design will be used. Children will be recruited from a representative sample of children attending publicly-funded regional children's rehabilitation centers serving children with disabilities in Ontario and Alberta in Canada. Target sample size is 220 children with cerebral palsy aged 12 months to 5 years at recruitment date. Therapists are randomly assigned to deliver either a context-focused approach or a child-focused approach. Children follow their therapist into their treatment arm. Outcomes will be evaluated at baseline, after 6 months of treatment and at a 3-month follow-up period. Outcomes represent the components of the International Classification of Functioning, Disability and Health, including body function and structure (range of motion, activities (performance of functional tasks, motor function, participation (involvement in formal and informal activities, and environment (parent

  16. A large-scale field trial of thin-layer capping of PCDD/F-contaminated sediments: Sediment-to-water fluxes up to 5 years post-amendment.

    Science.gov (United States)

    Cornelissen, Gerard; Schaanning, Morten; Gunnarsson, Jonas S; Eek, Espen

    2016-04-01

    The longer-term effect (3-5 y) of thin-layer capping on in situ sediment-to-surface water fluxes was monitored in a large-scale field experiment in the polychlorinated dibenzodioxin and dibenzofuran (PCDD/F) contaminated Grenlandfjords, Norway (4 trial plots of 10,000 to 40,000 m(2) at 30 to 100 m water depth). Active caps (designed thickness 2.5 cm) were established in 2 fjords, consisting of dredged clean clay amended with powdered activated carbon (PAC) from anthracite. These active caps were compared to 2 nonactive caps in one of the fjords (designed thickness 5 cm) consisting of either clay only (i.e., without PAC) or crushed limestone. Sediment-to-water PCDD/F fluxes were measured in situ using diffusion chambers. An earlier study showed that during the first 2 years after thin-layer capping, flux reductions relative to noncapped reference fields were more extensive at the fields capped with nonactive caps (70%-90%) than at the ones with PAC-containing caps (50%-60%). However, the present work shows that between 3 and 5 years after thin-layer capping, this trend was reversed and cap effectiveness in reducing fluxes was increasing to 80% to 90% for the PAC caps, whereas cap effectiveness of the nonactive caps decreased to 20% to 60%. The increasing effectiveness over time of PAC-containing "active" caps is explained by a combination of slow sediment-to-PAC mass transfer of PCDD/Fs and bioturbation by benthic organisms. The decreasing effectiveness of "nonactive" limestone and clay caps is explained by deposition of contaminated particles on top of the caps. The present field data indicate that the capping efficiency of thin active caps (i.e., enriched with PAC) can improve over time as a result of slow diffusive PCDD/F transfer from sediment to PAC particles and better mixing of the PAC by bioturbation. PMID:26012529

  17. Prevention trial in the Cherokee Nation: design of a randomized community trial.

    Science.gov (United States)

    Komro, Kelli A; Wagenaar, Alexander C; Boyd, Misty; Boyd, B J; Kominsky, Terrence; Pettigrew, Dallas; Tobler, Amy L; Lynne-Landsman, Sarah D; Livingston, Melvin D; Livingston, Bethany; Molina, Mildred M Maldonado

    2015-02-01

    Despite advances in prevention science and practice in recent decades, the U.S. continues to struggle with significant alcohol-related risks and consequences among youth, especially among vulnerable rural and Native American youth. The Prevention Trial in the Cherokee Nation is a partnership between prevention scientists and Cherokee Nation Behavioral Health to create, implement, and evaluate a new, integrated community-level intervention designed to prevent underage drinking and associated negative consequences among Native American and other youth living in rural high-risk underserved communities. The intervention builds directly on results of multiple previous trials of two conceptually distinct approaches. The first is an updated version of CMCA, an established community environmental change intervention, and the second is CONNECT, our newly developed population-wide intervention based on screening, brief intervention, and referral to treatment (SBIRT) research. CMCA direct-action community organizing is used to engage local citizens to address community norms and practices related to alcohol use and commercial and social access to alcohol among adolescents. The new CONNECT intervention expands traditional SBIRT to be implemented universally within schools. Six key research design elements optimize causal inference and experimental evaluation of intervention effects, including a controlled interrupted time-series design, purposive selection of towns, random assignment to study condition, nested cohorts as well as repeated cross-sectional observations, a factorial design crossing two conceptually distinct interventions, and multiple comparison groups. The purpose of this paper is to describe the strong partnership between prevention scientists and behavioral health leaders within the Cherokee Nation, and the intervention and research design of this new community trial. PMID:24615546

  18. Blinding Techniques in Randomized Controlled Trials of Laser Therapy: An Overview and Possible Solution

    OpenAIRE

    Marie Pirotta; Roberta Chow; Ian Relf

    2008-01-01

    Low-level laser therapy has evidence accumulating about its effectiveness in a variety of medical conditions. We reviewed 51 double blind randomized controlled trials (RCTs) of laser treatment. Analysis revealed 58% of trials showed benefit of laser over placebo. However, less than 5% of the trials had addressed beam disguise or allocation concealment in the laser machines used. Many of the trials used blinding methods that rely on staff cooperation and are therefore open to interference or b...

  19. Spinal cord stimulation with interleaved pulses: a randomized, controlled trial.

    Science.gov (United States)

    North, Richard B; Kidd, David H; Olin, John; Sieracki, Jeffrey M; Boulay, Marc

    2007-10-01

    Objectives.  The development of multicontact electrodes and programmable, implanted pulse generators has increased the therapeutic success of spinal cord stimulation (SCS) by enhancing the ability to capture and maintain pain/paresthesia overlap. This study sought to determine if interleaved stimulation and/or frequency doubling improves pain/paresthesia overlap in patients with failed back surgery syndrome. Methods.  Using a patient-interactive computer system that quantifies SCS performance and presents stimulation settings in randomized, double-blind fashion, we compared the effect on pain/paresthesia overlap of interleaved stimulation (rapidly interleaved pulse trains using two different contact combinations) vs. standard treatment with a single contact combination, controlling for frequency doubling. Stimulation amplitude (charge per phase, as determined by varying pulse voltage or width) was adjusted to a subjectively comfortable intensity (usage amplitude), which was maintained for all trials in each patient. The number of percutaneous spinal electrodes used (one or two) and the phase angle between interleaved pulses were additional study variables. Results.  Multivariate analysis of 266 test results from 15 patients revealed a statistically significant (p ≤ 0.05) association between increased computer-calculated pain/paresthesia overlap and 1) high- and low-frequency interleaved stimulation using two combinations of contacts and 2) frequency doubling using one combination. We found no significant effect for electrode configuration (single or dual), pulse width matching, or phase angle. Conclusions.  The statistically significant advantages we observed for SCS with interleaved stimulation are explained, at least in part, by the effects of frequency doubling. These findings have important implications for the design and adjustment of pulse generators. PMID:22150894

  20. Prone Breast Intensity Modulated Radiation Therapy: 5-Year Results

    Energy Technology Data Exchange (ETDEWEB)

    Osa, Etin-Osa O.; DeWyngaert, Keith [Department of Radiation Oncology, New York University School of Medicine, New York, New York (United States); Roses, Daniel [Department of Surgery, New York University School of Medicine, New York, New York (United States); Speyer, James [Department of Medical Oncology, New York University School of Medicine, New York, New York (United States); Guth, Amber; Axelrod, Deborah [Department of Surgery, New York University School of Medicine, New York, New York (United States); Fenton Kerimian, Maria [Department of Radiation Oncology, New York University School of Medicine, New York, New York (United States); Goldberg, Judith D. [Department of Population Health, New York University School of Medicine, New York, New York (United States); Formenti, Silvia C., E-mail: Silvia.formenti@nyumc.org [Department of Radiation Oncology, New York University School of Medicine, New York, New York (United States)

    2014-07-15

    Purpose: To report the 5-year results of a technique of prone breast radiation therapy delivered by a regimen of accelerated intensity modulated radiation therapy with a concurrent boost to the tumor bed. Methods and Materials: Between 2003 and 2006, 404 patients with stage I-II breast cancer were prospectively enrolled into 2 consecutive protocols, institutional trials 03-30 and 05-181, that used the same regimen of 40.5 Gy/15 fractions delivered to the index breast over 3 weeks, with a concomitant daily boost to the tumor bed of 0.5 Gy (total dose 48 Gy). All patients were treated after segmental mastectomy and had negative margins and nodal assessment. Patients were set up prone: only if lung or heart volumes were in the field was a supine setup attempted and chosen if found to better spare these organs. Results: Ninety-two percent of patients were treated prone, 8% supine. Seventy-two percent had stage I, 28% stage II invasive breast cancer. In-field lung volume ranged from 0 to 228.27 cm{sup 3}, mean 19.65 cm{sup 3}. In-field heart volume for left breast cancer patients ranged from 0 to 21.24 cm{sup 3}, mean 1.59 cm{sup 3}. There was no heart in the field for right breast cancer patients. At a median follow-up of 5 years, the 5-year cumulative incidence of isolated ipsilateral breast tumor recurrence was 0.82% (95% confidence interval [CI] 0.65%-1.04%). The 5-year cumulative incidence of regional recurrence was 0.53% (95% CI 0.41%-0.69%), and the 5-year overall cumulative death rate was 1.28% (95% CI 0.48%-3.38%). Eighty-two percent (95% CI 77%-85%) of patients judged their final cosmetic result as excellent/good. Conclusions: Prone accelerated intensity modulated radiation therapy with a concomitant boost results in excellent local control and optimal sparing of heart and lung, with good cosmesis. Radiation Therapy Oncology Group protocol 1005, a phase 3, multi-institutional, randomized trial is ongoing and is evaluating the equivalence of a similar dose and

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

    Directory of Open Access Journals (Sweden)

    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

  2. Random assignment in clinical trials: issues in planning (Infant Health and Development Program).

    Science.gov (United States)

    Kraemer, H C; Fendt, K H

    1990-01-01

    Various options available for the randomization of subjects into groups in a clinical trial are discussed, emphasizing the issues of logistics given less focus in more mathematical treatments. We discuss advantages and disadvantages of total randomization, of Zelen-type randomization procedures, of Efron-type procedures vs more classical blocking procedures to control the balance between groups, and of Simon-Pocock-type procedures vs more classical stratification for controlling possible biases in prognostic factors. Finally, we discuss issues related to choice and implementation of randomization procedures. The discussion is illustrated with the processes of decision-making in a national collaborative randomized clinical trial, the Infant Health and Development Program.

  3. Eliminating bias in randomized controlled trials: importance of allocation concealment and masking.

    Science.gov (United States)

    Viera, Anthony J; Bangdiwala, Shrikant I

    2007-02-01

    Randomization in randomized controlled trials involves more than generation of a random sequence by which to assign subjects. For randomization to be successfully implemented, the randomization sequence must be adequately protected (concealed) so that investigators, involved health care providers, and subjects are not aware of the upcoming assignment. The absence of adequate allocation concealment can lead to selection bias, one of the very problems that randomization was supposed to eliminate. Authors of reports of randomized trials should provide enough details on how allocation concealment was achieved so the reader can determine the likelihood of success. Fortunately, a plan of allocation concealment can always be incorporated into the design of a randomized trial. Certain methods minimize the risk of concealment failing more than others. Keeping knowledge of subjects' assignment after allocation from subjects, investigators/health care providers, or those assessing outcomes is referred to as masking (also known as blinding). The goal of masking is to prevent ascertainment bias. In contrast to allocation concealment, masking cannot always be incorporated into a randomized controlled trial. Both allocation concealment and masking add to the elimination of bias in randomized controlled trials.

  4. Register or electronic health records enriched randomized pragmatic trials: The future of clinical effectiveness and cost-effectiveness trials?

    Directory of Open Access Journals (Sweden)

    Joakim Ramsberg

    2015-03-01

    Full Text Available For many interventions in health care, there is limited information on efficacy, safety and cost-effectiveness even long after they have been implemented. To decide between treatments, the randomized controlled trial (RCT provides the strongest evidence. This creates a problem because RCTs are very expensive, logistically challenging and generally cumbersome. Observational studies are inexpensive, but create weaker evidence. The pragmatic randomized trial, enriched with routinely collected register or electronic health record  (EHR data may be a solution to this dilemma since they are much less costly than traditional RCTs but create much stronger evidence than observational studies. Pragmatic randomized trials mean that patients in routine care are randomly allocated to alternative treatments. The outcome of the treatment is then followed up in existing registers with patient data. This means that it is possible to 1 follow patients in the normal care situation - unlike the often artificial situation in the traditional RCT, 2 that the costs are low, even for large studies and 3 that a broad spectrum of outcomes, including both health and economic outcomes, can be collected. Pragmatic randomized trials using register or EHR data in principle lend themselves well to health economic evaluations. We have identified a number of such trials in the literature. Very few, however, include economic outcomes.

  5. Pilot Randomized trial of Fibrinogen in Trauma Haemorrhage (PRooF- iTH): study protocol for a randomized controlled trial

    DEFF Research Database (Denmark)

    Steinmetz, Jacob; Sorensen, Anne Marie; Henriksen, Hanne Hee;

    2016-01-01

    haemorrhage in need of haemostatic resuscitation. METHODS/DESIGN: This is a single-centre, randomized (1:1, active:placebo), placebo-controlled, double-blinded, investigator-initiated phase II trial. The trial population consists of 40 adult patients (>18 years) with traumatic, critical bleeding admitted....../kg fibrinogen concentrate (Riastap®) or placebo 0.9 % saline in equal volume to active treatment, both given as intravenous infusion blinded for the person administering the infusion. The primary end point is the change in thrombelastograph (TEG®) functional fibrinogen maximum amplitude in millimetres at 15 min...... require 19 patients in each group. We have chosen to include 40 patients, 20 evaluable patients in each randomization group in case of attrition, in the present trial. DISCUSSION: Patients considered to be included in the trial will temporarily have a compromised consciousness because of the acute...

  6. Randomized clinical trial of total vs. subtotal hysterectomy

    DEFF Research Database (Denmark)

    Gimbel, Helga; Zobbe, Vibeke; Ottesen, Bent S;

    2002-01-01

    To ensure the internal validity of a trial it is recommended to undertake a validation study of the method measuring the outcome.......To ensure the internal validity of a trial it is recommended to undertake a validation study of the method measuring the outcome....

  7. Interventions for the prevention of overweight and obesity in preschool children: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Monasta, L; Batty, G D; Macaluso, A; Ronfani, L; Lutje, V; Bavcar, A; van Lenthe, F J; Brug, J; Cattaneo, A

    2011-05-01

    The objective of this study was to analyse interventions for the prevention of overweight and obesity in children under 5 years of age. We carried out a systematic review focusing exclusively on randomized controlled trials (RCTs). Data sources include Medline, Cochrane Library, EMBASE, CINHAL, PsychInfo and Web of Science. Data were extracted from seventeen articles describing seven RCTs identified through electronic search, screening of references in systematic reviews, own files and contact with authors. RCTs were assessed with the Jadad scale. Four trials were carried out in preschool settings, one with an exclusive educational component, two with an exclusive physical activity component and one with both. Two trials were family-based, with education and counselling for parents and children. The remaining trial was carried out in maternity hospitals, with a training intervention on breastfeeding. None of the interventions had an effect in preventing overweight and obesity. The failure to show an effect may be due to the choice of outcomes, the quality of the RCTs, the suboptimal implementation of the interventions, the lack of focus on social and environmental determinants. More rigorous research is needed on interventions and on social and environmental factors that could impact on lifestyle.

  8. Safety and preliminary immunogenicity of Cuban pneumococcal conjugate vaccine candidate in healthy children: a randomized phase I clinical trial.

    Science.gov (United States)

    Dotres, Carlos P; Puga, Rinaldo; Ricardo, Yariset; Broño, Carmen R; Paredes, Beatriz; Echemendía, Vladimir; Rosell, Sandra; González, Nadezhda; García-Rivera, Dagmar; Valdés, Yury; Goldblatt, David; Vérez-Bencomo, Vicente

    2014-09-15

    A new heptavalent conjugate vaccine (PCV7-TT) is under development in Cuba. PCV7-TT contains 2 μg of serotypes 1, 5, 14, 18C, 19F, 23F and 4 μg of 6B, each one conjugated to tetanus toxoid (TT). This vaccine was designed with the serotypes that cause most invasive pneumococcal diseases (IPD) worldwide. In the present study, we investigated the safety and explored the immunogenicity of PCV7-TT during a controlled, randomized and double blind clinical trial phase I in 4-5-year-old children. PCV7-TT was well tolerated and as safe as Synflorix used as control vaccine. Following a single-dose vaccination, all individual serotypes included in PCV7-TT induced statistically significant increase of IgG GMC and OPA GMT. These are the first clinical results of PCV7-TT in children and they pave the way toward next clinical trials in children and infants. This clinical trial was published in the Cuban Public Register of Clinical Trials with code RPCEC00000173.

  9. Celecoxib-related gastroduodenal ulcer and cardiovascular events in a randomized trial for gastric cancer prevention

    Institute of Scientific and Technical Information of China (English)

    Guo-Shuang Feng; Harry HX Xia; Ji-You Li; Shiu Kum Lam; Wei-Cheng You; Jun-Ling Ma; Benjamin CY Wong; Lian Zhang; Wei-Dong Liu; Kai-Feng Pan; Lin Shen; Xiao-Dong Zhang; Jie Li

    2008-01-01

    AIM: To evaluate the long-term risk of gastroduodenal ulcer and cardiovascular events induced by celecoxib in a population-based, randomized, double-blind,placebo-controlled study.METHODS: From 2004 to 2006, a total of 1024 Chinese patients (aged 35 to 64 years) with severe chronic atrophic gastritis, intestinal metaplasia or dysplasia were randomly assigned to receive 200 mg of celecoxib twice daily or placebo in Linqu County (Shandong Province, China), a high-risk area of gastric cancer. All gastroduodenal ulcer and cardiovascular events occurred were recorded and the patients were followed up for 1.5 years after treatment. At the end of the trial, a systematic interview survey about other adverse events was conducted.RESULTS: Gastroduodenal ulcer was detected in 19 of 463 (3.72%) patients who Received: celecoxib and 17 of 473 (3.31%) patients who Received placebo,respectively (odds ratio = 1.13, 95% CI = 0.58-2.19).Cardiovascular (CV) events occurred in 4 patients who received celecoxib and in 5 patients who received placebo,respectively.Compared with those who received placebo,patients who received celecoxib had no significant increase in occurrence of Cvevents (hazard ratio = 0.84,95% CI =0.23-3.15).Among the adverse events acquired by interview survey,only the frequency of bloating was significantly higher in patients treated with celecoxib than in those treated with placebo.CONCLUSION:Treatment of gastric cancer with celecoxib is not associated with increased risk of gastroduodenal ulcer and cardiovascular events.

  10. Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer, a randomized controlled trial (ROBOT trial

    Directory of Open Access Journals (Sweden)

    van der Sluis Pieter C

    2012-11-01

    open transthoracic esophagectomy as surgical treatment for resectable esophageal cancer. If our hypothesis is proven correct, RATE will result in a lower percentage of postoperative complications, lower blood loss, and shorter hospital stay, but with at least similar oncologic outcomes and better postoperative quality of life compared with open transthoracic esophagectomy. The study started in January 2012. Follow-up will be 5 years. Short-term results will be analyzed and published after discharge of the last randomized patient. Trial registration Dutch trial register: NTR3291 ClinicalTrial.gov: NCT01544790

  11. A randomized double-blind controlled trial of the use of dydrogesterone in women with threatened miscarriage in the first trimester: study protocol for a randomized controlled trial

    OpenAIRE

    Chan, Diana Man Ka; Cheung, Ka Wang; Yung, Sofie Shuk Fei; Lee, Vivian Chi Yan; Li, Raymond Hang Wun; Ng, Ernest Hung Yu

    2016-01-01

    Background Miscarriage is a common complication of pregnancy occurring in 15–20 % of all clinically recognized pregnancies. Currently, there is still no good scientific evidence to support the routine use of progestogens for the treatment of threatened miscarriage because the existing studies were not large enough to show a significant difference and some of them were not randomized or double-blind. Methods This is a double-blind, randomized controlled trial. A total of 400 patients presentin...

  12. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

    Directory of Open Access Journals (Sweden)

    Marleine Azar

    Full Text Available Confidence that randomized controlled trial (RCT results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP is the primary trials journal amongst American Psychological Association (APA journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1 adequacy of primary outcome analysis definitions; (2 registration status; and, (3 among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals.Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1 adequacy of outcome analysis definitions in the published report, (2 whether the RCT was registered prior to enrolling patients, and (3 adequacy of outcome registration.Of 70 RCTs reviewed, 12 (17.1% adequately defined primary or secondary outcome analyses, whereas 58 (82.3% had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7% registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029. The proportion of registered trials in JCCP (55.7% was comparable to behavioral medicine journals (52.6%; p = 0.709.The quality of published outcome analysis definitions and trial registrations in JCCP is

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

    DEFF Research Database (Denmark)

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

    2009-01-01

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

  14. Arthrocentesis as initial treatment for temporomandibular joint arthropathy : A randomized controlled trial

    NARCIS (Netherlands)

    Vos, L. M.; Huddleston Slater, J. J. R.; Stegenga, B.

    2014-01-01

    Objective: To determine the effectiveness of arthrocentesis compared to conservative treatment as initial treatment with regard to temporomandibular joint pain and mandibular movement. Patients and methods: In this randomized controlled trial, 80 patients with arthralgia of the TMJ (classified accor

  15. Systematic care for caregivers of patients with dementia: a multicenter, cluster-randomized, controlled trial

    NARCIS (Netherlands)

    Spijker, A.; Wollersheim, H.C.H.; Teerenstra, S.; Graff, M.J.L.; Adang, E.M.M.; Verhey, F.; Vernooij-Dassen, M.J.F.J.

    2011-01-01

    OBJECTIVE: To evaluate the effectiveness of the Systematic Care Program for Dementia (SCPD) on patient institutionalization and to determine the predictors of institutionalization. DESIGN: Single-blind, multicenter, cluster-randomized, controlled trial. SETTING: Six community mental health services

  16. A randomized trial on folic acid supplementation and risk of recurrent colorectal adenoma

    Science.gov (United States)

    Background: Evidence from observational studies suggests that inadequate folate status enhances colorectal carcinogenesis, but results from some randomized trials do not support this hypothesis. Objective: To assess the effect of folic acid supplementation on recurrent colorectal adenoma, we conduc...

  17. Predictors of Missed Research Appointments in a Randomized Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Stéphanie J.E. Becker

    2014-09-01

     Younger patients with no college education, who believe their health can be controlled, are more likely to miss a research appointment when enrolled in a randomized placebo injection-controlled trial

  18. Evaluation of occupational health interventions using a randomized controlled trial: challenges and alternative research designs

    NARCIS (Netherlands)

    Schelvis, R.M; Oude Hengel, K.M.; Burdorf, A.; Blatter, B.M.; Strijk, J.E.; Beek, A.J. van

    2015-01-01

    Occupational health researchers regularly conduct evaluative intervention research for which a randomized controlled trial (RCT) may not be the most appropriate design (eg, effects of policy measures, organizational interventions on work schedules). This article demonstrates the appropriateness of a

  19. Client attachment security predicts alliance in a randomized controlled trial of two psychotherapies for bulimia nervosa

    DEFF Research Database (Denmark)

    Folke, Sofie; Daniel, Sarah Ingrid Franksdatter; Poulsen, Stig Bernt;

    2015-01-01

    Objective: This study investigated the relation between clients’ attachment patterns and the therapeutic alliance in two psychotherapies for bulimia nervosa. Method: Data derive from a randomized clinical trial comparing cognitive-behavioral therapy and psychoanalytic psychotherapy for bulimia...

  20. Implementation of the Dutch low back pain guideline for general practitioners: a cluster randomized controlled trial.

    NARCIS (Netherlands)

    Engers, A.J.; Wensing, M.J.P.; Tulder, M.W. van; Timmermans, A.; Oostendorp, R.A.B.; Koes, B.W.; Grol, R.P.T.M.

    2005-01-01

    STUDY DESIGN: Cluster randomized controlled trial for a multifaceted implementation strategy. OBJECTIVES: To assess the effectiveness of tailored interventions (multifaceted implementation strategy) to implement the Dutch low back pain guideline for general practitioners with regard to adherence to

  1. Systemic corticosteroid monotherapy for clinically diagnosed acute rhinosinusitis: a randomized controlled trial

    NARCIS (Netherlands)

    Venekamp, R.P.; Bonten, M.J.; Rovers, M.M.; Verheij, T.J.; Sachs, A.P.

    2012-01-01

    BACKGROUND: Patients with acute rhinosinusitis are frequently encountered in primary care. Although corticosteroids are being increasingly used for symptom control, evidence supporting their use is inconclusive. We conducted a randomized controlled trial to examine the effectiveness of systemic cort

  2. Randomized controlled trial of the Pentax AWS, Glidescope, and Macintosh laryngoscopes in predicted difficult intubation.

    LENUS (Irish Health Repository)

    Malik, M A

    2009-11-01

    The purpose of this study was to determine the potential for the Pentax AWS and the Glidescope to reduce the difficulty of tracheal intubation in patients at increased risk for difficult tracheal intubation, in a randomized, controlled clinical trial.

  3. Fluoxetine for poststroke depression A randomized placebo controlled clinical trial

    Institute of Scientific and Technical Information of China (English)

    Yan Kong; Wanli Dong; Chunfeng Liu

    2007-01-01

    BACKGROUND: Studies have demonstrated that poststroke depression(PSD) may be related with the disequilibrium between noradrenaline and 5-hydroxytryptamine (5-HT) caused by cerebral injury. The injured regions involve noradrenergic and 5-hydroxytryptaminergic neurons as well as conduction pathway.The levels of noradrenaline and 5-HT would be decreased.OBJECTIVE: To observe the effect of fluoxetine on preventing against PSD and recovery of neurologic function, and analyze the relationship of fluoxetine and the 5-HT level.DESIGN: A randomized controlled clinical trial.SETTING: Department of Neurology, First Hospital Affiliated to Soochow University.PARTICIPANTS: Ninety consecutive patients, 47 female and 43 male, were recruited who admitted to hospital for recent stroke in the Department of Neurology, First Affiliated Hospital of Soochow University between September 2003 and February 2005. Subjects were aged (64±7) years, ranging from 47 to 79 years old. They all met the diagnosis criteria of various cerebrovascular diseases formulated in the 4th National Cerebrovascular Disease Conference and confirmed as stroke by skull CT or MRI; The time from onset to tentative administration was less than 7 days; The patients had clear consciousness, without obvious language disorder. They were randomized into treatment group (n =48) and placebo group (n =42).METHODS: ①All the patients were given routine treatment according to treatment guideline of cerebrovascular disease after admission. Patients in the treatment group and placebo group received 20 mg/d fluoxetine and placebo (component: vitamin C) for 8 weeks, respectively. ② Neurologic deficit was assessed according to 24-item Hamilton Rating Scale for Depression (HAMD) and Activity of Daily Living Scale (ADL) before and at 2,4 and 8 weeks after test, separately; Meanwhile, the levels of platelet 5-HT and plasma 5-HT were determined. Grading criteria of HAMD intergral depression: non-depression < 8 points

  4. 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.

  5. A descriptive analysis of a representative sample of pediatric randomized controlled trials published in 2007

    Directory of Open Access Journals (Sweden)

    Thomson Denise

    2010-12-01

    Full Text Available Abstract Background Randomized controlled trials (RCTs are the gold standard for trials assessing the effects of therapeutic interventions; therefore it is important to understand how they are conducted. Our objectives were to provide an overview of a representative sample of pediatric RCTs published in 2007 and assess the validity of their results. Methods We searched Cochrane Central Register of Controlled Trials using a pediatric filter and randomly selected 300 RCTs published in 2007. We extracted data on trial characteristics; outcomes; methodological quality; reporting; and registration and protocol characteristics. Trial registration and protocol availability were determined for each study based on the publication, an Internet search and an author survey. Results Most studies (83% were efficacy trials, 40% evaluated drugs, and 30% were placebo-controlled. Primary outcomes were specified in 41%; 43% reported on adverse events. At least one statistically significant outcome was reported in 77% of trials; 63% favored the treatment group. Trial registration was declared in 12% of publications and 23% were found through an Internet search. Risk of bias (ROB was high in 59% of trials, unclear in 33%, and low in 8%. Registered trials were more likely to have low ROB than non-registered trials (16% vs. 5%; p = 0.008. Effect sizes tended to be larger for trials at high vs. low ROB (0.28, 95% CI 0.21,0.35 vs. 0.16, 95% CI 0.07,0.25. Among survey respondents (50% response rate, the most common reason for trial registration was a publication requirement and for non-registration, a lack of familiarity with the process. Conclusions More than half of this random sample of pediatric RCTs published in 2007 was at high ROB and three quarters of trials were not registered. There is an urgent need to improve the design, conduct, and reporting of child health research.

  6. Cognitive benefits of social dancing and walking in old age: the Dancing Mind randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Dafna eMerom

    2016-02-01

    Full Text Available Background: A physically active lifestyle has the potential to prevent cognitive decline and dementia, yet the optimal type of physical activity/exercise remains unclear. Dance is of special interest as it complex sensorimotor rhythmic activity with additional cognitive, social and affective dimensions. Objectives: to determine whether dance benefits executive function more than walking, an activity that is simple and functional. Methods: Two-arm randomised controlled trial among community-dwelling older adults. The intervention group received 1 hour of ballroom dancing twice weekly over 8 months (~69sessions in local community dance studios. The control group received a combination of a home walking program with a pedometer and optional biweekly group-based walking in local community park to facilitate socialisation. Main outcomes: Main outcomes: executive function tests: processing speed and task shift by the Trail Making Tests (TMT, response inhibition by the Stroop Colour-Word Test (SCWT, working memory by the Digit Span Backwards (DSB test, immediate and delayed verbal recall by the Rey Auditory Verbal Learning Test (RAVLT and visuospatial recall by the Brief Visuospatial Memory Test (BVST. Results: One hundred and fifteen adults (69.5 years, SD6.4 completed baseline and delayed baseline (3 weeks apart before being randomised to either dance (n=60 or walking (n=55. Of those randomized, 79 (68% completed the follow-up measurements (32 weeks from baseline. In the dance group only, ‘non-completers’ had significant lower baseline scores on all executive function tests than those completed the full program. Intention-to-treat analyses showed no group effect. In a random effects model including participants who completed all measurements, adjusted for baseline score and covariates (age, education, estimated verbal intelligence, community, a between group effect in favour of dance was noted only for BVST total learning (Cohen’s D Effect size

  7. Impact of an integrated intervention program on atorvastatin adherence: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Goswami NJ

    2013-07-01

    Full Text Available Nilesh J Goswami,1 Mitch DeKoven,2 Andreas Kuznik,3 Jack Mardekian,3 Michelle R Krukas,2 Larry Z Liu,3,4 Patrick Bailey,1 Cynthia Deitrick,5 John Vincent3 1Prairie Heart Cardiovascular Consultants, Springfield, IL, USA; 2Health Economics and Outcomes Research, IMS Health, Alexandria, VA, USA; 3Pfizer Inc, New York, NY, USA; 4Weill Cornell Medical College, Cornell University, New York, NY, USA; 5Prairie Heart Education and Research Cooperative, Springfield, IL, USA Background: This trial evaluated the effectiveness of an integrated intervention program that included a 3-to-5-minute nurse counseling session, copay relief cards, and a monthly newsletter on adherence to atorvastatin treatment. Methods and results: A prospective, integrated (composed of nurse counseling, adherence tip sheet, copay relief card, opportunity to enroll in 12-week cholesterol management program randomized interventional study was designed involving patients >21 years of age who were prescribed atorvastatin at a large single-specialty cardiovascular physician practice in Illinois from March 2010 to May 2011. Data from the practice's electronic medical record were matched/merged to IMS Health's longitudinal data. A total of 500 patients were enrolled (125 in the control arm; 375 in the intervention arm. After data linkage, 53 control patients and 155 intervention patients were included in the analysis. Results: Mean age was 67.8 years (control and 69.5 years (intervention; 67.9% and 58.7%, respectively, were male. The mean 6-month adherence rate was 0.82 in both arms. The mean proportion of days covered for both the new-user control and intervention groups was the same, averaging 0.70 day (standard deviation [SD], 0.27 day; for continuing users, the proportion of days covered for the control group was 0.83 (SD, 0.24 and for the intervention group was 0.84 (SD, 0.22. For continuing users, the control group had mean persistent days of 151.6 (SD, 50.2 compared with 150.9 days

  8. Prayer and healing: A medical and scientific perspective on randomized controlled trials

    OpenAIRE

    Andrade, Chittaranjan; Radhakrishnan, Rajiv

    2009-01-01

    Religious traditions across the world display beliefs in healing through prayer. The healing powers of prayer have been examined in triple-blind, randomized controlled trials. We illustrate randomized controlled trials on prayer and healing, with one study in each of different categories of outcome. We provide a critical analysis of the scientific and philosophical dimensions of such research. Prayer has been reported to improve outcomes in human as well as nonhuman species, to have no effect...

  9. Platelet-rich fibrin versus albumin in surgical wound repair: a randomized trial with paired design

    DEFF Research Database (Denmark)

    Danielsen, Patricia L; Ågren, Sven Per Magnus; Jørgensen, Lars Nannestad

    2010-01-01

    To study the effects of autologous platelet-rich fibrin (PRF) versus human albumin on incisional wound breaking strength and subcutaneous collagen deposition in patients undergoing laparoscopic cholecystectomy in a randomized trial.......To study the effects of autologous platelet-rich fibrin (PRF) versus human albumin on incisional wound breaking strength and subcutaneous collagen deposition in patients undergoing laparoscopic cholecystectomy in a randomized trial....

  10. Systematic review: The relation between nutrition and nosocomial pneumonia: randomized trials in critically ill patients

    OpenAIRE

    Cook, Deborah; de Jonghe, Bernard; Heyland, Daren

    1997-01-01

    Objective To review the effect of enteral nutrition on nosocomial pneumonia in critically ill patients as summarized in randomized clinical trials. Study identification and selection Studies were identified through MEDLINE, SCISEARCH, EMBASE, the Cochrane Library, bibliographies of primary and review articles, and personal files. Through duplicate independent review, we selected randomized trials evaluating approaches to nutrition and their relation to nosocomial pneumonia. Data abstraction I...

  11. Randomized controlled trial of artesunate or artemether in Vietnamese adults with severe falciparum malaria

    OpenAIRE

    White Nicholas J; Chuong Ly V; Sinh Dinh X; Chau Tran TH; Mai Nguyen TH; Day Nicholas; Tuan Phung Q; Phu Nguyen H; Farrar Jeremy; Hien Tran T

    2010-01-01

    Abstract Background Both artemether and artesunate have been shown to be superior to quinine for the treatment of severe falciparum malaria in Southeast Asian adults, although the magnitude of the superiority has been greater for artesunate than artemether. These two artemisinin derivatives had not been compared in a randomized trial. Methods A randomized double blind trial in 370 adults with severe falciparum malaria; 186 received intramuscular artesunate (2.4 mg/kg immediately followed by 1...

  12. A randomized clinical trial evaluating the success rate of ethanol wet bonding technique and two adhesives

    OpenAIRE

    Vajihesadat Mortazavi; Pouran Samimi; Mojgan Rafizadeh; Shantia Kazemi

    2012-01-01

    Background : Composite resin restorations may have a short lifespan due to the degradation of resin-dentin interface. Ethanol wet bonding technique may extend the longevity of resin-dentin bond. The purpose of this one year randomized clinical trial was to compare clinical performance of two adhesives with ethanol wet bonding technique. Materials and Methods: This randomized clinical trial was performed on 36 non-carious cervical lesions in 12 patients restored with composite resin using ...

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

    OpenAIRE

    Luke Perraton; Zuzana Machotka; Saravana Kumar

    2009-01-01

    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. Onl...

  14. Computer-Aided Diabetes Education: A Synthesis of Randomized Controlled Trials

    OpenAIRE

    Boren, Suzanne Austin; Gunlock, Teira L.; Krishna, Santosh; Kramer, Teresa C.

    2006-01-01

    Computer-aided diabetes education is the application of technology to provide information on diabetes self-management as well as test the users’ knowledge and provide feedback. The objective of this paper was to evaluate the impact of computer-aided diabetes education in improving health outcomes. We identified reports of randomized controlled trials through systematic electronic database searches. Three eligibility criteria were applied: randomized controlled trial; evaluation of a computeri...

  15. Multilevel Analysis Methods for Partially Nested Cluster Randomized Trials

    Science.gov (United States)

    Sanders, Elizabeth A.

    2011-01-01

    This paper explores multilevel modeling approaches for 2-group randomized experiments in which a treatment condition involving clusters of individuals is compared to a control condition involving only ungrouped individuals, otherwise known as partially nested cluster randomized designs (PNCRTs). Strategies for comparing groups from a PNCRT in the…

  16. EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

    Science.gov (United States)

    Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

    2013-01-01

    Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

  17. Acupuncture for treating polycystic ovary syndrome: guidance for future randomized controlled trials*

    OpenAIRE

    Wu, Yan; Robinson, Nicola; Hardiman, Paul J.; Taw, Malcolm B.; Zhou, Jue; Wang, Fang-Fang; Qu, Fan

    2016-01-01

    Objective: To provide guidance for future randomized controlled trials (RCTs) based on a review concerning acupuncture for treating polycystic ovary syndrome (PCOS). Methods: A comprehensive literature search was conducted in October 2015 using MEDLINE, EMBASE, SCISEARCH, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Menstrual Disorders and Subfertility Group trials register, Allied and Complementary Medicine (AMED), China National Knowledge Infrastructure (CNKI), and...

  18. Survey and Practice of Reporting Quality of Randomized Controlled Clinical Trials on Traditional Chinese Medicine

    Institute of Scientific and Technical Information of China (English)

    LI Ting-qian; MAO Bing; WANG Gang; CHANG Jing; WANG Lei

    2008-01-01

    @@ Evidence obtained from randomized controlled trials (RCTs) has been generally accepted as the gold standard in the evaluation of clinical effectiveness. Readers need to understand the trial design, implementation, results, analysis and interpretation, so as to fully understand the results of RCTs. Thus, the investigators of RCTs have to report these items in a complete, accurate and clear manner.

  19. Randomized controlled trial of the CGRP receptor antagonist telcagepant for migraine prevention

    DEFF Research Database (Denmark)

    Ho, Tony W; Connor, Kathryn M; Zhang, Ying;

    2014-01-01

    OBJECTIVE: To evaluate whether the calcitonin gene-related peptide (CGRP) receptor antagonist telcagepant might be effective for migraine prevention. METHODS: In this randomized, double-blind, placebo-controlled, multicenter trial (ClinicalTrials.gov NCT00797667), patients experiencing 3-14 migra...

  20. Observer bias in randomized clinical trials with time-to-event outcomes

    DEFF Research Database (Denmark)

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

    2014-01-01

    BACKGROUND: We wanted to evaluate the impact of nonblinded outcome assessors on estimated treatment effects in time-to-event trials. METHODS: Systematic review of randomized clinical trials with both blinded and nonblinded assessors of the same time-to-event outcome. Two authors agreed on inclusion...

  1. A brief history of the randomized controlled trial. From oranges and lemons to the gold standard.

    Science.gov (United States)

    Meldrum, M L

    2000-08-01

    This article discusses the history and development of randomized clinical trial methodology, the reasons for its status and authority as a method of therapeutic evaluation, and the continuing role of clinical judgement in designing, interpreting, and applying the findings of trials. PMID:10949771

  2. Randomized Trial of Hyperfractionation Versus Conventional Fractionation in T2 Squamous Cell Carcinoma of the Vocal Cord (RTOG 9512)

    Energy Technology Data Exchange (ETDEWEB)

    Trotti, Andy, E-mail: andy.trotti@moffitt.org [Department of Radiation Oncology, University of South Florida H. Lee Moffittt Cancer Center, Tampa, Florida (United States); Zhang, Qiang [RTOG Statistical Center, Philadelphia, Pennsylvania (United States); Bentzen, Søren M. [Department of Human Oncology, University of Wisconsin School of Medicine, Madison, Wisconsin (United States); Emami, Bahman [Department of Radiation Therapy, Loyola University Medical Center, Maywood, Illinois (United States); Hammond, M. Elizabeth [Department of Pathology, LDS Hospital, Salt Lake City, Utah (United States); Jones, Christopher U. [Radiological Associates of Sacramento, Sacramento, California (United States); Morrison, William H. [University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Sagar, Stephen M. [McMaster University, Juravinski Cancer Centre, Hamilton, Ontario (Canada); Ridge, John A. [Department of Surgical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania (United States); Fu, Karen K. [Department of Radiation Oncology, University of California (emeritus), San Francisco, California (United States); Ang, K. Kian [Department of Radiotherapy, University of Texas MD Anderson Cancer Center, Houston, Texas (United States)

    2014-08-01

    Purpose: To compare hyperfractionation versus standard fractionation for T2N0 vocal cord carcinoma in a randomized controlled trial. Methods and Materials: Patients with T2 vocal cord cancer were stratified by substage (T2a vs T2b) and randomly assigned to receive either hyperfractionation (HFX) to 79.2 Gy in 66 fractions of 1.2 Gy given twice a day, or standard fractionation (SFX) to 70 Gy in 35 fractions given once a day. The trial was designed to detect a 55% reduction in the local failure hazard rate with 80% statistical power. Results: Between April 1996 and July 2003, a total of 250 patients were enrolled. Of 239 patients analyzable for outcomes, 94% were male, 83% had a Karnofsky performance status of 90-100, and 62% had T2a tumor. Median follow-up for all surviving patients was 7.9 years (range, 0.6-13.1 years). The 5-year local control (LC) rate was 8 points higher but not statistically significant (P=.14 for HFX [78%] vs SFX [70%]), corresponding to a 30% hazard rate reduction. The 5-year disease-free survival (DFS) was 49% versus 40% (P=.13) and overall survival (OS) was 72% versus 63% (P=.29). HFX was associated with higher rates of acute skin, mucosal, and laryngeal toxicity. Grade 3-4 late effects were similar with a 5-year cumulative incidence of 8.5% (3.4%-13.6%) after SFX and 8.5% (3.4%-13.5%) after HFX. Conclusions: The 5-year local control was modestly higher with HFX compared to SFX for T2 glottic carcinoma, but the difference was not statistically significant. These results are consistent with prior studies of hyperfractionation showing a benefit in local control. Substaging by T2a versus T2b carries prognostic value for DFS and OS. For cost and convenience reasons other altered fractionation schedules have been adopted in routine practice.

  3. New drugs with novel therapeutic characteristics. Have they been subject to randomized controlled trials?

    OpenAIRE

    Lexchin, Joel

    2002-01-01

    OBJECTIVE: To determine how many randomized controlled trials on the safety or efficacy of new drugs are published when these drugs are first marketed in Canada, and to determine the quality of the information in those trials. DESIGN: A MEDLINE search was conducted on each drug identified as having novel therapeutic characteristics and first marketed between 1990 and 2000. MAIN OUTCOME MEASURES: Number of trials dealing with the safety or efficacy of each drug published at the time the drug w...

  4. Effectiveness of papain gel in venous ulcer treatment: randomized clinical trial1

    OpenAIRE

    Ana Luiza Soares Rodrigues; Beatriz Guitton Renaud Baptista de Oliveira; Débora Omena Futuro; Silvia Regina Secoli

    2015-01-01

    OBJECTIVE: to assess the effectiveness of 2% papain gel compared to 2% carboxymethyl cellulose in the treatment of chronic venous ulcer patients. METHOD: randomized controlled clinical trial with 12-week follow-up. The sample consisted of 18 volunteers and 28 venous ulcers. In the trial group, 2% papain gel was used and, in the control group, 2% carboxymethyl cellulose gel. RESULTS: the trial group showed a significant reduction in the lesion area, especially between the fifth and twelfth wee...

  5. Protocol for the Osteoporosis Choice trial. A pilot randomized trial of a decision aid in primary care practice

    Directory of Open Access Journals (Sweden)

    Tulledge-Scheitel Sidna M

    2009-12-01

    Full Text Available Abstract Background Bisphosphonates can reduce fracture risk in patients with osteoporosis, but many at-risk patients do not start or adhere to these medications. The aims of this study are to: (1 preliminarily evaluate the effect of an individualized 10-year osteoporotic fracture risk calculator and decision aid (OSTEOPOROSIS CHOICE for postmenopausal women at risk for osteoporotic fractures; and (2 assess the feasibility and validity (i.e., absence of contamination of patient-level randomization (vs. cluster randomization in pilot trials of decision aid efficacy. Methods/Design This is a protocol for a parallel, 2-arm, randomized trial to compare an intervention group receiving OSTEOPOROSIS CHOICE to a control group receiving usual primary care. Postmenopausal women with bone mineral density T-scores of STEOPOROSIS CHOICE on five outcomes: (a patient knowledge regarding osteoporosis risk factors and treatment; (b quality of the decision-making process for both the patient and clinician; (c patient and clinician acceptability and satisfaction with the decision aid; (d rate of bisphosphonate use and adherence, and (e trial processes (e.g., ability to recruit participants, collect patient outcomes. To capture these outcomes, we will use patient and clinician surveys following each visit and video recordings of the clinical encounters. These video recordings will also allow us to determine the extent to which clinicians previously exposed to the decision aid were able to recreate elements of the decision aid with control patients (i.e., contamination. Pharmacy prescription profiles and follow-up phone interviews will assess medication start and adherence at 6 months. Discussion This pilot trial will provide evidence of feasibility, validity of patient randomization, and preliminary efficacy of a novel approach -- decision aids -- to improving medication adherence for postmenopausal women at risk of osteoporotic fractures. The results will inform

  6. Validating intramyocardial bone marrow stem cell therapy in combination with coronary artery bypass grafting, the PERFECT Phase III randomized multicenter trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Donndorf Peter

    2012-07-01

    Full Text Available Abstract Background For the last decade continuous efforts have been made to translate regenerative cell therapy protocols in the cardiovascular field from ‘bench to bedside’. Successful clinical introduction, supporting safety, and feasibility of this new therapeutic approach, led to the initiation of the German, Phase III, multicenter trial - termed the PERFECT trial (ClinicalTrials.gov Identifier: NCT00950274, in order to evaluate the efficacy of surgical cardiac cell therapy on left ventricular function. Methods/Design The PERFECT trial has been designed as a prospective, randomized, double-blind, placebo controlled, multicenter trial, analyzing the effect of intramyocardial CD 133+ bone marrow stem cell injection in combination with coronary artery bypass grafting on postoperative left ventricular function. The trial includes patients aged between 18 and 79 years presenting with a coronary disease with indication for surgical revascularization and reduced global left ventricular ejection fraction as assessed by cardiac magnet resonance imaging. The included patients are treated in the chronic phase of ischemic cardiomyopathy after previous myocardial infarction. Discussion Patients undergoing coronary artery bypass grafting in combination with intramyocardial CD133+ cell injection will have a higher LV ejection fraction than patient who undergo CABG alone, measured 6 months after the operation. Trial registration ClinicalTrials.gov Identifier: NCT00950274

  7. Randomized controlled trials in relapsed/refractory follicular lymphoma: a systematic review and meta-analysis.

    Science.gov (United States)

    Police, Rachel L; Trask, Peter C; Wang, Jianmin; Olivares, Robert; Khan, Shahnaz; Abbe, Adeline; Colosia, Ann; Njue, Annete; Sherril, Beth; Ruiz-Soto, Rodrigo; Kaye, James A; Hamadani, Mehdi

    2016-10-01

    This systematic literature review evaluated the clinical efficacy and safety of interventions used in relapsed/refractory follicular lymphoma. Primary efficacy outcomes were objective response rate, progression-free survival and overall survival. Safety endpoints were grade 3/4 toxicities, serious adverse events and withdrawals or deaths due to toxicity. Studies were selected if they were randomized controlled trials reporting on the efficacy or safety of treatments for relapsed or refractory follicular lymphoma, and if outcomes were reported separately from trials that included other lymphoid neoplasms. We used the Bucher method for conducting adjusted indirect comparisons within a meta-analysis. We identified 10 randomized controlled trials of treatments for relapsed/refractory follicular lymphoma. The most prominent drug investigated (alone or in combination) was rituximab. Most trials did not report median overall survival. Two trials reported median event-free survival (range, 1.2-23.2 months). Six of ten trials reported objective response rate (range, 9-93%). Meta-analysis showed only one statistically significant result: rituximab + bortezomib yielded a significantly higher objective response rate than rituximab monotherapy (relative risk, 1.28; 95% confidence interval, 1.11-1.47). Otherwise, there were no discernable differences in overall survival or progression-free survival, partly due to insufficient reporting of results in the clinical trials. The relatively small number of randomized controlled trials, few overlapping treatment arms, and variability in the randomized controlled trial features and in the endpoints studied complicate the formal comparison of therapies for relapsed/refractory follicular lymphoma. Additional well-designed randomized controlled trials are needed to fully understand the relative outcomes of older and more recently developed therapies. PMID:26320127

  8. The Sonoma Water Evaluation Trial (SWET): A randomized drinking water intervention trial to reduce gastrointestinal illness in older adults

    Science.gov (United States)

    Objectives. We estimate the risk of highly credible gastrointestinal illness (HCGI) among adults 55 and older in a community drinking tap water meeting current U.S. standards. Methods. We conducted a randomized, triple-blinded, crossover trial in 714 households (988 indiv...

  9. Randomized Controlled Trial of a Preventive Intervention for Perinatal Depression in High-Risk Latinas

    Science.gov (United States)

    Le, Huynh-Nhu; Perry, Deborah F.; Stuart, Elizabeth A.

    2011-01-01

    Objective: A randomized controlled trial was conducted to evaluate the efficacy of a cognitive-behavioral (CBT) intervention to prevent perinatal depression in high-risk Latinas. Method: A sample of 217 participants, predominantly low-income Central American immigrants who met demographic and depression risk criteria, were randomized into usual…

  10. Efficacy of the "Responsive Classroom" Approach: Results from a 3-Year, Longitudinal Randomized Controlled Trial

    Science.gov (United States)

    Rimm-Kaufman, Sara E.; Larsen, Ross A. A.; Baroody, Alison E.; Curby, Timothy W.; Ko, Michelle; Thomas, Julia B.; Merritt, Eileen G.; Abry, Tashia; DeCoster, Jamie

    2014-01-01

    This randomized controlled field trial examined the efficacy of the Responsive Classroom (RC) approach on student achievement. Schools (n = 24) were randomized into intervention and control conditions; 2,904 children were studied from end of second to fifth grade. Students at schools assigned to the RC condition did not outperform students at…

  11. Intention-to-Treat Analysis in Partially Nested Randomized Controlled Trials with Real-World Complexity

    Science.gov (United States)

    Schweig, Jonathan David; Pane, John F.

    2016-01-01

    Demands for scientific knowledge of what works in educational policy and practice has driven interest in quantitative investigations of educational outcomes, and randomized controlled trials (RCTs) have proliferated under these conditions. In educational settings, even when individuals are randomized, both experimental and control students are…

  12. Understanding Statistical Power in Cluster Randomized Trials: Challenges Posed by Differences in Notation and Terminology

    Science.gov (United States)

    Spybrook, Jessaca; Hedges, Larry; Borenstein, Michael

    2014-01-01

    Research designs in which clusters are the unit of randomization are quite common in the social sciences. Given the multilevel nature of these studies, the power analyses for these studies are more complex than in a simple individually randomized trial. Tools are now available to help researchers conduct power analyses for cluster randomized…

  13. A Data Management System Integrating Web-Based Training and Randomized Trials

    Science.gov (United States)

    Muroff, Jordana; Amodeo, Maryann; Larson, Mary Jo; Carey, Margaret; Loftin, Ralph D.

    2011-01-01

    This article describes a data management system (DMS) developed to support a large-scale randomized study of an innovative web-course that was designed to improve substance abuse counselors' knowledge and skills in applying a substance abuse treatment method (i.e., cognitive behavioral therapy; CBT). The randomized trial compared the performance…

  14. Randomized clinical trial of single- versus multi-incision laparoscopic cholecystectomy

    DEFF Research Database (Denmark)

    Jørgensen, Lars Nannestad; Rosenberg, J; Al-Tayar, H;

    2014-01-01

    BACKGROUND: There are no randomized studies that compare outcomes after single-incision (SLC) and conventional multi-incision (MLC) laparoscopic cholecystectomy under an optimized perioperative analgesic regimen. METHODS: This patient- and assessor-blinded randomized three-centre clinical trial...

  15. Randomized clinical trial of symptom control after stapled anopexy or diathermy excision for haemorrhoid prolapse

    DEFF Research Database (Denmark)

    Nyström, P-O; Qvist, N; Raahave, D;

    2010-01-01

    BACKGROUND: : This multicentre randomized clinical trial studied how symptoms improved after either stapled anopexy or diathermy excision of haemorrhoids. METHODS: : The study involved 18 hospitals in Sweden, Denmark and the UK. Some 207 patients were randomized to either anopexy or Milligan-Morg...

  16. A Parent-Adolescent Intervention to Increase Sexual Risk Communication: Results of a Randomized Controlled Trial

    Science.gov (United States)

    Villarruel, Antonia M.; Cherry, Carol Loveland; Cabriales, Esther Gallegos; Ronis, David L.; Zhou, Yan

    2008-01-01

    This article reports results of a randomized controlled trial designed to test an intervention to increase parent-adolescent sexual risk communication among Mexican parents. Data were analyzed from parents (n = 791) randomly assigned to an HIV risk reduction or health promotion intervention. Measures were administered at pretest, posttest, and 6-…

  17. Effect of Art Production on Negative Mood: A Randomized, Controlled Trial

    Science.gov (United States)

    Bell, Chloe E.; Robbins, Steven J.

    2007-01-01

    Art therapists have long held that art production causes reductions in stress and elevations in mood (Rubin, 1999). The authors examined this claim in a randomized, controlled trial. Fifty adults between the ages of 18 and 30 were randomly assigned to either create an art work or to view and sort a series of art prints. Three measures of overall…

  18. The Efficacy of Parent-Child Interaction Therapy with Chinese Families: Randomized Controlled Trial

    Science.gov (United States)

    Leung, Cynthia; Tsang, Sandra; Sin, Tammy C. S.; Choi, Siu-yan

    2015-01-01

    Objective: This study aimed to examine the efficacy of the Parent-Child Interaction Therapy (PCIT) in Hong Kong Chinese families, using randomized controlled trial design. Methods: The participants included 111 Hong Kong Chinese parents with children aged 2--7 years old, who were randomized into the intervention group (n = 54) and control group (n…

  19. Outcomes from a School-Randomized Controlled Trial of Steps to Respect: A Bullying Prevention Program

    Science.gov (United States)

    Brown, Eric C.; Low, Sabina; Smith, Brian H.; Haggerty, Kevin P.

    2011-01-01

    This study reports the outcomes of a randomized controlled trial of Steps to Respect: A Bullying Prevention Program conducted in 33 California elementary schools. Schools were matched on school demographic characteristics and assigned randomly to intervention or waitlisted control conditions. Outcome measures were obtained from (a) all school…

  20. Maternal Dietary Counseling Reduces Consumption of Energy-Dense Foods among Infants: A Randomized Controlled Trial

    Science.gov (United States)

    Vitolo, Marcia Regina; Bortolini, Gisele Ane; Campagnolo, Paula Dal Bo; Hoffman, Daniel J.

    2012-01-01

    Objective: To evaluate the impact of a dietary counseling in reducing the intake of energy-dense foods by infants. Design: A randomized controlled trial. Setting and Participants: Sao Leopoldo, Brazil. Mothers and infants of a low-income-group population were randomized into intervention (n = 163) and received dietary counseling during 10 home…

  1. A Randomized Controlled Trial of a Standardized Behavior Management Intervention for Students with Externalizing Behavior

    Science.gov (United States)

    Forster, Martin; Sundell, Knut; Morris, Richard J.; Karlberg, Martin; Melin, Lennart

    2012-01-01

    This study reports the results from a Swedish randomized controlled trial of a standardized behavior management intervention. The intervention targeted students with externalizing behavior in a regular education setting. First- and second-grade students (N = 100) from 38 schools were randomly assigned to either the intervention or an active…

  2. Effects of Check and Connect on Attendance, Behavior, and Academics: A Randomized Effectiveness Trial

    Science.gov (United States)

    Maynard, Brandy R.; Kjellstrand, Elizabeth K.; Thompson, Aaron M.

    2014-01-01

    Objectives: This study examined the effects of Check & Connect (C&C) on the attendance, behavior, and academic outcomes of at-risk youth in a field-based effectiveness trial. Method: A multisite randomized block design was used, wherein 260 primarily Hispanic (89%) and economically disadvantaged (74%) students were randomized to treatment…

  3. Acute migraine therapy: recent evidence from randomized comparative trials

    DEFF Research Database (Denmark)

    Mett, A.; Tfelt-Hansen, P.

    2008-01-01

    (1) A wide array of data regarding acute migraine treatment are available, but few trials strictly adhere to International Headache Society guidelines for patient inclusion criteria. (2) Triptans appear to have similar efficacy profiles, but among newer triptans, almotriptan offers improved toler...

  4. Beyond Randomized Controlled Trials in Attempted Suicide Research

    Science.gov (United States)

    Hatcher, Simon; Sharon, Cynthia; Coggan, Carol

    2009-01-01

    There is a lack of evidence about what is the best treatment for people who present to hospital after self harm. Most treatment trials have been small and involved unrepresentative groups of patients which result in inconclusive findings. Here we note some of the characteristics of attempted suicide which make it a difficult subject to study. We…

  5. Sublingual immunotherapy in youngsters : adherence in a randomized clinical trial

    NARCIS (Netherlands)

    Roder, E.; Berger, M. Y.; de Groot, H.; van Wijk, R. Gerth

    2008-01-01

    Background Adherence is essential for effective treatment. Although several trials on the efficacy of sublingual immunotherapy (SLIT) in youngsters have been published, few contain data on medication intake. Objective We aimed to quantify adherence both to study protocol and medication intake as wel

  6. Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial

    DEFF Research Database (Denmark)

    Kappos, Ludwig; Freedman, Mark S; Polman, Chris H;

    2009-01-01

    beta-1b 250 microg (n=292; early treatment) or placebo (n=176; delayed treatment) subcutaneously every other day for 2 years, or until diagnosis of CDMS. All patients were then eligible to enter a prospectively planned follow-up phase with open-label interferon beta-1b up to a maximum of 5 years after...

  7. Electrocardiographic changes associated with smoking and smoking cessation: outcomes from a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Adam D Gepner

    Full Text Available INTRODUCTION: Cardiovascular disease (CVD can be detected and quantified by analysis of the electrocardiogram (ECG; however the effects of smoking and smoking cessation on the ECG have not been characterized. METHODS: Standard 12-lead ECGs were performed at baseline and 3 years after subjects enrolled in a prospective, randomized, placebo-controlled clinical trial of smoking cessation pharmacotherapies. ECGs were interpreted using the Minnesota Code ECG Classification. The effects of (i smoking burden on the prevalence of ECG findings at baseline, and (ii smoking and smoking cessation on ECG changes after 3 years were investigated by multivariable and multinomial regression analyses. RESULTS: At baseline, 532 smokers were (mean [SD] 43.3 (11.5 years old, smoked 20.6 (7.9 cigarettes/day, with a smoking burden of 26.7 (18.6 pack-years. Major and minor ECG criteria were identified in 87 (16.4% and 131 (24.6% of subjects, respectively. After adjusting for demographic data and known CVD risk factors, higher pack-years was associated with major ECG abnormalities (p = 0.02, but current cigarettes/day (p = 0.23 was not. After 3 years, 42.9% of subjects were abstinent from smoking. New major and minor ECG criteria were observed in 7.2% and 15.6% of subjects respectively, but in similar numbers of abstinent subjects and continuing smokers (p>0.2 for both. Continuing smokers showed significant reduction in current smoking (-8.4 [8.8] cigarettes/day, p<0.001 compared to baseline. CONCLUSIONS: In conclusion, major ECG abnormalities are independently associated with lifetime smoking burden. After 3 years, smoking cessation was not associated with a decrease in ECG abnormalities, although cigarettes smoked/day decreased among continuing smokers.

  8. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial.

    NARCIS (Netherlands)

    Stupp, R.; Hegi, M.E.; Mason, W.P.; Bent, M.J. van den; Taphoorn, M.J.B.; Janzer, R.C.; Ludwin, S.K.; Allgeier, A.; Fisher, B.; Belanger, K.; Hau, P.; Brandes, A.A.; Gijtenbeek, J.M.M.; Marosi, C.; Vecht, C.J.; Mokhtari, K.; Wesseling, P.; Villa, S.; Eisenhauer, E.; Gorlia, T.; Weller, M.; Lacombe, D.; Cairncross, J.G.; Mirimanoff, R.O.

    2009-01-01

    BACKGROUND: In 2004, a randomised phase III trial by the European Organisation for Research and Treatment of Cancer (EORTC) and National Cancer Institute of Canada Clinical Trials Group (NCIC) reported improved median and 2-year survival for patients with glioblastoma treated with concomitant and ad

  9. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study : 5-year analysis of the EORTC-NCIC trial

    NARCIS (Netherlands)

    Stupp, Roger; Hegi, Monika E.; Mason, Warren P.; van den Bent, Martin J.; Taphoorn, Martin J. B.; Janzer, Robert C.; Ludwin, Samuel K.; Allgeier, Anouk; Fisher, Barbara; Belanger, Karl; Hau, Peter; Brandes, Alba A.; Gijtenbeek, Johanna; Marosi, Christine; Vecht, Charles J.; Mokhtari, Karima; Wesseling, Pieter; Villa, Salvador; Eisenhauer, Elizabeth; Gorlia, Thierry; Weller, Michael; Lacombe, Denis; Cairncross, J. Gregory; Mirimanoff, Rene-Olivier

    2009-01-01

    Background In 2004, a randomised phase III trial by the European Organisation for Research and Treatment of Cancer (EORTC) and National Cancer Institute of Canada Clinical Trials Group (NCIC) reported improved median and 2-year survival for patients with glioblastoma treated with concomitant and adj

  10. The B-VITAGE trial: A randomized trial of homocysteine lowering treatment of depression in later life

    Directory of Open Access Journals (Sweden)

    van Bockxmeer Frank

    2010-01-01

    Full Text Available Abstract Background Depression is a leading cause of disability worldwide and depressive symptoms are common in later life. Observational evidence suggests that depression is more prevalent among people with high plasma homocysteine (tHcy, but the results of randomized trials to date have been unable to show that lowering tHcy through the supplementation of vitamins B6, B12 and folate benefits depressive symptoms. We designed the B-VITAGE trial to determine whether adjunctive treatment with vitamins B6, B12 and folate increases the efficacy of standard antidepressant treatment. Methods/Design The B-VITAGE trial is a 12-month randomized, double-blind, placebo-controlled trial of daily citalopram (20 to 40 mg plus B12(0.4 mg, B6 (25 mg and folic acid (2 mg or citalopram (20 to 40 mg plus placebo for the treatment of depression in later life. The trial aims to recruit over 300 older adults with major depression (DSM-IV and has been powered to detect the impact of an intervention associated with moderate effect size. Depressive symptoms will be rated with the Montgomery-Åsberg Depression Rating Scale (MADRS. The trial has two main outcomes of interest: a reduction of 50% or more in the MADRS total score between baseline and week 12 and the remission of the depressive episode at weeks 12, 26 and 52 according to DSM-IV criteria. We hypothesize that subjects randomly allocated to the vitamin arm of the study will be more likely to show a clinically significant improvement and achieve and maintain remission of symptoms at 12, 26 and 52 weeks. Secondary outcomes of interest include compliance with treatment, reduction in the severity of depressive symptoms, switching to different antidepressants, the use of non-pharmacological antidepressant treatments, response to treatment according to MTHFRC677T genotype, and changes in cognitive function over 52 weeks. Conclusions The results of this trial will clarify whether the systematic use of B

  11. Blinding Techniques in Randomized Controlled Trials of Laser Therapy: An Overview and Possible Solution

    Directory of Open Access Journals (Sweden)

    Ian Relf

    2008-01-01

    Full Text Available Low-level laser therapy has evidence accumulating about its effectiveness in a variety of medical conditions. We reviewed 51 double blind randomized controlled trials (RCTs of laser treatment. Analysis revealed 58% of trials showed benefit of laser over placebo. However, less than 5% of the trials had addressed beam disguise or allocation concealment in the laser machines used. Many of the trials used blinding methods that rely on staff cooperation and are therefore open to interference or bias. This indicates significant deficiencies in laser trial methodology. We report the development and preliminary testing of a novel laser machine that can blind both patient and operator to treatment allocation without staff participation. The new laser machine combines sealed preset and non-bypassable randomization codes, decoy lights and sound, and a conical perspex tip to overcome laser diode glow detection.

  12. Effects of Vitamin D Intake on FEV1 and COPD Exacerbation: A Randomized Clinical Trial Study

    OpenAIRE

    2015-01-01

    Aim: This study aimed to evaluate the effects of vitamin D intake on COPD exacerbation and FEV1 in the patients with severe and very severe COPD. Methods: This double blind placebo control randomized clinical trial study was done in the Ashayer university hospital in Khorramabad in 2012. Eighty eight patients with severe and very severe COPD were randomly selected from those who recoursed to the internal medicine clinic of Ashayer hospital. They were randomly allocated to case and placebo gro...

  13. Effects of zinc supplementation on subscales of anorexia in children: A randomized controlled trial

    OpenAIRE

    Khademian, Majid; Farhangpajouh, Neda; Shahsanaee, Armindokht; Bahreynian, Maryam; Mirshamsi, Mehran; Roya KELISHADI

    2014-01-01

    Objectives: This study aims to assess the effects of zinc supplementation on improving the appetite and its subscales in children. Methods: This study was conducted in 2013 in Isfahan, Iran. It had two phases. At the first step, after validation of the Child Eating Behaviour Questionaire (CEBQ), it was completed for 300 preschool children, who were randomly selected. The second phase was conducted as a randomized controlled trial. Eighty of these children were randomly selected, and were rand...

  14. Acupuncture as a treatment for functional dyspepsia: design and methods of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Yan Jie

    2009-08-01

    Full Text Available Abstract Background Acupuncture is widely used in China to treat functional dyspepsia (FD. However, its effectiveness in the treatment of FD, and whether FD-specific acupoints exist, are controversial. So this study aims to determine if acupuncture is an effective treatment for FD and if acupoint specificity exists according to traditional acupuncture meridians and acupoint theories. Design This multicenter randomized controlled trial will include four acupoint treatment groups, one non-acupoint control group and one drug (positive control group. The four acupoint treatment groups will focus on: (1 specific acupoints of the stomach meridian; (2 non-specific acupoints of the stomach meridian; (3 specific acupoints of alarm and transport points; and (4 acupoints of the gallbladder meridian. These four groups of acupoints are thought to differ in terms of clinical efficacy, according to traditional acupuncture meridians and acupoint theories. A total of 120 FD patients will be included in each group. Each patient will receive 20 sessions of acupuncture treatment over 4 weeks. The trial will be conducted in eight hospitals located in three centers of China. The primary outcomes in this trial will include differences in Nepean Dyspepsia Index scores and differences in the Symptom Index of Dyspepsia before randomization, 2 weeks and 4 weeks after randomization, and 1 month and 3 months after completing treatment. Discussion The important features of this trial include the randomization procedures (controlled by a central randomization system, a standardized protocol of acupuncture manipulation, and the fact that this is the first multicenter randomized trial of FD and acupuncture to be performed in China. The results of this trial will determine whether acupuncture is an effective treatment for FD and whether using different acupoints or different meridians leads to differences in clinical efficacy. Trial registration number Clinical Trials

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

    Directory of Open Access Journals (Sweden)

    Yuri Alejandro Castro

    2014-03-01

    Full Text Available ABSTRACT 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 ± 1.03 mm. Another group (control of six patients was treated using connective grafts (mean age, 57.1 ± 2.7 years; mean recession 4.33 ± 1.03 mm. 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 ± 2.06 mm and 4.5 ± 0.83 mm 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 0.98 mm 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

  16. 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

    OpenAIRE

    Selby Peter; Brosky Gerald; Oh Paul I; Raymond Vincent; Ranger Suzanne

    2012-01-01

    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 realisti...

  17. Stability, Survival, and Tolerability of an Auditory Osseointegrated Implant for Bone Conduction Hearing: Long-Term Follow-Up of a Randomized Controlled Trial

    Science.gov (United States)

    den Besten, Christine A.; Stalfors, Joacim; Wigren, Stina; Blechert, Johan Ivarsson; Flynn, Mark; Eeg-Olofsson, Måns; Aggarwal, Rohini; Green, Kevin; Nelissen, Rik C.; Mylanus, Emmanuel A. M.; Hol, Myrthe K. S.

    2016-01-01

    Objective: To compare implant stability, survival, and soft tissue reactions for a novel (test) and previous generation (control) percutaneous auditory osseointegrated implant for bone conduction hearing at long-term follow-up of 5 years. Study Design: Single follow-up visit of a previously completed multicenter, randomized, controlled trial. Patients: Fifty-seven of the 77 participants of a completed randomized controlled trial on a new auditory osseointegrated implant underwent a single follow-up visit 5 years after implantation, which comprised implant stability measurements and collection of Holgers scores. Additionally, implant survival was recorded for all 77 patients from the original trial. Results: The test implant showed significantly higher implant stability quotient (ISQ) values compared with the control implant throughout the 5-year follow-up. Mean area under the curve of ISQ high from baseline to 5 years was 71.6 (standard deviation [SD] ±2.0) and 66.7 (SD ±3.4) for the test and control implant, respectively (p < 0.0001). For both implants, the mean ISQ value recorded at 5 years was higher compared with implantation (test group +2.03 [SD ±2.55, within group p < 0.0001] and control group +2.25 [SD ±4.95, within group p = 0.12]). No difference was noticed in increase from baseline between groups (p = 0.64). Furthermore, evaluation of soft tissue reactions continued to show superiority of the test implant. At the 5-year follow-up visit, one patient (2.5%) presented with a Holgers grade 2 in the test group, compared with four patients (23.5%) in the control group (p = 0.048); no patient presented with more severe soft tissue reactions. Excluding explantations, the survival rate was 95.8% for the test group and 95.0% for the control group. The corresponding rates including explantations were 93.9 and 90.0%. Conclusion: The test implant showed superiority in terms of higher mean ISQ values and less adverse soft tissue reactions, both

  18. A randomized phase II trial of concurrent chemo-RT of oral vinorelbine and 60 Gy or 66 Gy, in locally advanced NSCLC

    DEFF Research Database (Denmark)

    Hansen, O.; Knap, M.; Khalil, A.;

    2015-01-01

    Purpose/Objective: Concurrent chemo-radiation (CRT) is the treatment of choice for local advanced NSCLC patients. Despite the curative intent of the treatment, survival is poor with a median survival of about 16-18 months (m) and a 5 year (y) survival of 15%. The loco-regional control rate at 2 y...... is only about 30% in clinical trials. This randomized phase-II trial tested a dose intense oral vinorelbine (Nav) regimen with two doses of RT, 60 Gy/30 F (arm A) and 66 Gy/33 F (arm B). Materials and Methods: Before randomization to arm A or B, the patients were treated with 2 cycles of induction...

  19. Radonexposure with the treatment of rheumatic diseases - randomized controlled trials

    Energy Technology Data Exchange (ETDEWEB)

    Falkenbach, A. [Krankenanstalt Gasteiner Heilstollen, Bad Gastein-Boeckstein (Austria)]|[Forschungsinstitut Gastein, Bad Gastein (Austria); Kovac, J.; Brandmaier, P. [Krankenanstalt Gasteiner Heilstollen, Bad Gastein-Boeckstein (Austria); Soto, J. [Dept. of Medical Physics, Univ. of Cantabria (Spain)

    2001-07-01

    The objective was to investigate whether there is evidence for the effectiveness of radon therapy in the treatment of rheumatic diseases. Method: Medline and MedKur databases were searched for randomised controlled clinical trials. Radon therapy centres and experts in the field were contacted, proceedings were hand-searched and bibliographies were checked for references of potential impact. Four clinical trials evaluating the effect of radon in patients suffering from rheumatic diseases with no or only a small number of drop-outs met the inclusion criteria. In patients with degenerative disease of the spine and large joints, two trials [1,2] reported less pain on pressure of painful paraspinal muscle points after a series of radon baths at a concentration of 0.8 kBq/L and 3 kBq/L, respectively. The alleviation of pain was most pronounced in the weeks following the treatment period. [3]. At six months follow-up serial immersion in combined radon and CO{sub 2} baths reduced pain and functional restrictions in patients with rheumatoid arthritis (n=60) more effectively than bathing in CO{sub 2} only. [4] In 130 patients with ankylosing spondylitis a complex rehabilitation program at a health resort (group 1 and 2) showed greater and longer-lasting differences to a control group staying at home (group 3), if speleotherapeutic radon exposure (group 1) was added (as compared to an added sauna treatment, group 2). Conclusion: The four trials meeting the inclusion criteria showed beneficial effects of radon therapy compared to interventions without radon exposure. Up to nine months after the treatment period significantly better results were observed, if radon therapy is added. (orig.)

  20. Vitamin D and Serum Cytokines in a Randomized Clinical Trial

    OpenAIRE

    Eleanor Yusupov; Melissa Li-Ng; Simcha Pollack; James K. Yeh; Mageda Mikhail; Aloia, John F

    2010-01-01

    Background. The role of vitamin D in the body's ability to fight influenza and URI's may be dependent on regulation of specific cytokines that participate in the host inflammatory response. The aim of this study was to test the hypothesis that vitamin D can influence intracellular signaling to regulate the production of cytokines. Subjects and Methods. This study was a 3-month prospective placebo-controlled trial of vitamin D3 supplementation in ambulatory adults [Li-Ng et al., 2009]....

  1. The transitive fallacy for randomized trials: If A bests B and B bests C in separate trials, is A better than C?

    Directory of Open Access Journals (Sweden)

    Kramer Barnett S

    2002-11-01

    Full Text Available Abstract Background If intervention A bests B in one randomized trial, and B bests C in another randomized trial, can one conclude that A is better than C? The problem was motivated by the planning of a randomized trial, where A is spiral-CT screening, B is x-ray screening, and C is no screening. On its surface, this would appear to be a straightforward application of the transitive principle of logic. Methods We extended the graphical approach for omitted binary variables that was originally developed to illustrate Simpson's paradox, applying it to hypothetical, but plausible scenarios involving lung cancer screening, treatment for gastric cancer, and antibiotic therapy for clinical pneumonia. Results Graphical illustrations of the three examples show different ways the transitive fallacy for randomized trials can arise due to changes in an unobserved or unadjusted binary variable. In the most dramatic scenario, B bests C in the first trial, A bests B in the second trial, but C bests A at the time of the second trial. Conclusion Even with large sample sizes, combining results from a previous randomized trial of B versus C with results from a new randomized trial of A versus B will not guarantee correct inference about A versus C. A three-arm trial of A, B, and C would protect against this problem and should be considered when the sequential trials are performed in the context of changing secular trends in important omitted variables such as therapy in cancer screening trials.

  2. A critical appraisal of the evidence for using cardiotocography plus ECG ST interval analysis for fetal surveillance in labor. Part I: The randomized controlled trials

    OpenAIRE

    Olofsson, Per; Ayres-de-Campos, Diogo; Kessler, Jörg; Tendal, Britta; Yli, Branislava Markovic; Devoe, Lawrence

    2014-01-01

    We reappraised the five randomized controlled trials that compared cardiotocography plus ECG ST interval analysis (CTG+ST) vs. cardiotocography. The numbers enrolled ranged from 5681 (Dutch randomized controlled trial) to 799 (French randomized controlled trial). The Swedish randomized controlled trial (n = 5049) was the only trial adequately powered to show a difference in metabolic acidosis, and the Plymouth randomized controlled trial (n = 2434) was only powered to show a difference in ope...

  3. Long-term safety and efficacy of percutaneous coronary intervention with stenting and coronary artery bypass surgery for multivessel coronary artery disease: A meta-analysis with 5-year patient-level data from the ARTS, ERACI-II, MASS-II, and SoS trials

    NARCIS (Netherlands)

    J. Daemen (Joost); H. Boersma (Eric); M. Flather (Marcus); J. Booth (Jean); R.H. Stables (Rodney); A. Rodriguez (Alfredo Chapin); G.A. Rodriguez-Granillo (Gaston); W.A. Hueb (Whady Armindo); P.A. Lemos Neto (Pedro); P.W.J.C. Serruys (Patrick)

    2008-01-01

    textabstractBackground - Randomized trials that studied clinical outcomes after percutaneous coronary intervention (PCI) with bare metal stenting versus coronary artery bypass grafting (CABG) are underpowered to properly assess safety end points like death, stroke, and myocardial infarction. Pooling

  4. Randomized Controlled Trial on Physical Therapy for TMJ Closed Lock

    NARCIS (Netherlands)

    Craane, B.; Dijkstra, P. U.; Stappaerts, K.; De Laat, A.

    2012-01-01

    This study evaluated the one-year effect of physical therapy on pain and mandibular dysfunction associated with anterior disc displacement without reduction of the temporomandibular joint (closed lock). Forty-nine individuals were randomly assigned to either a physical therapy group [n = 23, mean ag

  5. A randomized trial of montelukast in respiratory syncytial virus postbronchiolitis

    DEFF Research Database (Denmark)

    Bisgaard, Hans

    2003-01-01

    subsequent to RSV bronchiolitis. One hundred and thirty infants who were 3 to 36 months old, hospitalized with acute RSV bronchiolitis, were randomized into a double-blind, parallel comparison of 5-mg montelukast chewable tablets or matching placebo given for 28 days starting within 7 days of symptom debut...

  6. Randomized, controlled trial of telcagepant over four migraine attacks

    DEFF Research Database (Denmark)

    Ho, Andrew P; Dahlöf, Carl Gh; Silberstein, Stephen D;

    2010-01-01

    This study evaluated the calcitonin gene-related peptide (CGRP) receptor antagonist telcagepant (tablet formulation) for treatment of a migraine attack and across four attacks. Adults with migraine were randomized, double-blind, to telcagepant 140 mg, telcagepant 280 mg, or control treatment sequ...

  7. Randomized Trial of Tocilizumab in Systemic Juvenile Idiopathic Arthritis

    NARCIS (Netherlands)

    De Benedetti, Fabrizio; Brunner, Hermine I.; Ruperto, Nicolino; Kenwright, Andrew; Wright, Stephen; Calvo, Inmaculada; Cuttica, Ruben; Ravelli, Angelo; Schneider, Rayfel; Woo, Patricia; Wouters, Carine; Xavier, Ricardo; Zemel, Lawrence; Baildam, Eileen; Burgos-Vargas, Ruben; Dolezalova, Pavla; Garay, Stella M.; Merino, Rosa; Joos, Rik; Grom, Alexei; Wulffraat, Nico; Zuber, Zbigniew; Zulian, Francesco; Lovell, Daniel; Martini, Alberto

    2012-01-01

    BACKGROUND Systemic juvenile idiopathic arthritis (JIA) is the most severe subtype of JIA; treatment options are limited. Interleukin-6 plays a pathogenic role in systemic JIA. METHODS We randomly assigned 112 children, 2 to 17 years of age, with active systemic JIA (duration of >= 6 months and inad

  8. Asymptomatic carotid stenosis: What we can learn from the next generation of randomized clinical trials

    Directory of Open Access Journals (Sweden)

    Mark N Rubin

    2014-04-01

    Full Text Available Stroke remains an exceedingly incident and prevalent public health burden across the globe, with an estimated 16 million new strokes per annum and prevalence over 60 million, and extracranial internal carotid artery atherosclerotic disease is an important risk factor for stroke. Randomized trials of surgical treatment were conducted (North American Symptomatic Carotid Endarterectomy Trial, European Carotid Surgery Trial and demonstrated efficacy of carotid endarterectomy for secondary prevention of stroke in patients with cerebrovascular events (e.g. ipsilateral stroke, transient ischemic attack, and/or amaurosis fugax attributable to a diseased artery with 50–99% stenosis. Therapeutic clarity, however, proved elusive with asymptomatic carotid artery disease. Asymptomatic Carotid Atherosclerosis Study (ACAS, Asymptomatic Carotid Surgery Trial, and Veterans Affairs Cooperative Study (VACS suggested only modest benefit from surgical intervention for primary stroke prevention and the best medical therapy at the time of these trials is not comparable to modern medical therapy. ACT-1, Asymptomatic Carotid Surgery Trial-2, Stent-Protected Angioplasty in asymptomatic Carotid artery stenosis versus Endarterectomy Trial-2, European Carotid Surgery Trial-2, Carotid Revascularization Endarterectomy Versus Stenting Trial-2 are trials that are recent, ongoing, or in development that include diverse populations across Europe and North America, complementary trial designs, and a collaborative spirit that should provide clinicians with evidence that informs best clinical practice for asymptomatic carotid artery disease.

  9. Neo-adjuvant chemotherapy plus surgery versus surgery alone for cervical cancer: Meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Peng, Yun-Hua; Wang, Xin-Xiu; Zhu, Jing-Song; Gao, Li

    2016-02-01

    The aim of this study was to evaluate the efficacy and safety of neo-adjuvant chemotherapy (NACT) versus radical surgery (RS) for patients with cervical cancer. A meta-analysis of randomized controlled trials (RCT) of NACT + RS versus RS alone for patients with cervical cancer was performed according to the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. The following electronic databases were searched from their inception to April 2015: PUBMED, EMBASE and Cochrane Library. Statistical analysis was done using REVIEW MANAGER 5.3. Five RCT involving 739 patients were studied. There were significant differences between the NACT + RS and the RS-alone groups for positive lymph nodes (OR, 0.45; 95%CI: 0.29-0.70) and parametrial infiltration (OR, 0.48; 95% CI: 0.25-0.92), while treatment efficacy did not differ significantly for 5-year overall survival rate (OR, 1.17; 95% CI: 0.85-1.61), 5-year disease-free survival rate (OR, 1.09; 95% CI: 0.77-1.56) or recurrence rate (OR, 1.17; 95% CI: 0.85-1.61). The results also indicated that chemotherapy-related toxicity was well tolerated. For patients with cervical cancer, NACT could significantly reduce the number of positive lymph nodes and the level of parametrial infiltration compared with RS alone, and be well tolerated. PMID:26807961

  10. Complementary/alternative therapies for premenstrual syndrome: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Stevinson, C; Ernst, E

    2001-07-01

    Complementary/alternative therapies are popular with women who have premenstrual syndrome. This systematic review was designed to determine whether use of such therapies is supported by evidence of effectiveness from rigorous clinical trials. Trials were located through searching 7 databases and checking the reference lists of articles. Randomized controlled trials investigating a complementary/alternative therapy in women with premenstrual syndrome published in the peer-reviewed literature were included in the review. Twenty-seven trials were included investigating herbal medicine (7 trials), homeopathy (1), dietary supplements (13), relaxation (1), massage (1), reflexology (1) chiropractic (1), and biofeedback (2). Despite some positive findings, the evidence was not compelling for any of these therapies, with most trials suffering from various methodological limitations. On the basis of current evidence, no complementary/alternative therapy can be recommended as a treatment for premenstrual syndrome. PMID:11483933

  11. 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

  12. Universal Prevention for Anxiety and Depressive Symptoms in Children: A Meta-analysis of Randomized and Cluster-Randomized Trials.

    Science.gov (United States)

    Ahlen, Johan; Lenhard, Fabian; Ghaderi, Ata

    2015-12-01

    Although under-diagnosed, anxiety and depression are among the most prevalent psychiatric disorders in children and adolescents, leading to severe impairment, increased risk of future psychiatric problems, and a high economic burden to society. Universal prevention may be a potent way to address these widespread problems. There are several benefits to universal relative to targeted interventions because there is limited knowledge as to how to screen for anxiety and depression in the general population. Earlier meta-analyses of the prevention of depression and anxiety symptoms among children suffer from methodological inadequacies such as combining universal, selective, and indicated interventions in the same analyses, and comparing cluster-randomized trials with randomized trials without any correction for clustering effects. The present meta-analysis attempted to determine the effectiveness of universal interventions to prevent anxiety and depressive symptoms after correcting for clustering effects. A systematic search of randomized studies in PsychINFO, Cochrane Library, and Google Scholar resulted in 30 eligible studies meeting inclusion criteria, namely peer-reviewed, randomized or cluster-randomized trials of universal interventions for anxiety and depressive symptoms in school-aged children. Sixty-three percent of the studies reported outcome data regarding anxiety and 87 % reported outcome data regarding depression. Seventy percent of the studies used randomization at the cluster level. There were small but significant effects regarding anxiety (.13) and depressive (.11) symptoms as measured at immediate posttest. At follow-up, which ranged from 3 to 48 months, effects were significantly larger than zero regarding depressive (.07) but not anxiety (.11) symptoms. There was no significant moderation effect of the following pre-selected variables: the primary aim of the intervention (anxiety or depression), deliverer of the intervention, gender distribution

  13. A randomized trial of genetic information for personalized nutrition

    OpenAIRE

    Nielsen, Daiva E.; El-Sohemy, Ahmed

    2012-01-01

    Personal genetic information has become increasingly accessible to the public as a result of direct-to-consumer (DTC) genetic tests; however, concerns have been raised over their value and potential risks. We compared the effects of providing genotype-based dietary advice with general recommendations on behavioral outcomes using a randomized controlled study. Participants were men and women from the Toronto Nutrigenomics and Health Study between the ages of 20–35 years (n = 149) who completed...

  14. Anethum graveolens and hyperlipidemia: A randomized clinical trial

    OpenAIRE

    Mahmoud Mirhosseini; Azar Baradaran; Mahmoud Rafieian-Kopaei

    2014-01-01

    Background: It has been established that hyperlipidemia increases the incidence and mortality associated with coronary heart disease. In this study, the effects of Dill (Anethum graveolens) were evaluated on lipid profile of hypercholesterolemic patients. Materials and Methods: In this clinical study, 91 hyperlipidemic patients were randomly designated into two groups. One group received gemfibrozil (900 mg daily) and the other group received Dill tablet (six tablets daily) for 2 months. The ...

  15. A randomized trial of preoperative oral carbohydrates in abdominal surgery

    OpenAIRE

    Sada, Fatos; Krasniqi, Avdyl; Hamza, Astrit; Gecaj-Gashi, Agreta; Bicaj, Besnik; Kavaja, Floren

    2014-01-01

    Background Carbohydrate-rich liquid drinks (CRLDs) have been recommended to attenuate insulin resistance by shortening the preoperative fasting interval. The aim of our study the effect of preoperative oral administration of CRLDs on the well-being and clinical status of patients. Methods A randomized, double blind, prospective study of patients undergoing open colorectal operations (CR) and open cholecyctectomy (CH) was conducted. Patients were divided into three groups: study, placebo, and ...

  16. Improving aerobic capacity through active videogames: A randomized controlled trial

    OpenAIRE

    Jorge Luiz de Brito-Gomes; Raphael José Perrier-Melo; Erik Anders Wikstrom; Manoel da Cunha Costa

    2015-01-01

    AbstractThe rate of peak workload improvement between different types of Active Video Games (AVG) in young sedentary adults was investigated. Aerobic capacity improvement after a 6-week intervention between AVG types was also compared. Twenty participants, after baseline assessments, were randomized into one of three parallel groups: structured AVG (n= 6), unstructured AVG (n= 7) and a control group (n= 7). Participants played their respective AVG 3 times a week for 6-weeks (30 minutes-sessio...

  17. GENDER-RESPONSIVE DRUG COURT TREATMENT: A Randomized Controlled Trial

    OpenAIRE

    Messina, Nena; Calhoun, Stacy; Warda, Umme

    2012-01-01

    This pilot study compared outcomes for 94 women offenders in San Diego County, California, who participated in four drug court programs. Women were randomized to gender-responsive (GR) programs using Helping Women Recover and Beyond Trauma or standard mixed-gender treatment. Data were collected at program entry, during treatment, and approximately 22 months after treatment entry. Bivariate and multivariate analyses were conducted. Results showed that GR participants had better in-treatment pe...

  18. Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics.

    Science.gov (United States)

    Jackson, George L; Weinberger, Morris; Kirshner, Miriam A; Stechuchak, Karen M; Melnyk, Stephanie D; Bosworth, Hayden B; Coffman, Cynthia J; Neelon, Brian; Van Houtven, Courtney; Gentry, Pamela W; Morris, Isis J; Rose, Cynthia M; Taylor, Jennifer P; May, Carrie L; Han, Byungjoo; Wainwright, Christi; Alkon, Aviel; Powell, Lesa; Edelman, David

    2016-09-01

    Despite the availability of efficacious treatments, only half of patients with hypertension achieve adequate blood pressure (BP) control. This paper describes the protocol and baseline subject characteristics of a 2-arm, 18-month randomized clinical trial of titrated disease management (TDM) for patients with pharmaceutically-treated hypertension for whom systolic blood pressure (SBP) is not controlled (≥140mmHg for non-diabetic or ≥130mmHg for diabetic patients). The trial is being conducted among patients of four clinic locations associated with a Veterans Affairs Medical Center. An intervention arm has a TDM strategy in which patients' hypertension control at baseline, 6, and 12months determines the resource intensity of disease management. Intensity levels include: a low-intensity strategy utilizing a licensed practical nurse to provide bi-monthly, non-tailored behavioral support calls to patients whose SBP comes under control; medium-intensity strategy utilizing a registered nurse to provide monthly tailored behavioral support telephone calls plus home BP monitoring; and high-intensity strategy utilizing a pharmacist to provide monthly tailored behavioral support telephone calls, home BP monitoring, and pharmacist-directed medication management. Control arm patients receive the low-intensity strategy regardless of BP control. The primary outcome is SBP. There are 385 randomized (192 intervention; 193 control) veterans that are predominately older (mean age 63.5years) men (92.5%). 61.8% are African American, and the mean baseline SBP for all subjects is 143.6mmHg. This trial will determine if a disease management program that is titrated by matching the intensity of resources to patients' BP control leads to superior outcomes compared to a low-intensity management strategy.

  19. Questions asked and answered in pilot and feasibility randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Weatherall Mark

    2011-08-01

    Full Text Available Abstract Background In the last decade several authors have reviewed the features of pilot and feasibility studies and advised on the issues that should be addressed within them. We extend this literature by examining published pilot/feasibility trials that incorporate random allocation, examining their stated objectives, results presented and conclusions drawn, and comparing drug and non-drug trials. Methods A search of EMBASE and MEDLINE databases for 2000 to 2009 revealed 3652 papers that met our search criteria. A random sample of 50 was selected for detailed review. Results Most of the papers focused on efficacy: those reporting drug trials additionally addressed safety/toxicity; while those reporting non-drug trials additionally addressed methodological issues. In only 56% (95% confidence intervals 41% to 70% were methodological issues discussed in substantial depth, 18% (95% confidence interval 9% to 30% discussed future trials and only 12% (95% confidence interval 5% to 24% of authors were actually conducting one. Conclusions Despite recent advice on topics that can appropriately be described as pilot or feasibility studies the large majority of recently published papers where authors have described their trial as a pilot or addressing feasibility do not primarily address methodological issues preparatory to planning a subsequent study, and this is particularly so for papers reporting drug trials. Many journals remain willing to accept the pilot/feasibility designation for a trial, possibly as an indication of inconclusive results or lack of adequate sample size.

  20. The Effectiveness of Individualized Acupuncture Protocols in the Treatment of Gulf War Illness: A Pragmatic Randomized Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Lisa Conboy

    Full Text Available Gulf War Illness is a Complex Medical Illness characterized by multiple symptoms, including fatigue, sleep and mood disturbances, cognitive dysfunction, and musculoskeletal pain affecting veterans of the first Gulf War. No standard of care treatment exists.This pragmatic Randomized Clinical Trial tested the effects of individualized acupuncture treatments offered in extant acupuncture practices in the community; practitioners had at least 5 years of experience plus additional training provided by the study. Veterans with diagnosed symptoms of Gulf War Illness were randomized to either six months of biweekly acupuncture treatments (group 1, n = 52 or 2 months of waitlist followed by weekly acupuncture treatments (group 2, n = 52. Measurements were taken at baseline, 2, 4 and 6 months. The primary outcome is the SF-36 physical component scale score (SF-36P and the secondary outcome is the McGill Pain scale.Of the 104 subjects who underwent randomization, 85 completed the protocol (82%. A clinically and statistically significant average improvement of 9.4 points (p = 0.03 in the SF-36P was observed for group 1 at month 6 compared to group 2, adjusting for baseline pain. The secondary outcome of McGill pain index produced similar results; at 6 months, group 1 was estimated to experience a reduction of approximately 3.6 points (p = 0.04 compared to group 2.Individualized acupuncture treatment of sufficient dose appears to offer significant relief of physical disability and pain for veterans with Gulf War Illness. This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Gulf War Illness Research Program under Award No. W81XWH-09-2-0064. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.ClinicalTrials.gov NCT01305811.

  1. Sham Acupressure Controls Used in Randomized Controlled Trials: A Systematic Review and Critique

    OpenAIRE

    Jing-Yu Tan; Lorna K P Suen; Tao Wang; Alexander Molassiotis

    2015-01-01

    Objectives To explore the commonly utilized sham acupressure procedures in existing acupressure trials, and to assess whether different types of sham interventions yield different therapeutic outcomes, and, as far as possible, to identify directions for the future development of an adequate sham acupressure method. Methods Randomized controlled trials comparing true acupressure with sham interventions were included. Thirteen electronic databases were adopted to locate relevant studies from in...

  2. Systematic Review of Randomized Clinical Trials of Acupressure Therapy for Primary Dysmenorrhea

    OpenAIRE

    Hui-ru Jiang; Shuang Ni; Jin-long Li; Miao-miao Liu; Ji Li; Xue-jun Cui; Bi-meng Zhang

    2013-01-01

    The evidence of acupressure is limited in the management of dysmenorrhea. To evaluate the efficacy of acupressure in the treatment of primary dysmenorrhea based on randomized controlled trials (RCTs), we searched MEDLINE, the Chinese Biomedical Database (CBM), and the Cochrane Central Register of Controlled Trials (CENTRAL) databases from inception until March 2012. Two reviewers independently selected articles and extracted data. Statistical analysis was performed with RevMan 5.1 software. E...

  3. Effects of yoga exercises for headaches: a systematic review of randomized controlled trials

    OpenAIRE

    Kim, Sang-Dol

    2015-01-01

    [Purpose] To assess the evidence for the effectiveness of yoga exercises in the management of headaches. [Subjects and Methods] A search was conducted of six electronic databases to identify randomized controlled trials (RCTs) reporting the effects of yogic intervention on headaches published in any language before January 2015. Quality assessment was conducted using the Cochrane risk of bias tool. [Results] One potential trial was identified and included in this review. The quality critical ...

  4. Mental health first aid training for high school teachers: a cluster randomized trial

    OpenAIRE

    Jorm Anthony F; Kitchener Betty A; Sawyer Michael G; Scales Helen; Cvetkovski Stefan

    2010-01-01

    Abstract Background Mental disorders often have their first onset during adolescence. For this reason, high school teachers are in a good position to provide initial assistance to students who are developing mental health problems. To improve the skills of teachers in this area, a Mental Health First Aid training course was modified to be suitable for high school teachers and evaluated in a cluster randomized trial. Methods The trial was carried out with teachers in South Australian high scho...

  5. Questions asked and answered in pilot and feasibility randomized controlled trials

    OpenAIRE

    Weatherall Mark; Pickering Ruth M; Shanyinde Milensu

    2011-01-01

    Abstract Background In the last decade several authors have reviewed the features of pilot and feasibility studies and advised on the issues that should be addressed within them. We extend this literature by examining published pilot/feasibility trials that incorporate random allocation, examining their stated objectives, results presented and conclusions drawn, and comparing drug and non-drug trials. Methods A search of EMBASE and MEDLINE databases for 2000 to 2009 revealed 3652 papers that ...

  6. Randomized, placebo-controlled, double-blind trial of Swedish snus for smoking reduction and cessation

    OpenAIRE

    Nilsson Robert; Antić Ruza; Spasojević-Tišma Vera; Joksić Gordana; Rutqvist Lars E

    2011-01-01

    Abstract Background Epidemiological studies suggest that smokeless tobacco in the form of Swedish snus has been used by many smokers in Scandinavia to quit smoking, but the efficacy of snus has so far not been evaluated in controlled clinical trials. Methods We conducted a randomized, double-blind, placebo-controlled, clinical trial aimed at assessing the efficacy of snus to help adult cigarette smokers in Serbia to substantially reduce, and, eventually, completely stop smoking. The study enr...

  7. Randomized clinical trial of fibrin glue versus tacked fixation in laparoscopic groin hernia repair

    DEFF Research Database (Denmark)

    Tolver, Mette A; Rosenberg, Jacob; Juul, Poul;

    2013-01-01

    BACKGROUND: Preliminary studies have indicated clinical advantages of mesh fixation using fibrin glue in transabdominal preperitoneal groin hernia repair (TAPP)  compared with tack fixation. The aim of this randomized double-blinded, controlled, clinical trial is to compare fibrin glue with tacks...... (p = 0.006). CONCLUSIONS: Fibrin glue compared with tacks fixation improved the early postoperative outcome after TAPP. The trial was registered at clinicaltrials.gov NCT01000116....

  8. Antidepressants for bipolar disorder: A meta-analysis of randomized, double-blind, controlled trials

    OpenAIRE

    Zhang, Yingli; Yang, Huan; Yang, Shichang; Liang, Wei; DAI, Ping; Wang, Changhong; Zhang, Yalin

    2013-01-01

    OBJECTIVE: To examine the efficacy and safety of short-term and long-term use of antidepressants in the treatment of bipolar disorder. DATA SOURCES: A literature search of randomized, double-blind, controlled trials published until December 2012 was performed using the PubMed, ISI Web of Science, Medline and Cochrane Central Register of Controlled Trials databases. The keywords “bipolar disorder, bipolar I disorder, bipolar II disorder, bipolar mania, bipolar depression, cyclothymia, mixed ma...

  9. Effectiveness of antidepressants: an evidence myth constructed from a thousand randomized trials?

    OpenAIRE

    Ioannidis John PA

    2008-01-01

    Abstract Antidepressants, in particular newer agents, are among the most widely prescribed medications worldwide with annual sales of billions of dollars. The introduction of these agents in the market has passed through seemingly strict regulatory control. Over a thousand randomized trials have been conducted with antidepressants. Statistically significant benefits have been repeatedly demonstrated and the medical literature is flooded with several hundreds of "positive" trials (both pre-app...

  10. Rationale and Design of the Informing Fresh versus Old Red Cell Management (INFORM) Trial: An International Pragmatic Randomized Trial.

    Science.gov (United States)

    Eikelboom, John W; Cook, Richard J; Barty, Rebecca; Liu, Yang; Arnold, Donald M; Crowther, Mark A; Devereaux, Philip J; Ellis, Martin; Figueroa, Priscilla; Gallus, Alex; Hirsh, Jack; Kurz, Andrea; Roxby, David; Sessler, Daniel I; Sharon, Yehudit; Sobieraj-Teague, Magdalena; Warkentin, Theodore E; Webert, Kathryn E; Heddle, Nancy M

    2016-01-01

    Although red blood cell transfusion is a potentially lifesaving intervention in severely anemic and acutely bleeding patients, some observational studies have suggested that prolonged red cell storage before transfusion is associated with harm. INFORM is a large, pragmatic, randomized controlled trial comparing the effect of the shorter storage with longer storage red blood cell transfusions on inhospital mortality in hospitalized patients who require a blood transfusion. The trial is being conducted in centers in Australia, Canada, Israel, and the United States and is expected to enroll 31497 patients. If the results of INFORM indicate that shorter storage red blood cell transfusion is associated with superior outcomes compared with standard issue red blood cell transfusion, consideration may be given to shortening blood storage times. If, in contrast, the INFORM trial provides no evidence of harm from longer storage red blood cells, clinicians and patients may be reassured that current blood inventory management strategies are appropriate. PMID:26651419

  11. Community risk factors for ocular Chlamydia infection in Niger: pre-treatment results from a cluster-randomized trachoma trial.

    Directory of Open Access Journals (Sweden)

    Abdou Amza

    Full Text Available BACKGROUND: Trachoma control programs utilize mass azithromycin distributions to treat ocular Chlamydia trachomatis as part of an effort to eliminate this disease world-wide. But it remains unclear what the community-level risk factors are for infection. METHODS: This cluster-randomized, controlled trial entered 48 randomly selected communities in a 2×2 factorial design evaluating the effect of different treatment frequencies and treatment coverage levels. A pretreatment census and examination established the prevalence of risk factors for clinical trachoma and ocular chlamydia infection including years of education of household head, distance to primary water source, presence of household latrine, and facial cleanliness (ocular discharge, nasal discharge, and presence of facial flies. Univariate and multivariate associations were tested using linear regression and Bayes model averaging. FINDINGS: There were a total of 24,536 participants (4,484 children aged 0-5 years in 6,235 households in the study. Before treatment in May to July 2010, the community-level prevalence of active trachoma (TF or TI utilizing the World Health Organization [WHO] grading system was 26.0% (95% CI: 21.9% to 30.0% and the mean community-level prevalence of chlamydia infection by Amplicor PCR was 20.7% (95% CI: 16.5% to 24.9% in children aged 0-5 years. Univariate analysis showed that nasal discharge (0.29, 95% CI: 0.04 to 0.54; P = 0.03, presence of flies on the face (0.40, 95% CI: 0.17 to 0.64; P = 0.001, and years of formal education completed by the head of household (0.07, 95% CI: 0.07 to 0.13; P = 0.03 were independent risk factors for chlamydia infection. In multivariate analysis, facial flies (0.26, 95% CI: 0.02 to 0.49; P = 0.03 and years of formal education completed by the head of household (0.06, 95% CI: 0.008 to 0.11; P = 0.02 were associated risk factors for ocular chlamydial infection. INTERPRETATION: We have found that the presence

  12. Application of dietary fiber in clinical enteral nutrition: A meta-analysis of randomized controlled trials

    Institute of Scientific and Technical Information of China (English)

    Gang Yang; Xiao-Ting Wu; Yong Zhou; Ying-Li Wang

    2005-01-01

    AIM: To evaluate the effects of dietary fiber (DF) as a part of enteral nutrition (EN) formula on diarrhea, infection, and length of hospital stay.METHODS: Following electronic databases were searched for randomized controlled trials about DF: Chinese Biomedicine Database (CBM), MEDLINE, EMBASE and Cochrane Controlled Trials Register. RevMan 4.1 was used for statistical analysis.RESULTS: Seven randomized controlled trials with 400pat-ients were included. The supplement of DF in EN was compared with standard enteral formula in five trials.Combined analysis did not show a significant reduction in occurrence of diarrhea, but there were valuable results for non-critically iii patients. Combined analysis of two trials observing the infection also did not show any valid evidence that DF could decrease the infection rate, though the length of hospital stay was reduced significantly.CONCLUSION: Based on the current eligible randomized controlled trials, there is no evidence that the value of DF in the diarrhea can be proved. Though length of hospital stay was shortened by the use of DF, there is no available evidence in preventing infection by DF. Further studies are needed for evaluating the value of DF in EN.

  13. Comparative efficacy of Lamivudine and emtricitabine: a systematic review and meta-analysis of randomized trials.

    Directory of Open Access Journals (Sweden)

    Nathan Ford

    Full Text Available INTRODUCTION: Lamivudine and emtricitabine are considered equivalent by several guidelines, but evidence of comparable efficacy is conflicting. METHODS: We searched two databases up to June 30 2013 to identify randomized and quasi-randomized trials in which lamivudine and emtricitabine were used as part of combination antiretroviral therapy for treatment-naïve or experienced HIV-positive adult patients. We only included trials where partner drugs in the regimen were identical or could be considered to be comparable. We allowed for comparisons between tenofovir and abacavir provided the study population did not begin treatment with a viral load >100,000 copies/ml. RESULTS: 12 trials contributed 15 different randomized comparisons providing data on 2251 patients receiving lamivudine and 2662 patients receiving emtricitabine. Treatment success was not significantly different in any of the 12 trials. In the three trials that directly compared lamivudine and emtricitabine, the relative risk for achieving treatment success was non-significant (RR 1.03 95%CI 0.96-1.10. For all trials combined, the pooled relative risk for treatment success was not significantly different (RR 1.00, 95%CI 0.97-1.02. No heterogeneity was observed (I (2 = 0. Similarly, there was no difference in the pooled relative risk for treatment failure (RR 1.08, 95%CI 0.94-1.22, I (2 = 3.4%. CONCLUSIONS: The findings of this systematic review suggest that lamivudine and emtricitabine are clinically equivalent.

  14. 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

  15. 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

  16. 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

  17. Prevention of abdominal wound infection (PROUD trial, DRKS00000390: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Heger Ulrike

    2011-11-01

    Full Text Available Abstract Background Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been suggested as an effective measure to decrease postoperative wound infections after laparotomies. The INLINE metaanalysis has recently shown the superiority of a slowly absorbable continuous suture for abdominal closure; with PDS plus® such a suture has now been made available with triclosan antibacterial coating. Methods/Design The PROUD trial is designed as a randomised, controlled, observer, surgeon and patient blinded multicenter superiority trial with two parallel groups and a primary endpoint of wound infection during 30 days after surgery. The intervention group will receive triclosan coated polydioxanone sutures, whereas the control group will receive the standard polydioxanone sutures; abdominal closure will otherwise be standardized in both groups. Statistical analysis is based on intention-to-treat population via binary logistic regression analysis, the total sample size of n = 750 is sufficient to ensure alpha = 5% and power = 80%, an interim analysis will be carried out after data of 375 patients are available. Discussion The PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity. Trial Registration The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390.

  18. Randomized trial of BCG vaccination at birth to low-birth-weight children

    DEFF Research Database (Denmark)

    Aaby, Peter; Roth, Adam Anders Edvin; Ravn, Henrik;

    2011-01-01

    Observational studies have suggested that BCG may have nonspecific beneficial effects on survival. Low-birth-weight (LBW) children are not given BCG at birth in Guinea-Bissau; we conducted a randomized trial of BCG at birth (early BCG) vs delayed BCG.......Observational studies have suggested that BCG may have nonspecific beneficial effects on survival. Low-birth-weight (LBW) children are not given BCG at birth in Guinea-Bissau; we conducted a randomized trial of BCG at birth (early BCG) vs delayed BCG....

  19. SysBank: A Knowledge Base for Systematic Reviews of Randomized Clinical Trials

    OpenAIRE

    Carini, Simona; Sim, Ida

    2003-01-01

    The Systematic Review Bank (SysBank) is a structured knowledge base that captures information about the design, execution, and results of systematic reviews of randomized controlled trials (RCTs). The SysBank data model has been adapted from RCT Bank, a knowledge base of randomized trials, and refined using three published systematic reviews. SysBank links directly to the RCT Bank entries of studies included in the systematic review. SysBank builds upon RCT Bank to support computer-assisted e...

  20. Analysis of cost data in a cluster-randomized, controlled trial: comparison of methods

    DEFF Research Database (Denmark)

    Sokolowski, Ineta; Ørnbøl, Eva; Rosendal, Marianne;

    in clusters of general practices.   There have been suggestions to apply different methods, e.g., the non-parametric bootstrap, to highly skewed data from pragmatic randomized trials without clusters, but there is very little information about how to analyse skewed data from cluster-randomized trials. Many...... studies have used non-valid analysis of skewed data. We propose two different methods to compare mean cost in two groups. Firstly, we use a non-parametric bootstrap method where the re-sampling takes place on two levels in order to take into account the cluster effect. Secondly, we proceed with a log...

  1. Statistical reviewers improve reporting in biomedical articles: a randomized trial.

    Directory of Open Access Journals (Sweden)

    Erik Cobo

    Full Text Available BACKGROUND: Although peer review is widely considered to be the most credible way of selecting manuscripts and improving the quality of accepted papers in scientific journals, there is little evidence to support its use. Our aim was to estimate the effects on manuscript quality of either adding a statistical peer reviewer or suggesting the use of checklists such as CONSORT or STARD to clinical reviewers or both. METHODOLOGY AND PRINCIPAL FINDINGS: Interventions were defined as 1 the addition of a statistical reviewer to the clinical peer review process, and 2 suggesting reporting guidelines to reviewers; with "no statistical expert" and "no checklist" as controls. The two interventions were crossed in a 2x2 balanced factorial design including original research articles consecutively selected, between May 2004 and March 2005, by the Medicina Clinica (Barc editorial committee. We randomized manuscripts to minimize differences in terms of baseline quality and type of study (intervention, longitudinal, cross-sectional, others. Sample-size calculations indicated that 100 papers provide an 80% power to test a 55% standardized difference. We specified the main outcome as the increment in quality of papers as measured on the Goodman Scale. Two blinded evaluators rated the quality of manuscripts at initial submission and final post peer review version. Of the 327 manuscripts submitted to the journal, 131 were accepted for further review, and 129 were randomized. Of those, 14 that were lost to follow-up showed no differences in initial quality to the followed-up papers. Hence, 115 were included in the main analysis, with 16 rejected for publication after peer review. 21 (18.3% of the 115 included papers were interventions, 46 (40.0% were longitudinal designs, 28 (24.3% cross-sectional and 20 (17.4% others. The 16 (13.9% rejected papers had a significantly lower initial score on the overall Goodman scale than accepted papers (difference 15.0, 95% CI: 4

  2. Allocation techniques for balance at baseline in cluster randomized trials: a methodological review

    Directory of Open Access Journals (Sweden)

    Ivers Noah M

    2012-08-01

    Full Text Available Abstract Reviews have repeatedly noted important methodological issues in the conduct and reporting of cluster randomized controlled trials (C-RCTs. These reviews usually focus on whether the intracluster correlation was explicitly considered in the design and analysis of the C-RCT. However, another important aspect requiring special attention in C-RCTs is the risk for imbalance of covariates at baseline. Imbalance of important covariates at baseline decreases statistical power and precision of the results. Imbalance also reduces face validity and credibility of the trial results. The risk of imbalance is elevated in C-RCTs compared to trials randomizing individuals because of the difficulties in recruiting clusters and the nested nature of correlated patient-level data. A variety of restricted randomization methods have been proposed as way to minimize risk of imbalance. However, there is little guidance regarding how to best restrict randomization for any given C-RCT. The advantages and limitations of different allocation techniques, including stratification, matching, minimization, and covariate-constrained randomization are reviewed as they pertain to C-RCTs to provide investigators with guidance for choosing the best allocation technique for their trial.

  3. A cautionary note regarding count models of alcohol consumption in randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Saitz Richard

    2007-02-01

    Full Text Available Abstract Background Alcohol consumption is commonly used as a primary outcome in randomized alcohol treatment studies. The distribution of alcohol consumption is highly skewed, particularly in subjects with alcohol dependence. Methods In this paper, we will consider the use of count models for outcomes in a randomized clinical trial setting. These include the Poisson, over-dispersed Poisson, negative binomial, zero-inflated Poisson and zero-inflated negative binomial. We compare the Type-I error rate of these methods in a series of simulation studies of a randomized clinical trial, and apply the methods to the ASAP (Addressing the Spectrum of Alcohol Problems trial. Results Standard Poisson models provide a poor fit for alcohol consumption data from our motivating example, and did not preserve Type-I error rates for the randomized group comparison when the true distribution was over-dispersed Poisson. For the ASAP trial, where the distribution of alcohol consumption featured extensive over-dispersion, there was little indication of significant randomization group differences, except when the standard Poisson model was fit. Conclusion As with any analysis, it is important to choose appropriate statistical models. In simulation studies and in the motivating example, the standard Poisson was not robust when fit to over-dispersed count data, and did not maintain the appropriate Type-I error rate. To appropriately model alcohol consumption, more flexible count models should be routinely employed.

  4. 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

  5. Effects of yoga on chronic neck pain: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Kim, Sang-Dol

    2016-07-01

    [Purpose] The aim of this study was to investigate the effectiveness of yoga in the management of chronic neck pain. [Subjects and Methods] Five electronic databases were searched to identify randomized controlled trials (RCTs) of yoga intervention on chronic neck pain. The trials were published in the English language between January 1966 and December 2015. The Cochrane Risk of Bias Tool was used to assess the quality of the trials. [Results] Three trials were identified and included in this review. A critical appraisal was performed on the trials, and the result indicated a high risk of bias. A narrative description was processed because of the small number of RCTs. Neck pain intensity and functional disability were significantly lower in the yoga groups than in the control groups. [Conclusion] Evidence from the 3 randomly controlled trials shows that yoga may be beneficial for chronic neck pain. The low-quality result of the critical appraisal and the small number of trials suggest that high-quality RCTs are required to examine further the effects of yoga intervention on chronic neck pain relief. PMID:27512290

  6. Preventing College Women's Sexual Victimization Through Parent Based Intervention: A Randomized Controlled Trial

    OpenAIRE

    Testa, Maria; Hoffman, Joseph H.; Livingston, Jennifer A.; Turrisi, Rob

    2010-01-01

    A randomized controlled trial, using parent-based intervention (PBI) was designed to reduce the incidence of alcohol-involved sexual victimization among first-year college students. The PBI, adapted from Turrisi et al. (2001), was designed to increase alcohol-specific and general communication between mother and daughter. Female graduating high school seniors and their mothers were recruited from the community and randomly assigned to one of four conditions: Alcohol PBI (n=305), Enhanced Alco...

  7. Designing medical and educational intervention studies. A review of some alternatives to conventional randomized controlled trials

    OpenAIRE

    Bradley, Clare

    1993-01-01

    The advantages and limitations of RCT designs are discussed, and a range of alternative designs for medical and educational intervention studies considered. Designs selected are those that address the much neglected psychological issues involved in the recruitment of patients and allocation of patients to treatments within trials. Designs include Zelen's (18) randomized consent design, Brewin and Bradley's (20) partially randomized patient-centered design, and Korn and Baumrind's (21) partial...

  8. Effects of acupressure on progress of labor and cesarean section rate: randomized clinical trial

    OpenAIRE

    Reginaldo Roque Mafetoni; Antonieta Keiko Kakuda Shimo

    2015-01-01

    OBJECTIVE To analyze the effects of acupressure at the SP6 point on labor duration and cesarean section rates in parturients served in a public maternity hospital. METHODS This controlled, randomized, double-blind, pragmatic clinical trial involved 156 participants with gestational age ≥ 37 weeks, cervical dilation ≥ 4 cm, and ≥ 2 contractions in 10 min. The women were randomly divided into an acupressure, placebo, or control group at a university hospital in an inland city in the state of Sa...

  9. A Cluster-Randomized Trial of Insecticide-Treated Curtains for Dengue Vector Control in Thailand

    OpenAIRE

    Lenhart, Audrey; Trongtokit, Yuwadee; Alexander, Neal; Apiwathnasorn, Chamnarn; Satimai, Wichai; Vanlerberghe, Veerle; Van der Stuyft, Patrick; Philip J McCall

    2013-01-01

    The efficacy of insecticide-treated window curtains (ITCs) for dengue vector control was evaluated in Thailand in a cluster-randomized controlled trial. A total of 2,037 houses in 26 clusters was randomized to receive the intervention or act as control (no treatment). Entomological surveys measured Aedes infestations (Breteau index, house index, container index, and pupae per person index) and oviposition indices (mean numbers of eggs laid in oviposition traps) immediately before and after in...

  10. Effects of adjunctive daily phototherapy on chronic periodontitis: a randomized single-blind controlled trial

    OpenAIRE

    Jung, Gyu-Un; Kim, Jin-Woo; Kim, Sun-Jong; Pang, Eun-Kyoung

    2014-01-01

    Purpose The purpose of this randomized single-blind controlled trial was to elucidate the clinical and antimicrobial effects of daily phototherapy (PT) as an adjunct to scaling and root planing (SRP) in patients with chronic periodontitis. Methods The study was conducted from December 2013 to May 2014 at Ewha Womans University Mokdong Hospital, Seoul, Korea. Forty-one patients with mild to moderate chronic periodontitis were randomly divided into two therapeutic groups in a 1:1 ratio: SRP+PT ...

  11. Effect of Rosa aromatherapy on anxiety before cardiac catheterization: A randomized controlled trial

    OpenAIRE

    Atye Babaii; Mohammad Abbasinia; Seyed Fakhreddin Hejazi; Seyyed Reza Seyyed Tabaei; Fariba Dehghani

    2015-01-01

    Background and Objectives: Most patients experience moderate to severe anxiety before cardiac catheterization. This study aimed to investigate the effect of Rosa aromatherapy on anxiety before cardiac catheterization. Methods: In this randomized controlled trial, 60 patients who met the inclusion criteria were conveniently sampled and randomly allocated to the experimental and control groups. Patients in the control group received routine care. In the experimental group, patients received rou...

  12. Oral Doxycycline Reduces Pterygium Lesions; Results from a Double Blind, Randomized, Placebo Controlled Clinical Trial

    OpenAIRE

    Oscar Rúa; Larráyoz, Ignacio M; Barajas, María T.; Sara Velilla; Alfredo Martínez

    2012-01-01

    PURPOSE: To determine whether oral doxycycline treatment reduces pterygium lesions. DESIGN: Double blind, randomized, placebo controlled clinical trial. PARTICIPANTS: 98 adult patients with primary pterygium. METHODS: Patients were randomly assigned to receive 100 mg oral doxycycline twice a day (49 subjects), or placebo (49 subjects), for 30 days. Photographs of the lesion were taken at the time of recruitment and at the end of the treatment. Follow-up sessions were performed 6 and 12 months...

  13. Transcutaneous electric acupoint stimulation at Jiaji points reduce abdominal pain after colonoscopy: a randomized controlled trial

    OpenAIRE

    Chen, Yanqing; Wu, Weilan; Yao, Yusheng; Yang, Yang; Zhao, Qiuyan; Qiu, Liangcheng

    2015-01-01

    Background: Transcutaneous electric acupoint stimulation (TEAS) at Jiaji acupuncture points has therapeutic potential for relieving viscera pain and opioid-related side effects. This prospective, randomized, triple-blinded, placebo-controlled trial was to investigate the efficacy of TEAS on abdominal pain after colonoscopy. Methods: Consecutive outpatients with American Society of Anesthesiologists (ASA) physical status I or II underwent selective colonoscopy were randomly assigned into two g...

  14. Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial

    OpenAIRE

    Usman Anju; Logerquist Sally; Schneider Cindy; Smith Scott; Rossignol Lanier W; Rossignol Daniel A; Neubrander Jim; Madren Eric M; Hintz Gregg; Grushkin Barry; Mumper Elizabeth A

    2009-01-01

    Abstract Background Several uncontrolled studies of hyperbaric treatment in children with autism have reported clinical improvements; however, this treatment has not been evaluated to date with a controlled study. We performed a multicenter, randomized, double-blind, controlled trial to assess the efficacy of hyperbaric treatment in children with autism. Methods 62 children with autism recruited from 6 centers, ages 2–7 years (mean 4.92 ± 1.21), were randomly assigned to 40 hourly treatments ...

  15. Randomized Controlled Trial of Social Media: Effect of Increased Intensity of the Intervention

    OpenAIRE

    Fox, Caroline S; Gurary, Ellen B.; Ryan, John; Bonaca, Marc; Barry, Karen; Loscalzo, Joseph; Massaro, Joseph

    2016-01-01

    Background: A prior randomized controlled trial of social media exposure at Circulation determined that social media did not increase 30‐day page views. Whether insufficient social media intensity contributed to these results is uncertain. Methods and Results: Original article manuscripts were randomized to social media exposure compared with no social media exposure (control) at Circulation beginning in January 2015. Social media exposure consisted of Facebook and Twitter posts on the journa...

  16. Noninvasive Ventilation for Preterm Twin Neonates with Respiratory Distress Syndrome: A Randomized Controlled Trial

    OpenAIRE

    Long Chen; Li Wang; Jie Li; Nan Wang; Yuan Shi

    2015-01-01

    Noninvasive ventilation has been proven to be effective strategies for reducing the need for endotracheal ventilation in preterm infant with respiratory distress syndrome (RDS), however the best option needs to be further determined. A single center, paired design, randomized, controlled trial was conducted between Jan 2011 and July 2014. Preterm twins with RDS were included. One of a pair was randomized to NIPPV, while another to NCPAP. Surfactant was administrated as rescue treatment. The p...

  17. The effects of endometrial injury on intrauterine insemination outcome: A randomized clinical trial

    OpenAIRE

    Afsoon Zarei; Saeed Alborzi; Nasrin Dadras; Ghazal Azadi

    2014-01-01

    Background: Implantation is considered as the rate-limiting step in success of assisted reproduction techniques, and intrauterine insemination cycles. It might be affected by ovarian superovulation and endometrial local scratching. Objective: This study aims to investigate the effect of local endometrial injury on the outcome of IUI cycles. Materials and Methods: In this randomized clinical trial 144 women with unexplained infertility, mild male factor, and mild endometriosis randomly d...

  18. Physical activity, mindfulness meditation, or heart rate variability biofeedback for stress reduction: a randomized controlled trial

    OpenAIRE

    Zwan, van der, G.; Vente, de, W.; Huizink, A.C.; Bögels, S.M.; Bruin, de, B.

    2015-01-01

    In contemporary western societies stress is highly prevalent, therefore the need for stress-reducing methods is great. This randomized controlled trial compared the efficacy of self-help physical activity (PA), mindfulness meditation (MM), and heart rate variability biofeedback (HRV-BF) in reducing stress and its related symptoms. We randomly allocated 126 participants to PA, MM, or HRV-BF upon enrollment, of whom 76 agreed to participate. The interventions consisted of psycho-education and a...

  19. Foot reflexology in feet impairment of people with type 2 diabetes mellitus: randomized trial

    OpenAIRE

    Natália Chantal Magalhães da Silva; Érika de Cássia Lopes Chaves; Emilia Campos de Carvalho; Leonardo César Carvalho; Denise Hollanda Iunes

    2015-01-01

    Abstract Objective: to evaluate the effect of foot reflexology on feet impairment of people with type 2 diabetes mellitus. Method: this is a randomized, controlled and blind clinical trial. The sample was comprised by people with type 2 diabetes mellitus who, after being randomized into Treated group (n = 21) and Control group (n = 24), received guidelines on foot self-care. To the Treated Group it was also provided 12 sessions of foot reflexology. The scores of impairment indicators related ...

  20. Promoting First Relationships: Randomized Trial of a Relationship-Based Intervention for Toddlers in Child Welfare

    OpenAIRE

    Spieker, Susan J.; Oxford, Monica L.; Kelly, Jean F.; Nelson, Elizabeth M.; Fleming, Charles B.

    2012-01-01

    We conducted a community based, randomized control trial of Promoting First Relationships (PFR; Kelly, Sandoval, Zuckerman, & Buehlman, 2008) to improve parenting and toddler outcomes for toddlers in state dependency. Toddlers (10 – 24 months; N = 210) with a recent placement disruption were randomized to 10-week PFR or a comparison condition. Community agency providers were trained to use PFR in the intervention for caregivers. From baseline to post-intervention follow-up, observational rati...

  1. Cluster-Randomized Trial of a Mobile Phone Personalized Behavioral Intervention for Blood Glucose Control

    OpenAIRE

    Quinn, Charlene C.; Shardell, Michelle D; Terrin, Michael L.; Barr, Erik A.; Ballew, Shoshana H.; Gruber-Baldini, Ann L.

    2011-01-01

    OBJECTIVE To test whether adding mobile application coaching and patient/provider web portals to community primary care compared with standard diabetes management would reduce glycated hemoglobin levels in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS A cluster-randomized clinical trial, the Mobile Diabetes Intervention Study, randomly assigned 26 primary care practices to one of three stepped treatment groups or a control group (usual care). A total of 163 patients were enrolled...

  2. The “House Calls” Trial: A Randomized Controlled Trial to Reduce Racial Disparities in Live Donor Kidney Transplantation: Rationale and Design

    OpenAIRE

    Rodrigue, James R.; Pavlakis, Martha; Egbuna, Ogo; Paek, Mathew; Waterman, Amy D; Mandelbrot, Didier A.

    2012-01-01

    Despite a substantially lower rate of live donor kidney transplantation among Black Americans compared to White Americans, there are few systematic efforts to reduce this racial disparity. This paper describes the rationale and design of a randomized controlled trial aims evaluating the comparative effectiveness of three different educational interventions for increasing live donor kidney transplantation in Black Americans. This trial is a single-site, urn-randomized controlled trial with a p...

  3. Reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention

    Directory of Open Access Journals (Sweden)

    Ravaud Philippe

    2009-05-01

    Full Text Available Abstract Background The aim of this study was to assess the reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention. Methods The study design was a methodological systematic review of randomized controlled trials. The data sources were MEDLINE and the Cochrane Central Register of Controlled Trials. All reports of randomized controlled trials assessing stent treatment for coronary disease published between January 1, 2003, and September 30, 2008 were selected. A standardized abstraction form was used to extract data. Results 132 articles were analyzed. Major cardiac adverse events (death, cardiac death, myocardial infarction or stroke were reported as primary or secondary outcomes in 107 reports (81%. However, 19% of the articles contained no data on cardiac events. The mode of data collection of adverse events was given in 29 reports (22% and a definition of expected adverse events was provided in 47 (36%. The length of follow-up was reported in 95 reports (72%. Assessment of adverse events by an adjudication committee was described in 46 reports (35%, and adverse events were described as being followed up for 6 months in 24% of reports (n = 32, between 7 to 12 months in 42% (n = 55 and for more than 1 year in 4% (n = 5. In 115 reports (87%, numerical data on the nature of the adverse events were reported per treatment arm. Procedural complications were described in 30 articles (23%. The causality of adverse events was reported in only 4 articles. Conclusion Several harm-related data were not adequately accounted for in articles of randomized controlled trials assessing stents for percutaneous coronary intervention. Trials Registration Trials manuscript: 5534201182098351 (T80802P

  4. Pulse versus daily oral cyclophosphamide for induction of remission in antineutrophil cytoplasmic antibody-associated vasculitis: a randomized trial

    DEFF Research Database (Denmark)

    de Groot, Kirsten; Harper, Lorraine; Jayne, David R W;

    2009-01-01

    BACKGROUND: Current therapies for antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis are limited by toxicity. OBJECTIVE: To compare pulse cyclophosphamide with daily oral cyclophosphamide for induction of remission. DESIGN: Randomized, controlled trial. Random assignments were...

  5. Acupuncture for Functional Dyspepsia: A Single Blinded, Randomized, Controlled Trial

    Directory of Open Access Journals (Sweden)

    Yulian Jin

    2015-01-01

    Full Text Available In order to investigate the therapeutic potential of acupuncture on patients with functional dyspepsia (FD, patients were randomized to receive acupuncture at classic acupoints with manipulations (treatment group versus acupuncture at nonacupoints without manipulation (control group once every other day, three times a week, for one month and were followed up for three months. The primary outcomes included dyspeptic symptoms, quality of life, and mental status. The secondary outcomes included the fasting serum gastrin concentration, and frequency and propagation velocity of gastric slow waves. Sixty patients with FD were included, among whom, four dropped out. After one month's treatment, patients with FD showed significant improvements in primary (in both groups and secondary (in the eight patients of the treatment group outcomes as compared with baseline (P=0.0078 to <0.0001; treatment group has better outcomes in all primary outcome measures (P<0.0001 except for SDS (P=0.0005. Improvements on dyspeptic symptoms persist during follow-up (better in the treatment group. Acupuncture with manual manipulation had better effects on improving dyspeptic symptoms, mental status, and quality of life in patients with FD. These effects may be related to the increased frequency and propagation speed of gastric slow waves and serum gastrin secretion.

  6. Improving aerobic capacity through active videogames: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jorge Luiz de Brito-Gomes

    2015-09-01

    Full Text Available AbstractThe rate of peak workload improvement between different types of Active Video Games (AVG in young sedentary adults was investigated. Aerobic capacity improvement after a 6-week intervention between AVG types was also compared. Twenty participants, after baseline assessments, were randomized into one of three parallel groups: structured AVG (n= 6, unstructured AVG (n= 7 and a control group (n= 7. Participants played their respective AVG 3 times a week for 6-weeks (30 minutes-session. The control group maintained normal activities. Both structured and unstructured AVG improved peak workload after four weeks but only the structured group maintained this improvement through week five and six. Aerobic capacity improved in the unstructured (Pre: 36.0 ± 5.2ml.kg.min-¹,Post: 39.7 ± 4.9ml.kg.min-¹, p = .038 and structured AVG (Pre: 39.0 ± 5.9ml.kg.min-¹,Post: 47.8 ± 4.3ml.kg.min-¹, p = .006 groups. Structured AVG provide greater health benefits to aerobic capacity and peak workload in young sedentary but otherwise healthy males relative to unstructured AVG.

  7. Carnosine treatment for gulf war illness: a randomized controlled trial.

    Science.gov (United States)

    Baraniuk, James Nicholas; El-Amin, Suliman; Corey, Rebecca; Rayhan, Rakib; Timbol, Christian

    2013-05-01

    About 25% of 1990-1991 Persian Gulf War veterans experience disabling fatigue, widespread pain, and cognitive dysfunction termed Gulf War illness (GWI) or Chronic Multisymptom Illness (CMI). A leading theory proposes that wartime exposures initiated prolonged production of reactive oxygen species (ROS) and central nervous system injury. The endogenous antioxidant L-carnosine (B-alanyl-L-histidine) is a potential treatment since it is a free radical scavenger in nervous tissue. To determine if nutritional supplementation with L-carnosine would significantly improve pain, cognition and fatigue in GWI, a randomized double blind placebo controlled 12 week dose escalation study involving 25 GWI subjects was employed. L-carnosine was given as 500, 1000, and 1500 mg increasing at 4 week intervals. Outcomes included subjective fatigue, pain and psychosocial questionnaires, and instantaneous fatigue and activity levels recorded by ActiWatch Score devices. Cognitive function was evaluated by WAIS-R digit symbol substitution test. Carnosine had 2 potentially beneficial effects: WAIS-R scores increased significantly, and there was a decrease in diarrhea associated with irritable bowel syndrome. No other significant incremental changes were found. Therefore, 12 weeks of carnosine (1500 mg) may have beneficial cognitive effects in GWI. Fatigue, pain, hyperalgesia, activity and other outcomes were resistant to treatment. PMID:23618477

  8. Prize Contingency Management for Smoking Cessation: A Randomized Trial

    Science.gov (United States)

    Ledgerwood, David M.; Arfken, Cynthia L.; Petry, Nancy M.; Alessi, Sheila M.

    2016-01-01

    Background Adjunctive behavioral smoking cessation treatments have the potential to improve outcomes beyond standard care. The present study had two aims: 1) compare standard care (SC) for smoking (four weeks of brief counseling and monitoring) to SC plus prize-based contingency management (CM), involving the chance to earn prizes on days with demonstrated smoking abstinence (carbon monoxide (CO) ≤6ppm); and 2) compare the relative efficacy of two prize reinforcement schedules - one a traditional CM schedule, and the second an early enhanced CM schedule providing greater reinforcement magnitude in the initial week of treatment but equal overall reinforcement. Methods Participants (N = 81 nicotine-dependent cigarette smokers) were randomly assigned to one of the three conditions. Results Prize CM resulted in significant reductions in cigarette smoking relative to SC. These reductions were not apparent at follow-up. We found no meaningful differences between the traditional and enhanced CM conditions. Conclusions Our findings reveal that prize CM leads to significant reductions in smoking during treatment relative to a control intervention, but the benefits did not extend long-term. PMID:24793364

  9. Self-monitoring of reexperiencing symptoms: a randomized trial.

    Science.gov (United States)

    Brown, Amanda Joelle; Bollini, Annie M; Craighead, Linda W; Astin, Millie C; Norrholm, Seth Davin; Bradley, Bekh

    2014-10-01

    The efficacy of a brief intervention to self-monitor reexperiencing symptoms was evaluated in 137 U.S. combat veterans with PTSD who were enrolled in 5-week psychoeducation groups at a large Veterans Affairs Medical Center. Groups were randomized to psychoeducation alone (Education Control, n = 50) or psychoeducation plus intrusion monitoring (Education + Monitoring, n = 87). Education + Monitoring participants were asked to make a daily record of the number and content of nightmares, flashbacks, intrusive trauma-related thoughts, and physiological and emotional reactions to triggers. Avoidance symptoms were reduced in both conditions (η(2)  = .093), with no additional benefit from intrusion monitoring (η(2)  = .001). Compliance with intrusion monitoring was markedly low, which complicated the interpretation of the study findings. Even though intrusion monitoring has a strong theoretical foundation and may be an efficient and cost-effective alternative to more structured treatments for PTSD, the effect of intrusion monitoring will not be clearly understood until higher compliance can be achieved. Future work in this area should address barriers to compliance and investigate strategies for enhancing motivation to engage in self-monitoring. PMID:25322881

  10. 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

  11. Position of the physician's nametag--a randomized, blinded trial.

    Directory of Open Access Journals (Sweden)

    Samuel Luca Schmid

    Full Text Available The patient-physician relation begins when the physician introduces himself with name and function. Most institutions request a nametag with name and function to be worn. Although nametags are consequently worn, the optimal position for the nametag is unknown. It was the purpose of this study to identify whether positioning the nametag on the right or the left chest side provides better visibility to the patient.One hundred volunteers, blinded to the experimental setup, presented for an orthopedic consultation in a standardized manner. The nametag of the physician was randomly positioned on the left chest side and presented to 50 individuals (age 35 years (range 17 to 83 or the right chest side and then presented to 50 other individuals (35 years (range 16 to 59. The time of the participant noticing the nametag was documented. Subsequently, the participant was questioned concerning the relevance of a nametag and verbal self-introduction of the physician.38% of the participants noticed the nametag on the right as opposed to 20% who noticed it if placed on the left upper chest (p = 0.0473. The mean time to detection was 9 (range 1-40 seconds for nametags on the right and 25.2 seconds (range 3 to 49, p = 0.006 on the left. For 87% of the participants, a nametag is expected and important and nearly all participants (96% expected the physician to introduce himself verbally.It is expected that a physician wears a nametag and introduce himself verbally at the first encounter. Positioning the nametag on the right chest side results in better and faster visibility.

  12. Nurse Family Partnership: Comparing Costs per Family in Randomized Trials Versus Scale-Up.

    Science.gov (United States)

    Miller, Ted R; Hendrie, Delia

    2015-12-01

    The literature that addresses cost differences between randomized trials and full-scale replications is quite sparse. This paper examines how costs differed among three randomized trials and six statewide scale-ups of nurse family partnership (NFP) intensive home visitation to low income first-time mothers. A literature review provided data on pertinent trials. At our request, six well-established programs reported their total expenditures. We adjusted the costs to national prices based on mean hourly wages for registered nurses and then inflated them to 2010 dollars. A centralized data system provided utilization. Replications had fewer home visits per family than trials (25 vs. 31, p = .05), lower costs per client ($8860 vs. $12,398, p = .01), and lower costs per visit ($354 vs. $400, p = .30). Sample size limited the significance of these differences. In this type of labor intensive program, costs probably were lower in scale-up than in randomized trials. Key cost drivers were attrition and the stable caseload size possible in an ongoing program. Our estimates reveal a wide variation in cost per visit across six state programs, which suggests that those planning replications should not expect a simple rule to guide cost estimations for scale-ups. Nevertheless, NFP replications probably achieved some economies of scale.

  13. Nurse Family Partnership: Comparing Costs per Family in Randomized Trials Versus Scale-Up.

    Science.gov (United States)

    Miller, Ted R; Hendrie, Delia

    2015-12-01

    The literature that addresses cost differences between randomized trials and full-scale replications is quite sparse. This paper examines how costs differed among three randomized trials and six statewide scale-ups of nurse family partnership (NFP) intensive home visitation to low income first-time mothers. A literature review provided data on pertinent trials. At our request, six well-established programs reported their total expenditures. We adjusted the costs to national prices based on mean hourly wages for registered nurses and then inflated them to 2010 dollars. A centralized data system provided utilization. Replications had fewer home visits per family than trials (25 vs. 31, p = .05), lower costs per client ($8860 vs. $12,398, p = .01), and lower costs per visit ($354 vs. $400, p = .30). Sample size limited the significance of these differences. In this type of labor intensive program, costs probably were lower in scale-up than in randomized trials. Key cost drivers were attrition and the stable caseload size possible in an ongoing program. Our estimates reveal a wide variation in cost per visit across six state programs, which suggests that those planning replications should not expect a simple rule to guide cost estimations for scale-ups. Nevertheless, NFP replications probably achieved some economies of scale. PMID:26507844

  14. Results of the Randomized Danish Lung Cancer Screening Trial with Focus on High-Risk Profiling

    DEFF Research Database (Denmark)

    M. W. Wille, Mathilde; Dirksen, Asger; Ashraf, Haseem;

    2016-01-01

    RATIONALE: As of April 2015, participants in the Danish Lung Cancer Screening Trial had been followed for at least 5 years since their last screening. OBJECTIVES: Mortality, causes of death, and lung cancer findings are reported to explore the effect of computed tomography (CT) screening. METHODS...... fewer deaths in the screening group. CONCLUSIONS: No statistically significant effects of CT screening on lung cancer mortality were found, but the results of post hoc high-risk subgroup analyses showed nonsignificant trends that seem to be in good agreement with the results of the National Lung...

  15. Defining a COPD composite safety endpoint for demonstrating efficacy in clinical trials: results from the randomized, placebo-controlled UPLIFT® trial

    OpenAIRE

    Celli, Bartolomé R; Decramer, Marc; Liu, Dacheng; Metzdorf, Norbert; Asijee, Guus M; Tashkin, Donald P.

    2016-01-01

    Background Chronic obstructive pulmonary disease (COPD) clinical trials evaluating hard endpoints (mortality, hospitalized exacerbations) require a large number of subjects and prolonged observational periods. We hypothesized that a composite endpoint of respiratory outcomes (CERO) can help evaluate safety and benefit in COPD trials. Methods Retrospective analysis of 5992 patients enrolled in the 4-year UPLIFT® trial, a randomized trial of tiotropium versus placebo in patients with moderate-t...

  16. Explaining Feast or Famine in Randomized Field Trials: Medical Science and Criminology Compared.

    Science.gov (United States)

    Shepherd, Jonathan P.

    2003-01-01

    Discusses the contrast between the frequency of randomized clinical trials in the health sciences and the relative famine of such studies in criminology. Attributes this difference to the contexts in which research is done and the difference in the status of situational research in the two disciplines. (SLD)

  17. Financial Incentives and Student Achievement: Evidence from Randomized Trials. NBER Working Paper No. 15898

    Science.gov (United States)

    Fryer, Roland G., Jr.

    2010-01-01

    This paper describes a series of school-based randomized trials in over 250 urban schools designed to test the impact of financial incentives on student achievement. In stark contrast to simple economic models, our results suggest that student incentives increase achievement when the rewards are given for inputs to the educational production…

  18. Cognitive-Behavioral Therapy for Intermittent Explosive Disorder: A Pilot Randomized Clinical Trial

    Science.gov (United States)

    McCloskey, Michael S.; Noblett, Kurtis L.; Deffenbacher, Jerry L.; Gollan, Jackie K.; Coccaro, Emil F.

    2008-01-01

    No randomized clinical trials have evaluated the efficacy of psychotherapy for intermittent explosive disorder (IED). In the present study, the authors tested the efficacy of 12-week group and individual cognitive-behavioral therapies (adapted from J. L. Deffenbacher & M. McKay, 2000) by comparing them with a wait-list control in a randomized…

  19. Economic evaluation of occupational therapy in Parkinson's disease: A randomized controlled trial

    NARCIS (Netherlands)

    Sturkenboom, I.H.W.M.; Hendriks, J.C.M.; Graff, M.J.L.; Adang, E.M.M.; Munneke, M.; Nijhuis, M.W.; Bloem, B.R.

    2015-01-01

    BACKGROUND: A large randomized clinical trial (the Occupational Therapy in Parkinson's Disease [OTiP] study) recently demonstrated that home-based occupational therapy improves perceived performance in daily activities of people with Parkinson's disease (PD). The aim of the current study was to eval

  20. Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial.

    NARCIS (Netherlands)

    Hoeksma, H.L.; Dekker, J.; Ronday, H.K.; Heering, A.; Lubbe, N. van der; Vel, C.; Breedveld, F.C.; Ende, C.H.M. van den

    2004-01-01

    OBJECTIVE: To determine the effectiveness of a manual therapy program compared with an exercise therapy program in patients with osteoarthritis (OA) of the hip. METHODS: A single-blind, randomized clinical trial of 109 hip OA patients was carried out in the outpatient clinic for physical therapy of

  1. Nasal Oxytocin for Social Deficits in Childhood Autism: A Randomized Controlled Trial

    Science.gov (United States)

    Dadds, Mark R.; MacDonald, Elayne; Cauchi, Avril; Williams, Katrina; Levy, Florence; Brennan, John

    2014-01-01

    The last two decades have witnessed a surge in research investigating the application of oxytocin as a method of enhancing social behaviour in humans. Preliminary evidence suggests oxytocin may have potential as an intervention for autism. We evaluated a 5-day "live-in" intervention using a double-blind randomized control trial. 38 male…

  2. Dealing with missing outcome data in randomized trials and observational studies.

    NARCIS (Netherlands)

    Groenwold, R.H.; Donders, A.R.T.; Roes, K.C.; Harrell Jr, F.E.; Moons, K.G.

    2012-01-01

    Although missing outcome data are an important problem in randomized trials and observational studies, methods to address this issue can be difficult to apply. Using simulated data, the authors compared 3 methods to handle missing outcome data: 1) complete case analysis; 2) single imputation; and 3)

  3. Effects of Folic Acid Supplementation on Hearing in Older Adults: a Randomized, Controlled Trial

    NARCIS (Netherlands)

    Durga, J.; Verhoef, P.; Anteunis, L.J.C.; Schouten, E.G.; Kok, F.J.

    2007-01-01

    Background: Age-related hearing loss is a common chronic condition of elderly persons. Low folate status has been associated with poor hearing. Objective: To determine whether folic acid supplementation slows age-related hearing loss. Design: Double-blind, randomized, placebo-controlled trial conduc

  4. Randomized controlled trial to assess the effectiveness of a videotape about radiotherapy

    OpenAIRE

    Harrison, R; Dey, P.; Slevin, N J; Eardley, A; Gibbs, A; Cowan, R.; Logue, J P; Leidecker, V; Hopwood, P

    2001-01-01

    In a randomized controlled trial, the additional provision of information on videotape was no more effective than written information alone in reducing pre-treatment worry about radiotherapy. Images of surviving cancer patients, however, may provide further reassurance to patients once therapy is completed. © 2001 Cancer Research Campaign http://www.bjcancer.com

  5. Is Personality a Key Predictor of Missing Study Data? An Analysis From a Randomized Controlled Trial

    OpenAIRE

    Jerant, Anthony; Chapman, Benjamin P.; Duberstein, Paul; Franks, Peter

    2009-01-01

    PURPOSE Little is known regarding the effects of psychological factors on data collection in research studies. We examined whether Five Factor Model (FFM) personality factors—Neuroticism, Extraversion, Openness, Agreeableness, and Conscientiousness—predicted missing data in a randomized controlled trial (RCT).

  6. Assessing Impact and Bridging Methodological Divides: Randomized Trials in Countries Affected by Conflict

    Science.gov (United States)

    Burde, Dana

    2012-01-01

    Randomized trials have experienced a marked surge in endorsement and popularity in education research in the past decade. This surge reignited paradigm debates and spurred qualitative critics to accuse these experimental designs of eclipsing qualitative research. This article reviews a current iteration of this debate and examines two randomized…

  7. Standardized Effect Size Measures for Mediation Analysis in Cluster-Randomized Trials

    Science.gov (United States)

    Stapleton, Laura M.; Pituch, Keenan A.; Dion, Eric

    2015-01-01

    This article presents 3 standardized effect size measures to use when sharing results of an analysis of mediation of treatment effects for cluster-randomized trials. The authors discuss 3 examples of mediation analysis (upper-level mediation, cross-level mediation, and cross-level mediation with a contextual effect) with demonstration of the…

  8. Why Randomized Trials Are Challenging within Adventure Therapy Research: Lessons Learned in Norway

    Science.gov (United States)

    Gabrielsen, Leiv Einar; Fernee, Carina Ribe; Aasen, Gunnar Oland; Eskedal, Leif Torvald

    2016-01-01

    There are few high-quality studies using randomized controlled trials (RCTs) in the adventure and wilderness therapy literature. Thus, a unison call is heard for more such studies to be carried out. This article presents a Norwegian wilderness therapy research project that planned to incorporate this "gold standard" that is regarded as…

  9. Testing Mediators of Intervention Effects in Randomized Controlled Trials: An Evaluation of Three Depression Prevention Programs

    Science.gov (United States)

    Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.

    2010-01-01

    Objective: Evaluate a new 5-step method for testing mediators hypothesized to account for the effects of depression prevention programs. Method: In this indicated prevention trial, at-risk teens with elevated depressive symptoms were randomized to a group cognitive-behavioral (CB) intervention, group supportive expressive intervention, CB…

  10. Attachment-Based Family Therapy for Adolescents with Suicidal Ideation: A Randomized Controlled Trial

    Science.gov (United States)

    Diamond, Guy S.; Wintersteen, Matthew B.; Brown, Gregory K.; Diamond, Gary M.; Gallop, Robert; Shelef, Karni; Levy, Suzanne

    2010-01-01

    Objective: To evaluate whether Attachment-Based Family Therapy (ABFT) is more effective than Enhanced Usual Care (EUC) for reducing suicidal ideation and depressive symptoms in adolescents. Method: This was a randomized controlled trial of suicidal adolescents between the ages of 12 and 17, identified in primary care and emergency departments. Of…

  11. 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).…

  12. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial.

    LENUS (Irish Health Repository)

    McDonnell, John G

    2007-01-01

    The transversus abdominis plane (TAP) block is a novel approach for blocking the abdominal wall neural afferents via the bilateral lumbar triangles of Petit. We evaluated its analgesic efficacy in patients during the first 24 postoperative hours after abdominal surgery, in a randomized, controlled, double-blind clinical trial.

  13. RANDOMIZED CONTROLLED TRIALS OF MATERNAL-FETAL SURGERY : A CHALLENGE TO CLINICAL EQUIPOISE

    NARCIS (Netherlands)

    Rodrigues, H. C. M. L.; van den Berg, P. P.

    2014-01-01

    This article focuses on maternal-fetal surgery (MFS) and on the concept of clinical equipoise that is a widely accepted requirement for conducting randomized controlled trials (RCT). There are at least three reasons why equipoise is unsuitable for MFS. First, the concept is based on a misconception

  14. A Pilot Randomized Controlled Trial of Omega-3 Fatty Acids for Autism Spectrum Disorder

    Science.gov (United States)

    Bent, Stephen; Bertoglio, Kiah; Ashwood, Paul; Bostrom, Alan; Hendren, Robert L.

    2011-01-01

    We conducted a pilot randomized controlled trial to determine the feasibility and initial safety and efficacy of omega-3 fatty acids (1.3 g/day) for the treatment of hyperactivity in 27 children ages 3-8 with autism spectrum disorder (ASD). After 12 weeks, hyperactivity, as measured by the Aberrant Behavior Checklist, improved 2.7 (plus or minus…

  15. Mainstreaming Remedial Mathematics Students in Introductory Statistics: Results Using a Randomized Controlled Trial

    Science.gov (United States)

    Logue, Alexandra W.; Watanabe-Rose, Mari

    2014-01-01

    This study used a randomized controlled trial to determine whether students, assessed by their community colleges as needing an elementary algebra (remedial) mathematics course, could instead succeed at least as well in a college-level, credit-bearing introductory statistics course with extra support (a weekly workshop). Researchers randomly…

  16. Randomized Controlled Trial of the Focus Parent Training for Toddlers with Autism: 1-Year Outcome

    Science.gov (United States)

    Oosterling, Iris; Visser, Janne; Swinkels, Sophie; Rommelse, Nanda; Donders, Rogier; Woudenberg, Tim; Roos, Sascha; van der Gaag, Rutger Jan; Buitelaar, Jan

    2010-01-01

    This randomized controlled trial compared results obtained after 12 months of nonintensive parent training plus care-as-usual and care-as-usual alone. The training focused on stimulating joint attention and language skills and was based on the intervention described by Drew et al. (Eur Child Adolesc Psychiatr 11:266-272, 2002). Seventy-five…

  17. Randomized controlled trial of surface peroneal nerve stimulation for motor relearning in lower limb hemiparesis

    NARCIS (Netherlands)

    Sheffler, L.R.; Taylor, P.N.; Gunzler, D.D.; Buurke, J.H.; IJzerman, M.J.; Chae, J.

    2013-01-01

    Objective: To compare the motor relearning effect of a surface peroneal nerve stimulator (PNS) versus usual care on lower limb motor impairment, activity limitation, and quality of life among chronic stroke survivors. Design: Single-blinded randomized controlled trial. Setting: Teaching hospital of

  18. Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants

    Science.gov (United States)

    Our objective was to compare the duration of parenteral nutrition, growth, and morbidity in extremely premature infants fed exclusive diets of either bovine milk-based preterm formula (BOV) or donor human milk and human milk-based human milk fortifier (HUM), in a randomized trial of formula vs human...

  19. Learning Mathematics in a Visuospatial Format: A Randomized, Controlled Trial of Mental Abacus Instruction

    Science.gov (United States)

    Barner, David; Alvarez, George; Sullivan, Jessica; Brooks, Neon; Srinivasan, Mahesh; Frank, Michael C.

    2016-01-01

    Mental abacus (MA) is a technique of performing fast, accurate arithmetic using a mental image of an abacus; experts exhibit astonishing calculation abilities. Over 3 years, 204 elementary school students (age range at outset: 5-7 years old) participated in a randomized, controlled trial to test whether MA expertise (a) can be acquired in standard…

  20. Increasing the Degrees of Freedom in Future Group Randomized Trials: The "df*" Method Revisited

    Science.gov (United States)

    Murray, David M.; Blitstein, Jonathan L.; Hannan, Peter J.; Shadish, William R.

    2012-01-01

    Background: This article revisits an article published in Evaluation Review in 2005 on sample size estimation and power analysis for group-randomized trials. With help from a careful reader, we learned of an important error in the spreadsheet used to perform the calculations and generate the results presented in that article. As we studied the…

  1. Cyanoacrylate Skin Microsealant for Preventing Surgical Site Infection after Vascular Surgery : A Discontinued Randomized Clinical Trial

    NARCIS (Netherlands)

    Vierhout, Bastiaan P.; Ott, Alewijn; Reijnen, Michel M. P. J.; Oskam, Jacques; Ott, Alewijn; van den Dungen, Jan J. A. M.; Zeebregts, Clark J.

    2014-01-01

    Background: Surgical site infections (SSI) after vascular surgery are related to substantial morbidity. Restriction of bacterial access to the site of surgery with a cyanoacrylate sealant is a new concept. We performed a randomized clinical trial to assess the effect of the sealing of skin with a cy

  2. Timing of elective cesarean section and neonatal morbidity: A randomized controlled trial

    DEFF Research Database (Denmark)

    Glavind, Julie; Kindberg, Sara Fevre; Uldbjerg, Niels;

    2012-01-01

    Objective Neonatal complications related to timing of elective cesarean section (ECS) have never been studied in randomized trials. We designed the first randomized trial of timing of ECS and hypothesized a decrease in neonatal admission rate if ECS was scheduled after 39 completed weeks of gesta......Objective Neonatal complications related to timing of elective cesarean section (ECS) have never been studied in randomized trials. We designed the first randomized trial of timing of ECS and hypothesized a decrease in neonatal admission rate if ECS was scheduled after 39 completed weeks....... Diabetics and women with an estimated high risk of having ECS before 39 weeks and 5 days of gestation were excluded. The primary outcome was admission to the Neonatal Intensive Care Unit within 48 hours of birth. Results From March 2009 to June 2011 1274 women from seven Danish hospitals were enrolled....... Baseline characteristics were similar in intervention groups. No significant difference in primary outcome was found between ECS delivery at 38+3 weeks (88/635 neonates or 13.9% admitted) and ECS delivery at 39+3 weeks (76/637 neonates or 11.9% admitted), RR 0.86 (95% CI 0.65-1.15). Compliance was defined...

  3. A Randomized Trial of Probation Case Management for Drug-Involved Women Offenders

    Science.gov (United States)

    Guydish, Joseph; Chan, Monica; Bostrom, Alan; Jessup, Martha A.; Davis, Thomas B.; Marsh, Cheryl

    2011-01-01

    This article reports findings from a clinical trial of a probation case management (PCM) intervention for drug-involved women offenders. Participants were randomly assigned to PCM (n = 92) or standard probation (n = 91) and followed for 12 months using measures of substance abuse, psychiatric symptoms, social support, and service utilization.…

  4. Genetic susceptibility testing and readiness to control weight: Results from a randomized controlled trial

    NARCIS (Netherlands)

    Meisel, S.F.; Beeken, R.J.; Jaarsveld, C.H.M. van; Wardle, J.

    2015-01-01

    OBJECTIVE: To test the hypothesis that adding obesity gene feedback (FTO) to simple weight control advice at a life stage with raised risk of weight gain (university) increases readiness to control weight. METHODS: Individually randomized controlled trial comparing the effect of: (i) simple weight c

  5. Improving the General Language Skills of Second-Language Learners in Kindergarten: A Randomized Controlled Trial

    Science.gov (United States)

    Rogde, Kristin; Melby-Lervåg, Monica; Lervåg, Arne

    2016-01-01

    Second-language learners display poorer general language skills in the language used at school than their monolingual peers, which is a concern because general language skills (vocabulary, grammar, language expression, and comprehension) provide the foundation for later academic success. In a randomized controlled trial, we examined the efficacy…

  6. Effect of Improving the Usability of an E-Learning Resource: A Randomized Trial

    Science.gov (United States)

    Davids, Mogamat Razeen; Chikte, Usuf M. E.; Halperin, Mitchell L.

    2014-01-01

    Optimizing the usability of e-learning materials is necessary to reduce extraneous cognitive load and maximize their potential educational impact. However, this is often neglected, especially when time and other resources are limited. We conducted a randomized trial to investigate whether a usability evaluation of our multimedia e-learning…

  7. A Compound Herbal Preparation (CHP) in the Treatment of Children with ADHD: A Randomized Controlled Trial

    Science.gov (United States)

    Katz, M.; Adar Levine, A.; Kol-Degani, H.; Kav-Venaki, L.

    2010-01-01

    Objective: Evaluation of the efficacy of a patented, compound herbal preparation (CHP) in improving attention, cognition, and impulse control in children with ADHD. Method: Design: A randomized, double-blind, placebo-controlled trial. Setting: University-affiliated tertiary medical center. Participants: 120 children newly diagnosed with ADHD,…

  8. Urinary isoflavonoid excretion as a biomarker of dietary soy intake during two randomized soy trials

    OpenAIRE

    Morimoto, Yukiko; Beckford, Fanchon; Franke, Adrian A.; Maskarinec, Gertraud

    2014-01-01

    We evaluated urinary isoflavonoid excretion as a biomarker of dietary isoflavone intake during two randomized soy trials (13–24 months) among 256 premenopausal women with a total of 1,385 repeated urine samples. Participants consumed a high-soy diet (2 servings/day) and a low-soy diet (

  9. Effectiveness in practice-based research: Looking for alternatives to the randomized controlled trial (RCT)

    NARCIS (Netherlands)

    L. Tavecchio

    2015-01-01

    Over the last decade, the status of the randomized controlled trial (RCT), hallmark of evidence-based medicine (research), has been growing strongly in general practice, social work and public health. But this type of research is only practicable under strictly controlled and well-defined settings a

  10. Moderate-to-High Intensity Physical Exercise in Patients with Alzheimer's Disease: A Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Hoffmann, Kristine; Sobol, Nanna A; Frederiksen, Kristian S;

    2015-01-01

    Background: Studies of physical exercise in patients with Alzheimer’s disease (AD) are few and results have been inconsistent. Objective: To assess the effects of a moderate-to-high intensity aerobic exercise program in patients with mild AD. Methods: In a randomized controlled trial, we recruited...

  11. Sibling Outcomes from a Randomized Trial of Evidence-Based Treatments with Substance Abusing Juvenile Offenders

    Science.gov (United States)

    Rowland, Melisa D.; Chapman, Jason E.; Henggeler, Scott W.

    2008-01-01

    This study examined the substance use and delinquency outcomes for the nearest age siblings of substance abusing and delinquent adolescents that participated in a randomized clinical trial evaluating the effectiveness of integrating evidence-based practices into juvenile drug court. The sample of 70 siblings averaged 14.4 years of age, 50% were…

  12. Cancer Screening Knowledge Changes: Results from a Randomized Control Trial of Women with Developmental Disabilities

    Science.gov (United States)

    Parish, Susan L.; Rose, Roderick A.; Luken, Karen; Swaine, Jamie G.; O'Hare, Lindsey

    2012-01-01

    Background: Women with developmental disabilities are much less likely than nondisabled women to receive cervical and breast cancer screening according to clinical guidelines. One barrier to receipt of screenings is a lack of knowledge about preventive screenings. Method: To address this barrier, we used a randomized control trial (n = 175 women)…

  13. Comparing surgical repair with conservative treatment for degenerative rotator cuff tears : a randomized controlled trial

    NARCIS (Netherlands)

    Lambers Heerspink, Okke; van Raay, Jos J. A. M.; Koorevaar, Rinco C. T.; van Eerden, Pepijn J. M.; Westerbeek, Robin E.; van 't Riet, Esther; van den Akker-Scheek, Inge; Diercks, Ronald L.

    2015-01-01

    Background: Good clinical results have been reported for both surgical and conservative treatment of rotator cuff tears. The primary aim of this randomized controlled trial was to compare functional and radiologic improvement after surgical and conservative treatment of degenerative rotator cuff tea

  14. Randomized Trial of Internet-Delivered Self-Help with Telephone Support for Pathological Gamblers

    Science.gov (United States)

    Carlbring, Per; Smit, Filip

    2008-01-01

    Although effective therapies for pathological gambling exist, their uptake is limited to 10% of the target population. To lower the barriers for help seeking, the authors tested an online alternative in a randomized trial (N = 66). The participants were pathological gamblers not presenting with severe comorbid depression. A wait-list control was…

  15. Randomized Trial of Anger Control Training for Adolescents with Tourette's Syndrome and Disruptive Behavior

    Science.gov (United States)

    Sukhdolsky, Denis G.; Vitulano, Lawrence A.; Carroll, Deirdre H.; McGuire, Joseph; Leckman, James F.; Scahill, Lawrence

    2009-01-01

    A randomized trial to examine the efficacy of anger control training for treating adolescents with Tourette's syndrome and disruptive behavior reveals that those administered with the anger control training showed a decrease in their Disruptive Behavior Rating Scale score by 52 percent as compared with a decrease of 11 percent in the treatment as…

  16. Misoprostol versus curettage in women with early pregnancy failure after initial expectant management : a randomized trial

    NARCIS (Netherlands)

    Graziosi, GCM; Mol, BWJ; Reuwer, PJH; Drogtrop, A; Bruinse, HW

    2004-01-01

    BACKGROUND: Little is known about the effectiveness of misoprostol treatment in women with early pregnancy failure who have been managed expectantly. We therefore performed a randomized trial on this subject. METHODS: Women with early pregnancy failure, who had been managed expectantly for at least

  17. A Randomized Effectiveness Trial of Brief Parent Training: Six-Month Follow-Up

    Science.gov (United States)

    Kjøbli, John; Bjørnebekk, Gunnar

    2013-01-01

    Objective: To examine the follow-up effectiveness of brief parent training (BPT) for children with emerging or existing conduct problems. Method: With the use of a randomized controlled trial and parent and teacher reports, this study examined the effectiveness of BPT compared to regular services 6 months after the end of the intervention.…

  18. Parent Training for Young Children with Developmental Disabilities: Randomized Controlled Trial

    Science.gov (United States)

    McIntyre, Laura Lee

    2008-01-01

    A randomized controlled trial was used to evaluate a parent training intervention for caregivers with preschool-age children with developmental disabilities. The 21 families in the experimental group received usual care plus the 12-week Incredible Years Parent Training Program with developmental delay modifications. Families in the control group…

  19. Effectiveness of a Parent Training Program in (Pre)Adolescence: Evidence from a Randomized Controlled Trial

    Science.gov (United States)

    Leijten, Patty; Overbeek, Geertjan; Janssens, Jan M. A. M.

    2012-01-01

    The present randomized controlled trial examined the effectiveness of the parent training program Parents and Children Talking Together (PCTT) for parents with children in the preadolescent period who experience parenting difficulties. The program is focused on reducing child problem behavior by improving parents' communication and problem solving…

  20. Fit 5 Kids TV reduction program for Latino preschoolers: A cluster randomized controlled trial

    Science.gov (United States)

    Reducing Latino preschoolers' TV viewing is needed to reduce their risk of obesity and other chronic diseases. This study's objective was to evaluate the Fit 5 Kids (F5K) TV reduction program's impact on Latino preschooler's TV viewing. The study design was a cluster randomized controlled trial (RCT...

  1. PAIS: paracetamol (acetaminophen) in stroke; protocol for a randomized, double blind clinical trial [ISCRTN 74418480].

    NARCIS (Netherlands)

    E.J. van Breda (Eric); H.B. van der Worp (Bart); H.M.A. van Gemert (Maarten); A. Algra (Ale); L.J. Kappelle (Jaap); J. van Gijn (Jan); P.J. Koudstaal (Peter Jan); D.W.J. Dippel (Diederik)

    2005-01-01

    textabstractBACKGROUND: In patients with acute stroke, increased body temperature is associated with large lesion volumes, high case fatality, and poor functional outcome. A 1 degrees C increase in body temperature may double the odds of poor outcome. Two randomized double-blind clinical trials in p

  2. Starting insulin in type 2 diabetes : Continue oral hypoglycemic agents? A randomized trial in primary care

    NARCIS (Netherlands)

    Goudswaard, AN; Stolk, RP; Zuithoff, P; de Valk, HW; Rutten, GE

    2004-01-01

    Objective To evaluate the effects of insulin 30/70 twice daily or bedtime isophane (NPH) insulin plus continued sulfonylurea and metformin in patients with type 2 diabetes in primary care. Study Design Open-label, randomized trial. Population Persons younger than 76 years with type 2 diabetes whose

  3. Methylprednisolone in the management of spinal cord injuries: Lessons from randomized, controlled trials

    Directory of Open Access Journals (Sweden)

    Vincent Cheung

    2015-01-01

    Full Text Available The efficacy of glucocorticoid for treatment of acute spinal cord injuries remains a controversial topic. Differing medical societies have issued conflicting recommendations in this regard. Here we review the available randomized, controlled trial (RCT data on this subject and offer a synthesis of these data sets.

  4. Randomized trial of two swallowing assessment approaches in patients with acquired brain injury

    DEFF Research Database (Denmark)

    Kjaersgaard, Annette; Nielsen, Lars Hedemann; Sjölund, Bengt H.

    2014-01-01

    trial. SETTING: Specialized, national neurorehabilitation centre. SUBJECTS: Adult patients with acquired brain injury. Six hundred and seventy-nine patients were assessed for eligibility and 138 were randomly allocated between June 2009 and April 2011. INTERVENTIONS: Assessment by Facial-Oral Tract...

  5. 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…

  6. Randomized, Controlled Trial to Examine the Impact of Providing Yogurt to Women Enrolled in WIC

    Science.gov (United States)

    Fung, Ellen B.; Ritchie, Lorrene D.; Walker, Brent H.; Gildengorin, Ginny; Crawford, Patricia B.

    2010-01-01

    Objective: Examine the impact of providing yogurt to women enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Design: Randomized, controlled intervention trial. Setting: Two California WIC local agency sites. Participants: 511 pregnant, breast-feeding, or postpartum women. Intervention: Substitution of…

  7. 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

    for unblinding was perceptible physical properties of the treatments, for example, a difference in the taste and odor of a typhoid vaccine compared with its placebo. CONCLUSION: Published articles on randomized clinical trials infrequently reported risk of unblinding. This may reflect a tendency for avoiding...

  8. Randomized Trial of the Effect of Contact Lens Wear on Self-Perception in Children

    NARCIS (Netherlands)

    Walline, J.J.; Jones, L.A.; Sinnott, L.; Chitkara, M.; Coffey, B.; Jackson, J.M.; Manny, R.E.; Rath, M.J.; Prinstein, M.J.

    2009-01-01

    Purpose. To determine whether contact lens wear affects children's self-perceptions. Methods. The Adolescent and Child Health Initiative to Encourage Vision Empowerment Study was a randomized, single-masked trial conducted at five clinical centers in the United States. Subjects were 8- to 11-year-ol

  9. Modified Constraint-Induced Therapy for Children with Hemiplegic Cerebral Palsy: A Randomized Trial

    Science.gov (United States)

    Wallen, Margaret; Ziviani, Jenny; Naylor, Olivia; Evans, Ruth; Novak, Iona; Herbert, Robert D.

    2011-01-01

    Aim: Conventional constraint-based therapies are intensive and demanding to implement, particularly for children. Modified forms of constraint-based therapies that are family-centred may be more acceptable and feasible for families of children with cerebral palsy (CP)-but require rigorous evaluation using randomized trials. The aim of this study…

  10. Physical activity, mindfulness meditation, or heart rate variability biofeedback for stress reduction: a randomized controlled trial

    NARCIS (Netherlands)

    J.E. van der Zwan; W. de Vente; A.C. Huizink; S.M. Bögels; E.I. de Bruin

    2015-01-01

    In contemporary western societies stress is highly prevalent, therefore the need for stress-reducing methods is great. This randomized controlled trial compared the efficacy of self-help physical activity (PA), mindfulness meditation (MM), and heart rate variability biofeedback (HRV-BF) in reducing

  11. A Randomized Trial of a Multimodal Community-Based Prisoner Reentry Program Emphasizing Substance Abuse Treatment

    Science.gov (United States)

    Grommon, Eric; Davidson, William S., II; Bynum, Timothy S.

    2013-01-01

    Prisoner reentry programs continue to be developed and implemented to ease the process of transition into the community and to curtail fiscal pressures. This study describes and provides relapse and recidivism outcome findings related to a randomized trial evaluating a multimodal, community-based reentry program that prioritized substance abuse…

  12. Acupuncture for Children with Autism Spectrum Disorders: A Systematic Review of Randomized Clinical Trials

    Science.gov (United States)

    Lee, Myeong Soo; Choi, Tae-Young; Shin, Byung-Cheul; Ernst, Edzard

    2012-01-01

    This study aimed to assess the effectiveness of acupuncture as a treatment for autism spectrum disorders (ASD). We searched the literature using 15 databases. Eleven randomized clinical trials (RCTs) met our inclusion criteria. Most had significant methodological weaknesses. The studies' statistical and clinical heterogeneity prevented us from…

  13. Assessment of risk of bias in randomized clinical trials in surgery

    DEFF Research Database (Denmark)

    Gurusamy, K S; Gluud, C; Nikolova, D;

    2009-01-01

    BACKGROUND: Meta-analysis of randomized clinical trials (RCTs) with low risk of bias is considered the highest level of evidence available for evaluating an intervention. Bias in RCTs may overestimate or underestimate the true effectiveness of an intervention. METHODS: The causes of bias...

  14. A Randomized Trial of Wraparound Facilitation versus Usual Child Protection Services

    Science.gov (United States)

    Browne, Dillon T.; Puente-Duran, Sofia; Shlonsky, Aron; Thabane, Lehana; Verticchio, Dominic

    2016-01-01

    Objective: To evaluate whether the addition of a wraparound facilitator to regular child protection services improved child and family functioning over 20 months. Method: A single blind randomized controlled trial with concealment and stratification across three sites (N = 135 eligible families with substantiated maltreatment). Results: Based on 2…

  15. Stepped care vs. matched care for mood and anxiety disorders : a randomized trial in routine practice

    NARCIS (Netherlands)

    van Straten, A; Tiemens, B; Hakkaart, L; Nolen, WA; Donker, MCH

    2006-01-01

    Objective: The effectiveness of two versions of stepped care [with either brief therapy (BT) or cognitive behavioural therapy (CBT) as a first step] is studied in comparison with the traditional matched care approach (CAU) for patients with mood and anxiety disorders. Method: A randomized trial was

  16. The Efficiency and Efficacy of Equivalence-Based Learning: A Randomized Controlled Trial

    Science.gov (United States)

    Zinn, Tracy E.; Newland, M. Christopher; Ritchie, Katie E.

    2015-01-01

    Because it employs an emergent-learning framework, equivalence-based instruction (EBI) is said to be highly efficient, but its presumed benefits must be compared quantitatively with alternative techniques. In a randomized controlled trial, 61 college students attempted to learn 32 pairs of proprietary and generic drug names using computer-based…

  17. The Anatomy of Failure : An Ethnography of a Randomized Trial to Deepen Democracy in Rural India

    OpenAIRE

    Ananthpur, Kripa; Malik, Kabir; Rao, Vijayendra

    2014-01-01

    Programs that induce citizen participation to improve the quality of government at the local level are the subjects of large amounts of funding and intense debate. This paper combines a randomized control trial of a citizenship training and facilitation program in rural India, with an in-depth, four-year ethnography of the intervention to understand the underlying mechanisms of change. The...

  18. Computerized Training of Working Memory in Children with ADHD-A Randomized, Controlled Trial

    Science.gov (United States)

    Klingberg, Torkel; Fernell, Elisabeth; Olesen, Pernille J.; Johnson, Mats; Gustafsson, Per; Dahlstrom, Kerstin; Gillberg, Christopher G.; Forssberg, Hans; Westerberg, Helena

    2005-01-01

    Objective: Deficits in executive functioning, including working memory (WM) deficits, have been suggested to be important in attention-deficit/hyperactivity disorder (ADHD). During 2002 to 2003, the authors conducted a multicenter, randomized, controlled, double-blind trial to investigate the effect of improving WM by computerized, systematic…

  19. A Randomized Clinical Trial of Alternative Stress Management Interventions in Persons with HIV Infection

    Science.gov (United States)

    McCain, Nancy L.; Gray, D. Patricia; Elswick, R. K., Jr.; Robins, Jolynne W.; Tuck, Inez; Walter, Jeanne M.; Rausch, Sarah M.; Ketchum, Jessica McKinney

    2008-01-01

    Research in psychoneuroimmunology suggests that immunosuppression associated with perceived stress may contribute to disease progression in persons with HIV infection. While stress management interventions may enhance immune function, few alternative approaches have yet been tested. This randomized clinical trial was conducted to test effects of…

  20. A randomized controlled trial of orbital radiotherapy versus sham irradiation in patients with mild Graves' ophthalmopathy

    NARCIS (Netherlands)

    Prummel, MF; Terwee, CB; Gerding, MN; Baldeschi, L; Mourits, MP; Blank, L; Dekker, FW; Wiersinga, WM

    2004-01-01

    Radiotherapy is often used in Graves' ophthalmopathy, but its efficacy has been doubted. We compared its efficacy with sham irradiation in mild ophthalmopathy. In a double-blind randomized trial, 44 patients received orbital irradiation, and 44 were sham-irradiated. The primary outcome was assessed

  1. Interpretation Training in Individuals with Generalized Social Anxiety Disorder: A Randomized Controlled Trial

    Science.gov (United States)

    Amir, Nader; Taylor, Charles T.

    2012-01-01

    Objective: To examine the efficacy of a multisession computerized interpretation modification program (IMP) in the treatment of generalized social anxiety disorder (GSAD). Method: The sample comprised 49 individuals meeting diagnostic criteria for GSAD who were enrolled in a randomized, double-blind placebo-controlled trial comparing IMP (n = 23)…

  2. The effectiveness of integrated care for patients with hand eczema: Results of a randomized, controlled trial

    NARCIS (Netherlands)

    Gils, R.F. van; Boot, C.R.L.; Knol, D.L.; Rustemeyer, T.; Mechelen, W. van; Valk, P.G.M. van der; Anema, J.R.

    2012-01-01

    Objectives. To evaluate the effectiveness of integrated, multidisciplinary care as compared with usual care for patients with moderate to severe, chronic hand eczema after 26 weeks of follow-up. Background. This study was designed as a randomized, controlled trial. Methods. Patients who visited one

  3. Multisite Randomized Controlled Trial Examining Intelligent Tutoring of Structure Strategy for Fifth-Grade Readers

    Science.gov (United States)

    Wijekumar, Kausalai; Meyer, Bonnie J. F.; Lei, Pui-Wa; Lin, Yu-Chu; Johnson, Lori A.; Spielvogel, James A.; Shurmatz, Kathryn M.; Ray, Melissa; Cook, Michael

    2014-01-01

    This article reports on a large scale randomized controlled trial to study the efficacy of a web-based intelligent tutoring system for the structure strategy designed to improve content area reading comprehension. The research was conducted with 128 fifth-grade classrooms within 12 school districts in rural and suburban settings. Classrooms within…

  4. Moving from Efficacy to Effectiveness in Cognitive Behavioral Therapy for Psychosis: A Randomized Clinical Practice Trial

    Science.gov (United States)

    Lincoln, Tania M.; Ziegler, Michael; Mehl, Stephanie; Kesting, Marie-Luise; Lullmann, Eva; Westermann, Stefan; Rief, Winfried

    2012-01-01

    Objective: Randomized controlled trials have attested the efficacy of cognitive behavioral therapy (CBT) in reducing psychotic symptoms. Now, studies are needed to investigate its effectiveness in routine clinical practice settings. Method: Eighty patients with schizophrenia spectrum disorders who were seeking outpatient treatment were randomized…

  5. Effect of fish oil on cognitive performance in older subjects: a randomized, controlled trial.

    NARCIS (Netherlands)

    Rest, O van de; Geleijnse, J.M.; Kok, F.J.; Staveren, W.A. van; Dullemeijer, C.; Olderikkert, M.G.; Beekman, A.T.; Groot, CP de

    2008-01-01

    BACKGROUND: High intake of n-3 polyunsaturated fatty acids may protect against age-related cognitive decline. However, results from epidemiologic studies are inconclusive, and results from randomized trials in elderly subjects without dementia are lacking. OBJECTIVE: To investigate the effect of eic

  6. Effect of fish oil on cognitive performance in older subjects: a randomized, controlled trial

    NARCIS (Netherlands)

    Rest, van de O.; Geleijnse, J.M.; Kok, F.J.; Staveren, van W.A.; Dullemeijer, C.; OldeRikkert, M.G.M.; Beekman, A.T.F.; Groot, de C.P.G.M.

    2008-01-01

    Background: High intake of n-3 polyunsaturated fatty acids may protect against age-related cognitive decline. However, results from epidemiologic studies are inconclusive, and results from randomized trials in elderly subjects without dementia are lacking. Objective: To investigate the effect of eic

  7. Sedation and renal impairment in critically ill patients: a post hoc analysis of a randomized trial

    DEFF Research Database (Denmark)

    Strøm, Thomas; Johansen, Rasmus R.; Prahl, Jens O;

    2011-01-01

    need for vasoactive drugs, diminishes the need for extra fluids and lowers the risk of acute kidney injury. METHODS: We performed an evaluation on the database from our previous trial of 140 patients randomized to either no sedation vs. sedation with a daily interruption of sedatives (Clinical...

  8. Effects of Assertiveness Training and Expressive Writing on Acculturative Stress in International Students: A Randomized Trial

    Science.gov (United States)

    Tavakoli, Shedeh; Lumley, Mark A.; Hijazi, Alaa M.; Slavin-Spenny, Olga M.; Parris, George P.

    2009-01-01

    International university students often experience acculturative stress, and culturally appropriate techniques to manage stress are needed. This randomized trial tested the effects of group assertiveness training, private expressive writing, their combination, and a wait-list control on the acculturative stress, affect, and health of 118…

  9. Monthly high dose vitamin D treatment for the prevention of functional decline: a randomized clinical trial

    Science.gov (United States)

    Importance: Vitamin D deficiency has been associated with poor physical performance. Objective: To determine the effectiveness of high dose vitamin D in lowering the risk of functional decline. Design, Setting, and Participants: One-year double-blind, randomized clinical trial conducted in Zurich,...

  10. Randomized clinical trial of self-gripping mesh versus sutured mesh for Lichtenstein hernia repair

    DEFF Research Database (Denmark)

    Jorgensen, L N; Sommer, T; Assaadzadeh, S;

    2012-01-01

    BACKGROUND: Many patients develop discomfort after open repair of a groin hernia. It was hypothesized that suture fixation of the mesh is a cause of these symptoms. METHODS: This patient- and assessor-blinded randomized multicentre clinical trial compared a self-gripping mesh (Parietene Progrip...

  11. Competitive Employment for Youth with Autism Spectrum Disorders: Early Results from a Randomized Clinical Trial

    Science.gov (United States)

    Wehman, Paul H.; Schall, Carol M.; McDonough, Jennifer; Kregel, John; Brooke, Valerie; Molinelli, Alissa; Ham, Whitney; Graham, Carolyn W.; Riehle, J. Erin; Collins, Holly T.; Thiss, Weston

    2014-01-01

    For most youth with autism spectrum disorders (ASD), employment upon graduation from high school or college is elusive. Employment rates are reported in many studies to be very low despite many years of intensive special education services. This paper presented the preliminary results of a randomized clinical trial of Project SEARCH plus ASD…

  12. Enhancing Attachment Organization among Maltreated Children: Results of a Randomized Clinical Trial

    Science.gov (United States)

    Bernard, Kristin; Dozier, Mary; Bick, Johanna; Lewis-Morrarty, Erin; Lindhiem, Oliver; Carlson, Elizabeth

    2012-01-01

    Young children who have experienced early adversity are at risk for developing disorganized attachments. The efficacy of Attachment and Biobehavioral Catch-up (ABC), an intervention targeting nurturing care among parents identified as being at risk for neglecting their young children, was evaluated through a randomized clinical trial. Attachment…

  13. Positive Family Intervention for Severe Challenging Behavior I: A Multisite Randomized Clinical Trial

    Science.gov (United States)

    Durand, V. Mark; Hieneman, Meme; Clarke, Shelley; Wang, Mo; Rinaldi, Melissa L.

    2013-01-01

    The present study was a multisite randomized clinical trial assessing the effects of adding a cognitive-behavioral intervention to positive behavior support (PBS). Fifty-four families who met the criteria of (a) having a child with a developmental disability, (b) whose child displayed serious challenging behavior (e.g., aggression, self-injury,…

  14. Educational Effects of the Tools of the Mind Curriculum: A Randomized Trial

    Science.gov (United States)

    Barnett, W.Steven; Jung, Kwanghee; Yarosz, Donald J.; Thomas, Jessica; Hornbeck, Amy; Stechuk, Robert; Burns, Susan

    2008-01-01

    The effectiveness of the "Tools of the Mind (Tools)" curriculum in improving the education of 3- and 4-year-old children was evaluated by means of a randomized trial. The "Tools" curriculum, based on the work of Vygotsky, focuses on the development of self-regulation at the same time as teaching literacy and mathematics skills in a way that is…

  15. Reconsidering Findings of "No Effects" in Randomized Control Trials: Modeling Differences in Treatment Impacts

    Science.gov (United States)

    Chaney, Bradford

    2016-01-01

    The primary technique that many researchers use to analyze data from randomized control trials (RCTs)--detecting the average treatment effect (ATE)--imposes assumptions upon the data that often are not correct. Both theory and past research suggest that treatments may have significant impacts on subgroups even when showing no overall effect.…

  16. Big data: Are large prospective randomized trials obsolete in the future?

    Science.gov (United States)

    Hudis, Clifford A

    2015-11-01

    Big data represents a new opportunity to increase our understanding of cancer care as it is practiced globally and to improve it through the refinement of clinic guidelines and the identification of knowledge gaps. Here we review the historical approach to evidence development (randomized clinical trials), some of their limitations, and the complementary role that big data analytics may play.

  17. Event Rates in Randomized Clinical Trials Evaluating Cardiovascular Interventions and Devices

    NARCIS (Netherlands)

    Mahmoud, Karim D.; Lennon, Ryan J.; Holmes, David R.

    2015-01-01

    Randomized clinical trials (RCTs) are considered the gold standard for evidence-based medicine. However, an accurate estimation of the event rate is crucial for their ability to test clinical hypotheses. Overestimation of event rates reduces the required sample size but can compromise the statistica

  18. A Randomized Trial of a Multifaceted Intervention to Reduce Falls among Community-Dwelling Adults

    Science.gov (United States)

    Fox, Patrick J.; Vazquez, Laurie; Tonner, Chris; Stevens, Judy A.; Fineman, Norman; Ross, Leslie K.

    2010-01-01

    Using a randomized controlled trial, we tested the efficacy of a fall prevention intervention to reduce falls among adults in a community-based health promotion program. Adults aged 65 and older within two counties were recruited (control n = 257; intervention n = 286). After 12 months, there was a significant decrease in the number of falls in…

  19. Escitalopram in the Treatment of Adolescent Depression: A Randomized Placebo-Controlled Multisite Trial

    Science.gov (United States)

    Emslie, Graham J.; Ventura, Daniel; Korotzer, Andrew; Tourkodimitris, Stavros

    2009-01-01

    A randomized, double-blind, placebo-controlled trial that involves 312 male and female patients aged 12-17 reveal the effectiveness of escitalopram in the treatment of depressed adolescents. Eighty-three percent of the participants or 259 participants completed the 8 weeks therapy period.

  20. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial.

    LENUS (Irish Health Repository)

    McDonnell, John G

    2008-01-01

    The transversus abdominis plane (TAP) block is an effective method of providing postoperative analgesia in patients undergoing midline abdominal wall incisions. We evaluated its analgesic efficacy over the first 48 postoperative hours after cesarean delivery performed through a Pfannensteil incision, in a randomized controlled, double-blind, clinical trial.

  1. A randomized trial of treatment for acute anterior cruciate ligament tears

    DEFF Research Database (Denmark)

    Frobell, Richard B; Roos, Ewa M; Roos, Harald P;

    2010-01-01

    BACKGROUND: The optimal management of a torn anterior cruciate ligament (ACL) of the knee is unknown. METHODS: We conducted a randomized, controlled trial involving 121 young, active adults with acute ACL injury in which we compared two strategies: structured rehabilitation plus early ACL...

  2. Randomized Controlled Trial of a Family Cognitive-Behavioral Preventive Intervention for Children of Depressed Parents

    Science.gov (United States)

    Compas, Bruce E.; Forehand, Rex; Keller, Gary; Champion, Jennifer E.; Rakow, Aaron; Reeslund, Kristen L.; McKee, Laura; Fear, Jessica M.; Colletti, Christina J. M.; Hardcastle, Emily; Merchant, Mary Jane; Roberts, Lori; Potts, Jennifer; Garai, Emily; Coffelt, Nicole; Roland, Erin; Sterba, Sonya K.; Cole, David A.

    2009-01-01

    A family cognitive-behavioral preventive intervention for parents with a history of depression and their 9-15-year-old children was compared with a self-study written information condition in a randomized clinical trial (n = 111 families). Outcomes were assessed at post-intervention (2 months), after completion of 4 monthly booster sessions (6…

  3. Treatment success in cancer: industry compared to publicly sponsored randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Benjamin Djulbegovic

    Full Text Available OBJECTIVE: To assess if commercially sponsored trials are associated with higher success rates than publicly-sponsored trials. STUDY DESIGN AND SETTINGS: We undertook a systematic review of all consecutive, published and unpublished phase III cancer randomized controlled trials (RCTs conducted by GlaxoSmithKline (GSK and the NCIC Clinical Trials Group (CTG. We included all phase III cancer RCTs assessing treatment superiority from 1980 to 2010. Three metrics were assessed to determine treatment successes: (1 the proportion of statistically significant trials favouring the experimental treatment, (2 the proportion of the trials in which new treatments were considered superior according to the investigators, and (3 quantitative synthesis of data for primary outcomes as defined in each trial. RESULTS: GSK conducted 40 cancer RCTs accruing 19,889 patients and CTG conducted 77 trials enrolling 33,260 patients. 42% (99%CI 24 to 60 of the results were statistically significant favouring experimental treatments in GSK compared to 25% (99%CI 13 to 37 in the CTG cohort (RR = 1.68; p = 0.04. Investigators concluded that new treatments were superior to standard treatments in 80% of GSK compared to 44% of CTG trials (RR = 1.81; p<0.001. Meta-analysis of the primary outcome indicated larger effects in GSK trials (odds ratio = 0.61 [99%CI 0.47-0.78] compared to 0.86 [0.74-1.00]; p = 0.003. However, testing for the effect of treatment over time indicated that treatment success has become comparable in the last decade. CONCLUSIONS: While overall industry sponsorship is associated with higher success rates than publicly-sponsored trials, the difference seems to have disappeared over time.

  4. 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.

  5. Study designs of randomized controlled trials not based on Chinese medicine theory are improper

    Directory of Open Access Journals (Sweden)

    Jiao Yan

    2009-02-01

    Full Text Available Abstract Current biomedical research methods to evaluate the efficacy of Chinese medicine interventions are often conceptually incompatible with the theory and clinical practice of Chinese medicine. In this commentary, we (1 highlight the theory and principles underlying Chinese medicine clinical practice; (2 use ginseng as an example to describe clinical indications in Chinese medicine; (3 propose a framework guided by Chinese medicine theory for the evaluation of study designs in Chinese medicine research; and (4 evaluate 19 randomized, double-blind, placebo-controlled trials of ginseng. Our analysis indicates that all 19 trials with both positive and negative results confirm the specific effects of ginseng indicated by Chinese medicine theory. Study designs guided by Chinese medicine theory are necessary to validate and improve future randomized controlled clinical trials in Chinese medicine.

  6. Estimating optimal treatment regimes via subgroup identification in randomized control trials and observational studies.

    Science.gov (United States)

    Fu, Haoda; Zhou, Jin; Faries, Douglas E

    2016-08-30

    With new treatments and novel technology available, personalized medicine has become an important piece in the new era of medical product development. Traditional statistics methods for personalized medicine and subgroup identification primarily focus on single treatment or two arm randomized control trials. Motivated by the recent development of outcome weighted learning framework, we propose an alternative algorithm to search treatment assignments which has a connection with subgroup identification problems. Our method focuses on applications from clinical trials to generate easy to interpret results. This framework is able to handle two or more than two treatments from both randomized control trials and observational studies. We implement our algorithm in C++ and connect it with R. Its performance is evaluated by simulations, and we apply our method to a dataset from a diabetes study. Copyright © 2016 John Wiley & Sons, Ltd. PMID:26892174

  7. Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics.

    Science.gov (United States)

    Van Poucke, Sven; Thomeer, Michiel; Heath, John; Vukicevic, Milan

    2016-01-01

    Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers' scientific epistemology of "falsificationism." Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation. PMID:27383622

  8. Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics.

    Science.gov (United States)

    Van Poucke, Sven; Thomeer, Michiel; Heath, John; Vukicevic, Milan

    2016-07-06

    Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers' scientific epistemology of "falsificationism." Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation.

  9. Pre-randomization decisions and group stratification in a randomized controlled trial to improve prescribing

    NARCIS (Netherlands)

    van Eijk, Martine E C; Paes, Arsenio H P; Porsius, Arijan; Avorn, Jerry; de Boer, Anthonius

    2004-01-01

    OBJECTIVE: To select and evaluate characteristics of primary care practice groups relevant for stratification prior to randomization. METHOD: Structured telephone interviews and pre- and post-intervention prescription data. SETTING: Additional study in an RCT to rationalize prescribing in primary ca

  10. Whose data set is it anyway? Sharing raw data from randomized trials

    Directory of Open Access Journals (Sweden)

    Vickers Andrew J

    2006-05-01

    Full Text Available Abstract Background Sharing of raw research data is common in many areas of medical research, genomics being perhaps the most well-known example. In the clinical trial community investigators routinely refuse to share raw data from a randomized trial without giving a reason. Discussion Data sharing benefits numerous research-related activities: reproducing analyses; testing secondary hypotheses; developing and evaluating novel statistical methods; teaching; aiding design of future trials; meta-analysis; and, possibly, preventing error, fraud and selective reporting. Clinical trialists, however, sometimes appear overly concerned with being scooped and with misrepresentation of their work. Both possibilities can be avoided with simple measures such as inclusion of the original trialists as co-authors on any publication resulting from data sharing. Moreover, if we treat any data set as belonging to the patients who comprise it, rather than the investigators, such concerns fall away. Conclusion Technological developments, particularly the Internet, have made data sharing generally a trivial logistical problem. Data sharing should come to be seen as an inherent part of conducting a randomized trial, similar to the way in which we consider ethical review and publication of study results. Journals and funding bodies should insist that trialists make raw data available, for example, by publishing data on the Web. If the clinical trial community continues to fail with respect to data sharing, we will only strengthen the public perception that we do clinical trials to benefit ourselves, not our patients.

  11. Effects of unstratified and centre-stratified randomization in multi-centre clinical trials.

    Science.gov (United States)

    Anisimov, Vladimir V

    2011-01-01

    This paper deals with the analysis of randomization effects in multi-centre clinical trials. The two randomization schemes most often used in clinical trials are considered: unstratified and centre-stratified block-permuted randomization. The prediction of the number of patients randomized to different treatment arms in different regions during the recruitment period accounting for the stochastic nature of the recruitment and effects of multiple centres is investigated. A new analytic approach using a Poisson-gamma patient recruitment model (patients arrive at different centres according to Poisson processes with rates sampled from a gamma distributed population) and its further extensions is proposed. Closed-form expressions for corresponding distributions of the predicted number of the patients randomized in different regions are derived. In the case of two treatments, the properties of the total imbalance in the number of patients on treatment arms caused by using centre-stratified randomization are investigated and for a large number of centres a normal approximation of imbalance is proved. The impact of imbalance on the power of the study is considered. It is shown that the loss of statistical power is practically negligible and can be compensated by a minor increase in sample size. The influence of patient dropout is also investigated. The impact of randomization on predicted drug supply overage is discussed.

  12. A cluster randomized trial evaluating electronic prescribing in an ambulatory care setting

    Directory of Open Access Journals (Sweden)

    Quan Sherman

    2007-10-01

    Full Text Available Abstract Background Medication errors, adverse drug events and potential adverse drug events are common and serious in terms of the harms and costs that they impose on the health system and those who use it. Errors resulting in preventable adverse drug events have been shown to occur most often at the stages of ordering and administration. This paper describes the protocol for a pragmatic trial of electronic prescribing to reduce prescription error. The trial was designed to overcome the limitations associated with traditional study design. Design This study was designed as a 65-week, cluster randomized, parallel study. Methods The trial was conducted within ambulatory outpatient clinics in an academic tertiary care centre in Ontario, Canada. The electronic prescribing software for the study is a Canadian electronic prescribing software package which provides physician prescription entry with decision support at the point of care. Using a handheld computer (PDA the physician selects medications using an error minimising menu-based pick list from a comprehensive drug database, create specific prescription instructions and then transmit the prescription directly and electronically to a participating pharmacy via facsimile or to the physician's printer using local area wireless technology. The unit of allocation and randomization is by 'week', i.e. the system is "on" or "off" according to the randomization scheme and the unit of analysis is the prescription, with adjustment for clustering of patients within practitioners. Discussion This paper describes the protocol for a pragmatic cluster randomized trial of point-of-care electronic prescribing, which was specifically designed to overcome the limitations associated with traditional study design. Trial Registration This trial has been registered with clinicaltrials.gov (ID: NCT00252395

  13. Antibiotic selection pressure and macrolide resistance in nasopharyngeal Streptococcus pneumoniae: a cluster-randomized clinical trial.

    Directory of Open Access Journals (Sweden)

    Alison H Skalet

    Full Text Available BACKGROUND: It is widely thought that widespread antibiotic use selects for community antibiotic resistance, though this has been difficult to prove in the setting of a community-randomized clinical trial. In this study, we used a randomized clinical trial design to assess whether macrolide resistance was higher in communities treated with mass azithromycin for trachoma, compared to untreated control communities. METHODS AND FINDINGS: In a cluster-randomized trial for trachoma control in Ethiopia, 12 communities were randomized to receive mass azithromycin treatment of children aged 1-10 years at months 0, 3, 6, and 9. Twelve control communities were randomized to receive no antibiotic treatments until the conclusion of the study. Nasopharyngeal swabs were collected from randomly selected children in the treated group at baseline and month 12, and in the control group at month 12. Antibiotic susceptibility testing was performed on Streptococcus pneumoniae isolated from the swabs using Etest strips. In the treated group, the mean prevalence of azithromycin resistance among all monitored children increased from 3.6% (95% confidence interval [CI] 0.8%-8.9% at baseline, to 46.9% (37.5%-57.5% at month 12 (p = 0.003. In control communities, azithromycin resistance was 9.2% (95% CI 6.7%-13.3% at month 12, significantly lower than the treated group (p < 0.0001. Penicillin resistance was identified in 0.8% (95% CI 0%-4.2% of isolates in the control group at 1 year, and in no isolates in the children-treated group at baseline or 1 year. CONCLUSIONS: This cluster-randomized clinical trial demonstrated that compared to untreated control communities, nasopharyngeal pneumococcal resistance to macrolides was significantly higher in communities randomized to intensive azithromycin treatment. Mass azithromycin distributions were given more frequently than currently recommended by the World Health Organization's trachoma program. Azithromycin use in this setting

  14. Does mass azithromycin distribution impact child growth and nutrition in Niger? A cluster-randomized trial.

    Directory of Open Access Journals (Sweden)

    Abdou Amza

    2014-09-01

    Full Text Available Antibiotic use on animals demonstrates improved growth regardless of whether or not there is clinical evidence of infectious disease. Antibiotics used for trachoma control may play an unintended benefit of improving child growth.In this sub-study of a larger randomized controlled trial, we assess anthropometry of pre-school children in a community-randomized trial of mass oral azithromycin distributions for trachoma in Niger. We measured height, weight, and mid-upper arm circumference (MUAC in 12 communities randomized to receive annual mass azithromycin treatment of everyone versus 12 communities randomized to receive biannual mass azithromycin treatments for children, 3 years after the initial mass treatment. We collected measurements in 1,034 children aged 6-60 months of age.We found no difference in the prevalence of wasting among children in the 12 annually treated communities that received three mass azithromycin distributions compared to the 12 biannually treated communities that received six mass azithromycin distributions (odds ratio = 0.88, 95% confidence interval = 0.53 to 1.49.We were unable to demonstrate a statistically significant difference in stunting, underweight, and low MUAC of pre-school children in communities randomized to annual mass azithromycin treatment or biannual mass azithromycin treatment. The role of antibiotics on child growth and nutrition remains unclear, but larger studies and longitudinal trials may help determine any association.

  15. 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

  16. 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

  17. Randomized trials, generalizability, and meta-analysis: Graphical insights for binary outcomes

    Directory of Open Access Journals (Sweden)

    Kramer Barnett S

    2003-06-01

    Full Text Available Abstract Background Randomized trials stochastically answer the question. "What would be the effect of treatment on outcome if one turned back the clock and switched treatments in the given population?" Generalizations to other subjects are reliable only if the particular trial is performed on a random sample of the target population. By considering an unobserved binary variable, we graphically investigate how randomized trials can also stochastically answer the question, "What would be the effect of treatment on outcome in a population with a possibly different distribution of an unobserved binary baseline variable that does not interact with treatment in its effect on outcome?" Method For three different outcome measures, absolute difference (DIF, relative risk (RR, and odds ratio (OR, we constructed a modified BK-Plot under the assumption that treatment has the same effect on outcome if either all or no subjects had a given level of the unobserved binary variable. (A BK-Plot shows the effect of an unobserved binary covariate on a binary outcome in two treatment groups; it was originally developed to explain Simpsons's paradox. Results For DIF and RR, but not OR, the BK-Plot shows that the estimated treatment effect is invariant to the fraction of subjects with an unobserved binary variable at a given level. Conclusion The BK-Plot provides a simple method to understand generalizability in randomized trials. Meta-analyses of randomized trials with a binary outcome that are based on DIF or RR, but not OR, will avoid bias from an unobserved covariate that does not interact with treatment in its effect on outcome.

  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. Intravenous chemotherapy for resected gastric cancer: meta-analysis of randomized controlled trials

    Institute of Scientific and Technical Information of China (English)

    Jian-Kun Hu; You-Ping Li; Zhi-Xin Chen; Zong-Guang Zhou; Bo Zhang; Jing Tian; Jia-Ping Chen; Li Wang; Chao-Hua Wang; Hong-Yan Chen

    2002-01-01

    AIM: To assess the safety and efficacy of different intravenous chemotherapeutic regimens in patients with gastric carcinomas who had undergone gastrectomy.METHODS: A meta-analysis of all the relevant randomized controlled trials (RCTs) was performed. Language was restricted to Chinese and English. RCTs were identified from Medline and Embase (1980-2001/4), and Chinese Biowere checked at the same time. We included randomized and quasi-randomized trials comparing the efficacy of intravenous chemotherapy after gastrectomy with that of surgery alone in patients with confirmed gastric carcinomas who had undergone gastrectomy. Selection criteria were: randomized or quasi-randomized trials with following-up results; Trials could be double-blind, single-blind or not blind; Chemotherapy groups were given intravenous chemotherapy after gastrectomy without neo-adjuvant chemotherapy, intraperitoneal hyperthermic perfusion, radiotherapy or chemoimmunotherapy; Controlled group included those receiving gastrectomy alone. The following data were extracted: the number of survival and death by the end of the follow-up; the different agents and doses of the intravenous chemotherapy; the baseline of the chemotherapy group and the controlled arm; the serious adverse events; the statistical consideration; cost-effectiveness analysis. The statistical analysis was performed by RevMan4.1 software which was provided by the Cochrane Collaboration. A Pvalue of <0.05 was considered statistically significant. Metaanalysis was done with random effects model. Heterogeneity was checked by chi-square test. Sensitivity analysis was performed by excluding the trials in which Jadad-scale was only 1 score. The result was expressed with odds ratio (OR) for the categorical variable.RESULTS: Fourteen trials involving 4543 patients were included. Meta-analysis was done with random effects model. Heterogeneity and sensitivity analysis were performed also. The effect of intravenous chemotherapy after

  20. Developing a survey of barriers and facilitators to recruitment in randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Kaur Geetinder

    2012-11-01

    Full Text Available Abstract Background Recruitment to randomized controlled trials is known to be challenging. It is important to understand and identify predictors of good or poor accrual to a clinical trial so that appropriate strategies can be put in place to overcome these problems and facilitate successful trial completion. We have developed a survey tool to establish the recruitment experience of clinical teams regarding facilitators and barriers to recruitment in a clinical trial and describe herein the method of developing the questionnaire. Methods A literature search was conducted to identify studies that have explored facilitators and barriers to recruitment, and a list of potential factors affecting recruitment to a clinical trial was generated. These factors were categorized in terms relating to the (i trial, (ii site, (iii patient, (iv clinical team, (v information and consent and (vi study team. A list was provided for responders to grade these factors as weak, intermediate or strong facilitators or barriers to recruitment. Results A web-based survey questionnaire was developed. This survey was designed to establish the recruitment experience of clinical teams with regard to the perceived facilitators and barriers to recruitment, to identify strategies applied to overcome these problems, and to obtain suggestions for change in the organization of future trials. The survey tool can be used to assess the recruitment experience of clinical teams in a single/multicenter trial in any clinical setting or speciality involving adults or children either in an ongoing trial or at trial completion. The questionnaire is short, easy to administer and to complete, with an estimated completion time of 11 minutes. Conclusions We have presented a robust methodology for developing this survey tool that provides an evidence-based list of potential factors that can affect recruitment to a clinical trial. We recommend that all clinical trialists should consider using

  1. Multicenter randomized trial of cell therapy in cardiopathies – MiHeart Study

    Science.gov (United States)

    Tura, Bernardo R; Martino, Helena F; Gowdak, Luis H; dos Santos, Ricardo Ribeiro; Dohmann, Hans F; Krieger, José E; Feitosa, Gilson; Vilas-Boas, Fábio; Oliveira, Sérgio A; Silva, Suzana A; Bozza, Augusto Z; Borojevic, Radovan; de Carvalho, Antonio C Campos

    2007-01-01

    Background Cardiovascular diseases are the major cause of death in the world. Current treatments have not been able to reverse this scenario, creating the need for the development of new therapies. Cell therapies have emerged as an alternative for cardiac diseases of distinct causes in experimental animal studies and more recently in clinical trials. Method/Design We have designed clinical trials to test for the efficacy of autologous bone marrow derived mononuclear cell therapies in four different cardiopathies: acute and chronic ischemic heart disease, and Chagasic and dilated cardiomyopathy. All trials are multicenter, randomized, double-blind and placebo controlled. In each trial 300 patients will be enrolled and receive optimized therapy for their specific condition. Additionally, half of the patients will receive the autologous bone marrow cells while the other half will receive placebo (saline with 5% autologous serum). For each trial there are specific inclusion and exclusion criteria and the method for cell delivery is intramyocardial for the chronic ischemic heart disease and intracoronary for all others. Primary endpoint for all studies will be the difference in ejection fraction (determined by Simpson's rule) six and twelve months after intervention in relation to the basal ejection fraction. The main hypothesis of this study is that the patients who receive the autologous bone-marrow stem cell implant will have after a 6 month follow-up a mean increase of 5% in absolute left ventricular ejection fraction in comparison with the control group. Discussion Many phase I clinical trials using cell therapy for cardiac diseases have already been performed. The few randomized studies have yielded conflicting results, rendering necessary larger well controlled trials to test for efficacy of cell therapies in cardiopathies. The trials registration numbers at the NIH registry are the following: Chagasic cardiomyopathy (NCT00349271), dilated cardiomyopathy (NCT

  2. Multicenter randomized trial of cell therapy in cardiopathies – MiHeart Study

    Directory of Open Access Journals (Sweden)

    Oliveira Sérgio A

    2007-01-01

    Full Text Available Abstract Background Cardiovascular diseases are the major cause of death in the world. Current treatments have not been able to reverse this scenario, creating the need for the development of new therapies. Cell therapies have emerged as an alternative for cardiac diseases of distinct causes in experimental animal studies and more recently in clinical trials. Method/Design We have designed clinical trials to test for the efficacy of autologous bone marrow derived mononuclear cell therapies in four different cardiopathies: acute and chronic ischemic heart disease, and Chagasic and dilated cardiomyopathy. All trials are multicenter, randomized, double-blind and placebo controlled. In each trial 300 patients will be enrolled and receive optimized therapy for their specific condition. Additionally, half of the patients will receive the autologous bone marrow cells while the other half will receive placebo (saline with 5% autologous serum. For each trial there are specific inclusion and exclusion criteria and the method for cell delivery is intramyocardial for the chronic ischemic heart disease and intracoronary for all others. Primary endpoint for all studies will be the difference in ejection fraction (determined by Simpson's rule six and twelve months after intervention in relation to the basal ejection fraction. The main hypothesis of this study is that the patients who receive the autologous bone-marrow stem cell implant will have after a 6 month follow-up a mean increase of 5% in absolute left ventricular ejection fraction in comparison with the control group. Discussion Many phase I clinical trials using cell therapy for cardiac diseases have already been performed. The few randomized studies have yielded conflicting results, rendering necessary larger well controlled trials to test for efficacy of cell therapies in cardiopathies. The trials registration numbers at the NIH registry are the following: Chagasic cardiomyopathy (NCT00349271

  3. Beautiful small: Misleading large randomized controlled trials? The example of colloids for volume resuscitation

    Directory of Open Access Journals (Sweden)

    Christian J Wiedermann

    2015-01-01

    Full Text Available In anesthesia and intensive care, treatment benefits that were claimed on the basis of small or modest-sized trials have repeatedly failed to be confirmed in large randomized controlled trials. A well-designed small trial in a homogeneous patient population with high event rates could yield conclusive results; however, patient populations in anesthesia and intensive care are typically heterogeneous because of comorbidities. The size of the anticipated effects of therapeutic interventions is generally low in relation to relevant endpoints. For regulatory purposes, trials are required to demonstrate efficacy in clinically important endpoints, and therefore must be large because clinically important study endpoints such as death, sepsis, or pneumonia are dichotomous and infrequently occur. The rarer endpoint events occur in the study population; that is, the lower the signal-to-noise ratio, the larger the trials must be to prevent random events from being overemphasized. In addition to trial design, sample size determination on the basis of event rates, clinically meaningful risk ratio reductions and actual patient numbers studied are among the most important characteristics when interpreting study results. Trial size is a critical determinant of generalizability of study results to larger or general patient populations. Typical characteristics of small single-center studies responsible for their known fragility include low variability of outcome measures for surrogate parameters and selective publication and reporting. For anesthesiology and intensive care medicine, findings in volume resuscitation research on intravenous infusion of colloids exemplify this, since both the safety of albumin infusion and the adverse effects of the artificial colloid hydroxyethyl starch have been confirmed only in large-sized trials.

  4. Beautiful small: Misleading large randomized controlled trials? The example of colloids for volume resuscitation.

    Science.gov (United States)

    Wiedermann, Christian J; Wiedermann, Wolfgang

    2015-01-01

    In anesthesia and intensive care, treatment benefits that were claimed on the basis of small or modest-sized trials have repeatedly failed to be confirmed in large randomized controlled trials. A well-designed small trial in a homogeneous patient population with high event rates could yield conclusive results; however, patient populations in anesthesia and intensive care are typically heterogeneous because of comorbidities. The size of the anticipated effects of therapeutic interventions is generally low in relation to relevant endpoints. For regulatory purposes, trials are required to demonstrate efficacy in clinically important endpoints, and therefore must be large because clinically important study endpoints such as death, sepsis, or pneumonia are dichotomous and infrequently occur. The rarer endpoint events occur in the study population; that is, the lower the signal-to-noise ratio, the larger the trials must be to prevent random events from being overemphasized. In addition to trial design, sample size determination on the basis of event rates, clinically meaningful risk ratio reductions and actual patient numbers studied are among the most important characteristics when interpreting study results. Trial size is a critical determinant of generalizability of study results to larger or general patient populations. Typical characteristics of small single-center studies responsible for their known fragility include low variability of outcome measures for surrogate parameters and selective publication and reporting. For anesthesiology and intensive care medicine, findings in volume resuscitation research on intravenous infusion of colloids exemplify this, since both the safety of albumin infusion and the adverse effects of the artificial colloid hydroxyethyl starch have been confirmed only in large-sized trials. PMID:26330723

  5. Cluster randomized trials utilizing primary care electronic health records : methodological issues in design, conduct, and analysis (eCRT Study)

    NARCIS (Netherlands)

    Gulliford, Martin C; van Staa, Tjeerd P; McDermott, Lisa; McCann, Gerard; Charlton, Judith; Dregan, Alex

    2014-01-01

    BACKGROUND: There is growing interest in conducting clinical and cluster randomized trials through electronic health records. This paper reports on the methodological issues identified during the implementation of two cluster randomized trials using the electronic health records of the Clinical Prac

  6. Huangqi Guizhi Wuwu Decoction for treating diabetic peripheral neuropathy: a meta-analysis of 16 randomized controlled trials

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    Bing Pang

    2016-01-01

    Conclusion: HGWWD treatment improves diabetic neurologic symptoms and ameliorates nerve conduction velocities. Our study suggests that HGWWD may have significant therapeutic efficacy for the treatment of diabetic peripheral neuropathy. However, the methodological quality of the randomized controlled trials was generally low. Larger and better-designed randomized controlled trials are required to more reliably assess the clinical effectiveness of HGWWD.

  7. The effect of hormone replacement therapy on serum homocysteine levels in perimenopausal women : a randomized controlled trial

    NARCIS (Netherlands)

    Hak, AE; Bak, AAA; Lindemans, J; Planellas, J; Bennink, HJTC; Hofman, A; Grobbee, DE; Witteman, JCM

    2001-01-01

    Serum homocysteine levels may be lowered by hormone replacement therapy, but randomized controlled trial data are scarce. We performed a single center randomized placebo-controlled trial to assess the 6 months effect of hormone replacement therapy compared with placebo on fasting serum homocysteine

  8. Effect of fish oil on heart rate in humans. A meta-analysis of randomized controlled trials

    NARCIS (Netherlands)

    Mozaffarian, D.; Geelen, A.; Brouwer, I.A.; Geleijnse, J.M.; Katan, M.B.; Zock, P.L.

    2005-01-01

    Background - The effect of fish oil on heart rate (HR), a major risk factor for sudden death, is not well established. We calculated this effect in a meta-analysis of randomized, double-blind, placebo- controlled trials in humans. Methods and Results - Randomized trials of fish oil that evaluated HR

  9. 78 FR 63479 - Meta-Analyses of Randomized Controlled Clinical Trials (RCTs) for the Evaluation of Risk To...

    Science.gov (United States)

    2013-10-24

    ... HUMAN SERVICES Food and Drug Administration Meta-Analyses of Randomized Controlled Clinical Trials (RCTs... scientific approaches for the conduct and assessment of meta-analyses of randomized controlled clinical trials (RCTs) to evaluate safety risks associated with the use of human drugs or biological...

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

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    Paajanen Hannu

    2013-02-01

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

  12. Can user testing of a clinical trial patient information sheet make it fit-for-purpose? - a randomized controlled trial

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    Silcock Jonathan

    2011-07-01

    Full Text Available Abstract Background The participant information sheet (PIS provided to potential trial participants is a critical part of the process of valid consent. However, there is long-standing concern that these lengthy and complex documents are not fit-for-purpose. This has been supported recently through the application of a performance-based approach to testing and improving readability called user testing. This method is now widely used to improve patient medicine leaflets - determining whether people can find and understand key facts. This study applied for the first time a controlled design to determine whether a PIS developed through user testing had improved readability over the original, using a sheet from a UK trial in acute myeloid leukemia (AML16. Methods In the first phase the performance of the original PIS was tested on people in the target group for the trial. There were three rounds of testing including 50 people in total - with the information revised according to its performance after each of the first 2 rounds. In the second phase, the revised PIS was compared with the original in a parallel groups randomised controlled trial (RCT A total of 123 participants were recruited and randomly allocated to read one version of the PIS to find and show understanding of 21 key facts. Results The first, developmental phase produced a revised PIS significantly altered in its wording and layout. In the second, trial phase 66% of participants who read the revised PIS were able to show understanding of all aspects of the trial, compared with 15% of those reading the original version (Odds Ratio 11.2; Chi-square = 31.5 p p Conclusions The original PIS for the AML16 trial may not have enabled valid consent. Combining performance-based user testing with expertise in writing for patients and information design led to a significantly improved and preferred information sheet. User testing is an efficient method for indicating strengths and weaknesses in

  13. School playground surfacing and arm fractures in children: a cluster randomized trial comparing sand to wood chip surfaces.

    Directory of Open Access Journals (Sweden)

    Andrew W Howard

    2009-12-01

    Full Text Available BACKGROUND: The risk of playground injuries, especially fractures, is prevalent in children, and can result in emergency room treatment and hospital admissions. Fall height and surface area are major determinants of playground fall injury risk. The primary objective was to determine if there was a difference in playground upper extremity fracture rates in school playgrounds with wood fibre surfacing versus granite sand surfacing. Secondary objectives were to determine if there were differences in overall playground injury rates or in head injury rates in school playgrounds with wood fibre surfacing compared to school playgrounds with granite sand surfacing. METHODS AND FINDINGS: The cluster randomized trial comprised 37 elementary schools in the Toronto District School Board in Toronto, Canada with a total of 15,074 students. Each school received qualified funding for installation of new playground equipment and surfacing. The risk of arm fracture from playground falls onto granitic sand versus onto engineered wood fibre surfaces was compared, with an outcome measure of estimated arm fracture rate per 100,000 student-months. Schools were randomly assigned by computer generated list to receive either a granitic sand or an engineered wood fibre playground surface (Fibar, and were not blinded. Schools were visited to ascertain details of the playground and surface actually installed and to observe the exposure to play and to periodically monitor the depth of the surfacing material. Injury data, including details of circumstance and diagnosis, were collected at each school by a prospective surveillance system with confirmation of injury details through a validated telephone interview with parents and also through collection (with consent of medical reports regarding treated injuries. All schools were recruited together at the beginning of the trial, which is now closed after 2.5 years of injury data collection. Compliant schools included 12 schools

  14. Psychiatric treatment following participation in the CapOpus randomized trial for patients with comorbid cannabis use disorder and psychosis

    DEFF Research Database (Denmark)

    Hjorthøj, Carsten Rygaard; Orlovska, Sonja; Fohlmann, Allan;

    2013-01-01

    Randomized trials targeting cannabis use disorders in patients with psychosis have generally been unsuccessful. One of the largest such trials was the CapOpus trial, which had an impact on the number of monthly joints used, but not on the number of days with cannabis use or positive or negative...

  15. What differences are detected by superiority trials or ruled out by noninferiority trials? A cross-sectional study on a random sample of two-hundred two-arms parallel group randomized clinical trials

    Directory of Open Access Journals (Sweden)

    Courvoisier Delphine S

    2010-10-01

    Full Text Available Abstract Background The smallest difference to be detected in superiority trials or the largest difference to be ruled out in noninferiority trials is a key determinant of sample size, but little guidance exists to help researchers in their choice. The objectives were to examine the distribution of differences that researchers aim to detect in clinical trials and to verify that those differences are smaller in noninferiority compared to superiority trials. Methods Cross-sectional study based on a random sample of two hundred two-arm, parallel group superiority (100 and noninferiority (100 randomized clinical trials published between 2004 and 2009 in 27 leading medical journals. The main outcome measure was the smallest difference in favor of the new treatment to be detected (superiority trials or largest unfavorable difference to be ruled out (noninferiority trials used for sample size computation, expressed as standardized difference in proportions, or standardized difference in means. Student t test and analysis of variance were used. Results The differences to be detected or ruled out varied considerably from one study to the next; e.g., for superiority trials, the standardized difference in means ranged from 0.007 to 0.87, and the standardized difference in proportions from 0.04 to 1.56. On average, superiority trials were designed to detect larger differences than noninferiority trials (standardized difference in proportions: mean 0.37 versus 0.27, P = 0.001; standardized difference in means: 0.56 versus 0.40, P = 0.006. Standardized differences were lower for mortality than for other outcomes, and lower in cardiovascular trials than in other research areas. Conclusions Superiority trials are designed to detect larger differences than noninferiority trials are designed to rule out. The variability between studies is considerable and is partly explained by the type of outcome and the medical context. A more explicit and rational approach to

  16. A simple method for analyzing data from a randomized trial with a missing binary outcome

    Directory of Open Access Journals (Sweden)

    Freedman Laurence S

    2003-05-01

    Full Text Available Abstract Background Many randomized trials involve missing binary outcomes. Although many previous adjustments for missing binary outcomes have been proposed, none of these makes explicit use of randomization to bound the bias when the data are not missing at random. Methods We propose a novel approach that uses the randomization distribution to compute the anticipated maximum bias when missing at random does not hold due to an unobserved binary covariate (implying that missingness depends on outcome and treatment group. The anticipated maximum bias equals the product of two factors: (a the anticipated maximum bias if there were complete confounding of the unobserved covariate with treatment group among subjects with an observed outcome and (b an upper bound factor that depends only on the fraction missing in each randomization group. If less than 15% of subjects are missing in each group, the upper bound factor is less than .18. Results We illustrated the methodology using data from the Polyp Prevention Trial. We anticipated a maximum bias under complete confounding of .25. With only 7% and 9% missing in each arm, the upper bound factor, after adjusting for age and sex, was .10. The anticipated maximum bias of .25 × .10 =.025 would not have affected the conclusion of no treatment effect. Conclusion This approach is easy to implement and is particularly informative when less than 15% of subjects are missing in each arm.

  17. Eligibility audits for the randomized neuropathic bone pain trial (TROG 96.05)

    International Nuclear Information System (INIS)

    In February 1996 the Trans-Tasman Radiation Oncology Group (TROG) initiated a two-arm, multicentre, prospective randomized trial on radiotherapy for neuropathic pain due to bone metastases (TROG 96.05). This trial compares the response to a single 8-Gy fraction with 20 Gy in five fractions. The accrual target is 270 patients. In order to evaluate compliance with eligibility criteria after approximately 1 year of accrual, an independent audit of the first 42 randomized patients was commissioned. This found that only one of these patients did not have genuine neuropathic pain, but that this patient and seven others (19%) had infringements of other eligibility/exclusion criteria for the trial. Accordingly it was decided to continue the full audit up to 90 patients. This detected no further patients without genuine neuropathic pain, and found only one other eligibility infringement (1/48; 2%). It is concluded that this quality assurance (QA) measure undertaken early in the trial led to significantly improved clinician awareness of, and compliance with, eligibility/exclusion criteria. It also enabled an accurate comparison of outcome data for all randomized versus all eligible patients at the time of the preplanned first interim analysis at 90 patients. In view of the excellent compliance demonstrated in the second audit, a one-in-five sampling is proposed for future audits from centres that have already accrued at least five consecutive eligible patients. This is consistent with TROG QA guidelines now operational. Copyright (2000) Blackwell Science Pty Ltd

  18. Single- versus two- layer intestinal anastomosis: a meta-analysis of randomized controlled trials

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    Taji Yoshinori

    2006-01-01

    Full Text Available Abstract Background To compare single- with two- layer intestinal anastomosis after intestinal resection: a meta-analysis of randomized controlled trials. Methods Randomized controlled trials comparing single- with two-layer intestinal anastomosis were identified using a systematic search of Medline, Embase and the Cochrane Library Databases covering articles published from 1966 to 2004. Outcome of primary interest was postoperative leak. A risk ratio for trial outcomes and weighted pooled estimates for data were calculated. A fixed-effect model weighted using Mantel-Haenszel methods and a random-effect model using DerSimonian-Laird methods were employed. Results Six trials were analyzed, comprising 670 participants (single-layer group, n = 299; two-layer group, n = 371. Data on leaks were available from all included studies. Combined risk ratio using DerSimonian-Laird methods was 0.91 (95% CI = 0.49 to 1.69, and indicated no significant difference. Inter-study heterogeneity was significant (χ2 = 10.5, d.f. = 5, p = 0.06. Conclusion No evidence was found that two-layer intestinal anastomosis leads to fewer post-operative leaks than single layer. Considering duration of the anastomosis procedure and medical expenses, single-layer intestinal anastomosis appears to represent the optimal choice for most surgical situations.

  19. 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

    Objective To synthesise evidence on the average bias and heterogeneity associated with reported methodological features of randomized trials. Design Systematic review of meta-epidemiological studies. Methods 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 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. Conclusions 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. PMID:27398997

  20. Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS Trial: study protocol for a randomized controlled trial

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    Dörr Jan

    2012-02-01

    Full Text Available Abstract Background Multiple sclerosis is the most common chronic inflammatory disease of the central nervous system in young adults. Despite the fact that numerous lines of evidence link both the risk of disease development and the disease course to the serum level of 25-hydroxyvitamin D it still remains elusive whether multiple sclerosis patients benefit from boosting the serum level of 25-hydroxyvitamin D, mainly because interventional clinical trials that directly address the therapeutic effects of vitamin D in multiple sclerosis are sparse. We here present the protocol of an interventional clinical phase II study to test the hypothesis, that high-dose vitamin D supplementation of multiple sclerosis patients is safe and superior to low-dose supplementation with respect to beneficial therapeutic effects. Methods/Design The EVIDIMS trial is a German multi-center, stratified, randomized, controlled and double-blind clinical phase II pilot study. Eighty patients with the diagnosis of definite multiple sclerosis or clinically isolated syndrome who are on a stable immunomodulatory treatment with interferon-β1b will be randomized to additionally receive either high-dose (average daily dose 10.200 IU or low-dose (average daily dose 200 IU cholecalciferol for a total period of 18 months. The primary outcome measure is the number of new lesions detected on T2-weighted cranial MRI at 3 tesla. Secondary endpoints include additional magnetic resonance imaging and optical coherence tomography parameters for neuroinflammation and -degeneration, clinical parameters for disease activity, as well as cognition, fatigue, depression, and quality of life. Safety and tolerability of high-dose vitamin D supplementation are further outcome parameters. Discussion In light of the discrepancy between existing epidemiological and preclinical data on the one hand and available clinical data on the other the EVIDIMS trial will substantially contribute to the evaluation

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

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    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.

  2. Auricular acupressure on specific points for hemodialysis patients with insomnia: a pilot randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Chuan Zou

    Full Text Available To assess the feasibility and acceptability of a randomized controlled trial compared auricular acupressure (AA on specific acupoints with AA on non-specific acupoints for treating maintenance hemodialysis (MHD patients with insomnia.Sixty three (63 eligible subjects were randomly assigned into either AA group received AA on specific acupoints (n=32, or sham AA (SAA group received AA on points irrelevant to insomnia treatment (n=31 for eight weeks. All participants were followed up for 12 weeks after treatments. The primary outcome was clinical response at eight weeks after randomization, defined as a reduction of Pittsburgh Sleep Quality Index (PSQI global score by 3 points and more.Fifty-eight (58 participants completed the trial and five dropped out. Twenty participants in AA group (62.5% and ten in SAA group (32.3% responded to the eight-week interventions (χ2 = 5.77, P = 0.02. PSQI global score declined 3.75 ± 4.36 (95%CI -5.32, -2.18 and 2.26 ± 3.89 (95%CI -3.68, -0.83 in AA group and SAA group respectively. Three participants died during the follow-up period. No evidence supported their deaths were related to the AA intervention. No other adverse event was observed.Feasibility and logistics of patient recruitment, randomization procedure, blinding approach, interventions application and outcome assessment had been tested in this pilot trial. The preliminary data appeared to show a favorable result on AA treatment. A full-scale trial is warranted.Chinese Clinical Trial Registry ChiCTR-TRC-12002272.

  3. 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.

  4. Completion report : Effect of Comprehensive Yogic Breathing program on type 2 diabetes: A randomized control trial

    Directory of Open Access Journals (Sweden)

    V P Jyotsna

    2014-01-01

    Full Text Available Background: Yoga has been shown to be benefi cial in diabetes in many studies, though randomized control trials are few. The aim of this randomized control trial was to see the effect of Sudarshan Kriya and related practices (comprehensive yogic breathing program on quality of life, glycemic control, and cardiac autonomic functions in diabetes. Diabetes mellitus is a risk factor for sudden cardiac death. Cardiac autonomic neuropathy has been implicated in the causation of sudden cardiac death. Therefore, a maneuver to prevent progression of cardiac autonomic neuropathy holds signifi cance. Materials and Methods: A total of 120 patients of diabetes on oral medication and diet and exercise advice were randomized into two groups: (1 Continued to receive standard treatment for diabetes. (2 Patients administered comprehensive yogic breathing program and monitored to regularly practice yoga in addition to standard treatment of diabetes. At 6 months, quality of life and postprandial plasma glucose signifi cantly improved in the group practicing yoga compared to baseline, but there was no significant improvement in the fasting plasma glucose and glycated hemoglobin. Results: On per protocol analysis, sympathetic cardiac autonomic functions signifi cantly improved from baseline in the group practicing comprehensive yogic breathing. Conclusion: This randomized control trial points towards the beneficial effect of yogic breathing program in preventing progression of cardiac neuropathy. This has important implications as cardiac autonomic neuropathy has been considered as one of the factors for sudden cardiac deaths.Keywords: comprehensive yogic breathing program, diabetes mellitus, cardiac autonomic function

  5. A cluster randomized controlled trial of the effectiveness and cost-effectiveness of Intermediate Care Clinics for Diabetes (ICCD: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Armstrong Natalie

    2012-09-01

    Full Text Available Abstract Background World-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs rather than hospital specialists. Intermediate care clinics for diabetes (ICCD potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1 compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2 assess the cost-effectiveness of the intervention; and (3 explore the views and experiences of patients, health professionals and other stakeholders. Methods/Design This two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention or to hospital care (control. Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice. or Control group: Standard GP care, with referral to secondary care as required, but no access to ICCD. Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (≤7.0%; blood pressure ( Discussion Forty-nine practices have been randomized, 1,997 patients have been recruited to the trial, and 20 patients have been recruited to the qualitative study. Results will be available late 2012

  6. 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

    BACKGROUND: The mortality rate of maintenance hemodialysis (MHD) patients remains high. Measures of protein-energy wasting, including hypoalbuminemia, are strongly associated with their high mortality. Growth hormone (GH) may improve lean body mass (LBM) and serum albumin levels, and health......, 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...

  7. RARtool : A MATLAB Software Package for Designing Response-Adaptive Randomized Clinical Trials with Time-to-Event Outcomes

    OpenAIRE

    Yevgen Ryeznik; Oleksandr Sverdlov; Weng Kee Wong

    2015-01-01

    Response-adaptive randomization designs are becoming increasingly popular in clinical trial practice. In this paper, we present RARtool, a user interface software developed in MATLAB for designing response-adaptive randomized comparative clinical trials with censored time-to-event outcomes. The RARtool software can compute different types of optimal treatment allocation designs, and it can simulate response-adaptive randomization procedures targeting selected optimal allocations. Through simu...

  8. Correction: PAIS: paracetamol (acetaminophen in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN74418480

    Directory of Open Access Journals (Sweden)

    Kappelle L Jaap

    2008-11-01

    Full Text Available Abstract Background The Paracetamol (Acetaminophen In Stroke (PAIS study is a phase III multicenter, double blind, randomized, placebo-controlled clinical trial of high-dose acetaminophen in patients with acute stroke. The trial compares treatment with a daily dose of 6 g acetaminophen, started within 12 hours after the onset of symptoms, with matched placebo. The purpose of this study is to assess whether treatment with acetaminophen for 3 days will result in improved functional outcome through a modest reduction in body temperature and prevention of fever. The previously planned statistical analysis based on a dichotomization of the scores on the modified Rankin Scale (mRS may not make the most efficient use of the available baseline information. Therefore, the planned primary analysis of the PAIS study has been changed from fixed dichotomization of the mRS to a sliding dichotomy analysis. Methods Instead of taking a single definition of good outcome for all patients, the definition is tailored to each individual patient's baseline prognosis on entry into the trial. Conclusion The protocol change was initiated because of both advances in statistical approaches and to increase the efficiency of the trial by improving statistical power. Trial Registration Current Controlled Trials [ISCRTN74418480

  9. Transcutaneous electrical nerve stimulation for the management of tennis elbow: a pragmatic randomized controlled trial: the TATE trial (ISRCTN 87141084

    Directory of Open Access Journals (Sweden)

    Warlow Catherine

    2009-12-01

    Full Text Available Abstract Background Tennis elbow is a common and often extremely painful musculoskeletal condition, which has considerable impact on individuals as well as economic implications for healthcare utilization and absence from work. Many management strategies have been studied in clinical trials. Whilst corticosteroid injections offer short term pain relief, this treatment is unpleasant and is used with caution due to an associated high risk of pain recurrence in the long term. Systematic reviews conclude that there is no clear and effective treatment for symptoms of pain in the first 6 weeks of the condition. There is a clear need for an intervention that is acceptable to patients and provides them with effective short-term pain relief without increasing the risk of recurrence. Transcutaneous electrical nerve stimulation (TENS is an inexpensive, non-invasive, non-pharmacological form of analgesia that is commonly used in the treatment of pain. TENS has very few contraindications and is simple to apply. It also benefits from being patient controlled, thereby promoting self-management. This study aims to assess the effectiveness, in terms of pain relief, and cost-effectiveness of a self-management package of treatment that includes TENS. Methods/Design The design of the study will be a two-group pragmatic randomized clinical trial. 240 participants aged 18 years and over with tennis elbow will be recruited from 20-30 GP practices in Staffordshire, UK. Participants are to be randomized on a 1:1 basis to receive either primary care management (standard GP consultation, medication, advice and education or primary care management with the addition of TENS, over 6 weeks. Our primary outcome measure is average intensity of elbow pain in the past 24 hours (0-10 point numerical rating scale at 6 weeks. Secondary outcomes include pain and limitation of function, global assessment of change, days of sick leave, illness perceptions, and overall health status. A

  10. A randomized trial evaluating a block-replacement regimen during radioiodine therapy

    DEFF Research Database (Denmark)

    Bonnema, Steen J; Grupe, Peter; Boel-Jørgensen, Henrik;

    2011-01-01

    Eur J Clin Invest 2010 ABSTRACT: Background  Lack of consensus regarding the antithyroid drug regimen in relation to radioiodine ((131) I) therapy of hyperthyroidism prompted this randomized trial comparing two strategies. Design  Patients with Graves' disease (GD, n = 51) or toxic nodular goitre...... (TNG, n = 49) were randomized to (131) I either 8 days following discontinuation of methimazole (-BRT, n = 52, median dose: 5 mg) or while on a continuous block-replacement regimen (+BRT, n = 48, median dose 15 mg methimazole and 100 μg levothyroxine). Results  Patients in the +BRT group required more...

  11. Propensity scores used for analysis of cluster randomized trials with selection bias: a simulation study.

    Science.gov (United States)

    Leyrat, C; Caille, A; Donner, A; Giraudeau, B

    2013-08-30

    Cluster randomized trials (CRTs) are often prone to selection bias despite randomization. Using a simulation study, we investigated the use of propensity score (PS) based methods in estimating treatment effects in CRTs with selection bias when the outcome is quantitative. Of four PS-based methods (adjustment on PS, inverse weighting, stratification, and optimal full matching method), three successfully corrected the bias, as did an approach using classical multivariable regression. However, they showed poorer statistical efficiency than classical methods, with higher standard error for the treatment effect, and type I error much smaller than the 5% nominal level. PMID:23553813

  12. Impact of Seed Voucher System on Rice Farmers’ Welfare in Nigeria: A Randomized Control Trial Approach

    OpenAIRE

    Awotide, Bola Amoke; Awoyemi, Taiwo Timothy; Diagne, Aliou; Ojehomon, Vivian E.T.

    2012-01-01

    This study adopted Randomized Control Trial to examine the impact of seed voucher system on farming households’ welfare in Nigeria using cross-sectional data of 600 rice farmers randomly selected from the three major rice ecologies of Nigeria. The WALD estimate reveals that the use of seed voucher increased household Per Capita Expenditure (PCE) by N14705.91. While the result of the Local Average Treatment Effect (LATE), shows a positive and significant impact of N7928.15 on PCE. Therefore, t...

  13. Effects of nutrition education on weight gain prevention: a randomized controlled trial

    OpenAIRE

    Metzgar, Catherine J.; Nickols-Richardson, Sharon M.

    2016-01-01

    Background Body weight (BW) reduction through energy restriction is ineffective at impacting the obesity epidemic. Shifting from an obesity treatment to weight gain prevention focus may be more effective in decreasing the burden of adult obesity. Methods This was a 1-year randomized controlled trial of weight gain prevention in healthy premenopausal women, aged 18–45 y, with a body mass index (BMI) of >18.5 kg/m2. Eighty-seven women were randomized to a weight gain prevention intervention del...

  14. When is informed consent required in cluster randomized trials in health research?

    Directory of Open Access Journals (Sweden)

    Boruch Robert

    2011-09-01

    Full Text Available Abstract 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

  15. Multisystemic Therapy for Child Abuse and Neglect: A Randomized Effectiveness Trial

    OpenAIRE

    Swenson, Cynthia Cupit; Schaeffer, Cindy M.; Henggeler, Scott W.; Faldowski, Richard; Mayhew, Amy Marie

    2010-01-01

    The primary purpose of this study was to conduct a randomized effectiveness trial of Multisystemic Therapy for Child Abuse and Neglect (MST-CAN) for physically abused youth (mean age = 13.88 years, 55.8% female, 68.6% Black) and their families. Eighty-six families being followed by Child Protective Services due to physical abuse were randomly assigned to MST-CAN or Enhanced Outpatient Treatment (EOT), with both interventions delivered by therapists employed at a community mental health center...

  16. The optimal dose of vitamin D in growing girls during academic years: a randomized trial

    OpenAIRE

    SHAKINBA, Mehrdad; TEFAGH, Samane; NAFEI, Zahra

    2011-01-01

    Prevalence of vitamin D deficiency is remarkable during childhood and adolescence throughout the world. Sufficient intake of vitamin D contributes to a number of health outcomes. The aim of this study was to specify the optimal dose of vitamin D in growing girls in a Muslim country during an academic year. Materials and methods: This randomized clinical trial study was carried out in Yazd in the center of Iran in 2007;120 junior high school girls (aged 12-15 years) were randomly divided into...

  17. Long-Term Effects of Goshajinkigan in Prevention of Diabetic Complications: A Randomized Open-Labeled Clinical Trial

    Directory of Open Access Journals (Sweden)

    K. Watanabe

    2014-01-01

    Full Text Available Objective. This clinical trial was designed to investigate whether goshajinkigan reduces the onset of diabetic complications or not. Materials and Methods. A total of 332 type 2 diabetic mellitus patients were registered from 9 clinical centers from March 2000 to August 2007. Patients were randomly assigned to take goshajinkigan extract powder, 2.5 grams for 3 times a day or no kampo therapy, additionally to the regular treatment. The primary endpoints were the onset of macrovascular diseases or progression of nephropathy or retinopathy. Statistical analysis was performed by the intention-to-treat method. Results. After 5 years of observation, 116 patients were submitted to analysis. Among them, no macrovascular events were observed in both groups. Although 43 participants had upstaging of retinopathy or nephropathy in total, there was no significant difference between goshajinkigan group and control group. Deterioration of ankle reflex was suppressed in goshajinkigan group. Also glycated hemoglobin, and fasting plasma glucose were decreased in the goshajinkigan group. Conclusion. Although the power of analysis was too low to demonstrate any effects of goshajinkigan on the progression of macrovascular diseases, retinopathy or nephropathy, goshajinkigan may be beneficial for diabetic neuropathy and glycemic control.

  18. Optimizing foster family placement for infants and toddlers: A randomized controlled trial on the effect of the foster family intervention.

    Science.gov (United States)

    Van Andel, Hans; Post, Wendy; Jansen, Lucres; Van der Gaag, Rutger Jan; Knorth, Erik; Grietens, Hans

    2016-01-01

    The relationship between foster children and their foster carers comes with many risks and may be very stressful both for parents and children. We developed an intervention (foster family intervention [FFI]) to tackle these risks. The intervention focuses on foster children below the age of 5 years. The objective was to investigate the effects of FFI on the interactions between foster parents and foster children. A randomized control trial was carried out with a sample of 123 preschool aged children (mean age 18.8 months; 51% boys) and their foster carers. A pretest was carried out 6 to 8 weeks after placement and a posttest one half year later. Interactions were videotaped and coded using the Emotional Availability Scales (EAS). Foster carers were asked to fill in the Dutch version of the Parenting Stress Index. Morning and evening samples of children's salivary cortisol were taken. In the posttest, significantly positive effects were found on the following EAS subscales: Sensitivity, Structuring, Nonintrusiveness, and Responsiveness. We found no significant differences on stress levels of foster carers and children (Nijmeegse Ouderlijke Stress Index domains and salivary cortisol). This study shows that the FFI has a significant positive effect on parenting skills as measured with EAS and on Responsiveness of the foster child. Findings are discussed in terms of impact and significance relating to methodology and design of the study and to clinical relevance. (PsycINFO Database Record PMID:27196390

  19. Systematic review: glucocorticosteroids for alcoholic hepatitis - a Cochrane Hepato-Biliary Group systematic review with meta-analyses and trial sequential analyses of randomized clinical trials

    DEFF Research Database (Denmark)

    Rambaldi, A.; Saconato, H.H.; Christensen, E.;

    2008-01-01

    or hepatic encephalopathy and with low-bias risk. In all analyses, heterogeneity was significant and substantial. Trial sequential analyses using heterogeneity-adjusted information size demonstrated no significant effect of glucocorticosteroids on mortality. Weighted logistic regression analyses taking...... vs. placebo or no intervention for patients with alcoholic hepatitis. Methods We searched for randomized trials published before July 2007. The trials were assessed for risk of bias. Results We included 15 trials with a total of 721 randomized patients. The overall mortality rate was 39.5%. Twelve...... of the fifteen trials were at risk of bias. Glucocorticosteroids did not statistically reduce mortality compared with placebo or no intervention (relative risk 0.83, 95% CI 0.63-1.11). Glucocorticosteroids significantly reduced mortality in the subgroup of trials with patients with Maddrey's score of at least 32...

  20. The DEMO trial: a randomized, parallel-group, observer-blinded clinical trial of strength versus aerobic versus relaxation training for patients with mild to moderate depression

    DEFF Research Database (Denmark)

    2009-01-01

    OBJECTIVE: To assess the benefit and harm of exercise training in adults with clinical depression. METHOD: The DEMO trial is a randomized pragmatic trial for patients with unipolar depression conducted from January 2005 through July 2007. Patients were referred from general practitioners or psych......OBJECTIVE: To assess the benefit and harm of exercise training in adults with clinical depression. METHOD: The DEMO trial is a randomized pragmatic trial for patients with unipolar depression conducted from January 2005 through July 2007. Patients were referred from general practitioners......: Our findings do not support a biologically mediated effect of exercise on symptom severity in depressed patients, but they do support a beneficial effect of strength training on work capacity. TRIAL REGISTRATION: (ClinicalTrials.gov) Identifier: NCT00103415....